key: cord- -soqeje z authors: parry, christopher m.; peacock, sharon j. title: microbiology date: - - journal: hunter's tropical medicine and emerging infectious diseases doi: . /b - - - - . - sha: doc_id: cord_uid: soqeje z the management and containment of many treatable and preventable infectious diseases in resource-poor countries is limited by the failure to make an accurate diagnosis. most of the world's population lacks access to accurate, affordable, easy-to-use, quality-assured, reliable, and accessible diagnostic tests and misdiagnosis of infectious diseases is common and compromises patient care. laboratory diagnostics are also needed for the detection and surveillance of the increasing levels of antimicrobial resistance. accurate clinical diagnosis in resource-poor settings relies strongly on the laboratory service, and the need to support the development of a quality-assured laboratory service in such settings is increasingly recognized. international organizations are actively working with local and national providers to improve laboratory services. the development of laboratory services will contribute to improved health for the local population, protection against emerging pathogens, and ensure better use of scarce health care resources. christopher m. parry, sharon j. peacock support. diagnostic algorithms have been developed for situations with no laboratory backup, an approach adopted, for example, in the integrated management of childhood illness (imci). unfortunately, for many infections, clinical features lack sufficient specificity to allow them to be used to differentiate the possible diagnoses, and over-treatment to cover the various possibilities is common. in the assessment of the febrile child in the tropics, for example, malaria and systemic bacterial infections often have an indistinguishable clinical picture. malaria may be diagnosed by smear microscopy, but bloodstream infections require a blood culture service. it has become clear in recent years that bloodstream infections represent an underappreciated burden of disease and mortality. this was clearly demonstrated by a study conducted in kenya in which bacterial bloodstream infections diagnosed by blood culture were responsible for % of deaths among children admitted to a rural district hospital. without an accurate diagnosis and specific treatment, bloodstream infections such as those due to salmonella enterica, staphylococcus aureus, streptococcus pneumoniae, or burkholderia pseudomallei can carry a high mortality. distinguishing cerebral malaria, bacterial meningitis, and encephalopathic typhoid may be similarly difficult without laboratory support. children in sub-saharan africa with clinical symptoms of pneumonia may have pneumococcal pneumonia but can equally have malaria or invasive salmonellosis. a child with dysentery may be suffering from amebic colitis, shigella infection, or enterohemorrhagic escherichia coli. in adults, syndromic management of sexually transmitted infections is widespread but needs to be informed by periodic surveillance of antimicrobial susceptibility patterns. emerging and potentially epidemic viral infections such as severe acute respiratory syndrome (sars), influenza (h n and h n ), ebola, and zika require relatively sophisticated tests to confirm the diagnosis. infections by pathogens that are resistant to multiple antimicrobials are common in many tropical countries where there is widespread availability of over-the-counter antimicrobials. appropriate therapy of these infections requires isolation of the causative organism and antimicrobial susceptibility testing. laboratories also have an important public health role within the health care system. the ability to investigate outbreaks of disease as part of epidemic preparedness is a key function. these might include outbreaks of watery or bloody diarrhea, epidemics of meningitis, or clusters of patients with fever of unknown etiology. in addition, laboratories are a critical component of disease control programs such as the national programs for the control of tuberculosis, hiv, and malaria. the lack of laboratory capacity to support the expansion of diagnostic testing and antiretroviral therapy in hiv programs and in disease outbreaks such as ebola has made many international organizations appreciate the desperate plight of the laboratory service for the first time. tuberculosis can be diagnosed in many patients with a ziehl-neelsen-stained smear of sputum, but to extend the diagnosis in those who are acid-fast bacilli (afb) negative or have multi-drug-resistant (mdr) disease requires more developed laboratory support. furthermore, laboratories have an increasing role in infection control in health care settings and congregate facilities and in the prevention of health care-associated infections. accurate disease surveillance requires a laboratory network and is vital to inform public health policy concerning allocation of resources and disease prevention. laboratories can help to • accurate diagnosis in resource-poor settings is severely limited by the absence of good diagnostic laboratory services. • laboratories in resource-restricted settings struggle with poor facilities, lack of reliable water and electricity, inadequate equipment and consumables, insufficient staff, poor training and low morale, absence of standard operating procedures and quality assurance programs, and inadequate levels of biosafety. • a country plan for the development of a laboratory network requires consideration of the needs at primary, district, provincial/regional, and national levels. • at the district hospital level, a quality-assured repertoire of essential laboratory tests can contribute to improved health care. • surveillance by microbiology laboratories provides an understanding of the causes of infection in the local population and the levels of antimicrobial resistance in key pathogens, and informs public health policy on appropriate antimicrobial therapy and preventive strategies. • there is increasing recognition of the need to support the development of a quality-assured laboratory service in resource-restricted settings and develop simple and robust point-of-care diagnostics both for routine clinical care and outbreak response. • point-of-care rapid diagnostic tests are changing our approach to the diagnosis of some infectious diseases, but care needs to be taken about their usage and interpretation of results. the effective management and containment of many treatable and preventable infectious diseases in resource-restricted countries is limited by the failure to make an accurate diagnosis. access to accurate, affordable, easy-to-use, quality-assured, reliable, and accessible diagnostic tests is severely lacking for most of the world's population, and misdiagnosis of infectious diseases is common. disease identification, appropriate treatment choice, and implementing public health measures for the prevention and control of endemic and epidemic infections all require laboratory support. this lack of reliable diagnostics compromises patient care. laboratory diagnosis also highlights the increasing levels of resistance to antimicrobials in many infections and the need for newer, possibly unaffordable, antimicrobials such as broad-spectrum antimicrobials in bacterial sepsis, or second-line combination therapy for aids, malaria, and tuberculosis. this issue is increasingly recognized and being addressed in many regions. in most resource-restricted settings, individual patient diagnosis is based on clinical signs and symptoms with little or no laboratory be rudimentary so that specimens referred to the next level are not transported in a timely manner and results do not return in a time period that will influence clinical management. it is standard practice in tuberculosis programs that patients who fail treatment should have a sample cultured for tuberculosis so that susceptibility tests can be performed. in a study of the transport of such specimens to the central reference laboratory in malawi, only % of specimens arrived in the reference laboratory and only % of those samples received were successfully cultured for susceptibility testing. the shortage of staff with appropriate education and training is a further problem. many laboratory workers have no formal training and are simply trained at the bench. at the peripheral level, there may be only one laboratory assistant, with no more than secondary school education. at the district level, there may be assistants and technicians (formally educated in laboratory medicine for years). at the central level, technicians may work alongside technologists (with years specialist post-technician training) and scientists (university science graduates). regardless of qualifications, laboratory workers often have a lowly status within the health sector, and the attrition of health care personnel out of government service results in low morale among those who remain. private or research laboratories may attract the best technicians from the government sector. diagnostic laboratories frequently have no representation at the local, provincial, or national level, or, if they do, it is only as part of the support services. in many countries, the voice of the laboratory is rarely heard. these many problems contribute to a poor biosafety situation in laboratories. the lack of equipment, knowledge, and training means that laboratory workers are processing samples with hazardous pathogens in an unsafe manner. in a study of tuberculosis laboratories in korea, before safety conditions had been upgraded, the relative risk of being diagnosed with tuberculosis for the technicians performing drug susceptibility tests was . ( % ci . - . ) compared with non-laboratory workers. the true magnitude of this problem in laboratory workers is difficult to gauge because surveillance of infection in laboratory workers is rarely performed or reported. at a national level, the important contribution of laboratories needs to be appreciated within the ministry of health, by national and local health care managers, and by funding organizations. a representative of the laboratory services should be present in the key decision-making committees. support is also needed from clinicians, who often have disproportionate influence within the system. a plan for the laboratory network should become part of the overall health care development plan. there needs to be a priority list of core and essential services provided in a qualityassured manner. the laboratory plan should include the provision for a tiered laboratory network at the primary, district, regional/ provincial, and national levels. the plans should be realistic, affordable, and sustainable. at the level i or primary level, perhaps in a health post or health center serving outpatients, microscopy for malaria and tuberculosis and testing for hiv with a same-day service would be essential. these laboratories can serve as a collection point for samples that need referral to the next level. the level ii facility in the local district hospital would have a dedicated laboratory space and a broader repertoire of tests serving inpatients and outpatients. the tests offered would depend on the spectrum of local diseases and resources available, and may be limited to microscopy, simple biochemistry and serology, and blood transfusion, or may include bacterial culture facilities. laboratories can act as a hub for the primary-level laboratories, providing them with support, supplies of reagents, and qa activities. at the level iii, define clinical problems by sampling surveys. for example, determining the antimicrobial susceptibilities of bacterial pathogens such as s. aureus, s. pneumoniae, or s. enterica for a selection of isolates can inform the appropriate empiric therapy in a particular area. an understanding of the burden of disease in an area-drugresistant typhoid in an urban slum, for example-could lead to public health measures such as a vaccination program. laboratory surveillance programs may produce the clue to the possibility of new organisms emerging, including both bacteria and viruses, most commonly at the animal-human interface. at for many health care staff working in resource-restricted areas, the major problem is simply a lack of laboratory services. hospital laboratories may be absent, or, if they are available, only offer a limited repertoire of tests. in other areas, particularly in asia, a wide range of alternative services is offered by private diagnostic laboratories, typically outside the front gate of the hospital but with uncertain quality. even when the tests are available, they may not be used or the results ignored. lack of use may stem from a poor perception of the laboratory, and tests may not be available because the costs are prohibitive. even when laboratories are present, they face the many challenges that are familiar to all areas of the health care sector. inadequate facilities are common, with laboratories that lack space and a secure supply of electricity and water. appropriate equipment may be unavailable or poorly maintained. even basic equipment required for a functioning laboratory can be in disrepair because of the absence of regular care and servicing. a functioning microscope is a key piece of equipment for a basic microbiology laboratory but is frequently found in poor condition. in a survey of microscopes in laboratories in nine districts in malawi, only % were in good condition. there were . functioning microscopes per , population, and even microscopes in need of full servicing were still in daily use. the microscopes were from different manufacturers, illustrating the lack of standardization of laboratory equipment so frequently seen. the provision of biological safety cabinets is another area where equipment from multiple manufacturers and lack of spare parts and maintenance are common, and in this case may lead to unsafe and hazardous conditions for laboratory workers. standardization of equipment and consumables with central ordering, maintenance contracts, and supplies of spare parts would seem a sensible response to this issue but is rarely seen. tests may also be unavailable because of an inadequate supply route for consumables. this is another area where standardization of tests and central ordering and supply can lead not only to more reliable supply of quality-assured consumables but also to potential cost savings for the country. the laboratory can generate results, but the quality may be poor. standard operating procedures may be absent and quality control of routine procedures non-existent. the absence of national or regional laboratory guidelines or programs of external quality assurance (qa) by the laboratory network is common. communications between different levels within the laboratory network may laboratories are further categorized into biosafety levels (bsl) so that the facilities available are matched to the pathogens handled. a standard diagnostic laboratory would be at bsl , and the basic requirements for such a laboratory are outlined in table . and box . . more specialized laboratories such as tuberculosis reference laboratories where culture and susceptibility testing are performed require bsl facilities. bsl laboratories have particular design features to reduce the hazard of airborne transmission and incorporate directional airflows and the use of biological safety cabinets. they are particularly appropriate for laboratories handling pathogens such as tuberculosis and influenza. however, bsl facilities are very expensive and difficult to build and maintain. the who has recently indicated that in some circumstances, slightly less rigorous guidelines, so-called bsl + as outlined in table . , may be appropriate for selected laboratories, for example, processing samples for tuberculosis culture. health care staff working at the district hospital level may be asked to advise on what would constitute an appropriate laboratory service for the hospital and district. the provision of an extensive range of tests is likely to be unaffordable and impractical. in a study evaluating the role of the laboratory in a district hospital in malawi, the services considered essential were blood transfusion (including blood grouping and compatibility testing and screening for hiv, hepatitis b, and syphilis), hemoglobin estimation, and the microscopic diagnosis of malaria and tuberculosis. this list will vary in different areas, and the services of the laboratory should be orientated to the requirements of the district and the available resources. other tests that require relatively little investment and can be done where there are limited resources include microscopy of urine and stool samples for ova, cysts, and parasites; gram stain and cell count in cerebrospinal fluid and other sterile fluids; and gram stains of pus samples. the microscopic appearance of some typical bacterial pathogens is shown in fig. . a-f. guidelines for standard laboratory methods appropriate for resource-restricted areas are available. a checklist of issues that should be considered when evaluating a diagnostic laboratory is in box . . provincial or regional level, laboratories will be located in larger referral hospitals. laboratories at this level should be performing a more sophisticated range of tests with higher throughput. for example, facilities for tuberculosis culture might be available, together with molecular techniques for specific diseases and the ability to investigate disease outbreaks. support for the level ii laboratories would be an important function, including periodic visits and laboratory assessment as part of a qa program. national reference laboratories at level iv are likely to be located in the capital and serve specialized public health functions that may be linked to specific disease control programs such as the central reference laboratory for the national tuberculosis programme. it is important that laboratories at the national level have links to regional supranational reference laboratories for advice and quality assurance. level iii and iv laboratories would conduct surveillance and monitoring of infections using laboratory data collected throughout the network, establish standard operating procedures and protocols, conduct training and quality improvement, and plan for equipment needs and maintenance throughout the network. biosafety is an essential consideration at all levels of the laboratory network and depends on three principles. good laboratory practice and technique are fundamental and require established standard operating procedures and appropriate induction and training of staff. safety equipment provides a primary barrier, and this includes appropriate, properly maintained and used equipment (e.g., centrifuges, biological safety cabinets) and personal protective equipment (e.g., gloves, respirators). finally, facility design and construction are a secondary barrier providing, for example, appropriate workflows (from clean to dirty areas) and directional airflows and containment if required. microorganisms are categorized into four hazard groups according to their risk to individuals and society and the availability of treatment and preventive measures (table . the diagnosis of infection depends on detection of the pathogen or the host response to the pathogen. direct pathogen detection is traditionally performed by light microscopy, although antigen detection and nucleic acid amplification tests (such as polymerase chain reaction [pcr]) are increasingly used. pathogen detection may also be carried out by isolation of the microorganism by culture of relevant clinical samples, and this allows susceptibility testing to be performed. methods based on detecting the immune response mainly rely on detecting pathogen-specific igm or igg antibodies. technological advances in the design of testing methods have simplified antigen and antibody detection to the point that simple point-of-care test kits are now widely available. the rapid kits for hiv antibody detection have an established place in the voluntary counseling and testing framework being established in many countries. rapid malaria detection tests have been recommended as a replacement for malaria microscopy in some guidelines and need to be positive before antimalarial treatment is given. in recent years, organizations such as the unicef/united nations development programme/world bank/who special programme for research and training in tropical diseases (tdr), and the foundation for innovative new diagnostics (find) have played an important role in developing and evaluating new diagnostic tests for many tropical diseases. the who sexually transmitted diagnostics initiative has developed an approach to the characteristics of an ideal diagnostic test in the developingcountry context. "assured" tests should be affordable by those resistance surveillance system manual (e. coli, klebsiella pneumoniae, acinetobacter baumannii, s. aureus, s. pneumoniae, salmonella spp., shigella spp., and neisseria gonorrhoeae), as well as other pathogens of local or national importance. there have also been considerable advances in the format and ease of use of molecular tests. this is exemplified by the increasing use in tuberculosis laboratories of nucleic acid amplification tests directly from afb smear-positive sputum, or from culture isolates. line probe assays (lpas) use a multiplex pcr amplification followed by reverse hybridization to identify mycobacterium tuberculosis complex and mutations in the genes associated with at risk of infection, sensitive and specific, user friendly (simple to perform and requiring minimal training), rapid (to enable treatment at the first visit), robust (does not require refrigerated storage), equipment-free, and able to be delivered to those who need it. there has been increased attention on the problem of antimicrobial resistance for many important pathogens and the critical role that the laboratory plays in the management of this. initiatives have focused on methods and systems of surveillance of antimicrobial resistance in bacterial infections that countries can readily implement. , the who guideline has recommended a focus on eight priority pathogens as described in the global antimicrobial rifampicin and isoniazid resistance. lpa can be performed with results in to days, which is considerably quicker than the weeks required for traditional culture methods, and the overall agreement for the diagnosis of mdr between these tests and conventional methods is %. the format of these tests is being simplified so that the feasibility of their routine use in tuberculosis reference laboratories in developing countries is becoming a reality. these methods are an important component of the roll-out of the programmatic management of mdr tuberculosis globally. quality assurance is defined as "planned and systematic activities to provide adequate confidence that requirements for quality will be met." the qa system is the basis for a guaranteed result. if this system is not followed, patients may get the wrong results, with important consequences for their health-such as receiving inadequate treatment. a program of qa in diagnostic laboratories involves not only internal quality control and external qa but also attention to appropriate staffing, training and supervision, and maintenance of equipment and facilities. international guidelines are now available and increasingly implemented for qa in many areas of laboratory practice such as afb smear microscopy and hiv testing. accurate clinical diagnosis in resource-restricted settings relies strongly on the laboratory service. the increasing recognition of the need to support the development of a quality-assured laboratory service in such settings is therefore welcome. in many regions, international organizations are actively working with local providers to improve laboratory services. the development of laboratory services will contribute to improved health for the local population and ensure better use of scarce health care resources. bacteremia among children admitted to a rural hospital in kenya diagnostic preparedness for infectious disease outbreaks amr surveillance in low and middle-income settings -a roadmap for participation in the global antimicrobial surveillance system (glass) evaluation of microscope condition in malawi using a bus service for transporting sputum specimens to the central reference laboratory: effect on the routine tb culture service in malawi risk of occupational tuberculosis in national tuberculosis programme laboratories in korea world health organization (who) guidance on bio-safety related to tb laboratory diagnostic procedures the operation, quality and costs of a district hospital laboratory service in malawi medical laboratory manual for tropical countries diagnostics for the developing world world health organization: global antimicrobial resistance surveillance system: manual for early implementation key: cord- -pa v c authors: johns, gemma; tan, jacinta; burhouse, anna; ogonovsky, mike; rees, catrin; ahuja, alka title: a visual step-by-step guide for clinicians to use video consultations in mental health services: nhs examples of real-time practice in times of normal and pandemic healthcare delivery date: - - journal: nan doi: . /bjb. . sha: doc_id: cord_uid: pa v c despite the increasingly widespread use of video consultations, there are very few documented descriptions of how to set up and implement video consultations in real-time practice. this step-by-step guide will describe the set-up process based on the authors’ experience of two real-time national health service (nhs) examples: a single health board use (delivered in normal time), and an all-wales national video consultation service roll-out (delivered during an emergency pandemic as part of the covid- response). this paper provides a simple visual step-by-step guide for using telepsychiatry via the remote use of video consultations in mental health services, and outlines the mandatory steps to achieving a safe, successful and sustainable use of video consultations in the nhs by ensuring that video consultations fit into existing and new nhs workflow systems and adhere to legal and ethical guidelines. despite the increasingly widespread use of video consultations, there are very few documented descriptions of how to set up and implement video consultations in realtime practice. this step-by-step guide will describe the set-up process based on the authors' experience of two real-time national health service (nhs) examples: a single health board use (delivered in normal time), and an all-wales national video consultation service roll-out (delivered during an emergency pandemic as part of the covid- response). this paper provides a simple visual step-by-step guide for using telepsychiatry via the remote use of video consultations in mental health services, and outlines the mandatory steps to achieving a safe, successful and sustainable use of video consultations in the nhs by ensuring that video consultations fit into existing and new nhs workflow systems and adhere to legal and ethical guidelines. keywords video consultations; covid- ; telepsychiatry; mental health; digital health. there is a large and growing evidence base of published data that demonstrates an overall consensus of suitability, acceptability and satisfaction regarding the use of digital technology, - particularly video consultations for the purpose of remote assessments and appointments in mental health, known as 'telepsychiatry'. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] telepsychiatry is widely reported to be at least as efficient and effective as traditional face-to-face care, providing improved clinical and quality of life outcomes across a wide range of population groups and settings. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] studies have compared video consultations with standard in-person care and concluded that video consultations might be superior to in-person consultations for some forms of treatment and population groups. , the evidence base for telepsychiatry remains strong and consistent across mental health studies for both adult and child services. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] it is commonly argued that mental health and psychiatry are particularly well suited to video consultations and that the psychiatric interaction translates exceptionally well to the technological world. this is because many treatments are based on interpersonal 'talking therapies' and medication management, which typically do not require any other medical devices for clinical use, perhaps in contrast to other specialties. video consultations have the potential to offer many additional benefits to patients, families and clinicians besides treatment. they are reported to improve and widen patient and family access to healthcare, support co-production and self-management, increase efficiency and improve clinical outcomes, as well as significantly reducing clinical time and patient and family travel. , , local evidence to support this step-by-step guide the cwtch quality improvement project in , the health foundation funded aneurin bevan university health board (abuhb) for year to establish a telepsychiatry programme with the objective of providing mental health appointments to children and adolescents within gwent mental health services. this abuhb programme is called connecting with telehealth to children in hospital and healthcare (cwtch). it is a national health service (nhs) quality improvement project that provides faster and more efficient appointments in child and adolescent mental health services (camhs) using a communication platform called attend anywhere (https://www.attendanywhere. com). the programme tested the suitability and acceptability of telepsychiatry and measured satisfaction across a wide range of settings and uses, including paediatric wards for emergency assessments, out-patient appointments, medication reviews, autism assessments, school postvention clinics for pupil suicides, virtual groups and more. it demonstrated that telepsychiatry in camhs is a highly suitable adjunct to routine ways of working; once people became familiar with this way of holding appointments, it was rated as acceptable and satisfactory by patients, families and clinicians. , rebranding of cwtch and royal college of psychiatry endorsement cwtch has now been rebranded and is called cwtch cymru. it has received local and national recognition for its success and is now considered an exemplar of good practice across wales. cwtch cymru and its guiding principles have also been endorsed by the welsh royal college of psychiatrists. partnership and development of the national roll-out of video consultations in march , in response to the covid- emergency, cwtch cymru went into partnership with technology enabled care (tec; https://digitalhealth.wales/tec-cymru) and the welsh government to form a national video consultation service. this service is currently rapidly scaling up the routine use of video consultations across wales, using the attend anywhere communication platform, to all appropriate primary, secondary and community care services, including mental healthcare for all ages. the national video consultation service has a fully resourced website, with helpful guides, videos and toolkits, which can be accessed and used in addition to this paper. , video consultation experience and lessons learned the experience gained from working on two very different sized projects (small versus large scale) and in two very different contexts (normal versus pandemic) has demonstrated that regardless of the scale and rate of adoption, there are distinct challenges in introducing video consultations as a new way of working in the nhs for clinicians. clinician acceptance and use of video as an accepted alternative to established ways of working were found to be rate-limiting factors with respect to adoption and spread. this challenge is defined by the authors as 'clinician need versus clinical need'. this definition suggests that video consultations are more likely to be adopted and accepted as a feasible approach to healthcare delivery when the 'need' for this way of working is defined and accepted by the clinician or service, compared with when they are defined and accepted as a clinical need. in other words, video consultations are generally more successful and sustainable when a clinician or service perceives the need themselves and requests the service, rather when they are motivated by the projection of need or want from their patient population. it is therefore essential to establish and define this 'need' within a service, seeing clinician/service 'pull' for video consultation as an essential criterion for successful adoption. when the perceived need for video consultations by clinicians and services increased in the pandemic context, there was greater willingness to test new ways of working and overcome perceived or internal barriers to change. this has significant implications for how video consultations should be introduced into services and organisations, highlighting the need to focus on both the technical and the cultural aspects of the adoption process. these findings mirror the work of greenhalgh et al and their 'nasss' (non-adoption, abandonment and barriers to spread, scale-up and sustainability) framework. despite the increasingly widespread use of video consultations, there are very few visual and fully documented descriptions of how to set up and implement such consultations in real-time practice with specific attention to features such as fitting into existing systems and the legal and ethical requirements of video consultations. this step-by-step guide will describe the process based on two examples: a single health board project (delivered in normal time), and an all-wales national video consultation service roll-out (delivered during the covid- pandemic emergency). this paper was designed to be a simple and visual step-by-step guide describing how to set up and use video consultations for mental health services, including a range of 'technical' skills and knowledge that clinicians and services may find helpful for the adoption of video consultations. this paper will describe the various steps that have been taken by the authors in their real-time experience to initiate and implement a new video consultation programme in an existing nhs systems. the visuals used on the tec website and in this paper are adaptations and syntheses of work from other recent video consultation reports in the uk. [ ] [ ] [ ] note that the visual diagrams and infographics used in this paper are examples based on the communication platform attend anywhere (https://www.attendanywhere.com); therefore, descriptions and instructions may differ slightly depending on the type of platform used in your health service. ethical approval was obtained from all seven welsh research and development departments. consent was obtained from all participants in both cwtch and the national video consulting service. step-by-step guide this section of the paper will provide a step-by-step guide that is divided up into three distinct sections. the first section demonstrates how to set up video consultations in an existing healthcare workflow. the second section provides the appropriate steps regarding ethical and legal principles. the third section discusses how to use video consultations in a secondary care health service, with the help of an infographic diagram. within your healthcare service, you will need to identify a lead clinician who will decide how best to set up, use and manage the video consultations (fig. ) . this person will be the 'point of call' for your service and its use of video consultations. your healthcare service will need to define and agree on clinical criteria for video consultations and the suitability and appropriateness of appointment types. following this agreement, a template for triage or suitability would need to be developed and provided to the person(s) in charge of making video appointments, e.g. a receptionist. your service will need to identify how video consultations will be made, and who will make and deliver these appointments. your service will also need to identify how appointment links and information will be sent to patientsfor example, via a letter, verbally or via an sms text or emailand how appointment slots will be offered, documented and given to the delivering clinician. in addition, your service will need to decide how the video consultation will be managed, how clinical templates and coding will be used for video consultations, and how these will be matched to existing systems. your service will need to have a contingency plan for possible scenarios or problems (for both technical and clinical possibilities). finally, your service will need to consider how clinical information is later documented, for example, similarly to the hand-written notes used in usual practice. your health service will need to identify how video consultations will be set up. for example, you will need to think about factors such as the room layout, e.g. whether it is welllit and well-positioned, confidentiality issues and clinical appropriateness. more about this can be found in the following sections. your service will need to decide how to deal with providing additional information; for instance, if the picture definition obtained via a video consultation is not good enough to allow accurate visualisation and identification of skin lesions, your service needs to decide how to obtain this additional information. it is important that patients are able to receive patient information leaflets as they would in a standard consultation. your service needs to decide the best mechanism for communicating this information to them. for example, you could email them. your service would also need to consider additional plans for in-person contact, such as for collection of prescriptions. key considerations in the use of video consultations include legal and ethical issues, such as defining and documenting patient suitability and the role of the clinician, risk assessments and contingency planning, privacy, confidentiality, security and consent (fig. ) . appropriate strategies covering ethical issues will be necessary, such as taking informed consent and ensuring confidentiality and security while using technology, and procedures for conducting risk assessments. your healthcare service will need to define and agree to clinical criteria for video consultations and the suitability and appropriateness of appointment types. this defining and all types of mental health services using video consultations, regardless of their level of risk, should consider conducting risk assessments, and abide by safeguarding principles and ethical guidelines. to start thinking about the population your service will deliver a video consultation to, and the risk exposure that may arise, it is advised to conduct an initial 'process mapping' of your service. process mapping will help your team to define video consultations in the context of your service, understand you would need to think about the following. • would using video consultations instead of in-person care increase risk in any way? • if so, what are these risks, and can they be resolved? • is the risk of using video consultations greater than not seeing the patient at all? • would these risks be the same if the service was delivered in person? • what other types of risks might there besuch as the setting, environment and clinical outcome? on completion of process mapping and initial risk assessments, the next step would be to start thinking aboutand formally agreeing to and documentingclear and concise safeguarding contingency plans for your video consultation service. this would involve a 'what to do' plan in the event of an emergency or concern arising during a virtual appointment. it is advised to list a wide range of scenarios, ranging from low-to high-risk possibilities. make it as specific to your service as possible, to make potential scenarios relatable to your staff. when developing the contingency plan, think about who is best suited to develop it and who will be following it, and consider a wide range of opinions and possibilities. develop a list of all possible scenarios and all levels of risk exposure, and make them specific, applicable and relatable to your service. video consultations, like any other form of healthcare delivery, will need to be treated exactly the same way as in-person care with regards to ethical guidelines and procedures. however, owing to the obvious remoteness of a virtual appointment, there are additional ethical considerations which need to be considered and applied, such as confidentiality, privacy and security issues. it is essential that a video consultation service replicates an in-person appointment or assessment as much as possible. for example, the setting of an appointment room would ideally need to be the same as an in-person appointment room, e.g. if your service would normally use a private room for an in-person appointment, then a virtual appointment would also need this. it is also important to ensure that the platform used for video consultations is safe and secure, and that it meets your existing health systems standards, including software encryption. many popular video chat platforms such as facetime and whatsapp are not compliant with healthcare standards; therefore, you would need to seek out a safe and secure platform such as attend anywhere (https://www.attendanywhere.com). informed consent is the process of seeking agreement from a person before taking a course of action that requires consent. informed consent is required from any person who is receiving a video consultation. there are two types of consent. • implied consent (or tacit consent), which is signalled by the behaviour of an informed person in agreement. this type of consent is typically used in the delivery of 'in-person' healthcare. • explicit consent is when a person actively agrees, either verbally or in writing. this type of consent is highly recommended for video consultations, as signalled (implied) behaviour may be more difficult to capture remotely. to obtain consent, the person giving it would need to be considered to fully understand the process and to have full capacity to do so. a person with incapacity, such as a child or vulnerable adult, may not be able to give informed consent; therefore, parental or guardian consent (known as assent) would be required. the final step of this guide describes how to use video consultations in a secondary healthcare service (fig. ). as shown in the above figs and , your healthcare service will need to define and agree to clinical criteria and patient suitability for video consultations. this is considered the most important step for video consultations. depending on the type of communication platform (e.g. attend anywhere) you will be using, the patient will need to be offered the video appointment; they will then need to agree to it, after which they will need to be sent the patient information sheet and url link to access the video call. again, depending on the type of communication platform you will be using, there will need to be clear steps set out to determine how best to use video consultations in your service. to ensure that the use of video consultations is properly integrated into your health service, it is important to capture feedback on use, acceptability, suitability and satisfaction. it is therefore advisable to establish an evaluation framework to capture this. an example of this may include attaching a basic satisfaction survey to the end of the video consultation, asking a few 'how did it go' questions. for additional information, please see the tec website (https://digitalhealth.wales/tec-cymru), which provides a detailed step-by-step guide on setting up a video consultation (fig. ) , healthcare-specific toolkits, including examples of information sheets, suggested scripting for clinicians, technical guides to the attend anywhere communication platform and much more. this paper outlines a simple visual step-by-step guide to help clinicians to set up and use video consultations in mental health services. this resource has been used to support clinicians to gain the technical skills and knowledge required to routinely use video consultations in practice. in addition, we found that there is an important 'cultural' aspect to successful adoption of video consultations, where the ratelimiting factor for successful adoption is the 'need' and 'pull' for this way of working to be defined and accepted by the clinician or ser vice. when the perceived need for video consultations by clinicians and services increased in the pandemic context, there was greater willingness to test new ways of working and overcome perceived or internal barriers to change. it will be interesting to see whether having made the change to this new way working in the pandemic context, clinicians and services actively choose to maintain these newly gained technical skillsand also whether patients and carers, having experienced video consultations for the first time, increase their demand for this to become a new 'routine' way of working. as use of video consultations increases, we will also undoubtedly learn how to titrate this offer according to need, circumstance and demographics, and discover which healthcare treatments can best be deployed or augmented through the use of video consultations. this paper provides a guide to using video consultations in the nhs, based on personal experience of the authors and feedback from their evaluation. however, it is still early days for video consultations in wales, and more research is needed to understand more about their use, particularly what can and can't be done using video consultation, as this is still unspeculative and unproven. g.j. contributed to the main write up and development of the paper; she developed the manuscript draft, designed the template of the visual and infographics, and was involved in the overall structure and design, and in making amendments to the final manuscript. j.t. helped structure the manuscript and contributed clinical understanding to the guidelines, visuals and infographics. a.b. contributed some of the written text in the paper and wrote up the conclusion, and also helped structure the final manuscript and helped with amendments. m.o. contributed to the development, structure and reading of the manuscript (draft and final), and provided a technical and overall national programme perspective on the paper and its guidelines. c.r. redesigned the draft templates into the final graphics for this paper, including the four visuals and the infographic, and also contributed to the structure and reading of the manuscript. a.a. was responsible for overseeing the entire development of the paper, helped structure the manuscript (draft and final), developed and shaped the clinical and technical perspective on the clinical guidelines provided in the paper, and helped develop the visuals and infographic. the cwtch project was funded by the health foundation as a quality improvement project in aneurin bevan university health board in wales. the national video consultation programme is currently being funded by the welsh government to test video consultation across all of wales. none. icmje forms are in the supplementary material, available online at https:// doi.org/ . /bjb. . . telehealth and patient satisfaction: a systematic review and narrative analysis client acceptability and quality of life -telepsychiatry compared to in-person consultation the effectiveness of tele-mental health applications: a review effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial the effectiveness of telemental health: a review the empirical evidence for telemedicine interventions in mental disorders rural versus suburban primary care needs, utilization, and satisfaction with telepsychiatric consultation effects of telepsychiatry on the doctor-patient relationship: communication, satisfaction, & relevant issues child and adolescent telepsychiatry utilisation and satisfaction what about telepsychiatry? a systematic review the e-mental health consultation service: providing enhanced primary-care mental health services through telemedicine review of key telepsychiatry outcomes telepsychiatry assessments of child or adolescent behaviour disorders: a review of evidence and issues telepsychiatry in child and adolescent psychiatry. are patients comparable to those in usual outpatient care? a randomised controlled trial of child psychiatric assessments conducted using videoconferencing a retrospective analysis of child and adolescent emental health program can telepsychiatry replace in-person psychiatric assessments? a review and meta-analysis of comparison studies a randomized pilot trial comparing videoconference versus face-to-face delivery of behaviour therapy for childhood tic disorders telehealth and patient satisfaction: a systematic review and narrative analysis urban telepsychiatry: uncommon service for a common need benefits of a telepsychiatry consultation service for rural nursing home residents the health foundation. introducing telepsychiatry in child and adolescent mental health services. the health foundation the cwtch cymru toolkit, ready, set, go! royal college of psychiatrists in wales cwtch: connecting with telehealth to communities and hospitals in healthcare. rcpsych, video consulting toolkits. tec cymru, no date beyond adoption: a new framework for theorizing and evaluating nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability of health and care technologies medical sciences division. video consulting in the nhs. nuffield department of primary care health sciences video consultations: a guide in practice. bjgp life covid- : a remote assessment in primary care key: cord- -f aelem authors: cinquini, lino title: introduction to the special issue “service business innovation: implications on governance, management accounting and control” date: - - journal: j manag gov doi: . /s - - - sha: doc_id: cord_uid: f aelem nan lino cinquini © springer science+business media, llc, part of springer nature the relevance of service economy is well acknowledged if considering the share of the service sector in the world economy which has grown steadily from the ' in a trend that is continuing (schwab ) . such trend is furthermore pushed by the advent of digital technologies and, wider, by the fourth industrial revolution (frank et al. ) . within this process, the phenomenon of servitization in manufacturing firms has been recognized as the trend to "the increased offering of fuller market packages or 'bundles' of customer focussed combinations of goods, services, support, selfservice and knowledge in order to add value to core corporate offerings" (vandermerwe and rada ) . it represents a business model innovation where the relationships between products and services change in the logic of value creation (baines et al. ; lay ) . the recent covid- pandemic has further highlighted the relevance of service business models underlying their potential for improving resilience and driving innovation, fostering an increasing number of firms to undertake processes of digital servitization (rapaccini et al. ) . there are several critical aspects to be taken into consideration to support the service business innovation of the manufacturers. first, new governance is supposed to be flexible enough to deal with different levels of service innovation across the customer industries in different regions. this furthermore requires new management accounting practices (for instance financial indicators) for the manufacturers. second, regarding the financial aspects of the new service operations, the value is increasingly generated along the entire life-cycle of the products and their relations/connections to use contexts. third, the management accounting needs to be re-thought to fit with the organizational changes, to manage the product fleets, to increase customer value and to enhance service operations. in this respect, the choice of a servitization strategy naturally affects the division of tasks between the manufacturers, the customers and third-party service providers. it challenges the managerial systems of the company requiring a rethinking of management accounting in supporting the service business beyond the organizational boundaries. however, the majority of the companies are struggling in identifying and introducing the required governance and management accounting to support their service business innovation. new tools and concepts are crucial for releasing the service business potential and to manage the performance and profitability of the parties involved (tenucci and laine ) . despite their practical relevance, these aspects are among the topics which have not been sufficiently addressed in the literature (baines et al. ). the articles published in this special issue on "service business innovation: implications on governance, management accounting and control" were presented in a workshop debating these themes held at the scuola superiore sant'anna in . the submission and review process for the special issue led to the final selection of these three papers. the first paper by andrea tenucci and enrico supino titled "exploring the relationship between product-service system and profitability" focuses on productservice systems (pss) examining the relationship between pss categories and profitability. the paper is based on empirical analysis and uses a dataset of , companies on machinery manufacturing industry drawn from the orbis database. it shows that profitability could be represented by an ideal bell curve considering on the horizontal axis a spectrum of pss with an increasing servitization level, meaning that higher profitability is expected for the central pss categories (product-oriented, service-oriented and use-oriented pss). the second paper by antonio leotta, carmela rizza and daniela ruggeri titled "servitization strategy as a roadmap for the accounting machine" focuses on how the awareness of the servitization strategy among managers facilitates the use of accounting techniques aimed to support and realize such strategy. the paper reinterprets the metaphor of the accounting machine from the perspective of pragmatic constructivism and investigates how the accounting machine is used to prevent the servitization paradox. furthermore, using an interpretive case study, the authors highlight how the awareness of the servitization strategy helped managers in the use of accounting information throughout the new product development project's maturity stages, characterized by different degrees of uncertainty. the last paper by kati stormi, anni lindholm, teemu laine and tuomas korhonen titled "rfm customer analysis for product-oriented services and service business development: an interventionist case study of two machinery manufacturers" demonstrates the use of recency, frequency, and monetary value (rfm) analysis of service consumption to better segment product-oriented services customers and impacting the decision-making process. the paper applies an interventionist approach using two case studies of large original equipment manufacturers and contributes in the management accounting literature showing how the utilization of rfm tool requires rethinking of the elements of analyses traditionally used in decision-making. these contributions feed the debate on the phenomenon of servitization in manufacturing, which is deeply intertwined with digitalization and deserves consideration in contemporary research in management and governance. the servitization of manufacturing servitization and industry . convergence in the digital transformation of product firms: a business model innovation perspective servitization in industry navigating disruptive crises through service-led growth: the impact of covid- on italian manufacturing firms. industrial marketing management the global competitiveness report the role of management accounting in servitization servitization of business: adding value by adding services publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations where he is direct or of m.sc. in innovation management and member of the teaching board of the ph.d. in management. his research areas are management accounting, cost management, strategic management accounting and performance measurement in private and public sector. he has been co-editor of key: cord- - ome h authors: levinson, maxwell adam; niestroy, justin; manir, sadnan al; fairchild, karen; lake, douglas e.; moorman, j. randall; clark, timothy title: fairscape: a framework for fair and reproducible biomedical analytics date: - - journal: biorxiv doi: . / . . . sha: doc_id: cord_uid: ome h results of computational analyses require transparent disclosure of their supporting resources, while the analyses themselves often can be very large scale and involve multiple processing steps separated in time. evidence for the correctness of any analysis consists of accessible data and software with runtime parameters, environment, and personnel involved. evidence graphs - a derivation of argumentation frameworks adapted to biological science - can provide this disclosure as machine-readable metadata resolvable from persistent identifiers for computationally generated graphs, images, or tables, that can be archived and cited in a publication including a persistent id. we have built a cloud-based, computational research commons for predictive analytics on biomedical time series datasets with hundreds of algorithms and thousands of computations using a reusable computational framework we call fairscape. fairscape computes a complete chain of evidence on every result, including software, computations, and datasets. an ontology for evidence graphs, evi (https://w id.org/evi), supports inferential reasoning over the evidence. fairscape can run nested or disjoint workflows and preserves the provenance graph across them. it can run apache spark jobs, scripts, workflows, or user-supplied containers. all objects are assigned persistent ids, including software. all results are annotated with fair metadata using the evidence graph model for access, validation, reproducibility, and re-use of archived data and software. fairscape is a reusable computational framework, enabling simplified access to modern scalable cloud-based components. it fully implements the fair data principles and extends them to provide fair evidence, including provenance of datasets, software and computations, as metadata for all computed results. computation is an integral part of the preparation and content of modern biomedical scientific publications, and the findings they report. computations can range in scale from simple statistical routines run in excel spreadsheets to massive orchestrations of very large primary datasets, computational workflows, software, cloud environments, and services. they typically produce data and generate images as output. scientific claims of the authors are supported both by reference to the existing domain literature, and to the experimental or observational data and its analysis represented in the figure or image. the ideal recommended practice is now to archive and cite one's own experimental data (cousijn et al. ; data citation synthesis group ; fenner et al. ; groth et al. ) ; to make it fair (wilkinson et al. ) ; and to archive and cite software used in analysis (smith et al. ) . that is, increasingly strict requirements are demanded to leave a digital footprint of each preparation and analysis step in derivation of a finding to support reproducibility and reuse of both data and tools. this is a welcome development, now extended by many journals into the realm of critical research reagents (a. bandrowski ; a. e. bandrowski and martone ; prager et al. ) . how do we facilitate it? and how do we make the recorded digital footprints most useful? our notion, inspired by a large body of work in abstract argumentation frameworks, and analysis of biomedical publications (tim clark et al. ; greenberg greenberg , , is that the evidence for correctness of any finding can be represented as a directed acyclic support graph, an evidence graph. when combined with a graph of challenges to statements, or their evidence, this becomes a bipolar argument graph -or argumentation system (cayrol and lagasquie-schiex . we have abstracted core elements of our micropublications model (clark et al. ) to create evi (http://w id.org/evi), an ontology of evidence relationships that extends the w c provenance ontology, prov (gil et al. ; lebo et al. ; moreau et al. ) , to support specific evidence types found in biomedical publications, reasoning across deep evidence graphs, and propagation of evidence challenges deep in the graph, such as: retractions, reagent contamination, errors detected in algorithms, disputed validity of methods, challenges to validity of animal models, and others. (al manir & clark, in preparation; w id .org/evi#). evi is based on the fundamental idea that scientific findings or claims are not facts, but assertions backed by some level of evidence, i.e., they are defeasible components of argumentation. therefore, evi focuses on the structure of evidence chains that support or challenge a result, and on providing access to the resources identified in those chains. evidence in a scientific article is in essence, a record of the provenance of the finding, result, or claim asserted as likely to be true. if the data and software used in analysis are all registered and receive persistent identifiers (pids) with appropriate metadata, a provenance-aware computational data lake, i.e., a data lake with provenance-tracking computational services, can be built that attaches evidence graphs to the output of each process. at some point, a citable object -a dataset, image, figure, or table will be produced as part of the research. if this, too, is archived with its evidence graph as part of the metadata and the final supporting object is either directly cited in the text, or in a figure caption, then the complete evidence graph may be retrieved as a validation of the object's derivation and as a set of uris resolvable to reusable versions of the toolsets and data. evidence graphs are themselves entities that can be consumed and extended at each transformation or computation. a cogent use case for this treatment of evidence comes from the recent surgisphere retractions in covid- research mehra, mandeep r et al. ) , and earlier, the obokata "stimulus transitioned acquisition of pluripotency" (stap) retractions (aizawa ; ishii et al. ; haruko obokata, wakayama, et al. ) . many more such cases could be cited, including the wakefield paper in lancert which claimed that mmr vaccination caused autism (deer ; the editors of the lancet ; wakefield et al. ). in these well-publicized cases, research that initially appeared to have groundbreaking promise, was shown to be invalid based on examination of the underlying data and methods. while the obokata and surgisphere retractions occurred relatively quickly, due no doubt to the egregiousness of the scientific misconduct involved, it is reasonable to believe that less obtrusive, or more well-concealed errors, malfeasance, or simple hyped-up claims with a poor (or no) basis in evidence, is much more prevalent. we set out to construct a provenance-aware computational data lake, as described above, by significantly extending and refactoring the identifier and metadata services framework we and our colleagues developed in the nih data commons pilot project consortium (timothy clark et al. ; fenner et al. ). this framework successfully demonstrated interoperability across several nih "data commons" environments, providing the identifier, authn/authz, and metadata management elements of grossman's "data ecosystem" concept (grossman ) . we extended and re-engineered this framework over time to track and visualize computations and their evidence, to manage the computational objects (such as data and software) as well as their metadata, to analyze very large datasets with horizontal scale-out, to support neuroimaging workflows, and to make it generally more easy for scientists and computational analysts to use, by providing binder and notebook services (jupyter et al. ; kluyver et al. ) , and a python client. end-users do not need to learn a new programming language to use services provided by fairscape. they require no additional special expertise, other than basic familiarity with python and the skillsets they already possess in statistics, computational biology, machine learning, or other data science techniques. fairscape provides an environment that makes large-scale computational work easier and results fairer. fairscape is a reusable framework, suitable for installation in private, public, or hybrid cloud environments. we have also installed it on a high-end laptop. it focuses on ease of use for computational researchers, while capturing an extensible record of provenance, transparently to the user. fairscape provenance is rendered as named evidence graphs. these provide a complete record of any series of computations, with fair access to every digital object in a series of computations and transformations, whether or not connected in a workflow, or done by different users, including both datasets and software source code. the remainder of this article describes the approach, microservices architecture, and interaction model of the fairscape framework in detail. fairscape is built on a multi-layer set of components using a containerized microservice architecture (msa) (balalaie et al. ; larrucea et al. ; lewis and fowler ; wan et al. ) running under kubernetes (burns et al. ) in an openstack (adkins ) private cloud environment, with a devops deployment model (balalaie et al. ; leite et al. ). an architectural sketch of this model is shown in figure . ingress to microservices in the various layers is through a reverse proxy using an api gateway pattern. the top layer provides an interface to the end users with raw data and the associated metadata. the mid layer is a collection of tightly coupled services that allow end users with proper authorization to submit and view their data, metadata, and various types of computations performed on them. the bottom layer is built with special purpose storage and analytics platforms for storing and analyzing data, metadata and provenance information. all objects are assigned pids using local ark assignment for speed, with global resolution for generality. the user interface layer in fairscape offers end users various ways to utilize the functionalities in the framework. a reproducible interactive executable environment using binders offers users with proper authorization the ability to use the features with ease. a python client simplifies calls to the microservices. data, metadata, software, scripts, workflows, containers, etc. are all are submitted and registered by the end users from the ui layer. access to the fairscape environment is through an api gateway, mediated by a reverse proxy. our gateway is mediated by traefik, which dispatches calls to the various microservices endpoints. accessing the services requires user authentication, which we implement using the globus auth authentication broker (tuecke et al. ). users of globusauth may be authenticated via a number of permitted authentication services, and are issued a token which serves as an identity credential. in our current installation we require use of the commonshare authenticator, with site-specific two-factor authentication necessary to obtain an identify token. this token is then used by the microservices to determine a user's permission to access various functionality. the microservices layer is composed of seven services and two interfaces: authentication, authorization, transfer, metadata, evidence, computation, search, and visualization services; and the object and cluster compute apis to lower level services. fairscape currently uses minio for object storage, mongodb for basic metadata storage, and stardog for graph storage. computations are managed by kubernetes, apache spark, and the nipype neuroinformatics workflow engine. this service transfers and registers digital research objects -datasets, software, etc., -and their associated metadata, to the commons. these objects are sent to the transfer service as binary data streams, which are then stored in minio object storage. these objects may include structured or unstructured data, application software, workflow, scripts. the associated metadata contains essential descriptive information such as context, type, name, textual description, author, location, checksum, etc. about these objects. metadata are expressed as json-ld and sent to the metadata service for further processing. hashing is used to verify correct transmission of the object -users are required to specify a hash which is then recomputed by minio after the object is stored. hash computation is currently based on the sha- secure cryptographic hash algorithm (dang ) . upon successful execution, the service returns a pid of the object in the form of an ark, which resolves to the metadata. the metadata includes, as is normal in pid architecture, a link to the actual data location. an openapi description of the interface is here: https://app.swaggerhub.com/apis/fairscape/transfer/ . the metadata service handles metadata registration and resolution including identifier minting in association with the object metadata. the metadata service takes user posted json-ld metadata and uploads the metadata to mongodb and stardog, and returns a pid. to retrieve metadata for an existing pid a user makes a get call to the service. a put call to the service will update an existing pid with new metadata. while other services may read from mongodb and stardog directly, the metadata service handles all writes to mongodb and stardog. an openapi description of the interface is here: https://app.swaggerhub.com/apis/fairscape/metadata-service/ . this service executes user uploaded scripts, workflows, or containers, on uploaded data. it currently offers two compute engines (spark, nipype) in addition to native kubernetes container execution, to meet a variety of computational needs. to complete jobs the service spawns specialized pods on kubernetes designed to perform domain specific computations that can be scaled to the size of the cluster. this service provides the essential ability to recreate computations based solely on identifiers. for data to be computed on it must first be uploaded via the transfer service and be issued an associated pid. the service accepts a pid for a dataset, a script, software, or a container, as input and produces a pid representing the activity to be completed. the request, if successful, returns a job identifier from which job progress can be followed. upon completion of a job all outputs are automatically uploaded and assigned new pids, with provenance aware metadata. at job termination, the service performs a 'cleanup' operation, where a job is removed from the queue once it is completed. an openapi description of the interface is here: https://app.swaggerhub.com/apis/fairscape/compute/ . this service allows users to visualize evidence graphs interactively in the form of nodes and directed edges, offering a consolidated view of the entities and the activities supporting correctness of the computed result. our current visualization engine is cytoscape (shannon ) . each node displays its relevant metadata information, including its type and pid, resolved in real-time. the visualization service renders the graph on an html page. an openapi description of the interface is here: https://app.swaggerhub.com/apis/fairscape/visualization/ . the evidence graph service creates a json-ld evidence graph of all provenance related metadata to a pid of interest. the evidence graph documents all entities such as datasets, software, and workflows, and the activities performed involving these entities. the service accepts a pid as its input, runs a specialized path query built on top of the sparql query engine in stardog with the pid as its source to retrieve all supporting nodes that can be reached. to retrieve an evidence graph for a pid a user may make a get call to the service. an openapi description of the interface is here: https://app.swaggerhub.com/apis/fairscape/evidence-graph/ . the search service allows users to search for object metadata containing strings of interest. it accepts a string as input and performs a search over all literals in the metadata for exact string matches and returns a list of all pids with a literal containing the query string. it is invoked via the get method of api endpoint to the service with the search string as argrument. an openapi description of the interface is here: https://app.swaggerhub.com/apis/fairscape/search/ . fairscape orchestrates a set of containers to provide the services in these layers, using kubernetes. the services support a pattern composed of the following steps: (a) api ingress, (b) user authentication and authorization, (c) service dispatch, (d) object acquisition, (e) computation, (f) object resolution and access. these steps rely on further components (g) identifier minting and resolution, (h) object access, (i) object verification, and (j) evidence graph visualization. the authn/authz service authenticates users and issues them a token, which is then used at the service level to determine what permissions they have in that service. metadata access is authorized separately from data access, and separately from service execution. a user may be authorized to read an object's metadata, but not its data. this is accomplished by preventing return of the downloadurl term by the metadata service, and as a second level assurance, by blocking access to the object's s bucket in minio. the transfer service provides import of an object -software, container, or dataset -into fairscape, documenting its origin, and enabling descriptive metadata to be attached. once the object is stored robustly, it can be computed upon. objects are automatically registered with a persistent identifier (pid) upon acquisition. these are currently limited to archival resource keys (arks), generated locally. we plan to enable datacite doi registration shortly. this was an original feature of the object registration system we developed in the nih data commons pilot, however since that time, changes have been made to the datacite api which we need to review and address in our code. the compute service executes computations using either a container specified by the user, or the apache spark service, or the nipype workflow engine. objects (again, datasets, software, containers) are passed to the compute service by their pid, retrieved from the object store, and acted upon using the facilities indicated. at end, the result is written back to the object store, the metadata store is updated, and the evidence graph updates the support graph. for nipype jobs, the metadata includes all prov records for each step of the workflow. for spark jobs, data from the object store is written to the hfs file system, which maintains a direct interface with minio, separate from and below the level of the compute service, for efficiency. the metadata service mints pids using the appropriate internal or external service. in the current deployment, that is local ark minting with global resolution. multiple alternative pids may exist for any object, and doi registration is a planned near-term feature. pids are resolved to their associated object level metadata, including the object's evidence graph and location, with appropriate permissions. objects are accessed by their location, after prior resolution of the object's pid to its metadata and authorization of the user's authentication token for data access on that object. object access is either directly from the object store, or from wherever else the object may reside. certain large objects residing in robust external archives, may not be acquired into local object storage, but remain in place, up to the point of computation. objects are issued hashes when they are created, and these hashes are also required metadata on ingress. the original user-supplied hashes are verified whenever an object is ingested, and internally computed hashes are provided for re-verification when the object is accessed. evidence graphs of any object acquired by the system may be visualized at any point in this workflow using the visualization service. nipype provides a chart of the workflows it executes using the graphviz package. our evidence graph service is interactive, using the cytoscape package (shannon ) , and allows evidence graphs of multiple workflows in sequence to be displayed whether or not they have been combined into a single flow. service testing and deployment is automated following modern continuous integration / continuous deployment (ci/cd) devops practices. when code is committed to the github repository, unit and integration tests are automatically invoked. if the tests are passed, automated deployment of the microservice containers is invoked using jenkins pipelines (soni ) and helm charts. this allows for rapid evolution of the platform with reasonable integrity. we have installed fairscape both in a large private cloud cluster computing environment at our university, and on laptops. we used fairscape services to analyze ten years of neonatal icu vital signs data from over , babies with over different highly comparative time series analysis (hctsa) methods taken from the literature (fulcher et al. ; fulcher and jones ) , recoding many of them from matlab into python. we analyzed the data with operations computed using several parameter sets amounting to > , separate computations (niestroy et al., in preparation) . one key step in the analysis was to cluster the algorithms by the similarity of the results. the results were represented in the heat map shown in figure . the evidence graph for this result is quite large. a visualization of a section for one patient is shown in figure . the full evidence graph for the clustering computation has , nodes. the json-ld for this individual patient example is shown in figure . metadata for the archived image includes the json-ld evidence graph. in this set of computations, all steps required authentication and authorization within the university of virginia computing infrastructure. we then used the following service calls to do the analysis: (a) transfer service to register all the objects with metadata and pids; (b) compute service to perform the individual computations, using apache spark; (c) evidence graph service to compute and retrieve the evidence graph and create the visualization. internally, services call each other in a more complex way, but this is masked from the user. for example, transfer service calls the metadata service to mint identifiers and register metadata, and it performs object verification against the inbound sha hash. we ran neuroimaging workflows using test data provided for the nipype workflow engine (gorgolewski et al. ) . metadata for the archived computational result includes this evidence graph. a visualization of the evidence graph is shown in figure . intermediate results for such workflows have time-limited utility. per data citation guidelines (data citation synthesis group ; fenner et al. ; starr et al. ) , it is acceptable to clear this data if the useful metadata describing the procedure is preserved, which we do here. the service calls to perform this work were similar to those in use case above, with the exception that the compute service was called using the nipype option. scientific rigor depends on the transparency of methods and materials. the historian of science steven shapin, described the approach developed with the first scientific journals as "virtual witnessing" (shapin ) , and this is still valid today. the typical scientific reader does not actually reproduce the experiment but is invited to review mentally every detail of how it was done to the extent that s/he becomes a "virtual witness" to an envisioned live demonstration. that is clearly how most people read scientific papers -except perhaps when they are citing them, in which case less care is often taken. scientists are not really incentivized to replicate experiments; their discipline rewards novelty. the ultimate validation of any claim once it has been accepted as reasonable on its face comes with support from multiple distinct angles, by different investigators, and with re-use of the materials and methods upon which it is based. if the materials and methods are sufficiently transparent and thoroughly disclosed as to be reusable, and they cannot be made to work, or give bad results, that debunks the original experiments -precisely the way in which the promising-sounding stap phenomenon was discredited (haruko , before the elaborate formal effort of riken to replicate the experiments. as a first step then, it is not only a matter of reproducing experiments but also of producing transparent evidence that the experiments have been done correctly. this permits challenges to the procedures to develop over time, especially through re-use of materials (including data) and methods -which today significantly include software and computing environments. we definitely view these methods as being extensible to materials such as reagents, using the rrid approach (prager et al. ) . fairscape is a reusable framework for biomedical computations that provides a simplified interface for research users to an array of modern, dynamically scalable, cloud-based componentry. our goal in developing fairscape was to provide an ease-of-use (and re-use) incentive for researchers, while rendering all the artifacts marshalled to produce a result, and the evidence supporting them, findable, accessible, interoperable, and reusable. fairscape can be used to construct, as we have done, a provenance-aware computational data lake or commons. it supports transparent disclosure of the evidence graphs of computed results, with access to the persistent identifiers of the cited data or software, and to their stored metadata. we plan several enhancements in future research and development with this project, including support for doi and software heritage identifier registration, metadata transfer to dataverse instances, and integration of the galaxy workflow engine for genomic analysis, for release later this year. many efforts involving overlapping groups have attempted to address parts of this problem, which is in large part an outcome of the transition of biomedical and other scientific research from print to digital, and our increasing ability to generate data and to compute on it at enormous scale. we make use of many of these in our fairscape framework, providing an integrated model for fairness and reproducibility, with ease of use openstack: cloud application development results of an attempt to reproduce the stap phenomenon microservices architecture enables devops: migration to a cloud-native architecture rrid's are in the wild! thanks to jcn and peerj. the nif blog: neuroscience information framework rrids: a simple step toward improving reproducibility through rigor and transparency of experimental methods bipolar abstract argumentation systems coalitions of arguments: a tool for handling bipolar argumentation frameworks bipolarity in argumentation graphs: towards a better understanding micropublications: a semantic model for claims, evidence, arguments and annotations in biomedical communications national institutes of health, data commons pilot phase consortium a data citation roadmap for scientific publishers. scientific data secure hash standard (no. nist fips - ) (p. nist fips - ). national institute of standards and technology joint declaration of data citation principles how the case against the mmr vaccine was fixed tracking the growth of the pid graph core metadata for guids. national institutes of health, data commons pilot phase consortium a data citation roadmap for scholarly data repositories hctsa : a computational framework for automated time-series phenotyping using massive feature extraction highly comparative time-series analysis: the empirical structure of time series and their methods prov model primer: w c working group note nipype: a flexible, lightweight and extensible neuroimaging data processing framework how citation distortions create unfounded authority: analysis of a citation network understanding belief using citation networks progress toward cancer data ecosystems data lakes, clouds, and commons: a review of platforms for analyzing and sharing genomic data fair data reuse -the path through data citation report on stap cell research paper investigation the nci genomic data commons as an engine for precision medicine binder . -reproducible, interactive, sharable environments for science at scale jupyter notebooks-a publishing format for reproducible computational workflows microservices. ieee software prov-o: the prov ontology w c recommendation a survey of devops concepts and challenges microservices: a definition of this new architectural term retraction: cardiovascular disease, drug therapy, and mortality in covid- retraction-hydroxychloroquine or chloroquine with or without a macrolide for treatment of covid- : a multinational registry analysis prov-dm: the prov data model: w c recommendation bidirectional developmental potential in reprogrammed cells with acquired pluripotency retraction note: bidirectional developmental potential in reprogrammed cells with acquired pluripotency stimulustriggered fate conversion of somatic cells into pluripotency improving transparency and scientific rigor in academic publishing cytoscape: a software environment for integrated models of biomolecular interaction networks pump and circumstance: robert boyle's literary technology software citation principles jenkins essentials: continuous integration, setting up the stage for a devops culture achieving human and machine accessibility of cited data in scholarly publications retraction-ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children globus auth: a research identity and access management platform retracted: ileallymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children application deployment using microservice and docker containers: framework and optimization the fair guiding principles for scientific data management and stewardship information sharing statement all code developed for this framework is provide a link to the creative commons license, and indicate if changes were made. the images or other third-party material in this article are included in the article's creative commons license, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder we thank satra ghosh, maryann martone, john kunze, neal magee, and chris baker, for several helpful discussions; and neal magee for technical assistance with the university of virginia computing infrastructure. this work was supported in part by the u.s. national institutes of health, grants nih ot od - and nih u hg ; and by a grant from the coulter foundation. maxwell adam levinson, orcid: - - - sadnan al manir, orcid: - - - key: cord- -xnuta p authors: kibria, md. golam; islam, taslima; miah, md. shamim; ahmed, shakil; hossain, ahmed title: barriers to healthcare services for persons with disabilities in bangladesh amid the covid- pandemic date: - - journal: nan doi: . /j.puhip. . sha: doc_id: cord_uid: xnuta p nan disability is a major public health issue in bangladesh where about . % of the total population lives with some form of disabilities. in villages and small towns hardly avail follow-up and emergency services amid the covid- pandemic as they cannot visit tertiary and specialized hospitals in big towns and cities due to the shutdown. this non-availability of emergency services heightens their risk of complications and even death. many government and private hospitals turned away patients with fever and flu amid the pandemic, suspecting them covid- positive. on the same ground, those pwds having fever and flu may be rejected by the hospitals regardless they really suffer from common illnesses like fever, flu and diarrhea or chronic diseases such as stroke, heart disease, chronic obstructive pulmonary disease (copd) and diabetes. this may lead them to experience serious complications of comorbid conditions. furthermore, many pwds cannot pass a single day without the assistance of a caregiver. this assistance involves close physical contact. some caregivers who are not family members of pwds may leave their job amid the pandemic for fear of coronavirus infection. caregivers are usually trained on therapeutic exercises, activities of daily living and use of assistive devices. they cannot perform therapeutic exercises, activities of daily living and use assistive devices in the absence of caregivers, which are an important part of their regular healthcare. as in bangladesh, disability rate is high in other lmics, and pwds from those countries have scarce access to emergency healthcare services amid the covid- pandemic. evidence shows that medical treatment, rehabilitation and support services have been disruptive to pwds in many other countries, including india, nepal, iran and mali during the pandemic , , , considering the emergency healthcare needs of this group, effective measures should be adopted to enhance service accessibility in the time of this virus pandemic. emergency transport services with special stickers should be made available at all times for pwds to receive emergency services from tertiary and specialized hospitals in big towns and cities. in every hospital, there should be a disability unit with doctors, nurses, physiotherapists, occupational therapists, speech & language therapists, prosthetists, orthotists and other related associates. government emergency telemedicine programmes should also have a special line for dealing with the health problems of pwds. moreover, there should be a substitute caregiver from the pwd's family, who will be trained on caregiving in the absence of professional caregivers. report of the household income and expenditure survey convention on the rights of persons with disabilities. vienna: united nations public transport shutdown extended till may . unb news the organization and financing of health services for persons with disabilities patients suffer as hospitals limit services. the new age disability in the time of covid- persons with disabilities grapple with more challenges pain and plight of people with disabilities during covid- pandemic: reflections from nepal covid- and disabled people: perspectives from iran how have people with disabilities been affected by the covid- pandemic? funding: the authors did not receive any fund for this paper. competing interest: the authors declared that they did not have any competing interest.ethical approval: not required. ethical approval was not taken because the article was written on secondary data. key: cord- -galaf wr authors: henkens, bieke; verleye, katrien; larivière, bart title: the smarter, the better?! customer well-being, engagement, and perceptions in smart service systems date: - - journal: nan doi: . /j.ijresmar. . . sha: doc_id: cord_uid: galaf wr smart service systems – that is, configurations of smart products and service providers that deliver smart services – are striving to increase the smartness of their offering, but potential consequences for customer well-being are largely overlooked. therefore, this research investigates the impact of smartness on customer well-being (here, self-efficacy and technology anxiety) through ( ) customer engagement with different smart service system actors (here, smart products and service providers) and ( ) customer perceptions (here, personalization and intrusiveness perceptions) and their associated importance (here, need for personalization and intrusiveness sensitivity). a scenario-based experiment (n = ) – which is preceded by a systematic review to conceptualize smartness – shows that customers perceive more personalization than intrusiveness in case of higher levels of smartness, resulting in customer engagement with the smart product and to some extent with the service provider. via customer engagement with the smart product, higher levels of smartness stimulate self-efficacy, especially for customers with a high need for personalization. when customers’ need for personalization is high and their intrusiveness sensitivity is low, higher levels of smartness also reduce technology anxiety via customer engagement with the smart product. hence, the conclusion is: “the smarter, the better!”, whereby the relationship between smartness and well-being (here, self-efficacy and technological anxiety) is significantly influenced by customer heterogeneity. these findings help business practitioners in boosting customer well-being by increasing customer engagement through higher levels of smartness of their service system. the household penetration of smart products like smart home devices is expected to increase to nearly billion units worldwide by (statista, ) . in this context, companies develop smart servicesthat is, services enabled by smart productsat an ever-faster pace (langley et al., ; mckinsey & company, ) . lg, for instance, evolved from their initial internet digital dios (i.e., a simple smart refrigerator that can show the items in the fridge by means of a camera and that can connect to the internet which allows customers to search for recipes or weather forecasts) to their latest instaview thinq fridge (i.e., a smart refrigerator that recognizes the grocery items inside and based on this information suggests recipes and options for reordering items at a connected grocery store). as illustrated by this example, lg continuously increases the smartness of its offerings, by which smartness reflects the extent to which smart services (e.g., keeping inventories and ordering groceries) are enabled through smart products (e.g., smart fridge). in a world where the smartness of offerings increases at a drastic rate, there is growing attention for customer well-being among researchers (e.g., anderson et al., ; ostrom, parasuraman, bowen, patrício, & voss, ; volkmer & lermer, ) and policymakers (e.g., broadband commission, ; european commission, ; european commission, next, this research contributes to the customer well-being literature as it unravels the smartness-well-being relationship by exploring the mediating role of customer engagement. indeed, studying the engagement-well-being responds to recent calls for research on the relationship between technology-facilitated engagement and customer well-being (hollebeek & belk, ) . more particularly, this inquiry reveals how customer engagement influences customer well-being with its eudaimonic facet (i.e., extent of self-realization; here, selfefficacy) and its hedonic facet (i.e., extent of pleasure; here, technological anxiety). as such, this research provides an extensive understanding of the engagement-well-being relationship and hence advances the literature on customer well-being. finally, this research contributes to the customer engagement literature by investigatingin line with calls for research on engagement in complex systems (alexander et al., ; brodie, fehrer, jaakkola, & conduit, ; zeithaml et al., )how customers engage with different actors in service systems with various levels of smartness. although smart service systems consist of smart products and service providers with whom customers can engage (beverungen et al., ; schweitzer, belk, jordan, & ortner, ) , (empirical) insights into the relationship between the level of smartness of service systems and customer engagement with the smart product and service providers are indeed lacking. in response to this gap, the present research explores the mechanisms through which smartness affects customer engagement with different smart service systems actors (here, personalization and intrusiveness perceptions along with their associated importance). as such, this research shows whether higher levels of smartness affect different actors in smart service systems in various ways. from a managerial perspective, practitioners in smart service systems gain insight into what smartness entails (i.e., smartness characteristics) and how to design their service system in terms of its level of smartness, so that customer engagement and customer well-being are improved. the subsequent section discusses our conceptual framework and hypotheses. next, we describe the exploratory study and the main study. we close by discussing the findings, the theoretical and managerial implications, as well as the limitations and future research avenues. the first section elaborates on the characteristics of smart service systems, thereby proposing smartness as a key differentiator in the smart service market. the subsequent section presents hypotheses about the relationship between smartness and customer engagement with smart service system actors, thereby taking personalization and intrusiveness mechanisms into account. the final section proposes hypotheses about the engagement-well-being relationship. smart service systems are configurations of smart products and service providers that deliver smart services (beverungen et al., ) . indeed, smart services are services enabled by smart products, which refer to objects that display both physical components (i.e., mechanical and engaged in a systematic literature review with an inductive analysis of definitions and/or descriptions of smart products, smart services, and smart systems in papers in the marketing, management, and computer literature. across all definitions and descriptions, we identified four smartness characteristics: awareness, connectivity, actuation, and dynamism (see table for descriptions and key quotes derived from our inductive analysis). as shown in the last column of table , each of these characteristics is essential and thus needs to be present for service systems to be smart. the next paragraphs detail each of these characteristics. ====================== insert table about here ====================== a first characteristic of smartness is awareness, which refers to the ability to sense information related to the smart service system and/or its surroundings (hsu & lin, ; töytäri et al., ; wünderlich et al., ) . this information is captured through sensors embedded in the smart service system (mani & chouk, ; rijsdijk & hultink, ). volvo"s smart car service, for instance, can sense data about itself (e.g., parts that need maintenance, its location) and its surroundings (e.g., bumps in the road, weather conditions). a second characteristic of smartness is connectivity, which encompasses the ability to connectthrough the internet of things (iot)different actors in the smart service system, namely customers, smart products, and service providers (atzori, iera, & morabito, ; fischer et al., ; kannan & li, ; ng & wakenshaw, ; verhoef et al., ) . for example, a smart digital assistant such as echo is able to link with numerous smart products (e.g., smart thermostat, smart watch) and service providers (e.g., grocery stores, retailers). a third characteristic of smartness is actuation, which is the ability to decide and act independently based on computational processes verhoef et al., ) . computation refers to the analysis and processing of the data collected through the j o u r n a l p r e -p r o o f smart service system"s sensors. these computational processes enable smart service systems to make decisions and act without customer intervention (lim & maglio, ; . based upon these processes, a smart service like gardena"s smart water control set is able to decide when plants need water and to water plants without customer intervention. finally, smartness is characterized by dynamism, which refers to the ability to learn and adapt based upon the relational and cyclical nature of smart service systems (beverungen et al., ; dreyer, olovotti, lebek, & breitner, ; kabadayi et al., ) . this nature is reflected by ongoing interactions among actors in the smart service system, thereby enabling smart products and service providers to learn customer preferences and to adapt their smart services over time (mani & chouk, ; . for example, smart thermostats (e.g., ecobee ) learn customers" preferred room temperature based upon multiple interactions, thereby enabling the adaptation of the temperature depending on the customer(s) present in the room. based upon these four characteristics of smart service systems that are inherently linked to one another (see table ), different levels of smartness emerge. in fact, the smartness of service systems can vary from low (low levels of awareness, connectivity, actuation, and dynamism) to high (high levels of awareness, connectivity, actuation, and dynamism). as many product and service providers are increasing the smartness of their offerings (beverungen et al., ; chouk & mani, ; langley et al., ) , we examine smartness as a key differentiator in the smart service market with implications for customer well-being through customer engagement. this section develops hypotheses about the relationship between smartness and customer engagement with the smart product and the service provider in the smart service system. to j o u r n a l p r e -p r o o f examine the smartness-engagement relationship, we propose two important underlying mechanisms: personalization mechanisms and intrusiveness mechanisms. these mechanisms reflect complex interactions between customer perceptions (perceived personalization and perceived intrusiveness) and their corresponding importance (respectively, customers" need for personalization and intrusiveness sensitivity) (see figure ). below, we first describe customer engagement in the context of smart service systems. next, we explain the smartness-engagement relationship and its underlying mechanisms. subsequently, we elaborate on customer well-being in smart service system contexts and substantiate the relationship between customer engagement and customer well-being. figure visually depicts these relationships. insert figure about here ====================== customer engagement has been conceptualized by some authors as a psychological or motivational state, which reflects the customer"s cognitive and emotional processing based on interactive experiences with a brand or firm (bowden, ; brodie, hollebeek, juric, & ilić, ) . other researchers centered on the behavioral manifestations of customer engagement, which relate to more observable actions such as word-of-mouth and helping other customers or employees (roy, shekhar, lassar, & chen, a; rutz, aravindakshan, & rubel, ; van doorn et al., ; verleye, gemmel, & rangarajan, ) . synthesizing these two perspectives, an increasing number of researchers have adopted a transcending perspective (e.g., brodie, ilic, juric, & hollebeek, ; pansari & kumar, ) . adopting this transcending perspective, we consider customer engagement as a psychological or motivational state with cognitive, affective, and behavioral manifestations. hence, customer engagement is a multidimensional concept (harrigan, evers, miles, & daly, ; hollebeek j o u r n a l p r e -p r o o f journal pre-proof et al., ) . building upon this conceptualization, the cognitive dimension refers to a customer"s mental processing related to interactions with a particular firm or brand. the affective dimension describes the degree of emotions a customer experiences towards the firm or brand. the behavioral dimension is defined as the customer"s amount of energy, time, and effort allocated to interactions with the firm or brand (hollebeek et al., ) . it has been widely recognized that customer engagement can go beyond dyadic interactions with a brand or firm (alexander et al., ) . indeed, customers often have multiple actors to whom their engagement can be directed (brodie, et al., ; jaakkola & alexander, ; roy et al., a; verleye et al., ) . this multi-actor engagement situation is inherent to the context of smart service systems (barile & polese, ; , by which smart service systems refer to the configuration of smart products and service providers that are responsible for delivering smart services (beverungen et al., ) . indeed, smart products may act as engagement objects for customers, as they enable the delivery of smart services (anke, ; beverungen et al., ; fischer et al., ; porter & heppelmann, ) . many consumers, for instance, cannot live without their smartphone, as these devices give immediate access to contacts while also facilitating daily activities like shopping (horwood & anglim, ; nie, wang, & lei, ) . as a result, customers build relationships with these smart products schweitzer et al., ) . in a similar vein, customers can engage with service providers whose services are enabled by smart products (allmendinger & lombreglia, ; wünderlich, wangenheim, & bitner, ; wünderlich et al., ) . social media companies, for instance, can elicit engagement by allowing customers to connect with one another and the same is true for retailers offering checkout-free shopping and other services via an app (david et al., ; fan, ning, & deng, ) . j o u r n a l p r e -p r o o f as illustrated by these examples, customers can engage with both smart products and service providers in the smart service system. the next paragraphs detail how personalization mechanisms and intrusiveness mechanisms explain the relationship between smartness and customer engagement with the smart product and the service provider. drawing from social exchange theory (blau, ) , several researchers argue that customers show engagement when brands or firms demonstrate investments beyond their mere economic obligations (cropanzano & mitchell, ; hollebeek, ; marchand, paul, hennig-thurau, & puchner, ; verleye et al., ) . for instance, investments in online brand communities or social media platforms were found to strengthen customer-firm relationships if firms listen to their customers and allow for two-way communication (roy et al., a; shao, jones, & grace, ) . recent work on customer engagement also supports the fundamentals of social exchange theory by showing that customers are more likely to engage with brands or firms if they receive valuable resources in return (guo, zhang, & sun, ; harrigan et al., ; roy et al., a) . this research contends that customers receive more valuable resources if companies advance the smartness of their service system, in that higher levels of smartness increase the perceived personalization (kabadayi et al., ; porter & heppelmann, ; roy et al., ) . here, perceived personalization refers to the extent to which customers experience that smart offerings are tailored to their specific needs and preferences (roy et al., ; xu et al., ) . indeed, more personalized services are generated if smart service systems capture more private information about the customers (i.e., awareness), increasingly share this information with connected actors (i.e., connectivity), decide and act more independently (i.e., actuation), and better learn and improve the service over time (i.e., dynamism) (beverungen et al., ; dreyer et al., ) . hence, we predict j o u r n a l p r e -p r o o f that higher levels of smartness go along with higher levels of perceived personalization by customers, which in turn boost customer engagement with smart service system actors. in smart service systems, smart products and service providers perform different roles (beverungen et al., ) . more specifically, the smart product plays a more central role because it is the channel through which service providers enter customers" lives. following the central role of the smart product in smart service systems along with its tangible nature (i.e., smart products as combination of physical and digital components -anke, ; beverungen et al., ; porter & heppelmann, ) , customers are more likely to return their engagement in response to personalized services to the smart product rather than to the service provider in the smart service system. prior research confirms that customers ascribe effortssuch as investments in higher levels of smartness to provide more personalized servicesmainly to the most visible actor (kranzbühler, kleijnen, & verlegh, ) . as the smart product is the most visible actor in the smart service system, customers are more likely to engage with it than with other actors (here, service providers) in the smart service system when more personalized services are offered through higher levels of smartness. therefore, we hypothesize the mediating role of perceived personalization as follows: h a: increased levels of smartness lead to more customer engagement with the smart product and the service provider in the smart service system through perceived personalization. shen & dwayne ball, ). in fact, customer traitssuch as the need for personalizationinfluence a wide variety of customer outcomes (dabholkar & bagozzi, ; meuter, bitner, ostrom, & brown, ) , including customer engagement with brands or firms (islam, rahman, & hollebeek, ; shen & dwayne ball, ). building upon this line of thought, we contend that customer engagement with smart service system actors is shaped by a customer"s need for personalization. we define the need for personalization as a customer"s desire for products and services that resemble the customer"s specific needs and preferences (herbas torrico & frank, ; xu et al., ) . as customers with a high need for personalization are found to value investments of actors in personalized services more than those with a low need for personalization (herbas torrico & frank, ), we expectin line with social exchange theorythat the effect of personalization on customer engagement with different actors in the smart service system is stronger for customers with a high (versus a low) need for personalization. therefore, we hypothesize the moderating role of the need for personalization as follows: h : the positive effect of perceived personalization on customer engagement with the smart product and the service provider in the smart service system is stronger for customers with a high versus a low need for personalization. to achieve more personalized services through higher levels of smartness, companies need to gather more personal information (i.e., awareness), increasingly share this information with other actors (i.e., connectivity), more extensively employ this information to execute tasks more independently (i.e., actuation), and increasingly exploit this information to better learn and adapt the smart offering (i.e., dynamism) (mani & chouk, ; dreyer et al., ) . although the usage of personal information may increase perceived personalization and hence j o u r n a l p r e -p r o o f lead to more engagement with smart service systems, extant research in the context of personalized advertising suggests that these practices may also induce feelings of intrusiveness (edwards, li, & lee, ; gutierrez, o"leary, rana, dwivedi, & calle, ; van doorn & hoekstra, ) . perceived intrusiveness refers to customers" experience that smart products or services are interfering with their life (edwards et al., ; mani & chouk, ) . past literature demonstrates that these interferences increase when customers notice that their personal information is being used by companies (edwards et al., ; mani & chouk, ; papa, mital, pisano, & del giudice, ; wottrich, van reijmersdal, & smit, ). as increases in the level of smartness of service systems imply more and more gathering, sharing, employing, and exploiting of personal data, we predict that higher levels of smartness generate increased perceptions of intrusiveness among customers. in turn, this provoked perceived intrusiveness can decrease customer engagement with smart service systems. indeed, social exchange theory suggests that customer engagement is threatened when customers do not feel cared for or supported by service system actors (cropanzano & mitchell, ; verleye et al., ) . this situation is more likely to emerge when service systems with higher levels of smartness increasingly intrude into customers" lives by gathering, sharing, employing, and exploiting more and more personal information. as mentioned before, smart service systems consist inherently of different types of actorsthat is, smart products and service providerswhich perform different roles (beverungen et al., ) . while the more central role of smart products along with their tangible nature positions them as the main responsible actor for perceived personalization, they may also be perceived as the main culprit for heightened levels of perceived intrusiveness among customers (kranzbühler et al., ) . hence, customers are expected to blame the smart product more than the service provider for perceived intrusions, resulting in j o u r n a l p r e -p r o o f more customer engagement towards the smart product than towards the service provider. hence, we hypothesize the mediating role of perceived intrusiveness as follows: h a: increased levels of smartness lead to less customer engagement with the smart product and the service provider in the smart service system through perceived intrusiveness. h b: the negative effect of smartness through perceived intrusiveness on customer engagement is stronger for the smart product relative to the service provider in the smart service system. meanwhile, prior research suggests that not all customers are equally sensitive to the use of personal information and hence intrusions into their lives (van doorn & hoekstra, ) . therefore, we propose intrusiveness sensitivitythat is, the extent to which customers are receptive for intrusions into their lives (gutierrez et al., ; luna cortés & royo vela, )as an important customer trait in the context of smart services. as mentioned before, customer traits like intrusiveness sensitivity have been demonstrated to affect numerous customer outcomes including customer engagement (dabholkar & bagozzi, ; meuter et al., ; shen & dwayne ball, ; islam et al., ) . more specifically, we expect that the impact of the level of smartness on the perceived intrusiveness is stronger for customers who are more sensitive to intrusions into their lives. therefore, we hypothesize the moderating role of intrusiveness sensitivity as follows: h : the positive effect of smartness on perceived intrusiveness is stronger for customers with a high versus a low level of intrusiveness sensitivity. customer well-being refers to the customer's optimal psychological condition (ryan & deci, ) . detractions from this optimal psychological condition are labeled as customer illbeing, which turns customer ill-being into the counterpart of customer well-being . as widely acknowledged in the well-being literature, customer well-being incorporates both eudaimonic facets (i.e., extent of self-realization) and hedonic facets (i.e., extent of happiness and pleasure) (anderson et al., ; ryan & deci, ) . according to ryan and deci ( ) , eudaimonic and hedonic facets are complementary facets of wellbeing that together provide an extensive picture of a person"s psychological condition. in the context of smart service systems, it has been illustrated that both facets are relevant (e.g., horwood & anglim, ; howells, ivtzan, & eiroa-orosa, ) . with regard to the eudaimonic facet, extant research suggestsin line with self-determination theorythat customers need to belief that they have the competencies necessary to use smart service systems and hence have the abilities to use smart service systems, which is also labeled as self-efficacy (bandura, ; schweitzer & van den hende, ) . as such, self-efficacy reflects customer well-being (la guardia, ryan, couchman, & deci, ; ryan & deci, ) . regarding the hedonic facet, a number of studies point out that anxiety to use new technologies (hereafter, technology anxiety) may mitigate the potential pleasure of using smart service systems (mani & chouk, ; touzani, charfi, boistel, & niort, ; yang & forney, ) . technology anxiety refers thus to feeling apprehensive when being faced with the possibility to use new technology-based, which makes customers avoidant towards technology-enabled services in general (jokisch, schmidt, doh, marquard, & wahl., ) . these higher avoidance motivations reduce customers" competence (eliot & sheldon, ), which resonatesin accordance with self-determination theorywith reduced customer wellbeing (la guardia et al., ; ryan & deci, ; touzani et al., ) . drawing on this reasoning, technological anxiety is an important inhibitor of customer well-beingand thus a j o u r n a l p r e -p r o o f provoker of customer ill-beingin a smart service system context (gelbrich & sattler, ; touzani et al., ) . building upon the aforementioned evidence, selfefficacy and technology anxiety are important facets of customer well-being in the context of smart service systems. while customer well-being is considered as relatively stable, diener, lucas, and scollon ( ) argue that some events or experiences can alter customers" well-being. in this regard, recent research suggests that customer well-being can be influenced by customers engagement with smart service systems actors (lee et al., ; nie et al., ; rotondi, stanca, & tomasuolo, ) . indeed, customer engagement provides a platform through which wellbeing can be affected (e.g., david et al., ; horwood & anglim, ; mende & van doorn, ; roy et al., ) . building upon this line of though, we contend that engaged customers think about, feel about, and use smart service systems in a more intense way (bowden, conduit, hollebeek, luoma-aho, & solem, ; hollebeek et al., ) . as such, increased customer engagement with smart service system actors (here, smart product and service provider) can enable customers to improve their mastery of skills to use smart service systems. drawing from the self-efficacy paradigm of bandura ( ) , the mastery of these smart service system skills enhances customers" self-efficacy, which resonatesin accordance with selfdetermination theorywith customer well-being (la guardia et al., ; ryan & deci, ). as higher levels of self-efficacy are expected to follow from increased customer engagement with smart service system actors, we hypothesize: h : increased levels of customer engagement with the smart product and the service provider in the smart service system lead to higher levels of selfefficacy among customers. meanwhile, technology anxietywhich is another important facet of customer wellbeing in smart service systems (here, smart product and service provider)might also be influenced when customers engage with smart service system actors. more particularly, the more customers engage with ever smarter service systems, the more experience with a specific technology-enabled service is established. this experience with a specific technology-based service (here, smart service systems) mayas outlined in technology anxiety researchmake customers less apprehensive to use new technology-based services in general. these lower levels of avoidance towards technology in general reflect diminished levels of technology anxiety (chua et al., ; niemelä-nyrhinen, ) . therefore, we contend that increased customer engagement with smart service system actors can result in lower levels of technology anxiety (jokisch et al., ) , which resonatesin accordance with self-determination theorywith reduced customer ill-being and thus enhanced customer well-being la guardia et al., ) . building upon this aforementioned reasoning, we hypothesize: h : increased levels of customer engagement with the smart product and the service provider in the smart service system lead to lower levels of technology anxiety among customers. the main empirical study tests our hypotheses regarding the effect of smartness on customer well-being through customer engagement with the smart product and the service provider in the smart service system, while taking personalization mechanisms and intrusiveness mechanisms into consideration. as background to this scenario-based study, an exploratory study develops and evaluates (i.e., manipulation and realism) scenarios that manipulate the distinct level of smartness of the smart service system. to develop the manipulations of smartness, this exploratory study builds on the insights from our systematic literature review. based upon this review, we identified awareness, connectivity, actuation, and dynamism as the four inherently linked characteristics of smartness of service systems (see table ). hence, we created scenarios with low versus high levels of awareness, connectivity, actuation, and dynamism to manipulate the level of smartness. to investigate scenario manipulation and realism, we conduct a scenario-based, between-subject experiment. in all scenarios, participants read that they had bought a smart fridge that offers smart services. this smart fridge setting was deliberately chosen as the household penetration of smart home appliances is very high and predicted to keep growing exponentially over the upcoming years (statista, ) . specifically, the participants read that the smart fridge is able to compose a grocery list and to order these groceries at the customer"s preferred grocery store. in this context, a smart product (here, smart fridge) and a service provider (here, grocery store) constitute the smart service system. the low smartness scenario represents a smart service system characterized by low awareness, connectivity, actuation, and dynamism, while high levels of these smartness characteristics are present in the high smartness scenario (see table for detailed scenario descriptions). to verify whether the low smartness scenario still meets the criteria of smart service systems (i.e., four smartness characteristics), we also developed a "no smartness" scenario describing a smart fridge without smartness characteristics. insert table about here ====================== j o u r n a l p r e -p r o o f after reading the scenario, the respondents received a questionnaire in which they were asked to evaluate the realism of the scenarios on a -point likert scale by means of three items adopted from the literature (dabholkar & bagozzi, ; van vaerenbergh, vermeir, & larivière, ) : "what is described in this scenario could also happen in real life", "the scenario seems realistic", and "i had no difficulty imagining myself in the situation" (α = . ). next, the respondents also evaluated the smartness manipulation with an overall smartness item ("according to you, how smart is this fridge?", ranging from zero to hundred). additionally, we measured the four smartness characteristics (see appendix) using scales proposed in rijsdijk, hultink, and diamantopoulos ( ) and rijsdijk and hultink ( ) . data was collected by means of mechanical turk (mturk). via this platform, the questionnaire was presented to u.s. citizens, as the penetration of smart home services in the u.s. is the highest worldwide and continuously keeps increasing (statista, ) . specifically, participants were randomly assigned to one of three experimental conditions (no smartness, low smartness, high smartness). in line with the recommendation for using mturk as a sampling method (crump, mcdonnell, & gureckis, ; goodman & paolacci, ) , we performed the following actions: ( ) paying an appropriate remuneration to encourage the respondents to fill out the questionnaire accurately (i.e., $ ), ( ) paying every respondent even if the results could not be used, ( ) pilot-testing the questionnaire (n = ) to avoid misinterpretation and improve clarity, ( ) asking respondents with an approval rate on mturk of % or higher, and ( ) monitoring mturk forums to screen for information being shared regarding the survey (goodman & paolacci, ; paolacci, chandler, & ipeirotis, ) . after excluding three respondents who incorrectly filled in the control question, the final sample included viable responses (m age = . ; . % male) with respondents in the j o u r n a l p r e -p r o o f no smartness condition, in the low smartness condition, and in the high smartness condition. the results indicate that the realism of the three scenariosno smartness (m = . ; sd = . ), low smartness (m = . ; sd = . ), and high smartness (m = . ; sd = . )is above the midpoint (p = . ). in addition, the realism of the low and high smartness is significantly higher than (p = . ), resulting in very realistic and easy to imagine scenarios (dabholkar, ; giebelhausen, robinson, sirianni, & brady, the results of our exploratory study demonstrate that the low and high smartness scenarios differ in terms of smartness. in addition, these scenarios were perceived as realistic and easy to imagine. moreover, the low smartness scenario differs from the no smartness scenario, thereby demonstrating that the low smartness scenario still meets the criteria of a smart service system (i.e., the four smartness characteristics). as this research aims to provide insight into smartness as an enabler of customer well-being through customer engagement and its underlying mechanisms, we will compare the low and high smartness scenario in the main study. j o u r n a l p r e -p r o o f to test the hypotheses depicted in the conceptual model (see figure ), we conducted a scenario-based, between-subjects experiment. in this experiment, respondents were randomly assigned to the low or the high smartness conditions developed in the exploratory study. afterwards, the respondents filled out a questionnaire about their well-being (here, selfefficacy and technology anxiety), their engagement with the smart product and the service provider, and their perceptions (here, perceived personalization and perceived intrusiveness) along with their corresponding importance (here, need for personalization and intrusiveness sensitivity), thereby using validated scales from the literature (see appendix). for selfefficacy and customer engagement, a selection of the original items was usedin line with previous smart service system and engagement literature in smart service contexts (e.g., fan et al., ; islam et al., ; mani & chouk, to ensure the fit with our smart fridge context and our scenario-based design. in addition, the questionnaire also included age, gender, and education level, as these control variables were found to influence customer engagement and customer well-being in previous research (horwood & anglim, ; islam, hollebeek, rahman, khan, & rasool, ) . all items were measured on -point likert scales. after excluding the respondents that answered the control questions incorrectly, the final sample included respondents (m age = . ; . % male) with respondents in the low smartness condition and respondents in the high smartness condition. to assess the impact of a low versus a high level of smartness on customer well-being through ( ) customer perceptions and their associated importance and ( ) customer engagement with the smart product and the service provider in the smart service system, we used a mediation approach (zhao, lynch jr, & chen, ) with bayesian estimation (yuan & mackinnon, ) in mplus. in line with gelman and rubin ( ) , we ran three j o u r n a l p r e -p r o o f independent markov chain monte carlo (mcmc) chains with different starting points and , iterations each, by which the first half is considered as the "burn-in" phase and the remaining half is used to estimate the posterior distribution for the parameters. to assess the convergence of the mcmc algorithm, we inspected the gelman-rubin convergence statistic r, autocorrelation plots, and trace plots of the residual variance for the parameter estimates. specifically, given the last , iterations (used to estimate the parameters), the largest value of the gelman-rubin convergence statistic r ranged between . and . (note that yuan and mackinnon ( ) have suggested that a value of r close to [the highest cut-off being . ] is an indication of reasonable convergence). hence, this investigation provided evidence of the mcmc algorithm"s convergence. as suggested by iacobucci ( ) and yuan and mackinnon ( ) , the following equations were jointly estimated using structural equation modeling (sem) in order to test our proposed conceptual model: ( ) in which cwb iw denotes the customer well-being of individual i (i = to ) for well-being dimension w, in which two dimensions (w = to ) are jointly modeled: self-efficacy (se) and technology anxiety (ta) respectively. ce id denotes the customer engagement of individual i for engagement dimension d, in which six dimensions are discerned (d = to ): cognitive, affective, and behavioral engagement with the smart product, and cognitive, affective, and behavioral engagement with the service provider respectively.  iw ,  id , i and e i are the error terms with intercorrelation and cv i is a vector of the control variables (age, gender, and education level). to test h a and h b, we usedin line with prior research (e.g., larivière et al., ) -the widely adopted procedure of zhao et al. ( ) . in accordance with zhao et al."s ( ) procedure, an additional parameter estimate for the mediating influence of perceived personalization is calculated. specifically, the impact of smartness on customer engagement via the mediation of perceived personalization is defined as a new parameter (by means of the "model constraint" function in mplus; see muthén, , p we ran a forward vst to further assure the absence of multicollinearity as this test assesses multicollinearity"s degree and impact on our analysis (chatterjee, hadi, & price, ) . the results show that the vst model"s parameter significance, sign, and magnitude correspond to the full model results. on the basis of the vif values and vst analyses, we conclude that multicollinearity is not a problem in our dataset (chatterjee et al., ; hair et al., ) . common method bias (cmb) was assessed by means of the harman"s single-factor test (podsakoff, mackenzie, lee, & podsakoff, ) and the marker variable technique (lindell & whitney, ) . the harman"s single-factor test makes use of exploratory factor analysis to check whether a single factor emerges or one general factor accounts for the majority of the covariance among the measures. the results showed ten factors, by which the first factor accounted for . % of the variance and all factors together explained . % of the variance. hence, none of these factors accounted for the majority of the covariance among the items, providing us a first indication that cmb was not a serious threat to our analyses (podsakoff et al., ) . second, we employed the marker variable technique (lindell & whitney, ) and used the marker variable (i.e., "satisfaction with living environment") as proposed by yee, yeung, and cheng ( ) . since this marker variable is theoretically unrelated to the variables under investigation, cmb can be assessed based on the correlation between the marker variable and the research variables. the average size of the correlation (r m ) between the marker variable and key constructs was found to be . , which is below the cut-off of . that is suggested and based on malhotra, kim, and patil's ( , p. ) sensitivity analysis. additionally, as outlined by ye, marinova, and singh ( ) , we ran an alternative model in which we partialed out potential cmb problems by controlling for the j o u r n a l p r e -p r o o f marker variable in all equations. our results indicated that none of the variables (both significance level and parameter magnitude) were affected by the inclusion of the marker variable. based on the results from the harman"s single-factor test and the marker variable technique, we conclude that cmb is not a significant concern in our dataset (lindell & whitney, ; podsakoff et al., ) . table shows the results of the marker variable test and the descriptive statistics. in addition, we conducted a confirmatory factor analysis (cfa; r studio) to evaluate construct validity. the measurement model for the sample performed well. indeed, the comparative fit index (cfi), . , and tucker-lewis index (tli), . , were both above common benchmarks of . . furthermore, the root mean square error of approximation (rmsea) was . , which is below the advised level of . , thereby reflecting a good fit (hu & bentler, ; netemeyer, bearden, & sharma, ) . the individual items and item loadings are presented in the appendix. the sample showed convergent validity, since all construct reliabilities (cr) were above . , which is considered to be a desirable construct reliability (bagozzi & yi, ) and all average variances extracted (ave) exceeded . (see appendix). additionally, there is evidence for discriminant validity when comparing the square root of the ave with the factor correlations (see table ) (fornell & larcker, ) . insert table about here ====================== the extent to which the empirical results support the hypotheses is summarized in table . the remainder of this section elaborates in detail upon the results related to each hypothesis. insert table about here ====================== j o u r n a l p r e -p r o o f table presents the model estimates, which show that smartness has a positive significant effect on perceived personalization ( = . ). moreover, our findings provide strong support for the positive impact of smartness on all customer engagement dependents through the mediation of perceived personalization (multiplying  and  d resulting in . , . , . , . , . , . for respectively ce d , ce d , ce d , ce d , ce d , and ce d ), thereby supporting h a. the standardized parameter estimates of the indirect effect reveal that these mediation mechanisms are much stronger for customer engagement dimensions with the smart product (  d is . for cognitive, . for affective, and . for behavioral engagement towards the smart product; i.e., respectively ce d , ce d , and ce d ) compared to the respective customer engagement dimensions with the service provider (  d is . , . and . for respectively cognitive, affective and behavioral engagement towards the service provider; i.e., respectively ce d , ce d , and ce d ). post-hoc significance tests (procedure outlined by clogg, petkova, & haritou, ) further detail on the statistical differences with respect to the mediating impact of perceived personalization on customer engagement dimensions with the smart product versus customer engagement dimensions with the service provider. more precisely, these post-hoc tests reveal that the parameter estimates for this mediation mechanism ( ×  d ) (i) for cognitive engagement with the smart product is significantly higher than cognitive engagement with the service provider (i.e., p-value is . ), (ii) for affective engagement with the smart product is significantly higher than affective engagement with the service provider (i.e., p-value is . ), and (iii) for behavioral engagement with the smart product is significantly higher than behavioral engagement with the service provider (i.e., p-value is . ). as such, h b is supported. in addition, table reveals that the parameter estimates ( d ) for the moderating impact of need for personalization on the relationship between perceived personalization and customer engagement with the smart service system actors ( d is . , . , . , . , j o u r n a l p r e -p r o o f . , and . for respectively ce d , ce d , ce d , ce d , ce d , and ce d ) are significantly positive. the positive impact of perceived personalization on the customer engagement dimensions is thus found to be more pronounced in case of a higher need for personalization. hence, h is supported. insert table about here ====================== regarding intrusiveness mechanisms, we observe that higher levels of smartness are also associated with higher levels of perceived intrusiveness ( = . ). this is statistically different (p-value < . ; clogg et al., ) and almost half of the magnitude of the effect size that we observed for the impact of smartness on perceived personalization ( = . ). furthermore, the additional calculated parameter estimates in table show that smartness has a significant indirect impact on all customer engagement dependents through the mediation of perceived intrusiveness (multiplying  and  d ). more particularly, the estimates reveal that this mediation is negative for affective and behavioral customer engagement with the smart product (  d is - . and - . for respectively ce d and ce d ) in line with our hypotheses. interestingly, a significant, but positive mediation effect of perceived intrusiveness is found for cognitive customer engagement with the smart product (  d is . for ce d ), as well as for cognitive, affective and behavioral customer engagement with the service provider (  d is . , . and . for respectively ce d , ce d and ce d ). therefore, h a is only partly supported (i.e., only supported for ce d and ce d ). posthoc tests (procedure outlined by clogg et al., ) further reveal that the negative parameter estimates for this mediation mechanism (  d ) is significantly lower (i) for affective engagement with the smart product than affective engagement with the service provider (i.e., p-value is . ), and (ii) for behavioral engagement with the smart product than behavioral engagement with the service provider (i.e., p-value is . ). in contrast, for cognitive j o u r n a l p r e -p r o o f engagement with the smart product we observed a positive parameter estimate, whereas a negative parameter estimate was postulated. therefore, h a is only partly supported (i.e., only supported for ce d and ce d ). in addition, we found strong evidence that the impact of smartness on perceived intrusiveness is moderated by customers" intrusiveness sensitivity, as hypothesized ( = . ). therefore, h is supported. finally, the effect of customer engagement with smart product and the service provider in ever smarter service systems on customer well-being was assessed. regarding self-efficacy, table shows that cognitive and behavioral customer engagement with the smart product have a positive effect on self-efficacy ( w d is . for cognitive ce d and  w d is . for behavioral ce d ), while cognitive customer engagement with the service provider has a negative effect on self-efficacy ( w d is - . for cognitive ce d ). meanwhile, the other customer engagement dimensions had insignificant effects on self-efficacy. hence, h is partially supported. concerning technology anxiety, the estimates reveal that behavioral customer engagement with the smart product has a negative effect on technology anxiety ( w d is - . for behavioral ce d ), while cognitive customer engagement with the service provider has a positive effect on technology anxiety ( w d is . for cognitive ce d ). meanwhile, the other customer engagement dimensions had insignificant effects on technology anxiety. these findings partially support h . to evaluate the total effect of smartness on customer well-being , we performed three analyses (see respectively panel a, b, and c in table ). first, we investigated the total effect of smartness on customer engagement with smart products and service providers in smart service systems by simultaneously considering the direct and indirect impact of smartness on the six customer engagement dependents. panel a of table provides a summary of the total we thank the anonymous reviewer for drawing our attention to this point. table copies these three effects from table , and further calculates the corresponding total effect of smartness on customer engagement with the smart service system actors (that is obtained by means of the "model constraint" function in mplus; see muthén, , p. ) . the total effect estimates reveal that higher levels of smartness have a significant positive effect on customer engagement with the smart product ( . for cognitive, . for affective, and . for behavioral; i.e., ce d , ce d , and ce d ; all significant at p-value < . ). in contrast, the total effect of smartness on customer engagement with the service provider is found to be insignificantly different from zero (- . for cognitive, . for affective, and - . for behavioral; i.e., ce d , ce d , and ce d ; all p-values > . ). second, panel b of table further details the total effect of smartness on customer engagement while considering customers' need for personalization and intrusiveness sensitivity. specifically, panel b details this total effect in four situations in which customers" need for personalization and intrusiveness sensitivity both vary between low and high. in case of high need for personalizationregardless of the level of intrusiveness sensitivity (i.e., situations and )we observe a stronger impact of the level of smartness on customer engagement with the smart product, as well as the emergence of a significant impact of smartness on affective engagement with the service provider compared to the populationaveraged total effect reported in panel a. in contrast, when need for personalization is lowregardless of the level of intrusiveness sensitivity (i.e., situations and ) -panel b shows that smartness exhibits a weaker impact on customer engagement. specifically, the impact of j o u r n a l p r e -p r o o f smartness on affective engagement with both the smart product and the service provider becomes insignificant and the impact of smartness on behavioral engagement with the smart product decreases in effect size, while the total effect of smartness on cognitive engagement with the smart product remains quite stable and still very high (i.e., comparing situations and with situations and ). taken together, these insights of panel b demonstrate that the total effect of smartness on customer engagement not only depends on the mediating mechanisms, but also on the moderating influence of need for personalization. note that beside these moderating influences, need for personalization and intrusiveness sensitivity also exert direct influences on customer engagement and perceived intrusiveness respectively (see respectively  d and  in table ). finally, we disentangle the total effect of smartness on customer well-being through the double mediation of customers" perceptions and engagement, thereby also accounting for customers" need for personalization and intrusiveness sensitivity. panel c of table displays the total effect of smartness by multiplying (by means of the aforementioned "model constraint" function) the total effect of smartness on customer engagement (see panel a and b for the estimates, respectively, with and without customers" need for personalization and intrusiveness sensitivity) with the effect of customer engagement on self-efficacy and technology anxiety ( wd from table ). first of all, panel c (see first line) shows the total effect without accounting for customers" need for personalization and intrusiveness sensitivity. the results indicate that higher levels of smartness significantly enhance customer self-efficacy. further, panel c shows that a high need for personalization strengthens this positive relationship between the level of smartness and self-efficacy (see situations and ). meanwhile, the total effect of the level of smartness on technology anxietywhen we do not account for customers" need for personalization and intrusiveness sensitivityis negative, but not significant. notably, this negative effect of the level smartness on technology-anxiety j o u r n a l p r e -p r o o f becomes marginally significant in case customers have a high personalization need and a low sensitivity to intrusions (see situation ). in sum, these insights of panel c reveal that (i) the total impact of the level of smartness on customer well-being primarily effectuates through self-efficacy in all situations, but is found to be more pronounced for customers with a high need for personalization, and (ii) the most optimal customer well-being implications (here, both enhancing self-efficacy and lowering technology anxiety at the same time) of higher levels of smartness can be achieved when customers have a high need for personalization in tandem with a low intrusiveness sensitivity. insert table about here ====================== we ran several robustness checks. first, we ran five models to show that we obtain similar findings for the focal effects (e.g., van heerde, dinner, & neslin, ), but only the last one (m ) is reported in this manuscript (see table second, an additional model (m ) was assessed in which a marker variable was included to test for the potential influence of common method bias (lindell & whitney, in similar vein, the comparison of m and m discerned similar results in terms of signs, significance level, and effect sizes, thereby demonstrating evidence of stable parameter estimates. additional post-hoc tests (clogg et al., ) revealed that the observed differences between both models were not found to be statistically different from each other (lowest pvalue is . ). while path analysis (here, m ) is a special case of sem (here, m ), the main difference is that path analysis assumes that all variables are measured without error, whereas sem uses latent variables to account for measurement error. although sem models requires more parameters to be estimated and thus may need more iterations to obtain model convergence, our main model (m ) converged satisfactorily. in addition, as the model j o u r n a l p r e -p r o o f findings did reveal evidence of significant measurement errors, m the model that accounts for these measurement errors in the modelingis preferred. finally, we estimated a last model (m ) without any endogeneity correction. specifically, we restricted the correlation in the error terms of the customer well-being dependents to zero and excluded the control variables (e.g., van heerde et al., ) . a comparison with the main model (m ) revealed that the focal effects were replicated in terms of signs, significance, and effect sizes. as such, supporting the robustness of our model (m ). as companies are increasingly advancing the level of smartness of their service system (langley et al., ) , this research investigates the implications of higher levels of smartness for customer well-being through customer engagement and personalization and intrusiveness mechanisms. the findings contribute to smart service systems, customer well-being, and customer engagement literature in various ways. based upon a systematic integration of a wide variety of smart product, smart service, and smart service system descriptions and definitions, this research identifies awareness, connectivity, actuation, and dynamism as key characteristics of smartness. by doing so, this research contributes to an important and ongoing debate in the smart service system literature about the definition of smartness (e.g., langley et al., ; lim & maglio, ) . specifically, smartness is a multidimensional phenomenon, by which awareness, connectivity, actuation, and dynamism are inherently linked to one another. this multidimensional conceptualization of smartness allows researchers to better conceptualize and operationalize smartness in their work, as well as to reflect upon the level of smartness of their smart service systems. by showing that the level of smartness influences customer well-being in smart service systems, this research also advances the smart service system literature where customer well-being only recently gained attention. indeed, growing attention is devoted to customer well-being when using smartphones (e.g., david et al., ; horwood & anglim, ) , smart wearables (e.g., papa et al., ) , and smart retail technology (e.g., roy et al., ) . while these studies demonstrate that the usage of smart service systems can affect customer well-being, these studies have largely ignored the impact of smartness of these service systems on well-being. in other words, the level to which these service systems incorporate awareness, connectivity, actuation, and dynamism and its subsequent impact on customer well-being remained unclear. by addressing this theoretical gap, this research provides insight into the link between smartness and customer well-being (here, self-efficacy and technology anxiety). to date, hollebeek and belk ( ) point out that scant knowledge exists on customer engagement with smart technology and its relationship with well-being. in response to this gap, the present research unravels the smartness-well-being relationship by investigating the mediating role of customer engagement. specifically, this research shows that higher levels of smartness stimulate customer well-being through customer engagement with the smart product. indeed, customer engagement with the smart product increases customers" selfefficacy while decreasing their technology anxiety, thereby building on self-determination theory. meanwhile, our empirical evidence suggests that customer engagement with service providers reduces customer well-being as it decreases customers" self-efficacy and increases customers" technology anxiety. by exposing how customer engagement influences customer well-being in terms of its eudaimonic facet (here, self-efficacy) as well as its hedonic facet j o u r n a l p r e -p r o o f (here, technology anxiety), this inquiry provides an extensive picture of the engagement-wellbeing relationship in the context of smart service systems. as customer engagement with smart products has a different role with regard to the smartness-well-being relationship than customer engagement with service providers, this research also shows how the technological nature of smart service system actors may affect their impact on customer well-being. specifically, smart products (e.g., smart fridge) arein contrast with service providers such as a grocery storetechnological in nature. by engaging with technological actors like smart fridges, customers becomein line with the familiarity principle (brown, fuller, & vician, )more acquainted with technology-based offerings, thereby stimulating their technology-related self-efficacy and even reducing their technology-related anxiety in general. in contrast, when customers are increasingly engaging with service providers like grocery stores, the technological aspects of the smart service system may become less salient and hence reduce customers" self-efficacy and increase their technology anxiety. by unraveling how customer perceptions along with their associated importance shape the smartness-engagement relationship in smart service systems, this research adds to the understanding of complex service systems as urged upon by engagement researchers (e.g., alexander et al., ) . specifically, this study reveals that higher levels of smartness stimulate customer engagement with the smart product and even customer engagement with the service provider by offering personalization benefits (cf. mediating role of perceived personalization). as such, this study shows that personalization benefits arein accordance with social exchange theoryan important driver of customer engagement with different actors in a service system (roy et al. a) . meanwhile, higher levels of smartness decrease in line with social exchange theorybehavioral engagement with the smart product through j o u r n a l p r e -p r o o f intrusiveness perceptions (cf. mediating role of perceived intrusiveness). although these intrusiveness perceptions increase cognitive engagement with the smart product, it is conceivable that customers think more about this actor as it is physically intruding into their lives. as customers may thus mainly perceive smart productsand not service providersas central actors in smart service systems, service providers are not held responsible for intrusiveness perceptions. this is reflected by the absence of negative implications of intrusiveness perceptions for customer engagement with the service provider, which may thus stem from attribution mechanisms. indeed, kranzbühler et al. ( ) suggest that both rewards and blames are primarily associated with the most visible actor (here, smart product). further inquiry unveils the necessity to not solely account for customer perceptions (here, perceived personalization and perceived intrusiveness), but also for the importance that customers attach to it (here, need for personalization and intrusiveness sensitivity) as the impact of these perceptions is found to be more pronounced when customers attach more importance to it (e.g., the influence of smartness on perceived intrusiveness is stronger for customers with higher intrusiveness sensitivity). as customer heterogeneity significantly influences the impact of smartness on customer well-being via customer engagement in smart service systems, it should be considered in future research on customer well-being and customer engagement. this research helps managers to make more informed decisions about the level of smartness of their service systems in various ways. first, our conceptualization of smartness along its four inherently linked key characteristics (i.e., awareness, connectivity, actuation, and dynamism) provides managers involved in a smart service system with a framework to both design and evaluate the system"s level of smartness. in addition, this study provides these managers with insights into the customer well-being implications of increasing the level of j o u r n a l p r e -p r o o f smartness. specifically, they are advised to invest in higher levels of smartness, as these investments boost customer well-being. to further enhance customer well-being, these managers may also benefit from making customers" need for personalization more salient and their intrusiveness sensitivity less pronounced, for instance in advertisements about their smart service systems. second, this study aids managers to foster customer engagement with smart products, because higher levels of smartness stimulate cognitive, affective and behavioral engagement with smart products. interestingly, the most optimal customer engagement returns are observed when customers report a high need for personalization, regardless of their intrusiveness sensitivity. hence, managers of smart products are advised to invest in all smartness characteristics (i.e., awareness, connectivity, actuation, dynamism) and clearly communicate about the personalization benefits of these smartness investments to their customers. third, this research also guides service providers about whether and how to be part of a smart service system. overall, this research suggests that service providers benefit from forming service systems with higher levels of smartness, especially when their customers attach importance to personalized offerings. in those situations, customers may show more affective engagement towards the service provider. hence, managers of service providers are also advised to communicate the personalization benefits when joining service systems with a high level of smartness or when investing in the smartness of service systems to which they belong. this study sheds light on the implications of higher levels of smartness for customer wellbeing through customer engagement and customer perceptions along with their associated importance. some limitations, however, suggest directions for future research. first, the j o u r n a l p r e -p r o o f present research centered on smart service systems with low versus high smartness. future research, however, could try to vary the level of smartness even more to detect curvilinear effects, similar to the uncanny valley effects related to the appearance of humanoid robots (mori, ) . second, previous research also indicates that customer well-being can operate as a driver of customer engagement (e.g., horwood & anglim, ) . hence, it might be interesting for future research to investigate the reversed effect of well-being on customer engagement. third, the present research focuses on smart service systems consisting of one smart product and one service provider. future research can elaborate on customer engagement in the context of smart service systems in which more than two actors are involved. here, researchers can explore how actors with different roles and positions in the smart service system can boost customer well-being in return for increasing the level of smartness. fourth, a scenario-based experiment was the most appropriate research design in this context, because service systems with high smartness are not commercialized yet. nevertheless, a scenario-based experiment has its limitations in terms of gaining insight into the well-being implications (here, self-efficacy and technology anxiety) of increasing the level of smartness of service systems. therefore, future research could use other research methods such as field studies and field experimentsand take different well-being aspectslike belongingness or emotional healthinto consideration. finally, the empirical study examined one smart service system (here, smart fridge system) with respondents from one country (here, u.s.). as such, future research can explore the conditions under which customer engagement emerges in other settings and/or countries. by empirically investigating the smartness-well-being relationship through customer engagement with different smart service system actors and the underlying mechanisms (here, customer perceptions and their corresponding importance), this research provides a detailed j o u r n a l p r e -p r o o f and nuanced reply to the compelling question "the smarter, the better?". in sum, the overall answer is "the smarter, the better!" as higher levels of smartness ( ) go along with personalization perceptions that exceed intrusiveness perceptions ( ) through which especially cognitive, affective and behavioral customer engagement with the smart product is generated and to some extent even affective customer engagement with the service provider is generated, ( ) which results in improved customer well-being (i.e., more self-efficacy and sometimes less technological anxiety) through the generated cognitive and behavioral customer engagement with the smart product, especially for customers with a high need for personalization. the ability to sense information related to the smart service system and/or its surroundings. " … must build intelligence-that is, awareness and connectivity-into the products themselves." (allmendinger & lombreglia, ) "the key attributes of a smart technology are the ability to acquire information from the surrounding environment …" (marikyan, papagiannidis, & alamanos, ) "a smart service system is a service system capable of learning, dynamic adaptation (d), and decision making (ac) […] a smart service system is a service system that controls things for the users (ac) based on the technology resources for sensing (aw), connected network (c), context-aware computing (ac), and wireless communications (c)." (lim & maglio, ) "smart services are enabled by smart products that are both connected (c) and intelligently aware (aw) to enable efficient operation, optimization, analysis, integration and other digitally-enabled business functions (ac; d)" (klein, biehl, & friedli, ) "[…] "smart service" that is based on monitoring (aw), optimization (d), remote (c) control (ac), and autonomous (ac) adaptation of products (d)" (beverungen et al., ) "these connected devices (c) can sense the surroundings (aw) and engage in real-time data collection (aw), communication (c), interaction (ac), and feedback (d)" (roy, balaji, quazi, & quaddus , b ) the ability to connectthrough the internet of things (iot)different actors in the smart service system, namely customers, smart products, and service providers. " … ability of smart objects to: (i) be identifiable (anything identifies itself), (ii) to communicate (anything communicates) and (iii) to interact (anything interacts)either among themselves, building networks of interconnected objects, or with end-users or other entities in the network." (miorandi, sicari, de pellegrini, & chlamtac, ) "services provided based on the data from connected products are called "smart services" in this paper." (anke, wellsandt, & thoben, ) the ability to decide and act independently based on computational processes. "smart services are iot-based services that embody new capacities […] autonomy (carrying out automatic actions without the user's intervention)" (mani & chouk, ) "smart products distinguish themselves from traditional products by their ability to process information" (rijsdijk & hultink, ) the ability to learn and adapt based on the relational and cyclical nature of smart service systems. "[…] smart services should be able to adapt based on changing customer and situational input." (kabadayi et al., ) "smart services are individual, highly dynamic and quality-based service solutions…" (dreyer et al., ) j o u r n a l p r e -p r o o f imagine that you bought a smart fridge with the following service characteristics for ordering groceries at your preferred grocery store: the smart fridge can connect with you via devices as smartphones and with another actor, namely your preferred grocery store. the smart fridge cannot connect with other actors, such as your garbage bin (that registers what you throw away including non-fridge food and beverages), your smart thermostat (that tracks weather and seasonal conditions), or social media (that gathers info about consumption trends). the smart fridge can connect with you via devices as smartphones. the smart fridge can connect with other actors, such as your preferred grocery store, your smart garbage bin (that registers what you throw away including non-fridge food and beverages), your smart thermostat (that tracks weather and seasonal conditions), or social media (that gathers info about consumption trends). the smart fridge does use sensors to keep an eye on the products in the fridge (e.g., a box of eggs or a carton of milk). the smart fridge does not gather detailed information about the products (e.g., expiration dates) or text, audio and visual information communicated to the fridge by you or a household member, such as upcoming consumption needs, planned events or holidays. the smart fridge does use sensors to keep an eye on the products in the fridge (e.g., a box of eggs or a carton of milk) or detailed information about the products (e.g., expiration dates). the smart fridge does gather text, audio and visual information communicated to the fridge by you or a household member, such as upcoming consumption needs, planned events or holidays. the smart fridge can propose a grocery list. you still have to add or remove items to the list. the smart fridge cannot send the grocery list to the grocery store. you still have to send the order to the grocery store. the smart fridge can compose a grocery list. you have to do nothing. the smart fridge can send the grocery list to the grocery store. you have to do nothing. the smart fridge does save one prior order. the smart fridge does not learn more about the household's habits, preferences and previous choices over time, such as consumption patterns, planned events or holidays, and seasonal trends. the smart fridge does save all prior orders. the smart fridge does learn more about the household's habits, preferences and previous choices over time, such as consumption patterns, planned events or holidays, and seasonal trends. j o u r n a l p r e -p r o o f note. ce = customer engagement; all variables are measured on a -point likert scale; sd = standard deviation; cr = composite reliability; cr. α = cronbach"s alpha; the diagonal (in italics) shows the square root of the ave for each construct; the numbers below the diagonal represent the correlations among constructs; correlation after common method adjustment (r m = . ) are reported above the diagonal. * p < . ; ** p < . (two-tailed tests) j o u r n a l p r e -p r o o f table h a: increased levels of smartness lead to more customer engagement with the smart product and the service provider in the smart service system through perceived personalization.  supported for cognitive, affective and behavioral engagement with the smart product and supported for cognitive, affective and behavioral engagement with the service provider. h b: the positive effect of smartness through perceived personalization on customer engagement is stronger for the smart product relative to the service provider in the smart service system.  supported for cognitive, affective and behavioral engagement with the smart product, and supported for cognitive, affective and behavioral engagement with the service provider. h : the positive effect of perceived personalization on customer engagement with the smart product and the service provider in the smart service system is stronger for customers with a high versus a low need for personalization.  supported for cognitive, affective and behavioral engagement with the smart product, and supported for cognitive, affective and behavioral engagement with the service provider. h a: increased levels of smartness lead to less customer engagement with the smart product and the service provider in the smart service system through perceived intrusiveness.  supported for affective and behavioral engagement with the smart product;  opposite effects are observed for cognitive engagement with the smart product, and for cognitive, affective, and behavioral engagement with the service provider. h b: the negative effect of smartness through perceived intrusiveness on customer engagement is stronger for the smart product relative to the service provider in the smart service system.  supported for affective and behavioral engagement with the smart product;  not supported for cognitive engagement with the smart product since a positive effect was observed in h a. h : the positive effect of smartness on perceived intrusiveness is stronger for customers with a high versus a low level of intrusiveness sensitivity. supported h : increased levels of customer engagement with the smart product and the service provider in the smart service system lead to higher levels of selfefficacy among customers.  supported for cognitive and behavioral engagement with the smart product;  an opposite effect is observed for cognitive engagement with the service provider;  no effects are observed for affective engagement with the smart product, and affective and behavioral engagement with the service provider. h : increased levels of customer engagement with the smart product and the service provider in the smart service system lead to lower levels of technology anxiety among customers.  supported for behavioral engagement with the smart product;  an opposite effect is observed for cognitive engagement with the service provider;  no effects are observed for cognitive and affective engagement with the smart product, and affective and behavioral engagement with the service provider. j o u r n a l p r e -p r o o f the total impact (parameter estimates) of smartness on customer well-being via the double mediation of (i) perceived personalization and perceived intrusiveness and (ii) customer engagement, (iii) thereby also accounting for the moderating influence of need for personalization and intrusiveness sensitivity customer well-being (cwb) self-efficacy (cwb w ) technology anxiety (cwb w ) total effect (through pp, pi and ce) , * - . total effect accounting for customers' np and is ( situations ) . low np and low is , * - , . high np and low is , * - , a . low np and high is , * - , . high np and high is , * - , zooming out: actor engagement beyond the dyadic four strategies for the age of smart services -harvard business review norway: 'deeply intrusive' covid- contacttracing app halted transformative service research: an agenda for the future design-integrated financial assessment of smart services modelling of a smart service for consumables replenishment -a life cycle perspective. enterprise modelling and information systems architectures the internet of things: a survey on the evaluation of structural equation models self-efficacy: toward a unifying theory of behavioral change smart service systems and viable service systems: applying systems theory to service conceptualizing smart service systems exchange and power in social life customer engagement through personalization and customization the process of customer engagement: a conceptual framework engagement valence duality and spillover effects in online brand communities working group on education: digital skills for life and work actor engagement in networks: defining the conceptual domain customer engagement: conceptual domain, fundamental propositions, and implications for research consumer engagement in a virtual brand community: an exploratory analysis who's afraid of the virtual world? anxiety and computer-mediated communication regression analysis by example factors for and against resistance to smart services: role of consumer lifestyle and ecosystem related variables statistical methods for comparing regression coefficients between models social exchange theory: an interdisciplinary review evaluating amazon"s mechanical turk as a tool for experimental behavioral research computer anxiety and its correlates: a meta-analysis consumer evaluations of new technology-based self-service operations: an investigation of alternative models of service quality an attitudinal model of technology-based self-service: moderating effects of consumer traits and situational factors too much of a good thing: investigating the association between actual smartphone use and individual well-being the "what" and "why" of goal pursuits: human needs and the self-determination of behavior beyond the hedonic treadmill: revising the adaptation theory of well-being focusing the customer through smart services: a literature review forced exposure and psychological reactance : antecedents and consequences of the perceived intrusiveness of pop-up ads avoidance achievement motivation: a personal goals analysis communication from the commission to the european parliament, the council, the european economic and social committee and the committee of the regions on the digital education action plan shaping europe"s digital future the impact of the quality of intelligent experience on smart retail engagement. marketing intelligence and planning a taxonomy and archetypes of smart services for smart living evaluating structural equation models with unobservable variables and measurement error anxiety, crowding, and time pressure in public self-service technology acceptance inference from iterative simulation using multiple sequences touch versus tech: when technology functions as a barrier or a benefit to service encounters crowdsourcing consumer research the privacy-personalization paradox in mhealth services acceptance of different age groups using privacy calculus theory to explore entrepreneurial directions in mobile location-based advertising: identifying intrusiveness as the critical risk factor multivariate data analysis: a global perspective customer engagement and the relationship between involvement, engagement, self-brand connection and brand usage intent consumer desire for personalisation of products and services: cultural antecedents and consequences for customer evaluations. total quality management and business excellence activate this "bracelet of silence," and alexa can"t eavesdrop. the new york times consumer and object experience in the internet of things: an assemblage theory approach demystifying customer brand engagement: exploring the loyalty nexus engagement-facilitating technology and stakeholder wellbeing, call for special issue consumer brand engagement in social media: conceptualization, scale development and validation problematic smartphone usage and subjective and psychological well-being putting the "app" in happiness: a randomised controlled trial of a smartphone-based mindfulness intervention to enhance wellbeing an empirical examination of consumer adoption of internet of things services: network externalities and concern for information privacy perspectives cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives mediation analysis customer engagement in the service context: an empirical investigation of the construct, its antecedents and consequences personality factors as predictors of online consumer engagement: an empirical investigation the role of customer engagement behavior in value co-creation: a service system perspective the role of internet self-efficacy, innovativeness and technology avoidance in breadth of internet use: comparing older technology experts and non-experts smart service experience in hospitality and tourism services: a conceptualization and future research agenda digital marketing: a framework, review and research agenda barriers to smart services for manufacturing companies -an exploratory study in the capital goods industry outsourcing the pain, keeping the pleasure: effects of outsourced touchpoints in the customer journey within-person variation in security of attachment: a self-determination theory perspective on attachment, need fulfillment, and well-being the internet of everything: smart things and their impact on business models modeling heterogeneity in the satisfaction, loyalty intention, and shareholder value linkage: a cross-industry analysis at the customer and firm levels companionship with smart home devices: the impact of social connectedness and interaction types on perceived social support and companionship in smart homes data-driven understanding of accounting for common method variance in crosssectional research designs the antecedents of consumers" negative attitudes j o u r n a l p r e -p r o o f toward sms advertising: a theoretical framework and empirical study common method variance in is research: a comparison of alternative approaches and a reanalysis of past research drivers of consumers" resistance to smart products consumer resistance to innovation in services: challenges and barriers in the internet of things era how gifts influence relationships with service customers and financial outcomes for firms technological forecasting & social change a systematic review of the smart home literature: a user perspective smartening up with artificial intelligence (ai) -what"s in it for germany and its industrial sector? coproduction of transformative services as a pathway to improved consumer well-being: findings from a longitudinal study on financial counseling choosing among alternative service delivery modes: an investigation of customer trial of self-service technologies internet of things: vision, applications and research challenges the uncanny valley. energy bayesian analysis in mplus: a brief introduction scaling procedures: issues and applications the internet-of-things: review and research directions why can't we be separated from our smartphones? the vital roles of smartphone activity in smartphone separation anxiety baby boom consumers and technology: shooting down stereotypes relationship journeys in the internet of things: a new framework for understanding interactions between consumers and smart objects service research priorities in a rapidly changing context customer engagement: the construct, antecedents, and consequences running experiments on amazon mechanical turk e-health and wellbeing monitoring using smart healthcare devices: an empirical investigation common method biases in behavioral research: a critical review of the literature and recommended remedies smart, connected products are transforming competition consumer evaluations of autonomous domestic products how today"s consumers perceive tomorrow"s smart products product intelligence: its conceptualization, measurement and impact on consumer satisfaction connecting alone: smartphone use, quality of social interactions and well-being predictors of customer acceptance of and resistance to smart technologies in the retail sector constituents and consequences of smart customer experience in retailing customer engagement behaviors: the role of service convenience, fairness and quality measuring and forecasting mobile game app engagement self-determination theory and the facilitation of intrinsic motivation, social development, and well-being on happiness and human potentials: a review of research on hedonic and eudaimonic well-being servant, friend or master? the relationships users build with voice-controlled smart devices to be or not to be in thrall to the march of smart products brandscapes: contrasting corporate-generated versus consumer-generated media in the creation of brand meaning is personalization of services always a good thing? exploring the role of technology-mediated personalization (tmp) in service relationships effects of computer training and internet usage on cognitive abilities in older adults: a randomized controlled study smart home device sales worldwide - connecto ergo sum! an exploratory study of the motivations behind the usage of connected objects aligning the mindset and capabilities within a business network for successful adoption of smart services customization of online advertising: the role of intrusiveness customer engagement behavior: theoretical foundations and research directions engaging the unengaged customer: the value of a retailer mobile app service recovery"s impact on customers next-in-line consumer connectivity in a complex, technology-enabled, and mobile-oriented world with smart products managing engagement behaviors in a network of customers and stakeholders: evidence from the nursing home sector unhappy and addicted to your phone? -higher mobile phone use is associated with lower well-being the privacy trade-off for mobile app downloads: the roles of app value, intrusiveness, and privacy concerns futurizing" smart service: implications for service researchers and managers high tech and high touch: a framework for understanding user attitudes and behavors related to smart interactive services the personalization privacy paradox: an exploratory study of decision making process for location-aware marketing the moderating role of consumer technology anxiety in mobile shopping adoption: differential effects of facilitating conditions and social influences strategic change implementation and performance loss in the front lines the impact of employee satisfaction on quality and profitability in high-contact service industries bayesian mediation analysis three decades of customer value research: paradigmatic roots and future research avenues reconsidering baron and kenny: myths and truths about mediation analysis factor loading factor loading smartness characteristics (adapted from rijsdijk et al., ; rijsdijk & hultink, ) awareness (cr = . ; ave = . ; cr.α = . ) . this smart fridge keeps an eye on itself and its environment. key: cord- -r xkpwte authors: keeble, matthew; adams, jean; sacks, gary; vanderlee, lana; white, christine m.; hammond, david; burgoine, thomas title: use of online food delivery services to order food prepared away-from-home and associated sociodemographic characteristics: a cross-sectional, multi-country analysis date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: r xkpwte online food delivery services like just eat and grubhub facilitate online ordering and home delivery of food prepared away-from-home. it is poorly understood how these services are used and by whom. this study investigated the prevalence of online food delivery service use and sociodemographic characteristics of customers, in and across australia, canada, mexico, the uk, and the usa. we analyzed online survey data (n = , ) from the international food policy study, conducted in . we identified respondents who reported any online food delivery service use in the past days and calculated the frequency of use and number of meals ordered. we investigated whether odds of any online food delivery service use in the past days differed by sociodemographic characteristics using adjusted logistic regression. overall, % of respondents (n = ) reported online food delivery service use, with the greatest prevalence amongst respondents in mexico (n = ( %)). online food delivery services had most frequently been used once and the median number of meals purchased through this mode of order was two. odds of any online food delivery service use were lower per additional year of age (or: . ; % ci: . , . ) and greater for respondents who were male (or: . ; % ci: . , . ), that identified with an ethnic minority (or: . ; % ci: . , . ), were highly educated (or: . ; % ci: . , . ), or living with children (or: . ; % ci: . , . ). further research is required to explore how online food delivery services may influence diet and health. according to global estimates from , % of men and % of women were living with obesity, which has been associated with multiple co-morbidities [ , ] . whilst the drivers of obesity are complex, the role of excess calorie intake through consumption of food prepared away-from-home has been recognized in previous research [ ] [ ] [ ] . food prepared away-from-home is often energy dense, high in fat and salt, and less healthy than food prepared at home, and more frequent consumption has been associated with elevated bodyweight [ ] [ ] [ ] [ ] [ ] . food prepared away-from-home is typically served ready to consume and has become a major contributor to overall dietary intake [ , ] . in the usa, for example, food prepared away-from-home accounted for over % of total food expenditure in [ ] . traditionally, this food may have been purchased through 'conventional' modes of order whereby customers would visit food outlets in-person or contact food outlets directly to place orders before collection or delivery. third-party platforms that facilitate online ordering and delivery, referred to throughout as 'online food delivery services', provide an alternative mode of order that appears to have grown in popularity [ ] . whilst business models vary, online food delivery services typically operate as intermediaries between customers and food outlets [ ] . customers place orders through online platforms, their orders are forwarded to food outlets where meals are cooked, and once ready, meals are delivered to customers by couriers working for the food outlet or the online food delivery service [ , ] . in , prominent online food delivery services just eat (including subsidiaries) and uber eats, were available in countries, deliveroo was available in countries, and grubhub was established in many cities across the usa [ ] [ ] [ ] [ ] . online food delivery service availability has been forecast to increase, which could lead to greater use. in turn, this could increase the purchase and consumption of food prepared away-from-home [ ] . to our knowledge, there is currently a limited understanding about the nutritional quality of food items sold through online food delivery services. nonetheless, given that food sold through online food delivery services is primarily prepared in existing food outlet facilities [ ] , it may have a similar nutrient profile to food prepared away-from-home ordered in conventional ways. as such, online food delivery services could contribute to excess calorie intake and adverse health outcomes [ , , ] . accordingly, interventions to reduce online food delivery service use or to improve the nutritional quality of food that is available, may be called for in the future. previous research into online food delivery services is limited. a narrative review identified business reports stating that convenience and choice of food outlet were potential drivers of online food delivery service use, supporting findings from malaysia and indonesia [ , ] . a further study investigated the availability of food outlets through an online food delivery service in one city in each of australia, the netherlands, and the usa [ ] . in each city, a diverse range of food types were available and the number of food outlets that were available differed by area level deprivation. to date, the prevalence and frequency of online food delivery service use and the sociodemographic characteristics of online food delivery service customers have not been investigated, and thus remain poorly understood. understanding how often online food delivery services are used and the sociodemographic characteristics of current online food delivery service customers will establish a baseline against which future use can be compared, allow any future interventions to be targeted towards frequent users, serve as an indicator of potential public health harm and of the need for further research. in this study, we aimed to describe the prevalence and frequency of online food delivery service use, investigate associations between online food delivery service use and sociodemographic characteristics, and describe how online food delivery service customers used other modes of order to purchase food prepared away-from-home, in and across five upper-middle or high-income countries. we used cross-sectional data from the international food policy study (ifps), conducted in australia, canada, mexico, the uk, and the usa in november . data collection methods have been described elsewhere [ ] . briefly, data were collected via self-completed online surveys from adults aged years or over, recruited through nielsen consumer insights global panel and their partners' panels. panelists were screened for eligibility and quota requirements based on device screen size, age, and sex. email invitations containing links to an online survey in national languages were sent to a random sample of eligible panelists in each country. respondents provided consent prior to survey completion. the ifps was reviewed by and received ethics clearance through a university of waterloo research ethics committee (ore# ). all respondents were asked: "during the past days, how many meals did you get that were prepared away-from-home in places such as restaurants, fast food or takeaway places, food stands, or from vending machines?". a similar question has been asked in previous research [ , ] . respondents who had purchased at least one meal prepared away-from-home reported the number of meals ordered: "using a food delivery service (e.g. country specific examples) and delivered", "directly from a restaurant and delivered", "at a restaurant/food outlet within minutes of your home", and "at a restaurant/food outlet more than minutes away from your home". country-specific examples of online food delivery services available in each country included uber eats (all countries), just eat (canada, mexico, uk), deliveroo (australia, uk), foodora (australia), skipthedishes (canada), and grubhub (usa). in our analyses, we collapsed "at a restaurant/food outlet within minutes of your home" and "at a restaurant/food outlet more than minutes away from your home" into a single category: 'directly from food outlets in-person'. we included sex, age, ethnicity, education, body mass index (bmi), and living with children aged under years as independent variables. age was reported in years (continuous). ethnicity was reported as the group that best described racial or ethnic backgrounds. we dichotomized responses into 'majority' (white, predominantly english speaking or not indigenous) and 'minority' (all other responses). education was reported as the highest level completed. we categorized respondents as having: 'low' (high school completion or lower), 'medium' (some post-high school qualifications), or 'high' (university degree or higher) levels of education, and used this variable as a marker of socioeconomic status [ ] . height and weight were reported in either metric or imperial units. we calculated bmi (kg/m ) and grouped respondents by world health organization categories: 'underweight' (bmi < . ), 'normal weight' (bmi . - . ), 'overweight' (bmi . - . ), or 'obesity' (bmi ≥ ) [ ] . we collapsed the 'underweight' and 'normal weight' categories into a 'not overweight' category (bmi < . ), and as individuals with greater bmi may not always report their height and weight, we included respondents with missing data for this variable and categorized them as 'missing' [ , ] . living with children aged under years was reported as a binary variable. in total, , respondents completed the online survey. we excluded respondents with missing data for variables of interest (except for bmi), when the total number of meals purchased away-from-home and the number of meals purchased through each mode of order summed did not match, or when the total number of meals purchased away-from-home in the past days exceeded (n = ). we considered to be the maximum number of meals that could be purchased away-from-home based on daily consumption of three meals in the past days. the final analytical sample included , respondents. to reduce non-response and selection bias, we applied post-stratification sample weights. weights were constructed using population estimates from the census in each country based on age, sex, region, ethnicity (except in canada) and education (except in mexico) [ , ] . in each country, we determined the prevalence of online food delivery service use by identifying respondents who reported that they had used an online food delivery service at least once in the past days. for these 'online food delivery service customers' we identified the frequency of online food delivery service use and calculated the number and proportion of all meals purchased away-from-home for each mode of order ('online food delivery services', 'directly from food outlets for delivery' and 'directly from food outlets in-person'). for respondents who had purchased at least one meal prepared away-from-home directly from food outlets for delivery or in-person but had not used an online food delivery service ('non-online food delivery service customers'), we calculated the number and proportion of all meals purchased away-from-home 'directly from food outlets for delivery' and 'directly from food outlets in-person'. in analyses, we used online food delivery service use as our dependent variable. as data were not normally distributed, we dichotomized respondents into any online food delivery service use in the past days or not. we used pearson's χ to compare differences in sociodemographic characteristics of online food delivery service customers in each country. to investigate associations between our dependent variable and sex, age, ethnicity, education, bmi, and living with children aged under years, across all countries combined, we used logistic regression following a sequential modelling strategy. model was unadjusted, model was adjusted for all independent variables except education, to investigate variation by individual-level socioeconomic status, and model was maximally adjusted [ , ] . to investigate differences in online food delivery service use between countries, we used separate, maximally adjusted, logistic regression models with each country as the reference category. we investigated differences in prevalence of online food delivery service use and independent variables between countries by adding a two-way interaction term (country x independent variable) to separate maximally adjusted logistic regression models and used post-estimation wald tests to determine interaction term significance. when interaction terms were significant, we stratified analyses by country. we used stata version . (statacorp llc., college station, tx, usa) to complete analyses in , with a significance threshold of p < . used throughout. amongst our sample, % (n = , ) had purchased at least one meal prepared away-from-home in the past days; % (n = ) had used an online food delivery service at least once, and % (n = , ) had purchased food prepared away-from-home directly from food outlets for delivery or in-person, but had not used an online food delivery service. overall, more than half of our sample were female or identified with an ethnic majority, most had low education, over % were living with obesity, the median age was years, and less than % lived with children aged under years (supplementary material: table s ). overall, more than half of the online food delivery service customers were male, identified with an ethnic majority, were highly educated, or were living with children aged under years, while around % were living with overweight or obesity, and the median age was years (table ) . sociodemographic characteristics of respondents that had purchased at least one meal prepared away-from-home directly from food outlets for delivery or in-person, but had not used an online food delivery service (n = , ), are shown in supplementary material (table s ) . around half of respondents that reported any online food delivery service use in the past days, had used this mode of order once (supplementary material: figure s ). table reports the modes of order used to purchase meals prepared away-from-home. overall, online food delivery service customers ordered a median of two meals prepared away-from-home through an online food delivery service, which represented % of all meals purchased away-from-home. online food delivery service customers also ordered a median of one meal directly from food outlets for delivery and two meals directly from food outlets in-person. overall, the median number of meals that non-online food delivery service customers ordered directly from food outlets for delivery was two, which was the same as the median number of meals ordered directly from food outlets in-person. note: a -unless specified, data reported as n (%). b -p values from pearson's χ test. c -online food delivery service customers had purchased at least one meal prepared away-from-home through an online food delivery service in the past days. table . modes of order used in the past days to purchase meals prepared away-from-home. note: a -p value from pearson's χ test. b -online food delivery service customers had purchased at least one meal prepared away-from-home through an online food delivery service in the past days. c -data reported as median (interquartile range (iqr)) number of meals, and median (iqr) proportion of all meals purchased away-from-home, per person. d -non-online food delivery service customers had purchased at least one meal prepared away-from-home directly from food outlets but not through an online food delivery service, in the past days. sociodemographic correlates of any online food delivery service use in the past days from unadjusted and partially adjusted models are reported in supplementary material (table s ). figure reports findings from the maximally adjusted model. overall, there were greater odds of online food delivery service use amongst respondents who were male (or: . ; % ci: . figure . associations between prevalence of any online food delivery service use in the past days and sociodemographic characteristics (n = , ). data are from , collected through the international food policy study, analyzed using adjusted logistic regression a . note: a -reference groups: ethnicity-majority, education level-low, body mass index (bmi) category-not overweight. the greatest prevalence of any online food delivery service use in the past days was amongst respondents in mexico (n = ( %)). respondents in canada had lower odds of online food delivery service use compared to respondents in all other countries, whilst respondents in the uk and mexico had greater odds compared to respondents in all other countries (table ) . amongst online food delivery service customers in australia, mexico, and the usa, the median number of meals ordered through online food delivery services per person, was two, whereas in canada and the uk, the median number, per person, was one ( table ) . there were significant between-country interactions. the association between online food delivery service use in the past days and each of age (p < . ), living with children aged under years (p = . ), sex (p < . ), and education (p < . ) varied between countries (supplementary material: table s ). the greatest prevalence of any online food delivery service use in the past days was amongst respondents in mexico (n = ( %)). respondents in canada had lower odds of online food delivery service use compared to respondents in all other countries, whilst respondents in the uk and mexico had greater odds compared to respondents in all other countries (table ) . amongst online food delivery service customers in australia, mexico, and the usa, the median number of meals ordered through online food delivery services per person, was two, whereas in canada and the uk, the median number, per person, was one ( table ) . there were significant between-country interactions. the association between online food delivery service use in the past days and each of age (p < . ), living with children aged under years (p = . ), sex (p < . ), and education (p < . ) varied between countries (supplementary material: table s ). figures - report country-stratified findings. odds of online food delivery service use in the past days were lower per additional year of age amongst respondents in all countries. respondents who lived with children aged under years had greater odds of online food delivery service use in all countries, with the strongest association observed amongst respondents in the usa (or: . ; % ci: . , . ) . there was no difference in odds of online food delivery service use by sex amongst respondents in mexico (or: . ; % ci: . , . ), whereas males in all other countries had greater odds of online food delivery service use. respondents with high (versus low) levels of education had greater odds of online food delivery service use in all countries except the uk (or: . ; % ci: . , . ). to our knowledge, this is the first study in the published international literature that has examined the prevalence and frequency of online food delivery service use and identified sociodemographic characteristics of online food delivery service customers. our findings from multiple countries provide knowledge about the individual and wider contextual factors that may relate to online food delivery service use. overall, % of respondents across australia, canada, mexico, the uk, and the usa reported online food delivery service use in the past days, however, almost two thirds of respondents had purchased food prepared away-from-home directly from food outlets but had not used an online food delivery service. online food delivery services were most frequently used once in the past days. overall, online food delivery service customers ordered a median of two meals through an online food delivery service, and the median proportion of all meals purchased away-from-home ordered through an online food delivery service was more than %. respondents who were male, younger, with higher education, lived with children aged under years, or that identified with an ethnic minority had greater odds of online food delivery service use. respondents in mexico and the uk had greater odds of online food delivery service use compared to respondents in other countries, and whilst correlates of online food delivery service use were similar in each country, the strength of associations varied. as the first study to investigate the prevalence and frequency of online food delivery service use in and across multiple countries, we are unable to conclude that the levels we identified are relatively high or low. nonetheless, our findings regarding the modes of order used to purchase food prepared away-from-home provide novel insight into how multiple ways of purchasing food prepared away-from-home may coexist. when having food delivered, those who reported any online food delivery service use in the past days appeared to favor this mode of order compared to ordering directly from food outlets. our observation could support the suggestion that online food delivery services have the capacity to disrupt conventional and established purchasing formats within food retail, which in turn, could influence how individuals interact with the built food environment [ ] . however, a high proportion of online food delivery service customers reported that they also visited food outlets in-person, indicating that the traditional practice of visiting neighborhood food outlets persisted regardless of online food delivery service use. therefore, promotion of healthier neighborhood food environments, for example through the use of urban planning or 'zoning' continues to be a potentially effective public health intervention [ ] . importantly, using multiple modes of order to purchase food prepared away-from-home may lead to greater total consumption, increased risk of excess weight and adverse health outcomes [ , ] . the full extent to which using multiple modes of order, and in-particular online food delivery service use, increases consumption of food prepared away-from-home, is unclear without longitudinal data. consistent with our finding that men had greater odds of online food delivery service use, men reportedly purchase food prepared away-from-home more frequently and cook at home less than women [ , ] . it is unclear how reasons for purchasing food prepared away-from-home might differ based on mode of order used, and how these reasons may vary by sex. respondents that identified with an ethnic minority had greater odds of online food delivery service use. analyses of data from the national health and nutrition examination survey completed in the usa indicated that black respondents cooked at home less frequently than other groups [ ] . however, further research from the usa [ ] and uk [ ] concluded that individuals that identified with an ethnic minority allocated more time to home food preparation and consumed more home cooked food than individuals that identified with an ethnic majority. online food delivery service use could reduce home cooking, which might have implications for the overall diet quality of customers. whilst it is possible to meet dietary guidelines through consumption of food prepared away-from-home, it may be more difficult and more expensive than through food prepared at home [ , ] , and bound by the types of food outlet available [ ] . in our study, online food delivery service customers were likely to be younger, have higher education, or live with children aged under years. similarly, marketing companies and online food delivery services suggest that individuals with these sociodemographic characteristics often report online food delivery service use [ ] . older individuals may be disinclined to order food online due to lacking familiarity with technology and a loyalty towards conventional modes of order, whilst individuals who are younger, highly educated, or parents, often report having limited time and may purchase food prepared away-from-home to offset pressure stemming from having limited time resources [ ] [ ] [ ] [ ] . as previously described, reasons for using one mode of order over another are currently unclear [ ] . future research should engage with online food delivery service customers to better understand their reasons for online food delivery service use. analysis of the uk's national diet and nutrition survey identified that living with obesity was associated with greater consumption of food from fast-food outlets but not restaurants or cafés [ ] . in our study, online food delivery service use was not associated with weight status. to some extent, this may be due to our cross-sectional study design and the simultaneous measurement of our exposure (online food delivery use) and outcome (weight status). however, it is also possible that this reflects the potential for online food delivery services to offer food from different types of food outlets, including restaurants, which may offer healthier food than is traditionally served away-from-home [ ] . in our analysis it was not possible to disaggregate online delivery service use by the type of food outlet that meals were ordered from. future research investigating which food outlets are ordered from when using online food delivery services, and the nutritional composition of foods sold, would provide greater insight into associations between food delivery service use and weight status. this understanding would serve to inform the need for development of public health interventions. the prevalence of online food delivery service use, the proportion of all meals prepared away-from-home purchased through online food delivery services, and the number of meals purchased directly from food outlets in-person by non-online food delivery service customers, were each greatest for respondents in mexico. together, these findings may reflect cultural norms aligned with frequent purchase of food prepared away-from-home in this country [ ] . individuals with greater access to food outlets through online food delivery services could be inclined to use them more frequently. this may explain plans from just eat, branded as skipthedishes, to increase the number of food outlets in canada who are signed up to accept orders through their platform [ ] . indeed, our finding that respondents from canada had lower odds of online food delivery service use compared to respondents in all other countries could indicate that there is currently limited access to food outlets through this mode of order. future research could investigate the extent to which access to food outlets signed up to accept orders through online food delivery services is associated with online food delivery service use. sociodemographic characteristics of online food delivery service customers were similar between countries, however, the strength of associations varied. notably, higher education was associated with greater odds of online food delivery service use in all countries except the uk. food outlets signed up to accept orders through online food delivery services in the uk may not sell food that accommodates the needs of individuals with higher education, possibly limiting use. the type of food available through online food delivery services in the uk is currently unclear. whilst the uk may be different, amongst food outlets signed up to accept orders through an online food delivery service in australia, the netherlands, and the usa, common food labels used to describe the type of food sold included 'burgers', 'pizza', and 'italian', with 'healthy' food labels less common [ ] . however, labels selected by food outlets may not always reflect the food they sell and the nutritional quality of food available through online food delivery services remains unclear. given the apparent lack of 'healthy' food choices, further work to develop an understanding about how well self-selected labels reflect the types of food that outlets sell, and the nutritional quality of this food, is warranted. this study represents the most comprehensive description of online food delivery service use to date. nonetheless, the findings are subject to limitations, including those common to survey-based research. respondents were recruited using nonprobability-based sampling. thus, findings are not necessarily nationally representative. we applied post-stratification sample weights to improve representativeness, yet respondents in mexico had higher levels of education than census estimates and average bmi scores were lower than national averages for respondents in all countries [ ] . recruitment may have been biased towards individuals with internet access. in , however, internet penetration rates ranged between % (mexico) and % (australia), with rates of % or higher in canada, the uk, and the usa [ ] . analyses were based on cross-sectional data, limiting the ability to draw causal inference. additionally, data were self-reported and collected through online surveys. social desirability bias may have led to the number of meals purchased away-from-home, online food delivery service use, and body weight being under-reported. this risk may have been reduced by use of online surveys that offer respondents a sense of anonymity when reporting sensitive information [ , ] . finally, we used education as our marker of socioeconomic status which may not be internationally comparable [ , ] . it is possible that the global covid- pandemic has accelerated changes in consumer behavior with regards to use of online modes of order [ ] . at least in terms of the research contexts studied here, individuals that may have previously visited food outlets in-person to purchase food prepared away-from-home are likely to have found that this option has been restricted, and may therefore have adopted online modes of order. whilst there is much uncertainty, it is possible that short-term changes in consumer behavior persist long term. research is required to fully understand short-and long-term changes in online food delivery service and in-person food outlet use. we found that % of adults across australia, canada, mexico, the uk, and the usa had purchased food prepared away-from-home through online food delivery services in the past days. online food delivery service use was associated with being male, from an ethnic minority, younger, highly educated, or living with children aged under years. sociodemographic characteristics of online food delivery service customers were consistent across countries, yet there was variation in the strength of associations. norms surrounding the purchase of food prepared away-from-home, stressors on time that limit the opportunity for home meal preparation, and the number and type of food outlets that can be accessed through online food delivery services may vary internationally and could help explain observed differences between countries. whilst we identified sociodemographic characteristics of online food delivery service customers, which is important information for future intervention development, further research is needed to understand the extent to which use of an online food delivery service contributes to overall purchasing and consumption of food prepared away-from-home, whether online food delivery services are used in place of, or in addition to, traditional modes of order, and associated implications for public health. supplementary materials: the following are available online at http://www.mdpi.com/ - / / / /s , table s : sociodemographic characteristics of analytic sample, table s : sociodemographic characteristics of non-online food delivery service customers, figure s : frequency of online food delivery service use in the past days amongst online food delivery service customers, table s : associations between prevalence of any online food delivery service use in the past days and sociodemographic characteristics, table s : odds ratio (or) and % confidence intervals (cis) from two-way interaction term added to separate, maximally adjusted, logistic regression models. fast-food restaurant, unhealthy eating, and childhood obesity: a systematic review and meta-analysis world health organization. global health observatory (gho) data dietary quality among men and women in countries in and : a systematic assessment implications of the foresight obesity system map for solutions to childhood obesity the single most important intervention to tackle obesity determination of salt content in hot takeaway meals in the united kingdom nutritional composition of takeaway food in the uk eating out of home and its association with dietary intake: a systematic review of the evidence restaurant menus: calories, caloric density, and serving size the impact of food away from home on adult diet quality global nutrition transition and the pandemic of obesity in developing countries interplay of socioeconomic status and supermarket distance is associated with excess obesity risk: a uk cross-sectional study food prices and spending how we eat determines what we become: opportunities and challenges brought by food delivery industry in a changing world in china an analysis of online shopping and home delivery in the uk consumer experiences, attitude and behavioral intention toward online food delivery (ofd) services uber eats. when and where is uber eats available? available online half year results what is grubhub? available online online food delivery report over)eating out at major uk restaurant chains: observational study of energy content of main meals loyalty toward online food delivery service: the role of e-service quality and food quality international food policy study away from home meals: associations with biomarkers of chronic disease and dietary intake in american adults food sources among young people in five major canadian cities diet and socioeconomic position: does the use of different indicators matter? world health organization missing data and multiple imputation in clinical epidemiological research faking it: social desirability response bias in self-report research techniques for handling missing data in secondary analyses of large surveys understanding logistic regression analysis modeling and variable selection in epidemiologic analysis delivery the disruptor how does local government use the planning system to regulate hot food takeaway outlets? a census of current practice in england using document review fast-food habits, weight gain, and insulin resistance (the cardia study): -year prospective analysis food delivery and takeaway market in the united kingdom (uk)-statistics & facts socio-economic differences in takeaway food consumption among adults. public health nutr sociodemographic characteristics and frequency of consuming home-cooked meals and meals from out-of-home sources: cross-sectional analysis of a population-based cohort study prevalence and patterns of cooking dinner at home in the usa: national health and nutrition examination survey (nhanes) who's cooking? trends in us home food preparation by gender comparison of individuals with low versus high consumption of home-prepared food in a group with universally high dietary quality: a cross-sectional analysis of the uk national diet & nutrition survey neighborhood prices of healthier and unhealthier foods and associations with diet quality: evidence from the multi-ethnic study of atherosclerosis food shopping and acquisition behaviors in relation to bmi among residents of low-income communities in south carolina a narrative review of online food delivery in australia: challenges and opportunities for public health nutrition policy. public health nutr. , - , (epub ahead of print) a review of technology acceptance by older adults time scarcity and food choices: an overview ready-made" assumptions: situating convenience as care in the australian obesity debate socioeconomic disadvantage and the purchase of takeaway food: a multilevel analysis why eat at fast-food restaurants: reported reasons among frequent consumers utilization of away-from-home food establishments, dietary approaches to stop hypertension dietary pattern, and obesity nutrition transition in mexico and in other latin american countries a cross-sectional comparison of meal delivery options in three international cities internet penetration rates are high in north america determinants of social desirability bias in sensitive surveys: a literature review analysis of the over uk national diet and nutrition survey indicators of socioeconomic position (part ) covid- : impact on the urban food retail system, diet and health inequalities in the uk the authors thank the participants from wave two of the international food policy study. the authors declare no conflict of interest. key: cord- -bp sray authors: hu, guangyu; han, xueyan; zhou, huixuan; liu, yuanli title: public perception on healthcare services: evidence from social media platforms in china date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: bp sray social media has been used as data resource in a growing number of health-related research. the objectives of this study were to identify content volume and sentiment polarity of social media records relevant to healthcare services in china. a list of the key words of healthcare services were used to extract data from wechat and qzone, between june and september . the data were put into a corpus, where content analyses were performed using tencent natural language processing (nlp). the final corpus contained approximately million records. records on patient safety were the most frequently mentioned topic (approximately . million, . % of the corpus), with the contents on humanistic care having received the least social media references ( . million, . %). sentiment analyses showed . %, . %, and . % of positive, neutral, and negative emotions, respectively. the doctor-patient relationship category had the highest proportion of negative contents ( . %), followed by service efficiency ( . %), and nursing service ( . %). neutral disposition was found to be the highest ( . %) in the contents on appointment-booking services. this study added evidence to the magnitude and direction of public perceptions on healthcare services in china’s hospital and pointed to the possibility of monitoring healthcare service improvement, using readily available data in social media. investigating public perception of healthcare services from different perspectives may generate inconsistent results. for example, patient-initiated violence against health workers [ ] [ ] [ ] [ ] [ ] [ ] , and the tension between doctors and patients for their dissatisfaction with the quality of healthcare [ , ] , were wildly covered in the chinese media. while patient experience surveys on the national level showed that patients were generally satisfied with both in-patient and out-patient services [ ] . such differences may result from biases rooted in the survey and media coverage; however, the inconsistency also pointed to the need for additional data sources to monitor public opinions on chinese healthcare services. it has been suggested that social media might be such a data source. rozenblum et al. pointed out that when patient-centered healthcare, the internet, and social media were combined, the current relationship between healthcare providers and consumers might face major changes-thus creating a "perfect storm" [ ] . users' posts on the social media platforms would generate a large volume of real-time data regarding public or private issues, among which healthcare related information scatters. therefore, the utilization of social media data for healthcare research becomes a dramatically growing field and already covered various medical and healthcare research fields [ , ] . sinnenberg and colleagues proposed four ways in which social media data were used in healthcare studies: ( ) content analysis, ( ) volume surveillance of contents on specific topics, ( ) engagement of users with others, and ( ) network analysis of users [ ] . for the content analysis, most studies focused on measuring public discussion on specific diseases [ ] [ ] [ ] , sentiment analysis for medical interventions (e.g., cancer screening) [ , ] , identifying safety concerns among health consumers [ ] , detecting adverse events of health products [ , ] . several researchers studied patient experience, based on the comments posted by patients from online health communities in china [ , ] , but few studies have been conducted to gather information on healthcare services related topics using social media data. meanwhile, although sentiment analysis has been wildly applied to process user sentiments associated with health-related text [ ] , the lexical resource and tools designed for doing health-related sentiment analysis in chinese language are few and far between. fast-advancing in technology and economy, social media users and their activities spiked in china, which made social media a promising source for healthcare service monitoring. in china, the internet penetration rate reached . % at the end of [ ] , with local providers dominating the market, rather than facebook and twitter, which are not accessible in china. chinese social media sites have a unique landscape, and it may not only be used as a communication software but also as an entry point for information. as subsidiaries of tencent holdings limited, shenzhen, china, wechat and qzone are two leading social media and networking services platforms. each of them reached more than million and million monthly active user accounts in the first quarter of [ ] . according to the wechat data report, typical users of wechat were born in the s or s [ ], representing a wide breadth of demographic group in china. besides providing multimedia communication and supporting social networking, wechat also has "official accounts", which serve as channels for publishing articles to the public. any individual or organization can apply for having their own official account to broadcast their ideas and believes. as for qzone, it is a platform bundled with qq, a popular online messaging application in china. qzone allows users to create their own personal page to write blogs and post updates. and users could be able to express their individual opinions and attitudes freely and instantly on the social media platforms. subject to the platforms' terms of service and privacy policy agreed upon by users [ , ] , three kinds of information were collected, stored, and used by the platforms: ( ) personal information; ( ) non-personal information; and ( ) shared information. the shared information refers to information that is voluntarily shared on the platforms by users freely and instantly, thus providing a valuable perspective and opportunity to gather public opinions on healthcare services. as such, we selected wechat and qzone as the social media platforms to conduct this exploratory study. the objectives of this study are to conduct volume and sentiment analyses base on the extracted social media contents on hospital healthcare services. the study could demonstrate the social media users' perceptions of hospitals healthcare and may shed light on the further utilization of social media as a data source for healthcare research in china. this study consisted of three phases. firstly, we utilized a predefined list of healthcare services categories to devise key words and search strategies accordingly. the data searching strategy would then be used to extract contents from a raw database, which contained publicized posts of wechat and qzone. the extracted materials were then put into a corpus. secondly, we applied natural language processing (nlp) techniques from tencent nlp platform to the corpus and calculated the volume of content concerning different healthcare services topics. thirdly, we conducted sentiment analysis to explore the sentiment polarity of chinese social media users on different healthcare service topics. the detailed process of data collection and analysis is presented in figure the raw databases used for this study come from wechat and qzone of the version only operated in mainland china. the user volumes and data inclusion criteria of the platforms were showed in table . publicly available posted information such as: posted blogs, reviews and articles that are voluntarily shared by individual users from june to september were collected from the two platforms. the data collection followed the privacy policy for users of tencent and was subject to the confidentiality and security measures that implemented by the platforms. and the data analyses were supported by technicians in the tencent. the nine healthcare service categories, used in this study, were derived from the objectives of the national healthcare service improvement initiative ( - ), which was dedicated to improving patient-centered healthcare and patient experience nationwide by the former national health and family planning commission of p.r. china (nhfpc) [ ] . the initiative operated under the leadership of the bureau of medical administration of nhfpc [ ] , which suggested that we used nine predefined categories to reflect the healthcare services in hospital (see table ). table . healthcare services categories and corresponding descriptions in the national healthcare service improvement initiative - (nhsii). objectives of nhsii optimize the layout of the facility and build a friendly service environment appointment-booking service promote utilization of clinical appointment services and guide patient flow service efficiency improve service efficiency and effectiveness by rational allocation of resources information technology take advantage of information technology to improve patient experience inpatient service promote inpatient service process reengineering and provide integrated healthcare service nursing service continuously improve quality of nursing care and enhance nursing workforce patient safety ensure patient safety by promoting adoption of standard operating procedures humanistic care strengthen humanistic care and provide medical social worker service doctor-patient relationship harmonize the doctor-patient relationship and reduce medical disputes in this study, we constructed a healthcare services corpus, in the chinese language from the social media data source, to enable further analyses. first, we constructed lexica of keywords and terms in accordance with the predefined service topics. for example, the lexicon for "information technology", used in this study indicate new information dissemination channels, based on information technology provided by hospital to improve patient experience of service information acquisition. and this lexicon contains six information technology service-related terms, namely, "weibo", "wechat", "website", as well as "self-service machine". second, we developed a set of searching strategy to extract the relevant data from the two sources based on the corresponding lexicon of topics. the entire list of search terms for each category and its corresponding searching strategy were provided in supplementary table s . finally, we applied the search strategies to the database of publicly posted materials to screen for posts related to the healthcare service categories to construct the corpus. the search and screening process were performed by qcloud. based on the healthcare services corpus, we classified the content to different healthcare services topics that predefined and measured the content volume of the topic. specifically, we used the open application programming interface (openapi) services provided by tencent nlp to analyze the retrieved contents. it is an open platform for chinese natural language processing (based on parallel computing and distributed crawling system) [ ] . such services enable us to split reviews and blogs into sentences, and each sentence was filtered to classify whether it contained target service topic keywords and terms. if the sentences, containing certain keywords and terms, belonged to the corresponding topic of healthcare services categories as listed in table s , then they would be divided into a certain category. by counting the appearances of each service topic keywords in terms of the number of sentences in the corpus, we can aggregate the counts at the topic level and calculate the proportion of different topics from the social media corpus. for the sentiment analysis tool in chinese, we also select tencent nlp, as its algorithm was trained by hundreds of billions of entries of internet corpus data in chinese and with successful application in other tencent products (https://nlp.qq.com). openapi with function of chinese batch texts automatic summarization and sentiment analysis of tencent nlp enable us to categorize the sentences on certain topic in the social media corpus into a sentiment polarity classification (i.e., neutral, positive, and negative). finally, each sentence was tagged and classified into different sentiment polarity. the social media corpus contained approximately million records from wechat and qzone, spanning the pre-defined categories, related to hospital healthcare services. table presents the content volume of each healthcare services topic by social media channel. among the social media content on healthcare services topics, patient safety was the most commonly encountered topic, both in wechat and qzone. the majority of the content related to patient safety issue, its approximately . million records and covered . % of the entire corpus. the proportion of contents related to other topics varied in the corpus: information technology ( . %), service efficiency ( . %), service environment ( . %), inpatient service ( . %), appointment-booking service ( . %), nursing service ( . %), doctor-patient relationship ( . %), and humanistic care ( . %). the results of the sentiment analysis of contents from the corpus found that, in all nine healthcare services topics, . % of the contents in the corpus have been recognized to reveal a positive disposition, . % neutral and . % negative. we found that topic comprising most positive contents was service environment ( . %), followed by patient safety ( . %). with regard to the topics that contained more negative contents than positive, the most one was doctor-patient relationship ( . %), followed by service efficiency ( . %), and nursing service ( . %). notably, over one third of contents in the appointment-booking service ( . %) revealed a neutral disposition. additionally, in contrast to the content volume distribution for the nine topics, the sentiment disposition of contents in corresponding healthcare services topics shows differences. for instance, table shows that the nursing service and doctor-patient relationship share an equal proportion ( . %) of contents in the corpus, however, we observed the disposition of contents from social media users to the two topics varied in figure . to our knowledge, this is the first study that has attempted to explore the public perceptions of healthcare services, using publicly posted materials, of two chinese social media platforms. our results showed that patient safety was the most significant topic for users of chinese social media platforms, followed by information technology and service efficiency. service environment was found to have the highest proportion of positive comments. the research assessed the application of content volume calculation and sentiment analyses on chinese social media data. the study is a crucial step to discovering the methodology on harnessing the social media data in china and an early attempt to track the perceptions of healthcare services in the public by analyzing a unique data source. this study found a large number of information technology and service efficiency, which might reflect the series of efforts made by both the government and the hospital in integrating information technology in healthcare services in china. several researchers have identified that health information technology services were used to enhance patient experience [ ] [ ] [ ] , and as a potential solution to shorten the lengthy waiting time in china's public hospital [ , [ ] [ ] [ ] . humanistic care was the least mentioned topic in the corpus complied by this study. it may suggest that chinese social media users are not very familiar with the idea of humanistic care. those who posted about it basically expressed a positive attitude. an alternative explanation might be this type of care has yet to reach the public only experienced by a few people. further empirical studies or controlled studies may be conducted to provide further insights. our research also explored the sentiment disposition of social media content on healthcare services: . % provided negative feedback. although this was only the initial results, it could be quite alarming to healthcare administrations and policymakers. despite the fact that patient surveys generally had favorable results in china [ ] , there was still a significant amount of negative comments to our knowledge, this is the first study that has attempted to explore the public perceptions of healthcare services, using publicly posted materials, of two chinese social media platforms. our results showed that patient safety was the most significant topic for users of chinese social media platforms, followed by information technology and service efficiency. service environment was found to have the highest proportion of positive comments. the research assessed the application of content volume calculation and sentiment analyses on chinese social media data. the study is a crucial step to discovering the methodology on harnessing the social media data in china and an early attempt to track the perceptions of healthcare services in the public by analyzing a unique data source. this study found a large number of information technology and service efficiency, which might reflect the series of efforts made by both the government and the hospital in integrating information technology in healthcare services in china. several researchers have identified that health information technology services were used to enhance patient experience [ ] [ ] [ ] , and as a potential solution to shorten the lengthy waiting time in china's public hospital [ , [ ] [ ] [ ] . humanistic care was the least mentioned topic in the corpus complied by this study. it may suggest that chinese social media users are not very familiar with the idea of humanistic care. those who posted about it basically expressed a positive attitude. an alternative explanation might be this type of care has yet to reach the public only experienced by a few people. further empirical studies or controlled studies may be conducted to provide further insights. our research also explored the sentiment disposition of social media content on healthcare services: . % provided negative feedback. although this was only the initial results, it could be quite alarming to healthcare administrations and policymakers. despite the fact that patient surveys generally had favorable results in china [ ] , there was still a significant amount of negative comments on the social media platforms. further and more detailed methodology is necessary to further understand the negative comments. in the topics investigated in this study, we found huge variations in the negative feedback as well as content volumes across topics. for instance, the contents related to doctor-patient relationship only take percentage of . % in the corpus, however . % of the content revealed negative feedback. the varied sentiment polarity distribution of the topics may have important policy implications for healthcare reform in china. for example, . % of the social media references to appointment-booking service reflected neutral feedback, which may suggest that the unsureness of the public on this novel service. patients have yet to be familiar with the services-even though it certainly aims to improve the convenience for patients as well as hospital efficiency. such feedback could be essential for hospitals to improve their service quality by enhancing patient education. further research might focus on what exactly were discussed in those negative posts so that targeted measures can be employed by the hospitals and responsible administrators to improve the services. in line with previous evidence [ , ] , our results show that social media could be a useful tool for health research in china, as well as english, and could be used to capture the public's perspective of healthcare [ , ] . however, it appeared that the most concerned issue of healthcare in social media is different from what has been found in patient surveys. findings from a recent qualitative study found that patients cared about the environment and facilities in hospital the most [ ] , whereas in our study patient safety issues had the greatest volume. another research examined the online doctor reviews in china revealed that most posts expressed positive attitudes towards the physicians [ ] . although the evidence on these issues are still not conclusive, it might suggest the perception difference between general public and patients. our research extends application of the natural language processing techniques to analysis of healthcare services related contents in china's social medial platforms and offers a new perspective of healthcare services in china's hospital. the results would be of benefit to healthcare providers and regulators benchmarking their performance on patient-centered healthcare delivery. this is important because the social media has been considered as a portal of health information acquisition for chinese netizens [ ] , the perspective of social media would be supplementary in understanding how consumer views the healthcare services in hospital besides the results from traditional paper-based surveys. this study has the following limitations. first, because the raw material was user-generated data, selection bias may have affected the data. for example, it was observed that most social media users were born in the s or s [ ], however we were unable to characterize the users social-demographic information in detail, since the user privacy policy of tencent currently prohibit such practice. moreover, considering the exploratory nature of the study, our study focused only on wechat and qzone as data sources, whereas other social media platforms in china may have the potential to conduct such analyses as well. second, since we derived the healthcare services categories and lexica based on the government document on nhsii and expert consultation, thus the corpus in this study may have failed to include certain amount of healthcare services related data. as a result, we may have underestimated the content volume of healthcare services from the two social media platforms. furthermore, although all the material in the databases are in chinese, and therefore most likely be generated by users from china, we are currently not able to determine whether the posts, containing the key terms on healthcare, were describing the chinese healthcare system or discussing foreign healthcare systems in chinese language. further research may strive to develop searching strategies that enable such distinction and increase the specificity of the results. third, although the consumer health vocabulary (chv) is the gold standard reference for retrieving the target data, it has been used in previous researches [ , ] , such open source of vocabulary list and its corresponding lexica are not available in chinese language. the accuracy and credibility of the sentiment analysis of this study also await further validation; however, it would require an alternative method to conduct sentiment analyses for chinese language and the possibility to apply such methods on the tencent data, which were publicly posted material but still under strict terms of utilization. another limitation concerned that we have no ability to confirm that the data supplied by tencent completely represent all users' data as there could be undocumented keyword filter on the platforms. these would inflict potential bias and limit the generalizability of our findings. weibo is another popular chinese social media platform considered to be the counterpart of twitter in china. future research could consider extend the analysis process to contents from weibo, to further explore users, and their views, that have not been covered in this study. both the quantitative approach, as shown in our research, and the qualitative approach, such as the face-to-face individual interview method, would be useful to better understand consumer care in healthcare services. there is a scarcity of empirical research exploring the latter issue at present. it has been proposed to complement public perspectives on healthcare services [ ] . furthermore, the popularity of consumers' unsolicited comments on healthcare providers in social media, prompts an important avenue for understanding patient experience, and has been demonstrated by previous researches [ , [ ] [ ] [ ] [ ] . future research for measuring patient experience based on social media data at hospital level would be help to better understand the landscape of healthcare quality in china. by analyzing shared information from wechat and qzone, this study showed that patient safety was the most concerned topic for users of chinese social media platform, followed by information technology and service efficiency, while the doctor-patient relationship was found to have the highest proportion of negative comments. this study explored the possibility of utilizing social media to monitor public perceptions on healthcare services. the findings provide an overview of public opinion on healthcare services, which could help regulators to set up the benchmark, on a national or regional level, to monitor the progress of healthcare improvements between comparator districts and services domains. it is also a necessary complement to the traditional paper-based consumer survey. the potential differences between social media perception and traditional consumer survey results would help regulators better understand the gap in quality of care services from various perspectives. further studies could also focus on extending the nlp method to a more content-based resource and to expand our understanding of mass opinion on healthcare services. the following are available online at http://www.mdpi.com/ - / / / /s , table s : list of keywords, terms, and text strings used for data searching. facing up to the threat in china violence against chinese health-care workers the danger of being a doctor in china the frequency of patient-initiated violence and its psychological impact on physicians in china: a cross-sectional study how to decrease violence against doctors in china? workplace violence against medical staff of chinese children's hospitals: a cross-sectional study media contribution to violence against health workers in china: a content analysis study of online media reports changing of china's health policy and doctor-patient relationship consumer satisfaction with tertiary healthcare in china: findings from the china national patient survey patient-centred healthcare, social media and the internet: the perfect storm? instagram and whatsapp in health and healthcare: an overview twitter as a tool for health research: a systematic review using twitter to measure public discussion of diseases: a case study social big data analysis of information spread and perceived infection risk during the middle east respiratory syndrome outbreak in south korea characterizing depression issues on sina weibo sentiment analysis of breast cancer screening in the united states using twitter using social media to characterize public sentiment toward medical interventions commonly used for cancer screening: an observational study social media in health-what are the safety concerns for health consumers? utility of social media and crowd-sourced data for pharmacovigilance: a scoping review protocol systematic review of surveillance by social media platforms for illicit drug use the development of online doctor reviews in china: an analysis of the largest online doctor review website in china unhappy patients are not alike: content analysis of the negative comments from china's good doctor website capturing the patient's perspective: a review of advances in natural language processing of health-related text china internet network information center the st china statistical report on internet development national health and family planning commission announcement of implementing the healthcare services improvement initiative national health and family planning commission the implementation strategy of the healthcare services improvement initiative social media landscape of the tertiary referral hospitals in china: observational descriptive study a way to understand inpatients based on the electronic medical records in the big data environment what predicts patients' adoption intention toward mhealth services in china: empirical study patient experience with outpatient encounters at public hospitals in shanghai: examining different aspects of physician services and implications of overcrowding discrete event simulation models for ct examination queuing in west china hospital questionnaire survey about use of an online appointment booking system in one large tertiary public hospital outpatient service center in china collecting and analyzing patient experiences of health care from social media what do patients care most about in china's public hospitals? interviews with patients in jiangsu province how the public uses social media wechat to obtain health information in china: a survey study predicting hcahps scores from hospitals' social media pages: a sentiment analysis web-based textual analysis of free-text patient experience comments from a survey in primary care use of sentiment analysis for capturing patient experience from free-text comments posted online harnessing the cloud of patient experience: using social media to detect poor quality healthcare we would like to acknowledge dalu wang and hongda wu from tencent for their technical support in data analysis. the authors declare no conflict of interest. int. j. environ. res. public health , , key: cord- - wihqs i authors: parvin, farhana; ali, sk ajim; hashmi, s. najmul islam; khatoon, aaisha title: accessibility and site suitability for healthcare services using gis-based hybrid decision-making approach: a study in murshidabad, india date: - - journal: spat doi: . /s - - - sha: doc_id: cord_uid: wihqs i healthcare accessibility and site suitability analysis is an elongated and complex task that requires evaluation of different decision factors. the main objective of the present study was to develop a hybrid decision-making approach with geographic information systems to integrate spatial and non-spatial data to form a weighted result. this study involved three-tier analyses for assessing accessibility and selecting suitable sites for healthcare facilities, and analysing shortest-path network. the first tier of analysis stressed the spatial distance, density and proximity from existing healthcare to find more deprived and inaccessible areas in term of healthcare facilities. the result revealed that spatial discrepancy exists in the study area in term of access to healthcare facilities and for achieving equal healthcare access, it is essential to propose new plans. thus, require finding suitable sites for put forward new healthcare service, which was highlighted in the second tier of analysis based on land use land cover, distancing to road and rail, proximity to residential areas, and weighted overlay of accessibility as decision factors. finally, in the third tier of analysis, the most suitable site among the proposed healthcare was identified using the technique for order of preference by similarity to ideal solution. the road network analysis was also performed in this study to determine the shortest and fastest route from these healthcare facilities to connect with district medical hospital. the present study found some suitable sites throughout the district on inaccessible zones where people are deprived from better healthcare facilities. this attempt will highly helpful for preparing a spatial decision support system which assists the health authorities regarding the healthcare services in inaccessible, underprivileged, and rural areas. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. the terminology of accessibility possesses the multi-layered and multi-faceted concepts which ascertain the quality of admitting approaches which provide a range of support services. potential accessibility ensures the optimum access to comprehensive and quality healthcare to every single individual of a population within a short of healthcare service providers [ ] . adequate accessibility to healthcare service is one of the vital elements for holding an advanced society status. thus, it holds a position in the th global targets set by the united nations for promoting sustainable development goals [ ] . who under the human right concept describe accessibility as availability of health services within a safe and reasonable physical reach to all section of the population especially vulnerable and marginal groups likely ethnic minorities and indigenous people, women, children, aged groups and persons with disabilities including in rural areas [ ] . a united states president's commission in sort to explain the meaning and electronic supplementary material the online version of this article (https://doi.org/ . /s - - - ) contains supplementary material, which is available to authorized users. conceptual problem related to accessibility that equitable access to healthcare should be in a manner that every single citizen can acquire an adequate level of medical care without excessive burdens [ ] . another commission came with a solution regarding the conceptual problems related to access and gave a comprehensible answer that the concept of accessibility is as important as the usage of service for health outcomes. their definition relies on both the concept of timely use of healthcare services and on the best possible use of health outcome [ ] . in a society, expenditure on healthcare is considered as the best social investment as healthy society is one of the fundamental aspects of development to promote social well-being and to minimize health disaster risk in many developing countries [ , ] . in india, despite economic advancement, inequality in healthcare is one of the primary challenges to meet development goal [ ] . several committees are set up to recommend public health policy aims to provide high-quality equal healthcare service to all likely bhore committee , ministry of health and family welfare , national urban health mission [ ] . despite all these efforts, a recent health survey reveals that only about % of indian population is served in government hospitals and about one-fourth income of each household has been invested in healthcare services [ ] . many studies attempt various techniques to get a clear understanding of the accessibility to healthcare centre and to delineate the deprived regions of these healthcare facilities [ ] . geospatial techniques are widely used in different field of studies related to healthcare for maximizing the geographical accessibility to medical services [ ] . gis is a platform which provides a framework in relation to the population for both assessments of the distribution of healthcare centres and evaluation of effective coverage [ ] . spatial or geographical accessibility generally refers to the physical access of a user to a provider's location [ ] or simply reflect the linkages between the point of supply and point of demand by taking consideration of existing transport framework and travel impedance [ ] . accessibility is a multidimensional concept which inherent both spatial dimension such as availability, accessibility and non-spatial dimensions like affordability, acceptability and accommodation [ , ] . khan [ ] highlighted the vehicular travel time/distance and euclidean distance for characterising spatial attributes to measure spatial accessibility. spatial separation based model is a suitable approach when there is incomplete and lacking transport network data and give desirable result for accessibility operation by using the physical distance between infrastructures as it only uses the location of services of interest [ ] . cumulative opportunity or isochrones approach is an effective method as it considers the elements of travel time as well as maximum desirable travel time by capturing land use pattern and infrastructural barrier across the land cover. gravity model is another model for operating accessibility provides the size of the zone of interest, the configuration of the zone, choice of attractor variables and the values of travel impedance time. besides these approaches, the two-step floating catchment area was ( sfca) proposed by luo and wang for calculating spatial accessibility [ ] . in this method, a floating catchment area is selected as a window to measure serviceto-population ratio for each healthcare service. after that, the entire ratio is summed up for each point of location within the catchment area and use it as an accessibility index of that location. enhanced two steps floating catchment area method come to overcome the rigidity and arbitrariness of the sfca i.e. it does not take into account the distance decay method, it sets catchment and subzones of healthcare by considering travel time or travel distance based on the road network is often used as the spatial barrier or impedance [ ] . three steps floating catchment area method used by rekha et al. [ ] to calculate accessibility by considering three attributes namely attractiveness of health services, travel time and distance between the location of the service centre and the location of residents and population demand for healthcare facilities. these all techniques have its advantages in term of application but the result will be incredible if geographic information system (gis) integrated for the spatial result. gis application in healthcare accessibility measurement is exclusively popular for two decades [ ] . gis is one of the sophisticated spatial analyst techniques that not only potential to identify demand flexible points based on residential clustering but also pinpoint spatial inequalities in healthcare delivery points and provide suitable locations for new health facilities [ ] . the geographical dimension of access can be authentically expressed by gis and appreciate the fact that gis technique has potential to fit in a wide range of aspects such as identification of vulnerable population who are devoid of service reach, delimit the points of quality service and treatment without looking at the loopholes in previous qualitative research [ ] . several studies found that gis technique is very useful in the demarcation of nearest healthcare centre for different road network by using patient's postal/zip code and converted then into grid reference to find straight line or travel time distance [ , ] . geographical information system applied to measure the relative importance of distance on providers to gain treatment for depression and also tried to understand the barriers regarding the adaptation of such medical facilities in rural as well as urban areas [ ] . distance and travel time are the most important factor for serving people because the number of death increases with increasing travel time to a hospital in a region [ ] . gis offers a distance tool to estimate travel time between healthcare and residential premises and also deals with the shortest and fastest path analysis to reach nearby healthcare in a short time interval. looking towards such advantages of geographic information system and geospatial analysis, the present study also emphasized and applied a hybrid decision-making approach with the support of gis. the present study aimed to utilize spatial tools to integrate different spatial and aspatial information for spatial analysis of healthcare accessibility and inaccessibility which support to propose new health infrastructures in inaccessible areas in murshidabad district of west bengal, india. such type of geospatial analysis for healthcare accessibility would be applied for identifying suitable sites and allocating new service areas, determining most ideal sites where allocation requirement has essential, and estimating the shortest and fastest distance between nodes of healthcare facilities. the study also offers assistance to health authorities to understand spatial pattern and distribution of healthcare availabilities and facilities for better service to inaccessible and deprived areas. murshidabad district (west bengal, india) is one of the classical provinces with rich historical background and also an important unit of the state, as it shares the largest international boundary with bangladesh in its eastern part. it is the northernmost district of presidency division of west bengal geographically lying between n and n and e and e (fig. ) . the district hq is behrampore. the district is boarded by burdwan and nadia district in the south and birbhum district and jharkhand state in the west and malda district in the north. river bhagirathi divides the entire district almost two equal parts, popularly known as 'radh' on the western side and 'baghri' on the western side. the total area of the district is km and holds the th largest position among the districts of the states in terms of land area. according to the census, murshidabad district is home of around , , people which is roughly equal to the total population of bulgaria and united states of washington [ ] . population density of the district is /km and the decadal growth rate is . %. the district has a large concentration of minority population which accounts % of the total population of the state where the majority are muslims; the sex ratio is per males and literacy is . % with a male and female literacy rate of . and . respectively. this district is a rural unit and a large number of the total workers accounts for . % of the total population engaged in other works such as labourer [ ] , followed by agricultural labourers i.e. . % and household industry workers contributing to . %. the above statistics on literacy, male-female ratio of literacy, and worker pattern indicate that this region is not well developed in term education and occupation. as far as the healthcare facilities are concerned, the district depicts a deprived health service profile where only one medical college and hospital is situated with a bed occupancy rate of . . there is only three super-specialist hospital and four sub-division hospitals are present with a bed occupancy rate of . and . respectively [ ] . rural hospital and public healthcare are also available but the service qualities are not well. moreover, the accessibility of these healthcare facilities is also a vital concern and need to bring focus on proper access to present institutions and also the elimination of disparity region. accessibility has a shorthand terminology with longhand sets of assignments for potential utilization of healthcare services which estimates the degree to which all individual of a population can reach needed services present within the defined distance or driving time. availability, affordability is another important component of healthcare utilization. optimal exercise of healthcare facilities assessment is not an easy task and can be done by estimating location-based accessibility and individual-based accessibility. spatial distribution of public health services illustrates a healthcare profile of any space. murshidabad district has an average portrait of medical services where availability of health institutions is not quite unacceptable but accessibility in terms of a positive outcome is not adequate. a positive outcome can be assessed through efficient treatment, adequacy of a speciality hospital, proper diagnostic and treatment skills of the provider. lack of this positive outcome makes an accessible profile of the district poor. murshidabad district come under the medium-to-low accessible zone for health service if only availability of medical institution will be the criteria but spatial location (distance, travel impedance, travel cost etc.) of the healthcare centres also a vital element for driving accessibility. the district has many government hospitals and public nursing homes under different categories such as one medical college and hospital, super specialist hospitals, sub-divisional hospitals, rural hospitals, and nursing homes. murshidabad district has blocks under subdivisions where the spatial distribution of healthcare centres is not advantageous as there is a trend of clustering can be found. maximum clustering of medical centres is found in certain blocks only such as behrampore, murshidabad-jiaganj, domkal, raghunathganj-i (table ) . behrampore block is the highest accessible area of the district where a cluster of many medical institutions are placed including medical college and hospital, public healthcare centres. suti-i, raghunathganj-ii, sagardighi, bhagwangola-ii, raninagar-ii, jalangi and bharatput-i blocks are the most inaccessible units of the district where a number of medical institution are very limited and rest of the block has moderate healthcare accessibility in terms of total medical institution establishment [ ] . healthcare accessibility is also illustrated by the efficiency of services which depends on the availability of the doctor. doctor-patient ratio is one of the most important mediating factors for individual-based accessibility. overburden of patients can lead to inappropriate treatment regimens due to inadequate doctor availability. out of blocks, only blocks possess good accessibility such as behrampore, raghunathganj-i, murshidabad jiaganj, domkal, kandi, beldanga-i blocks contains a good number of doctors among them behrampore has the highest number of doctors i.e. . remaining blocks have an inadequate number of doctors and possess low accessibility characteristics [ ] . a number of patients are another accelerating factor for visualization of healthcare status. behrampore block is still in the highest position in terms of a number of patients comes for treatment. a large number of patient in any healthcare centre can depict bilateral assumptions as one can be the better medical service attract the most of the patient and other can be the lack of sufficient medical institution can lead to high occupancy and burden rate. in the case of murshidabad district, the second one can be the accelerating factor. murshidabad-jiaganj, rghunathganj-i, kandi, nawda have experience high accumulation of patients, while raninagar-i, domkal, hariharpara, beldanga-i, nabagram have a medium rate of patients crowd. rest of the blocks such as farakka, samserganj, suti-i and ii, raghunathganj-i and so on have comparatively less number of patients as most of the patient use cross-border medical facility due distance from district medical college and hospital. although potential accessibility of healthcare service can not only be measured by single criteria or indicator as all the indicators are interdependent to each other to accelerate higher accessibility. an adequate number of the medical institution with sufficient appointment of doctors available to fulfil patients medical needs can promote higher healthcare status of any unit, if one indicator overburdens the other, the balanced will disturb and can be a dynamic force for inaccessibility. for this purpose, a relative accessibility index (rai) is a crucial factor for assessing the rate of accessibility of any region. murshidabad district has possession of low relative accessibility index. only a few pockets have high relative accessibility index such as behrampore (highest), murshidabad-jiaganj, and domkal, while rest of the blocks have low to very low status in terms of rai (table ). access to healthcare is a multi-fold concept and it mainly corresponds with many dimensions like availability, affordability, acceptability and geographical accessibility of the services. geographical accessibility and availability of healthcare services contain spatial dimension which can be analysed by geographical information system while the rest two i.e. affordability and acceptability are non-spatial dimensions. many types of research have been done to achieve higher accessibility to healthcare service mainly under the four notions: distance from the system works under two concepts i.e. nearest service centre to the population and average distance to the set of service centres, the threshold of the service, gravitational models for providers. distance is the major element to calculate higher accessibility to the service. sometimes it can be measured trough nearest location to the population, travel cost, travel time. nearest the location of a service centre lesser the travel time and will minimize the travel cost, ultimately provide higher accessibility. travel cost and the travel time will also be considered as an important element to measure the non-spatial dimension. geographical information system (gis) studies commonly used euclidean distance method to calculate nearest the location of a service centre i.e. distance from a population centre [ ] . this method faces drawback to provide suitable site mainly in urban areas where the population enjoys sets of service options within a certain point or point of reference. thus, average travel impedance to the service will be suited to ensure spatial accessibility as it incorporates both the entities; accessibility and availability to the population. the threshold of the service can be calculated by several patients per medical institutions. it also refers to the supply options which incorporates doctor-patient ratio, number of bed per person. this method can be shown by density analysis (point, line, kernel density) in gis researches. this method also has some demerits as it does not consider the cross-border population demand to reference supply point. the gravity model is an updated version on newton's law of gravity to analyse the spatial accessibility. this model overcomes the problems associated with former dimensions. it incorporates accessibility and availability of services within both rural and urban settings. it also helps to set the potential supply options to a certain set of potential population point. this model is thus: but the main problem with this is the distance decay coefficient b, which is usually not known and expressed in term of linear or exponential. two-step floating catchment area model: floating catchment area model was primarily employed by peng to analyse urban employment accessibility and further luo and wang also used this method to overcome problem arise for the gravity-based model to calculate spatial accessibility like quality and spatial resolution [ ] . in this method, a catchment area selection is required based on distance and travel time and a spatial accessibility value is appointed for each population point by adding up to the service-population ratio of all the catchments overlay on the point. following is the equation for measuring two-step catchment areas: for population point: where p k is the population size at point k, h j is the doctorpatient ratio, s j is the capacity of a particular healthcare centre, d o is the minimum travel time. but this method is imitated on selected catchment areas and not suitable for all areas. spatial accessibility value at the centre and periphery is higher and becomes zero just over the line. an intervention like flexibility in travel time can make variations in estimated spatial accessibility value. thus, a more improved method is needed to overcome this problem. enhanced two-step floating catchment area model: in this model, the whole catchment area is divided into several subzones with a distinct weight for accessibility, instead of fixing particular binary accessibility for the entire catchment area. following is the equation for computing this method: where p j is the doctor-patient ratio, s j is the capacity of the healthcare centre measured by bed availability or the number of doctors and w r is the accessibility weight appointed for each subzone depended on the distance d between the facility and population and also depend on intervention coefficient. this method also has certain limitation such as it does not take into account the fact that competition among the healthcare centres situated in a single catchment area. thus, some modification has to require and need to develop a more improved version. three-step floating catchment area model: this model is the extension of the previous method. the catchment area is devoted to each healthcare facility as well as population. it takes into account the travel distance and travel time for computing accessibility weight for each catchment (healthcare site) area. to overcome the problem of assigning equal accessibility value to each medical institution, a comparison weight is assigned to each healthcare service based on travel distance and time t d . where w ij and w ik are gaussian weights for service site j and population site k. this selection weight was further taken up in the subsequent formulas used to compute the doctor-patient ratios and the accessibility score as: for each service site: for each habitation: where s j is the capacity of the health care facility j, p j is the threshold of the service computed for each health care facility, p k is the population of habitation k and w r is the weight computed for each habitation and health care facility. but this technique also has some drawback and not satisfactorily accepted because only aspatial data have considered here but the availability of spatial data i.e. no. of health institutions in a particular area, the distance among them, density of health care in a particular area are not considered. thus, a new and hybrid approach is required through which spatial and aspatial information can be analysed, assessed and evaluated for a whole geographical area. to overcome all these problems present study tried to prepare a hybrid decision-making approach for higher healthcare accessibility assessment. in recent times, the geographical information system (gis) is used to prepare a hybrid model in which all aspects can be covered and merged for analysis. the present study has been carried through several steps to precede the decision-making approach. firstly, relative accessibility index (rai) has been estimated based on the existing situation and available data on no. of the medical institution, number of patients and number of doctors i.e. doctor-patient ratio. the rai of health care facilities is the indication of the areal proportion of health facilities which help in analysing accessibility and inaccessibility. for the same, euclidean distance, kernel density and proximate had been analysed to support suitability analysis of healthcare sites using the weighted linear combination. parallelly, topsis was applied to ascertain the most suitable sites where new health care facilities could be built to reach maximum people to provide better health service. finally, the shortest path network analysis was measured to connect and interlinked between existing and proposed healthcare. initially, to start the first hierarchy of decision making approach the relative accessibility index was calculated. it is obtained using the following equation: where mi is the no. of the medical institution, pi is the no. of patients, dj is the availability of doctors and h is the constant equal to . euclidean distance was measured among each healthcare presently existed. it is a measure of the true straight line distance estimation between two points 'x' and 'y' in euclidean space or along the 'x' and 'y' axis. it can be described by is putting pythagora's theorem in one dimensional and two-dimensional spaces where there is one variable describing each cell and can be expressed as: but in 'n' dimensional space or real-world scenario where each cell will have value 'x' for each variable, pythagoras's theorem is difficult to work, thus it can be overcome by measuring the distance between points which is stated as: where d xy is the distance between the points x and y which is equal to the sum from the first variable (p = ) to the last variable (n), of the squares of the distance from each dimension. density was measured to show the spatial availability of healthcare in the study area. it is one of the spatial analyst tools in gis environment for making density analysis of features in a neighbourhood around those features. it is a non-parametric technique generally used to visualize and analyse spatial data for mapping and estimating spatial pattern or event. kernel density calculates both point and line features around each output raster cell which is calculated by considering the total number of the intersection of the individual features. here the raster is calculated by the quadratic formula given by silverman where the highest value is placed at the centre of surface features and pointing towards zero with distance at the search radius [ ] . it can be calculated by using the equation: where 'k' is the kernel function with density f(y), 'y' is the sampled data, 'n' is the number of sample and's' is the smoothing parameter or say bandwidth. proximity tool was used to discover spatial association of features. with this tool output information is gained through the buffer and multiple ring buffers which create an areal feature at a specific distance around the input features. multiple buffers were linear for a small number of the foreclosed unit within various distance bands around a given point. present work presented a simple and efficient decisionmaking approach based on a structural and integrated method to deal with the decision-making problem. a novel group of hybrid decision-making framework has been built for evaluating accessible and inaccessible zone to healthcare services by integrating different raster layers i.e. euclidean distance, kernel density, proximity to support the weighted linear combination. weighted linear combination method is a multi-parametric decision model and comes under one of the fundamental classes of multi-criteria evaluation method in gis which follows the compensatory combination rules [ ] . this method has been widely used in other studies also, like in land-use suitability analysis [ ] , in suitability analysis for soil erosion [ ] , diseases susceptibility [ ] [ ] [ ] etc. present work accepted this technique to identify accessible and inaccessible areas for health care by applying equal weight. all selected raster layers were reclassified with equal cell size to combine them into a single accessibility layer. a weighted linear combination is defined as: where wi is the weight value of deciding factor i, pi is the selected raster input and n is the number of selected decision criteria. suitable sites for proposing and allocating new healthcare was determined using suitability analysis. site suitability is a process of allocation of new and ideal sites by analysing exiting site structure, pattern and condition based on several appropriate criteria. for this determination, the present study had prepared a suitable model for understanding appropriate location by integrating different thematic layers like road accessibility, railway network, land use land cover, and residential density. all these maps have been converted into raster so that each pixel can detect a score. it is important in suitability analysis to set a score for each category at - or - point scale as per their suitability. thematic maps were combined into composite suitability. for suitability analysis, first of all, land use land cover has been classified. barren, fellow land and low economic and less resourceful land has been considered for highly suitable to allocate new health care. secondly, the rail network and road accessibility have been considered for merging with the above-mentioned land category. areas properly connected through road and rail was taken as a suitable site for such allocation. parallelly, residential accessibility was also taken, km buffer of areas having high population get more preference for suitable sites. this decision approach supported to propose suitable sites for allocating new health care facilities in inaccessible areas. among this which site is best suitable and where argent requires for allocating new health care is determined using topsis analysis. topsis is the acronym of technique for order preference by similarity to ideal solution. this concept was first introduced by hwang and yoon in [ ] . topsis is one of the best multi-criteria decision-making methods used for selecting the best solution from decision criteria. there are adequate studies related to topsis application [ ] . using topsis, the ideal and non-ideal solutions are identified simultaneously. in the present study, topsis was used to identify the best site among the proposed suitable sites for health care service. this method is quite simple which is presenting a satisfactory performance in different field of applications. the idea of topsis procedure can be conveyed in a sequence of following steps [ ] . step prepare the decision matrix and determine the weight to decision criteria suppose, . . .w a n ) is the weight vector for a-expert or decision-maker, where w a þ w a þ w a þ Á Á Á þ w a n ¼ Þ and a = , , , … n. in a decision matrix, the linguistic term expresses low to excellent range, which has to convert using a point scale in topsis ( table ) . the selected criteria of the decision making can be: benefit functions (more is a high preference) or non-beneficial (less is a high preference) step calculate the normalised decision matrix ( x ij ). the normalised value x ij is expressed as: step calculate weighted normalised matrix by multiplying its associated weight. the weighted normalised value v ij is expressed as: step calculate the ideal best and ideal worst value where i and i is associated with the ascent and descent factor respectively. the ideal best and worst value is depending on the selected criteria. here, for selecting a suitable site for health care service, the lower distance from the transportation route and the residential area will get the highest preference value and vice versa. step calculate the euclidean distance from the ideal best now, the euclidean distance has to calculate from the ideal best value, s þ j . # : step calculate the euclidean distance from the ideal worst same as ideal best, the ideal worst value, s À j .is as follows # : step calculate performance score finally, the preference score or relative closeness to the ideal solution is determined. the pi is expressed by: the higher p i the value indicates the best site for allocating propose health care infrastructure. topsis is an efficient technique of multi-criteria decision analysis which emerges as a suitable technique for finding a suitable site and ideal solution. murshidabad district is one of the backward districts in west bengal, where about % of india's poor population reside. healthcare accessibility in this district is always a major issue as most of the inhabitants prefer to gain health services due to poor and inefficient access to medical care. the present study aims to explore the suitable site for medical institution after analysing the present situation of healthcare facilities within the district. for the existing situation of health care facilities, the relative accessibility index (rai) was calculated by considering no. of medical institutions, no.of patients admitted in a year, and no.of doctors available per day. the result of the existing situation of health care facility reveals that the spatial distribution is not uniform throughout the district (fig. ) . hence, for better treatment and getting well service, the resident has to travel another place after crossing a long distance, whereas, many suitable conditions for developing better service have already existed here. the numbers of medical institutions have clustered at the central part of the district i.e. the district capital, behrampore. as a result, the residents of the other areas are suffered to get better facilities. thus, the present study was carried out to find suitable locations for health care service by developing a hybrid decision model. for the same, the decision hierarchy was developed using existing facilities of health service, their spatial distance, density and proximity to support the suitable places; where better and well-accommodated health care service would be proposed by considering the local land use and distance to transportation route. after getting selected the proposed sites for local health care service, these are linked with district medical college and hospital located at the central part using shortest path network analysis. this effort will offer better health service to the residents reside at the peripheral part of the district and interlinked with medical college and hospital. the relative accessibility index (rai) of present health care service was calculated and the result reveals that only behrampore (the capital city of the district) block has good rai, whereas murshidabad-jiaganj and domkal have moderate rai and all others blocks have low to very low rai value. thus, from the overall spatial result of the relative accessibility index, it can be decided that the study area is poor in term of medical facilities and health care services. thus, looking towards this problematic issue, the present study proposed a hybrid decision model with three tiers of analysis to find suitable places for new health care and shortest distance to interlink with the district medical hospital. the first tier of analysis highlighted the distance, density and proximate of each existing health care to find more deprived and inaccessible areas in term of health service. the second tier of analysis emphasized to find suitable sites for proposing new health care services based on land use land cover, distance to road, rail, and proximity to residential areas. finally, the third tier of analysis highlighted the most suitable sites among the proposed health care and network analysis through the shortest path to connect with district medical hospital. figure a illustrates the prevailing conditions of health care services including medical college, hospital and nursing home. there are only one medical college and hospital is available. there are some other hospitals and nursing home also available both governmental and public but the spatial equality or homogeneity is not found. figure b -d show the distance, density and proximate to present healthcare facilities respectively. the result from each layer of distance, density and proximate reveal that the peripheral parts of the district have always lower facilities. the lower distance to healthcare indicates higher accessibility; lower density of healthcare indicates lower accessibility and closer to healthcare shows higher accessibility. these three spatial layers integrated to consider the accessibility and inaccessibility to healthcare facilities throughout the study area. the - point scale was used for linear combination i.e. for low accessibility (inaccessibility) and for higher accessibility of healthcare facility. figure shows the overlay result. it depicts the higher and lower spatial accessibility. this result supports the second tier of analysis i.e. to find suitable sites for proposing new healthcare facilities in inaccessible areas. the suitable sites were considered based on four decision factors. these factors were buffered around the road, buffer around rail, land use land cover and buffer around the settlement (fig. ) . if the suitable sites for healthcare facilities would locate within km, then it would be considered as more suitable than located far from the road because it will offer higher accessibility in term of travel time as well as travel coast. any healthcare that is located nearer to the railway, it will be considered as most accessible because of getting immediate and fast service. land use land cover should be considered before going to choose any space for locating health care. barren land and agricultural fellow nearer to the settlement would be the best site because this site will offer lower land price, utilization of land, and also getting close to residential areas. the sites that are located within km distance to populated areas the maps are produced with the help of data illustrated in table . will get the best service. thus, looking towards these conditions, suitable sites were proposed in the present study which can offer health service in inaccessible areas (fig. ) . the proposed health care in a suitable site can be merged and interlinked with existing health care to make the district enrich and accessible in term of health service. this is figured in supplementary file (s- ). it is essential to validate the location of each proposed site by verifying ground truth. in the present study, site- and site- were validated through the ground visit. but the rest sites were not visited; instead, their ground truth was measured in google earth search engine. all sites were selected in open space, barren land or agricultural land, by considering their location nearer to settlement, closer to transportable routes. these ground locations were also plotted in google earth search engine, which is shown in fig. . the technique for order of preference by similarity to ideal solution (topsis) was used to find the ideal best and ideal worst among the proposed sites. the ideal best and the ideal worst value was determined based on the above four decision factors. thus, for considering the most suitable site of health care service keeping transportation service, and nearer to residential areas; the lowest distance has given the highest preference. concomitantly, for land use, the unsuitable land use category has given the lowest preference (table ). the result shows that site- has the highest preference score (pi) with . . this site is far from the district medical college and other health care facilities and resides by a huge number of the rural population and therefore, it is the best site to shape modern health care to serve large people surrounding by connecting district medical college and another hospital on a transfer basis (figs. , ) . consequently, site- and have the lowest pi with . and . respectively. it is because these sites are within km from the district medical college, very close to rail and road transportation route and these sites are considered as already accessible. the other selected suitable sites have high to moderate suitability score depends on their location and health service requirements. finally, the shortest path network analysis was performed to measure the shortest open street distance and get access to reach district medical college and hospital in case of emergency. this task also supports the requirement to construct a new health care service in a suitable site. hence, the far distance from district medical college has the highest require score in comparison to located nearer distance. the shortest path network analysis reveals that site- and are located far distance with . and . km respectively which indicate more requirements to manage and construct new health care to offer better service to deprived groups of people. in comparison to site- and is much closer with . and . km correspondingly which indicate not a big issue would arise in case of not building new health care facilities (table ; fig. ). health is an important aspect of human existence as well as social well beings. good service in health can improve the quality of life and progress of a society. but recently, the rapid growth of population and enormous pressure on land, make the service worse. thus, the present study aimed to emphasize healthcare accessibility issues based on service and accommodation available in the study area. the study area, murshidabad district is a backward district of west bengal, india in term of basics infrastructural facilities and amenities [ ] . hence, the present study on healthcare accessibility and site suitability are required to highlight previous attempts evidenced that several studies defined accessibility in term of availability, accommodation, affordability, and sometimes acceptability [ ] . for example, aday and andersen [ ] defined healthcare accessibility based on the availability of health services with special reference to financial, informational, and behavioural influences. unlike, gulliford et al. [ ] focused on health demand by highlighting differentiation between having access to healthcare and gaining access to healthcare for overcoming the financial and organizational barriers from health service. all in all, other studies also evidenced common factors for determining healthcare accessibility like ( ) spatial distribution of healthcare facilities; ( ) transportation facilities and distance to healthcare centres; ( ) socio-economic conditions of nearing population group; and ( ) accommodation available in healthcare centres [ ] . based on these above-mentioned factors; recently, major concerns have been giving on geographic information system (gis) applications in the field of healthcare accessibility due to its efficiency and accuracy in spatial as well as non-spatial analysis [ , ] . site suitability is another aspect of the healthcare facility, in which major concerns have given towards suitable locations for constructing new healthcare to provide better service to target groups as well as overcome unequal distribution problems of healthcare service. site suitability is based on multi-factor analysis because searching and locating healthcare in suitable places are depended on more than one factor [ ] . many studies carried out in the field of site suitability of healthcare using gis and multi-criteria techniques. such as the optimum site selection for a hospital in tehran using a geographical information system [ ] ; the suitable site of a regional hospital in taiwan using analytic hierarchy process, sensitivity analysis, and delphi method [ ] . but previously it was not attempted to analysis healthcare site suitability by considering accessibility first. poor accessibility needs proposing new healthcare. so, it is essential to analysis accessibility first for proposing and constructing of new healthcare, which is covered in this study. unlike many studies only highlighted healthcare accessibility [ ] [ ] [ ] or site suitability [ , ] , the present study considered these inter-connected factors by developing a hybrid model. from that point of view, this study is unique and no similar studies ever carried out before. the present study would be useful to health planner in the study area as well as other regions also with similar geographical settings for defining inaccessible areas and locating suitable sites for better health service. while many previous researchers have highlighted the nonspatial data and statistical inference to analyse healthcare accessibility in a geographical location, the present study applied a gis-based hybrid decision-making approach for assessing the spatial accessibility of healthcare facilities and site suitability analysis in murshidabad district of west bengal, india. this study offered a hybrid decision-making approach for proposing suitable sites regarding better healthcare service. to provide better service and reach a deprived group of people, a pipe dream was prepared that needs for logical decision making and resolve existing problems. the result reveals that spatial discrepancy exists in case of access to healthcare facilities. the location of existing healthcare primarily clusters in the central and northern portions. the distance, density and proximate analysis of these healthcares explored the spatial inaccessible areas. to achieve equal access, allocation of new healthcare is essential to reduce the spatial disparity. thus, the equal weight-based weighted linear combination was performed using land use, proximity to road and rail, and distance to residential areas to support suitable site for determining and allocating new healthcare facilities. decision support system with gis integration offered suitable sites in inaccessible areas. poor accessibility and poor health services in an area increase health and social disparities. hence, the urgent requirement is needed to increase accessibility. the present study emphasized the same issue and developed a hybrid approach to integrate b fig. the ground truth areas of proposed healthcare sites after suitability analysis a site- : considered as best site and urgent require for new healthcare, this site is . km from rajgram rail station, surrounded by dense rural population and no healthcare facilities nearby, b site- : very close to nh and located in a sparse populated areas, c site- : far away from nh , nh and railway junction, d site- : . km from bhagwangola railway station and located in a densely populated areas, e site- : very close to ganga river and sagar para road, also located near many densely settlement areas, f site- : locate at south-west corner of the district and very close to sh , g site- : this site is very close to district medical college and hospital, h site- : just beside sh , goghata bus stoppage and about . km from ramel health destination multiple factors to propose sites for new healthcare facilities and remove spatial disparity in the study area. the advantages of developing and using a hybrid model are ( ) it integrates different models and approach, ( ) it increases the accuracy of the result and reduces the drawbacks of single model and method, ( ) it interlinks two or more aspects of a study, for instance, in case of the present study using a hybrid model two aspects, i.e. accessibility to healthcare and site suitability of healthcare have been determined, and ( ) hybrid model helps in simplifying the complex relationship of among criteria or perspective. however, a hybrid model also suffers from some disadvantages, like ( ) it is more complex to apply ( ) the preparation of model take more times than single model ( ) sometimes it also suffers from overfitting etc. therefore, removing such disadvantages and adopting the abovementioned advantages, the present proposed and used a hybrid model to show healthcare accessibility and site suitability. this study would appear like a good source of health service enhancement and plan implementation to policymakers and health planners. recently, not only our country but the world worried about the outbreak of 'novel coronavirus'. the government truly finds enormous space for 'isolation' service. globally , , confirmed cases are reported (till . . ). india is no exception in this case, where, , confirmed cases are identified. it is assumed that murshidabad is also too much vulnerable as there is a lack of basic infrastructure. therefore, in this regards, it is recommended that government and local planners can start medical emergency in proposed sites with primary equipment and service to reach target population groups. on getting success in the mission, modern infrastructural development and service could be proposed afterwards. accessibility analysis of health care facility using geospatial techniques un chief urges greater efforts to improve health and well-being of indigenous peoples human rights and health. world health organisation president's commission for the study of ethical problems in medicine and biomedicine and behavioral science research president's commission delivering quality health services: a global imperative for universal health coverage. geneva: world health organization. licence: cc by-nc-sa . igo. retrieved on convergence and determinants of health expenditures in oecd countries the determinants of health expenditure: a country-level panel data analysis. geneva: world health organization inequities in access to health services in india: caste, class and region the challenge of building rural health services deprivation, healthcare accessibility and satisfaction: geographical context and scale implications a literature review of the use of gis-based measures of access to health care services measuring geographic access to health care: raster and network-based methods measuring spatial accessibility to primary health care services: utilising dynamic catchment sizes measuring time accessibility and its spatial characteristics in the urban areas of beijing the concept of access: definition and relationship to consumer satisfaction an integrated approach to measuring potential spatial access to health care services accessibility evaluation of land-use and transport strategies: review and research directions measures of spatial accessibility to health care in a gis environment: synthesis and a case study in the chicago region. environment and planning b: planning and design evaluating the accessibility of healthcare facilities using an integrated catchment area approach is there a role for gis in the 'new nhs'? gis and public health accessibility to general practitioners in rural south australia: a case study using geographic information system technology the impact of geographic accessibility on the intensity and quality of depression treatment accessibility and health service utilization for asthma in retrieved from murshidabad district density estimation for statistics and data analysis weighted linear combination method versus grid based overlay operation method-a study for potential soil erosion susceptibility analysis of malda district (west bengal) in india. the egyptian journal of remote sensing and space science integrating geographical information systems and multiple criteria decision making methods using analytic hierarchy process with gis for dengue risk mapping in kolkata municipal corporation spatial susceptibility analysis of vector-borne diseases in kmc using geospatial technique and mcdm approach. modeling earth systems and environment mapping of mosquito-borne diseases in kolkata municipal corporation using gis and ahp based decision making approach application of multi-attribute decision-making methods in swot analysis of mine waste management (case study: sirjan's golgohar iron mine, iran) using hca and topsis approaches in personal digital assistant menu-icon interface design an algorithmic method to extend topsis for decision making problems with interval data appraisal of infrastructural amenities to analyze spatial backwardness of murshidabad district using wsm and gis-based kernel estimation using gis for determining variations in health access in jeddah city, saudi arabia framework for the study of access to medical care what does 'access to health care' mean? literature review of the use of gis-based measures of access to health care services development of a web based gis for health facilities mapping, monitoring and reporting: a case study of the zambian ministry of health hospital site selection using two-stage fuzzy multi-criteria decision making process hospital site selection using fuzzy ahp and its derivatives optimal selection of location for taiwanese hospitals to ensure a competitive advantage by using the analytic hierarchy process and sensitivity analysis publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations acknowledgements we thankfully acknowledge the anonymous three reviewers and the editor in chief for their valuable time, productive comments and suggestions for enlightening the overall quality of our manuscript.funding no fund was received from any sources. conflict of interest on behalf of all authors, the corresponding author states that there is no conflict of interest. key: cord- -r a qoks authors: mellis, alexandra m.; potenza, marc n.; hulsey, jessica n. title: covid- -related treatment service disruptions among people with single- and polysubstance use concerns date: - - journal: j subst abuse treat doi: . /j.jsat. . sha: doc_id: cord_uid: r a qoks individuals with substance use disorders (suds), including those in long-term recovery, and their loved ones are facing rapid changes to treatment and support services due to covid- . to assess these changes, the addiction policy forum fielded a survey to their associated patient and family networks between april and may , . individuals who reported a history of use of multiple substances were more likely to report that covid- has affected their treatment and service access, and were specifically more likely to report both use of telehealth services and difficulties accessing needed services. these findings suggest that individuals with a history of using multiple substances may be at greater risk for poor outcomes due to covid- , even in the face of expansion of telehealth service access. covid- -related treatment service disruptions among people with single-and polysubstance use concerns individuals with substance use disorders (suds), including those in long-term recovery, and their families are facing rapid changes to sud treatment and recovery support services, including mutual aid groups, due to covid- . ensuring access to treatment and recovery services is essential, given that stress, such as that brought on by the pandemic, can worsen sud outcomes (sinha, ) . however, many sud treatment settings have operated at reduced capacities, closing some units or ending group therapies (roncero et al., ) . clinicians and regulators have responded by increasing availability of telehealth services, however, in an effort to continue providing sud care despite challenges in face-to-face health care provision. as one example, practices for prescribing medications for opioid use disorder, in particular, have shifted to allow more unsupervised dosing (alexander, stoller, haffajee, & saloner, ) , which can increase patient autonomy (columb, hussain, & o'gara, ) . however, not all suds are treated with medications that can be administered remotely, and not all services can be provided remotely and of services that can be, not all are recommended for all levels of sud severity (ornell et al., ) . some individuals with suds are likely to encounter difficulties in accessing quality care, a concern of not only those individuals, but one clinicians share as well (bojdani et al., ) . at particular risk for other psychiatric problems are people with polysubstance use concerns (connor, gullo, white, & kelly, ) ; this group also tends to report higher utilization of more -intensive‖ services, such as inpatient and residential care (bhalla et al., ) . given that polysubstance use may be an indicator of higher-risk substance-use behavior, we examined j o u r n a l p r e -p r o o f journal pre-proof diminished access to treatment and recovery support services among individuals who reported using both single and multiple substances. the addiction policy forum (apf) fielded an uncompensated survey via email to their national (u.s.) network of patients, families, and survivors, with promotion through apf's state chapters to increase recruitment (hulsey et al., ) . a total of , participants, including , complete responses, responded between april , , and may , . the integreview irb approved the study procedures. we queries participants regarding the substances they or their family members used (alcohol, stimulants, opioids, nicotine, marijuana, sedatives, and other), and whether anything about their sud recovery and treatment access had changed due to covid- . if participants said their access had changed, we then asked them to self-report specific changes: inabilities to access needed services, needle exchanges, and/or naloxone; access to telehealth, curbside pickup for medications, and take-home dosing. the full text of these items is available in the appendix. we sought to determine whether specific groups with substance use concerns were more likely to report that they had unmet service needs. we examined the relationship between endorsement of the statement -unable to access my needed services‖ (coding individuals who said treatment had not changed due to the pandemic as not endorsing this item) as a function of the number of substances respondents endorsed, using logistic regression. we controlled for gender and race as categorical variables, and age and education as ranks. we repeated regression j o u r n a l p r e -p r o o f journal pre-proof analyses excluding those who did not report suds themselves, with no meaningful differences in interpretation. demographics and substance use data are reported in table , stratified by reported single substance or polysubstance involvement. we observed no differences in age, race, ethnicity, gender, or education relative to single substance and polysubstance use. as anticipated, endorsing involvement with any one substance also meant individuals were more likely to endorse involvement with multiple substances. polysubstance use was also associated with reported changes in treatment or recovery support service access due to covid- ( % among people reporting polysubstance use versus % among those with single substance use). in particular, polysubstance-involved respondents were more likely to report inability to access naloxone ( . % versus . %) and needle exchange ( . % versus . %) services, engagement with telehealth services ( % versus %), and general inability to access needed services ( . % versus . %). all differences withstand a bonferroni correction ( . / = . ), except for the reported inabilities to access naloxone and needle exchange services. we used logistic regression to determine whether the number of substances with which someone was involved, a proxy for severity of polysubstance use, statistically predicted endorsement of difficulty accessing services. the number of substances with which someone was involved was significantly and positively associated with probability of difficulties accessing treatment (b= . , std. error= . , z= . , p= . ), controlling for age, gender, race, and education ( figure ) . we also observed that individuals (n= ) who reported genders other than male or female (including nonbinary, other, and preferring not to disclose) were more j o u r n a l p r e -p r o o f journal pre-proof likely to report that they were unable to access their needed services (b= . , std. error= . , z= . , p= . ). given that some treatment access may be particularly relevant for opioids, we repeated logistic regressions in post-hoc analyses, replacing the number of involved substances with a binary indicator of involvement versus no involvement with opioids. opioid involvement was associated with increased likelihood of being unable to access needed services (b= . , p= . ). to explore other substances (without correction), we observed similar patterns for sedatives (b= . , p= . ), stimulants (b= . , p= . ), and nicotine (b= . , p= . ), but not alcohol (b= . , p= . ) or marijuana (b= . , p= . ). among the single substance-involved individuals, nearly half ( ) reported involvement with only alcohol, and next most common was opioids ( respondents). repeating the logistic regression with binary indicators of alcohol only (b= - . , p= . ) and opioids only (b= - . , p = . ) indicated that both single substance-use indicators are negatively associated with difficulties accessing treatment, further supporting single substance use being associated with fewer difficulties in treatment access. limitations include the cross-sectional design and that we collected data using self-report and online, which may restrict the representativeness of the sample. respondents studied here included both individuals with suds (n= ) and family members (n= ), and different biases may exist in each group. future studies should examine similarities and differences between respondents with suds and family members of individuals with suds. despite the limitations, the results provide important insight into a clinically relevant situation during the covid- pandemic and related rapid changes to treatment provision. journal pre-proof individuals with high-risk profiles-those who use multiple substances-are more likely to report diminished access to their needed services despite increased access to and/or utilization of telehealth services. this suggests that covid- may especially impact polysubstance users, in terms of treatment disruptions and recovery support. we also observed that despite these changes, they are still reporting unmet service needs. this finding may suggest that these individuals have greater needs for the types of services that have been restricted during the pandemic (including face-to-face care and group therapies). some focused efforts at addressing treatment needs during covid- have specifically targeted service provision for individuals with moderate to severe suds, particularly in the context of buprenorphine for opioid use disorder (e.g., samuels et al., , harris et al., . however, the current findings suggest that more may be needed, including research to investigate the efficacies and impacts of specific approaches (e.g., telemedicine). journal pre-proof the x axis depicts the number of substances participants endorsed using (including alcohol, nicotine, opioids, marijuana, sedatives, stimulants, and others). the y axis depicts the percent of this group reporting that they were -unable to access needed services‖ for treatment and recovery support, specifically due to changes in service because of covid- . error bars indicate % confidence intervals. an epidemic in the midst of a pandemic: opioid use disorder and covid- covid- pandemic: impact on psychiatric care in the united states addiction psychiatry and covid- : impact on patients and service provision polysubstance use: diagnostic challenges, patterns of use and health low barrier tele-buprenorphine in the time of covid- : a case report covid- pandemic impact on patients, families and individuals in recovery from substance use disorder the covid- pandemic and its impact on substance use: implications for prevention and treatment the response of the mental health network of the salamanca area to the covid- pandemic: the role of the telemedicine innovation during covid- : improving addiction treatment access how does stress increase risk of drug abuse and relapse? key: cord- - p efxo authors: daniels, norman title: resource allocation and priority setting date: - - journal: public health ethics: cases spanning the globe doi: . / - - - - _ sha: doc_id: cord_uid: p efxo there has been much discussion of resource allocation in medical systems, in the united states and elsewhere. in large part, the discussion is driven by rising costs and the resulting budget pressures felt by publicly funded systems and by both public and private components of mixed health systems. in some publicly funded systems, resource allocation is a pressing issue because resources expended on one disease or person cannot be spent on another disease or person. some of the same concern arises in mixed medical systems with multiple funding sources. risks matters, not just the aggregate impact. resource allocation in public health thus focuses on deciding what risks to reduce-which depends in part on their seriousness as population factors and who faces them-and how to reduce risks. the cases in this chapter that discuss resource allocation force us to contemplate decisions about priorities in public health as opposed to the more frequently discussed medical issues about health care priorities. later we suggest that making decisions about these issues should be part of a deliberative process that emphasizes transparency, stakeholder participation , and clear, relevant reasoning. collectively, these resource allocation cases bring out several important points. separately, they raise other central issues. it is worth noting these general issues before commenting on the more specifi c problems raised by each case. the fi rst point the cases collectively make is that effi ciency has ethical and not just economic importance (daniels et al. ) . if one health system is more effi cient than another, it can meet more health needs per dollar spent than the less effi cient one. if we want systems to meet more health needs, and we should, then we prefer more effi cient health systems. specifi cally, if we think we have obligations to meet more health needs, or if we think meeting more "does more good," and we ought to do as much good as we can with the resources we have, then we have an ethical basis for seeking more effi cient health systems. the economic pursuit of effi ciency should not, then, be dismissed as something that has no ethical rationale. a second point the cases collectively make is that effi ciency is not the only goal of health policy , for we have concerns about how health benefi ts are distributed as well as how they add up. health policy is not only concerned with improving population health as a whole, but also with aiming to distribute that health fairly (daniels ) . that means many resource allocation decisions involve competing health policy goals. the point about competing goals is illustrated by a problem often encountered in policy decisions: should we always favor getting the best outcome from the use of a resource, or should we give people "fair" chances to get a benefi t if it is at least signifi cant (brock ) ? for example, during an i nfl uenza pandemic, should we allocate ventilators to those with the best chance of survival, or should we give signifi cant but lesser chances to a broader group? reasonable people often disagree about when the difference in expected benefi ts means we should favor best outcomes over fair chances, or even about what counts as a fair chance. hence, a third point emerges from the cases taken collectively: reasonable people often disagree about the choice, and it is not possible to simply dismiss one side as irrational or insensitive to evidence and argument (daniels and sabin ) . indeed, reasonable people will disagree about how much priority to give to the sickest (or worst off) patients. they may think we have to weigh the seriousness of an illness against the potential benefi t that we know how to deliver, they may disagree about how to trade off those considerations, or they may disagree about when modest benefi ts to larger numbers of people outweigh greater benefi ts delivered to fewer people. together these "unsolved rationing" problems-the best outcome versus fair chances problem (when to prefer best outcomes to fair chances), the priorities problem (how much priority to give to those who are worst off), and the aggregation problem (when do modest benefi ts to more people outweigh significant benefi ts to fewer people)-mean that there is pervasive ethical disagreement underlying many resou rce allocation problems (daniels ) . there are other common sources of disagreement. one of the most common sources of controversy in resource allocation decisions arises when a particular intervention is seen as the last chance to extend life by some-a necessity if we are to act compassionately-and when it is seen primarily as an unproven intervention by others that we have no obligation to provide it. denials of such interventions in last-chance cases have been considered the "third rail" of resource allocation decisions (daniels and sabin ) . here we have two competing public value s-compassion and stewardship-and most public offi cials would prefer to be seen by the public as committed to saving lives rather than as ha rd-nosed stewards of collective resources. the cases taken collectively bring out one fi nal point: our main analytic tools for aiding resource allocation decision making are limited in several ways, particularly by insensitivity to various ethical issues, especially issues of distribution. in short, these tools may take the fi rst point, about the importance of effi ciency , seriously, yet fail to help us with the second and third lessons the cases collectively bring out, that we are also interested in distributing effi ciently produced health fairly, and that reasonable people disagree about how to do that. to see this, consider two widely used tools: comparative effectiveness research (cer) , which has been given prominence as a r esearch focus in the patient protection and affordable care act of , and cost-effectiveness analysis (cea) . both help to answer policy-making questions. for example, a typical use of cer compares the effectiveness of two interventions (drugs, procedures, or even two methods of delivery), and policy makers may want to know if a new technology is more effective than older technologies. of course, they may also want to know if the new technology provides additional effectiveness at a reasonable cost , which points to a shortcoming of much cer in the united state s, where considerations of cost are generally avoided. similarly, if there is only one effective treatment for a condition, cer tells us nothing useful. it also tells us nothing about whether a more effective intervention is worth its extra cost. and, cer cannot help us compare intervention outcomes across different disease conditions, since it uses no measure of health that permits a comparison of effectiveness. indeed, decision makers face many resource allocation questions that cannot be answered by cer, even if cer can help avoid wasteful investments in interventions that do not work or that offer no improvement ov er others. in germany, however, cer is combined with an economic analysis that takes cost into account and that allows the calculation of " effi ciency frontiers " for different classes of drugs (caro et al. ) . presumably, this method could be extended to different classes of public health interventions if they are grouped appropriately. to calculate an effi ciency frontier, the effect of each drug in a class in producing some health outcome is plotted against its cost , and the curve is the effi ciency frontier for that class of drugs. it is then possible to calculate if a new intervention in that drug class improves effectiveness at a price more or less effi cient than what is projected from the existing efficiency frontier. this use of cer allows german decision makers to negotiate the price of treatments with manufacturers, rejecting payments that yield ineffi cient improvements. german policy makers can then cover every effective intervention sold at a price that makes it reasonably effi cient. still, because german use of cer cannot make comparisons across diseases, it allows vast differences in effi ciency across conditions. cea aims for greater scope than cer. it deploys a common unit for measuring health outcomes , either a disability-adjusted life year (daly) or a quality-adjusted life year (qaly) . this unit purports to combine duration with quality, permitting us to compare health states across a range of disease conditions. with this measure of health effects, we can construct a ratio (the incremental cost-effectiveness ratio, or ic er) of the change in costs that results from the new intervention with the change in health effects (as measured by qalys or dalys). we can then calculate the cost per qaly (or dal y) and arrive at an effi ciency measure for a range of interventions that apply to different condi tions. critics have noted p roblematic ethical assumptions in the construction of the health-adjusted life-year measures and in the use of cea (nord ; brock ) . to see some of these problems, consider the following table: rationing problem cea fairness priorities no priority to worst off some priority to worst off aggregation any agg regation is ok some aggregations ok best outcomes/fair ch ances best outcome s fair chances cea systematically departs from judgments many people will make about what is fair. the priorities problem asks how much priority we should give to people who are worse off. by constructing a unit of health effectiveness , such as the qaly, cea assumes this unit has the same value , regardless of who gets it or wherever it goes in a life ("a qaly is a qaly" is the slogan). but intuitively, many people think that a unit of health is worth more if someone who is relatively worse off (sicker) gets it rather than someone who is better off (less sick) (brock ) . at the same time, people generally do not think we should give complete priority to those who are worse off. we may be able to do little for them, so giving them priority means we would have to forego doing more good for others. few would defend creating a bottomless pit out of those unfortunate enough to be the worst off. similarly, cea assumes that we should aggregate even small benefi ts. then, if enough people get small benefi ts, it outweighs giving large benefi ts to a few. but intuitively, most people think some benefi ts are trivial goods that should not be aggregated to outweigh larger benefi ts to a few (kamm ) . curing many people's colds, for example, does not outwei gh saving a single life. finally, cea favors putting resources where we get a best outcome, whereas people intuitively favor giving people a fair (if not equal) chance at a benefi t. locating an hiv/aids treatment clinic in an urban area may save more lives than placing a clinic in a rural area, but in doing so, we may deny many people a fair chance at a signifi cant benefi t (daniels ) . in all three of these examples of rationing problems, cea favors a maximizing strategy, whereas people making judgments about fairness are generally willing to sacrifi ce some aggregate population health to treat people fairly. in each example, whether it is giving some priority to those who are worse off, viewing some benefi ts as not worth aggregating, or giving people fair chances at some benefi t, fairness deviates from the health maximization that cea favors. yet we lack agreement on principle s that tell us how to trade off goals of maximization and fairness in these cases. people disagree about what trades they are willing to make, and this ethical disagreement is pervasive. determining priorities primarily by seeing whether an intervention achieves some cost/qaly standard is adopting a health maximization approach. this approach departs from widely held judgments about fairness, even where people differ in these judgments. thus, the national institute of clinical and health excellence (nice) in the united kingdom has had to modify its more rigid practice of approving new interventions only if they met a cost/ qaly standard in the face of recommendations from its citizens council. this council, intended to refl ect representative social and ethical judgments among british citizens, has proposed relaxing nice's threshold in various cases where judgments about fairness differed from concerns about health maximization. the judgments of the citizens council in this regard agree with what the social science literature suggests are widely held views in a range of cultures and contexts (dolan et al. ; menzel et al. ; nord ; ubel et al. ubel et al. , . there are, of course, those who criticize departures from the nice threshold of the sort that the citizens council recommended. compromising the maximization of health that cea promotes may be seen as a moral error, perhaps the result of elevating the rescue of an "identifi ed" victim (say, a cancer patient whose life might be extended modestly by a new drug) ove r benefi ts to "statistical" lives (using the resources to provide greater benefi ts to others). the reasonable disagreement about how to proceed suggests that we should view cea as an input into a discussion about reso urce allocation, not as an algorithm for making decisions. this "aid to decision making" role was proposed by the public health service in its recommendations about the use of cea (gold et al. ) . in short, controversial ethical positions are embedded in cea, and using cea uncritically commits one to these views, even though many disagree with them. we have already noted that the effi ciency of a health system has ethical consequences. but what should we count as effi ciency ? should we use our resources to generate more revenues for a unit of the health system-say, a hospital? doing so would defi ne effi ciency the way most businesses do: other things being equal, an allocation that produces a greater return on investment is a more effi cient use of stockholder or owner resources. alternatively, we might narrow the range of effects to health effects on the covered population . then we have greater effi ciency when an allocation produces more positive health effects in that population than an alternative allocation. the case guzmán brings from colombia raises this issue forcefully. should hospitals, or a specifi c health plan, allocate resources favoring services (certain treatment s) that raise more revenues than an alternative allocation (certain preventive measures)? perhaps the gains from the treatments will involve fewer population health gains over time than those obtained by the preventive or health promotional measures, even if they show their improvement more quickly and so look better sooner. which plan should the policy maker adopt? this issue examines our purpose in designing a health system. is it to meet the health needs of a population or is it to provide a good return on investment for those who invest in health services? we might think that this question is easier to answer in a system where health care delivery is seen largely as a public undertaking aimed at improving population health. in such a system, it might seem that there is only one purpose behind the health care system. return on investment for the taxpayer funding such a system should be measured by how effi ciently the system improves population health. in systems where resources are owned privately (and there are many of these), however, it seems we must consider at least two goals. even if the private sector must in part seek to improve population health , which may be a requirement of state-imposed health care regulation or, in some people's opinions, a social responsibility of corporations, private health-care organizations still must deliver a reasonable return on investment for owners. thus, policy makers within private health-care organizations have a dual task. balancing return on investment with improvement in populatio n health thus becomes the central issue in the colombian case study. the chilean case written by gómez and luco raises a similar issue, but this case focuses on measurable differences in the cost effectiveness of certain services and in the severity of two conditions. if we consider only cost effectiveness, we view effi ciency in one way-the best health outcomes in the aggregate for the population for an investment in health. if we take severity of condition into account, we might view this as an equity demand-in which case, we have an effi ciency-equity confl ict and must make a trade-off. or, we might think of effi ciency as a ranking of needs by severity of condition. in the latter, the resource allocation case turns on how we defi ne effi ciency. specifi cally, the chilean category of guaranteed health interventions could include cataract surgery (the leading cause of blindness in the chilean population), but not multiple sclerosis (ms) treatment s, which might be viewed as maximizing effi ciency in a standard sense. or, the guaranteed health interventions scheme could include the less cost-effective treatment of ms but not cataract surgery, since ms is viewed as a more severe condition (because it can be life threatening and lead to premature death), even if it is far less prevalent than cataracts. if this were the case, the more effi cient system, in this nonstandard view, would rank treating more severe conditions as more effi cient than treating less severe conditions. if budget limitations mean only one should be included in the guaranteed health interventions program, either m s or cataract surgery, which should it be? the cataract surgery intervention delivers a signifi cant benefi t in terms of qalys to a larger part of the population than does the intervention package for ms, but the greater severity of premature death seems to be an important reason for favoring ms. if this reason is given priority over cost effectiveness and over the standard view of effi ciency , then are less effective treatments for more severe conditions supposed to have priority over more effective and cost-effective treatments for less severe conditions? if so, what kind of a health system does that produce if all needs can not be met given resource limits? alternatively, do we want a system that always we ighs cost effectiveness more highly than the severity of a condition that some people have? that too seems problem atic. suppose we think improving population health is a worthwhile and defensible goal of a health system, we favor improving population health over increasing revenues for the private sector (in the guzmán case), and we also favor giving priority to cost effectiveness over severity of a condition (in the gómez and luco case). a confl ict still remains between health maximization in the aggregate and concerns about equity , as illustrated in the blacksher and goold case (and arguably in the case about triage in pand emics by smith and viens). in the case that blacksher and goold describe, the task is to decide whether to reallocate resources from a program focused on maternal-child health and reduction of b lack-white in fant mortality dis parities to a program that may get more health per dollar spent through other interventions. infant mortality among blacks and whites has declined rapidly in the united state s; and in absolute terms, the decline has been more rapid for blacks. still, the ratio of black infant mortality to white infant mortality has increased. because the public health department is in a highly segregated city, this shift in program focus might seem to require viewing the remaining bl ackwhite health d isparities as morally a cceptable (especially given the high rate of improvement that past programs gave to black infant mortality rates). when should we view health disparities as morally acceptable? when should we weigh reducing health disparities as more important than some aggregate gains in health that we know how to produce in a population ? if public health has two goals-improving population health and distributing that health fairly-how should we weigh the goals when they confl ict? one important feature of the blacksher and goold case, namely the opinions within the community whose inequalities are at issue, is really a feature to which nearly all cases warrant attending. people affected by a policy ought to have some infl uence in determining that policy. some people might believe this is what democracy requires. a diffi culty this view of democracy faces, however, is that those who speak for the community may not appropriately represent the community affected by the decision. nevertheless, the opinions of a broader range of stakeh olders may improve deliberation (depending on how those opinions are managed). it may also improve the acceptance of the decisions, which arguably enhances the legitimacy of the decision-making process . resistance to including a broader range of stakeholder s in decision making about health priorities may come from a concern that they bring with them "partiality." this resistance may come from the view that greater impartiality leads to better deliberation. arguably, this concern about partiality ignores the positive gains that partiality often brings to deliberation, especially if we know how to manage such deliberation so that we minimize the risk s that partiality sometimes brings. we need such management skills in any case since partiality is unavoidable in most contexts. rather than banning what cannot be eliminated, managing partiality in deliberations is the best way to improve decision making in contexts of reasonable disagreement. the confl ict between improving population health and treating people fairly can arise in other contexts. arguably, the problem raised by smith and viens about the principle that should govern triage in pande mics can be viewed as a confl ict between health maximization, in this case, saving the most lives, versus recognizing the claims that the sickest people have on us for assistance. ordinarily, health systems give some priority to those who are sickest, but should that priority disappear in favor of saving lives when scarce resources, such as ventilators, are allocated in pandemic conditions? if we allocate our ventilators to the sickest patients, we may save fewer lives than if we allocate them to those whose lives we can better expect to save. even if we think we should give priority to those worst off, do we ordinarily think that concern for them should govern triage policy in pandemics? if we believe saving the most lives trumps concerns about helping those who are sickest in pandemics, can we justify why the priority we give to the sickest should be revised in pandemics? suppose we have an acceptable way of measuring the burden of disease in a population , and according to this measure, mental illness is not given the priority it ought to have. that is, it contributes more to the burden of disease than is normally recognized in standard health systems, which provide too few services to meet mental health needs. this is the problem upon which rentmeester et al.'s case focuses. specifi cally, some mental health conditions require signifi cant resources for what medicaid terms as "behavioral management," which is seen as a social support service not a medical treatment . as a result, these services, to the extent they are provided, fall to state-funded social service budgets. the services place a burden on state fi nances that would be diminished if they were instead included in medicaid bud gets ( % of which are fi nanced by each state). arguably, the stigma that attaches to mental health issues is one important reason for this underprovision of social supports for people with mental health issues. in nebraska, the political opposition to expanded medicaid coverage through the affordable care act ad ds to the burden on state budgets and the potential under-servicing of these mental-health induced needs. it takes resources to meet public health needs. suppose we can increase the resources to meet some of those needs by accepting a pu blic-private partnership that improves a compromised private partner's image? should we meet health n eeds at this price? that is the issue posed by the hernández-aguado case from spain . specifi cally, should public health authorities put their stamp of approval, in the form of their logo, on fl u epidemic notices printed on soft drink labels? the inclusion of the logo is a requirement of the private entities that are willing to donate space on the labels of their products. obviously, this provides a form of public support for soft drinks that arguably contribute to obesity in a population and thus to the prevalence of noncommunicable diseases associated with obesity. but in view of the low budgets available for fl u warnings, is this a price worth paying? what would the decision maker have to know about the effects of such labels to decide this case, or is the decision something that can be made independently of the specifi c payoffs of implementing the warning system? is there a way to consider the cost and assess whether the outcome of the warning is worth this price? is this simply an effi ciency calculation about the cost effectiveness of reducing a disease burden in this way? one fi nal crosscutting issue lurks behind all the cases in the resource allocation chapter (perhaps all the cases in the volume)-namely, the nature of the decisionmaking process that addresses the issues they raise. public health decisions about resource allocation-judging from the cases on that topic in this volume-face reasonable ethical disagreement. that is because the tradeoffs involved in the two main goals of public health policy -improving population health and distributing health fairly-are trade-offs about which people often reasonably disagree. how can public health decisions be made in real time, given these ethical disagreements, in ways that enhance their legitimacy and are arguably fair to all parties? one approach to the problem is to construct a fair process for making those decisions and to rely on the outcomes of such a process. people will judge the outcomes of a fair process to be fair (daniels and sabin ) . what conditions should such a decisionmaking process meet if it is to be considered fair? four conditions are arguably necessary (even if some may think they are not suffi cient and want to add others): ( ) the decisions and the rationales for them should be made public. ( ) they should be based on reasons all think are relevant. ( ) they should be revisable in light of new evidence and arguments. and ( ) , these conditions should be enforced so that the public can see that they obtain. some explanation is needed for these conditions. the publicity condition is widely embraced, even if it is fairly strong. it calls for the grounds for decisions-not just the content of the decisions-to be transparent. people have a right to know why decisions that affect their health are made the way they are. moreover, making the reasoning for such decisions public is a way of exposing them to scrutiny so errors in reasoning or evidence can be detected and decisions improved. even though we may not be able to be explicit in advance about all criteria we use to decide such cases, that is, we may work out our reasons through deliberation, we can explain on what we base our decisions. and that gives people affected by our decisions the knowledge they have a right to possess. the search for reasons that all consider relevant to making a reasonable public health decision about resource allocation can narrow disagreement considerably. even if people can agree on what reasons they think are relevant-in the spirit of fi nding mutually justifi able grounds for their decisions-they may not agree about the weight they give these reasons. one way to test the relevance of such reasons is to subject them to scrutiny by an appropriate range of stakeholder s. what counts as appropriate may vary with the case. who should be heard in deliberations is itself worthy of deliberation. stakeholders raise different arguments that should be heard, and including their voices improves buy-in to decisions. since stakeholders may not in many instances be elected representatives, we may be skeptical about whether the democratic process is improved by including them, but, if the deliberation is well managed, the quality of the discussion may improve greatly. the revisability condition , requiring that decisions be modifi able in light of new evidence and argument, is also widely embraced and not considered controversial. decisions are made on the basis of evidence and arguments, and better evidence and arguments may emerge that require revisiting some decisions. some decisions can then be modifi ed, though it may be too late for others, and our consolation is that we made the best choices we could, given the evidence and arguments. the intent of the enforcement condition is to ensure that the other, more substantive, conditions are met. sometimes enforcement is a matter of state regulation . sometimes it can be the result of vol untary conformance with a process. since ethical disagreements abound in resource allocation decisions , we need a process that enhances legitimacy. but can we claim that a decision-making process that is fair yields fair outcomes? one view is that we may ultimately become persuaded by a good argument that fairness requires a different decision than one that emerged from a fair process. we can in this way defeat the fairness we might ordinarily attribute to the outcome of a fair process. does the prospect of defeating the fairness of a decision emerging from a fair process mean that we should not attribute fairness to the outcomes? alternatively, we can admit that the fai rness that comes from a deliberation is only "defeasible" fairness, but it is the fairest conclusion we ca n reach at the time. during the s, many latin american countries began reforming their health systems according to a neoliberal development model that emphasizes free markets (homedes and ugalde ; stocker et al. ) . approved in , health reform in colombia was supposed to overcome problems such as low coverage, inequality in access and use of health care services, and ineffi ciency in the allocation and distribution of resources. but the reform also hoped to encourage more focus on illness prevention and health promotion and more community participation in health decision-making processes. the reformers advocated predominantly for neoliberal value s like effi ciency, free choice, universality, and quality. although they were also committed to the communitarian values of solidarity , equity , and social participation . the colombian health reform was one of the fi rst examples of implementing managed competition in the developing world (plaza et al. ) . to stimulate competition among insurers and health service providers, both public and private, health reformers applied the theory of managed competition (enthoven ) . according to this theory, competition achieves effi ciency and reduces cost , making health care services responsive to consumer needs (londoño and frenk ) . hospitals become responsive when they are able to sell services and become fi nancially sustainable. to achieve sustainability, supply subsidies (direct transfers from the state to hospitals) had to replace demand subsidies (transfers directed to the poor through a subsided s ecurity plan). the colombian reform established a general social security system in health that featured two insurance plans: ( ) the contributory plan, fi nanced by mandatory contributions (formal employees and employers from the public and private sectors). ( ) the subsidized plan, funded by resources from the contributory plan and from taxes and other sources, which covered people unable to pay (vargas et al. ) . the actors of the system are the insurance companies, the health service providers, and the state regulatory organizations. insurance companies contract with health service providers, and the regulatory organizations control compliance with the defi ned basic health packages. to optimize resources, the reform placed controls on medical practitioners and established explicit priority criteria based on clinical guidelines that defi ned benefi t packages. from , some adjustments to the reform have been introduced, such as the creation, in , of the institute for health technology assessment to provide a n evidence base for health decisions. the institute recommends which medical technologies should be paid with public resources on the basis of which technologies optimally improve the quality and cost effectiveness of medical care. to determine these technologies, it conducts health outcomes research that guides technology development, evaluation, and use (giedion et al. ) . nevertheless, years later, the promise of reform lies unfulfi lled and many patients still experience high out-of-pocket costs, long wait times, or denial of services. to access health services, frustrated citizens are turning to the legal system as a last resort and, by so doing, congesting the courts (defensoría del pueblo ). physicians are responding to economic incentives and penalties by restricting hospitalization time and decreasing the use of expensive diagnostic tests and specialist referrals (abadía and oviedo ) . to further reduce labor costs, service providers have increased the workload of health profession als and the number of patients seen per day, whi le reducing the time spent with each patient (defensoría del pueblo ). insurance companies often take a long time to pay health service providers, and they also contract their own service network (a process known as vertical integration), so many public hospitals are in serious fi nancial diffi culties. meanwhile, hospital workers frequently disrupt the normal operation of hospitals as they strike to improve work conditions and have their paychecks issued more promptly. should hospitals fail- % of the public hospitals in colombia are classifi ed as being at medium or high fi nancial risk -nearly ten million people could be left without health service (ministerio de salud y protección social ; quintana ) . add to that, the reforms have increased inequity, as more affl uent patients can more easily access quality health care services than can low-income patients (vargas et al. ) . the described problems refl ect a complex situation that requires profound structural reform . as one way to address the immediate problems of effi ciency and quality, colombia in instituted public hospital accreditation. accreditation requires hospital directors to reach goals in service delivery related to fi nancial viability, quality, and effi ciency. hospital boards can now fi re directors who fail to meet these g oals within a specifi ed period (rodríguez ) . given the imbalances between budgets, service demands, and ongoing costs, hospital directors face enormous challenges and ethical dilemmas in formulating and executing their mana gem ent plans. you are a director of a public hospital that focuses on health promotion and prevention activities, such as general practice, dentistry, clinical laboratory, hospitalization, and emergency care. in developing your management plan, you must make decisions about which services to prioritize . if you prioritize services that represent higher revenues and lower costs as a way of conserving resources, you may have to reduce priority for some services. to guide your decision making, you conducted a retrospective study of service billing in the past years and learned that the clinical laboratory and external medical consultation yielded higher incomes. the lowest yielding programs in the short term-vaccination , educational programs to improve lifestyles , and provision of micronutrient supplements to children and pregnant women-were associated with the best long-term health results. taking seriously your fi duciary responsibilities, you try to guarantee fi nancial sustainability by containing labor costs, restricting consultation times, and shortening hospital stays. your challenge is to do these things without diminishing the quality of patient care. but because you compete with other institutions, you must also assure suffi cient reserves to maintain and update medical equipment that will improve the "sale of services." knowing that every management decision you make will affect the population you serve, you begin to refl ect on the factors affecting your h ospital man agement plan. . who are the major stakeholder s in this case and what are their interests, value s, and moral claims? between which of them are there ethical confl ict s or tensions? . which of these interests, values, and moral claims should be prioritized? how would you justify your priorities? . would you prioritize programs that in the short term brought in needed revenues or those programs that had highest impact long term? . how can tensions between the goals of effi ciency, fi nancial viability, and quality be resolved? what weight should be assigned to each goal by the hospital board when evaluating your performance? . at least in the short run, the new reforms seem to be prioritizing effi ciency, viability, and quality over equity . should a health system attain the former goals before tackling the problem of equity, or should it insist on equity from the start? . can equity in health care be achieved without doing something about wealth inequity and other social determinants of health? . should you justify your decisions by emphasizing solidarity with other hospital directors and seeking community support? . how could collaborations between public health, communities and the health care system begin to address neoliberal concern s with effi ciency, viability, and quality? the global burden of disease (gbd) compares disease burdens based on epidemiological measures of prevalence, mortality, disability, and associated cost s. the gbd for mental illness amounts to % of the world's total disease burden (world health organization ). i n the united state s alone, every fi fth child suffers from a mental disorder (perou et al. ) . although mental illness clearly causes disabilities (prince et al. ), underservice to those with mental illness is commonplace. lack of access to mental health services counts as the fi rst of many hurdles facing families who have a child with a mental illness. stigma and the lack of parity in health coverage for physical and mental illness are other hurdles for these families. not surprisingly, these hurdles can critically affect the development of children with mental illness. lack of access to mental and behavioral health services for children years and younger especially threatens their development. rapid brain growth occurs in the fi rst years of life, which lays the foundation for cognitive, emotional, and moral development. exposure to chronic stress can prompt the release of hormones in the brain that can have enduring consequences for how the adult brain is organized and how it functions (shonkoff and phillips ) . because poor health can show up in children as developmental delay, access to mental and behavioral health services is critical. longitudinal studies demonstrate positive and long-acting effects of early childhood interventions, such as environmental enrichment programs, on a range of cognitive and noncognitive skills, social behaviors, academic achievement, and adult job performance (heckman ) . the esti mated annual rate of return on investment from targeted early childhood development programs is %, and early intervention reduces the predictable need for higher, more costly levels of care in later life (heckman et al. ) . in the united state s, medicaid is a government-funded program that provides health coverage to people with certain disabilities and to low-income adults and their children. the federal medicaid act (fma) requires states participating in medicaid programs to provide medically necessary treatment to eligible children. under federal medicaid law , states must provide "early and periodic screening , diagnostics, and treatment," also known as epsdt services, to eligible medicaid recipients under age (u.s.c. § d(a)( )(b)). the defi nition of epsdt includes necessary health care , diagnostic services, treatment, and other measures described in the medical assistance subchapter for the united states code ( u.s.c. § d (a)) ( ) that correct or ameliorate defects and physical and mental illnesses and conditions discovered by the screening services, regardless of whether such services are covered under the state plan ( u.s.c. § d (r)( )) ( ). the medical necessity standard , which is based on clinical standards of care, refers to interventions that may be justifi ed as reasonable, necessary, or appropriate. states must comply with the fma standard to cover all treatments for a medicaideligible child's physical or mental condition, even if service coverage is optional for adults covered by medicaid. fma also bars states from arbitrarily denying or reducing the amount, duration, or scope of a required service to an otherwise eligible recipient solely because of the diagnosis, illness, or condition (nebraska legislature ). despite the provisions of fma, the u.s. department of health and human services, which oversees the medicaid program, excludes certain behavioral health treatments for children with developmental disabilities and autism (national health law program ; autism society of nebraska ). in addition, some states' medicaid contracts allow insurers more freedom than other states to deny payment for services. states also vary in who-the claimant or the insurer-must prove whether coverage provisions are adequate or fall short of federal medicaid legal standards (rosenbaum and teitelbaum ) . differences among states in approval of payment for specifi c treatments, including mental and behavioral health treatment, illustrate the need for more consistency in medicaid coverage provisions and the lack of parity between mental and physical health coverage. mental health benefi ts must be offered at parity with medical services to newly eligible recipients as part of the patient protection and affordable care act (aca), and medicaid expansion controversy is clear evidence that parity is a work in progress (mental health america ; u.s. department of labor ). because of inadequate coverage for mental and behavioral health services for medicaid-eligible children , some parents have no option other than to surrender their child to the child welfare system so that the child will receive full coverage for necessary mental and behavioral health care services. this results in signifi cant cost-shifting from medicaid to the state's child welfare system. that is, when a state provides federally mandated services to medicaid-eligible children, it receives a fi nancial match from the federal government to pay the cost s. when a state denies federally mandated medicaid services and a family surrenders a child to state custody so the child can receive care, the state pays the expense of the previously denied medicaid costs plus the expense of entitlements the child acquires as a ward of the state. the aca medicaid expansion offers a window of opportunity to increase coverage for behavioral health treatment for children with mental illnesses. although the federal government will bear the primary fi nancial burden of medicaid expansion, some states have elected, for political reasons, not to participate in this expansion. for participating states, aca medicaid expansion will replace state and local mental health services funds with federal medicaid money that will cover a wider range of home and community-based services for mental illness treatment (bazelon center for mental health law ). public health agencies and leaders often provide input for the medicaid system, helping to develop protocols, criteria, and rules about which treatments are defi ned as medically necessary . such decisions about medical necessity affect clinicians, patients, and families because they determine which treatments get recommended at the clinical level and infl uence which treatments insurers cover. you are the medicaid director of a state with the country's highest percentage of children in the child welfare system. twenty-fi ve percent of children in the state's foster care system are there not because of abuse or neglect, but because of behavioral problems and mental illnesses. as a state offi cial, you are aware that this results in signifi cant cost-shifting from medicaid to the state's child welfare system. recently, the case of -year-old sam has come to your attention. sam's family cannot afford mental and behavioral health care for sam, although he is medicaideligible and insured through magiscare (a private company with a state contract to administer medicaid for mental and behavioral health services). sam's parent s are considering surrendering their boy to become a state ward to get him the mental health services he needs. sam, you learn, eats random objects and dirt, throws tantrums, bangs his head on the ground, hits and bites himself and others, and often runs away. recently diagnosed by his physician as having autism, sam was referred to a psychologist who recommended outpatient behavioral therapy. both the physician and the psychologist expect this therapy to be covered through the family's magiscare plan. magiscare denied the psychologist's requests for payment on the grounds that, for children of sam's age, behavioral management is not covered under state law because it is not "medically necessary." magiscare substantiated their denial of payment because sam's behaviors primarily refl ect developmental disabilities related to autism, which are not covered under their contract with the state. when you ask the magiscare executive director about this case, she suggests that sam's parent s could attend therapy sessions to help them cope with their son's behaviors, but she reasserts that behavioral management is not covered for children as young as sam under state law because it is not medically necessary. members of the state legislature and child mental health advocacy groups are trying to expand access to home-based and community-based mental health services. they have asked you to support their efforts. you also consider that your governor, who is your boss, has publically stated his fi rm opposition to aca medicaid expansion, thus denying the state the opportunity to expand coverage for children's mental and behavioral health treatment through the aca. at present, you know that your state is offering limited mental and behavioral health service s and that narrow defi nitions of medical necessity are used to limit access to those services. as the state medicaid director, which steps should you take? . who are the main stakeholder s in this case, and what are their primary interests? . "passing" the expense of coverage denied by medicaid to other components of public service, such as the child welfare system, has fi scal and social implications. (a) what are some of these implications? (b) how should prevalence, mortality, disability, and cost be factored into thinking about ways to balance short-and long-term risk s and benefi ts to individuals and to the public in this case? . suppose a policy advisor warns that expanding behavioral health care for children will strain the medicaid budget and require cuts in services for adults or reduce their eligibility. (a) how should you respond? (b) which considerations or priorities would guide your funding allocations? . what role should ethical principle s such as stewardship , public health leadership , and moral courage play in this case? . medical necessity implies an acute care model of health service delivery and refl ects a clinical perspective. how well does this idea apply to a public health prevention model of health service delivery? are there better alternatives? . parity in insurance coverage for mental health is federally mandated for private insurers, which covers most citizens, but has proven to be an elusive goal for people who do not have private insurance or do not have enough coverage. medicaid is a public ( government funded) insurance program, not a private one. although medicaid benefi ciaries receive coverage for medically necessary mental health services, e ach state defi nes medical necessity uniquely. (a) should a federal mandate defi ne medical necessity for mental and behavioral services? (b) what fi nancial implications would such a mandate have from a state perspective and from an overall perspective? . the term principle-policy gap can be used to characterize situations in which most people support health coverage in principle ; but in practice, they are unable to pay for coverage or unwilling to take the political , social, cultural, or fi scal risk s necessary to enable such coverage. what do such gaps tell us about which value s the majority favors, and how might the term principle-policy gap help us understand the dynamics in this case? what roles should public health leaders play in responding to principle-policy gaps? public health systems are usually underfunded in comparison with health care systems. in fact, the organisation for economic co-operation and development (oecd) countries allocate on average only % of their health spending to pub lic health and prevention activities (oecd ) . this low funding of public health programs hinders the capacity to implement effective public health policies (robert wood johnson foundation ). population health challenges, such as infl uenza pandemics, are increasingly complex, and tackling them involves urgently executing a wide array of public health measures to prevent disease transmission. in the case of infl uenza pandemics, measures can vary from border quarantine, social distancing, provision of antivirals and vaccine s, and personal hygiene strategies. recommendations often need to be made quickly even when knowledge about the seriousness and potential health and social effects are incomplete. the target for preventive interventions is the entire population. however, resources for intense and sustained health campaigns through mass communications are expensive. in addition, the social determinants of the disease must be understood and considered (crowcroft and rosella ) . this typically involves the need for policies that engage the health and non-health sectors, such as educational policies and social or economic factors (savoia et al. ). this complexity, together with decreasing funds and other factors, has contributed to increasing private sector involvement in health care. according to the world health organization (who), a public-private partnership gathers a set of actors for the common goal of improving population health through agreed roles and principle s. this may also be described as public sector programs with private sector participation (who ). who has described several types of partnerships, including philanthropic, transactional, and transformational. sponsorship is a form of a public-private partnership defi ned as "any form of monetary or in-kind payment or contribution to an event, activity, or individual that directly or indirectly promotes a company's name, brand, products, or services" (kraak et al. ) . in this sense, sponsorship is a commercial transaction, not type of philanthropy. public-private partnerships have become increasingly common for public health campaigns. some transnational companies and their corporate foundations collaborate with public institutions, such as united nation s agencies and government s, to tackle complex public health problems, such as treatment of diarrhea in developing countries (torjesen ) , tuberculosis , and malaria (ridley et al. ) . these collaboration s have been encouraged by international institutions and experts as a way to mobilize resources and expertise, which could complement the public sector. who has also encouraged using public-private partnerships to deliver health services for a range of health problems, including hiv infection, malaria , tuberculosis , trachoma, and vaccine-preventable diseases (buse and walt a , b ) . however, corporations' increasing role in public health has been criticized as jeopardizing the mission of public health and its commitment to population health (hastings ; ludwig and nestle ) . some corporations have used tactics that discredit public health actions, such as distorting scientifi c information and using fi nancial tactics and political infl uence to avoid unfavorable regulations (wiist ) . public health profession als, public health agencies, and governments often must decide whether to collaborate with the private sector to improve population health. these decisions are increasingly frequent as health department budgets shrink and public-private partnerships are seen as a way to secure funds for core public health programs. ethical considerations can help us decide whether and when to form such partnerships. however, the available public health ethics frameworks (e.g., public health leadership society ; nuffi eld council on bioethics ; kass ) do not specifi cally discuss public-private partnerships. only the public health leadership society provides guidance for such collaborations. principle proposes that, "public health institutions and their employees should engage in collaborations and affi liations in ways that build the public's trust and the institution's effectiveness." continued discussion about the ethical implications of private-public partnerships is needed. top health offi cials in an industrialized country have declared a public health emergency due to an infl uenza pandemic. the head of the country's health department receives a call from the president of a multinational company that produces sugary, high-calorie drinks. the company president expresses his concern about the pandemic and wants to collaborate with the government to prevent the spread of fl u. the company offers the health department a considerable amount of space, onethird of each can, on its star product (a soft drink) free of charge, to include messages on fl u prevention . the company insists that the health department logo be included on the can along with the preventive messages. for them, the association between the health department (through the logo) and their product is essential for the collaboration as it would be an acknowledgement by the health department of the company's social responsibility. the head of the health department arranges a meeting with several health authorities and offi cials to consider the offer. on one side, some members of the group support the proposal because of the need to carry out far-reaching public health campaigns to limit the impact of pandemic fl u. at that stage, the incidence of pandemic fl u is increasing quickly and the number of new outbreaks in schools is worrying the health authorities and the population . there have been recent budget cuts to the health department, and some offi cials argue the company's contribution may be the best option to ensure a far-reaching campaign on prevention measures to benefi t the population. they see sponsorship as a form of social responsibility because the company does not have any apparent economic interest in fl u-related activities. they also note that there are no other companies offering a similar collaboration. but other offi cials say the company's soft drink products contribute to the obesity and diabetes epidemic and that the company's use of the health department logo would label it a pro-health industry with the backing of the highest health authority in the country. they also raise concerns about risking the independence of the health department in future regulatory action on sugar-rich beverages. as the hea d of the health department, you must decide if you should collaborate with the company. . what considerations should the health department director weigh when deciding whether to collaborate with the beverage company? . who are the major stakeholder s the health department should consider, and what value s might each of these stakeholders bring to this decision? . in making your decision, what values should be prioritized? . what positive or negative impacts would displaying the health department logo on the soft drink cans have on health department operations? . how might sponsorship by a company that produces sugary beverages affect public trust in the health department and the institution's effectiveness? . would the decision be different if the company produced healthy foods and the department's logo was placed on a healthy product? . would community involvement facilitate decision making and the consideration of the ethical questions? what ethical criteria or guidance should be established to accept or reject a future donations or sponsorship of a public health program by a company? preterm births, the leading cause of infant mortality, are increasing annually worldwide (world health organization ). the united state s shares company with nigeria, india, and brazil among the top ten countri es with the highest numbers of preterm births and ranks st among organisation for economic co-operation and development ( in , about infants died per live births. by , that number fell to . . during the last half of the twentieth century, the rate of black infant mortality dropped dramatically. in , black infant mortality was . deaths per live births compared with . deaths per live births among whites (mechanic ) . but by black infant mortality fell to . deaths per live births compared with . deaths per live births among whites. as these numbers show, both groups made signifi cant absolute gains, with blacks gaining more in absolute terms-a reduction of . for blacks and . for whites. yet, black infant mortality still remained about twice that of whites. these disparities have persisted in the twenty-fi rst century. in , non-hispanic black women experienced the highest rate of infant mortality, with . infant deaths per live births, while non-hispanic white women had a considerably lower rate, with . infant deaths per live births. citing a report from the national healthy start association, macdorman and mathews ( ) report that programmatic efforts to reduce disparities in black-white infant mortality have had some successes at local levels, but eliminating the disparities is diffi cult. the u.s. centers for disease control and prevention and the u.s. department of health and human services have prioritized both the elimination of health disparities and improvement in overall population health. these twin goals-one distributive, the other aggregative-are separate and sometimes confl ict (anand ) . increases in health disparities often accompany advances in aggregate gains in population health (mechanic ) . although this case is specifi c to the united state s, the dilemma is not. data show that signifi cant progress on child mortality has been made in many countries but that this overall success is often coupled with increased inequalities between advantaged and disadvantaged groups (chopra et al. ) . in china and india, for example, disparities in mortality persist between boys and girls younger than years, a function of entrenched gender discrimination (you et al. ) . these examples raise challenging questions about how ethically to assess such cases and set priorities for the allocation of scarce public health resources. you serve as the director for the local health department in a racially segregated urban city in the midwest with one of the greatest concentrations of african americans in the united states. the city has a long history of civil rights activism that led to protests and marches that ultimately empowered and mobilized black communities and organizations. your health department has a history of prioritizing maternal-child health and the elimination of black-white disparities in infant mortality in its programs, an investment of resources affi rmed by the city residents through the department's community outreach program and planning processes. chronic underfunding of public health, made worse by the economic downturn, has resulted in drastic and unprecedented reductions in the public health budget. in consultation with your staff and community board of health, you have raised the possibility of redirecting resources from maternal-child health into other programs based on a number of practical and ethical considerations. as with national statistics, the city has seen signifi cant declines in black infant mortality, even as blackwhite disparities remain. you note that although the maternal-child health programs are cost-effective, their impact on reducing black-white disparities seems to have stalled. other programs appear to meet targets more consistently. to help support these other programs, you note that allocating resources to more effective programs provides more "health" per dollar, thus meeting the utilitarian demand to maximize overall health, which many view as the primary goal of public health and health policy (powers and faden ) . in addition, although black-white disparities in infant mortality persist, blacks have made signifi cant gains, declining more than whites in some decades. you note that remaining inequalities could be deemed ethically acceptable by some standard s of equity , such as the "maximin" principle . although this distributive principle is subject to interpretation (van parijs ) , it is generally understood to require that social and economic inequalities work to benefi t society's least advantaged groups. thus, inequalities (even signifi cant ones) are morally acceptable as long as the least advantaged have signifi cantly benefi ted (powers and faden ) . the director of community outreach proposes that the health department not make this decision unilaterally, but instead listen to community opinions on these questions of priorities and fairness. he suggests that the health department collaborate with community partners to host a series of public forums. he insists that a topic of such historic and contemporary concern to the community must be subject to public deliberation. despite having a history of supporting community discussions, you are concerned about the cost of community forums, noting that they will drain resources from an already slim budget. the chilean sy stem of guarantees in health-created by law in -aims to establish guaranteed health care interventions in health promotion, disease and injury prevention , diagnosis and treatment , rehabilitation and palliative care (ministerio de salud ) . the law mandates that public and private insurers provide the resources needed to protect the public against excessive health-related spending and guarantee timely and universal access to authorized interventions based on standard s of care. national health objectives, established by the ministry of health, determine the list of guaranteed interventions. this list, however, is reviewed every years and amended as new scientifi c and health information emerges. as of , the system o f guarantees in health included interventions for health-related conditions (ministerio de salud ), accounting for almost % of the chilean burden of disease. the system of guarantees in health is a priority system based on acknowledged criteria, namely scientifi c evidence and socially shared value s. for the system to be effective, the criteria must be transparent, publicly accepted, and open to review and modifi cation. the law that created the system of guarantees in health also mandated a procedure for selecting the guaranteed interventions (ministerio de salud ) . the procedure factors in public opinion research to identify social consensus on health priorities, studies to identify effective interventions that prolong and improve quality of life, and assessments of interventions' cost effectiveness (burrows ). the procedure determines priorities with an algorithm that includes these factors and information on disease burden and health system capacity (missoni and solimano ) . after choosing the health interventions, the health ministry elaborates on a package of interventions related to specifi c health conditions and develops clinical guide lines for such interventions. you direct a team within the ministry of health that is responsible for recommending priorities for guaranteed health interventions. the priority ranking system emphasizes the selection of cost-effective interventions for conditions with the greatest burden. however, the health ministry also has authorized including expensive interventions that are less effective or treating health conditions with low prevalence, if that condition or those interventions signifi cantly impact health. because of budget reductions, a number of interventions are under review. your team has been asked to recommend funding interventions for two health conditions-cataract (a common condition with highly effective treatment ) and multiple sclerosis (a less prevalent condition but one with signifi cant health and social impact). cataract, the main cause of blindness, primarily affects people over . this health problem has a high impact as measured by quality-adjusted life years (qalys) (ministerio de salud ) . its surgical treatment is effective for - % of patients. the package of guaranteed interventions includes diagnostic confi rmation within days after suspected diagnosis and surgical treatment days after confi rmation. in , it was expected that , cataract surgeries would be performed in chilean public hospitals and in private institutions. multiple sclerosis , an autoimmune infl ammatory disease leading to demyelination in the central nervous system, produces a progressive deterioration of health and quality of life. it represents a minimal disease burden at the population level, mainly due to premature death. in chile, it is estimated that patients are treated for multiple sclerosis each year. the package of guaranteed interventions includes diagnostic confi rmation within days; confi rmed cases must receive treatment within days. treatment includes pharmacological therapy and p hysiotherapy. contingency arrangements. to make the best use of resources and personnel (even in the absence of a pandemic), patients are triaged-evaluated to determine the type and priority of care to be received. while medical information informs the development of triage criteria, ethical considerations about triage goals-whether explicit or implicit-also play a role. for public health emergencies that overwhelm capacity, some propose adjusting critical care triage criteria to emphasize certain public health goals, like saving the most lives possible (christian et al. ; silva et al. ) . some contend that utilitarian reasoning should predominate in critical care triage, based on the intuition that, when resources are scarce, allocation decisions should produce the greatest good for the greatest number (charlesworth ; childress ) . critics of utilitariani sm reply that it requires coercion or covertness to succeed, because the public will not voluntarily sacrifi ce their lives or their loved ones for the greater good (baker and strosberg ). utilitarian triage may be unpalatable to the public on the further ground that it quantifi es and judges the value of one life over another, which could disproportionally impact particular population groups (hoffman ). others therefore would base triage decisions on egalitarian considerations, for instance, by giving everyone an equal chance at obtaining a scarce good, an approach for which historical precedent exists (baker and strosberg ) . whatever approach is adopted, prior arrangements between policy makers, practitioners, and the public based on thoughtful, transparent deliberation about the most ethical approach to ccu triage usually will improve the legitimacy of d ecisions. those who promote an approach based on fairness and equity need to consider that, during public health emergencies, the goal of saving lives may force a retreat to utilitarian ethics (kirkwood ; veatch ) . while not necessarily unethical in itself, a retreat that overturns prior arrangements lays itself open to charges of illegitimacy. variability in the frameworks used to allocate public health resources illustrates the importance of refl ecting upon the value s that undergird policy decisions and individual practices, like critical care triage. appealing spontaneously in the heat of the moment to values that have not been adequately refl ected upon or discussed in a transparent and deliberative manner may lead to undesirable outcomes and accusations of unethical practices. while discussions of ccu triage criteria ultimately concern institutional clinical policy and practice, they refl ect a larger discussion about the overarching public health goals in the face of large-scale, widespread public health emergencies, like pandemics. an outbreak of a novel infl uenza virus has progressed to the point that the world health organization has declared a pandemic. in the pandemic's fi rst wave, hospital capacities were suffi cient to handle the infl ux of pandemic infl uenza patients, whose morbidity and mortality rates mirrored rates for seasonal infl uenza. however, despite a vaccination campaign and other measures, such as ensuring surge capacity, rates of morbidity and mortality associated with the virus have increased drastically during the pandemic's second wave. the resulting increased number of patients needing hospital beds has overwhelmed even the surge capacity of the ccus of a metropolitan city's tertiary care hospitals. to meet this challenge, a teleconference has been scheduled between several members of the hospitals' administration, the ccu directors from each hospital, and public health offi cials involved in leading the jurisdiction's pandemic response. as a public health offi cial who played a central role in developing the pandemic plan for your jurisdiction, you have been included on the call to provide guidance for the pandemic response. during the meeting, a number of ccu directors report that their physicians and nurses are concerned about the type of patients bein g admitted into the ccu. some of the directors see a trend that they suggest is ultimately undermining the effi ciency of the pandemic response. they argue that, as the severity of the pandemic continues to increase, their triage criteria should be modifi ed so as to use ccu resources to save the most lives possible. they worry that admitting those who present with the most need is preventing treatment of those who will benefi t most from ccu admission. "so long as our triage scheme saves the most lives, it is ethically justifiable" a number of them declare. the group takes up the proposal of a ccu director to triage according to sequential organ failure assessment (sofa) scores-which are derived using a tool that determines a patient's organ function and failure rate to predict outcomes (vincent et al. ) . were the pandemic's severity to increase, the group suggests that, in addition to the ccu director's proposal to use sofa criteria, even more inclusion, exclusion, and priority criteria could be added with the goal of saving as many lives as possible. they've proposed exclusion criteria for ccu admittance that include patients with a poor prognosis, patients with other known health issues, and some mention of age cut-offs, to name a few. others involved in the teleconference question whether this is the right approach to take. they argue that, by aiming to save the most lives possible, those who may benefi t less from ccu admission, like older adults or individuals with disabilities, will be unfairly affected. they say, "we should not just aim to save lives, but rather save lives fairly ." as you and your public health colleagues are leading the pandemic response, the hospital administrators and ccu di rectors look to you for a recommendation or decision about how to proceed. . ensuring that the ccu has surge capacity is a common strategy to accommodate an infl ux of patients who have been infected with pandemic infl uenza. (a) does surge capability require alternative critical care triage criteria? (b) if the population's health needs exceed contingency arrangements, should alternative critical care triage criteria be used? (c) how should these decisions be made? (d) what principles, value s, or processes should infl uence these decisions? . what considerations might exist during a pandemic that do not exist in everyday critical care and critical care triage that do or do not support the modifi cation of triage criteria? if pandemic critical care triage requires a unique conceptual framework, what principles ought to be valued in such a framework (e.g. need, equality, utility, effi ciency)? . would the severity of a pandemic ever warrant the use of a utilitarian scheme for critical care triage, given that the public generally fi nds it unpalatable and carrying out such a plan could require coercion? how could an adverse public reaction to coercive or covert measures be mitigated? . in a pandemic, the most seriously ill patients with the lowest probability of being saved might be left untreated because their care would require too many resources with little prospect of recovery. this illustrates a confl ict between the common good and the best interests of individual patients. what other confl icts might arise when triaging in a pandemic? . triage can be used to maximize the number of lives saved with available resources. should we aim to maximize the number of lives or, alternatively, the number of life years saved? this can also give rise to questions about the quality of those lives and years lived. is it ever appropriate to make allocation decisions based on quality of life or life years? ethical issues in recipient selection for organ transplantation priority to the worst off in health care resource prioritization ethical issues in the use of cost effectiveness analysis for the prioritization of health care resources the effi ciency frontier approach to economic evaluation of health-care interventions rationing fairly: programmatic considerations how to achieve fair distribution of arts in " by ": fair process and legitimacy in patient selection just health: meeting health needs fairly setting limits fairly: learning to share resources for health benchmarks of fairness for health care reform qaly maximization and people's preferences: a methodological review of the literature cost-effectiveness in health and medicine morality, mortality: death and whom to save from it toward a broader view of values in cost-effectiveness analysis in health care cost value analysis in health care: making sense out of qlays bureaucratic itineraries in colombia: a theoretical and methodological tool to assess managed-care health care systems autonomía médica y su relación con la prestación de los servicios ?option=com_content&view=article&id= :la-tutela-y-el-derecho-a-la-salud- &cat id= :libros&itemid= . accessed the history and principles of managed competition serie de notas técnicas sobre procesos de priorización de salud: introducción a la serie de priorización explicita en salud why neoliberal health reforms have failed in latin america structured pluralism: towards an innovative model for health system reform in latin america ministerio de salud y protección social, colombia managed competition for the poor or poorly managed competition? lessons from the colombian health reform experience los actores e intermediarios del sistema de salud en colombia gerentes de hospitales públicos y acreditación en salud the exportation of managed care to latin america barriers of access to care in a managed competition model: lessons from colombia nebraska appleseed-cases of denial of behavioral health coverage for children are needed take advantage of new opportunities to expand medicaid under the affordable care act: a guide to improving health coverage and mental health services for low-income people, following the supreme court ruling on the affordable care act schools, skills, and synapses the rate of return to the high/scope perry preschool program medicaid expansion fact sheet lawsuit fi led to protect the rights of nebraska children with autism and development disability nebraska legislature. . floor debate on lb mental health surveillance among children -united states no health without mental health coverage decision-making in medicaid managed care: key issues in developing managed care contracts phillips, and committee on integrating the science of early childhood development; board on children, youth, and families; institute of medicine; division of behavioral and social sciences and education title : public health and welfare. u.s.c.a § d(a)( )(b) (west ) and u.s.c. § d (r)( ) the mental health parity and addiction equity act of mental health: facing the challenges, building solutions global public-private partnerships: part i-a new development in health? global public-private partnerships: part ii-what are the health issues for global governance? the potential effect of temporary immunity as a result of bias associated with healthy users and social determinants on observations of infl uenza vaccine effectiveness; could unmeasured confounding explain observed links between seasonal infl uenza vaccine and pandemic h n infection? why corporate power is a public health priority an ethics framework for public health balancing the benefi ts and risks of public-private partnerships to address the global double burden of malnutrition can the food industry play a constructive role in the obesity epidemic public health: ethical issues principles of the ethical practice of public health. http:// phls.org/cmsuploads/principles-of-the-ethical-practice-of-ph-version- . - a role for public-private partnerships in controlling neglected diseases? investing in america's health: a state-by-state look at public health funding and key health facts predictors of knowledge of h n infection and transmission in the u.s. population coca-cola supply chain helps bring diarrhoea treatments to developing world the corporate play book, health and democracy: the snack food and the beverage industry's tactics in context about cdc's offi ce of minority health & health equity (omhhe) understanding the determinants of the complex interplay between cost-effectiveness and equitable impact in maternal and child mortality reduction infant deaths-united states the challenge of infant mortality: have we reached a plateau? disadvantage, inequality, and social policy population health: challenges for science and society oecd health data: infant mortality social justice: the moral foundations of public health and health policy hhs action plan to reduce racial and ethnic health disparities difference principles born too soon: the global action report on preterm birth levels and trends in child mortality priority setting in healt h care: ethical issues m. inés gómez and lorna luco centro de bioética, facultad de medicina clínica alemana-universidad del desarrollo what are some of the ethical, scientifi c, and social considerations that should be weighed in deciding if interventions for both cataract and multiple sclerosis should be covered by the system of guarantees in health? is there an obligation for health systems to cover all health problems affecting a population? are there limits? how should health problems be prioritized and who should have the authority to make these decisions? which criteria should receive the most weight in ranking priorities? how should resources be distributed among health conditions affecting many people versus health conditions affecting few people? how should resources be distributed among procedures that are preventive versus treatments for existing conditions? how does taking a public health perspective versus a clinical medicine perspective affect your thinking about including these two conditions in the system of guarantees in health? what role should transparency play in the selection procedure? references burrows establece un régimen general de garantías en salud estudio carga enfermedad y carga atribuible decreto supremo no. . aprueba garantías explícitas en salud del régimen general de garantías en salud towards universal health coverage: the chilean experience , background paper case : critical care triage in pandemics smith dalla lana school of public health and the triage and equality: an historical reassessment of utilitarian analyses of triage. kennedy institute of bioethics in a liberal society disaster triage development of a triage protocol for critical care during an infl uenza pandemic allocating ventilators during largescale disasters-problem, planning, and process preparing for disaster: protecting the most vulnerable in emergencies in the name of the greater good? pandemic triage: the ethical challenge mechanical ventilators in us acute care hospitals contextualizing ethics: ventilators, h n and marginalized populations department of health and human services priority setting for pandemic infl uenza: an analysis of national preparedness plans disaster preparedness and triage: justice and the common good scoring systems for assessing organ dysfunction and survival addressing ethical issues in pandemic infl uenza planning: discussion papers the authors thank student chelsea williams for her assistance in assembling the facts of the case. we also thank creighton university's center for health policy & ethics. acknowledgements we thank mr. jonathan whitehead for language editing. open access this chapter is distributed under the terms of the creative commons attribution-noncommercial . license ( http://creativecommons.org/licenses/by-nc/ . / ) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. the images or other third party material in this chapter are included in the work's creative commons license, unless indicated otherwise in the credit line; if such material is not included in the work's creative commons license and the respective action is not permitted by statutory regulation, users will need to obtain permission from the license holder to duplicate, adapt or reproduce the material. this case is presented for instructional purposes only. the ideas and opinions expressed are the authors' own. the case is not meant to refl ect the offi cial position, views, or policies of the editors, the editors' host institutions, or the authors' host institutions. infectious diseases such as pandemic infl uenza and severe acute respiratory syndrome (sars) have attuned the attention of policy makers and health practitioners to the importance of protecting and promoting the public's health in the face of increased care needs and extreme resource scarcity. in particular, acute care needs for the critically ill and discussions of treatment priorities have been the subject of much debate in pandemic planning (hick et al. ; melnychuk and kenny ; uscher-pines et al. ). this is not surprising, as it has been estimated that more than , americans may require mechanical ventilation during a pandemic, far outnumbering available ventilators (rubinson et al. ; u.s. department of health and human services ) . additionally, shortages of hospital beds, personnel, and other equipment can be expected during a pandemic, which may limit the ability to meet an expected increase in patient volu me (world health organization ).prudentially planning for the public's increased care needs during a pandemic requires assessing surge capacity, especially in critical care units (ccu). however, as pandemics increase in severity, they can overwhelm critical care capacity and key: cord- - pvg apl authors: titov, nickolai; dear, blake f; nielssen, olav; wootton, bethany; kayrouz, rony; karin, eyal; genest, ben; bennett-levy, james; purtell, carol; bezuidenhout, greg; tan, rheza; minissale, casey; thadhani, priti; webb, nick; willcock, simon; andersson, gerhard; hadjistavropoulos, heather d; mohr, david c; kavanagh, david j; cross, shane; staples, lauren g title: user characteristics and outcomes from a national digital mental health service: an observational study of registrants of the australian mindspot clinic date: - - journal: lancet digit health doi: . /s - ( ) - sha: doc_id: cord_uid: pvg apl background: interest is growing in digital and telehealth delivery of mental health services, but data are scarce on outcomes in routine care. the federally funded australian mindspot clinic provides online and telephone psychological assessment and treatment services to australian adults. we aimed to summarise demographic characteristics and treatment outcomes of patients registered with mindspot over the first years of clinic operation. methods: we used an observational design to review all patients who registered for assessment with the mindspot clinic between jan , , and dec , . we descriptively analysed the demographics, service preferences, and baseline symptoms of patients. among patients enrolled in a digital treatment course, we evaluated scales of depression (patient health questionnaire- [phq- ]) and anxiety (generalized anxiety disorder -item scale [gad- ]), as primary measures of treatment outcome, from the screening assessment to post-treatment and a month follow-up. the kessler psychological distress -item plus scale was also used to assess changes in general distress and disability, and course satisfaction was measured post-treatment. outcomes: a total of screening assessments were started, of which ( · %) were completed. the mean age of patients was · years (sd · ) and ( · %) were women. based on available assessment data, ( · %) of participants had never previously spoken to a health professional about their symptoms, and most people self-reported symptoms of anxiety ( [ · %] of ) or depression ( [ · %] of ), either alone or in combination, at baseline. patients started treatment in a therapist-guided online course, of whom ( · %) completed treatment (≥four of five lessons). key trends in service use included an increase in the proportion of people using mindspot primarily for assessment and information, from · % in to · % in , while the proportion primarily seeking online treatment decreased, from · % in to · % in . effect sizes and percentage changes were large for estimated mean scores on the phq- and gad- from assessment to post-treatment (phq- , cohen's d effect size · [ % ci · – · ]; and gad- , · [ · – · ]) and the month follow-up (phq- , · [ · – · ]; and gad- , · [ · – · ]); proportions of patients with reliable symptom deterioration (score increase of ≥ points [phq- ] or ≥ points [gad- ]) were low post-treatment (of respondents, [ · %] had symptom deterioration on the phq- and [ · %] on the gad- ); and patient satisfaction rates were high ( [ · %] of respondents would recommend the course and [ · %] of reported the course worthwhile). we also observed small improvements in disability following treatment as measured by days out of role. interpretation: our findings indicate improvement in psychological symptoms and positive reception among patients receiving online mental health treatment. these results support the addition of digital services such as mindspot as a component in contemporary national mental health systems. funding: none. mental disorders and substance use disorders are major contributors to the burden of disease in australia and worldwide, , with only a minority of those affected see king or receiving evidence-based treatments. , barriers to care include stigma, cost, and availability of services. the covid- pandemic has created additional challenges, as many traditional mental health providers stopped pro viding face-to-face service. as a result, interest is increasing in the digital delivery of psycho logical services. digital mental health services (dmhs) remotely deliver mental health information, assessments, and treatment, via the internet, telephone, or other digital channels. dmhs are already part of routine care in several coun tries, operating either as stand-alone services or in con junction with traditional face-to-face care. , for example, the improving access to psychological therapies (iapt) service of the national health service (england) provides both faceto-face and digital services to patients with anxiety or dep ression; a stepped-care approach that allows patients to move from low-intensity intervention (such as guided self-help) to high-intensity intervention (tradi tional face-to-face therapy). stepped care is not a common feature of stand-alone dmhs, in which patients often report being un willing or unable to access traditional face-to-face therapy. in this paper, we report outcomes from the australian mindspot clinic, which by volume of patients, is one of the world's largest publicly funded dmhs. the mindspot project was launched in december, , and is funded by the australian department of health as part of the australian government's e-mental health strategy. mindspot provides information about symptoms and local mental health services, brief psychological assess ments, and therapist-guided treatments delivered via the internet and telephone to adults with symp toms of anxiety, dep ression, or chronic pain. we have previously reported results from months and months of operations, characteristics of service users during the covid- pan demic, and treatment outcomes for specific populations, including aboriginal and torres strait islander (indig enous) people and people born overseas. in this paper, we aimed to provide a summary of demographic charac teristics and treat ment outcomes for patients registered with mindspot over its first years of operation, including service use and symptom severity, and examined trends in these characteristics over time. this study was designed as an observational study and is reported according to strobe guidelines. we evaluated all patients who registered for assessment or treatment with the mindspot clinic between jan , , and dec , . ethical approval for the collection and use of patient data was obtained from the macquarie university human research ethics committee (macquarie university, sydney, nsw, australia; approval number ) and registered on the australian and new zealand clinical trials registry, actrn . mindspot is funded by the australian government as a project and recruitment is ongoing as patients continue to access the service. as mindspot is funded by the australian department of health, patients seeking assessment or treatment must complete an online registration questionnaire and meet the following eligibility criteria: australian resident eligible for publicly funded health services (ie, medicare-funded services); aged years or older; and self-reported principal complaint of anxiety, depression, or chronic pain. patients are also provided with the terms of use explaining that non-identifiable, aggregated data could be used for reporting and service evaluation purposes. patients are required to consent to the terms this study describes the characteristics and treatment outcomes of a large sample of consecutive users (n= ) of the national australian dmhs, mindspot clinic, from data collected over its first years of operations. we provide information about the demographic characteristics, service preferences, symptoms, and treatment outcomes for people using this particular model of digital service. we found that clinic users represented a broad cross-section of the australian population, and used mindspot for a variety of reasons, with most seeking a confidential assessment rather than treatment. we also found that people who engaged in treatment achieved significant reductions in symptoms, which were sustained months after treatment completion. importantly, these findings confirm the role of dmhs in providing evidence-based assessment and treatment to large numbers of people, many of whom are not accessing other services. the present findings contribute to the evidence base for dmhs in reducing barriers to care, and confirm the utility of dmhs as an important component of contemporary mental health systems. of use, either online or by telephone, before proceeding with assessment and treatment. the people register with mindspot by creating an account and completing a screening assessment, online or by telephone. the screening assessment includes questions on demographic and service use information, and symptoms and current stressors. participants are also asked about suicidal thoughts and plans. those who disclose suicidal plans or intent and who can subsequently be contacted by telephone are administered a structured risk assessment aligned with the new south wales government best practice guidelines, and safety plans are developed for all users to assist them to stay safe while seeking treatment or in the event of an increase in symptoms during treatment. those unable to be contacted are referred to local police for a welfare check. people who continue to express suicidal intent are referred to local mental health services or emergency services, depending on the urgency of the situation. however, patients with suicidal thoughts can also continue to access mindspot services if they agree to a safety plan. mindspot operates under compre hensive internal and external oversight and reporting that includes clinical, organis ational, and infor mation technology governance frameworks. the clinical governance frameworks align with australian national standards for mental health services and include policies, systems, and protocols for identifying patients or others at risk, their management, clinical escalation in the event of increased risk, and training and supervision of staff. people who do not complete an assessment are sent information about managing symptoms, contact details for crisis services, and are invited to contact mindspot. people who complete the assessment are invited to discuss their results with a therapist by tele phone (appendix p ), who provides tailored advice over the appointment of approxi mately min. an assess ment report that identifies clinically significant symptoms and includes information about how to access mental health services (including those offered by mindspot) or other services, is sent by the therapist to the patient and, if requested by the patient, to a nominated health pro fessional, usually a general practitioner. information is also provided about evidence-based techniques for self-managing symp toms. participants who complete an assessment and elect for a mindspot digital treatment course are then enrolled, unless they are considered ineligible for digital treatment by the therapist because their clinical presentation suggests the need for compre hensive or urgent face-to-face assessment. those cases are sup ported to access specialist services. mindspot delivers seven digital treatment courses, which were developed and validated in a series of randomised controlled trials at the macquarie university online research clinic, the ecentreclinic. four of the treatment courses are based on transdiagnostic principles recognising that people often experience symp toms of anxiety and depressive disorders simul taneously, and that similar psychological skills are used to treat these symptoms. the four transdiagnostic courses offered by the mindspot clinic are mood mechanic (for individuals aged - years), the wellbeing course ( - years), wellbeing plus (> years), and the indigenous wellbeing course (for aboriginal and torres strait islander people). , [ ] [ ] [ ] [ ] these four interventions comprise evidencebased psychological treatment components, including psycho education about mediators and moderators of symptoms, cognitive therapy, behavioural activation, graded exposure, sleep training, communication and inter personal skills, problem solving, and relapse prevention. , mindspot also offers disorder-specific courses for obses sive compulsive disorder, post-traumatic stress disorder, and chronic pain. patients can choose a treatment course based on symptoms and demo graphic characteristics, and via telephone consul tation with a mindspot therapist. all courses consist of five lessons delivered over weeks. each lesson comprises a series of slides that presents the principles of psychological treatment for the target symp toms via text and images, based on an instructional design that accommodates both didactic and case-based learning. course completion is defined as completion of four or more lessons. courses are delivered online with regular support initiated from the therapist once a week, either via telephone, secure email, or both. the therapist is also available at any time throughout the course. the approximate amount of therapist time per patient per course ranges from around · h to h. therapist time includes all contact with patients, pre paration time for each patient including reading and responding to messages, and administration for the ecentreclinic see www.ecentreclinic.org for the australian department of health national standards for digital mental health services see https://www. safetyandquality.gov.au/ standards/national-safety-andquality-digital-mental-healthstandards see online for appendix and super vision time during treatment and during follow-up. course materials are available online, although around % of people elect to receive materials via a printed workbook, sent by postal mail. in addition to the therapist-delivered treatment courses, a month trial of telephone-based counselling was conducted in , and a self-guided version of the wellbeing course was introduced in , the results of which will be reported elsewhere. standardised and validated symptom questionnaires are administered to patients at the screening assessment and throughout treatment. for the purposes of this study, treatment out comes on the patient health questionnaire- (phq- ), generalized anxiety disorder -item scale (gad- ), and kessler psychological distress -item plus scale (k- +) were analysed as treatment outcomes. the phq- consists of nine items measuring symptoms of major depressive disorder according to criteria of the diagnostic and statistical manual of mental disorders, th edition. scores range from to , with a score of or more indicating a diagnosis of depression. the gad- consists of seven items and is sensitive to the presence of generalised anxiety disorder, social phobia, and panic disorder. scores range from to , with a score of or more indicating the probable presence of an anxiety disorder. the k- + was used as a secondary outcome measure to assess general psychological distress and disability. the first ten items comprise the kessler psychological distress -item scale (k- ), with scores ranging from to and scores of or more associated with the presence of anxiety and depressive disorders. the k- + contains four additional questions used to assess the functional effect of the psychological distress. in the current analysis, we used two of the additional questions to assess the number of full and part days a person had been out of role (unable to do usual duties and activities) in the past month. we also report the quantifiable k- score. patients are admin istered the phq- and gad- at the screening assessment, once a week during treatment (days , , , , , , and ), post-treatment (day ), and at a month follow-up (day ). patients complete the k- + at the screening assessment, the start of treatment (day ), midtreatment (day ), post-treatment (day ), and the month followup (day ). patients also complete a satisfaction questionnaire post-treatment. the satis faction questions we report on are: "would you recommend this course to others?" and "was it worth your time doing this course?" all questionnaires are delivered online and patients have weeks to complete the post-treatment and follow-up questionnaires before they are considered closed. we did descriptive analyses of demographics, service preferences, and baseline symptoms for the total sample and for each year. for categorical variables, χ² analyses of linear-by-linear associations were used to examine trends with time. anova was used to examine the significance of changes to continuous variables with time. χ² values represent changes in categorical variables over time, and f-values from anova represent significant differences in dependent variables, with years as the independent variable. generalised estimating equation (gee) models with wald's χ² as the test for significance were used to examine changes in symptom measures from assessment to post-treatment and the month follow-up. con sis tent with the principles of intention-totreat analy ses, we imputed missing data for all patients starting treatment, using separate gee models that assumed data were missing at random, and adjusted for baseline symptoms and lesson completion. an unstructured working correlation matrix and maximum likelihood estimation were used, and gamma distribution with a log link response scale was specified to address positive skewness in depen dent variable distributions. we calculated the clinical significance of change in phq- , gad- , and k- measures using per centage change in symptoms from baseline and within-group cohen's d effect sizes, based on the esti mated marginal means derived from gee modelling at the screening assessment, post-treatment, and the month follow-up. reliable recovery was calculated as the proportion of patients whose scores were higher than the clinical cutoffs of primary measures (phq- ≥ or gad- ≥ ) at assess ment and lower than the cutoffs post-treatment, with evidence of reliable change. reliable change was defined as a change of at least points on the phq- and at least points on the gad- . , reliable deter ioration in patients who completed treatment was defined as a score increase of at least points on the phq- and at least points on the gad- post-treatment. data were analysed with spss (version . ). a significance level of · was used for all tests, with the bonferroni correction applied for multiple comparisons. there was no funding source for this study. during the first years of clinic operation from jan , , to dec , , a total of online screening assessments were started, of which ( · %) were completed (figure). the number of people starting an assessment at mindspot increased consistently from to , and subsequently plateaued at around per annum as directed by funding contracts. a breakdown of completed assessments by year is available in the appendix (p ). demographic characteristics of the total sample and by year, representing all those who started the screening assessment, are shown in table . the mean age of patients in the total sample was · years (sd · ) and ( · %) were women. during the years of clinic operation, small but significant changes were observed in the age, sex, indigenous status, employment, education, and mar ital status of people initiating an assessment. for age, we observed a slight increase in the proportion of people aged - years with time, and less change in the proportion aged years and older (appendix p ). the proportion of women fluctuated between · % and · %, and the proportion of people married decreased from · % in to · % in . the proportion of patients born in australia remained around · %, while the proportion identifying as aboriginal or torres strait islander increased from · % in to · % in . we observed some change in employment status over time, particularly in the proportion of students ( · % in to · % in ), and a concurrent increase in the proportion of people with a university degree ( · % to · %). the proportion of patients living outside capital cities remained relatively stable ( · % for the total sample of - ). proportions of patients from each state and territory are shown in the appendix (p ). almost a third of respondents were from new south wales. reported psychological symptoms and stressors at the time of the screening assessment by year are shown in table . in years of clinic operation, significant fluctuations were observed in symptoms. mean scores at assessment (baseline) on the phq- decreased from · (sd · ) in to · ( · ) in , with a con current decrease in the proportion of people self-reporting current difficulties with depression during that period. mean baseline scores on the gad- remained close to the mean for the whole period ( · [ · ]; with the exception of · in the first year), although the pro portion reporting anxiety or worry increased over the years. mean baseline k- scores decreased slightly, from · ( · ) in to · ( · ) in . based on a series of questions specifically about suicidal thoughts, intentions, and plans, the proportion of people reporting thoughts relating to suicide fluctuated between · % and · %, while the proportion reporting both suicidal thoughts and current intent or a plan increased from · % in to · % in . signi ficant changes over time were also observed in reported psycho social stressors. the proportion of people repor ting relationship difficulties increased, while the pro portions of people reporting vocational, physical health, or financial difficulties decreased (table ) . service use and preferences by year are reported in table . significant changes were observed in the main reported purpose of using mindspot among patients during the first years of clinic operation. from to , the proportion of people using mindspot primarily for assessment and infor mation increased from · % in to · % in , while the prop ortion primarily seeking online treatment decreased, from · % in to · % in . table also reports the reasons participants gave for using an online service rather than a face-to-face service. since intro duction of the question in , around a third of respondents consistently reported convenience and (absence of) cost, and another third reported privacy and anonymity as their main reason. over years, · % to · % patients reported that they had never previously seen a mental health professional. · % to · % patients reported speaking to a general practitioner about their mental generalized anxiety disorder -item scale kessler psychological distress -item scale data are mean (sd) or n/n (%), where numerators are the number of positive responses and denominators are the number of patients who provided an answer to that question. *questions introduced july, . †questions regarding the duration of symptoms (anxiety or depression > months) were introduced sept, ; for both, the denominator is the number of people who reported current relevant symptoms and provided a response to the duration question. ‡missing data for the last quarter of due to system changes. gee analyses showed significant overall symptom reductions in phq- (wald's χ²= · , p< · ), gad- (wald's χ²= · , p< · ), and k- (wald's χ²= · , p< · ). pairwise comparisons showed that scores on all measures decreased significantly from assessment to post-treatment and from assessment to follow-up (all p< · ). analyses of the clinical significance of treatment outcomes by year revealed consistent results, with symptom reductions post-treatment for all years on all measures (appendix pp - ). this study described the demographic characteristics, service preferences, and symptoms of more than users of a national dmhs, collected during years of clinic operations. users of the service repre sented a broad cross-section of the australian popu lation, many of whom were seeking a confidential assessment rather than treatment. those who did engage in treat ment achieved significant reductions in symptoms that were sustained for up to months. the results confirm the efficacy and efficiency of mindspot in provi ding evidence-based assessment and treatment to large numbers of people, data are n/n (%), where numerators are the number of positive responses and denominators are the number of patients who provided an answer to that question. *missing data from july to dec, , due to system changes. †data available from july, . ‡question introduced april, ; missing data for due to system changes. table : mental health service preferences and use at assessment many of whom are not accessing other services. our findings contribute to the evidence in support of dmhs within contemporary mental health systems. consistent with reports before , , mindspot has continued to serve a broad and geographically dispersed cross-section of the australian population. some changes in demographics and symp toms have occurred with time, including an increase in the proportion of young adult users, an increase in the proportion identifying as aboriginal or torres strait islander, and an increase in people reporting anxiety. a key observation was the increase in proportions of people reporting a primary purpose for contacting mindspot was to receive an assessment rather than treatment. many patients reported to therapists that a confidential assessment was the only intervention required at the time of consultation. this finding suggests that a dis cussion with a therapist about the nature of symptoms and treatment options is valued by many people, and can serve as a brief therapeutic intervention in itself. the data also raise important questions about engagement and attrition in digital and traditional mental health services, and whether all patients accessing a service can be assumed to be treatment-seeking. these results confirm our view that dmhs should align with patient-centred models of care, and offer a range of services, including education, assessment, triage, support to access urgent help for people in crisis, and referral, as well as providing evidence-based treatment. with regard to treatment outcomes, the overall magnitude of clinical improvements obtained across the mindspot treatment courses remain consistently high, with greater than % symptom reductions in anxiety and depression post-treatment, which were sustained for up to months. outcomes compare favourably with bench marks relating to substantial clinical improvement, low rates of deterioration, and high patient satisfaction with dmhs in other countries, including when offered in primary care, and via other initiatives for large-scale implementation of psychological treatment in australia and the uk. this study has several limitations. we report on characteristics and outcomes of patients registering for assessment or treatment with mindspot, which restricted our sample to a small proportion of visitors to the mindspot website (> per year), and limits the generalisability of our results. we also acknowledge the issue of missing responses, which is a limitation of many studies, particularly those reporting outcomes obtained in routine care, in which patients are receiving a service rather than participating under controlled trial con ditions. the absence of a control group also means that we are unable to account for natural remission or the effect of missing data. however, this limitation was mitigated by the weekly collection of symptom scores during treatment and by conservative statistical modelling, and we found no indication of systematic bias in trends over time due to missing data. a post-hoc analysis did find some evidence that young patients and those with severe symptoms are not necessarily continuing to or completing treatment (appendix p ), which might affect the generalisability of our results. generally, we found that several key demographic factors, such as the proportion of people born overseas, distribution by states and territories, indigenous status (aboriginal and torres strait islander), and proportion living in rural or remote regions, closely matched national statistics. however, we acknowledge that other factors might be under-represented or over-represented in our sample. for example, the proportion of men contacting mindspot was always less than %, an underrepresentation consistent with reports that men are less likely to seek help for anxiety and depression from traditional mental health services, despite having higher rates of suicide than women. , the question of how to engage men in both traditional mental health services and dmhs remains important and might require new service models. despite these limitations, our results show that a high-volume digital mental health service can be successfully implemented as part of routine care. the main stren gths of this study are the analyses of comprehensive data on a large consecutive sample, combined with the regular measurement of symptoms to monitor treatment effects. furthermore, treatment results over years match those reported in earlier papers, confirming the robust nature of the digitised clinic procedures and clinical effects. as of , mindspot has been operating for more than years. in that time, the delivery of health care, including some forms of mental health care, via digital technology has become increasingly acceptable. services such as mindspot have shown that digital deli very of care increases accessibility and convenience for patients and can reduce other barriers to care such as stigma. other key learnings from mindspot are that dmhs could have an important role in contem porary mental health care, not only by providing treat ment, but also by providing infor mation and assessment services to diverse groups of people that often under-utilise traditional health services, including indigenous australians, and people living in rural and remote regions. , we maintain that dmhs are not a panacea and should not replace existing services, but instead can complement those services by reducing barriers and delivering evidence-based care to large numbers of patients in an efficient and cost-effective way. , people who do not respond to dmhs can then be supported to seek more intensive treatment, consistent with a stepped-care approach. an important feature of dmhs is the potential for systematic measurement of progress via treatment and outcomes, which is rarely implemented with existing service models. by providing services to large numbers of people and routinely collecting and reporting data about user characteristics and clinical outcomes, dmhs are not only providing valuable benchmarking data, but are having a growing influence on the planning of mental health systems across an increasing number of countries. the routine collection and reporting of user data, with the exception of the uk's iapt model, is not typical of publicly funded psychological services. thus, such reporting by dmhs is not only increasing unde rstanding among policy makers on the relative strengths and limitations of different service models, but is likely to lead to increased expectations from funders and policy makers for similar reporting from traditional services. in the long term, this influence might lead to policy and funding decisions based more on evidence than traditional practice, but in the short term this will require change in the culture and operations of services that do not routinely collect or report these kind of data. developing, delivering, and evaluating dmhs is challenging, requiring complex procedures and ongoing evaluation in the context of ever-changing technology and a rapidly evolving governance and regulatory envi ronment. despite the challenges, we no longer need to question whether dmhs will become part of the frame work of mental health services. the new question is, how will this integration occur and how do we best integrate dmhs with existing face-toface services? based on the preferences of many patients for more easily accessible, confidential mental health care, we believe that a need will be ongoing for stand-alone services, which provide the option of assessment and treatment and are not always linked with an existing provider. ideally, existing mental health services should receive support to deliver both face-toface and digital mental health care, and we strongly recommend engagement during the development and implementation of these services with patients and other stakeholders, including policy makers and funders, to ensure that services are not only effective but also acceptable. mental health professionals could then be trained and equipped to use digital tools with their own clients, to improve both quality of care and collection of treatment outcome data. without such training and support, patients are unlikely to receive consistently high-quality care, and funders are unlikely to receive data on clinical outcomes to guide service or programme improvements. the mindspot project has become one of the leading providers globally of dmhs as part of routine care and has deli vered mental health services with proven effectiveness to a large number of australians in its first years. the consistency of results provides support for the adoption of this model of care within the national mental health system, particularly in the present context of increased consumer acceptance of digital and telephone health-care services. nonetheless, we maintain that the role of dmhs is to provide consumers and referrers with an additional choice of service model. the prevalence and burden of mental and substance use disorders in australia: findings from the global burden of disease study addressing mental health needs: an integral part of covid- response global, regional, and national incidence, prevalence, and years lived with disability for diseases and injuries for countries, - : a systematic analysis for the global burden of disease study estimating treatment rates for mental disorders in australia has increased provision of treatment reduced the prevalence of common mental disorders? review of the evidence from four countries barriers to mental health treatment: results from the national comorbidity survey replication advantages and limitations of internetbased interventions for common mental disorders from research to practice: ten lessons in delivering digital mental health services transparency about the outcomes of mental health services (iapt approach): an analysis of public data the first months of the mindspot clinic: evaluation of a national e-mental health service against project objectives australian government department of health and ageing mindspot clinic: an accessible, efficient and effective online treatment service for anxiety and depression rapid report: early demand, profiles and concerns of mental health users during the coronavirus (covid- ) pandemic a comparison of indigenous and non-indigenous users of mindspot: an australian digital mental health service a comparison of the characteristics and treatment outcomes of migrant and australian-born users of a national digital mental health service the strengthening the reporting of observational studies in epidemiology (strobe) statement: guidelines for reporting observational studies mental health triage policy procedures for risk management and a review of crisis referrals from the mindspot clinic, a national service for the remote assessment and treatment of anxiety and depression transdiagnostic versus disorder-specific and clinician-guided versus self-guided internet-delivered treatment for generalized anxiety disorder and comorbid disorders: a randomized controlled trial disorder-specific versus transdiagnostic and clinician-guided versus self-guided treatment for major depressive disorder and comorbid anxiety disorders: a randomised controlled trial internet-delivered treatment for older adults with anxiety and depression: implementation of the wellbeing plus course in routine clinical care and comparison with research trial outcomes internet-delivered treatment for young adults with anxiety and depression: evaluation in routine clinical care and comparison with research trial outcomes the phq- : validity of a brief depression severity measure a brief measure for assessing generalised anxiety disorder: the gad- anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection short screening scales to monitor population prevalences and trends in non-specific psychological distress primary mental health care minimum data set. scoring the kessler- plus to gee or not to gee: comparing population average and mixed models for estimating the associations between neighborhood risk factors and health wish you were here": examining characteristics, outcomes, and statistical solutions for missing cases in web-based psychotherapeutic trials measurement of symptom change following web-based psychotherapy: statistical characteristics and analytical methods for measuring and interpreting change the first months of the mindspot clinic: evaluation of a national e-mental health service against project objectives icbt in routine care: a descriptive analysis of successful clinics in five countries evaluation of the practitioner online referral and treatment service (ports): the first months of a state-wide digital service for adults with anxiety, depression, or substance use problems australia's better access initiative: an evaluation the australian version of iapt: clinical outcomes of the multi-site cohort study of newaccess why are australia's suicide rates returning to the hundred-year average, despite suicide prevention initiatives? reframing the problem from the perspective of durkheim the cost-effectiveness of the online mindspot clinic for the treatment of depression and anxiety in australia the mindspot clinic is a project funded by the australian government. the authors gratefully acknowledge the patients for allowing the use of their data and the efforts of staff at macquarie university (access macquarie, mq health, mindspot clinic, and ecentreclinic) in launching and operating the clinic. all authors contributed equally to the manuscript. nt and bfd are authors and developers of the treatment courses used at the mindspot clinic but derive no personal or financial benefit. bw coauthored the obsessive compulsive disorder course used at the mindspot clinic with nt and bfd but derives no personal or financial benefit. nt serves as chair of an expert advisory group appointed to support the australian commission for safety and quality in health care to develop a national standards and certification framework for digital mental health services. all other authors declare no competing interests. access to de-identified data might be provided on reasonable request. requests are subject to the establishment of appropriate data governance, and the approval of an independent and recognised human research ethics committee. requests must be made in writing to dr lauren staples, mindspot clinic, macquarie university, sydney, nsw , australia (lauren.staples@mq.edu.au). key: cord- - fgtjouu authors: hutton, thomas a title: service industries, globalization, and urban restructuring within the asia-pacific: new development trajectories and planning responses date: - - journal: prog plann doi: . /s - ( ) - sha: doc_id: cord_uid: fgtjouu while industralization programmes have been central to the development of asia-pacific states and city-regions over the past half-century, service industries are increasingly important as instruments of urban growth and change. the purpose of this paper is to establish service industries as increasingly significant aspects of urban development within the asia-pacific, and to propose a conceptual and analytical framework for scholarly investigation within this important research domain. to this end the paper explores a sequence of related themes and issues, concerning the larger developmental implications of urban services growth (or tertiarization), the facets of urban transformation associated with tertiarization, and a preliminary typology of urban service functions which acknowledges the rich diversity of service vocations and stages of development within the asia-pacific. the paper concludes that “advanced services”—specialized, intermediate service industries, advanced-technology services, and creative service industries—will be quite crucial to the development of city-regions within the asia-pacific, with respect to employment growth and human capital formation, to the urban economic (or export) base, to the operation of flexible production systems, and to competitive advantage. the development of these urban service poles will require innovative policy commitments and regulatory adjustments, as will the multi-centred specialized urban service corridors which function as engines of regional economic growth, and which provide platforms for national modernization and responses to the pressures (and opportunities) of globalization. to date, urban and regional development strategies for service industries within the asia-pacific have privileged globalization, industrial restructuring, and modernization aims, but there is also an encouraging record of more progressive planning experimentation in some jurisdictions, incorporating principles of sustainability and co-operative development. there is also increasing interest in policies to support cultural and creative industries among asia-pacific city-regions, informed by some recent urban policy experimentation in this domain. these experiences can offer models for further policy and programmatic innovation in the st century, as service industries continue to play larger roles in urban and regional development within the asia-pacific. introduction: service industries and urban transformation service industries have accounted for an increasing share of labour, output, and trade among the advanced economies of the organization for economic co-operation and development (oecd) over the last quarter century. this phenomenon of sustained growth in services (both in absolute and relative terms) can be observed at the national level among oecd member countries in terms of the changing composition of gross domestic product (gdp) and employment, but is especially pronounced at the urban or city-region scale. final demand service industries (for example retail, education, and most government services) are strongly tied to large metropolitan consumer markets, while intermediate services are even more spatially centralized, reflecting the influence of urban and agglomeration economies on the locational pattern of specialized, contact-intensive services. following the protracted decline of traditional manufacturing, service industries have led employment growth among most advanced city-regions over the last three decades. but the significance of service industries to urban (and especially metropolitan) development extends beyond measures of growth, as important as these are, to encompass comprehensive processes of change. at the broadest theoretical level we can discern intimate associations between service industries and redefining urban socio-economic processes and stylistic innovation over the past century. the growth of high-rise office complexes was an integral feature of the production of modernist urban landscapes, while advanced service industries have been central to the experiences of post-industrialism, flexible specialization, and post-modernism which have transformed urban landscapes, production sectors, and occupational structures over the past several decades. more particularly, service industries are directly involved in fundamental shifts in the urban economic base and industrial structure, but are also deeply implicated in the reconfiguration of regional structure, the metropolitan space-economy, and urban form. the rapid growth of service occupations among the most advanced post-industrial cities has also had profound implications for urban class structure and for the metropolitan social morphology, and is associated with the evolution of urban culture and even political preferences. in addition to these internal facets of urban transformation, service industries are also influential in the repositioning of cities and city-regions within external networks and systems. growth in urban service exports and trade may be significant in the recasting of city -hinterland relations, and in the reordering of national urban hierarchies, and is quite decisive in the emergence of global city-regions. at the apex of the global city hierarchy the most privileged status is associated with high concentrations of specialized banking and finance, and the projection of corporate power, as well as encompassing a more diversified ensemble of specialized service industries. these far-reaching aspects of urban service growth (or tertiarization) are most pronounced within the mature societies of europe and north america, but are increasingly relevant to an appreciation of urban growth and change within asia-pacific cities. the purpose of this paper is to propose a framework for investigating the influence of service industries on urban development within the asia-pacific, with an emphasis on dimensions of transformational change, both within the metropolis, and at the broader urban systems level. this entails an assessment of economic implications of tertiarization for cities and city-regions within the asia-pacific, including the emergence of new urban functions or vocations, and constituent shifts in the urban economic base, employment structure, and mix of industries. advanced or specialized services-especially, banking and finance, business and trade services, professional and 'informational' service activities, among others-are increasingly associated with modernization aspirations among the region's post-industrial, late-industrial and transitional societies, as reflected in development strategies and programmes. however, the parameters of urban change within the asia-pacific associated with tertiarization extend beyond this economic dimension to encompass impacts of service industry growth on urban structure and form, the built environment, social class and social morphology: i.e. the comprehensive facets of transformation (and re-imaging) of cities increasingly engaged in advanced services production, exchange, trade and consumption. our conceptual point of departure is that the expansion of services activity within asia-pacific cities and city-regions represents not only incremental urban growth and change, but, rather, consequential shifts in the role of urban areas within advanced production systems, in the globalization of trade flows, and in new social divisions of production labour. accordingly, the analytical focus will be on service industries and activities which the research literature has identified as 'propulsive' in urban growth and development; i.e. intermediate (rather than final demand) services, specialized service industries, and knowledge-and technology-based or informational services. at the same time, the record of urban services growth within the asia-pacific region discloses wide variations in stages of services development and mixes of service activity from place to place, and this variegation must be acknowledged in the interests of presenting a more rounded perspective on the experience than an exclusive discussion of leading edge examples would allow. indeed, some of the most interesting and instructive stories of urban tertiarization within the asia-pacific concern the juxtaposition of informal and advanced services in transitional societies, with ensuing social, land use, and planning conflicts. following this introduction, the paper offers a discussion of contrasts in developmental trajectories between the 'mature' atlantic core regions and those of the dynamic pacific core (chapter ), including an acknowledgement of industrialization as the dominant development paradigm for much of the asia-pacific since the s. defining elements of advanced urban tertiarization are identified, and are constituted within a taxonomy of global cities' service functions. the following section (chapter ) addresses both commonalities and contrasts in service industry developments among city-regions of the atlantic and pacific cores, and identifies five principal implications of service growth for urban change within the asia-pacific. these include the role of service industries in reshaping urban development trajectories, in the reconfiguration of urban space, and in urban social and cultural change, as well as the ramifications of accelerated tertiarization for the everyday experiences of city life and for urban identity and image. next, the paper offers a typology of urban services development within the asia-pacific (chapter ), derived from levels of services specialization as well as from urban scale. the spatial development of specialized services production within the asia-pacific is described, including both polarized patterns and more extended territories of tertiary sector growth, observed in the form of incipient urban corridors. these corridors (or clusters) represent a functionally specialized form of territorial development which exhibit features of co-operation as well as competition, and in part express policy responses to the pressures of globalization. the two final substantive chapters address planning issues and experiences associated with the development of the urban service sector. the first (chapter ) describes the basic evolution of local policy responses to urban tertiarization over the last quarter-century, from early development control policy regimes imposed to manage negative externalities of rapid service industry growth, to more balanced approaches, which combined developmental as well as regulatory elements. this chapter concludes with a set of important processes and events which have shaped a new policy environment for urban service industries in the early st century. next, chapter extends this discussion, by introducing a framework of six strategic urban policy models which are deployed in cities within the asia-pacific, including experiments in progressive planning (co-operative regional development, sustainable city-regions), as well as familiar models associated with globalization and restructuring objectives. the paper concludes with suggestions for a research agenda, emphasizing developmental and transformational implications of service industry growth for city-regions within the asia-pacific. there are of course different approaches to conceptualizing the units of 'world geography' apart from the standard continental divisions, as a spectrum of historical, socio-cultural, political and economic considerations can be imposed upon the standard geo-physical patterns. for much of the post-war period the idea of a tripartite structure of spheres organised crudely along ideological lines and developmental progress emerged as a descriptive convention, including a developed, essentially democratic-capitalistic 'first world', comprised of a hegemonic us bloc and its allies in north america, western europe, japan and australia; secondly, the comecon (council for mutual economic aid) group of nations, largely dominated by the ussr and concentrated within eastern europe and asia, but also including cuba; and, finally, a 'third world' of 'developing' countries, ostensibly non-aligned, but including many de facto client states of either the us or the ussr. with the collapse of the 'second' (comecon) world (comecon) world - , and the increasing pluralism within the first and third worlds implied in the post-modern viewpoint, there has been a renewed interest in (re) conceiving global geography or world regional patterns. in this regard lewis and wigen acknowledge the tendency of world regional frameworks "to grossly flatten the complexities of global geography", but assert that "some form of baseline heuristic scheme is necessary for teaching and thinking about metageography" (lewis and wigen, : ) . to this end their conceptual preference is to ignore political and ecological boundaries, and to instead focus upon historical processes, to give primacy to "the spatial contours of assemblages of ideas, practices, and social institutions that give human communities their distinction and coherence" (lewis and wigen, : ) , and to consider not only internal attributes but external relations. see martin w. lewis atlantic core, due in large part to earlier industrialization, and a longer record of tertiarization, but there is now a well-developed pattern of higher-echelon global cities within the asia-pacific (rimmer, ; preston, ) (fig. ) . these cities are centres of advanced industrial and services production, and are linked by capital flows, technology transfer, transportation and communication networks, and patterns of cultural exchange and diffusion, typifying aspects of international and global codependency. the second-order world cities achieve a level of global reach via the presence of certain specialized industry groups, propulsive firms, or influential international institutions, and thus comprise essential elements of the global economy. global city status is conventionally associated with comparative concentrations of intermediate banking and finance, headquarters of mncs, 'producer' services (stanback et al., ) and international gateway functions. however, increasingly global city status encompasses other suites of specialized service industries, including design, knowledge, and technology-based activities, in part reflecting scott's thesis concerning the transformational convergence of culture and urban economic development (scott, ) , as well as the competitive advantage of metropolitan cities for creative and informational services (table ) . this city-centred growth pattern is complemented by complex and distinctive forms of regional development, which include ( ) multi-centred urban growth corridors or 'megalopolitan' regions, such as the classic new york -new jersey conurbation (gottmann, ) , and the randstat urban corridor in the old atlantic core, and the example of the 'extended metropolitan regions ' (mcgee, ) of east asia and southeast asia, such as jakarta -bandung, beijing -tianjin, and tokyo -kawasaki -yokohama, within the asia-pacific sphere; ( ) 'lead regions' comprised of innovative industry complexes and propulsive firm networks, exemplified by baden -württemburg, the veneto, the ile de france, and the london-oxford -cambridge technology triangle within the old core (storper and salais, ) , and the kanto plain, orange county, and silicon valley (scott, ) within the pacific sphere; and ( ) incipient trans-border 'growth triangles' (and other geoeconomic constructs), illustrated by the singapore -johore -riau development triangle, and the cascadia metropolitan bio-region of the pacific north west, and, in the atlantic old core, the transmarche region, and the emerging baltic development zone which aspires to foster mutually beneficial development in northern germany, the former soviet baltic states of latvia, estonia and lithuania, and scandinavia. these new and emerging growth territories may exhibit positive spread effects of regional development generally lacking in less advanced zones table principal suites of specialized service industries for global city-regions i (suites of specialized service functions) banking and finance commercial, merchant, and investment banks; securities and brokerages; stock exchanges; non-depository financial institutions; insurance and re-insurance; industrial-commercial real estate and property development corporate control head offices of international and global corporations and multi-nationals; 'propulsive' corporations and firms producer services specialized, export-capable intermediate service industries and firms; corporate law and accounting firms; management consulting, consulting engineers gateway roles major international airports; major seaports; international telecommunications facilities capital functions national capitals; state/province/regional capitals and administration; offices of international agencies tourism and conventions international tourism and convention industries; major international fairs and expositions advanced-technology services software developers; it firms; internet providers; 'dot.com' firms creative services and applied design architects; industrial design; graphic artists/design; fashion design; interior design; landscape design education and knowledge major national and international universities and colleges; r&d operations and science parks; major 'think tanks' and other research/ knowledge-based institutions culture and heritage major museums and galleries; national libraries and archives; culturally defining heritage buildings, sites, and precincts of the global economy, and suggest possibilities of functional complementarity and reciprocal specialization, as well as the familiar exigencies of competitive advantage. in the aggregate, these characteristics-technology-intensive production, high quality economic infrastructure, productive human and social capital, superior external trade mechanisms and capacity, and the distinctive spatial patterns of growth described above -constitute defining aspects of development within the world's dominant economic spheres. these attributes affirm the exalted economic status of the mature atlantic core and the dynamic pacific core, define the trajectory of development at the leading edge of change and transformation, and suggest the power of convergence, interdependence, and hierarchy acknowledged as important facets of globalization. while important commonalities can be discerned, there are fundamental contrasts in the development experiences and transformational vectors of the atlantic and pacific spheres, as well as innumerable variations in the circumstances and growth paths of individual nations and regions within each of these dominant, supra-continental realms (see yeung and lo, ) . the inexhaustible differentiation of regional histories, political traditions and structures of governance, culture and geographical and environmental factors are seen to underpin the persistence of variegation and exceptionalism among regions and localities within both the old and new cores. the confluence of exogenous forces, including the rise of mnes, and increasing market integration and technological diffusion, has imposed some measure of developmental convergence and commonality across international space (as well as increasing disparities within urban social structures), but there are after all limits to the homogenizing effects of globalization, as the recent scholarly development literature attests. without denying the impressive global sweep of mnes and speculative capital, it is essential to acknowledge the significance of (largely) localized development influences, such as site and environment, the structures of social networks and civic institutions, and the quality of public policy and regulation. in an insightful book aimed at 'reasserting the power of the local', a number of scholars enrich the discourse on globalization by an elucidation of factors which reaffirm the power of local identity, and which provide some friction to the movement of capital and firms. storper, notably, asserts the significance of 'territorialization' in embedding some specialized forms of economic activity within specific locations, beyond the more generic considerations of urban agglomeration which can bind (especially contact-intensive) firms to central places, such as higher-order service enterprises which cluster within the corporate complex of the central business district (cbd). in this interpretation, a firm or activity is "fully territorialized when its economic viability is rooted in assets (including practices and relations) that are not available in many other places and that cannot be easily or rapidly created in places that lack them" (storper, : ) . this concept of territorialization can also incorporate the quality of civic institutions and civil society as influences on economic development and socio-economic welfare, as disclosed in putnam's seminal study of regional and community development in italy (putnam et al., ) . other important factors of locality that can influence differentiation in patterns of economic growth and development are exemplified by amenity attributes, which may include access to education and learning opportunities, and community levels of tolerance and equity, as well as air and water quality, leisure, and recreational opportunities. thus, the forces of globalization, as powerful and pervasive as they demonstrably are, may be significantly tempered, mitigated, or renegotiated at regional and local levels. this more nuanced interpretation of the interactions and tensions between global imperatives and local (or domestic) factors provides a useful backdrop for inquiry into the comparative developmental conditions between the atlantic and pacific cores, a task that has assumed greater importance both in the wake of the asia-pacific's dynamism over much of the past three decades, as well as the serious downturn that commenced in mid- in many east and southeast asian economies. this crisis, which delivered a major check to the continued growth and progress of many of the leading economies of the region, presents a complex set of economic, socio-cultural and political issues and underlying causes that vary widely from place to place, but certainly includes important structural factors (relating to governance, policy, regulation, and financial supervision), as well as more transitory or cyclical attributes (mcleod and garnaut, ). an apparent recovery process can be discerned in some of the asia-pacific economies, but the experience is likely to be protracted and wrenching for many, as the (now decade-long) recession in japan seems to attest. sustained recovery (and, more pointedly, a shift from growth to development) will require major adjustments to the political structures of asia-pacific states, as well as to the governance of corporations and industrial enterprises, and to the supervision and regulation of banks and financial institutions. both the depth and breadth of this economic downturn (and attendant social and political upheavals), and the quarter century or so of recurrent high growth levels that preceded it, raise questions concerning the contrasting trajectories of development within the mature atlantic economies and those of the new core of the pacific basin, as well as the factors underlying these patterns of differentiation. certainly one of the most salient and defining contrasts in the post-war trajectories of the atlantic and pacific spheres concerns the relative status and roles of the secondary (manufacturing) and tertiary (service) sectors, respectively, and the ensembles of policy, market and socio-demographic influences on these distinctive sectoral specializations. beyond the obvious reality that the leading states of both the pacific and atlantic spheres contain advanced industrial production sectors, and are experiencing growth in tertiary activity, it is important to acknowledge that while the growth of services represents a dominant motif of the economic and social reconstruction of western economies and societies, the accelerated growth of manufacturing industry and employment has been the principal story in the rise of the asia-pacific economies over the past four decades. among the mature economies of the oecd, concentrated within the old atlantic core, this same period has seen a massive contraction of production capacity and labour in basic industries, especially in fordist mass-production manufacturing, manifested most dramatically by wrenching processes of industrial decline (consisting mostly of outright factory closures but also some measure of locational decentralization) within long-established inner-city industrial precincts of large-and medium-size cities, and consequent losses of employment, income and revenue (noyelle and stanback, ) . new industries characterized by flexible specialization processes and technology-intensive outputs have emerged in 'lead regions' and 'new production spaces' (scott, ) within the atlantic core, so aggregate manufacturing output has held up or even increased (by value) in some areas (coffey, ) , but in general manufacturing activity has lost ground in relative terms in most oecd regions. over the past half-century, services have been essential features of the development of metropolitan cities (gottmann, ) . more specifically, intermediate services have emerged as increasingly strategic and propulsive elements of advanced production systems, as observed in successive rounds of industrial restructuring, in new divisions of labour, and in the rise of service-based global cities and new urban service poles (table ) . at the same time, the post-war period has seen among the most advanced societies the sustained expansion of service industries which (with related shifts in industrial production processes) have profoundly changed the economic base, industrial mix, labour force, land use and physical form of city-regions within the atlantic zone. service sector growth has thus constituted a central feature of economic restructuring among advanced nations and regions, with service-type occupations leading employment formation not only in the tertiary and quaternary (or informational) sectors, but also in manufacturing, where the growth of management, clerical, sales and technical workers has exceeded that for direct production workers and operatives in most cases. in general scholarly attention to the growth and development of service activities has evolved as follows: (a) an early interest in the growth of high-rise offices in the cbds of the largest metropolitan cities, including important theoretical and conceptual contributions (gottmann, ) , (b) a stream of empirical studies of office location, emphasizing regional policy implications and urban planning problems (daniels, ; goddard, ) , (c) growing interest in the social ramifications of services growth (bell, ) , (d) a sharper analytical focus on business, 'producer' and other intermediate services, and their role in urban and regional development (noyelle and stanback, ) , and in the operation of 'flexible' industrial regimes, (e) assessments of the global dimensions of services development, especially in banking and finance, as well as in producer services and communications (daniels, ), (f) acknowledgement of the importance of specialized services in the emergence of the 'informational city' and urban society (castells, ) , and (g) explorations of the intersections between tertiarization, occupational shifts, urban class (re)formation, and community-level impacts, especially in the metropolitan core (ley, ) . ( ) producer services as key to flexible specialization production regimes (coffey) ( ) emergence of integrated sevice-technology-production systems ( ) internalized service production ( ) externalized service production ( ) globalized service production ( ) but these structural consequences of tertiarization extend well beyond the economic dimension, as the sustained expansion of service labour (and concomitant decline in bluecollar workers) within the atlantic core regions has led in turn to the reformation of urban society, in terms of social class, community and neighbourhood patterns, culture, and political values and preferences, as documented in scholarly treatments of post-industrial society (summarized in table (a)). the tight spatial bonding of specialized, contactintensive service industries within intricate input -output relations has been instrumental in the reformation of urban structure and land use within the metropolitan core (gottmann, ; hutton and ley, ) . tertiarization has also generated more comprehensive changes in metropolitan structure, as seen principally in the emergence of specialized service nodes and clusters which dominate the space-economies of advanced city-regions, and also in urban form and the built environment, exemplified in the growth of the central city corporate complex, new districts of services production and consumption on the cbd fringe and inner city (including design and technology-based services), regional office and retail centres, and proto-urban forms which incorporate advanced service industries within 'edge cities' (garreau, ) (table (b)) . while tertiarization stands as the definitive and most consequential feature of economic growth and social change among western or atlantic nations and regions over the post-war period, industrialization has represented the principal development modality for much of the asia-pacific since the s and s. (although there have been to be sure important shifts in agriculture and other forms of primary and staple production in many pacific nations.) there is of course considerable variation in the temporal sequencing, specific industry emphasis, scale and stage of manufacturing growth among individual nations (and even among regions and sub-regions), but accelerated industrialization, supported in most cases by state policies and programmes, has been central to the expansion of every high growth asian-pacific state (douglass, ) , including ( ) the japanese ascendancy, seen in the industrial development of the japanese archipelago (especially within the principal conurbations of honshu but also including urban centres in kyushu and hokkaido) over much of the present century, with accelerated development of production in industrial and consumer goods from the s, including see garreau ( ) for an original contribution to our understanding of this spatial and socio-economic phenomenon. i am making a broad distinction here between economic systems in which manufacturing or (alternatively) services are dominant. it is of course possible to perceive services as 'industrial activities', as detailed divisions of 'service industries' are conventionally depicted within sectoral aggregations in standard industrial classification catalogues, for statistical purposes. moreover, there is a general preference for positioning service industries as co-dependent elements of integrated production systems (gershuny, ) . at the same time, industrialization as a development paradigm within the asia-pacific has certainly implied a powerful emphasis on the growth of manufacturing industries, industrial companies and conglomerates, factories and industrial labour, in the form of factory workers, assembly line employment, and operatives. jonathan rigg's analysis of modernization and development in southeast asia includes a special chapter addressing the idea (and reality) of 'the factory world' as a defining feature of this experience (rigg, : - ) . table defining attributes of advanced urban tertiarization defining conditions within highly tertiarized cities (a) urban industrial structure, economic base, employment and class sectoral/industrial structure tertiary sector larger than secondary sector; service industries growing faster than manufacturing industries both in relative and absolute terms industrial output services share of urban/regional gdp growing faster than manufacturing share market orientation/production linkages intermediate sector services growing faster than final demand services; specialized services and manufacturing co-dependent elements of advanced production systems urban economic base services comprise large and increasing share of urban economic base; significant and growing volume of specialized service exports and trade employment . % of urban employment in service industries occupational structure rapid growth of executives, managers, professionals; emerging social division of service labour favouring knowledge-and technology-based service workers, design, creative and cultural services urban class structure emerging hegemony of 'new middle class' (ley, ) of upper-tier service cohorts urban social morphology extensive social upgrading (gentrification) in older inner city neighbourhoods; growth of inner city loft housing and 'live-work'/'work-live' studios; increasing social displacement and inter-group tensions (b) urban spatial structure, space-economy, form, image and identity urban/metropolitan structure service industries dominant elements of urban core and (established or incipient) metropolitan sub-centres urban space-economy specialized service clusters and corridors dominant features of urban/ metropolitan space-economy (cbd corporate complex, seaports and airports, distribution centres, retail centres, higher education institutions, government and public administration, business parks, r&d parks] inner city landscapes new and emerging precincts of specialized services: applied design, creative and cultural services; internet providers and 'dot.com' firms; cultural centres; higher education; professional sports and entertainment; public recreation; live-work studios and new artist/artisan neighbourhoods urban form mix of modernist-post-modernist urban forms: high-rise office precincts in cbd and metro sub-centres, as well as new services domiciled in 'reconstructed' services production and consumption landscapes within inner city and inner suburbs; 'edge cities' and proto-urban forms on the metropolitan periphery infrastructure derived demand for transportation and other infrastructure associated with urban tertiarization identity post-industrialism; post-modernity image 'global' or 'world' city (hall, friedmann, sassen) ; 'informational city/society' (castells) ; 'transactional city' (gottmann) the expansion of global-scale industrial conglomerates and mncs; ( ) the origins of takeoff growth among the newly industrializing countries (nics), with accelerated industrialization initiated in taiwan and hong kong in the s, and singapore and south korea about a decade later (mcgee and lin, ) ; ( ) the later emergence of the 'threshold' or 'near' nics, notably malaysia and thailand, which retain important bases of agriculture and staple production outside the principal metropolitan zones, but which have experienced substantial manufacturing growth over the past two decades; ( ) the tumultuous growth and transformation of china, dating from the ideologically impelled industrialization programme enunciated in the series of -year economic plans commencing in the period - , to the industrial stimulus generated by the economic liberalization policies launched in , and then to the more recent expansion of advanced manufacturing in the lower yangtze, pearl river delta, and certain other coastal regions; ( ) the larger role played by industrial development in the transition of other populous agrarian nations, notably indonesia and the philippines; and ( ) the current economic restructuring programme in vietnam, associated with the 'doi moi' policy of economic and social renovation. in addition to these important examples, industrialization also represents a goal (or ideal) of lagging states within the region, such as laos, burma and north korea, although the realization of these industrial aspirations has been seriously impeded by a prejudicial mélange of factors including war, flawed development models, governmental corruption and administrative incompetence, lack of capital and other resources, and isolation. these national industrialization programmes and trajectories also featured important urban and regional dimensions. by the s, the asia-pacific sphere included a number of world-scale industrial metropoles, such as tokyo, nagoya, osaka, seoul, taipei, hong kong and shanghai, while by the s manufacturing emerged as an important feature of the metropolitan space-economies of southeast asian primate cities, including bangkok, jakarta, kuala lumpur, and manila (douglass, ) . beyond these large-scale urban industrial complexes, manufacturing activity increased within the metropolitan periphery, exurban areas, and even rural zones, for instance in the lower yangtze region, within the chinese special enterprise zones (sezs), within designated receptor areas (such as penang) for japanese foreign direct investment (fdi), and within desakota areas of east and southeast asia, proliferating the spatial milieux for industrial production in the region. even in pacific america, within which urban tertiarization processes are generally advanced, some city-regions have exhibited greater buoyancy in manufacturing than many of the older industrial cities of the great lakes region and eastern seaboard, within the broadly defined atlantic core. over the past two decades, los angeles, the san francisco bay area, seattle and even vancouver have experienced significant growth in advanced manufacturing such as aerospace and electronics (and in some basic production industries as well, such as garment production) within their regional territories, in contrast to the record of industrial decline in many other north american metropolitan areas, although to be sure they have also experienced high growth in service industries, and contractions in some traditional industries. at the end of the th century, then, industrialization represented the dominant trajectory for many states and regions within the asia-pacific, constituted a significant aspect of growth (together with specialized services) in some of the more advanced economies of the pacific realm, and remained an aspiration of lessdeveloped, agrarian and staple-dominated countries in the region. these industrialization trajectories will continue to be highly influential in the development of asia-pacific cityregions in the new century, but it is equally clear that service industries will emerge as increasingly significant features of urban growth and change, a theme we will explore in the following chapters. to date there has been relatively little scholarly attention paid to the development of service industries and employment within the asia-pacific, with the notable exception of case studies of cities within which services (especially advanced or 'higher-order' services) are playing significant roles (taylor and kwok, ) , and specialist studies of banking, finance and investment, and transportation and communications. the research emphasis has tended to be on multinational service corporations and international trade in services (waelbroeck et al., ; thrift, ; unctad, ; sieh-lee, ; lasserre and redding, ) , rather than on services development and associated issues for cities and city-regions. this situation reflects, to some extent, the pervasive influence of industrialization as a development paradigm within much of the pacific realm, emphasizing the primacy of manufacturing and industrial production within the growth trajectories of many asia-pacific states, regions and societies. the hegemony of the industrialization paradigm has created a kind of shadow effect within the scholarly literature on the economic development of the pacific basin, within which services are customarily treated as elements of the traditional urban retail or commercial sector, as essentially ancillary activities which can be effectively subsumed within industrialization processes and systems, or as special, almost aberrant features of exceptional cases such as hong kong and singapore. indeed, many of the region's leading service industries and corporations (notably banks, trading companies, and ocean freight lines) were established to facilitate manufacturing growth and the expansion of trade in goods, thus comprising essential features of the asia-pacific's industrialization experience. moreover, service industries, including modern, advanced services, are now sufficiently well-represented in a broad sampling of national and regional jurisdictions, and are now so increasingly central to the economic and social transformation of pacific cities, that a more incisive investigation of services growth trends and associated impacts is clearly merited (o'connor, ) . the centrepieces of urban service sectors within the asia-pacific are of course the large national and multinational service industry corporations, including the major banks and financial institutions (including brokerages and securities companies), trading houses, property firms, integrated construction and development corporations, and the leading airlines and hotel groups. these are, as is well known, highly concentrated within to illustrate, rigg's generally excellent and insightful treatment of 'modernization and development' in southeast asia offers only a single index reference to 'services' (and that one brief discussion in the text pertains to informal service activities), in the interest of focussing on the very important developments in agriculture and manufacturing, although modern service industries have certainly been instrumental to the growth of singapore, are of more than marginal significance to the development of malaysia and thailand, and are important features in the economic landscapes of the primate cities of southeast asian nations, including indonesia, the philippines and vietnam. the region's first-and second-tier global cities, especially tokyo, osaka, seoul, taipei, hong kong, singapore, los angeles, san francisco, and sydney. many of these financial corporations and other large service enterprises have become extensively globalized, enhancing the status of the cities within which they are domiciled; but a significant proportion of these corporations have been seriously damaged by the events of and after, and there have already been a number of major bankruptcies, with, no doubt, more to follow. the corporate power of cities within the asia-pacific is therefore pervasive, but by no means immutable. at a smaller scale, we can identify the full range of intermediate or producer services which, as in the mature economies of the atlantic sphere, typically include corporate legal firms and accountancies, management consulting firms, public relations and personnel companies, technical service operations, as well as planning and architectural firms which cater wholly or in part to the corporate sector. at the vanguard of growth and change there are also an expanding number of firms in the computer software and knowledge industry groups that are so crucial to the progress of advanced, information-based economies. in general, however, this intermediate services subsector (comprised mainly of small-and medium-size firms) is somewhat less well-developed in asia than is the case among the leading regional and national economies of europe and north america, where the producer services are seen as essential to the efficient operation of flexible production regimes, and have constituted the most dynamic elements of these economies and labour forces over the past two decades. this disparity is reflected in the large balance of trade deficits in specialized services incurred by most pacific asian nations (daniels and o'connor, ) . we can provisionally attribute the (relatively) less developed nature of intermediate services within the asia-pacific to a number of factors and conditions, including the perhaps obvious observation that services are generally at a less mature stage than among the more advanced atlantic core economies. however, there are also important structural factors as well. these include, notably, contrasts in the regulatory conditions and legal and contractual regimes between countries, which impose different kinds and levels of requirements upon firms domiciled within these jurisdictions. within many of the western societies these regulatory and legal regimes have become exceedingly complex and demanding, giving rise to specialized intermediate service firms which provide expert advice to corporations on a subcontracting basis, as the demand arises. within the asian realm, as we have already noted, many of these specialized service inputs are generated either internally within the corporation, as is the case with some of the larger korean and japanese conglomerates; or, as is the practice in many firms in china and southeast asia, are supplied by a network of advisors defined by kinship and social relations. moreover, there has been a substantial (if spatially and temporally uneven) growth of producer services within the asia-pacific, reflecting "the wide socio-cultural heterogeneity in this region and the distance between trade centres" (ho, : ) . at the leading edge of change among a growing number of asia-pacific societies, the implications of service industry growth may at least selectively reflect the experience of the mature economies of the atlantic-centred core, within which specialized service industries ( ) represent both agents and outcomes of economic restructuring, as well as leading elements of overall urban and regional transformation; ( ) constitute (with technology and manufacturing) co-dependent elements of advanced, flexible production systems; ( ) are associated with important, and in some cases defining, new divisions of labour and social class reformation; ( ) reflect, in part, increasing income levels and consumption rates within host societies; and ( ) have become significant elements of inter-regional and international trade flows, reflecting inter alia externalization tendencies and aspects of competitive advantage for specialized services production, export, and trade. as observed among the mature industrial (or post-industrial) societies of the atlantic sphere, too, service industries within the asia-pacific tend not to be distributed evenly across national territories, but are instead concentrated within urban regions, reflecting the spatial association between consumer services and their residentiary markets, and the even more centralized patterns of highly agglomerative intermediate (or producer) services. there is also a tendency toward greater levels of specialization in services production among larger cities, although there are to be sure some notable exceptions to this. this correlation between tertiarization levels, growth rates and degrees of specialization is of course most easily observed among the region's major corporate centres, such as tokyo, hong kong, and singapore, but the familiar spatial manifestations of service industry growth (cbds, corporate complexes, commercial strips and nodes, and the like) are features of a growing roster of asia-pacific cityregions, although their specific form may be locally distinctive. the study of specialized service industries within the asia-pacific, then, as in the atlantic sphere, necessarily implies an urban emphasis. these important commonalities notwithstanding, even at the most generalized level of analysis we can readily identify some defining distinctions between current services growth rates, development patterns and interdependencies within the new core of the asia-pacific, and those observed within the atlantic-centred old core. as in other facets of urban development, it is essential to achieve an appreciation of signifying contrasts in urbanization experiences in the asia-pacific, as distinct from the patterns of urban development within the atlantic core (lin, ) . these contrasts include the following: . generally higher growth rates of service industries and employment among asia-pacific nations and city-regions over the past decade and a half, reflecting more incipient stages of tertiarization in many asian jurisdictions and, broadly, more buoyant economic conditions over the past two decades or so. by way of contrast, service growth in europe has been (as daniels notes) slow or even stagnant (daniels, ) . (it must, however, be acknowledged that the depressed condition of certain asian currencies and financial markets are diminishing growth expectations in financial and service sectors among certain business centres over the short-to medium-term, and ensuing political instability and social unrest will almost inevitably exacerbate those impacts. moreover, urban service sector growth rates will inevitably slow among advanced cities with high existing levels of services labour, including singapore, hong kong, and japanese cities). asia-pacific city-regions, which represent in many cases significant departures from the more linear patterns of service industry growth common to the old atlantic-centred core. these contrasting tertiarization trends and processes are in part a consequence of the widely varying stages of overall development among specific national and regional jurisdictions, but are also associated with important (and in some cases decisive) policy factors and local development strategies. . the diversity of services-production linkage patterns among asia-pacific economies, which to some extent may follow the services externalization and subcontracting processes widely documented among european and north american firms, but are also exemplified in other respects by the distinctive nature of industrial organization in 'lead' asian economies in which large integrated corporations (keiretsu in japan, the chaebol in south korea) maintain internalized service supply; by the intricate entrepreneurial networks based on kinship relationships in parts of east and southeast asia (hsing, ) ; and by the intimate spatial linkages between industrial production and service providers observed in exurban or countryside production regimes in certain regions of china (marton, ) . . variation in the reconfiguration of metropolitan space-economies to accommodate the introduction of new, specialized service industry nodes and clusters, which follow to some extent the locational tendencies of services in advanced economies and city-regions; while at the same time exhibiting persistent spatial patterns derived from more traditional systems of urban and regional economic development, as exemplified in the desakota areas of southeast asia and japan, and, at a smaller scale, the intimate juxtaposition of advanced and informal service activities in central areas of developing societies (leaf, ) . in the most advanced cases, new spatial patterns of specialized services production include clusters of design, creative services, and advanced-technology service industries within reconstructed inner city precincts. . distinctive divisions of labour within urban service industries, which may appear to mimic the western model at the apex of the occupational hierarchy (i.e., the growth of managers, professionals, knowledge-based and advanced-technology workers), but also display substantial variation, derived in large part from localized culture, class structures and traditions, the pre-existing base of service workers, and region-based entrepreneurial or mercantile cultures. to these broad points of contrast in the tertiarization experiences of the asia-pacific and atlantic spheres, it is essential to highlight important differences in policy approaches and roles. within the asia-pacific, we observe a spectrum of (sometimes quite assertive and even grandiose) developmental policies and programmes designed wholly or in part to promote the growth of specialized service industries. these include the highly dirigiste approaches of japan (shapira et al., ) and singapore (ho, ) , within which central governments have assigned leading roles to advanced service industries in support of urban and national economic transformation, and enhanced roles for service industries in local economic development strategies and policies. in contrast, public policy approaches toward services among western societies have tended to emphasize regulation, including zoning, development control, and growth management, in addition to mostly episodic experiments with developmental policies, and only very exceptional attempts to undertake service industry 'megaprojects' on the heroic scale of numerous asian cities. although there are profound differences in stages and levels of tertiarization among asia-pacific city-regions, as we shall shortly see, the implications of urban service industry growth can be structured within five broad categories: ( ) a set of essentially propulsive and transformational impacts, within which services (especially advanced intermediate and knowledge-based service industries and institutions) are assigned leading roles in urban, regional and even national development; ( ) the (direct and indirect) impact of services on the internal restructuring and reconfiguration of the city-region, including regional structure, the metropolitan space-economy, and built form; ( ) services and the reformation of urban class and the city's social morphology (or ecology); ( ) implications of rapid tertiarization for the experiences of everyday life; and ( ) the role of services in the transformation of the city's image and identity. it must be emphasized that these are by no means neatly compartmentalized, discrete categories of consequence, however, as there are innumerable interactions and interdependencies between and among them. first, rapid tertiarization may have the potential to significantly accelerate the processes of urban growth and change, and to quite fundamentally modify basic urban economic functions or vocations, as reflected in the recomposition of the metropolitan industrial structure, economic base, and regional gdp. at one level, this process evokes the idea of post-industrialism, which positions service industries and occupations as ascendant features of the urban economy in a context of (relative or even absolute) contractions in basic manufacturing. however, in the asia-pacific setting the growth of specialized services can be seen as a concomitant element of advanced production systems, national modernization programmes, and globalization strategies of central and regional governments. these strategic aspirations are by no means fully realized, but they do underscore the importance of advanced services to the future development of the region. as is well known, tertiarization within many asia-pacific city-regions is impelled both by market and policy factors. this latter tendency is particularly marked in the region, as we can instance numerous examples of assertive public policy efforts both at central and local government and administrative levels designed to accelerate tertiarization (and/or deploy tertiarization as an instrument of broader economic and socio-economic transformation). examples of the deployment of policies for services in the interests of supporting or promoting transformational change include (a) synergies between national economic liberalization policies and local development strategies which have accelerated tertiarization processes (including advanced services) among designated chinese cityregions, (b) intersections between national industrial policies and urban economic programmes which have supported specialized service functions among japanese metropolitan cities, (c) ensembles of national development programmes and regulatory adjustments designed to enhance the growth of advanced, export-oriented services, as in the case of singapore since the mid- s, (d) central government support for strategic service industries as instruments of national development, accompanied by complementary local land use initiatives, as in the case of finance, producer services and information technology in malaysia, and (e) the more episodic (or less committed) support for service industries within (often somewhat schizophrenic) clusters of local development and growth management plans in sydney, melbourne, seattle, san francisco, vancouver, among other cities. the second category of urban tertiarization impacts concerns the role of services in change within the internal form and structure of the metropolis or city-region, and reflects the profound and comprehensive impacts of service industry development on the spaceeconomy of the contemporary city. the internal reordering of metropolitan space associated with rapid service industry growth incorporates processes which are multifaceted and interdependent: demand for services generates growth among service industries and firms to create a new sectoral mix within the city's economic base, and new patterns of services production and consumption as observed in the emergence of high-rise office complexes, secondary business centres, specialized service clusters (for example tertiary education and medical complexes), and new retail landscapes. these developments have visibly reconstructed urban structure and form in many american cities, but in some european cities have been situated more carefully within older districts, creating a more subtle and complex urban form, while in asia (for example in shanghai and osaka), preservation has been subordinated to the imperatives of accelerated restructuring, and has been in policy terms an afterthought at best. while market forces have constituted agents of urban respatialization, public authorities have deployed services as instruments of internal metropolitan reconfiguration within the asia-pacific, as in (a) the construction of new financial and corporate this urban 'policy schizophrenia' is associated, typically, with institutional conventions and operational practice within city and metropolitan governments. in most cases the urban 'plan' is prepared by staff planners, with input from other professionals and the broader community, and often emphasizes regulation, in terms of statutory development control functions and instruments (such as zoning, developing by-laws, and land use policies) and modern growth management modalities. by way of contrast, local economic development strategies are formulated by separate economic advisory groups, business interests, community groups and ngos, or special council committees or bodies appointed by (and accountable specifically to) the mayor or council chair, and are therefore often informed by quite different (and even oppositional) values and visions. a principal motivation behind the development of the la défence corporate complex was to protect the historic built environment of central paris from the kind of massive demolition and displacement impelled by office development in many other cities, by initiating a new 'cbd' outside the metropolitan core. this has been to a large extent realized (apart from exceptions such as the maine-montparnasse office-tower on the rive gauche), but the preservation of buildings and streetscapes in the central core of paris has been a series of struggles over the past century and a half (sutcliffe, ) . complexes, both to accelerate economic restructuring at the local level, and to support national modernization goals (as exemplified by the massive pudong project across the huangpu river from the established central district of shanghai) (yeh, ) , (b) the development of modern commercial and telecommunications infrastructure to support future world city aspirations (as seen in kuala lumpur), (c) the promotion of specialized financial and producer services in established cbds and designated subcentres to support world city status, and to maximize regional competitive advantage (with singapore presenting a vivid example), (d) the reclamation of land resources for accommodating the expansion of spatially or topographically constrained cbds (hong kong), and (e) the development of commercial and business megaprojects to diversify local economies, advance international business and financial relationships, and compete more effectively against other (often larger) centres within regional settings (as is the case with the minato mirai project in yokohama) (hutton, ) . more generically, public authorities also respond to infrastructure demand (for example airports and transit systems) derived from growth in services industries and activities (daniels, ) . the growth of service industries and occupations within asia-pacific city-regions also has important social implications, representing a third major set of urban tertiarization impacts. here, the growth of (especially advanced) service industries and related occupational cohorts generates an increasingly tertiarized labour force, which daniel bell described as a pre-condition for the emergence of a post-industrial society, over a quarter century ago (bell, ) : a contested idea, to be sure (gershuny, ) , but a seminal and prescient contribution in many ways. within the highly tertiarized city, the growth of specialized services leads to significant socio-spatial effects, including the familiar pattern of social upgrading within inner city neighbourhoods, and the formation of new suburban communities comprised largely of service workers, but also the recent emergence of a 'new middle class' of higher-echelon service labour (ley, ) . the rise of this new middle class of elite service workers (professionals, executives and managers, entrepreneurs and creative services occupations) as a presence in the inner city, a larger process than earlier, more incremental experiences of gentrification, comprises individuals who view the metropolitan core as a place to work, live, and recreate, leading to the transformation of the central city with respect to structure, land use, form, and lifestyles. there are also broader cultural connotations associated with the new middle class, as seen in shifts in tastes, values, behaviours, and even political affiliation. this new middle class enjoys a hegemonic status within the most highly tertiarized cities in the region, such as vancouver, seattle, san francisco, and sydney, and comprises the ascendant social cohort within singapore, tokyo, and hong kong, but is also observed as a growing presence (with some local variation in specific features) within the central districts of seoul, shanghai, guangzhou, and kuala lumpur, among other cities. the fourth set of impacts of service industry growth within cities of the asia-pacific concerns changes at the micro-level, what braudel termed the 'structures of everyday life' (braudel, ) . although much of the scholarly analysis of tertiarization has emphasized change within the three strategic categories described earlier, a more nuanced appreciation of the more intensely localized implications of growth in services is essential to attaining an appropriately rounded profile of the process. these include, for the purposes of illustration, the impact of service industries and the growth of service occupations on the quality of working life, and on localized displacement and dislocation at the neighbourhood and household levels (chua, (chua, , , especially within a context of industrial decline or restructuring. there is considerable potential for research on the important gender aspects of tertiarization, which may include the tendency for over-representation of females within many service occupations and industries. within the highly tertiarized societies of the old atlantic core, the past several decades have seen both the impressive progress of women within some of the credentialized service occupations, for example in law, accountancy, and planning, but also a more discouraging tendency for women to congregate in more menial, poorly paid and distinctly marginalized positions. there are also important linkages between the growth of service industries in asia-pacific cities and international migration. australian scholars have suggested that immigration can enhance the 'productive diversity' of economies, and more specifically that skilled immigrant professionals can support urban services exports, for example in sharing or transferring within the firm knowledge about overseas markets (aislabee et al., ) . lin observes that characteristics of mobility, flexibility and entrepreneurial skills are defining attributes of hong kong migrants (lin, : ) , enhancing their attractiveness to receiving urban societies and business communities. in certain cities, recent immigrants are over-represented both within entrepreneurial and management occupations, but also among more menial service occupations; this is especially the case in large global cities (sassen, ) . again, as in other facets of tertiarization, we can discern within asian labour markets some powerful resonances of trends initially observed in mature cities of the atlantic core, but there are also quite distinctive, persistent traditional socio-cultural contexts to consider. the importance of maintaining a perspective on the more localized implications of tertiarization also acknowledges the reality that the expansion of service industries by no means involves just the formal business, professional and managerial activities that have led growth among the western urban economies, but also the full range of neighbourhood shops and markets, casual restaurants and bars, and personal and retail services (to say nothing of other service establishments that may operate on, or even over, the margins of legality and social acceptance). in many asian cities, these smaller scale service operations may be viewed as an extension of the traditional population of informal service workers (itself a contested term), service activities which occupy the urban interstices between the more formal corporate business and retail structures. these can be seen as persistent features of the central city, not only among the megacities of southeast asia, such as bangkok and jakarta, but also within the downtown spaces of modern world cities such as tokyo. they are not simply residual activities, but essential, if often undervalued, operations that support the more formal service economy in different ways within the metropolitan core, including the provision of food and beverages (yasmeen, ) . these small-scale, low-return service firms survive by virtue of entrepreneurship, reliability, thrift, and knowledge of where the commercial niches exist in the modern city, and they contribute to the vitality and identity of the urban place. a final aspect of urban transformation associated with tertiarization is derived from an accumulation of the changes described earlier-economic, social, cultural, physical, and spatial-and is commonly articulated as a metamorphosis of the city's character, as perceived by citizens (constructed as 'identity') or as reconstructed by government and corporate entities and external agencies ('image'). the perceived image of a city can be substantially altered by comprehensive processes of tertiarization, as seen in the repositioning of singapore and hong kong as post-industrial, specialized service centres, although usage of decidedly obsolete nomenclature such as 'newly industrializing economies' is surprisingly persistent, as are outdated tropes like 'little dragons' or 'little tigers' (cartier, ) . in some cases national governments have supported specialized service industry projects as quite deliberate instruments of urban re-imaging, as seen in the creation of international banking and producer services in the pudong development in shanghai, and in the construction of the petronas towers in the central area of kuala lumpur. these initiatives are designed in part to underscore a commitment to modernity, and by extension to symbolize national economic progress and aspirations to global status and engagement, but also to supplant traditional (or, more pejoratively, 'backward') industries and related social groups. these more grandiose visions can be contested, especially where the elite beneficiaries of advanced service industry growth (for example professionals and managers in financial and business services, as well as cronies of rulers and oligarchs) represent a particularly visible and privileged expression of dichotomous 'development' as set against the condition of the urban masses in places like jakarta and manila. the issue of urban identity may also be deeply problematic, as the rapid growth of services elites within asian-pacific cities can presage decisive shifts in power relations (political as well as economic) within the urban community. in some cases the ascendancy of upper-tier service workers represents a new socio-economic and socio-political hegemony, implying a coincident subordination of traditional industrialsector cohorts, as well as an exacerbation of income disparities. as in other aspects of urban tertiarization within the asia-pacific, contrasts in scale and stages of development are significant, as are tendencies toward exceptionalism when case studies are subjected to closer analysis. thus, baum concluded that the sustained growth of specialized service industries, advanced-technology activities and related occupations in singapore, coupled with comprehensive public housing programmes and education investments, has resulted in a predominantly professionalized (as opposed to polarized) occupational and social structure within the city-state (baum, ) . in hong kong, where specialized services have also driven urban growth and socio-economic change (kwok, ) , the post-colonial record since includes growing poverty (about residents earn less than $ per month), attributable in some part to the inadequacies of the secondary school system, a situation which one legislator fears may lead to 'serious social instability' (lee cheuk-yan, quoted in far eastern economic review: october ). at a larger scale, a combination of market liberalization and selective tertiarization in certain chinese cities, with attendant political and bureaucratic corruption, has generated income polarization rates approaching or even exceeding the american level. this striving for new urban identities in the chinese case, with its repressed tensions and conflicts, can be seen in the shanghai government's preference for 'high class' individuals (well-educated, with the right attitudes, outlooks and professional profiles) for the glittering new towers of the pudong project (halliday, ) , a far cry indeed from the earlier communist exaltation of the urban industrial worker and fraternal colleagues in the pla and in rural peasant communes. we can also discern highly localized intersections of globalization and tertiarization in the reconstruction of identity at the district level. the proliferation of transnational retail and food services within commercial complexes is of course a ubiquitous phenomenon, as observed in places like shinkjuku and shibuya stations (and commercial subcentres) in tokyo. in hong kong, the incursion of service industry commuters in the new territories has transformed the social identity of certain of the post-war industrial communities, as seen in the transformation of tsuen wan from 'hakka enclave' to 'post-industrial city' (johnson, n.d.) . in the case of singapore, the last decade has seen the demise of the kampung kopi-tiam (informal eating places, serving authentic local fare) as a result of relentless modernization (chua, ) , and the almost total disappearance of traditional rural life, while other local retail and shopping districts have been subject to the reformation of identity associated with the tastes and behavioural preferences of affluent expatriate populations. chang deploys the term 'expatriatization' to describe a "spatial transformation in which land use increasingly reflects an expatriate bias", as typified in holland village, a local commercial centre within an affluent residential district of singapore, but one which "reflects the influence and influx of global cultures" (chang, : ) . in the most highly tertiarized cities within the asia-pacific, exemplified by san francisco, seattle, vancouver, sydney and singapore, a distinctive urban profile associated with dominant service industries and occupations within the financial and producer services now incorporates a more recent overlay of technology specialists, notably internet providers, software developers, and the so-called 'dot.com' firms. many of these firms have been concentrated within "new service production landscapes" within or proximate to the central area, exemplified by 'silicon alley' and telok ayer in singapore, yaletown in vancouver, belltown in seattle, and the northeast mission and south park districts of san francisco (hutton, ) . these technology-based service firms (which also include graphic designers, who exemplify the production synergies of technology and culture in applied design) typically exhibit employment structures dominated by young entrepreneurs and 'techies', with distinctive skills and lifestyles, underscoring both the new social divisions of labour in the urban service sector, and the highly volatile nature of urban identity in the post-modern, globalized metropolitan order. over the last years, the number of these technology-intensive firms within inner city production districts has contracted significantly, as part of the crash of the dot.coms. however, new survey research has disclosed the emergence of 'hybridized' firms combining creativity and technology toward the production of high-value goods and services, signifying a new phase of development within the metropolitan core of advanced societies (hutton, ) . these trends therefore demonstrate both the volatile nature of recent phases of service industry development, as evidenced by the accelerated processes of transition and succession, as well as the distinctive role of the inner city as site of innovation. stages of urban service industry development within the asia-pacific the preceding narrative described important distinctions in the broader tertiarization experiences as observed within the old atlantic core and the new core of the pacific realm. at the same time, there are also quite profound differences in stages or levels of service industry development among (and within) asia-pacific nations, just as there are important contrasts in levels and rates of industrialization. the construction of typologies of urban tertiarization among asia-pacific city-regions is hampered by data constraints and conceptual problems, and more recently by the shortterm impacts of the crisis of currencies and financial markets of and afterwards. although this crisis was seen to depress prospects for the asia-pacific generally, the impacts have been spatially quite uneven, and as the fiscal-economic malaise spread within the regions of the asia-pacific, and within social and political domains, it is by no means beyond the realm of possibility that the medium-to long-term outlook for certain urban centres has been seriously compromised. thus, to the overall perception of dynamism among the urban service sectors and industries of the pacific region, we must add considerable uncertainty. there is also a clear need at the outset to acknowledge the increasing complexity of overall urban development patterns, within which (we are arguing in this paper) service industries are increasingly playing larger roles. to illustrate, terry mcgee, in a retrospective paper on his concept of 'the southeast asian city' published in following years of extensive fieldwork, observed that "while urbanization levels will continue to rise there will be much differentiation between countries which will make the construction of any one model of the southeast asian city impossible" (mcgee, : ) . in this interpretation, models (or typologies) cannot reasonably function as templates of "supposedly universalizing tendencies" (mcgee, : ) , but rather should reflect the importance of specificity and exceptionalism in urban development experiences. it may at least, however, be possible to structure a basic and highly simplified typology of tertiarization stages among representative classes of asia-pacific city-regions, as a means of gaining insights into the range of urban tertiarization trajectories, the nature of specialization in services among city-regions, and the association between service development and urban hierarchy in the region. here, a typology of urban service centres within the region, while inevitably masking considerable nuance, may at least serve to depict some basic features of functional differentiation. while tertiarization stages and levels vary widely among asia-pacific city-regions, service industries are certainly performing significant roles in urban growth and development across a range of city types and urban scales. there is by no means a strict correlation between urban rank-order and level of service industry specialization within the asia-pacific region. to illustrate, there are medium-size cities with considerable global reach in terms of corporate power and important specializations in strategic service industries, such as finance and information technology (notably singapore and seattle), while a number of mega-urban regions (for example jakarta and manila; see mcgee and robinson ( ) ) contain limited advanced services capacity relative to their overall urban scale. therefore, a typology of cities engaged in specialized services production and trade should incorporate 'suites' of services specialization and developmental progression, as well as attributes of scale and hierarchy. accordingly, table positions asia-pacific cities and settlements within seven principal categories of specialized tertiary activities, distributed spatially within urban clusters, corridors, or 'outposts' within the western and eastern littorals of the pacific basin (depicted cartographically in fig. ) . at the peak of the pacific urban hierarchy we find tokyo and los angeles, the dominant corporate control centres within this extensive economic and trading zone. these massive city-regions contain to be sure huge concentrations of manufacturing, and, indeed, exhibit greater industrial strength than many of the first order global cities of the atlantic realm, such as london, paris, and new york. both tokyo and los angeles have important, global scale advanced-technology industrial sectors, situated within their metropolitan and immediately proximate territories, including orange county (in the case of los angeles) (scott, ) , and the new production spaces of the tokyo metropolitan region (tmr) (fujita and hill, ) . however, while both tokyo and los angeles retain an impressive base of modern manufacturing capacity, their most insistent claim to global city status rests on their downtown complexes of international banking and finance, and headquarters of mncs, supported by highly specialized producer services and superior international communications systems and transportation networks. los angeles and tokyo are also global centres of cultural production and dissemination, media concentration, and applied design and creative industries. they contain major universities of high international standing, including ucla and usc (los angeles), and tokyo university and waseda within the japanese capital. of these two pacific regional first-tier global cities, tokyo has conventionally been ranked as the leading centre, in view of its base of multinational head offices, and more particularly, its concentration of major banks, securities firms and trading companies, but this status may need to be reconsidered in light of the fall-out from the crisis (and, indeed, the failure to effectively address structural and institutional problems in the national banking and financial sector over the last decade). tokyo has considerable underlying industrial and overall economic power, but there is certainly the prospect of serious erosion in its financial sector over the mediumterm at least, which may jeopardize its position within the triumvirate of highest-order world centres (which also includes london and new york). fig. . asia-pacific urban service centres: hierarchy and specialization. doel and beaverstock ( ) observe that despite the claims and assumptions of fully globalized capital markets, the asian financial crisis has had relatively little negative impact on london and new york banks and financial corporations. indeed, many of the european and north american investment banks, for example, have (at least quietly) rejoiced in the misfortunes of the japanese banks in particular, as the asian financial crisis has (at least for the moment) 'seen off' their japanese competitors. category within our provisional typology includes six second-tier global cities: hong kong, singapore, seoul, osaka, san francisco, and sydney. despite significant contrasts in urban scale (to illustrate, there is seoul with a population of over million; and singapore at million), each represents a major asia-pacific financial, corporate and business centre. they are all characterized by ( ) very large cbd corporate complexes of head offices, multinationals, international banking and financial activity and producer services; ( ) strategic gateway functions and major international airports; ( ) major universities and knowledge-based institutions; ( ) large concentrations of executives, professionals, managers, entrepreneurs and other higher-order service occupations within the metropolitan labour force, and ( ) a powerful international corporate 'reach', competing in some sectors or areas with other second-(and even some first-) tier global cities. in each of these six asia-pacific financial and business centres, we also observe new precincts of specialized services within the inner city, including design and creative services, multimedia and post-production firms, internet providers and dot.com firms, reflecting the 'advanced tertiarization' stage of urban spatial development depicted in table this typology serves to highlight very broad variations in tertiarization levels among selected city-regions within apec, but even a cursory examination of individual cases discloses considerable variation in the trajectory of restructuring and service industry development within each category. for example, both singapore and hong kong specialize in advanced service industries, including finance and banking, producer and other high order services, tourism and convention activities, and higher education. each is now a major exporter of services; hong kong is ranked as the th leading exporter of services globally (hang seng bank, ) . manufacturing has declined from . % of hong kong's employment in , to only . % in , a level comparable to that of the most highly tertiarized atlantic core societies (asian development bank, ) . upper-tier service industry professionals, managers and entrepreneurs constitute the dominant social class in hong kong (kwok, ) . however, hong kong's emergence as a centre of specialized service production and trade has been impelled principally by an exceedingly liberal regulatory regime, while singapore's restructuring trajectory has been enhanced by a more direct application of policy measures. following a brief but sharp recession in , the singapore government resolved to transform the city-state from a branch-plant industrial enclave to a regional (and world) centre of tertiary production and trade, with the aim of becoming the 'switzerland of asia' by . this overarching economic development and transformation goal has been to a large extent realized, and singapore now represents a policy experience that other nations (notably china) are endeavouring to emulate. although hong kong's classically laissez-faire approach contrasts sharply with singapore's explicitly dirigiste development strategy, selective public policy initiatives have facilitated hong kong's economic restructuring. as observed by taylor and kwok ( ) , hong kong experienced an accelerated transformation process over three decades, from an 'industrial metropolis' (export manufacturing phase) in the s, to a 'postindustrial' status (information service phase) over the s, and emerging as an 'international metropolis' by the s. a sequence of policy and (especially) physical planning measures were deployed to promote economic transition and transformation, including the industrial new town programme of the s, the expansion of the hong kong cbd eastward toward wanchai and causeway bay in the s, and the recent investments in transportation infrastructure, as in the linking of hong kong with guangzhou by expressway, and the construction of the international airport at chek lap kok. there have also been substantial new public investments in tertiary education, training and housing, underscoring a substantial government commitment to upgrading the quality of hong kong's human resources and social capital. these investments and land use policy initiatives suggest that contrasts between singapore's and hong kong's approaches to economic transformation which insist on sharply dichotomous contrasts may be somewhat overstated, although the extent (and sustained commitment) of direct policy intervention in the singapore case is in many respects singular. our third category includes second-and third-tier global cities, which feature large and generally fast-growing service sectors, established on a base of world-scale manufacturing and industrial production capacity in each case. we can identify two sub-categories (table ) within this aggregation: first, three 'advanced' business and industrial centres (nagoya, kobe and taipei) situated within leading east asian economies; and secondly, a set of 'transitional' urban centres which still possess some features of early phase industrialization and a relatively large informal sector, including 'floating' or transient labour contingents (beijing, shanghai, guangzhou, bangkok, and kuala lumpur). however, each of these large cities exhibits relatively high growth in producer services, including engineering and business services. other defining attributes of these centres are ( ) important international gateway roles, ( ) major public and private sector investments in higher-order services infrastructure, and ( ) ambitious local/metropolitan strategies for new, specialized service industry roles and 'vocations', supported in most cases by national government policies and projects. the japanese experience of tertiarization provides particularly instructive case studies, in light of the priority accorded industrial development up to the s, the lead role of the central government and its constituent ministries over the last decade in assigning new development roles incorporating specialized service and technology-based industries for the major cities, and the outcomes of these initiatives among different japanese cities (edgington, ) . in general, the central government has been concerned both with the need to maintain a leading edge position in industrial production within the asia-pacific, while preparing the large cities for more advanced roles in specialized services industries, both for the domestic economy, and for trade purposes. much of the research on economic restructuring in japan has emphasized 'hard services,' notably technology, and its role in transforming both industrial production modes and urban economic structures (glasmeier, ) , while another major body of scholarship deals with the transformation of tokyo, while hong kong has initiated over the past years numerous specific projects and programmes to support the expansion of service industries, singapore has enunciated policies and programmes to promote strategic services (e.g. banking and finance, producer services, and it) within more formal policy statements and structures, consistent with the city-state's distinctive policy culture and administrative styles. the recent expansion of design and technology-based services in heritage districts outside the cbd represented one of the few 'spontaneous' (or unplanned) economic phenomena in the city-state's recent history (interview with urban redevelopment authority official, july ), although there is now policy support for cultural industries administered by the tourism development board. japan's first-order 'world city' (masai, ) . important themes concerned with tokyo's transformation include tensions and conflicts between the capital's international roles and local functions (fujita, ) , and the problems of accommodating (or, prospectively, relocating) central government functions from tokyo's metropolitan core (isomura, ) . however, there has also been some important work focusing on the restructuring (and, more specifically, tertiarization) of other principal japanese city-regions. these experiences include the economic restructuring of tokyo (machimura, ) , the expansion of advanced services such as finance, information services, and education in the major industrial city of nagoya over the last two decades (hayashi, ) , and the new emphasis on advanced knowledge-based service industries for the transition of yokohama from gateway port (and 'shadow city' for tokyo), to a more independent role as international business centre (edgington, ) . the experience of metropolitan transformation among the largest chinese city-regions over the past several decades represents a striking example of the influence of policy priorities within a command economy, and the potential for accelerated tertiarization following an adjustment of central government policy direction. following the industrialization policies and programmes of the period over the s, s, and s (including the ruinous 'great leap forward'), chinese cities "were endowed with a massive and diffuse manufacturing capacity, and provided with few incentives (until the last decade) to develop the services sector" (hamer, : ) . the economic policy reforms of (and more specifically) the mid- s embodied a recognition that modernization would require the more efficient deployment of cities and their resources, and thus heavy manufacturing was increasingly decentralized to outlying areas, and services (especially financial and producer services) were encouraged, both by economic planners in beijing, and by local authorities. in order to achieve growth in advanced production and transition to a more knowledge-based economy, hamer estimates that "up to % of the local labour force will have to be employed in the producer services sector" (hamer, : ) , a proportion that seems high even by the standard of more advanced oecd cities, but is perhaps nonetheless indicative of municipal aspirations. lin also underscores the crucial role of cities in the modernization of the chinese economy as represented by their concentrations of advanced service industries and occupations which enable higher levels of creativity, efficiency, and internationalization (lin, : - ) . recent trends in beijing, shanghai, and guangzhou serve both to generally underline the growing importance of service industries within the development trajectories of major chinese cities, while at the same time demonstrating the exceptionalism of specific cases. in beijing, an acknowledgement of the inappropriateness of the soviet-style heavy industrialization of the ancient capital, with its attendant environmental and displacement impacts, sets the stage for a new development strategy reasserting political, administrative and cultural roles. the goal of the - master plan (approved october ) is to develop the "historic city into a modern, economically prosperous and socially secure international metropolis of first class world standard in services, infrastructure and environmental quality" (mao and jin, : ) , representing an abrupt departure from the industrial city model of the s and s. as the contemporary beijing master plan invokes the re-establishment of the capital's traditional administrative and cultural roles, shanghai's current transformation recalls financial and trading functions de-emphasized following the ascendancy of the communists to power. immediately prior to the ascension of the chinese communist party in , shanghai's financial sector included foreign banks, private and government banks, trust companies, and currency exchangers: "with such a large number of financial institutions, representing a high degree of concentration of capital, shanghai was in a position to control the economy of the entire nation" (fung et al., : ) . a succession of five-year plans emphasized the primacy of manufacturing for shanghai's industrial transformation, with a particular emphasis on heavy industry and the production of capital goods. by the completion of the first five-year plan (in ), shanghai had experienced a transition from an outward-looking financial centre to the leading industrial centre of an almost autarkic chinese state. the economic policy reforms of the late s and mid- s presaged the onset of yet another fundamental change in economic priorities for shanghai, and, more specifically, for the reconstitution of shanghai's financial, trading and business service functions. to a considerable extent, this massive effort in economic restructuring is intended to offer china a strategic access to the global economy (yeh, ) , but (at least at a subtextual level) the question of achieving a competitive position vis-à-vis hong kong in financial and trade services must be acknowledged. in this respect, shanghai has certainly attracted an impressive quantity of investment in banking and commercial (and supporting public) infrastructure, as well as a growing number of mncs and mnes, but has not yet achieved the high concentrations of domestic and expatiate professional expertise in specialized services that is a defining hallmark of highest-order global cities. (indeed, as kris olds has observed, shanghai's globalization strategy has been highly dependent on the engagement of the 'global intelligence corps' of elite professionals; olds, ) . here, hong kong is likely to hold a competitive advantage over other chinese cities over the short to mediumterm by virtue of the territorialization (storper, ) of this expertise and specialized human capital. the two fundamental shifts in shanghai's development trajectory over the past several decades can be interpreted empirically. in , the 'tertiary sector' (i.e. commerce, finance, communications, science and technology, education and culture) constituted . % of shanghai's regional gdp. following years of investment in manufacturing capacity and employment, this proportion was reduced to only . % by . the intensive promotion of advanced service industries during the s resulted in an increase in the tertiary sector's share of gdp to % by , while shanghai's economic development strategy called for an increase in this proportion to about % by (fung et al., ) , led by the advanced services complex in the pudong redevelopment mega-project. (shanghai's service sector grew by % in , and by % in ; chreod ltd, ) overall, shanghai's experience of accelerated industrialization and subsequent re-tertiarization must represent one of the most dramatic episodes of economic restructuring among large metropolitan cities in the post-war period. guangzhou is, of course, smaller than beijing or shanghai, but it performs strategic gateway roles for guangdong province and southern china as a whole, and has undergone significant processes of restructuring and tertiarization (xu and yan, ) . as in other large chinese cities, economic policy priorities following entailed the transformation of guangzhou from a 'consumer city' to a 'producer city'. this strategy of large-scale industrialization was perhaps less fully realized than in the case of shanghai, because of the persistence of entrepreneurial traditions in the province, and guangzhou's distance from the national capital, which enabled at least a degree of autonomy. building on its well-established gateway and entrepôt functions, guangzhou was strategically positioned to immediately benefit from the opening up of chinese coastal cities. in the period - , growth in services exceeded that for agriculture or manufacturing, with lead tertiary sector industry groups including finance and corporate support services (nanjiang, ) . guangzhou is the urban centre for the pearl river delta economic region, which represents (with the lower yangtze region and southern fujian) major growth regions and access points for china to the broader asia-pacific and global markets (johnson, ) . the issue of whether guangzhou can extend its regional role more fully into the national realm remains an open question (tsang, ) , as are the 'terms of co-existence' with hong kong following the latter's post-colonial status as a special administrative region of the prc as of july . there is to be sure potential for complementarity as well as competition as characteristics of the relationship between guangzhou and hong kong within the pearl delta extended urban cluster, a theme to be addressed in more detail below, but over time guangzhou will aspire to greater shares of the region's international financial and business activity. the fourth aggregation of city-regions depicted in table comprises metropolitan areas characterized by the advanced tertiarization of the urban economy and labour force. this fourth category of asia-pacific cities includes two sub-groups: first, advanced, highly tertiarized cities with substantial manufacturing capacity and associated labour cohorts, and propulsive corporations, notably seattle, melbourne, and yokohama; and a larger contingent of specialized services cities with relatively modest industrial production sectors, including vancouver, portland, fukuoka, and brisbane. in many respect these jurisdictions embody features of service industry development observed within the mature urban and regional economies of the old atlantic core, which typically include (a) a dominant status for services within the metropolitan industrial mix, export base, and occupational structure; (b) the formation of corporate complexes within the cbd; (c) the emergence of new, creative services (culture, applied design, multimedia) on the cbd fringe and inner city; (d) the influence of suburban business centres and 'edge cities' in regional multinucleation; (e) intersections between services growth and changes in urban housing markets; and (f) the increasing role of services in the reformation of urban identity, politics, and lifestyles (ley and hutton, ) . at the same time, many of the city-regions within pacific america and australasia also exhibit tendencies common to other asia-pacific metropolitan areas, such as (relative) economic dynamism and higher growth rates in services, and are also linked to asia-pacific cities, markets and societies by increasingly diverse networks of trade, investment, immigration and travel. as a crucial intersection of two principal processes of urban development, large-scale immigration, especially from asian societies, has in important respects augmented urban tertiarization processes, reinforcing entrepreneurial, professional and management occupations, and contributing to export services trade by enhancing the connectivity between trading centres. we can therefore position these cities as geographically peripheral, but functionally integral, nodes of the asia-pacific urban system and as important examples of a distinctive stage of urban tertiarization within the pacific realm. the fifth category within our provisional typology of asia-pacific cities engaged in services production includes several southeast asian 'mega-urban' regions, jakarta, manila, and (more tentatively) ho chi minh city. the emergence of relatively small service sector occupational elites within mega-urban city-regions such as jakarta, and manila must be set against a vastly larger informal sector of hawkers, vendors, and peddlers, which mcgee described as the urban 'proto-proleteriat' (mcgee, ) . even in second-tier cities, such as bandung, economic restructuring incorporating both industrial development and tertiarization has promoted a deeply polarized social structure (pribadi and sofha, ) . the imposition of advanced, high order services within the central and inner-city areas of southeast asian mega-cities has produced a distinctive juxtaposition of socio-economic classes, typified in part by the persistence of shanty towns, squatter settlements and informal sector activities proximate to high-rise office towers, high-end shops and boutiques, and other accoutrements of the later th-century corporate complex (leaf, ) . as leaf observes, the explanation for this notionally incongruous pattern of traditional social morphology and modern capitalist development features "lies in the segmentation of urban land markets…which is now most commonly expressed in terms of formal and informal sectors…derived from early patterns of land use not governed by market principles" (leaf, : ) . in the case of jakarta, in which about three quarters of the population live in informal settlements (kampung), social class differentiation is expressed "not so much by zone or neighbourhood, such as what one would expect in the capitalist city, but at a more minute scale, between streetside and inner block locations within the same neighbourhood" (leaf, : ) underscoring the complex (and often deeply problematic) impact of economic restructuring on urban social structure within developing societies. the continuing economic crisis within southeast asian economies has no doubt impacted the poor disproportionately, but has also damaged the small service elite of professionals, financial and business services workers within the region's primate cities. in addition to the direct effects of this crisis on the employment and incomes of the service elite themselves, it seems likely that wider ramifications may include the diminution of the advanced services production capacity of these developing economies, as well as an erosion of the (already small) middle and upper-middle classes within their respective societies. ho chi minh city (formerly saigon) also exhibits a highly dualistic socio-economic structure, but differs from manila and jakarta in some important respects. more particularly, the introduction of the 'doi moi' (renovation) economic policy has forcefully inserted a before the 'crash' of there was a generally growing constituency favouring economic, social, cultural and even political association among the nations of the pacific basin, derived in part from a shared vision of mutual economic interests and visions of progress, as well as a preference among some observers to view the 'modernist project' in pacific asia through the western critical tradition (preston, ) . in the short term at least the fiscal and economic crisis of the past years in asia has diminished the enthusiasm of some in the americas and australasia to be associated with the wider concept of the 'asia-pacific'. there are also signs of a more 'inward' (i.e. intra-asian, as opposed to transpacific) sensibility on the part of (for example) japanese corporations and the chinese, japanese and malaysian governments, although the motivations for these attitudinal changes vary. former japanese vice-minister of finance eisuke sakakibara, for example, suggests that the membership of the us within apec precludes the latter from being a 'true regional organization,' while vice-minister ito observes that "[t]he task for asian countries is to ensure that regionalism in asian really complement global trading and financial systems, like other regional arrangements in north america and europe" (quoted in t. armstrong, 'asia is going it alone', the globe and mail, monday february : all). market presence within an established socialist political and social order, with polarizing outcomes for ho chi minh city's labour force and society. advanced services are emerging as defining elements of the new ho chi minh city as depicted in an approved mural extolling " years saigon and ho chi minh city: industrialization and modernization", the modernist imagery underscored by a dominant motif of point towers (drummond, ) . in this regard ho chi minh city is something of a 'frontier city', characterized by significant autonomy from hanoi, a situation somewhat analogous to that of guangzhou in southern china, which operates as a bastion of market enterprise in contrast to the more formal cultural and political style of beijing. at the same time, hanoi too is endeavouring to expand its engagement with the global economy in its development strategy, while maintaining a measure of local policy protection for long-established informal services, implying a bipartite planning approach to service industries (leaf, ) . the final two categories depicted in the typology of asia-pacific urban service centres comprise more narrowly specialized cities and settlements. category includes important port cities with (in most cases) substantial industrial sectors, and some service industries ancillary to port functions, but otherwise relatively underdeveloped advanced tertiary sectors. this set of port/industrial cities includes, to illustrate, pusan, kaohsiung, kitakyushu, oakland, and tacoma. a number of these cities are aggressively pursuing industrial diversification strategies in order to escape dependence on older (in some cases distinctly obsolescent) manufacturing activity; these include kitakyushu, pusan, and kaohsiung. each of these cities is actively promoting new service industries which are seen as more progressive development modes or vocations for the st century, and at least two, pusan and kitakyushu, are joint signatories to official co-operation agreements. the seventh category includes generally smaller cities and settlements specializing in travel and tourism. these include tropical centres, such as denpasar and kona, as well as the major skiing and winter sports centres of sapporo and whistler, the latter now the largest ski resort in north america. these centres may also be candidates for major international events: sapporo has hosted a winter olympics, while whistler is an integral part of vancouver's bid for the winter olympic games. as we have seen advanced services exhibit strongly polarized spatial patterns within the asia-pacific, reflecting the power of urban and agglomeration economies, and the locational centrality of higher-order services in metropolitan areas. at the same time, we can envisage the emergence of spatially extended territories of specialized services production and exchange at the broader regional level, configured as multi-centred urban corridors. these corridors (or clusters) comprise in most cases regions with a dominant first-or second-order global city and a chain of interdependent, and generally smaller, but nonetheless important urban centres. the conceptual bases for the emergence of these there is of course some ambiguity in this terminology, but in general corridors encompass essentially linear arrangements of cities, as exemplified in the pacific north west corridor (vancouver -seattle-portland), while clusters can describe patterns of functionally linked (but dispersed or non-linear in form) cities within extended regional settings (for example the california bay area, which includes san jose, the silicon valley, oakland and berkeley, as well as san francisco). specialized functional territories can be traced to gottmann's seminal idea of megalopolis (gottmann, ), whebell's theory of corridors as urban spatial systems (whebell, ) , and mcgee's notion of extended metropolitan regions (mcgee, ) . they perform strategic service functions (including finance, corporate control, administration, information and communications, cultural and gateway roles), are linked both to regional production systems and to global networks of services trade, and exhibit aspects of complementarity as well as competition. fig. shows the location of major urban service corridors or clusters within the asia-pacific sphere: five in east asia (central japan -honshu corridor, the lower yangtze corridor, the pearl river delta cluster, and the taiwanese and korean corridors); one in southeast asia (the southern malay peninsula corridor); one in australasia (the southeast australian corridor); and three on the pacific coast of north america (the southern california corridor, the california -bay area cluster, and the pacific north west corridor). reflecting the corporate power of the asia-pacific's firstorder global cities, the two most important extended urban services territories are the central japan -honshu corridor, which includes tokyo, yokohama, osaka, nagoya, and kyoto; and the southern california corridor, incorporating los angeles, anaheim, orange county, and san diego. these first-tier metropolitan services corridors contain truly global-scale concentrations of most of the specialized service industry suites listed in table , including banking and finance, corporate control, producer services, gateway functions, advanced-technology and creative services, education and culture. however, there are certainly global-or international-scale service industry concentrations situated within other principal service corridors and clusters, as exhibited in table . these include, to illustrate, the california bay area (global-scale advanced-technology and creative services, higher education, tourism), the korean corridor (banking and finance, corporate control, gateway roles), the pearl delta (banking and finance, corporate control, gateway roles), and the southern malay peninsula (banking and finance, gateway roles, advanced-technology services, education). within the more compact urban service clusters, the expansion of specialized services territories acknowledges the need to accommodate back-office functions and local services in smaller regional centres, and to situate new airports and port facilities, university sites, and research and development facilities in peripheral or exurban areas outside the dominant metropolis, with the pearl delta cluster as an example. culture, amenity and lifestyle may constitute supporting elements of intra-regional services development in some cases, notably in the transboundary pacific north west corridor. advanced services have been crucial to the post-staples development of the pacific north west; at the same time, the amenity provided by wilderness areas is widely seen as a positive inducement to the specialized services and advanced-technology industries which increasingly define the economic base of this region, and is also embedded in social values and lifestyles. within certain of the larger territories, notably the central japan -honshu corridor, the recent development of metropolitan service centres reflects the changing division of production labour at regional and even national levels, presenting possibilities of reciprocal specialization in services within hierarchical and otherwise competitive urban systems. at the same time, there are to be sure examples of the 'uneasy co-existence' of national primate and second-and third-order cities within extended clusters, derived from hegemonic inter-city relations; the examples of seoul and pusan, and tokyo and osaka, come to mind. the dynamics of regional competition and complementarity can further be illustrated by reference to the pacific north west corridor, which includes the three major ports of vancouver, seattle, and tacoma. there is to be sure considerable competition among the three ports (which is likely to increase as major shipping lines continue to rationalize their trans-pacific rotations), but we can also observe aspects of specialization and complementarity: seattle and tacoma are major container ports, while vancouver specializes in bulk commodity exports and cruise ship travel (the port of seattle has recently increased its efforts to attract cruise ship traffic, with at least a measure of success.). at a broader level, the reciprocal strengths of services specialization observed in seattle, vancouver and portland enable the north west corridor to compete in some trade sectors with the san francisco bay area cluster (for example in international gateway functions), about km to the south. in each case the emergence of these multi-nucleated, interdependent services production corridors may presage the reorganization of regional economic space to enable economies of scale, scope, and specialization, in response to the pressures (and opportunities) of globalization. within certain of these corridors, for example the yangtze delta cluster, and the southern malay peninsula corridor (incorporating singapore and the kuala lumpur -putrajaya -cyberjaya technology corridor) this developmental aspiration is a matter of quite explicit political strategy (see for example the discussion in corey, ( ) ). in the japanese case, the central government has attempted to promote complementary clusters or corridors of advanced-technology industries and services within three hierarchical levels, in order to maximize efficiency gains, and minimize damaging inter-regional competition (edgington, ) . there is a perceived need to transcend the everyday rivalries of regional competition, in order to promote powerful international-scale banking and finance, corporate control, education and culture services, production and trade platforms, along the lines of mature counterparts within the old 'atlantic core', such as the us northeastern 'megalopolis' corridor, the paris-ile de france region, and the london-oxford -cambridge triangle. a demonstration of the mutual benefits of inter-city complementarity and co-operation in this sphere may in turn facilitate broader efforts at inter-regional and international colloboration, as encouraged by douglass ( ), among others. at the moment, cities within the region tend to see themselves as entities within essentially competitive international urban systems, with an obligation to devote more policy attention and public resources to fostering competitive advantage, at the expense of planning efforts designed to enhance local welfare (thornley, ) . over the last decade or so urban policy approaches to service industry development have evolved significantly, reflecting in part a more informed appreciation of the centrality of advanced services to urban development. however, in other respects shifts in planning approach in this policy domain incorporate responses to the challenges and opportunities of globalization, and innovation in planning styles, as well as efforts to reconcile regulatory and distributive issues with important developmental aspirations. as in the fundamental processes of urban tertiarization described in preceding chapters, we observe a number of important contrasts in urban service industry policies between societies of the pacific and atlantic 'cores', notably a much stronger emphasis on growth and development aspirations among the former, as well as some commonalities. accordingly, this chapter will entail a discussion of defining shifts in urban policy approaches to service industries, leading to a presentation of six leading models of service industry models, together with illustrative reference cases, in the following chapter. we can identify several principal phases of local planning and policy responses to the growth of the urban service sector over the past quarter century. broadly, the initial period emphasized development control policies, to manage negative externalities associated with growth in speculative office development; the second phase included developmental programmes, acknowledging the increasing significance of service industries to local economies and labour markets; and the third period has seen more assertive policies which deploy advanced services as instruments of industrial restructuring, modernization, and globalization, as well as increasing policy innovation and experimentation. first, the rapid growth of offices within central city areas over the s and s gave rise to a suite of regulatory local planning policies toward the urban service sector (daniels, ) . planning concerns during this period included the implications of rapid office development for the over-specialization of the urban economy, for the displacement of non-office industries and housing, and for long-distance commuting within the regional commuter shed. indeed, the journey-to-work problem, shaped by the expansion of the cbd's office complex, and the simultaneous decentralization of the urban residential population and labour force, was broadly seen as a defining metropolitan planning issue in many city-regions (davis and hutton, ) . the planning response to high levels of central city office development over the s and s included both increasingly stringent development control policies for the core (including downzoning, the imposition of annualized development quotas or thresholds, and fiscal measures), as well as efforts to promote new office subcentres within suburban areas. local planning responses to office activity and other service industries in this critical policy phase at times took on a strongly ideological tone. in britain and in other parts of western europe, left-leaning councils actively discouraged service industries, which were seen as displacing traditional manufacturing industries. this essentially prejudicial local attitude toward service industries was in part conditioned by research which subordinated the tertiary sector to secondary manufacturing within the urban or regional economy, based on measures of export performance, productivity, and sales and employment multipliers. however, to some extent stringent local planning controls on (especially office-based) services were strongly influenced by political opposition to the speculative property market, which was seen to favour office development over industry and housing, reflecting higher returns on investment (roi) for office development relative to other land use categories. examples of this ideologically derived planning response to urban tertiarization included the greater london council and most inner city boroughs during the s and early s. urban authorities continued to experiment with development control options for service industries, but by the mid- s a more positive (or balanced) local policy approach was in evidence among a growing number of local authorities. this more favourable local policy posture toward office activity and other service industries was influenced both by the implications of industrial decline in many large-and medium-sized cities, impelled by the collapse of traditional fordist industry, as well as by new research which underscored the key roles played by specialized services in advanced (daniels, ) . more particularly, the specialized intermediate (or 'producer') services were identified as crucial to the operation of 'flexible' production systems, to high-wage urban labour formation, to industrial productivity, to the urban export base, and to local revenues. in this new situation, urban governments and planning authorities began to introduce policies for (at least selectively) encouraging important service industries, notably banking and finance, transportation, business services, higher education, and tourism (coffey, ) . examples of more positive local planning and policy instruments for the urban service sector are depicted in table , together with corresponding instances of development control and other regulatory measures, across a spectrum of local policy fields. table contrasts planning approaches toward service industries according to preferences for 'developmental' or 'growth management' policy objectives, although in practice many local authorities tended to implement a blended suite of promotional programmes and regulation . however, important examples of quite dramatic policy shifts can be referenced, notably within cities of the broadly defined asia-pacific region. in the well-known case of singapore, a short, sharp economic downturn in the mid- s led almost immediately to aggressive new policies favouring specialized, high-value, exportable services, in part reflecting concerns about the prospects for singapore's manufacturing industry and regional entrepôt roles. in hong kong, the colonial government assertively supported the expansion of office activity and other key intermediate services, exemplified by the territorial expansion of the cbd, by public investments in education, and by increased international marketing (taylor and kwok, ) . and in vancouver, a centre-left city council approved an economic development strategy which set out a series of policies and programmes to foster important service sectors and industries, together with co-operative measures to be undertaken among key institutions, labour cohorts, and business groups (city of vancouver, ) . at the same time, the city of vancouver continued to co-operate with the regional planning authority, the greater vancouver regional district, in managing externalities of rapid growth in services, for example by supporting office development in designated regional town centres (rtcs), exemplifying the tendency to 'blend' both regulatory and developmental programmes within local policy suites. the experimentation with development programmes for urban service industries over the s and s marked a significant departure from the strongly regulatory promotion of a better spatial balance between employment generation and housing growth a principal policy goal information services support for active marketing of tertiary services in domestic and international markets promote or market secondary centers in the suburbs (e.g. by publicizing cbd/ suburban rent differentials) government liaison/ 'partnerships' lobbying of central/middle tier governments to promote tertiary industry development; including for changes in government policy/regulatory environments (e.g. in the sphere of finance and banking, air bilaterals) support for government decentralization policies involving public and private sector tertiary employment source: after hutton ( ). experiences of the previous two decades. however, major changes in urban development conditions in the most recent period have led to a new phase of urban policy innovation, with policies for advanced services at the heart of much of this experimentation. these new policy conditions include the following processes, trends, and events: . continuing processes and pressures of globalization, stimulating local and regional policies promoting competitive advantage at the city-region level (as well as wellpublicized protests and demonstrations), but also encouraging interest in the possibilities of co-operative programmes between cities and local governments situated within 'extended metropolitan regions ' (mcgee et al., ) . . the severe (although spatially differentiated) impacts of major exogenous shocks on regional and national economies, including the aftermath of the / experience in new york, the bali night-club explosion of october , and the lingering effects of the fiscal and economic crisis in the asia-pacific. these impacts have included inter alia sharply diminished air travel and tourism in many regions, increasing unemployment, and problems of corporate illiquidity and bankruptcies. we can also acknowledge the recent impact of sars (severe acute respiratory syndrome) upon major asia-pacific service industries, notably airlines, hotels and retail trade. . economic and developmental implications of a series of unresolved security crises within asia and the middle east especially, including the apparently intractable palestinian question, the iraq crisis, and the problem of north korea's incipient nuclear capacity. these implications include a more problematic investment climate within affected nations and proximate regions. . the rapid rise (and even more dramatic contraction) of the so-called 'new economy', over the last years. the collapse of the dot.coms notwithstanding, however, information and telecommunications industries constitute essential features of all advanced economies, and are playing increasingly central developmental roles within the asia-pacific region (corey, ) . . the emergence of the 'urban cultural economy', underpinned by what allen scott describes as the convergence of culture and urban development, and comprising both cultural production and consumption as leading sectors within a growing number of cities and city-regions (scott, ) . cultural industries (including creative design industries, media and multimedia, and film, video and music production) represent increasingly important sectors of the urban economy, in cities such as los angeles, tokyo, kyoto, singapore, bangkok, and melbourne. . sharply divergent economic fortunes of the asia-pacific's major nation-states, including the remarkable growth of advanced industrial production and trade in china, the continuing japanese economic malaise, and slow growth in the american economy (the stagnation of american consumer markets has also seriously retarded exports from other asia-pacific nations.). . continuing processes of restructuring and transition among the advanced economies of east and southeast asia, including taiwan, south korea, and singapore, as well as in 'threshold' nics such as malaysia, thailand, and vietnam. to illustrate, an "important feature of asean economic development has been the growth of their services sector" (tongzon, : ) , as reflected in gdp and employment data. . new phases of development within the industrial structures and space-economies of asia-pacific city-regions, exemplified by processes of accelerated tertiarization, decentralization, and multinucleation among major chinese coastal city-regions (yeh and wu, ) , and by the emergence of 'new economy' clusters within inner city sites of cities such as tokyo, singapore, san francisco, and vancouver. . increasing awareness within the asia-pacific of ecological implications of accelerated development (and more particularly rapid industrialization), including resource depletion and overall environmental degradation, stimulating interest in principles of sustainable development. . exacerbation of urban social problems (increasing income disparities, social polarization, and community dislocation), both in rapidly growing states (notably china) and also in some lagging countries and regions within the asia-pacific. these social costs are discounted by some as inevitable outcomes of rapid economic growth, but there has also been evidence of interest in exploring possibilities for reducing social inequities, both in terms of new socio-political 'compromises' at national government levels (scott et al., ) , and also commitments to social planning as an integral feature of local government and administration. this illustrative listing of new development conditions inevitably masks quite highly differentiated experiences at the national, sub-national, and local levels, but may provide a backdrop to a new phase of experimentation in policy formulation and institutional innovation. clearly, these development conditions will influence new planning choices and directions across the full range of local and regional policy domains. in the aggregate, these conditions tend to 'stretch' local policy capacity and to place increasing pressure on urban planning systems, staff and resources. however, there may be promising opportunities for policy experimentation within the realm of the urban service sector, in light of the increasing centrality of service industries to trajectories of urban development, and the far-reaching implications of tertiarization for urban form and the built environment, the metropolitan space-economy, and the city's social structure (as well as derived demand for housing and transportation). in chapter we will explore some of the leading models of urban policy for service industry development within the broadly defined asia-pacific region. planning for new trajectories of services-led urban development as observed previously, urban planning and policy responses to tertiarization within the asia-pacific region include ambitious programmes which deploy service industries as instruments of development and transformation. a review of urban policy experiences over the last decade and a half discloses explicit associations between services (especially advanced, specialized and intermediate service industries) and plans for globalization, restructuring and modernization. while the mix of policy measures varies from place to place, these service industry programmes typically incorporate substantial public investments, inducements to attract private capital and the commitment of market players (foreign and domestic), adjustments to regulatory regimes, spatial planning elements, and sets of ancillary policies, notably in transportation and housing. the record of these ambitious (and even grandiose) policy initiatives includes some significant successes, in terms of the basic transformational aims (and business objectives of market actors), although the experience is also replete with examples of institutional conflicts and tensions. these include 'structural tensions' in some cases between local agencies mandated to vigorously promote growth and change, which tend to embrace narrowly economistic principles and objectives, on the one hand, and local planning departments which may prefer more holistic programmes, with broader, more inclusive public purposes. there may also be conflicts between central and local governments concerning policy preferences for service industries and economic development more generally. aside from these institutional tensions there are also growing concerns about social and environmental implications of rapid urban economic growth and transformational change. these include social costs such as community dislocation and social polarization, as well as environmental impacts which may include the destruction of heritage buildings within areas undergoing rapid change, encroachment of cities on adjacent agricultural and natural terrains, and the degradation of air and water quality within the regional biosphere. there are also examples of growing awareness of the financial and ecological costs of intense inter-city competition for investment, new service industries, and employment generation, which in some cases takes the form of a proliferation of facilities within extended metropolitan regions (as exemplified by airport development within the pearl river delta). these more problematic features of accelerated urban growth and transformation, coupled with the changing development conditions identified in the conclusion of chapter in britain this institutional tension at the local level is exemplified by the (sometimes conflictual) relationships between local 'regeneration' agencies mandated to promote new investment, industry, and job creation, and the local planning departments which perform a range of regulatory and management functions. similar tensions between local development agencies and municipal planning departments can be observed in west coast cities of north america, including vancouver. with respect to institutional tensions between local and central governments within the asia-pacific, we can cite the recurrent conflicts in development aspirations between the okinawa prefecture and tokyo ministries over the nature of okinawa's growth and change, exacerbated by structural problems of core-periphery asymmetry and dependency, as well as the increasingly problematic us armed forces bases on the principal island. , have stimulated new interest in planning innovation at the metropolitan and local government levels within the broadly defined asia-pacific region. while urban policies emphasizing transformational growth and change, underpinned by globalization and modernization aspirations, and by imperatives of competitive advantage, are still pervasive within the region, we can also discern significant interest in alternative (and perhaps more progressive) urban planning models. these include, for the purposes of illustration, experiments in sustainable urban development, community economic development (ced), and co-operative regional development. the purpose of this chapter then, is to depict the breadth of urban policy initiatives involving programmes for service industries, at the city-region and local levels, underscoring the dominance of transformational policies throughout much of the region, but disclosing as well interesting (and potentially significant) policy experimentation and innovation. while a comprehensive description of urban service industry approaches (and the programmatic details of these policies) is beyond the scope of this paper, it may at least be possible to structure a number of the leading models for comparative purposes. accordingly, table depicts six strategic policy models which deploy service industries as important instruments or modalities, together with some representative programme elements, underlying principles and values, and exemplary reference cases within the asia-pacific urban network or hierarchy. accordingly the framework of urban policy models depicted in table includes three ensembles associated with the dominant developmental paradigm of the latter period of the th century (associated with globalization aspirations, industrial restructuring, and modernization), and a set of three policy models which reflect current or emerging directions which seem to offer more progressive developmental possibilities. these latter three urban policy ensembles include policies for service industries which emphasize possibilities of co-operation with the broader regional setting, examples of initiatives which support the idea of the 'sustainable' city-region, and, finally, planning for the new urban cultural economy, acknowledging what allen scott describes as the strategic convergence between culture and urban development (scott, ) . what follows is a description and concise discussion of each of these defining urban policy models. over the past two decades both local and senior-level governments have deployed policies for certain service industries as key instruments of globalization (or internationalization) strategies within the asia-pacific region. objectives in this policy realm have included overcoming scale limitations of local markets and regional entrepôt roles (e.g. singapore and vancouver in the s); integrating regional and national economies within global markets, to attract foreign capital and promote modernization within the domestic economy (as in the case of certain chinese coastal cities since ); and pursuing strategic trade and co-operation partnerships with selected foreign cities (for example fukuoka since the early s). inter-city competition, concepts of competitive advantage, urban hierarchy; discounting of social costs (daniels, ) singapore (since mid- s); shanghai, osaka, fukuoka deregulation/privatization foreign direct investment urban mega-projects (after olds, ) service industries and 'postindustrial' trajectories pursuit of 'growth services' and propulsive intermediate service industries within context of industrial decline/obsolescence; acceptance of dislocation and displacement effects (hall, ) nagoya, hong kong, singapore land use policy change human capital investments targeted industry support programmes service industries and the 'new economy' assertive technocratic vision which privileges the future; idea of it as principal instrument of urban transformation and modernization; 're-imaging' of the city via policyinduced technological development (bunnell, ) kuala lumpur-putrajaya, singapore, vancouver support for r&d promotion of urban 'technopoles' spatial planning and land use policy service industries and the 'cooperative regional cluster' model acknowledgement of complementarity (as well as competition) among centres within extended metropolitan regions (emr's), after mcgee (douglass, ) hong kong/pearl river delta, sijori, san francisco-bay area region institutional co-ordination joint planning and marketing efforts spatial rationalization of new investment service industries and the 'sustainable city-region' model principles of social and environmental policy; idea of 'efficient and equitable' city-region; acknowledgement of sustainability as planning paradigm or framework (goldberg and hutton, ) sydney, vancouver, pearl river delta planning for suburban service industry subcentres services within 'compact' and 'complete' communities extensive designated 'green zones' service industries and the urban 'cultural economy' idea of strategic convergence between culture and urban development (scott, ) ; significance of creative industries and workforce (florida, ) los angeles, singapore, vancouver public support of the arts policy support for inner city clusters heritage planning promotion of the ' h' city we can identify a distinctive range of policy modalities that have been introduced to exploit the globalization potential of advanced, specialized service industries and institutions within the asia-pacific region. these have included: (a) building capacity in strategic urban transportation and communication, infrastructure and facilities, such as seaports, airports, and teleports; (b) promoting the export of specialized services (such as 'producer' and other intermediate services), in order to exploit local comparative advantage in services to replace diminished goods export capacity, to improve terms of trade, and to achieve greater scale economies within regional industries; (c) stimulating the globalization of cities in situ, as exemplified by the series of urbanmegaprojects (umps) within the region which have included important service industry elements, such as the pudong ump in shanghai (olds, ) , and the mm ump in yokohama, which tend to promote the inflation of local land markets, the increased presence of foreign firms and multinationals in the central areas, and the comprehensive re-imaging of the city; and (d) exploring the possibilities of mutual benefit through reciprocal, two-way trade in services (including educational and cultural services, as well as in business services) with designated cities as elements of international 'sister cities' or 'city partnerships', exemplified by fukuoka's 'global reach' programme (fukuoka municipal government, ) , and the city of vancouver's 'strategic cities' programme (city of vancouver, ). clearly there are important, substantive economic development and trade purposes associated with these globalization strategies, but there are also (explicit or implicit) reimaging aspirations in many cases. the classic example within the asia-pacific is the restoration of shanghai as a global centre of finance, corporate control, and business services, supported by assertive regional and central government policies and programmes, massive foreign investment, and the conscious engagement of elite international architects, planners, and developers in shanghai's accelerated transformation olds ( ) . other examples include yokohama's goal of escaping a constrained role as tokyo's 'shadow city' by means of the ambitious mm docklands scheme, as well as osaka's search for a larger international profile, to be furthered in part by the redevelopment of the cbd and the massive osaka -kansai international airport project. these urban globalization strategies have been centrepieces of local and regional development strategies for an increasing roster of asian-pacific cities over the past decade or so, with commensurate heavy commitments in local financial, policy, and human resources. in light of these major investments, a number of these globalization programmes have achieved a measure of success, in terms of accelerating growth, integrating cities within global markets, and other essentially economistic goals. however, there have also been significant social and environmental costs associated with these programmes, and high levels of local exposure to a variety of risks, as social and ecological values have (despite policy rhetoric to the contrary) been substantially discounted against the perceived benefits of accelerated globalization (see douglass ( ) for a treatment of the tokyo case study). the single-minded pursuit of transformational urban development through market integration, enhanced (or induced) comparative advantage in export service trade, and comprehensive local re-imaging has led to large-scale community displacement and dislocation (as in shanghai), high corporate and municipal financial exposure (yokohama's mm project, and tokyo's waterfront development), and inflation in local property markets (many instances throughout the region). these significant social and environmental costs tend to be associated with the more comprehensive, grandiose projects. correspondingly, more selective, smaller-scale or 'managed' internationalization programmes are likely to generate fewer such costs. again, examples of these more selective internationalization programmes would include the fukuoka experience, in which mutual benefit between urban communities represents an explicit aim; and the vancouver case, in which the city's internationalization programme in the s included both considerable stakeholder input, and measures to ameliorate social costs of accelerated urban globalization (hutton, ) . the development record of most cities within 'advanced' societies over the last three decades or so includes generally increasing shares of employment, gdp and exports accounted for by service industries. there have of course been debates about whether this trend toward the tertiarization of the urban labour force, output and trade represents a 'natural' process or progression, but what is incontestable is that some cities have endeavoured to accelerate the shift from basic manufacturing to services, especially specialized and intermediate service industries and employment. as noted briefly in preceding chapters, the asia-pacific region encompasses numerous case studies of this policy preference. central to the policy values underpinning urban programmes for restructuring which favour service industries and institutions is the (explicit or implicit) endorsement of the 'post-industrial thesis', first enunciated by the american sociologist daniel bell, which postulated a pronounced shift from goods to services production as a defining feature of advanced urban societies. (see table (a) and (b) for a more comprehensive set of urban tertiarization attributes). as kong chong ho has observed, cities have been obliged to respond to restructuring processes (ho, ) , including retraining programmes for displaced workers, and welfare programmes and transfer payments as well as policies to promote industrial restructuring as part of modernization strategies (hall, ) . in a number of cases, urban programmes of accelerated tertiarization have been undertaken within a context of urban-regional industrial decline or obsolescence. this has been observed within the japanese metropolitan system, where the 'hollowing out' of the national industrial economy has been deeply felt, in terms of factory closures (or relocation offshore) and protracted structural unemployment. for some of these cities, new service industries and associated labour cohorts, production and trade constitute a possible new urban development trajectory or 'vocation'. as noted earlier, too, urban development planning and programmes have been influenced by research which has established certain advanced services as urbanregional 'propulsive industries', based on associated productivity measures, inputoutput relations and sales and employment multipliers, export propensity, and skilled labour formation. here, the large-sample survey of export services undertaken by beyers et al. in the mid- s for the seattle-central puget sound economic development district (cpsedd) has been especially influential in providing an empirical justification for services-oriented metropolitan development strategies (beyers et al., ) , complemented by theoretical work undertaken by peter daniels, jean gottmann, and others. important case studies of accelerated tertiarization within the asia-pacific include singapore, hong kong, and nagoya. in the case of the former, a short but sharp recession in the mid- s stimulated a comprehensive policy research exercise in singapore, culminating in an important development policy shift favouring intermediate services with high export propensity (or potential). underpinning this defining policy shift was the work of a special subcommittee exploring the merits of manufacturing-versus services-led urban development and growth. the subcommittee concluded that advanced, specialized services enterprises "contribute about twice as much value-added as manufacturing firms" (clad, ) , and constituted a more promising growth sector than most forms of goods production. accordingly the government of singapore embarked upon a comprehensive programme to accelerate growth in specialized services in , including incentives for foreign investors, new expenditures in education and training, sweeping fiscal changes (including major tax cuts, and reductions in payroll taxes), service industry support programmes, and marketing and information strategies. in hong kong over the same period the colonial government was also engaged in policy support for an increasingly post-industrial economy and workforce. as observed by bruce taylor and reginald win-yang kwok, this accelerated tertiarization strategy comprised important policies for urban structure and land use, including major land reclamation in wanchai and causeway bay to accommodate the expansion of hong kong's cbd, the ongoing industrial new town programme in the new territories to enable relocations from the central district and kowloon, and new investments in rapid transit (taylor and kwok, ) . as a measure of the effectiveness of this programme (coupled with the influence of market-driven change), services now account for over fourfifths of hong kong's labour force, and there is more employment in intermediate (or business) services than in consumer services (asian development bank, ) . in both the hong kong and singapore examples it can be argued that these policy shifts essentially reinforced (or accelerated) post-industrial urban vocations already in progress. however, the experience of certain japanese cities offers a quite different set of policy conditions and experiences. david edgington has written extensively about the role of industrial restructuring policies for the important nagoya -chukyo region, a key part of japan's industrial heartland. he depicts schematically a progression of new industrial vocations for chukyo over the second half of the th century, which includes (first) a mix of heavy industry (aircraft production and munitions) up to the s; secondly, a shift to heavy industries (steel and petrochemicals) and consumer products over the s; followed by strong growth in auto production (toyota), heavy engineering, and light industries during the s and s. however, the last decade in the nagoya -chukyo region has seen new local (prefectural and municipal) policies and planning in support of a 'new vocation' of knowledge-intensive industries, including aerospace, advanced electronics, new ceramic materials, information technology, biotechnology, and fashion design and production (edgington, : ) . this new vocation builds upon the nagoya -chukyo region's embedded excellence in advanced industrial production, but with greatly enhanced services, design, and technology inputs to production. here, the role of local government (as distinct from the well-known national government industrial support programmes) has emphasized "strengthening regional culture, design and general amenity upgrading for chukyo" as an "important part of regional restructuring" (edgington, : ) . the nagoya -chukyo experience represents an example of complementarity between central and local governments in promoting industrial restructuring at the regional level. the emergence of a 'new economy' characterized by propulsive roles for advanced information and communications technologies (ict), although to be sure a contested concept, has stimulated considerable interest among governments and policy communities within the asia-pacific. for a number of jurisdictions, policies for supporting ict are seen as means of rejuvenating urban and regional industrial production sectors (notably in japan), while in others investments in ict, implemented by spatial planning, land use, and human capital planning programmes, provide a means of 'leapfrogging' stages of economic development (malaysia). technology-driven development has also been central to new urban development experiments, as in the case of the tsukuba science city in japan. as a planning preference, support for accelerated ict development and other new economy activity can be seen as the endorsement of an assertive technocratic vision of urban and regional development, as observed by manuel castells in his discussion of 'the informational city' (castells, ; scott, ) . ict is deployed as a key instrument of urban transformation and modernization, with both 'substantive' effects (higher productivity and value-added production; business start-ups and labour formation) and 'symbolic' outcomes (re-imaging of local/regional societies and economies), although there are to be sure concomitant costs and dislocations (bunnell, ) . within the asia-pacific, we observe a number of instructive examples of ict-driven development strategies at the urban and regional levels. there are of course the globalscale advanced-technology regional complexes of silicon valley and orange county in california, seen as essentially 'spontaneous' (i.e. market-driven) enterprises, although the role of state-supported universities and other public agencies should be acknowledged. then there are the large r&d formations (applied research, prototype development) within japan, largely funded by major japanese multinationals and industrial conglomerates, but also influenced significantly by central government ministries and agencies. these massive american and japanese r&d complexes have of course been established for many years, and represent in some ways an earlier model of technologydriven spatial development linked to large industrial corporations. a number of other, newer examples of new economy exhibit in some respects different attributes, including larger roles for government and public agencies, more emphasis on integrated service industry engagement (including creative and design services, as well as financial, business, and communications services), and contrasts in scale. the range of examples in this more recent cohort of technology-driven enterprises varies from the extensive putrajaya -cyberjaya project in malaysia, described by kenneth corey as a defining project of malaysia's national economic development programme (corey, ) , to a series of inner city new economy experiments within a large and growing number of cities, including singapore and vancouver. these recent inner city new economy projects are clearly differentiated from the 'first generation' urban and regional technopoles in a number of ways, not only in the matter of scale, location, and provenance, but also in the mix of industries and activities. key to these new inner city formations is the concept of the metropolitan core as a special, in some ways unique, 'innovative milieu', providing advantages of socio-cultural, as well as economic, agglomeration, to constituent firms. there is also, as noted, a stronger service industry element, as in both the singapore and vancouver examples the explicit strategy involves fostering developmental synergies between technology (especially ict), culture (in the form of creative and design service industries), and 'place', as expressed in the innovative milieu of the inner city. these inner city new economy sites are characterized by intense interaction (formal and informal), deployment of both 'placed-based' and 'cyber-based' production networks, and a distinctive demography, emphasizing mostly younger creative and technological workers and entrepreneurs. . . . service industries and the 'co-operative regional cluster' model as is well known, the development experience of the asia-pacific region over the past four decades has been characterized in large part by prevailing attitudes of competition for shares of investment, trade, and new employment formation, between (and among) nationstates, regions, and even cities. this animating sense of competition between jurisdictions has at times been exacerbated by contrasts in stages of development, by ideological factors, and more forcefully by the pressures of accelerating globalization. development policy postures have therefore in many cases been influenced by a perception of regional development opportunities as a 'zero-sum' process of clear 'winners' and 'losers', leading to an emphasis on nurturing localized positions of competitive advantage (douglass, ) . assumptions of development as an essentially competitive process are of course still powerful influences on policy formation within the region, but there are also significant (and likely expanding) movements toward inter-jurisdictional co-operation, shaped by progressive ideas of reciprocal trade benefits, knowledge-sharing, and developmental complementarity. this is seen at the broadest spatial scale in the establishment of the apec grouping, an association which endeavours to promote liberalized trade and cooperative development within the pacific sphere (as well as providing a counterweight to other continental-scale bodies, notably the eu and the nafta states). at the regional level asean provides a forum for dialogue and trade co-operation among the states of southeast asia. then there is a steady proliferation of less formal regional co-operative associations, including a number of such entities in northeast asia (kim, ) , and joint international development projects, exemplified by the sijori (singapore-johore-riau) growth triangle in southeast asia, and the tumen river area development project in northeast asia (marton et al., ) . many of these developmental arrangements are replete with significant institutional asymmetries and tensions, but they may suggest the possibility of greater tendencies toward regional co-operation, perhaps working over the longer term to approach the levels of engagement and co-operative commitment of the 'associative regions ' (mcgee et al., ) of the eu. more specifically, it may be possible to envisage regional co-operation arrangements based in part on the functional complementarities of regionalized service industry clusters and corridors, described in chapter . as will be recalled, it is possible to identify at least conceptually ten major service clusters or corridors within the asia-pacific, each containing multiple cities and important ensembles of specialized service industries, institutions, and facilities. as in other co-operative ventures at the regional scale, there is an initial need for governments, business interest, and other stakeholders to recognize and acknowledge possibilities of complementarity and mutual benefit associated with these complexes of specialized service industries. in the absence of joint governance, common taxation regimes, and revenue sharing (in addition to issues of (for example) labour market standards and environmental norms) these co-operative regional arrangements may be problematic, but the difficulties may not be insuperable. indeed, the nature of service industry specialization may in many cases lead itself to a broader recognition of co-operative possibilities, even in cases where inter-jurisdictional competition has been the prevailing spirit. co-ordination of investments, operations, and marketing for strategic transportation and communication facilities, for example, can enhance the comprehensiveness of 'gateway' functions for an extended regional corridor or cluster. co-operative planning and programmes for regional tourism initiatives, involving a diverse range of assets, amenities, and hosting infrastructure (e.g. hotels and convention centres) which offer greater potential attraction to visitors than the individual, localized sites within the region, can yield mutual benefits. potentially these principles of co-operation and co-ordination could apply in other important service sectors and industries, for example higher education and specialized health case, acknowledging the advantages of 'packaging' services and expertise offered by diverse firms and institutions within extended regional territories. through greater levels of co-ordination and planning of specialized service functions, regions can achieve stronger competitive positions within international and global markets. within the asia-pacific, the hong kong -pearl river delta offers a particularly instructive case study. following the economic reforms introduced by deng xiao-ping in , the pearl delta experienced extraordinary levels of growth in investment, business start-ups, employment formation and physical development. much of this growth was in the goods production sector, especially light manufacturing, but (as observed in chapter ) the prd also experienced rapid expansion in services. however, there was a chaotic pattern to much of this development, as evidenced in the growth of the shenzen special economic zone (sez), and in the proliferation of new airports within the delta. this period of rapid growth was also characterized by an almost 'free for all' competitiveness among the urban centres of the region. although the prd has experienced high levels of growth over the past two decades within an essentially competitive context, there is significant evidence of co-operation and co-ordination in recent years, especially since the establishment of the hong kong special administrative region (sar) following the reversion of the former crown colony to china in . these efforts to pursue co-operation in economic development have been documented in a recent book edited by anthony gar-on yeh et al. ( ) , titled building a competitive pearl river delta region: co-operation, co-ordination, and planning. to some extent, of course, this desire to achieve co-ordination is related to the need to avoid wasteful, inefficient duplication of functions, to preserve resources, and to rationalize spatial planning in a congested, high growth region. there is also a need to 'manage' competition between the two major centres of the region, hong kong and guangzhou (kwok and ames, ; cheung, ) . however, an important principle underpinning the increasing levels of co-operation within this administratively fragmented and complex region is the exigency of responding to pressures (and opportunities) of globalization. in this respect, the pearl river delta contains both a dense pattern of manufacturing and industrial production, as well as concentrations of specialized service industries, institutions, and functions, including banking and finance, seaports, airports, higher education, cultural and creative services, and public administration. these specialized services represent the best prospects for future growth and development in the region, and greater co-operation and co-ordination of these key services can significantly strengthen the prd's competitive position within east asia and global markets. there is considerable potential for co-operation in the planning and development of other major regional service clusters and corridors within the asia-pacific. the basic idea is to explore means of managing competition between service industries and installations within regional settings, while capitalizing on functional complementarities to achieve stronger international competitiveness. much of the regional co-operation within the region over the past years has been undertaken for areas specializing in manufacturing and industry, as in the sijori and tumen river area projects cited earlier. however, given the momentum of tertiarization within the asia-pacific, and the strategic global functions performed by certain service industries, institutions, and firms, co-operative management and co-ordination of regional service clusters present especially promising possibilities for future urban and regional development within the asia-pacific sphere. there is a need to strengthen regional governance and administration as a pre-condition, however, as the lack of effective regional institutions represents a major constraint. as an example, the association of bay area governments (abag) in the san francisco bay region provides a forum for inter-jurisdictional dialogue and a certain amount of coordination, but lacks the capacity to promote effective regional development co-operation. in addition to the transformational roles described earlier, service industries are increasingly deployed as key elements of spatial and land use planning within the asia-pacific, including a new generation of regional plans influenced by principles of sustainable development. although the specific forms of these new city-region plans of course vary from place to place, we can discern features of three important traditions of spatial (or physical) planning, as follows: (a) elements of spatial planning derived from the classic 'containment' model of planning for metropolitan city-regions, incorporating stringent development control on commercial development in the central city, the establishment of green belts or zones, and the designation and development of new (or expanding) towns on the regional periphery, as seen in the post-war planning of london and the south east region of england (hall et al., ) , and updated in the sequence of 'structure plans' for english counties in the s; (b) attributes of 'new urbanism' planning models (and related concepts) introduced in the s, which included the ideas of 'compact' (as opposed to dispersed) and 'complete' (in contrast to dormitory) communities within city-regions, an emphasis on transit-oriented development (tod) (and the increased management of automobile traffic), and a preference for 'traditional' (or 'neo-traditional') housing styles and vernaculars; and (c) principles of 'sustainability' (or 'sustainable development'), which have increasingly influenced the planning of city-regions (as well as 'natural' or 'resource regions') since the rio 'earth summit' of , and which encompass ideas of ecological preservation, biodiversity, the integrity of ecological systems, and the need to manage (and eventually reduce) the human 'ecological footprint'; i.e. the impress of human activity on the world's natural resources and biosphere. in the urban context, sustainability principles can also be applied to the city-region's economy, culture, and social 'capital'. the extent to which principles derived from these major models of urban and regional planning is dependent not only on considerations of urban scale, environmental setting, industrial structure, and growth rates, but also on the structure of urban governance, the nature of political control, characteristics of the local planning system and policy agencies, the quality of leadership, and other institutional factors. at the broadest level, however, there is a kind of structural tension associated with contemporary spatial planning for metropolitan regions, between the need for flexibility to accommodate changing locational demands of business and industry (including the so-called 'new economy' activities) and new residential preferences, on the one hand, and the imperative of deploying policies to impose a measure of order on the growth of human settlements, in accordance with ecological and social values. service industries have been assigned roles within each of the three principal spatial planning ensembles cited earlier, although these have been demonstrably subject to change. within the 'first-generation' containment models growth management, development control, and the accommodation of population growth by means of supporting designated regional centres were dominant aims, and services (including offices) were addressed primarily by a suite of regulatory policies in the early post-war programmes, as described in chapter (goddard, ) . however, a 'second generation' of regional plans in the s, derived from the containment model in britain, canada, and numerous other states, included the idea of rtcs (or commercial subcentres), within which office development and firms were assigned important roles. these new suburban or regional subcentres were intended to attract new office development, not only to manage development pressure on the cbd, but also to provide more employment opportunities in areas of rapid population and labour force growth, thereby also reducing commuting pressures. within the rubric of new urbanism, offices and other service industries were also seen as important spatial planning elements. to illustrate, concentrations of relatively high-density service development can enhance prospects for the formation of 'compact' (as opposed to dispersed and low-density) communities, while the inclusion of service functions and employment were central to the implementation of 'complete community' strategies. finally, although sustainable development has emphasized the primacy of ecological values and environmental planning, service industries have a number of important implications for sustainability planning. the status of services as the most rapidly growing elements of many urban economies has ramifications for resource consumption (including land), while the mismatch between service employment concentrations and residential development exacerbates the metropolitan commuting and traffic congestion problems, impacting regional air quality. at the same time, the fortunes of the service sector and its constituent industries also have a clear connection to the socio-economic sustainability of the metropolis, especially in light of contractions in fordist manufacturing. . . . . experiences within the asia-pacific. the highly differentiated stages of development and local institutional arrangements among asia-pacific city-regions offer a rich array of experiences in policies for service industries within spatial plans. these include a substantial sampling of metropolitan cities which have deployed containment strategies or 'structure planning' concepts, incorporating the designation of secondary office-commercial centres or subcentres. this has been especially the case in jurisdictions strongly influenced by british planning models, notably australia, canada, singapore, and hong kong, but resonances of the containment model and its defining features (green belts, new residential communities, and designated service industry subcentres) are also discernible in japanese city-regions. we can also identify aspects of the new urbanism and sustainability models in a growing number of city-region plans, although in most asian cities the experience is in incipient stages. a (necessarily concise) selection of reference cases follows. as observed earlier, the location and development of service industries within guangzhou and the pearl river delta (as well as other fast-growing chinese cityregions) has become a major spatial planning issue over the past decade, and underscores the tensions between accommodating growth and the pursuit of sustainable development. within the guangzhou city-region, the combination of liberalized development policies, a greatly expanded role for the market, and high levels of growth have reshaped urban structure and land use over the last years, as disclosed in a recent empirical study by fulong wu and anthony gar-on yeh. during this period, there has been substantial redevelopment within guangzhou's central city, but its overall spatial reconfiguration "is changing from a compact city to a dispersed metropolis as a result of reforms which introduced land values and markets to its urban areas" (wu and yeh, : ) . a measure of this dispersal and sprawl consists of industrial estates, but new service industries and commercial development, driven in large part by foreign investors, also play a role in this process. as wu and yeh conclude, "[the] conflict between urban spatial restructuring and development control is inevitable" (wu and yeh, : ) in high-growth cities characterized by the decline of central planning and inadequate local planning powers. michael leaf goes even further, asserting that in these dynamic chinese cities, "the practice of urban planning may have passed from irrelevance under the command economy of the past to gross ineffectiveness in the socialist market economy of today" (leaf, : ) . moreover, local planning systems in at least some chinese cities are developing more sophisticated planning styles, and an increasing number of planning professionals are engaged in exploring sustainability principles, so it may be that the next generation of city-region plans will incorporate stronger elements of sustainable development. other reference cases within the asia-pacific provide quite different experiences of spatial planning and contrasting perceptions of the role of services in regional sustainable development. the evolution of spatial planning in metropolitan vancouver represents a sequence of new roles for service industries, from 'containment' to sustainable development. in vancouver's first regional plan, the livable region region - (approved , the classic elements of the post-war containment spatial plan were all present, including green zones (incorporating special protection for agricultural land, an emphasis on public transit, and the designation of four regional (suburban) town centres, each of which was to attract one million square feet of office space over the term of the plan. at the same time, the regional plan proposed strong development control policies for the cbd, both to ameliorate commuting and to enhance office development prospects for the rtcs (hutton and davis, ) . two decades later, a new livable region strategic plan (lrsp) ( ) affirmed the multinucleation strategy of the earlier plan, and indeed added several new rtcs, but also introduced policies for 'compact' and 'complete' community formation, influenced by the new urbanism spirit. service industries were allocated important roles in the lrsp, as the concentration of new offices in the (now eight) rtcs would support the principle of compact settlement forms, while a more diversified range of both intermediate and final demand services (including commercial, retail, and educational services) would promote the formation of complete communities within the city-region, integrating important service functions and local employment opportunities with residential development. more recently, a new public process has been initiated by the greater vancouver regional district, the regional planning agency for metropolitan vancouver, with a view to more vigorously asserting sustainability values and principles in the lrsp. this initiative includes the possibility of strengthening the (already-substantial) ecological conservation measures of the regional plan, but there is also a new emphasis on the importance of economic sustainability as a critical planning priority. in this new planning consultation process, key informants, stakeholders, and the general public are invited to propose new ideas for enhancing the economic sustainability of the region, including the spatial planning implications of new service industry development. these include the cbd (now seen as a unique and valuable regional assets rather than principally a generator of negative externalities, as interpreted in the metropolitan plan), the eight designated rtcs, the port of vancouver, vancouver international airport, the region's universities and colleges, and a number of 'new economy' sites, both in the suburbs and in the metropolitan core. spatial planning measures for service industries that promote multinucleation within metropolitan strategies can be seen as supporting economic sustainability (nurturing of high growth service industries, building capacity for industrial transition, enhancing regional economic resilience) as well as ecological sustainability (conservation of scarce urban land resources, mitigation of commuting-related air pollution). agglomeration of advanced service industries promotes the 'cluster-driven' process of advanced urban development, as seen in the vancouver example described earlier. other important examples within the asia-pacific include the global-scale concentration of advanced-technology service industries clustered in redmond, washington, within the metropolitan seattle-king county city-region, and the recent development of sydney's north shore high-tech corridor. this corridor has seen a functional and spatial evolution over the past four decades, initiated in the s by a secondary cbd in north sydney, at the north end of the sydney harbour bridge, followed by the establishment of a major regional shopping centre in the s, and the development of macquarie university on a nearby site (o'connor et al., ) . with these activities serving as a base, the last two decades have seen the dramatic growth of new technology-based industries and advanced services: the north shore corridor is anchored by microsoft corporation at one end, and cable and wireless optics at the other, with five commercial clusters situated between these two major poles (o'connor et al., ) . by the mid- s, employment within the north shore corridor exceeded , included jobs situated within member companies of the australian information industry association (o'connor et al., ) . sheehan quotes a property consultant as describing the north shore corridor as "technology land, but it's not physical production, it's brain power and computer power, biased toward sales, service and management rather than research, development and production" (sheehan ( : ) , as quoted in o' connor et al. ( : - ) ). clearly, on this evidence, market players (investors, entrepreneurs, and professionals) have been central to the development of sydney's north shore corridor, but government and public agencies have played leading roles in terms of regional spatial planning, municipal land use policy, and in tertiary education investment. the sydney north shore corridor experience also vividly depicts the functional evolution of service industry clusters over time, in this case from a secondary office and shopping centre to an incipient high-technology site, and finally to a large-scale 'new economy' site of national significance, including advanced-technology industries and specialized service functions. urban centres within the asia-pacific region, as elsewhere, have played important roles as repositories of signifying local, regional, and national cultures, as exemplified by cities such as beijing, kyoto, and hanoi, and many others. these important cultural roles are manifested in (for example) language and dialect, in museums, galleries and archives, in institutions of higher learning, in the built environment, and in social organizations and agencies. these cultural activities have economic as well as social value, as expressed in direct employment generation and incomes, tourism receipts, and the capital value of infrastructure, including heritage buildings. these traditional cultural roles continue to be important (albeit recurrently renegotiated by political acts and social experiences, and subject to new cognitive filters), but are now significantly augmented by fresh processes of reproduction, innovation, and economic development, both in the market and public domains. over the last decade or so, we have witnessed dramatic growth in a range of creative, design-based and 'new cultural' industries. as allen scott has observed in a well-known treatment of 'the cultural economy of cities', "[a]s we enter the st century, a very marked convergence between the spheres of cultural and economic development seems to be occurring" (scott, : ) . within cities, the expansion of this new cultural sector includes film, video and music production, graphic artists, industrial design, fashion design, and architecture, as well as 'hybridized' firms which combine creative and technological outputs toward products (goods and services) imbued with high design content, including multimedia and 'new media' activities, internet graphics and imaging, and software design. again to reference scott, "an ever-widening range of economic activity is concerned with producing and marketing goods and services that are infused in one way or another with broadly aesthetic or semiotic attributes" (scott, : ) . creativity is an essential element of the city's role as centre of innovation, in cultural, industrial, and intellectual realms (hall, ) . within the broadly defined asia-pacific region we can readily identify some leading exemplars of this 'new urban cultural economy', such as los angeles (film production and post-production, music, and media), tokyo (media and communications, architecture, design-based industries), seattle (software design, music production), hong kong (music, creative and design-based industries, media and communications), singapore (advertising and corporate branding, multimedia), melbourne (creative and design-based industries), and vancouver (graphic design and multimedia). the rapid expansion of these important new industries can be seen as the most recent development phase in the continuing evolution of the urban service economy, and the enduring competitive advantage of cities for specialized cultural production, as well as the reassertion of production activity in the inner city districts of some urban areas. moreover, these new forms of specialized cultural services production are characterized by a distinctive interface with consumer markets, as many of these industries supply what scott terms 'cultural products' (scott, : ) which influence public tastes and preferences, and are concerned with differentiating consumer market segments. the 'new cultural economy' represents a leading-edge urban policy area. within the mature urban societies of the atlantic core, there is a significant record of policy innovation. for example, within the eu, there are numerous programmes for both national and local governments to support cultural industries, including the annual designation of 'european cultural cities'. at the national level, the british government has produced detailed inventories of cultural industries, including employment, sales, and exports, as well as policy guidance for local authorities. in north america richard florida has written about the crucial importance of the 'creative class' of service workers for advanced urban economies, and has emphasized the need for progressive policies (liberal immigration policies, generous public support of the arts) to attract and nurture this creative workforce (florida, ) . within the asia-pacific, the new cultural economy should emerge as an increasingly important component of service industry strategies and more comprehensive economic development programmes. in singapore, the tourism board is active in promoting activities which intersect the new economy (technology-intensive industries) and the new cultural economy, including internet design firms, advanced design, and other creative services, concentrated within designated sites in chinatown, just west of singapore's cbd. as another example, far east properties has entered into an agreement with the government of canada, nortel networks, and the eu to sponsor a new business centre in another area of traditional chinese shop houses, just east of cross street, demonstrating again the possibilities of co-operative development in the advanced service economy. the refurbishing and subsequent 'recolonization' of these important heritage districts suggests that culture and social memory can be reconciled at one level with economic innovation, although there are of course sublimated tensions in these processes of transition and appropriation (see yeoh and kong, ( ) for insightful treatments of these issues). west coast cities in north america are also active in promoting the new cultural economy sector. los angeles and san francisco have agencies which promote new activity including these new cultural economy industries. in vancouver, the municipal government has undertaken comprehensive land use and rezoning to facilitate the transformation of a large ( ha) inner city site from traditional industry, warehousing and industry to new industries which interface with the technology and cultural sectors. this project includes a new campus (great northern way campus) comprising units of four vancouver-area universities and colleges, which has been established both to stimulate industrial innovation in the larger site, and also to encourage synergies between design-based and technology-based industries. there is also support for cultural and creative service industries among certain chinese cities. as observed earlier beijing's current plan strongly endorses the city's traditional cultural role, but there is also significant innovation in contemporary art and creative industries among beijing's universities and art schools (fackler, ) . in shenzen, a new three-year study of the city's dynamic cultural industries will include empirical research on clustering, linkage patterns (both place-and web-based), and the discourse of cultural landscapes, both to enlarge scholarly appreciation of these industries, and to inform policy (li, , personal communication) . on the other hand, the city of shanghai is demolishing the warehouses along suzhou creek which have provided a distinctive milieu for artists, artisans, and other creative workers. this eradication of shanghai's artist-loft district has been criticized as inimical to the fostering of cultural industries which complement the commercial functions of world cities, and to the emergence of an important 'spontaneous' (as distinct from induced) creative services cluster. lu yongyi, a professor urban planning at tongji university, has asserted that "[i]t will be too late when they realize these ruined communities were things of value that can never be rebuilt" (fackler, ) . by way of contrast, the residential high-rise towers which will replace the suzhou creek warehouse district, while meeting to be sure social needs, are replicated throughout the city, and could have been accommodated elsewhere in the comprehensive redevelopment of shanghai. finally, an increasing number of cities are exploring the ' h city concept' as a means of supporting the lifestyles of workers engaged in creative and 'hybridized' designtechnology enterprises. research has indicated that many of these professionals, artists, and entrepreneurs have irregular working hours, and are attracted by the h urban amenities of restaurants, night clubs, and all-night 'raves', as well as alternative recreations, such as skateboarding. these all-night activities do create tensions in residential areas within the inner city. here, there are possibilities for effectively integrating social planning, cultural programmes, and advanced service industry policies to nurture the development of these important new cultural and hybridized industries which constitute ascendant features of the st century inner city among advanced urban societies. conclusion: an agenda for scholarly investigation the purpose of this exploratory paper has been to establish tertiarization as an increasingly important process of urban development within the asia-pacific. the growth of advanced service industries will be crucial to the development of asia-pacific city-regions (and indeed to national economic progress) over the first decades of the new century. more particularly, advanced, specialized service industries will be central to employment and human capital formation, to the expansion of the urban middle class, to the more efficient operation of advanced industrial production systems and trade networks, and both to urban competitive advantage and the socio-economic sustainability of asia-pacific cities. reinforcing this latter point, many of the region's large industrial metropoles will begin to 'shed' manufacturing employment (as experienced in the wrenching deindustrialization of mature atlantic city regions, and in the 'hollowing out' of japanese manufacturing capacity), and will need services growth to partially offset these contractions. at the same time, growth in advanced service industries and employment will require greater public policy commitments, not only in the areas of infrastructure and supporting systems, and in land use policies, but also in education and training. here, we can return to an earlier comparative theme addressed in this paper, by acknowledging that effective policies for services (incorporating developmental as well as regulatory elements) have been seen as lacking in the old atlantic core coffey, ) , despite a relatively early experience of growth in advanced services within the region as a whole. the cities of the asia-pacific (and their respective central and regional governments) will need to develop more innovative policy approaches toward service industries over the next decade and beyond, reflecting the increasing significance of advanced services for economic transition and modernization. moreover, it must be acknowledged that policy selection in this sphere entails value choices (and conflicts). the facilitation of advanced services growth can, as we have seen in a number of asia-pacific cities, entail the dislocation of traditional industries, informal services, and residential populations. a balance must be struck between the imperatives of economic modernization and the claims of social justice, as well as respect for diversity and pluralism. a progressive urban planning posture should support the preservation of informal services and historic city districts, both of which sustain the authenticity of local identity, while at the same time promoting the intermediate, technology-based, creative and other specialized services essential to development. the idea of sustainable development, which has been articulated in some urban strategic plans within the region (at least at a rhetorical level), may present a progressive planning framework for integrating social, economic, and ecological values. recent research has disclosed that there may in fact be significant policy complements intersecting urban sustainability and competitive advantage, including policies for compact urban structure and land use, efficient transportation and transit, and education investments (goldberg and hutton, ) , which may inter alia support advanced service industry development, as well as enhancing social welfare and ecological sustainability. to some extent the expansion of service industries within the asia-pacific has assumed basic features of the earlier urban tertiarization experience within the mature regions of the atlantic core, but in other respects has been quite distinctive. these contrasts can be attributed in part to different models of intermediate services production and exchange, to the special roles of government policy in promoting accelerated services growth, and to the marked disparities in overall development at national and regional scales within the asia-pacific. these contrasts were identified and incorporated in our provisional typology of urban service specialization. the differentiated growth rates and levels of specialization in advanced services decisively influences urban hierarchy within the region, as well as patterns of services trade and exchange, and global city-region status (rimmer, ) . indeed, one of the salient issues for the future will be the extent to which full globalization processes may override established regional service markets, for example in finance, property and real estate, among others. the specialized service centres and corridors described earlier may emerge as platforms for the globalization of services produced within the asia-pacific, as well as engines of development within the region. the narrative suggests a mandate for scholarly inquiry into the growth and development of service industries within the broadly defined pacific realm, derived from attributes of the tertiarization experience which include ( ) relatively high growth rates of service industries and employment in an expanding number of pacific societies over the past decade or so; ( ) the larger developmental implications of rapid tertiarization, whether viewed as an important extension of industrialization, or as essentially a new phase of socio-economic development; ( ) the more specific consequences of rapid services growth for urban (and more categorically metropolitan) areas, and especially the role of tertiarization in processes of urban transition and transformation; ( ) the distinctive interface between public policy and market forces in the acceleration of service industry growth in many cities and regions of the asia-pacific; and ( ) the more problematic outcomes and impacts of service industry development within the pacific new core, including displacement and polarization impacts, exacerbation of globalization pressures on existing industries and local communities, and the special problems presented by the larger economic crises within east and southeast asia in particular, a phenomenon which has had serious consequences for the service industries of the region. no doubt other themes could be elucidated (beyers, ) , but even this necessarily selective inventory of strategic considerations presents a rich, stimulating and potentially consequential agenda for scholarly research. in addition to these empirical problems and policy issues, there are important theoretical questions to be addressed, associated with the role of tertiarization processes in the structure, growth and transformation of city-regions within the asia-pacific. there is a need to reconsider urban models embedded within the industrialization paradigm, in order to accommodate the increasing influence of service industries in the development of urban regions within the pacific realm. these theoretical exercises will naturally acknowledge the centrality of industrial trends and economic factors, but will ideally transcend narrow economistic parameters to consider both the social implications of services growth, as well as the socio-cultural basis of advanced tertiarization, following the lead of progressive urban scholarship both in the atlantic and pacific spheres (moulaert and gallouj, ; kim et al., ) . more specifically, there is a clear need for conceptualization of trajectories of service sector development within the asia-pacific which embody experiences of differentiation and exceptionalism that abound within the region, as well as more widely observed features. beyond this important theoretical terrain, urban scholarship should address the relationships between the location of service industries and the reconfiguration of regional structure and the metropolitan space-economy. innovative new research in this realm includes larissa muller's work on business services in southeast asia, incorporating commentary on opportunities 'for localizing international investment' within the region (muller, ) . at the larger metropolitan scale, these models would position services as decisive influences on multinucleation, and would encompass spatial linkages between advanced services and manufacturing enterprises in regional production systems. at a more localized level, new urban spatial models should incorporate the emergence of emerging clusters of specialized services within reconstructed precincts of the inner city, including constituent ensembles of integrated services production networks. this should include research on the 'new economy' industries and cultural and creative activities which comprise the most recent phase of urban service industry development. finally, we can identify rich potential for socio-economic models of urban tertiarization that depict the role of services in social change within the region. there is an opportunity to investigate the hypothesis of a 'new middle class' (ley, ) as an ascendant social constituency among those asia-pacific cities which have experienced rapid growth in services. another research frontier concerns the new social divisions of service labour within asia-pacific cities, reflecting the convergence of culture, technology and urban milieu, observed in a growing number of new service production spaces within the region. then there is the overriding influence of global processes on the occupational and social structures of urban communities, including the role of mncs, the changing international division of production labour, innovation in telecommunications, and international migration. the extent to which these three powerful sets of forces-an ascendant new middle class of elite service workers, emerging social divisions of service labour, and globalization processes-influence social change and exacerbate social polarization tendencies within asia-pacific cities will surely assume greater theoretical and normative importance over the next decade and beyond. australian cultural diversity and export growth, office of multicultural affairs, canberra. asian development bank social transformations in the global city: singapore the coming of the post-industrial society services and the new economy: elements of a research agenda the service economy: export of services in the central puget sound region multimedia utopia? a geographical critique of high tech development in malaysia's supercorridor tropes of transboundary economic regions and the problems of greater china the informational city: information technology, economic restructuring, and the urban-regional process the expatriatisation of holland village building a competitive pearl river delta region: cooperation, coordination, and planning the yangtze delta metropolis. paper presented to a joint meeting of the chs-ubc asian the business of living in singapore modernism and the vernacular: transformation of public spaces and social life in singapore city of vancouver, . an economic strategy for vancouver in the s long-neglected services get new attention employment growth and change in the canadian urban system the new international division of labor, multinational corporations and urban hierarchy information technology and telecommunications policies in southeast asian development: cases in vision and leadership intelligent corridors: outcomes of electronic space policies office location: an urban and regional study report of the working group on tertiary industries, metropolis association economic development and producer services growth: the apec experience globalization, producer services and the asian city the planning response to urban service sector growth some planning implications of the expansion of the urban service sector london's and new york's response to the asian financial crisis the future of cities on the pacific rim transnational capital and the social construction of comparative advantage in southeast asia the 'new' tokyo story: restructuring space and the struggle for place in a world city the 'developmental state' and the asian newly industrialized economies globalization, intercity competition and civil society in pacific asia. keynote address to workshop on southeast asian urban futures, centre for advanced studies socializing the modern vietnamese family new strategies for technology development in japanese cities and regions economic restructuring in yokohama: from gateway port to international core city planning for technology development and information systems in japanese cities and regions planning for industrial restructuring in japan: the case of the chukyo region, centre for human settlements the death of shanghai's sotto. the globe and mail (toronto) the rise of the creative class world city formation: an agenda for research and action a world city and flexible specialisation: restructuring of the tokyo metropolis industrial districts and economic development in japan: the case of tokyo and osaka global reach, international relations section china's coastal cities: catalysts for modernization edge city: life on the new frontier the japanese technopolis programme: high-tech development strategy or industrial policy in disguise? the future of canadian city-regions: intersections of urban sustainability and competitive advantage megalopolis: the urbanized northeastern seabord of the united states urban centrality and the interweaving of quarternary activities the world cities, weidenfeld and nicolson the restructuring of urban economies: integrating urban and sectoral policies cities in civilisation, weidenfeld and nicolson the containment of urban england the human side of development: a study of migration, housing and community satisfaction in pudong new area, peoples republic of china chinese cities and china's development: a preview of the future role of hong kong the expanding role of hong kong as a service centre. hang seng economic monthly city profile: nagoya studying the city in the new international division of labor, department of sociology working papers industrial restructuring and the dynamics of city-state adjustments industrial restructuring, the singapore city-state, and the regional division of labour corporate regional functions in asia-pacific blood, thicker than water: networks of local chinese bureaucrats and taiwanese investors in southern china a profile of vancouver's service sector, monograph prepared for a meeting of the metropolis service industry working group service industries, economic restructuring and the spatial reconfiguration of asian pacific city-regions the transformation of canada's pacific metropolis: a study of vancouver reconstructed production landscapes in the postmodern city: applied design and creative services in the metropolitan core the new economy of the inner city: processes, patterns, and planning issues the role of office location in regional town centre planning and metropolitan multinucleation: the case of vancouver location, linkages and labor: the downtown complex of corporate activities in a medium size city the capital city development in japan from collective economy to collective economy? spatial transformation in the pearl river delta in the post-reform period culture and the city in east asia last colonial spatial plans for hong kong: global economy and domestic politics planning for qiandian (front shop): metroplan of hong kong a framework for exploring the hong kong-guangdong link corporate strategies for the asia-pacific inner city neighbourhood development redevelopment before development: asian cities prepare for the pacific century, asian urban research network, centre for human settlements vietnam's urban edge: the administration of urban development in hanoi the myth of continents: a critique of metageography the new middle class and the remaking of the central city the service sector and metropolitan development in canada personal communication re: dr leilei li's project on cultural industries in shenzen changing theoretical perspectives on urbanization in asian developing countries china's industrialization with controlled urbanization: anti-urbanism or urban-biased? identity, mobility, and the making of the chinese diasporic landscape: the case of hong kong the persistence of proto-proletariat: occupational structures and planning of the future of third world cities labour force change and mobility in the extended metropolitan regions of asia the emergence of desakota regions in asia: expanding a hypothesis reconstructing the southeast asian city in a post-modern era. paper presented to the workshop on southeast asian futures, centre for advanced studies footprints in space: spatial restructuring in the east asian nics - the mega-urban regions of southeast asia from corridors to intercity networks: the role of emerging urban systems in building regional networks in northeast asia. paper presented to the fifth annual ubc-ritsumeikan seminar the urban restructuring process in tokyo in the s: transforming tokyo into a world city urban development and planning in beijing metropolitan region restless landscapes: spatial economic restructuring in china's lower yangzi delta. phd dissertation northeast asian economic cooperation and and the tumen river area development project tokyo as a global city the locational geography of advanced producer firms: the limits of economies of agglomeration advanced business services in southeast asia: an opportunity for localizing international investment the development and transformation of guangzhou, centre for urban and regional studies the economic transformation of american cities editor's preface, special issue of asia pacific viewpoint australia's changing economic geography: a society dividing globalization and the production of new urban spaces: pacific rim mega-projects in the late th century globalizing shanghai: the global intelligence corps and the building of pudong globalization and urban change: capital, culture, and pacific rim mega-projects where there is sugar, there are ants: planning for people in the development of batam, indonesia pacific asia in the global system economic and industrial development and its implications in the jakarta-bandung mega-urban area, department of regional and city planning making democracy work: civic traditions in modern italy southeast asia: the human landscape of modernization and development japan's world cities international transport and communications interactions between pacific asia's emerging world cities the global city high technology industry and territorial development: the rise of the orange county complex metropolis: from the division of labor to urban form the cultural economy of cities the cultural economy of cities global city-regions planning for cities and regions in japan ten kilometres of dot.com haven producer services development and trade: malaysia and asean in the uruguay round the new economy, allenheld and osmun territories, flows, and hierarchies in the global economy worlds of production: the action framework of the economy the autumn of central paris: the defeat of town planning - from export center to world city: planning for the transformation of hong kong the internationalisation of producer services and the integration of the pacific basin property market the economies of southeast asia: before and after the crisis hong kong's economic prospect in a changing relationship with china: a speculative essay services in asia and the pacific: selected papers, united nations asean-eec trade in services corridors: a theory of urban system urban spatial structure in a transitional economy: the case of guangzhou development of land use and urban planning of guangzhou, centre for urban and regional studies bangkok's restaurant sector: gender, employment and consumption shanghai: transformation and modernization under china's open policy building a competitive pearl river delta region: cooperation, coordination, planning portraits of places: history, community and identity in singapore changing southeast asian cities: urbanization and the environment in international perspective the culture of cities sources for this project included extensive site visits and field trips to cities within the asia-pacific; communication with numerous colleagues, and key informants; participation in conferences and special workshops; and a review of several distinct literature domains, including the services research literature, asian urban studies, and the urban change and transformation scholarship. visits to chinese and southeast asian cities were undertaken as part of a much larger asian urban research project managed by the ubc centre for human settlements, supported by the canadian international development agency (cida centre of excellence grant # -s ). this study includes references to research undertaken by colleagues within partner institutions in asia, as well as theses produced by ubc graduate students supported by this cida grant. site visits and study tours of japanese cities were enabled by grants from the japan foundation, the japanese ministry of education, and the ubc hampton research fund. fieldwork in san francisco was supported in part by a grant from the ubc vice-president's (research) discretionary fund. an exploratory workshop on 'service industries and new trajectories of urban development within the asia-pacific', involving many of the leading international scholars in service industry scholarship and in asian urban studies was convened at the university of british columbia in march, , generously supported by the peter wall institute for advanced studies, ubc. this workshop significantly contributed to new knowledge on the role of service industries in processes of urban change within the asia-pacific, substantially informed this current paper, and generated manuscripts to be included in a new book to be co-edited by peter daniels (university of birmingham), kong chong ho (national university of singapore), and me.i also want to acknowledge the generosity of the centre for advanced studies at the national university of singapore in making possible my sojourn as visiting scholar in july of . this enabled me to liaise with (new and existing) colleagues, to conduct fieldwork, and to present a selection of findings to a cas colloquium. in particular i would like to express my appreciation to brenda yeoh, k.c. ho, peggy teo, and kris olds of cas (the latter now at the department of geography, university of wisconsin at madison), and to henry yeung of the nus department of geography.finally, i want to acknowledge the essential contributions of ubc colleagues. michael leaf (director, centre for southeast asian research, and faculty associate at chs) and david edgington (director, centre for japanese research, and associate professor in the department of geography) have generously contributed many expert insights on development planning issues in china, southeast asia, and japan. i am very grateful indeed for the administrative support of ms karen zeller, and the unfailingly professional and patient assistance of ms sharon kong in the preparation of this manuscript; for the high levels of technical assistance provided by ms christine evans; and for the excellent cartographic services of mr eric leinberger of the ubc department of geography. key: cord- -kqvh w authors: hentschel, raoul; strahringer, susanne title: a broker-based framework for the recommendation of cloud services: a research proposal date: - - journal: responsible design, implementation and use of information and communication technology doi: . / - - - - _ sha: doc_id: cord_uid: kqvh w finding and comparing appropriate cloud services that best fit cloud service consumer requirements can be a complex, time-consuming and cost-intensive process, especially for small and medium-sized enterprises. since there is no “one-fits-all” cloud service provider, companies face the challenge of selecting and combining services from different vendors to meet all their requirements. therefore, this paper calls for the design of a cloud brokering framework that would enable faster and easier selection of cloud services by recommending appropriate services through a matchmaking system. drawing on previously conducted studies and considering current issues and practical experiences both from provider and user perspectives, we propose a framework that would identify, rank and recommend cloud services from multiple modules and components to individual consumers. furthermore, we contribute an early-stage design of a cloud broker framework that considers cloud-service consumers’ sourcing preferences while making new cloud-sourcing decisions and that can be used in the selection and adoption phase of implementing cloud services and/or as part of a multicloud strategy. cloud computing (cc) is a driving force in the current digitization debate that offers companies of all sizes new benefits such as consuming computing resources (e.g., networks, servers, storage, applications, and services) with low/minimal entry costs, pay-per-use options, great flexibility, and scalability. due to the recent proliferation of cc, the number of cloud services on the market is increasing rapidly. therefore, the selection and implementation of suitable cloud services is a challenging, knowledgeintensive process that requires widespread participation and ownership among heterogeneous stakeholder groups (e.g., business managers, it units, etc.) [ ] . the variety of available services is further complicated by a lack of informational transparency concerning product characteristics, technology, qos, pricing and their intercorrelations (e.g., price/quality trade-offs). this makes it difficult to compare cloud services and select the option that best fits the cloud service consumers' (csc) requirements. finding a suitable cloud service provider (csp) that matches all the csc's requirements is a complex, time-consuming and cost-intensive process that can prevent the adoption of cc especially in small and medium-sized enterprises (sme) [ ] . the reasons for this are manifold: a lack of universal definitions and standards for cloud services [ ] , the challenge of comparing the characteristics and performance metrics of cloud services over different maturity levels and quality standards, and different naming conventions for the same services, an understanding of which requires domain-specific knowledge of cscs [ , ] . as a result, cscs increasingly need guidance support systems [ ] that enable faster, easier and more reliable cloud services selection by helping smes choose (the best) services from a wealth of alternatives. we define these alternatives as service configuration options (sco). to the best of our knowledge, there is currently no approach available that specifically supports the (semi-)automated identification and recommendation of cloud service alternatives for smes using a cloud brokering and matchmaking system. in order to address this problem, we propose a cloud service broker framework called "vibros" as a starting point for supporting cscs in their decision-making process by recommending appropriate cloud services based on csc requirements using dynamic and extensible matching methods. thus, our research question (rq) is: how should a cloud-service brokering framework be designed to support cloud service consumers in smes in the selection and adoption phase of implementing cloud services? in order to answer this rq, the remainder of the paper is organized as follows: the introduction and definition of the problem included above (sect. ) are followed by the theoretical background (sect. ) and the proposal of a new framework (sect. ). the paper ends with the conclusion and future recommendations (sect. ). cc is an alternative approach to it sourcing that enables companies to access a shared pool of managed and scalable it resources (e.g., networks, servers, storage, applications, and services) that are accessible via the internet on a pay-per-use basis without necessitating long-term investments [ ] . cc services are typically classified by the type of service differentiated by a given resource (e.g., application (saas), platform (paas) and infrastructure (iaas) level) [ ] . in addition to the more technical characteristics, more business-oriented classifications have also emerged to differentiate these services from one another. böhm et al. [ ] identified eight common market actors that interact in a cloud value network. additionally, the nist defines five major actors: cloud consumer, cloud provider, cloud auditor, cloud broker, and cloud carrier where each entity (a person or organization) performs tasks in cc [ ] . a cloud broker (cb) is an entity who acts as an intermediary between the csp and the csc and performs tasks that involve the selection, integration, or delivery of cloud services. additionally, cbs also fulfill functions such as aggregating information concerning goods and fostering trust between cloud providers and cloud consumers [ ] . there are many examples of markets in which two or more groups interact via intermediaries or platforms to benefit each other and potentially create cross-platform network effects (e.g., airbnb, uber, etc.) [ , ] . all these so-called multi-sided platforms (msp) have one thing in common: they can only be successful when the "chicken-and-egg problem" can be solved by convincing both sides of the market to engage their services [ ] . matchmaking platforms, such as cloud brokering platforms, can also be seen as two-sided in the sense that the matching "platform" is more attractive when more participants on the other end of the market participate [ ] [ ] [ ] ; hence, a successful cb will be of value for both consumers and vendors [ ] . two of the main benefits of cbs from a consumer's point of view are its ability to minimize search time, thereby saving costs, and its providing an opportunity to interact with an expert instead of working with numerous csps [ ] . consumers also benefit from the support provided for activities such as the selection, implementation and management of cloud services and can thereby avoid being "locked-in" to a single provider. for csps, cooperation with a cb may enhance market visibility and result in a higher rate of revenue growth [ ] . the need for brokering mechanisms for cloud services first arises when using cloud federation architectures, such as intercloud [ ] or stratos [ ] . there are various concepts about and frameworks for cloud brokering that have been discussed in prior research [ ] , including those dealing with service intermediation between csps and cscs [ , ] . however, most of the literature focuses on building cloud brokerage systems where users either provide low-level specifications (e.g. resource requirements for applications or qos requirements for applications) that are measurable and comparable functional requirements [ ] or are limited to technical issues that can be solved using multiple-criteria decision-making (mcdm) methods [ ] . however, the literature does not consider organizational or environmental aspects. additionally, we were unable to find any approaches specific to the needs of smes [ ] . we argue that startups and smes need cloud brokering systems that are not only designed for large cloud implementation projects but are also better aligned with the nature of cloud services (e.g. flexible, automated) in terms of type and cost. also, the selection and integration of new services is a very dynamic process that will affect daily business operations. the goal of our research is to address the gap in the literature and, as a first step, to propose a framework that considers the functional and non-functional requirements of cloud consumers on the technical, organizational and environmental levels. this will enable smes to make a reasonable decision about csps, even without domain-specific knowledge, while achieving lower costs and saving time in comparison to traditional consultants and cloud brokers. second, we propose a prototype that enables a (semi-) automated selection of cloud services as part of a recommendation system. to do so, we follow a design science research (dsr) approach. dsr is an important paradigm in is research as it serves as a guideline for the process of constructing socio-technical artifacts in the is domain [ ] . we follow the process of peffers et al. [ ] for creating design science artifacts and then map these artifacts onto the digital innovation roles in dsr, as proposed by [ ] . in order to adequately consider current issues and practical experiences, the requirements of smes for such a framework were analyzed from both the provider and user perspectives in a previous work [ , ] . based on the findings of that piece and an extensive literature review on existing frameworks, we have iteratively developed the first version of our virtual broker as a service framework, called vibros, as part of our design-oriented approach (see fig. ). vibros discovers and ranks cloud services for cscs based on one or more decision components and filters the results to finally make a recommendation at the user's request. inputs are (feature) requirements and a textual description in natural language of the desired features of the cloud service. these provided inputs (requirements components) can then be prioritized and processed by a discovery service called vibros cloud matchmaker that uses the back-end decision components for the subsequent matchmaking. the decision components are defined by the platform owner and can be dynamically added and/or removed and are accessible via api (e.g., restful web services). each component can be addressed and enriched with information provided by csps. finally, the vibros cloud matchmaker generates options determined by users' preferences, makes a pairwise comparison of every sco using the ahp method, and recommends those that are suitable. it thus finds a match between the appropriate cloud services and the sme looking for one. since not every csc is willing or able to sign a contract with a csp immediately, the csc can also evaluate the cloud scos proposed by a neutral expert (i.e., consultants, integrators, etc.). thus, the expert has the option to support the consumer in steps that go beyond the selection of a csp (e.g. in the implementation of services) and thereby generates more business. as a result, the csc receives a bundle of suitable cloud services, ranked according to their specific suitability with the option of having them evaluated by an expert, before finally selecting one or more cloud services to implement. the current state of our research shows that many existing frameworks only provide partial guidance in the selection phase of cloud services. this research-in-progress article addresses this gap and proposes a new framework called vibros as a starting point for providing a more reliable and cost-efficient approach for smes to use while selecting appropriate cloud services. since there is no "one-fits-all" csp, cscs can benefit from receiving recommendations for cloud scos, which will therefore reduce search costs while taking sourcing preferences (e.g., requirements, priorities, etc.) into consideration in the selection and adoption phases. researchers can use key components of the framework to support their own cloud brokering problems. in future work, the back-end decision components and cloud matchmaker algorithms of the framework must be designed in more detail in order to instantiate a prototype of vibros. also, the handling of the heterogeneity of cloud services must be addressed in more detail. currently, the framework is not limited to a particular cc service type (saas, paas, iaas). however, an initial focus on one of these types in order to limit the number of scos could be beneficial for a first prototypical implementation. horizontal allocation of decision rights for on-premise applications and software-as-a-service a descriptive literature review and classification of cloud computing research cloud computing services: taxonomy and comparison cloud computing service metrics description a domain specific language and a pertinent business vocabulary for cloud service selection a review of the nature and effects of guidance design features the nist definition of cloud computing towards a generic value network for cloud computing nist cloud computing standards roadmap. special publication competition in two-sided markets let a thousand flowers bloom? an early look at large numbers of software app developers and patterns of innovation platform competition in two-sided markets the economics of two-sided markets chicken & egg: competition among intermediation service providers competing matchmaking motives for e-marketplace participation: differences and similarities between buyers and suppliers a strategic analysis of electronic marketplaces some empirical aspects of multi-sided platform industries algorithms and architectures for parallel processing introducing stratos: a cloud broker service intercloud architecture framework for heterogeneous cloud based infrastructure services provisioning on-demand towards secure cloud bursting, brokerage and aggregation qbrokage: a genetic approach for qos cloud brokering multiple criteria decision making critical success factors for the implementation and adoption of cloud services in smes positioning and presenting design science research for maximum impact a design science research methodology for information systems research roles of digital innovation in design science research current cloud challenges in germany: the perspective of cloud service providers key: cord- - e z p authors: li, kui-wai title: the economic strategy for the hong kong sar: evidence from productivity and cost analysis date: - - journal: journal of asian economics doi: . /j.asieco. . . sha: doc_id: cord_uid: e z p abstract by using a growth accounting framework for the period – , this paper estimates hong kong's total factor productivity and unit labor cost of twenty industries classified into three economic sectors of tradable goods, tradable services and non-tradable services. the results show that hong kong's total factor productivity has fallen in the s. the competitiveness of the three sectors of tradable goods, tradable services and non-tradable services has increased, remained unchanged and declined, respectively in the last two decades. policy recommendation for hong kong will be to aim for a supply-drive strategy so as to broaden the economic base. after becoming a british colony in , hong kong became an important trading and re-export hub. over the years, hong kong had acted as a ''shelter'' receiving a large number of natives fleeing from mainland china in pursuit of political stability and economic opportunities. hong kong's economic openness and desire to attain economic security enabled hong kong to supply goods and services to the rest of the world. the rise in income and demand was the result of the successful outcome of the supply-driven economic strategy. on july , , hong kong became the special administrative region (sar) of the people's republic of china. the central people's government in beijing adopted the ''one country, two systems'' approach in the post- hong kong. since , hong kong experienced economic revival and wealth appreciation, but the rapid growth was soon fuelled with speculation in stocks and properties in the early s, resulting in the economic bubble that eventually burst after the outbreak of the asian financial crisis (afc) in - . the economic problem facing the post-afc hong kong economy was structural imbalances with unemployment rate exceeding % in . such short-term fiscal incentives as the creation of temporary employments and assistance to small-and medium-sized industries have been introduced. after the outbreak of the severe acute respiratory syndrome (sars) in the spring of , additional demand-driven solutions aimed to revive the hong kong economy, including the entry of visa-free mainland travelers and the conclusion of two closer economic partnership agreements in and that permitted tariff-free exports of goods and services to mainland were introduced. economic optimism resulting from demand-driven policies has picked up and it is expected that when the new disney theme park opens in september , the hong kong economy would have recovered considerably. table shows that hong kong's macro-economy generally performed better in s than in s, and the first half of s was better than the second half of s. strong reexports growth lasted till the first half of the s, and export of services maintained high. growth in domestic investment remained robust in the - decade. the average real gdp growth maintained at . % in the s and . % in the s. beginning from the early s, despite the large total export to gdp ratio, domestic export could not keep pace with its growth rate. post-afc economic solutions advocated by the free-market school (enright, scott, & dodwell, ; wong & tao, ; imai, ) supported demand-driven policies and argued that the hong kong economy can recover along with the rest of the world as the linked exchange rate shielded hong kong from price differentials. on the contrary, structural or supply-driven advocates (dodsworth & mihaljek, ) noted the structural imbalance and believed that hong kong's economic advantage can further be eroded as economic situation in southern china strengthened. this paper expanded the data used in imai ( ) and followed the classification of economic sectors used in wong and tao ( ) , and extended the empirical analysis by comparing total factor productivity (tfp) with unlit labor cost analysis. the empirical analysis show strongly that structural rigidity rests largely on the non-tradable service sector. for hong kong to achieve economic revival, economic recovery is the first step, but resources reallocations to the more competitive tradable industry and service sectors will strengthen hong kong's advantage and expand hong kong's economic base and capacity. the results clearly show the vulnerability and insufficiency of the demand-drive school, and demonstrate that it would be the successful application of supply-driven policies that could lead the hong kong economy to a new stage of achievement. by using economic data from the two decades of - , this paper first uses the national accounting approach to work out hong kong's economy-wide tfp. the economywide capital stock will then be disaggregated to examine the tfp of major economic sectors (tradable goods, tradable services and non-tradable services). section discusses the debate in relation to hong kong's economic recovery. section uses the national accounting framework to work out the economy-wide tfp. sections and examine the tfp and unit labor cost of the three economic sectors, respectively. section suggests policy recommendations and concludes the paper. the description and construction of data are shown in the appendix a. there are four related arguments in the demand-driven school (imai, ; enright et al., ; wong & tao, ) . adherence to the advantages of the free market laissezfaire system has enabled the hong kong economy to recover along with the rest of the world according to the cyclical movements. the demand-driven nature of the hong kong economy resulted from the experience of the s and s when hong kong simply drifted along with or responded to the world demand of light manufacturing exports. since the s, demand has shifted to producer services. secondly, the linked exchange rate system adopted since can shield hong kong from loss in competitiveness because price differentials will eventually be adjusted through the current account. the linked exchange rate system can automatically adjust the hong kong dollar prices of tradable goods and services. thus, hong kong's tradable sectors remained price competitive despite wage increases. the rise in price of non-tradable sector is simply the result of expansion in the tradable sector, and a strong domestic demand is reflected in the increase in the value-added content of the non-tradable sector. thirdly, hong kong's advantage lies in its ability to provide business clusters that keep hong kong competitive despite the low production cost in southern china. cost of production becomes secondary if business opportunities are good and profits are made. the international, open and free nature of hong kong is itself a powerful competitive edge that few economies in the neighboring economies possess. the classification of services shall not exclusively be considered as consumption good. since the work of one producer can improve or add value to the work of another producer, goods and services have usage in both consumption and production. it is true that with the reallocation of hong kong manufacturing plants to southern china, hong kong firms have become service firms and provide services to the manufacturing sector. economic reform in mainland china has speeded up hong kong's transformation to a manufacture-related service centre. thus, while hong kong loses her comparative advantage in manufacturing, hong kong has gained new advantage in producer services. producer services contain the output of those industries producing intermediate inputs (for example, business services, wholesale) and some fraction of those industries that are consumer-based (for example, restaurants, hotels and transportation). the estimates in wong and tao ( , tables . - . ) show that producer services is the largest sector and experienced the largest annual average growth rates. for example, the share of the four producer services (business services; transport, storage, and communications; import and export; and finance) accounted for % of producer services in (wong & tao, , p. ) . in terms of average annual growth rates in - , producer services experienced a largest increase of . %, followed by government services of . %, consumer services of . % and manufacturing of À . %. wong and tao ( , p. ) concluded that hong kong has transformed from an ''enclave'' economy into a ''metropolitan'' economy. the supply-driven school (dodsworth & mihaljek, ) acknowledged the fundamental importance of the free market mechanism, but noted the structural imbalance and believed that the high cost can erode hong kong's economic competitiveness, which is defined as ''the degree to which domestic products and services can be marketed profitability.'' hong kong's robust economic performance since the conclusion of the sino-british negotiation in has led to wealth appreciation and income expansion, but the emergence of short-term investment behavior since the mid- s concentrated mainly in speculative activities in stocks and real estates. by the mid- s, the hong kong economy was speculation-led, characterized by a falling level of domestic exports and rising cost. statistics on wage increase showed that in the period - , tradable goods have twice experienced a two-digit wage increase in both current and constant price terms, while such non-tradable services as electricity and gas, transportation, and storage and communication, have experienced a total of four or five occasions of two-digit wage increase in both current and constant price terms (li, ) . hong kong's economic structural rigidity is the result of two separate economic trends (li, ) . on the one hand, sharp expansion in speculative activities boosted the nominal economy that merely involved monetary transactions. on the other hand, industrial hollowing and the fall in domestic exports resulted in the shrinkage of real economic activities that involved a reduction in employment, industrial output and exports. when the economic bubble burst, the structural imbalance was exposed when the shrinking real economy could not support the collapse of the nominal economy. differentiating the cobb-douglas production function that specified a relationship between aggregate output (y) and the three factors of capital stock (k), quantity of labor (l) and level of technology (a) with respect to time and dividing the result by y, a production function can be constructed as follows: ( ) where f k and f l are the factor marginal products and g represents technological progress or an estimate of tfp, commonly known as the solow residual. let s k = (f k k)/y and s l = (f l l)/y represent the shares of capital and labor factor payment in total output, respectively. a constant return to scale means that s k + s l = . the value of tfp can thus be calculated from eq. ( ) if all the other variables are known. the capital stock figures are estimated from the following equation: where rni is real net investment, which is real gross investment less depreciation. hong kong's aggregate output can be measured by the production-based real gdp. the gdp deflators are used in deriving the real figures expressed in constant prices. the capital stock figures are constructed from the accumulation of gross investment. real gross investment consisted of the gross fixed capital formation in the private sector, which included non-residential building, other construction, real estate developer's margin and all machinery and equipment, and change in stocks, expressed in constant prices. a depreciation rate of % is assumed, and the initial capital stock (in which is the earliest year when the gross fixed capital formation figures are available) is set equal to five times the value of the gross fixed capital formation (kim & lau, , appendix a). the labor input is measured by the number of working hours (h). employment in each time period is simply the size of the registered labor force (l) less the unemployed. the total number of labor hours is total employment multiplied by the average number of working hours per time period (see appendix a). the labor variable can be constructed from eq. ( ) with u indicating the unemployment rate. the data on the compensation of employees are adjusted to include the self-employed. one assumption is that the share of self-employed in the number of people engaged is the same in all industries. dividing the adjusted compensation of employee by the total valueadded in each industry gives the share of labor income. by deducting from unity the labor share in total factor payment gives the capital share in total factor payment. the constructed data (see appendix table a . ) shows that between and , production-based real gdp increased by %, while capital stock and labor increased by . and . %, respectively. table summarizes the total factor productivity estimates for the period - . output, capital and labor have grown by . , . and . %, respectively. output has experienced the highest growth in the - periods, with an average annual growth rate of %. capital experienced a higher growth rate in the s than the s, and the first half of the two decades showed a better performance ( . and . %, respectively) than the latter half ( . and . %, respectively). although the growth of labor is similar in the two decades, the growth rates in the - and - periods exceeded %. the shares of factor payment between labor and capital remained constant over the years. total factor productivity (tfp) shows an average of . % in the entire - decades, but its performance was higher in the period - (with . %) than other periods. in the overall and sub-periods, the contribution of capital to output is higher than labor. hong kong experienced high productivity growth in the second half of the s, but it has fallen considerably since the early s. despite a fall in the tfp in the two subperiods of - and - , contribution by capital ( . % as compared to . %) and labor ( . % as compared to . %) were similar. hong kong experienced a worse productivity rate (À . ) in the period - that covered the afc than the - period (À . ) during the sino-british negotiation. by contrast, labor's contribution increased to . % in the - periods, suggesting that labor productivity increased when unemployment increased and cost fell. the twenty industries in hong kong are classified under eight major categories by the government. the tfp of manufacturing improved strongly in the first half of the s, while the performance of most services deteriorated in the s, especially after the afc. these twenty industries can be classified into three economic sectors of tradable goods, tradable services and non-tradable services as follows: tradable goods sector: manufacturing; mining and quarrying. tradable services sector: import/export trade; hotel; storage; financing (banking + finance and investment companies + stock, commodity and bullion brokers, exchanges and services + financial institutions); insurance; business services (rental of machinery and equipment + business service other than rental of machinery and equipment); land transport (land passenger transport + supporting services to land transport + land freight); water transport (ocean and coastal water transport + inland water transport + supporting services to water transport); air transport; and other transport services. non-tradable sector: construction; electricity, gas and water; wholesale; retail; restaurants; communication; real estate; and community, social and personal services. the output of tradable goods sector reached its peak in with a share of . %, but by the late s it fell to around % (see appendix table a . ). output of tradable services sector has expanded most in real terms as its percentage share has doubled in the two decades (from . % in to . % in ) , and since it has exceeded the percentage share of non-tradable services that declined from % in to about % in . the tfp of the three economic sectors is shown in table . the tradable goods sector, which is largely dominated by manufacturing, enjoyed a positive tfp growth rate in all periods, giving an average of % in the - period with a higher rate in the s ( . %) than the s ( . %). the tradable services sector has a lower tfp growth rate, but remained positive except in the period - , giving an average of . % in the two decades of - . contrary to the tradable goods sector, the tfp growth rate for the tradable services sector is higher in the s ( . %) than the s ( . %), suggesting the sum of the last three columns should equal to the first column; any difference is the result of rounding off. that tradable services expanded mostly in the s. the performance of the non-tradable services sector showed a negative tfp growth rate in most periods and a negative average (À . %) in the whole - periods. and in the afc period of - , the positive tfp growth rate of . % could have produced by a fall in the growth rates of both capital and labor. the demand-driven advocates (wong & tao, , appendix a) emphasized the rapid expansion of producer service industries, but noted the difficulty in deciding on the choice of producer services. both the definition and the estimation of the proportion of producer services are subject to debate. producer service is defined by subtracting the nominal values of consumer services and government services from the nominal value-added of total services. the percentage calculations are based on rough estimations, but are highly questionable (as reproduced in appendix table a . ). for example, all hotel services are regarded as producer services, but hotels accommodation is demanded by tours to hong kong that are consumer related. in the case of storage facilities, an assumption of % consumed as producer service suggested that the rest of % would be used for consumption purpose by private individual households. the estimates based on the division between tradable producer services and nontradable producer services as conducted in wong and tao's ( ) can be repeated by using the data and the calculations from table . table shows the tfp growth rates of tradable producer services and non-tradable producer services using the percentage shares between the consumer and producer components in each of the service industry given in appendix table a . . real output growth shown in the first column is much higher in the tradable producer services ( . %) than the non-tradable producer services ( . %). capital stock grew much faster in the tradable producer services ( . %) than the non-tradable producer services ( . %). the tfp calculations also differed considerably. other than the period the sum of the last three columns should equal to the first column; any difference is the result of rounding off. - , the total factor productivity growth rates of tradable producer services were positive in all other periods, giving an overall of . % for the sample period. in the case of non-tradable producer services, other than a large percent growth of % in - , tfp fell in the decade of - . the entire s showed a score of . %, followed by a score of À . % in the s, giving an overall average of . % for the entire sample period. the tfp growth rates increased rapidly in - when both the growth rates of capital (À . %) and labor (À . %) fell, suggesting that a drop in factor inputs could lead to a rise in productivity. these estimates show that even with the use of wong and tao's ( ) classification, the tradable producer services were more competitive than the non-tradable producer services. labor productivity is indicated by the ratio of real output and the number of persons engaged, while the unit labor cost is the ratio of the payroll per person and labor productivity. labor productivity in the tradable goods sector, which is shown in fig. , has been rising since , while unit labor cost maintained a stable trend until the late s. as hong kong's manufacturing industries have migrated to southern china beginning from the mid- s, demand for industrial workers in hong kong has fallen, and only those efficient and productive workers can remain in the industry. the stable unit cost trend shows that the increase in output came mainly from productivity. thus, the improvement in labor productivity has maintained hong kong's competitiveness in the manufacturing sector. fig. gives a mixed picture for the tradable services sector. labor productivity has shown an overall rising trend, but unit labor cost has also caught up significantly and remained high until the late s. tradable services probably faced a competitive world price, and the economic overheating in the first half of the s has pushed up the unit labor cost. the fall in demand and price in tradable services after the afc, however, could have led to a considerable fall in unit labor cost. the picture shown in fig. on the non-tradable services sector suggests that while the labor productivity trend in the entire period showed only a one possible explanation on the high unit labor cost and low labor productivity in the non-tradable services sector could be their monopolistic position that shielded them from international price competition. the price and cost movements of non-tradable services tended to be rigid downwards, and that their monopolistic nature enabled them to increase price faster during the boom time, but was reluctant to let price to fall in a recession time. in the tradable goods sector, manufacturing definitely showed an improvement in labor productivity, as the number of workers has fallen and unit labor cost has fallen since the early s. in the tradable services sector, labor productivity has risen in import/export trade, hotel, storage, financing and water transport. the tradable services industries that showed a trend of rising unit labor cost included business services, land transport, and air transport. the industries that showed a mixed trend included insurance and other transport services. in the non-tradable services sector, those industries that showed a clear trend of rising unit labor cost include real estate, community, social and personal services, restaurant and retail. in construction, labor productivity showed a declining trend, while unit labor cost showed a rising trend. in electricity, gas and water, labor productivity rose significantly after . the result of these two industries may not reflect the true picture, as there is deficiency in the data on the number of persons engaged. communication and wholesale are the two industries that showed a rising trend in both labor productivity and unit labor cost. in wholesale, unit labor cost has a higher overall trend. the geometric average performance of unit labor cost growth rates in the second half of the s ( ) ( ) ( ) ( ) ( ) ( ) for the sectors and individual industries are summarized in table . given the outbreak of the afc in - , one would expect to see a fall in the unit cost in the second half of s. in the non-tradable services sector, the geometric average still showed an increase in unit labor cost by an average of . %, while both tradable services sector and tradable goods sector experienced an average fall of . and . %, respectively. price in the non-tradable services sector was rigid downwards, while the fall in the unit labor cost of tradable goods and services were in line with the movement of international prices. while the hong kong is linked to the us currency, the devaluation of major regional currencies had meant that the price of hong kong imports has fallen, and that would lead to a fall in price and deflation. with the exception of mining and quarrying that occupied only a small portion of gdp, individual industries that showed a positive geometric percentage growth in unit labor cost belong mainly to the non-tradable services (construction; community, social and personal services; real estate; restaurant and wholesale) and some tradable services (insurance; land transport; other transport services; business services and financing). those industries that experienced a fall in the unit labor cost are mainly the tradable goods and tradable service industries. among the twenty individual industries, eleven of them showed an increase in the geometric average unit labor cost, and the average percentage increase is . %. the large increase in construction pushed up this percentage. by contrast, the average of the nine industries with decreases in unit labor cost is À . %. the large percentage change can be due to the initial low wage paid to workers. in construction where sub-contracting is common, for example, a considerable amount of the cost would have taken up by the middlemen, while the actual wage paid to the construction workers is low. figs. and show the labor productivity and unit labor cost calculation using wong and tao's ( ) definition of tradable producer services and non-tradable producer services. in fig. , both labor productivity and unit labor cost have risen. although labor productivity leveled off in the late s, it kept rising until . on the contrary, the unit labor cost has risen rapidly in the late s but has declined since . in fig. , labor productivity has remained static with only small improvements since and a downward readjustment in . the unit labor cost of non-tradable producer services kept increasing in the entire period, except a small v-shape recovery during the afc. the rise in unit labor cost was not matched by a rise in labor productivity, suggesting that this sector was losing its cost competitiveness. by using a standard cobb-douglas production function for the two decades of - , this paper shows that hong kong's tfp has declined since the early s, and has reached negative growth rates in the second half of the s. hong kong has experienced an undisturbed period of robust economic growth until the outbreak of the afc in / . the estimates on the labor productivity of twenty individual industries show that the non-tradable services have performed poorly, and their unit labor cost has expanded. one can conclude that the solution to hong kong's economic problem rests on the unit labor cost and the uncompetitive nature of many non-tradable services. in the case of manufacturing industries, the high productivity suggested that new investments in hong kong's manufacturing sector could take place, though hong kong will not only confine to labor-intensive industries anymore. given the increasing role of the service economy, the expansion of the tradable services, including the tradable producer services, will be most suitable for hong kong, as it development can raise domestic demand and employment in line with international competitiveness. although the economic downturn results in rising unemployment, unit labor cost has revised downwards through market forces. despite the short-term economic sacrifice, productivity in hong kong can be improved in line with wage revision and new demands, both locally and internationally. hong kong needs to explore new economic channels, in addition to the various existing comparative advantages. this paper raises new questions on the relevance of sector composition in hong kong industries. the debate between demand-driven and supply-driven policies can complement each other. a flexible economic structure facilitates the function of the free market. the flexible economic structure means that hong kong should pursue supply-side strategies, as the availability of additional resources can attract further demand. in policy terms, this requires the continued investment in infrastructure, investment in human capital and the provision of more resources, typically land resources that can promote the economic capacity of hong kong. a long-term strategy that projects a multi-dimension economy is more suitable than to use short-term policies to reduce temporary economic ills, and repetition in the use of short-term policies could deprive the benefits of a long-term policy. hong kong cannot be a national economy, but a diversified economic base permits productivity to improve both extensively and intensively. international economics of the city university of hong kong is gratefully acknowledged. the author is responsible for all remaining errors. the hong kong data used in this paper can be found in the author's own website at: http://fbstaff.cityu.edu.hk/efkwli/data.html. the gdp deflators are obtained from on the average hours per employee worked in the last working week of the time period are available in the labor statistics (international labor organization, various years). these figures are then multiplied by a total of . weeks ( / days) to obtain the average number of hours worked per employee per year. for the period - , the statistics on the median hours per employee worked in the last working week of each time period are available and obtained from the census and statistics department. a similar formula is applied to derive the annual statistics, and the median hours are assumed to equal to the average hours. the value-added figures of each economic sector are used in calculating the labor factor share. each economic sector's value-added is given by the compensation of employees and gross operating surplus. the former is mainly wage payment to workers, while the latter is the return to employers and entrepreneurs including self-employed workers. in order not to understate the share to labor factor payment, the compensation of the self-employed should be included in the compensation of employees. this is done by calculating the adjusted compensation of employees, which includes the original level of compensation of employees and the portion of compensation derived from the self-employed. the statistics on the number of self-employed for the period - can be obtained from the annual digest of statistics (census and statistics department, various years), and the figures before were extrapolated. the analysis assumes that the compensation of the selfemployed is the same as the employed. the share of labor factor payment is calculated from the rate of adjusted compensation of employees to the production-based gdp in current price. the composite deflator of domestic exports is used as the deflator for the tradable goods sector, while the composite deflator of exports of services is used for the tradable services sector. the deflator for the non-tradable services sector is the geometric difference of the gdp deflator and the tradable sector's deflator shown in gross domestic product (table , pp. - ) . the industry-specific implicit price deflator is the ratio of value index and industrial production index or volume index. manufacturing and mining and quarrying are the only two industries that used the industrial production index data. most service industries used the volume index data. there are some exceptions. in electricity, gas and water, data on the consumption of electricity and gas (ceic database) and the consumption index are used to replace the industrial production index. in the import/export trade, the proxy deflator is the weighted average of the deflators for domestic exports, retained imports, and exports and imports of trade-related services. the transportation sub-index in the hong kong composite consumer price index (cpi) is used as the proxy for the deflator for land transport. this covers fares for ferries, trains, taxis and public transport, motor licenses and insurance, parking fees and tunnel tolls. in the case of water transport, air transport and other transportation services, the proxy deflator is the weighted average of the deflators for exports and imports of transportation services. the weights used are their nominal shares in the exports and imports of transportation services. the deflator for storage is derived from the rental index for private flatted factories. the telephone service in the miscellaneous service index of the composite cpi is used as the proxy deflator for communication. the weighted average of the deflators for export and import of financial services and the deflators for export and import of insurance services are used as proxy deflators for financing and insurance, respectively. the implicit price deflator for real estate developers' margin is used as the proxy deflator for real estate. the implicit price deflator for the exports of other services is used as the proxy deflator for business services. for community, personal and social services, the proxy deflator is the miscellaneous services sub-index of the composite cpi. this covers school fees and education charges, medical services, entertainment expenses, household services, hairdressing, repairs of personal and household goods, subscriptions, and postal and telephone services. the proxy deflator for wholesale is the implicit price deflator of retained imports. the census and statistics department provides the estimate for the value of retained imports and its quantum index for the period - (hong kong monthly digest of statistics, december , pp. fa ). the difference in the value of imports and reexports gives the value of retained imports, and the value at current price can easily be transformed into value at price. the retained import value for the period - , however, is estimated from extrapolating the - data. the implicit price deflator is calculated from the values of retained imports at current price and at price. the industries that had experienced a rapid rise in inflation in the s include community, social and personal services, electricity, gas and water, land transport, restaurants, construction and real estate. all these industries belong to the non-tradable sector where competition is limited. labor productivity is the ratio of real output and the number of persons engaged, and a labor productivity index with as the base year is calculated (table a. ). the unit labor cost index with as the base year is the ratio of nominal payroll index per person engaged and the labor productivity index. the nominal payroll per person engaged equals to total value of payroll at current market price divided by total number of persons engaged. statistics on the production-based gdp at current market price ( gdp, tables - , pp. - ) are used to represent nominal output. the number of persons engaged (including individual proprietors and active partners) is end-of-year figures from the principle statistics shown in the annual digest of statistics. there are two exceptions. for electricity, gas and water, the number of persons engaged for water is not available; the figures used in the analysis contain the number of persons engaged in electricity and gas only. the number of persons engaged in construction is the number of persons engaged in construction sites only. since the reported number of persons engaged would be smaller than the actual number, the labor productivity so calculated could be biased upwards. nominal payroll statistics found in quarterly report of employment, vacancies and payroll statistics are used because they include wages and other related cash payments, namely, wages, overtime pay, shift allowance, attendance and efficiency bonuses, cost-of-living or dearness allowance, food and transportation allowances, year-end seasonal bonuses and payment in lieu of leave, and so on. the quarterly report of employment, vacancies and payroll statistics gives the nominal payroll index per person engaged in four different base years (june , march , march , and march , which are then converted into one standardized series with as the base year for all industries. in cases where industries are being grouped together, namely land transport, water transport, financing and business services, the overall nominal payroll index per person engaged is the weighted average of the indices of its constituents. the weights are the number of persons engaged in the constituents (table a. ). ( ), appendix a, p. - . gross domestic product, annual digest of statistics, various issues and quarterly report of employment, vacancies and payroll statistics, various issues, census and statistics department hong kong, china: growth structuralchang, and economic stability during the transition. occasional paper the hong kong advantage structural transformation and economic growth in hong kong: another look at young's hong kong thesis the sources of economic growth of the east asian newly industrialized countries the political economy of the pre-and post- hong kong capitalist development and economism in east asia: the rise of hong kong trade and development report an economic study of hong kong'sproducer service sector and its role in supporting manufacturing the author is indebted to the referees, manoranjan dutta, francis lui and hiroyuki imai for their comments on the earlier draft, participants in the hong kong economic association biannual conference in december and eric kwok for his research assistance. funding support from the apec study center and the research center for key: cord- -vclij ax authors: glancy, d.; reilly, l.; cobbe, c.; glynn, m.; punchoo, s.; foy, k. title: lockdown in a specialised rehabilitation unit: the best of times date: - - journal: irish journal of psychological medicine doi: . /ipm. . sha: doc_id: cord_uid: vclij ax specialised rehabilitation units offer inpatient multi-disciplinary rehabilitation for individuals with severe and enduring mental illness. a cornerstone of therapy is the work in the community through further education and community organisations. however, coronavirus restrictions have meant that such external supports are no longer available for the duration of the crisis. this has led to opportunities for developing new ways of offering rehabilitation within hospital environments. this article describes some of the new initiatives developed. the benefits of the lockdown for service users are also discussed. many found the cessation of visits from family members with whom they had an ambivalent relationship helpful. the lockdown improved relationships between patients on the unit and encouraged a greater feeling of community. the lockdown has also emphasised the importance of team self-awareness and an awareness of the nature of the treatments offered. the national mental health division established placements at specialised rehabilitation units for individuals with severe chronic and enduring mental health illnesses at bloomfield hospital, dublin (hse mental health services, ) . the patients referred to the unit typically have a history of complex treatment refractory psychiatric symptoms and multiple prolonged admissions to acute mental health units. they have reduced ability to manage in the community despite intensive management from their local community mental health teams. the service was only established in and since then has accepted referrals from all parts of the country. whilst the majority of the service users have a diagnosis of schizophrenia, all have additional mental health needs and most have a history of complex trauma. our multidisciplinary team consists of specialists from psychiatry, psychology, occupational therapy, nursing as well as a peer support worker. the rehabilitation offered is individualised, goal orientated and led by service user-generated goals. prior to the national coronavirus- emergency, a fundamental pillar of the rehabilitation offered was an emphasis on activities in the community and outside the unit. as a result, our clients attended a variety of local services including adult education, men's sheds group, tidy towns groups, voluntary work in charity shops and fitness activities in local sport and leisure facilities. the lockdown restrictions meant that such local supports and activities were no longer available. the multidisiplinary team (mdt) in conjunction with service users therefore had to develop additional activities to support the rehabilitative programme. previously, most patients on the unit had weekly visits from family members. these visits were generally perceived to be helpful, and many of the patients had close relationships with their relatives. as family contact was curtailed due to the lockdown, many service users felt better able to reflect and empowered to speak with therapists about the nature of those relationships. familial constellation and the role of the patient within that system became much more apparent. patients opened up more during psychotherapeutic sessions about significant trauma or attachment issues. trauma and attachment issues within families can contribute to high levels of unhealthy enmeshment creating chaotic boundaries, difficulties with emotional regulation and poor sense of self for the individuals. one of the service users summarised the new world of the lockdown as 'no visits, no callspeace and space'. whilst families may be supportive, the family can also be the source of trauma triggers for those with complex trauma history. as stated by aldersey & whitley ( ) , 'families both facilitate and impede recovery process'. the lockdown created an opportunity to explore these challenges in a safe and non-threatening environment during : sessions and group sessions. the reduced visits from relatives meant that patients felt better able to examine patterns of communication, relationships, power structures and other aspects of family systems. many of the service users are highly self-critical, perfectionistic and have experienced considerable rejection and perceived failure throughout their time in psychiatric services. one of our patient summarised this as 'my doctor said that there was nothing he could do for me : : : i'm not like the others'. in essence, they have been through a revolving door with multiple relapses and readmissions. during the covid- pandemic, they described their setting as 'safe' and that 'everyone is in the same boat'. they reported feeling less expectations being placed on them, both by themselves and others. the team noted that it was easier to collaboratively work on development of grounding techniques, addressing internal critic, practising mindfulness, exploring past trauma and integrating self, improving self-care and improving awareness of emotions. prior to the restrictions, self-reflection could be easily avoided through engagement in a myriad of distraction and avoidance techniques. getting in touch with internal processes to integrate mind and body awareness has been an enriching though difficult journey for patients. for most, self-awareness improved, and there was increased hope for the future by addressing the past with one of our clients saying 'i am fearful but hopeful that i will see the light at the end of the tunnel'. during the lockdown, some reflected on their rehabilitation journey and one stated 'i can't believe i was allowed out on my own, and now i appreciate it even more, i will make full use of it in the future'. according to herman ( ) , 'safety, remembering, mourning and reconnection are essential trauma resolution preambles' which summarise the self-reflection for many during the lockdown. with the onset of covid- , previous routines have been thrown into chaos. the service has now adapted the therapeutic programme to enable this period to be a learning experience of self-discovery and examine our values, beliefs and raison d'etre. the focus has shifted to increasing group-based activities on the ward and looking at innovative ways to occupy this time based on service user needs. the team has committed to provision of traumafocused therapy and developed educational processes with staff psychology book clubs and lunchtime education groups. a tai chi group is delivered daily on the unit focusing on grounding, breathing and self-soothing (kong et al. ). the group is attended by everyone involved in the unit, staff and service users alike. a 'time to talk' group was established within the service to address social and relationship skills for service users with co-morbid learning disability or developmental disorders. the group was designed as an open forum to explore gender identity, expression and sexuality in the context of their own lives and society as a whole. a separate psychotherapy group was established for individuals with higher level functioning using the yalom model (yalom & lesczc, ) . the ethos of the wellness recovery action plan (wrap) (copeland, ) and the decider skills group (ayres & vivyan, ) fosters personal responsibility, developing coping skills and use of grounding techniques. the delivery of other existing group programmes has also undergone changes with the music therapist now delivering their sessions over the zoom application. an on-site greenhouse has afforded the opportunity for one service user to lead a gardening segment to fellow interested service users called 'how's it growing'. there are increasing tangible examples of shared camaraderie evident on the unit including service users sharing their cooked food and blossoming friendships among others. while some of these interactions have occurred spontaneously, the unit itself has focused on creating a therapeutic community with organisation of activities such as afternoon tea and outdoor hikes within the km distance. like the rest of the country, time was spent to enhance the physical environment by improving the garden and outdoor spaces with planting. the focus of this was to generate a common purpose and ownership of the shared space through engagement in meaningful pursuits. however, within any confined space, it is anticipated that conflict will occur, and healthy outbursts have been welcomed as individuals are encouraged to share how they openly feel about situations and resolve it accordingly. at the weekly peer support group, residents were offered the opportunity to express their thoughts and feelings about the restrictions in place as a result of the coronavirus outbreak. despite the increased focus on group and : sessions, maintaining social contact with the outside world has remained pivotal. service users were offered the same rights as everyone else to access the community in line with the national lockdown regulations. service users can access essential services within the community such as post office, bank and essential shops. a preventative approach to covid- was adopted with emphasis placed on hand hygiene and social distancing measures and adapted education sessions for this were developed and delivered. wilcock ( ) discusses the theory of 'doing, being and becoming' as central components for achieving wellness and realising self-actualisation. as a service in its infancy, this period of lockdown has encapsulated a greater balance between the three aspects, moving from primarily doing to being and becoming. as the psychiatrist victor frankl ( ) once said, 'when we are no longer able to change a situation, we are challenged to change ourselves'. the team believes that the end of the lockdown shall present its own challenges. the possibility of reinstatement of contact with family members, returns to activities in the community and increased external distractions have the potential to be testing. as a service, we plan to devote a number of group therapy and individual sessions to reflect on the past number of months and the return to a state of normality. using questionnaires, we hope to assess the service users and staff attitudes to the changes made to the programme during the lockdown. the results of these questionnaires along with wider patient and staff discussions will inform how we integrate the lockdown programme into a post-lockdown world. the lockdown allowed the team the space and opportunity to self-reflect on the essence of what defines our work. it allowed both service users and staff the opportunity to reflect on the shared journey that we are taking together and the necessity for collaboration, honesty and open dialogue. whilst families can often be seen as an important resource for service users, we became more aware of the double-edged nature of family relationshipsparticularly in individuals who have traumatic, ambivalent or challenging relationships with their relatives. all too often, in healthcare, we tend to prioritise action at the expense of reflection. the covid- emergency allowed this service to challenge that and to instead focus on developing a true therapeutic community from within. family influence in recovery from severe mental illness the decider skills for self help: cbt and dbt skills to increase resilience, coping and confidence wellness recovery action plan bloomfield sru (unpublished) man's search for meaning: an introduction to logotherapy trauma and recovery guidelines for the management of national specialised rehabilitation unit placements treating depression with tai chi: state of the art and future perspectives reflections on doing, being and becoming theory and practice of group psychotherapy, th edn the authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committee on human experimentation with the helsinki declaration of , as revised in . the authors assert that ethical approval for publication of this manuscript. this research received no specific grant from any funding agency, commercial or not-for-profit sectors. none.ethical standards key: cord- -no mojz authors: gaddy, sarah; gallardo, ressa; mccluskey, shelley; moore, leanna; peuser, alex; rotert, rachel; stypulkoski, corinne; lagasse, a blythe title: covid- and music therapists’ employment, service delivery, perceived stress, and hope: a descriptive study date: - - journal: music ther perspect doi: . /mtp/miaa sha: doc_id: cord_uid: no mojz in early , the covid- pandemic was declared, which impacted music therapists in terms of employment, service delivery, and mental health. however, the extent of changes within the profession was unknown. the purpose of this study was to determine the impact of the pandemic on the employment, service delivery, stress, and hope of music therapy professionals in the united states. music therapists (n = , ) responded to a -item survey including questions related to employment and service delivery. the study also included the adult hope scale and the perceived stress scale- (pss- ). results indicated that many music therapists experienced changes in their positions, including a decrease in client contact hours and an increase in using alternative services, such as telehealth. changes in service hours and delivery were higher for individuals who worked in private practice than for other settings. primary respondent concerns included being a carrier of covid- , being isolated from loved ones, and income loss. compared with prior general population samples from the united states, respondents reported higher levels of hope, with a majority of respondents also reporting a high level of hope for the profession. respondents also indicated a moderate level of perceived stress on the pss- . open response comments provided additional insights into the situational stressors and feelings of hope at this time in the pandemic. the results of this study indicate that music therapists adapted to service delivery changes and continued to provide services to clients, despite the many difficulties faced during the pandemic. abstract: in early , the covid- pandemic was declared, which impacted music therapists in terms of employment, service delivery, and mental health. however, the extent of changes within the profession was unknown. the purpose of this study was to determine the impact of the pandemic on the employment, service delivery, stress, and hope of music therapy professionals in the united states. music therapists (n = , ) responded to a -item survey including questions related to employment and service delivery. the study also included the adult hope scale and the perceived stress scale- (pss- ). results indicated that many music therapists experienced changes in their positions, including a decrease in client contact hours and an increase in using alternative services, such as telehealth. changes in service hours and delivery were higher for individuals who worked in private practice than for other settings. primary respondent concerns included being a carrier of covid- , being isolated from loved ones, and income loss. compared with prior general population samples from the united states, respondents reported higher levels of hope, with a majority of respondents also reporting a high level of hope for the profession. respondents also indicated a moderate level of perceived stress on the pss- . open response comments provided additional insights into the situational stressors and feelings of hope at this time in the pandemic. the results of this study indicate that music therapists adapted to service delivery changes and continued to provide services to clients, despite the many difficulties faced during the pandemic. keywords: covid- pandemic, employment, hope, music therapy service delivery on march , , the covid- pandemic (henceforth referred to as the pandemic) was declared by the world health organization (who, ) . the covid- virus was originally detected in november and began to spread throughout the united states in early march . the spread of a novel virus leads to uncertainty due to the unpredictable nature of the virus and continual changing information about risk, mortality, and severity (harwood, ; morens & taubenberger, ) . researchers and mental health professionals recognized the potential for the pandemic to affect stress and mental health (mucci et al., ) , with researchers highlighting the negative impact of the pandemic on the mental health of healthcare professionals (moazzami et al., ) . as healthcare professionals, music therapists (mts) experienced personal and professional changes due to the pandemic; however, the extent of change within the united states was not yet established. one of the first responses to the pandemic in the united states was for state governments to implement social distancing, "stay at home," and/or quarantine protocols (mervosh et al., ) , in an effort to slow the spread of the pandemic and decrease the impact on healthcare facilities (centers for disease control and prevention [cdc] , ). these protocols had a drastic impact on the economy and employment, as the united states reached an unemployment rate of . % in april (long, ) . changes in employment were seen across many nonessential healthcare workers, as social distancing and quarantine protocols restricted the ability for these professionals to provide in-person services (e.g., department of health and human services, ). balanzá-martínez et al. ( ) highlighted how the combined impact of financial difficulties and social isolation could further impact mental health and the overall feelings of stress. social distancing and quarantine protocols created an immediate need for many professionals to shift away from in-person services to telehealth and other alternative services (cdc, ). on march , , the american music therapy association (amta, ) posted a statement indicating that mts were needing to make difficult decisions about in-person services, given the risk of viral spread during face-to-face contact. the shift to telehealth within the profession was documented on april , , with a statement from amta supporting telehealth as a beneficial means for providing services to clients. resources were added to the amta website, including a guide for virtual service delivery that provided suggestions for curating/creating virtual content and providing telehealth services (block & knott, ) . although these alternative services provided an opportunity for clients to continue receiving music therapy, professionals were required to quickly learn about online service delivery, including securing permissions and ensuring compliance with the health insurance portability and accountability act (hipaa). furthermore, the extent to which these services were employed by mts was still unknown. the rapid changes required in response to the pandemic, combined with uncertainty about the future of employment and/or service delivery, may have impacted the perception of stress and feelings of hope in music therapy professionals. according to folkman ( ) , decreased control over one's own circumstances can impact a person's feelings of hope, particularly in times of high psychological stress. furthermore, uncertainty can exist within stressful situations, and hope is one way to cope with uncertainty. according to snyder ( ) , hope is comprised of two concepts (ways of thinking): pathways and agency. pathways relate to an individual's ability to produce a plan to meet a goal, whereas the agency describes an individual's motivation to meet those goals by the determined pathways. individuals with high hope are more likely to generate alternative routes to goal attainment and be more adaptable when encountering obstacles (snyder, ) . measuring perceptions of hope and stress could provide the music therapy community with information on how music therapy professionals responded to circumstances surrounding their careers during the pandemic. the purpose of this project was to determine the impact of the pandemic on the employment, service delivery, hope, and stress of music therapy professionals. to this effect, the researchers asked the following research questions: ( ) what changes are music therapy professionals experiencing in terms of contracts/job hours? ( ) what changes are music therapy professionals experiencing in terms of income? ( ) what changes are music therapy professionals experiencing in types of services provided? ( ) what are the feelings of hope reported by music therapy professionals? and ( ) what is the level of stress reported by music therapy professionals? this study received ethical approval from the university institutional review board (irb - h). the survey was sent via email from the certification board for music therapists (cbmt) roster, which included , mts in the united states. the survey link was also posted on social media platforms such as facebook and linkedin. consent was obtained from , individuals, yielding a % response rate. five individuals working outside the united states and individuals who did not complete the demographics section were excluded from the results. the remaining , ( . %) survey respondents were included in the data analysis, of which , completed the entire survey. at the end of the survey, respondents had an option to enter their email for a chance to win a $ gift card and could elect to receive notification of follow-up surveys. individuals were provided with a list of resources in case they experienced stress. the full survey is available in appendix a of online supplementary material. the survey demographic and employment questions were created by the researchers, using kern and tague ( ) as a model. the survey was sent to two researchers with experience in descriptive research and piloted with mts prior to release. the survey was administered using qualtrics beginning on april , , and remained open for two weeks. the survey consisted of items within four sections: ( ) demographics, ( ) employment/services provided, ( ) levels of hope, and ( ) levels of stress. respondents were allowed to select all options that applied in sections pertaining to current situation, job position, and client populations, due to the multiple roles held by mts. participants were permitted to advance without answering all questions, and items that were not relevant to them were skipped. the survey included two standard scales: the adult hope scale and the perceived stress scale- (pss- ). adult hope scale. the adult hope scale is a standardized questionnaire that asks respondents to self-report degrees of agreement to statements on an -point likert scale (snyder, ) , with a range from (low hope) to (high hope). eight of the statements are broken down to two subscales representing participants' agency (items , , , and ) and pathways (items , , , and ), with each subscale ranging from (low hope) to (high hope). the additional four questions are filler items. agency and pathways scores are added to determine a total hope score, with higher scores reflecting higher levels of hope. snyder ( ) noted the mean total hope score for the general population was (sd = ). the instrument has shown high internal consistency, with alphas from . to . , across samples (snyder, ; snyder et al., ) . the researchers added an additional question to capture respondents' feelings of hope for the state of the profession. perceived stress scale. the pss- (cohen et al., ; cohen, ) was used to measure mts' perceptions of stress during the pandemic. the pss- asks the respondent about the stress in the previous month using questions about perceived feelings. individuals rate their frequency of each feeling on a -point likert scale from (never) to (very often). there are four positively worded questions that are reverse scored. scores on the pss- are compiled into a single score that ranges from (lowest perceived stress) to (highest perceived stress). the instrument has been shown as reliable, with relatively high internal consistency (ɑ > . ) across studies of different populations (lee, ) . in , the pss- was administered to , individuals in the united states, with an overall mean score of . (sd = . ) (cohen and williamson, ) . the pss- has been used in previous music therapy research with student participants (moore & wilhelm, ) . the online survey included quantitative and qualitative data in order to more comprehensively capture mts' experiences during the pandemic. the research team completed a descriptive analysis for multiple choice, ranked, and percentage answer questions. this included a tally (number of responses and percentage) for questions regarding changes in workload/assignments and providing different services. it should be noted that response counts for each individual question varied, as respondents could advance through the survey without answering all questions. there were two standard scales included in the study. for the adult hope scale, the researchers calculated the mean and standard deviations of the agency subscale, pathways subscale, and total score (summation of agency and pathways scores). the researcher-added question about hope in the music therapy profession was not included in the subscales or total score calculations. for the pss- , the researchers calculated the total score by reverse scoring the positively worded items and then adding the items for each participant. the researchers computed a cronbach's alpha value to determine internal consistency. levels between . and . are considered within an acceptable range (tavakol & dennick, ) . the researchers conducted pearson's correlations to examine the strength of the relationship between pss- scores and three scores related to the adult hope scale (agency subscale, pathways subscale, and the overall hope scores). the researchers also conducted a correlation to examine the relationship between the total adult hope scale score and the hope for the music therapy profession score. in this survey, there were two open-ended questions, one focused on feelings of hope for the profession and the other allowing respondents to comment regarding their experiences during the pandemic. similar to the procedures used in rushing et al. ( ) , two members of the research team independently read comments, developing a list of possible codes. the researchers then clustered these codes into themes and subthemes. the researchers completed these steps separately, and then discussed discrepancies to agree upon themes. each pair of researchers used excel to individually count the frequency of the themes and subthemes and reported these counts within the results. a total of , responses were received from mts working in the united states. respondent ages ranged from to , with nearly half the respondents representing the to age group ( . %). the majority ( . %) reported having a bachelor's degree as their highest level of education while . % reported having a master's degree. all regions of amta were represented. over half ( . %) of respondents reported working in the profession between and years (table i) . the first research question involved changes in contracts/ job hours during the pandemic. out of , respondents, ( . %) reported working full time, ( . %) reported working part-time, and ( . %) reported contracting for an agency or private practice prior to the pandemic (table i) . only . % of respondents reported being either unemployed or not currently working in the profession prior to the pandemic. when providing information about changes in employment (n = , ), ( . %) respondents reported no changes to their work duties. respondents reporting changes in employment (n = ) were most often providing remote clinical services from home ( . %). fewer respondents reported being assigned different duties to complete on-site ( . %) or from home ( . %). one hundred and forty ( . %) reported having their positions furloughed, and ( . %) reported having their positions eliminated. of the respondents who reported working at the time of this survey, provided information about their hours at this time in the pandemic (compared with , before the pandemic). sixty-one respondents ( . %) reported having ≥ client contact hours per week, compared with ( . %) prior to the pandemic. eighty-six ( . %) reported to client contact hours per week, in comparison to ( . %) prior to the pandemic. the greatest increase was seen in the category of to hours per week, with ( . %) compared with ( . %) before the pandemic. figure shows the change in contact hours by selected settings. the second research question explored income changes that mts have experienced as a result of the pandemic. when asked about their pay situation at the time of the survey, half of the , respondents indicated no changes in at least one source of income since the onset of the pandemic ( . %). some respondents indicated reduced compensation ( . %) or no compensation ( . %) as mts. one hundred and forty-six mts ( . %) reported using paid time off, public assistance/unemployment, or sick leave. of the respondents ( . %) who indicated "other (please describe)," nearly half of the write-in comments indicated reduced income. the most commonly mentioned reasons for this reduction included drastically reduced clinical hours, lack of virtual service availability, and lack of client/facility willingness to accept virtual services. various subgroups reported negative income changes more frequently than others. when analyzing reported income changes across clinical settings, private practice mts reported the lowest rates of stable income ( . %) and the highest rates of decreased ( . %) or eliminated ( . %) income. private practice owners seemed to be the most affected subgroup, with just under a third of this subgroup ( . %) reporting no mt-related income at the time of the survey. approximately, a third of mts in schools ( . %) and skilled nursing facilities ( . %) reported maintenance of full income, compared with over half of respondents working in universities ( . %), medical settings ( . %), and mental table i) . the third research question was focused on changes in types of services provided, with , respondents providing information about their pre-pandemic service provision and providing information during the pandemic. respondents who indicated no current clinical hours due to a furloughed or eliminated position were not asked about current service delivery. individual services accounted for a mean of . % of services provided (sd = . ) prior to the pandemic, compared with . % (sd = . ) at the time of survey. this corresponded with a decrease in group services from a mean of . % (sd = . ) of services provided to . % (sd = . ) at the time of survey. other services provided during the pandemic were offered . % (sd = . ) of the time, and open responses indicated that these services primarily included alternative services (such as prerecorded videos/material creation, staff support, and administrative tasks; online supplementary figure ) . of the respondents indicating current contact hours, a majority ( . %) reported that they were providing alternative services due to the pandemic. alternative services used often or very often included telehealth services ( . %), virtual music lessons ( . %), prerecorded songs/playlists ( . %), and prerecorded video sessions ( . %). figure shows the number of mts using alternative services often or very often within different settings. the shift of resources was also prevalent for alternative profession-related activities, with mts ( . %) reporting learning to use/researching telehealth often or very often during this time of the pandemic (see supplementary table ii for all professional activities). the adult hope scale had good internal consistency for the pathways subscale (ɑ = . ), the agency subscale (ɑ = . ), and the total scale (ɑ = . ). internal consistency remained high with the researcher-added question about hope for the music therapy profession (ɑ = . ). respondents' (n = , ) mean total hope score was . (sd = . ) during this time in the pandemic. this score is greater than the score published by snyder ( ) as a typical mean score (m = , sd = ). subscale scores for agency (m = . , sd = . ) were higher than pathways (m = . , sd = . ). when asked how they agreed with the statement "i feel hopeful about the music therapy profession," respondents most often indicated mostly true ( . %), definitely true ( . %), somewhat true ( . %), and slightly true ( . %). collectively, . % of respondents indicated agreement of feeling hopeful about the profession during the pandemic. mean hope scores and response to the question on hope about the music therapy profession were broken down according to respondents' reported employment status (supplementary figure ) . subgroups with lowest scores of hope for the profession included those experiencing furlough (m = . , sd = . ) or eliminated positions (m = . , sd = . ). there was a weak positive correlation (r = . , p < . ) between hope for the profession and total hope score. of the , respondents, ( . %) provided responses to the prompt "please comment on your feelings of hopefulness in the music therapy profession." a total of statements were included in the final analysis. ten major themes and representative statements identified from the analysis of the responses are displayed in table ii (and expanded supplementary table iii) . the most common theme was ongoing professional issues ( . %) that were unrelated to the pandemic. the next most common themes were: covid- as a source of growth for the profession ( . %), the adaptability and resilience of mts ( . %), and telehealth ( . %). of those who commented on telehealth, most respondents viewed telehealth as beneficial. a descriptive analysis of the -item pss- was completed for the respondents who answered all questions (n = , ). a cronbach's alpha showed that the pss- had good internal consistency (ɑ = . ). the mean scores for the respondents indicated that the mts perceived a moderate level of stress (m = . , sd = . ). individuals who had their position eliminated reported a slightly higher stress level (m = . , sd = . ) compared with the overall mean score. respondents who provided telehealth services (n = ; m = . , sd = . ) and who worked in different settings had perceived stress scores similar to the mean overall score (table iii) . results of correlational analyses between the pss- total scores and adult hope scale total scores indicated a significant negative correlation, with a weak relationship between higher hope scores and lower stress scores (n = , , r = −. , p < . ). a correlation between the two subscales and the pss- total score indicated a significant weak negative correlation for both pathways (r = −. , p < . ) and agency subscales (r = −. , p < . ). across all clinical settings and age groups, respondents (n = , ) reported that their top concerns at the time of this survey included: becoming a carrier of covid- (getting self or others sick; . %), being separated from loved ones ( . %), and loss of income ( . %). although nearly all age and setting subgroups reported getting self or others sick as their top-ranked concern, respondents working in private practice reported the loss of income as their most prominent concern at the time of this survey. fewer than % of respondents (n = ) reported that they had no concerns related to the pandemic at the time of this survey. open responses regarding "other concerns" (n = , . %) most often related to health and safety of self and family ( . %), client wellness/access to services ( . %), financial security ( . %), and shifting work responsibilities ( . %). an open-response question at the end of this survey asked the following: "is there anything else that you would like to tell us about your experience since the covid- outbreak?" five hundred ten individuals ( . %) submitted responses to this question. ten central themes emerged within these comments, all of which are outlined in table iv (and expanded supplementary table iv benefits than the difficulties of such services, with many mentioning the lack of access to virtual service delivery options at the time of survey and some expressing mixed perspectives regarding this type of service delivery. this descriptive study explored how the pandemic had affected music therapy employment, contact hours, and service delivery in the united states as of early april . research questions also explored mts' perceived stress and hope during this time in the pandemic. open-ended comments were analyzed in order to gain a greater understanding of the most prominent experiences of mts during this time. the majority of mts ( . %) reported a shift toward alternative service delivery methods during the pandemic, with telehealth emerging as the most frequently utilized service in this category. it is possible that mts shifted to telehealth out of consideration for shelter-in-place orders and quarantine restrictions. mts also serve high-risk populations; therefore, the need for telehealth during the pandemic likely increased in order to keep clients and mts safe. one respondent stated, "telehealth has, by necessity, become a way we can access people who are either in remote locations or who are among the very sick or immunocompromised." therefore, when social distancing protocols began emerging, it appears that many mts recognized the potential of technology to allow continuity of care while also optimizing client and clinician safety. mts quickly adapted to telehealth and used this service more frequently than any other reported service. telehealth, while not an in-person service, still provides a live interaction between the client and therapist, making it useful for working in real-time. mts who continued to deliver on-site clinical services largely shifted from group to individual sessions, again highlighting the impact of the pandemic on the provision of services. despite the willingness of many mts to utilize virtual service delivery methods, many still experienced stark reductions in contact hours or lack of agency/client willingness to consent to alternate services. overall, the private practice/ contractual and education settings appeared to have the largest shift of weekly client contact hours, going from at least hours a week down to nine hours or fewer. respondents employed full-time by agencies and universities reported stable income levels during the pandemic more often than contract-based and private practice mts. private practice employees retained full pay slightly more than practice owners. several private practice owners shed light on this phenomenon by mentioning within comments that they were more willing to cut their own pay than staff pay. this points to the difficult decisions that many mts faced, including choosing the security of others before themselves. mts in medical, mental health, and university settings reported the highest rates of income stability, with fewer of these respondents reporting income elimination. conversely, mts in schools and skilled nursing facilities reported much lower rates of income stability, along with private practice mts. when analyzing income changes across pre-pandemic primary settings and professional roles, private practice mts were the most affected group across both factors. respondents primarily working in private practice were also the only subgroup table iv . to report "loss of income" as their number one current concern. all other respondent subcategories reported carrying or contracting covid- as their most prominent concern. these data indicate that private practitioners may have experienced unique barriers during the pandemic that prevented the continuity of income and services. overall, mts who responded to the survey reported levels of hope that were higher than snyder's ( ) published mean score on the adult hope scale. respondents had higher agency scores than pathways scores, which may suggest that they felt a strong sense of determination or motivation to attain their goals, even though the plausible route may have been less clear. comments from mts indicated that many were ready resume services and "normal" activities. furthermore, comments indicated that mts were faced with many barriers, such as difficulties with telehealth or billing issues. these comments may indicate that, despite a motivation to get back to "normal," mts were dealing with uncertainties as to how they would return to services/daily activities at this point in the pandemic. furthermore, the higher agency scores may be a reflection of motivation that some mts felt in learning new skills to utilize within service delivery. overall, the scores of the adult hope scale were reflected in many of the open-ended hope question responses. comments indicated that mts frequently identified the challenges presented by the pandemic as a positive source of growth for the profession. furthermore, mts made frequent statements on the adaptability and resilience of mts. many respondent comments noted that mts would likely be needed more following the pandemic, specifically to assist in grief work and trauma processing. some mts felt that the public use of the arts for coping and expression during the pandemic may lead to an increased need for creative arts therapies in the future. others identified ways in which the pandemic would provide the means necessary to reach new clients through remote services and new skills acquired during the pandemic. though some mts were frustrated with the transition to telehealth, most who commented on telehealth viewed it as beneficial at the time of the survey. several mts noted the temporality of the situation and shared hope that services would return to "normal" in time. financial instability appeared to cause the most concern for respondents. this included concerns for themselves, for other mts (particularly those in private practice), and for clients and facilities who may no longer have room for services in their budgets. some respondents noted that they were considering leaving the profession, but most cited reasons that were unrelated to the pandemic. although these concerns were prominent, respondents also shared that they felt an increased sense of connection to the music therapy community through resource sharing and emotional support provided online. in regard to the music therapy profession, the majority of respondents ( . %) reported having hope. subgroups with lowest scores on hope for the profession included mts experiencing furlough or eliminated positions. however, a correlation indicated that there was not a strong relationship between hope for the profession and the overall hope score. comments indicated that feelings of hope (and concern) about the profession extended beyond the current pandemic, as ongoing professional issues were at the forefront of responses. many respondents stated that their current levels of hope pertained to advocacy needs, education standards, equity in music therapy practice, state licensure, and ongoing research practices. although not the focus of this study, these topics were clearly of importance to the respondents. the mts in this study had a mean pss- score of . , which is higher than the published normative score of . (cohen and williamson, ) . according to cohen and williamson ( ) , this score reflects the degree to which participants felt unpredictability, uncertainty, and overload in their lives. this seems to confirm literature indicating that novel pandemics create uncertainty (harwood, ) , which may result in heightened stress for healthcare professionals (moazzami et al., ) . this may be further confirmed by the similarity of the mean pss- scores across subgroups for employment changes, essential status, and job settings. although these findings may be an indication of the current situation, more research is needed to determine the perceived stress levels of mts outside of a global pandemic. there was a weak negative correlation between the pss- and total adult hope scale scores, which may indicate that mts maintain a higher perception of hope regardless of situational stressors. since the adult hope scale is meant to capture a person's overall feelings of hope, it may be less sensitive to situational stress, whereas the pss- is designed to capture situational stress. snyder et al. ( ) explored the interaction between stress and hope, finding that people with higher hope scores were able to maintain hope when confronted with stressors. conversely, people with lower overall hope scores demonstrated decreased hope when confronted with stressors (snyder et al., ) . therefore, the observations in this study may indicate that mts were able to maintain hope, despite varying levels of stress at this time in the pandemic. open response analysis revealed an assortment of information that sheds light on the professional, personal, financial, and emotional experiences of mts related to the pandemic. regarding virtual services (the most frequent topic), some mts expressed gratitude for the opportunity to continue earning money and providing services during this time of social distancing. others expressed frustration that virtual service technology is difficult to learn, not appropriate for all clients, and cost prohibitive for many clients and clinicians. additionally, mts mentioned barriers and inequities, which kept clients from accessing these services. personal mental health was the second-most frequent concern within these comments, and respondents in this group often described multiple sources of stress, anxiety, and negative affect change related to the pandemic. many who reported personal mental health concerns also mentioned health/safety concerns, symptoms of burnout, and family balance difficulties. concerns categorized within the personal mental health theme often intersected with expressions of loss and uncertainty related to the pandemic. within the finance, gratitude, and systemic privilege themes, respondents often recognized the hardships and inequities faced by others. even those reporting partial income loss due to the pandemic often expressed personal resilience and empathy for those experiencing increased barriers to economic stability. within the health and safety theme, less than half ( . %) of respondents mentioned concern for their own health risks related to the pandemic, while others focused primarily on protecting individuals at higher risk for severe outcomes. many comments within this theme mentioned the limited availability of personal protective equipment in the workplace, creating barriers related to safe and ethical service delivery. some mentioned that new safety regulations created barriers to effective service access for many clients. despite reports of increased adversity during the pandemic, many respondents used the open comments field as an opportunity to express gratitude for their jobs, for research on the pandemic, for employer support, for their own financial stability, and for the supportive nature of the mt community. in the face of increased collective stress and uncertainty due to the pandemic, the research team found it encouraging to witness evidence of support and resilience within the mt community. as with most survey studies, there is great potential for nonconsent bias within the responses of participants. several respondents mentioned that it can be stressful and unpleasant to reflect on the nature of this pandemic as effects are ongoing, which may have been a key reason for the low response rate. the research team elected to not send follow-up reminders via email due to the sensitivity of the topic; therefore, the survey was promoted via email once. the team wanted to be sensitive to additional stress at this time, thus completion reminders were not sent to non-completers. another limitation was the lack of recent normative data for interpretation of the pss- scores, as well as research regarding mts' pss- scores prior to the pandemic. responses recorded in the open comment section were taken at the end of the survey. given the length of the survey, participants may not have provided additional comments and therefore a broader description may have been missed. this is the first known study on the impact of the covid- pandemic on music therapy professionals' employment, service delivery, stress, and hope. future research should consider the impact of the pandemic over time, as the lasting effects of the pandemic may change aspects of employment, service delivery, stress, and hope. further research on stress and hope would also help indicate if the scores found in this study are outside common ranges for music therapy professionals. additional information on telehealth delivery would be beneficial to inform the profession on how technology was used in service delivery, including platforms, difficulties, and changes to services. the results of this survey provide an overview of changes in employment, service delivery, perceived stress, and level of hope in mt professionals as of april , during the covid- pandemic. the results of the study indicated that mts adapted service delivery in order to continue providing services, despite various difficulties. music therapists also experienced changes in income and client contact hours, with mts in private practice impacted more than mts in other settings. this survey indicated that mts had a moderate perceived stress level while maintaining hope during the challenges of the pandemic. overall, this survey indicated that the pandemic has impacted many mts. as such, it is the central hope from this research team that all mts will gain the resources needed to endure this unparalleled season. supplementary material is available online at music therapy perspectives. funding: none declared. conflicts of interest: none declared. covid- and seeing clients lifestyle behaviours during the covid- -time to connect virtual music therapy service delivery: developing new approaches & models perceived stress scale perceived stress in a probability sample of the united states a global measure of perceived stress guidance for infection control and prevention of coronavirus disease (covid- ) in nursing homes (revised) stress, coping, and hope pandemic uncertainty: considerations for nephrology nurses music therapy practice status and trends worldwide: an international survey study may ). u.s. unemployment rate soars to . percent, the worst since the depression era. the washington post review of the psychometric evidence of the perceived stress scale see which states and cities told residents to stay at home. the new york times covid- and telemedicine: immediate action required for maintaining healthcare providers well-being a survey of music therapy students' perceived stress and self-care practices pandemic influenza: certain uncertainties lockdown and isolation: psychological aspects of covid- pandemic in the general population what guides internship supervision? a survey of music therapy internship supervisors. music therapy perspectives hope theory: rainbows in the mind the will and the ways: development and validation of an individual-differences measure of hope making sense of cronbach's alpha who director-general's opening remarks at the media briefing on covid- - key: cord- - i uv authors: zhou, jacy; blaylock, rebecca; harris, matthew title: systematic review of early abortion services in low- and middle-income country primary care: potential for reverse innovation and application in the uk context date: - - journal: global health doi: . /s - - -z sha: doc_id: cord_uid: i uv background: in the uk, according to the abortion act, all abortions must be approved by two doctors, reported to the department of health and social care (dhsc), and be performed by doctors within licensed premises. removing abortion from the criminal framework could permit new service delivery models. we explore service delivery models in primary care settings that can improve accessibility without negatively impacting the safety and efficiency of abortion services. novel service delivery models are common in low-and-middle income countries (lmics) due to resource constraints, and services are sometimes provided by trained, mid-level providers via “task-shifting”. the aim of this study is to explore the quality of early abortion services provided in primary care of lmics and explore the potential benefits of extending their application to the uk context. methods: we searched medline, embase, global health, maternity and infant care, cinahl, and hmic for studies published from september to february , with search terms “nurses”, “midwives”, “general physicians”, “early medical/surgical abortion”. we included studies that examined the quality of abortion care in primary care settings of low-and-middle-income countries (lmics), and excluded studies in countries where abortion is illegal, and those of services provided by independent ngos. we conducted a thematic analysis and narrative synthesis to identify indicators of quality care at structural, process and outcome levels of the donabedian model. results: a total of indicators under subthemes were identified to examine the quality of service provision: law and policy, infrastructure, technical competency, information provision, client-provider interactions, ancillary services, complete abortions, client satisfaction. our analysis suggests that structural, process and outcome indicators follow a mediation pathway of the donabedian model. this review showed that providing early medical abortion in primary care services is safe and feasible and “task-shifting” to mid-level providers can effectively replace doctors in providing abortion. conclusion: the way services are organised in lmics, using a task-shifted and decentralised model, results in high quality services that should be considered for adoption in the uk. collaboration with professional medical bodies and governmental departments is necessary to expand services from secondary to primary care. in england and wales, the criminalisation of abortion persists as a source of stigma, discrimination against women, and hinders provision of patient-centred clinical practices [ ] . according to the abortion act, all abortions must be approved by two doctors, reported to the department of health and social care (dhsc), and can only be performed by doctors within licensed premises [ ] . this legal framework causes accessibility issues, especially in rural communities lacking in both medical facilities and providers, and prevents the development of other innovative models, such as nurse/midwife-led surgical services [ ] . the uk is unable to implement the who recommendation for services to optimise health worker roles in healthcare systems such as primary care because of the legal restrictions [ ] . at the cairo international conference on population and development (icpd), over governments agreed that reproductive health care should be an integral part of primary health care and should be accessible in all countries "to all individuals of appropriate ages as soon as possible and no later than " [ ] . several professional medical bodies, including the british medical association (bma), the royal college of gynaecologists and obstetricians (rcog), and the royal college of general practitioners (rcgp) [ ] [ ] [ ] , advocate for the decriminalisation of abortion in england and wales, stating that it will remove unnecessary barriers and improve the current clinical practice. following recent successes in expanding sexual and reproductive rights in the republic of ireland and northern ireland, there is increasing pressure to decriminalise abortion in england and wales [ , ] . this warrants the exploration of new service models which would be available after decriminalisation and could improve current practice. in low-and-middle-income countries (lmics), resource constraints motivate policymakers to rethink existing processes and make decisions that are cost effective [ ] . providers then leverage regulatory gaps to adopt "frugal innovations" [ ] . reverse innovation occurs when products/services that are highly effective and scalable penetrate marginalised markets of high-income countries (hics); and for service models, core elements are extracted and adapted for local conditions [ ] . abortion services have long been part of primary care in lmics and are sometimes "task-shifted" to mid-level providers (mlps), such as nurses or midwives. some studies from lmics have shown that surgical abortions (sa) can be safely and effectively performed by mlps in the primary care setting of lmics [ , ] . the advent of early medical abortion (ema) has further enabled the provision of safe abortion in a simple health facility with few requirements for technology or any surgical skills [ ] . understanding the potential value and challenges of reverse innovation for potential primary care abortion services in the uk is necessary to make strong evidence-based propositions for future policy and legislative changes [ ] . in this article, we will: systematically review the evidence base for firsttrimester abortion services in primary care of lmics, use a narrative synthesis approach to analyse the quality of abortion services with specific indicators organised around the donabedian model, and consider the opportunities and challenges for the development of such services in the uk. this systematic review was conducted using covidence™ [ ] , and in accordance with the prisma statement, refer to additional file [ ] . we searched databases medline, embase, global health, maternity and infant care, cumulative index to nursing and allied health literature (cinahl) and health management information consortium (hmic) (grey literature database) for studies published between september to february (additional file : full search strategy). all searches were limited to papers written in the english language. other relevant papers were identified by citation searching and reference checking. we used a pi(c)os framework to establish search terms and selection criteria (additional file : search terms and selection criteria) [ ] . the population was defined as all healthcare providers strictly in primary care settings, according to the who definition [ ] . studies in secondary and tertiary settings were excluded. ngo-led services were also excluded as they are semiautonomous and may be separate from formal healthcare systems depending on country. population was further refined by country, including those classified as "low income," "lower-middle income," and "upper-middle income", and those where abortion is not entirely prohibited (additional file : list of lmics) [ , ] . who recommends mg mifepristone administered orally, followed - days later by μg misoprostol administered vaginally, sublingually or buccally [ ] . the chosen cut-off date as the cairo international conference on population and development (icpd) was a turning point for sexual and reproductive health rights. governments were urged to impose less punitive measures on women seeking abortion, provide safe abortion services and measures to manage complications resulting from unsafe abortions. who defines primary care (pc) as the gate keeper to healthcare services and is where "first-contact, accessible, continued, comprehensive and coordinated care" occurs [ ] . according to the world bank according to world abortion law the intervention was defined as early abortion (medical or surgical), where "early" implies a pregnancy under weeks of gestation [ ] . no comparators were considered as this review is an exploration of existing literature. the outcome was defined as the quality of abortion services, including themes outlined by dennis et al. shown in table [ ] . only peer-reviewed primary studies were included. a list of excluded studies can be found in additional file . the quality of papers was assessed using a standardised checklist from the mixed methods appraisal tool (mmat) [ ] . this tool was chosen due to the heterogeneity of included papers. an extensive scoring guide and an overall quality score was given for each included study. a detailed assessment of each paper was also conducted, refer to additional file . a narrative synthesis analysis was used due to the heterogeneity of included studies. jz extracted the data using a standardised template and summarised the results narratively. rb was involved in identifying relevant themes and reaching a consensus on the data extracted. a thematic analysis was conducted to assess the quality of abortion services according to various quality various indicators at the structural, process, and outcome levels. table shows the indicators of quality abortion care used in this study. figure shows the prisma flow diagram of this study [ ] . an initial search yielded titles. sixty-nine studies were selected for full-text review and an additional studies were identified by forward and backward snowballing. we identified studies for inclusion, of which there were eight implementation studies, three cross-sectional studies, three prospective cohort studies, two qualitative studies and two randomised controlled trials (rct) (prisma diagram in fig. ). we describe the included study characteristics in table (see additional file for further details). included studies were conducted in eight countries -bangladesh [ ] , democratic people's republic of korea (dprk) [ ] , ethiopia [ ] , india [ , , , ] , kyrgyzstan [ ] , nepal [ , , , , , , , ] , nigeria [ , , ] and south africa [ ] . with reference to dennis et al. [ ] , we identified a total of indicators to assess the quality of abortion services in eight subthemes, organised under three table indicators of high-quality early abortion care explored in this review, adapted from dennis et al. [ ] theme subtheme indicators of high quality •abortion care must be accessible and not limited by administrative or policy barriers. •regulations, guidelines and other policy documents have been developed, approved by national/sub-national governments, and/or disseminated to health care facilities that are supportive of access to safe abortion care consistent with who guidance. •efficient, high-quality referral systems are in place. •essential equipment, supplies and medications are available in sufficient quantity to address needs. •abortion is provided in a facility with space for privacy. •appropriate pain management techniques are in place. •physical assessments of general and sexual and reproductive health are performed (including confirmation of gestational age). •staff follow approved guidelines and protocols for medical, surgical, and incomplete abortion. •staff use appropriate technologies. •follow-up care is provided, where client's experience with abortion and pregnancy status are assessed. •staff explain all aspects of abortion care to clients (current condition, treatment plan, follow-up needs, and potential post-abortion complications and how to obtain appropriate post-abortion care). •staff provide clients the opportunity to express concerns, ask questions, and receive accurate, understandable answers. •staff offer respectful care. •staff work to ensure privacy during the visit. •staff provide confidential care. •staff hold non-judgemental attitudes. •staff-client interactions promote an atmosphere of trust. ancillary services •staff directly provide or offer referrals for a range of sexual and reproductive health services, including contraception and screening and treatment for hiv and stis. outcome abortion outcomes •there is low number of admissions for treatment of abortion complications. •there is a low percentage of maternal deaths as a result of abortion a . •clients are satisfied with abortion care a according to who in , mortality rate due to unsafe abortion was at deaths per , live births ( %) worldwide. in developed regions, mortality rate due to unsafe abortion was . deaths per , live births ( %); in developing regions, mortality rate due to unsafe abortion was deaths per , live births ( %) [ ] sections: ( ) structural indicators: law and policy, infrastructure; ( ) process indicators: technical competency, information provision, client-provider interactions, ancillary services; ( ) outcome indicators: abortion outcomes, client satisfaction. the following is a narrative analysis of the abortion services and the contexts in which they operate, detailed in the included studies. lmics are disproportionately affected by restrictive abortion laws, therefore unsafe abortions are extremely common in affected countries and result in high maternal mortality rates. in response to this phenomenon, the bangladeshi government sanctioned "menstrual regulation" (mr), a process to remove the uterine lining using surgical or medical methods, whether the woman is pregnant or not, henceforth enabling one to legally seek help through primary care services [ ] . liberal abortion policies encourage safe abortion services and reduce maternal mortality [ ] . countries (india, ethiopia, nepal, kyrgyzstan, dprk, south africa) with liberal abortion law have well-established policies and guidelines for service provision [ - , - , - ] . nepal and ethiopia have distinguished themselves from the rest, both adopting proactive and liberal measures to integrate medical abortion (ma) services in their local healthcare system by implementing national guidelines and task-shifting services to mlps [ , , , , , , , ] but the results are vastly different. nepal became a widely successful case and a regional leader of innovative abortion services while ma services are still lacking in ethiopiaonly . % of providers surveyed have received abortion training, and a majority ( . %) felt uncomfortable working in a facility that provides abortion due to religious and personal reasons [ ] . while a supportive government is necessary to introduce new policies, sociocultural factors such as religion and moral believes can hinder their success. andersen et al. [ ] reported a third of trained auxiliary nurse-midwives (anms) did not provide ma due to the lack of appropriate equipment and medication in nepal. ma was rarely provided in nigeria due to the high costs of drugs and tighter restrictions, but clinics were wellequipped to provide sa for incomplete abortions [ ] . in south africa, high medication cost was also a barrier to ma provision [ ] . ma combination packs in india and bangladesh made self-medication safer and more intuitive for women, expanding its access to local pharmacies [ , ] . some primary care clinics were unequipped to manage ma complications, but all studies detailed referral systems to secondary or tertiary care [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . privacy in facilities is essential to creating a safe environment for women, especially in communities where abortions are strongly associated with shame and discrimination. three studies mentioned the lack of private space as an additional barrier to expanding ma services [ , , ]. yet, this was only made necessary in cohort studies and rct studies [ , , , , , , , , ] . no cross-sectional studies mentioned privacy, so its actual practice is lesser known. only andersen et al. reported the actual proportion of private rooms in their nepal study - % in primary health centres and % in health posts [ ] . technical competency ma is recommended by the who as a safe and effective method for abortion in the first trimester [ ] . while ma becomes increasingly popular globally, surgical methods remain popular in nigeria and india due to several reasons. ( ) providers have poor knowledge of ma regimen due to lack of training, i.e. most nigerian doctors are only familiar with misoprostol as a drug for stomach ulcers as it is not licensed for ma [ , ] ; and india has non-standardised ma treatment as providers often rely on their intuition or personal experience to determine the "correct" dosage and regimen [ ] . ( ) high cost of medication was a barrier to accessibility, especially in rural areas of india with severe lack of funding [ ] . ( ) a resistance to change, as providers still prefer surgical methods for being marginally "quicker and easier", and less prone to complications compared to ma [ , ] . ( ) the burden of responsibility placed on clients to self-manage their mahence providers may omit those who are uneducated (who may have difficulty comprehending instructions) and those living faraway (as heavy bleeding starts on the journey back home), as it can cause a greater inconvenience overall [ ] . several studies reported that nurses and midwives gained confidence with ma through ample training and practice, hence improving workflow [ , , , , , , , , ] . nevertheless, some suggested follow-up interventions to ensure long-term effectiveness, such as provider support networks and follow-up practice assessments [ , ] . several studies used an ultrasound scan to confirm gestational age of the pregnancy, but later have considered it unnecessary in most cases, consistent with who recommendations [ , , , , , ] . pain medication was provided to over % of clients in most cohort studies and rct studies [ , , ] , but actual practice may be as low as %, observed by banerjee et al. in india [ ] . ramachandar and pelto [ ] highlighted the importance of effective communication in ma as providers have less control over its outcome, relative to sa. this entails providing accurate and adequate information in a clear and concise manner to manage client expectations and reduce complications [ ] . in several studies, providers were trained to brief clients on the procedure, side effects and complications of abortion [ , , - , , , , - ] . however, actual practice largely depends on provider's knowledge and communication skills. banerjee et al. [ ] reported that % of providers explained the ma procedure to clients, % explained the possible side effects, and no providers counselled on complications. some providers were unsure of what constituted a complication and had various ways of classifying expected effects such as pain and bleeding: "some doctors did not have clear idea of what's normal bleeding" [ ] . although studies reported a majority of their clients were at least "somewhat prepared" for the procedure in india and kyrgyzstan, other studies in nepal and bangladesh show that some clients experience ma with unaddressed questions [ , , , ] . clients in india and nepal experienced judgement from providers and were treated with disrespect due to the stigma associated with abortion in some contexts [ , ] . one provider restricted ma by the clients' social status and education level, believing urban clients can better comprehend the instructions [ ] . since selfmedication places a greater emphasis on client knowledge, selectively providing ma may reduce mismanagement, but may inadvertently deprive women in lower social status of ma, especially those in challenging situations, such as aborting without a partner's or family's consent. providers who ensured confidentiality improved client's trust and comfort during the abortion process. in nepal, the majority of clients valued the confidential support in clinics as they could receive abortion without informing their family members [ , ] . nurses/midwives-led services also improved trust and built strong rapport with women within local communities, as they were posted to each health stations longer than physicians [ , ] . provision of contraception may be as low as %, reported by benson et al. across nigeria, nepal and india [ ] . short-term contraceptives such as condoms, pills and injectables are popular with clients, whilst longacting reversible contraceptives (larc) such as intrauterine devices and implants are less popular [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] ] . one study claimed that given the poor accessibility to health facilities in rural areas, expanding the provision of larc is important to prevent any unwanted pregnancies [ ] . the majority of studies showed at least a % complete abortion rate, consistent with the international benchmark [ , - , , , , ] . only one study failed to meet %, attributed to the provider's lack of experience with ma. all incomplete abortions were either resolved by surgical aspiration in the primary care clinic itself or through a referral to a hospital [ , - , , , , ] . most clients were satisfied with the abortion services they received and would recommend them to their friends [ , , , , ] . although satisfaction levels were subjective to clients, tamang et al. [ ] showed that high satisfaction rates were related to experiences of shorter length of abortion, a less-thanexpected amount of bleeding and high-quality counselling. sa outcomes were not investigated as cross-sectional studies did not allow for patient follow-up [ , ] . in this review, we explored the quality of first-trimester abortion services provided in primary care clinics of lmics, using indicators organised around the donabedian model. in this service model, we observed an efficient workflow that optimised workforce while ensuring safety and client satisfaction. compared to the classic linear relationship in a donabedian's model, our results postulate a mediation pathway where good structure directly promotes good outcome and process, which in turn also promotes good outcome [ ] . this pathway underscores the importance of structural components, but our review also showed that policies and infrastructure are insufficientfor example, in countries such as ethiopia where pro-choice government policies do not necessarily result in accessible abortion services. many doctors in nigeria and india still favoured sa, and some clinics were well-equipped to perform mva in the event of incomplete abortion. we cannot comment on provider's competency and knowledge of sa as there was little evidence in the recent literature. as the worldwide trend changes from sa towards ma, our review shows that these components are essential for quality ma services: ( ) a safe and private space to ensure client confidentiality for in-clinic abortion, due to its longer duration relative to sa; ( ) a standardised understanding of arbitrary side effects, such as bleeding and pain; ( ) a strong rapport between clients and providers as ema focuses on self-medication. multiple studies also showed the success of taskshiftingnurses and midwives can effectively replace doctors in abortion services when well-trained and supported. redistributing low-skilled tasks can optimise efficiency and improve work satisfaction across all providers, thereby combatting healthcare workforce shortages [ ] . passing tasks to midwives and nurses can also build a stronger rapport between provider and clients as they are sometimes able to commit to a local community in the longer-term [ ] . task-shifting is increasingly feasible with the popularity of ma as it requires less technical skills than sa [ ] . shifting the task to well-trained mlps expands the provider network, thereby increasing service availability. this review showed that provision of first trimester ma (ema) in primary care services is safe, feasible and acceptabledecentralising abortion services to primary care and task-shifting will increase availability and accessibility. in the us, studies support the integration of ema into its primary care system as it essentially uses skills that primary care providers already practice [ , ] . some countries, such as australia, france, and the netherlands, already provide ema in primary care clinics [ ] [ ] [ ] . in england and wales, primary care teams in general practice (gps) or sexual health clinics (shcs) already provide counselling, pre-abortion screening, and referral into abortion services [ ] . former rcog president, anthony falconer expects the line between primary and secondary women's healthcare to become fuzzier with more "gynaecological issues" resolved within the community, and the rcog also proposed a "life-course approach" to women's health starting in primary care [ , ] . in recent years, members of parliament across the house of commons have shown overwhelming support for the decriminalisation of abortion [ , ] . if this is achieved, ema services will potentially expand to primary care and align with the nhs long term plan, aimed at facilitating a stronger collaboration between primary and secondary care service for an integrated approach [ ] . this expectation necessitates secondary-based trainings for primary healthcare practitioners to ensure technical competency. in rcog's workforce survey of uk consultants, only . % (around % of ob/gyn specialists) included abortion as part of their work [ ] . expanding ema services to gp clinics would increase the number of trained health professionals that perform simple abortion procedures, freeing up specialists for more urgent, complicated cases, such as those seeking abortion in later in pregnancy. nevertheless, some challenges need to be addressed while implementing change. convincing stakeholders of the potential value that "frugal innovations", such as task-shifting, can bring to the nhs is complex. innovations from lics are often discounted or given shorter shrift, and research from these settings is rated worse based on their country of origin [ ] [ ] [ ] , complicating the diffusion of learning from these contexts. nonetheless, the extensive experience of primary care ema in these countries suggests that there is much that could be learned by the uk. there is a risk that introducing ema into primary care in the uk may increase burden on gp clinics, already face issues of long-waiting hours and workforce shortages. careful planning would be required to ensure that additional services do not result in a greater inefficiency and cost to the nhs. our review had several limitations. first, a disproportionate number of ma papers were included thus less is understood on sa services in primary care due to a paucity of evidence. we also excluded services delivered in ngo clinics as they were not strictly primary healthcare but are often similar in make-up to primary care clinics and sometimes, the sole providers of abortion services in some lmics. second, a majority of included studies were in a controlled environment, where provider practice was standardised by strict protocolstherefore, results may not represent actual practice, and this also reflects a gap in the current literature as more cross-sectional studies should be conducted to give a full picture. lastly, only two of the studies were qualitative studies, but they contributed more insight in our review as their narrative form provides a deeper understanding of the phenomenon compared to quantitative studies. our review is the first to consolidate quality of abortion services provided in primary care clinics of lmics. using the dennis et al. framework, we determined the components necessary for a successful abortion service in primary care clinics. overall, we conclude that ema provision in primary care is safe and feasible, and that implementing a similar service in the uk could improve access without compromising on quality. the next steps would be a cost estimation of integrating an ema service into gp clinics, and an economic evaluation to make a strong business proposition. acceptability and feasibility studies would be required to explore the underlying conditions of primary care ema. qualitative studies would also provide an in-depth understanding of attitudes primary care providers and women have towards primary care ema. the recent covid- outbreak further builds a strong case for changing policies to match the evidence base. telemedical ema was approved in england, scotland and wales, so women can now receive ema at home, via nurse-led telephone consultations and medical abortion packs sent in the post [ ] . the temporary approval of this service sets a precedent for abortion-service innovation, and moving forward, we believe implementing ema in the uk primary care system can complement telemedical services to provide women with face-to-face care in their own community. we also further recommend that further research is conducted to inform and enable taskshifting of first trimester surgical abortions to nurses and midwives in uk primary care. supplementary information accompanies this paper at https://doi.org/ . /s - - -z. the decriminalisation of abortion: an argument for modernisation abortion statistics for england and wales accessed abortion act fifty years on: abortion, medical authority and the law revisited world health organization, and unaids. safe abortion: technical and policy guidance for health systems. world health organization united nations decriminalisation of abortion: a discussion paper from the bma royal college of obstetricians & gynaecologists. rcog backs decriminalisation of abortion rcgp to support decriminalisation of abortion irish abortion referendum: ireland overturns abortion ban northern ireland to legalise abortion and same-sex marriage turning the world upside down reverse innovation: create far from home, win everywhere can reverse innovation catalyse better value health care? can nurses perform manual vacuum aspiration (mva) as safely and effectively as physicians? evidence from india rates of complication in first-trimester manual vacuum aspiration abortion done by doctors and mid-level providers in south africa and vietnam: a randomised controlled equivalence trial world health organization. medical management of abortion. world health organization introducing medical abortion within the primary health system: comparison with other health interventions and commodities reverse innovation a systematic literature review covidence systematic review software, veritas health innovation preferred reporting items for systematic reviews and meta-analyses: the prisma statement systematic reviews: crd's guidance for undertaking reviews in health care world health organization. primary healthcare the world's abortion laws world bank country and lending groups clinical practice handbook for safe abortion identifying indicators for quality abortion care: a systematic literature review accessed unsafe abortion: global and regional estimates of the incidence of unsafe abortion and associated mortality in mixed methods appraisal tool (mmat), version . registration of copyright (# ), canadian intellectual property office, industry canada expansion of safe abortion services in nepal through auxiliary nurse-midwife provision of medical abortion knowledge, attitude and practice (kap) of health providers towards safe abortion provision in addis ababa health centers evaluation of a network of medical abortion providers in two districts of maharashtra improving health worker performance of abortion services: an assessment of post-training support to providers in india, nepal and nigeria provision of medical abortion by midlevel healthcare providers in kyrgyzstan: testing an intervention to expand safe abortion services to underserved rural and periurban areas integrating medical abortion into safe abortion services: experience from three pilot sites in south africa. j fam plan reprod health care increasing access to safe abortion services through auxiliary nurse midwives trained as skilled birth attendants women's experiences with medication for menstrual regulation in bangladesh increasing access to safe abortion services in rural india: experiences with medical abortion in a primary health center private medical providers' knowledge and practices concerning medical abortion in nigeria. stud fam plan attitudes and practices of private medical providers towards family planning and abortion services in nigeria pharmacy access to medical abortion from trained providers and post-abortion contraception in nepal the role of auxiliary nurse-midwives and community health volunteers in expanding access to medical abortion in rural nepal medical abortion in rural tamil nadu, south india: a quiet transformation effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: a non-inferiority study in nepal comparative satisfaction of receiving medical abortion service from nurses and auxiliary nurse-midwives or doctors in nepal: results of a randomized trial feasibility, efficacy, safety, and acceptability of mifepristone-misoprostol for medical abortion in the democratic people's republic of korea can midlevel health-care providers administer early medical abortion as safely and effectively as doctors? a randomised controlled equivalence trial in nepal abortion worldwide : uneven progress and unequal access comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review effectiveness of an integrated approach to hiv and hypertension care in rural south africa: controlled interrupted time-series analysis providing abortion services in the primary care setting. women's health, an issue of primary care: clinics in office it is time to integrate abortion into primary care unplanned pregnancy: abortion accessed interruption volontaire de grossesse (ivg) avortement prix reproductive health care in the netherlands: would integration improve it? reprod health matters the care of women requesting induced abortion: evidence-based clinical guideline number better for women, improving the health and wellbeing of girls and women. london: royal college obstetricians and gynaecologists the nhs reforms: what they will mean for generalist and specialist clinicians abortion rights are on the ballot this general election -years-since- -abortion-act-passedmajority-of-mps-now-have-a-more-liberal-position-on-abortion royal college of obstetrician and gynaecologist. call for evidence on abortion in the developing world and the uk review of operational productivity in nhs providers: interim report judgment under uncertainty: heuristics and biases does a research article's country of origin affect perception of its quality and relevance? a national trial of us public health researchers accessed explicit bias toward high-income country research: a randomised, blinded, crossover experiment in english clinicians the abortion act : approval of a class of places publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations additional file appendix s . . medline search strategy (via ovid). appendix s . . embase search strategy (via ovid). appendix s . . global health search strategy (via ovid). appendix s . . maternal and infant care search strategy (via ovid). appendix s . : health management information consortium search strategy (via ovid). appendix s . . cinahl (via ebsco). appendix s . prisma checklist. all authors were involved in study design, drafting of manuscript, providing comments and suggestions for the review. rb originated the study. mh and rb provided guidance on the framework and direction of the review. rb wrote and redrafted manuscripts and reviewed articles. jz conducted literature searches, reviewed articles, wrote and drafted the manuscripts. the author(s) read and approved the final manuscript. the authors received no funding for this article. mh is supported in part by the nw london nihr applied research collaboration. imperial college london is grateful for support from the nw london nihr applied research collaboration and the imperial nihr biomedical research centre. the views expressed in this publication are those of the authors and not necessarily those of the nihr or the department of health and social care. key: cord- -gotctl d authors: arnout, boshra a. title: predicting psychological service providers' empowerment in the light of the covid‐ pandemic outbreak: a structural equation modelling analysis date: - - journal: couns psychother res doi: . /capr. sha: doc_id: cord_uid: gotctl d this study aimed to investigate the predictors of psychological service providers' empowerment in the light of the covid‐ pandemic outbreak. the researcher prepared a psychological service providers' empowerment scale that consisted of items, and this scale was applied in a random sample consisting of psychological service providers. the results showed that the empowerment scale has acceptable validity and reliability. the results of the exploratory factor analysis indicated that the scale items saturate on seven factors, which accounted for . % of the total variance of the scale: the first factor named expect psychological services effectiveness accounted for . %, the second factor named self‐stimulation accounted for . %, the third factor named responsibilities and duties accounted for . %, the fourth factor named psychological services work environment accounted for . %, the fifth factor named psychological service providers’ decision‐making accounted for . %, the sixth factor named creative psychological service provider behaviour accounted for . %, and the seventh factor named psychological services confidence accounted for . % of the total variance of a psychological service providers' empowerment. in order to study the ability to predict the empowerment among psychological service providers, the researcher developed a structural model for psychological service providers' empowerment and then used the structural equation model analysis. the results showed that the proposed structural model of a psychological service providers' empowerment has goodness‐of‐fit, and these results emphasised the ability to predict psychological service providers' empowerment by seven tested factors. empowering the individual increases their creativity, excellence and innovation. because of the importance of the profession of psychological services in the preparation of members of society psychologically, it is necessary to pay attention to the empowerment of psychological service providers to achieve the quality of psychological services provided to beneficiaries, that is matching the current performance of the psychological service providers with the needs and expectations of psychological service providers at different ages and social and professional levels of society, and accuracy and comprehensiveness. arnout, al-dabbagh, et al. ( ) and arnout, alshehri, assiri, and al-qadimi ( ) discuss the origins of covid- as a new strain of virus that was discovered in and has not been previously identified in humans. common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. in more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death (who, ) . on march , the director-general of the world health organisation (who) declared the spate of infections caused by sars-cov- (covid- ) a pandemic. as this situation continues without a specific date for the return of life to what it was before covid- , the stresses increase, and many suffer from the inability to adapt to the current circumstances. it is not easy for our professionals and health officials to ask us to 'socialise', but it is incompatible with human nature. man is a social being by nature. social divergence is simply avoiding gatherings and close contact with others. health experts consider it crucial to slow the spread of the virus, to avoid overburdening healthcare systems and perhaps to protect them from collapse if infection rates rise to a level that cannot be dealt with efficiently (arnout, ) . in quarantine, some of the psychological stresses that people suffer from include the following: . longer periods of quarantine were associated with symptoms of post-traumatic stress, reluctance and anger. . quarantined people feel fear for their health or have suffered fears of injuring others. . quarantined people felt angry and bored, due to restrictions, daily routine loss and lack of social and material contact with others. . inappropriate basic supplies (such as food, water, clothing or accommodation) during quarantine caused frustration, which was associated with anger and anxiety. . obtaining inappropriate information, including clarity about the actions to be taken, the purpose of quarantine and the different levels of risk, has proven to be stressful. these stresses are associated with the quarantine. if a person is not able to confront it with effective styles of coping, it may lead him or her to experience psychological problems, and perhaps mental illness. many patients who recovered from the spanish flu in suffered from long-term depression and lethargy, feeling dizzy, experiencing insomnia, hearing or odour loss, and blurring of vision. some believe that an outbreak of coronavirus will lead to a similar explosion in depression after recovering from the virus. caring for mental health in such difficult times is extremely important. that is why the need of community members for psychological services increases under these conditions of quarantine and social separation, and the psychological problems it creates. almutairi, adlana, balkhya, abbas, ( ) stated that the spread of infectious viruses such as sars and others provokes emotional, ethical and cultural conflicts in the healthcare providers' work environment, which affects the quality of care they provide to patients with infection. the findings of arnout, al-dabbagh, et al. ( ) and arnout, alshehri, et al. ( ) indicated that the increased prevalence of covid- has a negative effect on the mental health of individuals. in the same context, infection with deadly viruses results in self-stigma and external stigma. recently, overholt et al. ( ) found that during follow-up, stigma levels were stable. baseline stigma significantly increased during enrolment and following clusters of ebola re-emergence in liberia. survivors encountered primarily enacted and perceived external stigma rather than internalised stigma. in addition, james, wardle, steel, and adams ( ) found that evd-related stigma (internalised and enacted) is prevalent among evd survivors since their return to their communities. almutairi and his colleagues in their qualitative study in found that the healthcare providers who survived mers-cov in saudi arabia perceived prejudice behaviours and stigmatisation, lived moments of traumatic fear and despair, and denial and underestimation of the seriousness of the disease at the individual and organisational levels, and they recommend further studies to investigate the public's perceptions of the nature of the mers-cov infection and their views and reactions. thus, it is clear that the spread of the covid- pandemic negatively affects the professional performance of healthcare providers, and thus reduces the quality of the professional assistance services they provide to the clients and their ability to perform their professional work. previous studies (robinson et al., ) recommended to examine the coping and stress management techniques for healthcare workers in conditions of infectious disease outbreaks. empowerment is a relatively new term, referring to a mental state that qualifies an individual to do something through a sense of inner commitment, self-control and a sense of trust, which contributes to the generation of human activity, the realisation of reason and creativity and the achievement of the desired goals in life in all its aspects. empowerment has therefore become a prerequisite for living in the modern age, full of changes and developments in various aspects of life. empowerment is essential for students, employees, parents and all members of society of all ages and their personal, mental and professional qualities, especially for humanitarian workers (arnout, ) . empowerment refers to the extent to which an individual has control over his or her sources of strength. empowerment is therefore linked to a qualification aimed at assisting an individual with a physical, mental or sensory disability to reach the maximum performance an individual can achieve in his or her personal tasks, for example where he or she is a member of an institution or in the community in which he or she lives. the concept of empowerment has recently entered the field of social sciences, which means that an individual can gather and use all sources of power in his or her social life, including his or her relationships and work (kafafi & salem, ) . empowering the psychological service provider in their work enables them to become aware of all of their responsibilities and duties. the psychological service provider is fully and comprehen- al-nawajhah ( ) stated that empowerment is a broad concept that accommodates many synonyms, meanings and concepts such as strengthening and enhancing efficiency and improving the situation and attribution. the study of the subject of psychological empowerment is a relatively recent topic in the humanities, especially in the science of educational and psychological management. its manifestations are efficiency, self-efficacy, the ability to perform tasks and influence work, a sense of the value and meaning of work, self-motivation and ability to overcome feelings of frustration and despair. empowering the psychological service provider is one of the pillars of the success and excellence of the psychological services process. in the light of the technological development and its implications on the psychological services process on the one hand, and the change in life in all its aspects, and the increasing challenges imposed on members of society, and the responsibilities, duties and burdens imposed on psychological service providers' empowerment as a result of the increasing suffering of the members of the community and the stress on them, there is a need to improve psychological service providers' empowerment in their work, increasing their level of performance and increasing interest in the psychological services process. previous studies emphasised the role of empowerment in the workplace. hardina ( ) and he, murrmann, and perdue ( ) found that employee empowerment has positive effects on job satisfaction and the service quality they provide to their clients. in the light of the increasing stresses resulting from the outbreak of the covid- pandemic, given the importance of empowering mental health service providers, healthcare institutions and organisations are responsible for development of clients through planning training programmes. the theoretical basis of the concept of empowerment is the theory of social exchange. it depends on the process of self-perception of the importance of the individual and his or her role in the work performed. bowen and lawler ( ) defined it as an internal state of mind that needs to be adopted and represented by the individual, in order to have self-confidence and conviction with the cognitive abilities that help them to make decisions and choose the results that they want to reach (al-nawajhah, ) . empowering the psychological service provider means 'giving the psychological service providers the opportunity to perform all his or her duties and responsibilities and fully exercise his or her authority at all stages and aspects of the psychological services work, making him or her able to face the challenges, stresses, professional development and changes in all aspects of life, and overcome obstacles that they may face during the psychological services practice and affect positive effectiveness of the professional guide and increases in his or her loyalty to the profession and motivation towards excellence and creativity in performance'. this empowerment of the psychological service provider is the first building block of creativity in the work of psychological services, because it allows the growth of mutual trust between the service provider and the client, and between them and their colleagues, and provides an opportunity for the psychological service provider to enable themself during the stages of the psychological services process and involve themself in decision-making and taking responsibility and carrying out activities and duties to improve the feelings of motivation, self-efficacy of the individual, positive behaviour, building of positive relationships with clients, rooting respect, trust, understanding, participatory cooperation and enjoying psychological services work. | arnout . | the dimensions of psychological service providers' empowerment kaddour and mohammed ( ) stated that one of the earliest perceptions of the concept of empowerment was developed by zimmerman ( ) , in which they presented three dimensions of measuring psychological empowerment: values, processes and outcomes. in addition, spreitzer ( ) introduced four dimensions to measure psychological empowerment: sense of sense, efficiency, self-determination and impact. menon ( ) envisaged three dimensions of empowerment: perceived control of the individual environment, perceived competence in task accomplishment and goal entry. al-nawajhah ( ) also mentioned the dimensions of psychological empowerment according to thomas and velthouse ( ) , which consider that psychological empowerment has four dimensions: this is concerned with the values of the goal and tasks that are judged by the criteria or ideas of the individual, and includes giving meaning to the work comparison between the requirements of the role of work and beliefs of the individual. the degree to which an individual can perform the activities and tasks assigned to them with high skill when trying. the degree to which behaviour is perceived to make a difference in relation to the achievement of a goal or task, which in turn has the intended effect in an individual's environment. includes causal responsibility for the actions of the individual, and the opportunity to choose the tasks that are meaningful to him or her and perform in a manner that seems appropriate. from the above, we can determine the following seven dimensions of psychological service providers' empowerment: . expect psychological services effectiveness: this refers to the psychological service provider's expectation of their ability to perform their duties and responsibilities, as well as their ability to provide psychological services to the client, and their awareness that they are capable of solving the problem of the client, their self-determination and independence. the more empowered a psychological service provider is, the more effective they will be in carrying out their work and tasks. it is intended for the psychological service provider to feel that they have the authority to take personal responsibility in the psychological services process and to receive recognition and support from colleagues and clients of the psychological services, and to help them feel the achievement of the psychological services' aims. . psychological service providers' decision-making: it is intended that the ethical framework of the psychological services profession defined the right of the psychological service provider to take the decisions governing the psychological services work and move in the direction of achieving the desired aims, whether the decision to continue work with a client and professional assistance specialist, or the decision to choose the appropriate method and techniques to solve the problem of the client for which the psychological services came, or the decision to terminate the relationship with the client and refer them to another psychological service provider, because this enables the psychological service provider to take responsibility to solve the problem of the client and satisfy the psychological needs. . creative psychological service behaviour: it is intended to distinguish professional psychological services, in providing new psychological services in unusual ways, which enables them to solve the problem of the psychological service in creative ways. it collects data and analyses them in a new way and evaluates alternatives to solve them and selects the most appropriate alternative to achieve greater benefits for the psychological services. . psychological services confidence: it is intended to guide the confidence of the psychological service provider in their performance, as well as confidence between them and their colleagues in the profession, and between them and their clients so that they can perform their duties and responsibilities in a sound manner successfully and distinctly. whenever there is confidence in the guidance from the parties of the psychological services process and colleagues, they can increase creativity and excellence in their work, improve performance and job satisfaction, and increase the ability of the psychological service provider to respond to environmental and societal changes. empowering the psychological service provider in their psychological services process requires four basic skills: psychological services offer specialised help provided by a trained person to another person who needs it either to solve a problem or to develop their abilities and invest their optimal development. therefore, the psychological service provider must have problemsolving skills, but given the importance of these skills in their work, psychological service providers must receive training to increase their ability to solve the problem with sound scientific steps from the collection of information and also identify alternatives and choose the best option to solve the problem. this skill increases the confidence of the psychological service provider, and it achieves a high level of satisfaction with the performance of the client in solving their problem, which contributes to the empowerment of the professional provider and their ability to make decisions during the psychological services process and increase the level of personal satisfaction with the performance of their psychological service work. the self-awareness of the psychological service provider means understanding and accepting it in a peaceful manner, managing it efficiently and then developing its potentials and making the best use of them. the more self-awareness they have, the more the powerfully and personally they will do the job. self-awareness skills refer to those skills that help the psychological service provider to know the strengths and weaknesses of their personality. it also includes the psychological service provider's knowledge of their personal rights, professional obligations and duties towards their profession and clients, and what they want to achieve from their work and from life in general. there is no doubt that this skill, if available to the psychological service provider and covered in training to increase their professional and personal empowerment, gives them the ability to make decisions. if the psychological service provider lacks sufficient self-awareness, they behave without full consciousness, and they will miss the knowledge of the consequences of the decisions they make, and thus be exposed to many mistakes that they could have remedied if they had enough self-awareness. these are necessary skills needed by the psychological service provider during their professional practice, and attempts to solve the problem of the client; it must not rush the results of psychological services and not rush to choose between alternatives to solve the problem of the client; and the choice between methods and techniques must be carefully chosen according to the nature of the client problem and the integrated diagnosis of them and the nature of their personality. because psychological services work is hard and painstaking, the psychological service provider is in urgent need to persevere in order to achieve professional empowerment in their professional practice, and to reach the level of creative professional behaviour, not just traditional. there is nothing else that can play this role, since perseverance is the key to success and the basis of effectiveness and efficiency. communication skills are a set of skills that an individual needs in their daily dealings, through which an individual can convey his or her thoughts, attitudes, values and feelings to others either verbally or in writing or through body language and facial gestures. communication skills are essential skills in psychological services work. psychological services is a face-to-face communication process, in which specialised assistance is provided to a person with a problem. therefore, if a psychological service provider wants to do their job well and be successful, they must have communication skills and receive training in them because this makes them skilled in their work and able to perform their duties and responsibilities towards the psychological service providers. effective communication skills help the psychological service provider to achieve their planned aims, as well as strengthen the relationship between the parties of the psychological services process through increased understanding and empathy. it can be said that % of the success in the psychological services work is due to mastery of communication skills and psychological services skills, and only % of it is attributed to science and specialised knowledge. undoubtedly, the community's efforts to seek psychological ser- the statistical population of this study includes all psychological service providers. from this population, a random sample consisting of psychological service providers ( males and females) was selected, with an age range of between and years. participants were first informed about the aims and the content of the study. then, they were assured about the confidentiality of their answers. they were asked to check a box if they agreed to participate in this study. institutional review board approval was obtained, and participants' informed consent in this study was secured prior to data collection. the study applied a descriptive method to test the psychometric properties of a statistical psychological service providers' empowerment scale. participants completed the psychological service providers' empowerment scale (pspes- ). all analyses were performed with spss . (statistics package for the social sciences) and amos (v. ) by maximum likelihood method to evaluate the measurement modelling proposed by psychological service providers' empowerment and test the validity and reliability of the scale prepared in this study. the self-report psychological service providers' empowerment scale was prepared by the researcher, and consists of items distributed on seven dimensions (see table ): the first dimension is expect psychological services effectiveness, consisting of six items ( , , , , and ), the second dimension is self-stimulation, consisting of six items ( , , , , and ) , the third dimension is responsibilities and duties, consisting of three items ( , and ), the fourth dimension is psychological services work environment, consisting of three items ( , and ) , the fifth dimension is psychological service providers' decision-making, consisting of three items ( , , ), the sixth dimension is creative psychological service provider behaviour, consisting of three items ( , and ), and the seventh dimension is psychological services confidence, consisting of four items ( , , and ). the individual responds with a -point likert scale (fully agree = to not fully agree = ). the present study aimed to test the psychometric properties of a psychological service providers' empowerment scale and evaluate the proposed measurement modelling to predict psychological service providers' empowerment. the reliability of the scale was assessed on the study sample. regarding internal consistency, the correlation coefficients of the items with seven dimensions of the scale (see table ), and the correlation coefficients between the seven dimensions and the total score (see table ) were . , . , . , . , . , . , and . , respectively. the cronbach's alpha values for dimensions and for the scale as a whole (see table ) were α = . , the principal components analysis (pca) method was used to derive psychological service providers' empowerment factors. the factor was also considered if the value of the underlying root eigenvalue was correct and the expression was capped at . or higher, according to the kaiser test as a minimum for the acceptance of the factor, and the items with the lowest determinations were excluded (see figure ). in accordance with these determinants, the exploratory analysis produced seven factors that accounted for . % of the total variance of the scale. the results are shown in tables and . it is clear from the results shown in two tables and that the subcomponents of the psychological service providers' empowerment scale are saturated on seven factors, which explained . % of the total variation of psychological service providers' empowerment, so that the proposed model of psychological service providers' empowerment and the theoretical basis of the scale are fully matched. in order to find how the seven factors of empowerment relate to produce an overall measure of empowerment among psychological service providers' empowerment, a empowerment model was designed (see figure ). to confirm that the theoretical structure of the scale has goodness-of-fit and to test hypotheses about the relationship between certain variables belonging to common hypothesis factors, a confirmatory factor analysis was used by maximum likelihood method, assuming that the subcomponents saturate on only seven factors. the results of the exploratory factor analysis are as follows: . expect psychological services effectiveness factor: saturated on four measured indicators (c , c , c , c , c , c ). . self-stimulation: saturated on four measured indicators (c , c , c , c , c , c ). . responsibilities and duties: saturated on four measured indicators (c , c , c ). . psychological services work environment: saturated on four measured indicators (c , c , c ). four measured indicators (c , c , c ). . creative psychological service provider behaviour: saturated on four measured indicators (c , c , c ). . psychological services confidence: saturated on four measured indicators (c , c , c , c ). the measurement components of the model are designed to ensure the accuracy of the measurement of the latent variables of the model. in this model, as seen in figure , ellipses represent latent variables, and rectangles represent measured variables. figure illustrates we should identify the implications of these indicators on the factors to which they belong. figure shows that the indications of items range from . to . for the expect psychological services effectiveness factor, from . to . for self-stimulation, from . to . for the responsibilities and duties factor, from . to . for the psychological services work environment factor, from . to . for the psychological service providers' decision-making factor, from . to . for the creative psychological service provider behaviour, and from . to . for the psychological services confidence factor (see figure ). the present study applied sem, an advanced statistical method, to test the construct validity of the psychological service providers' empowerment scale. the exploratory factor analysis was used to demonstrate a more realistic representation of the relationship between the items and factors. the seven factors modelling the psychological service providers' empowerment scale were confirmed, which means that we can predict psychological service providers' empowerment from these seven factors. the study that was conducted by sürücü and besen ( ) showed that we can predict empowerment of type diabetic individuals from education about diabetes, high school, university, age, social support and employment status; these variables were statistically significant predictors. in addition, the study of wallach and mueller ( ) spreitzer, ; thomas & velthouse, ; zimmerman, ) . the factorial structure of the scale prepared by the researcher showed a great compatibility between the theoretical aspect of the scale and the analysis data obtained from the study sample, and this increases the confidence in the ability of the scale to measure psychological service providers' empowerment and also indicates that the scale has the implications of internal consistency. the covid- pandemic crisis and the stresses associated with quarantine and social distancing have increased the need for specialists in psychological counselling and psychotherapy and those responsible for psychological service centres to prepare and plan counselling and psychological therapy programmes via the internet for community members who suffer from symptoms of mental disorders resulting from the increasing outbreak of covid- , and provide psychological services to patients with covid- to increase their coping skills and to recover from serious physical and psychological symptoms (arnout, al-dabbagh, et al., ) . thus, the spread of the covid- pandemic increases the continuous professional burdens or stresses of psychological service providers, causing pressure that affects the quality of their performance, resulting in them requiring professional assistance to enable them to do their work. this is confirmed by barnett et al.'s ( ) findings that continued work stresses affect helping professionals' mental health and leads to burnout and other stress-related disorders. from the findings of this study, we can predict psychological service providers' empowerment from seven factors. therefore, we recommend looking at ways to increase psychological service providers' f i g u r e standard path parameters of the measurement component of the proposed model for psychological service providers' empowerment [colour figure can be viewed at wileyonlinelibrary.com] empowerment, which requires his or her skilful empowerment, that is gaining and developing their skills in psychological services work on the one hand, as well as empowering them in managing psychological services work with clients and the freedom to choose psychological services methods and techniques, planning the psychological services process and recognising that they have the ability to influence the clients, which improves job satisfaction, encouraging them to respond quickly to guide the needs of clients, solve their problems and work in positive ways, and create a climate of trust between psychological service providers and clients. we can list the benefits of empowering a psychological service provider in their work as follows: . increase creative psychological services practice. . ability to make decisions related to the psychological services process. . effective participation of the psychological service providers and the ability to influence the psychological services process and co-workers. . increase the ability to solve problems that they may face during their work. . increase job satisfaction and psychological services confidence. . raise the level of satisfaction of the beneficiaries of the psychological services provided to them. . performance excellence and take risks effectively. . the high level of psychological services provided to clients. . abandon the traditional methods of professional practice. . professional, moral and community commitment. psychological service providers' empowerment can lead to a sense of belonging, satisfaction in their profession of psychological services, perception of the importance of their work in providing assistance to clients, increase in their responsibility towards them and the direction of the profession and active participation in the development of their professional performance, as a result of their psychological, cognitive and professional empowerment at the physical, sensory or moral level. this enables them to achieve the objectives of the psychological services process and the personal aims of the clients, and even the profession of psychological services and the organisation in which they work, as a result of providing the conditions that make them able to accomplish the responsibilities of their job. in the light of this study's results, we need future studies on psychological service providers' empowerment, as there are no studies dealing with this variable by investigation and analysis. in addition, the results of this study will direct the future studies to develop programmes to increase empowerment among psychological service providers according to the seven factor model proposed, which was tested in this study. the authors would like to express their gratitude to king khalid university, saudi arabia, for providing administrative and technical support. the author of this manuscript declared that they have no conflict of interests. the author of this manuscript has complied with ethical principles in their treatment of individuals participating in the research policy described in the manuscript. all data underpin this study found in this manuscript, and there are no any additional data. boshra a. arnout https://orcid.org/ - - - religiosity, psychological resilience and mental health among breast cancer patients in kingdom of saudi arabia leader's spiritual intelligence and religiousness: skills, factors affecting, and their effects on performance (a qualitative study by grounded theory) psychological empowerment and life orientation among a sample of primary stage teachers exploring the experiences of healthcare providers who survived mers-cov in saudi arabia enjoying life and health status among young adults and elderly: a comparative study in light of the globalization effects on the human being of the st century the integrated encyclopedia of psychological services and psychotherapy a structural equation model relating unemployment stress, spiritual intelligence and mental health components: mediators of coping mechanism covid- pandemic crisis: and the new face of the world the effects of corona virus (covid- ) outbreak on the individuals' mental health and on the decision-makers: a comparative epidemiological study a structural model relating gratitude, resilience, psychological well-being and creativity among psychological counsellors a structural equation modeling analysis of marital bullying scale diagnostic criteria for post-bullying disorder (pbd): a phenomenological research design of bullying victims empowering service employees ten characteristics of empowerment-oriented social service organizations an investigation of the relationships among employee empowerment, employee perceived service quality, and employee job satisfaction in a u.s. hospitality organization an assessment of ebola-related stigma and its association with informal healthcare utilization among ebola survivors in sierra leone: a cross-sectional study. l the impact of using the strategy of empowering workers on achieving job satisfaction within the institutions recent trends in measuring psychological empowerment engaged, committed and helpful employees: the role of psychological empowerment employee empowerment: an integrative psychological approach stigma and ebola survivorship in liberia: results from a longitudinal cohort study the drivers of employee engagement psychological empowerment in the workplace: dimensions, measurement, and validation predictors of empowerment in individuals with type diabetes mellitus cognitive elements of empowerment: an "interpretive" model of intrinsic task motivation job characteristics and organizational predictors of psychological empowerment among paraprofessionals within human service organizations: an exploratory study psychological empowerment: issues and illustrations key: cord- - o m si authors: fusco, floriana; marsilio, marta; guglielmetti, chiara title: co-production in health policy and management: a comprehensive bibliometric review date: - - journal: bmc health serv res doi: . /s - - - sha: doc_id: cord_uid: o m si background: due to an increasingly elderly population, a higher incidence of chronic diseases and higher expectations regarding public service provision, healthcare services are under increasing strain to cut costs while maintaining quality. the importance of promoting systems of co-produced health between stakeholders has gained considerable traction both in the literature and in public sector policy debates. this study provides a comprehensive map of the extant literature and identifies the main themes and future research needs. methods: a quantitative bibliometric analysis was carried out consisting of a performance analysis, science mapping, and a scientific collaboration analysis. web of science (wos) was chosen to extract the dataset; the search was refined by language, i.e. english, and type of publication, i.e. journal academic articles and reviews. no time limitation was selected. results: the dataset is made up of papers ranging from to may . the analysis highlighted an annual percentage growth rate in the topic of co-production of about %. the articles retrieved are split between authors and sources. this fragmentation was confirmed by the collaboration analysis, which revealed very few long-lasting collaborations. the scientific production is geographically polarised within the eu and anglo-saxon countries, with the united kingdom playing a central role. the intellectual structure consists of three main areas: public administration and management, service management and knowledge translation literature. the co-word analysis confirms the relatively low scientific maturity of co-production applied to health services. it shows few well-developed and central terms, which refer to traditional areas of co-production (e.g. public health, social care), and some emerging themes related to social and health phenomena (e.g. the elderly and chronic diseases), the use of technologies, and the recent patient-centred approach to care (patient involvement/engagement). conclusions: the field is still far from being mature. empirical practices, especially regarding co-delivery and co-management as well as the evaluation of their real impacts on providers and on patients are lacking and should be more widely investigated. co-production in public services has become the leitmotif of public policy reform [ ] [ ] [ ] . it is considered a potential solution to the current and future challenges in the public sector, given that the expected benefits concern the improvement of the services provided, a greater economic and financial sustainability of the system, the more efficient use of resources, and the possibility of increasing the satisfaction level of citizens [ , ] . despite this growing interest, co-production is still a nebulous concept, a "woolly-word" in the field of public policy [ [ ] : ], a "quite heterogeneous umbrella concept" [ [ ] : ], with a wide range of definitions [ ] . in , ostrom [[ ] : ] defined it as "the processes through which inputs, used to provide a good or a service, are contributed by individuals who are not in the same organization". this definition was subsequently interpreted in different ways, considering only the involvement of the users [ ] or of any individual or entity external to the organisation [ ] . there is some agreement that it covers the practices in which state actors (i.e. government agents serving in a professional capacity) and lay actors (i.e. members of the public, serving voluntarily as citizens or users) work together in any phase of the public service cycle (i.e. commissioning, design, delivery, and assessment) [ , ] . co-production implies that citizens are not merely recipients of services, but can act as co-producers in the design and the delivery of public services [ ] . of the various contexts of application, the literature seems to agree that the health sector is a reference point where the concepts of co-production can be analysed and put into practice [ , [ ] [ ] [ ] [ ] [ ] [ ] . it is a sector where resources are being reduced and where there are increasing concerns about long-term economic sustainability. on the other hand, there are expectations of higher quality as well as a growing demand caused above all by an aging population and the rise in chronic diseases. this is forcing healthcare policymakers and managers to reduce healthcare costs (e.g. by reducing the length of hospital stays and readmission rates), and at the same time, improve the quality of the service and, more generally, the patients' quality of life [ ] . patient engagement has become imperative in delivering high quality healthcare services [ ] . this more active role of patients has transformed public service production: patients are asked to participate actively and act as consumer producers, next to and in interaction with healthcare professionals and other decision-makers in healthcare, such as policy makers [ , ] . the pressure to create co-produced health services is increasing, and the debate is wide open on the nature of co-production, on how healthcare practices change in order to manage effective partnerships between clients and professionals and on the impacts of trying to optimise health outcomes. despite the growing interest and the consequent increase in the number of publications on co-production in the healthcare sector [ ] , there is a lack of studies that provide a comprehensive picture of the structure and the development of this field. some co-production qualitative literature reviews have already been carried out. only one specifically targeted the healthcare sector [ ] ; others have investigated the broader context of public services [ , ] . all of them have focused on specific research questions (such as the aims, drivers/barriers and outcomes), but do not provide an overall and comprehensive picture of the healthcare co-production research field. this paper aims to fill this gap with a quantitative bibliometric analysis on co-production in the healthcare sector. a quantitative review enhances the understanding of this research field and further informs the scientific debate on this topic. specifically, using the main procedures of the bibliometric method (performance analysis, scientific collaboration analysis and science mapping), the work aims to i) quantify the research field and describe its main outputs and evolution; ii) analyse the collaboration practices and map the social structure of the field; iii) define the intellectual structure and understand the main conceptualizations and theoretical approaches; iv) identify the most investigated themes and propose future avenues for research. bibliometric analysis has been increasingly used both in social sciences [e.g. [ ] [ ] [ ] [ ] ]; and with specific reference to the health field [e.g. [ ] [ ] [ ] ], and medical science [e.g. [ , ] ]. it is based on the statistical measurement of science, scientists, or scientific activity and it is, therefore, considered a more objective and reproducible method with which to develop a review process compared to other techniques [ , ] . the process of data collection and data analysis is detailed below. data were retrieved from the web of science (wos), and specifically from the science citation index expanded (sci expanded) and the social science citation index (ssci) [ , ] . the search criteria were "co-production and health* or coproduction and health*" in the string "topic" (that is title, abstract and keywords). the search did not include correlated words, such as engagement, involvement and co-creation, given that these are different concepts from co-production, although strictly linked to it [ ] . the query was launched on may and resulted in the retrieval of documents. the search was then refined by language (english) and document type (article and review) [ ] . although coproduction first appeared in the s, it has begun to receive particular attention in recent years. no limitation time was selected in order to gather the evolution over time since its first appearance in literature. the filtering stage produced documents. to avoid including papers that were not related to the topic, i.e. not containing the concept of co-production (as defined above), and/or not referring to the health field, the collection was screened in terms of titles and abstracts. the excluded papers focused on microbiology, biochemistry, pharmacology, environmental science and ecology. this phase was first carried out by one author, and then checked by two other authors and any discrepancies in the evaluation were discussed. this screening thus reduced the risk of including unrelated articles or, conversely, excluding pertinent ones. the final sample is made up of documents (see additional file ). figure summarizes the research design. bibliometric techniques are based on the analysis of bibliographic attributesalso called "metadata" -of a document, such as authors, citations, collaboration, keywords, in order to have insights into a scientific field's structure, social networks and relevant themes [ , ] . in the present study, the bibliometric analysis was carried out using bibliometrix, a free open source software application, supported by the r environment, which provides a set of tools for quantitative research in bibliometrics and scientometrics [ ] . on the basis of the final sample retrieved by wos in bibtex format, data were loaded and converted into r dataframe in bibliometrix, in order to develop three main level of analysis: i) performance analysis; ii) collaboration analysis; and iii) science mapping. a performance analysis highlights the sample characteristics and measures its main performances by quantifying the research field (the number of published documents, the number of received citations), identifying the most important (most cited, most productive, etc) actors, and evaluating groups of scientific actors (countries, universities, departments, researchers) and the impact of their activity [ ] [ ] [ ] [ ] . at this stage, a citation analysis was also performed. a citation analysis is based on the hypothesis that authors cite documents considered most important in the development of their research. frequently cited studies are expected to have a greater influence on the research field than those less frequently cited [ , ] . to ensure the accuracy of the data, the references were checked to ensure that they were written in the same way in all the documents. a scientific collaboration analysis was then carried out in order to highlight the most relevant relations between the actors (i.e. authors and countries) [ ] [ ] [ ] [ ] . scientific collaboration analysis is widely used in different strands of research [e.g. [ , ] ] in order to identify the social structure of the field. this is achieved via a social network analysis where the network's nodes are the authors, their institution or country to which the institutions belong, and the edges (links) are established according to the nodes who co-authored an article. the science mapping was performed through a cocitation analysis and co-word analysis. science mapping "is a spatial representation of how disciplines, fields, specialities, and individual papers or authors are related to one another" [ [ ] : ]. the co-citation analysis was used to capture the intellectual structure of the field. co-citation is defined as the frequency with which two documents are cited together in the literature and it assumes that documents are co-cited if they are conceptually close [ ] [ ] [ ] . given that it is a dynamic approach, it is often considered to be preferable to bibliographic coupling, which occurs when two documents have at least one reference in common. its validity as a tool for exploring the intellectual structure of a scientific field has been stated in numerous studies [e.g. [ , ] ], and it is increasingly being used in all disciplines, including in the management field [e.g. [ , , ] ]. in the clustering derived from this analysis, the network nodes represent cited documents, whose size depends on the number of citations. the edges represent the co-citation relationship and their weights depend on the number of times that two documents have been cited jointly [ ] [ ] [ ] . in this bibliometric analysis, a minimum degree of co-citation (equal to ) has been set and a threshold of network nodes has been considered. these settings ensure the clarity of the network, without compromising the validity of the results that did not have relevant deviations by increasing the size of the network. a co-word analysis is based on the idea that the cooccurrence of key terms (i.e. abstract, title or keywords) describes the content of the documents [ ] . this technique identifies and visualises clusters that represent semantic or conceptual groups of different topics treated in the research field. using the approach developed by cobo et al. [ , ] , the thematic clusters are visualised in a "strategic diagram" or map. moreover, the authors read the abstracts or full-text of papers when necessary to add relevant information to the results of the quantitative bibliometric analysis (e.g. in "performance analysis" to add the methodological approach and main content of most cited papers and references; in "co-citation analysis" to know the main contents of most important nodes and discuss the clusters). in the additional file the data (i.e. papers of the sample) and metadata (e.g. authors, citations, etc.) used in each analysis' stage are detailed. the articles of the sample have been published from to (table ) . this research field is fairly recent with an annual scientific growth rate of nearly %. as shown in fig. , the biggest increase has occurred in the last years (about % of documents sourced); in the number of publications was more than double compared to , and more than quadruple compared to . authorship is very fragmented, with authors and a collaboration index (i.e. a co-authors per article index calculated only using the multi-authored article set) of . . there is an average of . authors per document; only a few documents were written by one single author ( articles, . %). there is an average of . documents per author, and only ( . %) of authors have published more than three works, and ( . %) that have published more than two works. the most productive authors (additional file ) tend to be academics in medicine and nursing, with a lower incidence in psychology, social informatics and management. the articles in the dataset were published in journals, only of which ( . %) have published more than three articles and ( %) more than two articles, with a mean of . article per journal. the most productive journals represent approximately % of the total number of documents retrieved; they belong to different areas of researchincluding medicine, management, business, social science -with nearly all in health fields according to wos categories ( table ). the top two journals cover the health field (i.e bmj open) and the public sector (i.e public management review). the geographical distribution of papersbased on all authors' affiliations -is concentrated in anglo-saxon countries (uk, usa, australia, canada and ireland) and in other european countries (netherlands, sweden, denmark, italy, finland and norway) (fig. ). the uk is the most productive country, where patient involvement in clinical practices has been a priority since the s and new forms of organisation and delivery of healthcare services have been promoted by the nhs since the early s [ , [ ] [ ] [ ] . table shows the top manuscripts per total citation, the first of which was published in , when the scientific interest in the topic really began to take hold. the article with the highest number of total citations is the work by mccoll-kennedy et al. in [ ] , followed by the one written in by voorberg et al. [ ] ) and by carayon in [ ] ). the ranking changes slightly if annual citations are considered, i.e. the average number of citations received per year. these top ranked articles consist of four conceptual papers, two reviews and four empirical papers. interestingly, the empirical studies tend to try to develop theoretical or conceptual models/findings from the results: three adopt qualitative methods (i.e. the papers by mccoll-kennedy et al. [ ] ; gillard et al. [ ] ; mort et al. [ ] ) and one quantitative method (i.e. the work by trummer et al. [ ] ). in these top ten papers, there is no homogeneity regarding the clinical field on which the study sample focused. furthermore, one of the two reviews [ ] is qualitative, i.e. a structured systematic review, the other uses a mixed method [ ] . four of the papers were published in health journals, followed by three in public administration and management and one in business, ergonomics and environmental sciences journals. it is not possible to identify reference theories for all ten papers, but four explicitly fit into the public management and administration literature, i.e. the works by osborne et al. [ ] , by batalden et al. [ ] , ; vooberg et al. [ ] and dunston et al. [ ] ); the work of mccoll-kennedy et al. [ ] refers to service management theories and the work of gillard et al. [ ] refers to gittell's theory on relational coordination. two studies focus specifically on the co-production of knowledge [ , ] . the top ten cited references (table ) are mainly coproduction seminal works in the field of public services. only two works, those by dunston et al. [ ] and by batalden et al. [ ] refer specifically to the health sector. the most cited works are the conceptual framework developed by bovaird in [ ] , which is considered a milestone on co-production topic in public management, and the seminal work by ostrom et al. in [ ] . this analysis provides an overview of the scientific collaboration and research communities, with reference to different aggregation levels [ ] . in this study, countries and authors were considered as units of analysis. the first analysis focused on cross-country collaboration (fig. ) . the network has its central and most important node in the uk (betweenness centrality = . ); the other top nodes are the usa, australia, canada and the netherlands. the results are not totally surprising given the scientific production of each country highlighted in the performance analysis. however, further comments can be made regarding the multiple-country collaboration ratio of the top ten countries per publications i.e. the ratio between the number of multi-country collaborations and the total number of papers attributed based on the affiliation of the corresponding author ( table ). the uk has the highest number of cross-country collaborations ( multi-country collaborations), yet the uk's multicountry publication (mcp) rate is only . %, much lower than the ratios of australia ( %), usa ( %) and italy ( . %). in order to understand any long-lasting collaborations among authors, the co-authorship network (fig. ) excluded one-shot collaborations (min.edge = ). only out of authors, appeared to have collaborated with the same research group more than once, and they are clustered into twelve groups (see additional file ). the clusters are characterised by differences in the disciplinary and professional background of the authors, geographical affiliation and research focus of the coauthors' work. group is the biggest and densest. it is made up of an academic cross-national network between australian, new zealand and northern european authors with a research focus on patient co-production in mental health. group is a cross national authors' network in europe (i.e. italy, finland, denmark, the netherlands, romania), focused on public health and policy. group is composed of an interdisciplinary group of psychology, primary care and social informatics researchers, all with uk affiliation and focused on coproduction in assisted-living technologies. group is geographically limited to the uk, it includes both academics and practitioners and it is characterised by the research interest on patient co-production in mental health. . groups and share the same focus on public health and policy, but they have a different country's affiliation. group is composed by australian affiliation authors, group by uk affiliation authors. groups focuses on knowledge translation and is made up academic authors with uk affiliation. the same geographical characteristic can be found in group , but the scientific focus is on health safety issues. group is made up of primary care and nursing academics, with uk affiliation, specialised in dementia, comorbidity, integrated care and continuity of care for older people with complex health needs. group refers to australian academics and practitioners with an interest in research and evaluation in mental health. group is composed by academics with an australian university affiliation and a focus on service development and citizen participation in rural health. group is made up of authors affiliated with universities in the uk in the field of co-production in medical education. the intellectual structure of the field: co-citation analysis intellectual structure is defined as "the examined scientific domain's research traditions, their disciplinary composition, influential research topics and the pattern of their interrelationships. these publications are the foundations upon which current research is being carried out and contain fundamental theories, breakthrough early works and methodological canons of the field" [ [ ] : ]. intellectual structure is investigated through a cocitation analysis which verifies the presence and frequency of the co-citations in a dataset and identifies which clusters of citations are conceptually related and how relevant they are [ , ] . the co-citation analysis ( fig. and additional file ) was carried out with a minimum degree of co-citation equal to and a threshold of network nodes. this was designed on the basis of the number of papers and the fragmentation of the field as well as to ensure the the findings show a network whose most central and important nodes are represented by "bovaird t - " (betweenness centrality = . ) [ ] and "ostrom e " (betweenness centrality = . ) [ ] , that are also the two most cited documents in the database (see also the above table ). the study by bovaird [ ] was one of the first to report a conceptual framework of coproduction. co-production is described as a "revolutionary concept in public service" [ [ ] : ] and the framework maps the various interactions that can be established among public providers, service users and their communities. it identifies the various stages where co-production can take place: planning, design, commissioning, management, delivery, monitoring, and evaluation. bovaird also provides some case studies that give insights into the benefits and challenges of coproduction. using an institutional-economic approach, ostrom [ ] analyses co-production as a way to overcome the divide identified between "a market-based logic of development and the traditional theories of public administration" [ [ ] : ]. her two case studies suggest that co-production into polycentric and synergic systems between government agencies and citizens is crucial in order to reach higher levels of welfare in developing countries. the co-citation analysis revealed three main clusters. a: "public administration and management". this is the largest group ( works) with the densest ties and the most top nodes in the entire network. seminal and early contributions are represented by "parks rb " [ ] , "whitaker gp " [ ] and "ostrom e " [ ] . the cluster includes some political science and economics studies [e.g. [ , ] ] and a predominance of public administration and management works [e.g. [ , ] ]. these studies consider co-production as a tool of public policy aimed at improving the efficiency and effectiveness of public services. "coproduction is one way that synergy between what a government does and what citizens do can occur." [[ ] : ]. the prevailing approach is top-down, strongly focused on the public service provider. co-production is seen as something "to be consciously built into public services" [ [ ] :s ] and thus the discussion is centred on "the ways in which service user participation can be 'added into' the process of service planning and production" [ [ ] :s ]. three types of possible co-producers are identified in the public service regime (clients, citizens and volunteers) and differences with co-production in the private sector are discussed [ , ] . the papers in this cluster detail the conceptualization of co-production in the public sector, analyse its pros and cons, as well as how its implementation can be incentivised and managed. seven of these specifically investigate the health sector, seen as a key area for the implementation of co-production practices [e.g. [ , , ] ]. co-production is seen as a promising tool for dealing with challenges in the sector such as increasing and changing demands with a simultaneous decrease in resources [ ] . the number of elderly people, with multifaceted needs and high expectations, as well as the rates of chronic diseases are growing [ , ] . this puts the onus on healthcare systems to contain costs without detracting from the high quality of care. rising hospitalization costs are forcing healthcare administrators to reduce the length of hospital stays and the readmission rate, making it necessary to build relational models in which the patient feels part of the healthcare team and willing and able to continue self-care after discharge. co-production can help to ensure both the improvement in the service and sustainability in the system [ ] , taking into account possible limitations and challenges [ ] . b: "service management". this consists of eight documents from the service management and marketing literature. in this cluster there is little crossover with other disciplines. in terms of service management, these works focus on the (co-)creation of value for/with the customers/users. the internal top nodes are represented by "vargo sl - " [ ] , "vargo stephen " [ ] , and "bendapudi n " [ ] . from this perspective, organisations consider customers as an important resource, quasi-employees, who carry out part of the service delivery. this concept of customer participation then leads to a service-dominant (s-d) approach where service is the common denominator in exchange, and within its delivery, the customer is a co-creator of value both for the firm and her/himself [ , , ] . from this perspective, some studies refer to a specific topic, such as customer behaviours, practices and psychological implications [e.g. , ] . given these theoretical assumptions, scholars point out that service management and a marketing perspective have much to offer the analysis and interpretation of a "critically important and intellectually healthcare is considered a fertile field for empirical research, given that "no other service sector affects the quality of life more than health care. no other service commands more resources or is more challenged as it faces the future" [ [ ] : ]. in line with the focus of this cluster on service management rather than on the public domain, the studies refer to private healthcare organisations [ , , ] . the visual representation of the co-citation network shows the presence of numerous ties and bridges-nodes (connecting nodes between two clusters), that are "osborne sp - " [ ] , "osborne sp - " [ ] ; "hardyman w " [ ] between the two clusters. in fact, there has recently been a crossover between public management and service management in studies that discuss how the public management literature can benefit from the service paradigm, for example in the development of a public service-dominant approach [ , , ] or the work on the co-creation of public value [ ] . c: "co-production of knowledge". this cluster has fewer internal and external ties. the cluster focuses on the coproduction of knowledge in its specific meaning of knowledge translation between researchers and decisionmakers (clinicians, managers, policy-makers, etc.) "for the purpose of engaging in a mutually beneficial research project or program of research to support decisionmaking" [[ ]: ]. the user's or patient's perspective is, therefore, almost neglected, with the partial exception of "greenhalgh t - " [ ] , who focus on communityacademic partnerships. the top nodes are represented by "gagliardi ar - " [ ] and "graham id " [ ] , which are both literature reviews as well as most of the other works in cluster. moreover, unlike the other clusters, six out of the nine studies are specifically on the health sector. a co-word analysis of author keywords (min. frequency = ; number of words = ) helps to define a map of the main themes of the field. in order to avoid deviant results, the dataset was screened before being submitted to analysis by the software. generic keywords inserted in the search query were eliminated (i.e. coproduction; co-production; health); ii) the spelling of keywords was harmonized (e.g., plural or singular; american or english style; with hyphen or without hyphen). using the visualization technique proposed by cobo et al. [ , ] , a strategic thematic map was developed, plotting the themes into four quadrants (clusters of keywords) according to their centrality and density rank values along two axes. the centrality measures the degree of interaction of a network with other networks and is considered "as a measure of the importance of a theme in the development of the entire research field analysed." [[ ] : ]. the density measures the internal strength of the network and identifies the degree of development of a theme. the size of the cluster is given by the number of occurrences of the keywords that it contains and therefore by the number of linked papers. the label chosen by the software corresponds to the predominant keyword (fig. ) . for each quadrant, clusters with a higher number of related papers are discussed. motor themes (first quadrant): these are well developed themes that are key to the structure of the research field, and are characterized by high centrality and high density. there were few "motor" themes -"public health", "social care" and "codesign" -and they are at the axis of the fourth quadrant. social care mainly refers to the coproduction and personalisation of community health and the delivery of well-being services [ ] . the focus is above all on the weakest segments of the community or on integration difficulties [ , ] . confirming the evidence on collaboration among authors, "public health" is one of the most explored fields, both in terms of the co-production of knowledge [ , ] and service design and/or delivery [ , ] . "co-design" is a specific phase of co-production referring to activities that involve "the experience of users and their communities" into the creation, planning, or arrangements of public services [ [ ] : ]. examples of co-design in our dataset were related to the improvement of hospital services [ ] , public health [ ] , integrated care [ ] , and assistive technology [ ] . niche themes (second quadrant): these are well developed and very specialised themes, but marginal in the overall field. "knowledge translation" appears to be a most recurrent theme in this quadrant. its internal specialization and external marginality were evident also in the intellectual structure (i.e. cluster "co-production of knowledge"), where it was scarcely connected with other clusters. knowledge translation concerns the partnership between researchers and practitioners-decision makers aimed at reducing the gap between research and practice [ , ] . the concept of "empowerment" is strictly related to co-production [ ] , and relates to patient self-confidence and the understanding of their role. some authors considered empowerment as a determinant of co-production, given that co-production requires "that a degree of confidence exists for any patient to feel sufficiently empowered to actively engage." [[ ] : ]. others argue that it is engagement and co-production that boost empowerment because they increase confidence and give users a sense of influence or control [ ] . the theme "quality improvement" focuses on the improvement of health services, which is achieved primarily through coproduction and personalisation of patient care [ , ] . the "nursing" cluster highlights the recognition of the importance of the role of nurses in health service delivery, thanks to their closeness to endusers and the role played by patients (experts by experience) in improving nursing education and training [ ] . peripheral themes (third quadrant): this comprises both emerging and declining themes, characterised by low density (under developed) and centrality (marginal). this quadrant includes care for the elderly, who are a critical and weak group in the population in terms of chronicity and comorbidity and therefore with greater health and social care needs [ ] . in this context, there are frequent examples of co-production through technology (e.g. telecare or telehealth), which facilitate the monitoring of the patient's health conditions, the possibility of providing services at home, and the involvement of patients and caregivers in the process of care [ ] . transversal and general, basic themes (fourth quadrant): these are themes with a high centrality and low density, which are important for the coproduction field, but are still not well developed. they mostly concern umbrella themes, such as "user involvement", "patient engagement", which the most recent psychological and organizational literature prefers to the term "empowerment". the term "cocreation" is now very widespread, but not very focused. this quadrant includes papers, whose intellectual structure mainly refers to the managerial field, both public and service, with a strong focus on the patient as the key-actor in the process. two main themes refer to the most relevant health disciplines where co-production has been widely applied. the first is "mental health", both with reference to co-production of knowledge [ ] and services [ ] . several articles investigate the recovery college model, which as an alternative to the traditional clinical model aims to treat and reduce symptoms; it is inspired by the broader principles of mental wellbeing, recovery and co-production [ ] . indeed, in these colleges, the training courses, whose participants are not only patients, but also caregivers and staff, are co-designed and co-delivered by medical personnel and experts by experience, whose contribution is recognized as having a strong impact on the effectiveness of the model [ , ] . the second area is "primary care" which covers studies referring to the management of long-term conditions, where co-production and self-management become necessary both for health providers and patients and their caregivers [ , ] . moreover, the presence of "evaluation" as a theme highlights that it is considered central for the overall understanding of the co-production practices. several papers have reported the potential of the co-delivery of healthcare services, e.g., peer support groups, nurse-family partnerships [ , [ ] [ ] [ ] . nevertheless, evidence of a clear link to correlate co-production to greater benefits for those involved is, at best, weak [ ] . when explored, the impact is measured through subjective methods, such as satisfaction questionnaires or interviews with patients, staff or caregivers [ , ] . this bibliometric analysis provides a comprehensive picture of the structure and the development of coproduction in the healthcare sector. although there have been some valuable qualitative reviews [ ] , to the best of our knowledge this is the first study to use a quantitative approach and cover the most recent published literature. the analysis shows that academic interest in co-production has increased considerably with an annual growth rate of nearly %: publications increased four-fold between and (almost articles were included in the current analysis, compared to in a previous review). despite this fast-growing interest in co-production in healthcare, the field is still very fragmented. the articles retrieved are split between authors and sources, of which only . % of authors and % of journals have published more than two works. the top authors mainly belong to the area of medicine and nursing, with a lower incidence of other specialisations (psychology, social informatics and management). this fragmentation is also highlighted by the collaboration analysis, which shows very few long-lasting collaborations. authors collaborate frequently (with an average of . authors per document), but generally only once. the field appears to be concentrated in the eu and anglo-saxon countries, with an absolutely central role of the united kingdom, as shown by the performance analysis as well as the collaboration analysis. although the uk has the highest productivity rate, the collaborations are mostly with other authors located in the uk. the proliferation of co-production research in these countries could be justified by the fact that they were early adopters of patient involvement clinical practices and there is also a strong commitment to co-production by the government and the nhs, in order to cut costs and improve the efficiency of public services [ , , , ] . the intellectual structure of health co-production consists of two main subfields (clusters), i.e. public management and service management perspectives. public services have rarely featured in service management research, which is surprising given the discipline's long intellectual history in the concepts of co-production, value-in-exchange and value-in-use. the co-citation analysis revealed a recent but growing crossflow between the two disciplines. in particular, public management academics have investigated how a service-dominant approach [ , ] and value co-creation [ ] can effectively be applied to explain the dynamics of co-production in public sector. the thematic map developed through the co-word analysis helps to identify the most consolidated themes and to provide evidence on the emerging ones. the analysis found few well-developed and central terms and these tended to refer to traditional areas of coproduction (e.g. public health, social care). this confirms the relative low scientific maturity of co-production applied to health services. on the other hand, the analysis revealed some emerging themes related to social and health phenomena (e.g. the elderly and chronic diseases), the use of technologies, and the recent patient-centred approach to care (patient involvement / engagement). the bibliometric method adopted in this study was very useful for investigating and providing a comprehensive picture of co-production in the health field, especially due to the various techniques used (performance analysis, collaboration analysis and science mapping). nonetheless, the paper has some limitations, mostly concerning the methodological issues adopted. only using "co-production" as keyword in the search clearly produced a smaller dataset than might otherwise have been possible; yet it meant that this concept could be analysed in its narrow meaning in combination with related and similar concepts. although a bibliometric method is objective and reproducible, it also implies a less detailed understanding than qualitative techniques. for example, the citation and co-citation analyses show the most cited references, but do not reveal the reason for the citation. again, the conceptual map highlights the main themes, but does not allow for an in-depth analysis of the contents of each paper. the results help to identify avenues for future research. while the branch of knowledge co-production and service co-design (hence the user's participation in the research phase) seems to be more developed in terms of empirical evidence, the research on co-delivery and co-management still seems to be in an embryonic and more theoretical stage. specifically, little has been produced on how the organisation of health services should change or adapt in order to consider the patient as a partner in designing, monitoring, delivering and evaluating a work practice. even less investigated is the theme of the impact of co-production on providers and on patients. the few theoretical studies and even fewer empirical studies on this topic adopt predominantly a mono-dimensional and a mono-stakeholder approach. specifically, psychological-social impacts are assessed, above all in terms of patient satisfaction. besides, even the medical research on home therapy practiceswhich represent a form of "co-production"tends to focus only on the economic and clinical impacts [ ] [ ] [ ] . at present, the presence and the description of co-produced practices is often accepted a priori as a successful output. the implementation of the activity is, therefore, confused with its result or, even if identified, it is based on self-reported data, widely used in management studies, but often applied or reported with little methodological rigor. what does embracing co-production really mean? what value does it create? in what phase can coproduction create the most value? how can this value be measured? future research could try to answer these questions by trying to provide a clearer and unambiguous understanding of the construct (which initiatives should be interpreted as authentic co-production processes?) and what its results are. together for better public services: partnering with citizens and civil society changing public service delivery: learning in co-creation from participation to co-production: widening and deepening the contributions of citizens to public services and outcomes engaging public sector clients: from service-delivery to coproduction a systematic review of co-creation and co-production: embarking on the social innovation journey co-production and the co-creation of value in public services: a suitable case for treatment? co-production: the state of the art in research and the future agenda. volunt int j volunt nonprofit org user co-production of public service delivery: an uncertainty approach crossing the great divide: coproduction, synergy, and development customer, partner: rethinking the place of the public in public management distinguishing different types of coproduction: a conceptual analysis based on the classical definitions varieties of participation in public services: the who, when, and what of coproduction our health, our care, our say: a new direction for community services co-production and health system reform-from re-imagining to re-making co-production in healthcare: moving patient engagement towards a managerial approach contextualizing co-production of health care: a systematic literature review co-production in healthcare: rhetoric and practice health care services and the coproduction puzzle: filling in the blanks the triple aim: care, health, and cost patient engagement as an emerging challenge for healthcare services: mapping the literature experience-based design: from redesigning the system around the patient to co-designing services with the patient citizens and co-production of welfare services: childcare in eight european countries the intellectual structure of research into ppps: a bibliometric analysis foundations and trends in performance management. a twenty-five years bibliometric analysis in business and public administration domains the evolution of sustainability measurement research what is the stock of the situation? a bibliometric analysis on social and environmental accounting research in public sector a bibliometric analysis of health economics articles in the economics literature paucity of qualitative research in general medical and health services and policy research journals: analysis of publication rates intellectual capital in the healthcare sector: a systematic review and critique of the literature bibliometric analysis of severe acute respiratory syndrome-related research in the beginning stage global research output on hiv/aids-related medication adherence from to measuring progress and evolution in science and technology-i: the multiple uses of bibliometric indicators dictionary of bibliometrics. london: routledge web of science and scopus: a journal title overlap study bibliometric methods in management and organization changes in the intellectual structure of strategic management research: a bibliometric study of the strategic management journal bibliometrix: an r-tool for comprehensive science mapping analysis a bibliometric analysis of six economics research groups: a comparison with peer review the use of bibliometric analysis in research performance assessment and monitoring of interdisciplinary scientific developments an approach for detecting, quantifying, and visualizing the evolution of a research field: a practical application to the fuzzy sets theory field years at knowledge-based systems: a bibliometric analysis mapping the intellectual structure of mis, - : a cocitation analysis a revealed preference study of management journals' direct influences scientific collaboration networks. i. network construction and fundamental results scientific collaboration networks. ii. shortest paths, weighted networks, and centrality analysing scientific networks through coauthorship. in handbook of quantitative science and technology research scholarly network similarities: how bibliographic coupling networks, citation networks, cocitation networks, topical networks, coauthorship networks, and coword networks relate to each other canadian collaboration networks: a comparative analysis of the natural sciences, social sciences and the humanities evolutionary dynamics of scientific collaboration networks: multi-levels and cross-time analysis co-citation in the scientific literature: a new measure of the relationship between two documents bibliometrics, citation analysis and co-citation analysis: a review of literature i. libri document co-citation analysis to enhance transdisciplinary research author cocitation: a literature measure of intellectual structure the intellectual structure of the strategic management field: an author co-citation analysis co-word analysis as a tool for describing the network of interactions between basic and technological research-the case of polymer chemistry the challenge of co-production. london: new economics foundation london: the health foundation patient involvement in europe-a comparative framework health care customer value cocreation practice styles human factors of complex sociotechnical systems patient and public involvement in the coproduction of knowledge: reflection on the analysis of qualitative data in a mental health study ageing with telecare: care or coercion in austerity? sociol health illn does physicianpatient communication that aims at empowering patients improve clinical outcome?: a case study evaluating knowledge exchange in interdisciplinary and multi-stakeholder research coproduction of healthcare service beyond engagement and participation: user and community coproduction of public services consumers as coproducers of public services: some economic and institutional considerations coproduction: citizen participation in service delivery co-production, the third sector and the delivery of public services: an introduction it takes two to tango? understanding the c oproduction of public services by integrating the services management and public administration perspectives why do public-sector clients coproduce? toward a contingency theory towards developing new partnerships in public services: users as consumers, citizens and/or co-producers in health and social care in england and sweden oecd (organisation for economic cooperation and development) service-dominant logic: continuing the evolution on value and value co-creation: a service systems and service logic perspective psychological implications of customer participation in co-production evolving to a new dominant logic for marketing service-dominant logic: reactions, reflections and refinements health care: a fertile field for service research gaining compliance and losing weight: the role of the service provider in health care services a new theory for public service management? toward a (public) service-dominant approach value co-creation through patient engagement in health care: a micro-level approach and research agenda from public service-dominant logic to public service logic: are public service organizations capable of co-production and value cocreation? from engagement to co-production: the contribution of users and communities to outcomes and public value. volunt int j volunt nonprofit org integrated knowledge translation (ikt) in health care: a scoping review achieving research impact through co-creation in community-based health services: literature review and case study lost in knowledge translation: time for a map? coproduction without experts: a study of people involved in community health and well-being service delivery innovating relationships: taking a co-productive approach to the shaping of telecare services for older people the impact of personalisation on people from c hinese backgrounds: qualitative accounts of social care experience how do public health professionals view and engage with research? a qualitative interview study and stakeholder workshop engaging public health professionals and researchers embedded research: a promising way to create evidenceinformed impact in public health? well london'and the benefits of participation: results of a qualitative study nested in a cluster randomised trial development of a framework for the co-production and prototyping of public health interventions co-designing social marketing programs co-production at the strategic level: co-designing an integrated care system with lay co-production in practice: how people with assisted living needs can help design and evolve technologies and services research into practice: collaboration for leadership in applied health research and care (clahrc) for lincolnshire (ndl) collaborative and partnership research for improvement of health and social services: researcher's experiences from projects tco-production in chronic care: exploitation and empowerment the interdependent roles of patients, families and professionals in cystic fibrosis: a system for the coproduction of healthcare and its improvement health care user perspectives on constructing, contextualizing, and co-producing "quality of care to be treated as a human': using co-production to explore experts by experience involvement in mental health nursing education-the commune project supporting shared decision-making for older people with multiple health and social care needs: a protocol for a realist synthesis to inform integrated care models the day-to-day co-production of ageing in place evaluation of a co-delivered training package for community mental health professionals on service user-and carer-involved care planning understanding recovery in the context of lived experience of personality disorders: a collaborative, qualitative research study the recovery college: a unique service approach and qualitative evaluation the development of a prototype measure of the co-production of health in routine consultations for people with long-term conditions empowering people to help speak up about safety in primary care: using codesign to involve patients and professionals in developing new interventions for patients with multimorbidity an evaluation of knowledge and understanding framework personality disorder awareness training: can a co-production model be effective in a local nhs mental health trust? reframing healthcare services through the lens of co-production'(rhelaunch): a study protocol for a mixed methods evaluation of mechanisms by which healthcare and social services impact the health and well-being of patients with copd and chf in the usa and the netherlands building a patientcentered and interprofessional training program with patients, students and care professionals: study protocol of a participatory design and evaluation study when the customer is the patient: lessons from healthcare research on patient satisfaction and service quality ratings clinical efficacy and cost-effectiveness of outpatient parenteral antibiotic therapy (opat): a uk perspective antibiotic management and early discharge from hospital: an economic analysis clinical efficacy, cost analysis and patient acceptability of outpatient parenteral antibiotic therapy (opat): a decade of sheffield (uk) opat service publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we would thank the developers of the software "bibliometrix" for their support and the reviewers for their valuable suggestions. supplementary information accompanies this paper at https://doi.org/ . /s - - - . authors' contributions all the authors have made substantial contribution to the manuscript. in particular, mm and cg conceived the study; ff performed the statistical and data analysis and wrote the first draft of the paper; mm and cg critically reviewed the manuscript to reach the current version. all authors read and approved the final manuscript. no funding was obtained for this study. all data generated or analysed during this study are included in this published article (and its supplementary information files).ethics approval and consent to participate not applicable. not applicable. the author declares that he has no competing interests.received: july accepted: april key: cord- -fk s v authors: babatunde, gbotemi bukola; van rensburg, andré janse; bhana, arvin; petersen, inge title: stakeholders' perceptions of child and adolescent mental health services in a south african district: a qualitative study date: - - journal: int j ment health syst doi: . /s - - - sha: doc_id: cord_uid: fk s v background: in order to develop a district child and adolescent mental health (camh) plan, it is vital to engage with a range of stakeholders involved in providing camh services, given the complexities associated with delivering such services. hence this study sought to explore multisectoral dynamics in providing camh care in one resource-constrained south african district as a case study, towards informing the development of a model for district mental health plan and generating lessons for mental health systems strengthening to support camh services using the health systems dynamics (hsd) framework. hsd provides a suitable structure for analysing interactions between different elements within the health system and other sectors. methods: purposive sampling of key informants was conducted to obtain an in-depth understanding of various stakeholders' experiences and perceptions of the available camh services in the district. the participants include stakeholders from the departments of health (doh), basic education (dbe), community-based/non-governmental organizations and caregivers of children receiving camh care. the data was categorized according to the elements of the hsd framework. results: the hsd framework helped in identifying the components of the health systems that are necessary for camh service delivery. at a district level, the shortage of human resources, un-coordinated camh management system, lack of intersectoral collaboration and the low priority given to the camh system negatively impacts on the service providers' experiences of providing camh services. services users' experiences of access to available camh services was negatively impacted by financial restrictions, low mental health literacy and stigmatization. nevertheless, the study participants perceived the available camh specialists to be competent and dedicated to delivering quality services but will benefit from systems strengthening initiatives that can expand the workforce and equip non-specialists with the required skills, resources and adequate coordination. conclusions: the need to develop the capacity of all the involved stakeholders in relation to camh services was imperative in the district. the need to create a mental health outreach team and equip teachers and caregivers with skills required to promote mental wellbeing, promptly identify camh conditions, refer appropriately and adhere to a management regimen was emphasized. page of babatunde et al. int j ment health syst ( ) : policy documents have helped to spur this [ ] [ ] [ ] , notably the world health organization's (who) policy framework for child and adolescent mental health policies and plans [ ] . however, the paucity of specific national camh policies and national implementation guidelines, poor intersectoral collaboration and the shortage of camh resources still hinder the provision of optimal child and adolescent mental health services in many countries [ ] . the burden of camh has been well-described, especially in lmics [ , ] . barriers to camh service provision in lmics will undoubtedly be aggravated by the covid- pandemic, an event that will substantially test the resilience and responsiveness of district health systems. it has already been noted that the pandemic will add to the current camh burden, and a strong system of governance, service provision and financing will be vital to ensure the well-being of children and adolescents [ ] . two considerations have especially been part of strategies to reform camh services, namely task-sharing and intersectoral working. while camh services have historically been framed to be the sole responsibility of specialists, some recent studies have revealed the possibility and significance of integrating camh services into primary health care (phc) through the tasksharing approach [ , , , ] . notably, the mental health gap project (mhgap) [ ] includes guidelines for the management of several camh conditions at phc level within a task-sharing approach. in terms of intersectoral working, camh has historically been under the stewardship of the health sector. an intersectoral approach that involves the collaboration of other sectors such as education, social development and juvenile justice is required to achieve an effective camh system of care [ , ] . while these considerations have been central to south africa's health policy landscape, the country lacks a wellarticulated camh strategy which is required to achieve a functional camh collaborative system at a district level [ , ] . in the development of such a strategy, there is a need to involve a wide variety of stakeholders across multiple sectors, including caregivers, teachers, community and spiritual leaders [ ] . haine-schlagel et al. [ ] , emphasized that engaging various stakeholders was critical to achieving an effective camh service delivery. these multiple stakeholders, particularly teachers and caregivers (parents, grandparents, foster parents and other family members), are perceived to be active gatekeepers to camh care, given their vital role in identifying and seeking help for children and adolescents with mental (behavioural, emotional, social and developmental) disorders. despite the inclusion of camh in core national documents like the policy guidelines on child and adolescent mental health [ ] and the national mental health policy framework and strategic plan - [ ] , within the ideals of integrated, collaborative care (including task-sharing and intersectoral working, little to no guidance exists for provincial and district governments to translate national guidelines into operational tools for district governance of camh services. considering this, the study aimed to explore multisectoral dynamics in providing camh care in one resource-constrained south african district as a case study, towards informing the development of a model for district mental health plan and generating lessons for mental health systems strengthening to support camh services. the study was guided by the health service delivery (hsd) framework which describes health service delivery as a process by which policies, services providers and infrastructures are organized to achieve the goal of the health system which is to provide easily accessible and quality healthcare services [ ] . the framework consists of ten elements, they include, ( ) goals and outcomes, ( ) values and principles, ( ) service delivery, ( ) the population, ( ) the context, ( ) leadership and governance, ( ) finances, ( ) human resources, ( ) infrastructure and supplies, ( ) knowledge and information. the premise of the hsd framework is that the health system is an open system which is often shaped and influenced by different societal factors. it describes health service delivery as a process by which policies, services providers and infrastructures are organized to achieve the goal of the health system which is to provide easily accessible and quality healthcare services. moreover, resources such as budget allocation, human resources, infrastructure and supplies, knowledge and information are fundamental to achieving a viable healthcare system for the populace. the population (service users) are described as major players within the health system. the authors emphasized that they are not mere patients but also citizens having rights to access quality healthcare. governance, as described by the hsd framework, entails policy guidance, coordination of the different stakeholders and activities at different levels of care and effective distribution of resources to ensure equity and accountability [ ] . an instrumental case study which is used to obtain an in-depth understanding of specific issues was conducted with the amajuba district municipality as the unit of analysis [ ] to explore the experiences of providing and accessing camh services in the district. employing a phenomenological qualitative approach using semi-structured interviews, the design allowed for the generation of in-depth information about lived experiences from multiple stakeholder perspectives [ ] . the study was conducted in the amajuba district municipality, in the north-west region of the kwazulu-natal province of south africa. the district which covers km with a population estimate of about , , is made up of sub-districts and comprises rural and periurban communities [ , ] . amajuba has been identified as a resource-constrained district as it has limited numbers of health professionals, including mental health specialists to provide adequate health care services for the populace [ ] . the bulk of the district's camh service capacity is situated in its three provincial hospitals. the district was a site for government piloting of the national health insurance programme-a government-driven initiative aimed to unify south africa's two-tiered health system by establishing a centralised funding mechanism in order to achieve universal health coverage [ ] . as part of its pilot site status, the district had limited school mental health services as part of the integrated school health programme, an extension of the revitalisation of phc, that includes teams of health care workers (hcws) visiting schools to conduct basic screening and referral services [ , ] . research participants were purposively identified according to their positions in the departments of health, social development and education. snowball selection was applied, leading to the identification and participation of key role players involved in providing mental health care to children and adolescents in the district. participants included managers and mental health professionals from the department of health, managers, educators and mental health support workers from the department of basic education, non-governmental service representatives, as well as caregivers of children and adolescents living with mental health challenges. a list of camh cases and conditions identified in the district over months have been published elsewhere [ ] . these conditions included autism spectrum disorder, attention-deficit/ hyperactivity disorder (adhd), different forms of intellectual disability, depression, schizophrenia, bipolar affective disorders, mood disorder, anxiety, conduct disorder, mental and behavioral disorders tied to substance abuse. a full list of participants and the characteristics of children whose caregivers were included in this study are presented in tables and . data gathering for this study took place from february to march . semi-structured interviews were used, allowing for the use of probes and follow-up questions to steer the discussion while allowing for the generation of in-depth subjective information [ , ] . the interview guide was informed by the findings of an initial review of literature on the barrier and facilitators of camh services in low-and -middle-income countries [ ] and the hsd framework. the interview guide covered a range of questions that explored the roles played by each stakeholder in relation to camh services, their perceptions, and experiences of child and adolescent mental health; experiences of accessing and providing camh services, and suggested pathways for systems improvement. all the stakeholders included in this study were either physically visited in their offices or contacted via e-mail, text messages, and telephonically to inform them and solicit their participation in the study. the majority of the stakeholders responded positively, and interview dates and time were secured. the operational manager at the madadeni hospital psychiatric out-patient department and the clinical psychologist at the newcastle hospital assisted with identifying caregivers and introduced them to the researchers. the caregivers were then informed about the study during clinic days and twenty caregivers consented to participate in the study. interviews were conducted in english and isizulu, depending on interviewee preference. the primary researcher (gbb), a doctoral student, conducted the english interviews while the isizulu interviewers were conducted by a trained research assistant with a bachelor's degree, who is proficient with the use of both isizulu and english language. the research assistant is also a resident of the community, and this facilitated easy rapport with the stakeholders. the interviews were audio-recorded, transcribed verbatim, translated, and back-translated where required. transcribed data were analysed using gale et al. 's [ ] framework method, a summary process for managing and analysing qualitative data, which produces a series of themed matrices [ ] . accordingly, six steps were followed: ( ) transcription, ( ) familiarisation, ( ) deductive organisation of codes based on the elements of the hsd framework, ( ) inductive coding of sub-themes under the hsd coding framework, ( ) reviewing data extract and charting ( ) mapping and interpretation of data [ , ] . using these interconnected steps enabled the researchers to sort, scrutinise, categorise and chart the themes and associated sub-themes that emerged from the data set [ , ] . the categories were reviewed to identify existing connections and differences between the themes from the different groups of stakeholders [ ] . the excel software package ( ) was used in creating framework matrices and coding the entire data set. the accuracy of transcripts was checked against original recordings, and the two researchers (gbb and av) who conducted the analysis compared results at regular time points to harmonise the content of themes derived from raw data. also, the classification was discussed iteratively between the researchers, with input from study supervisors (ab and ip). to further ensure trustworthiness, the data set was thoroughly read through to confirm that the data was meaningfully clustered under the the themes and subthemes of the findings are presented here in narrative form, according to the constructs of the health system dynamics framework, starting with service delivery. direct quotations are added to illustrate key points. themes under this component will describe the structure of the camh system in the amajuba district. this includes a general "overview of camh services", and "identification and referral". camh services in amajuba district municipality were diverse. public sector professional mental health services were provided in a largely centralised fashion by psychologists based at the district regional hospital. this hospital served as a referral point for at-risk learners identified within the school system. service providers who helped to identify and refer children and adolescents potentially requiring mental health care were situated at different levels of the community, health and education systems, and included nurses in clinics, social workers in the communities, educators, learner support agents and school health nurses in schools. beyond the public health system, there were also a variety of non-government service providers who provided mental health services such as awareness campaigns, assessment and referrals to a limited degree. this included general practitioners, religious counsellors, non-governmental/non-profit organizations (ngos/npos) and traditional healers. in terms of the content of camh services, health care involved psychotherapy and psychopharmacological support, largely provided in the hospitals. educators and caregivers mentioned additional interventions to assist children in the school environment and at home. extra classes were organized for learners identified to be dealing with psychological challenges and struggling academically. they expressed that these interventions were insufficient and were negotiating for professional psychological assistance for the learners from the department of education. further, the department of social development provided disability grants to children with intellectual disabilities and autism, illustrated by the following: "i was advised to register her for the disability grant from the government, so that helps cater for her needs. we are fine financially because she receives the grant." (caregiver ). a service that was described as especially problematic was early identification of camh problems and appropriate referral; with most camh conditions identified and referred by the school system-but were generally quite late in the illness progression, when they were affecting children's academic performances. very few cases were identified by health workers in hospitals, phc clinics, ward-based primary health care outreach teams (wbphcots), or by the caregivers. this finding was illustrated by the following: "in most cases what i found is that children are identified by their educators. they are identified there in school and then referred to the clinic and then from the clinics to us here. and, there are few cases where children are brought to the hospital for other things and mental health issues are picked up as a secondary problem that is seen, but otherwise in most cases it's the educators unless a child has a clear mental health issue that is visible then the child is brought into the health system by the caregiver." (clinical psychologist ). once a child has been identified as needing mental health care, further steps depend on the specific space where identification occurred, and the nature of the perceived need. the educators and learning support agents (lsa) in schools mentioned that they provided some initial assessment and interventions before referring the children for further care. however, four of the twelve schools visited within the district still did not have any skilled staff or resources to provide initial camh assessment or interventions to assist their learners, they also did not have any information on the referral pathways. integrated school health programme (ishp) teams were yet to adopt mental healthcare into their activity portfolio. "we identify learners who have special needs, behavioral problems or learners who are abused physically, emotionally and socially. firstly, we screen those learners, fill the necessary forms and then we sit down with the learners to find out what the problem is, identify how we can help and if we cannot help, we call in supervisors from the dbe district office, then they will come and assist. they either do one-on-one sessions or sometimes they will take a group for assessment. after assessing them, if they see that the learners do have problems, they refer those learners to special schools. if it's a behavioral problem, they make sure that they do follow-up interventions like counselling or social work consultation and they refer some of the learners to the psychologists." (lsa, school c). a principal mentioned the need to train educators to prevent inappropriate referral and labelling. "….to take this matter seriously we need some resources to assist the schools, then the training of teachers also is important. i don't want teachers to wrongly identify and say it behaviour problem when the learner does not want to write due the relationships you have with that learner-so training of teachers is very important-so that they can be able to identify the learner." (principal ). a senior mental health professional highlighted that the psychologists are mostly the first point of contact for children and adolescents with camh conditions within the hospital (most of the referrals from the schools are addressed to them) and they refer them to the appropriate specialists for cases in need of more specialized interventions. according to one of the psychologists: "when they come to us, they are mostly accompanied by their caregivers, if maybe they come from school they come with their educators. so, we do the debriefing to sort of understand the child's condition and give us a picture of what is going on so that we can determine which services they need, and then if they need to be referred to other specialists, we do that. (clinical psychologist ) . the psychologist also mentioned inappropriate referral from schools, children with learning disabilities that should be referred to educational psychologists are referred to the clinical psychologists. this is due to the shortage of educational psychologists in the district, thereby resulting in back referral. "children with learning difficulties are often referred to us but we always refer them back to the department of education because they have an educational psychologist. we understand that she is the only one for the district, and she's not coping. because of this, schools tend to push them towards the department of health, but we don't do those assessments". (clinical psychologist ). the availability and organization of camh resources in the district are presented below, according to human resources, infrastructure, and supplies, knowledge, and information. participants described a severe shortage of human resources to deal with camh problems within the departments of health and basic education. the service providers within doh mentioned that they are overwhelmed due to limited camh human resources, increasing camh workload and inadequate camh training for non-specialists. there was a widely-held view that camh services are limited in the district, but there was also sympathy from several participants that the few service providers were doing their best, and-under the circumstancespurportedly provided highly responsive care. caregivers were appreciative of the good communication and friendly engagement of key mental health professionals. this was illustrated by the quotation below: "we got a very great help, they really helped us, especially the provincial hospital… the services were very good, and they were very helpful. the medication he receives here is helping a lot. they communicate with me properly, i was even able to ask questions and they could answer, they have been very caring towards me and the child, so i can say it was very good. " (caregiver ). the lack of mental health human resources, and the resulting limitations in providing care, was bemoaned by one mental health participant as follows: unfortunately, we can't see them more than once a month like everyone else because of staff shortage. however, if there is an urgent need for treatment, like sometimes we do fear that these persons might do something to harm themselves then we try to squeeze them in, but we just see them once a month. we usually make appointments in the mornings for people to come and see us… however, for school going-children we do make provisions for them, we see them in the afternoons, we schedule their appointments for pm, so that at least they will be able to go to school in the morning. " (psychologist ). some medical professionals noted that camh services provided opportunities for self-development, as most of them are medically qualified professionals without formal qualifications in psychiatry or child and adolescent psychology. "i enjoy providing camh services …it's very interesting and challenging but i learn from the experience and it motivates me to develop my skills…i was working with a doctor who was about to retire so i joined her and she exposed me to one or two things before she left. i have some years of experience in it now, but i'm not a child and adolescent specialist, we don't have any in the district as well. " (medical officer ). the psychiatrist suggested that the camh system could be strengthened through the development of outreach teams to expand the camh workforce, ensure consistent in-service training across all the departments involved in delivering camh services, particularly for phc nurses to facilitate the integration of camh services into primary health care, conduct awareness campaigns and provide psychosocial support to families to strengthen the existing camh system. schools so that they can do in-service training and awareness campaigns… visit families because they need to capacitate them and support them. also, training, i have been yearning for this, the phc staff members should undergo camh training. " (psychiatrist). findings revealed that there were very few special schools catering for children with special needs in the district, and only two of them were equipped to admit children with camh conditions. an educator from one of the two schools stated that the school was overpopulated due to the increasing prevalence of camh in the district: "at first, we had the capacity of , but due to the increasing number of children with mental disabilities we have about leaners, our school is full. " (educator , special school ). there was widespread concern about the challenge of finding suitable schools for children whose mental health needs could not be met by their current schools. some children were not enrolled into school at all, because they were rejected by the mainstream schools, with the limited special schools available in the district being overwhelmed due to the lack of space and shortage of resources. a caregiver relates this as follows: "i once struggled to find a school for him and i am still having that challenge because i am yet to find one that can accept him. " (caregiver ). in cases where caregivers were successful in placing their children in special schools, they received additional support in the form of transport services, as described below: "he is now studying in a special school, where they have trained teachers who are knowledgeable about his condition, so i am happy he is in the right place. they taught him how to write when he got there…he's now trying to write his name. it is just okay because they also provide him with transport. " (caregiver ). the chief director of special schools from the district department of education explained the school placement procedure. "first, we do the placement assessment, when a leaner is referred for special school placement. a committee which consist of an occupational therapist, physiotherapist, the hod and the class teacher will sit to decide. we assess the physical ability of the child and then cognitive assessment all these assessments will assist us with class placement. you know, sometimes the learner comes to us at the age of and never accessed any form of education, but we can't place them in the first year of school. after series of assessments, once we realize the level of assistance needed by the learner, we then recommend placement, we will then ask the parents to sign a consent form where they would agree that the learner should be enrolled into a special school. " (chief director, special schools). a caregiver also voiced her concern about the lack of higher education or opportunities for career development for adolescents with mental disabilities. "my worry is that when they reach the age of they should not just stay home, there must be something for them to do because people take advantage of children in these kinds of conditions because a lot of them tend to wonder in the street after they leave school. maybe the government could help build a school that can take those that are over the age of . " (caregiver ). there seemed to be a lack of knowledge in communities on identifying mental health symptoms at an early stage. in some cases, caregivers noticed some symptoms at an earlier stage, but they couldn't specify the nature of condition and did not access care for the child until they were identified and referred from school. these caregivers also mentioned that they could not seek help for the children because they didn't have a clear understanding of the conditions, where and how to seek medical care. this is illustrated below: "i noticed before the school called me, but i couldn't take any step because i didn't know what the problem was and where to take him for treatment until he was referred by the school, they gave me a letter and i took her to the hospital. " (caregiver ) . some caregivers reported that they noticed certain symptoms of abnormality. although they couldn't ascertain the nature of the problem, they immediately sought help for the child. two of the caregivers took their children to the clinics close to them and were referred to the hospital while others took their children directly to the hospital. however, the caregivers who took their children directly to the hospital mentioned that they were requested to obtain referral letters from the school or a clinic. the following excerpt refers: "we noticed the problem at home, but we couldn't identify it as autism, so i brought him here to the hospital but then they said i should get a letter from his school about his condition. " (caregiver ). the results under this component reveal the characteristics of the camh service users mainly caregivers of children with camh challenges in the district. government stakeholders described particular challenges in engaging with caregivers of children and adolescents with mental health needs. many caregivers were yet to accept their children's conditions and struggled to comply with the prescribed treatment regimen, and highlighted below: "i love working with the children but some of the caregiver are in denial they don't adhere to what you tell them whether its homework, time keeping, bookkeeping. it's kind of frustrating because you know the child should be improving, but the child is not because the parent or caregivers are not adhering. " (psychologist ). the challenging nature of child and adolescent mental health conditions led to many of the caregivers describing feelings of concern, helplessness and exhaustion, as expressed below: "i cried a lot and even now i haven't accepted it because i have two children, both have same condition. i accepted with the first one, but i couldn't accept with the second one. it was really hard, and people were talking all they want about me and making fun of me that they rejected my children from school. " (caregiver ). the complicated nature and under-resourcing of camh conditions further have a substantially negative effect on educators, not to mention the critical weight such conditions have on children's functioning, daily interactions with their environment, emotions, behaviors and academic performance, resulting in, among others, poor academic performance, school truancy and dropout. the below quotation refers: "their conditions affect us a lot; particularly it makes me sad. it affects us to such an extent that we end up not knowing what to do because we encounter such problems each and every day and there is no way we can help the children. it also affects their academic performance many of them are not doing very well academically, and some of them exhibit some behavioral problems. sometimes we spend extra time to assist some of them, we visit their homes and even give some learners money to buy grocery. " (educator ). participants pointed to the lack of a coordinated system of camh care as a major barrier to providing and accessing camh services in the district. this was exemplified by, particularly, poor intersectoral collaboration, and the lack of a standardised procedure and coordination for delivering camh services across the various departments in the district. there were no adequately integrated procedures for managing and reporting camh cases. one participant referred to the overall system of care for children living with camh conditions in the district as "disjointed". an example of this disjointedness was that certain services were packaged for children in different age groups across the two hospitals, which often required caretakers to find means of transporting the children between the hospitals to access different specialist services. this is illustrated in the quotation below: factors that were perceived to impede camh service provisioning from the wider contexts of the district emerged. the coalescence of the district disease burden and resource shortages resulted in very limited health awareness being conducted, which in turn resulted in poor mental health literacy. tied to this barrier, it was often mentioned that there are high levels of stigma towards mental illness among children and adolescents, illustrated by the following: "she does get discriminated which is something that pains me a lot. we are even afraid to send her to the shops and they even discriminate her because of the school she is going to. " (caregiver ). dysfunctional family systems were raised as a major risk factor and barrier to accessing camh services for children. the participants particularly emphasized the absence of parents-leaving children to the care of grandparents and other family members or leaving adolescents to care for themselves as a major problem in the community. the following quotation illustrates this point: "…most are from broken families; they stay with elderly people and we've got children heading the family. " (principal). "some of the parents are not staying with their children, they work and stay out of town… they come on month ends-just providing money-and leave the children to guide themselves. some children are in distressful situations because they were in a way abandoned by their parents. " (sanca coordinator). the study sought to explore service providers and service users' experiences of providing and accessing camh services and their perceptions of the available camh services in the district using the health system dynamics framework. key barriers and facilitators emerged for camh in the amajuba district municipality. certain community factors such as low mental health literacy resulting in misconceptions and stigmatization, and the dysfunctional nature of the family system within the communities were highlighted as major camh risk factors within the district that impedes access to camh services. community-based stigma can prevent caregivers from seeking help for their children, heflinger and hinshaw [ ] stated that stigmatization increases the burden caused by mental illness and is a major barrier to accessing and utilizing mental health services. according to brannan and heflinger [ ] , caregivers of children with mental disorders often experience the pernicious impacts of stigma and therefore delay accessing mental health services for their children. the study further revealed that the shortage of resources particularly camh specialists, lack of intersectoral collaboration and poor coordination, financial restrictions, and the low priority given to camh services in the district negatively impacts on the state of camh and serves as barriers to accessing camh services in the district. nevertheless, the few available camh specialists were perceived to be competent and dedicated to delivering quality services but could benefit from systems strengthening initiatives that could expand the workforce and equip them with the required skills, resources and adequate coordination. these findings corroborate the findings of a recent study conducted in the western cape province of south africa by mokitimi et al. [ ] which highlighted inadequate camh resources, lack of priority for camh services and low levels of advocacy for camh services as major weaknesses of camh services in the province. the shortage of educational psychologists which resulted in inappropriate referrals, disruption of assessment procedures for children with intellectual disabilities and increased workload for the limited available clinical psychologists was reported as a major barrier to camh services by the doh stakeholders. hence, the need to employ more educational psychologists by the department of education to address the needs of children with learning challenges was suggested. stakeholders also suggested the provision of in-service camh training for psychiatric nurses, school health nurses, social workers and phc workers which could facilitate the adoption of a task-sharing approach considering the shortage of camh specialists in the district. while schools play a vital role in the identification and referral of camh challenges [ ] , the dbe stakeholders reported that they lack the required skills, time and tools to adequately screen and refer children thereby hindering many children and adolescents living with camh conditions from accessing the required camh services. the lack of appropriately defined referral pathways for children and adolescents identified as having mental health problems also emerged as a major barrier to providing adequate camh services within the school environment. as mentioned earlier, the majority of children within the school environment identified as in need of mental health services were referred directly to the hospitals which resulted in bottlenecks, with long waiting lists. therefore, the dbe stakeholders suggested that efforts to build teachers' capacity to facilitate early identification, screening and referral for children and adolescents at risk to optimize their health and development, as well as their academic potential, should be explored. this would assist the teachers to distinguish between learning problems that should be referred to educational psychologists, social problems that require social work interventions and mental health conditions that require the services of clinical/counselling psychologists. a study conducted by cappella et al. [ ] , emphasized the significant roles of teachers in delivering camh services. they proposed the use of an ecological model to strengthen teachers' capacity and facilitate active collaboration with mental health specialist for the reformation of schoolbased mental health services in low resource settings. the study underlined the lack of a coordinated and integrated system of camh services particularly the lack of collaboration between the different sectors providing camh services in the district. this lack of adequate coordination and collaboration accounts for the inadequate communication between the different sectors, undefined screening/assessment procedure and referral pathways which results in delayed access to mental health care and the development of required interventions to address the various conditions affecting children. this finding is similar to the findings of previous studies conducted in ghana, uganda, zambia and south africa [ , , ] which identified the consequences of a weak intersectoral collaboration for the delivery of mental health services particularly camh services in low resource settings. the study participants emphasized the impact of camh conditions on the academic performance of children and adolescents which is further compounded by the shortage of special schools, the difficulties associated with securing school placements, the inadequate attention paid to the quality of education obtained and the lack of opportunities to pursue higher or vocational education after completing basic education for children and adolescents with camh challenges. many children and adolescents living with learning disabilities are not receiving the required educational help for their special needs leaving them to helpless. this finding corroborates the findings of a study conducted in a south african peri-urban township by saloojee et al. [ ] who found that many children with intellectual disabilities are not enrolled in schools. the caregivers mentioned financial constraints, lack of knowledge on how to access the available services and lack of psychosocial support which they encountered daily in their pursuit to alleviate the conditions of their children. previous studies [ , , , , , ] have also highlighted the psychological, physical and financial burden associated with caring for people with mental health challenges and the need to develop interventions that would equip caregivers with skills to alleviate these burdens. caregivers are central to camh prevention and effective management but require consistent support to acquire the necessary coping, communication, resilience, problem-solving and stress management skills. moreover, the need for intensive camh awareness programs was suggested by the participants as well as the need to organize camh outreach teams to disseminate camh information and implement community based camh services in the district. according to the participants, these strategies will increase the knowledge of camh within the communities and could eliminate stigma and misconceptions around camh conditions. however, hinshaw [ ] proposed that stigma operates on multiple levels and mere public education programs might not resolve the problem of stigmatization. therefore, the need to incorporates different change strategies targeted at the different interacting levels within the communities is required. while a purposive sampling technique was used in selecting the study participants to obtain in-depth information on the current state of camh in the district, we acknowledge the various categories of stakeholders were a product of the differential availability of the stakeholders. it is possible that we might not have adequately captured the perspective of other key informants, particularly those within other sectors outside the dbe, doh and ngos/ cbos partnering with doh and dsd. however, the study included different categories of stakeholders to obtain rich data about the experiences and perceptions of camh service delivery in the district. the findings of this study suggest the need to create a district camh intersectoral coordinating or liaison forum to facilitate joint camh service planning and implementation to develop intersectoral agreements, developing defined referral pathways between relevant sectors, mobilizing resources, optimizing available resources within each sector, clarifying roles and responsibilities of the different sectors, promoting awareness and staff training on camh. moreover, the need for continuous in-service training and capacity building through supervision and mentorship for stakeholders in each of the sectors cannot be overemphasized as in-service training, mentorship and specialists support can facilitate the acquisition and the willingness to implement new skills. additionally, the development of management guidelines specifying the management procedures (identification, assessment, referral, treatment/interventions) for each sector and at the different levels of care should be prioritized. it is important to address the educational needs of children and adolescents living with camh challenges by mobilizing resources such as providing learning equipment, building more classrooms and creating professional support teams to expand the capacity of the available special schools to accommodate children and adolescents living with severe camh conditions specifically learning difficulties in the district. increased attention should also be paid to educating and providing the necessary socioeconomic support for caregivers of children and adolescent with camh conditions. caregivers should be sensitized about the importance of actively participating and complying with the management regimen recommended for their children's conditions within the health care system and school. it is also important to invest in a rigorous approach to disseminating mental health education especially camh information within the district to eliminate discrimination and stigma. these information dissemination strategies should include the transmission of camh messages using public-social media platforms, ensure regular camh information contacts at the community levels and provide adequate support and education at the family level. in conclusion, the need to build the capacity of all the involved stakeholders in relation to camh services is imperative in the district. although teachers and caregivers are not in a position to treat camh conditions, they can be equipped to identify children and adolescents with incipient mental health problems so that they access care early on in the illness progressions. they can also be equipped with knowledge and skills to support children and adolescents with mental health problems and adhere to management regimens. teachers could be assisted to promote mental health and resilience, identify and refer camh conditions through enhancing their mental health literacy and providing them with validated and appropriate screening tools. creating mental health outreach teams could further facilitate camh awareness within the communities thereby enhancing camh literacy and access to quality camh services. this could also potentially relieve the burden of care placed on the limited specialists and ensure a functional and sustainable collaborative system of camh care in the district. amajuba district municipality spatial development framework. (sdf) challenges of caring for children with mental disorders: experiences and views of caregivers attending the out-patient clinic at muhimbili national hospital evaluation of phase implementation of interventions in the national health insurance (nhi) pilot districts in south africa the practices of social research (south africa edition). cape town: oxford up barriers and facilitators to child and adolescent mental health services in low-and-middle-income countries: a scoping review planning for child and adolescent mental health interventions in a rural district of south africa: a situational analysis caregiver, child, family, and service system contributors to caregiver strain in two child mental health service systems using thematic analysis in psychology enhancing schools' capacity to support children in poverty: an ecological model of school-based mental health services grand challenges in global mental health: integration in research, policy, and practice collaboration between mental health and child protection services: professionals' perceptions of best practice burden among the caregivers of children with intellectual disability: associations and risk factors research at grass roots. pretoria: van schaik national policy guidelines for child and adolescent mental health department of health. national health insurance in south africa: policy paper department of health. national mental health policy framework and strategic plan - . pretoria: department of health the global coverage of prevalence data for mental disorders in children and adolescents using the framework method for the analysis of qualitative data in multi-disciplinary health research coronavirus disease (covid- ) and mental health for children and adolescents weighing up the burden of care on caregivers of orphan children: the amajuba district child health and wellbeing project we're tired, not sad": benefits and burdens of mothering a child with a disability stakeholder perspectives on a toolkit to enhance caregiver participation in communitybased child mental health services stigma in child and adolescent mental health services research: understanding professional and institutional stigmatization of youth with mental health problems and their families the stigmatization of mental illness in children and parents: developmental issues, family concerns, and research needs opportunities and obstacles in child and adolescent mental health services ifn low-and middle-income countries: a review of the literature what works where? a systematic review of child and adolescent mental health interventions for low-and middle-income countries a situational analysis of child and adolescent mental health services in ghana, uganda, south africa and zambia a national profile of caregiver challenges among more medically complex children with special health care needs evergreen: towards a child and youth mental health framework for canada. j can acad child adolesc psychiatry harrington r. primary mental health workers in child and adolescent mental health services national health insurance: the first months child and adolescent mental health services in south africa-senior stakeholder perceptions of strengths, weaknesses, opportunities and threats in the western cape province child and adolescent mental health policy in south africa: history, current policy development and implementation, and policy analysis the health of caregivers for children with disabilities: caregiver perspectives. child care health dev barriers to managing child and adolescent mental health problems: a systematic review of primary care practitioners' perceptions whose responsibility is adolescent's mental health in the uk? perspectives of key stakeholders update on adolescent mental health language and meaning: data collection in qualitative research burden and coping in caregivers of persons with schizophrenia qualitative research practice: a guide for social science students and researchers unmet health, welfare and educational needs of disabled children in an impoverished south african peri-urban township. child care health dev case study research in practice mental health is everybody's business': roles for an intersectoral approach in south africa qualitative data analysis: the framework approach key stakeholders' perspectives towards childhood obesity treatment: a qualitative study the health system dynamics framework: the introduction of an analytical model for health system analysis and its application to two case-studies soliciting stakeholders' views on the organization of child and adolescent mental health services: a system in trouble nursing research: designs and methods e-book world health organization. child and adolescent mental health policies and plans. new york: world health organization world health organization. integrating mental health into primary care: a global perspective world health organization. mhgap: mental health gap action programme: scaling up care for mental, neurological and substance use disorders publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we would like to thank all the study participants who devoted their time and insight, mr. mercury nzuza, miss. patricia ndlovu, mr. fortune ngubeni and miss. kgothalang rethabile khadikane for the support provided during the data collection phase. the views expressed do not necessarily reflect the uk government's official policies. the funder did not have any involvement in the study design, collection, analysis or interpretation of data or writing of the manuscript. gbb and ip conceptualised the study, gbb collected data, gbb and av analysed data and gbb drafted the manuscript. av, ab and ip reviewed the manuscript, provided substantive revision. all authors read and approved the final manuscript. this study is an output of the programme for improving mental health care (prime). this work was financially supported by the uk department for international development ( ). g. b. b receives the university of kwazulu-natal scholarship. the datasets used and analysed during the current study are available from the corresponding author on reasonable request. gatekeeper permission was obtained from the relevant government departments, and ethics approval was provided by the biomedical research ethics committee, faculty of health sciences, university of kwazulu-natal (reference number be / ). following an informed consent procedure, permission to participate and audiotape the qualitative interviews was obtained from each respondent. not applicable. the authors declare that they have no competing interests. key: cord- -my wj uu authors: sheridan rains, luke; johnson, sonia; barnett, phoebe; steare, thomas; needle, justin j.; carr, sarah; lever taylor, billie; bentivegna, francesca; edbrooke-childs, julian; scott, hannah rachel; rees, jessica; shah, prisha; lomani, jo; chipp, beverley; barber, nick; dedat, zainab; oram, sian; morant, nicola; simpson, alan title: early impacts of the covid- pandemic on mental health care and on people with mental health conditions: framework synthesis of international experiences and responses date: - - journal: soc psychiatry psychiatr epidemiol doi: . /s - - - sha: doc_id: cord_uid: my wj uu purpose: the covid- pandemic has many potential impacts on people with mental health conditions and on mental health care, including direct consequences of infection, effects of infection control measures and subsequent societal changes. we aimed to map early impacts of the pandemic on people with pre-existing mental health conditions and services they use, and to identify individual and service-level strategies adopted to manage these. methods: we searched for relevant material in the public domain published before april , including papers in scientific and professional journals, published first person accounts, media articles, and publications by governments, charities and professional associations. search languages were english, french, german, italian, spanish, and mandarin chinese. relevant content was retrieved and summarised via a rapid qualitative framework synthesis approach. results: we found eligible sources from countries. most documented observations and experiences rather than reporting research data. we found many reports of deteriorations in symptoms, and of impacts of loneliness and social isolation and of lack of access to services and resources, but sometimes also of resilience, effective self-management and peer support. immediate service challenges related to controlling infection, especially in inpatient and residential settings, and establishing remote working, especially in the community. we summarise reports of swiftly implemented adaptations and innovations, but also of pressing ethical challenges and concerns for the future. conclusion: our analysis captures the range of stakeholder perspectives and experiences publicly reported in the early stages of the covid- pandemic in several countries. we identify potential foci for service planning and research. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. they may be disproportionately negatively affected because the area already more likely to be experiencing social isolation and exclusion, stigma, and financial, employment and housing difficulties [ , ] . potential short-term impacts on people with pre-existing mental health conditions include: • effects of being infected with covid- , including any psychiatric sequelae, potentially increased risk of being infected or of severe covid- among some groups of people with mental health conditions, and concerns regarding equitable provision of physical healthcare. • effects on people with mental health problems resulting from infection control measures, including potential impacts of social isolation, and lack of access to usual supports, activities and community resources [ ] . • challenges associated with infection control in group settings, especially in hospitals and residential settings. • the effects of reduced or re-configured mental health care delivery. various adaptations and innovations to enable mental health services to respond to new requirements have been discussed, including infection control strategies on mental health service premises, and remote working [ , ] . while a number of position papers have been published, there has been relatively little systematic documentation of the impacts of the pandemic on people already living with mental health problems and on mental health care, and of strategies to mitigate these. these have been identified as urgent priority research areas [ , ] . we aim to begin addressing this by searching for and summarising relevant material in the public domain early in the pandemic, including accounts published by people with relevant lived experience, practitioners, mental health organisations and policy makers, and also by journalists who have investigated experiences and perspectives of service users, carers and service providers. our aim was to conduct a document analysis to create an initial mapping and synthesis of reports, from a number of perspectives, on the early impacts of and responses to the covid- pandemic on mental health care and people with mental health conditions. we drew on published sources of all types and included several languages used in countries in which the impact of the pandemic has been severe. we conducted a framework synthesis to summarise themes from sources reporting narratives and experiences of the impact of the pandemic and describing responses to it at both individual and service levels. we had planned, if warranted, also to conduct a narrative synthesis of any scientific data retrieved in our search: there was little as yet (table a) : this paper, therefore, primarily reports on our analysis of a wide range of documents in the public domain through a rapid qualitative framework synthesis method. specifically, we sought to analyse reports regarding: • direct impacts of covid- , subsequent public health measures and sudden social changes on people with preexisting mental health conditions and their families; • self-help and informal help strategies utilised by service users and carers; • challenges faced by mental health services during the pandemic; • innovations and adaptations to mitigate impacts of covid- on mental health services, and reports regarding their effectiveness. rapid syntheses are recommended by the world health organization as an appropriate and timely method in rapidly developing situations [ ] , quickly providing actionable evidence that can help inform health system responses. our protocol was prospectively registered on prospero (crd ). we took a multi-faceted approach to scope a broad, rapidly updating literature base and identify reports, articles and media from a wide range of perspectives and countries. the following database and 'grey' literature searches were conducted: the detailed terms used for database and web searches appear at the end of the supplementary report (supplementary report, section ). we included items meeting the following criteria: • population mental health services, people using any mental health services or who have mental health difficulties that appear to pre-date the pandemic, or mental health service staff. • phenomenon covid- . • focus relevant to at least one of the topics above, focusing on people already living with mental health conditions at the onset of the pandemic, or on mental health care. • source type published paper, article, blog post commentary, online media (including videos and podcasts), relevant to the research questions. social media were excluded, as were blogs and articles not published via a public media channel or on the website of a public body or charity. • date january -april . • language publications in english, french, spanish, german, italian or mandarin chinese. we selected these languages as we were able to involve native speakers and anticipated a substantial relevant literature. we excluded items focusing mainly on learning disability, autism or dementia, unless combined with comorbid mental health problems, and those mainly discussing staff wellbeing. queries were raised with the wider research team and discussed until consensus was reached. a senior reviewer (sj) checked a subset of articles to validate inclusion decisions. for each included item, title, author, website address, access date, source type (e.g. journal article, news report, video, guidance, etc.), country, setting, service user group, and author background(s) were extracted. framework-based synthesis was used to enable a systematic and structured approach to rapidly summarising and analysing a large dataset [ , ] . analysis comprised the following steps: three researchers (sj, lsr and ts) familiarised themselves with relevant materials of various types, and then developed an initial analytic framework, comprising questions related to our study topics. we developed a semi-structured data collection form using qualtrics software (qualtrics, provo, ut) to capture data from each article (supplementary report, section ). eight researchers piloted the form with five articles, and the framework was adjusted and finalised based on their coding and feedback. "other" and "research reflections" categories were included to allow capture of material not covered by the initial framework. included materials from the search were indexed and charted using the online form. to conduct this work rapidly in all included languages, a large number of researchers (n = ) were involved, most postgraduates, research staff or lived experience researchers linked to university college london or king's college london. examples of well-coded articles were provided, and the first articles coded were checked (by lsr, blt, and ts) to ensure consistency, with further training for individual researchers provided as necessary. these data were then imported into microsoft excel to create the framework matrix for mapping and interpretation. twelve researchers experienced in qualitative analysis (sj, ts, lsr, pb, jn, blt, fb, jec, hs, jr, ps, and sc) mapped, interpreted, and summarised the data. initially, a thematic framework was developed through discussion among them and with senior study researchers. each researcher was assigned a portion of the data (normally one or more themes) and asked to summarise all data in the framework matrix relevant to that theme into narrative and tabular summaries. they returned to original sources if summaries were unclear or very limited. these were then discussed, further synthesised and combined to produce the results below and in the supplementary report (section ). we found relevant sources, including articles from the published literature databases, from web searches focused on relevant organisations, and from search engines: sources are listed in the linked mendeley repository [ ] . non-english language articles were identified through translated searches. further articles were identified through expert recommendation and tweets. included articles were english (n = ), chinese (n = ), french (n = ), german (n = ), italian (n = ) and spanish (n = ). table summarises included article characteristics. detailed summaries for each theme are in our supplementary report (section ): here we provide an overview. we focus first on reports regarding impacts of the pandemic on people living with mental health problems and individual strategies for coping, then on impacts on the mental health care system and adaptations and innovations put in place. similar themes appeared to emerge across countries and types of source, so all are reported together. any peerreviewed papers reporting data are identified below; position papers, editorials and other work describing perspectives and experiences of scientists rather than data are synthesised along with other sources. most sources on this topic gave narratives and personal observations regarding deteriorating mental health (supplementary report, table ), but a handful of surveys had been conducted among people with mental health conditions (supplementary report, table a ). a survey of young people with mental health needs, and two surveys of adults with mental health problems, all carried out for uk mental health charities, found that around four out of five respondents described experiencing increased mental health difficulties following the onset of the pandemic [ ] [ ] [ ] . the survey of young people reported high levels of anxiety and impulses to self-harm in the week in which schools closed in england. a report from a survey focused on financial impacts elicited self-reports of poorer wellbeing in adults with mental illness being linked to current financial and employment concerns [ ] . a further survey carried out by an academic organisation and a charity again elicited many self-reports of worsened mental health very early in the pandemic [ ] . a usa research study in pre-print showed self-reports of worse mental health in the majority of adults with mental illnesses, with only approximately one in ten feeling that they were coping well with the situation [ ] . in a small published chinese study, hao and colleagues found that service users were experiencing more severe mental health symptoms than the general population at the peak of the crisis in china [ ] . we found no longitudinal surveys, and only the small chinese study included a control group. many sources reported observations from clinicians or self-reports of negative impacts on pre-existing mental health conditions. mechanisms suggested for this included increased anxiety and fear of illness and death directly related to covid- ; impacts of "lockdowns" and social distancing policies, especially of isolation; interactions between symptoms of mental health problems and current public events and concerns; impacts of loss of support from health and other services; and effects of increased social adversities, such as domestic abuse, family conflict or loss of employment. some accounts described impacts on specific mental health conditions, while others simply described an overall negative impact. some conditions have been the focus of numerous and detailed narratives. among people with depression and anxiety, sudden loss of the routines and activities that help people keep well, loneliness and isolation, and increases in health anxiety related to covid- are recurrently identified as exacerbating factors. many articles on obsessive compulsive disorder (ocd) described struggles with requirements for hygiene that contradict usual strategies for managing ocd and intensification of obsessional thoughts about contamination or infection. regarding people with eating disorders, we found many reports that loss of eating and social routines, disrupted access to food and the increased societal prominence of food seem to exacerbate some people's symptoms. one survey of service users with eating disorders found that % reported worsening of symptoms during the first weeks of lockdown in spain [ ] . negative impacts on mental health conditions were described alongside resilience in adversity and even some positive experiences of the pandemic period (see below). several scientific and media articles predicted a rise in suicide. however, an international collaboration of suicide experts argued this should not be accepted as an inevitability, but mitigated through urgent development of suicide prevention strategies [ ] . a few sources also described exacerbation of mental health problems as people replace usual coping strategies with more problematic ones, such as alcohol and substance use or gambling. the pandemic has resulted in extensive and sudden social changes and new risks, some with particular relevance to people living with mental health problems. we mapped the following themes: many sources described loneliness, social isolation and loss of usual activities, and the negative impacts of these on mental health. many people with mental health problems rely on the stability of routines and social contacts to manage their mental health condition, feel connected, and detect signs of deterioration. loneliness was described as arising both from general restrictions on activities and contacts, and from sudden closure of services, including therapeutic sessions and groups, which had been sources of highly valued contacts. patients in inpatient settings have been particularly affected by suspension of visits and leave, sometimes leading to extreme isolation and loneliness, especially when compounded by requirements to stay in hospital rooms and cancellation of ward activities. negative impacts from closure or restriction of a range of services were frequently discussed (see also below for discussion regarding service-level changes). some individuals reported abrupt termination or interruption of their treatment, or the replacement of face-to-face appointments by brief check-in phone calls. others reported being unable to access care for new difficulties, or the postponement of periods of psychological therapy that were about to begin. some sources described feeling abandoned, with a lack of access to information about how to seek urgent help if needed or about when care might resume. remote care was not always seen as sufficient, due to lack of access to or ability to use technology, lack of privacy to engage in remote appointments, and more superficial therapeutic contacts. interruption to medication access and adherence was also reported by several sources, including disruptions to supply or to in-person contacts required to prescribe, monitor side effects and toxicity, and administer medication. some sources reported deterioration in mental health in the context of cessation of medication or lack of monitoring or care. a common theme was that "we are not all in this together", with covid- risks magnifying existing inequalities and creating new ones [ ] . thus covid- and accompanying restrictions were seen by some sources as disproportionately affecting those already experiencing health and social inequalities, through economic impacts, the greater hardships of social restrictions in poor living circumstances, and the withdrawal or restriction of services disproportionately relied on by more deprived populations. withdrawal or reduction of services has been described as resulting in substantially more pressure for families and carers to support service users and manage distress and behavioural difficulties. some families with caring responsibilities have reported feeling abandoned by services, especially in the context of the stresses and greater isolation associated with the "lockdown". meanwhile, some service user accounts expressed worry about 'burdening' relatives by relying on them during the lockdown, or about risks of infecting relatives with covid- , particularly those at greater risk of severe illness. there were also some positive descriptions of enhanced relationships with family and friends during this period, especially by keeping in touch more online or by phone, and some had moved in with family and become closer as a result. a widely expressed concern regarding families shut in together related to the risk of increased conflict, aggression, and violence between household members and especially towards children: many sources expressed concern about this, while a smaller number described relevant incidents. concerns related to people with mental health problems both as victims and as perpetrators. the advice to "stay home" is challenging when home is not a safe space. both current household circumstances and reduced access to police, social services, schools and courts are identified as risk factors for continuing conflict and abuse. seeking help may be difficult if abusers are in constant proximity. sources argued that systems of care and outreach need to be provided for at-risk populations, potentially including communication of these via social media. we did not find sources on the extent of covid- infection among people with mental health problems, or whether rates of infection, or of severe consequences of infection, differ from the general population, nor were there many individual narratives regarding the experience of covid- infection among people with mental health problems. there were some accounts of outbreaks of infection in hospital and residential settings and of service problems that might contribute to these, for example in the usa, china and italy (see below regarding inpatient service challenges). many authors noted that co-morbidity between mental and physical health problems, and lifestyle factors (drug and alcohol use, obesity or, in the case of eating disorders, malnutrition), may result in potentially greater risk of infection and of severe consequences of infection. particular concerns were raised regarding people living in poor housing and confined, crowded, or chaotic environments, such as prisons, inpatient or residential settings, or the homeless mentally ill, as hygiene, infection control, and physical distancing practices are likely to be especially challenging. some reports relate to people with mental health problems experiencing "dual stigma" in terms of additional barriers to accessing physical healthcare: concerns related to quality of treatment for covid- infection in psychiatric hospitals are discussed below. while negative reports exceeded them, some positive aspects of life during the pandemic were described in first person accounts, and via clinicians. some people drew comfort from feeling that everyone was "in the same boat": that people were experiencing a "shared trauma" or that the rest of society was now experiencing similar challenges to the ones they faced day-to-day, such as social isolation or anxiety, and so have greater empathy. feelings of decreased marginalisation, greater acceptance by wider society, and increased levels of community and solidarity were reported. for others, the focus on the pandemic distracted them from their pre-existing conditions, with some reporting fewer symptoms. second, some described being able to mobilise existing reserves of resilience and coping skills during the pandemic, sometimes resulting in an increased confidence. finally, there were many reports of people taking advantage of innovations in remote and digital support and the increasingly widespread use of video calls for communication, support and social contact. these were particularly valued by people for whom difficulties such as physical mobility, social anxiety or paranoia impede face-to-face contacts. many publications describe strategies that people with preexisting mental health conditions have used to manage their mental health and social stresses during the pandemic. a pressing need for many has been to try to replace the activities, routines and contacts that usually support self-management. reported self-management strategies in the pandemic have included engaging in purposeful, creative or relaxing activities, such as cooking or painting, or keeping journals to record worries or positive experiences. use of therapeutic and self-help techniques, such as mindfulness, exposure therapy or meditation, was widely reported, though some found these of limited usefulness given current challenges. others have sometimes found helpful self-management tools and resources, including helplines, online therapy services, websites, podcasts and apps. the importance of maintaining a positive attitude, of selfacceptance and of not putting oneself under pressure was widely expressed. looking after one's physical health, such as taking regular exercise and healthy eating, maintaining a daily routine, and keeping in contact with trusted friends and family members, was emphasised in many sources. a number of people, particularly those with anxiety, reported attempting to avoid or substantially reduce their consumption of potentially stressful or triggering media coverage of the pandemic, relying instead on official or other trusted sources. several sources described types and impacts of practical and emotional support among peers. this included mutual support and practical help, such as collecting medication. sharing experiences and stories of mental health management, coping strategies and positive adaptations featured. digital and online approaches to delivering support had been proactively and creatively deployed in some peer networks to facilitate one-to-one, group and community connections and activities (including recreation and socialising). communicating and connecting were considered vital for reducing social isolation in lockdown, managing mental health, and maintaining relationships with friends, family and peer support networks. the importance of connecting with others in inpatient settings during the pandemic was also mentioned. mutual aid among peers appeared to have positive wellbeing benefits for those offering support. table ) reports based on official data were not generally available at this early stage, but several sources included reports from service managers and clinicians regarding service activity. most reported reduced referrals and presentations to community mental health services, emergency departments and psychiatric wards in the early phases of the pandemic, though one italian source described a subsequent rise. potential explanations included service users' fears of infection, beliefs that help would not be available, or wishes not to burden services. meanwhile, large increases were reported in several countries in use of relevant helplines and, in the usa, a rise in prescriptions for mental health medication. in inpatient settings and supported housing where people live together, immediate concerns were with preventing the spread of infection while attempting to maintain a therapeutic environment. regarding immediate infection control, clinicians' reports from several countries described a lack of protective equipment, an inability or unwillingness of some patients to adhere to protocols, and difficulties with distancing due to ward and office layouts. lack of realistic guidance specific to mental health settings was recurrently reported. lack of expertise or facilities to treat people with covid- effectively was identified as a challenge in providing equitable care, especially where pressure was reported to treat people with mental health problems and covid- as far as possible within psychiatric hospitals. a tension was frequently reported between providing good quality mental health care and infection control, with many inpatients confined to their rooms much of the time with limited face-to-face contacts and little access to advocacy, group-based therapeutic activity or trips into the community. the most frequently reported inpatient adaptation to meet these challenges was the creation of covid- specific units for psychiatric patients with confirmed or suspected illness, often with support from physical health care professionals and protocols in place for transfer to intensive care if needed. other infection control measures included quarantine following admission, early discharge and initiatives to reduce admissions, staggered mealtimes and reduced use of communal spaces. an innovation described by several sources was enhanced use of technology to enable remote contact with healthcare professionals for therapy during hospital admissions, and with families to maintain social contact. in some settings, depending on current national restrictions, group therapy sessions and external visits were maintained with use of personal protective equipment (ppe) and physical distancing protocols. although supported housing settings face some similar challenges to inpatient units, we found few reports about these. the predominant challenges reported in community settings were the need to reduce face-to-face contact and to cope with reduced capacity due to staff absence, diversion of resources to covid- wards, and reduced community resources in general. settings where service users mingle (e.g. day services) tended to have closed, and in some regions, for example of spain and italy, all but urgent response appeared to have closed at the onset of the pandemic, diverting resources to physical healthcare. however, a more usual response around the world appears to have been maintaining community service provision, but with much more restricted face-to-face contact. for the face-to-face working that has continued, poor access to ppe and lack of clear infection control procedures featured in reports from community mental health settings in several countries. telehealth tools appear to have been rapidly implemented in community mental health services across the globe, allowing care to continue at least to some extent. video calls are used both for staff meetings and patient contacts, with some innovative use for group and activity programmes. the use of digital tools such as apps and websites for therapy appears to have also increased, but was less discussed. this shift to telemedicine appears to be welcomed for use in some contexts by many clinicians and service users, who expect this to outlast the pandemic. however, important impediments and limitations were that some service users lacked technological access and expertise, or privacy for calls; poor technology resources in services; and potential negative impacts on rapport and therapeutic relationships. the voices of the digitally excluded are particularly likely to remain unheard. several challenges were identified in maintaining professional values and human rights during the pandemic. these especially-although not exclusively-centred on inpatient psychiatric settings. some sources, especially from france, argued that access to physical health care (for covid- ) is inequitable for mental health service users, and that they may receive poorer quality health care, due to stigma and to a policy of treating them as far as possible in psychiatric units rather than general hospitals. there were also concerns that mental health care may become less ethical during the pandemic, with clinicians and service users in various countries reporting beliefs that medication doses and the use of sedation have increased, or that coercive and restrictive practices which impact rights and freedoms may be rising, especially in wards with compromised therapeutic environments and access to advocates. though they have not as yet been put into practice, the provisions in the emergency coronavirus act in england and wales were reported to have caused great concern by potentially allowing involuntary admission decisions to involve fewer healthcare professionals, extending time limits on detention and facilitating the use of treatment without consent. reduced access to legal representation and advocacy was also reported. the final theme concerned fears and expectations about the future. internationally, a delayed wave of increased need for services was widely anticipated, potentially combined with reduced resources to meet this, especially where services are already underfunded. the potential long duration and fluctuating nature of the pandemic was also a concern: coping strategies may not be sustained at individual or service levels. we summarise here the first reports regarding the impact of the covid- pandemic from a wide variety of sources, mapping the impacts, concerns, experiences and responses at an early stage from a variety of perspectives and locations, focusing on recurrent themes. reports suggest that individuals with mental health problems have much to cope with: pandemic fears and circumstances interact with some symptoms; routines, contacts and activities that people have developed to manage their mental health have been shattered; and loneliness and social isolation are more prevalent. the risk that social adversities and existing inequalities may get worse is very concerning. while the current situation is new, these reports are congruent with findings of persisting negative psychological and socio-economic impacts arising from previous epidemics [ , , ] . however, the narratives we examined also caution against making assumptions about impacts, as responses to the pandemic clearly vary. many people with mental health problems are unfortunately used to isolation and adversity: this may result in resilience and abilities to manage challenges actively and to draw on peer and community support. initiatives that support them in this are potentially valuable. regarding service impacts, the immediate wave of increased activity predicted by some seems not to have occurred in the early weeks of the pandemic, or to have shifted to services such as helplines. however, a later surge of activity is widely expected. currently, some of the most pressing concerns relate to inpatient and residential care settings. in these environments, there are both specific and immediate challenges regarding infection control, with severe potential consequences for failure, and a pressing need to combine infection control with maintaining a therapeutic environment, safeguarding patient rights, and avoiding isolation in hospital. rapid research to investigate and compare strategies to address these challenges would be valuable. in the community, reports of telehealth having been swiftly adopted are striking given that implementation of innovations in health services is often observed to be slow [ ] : both clinician and service user responses suggest it may well endure after the pandemic. adoption of telehealth has previously been slow in many countries, despite evidence that it can be an effective, cost-effective and acceptable approach to reducing treatment gaps and improving access to mental health care for service users, especially where access is otherwise limited [ ] [ ] [ ] . we suggest that an urgent task now is to further co-produce, test and implement promising telepsychiatry initiatives so that they are as effective and acceptable as possible, drawing on already available guidance and evidence. [ ] . barriers need to be addressed, the most appropriate technologies identified, and both staff and service users supported in their use. meanwhile, the limitations of these technologies and the need to be selective in their use also need to be recognised, especially where continuing use following the pandemic is contemplated. a range of legal, regulatory, organisational and cultural challenges will also need to be addressed [ , ] . our search was wide ranging, achieving our aim of capturing many perspectives from many types of source and country: however, it will not have been comprehensive. we have compressed a large amount of material into a small space to ensure that it is useful (our supplementary report provides much more detail). although we encompass multiple countries and languages, our scope is not global, and most notably includes few reports from low-or middle-income countries. many of the sources were identified using web search engines. search results from these are influenced by factors such as time of day and ip address, limiting replicability and comprehensiveness. our english search strategy was more extensive than for other languages, especially because english-speaking experts contributed additional sources. people with experience of using mental health services and mental health clinicians were involved in many ways with this research, but day-to-day management was mainly by academic researchers not currently using or working in services. we adopted a rapid qualitative process for coding and summarising the data [ ] , not including substantial double coding: experienced researchers checked each coder's first summaries, and during the summarising process, we returned to sources where there was inconsistency or lack of clarity, but it is likely that ideas and themes were missed. our process was primarily deductive and based on a positivist paradigm, although discussions amongst team members with qualitative analysis experience, and use of narrative summaries, helped to retain the inductive spirit of qualitative analysis within a large and rapid analytic process. as yet, relevant scientific data are few. we have grouped together narratives and observations from all other types of sources on the basis that when scientists are reporting views, experiences and predictions rather than research findings, these are not necessarily more informative than the experiences of people trying to manage their own mental health problems or of clinicians trying to support them and to maintain services. journalists do not generally follow the same principles of objectivity as scientists, but in a rapidly evolving situation their investigations have the advantages of being quickly carried out and of often reporting on direct contacts with service users and/or clinicians. they may, however, tend to focus on more extreme situations, just as the people with lived experiences or clinicians who write about their experiences are unlikely to be representative. their swiftly written reports do, however, provide a rich and varied corpus of material through which we can understand the range of early experiences, responses, knowledge and practice among people with pre-existing conditions and in the services that they use. with this work, we have created an early map of impacts and responses from the covid- pandemic that identifies areas requiring service and policy response, and many potential areas for future investigation. we note, however, that the current crisis is evolving rapidly, and suggest that while some concerns are likely to be consistent, it will be essential to continue to review needs, challenges and the success of responses, as much is likely to change. this study assimilated international and grey literature written in several languages. despite the inclusion of a wide variety of sources, there is an absence of discrete minority group perspectives and sources focusing on the disproportionate impact of covid- on bame (black, asian and minority ethnic) groups in particular. the synthesis touches on the denial of liberties of people with mental health problems but research is yet to explore aspects of urgency and emotionality around this issue or the effects of this as a secondary response. deprivation of rights from a fear that people cannot adequately socially distance, reducing the number of clinicians required to admit people under the mental health act and inequalities of treatment for those with mental health problems who have covid is unacceptable and worthy of future scrutiny. safety relating to mental health environments was omitted. given the challenges of segregation without the unethical use of sedation and solitary confinement, attention should be directed towards ward design to minimise contagion. regarding people's ability to self-manage, it is unclear to what extent this can be framed as 'resilience' in circumstances with few other options, and what can be maintained without support. others may only opt to self-manage from fear of infection or concern about being burdensome to an overwhelmed nhs. reported satisfaction with virtual consultations naturally omits the voice of those unable to participate, and so conclusions should be viewed with caution. digital exclusion is real and complex. issues raised in the paper-a triple whammy of poorer service, loss of rights (both informal and state sanctioned e.g. coronavirus act) and the reduced access to advocacy or legal services also have an aggregate relationship. the complexity of this effect requires deeper qualitative research. going forward, it is vital to understand the long-term mental health consequences that pandemics have on different intersections of society. this is an independently written perspective from lived experience contributed by some of the co-authors with relevant experience. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creat iveco mmons .org/licen ses/by/ . /. factors associated with mental health outcomes among health care workers exposed to coronavirus disease covid- : results of a national survey of united kingdom healthcare professionals' perceptions of current management strategy-a cross-sectional questionnaire study the covid- pandemic, financial inequality and mental health covid- and mental wellbeing the psychological impact of quarantine and how to reduce it: rapid review of the evidence psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the covid- pandemic a global needs assessment in times of a global crisis: world psychiatry response to the covid- pandemic multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science covid- pandemic: impact on psychiatric care in the united states, a review online mental health services in china during the covid- outbreak rapid reviews to strengthen health policy and systems: a practical guide using framework-based synthesis for conducting reviews of qualitative studies using the framework method for the analysis of qualitative data in multi-disciplinary health research full bibliography numbered-mh pru covid- international document analysis. mendeley data v % of people living with mental illness say current crisis has made their mental health worse hafal survey raises concerns about the provision of mental health services in wales during the covid- outbreak. survey raises concerns about the provision of mental health services in wales during the covid- outbreak money and mental health at a time of crisis survey results: understanding people's concerns about the mental health impacts of the covid- pandemic covid- concerns among persons with mental illness (pre-print) do psychiatric patients experience more psychiatric symptoms during covid- pandemic and lockdown? a case-control study with service and research implications for immunopsychiatry covid- and implications for eating disorders suicide risk and prevention during the covid- pandemic covid- can have serious effects on people with mental health disorders stress and psychological distress among sars survivors year after the outbreak long-term psychiatric morbidities among sars survivors review of key telepsychiatry outcomes the empirical evidence for telemedicine interventions in mental disorders a systematic review of the use of telepsychiatry in acute settings guidance on the introduction and use of video consultations during covid- : important lessons from qualitative research the use of telepsychiatry during covid- and beyond telepsychiatry and the coronavirus disease pandemic-current and future outcomes of the rapid virtualization of psychiatric care fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science rapid qualitative research methods during complex health emergencies: a systematic review of the literature luke sheridan rains · sonia johnson , · phoebe barnett · thomas steare · justin j. needle · sarah carr , · billie lever taylor · francesca bentivegna · julian edbrooke-childs · hannah rachel scott · jessica rees · prisha shah · jo lomani , · beverley chipp · nick barber · zainab dedat · sian oram · nicola morant · alan simpson , on behalf of the covid- mental health policy research unit group key: cord- - a bor authors: negrini, stefano; donzelli, sabrina; negrini, alberto; negrini, alessandra; romano, michele; zaina, fabio title: feasibility and acceptability of telemedicine to substitute outpatient rehabilitation services in the covid- emergency in italy: an observational everyday clinical-life study date: - - journal: arch phys med rehabil doi: . /j.apmr. . . sha: doc_id: cord_uid: a bor abstract objective to investigate the feasibility and acceptability of telemedicine as a substitute of outpatient services in emergency situations like by the sudden surge of the covid- pandemic in italy. design observational cohort study with historical control. setting tertiary referral outpatient institute. participants consecutive services provided to patients with spinal disorders. interventions telemedicine services included teleconsultations and telephysiotherapy. they lasted as long as usual interventions. they were delivered using free teleconference apps, caregivers were actively involved, interviews and counselling were performed as usual. teleconsultations included standard, but adapted measurements and evaluations in video and from photos/videos sent in advance according to specific tutorials. during telephysiotherapy, new sets of exercises were defined and recorded as usual. main outcome measure(s) we compared the number of services provided in three phases, among them and with corresponding periods in and : during control ( working days) and covid surge ( days) only usual consultations/physiotherapy were provided, while during telemed ( days) only teleconsultations/telephysiotherapy. if a reliable medical decision was not possible during teleconsultations, usual face-to-face interventions were prescribed. continuous quality improvement questionnaires were also evaluated. results during telemed, teleconsulations and telephysiotherapy sessions were provided in days. we found a rapid decrease (- %) of outpatient services from control to covid phase (r = . ), partially recovered in telemed for telephysiotherapy (from - % to - %; p< . ), and stabilised for teleconsultation (from - % to - %) interventions. usual face-to-face interventions have been needed by . % of patients. patients’ satisfaction with telemedicine was very high ( . / ) conclusion(s) telemedicine is feasible and allows to keep providing outpatient services with patients’ satisfaction. in the current pandemic, this experience can provide a viable alternative to closure for many outpatient services while reducing to a minimum the need of travels and face-to-face contacts. telemedicine is feasible and allows to keep providing outpatient services with patients' satisfaction. in the current pandemic, this experience can provide a viable alternative to closure for many outpatient services while reducing to a minimum the need of travels and face-to-face contacts. keywords telemedicine, telerehabilitation, outpatients, covid- , epidemic j o u r n a l p r e -p r o o f faced it with a total quarantine of the affected areas to eradicate the virus. italy, and now most of other countries, adopted a partial quarantine to mitigate the epidemic. this strategy aims to decrease the heavy impact on the health systems and allow hospitalization and intensive care of the huge number of patients in need, reducing the overall mortality. the covid- emergency is hitting hard not only infected patients but also all the others. in many countries, outpatient services have been fully closed due to the need of physicians for and to reduce the risk of infection due to travels. consequently, outpatients are on their own and mostly self-managing. this is not acceptable for diseases that can still have sudden, important progressions even in a few months, and even less acceptable in children. all these could become collateral damages of the covid- emergency. telemedicine is defined as the exchange of medical information using electronic tools. it has multiple applications and can be used to provide different services, including consultations and physiotherapy. telemedicine has shown to be effective in specific areas of care, particularly where technology is involved or medical "hands-on" techniques are less important. to our knowledge, there are no published results about the application of telemedicine to patients with spinal deformities. in front of the sudden covid- emergency in italy, and the mobility restrictions to the population, to continue to provide our outpatient services (including hands-on physiotherapy and medical evaluations) we have been forced to convert completely to telemedicine, rapidly developing specific ad-hoc solutions. we are not aware of studies about such a total conversion, for neither medical consultations (teleconsultations) nor physiotherapy sessions (telephysiotherapy). the aim of this paper is to report the feasibility and acceptability of telemedicine as a substitute to usual tertiary referral outpatient rehabilitation services. we looked at the numeric impact on services of ( ) the or partial lockdown, as well as other conditions precluding transportations. italy discovered to have an epidemic of covid- under way on february th , and immediately red zones (total quarantine) were imposed close to milan. this did not reflect straightaway on the services provided, but the weekly crescendo of partial quarantine throughout the country, with closure of schools on march the nd and travel restrictions on the th drove to a clear drop of services ( figure a ). this reduction, and the safety needs of patients and health professionals, urged the decision to move all activities of our institute to telemedicine on the same day of prime minister's decree to shut down all commercial activities (march th ). on the th , all usual face-to-face services were stopped, unless required following telemedicine. the setting is a tertiary referral outpatient rehabilitation institute for spinal deformities, specialised on pediatric health conditions. the institute usual services include face-to-face consultations, physiotherapy (evaluation, exercises teaching, cognitive-behavioral approach and counselling) and psychological sessions, with brace fitting provided in orthotics facilities. starting from a few previous telephysiotherapy feasibility experiences, we developed in a few days and started in emergency brand-new protocols, by discussion and consensus among the most experienced physiotherapists and physicians. the protocols were discussed and agreed on by all the other professionals in meetings, that were repeated weekly during the study. supervision was provided to all professionals. a few adaptations to the original protocol were performed in the first week. the telemedicine service has been offered to all our patients aged between and . for this analysis, we retrospectively included all services provided from january th , to april rd , . telemedicine interventions (table ) have been delivered using free teleconference apps (skype™, whatsapp™ and goniometers). these were received before the telemedicine sessions. all telemedicine sessions lasted as long as usual. clinical history, conclusions and counselling were performed as usual. teleconsultations innovations included measurements of the photos/videos previously provided using the software surgimap™, that were confirmed by "live" measurements repetition under direct medical guidance. telephysiotherapy sessions innovations included teaching of exercises using the hands of parents under physiotherapist guidance, and the usage of normal house furniture as treatment tools. we considered phases: ( ) control: usual services prior to discovery of covid- spread (creation of "red zones"), working days (january th to february rd ); ( ) satisfaction with services provided was evaluated at the quality continuous improvement questionnaires, while all professionals were closely monitored throughout the period with supervision, and email consultations. at the end of the study period they were asked to send their positive and negative comments on the experience. the variation of the provided services in total, and in groups (physiotherapy and consultations, the last divided in sub-groups: first visits, follow-ups and brace checks) were compared in the phases among them in , and with the same periods in the years and . we considered the explanatory categorical -level variables years and phases. we checked differences between and within the variables through a two-way anova, a post hoc analysis with scheffe correction for significant differences, and marginal means. we also performed a regression analysis within each phase to check the influence of days on services provided. we used stata and excel. during telemed, in weeks ( working days), physicians and physiotherapists provided , interventions ( teleconsulations, telephysiotherapy sessions). we found in , but not in and , a rapid decrease of outpatient services in covid phase (- %) in both groups (- % physiotherapy sessions, - % consultations). we also found differences among phases in (table ) : comparing to the great losses from control to covid, during telemed physiotherapy recovered (from - % to - %; p< . ), while consultations did not. for consultations there were differences among sub- groups: follow-up teleconsultations stabilised (from - % to - %), while first visits (from - % to - %) and brace checks (from - % to - %) almost disappeared ( figure b) . the regression describes well the day-by-day effect of covid- and telemedicine within the phases: all services and physiotherapy subgroup decreased in covid phase (p< . ; r = . and . , respectively), and consultations increased in telemed (p< . ; r = . ) ( figure c ). during telemed, . % of patients were required by physicians, after the teleconsultation, to move from home to reach our institute for a usual face-to-face consultation. quality continuous improvement questionnaires (response rate %) reported a mean satisfaction of . out of . all physicians and therapists have been very happy with their experiences, confirming that it was possible to work properly. those less used to technology declared surprise and great satisfaction with the services delivered. the covid- pandemic started in china currently has its epicentre in europe and it's quickly spreading. italy was the first country hardly struck by covid- after china, with the public health system struggling to react. outpatient services were shut down to move the staff to covid- services. in previous epidemic emergencies, a dramatic reduction of public services has been documented too. nevertheless, this pandemic is posing unique challenges to the health systems worldwide. it is clear that a major need is to guarantee a continuum of care to other patients unaffected by the virus, while at the same time protecting them from possible contact with it, avoiding travels and access to health facilities. despite the unavoidable limits due to its observational nature and the use of an historical control, this first study shows the possibility to completely transform also classical "hands-on" outpatient services to telemedicine in the covid- emergency. in this way, we reduced below % the needs for travels and access to health facilities for patients, and zeroed travels of health professionals. this experience can provide a viable alternative for many outpatient services, avoiding their closure with the consequent impact not only on patients' health but also economical on professionals and facilities. the current study has limitations but also strengths. it has high ecological validity: real life, a whole institute, over , interventions; it is unique: the pandemic allows to study emergency situations, the sudden total change of all activities offers insight on feasibility and acceptability in these circumstances. there are risks of selection bias: patients feeling urgent need for consultations, or more severe cases could digital knowledge) can have precluded a specific population to access the services; some patients cancelled the session because they did not feel comfortable in the preparation phase (table ) evolution during the days of services (grey), consultations (blue) and physiotherapy (orange) in covid- and telemedicine phases. table . differences between usual (consultations and physiotherapy) and telemedicine (teleconsultations and telephysiotherapy) interventions. table . average variations (anova) in services provided in the studied phases, including consultations and physiotherapy subgroup. during control and covid only usual consultations and physiotherapy were provided, while during telemed only teleconsultations and telephysiotherapy -see text for more details. table . average variations (anova) in services provided in the studied phases, including consultations and physiotherapy subgroup. during control and covid only usual consultations and physiotherapy were provided, while during telemed only teleconsultations and telephysiotherapy -see text for more details. covid- : towards controlling of a pandemic. the lancet how will country-based mitigation measures influence the course of the covid- epidemic? critical care utilization for the covid- outbreak in lombardy italy: early experience and forecast during an emergency response covid- and italy: what next? the lancet at the epicenter of the covid- pandemic and humanitarian crises in italy: changing perspectives on preparation and mitigation. catalyst non-issue content rehabilitation for children and adolescents in europe standards of management of idiopathic scoliosis with corrective braces in everyday clinics and in clinical research reduced vaccination and the risk of measles and other childhood infections post-ebola key: cord- -z l tsir authors: johnson, sonia; dalton-locke, christian; vera san juan, norha; foye, una; oram, sian; papamichail, alexandra; landau, sabine; rowan olive, rachel; jeynes, tamar; shah, prisha; sheridan rains, luke; lloyd-evans, brynmor; carr, sarah; killaspy, helen; gillard, steve; simpson, alan title: impact on mental health care and on mental health service users of the covid- pandemic: a mixed methods survey of uk mental health care staff date: - - journal: soc psychiatry psychiatr epidemiol doi: . /s - - - sha: doc_id: cord_uid: z l tsir purpose: the covid- pandemic has potential to disrupt and burden the mental health care system, and to magnify inequalities experienced by mental health service users. methods: we investigated staff reports regarding the impact of the covid- pandemic in its early weeks on mental health care and mental health service users in the uk using a mixed methods online survey. recruitment channels included professional associations and networks, charities, and social media. quantitative findings were reported with descriptive statistics, and content analysis conducted for qualitative data. results: , staff from a range of sectors, professions, and specialties participated. immediate infection control concerns were highly salient for inpatient staff, new ways of working for community staff. multiple rapid adaptations and innovations in response to the crisis were described, especially remote working. this was cautiously welcomed but found successful in only some clinical situations. staff had specific concerns about many groups of service users, including people whose conditions are exacerbated by pandemic anxieties and social disruptions; people experiencing loneliness, domestic abuse and family conflict; those unable to understand and follow social distancing requirements; and those who cannot engage with remote care. conclusion: this overview of staff concerns and experiences in the early covid- pandemic suggests directions for further research and service development: we suggest that how to combine infection control and a therapeutic environment in hospital, and how to achieve effective and targeted tele-health implementation in the community, should be priorities. the limitations of our convenience sample must be noted. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. been launched, there has been less focus on the needs of people already living with mental health conditions, and on how mental health services are supporting them at a time of potential staff shortages and service reconfigurations [ ] . potential risks to provision of mental health care worldwide include staff absences due to sickness and the need to self-isolate, and workforce redeployment, for example from community to inpatient settings. in the community, staff in many countries have been required to limit face-toface contacts to essential tasks such as the administration of injectable medication [ ] . beyond the immediate changes to services seen in the early stages of the pandemic, there are many potential challenges that are specific to mental health care. these include difficulties in implementing infection control and social distancing guidance in settings where people may be very distressed or cognitively impaired [ ] , especially in mental health wards and the supported accommodation settings where many people with complex mental health problems live [ ] . face-to-face meetings are usually central to mental health care: severe restrictions to this seem likely to greatly alter staff and service user experiences. there is also a considerable risk that, even after restrictions are lifted, there will be a lasting exacerbation of health and social inequalities that affect people with longer term mental health problems, for example, through increased economic disadvantage, inequalities in health care, or sequelae of increased trauma and abuse [ , ] . since the start of the pandemic, experts from around the world have published views about potential negative impacts of the pandemic on mental health services [ , , ] and the suggestion has also been recurrently made that it could provide an opportunity for positive service developments [ ] [ ] [ ] . however, there is a lack of research directly assessing and reporting the experiences and perspectives of those currently working in the mental health system. our aim was to inform further research and service responses by conducting, in the early stages of the covid- pandemic, a survey of the perspectives and experiences of staff working in inpatient and community settings across the uk health and social care sectors. the king's college london research ethics committee approved this study (mra- / - ) , which involved mental health staff in the uk completing an online questionnaire. in the absence of a measure of pandemic impact on mental health care and mental health service users, we rapidly developed an online questionnaire to collect cross-sectional quantitative and qualitative data from mental health care staff. all staff working in face-to-face mental health care in the uk, or managing those who provide such care, were eligible to participate. all specialties were included, as were nhs, private healthcare, social care, and voluntary sector services. the lead developer of the questionnaire, sj, an academic and practising inner london psychiatrist, read key sources identified in an accompanying rapid review of relevant literature [ ] , including academic and professional journals, news media, and organisational websites, and followed relevant social media topics. the drafting of the questionnaire was further informed by the nihr mental health policy research unit (pru) working group for this study (about people, including clinicians, researchers, and people with relevant lived experience), and the pru lived experience working group. both groups discussed the study at online meetings and identified important topics for inclusion. nine further clinicians provided email summaries of the challenges which they were currently facing and how they were being addressed. feedback was obtained from the pru working group on a first draft of the questionnaire, together with additional input from experts in fields including mental health care for older people, children and adolescents, people with drug and alcohol problems, offenders, and people with intellectual disabilities. the questionnaire was revised and converted into an online format using the ucl opinio platform. pilot testing was then conducted with clinicians, who provided feedback on length, acceptability, and relevance, and on problems with specific items. following this, a final version of the questionnaire was agreed. a mixture of structured and open-ended questions was included. participants were asked which sector and region they worked in but not which organisation, maximising anonymity. participants could skip questions if they wished, and internet cookies were used to prevent participants completing multiple questionnaires. a branching structure was adopted, with initial questions asking all participants to rate the relevance of each item on lists of: -challenges at work during the covid- pandemic. -problems currently faced by mental health service users and family carers (from a staff perspective). -sources of help at work in managing the impact of the pandemic. this was followed by sections for staff in specific settings and specialties. questions also elicited details of adaptations and innovations introduced to manage the impact of the pandemic, and their perceived success, and enquired about concerns for the future and any aspects of current practise that they would like to keep after the pandemic. participants were asked between and questions depending on their eligibility for branching questions for specific settings or specialties. depending on the detail provided to open-ended questions, the survey typically took - min to complete. a copy of the survey is available at this web address: https ://opini o.ucl.ac.uk/s?s= . our aim was to achieve rapid recruitment of a large and varied sample by dissemination through multiple channels including: in the final week of recruitment, we targeted under-represented sectors, including relevant voluntary sector organisations and supported housing providers. we also sought to increase representation of staff from black, asian, and minority ethnic groups by focused social media recruitment via the mental elf, including a video in which a prominent black psychiatrist encouraged participation, and contact with the networks of pru researchers who work on issues of diversity. quantitative data: we aimed to give an overview of the impact of the pandemic. we produced descriptive statistics using stata to summarise relevant aspects of the quantitative data. missing data are reported in the footnotes of the relevant tables in the supplementary report. qualitative data: qualitative analysis was conducted to expand on quantitative findings [ ] . a preliminary analytical coding framework was developed by sj guided by the study research questions, quantitative analysis results, and themes emerging from the initial survey responses. the responses to open-ended questions were left unedited and compiled under topics relevant to the research questions. coding matrices were developed in microsoft excel, with the emerging codes in the columns and cases in rows. directed descriptive content analysis was then conducted [ , ] . for this, all survey responses were indexed in the coding matrices by a group of researchers, mostly phd students or researchers with relevant lived experience. topics that came up repeatedly in the data and could not be categorised with the initial coding framework were given a new code. coding work was coordinated by so (associate professor) and nvsj, uf, and ap (post-doctoral researchers) to increase consistency and accuracy when applying the predetermined codes, and to discuss adding codes to the initial framework when necessary. sj and as (clinical professors) helped to understand clinical contexts and resolve coding difficulties. finally, the coding team developed summaries of each code and presented these in tables ranked in order of frequency, shown in the supplementary report. involvement of this large team allowed us to complete analysis within weeks. we summarise key findings here: our accompanying supplementary report gives much more detail. data were collected from april to may . in total, , people started the survey (including many who clicked 'start' but provided no or minimal data) and , got to the end. we report results for participants who completed at least one question from each of the three main sections open to all respondents. this produced a sample of , . there were , responses to open-ended items, yielding , words for rapid qualitative content analysis. a large majority of participants worked in the nhs ( , , . %). approximately a third described themselves as nurses ( , . %), as psychologists ( . %), as psychiatrists ( . %), as social workers ( . %), and as peer support workers ( . %). over a third identified as a manager or lead clinician in their service ( , . %). over two-thirds worked with working age adults ( , , . %), . % worked with older adults ( ), just under a third worked with people with learning disabilities ( , . %), around a fifth worked with people with drug and alcohol problems ( , . %), and another fifth worked with people with eating disorders ( , . %). participants could report working with multiple service user populations and/or in multiple settings. the majority worked in england ( , , . %) with around a third of these based in london ( , . %) and a fifth in the north west ( , . %); three-quarters worked in cities or towns with populations greater than , ( , , . %). four-fifths were female ( , , . %) and almost nine-tenths were from white ethnic groups ( , , . %). full demographic details, including age, caring responsibilities, and covid- status, can be found in table x of the supplementary report (references to tables in the supplementary report are herein indicated with an 'x' after the table number to distinguish them from tables in the main text). participants rated a list of current challenges at work, some general and others setting-specific, on a five-point scale from 'not relevant' to 'extremely relevant'. table shows the five work challenges rated highest in each type of setting; tables x- x report this in further detail. in inpatient wards and crisis houses, infection control challenges, related to table top five rated work challenges* for each setting (see tables x- x and x- x in the supplementary report for further details) * includes 'current work challenges' (c) asked of staff from all settings and 'additional work challenges' (a) that are specific to each service type ** a respondent may work in more than one setting (e.g., an inpatient service and a crisis assessment service), but will provide only one answer per challenge *** the 'additional work challenges' (a) sections, which are specific to specific settings and specialties, appear in the survey after the 'current work challenges' (c) section, which is open to staff from any setting. therefore, the reduced n for a challenges compared to c challenges represents respondents who completed the first sections of the survey, but then did not go on to complete the later branched sections of the survey both service users and staff becoming infected, were rated highest, alongside increased boredom and agitation amongst service users due to lack of activity and contact on the ward. crisis service staff rated as most relevant lack of services to which they could refer on or signpost. community team staff rated items related to changes in ways of working and adoption of remote technologies highest, along with reduced availability of other services. the small group of residential service participants gave a high relevance rating to their environment being more challenging, because residents cannot go out and/or engage in usual activities. table x shows ratings by profession and table x shows ratings by managerial roles. there were fewer obvious differences by profession than by setting, but managers and lead clinicians more often reported challenges relating to supporting colleagues with stressors due to the pandemic, and increased workload during the pandemic as very or extremely relevant ( . % and . %, respectively) compared to those not in these roles ( . % and . %, respectively). half of staff in inpatient and residential settings reported that they could not consistently follow the rules set on infection control ( , . %), and just over a third reported that they could not do this in community and other settings ( , . %). table shows the impediments to this most often identified from qualitative content analysis of responses, with more detail in tables x- x. tensions between meeting clinical needs and infection control were reported across settings, for example in responding to emergencies on wards or when service users in the community needed home visits, on which infection control measures were very difficult to implement. the built environment was the most frequently cited challenge in the community, and ward layouts impeded infection control in hospital. in each setting, there were also reports of conflicting or unclear guidance. reports of not having the facilities and processes to adhere to guidance, for example in putting on and disposing of personal protective equipment (ppe), were especially prominent in the community. unclear or conflicting guidance and procedures, and service users who are unable to understand and adhere to infection control rules, were reported across settings. substantial numbers were also concerned about perceived conflicts between protective equipment and therapeutic relationships, for example when trying to engage service users with paranoid ideas while wearing a mask. we also asked participants to report, if data were available to them, the extent of activity change in the service in which they worked (table x ). responses varied, but reports of reduced activity considerably exceeded those of increased activity, especially regarding inpatient admissions (though less so for compulsory admissions) and new referrals to crisis services and community services. however, in community services, including psychological treatment services, similar numbers of staff said that they were having more weekly contacts as said they were having fewer. table summarises staff perceptions of the current relevance of various types of difficulty for the service users and carers with whom they were in contact (table x reports this in greater detail and by service user group). across all groups, staff tended to rate social difficulties as most relevant, for example, loneliness and lack of usual support from table top five reasons infection control rules could not be followed for inpatient and community settings* (with frequencies), responses to an open-ended question (see tables x- x in the supplementary report for further details) * a respondent may work in more than one setting (e.g., an inpatient service and a crisis assessment service) ** includes staff working in inpatient services, crisis houses, and residential services *** includes staff working in crisis assessment services, community teams and psychological treatment services, community groups, and other settings inpatient and residential settings** community settings*** family and friends. several other types of problem were also rated by many staff as very or extremely relevant, including lack of normal support from mental health and other services, deterioration in mental health in the pandemic period, worries about infection, and being at high risk if infected. responding to open-ended questions, staff identified a range of groups of service users about whom they were particularly concerned, some because of impacts on their clinical condition, others because of their social characteristics or circumstances, or because of specific difficulties providing an adequate service for them. table summarises groups frequently identified as of particular concern, and table x gives more detail. we also asked staff whether they were seeing people with mental health difficulties that appeared to arise from the pandemic (table x) . some described symptoms directly related to covid- , such as delusional beliefs regarding covid- infection or quarantine, and health anxiety or obsessive-compulsive symptoms related to infection. others described relapses in people who had long been stable that they felt were linked to the stresses of the crisis. some also reported apparently first presentations of mental health problems such as psychosis or mania among healthcare workers. table summarises responses to a question about which sources of help were currently most important to staff in managing the impact of covid- at work. across all professions, the most important sources of help were support and advice from employers, colleagues, and managers, closely followed by new digital ways of working and the resilience and coping skills of service users and carers, the latter presumably seen as making the crisis less burdensome for staff, at least at its onset. patterns of response were not markedly different across professional groups (tables x- x). table summary of staff perspectives on which of their service users' and carers' problems are most relevant, in order of % rated very or extremely relevant (n = , ) (see table x participants in crisis and community services were asked whether services they worked in had changed opening hours or locations, and how their practices had changed (table x ). services that had increased their hours during the crisis, for example with weekend opening, were described, as well as reductions in other services. most staff working in crisis services reported that home visits were continuing when strictly necessary. a mixture of responses was obtained from community services (including both community mental health teams and psychological treatment services), with some reporting continuing face-to-face contacts and home visits as needed, others having stopped them. responses regarding psychological treatment were split between aiming to provide a full table frequently cited examples of the groups of service users about whom staff participants have been especially concerned during the pandemic: qualitative content analysis of open-ended responses (see table x in the supplementary report for further details) people who are cognitively impaired (e.g., due to dementia or learning disability), who may find situation hard to understand and struggle to follow guidance people with psychotic symptoms that may be exacerbated by current events and interfere with their ability to follow guidance people with complex emotional needs (who may have a "personality disorder" diagnosis), who may be destabilised by abrupt loss of support and routines; people with anxiety or ocd, especially those for whom covid- interacts with contamination-related symptoms women with perinatal mental health problems, lacking usual support and assessment around the time of birth people with drug and alcohol problems, for whom treatment and support are often severely disrupted and following guidance may be difficult people with eating disorders, at risk from disruption to usual eating, exercise, and social routines and to food access people of concern due to impacts related to social circumstances or characteristics people who live alone/are currently socially isolated and lonely older people with mental health problems, due to loss of usual support (e.g., family visits) and additional physical health vulnerability people who are in households where there is domestic violence or conflict children in homes that may not be safe or where there is family conflict people living in poverty/poor housing, or who are homeless, for whom the lockdown is especially difficulty people of particular concern due to service disruptions inpatients who have experienced service disruptions, including precipitate discharge, delayed discharge because of infection concerns, lack of leave or visits, and increased isolation and lack of activity or therapies on the wards people who are difficult to reach in the community without usual visiting/outreach/face-to-face appointments and may not be seeking help that is needed people at risk because of disrupted availability of medical responses, e.g., for people who harm themselves and are discouraged from visiting/ reluctant to visit emergency departments open-ended questions elicited adaptations and innovations made to manage the impact of the pandemic (table x ). the most widely reported shift was greatly increased adoption of remote technologies, as discussed below. some participants also reported adopting new digital tools for assessment and therapy, such as apps and websites. other innovations included new crisis services, such as crisis assessment centres rapidly established as alternatives to hospital emergency departments and new crisis phone lines, and re-organised services, resulting in extended hours, increased access for specific groups, or shorter waiting lists (e.g., for psychological treatment). reported changes in the types of help offered included community services arranging practical help, such as food deliveries for service users, and providing resource packs to help service users to be active at home. also frequently described were new or expanded forms of support for staff, including 'wobble' rooms (quiet rooms for staff who feel overwhelmed), staff helplines, increased supervision, wellness check-ins, and more use of informal support mechanisms. also reported was a general shift towards a more flexible approach, reducing bureaucracy and removing barriers to change, leading to a more agile way of working and a more responsive service. many staff also valued the many benefits to their well-being, productivity and efficiency in being able to conduct some of their client contact or administrative tasks away from the office. further quantitative and open-ended questions explored views and experiences of the shift to remote working (tables x- x) . almost all staff in community services ( , , . %) , and a large majority in crisis services ( , . %), were replacing some face-to-face contacts with phone or video calls. the shift to video calls did not appear to have been very extensive, however, with the majority ( , . %) reporting use of this technology as their main means of contact with % or fewer of the service users with whom they have contact. views about this were mixed. video calls for communication between staff attracted the greatest enthusiasm, with more than two-thirds ( , . %) from both community and crisis services agreeing or strongly agreeing that they are a good way to hold staff meetings; this was echoed in open-ended questions. a majority ( , . % of respondents to this question) agreed or strongly agreed that video calls were a good way to assess progress of some people already known to the service, but only . % ( ) agreed or strongly agreed that they can be a good way of making the initial assessments. responses to open-ended questions ( table , tables x- x) likewise identified concerns about being able to make a good assessment remotely, as well as about forming rapport: they tended to suggest digital technologies were useful for clients with less complex needs, for "light-touch" interventions or for low-intensity therapeutic approaches and follow-up appointments. a majority ( , . %) agreed or strongly agreed that use of remote rather tables x- x in the supplementary report for further details) what's working well in tele-health what can prevent tele-health from working allows prompt responses saves travelling time is better for the environment may be more convenient for both staff and service users allows staff to connect easily with each other, even if based in different places and different teams allows home working best alternative for now: remote working is allowing services to keep going despite infection control restrictions innovative use of it and digital tools can allow group programmes or individual therapies to continue successfully benefits for some clients: some clients are happy with video-call technology and even prefer it access is improved for some people, especially if travel and public places are challenging may be an efficient way of helping people with less complex needs inadequate resources: equipment and internet connections of low quality processes and preferred platforms not clearly established staff may lack training and confidence impacts on communication and therapeutic relationships may be harder to establish and maintain a good therapeutic relationship may be harder to make an assessment, especially at first contact may be challenging for longer, more in-depth sessions digital exclusion: people who lack equipment and resources to connect people who don't have skills or confidence to connect (including people with cognitive impairments) people lacking a suitably private environment for remote appointments service user preferences: some service users strongly prefer confidential conversations to be faceto-face, or may feel suspicious or anxious about remote means if they do accept remote contacts, some prefer simpler phone or messaging modalities some service users do not engage with remote contacts than face-to-face consultations had resulted in not having contact with some service users who had not engaged with remote appointments. two-thirds ( . %) answered yes when asked whether they wished to retain longer term any changes made during the pandemic. table x summarises responses. a large majority involved keeping some aspects of remote working, with many feeling that selective use of technology platforms to connect staff with each other and with service users has potential long-term benefits for efficiency and the environment, particularly if technical difficulties are resolved and appropriate protocols developed. others wished to retain some new service initiatives, such as crisis centres in the community, or the increased flexibility and ease of making changes experienced at this time. responses to a question about concerns for the future were numerous and detailed (table x) . while many participants reported that referrals to their service had decreased in the early phase of the pandemic, many feared that need would increase significantly in future and that lack of capacity and staff burnout may impede response to this. anticipated drivers of increased future need included traumas, bereavement, and complex grief experienced by frontline staff, service users, and the wider public; mental health problems not managed effectively among people who have disengaged or not sought help during the pandemic; increased levels of domestic abuse and family conflict; and the effects of wider societal disruption and increased inequalities due, for example, to unemployment and homelessness. fears were also expressed that reduced levels of service might persist inappropriately after the current emergency period, that changes made in response to the crisis might be used to justify reduced funding in future, or that staff would be expected to continue with working patterns that they had agreed to only because of the crisis. extension of remote working beyond the circumstances in which it had proved helpful was a further concern. several respondents were concerned about the disproportionate impact of the pandemic on black, asian, and minority ethnic staff and service users, and about potentially increased racism and xenophobia. a wide range of challenges are reported by practitioners across the mental health sector, some specific to service settings or groups of service users and carers. while many commentators have predicted a significant and widespread impact of covid- , we are able to provide a more detailed report that is rooted in direct experience of the effects of the pandemic on mental health care, albeit only in one country and only from the perspective of practitioners. in the context of the pandemic, infection control is an immediate need whose complexity in mental health settings is a significant finding from our study. lack of ppe was sometimes identified as a problem. more prominent, however, were challenges relating to processes, to the physical environment in which mental health care is delivered, and to tensions between infection control requirements and providing safe care and maintaining therapeutic relationships with people who may be distressed, suspicious, or struggling to comprehend the situation. inpatient and residential services, and crisis services, where continuing face-to-face contacts appear more frequent than in routine care, are not surprisingly the settings in which staff are most immediately concerned with the spread of infection: the price of failure is potentially very high, as indicated by a recent care quality commission report on excess deaths related to covid- among people subject to the mental health act [ ] . the shift to remote working, strikingly rapid given that tele-health has been discussed over many years but with limited implementation, has been widely discussed; we examine staff perspectives on this in detail in the current study. both our quantitative and qualitative data suggest clear support for its partial adoption in the longer term: remote contacts are seen as valuable for staff meetings, and for convenient and environmentally friendly follow-up of well-engaged clients with access to and a positive view of technology. however, staff give a very clear warning that there are still important technological, social, and procedural barriers to be addressed, and that its use should remain selective, complementing rather than replacing face-to-face contact. this and other innovations that we document above suggest that, as in other domains of healthcare, there has been considerable agility and flexibility in at least some service contexts during the current crisis, with urgent needs overcoming well-documented barriers to implementing new ways of working. however, while responses to our question about innovations that staff would like to retain were numerous, serious concerns regarding both the short and long-term future were also widely expressed: these data were collected at a very early stage in the covid- pandemic. mental health services in the uk were already under pressure prior to the pandemic [ ] and swift attention, strategic planning, and resources will be required to meet widely anticipated additional demands from people affected directly or indirectly by the impact of the pandemic. this is only one perspective on the impact of the pandemic on mental health care, albeit one rooted in direct experience: it will be essential to investigate service user and carer perspectives, and to measure impacts on the mental health system more systematically as further data become available. given the unprecedented pace of change in the world and in mental health services, we prioritised gaining a broad overview of impacts and responses, but much detail will have been missed. our questionnaire was by necessity an ad hoc and not an established and validated tool. omissions were noted as the study progressed: it was assumed that impacts of the "lockdown" for service users were negative, but positive experiences are noted too, for example of reduced pressure or easier access for people who struggle to travel [ ] . more importantly, we designed the questionnaire early in the pandemic when the evidence of differential effects on some ethnic groups was less striking [ ] : closed questions do not focus on this, although these effects and issues of racism are included in open-ended responses on concerns for the future. our sample, gathered by disseminating our questionnaire through a range of channels, is not representative of those who work in mental health care settings, and may either over-represent people who have strong concerns about the situation or those who wish to report successful new practices. we managed to include a range of professions and work settings, but did not recruit as successfully as we had hoped outside the nhs-more targeted efforts and time are likely to be needed to reach relevant staff from other sectors. many people with mental health difficulties also come into contact with gps, pharmacists, paramedics, and a&e doctors and nurses, especially if they are not under secondary services; we have not included these perspectives. we are especially concerned that, while we do not have any definitive overall figure for the uk mental health care workforce, it is clear that the number of non-white participants in our survey is relatively small, despite targeted efforts to increase their number and a strong emphasis on anonymity and confidentiality, as advised in the previous discussions of this frequently experienced difficulty [ ] . further efforts to engage and form partnerships are likely to be needed here too. london also appears over-represented and rural areas, which may have distinctive challenges, under-represented, and we have not at this stage disaggregated data by country, region, or area type. we present here a series of snapshots capturing, from a staff perspective, the situation in mental health care services in the rapidly evolving early stages of the covid- pandemic. this work cannot yield definitive answers and should be interpreted alongside other perspectives, but offers researchers, service commissioners, managers, and policy makers directions for service development and further rapid research. regarding immediate priorities, our findings point to specific challenges to be addressed to achieve more successful infection control. remote working is a further immediate focus for research and service developments. participants' accounts suggest that it has been helpful in keeping services going and maintaining some level of contact in the community, and aids communication between staff. there is now a need to develop clearer processes in collaboration with service users for its targeted use, to implement guidance and evidence that already exists [ ] , and to explore ways of overcoming barriers to its effective use. mental health providers in the uk and elsewhere have demonstrated unprecedented capacity for rapid adaptation and innovation during the early pandemic period. recovery from the pandemic is a potential opportunity to establish new ways of working, for example with greater co-production with service users, and more widespread implementation of effective interventions and technologies [ ] . this will require sufficient resources, rapid production and translation of evidence, effective planning that engages all stakeholders, and great attention to workforce support and prevention of burnout. it is reassuring to see that staff share many of our concerns about the covid- pandemic: premature discharges, isolation, difficulties with infection control, and accessing care. many of these are reflected in the madcovid project's materials (https ://madco vid.com/). telemedicine drew mixed views from staff; we would like to highlight some difficulties. not everyone has a safe space to speak, may only have privacy in their bedroom or none at all. telemedicine works better for those in better, not-overcrowded housing, so risks widening inequalities in access to care. for many of us, our home is our safety, and it is important to have distressing conversations elsewhere. leaving the therapy room, we can leave some of our trauma behind. video calls may feel invasive-as though the clinician is in your bedroom-bringing up traumatic issues inside the home, where we cannot escape them. any continuation of remote working will need to consider the safety implications of this, assessing its suitability for each individual. it is vital that difficulty adhering to infection control guidance does not lead to blaming inpatients for viral spread. this is particularly important with restraint, where staff mentioned struggling to put on appropriate ppe in time to deal with an unfolding emergency. wide area variations in restraint rates (https ://www.mind.org.uk/media -a/ /physi cal_restr aint_final _web_versi on.pdf [ ] ; https ://weare agend a.org/ wp-conte nt/uploa ds/ / /restr aint-foi-resea rch-brief ing-final .pdf [ ] ), alongside personal experience, make us question whether restraint is ever truly unavoidable. if it places both staff and service users at risk of covid- infection, it is doubly dangerous. however challenging the situation, efforts must be renewed to reduce the iatrogenic distress, fear, and anger which can lead to its use. historically slow-moving services have implemented change at breakneck speeds in response to this crisis despite significant difficulties. service users have campaigned for changes for decades. it is time to implement these changes with the same urgency. the survey dataset is currently being used for additional research by the author research group and is, therefore, not currently available in a data repository. a copy of the survey is available at this web address: https ://opini o.ucl.ac.uk/s?s= . conflicts of interest sj, as, ble, so, and sc are grant holders for the nihr mental health policy research unit. ethics approval the king's college london research ethics committee approved this study (mra- / - ). consent to participate information on participation was provided on the front page of the survey. by starting the survey, participants agreed that they had read and understood all this information. it was explained on the front page of the survey that responses may be used in articles published in scientific journals and that these articles will not include any information which could be used to identify any participant. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creat iveco mmons .org/licen ses/by/ . /. psychiatrists see alarming rise in patients needing urgent and emergency care and forecast a 'tsunami' of mental illness the lancet psychiatry. mental health and covid- : change the conversation ( ) mental health in the age of coronavirus: time for change. social psychiatry and psychiatric epidemiology the covid- global pandemic: implications for people with schizophrenia and related disorders quality of life, autonomy, satisfaction, and costs associated with mental health supported accommodation services in england; a national survey expert reaction to new advice to support mental health during the covid- outbreak physical health pandemic vs mental health 'epidemic': has our mental health been forgotten? mental health today mental health services in lombardy during covid- outbreak patients with mental health disorders in the covid- epidemic the covid- outbreak and psychiatric hospitals in china: managing challenges through mental health service reform remote consultations in the era of covid- pandemic: preliminary experience in a regional australian public acute mental health care setting innovation during covid- : improving addiction treatment access covid- mental health policy research unit group ( ) first reports regarding impacts of the covid- pandemic on mental health care and on people with mental health conditions: an international document analysis using mixed-methods sequential explanatory design: from theory to practice using the framework method for the analysis of qualitative data in multi-disciplinary health research three approaches to qualitative content analysis our concerns about mental health, learning disability and autism services funding and staffing of nhs mental health providers: still waiting for parity. the king's fund disparities in the risk and outcomes of covid- increasing response rates amongst black and minority ethnic and seldom heard groups video consultations: a guide for practice how mental health care should change as a consequence of the covid- pandemic physical restraint in crisis: a report on physical restraint in hospital settings in england briefing on the use of restraint against women and girls key: cord- -tnsubtjr authors: baztan, juan; vanderlinden, jean-paul; jaffrès, lionel; jorgensen, bethany; zhu, zhiwei title: facing climate injustices: community trust-building for climate services through arts and sciences narrative co-production date: - - journal: clim risk manag doi: . /j.crm. . sha: doc_id: cord_uid: tnsubtjr the goal of this paper is to analyze how and with what results place-based climate service co-production may be enacted within a community for whom climate change is not a locally salient concern. aiming to initiate a climate-centered dialogue, a hybrid team of scientists and artists collected local narratives within the kerourien neighbourhood, in the city of brest in brittany, france. kerourien is a place known for its stigmatizing crime, poverty, marginalization and state of disrepair. social work is higher on the agenda than climate action. the team thus acknowledged that local narratives might not make much mention of climate change, and recognized part of the work might be to shift awareness to the actual or potential, current or future, connections between everyday non-climate concerns and climate issues. such a shift called for a practical intervention, centered on local culture. the narrative collection process was dovetailed with preparing the neighbourhood’s th anniversary celebration and establishing a series of art performances to celebrate the neighbourhood and its residents. non-climate and quasi-climate stories were collected, documented, and turned into art forms. the elements of climate service co-production in this process are twofold. first, they point to the ways in which non-climate change related local concerns may be mapped out in relation to climate change adaptation, showing how non-climate change concerns call for climate information. secondly, they show how the co-production of climate services may go beyond the provision of climate information by generating procedural benefits such as local empowerment – thus generating capacities that may be mobilized to face climate change. we conclude by stressing that “place-based climate service co-production for action” may require questioning the nature of the “services” rendered, questioning the nature of “place,” and questioning what “action” entails. we offer leads for addressing these questions in ways that help realise empowerment and greater social justice. today, there is some irony for us to work on a paper tackling issues of priorities, justice, and the interconnectedness of climate issues with most issues of social justice. as we are writing these words, we are locked-down, contributing, through isolation, to a fight against a very disruptive world scale pandemic. we have somehow imperfectly shifted our priorities. many of us observe that covid- has shifted all sorts of priorities. some of us long for a world a world where priorities will be, at long last, straightened-out -thanks to the lockdown and the realization that some things can grind to a halt if really needed (latour ) . some see current events not so much as a crisis, but as a necessary, and painful, wake-up call leading to an evolution in our ways of inhabiting the world. if there is lesson to be learned from covid- , it is that priorities are contextual and short-term crises, mutations, may blind us from more pressing challenges (the intertwining of climate change and pandemics takes many twists and turns, see for instance ord ) . we have known for a long time that pandemics and climate change may be connected, and climate justice may very well be one of these connections. this paper contributes to the growing body of the literature on climate service co-production; coproduction understood here as a normative practice that consists in "the deliberate collaboration of different people to achieve a common goal" (bremer and meisch , pg. ) . we chose to analyze a climate service co-production situation where potential climate information users were not necessarily aware of the importance of climate change in their daily lives. we developed an intervention allowing for the analysis of how and with what results place-based climate service coproduction may be enacted within a community whose locally salient concerns do not include climate change. while envisioning local climate change adaptation action, one may have to face the fact that for some communities climate change might not be high on the local agenda. the issue is not necessarily that such communities negate the salience of climate change and its impacts. some communities may have other challenges that are more pressing and not obviously climate related: marginalization, poverty, resource depletion, crime, sense of powerlessness, health, housing, education, cultural erosion. some communities are facing short-term challenges for which all their energy is mustered -other stressors do matter (e.g., ahmed et al. , mccubbin et al. ). yet these communities are and will be facing climate change and its impacts. it is quite likely they are already in a position where climate change adaptation may be necessary. they may thus need climate science attuned to their specific challenges, however they are not yet part of the visible "demand side" for climate services such as climate information. climate science will have to deploy itself in accordance with their priorities, which are not climatecentered. these situations raise questions about the legitimacy of climate action in the face of social and economic hardship not directly connected to climate challenges. who has a say in priority setting? can an issue seen as salient from outside a community be somehow made salient for those within the community? by whom, and under what conditions, is exogenous priority-setting acceptable? concern about exogenous priority setting and its associated marginalization led our team of scientists and artists to engage in fieldwork in the kerourien neighborhood, the results of which we present in this paper. we share a story of seemingly competing priorities, external and internal. through climate service co-production, which we see as an avatar of transdisciplinary research, we conducted a real-life experiment where scientists and artists focused on developing approaches for place-based climate service co-production by reaching out to a community that has other, more pressing concerns than climate change. the kerourien neighborhood, in the city of brest located on the coast of the brittany region of france, is better known for its stigmas (e.g., high unemployment rate, state of disrepair, drug-related violence) than for its awareness of climate issues. yet climate change is the symptom of broader issues, and is intimately connected to social issues (see krauss ) and it seemed to the research team that kerourien's challenges deserved to be explored through the lens of climate change. we first present a summary of the literature we drew from to design our on-site intervention, including: climate change adaptation and local contexts, art and science approaches to climate intervention, and climate service co-production as an empowering transdisciplinary practice. we then describe the cocliserv project and the kerourien community. the results section focuses on the process in which we participated, its outputs in terms of approach, procedural and substantive benefits, and entry point for place-based climate information design. we focus on locating climate change within apparently non-climate related narratives and on the ubiquity, yet invisibility, of climate change within kerourien. we further discuss the procedural and substantive benefits of the work conducted. local context, climate services, and art and science co-production "climate science usability is a function both of the context of potential use and of the process of scientific knowledge production itself" (dilling and lemos ) . it is now widely documented that climate change adaptation is dependent upon local contexts and there are no one-size-fits-all solutions (ipcc ). culture (adger et al. ) , local knowledge (naess ) , local institutions (berman et al. ) , the intertwining of local and global political forces and history (kennedy et al. ) , are examples of dimensions that define the ability of a community to face climate change. the provision of meaningful and usable climate information at the local level, therefore, entails some sort of tailoring. there are now case studies illustrating the mismatch between climate science and local interests (e.g., baztan et al. ) providing information does not necessarily mean local users will be able to make use of it. climate science may need to be linked more directly to local communities, to their particular capacities and contexts of vulnerability (ipcc , vaughan et al. . as bremer et al. ( ) put it, "scholars and practitioners have been ill-equipped to describe the contexts where climate services are introduced, or interpret how context can shape the way they develop" (pg. ). co-production has been proposed as one approach for addressing the challenge of turning climate science into a usable climate service. not only does knowledge co-production allow for better usability and implementation, it has many increasingly documented benefits such as social learning, empowerment, and inter-and intra-community trust building. for the purpose of this research we used, as starting point, vaughan and dessai's ( ) definition of climate services: "the aim of climate services is to provide people and organizations with timely, tailored climate-related knowledge and information that they can use to reduce climate-related losses and enhance benefits, including the protection of lives, livelihoods, and property" (pg. ). when considering this definition, we focused on providing people with climate tailored knowledge, "people" understood as members of local communities. the central challenge we wished to address was that of "tailoring" climate knowledge and information for communities at the margins, who might not be very aware of climate issues. such tailoring of climate knowledge is closely associated with the ability to establish iteration (dilling and lemos ) and dialogue (vaughan and dessai ) between scientists and non-scientists in the course of knowledge production and use. climate knowledge co-production, the "deliberate collaboration of different people to achieve a common goal" (bremer and meisch , pg. ) has been proposed for quite some time (e.g., lemos and morehouse ) to address challenges of initiating and maintaining such reiterations and dialogues. but what if this dialogue needs to be established on grounds other than those of climate change? bremer and meisch ( ) conducted an extensive mapping of the literature on climate change research co-production. they identify a series of eight "conceptual lenses" and call for a "selfreflexive transparency when using co-production concepts" (pg. ) to address the concepts' polysemy. within their framework, the work we conducted lies at the juncture of several objectives associated with these lenses: we want to integrate non-scientists as co-investigators (extended lens); we wish to sustain interactions between climate science providers and users (iterative interaction lens); we pursue a goal of empowering local experience, and thus of local knowledge (empowerment lens); we recognize the need to facilitate social learning about climate issues (social learning lens); and we are embedded in a culturally-rooted goal to improve public service through the joint engagement of government agencies and citizens in the production of new knowledge (public services lens). all these objectives are associated with acknowledging the current uneven distribution of access to, and benefits from, climate services development (vaughan and dessai ) . for instance, harjanne ( ) surveyed institutions related to climate services to identify how they justify the need for climate services (as a departure from climate science), and identified the following rationales: the global and widespread nature of the climate challenge; specific industry needs; socio-economic value; technological potential; and deficient supply and demand. there seems to be very little room left for marginalized communities. in the work presented here, we envision the co-production of climate services, not because we perceive co-production as a "value in itself" (voorberg et al. ) , but because we see co-production as a means to create and nurture sustained interaction with marginalized communities while contributing to their empowerment. we wish to explore means for correcting the inequitable distribution of climate change knowledge for action. this uneven distribution in part reflects the fact that not all communities are equal and some are facing such immediate challenges that climate change may be invisible to them. over the course of the research presented here, this called for working to shift awareness to the actual or potential, current or future, connections between everyday non-climate concerns and climate issues. such a shift required a practical intervention centered on local culture. we chose to work hand-in-hand with artists to conduct such an intervention, as art is well-identified as an approach to make visible the "invisible or almost-visible" phenomenon of climate change (knebusch ) . art is also identified as facilitating access to narratives in general, and climate narratives in particular (roosen et al. ). art-based intervention has been proposed in the context of climate change for quite some time (lippard , volpe ). this is not without pitfalls such as instrumentalising art, and reproducing dominant categories and codes through art (miles ) . experiments have shown that through public participation and activism, art may be empowering, and may shift attention to issues that question dominant paradigms (sommer and klockner ) . several dimensions have been identified for collaborations between art and science: new understandings and capacities within and across the arts and sciences involved (gabrys and yussof ) ; catalysing explorations of the scientific context and critical re-imaginings of research practices (rödder ) ; helping to engage multiple senses and emphasizing social interaction within research practices; aiding participating researchers in thinking creatively (jacobson et al. ) ; redesigning social relations to natural systems (armstrong and leimbach ); rearticulating politics and knowledge (latour ) ; offering more effective approaches to engaging multiple publics in climate-compatible behaviour change; and engaging explicitly with the underresearched issue of the role of place attachment and local, situated knowledge in mediating the influence of climate change communication (burke et al. ) . capitalizing on these observations, we developed the working hypothesis that iterative art and science approaches have the potential for instigating and sustaining community dialogue through efforts to co-produce climate services. we saw art as essential for making the concept of climate services more meaningful in a specific place, and focused on narratives as an entry point for coconstruction. artists are ideally placed to challenge existing narratives and to provoke the exploration of new narratives. the intermeshing of nature, culture, emotions and reason around weatherscapes implies that approaching local climate through science could be put into perspective by a more intuitive approach seeking to represent the world as perceived by the senses. such an approach has been achieved by including the arts in social dynamics together with scientific research and innovation (bilodeau, ) . we envision the integration of art and science not in terms of using the arts to communicate scientific findings, but rather in terms of gaining access to elements that are generally excluded from scientific inquiry to convey a more complete picture of the challenges at hand. developing a strong connection between art and science enables the rearticulation of the scientific description of the world (latour, ) . we proposed to test if an art and science based 'recomposing' of the world (latour, ) allows for locally clarifying ambiguous concepts such as climate change and associated "services". our investigation entailed examining the potential of art 'gestures' (citton, ) and the 'practices of everyday life' (de certeau, ) to facilitate cultural translation between different fields of knowledge and the associated diversity of priorities. the results presented here are from a broader project entitled "co-development of place-based climate services for action" (cocliserv, http://cocliserv.cearc.fr), implemented in parallel at five sites: jade bay in germany (krauss ) , bergen in norway (bremer et al. currently under review) , dordrecht in the netherlands (marschütz et al. ) , the gulf of morbihan (da cunha et al. under review), and the kerourien neighborhood in brest, france. these sites follow a shared methodological design starting with narratives as an entry point (krauss ) and extending to incremental normative scenario design (vanderlinden ) . these steps are transversely associated with: (a) identifying available climate information and potential gaps to be addressed now or in the future, (b) developing a suite of representational tools and participatory approaches (e.g., outreach material, art and science procedures, participatory metadata scheme developments and mapping, citizen science), and (c) creating a knowledge quality assessment protocol tailored to the needs of the project. the narrative dimension of the project is seen simultaneously as a "first step" and a step that yields results in and of itself. more details on the cocliserv narratives can be found in the "narratives of change" work, led by werner krauss (krauss , krauss and . one of the central challenges in designing the cocliserv project related to generating a sufficiently broad and diverse set of ground-truthing sites to assess how the approach would fare in different settings as it was being developed and tested. within the participating communities, the kerourien site -the focus of the experiment we present here-was unique. in kerourien, climate change is not a visible concern; residents of kerourien face other daily struggles that take priority and the research team had to adapt to their situation. the peri-urban neighborhood of kerourien is in the port city of brest (brittany, france). it is located in a coastal area with low population density on the western edge of france. kerourien is a minute walk from where the bay of brest connects to the mer d'iroise, part of the atlantic ocean system. it is technically coastal, however its residents are not seafarers or fishers, they live in a suburban housing development similar to many found throughout france. climate change and its effects have been studied in the brest area for decades. we know today, as shown for example in l'hévéder et al. ( ), that temperature plays a fundamental role in ocean circulation; stratification; chemical and biogeochemical processes such as degradation, dissolution, precipitation; and in controlling the spatial distribution, metabolic rates and life cycles of marine flora and fauna (e.g., bissinger et al. , chen , helmuth et al. , philippart et al , thomas et al. in l'hévéder et al. ). kerourien's context is that of an oceanic region with sea temperature sensitives to global change, this area is a biogeographic boundary zone and in recent years warm water species have become much more common (southward et al. ) . ecological problems related to sea surface temperature change also include alterations in nutrient delivery from land to sea; arrival of invasive species and changes in host-pathogen relationships and biological interactions (poloczanska et al. ). these observations are combined with coastal erosion and extreme weather events such as droughts, exceptional storms, and heat waves, as experienced in . the - city climate plan for brest pays particularly close attention to mitigation, and thus to energy production and consumption, concluding that: (i) housing (heating, hot water, and all uses of electricity) is responsible for % of energy consumption in the brest metropolitan area and % of greenhouse gas emissions. the energy used in the brest metropolitan area is mainly of fossil origin (gas: % and oil: %), the net quantity stored annually in the brest metropolitan area is estimated to be , tonnes of co , i.e., around % of its annual emissions. while adaptation planning is a legal requirement, mitigation seems to remain higher on the city's list of priorities. kerourien has residents ( census), and the neighbourhood is mostly organized around post-war housing projects. it is a priority area for the city, which implies a well-identified social vulnerability including demographics such as: . % single-parent families, with % of its residents under the age of , and more than nationalities represented. kerourien is one of the most diverse areas in the city and faces the most challenges in terms of urbanization, migration, and disempowerment (fig ) . thirty-two percent of its inhabitants are unemployed versus % in the rest of the city, with an apex of % for youth between the ages of - versus % for the rest of the city. the schooling rate for youth ages - is % versus % for the rest of the city. this is kerourien's current context. from the neighbourhood's beginning there have been efforts for improvement conditioned by its unbalanced social structure. currently five formal social work organizations conduct on-going efforts here, but with high unemployment and growing imbalances, the question often arises: "who helps whom"? key observations . on the process of linking a local event and our climate services centered inquiry the initial step of our co-production work focused on collecting narratives. this was an ad hoc process, which evolved along the way. we present our approach and associated observations as the first part of our results, describing the organisational stages and observations of procedures and materials ( table ) . as a starting point, we formed a working group with four partners who had participated in preparing the project, including: the maquis, the centre social couleurs quartier, the theatre du grain, and the cearc research center. the five initial meetings focused on identifying the means to simultaneously mobilize the neighbourhood around locally salient issues while giving access to potential conversations about climate-related concerns. the upcoming th anniversary of the neighbourhood was chosen as an opportunity to achieve this goal. a list of stakeholders was established by the four core partners with the provision that snowballing was possible if a category had been overlooked. accordingly, over the course of events we incorporated additional partners, but to a limited extent and very progressively. the initial stakeholder list comprised eight groups and institutions. after limited snowballing, it expanded to members (table ) these stakeholders were invited to a foundational meeting to identify shared objectives within the context of organizing kerourien's th anniversary celebration. the goal that generated the most widespread support was to dispell the myth that "in kerouien only bad things happen". the anniversary celebration was thus named les belles histoires de kerourien (kerourien's beautiful stories). the group of stakeholders formally became the local coordination committee for the th anniversary. at that point, the aim of climate service co-production seemed remote. however the intention, climate-services wise, was to gather narratives in order to explore the linkages between explicit concerns and climate issues, which seemed mostly invisible in kerourien. working on les belles histoires with and for kerourien residents seemed to be a challenging and promising opportunity. we held monthly meetings of the -member local coordinating committee. these occurred under the leadership of its rapidly established executive board, composed of four members of the initial core working group. in the course of these meetings, stories were progressively identified. four important developments were observed: . members of the group acknowledged the need to increase the involvement of community members; . systematic archive research became necessary because, according to those around the table, the stories being told needed anchoring in dated, identifiable events that those present had not necessarily witnessed but that were still part of the memories of the neighbourhood; . an interview protocol was devised to simultaneously involve more members of the local community and gather stories in the words of those most affected; . practical matters were delegated to implementation committees tasked with managing specific practical concerns for the th anniversary celebration, such as: welcoming/ticketing; hiking, cycling, scooters; canteen/kitchen organizing; reports, video editing, projections ( in total). these were powerful recruitment tools, and many community members participated. these developments were important on two levels. first, the local coordinating committee turned to the a priori climate-centred transdisciplinary team to mobilise their expertise in terms of public participation and research. second, it allowed for a more systemised approach to recruitment and collecting local and non-local narratives. a transdisciplinary research design was then adopted to prepare the th anniversary celebration and its associated art form. this included systematising the identification of archive materials, their sorting, key-wording, storage, and subsequent use. these archives contained materials such as: personal photographs, drawings, memorabilia, media excerpts, and recorded songs collected through on-site participant observation. gathering the archive had two effects. first, it allowed us to put kerourien's stigma in perspective both as the product of historical and political processes, and as the product of the amplification of anecdotal events. second, compiling the archive also lent a sense of materiality to the process. a semi-structured interview protocol was designed and the associated interview framework was developed. both were developed with input from the local coordination committee and members of the local community. the interview protocol contained the following questions:  where were you born?  what was the path you took that brought you to kerourien?  can you tell us about the first time you came to kerourien? how did you feel?  tell us about three events in kerourien that have been important to you (personally).  how do you feel when you look at kerourien today?  can you describe three dreams you have for kerourien in (in years)?  what would it take to make them come true?  do you have anything you would like to add? the interview process led to the collection of narratives that stressed the need for les belles histoires. interviewees were proud to be part of the neighbourhood and expressed a deep wish to shift the stigma and be seen by the city as the decent people they recognise themselves to be: "what i like is the moments when you help people and they thank you. help with a stroller, or the shopping bags of an elderly lady, hold a door. small moments like that and people thank you. a thank you. not much, but attention, a gesture, a coffee, a smile." "we have lots of things to do. and in kerourien we think, we act, we do a lot of things for people to gather. faced with the disorder of the world, here kerourien is bubbling with ideas. how, in the face of global reality, we invent something here to rebuild, to find meaning, with the people of the neighbourhood. many people do not give up. continue tirelessly to fight, to resist. day by day. right here. now." at that point, our experiment in climate service co-production had taken quite a turn. first, narratives were being collected with a level of robustness that would make them usable in a science-centred process. second, the team of climate social-scientists and artists were putting their skills to work to serve the local community in realms that may seem far removed from climate issues, but that allowed for a fascinating exercise in trust building and, as a result, quite extensive data collection. papers, objects, newspaper clippings, bits and pieces of local narratives, were made physically available. this led to another important development: obtaining two rooms and bathrooms fully dedicated to those preparing the th anniversary celebration. this locally anchored what had otherwise been a "placeless" exercise. stories, archives, drawings, timelines all could be pinned on the walls. interviews were conducted in the les belles histoires room. involvement continued growing, with community members "just passing through" to "take a look," and thereafter staying around, becoming contributors to the anniversary celebration preparations and the archive and narratives corpus we were compiling (table ) . for the climate service co-production work, it meant a wealth of stories were made available. ongoing dialogue with and participation from the artists meant that a central art form was taking shape. this acted as a filter, prioritizing local issues as they appeared in the stories being told. a script and a scenography emerged, encapsulating the stories being told in kerourien. table : summary description of the data collected through the joint process of preparing kerourien's th anniversary and collecting narratives as part of the climate service co-production process. this process (table ) led to material and procedural benefits. on the material front, robust data were collected. these were used for creating an art form and for laying the foundations for the climate service co-production process. on the procedural front, the neighbourhood was highly involved and, more importantly, trust had been built and mobilised for collective action. start of the project's implementation in kerourien / setting up the working group / these four partners have a well-established working relationship: trust between them is well established. issues of symbolic hierarchies, associated with status (artists are not as regularly employed as social workers or scientists) initial meetings and identification of a modus operandi / decision taken to contribute proactively the neighbourhood's th anniversary celebration. the anniversary was to take place in june , then delayed to october . content and program are still a total blank slate. identification and invitation of all potential stakeholders / foundational meeting of the local coordination group. the initial working group is turned into the local coordination group executive board / proactively implementing the local / / meeting facilitation was organized around the following aim: identifying a common goal for all present, around which everyone could be mobilized. of the members, are residents of the neighbourhood and act as initial proxies for the coordination groups' decisions. resident population. monthly meetings of the local coordination group / discussing the planning and programming of the th anniversary. from / to / all decisions taken collectively. when the group deemed it necessary, votes were organized. this was the first step to spread the word and be publicly explicit with the intentions and partnerships. tasking a specific group with conducting interviews. / - / obtaining fully dedicated facilities ( rooms and bathrooms). agreement with the city as landlord. moving the date of the anniversary from june to october. the decision was taken to document the process more systematically. establishing thematic working groups / specialized working groups are created. these working groups are open to anyone willing to contribute to organizing the th anniversary. the public presentation of the "beautiful stories" process. / / at h, h and h to be sure all residents have the chance to come if they wish. formal closure of the social centre after arson. / to / / the perpetrators are identified but the ongoing efforts of trust-building are damaged as well as the front door of the social centre itself. weekly meetings / discussing the process and detailed programming of the th anniversary. from / for some of the working groups. some meetings are working-group focused, some are plenary with all partners. poster proposed by the graphic artist, discussed at the coordination level and the final version made available to spread the word. a new iconic image for the neighbourhood. final programme available. efforts increase progressively going from weekly to daily. - / the number of people engaged grows day by day, the thematic working groups structure is key. kerourien's beautiful stories. a popular success with a strong public and mass media impact. "beautiful stories" review meeting. / people express that kerourien is whole again, community members have a renewed sense of sharing common narratives. what did the climate service co-production component of the process learn from the exercise up to now? first, we witnessed progressive involvement from community members. by embedding ourselves in a process focused on highly salient non-climate related issues we gained access to community members and to issues that would not have been accessible otherwise, including a diversity of narratives. more importantly, and this came a bit as a surprise, the transdisciplinary abilities of the research team were called upon to help achieve non-science centered goals. an initially asymmetrical situation became a situation of more balanced cross-fertilization. somehow our respective specialized lines of action became blurred and from this trust and capacity for action grew. this situation created a central question: how do we manage the different natures of the various processes at hand -celebrating kerourien, preparing an art form, and identifying how local issues relate to climate issues within the context of climate service co-production? as stated above in section . , our working hypothesis was that all issues are connected with climate issues, and these connections deserve to be made explicit. this hypothesis led us to commit to maintaining the blurring of the lines as artists working with and for social scientists when it came to the climate dimension; and social scientists working with and for artists when it came to preparing the art form, rooting it in local issues and giving the identified and collected stories back to the community. the process described here between artists, social scientists, and community members led to the joint identification of a series of three narratives seen as fundamental for the local community. these are available in detail, including interview quotes and the final script of the play, in the supplementary materials. we summarize these materials here, highlighting the most important characteristics. the narrative identification and explication process was conducted through a systematic analysis (iterative thematic analysis), conducted by the social scientists. the creative writing and scenography was conducted by the artists. these phases included on-going interaction with community members, and thus evolved under their constant scrutiny, including during the first ( figure ) and following days of the play. here we present the narratives in the order of their "discovery". a first narrative that stood out was that of the kerourien neighbourhood, its origin, and the trajectory of its first residents. schematically this narrative reads like this: when this narrative was identified, the experiment in climate service co-production could have taken a wrong turn. we could have had the illusion that access to the "place" had been gained. however the place, as a stabilized geographical and administrative space, located in brest, france, turned out to be a misconception. kerourien is made of many places, associated with the diversity of it inhabitants. does that mean this story should have been dispelled as useless? certainly not, it gives a wealth of information. for example, there once was agriculture, and the weather matters when discussing construction work. yet this is not kerourien's only story. other stories matter, and we did gain access to those as well. the second important story of kerourien reads as follows (see supplementary materials for details and interview excerpts): . we, the newcomers, settled in kerourien after leaving home (from abroad) in order to find a better life (and yes we did find it, at first). . since the s kerourien's population has been in flux (and individuals carry their sometimes heavy personal histories, and their traditions, seen as source of positive diversity). . integration within a diverse mix is proactively pursued (not always easily, xenophobia exists, as well as clear challenges associated with highly intercultural settings). promises that were made, mostly of vertical social mobility, are unkept). . there is nostalgia for elsewhere and anger toward "here." (kerourien encapsulates the love-hate relationship that any migrant community may have with its new country). box : "the first generation laid low. the second generation crashed. the third is restless." -kerourien's recent-present narrated as a multicultural entity. once this narrative was identified and clarified, we stumbled on something fundamental in terms of climate services development. kerourien is, for its population, just one of the places that matters. when envisioning brest's humid climate, it is compared with a place of birth, which is, for many, the place where they long to return upon retirement. if we are about to co-produce place-based climate services, we must prepare ourselves to expand our geographical horizons beyond brittany. further conversations indicated that these narratives of kerourien's history and the histories of its "newcomers" were connected though other avenues beyond simply being from kerourien. both "newcomers" and those "from the barracks" share life trajectories of adversity, proactive fights against dominant forces, and the need to contribute to a sense of justice. these characteristics are connected to the third dominant narrative we identified. . the harshness of the life in brittany, the war, and post-war reconstruction, created in brest strong unions, a strong civil society, ready to fight for its rights (even more so in low income neighbourhoods such as the barracks first, and kerourien thereafter). . the fight for social justice led, in the s and early- s, to genuine progress that reinforced kerourien residents' conviction in favor of social justice and the need to fight. neighborhood now, during the presidential election when the far-right candidate made it to the second round (people registered en masse as voters in order to have their voices heard). . today in kerourien community members continue walking the same streets while their context becomes increasingly fragile, they still want to take charge, but feel increasingly unable to shape their world. box : "i have a say" -kerourien narrated as a place fighting for justice. at this stage, the experiment in climate service co-production had access to a unique and locally validated dataset of narratives. these encapsulated local priorities, concerns, and, to a much smaller extent, their interaction with weather and climate. the narratives we collected show that kerourien residents are, indeed, stressed by their daily economic constraints along with societal challenges related to gender, racism and well-being. they do not seem to show much interest in kerourien's weather and climate. furthermore, when envisioning a relationship to the nexus of place, weather, and climate, the narratives seem to indicate that for the so called "newcomers", weather and climate has mostly been experienced in places other than kerourien. newcomers may have experienced weather and climate, but in diverse ways, associated with their diverse origins. moving from the comores, entails seafaring, flying, and having lived in intense relationship with the indian ocean, its power and associated weather patterns. this experience is not easy to relate to the experience of those migrating from mali who have experienced rainfall deficits at the margin of the sahara desert. the relatively mild and humid climate of kerourien may be seen as a relief for some, and as nuisance for others. the limited time some have spent in kerourien may simply not allow for much of a relationship with the local weather to exist. in order to further our inquiry, we tried to identify traces, even faint ones, of weather or climate information. this led us to reorganize the corpus (table ) in terms of weather and climate issues. three ways of grouping the associated narrations emerged from this reanalysis: climate/weather information sources; manifestation of climate or weather in one of the dominant narratives; and reference made to places where climate issues may be radically different than in kerourien and that are seen as central to the life experiences of the narrators. residents of the kerourien neighbourhood have access to mass media and their coverage of weather (mostly through weather forecasts, or coverage of extreme events, mainly storms) and climate issues. they also have access to information sources produced by authorities (such as information booklets about brest 's climate action plan) or by social action ngos (such as information booklets developed by an ngo centred on fighting for housing rights and covering the paris conference of parties in ). they thus have access to the dominant techno-scientific discourse on climate change. very little is available on their everyday concerns, on the places they hold dear, be it kerourien or their hometown in syria, mali, morocco or haiti. very little is even said about climate change impacts on water quality in the bay of brest. one striking finding from our analysis of the collected narratives is the inability of dominant climate change discourse to significantly influence local narratives. not that weather and climate are absent, they simply take another form. we identified several traces of weather and/or climate in the narratives we collected. first, living conditions in brest are very connected to the omnipresence of rain, drizzle, and water in a way that resonates with the situation in bergen (bremer et al. under review) . there is "mud" in the barracks, construction sites are dangerous because of "mudslides" and "slippery conditions." rain is associated with gray skies. coming from warmer climes: "it's not the cold that bothers me the most. it's the gray. i don't like fall. it's too wet, too gray". nowadays the weather in kerourien, for its residents, is relative to elsewhere, places that, thanks to the filters of nostalgia, are characterized by milder conditions, blue skies, easy living. the traces of weather and climate we found are not often from "over here". for many now, kerourien is not necessarily associated with their future. in the future, climate and weather encounters will occur elsewhere. the framing of the weather in kerourien per se follows the enthusiasm-to-regret cycle of the "the first generation laid low. the second generation crashed. the third is restless" narrative : "when i arrived there was snow. i was coming out of the oven. from a hot climate up to °c in february. and i was going into the refrigerator. from hot there to cold here. i was happy to see the kids playing with the snow." the climate of the emotions guides the judgement of the external climate, that of rain, cold and grey skies, shaping a "sense of climate." when the future is envisioned in kerourien, we interpret it through a climate lens as a future that will be the product of the fight between forces of progress and reactionary forces, with kerourien on the side of progress: we observed that, while rarely present in explicit terms, weather and climate are part of the background of kerourien's narratives. from here, we turned to connecting to climate change issues through these stories. these stories, their material, ethical, and emotional dimensions have been recognized as important by community members. for the climate service co-production team, they constituted an escape route away from the dominant technocratic climate change discourse that is currently a non-starter for kerourien residents. by engaging in the process of jointly creating an art form and gathering data while preparing an event with local significance, we managed develop trust and establish mutually beneficial relationships between kerourien community members and the transdisciplinary research team, even leading to the co-production of climate services. vincent et al. ( ) stress that climate services are more than information alone. they are about producing long-term relationships and trust. in kerourien the situation was slightly different, as we were not in a position to engage in a relationship by talking about climate change (see krauss for another instance of such a situation). our challenge stopped at simply engaging in a relationship, let alone one built on climate concerns. we were in a situation where we wanted to "prime the pump" of a co-production process. trust-building in our case study was a condition for co-producing climate services, and a product of our process. this intervention primed not only the co-production of climate services, but also a desirable positive feedback loop. another important observation relates to mutual learning, in the sense of learning to do things together (see perron , vincent et al. ) . one key element that stood out in this experiment was the way in which the transdisciplinary and scientific skills of the research team were put to work for non-scientific purposes, namely the preparation of a neighbourhood's anniversary celebration. learning and trust-building were deeply intertwined for this. as our case shows, those on the science-side of co-producing climate services may render other services to the communities with whom they engage. through this observation we see that co-producing climate services may actually be more about transdisciplinary science than about climate science. this suggests climate service co-production is following the example of sustainability science (see mauser et al. , polk but with a narrower, and much more local focus. finally, we collectively identified a limited set of narratives encapsulating what kerourien residents had to say about themselves. in the words of some of the participants, this process, and the associated les belles histoires, did put the kerourien community back on track to becoming whole again. these stories constitute what the residents all share, at least for the time being. having this renewed common ground is making them stronger than before our co-production intervention. a stronger community will be able fare better in the face of climate change. for our purpose of coproducing climate services, a stronger community will be a stronger partner, more reliable, and more aware of its actual needs. not only did we develop trust with the kerourien community, we all became stronger in the process, stronger for engaging in substantive work, stronger for taking stock of the substantive effects of our intervention. climate services are often assessed against their usability. our research demonstrates this is not sufficient; the procedural benefits of co-producing climate services should be assessed as well. context dependency will make such evaluation particularly challenging. this should not prevent climate service funders from taking stock of the wider social benefits the actions they support bring to co-producing partners. . getting the priorities straight: adopting local values and contributing to justice. the initial step of our co-production process allowed us to anchor our actions in local stories and relate directly to our partner community and its values. this allowed us to free the co-production team from dominant (and technocratic) climate change and adaptation discourses. rather than adopting the pervading culture represented in the climate literature available to the community, we adopted narratives associated with everyday life, hardships, the joys and pain of migration, and engagement for greater justice. through the lens of priority setting, climate service co-production has much to learn from participatory research and participatory planning. for instance, one aspect we did not address explicitly in this experiment in co-production was that of gender. in the realm of participatory research there many analyses showing that one should be explicit about gender and other identity dynamics at play -the "whos voices? whose choices?" questions that need to be answered (cornwall ) . in the case of climate service co-production, the dominant discourse may totally blind co-producers with its technocratic, mainstream scientific stance; it seems too often to consider gender, race, class, and other social categories, as not necessarily part of what deserves attention. within the realm of climate change, our results point to "the importance of (re)politicizing coproduction by allowing for pluralism and for the contestation of knowledge" (turnhout et al , pg. ). as krauss ( ) writes, "a focus on narratives shifts the attention from the impact of climate on society to the myriad of entanglements between human and non-human actors in a changing climate" (pg. ). this shift in focus will allow us to ground further steps of climate service co-production in the priorities of those most vulnerable to the vagaries of the world. . extending the geographical boundaries of empowerment and the fight for justice: revisiting the concept of place finally, paying attention to local stories and the role of weather and climate within these stories led us to the realization that locally place-based climate service co-production may actually entail working with multiple locations and associated issues. co-production challenged our routines (krauss ) . it pushed us to reconceptualize "place" as extending beyond the circumscribed location where our co-production partners were living at the time. this opened up a rich perspective in terms of climate service co-production. in the course of our work, place became a relational concept, the definition of which belonged to the members of the co-producing community -what mattered what their sense of place (see stedman ) . sense of place is an integrative concept (saarinen et al. ) , and it carries both the characteristics of the environment and of the individual or group perceiving it. sense of place connects with place attachment, and others have shown, as we observed, how memory is critical for migrant populations' relationships to places (rishbeth and powell ) . by adopting this extended concept of place, the co-production team had to accept that knowledge transcends national boundaries, and that time-scales may relate to individual trajectories of past, present, and hoped-for futures. huot and liberté-rudman ( ) , analyzing the interplay of occupation, place, and identity, propose that individuals perform their identity in relation to place and occupation. this resonates with our results and the dynamic nature of the judgement individuals expressed of the place where they live and of the (now imagined) place they once left, and to which they long to return. the status of place shifts through time, as a manifestation of changes in context, occupation and identity. place-based co-produced climate services in such situations need to be reinvented in order to offer information that is dynamic, reconfigurable, and multi-layered. this is another central challenge for the climate service co-production research agenda. what did we learn by reaching out to a community for whom climate issues were not central? we learned that things are not what they seem; at least when one is "co-producing placebased climate services for action." "places" have multiple meanings, are not bounded, and depend very much on personal experience and mobility. the conceptualization of climate services, and the potential for co-production, depends on the reference discourse one mobilizes. climate services may generate many things: from the reproduction of a dominant liberal narrative emphasizing individual responsibility to a unique opportunity to contribute to justice and the redistribution of power. and "action" in this case entailed being mobilized to co-produce an anniversary celebration and the corresponding theater play, along with a stronger partner community as a result. if we return to our original line of questioning, "how and with what results might place-based climate service co-production be enacted within a community for whom climate change is not a locally salient concern?", we have some answers. in order to engage with a community in a climate service co-production exercise despite the community's seeming lack of interest in climate issues, we took the long way around. we engaged in relationship-building and making our skills available for many purposes while progressively connecting with the community, its concerns, interests, and finding intersections with climate issues. we were transparent in terms of our interest in climate concerns, yet we kept that agenda on the back burner while accepting to be mobilized ourselves around the community's more pressing issues. with what results? from the development of a trust-based relationship with the community to the building of a stronger community, this experiment allowed us to question the dominant paradigm that may be crippling for climate service co-production: the assumption that climate and weather are evident parts of the fabric of everyday life; that it is not always necessary to be explicitly focused on climate to be able to co-produce climate services. these three points lead us to question the definition of climate services we used at the onset of our work and as a starting point for this paper. paraphrasing vaughan and dessai we are inclined to propose a working definition of climate services that will need further ground-truthing: the aims of climate services are to provide people and organizations with timely, tailored climate-related knowledge and information that they can use to reduce climate-related losses and enhance benefits, including the protection of lives, livelihoods, and property, as well any process designed to reinforce the ability to: these conclusions seem to indicate that it might be worth considering integrating climate service coproduction into all community development activities. preparing for a changing climate and preparing the requisite knowledge base should be part of the everyday routines of local development, especially in neighbourhoods with a long list of seemingly more urgent concerns. they might be the hardest hit by climate change. cultural dimensions of climate change impacts and adaptation adaptation to climate change or non-climatic stressors in semi-arid regions? evidence of gender differentiation in three agrarian districts of ghana art-eco-science. field collaborations. antennae: the journal of nature in visual culture life on thin ice: insights from uummannaq, greenland for connecting climate science with arctic communities adaptation to climate change in coastal communities: findings from seven sites on four continents a climate of collaboration: environmental scientists urge artists to humanize the stories behind the research. american theatre predicting marine phytoplankton maximum growth rates from temperature: improving on the eppley curve using quantile regression portrait of a climate city: how climate change is emerging as a risk in co-production in climate change research: reviewing different perspectives toward a multi-faceted conception of co-production of climate services participatory arts and affective engagement with climate change: the missing link in achieving climate compatible behaviour change? patterns of thermal limits of phytoplankton learning about community capacity in the fundy model forest. the forestry chronicle gestes d'humanités: anthropologie sauvage de nos expériences esthétiques whose voices? whose choices? reflections on gender and participatory development adaptation planning in france: inputs from narratives of change in support of a community-led foresight process. climate risk management l'invention du quotidien creating usable science: opportunities and constraints for climate knowledge use and their implications for science policy arts, sciences and climate change: practices and politics at the threshold servitizing climate science-institutional analysis of climate services discourse and its implications mosaic patterns of thermal stress in the rocky intertidal zone: implication for climate change the performances and places of identity: conceptualizing intersections of occupation, identity and place in the process of migration climate change : impacts, adaptation, and vulnerability ipcc working group ii contribution to ar integrated science and art education for creative climate change communication environmental history and the concept of agency: improving understanding of local conditions and adaptations to climate change in seven coastal communities art and climate (change) perception: outline of a phenomenology of climate narratives of change and the co-development of climate services for action. climate risk management the role of place-based narratives of change in climate risk governance an attempt at a "compositionist manifesto waiting for gaia. composing the common world through art and politics. paper presented at the lecture given for the launching of speap the co-production of science and policy in integrated climate assessments observed and projected sea surface temperature seasonal changes in the western english channel from satellite data and cmip multi-model ensemble weather report: art and climate change local narratives of change as an entry point for building urban climate resilience. climate risk management transdisciplinary global change research: the co-creation of knowledge for sustainability where does climate fit? vulnerability to climate change in the context of multiple stressors in funafuti representing nature: art and climate change the role of local knowledge in adaptation to climate change the precipice: existential risk and the future of humanity transdisciplinary co-production: designing and testing a transdisciplinary research framework for societal problem solving impacts of climate change on european marine ecosystems: observations, expectations and indicators modeling the response of populations of competing species to climate change place attachment and memory: landscapes of belonging as experienced post-migration the climate of science-art and the art-science of the climate: meeting points, boundary objects and boundary work visual art as a way to communicate climate change: a psychological perspective on climate change-related art environmental perception: international efforts does activist art have the capacity to raise awareness in audiences?-a study on climate change art at the artcop event in paris seventy years' observations of changes in distribution and abundance of zooplankton and intertidal organisms in the western english channel in relation to rising sea temperature is it really just a social construction?: the contribution of the physical environment to sense of place global change and climate-driven invasion of the pacific oyster ( crassostrea gigas ) along european coasts: a bioenergetics modelling approach the politics of co-production: participation, power, and transformation. current opinion in environmental sustainability prévoir l'imprévu climate services for society: origins, institutional arrangements, and design elements for an evaluation framework identifying research priorities to advance climate services what can climate services learn from theory and practice of co-production art and climate change: contemporary artists respond to global crisis a systematic review of co-creation and co-production: embarking on the social innovation journey we thank the reviewers and the guest editor for the care taken in the process of reviewing our manuscript. this paper was made in the course of the cocliserv project figure : kerourien's regional context (a); detailed map of the neighborhood (b) with the location of two representative sites: c : the water-tower, c : the builders' bar in , with cows grazing. key: cord- - wnp sv authors: von der gracht, heiko a.; darkow, inga-lena title: scenarios for the logistics services industry: a delphi-based analysis for () date: - - journal: int j prod econ doi: . /j.ijpe. . . sha: doc_id: cord_uid: wnp sv the logistics services industry will be significantly affected by future developments throughout the world. therefore, developing future scenarios is an important basis for long-term strategy development. nevertheless, research exposes that there is a lack of awareness among logistics researchers and practitioners about future scenarios. in this paper, we apply scenario planning and present the findings of an extensive delphi-based scenario study on the future of the logistics services industry in the year . the major contribution of our research is the development of probable and unforeseen scenarios of the future which may provide a valuable basis for strategy development in the logistics services industry. the future of the logistics services industry will be faced with many obstacles as well as opportunities. the industry is currently experiencing strong growth rates, but is also confronted with major challenges in an increasingly complex and dynamic environment. intensifying globalisation, stronger competition, higher customer demands and resource scarcity are just a few of the factors that lead to a more turbulent and uncertain environment. given the potential negative impact of these factors, an analysis of future requirements is required to foster innovations in logistics in order to maintain competitiveness and the ability to adapt to changes (halldó rsson and ková cs, , p. ; flint et al., , pp. - ; soosay and hyland, , p. ; . scenario planning has been identified as one of the most appropriate approaches for long-range planning and to support decisions in uncertain situations (courtney et al., , p. ; schoemaker, , pp. , ; phelps et al., , p. - ; powell, , p. ) . the positive impact of its adoption has been proven empirically. in a broader sense, or more studies have examined a positive relationship between long-range planning and corporate performance over the past four decades (see e.g. ansoff et al., ; miller and cardinal, ; rhyne, ) . recently, an increasing number of authors have also highlighted the high value of scenario planning for logistics, primarily due to the rapid changes in the competitive environment and the fast-paced growth of the logistics industry (see e.g. piecyk and mckinnon, ; boasson, , p. ; spekman and davis, , p. ; waters, a, p. ; burbank and ways, ; shapiro, ) . nevertheless, an extensive literature review, as well as empirical research, demonstrates that scenario planning has not been widely used in logistics as yet, both in logistics research and industry practice . in this paper, we develop scenarios that describe potential long-term developments of the logistics environment and thereby support logistics executives in developing long-term strategies. these scenarios can support and guide managers in defining strategies contingent to potential future developments or in testing the robustness and appropriateness of strategies that are already in place. the first step in scenario planning is to systematically develop consistent and plausible scenarios. we present the results of an extensive expert-based scenario study on the future of the logistics services industry in . two specific research questions directed the design and execution of our study: ( ) how will the macro-environment (political/legal, economic, socio-cultural, and technological structure) of the logistics services industry change by ? ( ) how will the micro-environment (industrial structure) of the logistics services industry change by ? scenario development was based on a two-round delphi survey with ceos and strategy experts of the top logistics service providers in germany. in order to do so, projections were structured according to pest-analysis (political, economical, contents lists available at sciencedirect journal homepage: www.elsevier.com/locate/ijpe socio-cultural, and technological conditions related to research question ) (see wilson and gilligan, , p. ) and michael e. porter's ''five forces model'' (porter, ) (related to research question ). these projections include aspects such as the global energy consumption, resource scarcity, labour shortage, the role of emerging and developing countries, urbanisation, demographic change, social responsibility, global warming, digitisation, global networks, and large-scale outsourcing. the experts which participated in the delphi study assessed each of these projections in terms of the probability of occurrence, the potential impact on the industry and their desirability. based on these assessments and numerous verbal specifications and comments from the participants, different scenarios were developed. probable scenarios for the future of the logistics services industry in were developed based on projections with high probabilities of occurrence and consensus among experts; these included, for example, projections about the diminishing economic gap between emerging markets and developing countries and the still unresolved energy supply problem to foster globalisation. furthermore, we examined surprising or unexpected scenarios, so-called discontinuities, with a low probability of occurrence but with a high impact on the industry; these include, ''fabbing'', terrorist attacks, and the spread of pandemics. the remainder of our paper is organised as follows: we begin with a review of the literature relevant to our research, followed by a description of the research methodology. subsequently, we present our findings with respect to probable scenarios and unforeseen events. finally, we conclude by delineating various implications and further research avenues. the application of scenario planning to the business environment is a relatively new phenomenon (bradfield et al., , p. ) . scenarios are typically defined as internally consistent, plausible, and challenging narrative descriptions of possible situations in the future, based on a complex network of influencing factors (gausemeier et al., , p. ; van der heijden, , p. ) . scenario planning consists of two main parts: first, scenarios are developed through a systematic process of picturing and rehearsing future situations; second, strategic planning is based on the outcome of scenario development (bishop et al., , p. ; lindgren and bandhold, , p. ) . the major contributions of scenario planning include thinking in alternatives, enhancing a planners' perception, and offering a structure for dealing with uncertainty (van der heijden et al., , pp. - ) . varum and melo ( ) have recently presented results of an extensive bibliometric study on scenario planning publications in scientific journals. furthermore, an analysis of the various scenario foci revealed that a large portion ( %) concentrated on individual companies, followed by territories (approximately %) and specific industries (approximately %). however, the most striking result of varum and melo's ( ) research was that % of all scenario articles were published after the year , which confirms a substantial increase in academic research in this field recently. based on existing literature, we can identify different schools of thought in scenario planning: important representatives of these different schools are the global business network (see schwartz, ) , the stanford research institute (see e.g. ralston and wilson, ) , and the wharton business school (see schoemaker, ; schoemaker and mavaddat, ) . more specifically, the schools have either an intuitive-creative approach or a mathematical-logical approach to develop a scenario. provides an overview of the most relevant literature on scenario planning that is specifically related to logistics. in this table, we only list articles with a minimum time horizon of years and an empirical approach (e.g. through expert interviews or surveys) to data gathering. the different research contributions are classified by type, focus, planning horizon in years, methodology, and content. the overview of relevant articles for logistics reflects the general trend in publication patterns, as revealed by varum and melo ( ) . the number of publications has steadily increased for years. in terms of the planning horizon, we can observe a concentration of papers that considers either a range of - years or a planning horizon of more than years. this development reflects the need for a more profound and systematic approach to manage long-term planning in the volatile and uncertain environment of the logistics services industry. the trend towards globalisation has steadily increased with the effect that supply chains have become longer and more complex (ballou, , p. ) . recent research identified three major trends relevant for the logistics industry: outsourcing of logistics services; more severe competition; and differentiation or competitive advantages achieved through the added value offered to the customer (grant et al., ; waters, b) . grant et al. and waters expect that companies will go on to focus on their core competences. as in the course of cost reduction and flexibility improvement, the vertical integration will further be reduced. on the other hand, the regional scope of production is still expanding. therefore, information and goods flows have to be synchronised on a global level, leading to high complexity in the system. managing these systems efficiently is one of the major challenges for the logistics services industry and reflects the need for long-term planning and scenario planning. in general, scenario publications often have a quantitative focus, building on oil price development, gdp (gross domestic product) growth or transport volumes (see e.g. european community, ; stead and banister, ; sviden, ) . many scenarios actually include forecasts through trend extrapolations of historical data. a few publications exhibit a qualitative focus, i.e. scenarios based on a narrative description of the future (see e.g. institute for mobility research (ifmo), research (ifmo), , . this may be due to the fact that most of the scenario studies were intended to serve as a basis for decision makers in public policy. especially in logistics, scenario planning often focuses on macro-environmental aspects, such as infrastructure, roadwork, transportation markets, and policies (see e.g. piecyk and mckinnon, ; european community, ; stead and banister, ) . in the protrans project, funded by the european commission, scenarios were developed with a focus on intermodality in the european logistics services industry. two models for the focused field of intermodal transportation were developed, which were considered in a best, average and worst case simulation (protrans, ) . hardly any studies exist which consider industry scenarios to support decision making in companies (see e.g. bergman et al., ) . furthermore, many studies follow a classical, functional understanding of logistics, i.e. transportation, handling, warehousing (see e.g. duin et al., ; english and keran, ; european community, ) , and scenario research so far has not focused on the logistics services industry taking a holistic, supply chain perspective into consideration. our research is a first step in closing this research gap. we develop future scenarios that logistics service providers can use as a basis and starting point for strategy development. we integrate the delphi technique into scenario planning for expert-based scenario development. the delphi rounds are based on evaluating potential developments until within the macroenvironment and the logistics market structure, as suggested by our two research questions. the research objective is to develop qualitative-oriented industry scenarios while maintaining a holistic, supply chain perspective on the logistics services industry. scenario development focuses on the micro-and macro-environment of the industry. as indicated in the introduction, we used the pest-analysis (see wilson and gilligan, , p. ) and michael e. porter's five forces model (porter, ) to investigate the future of logistics services. the following two research questions were addressed: ''how will the macroenvironment (political/legal, economic, socio-cultural, and technological structure-pest) of the logistics services industry change by ?'' and ''how will the micro-environment (industrial structure) of the logistics services industry change by ?'' we base our research on the multi-stage process proposed by bood and postma ( , p. ) . the development of delphi-based scenarios is an approach that has been explicitly recommended by numerous authors because the delphi process is easy to integrate into the scenario development process and delphi delivers valuable, valid, and reliable data for scenario construction (see e.g. kameokaa et al., , pp. , ; loveridge, , p. ; rikkonen, ) . the delphi method attempts to systematically develop expert opinion consensus about future developments and events which are formulated as projections, i.e. short and concise future theses. it is a judgmental forecasting procedure in the form of an anonymous, written, multi-stage survey process, where feedback of group opinion is provided after each round (delbecq et al., , p. ; linstone and turoff, , p. ; rowe and wright, , p. ) . the delphi process we employed is based on the classical procedure from rand corporation, which is the most approved and accepted variant of the delphi approaches (dalkey, (dalkey, , chermack et al., , p. ) . fig. illustrates the individual phases of our research and shows how the delphi method was used for scenario development. first, we developed a set of projections based on the macroand micro-environments of the industry. subsequently, we identified, evaluated, selected, and recruited logistics experts for participation in the delphi survey. third, the projections were evaluated by the experts, followed by an interim analysis to calculate the statistical group opinion and aggregate arguments. fifth, experts were asked to revise first round answers based on the feedback of the interim results. sixth, we used the delphi data for scenario development. we decided to conduct two delphi rounds, thus including one feedback and possible revision of first round answers. this approach guaranteed that research fatigue was kept as low as possible, which, in turn, assured a higher response rate and validity of the data (mitchell, , p. ). in addition, numerous researchers have revealed that the major opinion of the study changes over time and, therefore, the most reliable study value occurs after the first iteration (see e.g. rowe et al., , p. ; woudenberg, , p. ) . we recognised that this approach may not lead to consensus for all projections. finally, the answers were analysed and used for scenario development. the latter included desk research, scenario writing, discontinuity analysis and an expert check for plausibility and consistency. a planning horizon of nearly years was chosen in order to fully distance ourselves from all planned and fixed decisions and to promote thinking ''out-of-the-box''. the scenarios focussed on the german logistics services market due to its central role in europe: the largest market in europe and the highest density of global players of the logistics services industry (klaus and kille, ) . for the empirical part of the scenario study, we decided to concentrate on the largest organisations to guarantee a global perspective across all modes of transport. overall, the participating experts come from organisations, equalling % of the cumulative turnover of the top logistics service providers in germany. researchers agree that standardisation and pretesting may be considered the two most effective means to ensure reliability in delphi research (kastein et al., , p. ; okoli and pawlowski, , p. ) . standardisation was, in fact, implemented in all of our delphi and scenario activities. moreover, the definition of research scope and aim, the structuring of the scenario field, expert selection, development of projections, and interim analysis followed phase-based standard procedures. in addition, the entire survey process was strongly standardised since it was planned and executed in line with the total/ tailored design method (dillman, (dillman, , . in the following discussion, we provide a more detailed explanation of the research methodology. the set of projections are listed to provide a better understanding of their nature and content before we explain how they were derived. the delphi survey consisted of projections on the future of the logistics services industry in (see table ). since projections were added and modified during the interim analysis, the final list of projections includes items. input for the development of our projections came from six sources (see table ). the exploitation of several sources for developing projections, as performed for our research basis, is recommended in literature (gausemeier et al., , p. ) . ( ) an internal workshop was organised with five academics from an scm research centre in germany. as a starting point, the workshop included a brainstorming session which resulted in future events and development factors. these were grouped into broad topics. ( ) in addition, an external workshop was held at a german logistics conference in which students, researchers and practitioners at the authors' university participated. twenty table final list of projections in scenario study. description: projections that have been evaluated in the delphi research according to their probability, impact, and desirability for . political-legal the problem of energy supply (e.g. scarcity of fossil fuels, nuclear power) remains unsolved globally the almost entire recycling of products and scrap within the value chain (''reverse logistics'') has become a legal regulation source-based allocation of costs from the usage of natural resources (pollution, exhaustion of natural resources, etc.) has been accomplished to a large extent international barriers of trade are significantly lower than compared to the year intensified climate protection regulations have increased the attractiveness of rail and sea transportation the absolute national investments in traffic infrastructure have significantly decreased in real terms increasing international harmonisation has led to global alignments of political and legal conditions economic global sourcing, production and distribution are common practice in almost all markets and value chains worldwide the quality of a company's global networks and relationships has become the key determinant of competitiveness many developing and emerging countries have narrowed the gap to the industrial nations by economically catching up in the tertiary and quaternary industry sectors the demand for local goods and services has significantly increased, primarily due to resource scarcity, environmental pollution, and the assimilation of living standards between developing/emerging countries and the industrial nations global standards and norms have been established that assure cost optimised planning, control and execution of international transports and their respective information flows the cost factor ''labour'' has been displaced by the factor ''access to resources'' leading to relocations of production to resource sites socio-cultural customer demands for convenience, simplicity, promptness, and flexibility have turned logistics into a decisive success factor for customer retention the supply and disposal among densely populated areas on the one hand and depopulated, rural regions on the other hand have led to location-dependent price structures for logistical services security costs and protection costs against industrial espionage, crime, and terrorism have disproportionately increased in the logistics industry the social responsibility has lost its national basis. logistics service providers increasingly make location and personnel decisions based upon global ethical standards and independently from national, cultural, and ethnical interests labour shortages for young, highly-qualified, mobile personnel have led to restraints in company growth the increasing knowledge expansion and the focus on knowledge generation, processing, and dissemination have led to a substantial ongoing relocation of production activities outside of germany (international division of labour) technological paperless transport has become common practice in national and international transport business due to the integration of physical and electronic document flows, almost all documents reach their receiver the same day innovations in transport logistics (e.g. new types of vehicles, alternative propulsion, innovative materials) have substantially contributed to the reduction of resource consumption new technologies in logistics obtain faster acceptance as compared to required information and communication technology demands large capital investments, which can hardly be raised by small and medium-sized logistics service providers alone biometric identification has become standard identification technology in logistics and enables fast and secure access controls intelligent, automated planning and control systems (agent systems, autonomous cooperation) are widely used in logistics innovations in transport logistics (e.g. new types of vehicles, alternative propulsion, innovative materials) have substantially contributed to a recovery of the current traffic infrastructure the area-wide utilisation of e-business has led to direct sales contacts between end customers and producers, which resulted in the displacement of wholesale and retail the decentralised production of many goods on-site in small-scale factories (fabbing, d printer, digitised products) has led to substantial structural changes in the logistics industry industrial structure the demand for high-value, customised logistics services has increased disproportionately small and medium-sized specialised logistics service providers have merged into global networks in order to stay competitive customers increasingly demand consultancy services from logistics service providers in order to cope with the increasing complexity and dynamism in their markets the market for digitised document logistics has largely displaced the market for physical document logistics alternative distribution networks have been established in the cep-market (courier, express, parcel). petrol stations, kiosks, and local public transport are increasingly used for pickup and delivery of parcels the consolidation phase among large logistics service providers has reached saturation so that the global mass market is divided among five to nine providers the volumes of classical logistics services (transport, handling, storage) have significantly increased large logistics service providers (more than employees, more than h million turnover) take longer planning horizons for their vision and strategy development into consideration and therefore increasingly use corresponding futures methodologies (e.g. scenario technique, early warning systems) customers increasingly take ecological aspects into consideration for their establishment of international logistics networks and the selection of logistics service providers the logistics industry is more strongly affected by large-scale outsourcing deals than in customers expect document logistics to be an integral element of the service portfolio of a logistics service provider service providers from adjacent industries (e.g. facility management, it-services, security services) increasingly enter the market for logistics services so that the classical borders between industry, retail and wholesale, and logistics services are blurred an e-mail survey among international top futurists, we asked for five keywords that come to mind when thinking about the future of logistics. purposive sampling was performed, based on databases of members of the world future society and association of professional futurists, to find the sample of futurists. the selection criteria were: technical specialisation in logistics-related fields of global issues; methodological specialisation in scenario planning; quantity and quality of publications; academic title; education; profession; and position in science or practice. these futurists identified influencing factors in order to prepare the projections on the future of logistics. ( ) in a similar fashion, experts from specialist trend and futures consultancies were interviewed. based on market research, organisations were identified, which offer scenario consultancy services in germany. the sample of organisations was used as a census. the experts within the organisations were selected based on the following criteria: long scenario planning experience and specialisation within the logistics field, if available in the organisation. in total, factors were identified and analysed. ( ) secondary data was reviewed through desk research, of which influencing factors could be determined. ( ) finally, the database of a futures consultancy provided factors. pretesting to ensure reliability as well as content and face validity were performed at two stages in the delphi process. first, after their initial formulation, the projections were assessed by five experts, which checked for completeness and plausibility of the content as well as methodological soundness. second, after completion of the questionnaire design, another pretest was conducted among six experts from industry and academia. similar to hypothesis development in survey-based research, the formulation of projections directly impacts the quality of the entire study (mić ić , , pp. - ) . to ensure methodological rigour we employed the following measures: first, the projections were checked for ambiguity and precise wording was used to guarantee specificity in formulation without including too many elements (salancik et al., , p. ) . second, we ensured the avoidance of conditional statements by making the primary question dependent on the fulfilment of a series of conditions or by urging experts to evaluate the two parts of the projection in the same manner, even if they had a different opinion on each statement. if a projection was formulated with conditions, it was split into two projections. third, a monitoring team, consisting of two researchers, separately checked and validated the contents of the analyses (turoff, , p. ) . fourth, the questionnaire was structured into clusters of topics to make it easy to follow, according to the terms in the pest-analysis, in addition to the structure of the logistics services industry (häder, , p. ) . we decided to include - participants, a recommended panel size for delphi surveys among a homogeneous group of experts that includes both quantitative and qualitative data collection (see e.g. parent e and anderson-parent e, , pp. - ; skulmoski et al., , p. ) . the improper selection of experts is considered the most severe validity threat in delphi research (creswell, , p. ; hill and fowles, , pp. , ) . in our study, we therefore followed a three-stage procedure including the identification of potential experts, the evaluation of identified experts, and expert recruitment. our initial pool of potential experts comprised members of the board and heads of strategy departments of the largest logistics service providers in germany. each one of the selected companies generated a turnover of more than h million in and most of these companies also belonged to europe's top logistics service providers. for each of the expert candidates, we determined a score to reflect their individual expertise. the scores were based on a set of criteria including the management level, academic background, job specialisation, education, functions inside and outside of the organisation, publications, and age (delbecq et al., , pp. - ; lipinski and loveridge, , p. ; mehr and neumann, , p. ) . in each company, the expert with the highest score was invited to participate in the study. if the expert was not willing to participate, the expert with the next highest scores was invited, and so forth. in total, experts ( . %) from of the top logistics service providers agreed to take part in the delphi survey. of the participants, ( . %) were members of the management board, whereas of the experts ( . %) were head of the strategy or corporate development department of their company. in cases ( . %), the initial target person delegated the questionnaire to other persons within the organisation who were considered to be more suitable. these experts predominantly came from marketing and innovation departments. all experts had at least years of experience within the logistics services industry; on average the experts had . years of industry experience (see fig. ). all experts took part in both delphi rounds, leading to a drop-out rate of %. the fact that all of the experts participated in the second round indicates a high level of satisfaction in terms of survey content and questionnaire design. it is reasonable to assume that a high level of satisfaction increases commitment and involvement, which inevitably results in high survey data quality. during the delphi rounds, the experts assessed each projection in terms of its expectational probability, impact on the industry and desirability for the year . the expectational probabilities were measured in percentages, industry impact on a -point likert scale, and desirability on a nominal scale with values ''desirable'' or ''not desirable''. the experts were asked to provide a written justification for each probability estimate. since it was unlikely that the experts would modify their assessment of impact and desirability, they were only asked to re-evaluate their initial assessment of the expectational probability in the second delphi round. after the first round, we performed an interim analysis based on descriptive statistics (mean, standard deviation and interquartile range-iqr ). we specifically checked for consensus, outliers and potential misunderstandings. the respective consensus criterion deducted from literature was an iqr of or less (see e.g. hahn and rayens, , p. ; raskin, ; de vet et al., ; scheibe et al., , p. ) . since the experts were asked to provide reasons for their probability estimates, the amount of qualitative data was large. in total, usable arguments, mostly written in whole sentences, were collected in the first round. these arguments were aggregated with a summarising content analysis. based on the interim analysis, the second questionnaire was developed; it included only those projections in which consensus was not achieved in the first round. in addition to each projection, the feedback included the group response and aggregated arguments. in the subsequent second round, each expert had the chance to revise first round answers. in the final analysis, only of items were missing, resulting in an exceptionally low missing value rate of . %. this low missing value rate indicates a high degree of involvement and commitment of the participating experts. therefore, it is reasonable to assume that the validity of the data is high. also, the low missing value rate, in combination with the fact that many comments were provided at the end of the questionnaire, is an indicator for a low level of fatigue. based on the evaluation of projections by the experts, we identified relevant scenarios of the future of the logistics services industry in . these included probable, extreme and unforeseen scenarios. the qualitative description of the most probable scenario is based on the experts' comments during the delphi rounds as well as desk research. this probable scenario will be presented in section . it has been criticised that many scenario studies exclude discontinuities or, in other words, ''wildcards'' (cornish, , p. ; grossmann, , p. ) . such events or developments can be characterised as having a low probability of occurrence, but a high impact on the decision field, e.g. the industry or the company. their selective inclusion helps to identify further alternatives, to increase the ability to adapt to surprises, and to test the robustness of strategies and decisions (mić ić , , pp. - ) . based on a further analysis of the experts' comments, eight wildcards were extracted, out of which three will be presented later. as recommended by van der heijden ( , p. ), a final expert check of the scenarios was conducted to ensure compliance with quality criteria. in addition, further desk research was conducted to support the plausibility and consistency of the scenarios. illustrated. an analysis of the expectational probabilities revealed a decrease in the standard deviations (sd) of all projections that had been evaluated in both rounds. in line with the fundamental rational of the delphi method, the feedback of the statistical group response and the experts' comments led to a convergence among the expert panel's opinions, implying that the participants more strongly agreed on their estimations. the strongest convergence was measured for projection (paperless transport). its standard deviation decreased by . %. projection (agent systems), in turn, recorded the weakest change at . %. consensus was measured after two delphi rounds for of the projections ( . %). in total, for of the projections ( . %) consensus was already achieved in the first round. especially the analysis of the survey data along the two dimensions ''expectational probability'' and ''impact'' provides valuable insights. in fig. , we illustrate the results for all of the projections in the form of a scatterplot. each number represents the corresponding projection listed in table . a diamond represents a projection where consensus among the experts was achieved. a black dot represents those projections, where consensus among the experts was not achieved. the distribution of projections in fig. provides interesting insights. it can be observed that most of the projections have an average impact of or higher, as well as an average expectational probability of % or more. in general, this demonstrates the relevance of the projections developed in the first phase within the research project. the results indicate that the a priori formulation and selection of projections have accurately taken place. another interesting result can be observed with respect to the consensus/dissent distribution. the results clearly demonstrate that projections, where consensus was not achieved, have an average expectational probability of - %, whereas consensus projections predominantly exhibit a probability of - %. this finding is rather common in delphi studies (see e.g. ogden et al., , pp. - ) . by its nature, dissent is more likely to be associated with projections for which the future development is still difficult to assess. clearly, for projections with high expectational probabilities (above %), the experts have a higher level of agreement. further interpretation of the results will be provided in section . . one of the major contributions of this research is the development of a scenario for the most probable future in the logistics services industry in which considers changes in the macro-and micro-environments. fig. illustrates an interpretive clustering result for the probable scenario of . in total, projections can be grouped that are characterised by high mean expectational probability and consensus among the expert panel, see table . in three cases, the consensus was very strong, i.e. the interquartile range was . the projections (developing countries) and (cep-market) have, with %, the lowest mean expectational probability of the projections and, therefore, represent the left border of the cluster. interestingly, the group includes at least one projection from each of the five groups (political-legal, economical, etc.), resulting in a diverse mix of scenario elements. five of the projections are related to the industrial structure, capturing porter's five forces. almost all projections were found desirable by the majority of experts. in cases, % or more of the panel members assessed an occurrence as desirable. projection (global networks) achieved a desirability of . %, which is still very high. projection (energy supply), however, is found desirable by only . % of the experts. the picture of the probable future is, to a large extent, also a picture of a desirable future. we now proceed with the results of our scenario. the projections were analysed based on the experts' comments collected during the delphi rounds. for each of the projections, the experts gave major arguments for low and high probability. furthermore, the numbers of entries which experts provided for each argument is listed. table describes the scenarios including a conclusion per projection. the previous scenario development gives insights into the most probable future for the logistics services industry in . as recommended by many researchers, the analysis of eventualities with low probabilities but a high impact on the industry, known as ''wildcards'', should be an essential aspect of scenario development (cornish, , p. ; grossmann, , p. ) . we, therefore, decided to conduct a discontinuity analysis within the scope of this study. the delphi data formed the overall fundament of which the general framework was developed. a wildcard scenario looks at the consequences of one single surprising event or development. such incidents could be the result of technological breakthroughs, social tension, or political overthrows, and have to be considered infinite in time. in his book, ''out of the blue: how to anticipate big future surprises'', the futurist john l. petersen ( ) discusses wildcards of the future, ranging from climatological and space-based threats to biomedical or geopolitical surprises. our wildcard scenarios picture possible situations in the future for which logistics service providers might prepare contingency plans to better prepare themselves. analysis of wildcard scenarios supports companies by making them more aware of events and developments which are not very likely to occur, but could have fundamental impact on the logistics services industry. based on an analysis of our delphi experts' comments, we selected eight wildcards for the logistics service industry for analysis. for example, the comments in the projection about the impact of terrorist attacks (projection ) were used to elaborate on the wildcard ''terrorist attacks on logistics networks''. the projection was selected because there was no consensus within the expert panel but probability and impact were rather high. the wildcard ''fabbing'' (projection ) was chosen because experts did agree in their evaluation, but allocated a low probability and a medium impact on the industry. the third wildcard ''spread of a pandemic through logistics networks'' was an outcome of the experts' arguments within several projections. the remaining five wildcards were identified in a similar way: return of protectionism; dictatorship of data protection (e.g. prohibition of exchange, storage, and internal use of any type of individual-related data); worldwide system failure (information and communication system breakdowns); the rise of revolutionary transportation technologies; fully automated, selfmonitoring logistics. desk research revealed additional information on the selected wildcards. the full presentation of all of the eight wildcards is beyond the scope of this paper. however, we would like to briefly present the key content of three of the eight wildcards (see table the problem of energy supply (e.g. scarcity of fossil fuels, nuclear power) remains unsolved globally global sourcing, production and distribution are common practice in almost all markets and value chains worldwide the quality of a company's global networks and relationships has become the key determinant of competitiveness many developing and emerging countries have narrowed the gap to the industrial nations by economically catching up in the tertiary and quaternary industry sectors customer demands for convenience, simplicity, promptness, and flexibility have turned logistics into a decisive success factor for customer retention paperless transport has become common practice in national and international transport business due to the integration of physical and electronic document flows, almost all documents reach their receiver the same day the demand for high-value, customised logistics services has increased disproportionately small and medium-sized specialised logistics service providers have merged into global networks in order to stay competitive customers increasingly demand consultancy services from logistics service providers in order to cope with the increasing complexity and dynamism in their markets the market for digitised document logistics has largely displaced the market for physical document logistics alternative distribution networks have been established in the cep-market (courier, express, parcel). petrol stations, kiosks, and local public transport are increasingly used for pickup and delivery of parcels the problem of energy supply (e.g. scarcity of fossil fuels, nuclear power) remains unsolved globally low probability the technological innovations until are not considered efficient enough to compensate the increase entries alternative sources of energy will be used more often in the future entries the extraction of difficult-to-access fossil fuels will become easier and less expensive entries high probability due to energy sector lobbying, conflicts of interest in international negotiations are likely to hinder the development of a turnaround in the use of energy entries the combination of progressing resource depletion and increasing demand for energy by developing and emerging countries will increase entries new technologies and energy savings in industrialised nations will not be sufficient to compensate the increase in demand entries increasing costs for fuel will give rise to high transport costs since the development of resource-saving energy will not be finished yet. due to the increasing energy costs, operating expenses of logistics property, such as warehouses, will also rise. this will be noticeable in the field of temperature-controlled logistics in particular, due to the higher energy consumption. an emerging solution will be the installation of solar cells on the roofs of warehouses and distribution centres. nevertheless, due to the energy problem, logistics services are likely to be more cost-intensive in global sourcing, production and distribution are common practice in almost all markets and value chains worldwide low probability regional structures offer advantages in some markets entries high probability in order to remain competitive, companies cannot ignore the growing advantages, which result from globalisation entries the megatrend started years ago, will intensify over the next years, and is irreversible entries conclusion for , it is also considered highly probable that global sourcing, production, and distribution will have become common practice in almost all markets and value chains worldwide. the unsolved problem of energy supply is not expected to stop the globalisation movement the quality of a company's global networks and relationships has become the key determinant of competitiveness low probability technologies and optimised information flows make networking easier and thereby is one of the less important competitive factors entries the creation of performance will become less important, rather relationships make the difference entries most industries will be organised according to divisions of labour entries know-how inter-linked with production advantages is the success model of the future. networking is the main prerequisite in order to generate knowledge and use it profitably entries it is very likely that the quality of a company's global networks and relationships will be the key determinant of competitiveness in . for this reason, small and medium-sized, specialised logistics service providers will have merged into global networks many developing and emerging countries have narrowed the gap to the industrial nations by economically catching up in the tertiary and quaternary industry sectors low probability the catch-up process will be slower entries brain drain will hinder the development of the quarternary sector entries high probability high degree of economic growth entries higher levels of education and salaries entries process already underway, especially in the tertiary sector entries conclusion the ongoing globalisation will undoubtedly produce winners and losers in the coming years. winners will, to a large extent, come from the group of developing and emerging countries. a multitude of these countries is expected to narrow the gap to industrial nations by economically catching up in the tertiary and quarternary industry sectors. strong economic growth, increases in the levels of education and wages, as well as it offshoring activities are current indicators. the major drivers will be resource abundancy, e-business, and long-term western knowledge transfer. this development, however, also means that the environment of globally-active logistics service providers is becoming more competitive customer demands for convenience, simplicity, promptness, and flexibility have turned logistics into a decisive success factor for customer retention low probability price remains a primary factor in decision criteria entries buying power and payment reserves could develop insufficiently entries high probability logistics offers opportunity for differentiation if products are similar entries a significant trend is already apparent in all four areas entries convenience, simplicity, promptness, and flexibility will become more and more important entries conclusion for , customers are expected to be more sophisticated, segmented, and demanding in terms of convenience, simplicity, promptness, and flexibility. it will be even more imperative for logistics service providers to engage in new service developments in order to adapt to the changing customer needs. logistics will become a decisive success factor for customer retention paperless transport has become common practice in national and international transport business low probability legal and safety regulations will increase entries emotional hurdles have to be overcome entries high probability technical capability already exists entries standardisation of it and interfaces will simplify integration entries conclusion companies will strive for huge cost-saving potentials and process-related optimisations. it is expected that increasing internet security, higher data transmission capacities, as well as deregulation of legal requirements will further drive the substitution. paperless transport is likely to become standard in national and international transport business due to the integration of physical and electronic document flows, almost all documents reach their receiver the same day low probability heterogenity in the transport industry and numerous interfaces make the implementation of an integrated system difficult entries legal and saftety requirements are necessary in sub-areas entry high probability the technical capability exists entries paperlessness is already widespread in cep services entries high cost-saving potentials exist entries following table provides a summary of their important elements and allows for easy comparison and analysis. fabbing (wildcard ) could, for example, revolutionize production fundamentally. currently, the massachusetts institute of technology (mit) and the fraunhofer alliance ''rapid prototyping'' are working intensely on this topic. although from today's viewpoint it is unlikely that it would be prevalent by , fabbing cannot be ruled out. some historical events show that (not) considering wildcards can influence decision making for companies significantly: the advantages of pcs were underestimated for a long time. ken olsen, founder of the digital equipment corporation, said in that there was no reason why someone would want to have a computer at home. as we know today, by the year , years later, the u.s. census bureau counted . % of u.s. households with a computer and . % with internet access. logistics service providers might also consider the possibility of terrorist attacks in planning (wildcard ). since '' / '' (september , ) , the fear of such attacks on logistical networks has grown, particularly to the most important ship routes and seaports. the attack on the french ocean vessel ''limburg'' along the coast of yemen in october proved that these fears are realistic: a boat filled with explosives rammed a hole in the starboard of the ship and , of the , barrels of oil on board poured out into the sea. the economic costs of disruptions in sea transport can be dramatic. logistics service providers might develop alternative it is expected that, through efficient document logistics solutions, a seamless integration of physical and electronic document flows will have become standard. against this background, it is likely that almost all documents will reach the receiver the same day. such business models are already technically feasible today and ongoing standardisation in information and communication technology drives us towards such a future. thus, logistics services will be provided faster in the demand for high-value, customised logistics services has increased disproportionately low probability higher costs will result from customised services entries high probability there will be an increase in customer demands entries stronger networking will be required entries the complexity will increase entry conclusion logistics services are also likely to be more customised in . expected changes in customer demands towards more convenience, simplicity, promptness, and flexibility have already been noted before. in line with these changes, the demand for high-value, customised logistics services is considered to increase disproportionately in the future. this is primarily attributed to the increasing complexity and diversity of networked business processes. the relocation of production and outsourcing initiatives are considered the key drivers of the development. in particular, reductions in the value added increase the demands for effective and efficient logistics networks. in this context, logistics performance is increasingly seen as competitive factor small and medium-sized , specialised logistics service providers have merged into global networks in order to stay competitive low probability integration problems will occur entries special interests by individual providers entries high probability it will be possible to illustrate global supply chains entries the financial performance and cost-optimisation potentials will improve entries conclusion small-and medium-sized, specialised logistics service providers will have merged into global networks. it will allow them to offer services beyond their regional niche portfolios and provides them with financial power. in addition, customers will increasingly ask for global presence and network capabilities. cost optimisation is seen as an additional driver of the merger process. thus, the logistics services industry will be more global and more networked in customers increasingly demand consultancy services from logistics service providers in order to cope with the increasing complexity and dynamism in their markets low probability customer companies know their markets better than logistics service providers entries high probability increasing complexity increases the demand for consulting entries logistics service providers have branch-specific and geographical characteristics know-how at their fingertips entries logistics service providers have cross-industry knowledge entries conclusion uncertainty in business will have steadily increased, leading to more severe risks than before. due to the global cross-industry activities, logistics service providers are building up a comprehensive knowledge base that they can use for consultancy services. in , it is likely that many of their customers will demand not only classical logistics services but also consultancy in order to cope with the increasing complexity and dynamism in their markets. this situation may primarily be attributed to three developments. first, the globalisation and the international division of labour will have reached new, higher levels. second, the ''care factor'' will be more distinctive as a consequence of extensive outsourcing initiatives. third, the likely occurrence of this projection is seen as a concomitant phenomenon of the increasing information overload. thus, logistics service providers are expected to act in more complex and more dynamic environments the market for digitised document logistics has largely displaced the market for physical document logistics low probability there are application fields in which physical documents are superior entries sub-areas will continue to be protected by legal obstacles entry high probability cost and processing advantages will exist entries safety standards and data processing capacities will increase entries conclusion the logistics business will be more digitised in the future. document logistics will play an even greater role in than today. presumably, the market for digitised services will have displaced the market for physical document logistics to a large extent. nevertheless, in some business segments, such as direct marketing and private communication, physical document logistics will still be preferred over digitised procedures. the major challenge of digitisation will be to keep up with the newest technological standards in order to satisfy customer demands and to guarantee the trouble-free integration in global networks alternative distribution networks have been established in the cep-market (courier, express, parcel). petrol stations, kiosks, and local public transport are increasingly used for pickup and delivery of parcels low probability established networks in germany are very strong entries punctuality, reliability and endurance of alternative networks are not safeguarded entry high probability there will be many opportunities for cost savings entries the quality of service will improve entries conclusion alternative distribution concepts for the last mile will additionally create more convenience for the customer by new, time-independent pickup and delivery processes transport routes and train their employees in order to respond to possible crises situations quickly. experts have been warning for years against wildcard scenario , i.e. the outbreak of a pandemic. some companies have indeed specialised in such scenarios and developed emergency plans in order to sustain operation to some extent. a notable german online magazine cited several statements from large corporations (becker, ) . for example, some large financial institutes, such as hsbc, plan home office work on a large scale in case of emergency or rely on external providers. deutsche post world net, in turn, reports of detailed emergency plans in agreement with health and regulatory agencies. since sars, several large industrial firms, e.g. bmw, have crisis plans in order to avoid production stops. however, various studies, such as deloitte & touche's annual pandemic preparedness survey, prove that most companies are not prepared for pandemics and have not worked out corresponding emergency plans. in our research, we aimed at closing a research gap with respect to scenario development in the logistics services industry. more specifically, two research questions guided our research: ( ) how will the macro-environment (political/legal, economic, socio-cultural, and technological structure) of the logistics services industry change by ? and ( ) how will the micro-environment (industrial structure) of the logistics services industry change by ? by using empirical research, we examined possible events and developments, identified major factors, and aggregated expert knowledge for the long-term future. our research makes four important contributions to the existing body of literature. first, we conducted a delphi survey within the german logistics services industry in order to determine the probability, impact, and desirability of projections on the future of this industry. in general, the delphi survey led to a convergence among the expert panel's opinion, implying that the participants strongly agreed in their estimations. for out of projections, consensus was reached; for projections consensus was already achieved in the first delphi round. most projections yielded an average impact on the logistics services industry of or higher ( -point likert scale) as well as an average expectational probability of % or more; consensus projections even - %. second, we conducted a scenario development process to picture the most probable future of the logistics services industry . five dominant themes can be identified that are likely to influence the macro-environment and industry structure in the future: the general notion towards strong social responsibility and ecological awareness; the intensifying pace of globalisation and its imperative for global networks; the shortage of young, qualified, and mobile personnel; the changing customer demands towards more convenience, simplicity, promptness, and flexibility; and the digitisation of business. the highly probable picture of table wildcard scenarios to describe eventualities and discontinuities. wildcard : personal fabricators direct fabrication of objects from computer models by using additive-fabrication-technologies, such as d printing and laser sintering the personal fabricator would be an affordable device for the production (fabrication) of goods in one's own home d printers are already available for $ (e.g. desktop factory, inc.) decentralisation for less complex consumer goods; consumer becomes ''pro-sumer'', i.e. producer and consumer in one, and is strongly integrated in development and production process strong increase in bulk transport of fabbing raw materials in some industries, manufacturers and retailers would become obsolete (cf. music industry) wildcard : terrorist attacks on logistics networks disturbance of networks have detrimental effects on the economy of a country sea trade is concentrated on a few straits where attacks would have dramatic effects strong dependency on maritime logistics infrastructure, e.g. % of the oil for japan, south korea, and china is transported through the strait of malakka terrorist attacks on oil tankers could block-off regions, e.g. a closure of the hub port singapore alone can easily exceed us$ billion per year from disruptions to inventory and production cycles (ho, , p potential for workplace absences due to illnesses is at a rate of at least % the world bank recently calculated that the mere occurrence of the bird flu in several east asian countries, which did not claim many lives, caused costs between . % and . % of the gdp nations and regional associations of countries would seal themselves off from potential regions of danger trade and tourism would be discontinued as with the outbreak of severe acute respiratory syndrome (sars) in asia in comprehensive state control and quarantine provisions would become effective production and supply chains would be interrupted, particularly just-in-time production the future is thus one of a more cost-intensive, complex, dynamic, competitive, digitised, global, networked, customised and faster logistics services business. third, we included analyses of discontinuities and surprising occurrences in our scenarios research to give further insights on possible changes in the macro-environment and industry structure for the logistics services industry. in fact, scenario planning might be of more relevance for logistics service providers in the future due to the turbulent business environment, which is highly susceptible to discontinuities. our discontinuity analysis came up with new, inspiring, and surprising issues although it was limited in its scope. the wildcard scenarios on fabbing, terrorism attacks, and pandemics illustrated that such analyses help to sensitise companies for events and developments which are very improbable, but might have fundamental impact on the business if they do happen. fourth, we focused on the application of the delphi method as a basis for scenario planning. although recommended by several authors, rigour is seldom discussed in detail. this study has drawn attention to issues of validity and reliability and proposes rigorous methodology to develop scenarios based on a delphi survey. the research was conducted in the form of a two-round expert-based scenario study among the top logistics service providers, of which participated. managerial contributions of our research primarily concern the generation of planning data and the exemplification of systematic and methodologically sound scenario development. the scenario data offers a starting point to customise specific long-term strategies for the company. for organisations already investing in environmental scanning, the delphi data can provide a validation or expansion of their own scans. a scenario transfer, i.e. the usage of the scenarios for decision support, may be either active or passive. while the former concerns the update or development of new strategies, the latter refers to testing existing strategies regarding their robustness. the wildcards are particularly suitable for developing contingency plans for the future. logistics planners may use our data as a basis for an extended wildcard analysis and the establishment or support of an early warning system. there are limitations to this research which also reveal possible avenues for further research. the research, and especially scenario development, is mainly based on qualitative research, even though we provide statistical data to support our qualitative findings. further quantitative data (e.g. with respect to cost implications and industry growth rates) may be included in the analyses to provide a more tangible basis for strategic planning. furthermore, the delphi study exclusively focused on the top logistics service providers in germany. future research might also examine the implications for small-and medium-sized companies and can also be extended to include other regions of interest. the delphi panel was additionally limited to experts, since it was the recommended size for a homogeneous group of experts and a questionnaire with qualitative information. however, future research might place more emphasis on a larger sample rather than on qualitative data, to identify scenarios that represent the perspective of the entire logistics industry, i.e. also manufacturing and retail. the delphi survey was limited to two rounds. as a consequence, several projections did not reach consensus. nevertheless, there was convergence among all of them. future research might continue with their evaluation and eventually find further consensus projections. the delphi survey aimed at collecting data for scenario development. it, therefore, excluded continuative analyses, such as of subgroups. future research might engage in the comparison of views of different stakeholders. it would, for example, be of interest to see where the expectations of logistics service providers and their customers differ and why. does planning pay? the effect of planning on success of acquisitions in american firms business logistics/supply chain management vogelgrippe-unternehmen schmieden notfallpläne für die pandemie managing the exploration of new operational and strategic activities using the scenario method-assessing future capabilities in the field of electricity distribution industry the current state of scenario development: an overview of techniques an evaluation of scenario planning for supply chain design strategic learning with scenarios the origins and evolution of scenario techniques in long range business planning scenario planning: a new paradigm in transportation decision making a review of scenario planning literature the economic costs of disruptions in container shipments. the congress of the united states logistics futures in europe-a delphi study. centre for logistics and transportation the wild cards in our future strategy under uncertainty research design: qualitative, quantitative, and mixed methods approaches the delphi method: an experimental study of group opinion. the rand corporation scenario-driven innovation management for logistics service providers the potentials of scenario planning for logistics service providers determinants of forward stage transitions: a delphi study group techniques for program planning: a guide to nominal group and delphi processes zukünftige transportkonzepte im kep-markt-kurier, express, paket. deutsche bahn ag, research and technology centre mail and telephone surveys: the total design method mail and internet surveys: the tailored design method crossimpact analysis of rfid scenarios for logistics the prediction of air travel and aircraft technology to the year using the delphi method foresight for transport: a foresight exercise to help forward thinking in transport and sectoral integration logistics innovation: a customer value-oriented social process strategic planning at united parcel service future potentials of rail-based cargo transportation for the courier, express and parcel-market szenario-management-planen und führen mit szenarien nd ed scenario management: an approach to develop future potentials lessons for process management, assessment and evaluation. paper presented at the eu-us seminar: new technology foresight the use of futures analysis for transportation research planning fundamentals of logistics management critical and strategic factors for scenario development and discontinuity tracing delphi-befragungen. ein arbeitsbuch consensus for tobacco policy among former state legislators using the policy delphi method the sustainable agenda and energy efficiency logistics solutions and supply chains in times of climate change the methodological worth of the delphi forecasting technique the security of regional sea lanes. institute of defense and strategic studies the future of mobility: scenarios for the year . institute for mobility research (ifmo), berlin. institute for mobility research (ifmo), . the future of mobility: scenarios for the year . first update a challenge of integrating technology foresight and assessment in industrial strategy development and policymaking delphi, the issue of reliability: a qualitative delphi study in primary health care in the netherlands top in european transport and logistics services-market sizes, market segments and market leaders in european logistics industry scenario planning: the link between future and strategy the delphi method-techniques and applications how we forecast: institute for the future's study of the uk foresight and delphi processes as information sources for scenario planning. paper presented at the iir conference in 'scenario planning the future of logistics in canada: a delphi-based forecast delphi forecasting project phenomenology of future management in top management teams strategic planning and firm performance: a synthesis of more than two decades of research the delphi technique: an exposition and application supply management strategies for the future: a delphi study the delphi method as a research tool: an example, design considerations and applications delphi inquiry systems emerging economic and technological futures: implications for design and management of logistics systems in the s out of the blue: how to anticipate big future surprises nd ed madison books does scenario planning affect performance? two exploratory studies forecasting the carbon footprint of road freight transport in how competitive forces shape strategy strategic planning as competitive advantage. strategic management the role of third party logistics service providers and their impact on transport the scenario-planning handbook-a practitioner's guide to developing and using scenarios to direct strategy in today's uncertain times the delphi study in field instruction revisited: expert consensus on issues and research priorities the relationship of strategic planning to financial performance utilisation of alternative scenario approaches in defining the policy agenda for future agriculture in finland the future of business logistics: a delphi study predicting principles of forecasting: a handbook for researchers and practitioners delphi: a reevaluation of research and theory the construction of delphi event statements the delphi method-techniques and applications when and how to use scenario planning: a heuristic approach with illustration profiting from uncertainty. strategies for succeeding no matter what the future brings scenario planning for disruptive technologies the art of the long view. planning for the future in an uncertain world research methods for business strategic planning: now more important than ever a review of the leading opinions on the future of supply chains. supply chain project working paper the delphi method for graduate research how to do strategic supply-chain planning driving innovation in logistics: case studies in distribution centres risky business: expanding the discussion on risk and the extended enterprise transport policy scenario-building future information systems for road transport: a delphi panel-derived scenario the delphi method-techniques and applications directions in scenario planning literature-a review of the past decades global logistics-new directions in supply chain management strategic marketing management: planning, implementation & control rd ed we would like to express our appreciation to all panellists for their valuable contribution to this scenario study. we would also like to thank professor kulwant s. pawar for his invitation to publish in this special issue of papers from the th international symposium on logistics, . in addition, we thank professor dr. richard pibernik for his valuable support and assistance. finally, we acknowledge the very useful comments and suggestions from our anonymous reviewers. key: cord- -hl ln r authors: tulchinsky, theodore h.; varavikova, elena a. title: planning and managing health systems date: - - journal: the new public health doi: . /b - - - - . - sha: doc_id: cord_uid: hl ln r health systems are complex organizations. they are often the largest single employer in a country, with expenditures of public and private money of – percent of gross domestic product. overall and individual facility management requires mission statements, objectives, targets, budgets, activities planning, human interaction, services delivery, and quality assurance. health organization involves a vast complex of stakeholders and participants, suppliers and purchasers, regulators and direct providers, and individual patients, and their decision-making. these include pyramidal and network organizations and ethical decision-making based on public interest, resource allocations, priority selection, and assurance of certain codes of law and ethical conduct. this chapter discusses how complex organizations work, with potential for application in health, and the motivations of workers and of the population being served. organization theory helps in devising methods to integrate relevant factors to become more effective in defining and achieving goals and missions. health systems are complex organizations and their management is an important concept in the new public health. health is a major sector of any economy and often employs more people in the industrialized countries than any other industry. health has complex networks of services and provider agencies, including funding through public or private insurance or through national health service systems. whether insurance is provided by the state or through private and public sources combined, skilled management is required at the macro-or national and the micro-or local level, including the many institutions that make up the system. management training of public health professionals and clinical services personnel is a requisite and not a luxury. planning and management are changing in the era of the new public health with advances in prevention and treatment of disease, population health needs, innovative technologies such as genetic engineering, new immunizations that prevent cancers and infectious diseases, prevention of non-communicable diseases, environmental and nutritional health, and health promotion to reduce risk factors and improve healthful living for the individual and the community. modern and successful public health also must address social, economic, and community determinants of health and the promotion of public policies and individual behaviors for health and well-being. the social capital and norms that promote cooperation among people are the basis of a "civil society" (i.e., the totality of voluntary, civic, and social organizations and institutions of a functioning society alongside the structures of governmental and commercial institutions). health systems are ideally knowledge-and evidence-based in using technologies available in medicine and the environment to promote the health and well-being of a population, including security against the effects of threatened terrorism, growing social isolation, and inequities in health. management in health can learn much from concepts of business management that have evolved to address the economic and human resource aspects of a health system at the macrolevel or an individual unit of service at the microlevel. the new public health is not contained within one organization, but rather reflects the collective efforts of national, state, regional, and local governments, many organizations in the public and non-governmental sectors, and finally efforts of individual or group advocates and providers and the public itself. the political level is crucial for adequate funding, legislation, and promotion of health-oriented policy positions and in public health management. the responsibility for health management is shared across all parts of society, including individuals, communities, business, and all levels of government. the new public health identifies and addresses community health risks and needs. planning is critical to the process of keeping a health system sustainable and adaptable and in creating adequate responses to new health threats. monitoring, measurement, and documentation of health needs are vital to design and adapt an effective program and to measure impact. data on the targeted issues must be accessible while protecting individual privacy. health is a hugely expensive and expansive complex of services, facilities, and programs provided by a wide range of professional and support service personnel making up one of the largest employers of any sector in a developed country. services are increasingly delivered by organized groups of providers. but all health systems operate in an environment of economic constraints, imposing a need to seek efficiency in the use of resources. how organizations function is of great importance not only for their economic survival, but also, and equally important, for the well-being of the clients and providers of care. an organization is two or more people working together to achieve a common goal. management is the process of defining the goals and making effective use of an organization to attain those goals. even very small units of a human organization require management. management of human resources is vital to the success of an organization, whether in a production or service industry. health systems may chapter vary from a single structure to a network of many organizations. no matter how organizations are financed or operated, they require management. management in health care has much to learn from approaches to management in other industries. elements of theories and practices of profit-oriented sector management can be applied to health services even if they are operated as non-profit enterprises. physicians, nurses, and other health professionals will very likely be involved in the management of some part of the health care system, whether a hospital department, a managed care system, a clinic, or even a small health care team. at every level, management always means working with people, using resources, providing services, and working towards common objectives. health providers require preparation in the theory and practice of management. a management orientation can help providers to understand the wider implications of clinical decisions and their role in helping the health care system to achieve goals and targets. students and practitioners of public health need preparation in order to recognize that a health care system is more complex than the direct provision of individual services. similarly, policy and management personnel need to be familiar with both individual and population health needs and related care issues. health has evolved from an individual one-on-one service to complex systems organized within financing arrangements, mostly under government auspices. as a governmental priority, health may be influenced by political ideology, sometimes reflecting societal attitudes of the party in power and sometimes apparently at odds with its general social policy. following bismarck's introduction in germany in of national health insurance for workers and their families, funded by both workers and their employers, most countries in the industrialized world introduced variants of this national health plan. usually, this has been at the initiative of socialist or liberal political leadership, but conservative political parties have preserved national health programs once implemented. despite the new conservatism since the s with its pre-eminent ideology of market forces, the growing roles for national, state, and local authorities in health have led to a predominantly government role in financing and overall responsibility for health care, even where there is no universal national health system, as in the usa. the uk's national health service (nhs), initiated by a labour government in , has survived through many changes of government, including the conservative margaret thatcher period in which many national industries and services were privatized. health policy is a function of national (government) responsibility overall for health, but implementation is formulated and met at state, local, or institutional levels. the division of responsibilities is not always clear cut but needs to be addressed and revised both professionally and politically within constitutional, legal, and financial constraints. selection of the direction to be taken in organizing health services is usually based on a mix of factors, including the political view of the government, public opinion, and rational assessment of needs as indicated through epidemiological data, cost-benefit analysis, the experience of "good public health practice" from leading countries, and recommendations by expert groups. lobbying on the part of professional or lay groups for particular interests they wish to promote is part of the process of policy formulation and has an important role in the planning and management of health care systems. there are always competing interests for limited resources of funding, by personnel within the health field itself and in competition with other demands outside the health sector. the political level is vitally involved in health management in establishing and maintaining national health systems, and in determining the place of health care as a percentage of total governmental budgetary expenditures, in allocating funds among the competing priorities. these competing priorities for government expenditures include defense, roads, education, and many others, as well as those within the health sector itself. traditionally, there are competing priorities between the hospital and medical sector and the public health and community programs sector. a political commitment to health must be accompanied by allocation of resources adequate to the scope of the task. thus, health policy is largely determined by societal priorities and is not a prerogative of government, health care providers, or any institution alone. as a result of long struggles by trade unions, advocacy groups, and political action, well-developed market economies have come to accept health as a national obligation and essential to an economically successful and well-ordered society. this realization has led to the implementation of universal access systems in most of the industrialized countries. once initiated, national health systems require high levels of resources, because the health system is labor intensive with relatively high salaries for health care professionals. in these countries, health expenditures consume between and nearly percent of gross domestic product (gdp). some industrialized countries, notably those in the former soviet bloc, lacking mechanisms for advocacy, including consumer and professional opinion, tended to view health with a political objective of social benefits, and also as a "non-productive" consumer of resources rather than a producer of new wealth. as a result, budget allocations and total expenditures for health as a percentage of gdp were well below those of other industrialized countries (figure . ). salaries for health personnel in the semashko system were low compared to industrial workers in the "productive" sectors. furthermore, industrial policy did not promote modern health-related industries, compared to the military or heavy industrial sectors. the former socialist countries of eastern europe which have joined the european union (eu) have gradually increased allocation to health from . percent of gdp in to . percent in , while the pre- members of the eu increased their expenditures from . percent of gdp to . percent. the average spend in the commonwealth of independent states (russia, ukraine, and others) increased from . percent in to . percent in , and in the central asian republics (kazakhstan, uzbekistan, and others) from . percent in to . percent in (who health for all database, january ). however, russian health expenditure in was still only . percent of gdp and there is a lingering idea of health being a non-productive investment. the developing countries generally spend under percent of gnp on health, because health is addressed as a relatively low political priority, and they depend very much on international donors for even the most basic of public health programs such as immunization. financing of health care and resource allocation requires a balance among primary, secondary, and tertiary care. economic assessment, monitoring, and evaluation are part of determining the health needs of the population. regulatory agencies are responsible for defining goals, priorities, and objectives for resulting services. targets and methods of achieving them provide the basis for implementation and evaluation strategies. planning requires written plans that include a statement of vision, mission objectives, target strategies, methods, and coordination during the implementation. designation and evaluation of responsibilities, resources to be committed, and participants and partners in the procedure are part of the continuous process of management. the dangers of taking a "wrong" direction may be severe, not only in terms of financial costs, but also in terms of high levels of preventable morbidity and mortality. health policy is often as imprecise a science as medicine itself. the difference is that inappropriate policy can affect the lives and well-being of very large numbers of people, as opposed to an individual being harmed by the mistake of one doctor. there may be no "correct" answer, and there are numerous controversies along the path. health policy remains more an "art" than the more quantitative and seemingly precise field of health economics. societal, economic, and cultural factors as well as personal habits have long been accepted as having an important impact on vulnerability to coronary heart disease. but other factors such as the degree of control over one's life, as suggested in studies of british civil servants, religiosity, and the effects of migration on families left behind are part of the social gradients and inequalities seen in many disease entities, with consequent excess morbidity and mortality in some contexts, such as in russia and ukraine. health policy, planning, and management are interrelated and interdependent. any set goal should be accompanied by planning how to attain it. a policy should state the values on which it is based, as well as specify sources of funding, planning, and management arrangements for its implementation. examination of the costs and benefits of alternative forms of health care helps in making decisions as to the structure and the content of health care services, both internal structures (within one organization) and external linkages (intersectoral cooperation with other organizations). the methods chosen to attain the goals become the applied health policy. the world health organization's (who's) health for all strategy was directed at the political level and intended to increase governmental awareness of health as a key component of overall development. to some degree it succeeded despite its expansive aspirations, and even after nearly years, its objectives remain worthwhile even in well-developed health systems. within health, primary care was stressed as the most effective investment to improve the health status of the population. in , the world bank's world development report adopted the health for all strategy and promoted the view that health is an important investment sector for general economic and social development. however, economic policies promoting privatization and deregulation in the health sector threaten to undermine this larger goal in countries with national health systems. in the usa, major steps are being taken to increase coverage of health insurance for all as the number of uninsured americans declined from million people uninsured in to . million in , edging down from . to . percent of the total population. further decline in the uninsured population is expected as the patient protection and affordable care act (ppaca, or "obamacare") comes into effect in the coming years, bringing many millions of americans into health insurance and meeting federal standards of fair practices such as eliminating exclusion for preexisting conditions by private insurers. the ppaca comes into effect on january and will guarantee coverage for pre-existing conditions, and ensure that premiums cannot vary based on gender or medical history. it will subsidize the cost of coverage, and new state-based health insurance exchanges will help consumers to find suitable policies. it will introduce many preventive care measures into public and private insurance plans, and will promote efficiencies in the health systems including reduction in fraudulent claims and wasteful funding systems. all of this will require skilled management in the components of the health system (see chapters and ). in the new public health, health promotion, preventive care, and clinical care are all part of public health because the well-being of the individual and the community requires a coordinated effort from all elements of the health spectrum. establishing and achieving national health goals require planning, management, and coordination at all levels. the achievement of health advances depends on organizations and structured efforts to reach health goals such as those defined above, and more recently by the united nations (un) in the millennium development goals (mdgs) (see chapter ), and requires some understanding of organizations and how they work. the study of organizations developed within sociology, but has gradually become a multidisciplinary activity involving many other professional fields, such as economics, anthropology, individual and group psychology, political science, human resources management, and engineering. organizations, whether in the public or private sector, exist within an external environment, and utilize their own structure, participants, and technology to achieve goals. for an organization to survive and thrive, it must adapt to the physical, social, cultural, and economic environment. organizations participating in health care establish the connection between service providers and consumers, with the goal of better health for the individual and the community. the factors for this include legislation, regulation, professionalism, instrumentation, medications, vaccines, education, and other modalities of intervention for prevention and treatment. the social structure of an organization may be formal (structured stability), natural (groupings reflecting common interests), or open (loosely coupled, interacting, and self-adjusting systems to achieve goals). formal systems are deliberately structured for the purposes of the organization. natural systems are less formal structures where participants work together collaboratively to achieve common goals defined by the organization. open systems relate elements of the organization to coalitions of partners in the external environment to achieve mutually desirable goals. in the health system, structures should focus on prevention and treatment of disease and improvement in health and well-being of society. the social structure of an organization includes values, norms, and roles governing the behavior of its participants. government, business, or service organizations, including health systems, require organizational structures, with a defined mission and set of values, in order to function. an organizational structure needs to be tailored to the size and complexity of the entity and the goals it wishes to achieve. the structure of an organization is the way in which it divides its labor into distinct tasks and coordinates them. the major organizational models, which are not mutually exclusive and may indeed be complementary, are the pyramidal (bureaucratic) and network structures. the bureaucratic model is based on a hierarchical chain of command with clearly defined roles. in contrast, the matrix or network organization brings together professional or technical people to work on specific programs, projects, or tasks. both are vital to most organizations to meet ongoing responsibilities and to address special challenges. some classic organization theory concepts help to set the base for modern management ideas as applied to the health sector. scientific management was pioneered by frederick winslow taylor . his work was pragmatic and based on empirical engineering, developed in observational studies carried out for the purpose of increasing worker, and therefore system, efficiency. taylor's industrial engineering studies of scientific management were based on the concept that the best way to improve worker productivity was by designing improved techniques or methods used by workers. this theory viewed workers as instruments to be manipulated by management, and assumed that efficient, rationally planned methods would produce better industrial results and industrial peace as the tasks of managers and workers would be better defined. time and motion studies analyzed work tasks to seek more efficient methods of work in factories. motivation of workers was seen to be related to payment by piecework and economic self-interest to maximize productivity. taylor sought to improve the productivity of each worker and to make management more efficient in order to increase earnings of employers and workers. he found that the worker was more efficient and productive if the worker was goal oriented rather than task oriented. this approach dominated organization theory during the early decades of the twentieth century. resistance to taylor's ideas came from both management and labor; the former because it seemed to interfere with managerial prerogatives and the latter because it expected the worker to function at top efficiency at all times. however, taylor's work had a lasting influence on the theory of work and organizations. the traditional pyramidal bureaucratic organization is classically seen in the military and civil services, but also in large-scale industry, where discipline, obedience, and loyalty to the organization are demanded, and individuality is minimized. this form of organization was analyzed by sociologist max weber between and . leadership is assigned by higher authority, and is presumed to have greater knowledge than members lower down in the organization. this form of organization is effective when the external and internal environments, the technology, and functions are relatively well defined, routine, and stable. the pyramidal system (figure . ) has an apex of policy and executive functions, a middle level of management personnel and support staff, and a base of the people who produce the output of the organization. the flow of information is generally one way, from the bottom to the top level, where decisions are made for the detailed performance of duties at all levels. lateralizing the information systems so that essential data can be shared to help staff at the middle and field or factory-floor levels of management is generally discouraged because this may promote decentralized rather than centralized management. even these types of organization have increasingly come to emphasize small-group loyalty, leadership initiative, and self-reliance. the bureaucratic organization has the following characteristics: l there is a fixed division of labor with a clear jurisdiction and based on assignments, which are subject to change by the leader. l there is a hierarchy of offices, with each lower functionary controlled and supervised by a higher one. employment is viewed as a tenured career for officials, after an initial trial period. the bureaucratic system, based on formal rationality, structure, and discipline, is widely used in production, service, and governmental agencies, including military and civilian departments and agencies. health systems, like other organizations, are dynamic and require continuous management, adjustment, and systems control. continuous monitoring and feedback, evaluation, and revision help to meet individual and community needs. the input-process-output model (figure . ) depends on feedback systems to make the administrative or educational changes needed to keep moving towards the selected objectives and targets. organizations use resources or inputs that are processed to achieve desired results or outputs. the resource inputs are money, personnel, information, and supplies. process is the accumulation of all activities taken to achieve the results intended. output, or outcome, is the product, its marketing, its reputation and quality, and profit. in a service sector such as health, output or impact can be measured in terms of reduced morbidity and/or mortality, improved health, or number of successfully treated and satisfied patients at affordable costs. the management system provides the resources and organizes the process by which it hopes to achieve the established goals. program implementation requires systematic feedback for the process to work effectively. when targets are set and strategy is defined, resources, whether new or existing, are placed at the service of the new program. management is then responsible for using the resources to achieve the intended targets. the results are the outcome or output measures, which are evaluated and fed back to the input and process levels. health systems consist of many subsystems, each with an organization, leaders, goals, targets, and internal information systems. subsystems need to communicate within themselves, with peer organizations, and with the macro (health) system. leadership style is central to this process. the surgeon as the leader of the team in the operating room depends on the support and judgment of other crucial people on the team, such as anesthesiologists, operating room nurses, pathologists, radiologists, and laboratory services, all of whom lead their own teams. hospital and public health directors cannot function without a high degree of decentralized responsibility and a creative team approach to quality development of the facility. health systems management includes analysis of service policy, budget, decision-making in policy, as well as operation, regulation, supervision, provision, maintenance, ethical standards, and legislation. policy formulation involves a set of decisions made in pursuit of a course of action for achieving selected health targets, such as those in the mdgs or continuing to update healthy people health targets in the usa (see chapter ). cybernetics, a term coined by norbert wiener, refers to systems or organizations which are dependent on each other to function, and whose interdependence requires flexibility of response. cybernetics gained wide credence in engineering in the early s, and feedback systems became part of standard practice of all modern management systems. its later transformations appeared in operating service systems, as information for management. application of this concept is entering the health sector. rapid advances in computer technology, by which personal computers have access to internet systems and large amounts of data, have already enhanced this process. in mechanistic systems, the behavior of each unit or part is constrained and limited; in organic systems, there is more interaction between parts of the system. the example used in figure . is the use of a thermostat to control the temperature and function of a heater according to conditions in the room. this is also described as a feedback system. cybernetics opens up new vistas on the use of health information for managing the operation of health systems. a database for each health district would allow assessment of current epidemiological patterns, with appropriate comparisons to neighboring districts or regional, state, and national patterns. data would need to be processed at state or national levels in comparable forms for a broad range of health status indicators. furthermore, the data should be prepared for online availability to local districts in the form of current health profiles. thus, data can be aggregated and disaggregated to meet the management needs of the service, and may be used to generate real targets and measure progress towards meeting them. a geographic information system may demonstrate high rates of a disease in a region due to local population risk factors, and thus become the basis for an intervention program. in the health field, the development of reporting systems based on specific diseases or categories has been handicapped by a lack of integrative systems and a geographic reporting approach. the technology of computers and the internet should be used to process data systems in real time and in a more user-friendly manner. this would enable local health authorities and providers to respond to actual health problems of the communities. health is a knowledge-based service industry, so that knowledge management and information technology are extremely important parts of the new public health, not only in patient care systems in hospitals, but also in public health delivery systems in the community, school, place of work, and home. mobilization of evidence and experience of best practices for policies and management decisionmaking is a fundamental responsibility of health leaders. the gap between information and action is wide and presents an ethical as well as a political challenge. regions with the most severe health problems lack trained personnel in assessment and exploitation of current state-of-the-art practices and technology in many practical public health fields, including immunization policy and in management of risk factors for stroke. knowledge and evidence are continuously evolving, but the capacity to access and interpret information is commonly poorly implemented in many countries so that very large numbers of people die of preventable diseases even when there are, overall, sufficient resources to address the challenges. international guidelines are vital to help countries to adopt current standards and make use of the available knowledge for public policy. political support and openness to international norms are crucial to this process of technology diffusion and building the physical and human resource infrastructure needed to achieve better population health with current best practices. development of health standards in low-income countries is progressing but is seriously handicapped by low levels of funding, lack of emphasis on training sufficient and appropriate human resource personnel and administrative support to promote measures which can save millions of lives. in high-income countries, the slow adoption of best international health standards can have harsh effects on population health, such as in the long delay in adopting national health insurance in the usa. in the european context, the eu has failed to adopt a harmonized recommended immunization program, which is badly needed for the new and potential members, as well as the older member countries. in countries of the former socialist bloc, mortality rates from stroke and coronary heart disease are slowly declining but remain two to four times higher than in countries of western europe (see chapter ). systems management requires access to and the use of knowledge to bridge these gaps. adoption and adaptation of knowledge to address local problems are essential in a globalized world, if only to prevent the international spread of threatened pandemics or adoption of unhealthy lifestyles (diet, smoking, and lack of exercise) to middle-income countries, which are developing a growing middle class alongside massive poverty. the application of knowledge and experience that has been successful in leading countries can foster innovation and create experience that may generate a local renewal process. management is crucial to address the complex "strategy areas for improving performance of health organizations: standards and guidelines, organizational design, education and training, improved process, technology and tool development, incentives, organizational culture, and leadership and management" (bradley et al., ) . managing a knowledge-based service industry or facility relies on leadership, collaboration to realize the potential of technology, professional skills, and social capital to the address the health problems faced by all countries. the management of resources to achieve productivity and measurable success has been characterized and accompanied by the development of systems of organizing people to create solutions to problems or to innovate towards defined objectives. operations research is a concept developed by british scientists and military personnel in search of solutions for specific problems of warfare during world wars i and ii. the approach was based on the development of multidisciplinary teams of scientists and personnel. the development of the anti-submarine detection investigation committee for underwater detection of submarines during world war i characterized and pioneered this form of research. the famous bletchley park enigma code-breaking success in britain and the manhattan project, in which the usa assembled a powerful research and development team which produced the atomic bomb, are prime world war ii examples. team-and goal-oriented work was very effective in problem solving under the enormous pressure of wartime needs. it also influenced postwar approaches to developmental needs in terms of applied science in such areas as the aerospace and computer industries. the computer hardware and software industries are characterized by innovation conceived and developed through informal working groups with a high level of individual competence, peer group dynamism, and commitment to problem solving. thus, the "nerds" of macintosh and microsoft beat the "suits" of ibm in innovation and introduction of the personal computer. similar startup groups, such as google and facebook, successfully took the internet to startling new levels of global applications, showing the capacity of innovation from california's silicon valley and its counterparts in other places in the usa and worldwide. in the health field, innovation in organization developed prepaid group practice which became the health maintenance organization (hmo), and later the managed care organization (mco), now a major, if controversial, factor in health care provision in the usa. other examples may be found in multidisciplinary research teams working on vaccines or pharmaceutical research, and in the increasingly multidisciplinary function of hospital departments and especially highly interdependent intensive care or home care teams. the business concept of management by objectives (mbo), pioneered in the s, has become a common theme in health management. mbo is a process whereby managers of an enterprise jointly identify its goals, define each individual's areas of responsibility in terms of the results expected, and use these measures as guides for operating the unit and assessing the contributions of its members. the common goals and then the individual unit goals must be established, as well as the organizational structure developed to help achieve these goals. the goals may be established in terms of outcome variables, such as defined targets for reduction of infant or maternal mortality rates. goals may also be set in terms of intervening or process variables, such as achieving percent immunization coverage, prenatal care attendance, or screening for breast cancer and mammography. achievements are measured in terms of relevancy, efficiency, impact, and effectiveness. the mbo approach has been subject to criticism in the field of business management because of its stress on mechanical application of quantitative outcome measures and because it ignores the issue of quality. this approach had great influence on the adoption of the objective of "health for all" by the who, and on the us department of health and human services' health targets for the year , later as healthy people , and now, based on these experiences and new evidence, renewed as healthy people . targeting diseases for eradication may contribute to institution building by developing experience and technical competence to broaden the organizational capacity. however, categorical programs or target-oriented programs can detract from the development of more comprehensive systems approaches. addressing the mdgs of reducing child and maternal mortality is at odds to some extent with targeting poliomyelitis for eradication and reliance on national immunization days, which distract planning and resource allocation for the buildup of the essential public health infrastructure for the basic immunization system so fundamental to child health. immunization and human immunodeficiency virus (hiv) control draw the major part of donor resources in developing countries, while education for strengthening human resources and infrastructure draw less donor attention. a balance between comprehensive and categorical approaches requires very skilled management. the mdgs agreed to by the un in as targets for the year provide a set of measurable objectives and a formula for international aid and for national development planning to help the poorest nations, with the wealthy nations providing aid, education, debt relief, and economic development through fairer trade practices. they are now being reviewed for extension to based on experience to date, with successes and failures, and recognizing the vital importance of non-communicable diseases as central to the health burden of low-and middleincome countries. management is the activity of coordinating and integrating organizational resources, including people, money, materials, time, and space. the purpose is to achieve defined/ stated objectives as effectively and efficiently as possible. whether in terms of producing goods and profits or in delivering services effectively, management deals with human motivation and behavior because workers are the key to achieving goals. knowledge and motivation of the individual client and the community are also essential for achieving good health. thus, management must take into account the knowledge, attitudes, beliefs, and practices of the consumer as much as or more than those of the people working within the system, as well as the general cultural and knowledge level in the society, as reflected in the media, political opinions, and organizations addressing the issues. management, like medicine, is both a science and an art. the application of scientific knowledge and technology in medicine involves both theory and practice. similarly, management practice involves elements of organizational theory, which, in turn, draws on the behavioral and social sciences and quantitative methodologies. sociology, psychology, anthropology, political science, history, and ethics contribute to the understanding of psychosocial systems, motivation, status, group dynamics, influence, power, authority, and leadership. quantitative methods including statistics, epidemiology, survey methods, and economic theory are also basic to development of systems concepts. comparative institutional analysis helps principles of organization and management to develop, while philosophy, ethics, and law are part of understanding individual and group value systems. organizational theory, a relatively new discipline in health, as an academic study of organizations, addresses health-related issues using the methods of economics, sociology, political science, anthropology, and psychology. the application of organizational theory in health care has evolved and become an integral part of training for, and the practice of, health administration. related practical disciplines include human resources, and industrial and organizational psychology. translation of organizational theory into management practice requires knowledge, planning, organization, mobilization of professional and other staff support for evidence-based best practices, assembly of resources, motivation, monitoring and control. health organizations have become more complex and costly over time, especially in their mix of specializations in science, technology, and professional services. organization and management are particularly crucial for successful application of the principles of the new public health, as it involves integration of traditionally separate health services. delegation of responsibilities in health systems, such as in intensive care units, is fundamental to success in patient care, with nurses taking increasing responsibility for the management of the severely ill patient suffering from multiple system failure. delegation or devolution of health care responsibilities to non-medical practitioners has been an ongoing development affecting nurse practitioners, physician assistants, paramedics, community health workers and others, as discussed in chapter . it is a vital process to provide needs not met by physicians because of shortages and inappropriate location or specialty preferences that leave primary care or other medical specialties unable to meet community and patient needs. elton mayo of the harvard school of business carried out a series of observational studies at the hawthorne, illinois, plant of the western electric company between and . mayo and his industrial engineer, along with psychologist colleagues, made a major contribution to the development of management theory. mayo began with industrial engineering studies of the effect of increased lighting on production at an assembly line. this was followed by other improvements in working conditions, including reduced length of the working day, longer rest periods, better illumination, color schemes, background music, and other factors in the physical environment. these studies showed that production increased with each of these changes and improvements. however, the researchers discovered, to their surprise, that production continued to increase when the improvements were withdrawn. furthermore, in a control group where conditions remained the same, productivity also grew during the study period. these results led mayo to conclude that the performance of workers improved because of a sense that management was interested in them, and that worker participation contributes to improved production. traditionally, industrial management viewed employees as mechanistic components of a production system. previous theory was that productivity was a function of working conditions and monetary incentives. what came to be known as the hawthorne effect showed the importance of social and psychological factors on productivity. formal and informal social organizations among management and employees were recognized as key elements in productivity, now called industrial humanism. research methods adapted from the behavioral sciences contributed to scientific studies in industrial management. traditional theories of the bureaucratic model of organization and management were modified by the behavioral sciences. this led to the emergence of the systems approach, or scientific analysis to analyze complex structures or organizations, taking into account the mutually interdependent elements of activities, interactions, and interpersonal relationships between management and workers. some revisits to the hawthorne studies suggest that the data do not support the conclusions, and offer a different interpretation. one is that informal groups such as workers on a production line themselves set standards for work which assert an informal social control outside the authority system of the organization. the informal cohesive group can thus control the norms of the amount of work acceptable to the group, i.e., not "too much" and not "too little". others point out that the effects were temporary and that there were extraneous factors, but the added value of the hawthorne effect remains part of the history of and had a culturechanging effect on management theory. the hawthorne effect in management is in some ways comparable to the placebo effect in clinical research and health care practice. it is also applied to clinical practice, whereby medical care provided by doctors is measured for specific "tracer conditions" to assess completeness of care according to current clinical guidelines. review of clinical records has been shown to be a factor in improving performance by doctors in practice, such as in treatment of acute myocardial infarction, management of hypertension, or completeness of carrying out preventive procedures such as screening for cancer of the cervix, breast, or colon (see chapters and ). awareness of being studied is a factor in improved performance or response to an intervention. studies of clinical practice-based research or public health interventions need to consider whether different types of studies and outcomes are more or less susceptible to the hawthorne effect (fernald et al., ). abraham maslow's hierarchy of human needs made an important contribution to management theory. maslow was an american psychologist, considered "the father of humanism" in psychology. maslow defined a prioritization of human needs (figure . ), starting with those of basic physical survival; at higher levels, human needs include social affiliation, self-esteem, and self-fulfillment. others in the hierarchy include socialization and self-realization; later revisions include cognitive needs. the survival needs of an employee include a base salary and benefits, including health insurance and pension; the safety and security needs include protection from injury, toxic exposure or excess stress; social needs at work include an identity, pride, friendships, union solidarity, company social activities and benefits; esteem and recognition include job titles, awards, and financial rewards for achievement by individuals, groups, or all employees; and self-actualization includes promotion to more challenging jobs with benefits, both financial and in terms of recognition. this concept is important in terms of management because it identifies human needs beyond those of physical and economic well-being. it relates them to the social context of the work environment with needs of recognition, satisfaction, self-esteem, and self-fulfillment. maslow's conclusions opened many positive areas of management research, not only in the motivation of workers in production and service industries, but also in the motivation of consumers. maslow's hierarchy of human needs contributed to the idea that workers' sense of well-being is important to management. his theories played an important role in application of sociological theory to client behavior, just as the topic of personal lifestyle in health became a central part of public health and clinical management of many conditions, such as in risk factor reduction for cardiovascular diseases. this concept fits well with the epidemiological studies referred to in the introduction, such as those showing strong relationships with sociopolitical factors as well as socioeconomic conditions. theory x-theory y (table . ), developed by clinical psychologist and professor of management douglas mcgregor in the s, examined two extremes in management assumptions about human nature that ultimately affect the operations of organizations. organizations with centralized decision-making, a hierarchical pyramid, and external control are based on certain concepts of human nature and motivation. mcgregor's theory, drawing on maslow's hierarchy of needs, describes an alternative set of assumptions that credit most people with the capacity for self-direction. traditional approaches to organization and management stress direction and external control. theory x assumes that workers are lazy, unambitious, uncreative, and motivated only by basic physiological needs or fear. theory y places stress on integration and self-control. this model provides a more optimistic leadership model, emphasizing management development programs and promoting human potential, assuming that, if properly motivated, people can be self-directed and creative at work, and that the role of management is to unleash this potential in workers with performance appraisal. many other theories of motivation and management have been developed to explain human behavior and how to utilize inherent skills to produce a more creative work environment, reduce resistance to change, reduce unnecessary disputes, and ultimately create a more effective organization. variants of the human motivation approach in management carried the concept further by examining industrial organization to determine the effects of management practices on individual behavior and personal growth within the work environment. they describe two contrasting models of workforce motivation. theory x assumes that management produces immature responses on the part of the worker: passivity, dependence, erratically shallow interests, shortterm perspective, subordination, and lack of self-awareness. in contrast, at the other end of the immaturity-maturity spectrum was the mature worker, with an active approach, an independent mind capable of a broad range of responses, deeper and stronger interests, a long-term perspective, and a high level of awareness and self-control. this model has been tested in a variety of industrial settings, showing that giving workers the opportunity to grow and mature on the job helps them to satisfy more than basic survival needs and allows them to use more of their potential in accomplishing organizational goals. this model became widely influential in human resource management theory of organizational behavior, organizational communication, and organizational development, and in the practical management of business and service enterprises. in the motivation to work ( ) , us clinical psychologist frederick herzberg wrote of his motivationhygiene theory. he developed this theory after extensive studies of engineers and accountants, examining what he called hygiene factors (i.e., administrative, supervisory, monetary, security, and status issues in work settings). his motivating factors included achievement, recognition of accomplishment, challenging work, and increased responsibility with personal and collective growth and development. he proved that the motivating factors had a substantial positive effect on job satisfaction. these human resource theories of management helped to change industrial approaches to motivation from "job enrichment" to a more fundamental and deliberate upgrading of responsibility, scope, and challenge of work, by letting workers develop their own ways of achieving objectives. even when the theories were applied to apparently unskilled workers, such as plant janitors, the workers changed from an apathetic, poorly performing group into a cohesive, productive team, taking pride in their work and appearance. this approach gave members of the team the opportunity to meet their human self-actualization needs by taking greater responsibility for problem solving, and it resulted in less absenteeism, higher morale, and greater productivity with improved quality. rensis likert, with mcdougal and herzberg, helped to pioneer the "human relations school" in the s, applying human resource theory to management systems and styles. likert classified his theory into four different systems, as follows. l system -management has no confidence or trust in subordinates, and avoids involving them in decisions and goal setting, which are made from the top down. management is task oriented, highly structured, and authoritarian. fear, punishment, threats, and occasional rewards are the principal methods of motivation. worker-management interaction is based on fear and mistrust. informal organizations within the system often develop that lead to passive resistance of management and are destructive to the goals of the formal organization. l system -management has a condescending relationship with subordinates, with some degree of trust and confidence. most decisions are centralized, but some decentralization is permitted. rewards and punishments are used for motivation. informal organizations become more important in the overall structure. l system -management places a greater degree of trust and confidence in subordinates, who are given a greater degree of decision-making powers. broad policy remains a centralized function. l system -management is seen as having complete confidence in subordinates. decision-making is dispersed, and communication flows upward, downward, and laterally. economic rewards are associated with achieving goals and improving methods. relationships between management and subordinates are frequent and friendly, with a sense of teamwork and a high degree of mutual respect. case studies showed that a shift in management from likert system towards system radically changed the performance of production, cut manufacturing costs, reduced staff turnover, and increased staff morale. furthermore, workers and managers both shared a concern for the quality of the product or service and the competitiveness and success of their business. the health industry includes highly trained professionals and paraprofessional workers who function as a team with a high degree of cohesion, mutual dependence, and autonomy, such as a surgical or an emergency department team. the network, or task-oriented working group, is basically a more democratic and participatory form of organization meant to elicit free interchange of concerns and ideas. this is a more organic form of organization, best suited to be effective for adaptation when the environment is complex and dynamic, when the workforce is largely professional, and when the technology and system functions change rapidly. complexities and technological change require information, expertise, flexibility, and innovation, strengths best promoted in free exchange of ideas in a mutually stimulating environment. in a network organization, leadership may be formal or informal, assigned to a particular function, which may be temporary, medium term, or permanent, to achieve a single defined task or develop an intersectoral program. the task force is usually for a short-term specific assignment; a working group, often for a medium-term project, such as integrating services of a region; and a committee for permanent tasks such as monitoring an immunization program. significant advantages of this form of organization are the challenge and the sharing of information and responsibility, which give professionals responsibility and job satisfaction by providing the opportunity to demonstrate their creativity. members of the task force may each report within their own pyramidal structure, but as a group they work to achieve the assigned objective. they may also be interdisciplinary or interagency working groups to review the state of the art in this particular issue as documented in reports and professional literature, and to coordinate activities, review previous work, or plan common future activities. an ongoing network organization may be a government cabinet committee to coordinate government policy and the work of various government departments, or a joint chiefs of staff to coordinate the various armed services. this approach is commonly used for task groups wherein interdisciplinary teams of professionals meet to coordinate functions of a department in a hospital, or where a multidisciplinary group of experts is established with the specified task of a technical nature. network organizational activity is part of the regular functions of a health professional. informal networking is a day-to-day activity of a physician in consultations with colleagues and also a part of more formalized network groups. the hospital department must, to a large extent, function as a network organization with different professionals working as a team more effectively than would be possible in a strictly authoritarian pyramidal model. a ministry of health may need to develop a joint working group with the ministry of transport, the police, and those responsible for standards of motor vehicles to seek ways to reduce road accident deaths and injuries. if a measles eradication project is envisioned, a multidisciplinary and multiorganizational team, or a network, should be established to plan and carry out the complex of tasks needed to achieve the target (figure . ) . in a public health context, a task group to determine how to reduce obesity rates in school-aged children, or to eradicate measles locally, might be chaired by the deputy chief medical officer or senior health promotion person; if the project is reduction of obesity among school children, the lead agency may be the department of education, perhaps jointly with the local department of health; if reduction in road traffic deaths is the topic, the lead may be the police department with participation of emergency transportation and hospital emergency room lead personnel. members may include the chief district nurse, an administrative and budget officer, a pharmacist, the chief of the pediatric department of the district hospital, a primary school administrator, a health educator, a medical association representative, the director of laboratories, the director of the supply department, a representative of the department of education, representatives of voluntary organizations interested in the topic, and others as appropriate. most organizational structures are mixed, combining elements of both the formal pyramidal and the less structured network structure with a task-oriented mandate. it is often difficult for a rigid pyramidal structure to deal with parallel bodies in a structured way, so the network approach is necessary to establish working relations with outside bodies to achieve common goals. a network is a democratic functional grouping of those professionals and organizations needed to achieve a defined target, sometimes involving people from many different organizations. the terms of reference of the working group are crucial to its function as well as its composition, time-frame, and access to relevant information. the application of this concept is increasingly central in health care organization as multilevel health systems evolve in the form of managed care or district health systems. these are vertically integrated management systems involving highly professional teams and units whose interdependence for patient care and financial responsibility are central elements of the new public health. in the usa during world war ii, w. edwards deming, a physicist and statistician, developed a system of economic and statistical methods of quality control in production industries. following the war, deming was invited to teach in japan and moved from the university to the level of industrial management. japanese industrialists adopted his principles of management and introduced quality management into all industries, with astonishingly successful results within a decade. the concept, later called total quality management (tqm), has since been adopted widely in production and service industries. in the deming approach to company management, quality is the top priority and is the key responsibility of management, not of the workers. if management sets the tone and involves the workers, quality goes up, costs come down, and both customer satisfaction and loyalty increase. having their ideas listened to, and avoiding a punitive inspection approach, enhances the pride of the workers. it is the responsibility of leadership to remove fear and build mutual participation and common interest. training is one of the most important investments of the organization. the differences between traditional management and the tqm approach are shown in boxes . and . . in societies with growing economies, the role of an educated workforce becomes greater as information technology and services, such as health, become larger parts of the economy and require professionalism and self-motivating workers. the tqm approach integrates the scientific management and human relations approaches by giving workers credit for intellectual capacity and expects them to use it to analyze and improve the tasks they perform. even more, this approach expects workers at all levels to contribute to better quality in the process of design, manufacture, and even marketing of the product or the service. the tqm ideas were revolutionary and successful when applied in business management in production industries. the tqm concept is much in discussion in the service industries. the who has adapted tqm to a model called continuous quality improvement (cqi), with the stress on mutual responsibilities throughout a health system for quality of care. the application of tqm and cqi approaches is discussed in chapter , including the external regulatory and self-development tqm approaches. in the health sector, issues such as prevention of health facility-acquired infections require staff dedicated to promoting a culture of cleaning, frequent and thorough hand washing, sterilization, isolation techniques, intravenous and intratracheal catheter and tube care technique, and immunization of hospital personnel. these and many other crossdisciplinary measures promote patient safety and prevent the costly and frequently deadly effects of serious respiratory or urinary tract injection acquired in hospitals or other health care facilities. human behavior is individual but takes place in a social context. changes to individual behavior are needed to reduce risk factors for many diseases. change can be threatening; it requires alteration, substitution, transformation, or modification of purposes, procedures, methods, or style. the implementation of plans usually requires some change, which often meets resistance. the resistance to change may be professional, technical, psychological, political, emotional, or a mix of all of these. the manager of a health facility or service has to cope with change and gather the support of those involved to participate in creating or implementing the change effectively. the behavior of the worker in a production or service industry is vital to the success of the organization. equally important is the behavior of the purchaser or consumer of the product or service. diagnosing organizational problems is an important skill to bring to leadership in health systems. even more important is the ability to identify and alter the variables that require change and adaptation to improve the performance of the organization. high expectations are essential to produce high performance and improved standards of service or productivity. conversely, low expectations not only lead to low performance, but produce a downward spiraling effect. this applies not only within the organization, but to the individuals and community served, l judgment, punishment, and reward for above-or belowaverage performance destroy teamwork essential for quality production. l work with suppliers to improve quality and costs. l profits are generated by loyal customers -running a company for profit alone is like driving a car by looking in the rearview mirror. whether in terms of purchase of goods produced or in terms of health-related behavior. people often resist change because of fear of the unknown. participation in the process of defining problems, formulating objectives, and identifying alternatives is needed to bring about changes. change in organizational performance is complex, and this is the test of leadership. similarly, change at the individual level is essential to achieve the goals of the group, whether this is in terms of the functioning of a health care service unit, such as a hospital, or whether it is an individual's decision to change from smoking to non-smoking status. the health of both an individual and a population depends on the individual health team member's motivation and experience. the behavior of the individual is important to his or her personal and community health. even small steps in the direction of a desirable change in behavior should be rewarded as soon as possible (i.e., reinforcing positive performance in increments). behavior modification is based on the concept that change of behavior starts with the feelings and attitudes within the individual, but can be influenced by knowledge, peer pressure, media coverage, and legislative standards. change involves a number of elements to define a current or previous starting point: change in behavior is vital in the health field: in the organization, in the community, in individual behavior, and in societal regulation and norms. the health belief model (chapter ) is widely influential in psychology and health promotion. the belief intervention approach involves programs meant to reduce risk factors for a public health problem. it may require change in the law and in organizational behavior, with involvement and feedback to the people who determine policy, those who manage services, and the community being served. obesity in school-aged children is being fought by many measures including healthier menus and banning the sale of high sugar drinks on school property. high cholesterol is being fought on many fronts including dietary change and banning the use of transfats in food processing. deaths from bulimia are not uncommon and may stem from teenage identification of beauty with ultrathin body image. banning television and modeling agencies from using models with a very low body mass index is an intervention in advertising which encourages harmful practices that are a danger to health and life. banning cigarette advertising and smoking in public places promotes behavioral change, as does raising the taxes on cigarettes. gun control laws are meant to prevent disturbed individuals or political fanatics having easy access to firearms to commit mass murder. strict enforcement of drinking and driving laws can prevent drunk driving and reduce road traffic deaths (see chapter ). in the s, major industries in the usa were unable to compete successfully with the japanese in the consumer electronics and automobile industries. management theory began to place greater emphasis on empowerment as a management tool. the tqm approach stresses teamwork and involvement of the worker in order to achieve better quality of production. comparatively, empowerment went further to involve the worker in operation, quality assessment, and even planning of the design and production process. results in production industries were remarkable, with increased efficiency, less absenteeism, and greater searching for ideas to improve quality and quantity of production, with the worker as a participant in the management and production process. the concept of empowerment entered the service industries with the same rationale. the rationale is that improvements in quality and effectiveness of service require the active physical and emotional participation of the worker. participation in decision-making is the key to empowerment. this requires management to adopt new methods that allow the worker, whether professional or manual, to be an active participant. successful application of the empowerment principles in health care extends to the patient, the family, and the community, emphasizing patients' rights to informed participation in decisions affecting their medical care, and the protection of privacy and dignity. diffusion of powers occurs when management of services is decentralized. delegation of powers to professional groups, non-governmental organizations (ngos), and advocacy organizations is part of empowerment in health care organizations. governmental powers to govern or promote areas such as licensure, accreditation, training, research, and service can be devolved to local authorities or ngos by delegation of authority or transfer of funds. organizational change may involve decentralization. institutional changes such as amalgamation of hospitals, long-term care facilities, home care programs, day surgery, ambulatory care, and public health services are needed to produce a more effective use of resources. integration of services under community leadership and management should encourage transfer of funds within a district health network from institutional care to community-based care. such changes are a test of leadership skills to achieve cultural change within an organization, which requires behavioral change and involvement of health workers in policy and management of the change process. strategic management emphasizes the importance of positioning the organization in its environment in relation to its mission, resources, consumers, and competitors. it requires development of a plan of action or implementation of a strategy to achieve the mission or goal of the organization within acceptable ethical and legal guidelines. articulation of these is a key role of the management level of an organization. defining the mission and goals of the organization must take into account the external and internal environment, resources, and operational needs to implement and evaluate the adequacy of the outcomes. the strategy of the organization matches its internal approach with external factors, such as consumer attitudes and competing organizations. strategy is a set of methods and skills of the health care manager to attain the objectives of a health organization, including: policy is the formulation of objectives and priorities. strategy refers to long-range plans to achieve stated objectives, indicating the problems to be expected and how to deal with them. strategy does not identify all actions to be taken, but it includes evaluation of progress made towards a stated goal. while the term has traditionally been used in a military context, it has become an essential concept in management, whether of industry, business, or health care. tactics are the methods used to fulfill the strategy. thus, strategic mbo is applicable to the health system, incorporating definitions of goals and targets, and the methods to achieve them (box . ). change in health organizations may involve a substantial alteration in the size or relationships between existing, well-established facilities and programs (table . ). a strategic plan for health reform in response to the need for cost containment, redefined health targets, or dissatisfaction with the status quo requires a model or a vision for the future and a well-managed program. opposition to change may occur for psychological, social, and economic reasons, or because of fear of loss of jobs or changes in assignments, salary, authority, benefits, or status. downsizing in the hospital sector, with buildup of community health services, is one of the major issues in health reforms in many countries. it can be accomplished over time by naturally occurring vacancies or attrition due to retirement, or by retraining and reassignment, all of which require skilled leadership. the introduction of new categories of health workers in hospitals such as phlebotomists, hospitalist doctors, and technicians of all kinds has improved hospital efficiency and safety. community health has benefited from home care and in many situations community health workers to assist and supervise patient care in remote rural villages and in urban centers, even in high-income countries, with health guides trained to help people to function with chronic illnesses and dementias (see chapter ). the new public health is an integration or coordination of many participating health care facilities and health-promoting programs. it is evolving in various forms in different places as networks with administrative and financial interaction between participating elements. each organization provides its own specific services or groups of services. how they function internally and how they interact functionally and financially are important aspects of the management and outcomes of health systems. the health system functions as a network with formal and informal relationships; it may be very broad and loosely connected as in a highly decentralized system, with many lines of communication, payment, regulation, standards setting, and levels of authority. the relationship and interchange between different health care providers have functional and economic elements. as an example, an educated adult woman is more likely than an uneducated woman to prepare herself for the requirements of pregnancy by smoking and alcohol or drug cessation, folic acid intake, healthful diet, and attending professional antenatal care. a pregnant woman who is healthy and prepared for pregnancy physically and emotionally, and who receives comprehensive prenatal care, is less likely than a woman whose health is neglected to develop complications and require prolonged hospital care as a result of childbirth. the cost of good prenatal care is a fraction of the economic cost of treating the potential complications and damage to her health or that of the newborn. a health system is responsible for ensuring that a woman of reproductive age takes folic acid tablets orally before becoming pregnant, has had access to family planning services so that the pregnancy is a desired one, ensures that the space between pregnancies is adequate for her health and that of her baby, and receives adequate prenatal care. an obstetrics department should be involved in assuring or providing the prenatal care, especially for high-risk cases, and delivery should be in hygienic and professionally supervised settings. similarly, for children and elderly people, there is a wide range of public health and personal care services that make up an adequate and cost-effective set of services and programs. the economic burden of caring for the sick child falls on the hospital. when there is a per capita grant to a district, the hospital and the primary care service have a mutual interest in reducing morbidity and hence mortality. this is the principle of the hmos and district health systems discussed elsewhere. it is also a fundamental principle of the new public health. health care organizations differ according to size, complexity, ownership, affiliations, types of services, and location. traditionally, a health care organization provides a single type of service, such as an acute care hospital providing episodic inpatient care, or a home health care agency. in present-day health reforms, health care organizations, such as an hmo or a district health system, provide a populationbased, comprehensive service program. each organization must have or develop a structure suited to meet its goals, in both the internal and external environments. the common elements that each organization must deal with include governance of policy, production or service, maintenance, financing, relating to the external environment, and adapting to changing conditions. a functional model of an organization perhaps best suited to the smaller hospital is the division of labor into specific functional departments; for example, medical, nursing, administration, pharmacy, maintenance, and dietary, each reporting through a single chain of command to the chief executive officer (ceo) (figure . ) . the governing agency, which may be a local non-profit board or a national health system, has overall legal responsibility for the operation and financial status of the hospital, as well as raising capital for improvements. the medical staff may be in private practice and work in the hospital with their own patients by application for this right as "attending physician", according to their professional qualifications, or the medical staff may be employed by the hospital in a similar way to the rest of the staff. salaried medical staff may include physicians in administration, pathology, anesthesia, and radiology, so that even in a private practice market system many medical staff members are hospital employees. increasingly, hospitals are employing "hospitalists", who are full-or part-time physicians whose work is in the health facility, to provide continuity of inpatient and emergency department services, augmenting the services of senior or attending staff or private practice physicians. this shift is in part related to the increasing numbers of female physicians who run their homes and families as well as practice medicine and who find this mode of work more attractive than full-time private practice. this model is the common arrangement in north american hospitals. the governing board of a "voluntary", nongovernmental, not-for-profit organization with municipal and community representatives may be appointed by a sponsoring religious, municipal, or fraternal organization. the corporate model in health care organization (figure . ) is often used in larger hospitals or where mergers with other hospitals or health facilities are taking place. the ceo delegates responsibility to other members of the senior management team who have operational responsibility for major sectors of the hospital's functioning. a variation of the corporate model is the divisional model of a health care organization based on the individual service divisions allowing middle management a high degree of autonomy (figure . ). there is often departmental budgeting for each service, which operates as an economic unit; that is, balancing income and expenditures. each division is responsible for its own performance, with powers of strategic and operational decision-making authority. this model is used widely in private corporations, and in many hospitals in the usa. with increasing complexity of services, it is also employed in corporate health systems in the usa, with regional divisions. the matrix model of a health care organization is based on a combination of pyramidal and network organization. this model is suited to a public health department in a state, county, or city. individual staff people report in the pyramidal chain of command, but also function in multidisciplinary teams to work on specific programs or projects. a nutritionist in the geriatric department is responsible to the chief of nutrition services but is functionally a member of the team on the geriatric unit. in a laterally integrated health maintenance organization or district health system, specialized staff may serve in both institutional (i.e., hospital) and community health roles (figure . ) . the organizational structure appropriate to one set of circumstances may not be suitable for all. whether the payment system is by norm (i.e., by predetermined numbers of staff, their salaries, and fixed costs for all services), per diem (i.e., payment of a daily rate times the number of days of stay), historical budget, or per capita in a regional or district health system structure (see chapters and ), the internal operation of a hospital will require a model of organization appropriate to it. hospitals need to modify their organizational structure as they evolve, and as the economics of health care change. leadership in an organization requires the ability to define the goals or mission of the organization and to develop a strategy and define steps needed to achieve these goals. it requires an ability to motivate and engender enthusiasm for this vision by working with others to gain their ideas, their support, and their participation in the effort. in health care as in other organizations, it is easier to formulate plans than to implement them. change requires the ability not only to formulate the concept of change, but also to modify the organizational structure, the budgeted resources, the operational policies and, perhaps most importantly, the corporate culture of the organization. management involves skills that are not automatically part of a health professional's training. skilled clinicians often move into positions requiring management skills in order to build and develop the health care infrastructure. in some countries, hospital managers must be physicians, often senior surgeons. clinical capability does not transfer automatically into management skills to deal with personnel, budgets, and resources. therefore, training in management is vital for the health professional. the manager needs training for investigations and factfinding as well as the ability to evaluate personnel, programs, and issues, and set priorities for dealing with the short-and long-term issues. negotiating with staff and outside agencies is a constant activity of the manager, ranging from the trivial to major decisions with wide implications. perhaps the most crucial skill of the manager is communication: the ability to convey verbal, written, or unwritten messages that are received and understood and to assess the responses as an equal part of the exchange. interpersonal skills are a part of management practice. the capable manager can relate to personnel at all levels in an open and equal manner. this skill is essential to help foster a sense of pride and involvement of all personnel in working towards the same goals and objectives, and to show that each member of the team is important to meeting the objectives of the organization. at the same time, the manager needs to communicate information, especially as to how the organization is doing in achieving its objectives. the manager is responsible for organizing, planning, controlling, directing, and motivating. managers assume multiple roles. a role is an organized set of behaviors. henry mintzberg described the roles needed by all managers: informational, interpersonal, and decisional roles. robert katz ( ) identified three managerial skills that are essential to successful management: technical, human, and conceptual: "technical skill involves process or technique knowledge and proficiency. managers use the processes, techniques and tools of a specific area. human skill involves the ability to interact effectively with people. managers interact and cooperate with employees. conceptual skill involves the formulation of ideas. managers understand abstract relationships, develop ideas, and solve problems creatively". technical skill deals with things, human skill concerns people, and conceptual skill has to do with ideas. the distribution of these skills between the levels of management is shown in figure . . hospital directors in the past were often senior physicians, often called superintendents, without training in health management. the business manager ceo has become common in hospital management in the usa. during the s, the ceo was called an administrator, and worked under the direction of a board of trustees who raised funds, set policies, and were often involved in internal administration. where the ceo was a non-physician, the usual case in north american hospitals, a conflict often existed with the clinical staff of the hospital. in some settings, this led to appointment of a parallel structure with a full-time chief of medical staff with a focus on clinical and qualitative matters. in european hospitals, the ceo is usually a physician, often by law, and the integration of the management function with the role of clinical chief is the prevalent model. over time, as the cost and complexity of the health system have increased, the ceo role has changed to one of a "coordinator". the ceo is now more involved in external relations and less in the day-to-day operation of the facility. the ceo is a leader/partner but primus inter pares, or first among equals, in a management team that shares information and works to define objectives and solve problems. this de-emphasizes the authoritarian role and stresses the integrative function. the ceo is responsible for the financial management of operational and capital budgets of the facility, which is integral to the planning and future development of the facility. budgets include four main factors: income, fixed or regular overhead, variable or unpredictable overhead, and capital or development costs, all essential to the survival and development of the organization. the key role of top management is to develop a vision, goals, and targets for the institution, to maintain an atmosphere and systems to promote the quality of care, financial solidity, and to represent the institution to the public. the overall responsibility for the function and well-being of the program is with the ceo and the governing board of directors. community participation in management of health facilities has a long-standing and constructive tradition. the traditional hospital board has served as a mechanism for community participation and leadership in promoting health facility development and management at the community level. the role of hospital boards evolved from primarily a philanthropic and fund-raising one to a greater overall responsibility for policy and planning function working closely with management and senior professional staff. this change occurred as operational costs increased rapidly, as government insurance schemes were implemented, and as court decisions defined the liability of hospitals and reinforced the broadened role of governing boards in malpractice cases and quality assurance. centrally developed health systems such as the uk's nhs have promoted district and county health systems with high degrees of community participation and management, both at the district level and for services or facilities. the role of local authorities, as well as state and national governments, is crucial to the functioning of public health in its traditional issues such as safe water supply, sanitation, business licensing, social welfare, and many others, as discussed in chapter . these functions have not diminished with the greater roles of state and federal or national governments in health. in healthful living environments the local authority functions are of continuing and indeed expanding importance, as in urban planning and transportation, promoting easy access to commercial facilities for shopping and healthy food sources for poorer sections as well as those available to prosperous members of the community. advocacy has always been an important part of public health. an illustration of this is seen in box . in changing the law banning birth control in massachusetts in the s. the issue of birth control still casts a heavy burden on women globally owing to religious objections, so this example from the s is still relevant as a political issue both in the usa and in many other countries. community participation can be crucial to the success of an intervention to promote community health. sensitivity to local, religious, or ethnic concerns is part of planning any study or intervention in public health. this does not mean that the national, state, and local health authorities must continuously canvass public opinion, but there is advantage in holding referenda on some issues compared to governmental fiat. the usa has higher rates of fluoridation than most countries, and this is implemented after referenda in each municipality (see chapter ). in portland, oregon, the city council profluoridation vote in (new york times, september ) was later rejected in the public referendum. portland is the only major american city without fluoridation (portland tribune, may ). rationalization of health facilities increasingly means organizational linkages between previously independent facilities. mergers of health facilities are common events in many health systems. in the usa, there are frequent mergers between hospitals, or between facilities linked to hmos or managed care systems. health reform in many countries is based on similar linkages. governmental approval and alteration to financing systems are needed to promote linkages between services to achieve greater efficiency and improve patient care (see chapters and ). lateral integration is the term used for amalgamation among similar facilities. like a chain of hotels, in health care this involves two or more hospitals, usually meant to achieve cost savings, improve financing and efficiency, and reduce duplication of services. urban hospitals, both notfor-profit as well as for-profit, often respond to competition by purchasing or amalgamating with other hospitals to increase market share in competitive environments. this is often easier for hospital-oriented ceos and staff to comprehend and manage, but it avoids the issues of downsizing and integration with community-based services. vertical integration describes organizational linkages between different kinds of health care facilities to form integrated, comprehensive health service networks. this permits a shift of emphasis and resources from inpatient care to long-term, home, and ambulatory care, and is known as the managed care or district health system model. community interest is a factor in promoting change to integrate services, which can be a major change for the management culture, especially of the hospital. the survival of a health care facility may depend on integration with appropriate changes in concepts of management. in the s, a large majority of california residents moved to managed care programs because of the high cost of fee-for-service indemnity health insurance and because of federal waivers to promote managed care for medicare and medicaid beneficiaries. independent community hospitals without a strong connection to managed care organizations (mcos) were in danger of losing their financial base. hospital bed supplies were reduced in the usa however, the article served to stimulate the legislature to revisit the law, leading to its repeal in , thus allowing use of all methods of birth control. the controversy subsided and women were free to control their own fertility as a result of this advocacy. by diagnosis-related group (drg), rather than on a per diem basis. similar trends are seen in european countries, although in the commonwealth of independent states the number of hospital beds declined between and - but stabilized at high and inefficient levels ( beds per population) compared to the number in western europe, which fell from beds per in to . in , and in some countries to per population despite increased longevity and aging of the population. there was a shift to stronger ambulatory care, as occurred throughout the industrialized countries despite an aging of the population. these trends were largely due to greater emphasis on ambulatory surgery and other care, and major medical centers responded with strategic plans to purchase community hospitals and develop affiliated medical groups and contract relationships with managed care organizations to strengthen their "market share" service population base for the future. the new payment environment and managed care also promoted hospital mergers (lateral integration) and linkages between different levels of service, such as teaching hospitals with community hospitals and primary community care services (vertical integration). vertical integration not only is important in urban areas, but can serve as a basis for developing rural health care in both developed and developing countries. the district hospital and primary care center operating as an integrated program can provide a high-quality program. hospitalcentered health care, common in industrialized countries, has traditionally channeled a high percentage of total health expenditures into hospital services. over recent years, there has been a reduction in hospital bed supply in most industrialized countries, with shorter length of stay, more emphasis on ambulatory care, improved diagnostic facilities, and improved outcomes of care (see chapter ). expenditures on the hospital component of care have come down to between and percent of total health expenditures in many countries, with a growing proportion going to ambulatory and primary care, and increased percentages to public health. this shift in priorities has been an evolutionary process that will continue, but requires skilled management leadership, grounded in health systems management training and epidemiological knowledge, and skilled negotiating skills to foster primary care and health promotion approaches both within the organization and in relation to outside services, especially preventive services. this shift in policy direction will be fostered in implementation of the ppaca (obamacare), discussed in chapters and . managed care systems or accountable care organizations (acos) will integrate hospital and community care and try to limit hospital care by strengthening ambulatory and primary care, and especially preventive care. this will have both economic and epidemiological benefits, but will depend on skilled management to understand and lead in their implementation. much of the rationale for these changes is discussed in the literature and summarized in a report from the us institute of medicine, entitled "best care at lower cost". this report calls for overhauling the health system in a continuous evolution based on evidence and lessons learned from decades of innovative care systems and research into their workings. the health system needs to relate to other community services with a shared population orientation (institute of medicine, ). norms are useful to promote efficient use of resources and promote high standards of care, if based on empirical standards proved by experience, trial and error, and scientific observation. norms may be needed even without adequate evidence, but should be tested in the reality of observation, experience, and experiment. this process requires data for selected health indicators and trained observers free to examine, report, and publish their findings for open discussion among colleagues and peers in proceedings open to the media and the general public. normative standards of planning are the determination of a number per unit of population that is deemed to be suitable for population needs; for example, the number of beds or doctors per population or length of stay in hospital. many organizations based on the bureaucratic model used norms as the basis for planning and allocation of resources including funding (see chapter ). this led to payment systems which encouraged greater use of that resource. if a factory is paid by the number of workers and not the number and quality of the cars produced, then management will have no incentive to introduce efficiency or quality improvement measures. if a district or a hospital is paid by the number of beds, or by days of care in the hospital, there is no incentive to introduce alternative services such as same-day or outpatient surgery and home care. performance indicators are measures of completion of specific functions of preventive care such as immunization, mammography, pap smears, and diabetes and hypertension screening. they are indirect measures of economy, efficiency, and effectiveness of a service and are being adopted as better methods of monitoring and paying for a service, such as by paying a premium. general practitioners in the uk receive additional payments for full immunization coverage of the children registered in their practices. a block grant or per capita sum may be tied to indicators that reflect good standards of care or prevention, such as low infant, child, and maternal mortality. incentive payments to hospitals can promote ambulatory services as alternatives to admissions and reduce lengths of stay. limitations of financial resources in the industrialized countries and even more so in the developing countries make the use of appropriate performance indicators of great importance in the management of resources. pay-for-performance is a system of paying for health services developed in the uk for paying general practitioners, with apparently satisfactory results. it is now widely used in the usa. it is defined as "a strategy to improve health care delivery that relies on the use of market or purchaser power. agency for healthcare research and quality (ahrq) resources on pay for performance (p p), depending on the context, refers to financial incentives that reward providers for the achievement of a range of payer objectives, including delivery efficiencies, submission of data and measures to payer, and improved quality and patient safety" (agency for healthcare research and quality, ) . more than half of commercial hmos are using pay-for-performance. recent legislation requires the medicare and medicaid programs to adopt this approach for beneficiaries and providers. as commercial programs have evolved during the past years, the categories of providers (clinicians, hospitals, and other health care facilities), number of measures, and dollar amounts at risk have increased. this method of payment is likely to be promoted in the affordable care act implementation to improve quality and control cost increases in us health care (see chapters , , and ). payfor-performance has also been adopted in other countries trying to improve quality of care, such as macedonia (lazarevik and kasapinov, ) . social marketing is the systematic application of marketing alongside other concepts and techniques to achieve specific behavioral goals for a social good. initially focused on commercial goals in the s, the concept became part of health promotion activities to address health issues where there was no current biomedical approach, such as in smoking reduction and in safe sex practices to prevent the spread of hiv. social marketing was based initially on commercial marketing techniques but now integrates a full range of social sciences and social policy approaches using the strong customer understanding and insight approach to inform and guide effective policy and strategy development. it has become part of public health practice and policy setting to achieve both strategic and operational targets. a classic example of the success is seen with tobacco reduction strategies in many countries using education, taxation, and legislative restrictions. other challenges in this field include risk behavior such as alcohol abuse through binge drinking, unsafe sex practices, and dietary practices harmful to health. philanthropy and volunteerism have long been important elements of health systems through building hospitals, mission houses, and food provision, and other prototype initiatives on a demonstration basis. this approach has been instrumental in such areas as improved care and prevention of hiv, immunization in underdeveloped countries, global health strategies, and maternal and child health services. during the late twentieth and early twenty-first centuries, a new "social entrepreneurship" was initiated and developed by prominent reform-minded former us president bill clinton, microsoft's bill gates, and the open society institute of george soros. the rotary club international has been a major factor in funding and promoting the global campaign to eradicate poliomyelitis. this has promoted integration and consortia for the promotion of acquired immunodeficiency syndrome (aids) prevention and malaria control in many developing countries. the global alliance for vaccine and immunization (gavi) is a us-based organization which links international public and private organizations and resources to extend access to immunization globally. it includes the united nations children's fund (unicef), who, bilateral donor countries, the vaccine industry, the gates foundation, and other major donors. gavi has made an important contribution to advancing vaccine coverage and adding important new vaccines in many developing countries and regions. these organizations focus funds and activities on promoting improved care and prevention of hiv, tuberculosis, and malaria, along with improved vaccination for children, reproductive health, global health strategies, technologies, and advocacy. these programs generate publicity and raise consciousness at political levels where resource allocations are made. a central feature of these programs is the promotion of "civil society" as active partners in a globalized world of free trade, democracy, and peace. specific initiatives included promoting improved largescale marketing of antiretroviral drugs for the treatment of hiv infection, including price reduction so that developing countries can offer antiretroviral treatment, especially to reduce mother-to-infant transmission. programs have branched out into the distribution of malaria-preventing bed nets, provision of low-cost pharmaceuticals, marketing drugs for the poor, desalination plants, solar roof units, lowcost small loans, and cell phones, mainly in africa. another form of social entrepreneurship that has gained support in the private sector is proactiveness in environmental consciousness to address issues raised by the environmental movement, and public interest for environmental accountability. the automobile industry is facing both public concern and federal legal mandates for improved gas mileage as opposed to public demand for larger cars. hybrid cars using less fuel have been successfully introduced into the market for low-emission, fuel-efficient cars, and electric cars are gradually entering the field. public opinion is showing signs of moving towards promoting environmentally friendly design, marketing, and purchasing practices in energy consumption, conservation practices, and public policy. public opinion and the price of fuel will play a major part in driving governments to legislate energy and conservation policies to address global warming and damage to the environment, with their many negative health consequences. however, such changes must work with public opinion because of the sensitivity of consumers to the price of fuel. in addition, when food crops, such as corn, are used to produce ethanol for energy to replace oil, then food prices rise and consumers suffer and respond vigorously. corporations adopt policies of environmental responsibility in part because of public relations and partly because of potential liability claims. much of the planning and financial costs of offshore petroleum and gas drilling is spent on safety measures to protect the environment. the explosion in at a british petroleum site in the gulf of mexico, off the coast of texas and louisiana, caused massive pollution and environmental damage, and resulted in the us government being awarded us$ . billion against bp for cleanup and damages. the reputation of the corporation suffered and some executive officers lost their positions. thus, corporate social responsibility can be seen as self-interest. new models of health care organization are emerging and developing rapidly in many countries. this is partly a result of a search for more economical methods of delivering health care and partly the result of the target-oriented approach to health planning that seeks the best way to define and achieve health objectives. the developed countries seek ways to restrain cost increases, and the developing countries seek effective ways to quickly and inexpensively raise health standards for their populations. new organizational models that try to meet these objectives include district health systems, managed care organizations (mcos) and accountable care organizations (acos), described in greater detail in chapter . critical and basic elements of a health system organization are shown in figure . . new initiatives are part of the growth and development of any organization or health service system, as needs, technologies, resources, and public demand change. identification of issues and decisions to launch new endeavors or projects to advance the state of the art, to address unmet needs, or to meet competition are part of organizational responsibility, in the public sector to meet needs, and in the private sector to remain competitive. in developing and developed countries, many ngos provide funding from abroad for essential services that a government may be unable to provide. such projects focus on issues directed from the head offices in the usa or europe of the funding source or management offices for specific vertical programs which are often not fully integrated with national priorities and programs. however, these need coordination and approval by the local national government agency responsible for that sector of public service. new projects run by ngos may run in parallel to each other, or to state health services as uncoordinated activities. governmental public health agencies have responsibility for oversight of health systems and can play a leadership and regulatory role in coordinating activities and directing new programs to areas of greatest national need. the public health agency may also seek funding to launch new pilot or specific needs programs. the agency may introduce a new vaccine into a routine immunization program in phases, pending government approval and funding to incorporate it as a routine immunization program based on evaluation of the initial phase. an example is the introduction of haemophilus influenzae type b vaccine in albania in , which was funded by gavi for years based on a study and proposal including a cost-effectiveness study (bino s, ginsberg g, personal communication, ) . proposals for health projects by ngos or private agencies need to be prepared in keeping with the vision, mission, and objectives of the responsible governmental agency, with ethics review and community participation. a project proposal should include why the project is important, its specific goals and objectives, available or new resources, and the time-frame required to achieve success (box . ). it should describe the means proposed to accomplish the goals, and how the proposed program will impact the community, providing recommendations for follow-up and/or further action. the introduction of the project proposal outlines the current state of the problem and the case for action. it should describe existing programs which address that issue, with proposed collaboration, and expansion or improvement of programs, but avoiding duplication of services. background information needs to relate the project to the priorities of the prospective funding organization. the objectives should follow the acronym "smart": specific, measurable, achievable, relevant, and time-based. this term, originally used for computer disc self-management, has been adapted as a current form of mbo from the s and s. the project objectives should be feasible and the expected results of the project should be based on the stated objectives. organizations: behavior, structure, process. new york: mcgraw-hill/ irwin; . the proposed funding agency expects convincing evidence of how this program will be effective, efficient, practical, and realistic. this information is presented in the activities section, which also needs to address the resources that will be needed to implement the program such as the budget for staff, supervison, training, management, materials (vaccines, syringes, equipment, ongoing supplies and others), transportation, and costs of premises. after completing the activities section, a realistic and achievable work plan and time-frame are required. well-planned projects have monitoring and evaluation criteria. monitoring follows the performance of the program, documenting successes, failures, and lessons learned, as well as expenditures. evaluation guidelines of the program define the methods used to assess the impact of the project and whether the project was carried out in an effective and efficient manner, and may be required periodically throughout the life of the project. the most difficult issue is sustainability. a project funded by an ngo is usually time limited to - years and the survival of the program usually depends on its acceptability and the capacity of government to continue it. thus, evaluation becomes even more crucial for the follow-up of even successful short-term projects. harm reduction programs include tackling hiv in drug users, reducing maternal-child hiv transmission, tobacco control programs, and reducing levels of obesity in schoolchildren. sustainability and diffusion of positive findings to wider application are important challenges, especially to global health. even in high-income countries, diffusion of best practices is often slow and fraught with controversy and inertia. examples of this slow or non-diffusion of evidence-based public health include the failure of most european countries to harmonize salt fortification with iodine or total indifference to flour fortification with folic acid to prevent neural tube defects (see chapters and ). public health work within departments or ministries of health or local health authorities operates at a disadvantage in comparison with other health activities, especially hospitals, pharmaceuticals, diagnostics, and medical care. the competition for resources in a centrally funded system is intense, and the political and bureaucratic battles for funds may pit new immunization agents or health promotion programs against new cancer treatment drugs or scanners, and this is very often a difficult struggle. the presentation of program proposals for new public health interventions requires skill, professionalism, good timing, and the help of informed public and professional opinion. allocation of resources is decided at the political level in a tax-based universal system, while even in a social security (bismarckian) system where funding is through an employee-employer payroll deduction, additional funding from government is essential to keep up with the continuing flow of new modalities of treatment or prevention. public health is handicapped in portraying the costs and benefits of important interventions, leaving new programs with insufficient resources, including the staffing and administrative costs (e.g., office space, phone service, transportation costs), which are essential parts of any public health program. portraying the cost of the new proposed program should be based on the total population served, not just the specific target population for a new program; that is, it should be represented as a per capita cost. similarly, projected benefits should extrapolate the results from other areas, such as pandemic or avian flu or severe acute respiratory syndrome (sars), and the likely impact on the target geographic area and its population. public health has prime responsibility for monitoring the health status of the population as well as in preventing infectious and non-communicable diseases and injuries, preparing for disasters, and many other functions. this role requires an adequate multidisciplinary workforce with high levels of competencies. this topic is discussed extensively in chapter . canada's experience with the sars epidemic in led to a reappraisal of public health preparedness and standards. this, in turn, led to the establishment of the national public health agency of canada, which is mandated to develop standards and practices to raise the quality of public health in the country and especially to prepare for possible pandemics. the agency issued standards of competency for public health personnel and fostered the development of regional laboratories, and schools of public health were developed across canada. core competencies for program planning implementation and evaluation are seen in box . . health care systems throughout the world are being scrutinized because of their growing costs in relation to national wealth. at the same time, techniques for evaluating health care with respect to appropriateness, quality, and resource allocation are being developed. these techniques are multifactorial since they must relate to all aspects of health care, including the characteristics of the population being served; available health care resources; measures of the process and utilization of care; measures of health care outcomes; peer review, including quality assessment of health care providers; consumer attitudes, knowledge, and compliance; care provided for "tracer" or sample conditions; and economic cost-benefit studies. evaluation in health care assumes that a health care system and the providers of health care within that system are responsible and accountable for the health status of the population. it must, however, recognize that health services are not the sole determinants of health status; social, economic, and cultural factors also play key roles. a comprehensive approach to evaluation in health care is described in chapter . many of the components that are available in health care systems exist, while others that remain to be developed are discussed. evaluation is an integral part of a comprehensive health care system, in that the components of evaluation must be built into any national system. as long as rationality is expected of health care, evaluation is an essential element of the overall system (tulchinsky, ) (see chapter ). the purpose of management in health is the improvement of health, and not merely the maintenance of an institution. separate management of a variety of health facilities serving a community has derived from different historical development and funding systems. in competition for public attention and political support, public health suffers in comparison to hospitals, new technology and drugs, and other competitors for limited resources. the experience of successes in reducing mortality from both non-infectious and infectious conditions comes largely from public health interventions. medical care is also an essential part of public health, so that management and resource allocation within the total health sector are interactive and mutually dependent. the new public health looks at all services as part of a network of interdependent services, each contributing to health needs, whether in hospital care or in enforcing public health law regarding; for example, motor vehicle safety and smoking restriction in public places. separate management and budgeting of a complex of services results in disproportionate funds, staff, and attention being directed towards high-cost services such as hospitals, and fails to redirect resources to more cost-effective and patient-sensitive kinds of services, such as home and preventive care. however, reducing the supply of hospital beds and implementing payment systems with resources for early diagnosis and incentives for short stays have changed this situation quite dramatically in recent decades. the effects of incentives and disincentives built into funding systems are central issues in determining how management approaches problem solving and program planning, and are therefore important considerations in promoting health. the management approach to resolving this dilemma is professional vision and leadership to promote the broader new public health. thus, managers of hospitals and other health facilities need broad-based training in a new public health in order to understand the interrelationships of services, funding, and population health. managers who continue to work with an obsolescent paradigm with the traditional emphasis, regardless of the larger picture, may find the hospital non-competitive in a new climate where economic incentives promote downsizing institutions and upgrading health promotion. defensive, internalized management will become obsolete, while forward-looking management will be the pioneers of the new public health. this may be seen as a systems approach to improve population and individual health, based on strategic planning for immediate needs and adaptation of health systems in the longer term issues in health. examples of national planning that cut across health and social services include national insurance policies and the provision of new services to meet rising needs, as shown for alzheimer's disease, in france since (box . ) and in the usa since (box . ). health care is one of the largest and most important industries in any country, consuming anywhere from to nearly percent of gnp, and still growing. it is a service, not a production industry, and is vital to the health and well-being box . core competencies for program planning, implementation and evaluation management, from policy to operational management of a production or a service system. creative management of health systems is vital to the functioning of the system at the macrolevel, as well as in the individual department or service. this implies effective use of resources to achieve objectives, and community, provider, and consumer satisfaction. these are formidable challenges, not only when money is available in abundance, but even more so when resources are limited and difficult choices need to be made. modern management includes knowledge and skills in identifying and measuring community health needs and health risks. critical needs are addressed in strategic planning with measurable impacts and targets. public health managers should have skills gained in marketing, networking, data management, managing human resources and finance, engaging community partners, and communicating public health messages. many of the methods of management and organization theory developed as part of the business world have become part of public health. these include defining the mission, values and objectives of the organization, strategic planning and management, mbo, human resource management (recognizing individual and professional values), incentives-disincentives, regulation, education, and economic resources. the ultimate mission of public health is the saving of human life and improving its quality, and achieving this efficiently with high standards of professionalism and community involvement. the scope of the new public health is broad. it includes the traditional public health programs, but equally must concern itself with managing and planning comprehensive service systems and measuring their function. the selection of targets and priorities is often determined by the feasible rather than the ideal. the health manager, either at the macrolevel of health or managing a local clinic, needs to be able to conceptualize the possibilities of improving the health of individuals and the population in his or her service responsibility with current and appropriate methods. good management means designing objectives based on a balance between the feasible and the desirable. public health has benefited greatly from its work with the social sciences and assistance from management and systems sciences to adapt and absorb the new challenges and technologies in applied public health. the new public health is not only a concept; it is a management approach to improve the health of individuals and the population. for a complete bibliography and guidance for student reviews and expected competencies please see companion web site at http://booksite.elsevier.com/ bibliography electronic resources glossary of managed care terms national association of public hospitals and health systems world health organization, the health manager's website pay for performance (p p): ahrq resources dr. deming: the american who taught the japanese about quality achieving a high performance health care system with universal access: what the united states can learn from other countries improving the effectiveness of health care and public health: a multi-scale complex systems analysis framework for program evaluation in public health biological and chemical terrorism: strategic plan for preparedness and response. recommendations of the cdc strategic planning workgroup a framework for program evaluation. office of the associate director for program -program evaluation developing leadership skills patterns of ambulatory health care in five different delivery systems capacity planning in health care: a review of the international experience. who, on behalf of the european observatory on health systems and policies strategic management of health care organizations social media engagement and public health communication: implications for public health organizations being truly "social crossing the quality chasm: a new health system for the twenty-first century future of the public's health in the st century best care at lower cost: the path to continuously learning health care in america behavioral interventions to reduce risk for sexual transmission of hiv among men who have sex with men cd . available at the wisdom of teams: creating the high-performance organization social marketing: influencing behaviors for good the interaction of public health and primary care: functional roles and organizational models that bridge individual and population perspectives the powers and pitfalls of the payment for performance three skills every st-century manager needs total quality management as competitive advantage: a review and empirical study making the best of hospital pay for performance the public health approach to eliminating disparities in health public health systems and services research: building the evidence base to improve public health practice united states innovations in healthcare delivery a call to action: lowering the cost of health care reduced mortality with hospital pay for performance in england practical challenges of systems thinking and modeling in public health public health: essentials of public health health united states the funding organization will want to know what will be the expected product of the program in measurable process (e.g., immunization coverage) or outcome indicators (e.g., reduced child mortality). projections will be based on the intended activities and known outcomes of other past programs with similar goals in the same or other countries (environmental scan), and should be supported by a review of local and international literature on the topic. the activities section of a proposal should include a timeline of the intended actions and a description of activities based on best practices. the expected outcomes, monitoring and evaluation, and justification are all part of the presentation (box . ). the following utility standards ensure that an evaluation will serve the information needs of intended users: l identify and engage stakeholders, including relevant government agencies, people or communities involved in or affected by the evaluation, so that their needs and concerns can be addressed. l develop and describe the program. l focus the evaluation design with ethical standards and review requirements respected.l gather credible evidence -the people conducting the evaluation should be trustworthy and competent in performing the evaluation for findings to achieve maximum credibility and acceptance. information collected should address pertinent questions regarding the program and be responsive to the needs and interests of clients and other specified stakeholders.l justify the conclusions -the perspectives, procedures, and rationale used to interpret the findings should be carefully described so that the bases for value judgments are clear. l ensure sharing and use of information and lessons learned -evaluation reports should clearly describe the program being evaluated, including its context and the purposes, procedures, and findings of the evaluation so that essential information is provided and easily understood. substantial interim findings and evaluation reports should be disseminated to intended users so that they can be used in a timely fashion to encourage follow-through by stakeholders, to increase the likelihood of the evaluation being used.l standards of a project should focus on scientific justification, utility, feasibility, propriety, and accuracy. l a program in this context includes: -direct service interventions -community mobilization efforts -research initiatives -surveillance systems -policy development activities -outbreak investigations -laboratory diagnostics -communication campaigns -infrastructure building projects -training and education services -administrative systems and others. title page -name of project; principal people and implementing organizations; contact person(s); timeframe; country (state, region); target group of project; estimated project cost; date of submission.l introduction -provides project background including the health issue(s) to be addressed, a situational analysis of the health problem, the at-risk and target populations, and existing programs in the community; includes an international and national literature review of the topic with references. budget -estimated cost of expenditures, including human resources, activities, running costs, and overheads for project and evaluation. l monitoring and evaluation -what evidence will be used to indicate how the program has performed? what plan is recommended for periodic follow-up of project activities (including timeline and measures) to implement lessons learned from positive or negative outcomes, and use of resources? how efficient and effective is the project? l conclusions -what conclusions regarding program performance may be drawn? what conclusions regarding program performance are justified by comparing the available evidence to the selected standards? l reporting -report the project to the key stakeholders and public bodies; publication in peer-reviewed journal if possible.l justification -why is this project important and timely, and how will implementation benefit health of the community?core competencies are essential knowledge, skills, and attitudes necessary for the practice of public health. they transcend the boundaries of specific disciplines and are independent of program and topic. they are the building blocks for effective public health practice, and the use of an overall public health approach.generic core competencies provide a baseline for what is required to fulfill public health system core functions. these include population health assessment, surveillance, disease and injury prevention, health promotion, and health protection.the core competencies are needed to effectively choose options, and to plan, implement, and evaluate policies and/ or programs in public health, including the management of incidents such as outbreaks and emergencies.a public health practitioner is able to: l describe selected policy and program options to address a specific public health issue l describe the implications of each option, especially as they apply to the determinants of health and recommend or decide on a course of action l develop a plan to implement a course of action taking into account relevant evidence, legislation, emergency planning procedures, regulations, and policies l implement a policy or program and/or take appropriate action to address a specific public health issue l demonstrate the ability to implement effective practice guidelines l evaluate an action, a policy, or a program l demonstrate an ability to set and follow priorities, to maximize outcomes based on available resources l demonstrate the ability to fulfill functional roles in response to a public health emergency. of the individual, the population, and the economy. because health care employs large numbers of skilled professionals and many unskilled people, it is often vital to the economic survival of small communities, as well as for a sense of community well-being.management includes planning, leading, controlling, organizing, motivating, and decision-making. it is the application of resources and personnel towards achieving targets. therefore, it involves the study of the use of resources, and the motivation and function of the people involved, including the producer or provider of service, and the customer, client, or patient. this cannot take place in a vacuum, but is based on the continuous monitoring of information and its communication to all parties involved. these functions are applicable at all levels of an estimated , french people lived with dementia; half were diagnosed and one-third were receiving treatment; percent of people with alzheimer's disease were living at home; percent of all nursing home residents lived with some form of dementia; a day's care cost € while full-time residency in a nursing home ranged between € and € . l identify the early symptoms of dementia and refer people to specialists. l create a network of "memory centers" to enable earlier diagnosis. "for millions of americans, the heartbreak of watching a loved one struggle with alzheimer's disease is a pain they know all too well. alzheimer's disease burdens an increasing number of our nation's elders and their families, and it is essential that we confront the challenge it poses to our public health. " on january , president barack obama signed into law the national alzheimer's project act (napa), requiring the secretary of the us department of health and human services (hhs) to establish the national alzheimer's project to: l create and maintain an integrated national plan to overcome alzheimer's disease (ad). l coordinate alzheimer's disease research and services across all federal agencies. l accelerate the development of treatments to prevent, halt, or reverse the course of ad. l improve early diagnosis and coordination of care and treatment of ad. l improve outcomes for ethnic and racial minority populations that are at higher risk for ad. l coordinate with international bodies to fight ad globally. the law also establishes the advisory council on alzheimer's research, care, and services and requires the secretary of hhs, in collaboration with the advisory council, to create and maintain a national plan to overcome ad. research funds are being allocated towards that end. education for health providers, strengthening of the workforce, for direct care and for public health guidelines for management of ad, education and support for caring families, addressing special housing needs for ad patients and many other initiatives are proposed in this comprehensive approach to a growing public health problem. enhancing public awareness is crucial to achieve the goals set out in this plan. key: cord- -ar xvd c authors: campbell, katherine h.; pettker, christian m.; goffman, dena title: consolidation of obstetric services in a public health emergency date: - - journal: semin perinatol doi: . /j.semperi. . sha: doc_id: cord_uid: ar xvd c though much of routine healthcare pauses in a public health emergency, childbirth continues uninterrupted. crises like covid- put incredible strains on healthcare systems and require strategic planning, flexible adaptability, clear communication, and judicious resource allocation. experiences from obstetric units affected by covid- highlight the importance of developing new teams and workflows to ensure patient and healthcare worker safety. additionally, adapting a strategy that combines units and staff from different areas and hospitals can allow for synergistic opportunities to provision care appropriately to manage a structure and workforce at maximum capacity. though much of routine healthcare pauses in a public health emergency, childbirth continues uninterrupted. crises like covid- put incredible strains on healthcare systems and require strategic planning, flexible adaptability, clear communication, and judicious resource allocation. consolidating obstetric services (within a hospital or across a health system) and adapting units to contain covid- (either within an existing labor and delivery unit or building a specialized unit for covid- antepartum, intrapartum, and postpartum patients) should be major considerations for hospital leadership. while this paper discusses the planning and organizing related to the covid- pandemic, it can apply to nearly any large-scale disaster or crisis. strategic planning for the consolidation of obstetric services at a hospital or hospital system level in response to covid- should begin as early as possible. key stakeholders involved in the comprehensive delivery of obstetrical services should be identified and brought together for assessment of ( ) ongoing obstetrical needs of the patient population; ( ) hospital resources including availability of physical space, health care workers, and supplies; and ( ) regularly scheduled teleconference meetings that are frequent, but short, are important tools to ensure reliable and timely communication. these meetings can start daily at first and then be spaced out over time as the teams feel more comfortable and problems are more settled. the teams at yale-new haven health (comprised of labor and delivery units), as well as new york presbyterian (nyp) columbia university irving medical center (cuimc) department of obstetrics and gynecology (comprised of labor and delivery units), for example, initiated daily -minute meetings at the end of the day, with a structured format to review each site. these spaced out to -times per week over time. development of a proposed consolidated obstetric service should center on the resources and needs identified during strategic planning. further expansion and refinement of the service should be guided by public health and medical recommendations published at the global, national and state levels. the world health organization (who) serves as a director and coordinator of international health within the united nations system. in addition to providing covid- related travel advice, situational reports, media resources, research and development, and mythbusters, the who provides an updated strategic preparedness and response plan that outlines public health measures to support all countries to prepare for and respond to covid- (table ) . these recommendations provide a broad platform to initiate obstetric service changes. part of the mission of the centers for disease control (cdc) is to increase the health security of the united states by conducting critical scientific research and providing health information that protects our nation against dangerous health threats and responding when these arise. the cdc provides detailed information that guides hospitals when developing an evidence-based strategy to safely care for persons infected with sars-cov- (table ) (table ) . a joint algorithm has been developed by acog and smfm to aid obstetric providers in assessing and managing pregnant women with suspected or confirmed knowledge of up to date recommendations from the who, cdc, acog and smfm are critical for accurate implementation of consolidated obstetric services. however, successful implementation of a consolidated obstetric service will be the result of a detailed understanding of the hospital or hospital system's resources and needs along with regional or state specific recommendations for infection prevention. during covid- , an obstetric service that is transformed to be adaptable, flexible, and able to pivot to the needs of the community will achieve long term success. we provide practical strategies to establish a consolidated obstetric service in response to the covid- pandemic; these strategies, guided by published recommendations and considerations, are based on real-world experience garnered from consolidation of our obstetric services during the pandemic. to borrow from the donabedian model of quality improvement, favorable outcomes in an emergency will come from establishing reliable processes and an organized structure. in terms of process, a strong effort at consolidating and organizing obstetric services depends on the establishment of clear core principles from leadership. the challenge in these situations is to manage change and uncertainty and the anxiety around that. for instance, consolidating units brings together new and unfamiliar teams; these workers need a firm platform of principles to work well together under pressure. further, as demonstrated in the covid- pandemic, uncertainty around the use and availability of ppe created considerable, and understandable, anxiety, about personal safety. what these examples demonstrate is that leadership must be guided by firm principles of transparency, discipline, and availability to resolve issues as they come up. teams mobilize and perform well when processes are guided under these conditions. the team providing the literal and figurative structure should not be considered narrowly from the onset of identifying a crisis. obstetric care spans an entire healthcare institutionambulatory, emergency department, critical care, perioperative, pediatrics-and contact should be made immediately with these services to support changes on a unit. as demonstrated by covid- , for example, many obstetric units partnered with perioperative services for when covid- pregnant patients required cesarean. efforts to consolidate obstetric units within a hospital or health system should be promptly communicated to these partners, as it will impact their volume or ability to support obstetrics. in particular, facilities, bed management, and infection prevention services should be consulted early to expedite the movement or rearrangement of services. the most important resource in a hospital is the group of frontline healthcare workers. as the covid- crisis demonstrated, frontline workers can be immensely adaptable and dependable. however, sensitivity to the limits of human physical and psychological capacity is required at the onset of a crisis, especially one predicted to last weeks or months. this should initiate advanced planning and evaluation of the pool of clinicians available to work. at the onset of the east coast covid- crisis, yale-new haven hospital and nyp cuimc department of obstetrics and gynecology accounted for all providers (physicians and midwives) trained to provide obstetric care. anticipating that a surge of infected patients, potential workforce illnesses or absences or increases in volume could overburden our capacity, we worked with our medical staff office to facilitate emergency privileges, when necessary, for supervision of labor and birth for providers not currently in active obstetric practice, such as gynecologic oncologists, urogynecologists, gynecologic specialty surgeons and family planning providers. we also worked with our liability insurance carrier (mcic vermont, inc.) to provide temporary emergency obstetric-level insurance for these providers if necessary. we also discussed the potential to give hospital privileges to obstetricians and midwives with privileges at other hospitals in our health system, given that they practice within the same guidelines and procedures, in case there were discrepancies in volume between localities, though execution of this portion of the contingency plan never became necessary. consolidating should not just be considered a structural concept. the covid- crisis demonstrated the reality that many healthcare workers could be affected and there could be a huge attrition of clinicians due to infection and illness. while we did not have to resort to this at yale, we planned for a contingency where a substantial number of obstetricians and midwives would not be able to work. at yale a majrity of deliveries are distributed across community obstetric groups composed of - covering physicians each. illnesses of - providers in any of those practices could have devastating impact on their ability to cover their patients so we discussed creating obstetric ‗supergroups' to cover inpatient services. all community groups were ready to share duty and patients for the sake of safety. as an example, to cover deliveries a month, we were ready to provide two coverage groups, each staffed by obstetrician-gynecologists, maternal-fetal medicine specialist, and - midwives at a time, supported by our resident cohort. as a pandemic progresses or other public health emergency evolves, sites may be called upon to consider reorganization of resources to free up space to accommodate surge volumes of sick patients within hospitals. a sustained yet flexible response by local and regional health systems is required to care for communities affected by covid- . reorganization of health systems in the face of a fast-moving pandemic requires numerous deft decisions be made in swift succession. although the locations where childbirth occurs may change, key stake holders involved with health system reorganization should recognize that obstetrical delivery volume across a region will likely continue at historical levels. when planning the reorganization of obstetrical services, the multidisciplinary leadership team, equipped with up to date guidance published from the who, cdc, acog and smfm should have a thorough knowledge of hospital resources and capabilities. it is critical that opportunities to consolidate both physical space and human resources preserve ongoing commitments to high levels of patient safety. the need to reorganize existing health care delivery systems during the covid- pandemic presents an unprecedented opportunity for innovation and novel use of existing technologies. we share multiple examples along with strategies undertaken to accommodate these important requests. in early april , as the covid- pandemic peaked within the new york metropolitan and surrounding areas, multiple sites within the newyork presbyterian health system identified the need for additional medical-surgical bed capacity to accommodate increasing numbers of non-obstetric adult covid- patients. while field hospitals and other off-site capacity was being created, a potential additional opportunity identified was the conversion of postpartum units in two of our community hospitals, newyork presbyterian allen hospital (ah) and newyork presbyterian lawrence hospital (lh), to accommodate additional covid- patients. to accomplish this, we looked at our care delivery models and strategized opportunities to continue to provide safe high quality obstetric care with the addition of covid- safety in mind, within our health system. it follows that if no postpartum unit is available that delivery of obstetric care needs to be carefully considered. in broad strokes, options included continued use of the labor and delivery units for triage along with labor and delivery utilizing existing labor, delivery, recovery (ldr) rooms as labor, delivery, recovery, postpartum (ldrp) rooms or the option of shifting obstetric volume to another location. the obstetric service at newyork presbyterian morgan stanley children's hospital (msch) delivers approximately patients annually with a significant proportion being high risk. ah and lh deliver and low risk patients annually, respectively. these three services are closely aligned with many shared patients, transfers between sites when indicated and a common faculty from the department of obstetrics and gynecology at columbia university irving medical center. at lh the approach immediately undertaken was to begin using the ldrs as ldrps while ensuring that additional medical surgical beds were available to ensure safety with volume surges. the approach taken at ah is described in a bit more detail due to the complexity to provide information for others who may face similar challenges. consolidation of all obstetric services from ah to msch was planned. patient notification processes were put into place and multidisciplinary teams at both sites were informed. to vacate the postpartum unit at ah, immediate planning was undertaken to facilitate safe transfer of inpatient postpartum mother and newborn dyads who were not anticipated to be eligible for discharge in the next hours. successful management of the additional obstetrical volume at msch would require additional space, continued efforts to promote patient discharge with enhanced support when medically and socially appropriate and expansion of multidisciplinary coverage, including obstetrics, anesthesiology, pediatrics, nursing and support services. multidisciplinary discussions were held and the option of caring for low risk, covid negative patients scheduled for cesareans in the msch pediatric perioperative areas was explored. or schedules from msch and ah were blended into a single schedule, leveled over the day and week and included the additional pediatric operating room. on the transition date, all ah cesareans and inductions of labor were safely completed on msch l&d, leveled throughout the day while equipment and supplies were transferred from ah to the msch pediatric or area. one operating room and pacu slots were dedicated to obstetrics and equipped with fetal monitors, newborn equipment and all necessary supplies. multidisciplinary walk throughs and simulations were run to test the new space for preoperative management, cesarean and post-operative recovery. additional surge space was identified in case the need arose for triage, labor and postpartum care. modifications were made to the approach to scheduling inductions of labor to include flexible slots throughout the day with a team leader on the unit helping to prioritize patients and bring them in throughout the day when the unit was able to accommodate. on the day after the transition and days after the need to repurpose the postpartum space was identified, the ah ob service closed. small team were maintained at ah for obstetric or gynecologic emergencies. all scheduled cesareans and inductions were completed on msch labor and delivery on the day of transition leveled throughout the day. beginning the next day, we ran one scheduled cesarean in the dedicated pediatric operating room and identified minor opportunities to optimize the process. thereafter, schedules were reviewed daily by the multidisciplinary leadership team, with attention to medical and surgical history, obstetric and neonatal risk with plans made for surgical schedule pending covid results. subsequently a full day operating room schedule was run on weekdays in the pediatric ors with a dedicated multidisciplinary team staffing cesarean deliveries and their immediate perioperative care with healthy outcomes for moms and newborns. this helped to facilitate safe care for these patients while allowing continued safe operations on our busy labor and delivery, antepartum and postpartum units. safe infection prevention and control practices were incorporated into all aspects of planning and execution but are beyond the scope of this manuscript (see xxx). while details of logistics and operations were reviewed here, there is an additional piece that was equally important to consider. when blending services, the importance of the people, relationships and communication cannot be underestimated and consideration of any opportunities to facilitate smooth interactions is crucial. during the covid- pandemic, yale new haven hospital determined brisk expansion of floor beds and icu beds reserved to care for patients infected with sars-cov- was needed. the expansion required the movement of entire medical and surgical services from one floor to another, from one campus to another. during the reorganization, needs of the two obstetrical services were assessed and the opportunity to consolidate services at one campus was explored. it was understood that consolidation to one campus would require simultaneous expansion of the combined obstetrical unit including an increase in the number of labor rooms, antepartum/postpartum rooms, dedicated or space, and well newborn rooms. the ynhh neonatal intensive care unit (located at the ysc) serves both the ysc and the src campuses so no expansion was required. consolidation of the two obstetrical services to the larger ysc campus addressed three critical needs. first, consolidation allowed optimal scheduling of available human resources including the development of contingency plans if multiple staff were infected with sars-covo and needed to be out of work. second, consolidation to a single campus ensured the available physical resources were used at or just below capacity most of the time. third, consolidation provided opportunity to create an obstetrical unit specifically to care for women affected by covid- . given the potential benefits of consolidation, the decision was made to quickly combine the two obstetrical services onto the ysc. the next step was to secure additional space to safely provide all components of obstetrical care. cancellation of elective procedures and surgeries allowed redistribution of medical and surgical services throughout ynhh and permitted accommodation of a substantial number of covid- admissions. the movement of services provided opportunity to locate and secure optimal space for the expansion of obstetrical volume at ysc. down the corridor from the ysc labor and birth unit, a medicine unit was marked for relocation. the unit consisted of two hallways of patient rooms connected by a central work station and provided ample space for conversion to an obstetrical unit to include three labor and delivery rooms, ten flex rooms that can provide antepartum/postpartum/triage/post anesthesia care, two well newborn nursery rooms with six beds total, and a single neonatal resuscitation room. additionally, the operating room set up to care for covid- positive women who required obstetrical surgery was located directly below this unit and was easily accessed via patient transport elevator. consolidation of obstetric services provided several challenges. one of the most critical challenges noted by both institutions was been the integration of two obstetrical services in the era of -social distancing‖ and the ubiquitous use of ppe that conceals the face. during noncovid- times, integration of two services would be enriched with social mixers, in person obstetric simulations, and formal educational sessions peppered with ample opportunity for impromptu conversations as two services integrated. we continue to develop ways to safely work around the personal interaction restrictions covid- requires as we learn to integrate our services while protecting our healthcare workers physical safety and emotional wellbeing. one idea of how to help do this came from the guidance of the psychiatry department with the creation and support of a weekly, one-hour -decompression huddle‖ held on the labor floor with a phone call in number. all persons working in any part of the obstetric service are welcome to participate. conversations are open, do not have an agenda and participants can contribute to the discussion as they desire. the decompression huddles provide an important forum to identify stressors, common problems, and brainstorm new ways of doing things and managing during the covid- . other strategies included the developing a physician/nurse team leader dyad with standard work to facilitate seamless function of the large team. additional creative solutions included use of brightly colored name/role stickers worn on caps to help identify team members and the use of a team board with photo magnets to clarify who is in house at any given time and the role they are currently playing within the increasingly complex team. the merriam-webster dictionary defines emergency as ( ) an unforeseen combination of circumstances or the resulting state that calls for immediate action and ( ) an urgent need for assistance or relief. in late winter , although the impending covid- pandemic felt more like a distant tsunami rolling in our direction rather than the active storm of viral transmission that was likely already occurring within our communities, the united states was in an emergency. a timely response of the obstetrical services to the covid- pandemic required well-organized cooperation between existing administrative, clinical, and educational system in order to develop a sustainable strategy. reliance on these existing systems during an emergency cannot be overemphasized. whether one is fine-tuning the management of an established obstetrical service or rebuilding one from the ground up, it is important to keep in mind that the structure and function of these systems including effective communication within and between these systems proves to be a critical, rate-limiting component of a hospital's ability to pivot and respond to any unforeseen circumstance that requires immediate action. cooperation and sharing of gained knowledge between hospitals and health systems will further benefit our ability to respond to covid- . healthcare facilities should prepare for large increases in the number of suspected cases of covid- staff should be familiar with the suspected covid- case definition, and able to deliver the appropriate care pathway prevent the spread of covid- on the obstetric unit promptly identify and isolate patients with possible covid- and inform the correct facility staff and public health authorities care for a limited number of patients with confirmed or suspected covid- as part of routine operations potentially care for a larger number of patients in the context of an escalating outbreak while maintaining adequate care for other patients monitor and manage any healthcare personnel that might be exposed to covid- communicate effectively within the facility and plan for appropriate external communication related to covid- a adopted from https://www.cdc.gov/coronavirus/ -ncov/hcp/hcp-hospital-checklist.html table . acog: hospital disaster preparedness for obstetricians and facilities providing maternity care a appoint an obstetrician and pediatrician to codirect covid- planning for maternity services with close involvement of maternity and pediatric nursing consider regional patterns of obstetric care provision during covid- pandemic consider obstetric and neonatal needs with high obstetric patient surge establish policies for visitation and lactation that balance infection prevention with patient and familial desires for involvement in the birth process foster functional working relationships with local and regional critical care clinicians have a working algorithm for ethical resource allocation when demand exceeds supply that considers obstetric-and pediatric-specific needs develop a surge capacity plan, realizing the challenges that pregnancy poses, to control patient hospital disaster preparedness for obstetricians and facilities providing maternity care. committee opinion no. . american college of obstetricians and gynecologists patients with, or at risk of, severe illness should be given priority over mild cases a high volume of cases will put staff, facilities and supplies under pressure guidance should be made available on how to manage mild cases in self-isolation, when appropriate plans to provide business continuity and provision of other essential healthcare services should be reviewed special considerations and programs should be implemented for vulnerable populations (elderly, patients with chronic diseases, pregnant and lactating women, and children) a adapted from https://www.who.int/emergencies/diseases/novel-coronavirus- /strategiesplans-and-operations. key: cord- - jzkdu authors: bickman, leonard title: improving mental health services: a -year journey from randomized experiments to artificial intelligence and precision mental health date: - - journal: adm policy ment health doi: . /s - - - sha: doc_id: cord_uid: jzkdu this conceptual paper describes the current state of mental health services, identifies critical problems, and suggests how to solve them. i focus on the potential contributions of artificial intelligence and precision mental health to improving mental health services. toward that end, i draw upon my own research, which has changed over the last half century, to highlight the need to transform the way we conduct mental health services research. i identify exemplars from the emerging literature on artificial intelligence and precision approaches to treatment in which there is an attempt to personalize or fit the treatment to the client in order to produce more effective interventions. in , i was writing my first graduate paper at columbia university on curing schizophrenia using sarnoff mednick's learning theory. i was not very modest even as a first-year graduate student! but i was puzzled as to how to develop and evaluate a cure. then, as now, the predominant research design was the randomized experiment or randomized clinical trial (rct). it was clear that simply describing, let alone manipulating, the relevant characteristics of this one disorder and promising treatments would require hundreds of variables. developing an effective treatment would take what seemed to me an incalculable number of randomized trials. how could we complete all the randomized experiments needed? how many different outcomes should we measure? how could we learn to improve treatment? how should we consider individual differences in these group comparisons? i am sure i was not insightful enough to think of all these questions back then, but i know i felt frustrated and stymied by our methodological approach to answering these questions. but i had to finish the paper, so i relegated these and similar questions to the list of universal imponderables such as why i exist. in fact, i became a committed experimentalist, and i dealt with the limitations of experiments by recognizing their restrictions and abiding by the principle "for determining causality, in many but not all circumstances, the randomized design is the worst form of design except all the others that have been tried " (bickman and reich , pp. - ) . for the much of my career, i was a committed proponent of the rct as the best approach to understanding causal relationships (bickman ) . however, as some of my writing indicates, it was a commitment with reservations. i did not see a plausible alternative or complement to rcts until recently, when i began to read about artificial intelligence (ai) and precision medicine in . the potential solution to my quandary did not crystallize until , when i collaborated with aaron lyons and miranda wolpert on a paper on what we called "precision mental health" (bickman et al. ) . with the development of ai and its application in precision medicine, i now believe that ai is another approach that we may be able to use to understand, predict, and influence human behavior. while not necessarily a substitute for rcts in efforts to improve mental health services, i believe that ai provides an exciting alternative to rcts or an adjunct to them. while i use precision medicine and precision mental health interchangeably, i will differentiate them later in this paper. toward that end, i focus much of this paper on the role of ai and precision medicine as a critical movement in the field with great potential to inform the next generation of research. before proposing such solutions, i first describe the challenges currently faced by mental health services, using examples drawn almost entirely from studies of children and youth, the area in which i have conducted most of my research. i describe five principal causes of this failure, which i attribute primarily, but not solely, to methodological limitations of rcts. lastly, i make the case for why i think ai and the parallel movement of precision medicine embody approaches that are needed to augment, but probably not replace, our current research and development efforts in the field of mental health services. i then discuss how ai and precision mental health can help inform the path forward, with a focus on similar problems manifested in mental health services for adults. these problems, i believe, make it clear that we need to consider alternatives to our predominant research approach to improving services. importantly, most of the research on ai and precision medicine i cite deals with adults, as there is little research in this area on children and youth. i am assuming that we can generalize from one literature to the other, but i anticipate that there many exceptions to this assumption. according to some estimates, more than half ( . %) of adults with a mental illness receive no treatment (mental health in america ) . less than half of adolescents with psychiatric disorders receive any kind of treatment (costello et al. ) . over % of youth with major depression do not receive any mental health treatment (mental health in america ). several other relevant facts when it comes to youth illustrate the problem of their access to services. hodgkinson et al. ( ) have documented that less than % of children in poverty receive needed services. these authors also showed that there is less access to services for minorities and rural families. when it comes to the educational system, mental health in america ( ) estimated that less than % of students have an individual education plan (iep), which students need to access school-supported services, even though studies have shown that a much larger percentage of students need those services. access is even more severely limited in in low-and middle-income countries (esponda et al. ). very few clients receive effective evidence-based quality mental health services that have been shown to be effective in laboratory-based research (garland et al. ; gyani et al. ). moreover, research shows that even when they do receive care that is labeled evidence-based, it is not implemented with sufficient fidelity to be considered evidence-based (park et al. ) . no matter how effective evidence-based treatments are in the laboratory, it is very clear that they lose much of their effectiveness when implemented in the real world (weisz et al. (weisz et al. , . research reviews demonstrate that services that are typically provided outside the laboratory lack substantial evidence of effectiveness. there are two factors that account for this lack of effectiveness. as noted above, evidencebased services are usually not implemented with sufficient fidelity to replicate the effectiveness found in the laboratory. more fundamentally, it is argued here that even evidencebased services may not be sufficiently effective as currently conceptualized. a review of published studies on school-based health centers found that while these services increased access, the review could not determine whether services were effective because the research was of such poor quality (bains and diallo ) . a meta-analysis of studies of mental health interventions implemented by school personnel found small to medium effect sizes, but only % of the services were provided by school counselors or mental health workers (sanchez et al. ) . a cochrane review concluded, "we do not know whether psychological therapy, antidepressant medication or a combination of the two is most effective to treat depressive disorders in children and adolescents" (cox et al. , p. ) . another meta-analysis of studies on school-based interventions delivered by teachers showed a small effect for internalizing behaviors but no effect on externalizing ones (franklin et al. a) . similarly, a meta-analysis of meta-analyses of universal prevention programs targeting school-age youth showed a great deal of variability with effect sizes from to . standard deviations depending on type of program and targeted outcome (tanner-smith et al. ) . a review of rcts found no compelling evidence to support any one psychosocial treatment over another for people with serious mental illnesses (hunt et al. ) . a systematic review and meta-analysis of conduct disorder interventions concluded that they have a small positive effect, but there was no evidence of any differential effectiveness by type of treatment (bakker et al. ) . fonagy and allison ( ) conclude, "the demand for a reboot of psychological therapies is unequivocal simply because of the disappointing lack of progress in the outcomes achieved by the best evidence-based interventions" (p. ). probably the most discouraging evidence was identified by weisz et al. ( ) on the basis of a review of rcts over a -year period. they found that the mean effect size for treatment did not improve significantly for anxiety and adhd and decreased significantly for depression and conduct problems. the authors conclude: in sum, there were strikingly few exceptions to the general pattern that treatment effects were either unchanged or declining across the decades for each of the target problems. one possible implication is that the research strategy used over the past decades, the treatment approaches investigated, or both, may not be ideal for generating incremental benefit over time. (p. ) there is a need-indeed, an urgent need-to change course, because our traditional approaches to services appear not to be working. however, we might be expecting too much from therapy. in an innovative approach to examining the effectiveness of psychotherapy for youth, jones et al. ( ) subjected rcts to a mathematical simulation model that estimated that even if therapy was perfectly implemented, the effect size would be a modest . . they concluded that improving the quality of existing psychotherapy will not result in much better outcomes. they also noted that ai may help us understand why some therapies are more effective than others. they suggested that the impact of therapy is limited because a plethora of other factors influence mental health, especially given that therapy typically lasts only one hour a week out of + waking hours. they also indicated that other factors that have not been included in typical therapies, such as individualizing or personalizing treatment, may increase the effectiveness of treatment. i am not alone in signaling concern about the state of mental health services. for example, other respected scholars in children's services research have also raised concerns about the quality and effectiveness of children's services. weisz and his colleagues (marchette and weisz ; ng and weisz ) described several factors that contribute to the problems identified above. these included a mismatch between empirically supported treatments and mental health care in the real world, the lack of personalized interventions, and the absence of transdiagnostic treatment approaches. it is important to acknowledge the pioneering work of sales and her colleagues, who identified the need and tested approaches to individualizing assessment and monitoring clients (alves et al. (alves et al. , elliott et al. ; alves , ; sales et al. sales et al. , . we need not only to appreciate the relevance of this work but also to integrate it with new artificial intelligence approaches described later in this paper. i am not concluding from such evidence that all mental health services are ineffective. this brief summary of the state of our services can be perceived in terms of a glass half full or half empty. in other words, there is good evidence that some services are effective under particular, but yet unspecified, conditions. however, i do not believe that the level of effectiveness is sufficient. moreover, we are not getting better at improving service effectiveness by following our traditional approach to program development, implementation, research, and program evaluation. while it is unlikely that the social and behavioral sciences will experience a major breakthrough in discovering how to "cure" mental illness, similar to those often found in the physical or biological sciences, i am arguing in this paper that we must increase our research efforts using alternative approaches to produce more effective services. a large part of this paper, therefore, is devoted to exploring what has been also called a precision approach to treatment in which there is an attempt to personalize treatment or fit treatment to the client in order to produce more effective interventions. in some of my earliest work in mental health, i identified the field's focus on system-level factors rather than on treatment effectiveness as one cause of the problems with mental health services. the most popular and well-funded approach to mental health services in the s and s, which continues even today, is called a system or continuum of care (bickman (bickman , bickman et al. b; bryant and bickman ) . this approach correctly recognized the problems with the practice of providing services that were limited to outpatient and hospitalization only, which was very common at that time. moreover, these traditional services did not recognize the importance of the role played by youth and families in the delivery of mental services. to remedy these important problems, advocates for children's mental health conceptualized that a system of care was needed, in which a key ingredient was a managed continuum of care with different levels or intensiveness of services to better meet the needs of children and youth (stroul and friedman ) . this continuum of care is a key component of a system of care. however, i believe that in actuality, these different levels of care simply represent different locations of treatment and restrictiveness (e.g., inpatient vs. outpatient care) and did not necessarily reflect a gradation of intensity of treatment. a system of care is not a specific type of program, but an approach or philosophy that combines a wide range of services and supports for these services with a set of guiding principles and core values. services and supports are supposed to be provided within these core values, which include the importance of services that are community-based, family-focused, youth-oriented, in the least restrictive environment, and culturally and linguistically proficient. system-level interventions focus on access and coordination of services and organizations and not on the effectiveness of the treatments that are provided. it appeared that the advocates of systems of care assumed that services were effective and that what was needed was to organize them better at the systems level. although proponents of systems of care indicated that they highly valued individualized treatment, especially in what were called wraparound services, there was no distinct and systematic way that individualization was operationalized or evaluated. moreover, there was not sufficient evidence that supported the assumption that wraparound services produced better clinical outcomes (bickman et al. ; stambaugh et al. ) . a key component of the system is providing different levels of care that include hospitalization, group homes, and outpatient services, but there is little evidence that clinicians can reliably assign children to what they consider the appropriate level of care (bickman et al. a ). my earliest effort in mental health services research was based on a chance encounter that led to the largest study ever conducted in the field of child and youth mental health services. i was asked by a friend to see if i could help a person whom i did not know to plan an evaluation of a new way to deliver services. this led to a project that cost about $ million to implement and evaluate. we evaluated a new system of care that was being implemented at fort bragg, a major u.s. army post in north carolina. we used a quasi-experimental design because the army would not allow us to conduct a rct; however, we were able to control for many variables by using two similar army posts as controls (bickman ; bickman et al. ) . the availability of sufficient resources allowed me to measure aspects of the program that were not commonly measured at that time, such as cost and family empowerment. with additional funding that i received from a competitive grant from the national institute of mental health (nimh) and additional follow-up funding from the army, we were able to do a cost-effectiveness analysis (foster and bickman ) , measure family outcomes (heflinger and bickman ) , and develop a new battery of mental health symptoms and functioning (bickman and athay ). in addition, we competed successfully for an additional nimh grant to evaluate another system of care in a civilian population using a rct (bickman et al. a, b) and a study of a wraparound services that was methodologically limited because of sponsor restrictions (bickman et al. ) . i concluded from this massive and concentrated effort that systems of care (including the continuum of care) were able to influence system-level variables, such as access, cost, and coordination, but that there was not sufficient evidence to support the conclusion that it produced better mental health outcomes for children or families or that it reduced costs per client . this conclusion was not accepted by the advocates for systems of care or the mental health provider community more generally. moreover, i became persona non grata among the proponents of systems of care. while the methodologists who were asked to critique on the fort bragg study saw it as an important but not flawless study (e.g., sechrest and walsh ; weisz et al. ) that should lead to new research (hoagwood ) , most advocates thought it to be a well-done evaluation but of very limited generalizability (behar ). it is important to note that the system of care approach, almost years later, remains the major child and youth program funded by the substance abuse and mental health services administration's (samhsa) center for mental health services (cmhs) to the tune of about a billion dollars in funding since the system of care program's inception in . there have been many evaluations funded as part of the samhsa program that show some positive results (e.g., holden et al. ), but, in my opinion, they are methodologically weak and, in some cases, not clearly independent. systems of care are still considered by samhsa's center for mental health services to be the premier child and adolescent program worthy of widespread diffusion and funding (substance abuse and mental health services administration ), regardless of what i believe is the weak scientific support. this large investment of capital should be considered a significant opportunity cost that has siphoned off funds and attention from more basic concerns such as effectiveness of services. sadly, based on my unsuccessful efforts to encourage change as a member of the cmhs national advisory council ( - ), i am not optimistic that there will be any modification of support for this program or shift of funding to more critical issues that are identified in this paper. in the following section, i consider some of the problems that have contributed to the current status of mental health services. my assessment of current services led me to categorize the previously described deficiencies into the five following related problem groups. the problems with the validity of diagnoses have existed for as long as we have had systems of diagnoses. while a diagnosis provides some basis for tying treatment to individual case characteristics, its major contribution is providing a payment system for reimbursement for services. research has shown that external factors such as insurance influence the diagnosis given, and the diagnosis located in electronic health records is influenced by commercial interests (perkins et al. ; taitsman et al. ) . other studies have demonstrated that the diagnosis of depression alone is not sufficient for treatment selection; additional information is required (iniesta et al. ). moreover, others have shown that diagnostic categories overlap and are not mutually exclusive (bickman et al. c) . in practice, medication is prescribed according to symptoms and not diagnosis (waszczuk et al. ) . in their thematic analysis of selected chapters of the diagnostic and statistical manual of mental disorders (dsm- ), allsopp et al. ( ) examined the heterogeneous nature of categories within the dsm- . they showed how this heterogeneity is expressed across diagnostic criteria, and explained its consequences for clinicians, clients, and the diagnostic model. the authors concluded that "a pragmatic approach to psychiatric assessment, allowing for recognition of individual experience, may therefore be a more effective way of understanding distress than maintaining commitment to a disingenuous categorical system" (p. ). moreover, in an interview, allsop stated: although diagnostic labels create the illusion of an explanation, they are scientifically meaningless and can create stigma and prejudice. i hope these findings will encourage mental health professionals to think beyond diagnoses and consider other explanations of mental distress, such as trauma and other adverse life experiences. (neuroscience news , para. ) finally, a putative solution to this muddle is nimh's research domain criteria initiative (rdoc) diagnostic guide. rdoc is not designed to be a replacement of current systems but serves as a research tool for guiding research on mental disorders systems. however, it has been criticized on several grounds. for example, heckers ( ) states, "it is not clear how the new domains of the rdoc matrix map on to the current dimensions of psychopathology" (p. ). moreover, there is limited evidence that rdoc has actually improved the development of treatments for children (e.g., clarkson et al. ) . as i will discuss later in the paper, rush and ibrahim ( ) , in their critical review of psychiatric diagnosis, predicted that ai, especially artificial neural networks, will change the nature of diagnosis to support precision medicine. if measures are going to be used in real world practice, then in addition to the classic and modern psychometric validity criteria, it must be possible to use measures sufficiently often to provide a fine-grained picture of change. if measures are used frequently, then they must be short so as not to take up clinical time (riemer et al. ) . moreover, since there is a low correlation among different respondents (de los reyes and ohannessian ), we need measures and data from different respondents including parents, clinicians, clients, and others (e.g., teachers). however, we are still lacking a systematic methodology for managing these different perspectives. since we are still unsure which constructs are important to measure, we need measures of several different constructs in order to pinpoint which ones we should administer on a regular basis. in addition to outcome measures, we need valid and reliable indicators of mediators and processes to test theories of treatment as well as to indicate short-term outcomes. we need measures that are sensitive to change to be valid measures of improvement. we need new types of measures that are more contextual, that occur outside of therapy sessions, and that are not just standardized questionnaires. we lack good measures of fidelity of implementation that capture in an efficient manner what clinicians actually do in therapy sessions. this information is required to provide critical feedback to clinicians. we also lack biomarkers of mental illness that can be used to develop and evaluate treatments that are often found in physical illnesses. this is a long and incomplete list of needs and meeting them will be difficult to accomplish without a concerted effort. there are some resources at the national institutes of health that are focused on measure development, such as patient-reported outcomes measurement system information (promis) (https ://www.healt hmeas ures.net/explo re-measu remen t-syste ms/promi s), but this program does not focus on mental health. thus, we depend upon the slow and uncoordinated piecemeal efforts of individual researchers to somehow fit measure development into their career paths. i know this intimately because when i started to be engaged with children's mental health services research, i found that the measures in use were too long, too expensive, and far from agile. this dissatisfaction led me down a long path to the development of a battery of measures called the peabody treatment progress battery riemer et al. ). this battery of brief measures was developed as part of ongoing research grants and not with any specific external support. for over a half century, i have been a committed experimentalist. i still am a big fan of experiments for some purposes (bickman ). the first independent study i conducted was my honors thesis at city college of new york in . my professor was a parapsychologist and personality psychologist, so the subject of my thesis was extrasensory perception (esp). my honors advisor had developed a theory of esp that predicted that those who were positive about esp, whom she called sheep, would be better at esp than the people who rejected esp, whom she called goats (schmeidler ) . although i did not realize it at the time, my experimentalist or action orientation was not satisfied with correlational findings that were the core of the personality approach. i designed an experiment in which i randomly assigned college students to hear a scripted talk from me supporting or debunking esp. i found very powerful results. the experimental manipulation changed people's perspective on the efficacy of esp, but i found no effect on actual esp scores. it was not until i finished my master's degree in experimental psychopathology at columbia university that i realized that i wanted to be an experimental social psychologist, and i became a graduate student at the city university of new york. however, i did not accept the predominant approach of social psychologists, which was laboratory experimentation. i was convinced that research needed to take place in the real world. although my dissertation was a laboratory study of helping behavior in an emergency , it was the last lab study i did that was not also paired with a field experiment (e.g. bickman and rosenbaum ) . one of my first published research studies as a graduate student was a widely cited field experiment (rct) that examined compliance to men in different uniforms in everyday settings (bickman a, b) . the first book i coedited, as a graduate student, was titled beyond the laboratory: field research in social psychology and was composed primarily of field experiments (bickman and henchy ) . almost all my early work as a social psychologist consisted of field experiments . i strongly supported the primacy of randomized designs in several textbooks i coauthored or coedited (alasuutari et al. ; bickman and rog ; bickman and rog ; hedrick et al. ) . while the fort bragg study i described above was a quasi-experiment (bickman ) , i was not happy that the funding agency, the u.s. army, did not permit me to use a rct for evaluating an important policy issue. as i was truly committed to using a rct to evaluate systems of care, i followed up this study with a conceptual replication in a civilian community using a rct (bickman et al. b ) that was funded by a nimh grant. while i have valued the rct and continue to do so, i have come to the conclusion that our experimental methods were developed for simpler problems. mental health research is more like weather forecasting with thousands of variables rather than like traditional experimentation, which is based on a century-old model for evaluating agricultural experiments with only a few variables (hall ) . we need alternatives to the traditional way of doing research, service development, and service delivery that recognize the complexity of disorders, heterogeneity of clients, and varied contexts of mental health services. the oversimplification of rcts has produced a blunt tool that has not served us well for swiftly improving our services. this is not to say that there has been no change in the last years. for example, the institute of education sciences, a more recent player the field of children's behavioral and mental health outcomes research, has released an informative monograph on the use of adaptive randomized trials that does demonstrate flexibility in describing how rcts can be implemented in innovative ways (nahum-shani and almirall ). the concerns about rcts are also apparent in other fields. for example, a special issue of social science and medicine focused on the limitations of rcts (deaton and cartwright ) . the contributors to this incisive issue indicated that a rct does not in practice equalize treatment and control groups. rcts do not deliver precise estimates of average treatment effects (ates) because a rct is typically just one trial, and precision depends on numerous trials. there is also an external validity problem; that is, it is difficult to generalize from rcts, especially those done in university laboratory settings. context is critical and theory confirmation/disconfirmation is important, for without generalizability, the findings are difficult to apply in the real world (bickman et al. ) . scaling up from a rigorous rct to a community-based treatment is now recognized as a significant problem in the relatively new fields of translational research and implementation sciences. in addition to scaling up, there is a major issue in scaling down to the individual client level. stratification and theory help, but they are still at the group level. the classic inferential approach also has problems with replication, clinical meaningfulness, accurate application to individuals, and p-value testing (dwyer et al. ) . the primary clinical problem with rcts is the emphasis on average treatment effects (ates) versus individual prediction. rcts emphasize postdiction, and ates lead to necessary oversimplification and a focus on group differences and not individuals. subramanian et al. ( ) gave two examples of the fallacy of averages: the first was a study to describe the "ideal woman," where they measured nine body dimensions and then averaged each one. a contest to identity the "average woman" got responses, but not a single woman matched the averages on all nine variables. in a second example, the u.s. air force in measured pilots on body dimensions to determine appropriate specifications for a cockpit. not a single pilot matched the averages on even as few as dimensions, even when their measurements fell within % of the mean value. as these examples show, the problem with using averages has been known for a long time, but we have tended to ignore this problem. we are disappointed when clinicians do not use our research findings when in fact our findings may not be very useful for clinicians because clinicians deal with individual clients and not some hypothetical average client. we can obtain significant differences in averages between groups, but the persons who actually benefit from therapy will vary widely to the extent to which they respond to the recommended treatments. thus, the usefulness of our results depends in part on the heterogeneity of the clients and the variability of the findings. the privileging of rcts also came with additional baggage. instead of trying to use generalizable samples of participants, the methodology favored the reduction of heterogeneity as a way to increase the probability of finding statistically significant results. this often resulted in the exclusion from studies of whole groups of people, such as women, children, people of color, and persons with more than one diagnosis. while discussions often included an acknowledgment of this limitation, little was done about these artificial limitations until inclusion of certain groups was required by federal funding agencies (national institutes of health, central resource for grants and funding information ) . the limitations of rcts are not a secret, but we tend to ignore these limitations (kent et al. ) . one attempt to solve the difficulty of translating average effect sizes by rcts to individualize predictions is called reference class forecasting. here, the investigator attempts to make predictions for individuals based on "similar" persons treated with alternative therapies. however, it is rarely the case that everyone in a clinical trial is influenced by the treatment in the same way. an attempt to reduce this heterogeneity of treatment effects (hte) by using conventional subgroup analysis with one variable at a time is rejected by kent et al. ( ) . they argue that this approach does not work. first, there are many variables on which participants can differ, and there is no way to produce the number of groups that represent these differences. for example, matching on just binary variables would produce over a million groups. moreover, one would have to start with an enormous sample to maintain adequate statistical power. the authors describe several technical reasons for not recommending this approach to dealing with the hte problem. they also suggested two other statistical approaches, risk modeling and treatment effect modeling, that may be useful, but more research on both is needed to support their use. kent et al. ( ) briefly discussed using observational or non-rct data, but they pointed out the typical problems of missing data and other data quality issues as well as the difficulty in making causal attributions. moreover, they reiterated their support for the rct as the "gold standard." although published in , their article mentioned machine learning only as a question for future research-a question that i address later in this paper. i will also present other statistical approaches to solving the limitations of rcts. there is another problem in depending upon rcts as the gold standard. nadin ( ) pointed out that failed reproducibility occurs almost exclusively in life sciences, in contrast to the physical sciences. i would add that the behavioral sciences have not been immune from criticisms about replicability. the open science collaboration ( ) systematically sampled results from three top-tier journals in psychology, and only % of the replication efforts yielded significant findings. this issue is far from resolved, and it is much more complex than simple replication (laraway et al. ) . nadin ( ) considered the issue of the replicability as evidence of an underlying false assumption about treating humans as if they were mechanistic physical objects and not reactive human beings. he noted that physics is nomothetic, while biology is idiographic, meaning that the former is the study of the formulation of universal laws and the latter deals with the study of individual cases or events. without accurate feedback, there is little learning (kluger and denisi ) . clinicians are in a low feedback occupation, and unlike carpenters or surgeons, they are unlikely to get direct accurate feedback on the effects of their activities. when carpenters cut something too short, they can quickly see that it no longer fits and have to start with a new piece, so they typically follow the maxim of measure twice, cut once. because clinicians in the real world of treatment do not get direct accurate feedback on client outcomes, especially after clients leave treatment, then they are unlikely to learn how to become more effective clinicians from practice alone. clinical practice is thus similar to an archer's trying to improve while practicing blindfolded (bickman ) . moreover, the services research field does not learn from treatment as usual in the real world, where most treatment occurs, because very few services collect outcome data, let alone try to tie these data to clinician actions (bickman b) . there are two critical requirements needed for learning. the first is the collection of fine-grained data that are contemporaneous with treatment. the second is the feedback of these data to the clinician or others so that they can learn from these data. learning can be accomplished with routine use of measures such as patient outcome measures (poms) and feedback through progress monitoring, measurementbased care (mbc), and measurement feedback systems (mfs). these measurement feedback concepts have repeatedly demonstrated their ability to improve outcomes in therapy across treatment type and patient populations (brattland et al. ; bickman et al. ; dyer et al. ; gibbons ; gondek et al. ; lambert et al. ) . despite this evidence base, most clinicians do not use these measurement feedback systems. for example, in one of the largest surveys of canadian psychologists, only % were using a progress monitoring measure (ionita et al. ) . a canadian psychological association task force (tasca et al. ) reinforced the need for psychologists to systematically monitor and evaluate their services using continuous monitoring and feedback. they stated that the association should encourage regulatory bodies to prioritize training in their continuing education and quality assurance requirements. moreover, lewis et al., in their review of measurement-based care ( ), presented a -point research agenda that captures much the ideas in the present paper: ( ) harmonize terminology and specify mbc's core components; ( ) develop criterion standard methods for monitoring fidelity and reporting quality of implementation; ( ) develop algorithms for mbc to guide psychotherapy; ( ) test putative mechanisms of change, particularly for psychotherapy; ( ) develop brief and psychometrically strong measures for use in combination; ( ) assess the critical timing of administration needed to optimize patient outcomes; ( ) streamline measurement feedback systems to include only key ingredients and enhance electronic health record interoperability; ( ) identify discrete strategies to support implementation; ( ) make evidence-based policy decisions; and ( ) align reimbursement structures. (p. ) it is not surprising that the measurement feedback approach has not yet produced dramatic effects, given how little we know about what data to collect, how often it should be collected, what feedback should be, and when and how it should be provided (bickman et al. ) . regardless, every time a client is treated, it is an opportunity to learn how to be more effective. by not collecting and analyzing information from usual care settings, we are missing a major opportunity to learn from ordinary services. the most successful model i know of using this real-world services approach is the treatment of childhood cancers in hospitals where most children enter a treatment rct (o'leary et al. ) . these authors note that in the past years, the survival rates for childhood cancer have climbed from % to almost %. they attribute this remarkable improvement to clinical research through pediatric cooperative groups. this level of cooperation is not easy to develop, and it is not frequently found in mental health services. most previous research shows differential outcomes among different types of therapies that are minor at most (wampold and imel ) . for example, weisz et al. ( ) report that in their meta-analysis, the effect of treatment type as a moderator was not statistically significant but there was a significant, but not clearly understood, treatment type by informant interaction effect. in addition, the evidence that therapists have a major influence on the outcomes of psychotherapy is still being hotly debated. the fact that the efficacy of therapists is far from a settled issue is troubling (anderson et al. ; goodyear et al. ; hill et al. ; king and bickman ) . also, current drug treatment choices in psychiatry are successful in only about % of the patients (bzdok and meyer-lindenberg ) and are as low as - % for antidepressants (dwyer et al. ) . while antidepressants are more effective than placebos, they have small effect sizes (perlis ) , and the choice of specific medicine is a matter of trial and error in many cases. it is relatively easy to distinguish one type of drug from another but not so for services, where even dosage in psychosocial treatments is hard to define. according to dwyer et al. ( ) , "currently, there are no objective, personalized methods to choose among multiple options when tailoring optimal psychotherapeutic and pharmacological treatment" (p. ). a recent summary concluded that after years and studies, it is unknown which patients benefit from interpersonal psychotherapy (ipt) versus another treatment (bernecker et al. ) . however, to provide a more definitive answer to the question about which treatments are more effective, we need head-to-head direct comparisons between different treatments and network meta-analytic approaches such as those used by dagnea et al. ( ) . the field of mental health is not alone in finding that many popular medications do not work with most of the people who take them. nexium, a common drug for treating heartburn, works with only person out of , while crestor, used to treat high cholesterol, works with only out of (schork ) . this poor alignment between what the patient needs, and the treatment provided is the primary basis for calling for a more precise medicine approach. this lack of precision leads to the application of treatments to people who cannot benefit from it, thus leading to overall poor effectiveness. in summary, a deep and growing body of work has led me to conclude that we need additional viable approaches to a rct when it comes to conducting services-related research. an absence of rigorous evaluation of treatments that are usually provided in the community contributes to a gap in our understanding why treatments are ineffective (bickman b) . poor use of measurement in routine care (bickman ) and the absence of measurement feedback systems and clinician training and supervision (garland et al. ) are rampant. there also a dire need for the application of more advanced analytics and data mining techniques in the mental health services area (bickman et al. ). these and other such challenges have in turn informed my current thinking about alternative or ancillary approaches for addressing the multitude of problems plaguing the field of mental health services. the five problems i have described above constitute significant obstacles to achieving accessibility, efficiency, and effectiveness in mental health services. nevertheless, there is a path forward that i believe can help us reach these goals. artificial intelligence promises to transform the way healthcare is delivered. the core of my recommendations in this paper rests on the revolutionary possibilities of artificial intelligence for improving mental healthcare through precision medicine that allows us to take into account the individual variability that exists with respect to genetic and other biological, environmental, and lifestyle characteristics. several others have similarly signaled a need for considering the use of personalized approaches to service delivery. for example, weisz and his colleagues (marchette and weisz ; ng and weisz ) called for more idiographic research and for studies tailoring strategies in usual care. kazdin ( ) focused on expanding mental health services through novel models of intervention delivery; called for task shifting among providers; advocated designing and implementing treatments that are more feasible, using disruptive technologies, for example, smartphones, social media such as twitter and facebook, and socially assistive robots; and emphasized social network interventions to connect with similar people. ai is currently used in areas ranging from prediction of weather patterns to manufacturing, logistic planning to determine efficient delivery routes, banking, and stock trading. ai is used in smartphones, cars, planes, and the digital assistants siri and alexa. in healthcare, decision support, testing and diagnosis, and self-care also use ai. ai can sort through large data sets and uncover relationships that humans cannot perceive. through learning that occurs with repeated, rapid use, ai surpasses the abilities of humans only in some areas. however, i would caution potential users that there are significant limitations associated with ai that are discussed later in this paper. rudin and carlson ( ) present a non-technical and well written review of how to utilize ai and of some of the problems that are typically encountered. ai is not one type of program or algorithm. machine learning (ml), a major type of ai, is the construction of algorithms that can learn from and make predictions based on data. it can be ( ) supervised, in which the outcome is known and labeled by humans and the algorithm learns to get that outcome; ( ) unsupervised, when the program learns from data to predict specific outcomes likely to come from the patterns identified; and ( ) reinforcement learning, in which ml is trial and error. in most cases, there is an extensive training data set that the algorithm "learns" from, followed by an independent validation sample that tests the validity of the algorithm. other variations of ai include random forest, decision trees, and the support vector machine (svm), a multivariate supervised learning technique that classifies individuals into groups (dwyer et al. ; shrivastava et al. ). the latter is most widely used in psychology and psychiatry. artificial neural networks (anns) or "neural networks" (nns) are learning algorithms that are conceptuality related to biological neural networks. this approach can have many hidden layers. deep learning is a special type of machine learning. it helps to build learning algorithms that can function conceptually in a way similar to the functioning of the human brain. large amounts of data are required to use deep learning. ibm's watson won jeopardy with deepqa algorithms designed for question answering. as exemplified by the term neural networks, algorithm developers appear to name their different approaches with reference to some biological process. genetic algorithms are based on the biological process of gene propagation and the methods of natural selection, and they try to mimic the process of natural evolution at the genotype level. it has been a widely used approach since the s. natural language processing (nlp) involves speech recognition, natural language understanding, and natural language generation. nlp may be especially useful in analyzing recordings of a therapy session or a therapist's notes. affective computing or sentiment analysis involves the emotion recognition, modeling, and expression of emotion by robots or chatbots. sentiment analysis can recognize and respond to human emotions. virtual reality and augmented reality are human-computer interfaces that allow a user to become immersed within and interact with computer-generated simulated environments. hinton ( ) , a major contributor to research on ai and health, described ai as the use of algorithms and software to approximate human cognition in the analysis of complex data without being explicitly programmed. the primary aim of health-related ai applications is to analyze relationships between prevention or treatment techniques and patient outcomes. ai programs have been developed and applied to practices such as diagnosis processes, treatment protocol development, drug development, personalized medicine, and patient monitoring and care. deep learning is best at modeling very complicated relationships between input and outputs and all their interactions, and it sometimes requires a very large number of cases-in the thousands or tens of thousands-to learn. however, there appears to be no consensus about how to determine, a priori, the number of cases needed, because the number is highly dependent on the nature of the problem and the characteristics of the data. ai is already widely used in medicine. for example, in ophthalmology, photos of the eyes of persons with diabetes were screened with % specificity and % sensitivity in detecting diabetes (gargeya and leng ) . one of the more prolific uses of ai is in the diagnosis of skin cancer. in a study that scanned , clinical images, the ai approach had accuracy similar to that of board-certified dermatologists (esteva et al. ) . cardiovascular risk prediction with ml is significantly improved over established methods of risk prediction (krittanawong et al. ; weng et al. ). however, a study by desai et al. ( ) found only limited improvements in predicting heart failure over traditional logistic regression. in cancer diagnostics, ai identified malignant tumors with % accuracy compared to % accuracy for human pathologists (liu et al. ). the ibm's watson ai platform took only min to analyze a genome of a patient with brain cancer and suggest a treatment plan, while human experts took h (wrzeszczynski et al. ) . ai has also been used to develop personalized immunotherapy for cancer treatment (kiyotani et al. ). rajpurkar et al. ( ) compared chest x-rays for signs of pneumonia using a state-of-the-art -layer convolutional neural network (cnn) program with a "swarm" of radiologists (groups connected by swarm algorithms) and found the latter to be significantly more accurate. in a direct comparison between radiologists on , interpretations and a stand-alone deep learning ai program designed to detect breast cancer in mammography, the ai program was as accurate as the radiologists (rodriguez-ruiz et al. ). as topol ( b) noted, ai is not always the winner in comparison with human experts. moreover, many of these applications have not been used in the real world, so we do not know how well ai will scale up in practice. topol describes other concerns with ai, many of which are discussed later in this paper. finally, many of the applications are visual, such as pictures of skin or scans, for which ai is particularly well suited. large banks of pictures often form the training and testing data for this approach. in mental health, visual data are not currently as relevant. however, there is starting to be some research on facial expressions in diagnosing mental illness. for example, abdullah and choudhury ( ) cite several studies that showed that patients with schizophrenia tend to show reduced facial expressivity or that facial features can be used to indicate mental health status. more generally, there is research showing how facial expressions can be used to indicate stress (mayo and heilig ) . visual data are ripe for exploration using ai. although an exhaustive review of the ai literature and its applications is well beyond the focus of this paper, rudin and carlson ( ) present a well-written, non-technical review of how to utilize ai and of some of the problems that are typically encountered. topol ( a) , in his book titled deep medicine: how artificial intelligence can make healthcare human again, includes a chapter on how to use of ai in mental health. topol ( b) also provides an excellent review of ai and its application to health and mental health in a briefer format. buskirk et al. ( ) and y. liu et al. ( ) provide well-written and relatively brief introductions to ml's basic concepts and methods and how they are evaluated. a more detailed introduction to deep learning and neural networks is provided by minar and naher ( ) . in most cases, i will use the generic term ai to refer to all types of ai unless the specific type of ai (e.g., ml for machine learning, dl for deep learning, and dnn for deep neural networks) is specified. precision medicine has been defined as the customization of healthcare, with medical decisions, treatments, practices, or products being tailored to the individual patient (love-koh et al. ) . typically, diagnostic testing is used for selecting the appropriate and best therapies based a person's genetic makeup or other analysis. in an idealized scenario, a person may be monitored with hundreds of inputs from various sources that use ai to make predictions. the hope is that precision medicine will replace annual doctor visits and their granular risk factors with individualized profiles and continuous longitudinal health monitoring (gambhir et al. ) . the aim of precision medicine, as stated by president barack obama when announcing his precision medicine initiative, is to find the long-sought goal of "delivering the right treatments, at the right time, every time to the right person" (kaiser ) . both ai and precision medicine can be considered revolutionary in the delivery of healthcare, since they enable us to move from one-size-fits-all diagnoses and treatment to individualized diagnoses and treatments that are based on vast amounts of data collected in healthcare settings. the use of ai and precision medicine to guide clinicians will change diagnoses and treatments in significant ways that will go beyond our dependence on the traditional rct. precision medicine should also be seen as evolutionary since even hippocrates advocated personalizing medicine (kohler ) . the importance of a precision medicine approach was recognized in the field of prevention science with a special issue of prevention science devoted to that topic (august and gewirtz ) . the articles in this special issue recognize the importance of identifying moderators of treatment that predict heterogeneous responses to treatment. describing moderators is a key feature of precision medicine. once these variables are discovered, it becomes possible to develop decision support systems that assist the provider (or even do the treatment assignment) in selecting the most appropriate treatment for each individual. this general approach has been tried using a sequential multiple assignment randomized trial (smart) in which participants are randomized two to three times at key decision points (august et al. ) . what i find notable about this special issue is the absence of any focus on ai. the articles were based on a conference in october , and apparently the relevance of ai had not yet influenced these very creative and thoughtful researchers at that point. precision medicine does not have an easy path to follow. x. liu et al. ( b) describe several challenges, including the following three. large parts of the human genome are not well enough known to support analyses; for example, almost % of our genetic code is unknown. it is also clear that a successful precision medicine approach depends on having access to large amounts of data at multiple levels, from the genetic to the behavioral. moreover, these data would have be placed into libraries that allow access for researchers. the u.s. federal government has a goal of establishing such a library with data on one million people through nih's all of us research program (https ://allof us.nih.gov/). recruitment of volunteers who would be willing to provide data and the "harmonization" of data from many different sources are major issues. x. liu et al. ( b) also point to ethical issues that confront precision medicine, such as informed consent, privacy, and predictions that someone may develop a disease. these issues are discussed later in this paper. chanfreau-coffinier et al. ( ) provided a helpful illustration of how precision medicine could be implemented. they convened a conference of veterans affairs stakeholders to develop a detailed logic model that can be used by an organization planning to introduce precision medicine. this model includes components typically found in logic models, such as inputs (clinical and information technology), big data (analytics, data sources), resources (workforce, funding) activities (research), outcomes (healthcare utilization), and impacts (access). the paper also includes challenges to implementing precision medicine (e.g., a poorly trained workforce) that apply to mental health. ai has the potential to unscramble traditional and new diagnostic categories based on analysis of biological/genetic and psychological data, and in addition, more data will likely be generated now that the potential for analysis has become so much greater. ai also has the potential to pinpoint those individuals who have the highest probability of benefiting from specific treatments and to provide early indicators of success or failure of treatment. research is currently being undertaken to provide feedback to clinicians at key decision points as an early warning of relapse. fernandes et al. ( ) describe what the authors call the domains related to precision psychiatry (see fig. ). these domains include many approaches and techniques, such as panomics, neuroimaging, cognition, and clinical characteristics, that form several domains including big data and molecular biosignature; the latter includes biomarkers. the authors include data from electronic health records, but i would also include data collected from treatment or therapy sessions as well as data collected outside of these sessions. these domains can be analyzed using biological and computational tools to produce a biosignature, a higher order domain that includes data from all the lower level techniques and approaches. this set of biomarkers in the biosignature should result in improved diagnosis, classification, and prognosis, as well as individualized interventions. the authors note that this bottom-up approach, from specific approaches to domains to the ultimate biosignature, can also be revised to a top-down approach, with the biosignature studied to better understand domains and its specific components. the bottom of the figure shows a paradigm shift where precision psychiatry contributes to different treatments being applied to persons with different diagnoses and endophenotypes, producing different prognoses. endophenotypes is a term used in genetic epidemiology to separate different behavioral another perspective on precision psychiatry is presented by bzdock and meyer-lindberg ( ). both models contain similar concepts. both start with a group of persons containing multiple traditional diagnoses. bzdock and meyer-lindberg recognize that these psychiatric diagnoses are often artificial dichotomies. machine learning is applied to diverse data from many sources and extracts hidden relationships. this produces different subgroups of endophenotypes. machine learning is also used to produce predictive models of the effects of different treatments instead of the more typical trial and error. further refinement of the predictive ml models results in better treatment selection and better prediction of the disease trajectory. an excellent overview of deep neural networks (dnns) in psychiatry and its applications is provided by durstewitz et al. ( ) . in addition to explaining how dnns work, they provide some suggestions on how dnns can be used in clinical practice with smartphones and large data sets. a major feature of deep neural networks is their ability to learn and adapt with experience. while dnns typically outperform ml, the authors state that they do not fully understand why this is the case. in mental health, dnns have been mostly used in diagnosis and predictions but not in designing personalized treatments. dnn's ability to integrate many different data sets (e.g., various neuroimaging data, movement patterns, social media, and genomics) should provide important insights on how to personalize treatments. regardless of the model used, eyre et al. ( ) remind us that consumers should not be left out of the development of precision psychiatry. in my conceptualization of precision medicine, precision mental health encompasses precision psychiatry and any other precision approach such as social work that focuses on mental health (bickman et al. ). there has not been much written about using a precision approach with psychosocial mental health services. possibly it is psychiatry's close relationship to general medicine and its roots in biology that make psychiatry more amenable to the precision science approach. in addition, the use of the precision construct is being applied in other fields, as exemplified by the special issue of the journal of school psychology devoted to precision education (cook et al. ) and precision public health (kee and taylor-robinson ) . however, in this paper i am primarily addressing the use of psychosocial treatment of mental health problems, which differs in important ways from psychiatric treatment. for example, precision psychosocial mental health treatment does not have a strong biological/medical perspective and does not focus almost exclusively on medication; instead, it emphasizes psychosocial interventions. psychosocial mental health services are also provided in hospital settings, but their primary use is in community-based services. these differences lead to different data sources for ai analyses. it is highly unlikely that electronic mental healthcare records found outside of hospital settings contain biological and genomic data (serretti ) . but hospital records are not likely to contain the detailed treatment process data that could possibly be found in community settings. the genomic and biological data offer new perspectives but may not be informative until we have a better understanding about the genomic basis of mental illness. in addition, the internet of things and smart healthcare connect wearable and home-based sensors that can be used to monitor movement, heart rate, ecg, emg, oxygen level, sleep, and blood glucose, through wi-fi, bluetooth, and related technologies. (sundaravadivel et al. ) . with wider use of very fast g internet service, there will be a major increase in the growth of the internet of things. i want to emphasize that applying precision medicine concepts to mental health services, especially psychotherapy, is a very difficult undertaking. the data requirements for psychosocial mental health treatment are more similar to meteorology or weather forecasting than to agriculture, which is considered the origin of the rct design. people's affect, cognition, and behavior are constantly changing just like the variables that affect weather. but unlike meteorology, which is mainly descriptive and not yet engaged in interventions, mental health services are interventions. thus, in addition to client data, we must identify the variables that are critical to the success of the intervention. we are beginning to grasp how difficult this task is as we develop greater understanding that the mere labeling of different forms of treatment by location (e.g., hospital or outpatient) or by generic type (e.g., cognitive behavior therapy) is not sufficiently informative. moreover, the emergence of implementation sciences has forced us to face the fact that a treatment manual describes only some aspects of the treatments as intended but does not describe the treatment that is actually delivered. nlp is a step in the right direction in trying to capture some aspects of treatment as actually delivered. data quality is the foundation upon which ai systems are built. while medical records are of higher technical quality than community-based data because they must adhere to national standards, i believe that the nascent interest in measurement-based care and measurement feedback systems in community settings bodes well for improved data systems in the future. moreover, although electronic hospitalbased data may be high quality from a technical viewpoint (validity, reliability) and be very large, they probably do not contain the data that are valuable for developing and evaluating mental health services. the development of electronic computer-based data collection and feedback systems will become more common as the growth in ai demands large amounts of good-quality treatment and finer grained longitudinal outcome data. there is a potential reciprocal relationship between the ai needs for large, high-quality data sets and the development of new measurement approaches and the electronic systems needed to collect such data (bickman a; bickman et al. a bickman et al. , . to accomplish this with sufficiently unbiased and valid data will be a challenge. ai can bypass many definitional problems by not using established diagnostic systems. ml can use a range of variables to describe the individual ml classifier systems (tandon and tandon ) . moreover, additional sources of data that help in classification are now feasible. for example, automated analysis of social media including tweets and facebook can detect depression, with accuracy measured by area under the curve (auc) ranging from . to . compared to clinical interviews with aucs of . (guntuku et al. ). as noted earlier, dnns have been shown to be superior to other machine learning approaches in general and specifically in identifying psychiatric stressors for suicide from social media (du et al. ). predictions of , adolescent suicides with ml showed high accuracy (auc > . ) and outperformed traditional logistic regression analyses ( . - . aucs) (tandon and tandon ) . saxe has published a pioneering proof of concept that has demonstrated that ml methods can be used to predict child posttraumatic stress (saxe et al. ) . ml was more accurate than humans in predicting social and occupational disability with persons in high-risk states of psychosis or with recent-onset depression (koutsouleris et al. a) . machine learning has also been used in predicting psychosis using everyday language (rezaii et al. ) . another application of ai to diagnosis is provided by kasthurirathne et al. ( ) . they demonstrated the ability to automate screening for , adult patients in need of advanced care for depression using structured and unstructured data sets covering acute and chronic conditions, patient demographics, behaviors, and past service use history. the use of many existing data elements is a key feature and thus does not depend on single screening instruments. the authors used this information to accurately predict the need for advanced care for depression using random forest classification ml. milne et al. ( ) recognized that in implementing online peer counseling, professionals need to participate and/or provide safety monitoring in using ai. however, cost and scalability issues appeared to be insurmountable barriers. what is needed is an automated triage system that would direct human moderators to cases that require the most urgent attention. the triage system milne et al. developed sent human moderators color-coded messages about their need to intervene. the algorithm supporting this triage system was based on supervised ml. the accuracy of the system was evaluated by comparing a test set of manually prioritized messages with the ones developed through the algorithm. they used several methods to judge accuracy, but their main one was an f-measure, or the harmonic mean of recall (i.e., sensitivity) and precision (i.e., positive predictive value). regression analysis indicated that the triage system made a significant and unique contribution to reducing the time taken to respond to some messages, after accounting for moderator and community activity. i can see the potential for this and similar ai approaches to deal with the typical service setting where some degree of supervision is required but even intermittent supervision is not feasible or possible. another use of ml as a classification tool is provided by pigoni et al. ( ) . in their review of treatment resistant depression, they found that ml could be used successfully to classify responders from non-responders. this suggested that stratification of patients might help in selecting the appropriate treatment, thus avoiding giving patients treatments that are unlikely to work with them. a more general systematic review and meta-analysis of the use of ml to predict depression are provided by lee et al. ( ) . the authors found qualitative and quantitative studies that qualified for inclusion in their review. while most of the studies were retrospective, they did find predictions with an average overall accuracy of . . kaur and sharma ( ) reviewed the literature on diagnosis of ten different psychological disorders and examined the different data mining and software approaches (ai) used in different publications. depending on the disorder and the software used, the accuracy ranged from to %. accuracy was defined differently depending on the study. only % of the articles exploring diagnosis of any health problem were found to be for psychological problems. this suggests that we need more studies on diagnosis and ai. a very informative synthesis and review are provided by low et al. ( ) . they screened studies and reviewed the that met the inclusion criterion: studies from the last years using speech to identify the presence or severity of disorders through ml methods. they concluded that ml could be predictive, but confidence in any conclusions was dampened by the general lack of cross-validation procedures. the article contains very useful information on how best to collect and analyze speech samples. another innovative approach using ml focused on wearable motion detector sensors, in which these devices were worn for s during a -s mood induction task (seeing a fake snake). these data were able to distinguish children with an internalizing disorder from controls with % accuracy (mcginnis et al. ) . this approach has potential for screening children for this disorder. a problem that seemingly has been ignored by most studies that deal with classification or diagnosis is the gold standard by which accuracy is judged. in most cases, the gold standard is human judgment, which is especially fallible when it comes to mental health diagnosis. we can clearly measure whether the ai approach is faster and less expensive than human judgment, but is the ultimate in ai accuracy matching human judgment with all its flaws? i believe that the endpoint that must also be measured is client clinical mental health improvement. a system that provides faster and less expensive diagnosis but does not lead to more precise treatment and better clinical outcomes will save us time and money, which are important, but they will not be the breakthrough for which we are looking. a solution to the problems described above will involve the integration of causal discovery methods with ai approaches. ai methods are capable of improving our capacity to predict outcomes. to enhance predictability, we will need to identify the factors in the predictive models that are causal. thus, there is the need to identify techniques that provide us with causal knowledge, which currently is based primarily on rcts. but, for real-world and ethical reasons, human etiological experiments can rarely be conducted. fortunately, there are newer ai methods that can be used to infer causes, which include well validated tests of conditional independencies based on the causal markov condition (pearl ; aliferis et al. ; saxe ) . these methods have been successfully used outside of psychiatry (sachs et al. ; ramsey et al. ; statnikov et al. ) and have, in the last five years, been applied in research on mental health, largely by the team of glenn saxe at new york university and constantin aliferis and sisi ma at university of minnesota. this group has reported causal models of ptsd in hospitalized injured children (saxe et al. (saxe et al. , , children seen in outpatient trauma centers (saxe et al. ) , maltreated children (morales et al. ) , adults seen in emergency rooms (galatzer-levy et al. ) , and police officers who were exposed to trauma (saxe et al. in press ). saxe ( ) recently described the promise of these methods for psychiatric diagnosis and personalized precision medicine. new measures need to be developed that cover multiple domains of mental health, are reported by different respondents (e.g., child, parent, clinician), and are very brief. cohen ( ) provides an excellent overview of what he calls ambulatory biobehavioral technologies in a special section of psychological assessment. he notes that the development of mobile devices can have a major impact on psychological assessment. he cautions, however, that while some of these approaches have been used for decades, they still have not progressed beyond the proof of concept phase for clinical and commercial applications. ecological momentary assessment (ema) is a relatively new approach to measurement development. ema is the collection of real-time data collected in naturalistic environments. this approach uses a wide range of smart watches, bands, garments, and patches with embedded sensors (gharani et al. ; pistorius ) . for example, using smartphones, researchers have identified gait features for estimating blood alcohol content level (gharani et al. ). other researchers have been able to map changes in emotional state ranging from sad to happy by using a movement sensor on smart watches (quiroz et al. ) . others have described real-time fluctuations in suicidal ideation and its risk factors, using an average of . assessments per day (kleiman et al. ) . social anxiety has been assessed from global positioning data obtained from smart watches by noting that socially anxious students were found to avoid public places and to spend more time at home than in leisure activities outside the home (boukhechba et al. ) . a review of studies using ema concluded that the compliance rate was moderate but not optimal and could be affected by study design (wen et al. ). this review is also a good source of descriptions of different approaches to using ema. another good summary that focused on ema in the treatment of psychotic disorders can be found in bell et al. ( ) . for ema use in depression and anxiety, schueller et al. ( ) is a good source. ema has been used to measure cardiorespiratory function, movement patterns, sweat analysis, tissue oxygenation, sleep, and emotional state (peake et al. ) . harari et al. ( ) present a catalog of behavior in more than aspects of daily living that can be used in studying physical movement, social interactions, and daily activities. these include walking, speaking, text messaging, and so on. these all can be collected from smartphones and serve as an alternative to traditional survey approaches. however, it is still not clear what higher-level constructs are measured using these approaches. a comprehensive and in-depth review of studies that have used speech to assess psychiatric disorders is provided by low et al. ( ) . they conclude that speech processing technology could assist in mental health assessments but believe that there are many obstacles to this use, including the need for longitudinal studies. another interesting application for children is the use of inexpensive screening for internalizing disorders. mcginnis et al. ( ) monitored the child's motion for s using a commercially available and inexpensive wearable sensor. using a supervised ml approach, they obtained an % accuracy ( % sensitivity, % specificity) compared to similar clinical threshold on parent-reported child symptoms that differentiate children with an internalizing diagnosis from controls without such a diagnosis. in a systematic review of ema use in major depression, colombo et al. ( ) evaluated studies that met their criteria for inclusion. these studies measured a wide variety of variables including self-reported symptoms, sleep patterns, social contacts, cortisol, heart rate, and affect. they point out many of the advantages of using emas such as realtime assessments, capturing the dynamic nature of change, improving generalizability, and providing information about context. they believe that the use of emas has resulted in novel insights about the nature of depression. they do note that there are few evaluations of these measures, and there is not much use in actual clinical practice. mohr et al. ( ) note that most of the research on ema has been carried out primarily by computer scientists and engineers using a very different research model than social and behavioral scientists. while computer scientists are mostly interested in exploratory proof of concepts approach (does it work at all?) using very small samples, social/behavioral scientists are more typically theory driven and investigate under what conditions the intervention will work. mental health care, apart from medication, is almost exclusively verbal. several approaches have been tried to capture the content of treatment sessions. my colleagues and i have tried by asking clinicians to use a brief checklist of topics discussed after each therapy session . although this technique produced some interesting findings such as the identification of topics that the clinician did not discuss but that were believed to be important by the youth or parent, it is clearly filtered by what the clinician recalls and is willing to check off as having been discussed. while recordings provide a richer source of information, coding recordings manually is too expensive and slow for the real world of service delivery. the content of therapy sessions, including notes kept by clinicians, is pretty much ignored by researchers because of the difficulty and cost of manually coding those sources. however, advances in natural language processing (nlp) are now being explored as a way of capturing aspects of the content of therapy sessions. for example, tanana et al. ( ) have shown how two types of nlp techniques can be used to study and code the use of motivational interviewing in taped sessions. carcone et al. ( ) also showed that they could accurately code motivational interviewing (mi) clinical encounter transcripts with sufficient accuracy. other researchers have used ai to analyze speech to distinguish between what they called high-and low-quality counselors (pérez-rosas et al. ). some colleagues and i have submitted a proposal to nimh to refine nlp tools that can be used to supervise clinicians implementing an evidence-based treatment using ai. as far as we know, using nlp to measure fidelity and provide feedback to clinicians has not been studied in a systematic way. while ai appears to be an attractive approach to new ways of analyzing data, it should be noted that, as always, the quality of the analysis is highly dependent on the quality of the data. jacobucci and grimm ( ) caution us that "in psychology specifically, the impact of machine learning has not been commensurate with what one would expect given the complexity of algorithms and their ability to capture nonlinear and interactive effects" (p. ). one observation made by these authors is that the apparent lack of progress in using ai may be caused by "throwing the same set of poorly measured variables that have been analyzed previously into machine learning algorithms" (p. ). they note that this is more than the generic garbage in, garbage out problem, but it is specifically related to measurement error, which can be measured relatively accurately. as described earlier, our privileging of rcts has contributed to a lack of focus on a precision approach to mental health services. this has resulted in the problem of ignoring the clinical need for predicting for an individual in contrast to establishing group difference, the approach favored by the experimentalist/ hypothesis testing tradition. ai offers an approach to the discovery of important relationships in mental health in addition to rcts that are based on singlesubject prediction accuracy and not null hypothesis testing (bzdok and karrer ) . saxe et al. ( ) have demonstrated the use of the complex-systems-causal network method to detect causal relationships among variables and bivariate relations in a psychiatric study using algorithms. a comprehensive review and meta-analysis of machine learning algorithms that predict outcomes of depression showed excellent accuracy ( . ) using multiple forms of data (lee et al. ) . it is interesting to note that none of the scholars commenting on the rct special issue in social science and medicine (deaton and cartwright ) specifically mentioned the use of ai as a potential solution to some of the problems of using average treatment effects (ates). kessler et al. ( a) noted that clinical trials do not tell us which treatments are more effective for which patients. they suggested that what they label as precision treatment rules (ptrs) be developed that are predictors of the relative treatment effectiveness of different treatments. the authors presented a comprehensive discussion on how to use ml to develop ptrs. they concluded that the sample sizes needed are much larger than usually those found in rcts; observational data, especially from electronic medical records (emrs) can be used to deal with the sample size issue; and statistical methods can be used to balance both observed and unobserved covariates using instrumental variables and discontinuity designs. they do note the difficulty in obtaining full baseline data from emrs and suggest several solutions for this problem, including supplemental data collection and links to other archival sources. they recommend the use of an ensemble ml approach that combines several algorithms. they are clear that their suggestions are exploratory and require verification, but they are more certain that if ml improves patient outcomes, it will be a substantial improvement. wu et al. ( ) collaborated with kessler on a proof of concept of a similar model called individualized treatment rules (itr). in a model simulation, they used a large sample (n = , ) with an ensemble ml method to identify the advantages of using ml algorithms to estimate the outcomes if a precision medicine approach was taken in prescribing medication for persons with first-onset schizophrenia. they found that the treatment success was estimated to be . % under itr compared to . % with the medication that was actually used. wu et al. see this as a first step that needs to be confirmed by pragmatic rcts. kessler et al. ( b) conducted a relatively small randomized study (n = ) in which soldiers seeking treatment were judged to be at risk for suicide. they were randomly assigned to two types of treatment but not on the basis of any a priori ptr. the data from that study were then analyzed using ml to produce ptrs. these data were then modeled in a simulation to see if the ptr would have produced better outcomes. the authors did find that the simulated ptr produced better effects. lenze et al. ( ) address the problems of rcts from a somewhat different perspective than i have presented here and suggest a potential solution that they call precision clinical trials (pcts). the authors propose that the problem with most existing rcts is that they measure only the fixed baseline characteristics that are not usually sensitive to detecting treatment responders. moreover, treatment is typically not dynamically adapting to the client during treatment, and measures are not administered with sufficient frequency. instead, the pcts would: ( ) first attempt to determine whether short-term responses to the intervention could determine who was a likely candidate for that specific treatment; ( ) initiate the treatment in an adaptive fashion that could vary over time, using stepped care or just-in-time adaptations that are responsive to the client's changing status, and frequently collect data possibly using multiple assignment randomized trial methods; and ( ) use frequent precision measurement, possibly using ecological momentary assessments described earlier. coincidently, they illustrate the application of pcts using repetitive transcranial magnetic stimulation (rtms), a form of brain stimulation therapy used to treat depression and anxiety that has been in use since . rtms will be described later in connection with what i call a third path for services and ai. it is disappointing that i could not find any examples of published research that used a rct to test whether an ai approach to an actual, not simulated, delivery of a mental health treatment produces better clinical outcomes than a competitive treatment or even treatment as usual. this is clearly an area requiring further rigorous empirical investigation. imel et al. ( ) provide an excellent overview on how ai and other technologies can be used for monitoring and feedback in psychotherapy in both training and supervision. imel et al. ( ) used ml to code and provide data to clinicians on metrics used to measure the quality of motivational interviewing (mi). a prior study (tanana et al. ) established that ml was able to code mi quality metrics with accuracy similar to human coders. they conducted a pilot study using standardized patients and -min speech segments that was designed to test the feasibility of providing feedback to clinicians on the quality of their mi intervention. the feedback was not in real-time but was provided after the session. they were able to establish that clinicians thought highly of the feedback they received. the authors anticipate that further developments in this technology will lead to its widespread use in supervision and in real-time feedback. it would seem that the next step is evaluating the enhanced ai feedback procedure in a real-world effectiveness study. another example of the use of nlp application is the use of a bot that was trained to assess and provide feedback on specific interviewing and counseling skills such as asking open-ended questions and providing feedback (tanana et al. ) . after training the bot on transcripts, non-therapists (using amazon mechanical turk recruits) were randomly assigned to either immediate feedback on a practice session with the bot or just encouragement on the use of those skills. the group provided the feedback were significantly more likely to use reflection even when feedback was removed. the authors consider this to be a proof of concept demonstration because of the many limitations (e.g., use of non-therapists). a plan for using nlp to monitor and provide feedback to clinicians on the implementation of an evidenced program is provided by berkel et al. ( ) . they provide excellent justification for using nlp to accomplish this goal, but unfortunately it is only a design at this point. rosenfeld et al. ( ) see ai making major contributions to improving the quality of treatment through efficient continuous monitoring of patients. until now, monitoring was limited to in-session contacts or manual contacts, an approach that is not practical or efficient. the almost universal availability of smartphones and other internet active devices (internet of things) makes collecting data from clients practical and efficient. these various data sources provide feedback to providers so that they can predict and prevent relapse and compliance with treatment, especially medication. the authors note that there is not a large body of research in this area, but early studies are positive. one concrete application of ai to providing feedback is described by ryan and his colleagues . their article only describes how such could be done; unfortunately, it is not an actual study but a suggestion on how to apply ai for feedback to physicians to improve their communications with patients. they note that routine assessment and feedback are not done manually because of the cost and time requirements. however, ai can automate these tasks by evaluating recordings. they suggest using already existing ai approaches that are in use by call centers to categorize and evaluate communication along the following dimensions: speaker ratio that indicates listening, overlapping talk that are interruptions, pauses longer than two seconds, speed, pitch, and tone. the content could also be evaluated along the dimensions of the use of plain language, clinical jargon, and shared decision making. ai could also explore other dimensions such as the meaning of words and phrases using nlp, turn taking, tone, and style. many technical difficulties would have to be overcome to assess many of these variables, but the field is making progress. an actual application of ml to feedback, but not in mental health, is provided by pardo et al. ( ) in a course for first-year engineering students. instructors developed in advance a set of feedback messages for levels of interaction with learning resources. for example, different feedback messages were provided depending on whether the student barely looked at video, watched a major portion, watched the whole video, or watched it several times. an ml algorithm selected the appropriate message to send the student through either email or the virtual learning environment. compared to earlier cohorts who did not receive the feedback, those who did were more satisfied with the course and had better performance on the midterm. i can see how such a protocol could be used in mental health services. an indication of the work that needs to be done in becoming more specific about feedback is a study conducted by hooke et al. ( ) . they provide feedback to patients with and without a trajectory showing expected progress and found that patients preferred the feedback with the expected change over time. they found that these patients preferred to have normative feedback with which they could compare their own ideographic progress. two systematic reviews that focused on implementing routine outcome measurement (rom) concluded that while rom has been shown to produce positive results, how to best implement rom remains to be determined by future research (gual-montolio et al. ; mackrill and sorensen ) . the authors of both reviews note several interesting points but focus on these two: how to integrate measurement into clinical practice and how organizations support staff in this effort. they highlight the importance of developing a culture of feedback in organizations. neither review includes any studies using ai. while they call for more research to move this field forward, i do not think there will be much change until either measurement feedback systems are required by funders or service delivery organizations are paid for providing such systems. probably the most advanced work in this area that includes ml is being done by lutz and his colleagues (lutz et al. ) . they have developed a measurement feedback system that includes the use of ml to make predictions and to provide clinicians with clinical decision support tools. they are able to predict dropouts and assign support tools to clinicians that are specific to the problems their clients are exhibiting, based on the data they have collected. lutz and his colleagues are currently evaluating the system to influence clinical outcomes in a prospective study. this comprehensive feedback system provided clinical support tools with recommendations based on identification of similar patients to the treatment group but not to the control group. they already have some very promising results using three different treatment strategies (w. lutz, personal communication, september , ) . almost all the research in this area has been on prediction and not in actually testing whether precision treatments are in fact better than standard treatments in improving mental health outcomes. even these predictive studies are on extant databases rather than data collected specially for use in ai algorithms. with a few exceptions to be discussed later, this is the state of the art. to establish the practical usefulness of ai, we need to move beyond prediction to show actual mental health improvements that have clinical and not just statistical significance. there are some scholars who are carefully considering how to improve methodology to achieve better predictions (e.g., garb and wood ) . in addition, zilcha-mano ( ) has a very thoughtful paper that describes traditional statistical and machine learning approaches to trying to answer the core question of what treatments work best for which patients, as well as the more general question about why psychotherapy works at all. nlp has been used to analyze unstructured or textual material for identifying suicidal ideation in a psychiatric research database. precision of % for identification of suicide ideation and % for suicide attempts has been found using nlp (fernandes et al. ) . a meta-analysis of studies of prediction of suicide using traditional methodologies found only slightly better than chance predictions and no improvement in accuracy in years (franklin et al. b ). recent ml decision support aids using large-scale biological and other data have been useful in predicting responses to different drugs for depression (dwyer et al. ). triantafyllidis and tsanas ( ) conducted a literature review of pragmatic evaluations of nonpharmacological applications of ml in real-life health interventions from january through november , following prisma guidelines. they found only eight articles that met their criteria from citations screened. three dealt with depression and the remainder with other health conditions. six of the eight produced significantly positive results, but only three were rcts. there has been little rigorous research to support ai in real-world contexts. accuracy of prediction is one of the putative advantages of ai. but the advantage of predicting outcomes is not as relevant if a client prematurely leaves treatment. thus, predicting premature termination is one of the key goals of an ai approach. in a pilot study to test whether ai could be beneficial in predicting premature termination, bohus et al. ( ) were not able to adequately predict dropouts using different ml approaches with responses to the borderline symptom list (bsl- ). however, they obtained some success when they combined the questionnaire data with personal diary questionnaires from patients, although they note that the sample is too small to draw any strong conclusions. this pilot study illustrates the importance of what data goes into the data set as well as our lack of knowledge of the data requirements we need to have confidence in as we select the appropriate data. duwe and kim ( ) compared statistical methods including ml approaches on their accuracy in predicting recidivism among , offenders. they found the newer ml algorithms generally performing modestly better. kessler et al. ( ) used data from u.s. army and department of defense administrative data systems to predict suicides of soldiers who were hospitalized for a psychiatric disorder (n = , ). within one year of hospitalization, ( . %) of the soldiers committed suicide. they used a statistical prediction rule based on ml that resulted in a high validity auc value of . . kessler and his colleagues have continued this important work, which was discussed earlier. another approach to prediction was taken by pearson et al. ( ) in predicting depression symptoms after an -week internet depression reduction program using participants. they used an elastic net and random forest ml ensemble (combination) and compared it to a simple linear autoregressive model. they found that the ensemble method predicted an additional % of the variance over the non-ml approach. the authors offer several good technical suggestions about how to avoid some common errors in using ml. moreover, the ml approach allowed them to identify specific module dosages that were related to outcomes that would be more difficult to determine using standard statistical approaches (e.g., detecting nonlinear relationships without having to specify them in advance). however, not all attempts to use ai are successful. pelham et al. ( ) compared logistic regression and five different ml approaches to typical sum-score approaches to identify boys in the fifth grade who would be repeatedly arrested. ml performed no better than simple logistic regression when appropriate cross-validation procedures were applied. the authors emphasize the importance of cross-validation in testing ml approaches. in contrast, a predictive study of people with first-episode psychosis used ai to successfully predict poor remission and recovery one year later based only on baseline data (leighton et al. ) . the model was cross validated on two independent samples. a comprehensive synthesis of the literature of studies that used ml or big data to address a mental health problem illustrated the wide variety of uses that currently exist; however, most dealt with detection and diagnosis (shatte et al. ) . a critical view of the way psychiatry is practiced for the treatment of depression and how ai can improve that practice is provided by tan et al. ( ) . they note that most depression is treated with an "educated-guess-and-check approach in which clinicians prescribe one of the numerous approved therapies for depression in a stepwise manner" (p. ). they posit that ai and especially deep learning have the ability to model the heterogeneity of outcomes and complexity of psychiatric disorders through the use large data sets. at this point, the authors have not provided any completed studies that have used ai, but two of the authors are shareholders in a medical technology company that is developing applications using deep learning in psychiatry. we are beginning to see commercial startups take an interest in mental health services even though the general health market is considerably bigger. entrepreneurially motivated research may be important for the future of ai growth in mental health services, with traditional federal research grants to support this important developmental work, including such mechanisms as the small business innovation research (sbir) program and the r and r nih funding mechanisms. one of the few studies that go beyond just prediction and actually attempt to develop a personalized treatment was conducted by fisher et al. ( ) . in a proof of concept study, the authors used fisher's modular model of cognitive-behavioral therapy (cbt) and algorithms to develop and implement person-by-person treatments for anxiety and mood disorders for adults. the participants were asked to complete surveys four times a day for about days. the average improvement was better than found in comparison benchmark studies. the authors state that this is the first study to use pre-therapy multivariate time series data to generate prospective treatment plans. rosenfeld et al. ( ) describe several treatment delivery approaches that utilize ai. woebot, for example, is a commercial product to provide cbt-based treatment using ai. the clients interact with woebot through instant messaging that is later reviewed by a psychologist. it has been shown to have short-term effectiveness in reducing phq- scores of college students who reported depression and anxiety symptoms. the authors are optimistic that approaches like the ones described will lead to more widely available and efficacious treatment modalities. applications of ml to addiction studies was the focus of a systematic review by mak et al. ( ) . they did an extensive search of the literature until december and could find only articles. none of the studies involved evaluating a treatment. i want to distinguish between the use of computer-assisted therapy, especially that provided through mobile apps, and the use of ai. in a review of these digital approaches to providing cbt for depression and anxiety, wright et al. ( ) point out while many of these apps have been shown to be better than no treatment, they usually do not use ai to personalize them. thus, they are less relevant to this paper and are not discussed in depth. ecological momentary interventions (emis) are treatments provided to patients between sessions during their everyday lives (i.e., in real time) and in natural settings ). these interventions extend some aspects of psychotherapy to patients' daily lives to encourage activities and skill building in diverse conditions. in the only systematic review available of emis, colombo et al. ( ) found only eight studies that used emis to treat major depression, with only four different interventions. the common factor of these four interventions is that they provide treatment in real-time and are not dependent on planned sessions with a clinician. the authors report that participants were generally satisfied with the interventions, but there was variability in compliance and dropout rates among the programs. with only two studies that tested for effectiveness with rcts, there is clearly a need for more rigorous evaluations. momentary reminders are typically used for behaviors such as medication adherence and management of symptoms. the more complex emis use algorithms to optimize and personalize systems. they also can use algorithms that changes the likelihood of the presentation of a particular intervention over time, based on past proximal outcomes. schueller et al. ( ) note that emis are becoming more popular as a result of technological advances. these authors suggest the use of micro-randomized trials (mrts) to evaluate them. an mrt uses a sequential factorial design that randomly assigns an intervention component to each person at multiple randomly chosen times. each person is thus randomized many times. this complex design represents the dynamic nature of these interventions and how their outcomes correspond to different contextual features. ai is often used to develop algorithms to optimize and personalize the mrt over time. one interesting algorithm, called a "bandit algorithm," changes the intervention presented based on a past proximal outcome. as an example, schueller et al. describe a hypothetical study to reduce anxiety through two different techniques-deep breathing and progressive muscle relaxation. the bandit algorithm may start the presentation of each technique with equal frequency but then shift more to the one that appears to be most successful for that individual. thus, each treatment (a combination of deep breathing and progressive muscle relaxation) would be different for each person. unlike rcts, this method does not use group-level outcomes of average effect sizes but uses individual-level data. in the future, we might have personal digital mental health "therapists" or assistants that can deliver individualized combinations of treatments based on algorithms developed with ai that are data driven. of course, this approach is best suited for these momentary interventions and would be difficult if not impossible to successfully apply to traditional treatment. i consider explicating the relationship between ai and causality to be a key factor in understanding whether ai is to be seen as replacing or as supplementing rcts. toward that end, i first consider whether observational data can replace rcts using ai. second, should a replacement not seem currently feasible, i explore ways to design studies that combine ai and rcts to evaluate whether the ai approach produces better outcomes than non-ai enhanced interventions. the journal prevention science devoted a special section of an issue to new approaches for making causal inferences from observational data (wiedermann et al. ). an example is the paper by shimizu ( ) that demonstrates the use of non-gaussian analysis tools to infer causation from observational data under certain assumptions. malinsky and danks ( ) provide an extended discussion of the use of causal discovery algorithms to learn causal structure from observational data. in a similar fashion, blöbaum et al. ( ) present a case for inferring causal direction between two variables by comparing the least-squares errors of prediction in both possible directions. using data that meet some assumptions, they provide an algorithm that requires only a regression in both causal directions and a comparison of the least-square errors. lechner's ( ) paper focuses on identifying the heterogeneity of treatment effects at the finest possible level or identifying what he calls groups of winners and losers who receive some treatment. hassani et al. ( ) hope to build a connection between researchers who use big data analysis and data mining techniques and those who are interested in causality analysis. they provide a guide that describes data mining applications in causality analysis. these include entity extractions, cluster analysis, association rule, and classification techniques. the authors also provide references to studies that use these techniques, key software, substantive areas in which they have been used, and the purpose of the applications. this is another bit of evidence that the issue of causality is being taken seriously and that some progress is being made. however, because of the newness of these publications, there is a lag in publications that are critical of these approaches; for example, d'amour ( ) provides a technical discussion about why some approaches will not work but also suggests that others may be potentially effective. clearly, caution is still warranted in drawing causal conclusion from observational data. chen ( ) provides a very interesting discussion of ai and causality but not from the perspective of the rct issue that i raise here but as a much broader but still relevant point of view. he advances the key question about whether ai technology should be adopted in the medical field. chen argues that there are two major deficits in ai, namely the causality deficit and the care deficit. the causality deficit refers to the inferior ability of ai to make accurate casual inferences, such as diagnosis, compared to humans. the care deficit is the comparative lack of ability of ai to care for a patient. both deficits are interesting, but the one most germane to this paper is the causality deficit. chen notes that ai represents statistical and not causal reasoning machines. he argues that ai is deficient compared to humans in causal reasoning, and, moreover, he doubts that there is a feasible way to deal with this lack of comparability in reasoning. he believes that ai is a model-blind approach in contrast to a human's more model-based approach to causal reasoning. thus, causation for chen is not an issue of experimental methodology (he never mentions rcts in his paper), but a characteristic associated with humans and not computers. chen does recognize that ai researchers are attempting to deal with the causality issue, for example, by briefly describing pearl's ( ) directed acyclic graphs and nonparametric structural equation models. but chen is skeptical that either the causality or care deficits will be overcome. he concludes that ai is best thought of as assisting humans in medical care and not replacing them. the relationship between ai and humans is a major concern of this paper. caliebe et al. ( ) see big data, and i would assume ai, as contributing to hypotheses generation that could then be tested in rcts. the critical issues they see are related to the quality and quantity of big data. they quote an institute of medicine (iom) report that refers to the use of big data and ai in medicine as "learning healthcare systems" and states that these systems will "transform the way evidence on clinical effectiveness is generated and used to improve health and health care" (institute of medicine , p. ). moreover, in , the iom suggested that alternative research methodologies will be needed. they do not acknowledge the conundrum that i have raised here; moreover, they do not see any need to consider changing any of our methodology or analyses. i have found many individual papers that describe how to solve the causality problem with ai (e.g., kuang et al. ; pearl ) . although these papers are complex, their mere existence gives me hope that this problem is being seriously considered. in addition to the statistical and validity issues in trying to replace rcts with observational data, there is the feasibility question. although the data studied in much of the research reported in this paper are in the medical domain and deal primarily with medications, the characteristics of these data have some important lessons for mental health services. bartlett et al. ( ) identified trials published in the top seven highest impact medical journals. they then determined whether the intervention, medical condition, inclusion and exclusion criteria, and primary end points could be routinely obtained from insurance claims and/or electronic health data (ehr) data. these data are recognized by the fda as what they term real-world evidence. they found that only % of the u.s.-based clinical trials published in highimpact journals in could be feasibly replicated through analysis of administrative claims or ehr data. the results suggest that potential for real-world evidence to replace clinical trials is very limited. at best, we can hope that they can complement trials. given the paucity of data collected in mental health settings, the odds are that such data are even less available. suggestions for improving the utility of real-world data for use in research are provided in an earlier article by some of these authors (dhruva et al. ). pearl ( ) posits causal information in terms of the types of questions that, in his three-level model, each level answers. his first level is association; the second, intervention; and the third, counterfactual. association is simply the statistical relationship or correlation. there is no causal information at this first level. the higher order levels can answer questions about the lower levels but not the other way around. counterfactuals are the control groups in rcts. they represent what would have happened if there had been no intervention. to pearl, this unidirectional hierarchy explains why ml, based on associations, cannot provide causal statements like rcts, which are based on counterfactuals. however, as noted earlier, pearl does present an approach using what he calls structural causal models to "extract" causal relationships from associations. pearl describes seven "talks" and accompanying tools that are accomplished in the framework provided by the structural causal models that are necessary to move from the lower levels to the counterfactual level to allow causal inferences. i would anticipate that there will be direct comparisons between this approach to causality and the randomized experiments like those done in program evaluation (bickman and reich ; boruch et al. ) . theory development or testing is usually not thought of as a strength of ai; instead, its lack of transparency, that is, the lack of explanatory power that would enable us to identify models/mechanisms that underlie outcomes, is seen as a major weakness. coutanche and hallion ( ) present a case for using feature ablation to test theories. this technique involves the removal or ablation of features from algorithms that have been thought to be theoretically meaningful and then seeing if there is a significant reduction in the predictive accuracy of the model. they have also studied whether the use of a different data set affects the predictive accuracy of a previously tested model in theoretically useful ways. they present a very useful hypothetical application of their approach to test theories using ai. it is clear that ai can be very useful in making predictions, but can it replace rcts? can ai perform the major function of rcts, that of determining causality? the dependence on rcts was one of the major limitations i saw as hindering the progress of mental health services research. while rcts have their flaws, they are still considered by most as the best method for determining causal relationships. is ai limited to being a precursor in identifying those variables that are good candidates for rcts because they have high predictive values? the core conceptual problem is that while it is possible to compare two different but theoretically equivalent groups, one receiving the experimental treatment and the other the control condition, it is not possible to compare the same individuals on both receiving and not receiving the experimental treatment. rcts produce average effect sizes, but the ultimate purpose of precision mental health is to predict individualized effects. how do we reconcile these two very different aims? one approach is to use ai to identify the most predictive variables and then test them in a randomized experiment. let us take a group of patients with the same disorder or problem. there may be several alternative treatments, but the most basic concept is to compare two conditions. in one condition, call it the traditional treatment condition in the rct, everyone in that condition gets the same treatment. it is not individualized. in the second condition, call it the ai condition, everyone gets a treatment that is based on prior ai research. the latter may differ among individuals in dosage, timing, type of treatment, and so on. the simplest is medication that differs in dosage. however, a more nuanced design is a yoked design used primarily in operant and classical conditioning research. there have been limitations associated with this design, but these problems apply to conditioning research and not the application considered here (church ) . to separate the effects of the individualization from the differences in treatment, i suggest using a yoked design. in this design, individuals who would be eligible to be treated with either the standard treatment or the ai-selected treatment would be yoked, that is, paired. which participant of the pair received which condition would be randomized. first, the eligible participants would be randomly divided into two groups. the individuals in the ai group would get a treatment that was precisely designed for each person in that group, while those in the yoked control group would not; instead, those in the control group would receive the treatment that had been designed for his or her partner in the ai group. in this way, each participant would receive the same treatment, but only the ai group participants would be receiving individualized treatment. if the ai approach is superior, we would expect those in the ai group to have a superior average treatment effect compared to the control group, who received a treatment matched not to their individual characteristics but to those in the ai group. we could also use an additional control group where the treatment is selected by a clinician. while this design would not easily identify which characteristics were responsible for its success, it would demonstrate whether individualized ai-based treatment was the causal factor. that is, we could learn that on the average, a precision approach is more effective than a traditional approach, but we would not be able to identify from this rct which particular combination of characteristics made it more effective. of note is that the statistical power of this design would depend on the differences among the participants at baseline. for example, if the individuals were identical on measured covariates, then they would get the same personalized treatment, which practically would produce no useful information. instead of yoking participants based on randomly assigning them as in the above example, we could yoke them on dissimilarity and then randomly assign each individual in the pair to ai-based treatment or a control condition that could be the same ai treatment or a clinician-assigned treatment. however, interesting this would be from a methodical point of view, i think this would also bring up ethical issues that are discussed next. of course, as with any rct, there are ethical issues to consider. in many rcts, the control group may receive standard treatment, which should not present any unusual ethical issues. however, in a yoked design, the control group participants will receive a treatment that was not selected for them on the basis of their characteristics. moreover, the yoked design would make the formulation of the informed consent document problematic because it would have to indicate that participants in the control group would receive a treatment designed for someone else. one principle that should be kept in mind is equipoise: there should be consensus among clinicians and researchers that the treatments, a priori, are equivalent. in a yoked design, we must be assured that none of individualized treatments would harm the yoked control group members, and moreover, that there is no uniform agreement that the individualized treatment would be better for the recipient. that is, the research is designed to answer a question about relative effectiveness for which we do not know the answer. almost all of the research previously cited in this paper has dealt with psychosocial interventions, along with some research on interventions with medications. clearly these are the two main approaches taken in providing services for mental health problems. however, in the last decade, a new approach to understanding mental illness has emerged from the field of psychoneuroimmunology. this relatively new field integrates research on psychology, neuroscience, and immunology to understand how these processes influence each other and, in turn, human health and behavior (slavich ). i want to explore this relatively new approach to understanding mental health because i believe that it is a potentially rich field in which to apply ai. slavich and irwin ( ) have combined diverse areas to show how stressors affect neural, physiologic, molecular, and genomic and epigenetic processes that mediate depression. they labeled this integrative theory the social signal transduction theory of depression. in a recent extension of this work, slavich ( ) proposed social safety theory, which describes how social-environmental stressors that degrade experiences of social safety-such as social isolation and rejection-affect neural, immunologic, and genomic processes that increase inflammation and damage health. a key aspect of this perspective is the role of inflammatory cytokines as key mediators of the inflammatory response (slavich ) . cytokines are the biological endpoint of immune system activity and are typically measured in biobehavioral studies of stress and health. cytokines promote the production of c-reactive protein, which is an inflammatory mediator like cytokines, but which also is a biomarker of inflammation that is assessed with a blood test. cytokines also interact with the central nervous system and produce what have been labeled "sickness behaviors," which include increased pain and threat sensitivity, anhedonia, fatigue, and social-behavioral withdrawal. while the relationship between inflammation and depression is well-established in adults, a systematic review and meta-analysis of studies with children and adolescents concluded that because of the small number of studies, more evidence was needed before drawing a similar conclusion for youth (d'acunto et al. ) . in contrast, a major longitudinal study of more than adults followed over years found that participants who had stable high c-reactive protein levels were more likely to report clinically significant late-life depression symptoms (sonsin-diaz et al. ) . chronic inflammation has been shown to be present in many psychiatric disorders including depression, schizophrenia, and ptsd, as well as in many other somatic and physical disease conditions (furman et al. ) . chronic inflammatory diseases have been shown to be a major cause of death. a typical inflammatory response occurs when a threat is present and then goes away when there is no longer a threat. however, when the threat is chronic and unresolved, systemic chronic inflammation can occur and is distinct from acute inflammation. chronic inflammation can cause significant damage to tissues and organs and break down the immune system tolerance. what is especially interesting from a behavioral health perspective is that inflammatory activity can apparently be initiated by any psychological stressor, real or imagined. thus, social and psychological stressors such as negative interpersonal relationships with friends and family, as well as physical stressors, can produce inflammation, which leads to increased risk of mental and physical health problems. this inflammatory response initially can have positive effects in that it can help increase survival in the short term, but it can also lead to a dysfunctional hypervigilance and anxiety that increases the risk of serious mental illness if chronic. the "cytokine storm" experienced by many covid- patients is an example of the damage an uncontrolled immune response can cause (konig et al. ). although we do not know a great deal about how this process operates, it is clear that there is a strong linkage between inflammatory responses and mental disorders such as depression. the role of the immune system in disease, especially brain inflammation related to brain microglial cells (i.e., neuroinflammation), is also receiving attention in the popular press (nakazawa ). psychoneuroimmunology research has explicated the linkage between the brain and the immune system, showing how stress affects the immune system, and how these interactions relate to mental illness. the relationships between these constructs suggest interventions that can be used to improve mental health. but much research remains to be done to identify specific processes and effective interventions. research will require multidisciplinary teams to produce personalized interventions guided by each patient's specific level of neuroinflammation and genetic profiles. this process will need to be monitored by continuous feedback that i believe will be made more feasible with the application of ai. at present, there are some existing interventions that appear to be aligned with this approach that are being explored. these include the following. three anti-inflammatory medications have been found to reduce depressive symptoms in well-designed rcts. these agents include celecoxib, usually used for treating excessive inflammation and pain, and etanercept and infliximab, which are used to treat rheumatoid arthritis, psoriasis, and other inflammatory conditions (slavich ) . however, there has not been a great deal of research in this area, so caution is warranted. a recent well-designed rct with depressed youth tested aspirin, rosuvastatin (a statin), and a placebo and found no significant differences in depression symptoms (berk et al. ). a meta-analysis explored the possible link between different types of psychosocial interventions, such as behavior therapy and cbt, and immune system function (shields et al. ) . the authors examined eight common psychosocial interventions, seven immune outcomes, and nine moderating factors in evaluating rcts. they found that psychosocial interventions were associated with a . % improvement in good immune system function and a . % decrease in detrimental immune function, on average. moreover, the effects lasted for at least months and were consistent across age, sex, and intervention duration. the authors concluded that psychosocial interventions are a feasible approach for influencing the immune system. repetitive transcranial magnetic stimulation (rtms) has been found to be an effective treatment for several mental illnesses, especially treatment-resistant depression (mutz et al. ; somani and kar ; voigt et al. ) . while the literature is not clear on how rtms produces its effect (noda et al. ; peng et al. ) , i was curious about its relationship to neuroinflammation. i could find little in the research literature that addressed the relationship between inflammation and rtms; therefore, i conducted an informal survey of rtms researchers who have published rtms research in peer-reviewed journals and asked them the following: i suspect that rtms is related to inflammation but the only published research that i could find on that relationship was two studies dealing with rats. are you aware of any other research on this relationship? in addition, do you know of anyone using ai to investigate rtms? i received replies from all but of the researchers. about half said they were aware of some research that linked rtms to inflammation and supplied citations. in contrast, only % were aware of any research on rtms and ai. the latter noted some research that used ai on eegs to predict rtms outcomes. a most informative response was from the author of a review article that dealt with several different nontraditional treatments including rtms on the hypothalamic-pituitary-adrenal (hpa) axis and immune function in the form of cytokine production in depression (perrin and parianti ) . the authors found relevant human studies ( studies using rtms) but were unable to conduct the metaanalysis because of significant methodological variability among studies. but they concluded that non-convulsive neurostimulation has the potential to impact abnormal endocrine and immune signaling in depression. moreover, given that there is more information available than on other neurostimulation techniques, the research suggests that rtms appears to reduce cytokines. finally, there is some support from animal models (rats) that rtms can have an anti-inflammatory effect on the brain and reduce depression and anxiety (tiana et al. ). moreover, four published studies showed that the efficacy of rtms for schizophrenics could be predicted koutsouleris et al. ( b) . three other studies were able to use ml and eeg to predict outcomes of rtms treatment for depression (bailey et al. ; hasanzadeh et al. ) . the existing literature indicates that metabolic activity and regional cerebral blood flow at the baseline can predict the response to rtms in depression (kar ) . as these baseline parameters are linked to inflammation, it is worth studying responses to rtms that predict inflammation. as noted by one of the respondents, "in summary, it is a relatively new field and there are no major multi-site machine learning studies in rtms response prediction" (n. koutsouleris, personal communication, march , ) . one of the significant limitations of measurement in mental health is the absence of robust biomarkers of inflammation. furman et al. ( ) caution us that "despite evidence linking sci [systemic chronic inflammation] with disease risk and mortality, there are presently no standard biomarkers for indicating the presence of health-damaging chronic inflammation" (p. ). however, some biomarkers that are currently being explored for inflammation may be of some help. for example, furman et al. ( ) are hopeful that a new approach using large numbers of inflammatory markers to identify predictors will produce useful information. a narrative review of inflammatory biomarkers for mood disorders was also cautious in drawing any conclusions from extant research because of "substantial complexities" (chang and chen ) . it is also worth noting the emerging area of research on gut-brain communication and the relationship between microbiome bacteria and quality of life and mental health (valles-colomer et al. ) . however, there is need for more research on the use of biomarkers. the area of inflammation and mental health offers an additional pathway to uncovering the causes of mental illness but also, most importantly for this paper, potential services interventions beyond traditional medications and psychosocial interventions. given the complexity, large number of variables from diverse data sets, and the emerging nature of this area, it appears that ai could be of great benefit in tying some potential biomarkers to effective interventions designed to produce better clinical outcomes. however, some caution is needed concerning the seemingly "hard data" provided by biomarkers. for example, elliot et al. ( ) found in a meta-analysis of experiments that one widely used biomarker, task-fmir, had poor overall reliability and poor test-retest reliability in two other large studies. they concluded that these measures were not suitable for brain biomarker research or research on individual differences. as noted in several places in this paper, ai is not without its problems and limitations. the next section of the paper discuses several of these problems. ai may force the treatment developer to make explicit choices that are ethically ambiguous. for example, automobile manufacturers designing fully autonomous driving capabilities now have to be explicit about whose lives to value more in avoiding a collision-the driver and his or her passengers or a pedestrian. should the car be programmed to avoid hitting a pedestrian, regardless of the circumstances, even if it results in the death of the driver? mental health services do not typically have such clear-cut conflicts, but the need to weigh the potential side effects of a drug against potential benefits suggests that ethical issues will confront uses of ai in mental health. some research has shown that inherent bias in original data sets has produced biased (racist) decisions (obermeyer et al. ; veale and binns ) . an unresolved question is who has the responsibility for determining the accuracy and quality of original data set (packin and lev-aretz ) . data scientists operating with data provided by others may not have sufficient understanding of the complexity of the data to be sensitive to its limitations. moreover, they may not consider it their responsibility to evaluate the accuracy of the data and attend to its limitations. librenza-garcia ( ) provides a comprehensive review of ethical issues in the use of large data sets with ai. the ethical issues in predicting major mental illness are discussed by lawrie et al. ( ) . they note that predictive algorithms are not sufficiently accurate at present, but they are progressing. the authors raise questions about whether people want to know their risk level for major psychiatric disorders, about individual and societal attitudes to such knowledge and the possible adverse effects of sharing such data, and about the possible impact of such information on early diagnosis and treatment. they urge conducting research in this area. related to the ethics issue but with more direct consequences to the health provider is the issue of legal responsibility in using an ai application. it is not clear what the legal liability is for interventions based on ai that go wrong. who is responsible for such outcomes-the person applying the ai, the developer of the algorithm, or both? price ( ) points out that providers typically do not have to be concerned about the legal liability of a negative outcome if they used standard care. thus, if there are negative outcomes of some treatment but that treatment was the standard of care, there is usually no legal liability. however, currently ai is probably not seen as the standard of care in most situations. while this will hopefully change as evidence of the effectiveness of ai applications develops, currently the healthcare provider is at greater risk of legal liability in using an ai application that is different from the standard of care. i have previously discussed the insufficient evidence for the effectiveness of many of the interventions used in mental health services. this lack of strong evidence has implications for the use of ai in mental health services. in an insightful article on using ai for individual-level treatment predictions, paulus and thompson ( ) make several key observations and suggestions that are very relevant to the current paper. the authors summarize several meta-analyses of the weak evidence of effectiveness of mental health interventions and come to conclusions similar to those i have already stated. they also identify similar factors i have focused on in accounting for the modest effect sizes found in mental health rcts. they point out that diagnostic categories are not useful if they are not aggregating homogenous populations. they suggest that what i call the diagnostic muddle may result from the nature of mental disorders themselves, for which there are many causes at many different levels, from the genetic to the environmental. thus, there is no simple explanatory model. paulus and thompson note that prediction studies rarely account for more than a very small percentage of the variance. they recommend conducting large, multisite pragmatic rcts that are clearly pre-defined with specific ml models and variables. predictive models generated by this research then need to be validated with independent samples. this is a demanding agenda, but i think it is necessary if we are going to advance mental health services with the help of ai. treatments are often considered black boxes that provide no understanding of how and why the treatment works (kelley et al. ; bickman b) . the problem of lack of transparency is compounded in the use of deep neural networks (samek et al. ) . at present we are not able to understand relationships between inputs and outcomes, because this ai technique does not adequately describe process. deep neural networks may contain many hidden layers and millions of parameters (de choudhury and kikkoman ). however, this problem is now being widely discussed, and new technologies are being developed to make ai more transparent (rauber et al. ; kuang et al. ). i do not believe it is possible to develop good theories of treatment effectiveness without this transparency. this is an important limitation of efforts to improve mental health services. but how important is this limitation? early in my program evaluation career, i wrote about the importance of program theory (bickman (bickman , . i argued that if individual studies were going to be conceptually useful, beyond local decisions such as program termination, then they must contribute to the broader goal of explaining why certain programs were effective and others not. this is in contrast to the worth and merit of a local program. a theory based evaluation of the program must add to our understanding of the theory underlying the program. while i still believe that generalizing to a broad theory of why certain interventions work is critical, at present it may be sufficient simply to increase the accuracy of our predictions, regardless of whether we understand why. as stephens-davidowitz ( ) argues, "in the prediction business, you just need to know that something works, not why" (p. ). however, turing award winner judea pearl argued in his paper theoretical impediments to machine learning with seven sparks from the causal revolution ( ) that human-level ai cannot emerge from model-blind learning machines that ignore causal relationships. one of the positive outcomes of the concern over transparency is the development of a subfield of ai that has been called explainable artificial intelligence (xai). adai and berrada ( ) present a very readable description of this movement and show that it has been a growing area since . they are optimistic that research in this area will go a long way toward solving the black box problem. large data sets are required for some ai techniques, especially deep neural networks. while such data sets may be common in consumer behavior, social media, and hospitalbased electronic health records, they are not common in community-based mental health services. the development and ownership of these data sets may be more important (and profitable) than ownership of specific ai applications. there is currently much turmoil over data ownership (mittelstadt ) . ownership issues are especially important in the mental health field given the sensitivity of the data. in addition to the size and quality of the data set, longitudinal data are necessary for prediction. collecting longitudinal data poses a particular problem for community-based services given the large treatment drop-out rate. in addition to the characteristics of the data, there is the need for competent data managers of large complex data sets. the data requirements for mental health applications are more demanding than those for health in general. first, mental health studies usually do not involve the large samples that are found in general health. for example, the wellknown physicians' health study of aspirin to prevent myocardial infarction (mi) utilized more than , doctors in a rct (steering committee of the physicians' health study research group ). they found a reduction in mi that was highly statistically significant: p < . . the trial was stopped because it was thought that this was conclusive evidence that aspirin should be adopted for general prevention. however, the effect size was extremely small: a risk difference of . % with r = . (sullivan and feinn ) . a study this size is not likely to occur in mental health. moreover, such small effects would not be considered important even if they could be detected. it is unlikely that very large clinical trials such as the aspirin study would ever be conducted in mental health. thus, it is probable that data will have to be obtained from service data. but mental health services usually do not collect sufficiently fine-grained data from clients. while i was an early and strong proponent of what i called a measurement feedback system for services (bickman a) , recent research shows that the collection of such data is rare in the real world. until services start collecting these data as part of their routine services, it is unlikely that ai will have much growth with the limited availability of relevant data. there is, of course, a chicken and egg problem. a major reason why services do not collect data is the limited usefulness of data in improving clinical care. while ai may offer the best possibility of increasing the usefulness of regularly collected data, such data will not be available until policy makers, funders, and providers deem it useful and are willing to devote financial resources to such data collection analysis. at present, there are no financial incentives for mental health providers to collect such data even if they improved services. moustafa et al. ( ) made the interesting observation that psychology is behind other fields in using big data. ai and big data are not considered core topics in psychology. the authors suggest several reasons for this, including that psychology is mostly theory-and hypothesis-driven rather than data-driven, and that studies use small sample sizes and a small number of variables that are typically categorical and thus are not as amenable to ai. moreover, most statistical packages used by psychologists are not well-equipped to analyze large data sets. however, the authors note that the method of clustering and thus differentiating among participants is used by psychologists and is in many ways similar to ai, especially deep neural networks, in trying to identify similar participants. using ml methods such as random forest algorithms, the investigator can identify variables that best explain differences among groups or clusters. instead of the typically few variables used by psychologists, ai can examine hundreds of variables. as a note of caution, rutledge et al. ( ) warn that "there is no silver bullet that can replace collecting enough data to generate stable and generalizable predictions" (p. ). while there are techniques that are often used in low sample size situations (e.g., the elastic net and tree-based ensembles), researchers need replications with independent samples if they are to have sufficient confidence in their findings. moreover, since big data are indeed big, they are easily misunderstood as automatically providing better results through smaller sampling errors. it is often not appreciated that the gain in precision drawn from larger samples may well be nullified by the introduction of additional population variance and biases. finding competent big data managers, data scientists, and programmers is a human resource problem. in my experience, ai scientists who are able and want to collaborate with mental health services researchers are rare. industry pays a lot more for these individuals than universities can afford. moreover, even within the health field, mental health is a very small component of the cost of services, so it is often ignored in this area. difficulty and resistance are encountered in the implementation of new technologies. clinicians are reluctant to adopt new approaches and to engage clients in new approaches and data collection procedures. community mental health services have been slow to successfully adopt new technologies (crutzen et al. ; lattie et al. ; yeager and benight ) . in their mixed methods study of community clinicians, crutzen et al. ( ) found there were concerns about privacy, the wide range of therapeutic techniques used, disruptions in trust and alliance, managing crises, and organizational issues such as billing and regulations contained in the privacy rule established by the health insurance portability and accountability act of (hipaa) that inhibited the use of new technologies. moreover, our current reimbursement policies do not support greater payment for better outcomes. thus, there is little or no financial incentive for hard-pressed community services to improve their services at their own expense. in fact, i would argue that there is a disincentive to improve outcomes since it results in increased costs (at least initially), organizational disruption and potentially a loss of clients if it takes less time and effort to successfully treat them. an interesting meta-issue has emerged from the widespread and ever-increasing investment in ai in healthcare. in a perceptive "viewpoint" published in jama, emanuel i would be happy to serve as a "matchmaker" for any ai programmers, data scientists (etc.), or behavioral scientists who are interested in collaborating on mental health projects. just contact me describing your background and interests and i will try to put together likeminded researchers. and wachter ( ), argue that the major challenge facing healthcare is not that of obtaining data and new analytics but the achievement of behavior change among both clinicians and patients. they point out the major failures of google and microsoft in not recognizing the problems in translating evidence into practice in connection with their large, web-based repositories for storage of health records, google health and microsoft healthvault, both of which have been discontinued. they indicate that the long delays in translation are due not primarily to data issues or lack of accurate predictions, but to the absence of behavioral changes needed for adoption of these practices. for example, the collection of longitudinal data has been problematic. another problem they note is that about half the people in the united states are nonadherent with medications. there is a huge gap between knowing what a problem is and actually solving it that "data gurus" seem to ignore. while this translation problem is evident in the sometimes narrow focus of ai promoters, it also represents an opportunity for the behavioral scientists engaged in ai research to marshal their skills and the knowledge gained from years of dealing with similar behavioral issues. the emergence of translational and implementation sciences, the latter more often led by behavioral scientists, can be of great service to the problems of applying ai to healthcare. the field of translational sciences has been developed and well-funded by the nih in recognition of the difficulty in using (i.e., translating) laboratory studies into practice. in , the budget for the clinical and translational science awards (ctsa) program was over a half billion dollars from to . however, as director of evaluation for vanderbilt's medical center's ctsa program for many years, i became very familiar with the difficulties in applying medical research in the real world. mental health is determined by multiple factors. it is unlikely that we will find a single vector such as a virus or a bacterium that causes mental illness. thus, data demands can include multiple systems with biological, psychological, sociological, economic, and environmental factors. within many of these domains, we do not have objective measures such as the lab tests found in medicine. subjective selfreports are prone to many biases, and many of the symptoms are not observable by observers. the lack of a strong theory of mental disorders also makes it difficult to intelligently focus on only a few variables. even with such apparently simple measures that include observations or recordings from multiple informants, we do not have a consensus on how to integrate them (bickman et al. a; martel et al. ). however, i would expect that research generated with ai will contribute not only to improved treatment but also to enhanced theories by including heterogeneous clients and many data sources. confidentiality and trust are key issues in mental health treatment. how will the introduction of ai affect the relationship between client and clinician? as noted earlier, there are problems, especially with deep learning, in interpreting the meaning of algorithmic solutions and predictions. our ability to explain the algorithms to clients is problematic. while many research projects outside of mental health show that combining ai with human judgment produces the best outcomes, this research is still in its infancy. a great deal has been written about ai in the context of medicine, but we need a reality check about the importance of ai in clinical practice. ben-israel et al. ( ) addressed the use of ai in a systematic review of the medical literature from to . the authors focused on human studies that addressed a problem in clinical medicine using one or more forms of ai. of the studies, only % were prospective. none of the studies included a power analysis, and half did not report attrition data. most were proof of concept studies. the authors concluded that their study showed that the use of ai in daily practice of clinical medicine is practically nonexistent. the authors acknowledge that use was defined by publication and that many applications of ai may be occurring without publication. regardless, this study suggests that there are many barriers that must be overcome before ai is more widely used. the self-help industry can provide perspective on digital apps, including some that use ai. it has been estimated that this sector was worth $ . billion in and is expected to be worth $ . billion in (la rosa ). part of that big dollar market is in digital mental health apps, although their precise monetary value is unknown. more to the point is that we know little about the effectiveness of digital apps in the marketplace (chandrashekar ) . moreover, many have warned that these unregulated and untested apps could be dangerous (wykes ) . in the united states, the publication of books is protected by the constitution, so there are no rules governing what can be published in the self-help sector. the market determines what gets accepted and used, regardless of effectiveness or negative side effects. but publication is limited by the cost of publishing and distribution. this is not the case for digital programs, where marginal costs of adding an additional user are negligible. unlike other mental health interventions, there are no licensing or ethical standards governing their use. there are no data being uniformly collected on their use and their effects. although there are u.s. government rules that can be applied to these apps (armontrout et al. ) , the law has many exceptions. the authors note that they could not find a single lawsuit related to software that diagnoses or treats a psychiatric condition. an interactive tool is provided by the federal trade commission to help judge which federal laws might apply in developing an app (https ://www.ftc.gov/tips-advic e/busin ess-cente r/guida nce/mobil e-healt h-apps-inter activ e-tool). it is clear that digital mental health apps will continue to grow. it is critical that services research and funding agencies do not overlook this development that might have potentially positive or negative effects. these are but a few of the many areas or ai needing additional research and potential limitations to be addressed. an excellent discussion of these and other relates issues regarding the potential hype common in the ai field is provided in the national academy of medicine's monograph on the use of ai in healthcare (matheny et al. ) . a thought-provoking paper by hagendorff and wezel ( ) classifies what ai can and cannot do. some of the authors' concerns, such as measurement, completeness and quality of the data, and problems with transparency of algorithms, have already been discussed, so i will describe those that i feel are most relevant to mental health services. the authors describe two methodological challenges, the first being that the data used in ai systems are not representative of reality because of the way they are collected and processed. this can lead to biases and problems with generalizability. second is the concern that supervised learning represents the past. thus, prediction can be based only on the past and not on expectations of change; thus, in some respects, change is inhibited. hagendorff and wezel ( ) also note several societal challenges. one such challenge they cite is that many software engineers who develop these algorithms do not have sufficient knowledge of the sociological, psychological, ethical, and political consequences of their software. they suggest this leads to misinterpretations and misunderstandings about how the software will operate in society. the authors also note the scarcity of competent programmers. i noted earlier that this is especially the case in academia and particularly in the behavioral sciences. the authors highlight that ai systems often produce hidden costs. this includes hardware to run the ai systems and, i would add, the disruptive nature of the intrusion of ai into a workflow. among the technological challenges discussed by hagendorff and wezel, i believe the authors' focus on the big differences between human thinking and intelligent machines is especially relevant to mental health. machines are in no way as complex as human brains; even ai's powerful neural networks, with more than a billion interconnections, represent only a tiny portion of the complexity of brain tissue. in order to obtain better convergence between machines and humans, hagendorff and wezel suggest that programmers follow the three suggestions made by lake et al. ( ) . first, programmers should move away from pattern recognition models, where most development started, to automated recognition of causal relationships. the second suggestion is to teach machines basic physical and psychological theories so that they have the appropriate background knowledge. the third suggestion is to teach machines to learn how to learn so that they can better deal with new situations. the comparison between ai and human thought is the only aspect of their paper where hagendorff and wezel mention causality issues. they note the challenge related to the inflexibility of many algorithms, especially the supervised ones, where simply changing one aspect would result in processing errors because that aspect was not in the training data. machines can be vastly superior to humans in some games where there are very specific inputs for achieving specific goals, but they cannot flexibly adapt to changes like humans. the authors suggest that promising technical solutions are being worked on to deal with this weakness in transferability. all these challenges will affect how well ai will work in mental health services. most problems will probably be solved, but the authors believe that some of these challenges will never be met, such as dealing with the differences between human and computer cognition, which means that ai will never fully grasp the context of mental health services. the machine's construction of a person may lead to a fragmented or distorted self-concept that conflicts with the person's own sense of identity, which seems critical to any analysis of the person's mental health or lack thereof. i do not have a sense of how serious this and the other challenges will be for us in the future, but it is clear that there is a lot more we need to learn. yet another set of concerns, specifically about the variation in ai called deep learning (dl), was enumerated by marcus ( ) , an expert in dl. in a controversial paper in which he identified limitations of dl, he noted that dl "may well be approaching a wall" (p. ) where progress will slow or cease. for example, he noted that dl is primarily a statistical approach for classifying data, using neural networks with multiple layers. dl "maps" the relationships between inputs and outputs. while children may need only a few trials to correctly identify a picture of a dog, dl may need thousands or even millions of labeled examples before making correct identifications without the labels. very large data sets are needed for dl. this is not the case for all ml techniques. i will not attempt to summarize the nine other limitations he sees with dl since many of them are noted elsewhere in this paper. he concludes that dl itself is not the problem; rather, the problem is that we do not fully understand the limitations of dl and what it does well. marcus warns against excessive hype and unrealistic expectations. i am taking this advice personally, and i am not expecting my tesla to be fully autonomous in as predicted by elon musk (woodyard ) . wolff ( ) provided an overview of how some of the problems of deep learning can be ameliorated. he responds to marcus using many of the subheadings in marcus's paper. he calls his framework the sp theory of intelligence, and its application is called the sp computer model (sp stands for simplicity and power). the theory was developed by wolff to integrate observations and concepts across several fields including ai, computing, mathematics, and human perception and cognition, using information compression to unify them. despite these and other concerns previously described, i do think that the advantages of ai for moving mental health services forward outweigh its disadvantages. however, this summary of advantages does not attempt to balance in length or number the disadvantages described above. i do not think it is necessary to repeat the already described numerous applications and potential applications of ai that can be used to improve health services. rather than repeating the numerous applications and potential applications of ai that can be used to improve health services, i highlight only a few key advantages. one of the main advantages is the way ai deals with data. it can handle large amounts of data from diverse sources. this includes structured (quantitative) and unstructured (text, pictures, sound) data in the same analyses. thus, it can integrate heterogeneous data from dissimilar sources. as noted earlier, the inclusion of non-traditional data such as those obtained from remote sensing (e.g., movement, facial expression, body temperature) will be responsible for a paradigm shift in what we consider relevant data. ai, if widely adopted, has the potential to have a major impact on employment. while most of the popular press coverage has been on the potential negative effects of eliminating many jobs, there also are potential positive effects. ai can reduce the costs of many tasks, thus increasing productivity. on the human side, it can streamline routine work and eliminate many boring aspects of work. it thus can free up workers to engage in the more complex and interesting aspects of many jobs. previous innovations have caused job dislocations. the classic loss of jobs in making buggy whips after the advent of automobiles is just one example. the inventions of the industrial age, such as steam engines, displaced many workers but also created many more new jobs. we know that many unskilled or semi-skilled jobs will be affected by ai in a major way. the elimination of cashiers with automated checkouts is now being implemented by amazon. in these stores, you scan your phone, and then ai and cameras take over. you just put products in your bag or cart and leave when you are finished. self-driving cars and trucks will greatly disrupt the transportation industry. we have weathered these disruptions in the past, but even the experts are unsure about how ai will influence jobs. probably the area in which there is the most positive potential in healthcare is when humans and machines collaborate in partnership. here, ai augments human tasks but keeps humans in the center. thus, physicians will no longer be separated by a laptop when speaking to a patient because ai will be able to record, take notes, and interpret the medical visit. we have documented the shortage of mental health workers and the immense gap between mental health needs and our ability to fill them. yes, we can train more clinicians, but our society seems unwilling to offer sufficient salaries to attract and keep such individuals. we have been experimenting with computers as therapists for more than years, but now we finally have the technological resources to develop and implement such approaches. we have started to use chatbots to extend services, but in the near future, ai may allow us to replace the human therapist under some conditions (hopp et al. ). in , the computer scientist and science fiction author vernor vinge developed the concept of a singularity in which artificial intelligence would lead to a world in which robots attain self-consciousness and are capable of what are now human cognitive activities (vinge ) . advocates and critics disagree on whether a singularity will be achieved and whether it would be a desirable development (braga and logan ) . braga and logan, editors of a special issue of information on the singularity and ai, conclude that although ai research is still in the early stage, the combination of human intelligence and ai will produce the best outcomes, but ai will never replace humans and we cannot fully depend on ai for the right answers. while these authors are well-informed, their crystal ball may not be clearer than anyone else's. the relevance of the singularity for healthcare lies in asking whether there will there be a time when ai-based computers are more effective and efficient than clinicians and will replace them. it is a question worth considering. i have presented a comprehensive, wide-ranging paper dealing with ai and mental health services. i have described major deficiencies of our current services, namely the lack of sufficient access, inadequate implementation, and low efficiency/effectiveness. i summarized how precision medicine and ai have contributed to improving healthcare in general and how these approaches are being applied in precision psychiatry and mental health. the paper then describes research that shows how ai has been or can be used to help solve the five problems i noted earlier. i then described the disadvantages and advantages of ai. in reviewing all this information, i believe there is one factor that i have not discussed sufficiently that clearly differentiates the way mental health services have been delivered and the way i expect they will be delivered in the future. i want to focus this last section of the paper on what i believe is the most important and significant change that can occur. this change is reflected in a simple question: is a human clinician necessary to deliver effective and efficient mental health services? i believe the answer to this question does not depend on the occurrence of the singularity but lies in the growth of ai research and its application to mental health services. i think there is widespread agreement that there are significant problems with diagnoses and the quality of our measures. moreover, most will probably agree that if ai can improve diagnoses and measures, then we should use utilize ai and let the results speak for themselves. the dependence on rcts will probably not be resolved by ai research, but ai can clearly help inform what should be tested in rcts. however, our current services overwhelmingly depend on human clinicians to deliver treatment. the problem with learning and feedback is that it requires clinicians to learn how to improve treatment over time with feedback. we are still uncertain about how well clinicians can learn from experience, training, and education (bacon ) . we also lack evidence of the best way to provide feedback to enhance that learning (bickman a; dyason et al. ). the problem of treatment precision is also currently tied to having the clinician deliver the treatment. while we can expect ai to deliver more precise information about treatment planning, we still depend on the clinician to interpret and deliver it with fidelity with some evidence-based model. a precision approach requires the clinician to systematically deliver treatment that is most appropriate to a specific client. we do not have good evidence that most clinicians can do that. i believe no other issue generates a bigger emotional response than the idea of the changing the role of the clinician. no other issue has the economic impact on services as the position of the clinician. i believe this issue is the most critical to the future of mental health services and will be most affected by ai. i note that in in writing an introduction to an extensive special issue of this journal called "therapist effects in mental health service outcome" (king ) , the authors of the introduction to that issue not did not note the potential role of ai in affecting clinicians (king and bickman ) . change is happening rapidly. mental health services are not alone in facing the issue of the role of humans, although human clinicians are probably more central to the provision of mental health services than other health services. a similar issue of the role of humans in the provision of services is being played out in surgery. surgery has been using robots for over years (bhandari et al. ), but the uptake has been slow for a variety of reasons. the next iteration of robot use is a move from using robots guided by surgeons to using robots assisted by ai and guided by surgeons. the use of ai may be seen as an intermediate step to fully autonomous ai-based robots not guided by surgeons. however, it is very clear that this progression is speculative and will take a long time to happen, if ever, given the consequences of errors. closer to our everyday experience is the similar path that the development of autonomous driving involves as we move toward the point at which a human driver is no longer needed. will mental health services follow a similar path? since we do not currently have a sufficient amount of research on using ai in treatment alone to inform us, we must look elsewhere for guidance. two bodies of literature are relevant. one deals with the use of computers and other technologies that do not include the use of ai at present, the second with self-help in which the participation of the clinician is minimal or totally absent. first, let us consider the existing literature that contrasts technology-based treatments with traditional face-to-face psychotherapy. then i will present some reviews of self-help research, followed by a description of the small amount of research using ai in treatment. a review of studies of internet-delivered cbt (icbt) to youth, using waitlist controls, supports the conclusion that cbt could be successfully adapted for internet-based treatment (vigerlan et al. ) . in a meta-analytic review of meta-analyses, containing studies of adult use of internet delivered via icbt, the authors concluded that icbt is as effective as face-to-face therapy (andersson et al. ) . hermes et al. ( ) include websites, software, mobile aps, and sensors as instances of what they call behavioral intervention technologies (bit). in their informative article, dealing primarily with implementation, they note that these technologies (they do not mention ai) can relate to a clinician in three ways: ( ) when intervention is delivered by the clinician and supported by bit, ( ) when bit provides the intervention with support from the clinician, or ( ) when intervention is fully automated with no role for the clinician. this schema clearly applies to the ai interventions and the role of clinicians as well. their conceptual model is helpful in understanding the parameters of implementation. they present a comprehensive plan for research to fill in the major gaps in the literature that addresses the question of comparative effectiveness of bit and traditional treatment. carlbring et al. ( ) conducted a systematic review and meta-analysis of eligible studies of ibct versus face-to-face cbt and reported that they produced equivalent outcomes, supporting the conclusions drawn by previous studies. it is also important to consider the issue of therapeutic alliance (ta) and its relationship to internet-based treatment. ta, to a large extent, is designed to capture the human aspect of the relationship between the clinician and the client. there are thousands of correlational studies that have established that ta is a predictor of treatment outcomes (flückiger et al. ) ; however, there are few studies of interventions that show a causal connection between ta and outcomes (e.g., hartley et al. ) . moreover, the very nature of ta as trait-like or state-like, which is central to causal assumptions, is being questioned and is subject to new research approaches (zilcha-mano ) as well as to questions about how it should be measured regardless of my doubts about the importance of ta, the fluckiger et al. ( ) meta-analysis found similar effect sizes (r = . ) for the alliance-outcome relationship in online interventions and in traditional face-to-face therapies. however, most of these studies were guided by a therapist, so the human factor was not totally absent. penedo et al. ( ) , in their study of a guided internet-based treatment, showed that it was important to align with the client's expectations and goals because these were related to outcomes, but no such relationship existed with the traditional third component of ta, bond with the supporting therapist, implying that ta might play a different role in internetbased treatments. i was trained as a social psychologist and was a graduate student of stanley milgram (of the famous obedience experiments), so i was curious about the research on the relationship between technological virtual agents and humans beyond the context of mental health treatment. several studies cited by schneeberger et al. ( ) showed that robots could get people to do tiring, shameful, or deviant tasks. the authors found that participants obeyed these virtual agents similarly to the way they responded to humans in a video-chat format. the participants did the same number of shameful tasks regardless of who or what was ordering them. moreover, doing the tasks produced the same level of shame and stress in the participant. they concluded that virtual agents and humans appear to have the same influence as human experimenters on participants. of course, there are many limitations associated with generalizing from this laboratory study, which was conducted with female college students in germany, but it does suggest that a great deal of research needs to be done on how humans relate to robots and virtual agents. miner et al. ( ) suggest that use of conversational ai in psychotherapy can be an asset for improving access to care, but there is limited research on efficacy and safety. can we learn about the role of the therapist from therapies that do not involve any therapist or technology? there is substantial research on self-help approaches from written material or what some call bibliotherapy. in general, research has supported the effectiveness of bibliotherapy before the advent of digital approaches. in , cuijpers et al. published a review of the literature that compared face-to face psychotherapy for depression and anxiety with guided selfhelp (i.e., with some therapist involvement) and concluded that they appeared comparable, but because there were so few studies in this comparison, this conclusion should be interpreted with caution. has the situation changed in the last decade? in a comprehensive review and meta-analysis almost years later, bennett et al. ( ) conducted a review and meta-analysis of studies. they concluded that self-help (both guided and unguided) had significant moderate to large effects on reducing symptoms of anxiety, depression, and disruptive behavior. however, there was also very high heterogeneity among the outcomes of these studies. compared to face-to-face therapy, self-help was better than no treatment but slightly worse than face-to-face treatments, guided therapy was better than unguided, and computerized treatment was better than bibliographic treatment. it is important to note that none of the studies were fully powered noninferiority trials, which would be a superior design. the authors concluded that their study showed potential near equivalence for self-help compared to faceto-face interventions, and their conclusions were consistent with several other reviews of self-help for mental health disorders in adults. the paper makes no mention of ai. cuijpers et al. ( ) conducted a network meta-analysis of trials of cbt addressing the question of whether format of delivery (individual, group, telephone-administered, guided self-help, or unguided self-help) influenced acceptability and effectiveness for these adult patients with acute depression. no statistically significant differences in effectiveness were found among these formats except that unguided self-help therapy was not more effective than care as usual but was more effective than a waitlist control group. the authors concluded that treatments using these different formats should be considered alternatives to therapist-delivered individual cbt. as in the previous publication, there was no mention of the use of ai, but cuijpers believes that few if any of the studies reviewed in his publication used ai (p. cuijpers, personal communication, march , ) . there is an emerging area of the use of ai in treatment that is informative. tuerk et al. ( ) , in a special section of current psychiatry reports focusing on psychiatry in a digital age, describe several approaches to using technology in evidence-based treatments. most relevant is their discussion of the use of ai in what has been called "conversational artificial intelligence" where there is a real-time interchange between a computer and a person. they note research that shows that this approach is low risk, high in consumer satisfaction, and high in self-disclosure. they suggest that there is a great deal of clinical potential in using ai in this manner. in a review of the literature from to on conversational agents used in the treatment of mental health problems, gaffney et al. ( ) found only qualifying studies out of an initial , with four being what they called full-scale rcts. they concluded that the use of conversational agents was limited but growing. all studies showed reduced psychological distress, with the five controlled studies showing a significant reduction compared to control groups. however, the three studies that used active controls did not show significant differences between the waitlist controls and use of a conversational agent, although all showed improvement. the authors concluded that the use of conversational agents in therapy looks promising, but not surprisingly, more research is needed. a similar conclusion on conversational agents was reached in another independent review (vaidyam et al. ) . i have little doubt that more research will be forthcoming in this emerging area. in summary, previous research using digital but not aipowered icbt, self-help (bibliotherapy), and ai-powered conversational agents suggests that effective treatment can be delivered without a human clinician under certain circumstances. i want to emphasize that these studies are suggestive but far from definitive. rather, they suggest that the role of the clinician is worth more exploration, but they do not establish the conclusion that we do not need clinicians to deliver services. we need to know a great deal more about how ai-supported therapy operates in different contexts. a survey of psychiatrists from countries asked about how technology will affect their future practice (doraiswamy et al. ) . only . % felt their jobs would become obsolete, and only a small minority ( %) felt that ai was likely to replace a human clinician in providing care. as much of the literature on the effects of ai on jobs suggests, those surveyed believed that ai would help in more routine tasks such as record keeping ( %) and synthesizing information, with about % believing their practices would be substantially changed. about % thought ai would have no influence or only minimal effect on their future work over the next years. another % thought their practices would be moderately changed by ai over the next years. more than three quarters ( %) thought it unlikely that technology would ever be able to provide care as well as or better than the average psychiatrist. only % of u.s.-based psychiatrists predicted that the potential benefits of future technologies or ai would outweigh the possible risks. some of the specific tasks that psychiatrists typically perform, including mental status examination, evaluation of dangerous behavior, and the development of a personalized treatment plan, were also felt to be tasks that a future technology would be unlikely to perform as well. i do not think many psychiatrists in this study are prepared for the major changes in their practices that are highly likely to occur in the next quarter century. in a thoughtful essay on the future of digital psychiatry, hariman et al. ( ) draw a number of conclusions. they predict major changes in practice, with treatment by an individual psychiatrist alone becoming rare. patients will receive treatment through their phones, participate in videoconferencing, and converse with chatbots. clinicians will receive daily updates on the patients through remote sensing devices and self-report. ai will be involved in both diagnosis and treatment and will integrate diverse sources of information. concerns over privacy and data security will increase. this is not the picture that the previously described survey of psychiatrists anticipated. brown et al. ( ) present the pros and cons of ai in an interesting debate format. on the pro side, the authors argue that while there are current limitations, the improvements in natural language processing (nlp) will lead to better clinical interviews. they point to research that shows people are more likely be honest with computers as a plus in obtaining more valid information from clients. they expect the ai "clinician" will be seen as competent and caring. they do note the danger that non-transparent ai will produce unintended negative side effects. those arguing against the use of ai clinicians acknowledge the technical superiority of ai to accomplish more routine tasks such as information gathering and tracking, but they point out the limitations even in the development of ai therapists. the lack of data needed to develop and test algorithms is critical. i have noted this in the discussion of the diagnostic muddle as a problem that ai can help solve, but these anti-ai authors argue that because psychiatrists disagree on diagnoses, there is no gold standard against which to measure the validity of ai models. this seems to be a rather unusual perspective from which to challenge change. they insightfully note that ai is different from human intelligence and does not perform well when presented with data that are different from training data. but the anti-ai authors acknowledge that more and better data may lead to improvement. brown et al. ( ) argue that common sense is something that ai cannot draw on; however, this seems to be a weak argument when common sense has been demonstrated to be inaccurate under many situations. they conclude with the statement that psychiatry "will always be about connecting with another human to help that individual" (p. ). this may be more wishful thinking than an accurate prediction about the future. those arguing the pro position state that the "the advance of ai psychiatry is inexorable" (p. ). on the other hand, the opponents of ai correctly point out that there is not yet sufficient evidence to draw a conclusion about the effectiveness of ai versus human clinicians. while there is disagreement about the potential advantages and disadvantages of ai, both sides agree that we need more and better research in this area. simon and yarborough ( ) present the case that ai should not be a major concern for mental health. they argue that ideally, our field would abandon the term artificial intelligence in regard to actual diagnosis and treatment of mental health conditions. using that term raises false hopes that machines will explain the mysteries of mental health and mental illness. it also raises false fears that all-knowing machines will displace human-centered mental health care. big data and advanced statistical methods have and will continue to yield useful tools for mental health care. but calling those tools artificially intelligent is neither necessary nor helpful. (p. ) the authors further take the position that despite the buildup around artificial intelligence, we need not fear the imminent arrival of "the singularity," that science fiction scenario of artificially intelligent computers linking together and ruling over all humanity. . . a scenario of autonomous machines selecting and delivering mental health treatments without human supervision or intervention remains in the realm of science fiction. (p. ) a more balanced approach to the role to the issue of replacement of clinicians by ai is presented by ahuja ( ) . after his review of the literature on medical specialists who may be replaced or more likely augmented by ai, his pithy take on this question is "or, it might come to pass that physicians who use ai might replace physicians who are unable to do so" (ahuja , p. ) . clearly, ai research will have to provide strong evidence of its effectiveness before ai will be accepted by some in the psychiatric community. there are several pressing questions about how mental health services should be delivered and about the future of mental health services. doubts about how much clinicians contribute to outcomes, our seeming inability to differentiate the effectiveness among clinicians except at the extremes, the lack of stability of employment of most community based clinicians, the poor track record on implementation of evidence-based programs, the cost of human services, the very limited availability of services especially where resources are inadequate-all lead to strong doubts about continuing the status quo of using clinicians as the primary way in which mental health services are delivered. in contrast, alternative approaches have many advantages. if scaled, ai therapists could be available to patients / and would not be bound to office hours. these ai therapists could represent any demographic or therapy style (e.g., directive) that the client preferred or that had been found to be more effective with a particular client. they can be specialists in any area for which there is sufficient research. in other words, not only can a personalized treatment plan be developed, but a personalized clinician (avatar) can be constructed for the best match with the client. of course, all these are putative advantages. as noted earlier, the application of ai is not without its risks and challenges, especially in putting together the interdisciplinary teams needed to accomplish this research. while i am optimistic about the potential contribution of ai to mental health services, it is just that-a potential. extensive research will be needed to learn whether these approaches produce positive outcomes when compared to traditional face-to face treatment, while also dealing with the ethical issues raised by ai applications. moreover, the quality of research needs significant improvement if we are going to have confidence in the findings. however, as exemplified by the rapid and uncontrolled growth of therapy apps, the world may not wait for rigorous supporting research before adopting a larger role for ai in mental health services. while my brief summaries of findings of ai in the medical literature are supportive of the application of ai, i do not want to give the impression that these positive findings are accepted uncritically. a deeper reading of many of these studies exposes methodological flaws that temper enthusiasm. for example, in reviewing comparisons between healthcare professionals and deep learning algorithms in classifying diseases of all types using medical imaging, x. liu et al. ( a) conclude that the ai models are equivalent to the accuracy of healthcare professionals. this review is the first to compare the diagnostic accuracy of deep learning models to health-care professionals; however, only a small number of the studies were direct comparisons. the authors also caution us by indicating what they labeled as the poor quality of many of the studies. the problems included low external validity (not done in a clinical practice setting), insufficient clarity in the reporting of results, lack of external validation, and lack of uniformity of metrics of diagnostic performance and deep learning terminology. however, the authors were encouraged by improvement in quality in the most recent studies analyzed. in commenting on the study, cook ( ) noted other limitations and concluded that it is premature to draw conclusions about the comparative accuracy of ai versus human physicians. if we are not more cautious, she warns that we will experience "inflated expectations on the gartner hype cycle" (p. e ). the latter refers to the examination of innovations and trends in ai. she cautions us to "stick to the facts, rather than risking a drop into the trough of disillusionment and a third major ai winter" (p. e ). many issues are raised in cook's paper, and the need to avoid the hype often found in the ai field is reiterated in the national academy of medicine's monograph on the use of ai in healthcare (matheny et al. ) . mental health services are changing. there are more than , mental health apps on the internet that are being used without much evidence of their effectiveness (marshall et al. ; bergin and davis ; gould et al. ) . the explosion of mental health apps is the leading edge of future autonomous interventions. however, there is pressure to bring some order to this chaos. probably the next innovation that will involve ai is its use in stepped therapy in which clients are typically triaged to low-intensity, low-cost care, monitored systematically, and stepped up to more intensive care if progress is not satisfactory . in this schema, the low-cost care could be ai-based apps with little risk to the client. if more confidence is gained in the safety and effectiveness of this type of protocol, the use of ai-based treatment would be expected to increase. the covid- pandemic will produce a major impact on mental health services. first, it is expected that the stresses caused by the pandemic will increase the demand for services (qiu et al. ; rajkumar ) . already poorly resourced mental health systems will not be able to meet this demand (Ćosić et al. ; ho et al. ; holmes et al. ) , especially in low resourced countries. however, the biggest change will be in the service delivery infrastructure. because of social distancing requirements, in-person delivery of therapy is being severely curtailed. while the major change at this time appears to be a shift to telemedicine (shore et al. ; van daele et al. ) , which is being adopted across almost all healthcare, there will need to be changes instituted in how clinicians are trained and supervised (zhou et al. ) . i have little doubt that ai will be adopted in order to increase efficiency and address the change in the service environment caused by the pandemic. in addition to changes initiated by the pandemic, there appear to be some changes in funding as a result of the protests concerning george floyd's killing. there is reconsideration of shifting some funding from police services to mental health and conflict reduction services to be delivered by personnel outside law enforcement (stockman and eligon ) . it will be difficult to meet this potential demand using the current infrastructure. the literature on ai and medicine is replete with warnings about the difficulties we face in integrating ai into our healthcare system. as a program evaluator, i appreciate the position paper describing the urgent need for well-designed and competently conducted evaluations of ai interventions as well as the guidelines provided by magrabi et al. ( ) . more suggestions for improving the quality of research on supervised machine learning can be found in the paper by cearns et al. ( ) . celi et al. ( ) describe the future in a very brief essay that is worth quoting: clinical practice should evolve as a hybrid enterprise with clinicians who know what to expect from, and how to work with, what is fundamentally a very sophisticated clinical support tool. working together, humans and machines can address many of the decisional fragilities intrinsic to current practice. the human-driven scientific method can be powerfully augmented by computational methods sifting through the necessarily large amounts of longitudinal patientand provider-generated data. (p. e ) however, research on ai, data science, and other technologies is in its infancy if not the embryonic stage of development. i am fully immersed in the struggle to implement several types of technologies in practice. changing the routine behavior of clinicians and clients is a major barrier to using new technologies, regardless of the effectiveness of these approaches. emanuel and wachter ( ) argue that the most important problem facing healthcare is not the absence of data or analytic approaches but turning predictions and findings into successful accomplishments through behavior change. alongside the investment in technology and analytics, we need to support the research and applications of psychologists, behavioral economists, and those working in the relatively new field of translational and implementation research. the emphasis on practical and implementable digital approaches requires a methodology that departs from the traditional efficacy approach, which does not focus on context and thus is difficult to translate to the real world. mohr et al. ( ) suggest a solution-based approach that focuses on three stages that they label create, trial and sustain. creation focuses on the initial stages of development, although not exclusively, and takes advantage of the unique characteristics of digital approaches that focus on engagement rather than trying to mimic traditional psychotherapy. trial must be dynamic because digital technologies rapidly change; rapid evaluations are required, such as continuous quality improvement strategies (bickman and noser ) . sustainability requires more from investigators and evaluators than publication of results; they must also produce sustainable implementation that no longer depends on a research project for support. we are currently in an ai summer in which there are important scientific breakthroughs and large investments in the application of ai (hagendorff and wezel ) . but ai has had several winters when enthusiasm for ai has waned and unreasonable expectations have cooled. we were confronted with the reality that ai could not accomplish everything that people thought it could and that investors and journalists had hyped. ai, at least in the near term, will not be the superintelligence that will destroy humanity or the ultimate solution that will solve all problems. enthusiasm for ai seems to run in cycles like the seasons. ai summers suffer from unrealistic expectations, but the winters bring an experience of disproportionate backlash and exaggerated disappointment. there was a severe winter in the late s, and another in the s and s (floridi ) . today, some are talking about another predictable winter (nield ; walch ; schuchmann ). floridi ( ) suggests that we can learn important principles from these cycles. first is whether ai is going to replace previous activities as the car did with the buggy, diversify activities as the car did with the bicycle, or complement and expand them as the plane did with the car. floridi asks how acceptable an ai that survives another winter will be. he suggests that we need to avoid oversimplification and think deeply about with we are doing with ai. in the june issue of the technology quarterly of the economist ( ), it is suggested that because ai's current summer is "warmer and brighter" than past ones because of widespread deployment of ai, "another fullblown winter is unlikely. but an autumnal breeze is picking up" (p. ). i have traced a path my career has taken from an almost exclusive focus on randomized experiments to consideration of the applications of ai. i have identified the main problems related to mental health services research's almost sole dependence on rct methodology. i have linked the problems with this methodology with the lack of satisfactory progress in developing sufficiently effective mental health services. the recent availability of ai and the value now being placed on precision medicine have produced the early stages of a revolution in healthcare that will determine how treatment will be developed and delivered. i anticipate that in the very near future, a first-year graduate student will be contemplating the same questions that i raised years ago, because they are still relevant, but this time he or she will realize that there are answers that were not available to me. acknowledgements this paper is part of a special issue of this journal titled "festschrift for leonard bickman: the future of children's mental health services." the issue includes a collection of original children's mental health services research articles, this article, three invited commentaries on this article, and a compilation of letters in which colleagues reflect on my career and on their experiences with me. the word festschrift is german and means a festival or celebration of the work of an author. there are many people to thank for their assistance in both the festschrift and this paper. first, i want to acknowledge my two colleagues and friends, nick ialongo and michael lindsey, who spontaneously originated the idea of a festschrift during a phone conversation with them. the folks at the johns hopkins bloomberg school of public health were great in supporting the daylong event held on may , . the many friends, family, former students and colleagues who traveled from around the country to attend and present made the event memorable. i am grateful to the committee that helped put this special issue together, which included marc atkins, catherine bradshaw, susan douglas, nick ialongo, kim hoagwood, and sonja schoenwald. this paper represents more than a yearlong effort for which many contributed including the scholars who provided email exchanges and ideas throughout the conceptualization and writing process. i thank the two editors of this special issue, sonja and catherine, who spent much of their valuable time on this project during a very difficult period. the manuscript was greatly improved through the efforts of my copy editor, diana axelsen. most of all i thank corinne bickman, who has been my partner in life for almost years and has managed this journal since its inception. without her support and love none of this would have been possible. funding no external funding was used in the preparation or writing of this article. conflict of interest from the editors: leonard bickman is editorin-chief of this journal and thus could have a conflict of interest in how this manuscript was managed. however, the guest editors of this special issue, entitled "festschrift for leonard bickman: the future of children's mental health services," managed the review process. three independent reviews of the manuscript were obtained and all recommended publication with some minor revisions, with which the editors concurred. while the reviewers were masked to the author, because of the nature of the manuscript is was not possible to mask the author for the reviewers. from the author: the author reported receipt of compensation related to the peabody treatment progress battery from vanderbilt university and a financial relationship with care software. no other disclosures were reported. this article does not contain any research conducted by the authors involving human participants or animals. this article did not involve any participants who required informed consent. sensing technologies for monitoring serious mental illnesses peeking inside the black-box: a survey on explainable artificial intelligence (xai) the impact of artificial intelligence in medicine on the future role of the physician the sage handbook of social research methods local causal and markov blanket induction for causal discovery and feature selection for classification part ii: analysis and extensions heterogeneity in psychiatric diagnostic classification. psychiatry research enhancing the patient involvement in outcomes: a study protocol of personalised outcome measurement in the treatment of substance misuse personalising the evaluation of substance misuse treatment: a new approach to outcome measurement a prospective study of therapist facilitative interpersonal skills as a predictor of treatment outcome internet interventions for adults with anxiety and mood disorders: a narrative umbrella review of recent meta-analyses. the canadian journal of psychiatry/la revue canadienne de psychiatrie current regulation of mobile mental health applications moving toward a precision-based, personalized framework for prevention science: introduction to the special issue being "smart" about adolescent conduct problems prevention: executing a smart pilot study in a juvenile diversion agency constructionist extension of the contextual model: ritual, charisma, and client fit responders to rtms for depression show increased front to-midline theta and theta connectivity compared to non-responders mental health services in schoolbased health centers: systematic review practitioner review: psychological treatments for children and adolescents with conduct disorder problems: a systematic review and meta-analysis feasibility of using real-world data to replicate clinical trial evidence the fort bragg evaluation: a snapshot in time ecological momentary assessment and intervention in the treatment of psychotic disorders: a systematic review practitioner review: unguided and guided self-help interventions for common mental health disorders in children and adolescents: a systematic review and meta-analysis the impact of machine learning on patient care: a systematic review. artificial intelligence in medicine technology matters: mental health apps-separating the wheat from the chaff youth depression alleviation with antiinflammatory agents (yoda-a): a randomised clinical trial of rosuvastatin and aspirin redesigning implementation measurement for monitoring and quality improvement in community delivery settings for whom does interpersonal psychotherapy work? a systematic review artificial intelligence and robotic surgery: current perspective and future directions social influence and diffusion of responsibility in an emergency the social power of a uniform social roles and uniforms: clothes make the person improving established statewide programs: a component theory of evaluation barriers to the use of program theory the fort bragg demonstration project: a managed continuum of care a continuum of care: more is not always better resolving issues raised by the ft. bragg findings: new directions for mental health services research practice makes perfect and other myths about mental health services my life as an applied social psychologist a measurement feedback system (mfs) is necessary to improve mental health outcomes administration and policy in mental health and mental health services research why can't mental health services be more like modern baseball? administration and policy in mental health and mental health services research youth mental health measurement (special issue) administration and policy in mental health and mental health services research implementing a measurement feedback system: a tale of two sites. administration and policy in mental health and mental health services research evaluating managed mental health care: the fort bragg experiment beyond the laboratory: field research in social psychology clinician reliability and accuracy in judging appropriate level of care the technology of measurement feedback systems effects of routine feedback to clinicians on mental health outcomes of youths: results of a randomized trial the fort bragg continuum of care for children and adolescents: mental health outcomes over five years achieving precision mental health through effective assessment, monitoring, and feedback processes. administration and policy in mental health and mental health services research meeting the challenges in the delivery of child and adolescent mental health services in the next millennium: the continuous quality improvement approach what counts as credible evidence in applied research and evaluation practice the sage handbook of applied social research methods the evaluation handbook: an evaluator's companion crime reporting as a function of bystander encouragement, surveillance, and credibility evaluation of a congressionally mandated wraparound demonstration comparative outcomes of emotionally disturbed children and adolescents in a system of services and usual care the relationship between change in therapeutic alliance ratings and improvement in youth symptom severity: whose ratings matter the most? administration and policy in mental health and mental health services research problems in using diagnosis in child and adolescent mental health services research analysis of cause-effect inference by comparing regression errors improving machine learning prediction performance for premature termination of psychotherapy handbook of social policy evaluation predicting social anxiety from global positioning system traces of college students: feasibility study ai and the singularity: a fallacy or a great opportunity? information the effects of routine outcome monitoring (rom) on therapy outcomes in the course of an implementation process: a randomized clinical trial will artificial intelligence eventually replace psychiatrists? methodology for evaluating mental health case management an introduction to machine learning methods for survey researchers single-subject prediction: a statistical paradigm for precision psychiatry machine learning for precision psychiatry: opportunities and challenges does big data require a methodological change in medical research? developing machine learning models for behavioral coding internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis recommendations and future directions for supervised machine learning in psychiatry an awakening in medicine: the partnership of humanity and intelligent machines. the lancet, digital health do mental health mobile apps work: evidence and recommendations for designing high-efficacy mental health mobile apps a logic model for precision medicine implementation informed by stakeholder views and implementation science inflammatory biomarkers for mood disorders: a brief narrative review a tale of two deficits: causality and care in medical ai systematic effect of random error in the yoked control design meta-analysis of the rdoc social processing domain across units of analysis in children and adolescents advancing ambulatory biobehavioral technologies beyond "proof of concept": introduction to the special section current state and future directions of technology-based, ecological momentary assessment and intervention for major depressive disorder: a systematic review the effectiveness of clinician feedback in the treatment of depression in the community mental health system advancing the science and practice of precision education to enhance student outcomes human versus machine in medicine: can scientific literature answer the question? the lancet: digital health impact of human disasters and covid- pandemic on mental health: potential of digital psychiatry services for adolescents with psychiatric disorders: -month data from the national comorbidity survey-adolescent machine learning for clinical psychology and clinical neuroscience the cambridge handbook of research methods in clinical psychology. cambridge handbooks in psychology psychological therapies versus antidepressant medication, alone and in combination for depression in children and adolescents can interest and enjoyment help to increase use of internet-delivered interventions? is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? a systematic review and meta-analysis of comparative outcome studies effectiveness and acceptability of cognitive behavior therapy delivery formats in adults with depression: a network meta-analysis testing moderation in network meta-analysis with individual participant data inflammatory cytokines in children and adolescents with depressive disorders: a systematic review and meta-analysis on multi-cause causal inference with unobserved confounding: counterexamples, impossibility, and alternatives integrating artificial and human intelligence in complex, sensitive problem domains: experiences from mental health introduction to the special issue: discrepancies in adolescent-parent perceptions of the family and adolescent adjustment reflections on randomized control trials comparison of machine learning methods with traditional models for use of administrative claims with electronic medical records to predict heart failure outcomes real-world evidence: promise and peril for medical product evaluation artificial intelligence and the future of psychiatry: insights from a global physician survey extracting psychiatric stressors for suicide from social media using deep learning deep neural networks in psychiatry out with the old and in with the new? an empirical comparison of supervised learning algorithms to predict recidivism machine learning approaches for clinical psychology and psychiatry does feedback improve psychotherapy outcomes compared to treatment-as-usual for adults and youth? psychotherapy research effects of providing domain specific progress monitoring and feedback to therapists and patients on outcome what is the test-retest reliability of common task-functional mri measures? new empirical evidence and a meta-analysis psychometrics of the personal questionnaire: a client-generated outcome measure artificial intelligence in health care: will the value match the hype? barriers and facilitators of mental health programmes in primary care in low-income and middle-income countries dermatologist-level classification of skin cancer with deep neural networks consumer participation in personalized psychiatry the new field of "precision psychiatry open trial of a personalized modular treatment for mood and anxiety ai and its new winter: from myths to realities the alliance in adult psychotherapy: a meta-analytic synthesis commentary: a refresh for evidencebased psychological therapies-reflections on marchette and weisz refining the costs analyses of the fort bragg evaluation: the impact of cost offset and cost shifting the effectiveness of psychosocial interventions delivered by teachers in schools: a systematic review and metaanalysis risk factors for suicidal thoughts and behaviors: a meta-analysis of years of research chronic inflammation in the etiology of disease across the life span conversational agents in the treatment of mental health problems: mixed-method systematic review utilization of machine learning for prediction of posttraumatic stress: a re-examination of cortisol in the prediction and pathways to non-remitting ptsd toward achieving precision health methodological advances in statistical prediction automated identification of diabetic retinopathy using deep learning change what? identifying quality improvement targets by investigating usual mental health care. administration and policy in mental health and mental health services research an artificial neural network for movement pattern analysis to estimate blood alcohol content level the association of therapeutic alliance with long-term outcome in a guided internet intervention for depression: secondary analysis from a randomized control trial feedback from outcome measures and treatment effectiveness, treatment efficiency, and collaborative practice: a systematic review. administration and policy in mental health and psychotherapy expertise should mean superior outcomes and demonstrable improvement over time veterans affairs and the department of defense mental health apps: a systematic literature review how are information and communication technologies supporting routine outcome monitoring and measurement-based care in psychotherapy? a systematic review detecting depression and mental illness on social media: an integrative review the gap between science and practice: how therapists make their clinical decisions challenges for ai: or what ai (currently) can't do r. a. fisher and his advocacy of randomization smartphone sensing methods for studying behavior in everyday life. current opinion in behavioral sciences the future of digital psychiatry effective nurse-patient relationships in mental health care: a systematic review of interventions to improve the therapeutic alliance prediction of rtms treatment response in major depressive disorder using machine learning techniques and nonlinear features of eeg signal big data and causality the value of psychiatric diagnoses applied research design: a practical guide family empowerment: a theoretically driven intervention and evaluation measuring the implementation of behavioral intervention technologies: recharacterization of established outcomes therapist expertise in psychotherapy revisited deep learning: a technology with the potential to transform health care mental health strategies to combat the psychological impact of covid- beyond paranoia and panic interpreting nullity: the fort bragg experiment: a comparative success or failure? improving mental health access for low-income children and families in the primary care setting overview of the national evaluation of the comprehensive community mental health services for children and their families program multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science methods of delivering progress feedback to optimise patient outcomes: the value of expected treatment trajectories big data and the precision medicine revolution psychosocial interventions for people with both severe mental illness and substance misuse technology-enhanced human interaction in psychotherapy iom roundtable on evidence-based medicine: the learning healthcare system: workshop summary challenges of using progress monitoring measures: insights from practicing clinicians machine learning and psychological research: the unexplored effect of measurement an upper limit to youth psychotherapy benefit? a meta-analytic copula approach to psychotherapy outcomes obama gives east room rollout to precision medicine initiative predictors of response to repetitive transcranial magnetic stimulation in depression: a review of recent updates identification of patients in need of advanced care for depression using data extracted from a statewide health information exchange: a machine learning approach diagnosis of human psychological disorders using supervised learning and nature-inspired computing techniques: a meta-analysis annual research review: expanding mental health services through novel models of intervention delivery exploring the black box: measuring youth treatment process and progress in usual care. administration and policy in mental health and the session report form (srf): are clinicians addressing issues of concern to youth and caregivers? administration and policy in mental health and mental health services research personalized evidence based medicine: predictive approaches to heterogeneous treatment effects machine learning methods for developing precision treatment rules with observational data a preliminary precision treatment rule for remission of suicide ideation. suicide and life-threatening behavior predicting suicides after psychiatric hospitalization in u.s. army soldiers: the army study to assess risk and resilience in servicemembers (army starrs) therapist effects in mental health service outcome. administration and policy in mental health and mental health services research is there a future for therapists? administration and policy in mental health and mental health services research the metamorphosis immunopharmacogenomics towards personalized cancer immunotherapy targeting neoantigens examination of real-time fluctuations in suicidal ideation and its risk factors: results from two ecological momentary assessment studies the effects of feedback interventions on performance: a historical review, a meta-analysis, and a preliminary feedback intervention theory academy of science of south africa (assaf)). available at preventing cytokine storm syndrome in covid- using α- adrenergic receptor antagonists prediction models of functional outcomes for individuals in the clinical high-risk state for psychosis or with recent-onset depression: a multimodal, multisite machine learning analysis predicting response to repetitive transcranial magnetic stimulation in patients with schizophrenia using structural magnetic resonance imaging: a multisite machine learning analysis how artificial intelligence could redefine clinical trials in cardiovascular medicine: lessons learned from oncology building machines that learn and think like people collecting and delivering progress feedback: a meta-analysis of routine outcome monitoring an overview of scientific reproducibility: consideration of relevant issues for behavior science/analysis the $ billion self-improvement market adjusts to a new generation opportunities for and tensions surrounding the use of technology-enabled mental health services in community mental health care. administration and policy in mental health and mental health services research predicting major mental illness: ethical and practical considerations modified causal forests for estimating heterogeneous causal effects applications of machine learning algorithms to predict therapeutic outcomes in depression: a meta-analysis and systematic review development and validation of multivariable prediction models of remission, recovery, and quality of life outcomes in people with first episode psychosis: a machine learning approach a framework for advancing precision medicine in clinical trials for mental disorders implementing measurement-based care in behavioral health: a review ethics in the era of big data a comparison of deep learning performance against health-care professionals in detecting diseases from medical imaging: a systematic review and meta-analysis difficulties and challenges in the development of precision medicine how to read articles that use machine learning: users' guides to the medical literature detecting cancer metastases on gigapixel pathology images the future of precision medicine: potential impacts for health technology assessment automated assessment of psychiatric disorders using speech: a systematic review towards integrating personalized feedback research into clinical practice: development of the trier treatment navigator (ttn) implementing routine outcome measurement in psychosocial interventions: a systematic review artificial intelligence in clinical decision support: challenges for evaluating ai and practical implications causal discovery algorithms: a practical guide applications of machine learning in addiction studies: a systematic review. psychiatry research practitioner review: empirical evolution of youth psychotherapy toward transdiagnostic approaches deep learning: a critical appraisal clinical or gimmickal: the use and effectiveness of mobile mental health apps for treating anxiety and depression research review: multi-informant integration in child and adolescent psychopathology diagnosis artificial intelligence in health care: the hope, the hype, the promise, the peril in the face of stress: interpreting individual differences in stress-induced facial expressions rapid detection of internalizing diagnosis in young children enabled by wearable sensors and machine learning the state of mental health in america improving moderator responsiveness in online peer support through automated triage recent advances in deep learning: an overview key considerations for incorporating conversational ai in psychotherapy the ethics of biomedical 'big data' analytics a randomized noninferiority trial evaluating remotely-delivered stepped care for depression using internet cognitive behavioral therapy (cbt) and telephone cbt personal sensing: understanding mental health using ubiquitous sensors and machine learning . the complex etiology of ptsd in children with maltreatment applying big data methods to understanding human behavior and health comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis rethinking the experiment: necessary (r)evolution the angel and the assassin: the tiny brain cell that changed the course of medicine. ballantine. national institutes of health, central resource for grants and funding information is deep learning already hitting its limitations? and is another ai winter coming? towards data science neurobiological mechanisms of repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex in depression: a systematic review progress in childhood cancer: years of research collaboration, a report from the children's oncology group dissecting racial bias in an algorithm used to manage the health of populations estimating the reproducibility of psychological science research handbook on the law of artificial intelligence using learning analytics to scale the provision of personalised feedback integrity of evidence-based practice: are providers modifying practice content or practice sequencing? administration and policy in mental health and mental health services research computational approaches and machine learning for individual-level treatment predictions a critical review of consumer wearables, mobile applications, and equipment for providing biofeedback, monitoring stress, and sleep in physically active populations causality: models, reasoning, and inference causal inference in statistics: an overview the seven tools of causal inference, with reflections on machine learning a machine learning ensemble to predict treatment outcomes following an internet intervention for depression can machine learning improve screening for targeted delinquency prevention programs? prevention science mechanism of repetitive transcranial magnetic stimulation for depression. shanghai archives of psychiatry what makes a good counselor? learning to distinguish between high-quality and low-quality counseling conversations experiencing mental health diagnosis: a systematic review of service user, clinician, and carer perspectives across clinical settings abandoning personalization to get to precision in the pharmacotherapy of depression endocrine and immune effects of non-convulsive neurostimulation in depression: a systematic review. brain, behavior, and immunity can machine learning help us in dealing with treatment resistant depression? a review potential liability for physicians using artificial intelligence a nationwide survey of psychological distress among chinese people in the covid- epidemic: implications and policy recommendations emotion recognition using smart watch sensor data: mixed-design study covid- and mental health: a review of the existing literature chexnet: radiologist-level pneumonia detection on chest x-rays with deep learning a million variables and more: the fast greedy equivalence search algorithm for learning high-dimensional graphical causal models, with an application to functional magnetic resonance images transparency in algorithmic decision making a machine learning approach to predicting psychosis using semantic density and latent content analysis. npj schizophrenia the peabody treatment progress battery: history and methods for developing a comprehensive measurement battery for youth mental health using program theory to link social psychology and program evaluation stand-alone artificial intelligence for breast cancer detection in mammography: comparison with radiologists big data analytics and ai in mental healthcare the secrets of machine learning: ten things you wish you had known earlier to be more effective at data analysis speculations on the future of psychiatric diagnosis machine learning and big data in psychiatry: toward clinical applications using artificial intelligence to assess clinicians' communication skills causal protein-signaling networks derived from multiparameter single-cell data psychotherapists openness to routine naturalistic idiographic research individualized patient-progress systems: why we need to move towards a personalized evaluation of psychological treatments patient-centered assessment in psychotherapy: a review of individualized tools the individualised patient-progress system: a decade of international collaborative networking explainable artificial intelligence: understanding, visualizing and interpreting deep learning models the effectiveness of school-based mental health services for elementary-aged children: a metaanalysis editorial: in the causal labyrinth: finding the path from early trauma to neurodevelopment personalized and precision medicine informatics. a workflow-based view computational causal discovery for posttraumatic stress in police officers machine learning methods to predict child posttraumatic stress: a proof of concept study a complex systems approach to causal discovery in psychiatry personal values and esp scores would you follow my instructions if i was not human? examining obedience towards virtual agents time for one-person trials probability of an approaching ai winter. towards data science ecological momentary interventions for depression and anxiety the present and future of precision medicine in psychiatry: focus on clinical psychopharmacology of antidepressants machine learning in mental health: a scoping review of methods and applications psychosocial interventions and immune system function: a systematic review and meta-analysis of randomized clinical trials non-gaussian methods for causal structure learning telepsychiatry and the coronavirus disease pandemic-current and future outcomes of the rapid virtualization of psychiatric care a svm-based classification approach for obsessive compulsive disorder by oxidative stress biomarkers good news: artificial intelligence in psychiatry is actually neither psychoneuroimmunology of stress and mental health social safety theory: a biologically based evolutionary perspective on life stress, health, and behavior from stress to inflammation and major depressive disorder: a social signal transduction theory of depression efficacy of repetitive transcranial magnetic stimulation in treatment-resistant depression: the evidence thus far. general psychiatry chronic systemic inflammation is associated with symptoms of latelife depression: the aric study outcomes from wraparound and multisystemic therapy in a center for mental health services system-of-care demonstration site gems [gene expression model selector]: a system for automated cancer diagnosis and biomarker discovery from microarray gene expression data final report on the aspirin component of the ongoing physicians' health study everybody lies: big data, new data and what the internet can tell us about who we really are cities ask if it's time to defund police and 'reimagine' public safety a system of care for children and youth with severe emotional disturbances study finds psychiatric diagnosis to be 'scientifically meaningless the "average" treatment effect: a construct ripe for retirement. a commentary on deaton and cartwright using effect size-or why the p value is not enough everything you wanted to know about smart health care: evaluating the different technologies and components of the internet of things for better health commercial influences on electronic health records and adverse effects on clinical decision making primed for psychiatry: the role of artificial intelligence and machine learning in the optimization of depression treatment a comparison of natural language processing methods for automated coding of motivational interviewing development and evaluation of clientbot: patientlike conversational agent to train basic counseling skills will machine learning enable us to finally cut the gordian knot of schizophrenia? schizophrenia empirically based mean effect size distributions for universal prevention programs targeting school-aged youth: a review of meta-analyses outcome and progress monitoring in psychotherapy: report of a canadian psychological association task force think s-ai-is-moreprofo und-than-fire#:~:text=%e % % cai% i s% o ne% o f% t he repetitive transcranial magnetic stimulation elicits antidepressant-and anxiolytic-like effect via nuclear factor-e -related factor -mediated anti-inflammation mechanism in rats deep medicine: how artificial intelligence can make healthcare human again high-performance medicine: the convergence of human and artificial intelligence applications of machine learning in real-life digital health interventions: review of the literature adapting evidence-based treatments for digital technologies: a critical review of functions, tools, and the use of branded solutions an understanding of ai's limitations is starting to sink in chatbots and conversational agents in mental health: a review of the psychiatric landscape the neuroactive potential of the human gut microbiota in quality of life and depression recommendations for policy and practice of telepsychotherapy and e-mental health in europe and beyond fairer machine learning in the real world: mitigating discrimination without collecting sensitive data internet-delivered cognitive behavior therapy for children and adolescents: a systematic review and meta-analysis how to survive in the post-human era. in interdisciplinary science and engineering in the era of cyberspace a systematic literature review of the clinical efficacy of repetitive transcranial magnetic stimulation (rtms) in non-treatment resistant patients with major depressive disorder are we heading for another ai winter soon? forbes the great psychotherapy debate: the evidence for what makes psychotherapy work what do clinicians treat: diagnoses or symptoms? the incremental validity of a symptom-based, dimensional characterization of emotional disorders in predicting medication prescription patterns evidence-based youth psychotherapies versus usual clinical care: a meta-analysis of direct comparisons more of what? issues raised by the fort bragg study performance of evidence-based youth psychotherapies compared with usual clinical care: a multilevel meta-analysis what five decades of research tells us about the effects of youth psychological therapy: a multilevel meta-analysis and implications for science and practice are psychotherapies for young people growing stronger? tracking trends over time for youth anxiety, depression, attention-deficit/hyperactivity disorder, and conduct problems compliance with mobile ecological momentary assessment protocols in children and adolescents: a systematic review and meta-analysis can machine-learning improve cardiovascular risk prediction using routine clinical data? advances in statistical methods for causal inference in prevention science: introduction to the special section elon musk vows fully self-driving teslas this year and 'robotaxis' ready next year. usa today solutions to problems with deep learning computer-assisted cognitive-behavior therapy and mobile apps for depression and anxiety comparing sequencing assays and human-machine analyses in actionable genomics for glioblastoma development and validation of a machine learning individualized treatment rule in first-episode schizophrenia racing towards a digital paradise or a digital hell if we build it, will they come? issues of engagement with digital health interventions for trauma recovery. mhealth, , the role of telehealth in reducing the mental health burden from covid- . telemedicine and e-health is the alliance really therapeutic? revisiting this question in light of recent methodological advances major developments in methods addressing for whom psychotherapy may work and why key: cord- - a szj x authors: ibrahim, mohamed izham mohamed title: chapter assessment of medication dispensing and extended community pharmacy services date: - - journal: social and administrative aspects of pharmacy in low- and middle-income countries doi: . /b - - - - . - sha: doc_id: cord_uid: a szj x abstract individuals who visit community pharmacies are regarded as customers rather than patients. the public tends to view community pharmacists as businesspeople. several factors influence individuals' willingness to patronize and to continue visiting such pharmacies. on the supply side, community pharmacists' responsibilities and duties center on the health and well-being of society. in this chapter, an assessment of community pharmacy practices in developing countries is particularly interesting in terms of medication dispensing and extended pharmacy services that promote public wellness. community pharmacists in developing countries, who are supposedly strategically positioned in the community to provide public health, are not taking advantage on this opportunity. although several studies have noted the services provided by community pharmacists, in general, the practice is far from meeting expectations due to several barriers. pharmacists need to realize their opportunities and potential for success as both professionals and businesspeople. pharmacists serve individual, community, and societal needs. brodie ( ) proposed that pharmacists' basic role has to expand based on advancements in technology and knowledge. in the past, pharmacists' main purpose was to prepare medicines and to ensure their availability. however, pharmacists can now react to external forces (e.g., economic, epidemiological, demographic, and technological) that are reshaping the profession by positioning themselves within the medication use system and being in control of the process. helper ( ) suggested that pharmacists be more knowledgeable and focus on their fundamental pharmacist-society relationship to improve public health. in , who defined health in its constitution: health is a state of complete physical, mental and social well-being, not merely the absence of disease or infirmity. this is the most quoted definition of health, which clearly stresses "well-being." four decades later, who ( ) revised its definition as follows: health is the extent to which an individual or group is able, on the one hand, to realize aspirations and satisfy needs; and, on the other hand, to change or cope with the environment. health is, therefore, seen as a resource for everyday life, not an object of living; it is a positive concept emphasizing social and personal resources, as well as physical capacities. in developing countries, healthcare needs are more pressing than those in developed nations. unfortunately, for various reasons, the provision of care is inadequate, particularly in the public sector; it is even worse in the private sector. who ( ) has highlighted the importance of improving, monitoring, and evaluating people's wellness and quality of life, which, as a public health concern, should be the goals in a country's national development. in , winslow defined public health as follows: [public health is] the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals. (winslow, ) public health is an organized effort to maintain the health of the people and to prevent illness, injury, and premature death by focusing on prevention and health protection services (the association of faculties of medicines of canada, n.d.) . another relevant community-related concept is primary healthcare. primary healthcare was the core concept of who's goal in health for all, which was based on the alma ata declaration in (who, ) . due to high healthcare expenditures, moving some of the healthcare focus from the tertiary level to the primary level is perhaps justifiable. primary care also aims to decrease the public's reliance on hospitals to fill drug prescriptions. according to who, to achieve health for all, people must be put at the center of healthcare (who, ) . people-centered care is focused and organized around the health needs and expectations of people and communities rather than on disease itself (who, ) . if people and society are the core of the "health for all" mission, then where do community pharmacists belong as healthcare providers? do the pharmacy and community pharmacists fit within the system? in this chapter, an assessment of community pharmacy practices in developing countries is particularly interesting in terms of medication dispensing and extended pharmacy services. the chapter also seeks to examine the significant societal contributions of community pharmacists, including the challenges and gaps in practice. this chapter will also focus and discuss the expected role, function, and responsibilities of community pharmacists in developing countries. this is based on the aforementioned concepts of "health," "public health," and "primary healthcare." a community pharmacy is a healthcare facility that provides pharmaceutical and cognitive services to a specific community. from independently owned pharmacies to corporately owned chain pharmacies, a variety of pharmacies are in operation. in some developing countries in africa and asia, the terms "drug outlets," "retail drug outlets," "retail drug shops," and "private pharmacies" are commonly used. community pharmacists must strategically position themselves in the community to serve the public health. community pharmacies can be found on main streets, in malls and supermarkets, at the heart of the most rural villages, and in the center of the most deprived communities. in some countries, many community pharmacies are opened early and closed late when other healthcare professionals are unavailable (cpni, no date). according to who ( ) , among healthcare providers, community pharmacists are the most accessible to the public. in practice, a pharmacy provides medications and other healthcare products and services and helps people and society make the best use of them (wiedenmayer et al., ) . community pharmacists supply, dispense, and sell medications according to the law. a proper dispensing practice will interpret and evaluate a prescription; select and manipulate or compound a pharmaceutical product; and label and supply the product in an appropriate container according to legal and regulatory requirements (who, ) . in addition, pharmacy activities include a pharmacist's provision of information and instructions to patients, and, under a pharmacist's supervision, practices will ensure the patient's safe and effective use of the medicines. in some countries, pharmaceutical services go beyond these basic services. these services or functions (e.g., counseling, drug information, blood pressure monitoring, immunizations, and diabetic selfmanagement) will require professional knowledge and skills beyond those required to dispense prescription medications (wiedenmayer et al., ) . these services include all those delivered by pharmacy personnel to support the delivery of pharmaceutical care. beyond the supply of pharmaceutical products, pharmaceutical services include information, education, and communication to promote public health; the provision of drug information and counseling; regulatory services; and staff education and training (wiedenmayer et al., ) . hepler and strand ( ) coined the term "pharmaceutical care," which they defined as "the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve (or maintain) a patient's quality of life." this collaborative process aims to prevent or identify and solve pharmaceutical and health-related problems-a continuous quality improvement process regarding the use of medicines (wiedenmayer et al., ) . the philosophy of pharmaceutical care promoted in the early s is no longer new. many studies, initiatives, and interventions, especially in developed countries, have been conducted to improve patient care and health outcomes. in an attempt to provide health and pharmaceutical care to patients and society, the healthcare and pharmaceutical sectors in developing countries, particularly low-and middle-income countries (lmics), are facing challenges. these challenges include the shortage of human resources in the pharmacy workforce; inefficient health systems; the rising costs of medicines and healthcare; limited financial resources; the huge burden of disease; and changing social, epidemiological, technological, economic, and political situations (mohamed ibrahim, palaian, al-sulaiti, & el-shami, ) . in general, pharmacists play an important role in the healthcare system through the provision of medicines and information (accp, no date). pharmacists are drug experts who focus on patients' health and wellness. the competency standards for pharmacists in australia (shpa, ) mentioned several important functional areas that community pharmacists could assume: dispensing medication; preparing pharmaceutical products; promoting and contributing to the quality use of medication; providing primary healthcare; and supplying information and instructions related to health and medication. what kind of value and benefits does the public really gain from community pharmacy practice? despite the widely acknowledged potential of community pharmacies in developing countries to respond to public healthcare needs, related developments have been limited (smith, ) . in addition, the quality of community pharmacy practices has also been questioned. in many countries, especially in lmics, community pharmacists have only performed the basic or traditional role (i.e., as a drug dispenser), and they have sometimes indulged in unethical practices. studies have reported mixed findings: community pharmacies make a contribution to society, but they are also problematic (i.e., they do not meet expectations and provide low-quality services). in estonia, since the restoration of independence in , community pharmacies have become more patient-oriented, even though the government has not pressured pharmacies to offer extended services. in addition to dispensing, pharmacies still compound extemporaneous products and sell herbal medicines. community pharmacists continue to perform their traditional roles (volmer, vendla, vetka, bell, & hamilton, ) . prior to , clinical pharmacy was never practiced in community pharmacy settings in peru. however, the pharmaceutical care initiative has been reported to be growing and well supported by the law. peruvian pharmacists are encouraged to take this opportunity to expand their services (alvarez-risco & van mil, ) . in china, pharmaceutical care services are underdeveloped but, with the improvement of the chinese pharmacist law, they will become an important part of the pharmacist's professional role (fang, yang, zhou, jiang, & liu, ) . pharmacists in vietnam are encouraged to expand their role-from drug sellers to client counselors, drug treatment managers, adherence counselors, and advisors on illness prevention. pharmacies are often the first place that people visit to seek medical help, and they serve as a source of health information and services. the intervention that has empowered pharmacists to serve as client advocates and client counselors has identified a few improvements, such as knowledge, behavior, increased client satisfaction, and pharmacist-healthcare provider relationships. pharmacists can move beyond the traditional role of selling drugs to be more effective healthcare professionals, and they need continuing professional development (cpd) (minh, huong, byrkit, & murray, ) . from another perspective, evidence has shown that community pharmacists perform far below public expectations. patients have encountered several problems and challenges related to community pharmacy practice, which can be discussed according to pharmacy, pharmacist, prescription, service, and system factors. studies have reported that community pharmacists in developing countries, especially lmics, do not provide quality services. a quick look at developing countries shows that the community pharmacy practice setting is regarded as popular. unfortunately, this practice setting also presents some concerns. for example, some countries allow nonpharmacists to operate pharmacies and to handle medicines. in some countries, the practice of community pharmacy is not well regulated, with little to no minimum standard of practice (hussain, mohamed ibrahim, & zaheer, d) . many pharmacy personnel who dispense medicines are unqualified, with no college/university diploma or professional degree in pharmacy (lenjisa, mosisa, woldu, & negassa, ) . a study in turkish republic of northern cyprus (gokcekus, toklu, demirdamar, & gumusel, ) reported that the pharmacy employees have no pharmacybased training and that pharmacists believed that their employees are capable to handle the prescriptions. studies in qatar, pakistan, malaysian, and sudan have indicated that dispensing and labeling practices and provider-patient interactions are poor (alamin hassan, mohamed ibrahim, & hassali, ; hussain & mohamed ibrahim, ; hussain et al., d; mohamed ibrahim et al., ; osman, ahmed hassan, & mohamed ibrahim, ) . in addition, a few dispensing errors have been identified (lenjisa et al., ) . according to basak, arunkumar, and masilamani ( ) , community pharmacy services in india are quite problematic, and the pharmacy's role in healthcare remains unrecognized. these authors have called for reform to meet societal needs. a study in nigeria found that some community pharmacists often administer injections for customers-in some cases, without a prescription. the number of prescriptions that community pharmacists receive is low. they suffer from the limited availability of some resources, which has a serious impact on their practice (adje & oli, ) . a review of community pharmacy practices showed that, in some countries, pharmacy outlets were run by nonpharmacists; dispensing practices were unsatisfactory; drug sellers' level of knowledge regarding diseases and medicines was poor; medicines were used irrationally; pharmacies were not meeting the government's licensing requirements; medication storage conditions were improper; and customers could hardly meet with pharmacists (hussain, mohamed ibrahim, & babar, a , b , d hussain & mohamed ibrahim, ) . a study on over-the-counter (otc) counseling in brazil (halila, junior, otuki, & correr, ) concluded that even though the most important factors taken into account when counseling an otc medicine were drug's efficacy and adverse effects, but only few pharmacists knew the meaning of terms related to evidence-based health. poudel, subish, mishra, mohamed ibrahim, and jayasekera ( ) reported that unregistered fixed-dose combinations of pharmaceutical products (e.g., antimicrobial combinations, nonsteroidal antiinflammatory drug combinations, and antimotility combinations) have been found in nepali healthcare facilities, including drug outlets. regarding prescription behavior, even in rural areas of india, the proportion of brand name prescriptions was high (aravamuthan, arputhavanan, subramaniam, & chander, ) . other common prescription problems include the lack of information, illegible handwriting, and various errors (e.g., prescription errors, dispensing errors, and improper labeling related to particular standards or requirements) (hussain & mohamed ibrahim, ; syhakhang, stenson, wahlström, & tomson, ) . pharmacy hours vary: typically, some pharmacies are open for approximately h (e.g., in malaysia), while others offer -h services (e.g., in qatar). in some countries (e.g., nepal and sudan), pharmacy hours and operations can be affected by the availability of reliable electrical power supply. some countries do not have conveniently located pharmacy outlets, and customers might have to walk for hours to reach one. some pharmacies lack proper facilities (e.g., a private room for patient counseling), space, reference resources (e.g., drug information), and/or quality medication (e.g., substandard and counterfeit and irrational fixed-dose combinations); have a poor layout, impractically arranged products, and/or disorganization issues; and/or keep and sell expired or almost expired items. developing countries also suffer from an insufficient number of pharmacists. in addition, for economic reasons, pharmacists prefer to work or set up their pharmacies in urban areas rather than in rural areas (smith, (smith, , . in addition, some pharmacists are hard to find in pharmacies ("the invisible pharmacist"), and patients/customers have to rely on pharmacy assistants/technicians (amin & chewning, ) . most of the time, these staff have no proper professional qualifications and lack important skills and knowledge. even worse, some community pharmacists lack particular competencies and communication skills, have no or few business skills, and do not have up-to-date knowledge. in some cases, pharmacists do not comply with regulations (e.g., selling antibiotics or psychotropic drugs without a prescription), and they often fail to assume responsibility for pharmaceutical care. in the eyes of the consumers, community pharmacists are always regarded as businesspeople rather than as healthcare professionals. community pharmacists must strike a balance between professional and business responsibilities. having both qualities, i.e., having a high level of professionalism and an excellent business sense, should not be so difficult. how these two aspects influence the health and well-being of individuals and society is what matters. the services provided by community pharmacists have been reported to focus more on their distributive function (e.g., basic medication dispensing and sales), not the expected proper medication dispensing practice mentioned above (wiedenmayer et al., ) . most of the time, pharmacists provide no advice/counseling; rarely interact with patients and physicians; make no referrals; lack or have few medicines due to poor planning and estimation/quantification; have no records of patients/clients or the medicines dispensed; use little to no technology; mix and prepare medications in the pharmacy rather than according to standards, for example, us or british pharmacopeia (compounding or extemporaneous dispensing); and do not provide drug information that could help reduce medication misadventures. in , the malaysian pharmaceutical society introduced its benchmarking guidelines for community pharmacies. the society sought to raise the standards of practice. unfortunately, a study reported that the level of awareness of these guidelines was low and that only around % of the pharmacies complied with them (siang, kee, gee, richard, & see hui, ) . the quality of the pharmacy education system has been affected. some countries lack colleges with pharmacy degrees. even if adequate, these colleges often lack quality curricula; the syllabi are out of date and do not cater to the present needs of the healthcare system. in addition, colleges lack staff; even if they have enough staff, they lack quality staff/faculty with appropriate qualifications or expertise. the pharmacy workforce is not carefully planned according to the country's needs. some countries do not have pharmacy associations, which could provide professional leadership, and some even are unable to provide continuing education for pharmacy staff. another critical problem is that there are very few policy makers and regulators who understand the system, who are committed and motivated, and who have sufficient technical know-how to solve the problems. in addition, many countries have a corrupt system and authorities; a weak and unstable government and economy; problems with bureaucracy, middlemen, profits, etc. that affect the final retail price, potentially making it too high for consumers; no or few effective price containment strategies/polices, which have resulted in unaffordable prices (khatib et al., ) , especially for the poor and others in need. due to the lack of an attractive salary and benefits, pharmacists have migrated to other countries for better life and career opportunities. as such, nonpharmacists are allowed to own and operate pharmacies in developing countries. the image of the pharmacist and the profession very much depends on customer satisfaction. a study conducted in nigeria showed that customers experienced moderate service satisfaction. customers were mostly dissatisfied with healthcare services that related to pharmaceutical care activities (oparah & kikanme, ) . in a patient satisfaction survey conducted in the united arab emirates (uae), scores were significantly lower than published data, suggesting that patients' expectations of community pharmacy services have not been met there (hasan et al., ) . dhote, mahajan, and mishra ( ) mentioned that the rise of pharmaceutical care services must be accelerated based on the rapid changes in consumers' expectations. best practices can be adopted and adapted according to a country's needs and conditions. does "one size" really fit all? is "comparing apples and oranges" difficult? adopting % of one country's practices in another country is unwise. many factors need to be considered. no country has a perfect system; however, community pharmacists in developing countries can definitely learn from at least one practice or service. according to brodie ( ) , the traditional role of dispensing medications has been expanded. pharmacists should be both health generalists and health specialists, which will have an impact on public health. even the american public health association ( ) supports the pharmacists' role in public health. should community pharmacists move beyond their traditional role? even when dispensing medicines through paper-based prescription services, pharmacists should comply with some fundamental standards. safety issues must be considered when dispensing medications. the pharmacy board of australia published guidelines for medication dispensing (i.e., guidelines for scanned and faxed prescriptions and steps to take when handling internet or mail-order dispensing); guidelines for dispensing extemporaneous medications; guidelines when handling errors (e.g., dispensing errors); guidelines for appropriate medication labeling; guidelines for patient counseling, privacy, and confidentiality; and pharmacy technicians' functions, responsibilities, and competencies (pharmacy board of australia, n.d.). in addition, for pharmacies that use electronic and computer systems, the royal pharmaceutical society of great britain (n.d.) has provided several guidelines and principles for good dispensing and appropriate dispensing procedures (e.g., professional checking, medication substitution, and labeling). malaysia, a developing country, has also developed guide to good dispensing practice (malaysian pharmaceutical services division, ) . these guidelines aim to have both public and private facilities dispensing medications according to the law and guidelines, which may ensure that patients receive the correct medications, adherence is improved, adverse effects are minimized, and errors are avoided. the document's contents relate to processing prescriptions, preparing medications, labeling, recoding, and issuing medications to the patient. in geographical areas where no pharmacists are available, a guide about managing medicines would be a handy document indeed (andersson & snell, ) . in some countries, community pharmacists are ready to provide extended services (or cognitive pharmaceutical services). according to cipolle, strand, and morley ( ) , cognitive pharmaceutical services entail the pharmacist's use of specialized knowledge to help patients or health professionals and promote effective and safe drug therapy. these services are simply "clinically oriented activities intended to improve medication prescribing and use" (farris, kumbera, halterman, & fang, ) . why are pharmacy practices still outdated in some countries? what are the barriers to quality community pharmacy services? are pharmacists reluctant to move forward? the lack of time, reimbursement, recognition, cooperation with general practitioners, documentation, networking; the location of services within the pharmacy premises; the attitudes of customers and pharmacists; the pharmacy owner's involvement (or lack thereof); the daily organization of services; and customer recruitment for such services are among the barriers to the successful implementation of extended services (cognitive services) (garrett & martin, ; gastelurrutia et al., ; hopp, sørensen, herborg, & roberts, ; rossing, hansen, & krass, ) . in some countries, pharmacists have moved away from product-oriented services toward service-oriented and then patient-oriented services, increasingly emphasizing the patient's health outcomes (the economic, clinical, and humanistic outcomes model) (drabinski, ; kozma, reeder, & schulz, ) . outcomes refer to the consequences (results) of interventions that are made to achieve therapeutic goals. outcomes can have economic, social/behavioral, or physiological characteristics. when community pharmacists are serving the public, in addition to health outcomes, at least four important parameters should be monitored: accessibility, availability, affordability, and acceptability. when patients benefit from the medications that they take, their health improves, which ultimately reduces costs (wiedenmayer et al., ) . the scope of pharmacy practice now includes patient-centered care-with all the cognitive functions of counseling, providing drug information, and monitoring drug therapy-and the technical aspects of pharmaceutical services, including medication supply management, as well as people-or public-centered care. community pharmacies can offer comprehensive healthcare services, including advanced and enhanced services. such services include the rational use of medicines; medication adherence; self-management clinics for group of patients with chronic diseases (e.g., diabetes mellitus, hypertension, and asthma); medication therapy management; screening and monitoring; education for enhancing medication adherence; encouraging and educating patients to receive their recommended immunizations and those for infants; home healthcare services; partnership in palliative care teams; drive-through facilities; mail and internet orders of medicines; rural and remote area services; mobile pharmacy; helping patients with special needs; public health and primary healthcare services (e.g., hiv/aids and drug abuse treatment); distributing literature and educating regarding life style change for stress reduction, proper nutrition, and exercising; collaboration with other healthcare professionals during disease outbreaks (e.g., ebola virus disease, severe acute respiratory syndrome, middle-east respiratory syndrome, and zika virus disease); involvement in an unwanted medicines program; health promotion (the process of enabling people to increase their control over-and to improve-their health, e.g., smoking cessation, obesity management, and diabetic self-management); drug therapy problems (defined as "[a]n undesirable event, a patient experience that involves, or is suspected to involve drug therapy, and that actually or potentially, interferes with a desired patient outcome" (cipolle et al., ; strand, cipolle, morley, ramsey, & lamsam, ) ); and pharmaceutical public health services. pharmaceutical public health has been defined as follows: the application of pharmaceutical knowledge, skills and resources to the science and art of preventing disease, prolonging life, promoting, protecting and improving health for all through the organized efforts of society. pharmacists could also provide public services, such as local guidelines and treatment protocols, medication use review and evaluation, national medicine policies and essential medicine lists, pharmacovigilance, needs assessment, and pharmacoepidemiology (wiedenmayer et al., ) . pharmacists should be at the front line to promote safe sex, birth control education, advice on nursing babies, and caring for elderly parents and relatives. in addition, pharmacists could work with local authorities in the direction of a cleaner and safer environment (air, water, and ground) and for safe food handling. pharmacists should only carry in stock and sell products with proven medical value, not selling tobacco products, and not supplements and homeopathic medicines that have no clear scientific evidence of safety and effectiveness. the literature has shown that community pharmacists in some countries have had a positive impact on public health. first, training and education programs have been able to enhance the knowledge and practices of pharmacists. continuing education programs, especially if mandatory, also play a significant role. second, pharmacy colleges have improved by incorporating relevant courses and topics into the syllabi for undergraduate pharmacy programs. third, strong, motivated, and uncorrupted pharmacy authorities/regulatory agencies have been able to improve community pharmacy practices because of their concern, motivation, and effort to make necessary improvements. to progress and gain society's acceptance, community pharmacists must acknowledge the following challenges in healthcare systems: � one-third of the world's population is known to lack regular access to essential medicines. for many people, the cost of medication is a major constraint. those hardest hit are patients in developing and transitional economies, where % to % of medicines are out-of-pocket expenses (who, ) . the burden falls most heavily on the poor, who are not adequately protected by current policies or by health insurance. � healthcare workers, including community pharmacist, are in short supply, especially in lmics (who, ) . � some countries are eager to introduce and establish a doctor of pharmacy (pharmd) degree in pharmacy colleges, but due to several reasons, they have failed to produce competent graduates who can apply clinical knowledge in practice or who can distance the practice from its traditional role. � the logistical aspects of distribution, often seen as the pharmacist's traditional role (i.e., the "count and pour, lick and stick pharmacy"), represent another challenge. � in terms of medication quality, studied medication samples have failed quality control tests (msh, ) , and substandard and counterfeit medications are highly likely to be on pharmacy shelves. � another major challenge is ensuring that medicines are used as advised or instructed; more than half of all prescriptions are incorrect, and more than half of the people who are prescribed with medications fail to take them correctly. medication adherence can be affected if the medication is unavailable or unaffordable or if the instructions given are not understood or remembered. furthermore, a patient's confidence or trust in the pharmacist or the medications prescribed may also affect adherence. � especially in economically deprived communities, self-medication with either modern or traditional medicines is becoming common practice. individuals resort to self-medication when healthcare services become more unaffordable and inaccessible (hughes, mcelnay, & fleming, ) . the situation deteriorates when prescription medicines can be easily obtained over the counter. community pharmacists could play a role in mitigating the risks of selfmedication (bennadi, ) . given the list of pharmacist-, pharmacy-, and practice-related issues above, are pharmacists still needed in the community and in the healthcare system? if community pharmacists still perform the basic function of medication dispensing or if a country lacks pharmacists, could we simply have medicine vending machines (i.e., a self-service technology) across the country (adams, ; poulter, ) ? these machines could provide customers access to otc drugs, nondrug items, and information, thereby supporting the self-care concept (steinfirst, cowell, presley, & reifler, ) . this technology could be argued to have an adverse effect on customers. for example, the buying and selling process lacks the "human touch," or customers leave the pharmacy without information or take medication incorrectly due to a lack of quality information. however, what is the difference when the same customers visit pharmacies with "invisible pharmacists"? do pharmacists just count pills? if community pharmacists are hesitant or refuse to change, these vending machines will put them out of business. for countries searching for cost-cutting strategies, this technology might be a solution. to be effective healthcare team members, community pharmacists need skills and abilities that will enable them to assume many different functions. who introduced the concept of the "seven/eight-star pharmacist," which the international pharmaceutical federation (fip) adopted in in its policy statement on good pharmacy education practice to outline the caregiver, decision-maker, communicator, manager, lifelong learner, teacher, and leader roles of the pharmacist. the pharmacist's function as a researcher has since evolved, and all these roles have been addressed in the competence standards (who, , pp. - ) . community pharmacists have to make efforts to move from being drug compounders and dispensers to being pharmaceutical care providers and medication experts; their role and function should focus on patient-centered care rather than products and profits. community pharmacists must equip themselves with adequate knowledge and skills and be responsible for ensuring that, irrespective of the medications provided and used, quality products are selected, procured, stored, distributed, dispensed, and administered to enhance patients' health and do them no harm. relevant pharmacy authorities should provide more support, training, and development for community pharmacies to help their pharmacists deliver high-quality services. pharmacy associations could organize programs in collaboration with pharmacy colleges and could involve regional or international experts if affordable. nonprofit international organizations, such as who and management sciences for health (msh), could assist lmics in this matter. in addition, some chain pharmacies could implement monthly programs. community pharmacists must be involved in cpd; individual pharmacists are responsible for the systematic maintenance, development, and broadening of their knowledge, skills, and attitudes to ensure their continued competence as professionals throughout their careers. community pharmacists (with the help of academics from pharmacy colleges, if required) must conduct research to document outcomes and impacts (e.g., accessibility, effectiveness, and positive perceptions of the experience); research must be conducted to assess the minimum standards and quality of community pharmacies and to provide evidence-based practice information. the numbers of published studies from developing countries are very low compared with those from developed countries. managerial and educational interventions are needed to improve the practice. community pharmacists could obtain inputs/ideas and explore the perceptions of community pharmacy staff-in addition to customers and patients-regarding aspects of service quality. these inputs could then perhaps be used to improve the services offered to customers. some pharmacists are able to use information technology to enhance pharmacy and pharmaceutical services; pharmacists in some other countries find doing it so problematic-due to a very basic infrastructure or the lack of basic competencies, among others. finally, who (wiedenmayer et al., ) and other sources have provided a guide and systematic approach for delivering pharmacy patient-centered care and good pharmacy and dispensing practice. public health pharmacy interventions, patient-centered care, rational medication use, and effective medication supply management are key components of an accessible, sustainable, affordable, and equitable healthcare system that ensures the efficacy, safety, and quality of medications. the customer's (patient's) expectations are rapidly changing; customers are becoming more aware of their healthcare needs. customers now demand better quality care and more attention to maintain or improve their overall health. evidence has shown that challenges and gaps exist in community pharmacy practice. in developing countries, the functions of community pharmacists must be redefined and reoriented. a paradigm shift in the mind-set and practices of pharmacists is urgently needed. • although the overall level of community pharmacy services provided in developing countries does not meet the public's expectations, gradual progress has been observed. • the number of trained community pharmacists is inadequate; their distribution is unbalanced; and, in some countries, individuals without the professional pharmacy degrees are allowed to work in pharmacies. thus, pharmacy authorities, policy makers, and educators must collaborate to fix these problems and make improvements. • due to the high prevalence of chronic diseases and the need to improve public health and wellbeing, community pharmacists must continue to be competent in their professional and business roles; pharmacists should expand the role in delivering wellness services (e.g., disease-oriented pharmaceutical care) that go beyond filling prescriptions. • many developing nations do not have effective and efficient regulations, guidelines, policies, governmental support, or electronic patient records and databases in community pharmacies to help establish and implement clinical, cognitive, and extended pharmacy services. • community pharmacists should establish benchmark best practices-at the very least among countries with similar economies and levels of development. role of a pharmacist prescription drug vending machines now being installed on college campuses across america community pharmacy in warri, nigeria -a survey of practice details antibiotics dispensing for urtis by community pharmacists and general medical practitioners in penang, malaysia: a comparative study using simulated patients pharmaceutical care in community pharmacies: practice and research in peru pharmacies without pharmacists: absenteeism plagues pharmacies in developing countries where there is no pharmacists: a guide to managing medicines for all health workers assessment of current prescribing practices using world health organization core drug use and complementary indicators in selected rural community pharmacies in southern india chapter concepts of health and illness. public and population health community pharmacists' attitudes towards use of medicines in rural india: an analysis of current situation self-medication: a current challenge pharmacy's societal purpose pharmaceutical care practice opportunities and challenges in pharmacy profession in developing countries like india: an overview strategies to demonstrate the value of pharmacists' cognitive services community pharmacy practice in china: past, present and future outcomes-based pharmacist reimbursement: reimbursing pharmacists for cognitive services (part of a -part series) pharmacy practice in developing countries: achievements and challenges the asheville project: participants' perceptions of factors contributing to the success of a patient self-management diabetes program facilitators for practice change in spanish community pharmacies dispensing practice in the community pharmacies in the turkish republic of northern cyprus the practice of otc counseling by community pharmacists in parana assessing patient satisfaction with community pharmacy in the uae using a newly-validated tool unresolved issues in the future of pharmacy opportunities and responsibilities in pharmaceutical care implementation of cognitive pharmaceutical services (cps) in professionally active pharmacies benefits and risks of self-medication management of diarrhoea cases by community pharmacies in cities of pakistan using the potentials of community pharmacies to promote rational drug use in pakistan: an opportunity exists or lost medication counselling and dispensing practices at community pharmacies: a comparative cross sectional study from pakistan assessment of disease management of acute respiratory tract infection at community pharmacies through simulated visits in pakistan compliance with legal requirements at community pharmacies: a cross sectional study from pakistan availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the pure study data economic, clinical, and humanistic outcomes: a planning model for pharmacoeconomic research analysis of dispensing practices at community pharmacy settings in ambo town chapter quality assurance for pharmaceuticals strengthening pharmacy practice in vietnam: findings of a training intervention study how do community pharmacists in qatar respond to patients presenting with symptoms of acute respiratory tract infections evaluating community pharmacy practice in qatar using simulated patient method: acute gastroenteritis management consumer satisfaction with community pharmacies in are sudanese community pharmacists capable to prescribe and demonstrate asthma inhaler devices to patrons? a mystery patient study pharmacy board of australia. guidelines for dispensing of medicines prevalence of fixed dose drug combinations in nepal: a preliminary study medicine vending machines that dispense prescriptions hours a day go on trial barriers and facilitators in pharmaceutical care: perceptions and experiences among danish community pharmacies practice guidance: good dispensing guidelines -england community pharmacy role/service definition grid implementation of the benchmarking guidelines on community pharmacies in malaysia pharmacy practice community pharmacy in ghana: enhancing the contribution to primary health care vending machines and the self-care concept drug-related problems: their structure and function the quality of public and private pharmacy practices. a cross sectional study in the savannakhet province, lao pdr policy statements adopted by the governing council. the role of the pharmacist in public health pharmaceutical care in community pharmacies: practice and research in estonia pharmaceutical public health: the end of pharmaceutical care? jointly sponsored by the world health organization and the united nations children's fund. geneva: world health organization health reform and drug financing, selected topics, health economics and drugs, dap series no who global strategy on people-centred and integrated health services the role of the pharmacist in the health-care system -preparing the future pharmacist: curricular development people at the centre of health care: harmonizing mind and body, people and systems constitution of the world health organization. geneva: world health organization global strategy on human resources for health: workforce health promotion: a discussion document on the concept and principles: summary report of the working group on concept and principles of health promotion developing pharmacy practice: a focus on patient care. who (and fip) the untilled field of public health. modern medicine, , . who. the world health organization quality of life assessment (whoqol): position paper from the world health organization further reading chapter : comparative analysis and conclusion key: cord- -bsvlr fk authors: siriwardhana, yushan; gür, gürkan; ylianttila, mika; liyanage, madhusanka title: the role of g for digital healthcare against covid- pandemic: opportunities and challenges date: - - journal: nan doi: . /j.icte. . . sha: doc_id: cord_uid: bsvlr fk covid- pandemic caused a massive impact on healthcare, social life, and economies on a global scale. apparently, technology has a vital role to enable ubiquitous and accessible digital health services in pandemic conditions as well as against “re-emergence” of covid- disease in a post-pandemic era. accordingly, g systems and g-enabled e-health solutions are paramount. this paper highlights methodologies to effectively utilize g for e-health use cases and its role to enable relevant digital services. it also provides a comprehensive discussion of the implementation issues, possible remedies and future research directions for g to alleviate the health challenges related to covid- . the recent spread of coronavirus disease (covid- ) due to severe acute respiratory syndrome coronavirus (sars-cov- ) [ ] has caused substantial changes in the lifestyle of communities all over the world. by the end of june at the time of this writing, over eleven million positive cases of covid- were recorded, causing over , deaths. countries have been facing a number of healthcare, financial, and societal challenges due to the covid- pandemic. overwhelmed healthcare facilities due to rapid growth of new covid- patients, are experiencing interruptions in provision of regular health services. moreover, healthcare personnel are also becoming vulnerable to covid- and this is taxing the healthcare resources even more. to cease the wide spread of the virus, governments impose strict restrictions and control on travel within and between countries, negatively affecting the economies. while the remote work was considered as an alternative with limitations, certain jobs became obsolete. the increased unemployment is a burgeoning problem even for strong economies. apart from that, government expenditure on unemployed workforce, losing income from sectors associated with tourism such as airlines, hotels, local transport, and entertainment were major challenges for the economies. governments had to introduce new guidelines on social distancing to prevent the spread of the virus. this resulted in closing schools, isolating cities and even restricting public interactions, affecting the regular lifestyle of people. such disruption could lead to unprecedented _______________________ *corresponding author email addresses: yushan.siriwardhana@oulu.fi (yushan siriwardhana), gueu@zhaw.ch (gürkan gür), mika.ylianttila@oulu.fi (mika ylianttila), madhusanka.liyanage@oulu.fi, madhusanka@ucd.ie (madhusanka liyanage) consequences such as losing physical and mental well-being. maintaining the societal well-being during the covid- era is therefore a daunting task. the technological advancement is one of the key strengths in the current era to overcome the challenging circumstances of covid- outbreak. the timely application of relevant technologies will be imperative to not only to safeguard, but also to manage the post-covid- world. the novel ict technologies such as internet of things (iot) [ ] , artificial intelligence (ai) [ ] , big data, g communications, cloud computing and blockchain [ ] can play a vital role to facilitate the environment fostering protection and improvement of people and economies. the capabilities they provide for pervasive and accessible health services are crucial to alleviate the pandemic related problems. g communications present a paradigm shift from the present mobile networks to provide universal high-rate connectivity and a seamless user experience [ ] . g networks target delivering x higher mobile data volume per area, x higher number of connected devices, x higher user data rate, x longer battery life for low power massive machine communications, and x reduced end-toend (e e) latency [ ] . these objectives will be realized by the key technologies such as mmwaves, small cell networks, massive multiple input multiple output (mimo) and beamforming [ ] . by utilizing these technologies, g will mainly support three service classes i.e. enhanced mobile broadband (embb), ultra reliable and low latency communication (urllc) and massive machine type communication (mmtc). the novel g networks will be built alongside fundamental technologies such as software defined networking (sdn), network function virtualization (nfv), multi-access edge computing (mec) and network slicing (ns). sdn and nfv enable programmable g networks to support the fast deployment and flexible management of g services. mec extends the intelligence to the edge of the radio network along with higher processing and storage capabilities. ns creates logical networks on a common infrastructure to enable different types of services with g networks. these g technologies will enable ubiquitous digital health services combating covid- , described in the following section as g based healthcare use cases. however, there are also implementation challenges which need to mitigated for efficient and high-performance solutions with wide availability and user acceptance as discussed in section . in this work, we elaborate on these aspects and provide an analysis of g for healthcare to fight against the covid- pandemic and its consequences. capabilities of g technologies can be effectively utilized to address the challenges associated with covid- presently and in the post covid- era. existing healthcare services should be tailored to fit the needs of covid era while developing novel solutions to address the specific issues originated with the pandemic. in this section, the paper discusses several use cases where g is envisaged to play a significant role. these use cases are depicted in figure and the technical requirements of use cases are outlined in table . telehealth is the provision of healthcare services in a remote manner with the use of telecommunication technologies [ ]. these services include remote clinical healthcare, health related education, public health and health administration, defining broader scope of services. telemedicine [ ] refers to remote clinical services such as healthcare delivery, diagnosis, consultation, treatment where a healthcare professional utilizes communication infrastructure to deliver care to a patient at a remote site. telenursing refers to the use of telecommunication technologies to deliver nursing care and conduct nursing practice. telepharmacy is defined as a service which delivers remote pharmaceutical care via telecommunications to patients who do not have direct contact with a pharmacist. (e.g. remote delivery of prescription drugs). telesurgery [ ] allows surgeons to perform surgical procedures over a remote distance. all these healthcare related teleservices are highly encouraged in post-covid- period due to multiple reasons. lack of resources (i.e., hospital capacity, human resources, protective equipment) in healthcare facilities due to existing covid- patients, social distancing guidelines imposed by authorities, requirements of maintaining the regular healthcare services adhering to the new guidelines imposed by the healthcare administrations and the need to minimize the risk of healthcare professionals getting exposed to covid- are factors motivating teleservices related to healthcare. these teleservices sometimes have strict requirements and call for sophisticated underlying technologies for proper functionality. as an example, a telemedicine followup visit between the patient and the doctor, would require k/ k video streaming with low-latency and low jitter. telehealth based remote health education programs should be accessible to the students from anywhere via an internet connection having a proper bandwidth. monitoring the patients via telenursing also requires uninterrupted hd/ k video stream between the patient and the nurse. remote delivery of drugs is possible via unmanned ariel vehicles (uav), which requires assured connectivity with the base station to send/receive control instructions without delays. extreme use cases like telesurgery requires ultra-low latency communication (less than ms e e latency) between the surgeon and the patient, connectivity between number of devices such as cameras, sensors, robots, augmented reality (ar) devices, wearables, and haptic feedback devices [ ] . the future g networks will use the mmwave spectrum, which leads to the deployment of ultra-dense small cell networks, including the network connectivity for indoor environments. technologies like massive mimo combined with beamforming will contribute for providing extremely high data rates for large number of intended users. these technologies together provide a better localization for indoor environments [ ] . these g technologies realize the embb service class which facilitates the transmission of k/ k videos between the healthcare professional and the patient, irrespective of the location of access. the new radio access technology developed by the g networks, also known as g new radio (nr) supports urllc. the urllc service class helps to realize the ultra-low latency requirements of telesurgery applications. a local g operator (l go) has its core and access network deployed locally on premises, serves the healthcare facility with multiple base stations deployed both outdoors and indoors to provide connectivity for case specific needs. this deployment is beneficial for telesurgery use case to achieve ultra-low latency, given that there is a requirement of surgeon and patient being in separate rooms due to the pandemic situation. mec servers deployed at the g base stations can be utilized to deploy the control functions for uavs for proper payload deliveries. the fundamental design changes in g networks will enable the communication of large number of iot devices, which usually transfer less data compared to human activities such as streaming. these mmtc services provide the support to g enabled medical iots (miots) that can be used to monitor and treat remote patients. mmtc will connect and enable communication between heterogeneous devices into the g network so that they can operate in synchronicity. a sensor in a wearable device of the patient can immediately sends a signal to the remote nurse via g network so that the nurse can activate a special equipment in the patient's room using the mobile device. the use of g technologies in a hospital environment for telehealth use cases is illustrated in figure . the spread of covid- disease demands the rapid launching of new healthcare services/applications, change the way present healthcare services are provided [ ] , integrate modern tools such as ai and machine learning (ml) in the data analysis process [ ] . a new application can collect the data of covid- patients from different healthcare centers, upload the data to a cloud server and make the information available to public so that others can rely on the information for different purposes. a live video conferencing based interactive applications which enable healthcare professionals to discuss with patients and help them is another example [ ] . other applications would perform regular health monitoring of patients such as followup visits, provide instructions on medical services, and spread knowledge on present covid- situation and upto date precautions. the difficulty during the pandemic was that there was a need to automate most of the regular work to minimize the interaction between people and new application development needs were also sudden. this calls for a flexible network infrastructure which supports the development of such applications within a short period of time. in contrast to the present g networks, g supports the creation of new network services as softwarized network functions (nfs) by utilizing sdn and nfv technologies. these nfs can be hosted at the cloud servers, operator premises, or in the edge of the network based on the application demands. mec servers equipped with storage and computing power and reside at the edge of the radio network, will be a suitable platform to host these applications. the deployment of such applications will be more flexible in g networks because of the sdn and nfv. bringing the nfs towards the edge eliminates the dependency of the infrastructure beyond the edge, making the applications more reliable. increasing the capacity of the g network is much easier because the network itself is programmable. g networks are capable of deploying network slices which create logical networks to cater the services with similar type of requirements such as iot slice and low latency slice, thereby serving applications with guaranteed service levels. a surge in demand for personal protective equipment (ppe), ventilators and certain drugs was observed at the beginning of the covid- spread, causing an imbalance of the regular supply chains [ ] . manufacturing plants were unable to maintain the regular production due to the shortage of raw materials and labor force, therefore they were not capable of responding to the increased demand for the goods. the supplies of finished products were also delayed due to transport restrictions and there were no proper alternative distribution mechanisms so that the people who are really in need would receive them. n masks, hand sanitizers, and regular medicine are some of the goods where this imbalance of supply was often seen. those who reacted quickly could stock items in surplus while others who are in need did not receive them. donations to the victims were not always distributed in a fair manner because of the absence of centralized management systems. delivery of the items to the final consumer was a concern due to the risk of covid- spread and the restrictions imposed by the authorities to limit the physical contact. it is a challenge for the governments, healthcare authorities, distributors to implement proper mechanisms to manage the supply chains of healthcare items in the covid- period. to address the issues in healthcare related supply chains, industries can adopt smart manufacturing techniques equipped with iot sensor networks, automated production lines which dynamically adapt to the variations in demand, and sophisticated monitoring systems. iot based supply chains could be used to properly track the products from the manufacturing plant to the end consumer, i.e. connected goods. uav based automated delivery mechanisms are specially suited in the covid- situation to deliver medicine, vaccines, masks to the end consumer minimizing the physical contact. g supports direct connectivity for iot and mmtc between iot devices. this will fuel the possibility to use large amount of iot devices to increase the efficiency of supply chains. deployment l gos to serve the needs of industries is a better way to integrate iot sensors, actuators, robots directly into g network enabling a g based smart manufacturing system. the proper network connectivity for the sensors, actuators, robots in the manufacturing plants will be enabled by the mmwave g small cells deployed indoors. massive mimo will provide connectivity for a large number of devices and beamforming technique ensures a better quality of the network connection. the direct connectivity of goods into the g systems makes the supply chains more transparent. mec integrated with g, can be used to process the data locally to improve the scalability of the systems as well as security and privacy of collected data. moreover, mec integrated with g can easily be used to implement decentralized solutions via blockchain [ ] , [ ] . the delivery of items to the final destination can be performed via beyond lineof-sight (blos) uav guided by the g network. this could minimize unnecessary interactions in covid- period and reduce human efforts. real-time data is available for the authorized users for monitoring and tracking, which increases the transparency of the operation. covid- positive patients with mild conditions are usually advised for self-isolation to prevent further spread. while self-isolation is a better alternative to manage the capacity of healthcare facilities, the self-isolating individuals should be properly monitored to make sure that they follow the self-isolation guidelines. the challenge is to track every movement of the patient, which is currently impossible. in an event of a violation of self-isolation guidelines, control instructions should be sent. mobile device based selfisolation monitoring is possible via an application which sends random gps data of patient's mobile phone to a cloud server. wearable devices attached to the patient's body use their sensors to measure the conditions of the patient and upload the data via the mobile phone. uav based solutions can monitor the conditions of the patients from a distance. uavs can monitor body temperature via infrared thermography and identify the person via face recognition algorithms. moreover, contact tracing of identified positive cases is extremely important [ ] . however, present contact tracing mechanisms involve significant human engagement and consist of a lot of manual work. this prevents the identification of all the possible close contacts and hinders the effectiveness of the contact tracing. manual tracing does not guarantee that all the possible close contacts are identified. bluetooth low energy (ble) based contact tracing applications use ble wearable devices, which advertise its id periodically so that other compatible devices in close proximity can capture the id and store with the important details such as timestamp, gps location data (optionally). once an infected covid- patient is detected, the ble solution provides the ids of the close contacts over a defined period. ble based solutions identify the contacts in the range of few meters, whereas pure gps based solutions do not have that accuracy. role of g mmtc in g is responsible for massive connectivity of heterogeneous iot devices such as sensors, wearables, and robots. the small cell networks equipped with mimo and beamforming in g will ensure better connectivity and positioning including indoor environments. hence, iot devices directly connected to g network can be effectively used to monitor the compliance of self-isolation. instead of using general mobile device data, the patients can be attached with a low power wearable devices which transfer data via ble technology. those sensory data can be updated to the cloud via the g network and the authorized parties can monitor the behavior of the patient. a similar concept can be applied to contact tracing where the wearable ble devices collect data of nearby devices and upload to the cloud via g network. once a patient is tested positive, all the close contact details are already in the cloud and they are notified for proper safety measures such as self-isolation. mec servers deployed at the g base stations are useful to increase the scalability of the operation as the resource demand increases. allocating a separate network slice for contact tracing data transfer is a better approach to assure the quality of service (qos) and strengthen the privacy and security of the data. despite the use-cases for g concerning healthcare and the fight against covid- , there are also imminent challenges ranging from technical ones such as scalability to socio-economic ones including technology acceptance. the impact of pertinent deployment challenges on each use case is depicted in table . j o u r n a l p r e -p r o o f journal pre-proof a video recording of a telemedicine session may contain personal information which the patient would like to disclose only to the doctor. in addition, automated contact tracing applications aggregate sensitive location data without the owners' knowledge. sharing such sensitive user data with unauthorized parties such as third-party advertisers is a serious privacy violation [ ] . in addition, privacy protection is a legal requirement, which is posed by various legal frameworks such as gdpr [ ] and health insurance portability and accountability act (hipaa) [ ] . to address the privacy challenge, solutions like privacy by-design [ ] , software defined privacy [ ] have to be deployed with g health applications already at the design phase. privacy-by-design relies on the notion that that data controllers and processors should be proactive in addressing the privacy implications of any new or upgraded system, procedure, policy or data-sharing initiative, not at the later stages of its life-cycle, but starting from its planning phase [ ] . the developed e-health solutions in g should consider the entire life-cycle of health data when protecting to protect privacy, access control methods managing how different parties access information are necessary. edge computing is beneficial to minimize data transmissions through different network elements and enable local processing, improving privacy aspects [ ] . furthermore, users of e-health technology should be made fully aware of what they are consenting to regarding data sharing and processing when they are using such digital solutions. similarly, transparency in the form of informing users of potential privacy risks are effective to improve the adoption of e-health solutions [ ] . attempts by adversaries to attack the databases containing sensitive information pose security risks. the importance of e-health systems exacerbates the impact of attacks on the availability requirement. the integration of miot increases security risks of healthcare systems. such low-end devices are comparably easy to hack and vulnerable to denial-of-service (dos) attacks. massive amount of connected devices increases the number of entry points for attackers to perform unauthorized operations, i.e. increases the attack surface, on the healthcare system [ ] . lightweight and scalable security mechanisms must be designed to secure miots. adequate security mechanisms are crucial to address the limited capabilities of constrained sensors, as well as the additional vulnerabilities if part of the security functions are offloaded to the cloud. for the digital health services, widespread automation, data analytics and smart control requires ml and ai techniques in g systems. encrypted data transmission and distributed security solutions such as blockchain can prevent attackers gain access to the network and protect the collected user data of different premises. the employed security mechanisms and algorithms should support continuous updates with minimal effort to adapt to discovered vulnerabilities and emerging security threats. regime a rapid deployment of new healthcare applications will add extra traffic as well as increase the number of g users who access such services. this will lead to increased network congestion. as an example, ar based applications used in telemedicine require high bandwidth and low latency. however, a congested network fails to satisfy the service levels for such applications. moreover, it is challenging to manage billions of miots. when a large number of iot devices generate ad-hoc data transfers, the network should be scalable to cope with the increased number of traffic events. the small data characteristics and intermittent connectivity of iot encumber the medium access and physical layers of access networks serving ehealth applications. ns in g with dynamic scalability is a possible solution to address this problem. the slices serve similar type of services and they can be made adaptive based on the various parameters such as priority of the service, present network traffic, available network resources, qos requirement, number of iot devices presently connected [ ] . deployment of virtual nf based on demand at the mec servers will provide a solution to the congestion due to sudden increase of localized demands. for improving scalability, edge computing systems and distributed clouds can perform visual processing on large computational capabilities like gpus and transmit the audiovisual outputs enriched with analytics results to mobile e-health devices. in this way, the impact from device limitations is elastically minimized while congestion towards core network is also mitigated. regarding the physical layer, phy techniques such as full beamforming technologies using a large number of antenna elements increase scalability, high frequency utilization efficiency and high-speed communication. network operators need to deploy these g based solutions as soon as possible. the limited deployment of g networks and limited availability of g devices will be an immediate problem for many countries. undoubtedly, the g proliferation is expected to be gradual in terms of network connectivity and capacity. the complexity and implementation issues of g devices including power consumption due to high frequency transmissions as well as multi-band support of upper and lower frequency bands complicate the device cost and production challenges. governments and networks operators should push forward their deployment plans. moreover, small scale g deployments such as l go networks [ ] should be encouraged to use in hospitals, manufacturing plants [ ] . purpose-built iot devices with a smaller but targeted capabilities for e-health use-cases can alleviate the complexity and cost issues regarding the deployment and commissioning of g systems. from the business perspective, offering a discount to mobile operators bidding in spectrum auctions in exchange for an improved coverage commitment can expedite the g deployment. for improving coverage in poorly served areas, some spectrum bands can be shared by different network providers. from the cost minimization perspective, ran sharing allows multiple operators to use the same radio access infrastructure and enables an easier coverage expansion for g. incidents such as destroying the cellular base stations [ , ] due to conspiracy theories linking new g mobile networks and the covid- pandemic [ ] , disrupts connectivity affecting the applications. however, network j o u r n a l p r e -p r o o f journal pre-proof connectivity and service continuity are critical for connected e-health solutions. g solutions may require the user to possess sophisticated level of technical literacy. however, many people lack such level of technical literacy. the provided ease of use is an important factor that supports or inhibits the implementation of e-health systems. health personnel is deterred from or resistant to using such new systems with additional complexity to their workflows, or requiring additional effort/time [ ] . furthermore, g devices are significantly more expensive, leading to a cost burden on users. experts and media have responsibility to clear out these inaccurate social beliefs with the support of civil society and governments. the applications can be made easier to use and to execute on average hardware and devices so that everyone can afford it and use the services. for e-health solutions supporting physician-patient interaction, an effective clinical decision support system must minimise the effort required by clinicians to receive and act on system recommendations. this requirement is extended to include ease of use for patients and their family members and other service users, or even health professionals be-sides clinicians, such as nurses [ ] . solutions for remote monitoring, contact tracing will result in legal issues unless the sensitive personal data is not properly handled. examples are contact tracing after the patient is recovered from covid- , collecting and storing unnecessary data from the personal devices. since access to healthcare is a right, if the technical solutions prevent people from obtaining timely healthcare or cause wrong diagnosis/treatment, that is an issue concerning fundamental rights. g-enabled smart devices for e-health will have a far reaching impact on manufacturers, service companies, insurers and consumers. such a situation could also lead to legal issues. adhering to the policies defined by standardization bodies such as eu statement on contact tracing [ ] prevents legal issues. standardisation and regulation must cover the whole range of healthcare technology chain from medical device technologies to software technologies, including sensors. obtaining legal advice before the deployment of different applications would also prevent the future legal issues. the traditional product liability limited to the form of tangible personal property should be extended to the correct functioning of network and services in e-health solutions. this is more challenging due to the complex environment of g. therefore, root-cause analysis techniques and pervasive monitoring functions are important [ ] . healthcare sectors of the countries were the first to affect due to the spread of covid- disease, facing numerous challenges. as the countries now have control mechanisms in place to minimize the spread of covid , they are reopening the economies so that the public can resume their regular lifestyle. to prevent any "re-emergence" of the disease, healthcare sectors of each country must be equipped with novel solutions to address any emerging j o u r n a l p r e -p r o o f challenges effectively. to this end, g technologies are crucial. g utilizes mmwave frequencies of the radio spectrum with small cell base stations which will provide better connectivity including indoor environments via its nr. massive mimo combined with beamforming will serve a large number of g devices/users with guaranteed data rates. these technologies deliver embb, urllc and mmtc service classes which enable the development of different types of services using g networks such as ar, uav communication, and collaborative robots. together with g, mec and ns will improve flexibility, scalability, guaranteed service levels and security for the applications. hence, solutions developed using g technologies serve various health related use cases such as telehealth, supply chain management, self-isolation and contact tracing, and rapid health services deployments. however, a wide range of implementation challenges such as privacy/security, scalability, and societal issues should be addressed before deploying such applications with full functionality. severe acute respiratory syndrome coronavirus (sarscov- ) and corona virus disease- (covid- ): the epidemic and the challenges smart home-based iot for real-time and secure remote health monitoring of triage and priority system using body sensors: multidriven systematic review role of biological data mining and machine learning techniques in detecting and diagnosing the novel coronavirus (covid- ): a systematic review a proposed solution and future direction for blockchain-based heterogeneous medicare data in cloud environment five disruptive technology directions for g scenarios for g mobile and wireless communications: the vision of the metis project what will g be? how about actively using telemedicine during the covid- pandemic? m-health solutions using g networks and m m communications transformation in healthcare by wearable devices for diagnostics and guidance of treatment single-and multiple-access point indoor localization for millimeter-wave networks realtime smart patient monitoring and assessment amid covid pandemic-an alternative approach to remote monitoring ai-driven tools for coronavirus outbreak: need of active learning and cross-population train/test models on multitudinal/multimodal data design and develop a video conferencing framework for realtime telemedicine applications using secure group-based communication architecture lessons from operations management to combat the covid- pandemic the role of blockchain in g: challenges, opportunities and research directions, in: nd g wireless summit ( g summit) how can blockchain help people in the event of pandemics such as the covid- ? a flood of coronavirus apps are tracking us. now it's time to keep track of them tactile-internetbased telesurgery system for healthcare . : an architecture, research challenges, and future directions g mobile and wireless communications technology survey on multi-access edge computing for internet of things realization ieee th vehicular technology conference the efficacy of contact tracing for the containment of the novel coronavirus (covid- ) g technology for augmented and virtual reality in education telepharmacy services: present status and future perspectives: a review for telehealth to succeed, privacy and security risks must be identified and addressed eu data protection rules department of health & human services, health insurance portability and accountability act of (hipaa a systematic literature review on privacy by design in the healthcare sector ieee international conference on cloud engineering workshop (ic ew) privacy by design: informed consent and internet of things for smart health privacy techniques for edge computing systems first, design for data sharing inspire- gplus: intelligent security and pervasive trust for g and beyond networks dynamic network slicing for multitenant heterogeneous cloud radio access networks micro operators to boost local service delivery in g micro-operator driven local g network architecture for industrial internet mast fire probe amid g coronavirus claims at least uk phone masts vandalised over false g coronavirus claims covid and the g conspiracy theory: social network analysis of twitter data g-ppp white paper on ehealth vertical sector statement on essential principles and practices for covid- contact tracing applications this work is partly supported by the european union in response g (grant no: ) and the academy of finland in genesis (grant no. ) key: cord- -h l yy z authors: bruzzone, francesco; scorrano, mariangela; nocera, silvio title: the combination of e-bike-sharing and demand-responsive transport systems in rural areas: a case study of velenje date: - - journal: nan doi: . /j.rtbm. . sha: doc_id: cord_uid: h l yy z an analysis of the operational characteristics of the transit system serving the town of velenje (slovenia) revealed poor performance and the need for improvements. this paper describes the potential integration of an electric bike-sharing system and a semi-flexible demand-responsive transport system to effectively solve this issue. additionally, general guidance is provided for transit systems with low travel demand. appropriate transport system schedules are proposed to facilitate customers' use and thus to move demand shares away from private motorized transport. focus group interviews, implemented to directly involve local stakeholders, revealed an overall positive perception of the proposed transport system. furthermore, the cost analysis demonstrated that the costs of the new system would not be much higher for the municipality than those currently incurred, making it an important performance improvement achieved at low cost. the considerable growth of mobility in urban centers over the last century has been accompanied by issues of sustainability. estimates show that while the world population has grown fourfold over the past century, passenger-kilometers in passenger transport and tons-kilometers in freight transport have increased by about times during the same period (ksenofontov & milyakin, ; mulrow & derrible, ) . although this massive travel development has had numerous positive effects, the intensity and extent of the negative local and global consequences on the environment are clearly evident, especially in terms of air and noise pollution, soil consumption, and land degradation (benintendi, merino gòmez, de mare, nesticò, & balsamo, ) . the current global strategy has thus become reducing the overall consequences while still keeping performance efficiency high. public transport is a key piece of the sustainable mobility puzzle. it can help move more people with lower energy consumption per passenger, provides a more affordable alternative for getting around, has a track record of fewer accidents, has significant potential for electrification, reduces congestion, improves air quality, and makes cities more livable and inclusive. outside of these benefits, however, public transport service is plagued with many challenges that reduce its attractiveness, including long waits at transfer points, insufficient coverage of more dispersed areas, insufficient integration with green modes such as cycling, and a sometimes negative perception or attitude towards public transport. this is especially true in suburban areas. these are larger than traditional cities and have significantly lower densities, implying greater travel distances for most trips, fewer origins and destinations within walking distance of any single route, and more kilometers travelled to reach activities. conventional public transport in such areas is often unable to meet accessibility needs and requirements of different user groups, resulting in large portions of the population relying on private motorized transport, high operational costs, and thus increased fares and low revenues. this leads to a vicious circle ( fig. ) of service cuts, further ridership fall, even lower revenues, and so on, to the point where services are discontinued (dirks, frank, & walther, ; organization for economic co-operation and development [oecd] & international transport forum [itf], ; velaga, nelson, wright, & farrington, ) . to tackle these challenges, transit planning must respond with appropriate services and policies to allow public transport to compete with private automobiles. there are two possible solutions. first, transit planning can utilize more flexible bus service, thus minimizing travel time by ensuring well-timed connections and providing these connections as effortlessly as possible with short walk distances, tight scheduling, and appropriate frequencies. demand-responsive transport (drt) is an effective method for instituting such a service. second, https://doi.org/ . /j.rtbm. . transit planning can offer better sustainable accessibility by connecting public transit with other transport modes, such as bicycles. despite the well-known potential of flexible transport systems (fts; mounce, wright, emele, zeng, & nelson, ) in increasing the use of transit and accessibility of rural areas, the operational, technical, and-especially-market feasibility of such systems remains an issue. studies have shown that operational sustainability of fts is not always granted; funding is often an open issue; and in a number of cases, a need for high subsidies has emerged (jokinen, sihvola, & mladenovic, ; oecd & itf, ) . other detected barriers to the appeal, implementation, and use of fts are poor understanding of mobility needs, the lack of integration with other modes, the difficulty in framing demand and user behavior, and the lack of communication between users and agency (brake, mulley, nelson, & wright, ; te morsche, puello, & geurs, ; velaga et al., ) . the last big issue to consider is related to the lack of viable options to cover the "last mile" between public transport stops and people's final destinations. to the best of our knowledge, no experiment has yet been carried out specifically on the integration between a demand responsive transport system (drts) and an electric bike-sharing system (e-bss), with the latter simultaneously acting as feeder and complement to the bus network. thus, this paper investigates the potential of the integration of a semi-flexible drts and an e-bss to effectively solve the problem of low transit travel demand. to achieve this aim, we analyzed the slovenian town of velenje as a case study. together with the municipality of velenje and through a consultation process with stakeholders and citizens, we developed a feasible and fundable drts proposal that integrates an extended version of the existing bss. we find that within the funding possibilities of the municipality and in full compliance with the objectives and targets of ongoing european union (eu)-funded programs, numerous progresses can be gained by benchmarking the proposal against the existing traditional bus system. this paper is structured as follows. section details the current kirchhoff ( ) . velenje's location. the integration of bike sharing (including e-bikes) and traditional transit systems has been studied previously and intensively. regarding the role of biking within modal integration, félix, cambra, and moura ( ) recently considered the effects of cycling infrastructure and the implementation of an e-bss in lisbon. they found that the combined effect of both interventions was a game changer for the city's cycling maturity. ma, zhang, li, wang, and zhao ( ) showed that demand patterns of commuters strongly impact the relationship between shared bikes and public transportation. their data showed that the transactions between shared bikes and buses had evident commuting characteristics during weekdays, while on weekends, travelers preferred to use shared bikes as a substitute for public transport. a similar result was achieved by sun, chen, and jiao ( ) , who considered how loyal members use a bss more for commuting while non-members use them more for recreation. fyhri and fearnley ( ) found that e-bikes, compared to traditional bikes, increased the number of trips and trip length for all age groups, regardless of trip reason (leisure or work), and are a practical and accepted solution for everyday travel. in a successive study, fyhri and beate sundfør ( ) found that e-bikes resulted in a greater shift away from cars compared to traditional bikes and argued that such mode shifts are long term rather than temporarily induced by good meteorological conditions or novelty. bronsvoort ( ) and bronsvoort, alonso-gonzález, van oort, molin, and hoogendoorn ( ) studied the possible upgrades for conventional pt services in rural settings, considering both the integration with a bss and the substitution with a drt, and found that time and cost are more important to users than reliability and flexibility. in a recent (footnote continued) study, sun et al. ( ) found that e-bikes prominently substituted car use for both commuting and shopping, and that those living in rural areas were among the most likely to forgo their cars in favor of e-bikes. guo and he ( ) studied the integration between bss and conventional public transport, concluding that areas with lower density of public transport stations have higher incidence of integrated use. from a drts planning perspective, studies agree that multimodality is a key driver for service sustainability and success (dirks et al., ; nelson & phonphitakchai, ) . features of the transit system in velenje. section describes the method that we propose to improve the service, including an economic analysis. section discusses the results obtained. finally, section concludes the paper. velenje is slovenia's sixth largest town and is located km (by road) northeast of the capital city ljubljana, km south of the austrian city of graz, and km northwest of zagreb (fig. ) . in , the slovenian municipality of velenje was home to , inhabitants (table ) distributed into local communities (sistat, ). its morphological and demographic characteristics make it a typical example of a dispersed area: it lies in a relatively wide lake basin surrounded by a hilly and rural landscape, throughout which are scattered settlements (fig. ) . to the west of the main urban core, the paka river valley leads towards central slovenia, hosting the railway towards ljubljana and a major road. also on the railway, the town of Šoštanj lies on the lakeshore opposite velenje. the modal split in velenje is unbalanced towards the use of private cars, despite a car ownership rate of cars/ inhabitants, which is less than the slovenian average of cars/ inhabitants (european environmental agency, ; halilović, ) . comparing data collected in the and municipality surveys, it is evident that the decrease in the modal share of private cars ( % vs %) has been fully compensated by an increase in the share of active modes (walking and cycling increased from % in to % in ). the role of public transport is therefore marginal (with a share of % and % respectively). the survey also investigated commuting distances, finding that a vast majority of respondents ( %) worked within km of their home (table ) , a distance that the slovenian ministry of transport considered to be cyclable in the guidelines for building pedestrian infrastructure (as cited in halilović, ) . these data demonstrate how the use of private cars exceeds expectations, which may be explained by the fact that public transport is currently not a daily commute option for those living outside the velenje city center, as schedules do not fit traditional office and business hours. to overcome the transport issues for those rural settlements lying in the northern, eastern, and southern sectors of the municipality of velenje, which are not served by rail or interurban buses, and to improve the modal share of public transport and active mobility, the city has established three suburban bus routes. the routes operate on weekdays only as part of a five-route local network (fig. ) , and they have an inaugurated bss. the bus service, which cost € , to run in , is currently free of charge for users (municipality of velenje, ). in , velenje's bus service transported , passengers, mostly aboard the yellow line in the city center (municipality of velenje, ). as shown in fig. , three suburban routes-the blue, green, and orange lines-are currently in operation. the yellow line provides frequent service within the urban core, and the red line is a "virtual" line comprised of a longer interurban route. at peak times (e.g., school hours), the orange, blue, and green lines do not run, and specific students-only services are operated (municipality of velenje, b). in total, up to four high-floor midi-buses are used for velenje's local services: three on the yellow route (two off-peak) and one alternately serving the blue, orange, and green lines (table ). the red line does not have dedicated vehicles because it is shared between several longer routes; however, the service is subsidized by the municipality of velenje within the contract for the local bus system and has thus been included in the analysis. table shows the route lengths and frequencies of the different lines. currently, the velenje bus system covers , km/year; thus, the value of the subsidy for public transport operations is . €/km. even if subsidized consistently by the municipality, the current public transport offer in velenje is underutilized. with the exception of the yellow line, it cannot be used to commute on a daily basis, as it does not operate during the morning rush hour and it offers a limited number of daily connections. its only, clear imprinting is that of facilitating weak categories such as the elderly and those impaired to drive in getting to the city center and making use of its functions, a common approach in slovenia's recent policy (gabrovec & bole, ). the yellow line, in contrast, provides relatively frequent service within central velenje. in short, velenje's public transit is characterized by a low frequency of service, lack of time coordination, low load factors, and a lack of ambition on the part of the municipality to fund it further. the only ways out of the vicious cycle in which deteriorating quality, tariff increases, and/or reduced routes lead to a lack of service are consistent resource investments from the authority in charge or a change in the service provision. this paper addresses these issues by proposing a different, integrated transportation concept for velenje and its suburbs that aims to increase the accessibility and ridership of its public transport, reducing the perceived distances between velenje and its nearby settlements while allowing the municipality to keep investments in public transport affordable. in this paper, a different strategy for velenje's mobility patterns that is based on a combination of a semi-flexible drts and an e-bss is discussed and evaluated through citizens' involvement (focus groups) and a preliminary cost analysis. the municipality of velenje has been successfully involved in eu-funded projects aimed at empowering cycling, walking, and public transport as a means to reduce externalities from the transport sector, enhance sustainability of commuting patterns, and increase accessibility throughout the region (recent and ongoing projects include chestnut, smile, and smart commuting). a discussion on possible options for changing the current underutilized public transport system began within the municipal offices and was later expanded as part of the smart commuting project. this paper is framed within that context and aims to design a financially sustainable transit network to best serve velenje's settlements. the combination of drts and e-bss has been identified as a promising solution through the analysis of the existing literature; this combination was refined thanks to a productive dialogue with the municipality of velenje and its citizens. relevant stakeholders and citizens were involved in this research through the eu-funded smart commuting project (which includes various engagement activities within the drafting of a sustainable urban mobility plan-sump-for the area) and through an interview campaign developed specifically as part of this research and carried out in the form of focus groups in march . a preliminary part of this work aimed at identifying daily mobility issues that people living in velenje face and exploring how citizens may perceive a change in the transit system. focus group interviews were hence implemented to examine citizens' willingness to use the new transport system and the trade-off between travel modes. the results have guided the service design and policymaking. transportation researchers often use focus groups to collect data (e.g., hwang, li, stough, lee, & turnbull, ; levin, ; naznin, currie, & logan, ; pudāne et al., ) . focus group interviews have several advantages over face-to-face interviews or questionnaires (hwang et al., ) . they allow for direct interaction with participants, which can help the researcher to get better insight into their needs and opinions than asking them to fill out a questionnaire. in fact, participants can exchange anecdotes, views, and experiences as well as express ideas that otherwise may have gone unheard. moreover, this qualitative method is a cost-effective way of collecting data because group interviews take less time than individual interviews. we made a cautious effort to select a balanced mix of individuals in terms of age, gender, professional status, ownership and/or availability of a car, and area of residence. participants were recruited among residents through snowball sampling, a nonprobability approach that is often used in qualitative research and in which the researcher recruits a few volunteers who, in turn, recruit other volunteers. people were recruited if they lived in velenje, spoke english, were years old or older, and had internet access. the authors acted as moderators for the focus groups. older people, who are usually retired and may need to use public transport the most, could be less confident speaking english or using the interview technology. thus, to prevent them from being overlooked in the focus groups, we invited their grandchildren/family members to help them. for those who did not have english-speaking friends or relatives, we made an interpreter available to ask questions in their native language of slovenian, allowing them to feel more comfortable. the participants were invited to the focus groups by e-mail or phone. we informed them about the focus group arrangements and asked for their consent to audio record the sessions and to use the collected data for scientific purpose. we guaranteed them that the data would be anonymized for confidentiality reasons. all participants agreed and gave permission for their quotes to be used in research publications. a total of people were recruited. we organized three focus groups of participants each. the sample size and group size choices were in line with the best practice literature (fern, ; guest, namey, & mckenna, ) . the groups had to be small enough for everyone to have the opportunity to share insights and yet large enough to provide diversity of perceptions, as suggested by krueger and casey ( ) . grouping people with similar characteristics increases the likelihood of shared experiences and fosters more comfortable conversation within each group (hesse-biber & leavy, ). we thus clustered the participants into three groups based on the area of residence (the suburban areas vs. the urban center of velenje) and, for residents in suburban areas, on age and professional status. since residents of less-served suburban areas might be more aware of the limits of the existing system and would more likely be the main potential users of the newly proposed public transport system, they were overrepresented with respect to people living in the city center. we further divided them into two groups since differences in the choice of transport mode may exist among younger working people and older retired ones. the interviews were conducted during the last two weeks of march via the skype and ms teams platforms. the covid- emergency prevented us from personally meeting the participants. however, as confirmed by the respondents, receiving a video call at home-an environment that is comfortable and familiar-decreased stress and made them feel more confident. moreover, it lowered time costs for the participants, allowing us to involve participants who would not have been willing to travel to reach the meeting place. fortunately, we did not encounter any technical issues, and everyone was able to easily connect to the platform. in alignment with the previous literature (krueger & casey, ; simons et al., ) , the interviews lasted approximately min in order to avoid exhausting the respondents. long meetings often lead to decreased attention spans. the timeframe allowed us to avoid this while still having enough time to develop the main topics. before each focus group, all participants were asked to complete a short questionnaire to collect data about their sociodemographic characteristics, including gender, age, education, annual income, work status, and the number of cars owned by the family in order to identify users who are more likely to choose the new transport system. table in appendix a summarizes this information. the overall sample was balanced between men and women. the majority of the respondents ( %) were between and years old, % were between and years old, and % were under . additionally, % had a full-time job, and % had a high school diploma. for half of the sample, the family owned only one car and had children. finally, % of the respondents stated that their annual family income was between € , and € , . we then used semi-structured guided questions for the interviews. a full list of guided questions can be found in appendix b. the interview began by asking participants their current daily travel mode and the main determinants of their choice (i.e., why they do or do not use the existing public transport system). thus, we encouraged them to put forward any problems with the current system and to suggest improvements. a scenario-type approach was then employed in which participants were presented with the hypothetical new transit system that we had developed together with the municipality based on public data about the existing system (e.g., routes, areas served, and number of buses) and from previous literature. the newly proposed system f. bruzzone, et al. research in transportation business & management xxx (xxxx) xxxx accounted for many of the issues that emerged in the first part of the focus groups. we showed participants the velenje map and explained our draft proposal for serving the area, which features a fixed schedule "backbone" line, a number of on-demand stops to be served upon reservation, and an e-bss that would be promoted alongside the drts (see fig. ). the use of the map enabled the participants to have a deeper understanding of the new system and to provide answers in a more systematic way. data analysis allowed us to identify four main themes: current mode choice, attitude towards buses, attitude towards cycling, and evaluation of the drts and e-bss. table summarizes the main results. the focus groups pointed out noteworthy differences between citizens living in the urban center (group ) and in the suburban areas (groups and ) of velenje. nearly % of the participants living in suburban areas owned at least two cars ( % for younger/working people vs. % for older/retired participants), whereas % of urban participants owned only one car. this difference is mainly explained by the poor accessibility and frequency of public transport in peripheral areas forcing respondents of these areas to choose a private car as their primary transportation mode. long distances, flexibility, and shorter travel times were the reasons suburban citizens primarily travelled by car. most of the respondents living in the urban area moved around the city center on foot or by personal bike. the short distance from their workplace to home was the main determinant of their choice. we observed differences between citizens in urban and peripheral areas in terms of their attitude towards using the bus. respondents living in suburban areas stated that they would like to use their cars less and switch to using the bus, but the limitations of the existing system prevented this. they stressed their need to walk more than km to reach the nearest bus station and complained about long waiting times at stations. they pointed out the low frequency of buses, the mismatch between bus schedules and working hours, and inefficient bus routes (to reach as many areas as possible, the routes are long and only go in one direction, thus lengthening the time it takes to reach the city center). one participant (a -year-old male) stated the following: there are only four buses a day, and they ride a not convenient route for me; they go in the opposite direction than what i need. they travel a longer route and take / min to get me to work. with my car i reach the workplace in only min. time matters. another woman ( years old) complained "my working hours do not match with those of the bus, therefore i am forced to take the car." a retired woman claimed "i would take the bus to go downtown, but there are very few routes, and the risk is to wait too long to go home." for the respondents living in urban areas, they forgo using the bus to move around the city center, preferring active mobility facilitated by the short distances. unlike the people living in more peripheral areas, they were quite satisfied with the existing public transport in terms of frequency, daily coverage, and costs (buses are free of charge for velenje residents). the long distances from the city center and the hilly landscape of the suburban areas meant that most people living in such areas did not utilize bicycles to reach the city center. other factors, such as travelling with a child or having a lot to carry, also decreased the likelihood of cycling. younger people, however, stated that they made use of bikes, but only for recreational purposes. replies such as, "i have a traditional bike, but i am not fit enough to cycle uphill for a round trip" or "i am too lazy to cycle" were common among older respondents. citizens in urban areas, on the other hand, proved more inclined to use bicycles because of the flat nature of the route and the shorter distances. most of them, however, stated that they would only use bikes if the weather was nice. we asked respondents if they felt that the proposed system could overcome the issues previously mentioned and if they would be willing f. bruzzone, et al. research in transportation business & management xxx (xxxx) xxxx to switch to this new system. we also investigated affordable tickets, expected booking time, reservation and payment methods, and whether they agreed that this type of service could improve the level of transport service, especially in less-served suburban areas. we used the collected information and suggestions to better define the design and policymaking of the drts. overall, we recorded a positive perception of the new transport service, which we feel is even more significant given the pandemic period in which the interviews were conducted. as for the drts system, there was enthusiasm, especially among participants living in the suburbs. they stated that if such a service guaranteed that there would be bus stops located closer to their homes and destinations as well as more frequent buses during working hours, they would consider the use of public transit as their primary daily travel mode. this implies that drts is a promising transit service in this area. the e-bss, in contrast, was deemed useful, but less so for daily trips: i would not ride a bike, even an e-bike, to get the city center or to reach the nearest bus stop. i often carry bags; i play sax, and i often carry it with me, so it would be inconvenient for me to ride a bike. it would be different to use this service on weekends. in that case, yes, i would gladly take the bike. ( -year-old female). the area where i live is not flat, then the distance from the center is relevant … using the bike at my age and in these conditions (up and down) is not the best! but the electric bike could be a great solution. i could consider it, but only to have fun during a sunny day. ( year-old female). great the possibility to rent the electric bike and not have to buy it. you take it only when you need it, and if you shop and have bags with you, you go back by bus. i think it's a good idea. it is also a way of doing some physical exercise. ( -year-old female). the discussion with participants also generated topics that the moderator had not anticipated, such as environmental aspects. some participants were particularly aware of environmental issues and wanted to contribute to environmental protection in some way, such as by leaving their car at home. thus, they were happy with the proposal and hoped it would be implemented. regarding the economic aspects, even though the existing public transport is free of charge, all of the respondents from the suburban areas claimed that they would be willing to pay for a ticket if the new service guaranteed more flexibility in terms of transit times and coverage. most of the respondents, in fact, seemed to be well-aware of the costs incurred from operating a car (fuel economy, parking fees, maintenance, etc.) and were therefore willing to consider the trade-off with the new system. people in urban areas were also willing to pay a ticket, but on average at a lower price with respect to those in suburban areas. many citizens suggested keeping the price low and considering the same fare for on-demand bus and e-bike sharing services. the reservation requirement was not negatively perceived by respondents as a barrier that would restrict flexible travel. younger respondents were enthusiastic about the app as a reservation tool but at the same time expressed doubts about the effective accessibility of such technology for older people or for people who are reluctant towards new technologies. for such users, they suggested also allowing phone reservations. we registered the same attitude among older respondents. as previously mentioned, on-demand services can provide transit to more users at lower costs by efficiently employing economic resources in terms of vehicles, staff, and fuel, thus improving services without a significant cost increase (rahimi, amirgholy, & gonzales, ) . depending on the characteristics of the areas to be served, the elements of flexibility can vary and may include scheduling, type of operations, type of vehicle, and area of operations (oecd & itf, ) . based on the features of the operations, four settings in particular were identified by nocera and tsakarestos ( ) : line operation (one to one), band operation (few to one), sector operation (many to one), and area operation (many to many; fig. ). a geographic information systembased analysis of current public transport operations and the distribution of households in the velenje area, together with some productive dialogue with the municipality of velenje, allowed us to identify the most relevant corridors and areas for public transport. these and other relevant settlements that are currently isolated will be included in the new drts and e-bss. a band type semi-flexible drts setting was selected among various possibilities as the most suitable for serving the area. this setting features a fixed schedule "backbone" line together with a limited number of on-demand stops served on reservation. a second sector-type drt line would also be introduced to serve selected areas and connect them to the train station. to enhance system accessibility, the improvement of the bss and an increased number of available e-bikes is promoted alongside the drts. fig. intuitively shows the functioning of a drt band-operation bus line, showing how the schedule may adjust for some intermediate stops to allow for efficient and reliable service in all situations, independently from the bus taking detours to serve on-demand stops or not. at selected intermediate stops, the schedule provides allowance for waiting in case the bus is requested to perform the longest route, thus allowing it to continue onwards within a given schedule allowance. this reduces the effectiveness of the service by lowering its commercial speed. however, it also cuts down on time fluctuations (which are generally not well-tolerated among customers), thus making up for some possible accumulated delay. as mentioned above, a semi-flexible drts was introduced for velenje. the draft discussed in the focus groups included two bus routes (to be operated by the existing fleet; see fig. ), an extended bss (compatible with the existing system; fig. ), and suggested a growth of the role played by buses and train stations as modal interchange hubs. during the early stages of the proposal development, a reduced bus coverage was considered, to be flanked by the additional provision of a collective taxi service to reach residents who live in rural communities and are unable to cycle. this option, however, was later scrapped due to excessive costs and low interest expressed by the municipality and key stakeholders, who stated their preference for a "proper" bus system. for these reasons, the proposed drts has been expanded to virtually any location reachable by bus within the municipality of velenje, thus providing a sensible increase in public transport offering. another reason of concern while defining the new transit system for velenje was the substitution of the yellow line with an on-demand service. it is interesting to stress that the change arising with the demand shifting from buses to other modes might not be fully absorbed by active transport (coutinho et al., ) . however, in this particular situation, this might not be the case for one should also consider that the yellow line provides a useful yet inefficient service for those unable or unwilling to walk or cycle within the urban core. as explained in section and as made evident by the focus groups' outcomes ("it is faster to walk [than to use the yellow line, ed]"), the yellow line mostly serves inelastic demand. moreover, velenje's city center is not an easily drivable area due to the many restrictions enforced. for these reasons, we believe that our proposed drt and e-bss could solve the issue presented by coutinho et al. for it aims at satisfying the inelastic demand that needs a pt service and it attracts new users currently relying on walking or driving to parking facilities and then walking the last mile. the architecture of the proposed drts for the velenje area is reported in fig. , which shows the new bus lines (in blue and red) and their relation to new and existing bike sharing and bike parking facilities (grey with green and black borders, respectively). fig. details the location of the bus stops and numbers them according to the schedule proposals reported in tables and . the "backbone" line , represented in blue, would run on weekdays every min from : to : . it would operate as a fixed-schedule line with a limited number of on-demand diversions (band operations) and would perform daily departures. diversions are designed to serve on-demand rural communities, often located uphill, thus easing access and regress to pt service while keeping costs and trip time low. the line would link the stadium (stop ), where a parking lot is located, with the train station and the gorenje factory (stop ), the main bus station (stop ), and some of the most inhabited suburbs of the city (laze, bevče, pirešica, vinska gora, and prelska). line , shown in red, would operate as an on-demand feeder to line along the red line. it would start at the train station (stop ) and offer a -min headway between : and : , with peak-time reinforcements. its scheduled departures, performed only if requested, would guarantee a quick interchange with line at the train or bus stations. the line links velenje city center with Škale (stops and ) and pesje (stops and ) before ending at the velenje-pesje train station. the details of the drts operations are reported in tables and . both lines would be operated according to a repetitive, easy-to-remember schedule. line is . km one way (excluding on-demand diversions) and takes min. including layovers, two vehicles would be (footnote continued) public transport. the balance between subsidy and fare revenue is at times also worse for collective taxi systems. the uk government statistical office ( ) declared a net subsidy per passenger trip of £ . in / , in line with values shown in the last decade, for rural pt services in england. a different government study (uk commission for integrated transport, ), instead, shows that collective taxi services in the uk and in mainland europe require a subsidy per passenger journey between £ and £ , rising over £ in smaller systems. needed to guarantee a -minute headway. line is comprised of three different subsections-one serving Škale ( km long), one serving pesje ( . km long), and a loop serving the velenje city center and bus station ( . km long)-all of which would be operated on demand only and would terminate at the train station. one vehicle could guarantee a minute headway on all sections, as shown in table . stops of both lines have been chosen in full accordance with the municipality of velenje, and existing stops (when present) have been maintained and reassigned to the new system. moreover, as mentioned already, a gis-based analysis has allowed to identify the distribution of households and population in the area. reservations would be made by phone or using a web application, with expected pickup times of a few minutes. the use of recent, realtime operations technological innovations would contribute to making fts a more inclusive, reliable, and attractive format compared to the current service (dimitrakopoulos, uden, & varlamis, ; mohamed, rye, & fonzone, ). current information communication technologies allow for real-time scheduling, which is managed by on-board a bss was recently developed in velenje as part of the european project known as chestnut (municipality of velenje, c). the system has since been expanded and now offers bikes distributed among stations in velenje (including three e-bikes; see fig. ) and bikes among five stations in the nearby town of Šoštanj (municipality of velenje, d). since both the implementation and maintenance phases have been fully funded by eu funds, the existing bss should not be included among current costs for public and shared mobility (bicy, ) . this paper proposes a reinforcement of the bss outside the city's main core for use as a feeder to both bus lines, with a specific focus on the modal interchange between both shared and private bikes and the fixed-operations buses of line . the integration of drt and bike sharing is, to the authors' knowledge, an innovative solution in rural contexts, and literature on the topic is not very extensive. however, benefits from "hardware" and "software" integration between multiple transport modes, which contribute to the mobility as a service concept, have been significant in a variety of studies as highlighted in ambrosino, nelson, boero, and pettinelli ( ) . the expansion of velenje's bss would include the provision of additional docking stations, six of which would be located at bus stops, and e-bikes. despite increasing investments and maintenance costs, the choice of ebikes as a complement to the existing bss is necessary due to the hilly geography of the area. the weather in velenje is known to be mild, with cold but dry winters compared to ljubljana and to the slovenian average (weatherbase, ) . the valley surrounding the city is sometimes advertised as the "valley of the sun". the literature has demonstrated that even with typical north-european weather, the use of e-bikes is consistent (fyhri & beate sundfør, ; sun, feng, kemperman, & spahn, ) ; the favorable climate in velenje has aided the success of the existing bss and encouraged future expansions, such as the one proposed in this paper. stations located in proximity to bus stops would be similar than existing ones, with eight to docks, a standard rotation of five e-bikes, and racks for safe storage of personal bikes, per european guidelines (obis-iee, ). stations located in rural settlements would be smaller, with an endowment of three e-bikes and five docks, in an effort to contain costs while enhancing the accessibility of the drts via bss or private bike. fig. shows existing (grey with black border) and new (grey with green border) bss locations. moreover, a digital tool will be made available for desktop and mobile use. the tool will manage all aspects related to service registration, bookings, payments, and information for both the bss and the drts. access to services will be granted by phone for users not acquainted with web technology. an additional or alternative measure to the development of the e-bss would be the provision of financial incentives to support private citizens in the purchase of their own (e)-bike. this measure was however not included in this paper as, unlike the expansion of the bss, it is not a structural solution and it is also not fundable through eu funds. the municipality of velenje acknowledged that the possibility of obtaining regional/national funds for this policy is scant under the current regional and national administrations, and that they had no political interest in such a solution. indeed, the outcomes of a plan of this sort are uncertain and, more importantly, it does not provide the city with bss infrastructure. the combination of semi-flexible drts and e-bss would increase the number of daily connections in velenje's settlements. in particular, residents of Škale and pesje would benefit from a maximum of daily rides compared to the current four and eight, respectively. residents of settlements located to the east of velenje, currently served by the green and orange lines, would benefit from a maximum of daily rides compared to the existing four. e-bikes and personal bike storage at bus stops would allow residents of rural communities to access the drts, thus increasing the potential user base. the integrated strategy as a whole is expected to generate a modal shift at the expense of private motorized transport (cass & faulconbridge, ) by expanding the number of potential users thanks to better coverage (both spatial and temporal, introducing peak time services and modal integration), thus allowing for a reduction in external costs generated by mobility in the area. the diverse elements of the proposed integrated strategy-the new, semi-flexible drt; the expansion of the bss with the provision of e-bikes and additional stations; and the development of a digital tool to manage the system-were subject to a cost analysis, which was compared with the current public transport and bike sharing offer. the cost analysis is reported in the following section. as discussed in the previous sections, the new transport system would prove particularly useful for satisfying velenje citizens' mobility needs. the project, however, must be economically feasible in order for the municipality to implement it. this section aims to verify whether the proposed transport system is economically advantageous compared to the existing one. for this purpose, we considered all the costs related to the implementation of a drts, an e-bss, and their integration. according to rahimi et al. ( ) , the costs for operating a bus public transport system typically include capital costs for vehicle purchases as well as variable operational costs related to fleet size (e.g., taxes, registration costs, and vehicle insurance), vehicle hours travelled (e.g., total wages, fringe costs, and overhead costs), and vehicle miles travelled (e.g., fuel, tires, and body repair). the total operating costs are usually shown in terms of operational hours and kilometers. the municipality of velenje awarded the public transport contract to a local contractor and currently pays an annual service contribution of € , , which covers an average annual distance equal to , km; thus, the service has an all-inclusive cost of . €/km, of which % goes to operating costs and % to drivers' wages (municipality of velenje, ). the proposed integrated system would optimize the overall routes by both lowering the minimum number of vehicles required to meet the demand without violating the time window constraint (thus decreasing the number of drivers) and by reducing the overall annual distance travelled. the latter varies between , km if no citizens reserve the on-demand bus service, and therefore the bus does not deviate from the main route, and , km if all of the on-demand stops must be served, thus considering both detour and line-haul travels. consequently, considering the current cost per km, the annual costs for operating the bus service range between € , and € , . a monte carlo algorithm allowed us to use the process of repeated random sampling to make numerical estimations of such parameter. we thus estimated an annual distance travelled of , km and an annual cost for operating the integrated system equal to € , . an e-bss is both a flexible addition/complement and an alternative to the public transport system. this system thus represents an opportunity for public transport operators to increase the attractiveness of their services because bikes can be used independently of timetables. the main costs to implement such a service from an operational point of view can be divided into two categories: infrastructure and start of the e-bikes have proven to be particularly useful when trip distances are important and when vulnerabilities-both in terms of the lay of the urban land (for example in the case of hilly streets) and individual physical conditions (for example, when considering people with health difficulties and physical impairments)-make traditional bicycles unsuitable. an e-bike reduces the effort required while saving travel time. thus, an e-bss can enhance connectivity for cities that are not bike friendly and have underdeveloped public transportation systems (ji, cherry, han, & jordan, ; langford, cherry, yoon, worley, & smith, service as well as operating costs. the costs of implementing large-scale systems (solar or grid-powered stations) would vary from € - per bicycle (obis-iee, ), depending on the system configuration. this range includes both the hardware (bicycles, stations, workshop, etc.) and software (system back end and customer interfaces). the operating costs would be between € - per bicycle per year, though this would vary according to the size of the system and the usage rates. the greater the bicycle usage, the greater the maintenance costs, customer support needs, and redistribution interventions. hence, the cost per bicycle would increase. overall, the total cost for implementing such a service is estimated at € , (purchase of e-bikes and stalls) and € , /year (maintenance). the integration between the drt and e-bss with the existing bss is an important aspect that should be taken into consideration. such an integration must take place on three levels: integration of information for facilitating intermodality, physical integration in order to integrate the bss with public transport during peak hours or in areas where public transport cannot satisfy all mobility requests, and integration of technological methods of access to services and tariffs. to this aim, we propose e-bike sharing stations located near bus stops and outside the city center for use in combination with public transport. regarding access and rates, taking into account the suggestions collected during the focus groups, we propose a fully integrated fare and ticketing system. such a change would allow citizens to use public transport and rent bikes/e-bikes for bike sharing with a single card or take advantage of special discounts, such as a single daily rate or a special discount for using bike sharing and other mobility services. these integrations would inevitably rely on mobile technology and thus require management software and an app. however, this would enhance public transport use and facilitate operational planning. among the most significant its applications for the modernization and rationalization of the public transport sector are the avl/avm systems for real-time tracking and localization of vehicles; user information systems for providing real-time waiting time at stops and/or on personal devices (smartphones/tablets); and multimodal and multicarrier platforms for mobile payments (based on microchip smartcards, contactless smartcards, short message service, mobile apps, nearfield communication, the internet, etc.). the overall costs of implementing such software would depend on its complexity. we estimate that it would cost € , , of which € , would be used to equip each bus with an avl/avm system for real-time tracking and localization of vehicles, and the other € , would go to the trip planning and the payment app (osservatorio nazionale sulle politiche del trasporto pubblico locale, ). the advantages derived from the application of its will be significant both for citizens (in terms of the regularity and reliability of the improved service) as well as for the services company and programmers. the mere extension of the avl/ avm system to the entire circulating fleet could lead to relevant savings in terms of the regularity of the vehicles, fuel savings, optimization of the use of vehicles, and driver shifts. as summarized in table , considering the overall costs of the individual systems and their integration, we estimate an initial investment equal to € , and an annual operating cost equal to € , (the latter only € , higher than the costs of the current system). although the new system requires an initial investment and annual operating costs that are overall higher than the annual contribution currently paid by the municipality, we believe that the public will find it attractive and economically advantageous for at least three reasons. firstly, the new system would allow for a reduction in social costs by promoting a modal shift from private transport to bicycles and/or public transport. this would contribute not only to lower urban air and noise pollution but also increase citizens' well-being through the use of table cost analysis. bruzzone, et al. research in transportation business & management xxx (xxxx) xxxx active transportation modes. the latter is both a direct effect given by new users of bike sharing and an indirect effect given by the greater diffusion of cycling that the presence of bike sharing typically induces. additionally, the presence of personal bike stands alongside those dedicated to bike sharing (which are monitored) reduces the risk of theft of individuals' personal bikes. in this sense, the bike sharing could contribute to bicycle marketing by giving it a positive and smart aspect and, more generally, to the development of an advanced and attractive image of the city that does not undervalue equity considerations. secondly, the integration of bike sharing with drts and the existing transport services (in terms of registration, payments, and unique smart cards for accessing services) would allow users to combine multiple modes of transport and thus contribute to making travel more convenient and efficient. for this reason, we expect an increase in the demand for such a system with respect to the existing one (equal to , passengers per month). however, even if the demand remained unchanged with respect to the current system, if the service required a fee (an integrated ticket) equal to € per ride, the municipality could obtain an annual revenue of € , , which would completely recover the initial investment in just one year. if the municipality instead chose to institute the new service free of charge (no registration and/or use fees), it could cover the annual imbalance with respect to the status quo by relying on advertising contracts, sponsorships (for the entire service or for individual components, stations, and/or bicycles), or revenue generated by parking charges or congestion charges. thirdly, the proposed system might help reducing the marginalization processes that typically characterize rural areas (daniels & mulley, ; vitale brovarone & cotella, ) . the low density and the peculiar geomorphological characteristics of such areas, generally combined with considerable distances from the city center where basic services and work and leisure opportunities are located, make these territories highly car-dependent. thus, the poor transit quality of velenje's surroundings definitely leads to reduced mobility of those who, due to age, economic, or cultural barriers, have no permanent access to a car. the proposed system, by providing a widespread and equitable mobility offer (not only to the elderly, but also to young people), might help not only to increase active mobility, alleviate congestion, and reduce environmental impacts, but also to counteract transport-related social exclusion. the resulting improved accessibility will thus contribute to a sustainable development of velenje. in this paper, we analyzed an unattractive and uncoordinated transit system in a slovenian town and proposed a new system organization based on the combination of a semi-flexible drt and an e-bss in order to solve an evident performance problem and promote the local population's use of public transport. this combined service would incorporate coordinated schedules for an easy-to-remember headway and to provide users with real-time information. the purpose is to minimize waiting times and operating costs while introducing a series of elements capable of increasing the perceived quality and thus shifting demand shares from private transport (chakrabarti, ) . in any pilot project that is based on the identification of the mobility needs of the populations concerned and on shortcomings in the current transport offer, the aim is to offer a system of transport services that can meet demand needs at an adequate level of service with minimal social cost for the community (liu & xu, ) . in such cases, the trial phase should be followed by regular assessments in order to correctly calibrate significant parameters. our results demonstrate that the proposed system would provide better quality service for the transit customers in velenje while using approximately the same amount of financial resources for its operation. compared to the existing bus system, the proposed combined drt and e-bss provides all-day service to a wider percentage of the local population, thus enhancing social inclusion and empowering those who are currently unable to reach the city center and train and bus stations autonomously. contextually, this system may also enable the local municipality to generate resources to cover the up-front costs through the introduction of low-price tickets and seasonal tickets. evidence from the focus group survey demonstrated a moderate consensus among the sample of possible customers, who expressed a substantial willingness to pay for a drt service that offers a high level of satisfaction. other results demonstrated the possibility of actually cutting down some external costs due to reductions in car use. some relevant gains were also apparent in the variation in the customers' average travel time: the performance of the integrated drts and e-bss would be supported by the application of an its solution for conveying information to customers. in interpreting these results, we have made some conservative assumptions to bolster our argument. first of all, the discussion of the results has not included any possible increase in travel demand, even though it seems legitimate to expect a customer gain due to the increased attractiveness of the transit supply. this, in turn, can generate positive effects related to (possible) consistently higher revenues, which could be the object of a specific assessment. the same holds true for the analysis of travel times: by its refinement, it could also be possible to see some positive time gains and consequent financial savings. another aspect to consider is the possibility to improve the level of customer satisfaction through specific actions, such as the creation of dedicated interchange facilities. in our proposal, we have tried to contain the expense figures and hence did not consider such a possibility in an earlier phase. however, because the proposed system is based on the train and bus stations, this lays the groundwork for further integrations in the future. furthermore, we did not consider the option of covering the initial infrastructural costs through revenues not already available to the municipality (e.g., those possibly deriving from the acquisition of a future eu-funded project, outstanding state loans, or contributions by foundations). however, the involvement of other key stakeholders could also bring advantages to the integrated system project. the methodology presented here is generalizable to other similar contexts, which is a significant advantage and a relevant benefit for policy purposes. future research could involve the use of optimization models to improve operational efficiency of the transport service (iliopoulou & kepaptsoglou, ; verma, kumari, tahlyan, & hosapujari, ; wei et al., ) or to tackle service and energy costs more specifically (batarce & galilea, ; brown, ; cavallaro, danielis, nocera, & rotaris, ; tong, hendrickson, biehler, jaramillo, & seki, ) . future work could also examine additional customer-oriented smart services because interconnected transit solutions foster the possibility of offering further specific services to organizations and transit users (nocera, fabio, & cavallaro, ) . finally, some heuristic meta-strategies could be used to improve the design of the bus routes (bräysy, dullaert, & nakari, ; suman & bolia, ) . sustainable mobility practices can be fostered through the promotion and diffusion of the right technologies as well as by offering combinations of transportation modes that are favorable to the population. ad-hoc measures aimed at increasing the availability and quality of public transport services can rebalance the preferred mode of transport in favor of sustainable transportation and reduce the number of vehicles on the road (lah, ) . the goal is to create a mobility system that strengthens the competitiveness of the territories through high quality services while also ensuring a more effective use of resources. among the key issues is the better integration of modal networks through increasingly connected systems and multimodal connection platforms for passengers. successful, environmentally friendly solutions include smart mobility (lyons, ) , carpooling and carsharing (bulteau, feuillet, & dantan, ) , enhancement of local transport (mctigue, rye, & monios, ) , integrated planning of transport modes (holz-rau & scheiner, ), apps and systems for infomobility (catalano & migliore, ) , the construction of new cycle paths (mayakuntla & verma, ) , toll and pricing policies (cavallaro, giaretta, & nocera, ) , and electric mobility (lemme, arruda, & bahiense, ) . in this context, any pilot projects that foster integrated planning into this process would have particular value. in this paper, we described the integration of an e-bss and a drts to solve the issue of low demand for public transport in the slovenian town of velenje. in general terms, placing a pilot action in real contexts means involving local stakeholders and policymakers from the very first stages of planning. additionally, the plan must consider how differences in infrastructure, geography, orography, settlement and urban planning, and travel demand (including non-systematic mobility) may influence the definition of the key aspects of the system. in the case of system combinations, a main transport system along the primary routes must coexist with one or more adduction systems supporting it (le pira, ignaccolo, inturri, pluchino, & rapisarda, ) . our results show that with funding levels comparable to the existing conventional bus system, a combination of drts and e-bss could be set up to offer broader service hours to a greater share of municipal citizens. unlike most literature on the topic, in this paper, we developed and evaluated a preliminary cost analysis of this fundable system and concluded that even if there was no increase in users and no application of fares, the municipality of velenje would be able to finance the proposed system with its own resources or by participation in eu-funded sustainable mobility projects. the proposed integrated mobility system presented here would not optimally solve transport issues in velenje's suburban areas; however, it would increase the number of settlements with daily and frequent access to the train and bus stations and to public functions downtown, thus allowing citizens to access public transit and sharing services independently and to choose them for their daily commute. thus, the proposed system would allow for more equitable distribution of opportunities and accessibility throughout the municipality, making a small step towards transport universality. people and authorities of the st century tend to take for granted freedom of movement. however, awareness is growing regarding the environmental and social costs of travelling as well as the need for fair, inclusive, and accessible transport systems. some concerns about individual responsibilities for containing primary pollution are also emerging at both the local level (zhou & lin, ) and on a global scale as more people are now conscious of and concerned by climate change (nocera, ruiz-alarcón quintero, & cavallaro, ; nocera & tonin, ; nocera, tonin, & cavallaro, ) . to some extent, the ongoing coronavirus disease (covid- ) crisis has shown that individual behavior can be substantially modified and travel substituted through technological innovations. in many cases, however, there is still no substitute for direct contact, which requires physical displacement and the subsequent creation of certain social costs. however, these costs can be contained through the provision of efficient and lowimpact transport systems. the provision of such services must be a central consideration in order to guarantee sustainable future development. however, considering the complexity of modal split mechanisms, striving for an efficient and low impact service may not be sufficient to reduce the negative effects of the mobility system as a whole. this research has been developed under the common responsibility of all authors. (continued on next page) − welcome and thank the participants. − introduce yourself and provide a brief description of the research. − review the ground rules: everyone's ideas are important, and everyone will be given an opportunity to speak. there are no right or wrong answers; even negative comments are useful in gaining insight about the topic under discussion. − remind everyone that the session will be recorded. − remind everyone that the whole process is confidential: anonymity will be kept; all the audio recordings and transcriptions will be used solely for research purposes. − provide the researchers' contact details. − ask if there are any initial questions before the focus group starts. − ask everybody to introduce themselves: discuss the existing public transport in velenje ( min): − which mode of transport do you use most often to go to the city center? which are the main determinants of your choice? − why do you (or do not) use public transport? • let people share their thoughts and experiences. − do you have a bike? do you usually ride a bike to go to the city center? why? • let people share their thoughts and experiences. introduce a scenario-type approach in which the focus group participants are presented the drts + e-bss ( min): − explain that this is our draft scheme based on previous contacts with the municipality and on the literature. • are you interested in this service? why or why not? • would you be willing to pay a ticket for this new service? if so, how much would you be willing to pay? • is -min notice enough time to book the bus service? • booking and payment would be done via app. would this be acceptable? − thank all the focus group participants for their time and effort. − remind them that the use of all information collected will be confidential. − ask the participants whether they would like to receive a follow up (to be generally informed about the conclusions of the study). enabling intermodal urban transport through complementary services: from flexible mobility services to the shared use mobility agency: workshop . developing inter-modal transport systems cost and fare estimation for the bus transit system of santiago energy, environment and sustainable development of the belt and road initiative: the chinese scenario and western contributions available online at key lessons learned from recent experience with flexible transport services the potential of optimization in communal routing problems: case studies from finland exploring alternative public transport in rural areas preferences towards bus alternatives in rural areas of the netherlands: a stated f. bruzzone, et al. research in transportation business & management xxx (xxxx) xxxx choice experiment fair fares? how flat and variable fares affect transit equity in los angeles carpooling and carsharing for commuting in the paris region: a comprehensive exploration of the individual and contextual correlates of their uses commuting practices: new insights into modal shift from theories of social practice a stackelberg-game approach to support the design of logistic terminals should bevs be subsidized or taxed? a european perspective based on the economic value of co emissions the potential of road pricing schemes to reduce carbon emissions how can public transit get people out of their cars? an analysis of transit mode choice for commute trips in los angeles impacts of replacing a fixed public transport line by a demand responsive transport system: case study of a rural area in amsterdam flexible transport services: overcoming barriers to implementation in low-density urban areas. urban policy and research intelligent transport systems and smart mobility. the future of intelligent transport systems designing intermodal transportation systems in rural areas available online at a survey on planning semiflexible transit systems: methodological issues and a unifying framework build it and give 'em bikes, and they will come: the effects of cycling infrastructure and bike-sharing system in lisbon. case studies on transport policy the use of focus groups for idea generation: the effects of group size, acquaintanceship, and moderator on response quantity and quality do people who buy e-bikes cycle more? effects of e-bikes on bicycle use and mode share adapting transport related innovations to rural needs: smart mobility and the example of the heinsberg region how many focus groups are enough? building an evidence base for nonprobability sample sizes built environment effects on the integration of dockless bikesharing and the metro master's thesisuniverza v ljubljani, filozofska fakulteta, oddelek za geografijo the practice of qualitative research land-use and transport planning -a field of complex cause-impact relationships. thoughts on transport growth, greenhouse gas emissions and the built environment a focus group study on the potential of autonomous vehicles as a viable transportation option: perspectives from people with disabilities and public transit agencies integrated transit route network design and infrastructure planning for on-line electric vehicles electric bike sharing: simulation of user demand and system availability policy lessons from the flexible transport service pilot kutsuplus in the helsinki capital region public transit research and development in germany focus groups: a practical guide for applied research the automobilization process and its determining factors in the past, present, and future sustainable urban mobility in action. sustainable urban, mobility pathways north america's first e-bikeshare: a year of experience modelling stakeholder participation in transport planning optimization model to assess electric vehicles as an alternative for fleet composition in station-based car sharing systems how may public transport influence the practice of everyday life among younger and older people and how may their practices influence public transport? feeder transit services: choosing between fixed and demand responsive policy integrated multilevel measures for the transformation to a transit metropolis: the successful and unsuccessful practices in beijing getting smart about urban mobility -aligning the paradigms of smart and sustainable impacts of free-floating bikesharing system on public transit ridership a novel methodology for construction of driving cycles for indian cities identifying barriers to implementation of local transport policy -lessons learned from case studies on bus policy implementation in great britain operational and policy implications of ridesourcing services: a case of uber in london a tool to aid redesign of flexible transport services to increase efficiency in rural transport service provision is slower more sustainable? the role of speed in achieving environmental goals sustainable transport in velenje podatki poslovanje v , . . . municipality of velenje. chestnut project web page bicy bike sharing web page key challenges in tram/streetcar driving from the tram driver's perspective-a qualitative study an evaluation of the user characteristics of an open access drt service the adoption of grid transit networks in nonmetropolitan contexts assessing carbon emissions from road transport through traffic flow estimators a joint probability density function for reducing the uncertainty of marginal social cost of carbon evaluation in transport planning carbon estimation and urban mobility plans: opportunities in a context of austerity demand responsive transport systems for rural areas in germany optimizing bike sharing in european cities: a handbook international experiences on public transport provision in rural areas how will automated vehicles shape users' daily activities? insights from focus groups with commuters in the netherlands demi-flexible operating policies to promote the performance of public transit in low-demand areas system modeling of demand responsive transportation services: evaluating cost efficiency of service and coordinated taxi usage why do young adults choose different transport modes? a focus group study selected data on municipalities improvement in direct bus services through route planning research in transportation business & management xxx (xxxx) xxxx promoting public bike-sharing: a lesson from the unsuccessful pronto system modal shift implications of e-bike use in the netherlands: moving towards sustainability? potential uptake of adaptive transport services: an exploration of service attributes and attitudes life cycle ownership cost and environmental externality of alternative fuel options for transit buses a new approach to rural public transport the potential role of flexible transport services in enhancing rural public transport provision development of hub and spoke model for improving operational efficiency of bus transit network of bangalore city improving rural accessibility: a multilayer approach rainy days in ljubljana and velenje evaluating public transit services for operational efficiency and access equity spatial-temporal heterogeneity of air pollution: the relationship between built environment and on-road pm . at micro scale research in transportation business & management xxx (xxxx) xxxx key: cord- -hvujl d authors: gavrila gavrila, sorin; de lucas ancillo, antonio title: spanish smes’ digitalization enablers: e-receipt applications to the offline retail market date: - - journal: technol forecast soc change doi: . /j.techfore. . sha: doc_id: cord_uid: hvujl d the brick-and-mortar retail smes (small and medium enterprises) market is confronted with unprecedented challenges: digitization procurement in a company not prepared for a digitalized business model, and the actual digitalization process of the business model, which not only changes the business rules but disrupts them with new possibilities. despite industry . transforming manufacturing in terms of the way of producing and distributing goods by means of process digitization, the offline retail smes market is struggling to satisfy customers’ shopping expectations due to two direct constraints: existing offline competitors operating under a narrowing market share, and online retail competitors increasing market share due to their better positioned ecommerce it platforms. the purpose of this work is to study the potential effect of digitalization on smes, focusing on businesses operating in the offline retail market, by means of provisioning cloud solutions supporting the business digitization process. the study is based on data collected from a wide range of official sources in conjunction with extensive research work reviewing technologies applicable to these kinds of businesses. the validation is performed through the focus group methodology between the months of june to october , with participants from the henares corridor, madrid (spain) area, considering them as a relevant sample of offline retail smes in spain. the value proposition of this study can help offline retail smes understand the difference between digitization and digitalization, the necessity of digitalization in their businesses, the existence of accelerators such as e-receipt cloud solutions, and the disruptive potential of digitalization to their business models on long-term survival regarding competitors and raising the circular economy. the brick-and-mortar retail smes (small and medium enterprises) market is confronted with unprecedented challenges (minco-tur, ): digitization procurement in a company not prepared for a digitalized business model, and the actual digitalization process of the business model, which not only changes the business rules but disrupts them with new possibilities (fitzgerald et al., ; gartner a) ; all within the background of a deep crisis triggered by online ecommerce competitors, which forces offline retail smes to digitalize or die due to the continuously changing market (safari et al., ) . however, recently an additional issue has gained popularity: the covid- pandemic which has taken all society, business and industry by surprise and will most probably lead to a major domestic and global economic recession (carlsson-szlezak et al., ; wren-lewis, ) ; unfortunately with the current available data it is still too soon to assess its entire economic impact. the investigation of the literature and secondary sources has been focused on the most tangible elements affecting the day-to-day aspects of smes regarding digitization (pricewaterhousecoopers, ) and the ability to create new added value for customers (chung et al., ecommerce online competitors and their technological barriers that stop them becoming digitalized, has been done, where the study explores the context of the industry . pressure on companies (minc-otur, ) , as well as analyzing the concepts applicable regarding digitization and digital transformation of offline retail smes within the ever-changing market trends and demands (gartner a) , linking the market requirements to the growing challenges of multi-channel customer communication, such as sms (mccorke et al., ; guberti, ) , e-mail (hartemo, ; reimers et al., ) , instant messaging mobile applications (amirkhanpour et al., ) and social networks (brown, ) . at the same time, the research examines some of the reasons why social networks have increased in popularity (guberti, ) , as well as the reasons why they have transformed the business-customer interaction relationship (camarero izquierdo, gutiérrez cillán and san martín gutiérrez, ) , where customers have increased the demand to know exactly what is being delivered to them from the source of the raw materials up to the manufacturing process (oh and teo, ) . this demand is also taking on customization, where companies are expected to adapt to new market trends and ways of utilizing the product (palmer and ponsonby, ; charlesworth, ) , such as the shared economy or the collaborative economy, where clients are not only expecting but demanding a particular solution, while also requiring personalization in shape, color, or timing, which shifts the entire way companies deliver and do business challenging them from the manufacturing process to the intermediaries and shipping agents (haas et al., ) . retail smes are transforming into small value-added aggregators that are expected to respond to customer needs, all under the umbrella of unstoppable pressure for environmental protection and efforts to reduce waste management within daily operations (haanpää, ) . given the aforementioned scenario, the research inevitably addresses the comparison with regards online retail smes, which from a technological point of view are far better positioned as they can acquire more in-depth knowledge regarding their customers based on the way the ecommerce platform is developed (safari et al., ) . in contrast with offline retail smes, they obtain selling patterns and conversion paths (san-martín and jiménez, ) allowing them to take quick decisions based on real time data (devaraj et al., ) . on the other hand, offline retail smes lack that body of information and rely only on basic sales information from erp (enterprise resource planning), whereas the use of crm (customer relationship management) is missing (faedpyme, ) and the technological barriers prevent them from digitalizing (mincotur, ) . the methodology section describes how the study has been developed in a multi-step process relying on the initial identification of the sme gaps contrasting extensive literature research from derived studied and official data sources, summarizing the outcomes regarding the applications to smes. based on the identified gaps, an e-receipt conceptual model has been postulated regarding technological aspects that an e-receipt platform should envision as a digital enabler for the transformation of offline retail smes, trying to anticipate the possible issues and converging solutions, such as technological barriers (faed-pyme, ; ontsi, ) or delivery of the actual digital receipt functionality (berson et al., ; safari et al., ) . the hypothesis of the e-receipt as digital enabler has been contrasted on the basis of an empirical research of a focus group methodology, between the months of june to october , involving the participation of offline sme retailers from the henares corridor, madrid (spain) area, segregated into a first set of participants following an evaluation questionnaire answered based on their hands-on business experience regarding the relevance of the e-receipt within the participating retail companies and about how the envisioned e-receipt solution could fit into their daily operations; together with a second set of nine participants while writing the article in order to fine-tune the first set focus group outcomes. extensive research was carried out in order to draw the e-receipt conceptual model guidelines used during the focus group activity, from the point of the components and the subsequent interactions between the companies which implement it and their customers. each module describes the necessary steps required for a successful iteration and the impact that could have on the smes if implemented (mijanur rahman and ripon, ) . the modules describe in great detail the customer perspective within the e-receipt ecosystem, as well as what tangible value is created and distributed among all involved actors. the implementation outlines the offline sme-related aspects from the point of view of the technological barriers, the tight integration of the e-receipt within business activity, the multi-channel distribution as well as all the new interactions generated with the client in a simple format easily exploitable and deployable (fundación telefónica and red.es, ; ontsi, ) . this involves customers within the daily business activity and obtains information regarding their preferences so that smes can create new sorts of products or services that satisfy both the requirements and personalization level demanded by them (devaraj et al., ) . the platform explores new forms of customer interaction through a multi-channel, dynamic advertising system based on shopping patterns. finally, it investigates how companies can gain new sources of information and knowledge about their customers throughout the analytical dashboard (faedpyme, ; ontsi, ) providing cross-selling and up-selling patterns so that they can create new engaging campaigns that meet customer interest and demands (chung et al., ) . the results section focuses on the outcomes of applying the e-receipt platform as a digitalization enabler to offline retail smes and how this could help them to accelerate towards digital transformation of their business model and new business opportunities -as far as the digital transformation of the paper receipt is concerned -reducing the technological barriers (ontsi, ) especially with regard the integration of software-as-a-service cloud services, the multi-channel communication with their clients, the possible analytics and insights provided by the e-receipt platform to assure customer satisfaction and loyalty (fundación telefónica and red.es, ; ontsi, ) . the other outstanding items addressed in this research are the environmental aspects demanded by both customers and companies to fight the generated waste due to business activity (mineco and corrales, ) , but also the issues most underestimated by companies, such as cybersecurity (incibe b) that are becoming more relevant and impacting on society every day, as well as the regulations related to privacy that allow customers to take control and action regarding their personal data (incibe, ) . finally, the conclusions section synthesizes the offline retail sme market demand for digital enablers and the hypothesis of e-receipt as an accelerator could lead to a tangible impact on both businesses and society in terms of possible solutions to technological barriers and the requirements of multi-channel customer interactions, together with their corresponding practical and theoretical implications. as the research field focuses on only particular aspects, as described under the limitations section, the investigation offers many possible lines of future work, such as the internationalization of the research to other markets, their possible technological implications or further discussion regarding customers' behavior and patterns. what is known: offline retail smes struggle as the lack of digitalization creates a technological gap in data collection and analytics (fae-dpyme, ; ontsi, ) , leading to decisions based on intuition due to lack of supporting data, slow reaction time based on observed occurring trends, reactive business actions, under-utilized or non-existent customer behavior information or lack of customer behavior analysis tools (minc-otur, ). therefore, in order for offline retail smes to remain competitive, they have to make the appropriate investment in technology (mincotur, ), but this is not an easy task for all smes, as it implies procurement, training, hardware and software compatibility, maintenance or dedicated it staff (safari et al., ) . these aspects also affect the personalization and customization of the offered products and services, where customers are left only to the provided number of choices without the possibility of making additional changes. customers expect and demand a product or service that fits their needs and not the needs of the retailer or the manufacturer (oh and teo, ) , where shared economy and circular economy require the retailers to customize their products to the new consumer habits (haas et al., ) . therefore, the authors have established extensive bibliographic research covering both international and national references, organized in five main areas (table ) considered as high potential impact on offline retail smes that could explain the contextual smes situation table theoretical framework model and main contributions. own elaboration. source main contribution . industry . context, digitization and digitalization (arnold et al., ) research industry . digital enablers transform companies' business model and internal organization, together with the relationship between partners and customers, under a cost-efficient paradigm. (fitzgerald et al., ) research digital transformation success is strongly linked with the technological dissemination, organizational aspects and leadership qualities. (davenport and prusak, ; porter and heppelmann, ) research the transition from data to information and knowledge sets the baseline for the digital transformation; and information as a key asset that feeds the internal it systems to support business operations and continuity. (delgado et al., ; autio et al., ) research entrepreneurship and start-up success is connected to its technological foundation and its capacity to transform data into knowledge. (mccorke et al., ; guberti, ) research factors such as technological availability, ease of interaction, openness to advertisement, personalization and incentives aspects, have evolved the sms from a personal communication function to a key marketing tool. (hartemo, ; reimers et al., ) research equivalent to sms, permission-based e-mail marketing provides potential for greater customer involvement and engagement, while empowering their decisions (opt-in / opt-out). (church and de oliveira, ; modak and mambo, ) research mobile chatting applications provide companies with a cost effective (compared to sms) and more interactive (compared to e-mail) alternative channel. (al-suwaidi, ) research social networks have changed customer behavior and privacy concerns favoring a more connected and exposed personal life in terms of opinions, brands or product preferences. (dholakia et al., ) research social network community groups can bias customers' shopping preferences due to the group belonging and bonding feeling, as well as to social behavior pattern of "influencers and followers". (palmer and ponsonby, ) research "prosumers" (users that consume and generate their own social content) show a positive outcome regarding the effects of the social network to indirectly promote and advertise brands or products. (oh and teo, ) research hybrid online and offline selling channel approaches demonstrate positive effect on the overall personalized customer experience (integrated product and price information), as well as an increase in the perceived service quality. (haas et al., ) research the circular economy is considered an actionable way for companies (generating new business models and opportunities) and consumers (more conscious behavior and personalization) to reduce the waste generated and pollution. (chung et al., ) research social networks' pattern-based recommendation algorithms may provide customers with a more accurate product personalization than the actual self-customization approach. (safari et al., ) research companies relying on software-as-a-service or cloud-based solutions provide substantial opportunities for the business operations, such as cost reduction, agile decision making and scalability. (devaraj et al., ) research customers choose to buy from the online or offline channel based on platform familiarity, cost and service quality criteria. (kim et al., ) research the crm software success is linked to a customer-oriented model fed by continuous data sources, such as offline sales data, online sales data, online customer interactions, inventories and existing products. (berson et al., ) book general erp and crm software provides smes with cross-correlation of sales and customer data functionality to obtain information regarding smes' customer habits. (haanpää, ) research there is a global consumer pressure on smes for a circular economy and a greener business activity footprint. (herbig and milewicz, ; karaosmanoglu and melewar, ) research in addition to regulations, companies must adapt to the consumers' demands as they require to publicly express a waste reduction commitment through corporate social responsibility (csr) and actual facts. references specific to spanish environment (mincotur, ) website governments can have a strong positive impact on the local business ecosystem by providing companies with access to industry . information, technologies and financial credit facilities. (mincotur, ) report spanish government report pointing out that online commerce has been cannibalizing offline market share and that future investment in business digitization is essential. (ontsi, , ontsi, report spanish government report pointing to the barriers of smes towards digitalization and the related business issues derived from the lack of appropriate icts. (faedpyme, ) report report on spanish smes' digitalization achievement, corporate social responsibility (csr) and environmental management, as well as the investment situation in icts. (san-martín and jiménez, ) research the m-commerce-based strategy is found to provide spanish smes with a direct selling channel where the customer obtains a personalized value proposition, under a cost-efficient paradigm. (cid, ; casas, ) articles more restrictive regulations against mass texting and associated costs push spanish companies to explore new channels, such as mobile marketing or social networks. (incibe, (incibe, , b report spanish government report regarding smes' cybersecurity threats, vulnerabilities and investments in icts. (incibe, a) report spanish government report regarding smes' and customers' privacy adherence to gdpr regulation. from the point of view of digitalization, communication, customer habits, technological barriers and environmental constraints, which later on will act as a baseline for the e-receipt model validation. the novelty of this research is to validate the feasibility of the e-receipt conceptual model as an actual digitalization enabler along with its suitability aspects within the offline retail sme environment. retail smes. the industry . transformation provides more customer personalization options, as well as a streamlined production process, either for service or product, which all companies, regardless of whether they are a manufacturer or an intermediate (arnold et al., ) , can take advantage of to generate and create new business opportunities (fitzgerald et al., ) . the industry . model is of great interest as governments and international institutions pursue its implementation (mincotur, ) in society, both customers and businesses, by providing financial stimulus for smes to digitalize and improve their business models to be more competitive on national and international markets (autio et al., ) . digitization as digital procurement: according to gartner (gartner b) , the digitization process can be considered as the internal process companies execute in order to purchase equipment, either new or refurbished, with digital capabilities such as sensors, connectivity or advanced information processing, which replaces existing obsolete or near end-of-lifecycle equipment. as the purchase of equipment is considered as a major investment, the companies are usually motivated to buy new hardware in two situations: ( ) maintenance costs of existing equipment are higher than the cost of new equipment; or ( ) to support the company strategy, such as creation of new products or increase of business capacity (porter and heppelmann, ) . despite the equipment upgrade, the digitization process does not necessarily imply a change of the business model (pricewaterhousecoopers, ) , it only increases the company's automation capacity and control over production. operations, interactions and activities involving customers or providers remain unaltered. digitalization as business model transformation: on the other hand, following gartner (gartner a) , the digitalization process can be considered as the internal process that companies execute in order to transform their existing business model into a digitally-based business model where the ict (information and communications technology) is located at the core of the daily operations involving customers and providers into the business activity (pricewaterhousecoopers, ). the basis of the company's digitalization process is the actual digitization plan to acquire the necessary icts: on-premises equipment or equivalent cloud services subscriptions. without it, the digital transformation process cannot take place as the company lacks the necessary data inputs, processing capacity and data exchange mechanisms. as the digitalization process involves customers and providers, the company can take advantage of new business opportunities that were not previously explored due to their lack of feasibility (porter and heppelmann, ) : ( ) interact with the customer, by means of social networks, websites, trends or direct communication channels to obtain data that can be further transformed into information (davenport and prusak, ) regarding habits and personalization preferences (chung et al., ) ; ( ) apply this information to products or services to personalize or to create new ones that adapt to the customers' needs and formats (safari et al., ) , such as cloud paas (product-as-a-service) or saas (software-as-a-service) based; and ( ) integrate with providers (delgado et al., ) to automate orders of goods, such as the drop-shipping model, or different shipping options, such as bikeriders or future drone-based methods. sms for business: sms remains an underexploited solution for business activities (mccorke et al., ; guberti, ) , especially due to the price (cid, ) and local regulations (casas, ) . offline retail smes: ( ) normally do not send any confirmation messages, such as shipping delivery notices, pick-up confirmations; or ( ) use them to interact with the customers, such as chat bots already being employed by other sectors; or ( ) for marketing actions, such as periodic delivery of promotional brochures or coupon codes. unfortunately, sometimes sms is also used for unsolicited communication (spam) (casas, ) or illicit scams targeted to obtain an economic benefit. e-mail for commercial actions: with the extensive use of the internet, e-mail has become one of the most exploited business communication channels (hartemo, ; reimers et al., ) , and smes do at least one business activity by e-mail: invoices, quotations, support and helpdesk activities, advertisement, club membership, government paperwork, etc., at virtually no cost as compared to the sms or paperbased alternatives. as this is one of the most used communication channels around the world, it also becomes a target of unsolicited mass spam messages that the account owner never signed up to receive (karwal, ) , or even criminal actions such as targeted scams to obtain an economic benefit. e-mail service providers and government regulations try to fight and protect consumers from these kinds of actions. instant messaging mobile applications for business: instant messaging (im) applications can be considered as one of the most popular mobile applications categories and have completely surpassed sms in terms of exchanged messages figures (church and de oliveira, ) . some smes have adopted the im mobile channel with relative success (amirkhanpour et al., ) , but with some limitations as the actual applications are designed for personal communication rather than business purposes. nowadays, im applications try to replicate the same personal communication success story, but in a b c (business to consumer) communication context (modak and mambo, ) , where the business owners can interact with their customers in an easy and convenient way by making use of existing im applications (jubin, ; katre, ) . these new ims' features for business are expected to include business information, business hours schedules, automated chat bots that reply to customers' requests or crm (customer relationship management) integration. social networks for business: the power of social networks has changed social habits (brown, ) . social networks connect millions of users together, which opens new marketing opportunities for any kind of business activity, including the social network itself, a major part of whose income comes from advertisement services (charlesworth, ) . the first social networks were merely closed groups of friends that shared specific content and were very concerned about privacy; as opposed to the new generation, the so-called digital natives, who have overcome the fear of privacy (al-suwaidi, ) and not only publish, but expose their personal life in the role of "influencers" of other users. this shift of habits affects marketing campaigns, as today's social network users demand experiences, want to know more about products or services and their added value (guberti, ) , care about the environment and demand a personalized service; whereas most smes do not even own a social network account (ontsi, ). however, customers also criticize errors and mistakes (charlesworth, ) , therefore, companies are forced to keep up with reputation indexes and develop comprehensive marketing strategies (camarero izquierdo, gutiérrez cillán and san martín gutiérrez, ) leading to new business models and new job titles, such as community manager. large companies have noticed that corporate website use has fallen in favor of social networks, therefore in order to preserve contact with their customers, some have developed chat bots that automatically reply to users' enquiries by means of direct messages chats. demanding experiences: the retail consumer's buying patterns have shifted from simple economic transactions to experiential transactions (dholakia et al., ) . the latest generations, from millennials onwards, changed their consumption habits, preferring to rent or pay per use; and they demand information regarding the production and origins of the raw materials. as social networks have a tremendous impact, companies now create special online customer experiences to enhance the brand or product awareness (aaker, ) , where top influencers evangelize how the customer experience should be, promoting the experience of shopping for that brand or the use of the product, instead of the traditional "buy this product" advertisements (palmer and ponsonby, ; charlesworth, ) . social network channels promote a differentiation strategy by creating a story behind the product or brand, making them unique (evans, ) ; and positive feedback, such as like or love buttons, as well as posting comments or retweets, increasing the customer interaction and impact of the product or brand (kerpen, ) . ecommerce websites provide automated product recommendations following customers preferences, using a clean and straightforward user interface with outstanding "buy" and "check-out" buttons, as well as a rating score, such as stars or similar shape, based on previous published customers' feedback (amirkhanpour et al., ) , delivering a very lean customer experience where the buying process is simplified and, together with virtual money wallets, reduces the stress of paying: customers obtain the product they were looking for and achieve the satisfaction of a good investment based on the positive reviews in a hassle-free transaction process. personalization and customization: customers expect and demand a product or service that fits their needs and not the retailer's or the manufacturer's needs (oh and teo, ) , where shared economy and circular economy require retailers to customize their products to the new consumer habits (haas et al., ) . many offline retailers complain and criticize how their customers stopped buying specific goods and tend to rent or to share them as a service: the tendency is that the shared-economy model is changing the whole society, including businesses. customers are not only expecting a personalized product or service according to their needs, but also customized in shape, color, format or delivery options (chung et al., ) ; companies must adapt themselves to the new business models of shared economy and circular economy, otherwise they will struggle to meet the market's needs and expectations (charlesworth, ) . despite industry . (mincotur, ) transforming goods production and distribution by means of process digitization (arnold et al., ) , the offline retail sme market is struggling to satisfy customers' shopping expectations due to two direct constraints: existing offline competitors operating under a narrowing market share; and online retail competitors increasing market share due to their better positioned ecommerce it platforms (safari et al., ) . technologically, all offline-based smes acknowledge the fact that online commerce has been cannibalizing offline market share and that future investments in business digitization are essential (mincotur, ). table depicts the position of non-it platform-based offline retailers as compared to it platform-based online retailers. it platform-based online retail businesses, as opposed to non-it platform-based offline retail businesses, where business decisions are usually based on intuition due to lack of supporting data, have a deeper understanding of their customers regarding demand forecasting and shopping experience customization (san-martín and jiménez, ), as they continuously collect behavioral information across the whole shopping process (turban et al., ): ( ) shopping patterns and conversion paths; ( ) cross-sale information and trending sale information; ( ) customer segmentation, micro-segmentation, conversion and retention rate; ( ) customer targeted promotions based on historical transactions; and ( ) cross-channel performance measured by inbound traffic on social networks. average offline sme retailers, with the exception of medium to large enterprises that allocate specific budget for business digitization to achieve digitalization (faedpyme, ; ontsi, ) , lack the appropriate instruments to collect customer behavior data or to elaborate adequate insights (ontsi, ): ( ) existing software mainly focusing on accounting and erp (enterprise resource planning) aspects; ( ) under-utilized or non-existent crm (customer relationship management) software; ( ) non-existent customer or sales analytics tools as they are perceived as high complexity and time-consuming tasks to be done the business owners; ( ) new software is normally not in the scope of the annual budget and bears an investment risk with an associated roi (return on investment) assumption; ( ) new software is perceived as time consuming as it requires support, training and optionally new hardware installation; and ( ) new software is perceived as providing too many features not required for the daily business activities or not completely fitting the business model. in general, offline sme retailers focus on sales figures and reports (faedpyme, ), but they do not correlate that data into a crm system, thus they cannot extract information regarding customer habits (berson et al., ) . one of the most valuable types of data a retailer possesses is sales data, as it provides traceability to each and every transaction executed in the business activity. but this data is not relevant in itself unless it is correlated with customers. some businesses implement this correlation by means of member club cards, where a customer provides the member card in order to get a benefit such as a discount or personalized promotion. the strategy behind this is to correlate the invoices to a specific member who previously provided some personal information in order to join the club; this way the company can compile statistics and extract patterns from invoices, and provide personalization based on consumers' habits and preferences. due to the nature of the ecommerce, where everything is digital, all transactions are conveniently stored in the erp database ready for crm analytics (devaraj et al., ) . in addition to the sales data, different aspects of user website behavior can be added, such as: ( ) reference to how the user arrived on the webpage; ( ) historically what products user has been looking for; ( ) interest, in the number of times the product was displayed; ( ) urgency, as the time duration buying the product. combining all this information, ecommerce can then adjust the ps marketing theory: product reviews, placement and recommended products, price adjustments and promotion on the landing page. on the other hand, for an offline retailer this normally stays only at transactional level, without exploitation of the crm information (kim et al., ) , with the retail manager in charge of the ps: product review and quality check, placement on the shop floor, price adjustments based on intuition and promotion based on traditional advertising formats; relying on personal experience and empirical experiments. based on these facts, there seems to be an important gap between online and offline retail segments, where offline faces multiple difficulties in identifying and attending to customers' needs. there is global demand from consumers for a circular economy and waste management (haanpää, ) , as well as a number of regulations aiming to reduce the footprint of business activity on the environment (mincotur, ) . from the point of view of the environment, the society as a whole is increasing awareness regarding the human activities generating waste and how these actions negatively impact on nature (aaker, ) . business activities, by means of srb/scr (social responsibility of business/ social corporate responsibility) commitment (herbig and milewicz, ; faedpyme, ) regarding green initiatives and reducing waste as part of the daily activity, are expected to be as environmentally friendly as possible, at the same time lowering their environmental footprint (karaosmanoglu and melewar, ) . cybersecurity is one of the major concerns worldwide and stands as one of the most important topics within companies' digitization and digital transformation, as illicit hacking actions are expected to become more and more frequent (incibe b; ontsi, ) . on the other hand, privacy is another top priority item as spanish lopd (organic law on data protection) and international gdpr (general data protection regulation) regulations are constantly evolving (incibe a) while customers are becoming more conscious of their digital fingerprint, where failing to comply with the standards on data collection and data processing could lead to substantial fines for smes. the study is based on data collected from a wide range of official sources in conjunction with extensive international and spanish research specifically identifying and describing the sme offline retail market status in terms of multiple aspects, such as digitalization, communication channels, customer habits, technological barriers and environment, selected by the authors as fundamental to understand and place companies in their exact technological position with regards to the market status and their competitors from both offline retail and online retail-based companies, as well examining the applicable technologies for this sme segment. based on the identified literature and market gaps, a conceptual model regarding e-receipts as digital enablers covering its technological components, user interaction flow and analytics within the offline retail sme transformation context has been elaborated to be further validated within focus group activity, consisting of approximately min (excluding wrap-up and clean-up steps) of semi-structured, faceto-face interview sessions with different offline retail sme management-related key personnel who agreed to participate in the research. the henares corridor, madrid (spain) area has been considered as highly relevant for this study as it overlaps offline and online retail smes as well as major e-commerce logistic centers, such as amazon. initially, a total of local offline retail smes were contacted by e-mail during the months of june and july , asking whether they were willing to participate anonymously in an economics research project involving a face-to-face, short discussion session (table ) after or before the close of business hours with someone who had a role related to management functions. from the total number of contacted companies, only replied to schedule a date for the interview, while an additional nine delayed replies were received between september and october . therefore, the hypothesis of the e-receipt as a digital enabler has been contrasted on the basis of an empirical research study of a focus group methodology involving the participation of a total of offline sme retailers who were presented with the e-receipt conceptual model, segregated into a first set of participants following a semi-structured evaluation questionnaire answered based on their hands-on business experience regarding the relevance of the e-receipt within the participating retail companies and about how the envisioned e-receipt solution could fit into their daily operations; together with a second set of nine participants while writing the article in order to fine-tune the first set of focus group outcomes. retail companies could provide invoices using both paper support and digital support in order to accommodate each customer's preferences. by providing an electronic receipt or e-receipt, the companies could associate the invoice with a customer and could analyze that information (berson et al., ) in an anonymous way or in a personalized way, if the customers have previously provided their consent and personal information. the e-receipt solution (fig. ) could be developed by third-party cloud-based technology companies and provided to companies following a saas (software-as-a-service) model (safari et al., ) , on a monthly subscription plan to mitigate the financial impact on the business activity. the next section describes one fig. . e-receipt technological components example. own elaboration. gavrila and a. de lucas ancillo technological forecasting & social change ( ) of the many possible e-receipt models, following a holistic analysis regarding the most relevant modules, expected functionalities and conceptual user interface. nevertheless, the authors must state that the hypothesis of the e-receipt has been formulated independently of any possible resemblance of existing patents or existing solutions. the e-receipt could be implemented as a third-party service on a cloud platform (fig. - . ) , where retailers could integrate their pos (point-of-sale) software (mijanur rahman and ripon, ) by means of a dedicated desktop connector installed on the company's premises. this simple connector would act as an interface between the sales software database and the e-receipt database. each time a transaction is done, the connector would synchronize the database information and would generate a new digital receipt entry. every time a transaction is done, the cashier would ask the customer the preferred receipt format: paper-based or e-receipt. if the customer wants a digital receipt, the cashier would ask for the preferred communication channel and input that information, such as e-mail address, social network profile, via the connector's virtual keyboard or phone number using the numeric keypad, and finally would press the send button. any information is optional as the customer can easily provide it within the url access link. the e-receipt desktop connector would synchronize ( fig. - . ) with the e-receipt cloud platform exchanging the sales information and associating the transaction with the provided customer identification data. after the information is uploaded on the cloud platform, it would be automatically processed, and the digital receipt would be sent to the customer phone through the appropriate communication channel. the e-receipt platform ( fig. - . ) would not only be a cloud-based solution that would avoid the ownership of on-premises hardware, software licenses or associated costs of support and maintenance, but would also be deployed as a saas (software-as-a-service) distribution model where the e-receipt solution would be provided as a pay-per-use application service where companies would only pay for a monthly subscription fee including all associated hardware, software licenses, support and maintenance costs and would only need to subscribe the capacities required for their operations, eliminating any technological entry-barriers. from the financial point of view, the saas model would avoid companies making any kind of up-front investment in elements not considered part of the business core; and from the accounting point of view, companies would consider the monthly fee as part of the daily activity. the e-receipt cloud platform ( fig. - . ) would be in charge of: ( ) permanently storing all the received transactions and crosschecking them with the customer identifier; ( ) distribution of the e-receipt information according to the communication channel provided; ( ) providing a permanent url database for e-receipt retrieval together with the e-receipt information upon retrieval request; ( ) advertisement display management together with digital data treatment management (opt-out and opt-in of customers in compliance with privacy regulations); and ( ) analytics services. upon receiving a transaction from the company's pos e-receipt plug-in connector, the e-receipt cloud platform would automatically distribute it (fig. - . ) virtually on any kind of communication channel as preferred by the customer. from the technical point of view, the e-receipt could be implemented on any communication platform, potentiating the customer's communication relationship and multichannel presence such as sms, e-mail, social networks or even im mobile applications. companies could hold multiple communication strategies such as providing an sms-only option as a fallback for older people or for non-social network users, and an e-mail or social network channel for other interested customers. the customers would receive a notification message via their preferred communication channel containing brief information regarding the company, such as name and store location, sending the notification as well as an online short url (uniform resource locator) unique access code to retrieve the e-receipt. the customer could retrieve ( fig. - . ) the e-receipt at any time by opening the provided url unique access code that would open a web browser to access the e-receipt responsive front-end ui regardless of the accessing device, such as computer, tablet or mobile. customer could share the url with any other person or third-party applications, such as house accounting or digital notebooks for their own record. the e-receipt responsive front-end ui elements could take into consideration the following minimum items (fig. ): ( . ) advertisement banner, that could be based on the advertisement display system as part of the e-receipt platform analytics feature; ( . ) legal information area, mandatory as per paper-based receipt related regulations; ( . ) transactions information area, mandatory as it describes the transaction status; ( . ) barcode area, mandatory for barcode scanner; ( . ) qr code area, which could be used for sharing the e-receipt; ( . ) social network area, which could be used for sharing or storing the e-receipt within social networks accounts; and ( . ) an unsubscribe url, that could be used for adjusting the privacy configuration, such as how data is collected and processed, within the e-receipt platform. finally, the e-receipt platform would provide analytics ( fig. - . ) to the retailers regarding their customers' activity, where the e-receipt dashboard could be considered as its core and would provide meaningful information regarding the most important aspects of the sales activities: ( ) sales analytics insights: the sales dashboard could contain the daily, weekly and monthly sales reports to be compared for performance and to support the business decisions; and the products performance dashboard could provide insights of top selling products as well as top margin leading products; ( ) advanced analytics module insights: the cross-sales dashboard could provide the most relevant product pairing that could fit other customers based on sales data; automatic reports could contain customized reports that could be triggered upon specific conditions, such as "lower than x amount sales" figures, and could be sent automatically to the specified e-mail addresses; periodic reports could contain customized reports that could be scheduled or sent periodically, such as "weekly average sales on x product category", to the specified e-mail addresses; and the multistores benchmark could be a specific feature for businesses that operate more than one store and might want to compare sales performances between them; and ( ) customers performance insights: the visit counter could display how many times a customer is visiting the store and historical transactions record; the loyalty index could be an automated index rate based on the historical transaction record, including return rate of products and digital tickets number of visits; and targeted campaigns could propose advertisement actions based on the sales analytics data to engage the customers in a personalized shopping experience. by reviewing the extensive available international and domestic literature, by designing the e-receipt conceptual model and by validating it using a focus group methodology, as described under their corresponding sections, the potential of e-receipt as a digitalization enabler has been positively concluded, together with a relevant number of outcomes (table ) regarding the applicability dimension of e-receipt within offline retail smes. local regulations require offline retail smes to provide a printed receipt to their customers upon the execution of any kind of commercial transaction; without any added value to customers or the company itself. on the other hand, thanks to companies' digitization (gartner b) , such as the procurement of new software or cloud subscriptions, companies can take advantage of these digital enablers and take the opportunity to pivot the paper-based receipt towards a digital accelerator in the form of an electronic receipt or e-receipt. this approximation can be considered as an example of business digitalization (gartner a) or "digital transformation", as the receipt is not only being digitized from paper format, but its final use and purpose is repositioned to generate new value propositions and business opportunities (faedpyme, ) in the offline retail market: where customers benefit from a digital e-receipt copy for permanent storage while reducing paper waste; and companies enhance customer fidelity based on sale analytics data never before exploited in the offline retail channel. smes' digitalization process is generating new market needs (fae-dpyme, ), where software providers take advantage of the potential gaps and develop cloud services based on the subscription model, such as saas (software-as-a-service) (safari et al., ) , allowing them to reach more companies than before, as due to the cloudbased architecture the platform is scalable in performance, accessible online from any place, and the subscription-based costs are no longer an entry barrier. consequently, smes are adapting to these market changes (fig. ) : companies have stopped buying complete in-house software solutions and consider contracting them as an external service based on a monthly rate while reducing expenses and lowering the investment risk (ontsi, ) . therefore, the existing smes technological barriers disappear in favor of new business opportunities (ontsi, ): ( ) upgrading to new features or web-based functionalities erp (seethamraju, ) ; ( ) integration of simple and efficient sales analytics tools within the web erp plug-ins database; ( ) deployment of simple and efficient webbased crm software (berson et al., ) ; ( ) simple to calculate software ownership costs together with a clear monthly fee accounted for as a cost part of the daily activities rather than an investment; ( ) reduced investment risk: if the software does not fit the purpose it can be simply canceled without any penalties or depreciation of the hardware or software, as the whole platform is external and located on the cloud platform; ( ) saas reduces the required support needs as all the technical maintenance is done by the provider, while the company can focus on the training and how to get the most out of the product; ( ) saas products provide subscription plans based on the requirements of each company so it can select the plan that fits best; and ( ) providing the latest version and updates of the platform, therefore reducing the risk and need of buying additional software or periodic upgrades, that not only cost money, but can also break feature compatibility with older versions or other companies' software. as the e-receipt provides a deeper understanding of the customers based on the collected analytics, habits and preferences, companies can interact following the most adequate communication channel or mix of channels, as best considered (fundación telefónica and red.es, ; ontsi, ) : ( ) sms channel: in addition to the integration with the e-receipt for url distribution, can be used for basic information such as confirmation messages, delivery notice, pick-up confirmation, interact with the customers by means of chat, or for marketing actions such as periodic delivery of promotional brochures or coupon codes with unique reference number for further analytics purposes. nevertheless, the cost of the sms will always limit the scope of action; ( ) email channel: to be exploited as a cost-effective alternative to sms for e-receipt platform in combination with e-mail marketing campaigns regarding promotions and new products, as well as to act as a bridge towards social networks interaction; ( ) instant messaging for business: companies can replicate the e-receipt interactions from sms and e-mail channels virtually at almost no cost, while including business information, business hours schedules, automated chat bots that reply to customer requests, and crm integration; and ( ) social networks: can provide a private e-receipt interaction by means of direct messages features, or create shopping experiences as the customers want to know more about the product or services, their added value, their impact on the environment and what kind of personalization is provided. the e-receipt platform helps companies grow their business by transforming the traditional retail approach into a digitalized hybrid solution (faedpyme, ; ontsi, ) based on sales information not fully exploited before: ( ) improved market response: by knowing the sales trend, the customer can anticipate to the next super-sale product or to the next sale-season demands; ( ) improved customer reaction time: insights providing deep information regarding the customer lifecycle, empowering companies to take marketing actions that pursue everchanging customer preferences; ( ) improved proactive actions: on the floor store operations, such as pricing and promotion, can be done based on real store metrics just when they occur; ( ) improved data collection: providing additional sources of information, such as number of accesses to the platform, customer interest index, returning customers, return product rate, among others, that provide companies with new perspective regarding the customer segmentation; ( ) template- fig. . conceptual software-as-a-service lifecycle cycle in smes. own elaboration. based scenarios: intuitive and easy to use platforms facilitate companies in the creation of their own reports and access to meaningful insights without the need of expensive training or third-party applications; and ( ) faster results and communication: the customers can target marketing campaigns in real time and establish direct communication faster than any other paper-based, radio or television channel. despite social network campaigns targeting the most demanded products or services, they should not be limited only to those, as the crm and e-receipt can provide cross-sales information (berson et al., ) , the companies can focus on the rest of the sales drivers, differentiating themselves from their competitors and engaging with their customers in a more personal approach providing not just a product (chung et al., ) , but a complete solution, such as a complete outfit for a target occasion. based on the information collected, they can adapt the tone and messages expected by their customers (devaraj et al., ) , and can segment based on the specific url reference used to access the publication, according to the origin of the actions, such as sms, social network or im. as an underlying conclusion, smes must improve their social network strategy as today there is a major gap between business activity and the customers (ontsi, ). when customers turn to the offline retail channel, they expect and demand a similar process, however there are different human aspects not taken into consideration that can negatively affect the customer experience: ( ) the retailer might not have enough time, motivation or knowledge to assess the customer's questions. the customer is required to search online for the technical questions or comparison, and probably will end the transaction online on a competitor's website rather than in an offline store; ( ) prejudice regarding the retailer, such as physical look or behavior, may encourage or discourage the transaction, as opposed to ecommerce where there is no human contact. the retailer may try to bias the customer, such as promoting a specific brand and may potentially hide information, such as available stock or quality issues. the retailer may lose the transaction if the customer discovers the shopping process is being manipulated. customers are not only expecting a personalized product or service according to their needs, but also customized in shape, color, format or delivery options, and companies need to integrate the customer analytics information from a crm and e-receipt platform in their business models, or they could struggle to satisfy the market needs (minco-tur, ). this process involves all the supply chain: ( ) the producers need to be able to satisfy the market demand in terms of quality, price and characteristics; ( ) shipping companies need to accelerate the delivery of the products; ( ) intermediaries or aggregators need to add special values or disappear from the process; ( ) retailers need to reduce stock and offer more personalization options, and diversify their providers or producers so they can create new and unique products according to their customers' needs. finally, they must collect and analyze the customers' trends to anticipate and provide a personalized catalog of products or services. the paper-based commercial advertisement is based on generic promotions to call customers' attention and pursue them to finalize an economical transaction. however, those promotions target many segments and they are required to run for a large amount of time, such as on a monthly or weekly basis. the e-receipt advertisement feature is highly appreciated by offline retail smes as it provides an additional mechanism to reach customers and engage them in the shopping process (fundación telefónica and red.es, ) . companies can make use of the self-service e-receipt platform to create their advertisement campaigns based on their own designs or on existing templates without the need of external help. the e-receipt platform by cross-referencing the sales patterns and customers' information has the potential to transform advertisements and discounts into a personalized shopping experience (camarero izquierdo, gutiérrez cillán and san martín gutiérrez, ) , while establishing a continuous communication channel with the digital subscriber customers (chung et al., ) where they receive promotions based on their real interests, which compared with the paper-based version would require a lot of resources, such as printing and distribution, and generate a lot of paper waste. those promotions could be accessed in real time by means of the multiple available channels such as sms, e-mail, im or social networks, and they could have a limited duration based on the retailer's needs. the deployment of an e-receipt solution is found to create a positive impact on the society by reducing the environmentally-generated paper waste in an actionable way (anderson and cunningham, ) . offline retail smes perceive it as a tangible and economical approach to reducing their waste footprint, especially when they are receiving a lot of pressure from the srb/scr (social responsibility of business/ social corporate responsibility) intentions that are more and more demanded by the society (faedpyme, ): ( ) reduce paper waste: by means of using a digital copy, the paper version is not needed anymore. the impact can be then measured in economic terms such as cost of the paper rolls or in number of saved trees; ( ) go green initiative: as the whole society is targeting being greener (mineco and corrales, ), both companies and customers can participate in this aim by choosing a digital copy instead of the paper versions. companies, despite their good will and good intentions of going green, need to evaluate the real cost involving this action (minco-tur, ), and here the e-receipt solution based on cloud and softwareas-a-service leverages the risks, which instead of requiring a big investment works seamlessly with the current platform at a very low monthly rate; and ( ) stop losing tickets: from the customer point of view, a big advantage over the paper-based version is that the digital receipt does not deteriorate and is always available in a convenient format. consequently, customers only have to access the permanent url to access the full information and cross-check the transaction details. on the other hand, the business only needs the unique receipt reference to get access to the transaction elements for any modification. from customers' it security perspective, they seem more likely to use dedicated cloud-based e-receipt services rather than on-premises solutions that may not protect their privacy and data. similarly, companies are found to be keener on storing e-receipts on a cloud solution rather than storing them on site (incibe b) . this is due to the fact the cloud solutions are perceived as more secure as the cloud datacenters have dedicated cybersecurity teams, more advanced than any other solution a retail sme could deploy; but also due to technical reasons such as maintenance, uptime or backups that are normally performed by cloud datacenters experts, more skilled and reliable than sme office-level it employees. the e-receipt solution is found to help improve customers' privacy, as they would be empowered to decide what commercial actions, such as analytics, advertisements, and third-party information sharing, are subject to the data they generate, by means of automated and confidential opt-in and opt-out selection built within the platform (incibe, ) . without technological automation, these processes would take very large amount of time and resources affecting both business activity and customers' privacy. as highlighted from the researched literature, offline retail smes are urged to position themselves and embrace the digitization and digital transformation of their processes in order to pivot their business model towards a customer-centric approach involving suppliers, providers, manufacturers, shipping companies, multi-channel communication, product or service customization and personalization; all within the context of the ever-growing circular and sharing economy. smes are forced to adapt to the everchanging market rules and trends in order to remain competitive, not only on the spanish market but also at the european and international level, where the offline retailers are expected to transform themselves into value-added aggregators to differentiate themselves from the better prepared online ecommerce platforms as well as other offline retailers, as opposed to being mere intermediaries. fortunately, the digital barriers due to the technological platforms' complexity are now leveraged due to the third-party software providers developing software-as-a-service cloud solutions, which bring smes affordable and customized solutions without the software and hardware maintenance inconveniences. more than ever, smes need these digital enablers to help them accelerate their business transformation: ( ) to integrate with third-party partners participating in the delivery of the products or services; ( ) to collect data during the whole transaction process; ( ) to collect data regarding customers on all multi-channel dimensions; ( ) to analyze and process that data to extract information regarding the next advertisement steps together with personalization and customization strategies; and ( ) to comply with cybersecurity, customer privacy and environmental concerns. in an effort to assist and accelerate that digital transformation, the research has constructed a hypothetical e-receipt technological scenario, describing the platform components regarding possible cloud-based synchronization, multi-channel delivery, optimized user interface, advanced advertisement and analytics functionalities, among other aspects, which address the identified smes' shortcomings, such as industry . deployment, customers' ever-changing habits, technological barriers, narrowing market due to ecommerce and other offline competitors, as well as strong environmental pressure; and providing an achievable and easy-to-adopt digital enabler within the business activity while delivering tangible value for both customers and companies. practical implications: the research, the process of which has focused on offline retailers and has evaluated comprehensive literature material together with an extensive source of secondary information, envisioning an e-receipt conceptual model for offline retail smes while empirically contrasting and fine-tuning the outcomes within with a focus group of spanish offline retailers, as described within the methodology section, points to the fact that the provision of certain cloud solutions associated with e-receipts, such as gdpr compliant electronic receipts sent to personal e-mail addresses or by sms to mobile phones, offered as a value-added service enabler to their customers, could facilitate spanish offline retail smes in both digitization and digitalization processes: • customers benefit from e-receipt for permanent storage while reducing paper waste to the environment; • smes benefit from a tangible srb/scr (social responsibility of business/ social corporate responsibility) commitment regarding go green initiatives and reducing paper waste as part of the business activity; • smes benefit from a proper instrument that collects shopping behavior data not exploited before and analyses that data to get internal insights aimed to personalize customers' shopping experience. training remains mandatory to properly operate the platform; • smes benefit from an automated cloud platform with no on-premises hardware, based on a periodic subscription model without any initial upfront investment needs; • smes' business model pivots from a generic and static approach to a hybrid online-offline and personalized customer experience approach; • smes' business model pivots from a product-centric to a solutioncentric model, driven by collected customer behavior information and product lifecycle information; and • smes' business model, as part of the customer product customization, can easily expand and integrate circular economy business model principles, such as collaborative sharing, product-as-a-service options, refurbishing or taking care of the end of the product lifecycle, to expand income sources as well as to cover unattended market segments. theoretical implications: however, the underlying objective of the e-receipt hypothesis as a digital enabler is to provide smes, independently from their market segment, with a comprehensive understanding regarding the challenges associated with the digital transformation process by starting from conceptualizing a mere theoretical model up to the actual integration of it as part of day-to-day business activities, supporting and extending the theoretical baseline of the research. • digitization: this can be considered as the procurement process by which companies purchase new equipment that converts analogic parts of the company's processes into digital (gartner b) . despite the equipment upgrade, the digitization process does not necessarily imply a change of the business model; it only increases the company's capacity of production automation and control over it. the company operations, interactions and activities with customers or providers remain unaltered; • digitalization: this is considered as the internal process that companies execute in order to transform their existing business model into a digital-based business model where the ict (information and communications technology) is located at the core of the daily operations involving customers and providers to the business activity (gartner a); • the necessity of digitalization in their businesses: as opposed to ecommerce, the offline retail smes market is struggling to satisfy customers' shopping expectations due to two direct constraints: the existing offline competitors operating under a narrowing market share, and the online retail competitors increasing market share due to their better positioned ecommerce it platforms (ontsi, ) . technologically, all offline-based smes acknowledge the fact that online commerce has been cannibalizing offline market share and that future investments in business digitization are essential (fae-dpyme, ); • multi-channel communication for customer experience and customization: based on the information collected companies can adapt the tone and messages expected by their customers (hartemo, ; reimers et al., ) . the e-receipt platform could provide multiple url reference numbers according to the origin of the actions, such as sms, social network or im (amirkhanpour et al., ); • the existence of accelerators such as e-receipts cloud solutions: this not only provides a digitized version, but its final use and purpose is repositioned to generate new value propositions and business opportunities in the offline retail market, where customers benefit from a digital e-receipt copy for permanent storage while reducing paper waste; and companies enhance the customer fidelity based on sale analytics data never before exploited in the offline retail channel; • saas delivery as a solution to technological barriers: software providers take advantage of the potential gaps and develop cloud services based on a subscription model, such as saas (safari et al., ) , allowing them to reach more companies than before, as due to cloud-based architecture the platform is scalable in performance, accessible online from anywhere and the subscription-based costs are no longer an entry barrier; • the disruptive potential of digitalization to their business models on long-term survival regarding competitors and raising the circular economy: undoubtedly the e-receipt has a disruptive potential of enabling smes' digital transformation by involving customers in the business activity while generating new value propositions and business opportunities in the offline retail market, where customers are not only expecting a personalized product or service according to their needs, but also customized in shape, color, format or delivery options (haanpää, ; mincotur, ) by strengthening this relationship, companies can differentiate themselves from their competitors and engage with their customers in a more personal approach by taking advantage of the multi-channel communication, providing not just a product, but a holistic solution involving the principles of the shared and circular economy, based on collected information regarding their new shopping behavior (ontsi, ); and • environmental involvement to create a positive impact on the society: by reducing the environmental generated paper waste in an actionable way, companies perceive e-receipt as a tangible and economical approach to reduce their waste footprint (herbig and milewicz, ; faedpyme, ) . as in any investigation, there aresome limitations of this study. despite the positive outcomes regarding the e-receipt as a digital enabler application to smes, the authors have identified some specific areas that should be taken into consideration regarding the interpretation of the results and future works related to this study. ( ) market limitations: one limitation is the actual analyzed market segments, where the study was focused specifically on offline retail, leaving room for further analysis regarding additional segments where e-receipt could also be considered as fit for purpose; ( ) geographical limitations: as the study was conducted in the spanish environment, there is an option that not all outcomes could be extrapolated to other international markets, hence the requirement of further investigation regarding the applicability of e-receipt to more widely international smes; ( ) methodology limitation: as the focus group methodology could provide biased outcomes due to the discussion context and qualitative aspects, as compared to a survey-based approach which could provide quantitative comparable results; and ( ) some theoretical framework-related limitations: despite multiple software patents available in the market, there is a lack of specialized literature regarding e-receipt applications and how smes could practically adopt these improvements, consequently limiting the overall applicability of the identified study outcomes. although the scope of the paper is limited to the above-mentioned conclusions, the following section outlines several possible lines of action to guide future investigations regarding this subject matter: ( ) international market research: inevitably, research should be expanded to benchmark against other european or other international markets and how they might behave against similar technological circumstances. one possible example would be united states smes, which are showing a considerable propensity not only to embrace new technologies but also to lead in the creation of new business solutions through silicon valley and other start-up ecosystems; ( ) e-receipt kpi and user behavior analysis: this line of research may focus on the identification of kpi and relevant user behavior analysis within the offline retail sme environment; together with the know-how to capture and extract such information in order to be able to take the appropriate decisions; ( ) investigate other e-receipt solutions and implementations: another area of opportunity is to research the technological components and platform solutions that could improve the application of e-receipt in smes. this line could describe the interaction between the modules and the ict requirements regarding the cloud platform, delivery, synchronization and retrieval of receipts; and ( ) how e-receipt empowers customers' privacy: this approach could evaluate the psychological and social consequences regarding customers' privacy in a digital context where all the information is publicly exposed, and how the e-receipt platform could empower customers privacy in providing opt-in and opt-out features regarding the treatment of their data. finally, this paper tries to envision the future of the offline smes but does not intend to limit itself only to the aspects described herein and invites future researchers to take the initiative on the results of this research and further develop them, extracting new knowledge regarding smes' digital transformation. table . position of non-it platform-based offline retailers as compared to it platform-based online retailers. own elaboration. non-it platform-based offline retail it platform-based online retail decisions based on intuition due to lack of supporting data. data-driven decisions supported by business data. slow reaction time based on observed occurring trends. fast reaction time based on early detection of trend patterns. reactive business actions. proactive business actions. under-utilized or non-existent customer behavior information. continuous customer behavior information collection. lack of customer behavior analysis tools. dashboards providing historical patterns and behavior analytics. semi-structured questionnaire used during the face-to-face focus group activity. own elaboration. focus area e-receipt discussion aspects discussion area e-receipt as digitalization enabler due to the use of software-as-a-service (saas) and cloud technologies-based e-receipt model, leading to new business opportunities, upgrades to new features, integration of sales analytics tools with less hardware and software maintenance. due to a deeper understanding of the customers based on the e-receipt collected analytics, habits and preferences, the companies can develop the most adequate communication channel or a mix of multiple channels, as best considered, creating shopping experiences regarding products or services, their added value, their impact on the environment and what kind of personalization is provided. as the e-receipt could provide an overall improvement of the market response, customer reaction time, stimulating proactive decision-making, within an improved data collection and detailed reporting process. due to the integration of customer analytics information from crm and the e-receipt platform in their business models, customers could obtain a more personalized product or service according to their needs, together with customized shape, color, format or delivery options. due to the creation of an additional mechanism to reach customers and engage them into the shopping process, such as e-receipt advertisement features where customers could receive promotions based on their real interests, which compared with the paper-based version would require a lot of resources, such as printing and distribution, and generate a lot of paper waste. as a tangible and economical approach to reduce business-activity-generated waste footprint, by means of using e-receipt digital copy the paper version is no longer needed, where the impact can be measured in economic terms using the cost of the paper as a reference index. cybersecurity stands as one of the most important topics within companies' digitization and digital transformation, where e-receipt cloud-based solutions are perceived as secure due to the datacenters' advanced cybersecurity resilience. on the other hand, the e-receipt solution is found to help improve customers' privacy, as they would be empowered to decide what commercial actions, such as analytics, advertisements, third-party information sharing, are subject to the data they generate, by means of automated and confidential opt-in and opt-out selection built within the platform. eight characteristics of successful retail concepts from tribe to facebook: the transformational role of social media mobile marketing: a contemporary strategic perspective the socially conscious consumer how the industrial internet of things changes business models in different manufacturing industries digital affordances, spatial affordances, and the genesis of entrepreneurial ecosystems social media marketing: how to build and execute your own social media strategy the impact of customer relationship marketing on the firm performance: a spanish case what coronavirus could mean for the global economy cómo cumplir la ley en el envío de sms masivos an introduction to social media marketing. an introduction to social media marketing. routledge adaptive personalization using social networks what's up with whatsapp? españa entre los países donde más descienden los ingresos por sms. xatakamovil working knowledge: how organizations manage what they know, choice reviews online clusters and entrepreneurship antecedents of b c channel satisfaction and preference: validating e-commerce metrics a social influence model of consumer participation in network-and small-group-based virtual communities social media marketing: strategies for engaging in facebook análisis estratégico para el desarrollo de la pyme en españa: digitalización y responsabilidad social. s.n embracing digital technology: a new strategic imperative desarrollo empresarial y redes sociales. el caso de las microempresas españolas definition of digital transformation -information technology glossary definition of digitalization -information technology glossary why sms marketing is crucial for your business four ways to outperform your competition on social media consumers' green commitment: indication of a postmodern lifestyle? how circular is the global economy?: an assessment of material flows, waste production, and recycling in the european union and the world in email marketing in the era of the empowered consumer the relationship of reputation and credibility to brand success cumplimiento legal. colección: protege tu empresa. spanish national cybersecurity institute, s.l ganar en competitividad cumpliendo el rgpd: una guía de aproximación para el empresario. incibe, s.l available at una guía de aproximación para el empresario how whatsapp is changing the way businesses work corporate communications, identity and image: a research agenda digital marketing handbook: a guide to search engine optimization, pay per click marketing, email marketing, content marketing, social media marketing how to use whatsapp for business - tips with examples likeable social media a model for evaluating the effectiveness of crm using the balanced scorecard the antecedent effects of sms marketing on consumer intentions elicitation and modeling non-functional requirements -a pos case study marco estratégico en política de pyme la responsabilidad social empresarial en la pequeña y mediana empresa dancing with whatsapp: small business pirouetting with social media consumer value co-creation in a hybrid commerce servicedelivery system the social construction of new marketing paradigms: the influence of personal perspective how smart, connected products are transforming companies capital projects and infrastructure (cpi): pwc. available at permission email marketing and its influence on online shopping the adoption of software-as-a-service (saas): ranking the determinants a typology of firms regarding m-commerce adoption. mobile commerce - adoption of software as a service (saas) enterprise resource planning (erp) systems in small and medium sized enterprises (smes) introduction to electronic commerce the economic effects of a pandemic since september has been working on multiple international research and development projects regarding virtual reality, data analytics, cybersecurity, air traffic management and unmanned/ drones traffic management within industrial applications at indra company his-academic experience includes: schools of tourism and economics, faculty of economics & business and polytechnic. he published books, coordinated studies on the information society and icts. elected president of the it sectorial area of ametic during - . more than twenty-five years of experience, working in consulting, services, industry and public administration (indra, tecnocom, everis and ibm, cemex and dod) key: cord- -qnkqckvm authors: yang, li; sun, li; wen, liankui; zhang, huyang; li, chenyang; hanson, kara; fang, hai title: financing strategies to improve essential public health equalization and its effects in china date: - - journal: int j equity health doi: . /s - - -x sha: doc_id: cord_uid: qnkqckvm background: in , china launched a health reform to promote the equalization of national essential public health services package (nephsp). the present study aimed to describe the financing strategies and mechanisms to improve access to public health for all, identify the strengths and weaknesses of the different approaches, and showed evidence on equity improvement among different regions. methods: we reviewed the relevant literatures and identified articles after screening and quality assessment and conducted six key informants’ interviews. secondary data on national and local government health expenditures, nephsp coverage and health indicators in – were collected, descriptive and equity analyses were used. results: before , the government subsidy to primary care institutions (pcis) were mainly used for basic construction and a small part of personnel expenses. since , the new funds for nephsp have significantly expanded service coverage and population coverage. these funds have been allocated by central, provincial, municipal and county governments at different proportions in china’s tax distribution system. due to the fiscal transfer payment, the central government allocated more subsides to less-developed western regions and all the funds were managed in a specific account. several types of payment methods have been adopted including capitation, pay for performance (p p), pay for service items, global budget and public health voucher, to address issues from both the supply and demand sides. the equalization of nephsp did well through the establishment of health records, systematic care of children and maternal women, etc. our data showed that the gap between the eastern, central and western regions narrowed. however the coverage for migrants was still low and performance was needed improving in effectiveness of managing patients with chronic diseases. conclusions: the delivery of essential public health services was highly influenced by public fiscal policy, and the implementation of health reform since has led the public health development towards the right direction. however china still needs to increase the fiscal investments to expand service coverage as well as promote the quality of public health services and equality among regions. independent scientific monitoring and evaluation are also needed. over the past years, the public health system in china has made significant progress to enhance health for the entire population. after the founding of the people's republic of china in , the chinese government made various innovations for better delivery of public health services. for example, at the beginning of s, china launched a village doctor training program to create a front-line workforce, providing public health services and essential medical services including clinical treatment and drugs [ , ] . in addition, disease prevention and primary care were the two most important tools at that time and people were able to receive some basic vaccines to prevent infectious diseases. all of these interventions lead to great health outcomes in china [ ] . however, the public health system was ignored due to the transition from the planning economy to the market economy in the s and s. the government funds in the public health sector declined, which led public health institutions to generate their own revenues (i.e. selling vaccines, providing more profitable services) [ ] . some infectious diseases such as tuberculosis (tb), re-emerged as a result of poverty and health inequities [ ] [ ] [ ] . fortunately, the chinese government eventually realized that issues in the health care system must be addressed (particularly public health) and made various corrections. after the severe acute respiratory syndrome (sars) pandemic, the chinese government paid more attention to public health and allocated more funds to public health sectors. in the health care reform policy, an essential public health package, including nine types of basic services and six types of catastrophic services, was launched. the pcis including community health care centers, township hospitals and village clinics provided basic services and the specialized public health institutions like centers for disease control (cdcs) provided catastrophic services. the government regulated the guideline for basic services and provided training for public health workers. the financial supports were shared by the central and the local governments. until , the package included types of basic services and seven types of catastrophic services. the budget per capita for basic services increased from renminbi (rmb) in to rmb in . almost every chinese citizen has equal access to this essential public health package. by summarizing china's experiences and lessons learned during development of both public health service systems and financing strategies, especially with regard to improving universal access, the present study will provide significant policy implications for public health development and health systems strengthening in other developing countries. health equity analysis was often used to assess the improvement of healthcare or public health equalization, which is concerned with four focal variables: health outcome, health care utilization, subsidies received through the use of services and payments people make for health care [ ] [ ] [ ] . the equity analysis methods include lorenz curves and gini coefficients, thiel index, the index of dissimilarity(id), the slope indices of inequality(sii), relative index of inequality(rii) and concentration index(ci) [ ] . since the policy has been implemented for only years, the process indicators instead of health outcomes will be mainly considered for effects measurement. because of data availability, we just measure the financing equity of essential public health services and summarize the experiences and lessons by using mixed methods. based on the theory of change, we formed a theoretical framework of public health financing. policy contents, including financing strategies for fund collection, management, and allocation, which could provide incentives for both the supply side and demand side and finally influence the outcomes and impacts. contextual factors will indirectly contribute to outcomes by affecting the policy contents (fig. ). the review included studies concerning china' public health equalization in either chinese or english on databases of pubmed, medline, china national knowledge infrastructure(cnki), and wan-fang data. in addition, the review is confined to studies concerning financing strategies which improve access to public health and health outcome from to in china. the keywords are:" public health equalization" or "public health" or "primary healthcare", and "revenue collect", or"fund collect" or "revenue manage" or"fund manage" or "revenue allocate" or "fund allocate" or "financing mechanism" or "health finance", and "population coverage" or "coverage rate" or "service content" or "service package" or "service items" or "access" or "availability" or "cost sharing" or "out of pocket" or "financial risk protection" or "catastrophic spending". policy articles or other documents and reports on public health revenue collection, management, allocation, or financing strategies for improving access to public health for all were included. two reviewers identified titles and abstracts of all articles from the search, and retrieved the full text articles. finally, we obtained a total of literatures studies after data screening. the following literature information has been collected from relevant studies including background, content, mechanism and effect of the policy interventions. the main results and conclusions in the reviewed studies have been extracted. we used mixed-method syntheses to summarize successful financing strategies to improve access to public health for all in the past years especially since nephsp policy in china [ , ] . we interviewed six experts in the public health field with semi-structured questionnaire, including two officials from china national health and family planning commission, two experts from national health account department at china national health development research center, one director from china community health association and one director from expand preventive immunization(epi) department in china cdc. . - h were spent for each interview. the questions for interview include: ( ) how long has you worked there? what was your duty at that department? ( ) why did china implement the public health equalization policy? ( ) what are the changes in public health? ( ) how was fund collected, managed and allocated? ( ) what were the provide side and the demand side's responsiveness on this policy? ( ) what are experiences or lessons for the policy implementation, which aspects still need improvement? we recorded it, coded it and conducted qualitative content analyses. we collected data from china health statistics yearbook, years of new china yearbook, national health service survey report, national health financial report, national health account report and global burden of disease (gbd) database by institute for health metrics and evaluation (ihme) at washington university in st. louis, united states. in addition, we searched secondary data on some non-governmental organizations (ngo) and government websites [ ] . by collecting data from above statistic reports and websites, we could show evidences on equalization process for essential public health financing and health indicators improvement since . we used gini coefficients through the slab method to assess the total financing equity for public health in china [ , ] . and calculated the thiel index to assess the financing equity among different regions [ ] . the results include three parts: ) reviewing the three phrases of public health financing evolution from to , ) summarizing the experiences and lessons of financing strategies learned during development of essential public health equalization and ) assessing effects on government public health expenditure, fig. conceptual framework expanded services coverage and narrowed the gap of health indicators between the urban and rural area. we generated the first part mainly by literature review, the second part based on literature review and key informants interview, and the third part based on literature review and second data analysis. equal access to basic services is one principle in the public health system of china. one of core policies is the free provision of basic public health services to all residents. with the development of the policy over the past years, china has achieved almost universal basic public health services coverage for its population of . billion with increased funding levels, expanded services, and enhanced financial equity. the experience from china can provide policy lessons for other developing countries. foundation for basic public health services: sustainable public funds as part of public health, public health financing should be responsibilities of various levels' governments. lacks of sustainable financing for public health will affect the access and equity of public health service. china has some lessons as well as experience in the past years. from to the present, china's public health financing has undergone three phases. planned economy period after the founding of the people's republic of china ( china ( - the central government collected funds to address major public health issues and launch the "patriotic health campaign", which effectively decreased mortality from infectious diseases and significantly improve health status for the entire population. the life expectancy at birth of the chinese people has been extended from years in , to years in , the world bank and the world health organization called it the "china model", characterizing this strategy as maximizing health benefits with limited costs, which could be applied across many developing countries [ ] [ ] [ ] . after national government budget reforms favoring decentralization and tax redistribution, chinese local governments failed to take full responsibility for funding the public health system. the government contribution to total public health expenditures decreased sharply. this weakened the role of pcis for the provision of public health services. in addition, the emphasis of public health institutions shifted to clinical treatment instead of prevention. without consistent financial supports from central budgets, the pcis were incentivized to become self-financing entities. because of the stagnation or even decline of basic public health service provision, some infectious diseases such as tb re-emerged [ , , ] . based on an idea of the "harmonious society", and people-centered political and social policies, the government plays more active roles in the public health system and attaches great importance to this sector again. expenditures for public health institutions and pcis are again funded by the national budget. in addition, the government has increased the overall investments in public health, enhanced the primary health care system, trained health workers, and promoted health development in rural areas [ , ] . equalization of essential public health services means every chinese citizen, regardless of their gender, age, race, occupation, place of residence, and income level, can receive the same essential public health services, as mandated and supported by the government. in view of the differences in people's needs for public health services, vulnerable groups such as low income people are given more attention [ ] . essential public health services are mainly provided by pcis including urban community health service centers (stations), township hospitals and village clinics free of charge [ ] . the current public health system in china includes a network of disease surveillance centers, professional public health institutions (such as tuberculosis dispensaries), , hospitals and , primary care facilities [ ] . in specialized public health institutions, government budgets fully cover staff salaries, construction and capital development, pooled general funds, and major public health campaigns such as control of acquired immune deficiency syndrome (aids), tb and endemic diseases. public hospitals undertake particularly required public health services that are publicly subsidized. as for pcis, the government allocates funds for human resources as well as construction and capital development by government budget. the government allocates operating funds by government purchasing service. before , the construction funds for pcis were mainly from subsidies of the central government, and the operational costs and personnel expenses were mainly from local governments' usual appropriation and medical services revenue generated by pcis themselves. the usual fiscal appropriation was not enough to pay for personnel expenses. in sichuan province, for example, the annual fund in rural areas was only . rmb per capita [ ] . the pcis lost money due to high services costs and these losses seriously affected their initiatives to provide more public health services [ ] . in , the new special funds for nephsp were added into the public health sector. the funds are managed by special transfer payments through china ministry of finance. cross uses between funds are not allowed any more by "earmarked" funding management system from top to bottom. the national, provincial, municipal and county governments allocate the funding to local fiscal sectors directly according to a per capita fund standard based on the total number of the resident population [ ] and the local fiscal sectors pay the pcis for providing public health services based on mixed payment of fix salary, pay for performance(p p) and capitation (fig. ) . details of the financing strategies for basic public health services in fund collection, management and allocation are discussed below. in , china launched the nephsp with nine items, including health records establishment, health education, immunization, child health, maternal health, geriatric health, hypertension and type diabetes management, severe mental illness management, and the surveillance and control of infectious diseases and public health emergencies. the service package has been continually expanded. in , health supervision and management was added. in , a regulation of traditional chinese medicine and tb management was added into the public health service package, which currently included a total of items (table ) [ ] [ ] [ ] . by service comparison we can see that not only the service items but also the coverage of essential public health services was expanded from to . for example, the target services group for children's systematic care extended from - years to - years. national clarification about the minimum service coverage has promoted the targeted provision of public health services and facilitated the process of assessment. in addition, local governments can add other public health services into this basic national package according to their local financial capacity and public health conditions. a national funding level was set by a standardized cost formula of each service item. the minimum funding [ , ] . the central government requires that every locality meets this minimum level, in order to guarantee implementation. province and municipality level governments can further supplement the funding level according to the content of their local basic public health service packages, cost of services and local financial capacity, which has helped to expand services in the package for many areas. for example, a study suggested that the cost of the package in beijing was rmb ( . usd) per capita in based on survey in sample centers and model estimation [ ] . national, provincial, municipal and county governments in china share responsibility for funding basic public health services, and the national government allocates more money to less-developed middle and western regions by transfer payments. the proportions contributed by governments at different levels vary among regions, partially based on local socio-economic status. funds allocated from the central government via general or special transfer payments account for % of total basic public health expenditures in western regions, % in central regions, and only - % in the more prosperous eastern regions. this helps to alleviate funding disparities and gaps in western and central regions [ ] (table ) . similarly, the provincial governments can cross-subsidize counties by transferring funds from richer to poorer areas by transfer payments. taking the minimum public health funding level of rmb per capita as an example, contributions to western regions from the national, provincial and local levels of government were rmb, rmb and rmb respectively. by comparison, only rmb was from the national government in central regions. in eastern areas, the majority of the rmb minimum came from local governments [ ] (table ) . public health funds in china are managed as 'special financial funds' , which means they are managed as ringfenced budgets with unified accounting and strict allocation by capitation. this strong transparency in allocations can effectively reduce issues of payment delay or fund misappropriation. moreover, it can help improve direct supervision of public financial departments, ensuring that disbursements are not impeded and flow smoothly and securely in the health system. there are mainly two ways in the disbursement of funds for essential public health services. the first is that central and provincial project funds are directly appropriated by the provincial finance departments to municipal and county finance departments. the county finance departments allocated funds to pcis in accordance with the results of the performance evaluation. the second is the establishment of municipal finance centralized payment accounts. municipal finance departments directly allocated funds to pcis. take tianjin city as an example, municipal and district governments match funds that are then turned in to the municipal finance centralized payment accounts and allocated directly to community health service centers. municipal finance department keep accounts alone and do not adjust the use of funds. municipal and district health boards take the responsibility of supervision [ ] . this can ensure funding allocation in place and in time. in order to avoid problems from the delay of disbursements and ensure the effectiveness of funding for basic public health services. a large proportion ( %) of public health funds are allocated by capitation at the beginning of each fiscal year. according to the performance assessment system, subsequent funds are linked to the facility's actual delivery of services, which includes organization and management, responsible use of funds, productivity in completed tasks, quality, timeliness, socio-economic benefits, sustainable impact, social satisfaction, and other metrics. these payments can therefore increase the incentives to provide basic public health services in primary health care facilities and ensure funds are spent as intended by policymakers. the special fund for essential public health services were allocated by government procurement. government procurement of public health services refers to the following two ways, government proposes specific tasks, objectives, requirements and assessment criteria, and pcis provide free essential public health services to people. the government allocated the public health fund in terms of seven kinds of financial payment methods [ ] : capitation, line budget, salary, pay for performance [ , ] , global budget [ , ] , fee for service [ , ] and public health voucher [ , , ] . actually mixed payment methods were often used in practice. the government also purchase the public health services by signing a contract with the private sector such as village doctors and the latter receive a modest subsidy for providing public health services associated with the package. the willingness of village doctors to provide public health services has been improved since the introduction of the package and a minimum subsidy, although village doctors do not find the subsidy to be sufficient remuneration for their efforts [ ] [ ] [ ] . government procurement of services and publicprivate partnerships (ppp) can improve incentives in the private sector and alleviate shortages of health workers in public facilities. before the current policy of essential public health service equalization, public funds were only available for staff salaries but not institutional management. as a result, strategic performance of the public health services suffered. after adoption of the policy, pooled government procurement of services has led to greater purchasing efficiency for public health services. health workers in pcis are additionally more motivated, because their compensations are linked to performance assessment. furthermore, the government can purchase services provided by private sector actors such as village doctors, in order to effectively alleviate public health workforce shortages. the evaluation system of nephsp policy can effectively evaluate, interpret and improve basic public health services. hu shanlian initially established the evaluation indicators for this policy by consulting with experts, relying on the conceptual framework of the health system financing [ ] . yu yong combined the evaluation indicators with "national essential public health service standards" ( edition) to effectively evaluated current policies [ ] . both process indicators and outcome indicators are used to evaluate nephsp policy. process indicators are mostly service utilization indicators, used to measure the process effects of resources allocation. outcome indicators are used to reflect the final outcomes of the resource allocation. since only years for this policy implementation, process indicators are often used in current empirical studies [ ] [ ] [ ] [ ] [ ] [ ] . the improvement of government public health expenditure equity [ ] . measured by the gini coefficient, we found that inequality in ghe fell from . ( ) to . ( ), and inequality in gphe fell from . ( ) to . ( ) . measured by the theil index, the gap of ghe between eastern, central and western areas has narrowed sharply since (fig. ) . in , adoption of standard electronic health records has reached to more than %. systematic coverage rates of public health care for children under years old and maternal women are above % (fig. ) . the coverage rate for people over years old remains at % while the immunisation rate among school-age children is above %. standard management of hypertension and diabetes has reached . million and . million patients respectively, in an equivalent to management rates of % and %. meanwhile, the standard management rate of registered patients with severe mental disorders has reached to % and % of patients covered by traditional chinese medicine health care. nine million tb patients, or % of total tb patients in china, are successfully managed. the hospitalized delivery rate among rural pregnant women has reached to % [ ] . the narrowed gap of health outcomes between urban and rural area as to outcome indicators for systematic care for children under and maternal women, the mortality for children under and maternal women decreased sharply in - , especially in rural area, after . the gaps between urban and rural areas have significantly narrowed since , as shown in fig. . as to outcome indicators for systematic care of patients with hypertension and diabetes, the mortality of ischemic stroke and ischemic heart diseases increased in - , except the mortality of haemorrhagic stroke has decreased since , and mortality of diabetes increased slightly since (fig. ) . as we know, the hypertension is the leading risk factor of haemorrhagic stroke (rr = . ) [ ] . total cholesterol (rr = . ) and triglycerides(male: rr = . , female: rr = . ) are more contributed to ischemic stroke compared with blood pressure (rr = . ) [ , ] . considering the control of dyslipidaemia is not included in the nephsp, it's easy to understand that the mortality of haemorrhagic stroke this public funding is nevertheless not enough in pcis. current workforce shortages and weakness in capacity will affect the quantity and quality of services that can be offered [ , , ] . in addition, local governments may lack the capacity to effectively assess performance in terms of productivity and/or quality. service coverage and financing mechanisms for china's migrant population (approximately million in ) also need to be improved. although many studies proved that the causal association between the public health expenditure and infant or child mortality [ , ] , some studies well summarized china's experience on public health in - [ , ] and lessons in - [ , ] , some studies assessed the effects of nephsp on service coverage and equity [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , very few studies described china's financing strategies and mechanisms for the nephsp [ , , , ] . this study could be an important contribution to the exiting literature on evaluation of public health equalization in china. china's experience of different financing strategies for public health shows that the public health sector can develop stably and sustainably only if the responsibility of governmentespecially at the national levelfor financing is emphasised. in fact, the policy of basic public health services equalization was not a novelty, but rather the re-establishment of public financing responsibility and governance in china, in order to set a mechanism for equity in financial and service provision. developing countries that rely on the national budget and/or international aid to mobilise resources for health expenditures can learn from china's experiences [ , , ] . however, it is worth noting that public health financing in china is influenced strongly by its unique national governance and public financial management. strengthening the government's leading role in public health financing the chinese national government has introduced a clear and basic service package and clarified the service content, standards, and minimum financing levels, which has led to better health sector accountability [ ] . the national government plays the main role in public health financing, and local governments should continue to be clear about their financing responsibilities. financial equity across citizens and regions can be guaranteed by transfer payments facilitated by national or provincial governments [ , ] . the national government sets policies for subsidy management, allocates central funds, and implements the management hierarchy across levels. integrated payment management to ensure full and timely funding is in place earmarked funding and allocation by capitation can increase transparency of funding levels, which can safeguard against the delay or diversion of funds [ ] . top up disbursement for actual services according to recurrent expenditure management can improve incentives in pcis [ ] . with this combination of preappropriation and later payments based on performance assessment, the process of disbursements can be accelerated to meet operational needs. moreover, government procurement of services can promote ppp, to improve incentives for private sector actors to provide public health services as a supplement to public institutions [ , , ] . according to local conditions, in terms of funding criteria as well as implementation schedule and goals, it is essential to continuously improve the health system [ ] . in a large country with significant regional diversity, the key point is to increase local governments' incentives to promote equity of basic public health services [ ] . it has been only years since the carry out of nephsp equalization policy in , it is difficult to use the data to measure the improvement of health outcomes and health equity in the public health sector. we need to use longitudinal data to capture its effectiveness in future. however based on existing evidences we could find that many process indicators has improved since which may finally result in improvement of health outcomes based on many experimental studies [ , , ] . financing strategies are essential parts in the public health equalization policy. public fiscal policies have a major effect on the delivery of essential public health service. in many middle or low income countries, people couldn't acquire or have equal access to basic public health services due to the lack of sustainable public financing, which result in major infectious diseases and endemic diseases spreading, high maternal mortality and mortality of children, finally preventing the realization of mdg. the chinese public health financing evolution proved that equalization of health outcomes depends on fiscal equalization, health financing equalization and equal access to public health services. and chinese experiences for nephsp could provide lessons for other developing countries. abbreviations aids: acquired immune deficiency syndrome; cdcs: centers for disease control; gbd: global burden of disease study; ghe: government health expenditure; ihme: institute for health metrics and evaluation; nephsp: national essential public health services package; ngo: non-governmental organizations; p p: pay for performance; pcis: primary health care institutions; ppp: public-private partnerships; rmb: renminbi; rr: risk ratio; sars: severe acute respiratory syndrome; tb: tuberculosis transformation of china's rural health care financing state council of the people's republic of china. regulation on the practicing of village doctors good health at low cost' years on: what makes a successful health system? london: lshtm china's public health-care system: facing the challenges health sector reform: lessons from china regulating health care markets in china and india expanding health insurance coverage in vulnerable groups: a systematic review of options analyzing health equity using household survey data a guide to techniques and their implementation the effect of private and public health expenditure on infant mortality rates: does the level of development matters? child mortality and public spending on health: how much does money matter? world bank policy research working paper protocol: a realist review of user fee exemption policies for health services in africa proposal: a mixed methods appraisal tool for systematic mixed studies reviews institute for health metrics and evaluations. global burden of diseases compare empirical study on the equality of public health service in china: analysis and evaluation of public health voucher in chongqing municipality thinking about years of public health in new china public health in china-is the experience relevant to other less developed nations? socsci med financing reforms of public health services in china: lessons for other nations historical evolution and current situation analysis of the construction of rural public health system in china historic evolution and problems of public health service system in china china's rural public health system performance: a cross-sectional study historic evolution and problems of public health service delivery mechanisms in rural areas in china feasibility research on the national essential health service package in china national bureau of statistics. statistical bulletin of the national economic and social development in surveying the implementation of primary public health services in rural sichuan the analysis of regional equalization of public health services in china -based on the prospective of public health expenditure and public health resources national basic public health service specification national basic public health service specification national health and family planning commission. national basic public health service specification national health and family planning commission. notice on the national basic public health service project in a model to estimate the cost of the national essential public health services package in beijing opinions on promoting the gradual equalization of basic public health services" issued, the vice minister of finance proposed to grasp "the three outstandings implementation progress of equalization of essential public health services and its countermeasures study on the financial share and compensation mechanism of the basic public health services in chongqing fiscal policy of promoting the equal basic public health services. the journal of science and technology to become rich wizard policy analysis of government purchase of public health service at el. problems and countermeasures of basic public health special funds management of primary health care institutions payment method research of basic health services payment method research of the basic health services institutions study on equalization of basic public service in urban and rural areas. taxation and economy discuss of cost estimation and financial security mechanism in community public health service in hunan province factors influencing the provision of public health services by village doctors in hubei and jiangxi provinces china evaluation and mechanism for outcomes exploration of providing public health care in contract service in rural china: a multiple-case study with complex adaptive systems design health providers' perspectives on delivering public health services under the contract service policy in rural china: evidence from xinjian county indices of the equality of essential public health services in china construction of evaluation index system for equalization of basic public health services china's rural public health system performance: a cross-sectional study differences and determinants in access to essential public health services in china: a case study with hypertension people and under-sixes as target population public health in china: the shanghai cdc perspective essential public health services' accessibility and its determinants among adults with chronic diseases in china determinants of basic public health services provision by village doctors in china: using non-communicable diseases management as an example evaluation of health care system reform in hubei province, china national health and family planning commission progress report of the state council on deepening the reform of health system subtypes of hypertension and risk of stroke in rural chinese adults guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the challenges of basic public health services provided by village doctors in guizhou, china revisiting current "barefoot doctors" in border areas of china: system of services, financial issue and clinical practice prior to introducing integrated management of childhood illness (imci) research on the fiscal policies of equalization of basic public health services in hebei province dr. meng qingyue is the pi of this study and provides guidance and supervision to the study design, analysis and manuscript writing. the dataset supporting the conclusions of this article is included within the article. all authors read and approved the final manuscript.ethics approval and consent to participate not applicable. all authors jointly contributed to the design, analysis, and interpretations of results. all authors read and approved the final manuscript. the authors declare that they have no competing interest.• we accept pre-submission inquiries • our selector tool helps you to find the most relevant journal submit your next manuscript to biomed central and we will help you at every step: key: cord- -t aqcvu authors: carneiro, vera lúcia alves; andrade, helena; matias, luísa; de sousa, raul alberto ribeiro correia title: pos covid- and the portuguese national eye care system challenge date: - - journal: j optom doi: . /j.optom. . . sha: doc_id: cord_uid: t aqcvu abstract the pandemic of the severe acute respiratory syndrome disease caused by the new coronavirus sars-cov- (covid- ), had profound impact in many countries and their health care systems. regarding portugal, a suppression strategy with social distancing was adopted, attempting to break the transmission chains, bending the epidemy curve and reducing mortality. these measures seek to prevent an eventual national health service over-running, enforcing the suspension of all elective and non-urgent health care. despite the success in so far, there is a consensus on the need to recover the previous level of health care provision and further enhance it. the portuguese national health service, as a public, universal access, health care system funded by the state proved, in this context, its importance and relevance to the portuguese population. however, long standing issues, such as the pre pandemic over long waiting lists for hospital ophthalmology attendance, whose determinants are fully identified but still unmet, emerge amplified from this pandemic. the lack of primary eye care in the national health service is a significant bottleneck, placing a huge stress on hospital-based care. an exclusive ophthalmologist’s centre care was over-runned before pandemic and will be even more so. the optometrist’s exclusion from differentiated, multisectoral and multidisciplinary eye care teams remains the main hurdle to overcome and insure universal eye care in portugal. national health service highlights the consequences of an overcome model. universal eye care more than ever demands an evidence-based, integrated approach with primary eye care, in the community, on time and of proximity. la pandemia del síndrome respiratorio agudo grave causado por el nuevo coronavirus sars-cov- (covid- ) ha tenido amplias repercusiones en muchos países y en sus sistemas sanitarios. en portugal, se ha adoptado una estrategia de contención basada en el distanciamiento social, con la cual se ha intentado cortar las cadenas de transmisión, frenar la curva de la epidemia y reducir la mortalidad. con estas medidas se trataba de evitar un eventual desbordamiento del servicio nacional de salud y se imponía la suspensión de toda la atención médica programada, que no fuera urgente. a pesar del éxito logrado hasta este momento, existe consenso sobre la necesidad de recuperar el nivel anterior de atención médica y fomentar su mejora. el servicio nacional de salud de portugal, como sistema sanitario público y de acceso universal, a cargo del estado, ha demostrado, en este contexto, su importancia y pertinencia para la población portuguesa. sin embargo, los problemas que acarrea desde hace mucho tiempo, como las largas listas de espera, anteriores a la pandemia, en la asistencia oftalmológica hospitalaria, cuyos factores determinantes están completamente identificados, pero que continúan sin solución, se han visto agravados a resultas de esta pandemia. la falta de atención primaria oftalmológica en el servicio nacional de salud es un importante cuello de botella, que ejerce una enorme presión en la atención hospitalaria. la atención de un centro exclusivamente oftalmológico estaba desbordada antes de la pandemia y lo estará aún más después de esta. la exclusión de los optómetras de los equipos de atención oftalmológica diferenciados, multisectoriales y multidisciplinarios continúa siendo el principal obstáculo que debe superar y asegurar la atención oftalmológica universal en portugal. el servicio nacional de salud hace hincapié en las consecuencias de un modelo superado. la atención oftalmológica universal exige, más que nunca, un enfoque integral basado en la evidencia para abordar la atención primaria oftalmológica en la comunidad, puntual y de proximidad. covid- , atención oftalmológica, portugal, acceso universal, optómetras, oftalmólogos early this year it became obvious that the severe acute respiratory syndrome disease caused by the new coronavirus, sars-cov- , (covid- ) would translate into a pandemic, already having almost million infected people identified and more than thousand deaths. in addition to the symptomatology associated with the respiratory and digestive systems, ocular symptomatology such as hyperemia and conjunctival congestion are also identified. however, more evidence is needed to determine the ocular effects presented in covid- or its ability to first suspect covid- . since the expression of the receptor for sars-cov- , an angiotensin-converting enzyme (ace ), , seems to be concentrated in type ii alveolar cells, a rapid and unique transmission by infected individuals through droplets in contact with deep lung tissue was speculated. however, and as the airways where type ii alveolar cells are located are not reachable by respiratory droplets with a diameter greater than micrometers, seems likely that at least the most severe cases of covid- with viral pneumonia result from airborne events. the continuity between the ocular tissues and the upper respiratory tract, as well as the existence of ace receptors on the ocular surface, makes eye protection indispensable in the provision of proximity health care, less than two meters away, through protective goggles or face shield, in addition to the normal personal protective equipment that includes gloves, medical mask and gown. , as measures to prevent the spread and contagion by the sars-cov- in portugal, it was decreed schools' closure on march and the emergency state declaration, with border control and closure, on march . portugal has thus tried to adopt a suppression strategy, that is, an attempt to break the transmission chains, slowing the epidemy propagation and reducing the incidence to the smallest possible. a zero-growth rate in the covid- incidence is compatible with the effectiveness of measures of distancing and social isolation, as well as of the measures of hygiene and respiratory etiquette. still, the growth in the prevalence continues, and although the data supports the claim that the incidence peak has already been reached, it is yet to be reached the prevalence peak in portugal. despite variations in duration, size and phase, the european context is of community spread and virtually all european countries are currently in the community transmission mitigation phase. the identified limitations of the human, material and organizational resources of the portuguese national health service (serviço nacional de saúde) and the alarming expectation of an eventual national health service over-running by a significant number of infected people, implied the suspension of all elective and non-urgent health activity, namely in the primary care level, scheduled hospital interventions and community care, which adds to the decrease of the urgent and emergent activity care due to the fear of contagion felt by the patients. the current strategic objective of the portuguese health general-director is to mitigate the risk to public health, patients, and professionals, and at the same time to avoid the national health service collapse. still, despite how worrying public health situation is, there is a consensus on the need to recover the previous level of health care provision, otherwise the effects of other untreated illness can be even more harmful. nevertheless, a possible second peak is a circumstance to be considered, as a result of the relaxation of the measures to restrict circulation, internal and external, and less social distancing. it is also important not to lose sight of the fact that the different national health services in all countries have been under enormous pressure, not because of the relatively low lethality rate, but above all because of the very high incidence of covid- on the population. italy's experience, for example, supports the idea that in the case of full use of intensive care resources, the lethality rate increases significantly. therefore, prudent and informed planning is essential to contain contagion, safeguard health services and consequently limit the lethality rate. until group immunity is achieved in portugal, either through vaccination or through possible acquired immunity, the recovery of health care provision must be framed in the current epidemic situation with community spread contagion, as well as contagion by foreigner source. this implies adjusting organizational and clinical management procedures, individual therapeutic and diagnostic equipment, physical spaces, and management of the circulation of patients and professionals in the spaces of access to the health care facilities. in the eye care provision, protection measures, procedures, and personal protective equipment, acquire special importance in this new context. similarly, this pandemic situation is further evidence of the direction that health services should follow, focusing on a community and proximity-based care. an approach where primary, timely and preventive care is provided, enhances the first contact between the health provider and the community, in an integrated care provision through all the different health care levels. thus, it would be possible to filter what can be attended and solved in primary eye care, and leaving the necessary curative and reactive approach to highly specialized, secondary and tertiary care, safeguarding physical and human resources. the differentiation and separation of the current health organizational model, in a real primary or community, secondary or hospital and tertiary care, duly established and communicative bottom to top, would also constitute a barrier in the propagation and contagion of conditions such as covid- , without the need to completely suspend the provision of health care. it would allow the sorting patients within the community and in a proximity way, without the typical agglomerations of hospital services and observing the limitations of travel within the system and contact inherent. the significant financial burden borne by the state, inherent to the purely specialized secondary and tertiary services, would also be reduced. by all these arguments, it is important to note that this is a moment of change and to create the formal rationality that the national health service has just suffered a temporal division: the prepandemic era and the post-pandemic era. looking on the positive side, the national health service as a public, universal access, health care system funded by the state proved, to those who still had doubts, its potential and responsiveness when mobilized and provided with the appropriate resources and organization. the essence of the national health service, its mission and its values serve a greater purpose and demonstrate in this context its importance and its relevance to the society, assuming itself as possibly the most important organization at national level. and that is precisely why it is important to highlight the need to provide access to a broad scope of health care services within the national health service, to ensure its functionality, its safety, its effectiveness, and its efficiency. also, national health service should be reformed, reorganized, complemented, and adapted to population needs, which are dynamic and changeable over time. all of this, considering differentiated approaches according to population demographic evolution, epidemiological data, and scientific evidence, focusing care on patients and population needs. the lack of primary eye care in the national health service and inadequate planning of the eye care workforce are the central constrains, highlighted during and pos pandemic crysis. , also, it is pointed that about sixty percent of the portuguese eye conditions could be manage at primary care level, since they are technical simple and would free hospital resources from less differentiate tasks. the portuguese ophthalmologist-only eye care model is known to be ineffective and expensive use of eye care resources, that could be allocated and better used in surgery and pathology management. a comparison with the uk ophthalmologist-optometrist model clearly evidences portuguese shortcomings. as a result of not implementing the recommendations of the world health organization, good practices and scientific evidence, a difficult pre-pandemic situation suddenly escalates to a defiant pandemic and post-pandemic situation. it is enough to consider the elderly on their visits to the hospital to obtain a simple prescription for glasses, knowing that they are in the age group with higher prevalence of refractive errors and also have higher risk of exposure to contagion, and risk of death outcome. the approach to eye care provision must follow the same orientation of the other health care, differentiated by levels, primary and secondary, integrated in the community, protecting, and promoting the eye health. eye care at primary level should be evidence based, preventive and proactive, contrary to the curative and reactive action of secondary and tertiary care. [ ] [ ] [ ] the same recommendations are made by the world health organization and for which there is a global action plan. , the creation of primary care platforms for the eye care, properly integrated in the current primary care network, taking advantage of the existing logistics and material resources and using the highly qualified human resources trained nationally by portuguese universitiesoptometristsis one of the proposed solutions for solving a chronic national health service problem and that the pandemic scenario has accentuated. lourenço and pita-barros study concludes that it will suffice to address in primary eye care only twenty-five percent of all references to secondary hospital specialty of ophthalmology to immediately eliminated waiting lists. this would provide resolution of primary care conditions, as are refractive errors, accommodative, vergence and oculomotor dysfunctions, as well as the screening and follow-up of pathologies such as retinopathies, would allow a screening of primary care users and immediately solving the problem of most patients. providing primary eye care from the perspective of proximity and community would minimize the patient travel and waiting time to access the national health service, making it safer, more effective, and more efficient. a recently published study shows that the delay in the use of primary eye care provided by optometrists is associated with a greater probability of resorting to general practitioners, as an indicator of missed opportunities to detect potentially serious eye conditions. it is emphasized that this study reflects on the pre-pandemic period, so the consequences during and postpandemic are expected to be substantially greater. the impossibility of maintaining current practices regarding eye care provision challenges in the portuguese national health service, imposes a paradigmatic shift that breaks with previous overcome practices and with the permanent insufficiency in the provision of this care. more than implementing a better cost-benefit practices, which is consensually assumed and accepted, a change is required that protects public health, patients and professionals, that provides care where is needed, when is needed, with reduced contagion exposure and effective, simple and direct response to the patient needs. scientific evidence, recommendations of relevant organizations and entities and good practices , [ ] [ ] [ ] , as well as the analysis of socio-economic impact , are clear and point to the same solution: a national health service should be based on a solid primary, differentiated, multisectoral and multidisciplinary care, and with regard to primary eye care, should be provided, by definition, by the optometrist. more important than the reform of the national health service, which has proved to be a matter of significant challenge, this period requires a reform of thought and the disconnecting of obsolete and ineffective practices. with regard to the eye care, who timeline -covid- clinical characteristics of coronavirus disease in china discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin functional assessment of cell entry and receptor usage for lineage b βcoronaviruses, including -ncov single-cell rna expression profiling of ace , the putative receptor of wuhan -ncov. biorxiv transmission of influenza a in human beings seasonality of respiratory viral infections dgs. orientação / : prevenção e controlo de infeção por novo coronavírus dgs. novo coronavírus | covid- utilização de equipamentos de proteção individual decreto n. o -a/ -diário da república n. o / , o suplemento, série i de - - world health organization. declaração de alma-ata estudo para a universalização de cuidados de saúde da visão em portugal estratégia nacional para a saúde da visão ophthalmologists and optometrists -interesting times? a reforma dos cuidados de saúde primários e a reforma do pensamento. rev port clínica geral who. primary health care: now more than ever essential components of primary eye care world health organization. who | universal eye health: a global action plan - . world health organization delayed attendance at routine eye examinations is associated with increased probability of general practitioner referral: a record linkage study in northern ireland world health organization towards a better world -optometry's role" -world council of world health organization. strategies for the prevention of blindness in national programmes:a primary health care approach and anticipating the difficult post-pandemic scenario, only a solution that takes advantage of the human and material resources already existing in the country and that does not submit to the economic and corporate interests is acceptable. key: cord- -xx w c authors: sarder, md title: logistics customer services date: - - journal: logistics transportation systems doi: . /b - - - - . - sha: doc_id: cord_uid: xx w c this chapter discusses customer service in logistics in terms of different elements, the relative importance of those elements, and how these elements impact the effectiveness of logistics operations. it also explains the sales–service relation model and how to measure service level. other topics include order cycle time, how to determine optimal service levels, and acceptable service variation in logistics. such as transport planning, scheduling, and modal selection. there are also strategies involving location analysis and the networking planning. all these strategies are critical for an effective logistics customer service ( fig. . ). logistics planners need to focus on certain approaches and and features to ensure a good customer service experience. such approaches include building up a strategic process to provide highly valued services to the customers, on-time deliveries, ensuring trade-off between costs and services, maintaining a harmonious relationship among all supply chain partners, continuously improving customer loyalty, and customer satisfaction as well as bringing the competitive environment in the market (fig. . ). logistics customer service is a part of a firm's overall customer service offering, customer service elements that are specific to logistics operations including fulfillment, speed, quality, and cost. the term fulfillment process has been described as the entire process of filling the customer's order. the process includes the receipt of the order, managing the payment, picking and packing the goods, shipping the package, delivering the package, providing customer service for the end-user, and handling the possible return of the goods. the term "customer service" needs clear explanation in order to relate with logistics. for example, manufacturers' first concern always is with how efficiently the cargo reaches its destination without any delay or any sort of complication. this is important because of the reputation of the company, which solely depends on customer perception. businesses flourish based on the manufacturer's capability of meeting these customer expectations. one approach to maintaining good logistical support and cutting costs is to concentrate on communication solutions such as tracking shipment, status update, and accommodating last minute change request. with the advancement of technology, many services are available to the customer by limiting confusion, ambiguity, and inefficiency. as a result, these services such as shipment tracking helps not only pushes away unnecessary expenses out of the manufacturer's existing operational exercises, but also increase the overall customer experience and helps improve financial aspects. some technology driven service goals are described as follows: g automate timing/location updates, rate quotes, pick-up scheduling, current transit times, or proof of delivery with interactive voice response (ivr) self-service. g provide inquiries about updates regarding service and measures the needs of service calls within the system. g generate and deliver notifications, such as weather alerts, changes in schedules, and more with campaign management tools to alert the respective personnel. g provide security of overall customer information and payment transactions and minimize fraud. g empower customers by providing information regarding the purchased products so that they can express and communicate better their expectations. g identify and predict customer interest to make every smooth interaction between the customer service provider and the customer. continuously enhance policies and approaches through gathered customer feedback data and analyze and make reports for executing better business strategies. g ensure customer reliability and a consistent experience for clients by avoiding unnecessary costs and improving workforce development. logistics planners must understand all logistics services offered by the firm so that they can articulate the benefits to the customer. if articulate properly, customer service could add significant value to create demand for the products and improve customer loyalty. customer service starts with order entry of the product from the inventory to the transport of the final product to the desired destination. well-organized customer service logistics focuses on providing technical support as well as required equipment service maintenance. as mentioned earlier that customer satisfaction depends on the speed and efficiency of ensuring the availability of the product ordered and delivered. the following sections describe the different elements of customer service. customer service has several integral parts, which are interconnected with each other, such as price, product quality, and speed of service. for instance, the price goes up with higher speed of service and vice versa. there are four valuable marketing mixes such as product, price, promotion, and place, which are combinedly elaborated as four ps. the "place" is associated with physical distribution, which means it involves customer service. a study on customer service by the national council of physical distribution management identified these elements of customer service according to when the transaction between the supplier and customer take place. these elements are categorized as pretransaction, transection and posttransaction. according to lalonde and zinszer, there are three elements to customer service. the first one is the pretransaction element. this element establishes the business relationship climate. ideally, all terms of customer service policy are identified prior to shipment of goods that establishes an expected level of customer service in the transaction. the pretransaction element consists of returns policies, expected delivery time, and contingency plans for problems that may occur during shipment. the expectations are established during the pretransection stage, but it is important for companies to adhere to established policies. the second element of customer service occurs during the transaction stage. this element is very simple. companies must deliver the right product to the correct location in the prescribed delivery time. also, the product received must be in good condition. lalonde and zinszer identified the third element of customer service as posttransaction activities. these are the services provided to customers following receiving their goods. these activities must be planned in the pretransaction and transaction stages (ballou, ) . these elements are shown graphically in fig. . . in the corporate business climate, all these elements are considered individual components of the larger overall customer service. there have been several studies, such as the works of innis and lalonde or sterlingÀlambert, which indicate that while all these individual elements do make up the overall customer service, some elements are considered more important than others. innis and lalonde concluded that as much as % of desirable customer service attributes can be directly attributed to logistics (innis & lalonde, ) . these include fill rates, frequency of delivery, and supply chain visibility (innis & lalonde, ) . researchers have consistently discovered that customer service is highly dependent on logistics. fig. . summarizes the most important customer service elements as on-time delivery, order fill rate, product condition, and accurate documentation. pretransaction elements of customer service mean to establish a climate for good customer service. which is basically a nonroutine activity. this element of services deals with the service level and related activities in qualitative and quantitative terms. pretransaction elements provide the roadmap to the operating personnel regarding the tactical and operational aspects of customer service activities of the company. for the reverse logistics process, this phase is essential because it helps to shape the firm to focus on customer such way to create influence the perception of the firm into the customer's mind. transaction elements include everything between a order is received and delivered to the customer. during the transaction phase of customer service, a firm focusses on retrieving, packing, and delivering the order to the customer in a timely and cost effective manner. this phase also includes scheduling of shipment, communication with the customer, delivery tracking, and delivery confirmation. this phase represents the array of services needed to support the product in the field; to protect consumers from defective products; to provide for the return of packages; and to handle claims, complaints, and returns. corporate customer service is the sum of all these elements because customers react to the overall experience. according to studies of sterling and lambert, most of the industries show that buyers, customers, and influencers of purchases of related industries mainly focus on variables including product, price, promotion, physical distribution, and speed of delivery among others. sterling and lambert clearly showed in their research that logistics customer service is the critical factor for the office systems as well as plastic and furniture factories. factors such as high fill rate, frequent delivery, detailed inventory visibility, estimated shipping date, and expected delivery time from the time of order placement and order received are very important to the retail customers. in the surveys of purchasing and distributing suppliers, presented by shycon associates, there are several common service failures including late delivery, faulty products, damaged goods, and discontinued products. late delivery is the most critical issue, as it represents % of the entire customer complaints. again, faulty products fall around one-third of the total complaints. fig. . shows some of the most common customer service complaints noted by industrial surveys. the following are considered the most important logistics customer service elements: in logistics, it is said that nothing happens until somebody orders something. "order cycle time is defined as the elapsed time between when a customer order, purchase order, or service request is placed and when the product or service is received by the customer" (ballou ) . logisticians can affect the overall customer service level through efficient management of operations. the cycle time of each order must be carefully monitored to properly judge the efficiency within each cycle. therefore order cycle time is considered all the processes that must occur prior to the customer receiving their product or service. total order cycle time includes order transmittal time, order processing and receiving time, stock acquisition time, and delivery time. order processing and receiving time includes the bill of lading preparation, credit clearance, and order assembly times. however, the delivery time has three basic components: shipping time from the plant, shipping time from the warehouse, and customer shipment process. fig. . shows the various components of a typical customer order cycle. depending on the system used for communicating orders, the transmittal time varies. the transmittal time includes transferring the order request from the origin to the entry of the order for further processing. order entry may be handled manually such as physically carrying the order or electronically via toll-free number, satellite communication or via the internet. the manual processing is slow but inexpensive, while the electronic methods are most reliable, accurate and fast but expensive. the next important element of an order cycle is the steps required for order processing and order assembly. these processes are involved steps like send notifications to the buyer/supplier, updating inventory records, preparing and scheduling shipping details for delivery, and communicating with customers as priorities can affect or change the speed of order processing for delivery. to some extent, order processing and assembly occurs concurrently to save time for both of these operations. unavailability of stock has a significant negative effect on total order cycle time, as it takes searching for the stock items, reconciling missing items, and delays in order assembly. the final primary element in the order cycle over which the logistician has direct control is the delivery time, the time required to move the order from the stocking point to the customer location. order cycle time can be adjusted for various reasons including the changes in customer needs, order priorities, shipping capacities, promotions, among others. a customer may chose to change the order delivery time by paying for an expedited service anytime after placing the order. it is normally assumed that the elements of the order cycle have remain unaffacted, but customer service policies and disruptions may distort the normal order cycle time patterns. such as priorities of order processing, condition of the order, size of the order, natural disaster, etc. priorities of order processing are determined by factors including delivery time and window, premimums paid by the customers, urgency of ontime delivery, consequence of late delivery, customer reputation, and many others. when backlogs in the order cycle occur, it is required to distinguish orders from each other. an individual customer may vary greatly from the company standard, depending on the priority rules, or lack of them, that have been established for processing incoming orders. typical order cycle time may change significantly for the goods delivered in their destinations as damaged or unusable. in that situation order cycle time significantly increase as reorder, replacement, or repair has to happen. depending on the factors for setting standards for the packaged goods including design, returning and replacing processes if needed for the incorrect, damaged goods, the cycle of order time may vary. also, there are specific standards established in any business to monitor the quality of order and check the average order time and keep it steady. order constraints are preset expectations or requirements that prevent flexibility in order processing and delivery. due to the order constraints, the cost of order processing and delivery can increase. the example of order constraints includes minimum order size, fixed days for receiving order, maintained specifications for order, etc. order constraints also help with the order planning as the restrictions are known ahead of time. according to the logistic planners, presetting the delivery schedule, order conditions, packaging, etc. help the business to impose a organized processing of order and improve the delivery to the customer on time in a great extent. presetting specifications also help low volume markets serve reliable and efficiently in a continuous manner. customer service is extremely important in the logistics world because of the highly synchronized and detailed planning and execution that is required when operating on a global scale. multiple factors are critical in delivering high levels of customer service and they include high rates of order fulfillment, speed and frequency of delivery, inventory visibility, on-time delivery, condition of product on delivery, and accurate documentation on po's and bill of ladings. it is a multi-faceted concept of gaining and maintaining differentiation in the market-place. the customer service must meet the needs of different customers. 'perfect order' should form the basis for measuring service performance and to develop new service standards. logistics management plays a vital role in enhancing the customer lifetime value by increasing customer satisfaction and enhanced customer retention. in any business, especially in the transportation business, good customer service is a top priority. this is because customer satisfaction helps the business survive and grow simultaneously. in any sort of logistics operation, providing good customer service for example, monitoring shipments periodically from the warehouse until destination and notifying customers if their orders are facing delay for any circumstances will elevate customer satisfaction. monitoring deliveries at every point and communicating with respective personnel in need and sending notifications to the customer to brief them regarding the issue and arranging adjustments increases the customer's loyalty and thus sets the business in a unique position compared to other competitors in the market. poor customer service will drive customers away from the brand. customers usually shares with others regarding product quality. if the product is good and they are satisfied by the customer care service, they recommend the brand to others but if they feel unsatisfied due to low quality or poor service, they tend to alert others, which negatively affects the reputation of the company or brand. a negative reputation could be very hard to erase and tends to degrade the share value of the company. the relationship between customer service and sales is symbiotic. after having a positive experience with a business, most of the customers are actually willing to refer that company to another person. a positive experience in customer service not only help retain customers, but also help with the acquisition of new customers. retained and loyal customers can help increase incremental growth of a business. when comparing, retaining customers costs to times less than the cost of acquiring new customers. it is obvious that low-quality customer service has tremendous side effects in any sort of business. additionally, a business could lose the loyalty of the valued customers and there are risks of losing the best employees because whenever companies have a customer service problem. the best employees are obliged to fill up the slack for other employees, so they search for better opportunities for their talents. an industry survey revealed many penalties of bad customer service and their significance on businesses. for instance, reduction of the business volume contributed to almost one-third of the entire customer service related failures. other penalties include called in manager/salesman, cut-off of all purchases with suppliers, significant number of items discontinued, deny of purchasing new items and refusal to invest in promotion. fig. . shows some significant customer service penalties noted from an industry survey. so how can businesses go about fixing bad customer service experiences? it is very critical that business identify the root causes of bad customer service and address them before it is too late. before doing anything, business need to be more informed about the situation and underlying causes. they can connect with the employees and customers involved to identify the problems. once root causes are identified, business need to focus on addressing them applying various methods including training employees, reviewing business practices and strategic partnership, involving high level leadership, fixing the system, and compensating customer losses. in short, there are several ways to fix a bad customer service situation but arguably the best way is to prevent them from happening altogether. make sure the businesses have the right customer support infrastructure and consistently improve their customer experiences. to look at the importance of customer service is through the costs associated with customer retention. logistics customer service plays a critical role in maintaining customer patronage and must be carefully set and consistently provided if customers are to remain loyal to their supplier. on the average it is approximately six times more expensive to develop a new customer than it is to keep a current customer. thus, from a financial point of view, resources invested in customer service activities provide a substantially higher return than resources invested in promotion and other customer development activities. it is not always clear how important logistics customer service is until we understand how logistics decision making would be enhanced if we knew more precisely how sales change with changes in logistics customer service levels. business sales are related to customer experience and customer satisfaction. the exact relationship between sales and customer service varies by industry and specific business. generally, when customer service is poor, sales decline. as services increase above the level offered by the competition, sales gain can be expected as superior customer service increases the retention of existing customers and attract new customers. when a firm's customer service level reaches this threshold (level offered by the competition), further service improvement relative to competition can show good sales stimulation. it is possible that service improvements can be carried too far, resulting in no substantial increase of sales. efficiency in customer service can result from the combined impact of improving the elements of customer service, which has a quantitative effect on sales for a company. this is referred to as the sales-service relationship. there are several theories that conclude that if price and quality are equal a company must offer customer service to approximately the same degree as their competitors in order to maintain competitive advantage in a given market. the service level offering that is offerd by the competition in a market is considered the threshold service level. this threshold service level assumes that a company cannot sustain themselves in any market it they do not offer a base level of customer service greater than or equal to their competitors. once a company has reached the threshold service level, any improvements above the threshold are expected to stimulate sales. these sales can come from new and unexplored markets or customers converted from other companies. this section discusses varios models that formulate the theoritical relationship between sales/revenues and services. usually, better service generates more sales. in some cases, salesÀservice relationship for a given product may deviate from the theoretical relationship. following methods for modeling the actual relationship could be used in those specific cases. the two-point method involves establishing two points on the diminishing return portion of the sales-service relationship through straight lines. the method is based on the notion that multiple data points to accurately define the salesÀservice curve would be expensive or unrealistic to obtain, and if data were available, it is not usually possible to describe the relationship with a great deal of accuracy. first, set logistics customer service at a high level for a particular product and observing the sales that can be achieved. then the level is reduced to a low level and sales are again noted. these limitations suggest that a careful selection of the situation to which it is to be applied must be made if reasonable results are to be obtained. fig. . shows how the two-point method is used to correlate sales-service relations by establishing two points and the area covered based on the relationship of product sales and logistic customer service offered. the impact on sales/revenues to a change in service level may be all that is needed to evaluate the effect on costs. the sales-service relationship over a wide range of service choices may be unnecessary and impractical. sales response is determined either by inducing a service level change and monitoring the change in sales. these experiments are easier to implement because the current service level serves as the before data point. before and after experiments of this type are subject to the same methodological problems as the two points method described earlier. one problem in measuring the sales response to service changes is controlling the business environment so that only the effect of the logistics customer service level is measured. one approach is to set up a laboratory simulation, or gaming situation, where the participants make their decisions within a controlled environment. this environment attempts to replicate the elements of demand uncertainty, competition, logistics strategy, and others that are relevant to the situation. game involves decisions about logistics activity levels and hence service levels. by monitoring the overall time period of game playing, extensive data is obtained to generate a sales-service curve. the artificiality of the gaming environment will always lead to questions about the relevance of the results to a particular firm or product situation. predictive value of the gaming process is established through validation procedures. one of the popular methods for gathering customer service information is surveying buyers or other people who influence purchases. mail questionnaires and personal interviews are frequently used because a large sample of information can be obtained at a relatively low cost. survey methods must be used with caution because biases can occur. the questions must be carefully designed so as not to lead the respondents or to bias their answers and yet capture the essence of service that the buyers find important. the finding of survey can be used to model the relationship between the cost and the customer service level. there is a cost associated with providing the logistics customer services. as the level of customer service goes up, the cost associated with providing that service also goes up. for example, a business has to spend more money to improve order fullfillment rate from % to %. the most critical question for a logistics manager is where they choose to be in relation to cost and customer service levels. as activity levels are increased to meet higher customer service levels, costs increase at an increasing rate. this is a general phenomenon observed in most economic activities as they are forced beyond their point of maximum efficiency. the diminishing returns in the sales-service relationship and the increasing cost-service curve results in a profit curve. the profit contribution curve results from the difference between revenue and costs at various service levels. because there is a point on the profit contribution curve where profit is maximized, it is this ideal service level that is sought in planning the logistics system. customer service level is defined by vrious factors such as percentage of ontime deliveries, percentage of correct orders, fulfillment rate, etc. optimum service level is a target service level where net profit is maximum while providing acceptable customer service. to maximize the net profit, it is imperative to maximize the revenue while minimize the cost at that particular service level fig. . . identifying the revenue and cost for each service level will provide the logistics professionals a starting point to make this critical decision. revenue, cycle time, shipment cost, handling costs, and inventory costs are some of the factors to determine the optimum service level. each level of service has an associated cost level. when activity levels are figure . relationship between revenue and logistics customer service. increased to meet higher customer service levels, costs increase at an increasing rate. profit contribution curve results from the difference between revenue and costs at various service levels. the maximum profit point occurs between the extremes of low and high service levels. net profit is the driving force for businesses that provide logistics services. the optimum service level is found when the net profit is maximized. net profit (np) is the difference between the revenue (r) and the costs (c) associated with all logistics services. the relationship can be expressed as np r c. for each level of customer service, a company can realize a specific revenue and cost. the difference between the revenue and cost varies along the service level. although net profit in a logistics business is essential, determining logistics decisions about transportation has many factors and one key factor is quality. a shipment arriving on time in the condition intended is a key factor in customer service. imagine you have ordered for your child a stereo for christmas over the internet. the package is supposed to arrive on december , at your home in plenty of time for wrapping and you are pleasantly pleased with the free shipping offered. the package leaves on time and you are tracking it to your home in anticipation. now it is christmas eve and you do not have your package and your unhappiness is growing with every moment. the package arrives on december , and looks like it was dropped from the truck on the way. in this situation, your transportation costs expectations were met but your expected service quality was not met. the mix of the two is the ideal spot for customer service and happiness. another factor in the overall customer service level is the amount of variability present in each service provided. "service variability is a characteristic that differentiates services from goods, and it can be defined as changes in performance from one service encounter to another with the same service provider" (mcquitty et al., ) . variability in any service implies additional risks and uncertainty. the larger the uncertainty in a supply chain the larger the costs for safety inventories, time in transit, or cost of expedited deliveries. in the case of customer service, variability is generally considered negative to overall customer experience. variability is a powerful term in the logistics customer service arena. the global economy has contributed greatly to the variability in customer service. instead of depending on a local supplier to deliver a component, companies now relies on suppliers from the other side of the planet. due to the global nature of supply chain, service variability is very high. for instance, ocean shipping causes variability due to various factors including shipping schedule changes, international rules and regulations, customs delay, navigation challanges, and port capacity. how much variability can be tolerated by a customer is the million dollar question? customer service in supply chain operations can be quantified by the percentage of products or services that meet delivery due dates, order filling accuracy, stock-out percentage, and several other service variables. genichi taguchi developed a loss function that is critical to managing the supply chain processes that determine customer service levels. "taguchi proposed that inconsistent quality in product and services results in expense, waste, loss of goodwill, and lost opportunity whenever the quality target value is not met exactly" (ballou, ) . service levels are viewed to be satisfactory and without any penalty cost as long as variations in service levels remain within the upper and lower limits of the accepted range. fig. . graphically represents this loss function. a loss function defines the potential loss of a business due to not fulfilling the target service level. for example, a service was expected or promised to deliver at a certain location, at a certain date and time, at a certain price, at a certain condition. if there is a deviation of service from the expected or promised targets, there is a potential loss for that service provider, taguchi's loss function determined that cost penalty (losses) occur at an increasing rate as the level of service deviates from the target value. the following formula is used to derive the loss function: l kðy mÞ where: l loss per unit ($) y value of variable m target service variable k constant representing the importance of service variable taguchi's loss function allows a value to be placed on not meeting the expected customer service levels within supply chains. in this way, companies are able to quantify the loss associated with poor customer service performance. additionally, this loss function formula can be utilized to optimize service levels by determining the appropriate amount on variability for service levels. example: target delivery time for an autoparts supplier is hours. parts delivered more than minutes late incur a penalty of $ off the total bill. delivery costs are estimated at $ but decline at the rate of $ . for each minute of deviation from target. how much variation should be allowed in the delivery service? step : find k l kðy mÞ kð Þ k $ : =per minute step : find varðyÞif m is taken as y : ð : Þ : minutes no more than . minutes should be allowed from the -hour delivery target to minimize cost. supply chain visibility in global outsourcing is the visualization of information related to product or service quality and makes it available to all actors in the supply chain network. actors in supply chain network include retailers, pl/ pl providers, manufacturers, sub contractors, suppliers, etc. as global outsourcing continues to become complicated, visibility of quality information is rapidly becoming the fundamental building block for outsourcing supply chain networks. information technology advances now make extended visibility across organizations possible. information visibility of orders, plans, supplies, quality specifications of supplies, inventory, and shipments is key to successfully coordinating events across the network and to monitoring analytics that track the health of the network and allow for proactive action. the greatest benefit comes from leveraging visibility information to identify and eliminate root causes of quality problems, and to rapidly respond to ensure the quality of outsourced products and services. this early identification and correction of quality problems in global outsourcing can help companies reduce the consequences of poor quality of products and services. customer service can be a constraint to a logistics system. service levels set by competitors and often traditional service levels can affect the customer service and cost relationship. sensitivity analysis can help aid a logistics operation to determine the factors that constrain the operation. the ideal solution is still the optimum balance between quality and cost; this should be weighed heavily in all analysis of the constraints. assuring quality in logistics operations such as global outsourcing is very challenging due to the multiple layers involved in the supply chain. supply chain layers include worldwide retailers who outsource products or services globally, intermediaries such as pl/ pl, freight forwarder, broker, overseas manufacturers and their sub contractors, and various levels of vendors. these layers are sometime loosely integrated and hence hard to maintain quality throughout the chain. some layers have quality assurance, but to truly ensure quality products and services, every member of supply chain layers should be considered quality assurance so that the work is done according to specifications. one could say that creates a culture of quality that is ingrain to every layer of the supply chain including an outsourced vendor. companies may actually decide that in order to meet their quality objectives, some services or products must be outsourced overseas to more skilled laborers. they feel that they do not have the skills in house, and quality is better met by outsourcing the necessary work. a test may be needed on a product and the company may not have the facilities, equipment or the skilled manpower to perform it and therefore they find a company that is more capable and has the facility to perform the test. by that decision, a needed operation is performed and the company's schedule is not interrupted if accurately planned. steps can be taken to help ensure the vendor provides services and products at quality levels that are acceptable to both internal and external customers. as stated before proper integration of the outsourced work into the supply chain is paramount. no work can properly be accomplished and managed with an integration plan to guide and oversee the vendor's work. if outsourcing is a strong option for the company, but yet there is a lack of trained workers, the company should provide training for the vendors to prepare them for the work that need to be accomplished. the company should also work on the cultural differences between them and the outsourced vendor. they should not seek just to completely change the vendor's way of accomplishing work, but they should strive to understand the vendor's cultural. this will assist in making decisions on how to define requirements to the group and how to help them meet the requirements. u.s. companies should understand that there are different ways at arriving to a solution as long as the requirements are met. in realizing the cultural differences, u.s. companies should make sure the vendor clearly understands what is expected of them. words that are used in the u.s. may have a totally different meaning to someone in india or china. the company may feel they clearly defined their requirements and the vendor may feel they clearly accomplished the work according the requirements as they read or understood them. only later, sometimes too late, they find out the product or service did not meet the requirements and the vendor did not clearly understand. a liaison from the parent company should network with a liaison from the vendor who has a clear understanding of the english diction. they will assist in knowing whether the company is effectively providing their requirements to the vendor and the vendor clearly understand what is needed of them. the company should also set up quality metrics that are understood by the vendor and should become a part of the vendor's way of business. in order for quality to become a complete part of the company's supply chain, the outsourced company has to make quality inherit to their business. the company should be able to provide back to the vendor what work is acceptable and what goals are not being met. they should also provide suggestions on how to achieve the required goal. incentives should be provided to the vendors who continuously provide quality products and product non-confirming vendors should be addressed appropriately, including termination of their services if they continue not to meet the expected quality level. most of the time, logistics operation run smoothly and as planned. there are times when disruptions cause havoc to logistics operations. the aftermath of any disaster could be enormous and annihilating for any logistics operations, especially for healthcare industry. in case of an emergency, the healthcare organizations in the affected region may experience out of stock situation for medical supplies which eventually impact their services. healthcare providers need to replenish their supplies from central distribution centers or unaffected regional distribution centers. the most difficult situation that authorities face is the complexity of operating conditions where they had to work in order to supply medical items to the affected region from a central position. some regions may be very difficult to reach under disaster condition. in this scenario it may be required to share medical items from contiguous health care organizations. product recall or system breakdowns also demand contingency plans. a global economy has inherently a very complex logistical system. getting a raw material from china to a us manufacturer and then the final product back to japan can have many factors that can cause a system breakdown. weather, a natural disaster, an economic upheaval, or even political changes can affect the supply chain in many drastic ways. for instance, covid- and its associated impacts paralyzed the health system deliveries in many places includinng in the u.s. many hospitals were out of ventilators and other personal protective equipment during this pandemic. inventory is the attribute of a supply chain or logistical system that will allow them to strive in one of these dramatic events. inventory will allow the system the time it needs to recover to prevent performance levels. product recalls are becoming more and more the norm of businesses today. the tremendous growth in returns has enthused new interest in reverse logistics (rl) as firms attempt to meet various challenges. typically, the higher the level of challenge greater is the opportunity for improvement. this is especially true in the case of rl management. engineering a rl network is fraught with daunting challenges due to the sheer uncertainty that surrounds returns quality, quantity and time. transporting returned goods is usually difficult and a cumbersome process. statistically, there are up to times the number of transactions involved in the returns process than to sell the product in the first place, and more require human intervention. for example, an outbound shipment of goods only involves one or two transactions (picking up the goods from a warehouse and delivering them to a small number of locations, or even just one location). however, the process of returning just ten items could mean supply from many locations, plus a different problem resolution per item, and at different times. rl may be an area where companies can gain a sizeable advantage over the competitors. in today's highly competitive economy, high-quality customer services are the tickets to the game. it behooves an organization to differentiate itself from its competitors. in this regard, rl could be one of the major differentiators that organizations can take into account. many companies in the world, including in the us, lack a methodology for designing an efficient reverse logistics that focuses on the industry's salient features: high "marginal value of time", high "value recovery" and high "volume" of returned goods. customer service is a very important measure of the efficiency of a logistical system. many measures and processes allow the logistics professional an opportunity to receive feedback from the customer on their efficiency. the adage that the customer is always right may not always be true but certainly reigns supreme in most companies. the complexity added by a global economy has increased the visibility of customer service in logistics and emphasizes the importance of measuring and examining the process. customer service will influence many decisions in logistics and require much analysis for optimum performance. business logistics/supply chain management (fifth ed) strategic nature of the logistics customer service in the supply chain customer service: thekey to customer satisfaction, customer loyalty, and marketshare service variability and its effect on consumer perceptions and intentions managing a customer-driven supply chain, inbound logistics logistica. editura uranus, bucureşti. importance of customer service in transportation operations key: cord- -poa w authors: zimmerman, brittney s.; seidman, danielle; berger, natalie; cascetta, krystal p.; nezolosky, michelle; trlica, kara; ryncarz, alisa; keeton, caitlin; moshier, erin; tiersten, amy title: patient perception of telehealth services for breast and gynecologic oncology care during the covid- pandemic: a single center survey-based study date: - - journal: j breast cancer doi: . /jbc. . .e sha: doc_id: cord_uid: poa w prior to the coronavirus disease (covid- ) pandemic, telehealth was rarely utilized for oncologic care in metropolitan areas. our large new york city based outpatient breast/gynecologic cancer clinic administered an -question survey to patients from march to june , to assess the perceptions of the utility of telehealth medicine. of the patients, ( %) completed the survey, and of the respondents, ( %) had participated in a telehealth visit. we evaluated the use of telehealth services using the validated service user technology acceptability questionnaire. sixty-eight patients ( %) reported that telehealth services saved them time, ( %) reported telehealth increased access to care, and ( %) reported telehealth improved their health. overall, ( %) of patients expressed satisfaction with the use of telehealth services for oncologic care during the covid- pandemic. telehealth services should be carefully adopted as an addition to in-person clinical care of patients with cancer. included minimizing in-person appointments to prevent the spread of covid- [ ] . although the current guidelines from the american society of clinical oncology provide that telemedicine should be utilized to expand service capabilities, telemedicine has, historically, rarely been utilized in providing oncologic care [ ] . a meta-analysis by chen et al. [ ] , studied the psychosocial outcomes of telehealth interventions on breast cancer patients; however, it did not evaluate patients' perceptions of the care they were receiving. a systematic review by cox et al. [ ] studied cancer survivors' experience with telehealth. however, none of the participants included in their review were actively receiving treatment. despite these shortcomings, both chen et al. and cox et al.' s findings [ , ] support the positive impact of telemedicine on patients. chen et al. [ ] found that telehealth interventions resulted in greater alleviation of stress and had a positive effect on patients' quality of life, perceived distress, and self-efficacy. cox et al. [ ] concluded that telemedicine had the potential to provide cancer survivors with a greater sense of independence. although the only studies that assess cancer patients' experiences with telemedicine are from programs that serve rural populations, these studies also paint an overwhelmingly positive reception of telemedicine. several studies from programs in rural areas including texas, tennessee, mississippi, arkansas, and newfoundland and labrador all reported high patient satisfaction from the majority of patients, as well as other benefits such as convenience and cost effectiveness [ , ] . it is likely that these individuals would have different experiences from those living in a metropolitan area during a global pandemic. cancer patients living through covid- may feel an increased sense of isolation and fear, and have less access to social support due to social distancing and quarantine [ ] . at our large nyc-based outpatient breast and gynecologic cancer clinic, telehealth services were quickly adopted for visits that could be completed outside of the clinic, in order to limit patient exposure to sars-cov- . these services consisted of video-based telehealth visits through the electronic medical system. these visits were typically to minutes in duration, with patient assessed vital signs (when indicated), limited physical exam based on visual inspection, and patient and provider-based discussion of the patient's oncologic care. these services replaced nonessential in-person visits but did not replace essential visits required for physical exams, laboratory checks, chemotherapy, or other treatment administration. any concerns that could not be addressed via telehealth required the scheduling of an in-person visit. this survey-based study aimed to assess patients' perceptions of the utility of telehealth in their oncologic care during a time of national crisis and its impact on various quality of life measures. an -question survey was administered to all patients receiving care at our outpatient breast and gynecologic cancer treatment center from march , to june , (appendix ). patients were included if they were seen in the clinic during that time, as well as if they had visits delayed or cancelled during this period. the survey was administered both by email through redcap and physical copies given at the clinic, wherein the survey was returned anonymously through a drop-box. all responses were de-identified and personal data was not available to the researchers. this study received approval from the mount sinai hospital institutional review board [irb] (irb- - ). the study was exempt from requiring the patient's completion of a consent form. consent was obtained by completion of the survey itself and the patient's review of the exemption form which was attached to the survey. survey responses were summarized by number (%) using sas version . (sas institute inc., cary, usa). no hypothesis testing was performed. for telehealth-specific questions, we adopted the validated service user technology acceptability questionnaire (sutaq) because the population it has been reliability tested for most closely fits the breast and gynecologic cancer patient population we serve-those with long-term health conditions or with social care needs [ , ] . the sutaq assesses patient acceptability of telehealth services via measures of accessibility, comfort, usability, privacy and security, confidentiality, satisfaction, convenience, and health benefits with in-home telemonitoring. for all survey questions using the sutaq scale, "agreement" was considered if the patient selected mildly, moderately, or strongly agreed on the -point scale (appendix ). of the patients who received the survey via redcap online or through a physical copy given at the clinic, ( %) completed the survey. of the patients who responded to the question about their diagnostic history, ( %) had a history of ductal carcinoma in situ (dcis)/atypical ductal hyperplasia (adh)/lobular carcinoma in situ (lcis), ( %) had a history of invasive breast cancer, ( %) had a gynecologic malignancy, and ( %) responded "other." of the patients who responded to the question on whether they had participated in a telehealth visit during the covid- pandemic, ( %) responded that they participated in a telehealth visit during the -month evaluation period. of the patients who participated in telehealth visits, ( %) felt that the telehealth services saved them time as they did not have to visit their oncology clinic as often. fifty-four ( %) felt that the telehealth services increased their access to care (health or social care professionals) and ( %) reported that the telehealth services helped improve their health. forty-five patients ( %) reported that telehealth services made them more actively involved in their own health, and ( %) felt that these services allowed the people looking after them to better monitor them and their condition. overall, ( %) patients were satisfied with the telehealth services they received, with ( . %) reporting that they "strongly agreed" that they were satisfied with the telehealth services (figure ) . of the respondents, ( %) would recommend these services to people with similar health conditions. twenty-seven ( %) felt that telehealth can be a replacement for their normal health care and ( %) reported it could be a good addition to their care. fifty-six ( %) would be interested in participating in telehealth visits in the future. figure . patient satisfaction with telehealth services. answer to the statement "i am satisfied with the telehealth services i received." overall, % of patients "strongly agreed" that they were satisfied with the telehealth services, % moderately agreed, % mildly agreed, % mildly disagreed, % moderately disagreed, and % strongly disagreed. very few patients reported concerns regarding the safety or confidentiality of the telehealth services. only ( %) patients felt that the telehealth services made them feel uncomfortable (physically or emotionally) and ( %) worried about confidentiality related to telehealth usage. however, ( %) patients felt that telehealth services were not as suitable as regular face-to-face consultations. additional responses to all telehealth survey questions can be found in table . the covid- pandemic led to major changes in the structure of oncologic care for the patients in our nyc center as we experienced the first peak of the pandemic from march through june . the adaptation of telehealth services was one of the greatest changes to our practice, with telehealth visits increasing from rare usage to accounting for about % of all visits. overall, patients with breast and gynecologic malignancies expressed satisfaction with the use of telehealth services for oncologic care during the covid- pandemic. although most patients do not feel that this is a suitable replacement for their in-person care, they expressed that it was certainly a good addition to their care. a large majority of patients expressed interest in continuing to participate in telehealth visits in the future. based on this data and prior studies, telehealth services should be carefully adopted as a long-term addition to the in-person clinical care of patients with cancer, including those being treated in metropolitan areas. there were several strengths to this study. first, the covid- pandemic provided a rare opportunity to assess the rapid implementation of telehealth on a large scale, which otherwise likely would not have occurred. secondly, it allowed us to receive rapid feedback regarding use of these services during an emergency public health situation. based on the results of our study, telehealth is an excellent option for care of breast and gynecologic patients during times when in-person visits may need to be limited. these results also support the use of telehealth services in metropolitan areas and in high-risk oncology patients-patient groups in which the perception of telehealth has rarely been explored. limitations of this study include that a large percentage of patients were undergoing routine follow-up for less active oncologic disorders such as dcis/adh/lcis. from this study, we cannot identify the percentage of patients who were receiving active chemotherapy or systemic therapy for metastatic disease. we also were not able to stratify patient perception of telehealth by disease type, as the survey was anonymous. we are unable to assess longterm outcomes in this study population as that would take many years of follow up. we acknowledge that there are inherent challenges in the incorporation of telehealth for care of cancer patients. these visits cannot replace in-person care, full assessment of vital signs, certain aspects of the physical exam (including breast exam) and chemotherapy, and other treatment administration which are specific to this population. the safety of telehealth services for breast and gynecologic cancer patients has not been specifically established, although major safety issues have not been reported in prior studies [ , ] . during the covid- pandemic, benefits of telehealth outweighed the risks, and it was widely adapted. this study reported subjective measures of patient satisfaction but did not evaluate objective measures of patient safety and cancer-related outcomes which will need to be established in future large-scale studies with prolonged follow-up. however, in this study reported here, patients did not report any specific safety-related concerns in the comments section of the survey. in conclusion, telehealth services can be utilized in addition to in-person care of patients with breast and gynecologic cancer in order to optimize patient satisfaction, save time and increase access to care, especially in times of public health crises. the findings of this study can likely be extrapolated to patients with other types of cancer in order to provide increased access to care for patients in metropolitan areas. https://ejbc.kr https://doi.org/ . /jbc. . .e telehealth services for oncology care during the covid- pandemic . the telehealth services have allowed me to be less concerned about my health and/or social care. . the telehealth services have made me more actively involved in my health. . the telehealth services make me worried about the confidentiality of the private information being exchanged through it. . the telehealth services allows the people looking after me to better monitor me and my condition. . i am satisfied with the telehealth services i received. . the telehealth services should be recommended to people in a similar condition to mine. . the telehealth services can be a replacement for my regular health or social care. . the telehealth services can certainly be a good addition to my regular health or social care. . the telehealth services are not as suitable as regular face to face consultations with the people looking after me. epidemiological and clinical characteristics of cases of novel coronavirus pneumonia in wuhan, china: a descriptive study the outbreak of covid- : an overview a novel coronavirus from patients with pneumonia in china a practical approach to the management of cancer patients during the novel coronavirus disease (covid- ) pandemic: an international collaborative group cancer patients in sars-cov- infection: a nationwide analysis in china full spectrum of cancer patients in sars-cov- infection still being described sars-cov- transmission in patients with cancer at a tertiary care hospital in wuhan, china a practical approach to the management of breast cancer in the covid- era and beyond resource for management options of breast cancer during covid- . rosemont: society of surgical oncology effect of telehealth intervention on breast cancer patients' quality of life and psychological outcomes: a meta-analysis cancer survivors' experience with telehealth: a systematic review and thematic synthesis evaluating the experience of rural individuals with prostate and breast cancer participating in research via telehealth extending oncology clinical services to rural areas of texas via teleoncology the service user technology acceptability questionnaire: psychometric evaluation of the norwegian version quantifying beliefs regarding telehealth: development of the whole systems demonstrator service user technology acceptability questionnaire the authors wish to acknowledge the support of the biostatistics shared resource facility funded by the national cancer institute cancer center support grant p ca - for analysis and interpretation of data and preparation of the manuscript. please complete the following survey in order to help your doctors understand the impact of covid- on the perception of your oncology care.by completing the survey, you will be providing consent for your data to be published. these survey results will in no way affect your future oncologic care.this survey is anonymous. thank you for your responses to this questionnaire, please check that you have answered all items. your responses will be kept confidential key: cord- -nl rhvlu authors: turner, cameron; bishay, hany; peng, bo; merifield, aaron title: the alpha project: an architecture for leveraging public health applications date: - - journal: int j med inform doi: . /j.ijmedinf. . . sha: doc_id: cord_uid: nl rhvlu objective: public health surveillance applications are central to the collection, analysis and dissemination of disease and health information. as these applications evolve and mature, it is evident that many of these applications must address similar requirements, such as policies, security and flexibility. it is important a software architecture is created to meet these requirements. methods: we outline the requirements for a public health surveillance application, and define a set of common components to address these requirements. these components are configured to produce services used in the development of public health applications. results: a layered software architecture, the alpha architecture, has been developed to support the development of public health applications. the architecture has been used to build eleven surveillance applications for the public health agency of canada in the areas of disease surveillance, survey, distributed data collection and inventory management. conclusions: we have found that a software architecture that addresses requirements on policies, security and flexibility facilitates the development of configurable public health applications. by creating this architecture, key success factors, such as reducing cost and time-to-market of applications, adapting to changing surveillance targets and increasing user efficiency are achieved. public health surveillance is the ongoing, systematic collection, analysis, interpretation and dissemination of data regarding a health-related event for use in public health action to reduce morbidity and mortality and to improve health [ ] . a public health surveillance application is a software system designed to assist in these activities. the ability to accurately monitor and track emerging and previously identified infectious diseases, such as severe acute respiratory syndrome (sars), avian flu, bovine spongiform encephalopathy (bse) and hiv/aids, is key to preventing outbreaks and epidemics. in the shrinking global village, an outbreak can quickly become a public health problem, so or no analysis and use of the corresponding information [ ] . there are many public health surveillance systems in operation. a review of current surveillance systems reveals that there are over detection systems in use in the u.s. and elsewhere [ ] . at the public health agency of canada (phac), there are different surveillance system applications in production, ranging from surveillance databases, survey applications, inventory and laboratory systems. many of these phac applications are customized to be disease-specific, or are developed for a particular surveillance function (e.g., subject identification encryption). furthermore, many of these phac applications are developed using different technologies. maintaining these heterogeneous systems are fiscally and resource expensive. rapidly changing environments require the delivery of timely surveillance information [ , ] . in response, the alpha project is an initiative that started in late . the purpose of the alpha project is to develop a software application architecture based on the philosophy of configuring and reusing common components to produce services that would be used to enable faster development of robust, maintainable public health applications. public health is practiced through complex relationships of organizations (e.g., local, federal) and functionally organized units (e.g., health departments, disease programs) [ ] . as such, the emphasis of the project is not on creating one monolithic application to handle all public health surveillance needs, but rather on creating customizable applications with the same underlying architectural or component structure. the goal is to reduce the amount of new development work required for each new application, in order to reduce its time-to-market. configuration plays an increasingly larger role in the development cycle, and leads to more flexible applications responsive to new and emerging public health needs. new components or services that have to be built are designed in such a way that other applications can use them, and contribute to the architecture. consequently, software becomes more maintainable, since applications share many of the same components. this paper defines a software architecture that is used to build public health surveillance applications. it focuses on common components, which are configured to provide different services that are integrated into each application. this paper is outlined as follows. in section , we summarize the requirements identified for a public health surveillance application. in section , the alpha architecture is described which meets these requirements. in section , three applications, which have been built using the alpha architecture, are explained. section provides a description of how the data collected within these applications is analyzed. related work is outlined in section while sections and summarize the paper. at the public health agency of canada, many different surveillance system applications have been developed using different technologies to collect data for specific diseases. by studying these applications, the following important, common requirements have been extracted: • flexibility: tracking and monitoring diseases is a dynamic activity. emerging diseases, such as sars can appear very quickly, requiring public health officials and surveillance applications to respond just as quickly [ ] . when a disease outbreak occurs, it is essential that the technology tools be in place to track cases and contact information. public health officials do not have the luxury of time to develop systems in response to each disease outbreak. an application must be flexible to handle new diseases [ ] . in addition, given the possible links between outbreak events, epidemiologists analyzing data collected by a surveillance system may need to gather different data as they discover new information. a surveillance application must be able to adapt to these changing data and analysis requirements. • maintainability: applications are inherently expensive to maintain. the cost of supporting a deployed software product can be between and % of its lifetime cost [ , ] . the greater the degree of heterogeneity that exists in the application suite available for an organization, the more expensive it is to maintain. for example, different applications tend to use different technologies and different versions of third party software. keeping track of all the applications' technology version matrices can be complex, and the licensing costs can be expensive. making viable the sharing of common architectural components among applications reduces support complexity and licensing costs. • jurisdictional configurability: each jurisdiction collecting public health surveillance data has its own policies or business rules governing the content and format of data to be collected. for instance, larger jurisdictions may be able to collect last names of their subjects, while smaller jurisdictions may only be allowed to collect their initials. similarly, some jurisdictions may want to include the complete date when collecting a birth date, while others can only record the month and the year. an application distributed to different jurisdictions must be able to handle these variations in policy. furthermore, since policies can change within jurisdictions, established or already implemented applications must be readily configurable. • alert notifications: a core requirement of a surveillance application is to send alert notifications to designated people indicating that a certain event has occurred. an event could be the occurrence of two or more cases of a similar disease being reported in potentially multiple jurisdictions within a certain time frame (i.e., outbreak). another event may raise attention to data anomalies within a case that requires attention. an event could even be a user accessing an application after hours. events such as these help users to manage their applications and understand the data being stored. alerts could take the form of an email notification, a message sent to a personal digital assistant (pda)/cell phone, or a posting to a web site. • security: due to the sensitive nature of public health surveillance data, security is of the utmost concern. one area of concern within security is authorization. particular individual users of applications may only see a subset of the data, and only certain functions of the application depending upon their role. for instance, if an application collects data from different jurisdictions, a public health official in one jurisdiction should not be able to see data collected in another jurisdiction. furthermore, access to different parts of the application should be restricted only to those who are authorized. auditing functions can also assist in monitoring what applications and which data are being accessed by a specific user. • usability: prior to the analysis and reporting of public health information, data must exist in a repository. currently, data collection poses the single most resource intensive component of surveillance cost, since data must be manually entered into a repository. a disease case can require the collection of, potentially, a few hundred data elements. based on our experiences, data entry clerks often complain of user interfaces being crowded with irrelevant data fields since not all data elements need to be collected for a case. to reduce this overhead associated with data collection, the presentation of a surveillance application interface must optimize data entry and filter out irrelevant data. • data sharing: public health surveillance applications collect data about different diseases from different demographics. this data is usually stored in different databases. valuable information could be discovered if field entries from these databases were cross-referenced, and in line with existing legislation and privacy controls stored in a central database. the pan-canadian electronic health record project by canada health infoway is a multi-year initiative focussed on integrating canadian surveillance systems from a data perspective [ ] . to support this important objective, a surveillance application must have the capability of sharing data with other applications. • statistical analysis and reporting tools: once data has been collected and entered into the system, epidemiologists and other public health professionals must be able to analyze the data and report on its contents. a number of commercial off-the-shelf (cots) statistical analysis and reporting tools adequately support this requirement. thus, phac has elected to integrate cots products into the surveillance environment to support this need. this section describes the alpha software architecture proposed to address the requirements previously identified. we have found that as different applications evolve and mature, a pattern of solutions has been discovered within the software that can be abstracted and reused to address these requirements. this bottom-up approach forms the core of the architecture's components. these components can be instantiated with concrete data and other code to produce a usable service. applications then use these services to provide the necessary functionality. fig. shows the alpha architecture. the component layer contains the building blocks that provide the framework for producing application functionality, but not the content. therefore, a component is not entirely usable on its own-it must be given a specific implementation. for instance, a profiler component provides an access control framework. the component, itself, is not concerned with the specifics as to what it is controlling access. the same is true with the business rules component. this component only provides the framework, language and inference engine to enable rules-based logic. it does not provide any actual rules. it is through the use of these common components that the maintainability requirement is addressed; these components form the core of the underlying structure of each application. the service layer provides a set of common services for use in the application and configuration layers. these services encapsulate a specific set of functions, which can be easily integrated into an application. these services are also used between themselves. for instance, a disease access service uses the profiler component to provide the access control functionality specifically for case information on different diseases. for this service, an instantiation of the profiler component with the addition of disease-specific data creates a service. the configuration layer provides a set of common tools that can be combined with applications in the application layer to deliver a fully functioning application suite. these tools handle certain configurations of the system. for instance, the business rules manager facilitates the creation, modification and deletion of business rules and policies. the access manager permits the configuration of the authorization privileges for organizations, regions and users. finally, the application manager allows for viewing and configuring logs and audits. these tools require very little modification to be adapted to be used in different applications. the application layer consists of the different applications comprising the entire system. applications, such as infectious disease surveillance system (idss), anti-microbial resistance surveillance system (amrss) and enhanced surveillance of canadian street youth (escsy) exist at this layer. these three examples are presented later. this section outlines the building blocks of the component layer, which provides the core of the architecture. public health is practiced through complex relationships of organizations (e.g., local, federal) and functionally organized units (e.g., health departments, disease programs) [ ] . as a direct consequence, public health applications must be flexible, secure and able to handle differences between jurisdictions. the profiler component is designed to meet these requirements. the profiler is a generic component customized to manage the authorization of an entity across different organizations. an entity is defined as anything that should be restricted at some level (e.g., a disease data element or an application function). the configuration of accessibility to these entities creates a profile. profiles are handled through the access manager in the configuration layer, and this tool is used to assign multiple profiles to a user. we model a profile using a hierarchical data model where the entity structure is based on categories, properties and attributes, and the organizations are based on groups and units within the organization. in our model, a category can have n properties. each of these properties can have n attributes. for instance, a disease (category) can have multiple sections to its data entry forms (properties) that, in turn, can have multiple data elements (attributes). similarly, an organization can have n regions (groups). each of these groups can have n districts (units), and each district can contain many users. fig. shows the data model for a profile. as an example, this data model provides an authorization service for diseases, and so it is possible to control access for every data element for each user. this addresses the security requirement as it prevents a user in one district from viewing or modifying public health data in another district. furthermore, we can also use this data model to provide an authorization service for application functions. access can be easily configured to accommodate some users in the same district from accessing certain functions within an application, while allowing another user in the same district to have full access. since the profiler component is a framework that is customized using data, new entities such as emerging diseases can be added or modified easily by inserting data specific to the new requirement, thus addressing the flexibility requirement. an application that can be adapted to handle the addition of emerging diseases solves one of the problems that hindered the fight against sars [ , ] . finally, the profiler component provides the ability to handle differences between jurisdictions. some jurisdictions may want to collect surveillance data that others may not need. the non-required data elements are then 'switched off', so they do not appear in the application. as a result, data collection is streamlined and application navigation is optimized at no additional cost to the development process. software systems are typically comprised of disparate applications, each executing in different process spaces. these applications can reside entirely on one machine, or be distributed over several machines. one of the requirements identified in the previous section outlines that there are times when applications need to share information. for this reason, a communications component is required to handle inter-application communication. the message server is designed to meet this requirement. messages are transmitted between applications over a secure http link using the simple object access protocol (soap). these messages are modeled using xml. we use a service locator to identify whether the service to be invoked should be done locally or remotely. for instance, a service to retrieve a patient's current active cases may be done within an application itself (i.e., locally). however, a service to retrieve a patient's case history may require sending a message to a central application, which, after authorizing the request, sends back the required information (i.e., remotely). the ability to configure where services are invoked gives flexibility to re-route messages based on current needs. once the decision has been made for a service to be invoked remotely, a message creator creates the xml message using the correct schema. this message is transmitted to the receiving application that uses a message parser to interpret the xml message, and a message handler routes it to the correct service. since soap is based on remote procedure calls (rpc), results are returned to the calling application. fig. shows the message server component framework. an agent is an autonomous entity that is assigned specific tasks to perform. these tasks, typically performed as a background process, can assist in addressing jurisdictional configurability and alert notification requirements through the use of business rules. therefore, an agent's duties involve the periodic collection of rules and data and applying these rules to the data. we model an agent using the observer design pattern [ ] . in this design pattern, there exists a :n relationship between a subject and its observers. when the state of the subject is changed in any way, the subject's observers are notified so they can take the correct course of action. in our agent model, the subject is a gatherer that retrieves information from a data source (e.g., surveillance data stored in a relational database). once the gatherer has retrieved the information it requires, the observers are notified of the event. the observers then retrieve the information from the gatherer, analyze it and take the appropriate course of action. a notification receiver is informed of the results. we have implemented the agent using a thread so that it can operate on a sleep-wakeup schedule. for example, an export agent wakes up at a predetermined time and retrieves information from an application's database instance. one observer is setup to export this data to a centralized repository, while another observer is setup to export this data to another application. fig. shows the agent component framework. the workflow component defines a set of tasks to be completed, and the order in which they should be completed. these tasks can be a set of screens to display, or a set of auto-mated work items to perform. one example of a workflow is an escalation scenario, whereby each task performs a higherdegree work item than its predecessor. the workflow component assists in addressing the jurisdictional configurability and usability requirements. workflows are configured based on the jurisdiction in which the application is deployed without affecting the underlying code. fig. -modeling a workflow using a graph. fig. -business rule to validate date of birth. also, data entry is facilitated as a user is guided through the entire process. we model a workflow as a graph, g = (v, e), where v represents the tasks and e represents the action required to move from one task to another. for any, t i , t j ∈ v, there exists (t i , t j ) ∈ e if t i is a task that must be completed before completing t j (i.e., t j depends on t i ). for example, assume three data entry screens exist, d i , d j , d k ∈ v. selecting a value from a data element's drop-down menu in the first screen, d i , may lead to the second data entry screen, d j , to get more information. in this case, (d i , d j ) ∈ e. after completing data entry on the second screen, d j , the user is next shown the third data entry screen, d k . therefore, (d j , d k ) ∈ e exists. if the value on the first data entry screen, d i , which leads to the second data entry screen, d j , was not chosen, the user is shown the third data entry screen, d k . therefore, (d i , d k ) ∈ e also exists. fig. shows this example's workflow. modeling a workflow using a graph allows us to conduct a depth-first search in order to determine all paths in the graph from one node to another. this assists in determining what data needs to be removed based on revisiting a previous node, and choosing an alternative course. we enforce certain rules, since workflow graphs can become quite complex. a workflow must have a single start node and a single end node. furthermore, while navigation can occur between a node and the node that preceded it, in order to avoid infinite loops an action cannot directly point to a preceding node. business rules are capable of monitoring data stored in a database or memory, and making intelligent decisions based on that data. since databases house large amounts of data in distributed tables, valuable information can reside undetected among these tables. information such as a user logging in at an abnormal time, or the frequency of a person visiting different clinics within a -h period, could be critical knowledge to some application users. therefore, monitoring and extracting information from data stores is of great importance. we model business rules using a rules-based expert system. expert systems encode the knowledge of domain experts in order to solve particular problems. in a rules-based expert system, these problems are solved using production rules. a production rule is stated in the form: p → q, which states if p then q, where p represents a set of premises, or conditions, and q represents a set of conclusions, or actions [ ] . the conditions can be linked together using boolean logic (i.e., and, or, not) and organized into sub-conditions using parentheses (i.e., order of operations). testing these production rules and firing, or executing, those rules whose conditions are satisfied, transform an initial state of knowledge into a new state of knowledge. problems can therefore be solved in a logical manner. the rules and the data upon which those rules act are stored in a knowledge base. the knowledge within the knowledge base can constantly change as data is added, modified or deleted when different rules are executed. furthermore, the rules can also be added, modified or deleted, without modifying the source code, in order to dynamically evaluate the rule set. this helps reduce code complexity, as increasing the amount of logic needed to handle many different scenarios can lead to difficult to read code, or spaghetti code. spaghetti code can be difficult to thoroughly test and debug [ ] . furthermore, hard-coding logic inevitably leads to multiple software configurations of the same application, which further complicates maintenance [ ] . therefore, part of a business rules system's power is not locking an application into a predetermined set of rules. due to the dynamic nature of the business rules component, the jurisdictional configurability and alert notification requirements are addressed. policies can be encoded as rules are deployed to different jurisdictions as seen fit. furthermore, alerts and notifications can be configured depending on the data to be monitored and the behaviour to detect. we use forward chaining for the business rules inferencing engine. forward chaining systems start with an initial state, where certain facts are known, and the rules are used to infer an end result, where the conclusions are initially unknown [ ] . for example, fig. shows a business rule to validate date of birth. this business rule evaluates a data element to ensure that the integrity of the information collected is intact. in this case, the business rule ensures that if the date of birth has been specified, it cannot be empty, it must be in the format yyyy/mm/dd, and it must be a valid date. such a policy would not be acceptable in a small jurisdiction where the collection of a subject's full birth date would violate legislation. the policy deployed in that jurisdiction would be changed to only accept four digits. in both cases, the underlying application code remains untouched. this section outlines case studies of three applications built using the alpha architecture. in the past two and a half years, we have built applications for the public health agency of canada using the alpha architecture. the three applications presented in this section were chosen since they show a wide range of services used. the infectious disease surveillance system is a web-based application that collects case information on tuberculosis (tb) and sexually transmitted diseases (stds) in canada's federal penitentiary system. this data is sent to correctional service canada (csc) for data entry and analysis. the following central services are found in idss. the disease access service is a service that controls users access to case information. the access to information is both at the presentation level (what the user can view), as well as at the data level (what the user can retrieve, update or report). the disease access service uses the profiler component to implement its service. users in different roles and different locations can only access data they are permitted to see. therefore, a user in one institution cannot view data about subjects in another institution. an administrator, when creating a user, controls the level of access to the disease case information. the administrator, for example, can restrict access to individual data elements on a form, a section of the form, or the entire form. therefore, it is possible for users to see tests that have been run on a particular subject, but not the test results. the jurisdictional policy service is a service that handles the different policies of jurisdictions. each jurisdiction may have different requirements for its data. for instance, in one jurisdiction only an initial can be stored for a first name, while no such policy exists in another jurisdiction. the jurisdictional policy service uses the business rules component to implement its service. rules are encoded into the business rules component, and when a user attempts to save data, these rules are tested for data violations. since these rules are not hard-coded into the application, rules are created, deleted or modified as seen fit. therefore, if one policy rule is not applicable in a jurisdiction, it can be deactivated or removed. the message routing service is a service that handles the communication between different applications. applications may need to share data with other applications, or get data from other data sources. therefore, a communications service is required. the message routing service uses the message server and business rules components to implement the service. this service extends the message server component by implementing an xml schema and parser to send generic retrieval and update requests. these requests allow the application to use local as well as remote databases as its data source. the anti-microbial resistance surveillance system is a distributed, data collection system designed to gather information into one central repository for reporting and analysis purposes. there are three separate locations, guelph, ontario; st. hyacinthe, quebec and winnipeg, manitoba that currently input their disease and biological data from animals, food and humans into their respective local databases. this data is then exported periodically (e.g., every min) into the central repository in ottawa, ontario. the creation of a central repository enables the assessment of event relatedness, detection of time trends and geographical patterns. furthermore, resources at the separate locations have the ability to analyze their own data, and also the capability to perform analysis on the integrated data. the data is simultaneously accessible by selected resources in different office locations, and within different departments. the following central services are found in amrss. the message routing service uses the agent, message server and business rules components to handle communication. this service defines an agent to periodically send messages containing disease and biological data collected from animal, food and human specimens from the local databases to the central repository. this service extends the message server component by implementing the necessary xml schemas and parsers. business rules are used to route these messages to the correct service. the alert and notification service is a service that handles raising events of interest to a designated person or persons. an event of interest could be an error condition, a policy violation, or some other event of which a person should be notified. the alert and notification service uses the business rules component to implement its service. rules are created to look for data transformation, data transfer or data integrity failures. for instance, if a record is not imported correctly into the central repository, the local administrator must be notified of this event. the local administrator must also be notified if a record does not contain the correct mandatory fields. if such errors are detected, an error report is created and sent via email to the local administrator. the administrator can then use the report to remedy the situation. the application function access service is a service that handles access control to various functions of an application. the privileges a user has dictates what that user can and cannot do within an application. the application function access service uses the profiler component to implement its service. the data managed within the component is organized into the applications (e.g., administration tool, data viewer), properties of these applications (e.g., user management, code management), and attributes of these properties (e.g., create user, delete user). a local administrator is permitted to create user accounts for those at their location; however, they are not permitted to change the values of the data element pick lists. the central administrator has access to all application functions. the escsy system is a web-based application that collects information on sexually transmitted diseases in street youth. data is collected from youth in their teens and early twenties by public health nurses who use paper-based surveys. these surveys are then sent to phac for data entry and analysis. the following central services are found in the escsy system. the survey service is the central service in the escsy application. it is responsible for loading questions, saving responses and assisting in navigating through the survey. the survey service uses the workflow component to implement its service. the workflow component permits this service to implement features such as branch/skip logic to bypass questions that are based on answers to previous question; conditional logic to control such things as genderspecific questions from being answered by the wrong gender; full navigation to go to the first and last questions, the previous question, the next question, as well as being able to specify a specific question and data integrity to prevent navigation to those questions that cannot be viewed. fig. shows an example of a question. as in the idss application, the jurisdictional policy service uses the business rules component to handle policies. the escsy application has certain security policies to enforce. one of the policies is user access expiry. survey data is entered using data entry clerks, typically students. in order to prevent access to those that have not logged onto the system in a certain timeframe, a policy is in place to prevent access to those not involved with the project anymore. this is a policy that is not required by our other survey applications that use permanent staff. fig. shows the two rules involved to implement this policy. the rule engine, operating in stand-alone mode, tests these rules every day. if the rule finds an expired user, the rules will deactivate that user and send an email to the administrator explaining the action taken. two other services used by these applications are outlined below. these services assist in the management of the application environment. logging and auditing are fundamental to all applications, since they record exceptions, errors and other events of interest. the logging and auditing service provides a level of security by monitoring, and capturing application and network access, messaging requests, failure events and system misuse. the logging and auditing service uses the agent component to implement its service. applications built using the alpha architecture write all their logs and audits to the file system. the logging and auditing agent periodically collects the messages stored in these files and stores them in a database. the application management service works with the logging and auditing service to provide application-level management. the application management service is based on the fcaps model (fault, configuration, accounting, performance and security) [ ] . the application management service uses the agent and business rules components to implement its service. the application management agent periodically analyzes the log messages stored in the database from the logging and auditing service to determine if policy violations have occurred. for instance, the application management agent can determine if a fault exception has occurred which needs immediate attention (e.g., an application has produced a critical fault), or that some other potential faults have occurred (e.g., warnings from an application within min). furthermore, the application management agent also determines if a security breach has occurred (e.g., an application has produced an audit trail of a user logging in after work hours to retrieve sensitive information). the applications we have developed using the alpha architecture provide surveillance officers and analysts the tools they need to do their jobs. preliminary analysis is done using the jurisdictional policy service to perform frequency analysis and correlation of variables relevant to that jurisdiction. for instance, in idss, business rules have been created to run a frequency analysis on variables such as tests completed or positive tests in order to generate a summary report on hiv/aids, hepatitis a/b/c and tuberculosis. monthly graphic or textual reports can include region, institution and disease form-specific information. more in-depth analysis and statistical reporting were deemed outside the scope of our work based on the number of readily available commercial applications. however, the surveillance officers and analysts are provided a data export service that extracts the information from their application into a text file based on their specific variables and formats. these text files are then imported into a tool such as sas (sas institute inc., cary, nc), and analyzed using various statistical analysis methods [ ] . results from data collected within the escsy application have been presented at a variety of forums [ ] [ ] [ ] [ ] . a number of surveillance systems currently exist, as well as a few initiatives to create an inter-operable network of coordinating systems. we discuss one of these surveillance systems and two of the initiatives under way. the real-time outbreak and disease surveillance (rods) system [ ] [ ] [ ] is a syndromic surveillance system developed in the rods laboratory at the university of pittsburgh. a syndromic surveillance system is designed to identify outbreaks based on reported symptoms that precede a diagnosis [ ] . in the rods system, data is collected from patients' chief complaints during emergency department visits, as well as patient registration at acute care clinics. after removing patient identifying information, the data is automatically sent to the rods system using a health level- (hl ) message. the rods hl listener parses this message and routes it to a bayesian text classifier, which assigns it to a syndromic category. the data is then stored in the database for other applications to use. this data can then be analyzed to detect disease and bioterrorism outbreaks. the rods system is deployed within several health systems in the united states. two of the initiatives to create a network of surveillance systems in order to enhance surveillance in a larger domain are the canada health infoway project, and the public health information network (phin) project at the centers for disease control (cdc). the canada health infoway blueprint [ ] is a government funded program to create a pan-canadian electronic health record system (ehrs). the conceptual architecture of the blueprint outlines how point-of-service applications (e.g., case management applications at clinics, and hospitals) send information using standardized messages (e.g., hl ) to a health information access layer (hial). the hial, which defines services that can be used by inter-operating networks, stores information it receives into the appropriate repositories and registries. the cdc is working on a framework to implement a standards-based network of inter-operable public health care systems [ ] . the phin functions and specifications [ ] outline components for those intranet and internet-based health systems that transmit data with their public health partners (e.g., laboratories, local public health agencies). these components are focused on detection and monitoring, data analysis, knowledge management, alerting and response. the canada health infoway blueprint and phin framework are primarily interested in building an inter-operable architecture for a cross-jurisdictional network, whereas the purpose of our work is to build an architecture for creating applications that would live in this network. both the canada health infoway blueprint and phin framework work on the principle that a secure, standards-based network of public health systems lead to better public health management and response. a key success factor for creating an architecture for public health applications is that the application must be useful to a surveillance officer. if surveillance officers cannot change the surveillance targets in a timely manner, they cannot meet their public health objectives. therefore, the architecture, in order to be successful, must be flexible enough to allow both existing and new applications the ability to adapt to new surveillance targets so that surveillance officers can collect and analyze their data efficiently. in the alpha architecture, the data elements and data types collected within idss were easily modified after the surveillance officer required different data elements. also, in another application, the canadian tuberculosis reporting system (ctbrs), we were able to adapt to a set of different disease data forms. in both cases, the changes were made through configuration without modifying the underlying code. another key to the success of an architecture for public health applications is that the applications should assist users to enter or retrieve data efficiently so they can spend less time on administrative tasks and more time on their primary work (e.g., health care professionals spend more clinical time with patients, surveillance officers and analysts spend more time analyzing data). in the alpha architecture, feedback from the surveillance analysts has indicated this objective has been met, since they now have the ability to configure access to specific disease elements. finally, one more key to the success of an architecture is that each application's software development cycle should be reduced as time goes on. consequently, there will be a drop in costs associated with each new application. in the alpha architecture, the escsy survey application took three developers months to design and develop. by the time the third survey application was built, it only took one developer month to configure the necessary survey, alert/notification and policy services. furthermore, idss took five developers months to design and develop, but a similar surveillance application, ctbrs, took one developer only months to configure the necessary disease access, alert/notification and policy services. once again, the increased reliance on application configuration rather than development allowed the alpha architecture to meet these goals. furthermore, the work we have done on the alpha architecture has provided us a lot of information on building public health applications. these lessons are being applied to extend our work in the future. the usability of an application provides one of the biggest sources of frustrations for our clients. we have addressed this issue using the profiler component and, more specifically, a service such as the disease access service in idss. this service only presents the necessary data elements to a user based on their role, privileges and interest. therefore, a data entry clerk does not have to sort through a screen full of irrelevant data elements in order to enter data into one or two fields. furthermore, most of the field surveillance officers enter data onto paper forms that data entry clerks enter into the system. we are currently investigating the feasibility of using personal digital assistants (pdas) that can be distributed to the field in order for the data to be entered once and synchronized with the application at the end of each day. this will help automate the data entry process. an issue still to be resolved is the privacy concerns of information stored and transferred using a pda. we continue to investigate the extension and addition of new components and services through analysis of our software as it is produced. for instance, we are currently expanding our data entry workflow service for a new project that involves directing the user to different screens (tasks) based on information they provide. this service, like the survey service in the escsy application, uses the workflow component. to assist in this activity, we are also developing a workflow manager tool that will reside in the configuration layer to automatically create, edit and evaluate workflows. our latest project, a prototype for a mobile clinic system, is designed to be used for special events. this system, which is a combination of the idss and amrss systems, link up distributed, mobile clinics to a centralized repository to present aggregate data. business rules are created dynamically to monitor for anomalies, such as a high frequency of symptoms from one particular clinic or from all clinics. although the applications we have implemented so far have been based on infectious diseases, they can easily be adapted to track chronic diseases and other conditions. integrated systems that monitor and track a wide range of public health concerns can lead to a better understanding of certain diseases [ ] . finally, we continue to monitor the activities and advances made by the canada health infoway and phin projects so that our applications can integrate with these networks using messaging standards and protocols such as hl . in this paper, we have described an architecture that can be used to build public health applications. the architecture is based on four layers: a component layer, a service layer, a configuration layer and an application layer. we have outlined the components that form the core of the architecture. we have presented as examples three applications built using the architecture and the common service elements. these services illustrate how the components were configured in order to produce the application products. updated guidelines for evaluating public health surveillance systems: recommendations from the guidelines working group renewal of public health in canada the sars commission interim report: sars and public health in ontario a national agenda for public health informatics; summarized recommendations from the amia spring congress an integrated approach to communicable disease surveillance how outbreaks of infectious disease are detected: a review of surveillance systems and outbreaks responding to the challenge of communicable disease in europe implementing a network for electronic surveillance reporting from public health reference laboratories: an international perspective public health information technology functions and specifications, version . . centers for disease control the sars commission interim report: sars and public health in ontario software maintenance costs software engineering design patterns elements of reusable object-oriented software artificial intelligence structures and strategies for complex problem solving toward a more reliable theory of software reliability telecommunication system engineering prevalence and correlates of chlamydia infection in canadian street youth hepatitis b in canadian street youth: trends in immunity between sti and hepatitis c in canadian street youth - : what are the rates in this population? in: poster presentation presented at the international society for sexually transmitted diseases research (isstdr) canadian street youth: sexual behaviours and self-perceived risk enhanced surveillance of canadian street youth: an overview technical description of rods: a real-time public health surveillance system fever detection from free-text clinical records for biosurveillance syndrome and outbreak detection using chief-complaint data-experience of the real-time outbreak and disease surveillance project framework for evaluating public health surveillance systems for early detection of outbreaks ehrs blueprint: an interoperable ehr framework ( . ), canada health infoway sars and its implications for u.s. public health policy: "we've been lucky this work is supported and funded by the centre for infectious disease, prevention and control (cidpc), public health agency of canada; information technology management section (itms), public health agency of canada and correctional service canada (csc). key: cord- - jquy authors: stewart, r.; martin, e.; bakolis, i.; broadbent, m.; byrne, n.; landau, s. title: comparison of mental health service activity before and shortly after uk social distancing responses to the covid- pandemic: february-march date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: jquy this study sought to provide an early description of mental health service activity before and after national implementation of social distancing for covid- . a time series analysis was carried out of daily service-level activity on data from a large mental healthcare provider in southeast london, from . . to . . , comparing activity before and after . . : i) inpatient admissions, discharges and numbers, ii) contact numbers and daily caseloads (liaison, home treatment teams, community mental health teams); iii) numbers of deaths for past and present patients. daily face-to-face contact numbers fell for liaison, home treatment and community services with incomplete compensatory rises in non-face-to-face contacts. daily caseloads fell for all services, apart from working age and child/adolescent community teams. inpatient numbers fell . % after th march, and daily numbers of deaths increased by . %. the first wave of the covid- pandemic had an impact across many healthcare sectors: not only because of the direct effects of the virus itself on communities and healthcare staff, but also arising from the national public health policies enacted to reduce spread. mental healthcare faced a range of challenges including the heightened vulnerability of its patient populations (e.g. through cardiovascular and respiratory disorders), already-reduced lifeexpectancies ( ), and frequently described problems accessing healthcare ( ; ). in addition, services had to be radically reconfigured to cope with suspected or confirmed infections in inpatient and outpatient settings, staff sickness or self-isolation, the need to minimise face-to-face contacts, and the need to accommodate increasing pressures on acute medical care from cases of viral pneumonia. these in turn were accompanied by the as yet unknown impacts of social distancing on already isolated or otherwise vulnerable populations, and of challenged national economies on already impoverished and disadvantaged communities. there therefore continues to be a pressing need for research ( ). taking advantage of a mental healthcare data platform that receives -hourly updates from its source electronic records, we sought to describe daily activity in key services for the months of february and march and to quantify statistically the early changes observed. register at the south london and maudsley nhs foundation trust (slam) has been described previously ( ; ). in summary, slam is one of europe's largest mental healthcare providers, serving a geographic catchment of four south london boroughs (croydon, lambeth, lewisham, southwark) with a population of around . million residents. slam has used a fully electronic health record (ehr) across all its services since , and the nihr brc case register was set up in , providing researcher access to de-identified data from slam's ehr via the clinical record interactive search (cris) platform and within a robust, patient-led security model and governance framework ( ). cris has been extensively developed over the last years with a range of external data linkages and natural language processing resources ( ). of relevance to the work presented here, cris is updated from slam's ehr every hours and thus provides relatively 'real-time' data, although prior to the covid- pandemic had mostly been used to support historic cohort analyses. slam's ehr is itself immediately updated every time an entry is made, which include date-stamped fields indicating patient contacts ('events') and those indicating acceptance of a referral, a discharge from a given service (or slam care more generally), including admissions to and discharges from inpatient care. mortality in the complete ehr (i.e. all slam patients with records, past or present) is ascertained weekly through automated checks of national health service (nhs) numbers (a unique identifier used in all uk health services) against a national spine. cris has supported over peer reviewed publications to date. cris has received approval as a data source for secondary analyses (oxford research ethics committee c, reference /sc/ ). activity and caseload data were extracted via cris and enumerated for every day from st february to st march . for inpatient care, the following were calculated: number of new admissions from the community, number of new discharges from inpatient care to the community, number of current inpatients. in addition, numbers of inpatients classified as on leave were calculated for illustration but not analysis. for other selected services, daily caseloads were calculated by ascertaining patients who were receiving active care from a given service on a given day, based on the date a referral to that service was recorded as accepted to the point a discharge was made from that service. daily contact numbers were ascertained from recorded 'events' (i.e. standard case note entries) for that service and were divided into the following groups according to structured compulsory meta-data fields for that event in the ehr: i) face-to-face contacts attended; ii) non-face-to-face contacts attended; iii) appointments cancelled or not attended ('dna'); iv) contacts listed as 'other'. non-face-to-face contacts included those recorded as being made by email, fax, mail, phone, online, or video link. this fourth group was investigated with manual inspection and was found to comprise a miscellaneous collection of contacts, including those with other staff members, other services (e.g. social care) or with patients' friends/family. the following slam services were chosen for description and comparison, on the basis that they represented the largest and most strategically important groupings: finally, mortality data (number of deaths for all patients with records) were extracted. caseload and contact data were extracted on nd april ; because of delays in registrations . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . and incorporation of this information coming in the case register, number of deaths were extracted for the time period of interest on rd april . the primary objective was to present descriptive data, which were displayed graphically (mon-sun for inpatient, liaison and htt services; mon-fri for cmht and camh services). in addition, caseloads and core activity (face-to-face and non-face-to-face contacts) were formally compared across the period of interest. in this respect, th march was chosen as an index date, being the date on which the national self-isolation strategy was announced (https://www.gov.uk/government/speeches/pm-statement-on-coronavirus- -march- ). activity levels before and after that date were therefore compared. because of the heterogeneity in levels of service delivery at weekends, statistical comparisons considered the weekday observations only (between the rd of february and the th march inclusive) for all measures. all variables represented counts of some type and were modelled using a negative binomial regression model to allow for overdispersion where this was indicated. to account for systematic trend over time, and also systematic weekly patterns the models included fixed effects of week ( levels) and weekday ( levels) factors. more complex modelling could not be supported by the relatively small sample size of observations to date. the negative binomial model assumed that the daily counts were statistically independent. time series data are often thought to display extra autocorrelations due to unaccounted shortterm effects. to account for these, a sensitivity analysis that fitted an autoregressive correlation structure (with one autocorrelation parameter) to the daily error terms within a week was carried out using generalised estimating equations (gee). observations from different weeks were still assumed independent. gee with a negative binomial distribution requires provision of the overdispersion parameter. this parameter was set to the value estimated in the negative binomial regression, provided the parameter had tested statistically . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . significant at the % level. however, many of these models fitted a negative autocorrelation parameter, which may indicate unaccounted systematic trend rather than error dependencies. either way, as will be described, inferential results were little affected by relaxing the independence assumption. daily counts for each service are graphically displayed in figures - , and comparisons before and after the th march are summarised in table table ). for all other services, there was a common pattern of reduced face-to-face and increased non-face-to-face contacts per day, although estimated trends in combined contact numbers were always negative (table ). liaison services (figures - ) exhibited a substantial (estimated %) fall in total contacts, and a small ( %) but statistically significant overall reduction in daily caseload (table ) . both working age and older adult htts showed reductions in total contacts ( % and % respectively) and daily caseloads ( % and % respectively), both more pronounced for the older adult services (table ) . considering community team services (figures - ) , all (working age, camh, older adult) showed reductions in total assessments ( %, % and % respectively), but only older adult daily caseloads fell (by %), while those for working age and camh services did not change significantly after the th march (table ) . daily numbers of deaths are displayed in figure and showed a significant % increase after th march (table ) . . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint we present findings from an early extract of data from a large multi-team provider on changes in mental health service provision before and in the initial stages of the covid- pandemic first wave in the uk, analysing these in relation to the enacting of a national social distancing policy. in summary, all grouped liaison, home treatment and community mental health services had substantially reduced face-to-face patient contacts, with variable and only partial compensatory increases in non-face-to-face contacts. many had also reduced their caseloads, although those for working age cmht and camh services remained level. numbers of patients in inpatient care had also been substantially reduced. daily numbers of deaths in past and present patients had increased significantly over a relatively short time period. at the outset, the potential impact of the covid- pandemic was widely discussed in a general sense, rightly focusing on the initial priorities of infection control, treatment options for severe complications, and the preparedness of critical care services ( ). however, a second wave of evidence gathering grew in importance, because of the potentially sizeable indirect consequences on other healthcare sectors. for mental healthcare, there continues to be a need to understand the population-level impact of both viral infection (severe or otherwise) and the social distancing being imposed by many national governments ( ; ; ). for people with pre-existing mental disorders, there has been a concern expressed that vulnerability to covid- infection may be higher than expected -because of infection susceptibility, comorbidity and barriers to health service access ( ). also discussed has been a potentially higher risk of mental health deterioration due to the stress of the pandemic itself, the stress of quarantine as a consequence ( ), and reduced access to routine outpatient visits . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint for evaluations and prescriptions, and there were concerns raised about a higher risk of suicide as a result of the rapid social, economic and health changes ( ). in addition, there may be higher rates of new presentations to services as a result of complex bereavements and post-traumatic stress disorder following severe hospitalised infections. some of these outcomes may still only become apparent after enough follow-up has been accrued for adequately powered analyses, by which time it may be too late for intervention. at the time the data were extracted for this report, the scale of mental healthcare changes had not yet been fully quantified, although recommendations had been made in china for tighter admission criteria and reduced hospital outpatient visits, amongst others ( ). while it was not our intention in this paper to investigate factors underlying the observed service changes, many will be unsurprising. clearly an inevitable outcome of social distancing, coupled with the rising awareness of staff risk from infections (and of the potential for staff-to-patient transmission), was a reduction in face-to-face clinical assessments. at the time of analyses, these had not been fully matched by increases in nonface-to-face assessments (for example, those carried out over the phone or via video calls) in all services evaluated. while it is possible that contacts labelled as 'other' might have included some direct assessments, numbers of contacts in this category were not markedly changed over the period of interest. the largest reductions after th march in total contacts were seen in liaison services, followed by htt services and then cmhts. on the other hand, reductions in median daily caseload were highest in older adult and working age htt services followed by small reductions in liaison and older adult cmht caseloads and no significant reductions in working age cmht and camh services. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . a rise in daily numbers of deaths after th march was also noted, although these findings were derived over a relatively short duration of surveillance. considering contemporaneous national reports for total mortality ( ), the % increase observed in the slam case register was of a similar order to the national % increase in care home residents, % increase in hospital inpatients and % increase in private home residents reported at the time ( ). strengths of this study included the relatively 'real time' data from a large mental healthcare provider, which allowed investigation of very early changes in service activity following dramatic and rapid transitions. clearly generalisability needs to be evaluated, as there may be a number of local and national factors that influence service transitions. london saw some of the earliest accelerations in covid- infections in the uk and there will have been pressures arising from local medical services (e.g. to free up mental health inpatient beds for 'overflow' from acute care) which are likely to have been felt by other london mental healthcare providers, but which may have occurred ahead of other areas of the uk. considering other limitations, data for this manuscript were drawn from specific services of interest and do not reflect slam's full activity; they were also combined by broad service categories and we did not seek to investigate within-service variation. daily contact numbers were quantified from structured fields applied to case note entries and might reflect recording behaviour rather than activity levels (e.g. if multiple contacts were recorded within one entry); also, the dichotomy between face-to-face and non-face-to-face contact is a relatively crude one and does not reflect the quality or depth of assessments being recorded. finally, statistical power was limited because of the short period evaluated, as well as being limited by lack of data on cause of death and applied to a heterogeneous sample of past and present service users. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . first author's note, in the interests of transparency: the findings reported in this paper were submitted in manuscripts to bmj open, bjpsych open, and bjpsych bulletin, with the first submission on st april after a data extraction on nd april (daily deaths data were updated in a subsequent extraction for later submissions). the findings were adjudicated to be insufficiently informative by the first two journals and the manuscript was rejected by the third because of difficulties obtaining reviews. by the time final feedback was received ( st july ), the study was judged by the authors to be too out of date for further attempts to seek peer-review. in the meantime, a number of approaches received from policy bodies for dissemination of findings reported here could not be accommodated because of results being under consideration for publication. the experience of attempting to follow the traditional academic publishing route in the context of rapidly changing circumstances requiring up-to-date data is a reason underlying recent dissemination of pandemic-relevant output from cris primarily via pre-print ( - ). the manuscript presented here has been amended from that originally submitted to remove statements of inference that might warrant peer-review. is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this this version posted september , . . college hospital nhs foundation trust. the views expressed are those of the author[s] and not necessarily those of the nihr or the department of health and social care. ( ) chang c-k, hayes rd, perera g, broadbent mtm, fernandes ac, lee we, et al. life expectancy at birth for people with serious mental illness, substance use disorders, and depressive disorders from a secondary mental health care case register in london, uk. plos one ; :e . ( . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this this version posted september , . . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . working age adult community mental health team contacts by contact type (daily caeloads per day figure : working age adult community mental health team active caseloads (daily caseloads per day figure : child and adolescent community mental health team caseloads (daily older adult community mental health team contacts by contact type (daily number of face-to-face contacts number of non-face-to-face contacts caseloads per day figure : older adult community mental health team caseloads (daily key: cord- - nf j authors: schwendicke, falk; krasowski, aleksander; gomez rossi, jesus; paris, sebastian; kuhlmey, adelheid; meyer-lückel, hendrik; krois, joachim title: dental service utilization in the very old: an insurance database analysis from northeast germany date: - - journal: clin oral investig doi: . /s - - -z sha: doc_id: cord_uid: nf j objectives: we assessed dental service utilization in very old germans. methods: a comprehensive sample of , very old (≥ years), insured at a large statutory insurer (allgemeine ortskrankenkasse nordost, active in the federal states berlin, brandenburg, mecklenburg-western pomerania), was followed over years ( – ). our outcome was the utilization of dental services, in total (any utilization) and in five subgroups: ( ) examinations and associated assessment or advice, ( ) restorations, ( ) surgery, ( ) prevention, ( ) outreach care. association of utilization with ( ) sex, ( ) age, ( ) region, ( ) social hardship status, ( ) icd- diagnoses, and ( ) german modified diagnosis-related groups (gm-drgs) was explored. results: the mean (sd) age of the sample was . ( . ) years. the utilization of any dental service was %; utilization was highest for examinations ( %), followed by prevention ( %), surgery ( %), restorations ( %), and outreach care ( %). utilization decreased with age for nearly all services except outreach care. service utilization was significantly higher in berlin and most cities compared with rural municipalities, and in individuals with common, less severe, and short-term conditions compared with life-threatening and long-term conditions. in multi-variable analysis, social hardship status (or: . ; % ci: . - . ), federal state (brandenburg . ; . – . ; mecklenburg-western pomerania: . ; . – . ), and age significantly affected utilization ( . ; . – . /year), together with a range of co-morbidities according to icd- and drg. conclusions: social, demographic, regional, and general health aspects were associated with the utilization of dental services in very old germans. policies to maintain access to services up to high age are needed. clinical significance: the utilization of dental services in the very old in northeast germany showed significant disparities within populations. policies to allow service utilization for sick, economically disadvantaged, rural and very old populations are required. these may include incentives for outreach servicing, treatment-fee increases for specific populations, or referral schemes between general medical practitioners and dentists. electronic supplementary material: the online version of this article ( . /s - - -z) contains supplementary material, which is available to authorized users. for decades, interventions to improve dental health have been focused on children and adolescents, with widely acknowledged success in many high-income countries. while adults and older individuals also benefitted from a general improvement in oral health, showing a reduced number of restored or missing teeth [ , ] , data on the resulting treatment needs in these populations are scarce. especially for the very old, defined as those aged years or older, there is very limited knowledge on their needs for and utilization of dental service. this group of very old, notably, is the only growing one in many high-income countries, with remarkably complex oral health dynamics: retaining an increasing number of teeth up to such high age, this group is, oftentimes suddenly, affected by general health deterioration, impacting on the capability for oral self-care as well as the physical abilities to utilize in-office dental care [ ] [ ] [ ] [ ] . in a previous study and building on claims data, we found a disparate utilization of prosthetic services in the very old, with those aged years or older, those living rural, and those with severe general health conditions utilizing prosthetic services, by large, to a lower degree than younger, urban living and only limitedly sick seniors [ ] . the only service the former group used more often was maintenance of existing prosthetics. notably, claims data come with a range of possible limitations, e.g., selection bias, confounding bias, or misclassification bias. however, employing claims data allows to investigate groups which are otherwise hard to represent, e.g., the very old, the sick, and the rural living ones. claims data also come with robust sample sizes and represent everyday care. they also suffer from limited risks of recollection or reporting bias and have a high generalizability for their respective healthcare setting [ , ] . in the present study, we used claims data from a large health insurance in northeast germany to assess dental service utilization in the very old. we hypothesized that utilization differed according to age, general health, socioeconomic status, and place of living. for reasons of comparability, the design and conduct of this study largely aligns with that of a previous publication on prosthetic treatment patterns in the same population [ ] . the investigated cohort was evaluated based on routinely collected claims data from a statutory (public) health insurance in germany. individuals aged years or older from one large insurer, the aok nordost, were followed over years ( to ). the aok nordost is a regional branch of the allgemeine ortskrankenkasse (aok), acting mainly in the northeast of germany in the federal states of berlin, brandenburg, and mecklenburg-western pomerania. our reporting follows the record statement [ ] . the aok nordost insures around . million individuals from the described three federal states. insured individuals may, however, also move into other areas of germany, which is why for our geographic analyses only individuals living in these federal states between and were included. the area of interest encompasses the german capital, berlin, and two rural states, brandenburg and mecklenburg-western pomerania, with only few larger cities (> , inhabitants). all three states are considered economically weak in comparison with other parts of germany. data for this study were claims data, including claims from january to december . data were routinely collected and provided under ethical approval in a pseudonymized form using a data protection cleared platform via the scientific institute of the aok nordost, the gewino. a comprehensive sample of very old, aged years or above, insured with the aok nordost in , was drawn and followed over years. no further eligibility criteria were defined. variable ascertainment was only possible via insurance base data and claims data. the database had been curated for plausibility at gewino and once more by the study team. no formal sample size estimation was performed given this being a comprehensive sample. our outcome was the relative utilization (in % of the population) of dental services. within the statutory german insurance, dental services are provided on a fee-per-item basis using fee items catalogs of the statutory or private german insurance [ , ] . the vast majority ( %) of patients are statutorily insured. for the statutory insurance, all items are drawn from the fee item catalog bewertungsmaßstab (bema), which contains a large range of granular items comprising ( ) examinations, assessment and advice, radiographic evaluations etc. (examinations); ( ) restorative dentistry (restorations), note that within german insurance coding, crowns are not subsumed under "restorations" and hence there is no overlap between this service group and our previous analysis on prosthetic dentistry; ( ) oral surgery and medicine (surgery); ( ) prevention (for adults, the only preventive measure available until was removal of calculus; in , further fee items (focusing on oral hygiene measurement, and oral hygiene plan, denture cleaning, and fluoride application) were introduced but these were not available for the present analysis); and ( ) outreach care. further items include, for example, periodontal treatment, prosthetic therapies, and adjunct measures. we here report on any utilization in bema (min item claimed/year) as well as stratified along the item blocks - . as this is the first detailed analysis on dental service utilization in the very old in northeast germany, we provide largely descriptive analyses. the utilization of dental services was assessed according to following independent variables: ( ) sex (male/female); ( ) age (in years) in each year of follow-up; ( ) region, we used municipalities as regional units, mainly as on a lower (more granular) spatial level only few individuals were retained in some areas. municipalities included the capital berlin (with over . million inhabitants), medium-sized cities ( , - , inhabitants), and rural areas. further analyses were performed on federal state level; ( ) social hardship status (income < euro/month per capita in ); ( ) icd- diagnoses, derived from outpatient diagnostic data; ( ) inpatient hospital diagnoses and treatments, derived from german modified diagnosis-related groups (gm-drgs). the gm-drgs classify diseases in groups of similar pathogenesis, characteristics, and treatment complexity, and are mainly used for reimbursement reasons. only the most frequently recorded icd- and gm-drg codes were used. the data used for this study were provided by the gewino using a data protection approved storage and analysis platform after cleaning and consistency controls. data were pseudonymized and included individuals' age, sex, social hardship status, spatial code of their place of living (allowing classification into municipalities), all bema items claimed per year as well as icd- codes and gm-drgs for each year, among further variables. comparability of data between different years and data consistency was given. a comprehensive sample had been used, and neither participants nor providers were aware that the collected claims data will be used for routine data analyses later on. the data collection is not prone to selection and detection bias. however, given this being claims data from only one insurance, the overall population of very old germans differs and data may be affected by biases associated with claims data, as laid out above and in the discussion. no further measures against these biases could be taken. the statistical analysis was performed on a sample (n = , ) of the database provided by aok nordost. the only inclusion criterion was that an individual had to be insured in the year and had to be aged years or above at this point. for the descriptive analysis of utilization of dental services, we considered an individual to have consumed a particular service if at least once during the period to the provision of such a service was claimed. descriptive statistics of age groups were computed based on the age distribution in . an individual was assigned to having a social hardship if the individual was assigned to this status at least once during the period to . for geographical analysis, we excluded all individuals that relocated from one of the federal states (berlin, brandenburg, and mecklenburg-western pomerania) to another federal state, thereby decreasing the sample size to , . however, we did not correct for relocations within the three federal states during the observational period. for each particular outpatient diagnosis (icd- codes) and inpatient hospital diagnosis and treatment (gm-drgs), we summed up all claims and ranked them from most to least frequent. we then selected the most frequent diagnoses each (in total ) and computed for each of them the number of individuals that were assigned to having a diagnosis, respectively, treatment, during to . we applied logistic regression, a method to model a binary outcome variable as a linear combination of predictor variables. the response variable was the utilization of any type of dental services claimed by an individual at least once in the year . as predictor variables we included age, sex, being deceased, social hardship status, federal state (note that we allowed the category "other" for relocated individuals), and the described outpatient and inpatient hospital diagnosis variables, all of them referring to the year . all analyses, modeling, and visualization were performed using python (version . , available at http://www.python.org) and auxiliary modules from its scientific computing ecosystem. overall, , very old ( years or older) individuals were followed over a period of up to years ( , of these did not survive follow-up). the mean (sd, median, min, max) age of the sample was . ( . , , , ) years. the population comprised significantly more females than males and those aged - years old than those aged years or older. about one-third lived in berlin, and the other two-thirds in the more rural brandenburg and mecklenburg-western pomerania. social hardship status was claimed by nearly half of the population at least once during the follow-up period (table ). our sample was overall more female and much older and claimed far more hardship status than the national average. the utilization of any dental service was %; utilization was highest for examinations ( %), followed by prevention ( %), surgery ( %), and restorative ( %) and outreach care ( %). utilization decreased with age for nearly all services except outreach care (fig. ) . utilization of restorations, surgery, and prevention decreased by - % (in relative terms, e.g., from % to % for restorations) between age and years; the decrease after age years was limited. a slightly less pronounced, but nevertheless consistent, decrease was found for examinations. in contrast, outreach care increased and was, at age years or above, the main service (together with examinations, which one would assume is the minimum consequence of outreach care). utilization was further different between regions ( table , fig. ). utilization of any dental service was generally higher in cities than rural areas, and highest in berlin and three other urban municipalities (rostock, potsdam, schwerin). utilization further differed geographically according to specific services. utilization of restorations was nearly % increased in certain cities and one rural southwestern municipality compared with most other rural areas. surgical services were provided more often in berlin and the south as well as cities in general; a similar pattern was observed for preventive services. for outreach care, no such strict pattern was observed; certain cities as well as a stretch of municipalities along the coastline showed higher utilization. utilization of any dental service was assessed according to icd- codes (table ) . utilization was higher for the majority of codes, e.g., for eye conditions (e.g., presbyopia, cataract, astigmatism), gonarthrosis, cox-arthrosis, benign hypertension, anti-coagulants therapy, varicose, prostate hyperplasia, osteoporosis, hyperlipidemia and hypercholesterinemia and unspecified chronic pain. a similar pattern was found for most specific services. notably, individuals with dementia showed a similar utilization with regard to any services, but mainly received examinations, not restorative or surgical care. the same was found for patients with urinary incontinence. for outreach care, an opposite pattern was observed, with higher utilization by those with dementia and incontinence, and lower utilization by those with eye conditions, for example ( table ) . we further assessed the utilization of any dental service stratified according to different gm-drgs (table ) . utilization of any service was higher in participants hospitalized for non-severe gastrointestinal ulcerations, non-severe arrhythmia, bronchitis, non-severe hypertension, syncope, non-severe renal insufficiency, and non-complicated cardial diagnostics or eye operations. utilization was lower in patients with severe gastrointestinal ulcerations as well as severe heart insufficiency. these trends of higher or lower utilization were similar for other services, except outreach care, where a different pattern emerged: utilization was higher in patients with non-severe but also severe ulcerations, paraplegia/tetraplegia, non-severe hypertension, infections, head or skin injuries, joint operations, apoplexy, and geriatric rehabilitation. it was lower in patients with bronchitis (table ) . in multi-variable analysis, social hardship status (or: . ; % ci: . - . ), federal state (brandenburg . ; . - . ; mecklenburg-western pomerania: . ; . - . ) and age significantly affected utilization ( . ; . - . /year), together with a range of co-morbidities according to icd- and gm-dgrs (table , table s ). pseudo-r indicated that the model generally had limited explanatory power (r = . ). understanding dental service utilization in specific populations and groups may allow to increase access to the right services for every individual, thereby improving health and services' efficiency and equitability [ ] . the present study tried to evaluate how factors driving services' needs (age, sex, general health) and access on patient level (income and financial means, place of living) and system level (physical and organizational) impact on utilization [ , ] . we hypothesized that the utilization of dental services in the very old was associated with an individual's age, general health status, place of living, and social status. moreover, we assumed to find service-specific disparities. we confirm these hypotheses; social, demographic, regional, and general health aspects were associated with the utilization of dental services in very old germans. a number of aspects should be discussed. first, utilization in this specific group was comparably high; in general, dental service utilization in germany is higher than that in most other countries, likely due to the setup of the service provision, with most services being available at no costs at all to the patient [ ]. moreover, regular consumption of dental services is incentivized using a bonus scheme, with patients getting a discount on their out-of-pocket expenses for prosthetic services in case they can demonstrate a history of regular yearly checkups. such incentive will be especially efficacious in old individuals, who either have or expect to have prosthetic services with higher likelihood than younger ones. we also found only minimal changes in the age-specific utilization over the -year period; that is, seniors of similar age did not show considerably increased utilizations in compared with , for example. the only detectable increase occurred between and , most likely associated with a general policy shift in dental healthcare in germany (an entry fee existing until , with patients paying euro to the practice-which passed it on to the insurer-whenever entering the practice for the first time in a quarter of a year had been abolished in ). these findings of rather constant utilization over the first half of the last decade as well as the increase in utilization of dental services from and are in line with previous research [ , ] . our findings are in so far relevant, as a number of major policy shifts targeting the very old requiring care assistance have been introduced between and , the effects of which our analysis did not capture (so far). this might be as we only included individuals aged years or older in and followed them for years (i.e., those entering this group later on were not included), but also as we did not focus on those requiring care assistance, i.e., probably "diluted" their relevance in our analysis. it would be relevant to re-assess this cohort, expanding it to individuals aged years or older in and focusing on only those receiving care assistance. we find a drastic and only limitedly service-specific decrease in utilization with age; individuals aged years, for example, consumed only a fraction of services compared with those age years. notably, from age years onwards utilization was fairly stable, indicating a possible "survivor" effect. the only exception from these observations was outreach care, as discussed below. age is associated with an increasing prevalence of chronic and severe diseases or hospitalization [ ] . in line with our previous analysis on prosthetic services, such severe general health conditions (e.g., severe gastrointestinal ulcerations as well as severe heart insufficiency) were found to significantly decrease utilization. notably, for most other (especially icd- coded) conditions, the overall utilization was unaffected. this might be as icd- codes were derived from ambulatory assessments, where individuals need to attend their general practitioners and hence show some kind of mobility and self-capability. moreover, individuals with dementia (and incontinency) showed reduced utilization of therapeutic services (but not examinations). this might be as these individuals do not accept more intense (and time consuming) care for treatment. we further assessed the impact of social hardship status on utilization. such status is a proxy for low income. it has been found associated with increased utilization of prosthetic services, as individuals with this status usually pay very low or no additional fee at all for any prosthetic service; that is, financial utilization barriers for this type of dental treatment are very low or absent [ ] . for the present analysis, hardship status was used only as a social marker, as the analyzed dental services (examination, restorations, surgery, prevention, outreach care) are coming at no costs for all statutorily insured individuals, regardless of their age. [ ] this is a remarkable difference of the german compared with many other healthcare systems, where retirement oftentimes means loss of professionally supported health insurance [ ] [ ] [ ] and a subsequent collapse of service utilization [ ] . it is noteworthy that utilization for those with hardship status was found significantly increased in multivariable analysis (in bivariate analyses this was less clear, indicating possible confounding by age, place of living, or health status, for example). as those with low social status are also likely to show the poorest oral and general health [ ], it is highly relevant to find them to consume services more often, too. it is beyond this study to elucidate the reasons underlying this utilization. notably, though, existing public policies to support healthcare utilization in vulnerable groups in germany, e.g., those with chronic diseases [ ] , do not capture those with economic constraints and poor oral health, i.e. cannot be at the heart of this association. independently of the found increased utilization, policy makers may want to revisit such policies and to strengthen dental service utilization for the very old, the very sick, and the very poor. we also found an association between utilization and place of living [ ] . such association has been assumed to be grounded in rural areas being underserviced due to workforce shortages while urban areas suffer from provider clustering and associated supply-side-induced demand [ , ] . we confirm such ruralurban disparities for any service utilization in the very old. the two rural federal states in our study, brandenburg and mecklenburg-western pomerania, show much lower dentist densities than berlin [ ] , possibly explaining our findings. notably, utilization in the whole population (not only the very old) has been found to follow the opposite pattern, with higher utilization in the two rural states than in berlin [ ] . hence, the observed inequalities seem to be moderated by age: older individuals seem to seek care more often, but are not able to physically access it in rural areas, while younger individuals could access it more easily in urban areas, but are not seeking care. we want to highlight that our analyses on smaller spatial level (municipalities) showed a more nuanced picture, with some rural areas showing high utilization of specific (but not all) services. we are so far unable to entangle possible reasons underlying this observation, which may be grounded in local dentist densities (some municipalities show surprisingly high densities) or a locally increased proportion of dentists with specific contractual agreements with care homes (thereby increasing access to care for the very old). more in-depth analyses seem warranted to first confirm and then explain such peculiar patterns, as they may allow to identify local best practices which could be translated to regional or national level. we identified service-specific utilization patterns not only across regions, as described, but also age. our findings of a generally decreasing utilization between age years and years have been identified before, with utilization of dental therapeutic services decreasing by around % along this age span in a national sample [ ] . in the national sample, restorative care was provided far more often than surgical care, while we found restorative care being consumed to a similar degree like surgical care. this might be as our sample was generally older and also represented a different target population (see below). we assume that these two factors drive a treatment concept where maintaining teeth (using restorative care) is deprioritized while achieving an overall pain free status (by removing teeth, for example) is getting more important (and usually also being the only available option). notably, prevention (which was only calculus removal in the present study) continued to be provided up to high age (albeit to a lower intensity). the only service where utilization was increasing with age was outreach care, while this seemed to allow for only very limited provision of therapies. it is relevant to understand the drivers behind treatment patterns in outreach care, and it may not be sufficient to only incentivize outreach visits, but also support outreach management or referral concepts for those requiring more complex care. in light of the covid- pandemic and the near-global shutdown of any dental visits (except for emergencies) to care homes (also in germany), outreach care is likely to be re-evaluated with regard to its benefits and risks. overall, our study calls for a range of possible policy and research initiatives: first, healthcare policy and decision makers should install incentives to provide services to the high needs elderly population. this may come by increasing single treatment fees for this group, or more generally by making outreach services more attractive. the latter may be realized by increasing fees once more or trialing and allowing different kinds of servicing, e.g., involving task delegation to assistance personnel. outreach care should further be provided not only to individuals in long-term care centers (nursing homes) but also to those residing at home (which is the vast majority of elderly). similarly, referral schemes between general medical practitioners and dentists may be helpful to identify high-risk individuals; mandatory follow-ups after such referrals may make sure that sick and remote older individuals (who seldom proactively seek care) are not plainly overlooked by standard dental healthcare. integrated service models (for example oral and dental hygiene enforcement for patients at risk for pneumonia) should further be strengthened. dental research, on the other hand, is called to action to develop applicable concepts fig. regionally specific utilization of dental services, stratified in services blocks, in northeast germany. relative (in %) any utilization and specific service utilization is shown. larger cities with an increased or decreased utilization compared with the surrounding municipalities are further highlighted by arrows table utilization of dental services according to international disease classification (icd- , german modification) codes by the very old in northeast germany. any and specific service utilization (in %) is shown icd- -gm *categories z -z are intended for cases in which facts are indicated as "diagnoses" or "problems" which cannot be classified as disease, injury or external cause under categories a -y **this chapter includes (subjective and objective) symptoms, abnormal results of clinical or other investigations, and inaccurately identified conditions for which there is no classifiable diagnosis elsewhere table utilization of dental services according to german modified diagnosis-related groups (gm-drgs encompassing effective management of dental diseases at optimal infection and transmission control measures. right now, servicing is at a minimal level due to fears of infection and it can be expected that infection control will remain a highly relevant topic in this vulnerable population even when covid- is finally brought behind us. moreover, dental research should develop and evaluate the described complex care models involving delegation or cooperation. a number of initiatives are currently underway in germany in this direction (e.g., https://innovationsfonds.g-ba.de). further, primary and secondary prevention models in this group should be enhanced; currently prevention concepts in the elderly are by large identical with those in younger individuals. policy makers may want to revisit such age-group-specific prevention concepts when they are available. generally, we see a great need to emphasize prevention in this group (based on our findings, prevention was near-absent for the very old in the northeast). dentists and dental bodies may want to actively participate in such research and also the implementation of possible policies, especially considering that with the very old, there is a growing group with high needs who can truly benefit from dental care. this study has a number of strengths and limitations. first, this is one of few longitudinal studies evaluating dental service utilization in very old individuals. our cohort involved over , individuals from three federal states spanning an area of similar size as austria or the netherlands and belgium combined. second, we evaluated a range of demographic, social, general health, and regional factors, some of which (drgs, icd- ) have not routinely been employed when evaluating dental healthcare. third, and as a limitation discussed above, claims data suffer from a range of biases. provided and claimed treatment cannot be equated with needs or morbidity. exploring causality is only limitedly possible, and within the present (largely descriptive) analyses, this was also not within our scope (the available longitudinal data may permit some more in-depth analyses in the future). any identified bivariate association may suffer from confounding bias, and even the performed multivariable analysis showed only limited explanatory value, likely as further relevant factors (e.g., medication, care status) were not available and accounted for, or as available factors (e.g., social hardship status, place of living) came with very limited granularity. fourth, individuals insured by aok nordost are not fully representative for other individuals from the same target area or even the whole of germany: more affluent people are often not statutorily insured (there is a minimum income level defined as entry barrier into private insurances in germany). this may affect the individual's health status and his or her utilization behavior (reflecting health literacy, but also specific incentives set by insurers towards seeking or avoiding care) as well as the number and type of services provided by the dentists (as services are remunerated differently). the northeast of germany is overproportionally old and, as mentioned, economically comparably weak (notably, there is a significant economic disparity within the northeast, too, which our data reflect on). the rural parts of the northeast suffered from emigration to other areas of germany especially after the reunification, while berlin experienced an over-proportional immigration in the s from aboard as well as the last years from within germany. these specifics will impact service utilization but may not be found to this degree in other areas of germany. future studies on the present dataset may explore them in detail, if possible, to better understand what impact on utilization they have. in conclusion, and within the limitations of this study, social, demographic, regional, and general health aspects were associated with the utilization of dental services in very old germans. we identified consistent and considerable disparities in utilization between populations. policies to allow service utilization also for the sick, economically disadvantaged, rural, and very old should be developed, tested, and employed. competing interests the authors declare that they have no competing interests. ethical approval and informed consent all experiments were carried out in accordance with relevant guidelines and regulations. data collection was ethically approved by the ethics committee of the aok nordost. no informed consent was required for this study given that data were pseudonymized. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creativecommons.org/licenses/by/ . /. global burden of severe tooth loss: a systematic review and meta-analysis trends in caries experience in the permanent dentition in germany - , and projection to : morbidity shifts in an aging society our current geriatric population: demographic and oral health care utilization ageing, dental caries and periodontal diseases elder's oral health crisis. the journal of evidence-based dental practice zahnverlust und prothetische versorgung prosthetic treatment patterns in the very old: an insurance database analysis from germany the limitations of using insurance data for research misclassification in administrative claims data: quantifying the impact on treatment effect estimates the reporting of studies conducted using observational routinely-collected health data (record) statement befundbezogene festzuschüsse als innovatives steuerungsinstrument in der zahnmedizin defining and targeting health care access barriers societal and individual determinants of medical care utilization in the united states barriers to and enablers of older adults' use of dental services can we predict usage of dental services? an analysis from germany dental visits among older u.s. adults, : the roles of dentition status and cost disparity in dental coverage among older adult populations: a comparative analysis across selected european countries and the usa dental care utilization and retirement oral health conditions of community-dwelling cognitively intact elderly persons with disabilities versorgungsprävalenzen bei Älteren senioren mit pflegebedarf bekanntmachung eines beschlusses des gemeinsamen bundesausschusses über eine Änderung der chroniker-richtlinie accessibility of general practitioners and selected specialist physicians by car and by public transport in a rural region of germany vertragszahnärztlichen versorgung von pflegebedürftigen und menschen mit behinderungen, kzbv/bzÄk zahnarztdichte in deutschland nach bundesländern im jahr der wirtschaft: trend zu festsitzenden versorgungen hält an acknowledgments we thank the gewino for providing access to the data within.author contributions the study was conceived by fs. fs, akr, and jk planned the analyses. fs, akr, and jk performed the analyses. all authors interpreted the data. fs wrote the manuscript. all authors read and approved the manuscript.funding open access funding enabled and organized by projekt deal. this study was funded by the bundesministerium für bildung und forschung (bmbf tailohr, az gy ).data availability data used in this study cannot be made available by the authors given data protection rules, but may be requested at the gewino. publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- -ffqewqdc authors: dhaggara, devendra; goswami, mohit; kumar, gopal title: impact of trust and privacy concerns on technology acceptance in healthcare: an indian perspective date: - - journal: int j med inform doi: . /j.ijmedinf. . sha: doc_id: cord_uid: ffqewqdc this paper augments the technology acceptance model (tam) by empirically investigating the influence of behavioral traits (privacy concerns and trust) and cognitive beliefs (perceived usefulness and perceived ease of use) on patients’ behavioral intention to accept technology in healthcare service delivery. despite increased emphasis on healthcare service delivery, there has been limited studies as to how various behavioral constructs are related to adoption of new technology in healthcare sector. to this end, and to develop meaningful insights, a conceptual model integrating behavioral constructs with constructs related to technology acceptance model is devised. the aim here is essentially to understand relationships that predict patients’ acceptance of technology in healthcare services. the devised model is tested on responses obtained from survey of patients availing healthcare service at various primary health centers in new delhi, india. structural equation modeling (sem) is employed to conceptualize the model and validate nine hypotheses entailing key constructs. the results indicate that perceived usefulness, perceived ease of use, trust and privacy concern are direct predictors of patients’ behavior to accept technology in availing healthcare services. in summary, this research provides an empirical contribution to the literature on effect of trust and privacy concerns on acceptance of technology in healthcare. in the declaration of alma ata in , governments across the globe pledged for health for all by the year , emphasizing improved access to primary health facilities and services by setting country specific healthcare targets. however, the targets were missed and considerable gaps in delivering and accessing healthcare services remain, particularly in developing countries (world health statics ) . great disparities in terms of measured health inequalities prominently and visibly persist across the developing countries (wagstaff, ) . poor in developing countries continue to have minimal access to health services, j o u r n a l p r e -p r o o f resulting in deterioration of health and thus, further aggravating poverty (smith, ; peters et al., ) . in order to access healthcare services, adoption of technology by patients has often been considered a key enabler for mitigating widespread disparities and poor accessibility (lalseng and andreassen, ) . in this backdrop, acceptance and utilization of technology in healthcare service delivery are crucial for both service providers and service consumers (patients). to address the question of adoption of new technology by the consumers, various models and theories have been developed in the past. some of the widely explored theories are theory of reasoned action (tra) (fishbein and ajzen, ) , theory of planned behaviour (tpb) (ajzen, ) , technology acceptance model (tam) (davis, ; davis, ) , innovation diffusion theory (idt) (rajagopal, ) , unified theory of acceptance and use of technology (utaut) (venkatesh et al. ) , technology readiness index (tri) (parasuraman, ; parasuraman and colby, ) . among these theories, tam is perhaps one of the widely explored models by information science (is) researchers (hwang ; venkatesh ) . it establishes parsimonious relationships amongst ease of use, usefulness, and intention to use. tam posits that usefulness and ease of use are the major determinants of the end-user's intention to use information technology (it) (davis ; davis ) . numerous studies have explored impact of technology (mainly it) on several aspects, such as quality, efficiency, and cost of healthcare services (chaudhry et al., ) . however, researchers have kept their focus primarily on design and implementation from the service provider's perspective. extant research literature is relatively limited in providing the understanding of the ways in which patients perceive technology usage and how technology is related to behavioral aspects (holden and karsh, ) . healthcare being expensive, complex and universally used service, is also one of the most personalized services. (berry and bendapudi, ) . building and maintaining trust and ensuring privacy are essential for continued participation of patients in a healthcare delivery system (mandl et al., ) . patients are often concerned about possible unwanted economic and social consequences resulting from misuse (or even abuse) of their health-related information (luck et al., ) . few studies have augmented original tam model to include the behavioural constructs particularly in context of healthcare delivery (rahimi et al., ) . studies have also focussed on qualitative exploration of challenges associated with technology adoption without taking pertinent quantitative analysis into account (pai and huang, ) . however, a detailed j o u r n a l p r e -p r o o f empirical study aimed at examination of nuances pertaining to technology adoption by patients in relation to privacy and trust in healthcare, particularly from a patient centric viewpoint (as opposed to service provider centric perspective) is a key contribution of our research. to this end, this empirical study focuses on patients receiving treatment in primary health centers (phcs) in new delhi, india is aimed at answering the following research in order to answer these questions, based on a comprehensive review of extant literature, we propose extending tam by integrating two latent behavioural variables, i.e., trust and privacy concern. this study puts forward a model apt for healthcare services in order to identify relationships between relevant factors affecting intention to use technology by patients. structural equation model (sem) is employed to analyse the structural relationships using survey based responses obtained from respondents belonging to the age group of to years, availing healthcare service at primary health centers in new delhi, india. we contribute to the extant research literature in three ways. first, we focus on acceptance of technology in healthcare from a patient centric perspective. second, we extend the tam framework with behavioural dimensions, aiming to explicate how these factors influence patients' perceived ease of use, perceived usefulness, and behavioural intention to use healthcare services. third, this study reaffirms theoretical foundation of tam in healthcare setup. rest of the paper is structured as follows. section gives details of the relevant literature related to tam and broad domain of healthcare. section illustrates research model and associated hypotheses. methodology is explained in section . data analysis and results are presented in section . section discusses the analysis and research implications associated with the study. limitation and future research directions associated with the study are presented in section . finally, concluding remarks are presented in section . the research gaps that we seek to address in this research are related to three key research streams namely, (a) it in healthcare and its adoption, (b) tam, and (c) privacy concerns and trust. now we present the relevant and recent literature for each of these three streams. information technology has transformed ways in which health information are obtained and utilized. based on respective health technology assessments, countries prioritize healthcare delivery in order to create sustainable health systems (littlejohns et al., ) . exclusively designed technologies for healthcare services have contributed to the digital health phenomenon (lupton, ) . researchers have studied impact of information technology on quality, efficiency and cost of healthcare services (chaudhry et al., ) . most of the studies show positive effect of it on healthcare services with some studies reporting mixed findings (buntin et al., ) . for example, positive outcomes such as reduced healthcare costs for both service providers and consumers were reported by li and benton, ( ) and increased service satisfaction by queenan et al., ( ) . devaraja et al. ( ) surveyed hospitals in us and substantiated using theory of swift even flow (tsef), the finding that adoption of it results in improved revenue. piccinini et al., ( ) reported reduced costs associated with management of healthcare due to centralization of healthcare service using it. lahiri and seidmann, ( ) reported reduced flexibility as an undesired outcome of technology adoption in healthcare service delivery. sharma et al. ( ) suggested complementarities between clinical health information technologies (primarily used for patient data collection, diagnosis and treatment) and augmented clinical health information technology (used for integrating information for augmented decision making) with respect to process quality. he et al., ( ) identified crucial features of medical sensor networks and introduced relevant node behaviors, including transmission rate and leaving time, etc., within the trust evaluation framework of healthcare delivery. emerging technologies such as big data, cloud computing, block chain and health sensing are revolutionizing healthcare operations and delivery (yang et al., , wan et al., and gan et al., . wang et al., ( ) enumerated a number of capabilities of big data analytics in healthcare sector, particularly for decision support capability, analytical capability for pattern of care, predictive capability, unstructured data analysis capability and traceability. zhong et al., ( ) proposed application of big data analytics for raising adoption of digitized health records. cloud computing as an enabler for cost effective j o u r n a l p r e -p r o o f solution for patient information, sensor-based health data collection and delivery has been proposed in many studies (binczewski et al., ; patra et al., ; rolim et al., ) . available literature on adoption of technology in healthcare can be broadly categorized in two streams. first, studies concerned with extent of it related adoption in healthcare by analyzing pervasiveness, scope and scale. second, studies examining enablers and barriers in adoption of it (agarwal et al., ) . studies belonging to first stream have explored various characteristics of healthcare service providers, such as size, location, competition, ownership status, etc., that have adopted it (cutler et al., ; jha et al., ; kazley and ozcan, ; mccullough, ) . major barriers in adoption of it as enumerated by second stream of studies include financial, functional, environmental and individuals including service providers and service users (bhattacharjee et al., ; desroches et al., ; jha et al., ; tang et al., ) . one key challenge with adoption of it in healthcare is that the systems are typically not designed for multi-institutional lifetime records. ethically managing health data, guarantee of security, auditability of records, and interoperability and immutability are few concerns that need to be addressed (ekblaw et al., ) . qadri et al., ( ) in their study of emerging technologies for healthcare delivery advocated for iot (internet of things) and ai (artificial intelligence) oriented healthcare delivery system. further, this study conceptualized the tenets of h-iot (healthcare internet of things). the arguments for adoption of h-iot was also supported by porambage et al., ( ) . meng et al., ( ) in their surveyed stakeholders belonging to different healthcare organizations developed a trust-based approach to figure out malicious devices in a healthcare environment. yan et al., ( ) proposed trust based framework for virtualized networks and softwaredefined networking. the study in particular argued for adoption of cloud computing to securely deploy various trustworthy security services over the virtualized networks. ahmed et al., ( ) explored the recent advances in big data analytics for iot systems as well as the key requirements for managing big data and for enabling analytics in an iot environment. lin et al., ( ) presented a blockchain-based system for secure mutual authentication to enforce fine-grained access control polices. proposed two trust evaluation algorithms to support different application cases. specifically, these algorithms can overcome attacks raised by internal malicious evidence providers. perera et al., ( ) argued for adoption of fog (edge) computing based approach for solving analytical and computational problems for diverse problems including those related to medical industry and smart cities. wazid et al., ( ) devised a novel authentication framework for medicine j o u r n a l p r e -p r o o f anticounterfeiting system considering the iot environment aimed at ascertaining the authenticity of pharmaceutical products. the key benefit of the proposed scheme was in terms of its lower communication and computation cost over other similar authentication schemes. wazid et al. ( ) proposed a new secure remote user authentication scheme for implantable medical devices communication environment to overcome security and privacy issues associated with existing schemes. there has been effective evolution and acceptance of technology globally since second half of th century. this has resulted in improvements in social lives, interpersonal relationships and even self-expression (gucin and berk, ) . tam, as a research stream, is a widely deployed model for accessing acceptance of technology in information systems because of its simplicity and understandability (king and he, ) . its proponents articulated that the key to enhancing use was to first increase acceptance of it, which could be assessed by measuring individuals' future intentions to use (davis, ; davis, ; davis et al., ) . the model is based on the theory of reasoned action (tra) (fishbein and ajzen, ) , a psychological approach that illustrates how individual's belief system mediates human behavior. tra theorizes that behavioral intention (bi) of an individual to use a product or a system is decided by the individual's attitude and subjective norms related to the behavior. tra assumes behavioral intention to be closely linked to actual behavior. in comparison to tra that explains many divergent human tendencies, tam focuses on a particular kind of behavior, i.e., the rational acceptance of technology by the technology user (davis, ) . tam involves two primary concepts namely perceived ease of use (peou) and perceived usefulness (pu) to influence dependent variable behavioral intentions (bi) (king and he, ) . pu and peou are defined in the following way: perceived usefulness (pu)-"the degree to which a person believes that using a particular system would enhance his or her job performance" (davis, , p. ) . perceived ease of use (peou) -"the degree to which a person believes that using a particular system would be free of effort" (davis, , p. ) . tam has been studied in different contexts with different technologies (e-mail, world wide web, hospital information systems, etc.). it has been applied with different control factors such as organizational size, type, gender, etc., on different subjects such as undergraduate j o u r n a l p r e -p r o o f students, mbas, and knowledge workers resulting in establishment of robustness among its proponents. tam has received enormous empirical support in elucidation and prediction of technology acceptance and use in various settings (dabholkar, ; dabholkar and bagozzi, , and . divergent external factors such as training, compatibility, anxiety, computing support, experience, relevance, personal innovativeness, etc., have been studied in context of tam (lee et al., ) . tam has also been applied to study various aspects in healthcare services. online disability evaluation systems, personal digital assistant for healthcare, telemedicine technology, electronic health records (ehr) and mobile applications are few of them. adoption of e-health monitoring using smart wearable healthcare devices has been one of the recent contributions to extant research literature (li et. al, ; papa et. al, ; wu et. al, ; zhou et al., ) . rahimi et al. ( ) employing a systematic literature review approach identified three ict application areas namely, telemedicine, electronic health records, and mobile application for tam in healthcare service delivery. the literature review also reported of a few studies wherein mediating role of behavioural aspects in conjunction with other factors such as mobile health, etc., were investigated. with ever increasing competition and growing personalization of markets, service providers are increasingly focusing on understanding the consumers (patients) better, thus leading to proliferation of consumer information. although, most consumers welcome the increased convenience and personalization as natural outcomes, many remain concerned about privacy associated with their personal information (lanier and saini, ) . privacy concern has been typically defined as concern for loss of privacy and need for protection against uncalled-for communication and misuse of personal information (smith et al., ) . it concerns with being in control of personal information exchanges and security, and whether the beholder of the information will use it appropriately (lanier and saini, ) . xu et al. ( ) suggested that privacy concern is the result of individual's outlook to privacy and circumstantial cues that enable him/her to assess the outcome of information disclosure. dinev and hart ( ) argued that perception of privacy develops socially through transactions with social entities. cognitive processes of identifying information boundary comprising of privacy risk, privacy intrusion and privacy control is vital for structuring the privacy concerns of an individual. the demographic factors such as age, gender, income status affect privacy concerns of consumers (culnan and armstrong, ) . individuals are found more concerned about their j o u r n a l p r e -p r o o f privacy when information is used without their knowledge or permission or when intended use of the information is not revealed (phelps et al. ) . these attributions have also been concluded and validated empirically in various models (phelps et al. , chellappa and sin ; dinev and hart ) . for some, protection of patients' information is part of core professional ethics and for others, it is simply occupational work in the interest of organization (anthony and stablein, ) . research on addressing privacy concerns of consumers has grown considerably in the recent past and shifted from general contexts to specific ones (yun et al., ) . researchers have explored privacy concerns in diverse fields like social networking (heravi et al., ; jeong and kim, ; lankton et al., ) , online services hart, , jiang et al., ) , healthcare (bansal et al., ; xu, ) , location-based services (xu et al., ; zhou, ) . studies have explored a large number of antecedents of privacy concerns. li ( ) categorized these antecedents into five groups on the basis of their level of study. these are individual factors, socio-relational factors, macro-environmental factors, organizational and task environment factors, and information contingencies. studies have conceptualized various instruments and models for privacy concerns in different contexts. for example, the concern for information privacy (cfip) (smith et al. ) conceptualizes organizational privacy practices. internet users information privacy concerns (iuipc) (malhotra et al. ) operationalizes multidimensional notion of internet users' privacy. however, for our study in healthcare services, we use model suggested by xu et al. ( ) . this model explains molding of individual's privacy concern towards specific practices through a cognitive process comprising of privacy control, privacy intrusion and perceived privacy risk. drawing on information boundary theory, this integrative model implies that the individual's disposition to situational or privacy indications thus enabling them to assess consequences of their information disclosures shape the privacy concern of the individual. trust, on the other hand, has received a great deal of attention in sociology, social psychology, economics and as well as in marketing field. it is an elusive multiplex concept (castaldo et al. ) and a multi-dimensional construct with two inter-related components, i.e., trusting beliefs and trusting intentions (mcknight et al., ) . rousseau et al., ( ) defined trust as "a psychological state comprising of the intention to accept vulnerability based upon positive expectations of the intentions or behavior of another under conditions of risk and interdependence". trust is essentially needed in uncertain situations, since it j o u r n a l p r e -p r o o f eventually implies accompanying risks and becoming susceptible to trusted parties (hosmer, ) . it has been identified as a catalyst of transactions providing service receivers with expectations of fruitful exchange relationship with service providers. drawing on various literatures, doney and cannon ( ) defined trust as perceived credibility and benevolence of a target trust. here credibility refers to the extent to which the receiver believes that the service provider has the required expertise to perform the job effectively and reliably. whereas, benevolence refers to extent to which the receiver believes that the service provider has the intentions and motives beneficial for the receiver in unforeseen conditions for which commitment is not made (ganeshan, ) . schoorman et al., ( ) contended that all three factors related to integrity, ability, and benevolence could affect trust in a group or organization. consumers' loyalty, long term relationships, commitment and product acceptance are underpinned by their trust in service providers (bozic, ) . trust plays a crucial role in virtually all shared economy interactions (hwlitschek et al., ) . in online domain, it often functions as the sole foundation for the consumers to take purchase decisions in case of scarce information (bleier and eisenbeiss, ) . gefen et al., ( ) called for reexamination of dimensionality of trust in context of online environments. they argued that besides existing methods like case studies, field interviews, surveys, econometric analysis, experiments, analytical modeling etc., for examining trust, other techniques like cognitive neuroscience too can be deployed for better understanding of nature, antecedents and consequences. söllner et al., ( ) reasoned that survey-based approaches postulate valuable insights about the interrelations of diverse trust concepts in is literature. these are frequently applied to distinguish between targets of trust that determine is use. in order to study technology acceptance in healthcare with respect to trust, we need to appreciate distinctions of healthcare services from other services. people commonly demand healthcare services under distress in that either they are sick or at risk thus relinquishing privacy. there is risk of loss of privacy associated with providing personal information (culnan and armstrong, ) . if the service provider cannot be trusted, there is no reason why consumers should expect to gain from using the particular service (paulov, ) . number of public opinion polls establish that individuals are quite concerned about threats to their personal information (xu et al., ) . however, partial mediation of trust and privacy concern reduce the perception of risk (andrews et al., ) . once consumers trust the j o u r n a l p r e -p r o o f service provider, the service provider seeks more health-related information (miller and bell, ) . bansal et al., ( ) established that personal disposition indirectly impacts trust through information sensitivity and privacy concern. platt et al. ( ) found that expectations of benefits and positive views of health information sharing are associated with system trust. steininger et al., ( ) in their study pertaining to acceptance of electronic health record (ehr) demonstrated that privacy concerns impact perceived usefulness of ehrs negatively. he et al., ( ) identified the security challenges facing a sensor network for wireless medical monitoring and suggested that the network should follow a two-tier architecture. based on such an architecture, the study also devised an attack-resistant and lightweight trust management scheme termed as retrust. zhou et al., ( ) likewise, researchers have extensively explored behavioural constructs namely, trust and privacy concern, their enablers and their influence on technology acceptance independently in online transactions and e-commerce applications. however, studies on effect of behavioural aspects of patients on acceptance of it in healthcare are lacking. because of various distinct characteristics of healthcare service, it would be fruitless to apply canonical approaches for assessing users' response by espousing inferences from studies carried out in other service setups. in this section, we present research model that encompasses elements affecting behavioral intentions of healthcare service users to adopt technology. researchers have widely explored it in healthcare from the perspective of associated merits and limitations within the sector. extant studies, primarily, have focused on enablers and barriers in implementation of it in healthcare sector from service provider's perspective (agarwal et al., ; dey et al. ; mccullough et al. ) . we find limited studies on adoption of technology concerning patients' perspectives. in this study, we extend tam from patient centric perspective by incorporating variables such as patients' cognitive belief, trust and privacy concerns in addition to tam variables. to this end, following hypotheses are conceptualized. perceived usefulness is the degree to which the consumer perceives a service useful, while perceived ease of use is the consumers' perception about effortless use of the service system (davis, ) . consumers evaluate usefulness of a service based on what they get and what they pay for it. similar to other services, within healthcare services as well, the patient strives for timely and right treatment without much burden on his/her resources. if the patient perceives that any technology can help in getting effective treatment, the patient is more likely to avail the service facilitated by that technology. similarly, given major parameters remaining same, if patients are provided with option to get themselves treated at any place without physically carrying their case history and using technology as facilitator, they would most likely gravitate towards accepting the technology. further, ease of use is vital for acceptance, as familiarity with technology and skills to use technology are likely to vary significantly within the diverse population. there is extensive literature that has established that perceived usefulness and perceived ease of use directly and positively influence behavioral intention to use. perceived ease of use also influences indirectly through perceived usefulness (dabholkar, ; dabholkar and bagozzi, ; davis, ; szajna, ; venkatesh, ) . therefore, in line with these arguments and extant literature, we hypothesize the following. in e-commerce and is literature, trust has been widely acknowledged in influencing user behavior in adoption of technologies (amoako-gyampah and salam, ; ha and stoel, ; paulov, ) . healthcare delivery, however, is more personalized and vital service for consumers (berry and bendapudi, ) . the patient has to give access to personal information and previous health records to the service providers. extant studies have established an array of divergent aspects in delivery and patients' ability to evaluate healthcare services (mcglynn et al., ) . healthcare is one such typical service, wherein efficacy of primary service availed (treatment) cannot be evaluated or verified even after consumption of service. hence, the consumer has to solely rely on the diagnosis made by the j o u r n a l p r e -p r o o f service provider. handing over personal details to the service provider is predicated upon trust, a vital factor in acceptance of technology in healthcare services. trust is one of the defining factors in such exchanges, where uncertainty is present. practically, trust is a prerequisite for interactions conducted in uncertain environment (ba and paulov, ) . in such situations, beliefs about the service provider (apart from usefulness and ease of use) also becomes crucial. if the service providers fail to convey trustworthiness, the consumer is not likely to engage in transaction (hoffman et al. ) . similarly, in case of healthcare, if the patient trusts the healthcare provider to fulfill his or her needs, then the patient is more likely to view technology as beneficial for him or her (lalseng and andreassen, ) studies have supported trust as a vital construct for predicting acceptance of technology (carter and bélanger, ; gefen et al., ; parasuraman et al., ; paulov, ) . studies have theoretically and empirically supported integration of trust with tam constructs. if service provider cannot be trusted by the consumer, the consumer is not likely to see any usefulness in the service provided. at the same time, trust on service provider will reduce efforts needed to verify, monitor and control the service interaction. on the other hand, if trust is low, consumer would be forced to devote more time and effort to gauge the service thus to avoid any opportunism on part of the service provider. therefore, in line with the existing literature, we hypothesize the following hypotheses. j o u r n a l p r e -p r o o f researchers have studied privacy extensively. privacy concern (pcon) has been one of the most widely used variable amongst privacy related constructs in is research. it has been one of the strongest predictors of the privacy related behavior (dinev and hart ; malhotra et al. ; stewart and segars, ) . capturing nuances related to privacy have gained significance, as it is increasingly expanding capabilities to store, process, explore and exploit personal information (dinev and hart, ) . despite growing research interest in privacy concerns, there are lack of empirical evidences as to how privacy concerns affect acceptance of technology in healthcare. privacy concern (a part of our proposed model) is considered a direct determinant of bi. the rationale is extracted out of the existing studies carried out in different domains. existing literature suggests that privacy concerns make users circumspect about using technology and sharing personal information. in sensitive areas, privacy concern of health information may even cause individuals to avoid obtaining certain healthcare services. if privacy concerns of the customer are not mitigated by the service provider, it will have significant negative effect on the consumer's attitude and behavior towards the service (milne and boza ; phelps et al. ) . in an empirical study on internet uses, dinev and hart, ( ) also found out negative impact of privacy concern on intention to use. privacy of the personal information is the focal concern of the individual (stewart and segars, ) . mukherjee and nath ( ) identified that security to privacy along with shared values positively influences behavioral intentions of the customers. this study follows the perception that privacy concerns measure the patient's assessment of lack of reliance on the service provider, especially when one has to share personal details. therefore, in line with the above presented arguments, we hypothesize the following. though various researchers have explored privacy in different contexts and environments, we found a few literatures on the effect of privacy concern on pu and peou. andrews et al., ( ) asserted that higher privacy concerns negatively mediate the relationship between perceived risk and attitude of the user. intuitively, we can argue that patients will not find usefulness in a technology that is likely to invade their privacy. individuals are likely to put more effort into monitoring if they feel that their privacy is at stake while using any service. therefore, concern for the privacy of the user will reduce the ease of use and will affect j o u r n a l p r e -p r o o f his/her perceived usefulness for any service negatively. along these arguments, we hypothesize the following. to test our model, we have adopted survey-based strategy consisting of structured selfadministered questionnaire. we considered five latent constructs and twenty-three manifest variables to measure them. methodology of research is summarized in figure . data for testing hypotheses has been collected using scenario and questionnaire-based approach. the respondents were given a scenario (presented in appendix ) before responding to the questionnaire. this approach is adopted as healthcare services linked to unique identity that does not yet exist in targeted area. however, validity of the response of individual based on a scenario has been well documented by bem ( ) . to make the scenario as realistic as possible, it was discussed with the patients in primary health centers. based on the inputs presently available electronic healthcare record systems are not designed to manage multiinstitutional, multi-format lifetime health records of patients. patients leave their health data scattered across various health service providers wherein they have availed treatment. these healthcare providers work in silos and hardly any inter-organizational data transfer takes place. whenever a patient visits any healthcare provider, either the patient carries the related previous records (in the form of case history) obtained from previous healthcare providers, or the case is registered as a fresh case. in such redundant process, lots of scarce resources that could have been provided to a new patient, are used on the same patients repetitively. to facilitate availability of medical records, we propose that healthcare records to be linked to unique identity (aadhaar -unique identification number for the citizen of india) of the patient. these records can be accessed at any health center by patients providing authentication of their unique identity. aadhaar, a -digit unique number allotted to the citizen of india, stores demographic, biometric and financial information of the individual. aadhaar number can be used as an identity and has been made mandatory for availing benefits of many governmental social schemes. as aadhaar number is linked to personal and financial information, sharing aadhaar identification can raise apprehensions about safety and security of data in the mind of individual. scenario for collection of data has been literature review on tam, trust and privacy concern development of conceptual model and hypotheses development of scenario development of questionnaire cfa and sem of collected data analysis of results and its implications j o u r n a l p r e -p r o o f developed highlighting concern of sharing aadhaar identification with healthcare provider (see appendix ). as argued by pai and huang ( ) , we designed our questionnaire on a five point likert scale with being "strongly disagree" to being "strongly agree" to collect data on demographic profile of respondents and twenty-three manifest variables. all items were adopted from published sources to ensure psychometric properties (internal consistency, testretest reliability, factor structure etc.). these measures were adjusted in consonance with healthcare environment. experts in the field of operation management examined the questionnaire for its clarity, terminology, logical consistency and contextual relevance. constructs, observed variables, questions and their sources are presented in table . questionnaire was prepared in english and hindi (local language). a pilot study was carried out on respondents, who had visited delhi government's dispensaries in the recent past. respondents were asked to give comments on wording and relevance of the questionnaire items, length of survey, difficulty, if any, in answering and time taken to complete it. based on qualitative assessment of their comments, language of the questions was simplified to make them more understandable and eliminate any ambiguity. in delhi, both government and non-government organizations provide healthcare facilities. we randomly selected dispensaries from out of districts of delhi for data collection. patients and their accompanying member(s), both females and males, in the age group of - years were approached. patients seemingly in critical medical state were not disturbed. consent from the respondents was taken before asking for their response. respondents were asked to read the scenario before giving responses. few, who were not willing to read the scenario, were personally explained. responses were received. on scrutiny, responses were rejected due to incomplete or multiple responses. in all responses were statistically analyzed for verification of our conceptual model. demographic characteristics of the sample are presented in table . and descriptive statistics are presented in table . . careful observation of the descriptive statistics presented in table . , indicates that on an average, perhaps, mean related to privacy related items are lowest as compared to items pertaining to trust, pu, peou, and bi. further, within privacy related items itself, perhaps pcon has the lowest mean, implying that respondents in general are already concerned about the providing much personal information. i am concerned about giving information to health providers. healthcare service providers are trustworthy. paulov ( ) t healthcare service provider is one that keeps promises and commitments. i trust healthcare service provider because they keep my best interests in mind. utility (pu) aadhaar linked healthcare services will enable me quick service. davis ( ) , davis ( ) , davis, bagozzi and warshaw ( ) pu using aadhaar linked healthcare services will increase productivity of service provider. aadhaar linked healthcare services will improve performance of service providers. using aadhaar linked healthcare services will enhance effectiveness of service providers. using aadhaar linked healthcare services will make it easier to get healthcare services. overall, i find aadhaar linked healthcare services system useful for me. learning to get healthcare services using aadhaar will be easy for me. davis ( ) , davis ( ) , davis, bagozzi and warshaw ( ) peou it will be easy to get healthcare service using aadhaar based service. it will be easy for me to remember how to get required service using aadhaar based healthcare service. my interaction with healthcare service providers is clear and understandable. i find [that it will not] take a lot of effort in using healthcare services. overall, i find the aadhaar based healthcare service will be easy to use. intention ( the non-response bias in this study was also tested by performing a series of t-tests between the last twenty five percent of respondents and the rest of the sample on a large number of variables in the survey following the framework developed by armstrong and overton ( ) . as the data was collected from single respondents, there is also an accompanying risk of spurious covariance between the measures in the survey, i.e., common method variance (cmv) possibly resulting in biased estimators (siemsen et al., ) . step was taken to minimize cmv and limit its potential effect on the analysis. the wordings of the survey items were refined to improve their clarity by using expert judgment (in this case by both academic and industry expert) and q-sort techniques, resulting in tentative item reliability and item validity (menor and roth, ) . evaluation of quality of measurement model is the primary stage of any structural equation modeling involving examination of convergence, content and discriminant validity, and reliability of constructs. since all the items are adopted from published research literature and experts in the field conducted item-by-item evaluation before and after the pilot study, content validity of the measurement is established (straub et al. ). construct validity is established by ascertaining convergent validity and discriminant validity. factor analysis with j o u r n a l p r e -p r o o f varimax rotation using spss is carried out to ascertain convergent validity. kaiser-meyer-olkin measure of sampling adequacy value is . , higher than justifiable value for carrying out factor analysis ( . ) (kaiser, ) . bartlett's test of sphericity is significant (table ). all the items displayed clear loading unto their five respective components as given in table . average variance extracted (ave) for all constructs and quality parameters, i.e., cronbach's alpha, composite reliability (cr) are reported in table . all measures representing constructs have cronbach's alpha above the acceptable limit of . , cr above . and ave more than . (cortina, ) confirming convergent validity, discriminant validity and reliability of the constructs. sig. . we use sem for analysis of the proposed measurement model. use of sem will substantiate robustness of findings as it is based on maximum likelihood algorithm that considers error terms in establishing loadings, correlations and other related measures. the measurement model is evaluated on primary fit criteria, overall model fit and fit of internal structure of model as proposed by bagozzi and yi ( ) . widely accepted and reported fit indices including absolute fit, incremental fit and parsimony fit indices of the conceptual model are examined (hooper at al., ) . absolute fit measures, i.e., chi-square static, gfi (goodnessof-fit index), agfi (adjusted goodness-of-fit index) and rmsea (root mean square error approximation) determine degree to which the overall model predicts the observed covariance or correlation matrix. incremental fit indices, i.e., nfi (normed fit index), cfi (comparative fit index) and nnfi (non-normed fir index) compare the proposed model to j o u r n a l p r e -p r o o f baseline model, often referred to as null model. pnfi (parsimonious normed fit index) and pgfi (parsimonious goodness-of-fit index) are termed as parsimony fit indices. these indices determine impact of additional parameters on the conceptualized model. all the indices of the proposed model obtained using lisrel are within acceptable limit are presented in table . all the fit indices were within acceptable limit indicating good model fit (mcdonald and ho, ; mulaik et al., ; pai and huang, ; schreiber et al., ) . path coefficients along with t-statistics of corresponding hypothesized paths are presented in table and figure . seven path coefficients are found considerably high and statistically significant. as per the established tam, pu is found to influence bi and peou to pu. peou influence on bi found to be insignificant. trust influence on peou is not found significant, however, trust has direct influence on pu and bi. privacy concern is found to influence pu, peou and bi negatively. the obtained results from our empirical analysis support proposed hypotheses on acceptance of technology in healthcare. however, the significance of individual hypotheses warrants further discussion. this research examines technology acceptance in healthcare services, hypothesizing and validating role of trust and privacy concerns. in addition to reaffirming relations of original tam constructs, our results elucidate that trust and privacy concern directly affect patients' intention to use technology in healthcare services. growing interest in patients' reaction to introduction of technology in healthcare has given impetus to theories that predict and explain technology acceptance and usage. the results suggest that while enhanced trust positively affects behavioral intention and perceived utility of the service, privacy concern, on other hand, has negative effect on behavioral intention, perceived utility and perceived ease of use of medical services. in particular, the studies carried out by andrews et al., ( ) and honein-abouhaidar et al., ( ) are important to be discussed here, since both of these studies, investigated the acceptance of technology by people availing healthcare services. andrews et al., ( ) , while investigating australian general public perception of adopting a personally controlled electronic health record (pcehr), argued that individuals appreciate the value associated with pcehr. however, adoption of pcehr was explained by perceived value and perceived risk. further, individuals also liked to have two key concerns, viz., reduction in privacy and lack of trust to be mitigated before committing to pcehr. however, how and to what degree trust and privacy concerns impact the behavioral intentions of individuals is something ascertained by our study. unlike the study by andrews et al. ( ) , our study also considers the relationships amongst behavioral constructs and perceived utility associated with adoption of technology in healthcare delivery. trust does not seem to have significant effect on ease of use of any technology in healthcare. all hypotheses are confirmed through empirical assessment. the results also confirm findings of similar studies carried out in online services. however, evaluation of effect of trust and privacy concern on technology acceptance in healthcare services provides the aspect of originality in respect of existing literature. our results in regard to behavioral intention also somewhat support the findings from honein-abouhaidar et al., ( ) arguing that positive relationship exists between perceived utility and behavioral intention in adopting electronic patient portal (epp). our study supports earlier literature on trust and transactions and confirms their relevance in healthcare services also. data from primary health centres shows that trust has direct bearing on behavioural intentions of patients to use the service or avoid to it. the study also establishes positive relationship between trust and perceived utility. based on these results, we can assert that trust is an enabler of acceptance of technology in healthcare services. the results also demonstrate that privacy concerns of patients are negatively associated with perceived utility, perceived ease of use and as a result behavioural intention of adaptation of new technology in healthcare. our results support previous studies, carried out in different services, which suggest that if consumers' privacy concerns are not mitigated, they will have negative impact on consumers' decision on availing that service (eastlick et al., ) . given the potential repercussion on consumer's attitude, it is essential j o u r n a l p r e -p r o o f that researchers accurately understand the concern related to consumer's information privacy. above analysis synthesizes the assertion that privacy concern is an inhibiter of acceptance of technology in healthcare services. following implications can be clearly derived from the research analysis discussed above. from managerial point of view, major implications of this study can be summarized as follows. firstly, in today's technologically intensive and competitive health care domain, the citizens' need (particularly in developing countries) is oriented around high quality care at an affordable cost. health care managers, therefore, must find cogent ways to obtain superior healthcare results considering rather limited resources. secondly, as numerous studies have shown that adoption of new technologies in healthcare can provide quality healthcare to all socioeconomic strata of the society particularly in rural and remote areas, it is pivotal for healthcare service providers to understand the driving forces of patients' acceptance of technology. this study demonstrates factors that affect behavioural intentions of patients in acceptance of newer technologies. thirdly, this study reflects needs for strategic planning, assessing and understanding the role of trust to allay ethical concerns related to the user sensitive data. finally, success of any e-health program hinges on acceptance of technology to put in place robust it enabled models designed for providing access to affordable healthcare. it mandates service managers to strive for greater technology acceptance amongst patients. on theoretical front, this research provides significant contributions in establishing link between behavioral aspects and acceptance of technology in health services. the study explores a vital issue of patients' trust and their privacy concerns in context of new technology acceptance, thus providing a theoretical foundation to understand behavioral responses of patients on introduction of a new technology in healthcare service delivery. additionally, our study also contributes to the extant literature by proposing and testing extended tam by integrating behavioral constructs in healthcare context. adapting to the conceptualization of trust and privacy concern in various other services, this research reaffirms effect of these constructs on acceptance of technology in healthcare services. this approach will help us in building a holistic picture of technology acceptance in healthcare. this study suggests that perceived usefulness, perceived ease of use, trust and privacy concerns are valid predictors of technology acceptance in healthcare service delivery. our study lends support to theoretical foundation of tam in healthcare setting associated with credence, co-creation and co-production, and vulnerability of service receiver as few key attributes. partly, implementation of new technology in healthcare is marred by lack of engagement of the service consumers. theoretically, existing literature is rather inadequate in satisfactorily exploring contingent factors emerging from application of smart technologies in public healthcare (papa et al., ) . this study provides relationship between an individual's behavioral constructs and final acceptance of technology in healthcare service setting. countries have been spending significantly on new technologies for improving healthcare service delivery. however, when adopted technology is not acceptable to the patients, then the purpose of these technological advancements gets defeated. despite notable gains in improving life expectancy, improving maternal and child mortality outcomes and addressing other health priorities, the rate of improvement has been far from satisfactory (particularly in developing world). for policy makers and researchers, this study does a redressal of four issues to obtain acceptance and desired outcome of technology being introduced in healthcare services. firstly, introduced technology must focus on expected usefulness to the patients. secondly, service providers must focus on ease of use and convenience associated with the technology. thirdly, trust has been found to impact patients' perception of utility and thus, behavioral intention to use that technology. while expected use and ease of use can be explained to the user, trust is something, which has to be earned. onus here lies with implementing agencies (health centers in this case) and the governments to develop trust amongst patients for delivery of healthcare services. finally, privacy concern has influence on utility, ease of use and final acceptance of any technology. like trust, apprehensions related to privacy concern of the patients have to be mitigated by the implementing agencies and the government. technology induction in healthcare will not only create value for patients, but also for the entire social and economic ecosystem. in india, availability of enabling technologies like mobile internet, cloud computing and social media augmented by favorable demographics and healthcare infrastructure can create a fertile ground for induction of technologies in health care delivery. various governmental direct benefit schemes are already linked with aadhaar numbers of citizens. however, j o u r n a l p r e -p r o o f healthcare services are yet to be linked to any unique identity in the country. one such study proposed blockchain and big data assisted, unique id linked model for universal healthcare coverage (dhagarra et al., ) . as an augmentation to dhagarra et al., ( ) , this research delineates behavioral factors to be considered while implementing any technology assisted healthcare model for achieving universal healthcare coverage. as already ascertained by extant studies (andrews et al., ) , mitigating privacy related concerns in patients' minds thus ensuring enhanced trust between patients and service providers, is crucial to success of medical services delivery including e-services. in this regard there are certain concrete steps can be taken by the concerned stakeholders including both government and healthcare providers. in indian context and on a governmental level, of particular interest would be hipaa (health insurance portability and accountability act of ) and eus safe harbor law (barua et al., ) . these laws usually mandate strict security measures for sharing and exchanging health data, and failure to comply with them is accompanied by severe penalties. from the standpoint of health care service providers, only authorized users such as medical staff should have access to the collected health data as it almost always contains confidential and sensitive data. this security critical system, however, requires careful balancing between confidentiality and availability. the dichotomous nature of these two goals is clear: while all the patient's data should be available to be shared and monitored to deliver professional healthcare services; for security reasons, part of the data may be considered confidential and therefore must not be accessible. clearly, rationalization of the paired goals should be achieved to provide the best possible care for patients. further, when dealing with privacy concerns in e-healthcare models, security models revolving around data collection, data transmission, and data storage would have to be designed carefully (zriqat et al., ) . of particular interest in this context would be use of blockchain concept for patients' registration and handling of medical record as proposed by dhaggara et al., ( ) as a way of creating immutable and secure framework. to the best of authors' knowledge, this is first study aimed to explore technology acceptance linking unique identity with healthcare records in india. since such conceptualization is yet to be implemented, there exists many limitations in our study. we recommend a pilot project implementing integration of healthcare records based on unique identity. this study has been carried out in urban area of one city of the country wherein the respondents were relatively j o u r n a l p r e -p r o o f young and educated. educated respondents therefore pose less of a challenge as far as interpretation of survey responses are concerned. though data has been collected by randomly selecting healthcare centers and patients, it may not reflect huge diversity of the population. to further validate present findings, proposed model may be investigated in different countries in different geographical spreads. model may further be cross validated in developing and developed countries. this will further boost the reliability of results and may result in some degree of generalization of managerial and theoretical inferences. to further boost robustness and validity of the proposed model, study may be replicated with larger sample size and at different levels of healthcare services like in specialty hospitals. finally, the study investigates effect of only two additional behavioral constructs on technology acceptance in healthcare delivery. future study may include more behavioral constructs to study their effects on technology acceptance in healthcare. of particular interest would be to include behavioral constructs that can explain patients' behavioral and psychological traits in the time of pandemics (for instance the ongoing covid- situation). psychological interventions for all or specific (e.g., more vulnerable) groups aimed at identification of adverse psychological impacts and psychopathological symptoms in the general population during the pandemics would be of use to governments and healthcare service providers. the methodological analysis as carried out in our study can be further refined by taking into account the fixed and random effects. in particular, the motivation for using fixed effect (fe) and random effect (re) regression model would emanate from identification of such effects explaining variations on measurement items related to output variables, i.e., variables explaining behavioral intention in our case (martin et al., ) . however, such methods, for instance, those related to fe (e.g., ordinary regression, uni/multivariate regression models) and re including meta-analysis related (e.g., hunter-schmidt/hedges-vevea) are often considered data hungry methods, wherein some important questions such as how much and what kind of data need to be collected to deploy such models meaningfully and reliably need to be addressed. questions, for instance, whether the data would be pooled in nature or individual respondent based would also aid practitioners in determining the right sampling strategy (martin et al., ) . schmidt et al. ( ) in their study discussed comparison of fe and re model for empirical data. they argued that results often vary substantially given the type of model used since fe is often associated with apriori while re takes into account statistical calibration. further, j o u r n a l p r e -p r o o f deploying fe models and generalizing findings are often dichotomous in nature in that fe models can lead to inflated type i error rates and erroneously narrow confidence interval (hedges & vevea, ; hunter & schmidt, ) . with the advent and phenomenal growth of new technologies based on big data, cloud computing, and blockchain, technology usage is rapidly increasing due to numerous advantages. in healthcare service delivery, technologies concerning professionals, like online appointments, data recording for diagnosis and tracking, etc., are increasingly being adopted. moreover, not only professionals, but patients and their relatives also get influenced by technology. intent of this empirical work was to explore constructs that affect patients' acceptance of technology in healthcare. technology in healthcare has many advantages and at times seems to be only answer to the enormous task of providing universal health coverage. however, for implementation and acceptance of technology in this sector, practitioners and researchers have to take behavioral traits of patients into consideration as well. this empirical study presents an extension to the well-established tam model. primary contribution of this study is integration of behavioral variables (trust and privacy concern) with tam constructs into a parsimonious model that predicts patients' acceptance of technology in healthcare service. this study suggests that trust, privacy concern and perceived utility shape patients attitude towards technology acceptance; while trust and privacy concern directly influence perceived utility. as healthcare service is often characterized by credence of highest degree and different from other services on many accounts, there remains significant scope of unauthorized exploitation of patients' health data. this study suggests that patients' fears about losing privacy has to be dispelled for their acceptance of any newer technology. practitioners and agencies responsible for healthcare need to earn trust of patients before implementing any new technology. the study empirically establishes relationship between trust and privacy concern of patients with their intention of technology acceptance. based on a scenario, the data was collected from primary health centers in india to understand various constructs and to test related hypotheses. based on results and analysis, theoretical and managerial implications are drawn and discussed in detail. one morning you wake up suffering from fever and headache. you had similar problem a few weeks ago and you got all your tests done. you took medicines as prescribed by the doctor. now you feel worried and would like to get in touch with a medical doctor to receive a diagnosis and treatment. you have two options: you may collect all your previous treatment case history, reports, prescriptions, etc., and preferably go to the same doctor from whom you received your treatment on the last time. second option is that, you carry your aadhaar card and go to any health center, which is capable of providing healthcare services by using your aadhaar data. if you choose second option, you have to give your thumb impression to identify yourself. after identification, your all the medical records will be available with the doctor. you don't have to carry any of your previous health records. the doctor, after examining your records and previous diagnosis, will be able to prescribe future course of action. with more certainty, the doctor will be able to decide which tests need to be done. whatever treatment you receive here, everything will be added to your health history so that next time whenever you need health service, you don't have to carry any physical record with you. just by identifying yourself by giving your thumb impression at any health center, all your previous treatment details will be available with stationed doctor there. i am sure that you are aware that your aadhaar is linked with your bank accounts, and other financial subsidies you receive from government. however, such data is safe and secure. at a health center, only your health related data will be accessed. j o u r n a l p r e -p r o o f research commentary-the digital transformation of healthcare: current status and the road ahead estimating nonresponse bias in mail surveys the role of big data analytics in internet of things the theory of planned behavior an extension of the technology acceptance model in an erp implementation environment the australian general public's perceptions of having a personally controlled electronic health record (pcehr) annual report - . government of national capital territory of delhi, directorate general of health services privacy in practice: professional discourse about information control in healthcare evidence of the effect of trust building technology in electronic market: price premium and buyer behaviour on the evaluation of structure equation models the impact of personal dispositions on information sensitivity, privacy concern and trust in disclosing health information online an alternative interpretation of cognitive dissonance phenomena healthcare: a fertile field for service research the differential performance effects of healthcare information technology adoption a concept of a patientcentered healthcare system based on the virtualized networking and information infrastructure the importance of trust for personalized online advertising consumer trust repair: a critical literature review the benefits of health information technology: a review of the recent literature shows predominantly positive results the utilization of e-government services: citizen trust, innovation and acceptance factors the meaning(s) of trust. a content analysis on the diverse conceptualizations of trust in scholarly research on business relationships systematic review: impact of health information technology on quality, efficiency, and costs of medical care personalization versus privacy: an empirical examination of the online consumer's dilemma social values in health priority setting: a conceptual framework u.s. adoption of computerized physician order entry systems an attitudinal model of technology-based selfservice: moderating effects of consumer traits and situational factors consumer evaluations of new technology-based self-service options: an investigation of alternative models of service quality user acceptance of computer technology: a comparison of two a technology acceptance model for empirical testing new end-user information systems: theory and results. doctoral dissertation, mit perceived usefulness, perceived ease of use, and user acceptance of information technology electronic health records in ambulatory care-a national survey of physicians examining the impact of information technology and patient flow on healthcare performance: a theory of swift and even flow (tsef) perspective it capability for health care delivery: is more better? big data and blockchain supported conceptual model for enhanced healthcare coverage: the indian context internet privacy concerns and social awareness as determinants of intention to transact an extended privacy calculus model for e-commerce transactions an examination of the nature of trust in buyer-seller relationships understanding online b-to-c relationships: an integrated model of privacy concerns, trust, and commitment medrec" prototype for electronic health records and medical research data. white paper belief, attitude, intention and behavior: an introduction to theory and research utility-driven data analytics on uncertain data determinants of long-term orientation in buyer-seller relationships a research agenda for trust in online environments trust and tam in online shopping: an integrated model technology acceptance in health care: an integrative review of predictive factors and intervention programs consumer e-shopping acceptance: antecedents in a technology acceptance model the limits of trust-free systems: a literature review on blockchain technology and trust in the sharing economy retrust: attack-resistant and lightweight trust management for medical sensor networks fixed-and random-effects models in metaanalysis information privacy in online social networks: uses and gratification perspective building consumer trust online the technology acceptance model: its past and its future in health care structural equation modelling: guidelines for determining model fit users' acceptance of electronic patient portals in lebanon trust: the connection link between organizational theory and philosophical ethics human development for everyone fixed effects vs. random effects meta-analysis models: implications for cumulative research knowledge investigating enterprise systems adoption: uncertainty avoidance, intrinsic motivation, and the technology acceptance model privacy concerns on social networking sites: interplay among posting types, content, and audiences use of electronic health records in u.s. hospitals privacy concerns and privacy-protective behavior in synchronous online social interactions an index for factor simplicity organizational and environmental determinants of hospital emr adoption: a national study trust in health information websites: a systematic literature review on the trust a meta-analysis of the technology acceptance model information hangovers in healthcare service systems electronic healthcare: a study of people's readiness and attitude toward performing self-diagnosis understanding consumer privacy: a review and future directions facebook privacy management strategies: a cluster analysis of user privacy behaviors the technology acceptance model: past, present, and future examining individuals' adoption of healthcare wearables devices: an empirical study from privacy calculus perspective hospital technology and nurse staffing management decisions empirical studies on online information privacy concerns: literature review and an integrative framework. communication of the association for information system bsein: a blockchain-based secure mutual authentication with fine-grained access control system for industry . creating sustainable healthcare system using local health information to promote public health health promotion in the digital era: a critical commentary internet users' information privacy concerns (iuipc): the construct, the scale, and a causal model public standards and patients' control: how to keep electronic medical records accessible but private measuring individual differences in reaction norms in field and experimental studies: a power analysis of random regression models the adoption of hospital information systems the effect of health information technology on quality in u. s. hospitals principles and practice in reporting statistical equation analyses the quality of healthcare delivered to adults in the united states the impact of initial consumer trust on intentions to transact with a web site: a trust building model towards bayesian-based trust management for insider attacks in healthcare software-defined networks new service development competence in retail banking: construct development and measurement validation online health information seeking: the influence of age, information trustworthiness, and search challenges trust and concern in consumers' perceptions of marketing information management practices role of electronic trust in online retailing: a re-examination of the commitment-trust theory evaluation of goodness-of-fit indices for structural equation models applying the technology acceptance model to the introduction of healthcare information systems e-health and wellbeing monitoring using smart healthcare devices: an empirical investigation an updated and streamlined technology readiness index: tri . technology readiness index (tri): a multiple item scale to measure readiness to embrace new technologies situation awareness, mental workload, and trust in automation: viable, empirically supported cognitive engineering constructs cloud based rural healthcare information system consumer acceptance of electronic commerce: integrating trust and risk with the technology acceptance model fog computing for sustainable smart cities: a survey poverty and access to health care in developing countries antecedents and consequences of consumer privacy concerns: an empirical investigation privacy concerns and consumer willingness to provide personal information an automated picking workstation for healthcare applications the public's trust and information brokers in healthcare, public health and research the quest for privacy in the internet of things the future of healthcare internet of things: a survey of emerging technologies doctors' orders--if they're electronic, do they improve patient satisfaction? a complements/ substitutes perspective a systematic review of the technology acceptance model in health informatics an innovation-diffusion view of implementation of enterprise resource planning (erp) systems and development of a research model a cloud computing solution for patient's data collection in health care institutions not so different after all: a cross-discipline view of trust fixed-versus random-effects models in meta-analysis: model properties and an empirical comparison of differences in results an integrative model of organizational trust: past, present, and future reporting structural equation modeling and confirmatory factor analysis results: a review common method bias in regression models with linear, quadratic, and interaction effects the impact of health information technology bundles on hospital performance: an econometric study information privacy: measuring individuals' concerns about organizational practices healthy bodies and thick wallets: the dual relation between health and economic status why different trust relationships matter for information systems users an empirical examination of the concern for information privacy instrument ehr acceptance among austrian resident doctors validation guidelines for is positivist research. communications of the association for information systems empirical evaluation of the revised technology acceptance model personal health records: definitions, benefits, and strategies for overcoming barriers to adoption research for universal health coverage unique identification authority of india, government of india a theoretical extension of the technology acceptance model: four longitudinal field studies determinants of perceived ease of use: integrating control, intrinsic motivation, and emotion into the technology acceptance model user acceptance of information technology: toward a unified view poverty and health sector inequalities an artificial intelligence driven multi-feature extraction scheme for big data detection big data analytics: understanding its capabilities and potential benefits for healthcare organizations secure authentication scheme for medicine anti-counterfeiting system in iot environment a novel authentication and key agreement scheme for implantable medical devices deployment towards effective trust-based packet filtering in collaborative network environments world health organization. the global burden of disease the adoption of mobile healthcare by hospital's professionals: an integrative perspective examining the formation of individual's privacy concerns: toward an integrative view the personalization privacy paradox: an exploratory study of decision making process for location-aware marketing an empirical study of patients' privacy concerns for health informatics as a service a security and trust framework for virtualized networks and software-defined networking two schemes of privacy-preserving trust evaluation emerging information technologies for enhanced healthcare a chronological review of empirical research on personal information privacy concerns: an analysis of contexts and research constructs security and privacy issues in healthcare systems: towards trusted services big data for supply chain management in the service and manufacturing sectors: challenges, opportunities, and future perspectives factors influencing behaviour intentions to telehealth by chinese elderly: an extended tam model securing m-healthcare social networks: challenges, countermeasures and future directions the impact of privacy concern on user adoption of location-based services key: cord- -xjb k n authors: kar, arpan kumar title: what affects usage satisfaction in mobile payments? modelling user generated content to develop the “digital service usage satisfaction model” date: - - journal: inf syst front doi: . /s - - - sha: doc_id: cord_uid: xjb k n mobile payment services have become increasingly important in daily lives in india due to multiple planned and unplanned events. the objective of this study is to identify the determinants of usage satisfaction of mobile payments which could enhance service adoption. the “digital service usage satisfaction model” has been proposed and validated by combining technology adoption and service science literature. first the data was extracted from twitter based on hashtags and keywords. then using sentiment mining and topic modelling the large volumes of text were analysed. then network science was also used for identifying clusters among associated topics. then, using content analysis methodology, a theoretical model was developed based on literature. finally using multiple regression analysis, we validated the proposed model. the study establishes that cost, usefulness, trust, social influence, credibility, information privacy and responsiveness factors are more important to increase the usage satisfaction of mobile payments services. also methodologically, this is an endeavour to validate a new approach which uses social media data for developing a inferential theoretical model. the use of mobile payment services has witnessed a lot of growth due to planned and unplanned interventions in india. on th november , the government of india announced the demonetization of all larger currency notes (mohan and kar ) . further, policy changes were announced by service providers to promote the use of mobile payments in and , like discounts and cash-backs. so after demonetization, there has been tremendous focus to enhance the usage of mobile payment services in india. national initiatives in india like digital india, also attempted to contribute to the growth of mobile payments, with initiatives like targeting very high mobile connectivity and internet penetration along with digital literacy missions for the rural households (joseph et al. ; mukherjee et al. ) . similarly, with the pandemic, covid- , which started in january ; globally mobile payment usage witnessed a significant boost as concerns were raised that cash may become a carrier for the virus, and thereby facilitate the spread of the pandemic. the main reason for the promotion of mobile payments services is to make the citizens digitally empowered, reduce intermediation and thereby make the society cashless, paperless and faceless. mobile payments services play a vital role in this twenty-first century, as in this digital world, the users have their own phone and through few clicks users can easily transfer money without the constraints of geographical distance between payer and payee, access to paper bills and time (grover et al. ) . mobile payments is a subset of electronic payments which enables payments of good and services without any use of paper cash and payments is done by using wireless and other communication channels (dahlberg et al. ) . in other words, mobile payments empower individuals to make online payments for any products and services such that there is no constraints of physical proximity, geographical barriers and traceability of payments through a mobile phone with internet connectivity. mobile payment service providers play an important role to increase the economic growth of a country like india as they also provide or enable a host of digital services such as fund transfer, micro-financing, short term loans, online ticketing, online shopping and payment for utilities (grover et al. ) . it means that there is no need to carry paper cash while engaging in these activities of daily life. due to the worldwide growth of the internet and the growing popularity of electronic commerce, mobile payments play an even more critical role in this economy (yu et al. ) . there are many efforts globally to increase the mobile payments services and to remove tangible cash in society. however acceptance of mobile payments is highly dependent upon usage experiences like other information systems (wixom and todd ) . technologies have been giving new directions not only to societies but also industries. finance companies and technology companies have come together to different new business models for mobile payments (puschmann ) . these new models provide an online platform between users and merchants to engage without the physical transfer of cash, thereby crossing the challenges of access to cash, geographic barriers, economic barriers and even on credit. mobile wallets services allow peer-to-peer transaction between merchants and users and transactions are can be done without any geographical constraints (tankovic and benazic ) . recent review of customer experience literature also indicates that there is a lack of studies measuring customer experience immediately after digital service encounters (becker and jaakkola ) . this gap may be due to the challenge for researchers whereby it becomes difficult due to the distance of the context and the researcher at the time of service encounter; when the incident that triggers any unexpected reaction. however firms can continue to measure it by sharing a close-ended survey with the customer. in this context, the prime objective of this study is to identify which factors are responsible for impacting the service encounter usage experiences during a specific service encounter of mobile payments services in india. in this context, we propose the digital service usage satisfaction model (dsusm), which is validated in the context of mobile payments. usage satisfaction is different from user satisfaction and is tied to a single context in a particular instance in which a service encounter is analysed. whereas, user satisfaction is mainly captured as the sum (or average) of overall experiences of service encounters over a period of time (wixom and todd ) . a novel research methodology has also been adopted to fulfil this objective. this study is undertaken by mining the user discussions surrounding the service consumption and subsequent experiences surrounding them. this user generated context has been analysed using text mining approaches like topic modelling and sentiment mining. then the summarized topics have been mapped to constructs of technology adoption identified from literature. the usage experiences have been modelled for the topics using sentiment mining. the relationship of the factors affecting adoption and their associated service experiences have been validated using multiple regression analysis. in particular, our study is guided by the following research questions. the first four of which are in the domain of mobile payment service science and the last research question addresses a methodological gap in existing social media analytics driven research. rq : how do users discuss about usage experiences surrounding service encounters of mobile payments? rq : what are all the antecedents that impact usage satisfaction during service encounters of mobile payment across user groups? rq : how are these antecedents that impact the service usage satisfaction associated with each other? rq : how do these antecedents impact usage satisfaction during service encounters of mobile payments? this rest of the study is divided into seven sections. in the second section, we provide an overview of the related literature. in the third section, we describe the research questions and hypothesis which has been used for theory building. the fourth section describes the research methodology of the study. the fifth section describes the findings of our study. the sixth section describes the implication of these results. the seventh section describes the conclusion which is derived from the study. the eighth section describes the limitation of this study and concludes with future research directions. the literature review is divided into the three sections: ( ) adoption of mobile payments services; ( ) service experience discussion in social media; ( ) research gap and contribution of the current study. literature indicates that technology plays a vital role in increasing the growth of mobile payments service in purchasing good and services. while adopting any technology facilitated service, a number of theories have been used in existing literature and adoption is one of the more popular areas in information systems discipline. dominant theories in in the technology adoption literature are theory of reasoned action (tra), technology acceptance model (tam), theory of planned behaviour (tpb), diffusion of innovation (doi), theory of interpersonal behaviour (tib), unified theory of acceptance and use of technology (utaut), model of adoption of technology in households (math) and motivational model. several studies have attempted to add more constructs to explain adoption behaviour better over the years. an overview of the fundamental theories and their constructs are illustrated in table . adoption literature focused on electronic payments indicates that significant effects towards use are derived out of the ease of use, perceived quality of such services and satisfaction over a period of continued usage (jun and cai ; rana et al. ; slade et al. ; teoh et al. ) . these studies indicate that to promote electronic payments, it would be necessary to explore the frameworks which assess the quality of such digital services. further adoption of electronic payment services depends upon the country environment, culture, technology and government (berthon et al. ). reviews of literature on the consumption of mobile application services identified factors such as perceived quality, usefulness, social-influence, flexibility have played a powerful role in increasing its adoption rate (chhonker et al. ). reviews on extended theories of adoption literature indicate a plethora of additional constructs along with these main constructs as indicated in table are available, like perceived trust, perceived security, price value, performance expectancy, to name a few (slade et al. ; rana et al. ; chhonker et al. chhonker et al. , dwivedi et al. ; tamilmani et al. ) . adoption literature on mobile payments also highlight the relevance of theories on user resistance to such changes due opportunity appraisal factors like perceived value, threat appraisal factors like consequences of using new systems and secondary appraisal factors like sense of control while using such platforms (gong et al. ) . these theories on adoption are sometimes explored using service science theories, like servqual and webqual, using factors like responsiveness, tangibility, reliability, assurance, empathy (parasuraman et al. ). these models are widely used to measure the perception of customer towards the service quality: a gap between services the customer expected to receive and what they have been received, even in technology enabled services (parasuraman et al. ; loiacono et al. ). further literature (dahlberg et al. ; zhou ) highlights the importance of factors like risk, security, usefulness, socialinfluence, information-privacy, trust, usefulness also important service quality factors. these frameworks like servqual and webqual very useful to evaluate the customer expectations and their perception towards firms in terms of their service delivery (loiacono et al. ). further, reviews of literature (chhonker et al. ; southard and siau ; hong and tam ) identified that factors like assurance, confidentiality, usefulness, trust, security, customer attitude, credibility, reliability, ease of use, cost, tangibility, performance, responsiveness, social influence, and information-risk which could affect the perceived quality of services significantly based on a single service encounter and thus impact the adoption of digital services like electronic payments. overview of these factors are illustrated in table . literature indicates that there are many other factors, but we have briefly described factors which have been identified as being relevant in our study, through the process of looking at the data obtained from summarization of texts of user generated content. in this digital world, seventy percent of customers used social media sites to access information, forty-nine per cent of customers use social media sites for taking any purchase decision based on information present in the social media sites, sixty per cent users use social media sites only to share their views with others; forty-five per cent users use social media sites only for word-of-mouth (kim and ko ; tan and lee ) . electronic word of mouth related to service encounters and access to internet impact intention to use a technology enabled service (chaudrie and dwivedi ; ismagilova et al. ) . social media platforms like facebook and twitter play an important role in this digital world for sharing information, to maintain public relation, and to exchange opinion among users (grover et al. ) . social media sites are platforms in which social or professional friends interact with each other for sharing their ideas or opinions (trusov et al. ).in this digital world, all users using social media sites for marketing (thackeray et al. ) , for the promotion of their product and services (neiger et al. ) , for increasing job opportunities (henderson et al. ) , governments organizations use social media sites as a communication channel for the public (kim and ko ; chang and wang ) . various industries use social media sites for the marketing of their products and services such as retailing, tourism, news, entertainments industry (grover et al. ) . marketing is done in social media sites for any products and services with less effort and cost, it also maintains the strong relationship with their customer and increases the profits of the industries (kim and ko ) . firms also engages with customers in social media in a number of ways. first is in the traditional form in which there is a direct communication between customers and the organization through paid promotion. the second form is social communication in which users communicate with other users then they discuss the user experiences about the product and services delivers by any organizations and industries (paniagua and sapena ; mangold and faulds ) . communication between firms and customers over social media is not only cost effective, but also helps in building brand engagement and strengthens customer relationships (zheng et al. ) . social media is one of the (venkatesh et al. ; gholami et al. ) security maintaining confidentiality, authenticity, non-repudiability between users and services. (papa et al. ) social influence views of support or prestige associated among social groups and peers when a service is used (koenig-lewis et al. ) information risk the risk of information getting affected, accessed or misused when information interchange happens in a transaction (slade et al. ; leong et al. ). the extent that a user's trusts the promises of service delivery by the firm. (parasuraman et al. ) assurance ability to convey confidence that the service provider will act in the interest of the user and deliver what it was supposed to do. (parasuraman et al. ) customer support (attitude) the orientation of the service provider to support the customer's needs for issues related to service consumption (arvidsson ) responsiveness how quick is the service provider to address issues when a service request is raised by a user? (lin ) confidentiality information should be restricted among the parties involved in the transaction. (meharia ) information privacy the personal and sensitive information collected during a transaction will not be shared or used beyond intended usage or user groups (tsai et al. ) reliability the systems will continue to provide uniform quality of services outcome over time. (parasuraman et al. ) dominant platforms for users in which they can resolve their queries related to new technologies, products and services (kapoor et al. ; rathore and ilavarasan ) . users frequently attempt to interact and engage with firms based on their service encounters and share their inputs for improving quality of services (howard et al. ; rathore and ilavarasan ) . our review of literature on digital service science in general and mobile payments in particular reveal the following overview and gaps which we attempted to address: & studies have attempted to find antecedents to technology adoption a lot in existing literature but the connect with usage experience is missing. & studies have focused on service delivery process and service quality as an outcome extensively in service science literature. & studies indicate that service quality literature is also connected to adoption and establishes that good perceptions surrounding service quality facilitates adoption. & however there is no study to measure digital service usage experience by connecting these two bodies of literature, especially by mining user generated content. & further there is no attempt to establish antecedents of service usage experience in existing digital service usage behaviour, as researchers are distanced from the customer at the time of service encounter. usage experience at the point of service consumption is difficult to capture by researchers who are external to the encounter. the current study is a major leap in this direction to combine approaches of social media analytics with inferential analysis to develop such a large integrative perspective by proposing the dsusm model. this requires us to explore the first two research questions which are predominantly exploratory in nature. our first research question attempts to explore whether users share their usage experience on digital service consumption, and if they do, what kind of polarity are typically highlighted in such social media discussions. this enables us to measure sentiments of the core tweets which will later be used to measure usage satisfaction as a dependent variable. twitter is one of the popular microblogging platforms and has the potential for capturing mutual intelligence from large numbers of users (grover et al. a) . also by this approach, a complex theoretical model may be developed which otherwise is not feasible to validate through survey based methods, since the survey instrument would be too long to collect responses without creating any stress or biases among respondents. we developed our hypotheses with the theoretical models extended from different technology adoption and service quality models and further added certain constructs to extend the already existing theories surrounding adoption. we begin by discussing fifteen hypotheses that were related to the mobile payment's services. the dependent variable is usage satisfaction (extended from venkatesh et al. ; lin and sun ) , defined as the individual probability towards the use of technology. in this study, the polarity of a user's sentiment in a context of user generated content, has been used as a proxy for usage satisfaction. if an user is satisfied, the assumption is that the polarity of the tweet will have a positive sentiment. similarly, if the user is not satisfied from a service encounter, the assumption is his tweet will have a negative polarity in terms of sentiment. further it was necessary to identify antecedents which would affect this usage satisfaction. for this, we had to adopt an inductive research methodology whereby revisit the data carefully and identify factors from the summarization of social media discussions. this exploratory study is undertaken to address the second research question whereby we attempted to address the second research question by connecting the outcome of text summarization with the understanding of literature based on reviews. based on text summarization methods, fifteen factors could be identified from existing literature. the methodology of identifying these factors is elaborated in the research methodology. these independent variables were cost (shon and swatman ) , usefulness (davis et al. ; karnouskos ) , trust (yousafzai et al. ) , information-risk (slade et al. ) , security, social influence (koenig-lewis et al. ) , ease of use (venkatesh et al. ) , performance (venkatesh et al. ) , credibility (wang et al. ) , reliability (zhu et al. ) , informationprivacy (leong et al. ) , responsiveness (lin ), customer-attitude (davis et al. ) , confidentiality (meharia ) , and assurance (wang et al. ) , as illustrated in fig. . in subsequent part of this theory development section, we attempt to address the third and fourth research question for developing the theoretical model for validation. usage satisfaction customer perception and satisfaction surrounding a service encounter play a vital role for getting the success of any new technology, therefore mobile payments services get adopted only when customers have positive perception and usage satisfaction towards mobile payments services (oliver ; sun et al. ). literature indicates that adoption of online transaction is highly governed by customer satisfaction and their choices of method of transaction (dahlberg et al. ) . however customer or user satisfaction typically emerges over multiple service encounters whereas usage satisfaction is generated at the context of service encounter (wixom and todd ) . such a measure for customer satisfaction would be typically captured as the sum or average of different usage satisfaction out of numerous service encounters. typically, most of the past literature measures overall customer satisfaction since measuring usage satisfaction is difficult due to access to the customer at the moment of service consumption. however firms typically ask users to rate their service encounters after a service is consumed as it helps in service improvements and can create positive or negative user generated content which is a better measure for usage satisfaction. however getting access to individual such ratings after service consumption may be challenging unless we use the user generated content surrounding this service encounter. recent reviews of literature also highlight that measuring customer experience at the point of service encounters becomes difficult during digital service usage by customers (becker and jaakkola ). however this user generated content or electronic word of mouth may affect future use of the service (ismagilova et al. ) . in this study, a customer's usage satisfaction from the mobile payment service encounter has been captured through a proxy of the sentiment of a topic which is identified through text summarization in user-generated content. the topic represents the usage context and associated words relevant to the context which multiple customers may have shared while sharing their experience regarding a service encounter. usage satisfaction is the dependent variable in our study which is captured using sentiment mining methods derived from social media analytics by analysing the polarity of the topic. cost (price) this factor captures the cost of using mobile payments services while engaging in a transaction. cost of onboarding into a system or for completing a transaction should be lower for increasing the acceptance rate of digital services (mallat ; liang and huang ) . literature indicates that higher cost per transaction, communication cost and subscription cost often affect the consumption of digital services in both individual and organizational setting (shafinah et al. ; chatterjee and kar ) . there are evidences in utaut that price has a significant impact on behavioural intention. hence extending this argument, we felt that cost would also impact usage satisfaction, if this cost was associated with every usage (like cost per transaction). therefore we hypothesise h as follows. h : there is a negative relationship between cost and usage satisfaction usefulness digital payment models facilitates the user to withdraw their money anywhere at any time with very minimal charges (omwansa ). it posits that a technology driven platform should have tangible benefits which would promote their adoption as well (davis ) . if the users percieve that mobile payments are more useful, as compared to other modes of payments, they should have a positive impact on usage satisfaction. therefore we propose h as follows. fig. a holistic framework for the assessment of usage satisfaction of mobile payments h : there is a positive relationship between usefulness. and usage satisfaction. trust trust is basically used to identify how much risk associated while doing any financial transactions i.e. trust is directly proportional to usage satisfaction, if trust increases then the perception of users towards mobile payments automatically increases. trust helps to maintain the transactional relationship between merchant and customers (peha and khamitov ) . trust plays an important factor in the adoption of mobile services because the online transaction, besides being intangible, a significant degree of perceived risk and unpredictability is involved (slade et al. ; salo and karjaluoto ; arif and du ) . antecedents of trust are factors like talent, kindness and honesty (kassim and abdullah ; sebastianelli and tamimi ) . talents mean that the service providers have knowledge and experience to deliver the desired services. honesty means that the service provider is not perceived to cheat users and will satisfy the commitments. kindness indicate that the service providers are expected to satisfy the requirements of their users positively. literature indicates that trust helps to build preference towards the adoption of a digital service and having higher trust on a system should also lead to higher usage satisfaction. hence we hypothesize h as follows. h : there is a positive relationship between trust and usage satisfaction information risk information risk plays an important factor in increasing the usage of digital services (mustafa et al. ) . digital payments services are required to maintain the integrity and authorization of transactions (slade et al. ) . reduced information risk instils higher user confidence because users lower their apprehension of losing their personal information and financial information to external entities intentionally or accidentally (leong et al. ) . information risk factors could be triggered by economical, performance, social, time or financial triggers (shon and swatman ; mustafa et al. ). if the information risk increases, as perceived by the consumer, there is a greater chance that the consumer may not adopt or use the technology (leong et al. ; slade et al. ; weerakkody et al. ). therefore we extend that argument that perceived information risk should have an adverse impact on the usage satisfaction of a digital service. as illustrated in fig. , we propose h as follows. h : there is a negative relationship between information risk and usage satisfaction security in this digital world, security plays a very important factor to maintain the relationship between merchant, users and with payments system (siau et al. ; mallat ) . security is one of the major concerns for customers. in mobile payments, users have their own private key or secret code for the online transaction it developed perceived security in mobile payments transactions. in these digital environments, it required to maintain mechanisms of authentication, authorization, non-repudiation between users, merchants and payments services (shon and swatman ) . perceptions surrounding security is often identified as one of the biggest challenges for all the users of digital services and smart technology products as they capture a lot of data and so digital identity systems are sometimes used to enable better security for such platforms (stadler ; mir et al. ). if users have concerns surrounding how others may access and use the information that is shared in a digital service, they tend to use it lesser (weerakkody et al. ) . we extend this argument that typically such user may be more dissatisfied from such service encounter. as illustrated in fig. , we propose h as follows. h : there is a positive relationship between security and usage satisfaction social influence social influence play a tremendous role while increasing the rate of adoption of consumer focused digital services including mobile based services (venkatesh et al. ; shin ). social groups can enable users create a perceived support system for trying new technologies, if the confidence of using the new technology is less. for mobile payment, social influence plays a dominant role in impacting intention to use and subsequently adoption (slade et al. ) . it can become even more critical, if there is a sudden intervention. interventions in india like demonetization also encouraged users to use mobile payments services for transactions suddenly. because of the sudden nature of such interventions, we hypothesized social influence to be a critical factor. further, even if one starts using such a service, we perceived it would also impact the experience associated with such usage, if there were support from social groups. greater the support while individuals were using it, better is the service usage experience. h : there is a positive relationship between social influence and usage satisfaction ease of use for any digital service, adoption is often impacted by ease of use of the service, as has been illustrated in adoption literature like tam. mobile payments services are easy to use therefore it should provide a positive attitude to usage satisfaction (guriting and oly ndubisi ) . if mobile payments service is easy to use then it will remove any kind of transaction errors and it is one of the important aspects of any online financial transactions (flavian et al. ) . literature indicates that despite the progress of different adoption literature, ease of use from tam remains one of the critical factors which drives technology usage (rana et al. ) . extending this argument that users who use a technology are likely to be having greater usage satisfaction, if the platform is easier to use as compared to other platform. therefore we propose h as follows. h : there is a positive relationship between ease of use and usage satisfaction performance performance is basically used to measure how customers feel after the use of mobile payments services, it helps to perform the transaction online anywhere and at any time, it also measures the risk, speed, authentication while performing an on-line transaction (venkatesh et al. ; gholami et al. ) . evidences on mobile payment adoption highlight that higher is the performance expectancy, greater is the behavioural intention to use the service (slade et al. ) . extending the argument to usage satisfaction, we felt from the inductive research that performance is a key factor which affects usage satisfaction. higher performance of the mobile application in terms of speed, authentication and network usage could have a positive impact in terms of customer's usage satisfaction. similarly factors like crashing while running, bugs in the application could have adverse impacts on the usage satisfaction. thus we propose h as follows. h : there is a positive relationship between performance and usage satisfaction credibility credibility of a service provider comes out of trust on the service provider that the organization will not attempt to do anything that will harm the interest of the different stakeholders. this is driven by the trust on the service provider. the trust that an individual may have on the service provider has positive impacts on the usage intention of a digital service (slade et al. ) . it also defines a behavioural intention to use an information system like mobile payments services (amin ) . extending the argument based on inductive evidences, we hypothesized that if the service provider has greater credibility, the usage satisfaction would be higher for a digital service like mobile payments (kapoor et al. ) . as illustrated in fig. , we propose h as follows. h : there is a positive relationship between credibility and usage satisfaction reliability reliability of services ensure that there is uniformity of expectations of the customer about the outcome of any service (parasuraman et al. ). it also determines that a firm has the potential of delivering the promised services dependably, repeatedly over a period of time. as users indulge in repeated usage of a technology enabled service through a mobile application, the ability of the application to demonstrate the same quality of outcome, through the exchange of financial payment between intended parties, becomes critical in establishing higher reliability. higher reliability enhances positive affect surrounding the service. as illustrated in fig. , we propose the following hypothesis. h : there is a positive relationship between reliability and usage satisfaction information privacy in digital services like mobile payments, collection and sharing of unauthorised information can have a significant impact on the perceived efficacy of the service (tsai et al. ; stewart and segars ) . such concerns surrounding information privacy entails the access of information residing in the system which is meant to be accessed by the mobile payment application. information privacy is related to access rights granted to the mobile application to access data in the mobile device like location data, messages, files on the memory, usage data and network usage data (albashrawi and motiwalla ). such privacy concerns could be related to access and use of sensitive personal information within or outside the boundary of the firm for unintended usage. if information privacy is protected, customers should be more satisfied about their service encounters. thus as illustrated in fig. , we propose h as follows. h : there is a positive relationship between information privacy and usage satisfaction responsiveness mobile payment users believed that when payments or transactions are done electronically, it responds faster to their need than any other traditional methods used for payments (lin ) . the same is expected in terms of resolution to problems encountered during a service experience. responsiveness may also influence the satisfaction of customer based on any online business transaction. higher the responsiveness of the system to the inputs provided by the user, lesser is the user's time and effort which is utilised to meet the objectives and more is likely to be his satisfaction from the service encounter. responsiveness also comes into play if an automated transaction does not fulfil intended consequences and required human intervention due to technical or process related problems. a quicker human intervention in such problems was perceived to impact usage satisfaction positively. as illustrated in fig. , we propose h as follows. h : there is a positive relationship between responsiveness and usage satisfaction customer attitude literature on customer attitudes indicate that users have a positive or negative intention to use a specific digital service which may also impact their service experience (arvidsson ) . literature indicates that for internet-based technologies, customer attitude has a dominant role to play in its adoption (dwivedi et al. ). attitude towards a service can be due to different reasons. for example, if the cost of these payment services is low, if it became ease to use, if it provides high security and privacy but the low risk then the only customer has a positive attitude towards these payments services (arvidsson ) . users attitude towards using any specific information technology and application are the important factors for determining whether individual use that system or not (yang ) . as illustrated in fig. , we propose h as follows. h : there is a positive relationship between customer attitude and usage satisfaction confidentiality confidentiality is defined as the preservation of information within intended usage and among intended stakeholders related at the time of transaction such an identity of users/merchant, credit card information or purchase of products or services (meharia ) . confidentiality inherently means that the information should be secured among the parties involved in the transaction (meharia ) . the intended usage of a payment application is to facilitate transactions between two interested parties. however the application may have multiple other access rights in the system. how the information is collected through these access rights and regarding the transaction information, and how subsequently such information may be analysed and shared with unintended parties governs the confidentiality of data usage. evidences in data and literature highlighted concerns surrounding how government may be monitoring transactions in mobile payments after demonetization for the purpose of taxation and governance (mohan and kar ) . if concerns surrounding confidentiality were high, we envisioned an adverse impact on usage satisfaction. as illustrated in fig. , we propose h as follows. h : there is a positive relationship between confidentiality and usage satisfaction assurance assurance adequately increases the user's trust and decrease the risk while achieving any online transaction (parasuraman et al. ) . higher assurance in an intangible service would indicate that the service consumption is communicated to the stakeholders involved effectively, thereby enhancing positive affects about the service encounter. a major concern highlighted in the data for new users that users involved in digital payments did not get a confirmation before the transaction is completed that the payment is being transferred to the right recipient (mohan and kar ) . if assurance is low, usage satisfaction was also adversely impacted. as illustrated in fig. , we propose h as follows: h : there is a positive relationship between assurance and usage satisfaction the entire theoretical model has been illustrated in fig. subsequently in this manuscript. colour coding has been done to demarcate the foundation literature though which the individual constructs are derived in this study. in this research, a mixed research methodology approach; combining both qualitative and quantitative methods; is used for analysing and measuring the factors that are derived in the indian context. mix research designs have better reliability while dealing with user generated content (oh et al. ; karami et al. ). the first phase of the study draws insights from social media analytics where algorithms can transform user generated content using approaches of descriptive analytics, content analytics and network analytics (rathore et al. ; grover et al. ; grover and kar ) . this output is transformed through a qualitative content analysis method in the second phase of data analysis. then in the third phase, the output of the second phase is analysed using inferential statistics like multiple regression analysis. across these stages, the research methodology combines text analysis using sentiment mining and topic modelling with content analysis methods of social science research, and then multivariate analysis using multiple regression analysis. these approaches of combining social media analytics and statistical validation of hypothesis have shown immense potential in recent times, but multi-variate analysis has not been attempted to explain a theoretical perspective on a domain. we attempt to follow the guidelines highlighted by berente et al. ( ) in their commentary towards building theory in information systems based on data driven approaches. for this study, data was collected from twitter by using python for over a period of months from october till june , by using the popular hashtags (top ) and @mention used for mobile payments services. these service provider are identified as the top mobile payment service provider based on data listed by the government of india in npci website. other service providers had specifically local coverage and did not have presence beyond three states. discussions on twitter surrounding mobile payment service providers of such as paytm, mobikwik, freecharge, oxygen wallet, npci_bhim, payumoney, phonepe, razorpay were extracted. when the official account of these service providers have been mentioned (@mentions), the data has been collected using the twitter api. using this api, at a particular point of time, twitter allows % of the discussions surrounding the searched keyword to be extracted. among these service providers, npci_bhim is a public service provider while the rest are private firms. while the original extracted tweets exceeded eight lakhs, a total of , tweets were identified after the cleaning process. literature highlights that many studies have been conducted with sample sizes of even a lakh tweets are sufficient for theory development based on user generated content (grover et al. a, b, c; aswani et al. ). in the cleaning process, the retweets and tweets which were not in english were removed as this would have been difficult for our analysis based on existing capabilities of natural language processing. further tweets which had only links or images and were having text less than five words were also removed in this tweet extraction process as they do not have significant information surrounding the usage experience which can be used for further analysis. further all tweets were removed which did not originate from an user where the user profile did not have an image and was less than days old, so as to ensure the profile is genuinely representing an user. the extracted data was cleaned to remove stop words, meaningless characters such as html tags, punctuation, numbers, emoticons are removed through stemming. stemming is a process where derivations of words are reduced and mapped to the base word so that uniformity of analysis can be achieved. by undertaking stemming, one attempts to reduce the inflectional variations of each word which may have been introduced by a very large number of users to a common base or root. typically when many users discuss about a theme, they tend to use different variation of the same word and these words needs to be mapped to the base stem word for better accuracy of analysis (grover et al. b) . it operates by truncating the prefix or suffix of the word found in large volumes of text, and map the core word to an existing dictionary. the entire process of cleaning the tweets and stemming was undertaken by using the python nltk package where a database of english dictionary is available for natural language processing. the tweets were analysed subsequently using topic modelling for tweet summarization. topic modelling encompasses in this study, latent dirichlet allocation or lda algorithm (blei et al. ) has been used for topic modelling as it provides a mechanism to control the number of words and topics whereby an analysis towards an empirical model can be developed (grover et al. a, b, c) . based on the topics which emerged, we went back to literature to identify factors which appear relevant from the topic models. there were topics of fifteen words each that were computed at this stage for further analysis. after the topic models were used to identify potential factors, we went back to the methodology of content analysis in consumer research (kassarjian ) . in the content analysis methodology, coders would look at a context of text and map scores to relevant themes obtained from grover et al. a, b, c) , however such a methodology has never been used for inferential statistics. a word can be a unit of measurement which can be mapped to a theme, which in our case was the identified construct. category reliability and inter-judge reliability was ensured by creating a three member research team whereby one was having a background of telecommunications research, another coder was having a background in linguistics and the third (author) had a background of information systems research (kassarjian ) . the members evaluated all the topic models and assigned scores on a likert scale to the fifteen factors. each of the topics could be assigned a score on factors which were identified from the literature (revisit table ). the coders agreed on scores whereby the difference of the mapping among the group of coders did not exceed beyond point on a point likert scale. the coders did not meet initial inter-judge reliability on decisions. in these decisions, the team went back to revisit the tweets based on a corpus wide word based search whereby after looking at the tweets, the scores were decided consensually after a discussion. after the topic modelling output was created, it was necessary to evaluate how the topics are interconnected with each other. a network diagram typically can enable a visualization between such topics which co-occur together based on text summarization. network science is typically used in social media analytics to find out connects among key entities like users and the entities are connected with each other through edges which are typically the strength of the ties (rathore et al. ) . the reviews of social media analytics in general and network analytics in particular indicate by doing this activity, it is possible to find out different attributes about the entities which are connected to each other like cluster information, community size, their community strength and many more (börner et al. ; barabási ) . the network analysis among the topics enabled us to revalidate the connect of our choice of factors which are used in inferential analysis. in this analysis, individual words within topics, after removing stopwords and completed, were treated as nodes while entity resolution stage, and their cooccurrences is treated as edges. after this stage we proceeded to evaluate the sentiment of these topics using polarity analysis. sentiment mining was done to identify the polarity of the topics based on natural language processing using a semantic approach (rathore et al. ) . sentiment analysis can be done on twitter using a variety of approaches to understand (chang and chen ) . in this study, the stanford corenlp toolkit was used for this scoring of sentiments in terms of polarity (manning et al. ) . twitter based studies attempting to infer theoretical meaning from user generated content has often used this package grover et al. a, b, c) . this model is adopted since this approach allows tokenization, have a very large semantic library and has reasonable high accuracy for analysis of english library (manning et al. ) . for each topic, a point sentiment score was computed using this methodology and then mapped with the outputs of the content analysis of the topic models. this was the matrix which was taken forward for the inferential analysis in the subsequent stage. the multivariate analysis undertaken was conducted with multiple regression analysis to bring out the relationships among the factors along with inferential impacts on the dependent variable, namely usage satisfaction, to validate the hypothesis proposed in the theoretical development stage. since the content analysis methodology had met high interjudge reliability and validity, the inferential analysis safely assumes that there are very low multi-collinearity effects, if any, with the data and thus multiple regression analysis is sufficient for inferential analysis (gefen et al. ) . the low scores of correlation analysis among the independent constructs validated this assumption. the flowchart of the sequence of activities undertaken for this analysis is illustrated for simplification in fig. . in this research, collected data were analysed to identify customer perception of mobile payments services using a mix of methods of social media analytics which emerge from computer science and inferential statistical analysis which has its roots in terms of applications in social science research. first we illustrate the results of the sentiment analysis (polarity analysis) of the tweets mentioning the service provider, individually and collectively. in general, it is seen, more tweets in such mentions are having a negative polarity, as has been illustrated in fig. . from fig. , it is evident from the polarity analysis of tweets that majority of the users mention a service provider only when they are somewhat dissatisfied with the service. a fig. word cloud of cleaned topics derived with lda after tweet summarization manual investigation of the tweets which are neutral indicated that these are mostly those which have no emotional words associated and mostly reflected news or informational content from blogs. alternatively, users have to be delighted in some way that was unexpected for them to mention a payment service provider in tweets. subsequently, we attempted to visualize the topics which were identified from the tweets by using a word cloud based method. the stop words which were identified were deleted in the topics which were computed. further the incomplete words in the topic models or words which had spelling mistakes were corrected before this analysis. in this approach, words which appear more frequently among the topics has a larger font size as compared to the words which have lesser frequency among the topics. from the wordcloud created from the topics derived through the lda algorithm, it is evident that a lot of focus is on words like mpay, payment, usage experience, epay, wallet, internet, problems, connectivity, trust and many others. however from the word cloud it is not possible to understand how these words or themes are connected with each other, which can be understood with a network diagram. subsequently, we attempted to develop the network diagram based on association among the words derived out of topic modelling. this network diagram could help us cluster the associated words together into closely occurring themes. the network diagram should validate the nature of constructs that was identified from existing literature from different theoretical models, based on the words co-occurring together in a cluster. the network diagram is illustrated in fig. , where classes are indicated with a colour, and each class indicates a concept that is captured by words co-occurring together in a topic derived from tweet summarization using lda. the network analysis highlighted there were themes, based on association among the words. such association can be defined by using constructs, if one attempts to look back into existing literature to find out possible names for the clusters. it is however possible that more than one cluster based on the association among words, may be used to represent a construct representing a concept which could be useful for explaining a theoretical model. finally, after completing the analysis of the topic association which emerged after tweet summarization and mapping the topics to the constructs from existing literature, we attempted to validate the model using multivariate statistics like multiple regression analysis. multiple regression analysis was done to identify which factors have a positive influence on mobile payments services. for this, we defined the fifteen hypotheses, and to test each of the hypotheses independently by considered pearson's chi-square column to identify p-value, only those hypotheses were accepted whose p-value is less than or equal to . . therefore, the hypothesis surrounding constructs such as cost, usefulness, trust, social-influence, credibility, tangibility, responsiveness was significantly associated with user's perception towards mobile payments service because the significance value of this hypothesis was less than . . therefore, hypothesis such as h , h , h , h , h , h , and h was accepted. however hypothesis such as information-risk (h ), security (h ), ease of use (h ), performance (h ), reliability (h ), customer-attitude (h ), confidentiality (h ), assurance (h ) were not accepted because the p-value of this relationship were greater than . . the result of the regression analysis is illustrated in table . the model summary is illustrated in table , was developed to identify the value of r which explains the explainability of the model. in this model, the value of r is . for the constructs usage satisfaction for mobile payments services in india which interprets that assurance, confidentiality, usefulness, trust, security, customer attitude, credibility, reliability, ease of use, cost, information privacy, performance, responsiveness, social-influence, and informationrisk variables can explain the variance towards predicting usage satisfaction to the extent of . %. the significance value of this model was . , therefore, this model is accepted. in table , an overview of the hypothesis which were validated and the results of the validation is illustrated. out of the constructs which were identified from the topic models, relationships were accepted. the relatively lower number of relationships being accepted could be due to the noise which typically is present in social media discussions. while topic modelling captures the variety of discussions, it also captures factors which demonstrate low occurrences among the tweets in general and topic models in particular. in this study, we attempted to identify factors that affect usage experience from service encounters in mobile payments. the study attempted to extend and connect different theories of technology adoption with service science and service quality literature to predict the usage satisfaction of mobile payment based on user generated content surrounding a specific service encounter. the validation was done using user generated content which was mined on the service provider in twitter. in this study, , tweets were mined using methods of social media analytics like topic modelling, sentiment mining and network analysis. then using content analysis method, the descriptive outputs were mapped objectively to key constructs identified from literature. this allowed us to propose the new theoretical model, namely dsusm. subsequently, multivariate analysis was undertaken to validate the proposed dsusm model. our first thematic contribution in the domain of digital services in general and mobile payments in particular addresses a gap in existing customer experience literature where for digital services, accessing customer experience at the point of service consumption or service encounter becomes difficult to measure (becker and jaakkola ) . this is where the dependent variable of our study, namely, usage satisfaction, addresses and highlights a novel way to operationalize this measure. in such a background, we attempt to discuss the individual findings of our study. the second thematic contribution is showcasing an approach within big data analytics driven research, whereby theory building in information systems can be attempted through a combination of computational and social research methodologies. such directions are often highlighted in existing editorials that studies in big data need to move away from the data towards theory building (berente et al. ; . within the domain contribution, our first finding (fig. ) indicates that a much larger corpus among the tweets which were obtained in this approach were having negative polarity, as compared to positive polarity. this finding could be triggered due to multiple reasons as per existing literature (jansen et al. ). often users do not share their experiences unless they are extremely delighted about a product or service which may have aspirational features. mobile payments would be used predominantly as a service to access a different product or service which may trigger aspirational emotions or delight. since mobile payments do not have too many aspirational features for most people, the service encounters of positive experiences did not trigger tweets on the positive encounters of the service. however, many users when they are dissatisfied often complain to the brand in the hope for a timely resolution for the complaint (sparks et al. ) . this leads to having higher number of tweets with slightly negative and negative polarity. further many tweets, which often do not have highly polarizing words, may be reflected as a neutral tweet, which is basically the methodological limitation of many algorithms for sentiment analysis (rathore et al. ). in the second finding (fig. ) , we had identified the major themes from the topic modelling using lda, which was undertaken for summarizing the core focus of the tweets. the wordcloud demonstrates the key topics which were discussed in such tweets. words which are available in the word cloud can easily be mapped to existing constructs in service science and adoption literature. however there was a need to group words so that thematically they can be grouped together based on usage among many customers. the network science outcome (fig. ) highlights which of the words co-occurred together in the topic models and it helped us to identify possible factors from existing literature. fifteen clusters were derived from this analysis, as indicated in the colour coding. then looking at the words in the cluster and reflecting upon existing literature, fifteen factors could be identified for developing the dsusm for further validation. the initial proposed model integrated technology adoption literature, extended technology adoption literature and service science literature. fifteen constructs were identified from the analysis of unstructured data for proposing the dsusm model. however our inferential analysis as illustrated in table indicates that in the context of mobile payments usage in india, seven factors like cost, usefulness, trust, social-influence, credibility, information privacy and responsiveness have higher impacts. subsequently, it was also identified that the remaining eight factors like information risk, security, ease of use, performance, reliability, customer-attitude, confidentiality and assurance have lower impacts. it is important to note that the sample who use social media are technically more savvy than new technology users. so while adoption and service quality literature highlights the importance of factors like ease of use, performance and reliability, they are not considered by the users as being important while estimating usage satisfaction. we have defined this and elaborated usage satisfaction a bit more in this context. in this context, it is important to note that despite all evidences of ease of use being extremely critical to adoption of new technology (rana et al. satisfaction of technologies that users frequently use. this difference in importance could be because the user groups are already very technology friendly and do not face challenges while using this technology. so factors which often have very high impact in the adoption of new technology has less relevance in the usage satisfaction of digital services once they are used frequently. the technology is also somewhat mature, and so reliability issues of the application crashing may be very less. further, the theories we have adopted is from is adoption and service quality literature. however it is important to note that our dependent variable, usage satisfaction, which we have attempted to measure using topic modelling and sentiment mining, is very different from both adoption literature and service quality literature. hence while a different exploration of research on usage as a dependent variable, may continue to have these factors being relevant, the usage experience is not being explained statistically through these parameters. these factors definitely have some importance, as has been brought out in our topic modelling, but statistically lower importance in explaining the variation of the dependent variable "usage satisfaction". recent literature has indicated that value of such mobile payment platforms are driven by self congruence and novelty but also faces threat from unintended consequences of usage of new technology (karjaluoto et al. ; gong et al. ) . our findings are complementing these findings that for users who are technology friendly, such challenges and theories of resistance are minimal in impacting usage satisfaction. the theoretical implications of our study are in two folds. first we make theoretical contribution in proposing a new model for measuring digital service usage satisfaction. further we also make a methodological contribution in which we present an approach to develop inferential theoretical models using social media data. mobile payments services are one of the convenient and effective methods for winning greater market share in this real environment (bohle et al. ). an initial look at the overview of large volumes of user generated content and then connecting it with adoption and service science literature indicates factors like cost advantage, usefulness, trust, information risk, security, social influence, ease of use, performance, credibility and information privacy could be relevant (slade et al. (slade et al. , kapoor et al. ; pachpande and kamble ; gong et al. ) . in this study we extend the understanding surrounding the use of mobile payment services and its impacts on the consumer in an emerging economy like india. existing literature on mobile payment usage in india indicates that facilitators like price benefit, network externalities, trust, and habit and barriers like lack of facilitating conditions, risk and operational constraints impact the use of mobile payments (pal et al. ) . further technology readiness and privacy concerns impact adoption of mobile payments in india. however, none of these studies attempted to explore the antecedents which impacts usage satisfaction among the users. in fact, it is interesting to know that, which customer experience during service encounter has been a widely explored topic, antecedents of usage satisfaction or customer experience in the digital context is yet to be explored in existing literature (becker and jaakkola ) . usage satisfaction has been identified in existing literature as being key towards impacting adoption and use of technology enabled services. our study highlight that among the digital literate population, factors like cost, usefulness, trust, social-influence, credibility, information privacy and responsiveness drive mobile payment service experiences and affect the usage satisfaction. these antecedents extend understanding surrounding established factors like responsiveness, price benefits and information security and privacy for engagement and customer satisfaction which are already identified in existing literature based on user generated content in social media (agnihotri et al. ; grover and kar ) . the impact of these constructs have never been explored in the context of satisfaction from any technology or technology enabled service usage. the proposed dsusm model is one of a kind, whereby we develop a relationship among these theoretical frameworks and connect technology adoption models, extended technology adoption models and service science literature for estimating usage satisfaction. since the individual constructs are well established, future research can also attempt to revalidate this model or its extension, in different cultural context, technological context or service context. figure illustrates the final model that was derived after validating the model with multiple regression analysis. in this study, we have taken the mixed research methodology approach by combining social media analytics with multivariate analysis to identify the salient factors for successful and effective implementation of mobile payments services in india. qualitative analysis is used to analyse the text data by performing content analysis, content analysis is used to perform sentiments analysis and topic modelling in the data that is collected from social media sites such as twitter (bhattacherjee ) . the approach of using content analysis method for converting topic models to factors which can be validated for an inferential theoretical model, has not been attempted in existing literature. since we used social media sites such as twitter for data collection instead of data collected from survey forms, therefore its approach presents a novelty in itself when applied to connect methodologies for theory building which are otherwise disconnected in existing literature (wang et al. ; buntain et al. ; grover et al. ). these methods have never been connected for validating inferential models based on user generated content, and this approach is another major contribution in this study. the need for integrating inferential model or statistical analysis with the output of social media analytics is highlighted in this study itself. the descriptive findings which typically are obtained from social media analytics through network science or text mining, while is very information rich, it also has a lot of noise. as indicated from the outcome of the topic models and community analysis among topic modelling words, fifteen constructs were identifiable very distinctly. however, the statistical analysis whereby we attempted to regress these constructs with the dependent variable (namely, usage satisfaction) indicated that seven factors are actually statistically significant. this indicates, while inferences directly from the visualization outputs may always not be very statistically significant, although the information may be relevant. thus, for better reliability of the theoretical model and propositions, it is necessary to convert all such visualization output of "big data" to a form where they can be statistically validated, to the extent possible. methodologically, this requires a methodological move away from the approach, many of the studies which use "big data" adopt for theorizing in social, political or industrial domains of management literature. such an approach which extends descriptive findings of social media analytics with statistical analysis is likely to enhance the internal and external validity of the research methodology and hence the generalizability of the findings. our study highlights that factors like cost, usefulness, trust, social-influence, credibility, information privacy and responsiveness drive mobile payment service experiences and affect the usage satisfaction. so in line with these findings, service providers in india should attempt to minimize the cost of transactions. this could be positively impacted by reducing any fee per transaction during such mobile payments between parties. higher cashbacks may also positively impact the factor like cost which has a positive impact on the usage satisfaction. further, the usefulness of these apps can be enhanced, if they serve not only as a payment platform, but their usefulness can be enhanced towards availing other related services. for example, if the platform can enable payments not only which are peer to peer, but also for bills and utilities like electricity, phone bills, credit card bills, gas bills, fee payment, road taxes, ticketing needs and other payments, it will enhance the usefulness of the mobile application extensively. a market research can be undertaken for identifying such related services. in this context, social media discussions may also be mined for establishing complementary needs based on users of other similar services (hall-phillips et al. ) . trust and credibility can be built by service providers through efforts made in branding, possibly through influencers with credence. to build trust, sharing evidences of audits from third parties who are trusted may be helpful. customers may have greater trust on the mobile payment service provider if frequently evidences of positive experiences and growth of "satisfied customer base" can be shared with customers. for example, after every transaction if customers are asked about the feedback or rating, and periodically, the service providers could share with the customer, how many of the service encounters were absolutely delightful. further, attempts may be made to frequently communicate when users share their data in transactions, that their information is not only secure, but it will not be shared without their explicit permission within or outside the firm, for any unintended usage. such communication on how the firm is respecting and withholding the privacy of the user can help a lot in driving usage satisfaction. also attempts may be made not to access information or seek access rights for which the mobile application may not have explicit connect. for example, a mobile application may not seek access rights to the camera, unless there is a face recognition component in the software for verifying the credentials of the user who is initiating the transaction. similarly, a mobile application may not need access to location data unless specific use cases require permissions for using location data for providing specific utility to the user of the service. feedback surrounding the efficacy of such implementations can also be sought in social media (grover and kar ) . last but not the least, if problems are faced by users and they complain, an instant acknowledgement that their complaint is registered and frequently updating them on the status of their complaint, can help to address concerns surrounding responsiveness of the service provider. further to impact responsiveness, the firms could enhance the speed at which complaints raised across channels surrounding failures of transactions are addressed through artificial intelligence driven technologies like chatbots whereby the platform helps first by getting the complaint recorded, second by communicating the time to be taken for the issue to be resolved and third ensuring the resolution as per promised timelines by defining a problem escalation workflow based on criticality. such chatbots may hugely impact the customer relationship management and impact positively the responsiveness perceived by the customer when any challenge is faced from the use of a digital payment platform. responsiveness in social media enhances overall customer satisfaction (agnihotri et al. ). this study has certain limitations, first, in this study, , tweets were collected in which we apply social media analytics and multi-variate analytics techniques. this sample is technology friendly and uses the internet extensively and thus less representative of users who may be using such digital payment platforms less frequently. so findings are likely to be based on user groups who are technology friendly and have high usage. second, this study was focused only on popular mobile payments services used in india. most of the findings and tweets were related to paytm and bhim. while sampling was attempted across studies, the usage behaviour across these platforms were heavily skewed. third, this study has not attempted to compare which mobile payments services were better in terms of usage satisfaction. future research could also focus on factors which affect the prioritization of service providers by users. fourth in this study we were taken only fifteen factors to identify the influence rate of the mobile payments services. the current study can be extended if the data collection methodology were to be enhanced by addressing some biases of users in terms of expressing their service encounters. this maybe done if a longer duration of data collection could have been undertaken and a longitudinal study been done with the data. methodologically, the approach which has been highlighted can be used in future studies for exploring validation of theoretical models based on user generated content. this would in particular be relevant if data driven inductive research is undertaken for contributing to the domain of information systems. such mixed method approaches which analyse data using multiple methodologies to provide complementary insights on why specific trends are revealed based on data have been promoted in editorials in information systems (berente et al. ; . such studies which adopt similar approaches may attempt to explore antecedents of use, adoption, impact or other behavioural further, only the social media content that was in english was capture for the current analysis. so future research could also look towards exploring more socio-cultural elements of service encounters and usage experiences in future studies. future research can also try to improve upon this approach methodologically by developing approaches whereby better measures for internal and external validity can be demonstrated. this research tries to explore the drivers of usage experience based on social media data of mobile payments service users on twitter. an inferential research model is proposed, namely, dsusm, and attempt to validate the model statistically using twitter data. the model development stage based on topics identified from text summarization of tweets highlights the relevance of factors like assurance, confidentiality, usefulness, trust, security, customer attitude, credibility, reliability, ease of use, cost, information privacy, performance, responsiveness, social-influence, and information risk. afterwards based on inferential analysis using regression; factors like cost, usefulness, trust, credibility, social-influence, information-privacy and responsiveness have been identified to have a significant influence on the adoption of mobile payments services. if these factors are addressed perfectly by the mobile payments service providers, then the adoption rate of mobile payments services is expected to increase automatically. this is the first study which identified factors relevant for increasing the usage satisfaction towards mobile payments services based on user generated content. social media: influencing customer satisfaction in b b sales the theory of planned behaviour attitude-behavior relations: a theoretical analysis and review of empirical research privacy and personalization in continued usage intention of mobile banking: an integrative perspective factors affecting the intentions of customers in malaysia to use mobile phone credit cards understanding collaborative tourism information searching to support online travel planning consumer attitudes on mobile payment servicesresults from a proof of concept test search engine marketing is not all gold: insights from twitter and seoclerks network science customer experience: fundamental premises and implications for research research commentarydata-driven computationally intensive theory development marketing meets web . , social media, and creative consumers: implications for international marketing strategy social science research: principles, methods, and practices latent dirichlet allocation electronic payment systems-strategic and technical issues network science. annual review of information science and technology model of adoption of technology in households: a baseline model test and extension incorporating household life cycle comparing social media and traditional surveys around the boston marathon bombing the moderating effect of customer perceived value on online shopping behaviour way too sentimental? a credible model for online reviews why do small and medium enterprises use social media marketing and what is the impact: empirical insights from india a survey of citizens' awareness and adoption of e-government initiatives, the 'government gateway': a united kingdom perspective review of technology adoption frameworks in mobile commerce mcommerce technology adoption: thematic and citation analysis of scholarly research during past, present and future of mobile payments research: a literature review perceived usefulness, perceived ease of use, and user acceptance of information technology consumer adoption and usage of broadband in bangladesh re-examining the unified theory of acceptance and use of technology (utaut): towards a revised theoretical model the role played by perceived usability, satisfaction and consumer trust on website loyalty structural equation modeling and regression: guidelines for research practice factors affecting epayment adoption in nigeria transition from web to mobile payment services: the triple effects of status quo inertia user engagement for mobile payment service providers-introducing the social media engagement model technology-enabled health"-insights from twitter analytics with a socio-technical perspective understanding nature of social media usage by mobile wallets service providers-an exploration through spin framework perceived usefulness, ease of use and user acceptance of blockchain technology for digital transactions-insights from user-generated content on twitter polarization and acculturation in us election outcomes-can twitter analytics predict changes in voting preferences impact of corporate social responsibility on reputation-insights from tweets on sustainable development goals by ceos the perils and promises of big data research in information systems borneo online banking: evaluating customer perceptions and behavioural intention i (heart) social ventures: identification and social media engagement silences of ethical practice: dilemmas for researchers using social media understanding the adoption of multipurpose information appliances: the case of mobile data services managing your social campaign strategy using facebook, twitter, instagram, youtube & pinterest: an interview with dana howard, social media marketing manager the effect of electronic word of mouth communications on intention to buy: a meta-analysis twitter power: tweets as electronic word of mouth a model for prioritization and prediction of impact of digital literacy training programmes and validation the key determinants of internet banking service quality: a content analysis innovation adoption attributes: a review and synthesis of research findings advances in social media research: past, present and future twitter and research: a systematic literature review through text mining how perceived value drives the use of mobile financial services apps mobile payment: a journey through existing procedures and standardization initiatives content analysis in consumer research the effect of perceived service quality dimensions on customer satisfaction, trust, and loyalty in ecommerce settings: a cross-cultural analysis do social media marketing activities enhance customer equity? an empirical study of luxury fashion brand enjoyment and social influence: predicting mobile payment adoption australian marketing managers' perceptions of the internet: a quasi-longitudinal perspective an empirical study on consumer acceptance of products in electronic markets: a transaction cost model factors influencing satisfaction and loyalty in online shopping: an integrated model determining the relative importance of mobile banking quality factors webqual: an instrument for consumer evaluation of web sites exploring consumer adoption of mobile payments-a qualitative study social media: the new hybrid element of the promotion mix the stanford corenlp natural language processing toolkit assurance on the reliability of the mobile payment system and its effects on its use: an empirical examination. accounting and management information systems realizing digital identity in government: prioritizing design and implementation objectives for aadhaar in india november). #demonetization and its impact on the indian economy-insights from social media analytics digital literacy training, impact & moderating role of perceived value among unemployed women in india understanding the impact of digital service failure on users: integrating tan's failure and delone and mclean's success model use of social media in health promotion: purposes, key performance indicators, and evaluation metrics role of social media in social change: an analysis of collective sense making during the egypt revolution conceptual issues in the structural analysis of consumption emotion, satisfaction, and quality: evidence in a service setting m-pesa: progress and prospects study of e-wallet awareness and its usage in mumbai contextual facilitators and barriers influencing the continued use of mobile payment services in a developing country: insights from adopters in india. information technology for development business performance and social media: love or hate? factors affecting the usage of payment services through digital television in italy understanding customer expectations of service servqual: a multiple-item scale for measuring consumer perception of service quality paycash: a secure efficient internet payment system fintech. business & information systems engineering evaluating alternative theoretical models for examining citizen centric adoption of e-government citizens' adoption of an electronic government system: towards a unified view pre-and post-launch emotions in new product development: insights from twitter analytics of three products social media analytics: literature review and directions for future research diffusion of innovations a conceptual model of trust in the online environment e-tailer website attributes and trust: understanding the role of online reviews determinants of user behavior intention (bi) on mobile services: a preliminary view towards an understanding of the consumer acceptance of mobile wallet identifying effectiveness criteria for internet payment systems modeling consumers' adoption intentions of remote mobile payments in the united kingdom: extending utaut with innovativeness, risk, and trust devising a research model to examine adoption of mobile payments: an extension of utaut extending utaut to explore consumer adoption of mobile payments a survey of online e-banking retail initiatives responding to negative online reviews: the effects of hotel responses on customer inferences of trust and concern an empirical examination of the concern for information privacy instrument consumer acceptance and use of information technology: a meta-analytic evaluation of utaut investigation of electronic-word-ofmouth on online social networking sites written by authors with commercial interest the perception of e-servicescape and its influence on perceived e-shopping value and customer loyalty factors affecting consumers' perception of electronic payment: an empirical analysis enhancing promotional strategies within social marketing programs: use of web . social media effects of word-ofmouth versus traditional marketing: findings from an internet social networking site the effect of online privacy information on purchasing behavior: an experimental study technology acceptance model and a research agenda on interventions a theoretical extension of the technology acceptance model: four longitudinal field studies computer technology training in the workplace: a longitudinal investigation of the effect of mood. organizational behaviour and human decision processes user acceptance of information technology: toward a unified view consumer acceptance and use of information technology: extending the unified theory of acceptance and use of technology determinants of user acceptance of internet banking: an empirical study comparing social media data and survey data in assessing the attractiveness of beijing olympic forest park open data and its usability: an empirical view from the citizen's perspective a theoretical integration of user satisfaction and technology acceptance exploring factors affecting the adoption of mobile commerce in singapore a proposed model of e-trust for electronic banking electronic payment systems: an analysis and comparison of types building brand loyalty through user engagement in online brand communities in social networking sites examining the critical success factors of mobile website adoption it-based services and service quality in consumer banking publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- -tpqsjjet authors: nan title: section ii: poster sessions date: - - journal: j urban health doi: . /jurban/jti sha: doc_id: cord_uid: tpqsjjet nan food and nutrition programs in large urban areas have not traditionally followed a systems approach towards mitigating food related health issues, and instead have relied upon specific issue interventions char deal with downstream indicators of illness and disease. in june of , the san francisco food alliance, a group of city agencies, community based organizations and residents, initiated a collahorarive indicator project called rhe san francisco food and agriculture assessment. in order to attend to root causes of food related illnesses and diseases, the purpose of the assessment is to provide a holistic, systemic view of san francisco\'s food system with a focus on three main areas that have a profound affect on urban public health: food assistance, urban agriculture, and food retailing. using participatory, consensus methods, the san francisco food alliance jointly developed a sec of indicators to assess the state of the local food system and co set benchmarks for future analysis. members collected data from various city and stare departments as well as community based organizations. through the use of geographic information systems software, a series of maps were created to illustrate the assets and limitations within the food system in different neighborhoods and throughout the city as a whole. this participatory assessment process illustrates how to more effectively attend to structural food systems issues in large urban areas by ( t) focusing on prevention rather than crisis management, ( ) emphasizing collaboration to ensure institutional and structural changes, and ( ) aptly translating data into meaningful community driven prevention activities. to ~xplore the strategies to overcome barriers to population sample, we examined the data from three rapid surveys conducted at los angeles county (lac). the surveys were community-based partic· patory surveys utilizing a modified two-stage cluster survey method. the field modifications of the method resulted in better design effect than conventional cluster sample survey (design effect dose to that if the survey was done as simple random sample survey of the same size). the surveys were con· ducte~ among parents of hispanic and african american children in lac. geographic area was selected and d .v ded int.o small c~usters. in the first stage, clusters were selected with probability proportionate to estimated size of children from the census data. these clusters were enumerated to identify and develop a list of households with eligible children from where a random sample was withdrawn. data collectmn for consented respondents involved - minutes in-home interview and abstraction of infor· ma~ion from vaccine record card. the survey staff had implemented community outreach activities designed to fost~r an~ maintain community trust and cooperation. the successful strategies included: developing re.lat on .w. th local community organizations; recruitment of community personnel and pro· vide them with training to conduct the enumeration and interview; teaming the trained community introduction: though much research has been done on the health and social benefits of pet ownership for many groups, there have been no explorations of what pet ownership can mean to adults who are marginalized, living on fixed incomes or on the street in canada. we are a community group of researchers from downtown toronto. made up of front line staff and community members, we believe that community research is important so that our concerns, visions, views and values are presented by us. we also believe that research can and should lead to social change. method: using qualitative and exploratory methods, we have investigated how pet ownership enriched and challenged the lives of homeless and transitionally housed people. our research team photographed and conducted one-on-one interviews with pet owners who have experienced home· lessncss and live on fixed incomes. we had community participation in the research through a partnership with the fred vicror centre camera club. many of the fred victor centre camera club members have experienced homelessness and being marginalized because of poverty. the members of the dub took the photos and assisted in developing the photos. they also participated in the presenta· tion of our project. results: we found that pet ownership brings important health and social benefits to our partici· pants. in one of the most poignant statements, one participant said that pet ownership " ... stops you from being invisible." another commented that "well, he taught me to slow down, cut down the heavy drugs .. " we also found that pet ownership brings challenges that can at times be difficult when one is liv· ing on a fixed income. we found that the most difficult thing for most of the pet owners was finding affordable vet care for their animals. conclusion: as a group, we decided that research should only be done if we try to make some cha.nges about what we have learned. we continue the project through exploring means of affecting social change--for example, ~eti.tions and informing others about the result of our project. we would like to present our ~mdmgs and experience with community-based participatory action resea.rch m an oral. presentarton at yo~r conference in october. our presentation will include com· mumty representation ~f. both front-hne staff and people with lived experience of marginalization and homdessness. if this is not accepted as an oral presentation, we are willing to present the project m poster format. introduction the concept of a healthy city was adopted by the world health organization some time ago and it includes strong support for local involvement in problem solving and implementation of solutions. while aimed at improving social, economic or environmental conditions in a given community, more significantly the process is considered to be a building block for poliq reform and larger scale 'hange, i.e. "acting locally while thinking globally." neighbourhood planning can he the entry point for citizens to hegin engaging with neighbours on issues of the greater common good. methods: this presentation will outline how two community driven projects have unfolded to address air pollution. the first was an uphill push to create bike lanes where car lanes previously existed and the second is an ongoing, multi-sectoral round table focused on pollution and planning. both dt•monstrate the importance of having support with the process and a health focus. borrowing from traditions of "technical aid"• and community development the health promoter /planner has incorporated a range of "determinants of health" into neighbourhood planning discussions. as in most urban conditions the physical environment is linked to a range of health stressors such as social isolation, crowding, noise, lack of open space /recreation, mobility and safety. however typical planning processes do not hring in a health perspective. health as a focus for neighbourhood planning is a powerful starti_ng point when discussing transportation planning or changing land-uses. by raising awareness on determmants of health, citizens can begin to better understand how to engage in a process and affect change. often local level politics are involved and citizens witness policy change in action. the environmental liaison committee and the dundas east hike lanes project resulted from local level initiatives aimed at finding solutions to air pollution -a priority identified hy the community. srchc supported the process with facilitation and technical aid. _the processs had tangible results that ultimately improve living conditions and health. •tn the united kmgdom plannm in the 's established "technical aid" offices much like our present day legal aid system to provide professional support and advocacy for communities undergoing change. p - (c) integrating community based research: the experience of street health, a community service agency i.aura cowan and jacqueline wood street health began offering services to homeless men and women in east downtown ~oronto in . nursing stations at drop-in centres and shelters were fo~lowed by hiv/aids prevent ~, harm reduction and mental health outreach, hepatitis c support, sleeping bag exchange, and personal tdennfication replacement and storage programs. as street health's progi;ams expanded, so to~ did the agency:s recognition that more nee~ed t~ be done to. address the underl~ing causes of, th~ soct~l and economic exclusion experienced by its clients. knowing t.h~t. a~voca~y ts. helped by . evtd~nce , street he.alt~ embarked on a community-based research (cbr) initiative to dent fy commumty-dnven research priorities within the homeless and underhoused population. methods: five focus groups were conducted with homeless people, asking participants to identify positive and negative forces in their lives, and which topics were important to take action on and learn more about. findings were validated through a validation meeting with participants. results: participants identified several important positive and negative forces in their lives. key positive forces included caring and respectful service delivery, hopefulness and peer networks. key negative forces included lack of access to adequate housing and income security, poor service delivery and negative perceptions of homeless people. five topics for future research emerged from the process, focusing on funding to address homelessness and housing; use of community services for homeless people; the daily survival needs of homeless people and barriers to transitioning out of homelessness; new approaches to service delivery that foster empowerment; and policy makers' understanding of poverty and homelessness. conclusions: although participants expressed numerous issues and provided much valuable insight, definitive research ideas and action areas were not clearly identified by participants. however, engagement in a cbr process led to some important lessons and benefits for street health. we learned that the community involvement of homeless people and front-line staff is critical to ensuring relevance and validity for a research project; that existing strong relationships with community parmers are essential to the successful implementation of a project involving marginalized groups; and that an action approach focusing on positive change can make research relevant to directly affected people and community agency staff. street health benefited from using a cbr approach, as the research process facilitated capacity building among staff and within the organization as a whole. p - (c) a collaborative process to achieve access to primary health care for black women and women of colour: a model of community based participartory research notisha massaquoi, charmaine williams, amoaba gooden, and tulika agerwal in the current healthcare environment, a significant number of black women and women of color face barriers to accessing effective, high quality services. research has identified several issues that contribute to decreased access to primary health care for this population however racism has emerged as an overarching determinant of health and healthcare access. this is further amplified by simultaneous membership in multiple groups that experience discrimination and barriers to healthcare for example those affected by sexism, homelessness, poverty, homophobia and heterosexism, disability and hiv infection. the collaborative process to achieve access to primary health care for black women and women of colour project was developed with the university of toronto faculty of social work and five community partners using a collaborative methodology to address a pressing need within the community ro increase access to primary health care for black women and women of colour. women's health in women's hands community health centre, sistering, parkdale community health centre, rexdale community health centre and planed parenthood of toronto developed this community-based participatory-action research project to collaboratively barriers affecting these women, and to develop a model of care that will increase their access to health services. this framework was developed using a process which ensured that community members from the target population and service providers working in multiculrural clinical settings, were a part of the research process. they were given the opportunity to shape the course of action, from the design of the project to the evaluation and dissemination phase. empowerment is a goal of the participatory action process, therefore, the research process has deliberately prioritized _ro enabling women to increase control over their health and well-being. in this session, the presenters will explore community-based participatory research and how such a model can be useful for understanding and contextualizing the experiences of black women and women of colour. they will address. the development and use of community parmerships, design and implementation of the research prorect, challenges encountered, lessons learnt and action outcomes. they will examine how the results from a collaborative community-based research project can be used as an action strategy to poster sessions v address che social determinants of women health. finally the session will provide tools for service providers and researchers to explore ways to increase partnerships and to integrate strategies to meet the needs of che target population who face multiple barriers to accessing services. lynn scruby and rachel rapaport beck the purpose of this project was ro bring traditionally disenfranchised winnipeg and surrounding area women into decision-making roles. the researchers have built upon the relationships and information gachered from a pilot project and enhanced the role of input from participants on their policy prioriries. the project is guided by an advisory committee consisting of program providers and community representatives, as well as the researchers. participants included program users at four family resource cencres, two in winnipeg and two located rurally, where they participated in focus groups. the participants answered a series of questions relating to their contact with government services and then provided inpuc as to their perceptions for needed changes within government policy. following data analysis, the researchers will return to the four centres to share the information and continue che discussion on methods for advocating for change. recommendations for program planning and policy development and implementation will be discussed and have relevance to all participants in the research program. women's health vera lefranc, louise hara, denise darrell, sonya boyce, and colleen reid women's experiences with paid and unpaid work, and with the formal and informal economies, have shifted over the last years. in british columbia, women's employability is affected by government legislation, federal and provincial policy changes, and local practices. two years ago we formed the coalition ior women's economic advancement to explore ways of dealing with women's worsening economic situations. since the formation of the coalition we have discussed the need for research into women's employabilicy and how women were coping and surviving. we also identified how the need to document the nature of women's employability and reliance on the informal economy bore significanc mechodological and ethical challenges. inherent in our approach is a social model of women's health that recognizes health as containing social, economic, and environmental determinants. we aim to examine the social contexc of women's healch by exploring and legitimizing women's own experiences, challenging medical dominance in understandings of health, and explaining women's health in terms of their subordination and marginalizacion. through using a feminist action research (far) methodology we will explore the relationship between women's employability and health in communities that represent bricish columbia's social, economic, cultural/ethnic, and geographic diversities: skidegate, fort st . .john, lumhy, and surrey. over the course of our year project, in each community we will establish and work with advisory committees, hire and train local researchers, conduct far (including a range of qualitative methods), and support action and advocacy. since the selected communities are diverse, the ways that the research unfolds will ·ary between communities. expected outcomes, such as the provision of a written report and resources, the establishment of a website for networking among the communities, and a video do.:umentary, are aimed at supporting the research participants, coalition members, and advisory conuniuces in their action efforts. p t (c) health & housing: assessing the impact of transitional housing for people living with hiv i aids currently, there is a dearth of available literature which examines supporrive housing for phas in the canadian context. using qualitative, one-on-one interviews we investigace the impact of transitional housing for phaswho have lived in the up to nine month long hastings program. our post<'r pr<·senta-t on will highlight research findings, as well as an examination of transitional housing and th<· imp;kt it has on the everyday lives of phas in canada. this research is one of two ground breaking undertakings within the province of ontario in which fife house is involved. p - (c) eating our way to justice: widening grassroots approaches to food security, the stop community food centre as a working model charles l.evkoe food hanks in north america have come co play a central role as the widespread response to growing rates of hunger. originally thought to be a short term-solution, over the last years, they have v poster sessions be · · · · d wi'thi'n society by filling the gaps in the social safety net while relieving govemcome mst tut ona ze . . . t f the ir responsibilities. dependent on corporate donations and sngmauzmg to users, food banks men so th' . · i i . are incapable of addressing the structural cause~ of ~u~ger. s pres~ntation w e~~ ore a ternanve approaches to addressing urban food security while bmldmg more sustamabl.e c~mmumt es. i:nrough the f t h st p community food centre, a toronto-based grassroots orgamzanon, a model is presented case e h'l k' b 'id · b that both responds to the emergency food needs of communities w e wor mg to. u ~ sustama le and just food system. termed, the community food centre model. (cfc), ~he s~op is worki?g to widen its approach to issues of food insecurity by combining respectful ~ rect service wit~ com~~mty ~evelop ment, social justice and environmental sustainability. through this approach, various critical discourses around hunger converge with different strategic and varied implications for a~ion. as a plac~-based organization, the stop is rooted within a geographical space and connected directly to a neighbourhood. through working to increase access to healthy food, it is active in maintaining people's dignity, building a strong and democratic community and educating for social change. connected to coalitions and alliances, the stop is also active in organizing across scales in connection with the global food justice movement. inner city shelter vicky stergiopoulos, carolyn dewa, katherine rouleau, shawn yoder, and lorne tugg introduction: in the city of toronto there are more than , hostel users each year, many with mental health and addiction issues. although shelters have responded in various ways to the health needs of their clients, evidence on the effectiveness of programs delivering mental health services to the home· less in canada has been scant. the objective of this community based research was to provide a forma· tive evaluation of a multi-agency collaborative care team providing comprehensive care for high needs clients at toronto's largest shelter for homeless men. methods: a logic model provided the framework for analysis. a chart review of clients referred over a nine month period was completed. demographic data were collected, and process and outcome indicators were identified for which data was obtained and analyzed. the two main outcome measures were mental status and housing status months after referral to the program. improvement or lack of improvement in mental status was established by chart review and team consensus. housing outcomes were determined by chart review and the hostel databases. results: of the clients referred % were single and % were unemployed. forty four percent had a psychiatric hospitalization within the previous two years. the prevalence of severe and persistent men· tal illness, alcohol and substance use disorders were %, % and % respectively. six months after referral to the program % of clients had improved mental status and % were housed. logistic regression controlling for the number of general practitioner and psychiatrist visits, presence of person· ality or substance use disorder and treatment non adherence identified two variables significantly associ· ated mental status improvement: the number of psychiatric visits (or, . ; % ci, . - . ) and treatment non adherence (or, . ; % ci, . - . ). the same two variables were associated with housing outcomes. history of forensic involvement, the presence of a personality or substance use disorder and the number of visits with a family physician were not significantly associated with either outcome. conclusions: despite the limitations in sample sire and study design, this study can yield useful informa· tion to program planners. our results suggest that strategies to improve treatment adherence and access to mental health specialists can improve outcomes for this population. although within primary care teams the appropriate collaborative care model for this population remains to be established, access to psychiatric follow up, in addition to psychiatric assessment services, may be an important component of a successful program. mount sinai hospital (msh) has become one of the pre-eminent hospitals in the world by contributing to the development of innovative approaches to effective health care and disease prevention. recently, the hospital has dedicated resources towards the development of a strategy aimed at enhancing the hospital's integration with its community partners. this approach will better serve the hospital in the current health care environment where local health integration networks have been struck to enhance and support local capacity to plan, coordinate and integrate service delivery. msh has had early success with developing partnerships. these alliances have been linked to programs serving key target populations with _estabhshe~. points of access to msh. recognizing the need to build upon these achievements to remain compe~mve, the hospital has developed a community integration strategy. at the forefront of this strategy is c.a.r.e (community advisory reference engine): the hospital's compendium of poster sessions v community partners. as a single point of access to community partner information, c.a.r.e. is more than a database. c.a.r.e. serves as the foundation for community-focused forecasting and a vehicle for inter and intra-organizational knowledge transfer. information gleaned from the catalog of community parmers can be used to prepare strategic, long-term partnership plans aimed at ensuring that a comprehensive array of services can be provided to the hospital community. c.a.r.e. also houses a permanent record of the hospital's alliances. this prevents administrative duplication and facilitates the formation of new alliances that best serve both the patient and the hospital. c.a.r.e. is not a stand-alone tool and is most powerful when combined with other aspects of the hospital's community integration strategy. it iscxpected that data from the hospital's community advisory committees and performance measurement department will also be stored alongside stakeholder details. this information can then be used to drive discussions at senior management and the board, ensuring congruence between stakeholder, patient and hospital objectives. the patient stands to benefit from this strategy. the unique, distinct point of reference to a wide array of community services provides case managers and discharge planners with the information they need to connect patients with appropriate community services. creating these linkages enhances the patient's capacity to convalesce in their homes or places of residence and fosters long-term connections to neighborhood supports. these connections can be used to assist with identifying patients' ongoing health care needs and potentially prevent readmission to hospital. introduction: recruiting high-risk drug users and sex workers for hiv-prevention research has often been hampered by limited access to hard to reach, socially stigmatized individuals. our recruitment effom have deployed ethnographic methodology to identify and target risk pockets. in particular, ethnographers have modeled their research on a street-outreach model, walking around with hiv-prevention materials and engaging in informal and structured conversations with local residents, and service providers, as well as self-identified drug users and sex workers. while such a methodology identifies people who feel comfortable engaging with outreach workers, it risks missing key connections with those who occupy the margins of even this marginal culture. methods: ethnographers formed a women's laundry group at a laundromat that had a central role as community switchboard and had previously functioned as a party location for the target population. the new manager helped the ethnographers invite women at high risk for hiv back into the space, this time as customers. during weekly laundry sessions, women initiated discussions about hiv-prevention, sexual health, and eventually, the vaccine research for which the center would be recruiting women. ra.its: the benefits of the group included reintroducing women to a familiar locale, this time as customers rather than unwelcome intruders; creating a span of time (wash and dry) to discuss issues important to me women and to gather data for future recruitment efforts; creating a location to meet women encountered during more traditional outreach research; establishing the site as a place for potential retention efforts; and supporting a local business. women who participated in the group completed a necessary household task while learning information that they could then bring back to the community, empowering them to be experts on hiv-prevention and vaccine research. some of these women now assist recruitment efforts. the challenges included keeping the group women-only, especially after lunch was provided, keeping the membership of the group focused on women at risk for hiv, and keeping the women in the group while they did their laundry. conclusion: public health educators and researchers can benefit from identifying alternate congregation sites within risk pockets to provide a comfortable space to discuss hiv prevention issues with high-risk community members. in our presentation, we will describe the context necessary for similar research, document the method's pitfalls and successes, and argue that the laundry group constitutes an ethical, respectful, community-based method for recruitment in an hiv-prevention vaccine trial. p - t (c) upgrading inner city infrastructure and services for improved environmental hygiene and health: a case of mirzapur in u.p. india madhusree mazumdar in urgency for agricultural and industrial progress to promote economic d.evelopment follo_wing independence, the government of india had neglected health promotion and given less emphasis on infrastructure to promote public health for enhanced human pro uct v_ity. ong wit r~p m astrucrure development, which has become essential if citie~ are to. act ~s harbmger.s of econ~nuc ~owth, especially after the adoption of the economic liberalization policy, importance _is a_lso ~emg g ve.n to foster environmental hygiene for preventive healthcare. the world health orga~ sat ~ is also trj:' ! g to help the government to build a lobby at the local level for the purpose by off~rmg to mrroduce_ its heal.thy city concept to improve public health conditions, so as to reduce th_e disease burden. this pape~ s a report of the efforts being made towards such a goal: the paper descr~bes ~ c~se study ?f ~ small city of india called mirzapur, located on the banks of the nver ganga, a ma or lifeline of india, m the eastern part of the state of uttar pradesh, where action for improvement began by building better sanitation and environmental infrastructure as per the ganga action plan, but continued with an effort to promote pre· ventive healthcare for overall social development through community participation in and around the city. asthma physician visits in toronto, canada tara burra, rahim moineddin, mohammad agha, and richard glazier introduction: air pollution and socio-economic status are both known to be associated with asthma in concentrated urban settings but little is known about the relationship between these factors. this study investigates socio-economic variation in ambulatory physician consultations for asthma and assesses possible effect modification of socio-economic status on the association between physician visits and ambient air pollution levels for children aged to and adults aged to in toronto, canada between and . methods: generalized additive models were used to estimate the adjusted relative risk of asthma physician visits associated with an interquartile range increase in sulphur dioxide, nitrogen dioxide, pm . , and ozone, respectively. results: a consistent socio-economic gradient in the number of physician visits was observed among children and adults and both sexes. positive associations between ambient concentrations of sul· phur dioxide, nitrogen dioxide and pm . and physician visits were observed across age and sex strata, whereas the associations with ozone were negative. the relative risk estimates for the low socio-«onomic group were not significantly greater than those for the high socio-economic group. conclusions: these findings suggest that increased ambulatory physician visits represent another component of the public health impact of exposure to urban air pollution. further, these results did not identify an age, sex, or socio-economic subgroup in which the association between physician visits and air pollution was significantly stronger than in any other population subgroup. eco-life-center (ela) in albania supports a holistic approach to justice, recognizing the environ· mental justice, social justice and economic justice depend upon and support each other. low income cit· izens and minorities suffer disproportionately from environmental hazards in the workplace, at home, and in their communities. inadequate laws, lax enforcement of existing environmental regulations, and ~ea.k penalties for infractions undermine environmental protection. in the last decade, the environmental ust ce m~ve~ent in tirana metropolis has provided a framework for identifying and exposing the links ~tween irrational development practices, disproportionate siting of toxic facilities, economic depres· s on, and a diminished quality of life in low-income communities and communities of color. the envi· ~onmental justice agenda has always been rooted in economic, racial, and social justice. tirana and the issues su.rroun~ing brow~fields redevelopment are crucial points of advocacy and activism for creating ~ubstantia~ social chan~~ m low-income communities and communities of color. we engaging intensively m prevcnnng co'.' mumnes, especially low income or minority communities, from being coerced by gov· ernmenta~ age_nc es or companies into siting hazardous materials, or accepting environmentally hazard· ous_ practices m order to create jobs. although environmental regulations do now exist to address the environmental, health, and social impacts of undesirable land uses, these regulations are difficult to poster sessions v enforce because many of these sites have been toxic-ridden for many years and investigation and cleanup of these sites can be expensive. removing health risks must be the main priority of all brown fields action plans. environmental health hazards are disproportionately concentrated in low-income communities of color. policy requirements and enforcement mechanisms to safeguard environmental health should be strengthened for all brownfields projects located in these communities. if sites are potentially endangering the health of the community, all efforts should be made for site remediation to be carried out to the highest cleanup standards possible towards the removal of this risk. the assurance of the health of the community should take precedence over any other benefits, economic or otherwise, expected to result from brownfields redevelopment. it's important to require from companies to observe a "good neighbor" policy that includes on-site visitations by a community watchdog committee, and the appointment of a neighborhood environmentalist to their board of directors in accordance with the environmental principles. vancouver - michael buzzelli, jason su, and nhu le this is the second paper of research programme concerned with the geographical patterning of environmental and population health at the urban neighbourhood scale. based on the vancouver metropolitan region, the aim is to better understand the role of neighbourhoods as epidemiological spaces where environmental and social characteristics combine as health processes and outcomes at the community and individual levels. this paper builds a cohort of commensurate neighbourhoods across all six censuses periods from to , assembles neighbourhood air pollution data (several criterion/health effects pollutants), and providing an analysis to demonstrate how air pollution systematically and consistently maps onto neighbourhood socioeconomic markers, in this case low education and lone-parent families. we conclude with a discussion of how the neighbourhood cohort can be further developed to address emergent priorities in the population and environmental health literatures, namely the need for temporally matched data, a lifecourse approach, and analyses that control for spatial scale effects. solid waste management and environment in mumbai (india) by uttam jakoji sonkamble and bairam paswan abstract: mumbi is the individual financial capital of india. the population of greater mumbai is , , and sq. km. area. the density of population , per sq. km. the dayto-day administration and rendering of public services within gr. mumbai is provided by the brihan mumbai mahanagar palika (mumbai corporation of gr. mumbai) that is a body of elected councilors on a -year team. mumcial corporation provides varies conservancy services such as street sweeping, collection of solid waste, removal and transportation, disposal of solid waste, disposal of dead bodies of animals, construction, maintance and cleaning of urinals and public sanitary conveniences. the solid waste becoming complicated due to increase in unplanned urbanization and industrialization, the environment has deteriorated significantly due to inter, intra and international migration stream to mumbai. the volume of inter state migration to mumbai is considerably high i.e. . lakh and international migrant . lakh have migrated to mumbai. present paper gives the view on solid waste management and its implications to environment and health. pollution from a wide varity of emission, such as from automobiles and industrial activities, has reached critical level in mumbai, causing respiratory, ocular, water born diseases and other health problems. sources of generation of waste are -household waste, commercial waste, institutional waste, street sweeping, silt removed from drain/nallah/cleanings. disposal of solid waste in gr. mumbai done under incineration . processing to produce organic manure. . vermi-composting . landfill the study shows that the quantity of waste disposal of through processing and conversion to organic ~anure is about - m.t. per day. the processing is done by a private agency m/s excel industries ltd. who had set up a plant at the chincholi dumping ground in western mumbai for this purpose. the corporation is also disposal a plant of its waste mainly market waste through the environment friendly, natural pro-ces~ known as vermi-composing about m.t. of market waste is disposed of in this manner at the various sites. there are four land fill sites are available and percent of the waste matter generated m mumbai is disposed of through landfill. continuous flow of migrant and increa~e in slum population is a complex barrier in the solid waste management whenever community pamc pat on work strongly than only we can achieved eco-friendly environment in mumbai. persons exposed to residential craffic have elevated races of respiratory morbidity an~ ~ortality. since poverty is an important determinant of ill-health, some h~ve argued that t~es~ assoc at ons may relate to che lower socioeconomic status of those living along ma or roads. our ob ect ve was to evaluate the association between traffic intensity at home and hospital admissions for respiratory diagnoses among montreal residents older than years. morning peak traffic estimates from the emmej montreal traffic model (motrem ) were used as an indicator of exposure to road traffic outside the homes of those hospitalised. the influence of socioeconomic status on the relationship between traffic intensity and hospital admissions for respiratory diagnoses was explored through assessment of confounding by lodging value, expressed as the dollar average over road segments. this indicator of socioeconomic status, as calculated from the montreal property assessment database, is available at a finer geographic scale than socioeconomic information accessible from the canadian census. there was an inverse relationship between traffic intensity estimates and lodging values for those hospitalised (rho - . , p vehicles during che hour morning peak), even after adjustment for lodging value (crude or . , cl % . - . ; adjusted or . , cl % . - . ). in montreal, elderly persons living along major roads are at higher risk of being hospitalised for respiratory illnesses, which appears not simply to reflect the fact that those living along major roads are at relative economic disadvantage. the paper argues that human beings ought to be at the centre of the concern for sustainable development. while acknowledging the importance of protecting natural resources and the ecosystem in order to secure long term global sustainability, the paper maintain that the proper starting point in the quest for urban sustainability in africa is the 'brown agenda' to improve che living and working environment of che people, especially che urban poor who face a more immediate environmental threat to their health and well-being. as the un-habitat has rightly observed, it is absolutely essential "to ensure that all people have a sufficient stake in the present to motivate them to take part in the struggle to secure the future for humanity.~ the human development approach calls for rethinking and broadening the narrow technical focus of conventional town planning and urban management in order to incorporate the emerging new ideas and principles of urban health and sustainability. i will examine how cities in sub-saharan africa have developed over the last fifty years; the extent to which government policies and programmes have facilitated or constrained urban growth, and the strategies needed to achieve better functioning, safer and more inclusive cities. in this regard i will explore insights from the united nations conferences of the s, especially local agenda of the rio summit, and the istanbul declaration/habitat agenda, paying particular attention to the principles of enablement, decentralization and partnership canvassed by these movements. also, i will consider the contributions of the various global initiatives especially the cities alliance for cities without slums sponsored by the world bank and other partners; che sustainable cities programme, the global campaigns for good governance and for secure tenure canvassed by unhabit at, the healthy cities programme promoted by who, and so on. the concluding section will reflect on the future of the african city; what form it will take, and how to bring about the changes needed to make the cities healthier, more productive and equitable, and better able to meet people's needs. heather jones-otazo, john clarke, donald cole, and miriam diamond urban areas, as centers of population and resource consumption, have elevated emissions and concentrations of a wide range of chemical contaminants. we have developed a modeling framework in which we first ~stimate the emissions and transport of contaminants in a city and second, use these estimates along with measured contaminant concentrations in food, to estimate the potential health risk posed by these che.micals. the latter is accomplished using risk assessment. we applied our modeling framework to consider two groups of chemical contaminants, polycyclic aromatic hydrocarbons (pah) a.nd the flame re~ardants polybrominated diphenyl ethers (pbde). pah originate from vehicles and stationary combustion sources. ~veral pah are potent carcinogens and some compounds also cause noncancer effects. pbdes are additive flame retardants used in polyurethane foams (e.g., car seats, furniture) fer sessions v and cl~ equipm~nt (e.g., compute~~· televisio~s). two out of three pbdes formulations are being voluntarily phased by mdustry due to rmng levels m human tissues and their world-wide distribution. pbdes have been .related to adv.erse neurological, developmental and reproductive effects in laboratory ijlimals. we apphed our modelmg framework to the city of toronto where we considered the southcattral area of by km that has a population of . million. for pah, local vehicle traffic and area sources contribute at least half of total pah in toronto. local contributions to pbdes range from - %, depending on the assumptions made. air concentrations of both compounds are about times higher downtown than km north of toronto. although measured pah concentrations in food date to the s, we estimate that the greatest exposure and contribution to lifetime cancer risk comes from ingestion of infant formula, which is consistent with toxicological evidence. the next greatest exposure and cancer risk are attributable to eating animal products (e.g. milk, eggs, fish). breathing downtown air contributes an additional percent to one's lifetime cancer risk. eating vegetables from a home garden localed downtown contributes negligibly to exposure and risk. for pbdes, the greatest lifetime exposure comes through breast milk (we did not have data for infant formula), followed by ingestion of dust by the toddler and infant. these results suggest strategies to mitigate exposure and health risk. p - (a) immigration and socioeconomic inequalities in cervical cancer screening in toronto, canada aisha lofters, rahim moineddin, maria creatore, mohammad agha, and richard glazier llltroduction: pap smears are recommended for cervical cancer screening from the onset of sexual activity to age . socioeconomic and ethnoracial gradients in self-reported cervical cancer screening have been documented in north america but there have been few direct measures of pap smear use among immigrants or other socially disadvantaged groups. our purpose was to investigate whether immigration and socioeconomic factors are related to cervical cancer screening in toronto, canada. methods: pap smears were identified using fee codes and laboratory codes in ontario physician service claims (ohip) for three years starting in for women age - and - . all women with any health system contact during the three years were used as the denominator. social and economic factors were derived from the canadian census for census tracts and divided into quintiles of roughly equal population. recent registrants, over % of whom are expected to be recent immigrants to canada, were identified as women who first registered for health coverage in ontario after january , . results: among , women age - and , women age - , . % and . %, rtspcctively, had pap smears within three years. low income, low education, recent immigration, visible minority and non-english language were all associated with lower rates (least advantaged quintile:most advantaged quintile rate ratios were . , . , . , . , . , respectively, p < . for all). similar gradients were found in both age groups. recent registrants comprised . % of women and had mm;h lower pap smear rates than non-recent registrants ( . % versus . % for women age - and . % versus . % for women age - ). conclnsions: pap smear rates in toronto fall well below those dictated by evidence-based practice. at the area level, immigration, visible minority, language and socioeconomic characteristics are associated with pap smear rates. recent registrants, representing a largely immigrant group, have particularly low rates. efforts to improve coverage of cervical cancer screening need to be directed to all ~omen, their providers and the health system but with special emphasis on women who recently arrived m ontario and those with social and economic disadvantage. challeges faced: a) most of the resources are now being ~pent in ~reventing the sprea.d of hiv/ aids and maintaining the lives of those already affected. b) skilled medical ~rs~nal are dymg under· mining the capacity to provide the required health care services. ~) th.e comphcat o~s of hiv/aids has complicated the treatment of other diseases e.g. tbs d) the ep dem c has led. to mcrease number of h n requiring care and support. this has further stretched the resources available for health care. orp a s d db . . i methods used on our research: . a simple community survey con ucte y our orgamzat on vo · unteers in three urban centres members of the community, workers and health care prov~ders were interviewed ... . meeting/discussions were organized in hospitals, commun.ity centre a~d with government officials ... . written questionnaires to health workers, doctors and pohcy makers m th.e health sectors. lessors learning: • the biggest-health bigger-go towards hiv/aids prevention • aids are spreading faster in those families which are poor and without education. •women are the most affected. •all health facilities are usually overcrowded with hiv/aids patients. actions needed:• community education oh how to prevent the spread of hiv/aids • hiv/aids testing need to be encouraged to detect early infections for proper medical cover. • people to eat healthy • people should avoid drugs. implications of our research: community members and civic society-introduction of home based care programs to take care of the sick who cannot get a space in the overcrowded public hospitals. prl-v a te sector private sector has established programs to support and care for the staff already affected. government provision of support to care-givers, in terms of resources and finances. training more health workers. introduction: australian prisons contain in excess of , prisoners. as in most other western countries, reliance on 'deprivation of liberty' is increasing. prisoner numbers are increasing at % per annum; incarceration of women has doubled in the last ten years. the impacts on the community are great - % of children have a parent in custody before their th birthday. for aboriginal communities, the harm is greater -aboriginal and/or torres strait islanders are incarcerated at a rate ten times higher than other australians. % of their children have a parent in custody before their th birthday. australian prisons operate under state and territory jurisdictions, there being no federal prison system. eight independent health systems, supporting the eight custodial systems, have evolved. this variability provides an unique opportunity to assess the capacity of these health providers in addressing the very high service needs of prisoners. results: five models of health service provision are identified -four of which operate in one form or another in australia: • provided by the custodial authority (queensland and western australia)• pro· vided by the health ministry through a secondary agent (south australia, the australian capital territory and tasmania) • provided through tendered contract by a private organization (victoria and northern territory) • provided by an independent health authority (new south wales) • (provided by medics as an integral component of the custodial enterprise) since the model of the independent health authority has developed in new south wales. the health needs of the prisoner population have been quantified, and attempts are being made to quantify specific health risks /benefits of incarceration. specific enquiry has been conducted into prisoner attitudes to their health care, including issues such as client information confidentiality and access to health services. specific reference will be made to: • two inmate health surveys • two inmate access surveys, and • two service demand studies. conclusions: the model of care provision, with legislative, ethical, funding and operational independence would seem provide the best opportunity to define and then respond to the health needs of prisoners. this model is being adopted in the united kingdom. better health outcomes in this high-risk group, could translate into healthier families and their communities. p - (a) lnregrated ethnic-specific health care systems: their development and role in increasing access to and quality of care for marginalized ethnic minorities joshua yang introduction: changing demographics in urban areas globally have resulted in urban health systems that are racially and ethnically homogenous relative to the patient populations they aim to serve. the resultant disparities in access to and quality of health care experienced by ethnic minority groups have been addressed by short-term, instirutional level strategies. noticeably absent, however, have been structural approaches to reducing culturally-rooted disparities in health care. the development of ethnic-specific h~alth car~ systems i~ a structural, long-term approach to reducing barriers to quality health care for eth· me mmonty populations. methods: this work is based on a qualitative study on the health care experiences of san francisco chinatown in the united states, an ethnic community with a model ethnic-specific health care infrastrucrure. using snowball sampling, interviews were conducted with key stakeholders and archival research was conducted to trace and model the developmental process that led to the current ethnic-specific health care system available to the chinese in san francisco. grounded theory was the methodology ijltd to analysis of qualitative data. the result of the study is four-stage developmental model of ethnic-specific health infrastrueture development that emerged from the data. the first stage of development is the creation of the human capital resources needed for an ethnic-specific health infrastructure, with emphasis on a bilingual and bicultural health care workforce. the second stage is the effective organization of health care resources for maximal access by constituents. the third is the strengthening and stability of those institutional forms through increased organizational capacity. integration of the ethnic-specific health care system into the mainstream health care infrastructure is the final stage of development for an ethnic-specific infrastructure. conclusion: integrated ethnic-specific health care systems are an effective, long-term strategy to address the linguistic and cultural barriers that are being faced by the spectrum of ethnic populations in urban areas, acting as culturally appropriate points of access to the mainstream health care system. the model presented is a roadmap to empower ethnic communities to act on the constraints of their health and political environments to improve their health care experiences. at a policy level, ethnic-specific health care organizations are an effective long-term strategy to increase access to care and improve qualiiy of care for marginalized ethnic groups. each stage of the model serves as a target area for policy interventions to address the access and care issues faced by culturally and linguistically diverse populations. users in baltimore md: - noya galai, gregory lucas, peter o'driscoll, david celentano, david vlahov, gregory kirk, and shruti mehta introduction: frequent use of emergency rooms (er) and hospitalizations among injection drug users (idus) has been reported and has often been attributed to lack of access to primary health care. however, there is little longitudinal data which examine health care utilization over individual drug use careers. we examined factors associated with hospitalizations, er and outpatient (op) visits among idus over years of follow-up. methods: idus were recruited through community outreach into the aids link to lntravenous experience (alive) study and followed semi-annually. , who had at least follow-up visits were included in this analysis. outcomes were self-reported episodes of hospitalizations and er/op visits in the prior six months. poisson regression was used accounting for intra-person correlation with generalized estimation equations. hits: at enrollment, % were male, % were african-american, % were hiv positive, median age was years, and median duration of drug use was years. over a total of , visits, mean individual rates of utilization were per person years (py) for hospitalizations and per py for er/op visits. adjusting for age and duration of drug use, factors significantly associated with higher rates of hospitalization included hiv infection (relative incidence [ri(, . ), female gender (ri, . ), homelessness (ri, . ), as well as not being employed, injecting at least daily, snorting heroin, havmg a regular source of health care, having health insurance and being in methadone mainte.nance treatment (mmt). similar associations were observed for er/op visits except for mmt which was not associated with er/op visits. additional factors associated with lower er/op visits were use of alcohol, crack, injecting at least daily and trading sex for drugs. % of the cohort accounted for % of total er/op visits, while % of the cohort never reported an op visit during follow-up. . . . lgbt) populations. we hypothesized that prov dmg .appomtments .for p~t ~nts w thm hours would ensure timely care, increase patient satisfaction, and improve practice eff c ency. further, we anticipated that the greatest change would occur amongst our homeless patients.. . methods: we tested an experimental introduction of advanced access scheduling (usmg a hour rule) in the primary care medical clinic. we tracked variables inclu~ing waiting ti~e fo~ next available appointment; number of patients seen; and no-show rates, for an eight week penod pnor to and post introduction of the new scheduling system. both patient and provider satisfaction were assessed using a brief survey ( questions rated on a -pt scale). results and conclusion: preliminary analyses demonstrated shorter waiting times for appointments across the clinic, decreased no-show rates, and increased clinic capacity. introduction of the advanced access scheduling also increased both patient and provider satisfaction. the new scheduling was initiated in july . quantitative analyses to measure initial and sustained changes, and to look at differential responses across populations within our clinic, are currently underway. introduction: there are three recognized approaches to linking socio-economic factors and health: use of census data, gis-based measures of accessibility/availability, and resident self-reported opinion on neighborhood conditions. this research project is primarily concerned with residents' views about their neighborhoods, identifying problems, and proposing policy changes to address them. the other two techniques will be used in future research to build a more comprehensive image of neighborhood depri· vation and health. methods: a telephone survey of london, ontario residents is currently being conducted to assess: a) community resource availability, quality, access and use, b) participation in neighborhood activities, c) perceived quality of neighborhood, d) neighborhood problems, and e) neighborhood cohesion. the survey instrument is composed of indices and scales previously validated and adapted to reflect london specifically. thirty city planning districts are used to define neighborhoods. the sample size for each neighborhood reflects the size of the planning district. responses will be compared within and across neighborhoods. data will be linked with census information to study variation across socio-eco· nomic and demographic groups. linear and gis-based methods will be used for analysis. preliminary results: the survey follows a qualitative study providing a first look at how experts involved in community resource planning and administration and city residents perceive the availability, accessibility, and quality of community resources linked to neighborhood health and wellbeing, and what are the most immediate needs that should be addressed. key-informant interviews and focus groups were used. the survey was pre-tested to ensure that the language and content reflects real experiences of city residents. the qualitative research confirmed our hypothesis that planning districts are an acceptable surrogate for neighborhood, and that the language and content of the survey is appropriate for imple· mentation in london. scales and indices showed good to excellent reliability and validity during the pre· test (cronbach's alpha from . - . ). preliminary results of the survey will be detailed at the conference. conclusions: this study will help assess where community resources are lacking or need improve· ment, thus contributing to a more effective allocation of public funds. it is also hypothesized that engaged neighborhoods with a well-developed sense of community are more likely to respond to health programs and interventions. it is hoped that this study will allow london residents to better understand the needs and problems of their neighborhoods and provide a research foundation to support local understandmg of community improvement with the goal of promoting healthy neighborhoods. p - (a) hiv positive in new york city and no outpatient care: who and why? hannah wolfe and victoria sharp introduction: there are approximately million hiv positive individuals living in the united sta!es. about. % of these know their hiy status and are enrolled in outpatient care. of the remaining yo, approx~mately half do not know their status; the other group frequently know their status but are not enrolled m any .sys~em of outpatient care. this group primarily accesses care through emergency departments. when md cated, they are admitted to hospitals, receive acute care services and then, upon poster sessions v di 'harge, disappear from the health care system until a new crisis occurs, when they return to the emergency department. as a large urban hiv center, caring for over individuals with hiv we have an active inpatient service ".'ith appr~xi~.ately discharges annually. we decided to survey our inpatients to better charactenze those md v duals who were not enrolled in any system of outpatient care. results: % of inpatients were not enrolled in regular outpatient care: % at roosevelt hospital and % at st.luke\'s hospital. substance abuse and homelessness were highly prevalent in the cohort of patients not enrolled in regular outpatient care. % of patients not in care (vs. % of those in care) were deemed in need of substance use treatment by the inpatient social worker. % of those not in care were homeless (vs. % of those in care.) patients not in care did not differ significantly from those in me in terms of age, race, or gender. patients not in care were asked "why not:" the two most frequent responses were: "i haven't really been sick before" and "i'd rather not think about my health. conclusions: this study suggests that there is an opportunity to engage these patients during their stay on the inpatient units and attempt to enroll them in outpatient care. simple referral to an hiv clinic is insufficient, particularly given the burden of homelessness and substance use in this population. efforts are currently underway to design an intervention to focus efforts on this group of patients. p .q (a) healthcare availability and accessibility in an urban area: the case of ibadan city, nigeria in oder to cater for the healthcare need of the populace, for many years after nigeria's politicl independence, empphasis was laid on the construction of teaching, general, and specialist hospital all of which were located in the urban centres. the realisation of the inadequacies of this approach in adequately meeting the healthcare needs of the people made the country to change and adopt the primary health care (phc) system in . the primary health care system which is in line with the alma ata declaration of of , wsa aimed at making health care available to as many people as possible on the basis of of equity and social justice. thus, close to two decades, nigeria has operated primary health care system as a strategy for providing health care for rural and urban dwellers. this study focusing on urban area, examimes the availabilty and accessibility of health care in one of nigeria's urban centre, ibadan city to be specific. this is done within the contest of the country's national heath policy of which pimary health care is the main thrust. the study also offers necessary suggestion for policy consideration. in spite of the accessibility to services provided by educated and trained midwifes in many parts of fars province (iran) there are still some deliveries conducted by untrained traditional birth attendants in rural parts of the province. as a result, a considerable proportion of deliveries are conducted under a higher risk due to unauthorised and uneducated attendants. this study has conducted to reveal the pro· portion of deliveries with un-authorized attendants and some spatial and social factors affecting the selection of delivery attendants. method: this study using a case control design compared some potentially effective parameters indud· ing: spatial, social and educational factors of mothers with deliveries attended by traditional midwifes (n= ) with those assisted by educated and trained midwifes (n= ). the mothers interviewed in our study were selected from rural areas using a cluster sampling method considering each village as a cluster. results: more than % of deliveries in the rural area were assisted by traditional midwifes. there are significant direct relationship between asking a traditional birth attendant for delivery and mother age, the number of previous deliveries and distance to a health facility provided for delivery. significant inverse relationships were found between mother's education and ability to use a vehicle to get to the facilities. conclusion: despite the accessibility of mothers to educated birth attendants and health facilities (according to the government health standards), some mothers still tend to ask traditional birth attendants for help. this is partly because of unrealistic definition of accessibility. the other considerable point is the preference of the traditional attendants for older and less educated mothers showing the necessity of changing theirs knowledge and attitude to understand the risks of deliveries attended by traditional and un-educated midwifes. p - (a) identification and optimization of service patterns provided by assertive community treatment teams in a major urban setting: preliminary findings &om toronto, canada jonathan weyman, peter gozdyra, margaret gehrs, daniela sota, and richard glazier objective: assertive community treatment (act) teams are financed by the ontario ministry of health and long-term care (mohltc) and are mandated to provide treatment, rehabilitation and support services in the community to people with severe and persistent mental illness. there are such teams located in various regions across the city of toronto conducting home visits - times per week to each of their approximately respective clients. each team consists of multidisciplinary health professionals who assist clients to identify their needs, establish goals and work toward them. due to complex referral patterns, the need for service continuity and the locations of supportive housing, clients of any one team are often found scattered across the city which increases home visit travel times and decreases efficiency of service provision. this project examines the locations of clients in relation to the home bases of all act teams and identifies options for overcoming the geographical challenges which arise in a large urban setting. methods: using geographic information systems (gis) we geocoded all client and act agency addresses and depicted them on location maps. at a later stage using spatial methods of network analysis we plan to calculate average travel rimes for each act team, propose optimization of catchment areas and assess potential travel time savings. resnlts: initial results show a substantial scattering of clients from several act teams and substan· rial overlap of visit travel routes for most teams. conclusions: reallocation of catchment areas and optimization of act teams' travel patterns should lead to substantial savings in travel times, increased service efficiency and better utilization of resourc_~· ~e l' .s l _= ._oo, " .ci = ( . - . )), and/or unemployed (or = . , %ci = ij . - . _ people. in multtvanate analysis, after a full adjustment on gender, age, health status, health insura~ce, income, occupat n and tducation level, we observed significant associations between having no rfd and: ~arrtal and_ pare~t hood status (e.g. or single no kids/in couple+kids = . , %ci = ( . - . ()~ quality of relattonsh ps with neighbours (or bad/good= . , %ci = [ . - . )), and length of residence m the neighbourhood (with a dose/effect statistical relationship). . co clusion: gender, age, employment status, mariral and parenthood stat~s as well as ~e gh bourhood anchorage seem to be major predictors of having a rfd, even when um.versa! health i~sur ance has reduced most of financial barriers. in urban contexts, where residential migrattons and single lift (or family ruptures) are frequent, specific information may be conducted to encourage people to ket rfd. :tu~y tries to assess the health effects and costs and also analyse the availability and accessibility to health care for poor. . methods: data for this study was collected by a survey on households of the local community living near the factories and households where radiation hazard w~s n?~ present. ~~art from mor· bidity status and health expenditure, data was collected ~n access, a~ail~b .hty and eff c ency of healrh care. a discriminant analysis was done to identify the vanables that d scnmmate between the study and control group households in terms of health care pattern. a contingent valuation survey was also undertaken among the study group to find out the factors affecting their willingness to pay for health insurance and was analysed using logit model. results: the health costs and indebtedness in families of the study group was high as compared to control group households and this was mainly due to high health expenditure. the discriminant analysis showed that expenditure incurred by private hospital inpatient and outpatient expenditure were significant variables, which discriminated between the two types of households. the logit analysis showed !hat variables like indebtedness of households, better health care and presence of radiation induced illnesses were significant factors influencing willingness to pay for health insurance. the study showed that study group households were dependent on private sector to get better health care and there were problems with access and availability at the public sector. conclusion: the study found out that the quality of life of the local community is poor due to health effects of radiation and the burden of radiation induced illnesses are so high for them. there is an urgent need for government intervention in this matter. there is also a need for the public sector to be efficient to cater to the needs of the poor. a health insurance or other forms of support to these households will improve the quality for health care services, better and fast access to health care facilities and reduces the financial burden of the local fishing community. the prevalence of substance abuse is an increasing problem among low-income urban women in puerto rico. latina access to treatment may play an important role in remission from substance abuse. little is known, however, about latinas' access to drug treatment. further, the role of social capital in substance abuse treatment utilization is unknown. this study examines the relative roles of social capital and other factors in obtaining substance abuse treatment, in a three-wave longitudinal study of women ages - living in high-risk urban areas of puerto rico, the inner city latina drug using study (icldus). social capital is measured at the individual level and includes variables from social support and networks, familism, physical environment, and religion instruments of the icdus. the study also elucidates the role of treatment received during the study in bringing about changes in social capital. the theoretical framework used in exploring the utilization of substance abuse treatment is the social support approach to social capital. the research addresses three main questions: ( t) does social capital predict parti~ipating in treatment programs? ( ) does participation in drug treatment programs increase social capital?, and ( ) is there a significant difference among treatment modalities in affecting change in ~ial capital? the findings revealed no significant association between levels of social capital and gettmg treatment. also, women who received drug treatment did not increase their levels of social capital. the findings, however, revealed a number of significant predictors of social capital and receiving drug ~buse treatment. predictors of social capital at wave iii include employment status, total monthly mcoi:rie, and baseline social capital. predictors of receiving drug abuse treatment include perception of physical health and total amount of money spent on drugs. other different variables were associated to treatment receipt prior to the icldus study. no significant difference in changes of social capital was found among users of different treatment modalities. this research represents an initial attempt to elucidate the two-way relationship between social capital and substance abuse treatment. more work is necessary to unden~nd. ~e role of political forces that promote social inequalities in creating drug abuse problems and ava lab hty of treatment; the relationship between the benefits provided by current treatment poster sessions v sctrings and treatment-seeking behaviors; the paths of recovery; and the efficacy and effectiveness of the trtaanent. and alejandro jadad health professionals in urban centres must meet the challenge of providing equitable care to a population with diverse needs and abilities to access and use available services. within the canadian health care system, providers are time-pressured and ill-equipped to deal with patients who face barriers of poverty, literacy, language, culture and social isolation. directing patients to needed supportive care services is even more difficult than providing them with appropriate technical care. a large proportion of the population do not have equitable access to services and face major problems navigating complex systems. new approaches are needed to bridge across diverse populations and reach out to underserved patients most in need. the objective of this project was to develop an innovative program to help underserved cancer patients access, understand and use needed health and social services. it implemented and evaluated, a pilot intervention employing trained 'personal health coaches' to assist underserved patients from a variety of ethno-linguistic, socio economic and educational backgrounds to meet their supportive cancer care needs. the intervention was tested with a group of underserved cancer patients at the princess margaret hospital, toronto. personal coaches helped patients identify needs, access information, and use supportive care services. triangulation was used to compare and contrast multiple sources of quantitative and qualitative evaluation data provided by patients, personal health coaches, and health care providers to assess needs, barriers and the effectiveness of the coach program. many patients faced multiple barriers and had complex unmet needs. barriers of poverty and language were the easiest to detect. a formal, systematic method to identify and meet supportive care needs was not in place at the hospital. however, when patients were referred to the program, an overwhelming majority of participants were highly satisfied with the intervention. the service also appeared to have important implications for improved technical health care by ensuring attendance at appointments, arranging transportation and translation services, encouraging adherence to therapy and mitigating financial hardship -using existing community services. this intervention identified a new approach that was effective in helping very needy patients navigate health and social services systems. such programs hold potential to improve both emotional and physical health out· comes. since assistance from a coach at the right time can prevent crises, it can create efficiencies in the health system. the successful use of individuals who were not licensed health professionals for this purpose has implications for health manpower planning. needle exchange programs (neps) have been distributing harm reduction materials in toronto since . counterfit harm reduction program is a small project operated out of a community health centre in south-east toronto. the project is operated by a single full-time coordinator, one pan-rime mobile outreach worker and two peers who work a few hours each week. all of counterfit's staff, peers, and volunteers identify themselves as active illicit drug users. yet the program dis~rib utes more needles and safer crack using kits and serves more illicit drug u~rs t~an the comb ~e~ number of all neps in toronto. this presentation will discuss the reasons behind this success, .s~ f cally the extended hours of operation, delivery models, and the inclusion of an. extremely marg ~ahzed community in all aspects of program design, implementation and eva.luat ?n. ~ounterfit was recently evaluated by drs. peggy milson and carol strike, two leading ep dem olog st and researchers in the hiv and nep fields in toronto and below are some of their findings: "the program has experienced considerable success in delivering a high quality, accessible and well-used program .... the pro· gram has allowed (service users) to become active participants in providing. services to others and has resulted in true community development in the best sense. " ... counterf t has ~~n verr succe~sful attracting and retaining clients, developing an effective peer-based model an.d assisting chen~s ~ th a vast range of issues .... the program has become a model for harm red~ctmn progr~ms withm the province of ontario and beyond." in june , the association of ?ntano co~mumty heal~~ <:en· ires recognized counterfit's acheivements with the excellence m community health initiatives award. in kenya, health outcomes and the performance of government health service~ have det~riorated since the late s, trends which coincide with a period of severe resource constramts necessitated by macro-economic stabilization measures after the extreme neo-liberalism of the s. when the govern· ment withdrew from direct service provision as reform trends and donor advocacy suggested, how does it perform its new indirect role of managing relations with new direct health services providers in terms of regulating, enabling, and managing relations with these health services providers? in this paper therefore, we seek to investigate how healthcare access and availability in the slums of nairobi has been impacted upon by the government's withdrawal from direct health care provision. the methodology involved col· leering primary data by conducting field visits to health institutions located in the slum areas of kibera and korogocho in nairobi. purposive random sampling was utilized in this study because this sampling technique allowed the researcher(s) to select those health care seekers and providers who had the required information with respect to the objectives of the study. in-depth interviews using a semi-structured ques· tionnaire were administered ro key informants in health care institutions. this sought to explore ways in which the government and the private sector had responded and addressed in practical terms to new demands of health care provision following the structural adjustment programmes of the s. this was complemented by secondary literature review of publications and records of key governmental, bilateral and multilateral development partners in nairobi. the study notes a number of weaknesses especially of kenya's ministry of health to perform its expected roles such as managing user fee revenue and financial sustainability of health insurance systems. this changing face of health services provision in kenya there· fore creates a complex situation, which demands greater understanding of the roles of competition and choice, regulatory structures and models of financing in shaving the evolution of health services. we rec· ommend that the introduction of user fees, decentralization of service provision and contracting-out of non-clinical to private and voluntary agencies require a new management culture, and new and clear insri· tutional relationships. experience with private sector involvement in health projects underlines the need not only for innovative financial structures to deal with a multitude of contractual, political, market and risks, but also building credible structures to ensure that health services projects are environmentally responsive, socially sensitive, economically viable, and politically feasible. purpose: the purpose of this study is to examine the status of mammography screening utilization and its predictors among muslim women living in southern california. methods: we conducted a cross-sectional study that included women aged ::!: years. we col· leered data using a questionnaire in the primary language of the subjects. the questionnaire included questions on demography; practices of breast self-examination (bse) and clinical breast examination (cbe); utilization of mammography; and family history of breast cancer. bivariate and multiple logistic regression analyses were performed to estimate the odds ratios of mammography use as a function of demographic and other predictor variables. . results: among the women, % were married, % were - years old, and % had family h story of breast cancer. thirty-two percent of the participating women never practiced bse and % had not undergone cbe during the past two years. the data indicated that % of the women did not have mammography in the last two years. logistic regression analysis showed that age ( r= . , % confi· dcnc~ interval (cl)=l. - . ), having clinical breast examination ( r= . , % cl= . - . ), and practtce of self-breast examination ( r= . , % cl= . - . ), were strong predictors of mammography use . . conclusions: the data point to the need for intervention targeting muslim women to inform and motivate th.cm a~ut practices for early detection of breast cancer and screening. further studies are needed to investigate the factors associated with low utilization of mammography among muslim women population in california. we conducted a review of the scientific literature and° government documents to describe ditnational health care program "barrio adentro" (inside the neighborhood). we also conducted qualiurivt interviews with members of the local health committees in urban settings to descrihe the comm unity participation component of the program. rtsmlts: until recently, the venezuelan public health system was characterized by a lack or limited access w health care ( % of the population) and long waiting lists that amounted to denial of service. moit than half of the mds worked in the five wealthiest metropolitan areas of the country. jn the spring oi , a pilot program hired cuban mds to live in the slums of caracas to provide health care to piople who had previously been marginalized from social programs. the program underwent a massive expansion and in only two years , cuban and , venezuelan health care providers were working acmss the country. they provide a daily average of - medical consultations and home visits, c lly out neighborhood rounds, and deliver health prevention initiatives, including immunization programs. they also provide generic medicines at no cost to patients, which treat % of presenting ill-ij!m, barrio adentro aims to build , clinics (primary care), , diagnostic and rehabilitation ctnrres (secondary care), and upgrade the current hospital infrastructure (tertiary care). local health committees survey the community to identify needs and organize a variety of lobby groups to improve dit material conditions of the community. last year, barrio adentro conducted . times the medical visits conducted by the ministry of health. the philosophy of care follows an integrated approach where btalrh is related to housing, education, employment, sports, environment, and food security. conclusions: barrio adentro is a unique collaboration between low-middle income countries to provide health care to people who have been traditionally excluded from social programs. this program shows that it is possible to develop an effective international collaboration based on participatory democracy. low-income americans are at the greatest risk of being uninsured and often face multiple health concerns. this evaluation of the neighborhood health initiative (nh!), an organization which uses multiple programmatic approaches to meet the multiple health needs of clients, reflected the program's many activities and the clients' many service needs. nh! serves low-income, underserved, and hard-to-reach residents in the des moines enterprise community. multiple approaches (fourth-generation evaluation, grounded theory, strengths-and needs-based) and methods (staff and client interviews, concept mapping, observations, qualitative and quantitative analysis) were used to achieve that reflection. results indicate good targeting of residents in the zip code and positive findings in the way of health insurance coverage and reported unmet health needs of clients. program activities were found to match client nttds, validating the organization\'s assessment of clients. important components of nhi were the staff composition and that the organization had become part of both the formal and informal networks. nhi positioned as a link between the target population and local health and social sc:rvice agencies, working to connect residents with services and information as well as aid local agencies in reaching this underserved population. p - (c) welfare: definition by new york city maribeth gregory for an individual who resides in new york city, to obtain health insurance under the medicaid policy one must fall under certain criteria .. (new york city's welfare programs ) if the individual _is on ssi or earns equal to or less than $ per month, he is entitled to receive no more than $ , m resources. a family the size of two would need to earn less than $ per month to qualify for no greater than ss, worth of medicaid benefits. a family of three would qualify for $ , is they earned less than $ per month and so on. introduction: the vancouver gay communiry has a significant number of asian descendan!l. because of their double minority status of being gay and asian, many asian men who have sex with men (msm) are struggling with unique issues. dealing with racism in both mainstream society and the gay communiry, cultural differences, traditional family relations, and language challenges can be some of their everyday srruggles. however, culturally, sexually, and linguistically specific services for asian msm are very limited. a lack of availability and accessibiliry of culturally appropriate sexual health services isolates asian msm from mainstream society, the gay community, and their own cultural communities, deprives them of self-esteem, and endangers their sexual well-being. this research focuses on the qualita· tive narrative voices of asian msm who express their issues related to their sexualiry and the challenges of asking for help. by listening to their voices, practitioners can get ideas of what we are missing and how we need to intervene in order to reach asian msm and ensure their sexual health. methods: since many asian msm are very discreet, it is crucial to build up trust relationships between the researcher and asian msm in order to collect qualitative data. for this reason, a community based participatory research model was adopted by forming a six week discussion group for asian msm. in each group session, the researcher tape recorded the discussion, observed interactions among the participants, and analyzed the data by focusing on participants' personal thoughts, experiences, and emotions for given discussion topics. ra lts: many asian msm share challenges such as coping with a language barrier, cultural differ· ences for interpreting issues and problems, and westerncentrism when they approach existing sexual health services. moreover, because of their fear of being disclosed in their small ethnic communities, a lot of asian msm feel insecure about seeking sexual health services when their issues are related to their sexual orientation. conclflsion: sexual health services should contain multilingual and multicultural capacities to meet minority clients' needs. for asian msm, outreach may be a more effective way to provide them with accessible sexual health services since many asian msm are closeted and are therefore reluctant to approach the services. building a communiry for asian msm is also a significant step toward including them in healthcare services. a communiry-based panicipatory approach can help to build a community for asian msm since it creates a rrust relationship between a worker and clients. p - (c) identifying key techniques to sustain interpretation services for assisting newcomers isolated by linguistic and cultural barriers from accessing health services s. gopi krishna lntrodaetion: the greater toronto area (gta) is home to many newcomer immigrants and other vulnerable groups who can't access health resources due to linguistic, cultural and systemic barriers. linguistic and cultural issues are of special concern to suburbs like scarborough, which is home to thousands of newcomer immigrants and refugees lacking fluency in english. multilingual community ~nterpreter. service~ (mcis) is a non-profit social service organization mandated to provide high quality mterpretanon services. to help newcomers access health services, mcis partnered with the scarborough network of immigrant serving organizations (sniso) to recruit and train volunteer interpreters to accompany clienrs lacking fluency in english and interpret for them to access health services at various locati?ns, incl~~ing communiry ~c:-lth centres/social service agencies and hospitals. the model envisioned agencies recruin~ and mcis ~.mm.g and creating an online database of pooled interpreter resources. this da.tabase, acces& bl~ to all pama~~g ?rganization is to be maintained through administrative/member · ship fees to. be ~ d by each parnapanng organization. this paper analyzes the results of the project, defines and identifies suc:cases before providing a detailed analysis for the reasons for the success . . methods:. this ~per~ q~ntitative (i.e. client numben) and qualitative analysis (i.e. results of key •~ormant m~rv ews with semce ~sers and interpreters) to analyze the project development, training and mplementanon phases of the project. it then identifies the successes and failures through the afore· mentioned analysis. poster sessions vss resljts: the results of the analysis can be summarized as: • the program saw modest success both ia l?lllls of numbers of clients served as well as sustainability at various locations, except in the hospital iririog. o the success of the program rests strongly on the commitment of not just the volunteer interprmr, but on service users acknowledgments through providing transponation allowance, small honororia, letter of reference etc. • the hospital sustained the program better at the hospital due to the iolume and nature of the need, as well as innate capacity for managing and acknowledging volunceers. collc/llsion: it is possible to facilitate and sustain vulnerable newcomer immigrants access to health !ul'ices through the training and commitment of an interpreter volunteer core. acknowledging volunteer commitment is key to the sustenance of the project. this finding is important to immigration and health policy given the significant numbers of newcomer immigrants arriving in canada's urban communities. nity program was established in to provide support to people dying at home, especially those who were waiting for admission to the resi , and age > (males) or > (females) (n= , ). results: based on self-report, an estimated . , ( %) of nyc adults have~ or more cvd risk factors. this population is % male, % white, % black, and % with s years of education. most report good access to health care, indicated by having health insurance ( %), regular doctor ( %), their blood pressure checked within last months ( %), and their choles· terol checked within the past year ( % ). only % reported getting at least minutes of exercise ~ times per week and only % eating ~ servings of fruits and vegetables the previous day. among current smokers, % attempted to quit in past months, but only % used medication or counseling. implications: these data suggest that most nyc adults known to be at high risk for cvd have access to regular health care, but most do not engage in healthy lifestyle or, if they smoke, attempt effective quit strategies. more clinic-based and population-level interventions are needed to support lifestyle change among those at high risk of cvd. introduction: recently, much interest has been directed at "obesogenic" (obesity-promoting) (swinburn, egger & raza, ) built environments, and at geographic information systems (gis) as a tool for their exploration. a major geographical concept is accessibility, or the ease of moving from an origin to a destination point, which has been recently explored in several health promotion-related stud· ies. there are several methods of calculating accessibility to an urban feature, each with its own strengths, drawbacks and level of precision that can be applied to various health promotion research issues. the purpose of this paper is to describe, compare and contrast four common methods of calculating accessibility to urban amenities in terms of their utility to obesity-related health promotion research. practical and conceptual issues surrounding these methods are introduced and discussed with the intent of providing health promotion researchers with information useful for selecting the most appropria e accessibility method for their research goal~ ~ethod: this paper describes methodological insights from two studies, both of which assessed the neighbourhood-level accessibility of fast-food establishments in edmonton, canada -one which used a relatively simple coverage method and one which used a more complex minimum cos method. res.its: both methods of calculating accessibility revealed similar patterns of high and low access to fast-food outlets. however, a major drawback of both methods is that they assume the characteristics of the a~e~ities and of the populations using them are all the same, and are static. the gravity potential method is introduced as an alternative, since it is ·capable of factoring in measures of quality and choice. a n~mber of conceptual and pr~ctical iss~es, illustrated by the example of situational influences on food choice, make the use of the gravity potential model unwieldy for health promotion research into sociallydetermined conditions such as obesity. co.nclusions: i~ ~ommended that geographical approaches be used in partnership with, or as a foun~ation for, ~admonal exploratory methodologies such as group interviews or other forms of commumty consultation that are more inclusive and representative of the populations of interest. qilhl in los angeles county ,,..ia shaheen, richard casey, fernando cardenas, holman arthurs, and richard baker ~the retinomax autorefractor has been used for vision screening of preschool age childien. ir bas been suggested to be used and test school age children but not been validated in this age poup. ob;taiw: to compare the results of retinomax autorefractor with findings from a comprehensive i!' examination using wet retinoscopy for refractive error. mllhods: children - years old recruited from elementary schools at los angeles county were iaml with snellen's chart and the retinomax autorefractor and bad comprehensive eye examination with dilation. the proportion of children with abnormal eye examination as well as diesensitiviry and specificity of the screening tools using retinomax autorefractor alone and in combinalion wirh snellen's chart. results of the children enrolled in the study (average age= . ± . years; age range, - years), ?% had abnormal eye examination using retinoscopy with dilation. for the lerinomax, the sensitivity was % ( % confidence interval [ci] %- %), and the specificity was % ( % ci, %- o/o). simultaneous testing using snellen's chart and retinomax resulted in gain in sitiviry ( %, % cl= , ), and loss in specificity ( %, % cl= %- %). the study showed that screening school age children with retinomax autorefractor could identify most cases with abnormal vision but would be associated with many false-positive results. simuhaneous resting using snellen's chart and retinomax maximize the case finding but with very low specificiry. mdhotjs: a language-stratified, random sample of members of the college of family physicians of canada received a confidential survey. the questionnaire collected data on socio-demographic characteristics, medical training, practice type, setting and hcv-related care practices. the self-adminisratd questionnaire was also made available to participants for completion on the internet. batdti: response proportion was %. median age was years ( % female) and the proporlionoffrench questionnaires was %. approximately % had completed family medicine residency lllining in canada; median year of training completion was . sixty-seven percent, % and % work in private offices/clinics, community hospitals and emergency departments, respectively. regarding ~practices, % had ever requested a hcv test and % of physicians had screened for hcv iafrction in rhe past months· median number of tests was . while % reported having no hcv-uaed patients in their practic~, % had - hcv-infected patients. regarding the level of hcv care provided, . % provide ongoing advanced hcv care including treatment and dose monitoring for ctmduions: in this sample of canadian family physicians, most had pro~ided hcv screening. to •least one patient in the past year. less than half had - hcv-infected patients and % provide ~:relared care the role of socio-demographic factors, medical training as wel_i as hcv ca~e percep-lldas rhe provision of appropriate hcv screening will be examined and described at the time of the canference. ' - (c) healthcare services: the context of nepal meen poudyal chhetri """ tl.ction healthcare service is related with the human rights and fundamental righ~ of the ci~ ciaaiuntry. however, the growing demand foi health care services, quality heal~care service, accessib b~ id die mass population and paucity of funds are the different but interrelated issues to .be ~ddressed. m nepat. n view of this context, public health sector in nepal is among other sectors, which is struggling -.i for scarce resources. . . . nepal, the problems in the field of healthcare servic~s do not bnut ~o the. paucity of faads and resources only, but there are other problems like: rural -urban imbalance, regional unbalance, poster sessio~ f the ll ·m ·ted resources poor healthcare services, inequity and inaccessibility of the poor management o , . poor people of the rural, remote and hilly areas for the healthcare services and so on.. . . . · . i f ct the best resource allocation is the one that max m zes t e sum o m ivi ua s u · ea t services. n a , · h d' ·b · · · h . ·t effi.ciency and efficient management are correlated. it might be t e re istn utmn of mes. ence, equi y, . . . . . income or redistribution of services. moreover, maximizanon of available resources, qua tty healthcare services and efficient management of them are the very important and necessary tools and techmques to meet the growing demand and quality healthcare services in nepal. p - (a) an jn-depth analysis of medical detox clients to assist in evidence based decision making xin li, huiying sun, ajay puri, david marsh, and aslam anis introduction: problematic substance use represents an ever-increasing public health challenge. in the vancouver coastal health (vch) region, there are more than , individuals having some probability of drug or alcohol dependence. to accommodate this potential demand for addiction related services, vch provides various services and treatment, including four levels of withdrawal management services (wms). clients seeking wms are screened and referred to appropriate services through a central telephone intake service (access i). the present study seeks to rigorously evaluate one of the services, vancouver detox, a medically monitored -bed residential detox facility, and its clients. doing so will allow decision makers to utilize evidence based decision-making in order to improve the accessibility and efficiency of wms, and therefore, the health of these clients. methods: we extract one-year data (october , -september , from an efficient and comprehensive database. the occupancy rate of the detox centre along with the clients' wait time for service and length of stay (los) are calculated. in addition, the effect of seasonality on these variables and the impact of the once per month welfare check issuance on the occupancy rate are also evaluated. results: among the clients (median age , % male) who were referred by access! to vancouver detox over the one-year period, were admitted. the majority ( %) of those who are not admitted are either lost to follow up (i.e., clients not having a fixed address or telephone) or declined service at time of callback. the median wait time was day [q -ql: - ], the median los was days iq -qt: - ], and the average bed occupancy rate was %. however, during the threeday welfare check issue period the occupancy rate was lower compared to the other days of the year % vs. %, p conclusion: our analysis indicates that there was a relatively short wait time at vancouver detox, however % of the potential clients were not served. in addition, the occupancy rate declined during the welfare check issuance period and during the summer. this suggests that accessibility and efficiency at vancouver detox could be improved by specifically addressing these factors. background: intimate partner violence (ipv) is associated with acute and chronic physical and men· tal health outcomes for women resulting in greater use of health services. yet, a vast literature attests to cultural variations in perceptions of health and help-seeking behaviour. fewer studies have examined differences in perceptions of ipv among women from ethnocultural communities. the recognition, definition, and understanding of ipv, as well as the language used to describe these experiences, may be different in these communities. as such, a woman's response, including whether or not to disclose or seek help, may vary according to her understanding of the problem. methods: this pilot study explores the influence of cultural factors on perceptions of and responses to ipv among canadian born and immigrant young women. in-depth focus group interviews were con· ducted with women, aged to years, living in toronto. open-ended and semi-structured interview questions were designed to elicit information regarding how young women socially construct jpv and where they would go to receive help. interviews were transcribed, then read and independently coded by the research team. codes were compared and disagreements resolved. qualitative software qsr n was used to assist with data management. . ruu~ts_: res~nses_abo~t what constitutes ipv were similar across the study groups. when considering specific ab.us ve ~ tuanons and types of relationships, participants held fairly relativistic views about ipv, especially with regard to help-seeking behaviour. cultural differences in beliefs about normaive m;ile/femal~ relations. familial.roles, and customs governing acceptable behaviours influenced partictpants perceptions about what n ght be helpful to abused women. interview data highlight the social l ter srnfons v suucrural _impact these factors ha:e on you?g women and provide details regarding the dynamics of cibnocultur~ m~uences on help-~eekmg behav ur: t~e ro~e of such factors such as gender inequality within rtlaoo?sh ps and t_he ~erce ved degree of ~oc al solat on and support nerworks are highlighted. collc~ the~ findmgs unde~score the _ mporta_nc_e of understanding cultural variations in percrprions of ipv ~ relanon to ~elp-seekmg beha~ ':'ur. th s_mformation is critical for health professionals iodiey may connnue developmg culturally sensmve practices, including screening guidelines and protorol s. ln addition, _this study demonstr~tes that focus group interviews are valuable for engaging young romen in discussions about ipv, helpmg them to 'name' their experiences, and consider sources of help when warranted. p -s (a) health problems and health care use of young drug users in amsterdam .wieke krol, evelien van geffen, angela buchholz, esther welp, erik van ameijden, and maria prins / trod ction: recent advances in health care and drug treatment have improved the health of populations with special social and health care needs, such as drug users. however, still a substantial number dots not have access to the type of services required to improve their health status. in the netherlands, tspccially young adult drug users (yad) whose primary drug is cocaine might have limited access to drugrreatment services. in this study we examined the history and current use of (drug associated) treatmmt services, the determinants for loss of contact, and the current health care needs in the young drug mm amsterdam study (yodam). methods: yodam started in and is embedded in the amsterdam cohort study among drug mm. data were derived from y ad aged < years who had used cocaine, heroin, ampheramines and i or methadone at least days a week during the months prior to enrolment. res lts:of yao, median age was years (range: - years), % was male and % had dutch nationality at enrolment. nearly all participants ( %) reported a history of contact with drug llt.lnnent services (methadone maintenance, rehabilitation clinics and judicial treatment), mental health car? (ambulant mental care and psychiatric hospital) or general treatment services (day-care, night-care, hdp for living arrangements, work and finance). however, only % reported contact in the past six l!xlllths. this figure was similar in the first and second follow-up visit. among y ad who reported no current contact with the health care system, % would like to have contact with general treatment serl' icts. among participants who have never had contact with drug treatment services, % used primarily cocaine compared with % and % among those who reported past or current contact, respectively. saied on the addiction severity index, % reported at least one mental health problem in the past days, but only % had current contact with mental health services. concl sion: results from this study among young adult drug users show that despite a high contact rm with health care providers, the health care system seems to lose contact with yao. since % indicatt the need of general treatment services, especially for arranging house and living conditions, health m services that effectively integrate general health care with drug treatment services and mental health care might be more successful to keep contact with young cocaine users. mtthods: respondents included adults aged and over who met dsm-iv diagn?snc criteria for an anxiety or depressive disorder in the past months. we performed two sets of logisnc regressmns. thtdichotomous dependent variables for each of the regressions indicated whether rhe respondenr_vis-ud a psychiatrist, psychologist, family physician or social worker in the _past_ months. no relationship for income. there was no significant interaction between educatmn an mco~:· r: ::or respondents with at least a high school education to seek help ~rom any of the four servic p were almost twice that for respondents who had not completed high school. th . d ec of analyses found che associacion becween educacion and use of md-provided care e secon s · · be d · · ·f· ly ·n che low income group for non-md care, the assoc anon cween e ucatlon and was s gm icant on -· . . . . use of social workers was significant in both income groups, but significant only for use of psychologists in che high-income group. . . . conclusion: we found differences in healch service use by education level. ind v duals who have nor compleced high school appeared co use less mental he~lt~ servi~es provided ~y psyc~iatrists, psycholo· gists, family physicians and social workers. we found limited e.v dence _suggesting the influence of educa· tion on service use varies according to income and type of service provider. results suggesc there may be a need to develop and evaluate progr~ms.designe~ to deliver targeted services to consumers who have noc completed high school. further quahtanve studies about the expen· ence of individuals with low education are needed to clarify whether education's relationship with ser· vice use is provider or consumer driven, and to disentangle the interrelated influences of income and education. system for homeless, hiv-infected patients in nyc? nancy sahler, chinazo cunningham, and kathryn anastos introduction: racial/ethnic disparities in access to health care have been consistently documented. one potential reason for disparities is that the cultural distance between minority patients and their providers discourage chese patients from seeking and continuing care. many institucions have incorporated cultural compecency craining and culturally sensicive models of health care delivery, hoping co encourage better relacionships becween patients and providers, more posicive views about the health care system, and, ulcimacely, improved health outcomes for minority patients. the current scudy tests whether cultural distance between physicians and patients, measured by racial discordance, predicts poorer patient attitudes about their providers and the health care system in a severely disadvantaged hiv-infected population in new york city that typically reports inconsistent patterns of health care. methods: we collected data from unscably housed black and latino/a people with hiv who reported having a regular health care provider. we asked them to report on their attitudes about their provider and the health care system using validated instruments. subjects were categorized as being racially "concordant" or "discordant" with their providers, and attitudes of these two groups were compared. results: the sample consisted of ( %) black and ( %) latino/a people, who reported having ( %) black physicians, ( %) latino/a physicians, ( %) white physicians, and ( %) physicians of another/unknown race/ethnicity. overall, ( %) subjects had physicians of a different race/ethnicity than their own. racial discordance did not predict negative attitudes about rela· tionship with providers: the mean rating of a i-item trust in provider scale (lo=high and o=low) was . for both concordant and discordant groups, and the mean score in -icem relationship with provider scale ( =high and !=low) was . for both groups. however discordance was significantly associated with distrust in che health care syscem: che mean score on a -icem scale ( =high discrust and l=low distrust) was . for discordant group and . for che concordant group (t= . , p= . ). we further explored these patterns separacely in black and lacino/a subgroups, and using different strategies ro conceptualize racial/ethic discordance. conclusions: in this sample of unscably housed black and latino/a people who receive hiv care in new york city, having a physician from the same racial/ethnic background may be less important for developing a positive doctor-patient relationship than for helping the patients to dispel fear and distrust about the health care system as a whole. we discuss the policy implications of these findings. ilene hyman and samuel noh . .abstract objectiw: this study examines patterns of mental healthcare utilization among ethiopian mm grants living in toronto. methods: a probability sample of ethiopian adults ( years and older) completed structured face-to-face interviews. variables ... define, especially who are non-health care providers. plan of analysis. results: approximately % of respondents received memal health services from mainstream healthcare providers and % consulted non-healthcare professionals. of those who sought mental health services from mainstream healthcare providers, . % saw family physicians, . % visited a psychiatrist. and . % consulted other healthcare providers. compared with males, a significantly higher proportion gsfer sessions v ri ftlnales consulted non-healthcare_ professionals for emotional or mental health problems (p< . ). tlbile ethiopian's overall use of mamstream healthcare services for emotional problems ( %) did not prlydiffer from the rate ( %) of the general population of ontario, only a small proportion ( . %) rjerhiopians with mental health needs used services from mainstream healthcare providers. of these, !oj% received family physicians' services, . % visited a psychiatrist, and . % consulted other healthll/c providers. our data also suggested that ethiopian immigrants were more likely to consult tradioooal healers than health professionals for emotional or mental health problems ( . % vs. . % ). our bivariate analyses found the number of somatic symptoms and stressful life events to be associated with an increased use of medical services and the presence of a mental disorder to be associated with a dfcreased use of medical services for emotional problems. however, using multivariate methods, only die number of somatic symptoms remained significantly associated with use of medical services for emooonal problems. diu#ssion: study findings suggest that there is a need for ethnic-specific and culturally-appropriate mrcrvention programs to help ethiopian immigrants and refugees with mental health needs. since there ~a strong association between somatic symptoms and the use family physicians' services, there appears robe a critical role for community-based family physicians to detect potential mental health problems among their ethiopian patients, and to provide appropriate treatment and/or referral. the authors acknowledge the centre of excellence for research in immigration and settlement (ceris) in toronto and canadian heritage who provided funding for the study. we also acknowledge linn clark whose editorial work has improved significantly the quality of this manuscript. we want to thank all the participants of the study, and the ethiopian community leaders without whose honest contributions the present study would have not been possible. this paper addresses the impact of the rationalization of health-care services on the clinical decision-making of emergency physicians in two urban hospital emergency departments in atlantic canada. using the combined strategies of observational analysis and in-depth interviewing, this study provides a qualitative understanding of how physicians and, by extension, patients are impacred by the increasing ancmpts to make health-care both more efficient and cost-effective. such attempts have resulted in significantly compromised access to primary care within the community. as a consequence, patients are, out of necessity, inappropriately relying upon emergency departments for primary care services as well as access to specialty services. within the hospital, rationalization has resulted in bed closures and severely rmricted access to in-patient services. emergency physicians and their patients are in a tenuous position having many needs but few resources. furthermore, in response to demands for greater accountability, physicians have also adopted rationality in the form of evidence-based medicine. ultimately, ho~ever, rationality whether imposed upon, or adopted by, the profession significantly undermines physu.: ans' ability to make decisions in the best interests of their patients. johnjasek, gretchen van wye, and bonnie kerker introduction: hispanics comprise an increasing proportion of th.e new york city (nyc) populanon !currently about %). like males in the general population, h spamc males (hm) have a lower prrval,nce of healthcare utilization than females. however, they face additional access barriers such as bnguage differences and high rates of uninsurance. they also bear a heavy burden of health problems lllehasobesity and hiv/aids. this paper examines patterns of healthcare access and ut hzat on by hm compared to other nyc adults and identifies key areas for intervention. . . . and older are significantly lower than the nhm popu anon . v. . , p<. ), though hi\' screening and immunizations are comparable between the two groups. conclusion: findings suggest that hm have less access t? healthcare than hf or nhm. hown r, hm ble to obtain certain discrete medical services as easily as other groups, perhapsdueto!rtor are a hm. i i . subsidized programs. for other services, utilization among s ower. mprovmg acc~tocareinthis group will help ensure routine, quality care, which can lead to a greater use of prevennve services iii! thus bener health outcomes. introduction: cancer registry is considered as one of the most important issues in cancer epidemiology and prevention. bias or under-reporting of cancer cases can affect the accuracy of the results of epidemiological studies and control programs. the aim of this study was to assess the reliability of the regional cancer report in a relatively small province (yasuj) with almost all facilities needed for c llcll diagnosis and treatment. methods: finding the total number of cancer cases we reviewed records of all patients diagnoicd with cancer (icd - ) and registered in any hospital or pathology centre from until i n yasuj and all ( ) surrounding provinces. results: of patients who were originally residents of yasui province, . % wereaccoulll!d for yasuj province. the proportion varies according to the type of cancer, for exarnplecancetsofdiglstive system, skin and breast were more frequently reported by yasuj's health facilities whereas cancmoi blood, brain and bone were mostly reported by neighbouring provinces. the remaining cases ( . % were diagnosed, treated and recorded by neighbouring provinces as their incident cases. this is partly because of the fact that patients seek medical services from other provinces as they believed that the facil. ities are offered by more experienced and higher quality stuffs and their relative's or temporary acooiii' modation addresses were reported as their place of residence. conclusion: measuring the spatial incidence of cancer according to the location of report ortht current address affected the spatial statistics of cancer. to correct this problem recording the permanm! address of diagnosed cases is important. p - (c). providing primary healthcare to a disadvantaged population at a university-run commumty healthcare facility tracey rickards the. c:ommuni~y .h~alth ~linic (chc) is a university sponsored nurse-managed primary bealthwt (p~c:l clime. the clm c is an innovative model of healthcare delivery in canada that has integrated tht principles of phc ser · · h' . vices wit ma community development framework. it serves to provide access to phc services for members of th · · illi · dru is ii be . . e community, particularly the poor and those who use or gs, we mg a service-learning facil'ty f d · · · · · · d rionll h . . .,m.:. · t · . meet c ient nee s. chmc nursing and social work staff and srudents r·--· ipa em various phc activities and h .l.hont" less i . f . outreac services in the local shelters and on the streels to'"" popu auon o fredericton as well th chc · model iii fosterin an on oi : . • e promotes and supports a harm reduction . · local d!or an~ h ng ~art:ersh p with aids new brunswick and their needle exchange program, w tha ing condoms and :xu:t h:~~~e e~aint~nance therapy clients, and with the clie~ts themselves ~_r; benefits of receiving health f ucation, a place to shower, and a small clothing and food oai~· care rom a nurse p · · d d · --""~'i"· are evidenced in th r research that involved needsaans mvo ves clients, staff, and students. to date the chc has unacn- · sessment/enviro i . d ; •• '"""" ll eva uanon. the clinic has also e . d nmenta scan, cost-benefit analysis, an on-go...,, "".'i'~ facility and compassionate lea x~mme the model of care delivery' focusing on nursing roles wi~ cj rmng among students. finally, the clinic strives to share the resu•p v . -arch with the community in which it provides service by distributing a bi-monthly newsletter, and plllicipating in in-services and educational sessions in a variety of situations. the plan for the future is coolinued research and the use of evidence-based practice in order to guide the staff in choosing how much n~ primary healthcare services to marginalized populations will be provided. n- (c) tuming up the volume: marginalized women's health concerns tckla hendrickson and betty jane richmond bdrotbu:tion: the marginalization of urban women due to socio-economic status and other determinants negatively affects their health and that of their families. this undermines the overall vitaliry of urban communities. for example, regarding access to primary health care, women of lower economic surus and education levels are less likely to be screened for breast and cervical cancer. what is not as widely reported is how marginalized urban women in ontario understand and articulate their lack of access to health care, how they attribute this, and the solutions that they offer. this paper reports on the rnults of the ontario women's health network (owhn) focus group project highlighting urban women's concerns and suggestions regarding access to health care. it also raises larger issues about urban health, dual-purpose focus group design, community-based research and health planning processes. mdhods: focus group methodology was used to facilitate a total of discussions with urban and rural women across ontario from to . the women were invited to participate by local women's and health agencies and represented a range of ages, incomes, and access issues. discussions focussed on women's current health concerns, access to health care, and information needs. results were analyzed using grounded theory. the focus groups departed from traditional focus group research goals and had two purposes: ) data collection and dissemination (representation of women's voices), and ) fostering closer social ties between women, local agencies, and owhn. the paper provides a discussion and rationale for a dual approach. rax/ts: the results confirm current research on women's health access in women's own voices: urban women report difficulty finding responsive doctors, accessing helpful information such as visual aids in doctors' offices, and prohibitive prescription costs, in contrast with rural women's key concern of finding a family doctor. the research suggests that women's health focus groups can address access issues by helping women to network and initiate collective solutions. the study shows that marginalized urban women are articulate about their health conctrns and those of their families, often understanding them in larger socio-economic frameworks; howtver, women need greater access to primary care and women-friendly information in more languages and in places that they go for other purposes. it is crucial that urban health planning processes consult directly with women as key health care managers, and turn up the volume on marginalized women's voices. women: an evaluation of awareness, attitudes and beliefs introduction: nigeria has one of the highest rates of human immunodeficiency virus ihivi seroprrvalence in the world. as in most developing countries vertical transmission from mother to child account for most hiv infection in nigerian children. the purpose of this study was ro. determine the awareness, attitudes and beliefs of pregnant nigerian women towards voluntary counseling and testing ivct! for hiv. mnbod: a pre-tested questionnaire was used to survey a cross section '.>f. pregnant women ~t (lrlleral antenatal clinics in awka, nigeria. data was reviewed based on willingness to ~c~ept or re ect vct and the reasons for disapproval. knowledge of hiv infection, routes of hiv transm ssmn and ant rnroviral therapy iart) was evaluated. hsults: % of the women had good knowledge of hiv, i % had fair knowledge while . % had poor knowledge of hiv infection. % of the women were not aware of the association of hreast milk feeding and transmission of hiv to their babies. majority of the women % approved v~t while % disapproved vct, % of those who approved said it was because vct could ~educe risk of rransmission of hiv to their babies. all respondents, % who accepted vc.i ~ere willing to be tnted if results are kept confidential only % accepted to be tested if vc.t results w. be s~ared w .th pinner and relatives % attributed their refusal to the effect it may have on their marriage whale '-gave the social 'and cultural stigmatization associated with hiv infection for their r~fusal.s % wall accept vct if they will be tested at the same time with their partners. ~ of ~omen wall pref~r to breast feed even if they tested positive to hiv. women with a higher education diploma were times v more likely to accept vct. knowledge of art for hiv infected pregnant women as a means of pre. vention of maternal to child transmission [pmtct) was generally poor, % of respondents wm aware of art in pregnancy. conclusion: the acceptance of vct by pregnant women seems to depend on their understanding that vct has proven benefits for their unborn child. socio-cultur al factors such as stigmatizationof hiv positive individuals appears to be the maj_or impedi~ent towards widespread acceptanee of ycr in nigeria. involvemen t of male partners may mpro~e attitudes t~wa~ds vct:the developmentofm novative health education strategies is essential to provide women with mformanon as regards the benefits of vct and other means of pmtct. p - (c) ethnic health care advisors in information centers on health care and welfare in four districts of amsterdam arlette hesselink, karien stronks, and arnoud verhoeff introduction : in amsterdam, migrants report a "worse actual health and a lower use of health care services than the native dutch population. this difference might be partly caused by problems migrants have with the dutch language and health care and welfare system. to support migrants finding their way through this system, in four districts in amsterdam information centers on health care and welfare were developed in which ethnic health care advisors were employed. their main task is to provide infor· mation to individuals or groups in order to bridge the gap between migrants and health care providers. methods: the implementat ion of the centers is evaluated using a process evaluation in order to give inside in the factors hampering and promoting the implementat ion. information is gathered using reports, attending meetings of local steering groups, and by semi-structu red interviews with persons (in)directly involved in the implementat ion of the centers. in addition, all individual and groupcontaets of the health care advisors are registered extensively. results: since four information centers, employing ethnic health care advisors, are implemented. the ethnicity of the health care advisors corresponds to the main migrant groups in the different districts (e.g. moroccan, turkeys, surinamese and african). depending on the local steering groups, the focus of the activities of the health care advisors in the centers varies. in total, around individual and group educational sessions have been registered since the start. most participants were positive about the individual and group sessions. the number of clients and type of questions asked depend highly on the location of the centers (e.g. as part of a welfare centre or as part of a housing corporation). in all districts implementa tion was hampered by lack of ongoing commitment of parties involved (e.g. health care providers, migrant organization s) and lack of integration with existing health care and welfare facilities. discussion: the migrant health advisors seem to have an important role in providing information on health and welfare to migrant clients, and therefore contribute in bridging the gap between migrants and professionals in health care and welfare. however, the lack of integration of the centers with the existing health care and welfare facilities in the different districts hampers further implementation . therefore, in most districts the information centres will be closed down as independent facilicities in the near future, and efforts are made to better connect the position of migrant health advisor in existing facilities. the who report ranks the philippines as ninth among countries with a high tb prevalence. about a fourth of the country's population is infected, with majority of cases coming from the lower socioeconomic segments of the community. metro manila is not only the economic and political capital of the philippines but also the site of major universities and educational institutions. initial interviews with the school's clinicians have established the need to come up with treatment guidelines and protocols for students and personnel when tb is diagnosed. these cases are often identified during annual physical examinations as part of the school's requirements. in many instances, students and personnel diagnosed with tb are referred to private physicians where they are often lost to follow-up and may have failure of treatment due to un monitored self-administered therapy. this practice ignores the school clinic's great potential as a tb treatment partner. through its single practice network (spn) initiative, the philippine tuberculosis initiatives for the private sector (philippine tips), has established a model wherein school clinics serve as satellite treatment partners of larger clinics in the delivery of the directly observed treatment, short course (dots) protocol. this "treatment at the source" allows school-based patients to get their free government-suppl ied tb medicines from the clinic each day. it also cancels out the difficulty in accessing medicines through the old model where the patient has to go to the larger clinic outside his/her school to get treatment. the model also enables the clinic to monitor the treatment progress of the student and assumes more responsibility over their health. this experience illustrates how social justice in health could be achieved from means other than fund generation. the harnessing of existing health service providers in urban communities through standardized models of treatment delivery increases the probability of treatment success, not only for tb but for other conditions as well. p - (c) voices for vulnerable populations: communalities across cbpr using qualitative methods martha ann carey, aja lesh, jo-ellen asbury, and mickey smith introduction: providing an opportunity to include, in all stages of health studies, the perspectives and experiences of vulnerable and marginalized populations is increasingly being recognized as a necessary component in uncovering new solutions to issues in health care. qualitative methods, especially focus groups, have been used to understand the perspectives and needs of community members and clinical staff in the development of program theory, process evaluation and refinement of interventions, and for understanding and interpreting results. however, little guidance is available for the optimal use of such information. methods: this presentation will draw on diverse experiences with children and their families in an asthma program in california, a preschool latino population in southern california, a small city afterschool prevention program for children in ohio, hiv/aids military personnel across all branches of the service in the united states, and methadone clinic clients in the south bronx in new york city. focus groups were used to elicit information from community members who would not usually have input into problem definitions and solutions. using a fairly common approach, thematic analysis as adapted from grounded theory, was used to identify concerns in each study. next we looked across these studies, in a meta-synthesis approach, to examine communalities in what was learned and in how information was used in program development and refinement. results: while the purposes and populations were diverse, and the type of concerns and the reporting of results varied, the conceptual framework that guided the planning and implementation of each study was similar, which led to a similar data analysis approach. we will briefly present the results of each study, and in more depth we will describe the communalities and how they were generated. conclusions: while some useful guidance for planning future studies of community based research was gained by looking across these diverse studies, it would be useful to pursue a broader examination of the range of populations and purposes to more fully develop guidance. background: the majority of studies examining the relationship between residential environments and cardiovascular disease have used census derived measures of neighborhood ses. there is a need to identify specific features of neighborhoods relevant to cardiovascular disease risk. we aim to ) develop methods· data on neighborhood conditions were collected from a telephone survey of s, fesi· dents in balth:.ore, md; forsyth county, nc; and new york, ny. a sample of of the i.ni~~l l'elpondents was re-interviewed - weeks after the initial interview t~ measure the tes~-~etest rebab ~ ty of ~e neighborhood scales. information was collected across seven ~e ghborho~ cond ~ons (aesth~~ ~uah~, walking environment, availability of healthy foods, safety, violence, social cohesion, and acnvmes with neighbors). neighborhoods were defined as census tracts or homogen~us census tra~ clusters. ~sycho metric properties.of the neighborhood scales were accessed by ca~cu~~.ng chronba~h s alpha~ (mtemal consistency) and intraclass correlation coefficients (test-r~test reliabilmes) .. pear~n s .corre~anons were calculated to test for associations between indicators of neighborhood ses (tncludmg d mens ons of race/ ethnic composition, family structure, housing, area crowding, residential stability, education, employment, occupation, and income/wealth) and our seven neighborhood scales. . chronbach's alphas ranged from . (walking environment) to . (violence). intraclass correlations ranged from . (waling environment) to . (safety) and wer~ high~~~ . ~ for ~urout of the seven neighborhood dimensions. our neighborhood scales (excluding achv hes with neighbors) were consistently correlated with commonly used census derived indicators of neighborhood ses. the results suggest that neighborhood attributes can be reliably measured. further development of such scales will improve our understanding of neighborhood conditions and their importance to health. childhood to young adulthood in a national u.s. sample jen jen chang lntrodfldion: prior studies indicate higher risk of substance use in children of depressed mothers, but no prior studies have followed up the offspring from childhood into adulthood to obtain more precise estimates of risk. this study aimed to examine the association between early exposure to maternal depl'elsive symptoms (mds) and offspring substance use across time in childhood, adolescence, and young adulthood. methods: data were obtained from the national longitudinal survey of youth. the study sample includes , mother-child/young adult dyads interviewed biennially between and with children aged to years old at baseline. data were gathered using a computer-assisted personal interview method. mds were measured in using the center for epidemiologic studies depression scale. offspring substance use was assessed biennially between and . logistic and passion regression models with generalized estimation equation approach was used for parameter estimates to account for possible correlations among repeated measures in a longitudinal study. rnlllta: most mothers in the study sample were whites ( %), urban residents ( %), had a mean age of years with at least a high school degree ( %). the mean child age at baseline was years old. offspring cigarette and alcohol use increased monotonically across childhood, adolescence, and young adulthood. differential risk of substance use by gender was observed. early exposure to mds was associated with increased risk of cigarette (adjusted odds ratio (aor) = . , % confidence interval ( ): . , . ) and marijuana use (aor = . , % ci: . , . ), but not with alcohol use across childhood, adolescence, and young adulthood, controlling for a child's characteristics, socioeconomic status, ~ligiosity, maternal drug use, and father's involvement. among the covariates, higher levels of father's mvolvement condluion: results from this study confirm previous suggestions that maternal depressive symptoms are associated with adverse child development. findings from the present study on early life experi-e~ce have the potential to inform valuable prevention programs for problem substance use before disturbances become severe and therefore, typically, much more difficult to ameliorate effectively. the ~act (~r-city men~ health study predicting filv/aids, club and other drug transi-b~) study a multi-level study aimed at determining the association between features of the urban enyjronment mental health, drug use, and risky sexual behaviors. the study is randomly sampling foster sessions v neighborhood residents and assessing the relations between characteristics of ethnographically defined urban neighborhoods and the health outcomes of interest. a limitation of existing systematic methods for evaluating the physical and social environments of urban neighborhoods is that they are expensive and time-consuming, therefore limiting the number of times such assessments can be conducted. this is particularly problematic for multi-year studies, where neighborhoods may change as a result of seasonality, gentrification, municipal projects, immigration and the like. therefore, we developed a simpler neighborhood assessment scale that systematically assessed the physical and social environment of urban neighborhoods. the impact neighborhood evaluation scale was developed based on existing and validated instruments, including the new york city housing and vacancy survey which is performed by the u.s. census bureau, and the nyc mayor's office of operations scorecard cleanliness program, and modified through pilot testing and cognitive testing with neighborhood residents. aspects of the physical environment assessed in the scale included physical decay, vacancy and construction, municipal investment and green space. aspects of the social environment measured include social disorder, social trust, affluence and formal and informal street economy. the scale assesses features of the neighborhood environment that are determined by personal (e.g., presence of dog feces), community (e.g., presence of a community garden), and municipal (e.g., street cleanliness) factors. the scale is administered systematically block-by-block in a neighborhood. trained research staff start at the northeast corner of an intersection and walk around the blocks in a clockwise direction. staff complete the scale for each street of the block, only evaluating the right side of the street. thus for each block, three or more assessments are completed. we are in the process of assessing psychometric properties of the instrument, including inter-rater reliability and internal consistency, and determining the minimum number of blocks or street segments that need to be assessed in order to provide an accurate estimate of the neighborhood environment. these data will be presented at the conference. obj«tive: to describe and analyze the perceptions of longterm injection drug users (idus) about their initiation into injecting. toronto. purposive sampling was used to seek out an ethnoculturally diverse sample of idus of both genders and from all areas of the city, through recruitment from harm reduction services and from referral by other study participants. interviews asked about drug use history including first use and first injecting, as well as questions about health issues, service utilization and needs. thematic analysis was used to examine initiation of drug use and of injection. results: two conditions appeared necessary for initiation of injection. one was a developed conception of drugs and their (desirable) effects, as suggested by the work of becker for marijuana. thus virtually all panicipants had used drugs by other routes prior to injecting, and had developed expectations about effects they considered pleasureable or beneficial. the second condition was a group and social context in which such use arose. no participants perceived their initiation to injecting as involving peer pressure. rather they suggested that they sought out peers with a similar social situation and interest in using drugs. observing injection by others often served as a means to initiate injection. injection served symbolic purposes for some participants, enhancing their status in their group and marking a transition to a different social world. concl ion: better understanding of social and contextual factors motivating drug users who initiate injection can assist in prevention efforts. ma!onty of them had higher educational level ( %-highschool or higher).about . yo adffiltted to have history of alcohol & another . % had history of smoking. only . % people were on hrt & . % were receiving steroid. majority of them ( . ) did not have history of osteoporosis. . % have difficulty in ambulating. only . % had family history of osteoporosis. bmd measurements as me~sured by dual xray absorptiometry (dexa) were used for the analysis. bmd results were compare~ w ~ rbc folate & serum vitamin b levels. no statistical significance found between bmd & serum v taffiln b level but high levels of folate level is associated with normal bmd in bivariate and multivariate analysis. conclusion: in the studied elderly population, there was no relationship between bmd and vitamin b ; but there was a significant association between folate levels & bmd. introduction: adolescence is a critical period for identity formation. western studies have investigated the relationship of identity to adolescent well-being. special emphasis has been placed on the influence of ethnic identity on health, especially among forced migrants in different foreign countries. methodology: this study asses by the means of an open ended question identity categorization among youth in three economically disadvantaged urban communities in beirut, the capital of lebanon. these three communities have different histories of displacement and different socio-demographic makeup. however, they share a history of displacement due to war. results and conclusion: the results indicated that nationality was the major category of identification in all three communities followed by origin and religion. however, the percentages that self-identify by particular identity categories were significantly different among youth in the three communities, perhaps reflecting different context in which they have grown up. mechanical heart valve replacement amanda hu, chi-ming chow, diem dao, lee errett, and mary keith introduction: patients with mechanical heart valves must follow lifelong warfarin therapy. war· farin, however, is a difficult drug to take because it has a narrow therapeutic window with potential seri· ous side effects. successful anticoagulation therapy is dependent upon the patient's knowledge of this drug; however, little is known regarding the determinants of such knowledge. the purpose of this study was to determine the influence of socioeconomic status on patients' knowledge of warfarin therapy. methods: a telephone survey was conducted among patients to months following mechan· ical heart valve replacement. a previously validated -item questionnaire was used to measure the patient's knowledge of warfarin, its side effects, and vitamin k food sources. demographic information, socioeconomic status data, and medical education information were also collected. results: sixty-one percent of participants had scores indicative of insufficient knowledge of warfarin therapy (score :s; %). age was negatively related to warfarin knowledge scores (r= . , p = . ). in univariate analysis, patients with family incomes greater than $ , , who had greater. than a grade education and who were employed or self employed had significantly higher warfarm knowledge scores (p= . , p= . and p= . respectively). gender, ethnicity, and warfar~n therapy prior to surgery were not related to warfarin knowledge scores. furthermore, none of t~e. m-hospital tea~hing practices significantly influenced warfarin knowledge scores. however, panic ~ants who _rece v~d post discharge co~unity counseling had significantly higher knowledge scores tn comp~r son with those who did not (p= . ). multivariate regression analysis revealed that und~r~tandmg the ~oncept of ?ternational normalized ratio (inr), knowing the acronym, age and receiving ~ommum !' counseling after discharge were the strongest predictors of warfarin kn~wledge. s~ oeconom c status was not an important predictor of knowledge scores on the multivanate analysis. poster sessions v ~the majority of patients at our institution have insufficient knowledge of warfarin therapy.post-discharge counseling, not socioeconomic status, was found to be an important predictor of warfarin knowledge. since improved knowledge has been associated with improved compliance and control, our findings support the need to develop a comprehensive post-discharge education program or, at least, to ensure that patients have access to a community counselor to compliment the in-hospital educatiop program. brenda stade, tony barozzino, lorna bartholomew, and michael sgro lnttotl#ction: due to the paucity of prospective studies conducted and the inconsistency of results, the effects of prenatal cocaine exposure on functional abilities during childhood remain unclear. unlike the diagnosis of fetal alcohol spectrum disorder, a presentation of prenatal cocaine exposure and developmental and cognitive disabilities does not meet the criteria for specialized services. implications for public policy and services are substantial. objective: to describe the characteristics of children exposed to cocaine during gestation who present to an inner city specialty clinic. mnbods: prospective cohort research design. sample and setting: children ages to years old, referred to an inner city prenatal substance exposure clinic since november, . data collection: data on consecutive children seen in the clinic were collected over an month period. instrument: a thirteen ( ) page intake and diagnostic form, and a detailed physical examination were used to collect data on prenatal substance history, school history, behavioral problems, neuro-psychological profile, growth and physical health of each of the participants. data analysis: content analysis of the data obtained was conducted. results: twenty children aged to years (mean= . years) participated in the study. all participants had a significant history of cocaine exposure and none had maternal history or laboratory (urine, meconium or hair) exposure to alcohol or other substances. none met the criteria of fetal alcohol spectrum disorder. all were greater than the tenth percentile on height, weight, and head circumference, and were physically healthy. twelve of the children had iqs at the th percentile or less. for all of the children, keeping up with age appropriate peers was an ongoing challenge because of problems in attention, motivation, motor control, sensory integration and expressive language. seventy-four percent of participants had significant behavioral and/or psychological problems including aggressiveness, hyperactivity, lying, poor peer relationships, extreme anxiety, phobias, and poor self-esteem. conclusion: pilot study results demonstrated that children prenatally exposed to cocaine have significant learning, behavioural, and social problems. further research focusing on the characteristics of children prenatally exposed to cocaine has the potential for changing policy and improving services for this population. methods: trained interviewers conducted anonymous quantitative surveys with a random sample (n= ) of female detainees upon providing informed consent. the survey focused on: sociodemographic background; health status; housing and neighborhood stability and social resource availability upon release. results: participants were % african-american, % white, % mixed race and % native american. participants' median age was , the reported median income was nto area. there is mounting evidence that the increasing immigrant population has a_ sigmfic~nt health disadvantage over canadian-born residents. this health disadvantage manifests particularly m the ma "ority of "mm "gr t h h d be · · h . . . . an s w o a en m canada for longer than ten years. this group as ~n associ~te~ with higher risk of chronic disease such as cardiovascular diseases. this disparity twccb n ma onty of the immigrant population and the canadian-born population is of great importance to ur an health providers d" · i i · b as isproporttonate y arge immigrant population has settled in the ma or ur an centers. generally the health stat f · · · · · · h h been . us most mm grants s dynamic. recent mm grants w o av_e ant •;ffca~ada _for less ~han ~en years are known to have a health advantage known as 'healthy imm • ~ants r::r · ~:s eff~ ~ defined by the observed superior health of both male and female recent immi- immigrant participation in canadian society particularly the labour market. a new explanation of the loss of 'healthy immigrant effect' is given with the help of additional factors. lt appears that the effects of social exclusion from the labour market leading to social inequalities first experienced by recent immigrant has been responsible for the loss of healthy immigrant effect. this loss results in the subsequent health disadvantage observed in the older immigrant population. a study on patients perspectives regarding tuberculosis treatment by s.j.chander, community health cell, bangalore, india. introduction: the national tuberculosis control programme was in place over three decades; still tuberculosis control remains a challenge unmet. every day about people die of tuberculosis in india. tuberculosis affects the poor more and the poor seek help from more than one place due to various reasons. this adversely affects the treatment outcome and the patient's pocket. many tuberculosis patients become non-adherence to treatment due to many reasons. the goal of the study was to understand the patient's perspective regarding tuberculois treatment provided by the bangalore city corporation. (bmc) under the rntcp (revised national tuberculosis control programme) using dots (directly observed treatment, short course) approach. bmc were identified. the information was collected using an in-depth interview technique. they were both male and female aged between - years suffering from pulmonary and extra pulmonary tuberculosis. all patients were from the poor socio economic background. results: most patients who first sought help from private practitioners were not diagnosed and treated correctly. they sought help form them as they were easily accessible and available but they. most patients sought help later than four weeks as they lacked awareness. a few of patients sought help from traditional healers and magicians, as it did not help they turned to allopathic practitioners. the patients interviewed were inadequately informed about various aspect of the disease due to fear of stigma. the patient's family members were generally supportive during the treatment period there was no report of negative attitude of neighbours who were aware of tuberculosis patients instead sympathetic attitude was reported. there exists many myth and misconception associated with marriage and sexual relationship while one suffers from tuberculosis. patients who visited referral hospitals reported that money was demanded for providing services. most patients had to borrow money for treatment. patients want health centres to be clean and be opened on time. they don't like the staff shouting at them to cover their mouth while coughing. conclusion: community education would lead to seek help early and to take preventive measures. adequate patient education would remove all myth and conception and help the patients adhere to treatment. since tb thrives among the poor, poverty eradiation measures need to be given more emphasis. mere treatment approach would not help control tuberculosis. lntrod#ction: the main causative factor in cervical cancer is the presence of oncogenic human papillomavitus (hpv). several factors have been identified in the acquisition of hpv infection and cervical cancer and include early coitarche, large number of lifetime sexual partners, tobacco smoking, poor diet, and concomitant sexually transmitted diseases. it is known that street youth are at much higher risk for these factors and are therefore at higher risk of acquiring hpv infection and cervical cancer. thus, we endeavoured to determine the prevalence of oncogenic hpv infection, and pap test abnormalities, in street youth. ~tbods: this quantitative study uses data collected from a non governmental, not for profit dropin centre for street youth in canada. over one hundred females between the ages of sixteen and twentyfour were enrolled in the study. of these females, all underwent pap testing about those with a previous history of an abnormal pap test, or an abnormal-appearing cervix on clinical examination, underwent hpv-deoxyribonucleic (dna) testing with the digene hybrid capture ii. results: data analysis is underway. the following results will be presented: ) number of positive hpv-dna results, ) pap test results in this group, ) recommended follow-up. . the results of this study will provide information about the prevalence of oncogemc hpv-dna infection and pap test abnormalities in a population of street youth. the practice implic~ tions related to our research include the potential for improved gynecologic care of street youth. in addition, our recommendations on the usefulness of hpv testing in this population will be addressed. methods: a health promotion and disease prevention tool was developed over a period of several years to meet the health needs of recent immigrants and refugees seen at access alliance multicultural community health centre (aamchc), an inner city community health centre in downtown toronto. this instrument was derived from the anecdotal experience of health care providers, a review of medical literature, and con· sultations with experts in migration health. herein we present the individual components of this instrument, aimed at promoting health and preventing disease in new immigrants and refugees to toronto. results: the health promotion and disease prevention tool for immigrants focuses on three primary health related areas: ) globally important infectious diseases including tuberculosis (tb), hiv/aids, syphilis, viral hepatitis, intestinal parasites, and vaccine preventable diseases (vpd), ) cancers caused by infectious diseases or those endemic to developing regions of the world, and ) mental illnesses includiog those developing among survivors of torture. the health needs of new immigrants and refugees are complex, heterogeneous, and ohen reflect conditions found in the immigrant's country of origin. ideally, the management of all new immigrants should be adapted to their experiences prior to migration, however the scale and complexity of this strategy prohibits its general use by healthcare providers in industrialized countries. an immigrant specific disease prevention instrument could help quickly identify and potentially prevent the spread of dangerous infectious diseases, detect cancers at earlier stages of development, and inform health care providers and decision makers about the most effective and efficient strategies to prevent serious illness in new immigrants and refugees. lntrodmction: as poverty continues to grip pakistan, the number of urban street children grows and has now reached alarming proportions, demanding far greater action than presently offered. urbanization, natural catastrophe, drought, disease, war and internal conflict, economic breakdown causing unemployment, and homelessness have forced families and children in search of a "better life," often putting children at risk of abuse and exploitation. objectives: to reduce drug use on the streets in particular injectable drug use and to prevent the transmission of stds/hiv/aids among vulnerable youth. methodology: baseline study and situation assessment of health problems particularly hiv and stds among street children of quetta, pakistan. the program launched a peer education program, including: awareness o_f self and body protection focusing on child sexual abuse, stds/hiv/aids , life skills, gender and sexual rights awareness, preventive health measures, and care at work. it also opened care and counseling center for these working and street children ar.d handed these centers over to local communities. relationships among aids-related knowledge and bt:liefs and sexual behavior of young adults were determined. rea.sons for unsafe sex included: misconception about disease etiology, conflicting cultural values, risk demal, partner pressur~, trust and partner significance, accusation of promiscuity, lack of community endorsement of protecnve measures, and barriers to condom access. in addition socio-economic pressure, physiological issues, poor community participation and anitudes and low ~ducation level limited the effectiveness of existing aids prevention education. according to 'the baseline study the male children are ex~ to ~owledge of safe sex through peers, hakims, and blue films. working children found sexual mfor~anon through older children and their teachers (ustad). recommendation s: it was found that working children are highly vulnerable to stds/hiv/aids, as they lack protective meas":res in sexual abuse and are unaware of safe sexual practices. conclusion: non-fatal overdose was a common occurrence for idu in vancouver, and was associated with several factors considered including crystal methamphetamine use. these findings indicate a need for structural interventions that seek to modify the social and contextual risks for overdose, increased access to treatment programs, and trials of novel interventions such as take-home naloxone programs. background: injection drug users (idus) are at elevated risk for involvement in the criminal justice system due to possession of illicit drugs and participation in drug sales or markets. the criminalization of drug use may produce significant social, economic and health consequences for urban poor drug users. injection-related risks have also been associated with criminal justice involvement or risk of such involvement. previous research has identified racial differences in drug-related arrests and incarceration in the general population. we assess whether criminal justice system involvement differs by race/ethnicity among a community sample of idus. we analyzed data collected from idus (n = , ) who were recruited in san francisco, and interviewed and tested for hiv. criminal justice system involvement was measured by arrest, incarceration, drug felony, and loss/denial of social services associated with the possession of a drug felony. multivariate analyses compared measures of criminal justice involvement and race/ethnicity after adjusting for socio-demographic and drug-use behaviors including drug preference, years of injection drug use, injection frequency, age, housing status, and gender. the six-month prevalence of arrest was highest for whites ( %), compared to african americans ( %) and latinos ( % ), in addition to the mean number of weeks spent in jail in the past months ( . vs. . and . weeks). these differences did not remain statistically significant in multivariate analyses. latinos reported the highest prevalence of a lifetime drug felony conviction ( %) and mean years of lifetime incarceration in prison ( . years), compared to african americans ( %, . years) and whites ( %, . years). being african american was independently associated with having a felony conviction and years of incarceration in prison as compared to whites. the history of involvement in the criminal justice system is widespread in this sample. when looking at racial/ethnic differences over a lifetime including total years of incarceration and drug felony conviction, the involvement of african americans in the criminal justice system is higher as compared to whites. more rigorous examination of these data and others on how criminal justice involvement varies by race, as well as the implications for the health and well-being of idus, is warranted. homelessness is a major social concern that has great im~act on th~se living.in urban commu?ities. metro manila, the capital of the philippines is a highly urbanized ar~ w. t~ the h gh~st concentration of urban poor population-an estimated , families or , , md v duals. this exploratory study v is the first definitive study done in manila that explores the needs and concerns of street dwdlent\omc. less. it aims to establish the demographic profile, lifestyle patterns and needs of the streetdwdlersindit six districts city of manila to establish a database for planning health and other related interventions. based on protocol-guid ed field interviews of street dwellers, the data is useful as a template for ref!!. ence in analyzing urban homelessness in asian developing country contexts. results of the study show that generally, the state of homelessness reflects a feeling of discontent, disenfranchisem ent and pow!!· lessness that contribute to their difficulty in getting out of the streets. the perceived problems andlar dangers in living on the streets are generally associated with their exposure to extreme weather condirioll! and their status of being vagrants making them prone to harassment by the police. the health needs of the street dweller respondents established in this study indicate that the existing health related servias for the homeless poor is ineffective. the street dweller respondents have little or no access to social and health services, if any. some respondents claimed that although they were able to get service from heallh centers or government hospitals, the medicines required for treatment are not usually free and are beyond their means. this group of homeless people needs well-planned interventions to hdp them improve their current situations and support their daily living. the expressed social needs of the sucet dweller respondents were significantly concentrated on the economic aspect, which is, having a perma· nent source of income to afford food, shelter, clothing and education. these reflect the street dweller' s need for personal upliftment and safety. in short, most of their expressed need is a combination of socioeconomic resources that would provide long-term options that are better than the choice of living on the streets. the suggested interventions based on the findings will be discussed. . methods: idu~ aged i and older who injected drugs within the prior month were recruited in usmg rds which relies on referral networks to generate unbiased prevalence estimates. a diverse and mon· vated g~o~p of idu "seeds." were given three uniquely coded coupons and encouraged to refer up to three other ehgibl~ idu~, for which they received $ usd per recruit. all subjects provided informed consent, an anonymous ~t erv ew and a venous blood sample for serologic testing of hiv, hcv and syphilis anti~!· results. a total of idus were recruited in tijuana and in juarez, of whom the maion!)' were .male < .l. % and . %) and median age was . melhotls: using the data from a multi-site survey on health and well being of a random sample of older chinese in seven canadian cities, this paper examined the effects of size of the chinese community and the health status of the aging chinese. the sample (n= , ) consisted of aging chinese aged years and older. physical and mental status of the participants was measured by a chinese version medical outcome study short form sf- . one-way analysis of variance and post-hoc scheffe test were used to test the differences in health status between the participants residing in cities representing three different sizes of the chinese community. regression analysis was also used to examine the contribution of size of the chinese community to physical and mental health status. rmdts: in general, aging chinese who resided in cities with a smaller chinese population were healthier than those who resided in cities with a larger chinese population. the size of the chinese community was significant in predicting both physical and mental health status of the participants. the findings also indicated the potential underlying effects of the variations in country of origin, access barriers, and socio-economic status of the aging chinese in communities with different chinese population size. the study concluded that size of an ethnic community affected the health status of the aging population from the same ethnic community. the intra-group diversity within the aging chinese identified in this study helped to demonstrate the different socio-cultural and structural challenges facing the aging population in different urban settings. urban health and demographic surveillance system, which is implemented by the african population & health research center (aphrc) in two slum settlements of nairobi city. this study focuses on common child illnesses including diarrhea, fever, cough, common cold and malaria, as well as on curative health care service utilization. measures of ses were created using information collected at the household level. other variables of interest included are maternal demographic and cultural factors, and child characteristics. statistical methods appropriate for clustered data were used to identify correlates of child morbidity. preliminary ratdts: morbidity was reported for , ( . %) out of , children accounting for a total of , illness episodes. cough, diarrhoea, runny nose/common cold, abdominal pains, malaria and fever made up the top six forms of morbidity. the only factors that had a significant associ· ation with morbidity were the child's age, ethnicity and type of toilet facility. however, all measures of socioeconomic status (mother's education, socioeconomic status, and mother's work status) had a significant effect on seeking outside care. age of child, severity of illness, type of illness and survival of father and mother were also significantly associated with seeking health care outside home. the results of this study have highlighted the need to address environmental conditions, basic amenities, and livelihood circumstances to improve child health in poor communities. the fact that socioeconomic indicators did not have a significant effect on prevalence of morbidity but were significant for health seeking behavior, indicate that while economic resources may have limited effect in preventing child illnesses when children are living in poor environmental conditions, being enlightened and having greater economic resources would mitigate the impact of the poor environmental conditions and reduce child mortality through better treatment of sick children. inequality in human life chances is about the most visible character of the third world urban space. f.conomic variability and social efficiency have often been fingered to justify such inequalities. within this separation households exist that share similar characteristics and are found to inhabit a given spatial unit of the 'city. the residential geography of cities in the third world is thus characterized by native areas whose core is made up of deteriorated slum property, poor living conditions and a decayed environment; features which personify deprivation in its unimaginable ma~t~de. there are .eviden~es that these conditions are manifested through disturbingly high levels of morbidity and mortality. ban · h h d-and a host of other factors (corrupt n, msens t ve leaders p, poor ur ty on t e one an , . · f · · · th t ) that suggest cracks in the levels and adherence to the prmc p es o socta usnce. ese governance, e c . . . . . ps £factors combine to reinforce the impacts of depnvat n and perpetuate these unpacts. by den· grou o . · "id . . bothh tifying health problems that are caused or driven by either matena _or soc a e~nvanon or , t e paper concludes that deprivation need not be accepted as a way. of hfe a~d a deliberate effon must be made to stem the tide of the on going levels of abject poverty m the third world. to the extent that income related poverty is about the most important of all ramifications of po~erty, efforts n_iu_st include fiscal empowerment of the poor in deprived areas like the inner c~ty. this will ~p~ove ~he willingness of such people to use facilities of care because they are able to effectively demand t, smce m real sense there is no such thing as free medical services. ). there were men with hiv-infection included in the present study (mean age and education of . (sd= . ) and . (sd= . ), respectively). a series of multiple regressions were used to examine the unique contributions of symptom burden (depression, cognitive, pain, fatigue), neuropsychologic al impairment (psychomotor efficiency), demographics (age and education) and hiv disease (cdc- staging) on iirs total score and jirs subscores: ( ) activities of daily living (work, recreation, diet, health, finances); ( ) psychosocial functioning (e.g., self-expression, community involvement); and ( ) intimacy (sex life and relationship with partner). resnlts: total iirs score (r " . ) was associated with aids diagnosis (ii= . , p < . ) and symptoms of pain (ii= - . , p < . ), fatigue (ji = - . , p < . ) and cognitive difficulties (p = . , p < . ). for the three dimensions of the iirs, multiple regression results revealed: ( ) activities of daily living (r = . ) were associated with aids diagnosis (ii = . , p < . ) and symptoms of pain

mg/di) on dipstick analysis. results: there were , ( . %) males. racial distribution was chinese ( . % ), malay ( . % ), indians ( . %) and others ( . % ).among participants, who were apparently "healthy" (asymptomatic and without history of dm, ht, or kd), gender and race wise % prevalence of elevated (bp> / ), rbg (> mg/di) and positive urine dipstick for protein was as follows male: ( . ; . ; . ) female:( . ; . ; . ) chinese:( . ; . ; ) malay: ( . ; . ; . ) indian:( . ; . ; . ) others: ( . ; . ; . ) total:(l . , . , . ). percentage of participants with more than one abnormality were as follows. those with bp> / mmhg, % also had rbg> mg/dl and . % had proteinuria> i. those with rbg> mgldl, % also had proteinuria> and % had bp> / mmhg. those with proteinuria> , % also had rbg> mg/dl, and % had bp> / mmhg. conclusion: we conclude that sub clinical abnormalities in urinalysis, bp and rbg readings are prevalent across all genders and racial groups in the adult population. the overlap of abnormalities, point towards the high risk for esrd as well as cardiovascular disease. this indicates the urgent need for population based programs aimed at creating awareness, and initiatives to control and retard progression of disease. introduction: various theories have been proposed that link differential psychological vulnerability to health outcomes, including developmental theories about attachment, separation, and the formation of psychopathology. research in the area of psychosomatic medicine suggests an association between attachment style and physical illness, with stress as a mediator. there are two main hypotheses explored in the present study: ( t) that individuals living with hiv who were upsychologically vulne~able" at study entry would be more likely to experience symptoms of depression, anxiety and phys ca! illness over. the course of the -month study period; and ( ) life stressors and social support would mediate the relat nship between psychological vulnerability and the psychological ~nd physical outcomes. . (rsles), state-trait anxiety inventory (stai), beck depr~ssi~n lnvento~ (bdi), and~ _ -item pbys~i symptoms inventory. we characterized participants as havmg psychological vulnerability and low resilience" as scoring above on the raas (insecure attachment) or above on the das (negative expectations about oneself). . . . . . " . . ,, . results: at baseline, % of parnc pants were classified as havmg low resilience. focusmg on anxiety, the average cumulative stai score of the low-resilience group was significandy hi~e~ than that of the high-resilience group ( . sd= . versus . sd= . ; f(l, )= . , p <. ). similar results were obtained for bdi and physical symptoms (f( , )= . , p<. and f( , )= . , p<. , respec· tively). after controlling for resilience, the effects of variance in life stres".°rs averaged over time wa~ a_sig· nificant predictor of depressive and physical symptoms, but not of anxiety. ho~e_ver, these assooan~s became non-significant when four participants with high values were removed. s id larly, after controlling for resilience, the effects of variance in social support averaged over time became insignificant. conclusion: not only did "low resilience" predict poor psychological and physical outcomes, it was also predictive of life events and social support; that is, individuals who were low in resilience were more likely to experience more life events and poorer social support than individuals who were resilient. for individuals with vulnerability to physical, psychological, and social outcomes, there is need to develop and test interventions to improve health outcomes in this group. rajat kapoor, ruby gupta, and jugal kishore introduction: young people in india represent almost one-fourth of the total population. they face significant risks related to sexual and reproductive health. many lack the information and skills neces· sary to make informed sexual and reproductive health choices. objective: to study the level of awareness about contraceptives among youth residing in urban and rural areas of delhi. method: a sample of youths was selected from barwala (rural; n= ) and balmiki basti (urban slums; n= ) the field practice areas of the department of community medicine, maulana azad medical college, in delhi. a pre-tested questionnaire was used to collect the information. when/(calen· dar time), by , fisher exact and t were appliedxwhom (authors?). statistical tests such as as appropriate. result: nearly out of ( . %) youth had heard of at least one type of contraceptive and majority ( . %) had heard about condoms. however, awareness regarding usage of contraceptives was as low as . % for terminal methods to . % for condom. condom was the best technique before and after marriage and also after childbirth. the difference in rural and urban groups was statistically signif· icant (p=. , give confidence interval too, if you provide the exact p value). youth knew that contra· ceptives were easily available ( %), mainly at dispensary ( . %) and chemist shops ( . %). only . % knew about emergency contraception. only advantage of contraceptives cited was population con· trol ( . %); however, . % believed that they could also control hiv transmission. awareness of side effects was poor among both the groups but the differences were statistically significant for pills (p= . ). media was the main source of information ( %). majority of youth was willing to discuss a~ut contraceptive with their spouse ( . %), but not with others. . % youth believed that people in their age group use contraceptives. % of youth accepted that they had used contraceptives at least once. % felt children in family is appropriate, but only . % believed in year spacing. . conclusion: awareness about contraceptives is vital for youth to protect their sexual and reproduc· tive health .. knowledge about terminal methods, emergency contraception, and side effects of various contraceptives need to be strengthened in mass media and contraceptive awareness campaigns. mdbot:ls: elderly aged + were interviewed in poor communities in beirut the capital of f:ebanon, ~e of which is a palestinia~. refugee camp. depression was assessed using the i -item geriat· nc depressi~n score (~l?s- ). specific q~estions relating to the aspects of religiosity were asked as well as questions perta rung to demographic, psychosocial and health-related variables. results: depression was prevalent in % of the interviewed elderly with the highest proportion being in the palestinian refugee camp ( %). mosque attendance significantly reduced the odds of being depressed only for the palestinian respondents. depression was further associated, in particular communities, with low satisfaction with income, functional disability, and illness during last year. condiuion: religious practice, which was only related to depression among the refugee population, is discussed as more of an indicator of social cohesion, solidarity than an aspect of religiosity. furthermore, it has been suggested that minority groups rely on religious stratagems to cope with their pain more than other groups. implications of findings are discussed with particular relevance to the populations studied. nearly thirty percent of india's population lives in urban areas. the outcome of urbanization has resulted in rapid growth of urban slums. in a mega-city chennai, the slum populations ( . percent) face greater health hazards due to overcrowding, poor sanitation, lack of access to safe drinking water and environmental pollution. amongst the slum population the health of women and children are most neglected, resulting in burden of both communicable and non-communicable diseases. the focus of the paper is to present the epidemiology profile of children (below years) in slums of chennai, their health status, hygiene and nutritional factors, the social response to health, the trends in child health and urbanization over a decade, the health accessibility factors, the role of gender in health care and assessment impact of health education to children. the available data prove that child health in slums is worse than rural areas. though the slum population is decreasing there is a need to explore the program intervention and carry out surveys for collecting data on some specific health implications of the slum children. objective: during the summer of there was a heat wave in central europe, producing an excess number of deaths in many countries including spain. the city of barcelona was one of the places in spain where temperatures often surpassed the excess heat threshold related with an increase in mortality. the objective of the study was to determine whether the excess of mortality which occurred in barcelona was dependent on age, gender or educational level, important but often neglected dimensions of heat wave-related studies. methods: barcelona, the second largest city in spain ( , , inhabitants in ) , is located on the north eastern coast. we included all deaths of residents of barcelona older than years that occurred in the city during the months of june, july and august of and also during the same months during the preceding years. all the analyses were performed for each sex separately. the daily number of deaths in the year was compared with the mean daily number of deaths for the period - for each educational level. poisson regression models were fitted to obtain the rr of death in with respect to the period - for each educational level and age group. results: the excess of mortality during that summer was more important for women than for men and among older ages. although the increase was observed in all educational groups, in some age-groups the increase was larger for people with less than primary education. for example, for women in the group aged - , the rr of dying for compared to - for women with no education was . ( %ci: . - - ) and for women with primary education or higher was . ( %ci: . - . ). when we consider the number of excess deaths, for total mortality (>= years) the excess numbers were higher for those with no education ( . for women and . for men) and those with less than primary education ( . for women and - for men) than those with more than primary edm:ation ( . for women and - . for men). conclusion: age, gender and educational level were important in the barcelona heat wave. it is necessary to implement response plans to reduce heat morbidity and mortality. policies should he addressed to all population but also focusing particularly to the oldest population of low educational level. introduction: recently there has been much public discourse on homelessness and its imp~ct on health. measures have intensified to get people off the street into permanent housing. for maximum v poster sessions success it is important to first determine the needs of those to be housed. their views on housing and support requirements have to be considered, as th~y ar~ the ones affected. as few res.earch studies mclude the perspectives of homeless people themselves, httle is known on ho~ they e~penence the mpacrs on their health and what kinds of supports they believe they need to obtain housing and stay housed. the purpose of this study was to add the perspectives of homeless people to the discourse, based in the assumption that they are the experts on their own situations and needs. housing is seen as a major deter· minant of health. the research questions were: what are the effects of homelessness on health? what kind of supports are needed for homeless people to get off the street? both questions sought the views of homeless individuals on these issues. methods: this study is qualitative, descriptive, exploratory. semi-structured interviews were conducted with homeless persons on street corners, in parks and drop-ins. subsequently a thematic analysis was carried out on the data. results: the findings show that individuals' experiences of homelessness deeply affect their health. apart from physical impacts all talked about how their emotional health and self-esteem are affected. the system itself, rather than being useful, was often perceived as disabling and dehumanizing, resulting in hopelessness and resignation to life on the street. neither welfare nor minimum wage jobs are sufficient to live and pay rent. educational upgrading and job training, rather than enforced idleness, are desired by most initially. in general, the longer persons were homeless, the more they fell into patterned cycles of shelter /street life, temporary employment /unemployment, sometimes addictions and often unsuccessful housing episodes. conclusions: participants believe that resources should be put into training and education for acquisition of job skills and confidence to avoid homelessness or minimize its duration. to afford housing low-income people and welfare recipients need subsidies. early interventions, 'housing first', more humane and efficient processes for negotiating the welfare system, respectful treatment by service providers and some extra financial support in crisis initially, were suggested as helpful for avoiding homelessness altogether or helping most homeless people to leave the street. this study is a national homelessness initiative funded analysis examining the experiences and perceptions of street youth vis-a-vis their health/wellness status. through in-depth interviews with street youth in halifax, montreal, toronto, calgary, ottawa and vancouver, this paper explores healthy and not-so healthy practices of young people living on the street. qualitative interviews with health/ social service providers complement the analysis. more specifically, the investigation uncovers how street youth understand health and wellness; how they define good and bad health; and their experiences in accessing diverse health services. findings suggest that living on the street impacts physical, emotional and spiritual well·being, leading to cycles of despair, anger and helplessness. the majority of street youth services act as "brokers" for young people who desire health care services yet refuse to approach formal heal~h care organizational structures. as such, this study also provides case examples of promising youth services across canada who are emerging as critical spaces for street youth to heal from the ravages of ~treet cultur~. as young people increasingly make up a substantial proportion of the homeless population in canada, it becomes urgent to explore the multiple ways in which we can support them to regain a sense of wellbeing and "citizenship." p - (c) health and livelihood implications of marginalization of slum dwellers in provision of water and sanitation services in nairobi city elizabeth kimani, eliya zulu, and chi-chi undie . ~ntrodfldion: un-habitat estimates that % of urban residents in kenya live in slums; yet due to their illegal status, they are not provided with basic services such as water sanitation and health care. ~nseque~tly, the services are provided by vendors who typically provide' poor services at exorbitant prices .. this paper investigates how the inequality in provision of basic services affects health and livelihood circumstances of the poor residents of nairobi slums . . methods: this study uses qualitative and quantitative data collected through the ongoing longitudmal .health and demographic study conducted by the african population and health research center m slum communities in n ·rob" w d · · · · ai . e use escnpnve analytical and qualitative techmques to assess h~w concerns relating to water supply and environmental sanitation services rank among the c~mmumty's general and health needs/concerns, and how this context affect their health and livelihood circumstances. results: water ( %) and sanitation ( %) were the most commonly reported health needs and also key among general needs (after unemployment) among slum dwellers. water and sanitation services are mainly provided by exploitative vendors who operate without any regulatory mechanism and charge exorbitantly for their poor services. for instance slum residents pay about times more for water than non-slum households. water supply is irregular and residents often go for a week without water; prices are hiked and hygiene is compromised during such shortages. most houses do not have toilets and residents have to use commercial toilets or adopt unorthodox means such as disposing of their excreta in the nearby bushes or plastic bags that they throw in the open. as a direct result of the poor environmental conditions and inaccessible health services, slum residents are not only sicker, they are also less likely to utilise health services and consequently, more likely to die than non-slum residents. for instance, the prevalence of diarrhoea among children in the slums was % compared to % in nairobi as a whole and % in rural areas, while under-five mortality rates were / , / and / respectively. the results demonstrate the need for change in governments' policies that deprive the rapidly expanding urban poor population of basic services and regulatory mechanisms that would protect them from exploitation. the poor environmental sanitation and lack of basic services compound slum residents' poverty since they pay much more for the relatively poor services than their non-slum counterparts, and also increase their vulnerability to infectious diseases and mortality. since iepas've been working in harm reduction becoming the pioneer in latin america that brought this methodology for brazil. nowadays the main goal is to expand this strategy in the region and strive to change the drug policy in brazil. in this way harm reduction: health and citizenship program work in two areas to promote the citizenship of !du and for people living with hiv/aids offering law assistance for this population and outreach work for needle exchange to reduce damages and dissemination of hiv/aids/hepatit is. the methodology used in outreach work is peer education, needle exchange, condoms and folders distribution to reduce damages and the dissemination of diseases like hiv/aids/hepatitis besides counseling to search for basic health and rights are activities in this program. law attendance for the target population at iepas headquarters every week in order to provide law assistance that includes only supply people with correct law information or file a lawsuit. presentations in harm reduction and drug policy to expand these subjects for police chiefs and governmental in the last year attended !du and nidu reached and . needles and syringes exchanged. in law assistance ( people living with aids, drug users, inject drug users, were not in profile) people attended. lawsuits filed lawsuits in current activity. broadcasting of the harm reduction strategies by the press helps to move the public opinion, gather supporters and diminish controversies regarding such actions. a majority number of police officer doesn't know the existence of this policy. it's still polemic discuss this subject in this part of population. women remain one of the most under seviced segments of the nigerian populationand a focus on their health and other needs is of special importance.the singular focus of the nigerian family welfare program is mostly on demographic targets by seeking to increase contraceptive prevalence.this has meant the neglect of many areas of of women's reproductive health. reproductive health is affected by a variety of socio-cultural and biological factors on on e hand and the quality of the service delivery system and its responsiveness on the other.a woman's based approach is one which responds to the needs of the adult woman and adolescent girls in a culturally sensitive manner.women's unequal access to resources including health care is well known in nigeria in which stark gender disparities are a reality .maternal health activities are unbalanced,focusi ng on immunisation and provision of iron and folic acid,rather than on sustained care of women or on the detection and referral of high risk cases. a cross-sectional study of a municipal government -owned hospitalfrom each of the geo-political regions in igeria was carried out (atotal of ce~ters) .. as _part ~f t~e re.search, the h~spital records were uesd as a background in addition to a -week mtens ve mvesuganon m the obstemc and gynecology departments. . . . : little is known for example of the extent of gynecological morbtdtty among women; the little known suggest that teh majority suffer from one or more reproductive tr~ct infect~ons. although abortion is widespread, it continues to be performed under ilegal and unsafe condmons. with the growing v poster sessions hiv pandemic, while high riskgroups such ascomn;iercial sex workers and their clients have been studied, little has been accomplished in the large populat ns, and particularly among women, regardmgstd an hiv education. . . conclusions: programs of various governmentalor non-governmental agen,c es to mvolve strategies to broaden the narrow focus of services, and more importan~, to put wo~en s reproducnve health services and information needs in the forefront are urgently required. there is a n~d to reonent commuication and education activities to incorprate a wider interpretation of reproducnve health, to focus on the varying information needs of women, men, and youth and to the media most suitable to convey information to these diverse groups on reproductive health. introduction: it is estimated that there are - youths living on the streets, on their own with the assistance of social services or in poverty with a parent in ottawa. this population is under-serviced in many areas including health care. many of these adolescents are uncomfortable or unable to access the health care system through conventional methods and have been treated in walk-in clinics and emergency rooms without ongoing follow up. in march , the ontario government provided the ct lamont institute with a grant to open an interdisciplinary and teaching medical/dental clinic for street youth in a drop-in center in downtown ottawa. bringing community organizations together to provide primary medical care and dental hygiene to the streetyouths of ottawa ages - , it is staffed by a family physician, family medicine residents, a nurse practitioner, public health nurses, a dental hygienist, dental hygiene students and a chiropodist who link to social services already provided at the centre including housing, life skills programs and counselling. project objectives: . to improve the health of high risk youth by providing accessible, coordinated, comprehensive health and dental care to vulnerable adolescents. . to model and teach interdisciplinary adolescent care to undergraduate medical students, family medicine residents and dental hygiene students. methods: non-randomized, mixed method design involving a process and impact evaluation. data collection-qualitative:a) semi-structured interviews b) focus groups with youth quantitative:a) electronic medical records for months b) records (budget, photos, project information). results: in progress-results from first months available in august . early results suggest that locating the clinic in a safe and familiar environment is a key factor in attracting the over youths the clinic has seen to date. other findings include the prevalence of preventative interventions including vaccinations, std testing and prenatal care. the poster presentation will present these and other impacts that the clinic has had on the health of the youth in the first year of the study. conclusions: ) the clinic has improved the health of ottawa streetyouth and will continue beyond the initial pilot project phase. ) this project demonstrates that with strong community partnerships, it is possible meet make healthcare more accessible for urban youth. right to health care campaign by s.j.chander, community health cell, bangalore, india. introduction: the people's health movement in india launched a campaign known as 'right to health care' during the silver jubilee year of the alma ata declaration of 'health for all' by ad in collahoration with the national human rights commission (nhrc). the aim of the campaign was to establish the 'right to health care' as a basic human right and to address structural deficiencies in the pubic health care system and unregulated private sector . . methods: as part of the campaign a public hearing was organized in a slum in bangalore. former chairman of the nhrc chaired the hearing panel, consisting of a senior health official and other eminent people in the city. detailed documentation of individual case studies on 'denial of access to health care' in different parts of the city was carried out using a specific format. the focus was on cases where denial of health services has led to loss of life, physical damage or severe financial losses to the patient. results: _fourte_en people, except one who had accessed a private clinic, presented their testimonies of their experiences m accessing the public health care services in government health centres. all the people, e_xcept_ one person who spontaneously shared her testimony, were identified by the organizations worki_ng with the slum dwellers. corruption and ill treatment were the main issues of concern to the people. five of the fourteen testimonies presented resulted in death due to negligence. the public health cen· n:s not only demand money for the supposedly free services but also ill-treats them with verbal abuse. five of these fourteen case studies were presented before the national human right commission. the poster sessions v nhrc has asked the government health officials to look into the cases that were presented and to rectify the anomalies in the system. as a result of the public hearing held in the slum, the nhrc identified urban health as one of key areas for focus during the national public hearing. cond#sion: a campaign is necessary to check the corrupted public health care system and a covetous private health care system. it helps people to understand the structure and functioning of public health care system and to assert their right to assess heath care. the public hearings or people's tribunals held during the campaign are an instrument in making the public health system accountable. ps- (a) violence among women who inject drugs nadia fairbairn, jo-anne stoltz, evan wood, kathy li, julio montaner, and thomas kerr background/object ives: violence is a major cause of morbidity and mortality among women living in urban settings. though it is widely recognized that violence is endemic to inner-city illicit drug markets, little is known about violence experienced by women injection drug users (!du). therefore, the present analyses were conducted to evaluate the prevalence of, and characteristics associated with, experiencing violence among a cohort of female idu in vancouver. methods: we evaluated factors associated with violence among female participants enrolled in the vancouver injection drug user study (vidus) using univariate analyses. we also examined self-reported relationships with the perpetrator of the attack and the nature of the violent attack. results: of the active iou followed between december , and may , , ( . %) had experienced violence during the last six months. variables positively associated with experiencing violence included: homelessness (or= . , % ci: . - . , p < . ), public injecting (or= . , % ci: . - . , p < . ), frequent crack use (or= . , % ci: . - . , p < . ), recent incarceration (or = . , % cl: . - . , p < . ), receiving help injecting (or = . , % cl: . - . , p < . ), shooting gallery attendance (or = . , % ci: . - . , p < . ), sex trade work (or = . , % cl: . - . , p < . ), frequent heroin injection (or= . , % cl: . - . , p < . ), and residence in the downtown eastside (odds ratio [or] = . , % ci: . - . , p < . ). variables negatively associated with experiencing violence included: being married or common-law (or = . . % ci: . - . , p < . ) and being in methadone treatment (or = . , % ci: . - . , p < . ). the most common perpetrators of the attack were acquaintances ( . %), strangers ( . %), police ( . %), or dealers ( . %). attacks were most frequently in the form of beatings ( . %), robberies ( . %), and assault with a weapon ( . %). conclusion: violence was a common experience among women !du in this cohort. being the victim of violence was associated with various factors, including homelessness and public injecting. these findings indicate the need for targeted prevention and support services, such as supportive housing programs and safer injection facilities, for women iou. introduction: although research on determinants of tobacco use among arab youth has been carried out at several ecologic levels, such research has included conceptual models and has compared the two different types of tobacco that are most commonly used among the lebanese youth, namely cigarette and argileh. this study uses the ecological model to investigate differences between the genders as related to the determinants of both cigarette and argileh use among youth. methodology: quantitative data was collected from youth in economically disadvantaged urban communities in beirut, the capital of lebanon. results: the results indicated that there are differences by gender at a variety of ecological levels of influence on smoking behavior. for cigarettes, gender differences were found in knowledge, peer, family, and community influences. for argileh, gender differences were found at the peer, family, and community l.evels. the differential prevalence of cigarette and argileh smoking between boys and girls s therefore understandable and partially explained by the variation in the interpersonal and community envi.ronment which surrounds them. interventions therefore need to be tailored to the specific needs of boys and girls. introduction: the objective of this study was to assess the relationship between parents' employment status and children' health among professional immigrant families in vancouver. our target communmes v poster sessions included immigrants from five ethnicity groups: south korean, indian, chine~e, ~ussian, and irani~ with professional degrees (i.e., mds, lawyers, engineers, ma?~ger~, and uru~ers ty professors) w h no relevant job to their professions and those who had been hvmg m the studied area at least for months. methodology: the participants were recruited by collaboration from three local community agencies and were interviewed individually during the fall of . ra#lts: totally, complete interviews were analyzed: from south-east asia, from south asia, from russia and other eastern europe. overall, . % were employed, . % were underemployed, % indicated they were unemployed. overall, . % were not satisfied with their current job. russians and other eastern europeans were most likely satisfied with their current job, while south-east asians were most satisfied from their life in canada. about % indicated that their spouses were not satisfied with their life in canada, while % believed that their children are very satisfied from their life in canada. in addition, around % said they were not satisfied from their family relationship in canada. while most of the responders ranked their own and their spouses' health status as either poor or very poor, jut % indicated that their first child's health was very poor. in most cases they ranked their children's health as excellent or very good. the results of this pilot study show that there is a need to create culturally specific child health and behavioral scales when conducting research in immigrant communities. for instance, in many asian cultures, it is customary for a parent either to praise their children profusely, or to condemn them. this cultural practice, called "saving face," can affect research results, as it might have affected the present study. necessary steps, therefore, are needed to revise the current standard health and behavioral scales for further studies by developing a new scale that is more relevant and culturally sensitive to the targeted immigrant families. metboda: database: national health survey (ministry of health www.msc.es). two thousand interviews were performed among madrid population ( . % of the whole); corresponded to older adults ( . % of the . million aged years and over). study sample constitutes . % ( out of ) of those older adults, who live in urban areas. demographic structure (by age and gender) of this population in relation to health services use (medical consultations, dentist visits, emergence services, hospitalisation) was studied using general linear model univariate procedure. a p . ), while age was associated with emergence services use ( % of the population: %, % and % of each age group) and hos~italisation ( % .oft~~ population: %, % and %, of each age ~oup) (p . ) was fou~d with respect to dennst v s ts ( % vs %), medical consultations ( % vs %), and emergence services use ( % vs %), while an association (p= . ) was found according to hospitalisation ( % vs %). age. an~ g~der interaction effect on health services use was not found (p> . ), but a trend towards bosp tal sanon (p= . ) could be considered. concl.uions: demographic structure of urban older adults is associated with two of the four health se~ices use studi~. a relation.ship ber_ween age. and hospital services use (emergence units and hospitalisanon), but not with ~ut-hosp tal sei:vices (medical and dentist consultations), was found. in addition ro age, gender also contnbutes to explam hospitalisation. . sexua experiences. we exammed the prevalence expenences relation to ethnic origin and other sociodemographic variables as wc i as y j die relation between unwanted sexual experiences, depression and agreuion. we did so for boys and prts separately. mdhods: data on unwanted sexual expcric:nces, depressive symptoms (ce.s-d), aggrc:uion (bohi-di and sociodemographic facron were collected by self-report quescionnairc:s administettd to students in the: nd grade (aged - ) of secondary schools in amsterdam, the netherlands. data on the nature ol unwanted sexual experiences were collected during penonal interviews by trained schoolnursn. ltaijtj: overall prevalences of unwanted sexual experiences for boys and girls were . % and . % respectively. unwanted sexual experiences were more often ttported by turkish ( . %), moroc· an ( . %) and surinamese/anrillian boys ( . %) than by dutch boys ( . %). moroccan and turkish girls, however, reported fewer unwanted sexual experiences (respectively . and . %) than durch girls did ( . %). depressive symptoms(or= . , cl= . - . ) covert agression ( r• . , cl• . - . ) and cmrt aggression (or= . , cl• . - . ) were more common in girls with an unwanted sexual experi· met. boys with an unwanted sexual experience reported more depressive symptoms (or= . ; cl• i . .l· . ) and oven agression (or= . , cl= . - . ) . of the reported unwanted sexual experiences rnpec· timy . % and . % were confirmed by male and female adolescents during a personal interview. cond sion: we ..:an conclude that the prevalence of unwanted sexual experiences among turkish and moroccan boys is disturbing. it is possible that unwanted sexual experiences are more reported hy boys who belong to a religion or culture where the virginity of girls is a maner of family honour and talking about sexuality is taboo. more boys than girls did not confirm their initial disdosurc of an lllwalltc:d sexual experience. the low rates of disclosure among boys suggcsu a necd to educ.:atc hcahh care providen and others who work with migrant boys in the recognition and repomng of exu.il ... iction. viramin a aupplc:tmntation i at .h'yo, till far from tafl'eted %. feedinit pracn~:n panku· lerty for new born earn demand lot of educatton ernpha a• cxdu ve hrealt fecdtnit for dnared rcnoj of months was observtd in only .s% of childrrn thoulh colckturm w. givm n rn% of mwly horn ct.ildrm. the proportion of children hclow- waz (malnounshrdl .con" a• h!jh •• . % anj "rt'i· acimy tc.. compared to data. mother's ~alth: from all is womm in ttprod~uvr •ill' poup, % were married and among marned w~ .\ % only w\"rt' u mic wmr cnntr.-:cruve mt h· odl % were married bdorc thc •ar of yean and % had thnr ftnc prcicnancy hcftitt dlt' •icr nf yean. the lt'f'vicn are not uutfactory or they arc adequate but nae unh ed opumally. of thote' l'h mothen who had deliverrd in last one year, % had nailed ntmaral eum nat on ira" oncc, .~o-... bad matt rhan four ttmn and ma ortty had heir tetanus toxotd tnin,"t or"'" nlht "'"'"· ljn r ned rn· win ronductrd . % dchvcnn and % had home deh\'t'oc'i. ~md~: the tervtcn unbud or u led are !tu than dnarame. the wr· l'kft provided are inadequate and on dechm reprcwnttng a looun t ~p of h hnto good coytti\#' ol wr· ncn. l!.ckground chanpng pnoriry cannoc be ruled out u °"" of thc coatnbutory bc f. ps-ii ia) dcpn:wioa aad anuccy ia mip'mu ia awccr._ many de wn, witco tui~bmjer. jack dekker, aart·jan lttkman, wim gonmc:n. and amoud verhoeff ~ a dutch commumry-bucd icudy thawed -moarh•·prc:yalm«i al . ' . kw anx · ay daorden and . % foi' dqrasion m anmttdam. nm .. p tficantly hlllhn than dwwhrft .. dw ~thew diffamca m pttyalcnca att probably rdarcd to tlk' largr populanoa of napaan ..\mturdam. ~ddress ~ro.ad~r .determinants of health depends upon the particular health parad'.~ adhered. ~o withm each urisd ctton. and whether a paradigm is adopted depends upon the ideologi~a and pol~ncal context of each nation. nations such as sweden that have a long tradition of public policies promonng social jus~ce an~ equity are naturally receptive to evolving population health concepts. '[he usa represen~ a ~bey en~ro~~t where such is~ues are clear!~ subordinate. ., our findings mdicate that there s a strong political component that influences pubh ~ealth a~proaches and practi~ within the jurisdictions examined. the implications are that those seek· m~ to raise the broader detennmants of the public's health should work in coalition to raise these issues with non-health organizations and age · ca d d th · - badrgrollnd: in developed countries, social inequalities in health have endured or even worsened comparatively throughout different social groups since the s. in france, a country where access to medical and surgical care is theoretically affordable for everyone, health inequalities are among the high· est in western europe. in developing countries, health and access to care have remained critical issues. in madagascar, poverty has even increased in recent years, since the country wenr through political crisis and structural adjustment policies. objectives. we aimed to estimate and compare the impact of socio· economic status but also psychosocial characteristics (social integration, health beliefs, expectations and representation, and psychological characteristics) on the risk of having forgone healthcare in these dif· fercnt contexts. methods: population surveys conducted among random samples of households in some under· served paris neighbourhoods (n= ) and in the whole antananarivo city (n= ) in , using a common individual questionnaire in french and malagasy. reslllts: as expected, the impact of socioeconomic status is stronger in antananarivo than in paris. but, after making adjustments for numerous individual socio-economic and health characteristics, we observed in both cities a higher (and statically significant) occurrence of reponed forgone healthcare among people who have experienced childhood and/or adulthood difficulties (with relative risks up to and .s respectively in paris and antananarivo) and who complained about unhealthy living conditions. in paris, it is also correlated with a lack of trust in health services. coneluions: aside from purely financial hurdles, other individual factors play a role in the non-use of healthcare services. health insurance or free healthcare seems to be necessary hut not sufficienr to achieve an equitable access to care. therefore, health policies must not only focus on the reduction of the financial barriers to healthcare, but also must be supplemented by programmes (e.g. outreach care ser· vices, health education, health promotion programmes) and discretionary local policies tailored to the needs of those with poor health concern .. acknowledgments. this project was supported by the mal>io project and the national institute of statistics (instat) in madagascar, and hy the development research institute (ird) and the avenir programme of the national institute of health and medical research (inserm) in france. for the cities of developing countries, poverty is often described in terms of the living standard~ of slum populations, and there is good reason to believe that the health risks facing these populations are even greater, in some instances, than those facing rural villagers. yet much remains to be learned ahour the connections between urban poverty and health. it is not known what percentage of all urban poor live in slums, that is, in communities of concentrated poverty; neither is it known what proportion of slum residents are, in fact, poor. funhermore, no quantitative accounting is yet available that would sep· arare the health risks of slum life into those due to a househoid•s own poverty and those stemminic from poveny in the surrounding neighborhood. if urban health interventions are to be effectively targeted in developing countries, substantial progress must be made in addressing these cenrral issues. this paper examines poverty and children's health and survival using two large surveys, one a demographic and health survey fielded in urban egypt (with an oversampling of slums) and the other a survey of the slums of allahabad, india. using multivariate statistical methods. we find, in both settings: ( substan· rial evidence of living standards heterogeneity within the slums; ( strong evidence indicating that household-level poverty is an imponant influence on health; and ( ) staristically significant (though less strong) evidence that with household living standards held constant, neighborhood levels of poverty adversely affect health. the paper doses with a discussion of the implications of these findings for the targeting of health and poverty program interventions. p - (a) urban environment and the changing epidemiological surfacr. the cardiovascular ~ &om dorin, nigeria the emergence of cardiovascular diseases had been explained through the concomitants o_f the demographic transition wherein the prevalent causes of morbidity and monality ~hangr pr~mmant infectious diseases to diseases of lifestyle or chronic disease (see deck, ) . a ma or frustration m the v poster sessions case of cvd is its multifactural nature. it is acknowledged that the environment, however defined is the d · f · t' b tween agents and hosts such that chronic disease pathogenesis also reqmre a me an o mterac ion e . spatio-temporal coincidence of these two parties. what is not clear is which among ~ever~( potennal fac· · h b pace exacerbate cvd risk more· and to what extent does the ep dem olog cal trans · tors m t e ur an s ' . . . . tion h othesis relevant in the explanation of urban disease outlook even the developmg cities like nigeri~: thesis paper explorer these within a traditional city in nigeria. . . . the data for the study were obtained from two tertiary level hospitals m the metropolis for years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . the data contain reported cases of cvd in the two facilities for the period. adopting a series of parametric and non-parametric statistics, we draw inferences between the observed cases of cvds and various demographic and locational variables of the patients. findings: about % of rhe cases occurred in years ( ) ( ) ( ) coinciding with the last year of military rule with great instability. . % occurred among male. . % also occurred among people aged - years. these are groups who are also likely to engage in most stressful life patterns. ~e study also shows that % of all cases occurred in the frontier wards with minor city areas also havmg their •fair' share. our result conformed with many empirical observation on the elusive nature of causation of cvd. this multifactoral nature had precluded the production of a map of hypertension that would be consistent with ideas of spatial prediction. cvd -cardiovascular diseases. mumbai is the commercial capital of india. as the hub of a rapidly transiting economy, mumbai provides an interesting case study into the health of urban populations in a developing country. with high-rise multimillion-dollar construction projects and crowded slums next to each other, mumbai presents a con· trast in development. there are a host of hi-tech hospitals which provide high quality care to the many who can afford it (including many westerners eager to jump the queue in their healthcare systems-'medical tour· ism'), at the same time there is a overcrowded and strained public healthcare system for those who cannot afford to pay. voluntary organizations are engaged in service provision as well as advocacy. the paper will outline role of the voluntary sector in the context of the development of the healthcare system in mumbai. mumbai has distinct upper, middle and lower economic classes, and the health needs and problems of all three have similarities and differences. these will be showcased, and the response of the healthcare system to these will be documented. a rising hiv prevalence rate, among the highest in india, is a challenge to the mumbai public healthcare system. the role of the voluntary sector in service provision, advocacy, and empowerment of local populations with regards to urban health has been paramount. the emergence of the voluntary sector as a major player in the puzzle of urban mumbai health, and it being visualized as voices of civil society or communiry representatives has advantages as well as pitfalls. this paper will be a unique attempt at examining urban health in india as a complex web of players. the influence of everyday socio·polirical-cultural and economic reality of the urban mumbai population will be a cross cutting theme in the analysis. the paper will thus help in filling a critical void in this context. the paper will thus map out issues of social justice, gender, equiry, effect of environment, through the lens of the role of the voluntary sector to construct a quilt of the realiry of healthcare in mumbai. the successes and failures of a long tradi· tion of the active advocacy and participation of the voluntary sector in trying to achieve social justice in the urban mumbai community will be analyzed. this will help in a better understanding of global urban health, and m how the voluntary sector/ngos fir into the larger picture. ba~und: o~er. half _of n~irobi's . million inhabitants live in illegal informal settlements that compose yo of the city s res dent al land area. the majority of slum residents lack access to proper san· iranon and a clean and adequate water supply. this research was designed to gain a clearer understand· mg of what kappr · · · h f . . opnate samtanon means or the urban poor, to determine the linkages between gender, hvehhoods, and access to water and sanitation, and to assess the ability of community sanitation blocks to meet water and sanitation needs in urban areas. m~tbojs_: _a household survey, gender specific focus groups and key informant interviews were conducted m maih saba, a peri-urban informal settlement. qualitative and quantitative research tools were u~ to asses~ the impact and effectiveness of community sanitation blocks in two informal settlements. results ropna e samtarmn me u es not only safe and clean latrines, but also provision ° adequate drainage and access to water supply for cleaning of clothes and homes. safety and cleanliness poster sessions v were priorities for women in latrines. levels of poverty within the informal settlements were identified and access to water and sanitation services improved with increased income. environmental health problems related to inadequate water and sanitation remain a problem for all residents. community sanitation blocks have improved the overall local environment and usage is far greater than envisioned in the design phase. women and children use the blocks less than men. this is a result of financial, social, and safety constraints. the results highlight the importance a need to expand participatory approaches for the design of water and sanitation interventions for the urban poor. plans need to recognize "appropriate sanitation" goes beyond provision of latrines and gender and socioeconomic differences must be taken into account. lessons and resources from pilot projects must be learned from, shared and leveraged so that solutions can be scaled up. underlying all the challenges facing improving water and sanitation for the urban poor are issues of land tenure. p - (c) integrating tqm (total quality management), good governance and social mobilization principles in health promotion leadership training programmes for new urban settings in countries/ areas: the prolead experience susan mercado, faren abdelaziz, and dorjursen bayarsaikhan introduction: globalization and urbanization have resulted in "new urban settings" characterized by a radical process of change with positive and negative effects, increased inequities, greater environmental impacts, expanding metropolitan areas and fast-growing slums and vulnerable populations. the key role of municipal health governance in mitigating and modulating these processes cannot be overemphasized. new and more effective ways of working with a wide variety of stakeholders is an underpinning theme for good governance in new urban settings. in relation to this, organizing and sustaining infrastructure and financing to promote health in cities through better governance is of paramount importance. there is a wealth of information on how health promotion can be enhanced in cities. despite this, appropriate capacity building programmes to enable municipal players to effectively respond to the challenges and impacts on health of globalization, urbanization and increasing inequity in new urban settings are deficient. the who kobe centre, (funded by the kobe group( and in collaboration with regional offices (emro, searo, wpro) with initial support from the japan voluntary contribution, developed a health promotion leadership training programme called "prolead" that focuses on new and autonomous structures and sustainable financing for health promotion in the context of new urban settings. methodology: country and/or city-level teams from areas, (china, fiji, india, japan, lebanon, malaysia, mongolia, oman, philippines, republic of korea, tonga and viet nam) worked on projects to advance health promotion infrastructure and financing in their areas over a month period. tools were provided to integrate principles of total quality management, good governance and social mobili .ation. results: six countries/areas have commenced projects on earmarking of tobacco and alcohol taxes for health, moblization of sports and arts organizations, integration of health promotion and social health insurance, organizational reforms, training in advocacy and lobbying, private sector and corporate mobilization and community mobilization. results from the other six areas will be reported in ..;obcr. conclusions: total quality management, good governance and social mobilization principles and skills are useful and relevant for helping municipal teams focus on strategic interventions to address complex and overwhelming determinants of health at the municipal level. the prolead training programmes hopes to inform other processes for building health promotion leadership capacity for new urban settings. the impact of city living and urbanization on the health of citizens in developing countries has received increasing attention in recent years. urban areas contribute largely to national economies. however, rapid and unplanned urban growth is often associated with poverty, environmental degradation and population demands that outstrip service capacity which conditions place human health at risk. local and national governments as well as multi national organizations are all grappling with the challenges of urbanization. with limited data and information available, urban health characteristics, including the types, quantities, locations and sources in kampala, are largely unknown. moreover, there is n? basis for assessing the impact of the resultant initiatives to improve health ~onditions amo~g ~o": ": um ties settled in unplanned areas. since urban areas are more than the aggregation ?f ~?pie w~th md_ v dual risk factors and health care needs, this paper argues that factors beyond the md v dual, mcludmg the poster sessions v · i d h · i · ment and systems of health and social services are determinants of the health soc a an p ys ca environ . of urban populations. however, as part of an ongoing study? ~s pape~ .addresses the basic concerns of urban health in kampala city. while applying the "urban hvmg conditions and the urban heal~ pen· alty" frameworks, this paper use aggregated urban health d~ta t~ explore the role of place an~ st tu· tions in shaping health and well-being of the population m kampala by understanding how characteristics of the urban environment and specific features of the city are causally related to health of invisible and forgotten urban poor population: results i~dica~e that a .range o~ urb~n he~l~h hazards m the city of kampala include substandard housing, crowdmg, mdoor air poll.ut on, msuff c ent a~d con· taminated water, inadequate sanitation and solid waste management services, vector borne .diseases, industrial waste increased motor vehicle traffic among others. the impact of these on the envtronment and community.health are mutually reinforcing. arising out of the withdra"'.al of city pl~nning systems and service delivery systems or just planning failure, thousands of people part cularl~ low-mc~me groups have been pushed to the most undesirable sections of the city where they are faced with ~ va_r ety ~f envj· ronmental insults. the number of initiatives to improve urban health is, however, growing mvolvjng the interaction of many sectors (health, environment, housing, energy, transportation and urban planning) and stakeholders (local government, non governmental organizations, aid donors and local community groups). key words: urban health governance, health risks, kampala. introduction: the viability of urban communities is dependent upon reliable and affordable mass transit. in particular, subway systems play an especially important role in the mass transit network, since they provide service to vast numbers of ridersseven of the subway systems worldwide report over one billion passenger rides each year. surprisingly, given the large number of people potentially affected, very little is known about the health and safety hazards that could affect both passengers and transit workers; these include physical (e.g., noise, vibration, accidents, electrified sources, temperature extremes), biological (e.g., transmission of infectious diseases, either through person-to-person spread or vector-borne, for example, through rodents), chemical (e.g., exposure to toxic and irritant chemicals and metals, gas emissions, fumes), electro-magnetic radiation, and psychosocial (e.g., violence, workstress). more recently, we need to consider the threat of terrorism, which could take the form of a mass casualty event (e.g., resulting from conventional incendiary devices), radiological attack (e.g., "dirty bomb"), chemical terrorist attack (e.g., sarin gas), or bioterrorist attack (e.g., weapons grade anthrax). given the large number of riders and workers potentially at risk, the public health implications are considerable. methods: to assess the hazards associated with subways, a structured review of the (english) litera· ture was conducted. ruults: based on our review, non-violent crime, followed by accidents, and violent crimes are most prevalent. compared to all other forms of mass transit, subways present greater health and safety risks. however, the rate of subway associated fatalities is much lower than the fatality rate associated with automobile travel ( . vs. . per million passenger miles), and cities with high subway ridership rates have a % lower per capita rate of transportation related fatalities than low ridership cities ( . versus . annual deaths per , residents). available data also suggest that subway noise levels and levels of air pollutants may exceed recommended levels. . ~: there is a paucity of published research examining the health and safety hazards associated with subways. most of the available data came from government agencies, who rely on passively reported data. research is warranted on this topic for a number of reasons, not only to address important knowled~ gaps, but also because the population at potential risk is large. importantly, from an urban perspecnve, the benefits of mass transit are optimized by high ridership ratesand these could be adversely affu:ted by unsafe conditions and health and safety concerns. veena joshi, jeremy lim. and benjamin chua ~ ~rban health issues have moved beyond infectious diseases and now centre largely on chrome diseases. diabetes is one of the most prevalent non-communicable diseases globally. % of adult ¥ benefit in providing splash pads in more parks. given the high temperature and humidity of london summers, this is an important aspect and asset of parks. interviewed parents claimed to visit city parks anywhere between to days per week. corrduion: given that the vast majority of canadian children are insufficiently active to gain health benefits, identifying effective qualities of local parks, that may support and foster physical activity is essential. strategies to promote activity within children's environments are an important health initiative. the results from this study have implications for city planners and policy makers; parents' opinions of, and use of city parks provides feedback as to the state current local parks, and modifications that should be made for new ones being developed. this study may also provide important feedback for health promoters trying to advocate for physical activity among children. introdt clion: a rapidly increasing proportion of urban dwellers in africa live below the poverty line in overcrowded slums characterized by uncollected garbage, unsafe water, and deficient sanitation and overflowing sewers. this growth of urban poverty challenges the commonly held assumption that urban populations enjoy better health than their rural counterparts. the objectives of this study are (i) to compare the vaccination status, and morbidity and mortality outcomes among children in the slums of nairobi with rural kenya, and (ii) to examine the factors associated with poor child health in the slums. we use data from demographic and health survey representative of all slum settlements in nairobi city carried out in by the african population & health research center. a total of , women aged - from , households were interviewed. our sample consists of , children aged - months. the comparison data are from the kenya demographic and health survey. the outcomes of interest include child vaccination status, morbidity (diarrhea, fever and cough) and mortality, all dichotomized. socioeconomic, environmental, demographic, and behavioral factors, as well as child and mother characteristics, are included in the multivariate analyses. multilevel logistic regression models are used. l'nlimin ry rest lts: about % of children in the slums had diarrhea in the two weeks prior to the survey, compared to % of rural children. these disparities between the urban poor anj the rural residents are also observed for fever ( % against %), cough ( % versus %), infant mortality ( / against / ), and complete vaccination ( % against %). preliminary multivariate results indicate that health service utilization and maternal education have the strongest predictive power on child morbidity and mortality in the slums, and that household wealth has only minor, statistically insignificant effects. conclruion: the superiority of health of urban children, compared with their rural counterparts, masks significant disparities within urban areas. compared to rural residents, children of slum dwellers in nairobi are sicker, are less likely to utilize health services when sick, and stand greater risk to die. our results suggest policies and programs contributing to the attainment of the millennium development goal on child health should pay particular attention to the urban poor. the insignificance of socioeconomic status suggests that poor health outcomes in these communities are compounded by poor environmental sanitation and behavioral factors that could partly be improved through female education and behavior change communication. introduction: historic trade city surat with its industrial and political peace has remained a center of attraction for people from all the comers of india resulting in to pop.ulatio~ explosio~ a~d stressed social and service infrastructure. the topography,dimate and demographic profile of the city s threat to the healthy environment. aim of this analysis is to review the impact of managemt'nt reform on health indicators. method: this paper is an analysis of the changing profile of population, sanitary infr~s~rucrure, local self government management and public health service reform, secondary health stat st cs data, health indicator and process monitoring of years. . . health of entire city and challenge to the management system. plague outbr~ak ( ) was the turning point in the history of civic service management including p~blic ~e~lth service management. ~ocal self government management system was revitalized by reg~lar_ field v s ts o~ al~ cadre~, _decentraltzanon of power and responsibility, equity, regular vigilant momtormg, commumcanon facility, ream_approach and people participation. reform in public health service management was throu_gh stan~~rd zed intervention protocol, innovative intervention, public private partnership, community part c panon, academic and service institute collaboration and research. sanitation service coverage have reached nearer to universal. area covered by safe water supply reached to %( ) from % ( ) and underground drainage to % ( ) from % ( ) the overhauling of the system have reflected on health indicators of vector and water born disease. malaria spr declined to . ( ) from . 'yo(! ) and diarrhea case report declined to ( ) from ( ). except dengue fever in no major disease outbreaks are reported after . city is recipient of international/national awards/ranking for these achievements. the health department have developed an evidence and experience based intervention and monitoring system and protocol for routine as well as disaster situation. the health service and management structure of surat city have emerged as an urban health model for the country. introduction: the center for healthy communities (chc) in the department of family and com· munity medicine at the medical college of wisconsin developed a pilot project to: ) assess the know· ledge, attitudes, and behaviors of female milwaukee public housing residents related to breast cancer; develop culturally and literacy appropriate education and screening modules; ) implement the developed modules; ) evaluate the modules; and ) provide follow-up services. using a community-based participatory research model the chc worked collaboratively with on-site nurse case management to meet these objectives. methods: a "breast health kick off event" was held at four separate milwaukee public housing sites for elderly and disabled adults. female residents were invited to complete a -item breast health survey, designed to accommodate various literacy levels. responses were anonymous and voluntary. the survey asked women about their previous physical exams for breast health, and then presented a series of state· ments about breast cancer to determine any existing myths. the final part gathered information about personal risk for breast cancer, the highest level of education completed, and whether the respondents h;td ever used hormone replacement therapy and/or consumed alcohol. responses were collected for descriptive analysis. results: a total of surveys (representing % of the total female population in the four sites) were completed and analyzed. % reported that they had a physical exam in the previous rwo years. % of respondents indicated they never had been diagnosed with breast cancer. % reported having had a mammogram and % having had a clinical breast exam. those that never had a mammogram reported a fear of what the provider would discover or there were not any current breast problems ro warrant an exam. % agreed that finding breast cancer early could lower the chance of dying of cancer. over % reported that mammograms were helpful in finding cancer. however, % believed that hav· ing a mammogram actually prevents breast cancer. % indicated that mammograms actually cause cancer and % reported that a woman should get a mammogram only if there is breast cancer in her family. conclusion: this survey indicates that current information about the importance of mammograms and clinical breast exams is reaching traditionally underserved women. yet there are still critical oppor· tunities to provide valuable education on breast health. this pilot study can serve as a tool for shaping future studies of health education messages for underserved populations. located in a yourh serv· ~ng agency m downtow~ ottawa, the clinic brings together community partners to provide primary medical care. and dent~i hygiene t? the street youths of ottawa aged - . the primary goal of the project is to provide accessible, coordinated, comprehensive health and dental care to vulnerable adolescents. these efforts respond to the pre-existing body of evidence suggesting that the principle barrier in accessing such care for these youths are feelings of intimidation and vulnerability in the face of a complex healthcare system. the bruyere fhn satellite clinic is located in the basement of a downtown drop-in and brings together a family medicine physician and her residents, a dental hygienist and her nd year students, a nurse practitioner, a chiropodist and public health nurses to provide primary care. the clinic has been extremely busy and well received by the youth. this workshop will demonstrate how five community organizations have come together to meet the needs of high risk youths in ottawa. this presentation will showcase the development of the clinic from its inception through its first year including reaction of the youths, partnerships and lessons learned. it will also focus on its sustainability without continued funding. we hope to have developed a model of service delivery that could be reproduced and sustained in other large cities with faculties of medicine. methods: non-randomized, mixed method design involving a process and impact evaluation. data collection-qualitative-a) semi structured interviews with providers & partners b)focus groups with youth quantitative a)electronic medical records for months records (budget, photos, project information). results: ) successfully built and opened a medicaudental clinic which will celebrate its year anniversary in august. ) over youths have been seen, and we have had over visits. conclusion: ) the clinic will continue to operate beyond the month project funding. ) the health of high risk youth in ottawa will continue to improve due to increased access to medical services. p - (a) health services -for the citizens of bangalore -past, present and future savita sathyagala, girish rao, thandavamurthy shetty, and subhash chandra bangalore city, the capital of karnataka with . million is the th most populous city in india; supporting % of the urban population of karnataka, it is considered as one of the fastest growing cities in india. known as the 'silicon valley of india', bangalore is nearly years old. bangalore city corporation (bmp), is a local self government and has the statutory commitment to provide to the citizens of bangalore: good roads, sanitation, street lighting, safe drinking water apart from other social obligations, cultural development and poverty alleviation activities. providing preventive and promotive heahh services is also a specific component. the objective of this study was to review the planning process with respect to health care services in the period since india independence; the specific research questions being what has been the strategies adopted by the city planners to address to the growing needs of the population amidst the background of the different strategies adopted by the country as a whole. three broad rime ranges have been considered for analysis: the s, s and the s. the salient results are: major area of focus has been on the maternal and child care with activities ranging from day-care to in-patient-care; though the number of institutions have grown from to the current day , their distribution has been far from satisfactory; obtaining support from the india population projects and major upgradarions have been undertaken in terms of infrastructure; over the years, in addition to the dispensaries of modern system of medicine, local traditional systems have also been initiated; the city has partnered with the healthy cities campaign with mixed success; disease surveillance, addressing the problems related to the emerging non-communicable diseases including mental health and road traffic injuries are still in its infancy. isolated attempts have been made to address the risks groups of elderly care and adolescent care. what stands out remarkably amongst the cities achievements is its ability to elicit participation from ngos, cbos and neighbourhood groups. however, the harnessing of this ability into the health sector cannot be said totally successful. the moot question in all the above observed development are: has the city rationally addressed it planning needs? the progress made so far can be considered as stuttered. the analysis and its presentation would identify the key posirive elements in the growth of banglore city and spell a framework for the new public health. introduction: anaemia associated with pregnancy is a major public health problem all over the world. different studies in different parts of india shown prevalence of anaemia between - %. anaemia remains a serious health problem in pregnancy despite of strong action taken by the government of india through national programmes. in the present study we identified th~ social beha~iors, responsible for low compliance of if a tablets consumption in pregnancy at community level and intervention was given with new modified behaviors on trial bases. . in vadodara urban. anganwadies out of were selected from the list by random sampling for tips (trials of improved practices) study. . . participants: pregnant women ( , intervention group+ , control. group) registered m the above anganwadies. study was conducted in to three phases: phase: . formative research and baseline survey (frbs). data was collected from all pregnant women to identify behaviors that are responsible for low compliance of ifa tablets. both qualitative and quantitative data were collected. haemoglobin was estimated of all pregnant women by haemo-cue. phase: . phase of tips. behaviors were identified both social & clinical for low compliance of ifa tablets consumption in pregnancy from frbs and against those, modified behaviors were proposed to pregnant women in the intervention group on trial bases by health education. trial period of weeks was given for trial of new behaviors to pregnant women in the interven· tion group. phase: . in this phase, feedbacks on behaviors tried or not tried were taken from pregnant women in intervention group. haemoglobin estimation was carried out again in all pregnant women. at the end of the study, messages were formulated on the bases of feedbacks from the pregnant women. results: all pregnant women in the intervention group had given positive feedback on new modified behaviors after intervention. mean haemoglobin concentration was higher in intervention group ( . ± . gm%) than control group ( . ± . gm%). ifa tablets compliance was improved in intervention group ( . %) than control group ( . %). conclusion: all pregnant women got benefits after trial of new modified behaviors in the intervention group. messages were formulated from the new modified behaviors, which can be used for longterm strategies for anaemia control in the community. introduction: in order to develop a comprehensive mch handbook for pregnant women and to assess its effect among them, a pilot study was carried out at the maternal and child health training institute (mchti), in dhaka, bangladesh. methods: from mchti a sample of pregnant women was selected and all subjects were women who were attending the first visit of their current pregnancy by using a random sampling method. of the subjects, women were given the mch handbook as case and women were not given the handbook as control. data on pre and post intervention of the handbook from the cases and controls were taken from data recording forms between the st of november and st of october, and data was analysed by using a multilevel analysis approach. this was a hospital-based action (case-control) research, and was applied in order to measure the outcome of pre and post intervention following the introduction of the handbook. data was used to assess the effects of utilisation of the handbook on women's knowledge, practice and utilisation of mch services. results: this study showed that the change of knowledge about antenatal care visits was . % among case mothers. knowledge of danger signs improved . %, breast feeding results . %, vaccination . % and family planning results improved . % among case. results showed some positive changes in women's attitudes among case mothers and study showed the change of practice in antenatal care visits was .u. % in the case. other notable changes were: change of practice in case mother's tetanus toxoid (ti), . %; and family planning . %. in addition, handbook assessment study indicated that most women brought the handbook on subsequent visits ( . %), the handbook was highly utilised (i.e. it was read by . %, filled-in by . %, and was used as a health education tool by . %). most women kept the handbook ( . %) and found it highly useful ( . %) with a high client satisfaction rate of . %. conclusion: pregnant women in the case group had higher knowledge, better practices, and higher utilisation of mch services than mothers in the control groups who used alternative health cards. if the handbook is developed with a focus on utilising a problem-oriented approach and involving the recomendations .of end~users, it is anticipated that the mch handbook will contribute significantly to ensuring the quahry of hfe of women and their children in bangladesh. after several meetmgs to identify the needs of the community, a faso clinic was opened at ncfs. health care professionals from smh joined with developmental and social service workers from ncfs to implement the faso diagnostic process and to provide culturally appropriate after-care. the clinic is unique in that its focus is the high risk urban aboriginal population of toronto. it accepts referrals of not only children and youth, but also of adults. lessons learned: response to the faso clinic at native child and family services has been overwhelming. aboriginal children with f asd are receiving timely diagnosis and interventions. aboriginal youth and adults who have been struggling with poveny, substance abuse, and homelessness are more willing to enter the ncfs centre for diagnosis and treatment. aboriginal infants prenatally exposed to alcohol born at st. michael's hospital or referred by other centres have access to the developmental programs located in both of the partnering agencies. the presentation will describe the clinic's development, and will detail the outcomes described, including interventions unique to the aboriginal culture. p - (c) seeds, soil, and stories: an exploration of community gardening in southeast toronto carolin taran, sarah wakefield, jennifer reynolds, and fiona yeudall introduction: community gardens are increasingly seen as a mechanism for improving nutrition and increasing food security in urban neighbourhoods, but the evidence available to support these claims is limited. in order to begin to address this gap in a way that is respectful of community knowledge and needs, the urban gardening research opportunities workgroup (ugrow) project explored the benefits and potential risks of community gardening in southeast toronto. the project used a community-based research (cbr) model to assess community gardens as a means of improving local health. the research process included interviews, focus groups, and participant observation (documented in field notes). we also directly engaged the community in the research process, through co-learning activities and community events which allowed participants to express their views and comment on emerging results. most of the research was conducted by a community-based research associate, herself a community gardener. key results were derived from these various sources through line-by-line coding of interview transcripts and field note review, an interactive and iterative process which involved both academic and community partners. results: these various data sources all suggest that enhanced health and access to fresh produce are important components of the gardening experience. they also highlight the central importance of empowering and community-building aspects of gardening to gardeners. community gardens were thought to play a role in developing friendships and social support, sharing food and other resources, appreciating cultural diversity, learning together, enhancing local place attachment and stewardship, and mobilizing to solve local problems (both inside and outside the garden). potential challenges to community gardens as a mechanism for communiry development include bureaucratic resistance to gardens, insecure land tenure and access, concerns about soil contamination, and a lack of awareness and under· standing by community members and decision-makers of all kinds. conclusion: the results highlight many health and broader social benefits experienced by commu· nity gardeners. they also point to the need for greater support for community gardening programs, par· ticularly ongoing the ongoing provision of resources and education programs to support gardens in their many roles. this research project is supported by the wellesley central health corporation and the centre for urban health initiatives, a cihr funded centre for research development hased at the univer· sity of toronto. p - (c) developing resiliency in children living in disadvantaged neighbourhoods sarah farrell, lorna weigand, and wayne hammond the traditional idea of targeting risk reduction by focusing on the development of eff~ctive coping strategies and educational programs has merit in light of the research reportmg_ that_ ~ lupl.e forms of problem behaviour consistently appear to be predicted by increasing exposure to den_uf able risk factors. as a result, many of the disadvantaged child and youth studies have focused on trymg to better _unde.r· stand the multiple risk factors that increase the likelihood of the development of at nsk behaviour m ch ldren/youth and the potential implications for prevention. this in turn has led t_o. the conclus on that community and health programs need to focus on risk reduction by helpm~ md v duals develop more effective coping strategies and a better understanding of the limitations of cenam pathologies, problematic v poster sessions coping behaviours and risk factors potentially inheren~ in high needs co~unities. ~owever, another ai:ea of research has proposed that preventative interventions should cons de~ .~rotecnve fa~ors alo~~ with reducing risk factors. as opposed to just emphasizing problems, vulnerab ht es, and deficits, a res liencybased perspective holds the belief that children, youth and their families. have strengths, reso~ce.s and the ability to cope with significant adversity in ways that are not only effective, but tend to result m mcreased ability to constructively respond to future adversity. with this in mind, a participatory research project sponsored by the united way of greater toronto was initiated to evaluate and determine the resiliency profiles of children - years (n = ) of recent immigrant families living in significantly disadvantaged communities in the toronto area. the presentation will provide an overview of the identified protective factors (both intrinsic and extrinsic) and resiliency profiles in an aggregated format as well as a summary of how the children and their parents interpreted and explained these strength-based results. as part of the focus groups, current community programs and services were examined by the participants as to what might be best practices for supporting the development and maintaining of resiliency in children, families and communities. it was proposed that the community model of assessing resiliency and protective factors as well as proposed best strength-based practice could serve as a guide for all in the community sector who provide services and programs to those in disadvantaged neighbourhoods. p - (c) naloxone by prescription in san francisco, ca and new york, ny emalie huriaux the harm reduction coalition's overdose project works to reduce the number of fatal overdoses to zero. located in new york, ny and san francisco, ca, the overdose project provides overdose education for social service providers, single-room occupancy hotel (sro) residents, and syringe exchange participants. the project also conducts an innovative naloxone prescription program, providing naloxone, an opiate antagonist traditionally administered by paramedics to temporarily reverse the effects of opiate overdose, to injection drug users (idus). we will describe how naloxone distribution became a reality in new york and san francisco, how the project works, and our results. the naloxone prescription program utilizes multiple models to reach idus, including sro-and street-based trainings, and office-based trainings at syringe exchange sites. trainings include information on overdose prevention, recognition, and response. a clinician conducts a medical intake with participants and provides them with pre-filled units of naloxone. in new york, funding was initially provided by tides foundation. new york city council provides current funding. new york department of mental health and hygiene provides program oversight. while the new york project was initiated in june , over half the trainings have been since march . in san francisco, california endowment, tides foundation, and san francisco department of public health (sfdph) provide funding. in addition, sfdph purchases naloxone and provides clinicians who conduct medical intakes with participants. trainings have been conducted since november . to date, nearly individuals have been trained and provided with naloxone. approximately of them have returned for refills and reported that they used naloxone to reverse an opiate-related overdose. limited episodes of adverse effects have been reported, including vomiting, seizure, and "loss of friendship." in new york, individuals have been trained and provided with naloxone. over overdose reversals have been reported. over half of the participants in new york have been trained in the south bronx, the area of new york with the highest rate of overdose fatalities. in san francisco, individuals have been trained and provided with naloxone. over overdose reversals have been reported. the majority of the participants in san francisco have been trained in the tenderloin, th street corridor, and mission, areas with the highest rates of overdose fatalities. the experience of the overdose project in both cities indicates that providing idus low-threshold access to naloxone and overdose information is a cost-effective, efficient, and safe intervention to prevent accidental death in this population. p - (c) successful strategies to regulate nuisance liquor stores using community mobilization, law enforcement, city council, merchants and researchers tahra goraya presenta~ion _will discuss ~uccessful environmental and public policy strategies employed in one southen: cahf?rmna commumty to remedy problems associated with nuisance liquor stores. participants ~ be given tools to understand the importance of utilizing various substance abuse prevention str~tegi~ to change local policies and the importance of involving various sectors in the community to a~_ st with and advocate for community-wide policy changes. recent policy successes from the commultles of pa~ad~na and altad~na will highlight the collaborative process by which the community mobilized resulnng m several ordmances, how local law enforcement was given more authority to monitor poster sessions v nonconforming liquor stores, how collaborative efforts with liquor store owners helped to remove high alcohol content alcohol products from their establishments and how a community-based organiz,uion worked with local legislators to introduce statewide legislation regarding the regulation of nuisance liquor outlets. p - (c) "dialogue on sex and life": a reliable health promotion tool among street-involved youth beth hayhoe and tracey methven introduction: street involved youth are a marginalized population that participate in extremely risky behaviours and have multiple health issues. unfortunately, because of previous abuses and negative experiences, they also have an extreme distrust of the adults who could help them. in , toronto public health granted funding to a non governmental, nor for profit drop-in centre for street youth aged - , to educate them about how to decrease rhe risk of acquiring hiv. since then the funding has been renewed yearly and the program has evolved as needed in order to target the maximum number of youth and provide them with vital information in a candid and enjoyable atmosphere. methods: using a retrospective analysis of the six years of data gathered from the "dialogue on sex and life" program, the researchers examined the number of youth involved, the kinds of things discussed, and the number of youth trained as peer leaders. also reviewed, was written feedback from the weekly logs, and anecdotal outcomes noted by the facilitators and other staff in the organization. results: over the five year period of this program, many of youth have participated in one hour sessions of candid discussion regarding a wide range of topics including sexual health, drug use, harm reduction, relationship issues, parenting, street culture, safety and life skills. many were new youth who had not participated in the program before and were often new to the street. some of the youth were given specific training regarding facilitation skills, sexual anatomy and physiology, birth control, sexually transmitted infections, hiv, substance use/abuse, harm reduction, relationships and discussion of their next steps/future plans following completion of the training. feedback has been overwhelmingly positive and stories of life changing decisions have been reported. conclusion: clearly, this program is a successful tool to reach street involved youth who may otherwise be wary of adults and their beliefs. based on data from the evaluation, recommendations have been made to public health to expand the funding and the training for peer leaders in order ro target between - new youth per year, increase the total numbers of youth reached and to increase the level of knowledge among the peer leaders. p - (c) access to identification and services jane kali replacing identification has become increasingly more complex as rhe government identification issuing offices introduce new requirements rhar create significant barriers for homeless people to replace their id. new forms of identification have also been introduced that art' not accessible to homekss peoplt-(e.g. the permanent resident card). ar rhe same time, many service providers continue to require identifi· cation ro access supports such as income, housing, food, health care, employment and employmt·nt training programs. street health, as well as a number of other agencies and community health centres, h, , been assisting with identification replacement for homeless peoplt· for a number of years. the rnrrt·nr challenges inherent within new replacement requirements, as well as the introduction of new forn ' of identification, have resulted in further barriers homeless people encounter when rrring to access t:ssential services. street health has been highlighting these issues to government identification issuing offices, as well as policy makers, in an effort to ensure rhar people who are homeless and marginalized have ac'ess to needed essential services. bandar is a somali word for •·a safe place." the bandar research project is the product of the regent park community health centre. the research looks ar the increasing number of somali and afri· can men in the homeless and precariously house population in the inner city core of down~own toronto. in the first phase of the pilot project, a needs assessment was conducted to dennfy barners and issues faced by rhe somali and other african men who are homeless and have add cr ns issues. th_e second phase of rhe research project was to identify long rerm resources and service delivery mechamsms that v poster sessions would enhance the abiity of this population to better access detox, treatment, and post treatment ser· vices. the final phase of the project was to facilitate the development of a conceptual model of seamless continual services and supports from the streets to detox to treatment to long term rehabilitation to housing. "between the pestle and mortar" -safe place. p - (c) successful methods for studying transient populations while improving public health beth hayhoe, ruth ewert, eileen mcmahon, and dan jang introduction: street youth are a group that do not regularly access healthcare because of their mis· trust of adults. when they do access health care, it is usually for issues severe enough for hospitalization or for episodic care in community clinics. health promotion and illness prevention is rarely a part of their thinking. thus, standard public health measures implemented in a more stable population do not work in this group. for example, pap tests, which have dearly been shown to decrease prevalence of cer· vical cancer, are rarely done and when they are, rarely followed up. methods to meet the health care needs and increase the health of this population are frequently being sought. methods: a drop-in centre for street youth in canada has participated in several studies investigating sexual health in both men and women. we required the sponsoring agencies to pay the youth for their rime, even though the testing they were undergoing was necessary according to public health stan· dards. we surmised that this would increase both initial participation and return. results: many results requiring intervention have been detected. given the transient nature of this population, return rates have been encouraging so far. conclusion: it seems evident that even a small incentive for this population increases participation in needed health examinations and studies. it is possible that matching the initial and follow-up incentives would increase the return rate even further. the fact that the youth were recruited on site, and not from any external advertising, indicates that studies done where youth trust the staff, are more likely to be successful. the presentation will share the results of the "empowering stroke prevention project" which incor· porated self-help mutual aids strategies as a health promotion methodology. the presentation will include project's theoretical basis, methodology, outcomes and evaluation results. self-help methodology has proven successful in consumer involvement and behaviour modification in "at risk," "marginalized" settings. self-help is a process of learning with and from each other which provides participants oppor· tunities for support in dealing with a problem, issue, condition or need. self-help groups are mechanisms for the participants to investigate existing solutions and discover alternatives, empowering themselves in this process. learning dynamic in self-help groups is similar to that of cooperative learning and peertraining, has proven successful, effective and efficient (haller et al, ) . the mutual support provided by participation in these groups is documented as contributory factor in the improved health of those involved. cognizant of the above theoretical basis, in the self-help resource centre initiated the "empowering stroke prevention project." the project was implemented after the input from health organizations, a scan of more than resources and an in-depth analysis of risk-factor-specific stroke prevention materials indicated the need for such a program. the project objectives were:• to develop a holistic and empowering health promotion model for stroke prevention that incorporates selfhelp and peer support strategies. • to develop educational materials that place modifiable risk factors and lifestyle information in a relevant context that validates project participants' life experiences and perspectives.• to educate members of at-risk communities about the modifiable risk factors associated with stroke, and promote healthy living. to achieve the above, a diverse group of community members were engaged as "co-editors" in the development of stroke prevention education materials which reflected and validated their life experiences. these community members received training to become lay health promoters (trained volunteer peer facilitators). in collaboration with local health organizations, these trained lay health promoters were then supported in organizing their own community-based stroke prevention activities. in addition, an educational booklet written in plain language, entitled healthy ways to prevent stroke: a guide for you, and a companion guide called healthy ways to pre· vent stroke: a facilitator's guide were produced. the presentation will include the results of a tw<>tiered evaluation of the program methodology, educational materials and the use of the materials beyond the life of the project. this poster presentation will focus on the development and structure of an innovative street outreach service that assists individuals who struggle mental illness/addictions and are experiencing homelessness. the mental health/outreach team at public health and community services (phcs) of hamilton, ontario assists individuals in reconnecting with health and social services. each worker brings to the ream his or her own skills-set, rendering it extremely effective at addressing the multidimensional and complex needs of clients. using a capacity building framework, each ream member is employed under a service contract between public health and community services and a local grassroots agency. there are public health nurses (phn), two of whom run a street health centre and one of canada's oldest and most successful needle exchange programs, mental health workers, housing specialists, a harm reduction worker, youth workers, and a united church minister, to name a few. a community advisory board, composed of consumers and professionals, advises the program quarterly. the program is featured on raising the roors 'shared learnings on homelessness' website at www.sharedlearnings.ca. through our poster presentation participants will learn how to create effective partnerships between government and grassroots agencies using a capacity building model that builds on existing programs. this study aims to assess the effects of broadcasting a series of documentary and drama videos, intended to provide information about the bc healthguide program in farsi, on the awareness about and the patterns of the service usage among farsi-speaking communities in the greater vancouver area. the major goals of the present study were twofold; ( ) to compare two methods of communications (direct vs. indirect messages) on the attitudes and perceptions of the viewers regarding the credibility of messengers and the relevance of the information provided in the videos, and ( ) to compare and contrast the impact of providing health information (i.e., the produced videos) via local tvs with the same materials when presented in group sessions (using vcr) on participants' attitudes and perceptions cowards the bc healrhguide services. results: through a telephone survey, farsi-speaking adults were interviewed in november and december . the preliminary findings show that % of the participants had seen the aired videos, from which, % watched at least one of the 'drama' clips, % watched only 'documentary' clip, and % watched both types of video. in addition, % of the respondents claimed that they were aware about the program before watching the aired videos, while % said they leaned about the services only after watching the videos. from this group, % said they called the bchg for their own or their "hildren's health problems in the past month. % also indicated that they would use the services in the future whenever it would be needed. % considered the videos as "very good" and thought they rnuld deliver relevant messages and % expressed their wish to increase the variety of subjects (produ\:e more videos) and increase the frequency of video dips. conclusion: the results of this study will assist public health specialists in bc who want to choose the best medium for disseminating information and apply communication interventions in multi\:ultural communities. introduction: many theorists and practitioners in community-based research (cbr) and knowledge transfer (kt) strongly advocate for involvement of potential users of research in the development of research projects, yet few examples of such involvement exist for urban workplace health interventions. we describe the process of developing a collaborative research program. methods: four different sets of stakeholders were identified as potential contributors to and users of the research: workplace health policy makers, employers, trade unions, and health and safety associations. representatives of these stakeholders formed an advisory committee which met quarterly. over the month research development period, an additional meetings were held between resc:ar~h~rs and stakeholders. in keeping with participant observation approaches, field notes of group and md v ~ ual meetings were kept by the two co-authors. emails and telephone calls were also documented. qu~h tative approaches to textual analysis were used, with particular attention paid to collaborattve v poster sessions relationships established (as per cbr), indicators of stakeholders' knowledge utilization (as per kt), and transformations of the proposed research (as per cbr). results: despite initial strong differences of opinion both among stakeho~ders .an~ between stakeholders and researchers, goodwill was noted among all involved. acts of rec~proc ty included mu.rual sharing of assessment tools, guidance on data utilization to stakeho~der orga~ zat ns, and suggestions on workplace recruitment to researchers. stakeholders demonstrated mcreases m concep~ual. un~erstand ing of workplace health e.g. they more commonly discussed more complex,. psychosocial md cators of organizational health. stakeholders made instrumental use of shared materials based on research e.g. adapting their consulting model to more sophisticated dat~ analysis. sta~ehol?~rs recogni_zed the strategic use of their alliance with researchers e.g., transformational leadership trainmg as a~ inducement to improve health and safety among small service franchises. stakeholders helped re-define the research questions, dramatically changed the method of recruitment from researcher cold call to stakeholderbased recruitment, and strongly influenced pilot research designs. owing a great deal to the elaborate joint development process, the four collaboratively developed pilot project submissions which were all successfully funded. conclusion: the intensive process of collaborative development of a research program among stakeholders and researchers was not a smooth process and was time consuming. nevertheless, the result of the collaborative process was a set of projects that were more responsive to stakeholder needs, more feasible for implementation, and more broadly applicable to relevant workplace health problems. introduction: environmental groups, municipal public health authorities and, increasingly, the general public are advocating for reductions in pesticide use in urban areas, primarily because of concern around potential adverse health impacts in vulnerable populations. however, limited evidence of the relative merits of different intervention strategies in different contexts exists. in a pilot research project, we sought to explore the options for evaluating pesticide reduction interventions across ontario municipalities. methods: the project team and a multi-stakeholder project advisory committee (pac), generated a list of potential key informants (kl) and an open ended interview guide. thirteen ki from municipal government, industry, health care, and environmental organizations completed face to face or telephone interviews lasting - minutes. in a parallel process, a workshop involving similar representatives and health researchers was held to discuss the role of pesticide exposure monitoring. minutes from pac meetings, field notes taken during ki interviews, and workshop proceedings were synthesized to generate potential evaluation methods and indicators. results: current evaluation activities were limited but all kls supported greater evaluation effons beginning with fuller indicator monitoring. indicators of education and outreach services were imponant for industry representatives changing applicator practices as well as most public health units and environmental organizations. lndictors based on bylaw enforcement were only applicable in the two cities with bylaws, though changing attitudes toward legal approaches were being assessed in many communities. the public health rapid risk factor surveillance system could use historical baseline data to assess changes in community behaviour through reported pesticide uses and practices, though it had limited penetration in immigrant communities not comfortable in english. pesticide sales (economic) data were only available in regional aggregates not useful for city specific change documentation. testing for watercourse or environmental contamination might be helpful, but it is sporadic and expensive. human exposure monitoring was fraught with ethical issues, floor effects from low levels of exposure, and prohibitive costs. clinical episodes of pesticide exposure reported to the regional poison centre (all ages) or the mother risk program (pregnant or breastfeeding women) are likely substantial underestimates that would be need to be supplemented with sentinel practice surveillance. focus on special clinical populations e.g., multiple chemical sensitivity would require additional data collection efforts . . conc~ons: broad support for evaluation and multiple indicators were proposed, though con-s~raints associate~ with access, coverage, sensitivity and feasibility were all raised, demonstrating the difficulty of evaluating such urban primary prevention initiatives. interventionists. an important aim of the youth monitor is to learn more about the health development of children and adolescents and the factors that can influence this development. special attention is paid to emo· tional and behavioural problems. the youth monitor identifies high-risk groups and factors that are associated with health problems. at various stages, the youth monitor chancrs the course of life of a child. the sources of informa· tion and methods of research are different for each age group. the results arc used to generate various kinds of repons: for children and young persons, parents, schools, neighbourhoods, boroughs and the municipality of rotterdam and its environs. any problems can be spotted early, at borough and neigh· bourhood level, based on the type of school or among the young persons and children themselves. together with schools, parents, youngsters and various organisations in the area, the municipal health service aims to really address these problems. on request, an overview is offered of potentially suitable interventions. the authors will present the philosophy, working method, preliminary effects and future developments of this instrument, which serves as the backbone for the rotterdam local youth policy. social workers to be leaders in response to aging urban populations: the practicum partnership program sarah sisco, alissa yarkony, and patricia volland "'" tliu:tion: across the us, . % of those over live in urban areas. these aging urban popu· lations, including the baby boomers, have already begun encounter a range of heahh and mental hcahh conditions. to compound these effects, health and social service delivery fluciuates in cities, whit:h arc increasingly diverse both in their recipients and their systems. common to other disciplines (medicine, nursing, psychology, etc.) the social work profession faces a shortage of workers who are well-equipped to navigate the many systems, services, and requisite care that this vast population requires. in the next two decades, it is projected that nearly , social workers will be required to provide suppon to our older urban populations. social workers must be prepared to be aging-savvy leaders in their field, whether they specialize in gerontology or work across the life span. mllhotu: in , a study conducted at the new york academy of medicine d<> :umcntcd the need for improved synchroniciry in two aspects of social work education, classroom instruction and the field experience. with suppon from the john a. hanford foundation, our team created a pilot proj~"t entitled the practicum pannership program (ppp) in master's level schools of social work, to improvt" aginr exposure in field and classroom content through use of the following: i) community-university partnrr· ships, ) increased, diverse student field rotations, ll infusion of competcn ."}'·drivm coursework, enhancement of field instructors' roles, and ) concentrated student recruitment. we conductt"d a prr· and post-test survey into students' knowledge, skills. and satisfaction. icarlja: surveys of over graduates and field inltnk."tors rcflected increased numlk-n of . rrm:y· univmity panncrships, as well as in students placed in aging agencin for field placements. there wa marked increase in student commitments to an aging specialization. onr year por.t·gradu:nion rcvealrd that % of those surveyed were gainfully employed, with % employed in the field of aginic. by com· bining curricular enhancement with real-world experiences the ppp instilled a broad exposurr for llu· dents who worked with aging populations in multiple urban settings. coltdtuion: increased exposure to a range of levels of practicr, including clinical, policy/ajvocaq, and community-based can potentially improve service delivery for older adulh who live in elfin, and potentially improve national policy. the hanford foundation has now elected to uppon cxpantion of the ppp to schools nationwide (urban and rural) to complement other domntic initiatives to cnhalk"c" holistic services for older adults across the aging spectrum. bodrgnn.ntl: we arc a team of rcscarcbcn and community panncn working tcj c(her to develop an in"itepth understanding of the mental health needs of homeless youth ~ages to ) (using qualiutivc and quantitative methods ' panicipatory rncarch methods). it is readily apparmt that '-neless youth cxpcricnce a range of mental health problems. for youth living on the street, menul illnew may be either a major risk factor for homelessnal or may frequently emcsge in response to coping with rhe multitudinous stressors associated with homclcslllcsi including exposure to violence, prasutt to pamaplte in v poster sessions survival sex and/or drug use. the most frequent psychiatric diagnoses amongst the homeless gencrally include: depression, anxiety and psychosis. . . . the ultimate ob ective of the pr~am of rei:e~ is to ~evelop a plan for intervention to meet the mental health needs of street youth. prior t_o pl~nnmg mtervenbons, .it is necessary to undertake a comprehensive assessment ~f mental health needs m this ~lnerable populanon. thus, the immediate objective of this research study is to undertake a comprehensive assessment of men· tal health needs. . . melbotlology: a mixed methodology triangulating qualitative, participatory acnon and quantitative methods will capture the data related to mental health needs of homeless youth. a purposive sample of approximately - subjecrs. ages to , is currently being ~ted ~participate from the commu.nity agencies covenant house, evergreen centre fo~ srrc;et youth, turning p? ?t and street ~ serv~. youth living on the street or in short -term residennal programs for a mmimum of month pnor to their participation; ages to and able to give infonned consent will be invited to participate in the study. o..tcomes: the expected outcome of this initial survey will be an increased understanding of mental health needs of street youth that will be used to develop effective interventions. it is anticipated that results from this study will contribute to the development of mental health policy, as well as future programs that are relevant to the mental health needs of street youth. note: it is anticipated that preliminary quantitative data ( subjects) and qualitative data will be available for the conference. the authors intend to present the identification of the research focus, the formation of our community-based team, relevance for policy, as well as preliminary results. p - (a) the need for developing a firm health policy for urban informal worken: the case of despite their critical role in producing food for urban in kenya, urban farmers have largely been ignored by government planners and policymakers. their activity is at best dismissed as peripheral eveo, inappropriate retention of peasant culture in cities and at worst illegal and often some-times criminal· ized. urban agriculture is also condemned for its presumed negative health impact. a myth that contin· ues despite proof to the contrary is that malarial mosquitoes breed in maize grown in east african towns. however, potential health risks are insignificant compared with the benefits of urban food production. recent studies too rightly do point to the commercial value of food produced in the urban area while underscoring the importance of urban farming as a survival strategy among the urban poor, especially women-headed households. since the millennium declaration, health has emerged as one of the most serious casualties consequent on the poverty, social exclusion, marginalisation and lack of sustain· able development in africa. hiv/aids epidemic poses an unprecedented challenge, while malaria, tuber· culosis, communicable diseases of childhood all add to the untenable burden. malnutrition underpins much ill-health and is linked to more than per cent of all childhood deaths. kenya's urban poor people ~ace ~ h~ge burde~ of preventable and treatable health problems, measured by any social and bi~ medical md cator, which not only cause unnecessary death and suffering, but also undermine econonuc development and damage the country's social fabric. the burden is in spite of the availability of suitable tools and re:c=hnology for prevention and treatment and is largely rooted in poverty and in weak healah •rstems. this pa~ therefore challenges development planners who perceive a dichotomy instead of con· tmuum between informal and formal urban wage earners in so far as access to health services is con· cemed. it i~ this gap that calls for a need to developing and building sustainable health systems among the urban mformal ~wellers. we recommend a focus on an urban health policy that can build and strengthen the capacity of urban dwellers to access health services that is cost-effective and sustainable. such ~ health poli<=>: must strive for equity for the urban poor, displaced or marginalized; mobilise and effect ~ely use sufficient sustainable resources in order to build secure health systems and services. special anenti_on. should ~ afforded hiv/aids in view of the unprecedented challenge that this epidemic poses to africa s economic and social development and to health services on the continent. methods: a review of the literature led us to construct three simple models and a composite model of exposure to traffic. the data were collected with the help of a daily diary of travel activities using a sample of cyclists who went to or come back from work or study. to calculate the distance, the length of journey, and the number of intersections crossed by a cyclist different geographic information systems (gis) were operated. statistical analysis was used to determine the significance between a measure of exposure on the one hand, and the sociodemographic characteristics of the panicipants or their geographic location on the other hand. restlltj: our results indicate that cyclists were significantly exposed to road accidents, no matter of where they live or what are their sociodemographic characteristics. we also stress the point that the fact of having been involved in a road accident was significantly related to the helmet use, but did not reduce the propensity of the cyclists to expose themselves to the road hazards. condlllion: the efforts of the various authorities as regards road safety should not be directed towards the reduction of the exposure of the vulnerable users, but rather towards the reduction of the dangers to which they could face. keywords: cyclist, daily diary of activities, measures of exposure to traffic, island of montreal. p - (a) intra urban disparities and environmental health: some salient features of nigerian residential neighbourhoods olumuyiwa akinbamijo intra urban disparities and environmental health: some salient features of nigerian residential neighbourhoods abstract urbanization panicularly in nigerian cities, ponends unprecedented crises of grave dimensions. from physical and demographic viewpoints, city growth rates are staggering coupled with gross inabilities to cope with the consequences. environmental and social ills associated with unguarded rapid urbanization characterize nigerian cities and threaten urban existence. this paper repons the findings of a recent study of the relationship between environmental health across inrraurban residential communities of akure, south west nigeria. it discuses the typical urbanization process of nigerian cities and its dynamic spatial-temporal characteristics. physical and socio-demographic attributes as well as the levels and effectiveness of urban infrastructural services are examined across the core residential districts and the elite residential layouts in the town. the incidence rate of cenain environmentally induced tropical diseases across residential neighborhoods and communes is examined. salient environmental variables that are germane to health procurement in the residential districts, incidence of diseases and diseases parasitology, diseases prevention and control were studied. field data were subjected to analysis ranging from the univariate and bivariate analysis. inferential statistics using the chi-square test were done to establish the truthfulness of the guiding hypothesis. given the above, the study affirms that there is strong independence in the studied communities, between the environment and incidence of diseases hence health of residents of the town. this assertion, tested statistically at the district levels revealed that residents of the core districts have very strong independence between the environment and incidences of diseases. the strength of this relationship however thins out towards the city peripheral districts. the study therefore concludes that since most of the city dwellers live in urban deprivation, urban health sensitive policies must be evolved. this is to cater for the urban dwellers who occupy fringe peripheral sites where the extension of facilities often times are illegally done. urban infrastructural facilities and services need be provided as a matter of public good for which there is no exclusive consumption or access even for the poorest of the urban poor. many suffer from low-self esteem, shame and guilt about their drug use. in addition, they often lack suppon or encounter opposition from their panners, family and friends in seeking treatment. these personal barriers are compounded by fragmented addiction, prenatal and social care services, inflexible intake systems and poor communication among sectors. the experience of accessing adequate care between services can be overwhelming and too demanding. the toronto centre for substance use in pregnancy (t-cup) is a unique program developed to minimize barriers by providing kone-stop" comprehensive healthcare. t-cup is a primary care based program located in the department of family medicine at st. joseph\'s health centre, a community teaching hospital in toronto. the interdisciplinary staff provides prenatal and addiction services, case management, as well as care of newborns affected by substance use. regular care plan meetings are held between t-cup, labour and delivery nurses and social workers in the y poster sessions maternity and child care program. t-cup also connects "'.omen with. inpatient treatment programs and community agencies such as breaking the cycle, an on-site counselmg group for pregnant substance users. · f · d d h ith method: retrospective chart review, qualitative patient ~ans action stu ~· an ea care provider surveys are used to determine outcomes. primary outcomes mclude changes m maternal su~tance use, psychosocial status and obstetrical complications (e.g. pre-rupture of membrane, pre-eclampsia, placen· ral abruption and hemorrhage). neonatal measures ~~nsisted of .bir~h pa_rame~ers, length of h~spital st.ay and complications (e.g. feral distress, meconium stammg, resuscitation, aund ce, hypoglycemia, seventy of withdrawal and treatment length). chart review consisted of all t-cup patients who met clinical cri· reria for alcohol or drug dependence and received prenatal and intra-partum care at st. joseph's from october to june . participants in the qualitative study included former and current t-cup patients. provider surveys were distributed on-site and to a local community hospital. raulb: preliminary evaluation has demonstrated positive results. treatment retention and satisfaction rates were high, maternal substance use was markedly reduced and neonatal outcomes have shown to be above those reported in literature. conclusion: this comprehensive, primary care model has shown to be optimal in the management of substance use in pregnancy and for improving neonatal outcomes. future research will focus on how this inexpensive program can be replicated in other health care settings. t-cup may prove to be the optimal model for providing care to pregnant substance users in canada. lntrod ction: cigarette smoking is one of the most serious health problems in taiwan. the prevalence of smoking in is . % in males . % in females aged years and older. although the government of taiwan passed a tobacco hazards control act in , it has not been strongly enforced in many places. therefore, community residents have often reported exposure of second hand smoke. the purpose of the study was to establish a device to build up more smoke-free environments in the city of tainan. methods: unique from traditional intervention studies, the study used a healthy city approach to help build up smoke-free environments. the major concept of the approach is to build up a healthy city platform, including organizing a steering committee, setting up policies and indicators, creating intersectoral collaboration, and increasing community participation. first, more than enthusiastic researchers, experts, governmental officers, city counselors and community leaders in tainan were invited in the healthy city committee. second, smoke-free policies, indicators for smoke-free environments, and mechanisms for inter-departmen· tal inspections were set up. third, community volunteers were recruited and trained for persuading related stakeholders. lastly, both penalties and rewards were used for help build up the environments. raults: aher two-year ( aher two-year ( - execution of the project, the results qualitatively showed that smoke-free environments in tainan were widely accepted and established, including smoke-free schools, smoke-free workpla~es, smoke-free households, smoke-free internet shops, and smoke-free restaurants. smoke~s were. effectively educated not to smoke in public places. community residents including adults and children m the smoke-free communities clearly understand the adverse effects of environmental tobacco smoke and actively participated anti-smoking activities. conclruions: healthy city platform is effective to conquer the barrier of limited anti-smoking rc:sources. nor. only can it enlar:ge community actions for anti-smoking campaigns, but also it can provide par_merships for collaboratjon. by establishing related policies and indicators the effects of smoke· free environments can be susta ·ned a d th · · · ' · n e progression can be monitored m a commuruty. these issues are used ~· oi::c it~ goals, weuha identifies issues that put people's health at risk. presently, team com~u:c: ran ee~tion !earns. (iats) that design integrative solutions ~tesj'°~ g om six to fifteen members. methods in order to establish wo-poster sessions v projects for weuha, the following approach was undertaken: i. a project-polling template was created and sent to all members of the alliance for their input. each member was asked to identify thdr top two population groups, and to suggest a project on which to focus over a - month period for each identified population. . there was a % response to the poll and the top three population groups were identified. data from the toronto community health profile database were utilized to contextualize the information supplied for these populations. a presentation was made to the steering committee and three population-based projects were selected, leaders identified and iats formed. three population-based projects: the population-based projects and health care issues identified are: newcomer prenatal uninsured women; this project will address the challenges faced by providers to a growing number of non-insured prenatal women seeking care. a service model where the barrier of "catchments" is removed to allow enhanced access and improved and co-ordinated service delivery will be pilot-tested. children/obesity/diab etes: using a health promotion model this team will focus on screening, intervention, and promoting healthy lifestyles (physical activity and nutrition) for families as well as for overweight and obese children. seniors health promotion and circle of discharge: this team will develop an early intervention model to assist seniors/family unit/caregivers in accessing information and receiving treatment/care in the community. the circle of discharge initiative will address ways of utilizing community supports to keep seniors in the community and minimize readmissions to acute care facilities. results/expected outcomes: coordinated and enhanced service delivery to identified populations, leading to improved access, improved quality of life, and health care for these targeted populations. introduction: basic human rights are often denied to high-risk populations and people living with hiv/aids. their rights to work and social security, health, privacy, non discrimination, liberty and freedom of movement, marriage and having a family have been compromised due to their sero-positive status and risk of being positive. the spread of hiv/aids has been accelerating due to the lack of general human rights among vulnerable groups. to formulate and implement effective responses needs dialogue and to prevent the epidemic to go underground barriers like stigma need to be overcome. objective: how to reduce the situation of stigma, discrimination and human rights violations experienced by people living with hiv/aids and those who are vulnerable to hiv/aids. methodology and findings: consultation meetings were strm.-rured around presentations, field visits, community meetings and group work to formulate recommendations on how govt and ngos/cbos should move forward based on objective. pakistan being a low prevalence country, the whole sense of compl;u:enc.:y that individuals are not subject to situations of vulnerable to hiv is the major threat to an explosion in th•· epidemic, therefore urgent measures are needed to integrate human rights issues from the very start of the response. the protection and promotion of human rights in an integral component of ;tll responses to the hiv/aids epidemic. it has been recognized that the response to hiv/aios must he multi sectoral and multi faceted, with each group contributing its particular expertise. for this to occur along with other knowlcdg<" more information is required in human rights abuses related to hiv/ aids in a particular scenario. the ~·on sultarion meetings on hiv/aids and human rights were an exemplary effort to achieve the same ohj<..:tivc. recommendations: the need for a comprehensive, integrated and a multi-sectoral appro;u.:h in addressing the issue of hiv/aids was highlighted. the need social, cultural and religious asp•·ct' to he: prominently addressed were identified. it was thought imperative measures even in low prevalence countries. education has a key role to play, there is a need for a code of ethics for media people and h<"alth care providers and violations should be closely monitored and follow up action taken. p - (c) how can community-based funding programs contribute to building community capacity and how can we measure this elusive goal? mary frances maclellan-wright, brenda cantin, mary jane buchanan, and tammy simpson community capacity building is recognized by the public health agency of canada (phac) as an important strategy for improving the overall health of communities by enabling communities to addre~s priority issues such as social and economic determinants of health. in / phac.:, alberta/nwf region's population health fund (phf) supported community-based projects to build community capacity on or across the determinants of health. specifically, this included creating accessible and sup· portive social and physical environments as well as creating tools and processes necessary for healthy policy development and implementation. the objective of this presentation is to highlight how the community capacity building tool, developed by phac ab/nwf region, can demonstrate gains in v poster sessions · · the course of a pror· ect and be used as a reflective tool for project planning and community capacity over . . . . i · a art of their reporting requirements, pro ect sites completed the community caparny eva uanon. s p . . th t i ii i'd d . building tool at the beginning and end of their ~ne-year prorect. e oo ~o ects va an reliable data in the context of community-based health prorects. developed through a vigorous ~nd collabora ve research process, the tool uses plain languag~ to expl~re nine key f~atures o~ commuruty cap~city with 't ch with a section for contextual information, of which also mdude a four-pomt raong ems, ea f fu d · scale. results show an increase in community capacity over the course o the nde prorects. pre and post aggregate data from the one-year projects measure~ statistic.ally si~n~ficant changes for of the scaled items. projects identified key areas of commumty capacity bmldmg that needed strengthemng, such as increasing participation, particularly among people with low incomes; engaging community members in identifying root causes; and linking with community groups. in completing the tool, projects examined root causes of the social and economic determinants of health, thereby exploring social justice issues related to the health of their community. results of the tool also served as a reflec· cion on the process of community capacity building; that is, how the project outcomes were achieved. projects also reported that the tool helped identify gaps and future directions, and was useful as a project planning, needs assessment and evaluation tool. community capacity building is a strategy that can be measured. the community capacity building tool provides a practical means to demonstrate gains in community capacity building. strengthening the elements of community capacity building through community-based funding can serve as building blocks for addressing other community issues. needs of marginalized crack users lorraine barnaby, victoria okazawa, barb panter, alan simpson, and bo yee thom background: the safer crack use coalition of toronto (scuc) was formed in in response to the growing concern for the health and well-being of marginalized crack users. a central concern was the alarm· ing hepatitis c rate ( %) amongst crack smokers and the lack of connection to prevention and health ser· vices. scuc is an innovative grassroots coalition comprised of front-line workers, crack users, researcher! and advocates. despite opposition and without funding, scuc has grown into the largest crack specific harm reduction coalition in canada and developed a nationally recognized sarer crack kit distribution program (involving community-based agencies that provide outreach to users). the success of our coalition derives from our dedication to the issue and from the involvement of those directly affected by crack use. setting: scuc's primary service region is greater toronto, a diverse, large urban centre. much ofour work is done in areas where homeless people, sex trade workers and drug users tend to congregate. recently, scuc has reached out to regional and national stakeholders to provide leadership and education. mandate: our mandate is to advocate for marginalized crack users and support the devdopmentof a com.p.rehensive harm reduction model that addresses the health and social needs facing crack users; and to fac htare the exchange of information between crack users, service providers, researchers, and policy developers across canada. owrview: the proposed workshop will provide participants with an overview of the devdopment of scuc, our current projects (including research, education, direct intervention and consultation), our challenge~ and s~ccesses and the role of community development and advocacy within the coalition. pre-senter~ will consist of community members who have personal crack use experience and front-line work· ers-, sc.uc conducted a community-based research project (toronto crack users perspectives, ) , in w~ich s focus groups with marginalized crack users across toronto were conducted. participants iden· t f ed health and social issues affecti h b · · · d " red . . ng t em, arrsers to needed services, personal strategies, an oue recommendations for improved services. presenters will share the methodology, results and recommen· datmns resulting from the research project. conc/usio": research, field observations and consultations with stakeholders have shown that cradck shmoke~s are at an. increased risk for sexually transmitted infections hiv/aids hepatitis c, tb an ot er serious health issues health · ff, · ' ' · · . · issues a ectmg crack users are due to high risk behavmurs, socio· economic factors, such as homeless d. · · · · d · . . ness, scrsmmat on, unemployment, violence incarceraoons, an soc a so at on, and a lack of comprehe · h i h · ' ns ve ea t and social services targeting crack users. · · sinct · s, owever arge remains a gross underesurnaoon. poster sessions v these are hospital-based reports and many known cases go unreported. however teh case, young age at first intercourse, inconsistent condom use and multiple partnersplace adolescents at high risks for a diverse array of stls, including hiv. about % of female nigerian secondary school students report initiating sexual intercourse before age years. % of nigerian female secondary school students report not using a condom the last time they had sexual intercourse. more than % of urban nigerian teens report inconsistent condom use. methods: adolescents were studied, ages to , from benin city in edo state. the models used were mother-daughter( ), mother -son( ), father -son ( ), and father-daughter( ). the effect of parent-child sexual communicationat baseline on child\'s report of sexual behavior, to months later were studied. greater amounts of sexual risk communication were asociated with markedly fewer episodes of unprotected sexual intercourse, reduced number of sexual partners and fewer episodes of unprotected sexual intercourse. results: this study proved that parents can exert more influence on the sexual knowledge attitudes and practise of their adolescent children through desired practises or rolemodeling, reiterating their values and appropriate monitoring of the adolescents\' behavior. they also stand to provide information about sexuality and various sexual topics. parental-child sexual communication has been found to be particularly influential and has been associated with later onset of sexual initiation among adolescents, less sexual activity, more responsible sexual attitudes including greater condom use, self efficacy and lower self -reported incidence of stis. conclusions: parents need to be trained to relate more effectively with their children/wards about issues related to sex and sexuality. family -based programs to reduce sexual risk-taking need to be developed. there is also the need to carry out cross-ethnicaland cross-cultural studies to identify how parent-child influences on adolescent sexual risk behavior may vary in different regions or countries, especially inthis era of the hiv pandemic. introduction: public health interventions to identify and eliminate health disparities require evidence-based policy and adequate model specification, which includes individuals within a socioecological context, and requires the integration of biosociomedical information. multiple public and private data sources need to be linked to apportion variation in health disparities ro individual risk factors, the health delivery system, and the geosocial environment. multilevel mapping of health disparities furthers the development of evidence-based interventions through the growth of the public health information network (phin-cdc) by linking clinical and population health data. clinical encounter data, administrative hospital data, population socioenvironmental data, and local health policy were examined in a three-level geocoded multilevel model to establish a tracking system for health disparities. nj has a long established political tradition of "home rule" based in elected municipal governments, which are responsible for the well-being of their populations. municipalities are contained within counties as defined by the us census, and health data are linked mostly at the municipality level. marika schwandt community organizers from the ontario coaliti~n again~t pove~, .along ":ith ~edical practitioners who have endorsed the campaign and have been mvolved m prescnbmg special diet needs for ow and odsp recipients, will discuss the raise the rates campaign. the organizati~n has used a special diet needs supplement as a political tool, meeting the urgent needs o.f .poor ~ople m toront~ while raising the issues of poverty as a primary determinant of health and nutrtnous diet as a preventative health mea· sure. health professionals carry the responsibility to ensure that they use all means available to them to improve the health of the individuals that they serve, and to prevent future disease and health conditions. most health practitioners know that those on social assistance are not able to afford nutritious foods or even sufficient amounts of food, but many are not aware of the extra dietary funds that are available aher consideration by a health practitioner. responsible nurse practitioners and physicians cannot, in good conscience, ignore the special needs diet supplement that is available to all recipients of welfare and disabiliry (ow and odsp). a number of toronto physicians have taken the position that all clients can justifiably benefit from vitamins, organic foods and high fiber diets as a preventative health measure. we know that income is one of the greatest predictors of poor health. the special needs diet is a health promotion intervention which will prevent numerous future health conditions, including chronic conditions such as cardiovascular disease, cancer, diabetes and osteoporosis. many communiry health centres and other providers have chosen to hold clinics to allow many patients to get signed up for the supplement at one time. initiated by the ontario coalition against poverty, these clinics have brought together commu· niry organizers, community health centers, health practitioners, and individuals, who believe that poverty is the primary determinant of poor health. we believe that rates must be increased to address the health problems of all people on social assistance, kids, elders, people with hiv/aids -everyone. even in the context of understaffing, it could be considered a priority activity that has potentially important health promotion benefits. many clients can be processed in a two hour clinic. most providers find it a very interesting, rewarding undertaking. in the ontario coalition for social justice found that a toronto family with two adults and two kids receives $ , . this is $ , below the poverty line. p - (c) the health of street youth compared to similar aged youth beth hayhoe and ruth ewert . lntrod~on: street youth are at an age normally associated with good health, but due to their risky ~hav ours and th~ conditions in which they live, they experience health conditions unlike their peer~ an more stable env r~nments. in addition, the majority of street youth have experienced significant physical, sexual ~nd em.ot onal abuse as younger children, directly impacting many of the choices they make around their physical and emotional health. we examined how different their health really is. . , methodl: using a retrospective analysis of the years of data gathered from yonge street mis· ~ • evergreen health centre, the top conditions of youth were examined and compared with national tren~s for similar aged youth. based on knowledge of the risk factors present in the group, rea· sons for the difference were examined. d' ~its: street youth experience more illness than other youth their age and their illnesses can bt . irect t ·~kc~ to the. conditions in which they live. long-term impacts of abus~ contribute to such signif· ~~nt t e t d~slpl air that youth may voluntarily engage in behaviours or lack of self care in the hope at t cir ve~ w perhaps come to a quicker end. concl non: although it has ion b k h th' dy clearly shows d'fi . h g ee~ no~n t at poverty negatively affects health, ~siu be used to make ; erence m t .e health of this particular marginalized population. the infonnanon can relates to th . ecommendatio.ns around public policy that affects children and youth, especially as it e r access to appropriate health care and follow up. p - (cl why do urban children · b gt . tarek hussain an adesh die: how to save our children? the traditional belief that urban child alid. a recent study (dhs d fr r~n are better off than rural children might be no longer v urban migrants are highata th om h c~untn~s i demonstrates that the child survival prospects of rural· er an t ose m their r j · · ·grants. in bangladesh, currently million ~r~ ~ gm and lower than those of urban non-idi million. health of the urban ~ p~e are hvmg m urban area and by the year , it would be so the popu at on s a key a eals that urban poor have the worse h h . concern. recent study on the urban poor rev ea t situation than the nation as a whole. this study shows that infant poster sessions v mortality among the urban poor as per thousand, which are above the rural and national level estimates. the mortality levels of the dhaka poor are well above those of the rest of the city's population but much of the difference in death rates is explained by the experience of children, especially infants. analyzing demographic surveillance data from a large zone of the city containing all sectors of the population, research showed that the one-fifth of the households with the least possessions exhibited u child mortality almost three times as high as that recorded by the rest of the population. why children die in bangladesh? because their parents are too poor to provide them with enough food, clean water and other basic needs to help them avoid infection and recover from illness. researchers believed that girls are more at risk than boys, as mothers regularly feed boys first. this reflects the different value placed on girls and boys, as well as resources which may not stretch far enough to provide for everyone. many studies show that housing conditions such as household construction materials and access to safe drinking water and hygienic toilet facilities are the most critical determinants of child survival in urban areas of developing countries. the present situation stressed on the need for renewed emphasis on maternal and child healthcare and child nutrition programs. mapping path for progress to save our children would need be done strategically. we have the policies on hand, we have the means, to change the world so that every child will survive and has the opportunity to develop himself fully as a healthy human being. we need the political will--courage and determination to make that a reality. p - (c) sherbourne health centre: innovation in healthcare for the transgendered community james read introduction: sherbourne health centre (shc), a primary health care centre located in downtown toronto, was established to address health service gaps in the local community. its mission is to reduce barriers to health by working with the people of its diverse urban communities to promote wellness and provide innovative primary health services. in addition to the local communities there are three populations of focus: the lesbian, gay, bisexual, transgendered and transexual communities (lgbtt); people who are homeless or underhoused; and newcomers to canada. shc is dedicated to providing health services in an interdisciplinary manner and its health providers include nurses, a nurse practitioner, mental health counsellors, health promoters, client-resource workers, and physicians. in january shc began offering medical care. among the challenges faced was how to provide responsive, respectful services to the trans community. providers had considerable expertise in the area of counselling and community work, but little in the area of hormone therapy -a key health service for those who want to transition from one gender to another. method: in preparing to offer community-based health care to the trans community it was clear that shc was being welcomed but also being watched with a critical eye. trans people have traditionally experienced significant barriers in accessing medical care. to respond to this challenge a working group of members of the trans community and health providers was created to develop an overall approach to care and specific protocols for hormone therapy. the group met over a one year period and their work culminated in the development of medical protocols for the provision of hormone therapy to trans individuals. results: shc is currently providing health care to registered clients who identify as trans individuals (march ) through primary care and mental health programs. in an audit of shc medical charts (january to september ) female-to-male (ftm) and male-to-female (mtf) clients were identified. less than half of the ftm group and just over two-thirds of the mtf group presented specifically for the provision of hormones. based on this chart audit and ongoing experience shc continues to update and refine these protocols to ensure delivery of quality care. conclusion: this program is an example of innovative community-based health delivery to a population who have traditionally faced barriers. shc services also include counselling, health promotion, outreach and education. p - (c) healthy cities for canadian women: a national consultation sandra kerr, kimberly walker, and gail lush on march , the national network on environment and women's health held a pan-canadian consultation to identify opportunities for health research, policy change, and action. this consultation also worked to facilitate information sharing and networking between canadian women working as urban planners, policy makers, researchers, and service workers on issues pertaining to the health of women living in canadian cities. methods: for this research project, participants included front-line service workers, policy workers, researchers, and advocates from coast to coast, including francophone women, women with disabilities, racialized women, and other marginalized groups. the following key areas were selected as topics for du.bnes i alto kading .:auk of end·sugr ieaal clileue ia singapore, accounting for more than so% of new can singapore (nkfs) to embark on a prevention program (pp) empo~r d ahc j u f dieir condition bttter, emphasizing education and disease sdf·managemen lkilla a. essennal camponenn of good glycaemic control. we sought explore the effects of a pecialijed edu.:a on pro· pun od glycacmic conuol, as indicated by, serum hba ic values budine serum hba ic values were determined before un so yean). ohew-ibmi ~ .nwm , wai hip ratio> l),up to primary and above secondary level education and those having om urine iclt showed that increasing hbalc levels ( ) had increasing urmary protein ( .± ; . ±i ih so± ) and crearinine (s .s ± s ± ; ioi± s) levels fbg rnults showed that the management nf d abetn m the nkfs preven· tion programme is effec;rive. results also indicated har hba le leve have a linnr trend wnh unnary protein and creatinine which are imponant determinants of renal diseate tal family-focused cinical palbway promoce politivc outcollln for ua inner city canu allicy ipmai jerrnjm care llctivirits in preparation for an infanr'' dilchargr honlr, and art m endnl lo improve effi.:k'fl.:tn of c.are. lere i paucity of tttran:h, and inconsi trncy of rnulta on ht-•m!*- of f m ly·fc"-'uw d nm a: to determinr whrthrr implrmentation of family.focuted c:pt n ntnn.tt.tl unit w"n mg an inner city ;ommunity drcl't'aki leftarh of lf•y (i.osi and rromclll'i family uo•fkllon and rt. j nest for dikhargr. md odt: family-focuk"d cpi data wm coll«ted for all infant• horn btrwttn and wft"k• t"lal mi atr who wrtt . dm ed to the ntonatal unit lmgdl of -.y . n. . day'o p c o.osi ind pma . d•mr., ho.nr . t . n. . ± i. i wb, p < o.os) wett n« fiamly f.lfrt n the pre.(]' poup. ~ .fxtmon icofn for famihn wrre high. and families noctd thc:y wnr mott prepued to ah thrar t..lby "'-· thett was .a cosi uving of s , (cdn) per patient d teharpd home n the pmi-cp poap c.-pated the p"''lfoup· cortclaion· lmplrmrnr.rion of family·foanrd c:p. in a nrona . i umt tc"fyidi an nnn an com· muniry decre.ned length of'"'" mft with a high dcgrft of family uujamon, and wrre coll~nt at least % percent of the kathmandu population lives in slum like conditions with poor access to basic health services. in these disadvantaged areas, a large proportion of children do not receive treatment due to inaccessibility to medical services. in these areas, diarrhea, pneumonia, and measles, are the key determinants of infant mortality. protein energy malnutrition and vitamin a deficiency persists and communicable diseases are compounded by the emergence of diseases like hiv/aids. while the health challenges for disadvantaged populations in kathmandu are substantial, the city has also experienced various forms of innovative and effective community development health programs. for example, there are community primary health centers established by the kathmandu municipality to deliver essential health services to targeted communities. these centers not only provide equal access to health services to the people through an effective management system but also educate them hy organizing health related awareness programs. this program is considered one of the most effective urban health programs. the paper/presentation this paper will review large, innovative, and effective urhan health programs that are operating in kathmandu. most of these programs are currently run by international and national ngos a) early detection of emerging diseases in urban settings through syndromic surveillance: data pilot study kate bassil of community resources, and without adequate follow-up. in november shelter pr.oviders ~et with hospital social workers and ccac to strike a working group to address some of th~ issues by mcre.asing knowledge among hospital staff of issues surrounding homelessness, and to build a stro?g workmg relationship between both systems in hamilton. to date the hswg has conducted four w~lkmg to~ of downtown shelters for hospital staff and local politicians. recently the hswg launched its ·~ool.k t for staff working with patients who are homeless', which contains community resources and gu dehnes to help with effective discharge plans. a scpi proposal has been submitted to incre~se the capacity of the hswg to address education gaps and opportunities with both shelters and hospitals around homelessness and healthcare. the purpose of this poster presentation is to share hamilton's experience and learnings with communities who are experiencing similar issues. it will provide for intera~tion around shared experiences and a chance to network with practitioners across canada re: best practices. introduction and objectives: canadians view health as the biggest priority for the federal government, where health policies are often based on models that rely on abstract definitions of health that provide little assistance in the policy and analytical arena. the main objectives of this paper are to provide a functional definition of health, to create a didactic model for devising policies and determining forms of intervention, to aid health professionals and analysts to strategize and prioritize policy objectives via cost benefit analysis, and to prompt readers to view health in terms of capacity measures as opposed to status measures. this paper provides a different perspective on health, which can be applied to various applications of health such as strategies of aid and poverty reduction, and measuring the health of an individual/ community/country. this paper aims to discuss theoretical, conceptual, methodological, and applied implications associated with different health policies and strategies, which can be extended to urban communities. essentially, our paper touches on the following two main themes of this conference: •health status of disadvantaged populations; and •interventions to improve the health of urban communities.methodology: we initially surveyed other models on this topic, and extrapolated key aspects into our conceptual framework. we then devised a theoretical framework that parallels simple theories of physkal energy, where health is viewed in terms of personal/societal health capacities and effort components.after establishing a theoretical model, we constructed a graphical representation of our model using selfrated health status and life expectancy measures. ultimately, we formulated a new definition of health, and a rudimentary method of conducting cost benefit analysis on policy initiatives. we end the paper with an application example discussing the issues surrounding the introduction of a seniors program.results: this paper provides both a conceptual and theoretical model that outlines how one can go about conducting a cost-benefit analysis when implementing a program. it also devises a new definition and model for health barred on our concept of individual and societal capacities. by devising a definition for health that links with a conceptual and theoretical framework, strategies can be more logically constructed where the repercussions on the general population are minimized. equally important, our model also sets itself up nicely for future microsimulation modeling and analysis.implications: this research enhances one's ability to conduct community-based cost-benefit analysis, and acts as a pedagogical tool when identifying which strategies provide the best outcome. p - (a) good playgrounds are hard to find: parents' perceptions of neighbourhood parks patricia tucker, martin holmes, jennifer irwin, and jason gilliland introduction: neighbourhood opportunities, including public parks and physical activity or sports fields hav~ been. iden.tified as correlates to physical activity among youth. increasingly, physical activity among children s bemg acknowledged as a vital component of children's lives as it is a modifiable determinant of childh~d obesity. children's use of parks is mainly under the influence of parents; therefore, the purpose of this study was to assess parents' perspectives of city parks, using london ontario as a case study.m~~: this qualitative study targeted a heterogeneous sample of parents of children using local parks w thm london. parents with children using the parks were asked for minutes of their time and if willing, a s.hort interview was conducted. the interview guide asked parents for their opinion 'of city parks, particularly the one they were currently using. a sample size of parents is expected by the end of the summer.results: preliminary findings are identifying parents concern with the current jack of shade in local parks. most parents have identified this as a limitation of existing parks, and when asked what would make the parks better, parents agree that shade is vital. additionally, some parents are recognizing the v poster sessions focused discussions during the consultation: . women in _poverty . women with disability . immi· grant and racialized women . the built and _physica_l environment. . . . . r its· participants voiced the need for integration of the following issues withm the research and policy :::na; t) the intersectional nature of urban women's health i~sues wh~ch reflects the reality of women's complex lives ) the multisectional aspect of urban wo_m~n s health, ss~es, which reflects the diversity within women's lives ) the interse~roral _dynamics within _womens hves and urban health issues. these concepts span multiple sectors -mdudmg health, educat n, and economics -when leveraging community, research, and policy support, and engaging all levels of government.policy jmplicatiom: jn order to work towards health equity for women, plans for gender equity must be incorporated nationally and internationally within urban development initiatives: • reintroduce "women" and "gender" as distinct sectors for research, analysis, advocacy, and action. •integrate the multisectional, intersectional, and intersecroral aspects of women's lives within the framework of research and policy development, as well as in the development of action strategies. • develop a strategic framework to house the consultation priorities for future health research and policy development (for example, advocacy, relationship building, evidence-based policy-relevant research, priority initiatives}.note: research conducted by nnewh has been made possible through a financial contribution from health canada. the views expressed herein do not necessarily represent the views of health canada.p - (c) drugs, culture and disadvantaged populations leticia folgar and cecilia rado lntroducci n: a partir de un proyecto de reducci n de daiios en una comunidad urbana en situ· aci n de extrema vulnerahilidad surge la reflexion sobre el lugar prioritario de los elementos sociocuhurales en el acceso a los servicios de salud de diferentes colectivos urbanos. las "formas de hacer, pensar y sentir" orientan las acciones y delimitan las posibilidades que tienen los individuos de definir que algo es o no problema, asf como tambien los mecanismos de pedido de ayuda. el analisis permanenre del campo de "las culturas cotidianas" de los llamados "usuarios de drogas" aporta a la comprension de la complejidad del tema en sus escenarios reales, y colabora en los diseiios contextualizados de politicas y propuestas socio-sanitarias de intervenci n, tornandolas mas efectivas.mitodos: esta experiencia de investigaci n-acci n que utiliza el merodo emografico identifica elementos socio estructurales, patrones de consumo y profundiza en los elementos socio-simb icos que estructuran los discursos de los usuarios, caracterizandolos y diferenciandolos en tanto constitutivos de identidades socia les que condicionan la implementaci n del programas de reduccion de daiios.resultados: los resultados que presentaremos dan cuenta de las caracteristicas diferenciadas v relaciones particulares ~ntre los consumidores de drogas en este contexto espedfico. a partir de este e~tudio de caso se mtentara co ? enzar a responder preguntas que entendemos significativas a la hora de pensar intcrvcnciones a la med da de poblaciones que comparten ciertas caracteristicas socio-culturales. (cuales serian las .motivaciones para el cambio en estas comunidades?, cque elementos comunitarios nos ayudan a i:nnstnur dema~~a? • cque tenemos para aprender de las "soluciones" que ellos mismos encuenrran a los usos problemat cos? methods: our study was conducted by a team of two researchers at three different sites. the mapping consisted of filling in a chart of observable neighbourhood features such as graffiti, litter, and boarded housing, and the presence or absence of each feature was noted for each city block. qualitative observations were also recorded throughout the process. researchers analyzed the compiled quantitative and qualitative neighbourhood data and then analyzed the process of data collection itself.results: this study reveals the need for further research into the effects of physical environments on individual health and sense of well-being, and perception of investment in neighbourhoods. the process reveals that perceptions of health and safety are not easily quantified. we make specific recommendations about the mapping methodology including the importance of considering how factors such as researcher social location may impact the experience of neighbourhoods and how similar neighbourhood characteristics are experienced differently in various spaces. further, we discuss some of the practical considerations around the mapping exercise such as recording of findings, time of day, temperature, and researcher safety.conclusion: this study revealed the importance of exploring conceptions of health and well-being beyond basic physical wellness. it suggests the importance of considering one's environment and one's own perception of health, safety, and well-being in determining health. this conclusion suggests that attention needs to be paid to the connection between the workplace and the external environment it is situated in. the individual's workday experience does not start and stop at the front door of their workplace, but rather extends into the neighbourhood and environment around them. our procedural observations and recommendations will allow other researchers interested in the effect of urban environments on health to consider using this innovative methodology. introduction: responding ro protests against poor medical attention for sexually assaulted women and deplorable conviction rates for sex offenders, in the late s, the ontario government established what would become over hospital-based sexual assault care and treatment centres (sactcs) across the province. these centres, staffed around the clock with specially trained heath care providers, have become the centralized locations for the simultaneous health care treatment of and forensic evidence collection from sexually assaulted women for the purpose of facilitating positive social and legal outcomes. since the introduction of these centres, very little evaluative research has been conducted to determine the impact of this intervention. the purpose of our study was to investigate it from the perspectives of sexually assaulted women who have undergone forensic medical examinations at these centres.method: women were referred to our study by sactc coordinators across ontario. we developed an interview schedule composed of both closed and open-ended questions. twenty-two women were interviewed, face-to-face. these interviews were approximately one-to-two hours in length, and were transcribed verbatim. to date, have been analyzed for key themes.results: preliminary findings indicate that most women interviewed were canadian born ( 'yo), and ranged in age from to years. a substantial proportion self-identified as a visible minority ( 'x.). approximately half were single or never married ( %) and living with a spouse or family of origin ( %). most were either students or not employed ( %). two-thirds ( %) had completed high school and onethird ( %) was from a lower socio-economic stratum. almost two-fifths ( %) of women perceived the medical forensic examination as revictimizing citing, for example, the internal examination and having blood drawn. the other two-thirds ( %) indicated that it was an empowering experience, as it gave them a sense of control at a time when they described feeling otherwise powerless. most ( %) women stated that they had presented to a centre due to health care concerns and were very satisfied ( % ) with their experiences and interactions with staff. almost all ( %) women felt supported and understood.conclusions: this research has important implications for clinical practice and for appropriately addressing the needs of sexually assaulted women. what is apparent is that continued high-quality medical attention administered in the milieu of specialized hospital-based services is essential. at the same time, we would suggest that some forensic evidence collection procedures warrant reevaluation. the study will take an experiential, approach by chroruclmg the impa~ of the transition f m the streets to stabilization in a managed alcohol program through the techruque of narrative i~:uiry. in keeping with the shift in thinking in the mental health fie!~ ~his stu~y is based on a paradigm of recovery rather than one of pathology. the "inner views of part c pants hves as they portray their worlds, experiences and observations" will be presented (charm~z, , ~· ~)-"i?e p~ of the study is to: identify barriers to recovery. it will explore the exj?cnence of ~n~t zanon pnor to entry into the program; and following entry will: explore the meanmg ~nd defirutto~s of r~overy ~~d the impact of the new environment and highlight what supports were instrumental m movmg pan apants along the recovery paradigm.p -st (a) treating the "untreatable": the politics of public health in vancouver's inner city introdudion: this paper explores the everyday practices of therapeutic programs in the treadnent of hiv in vancouver's inner city. as anthropologists have shown elsewhere, therapeutic programs do not siinply treat physical ailments but they shape, regulate and manage social lives. in vancouver's inner city, there are few therapeutic options available for the treatment of -ilv. public health initiatives in the inner city have instead largely focused on prevention and harm reduction strategies such as needle exchange programs, safe injection sites, and safer-sex education. epidemiological reports suggest that less than a quarter of those living with hiv in the downtown eastside (dtes) are taking antiretroviral therapies raising critical questions regarding the therapeutic economy of antiretrovirals and rights to health care for the urban poor.methods: this paper is drawn from ethnographic fieldwork in vancouver's otes neighborhood focusing on therapeutic programs for hiv treatment among "hard-to-reach" populations. the research includes participant-observation at inner city health clinics specializing in the treatment of hiv; semi· structured interviews with hiv positive participants, health care professionals providing hiv treatment, and administraton working in the field of inner city public health; and, lastly, observation at public meetings and conferences surrounding hiv treatment.r.awlts: hiv prevention and treatment is a central concern in the lives of many residents living in the inner city -although it is just one of many health priorities afflicting the community. concerns about drug resistance, cost of antiretrovirals, and illicit drug use means that hiv therapy for most is characterized by the daily observation of their medicine ingestion at health clinics or pharmacies. daily observed treatment (dot) is increasingly being adopted as a strategy in the therapeutic management of "untreatable" populations. dot programs demand a particular type of subject -one who is "compliant" to the rules and regimes of public health. over emphasis on "risky practices," "chaotic lives," and "~dh~rence" preve~ts the public health system from meaningful engagement with the health of the marginalized who continue to suffer from multiple and serious health conditions and who continue to experience considerable disparities in health.~ the ~ffec~s of hiv in the inner city are compounded by poverty, laclc of safe and affordable houamg, vanous llegal underground economies increased rates of violence and outbreaks of ~~~·~ly tr~nsmitted infections, hepatitis, and tuberculosi: but this research suggests 'that public health uunauves aimed at reducing health disparities may be failing the most vulnerable and marginal of citiztl s. margaret malone ~ vi~lence that occurs in families and in intimate relationships is a significant urban, ~unity, and pu~hc health problem. it has major consequences and far-reaching effects for women, ~~--renho, you~ sen on, and families. violence also has significant effects for those who provide and ukllc w receive health care violence · · i · · . all lasses, · is a soc a act mvolvmg a senous abuse of power. it crosses : ' : ' ~ s;nden, ag~ ~ti~, cultures, sexualities, abilities, and religions. societal responseshali ra y oc:used on identificatton, crisis intervention and services for families and individuajs.promoten are only "-"--:-g to add h · ' · i in intimate relationshi with"-~"'.". ress t e issues of violence against women and vjoence lenga to consider i~ m families. in thi_s p~per, i analyze issues, propose strategies, and note c~· cannot be full -...l'-~ whork towards erad canng violence, while arguing that social justice and equity y -. ucvcu w en thett are people wh mnhod: critical social theory, an analysis that addresses culturally and ethnically diverse communities, together with a population health promotion perspective frame this analysis. social determinants of health are used to highlight the extent of the problem of violence and the social and health care costs.the ottawa charter is integrated to focus on strategies for developing personal skills, strengthening community action, creating supportive environments, devdoping healthy public policies, and re-orientating health and social services. attention is directed to approaches for working with individuals, families, groups, communities, populations, and society.ratdts: this analysis demonstrates that a comprehensive interdisciplinary, multisectoral, and multifaceted approach within an overall health promoting perspective helps to focus on the relevant issues, aitical analysis, and strategies required for action. it also illuminates a number of interacting, intersecting, and interconnecting factors related to violence. attention, which is often focused on individuals who are blamed for the problem of violence, is redirected to the expertise of non-health professionals and to community-based solutions. the challenge for health promoters working in the area of violence in families and in intimate relationships is to work to empower ourselves and the communities with whom we work to create health-promoting urban environments. social justice, equiry, and emancipatory possibilities are positioned in relation to recommendations for future community-based participatory research, pedagogical practices for health care practitioners, and policy development in relation to violence and urban health. the mid-main community health center, located in vancouver british columbia (bc), has a diverse patient base reflecting various cultures, languages, abilities, and socio-economic statuses. due to these differences, some mid-main patients experience greater digital divide barriers in accessing computers and reputable, government produced consumer health information (chi) websites, such as the bc healthguide and canadian health network. inequitable access is problematic because patient empowerment is the basis of many government produced chi websites. an internet terminal was introduced at mid-main in the summer of , as part of an action research project to attempt to bridge the digital divide and make government produced chi resources useful to a broad array of patients. multi-level interventions in co-operation with patients, with the clinic and eventually government ministries were envisioned to meet this goal. the idea of implementing multi-level interventions was adopted to counter the tendency in interactive design to implement a universal solution for the 'ideal' end-user [ ), which discounts diversity. to design and execute the interventions, various action-oriented and ethnographic methods were employed before and during the implementation of the internet terminal. upon the introduction of the internet terminal, participant observation and interviews were conducted using a motion capture software program to record a digital video and audio track of patients' internet sessions. this research provided insight into the spectrum of patients' capacities to use technology to fulfil their health information needs and become empowered. at the mid-main clinic it is noteworthy that the most significant intervention to enhance the usefulness of chi websites for patients appeared to be a human rather than a technological presence. as demonstrated in other ethnographic research of community internet access, technical support and capacity building is a significant component of empowerment ( ). the mid-main wired waiting room project indicates that medical practitioners, medical administrators, and human intermediaries remain integral to making chi websites useful to patients and their potential empowerment. ( ) over the past years the environmental yo~th alliance has been of~ering a.youth as~t. mappin~ program which trains young people in community research and evaluation. wh ~st the positive expenenc~ and relationships that have developed over this time attest to the success of this program, no evaluations has yet been undertaken to find out what works for t.he youth, what ~ould be changed, and what long term outcomes this approach offers for the youth, their local community, and urban governance. these topics will be shared and discussed to help other community disorganizing and uncials governments build better, youth-driven structures in the places they live.p - (a) the world trade center health registry: a unique resource for urban health researchers deborah walker, lorna thorpe, mark farfel, erin gregg, and robert brackbill introduction: the world trade center health registry (wfchr) was developed as a public health response to document and evaluate the long-term physical and mental health effects of the / disaster on a large, diverse population. over , people completed a wfchr enrollment baseline survey, creating the largest u.s. health registry. while studies have begun to characterize / bealth impacts, questions on long-term impacts remain that require additional studies involving carefully selected populations, long-term follow-up and appropriate physical exams and laboratory tests. wtchr provides an exposed population directory valuable for such studies with features that make ita unique resource: (a) a large diverse population of residents, school children/staff, people in lower man· hattan on / including occupants of damaged/destroyed buildings, and rescue/recovery/cleanup work· ers; (b) consent by % of enrollees to receive information about / -related health studies; (c) represenration of many groups not well-studied by other researchers; (c) email addresses of % of enrollees; (d) % of enrollees recruited from lists with denominator estimates; and (e) available com· parison data for nyc residents. wfchr strives to maintain up-to-date contact information for all enrollees, an interested pool of potential study participants. follow-up surveys are planned.methods: to promote the wtchr as a public health resource, guidelines for external researcher.; were developed and posted on (www.wtcregistry.org) which include a short application form, a twopage proposal and documentation of irb approval. proposals are limited to medical, public health, or other scientific research. researchers can request de-identified baseline data or have dohmh send information about their studies to selected wfchr enrollees via mail or email. applications are scored by the wtchr review committee, comprised of representatives from dohmh, the agency for toxic subst~nces and disease registry, and wtchr's scientific, community and labor advisory committees. a data file users manual will be available in early fall .~suits: three external applications have been approved in , including one &om a non-u.s. ~esearcher, all requesting information to be sent to selected wtchr enrollees. the one completed mail· mg~~ wtchr enrollee~ (o , wfc tower evacuees) generated a positive survey response rate. three additional researchers mtend to submit applications in . wfchr encourages collaborations between researchers and labor and community leaders.conclusion: studies involving wtchr enrollees will provide vital information about the long· term health consequences of / . wtchr-related research can inform communities, researcher.;, policy makers, health care providers and public health officials examining and reacting to and other disasters. t .,. dp'"f'osed: thi is presentation will discuss the findings of attitudes toward the repeat male client iden· ie as su e a and substance us'n p · · · · i · 'd . . - g. articipants will learn about some identified effective strategies or service prov ers to assist this group of i · f men are oft · d bl men. n emergency care settings, studies show that this group en viewe as pro emaric patient d i r for mental health p bl h h an are more ikely to be discharged without an assessmen !) ea rofr ems t. an or er, more cooperative patients (forster and wu · hickey er al., · r y resu ts om this study suggest th · · ' ' l · d tel' mining how best to h . d at negative amtudes towards patients, difficu nes e · as well pathways l_e_ p patientsblan ~ck of conrinuity of care influence pathways to mental health care. • uc\:ome pro emat c when p ti k · che system. m a ems present repeatedly and become "get stuc id methods: semi-structured intervie d . · (n= ), ed nurses (n= ) other ed ;s were con ucted with male ed patients (n= ), ed phys oans ' sta (n= ) and family physicians (n= ). patients also completed a poster sessions v diagnostic interview. interviews were tape-recorded, transcribed verbatim and managed using n . transcripts were coded using an iterative process and memos prepared capture emergent themes. ethics approval was obtained and all participants signed a detailed informed consent form.introduction: urban settings are particularly susceptible to the emergence and rapid spread of nt•w or rare diseases. the emergence of infectious diseases such as sars and increasing concerns over the next influenza pandemic has heightened interest in developing and using a surveillance systt·m which detects emerging public health problems early. syndromic surveillance systems, which use data b, scd on symptoms rather than disease, offer substantial potential for this by providing near-real-rime data which are linked to an automated warning system. in toronto, we are piloting syndromic data from the · emergency medical services (ems) database to examine how this information can be used on an ongoing basis for the early detection of syndromes including heat-related illness (hri), and influenza-like-illness (ill). this presentation will provide an outline of the planned desi_gn of this system and proposed evaluation. for one year, call codes which reflect heat-related illness or influenza-like-illness will be selected and searched for daily using software with a multifactorial algorithm. calls will he stratified by call code, extracted from the -ems database and transferred electronically to toronto public health. the data will be analyzed for clusters and aberrations from the expected with the realtime outbreak and disease surveillance (rods) system, a computer-based public health tool for the early detection of disease outbreaks. this -ems surveillance system will be assessed in terms of its specificity and sensitivity through comparisons with the well-established tracking systems already in place for hr! and ill. others sources of data including paramedic ambulance call reports of signs and . this study will introduce complementary data sources t~ the ed ch e~ complamt an~ o~~rthe-counter pharmacy sales syndromic surveillance data currently bemg evaluated m ~ther ontar~o cltles. . syndromic surveillance is a unique approach to proactive(~ dete~tmg early c.hangesm the health status of urban communities. the proposed study aims to provide evidence of differential effectiveness through investigating the use of -ems call data as a source of syndromic surveillance information for hr! and ili in toronto. introduction: there is strong evidence that primary care interventions, including screening, brief advi<:e, treatment referral and pharmacotherapy are effective in reducing morbidity and mortality caused by substance abuse. yet physicians are poor at intervening with substance users, in part because of lack of time, training and support. this study examines the hypothesis that shared care in addictions will result in decreased substance use and improved health status of patients, as well as increased use of primary care interventions by primary care practitioners (pcps). methods: the addiction medicine service (ams) at st. joseph's health centre's family medicine department is in the process of being transformed from its current structure as a traditional consult service into a shared care model called addiction shared care (asc). the program will have three components: education, office systems and clinical shared care. as opposed to a traditional consult service, the patient will be booked with both a primary care liaison worker (pcl) and addictions physician. patients referred from community physicians, the emergency department and inpatient medical and psychiatric wards will be recruited for the study as well as pcps from the surrounding community. the target sample size is - physicians and a similar number of patients. after initial consult, patient will be recruited into the study with their consent. the shared-case model underlines the interaction and collaboration with the patient's main pcp. asc will provide them with telephone consults, advice, support and re-assessment for their patients, as well as educational sessions and materials such as newsletters and informational kits.results: the impact of this transition on our patient care and on pcp's satisfaction with the asc model is currently being evaluated through a grant provided by the ministry of health & long term care. a retrospective chart review will be conducted using information on the patient's substance use, er/clinic visits, and their health/mood status. pcp satisfaction with the program will be measured through surveys and focus groups. our cost-effectiveness analysis will calculate the overall cost of the program per patient..conclusion: this low-cost service holds promise to serve as an optimal model and strategy to improve outcomes and reduce health care utilization in addict patients. the inner city public health project introduction the inner city public health project (icphp) was desi.gned to explore new an~ innovative ways to reach marginalized inner city populations that par-t c pate m high health-nsk beha~ ors. much of this population struggles with poverty, addictions, mental illness and homelessness, creatmg barriers to accessing health services and receiving follow-up. this pro ect was de~igned to evaluat~ .~e success of offering clinics in the community for testing and followup of communicable diseases uuhzmg an aboriginal outreach worker to build relationships with individuals and agencies. v n(demographics~ history ~f testi~g ~nd immunization and participation in various health-risk behaviors), records of tesnng and mmumzat ons, and mterviews with partner agency and project staff after one year.. results: t~e chr ~as i~strumental in building relationships with individuals and partner agencies ' .° the c~mmun_ ~ re_sultmg m req~ests for on-site outreach clinics from many of the agencies. the increase m parnc pat n, the chr mvolvement in the community, and the positive feedback from the agen? staff de~onstrated that.the project was successfully creating partnerships and becoming increasingly integrated m the community. data collected from clients at the initial visit indicated that the project was reaching its target populations and highlighted the unique health needs of clients, the large unmet need for health services and the barriers that exist to accessing those services. ~usion: the outreach clinics were successful at providing services to target populations of high health-nsk groups and had great support from the community agencies. the role of the chr was critical to the success of the project and proved the value of this category of health care worker in an urban aboriginal population. the unmet health needs of this disadvantaged population support the need for more dedicated resources with an emphasis on reducing access barriers. building a caring community old strathcona's whyte avenue, a district in edmonton, brought concern about increases in the population of panhandlers, street people and homeless persons to the attention of all levels of government. the issue was not only the problems of homelessness and related issues, but feelings of insecurity and disempowerment by the neighbourhood residents and businesses. their concerns were acknowledged, and civic support was offered, but it was up to the community itself to solve the problem. within a year of those meetings, an adult outreach worker program was created. the outreach worker, meets people in their own environments, including river valley camps. she provides wrap-around services rooted in harm reduction and health promotion principles. her relationship-based practice establishes the trust for helping clients with appropriate housing, physical and/or mental health issues, who have little or no income and family support to transition from homelessness. the program is an excellent example of collaboration that has been established with the businesses, community residents, community associations, churches, municiple services, and inner-city agencies such as boyle street community services. statistics are tracked using the canadian outcomes research institute homes database, and feedback from participants, including people who are street involved. this includes an annual general meeting for community and people who are homeless. the program's holistic approach to serving the homeless population has been integral, both in creating community awareness and equipping residents and businesses to effectively interact with people who are homeless. through this community development work, the outreach worker engages old strathcona in meeting the financial and material needs of the marginalized community. the success of this program has been surprising -the fact is that homeless people's lives are being changed; one person at a time and the community has been changed in how they view and treat those without homes. over two years, the program has successfully connected with approximately seventy-five individuals who call old strathcona home, but are homeless. thirty-six individuals are now in homes, while numerous others have been assisted in obtaining a healthier and safer lifestyles by becoming connected with other social/health agencies. the program highlights the roots of homelessness, barriers to change and requirements for success. it has been a thriving program and a model that works by showing how a caring community has rallied together to achieve prosperous outcomes. the spn has created models of tb service delivery to be used m part~ers~ p with phannaceunca compa-. · · -. t' ns cooperatives and health maintenance orgamzanons (hmos). for example, the mes, c v c orgamza , . · b tb d' · spn has established a system with pharmaceutical companies that help patients to uy me cmes at a special discounted rate. this scheme also allows patients to get a free one-_month's worth of~ dru_g supply if they purchase the first months of their regimen. the sy_s~e~s were ~es gned to be cm~pattble with existing policies for recording and documentation of the ph hppme national tuberculosis program (ntp). aside from that, stakeholders were also encouraged to be dots-enabled through the use of m~nual~ and on-line training courses. the spn initiative offers an alternative in easing the burden of tb sc:rv ce delivery from rhe public sector through the harnessing of existing private-sector (dsos). the learnmgs from the spn experience would benefit groups from other locales that _work no~ only on ~ but other health concerns as well. the spn experience showcases how well-coordinated private sector involvements help promote social justice in health delivery in urban communities.p - (c) young people in control; doing it safe. the safe sex comedy juan walter and pepijn v. empelen introduction: high prevalence of chlamydia and gonorrhoea have been reported among migrants youth in amsterdam, originating from the dutch antilles, suriname and sub-sahara africa. in addition, these groups also have high rates of teenage-pregnancy (stuart, ) and abortions (rademakers ), indicating unsafe sexual behaviour of these young people. young people (aged - ) from the so· called urban scene (young trendsetters in r&b/hip hop music and lifestyle) in amsterdam have been approached by the municipal health service (mhs) to collaborate on a safe sex project. their input was to use comedy as vehicle to get the message a cross. for the mhs this collaboration was a valuable opportunity to reach a hard-to-reach group.mdhods: first we conducted a need assessment by means of a online survey to assess basic knowledge and to similtaneously examine issues of interest concerning sex, sexuality, safer sex and the opposite sex. second, a small literature study was conducted about elements and essential conditions for succesful entertainment & education (e&e) (bouman ), with as most important condition to ensure that the message is realistic (buckingham & bragg, ) . third a program plan was developed aiming at enhancing the stl/hiv and sexuality knowledge of the young people and addressing communication and educational skills, by means of drama. subsequently a safe sex comedy show was developed, with as main topics: being in love, sexuality, empowerment, stigma, sti, hivand safer sex. the messages where carried by a mix of video presentation, stand up comedy, spoken word, rap and dance.results: there have been two safe sex comedy shows. the attendance was good; the group was divers' with an age range between and year, with the majority being younger than year. more women than men attended the show. the story lines were considered realistic and most of the audients recognised the situations displayed. eighty percent of the audients found the show entertaining and % found it edm:arional. from this %, one third considers the information as new. almost all respondents pointed our that they would promote this show to their friends.con.clusion: the s.h<_>w reached the hard-to-reach group of young people out of the urban scene and was cons d_ered entert~mmg, educational and realistic. in addition, the program was able in addressing important issues, and impacted on the percieved personal risk of acquiring an sti when not using condoms, as well as on basic knowledge about stl's. introduction: modernity has contributed mightily to the marginality of adults who live with mental illnesses and the subsequent denial of opportunities to them. limited access to social, vocational, educational, and residential opportunities exacerbates their disenfranchisement, strengthening the stigma that has been associated with mental illness in western society, and resulting in the denial of their basic human rights and their exclusion from active participation in civil society. the clubhouse approach tn recovery has led to the reduction of both marginality and stigma in every locale in which it has been implemented judiciously. its elucidation via the prism of social justice principles will lead to a deeper appreciation of its efficacy and relevance to an array of settings. methods: a review of the literature on social justice and mental health was conducted to determine core principles and relationships between the concepts. in particular, fondacaro and weinberg's ( ) conceptualization of social justice in community psychology suggests the desirability of the clubhouse approach in community mental health practice. a review of clubhouse philosophy and practice has led to the inescapable conclusion that there is a strong connection between clubhouse philosophy-which represents a unique approach co recovery--and social justice principles. placing this highly effective model of community mental health practice within the context of these principles is long overdue. via textual analysis, we will glean the principles of social justice inherent in the rich trove of clubhouse literature, particularly the international standards of clubhouse development.results: fondacarao and weinberg highlight three primary social justice themes within their community psychology framework: prevention and health promotion; empowerment, and a critical pnsp<"<·tive. utilizing the prescriptive principles that inform every detail of clubhouse development and th<" movement toward recovery for individuals at a fully-realized clubhouse, this presentation asserts that both clubhouse philosophy and practice embody these social justice themes, promote human rights, and empower clubhouse members, individuals who live with mental illnesses, to achieve a level of wdl-heing and productivity previously unimagined.conclusion: a social justice framework is critical to and enhances an understanding of the clubhouse model. this model creates inclusive communities that lead to opportunities for full partic pil!ion civil society of a previously marginalized group. the implication is that clubhouses that an· based on the international standards for clubhouse programs offer an effective intervention strategy to guarantee the human rights of a sizable, worthy, and earnest group of citizens. to a drastic increase in school enrollment from . million in to . million in .s. however, while gross enrollment rates increased to °/., in the whole country after the introduction of fpe, it remained conspicuously low at % in the capital city, nairobi. nairobi city's enrollment rate is lower .than thatof all regions in the country except the nomadic north-eastern province. !h.e.d sadvantage of children bas_ed in the capital city was also noted in uganda after the introduction of fpe m the late s_-many_ education experts in kenya attribute the city's poor performance to the high propornon of children hvmg m slums, which are grossly underserved as far as social services are concerned. this paper ~xammes the impact of fpe and explores reasons for poor enrollment in informal settlements m na rob city. methods: the study utilizes quantitative and qualitative schooling data from the longitudinal health and demographic study being implemented by the african population and health research center in two informal settlements in nairobi. descriptive statistics are used to depict trends in enrollment rates for children aged - years in slum settlements for the period - . results: the results show that school enrollment has surprisingly steadily declined for children aged - while it increased marginally for those aged - . the number of new enrollments (among those aged years) did not change much between and while it declined consistently among those aged - since . these results show that the underlying reasons for poor school attendance in poverty-stricken populations go far beyond the lack of school fees. indeed, the results show that lack of finances (for uniform, transportation, and scholastic materials) has continued to be a key barrier to schooling for many children in slums. furthermore, slum children have not benefited from fpe because they mostly attend informal schools since they do not have access to government schools where the policy is being implemented.conclusion: the results show the need for equity considerations in the design and implementation of the fpe program in kenya. without paying particular attention to the schooling needs of the urban poor children, the millennium development goal aimed at achieving universal primary education will remain but a pipe dream for the rapidly increasing number of children living in poor urban neighborhoods.ps- (c) programing for hiv/aids in the urban workplace: issues and insights joseph kamoga hiv/aids has had a major effect on the workforce. according to !lo million persons who are engaged in some form of production are affectefd by hiv/aids. the working class mises out on programs that take place in communities, yet in a number of jobs, there are high risks to hiv infection. working persons sopend much of their active life time in workplaces and that is where they start getting involved in risky behaviour putting entire families at risk. and when they are infected with hiv, working people face high levels of seclusion, stigmatisation and some miss out on benefits especially in countries where there are no strong workplace programs. adressing hiv/aids in the workplace is key for sucessfull responses. this paper presents a case for workplace programing; the needs, issues and recommendations especially for urban places in developing countries where the private sector workers face major challenges. key: cord- -uftc inx authors: nan title: abstract of th regional congress of the isbt date: - - journal: vox sang doi: . /vox. sha: doc_id: cord_uid: uftc inx nan in the fin de siecle was heavily concentrated in vienna. freud, boltzmann, schr€ odinger and mach might be the first names to find, whenever one cites austrian scientists. but more related to transfusion are the noble prize winners max perutz and karl landsteiner. landsteiner s fate illustrates the brain drain beginning in the early s escalating in with the "anschluss", which lead to the forced emigration of many scientists. a loss which was not regenerated in the post war years and was further aggravated by dubious and often undisclosed relations and scandals in the nazi-era. all together this leads to a severe loss of credibility and productivity of universities across decades. opening university access in the early s and intensive historical work-up of scandals transformed the austrian universities to open and effective scientific institutions driving innovation in the country. austria has achieved a great economic deal in recent decades, which was accelerated by the eu membership in . as a result of strong long-term economic performance, the country's gross domestic product (gdp) per capita is the eighth highest among oecd countries and fourth in the eu . levels of poverty and income inequality are both below the oecd average. investment in research and development (r&d) increased since the eu accession, when austria's r&d intensity (aggregate r&d expenditure as a percentage of gdp) was well below the oecd average and significantly far lower than switzerland -a country to which austria prefers comparison. the eu target of % r&d intensity was first met in and is the sixth highest among oecd countries and the second highest in the eu . austria showed the second highest increase in r&d intensity of all oecd countries, exceeded only by korea. the rapid expansion was matched by a similar increase in human resources and scientific output of universities. austrian science in quantum mechanics, quantum communication and information is world renown. vienna is a major biotech hub, as is linz in mathematics and mechatronics and graz in automotive and production technologies. austria has been a net resource recipient in the horizon and the preceding th framework programme. small and mediumsized enterprises show a high propensity to co-operate with universities and other research organisations and more and more included in scientific grant schemes. vienna is the largest student city in the german-speaking world and consistently ranks among the top cities in the world on quality-of-life indices. as austria possesses globally recognised cultural attractions ranging from famed salzburg festival to the vienna new year concert its inhabitants are not aware of the progress made in r&d and how thriving innovation is going on in their country. they still love to show their cultural heritage and events and impress the world with some kind of eternal sound of music. patients with refractory b-cell malignancies as non-hodgkin lymphomas (nhl) resistant to standard therapies have a dismal prognosis. the outcome is even poorer in patients relapsing after autologous stem cell transplantation. most of these patients do not qualify for an allogeneic hematopoietic cell transplantation (hct) due to refractory disease, lack of a suitable allogeneic donor, higher age or cumulative toxicity of previous chemotherapy. despite patients undergoing allogeneic hct normally profit from a graft-versus -lymphoma effect, overall survival in patients with nhl after hct remains short. a similar situation can be observed for patients with acute lymphoblastic leukemia (all). therefore novel treatment modalities are urgently needed. chimeric antigen receptor (car)-t cells, a new class of cellular immunotherapy involving ex vivo genetic modification of t cells to incorporate an engineered car have been used in clinical trials. in the majority of studies b-cell malignancies treated with cd targeting car-t cells have been analyzed. austria had the advantage to participate in two international trials in the past and is currently involved in further car-t studies. recently, results from cd directed car-t cell trials with an increased follow-up of patients led to fda (food and drug administration) and ema (european medicines agency) approval of tisagenlecleucel and axicabtagene ciloleucel. common adverse events (aes) include cytokine release syndrome and neurological toxicity, which may require admission to an intensive care unit, b cell aplasia and hemophagocytic lymphohistiocytosis. these aes are manageable when treated by an appropriately trained team following established algorithm. in this presentation, results of four large phase ii cd car-t cell trials for patients with nhl and all and focus on aes is summarized. preoperative anemia is a known risk factor for increased perioperative morbidity and mortality in patients undergoing major surgery. previous studies have not only shown higher in-hospital mortality, but also an increased hospital length of stay, greater postoperative admission rates to intensive care and prolonged use of mechanical ventilation and intensive care resources in patients with anemia compared to those with normal preoperative hemoglobin concentrations. about % of patients scheduled for major surgery suffer from preoperative anemia. this figure is even higher in patients requiring orthotopic liver transplantation, where up to % of all patients are diagnosed with anemia prior to surgery. transfusion of packed red blood cells (prbcs) is commonly used to correct anemic hemoglobin values. however, transfusion of prbcs has been associated with increased morbidity and mortality in patients undergoing cardiac, orthopedic, and abdominal surgery. additionally, transfusion of prbcs is associated with a greater incidence of postoperative acute kidney injury in patients undergoing orthotopic liver transplantation. as preoperative anemia might increase the perioperative use of prbcs, negative effects observed after prbc transfusions might even be augmented. data on the influence of preoperative anemia on morbidity and mortality after orthotopic liver transplantation are limited. thus, we retrospectively analyzed the association of preoperative anemia and mortality in adult patients undergoing orthotopic liver transplantation at our institution. in addition, we examined the influence of anemia on perioperative parameters such as transfusion requirements, surgical complications, early allograft dysfunction, acute kidney injury, and the need for renal replacement therapy. based on the results obtained in the retrospective analysis, an ongoing prospective randomized clinical trial was initiated. the two suspensive treatments in sickle cell disease (scd) are hydroxycarbamide, inducing the production of the functional hbf, normally repressed at birth, and red blood cell (rbc) transfusion, a critical component of scd management. however, rbc transfusion is not without risk. repeat exposure to allogeneic rbcs can result in the development of rbc alloantibodies which can make it difficult to find compatible rbcs for future transfusions. however, the main concern of alloimmunization is the development of hemolytic transfusion reaction, with in the most severe cases, hyperhemolysis, leading to multi organ failure and death in % of the cases. the prevention of this life threatening condition must be based on risk factors. however, although some risk factors, such as alloimmunization, have been identified, much of the mechanism underlying dhtr remains a mystery, particularly in severe cases presenting hyperhemolysis. here we will describe the current and future development to prevent and treat this severe syndrome in order to decrease exposure to transfusion in scd but also improve red blood cell quality, some new products are developed. oxidative damage is one of the parameter that could be diminished. some work is also ongoing to prevent filter blockage during leucodepletion of precious rbcs units from afro-caribbean donors carrying the sickle cell trait. finally, in countries with higher risks of transmission of infectious disease, treatment of red blood cell units against infectious agents can be discussed. the only current curative treatment of scd is hematopoietic stem cell transplantation (hcs). however, the occurrence, frequency, and effects of immune hematologic complications in hcs remain and will be discussed. finally, gene therapy is a real hope as a definitive curative treatment. clinical trials are ongoing in france and will be discussed as well as the remaining place of transfusion in this therapeutic. in the context of the chronic myeloid leukemia (cml), we have hypothesized that quiescent leukemic hematopoietic stem cells (hsc) compartment, escaping to the current tyrosine kinase inhibitors (tkis) treatment, in part associated in the molecular relapse, may be targeted by cart-cells immunotherapy. gene expression profiling studies have established that a cell surface biomarker il- rap is expressed by the leukemic but not by the normal cd + /cd -hsc. this talk will focus of the whole process of development of a cart-cells starting from recombinant il- rap protein mice immunization to produce a specific monoclonal antibody (mab), to the proof of concept demonstration, before moving into the clinic. we produced and selected a specific anti-il- rap mab (#a c clone, diaclone sa, besanc ßon, france). after molecular characterization of antigen-binding domain, nucleotide sequences were fused with rd generation t cell activation coding sequences and cloned as a single chain into a lentiviral backbone comprising a safety switch suicide gene icasp (inducible caspase ) and a monitoring/selection cell surface marker Δcd . we demonstrated in-vitro and in an in-vivo xenograft murine model that il- rap car t cells can be activated in the presence of il- rap+ cell lines or primary cml cells, secrete pro-inflammatory cytokines, degranulate and specifically killing them. we also demonstrated that multi-tkis treatment over a -year period does not affect transduction efficiency of cml patient t-cells by il- rap car vector and that autologous cart-cells are able to target il- rap+ leukemic primary hsc. "off-tumor-on target" toxicity prediction, by studying il- rap expression on a tissue macroarray comprising normal human tissues ( donors) , with #a c , detected various il- rap intensity staining in only few tissues. regarding the healthy hematopoietic system, #a c flow cytometry staining did not detect hematopoietic cells, except monocytes that express poorly il- rap. as expected, monocyte subpopulation is targeted by autologous il- rap cart cells (ratio e: t = : ), but at a lower level that il- rap cml cell line. in-vivo investigation of specific toxicities of autologous il- rap cart-cells against hsc and/or immune cells on a human-cd + cord blood cell engrafted/nog murine model, but also by an in-vitro cd + colony forming unit assay didn't reveal any significant toxicities in immunocompetent cell subpopulations, suggesting that healthy cd + hsc are not affected. finally, to overcome potential toxicity, functionality of the icasp / rimiducid â safety switch was demonstrated in-vitro but also in-vivo in a nsg tumor xenograft model, showing that, when activate, the system is able to eliminate more than % of cart-cells, after exposure to ap . in conclusion, based on cml model, we demonstrated that il- rap is an interesting target for cart-cell immunotherapy, with a limited "on target, off tumor" predictable toxicity. next step will be the up-scaling of the process in order to match with the use in human regarding also the regulatory requirements. this strategy may be applied, in the future, in other hematological malignancies. mortality ranges from to % for trauma victims with severe bleeding and is largely dependent on the transfusion therapy from which they can benefit. the nature of this therapy has an impact on prognosis with a halving of mortality when the plasma/prbc ratio is greater than ½ and a decrease of about % when the proportion of platelets transfused is close to that of whole blood. the speed with which such therapy is actually administered has a major impact as well with an increase in mortality of % for each minute of delay in making the entire therapy available. this can be explained mainly by the fact that the probability of death of these patients is greater within minutes of their admission to hospital with a median time to death of h after admission. to allow plasma, platelets and prbc to be made available in a timely manner, north american trauma centers have mandated that trauma centers have massive transfusion packs at the patient's bedside within min. to further simplify and speed up logistics from distribution to transfusion, several trauma centers now use whole blood stored at °c. this return of an "old" product is largely inspired by military experience where whole blood is mainly used "warm" immediately after collection with compelling evidence of its effectiveness. its return to civilian practice requires the ability to deleukocyte it while preserving platelets and to store it while maintaining their hemostatic functions. good quality data shows this is achievable and several clinical studies are planned to begin in the coming months. in france, the french blood establishment and the french army are cooperating to initiate the prospective randomized non-inferiority storhm trial (sang total pour la r eanimation des h emorragies massives) which will be comparing whole blood to separate blood components in an / / ratio in severely bleeding trauma patients. the primary endpoint will be a thromboelastographic parameter (maximum amplitude) assessed at the th hour after admission. secondary endpoints will include early and overall mortality, lactate clearance (reflection of the effectiveness of resuscitation) and h organ failure. this trial will be recruiting patients in french trauma centers and is planned to be initiated second half of . local/neighbours day: innovation in germany c- - mesenchymal stromal cells for regenerative therapy bm-msc / asc obtained from these protocols have been characterized in detail in preclinical evaluations. manufacturing licenses for msc and asc and a platelet-derived growth factor concentrate have been obtained and they have been explored in several clinical trials for treatment of bone defects (ortho-ct : eudract number: - - ; ortho-ct : eudract number: - - ; maxillo : eudract number: - - ) . we will summarize results of completed clinical trials which confirmed feasibility and safety of autologous msc /asc treatment and provided evidence for efficacy (gjerde et al, stem cell res. introduction: in vitro produced megakaryocytes (mks) may serve as source to produce platelets (plts) ex vivo or in vivo. we have established a strategy to differentiate mks from induced pluripotent stem cells (ipscs) in bioreactors. this study aimed at the large-scale production of mks using microcarriers to increase the mk yield and to characterize their phenotype and functionality after irradiation as a method to decrease possible safety concerns associated to the ipsc origin. methods: ipscs were cultured in an aggregate form in presence or absence of microcarriers using ml stirred flasks. cells were differentiated into mks using tpo, scf and il- in apel medium for a period of days. non-irradiated or irradiated ipsc-derived mks were analysed for polyploidy, phenotype and proplt production using flow cytometry and fluorescence microscopy. also, plt-production was investigated in vivo. non-irradiated or irradiated mks were transfused to nod/ scid/il- rcc-/-mice and blood was analyzed for human plts. results: differentiation of mks in presence of microcarriers resulted in an -fold increase of mks per ipsc in comparison to only aggregates. this resulted in mean of total mk harvest of . ae . in microcarrier-assisted bioreactors in comparison to . ae . mks collected from bioreactors containing only aggregates. interestingly, mks produced in microcarrier-assisted bioreactors showed higher proplt formation capacity than mks derived from only aggregates bioreactors. mk phenotype and dna content was comparable between mks derived from both types of bioreactors. irradiation of mks did not affect their phenotype and capability to form proplts or plts after transfusion into nod/scid/il- rcc -/mice. conclusion: microcarriers showed to significantly increase the yield of ipsc-derived mks in stirred bioreactors to clinically relevant numbers. this may facilitate the use of ipsc-derived mk for ex vivo production of plts, direct transfusion or for innovative mk-based regenerative therapies. although the rosetta stone, found by the troops of napoleon in egypt near the city of rosetta (rashid) contains only a small amount of text in three languages it was key in deciphering hieroglyphs. the rosetta mission tried to achieve something similar: by looking at a tiny body its goal was to decipher the origin of the solar system, planets including earth and life. after more than years the rosetta spacecraft softly crashlanded on comet churyumov-gerasimenko on september , . it has travelled billions of kilometers, just to study a small ( km diameter), black boulder named p/ churyumov-gerasimenko. the results of this mission now seem to fully justify the time and money spent in the last decades on this endeavor. where are we from? where are we going? are we alone in the universe? these are some of the big questions. in this talk i will show which answers we got from rosetta and comet chury. we follow the pathway of the material which makes up our solar system from a dark cloud to the solar nebula and finally to planets and life. i will show that indeed we are the result of stardust and that what happened here may happen elsewhere in the universe. cells, tissues and entire organs can collectively be seen as "living drugs". genetically unaltered cells are routinely used in clinical practice to treat diseases as diverse as anemia, bleeding disorders, leukemia and organ failure. ground-breaking advances in genetic and genome engineering technologies are propelling cell therapies to the frontline of medical research and practice. the hematopoietic system is particularly amenable to genetic engineering because specific cell types can be purified based on the expression of specific surface proteins and the ability to culture and expand cells ex vivo. the recent unprecedented clinical success of killer t cells reprogrammed by chimeric antigen receptors (cars) to attack cd expressing tumor cells demonstrates the power of immunotherapy with genetically engineered immune cells. however, given the rapid development of novel genome engineering and synthetic biology tools we are likely only at the beginning of a new era of engineered cellular therapies. i will present recent progress in immune cell reprogramming, gene correction, safety aspects and remaining challenges such as manufacturing. d- - cell free nucleic acids (cfna) circulate in the plasma of all individuals and are thought to be released by host and foreign cells into the circulation. after fractionation by centrifugation, cfnas can be extracted from the supernatant of whole blood samples or manufactured blood products. these dna or rna sequences can be of human, bacterial, viral or fungal origin. most of them are human double stranded dnas. research on cfnas is increasing, thanks to technological advancements in molecular biology. some of their results are already implemented in clinical practice in the areas of prenatal diagnosis, oncology and infectious diseases. the latter investigation focuses on the exploration of non-human cfnas, the field of metagenomics. high throughput sequencing associated with bioinformatics, the so-called new generation sequencing (ngs), has sped up the investigations of non-human cfnas. this tool provides the opportunity to classify cfnas into a human or non-human category, and then to identify them. it is thus possible to explore simultaneously the whole landscape of bacterial, viral and fungal populations. presently, ngs of human blood has already proven its feasibility and its value in identifying emerging viruses or investigating clinical cases of fever of unknown etiology. ngs of cfnas is also particularly effective in analyzing the different genotypes of a virus in case of a co-infection (e.g. hepatitis c virus). studying cfnas with the new molecular technologies is therefore of great importance in transfusion medicine, especially regarding security and clinical transfusion reactions. first, transfusion transmitted infections are the most feared adverse complications. second, febrile non-hemolytic transfusion reactions are also the most frequently reported adverse events in hemovigilance systems and their physiological mechanism -if only one-remains not clearly elucidated. investigating cfnas could thus improve our understanding and strategy aiming at reducing those two clinical adverse events. surveying comprehensively the composition of circulating infectious agents in a blood product by ngs technology could be very interesting for investigating a severe febrile transfusion reaction. moreover, when the costs of analysis will be reduced, it might be possible to screen prospectively and regularly the whole metagenomics of asymptomatic blood donors, in addition to the classical epidemiological surveillance. for instance, in a study testing a ngs method on manufactured fresh frozen plasmas, an astrovirus (mlb ) has been identified. finally, it is the responsibility of transfusion physicians implicated in the manufacturing of blood products to ensure that cfnas within a blood product do not have a clinical impact on the innate immunity of the recipients. according to recent research in vitro, cfnas purified from blood products can induce the transcription of inflammatory cytokines by mononuclear cells. as nonhuman cfna have an effect on toll-like receptors (tlr-linked inflammatory pathways), it would be also relevant to insure that donor's cfnas have no significant effect on the immune system of the recipient. in conclusion, cfnas are very diverse molecules contaminating blood products. technological progress makes now their investigation more available. besides being useful markers of infection in asymptomatic donors, their impact on the recipients' immunity should be further investigated. an active life and regular training is part of a healthy life style and for many this includes participation in endurance exercise competition at different levels. thus, it is highly relevant to know how a blood donation affects exercise performance and how close this can done to an endurance competition. endurance exercise performance is determined by many factors, but three of the primary are maximal oxygen uptake, the relative load that an individual can sustain over time and finally the efficiency of movement in the given discipline. over the years, a number of studies have sampled blood volumes ranging from - ml and applied different methodological approaches to measure maximal oxygen uptake over a recovery period ranging between - days. overall, the general finding is a reduction in blood haemoglobin and an attenuated maximal oxygen uptake as well endurance performance after blood donation. in normal to well-trained men maximal oxygen uptake and performance was normalized after two weeks in one study after a normal blood donation ( / ml), but remained attenuated after four weeks in another study, despite the change in blood haemoglobin concentration was similar and the design and methodology also similar in the two studies. in addition to maximal oxygen uptake the relative load that can be tolerated during exercise is probably also attenuated, through a decreased arterio-venous oxygen extraction, but the available data is very limited. the first part of this talk will highlight the major findings and discuss some of the methodological issues that complicate interpretation and conclusions. there are sex differences in circulating blood volume, haemoglobin concentration, haematocrit and hormone levels and thus it is entirely possible that there is a sex difference in the effect of blood donation on physical performance and the recovery after blood donation. in addition to the basic physiological sex differences, there is also a higher prevalence of iron deficiency in premenopausal women, physically active women and women donating blood. therefore, we studied the influence of a standard ml blood donation on maximal oxygen uptake and endurance performance and the subsequent recovery in physically active women. we observed that in iron sufficient women blood haemoglobin concentration and maximal oxygen uptake were back to baseline days after blood donation, but endurance performance was normalized already after days. the second part of this talk will discuss the sex differences in the effect of blood donation on maximal oxygen uptake and endurance performance. overall, the available data suggest that, with a careful conservative approach, - weeks are needed after a normal blood donation to be fully recovered to participate in endurance exercise competitions. more than one in ten attempts to donate blood result in a temporary deferral, due to concerns about the impact of the donation on the donor or recipient. there is well established evidence that temporary deferrals impact negatively on donors, with a large proportion of those deferred failing to return at the end of the deferral period. this presentation provides an overview of deferrals from the donor perspective, describing the likelihood of receiving a deferral for different donor subgroups. the impact of temporary deferrals on the future donation of donors, considering both short-term and longer-term donation patterns, will also be reviewed, outlining which donors are at highest risk of non-return following a deferral, and what is known about the accumulative impact of multiple deferrals on donors. several hypotheses have been proposed to account for the strong negative impact of deferrals on donor behaviour, and there is preliminary evidence of psychological factors, such as emotional reactions, predicting intention to return. research is also beginning to emerge on the effectiveness of tailored interventions to mitigate the impact of deferrals on donor behaviour. the evidence for these preventative interventions, and for strategies to reactive donors once they have lapsed post-deferral, will be reviewed. recommendations for blood centres will be made, as well as suggestions for future research to address continuing gaps in knowledge. in his influential study "the gift relationship" ( ) , richard titmuss coined the idea of voluntary, non-paid, blood donation being the gift of life for a fellow citizen. this metaphor has been powerful in mobilizing donors (busby ) . it conveys a direct relationship between blood donation and patients' vitality, as well as a difference between gains and costs. as the gift of life, blood donation is seen to symbolize pure altruism and promoting solidarity between strangers. but can we apply the metaphor as successfully into donating blood for research? we asked a group of finnish blood donors what they would think if the frc blood service invited them to give a blood sample and personal information for research. the blood donors were usually willing to contribute to research for the public benefit, because they saw great potential in science to create solutions to help patients in the future. however, based on our interview data and previous research, we suggest that the analogy between gift of life and donation for research did not work all the way. the metaphor fails to address donors' questions on new types of relationships, interests and risks related to the use of personal data for research. left unanswered these could discourage donating for research. hence, we argue that the gift of life metaphor is not applicable to donor recruitment at the research context. in this presentation we wish to look for a better metaphor for donation for research that blood services collecting research data could apply. academy day: transfusion challenges in patients with sickle cell disease a- - immunohaematological features of patients with sickle cell disease (lfa) should be considered as polymorphic antigens in the african population and these lfa are not present in most commercial panels. the situation is even more complicated when recipients lack high-frequency antigens, the most common ones being hr-, hr b -, sec-, u neg , u+ var , js(b-), (hy-), and jo(a-). finally, there is a high rh diversity among people of african descent. because they harbor variant alleles and/or partial rh antigens, they are at risk of developing alloantibodies. in this setting, screening for partial rh antigens makes sense. the figures illustrating this diversity vary with the approach used. one of them is to take into consideration rhd or rhce*ce variant alleles. in several american studies, their prevalence was estimated to be - % and - %, respectively. other teams take into consideration d, c and e partial antigens. their prevalence was estimated to be . - %, . - . %, . - . %, respectively, and the alloimmunization rates were . %, . - %, . %, respectively. as a result of these phenotype discrepancies, scd patients are more likely to be alloimmunized. an overall immunization rate of - % is commonly admitted in the general population. depending on the unit selection policy and/or the study design, the immunization rate in scd patients varies from % to %, the highest figures being established when an abo/rh -only matching policy is implemented. in a meta-analysis of publications, the overall alloimmunization rates were around %. alloimmunization is thought to be enhanced by an inflammatory state, which is often present in scd patients. they are more prone to develop a new alloantibody. using a stochastic modeling of alloimmunization, they have a % increased risk of producing additional antibodies versus % in the general population. autoantibodies have been identified as a risk factor of alloimmunization. as a result, scd patients often have complex mixtures of allo and autoantibodies. rh antibodies and those considered as irregular natural antibodies are present in a significant proportion. another characteristic of the antibodies in scd patients is their evanescence; up to % of alloantibodies become undetectable within a few years of their initial development. relatedly, about a third of dhtrs are reported to happen in patients with no previous history of immunization. in addition, a third of patients will not develop an antibody after a dhtr. identifying patients at risk of developing a dhtr is key to managing them properly. alloimmunization is a serious risk of red blood cell transfusion in patients with sickle cell disease (scd) and can result in severe (delayed) haemolytic transfusion reactions, exacerbation of clinical symptoms and life-threatening hyperhaemolysis. once alloimmunized, the presence of alloantibodies in the patients' blood further complicates pretransfusion testing and hampers the selection of compatible blood products. numerous studies have shown that scd patients have a relatively high risk of alloimmunization as compared to the 'general' population. this is not only explained by the large number of transfusions given but also by the increased exposure to foreign antigens as a result of differences in the antigen make-up of the scd recipients and the blood donor population. other factors involved in the immune response such as age at first transfusion, inflammatory state, hla typing are under investigation and are starting to unravel. because blood transfusion is still one of the main treatment modalities for scd and some patients have a life-long transfusion dependency it is important to minimize the alloimmunization rate. theoretically, complete matching for all relevant blood group antigens would prevent alloimmunization. this however, is only possible when all donors are comprehensively. matching strategies should be developed to minimize alloimmunization while balancing patients' need and donor availability and is cost effective. to develop a (preventive) matching strategy some factors need to be established; ) which antibody specificities are clinically relevant ) which antigens are most immunogenic ) what is the availability of specific antigen typings in the donor population ) how should recipients (and donors) be typed, phenotypically and/or genotypically and to what extent. the latter is especially important in scd patients since they are of african descent and the prevalence of genetic variations in this population is relatively high. rhd and rhce variants are common and can remain undetected when serological typing is used but can be discovered with high resolution molecular typing. patients with partial rh phenotypes are at risk for alloimmunization. apart from special rh phenotypes in individuals from african descent, the fy(a-b-) phenotype related to the gata-box mutation in the fyb allele and the u-or u var phenotype resulting from genetic variations in the mns alleles are also common. several studies have shown that in scd patients antibodies directed against rhd, rhe, rhc and k are most frequently found when unmatched transfusions are given. preventive matching for these antigens has proven successful in reducing alloimmunisation. extended matching for all rh antigens fy(a), jk(a) and jk(b) can further decrease the alloimmunisation rate. currently, different countries have preventive matching strategies in place for this vulnerable patient group. as genotyping is more and more available and within reach, optimal antigen typing approaches for patients and donors, combining serology and genetics are being developed. in this lecture several aspects of antigen typing approaches and preventive matching strategies that will most benefit scd patients of will be discussed. artificial intelligence has become a buzzword that will appear about anywhere in the media. we can forget that ai, or the subfield in this computer science field machine learning, has been around for over years. improvements in computing power, abundance of data, progress in computer science, and the arrival of affordable cloud solutions have now brought it to our daily lives. also in health care news about ai has become omnipresent. and some landmark papers have come out on algorithms outperforming (teams of) physicians in the diagnosis of all kinds of skin disease, eye disease from retina scans, and detect cancer in ct scans. however, little of these solutions have actually shown up in our clinical practice yet. in anaesthesia, we worked with the first algorithm to come to anaesthesia practice; hypotension during surgery is associated strongly with poor outcome like myocardial ischemia, surgical complications, renal failure and even mortality. we worked on a machine-learning trained algorithm that predicts hypotensive events using the arterial blood pressure curve up to - min before the actual event. to get fda and ce approval, however, mere mathematic validation is required. this can be achieved on retrospective datasets. in reality, we need more before we can use these algorithms to support our decision-making; after internal (retrospective) and external (prospective but passive use) validation steps, clinical (i.e. rct validation is needed. moreover, we will need to assess the economic impact too. ultimately this tool has now reached clinical practice and is starting to help us go from reactive to more proactive hemodynamic management. like this, we have started to work on machine-learning tools to predict the incidence of specific types of patients coming into a&e and predicting infections after surgery. we will discuss our approach, essentials to start with machine learning, practical learnings. we will also discuss a first project design to use machine learning in managing bleeding patients to get the best therapy advice for blood product use like plasma, fibrinogen et cetera. how can we start using this tool in unison with our existing tools to improve science and clinical practice in our respective (bio)medical fields? thrombocytopenia is a very common hematological abnormality found in newborns, especially in preterm neonates. two subgroups can be distinguished: early thrombocytopenia, occurring within the first h of life, and late thrombocytopenia, occurring after the first h of life. early thrombocytopenia is associated with intrauterine growth restriction, whereas late thrombocytopenia is caused mainly by sepsis and necrotizing enterocolitis. platelet transfusions are the hallmark of the treatment of neonatal thrombocytopenia. most of these transfusions are prophylactic, which means they are given in the absence of bleeding. however, the efficacy of these transfusions in preventing bleeding has never been proven. in addition, risks of platelet transfusion seem to be more pronounced in preterm neonates. because of lack of data, platelet transfusion guidelines differ widely between countries. in a recent randomized controlled trial (planet- /matisse study) among preterm infants with severe thrombocytopenia, we found that those randomly assigned to receive platelet transfusions at a platelet-count threshold of /l had a significantly higher rate of death or major bleeding within days after randomization than those who received platelet transfusions at a platelet-count threshold of /l. this presentation summarizes the current understanding of etiology and management of neonatal thrombocytopenia. transfusion-associated circulatory overload (taco) is a severe transfusion adverse reaction that is associated with increased mortality and morbidity. the incidence of taco in adults varies from % to %, but is probably underdiagnosed and underreported. the incidence in the pediatric population is undetermined. taco usually occurs in patients who receive a large volume of blood product over a short period of time. it is more common in patients with known risk factors such as cardiovascular disease, renal failure, and older or younger age (> years or < years). hospitalised patients and intensive care patients are also more at risk. the typical presentation of taco is respiratory distress (dyspnea, tachypnea) occurring within h of a blood transfusion. associated signs and symptoms are hypoxia, hypertension, tachycardia, positive fluid balance, high central venous pressure, and acute or worsening pulmonary edema on chest x-ray. echocardiography and measurement of brain natriuretic peptide (bnp) or its n-terminal prohormone (nt-probnp) is helpful for diagnosis. several definition criteria have been proposed for taco, but none are adapted for children, particularly critically-ill children who are more at risk. this is probably the main reason why taco is even more underdiagnosed and underreported in the pediatric population. in a recent study, we compared the incidence of taco in a pediatric intensive care unit using the international society of blood transfusion (isbt) criteria, with two different ways of defining abnormal values: ) using normal pediatric values published in the nelson textbook of pediatrics; and ) using patients as their own controls and comparing pre-and post-transfusion values with either a % or % difference threshold. we monitored for taco up to h post-transfusion. a total of patients were included. taco incidence varied from . % to %, depending on the definition used. with such wide variability, we conclude that a more operational definition of taco is needed in pediatrics, particularly for critically-ill children. differential diagnosis from other dyspnea-associated transfusion adverse reactions (e.g. transfusion-associated lung injury, anaphylaxis) is important because treatment differs, as do guidelines to the blood bank. treatment for taco is similar to that of any other cardiogenic pulmonary edema: oxygen, diuresis, ventilatory support. prevention is possible by avoiding unnecessary transfusions, transfusing only the necessary amount of blood product, avoiding rapid transfusions, and using diuretics. background: the risk and importance of transfusion-transmitted hepatitis e virus (tt-hev) infections by contaminated blood is currently a controversial discussed topic in transfusion medicine. in particular, the infectious dose is a not finally determined quantity. the different countries have chosen different approaches to deal with this pathogen. one central question is the need of individual nat screening (id) versus minipool nat screening (mp) approaches to identify all relevant viremias in blood donors. aims: comparison and evaluation of the available screening strategies in relation to the infectious dose to minimize the risk of tt-hev infections. methods: we systematically reviewed the presently known cases of tt-hev infections and available routine nat-screening assays. furthermore, blood donation screening strategies for hev ehev in effect in the european union were compared. we also describe our own experiences of hev screening utilising an id-nat-based donor screening algorithm compared to mp-nat in pools of samples. from november to january , a total of , blood donations were screened for the presence of hev rna using a mp-nat (in house, realstar hev rt-pcr kit) and an id-nat (cobas platform). results: the review of the literature revealed a significant variation regarding the infectious dose causing hepatitis e. in the systematic case review, all components with a viral load (vl) greater than . e+ iu caused infection (definitive infectious dose (difd) . the lowest infectious dose resulting in tt-hev infection observed in general was . e+ iu (minimal infectious dose (mifd). the infectious dose of the different blood products is mainly influenced by the remaining plasma content. our data comparing the two different hev screening algorithms revealed eight hev rna positive donations using a mp-nat (incidence : , ) , whereas hev rna positive donations were identified by id-nat (incidence : ); all id-nat only positive donations had vl < iu/ml. summary/conclusions: taken into account the current knowledge on the required mifd, the difd, and the analytical sensitivities of the screening methods, we extrapolated the detection probability of hev-rna positive blood donors using different test strategies (nat assay, id vs. minipool with different pool sizes). we also considered the amount of plasma in the different blood products and calculated the infectious doses needed to be detected. only id testing would be sufficient to detect the minimum vl in the donor to avoid tt-hev infections based on the currently known mifd, but a highly sensitive mp-nat should be adequate as a routine screening assay to identify high viremic donors and avoid tt-hev infections based on the difd. we have also determined that the incidence of hev infection was approximately % higher if id-nat was used. however, vl were below iu/ml and will most likely not result in tt-hev infection taken into account the currently known mifd or difd. the clinical relevance of and need of identification of these low level hev positive donors still require further investigation. in the last years several pathogen inactivation (pi) technologies have been developed to be applied to blood components. technologies for inactivating pathogens in plasma and platelets are available in the european union, and some others are currently under development. the first pi technology introduced in the market was for plasma, and was based on the addition of methylene blue and the illumination with light (theraflex mb-plasma, macopharma and gr ıfols). for platelets and plasma two technologies are licensed, one is based on the addition of amotosalen and the illumination with ultraviolet light (uv) (intercept â , cerus) and the other one combines the addition of riboflavin (vitamin b ) and the illumination with uv light (mirasol â , terumo bct). currently another technology for platelet inactivation, based on the illumination with uvc light and strong agitation is under development (theraflex, macopharma). for red blood cells one technology based on the addition of one molecule (amustaline, cerus) is being developed. the mechanism of action, and the spectrum and level of inactivation of pathogens varies among the different technologies. in addition, the number of studies with clinically relevant endpoints and the number of patients included in the studies is not homogeneous. there is published evidence for most of them that show that the treated blood components are safe and efficacious for the patients although, for treated platelet concentrates some decrease in the posttransfusion recovery and survival of the transfused platelets occur, with differences between the different technologies. however, cumulative experience on the use in routine, for some of the technologies for almost years, support the concept of the safety and efficacy of the blood components treated with pathogen inactivation technologies without a significant increase in utilization. the use of pathogen inactivation for blood components is not widespread. differences in epidemiology between countries, infectious risk perception, concerns about potential adverse effects associated with its use and economical considerations might explain the differences observed in its implementation. the history of the p and p k antigens is complicated and sometimes confusing because of several changes to the nomenclature. the association between the antigens and their genetic home has raised many questions as well as the longstanding enigma regarding the molecular mechanism underlying the common p and p phenotypes. the system (isbt no. ) currently includes three different antigens, p , p k and nor. the p antigen was discovered already in by landsteiner and levine while p k and nor were described in and , respectively. as for the abo system, naturally-occurring antibodies of igm and/or igg classes can be formed against the missing p /p k carbohydrate structures. anti-p is usually a weak and cold-reactive antibody very rarely implicated in hemolytic transfusion reaction (htr) or hemolytic disease of the fetus and newborn (hdfn). however, some antibodies against p have been reported to react at °c, bind complement and cause both immediate and delayed htrs. the p k antibodies can cause htr and anti-nor is regarded as a polyagglutinin with unknown clinical significance. a higher frequency of miscarriage is seen in women with the rare phenotypes p and p k /p k . the rbc of the fetus as well as of the newborn express low amounts of p , p and p k antigens but the placenta shows high expression and is consequently a possible target of the antibodies and the cause of the miscarriages. the p k and p antigens have wide tissue distributions and can act as host receptors for various pathogens and toxins. furthermore, altered expression of p k antigen has been described in several cancer forms. a longstanding question has been why individuals with p phenotype not only lack p k and p expression but also p . recently it was clarified that the same a galtencoded galactosyltransferase synthesizes both the p , p k and nor antigens and in addition the p and p phenotypes was confirmed to be caused by transcriptional regulation. transcription factors bind selectively to the p allele in the '-regulatory region of a galt, which enhance transcription of the gene. it has been debated whether the p k and p antigens exist on glycoproteins in the human rbc membrane or if glycolipids are the only membrane components carrying these epitopes. a recent publication shows that the p antigen can be detected on human rbc glycoproteins and thus glycosphingolipids can no longer be considered as the sole carriers of the antigens. the blood group system which started out with one antigen, p , has now gained two more members namely p k and nor. step by step the biochemical and genetic basis underlying the antigens expressed in this system has been revealed but still many questions remain to be solved. neither gata nor klf represent a blood group system but mutations in the genes encoding these transcription factors (tfs) have been shown to result in simultaneous altered expression of blood group antigens in certain rare blood group phenotypes. in particular, mutations in the klf gene are responsible for the dominantly inherited in(lu) phenotype, commonly referred to as lu(a-b-) because of the gross reduction in lutheran antigens expression. red cells from in(lu) individuals, though, have also weakened expression of other blood group antigens, like the high-incidence antigen anwj, the antigens of the indian blood group system (cd ) and p , among others. since the first description of klf variants associated with the in(lu) phenotype, many other variants of this gene have been reported with an impact on blood group antigen expression and they are listed on the klf table of blood group alleles. other than klf , a mutated gata gene has also been found associated with the x-linked form of the lutheran-mod phenotype and has likewise been registered in the gata allele table. besides the effect of tf variants on blood group antigen expression, there are transcription factor-binding site polymorphisms in regulatory regions of blood group genes, which also have an impact on the expression of the encoded antigens in red cells. the first example of such type of polymorphisms was described in , when the disruption of a gata motif in the ackr gene promoter was found to abolish erythroid gene expression in fy(a-b-) individuals of african descent. the impact of mutations affecting gata binding sites has also been described in some abo subgroups, like the am and bm phenotypes. a regulatory element with gata binding sites in the first intron of the abo gene has been found to be altered in individuals with these phenotypes, either by deletion or by a point mutation disrupting the gata motif. recent findings have also revealed that xga expression on red cells is dependent on gata binding to a control element located . kb upstream of the xg gene. a single nucleotide polymorphism (snp) within this region was shown to correlate very well with the expected distribution of the xga negative phenotype in different populations. further work has demonstrated that this g>c snp disrupts a gata binding site and consequently abolishes erythrocyte xg expression. overall, these investigations have allowed to elucidate the underlying genetic basis for xga expression and have made xga genotyping possible. similar to xga, the p antigen has been known for a long time to be determined by the a galt gene but the molecular basis underlying the common p /p phenotypes has remained elusive till recently. several cis-regulatory snps had been identified in non-coding sequences around exon a, which showed a very good correlation with p antigen expression. interestingly, potential binding sites for several hematopoietic tfs were identified in the same region. finally, recent investigations have demonstrated the role of the runx tf in the expression of p antigen, by selective binding to a regulatory site present in p but not in p alleles. to summarize, variation in blood group antigen expression may result from mutations or polymorphisms in the regulatory region of blood group genes. recent reports have unravelled the molecular mechanisms underlying the expression of p and xga blood group antigens, which involves tf binding to allele-specific regulatory elements. similar mechanisms may also regulate antigen expression in other blood group systems. c- - clinical immunology, copenhagen university hospital, copenhagen, denmark since the discovery of cell-free fetal dna (cffdna) in pregnant women's blood, the development of noninvasive prenatal testing (nipt) has provided new diagnostic applications in prenatal care. in transfusion medicine and clinical immunology, cffdna is extracted from maternal plasma to predict fetal blood groups with the purpose of ) guiding targeted rh prophylaxis in non-immunized rhd negative women and ) assessing the risk of hemolytic disease of the fetus and newborn (hdfn) in immunized women. i will give an overview of noninvasive prenatal testing of fetal blood groups. based on the literature, i will summarize the current experience with noninvasive prenatal testing of fetal rhd and other blood groups. for rhd negative pregnant women, routine clinical testing is available in several countries world-wide to assess the risk of hdfn in d immunized women, and routine testing to guide rh prophylaxis is now implemented as nationwide service in - european countries. noninvasive prenatal testing for fetal rhd is highly accurate with sensitivities of . %, as reported from clinical programs. in general, the sensitivity is challenged be low quantities of cffdna, especially in early pregnancy. the specificity is challenged by the polymorphic rh blood group system, where careful attention is needed to navigate among the many rhd variants. rhd variants may complicate cffdna analysis and interpretation of results, especially in populations with mixed ethnicities. despite these challenges, fetal rhd testing is very feasible when implemented with careful attention to these issues. for blood groups that are determined by snps, such as kel or rhc, the main challenge has been interference from the maternal dna when analyzing the fetal dna which has resulted in low accuracy and lower sensitivity, when using qpcr. with the application of more novel techniques such as next generation sequencing and droplet digital pcr, accurate noninvasive prediction of these fetal blood groups has been demonstrated. the success of predicting fetal rhd and its successful clinical implementation into national programs should encourage wide-spread use of cell-free dna based analysis. future work on noninvasive prenatal testing of fetal blood groups determined by snps may consolidate the application for cell-free dna testing for such targets, including human platelet antigens. at isbt, the newly formed cfdna subgroup of the red cell immunogenetics and blood group terminology working party will work to facilitate clinical applications, implementation and evaluation of cell-free dna testing. blood banks in most of the nordic countries all share a vein-to-vein approach which in short means that the collection of blood, the preparation of blood components, testing/release and storing is served by a single actor. on top of that recipient and donor blood grouping, crossmatching, delivery, registration of transfusion and of any complications is usually handled in a single blood banking information system (bbis). this means that blood banks in the nordics are traditionally operated by a single vendor. the needs for process control in a single vendor bbis, the present solutions, unsolved challenges and untapped possibilities of streamlining processes have been scrutinized with the intention to describe separate processes and to acquire best of breed or best of suite it-systems. the aim for integrations, rather than building an integrated it-system, to support the need for a vein-to-vein process is a precondition in the nordic countries. with multiple it-systems supporting isolated processes, we intend to facilitate development in these and furthermore increase the flexibility in the whole process. we set out to reveal any existing knowledge in the literature on it vendor strategies for blood banks, but we didn't succeed in identifying any relevant literature. however, a systematic literature study on vendor strategies when choosing health it was based on the prisma method, and identified studies, but only was eligible for full text review and met the inclusion criteria. even this broader literature study reveals very little evidence. two studies find single vendor strategies poor and conclude "best of suite" solutions to be optimal. one study was not able to correlate vendor strategies to the investigated productivity, but concludes that best of suite and best of breed strategies requires larger organizational changes than a single vendor strategy. in summary, the existing research is contradictory. this paper adds basic knowledge for breaking down the process control of blood banking in smaller processes. this adds the possibility for identifying best of breed or best of suite vendors, instead of relying on single vendor it solutions. furthermore it is a call for more research in the field of vendor selection strategies which this study didn't succeed in identifying. d- - applying drones to supply blood to remote areas: rwanda's experience biomedical services, rwanda-ministry of health-national blood services, kigali, rwanda background: in rwanda, blood transfusion services started in . during the genocide against the tutsis almost all the socioeconomic fabric of rwanda was destroyed as well as its health infrastructure. the healthcare system was suffering in its aftermath, and there were health inequalities between urban and rural areas, including access to blood for transfusion. from , the government started to rebuild all courses of life including the health system and the blood service in particular. the national center for blood transfusion (ncbt) was then mandated to provide safe, effective and adequate blood and blood components to all patients in need. this was pivotal in achieving health related mdgs , and . today, rwanda has an ambitious vision to put all million citizens within minutes of any essential medical product. while every second matters in emergency management, the use of drones was the perfect solution to many of the last mile challenges that have been traditionally difficult to overcome. it is impossible to forecast accurately down to the need of a single patient. the government has provided an easy solution by centralizing supply and providing on-demand, emergency medical deliveries by drone. doctors are now empowered to provide the quality care with all the supplies on hand, patients can now be treated close to home, and we eliminate waste from potential overstocking when health workers know that they have a quick and reliable source of supply. description: in , the government of rwanda started to operate the world's first national drone delivery program for blood and other lifesaving medical products. these drones can carry two to six units of blood at a time and deliver in - minutes depending on a hospital's location. the average duration was between - hours round trip with the vehicle system, before the use of drones. drones currently deliver blood to health facilities throughout the country and are set to reach % of transfusing health facilities outside kigali by the end of the year. within the first year, healthcare workers saved an average of . hours per delivery and a total of , hours of lost time on road pick up they could instead dedicate to patient care. by march , over , deliveries have been made, with % of those being emergency deliveries. a total of more than , blood units have been delivered. in february , zipline obtained the highest rating from the health facilities being served in a performance evaluation conducted by the national center for blood transfusion. when a doctor or medical staffer needs blood, they place an order through the hemovigilance order portal. they are then sent a confirmation message saying a drone is on its way. the drone flies to the health facility at up to km/h. when it is within five minutes of the destination, the medical staffer receives a notification. the drone then drops the package, attached to a parachute, into a special drop zone. conclusion: supply is not a developing country problem, it is a global issue. rwanda was just the first one to recognize the potential of this technology and decided to do something about it first and fast, to ensure access to universal access to all blood products. d- - scottish national blood transfusion service, edinburgh, united kingdom supporting the provision of viable transfusion services in remote/rural areas is more than just a geographical challenge. limited qualified blood bank resource; small throughput volumes; increased regulation are only three of the additional factors combining to threaten safe and sustainable transfusion service delivery. inventory management and out of hours service provision were identified as essential areas where it was thought that technology, in the form of a remotely controlled blood fridge, could provide a key element of the overall solution. a radio frequency identification (rfid) fridge racking system was installed in a standard blood bank fridge and connected to the laboratory information management system (lims) common to both the remote and central blood bank. the central blood bank was enabled to test patient samples from the remote laboratory, identify components located in the remote fridge suitable for the patient and allow correct component issue, even when qualified staff were unavailable in the remote laboratory. testing has concluded that installation of remote fridge management can play a major role in helping to maintain a remote inventory permitting patient compatible components to be issued. by sustaining transfusion services in remote communities we can avoid transportation of patients who require transfusion support to locations miles from home. antibodies to hna- b, fcgriiib and hna- have been reported, too. neonatal alloimmune neutropenia results from maternal antibodies transferred transplacentally to the fetus and is caused by all known hna-antibody specificities, i.e. hna- a, - b, - c, - d, hna- , hna- a, - b, hna- a, - b and hna- a specificity. hna and hla antibodies can induce mild febrile transfusion reactions and trali. since the introduction of the male only plasma strategy, in many countries the trali incidence decreased but it is still one of the most common causes of severe transfusion reactions. especially hna- a antibody containing plasma from female donors is responsible for severe or even fatal reactions. but also hna- a, - b, hna- and hla class i and class ii antibodies were reported. the latter activate monocytes to secrete soluble factors that act on the primed neutrophils in the narrow lung capillaries. laboratory testing: laboratory work-up requires the knowledge of the patient's clinical condition and the methods that are appropriate to detect the relevant antibodies. the classical granulocyte agglutination test (gat) in combination with the granulocyte indirect immunofluorescence test (gift) can detect nearly all relevant antibodies. hna- , - , - , - and hla class i antibodies are clearly detectable in the gift while hna- antibodies strongly agglutinate neutrophils in the gat. the monoclonal antibody-specific immobilization of granulocyte antigens (maiga) test detects all hnaantibodies except for hna- with high glycoprotein specificity and sensitivity but is time consuming and requires highly skilled personnel. for trali diagnostics laboratory testing is completed by methods like the indirect lymphocyte immunofluorescence test (lift) or elisa for hla class i antibodies and hla class ii specific elisas. since several years fluorescent bead based assays (luminex) enable faster and more automated hna antibody detection but to date not all specificities, especially hna- , can be reliably detected so that still the classical gift and gat have to complete the methodological spectrum. serological typing today is mostly reduced to the determination of hna- in the gift because the molecular reason for the hna- -null phenotype is not completely understood. establishing only one pcr-asp reaction for the main cd * a>t polymorphism would comprise the risk to miss other molecular causes. however, for all other hna allelotyping by pcr methods is the first choice. summary/conclusions: granulocyte serology still today is widely based on a variety of manual methods and will be reserved to specialized laboratories as it requires experienced laboratory staff and profound knowledge of granulocyte immunobiology. d- - norwegian national unit of platelet immunology, laboratory medicine, university hospital of north norway, tromso, norway maternal alloantibodies against antigens on human platelets can cause severe thrombocytopenia and bleeding in fetus or newborn, identified as fetal/neonatal alloimmune thrombocytopenia (fnait) . although most cases the thrombocytopenia is selfresolving within the two first weeks of life, some infants present bleeding symptoms and thus require platelet transfusion. a set of laboratory analyses are required to confirm the fnait diagnosis. in addition to guiding compatible platelets to the affected newborn, the correct diagnosis will be valuable to assess the risk of fnait in subsequent pregnancies. in addition, platelet alloantibodies may also complicate platelet transfusions by immune-mediated platelet refractoriness, and require proper identification of the patient's antibody specificities prior to selection of donor platelets. the algorithm for laboratory investigations include both serological and molecular assays, and depend on the objective and timing: whether there is an urgent need for platelet transfusion, follow-up of a pregnancy with known risk, or to do full-scale laboratory testing to confirm diagnosis. molecular genotyping should include all hpa systems relevant for the local population (in caucasians hpa- , - , - , - and - ), preferably with optional extended panels for systems for low frequency populations due to immigration/mobility and for less frequently seen alloantibodies (hpa- , - to - are most commonly included). serological testing of antibody binding to platelets is often initially tested by flow cytometry analysis (direct test and/or cross-match). however, the detection of platelet-specific antibodies is often complicated by the presence of anti-hla class i antibodies and thus require sensitive platelet glycoprotein-specific assays. serological testing for platelet-specific antibodies includes as a minimum panels of antigens on gpiib/iiia, gpib/ix, gpia/iia and cd and preferably additional targets for populations with asian/african origin. several methods are available; i.e. bead-based assays and elisa based methods. however, most reference laboratories perform variants of the monoclonal antibody immobilization of platelet antigens assay (maipa), as reported by the th international platelet immunology workshop of isbt ( ) . the investigations also include measurement of the anti-hpa- a by quantitative maipa if present, as this is reported to potentially predict the severity of fnait. for pregnancies with known risk of fnait, there are methods available to perform non-invasive prenatal typing from maternal plasma. the most feasible and so far appropriate for routine testing is fetal hpa- typing with quantitative pcr or by melting curve analysis. other sophisticated, yet resource-demanding techniques have also recently been reported -importantly also for typing of other hpa-systems. d- - molecular basis of hna- expression justus liebig university, institute for clinical immunology and transfusion medicine, giessen, germany human neutrophil antigen (hna- ) is a neutrophil-specific antigen located on gpi-anchored glycoprotein cd (also known as nb ). hna- is absent on the neutrophil surface of - % of the healthy individuals that divided the population to hna- positive and hna- null individuals. exposure of hna- null individuals to hna- positive neutrophils during pregnancy, after transfusion or transplantation, induces immunization against hna- and consequently the production of iso-antibodies. the hna- iso-antibodies are involved in the mechanism of neonatal alloimmune neutropenia (nain), transfusion-related acute lung injury (trali) and graft failure following bone marrow transplantation. presence of cd on a neutrophil surface of hna- positive individuals follows a bimodal expression that categorizes the circulating neutrophils to hna- positive and negative subsets. the cd gene contains exons encoding a protein of amino acids. the lack of hna- (in hna- null individuals) is associated with the presence of a missense mutation, cd *c. a>t in exon of cd gene inducing a premature stop codon in codon . this mutation alone or in combination with cd *c. delg has been introduced as the main reason for the absence of cd in hna- null individuals. a pseudogene (cd p ) highly homologous to exons - of cd gene is located downstream of the cd gene. conversion of exon of cd p into cd gene is responsible for the generation of cd *c. a>t missense mutation. in addition, the heterozygosity or homozygosity of cd *c. a>t is accounted for regulation of hna- negative and positive neutrophils subpopulations. genotyping has revealed the hna- null individuals, heterozygous for cd *c. a>t mutation without cd *c. delg, indicating the presence of a complementary mechanism regulating cd expression. newly in hna- null individuals and individuals with atypical cd expression a cd * g>a polymorphism in combination with cd * a>t is described. altogether these data indicate a complex compound mechanism(s) for regulation of cd expression on the neutrophil surface. this presentation will summarize recent findings on cd expression and highlights the potential genotyping methods for genetic assessment cd expression of donors and patients. blood products ordered, transfusion start and end times, whether patients experienced a reaction to the transfusion as well as vitals measurements taken before and during the transfusion, including temperature, oxygen level, blood pressure and heart rate. for the validation process, transfusion nursing notes were sampled and reviewers assessed the accuracy of the information regarding ) blood product ordered, ) whether the patient experienced a reaction, and ) the start and end times of the transfusion. for each of these fields across all sampled notes, the claritynlp tool reproduced these data points with percent accuracy. in addition, the tool supplied transfusion end times for numerous structured records that were missing this key data point. summary/conclusions: claritynlp can very efficiently digest a large number of transfusion nursing notes simultaneously and also does an excellent job of extracting the main characteristics of a transfusion, which can be used in partnership with structured data to produce a more accurate and more complete picture of patient transfusions. immunohematology and genomics, new york blood center, new york, united states antibody-based typing, with a positive result reflected in agglutination of the red cells (rbcs), has served the profession for nearly a century enabling safe and effective transfusion therapy. the power of rbc typing by serologic methods lies in the availability of standardized antibody reagents which target many of the specificities of significance for transfusion, and the ability to directly detect antigen expression on the rbcs. hemagglutination has historically been relatively inexpensive, particularly for abo and rhd as the most important blood groups in most populations. serologic rbc typing is reliable, requires no sophisticated equipment, is generally straightforward to perform, and is fast requiring less than h to results. hence, antibody-based testing has been considered the "gold standard" for blood group typing. with the age of genomics, dna-based genotyping is increasingly being used as an alternative to antibody-based methods. most antigens are associated with single nucleotide changes (snps) in the respective genes. genotyping has been validated by comparison with antibody-based typing and has been shown to be highly correlated. the power of genotyping of rbcs lies in the ability to test for antigens for which there are no serologic reagents, and to type numerous antigens in a single assay using automated dna-arrays. this increases accuracy and weak antigen expression can be revealed. fresh rbc samples are not required for dna extraction, and there is no interference from transfused rbcs or igg bound to the patient's rbcs. dnabased typing is economical in that it provides much more information, but testing requires special equipment, training, and -h turn around. what then is the best approach to use? will serologic typing be replaced by dnabased typing? indeed, genotyping will increasingly be used in the practice of transfusion medicine, especially with the growth of whole genome sequencing (wgs). however, because serologic typing for abo and rhd is fast and accurate and often relied on for sample identification, genotyping will not be the sole means for routine typing. genomic sequencing approaches will certainly reveal unrecognized changes and genetic variability in rbc membrane proteins, but not all variation will be immunogenic. a genetic polymorphism must be associated with antibody production to be considered a blood group antigen. the importance of an antibody, and antibody reactivity, then will continue to be the central defining principal in transfusion. as two sides of a coin, both are key to safe and effective transfusion therapy. since the mid- s, research in the molecular basis of structural and functional aspects of proteins carrying and producing the antigens has led to an upgraded and modern understanding of blood group variation. most commonly, single nucleotide polymorphism (snp) based basic molecular typing techniques were utilized to test new findings on a smaller subset of samples, and resulted in concordant sero-and genotyping results in general. however, quite commonly a small number of all samples delivered discrepant results, triggering consecutive rounds of analysis and resolution, finally resulting in a better knowledge with respect to the underlying blood group variation. such rounds of repetitions represented the synergistic incremental process of learning, learning for serologists and molecular biologists. inheritance of public, presence of high frequency, or low frequency, or partial antigens and notice of weakly expressed, or almost undetectable antigens marked the path of incremental learning and may best be exemplified by discoveries within the blood group systems abo, rhd and kell. naming for pheno-and genotypes coevolved alongside the permanent discovery of new antigens. at present, antigens and their antithetic counterparts (if tested and if existent), are more commonly reported independently, as exemplarily shown for the following kell phenotype consisting of three antithetic antigen-couples: kk, kp (a+b+), js(a+b+). alternatively, the same phenotype could be stated as: kel:- , , , , ( ), , . genotypes, on the other hand, rather mirror the actual biological background, e.g. display the two parental alleles (or "haplotypes") present in an individuals' sample. genotype of the above mentioned example would read: kel* . / . (italicized). in an idealized diagnostic environment and for most blood group systems encoded by proteins, every single blood group allele would be defined by its full genomic sequence, derived from one parental chromosome (including "some" 'and '-untranslated regions). thereby, every such "ideal allele" would fully declare presence or absence of all its public, low-and high-frequency antigens and possess its "ideal name". by trend, biallelic snps and their immediate relation to antithetic antigen couples might have distracted from the originally intended meaning of "blood group alleles", more recently. finally, genotypes only dependent on (ideal) allele names, and considering mendelian inheritance patterns (dominant, recessive), would allow for fully comprehensive phenotype predictions. more recently, blood group serology, e.g. the "second side of the coin", seems to gain momentum. since the advent of whole genome sequencing and access to many more than human genomes, it seems that dozens of new blood group alleles are discovered, almost on a daily basis. beside the challenge of naming this multitude of alleles, respective discoveries are frequently made in samples lacking any phenotypic blood group pre-values. clear procedures will be needed to address naming and analyzing the phenotypes resulting from previously unknown alleles. as a consequence, questions asked years ago have changed: today, molecular biologists looking at hundreds of newly discovered blood group alleles find themselves not being asked by serologists any more: "can you confirm my serology?", but instead, pose their question to the experts for the blood group phenotype: "can you confirm my genotype?" a-s - background: the screening of blood donors and returning travelers from active transmission areas have highlighted the importance of diagnosis of acute arboviral infections. in the context of co-infections and similar clinical signs in endemic zones, the differential diagnosis of arboviruses is essential to discriminate the causative agent. the detection of viral nucleic acids in serum or plasma provides a definitive diagnosis, however, in most instances, viremia is transient within less than two weeks after the onset of clinical illness. in addition, the cross reactivity due to the high degree of structural and sequence homology between zikv and other flaviviruses is a significant concern. the combination of molecular (identification of viral genomes) and immunological assays (detection of the immune response) is a key challenge to follow the natural history of these infections and to improve the patient management and the epidemiological surveillance. aims: in this context, we have developed an innovative platform based on agglutination of superparamagnetic nanoparticles (npmag) covalently grafted either with nucleic or proteic probes to face the continuing emergence of arboviruses. methods: dengue (denv) and zika (zikv) viruses are selected as models in this study. a pan-flavivirus rt-pcr is used for the molecular assay to amplify the viral genomes. then, biotinylated viral amplicons are captured specifically on complementary original polythiolated probes coated on npmag. for the immunological assay, npmag are grafted with viral ns proteins to capture anti-denv or anti-zikv antibodies potentially present in the plasma samples. both tests are performed in disposable cuvettes in a homogeneous format. a magnetic field generated by an electromagnet is applied to the reaction medium to align the npmag into chains to enhance the capture of the targets between two npmag. aggregates formed are detected when the field is turned off. the optical density is measured in real-time at nm during several cycles of magnetization / relaxation. results: in this study, molecular analytical performances were evaluated on human samples from blood donors with no history of infections as negative controls, on viral standards and on clinical samples. using viral references standards, we have observed sensitivities of - tcid /ml for zikv and denv (serotypes / / / ) after a detection phase of around min. the first results obtained on zikv (+) clinical samples previously tested by commercial real-time pcr (ct < , altona) showed an % correlation between the two detection methods. no false positive results or cross reactions were observed. concerning immunological assays, commercial human plasma from donors tested positive for denv or zikv antibodies were detected positive with our innovative approach in less than min (sampling + detection) instead of h with classical elisas. further assays on clinical samples are planned to confirm these preliminary results. summary/conclusions: this innovative strategy combining molecular and immunoassays on the same analytical platform offers new opportunities for rapid blood testing to improve the surveillance and the prevention of arboviral infections. background: zika virus (zikv) caused a dramatic epidemic in puerto rico (pr) during , with up to~ % of blood donors reactive for zikv rna in id-nat testing at the peak in june . aims: perform a serosurvey for anti-zikv igg using six panels of donor specimens each collected in march , at the beginning, peak and end of the epidemic, and from march and april . methods: we employed a commercially available zikv igg elisa antibody (ab) assay based on the zikv ns antigen from bio-techne to characterize zikv seroprevalence in the cross-sectional sample sets (anonymized with selected demographic information). results: pr donor samples collected in april were initially evaluated using the manufacturer supplied cut-off to confirm that the zikv ab results were largely negative ( positive, equivocal) despite the high dengue virus seroprevalence (> %) in pr that could potentially lead to false positive zikv ab results. we then used this dataset, together with known positives collected - months postdetection from zikv nat yield donors, to set a population-specific cut-off based on receiver operating characteristic (roc) curve analysis. this cut-off yielded sensitivity and specificity values of > %, and an area under the curve (auc) of . , demonstrating a highly accurate assay. we used this new cut-off to calculate final rates of seroreactivity in the additional sample sets ( samples) and estimate seasonal incidence. rates of reactivity, together with mean net od for only the reactives (shown in parentheses), were calculated for each sample set: background: sex hormone intake in blood donors occurs in three demographic groups: premenopausal women who take contraceptive drugs (progestins with or without estrogens), postmenopausal women who receive estrogen replacement therapies that may be combined with progestins, and testosterone therapies in men. we hypothesized that sex hormone therapies may modulate the quality of red blood cell (rbc) products via alterations of rbc function and predisposition to hemolysis during cold storage. aims: the objectives of this study were to evaluate the association between sex hormone intake and rbc measurements of hemolysis, and to examine possible mechanisms by which sex hormones interact with rbcs. methods: self-reported sex hormone intake and menstrual status were evaluated in , female blood donors from the national heart, lung and blood institute's rbc-omics study. the associations between hormone intake and donor scores of spontaneous storage, osmotic, or oxidative hemolysis were determined in all women and by menstrual state. the interactions between sex hormones and rbcs were determined by sex hormone (progesterone, b-estradiol, or testosterone) potency to inhibit calcium influx or hemolysis during incubations or cold storage. the calcium fluorophore, fluo- am, was used to define rbc calcium influx in response to treatments with sex hormones or drugs that modulate transient receptor potential cation (trpc) channel activity including hyp (a selective trpc activator). results: sex hormone intake by menstrual status was higher in premenopausal women ( . %) than in postmenopausal women ( . %). female hormone intake was significantly (all p < . ) associated with reduced storage hemolysis in all females ( . ae . % versus . ae . % in controls), enhanced susceptibility to oxidative hemolysis ( . ae . % versus . ae . % in controls), and reduced osmotic hemolysis in postmenopausal women ( . ae . % versus . ae . % in controls). in vitro, supraphysiological levels of progesterone ( or lmol/l), but not b-estradiol or testosterone, inhibited spontaneous or hyp -induced calcium influx into rbcs, and were associated with lower spontaneous hemolysis after day cold storage ( . ae . % versus . ae . %, progesterone lmol/l versus solvent control (dimethyl sulfoxide, . %), p < . ). co-incubations ( . h, °c) of rbcs in the presence of progesterone and a trpc activator (hyp , lmol/l) suggested that progesterone protected against hyp -induced hemolysis ( . ae . % and . ae . % versus . ae . %; hyp + progesterone at or lmol/l versus hyp alone, p < . by one-way anova). summary/conclusions: this study revealed that sex hormone intake in blood donors is capable of modulating rbc predisposition to hemolysis and led us to propose new mechanistic pathways by which progesterone regulates calcium influx and hemolysis in human rbcs. pre-and postmenopausal women respond differently to hormone intake and its effects on rbc responses to osmotic or oxidative stress. progesterone modulates calcium influx into rbcs via a mechanism that may involve interactions with membrane trpc channels, activation of which is associated with pre-hemolytic events such as senescence and eryptosis. a-s - international cooperation, swiss red cross, wabern, switzerland background: red cross and red crescent societies were playing an important role in setting up blood transfusion establishments in many low resource countries. by the mid- s, the red cross was active in the national blood programs in approximately % of countriesmostly in blood donor recruitment and education. today, major organizational developments in blood transfusion services were made in high income settings, where nearly % of all worldwide donations take place (home to only % of the population). who data shows that the median annual blood donation rate in high-income countries is . % of the population compared to . % in low-income countries. the factors for this low turnout are multilayered, but it is well-known that most resource poor settings suffer from a low rate of regular donors and challenges to set-up and financially sustain a national blood donor program. the red cross and red crescent (rc) societies assume a key role by reaching and retaining donors from the communities and contribute significantly to better safety and availability of blood. partnerships and international collaboration, such as the swiss red cross (src) program, are aiming to strengthen national structures to improve blood safety and to face today's epidemiological, demographical, and technological challenges. aims: the present work aims to review the role, the mandate and the impact of rc societies in improving blood safety through systematic "voluntary non-remunerated regular blood donor" (vnrbd) programming and international partnerships. methods: data and evidence is drawn from the src international cooperation projects over the last years, more specifically partnering with three rc societies, and the data from the global advisory panel (gap) of the ifrc including their global mapping. results: the promotion of vnrbd has been a specific objective in all src supported programs. through the engagement of the rc society, the training of volunteers and partnering with the health authorities, the projects significantly increased the blood donor rate by recruiting and retaining donors from the communities. for example, the rc societies increased total donations by % in lebanon; vnrbds by % annually in kirgizstan, and from practically zero to ' in south sudan. the importance of rc societies was also underlined in the published global mapping of gap, which showed that ( %) of them provide level a (full blood service), ( %) are level b (systematic blood donor recruitment) and ( %) are level c (vnrbd blood promotion) blood services. gap has also commenced a new three year vnrbd support program aimed at establishing tools and materials for national societies. summary/conclusions: the red cross / red crescent movement has a unique mandate and position in improving global blood safety at all levels; with its huge network of volunteers, even blood donors in remote communities can be reached and retained. rc societies in low resource settings with a level b or level c role should further capitalize on partnerships with local and international actors to leverage technical assistance and funding for their activities. background: it is essential to motivate and encourage the public to donate blood and be eager to help saving lives, in order to maintain safe and adequate national blood supply. aims: "technical assistance for recruitment of future blood donors (europeaid/ /d/ser/tr)" project aimed to avoid problems in supplying the safest blood to contribute to the improvement of public health by (i) increasing the knowledge of primary and secondary school students regarding blood donation, (ii) creating sensitivity in school principals and teachers regarding voluntary non-remunerated blood donation (vnrd), (iii) motivating family members of the students for blood donation and (iv) creating public awareness through media. methods: an effective coordination is established between ministry of health (moh), ministry of national education (mone) and turkish red crescent (trc). the existing curricula and textbooks of primary and secondary schools were reviewed and revised, and corresponding materials on the importance of blood donation were created. the human resources capacity of moh, mone and trc to support raising awareness on blood donation were developed. to raise public awareness on blood donation nationwide, education and recruitment campaigns on were organized in pilot schools. additionally, media and public relation campaigns on blood donation were organized throughout the country. results: ( ) existing curricula and textbooks relevant to promoting blood donation were reviewed, revised and reported to the board of education of mone. ( ) corresponding educational materials for students and teachers were developed and distributed. ( ) blood donation clubs were established in pilot schools. ( ) trainings were conducted for personnel of moh and trc on blood donation regarding their responsibilities. ( ) cascade trainings were conducted for personnel of transfusion centers and school principals in provinces. ( ) information seminars were delivered to . students and . teachers and family members of students during school campaigns. ( ) four animation films on blood donation were produced and broadcasted on the national tv channel (trt). ( ) three different computer games targeting different age groups were developed and uploaded to the web portal of the project and distributed to the pilot schools. ( ) media spots were produced and broadcasted . times in different tv and radio channels. ( ) billboard posters and brochures were prepared and distributed to provinces for raising public awareness. ( ) advertisements about the project and the importance of vnrd were displayed times on national and local newspapers, . times on online news, and broadcasted on national tv channels. ( ) during the campaigns, . units of whole blood were collected in pilot schools. ( ) visibility kits to recruit future blood donors are prepared and distributed throughout the project activities. ( ) awareness and knowledge level of students and their teachers/parents on the importance of blood donation are increased to . % and . % respectively, assessed through pretest and posttest. voluntary non-remunerated donation rate of national demand increased from . % to . in two years. summary/conclusions: training and campaign programmes successfully increased the knowledge on blood donation. to achieve national self-sufficient safe blood supply, efforts for recruitment should be continued. background: despite % of pakistan's population being under years, only % of blood supplies come from voluntary donors while remaining blood is collected from 'family replacement donors'. in pakistan the system has outsourced the mobilization of blood donors to the patient families. as a result many people reach out to their networks including on facebook to locate blood donors. there are thousands of posts each month in pakistan seeking blood donors on facebook. to facilitate needy families, the global social media giant facebook launched a special blood donation feature for pakistan in collaboration with sbtp, pakistan. the feature makes it easier for people to sign up to become blood donors and helps connect these voluntary donors with people and organizations in need of blood. similar features have been launched by facebook in india, bangladesh and brazil to address the problem of blood shortages in those countries. however, among these four countries pakistan has unique position because of the existence of a national counterpart, sbtp which can facilitate facebook in promoting its feature and provide the feedback on the impact of this innovative effort for continuous improvement of the feature. aims: to promote voluntary blood donations and blood safety in pakistan through facebook. methods: the facebook and sbtp teams launched a pilot to study the impact and effectiveness of the facebook blood donation feature as a tool of community engagement. a six months plan has been chalked out to measure the impact of this tool in five selected blood centres. a checklist called "p checklist" was shared with these blood centres to fulfill some basic requirements for an official blood bank page including a display picture, cover photo, contact information, directions, etc. regular skype meetings are held between the teams of sbtp, facebook (san francisco and singapore) and the blood centres to monitor the progress of the pilot and generate feedback. results: the facebook blood donation feature has recorded remarkable success with over one million signups within few months in pakistan. the blood centres participating in the pakistan study have experienced enhancement in the voluntary blood donations trend with - walk-in donors and an average of more than telephonic queries regarding voluntary blood donation per month in each center. the trend is gradually surging as the feature is being refined on the basis of feedback received. the pilot will end in june . the statistics generated since january are very encouraging and underscore the importance of social media in reaching out to the untapped potential blood donors. the study will be used to plan an effective nationwide strategy to increase donor mobilization, recruitment and retention. background: in our region, an increasing number of patients of african or asian origin with sickle cell disease (scd) or transfusion dependent thalassemia (tdt) require red blood cell (rbc) transfusions, and many have rbc alloantibodies. selecting optimally matched rbc units for these patients is essential for preventing not only acute hemolysis but also further alloimmunisation. beside antigen-matching for abo, rh d, c, c, e, e and k, patients with scd and tdt should ideally receive rbc units matched also for m, s, s, fya, fyb, jka and jkb (extended phenotype). this is the policy at our center, which currently provides rbc products to patients with hemoglobinopathies. because the vast majority of our blood donors are caucasians, the selection of matched rbc units for patients of different ethnic origin can be difficult. therefore, expanding the number of available african and asian blood donors is becoming increasingly necessary. aims: hereby the recruitment strategy of non-caucasian blood donors introduced at our center is described and the results obtained during six years are reported. methods: since . . , whenever a first-time blood donor of non-caucasian origin is registered, an alert is entered in the donor file to trigger the determination of the extended rbc phenotype along with routine testing. rbc antigen determination is performed in our laboratory with serologic methods. in selected cases (i.e. suspected rhd or rhce variant), samples are sent for molecular analysis (ssp pcr). rare rbc phenotypes relative to ethnicity are, among others, fy(a-b-), s-s-, lu(b-) and those with uncommon rh phenotypes. if a rare rbc phenotype is detected, a coded comment is entered in the donor data and the donor is listed in the national rare donor file. results: from . . until . . , an extended determination of rbc antigens was performed in subjects presenting for blood donation. twenty-nine rare donors ( %) were identified and included in the rare donor file: fy(a-b-), lu (a-b-), lu(b-), fy(a-b-) and s-, ccddee (r'r'). overall, these donors provided rbc units (range . to date, all donors are still active and are reserved for dedicated donations. the internal price of rbc antigen testing per donor is approximately . -chf, resulting in a total financial effort of around , .-chf in the time since the project was started. summary/conclusions: in our experience, a "passive" recruitment of non-caucasian blood donors based on ethnicity has an overall low efficiency from a logistic and financial point of view. moreover, african and asian blood donors may require investigations for hemoglobin variants and serology for malaria in addition to routine testing. nevertheless, a targeted determination of extended rbc antigen phenotype does allow the identification of persons with rare phenotypes. currently, measures for the active recruitment of potentially rare blood donors are being implemented at our center. after a pilot phase, a project for a nationwide recruitment strategy will be elaborated. a further goal is to build a national registry of patients with hemoglobinopathies requiring transfusions. blood transfusion is an essential treatment. transfusion safety consists of several components. although all are important, ion richer countries the order of priority is typically: .) avoidance of transfusion transmittable infections; .) quality of the blood product with a strong focus on component therapy; .) prevention of severe transfusion reactions; .) avoidance of clerical errors; .) sufficient availability of blood. the keynote of this lecture will be that the order of priorities on transfusion safety should probably be different in resource limited environments. .) sufficient availability of blood and proper utilisation; .) avoidance of transfusion transmittable infections; .) avoidance of clerical errors; .) prevention of severe transfusion reactions; .) quality of the blood product. most important, in regions with limited resources patients suffer from under-transfusion because not enough blood is available. all efforts should be made to reduce wastage of the available blood either by inappropriate storage, handling, or nonindicated transfusions. in addition, prevalence and number of pathogens transmittable by transfusion is much higher than in the richer parts of the world. this is aggravated by the fact that rejection of blood donors based on their history is problematic when the blood bank is empty. the aim to develop centralized national blood services with few sites manufacturing cost effective (low personnel costs) high-quality blood products, which are distributed to regional hospitals is not matching the reality of infrastructure, governmental support, and functionality. in healthcare systems with limited resources usually available personnel (hands) is not a problem, while reagents, equipment and even electricity are precious resources. the lecture will propose to focus on staff training and education, establishing local hospital-based transfusion services, which provide the blood products for the region, based on donor recruitment campaigns adjusted to the available technology, local culture, including replacement donor programs, with retention of safe donors as highest priority. fractionation of blood into components had been standard in transfusion medicine, but recently whole blood has experienced revival for patients with acute blood loss. given main transfusion indications such as postpartum hemorrhage, or severe trauma, in regions with limited infrastructure, whole blood might be the more appropriate product. most patients requiring transfusion in these regions are younger and volume overload by whole blood is not a major issue. in addition, frequent electricity failures do not allow prolonged storage of plasma at - °c (this is therefore mostly wasted), although this issue can be overcome by solar powered freezers. ideally whole blood should be pathogen inactivated for which two methods are currently available. to reduce frequencies of acute hemolytic transfusion reactions again education and training to minimize clerical errors in the transfusion process are most important. extended testing for other rhesus antigens and k beside abo and rh-d in transfusion dependent hemoglobinopathy patients may help to reduce delayed hemolytic transfusion reactions. currently a leukodepleted pathogen-inactivated whole blood product might mostly serve the needs for blood transfusion in regions with limited infrastructure . the developed world should invest research efforts to develop such a product available at affordable costs. background: in modern transfusion medicine, serological investigations for blood cell antigens are complemented by genotyping arrays and pcr assays. whilst these platforms are informative in the majority of reference investigations, they are limited in their ability to define nucleotide variants associated with rare antigens and unable to detect novel variants potentially affecting antigenicity. next-generation sequencing is increasingly being employed in reference settings, providing information that cannot be obtained through these methods. whole genome and whole exome sequencing have been successfully employed in many investigations of novel and rare antigens, however concerns remain regarding the collection of genomic data unrelated to reference investigations, and reporting clinically significant incidental findings. these concerns can be addressed through the use of targeted sequencing panels. we report on the design, testing and efficacy of a panel providing a comprehensive genotyping profile for red cell, platelet and neutrophil antigens in a single test. aims: design a customised targeted exome sequencing panel for red cell, platelet and neutrophil antigen genes, and benchmark the efficacy against a commercial medical sequencing panel (illumina trusight one -tso). -test the panel and in-house genotype prediction script on sequence outputs from samples with known red cell, platelet and neutrophil genotypes and phenotypes and determine whether predictions are concordant. methods: the panel was designed with probes covering exons of genes associated with red cell, platelet and neutrophil antigens. using illumina nextera rapid capture technology, samples were tested over five sequencing runs, on standard and micro chemistries, to determine optimal sample plexity per standard run, and the efficacy of smaller flow cells for lower throughput applications. an in-house python script was used to predict star-allele genotypes based on variants listed in isbt and embl databases. these predictions were compared to results from serology, snp array and previous tso data. results: coverage consistently averaged > , with % of target at a quality of q . optimal sample plexity for a standard run was determined to be samples, allowing for sufficient coverage of all clinically significant variants. for red cell samples with previous typing data (excluding rh structural variants), the script correctly predicted . % of snp based red cell genotypes. script predictions were % concordant for platelet genotypes, and four of five neutrophil antigen genotypes. hna genotypes defined by cd could not be reliably determined. the increased target coverage of the panel allowed for detection of a clinically significant heterozygous variant in scianna system, previously undetected by the tso panel due to extremely low coverage. additionally, a variant defining a potentially novel null allele was detected in the p pk system. summary/conclusions: the panel demonstrates considerably higher coverage, quality and throughput compared to the tso and allows for detection of variants previously overlooked due to low sequencing coverage. up to samples can be reliably sequenced in a single run. our script correctly predicts over % of snp based alleles; however, rh structural variants require further manual analysis. background: to ensure the safety of a transfusion it is critical to identify the blood type of both donor and recipient. serological methods for typing abo, rh and kel use monoclonal antibodies, however, typing reagents for rare blood groups are expensive, unavailable or unreliable. dna-based identification of human blood groups has been used to overcome these limitations and its application has reduced rates of alloimmunisation in chronically transfused patients. however, to date, the cost per sample has prevented the universal application of dna-based donor typing aims: to achieve universal adoption of dna based donor typing, the blood transfusion genomics consortium (bgc) set out to develop an affordable dna based platform, capable of typing all red cell antigens, hla class i and ii and human platelet antigens. methods: the uk biobank axiom array, previously used to type , uk citizens, was redesigned for donor typing using three approaches: i) mining transfusion medicine knowledge, e.g. isbt allele tables; ii) inclusion of loci associated with donor health; iii) extraction of all coding variants in relevant genes with a frequency > : , identified in large-scale sequencing data. samples from nhsbt and sanquin blood donors (n = , ) were used for performance assessment. red cell and platelet antigens for each donor were inferred from genotypes using the bloodtyper algorithm and concordance with clinical serological typing results assessed. results: concordance between genotypic and serological typing results was . % for , comparisons; of the discrepancies were serologically negative and genotypically positive for a given antigen (k/k, fy[a/b], lu[a/b]). in all cases dna variants known to modify or weaken antigen expression were detected, displaying the power of genotyping to detect variant 'weak-antigen' expression. across antigens for which serology was available, genotyping provided a . -fold increase in the number of typing results available per donor ( . vs . ). furthermore, genotyping provided data on an additional clinically relevant antigens, allowing identification of antigen-negative donors and blood group identification for which antibodies are not commercially available. the power of a genotyped panel of donors to support patient management was demonstrated by a retrospective analysis of clinical cases referred to nhsbt. from , patient referrals with > alloantibodies between and , unique alloantibody profiles were identified. we found that there was a . -fold greater likelihood of finding o negative compatible donors for these patients when using genotyping data from the , nhsbt donors. importantly, the number of alloantibody combinations for which no compatible antigen-negative donor could be identified fell from to , representing an additional patients that could be provided with directly compatible blood using the same donors. summary/conclusions: through the bgc efforts an affordable fully automated genotyping platform, including the processes for quality assurance and data analysis, has been developed. furthermore, we have demonstrated the real-world benefits more extensive donor characterisation can provide when selecting blood for patients with multiple antibodies. the results of this international collaboration provide opportunities to introduce fully-automated genotype-based donor typing in a safe and cost-efficient manner in blood supply organisations. c-s - biobank performs whole-genome sequencing (wgs) from individuals nation-wide. these data are suitable for allele frequency analysis to demonstrate gene expression and genetic profile in our population, also to estimate the significance of each antigen in transfusion practice. aims: we aim to provide and verify population-based blood group antigen profile using wgs and dna samples from taiwan biobank. methods: a near wgs and demographic data were analyzed. annotations of blood group antigen were performed according to variants from isbt allele tables, including transcription factors; variants for the lewis system were obtained from previous studies. annotations of blood group variants were verified by dna samples with targeted sequencing on illumina miseq, and specific variants were verified by dna samples with the commercial genotyping kit or sanger sequencing. allele frequencies from wgs analysis were compared with population serology data using two-proportion z test. results: population-wide blood group antigens were analyzed, revealed in-depth antigen expression profiles in all systems (except ch/rg). the antigen frequencies from wgs were similar compared with published serology data, except for the antigens and possible explanations listed as follow, ) m, n: insufficient sequencing reads, ) c, c: identical rhce exon with rhd exon for c allele, ) mur: insufficient read length/depth for gypa/gypb hybridization calling and individuals from high prevalence of mur antigen in aboriginal tribes were not enrolled. blood group antigen predictions and variants from wgs were accord to dna verification. furthermore, systems shown no genetic variations, predicting uniform antigen expression in our population, and we can manage transfusion with minimum concerns for antigen mismatch in these systems. moreover, we found weak and null alleles in our population for blood group systems that we had previously no knowledge of, such as lan, jr, and vel. these variants were helped to identify a patient with anti-jr a carrying homozygous jr a null alleles. summary/conclusions: taiwan biobank wgs is suitable for full blood group antigen profile determination with few adjustments required for specific antigens. the population antigen allele frequency provides valuable insight to antigen significance in transfusion practice, matching strategy for our patients, and estimation of the likelihood to obtain for specific antigen negative blood from mass population. also, the genetic variants revealed in this study can help us to locate rare donors, and to integrate variations into routine donor blood group screening to provide suitable blood at a low cost efficiently. background: providing adequate amounts of safe, appropriately matched blood to meet the demands of an expanding and aging patient population presents a challenging global problem. for these reasons, sustainable in vitro sources of red cells may offer a desirable alternative to reliance on donor blood. the first stable immortalized early adult erythroblast cell line, bel-a , has been shown to differentiate efficiently into mature, functional reticulocytes (trakarnsanga et al., nat commun. : , ) and consequently could provide a readily available tool for diagnostic use and proof of principle for future therapeutic use. aims: at ibgrl, next generation whole exome sequencing (wes) has been used previously to accurately predict blood group phenotype in a number of blood group systems, including abo, rh and mns (tilley & thornton, transfusion medicine (suppl. ) : , ). here we have used it to analyse and document bel-a blood group-related genotypes and predict blood group phenotypes. additional genes involved in cell-growth and enucleation were also analysed in order to further elucidate the characteristics of the bel-a cell-line. methods: bel-a cells (day ) were cultured in expansion medium and genomic dna (gdna) was isolated from cells on day . for wes, gdna libraries were prepared using nextera â rapid capture exome enrichment and sequenced on illumina â miseq. sequence alignments for genes encoding all known blood group systems and further genes encoding transcription factors and cell enucleation-associated proteins were visualised using integrative genomics viewer, whilst illumina â variant studio was used to identify observed mutations. mutations in coding regions were used to determine bel-a genotype and predicted phenotype. results: good coverage of most of the selected genes was achieved. alignment of homologous blood group genes including rhd/rhce, gypa/gypb and c a/c b was problematic and additional analysis of coverage of these genes was required for accurate interpretation. despite a number of polymorphisms observed across the tested genes, bel-a did not express any novel or rare blood group antigens. genotyping results predicted a common antigenic profile, in agreement with previous serological and genotyping results where available. although a number of missense single nucleotide variations were detected in analysed genes, including cr , cdan and tmx , these were common polymorphic variants and unlikely to be of any functional significance. summary/conclusions: wes was used to determine bel-a genotype in relation to blood group genes and selected genes encoding transcription factors and proteins associated with cell enucleation. wes allowed accurate prediction of blood group phenotypes, showing full concordance with available serological data (trakarnsanga et al, ) . a small number of mutations were identified which are of unknown significance and require further work to determine any potential phenotypic effects. this complete record of the bel-a blood group-related exome will enable reliable gene editing strategies for future diagnostic and therapeutic purposes. additionally, knowledge of the full cell line exome will allow analysis of any emerging genes of interest and provide better insight into the mechanisms of erythroid differentiation and enucleation. background: emerging evidence, especially in neonates, has shown potential harm associated with liberal platelet transfusion strategies. very little evidence exists regarding optimal platelet transfusion thresholds in critically ill children. randomized controlled trials may be difficult due to lack of equipoise from providers. if regional variation in practice exists, comparative effectiveness studies may be an alternative approach. aims: to describe regional variation in platelet transfusion practices in critically ill children. methods: secondary analysis of a prospective, observational study. subjects were grouped according to region (north america, europe, middle east, asia and oceania) and nation. transfusions were analyzed as prophylactic (given to prevent bleeding) or therapeutic (given to treat bleeding). the primary outcome was the total platelet count (tpc) prior to transfusion. sub-groups analyses were performed in children with an underlying oncologic diagnosis and those supported by extracorporeal life support (ecls). the dosing and processing of the platelet transfusions were analyzed as secondary outcomes. results: five hundred and forty-nine children from countries were enrolled ( % in north america, % in europe, % in oceania, % in asia, and % in the middle east). overall, the median (iqr) tpc prior to prophylactic transfusions (n = ) differed significantly on a regional basis (p = . ) and ranged from ( - ) x cells/l in the middle east to ( - ) x cells/l in asia. the median tpc prior to prophylactic transfusions did not significantly differ between countries (p = . ), nor did the tpc prior to therapeutic transfusions (n = ) differ on either a regional (p = . ) or national (p = . ) basis. for children supported by ecls (n = ), there were no regional (p = . ) or national (p = . ) differences for prophylactic transfusions. however, significant differences in the tpc prior to therapeutic transfusions were observed on both a regional (p = . ) and national ( . ) basis with the middle east, in particular israel, transfusing at the lowest median (iqr) tpc [ ( - ) x cells/l]. for children with an underlying oncologic diagnosis (n = ), no differences were seen in the tpc for prophylactic transfusions (n = ) on a regional (p = . ) or national (p = . ) basis. nor were differences seen in the tpc prior to therapeutic transfusions on a regional ( . ) or national (p = . ) basis. there was significant variability in the dosing of platelet transfusions on both a regional (p < . ) and national basis (p < . ). the median (iqr) dose based on volume ranged from . ( . - . ) ml/kg in north america to . ( . - . ) ml/kg in europe. the vast majority of transfusions were leukoreduced and irradiated but significant variation exists in storage duration on both a regional (p < . ) and national (p < . ) basis. summary/conclusions: regional and national variation exists in platelet transfusion practices among critically ill children, especially in those given therapeutic transfusions while supported by ecls. considering this variation, comparative effectiveness studies may be an appropriate approach to gain evidence to optimize platelet transfusion thresholds. background: the optimal threshold for prophylactic platelet (plts) transfusion in pediatric patients with cancer is still controversial and current clinical practice comes from studies on adults and on inpatient setting. the international guidelines (icmtg, ) recommend, for all age patients, a prophylactic platelet transfusion when plts count is ≤ /l and a platelet dose of . per square meter (sm) of body-surface area (bsa) in inpatient and . /sm in outpatient setting. aims: in january we started in our children's hospital a prospective protocol in order to evaluate the impact on bleeding risk of current clinical practice of prophylactic platelet transfusion in inpatients and outpatients onco-haematological patients. methods: bsa was calculated from age-standardized weight. inpatients received a dose per transfusion of . /sm and outpatients a dose per transfusion of . /sm. platelets were transfused when the count was ≤ /l or in presence of bleeding signs; pediatric aliquots were obtained from buffy coat derived pooled platelet concentrates or apheresis platelet concentrates, according disponibility. results: from january to december a total of platelet pediatric aliquots were transfused: ( . %) were obtained from apheresis platelet concentrates and ( . %) from buffy-coat-derived pooled platelet concentrates. the majority of platelets pediatric aliquots ( - . %) were transfused to onco-hematological patients undergoing hematopoietic stem cells transplant (hsct) or conventional chemotherapy. among them, aliquots were transfused in inpatient setting: ( %) in the hematology unit, ( . %) in the oncology unit and ( . %) in hsct unit. a total of ( . %) aliquots were transfused in outpatient setting: ( . %) to patients affected by hematological malignancies and ( %) to patients with solid tumors. five major bleeding events (who grade ≥ ) were observed during the study period and all of them occurred in hospitalized patients. two patients with solid neoplasm developed a who grade bleeding event. two patients with hematologic malignancies and a patient with neuroblastoma (n = , . %) developed intracranial bleeding (who grade ). the platelet count at the time of the event was /l, /l and /l, respectively. summary/conclusions: our results showed the efficacy, in onco-hematological pediatric patients, of a prophylactic platelet transfusion protocol based on international guidelines: a very low incidence of who grade bleeding has been observed in inpatients setting only ( . % vs % of plado trial, sj slichter, nejm, ) , while in outpatients setting the double platelet dose prevents the major bleeding event (who grade ≥ ) occurrence. background: the problem of blood-borne infections remains relevant in transfusion medicine. pathogen reduction technologies (prt) provide a preventive approach to a wide range of transfusion-transmitted infectious diseases. to date, prt widely used for platelet concentrates and blood plasma, however, the use of these technologies for the treatment of red blood cell-containing blood products undergo research. aims: the aim of our study was to evaluate the safety and efficacy of transfusions of pathogen-reduced (test group) red blood cell suspensions (rbcs) and compare these data with gamma-irradiated rbcs (control group). methods: the technology based on the combined action of riboflavin and ultraviolet (mirasol prt, terumo bct, belgium) was used to reduce pathogens in whole blood. subsequently, the rbcs of the test group were derived from pathogenreduced whole blood. the control rbcs were irradiated at the gammacell elite (best theratronics, canada) at a dose of gray. all rbcs were used for transfusion for days from the harvest day. pediatric patients with various oncological and hematological diseases were randomized to groups of members in each group. the test group of patients received transfusions of a pathogen-reduced rbcs; the control group received transfusions of a gamma-irradiated rbcs. the next day after transfusion were assessed hemoglobin and hematocrit increment, the level of potassium and haptoglobin in the patients' serum, the frequency and severity of transfusion reactions. - days after the transfusion, the direct antiglobulin test (dat) was performed and after - days the indirect antiglobulin test (iat) was performed. the interval to the next need for transfusion was also evaluated. results: the increase in hemoglobin and hematocrit (p = . ), as well as the concentration of potassium (p = . ) and haptoglobin (p = . ) in the patients' serum after the transfusion did not differ between groups. none of the patients in both groups had hyperkalemia after transfusion. in each group, two patients had febrile non-hemolytic transfusion reactions of comparable severity (p = ). all dat and iat tests were negative in both groups. the interval between transfusions were not significantly different between groups (p = . ). only in the test group was found the correlation between the increase in the hemoglobin and hematocrit values with the volume of transfusion, with the dose and the adjusted dose of hemoglobin obtained for the transfusion on body weight. and in this group was found inverse correlation between the hemoglobin and hematocrit increment with the level of hemolysis in the rbcs. summary/conclusions: we found that the clinical efficacy and safety of rbcs of the compared groups did not differ. there was no evidence of immune elimination and allo-sensitization caused by pathogen-reduced rbcs. according to our data, the spectrum of efficiency and safety indicators of pathogen-reduced rbcs is no worse than that of gamma-irradiated rbcs, provided that rbcs is used for days of storage. the founded correlation suggests that the efficiency of pathogen-reduced rbcs transfusions is more dependent on the characteristics of the rbcs. background: patient blood management (pbm) programs are expanding at an international level. a recent nationally representative study from united states observed pediatric age group as the only age group showing lack of objective evidence of pbm initiatives (goel et al, jama ) . aims: this study aims to identify trends in peri-operative blood utilization in children undergoing elective and non-elective surgeries over years duration from to . methods: using years data ( ) ( ) ( ) ( ) ( ) perioperative transfusions decreased steadily per year from . % in to . % ( % cumulative decline) in for children of all ages (or . ; % ci . - . ; p trend < . ). the cumulative change in elective procedures was . % versus . % decrease in urgent/emergent procedures (p trend < . ). summary/conclusions: in this large prospective registry study of > , children undergoing elective/non-elective surgeries, a statistically significant decrease in utilization of peri-operative rbc transfusions was seen across years from through with more significant decrease in urgent/emergent procedures than elective procedures while these findings need evaluation for non-surgical indications of transfusion, these results may provide first evidence of peri-operative pediatric patient blood management strategies being implemented to optimize transfusions in pediatric population. adverse events -tti, immune interactions and risk c-s - transfusion-transmitted infections (tti) are a long-standing and well recognized concern in medicine, which is tackled on the highest level to guarantee the safety of the transfusion procedure for all stake holders. these include the recipient patients, the donating volunteers, the health care workers involved, and their respective contact persons. accordingly, current national and international guidelines including expert societies and the who provide medical, technical, and legal frameworks, which are the basis for the standard operating procedures. nevertheless, there are important challenges, which render tti a "moving target", and reflect the dynamics in three main areas. first, a change in the type and number of recipient patients with past or ongoing immunomodulatory / immunodeficiency component (examples being hiv/aids, sot, allogenic hct, monoclonal antibody therapies, small molecule inhibitors). second, changing exposure to known agents in donors due to global travel, migration and displacement, as well as environmental/climate change. third, discovery and diagnostics of old and new agents with their known or presumed impact as tti. these aspects will require careful review of data and studies, and judicious discussion of the potential action such as selection versus close monitoring to keep tti rates as low as possible, to deliver maximal safety of patients and stakeholders. background: the implementation of nucleic acid testing (nat) and the development of sensitive and specific serologic assays to detect hbsag and anti-hbc antibodies significantly reduced the risk of hbv transfusion-transmission. the apparent redundant testing for two direct viral markers prompted debates on maintaining hbsag screening, particularly in low endemic countries where blood donations are screened for anti-hbc. however, frequencies of - % of hbsag-confirmed positive/nat negative donations have been reported depending on the sensitivity limit of the molecular assays used. the nature of this discrepancy between hbsag and dna remains largely unknown and it is essential to evaluate any potential negative impact on blood safety before considering removing hbsag testing. aims: the prevalence in blood donors and the molecular mechanisms responsible for a persistent undetectable or barely detectable level of viral replication in the presence of a sustained hbsag production were investigated in a collaborative study including five laboratories/blood centers in europe and south africa. discrepancy between viral dna and hbsag levels suggested the presence of mutations that may negatively affect hbv replication and/or infectious viral particle production. methods: donor samples from france, south africa, poland, and croatia were selected for having hbsag levels ≥ iu/ml and being id-nat (procleix-ultrio plus tm [ % lod: iu/ml]) non-reactive/non-repeatable reactive (nr/nrr) with undetectable viral load (vl) or < iu/ml (n = ) or nat repeat reactive (rr) with vl < iu/ml (n = ). french samples initially tested nat nr/nrr with procleix-ultrio (lod %: iu/ml) were retested with ultrio plus prior inclusion in the study. hbv dna load was quantified (cobas taqman hbv [loq: iu/ml]). hbv dna was purified from to ml of plasma after ultracentrifugation. the whole hbv genome, pre-s/s, precore/core and bcp regions were amplified and sequenced. results: following viral concentration, hbv dna presence was confirmed in % of all samples with undetectable or vl < iu/ml. hbv genotypes were a ( . %), a ( . %), a ( . %), b ( . %), c ( . %), d ( %), and e ( %). all samples were anti-hbc positive and % of ultrio-negative samples tested positive with ultrio plus. unusual - nt insertions/deletions identified in bcp regulatory elements (tata boxes, pginr, epsilon domain) suggest altered viral replication. amino acid substitutions (n = ) or deletions (n = ) at positions reported involved in nucleocapsid formation, particle envelopment and virion formation were observed in the core protein of samples. the replicative properties of the bcp and core variants are currently evaluated in vitro as a surrogate model for direct infectivity testing. preliminary results indicate that the variants tested so far have replicative capabilities similar to those of control viruses. analysis of pol, s, and hbx proteins is ongoing. summary/conclusions: these data confirmed the presence of extremely low level of circulating dna-containing viral particles in id-nat non-reactive or nonrepeated reactive blood donations with concomitant high hbsag levels and anti-hbc reactivity. despite the presence of mutations in the viral genomes potentially affecting virion production, preliminary data indicate that some of the viruses in plasma retain the ability to replicate in vitro and to constitute a potential infectious risk. c-s - background: in switzerland highly sensitive nucleic acid screening in an individual donation format for hepatitis b virus (hbv id-nat) and hepatitis b surface antigen (hbsag) detection is mandatorily performed (guidelines of swiss transfusion src, switzerland). since , hbv (hb) vaccination is recommended in switzerland for children and adolescents until the age of and for adults belonging to known risk groups. aims: to highlight that low anti-hbs titers several years following hbv vaccination still confer protection and enable the host immune system to clear hbv dna without development of serologic markers of disease. methods: a retrospective donor interview was conducted to complete information not covered by the questions included in the standard donor questionnaire. routine hbv serological donor screening was performed on a quadriga system (diasorin, former siemens) with the enzygnost hbsag assay (diasorin, former siemens). further hbv tests were performed on the abbott architect i analyser (hbsag neutralisation, hbeag, anti-hbc igg/igm, anti-hbc igm, anti-hbe and anti-hbs). routine id-nat screening for hiv/hcv/hbv was performed with the roche cobas mpx test on a roche cobas platform. hbv id-nat positive samples were confirmed with a quantitative hbv nat assay (abbott). background: hepatitis b core-related antigen (hbcrag) is a structural antigen of hbv, consisting in hbcag, hbeag and the p cr precore protein. quantitative hbcrag measurement is a sensitive marker of viral replication reflecting the cccdna content and persistence of disease. hbcrag positivity was found to be a significant risk factor of hbv reactivation in hbsag-, anti-hbc+, hbv dna-patients (occult hbv infection, obi) undergoing immunosuppressive therapy. aims: no data about hbcrag status in apparently healthy subject with obi are available. the aim of this study was to analyse this marker in our cohort of obi blood donors. methods: hbcrag was measured in blood donors confirmed to be carriers of obi (hbsag-, hbv dna+). of them, / ( . %) donors were anti-hbc positive, and ( . %) negative. donors had both anti-hbc and anti-hbe reactivities. a group of young blood donors vaccinated for hbv infection (hbsag-, hbv dna-, anti-hbc-), and patients with chronic hbv infection (hbsag+, hbv dna+) were used as negative and positive controls group, respectively. serum hbcrag was measured using a chemiluminescent enzyme immunoassay on the lumipulse g automated analyzer (fujirebio, tokyo, japan). the lower limit of detection (lod) of the quantitative assay is logu/ml and the lower limit of quantification (loq) is > logu/ml, due to nonlinearity results between and logu/ml. levels of hbcrag were tested in the three groups and analysed in comparison to the presence of anti-hbc and anti-hbe. statistical analysis was performed by the ibm statistics spss . . . results: all donors in the negative control group had undetectable hbcrag levels, whereas all patients in the positive control group have detectable hbcrag (mean value: . logu/ml, range . - . ), confirming that individuals without prior exposure to hbv would not have detectable hbcrag. hbcrag was detectable in / obi donors ( . %), with a mean value of . logu/ml (range . - . ). hbcrag could be measured only in obi donors ( . and . logu/ml), being below the loq of the test in the majority of obi ( / ). considering the presence of anti-hbc, hbcrag was detected in / ( . %) anti-hbc+ and in / ( %) anti-hbc-obi, with no significant difference in their mean levels ( . ae . vs . ae . ; p = . ). interestingly, the presence of anti-hbe ( / ) was independently associated with higher hbcrag levels ( . ae . vs . ae . ; p = . ). summary/conclusions: identification of donors with obi is critical to prevent the risk of hbv transfusion-transmission. being hbcrag associated with the cccdna content and replication, our results suggest that the presence of hbcrag, even if not quantifiable, could be useful marker to confirm the occult infection status, even in anti-hbc negative donors. the association between hbcrag, anti-hbc and anti-hbe could also be a useful marker to identify obi donors with a higher risk of hbv reactivation. c-s - hc group. human peripheral blood mononuclear cells (pbmcs) from blood donors were stimulated with hbv polypeptides pool in vitro. t cell proliferation assays (cfse) was used to detecting t cell proliferation, enzyme-linked immunospot assay (elispot) was used to detecting the frequency of hbv-specific ifn-c secreted t cells. spss . statistical analysis software was used for statistical analysis. the measurement data of normal distribution were tested by two independent samples t test; and the comparison between multiple groups was analyzed by one-way anova. mann-whitney u test was used for comparison between non-normal data sets. p < . was considered statistically significant. results: . proliferation characteristics of t cells. the proliferation of cd + t lymphocytes was mainly stimulated by specific hbv polypeptide pool, and the proliferation rates of obi group and chb group were significantly higher than those of hc group ( . %, . % vs. . %), with significant difference ( . % vs. . %, p = . , . % vs . %, p < . ). . the frequency of specific ifn-c secreted t cells. the response intensity of the obi group ( sfc/ pbmcs) and chb group ( sfc/ pbmcs) was higher than that of the hc group ( sfc/ pbmcs) under the stimulation of hbv polypeptide pool, and the positive rate of t cell response to the stimulation of hbv polypeptide pool was the highest in the obi group ( . %). summary/conclusions: both obi and chb had higher rates of hbv-specific t effector cell proliferation and ifn-c secretion than the healthy control group. compared with the chb group, obi group had a higher positive rate of t cell response, which may be one of the causes of host immunity resulting in obi. further studies on other immune factors are required. background: western blood transfusion practices are currently changing due to various drivers such as blood management policies, ongoing technological developments, and new therapeutic options. in the netherlands, as in many high-income countries, these have resulted in a diminishing trend of red blood cells. therefore, it is important for blood bank management to anticipate the future demand of blood products for the sake of medium and long term decision making. to support this decision making, we have employed scenario development, which is used in many other sectors (such as finance and transportation) and can also be applied to blood transfusion. building upon a prior literature review and semi-structured interviews of international experts, we gathered experts together for scenario sessions to assess the opportunities and threats for sanquin's medium-term ( - years) strategy using an online platform and face-to-face discussions. aims: to assess for opportunities, threats, and the organizational implications thereof for the medium-term future of sanquin, the dutch national blood bank. methods: twenty-one multidisciplinary experts in blood transfusion agreed to participate and were separated into two groups for half-day interactive sessions. using an iterative process through an online platform, experts brainstormed opportunities and threats for sanquin, which were categorized into themes. these themes were ranked according to importance and certainty, and through consensus, experts chose two themes with high impact and high uncertainty. for these chosen themes, specific actions for the blood bank were listed to mitigate and/or enhance the threat or opportunity. discussions were ample throughout. results: with regards to opportunities and threats for sanquin's medium term strategy, experts brainstormed many ideas and categorized them under themes: political context/ changing legislation, novel products and alternative applications, donors, international markets, commercialization, digitalization, change in perceptions, research, demand, and organizational structure. after ranking for importance and certainty, six themes were chosen: change in perceptions, international markets, political context (opportunities), demand (opportunities), research (vulnerabilities), and donor (vulnerabilities). for each of these themes experts provided specific actions for the organizations to mitigate threats or stimulate opportunities accordingly. these actions included increased transparency and improved communication with the (donor) public, lobbying in political spheres, increased activities in educational institutes and large funding organizations, and creating and collaborating on novel blood products on an international level, to name a few. summary/conclusions: these results show that mapping and assessing a blood bank's future using a multi-disciplinary group of experts is conducive as an effective means of collection a diverse range of opportunities and threats. this provides an opportunity for blood bank management to become proactive towards these potential opportunities and threats and possibly evolve future strategies for the organization. showed that iron-deficient female blood donors were more likely to have depressive symptoms than non-iron deficient female blood donors. among participants with depressive symptoms, females with low plasma ferritin levels had significantly increased odds for reporting a "feeling of lacking energy and strength" (or = . ; % ci: . - . ). as it is known that blood donors are at an increased risk of iron deficiency, it is important to determine whether those genetically predisposed to lower plasma ferritin levels have a higher risk of experiencing the tiredness/lack of energy symptom. aims: to investigate whether there is an association between polygenic risk scores (prss) based on plasma ferritin levels and the tiredness/lack of energy symptom in blood donors. methods: the dbds is an ongoing nationwide blood donor cohort, of which genome-wide genotype data are available for , participants. genotyping was performed using the infinium global screening array (illumina â ) and imputation was achieved based on a scandinavian reference genome. ferritin prss, based on an icelandic ferritin gwas (n = , ), were calculated for all dbds participants. , female donors were available for the analysis. data on depressive symptoms were obtained using the validated major depression inventory scale (mdi), a selfreport mood questionnaire, which assesses the presence of depressive symptoms. a donor was classified as "tired" if they responded "all the time" or "most of the time" to the question "how often do you feel that you lacked energy and strength?". logistic regression analysis was performed, adjusting for age. for generating the quantile plots, the participants were distributed evenly into six quantiles based on their prs, whereby quantile contained the donors with the lowest prss (genetically predisposed to lower ferritin levels) and was set as the reference quantile with or = from the age-adjusted regression analysis (tiredness~quantile). results: prss in females ranged between - . and . (mean . ). a total of , female donors were classified as "not tired" and ( . %) were classified as "tired". no significant difference in ferritin prs was found between "tired" and "not tired" female donors (tired mean prs: . ; not tired mean prs: . ). an age-adjusted logistic regression model found this to be insignificant (or: . , % ci: . - . ), p = . ). to visualise the lack of association, a quantile plot was created, separating the female donors into six equal quantiles based on their prs. no clear trend was observed; donors with the highest prss (in quantile ) had or = . (p = . ) of being tired when compared to those in quantile (or set as ). summary/conclusions: no significant association was found between the ferritin prss of female blood donors and the tiredness/lack of energy symptom. further studies are needed to understand the effect of blood donation versus genetic constitution on tiredness among female iron-deficient blood donors. background: antiretroviral therapy (art) is critical for the control of clinical progression of human immunodeficiency virus (hiv) infections. however, the outcome of art could be limited by drug resistance-associated mutations (drms), even lead to the transmission of drug-resistant hiv to treatment na€ ıve patients such as blood donors, which is a huge concern to art. drms surveillance in hiv infected groups is strongly recommended by world health organization. characteristics of genetic diversity and drms of hiv among blood donors may provide comprehensive data to monitor viral evolution and optimize art, play important roles in blood safety. aims: limited data concerning the epidemic of hiv- subtypes and drms of blood donors is available in china. this study is to investigate genetic characteristics and drms of hiv- infected blood donors. methods: from - , blood donations collected from blood centers, covering almost the whole of china, were confirmed as hiv- positive by national centers for clinical laboratories using abbott realtime hiv- assay or cobas taq-man hiv- test, version . . then hiv- gag ( bp, hxb : - ), pol genes ( bp, hxb : - ) (encoding the whole protease (pr) and a part of reverse transcriptase (rt)) was sequenced after viral rna extraction and amplification. hiv- subtype based on gag and pr-rt regions was determined by comprehensive analyses of los alamos hiv blast tool, rega hiv- subtyping tool, phylogenetic trees and online jphmm program. drms analysis was performed in the stanford hiv drug resistance database. results: among donations, gag and pr-rt regions of samples were sequenced successfully. the distribution of hiv- genotype was as follows: crf_ bc = ( . %), crf_ ae = ( . %), b = ( . %), crf_ bc = ( . %), crf _ b = ( . %), crf _ b = ( . %), crf _cpx = ( . %), crf _ b = ( . %), crf _ = ( . %), crf _bc = ( . %), urf_ = ( . %) and urf = ( . %). of hiv- isolates were identified to have drms. there were ( . %, / ) protease inhibitors (pi) accessory drms, pi major drms and ( . %, / ) non-nucleoside reverse transcriptase inhibitors (nnrti) drms. most of blood donors with drms were crf _ae and crf _bc ( . %, / ). of pi accessory drms were q e. the pi major drms included m l, m i and n s. n s could result in hlr to atazanavir (atv) and nfv, llr to indinavir (idv) and saquinavir (sqv). v d/e is main nnrti drm ( . %, / ). a combination of v d and k r among two samples acted synergistically to reduce efavirenz (efv) and nevirapine (nvp) susceptibility. furthermore, two blood donors with k n mutation in reverse transcriptase gene had high level-resistance to efv and nvp. summary/conclusions: overall, the most prevalent subtypes among blood donors in the study were crf _bc ( . %), crf _ae ( . %). besides, other rare crfs and several urf_ and urfs were also found in these hiv- isolates, which suggested the epidemic of hiv has been shifted from high risk populations into general populations, including blood donors in china. drms were observed in . % donors in the study, which may result in resistance to pis and nnrtis, especially the hiv- variants with n s mutation in pr gene and k n mutation in rt gene. in summary, our findings indicate that increasing diversity of hiv- in blood donors and remind us the necessity of timely genotypic drug resistance monitoring and molecular epidemiology surveillance of hiv- among blood donors. background: labeling of platelets is required to measure the recovery and survival of transfused platelets in vivo. currently a radioactive method is used to label platelets. however, its' application is limited, due to safety issues and the inability to isolate transfused platelets out of the circulation. biotin-labeling of platelets is an attractive non-radioactive option, however, no validated protocol to biotinylate platelets is currently available for clinical purposes. aims: the aim of this study is to develop a simple, standardized, reproducible method to label platelets with biotin as a non-radioactive alternative to trace transfused platelets in vivo. methods: six pooled buffy coats derived platelet concentrates (pcs) stored in % plasma were biotinylated at day and day of storage. to distinguish the effect of the processing steps from the effects of biotin incubation, 'sham' samples were processed. for the biotinylation procedure, ml of pcs was washed twice and incubated with mg/l biotin, dissolved in phosphate buffered saline-pas-e ( : ), for min. stability of the biotin labeled platelets after irradiation was tested. annexin v and cd p expression were assessed as measures of platelet activation. applicability of this method to other platelet products was assessed in three pooled pcs stored in % pas-e and three single donor apheresis pcs. results: the method was reproducible performed in a closed system. after biotinylation, . % ae . % of platelets were labeled. platelet counts, ph and 'swirling' were within the range accepted by the dutch blood bank for standard platelet products. the number of annexin v positive cells was not significantly altered by the biotinylation procedure in both fresh and stored platelets. in contrast, cd p expression was increased in biotinylated platelets . % iqr( . - . %) compared to the control samples . % iqr( . - . %) on day of storage. however, biotinylated platelets were not more activated compared to sham samples % iqr( . - . %). thus only the procedural steps led to increased cd p expression and not the biotin label itself. all samples showed maximal response to thrombin receptor-activating peptide. for platelets labeled at day , a similar pattern was observed. irradiation of biotin labeled platelets did not alter the stability of the biotin label nor cell quality. furthermore this method is also applicable to pooled pcs stored in pas-e and apheresis pcs, with similar patterns in annexin v and cd p expression. summary/conclusions: we developed a standardized and reproducible protocol according to good practice guidelines (gpg) standards, for biotin-labeling of platelets for clinical purposes. the procedural steps, which are similar to the steps used for production of hyperconcentrated platelet products, led to an increased cd p expression, but did not alter the annexin v expression. this method can be applied as non-radioactive alternative to trace and recover transfused platelets in vivo. blocking activity over the prototypic chs insulator in cell lines and substantially reducing genotoxicity in a c-retroviral vector-mediated carcinogenesis mouse model. in contrast to chs , these insulators are small-sized ( - bp vs . kb) and can be easily accommodated in gt vectors without detrimentally affecting vector titers. aims: we aimed to test whether a , one of the newly discovered cis, could reduce vector-mediated genotoxicity in the challenging context of sin-lvs, by insulating a therapeutic globin-vector. methods: we tested the genotoxicity effect in the il- -dependent d cells, which upon transduction with oncogenic vectors become il- -independent, leading to transformation. d cells were transduced with sin-lvs: the b-globin-ΤΝs . . -, the insulated b-globin-a -tns . . and the oncogenic sffv-gfp-vector. transduced cells were expanded in % il- and transduction efficiency was determined by vector copy number (vcn). transduced d cells were seeded in methylcellulose with % or - % il- to detect the il- -independent and potentially transformed clones. the il- -independent clones were further expanded in % il- and infused in partially myeloablated and il- -treated c h/hej mice. wbc analysis, blood smears and bone marrow(bm) cytospins were performed. results: the a insulator did not negatively affect vector titers (ΤΝs . . , a -tns . . , sffv-gfp: . , . , . x ^ iu/ml, respectively). d cells were successfully transduced with all vectors (%vcn positive colonies: - %) and expanded up to -fold. the a -insulator decreased the number of il- -independent colonies by - % over the uninsulated vectors. the uninsulated vector-transduced, il- -independent colonies, were greatly expanded in culture with % il- over the a -transduced colonies (sffv, ΤΝs . . , a -tns . . : , , fold change, respectively). il- independence as a transformation event was confirmed in vivo by the development of overt leukemia (hyperleukocytosis, splenomegaly, bm-and extramedullary site-infiltration) in mice transplanted with the il- -independent and expanded colonies. summary/conclusions: under forced oncogenic conditions, the a insulator effectively protected a therapeutic vector from vector-mediated genotoxicity. a may serve as a safety feature in the construction of globin-sin-lvs. background: novel rare nucleotide substitutions are frequently identified in rhd, the gene encoding the immunogenic d antigen of the clinically-relevant rh blood group system, resulting in d variant phenotype. so far, it has been commonly accepted that substitutions of amino acids located either in a transmembrane or intracellular domain of the rhd protein induce weak d phenotype, i.e. reduced d antigen density at the surface of red blood cells. recently we showed by functional analysis using a "minigene splicing assay" (msa) that a decrease in d antigen expression may be due also to alteration of cellular splicing. aims: here we pay attention to the general disruption of this mechanism and the related phenotypic consequences in novel and previously reported single-nucleotide variations in rhd. we then sought to characterize functionally by msa novel candidate splicing variants in rhd. then we extended the project by studying prospectively all single-nucleotide variations reported in rhd exons, in order to assess globally the correlation between in silico prediction and functional analysis and to gain insights into the reliability of bioinformatics tools in line with the available phenotypic and/or clinical data. methods: seventeen novel or uncharacterized rhd variations, including missense, synonymous and intronic substitutions, were selected for functional analysis by msa in human cell models. a second set, including missense variants reported in rhd exons and , was further analyzed. functional data were compared with an algorithm derived from the quepasa method and tools available in the alamut suite. a published d protein model was used to visualize the location of missense amino acid substitutions and to assess potentially their respective phenotypic consequence. results: a novel "universal" minigene was validated and used successfully to characterize eleven novel splicing variants. those variants include six intronic and four missense substitutions close to the consensus dinucleotide splice sites, as well as the c. c>t synonymous variation associated with a weak d phenotype, which creates a de novo splice site. very interestingly, c. g>t (gly val; d-negative) disrupts totally normal splicing, while c. g>c (gly ala; weak d) and c. g>a (gly asp; d-negative) only partially alter the mechanism. further visualization of amino acid changes in a d model suggests that gly asp, but not gly ala, dramatically impair rhd protein structure/folding. subsequently the global analysis of mutations in rhd exons and by msa showed that inclusion of whole exon sequence in the mature transcript is significantly reduced in / ( . %) variants, which correlates well with the quepasa-like prediction (sensibility = . , specificity = . ). additionally, while normal exon inclusion is affected by c. c>g (weak d type ), the associated leu val substitution does not seem to be deleterious to the protein. summary/conclusions: on the basis of our functional data, this work shows that splicing disruption in the presence of rhd variants is a common and general mechanism that may act independently or synergistically with alteration of protein structure through amino acid substitutions, resulting in a weak d phenotype. it also illustrates the potency of combining functional tests and in silico tools towards the phenotypic/clinical interpretation of rare variants. background/aims: monetary and non-monetary incentives may support blood services in recruiting blood donors but have also been criticized for violating ethical principles and threatening blood safety by attracting donors with a high risk for infectious diseases. although incentives for blood donors have been discussed extensively over the past decades, empirical research on this topic remains limited. the aim of this study was to describe attitudes towards incentives for blood donors in europe and show donor return rates of compensated and non-compensated blood donors in south-west germany. methods: first, we present results of a secondary analysis of the eurobarometer, a nationally representative survey in all member states of the european union. in , participants were asked to evaluate eight potential incentives for blood donations as acceptable or unacceptable. these incentives were refreshments (e.g. coffee), physical check-ups (e.g. blood pressure), free (testing) laboratory parameters, free medical treatment, complimentary items (e.g. first aid kits), monetary travel reimbursements, additional cash reimbursements, and release from work. second, we conducted a retrospective analysis of donor return patterns of . compensated and . non-compensated donors who started donating blood at mobile and fixed donation sites. compensated donors received either eur as a regular reimbursement for their expenses (at a fixed donation site), in accordance with the german transfusion law, or a singular free entrance for an amusement park (at a mobile donation site). these compensated donors were compared with noncompensated donors who started either at a fixed or mobile donation site. chisquare statistics were used to test for differences in regular donor status after , , and months between compensated and non-compensated first-time donors. results: among german participants of the eurobarometer, physical check-ups ( . %), refreshments ( . %) and free (testing) laboratory parameters ( . %) showed the highest acceptance as an incentive for blood donors. travel reimbursements and free medical treatment were rated as acceptable by . % and . %, respectively. the lowest acceptance was for release from work ( . %), complementary items ( . %) and additional cash reimbursement ( . %). interestingly, the acceptance of potential incentives varies considerably across europe. in south-west germany, donor return of first-time donors differed significantly by type of compensation. among compensated first-time donors, who received eur as a monetary reimbursement, the proportion of regular donors after months ( . %) was significantly higher than among comparable non-compensated donors ( . %). however, a non-monetary compensation (free entrance) did not increase donor return rates. conclusion: the eurobarometer survey indicates that in most european countries monetary incentives are only accepted by a small minority. refreshments, checkups, free (testing) laboratory parameters and free medical treatment were most popular as incentives for blood donors. however, results of our four non-randomized donor samples from south-west germany suggest that monetary compensation may increase the likelihood of donors returning to fixed donation sites. regular monetary reward may therefore help to recruit regular donors especially in urban settings. incidentally, non-monetary compensation by a free entrance, however, may not affect donor return. background: previous research showed that whole blood (wb) donors that are temporarily deferred on-site are at higher risk of lapsing, yet very little studies have focused on differentiating the effects that different deferral reasons (e.g., travel, hemoglobin [hb]) may have on donor lapse. in addition, donor experience (i.e., firsttime or repeat donor) has also previously been found to affect donor lapse, yet novice ( - prior donations) and reactivated donors (returning after years of not donating) may respond differently. finally, it is currently unclear how and why different deferral reasons and donor experience interact in influencing donor lapse. aims: our aims were to understand ) how deferral reasons and donor experience jointly affect donor lapse, and ) why donors may lapse after temporary deferral. methods: a mixed methods approach was used. first, we used sanquin's donor database for a quantitative analysis of return behavior of all dutch wb donors between and (n = , ). the first wb donation for each donor was identified as the target donation. lapse was defined as non-return within a followup period of two years after the target donation. target donations included % new donors, % novice donors, % experienced donors, and % reactivated donors. deferral reasons included travel, hb, medical short-term (< days duration), medical long-term (> days duration), and miscellaneous. next, we interviewed temporarily deferred donors to understand the deferral process from their perspective. semi-structured interviews were used to understand how these donors cognitively and emotionally experienced on-site temporary deferral. we analyzed the interviews (using the framework approach, cf. hillgrove et al., bmc public health, ) to identify key topics and underlying themes. results: of target donations, % were deferred, mostly for travel ( %), medical short-term ( %), and hb ( %). survival and time-to-events methods showed that the different deferral reasons and donor experience levels differentially impacted donor return or lapse. importantly, experience and deferral interacted in influencing return (rate). for instance, deferred new donors were more likely to lapse than eligible or experienced donors (ors < . , p's< . ). even though deferral also affected return of experienced donors, this effect was smaller or even non-existent for certain deferral reasons (e.g., travel-and hb-related deferrals). qualitative results showed that almost all donors experienced temporary deferral as disappointing, particularly when it was unexpected (e.g., first-time deferral). not all donors (fully) understood the aims of deferral or how to prevent on-site deferral. donor beliefs about why deferral would lead to lapse were related to recurring deferrals, (mistakenly) interpreting deferral as permanent, or feeling all the effort did not pay off. summary/conclusions: reasons for temporary deferral differently impact risks of donor lapse at different levels of donor experience. for new donors all reasons for deferral are related to higher risks of lapse, whereas some reasons for deferral seem not to affect lapse among more experienced donors. unexpected or recurring deferrals may explain why donors lapse after temporary deferral. blood banks may tackle disappointment after deferral by explicitly showing that the donor is still valued, for instance by using personalized communication or offering an alternative good deed. background: blood donors experience a temporary reduction in their hemoglobin (hb) value after whole blood donation. in the netherlands, the hb value is measured before each donation, and a too low hb value (cut-off values: . mmol/l ( g/l) for men and . mmol/l ( g/l) for women) leads to a deferral for donation, in order to prevent iron deficiency and anaemia. the minimum interval between two donations is internationally set at weeks, but over time donors exhibit iron deficiency so that blood donors are temporarily deferred from donation each year. in the us % - % of deferrals are due to low hb, especially in women (editorial, transfusion, ) . due to the recovery process after each donation and the unobserved heterogeneity of donors, advanced statistical methods are needed to model the longitudinal data of hb values of blood donors. aims: to estimate the shape and duration of the recovery process of hb until the hb value has returned to its pre-donation level, to assess whether one can distinguish between donors with fast and/or slow recovery of their hb level and to predict future hb values. methods: the study is based on data of the donor insight study, which was a prospective cohort study performed by sanquin in the netherlands from to . we employed three statistical models for the hb value: (i) a mixed-effects models, (ii) a latent-class mixed effects model, and (iii) a latent-class mixed-effects transition model. in each model, a flexible function was used to model the recovery process after donation. the latent classes identify groups of donors with fast or slow recovery times, and donors whose recovery time increases with the number of donations. the transition effect accounts for possible state dependence in the observed data. all models were estimated in a bayesian way, using data of a sample of new entrant donors ( males and females). prior information from the clinical literature (boulton, vox sanguinis ) about the recovery process three days after blood donation was incorporated into the analysis since these values were not identified in the observed data. results: the results show that the latent-class mixed-effects transition model fits the data best. we also found that the recovery process shows a concave process (initially fast followed by slower recovery). the estimated recovery time is much longer than the current minimum interval of days between donations. namely, depending on the subgroup that the donor belonged to, males showed a recovery time of to days, while the estimated recovery time for females varies between to days. these results suggest that an increase of this interval may be warranted. summary/conclusions: the analysis shows the usefulness of the sophisticated statistical models that make use of historical information to model complex processes in time, in this case the hb trajectory over time across repeated donations. in addition, our results suggest a (much) longer time lag between subsequent donations to avoid anemia. background: complications of blood donation are known to reduce donors' return for future donation. the episode study (experience success in donation) showed that water drinking shortly before donation had an effect of % reduction of selfreported vasovagal reactions (vvr) in younger novice whole blood donors (wiersum-osselton, transfusion, ) . aims: in this study we analysed the return for a subsequent donation of the donors participating in the episode study. this was a predefined secondary outcome of the episode study. methods: the episode study was conducted in young (< years) whole blood donors making their first, second, third or fourth donation in geographically selected collection centres. the study interventions were: ml water drink, ml water drink or squeezing a ball (placebo intervention) during the wait after the screening interview and before phlebotomy, and a control group without intervention. participating donors were sent an online questionnaire about their experience within a week following their donation attempt. in the netherlands donors are usually invited for blood donation in accordance with hospitals' needs; the aim is to invite eligible donors at least once a year. donors were included in the return analysis if they had received at least one invitation within days after the index donation and we analysed their return for a donation attempt within days. associations with the interventions and donors' donation status, gender and reported symptoms at their index donation were analysed by calculating return percentage of eligible donors and by binomial logistic regression. results: out of the episode participants who had received an invitation, ( . %) returned within the study period. there was no difference in donor return between the two water groups. the likelihood of return was significantly increased in both water and placebo intervention donors compared to the questionnaire group (or . , % ci . - . and . , . - . respectively). return was slightly lower in women (or . , ) and lower in first-time donors (or . , . - . ) than after a nd - th donation. a staff-recorded or self-reported vvr at the index donation reduced donor return (or . , % ci . - . and or . , . - . respectively). other symptoms following donation were also associated with a lower return percentage. summary/conclusions: in this cohort of younger new and novice blood donors, . % returned for a subsequent donation. a vvr (either staff-recorded or selfreported) reduced donor return. donors who received a study intervention, either water or placebo, were more likely to return, whether or not they had suffered a vvr. it is conceivable that the mere fact of study participation could also have increased donor return, even in de questionnaire group; this will be examined in the total population of target group donors. background: the contribution of older blood donors to the blood supply is substantial. in australia, donors aged > years contributed % of all donations made in . however, with ageing, the general health status of older donors changes relatively faster, thus progressively affecting their ability to donate. an indepth understanding of the relationship between older donors' health status, future donation patterns, and risk of iron-deficiency could be of a great value to inform the blood service to predict the number of future donations, and manage the risk of iron-deficiency. aims: to understand the relationship between self-reported health, blood donation patterns, and the management of identified iron-deficiency in older blood donors. methods: we linked the sax institute's and up study baseline data collected between and to the blood service donation records, inpatient records, and medicare records*. the data-linkage was conducted by centre for health record linkage. using these linked data, we examined the relationship between health, donation patterns, and iron-deficiency and its management. results: we followed up , active whole blood donors for , eligible person-years (average age at recruitment . years, . % female, average follow up . years per-person). after adjusting for the effect of age, sex, body-mass index, education, non-english language spoken at home, country of birth, smoking, physical activity, regular use of multivitamins, alcohol consumption at enrolment, and total number of whole blood donations in the years prior to enrolment, participants with better self-reported health at recruitment showed significantly higher rates of donation. excellent, very good, good, and fair/poor health status donors made ( % ci - ), ( - ), ( - ), and ( - ) donations per person-years, respectively. iron-deficiency was identified in . % of donors in the study (n = , % ci . - . ) . sixty percent of those with iron deficiency (n = , , % ci . - . ) visited their general practitioner (gp) within days of the identification of irondeficiency, and . % ( % ci . - . ) of those visiting gp underwent further iron status examination and monitoring. after adjusting for several potential confounders including the total number of donations made during the follow-up period, excellent self-reported health status was independently associated with lower risk of iron-deficiency (p for trend = . ). summary/conclusions: information on self-reported health status can be an effective indicator to estimate the future donation yield of an older blood donor panel, and risk of developing iron-deficiency. donors with better self-reported health had a higher number of future whole blood donations and a lower risk of iron-deficiency. donors referred to gps for management of their iron status utilised the health services as expected, however there is an opportunity to improve their contact with their gps. * medicare records was provided by australian government department of human services. anaemia is a major public health issue, affecting % of the population worldwide according to the world health organization. iron deficiency is responsible for approximately half of all cases globally, with other causes including anaemia of chronic disease, other nutritional deficiencies, haemoglobinopathies, renal impairment, malignancy and bone marrow disease. in the elderly, where anaemia is even more common, the cause is frequently multifactorial. anaemia is associated with increased mortality, decreased cognitive and physical function, depressive symptoms and fatigue, particularly in older adults. poor outcomes have also been reported in anaemic patients with underlying comorbidities such as cardiac and renal disease, and cancer. within a hospital setting, anaemia is highly prevalent. preoperative anaemia, affecting up to % of patients, is associated with poor clinical outcomes including higher in-hospital mortality, longer length of stay and higher icu admission rates. anaemia management requires a proactive and multi-faceted approach, typically involving a multi-disciplinary team in which the transfusion practitioner plays a vital role. this includes screening of high-risk patients and pre-admission clinics to identify and manage patients at high risk of peri-operative anaemia. implementation of patient blood management (pbm) guideline recommendations has been shown to be effective to prevent and optimally manage anaemia within the community and hospital settings. the transfusion practitioner has key roles in the coordination, monitoring and auditing of pbm programs. active patient involvement and engagement of all members of the multidisciplinary team, including primary care clinicians, are also key to enhance the success of such programs. tp - the role of the transfusion practitioner in anaemia assessment and management: processes, tips and resources for creating background: patient blood management (pbm) is an evidenced based integrated multi-disciplinary approach aimed to improve clinical outcomes by effectively managing and conserving the patient's own blood, thus reducing unnecessary exposure to transfusion. pbm has the patient as the central focus with the aim being to improve their outcomes and include them in the process. pbm includes three pillars: ) optimising the patient's own blood, ) minimising blood loss and ) optimising a patient's physiological tolerance of anaemia. delayed assessment/management of anaemia contributes to increased health costs and unnecessary blood transfusions, and transfusion has been recognised to be associated with increase morbidity and mortality. the term transfusion practitioner (tp) includes those known as transfusion nurses, transfusion safety officers, haemovigilance officers, or patient blood management (pbm) coordinators. a key aspect of the role is driving and influencing clinical blood management activities to help align practice to internationally recognised guidelines and standards, including pbm. aim: to demonstrate the tp role in anaemia assessment & management and discuss strategies, processes, tips and resources for creating organisational and cultural change to implement pbm. context: literature outlines the importance of a multidisciplinary team to implement pbm related changes, and tps play a fundamental role within these teams to support 'buy in'. tps are seen as enablers, pulling resources together, engaging with those involved, providing education and facilitating change. they are often the ones to conduct audits, collating data and evaluating outcomes. approaches to implement pbm should be tailored to suit individual organisations. the authors will outline different approaches, highlighting where the tp can support or lead activities. one approach to anaemia assessment is to undertake an audit, examples of available tools will be shown. with this data, the tp along with the pbm team can explore options for corrective action. these could include interventions such as developing a pathway where all or a specific group of patients are assessed and or treated either at a preoperative clinic, or with their local general practitioner; through to more complicated strategies such as establishing anaemia clinics. the skills of the tp are a valuable asset to analyse clinical specialties/patient mix who should be targeted to achieve best outcomes, they know the organisation and as such are well placed to help develop a process/concept that will suit, and they can provide education and support to promote and embed these practices. conclusion: appropriate assessment and management of anaemia requires a multidisciplinary approach. the tp plays an active and crucial role in this team. examples of processes, tips and resources to support change and embed a pbm culture across the clinical spectrum will be shared. d-s - department of hematology and central hematology laboratory, inselspital bern, bern, switzerland immune haemolytic anaemia (iha) is characterized by an increased breakdown of red blood cells (rbcs) due to allo-and/or autoantibodies directed to rbc antigens with or without complement activation. clinical and laboratory signs of haemolysis in concert with the presence of a positive direct antiglobulin test characterize iha. alloantibodies formed during pregnancy and/or after prior transfusions may cause acute or delayed haemolytic transfusion reaction after transfusion of a rbc product incompatible with the specificity of the alloantibody. autoantibodies to rbcs reduce the survival of endogenous and hamper the recovery of donor rbcs after transfusion. lymphoproliferative disease, autoimmune disease, infection or drugs often cause autoantibodies to rbc, but frequently no obvious cause can be identified. besides the antigen specificity, the isotype critically determines the biological activity of rbc antibodies in vivo. the isotype defines the affinity to fc-gamma receptors on cells of the reticuloendothelial system as well as the capacity to activate the classical pathway of complement, igm being the most effective. antibody-mediated complement activation results in the opsonisation of rbc with c bc/c d with subsequent complement receptor-mediated removal by phagocytes (extravascular haemolysis). occasionally, complement activation proceeds via the activation of c to the formation and insertion of the membrane attack complex resulting in intravascular haemolysis. there is growing evidence that the innate immune system plays an important role in the pathogenesis of iha. the process of complement-mediated haemolysis results in systemic inflammation, which contributes to morbidity and mortality of patients suffering from iha. complement activation results in the release of anaphylatoxins, which are strongly vasoactive and mediate chemotaxis, inflammation and formation of radical oxygen species. release of cell-free haemoglobin and cell-free haeme upon haemolysis induces endothelial cell activation, no-depletion, cytotoxicity, ros formation and neutrophil activation. natural plasma scavengers, such as haptoglobin and hemopexin complex with their target molecules, cell-free haemoglobin and haeme, with subsequent removal of the complexes via cd and cd -mediated phagocytosis. although being positive acute phase proteins due to consumption the plasma scavengers become exhausted during chronic haemolysis thereby failing to prevent the adverse biological effects of cell-free haemoglobin and haeme in the circulation. inducible haeme oxygenase- (ho- ) is an efficient cellular scavenger by breaking down haeme into biliverdin with subsequent formation of bilirubin, co and ferrous iron with subsequent oxidation to ferric iron and storage by the ferritin h chain. ho- has an established role in the systemic protection from systemic inflammation induced by haemolytic and non-haemolytic diseases. the lecture will emphasise the role of innate immunity with a special focus on different plasma-and cellular systems involved in the pathogenesis of systemic inflammation in patients suffering from iha. d-s - understanding erythrocyte clearance c roussel, p amireault, p ndour and p buffet research and teaching, institut national de la transfusion sanguine, paris, france the clearance of erythrocytes is essential in physiology, disease and transfusion. elimination of erythrocytes altered because of senescence or pathological processes is expected to protect the microcirculation from obstruction by adhesive or rigid erythrocytes. it also contributes to the harmful consequences of anemia and hemolysis in hereditary and acquired red blood cells diseases as well as in conditions associated with auto-or allo-immunization. immunobiology has explored in great details antibody-mediated clearance of erythrocytes but conventional approaches may not be fully operational to explain delayed hemolytic transfusion reactions. some important clearance processes are independent from the recognition of molecules or antigens on the erythrocyte surface. increased erythrocyte stiffness triggers their clearance in hereditary spherocytosis, malaria and possibly also in the context of autoimmune anemia. knowns and unknowns on the mechanisms and sites of erythrocyte clearance will be presented based on a critical review of old and recent contributions. d-s - cardiovascular and endocrine-metabolic diseases and aging, istituto superiore di sanit a, rome, italy existing literature indicates that red blood cells (rbcs), beyond gas transport, exert a complex role in human physiology, being involved in many functions essential to maintain ion, metabolic and immunological homeostasis. rbcs display an immunomodulatory activity on adaptive immune cells by promoting t cell growth and survival and inhibiting activation-induced cell death. the balance between cell death and survival controls t cell homeostasis and anomalies in this balance account for diseases linked to excessive or faulty t cell growth. rbcs are able to modulate innate immunity by binding endogenous molecules such as chemokines and mitochondria-derived dna, as well as external agents such as pathogens. rbcs can also directly modulate innate immune cell activation or tolerance by controlling the maturation of the circulating pro-inflammatory subset of dendritic cells (dcs). these cells are potent inducers of primary antigen-specific t cell responses, produce tnf-a when stimulated by lps and are the principal il- p -producing cells among leukocytes. the pro-inflammatory capacity of circulating dcs is controlled by rbcs that are able to inhibit their maturation and il- production. in diseases characterized by local th inflammatory response such as psoriasis vulgaris and rheumatoid arthritis, pro-inflammatory dcs play a role in the induction and perpetuation of inflammation. collectively, literature data indicate that rbcs exert important modulatory functions that may result in immune activation or quiescence, depending on the environmental conditions. when rbcs encounter a microenvironment characterized by an intense production of ros, the rbc defenses get overwhelmed or are unable to counteract the new pro-oxidant status and become themselves a source of ros, which cause the generation of senescent signals on rbcs. the major feature of oxidized rbcs is the clustering and/or the breakdown of band . other features are the complexation of hb with spectrin, the loss of glycophorin a, the externalization of phosphatidylserine and the reduction of the "marker of self" integrin-associated protein cd . a similar senescence phenotype has been documented in rbcs during the storage period. oxidized, senescent or stored rbcs, due to surface antigen modification and to the release of pro-inflammatory molecules, fail to control immune cell homeostasis thus contributing to the perpetuation of inflammation and to the pathogenesis of immune-mediated diseases associated to oxidative stress, such as autoimmune diseases and atherosclerosis. our research group demonstrated that rbcs from patients with carotid atherosclerosis presented a senescent phenotype similar to that acquired by rbcs from healthy subjects following to in vitro oxidation. oxidized erythrocytes fail to control t lymphocytes apoptosis and lipopolysaccharide-induced monocyte-derived dc maturation, thus representing dangerous signals for adaptive and innate immunity and contributing to the pathogenesis of atherosclerosis. in conclusion, the crosstalk between rbcs and the immune system represents a mechanism to maintain immunological homeostasis. however, in high oxidative stress conditions, that can take place during a prolonged storage period or in particular diseases, rbcs can acquire a pro-oxidant behaviour and lose their functional and homeostatic features. by interfering in immune system homeostasis, rbcs become a potential tool that can be manipulated to improve or reverse pathological situations characterized by anomalies in the control of adaptive and innate immunity. transfusion therapy remains an important treatment modality for patients with sickle cell disease (scd). transfusions are given to lower the percentage of circulating sickle rbcs, and to decrease blood viscosity and have been shown in clinical trials to reduce the risk of stroke by %. however, many indications for transfusion in scd remain controversial partly due to insufficient randomized clinical trials data and in part because of our limited understanding of the complex pathologic networks leading to diverse disease complications in scd despite the common single mutation. similarly, we have incomplete mechanistic understanding of why chronic transfusion protocols must be continued for those indications supported by clinical data. the beneficial effects of transfusion therapy in scd need to also be weighed against potential transfusion risks including alloimmunization associated with lifethreatening delayed transfusion reactions, increased iron stores associated with increased oxidative stress and exposure to infectious agents. we believe that a deeper understanding of the benefits as well as harmful effects of transfusions is crucial to optimize our current transfusion therapy protocols in scd. this knowledge may provide highly needed guidance, which is currently lacking, for expansion or limiting existing indications for chronic transfusions in scd. d-s - treatment of thalassaemia department of pediatric hematology, ege university, faculty of medicine, bornova/ izmir, turkey thalassaemia is a devastating blood disease with a significant worldwide burden. annually, , children are born with a major thalassemia. life-time rbcc transfusions and iron chelation remain standard of care treatment in thalassaemia. transfusion therapy still account for significant iron overload related morbidity and mortality despite chelation therapy which is associated with poor adherence, safety concerns and varied efficacy. higher risk for transfusion transmitted infections (ttis) exists for thalassemia patients whose transfusion exposure sustains lifelong. although, the risk of transmission for traditional viruses is exceedingly rare in the modern era, emerging infectious diseases continue to be recognized as potential threats to transfusion safety. the inadequacy of blood safety points to the necessity for an additional layer of security for the blood supply in the developing world. pathogen reduction technologies for rbcc may imply a proactive, more generalized approach against new and re-emerging pathogens in the developed world and may be an ultimate safeguard for transfusion safety in the developing countries. rbc alloimmunization may become a major challenge in thalassaemia management. prevention is the key reducing the burden of alloimmunization. while the recommendation is to transfuse thalassaemic patients with c/c,e/e,kell compatible blood, it is not universally practiced. extended molecular rbc typing may be an appropriate adjunctive test in addition to serological typing before embarking on transfusion therapy. if a complete rbc antigen profile has not yet been performed in an alloimmunized patient, genotyping is the only option for accurate detection of rbc antigens that may guide the antibody identification. allogeneic stem cell transplantation (a-sct) is the only available curative therapy in children with hla matched sibling which is available to approximately % patients. in the absence of msd, mud transplant with high compatibility criteria has still limited experience. mismatch related, cord blood and haploidentical donor scts are considered experimental. a-sct carries a substantial risk of saes and mortality, both increasing with recipient age and disease severity. dfs is % in paediatric and % in adults. gene therapy for correction of the a-globin chain imbalance overcomes the problems of donor availability and immunologic complications associated with a-sct. multicenter clinical studies on gene addition therapy by using self-inactivating lentiviral vector are currently underway. recently, gene editing by either gene disruption or gene correction emerged as a potential alternative to gene addition therapy in beta-thalassaemia. a new era of novel therapeutics is unfolding in thalassemia management. several targets have been identified that can improve alpha/beta chains imbalance, ineffective erythropoiesis, or iron dysregulation and a number of those now have agents in preclinical and clinical development. hydroxyurea may improve globin chain imbalance and be beneficial for reducing or omitting transfusion requirement in selected group of patients. ruxolitinib has shown the limited effect on pretransfusion haemoglobin and reduction in transfusion needs, but allowed steady decrease in spleen volume that may serve for avoiding splenectomy in beta thalassaemia. luspatercept may restore normal erythroid differentiation and improves anaemia and hepcidin mimetics or tmprss inhibitors may modulates ineffective erythropoiesis by iron restriction and improves anaemia and organ iron loading. background: thalassaemia major (particularly b-type) and sickle cell disease (scd) are the commonest clinically important haemoglobinopathies, representing major sources of morbidity. recommended therapy is regular transfusion of safe, good quality blood, and monitoring of related complications. thalassaemia international federation (tif) guidelines, in place since , include strategies for precautionary measures and use of scientific progress in detection, inactivation and elimination of transfusion transmissible pathogens. antigen-matching strategies to avoid alloimmunization against rbc antigens and other measures including haemovigilance are key components for safe blood, alongside voluntary, non-remunerated blood donation and laboratory quality assurance programmes. aims: we present the contribution of tif and the greek experience in ensuring safety and availability of blood for thalassaemia patients applying internationally accepted standards and recommendations. methods: tif -a non-profit, patient-driven organization with national thalassemia associations in countries -promotes national control programmes for prevention and management contributing to the achievement of final cure. the main working methods are provision of education, expert support, networking, communications and projects to support improvements in the quality of health, social and other care. in greece, technical standards for blood donor selection and testing are applied in compliance with directive / /ec as well as haemovigilance programmes and traceability procedures for recording adverse reactions and events associated with the transfusion of rbcs (directive / /ec). pre-transfusion and transfusion measures recommended by the council of europe are applied. in particular, measures for transfusion of "the right blood at the right time for the right patient", leucodepletion, rbc washing and accurate cross-matching and antigen and antibody screening for an extended matching policy are practised. fresh (up to days old) rbcs are used. molecular testing for abo and rh d is performed in cases with blood group discrepancies. haemovigilance in greece covers % of total blood supply. data on ttis in , patients with thalassaemia and scd-thalassaemia in - are analysed. results: tti prevalence in thalassaemia syndromes was: hbv . % (occult type . %), hcv %, hiv . %, htlv . %, wnv . % and hev %. most frequent adverse reactions in - were allergic (incidence : ), non-haemolytic febrile reactions : , , "other" : , , alloimmunisation : , , taco : , , tad : , , tt-hev : , . hyperhaemolysis was diagnosed in two scd patients, delayed haemolytic transfusion reaction in one thalassaemia intermedia patient. trends in - show reduced incidence of alloimmunisation against rbcs. rates of allergic and pyrexial ars remained stable. no major abo incompatibility case was reported and no fatal transfusion reaction of transfusion has been recorded. summary/conclusions: blood safety in transfusion has significantly improved in high and upper-middle income but unfortunately not in lower and low income countries. blood shortages and lack of stringent protective measures for thalassaemia patients is the reality for many developing countries. tif focuses particular attention on the provision of support and the promotion of initiatives promoting the safety and adequacy of blooda key component of the lifelong management of patients with transfusion-dependent thalassaemia. background: b thalassemia is the most common group of hereditary hemoglobinopathy diseases. affected people with major thalassemia are dependent on regular blood transfusion which leads to iron overload. hepcidin is a peptide and an important regulator of iron homeostasis. expression of this hormone is influenced by polymorphisms within the hepcidin gene, hamp. aims: this study aimed to analyze the association of three polymorphisms in promoter of hamp, rs , rs , and rs with iron overload in major b thalassemia patients who do not respond to iron chelating therapy. materials and methods: a total of samples from major b thalassemia patients were collected. genomic dna was extracted and sequenced for snps rs , rs , and rs . statistical analysis was performed on ibm*spss* statistic using independent t test and fisher test. results: our analysis revealed statistically significantly difference between the level of cardiac iron concentration and c.- a>g variant (p = . ). for rs statistical analysis was on the edge of significant relationship between minor allele and serum ferritin (p = . ). all samples were homozygous for allele t of rs . summary/conclusions: different factors affect iron overload in thalassemia. our findings and others emphasize the role of hepcidin polymorphism as a key component in iron homeostasis. ten to twenty years ago, countries in south eastern africa faced the peak of the devasting hiv/aids epidemic leading to an up to years drop in general life expectancy. with the burden of hiv/aids falling mainly on the economically active population of young and medium-aged adults, the epidemic endangered social and economic stability in nations most heavily affected. today, despite aids still being a major cause of death in south eastern africa, the epidemic has become an example of public health gains that can be achieved through programmatic, evidencebased approaches that are endorsed by globally aligned policy and funding strategies. based on his work from lesotho, where one out of four among adults is infected by hiv, niklaus labhardt will take the auditors through the history of hiv programs in south eastern africa and show how innovative, pragmatic and evidence based implementation brought the region to a stage where the goal to end the aids epidemic by might be in reach. background: in france, the deferral for men who have sex with men (msm) was reduced from permanent to months in july . since this change has not impacted the residual risk (rr) of undetected hiv among blood donations, the ministry of health is considering a greater access of blood donation to msm. two scenarios have been studied: s . deferral of msm during the months preceding the donation; s . deferral of msm who have had more than one sexual partner in the months preceding the donation, similarly to all other blood donors in france. aims: to assess the impact of these two scenarios on the hiv rr estimated over the period july -december which is the baseline rr with the current month deferral for msm. methods: baseline hiv rr was calculated with the classical incidence-window-period method, where hiv incidence was derived from a detuned assay (eia-ri) detecting recent infections (≤ days) since all hiv- antibodies positive blood donations are tested with this test. the assessment of the impact of both scenarios on the baseline hiv rr was based on (i) data obtained from surveys among msm in the general population and in blood donors (compliance survey), to estimate the number of additional msm who would give blood in each scenario, and on (ii) hiv incidence estimate among these additional donors. this incidence was estimated: for s , from msm blood donors with the current deferral policy ( months) and for s , from monogamous msm of the general population. results: from july to december , / ( %) hiv- positive blood donors tested with the eia-ri were identified as recently infected, allowing to estimate the baseline hiv rr at . in million donations [ % ci: . - . ], or in , , donations. for s , the number of additional msm donors was estimated at and the number of additional hiv positive donations at . , resulting in an hiv rr of . in million donations [ % ci: . - . ] or in , , donations. for s , the number of additional msm donors was estimated at , and the number of additional hiv positive donations at . , resulting in an hiv rr of . in million donations [ % ci: . - . ] or in , , donations. sensitivity analysis shows that if both the number of msm and the hiv incidence were multiplied by . , the risk would be in , , donations for s , and in , , for s . summary/conclusions: for both scenarios, the hiv rr remains very low. for s ( -month deferral), the risk is identical to the baseline rr and is very robust to variations in the model parameters. for s (no more than one sexual partner, months), the risk is . higher than the point estimate of the baseline rr and sensitivity analysis shows that this estimate is less robust than for s , since the risk could be times higher than the baseline rr. for both scenarios, there was a modest increase in eligible msm donating. d-s - background: recruiting safe blood donors amongst the largest hiv-positive population in the world is a major challenge for south african blood transfusion services. south african donor deferral criteria and deferral periods for perceived high risk activities have evolved over time, but current risk factors for infection have not been formally assessed. in addition, most studies have reported risk factors for prevalent hiv infection whereas risk behaviours for incident infection are more informative as donations with these infections could occur during the window periods of available screening assays. aims: to identify the demographic and behavioural risk factors associated with incident hiv infection among blood donors in south africa. methods: we conducted a case-control study with incident hiv-infected blood donors compared to infectious marker negative controls. incident hiv cases and controls seronegative for hiv, hepatitis b and c viruses and syphilis were accrued from a donor pool covering of provinces in south africa. controls were frequency matched at a : ratio to cases on race, age and geography. incident hivinfections were hiv rna positive by individual donation nucleic acid amplification testing (id-nat; procleix, grifols) but antibody (ab) negative (prism, abbott) as well as those rna+/ab+ donors with recently-acquired hiv based on limiting antigen avidity (lag) assay results with normalized optical density values of < . . eligible cases and controls completed a confidential audio computer assisted structured interview (acasi) on motivations for blood donation and behavioural factors, including behaviours in the months before donation. frequencies and measures of statistical association for risk behaviours comparing cases and controls are reported after adjusting for multiple comparisons. results: from november to january , we enrolled incident hiv cases and controls; ( . %) cases and ( %) controls were ≤ years old. there were significantly more female cases ( . %) than female controls ( . %) (p < . ). significant hiv risk factors (all p < . ) reported within the -months before donation included: having a primary sex partner who is male; reporting increasing numbers of male sexual partners for both females and males; frequency of vaginal sex; frequency of vaginal sex without condoms; use of methods to clean, dry, or tighten one's anus before sex; and having visited a traditional healer for medical care. lack of medical aid (private health insurance) and reports of injury or accident with blood loss were also associated with an incident hiv infection. summary/conclusions: our study has identified a set of novel, putative risk factors for incident hiv infection among south african blood donors while confirming a number of previously known sexual risk behaviours. not having private health insurance and being injured may be markers of socio-economic context that place individuals at higher risk rather than behaviours that directly increase hiv transmission risk. the detection of risk behaviours by acasi in donors who passed predonation questionnaires and interviews suggests that acasi has the potential to improve risk behaviour identification. background: in france from to , among male blood donors (mbds) found hiv- positive at blood donation screening, % did not disclose any risk factor for hiv infection during post-donation interviews, while % reported having sex with men (msm), and % and % reported heterosexual sex (hts) and other risk factors, respectively. aims: in order to gain new insights into the risk factors for hiv- infection in mbds, we performed an hiv- genetic network analysis, including hiv- positive mbds and patients included in the french primary hiv infection anrs co primo cohort (pc). methods: mbds, who donated blood between and , and pcs, included between and , were studied. epidemiological data were collected by the french blood service (efs) upon blood donation or post-donation interviews for mbds, and upon inclusion for cps. viral strains were sequenced and genotyped in pol gene, and a recent infection assay was performed to date infection in mbds (recent: < months). a partial transmission network was computed based on tamura-nei nucleotidic distance (threshold for hiv- s/t b = . %; for non-b s/ t = . %) and assortative mixing was evaluated for mbds epidemiological data, including risk factors for hiv infection (msm, hts, others and unknown). selfreported data were then compared to assortativity-enhanced data. results: hiv- strains from mbds and pcs were linked into clusters including at least one mbd. primo-only clusters were excluded from the analysis. compared to mbds who did not cluster, those found linked to the network were younger ( vs. year-old; p < . ) and were more likely to have a recent infection ( % vs. %; p = . ). assortative mixing indexes showed that paired individuals were more likely to live in the same area (p < . ) and to have the same risk factor for hiv infection (p < . ) compared to a random distribution. imputing msm risk factor to non-msm individuals paired with msm changed the distribution of risk factors as follows: msm: % vs. %, hts: % vs. %, other: % vs. % and unknown: vs. %. summary/conclusions: after validating the assortativity of risk factors between paired individuals, and imputing msm risk factor to individuals self-reported as non-msm (including those with no identified risk factor), up to % ( / ) of mbds could be reclassified as msm. this is a worst-case scenario, as the network analysis does not exclude the possibility of one or several persons between two paired individuals (missing link). altogether, these results could help reevaluate the hiv residual risk linked to msm mbds, especially in the frame of the evolution of blood donor deferral criteria. background: although most individuals remain asymptomatic, htlv infection can lead to adult t-cell leukaemia/lymphoma (atll) and htlv- associated myelopathy (ham). the serious nature of these diseases, evidence of transmission via non-leucodepleted blood, and concern about a high prevalence among donors originating from endemic areas led to the uk blood services introducing universal blood donation screening in . monitoring through routine surveillance commenced and htlvinfected donors were invited to participate in the htlv national register cohort study to assess disease progression. these data together with evidence from lookback to previously untested donations and cost-effectiveness analysis were reviewed by an expert working group in and . aims: to describe the epidemiology of htlv among uk blood donors and evidence of disease progression from long term follow up of asymptomatic donors. methods: uk blood donations screened, and infected donors identified are reported to a national surveillance scheme. these donors are contacted, their results explained and information about clinical history and possible sources of infection are collected. where appropriate, htlv-infected donors are consented to the register, with participants completing a baseline questionnaire about their health, flagged in registries for cancer or death, and followed up about every - years. results: in the uk - , htlv-infected donors were identified. prevalence among new donors was steady around / donations. prevalence among repeat donors peaked in ( . / donations), with most in previously untested. from to , prevalence of . per , donations (average of one positive/year) was recorded. in , prevalence among new donors increased to . / , donations ( positives), with increased numbers associated with asian ethnicity and coinciding with an increase in collections from bame groups. overall, most were women ( / , %), uk-born ( / ; %) and htlv- infections ( / ; %). mean age was years. almost all positive donations were from previously untested donors ( / ), with seroconversion within a year of previous donation confirmed for only of the previously tested donors. typically, infections were associated with endemic countries (including caribbean region, west africa, iran, india and japan), acquired through breast feeding or from their heterosexual partner originating from these countries. interestingly, three were thought to have been infected through self-flagellation. a total of htlv-positive asymptomatic blood donors have already been recruited to the htlv national register, and during over -person years follow-up, none had developed atll or ham. summary/conclusions: over years of testing, few seroconverters were identified, suggesting very little ongoing transmission among uk blood donors. the lack of disease among the cohort study was also reassuring, although it is likely too early to detect associated symptoms of a slow progressing disease. recruitment to this unique dataset continues, also outside of the blood donation setting. as a result of these surveillance data, evidence from lookback, and cost-effective analysis, in nhsbt ceased to test donations from previously tested donors unless the donation was being used to manufacture a non-leucodepleted component. finland lies in northern europe between the °and °n latitude. the length of the country is km and width km. by surface area it is the fifth largest country in eu. the population of the country is . million resulting in the lowest population density in eu ( . inhabitants/km ). the whole country is inhabited, although most of the population is packed in the south. the climate of finland is influenced mainly by its latitude, but the warm waters of the gulf stream and the north atlantic drift current also play a role. due to finland's northern location, winter is the longest season. the southern portions of the country are snow-covered about three or four months of the year, and the northern regions for about seven months. long distances, low population density and the extreme climate give logistical challenges. it is estimated that these logistical costs can be as much as - % of gdp in finland. the finnish red cross blood service (frc bs) has been the nationwide blood service provider in finland since . frc bs collects annually about whole blood units of which % are collected in fixed sites and % in mobile sessions around the country. central activities (donor recruitment, medical support, production, testing, supply chain management, digital services and administration) are located in helsinki. management of transfusion is highly dependent on the logistical arrangements from blood donation sites to the central facilities and from the central inventory to the hospitals. the logistics is outsourced to three major partners all of whom have their roots in nationwide public transportation and logistics services. posti ltd is a state owned company having its roots in the national postal and telecom office. today it is the leading postal and logistics service company having the widest network coverage in finland. blood units collected at different fixed sites and mobile sessions are transported overnight by posti ltd to the frc bs central facilities by am on the day following the blood donation. posti ltd is also used for the regular deliveries of blood products to the hospitals. the other important partner is matkahuolto ltd, which was founded in the s to maintain bus stations and to serve as a common marketing company for the bus and coach services in finland. it maintains a nation-wide package delivery system based on the scheduled bus route network. matkahuolto ltd is used to transport donor testing samples from the donation sites to the central laboratory. by this arrangement it is possible to obtain most of the donor samples to the laboratory around midnight, which significantly speeds up the completion of laboratory results. the third logistics partner is jetpak finland ltd, which operates the air freight for the national flight company finnair. blood transfusion services can be managed centrally in a large sparsely populated country in a manner that is of high quality, safe and cost effective. however, the supply chain has to be planned carefully. background: elearning is a divisive topic. it is often criticised as an inferior form of education while simultaneously being promoted as a means to provide education to large numbers of people in a consistent, cost-effective manner. bloodsafe elearning australia (bea) is a government-funded blood transfusion education program that commenced in and provides courses in clinical transfusion practice and patient blood management (pbm) including: -clinical transfusion practice ( courses) -pbm: general ( courses) -pbm: medical ( courses) -pbm: acute care and surgical ( courses) -pbm: obstetrics and maternity ( courses) -pbm: neonates and paediatrics ( courses) aims: to determine the engagement, outcomes and impact of learning of bloodsafe elearning australia courses. methods: a retrospective analysis of user registrations, course completion records, course evaluation data and red cell usage in australia to determine learner demographics, and the impact on acquisition of knowledge and application to clinical practice. results: in the period from july to january : - , people registered as learners - , , courses were completed -these learners came from countries, with , ( . %) of them from outside of australia. analysis by profession shows that: - . % are nurses and/or midwives - . % are medical - . % are laboratory, anaesthetic technicians or other. analysis of user evaluation data (n = , ) from april to january shows that these courses have a positive impact, with . % of respondents stating they gained additional knowledge, . % able to make changes to clinical practice, and . % reporting that these changes will improve patient safety and outcomes. analysis of international participants shows greater benefits with . % gaining knowledge, . % able to change their clinical practice and . % believing this will improve patient outcomes. analysis of red cell usage in australia shows that since there has been a . % reduction in red cells issued. this has been achieved through a number of pbm activities including development of guidelines, research and audits, education, waste reduction strategies, and promotional campaigns. bloodsafe elearning australia courses on pbm were released in and are one part of this pbm activity, and it is notable that these courses have the widest reach as they are undertaken by a large proportion of doctors, nurses and midwives in australia who are not directly involved with the blood sector. stakeholder feedback shows that the program provides credible, consistent education that is cost-effective, reduces duplication, is 'best-practice' elearning, is readily accessible, and allows institutions to focus on the development of practical transfusion skills. summary/conclusions: this analysis shows that elearning is a well-accepted, wellutilised form of education for healthcare workers to learn about clinical transfusion practice and patient blood management, and learners gain knowledge that can change their clinical practice and improve patient outcomes. it is also likely that these courses have contributed to better utilisation of a scarce, freely-donated resource. this approach has global reach and availability, and is a cost-effective model for improving transfusion practice in the developing world by providing education for millions of healthcare workers. d-s - prospective platelet auditing: analysis of trainee compliance with guidelines pathology, columbia university, new york, united states background: apheresis platelets are a component product with high cost and limited supply. furthermore, there is a potential for severe transfusion reactions associated with this product such as transfusion related lung injury (trali), and sepsis due to bacterial contamination. therefore, transfusion guideline compliance is closely monitored by many centers. this quality assurance analysis describes our experience with prospective platelet auditing performed by physicians in pathology residency training. aims: this study aims to evaluate the ability of physicians in training to perform prospective auditing and compare policy compliance for different levels of experience. methods: this is a quality assurance analysis of a prospective platelet audit program for a -month period (january -december ). the blood bank paged the on call physician any time an order was placed for a patient with a platelet count of > , /ll, ≥ doses of platelets with no interim repeat count, or an unknown platelet count. audit records created by physician trainees in their first post graduate year (pgy ) were compared to subsequent years (pgy > ). information collected included the total number of doses requiring approval, number of products approved, training year for the approving physician, and transfusion indication. cost analyses assumed $ for a dose of platelets. descriptive statistics and comparative analysis using a pearson's chi-square were used with a difference of p < . considered statistically significant. results: there were platelet doses requiring approval with ( %) routed to the pgy group and ( %) to the pgy > group. there were ( %) ordered doses that were in compliance with hospital transfusion policy and ( %) that were not in compliance with hospital policy. of the appropriately ordered doses, the pgy group declined release of necessitating the clinical team to insist upon release without approval, and there were zero such instances in the pgy > group. when paged by the blood bank, pgy physicians approved product release not in compliance with policy for / ( %) doses while pgy > physicians approved not indicated products for / ( %) of doses (p < . ). products not indicated by hospital policy were held from release by pgy physicians for / ( %) doses and / ( %) doses by pgy > physicians (p < . ). the ordered doses not in compliance with hospital policy had an estimated cost of $ , . of this cost, there was a calculated $ , savings of products not released due to prospective auditing. there was an additional potential savings of $ , for products not indicated but released ($ , from the pgy and $ , from the pgy > group). summary/conclusions: despite a higher number of requests being routed to the more senior pgy > group, there were a disproportionately higher number of out of compliance platelet orders being released by the pgy group in addition to withholding needed products on several occasions. potential mitigation strategies for this could include a closer level of oversight for pgy physicians, and the potential monetary savings could justify a hiring a dedicated patient blood management team or quality assurance manager to monitor compliance and provide feedback to clinicians. d-s - what can we learn from how adverse events are detected? norwegian directorate of health, oslo, norway background: the primary aim of reporting systems, such as haemovigilance systems, should be learning and improvement and to identify risk areas, not simply counting errors. to understand and learn from adverse events the description of how, where and why they occur, and how they are detected, is important. to support our understanding, we use a predetermined classification that is required for reporting to eu, supplemented by classification suggested by ihn, who and ourselves. in we started asking the blood establishments what steps they would take to prevent recurrence of the event, and we added a simple classification to tell how the adverse event had been detected. aims: this study aims to analyze how different types of adverse events reported to the haemovigilance system were detected, whether the current quality management systems used in norwegian blood establishments had effective barriers and whether new barriers should be considered. methods: adverse events reported to the norwegian haemovigilance system in and were analyzed with focus on how the adverse event had been detected. in all cases classification had been performed by the reporter of adverse events and were confirmed, or reclassified if necessary, by the haemovigilance team before analysis. for analysis based on classification we used powerbi (microsoft). results: a total of adverse events were reported from norwegian blood establishments. all had been classified according to how the adverse event had been detected. twenty ( . %) adverse events were detected because of alarms or warnings from it-systems or equipment. routine checks by blood establishment staff detected ( . %) events and formal internal or external reviews detected one event. seven ( . %) events were detected because the donor became ill shortly after donation, but the illness was not caused by the donation. sixty-four percent of events were detected in a way that did not fit our present classification and hence were classified as "other". twelve out of wrong blood in tube were detected by an alarm from the it-system or routine check, as were six of events related to blood ordering, two of seven errors in testing, six of events where incorrect blood had been transfused, and eight of events related to donor selection. in reports human error was listed as the cause of the event and of these were detected by alarms or routine checks. summary/conclusions: detection of adverse events by alarms or routine checks are highly efficient when the blood establishment has historic data to check against, as exemplified with wrong blood in tube or a patient require irradiated blood components. when no historical data exists or when the quality management systems do not require routine checks, events are usually detected by chance. further analysis is needed to see if and where the quality management systems should be improved. the wide variety of adverse events can make it difficult to select which area to prioritize in the improvement work. results: the hb measurements from the finger prick were on average . g/l ( . %) higher than from the venous blood samples. the range of the difference was - -+ g/l. these results were used in order to add novel information to determine the measuring uncertainty of hb measurement in frcbs. in . % ( / ) of the donors in this study the venous hemoglobin measurements were below the cut-off point of donor eligibility. in those measurements the difference of the finger prick and venous hemoglobin measurement was at most + g/l. % of the hemoglobin results from the finger prick were in the range ae g/l compared to the venous hemoglobin results. % of the results from the finger prick were between ae g/l (the precision of the device) compared to venous hemoglobin results. in cases the difference between finger prick and venous measurements was outside standard deviations from the mean i.e. . % from the bottom (n = ) or top (n = ) of distribution. systematic errors were seen in some nurse's results both towards too low or too high hb result in the finger prick measurement and some nurses had random errors in both directions. the batch of cuvettes, donors' age, gender or the time of sampling were not detected to have an impact on the difference between finger prick and venous hb measurements in this study. summary/conclusions: the results of the poc measurements compared to the cell counter were in agreement with published data and with manufacturers' information on the device. the practical skill test is a workable way to develop competence and operations to measure the hemoglobin from the finger prick. it offers an opportunity to give personal feedback to nurses concerning their personal performance in the use of the current hb measurement technic. it also provided data on the accuracy of the poc method in the everyday donor selection process. background: whole blood donation has frequently been related to iron deficiency. a blood donor loses per donation about % (men) to % (menstruating women) of iron stores. to replenish the iron lost by blood donation in a donation interval of days, a donor needs to absorb . mg iron per day. this amount exceeds the reported maximal amount of absorbed iron of - mg/day, eventually leading to iron deficiency, with consequences such as donor deferral and possibly iron deficiency-related symptoms (decreased physical endurance, fatigue, pica, restless legs syndrome, and cognitive functions). since hb levels do not reflect donors' true iron status, measuring ferritin is a better way to detect low iron stores in whole blood donors. studies from usa and denmark showed that on the introduction of ferritin measurement with either extension of donation intervals or iron supplementation in case of low iron stores, deferral percentages for low hb declined in both male and female donors. aims: to gain more insight in iron status of whole blood donors during their donor career, how this affects donor health and which measures may prevent low iron stores in donors. methods: in the netherlands, sanquin blood bank is currently implementing a policy with ferritin-guided donation intervals. in brief, ferritin levels are measured in all new donors and in repeat donors every th donation or in case of an hb below the deferral threshold. donation intervals are extended if ferritin levels are < lg/ l, or ≥ and ≤ lg/l (for and months respectively). we anticipate that routine ferritin measurement will ultimately result in a lower prevalence of iron deficiency, less hb deferrals and improved donor retention. this will be further evaluated in a stepped wedge cluster-randomized trial 'find'em', which may also identify subgroups of donors prone to develop (symptoms of) iron deficiency. in addition, implementing ferritin screening may lead to a decreased donor availability. for this purpose, we modeled the impact of the implementation of our ferritin deferral policy on donor availability over time, which provides insight for both the expected size of the impact of the ferritin deferral policy and the time and rate at which this impact is expected to occur. this allows the blood bank to timely plan actions to counterbalance possible donor shortage and ensure an adequate blood supply. lastly, iron supplementation can be an alternative measure instead of donation deferral. as the used and recommended dosage of iron supplementation varies widely across blood services, sanquin is planning to start a new study in whole blood donors to gain evidence on the dosage and frequency of iron supplementation and its effect on ferritin and hemoglobin levels and donor health. results: the before-mentioned studies are ongoing and results will be expected from onwards. summary/conclusions: iron deficiency is a frequent side effect of whole blood donation. to prevent iron deficiency and its consequences, like donation deferral and health issues, more evidence-based insight in iron management of whole blood donors is being generated. d-s - superdonors -genetic risk profile and risk of low hemoglobin deferral background: no reliable method exists for stratifying new blood donors into those who can maintain sufficient hemoglobin (hb) levels and those who will be deferred because of a low hb (< . mmol/l [< . g/dl] for women and < . mmol/l [< . g/dl] for men). polygenic risk scores (prss) have shown great promise in predicting complex disease risk. prss could also prove useful for identification of donors genetically predisposed to low hb levels, and, thus, to an increased risk of deferral. aims: the objective of the study was to evaluate the association between prs (modelled to predict hb level as a quantitative trait) and risk of deferral as a binary outcome. methods: the danish blood donor study (dbds) is an ongoing nationwide blood donor cohort since with more than , participants. extensive genotyping has been performed on approximately , dbds participants using the infinium global screening array (illumina â ) and extended by use of imputing based on the pan-scandinavian reference genome. based on hb and genetic data on more than , icelandic individuals (an independent discovery cohort), we constructed different weighted prss for individuals from dbds. information on the donors' whole blood donations following inclusion into dbds unto end of was obtained from a nationwide donation database, scandat. the best predictor of hb among the nine prss was chosen and used in all subsequent analyses. we performed multilevel mixed-effects linear regression analysis with hb as outcome, and prs as factorized explanatory variable with cutoffs at , , , , , , , and th percentiles, respectively. moreover, the models had a two-level clustering on donor id and donation site and an id-specific random intercept; and further adjusted for: sex(binary), age(continuous), year of donation(factorized), and time since last donation (continuous). lastly, risk of deferral was evaluated in random effects logit models with similar covariables and clustering structure. results: mean number of donations per donor after dbds inclusion was . donations. generally, we observed a statistically significant positive association between prs(hb) and current hb levels. compared with donors in the - prs percentile group, donors below the th percentile had lower (- . hb mmol/l ( % ci: - . ; - . )) and donors above the th percentile higher (+ . hb mmol/l ( % ci: . ; . ) hb levels. in the random effects logit models we observed a marked increase in deferral risk with decreasing prs percentile strata. with the - prs percentile stratum as reference, donors below the th percentile and donors above the th percentile had odds ratios of deferral of or = . ( % ci: . ; . ) and or = . ( % ci: . ; . ), respectively. summary/conclusions: we found a statistically significant positive association between prs(hb) and hb levels and a markedly increased risk of deferral with decreasing prs(hb). from a scientific point of view, it is unsurprising that a genetic score for hb from an independent cohort is associated with hb in another cohort. however, from a practical perspective, prss may be the first step in a personalized donation approach to donors and their risk of deferral. background: individually calibrated inter-donation intervals for repeat blood donors have the potential to minimize the risk of iron related adverse outcomes (e.g., hemoglobin deferral or collecting a donation from a donor with low or absent iron stores) without unduly impacting the donated blood supply. machine learning has shown promise for personalized clinical risk assessment. aims: our aim is to use machine learning to develop donor-specific, personalized inter-donation intervals that minimize the risk of adverse outcomes while maintaining or improving the adequacy of the donated blood supply. methods: using a public use dataset from the reds-ii donor iron status evaluation (rise) study (cable, transfusion, ) we defined donor profiles with physiological measures including hemoglobin, ferritin and soluble transferrin receptor along with questionnaire responses regarding diet, reproductive health indicators, and demographics. we used these profiles ( features, , donations from , repeat donors) and the time until the next donation attempt to predict iron-related outcomes of the next donation attempt. possible outcomes were no adverse outcome, hemoglobin deferral, low-iron donation (ferritin < ng/ml for women and < ng/ml for men), or absent-iron donation (ferritin < ng/ml for men and women). we trained multiple machine learning models on , of the donations and selected the model with the best performance (lowest cross-entropy loss in cross validation). we assessed the best model's performance on a hold-out test set of donations, which were not used to train or select the model. we then used our model to generate risk estimates for these test donors as a function of days since their last donation, which varied from days to days. to show individual variation, we generated graphical representations of individual donors' risk over time. results: ferritin, log ferritin, body iron, and time since last donation were most useful for predicting iron-related adverse outcomes at the next donation attempt. the estimated risk of adverse outcomes at the next donation attempt varied considerably across donors. as expected, the risk of adverse outcomes days after the last donation was lower than the risk days after the last donation for most donors (risk of hemoglobin deferral decreased for % of donors; risk for low-iron donation decreased for %; and risk for absent-iron donation decreased for %). summary/conclusions: the risk of iron-related adverse outcomes as a function of time since last donation varies considerably between donors. machine learning models trained on relevant donor profiles can effectively estimate how an individual's risk will change over time. individual risk estimates could allow blood centers to protect highrisk repeat donors while continuing to allow more frequent collections from low-risk donors. further study is needed to ensure this approach works well for donor classes that are not well-represented by the rise dataset, to assess risk prediction outside of the physiological measures collected in the rise study, and to determine the viability of assigning an optimal inter-donation interval to a first-time donor using this approach. background: iron depletion is common among repeat blood donors, who contribute a large proportion of the blood supply in many countries. exogenous iron from multivitamins with iron or iron-only supplements helps prevent donation-induced iron depletion, but whether dietary iron protects against iron depletion in repeat donors has not been rigorously evaluated. available data from the reds-ii rise study in the us (cable, transfusion, ) and from the danish blood donor study (rigas, transfusion, ) suggest minor impact of dietary iron consumption on blood donor iron status in multivariable regression models. both studies, however, analyzed food items singly, such as beef or fish, rather than in aggregate, so precision was limited. aims: to evaluate whether a composite measure of dietary heme iron consumption, weighted for frequency and iron content, was associated with incident iron depletion among repeat blood donors. methods: a re-analysis of the rise cohort was undertaken to test the hypothesis that reported levels of animal protein consumption was associated with lower risk for incident iron depletion among repeat blood donors. the six blood centers participating in rise enrolled first-time and frequent donors for - month follow-up of donation frequency and iron status. a brief checklist of food categories was administered at baseline to assess frequency of consumption of several categories of animal protein that are rich in heme iron, the biochemical form of iron most readily absorbed. an iron composite score (ics) weighted for frequency and heme iron content was derived and subjects were grouped into tertiles (thirds) of ics. iron status was assayed at enrollment and study completion and at roughly one-third of donation visits in between. modified poisson regression with generalized estimating equations was used to generate risk ratios controlling for donation frequency and other covariates. results: of enrolled donors, were iron replete at baseline and completed the food checklist. the median value of the ics for each tertile (lowest to highest) was . , . , and . mg of heme iron weekly. these values are equivalent to approximately , , and servings of beef per week, or alternately twice as many servings of chicken or pork. across follow-up visits with iron outcomes assayed, almost % of donor visits were associated with intermediate iron depletion (serum ferritin < ng/ml) and . % with complete depletion of iron stores, representing serum ferritin < ng/ml. after controlling for demographic factors and donation frequency, the lowest tertile of ics was associated with a greater than fold higher risk for complete iron depletion during all follow-up visits (rr . , % ci . , . , compared to the highest tertile). summary/conclusions: in this longitudinal evaluation of dietary iron and iron status, blood donors with low intake of heme iron had an elevated risk for developing advanced iron depletion. these results suggest that blood centers should continue to recommend iron-rich diets to repeat blood donors. background: blood donors lose approximately mg of iron with every blood donation. as a result, frequent blood donors are at risk of iron deficiency and low hemoglobin (hb) levels, which may affect their health and eligibility to donate. lifestyle behaviors such as dietary iron intake and physical activity, may influence iron stores and thereby hb levels. gaining insight into associations between lifestyle behaviors and hb levels is valuable for blood supply organizations, as lifestyle behaviors can potentially be considered to prevent hb deferrals. examining the mediating role of ferritin, a measure reflecting iron stores, in these associations will help to gain insight into whether iron stores could be the limiting or enabling factor that links lifestyle behaviors to hb recovery after donation. aims: to investigate associations between lifestyle behaviors (dietary heme and non-heme iron intake and physical activity) and hb levels, and whether ferritin mediates these associations. methods: donor insight-iii (dis-iii) is a dutch cohort study of blood and plasma donors and included , donors. participants who were pregnant, had hemochromatosis, used iron supplements/medication, got a hysterectomy or bilateral oophorectomy were excluded (n = ). hb levels were measured in edta whole blood samples using a hematology analyzer (xt- , sysmex, japan) and ferritin was measured in plasma from lithium heparin tubes (architect ci , abbott laboratories, u.s.a.). dietary heme and non-heme iron intake (grams/day) were assessed using a food frequency questionnaire adapted to measure iron intake. moderate-tovigorous physical activity (mvpa, minutes/day) was assessed using the international physical activity questionnaire (ipaq)-short form. results: in total, , ( , female) participants were included. donors with higher intakes of heme iron had significantly higher hb levels (regression coefficient (b) ( % confidence interval ( % ci)) in men and women respectively: . ( . to . ) and . ( . to . ) mmol/l), independent of age, smoking, menstruation, number of donations in previous two years, donation interval, sedentary behavior, the other lifestyle variable (i.e. (non-)heme iron intake or mvpa), and initial hb level. non-heme iron intake was negatively associated with hb levels (- . (- . to - . ) and - . (- . to - . ) mmol/l for men and women respectively). ferritin mediated associations between dietary iron intake and hb levels (indirect effect in men and women respectively: . ( . to . ) and . ( . to . ) lg/l for heme and - . (- . to . ) and - . (- . to - . ) for non-heme). more mvpa was negatively associated with hb levels in men only (- . (- . to - . )), which was not mediated by ferritin. summary/conclusions: in conclusion, higher heme and lower non-heme iron consumption are associated with higher hb levels in donors via higher ferritin levels, indicating that donors with high heme iron consumption may be more capable of maintaining iron stores to recover hb levels after blood donation. more mvpa was associated with lower hb levels, although effect sizes were small, independent of ferritin. taking a donor's lifestyle behaviors into account may be useful in preventing low hb levels in blood donors. immune thrombocytopenia (itp) is still diagnosed by exclusion of other causes for thrombocytopenia. sensitive and specific detection of platelet autoantibodies may support the clinical diagnosis and prevent misdiagnosis of itp. for example, the direct monoclonal antibody immobilization of platelet antigens (maipa) assay, performed with in vivo sensitized patient platelets, offers platelet glycoprotein specific autoantibody detection with high accuracy. a drawback is that low platelet counts demand a large blood sample to have sufficient patient platelets available for analysis. circulating platelet autoantibodies are more difficult to detect by maipa; and may demand more sensitive detection platforms, such as those using surface plasmon resonance. in general, the presence of anti-gpiib/iiia, anti-gpib/ix and anti-gpv platelet autoantibodies is investigated. all these antibody specificities have been found in patients with itp. in itp, platelet autoantibody-mediated destruction via the spleen has been proposed; but also other mechanisms leading to low platelet counts in itp may play a role. inhibition of megakaryocytopoiesis by autoantibodies or by t cells has been suggested. in mice, gpib-directed antibodies induce loss of platelet-sugar epitopes, inducing hepatocyte-medicated platelet destruction. platelet autoantibodies can cause complement activation, which may contribute to platelet autoantibodymediated destruction. interestingly, we recently found that lack of detectable platelet autoantibodies is correlated with non-responsiveness to rituximab (cd moab) treatment in itp patients. in children with newly diagnosed and often transient itp, platelet autoantibodies of igg class or not often found, but of igm class are present for short duration. in conclusion, testing for platelet autoantibody characteristics and their pathologic effect may be helpful in establishing the diagnosis of itp and in choosing the best individualized therapy for itp patients. a-s - thrombopoietin receptor agonist (tpo-ra) treatment raises platelet counts and induces immunomodulation in immune thrombocytopenia (itp) jw semple , r aslam , e speck , j rebetz and r kapur lund university, lund, sweden st. michael's hospital, toronto, canada background: itp is an autoimmune bleeding disorder in which autoantibodies and/ or autoreactive t cells target the destruction of platelets and megakaryocytes in the spleen and bone marrow. several therapeutic options e.g. corticosteroids, intravenous immunoglobulins (ivig), rituximab and splenectomy are available for patients but inadequate efficacy, side effects and/or expense can make them undesirable. for the last years, tpo-ra e.g. romiplostim and eltrombopag have made a substantial contribution to the treatment of itp patient's refractory to first-line treatments. of interest, approximately % of patients that are tapered from tpo-ra therapy show a sustained response (e.g. a stable higher platelet count than before treatment). the mechanism of how tpo-ra induce these sustained responses is unknown. aims: to analyze the efficacy and immunomodulatory properties of a murine tpo-ra (amp , amgen) in a well-established murine model of itp that demonstrates both antibody-and t cell-mediated thrombocytopenia (chow l et al., blood ) . methods: platelet glycoprotein (gp) iiia (cd ) knockout (ko) mice were immunized with cd + platelets and itp was initiated by the transfer of their splenocytes into mice with severe combined immunodeficiency (scid). the scid mice were treated with either placebo or tpo-ra weekly and platelet counts and serum anti-platelet antibodies were measured weekly. results: in an initial pilot dose escalation study, control na€ ıve scid mice treated with a single subcutaneous bolus of different concentrations of murine tpo-ra ( , and ug/kg) had significantly higher platelet counts by h post infusion. in addition, compared with untreated mice, bone marrow histology revealed significantly increased numbers of megakaryocytes. maximal platelet count increases were observed with the highest tpo-ra dose and this dose was chosen to treat scid mice suffering from itp. when scid mice were treated with weekly injections of tpo-ra, platelet counts began to increase after weeks and were fully rescued to control levels after weeks post splenocyte transfer. of interest, compared with non-treated itp mice, serum igg anti-platelet antibody production in the tpo-treated mice was significantly reduced starting from two weeks post splenocyte infusion. summary/conclusions: these results suggest that murine tpo-ra is not only an efficacious therapy for murine itp but also induces immunomodulation indicative of immunosuppression. thus, this model may be able to elucidate the mechanism of how tpo-ra's induced immunosuppression in patients with itp. background: desialylation, the loss of sialic acid content on platelets (plts) glycoproteins (gps) was recently identified to contribute in immune thrombocytopenia (itp). however, the potential impact of autoantibodies (aabs) on megakaryocyte sialylation remains unclear. aims: to investigate the effect of itp aabs on plts and megakaryocytes (mks) sialylation and the subsequent impact on plt survival. methods: aabs from well-characterised itp patients induced gp-modifications were tested using a lectin binding assay. after incubation of mks or plts with itp or control sera, glycan changes were analysed by flow cytometry (fc). to investigate the impact of desialylation on plts life-span, the nod/scid mouse model was used. results: itp sera were investigated in this study. ( %) sera induced a significant increase in rca signal on plt surface compared to control sera from healthy donors (rca-mean fold increase (rca-fi): . , range: . - . , p = . ). in addition, ( %) sera caused higher ecl binding to test plts (ecl-fi: . , range: . - . , p = . ). injection of desialylating aabs resulted in accelerated clearance of human plts from the circulation of the nod/scid mice which was significantly reduced by a specific neuraminidase inhibitor that prevents background: autoimmune hemolytic anemia (aiha) is a rare autoimmune disease characterised by hemolysis associated with the presence of immunoglobulins (igg, igm, or iga) and/or components of complement system on red blood cells (rbcs), which is usually demonstrated by a positive direct antiglobulin test (dat). depending on the presence of an underlying disorder, aiha can be subdivided into primary and secondary and, by the temperature at which autoantibodies bind optimally to rbcs, into warm antibody aiha (waiha), mixed aiha (including both warm igg and cold igm antibodies), cold agglutinin disease (cad), paroxysmal cold hemoglobinuria (pch) and dat negative aiha. a frequent finding in immunohematology is the presence autoantibodies on rbcs without clinical symptoms of hemolysis that may later develop. aims: the aim of this study was to analyse serologic findings and transfusion support in patients with aiha and also to analyse dat positive patients without clinical symptoms. methods: we included data for all adult patients with aiha and dat positive patients without clinical symptoms diagnosed and/or treated at the university hospital centre (uhc) zagreb, croatia in the period between and . the diagnosis of aiha was defined by anemia with features of hemolysis (elevated bilirubin and/ or elevated lactate dehydrogenase and/or low haptoglobin level) and a positive dat. results: the data from patients ( % women) meeting the inclusion criteria was analysed. the mean age at the time of aiha was years (range - years). the mean hg level at diagnosis was . g/l. dat results were positive mostly with igg+c d ( %) or igg ( %). most patients had warm aiha ( %). other types of aiha diagnosed were mixed aiha ( %), cad ( %), pch ( . %) and dat negative aiha ( . %). in cases alloantibodies were detected with autoantibodies in the patient's plasma. patients were treated with corticosteroids as st line therapy and some with intravenous immunoglobulins (ivig). in severe or refractory patients rituximab and/or splenectomy was applied. a total of % of patients were transfused at a mean hemoglobin level of . g/l. during this period we detected dat positive patients without clinical symptoms. summary/conclusions: most patients from our study were diagnosed with warm type of aiha, followed by mixed type aiha and cad. on the other hand, pch and dat negative aiha were very rare, which is in concordance with relevant literature. most patients were transfused despite therapy used, which is not desirable in patients with aiha and should be better controlled, especially in moderate cases of anemias, where this is rarely necessary. a significant number of patients that were dat positive without clinical symptoms may later develop aiha and should be closely monitored. background: autoimmune haemolytic anaemia (aiha) is a decompensated acquired haemolysis caused by the host's immune system acting against its own red cell antigens. aiha is a rare disorder and although british society of haematology (bsh) guidelines for diagnosis and treatment were published in february , there is little evidence for clinical practice in the united kingdom. aims: to investigate the approach to diagnosis, investigation and management of patients with aiha in english nhs trusts. methods: a survey of diagnostic and management practice was designed, piloted and disseminated to clinical transfusion leads in all english acute nhs trusts from november to march . completion was by a consultant haematologist treating patients with aiha but a response that represented a departmental consensus was encouraged. results: responses represented % ( / ) of english acute trusts. median number of adults with aiha diagnosed annually was - . in the preceding years, % ( / ) recalled at least one patient who had died due to aiha. although % ( / ) undertook a bone marrow biopsy in all patients, % required additional features, mainly: neoplasia, age over or being treatment-refractory. for patients with suspected drug-induced immune haemolysis, % ( / ) would not organise confirmatory tests, either because it was considered unnecessary ( / ), or because clinicians were unsure how to access tests ( / ). when determining aiha subtype, % ( / ) indicated there were no circumstances in which they would undertake cold antibody testing (antibody titre and/or thermal amplitude), with considering this unnecessary and unsure how to access tests. in clinical scenarios of patients with aiha and dat positive to c d ae igg ae cold associated symptoms, up to % ( / ) of respondents would not test for cold antibodies. for first line treatment of primary warm aiha, mean duration of prednisolone mg/kg given before judging the patient refractory and reducing the dose was . weeks (sd . , range - weeks). second line treatment of choice was rituximab for % ( / ) of respondents and splenectomy for %. intravenous immunoglobulin and splenectomy were the most cited rescue therapies. for primary cold haemagglutinin disease (chad), first line treatment was rituximab-based for % ( / ) but single agent steroid for %. we also explored the potential for future audit and research. % ( / ) of respondents were able to identify patients with aiha who previously required transfusion. % ( / ) of respondents would consider supporting a registry of patients with aiha requiring transfusion. the key questions that respondents thought a registry should address were: morbidity and mortality, treatment response, and differences in the diagnosis and treatment of aiha subtypes. there was uncertainty over access to cold and drug-induced antibody tests and clinicians do not always conduct bshrecommended cold antibody tests for aiha with c d positive dat. initial treatment of primary warm aiha and chad broadly matched bsh guidelines although % ( / ) would continue prednisolone at mg/kg beyond the recommended days before starting a taper, with greater toxicity risk. summary/conclusions: the findings support the need for a range of research initiatives, including creation of an aiha registry. preoperative anemia is common and is associated with adverse outcomes in the peri-operative period. preoperative anemia also increases the risk of allogeneic blood transfusions, which may lead to increased perioperative mortality, increased hospital length of stay and infections. diagnosis and treatment of anemia is one of the tenets of patient blood management (pbm), along with reduction in unnecessary transfusions and diagnostic phlebotomy, as well as use of hemostatic agents to reduce bleeding among many others. effective pbm is multi-disciplinary, multi-modal, timely, individualized and patient-centered. early referral to pbm and multi-modal pbm interventions are associated with greater improvement in pre-operative hemoglobin. pbm has been shown to reduce transfusions and cost, while system-wide, multi-modal programs may also be associated with improvement in mortality. using examples from our local research and practice, i will discuss three aspects of pbm. iron and erythropoiesis stimulating agents (esa) are effective, safe and used extensively in management of pre-operative anemia. previous studies have questioned whether esa leads to increased risk of thrombosis, however, recent systematic reviews do not support these concerns. another pbm approach is to reduce bleeding during surgery by using hemostatic agents such as tranexamic acid (txa). txa reduces transfusion requirements in knee and hip arthroplasty, and is safe, widely available and relatively cheap. txa is effective in both anemic and non-anemic patients, making it an attractive universal pbm strategy. finally, recommendations and evidence-based guidelines on pbm exist, including the most recent international guidelines developed by the pbm international consensus conference. however, knowledge translation in pbm has been a problem and a number of barriers to its implementation have been identified. these include perceived or actual lack of expertise, time, and resources, as well as lack of physician and patient engagement. one way to address patient engagement is education through character driven animation and we are currently trying this approach. a-s - low vs . high hemoglobin trigger for transfusion in vascular surgery (tv): a randomized clinical feasibility trial (the tv trial) background: current guidelines advocate to limit red-cell transfusion during surgery, but the feasibility and safety of such strategy remains unclear as the majority of evidence is based on postoperative stable patients. aims: we assessed the effects of a protocol aiming to restrict red-cell transfusion during elective vascular surgery. methods: fifty-eight patients scheduled for lower limb-bypass or open surgery of abdominal aortic aneurysm were randomized to a low-trigger (hemoglobin < . g/ dl, mmol/l) vs. high-trigger (hemoglobin < . g/dl, mmol/l) for red-cell transfusion throughout hospitalization. intraoperative change in cerebral-and muscle tissue oxygenation was assessed by near-infrared spectroscopy. we used a nationwide registry to collect data on death and major cardiovascular events, which encompassed ( ) severe adverse transfusion reaction, ( ) acute myocardial infarction, ( ) stroke, ( ) new-onset renal replacement therapy, ( ) vascular reoperation, and ( ) amputation of the lower limb. results: the primary outcome, mean hemoglobin within days of surgery, was significantly lower in the low-trigger group: . g/dl vs. . g/dl in the hightrigger group (mean difference . g/dl; p = . , longitudinal analysis) as were units of red-cells transfused ( background: controlled non-hemato-oncological studies have consistently demonstrated a single-unit red blood cell (rbc) transfusion policy as well as a stringent hemoglobin (hb) rbc transfusion threshold to be safe and reduce blood product utilization. yet, it is unclear whether these conclusions also apply to the hemato-oncological patient population. aims: to quantify reduction of rbc blood product utilization by the introduction of a restrictive single-unit hb-triggered rbc transfusion policy among the inpatient hemato-oncological population. methods: under the liberal transfusion protocol, applied up till november , , standard double-unit rbc transfusion was indicated with a hb threshold ≤ . g/dl and/or anemia-related symptoms. following this date, the restrictive transfusion protocol was introduced involving a lowering of threshold to . g/dl and single-unit transfusion. for patients with an asa-score of ii-iii and iv, a hb threshold of respectively ≤ . g/dl and ≤ . g/dl applied. we evaluated rbc blood product utilization over a month period starting december , (liberal protocol) and december , (restrictive protocol) in all hemato-oncological patients admitted for chemotherapeutic treatment including hematopoietic stem cell transplantation (hsct) with an expected duration of neutropenia of ≥ days. analysis of categorical and continuous data was performed using the chi-square and mann-whitney test, respectively. results: during both observational periods, patients were admitted who in total received therapy cycles, including acute myeloid leukemia (aml) induction cycles and autologous hscts. distribution of indications of admittance, median age, duration of hospitalization and duration of neutropenia did not differ between both periods. during the restrictive period, in / ( . %) of transfusions the assigned hb trigger was adhered to. the percentage of single-unit transfusion episodes increased from / ( . %) to / ( . %) with the introduction of the restrictive protocol. overall, rbc blood product utilization per admittance did not reduce under the restrictive protocol (cumulative number of transfused rbc units . (interquartile range (iqr) . - . ) during the liberal versus . (iqr . - . ) during the restrictive period (p = . )). however, rbc blood product utilization per neutropenic day demonstrated a trend towards reduction: . (iqr . - . ) versus . (iqr . - . ) units per day during the liberal versus restrictive period, respectively (p = . ). this reduction was mainly attributed to autologous hscts during which rbc blood product utilization decreased from . (iqr . - . ) to . (iqr . - . ) units (p = . ), corresponding to a reduction from . (iqr . - . ) to . (iqr . - . ) (p = . ) units per neutropenic day. moreover, / ( . %) patients during the liberal versus / ( . %) during the restrictive period did not require rbc transfusion during admittance. consequently, stringent hb thresholds as compared to single-unit transfusions seem to more strongly impact rbc blood product utilization. summary/conclusions: a hb-triggered single-unit transfusion policy results in a strong reduction of rbc blood product utilization in the setting of autologous hsct. no utilization reduction was observed among other hemato-oncological inpatient populations receiving intensive chemotherapy. further improvement of protocol adherence rates could potentially increase the benefit of this blood saving strategy. a-s - assessment of hb content of packed red cells (prbc): is it time to label each unit with hb content? r jain , n marwaha and s sachdev transfusion medicine, aiims, new delhi transfusion medicine, pgimer, chandigarh, india background: in the current era of evidence based medicine and individualized care of patients, rbc transfusion continues to be administered on the basis of conventional wisdom and the notion of an average benefit per unit. the existing blood transfusion practice based on the "number of units transfused" ignores the fact that the total hb varies markedly among the individual rbc units. aims: the present study was aimed at estimating the hb content in packed red cell unit prepared by three different protocols from ml and ml whole blood collection in three types of blood donors: replacement blood donor (rd), first time voluntary donor (ftvd) and regular voluntary blood donor (rtvd). methods: a total of prospective blood donors were included in this study. three hundred whole blood collections were performed in each of the three groups of donors (rd, ftvd, and rtvd). within each group collections were done in double ml, triple ml and quadruple ml blood bags respectively. a pre-donation venous sample was drawn from sample collection pouch for analysis in hematology analyzer as reference method for hb concentration of donor. the hb content of packed red cell units were estimated after collection of representative sample from the blood unit. volume of prbc unit was estimated by the formula of weight of blood in prbc divided by specific gravity. the hb content in unit was estimated by the formula: hb content in unit = hb value of the prbc unit (g/dl) volume of prbc unit (dl). results: in this study the hb concentration (g/dl) was comparable among three types of blood donors except that rtvd had lower hb values when compared to rd (p = . ). hemoglobin concentration of prbc ranged from . - . g/dl; mean hb was . ae . g/dl. net hb content of prbc bag was lower in prbc prepared from rd as compared to ftvd (p = . ) and rtvd (p = . ). the hb content of prbc units prepared from ml collection ranged from . - . g and from ml collection ranged from . - . g. we observed a wide range of net hb content in the prbc units and the correlation coefficient showed the strongest association of net hb content of the prbc unit with the overall volume of prbc (r = . , p = . ).higher volume prbcs have more hb content. volume of prbc bags in the study ranged from ml to ml (including both and ml collections). summary/conclusions: the present study shows that labelling hb content of the prbc unit help in better inventory management for patients. the hb content may help in decision making for release of units for paediatric/low weight versus adults/ higher weight patients. adopting a policy of optimizing dosage of rbc transfusion could have the potential to significantly improve rbc utilization and decrease patient exposure to allogenic blood. this would help further in the clinical transfusion practices based on evidence. a-s - nv more, p desai, s rajadhyaksha, a navkudkar and n deshpande transfusion medicine, tata memorial centre, homi bhabha national institute, mumbai, india background: red blood cell (rbc) transfusion is an important medical therapy benefiting the patient in a wide spectrum of clinical setting. critically ill intensive care unit patients in particular, as well as medical and hemato-oncology patients, are among the largest group of the user of rbc. periodic review of blood components usage is essential to assess the blood utilization pattern in any hospital or health care set up. our institute is a bedded tertiary care oncology centre with approximately , to , rbc transfusions annually. these transfusions are required in various stages of patient treatment like chemotherapy, radiotherapy, surgical and palliative care and there are established guidelines by the institute to be followed by clinicians. aims: to study clinical practices of rbc transfusions based on indications and to evaluate appropriateness of rbc utilization practices at the institute. methods: this was a prospective observational study, started after approval from institutional ethics committee. total of rbc transfusion events in adult patients over a period of four months were included and analyzed as per institutional guidelines for their appropriateness. details of transfusion events in form of pre transfusion hemoglobin, indication of transfusion, type of request, number of unit requested and issued, time of issue, site of transfusion and adverse reactions, etc were obtained from department of transfusion medicine records. overall statistical analysis was descriptive using spss software. chi-square test in cross tables was applied to see the relationship between different variables and considered significant if p-value was < . . results: total rbc transfusion events for patients were analyzed. there were ( %) events in patients of medical oncology and ( %) in patients of surgical oncology. maximum transfusions were received by patients in age group of to years ( %). total % of transfusion events were appropriate as per institutional guidelines. all transfusions administered in operation theatre were found to be appropriate with p value < . . inappropriateness was more %( / ) and significant in daycare setup (p < . ). anemia was the most common indication of rbc transfusion observed in % of events ( / ). total % rbc transfusions were given as planned and % as urgent transfusions. most common adverse transfusion event observed was allergic reaction in . % of total transfusion reactions. summary/conclusions: clinical practice of rbc transfusions in our hospital was largely found to be appropriate and rational with adherence to institutional guidelines. blood utilization audits should be conducted regularly by transfusion services and results should be discussed with clinician for ensuring judicious use of the scarce resource. the concept of transfusion safety officer (tso) can be introduced for better coordination between clinicians and blood transfusion services to improve practices. a-s - paul-ehrlich-institut, langen, germany on a global scale, blood services are quite diverse in regard to aspects like organisational structure, regulatory background, donor populations, donation rates or pathogen epidemiology. the world health organization (who) recognizes blood and blood products as essential medicines and provides guidance to member states for various aspects like blood regulation, best practices in blood collection and transfusion, or screening parameters. more recently a who guideline on residual risk of transfusion associated infections has been established which may facilitate decision-making for the most appropriate screening algorithms. it emphasizes the need for regional evaluation of screening assays and regulatory control of blood-associated ivds. background: babesia, a protozoan parasite that infects red blood cells, is a leading infectious cause of mortality in u.s. transfusion recipients. babesia is usually transmitted through the bite of an infected tick but may be transfusion transmitted (tt) or transmitted from mother to child during pregnancy. babesiosis is a world-wide disease; the ticks that carry babesia have a global distribution. babesiosis has been reported throughout europe and in canada, korea, india, and japan. prospective testing of blood donations in endemic areas of the u.s. revealed . % of donors were positive for babesia dna or antibodies (moritz, nejm, ) aims: -to report results of ongoing babesia clinical trial -to explain significance of babesia as a tt infection methods: in cobas â babesia for use on the cobas â / systems, is a qualitative polymerase chain reaction nucleic acid amplification test, developed to detect in whole blood (wb) donor samples the babesia species that cause human disease: b. microti, b. duncani, b. divergens, and b. venatorum. testing began in october under a u.s. fda-approved investigational new drug application. wb was collected into a proprietary medium that lysed red blood cells and stabilized babesia rna and dna. donations were collected in states with high, low, and no babesia endemicity and screened as individual blood donor (idt) samples. reactive index donations were retested in simulated minipools of (mp ), plus idt replicates with cobas â babesia. reactive index donations were also tested with validated alternate babesia nat and for b. microti igm and igg antibodies. donors with reactive results were invited to enroll in a follow-up study to test for additional evidence of infection. results: to date, , valid donations have been screened with cobas â babesia, and ( . %) were reactive. of ( %) initially-reactive donations were confirmed to be positive for babesia with a positive alternate nat or serology result. of ( %) confirmed-positive donations was collected in a state with low babesia endemicity (pennsylvania), and ( %) was collected in a state where babesia is not considered endemic (iowa). of ( %) confirmed positive donations were collected in states with high endemicity. of ( %) confirmed babesia-positive donations were detected in late fall or winter. all ( %) confirmed babesia-positive donations were reactive in mp . serology results are available for of confirmed-positive donations: at index, of confirmed babesia-positive donations were only igg-positive, while none were only igm-positive; were positive for both igg and igm. of the confirmed-babesia positive donations were negative for both igg and igm antibodies. cobas â babesia showed an overall specificity of . % ( , / , ; % exact ci: . %> %). summary/conclusions: the cobas â babesia test successfully identified babesiapositive donations, including confirmed-positive donations with no igm or igg reactivity. donations were collected in states considered low-or non-endemic for babesia. confirmed-positive donations were collected outside of the summer babesia season, when most clinical cases occur. screening with cobas â babesia continues in several laboratories. cobas â babesia is not fda licensed or available commercially. background: babesiosis in humans is caused by the erythrocytic protozoan parasite, babesia microti which is transmitted by tick bites, but is also transfusion transmitted. although frequently asymptomatic or presenting with flu-like symptoms in a normal host, if immunocompromised infection can lead to severe complications and death. b. microti is endemic in the north eastern/upper midwest united states where partial testing of donations has been implemented. in canada, a study of~ , donors did not identify any b. microti antibody-positive samples, suggesting low risk at that time, but risk should be monitored. aims: to evaluate the prevalence of b. microti-positive donations in potentially atrisk areas in canada. methods: between july and november , , blood donor samples were selected from sites near the us border. minipools were tested for b. microti nucleic acid by transcription mediated amplification (tma) using the procleix â babesia assay on the panther â system with individual testing on reactive pools. reactive donations were also tested by b. microti-specific: american red cross (arc) igg immunofluorescence assay [ifa] and imugen ifa/pcr. a subset of , tma-negative samples, primarily from the province of manitoba and eastwards to nova scotia, were tested for b. microti antibody using the arc ifa and if positive, the imugen ifa/pcr. donor age, sex, donation status, residential location and collection site location were recorded. donors who tested reactive/positive were informed, deferred and asked about risk factors (possible tick exposure and travel within canada, the usa and elsewhere, history of symptoms) and a follow-up sample was requested for supplemental testing (tma, arc ifa). reactive donations were removed from inventory. results: the , donor samples were proportional to collections in target geographic regions. age group, sex and donation status were also similar to the donor base in the collection areas. one sample from winnipeg, manitoba was tma reactive and antibody positive on supplementary testing. the donor did not remember symptoms or spending time in wooded areas. he visited the city of fargo, north dakota, usa. the subset of , samples tested for antibody were also proportional to collections in the targeted areas. four antibody-positive samples were identified from mid-september to october , all in south western ontario near lake erie. none were tma reactive. three were interviewed and none remembered any symptoms, any likely tick exposure, or relevant travel within canada or the usa. summary/conclusions: this is the largest b. microti prevalence study in canada. the results indicate very low prevalence with only tma-confirmed-positive donation of , tested. the donor was from the only region in canada where one autochthonous human case has been reported and active tick surveillance identified b. microti positive tick populations. seropositive donations in south western ontario may suggest low prevalence in that region, but interpretation is less certain due to lack of corroborating supplementary results or case history. given the close proximity to the us border, forgotten us travel should not be ruled out. a-s - background: the protozoan parasite toxoplasma gondii is prevalent in animals and humans worldwide. wild and domestic felids are the definitive hosts, and homoeothermic animals serve as the intermediate ones. after primary infection, the parasite persists lifelong within latent tissue cysts. transmission is by ingestion of undercooked or raw meat infected with cysts, by ingestion of food or water contaminated with oocysts, or transplacentally. however, it can also be acquired by blood transfusion and organ transplantation. toxoplasmosis can be a severe disease in immunosuppressed people and neonates whose mothers have acquired primary infection during pregnancy. aims: there is no information about the specific epidemiology of t. gondii infection in blood donors in portugal. therefore, we sought to determine the seroprevalence of t. gondii and associated risk factors in the population of blood donors in portugal. methods: between september and july , blood donors who attended the portuguese blood and transplantation institute blood banks located in oporto, coimbra and lisbon, and also at regional blood collection meetings, were invited to participate in the study. a written informed consent was obtained and a questionnaire about socio-demographic and behavioural variables was answered. sera were assessed for igg antibodies to t. gondii by a modified agglutination test (mat) commercial kit (toxo-screen da â biom erieux, lyon, france). results: of the blood donors (mean age . ae . ; range - years old), . % were positive for antibodies to t. gondii. when questioned about toxoplasmosis, almost half the blood donors did not have any knowledge about the disease. the centre of portugal had the highest seroprevalence ( . %) followed by the north ( . %) and the south ( . %). blood donors living in rural areas had a significantly higher seroprevalence (p = . ) than those living in urban areas. seroprevalence increased with age, with the highest seroprevalence ( . %) found in the age group of - years old (multiple logistic regression [mlr]: or = . ; ci: . - . ; p < . ), and decreased with educational level (p < . ). engaging in soil-related activities (gardening or agriculture) was significantly related to t. gondii seropositivity (p = . ). regarding water consumption, untreated sources (even though including mineral and tap water) was confirmed as a risk factor (mlr: or = . ; ci: . - . ; p = . ). other behavioural and eating characteristics, including cats in the household, eating raw or undercooked meat, processed pork products, or not washing raw fruit and vegetables before eating, were not associated with t. gondii infection. summary/conclusions: the risk of t. gondii transmission through blood transfusion is low, and serologic testing of antibodies, with exclusion of blood donors, appears not to be feasible. immunosuppressed individuals, organ transplant patients and pregnant women, should receive t. gondii antibody-negative blood components for transfusion. this study explored the epidemiology of t. gondii in portugal thus providing useful information on the seroprevalence and potential risk factors for t. gondii transmission. information regarding toxoplasmosis and its prevention could be promoted by medical and public health authorities among blood donors, and also the general population, when addressing policies, and designing screening programs, for monitoring and controlling infection and disease in portugal. a-s - who is syphilis testing excluding? c reynolds , c pearson , k davison and s brailsford nhsbt/phe epidemiology unit, nhs blood and transplant nhsbt/phe epidemiology unit, public health england, london, united kingdom background: screening for treponemal antibodies to detect syphilis in blood donors has been in place in england since the s. there have been no reported syphilis transfusion transmissions in england since records began in part due to sensitivity of the organism to cold storage. since we have specific tests in place for other sexually transmitted infections such as hiv and hepatitis b virus (hbv), the utility of syphilis screening is often questioned. however, it may be a useful proxy for higher risk behaviours particularly following shortening of deferrals for higher risk sexual behaviours from to months in november and against a background of increasing infectious syphilis in the general population. aims: here we describe the epidemiology of recently-acquired syphilis in blood donors in england compared with hiv and acute hbv infection between and . methods: monthly donation testing results are collected from the nhs blood and transplant (nhsbt) screening centres and reference laboratory. the demographics, possible sources of infection, and compliance to donor selection in confirmed positive donors are collected by proforma at post-test discussion with the nhsbt clinical team. recent syphilis is classified as igm positive and/or recent history including a negative donation within months for regular donors. results: between and there were recent syphilis cases, hiv and acute hbv infections identified by donation screening. recent syphilis rates per , donations increased from . to . whereas hiv decreased from . to . with less than positive donations in . acute hbv rates rose slightly from . to . in . males outweighed females accounting for . %, . % and . % of cases of recent syphilis, hiv and acute hbv respectively. nearly a quarter of cases of recent syphilis and hiv were seen in donors below years old. of the male donors with recent syphilis, . % reported sex between men and women (sbmw), . % sex between men (sbm) and . % did not report a risk. this contrasted with hiv where . % of male donors reported sbm, just . % not reporting a risk. overall , and males with recent syphilis, hiv or acute hbv respectively were non-compliant to the sbm deferral in place at the time of donation. in , donors with recent syphilis aged - years (median years) were excluded from the donor pool, including non-compliant to the sbm deferral. there were fewer than hiv cases identified in , all over years old, all compliant, reporting sbmw. of the hbv acute cases in , were male, all but one in the and over age-group. summary/conclusions: over the year period demographics of recent syphilis cases appeared similar to hiv with highest rates in young males, albeit lower proportions reporting sbm. following the switch to a month deferral, hiv case detection continued at low level, while syphilis screening continued to exclude higher numbers spanning all age-groups, potentially at risk of other sexually transmitted infections, including non-compliant donors. background: globally, an estimated million blood donations are given annually. in the blood service we are obliged to monitor donor health and ensure that blood donation is safe. in recent years, large-scale blood donor cohort studies in several countries have increased our knowledge on health effects of blood donation. health concerns relate both to immediate side effects like fainting and to possible long-term health issues related to repeated blood or plasma donation. the studies have provided us with data that can now help us introduce an evidence-based individualised donor care -a parallel to personalised medicine. individualised donor care in the management of iron depletion: studies have shown that a large percentage of our frequent whole blood donors, especially young women, are iron depleted. iron depletion is a strong predictor of deferral for low haemoglobin but has also been associated with e.g. restless legs syndrome and lower birth weight in children of frequent donors. the risk of iron deficiency can be mitigated by ferritin-guided prolongation of interdonation intervals or by iron supplementation. prolongation of interdonation intervals can challenge our inventories. iron supplementation, on the other hand, may give gastrointestinal side effects and other effects have been proposed as well, e.g. the masking of malignant disease and increased iron availability with subsequent risk of infection. in a large study we found that iron supplementation is not associated with increased risk of infection. what is the optimal balance between iron supplementation and prolongation of interdonation intervals? a growing number of blood services have implemented various flavours of iron management regimens generating more results. moreover, genetic studies in e.g. the uk, us, holland, and denmark can help us to find donors at high risk of iron depletion or low haemoglobin. we can use all these data in a big data approach in the pursuit of an individualised risk assessment model. other risks for blood donors: the presentation will also cover other risks associated with donation. new studies identify predictors of fainting after blood donation and also new interventions to prevent fainting. the global demand for plasma derived medicinal products has increased severalfold the last years. plasma donors are bled up to times per year in the us. very little is known about the health effects of frequent plasma donation. we know that immunoglobulin levels decrease with frequent donation but how does this affect health? summary/conclusions: the precautionary principle mitigates risk through early intervention prior to evidence. we tolerate next to no risk of transfusion-transmitted infectious diseases. the health of the blood donors, however, has not been protected similarly. we owe to our whole blood and plasma donors to investigate health effects of blood donation and ensure their safety. while the first attempts may not be perfect, we now have the tools to construct models for individualised donor care. background: in , the isbt, aabb, ihn and eba jointly issued the standard for surveillance of complications related to blood donation which categorized donor adverse events (dae) into categories ( subcategories) defined by specific criteria. severity and imputability were briefly described but were optional. subsequent validation of these categories demonstrated consistency in categorizing reactions, but wide variation in assignment of severity. in , with international input, the aabb donor biovigilance committee developed a severity grading tool (sgt) using a recognized medical adverse event grading system in which neutral grades replace subjective terms (mild, moderate, severe). aims: a large us blood collection establishment (bce) applied the draft sgt to assess its use in real cases of dae. methods: we performed retrospective analysis of all allogeneic and apheresis needle-in donations between / / to / / . severity grading was assigned based on criteria defined by the sgt. database review of dae was performed, and each event was assigned a grade based on the type of outside medical care (omc), and on specific key search terms. search terms for omc included emergency room, emergency medical response, urgent care, healthcare professional, and hospital admission. additional specific key search terms included fracture, concussion, laceration, dental injury, surgery, and hospitalization. since duration and activities of daily living (adl) limitations were not captured in our dae database, cases in our dae claims' database were reviewed. case files of events classified as grade or higher were individually evaluated by a physician for grading accuracy. results: in , , needle-in collections, , dae were graded for severity. the majority ( , , . %) were vasovagal reactions (vvr), followed by , apheresis-related ( . %), , needle-related ( . %) and allergic ( . %) events. the majority of dae were grade accounting for . % of all dae, followed by grade ( . %), and grade ( . %). there were grade and no grade dae. among the vvr, . %, . %, . % and . % were grade , , , and respectively. grade vvrs included concussions, fractures, dental injury, and pre-faint and fainting events requiring hospitalization for work-up. two grade vvrs involved falls resulting in intracranial hemorrhage requiring immediate medical intervention. for allergic and apheresis dae, there were only and grade reactions respectively, and no grade or events. needle-related dae included . % grade , . % grade , . % grade , and no grade events. of the six grade needle-related dae, were nerve irritations lasting > months, and were dvts requiring hospitalization. summary/conclusions: the sgt provided consistent assignment of severity for the majority of dae, based on outside medical care and specific key search terms. assignment of severity based on impact on activities of daily living or on duration of injury/condition requires tracking over time making such assignments more difficult; modification of our dae tracking database and claims database to capture adl and duration should improve severity assignment for such cases. background: the international haemovigilance network (ihn) has collected aggregate data on complications of whole blood and apheresis donations from member national haemovigilance systems (hvs) since . aims: we analysed the data collected in - in order to learn from the data and consider future improvement of data collection. methods: national hvs entered annual data on donor complications in the passwordprotected "istare" (international surveillance of transfusion adverse reactions and events) online database. from the donor complication spreadsheet allowed entry of separate data for whole blood donation (wbd) and apheresis, but also provided an option for entering data for all donation types. annual numbers of whole blood and apheresis donations were also collected. the harmonised international standard definitions were implemented in . reactions were captured according to severity level (mild, moderate, severe) but without distinction between donor sex or first time vs repeat donation. extracted data were used to calculate national and aggregate donor complication rates (generally per donations). results: twenty-four hvs provided figures for donations and donor complications for one or more years (median years per country was , iqr - ). the total number of country years (cy) was , covering million donations. the overall complication rate was . / donations and the median country rate was . complications/ donations (iqr . - . ). rates were generally consistent within a hvs from year to year but showed considerable variation between hvs; this was also the case for reactions classed as severe. not all countries differentiated between mild and moderate reactions and some reported all reactions under a single severity level. vasovagal reactions were the most commonly reported complication: overall . / donations, median country rate . / donations (iqr . - . ). rare and apheresis-related types of complications such as generalized allergic reaction ( . per , , cy), and major blood vessel injury (category available since ; overall . per , , cy) were only reported occasionally. eighteen of the hvs provided separate data for complications of whole blood and apheresis donations in one or more years (total cy, . million wbd and . million aphereses, total million donations). for these hvs the median rate of vasovagal reactions was . / wbd (iqr . - . ) and . / apheresis procedures ( . - . ) . reported haematoma rates were higher for apheresis than for wbd: the median per hvs was . / wbd (iqr . - . ) vs . / aphereses ( . - . ); rates of arm pain and/or nerve injury (not separated in - ) also tended to be higher: median . / with wbd, iqr . - . , vs . / with apheresis, . - . . summary/conclusions: international reporting allows hvs to study rates of blood donation complications, to distinguish between wbd and apheresis complication rates and capture information about very rare events. variability of reporting and of severity assessment between countries impairs the feasibility of comparisons between hvs. work is needed to improve harmonisation of classification of donation complications and severity assessment for data comparison and research. background: to prevent iron related hb loss, screening with ferritin testing was implemented in stockholm county (approx. registered blood donors) during a two-year roll-out. iron supplementation is offered to blood donors but has not prevented hb deferrals resulting in control visits per year. ferritin testing is hypothesized to increase iron compliance. aims: implementation of ferritin testing for surveillance of iron levels for the entire blood donor population with specific attention to new donors, women returning after pregnancy, donors with low hb and at return visit after low hb. yearly testing of plasma and platelet donors. methods: ferritin testing, following a staff education program, was implemented for applicant donors, donors with low hb, women after pregnancy, apheresis donors, followed by screening of registered blood donors per donation site. after initial screening, donors will be tested at each th (women) or th (men) donation, and with yearly testing of young adult blood donors below years. six nurses were educated to process ferritin and blood count results. donors with aberrant ferritin were contacted by letter. results: establishment of cut-off levels and algorithms for ferritin testing and iron treatment was evidence based but met practical limitations such as number of analyses and results that could be processed per week, limitations in liss set-up, blood demand contra preferred cut-offs, iron supplementation compliance. for applicant donors, hb testing show that % of female and % of male applicants cannot be registered because of low hb ( and mg/l respectively). adding ferritin testing, a preferred cut-off level of lg/ml (male reference level), would result in additionally % female and . % male applicant donor loss. as this would threat the blood demand, cut-off was set to lg/ml for women, above the female reference lg/ml, with an acceptable % loss of female applicant donors. for registered blood donors, mg of extra iron tablets were offered at low ferritin ( - lg/ml). this was sometimes combined with prolonged intervals and often repeated before ferritin was restored above lg/ml. donors with ferritin below lg/ml (in . % applicant donors, . % registered donors) or above lg/ml ( . % applicant donors, . % registered donors) were deferred and recommended to see their physician. for hb deferral, the interval was prolonged from to months, irrespective of ferritin levels. this, together with iron supplementation, resulted in an increase from % to % approved hb at return. the team of nurses processing ferritin and blood count results ( ½ nurse fulltime weekdays) reacted to approximately donor results daily, representing % of test results. summary/conclusions: many female donor applicants have suboptimal ferritin levels although they meet required hb for donation. iron treatment was added to retain donors with low ferritin as only prolonged intervals may danger the blood supply. for implementation of ferritin testing, it is necessary to have a well-functioning and agile organization to create and apply algorithms for testing, extension of intervals and iron treatment. background: since november a new donor screening regime is introduced in the netherlands where serum ferritin levels in whole blood donors are measured periodically to further control potential iron deficiency in donors. donor deferral thresholds are set at and ng/ml, and donors are deferred for six and twelve months respectively if ferritin levels are below these values. as limited information is available on ferritin recovery in whole-blood donors, the policy is introduced in parts such that adaptations to the implementation may be considered based on intermediate results and the impact of the measure on donor well-being can be evaluated. aims: to assess the effect of donor deferral on donor ferritin levels. methods: ferritin levels are measured in new donors and at every fifth donation in repeat donors. donors with ferritin levels below the indicated thresholds are deferred and ferritin is re-evaluated at their return for donation after six or twelve months. the policy allows estimating long term trends in ferritin levels post donation in repeat donors. as ferritin levels are measured in all new donors a reference distribution of ferritin levels in healthy individuals is obtained as well. results: among repeat donors % ( % of , male donors, and % of , female donors) have ferritin levels below ng/ml and are deferred for their next donation. furthermore, the distributions of ferritin levels in repeat male and female donors are similar and each has an average ferritin level of ng/ml. in contrast, we found that only % of new female donors (n = , ) and . % of new male donors (n = , ) have a ferritin levels below ng/ml. the average ferritin level in new donors was ng/ml for males and ng/ml for females. comparing the ferritin levels in new and repeat donors, a reduction in average ferritin levels between . and . was observed in female donors and between . and . in male donors. both ratios increased with donor age. at the end of december donors with low ferritin levels returned for donation after six or twelve months deferral. repeat ferritin measurements show that on average the ferritin levels in female donors increased by ng/ml per year whereas average ferritin levels in male donors increased by ng/ml per year. summary/conclusions: in line with earlier findings in literature our results show that repeat donations substantially reduce ferritin levels in repeat donors. these range from . to . in female and from . to . in male donors, who generally have higher ferritin levels. deferral of donors with low ferritin levels seems to be effective in increasing ferritin levels in donors, however, further monitoring of follow-up in repeat donors is warranted to see whether the proposed scheme allows for sufficient donor recovery over time. there are~ different rare diseases and the genes for half have been identified. approximately . million uk citizens experience premature ill-health because of a rare disease. a conclusive diagnosis is generally not reached and on average the diagnostic odyssey lasts . years. the main aims of the , genomes project are to reduce the diagnostic delay by embedding whole genome sequencing (wgs) to accredited standards in the care path of patients with undiagnosed rare diseases. the project started in and dna samples from , nhs patients and their close relatives have been analysed by wgs. here we review the results from the nihr bioresource pilot study for the , genomes project comprising phenotype and genotype data from , individuals recruited at hospitals using approved eligibility criteria for rare disease domains. we determined the population structure including ethnicity and relatedness estimation, high level phenotypes collected using human phenotype ontology (hpo) terms and quality control and summary metrics for samples and variants. the sequence resource contains over million unique variants in the , genetically independent samples, with % of variants previously unobserved in other large scale publicly available genome datasets. we summarise the curation of gene lists and pertinent findings in , unique diagnostic-grade genes for the domains. over , reports assigning pathogenic or likely pathogenic causal variants have been issued with diagnostic yields varying between domains from . % to %, while the proportion of novel causal variants ranged between % and %. we show the power of the bayesian association test, bevimed, to recapitulate decades of clinical genetics discoveries and by identifying > novel genes and novel diseasecausing variants in the non-coding space of the genome. we show how typing data for all red cell, hpa and hla class antigens can be extracted from wgs data. we mined the data from the , genomes project and similar sequence resources to re-version the probe content of the uk biobank axiom array. we genotyped donors from england and the netherlands with this new array and observed a . % concordance when comparing , blood centredetermined antigen typing results with genotype-determined ones. for the red cell and hpa antigens that were available for , donors, the array typing provided a . -fold increase in typing results per donor ( . vs . ) and rare donors were identified. using the genotyping data we identified . times more compatible units among this cohort of donors when blood demand was modelled using referral data from , english patients with more than three red cell alloantibodies. in conclusion the , genomes project has shown the feasibility of using wgs across a universal healthcare system to deliver a diagnosis for patients with rare diseases. based on these results the nhs has commissioned the analysis of another , dna samples from patients with cancer and rare disease. with analysis of dna by wgs and arrays becoming part of routine clinical care, blood services must develop competencies to extract transfusion and transplant relevant information from clinical-grade genotyping data. next-generation sequencing (ngs) enables the sequencing of thousands of genes, the exomes, and even entire genomes by single experiments at a reasonable price. there have also been advances in cytometry: use of antibodies with different fluorescence tags enables simultaneous monitoring of the expression of dozens of antigens. however, immunological methods cannot detect every variant discovered by ngs. genome sequencing reveals not only the exome but also the regulatory elements of transcription/translation, such as promoters and enhancers. rna sequencing determines which genes and spliced transcripts are expressed. it is amazing to realize how much this novel technology has been contributing to the better understanding of various biological phenomena. since the initial cloning of the human blood group a transferase cdnas in the early s, we have been studying the abo genes, a and b glycosyltransferases, and a and b oligosaccharide antigens. various scientific disciplines including genetics, immunohematology, biochemistry, enzymology, and glycobiology have been applied to their study. we have made several important scientific contributions. we demonstrated the central dogma of abo: the a and b alleles at the abo genetic locus encode a and b transferases, which synthesize a and b antigens, respectively. we elucidated the allelic basis of the abo system. we found amino acid substitutions between a and b transferases and inactivating mutations in o alleles. we became the first who succeeded in the abo genotyping, discriminating the aa and ao genotypes, as well as the bb and bo, which was impossible by the immunological approach. we have taken a simple experimental strategy: preparation of eukaryotic expression constructs of a/b transferases and their derivatives, dna transfection to human hela cells or their sublines, and immunological detection of the a/b antigen and/or biochemical examination of the enzymatic activity. we used this to show that the codons and are crucial in determining the sugar specificities of galnac/galactose of a/b transferases. we also identified mutations in several subgroup alleles causing restricted substrate use and diminished transferase activity. we also showed that cis-ab and b(a) alleles specifying the expression of both a and b antigens by single alleles encode a-b transferase chimeras. since then, other scientists have characterized more than abo alleles. recent human genome sequencings have identified many more single nucleotide polymorphism variations. the genome sequences of many species are also available. taking advantage of those sequences and associated information, we have expanded our research to include evolutionarily related a , -gal(nac) transferases and their genes and scaled it up from the genetic to genomic level. in this talk, i would like to present the followings. : our elucidation of the molecular genetic basis of the abo blood group system (as requested by the organizer); : identification of novel abo alleles by others; : more snp data from genome sequences and potential problems for abo genotyping; : findings obtained from analysis of abo genes from other species; bacteria, vertebrates, to primates; : a , -gal(nac) transferases and their genes and the crosstalk between a transferase and forssman glycolipid synthase (fs); and : the potential causes of generation of abo polymorphism and of species variations of the gbgt gene specifying the fors polymorphism. in recent years, there has been a concerted effort to improve our understanding of the quality and effectiveness of transfused blood components. the expanding use of large datasets built from electronic health records allows the investigation of potential benefits or adverse outcomes associated with transfusion therapy. together with data collected on blood donors and components, these datasets permit an evaluation of the effect of donor and blood component factors on transfusion recipient outcomes. large linked donor-component recipient datasets provide the power to study exposures relevant to transfusion efficacy and safety, many of which may not otherwise be amenable to study for practicality or sample size reasons. analysis of these large blood banking-transfusion medicine datasets allow for characterization of the populations under study and provide an evidence base for future clinical studies. knowledge generated from linked analyses has the potential to change the way donors are selected and how components are processed, stored and allocated. however, unrecognized confounding and biased statistical methods continue to be limitations in the study of transfusion exposures and patient outcomes. results of observational studies of blood donor demographics, storage age, and transfusion practice have been conflicting. this review will summarize statistical and methodological challenges in the analysis of linked blood donor, component, and transfusion recipient outcomes. c-s - a large deletion spanning xg xg and gyg gyg constitutes a genetic basis of the xg null phenotype, underlying anti-xg a production background: the xg blood group system comprises the homologous antigens xg a and cd . the cd gene resides within pseudoautosomal region on the short arms of the sex chromosomes and thus mimics autosomal inheritance. xg, on the other hand, is x-linked and straddles the pseudoautosomal boundary; a truncated pseudogene composed of only the first exons remains on the y chromosome and therefore males carry a sole full-length copy of xg. this phenomenon manifests as asymmetric frequencies of the xg(a+) phenotype between the sexes: roughly % of women and % of men are xg(aÀ). also, whilst xg a immunization is rare, the vast majority of all anti-xg a makers reported are men. recently, we reported that the rs c variant disrupts a gata motif between xg and cd . this abolishes erythroid xg a expression and causes the common xg(a-) red cell phenotype. however, rare individuals who produce anti-xg a cannot be accounted for by this finding. we hypothesized that a structural defect in the xg coding region causes the true xg null phenotype underlying anti-xg a production. aims: we undertook to determine a genetic explanation for anti-xg a production. methods: genomic dna (gdna) was extracted from two whole blood samples and cell-free dna (cfdna) from archived plasma samples from donors producing anti-xg a ; one cfdna sample was from a female donor and the rest from males. polymerase chain reaction (pcr) experiments, sanger sequencing, and database searches were performed to identify and confirm the deletion. aliquots of gdna from four males reported to carry a similar deletion in the genomes project were also tested. results: in one gdna sample, exon-specific pcr identified a deletion involving part of xg and the downstream gene gyg . database searches indicated that the most likely deletion was the infrequent genomic structural variant esv reported in the genomes project. further analyses with a short ( bp) and a long ( bp) pcr amplicon across the suspected breakpoint determined that this deletion was approximately kb and corresponded well with esv . this finding was confirmed in the second gdna sample. given the rarity of anti-xg a producers, we decided to test for the same deletion in cfdna extracted from old archived plasma samples. of the cfdna samples, poor quality in four samples prevented amplification even from control reactions and one was contaminated with bacterial dna. in the remaining nine samples, eight could be amplified for the deletion-specific -bp short amplicon while one was negative for the deletion. sanger sequencing of the amplicons revealed a heterogeneous repetitive dna element, ltr b, hinting at a previously-reported recombination event. this deletion was not detected in the samples from the genomes project which reiterates the previously identified deficiency in data interpretation and reporting for deletions. summary/conclusions: a large deletion disrupting the xg and gyg genes accounts for the xg null phenotype underlying the majority ( of ) of anti-xg a makers. one sample remained unexplained, indicating further heterogeneity to be explored. our data help to explain why anti-xg a production is rare and has primarily been reported in men. background: s and s antigens encoded by gypb differ by one nucleotide (nt), c. c>t, p.thr met. two different genetic backgrounds are associated with silencing of s antigen and a u+ w phenotype. these include the nt change c. c>t (p.thr met) causing partial exon skipping and designated gybp* n. (gypb*ny) and c. + g>t, an intron change causing complete skipping of exon , designated gypb* n. (gypb*p ). aims: samples from three individuals, a previously transfused african american sickle cell patient (p ), a blood donor of unknown ethnicity (p ), and an african american patient (p ) (lapadat r. aabb abstract) were investigated for discrepant serologic and molecular results when determining s and s phenotype. methods: standard methods were used for rbc typing with licensed s and s reagents and rbcs from donor p were also tested with monoclonal and polyclonal anti-s and anti-s. dna was isolated from wbcs and hea precisetype performed on p and p . p was also tested by gypb*s/s as-pcr, exon pcr-rflp for c. + g>t and as-pcr for c. c>t. p was tested for gypb*s/s and c. c>t and c. + g>t changes by a real-time pcr-fluorogenic ' nuclease taqman chemistry. for all, gypb exons - were amplified and sanger sequenced and aligned to consensus using clustal x. results: rbcs of all three probands typed s-and strongly s+ while dna testing indicated c. t/c (gypb*s/s). assay for the two common gypb*s silenced alleles, c. c>t and c. + g>t, indicated all three samples had both silencing mutations previously reported to be independently associated with a sÀu+ w phenotype. hea precisetype could not interpret this novel allele combination and indicated gypb*s as pv (possible variant). samples were confirmed to be heterozygous for c. c/t, c. c/t and c. + g/t by exon specific sequencing and as-pcr, pcr-rflp and real-time pcr. by long range sequencing of gypb, all three were heterozygous c. t/g and c. a/g (p. leu/trp), c. a/t (p. thr/ser), c. a/g and c. g/t (p. glu/gly), c. c/t (s/s), c. g/t (p. val/leu), c. c/t (p. thr/met), and c. + g/t. all samples were also c. g/g (p. ser) and heterozygous for several previously recognized silent changes in exon , c. t/c, c. t/c and c. a/g. summary/conclusions: we report a novel silenced gypb*s allele that can confound gypb genotyping interpretation. the allele was found in three probands associated with a sÀs+ phenotype. in these samples, two changes previously reported to be inherited independently and both associated with silencing of s antigen are carried on the same allele. dna-based testing could not rule out that c. t or c. + t are separate and that gypb*s was also silenced. robust s+ rbc typing indicates both changes are on gypb*s. gene sequencing confirms the c. + t change is on a gypb* n. [gyp*he(ny)] background. c. c>t (rs ) and c. + g>t (rs ) have a frequency of . respectively . in the african population (exac). although we identified samples, the frequency of this novel allele is unknown. background: the lutheran blood group system currently consists of antigens. these antigens are of low immunogenicity and may cause mild-to-moderate transfusion reactions and hemolytic disease of the fetus and newborn. the activation of lu-glycoprotein/bcam on red blood cells (rbcs) and its interaction with laminin- a is thought to play a role in vaso-occlusion in sickle cell disease and other hematological disorders. the two glycoprotein isoforms lu-glycoprotein and bcam are encoded by the bcam gene which consists of exons located on chromosome q . . a number of rare lutheran phenotypes have been previously recorded in israel, including lu:- , observed among iranian jews, lu:- in one thalassemia patient and one case of lu:- . in this report, a previously transfused pregnant arab patient with b-thalassemia intermedia was investigated because she presented with an antibody to an unknown high frequency antigen (hfa), potentially related to the lutheran system. aims: to characterize a novel lutheran antigen through serological and molecular investigation of a patient with a lutheran related antibody. methods: initially, the red cell phenotype and the presence of a lutheran related antibody in the serum of the patient were detected by standard serological techniques, utilizing enzyme treated and chemically modified cells and rare cells and sera from the nbgrl collection. further serological investigations were carried out using standard iat (liss tube and bio-rad gel) technique. plasma inhibition studies were performed using soluble recombinant lu protein (srlu). eluates were prepared using acid elution method (gamma elu-kit ii). genomic dna was isolated from whole blood and all exons of the bcam gene were amplified by pcr and directly sequenced by sanger sequencing. the impact of the identified mutation on lutheran glycoprotein structure was studied by molecular dynamics calculations. results: the patient's plasma reacted with all cells tested, except for three examples of in(lu) cells and cells treated with -aminoethylisothiouronium bromide, trypsin and a-chymotrypsin. inhibition studies with srlu protein showed complete inhibition of the antibody, thereby confirming the antibody to be directed toward an epitope on the lu-glycoprotein. in addition, testing of inhibited plasma revealed the presence of underlying anti-e and anti-fy a . an eluate was prepared to isolate the patient's lu-related antibody and this eluate was found to be incompatible with examples of lu:- , lu:- , lu:- , lu:- , lu:- , lu:- , and lu:- cells, whereas in(lu) were compatible. results of serological typing of the patient's cells, for lu system hfas, could not be conclusively determined due to the patient having been recently transfused. however, results suggested (through absence of mixed field reactivity) the patient's cells to be lu: - , , , , ,- , . bcam sequence analysis confirmed the patient to be lu* , lu* and revealed a novel homozygous mutation c. a>c in exon , encoding p.lys gln in the lutheran glycoprotein. summary/conclusions: a novel homozygous mutation c. a>c (p.lys gln) in exon of bcam was identified in a patient with an antibody to a lutheran hfa. serological and genetic evidence presented here indicates discovery of a novel antigen of the lutheran blood group system, which we propose to name lura. background: lutheran glycoprotein and basal cell adhesion molecule antigen b-cam are two isoforms of a type i membrane glycoprotein residing on red cell surfaces. both isoforms are adhesion molecules with the main function of laminin binding, and both carry antigens of the lutheran blood group system (lu). the system currently comprises antigens, all encoded by mutations in the alternatively spliced single gene bcam located on chromosome . currently, isbt lists high incidence antigens in the system. aims: we report a case study of an individual with an unidentified alloantibody to high incidence antigen present in her plasma. samples from the patient and her family were investigated. we provide here serological and molecular evidence for a novel high incidence antigen of the lutheran blood group system. methods: serological investigations were performed by standard iat (liss tube and bio-rad gel) technique. plasma inhibition studies were completed with soluble recombinant lu (srlu) protein. genomic dna was isolated from whole blood of the patient and her family members; all the exons of the bcam gene were amplified by pcr and analysed by direct sanger sequencing. the impact of the identified mutation on lutheran glycoprotein structure was studied by molecular dynamics calculations. results: presence of a lu-related antibody in the patient's plasma was confirmed, reacting moderate strength by liss iat with untreated and papain treated cells. cells from the patient's mother, father and two siblings were all incompatible with her plasma, though weaker than panel cells, reflecting dosage. only in(lu) cells were compatible with patient's plasma. the antibody was successfully inhibited with srlu protein, thereby confirming the epitope recognised by the antibody resides on the lutheran glycoprotein. the patient's cells were found to be lu: - , , , , , , , , . bcam sequencing revealed a novel homozygous mutation c. g>a in exon , encoding p.val met in the lu glycoprotein. the c. g>a change appears to be an extremely rare mutation, listed in gnomad database with a frequency of . - and with no known homozygous examples. homology model of the novel lutheran glycoprotein was subjected to all-atom molecular dynamics calculations to analyse potential conformational changes. summary/conclusions: we report serological and genetic evidence for a novel antigen of the lutheran system, which we propose to name lunu. the evidence will be submitted to the isbt red cell immunogenetics and blood group terminology working party for consideration for allocation of antigen status. the absence of this high incidence antigen arises from a rare single amino acid change p.val met in the lutheran glycoprotein and the presence of anti-lunu in the patients' plasma was presumed to have been made in response to previous pregnancy. on native, papain-treated (diagast) and trypsin-treated (sigma) rbcs. genomic dna was extracted from peripheral blood cells by an automated method, amplified by sema a exon-specific primers and sequenced. results: the proband was a -year-old female patient of moroccan origin, group a, d+c+e-c+e+, k-, without transfusion history. she was hospitalized at weeks gestation for a blighted ovum requiring a manual vacuum aspiration, with a significant hemorrhage risk. a rbc antibody screening was performed by a first laboratory. the antibody reacted + by iat on all native reagent rbcs, with negative autocontrols, but was nonreactive on papain-and trypsin-treated cells. an anti-ge was initially suspected, due to the pattern of reactivity and ethnic background. new blood samples were referred to our national immunohematology reference laboratory. the antibody showed the same profile. anti-ge and anti-ch could be ruled out. the serum was nonreactive with two jmh:- and positive with two jmh:- samples. the patient was found to be jmh positive. in addition, a soluble recombinant jmh protein (jmh imusyn/inno-train) fully abolished the reactivity of the panagglutinating antibody. the antibody was an igg . overall, these results were consistent with a probable jmh variant and prompted us to perform sema a sequencing. three nucleotide changes were found, in homozygous state: a rare nonsynonymous change in exon , c. g>a (p.asp asn, rs , maf < . , sift score = ); a common synonymous change in exon , c. a>g (p.gln gln, rs , maf = . ); a rare non-synonymous change in exon , c. g>a (p.arg his, rs , maf < . , sift score = . ). the analysis of surface accessibility of asp and arg using the d structure of sema a (rcsb pdb- nvq https://www.rcsb.org/structure/ nvq) showed that only arg was predicted to be an exposed-epitope. interestingly, all other reported jmh variant phenotypes correspond to an arginine substitution. of note, we retrospectively found another individual of algerian ancestry (pregnant woman) with a pan-agglutinating igg antibody showing a similar pattern of reactivity, and with the same three changes in sema a. we unfortunately could not perform a cross-compatibility testing with the proband (no material left and unsuccessful contact). summary/conclusions: serological and molecular studies allowed us to provide evidence for a novel high-prevalence antigen in the jmh blood group system, very likely encoded by the p.arg his substitution in sema a. we propose to provisionally assign the name jmh for this antigen. interestingly, our two unrelated jmh:- individuals were from north african ancestry. background: the abo system was discovered almost years ago and the underlying structures later elucidated as carbohydrates carried by glycoproteins and glycolipids. the terminal trisaccharides galnaca (fuca )gal and gala (fuca )gal constitute the clinically important a and b epitopes, respectively. clausen et al. (pnas, ) showed that the a antigen could be extended to a repetitive glycolipid a epitope, galnaca (fuca )galb galnaca (fuca )galb glcnac-r. however, extended forms of b antigen have not been described. we encountered two related situations with unexplained serological reactivity. firstly, enzyme-conversion to group o treatment of group b (b-eco) red blood cells (rbcs) with a -specific gh family exogalactosidase (bzyme) abolishes b antigens as detected by hemagglutination and flow cytometry with all monoclonal anti-b tested. despite this, % of group o plasmas have been reported to give positive crossmatch results with b-eco rbcs. secondly, plasmas from ab and b individuals of the globoside-deficient p k phenotype contain anti-p and anti-px but react stronger with bpp-rbc than with app/opp-rbc. based on these findings, we hypothesized the presence of a bzyme-resistant, b-related glycolipid. aims: to identify the molecular basis of the enigmatic serological observations outlined above. methods: plasma and eluates from an a b individual with the p k phenotype were investigated by hemagglutination and flow cytometry, as were eluates from b p k and o plasma. rbc membrane glycolipids were extracted from two batches of pooled, expired group b-rbc units (frozen -litre reference preparation and confirmatory preparation from freshly collected units). native or enzyme-treated glycolipid fractions were analysed by liquid chromatography electrospray ionizationmass spectrometry (lc-esi/ms) and immunostaining of thin layer chromatography (tlc) plates. antigen expression in the h+bÀ human erythroleukemia (hel) cell line was analysed by flow cytometry following overexpression of selected glycosyltransferases. results: anti-p-depleted eluates made from a b p k plasma contained anti-px and antibodies of unknown specificity that reacted stronger with native or papaintreated bpp-rbcs compared to app/opp-rbcs. anti-px was removed by adsorption onto opp-rbcs but reactivity (here designated anti-extb) remained against b/bpp/b-eco rbcs. lc-esi/ms of glycolipid fractions from group b units revealed an unknown hexnac-hex-(fuc-)hex- hexnac-hex- hex heptasaccharide. upon b-nacetylhexosaminidase treatment of this candidate structure, a group b type hexasaccharide was produced, demonstrating that the terminal hexnac of the hexnac-gala (fuca )galb glcnacb galb glc heptasaccharide was b-linked. since the discovery of the anti-platelet effects of aspirin platelets have been a major therapeutic target for pharmaceutical companies and also a very profitable target. however, the effectiveness of aspirin has also been a challenge as it is an inexpensive drug and any new agent needs to show clear benefit over aspirin. furthermore the risk of bleeding from anti-platelet agents, especially cerebral bleeds, has also presented challenges. in the 's orally active gpiib/iiia antagonists were considered to be the 'super aspirin' but clinical trials showed increased mortality and ultimately this class of drugs was relegated to iv use only in high-risk patients. gpib/ix/v antagonists were also a promising drug target but no agent made it to market. the real breakthrough was the discovery of the p y antagonist clopidogrel which, in conjunction with aspirin, proved to be very effective at preventing thrombotic events and as a result it became the biggest selling drug in the world at the time. with clopidogrel now offpatent the combination of aspirin and clopidogrel is a formidable challenge to any new agent both in efficacy terms and pharmacoeonomic terms. so is there a future for new anti-platelet agents? with the growing awareness of the role of platelets in inflammation and an understanding of how the immune activation of platelets differs from the classical haemostatic activation of platelets it is now possible to develop novel anti-platelet agents that target inflammation without compromising haemostasis. it is here that we should look for the next generation of anti-platelet agent. c-s - university hospitals of geneva, geneva, switzerland platelet function defects, either congenital or acquired, are associated with increased bleeding risk, particularly in a perioperative setting. the use of platelet function assays is therefore tempting in order to tailor transfusion and limit platelet transfusion to those bleeding patients with impaired platelet function, as assessed by those assays. however, the current guidelines provide only weak recommendations supporting the routine use of these assays. indeed, there are numerous platelet function assays on the market that differ in their method of evaluation of platelet function and agreement between their results is at best moderate. the threshold values beyond which procedure-associated bleeding risk becomes worrisome is not standardized. moreover, observational studies addressing the predictive value of platelet function testing in perioperative or spontaneous bleeding are not consistent. finally, management trials with randomized patients assessing the benefit of platelet function testing are scarce. more recent data identified selected situations where platelet function testing may be useful though. i will review the different platelet function assays as well as selected clinical studies addressing the impact of platelet function testing to improve bleeding and transfusion-related outcomes. the latest recommendation will be addressed too. background: platelet refractoriness complicates the provision of platelet transfusions in management of thrombocytopenia in oncology patients. platelet refractoriness poses challenge due to alloimmunization to hla and human platelet antigens and is associated with adverse clinical outcomes. aims: a prospective study was undertaken to analyse result of platelet compatibility with post-transfusion platelet count increment and to ascertain presence of platelet antibodies as causative factor in platelet refractory oncology patients. pulmonary complication after blood transfusion is the leading cause of transfusionrelated morbidity and mortality, with an incidence reported between . - % of all transfused patients. the most important transfusion related pulmonary complications are transfusion associated circulatory overload (taco), transfusion related acute lung injury (trali) and transfusion associated dyspnea (tad). in this presentation the recent changes in the international definitions will be presented and discussed. furthermore, insights in the different underlying pathophysiologic mechanisms will be highlighted. in the past decades only for trali prevention strategies have successfully been designed and implemented. currently no evidencebased treatment strategy is available for any of these life-threatening syndromes. insight in the pathogenesis of pulmonary complications after transfusion should pave the way for future prevention and treatment studies. the issue of the impact of iron overload / toxicity on the hematopoietic stem transplantation (hct) outcome has been firstly addressed in the field of transfusion dependent thalassemia. today the concept has been extended to other diseases characterized by periods of variable duration of transfusion dependence such as myelodysplastic syndrome (mds) and myeloproliferative diseases. patients requiring regular blood transfusions certainly develop iron overload leading to tissues and organ damage. iron burden before transplant significantly impacts outcome and long-life posttransplant. it is well known that iron overload is deleterious for organs such as liver, heart and endocrine glands and it has been postulated could also increases the risk of infections and severe graft versus host disease early after hct. recent preclinical data has shown how increased production of reactive oxygen species (ros) resulting under iron overload condition, could impair the stem cells clonality capacity, proliferation and maturation. also, microenvironment cells could be affected through this mechanism. for this reason, iron overload is becoming an important issue also in the engraftment period early post-transplant. high baseline ferritin levels before hct have been shown to negatively influence clinical outcome, but nowadays, ferritin is considered a steady and not biologically active form of iron, while free iron forms as non -transferrin bound iron (ntbi) and labile plasma iron (lpi) are considered the main trigger of cell damage more representative of the dynamic tissue damage. the scientific community is moving the iron disease from a "bulky" disease, such as classically in thalassemia (based on quantitative iron parameters as ferritin, red blood cell transfusion number, mri) to a "toxic" disease (based on active and dynamic biological markers as ntbi/lpi). at this time in all the studies published on hct setting, only the correlation between direct or indirect estimates of iron overload (mainly serum ferritin) and outcome parameters has been explored, while the duration of exposure to toxic iron species has not been taken into account. the first study that explored the lpi role in relationship with outcome was published by wermke and colleagues in malignancies. they investigated the predictive value of both stored (mri-derived liver iron content) and non-transferrin-bound-iron, defined as enhanced labile plasma iron (elpi) on post-transplantation outcomes in patients with acute myeloid leukemia or mds. their prospective, observational all-ive study showed that patients who had raised elpi concentration at baseline, also had significantly increased incidence of non-relapse mortality at day ( %) compared with those who had normal elpi at baseline ( %) (p = . ). reinterpreting transplant predictive factors in the light of the current advances in understanding iron homeostasis further supports the concept that the key to successful transplantation is regular and life-long chelation therapy to consistently suppress tissue reactive iron species and prevent tissue damage in the years before hct. in transfusion medicine, the role of donor sex was long considered to be limited to the increased risk of trali observed after transfusions from female donors. this risk has been shown to be limited to female donors with a history of pregnancy and to plasma rich products (i.e. excluding red blood cell products, typically containing < ml plasma). until, in , we found that sex-mismatched red blood cell transfusions were associated with increased recipient mortality. since then, several other studies have confirmed these findings, but some studies also did not find an association. all of these studies relied on the analyses of routinely collected health care data, which was not primarily intended to be used for research. as a result, analyses are complex and often difficult to properly appraise based on published descriptions. therefore, the discussion about possible reasons for these discordant findings has largely focused on the methodological approaches of the different studies. other potential explanations include differences in donor or patient populations, production methods, or storage time of blood products. the different potential explanations are expected to be associated with different underlying biological mechanisms. therefore, further delineating which donor, patient, and product characteristics modify the observed association could provide more insight into the underlying mechanism. in , we observed that only transfusions from female donors with previous pregnancies were associated with increased mortality and only in male recipients under years. this leads us to postulate that pregnancy induced long term changes in the female immune system are transferred during red cell transfusion, with negative consequences for young male recipients. the low amount of plasma present in red cell products further lead us to assume a cellular component, like passenger leukocytes, to be involved. it has been shown that micro-chimerism of passenger leukocytes can persist for decades after transfusion, even of leuko-reduced blood products, suggesting long term immune-modulation could play a role. we hypothesized that passenger leukocytes would die during storage of blood products and the negative effect of ever-pregnant female donors, on the survival of young male red cell recipients, would therefore be attenuated by increased storage time. however, our data seem to indicate the opposite. the risk of death was increased over three-fold for young male recipients of old (> days storage) red cells from ever-pregnant donors, compared to for young male recipients of fresh (< days storage) red cells from ever-pregnant donors ( -year cumulative incidence of death . % versus . %). the negative control group (i.e. young male recipients of red cells from male donors) showed a much weaker association of mortality with storage time (i.e. . % versus . %). these findings seem to falsify our hypothesis that mortality could be caused by passenger leukocytes, establishing long term immune-modulatory effects. another potential mechanism that has been suggested could be the presence of cellfree dna in transfused blood products. this cell-free dna increases during storage. however, more research is needed both to establish if cell-free dna can also be linked to previously pregnant blood donors and by which mechanism it could negatively affect young male transfusion recipients. clinical trials (cts), the gems in clinical research for generating robust evidence in medicine and public health, are costly and complicated undertakings. in resource limited setting like sub-saharan africa (ssa) where the health systems are sub-optimal and where capacity for research is limited, the conducting of cts can be a daunting challenge. the challenges of undertaking cts in rls may be categorized based on the occurrence of the bottleneck(s) in relation to the ethics and regulatory approval process: pre-approval: protocol development: in order to develop a context-specific protocol which is subsequently subjected to an ethics and regulatory approval process, investigators need to review and ensure that the protocol is pragmatic and feasible with respect to implementation. this results into a time-consuming reiterative process of reality-checking the protocol. site selection: in light of the limited research infrastructure, investigators in rls and their developed world partners spend considerable time reviewing and selecting suitable sites for participation in the anticipated protocol for the cts. suitable sites are usually very few and with competing on-going studies. approval: institutional review board (irb) approval: the irb approval process can be quite lengthy ( - months) with considerable unpredictability in the periods between the initial and subsequent irb reviews. national regulatory approval: the requirements by national regulators are unusually innumerable with limited flexibility to accommodate specific cts. post-approval: the key post-approval challenges for cts implementation in rls are attaining appropriate participant enrolment and maintaining high retention rates. specifically, for participant enrollment, the challenge may be unforeseen competing cts targeting the same participant pool or community perspectives that may discourage participants from getting screened for the cts. retention may also be a challenge particularly where participants view enrollment as a chance to access healthcare services may therefore not have any incentive to keep in a study after the initial study visits. in conclusion, cts are complex undertakings wherever they are conducted but are doubly challenging in rls like sub-saharan africa. the bottlenecks at the preapproval, approval and post-approval stages are considerable. nevertheless, it is rewarding to perform ctus in rls given that the data generated therein is highly valued by national regulators and may hasten the registration process for medical products. background: interest in an appropriate and effective whole blood (wb) pathogen reduction technology (prt) is growing, especially in sub-saharan africa where the residual risk of transfusion-transmitted infections (ttis) remains unacceptably high and wb is still frequently used. cerus corporation, manufacturer of the intercept tm blood system, and swiss transfusion src are collaborating on a clinical development program to adapt intercept prt using amustaline (s- ) and glutathione (gsh) for red blood cells (rbcs) into an appropriate prt for wb in resource-limited settings in africa. treatment with amustaline/gsh has been shown to inactivate a broad spectrum of transfusion-transmissible pathogens in rbcs. studies with amustaline/gsh in wb have shown effectiveness against a duck hepatitis b virus (> . log reduction) and plasmodium falciparum (> . log reduction), with future studies planned. a wb prt system with amustaline/gsh also has the potential benefit of minimal electricity requirements. aims: to describe the safety and clinical objectives for a phase clinical trial using the amustaline/gsh prt system for wb in africa, and describe research and development efforts to adapt the intercept prt system for rbcs into a robust and appropriate wb system for settings with high burdens of tti and limited resources. methods: the protocol for a phase clinical trial using pathogen-reduced wb treated with amustaline/gsh in an african country is presented, as are current research and development activities related to the development of a prt system for wb. results: in the planned phase clinical trial in africa, clinically stable patients with anemia who require wb transfusion will be randomized into two study arms at a large medical center in a sub-saharan african country. enrolled patients will receive one unit of non-leucocyte-reduced wb treated with amustaline/gsh, or a unit of untreated control wb or rbcs. the primary safety endpoint will be the incidence of high-imputability transfusion reactions (swissmedic ≥grade ) within the first hours of transfusion. data will also be collected on all adverse events and transfusion reactions (all grades) and the development of treatment-emergent antibodies to pathogen-reduced wb or auto-antibodies within (ae ) days of the study transfusion. clinical efficacy will be characterized by hemoglobin increment hours after transfusion adjusted to hemoglobin dose and body weight. summary/conclusions: a prt system for wb is being developed based on the intercept prt for rbcs that is in advanced development in europe and the united states. intercept-treated rbcs have met efficacy and safety endpoints in phase clinical trials. the amustaline/gsh prt system used to treat intercept rbcs has demonstrated effective inactivation against a broad spectrum of agents that may result in ttis. a phase clinical trial using an adapted prt system for wb in africa is the first step in a clinical development program that includes additional pathogen inactivation efficacy studies and improvements to the wb prt implementation process. together, these developments and evaluations represent progress toward a realistic and appropriate prt for wb in africa and other resource-limited settings. background: in australia, demand for plasma-derived products has increased dramatically, and there is a need to increase plasma collections. first-time donor retention, including the rate at which first-time donors return, is a pressing issue. a quick return is optimal as this increases the overall plasma yield and is associated with long-term retention. however, we lack evidence of effective interventions to encourage first-time donors, particularly those donating plasma, to return and to establish a higher frequency donation routine. working from schultz's ( ) framework, this intervention study was based upon insights from interviews with first-time plasmapheresis donors. participants identified barriers such as time and lack of knowledge about plasmapheresis. facilitators included being able to help more people and to donate more frequently than allowed with whole blood. participants generally favoured donating at a frequency of every weeks. aims: the aim of this study was to test the effectiveness of three intervention conditions compared with the business-as-usual (bau) procedure on the proportion of donors returning to donate plasma and the number of plasma donations. we report on the data from months post-donation. methods: donors were randomly assigned to one of four study conditions. in conditions and , donors received an email one day after their initial donation. in the first condition, donors received the bau 'thankyou' email. donors in the second condition received an alternative email with content derived from the interview study. donors in the remaining conditions received either the bau email (condition ) or the revised email (condition ) coupled with a telephone call. the phone call was scripted to provide additional information about plasma, including how often plasma can be donated, a suggestion to donate every weeks, and a prompt to forward-book appointments. results: the final sample (n = ) comprised women ( %) and men ( %) aged - (mean = ). after two months . % of donors returned to donate plasma at least once. after controlling for gender, age, and blood group, donors in each of the intervention conditions were more likely to return to donate plasma than were donors in the bau condition. the greatest effect was found between donors randomized to condition (revised email + phone call), or = . , ci = . - . , and bau. donors assigned to the two telephone conditions (condition and ) donated plasma at a higher frequency than bau. summary/conclusions: this study tested the effectiveness of interventions designed to encourage first-time plasma donors to return to donate plasma and to establish a routine of donation. early indicators suggest that the evidence-based email and phone call elements are more effective than bau in bringing donors back to donate plasma, and the revised email combined with a phone call had the greatest positive effect on short-term plasma yield. background: healthy individuals with hereditary hemochromatosis (hh defined as hyperferritinemia and homozygous p.c y mutation), but also carriers of other hfe mutations (p.c y/p.h d or homozygous h d) with elevated serum ferritin (sf) are accepted as blood donors, if allowed by local regulations and if eligibility is fulfilled. generally, blood components are released for transfusion at normal sf levels (< ng/ml in females, < ng/ml in males). aims: prospective, two-center, randomized study comparing the efficacy and tolerability of double-erythrocyte apheresis ( rbcaph) and whole blood phlebotomy (wbph) for iron depletion in asymptomatic subjects with hh or hyperferritinemia and other hfe mutations in the setting of routine blood donation. methods: eligibility criteria included age ≥ - years, total blood volume ≥ l, bmi < kg/m , hb ≥ g/l, elevated sf levels and no end organ damage due to iron overload. rbcaph ( ml rbc) were scheduled every days and wbph ( ml) every days until sf was < ng/ml. a complete blood count and sf were measured at baseline, at every visit and at follow up weeks after completion of the study. adverse events were systematically recorded. the treatment effect was tested by poisson regression, with gender, hfe mutation, bmi and baseline sf as covariates. results: subjects ( females; mean age years) were randomized to wbph (n = ; female) or rbcaph (n = ; females). hfe mutations were p.c / p.c y in subjects, p.c y/p.h d in , and p.h d/p.h d in . at baseline, mean hb was g/l (sd . ) and median sf was ng/ml (iqr - ng/ml). procedures (wbph n = , rbcaph n = ) were completed; were interrupted (local hematoma, insufficient flow); ( wbph, rbcaph) were postponed because of low hb and for non medical reasons. there were drop-outs in the wbph arm due to depression and poor compliance, respectively. anemia (hb < g/l in males, < g/l in females) occurred after visits in wbph subjects and after visits in rbcaph subjects. fatigue was reported after phlebotomies and aphereses. only participants ( %) completed the study per protocol. blood components ( rbc concentrates and plasma units) for transfusion were obtained. overall, a median of . wbph (iqr . - . ) was needed to reach sf < ng/ml, corresponding to . times of rbcaph (median . , iqr . - . ) (p = . ). analyzing separately p.c /p.c y and p.c y/p.h d carriers, the relation wbph to rbcaph was . and . , respectively. treatment arm and hfe mutation were the covariates with significant effect on the primary endpoint (p = . and . , respectively). summary/conclusions: rbcaph is more efficient than wbph for iron depletion in healthy subjects with hh or other hfe mutations and moderate hyperferritinemia. intensive treatment schedules, generally recommended for hh, are difficult to keep because of hb drop and compliance. less intensive treatment in asymptomatic individuals with hh and their inclusion in blood donation would avoid negative effects on quality of life and benefit blood collection centers in the long term. background: serum ferritin (sf) measurements in whole blood (wb) donors demonstrated that female sex and intensity of donation are major risk factors for iron deficiency. approximately ml red blood cells (rbc) and - mg iron are lost with wb donation. double unit rbc ( rbc) collections of ml (ca. ml less than the rbc amount of two wb donations) lead to a loss of about mg iron. in switzerland, the maximal allowed donation frequency for male donors is once every months for rbc and once every months for wb donation. aims: to describe and compare the course of hemoglobin (hb) and sf in male subjects donating wb and rbc at our institution. methods: we included wb and rbc donors (n = ) who donated with the maximal allowed donation frequency over months between and , yielding , wb and , rbc donations. we excluded subjects with hyperferritinemia and known hfe mutations. hb limits were g/l for wb and g/l for rbc donation. with rbc apheresis ml rbc were collected. sf was measured on a predonation serum sample; hb was determined from finger prick samples. the donors received no iron substitution. we used generalized estimating equation models for hb and sf trajectories. results: mean age at the first blood donation was (wb) and years ( rbc), respectively. at the first donation, mean hb was g/l (sd ) in wb and g/l (sd ) in rbc donors; mean sf was (sd ) and lg/l (sd ), respectively. on average, hb and sf were higher in rbc donors ( . g/l and lg/l, respectively; p < . ). there were subjects with sf < lg/l in wb and in rbc group, and with sf < lg/l (but > lg/l) and , respectively. in rbc donors, between the first and the last donation, mean hb declined from g/l to g/l (p < . ) and mean sf from lg/l to lg/l (ns). in wb donors, mean hb dropped from g/l to g/l (p < . ) and sf from lg/l to lg/l (p < . ). similar results were found when adjusting for age and season. hb values dropped from baseline until the th donation for wb donors and until the th donation for rbc donors with an upward trend thereafter. in both groups, no hb value below the limits of blood donation and no anemia were observed. sf reached a nadir at the th donation in both wb and rbc donors ( lg/l and lg/l) and increased thereafter in rbc donors. in wb donors, sf followed a parabolic trend that peaked at the th donation, and then declined until the last donation. summary/conclusions: the maximal allowed blood donation frequency for wb and rbc male donors in switzerland is not only protective for the development of anemia, but also for deferral of blood donors because of low hb. this was observed even in subjects with low sf at baseline. background: granulocyte concentrate transfusion is a potentially lifesaving option for patients without functional neutrophils. however, recent studies have failed to demonstrate the anticipated clinical effectiveness of this procedure. granulocyte concentrates are manufactured using sedimentation agents to separate granulocytes from red blood cells and enhance granulocyte collection efficiency. high-molecularweight hydroxyethyl starch (hes) is most commonly used for this. however, authorities recently restricted the use of hes due to its unfavorable risk-benefit-profile. modified fluid gelatin (mfg) is an already used alternative sedimentation agent. as the granulocyte product contains these substances, any impact of the sedimentation agent on granulocyte function may affect the clinical effectiveness of granulocyte transfusion. aims: we tested the hypothesis that mfg is not inferior to hes in terms of the functionality and viability of granulocytes. methods: granulocytes from ten healthy donors were isolated, aliquoted and incubated in parallel for hours with either % (control), . %, % or % mfg (gelafundin %, b. braun melsungen ag) or hes (hespan %/ / . , b. braun medical inc.), respectively, and granulocyte migration, chemotaxis, reactive oxygen species (ros) production, neutrophil extracellular trap formation (netosis), antigen expression of cd b, cd l and cd b, and viability were subsequently investigated in vitro. testing was performed using live cell imaging of the cells embedded into a collagen i matrix for parallel testing of migration, ros production and netosis. in addition, flow cytometric (facs) analysis was utilized for surface marker expression, viability and respiratory burst measurement. results: granulocyte migration decreased in a dose-dependent manner in response to hes and mfg. relative to the controls, all three concentrations of hes lowered migration distances (p < . respectively), whereas only the higher concentrations ( % and %) of mfg showed lower relative migration distances (p < . respectively). track straightness was reduced with both sedimentation agents at % and % to the same extent (p < . respectively). hes resulted in lower cd b expression (p = . ) and higher cd l expression (p = . ) compared to the controls, whereas the differences for cd b did not reach statistical significance. mfg did not affect the expression of any investigated surface antigen mediating endothelial adhesion and transmigration in comparison to the controls. no significant differences in the timing of ros production or netosis, or in neutrophil viability or respiratory burst were observed. summary/conclusions: these results indicate that mfg is not inferior to hes in terms of granulocyte phenotype and function in vitro when used at equal concentrations, and that potential impairment of granulocyte function can occur with hes. background: plateletpheresis donation leads to a well-known transient decrease of donor's platelets. the question of long-term effects raised with the development of regular donations by some donors in order to satisfy a growing demand. a seminal work (lazarus, transfusion, ) stated that there is a sustained thrombopenia in frequent plateletpheresis donors, correlated with the total number of donations. aims: french regulation authorizes up to plateletpheresis donations per year, with a minimum weeks interval between them. we tried to evaluate the risk of sustained thrombopenia under these conditions. methods: we retrieved all plateletpheresis donations occurring between / / and / / from the french civilian blood donors' base and then selected a cohort of donors with at least donations during that period. in order to minimize measurement errors, platelet counts analysed were means of three consecutive donations, i.e. measures for each donor. results: the cohort includes , donors ( women and , men). mean platelet counts fluctuate between . and . platelets/ml. analysis of variance does not show any statistically significant difference (f = . ), even taking donor's sex or age in consideration. there is no difference if we consider the total duration of the donations, either. donors with the lowest first counts show a significant rise in subsequent measures and donors with the highest counts show a decrease trend, exhibiting a classical regression toward the mean. summary/conclusions: plateletpheresis french regulation does not seem to be at risk of sustained donor thrombopenia. this conclusion is in agreement with recent literature data. the primary biological role of the human leukocyte antigen (hla) system is the regulation of the immune response to foreign antigens. because of this role, hla genes and molecules have an important role in transplantation, etiology of many autoimmune, non-autoimmune and infection diseases, but also in transfusion medicine. an increasing probability of an hla non-compatible blood products, tissues or organs exists due to the extremely high polymorphism of hla genes, with more than , described alleles to date, and their different frequency distribution in various worldwide populations. the hla system, originally discovered as a result of a transfusion reaction in the s, can cause detrimental immune reactions in transfusion therapy. hla antibodies present in the patient are responsible for some of these reactions, while in other cases hla antibodies or hla reactive cells present in the transfused product are accountable for the immunoreactivity. hla antibodies form as a result of exposure to foreign hla antigens during pregnancy, transplantations and blood transfusions and can cause platelet immune refractoriness, febrile transfusion reaction, transfusion-related acute lung injury, and transfusion associated graft versus host disease. in order to avoid or reduce the development of these transfusion-related events, hla antibody negative or compatible products should be used. almost all existing methods presently used for molecular typing of hla polymorphisms are based on polymerase chain reaction, but with different resolution levels (low resolution -two digits or high resolution -four digits). in addition to providing a more precise detection of polymorphisms at hla classical loci (e.g. hla-a, -b, -c, -drb , -dqb ), molecular methods can also determine polymorphisms at hla loci which previously could not be typed by serology (e.g. hla-drb , -drb , -drb , -dqa , -dpa ). the most commonly used method for the detection of hla antibodies was until recently complement-dependent cytotoxicity (cdc) technique, but it is increasingly being replaced by a more sensitive, solid phase based method (luminex technology). in conclusion, an accurate and precise determination of both hla gene polymorphism and hla antibodies presence is essential for the safe and efficient administration of transfusion products. background: in only a minority of pregnancies complicated with anti-hpa a antibodies serious fetal/neonatal disease develops. the difficulty in predicting which mothers should be treated with ivig hampers implementation of fnait screening. we found that fc-core fucosylation and galactosylation are highly variable in anti-hpa a igg, and that these glycan features strongly affect binding to fccriiia receptor. the level of fc-core fucosylation of anti-hpa a alloantibodies was found to correlate with platelet count and outcome of the newborn, suggesting that antibodyspecific fucosylation might serve as a biomarker in fnait screening. however, at present the fc-glycosylation pattern can only be determined by complicated methods involving purification of the antigen-specific igg, and analyzing trypticly released -igg-derived-glycopeptides by tandem liquid chromatography-mass-spectrometry (ms) techniques. these methods, although powerful, are not yet suited for high throughput clinical screening. aims: our aim was to provide a simplified method to quantify the biological activity of anti-hpa- a antibodies, and possibly other alloantibodies against blood cells. methods: here we explored if cellular surface plasmon resonance (spr) imaging can replace ms, resulting in less complicated handling of patient sera and donorantigen-bearing cells. the strength of the binding of platelets to fccr on spr sensor was monitored under flow. the spr sensor was equipped with both wt fccriiia (sensitive to fc-glycosylation status) and mutant fccriiia-n a (insensitive to fcglycosylation status). in addition, the biosensor was prepared with anti-platelet cd (c ) and anti-igg to calibrate the number of injected platelet as well as to quantify igg-opsonization. the quality of the anti-hpa a glycosylation was monitored as the ratio of the binding of opsonized platelets to the wt and the mutant n a-fccriiia. platelets opsonized with recombinant glycoengineered anti-platelet antibodies with different levels of fc-fucosylation were used as standards. for validation, plasma samples with anti-hpa a antibodies, already analyzed by mass spectrometry and with known clinical outcome were tested (sonneveld, bjh, ) . results: we found that the ratio between the binding to the wt fccriiia and to the mutant n a-fccriiia correlated with the level of fucosylation of the hpa a antibodies, as measured by mass-spectrometry (r = À . ; p < . ). overall, a similar predictive value for disease severity was obtained as we previously reported for this retrospective cohort. in addition, quantitative information on antibody concentration can also be extracted using the fccriiia-n a receptor as sensor on the chip, while anti-igg gave aspecific signals, presumably because it recognized cytophilic platelet-fccriia-bound antibodies as well. summary/conclusions: in conclusion, the combined use of wt and mutant fccriiia in a label free spr assay provides both quantitative and qualitative information of platelet bound anti-hpa a antibodies, which circumvents the need for purification of specific antibodies and laborious mass spectrometric analysis. this approach might be generally applicable to determine the biological activity of cell bound antibodies not only for anti-hpa a in fnait, but also for anti-rhd alloantibodies in hdfn or anti-platelet antibodies in itp. background: immunization against the human platelet hpa- a alloantigen is the most common cause of severe fetal and neonatal alloimmune thrombocytopenia (fnait) in otherwise healthy term newborns. the screening for hpa- a antigen in pregnant women is an important tool for identification of pregnant women at risk of having a fetus/neonate with fnait. any targeted intervention depends on efficient screening methods as well as sensitive and specific methods for detection of anti-hpa- a. within the framework of the polish-norwegian project (prevfnait) we have performed hpa- a screening program in poland. aims: our aim was to assess the frequency anti-hpa- a antibody detection and the clinical outcome of newborns identified through the study. women who joined the program due to the fnait in the previous child or in the current newborn are not analyzed in this study. methods: hpa- a screening of pregnant women in - gestational weeks was performed by facs phenotyping or rq-pcr genotyping at ihtm in warsaw. hpa- a negative/hpa- b/ b women were tested for hla drb * : and for anti-hpa- a antibodies by maipa (followed up at week - , , , - and weeks after delivery). if anti-hpa- a were detected, quantitative maipa was performed. all hpa- a negative women were contacted for information concerning the newborn. if the baby had thrombocytopenia and anti-hpa- a were not detected by maipa, the look back samples were tested retrospectively by paklx test (immucor). results: hpa- a negative women were identified ( . %). anti-hpa- a was antibodies were detected by maipa in women (two delivered tweens). in addition, anti-hpa- a antibodies were later detected by paklx in further women who delivered baby with severe thrombocytopenia and/or ich. total number of immunized mothers was ( . %). they delivered babies; were boys. three women were treated by ivig: two by and injections since th and th gw respectively. the anti-hpa- a concentration in the st one was . ; . ; . iu/ml in , , gw respectively and in the nd < . iu/ml in all examined samples. the decision on treatment was based on the low plt count~ g/l in the fetus in cordocentesis. their newborns (one delivered tweens) were healthy. the rd treated woman entered the program in gw (anti-hpa- a concentration was high . iu/ml). she obtained one injection of ivig. her baby was born with mild thrombocytopenia with no ich. severe fnait occurred in / newborns: in with anti-hpa- a detected in paklx only and in with antibody concentration in maipa - st : . / . / . at / / th gw respectively; nd : . / . at / th gw respectively. ich was observed in all of them; plt count was < x in four, / in one. summary/conclusions: / the severe thrombocytopenia due to anti-hpa- a alloimmunisation in our prospective study occurred in / pregnancies / the paklx could improve anti-hpa detection in the screening program and should be considered as an additional diagnostic test, if maipa result is negative / the hpa- a alloimmunisation frequency is higher in pregnancies with male than female fetus. background: foeto-maternal platelet alloimmunization (fmpai) is mainly characterized by foetal and / or neonatal thrombocytopenia (fnait), sometimes revealed by intracranial hemorrhage (ich) or even by foetal death in utero (fdiu). the experience of the pnil milwaukee (usa) reported in that the diagnosis of alloimmunization was carried in only % of neonatal thrombocytopenia cases with a clinical symptomatology highly suggestive of an alloimmune etiology. aims: the aim of this two-year study was i) to determine the frequency of platelet incompatibilities in fnait, ich and fdiu and ii) to evaluate the frequency of detectable platelet alloantibodies (alloab) and their specificity in cases of incompatibility. methods: platelet genotyping was performed by hpa beadchip genotyping kit (bioarray solutions, immucor, warren, nj). serology investigation was carried out by different methods: complete maipa kit (apdia bvba, turnhout, belgium), pack lxtm assay (immucor gti diagnostics, waukesha, wi) and « in house » maipa. all and data were collected using the laboratory information management system. results: patient files were analyzed. no incompatibility is demonstrated in hpa- to - , - and - systems in . % (n = ). hpa- and / or and / or incompatibilities were found in cases ( . %), hpa- and / or in cases ( %). platelet alloimmunization was globally confirmed in only . % of the cases. platelet alloabs were identified regardless of clinical manifestations: anti-hpa- a ( . %), anti-hpa- b ( . %), anti-cd ( . %), anti-hpa- a and anti-hpa- b ( . % respectively) and anti-hpa- b and anti-cd ( . % respectively). alloabs were found in the context of neonatal thrombocytopenia, in ich and in fdiu, and in a follow-up of pregnancy. even if no anti-hpa- alloab could be identified, the incompatibility in this system was highly associated with fnait, ich and fdiu (n = , n = and n = on cases). summary/conclusions: this study strongly confirmed the known immunogenicity of some hpa systems and highlighted overall the severity of hpa- and hpa- incompatibilities. the definite diagnosis of fmpai is difficult to make due to the present technical difficulties in the detection of antibodies against the hpa- and hpa- systems. however, our results suggest that special attention should be paid to the management of pregnancies with these incompatibilities due to the frequency of severe foetal/neonatal adverse events. background: fetal and neonatal alloimmune thrombocytopenia (fnait) is a potentially life threatening disease caused by maternal alloantibody formation against fetal human platelet antigens (hpas), of which anti-hpa- a is accountable for the fast majority of the cases. population-based screening for fnait has been topic of debate for over decades. logistically as well as financially, the major challenge of such a screening is the typing of pregnant women to recognize the % hpa- a negative women. at present, hpa- a typing is mostly done by genotyping. for costeffective implementation of anti-hpa- a screening there is need for a high-throughput, quick and low-cost phenotyping assay. aims: the aim was to develop a high-throughput, quick and low-cost phenotyping assay in order to identify hpa- a negative pregnant women. methods: an automated sandwich elisa was developed to perform hpa- a phenotyping using a murine monoclonal anti-gpiiia as coating antibody and horseradishperoxidase-conjugated recombinant igg anti-hpa- a as detecting antibody. to ensure the applicability for high-throughput testing in a potential screening setting, ll of the uppermost plasma of - days-old stored edta anticoagulated blood tubes was used, without first swirling or spinning them. in two phases, samples of pregnant women were tested and compared to an allelic discrimination polymerase chain reaction assay as golden standard. in the first phase, samples from unselected consecutive pregnant women were tested. the second phase was part of a prospective screening study in pregnancy and confirmatory genotyping was restricted to samples with an arbitrary set od < . in the hpa- a elisa. the developed elisa was optimized to require no additional handling (swirling or spinning) of stored tubes. during phase i, consecutive samples were tested. in phase ii, the hpa- a elisa was performed in another , consecutive samples, with confirmatory q-pcr in , . the two phases combined, samples from in total , hpa- a negative and hpa- a positive pregnant women were genotyped. the assay reached a % sensitivity with a cut-off od between . and . , leading to a specificity of . %. summary/conclusions: a quick, low-cost and reliable assay for hpa- a phenotyping was developed that can be used in a population-based screening setting to select samples that has to be tested for the presence of anti-hpa a antibodies. because plasma from non-mixed or spinned tubes of three to six day-old samples can be used, this assay is applicable to settings with suboptimal conditions. background: cytomegalovirus (cmv) sero-prevalence in ireland is lower than that which is reported in many other european countries. a study of pregnant women in found that . % of irish women were cmv seropositive in comparison to % from western europe and % eastern europe and % from africa. an internal study carried out by the irish blood transfusion service (ibts) in indicated the rate of cmv seropositivity in irish blood donors was . %. therefore a significant proportion of the irish donor and recipient population are susceptible to primary cmv. this is of particular concern for patients for certain at-risk groups such as very-low birthweight cmv seronegative neonates, cmv seronegative patients undergoing transplantation and other cmv seronegative immunocompromised patients. this results in a demand for the provision of cmv sero-negative blood components. in the ibts evaluated the abbott alinity s cmv igg assay as a replacement for the cmv mastazyme eia (total ab eia). aims: to assess the performance of the abbott alinity s cmv igg screening assay in comparison to the cmv mastazyme eia (total ab eia). methods: diagnostic sensitivity was determined by testing confirmed cmv igg positive donors from an external laboratory. sensitivity was assessed using three seroconversion panels (n = ). analytical sensitivity was calculated using linear regression analysis of the who first international standard for anti-cmv igg. diagnostic specificity was determined by testing donors. further evaluation of discordant results was carried out using the architect anti-cmv igg and igm assays and vidas anti-cmv igg and igm assays. results: the diagnostic sensitivity of the alinity s anti-cmv igg assay was determined to be %. the seroconversion sensitivity reported out of samples reactive. the analytical sensitivity of the alinity s cmv igg assay was determined to be . iu/ml. the validation reported discordant results from donor samples tested with both the alinity s cmv igg assay and the current mastazyme total assay. discordant results were observed (alinity s anti-cmv igg positive/mastazyme total negative). further testing of these samples classified discordant results as positive, as negative and as indeterminate. discordant results were observed (alinity s anti-cmv igg negative/mastazyme total positive). further testing classified these samples as negative. overall the diagnostic specificity was determined to be . %. summary/conclusions: both the seroconversion and analytical sensitivities are comparable between the alinity s cmv igg assay, the cmv mastazyme total ab assay, the architect cmv igg assay and the vidas igg assay. the slight variations can be attributed to the individual assay cut-off definitions, which can vary greatly between cmv assays. it must be noted that the determination of the diagnostic specificity ( . %) does not include indeterminate discordant results. further testing will be carried out to try to characterize all discordant samples in collaboration with abbott. this evaluation did not identify any donors with isolated confirmed cmv igm antibodies in a pool of donors. based on this evaluation the abbott alinity s cmv igg assay is a suitable replacement to the mastazyme total ab assay for blood donor screening. background: africa has a unique set of challenges regarding safe blood transfusion. two of the largest contributing factors are: ) the most common disease states in sub-saharan africa (ssa) require large amounts of blood as lifesaving interventions e.g. malaria, ) the highest burden of infectious diseases transmissible through transfusion (tapko, toure, & sambo, ) is found in ssa. this has often led to the binary donor base that exists in ssa, consisting of voluntary non-remunerated blood donors (vnbd) and family or replacement donors (frd) as transfusion centres are unable to supply the demand when relying only on vnbd. voluntary non-remunerated donors are the safest blood donors as they have no incentive (other than altruistic motives) and are not under social pressure to donate, both factors that may induce individuals knowing or suspecting themselves to be infected with a blood-borne agent to donate blood. nucleic acid testing (nat) in conjunction with serological testing is the gold standard for testing, however, the vast distances and high temperatures of africa makes transport of traditional plasma samples a logistical challenge. many publications evaluating the stability, suitability, and ease of use of dried blood spots (dbs) for nat have been published. generally, results have been shown to be comparable to traditional plasma samples. dbs is being used successfully in the early infant diagnosis (eid) programs for hiv by means of pcr testing, especially in africa. aims: . to demonstrate that dbs and/or dried plasma spot (dps) testing is suitable for blood donor screening and can make nat testing more widely available in africa . to determine the diagnostic sensitivity and specificity of testing dps and dbs samples, in comparison to testing of plasma samples. methods: negative new donor samples and confirmed positive donor samples, as defined by routine blood safety screening done at western cape blood service, were screened using a dried blood spot kit. after routine testing was completed, one dbs sample and one dps sample for each blood donor were prepared and analysed with the ultrio elite assay on the panther analyser. summary/conclusions: dbs/dps can be used as a sample for screening blood donors as the invalid rate was . %, and only found on dbs samples. logistically dbs/dps is well suited for the resource-poor countries as samples are: -easy to obtain (fingerpick samples could be used.) -transport is simplified as samples will not leak or haemolyse due to high temperatures. -samples can be stored at room temperature dbs/dps demonstrated acceptable specificity. the ultrio elite performed well with regards to hiv and hcv sensitivity. sensitivity with regard to hbv was not as high but this could be due to very low and erratic viral loads. background: sanquin blood supply is responsible for the blood transfusion services in the netherlands. at the national screening laboratory sanquin (nss) annually more than . blood and plasma donations are tested, on average . samples per day. for more than years, infection serology testing was performed using the prism (abbott diagnostics), but since mid of july , serological testing for the hbsag, hiv ag/ab, anti-hcv and anti-hbc is done with abbott's alinity s system. aims: to compare the numbers of initially and repeatedly reactive results of whole blood and plasma donation samples and the rate of non-specific results leading to deferral of donations and donors for prism and alinity s assays using data from months before and months after implementation of the alinity s systems at nss. methods: initial and repeat reactive rate of the assays run by either prism (hbsag, hiv o plus, hcv) or alinity s (hbsag, hiv ag/ab combo, anti-hcv,) were calculated for january to june (prism) and august to december (alinity s). due to the lack of a true confirmatory method for anti-hbc, we only compared the rate of repeatedly reactive results for prism hbc and alinity s anti-hbc. results: the rate of repeat reactive results for prism (p) and alinity s (a) assays were as follows: ) hbsag p . % ( / . ) versus a . % ( / . ); ) hiv p . % ( / . ) versus a . % ( / . ); ) anti-hcv p . % ( / . ) versus a . % ( / . ). the rate of anti-hbc reactive samples was not significantly different between prism ( . %) and alinity s ( . %). over the study period, the rate of initially reactive samples for the three main screening assays (hbsag, hiv, hcv) was also comparable between alinity s ( . %) and prism assays ( . %), mainly attributable to a rather high number of initially reactive alinity s hiv ag/ab results. this was due to initial issues with blood collection tubes that were resolved. as a result in december, the rate of initially reactive samples decreased to . %, which was significantly lower than for the three prism assays ( . %). summary/conclusions: the introduction of the alinity s assays lead to a decrease of the average repeat reactive test results (hbsag, hiv, hcv) by . % as compared to the prism, mainly due to a lower false reactive rate of the alinity s anti-hcv assay. this will be further investigated for first time and multiple time donors. with the implementation of the alinity s at sanquin we aimed to improve not only the operational efficiency but also to further minimize unjustified disapproval of donors. these first data show that the low initial and repeat reactive rates of the alinity s assays indeed have a positive impact on unnecessary deferrals of donations and donors. background: in blood banks, testing all blood donations for markers of infectious diseases plays an important role in maintaining the safety of blood transfusions. mandatory serological testing in switzerland is performed for anti-hcv, hiv ag/ab, hbsag and syphilis. highly specific and sensitive tests with corresponding automation are essential for this purpose. aims: a comparative study was carried out to evaluate the usability of the newly launched alinity s system (abbott) and the specificity of the infectious disease parameters hbsag, anti-hcv, hiv combo and syphilis (abbott) with the currently used elisa methods on the quadriga befree system (all diasorin, formerly siemens healthcare diagnostics). methods: the study took place at the interregional blood transfusion service in berne, switzerland. the specificity of the parameters was studied on , blood donor sera from both first time and repeat donors. the samples were tested first on the quadriga be free system with enzygnost hbsag . , enzygnost anti-hcv . , and enzygnost hiv integral assays and on the pk with the newbio-pk tpha assay (newmarket biomedical). all samples were retested on the same day with hbsag, anti-hcv, hiv combo and syphilis on the alinity s. initial reactive samples were repeated in duplicate. discriminatory tests were carried out for repeatedly reactive samples using alternative screening tests and neutralisation (for hbsag) on an abbott architect i system and immunoblots (hiv-, hcv-, syphilis-inno-lia, fujirebio). for all samples, results from our routine individual donation nucleic acid testing (hcv, hiv, hbv, roche cobas system) were available. results: based on the results from testing , blood donations, the observed specificities of alinity s assays (a) and enzygnost assays ( summary/conclusions: the alinity s system was easy to use by the operators after a very short introductory training and provides good operational efficiency such as high throughput even when selective testing for samples is needed. the observed specificity of abbott alinity s versus siemens enzygnost assays is comparable in a blood donor screening setting. unfortunately, we were not able to analyse statistically the specificity data due to the insufficient number of donor samples tested in parallel. it is worth mentioning that around % of the samples included in the study derived from repeat donors who had been previously tested with the enzygnost assays but were "first time donors" for the alinity s assays. all four assays from both systems exhibit a very good specificity and are highly suitable and practicable for routine blood donor screening. background: effective screening for transfusion-transmissible infections is essential to ensure safe blood transfusions. the world health organization recommends mandatory serological testing of blood donations for human immunodeficiency virus (hiv), hepatitis b (hbv)/c (hcv), and syphilis. due to increasing demands on clinical laboratories, there is a need for reliable and accurate automated blood screening tests. the fully automated cobas e analyser can be used with elecsys â infectious disease parameters to screen donor blood samples. aims: to compare the performance of elecsys â infectious disease parameters on the cobas e analyser (roche diagnostics) with other commercially available assays for routine first-time blood donor screening. methods: we provide results from etablissement franc ßais du sang (montpellier), a blood bank which participated in a large, multicentre study of the cobas e analyser. the following infectious disease marker assays were compared: hiv, elecsys â hiv duo versus prism hiv o plus; hcv, elecsys â anti-hcv ii versus prism hcv; hbv surface antigen (hbsag), elecsys â hbsag ii versus prism hbsag; hbv core antigen antibodies (anti-hbc), elecsys â anti-hbc ii versus prism hbcore; syphilis, elecsys â syphilis versus newbio pk tpha assay. specificity was tested using residual fresh serum samples from unselected first-time blood donors, and calculated according to assay package inserts and site-specific cutoffs. samples were tested using comparator assays, then retested the same day using elecsys â assays. initially reactive samples were repeated in duplicate; confirmatory tests were conducted on repeatedly reactive samples. confirmatory tests: hiv, nucleic acid testing (nat), architect hiv ag/ab and inno-lia â hiv i/ii score assays; hcv, nat, archi-tect hcv and inno-lia â hcv score assays; hbsag, nat, architect hbsag and elecsys â /prism hbsag confirmatory assays; anti-hbc, nat, hbsag, anti-hbs, and architect anti-hbc assays; syphilis, architect syphilis tp and inno-lia â syphilis score assays. sensitivity was tested using preselected, anonymised, positive, citrate-phosphate-dextrose-plasma samples (plasmatec laboratory products) and compared with archived data for comparator assays. sensitivity was calculated according to the final nat result. results: across all infectious disease markers, specificity to detect repeatedly reactive samples using elecsys â versus comparator assays was similar ( . - . % versus . - . %; n ≥ ). in specificity analyses, there were discrepant results for hiv testing, for hcv, two for hbsag, eight for anti-hbc, and five for syphilis. sensitivity of the elecsys â hiv duo assay ( . %; % ci . - . ) was higher than the prism hiv o plus assay ( . %; % ci . - . ), but the difference was not statistically significant. sensitivities of elecsys â and comparator assays were the same for hcv ( . %; % ci . - . ), hbsag ( . %; % ci . - . ), anti-hbc ( . %; % ci . - . ), and syphilis ( . %; % ci . - . ); three hcv and six anti-hbc samples were classified negative/ indeterminate and excluded from the analyses. in sensitivity analyses, there were two discrepant results for hiv testing, three for hcv, and five for anti-hbc. summary/conclusions: elecsys â infectious disease parameters on the cobas e analyser demonstrate high specificity/sensitivity for screening first-time blood donor samples, with similar clinical performance to other commercially available assays. background: individual plasma and serum specimens from whole blood or plasmapheresis donors are tested for absence of infectious agents by serological assays prior to use for transfusion or production of blood derived therapeutics. the department of plasma analytics (pa), takeda (austria), and haema ag, grifols (germany), both labs with high throughput and a high level of automation, were seeking for alternatives to replace their current serological test systems (abbott prism next). aims: to allow a direct comparison of the two final candidate analyzers alinity s (abbott) and cobas e (roche diagnostics gmbh), a side by side evaluation was carried out by the pa and haema with support from abbott and roche (provision of instruments and reagents). the aim was to compare assay specificities as well as handling and performance of the instruments. the outcome should be used to better understand potential specificity differences and practical handling aspects (throughput, etc.) of a next generation serological analyzer. methods: the two candidate instruments were installed in the pa. from march to june , close to , aliquots from routine preselected repeat donors, provided by haema, were run on both study instruments in parallel. plasma samples were tested for hbs antigen (ag), hcv antibody (ab), hiv ag/ab, and partially for syphilis ab. serum samples were additionally tested on hbc ab. samples with repeat reactive results ("rr", two reactive results out of three tests) not confirmed by confirmatory tests were counted as false reactive. the necessary sample size was calculated based on a one-sided comparison of proportions with the aim to detect potential specificity differences (a = %) in the size of those specified by the manufacturers' instructions. two different lots were tested for the three main assays. results: out of , plasma and , serum samples, test results representing individual donations were found rr on one or both instruments. two samples were confirmed positive ( hbsag, hcv), two others were indeterminate. the sample containing low level antibodies against hcv was pcr negative and only detected by the roche system. the percentage of false reactive results for the five assays on the two systems were (alinity s/e ): hbs ag: . / . % in a total of / samples tested; hcv ab: . / . % in / , p < %; hiv ag/ab: . / . % in / , p < %; syphilis ab: . / . % in / ; hbc: / % in / . no significant difference was found between the calculated specificities in our study and the manufacturers' data. a potential influence of sample matrix and kit lots was assessed. a trend towards more false reactive results in serum vs plasma was found for nearly all assays. no clear-cut statistical difference was seen between lots. summary/conclusions: the study results are in line with the manufacturers' specificity data, showing that the alinity s hcv ab and hiv ag/ab assay show a slightly higher specificity in a population of plasma and serum samples from repeat donors prescreened by prism. a possible influence on the test specificity by the sample matrix was detected but needs further investigation. the possibility to edit complex genomes in a targeted fashion has not only revolutionized basic research but biotechnological and therapeutic applications as well. with the rapid development of genome editing tools, in particular zinc-finger nucleases (zfns), transcription activator-like effector nucleases (talens), and the crispr-cas system, a wide range of therapeutic options have beenand will bedeveloped at an unprecedented speed. therapeutic genome editing in hematopoietic cells enable new interventions in the blood and immune system, including novel approaches to treat immunological disorders, infectious diseases, and cancer. we have developed gmp-compliant protocols to manufacture gene edited cd + hematopoietic stem and precursor cells (hspcs) as well as chimeric antigen receptor (car) t cells, with the final goal to provide novel cell therapies for patients suffering from primary immunodeficiencies, chronic infection with human immunodeficiency virus type (hiv- ), and some tumor entities. despite great success in improving their specificity, engineered designer nucleases can induce genotoxic side effects by introducing mutations or chromosomal aberrations. we have established novel genome-wide assays that enable us to detect chromosomal aberrations induced not only by off-target activity but also by on-target activity, such as micro-aberrations and translocations, with unparalleled sensitivity. in toto, our developed protocols allow us to achieve genome editing in hematopoietic cells with high efficiency and to assess the genotoxic risk associated with the expression of crispr-cas nucleases and talens in clinically relevant human cells, so forming the basis for planned phase i/ii clinical studies. adoptive t cell therapy (act) has proven a potent means to treat blood-borne tumors and solid tumors. adoptive cell therapies include t cells that are genetically engineered with tumor specific t cell receptors (tcrs), or with chimeric antigen receptors (cars). in addition, tumor infiltrating cells (tils) can be isolated from tumor lesions, which are then expanded and reprogrammed in vitro prior to transfusion into the patient. the anti-tumoral efficacy of act products depends on several parameters, including the capacity of cd + t cells to produce cytokines, chemokines and granzymes, a feature that is critical for effective anti-tumoral responses. here i will discuss our efforts to develop and improve act products for future clinical use. i will present pre-clinical work on developing til therapy for non-small cell lung cancers. in addition, i will show that human cd + t cells can be divided into different subsets, and that only one of those subsets is highly cytotoxic. this finding may help improve the quality of genetically engineered t cell products, like tcr and car t cell products. background: the baltic states -estonia, latvia and lithuania have a lot in common. we are located side by side, share the baltic sea as a gate to the west, and more importantly, a common history. we were members of the ussr and suffered years of soviet occupation. we held hands in a km long human . . .chain" across the three states to express our mutual support, and later on, even joined the european union on the very same day -june st , . the three differ a bit in size, population and more in the languages spoken in each one, but that does not explain why the path towards voluntary unpaid donation varies as it does. aim: the aim is to describe the journey towards voluntary non-remunerated blood donation in the baltic states after regaining independence from the soviet union. methods: the information was collected from published and unpublished memories, annual reports and written interviews with latvian and lithuanian colleagues. results: in soviet times, all orders came from moscow and quality control was conducted from the capital city of latvia, riga. donors were mostly paid and given an extra vacation day. big factories were the best places to collect blood and people were queuing to donate. in , the soviet union fell apart and the baltic states suddenly got the freedom and responsibility to decide. in estonia the first edition of "guidelines for the preparation, use and quality assurance of blood components" was taken as guidance in . a lot of advice came from finnish colleagues. in , it was decided to move towards non-paid voluntary donations. the process took years. the first couple of years were economically difficult for the reborn state, as money had less value than food. instead of cash, donors were given rapeseed oil, sugar and pasta, for example. as the situation improved, food items were replaced by small symbolic gifts that carry sentimental value. it has been this way for more than years by now. in lithuania, the process started later, the first program for developing a framework for voluntary non-remunerated donations being carried out in - . it resulted in % of the donations being unpaid. the second program initiated in is still ongoing, aiming towards % non-remunerated donations by . by the end of , they had reached . %. in the beginning, the main obstacle was a private blood center creating unfair market conditions. in latvia, monetary compensation for blood donations still exists, but the younger generation has been encouraged to donate blood for free and some results can already be seen. summary/conclusions: a common starting point does not guarantee the same results, at least not at the exact same time. examining the circumstances leading to the different outcomes could benefit countries yet to start moving towards non-remunerated donations as well as those considering the opposite. haemoglobin (hb) was as expected significantly different between women and men (meanaesem: . ae . vs . ae . g/dl; p < . ). percentage of females with low hb < . g/dl were . %, . %, . %, . % and . %, percentage of males with hb < . g/dl were . %, . %, . %, . % and . % for the age groups - respectively. ferritin values were higher in males compared to females (median; th - th %>tile: ; - vs ; - lg/l; p < . ) and in older age groups compared to younger age groups (median; range in age groups - in females: ; - , ; - , ; - , ; - , ; - and in males: ; - , ; - , ; - , ; - , ; - respectively) . percentage of females with ferritin ≤ lg/l were . %, . %, . %, . % and . %, while percentage of males with ferritin ≤ lg/l were . %, . %, . %, . % and . % for the age groups - respectively. white blood cell counts (wbc) were slightly higher in females compared to males (meanaesem: . ae . vs . ae . ; p < . ). percentage of females with wbc > x /l were . %, . %, . %, . % and . %, while percentage of males with wbc > x /l were . %, . %, . %, . % and . % for the age groups - respectively. none had wbc < x /l. platelet counts (plt) were higher in females compared to males (meanaesem: ae . vs ae . ; p < . ).percentage of females with plt < x /l were . %, . %, . %, . % and . %, while percentage of males with plt < x /l were . %, . %, . %, . % and . % for the age groups - respectively. among the low plt counts most were caused by edta-dependent pseudothrombocytopenia. extreme deviations from normality were seldom and referred to gps for further investigations. summary/conclusions: first time donors are young with % younger than years of age and the female/male ratio was / . of the first time donors with data on ferritin available, % had low ferritin (≤ lg/l). the typical male first time donors neither had low hb nor low ferritin, even with a significantly lower ferritin in younger donors. in female first time donors the prevalence of low hb ( %< . g/dl) and low iron stores ( %≤ lg/l) is high. in all, while all first time donors are highly appreciated, campaigns could target the male population to even out the gender imbalance. blood centers must be aware of the higher prevalence of low iron stores in the youngest donors. background: the aim of assessing suitability of prospective blood donors is protection of their health and the safety of transfused patients. selection process is not always effective in obtaining all relevant information from blood donors in a timely manner. for several reasons, some risks remain undetected or they are disclosed at a future donation(s). therefore, recording and management of post-donation information (pdi) are of great importance for improvement of transfusion safety, donor counselling and education as well as overall improvement of the selection process. aims: the aim of the study was to present results of pdi management at croatian institute of transfusion medicine (citm) and the effect of education activities on their trends. methods: we have analyzed reports on pdi recorded in two-year period ( - ), according to the types of information obtained, age and sex of blood donors, total number of their donations preceding pdi, and the time of receiving the information. the effect of an information leaflet on pdi launched in november was assessed by comparing results in two study years. results: a total of pdi were recorded: in ( / donations) and in ( / donations) with the following distribution: nonsexual risk as tattoo and piercing ( . %), surgical procedures ( . %), travel history ( . %), infections/ contact ( . %), other medical reasons ( . %), endoscopy/invasive diagnostic procedures ( . %), malignancy ( . %), autoimmune diseases ( . %) and sexual risks ( . %). majority ( . %) were late pdi, revealed on the future donation(s): . % on the first next donation, . % on the second and . % after more than subsequent donations. the mean age of blood donors associated with pdi was ae years (median years), while the mean age of all donors in / was years (median years). of all pdi, . % were related to male donors ( % in total pool of citm donors). using chi-square test there were no significant difference between female and male donors in total pdi frequency and in their distribution to early and late pdi (p > . ). the median number of all donations preceding pdi was for female donors and for male donors. implementation of education leaflet for blood donors resulted in . % reduction of pdi in compared with (p > . ). the effect is more pronounced (p < . ) when comparing second and first half of (- . %). reduction is observed in all types of pdi with the exception of infections/contact (because they are mostly early pdi) and malignant diseases. the share of early pdi increased from . % in to . % in , which may suggest better awareness of blood donors on the importance to inform blood bank on changes in their health status. summary/conclusions: our study points to the importance of systematic recording and management of pdi, including education of blood donors about the need of providing all relevant facts related to their health and the safety of donated blood in a timely manner. we are planning further improvements by providing information on this topic on posters and screens on donation sites. background: currently, the transfer of data between organizations and/or computer systems is very limited, and where present is typically proprietary. in the absence of a standardized reference format individual organizations and vendors attempting to integrate disparate databases must develop unique solutions. aggregation of information from multiple sources is complex and costly, constituting a significant barrier to effective analysis of data to improve practice and inform policy. aims: to standardize the definitions and facilitate integration of key data items used in blood donation and transfusion. we report here on an initial effort to map internationally harmonized critical steps in the blood collection/donation process in order to test the approach. methods: through a collaborative process of serial conference calls and correspondence, an informal multi-national consortium of experts across the transfusion industry are attempting to create a vocabulary with sufficiently precise definitions to be usable by automated systems and that can be the foundation of a blood collection/transfusion medicine common data model (cdm), using the following steps: -define the scope of activity to be addressed and segment into key processes. -identify the set of data elements in each segment that are common to all systems. -review and consider existing standards and definitions for each data element. -develop draft definitions for each data element. -release draft to public domain for critical review and refinement with long-term goal of gaining widespread endorsement. results: a standardized approach to blood donation was mapped through identification of common pathways and core mappable data elements. denominator data associated with donor characteristics and blood collection was selected as the first segment to address. a dictionary (or vocabulary) of common terms has been created and will be presented for international comment. summary/conclusions: developing an international consensus on the core elements and their definitions across the transfusion chain is critical for data integration and automation efforts. the expected benefits of this endeavor include that it allows the establishment of algorithms to automate reporting and thus reduce hands-on staff time; reduces time and resources needed to integrate new databases; allows systems to continue to use existing concepts and definitions internally while also providing data output in a standardized format; supports the ability to consistently analyse, interpret and present information regardless of the data source; establishes data definitions against which new systems can be developed; helps to improve comparability of results by providing a common data model for researchers and policy makers; improves confidence in data integrity and reliability of the derived information as a © the authors vox sanguinis © international society of blood transfusion vox sanguinis ( ) (suppl. ), - basis for rational decision making; and reduces data gathering effort and cost thus improving opportunities for more efficient/complex data analysis. standardizing the transfusion medicine dataset is the first step in achieving the automation of data transfer and analysis needed globally to drive patient safety, research innovation, and best business practices. further steps must address the precise methods of data exchange, identification of responsible entities for maintenance and further development, and engagement of computer system developers. red blood cell (rbc) alloantibodies develop in a subset of individuals following exposure to non-self rbcs through transfusion, pregnancy, or other activities; these antibodies can lead to difficulty locating compatible rbcs, acute or delayed hemolytic transfusion reactions, or hemolytic disease of the newborn. alloimmunization is underestimated due in part to antibody evanescence, the random nature of posttransfusion antibody screens, fragmented medical care, and the lack of widespread antibody registries. factors that influence who will develop detectable alloantibodies are not well understood. transfusion burden is one risk factor for alloimmunization, though many highly transfused individuals never form alloantibodies despite exposure to many rbc units (and many non-self abo blood group antigens). individuals with sickle cell disease (scd) and myelodysplastic syndrome (mds) are more likely to form rbc alloantibodies than most other patient populations. individuals with rheumatologic and other forms of autoimmunity, though not chronically transfused, are also at higher than average risk of forming rbc alloantibodies. inflammation, in a broad sense, is one common thread among these diagnoses associated with high prevalence rates of rbc alloimmunization. reductionist murine models support some types of inflammation (including viral-like stimuli) around the time of rbc exposure as being associated with an increased likelihood of alloantibody formation. strategies other than transfusion avoidance or extended antigen matching beyond abo/ rh would be beneficial to prevent new rbc alloantibody formation, especially in patients at highest risk. background: the unique genetic makeup of the omani population makes them rich in the genetic blood disorder. % of omani populations are Àa/Àa gene carriers, % Àa/aa, and % of the population are aa/aa. around % of omani nationals carry the gene for hbs, and - % carry the gene for b-thalassaemia. recent statistics show that there are around patients with thalassaemia major and with scd in oman. the other rbc abnormality that is common in oman is g pd deficiency which is found in % of males and % of females. omanis are known to have the highest frequency of a thalassaemia and g pd reported so far in any race. although blood transfusion is one of the supporting treatments of scd, it can cause some serious complications for the patients. alloimmunization of red blood cells is one of the consequences of blood transfusion. alloimmunisation of the rbcs can cause haemolytic transfusion reactions and may trigger hyperhaemolysis, in which transfused and patient's own rbcs are destroyed. alloantibodies can cause delay in the process of transfusion, it can be costly and time consuming. high number of patients developing alloantibodies may indicate a major difference in the patient and donor population. it may also indicate lack of a controlled, generalised sickle patients management policy. in oman the decision of transfusing scd patient is left to physicians attending the patient. aims: this study is aimed to highlight the increasing number of alloimmunised sickle cell patients. in the royal hospital we get new cases of sickle patient with alloantibodies each year. the acknowledgement of these cases may help in is assessing the current practice of transfusing scd patients, or will help to define the donor and patient population difference. methods: patients were recruited in the royal hospital for this study. edta blood samples were taken for antibody screening test and in the positive cases antibody was identified, all tests done by capture technique using immucor neo machine. results: of the scd patients, % of the patients were male and % female, mean age was years, in the range of - years. % of the scd cases were positive for the alloantibodies, % were female and % were male, the age range was from - years. % of the positive were scd, % s trait and % were s/ bthal. most of the patients developed one antibody, however cases of multiples antibodies were also detected. % of the patients were with single alloantibody, % of them with two antibodies, % with three antibodies, % with four antibodies and % with five antibodies. the majority of the cases were igg against rh antigens anti-e is being the majority %, followed by anti-d %, anti-k %, anti-c %, anti-c %, anti-jk a %, anti-jk b %, anti-fy a %, anti-e %, anti-s %, antis %, anti-kp a . %, anti-fy b . % and igm being %. summary/conclusions: rbc alloimmunisation rate is high in oman majority of the patient affected are female. interestingly sickle trait patients were also transfused and % of them developed alloantibodies. the practice of transfusing rh and kell matching blood unit is implemented four years ago and still high alloimmunization percentage is achieved. background: in ghana, routine pre-transfusion investigations for patients with sickle cell disease (scd) involve only abo-d typing and immediate spin crossmatch, without screening for irregular rbc antibodies aims: determine the prevalence and specificities of and risk factors for rbc alloantibodies in multi-transfused patients with scd methods: in , a cross-sectional study in multi-transfused patients with scd, from two tertiary hospitals in ghana was performed. participants' data on demography, transfusion and medical history were recorded. antibody screening and identification tests were done at sanquin, the netherlands, with standard serology using liss as enhancer and with papain treated rbc panel cells ('enzyme only'). characterization of rhd genes was done by multiplex ligase amplification assay. logistic regression was used to determine the association of patient characteristics, i.e. sex, age at enrollment (continuous), age at first transfusion (categorized as ≤ , - , - and ≥ ), previous pregnancy, number of transfused units ( , - and - and > ), and years after last transfusion (< , - , - , > y) with presence of alloantibodies results: patients ( males and females, median age years, range . - ) were included. the median number of transfusions was (range - ). the median years after last transfusion was (range weeks- . years). in patients, anti-rbc antibodies were detected. in of them the antibodies were weakly reactive with enzyme treated cells only or pan-reactive, possibly some of them representing autoantibodies or antibodies against high frequency antigens. in seven patients enzyme-only anti-le a was demonstrated, likely naturally occurring antibodies. thus, in at least patients ( . %) alloimmunization was demonstrated or suspected; in patients the alloantibodies were 'enzyme only'. besides, the alloantibodies of known specificity ( anti-d, anti-d+c, anti-e, anti-c, anti-e, anti-k, anti-s, anti-le a , anti-go a ), three antibodies reactive only with fy(a-b-) cells and two antibodies of yet unidentified specificity were detected. in six d-patients ( had been pregnant) anti-d (together with anti-c in two patients) was found. in three out of four d+ patients with anti-d, an rhd variant gene was demonstrated ( dau-alleles and diii type or diva- ). logistic regression revealed that none of the risk factors analysed was associated with the presence of antibodies in the patients. immunobiology -red cell alloimmunity fifty-eight patients, had experienced an adverse reaction during or shortly after transfusion ( patients had dark urine). adverse reactions were associated with the number of units received (or . ( % ci, . - . ; p = . ), but not with the presence of antibodies (p > . ) summary/conclusions: in at least % of multi-transfused patients with scd alloimmunization could be demonstrated, mainly ( %) directed against rh antigens. the enzyme only reactivity, coupled with absence of antibodies in seven of patients with probable haemolytic reaction and known evanescence of especially non rh antibodies suggest possible low titre and disappearance of some clinically relevant antibodies. given the high immunization rate together with the high frequency of adverse transfusion reactions, pre-transfusion screening for rbc antibodies should be considered for patients with scd. background: rh blood group system and mainly antigen d is one of the most immunogenic, diverse and clinically important protein-based blood group. antibody anti-d may induce hemolytic transfusion reactions and hemolytic disease of the fetus and newborn. anti-d prophylaxes become ineffective if an anti-d immunization has occurred. approximately % of the d+ population carries rhd alleles associated with reduced d antigen expression. qualitative variants, in which some epitopes are lacking and can produce anti-d antibody, are usually termed partial d. by contrast, d weak is commonly defined as a quantitative variant that have all d epitopes and should not make anti-d. del is a very weak form of d antigen and cannot be detected by routine serological tests. because some of del individuals have already developed an anti-d antibody whereas others did not this group contains both qualitative and quantitative changes. aims: investigation was prompted by finding discrepant results in typing of d antigen in a pregnant woman / rd pregnancy, st delivery, abortions in st trimester/. routine serological techniques detected d negativity and the presence of antibody allo-anti-d in clinically significant titre. the non-invasive testing of d status of the foetus from maternal peripheral blood was indicated, but this was not applicable due to presence of the rhd gene in the woman's dna sample isolated from buccal swab. our aim was to investigate the discrepancy and determine the underlying rhd genotype. methods: blood samples, dna from peripheral blood and buccal swab of the pregnant woman were investigated. routine blood grouping and antibody testing were performed by column agglutination. two anti-d sera (id-diaclon anti-d igg (cell line esd ) by biorad and anti-d duo igm+igg, clone: th + ms by immucor) were used for adsorption/elution test for identification of del phenotype. initial rhd genotyping was performed by rt-pcr (exons , , ) with the dna from buccal swab; further resolution was performed using pcr-ssp (fluogene; inno-train diagnostik gmbh); sequencing was performed by sanger analysis (inno-train diagnostik gmbh). results: genotype was identified as rhd positive by ce-certified pcr-ssp kits (fluogene). sanger sequencing of rhd from exon to revealed presence of a nucleotide deletion in position c. dela, which is specific for allele rhd* el. . this nucleotide change results in the amino acid change p.val leufs* causing the del phenotype. presence of antigen d was proved by adsorption/elution technique. titre of the anti-d was rising during the pregnancy to the level two weeks before the delivery. the newborn was delivered by s.c. without a sign of hemolytic disease. blood grouping of the newborn revealed blood group a, d negative, dat negative, testing for del was not performed. summary/conclusions: the case reported here shows that females with rhd* el. allele are able develop strong anti-d immunization, so this type of del phenotype belongs to the "partial del subgroup". presence of variant rhd gene in mother disabling antenatal fetal genotyping from maternal blood by current methods requires a more attentive approach to care for such pregnancies. supported by mh cz-dro uhkt and rvo-vfn . a-s - ea scharberg , s rothenberger , a st€ urtzel , n gillhuber , s seyboth , e richter , g rink and p bugert institute for transfusion medicine and immunohematology, drk-bsd ba-w€ u-he, baden-baden institute for transfusion medicine and immunology, heidelberg university, medical faculty mannheim, mannheim, germany background: rb a (di ) is a low prevalence antigen of the diego blood group system. it has been found in few families only. the clinical significance of anti-rb a is unknown so far. the slc a *c. c>t (p.pro leu; isbt allele name: di* . ) allele is the molecular basis of the rb a antigen. in the gnomad database this gene variant was found in only one of , sequenced genomes (allele frequency: . ). aims: to prove the frequency of the allele in our population and gain an rb a positive donor we performed a molecular screening for di in , blood donors. after our antibody screening test accidentally contained an rb a positive test cell we found out that anti-rb a is a very common antibody specificity. the frequency of the antibody in patients and blood donors was proved. methods: for the molecular screening of the blood donors we developed a pcr-ssp method. the antibody screening test in , patients and in blood donors was performed in the gel technique (biorad ahg id-cards) using a cell screening panel (drk-bsd src) including an rb a positive test cell. positive reactions with the rb a positive cell were confirmed by an additional rb a positive test cell of different source. additional antibodies were excluded or identified in the same method using an antibody identification panel (drk-bsd irc). results: the molecular screening for the di* . allele in , blood donors revealed no single positive individual. within the first weeks of usage of our antibody screening test which accidentally contained the rb a positive test cell patients with anti-rb a were found. it was . % of , patients tested in laboratories in different parts of germany. some laboratories stopped using the rb a positive lot to avoid expensive and time consuming identification and conformation tests. in of randomly tested blood donors ( . %) anti-anti-rb a was also present. summary/conclusions: despite the very low frequency of the di* . allele, anti-rb a is a very frequent unexpected antibody in patients and blood donors in germany. it is obviously naturally occurring and is even more frequent than anti-wr a and anti-vw we found in previous studies in around % of patients and donors. a-s - national blood center, ministry of health and sports, yangon, myanmar hemovigilance which detects every event not only for patient' reactions and donor's complications but also incidents and near misses definitely improve quality of blood transfusion services especially for those situations where implementation of all the standards in one time is not possible. healthcare system in myanmar is still in the stage of requiring priority for clinical professions and has limited resources for supportive roles. supportive services including transfusion service are still not a center of interest from prioritization of health care system. blood transfusion service has been practiced in myanmar since . real essence of transfusion service is hidden behind laboratory practice and transfusion is regarded as part of laboratory investigation. hospital laboratories take care of testing of blood donated by replacement donors. this kind of transfusion services under laboratory umbrella is still being practiced in myanmar except national blood center (nbc) which was established in in accordance with blood and blood product law. this law was formulated cohesively with who strategies of blood safety. in , who global data-based study sent questionnaires for assessment of safety status of transfusion service. nbc noticed that there was no data which can support corrective actions for safety. from that time onward, active retrospective review of existing data and introduction of records, prospective finding of process errors and any events from hospital blood banks were recorded and taking into actions at local level. cost of every unit of blood is supported by government. in , national blood and blood product committee was established. the steering committee is working hard to get cooperation from every service by aiming to prevent those undesirable events before establishment of national level policy, standards and guidelines for sustainable service quality. in conclusion, by using essence of hemovigilance as a tool, quality of transfusion service can be improved step by step to fulfil the gap in spite of limited resources. the system started in local, extends to regional level by getting agreement of importance from hemovigilance results and is finally approaching to national level endorsement. background: erroneous transfusion of abo-incompatible(aboi) blood almost always reflects a preventable breakdown in transfusion protocols and standard operating procedures and can have disastrous consequences, with significant morbidity and mortality. these incidents need to be investigated in a systematic manner to identify system vulnerabilities to mitigate risks and improve patient safety. since , reporters to shot have been asked to score( - ) the extent to which the cause of incidents can be attributed to key factors: staff, environmental, organisational and government/regulatory which helps recognise the key factors identified whilst investigating these incidents. aims: to understand why unintentional transfusion of aboi blood components continue to happen despite standard procedures and national guidance available. methods: retrospective analysis of unintentional transfusion of aboi blood components reported to shot between - (inclusive) was done to identify common themes and recognise areas of improvement. information provided using the shot human factors investigation tool (hfit) between - was reviewed to understand more about why the errors occurred. results: sixty-seven unintentional aboi transfusions were reported between - ; majority ( / , . %) were red cell transfusions but aboi plasma ( / ) and platelet transfusions ( / ) were also seen. most errors occurred in the clinical area ( / , %), and could have been detected at point of administration. in ( %) cases, the error could not have be detected at the point of administration with a primary laboratory error in / ( %) incidents. reviewing data from hfit for cases in - ( aboi cases), the total score for staff culpability was , compared to a total score of for all the other three organisational and system factors. this disparity is most obvious for the aboi red cell cases, all of which scored the maximum for staff culpability, i.e. / compared to / as the combined total score given to the other factors. in the preceding years ( to ), there were no hf scores available; however, the emphasis on staff-related culpability is demonstrated by cases that included an outcome of the local case review and ( . %) mentioned staff-related retraining or disciplinary procedures. the risk of haemolysis and serious harm is more likely with aboi red cells than with other components with / ( %) that resulted in death, / ( %) major morbidity and / ( %) no or minor adverse reaction. of these cases, one resulted in conviction for manslaughter and at least two staff dismissals. summary/conclusions: transfusion never events continue to occur, and it is evident that investigations into such incidents focus mainly on staff failings and do not consistently identify system wide changes that need to be incorporated to address prevalent issues. national recommendations and a safety alert to 'use a bedside checklist' immediately prior to administration were issued between - to support prevention of such errors but never events continue to persist. current approach is ineffective because it often leads to apportioning blame, rather than understanding the often-complicated and multidimensional factors contributing to the error. this must be replaced by a holistic approach which addresses local work pressures and embraces advances in automated technology like electronic prescribing and barcode scanning. of the confirmed trars, n = were possibly related to treatment, n = trars were probable, and n = were definitely related to treatment; n = trars were grade , n = were grade , and none were grade . in recipients of conventional wb, there were n = ( . %) ars, n = ( . %) fnhtrs, n = ( . %) taco, n = trali, and n = ( . %) unclassified transfusion reactions. of the confirmed trars, n = were possibly related to treatment, n = trar was probable, and n = were definitely related to treatment; n = trars were grade , n = was grade and n = was grade . there were mirasoltreated wb transfusions in pregnant women and trars ( . %), both grade and probably related. there were transfusions of mirasol-treated wb and transfusions of conventional wb in patients < years old resulting in n = ( . %) trars in recipients of mirasol-treated wb and n = ( . %) in recipients of conventional wb. summary/conclusions: timely data reporting of trars and expanding the hv infrastructure has helped to improve the hv system in ghana. of wb transfusions in routine use in ghana, there were . % trars in recipients of mirasol-treated wb and . % in recipients of conventional wb. additionally, mirasol-treated wb was safely transfused in pregnant women and pediatric patients. haematology, monash health, melbourne, australia background: transfusion-associated graft-versus-host disease (ta-gvhd) is rare and usually fatal. it can be prevented by provision of irradiated blood products to at-risk individuals, such as those receiving nucleoside analogues, alemtuzumab, bendamustine or with hodgkin lymphoma (hl). duration of risk is uncertain, so ensuring these individuals correctly receive lifelong irradiated blood components, as currently recommended by anzsbt and bsh guidelines, is challenging. in australia, platelets are routinely irradiated, but red blood cells (rbc) are not. aims: to determine whether patients receiving fludarabine, cladribine, bendamustine, alemtuzumab, or dacarbazine (for hl), appropriately received irradiated rbcs. secondary outcomes included rates of ta-gvhd after unintended exposure to non-irradiated components, factors influencing correct issue of irradiated rbcs such as transfusion management plans, and provision of adequate clinical information on blood requests. methods: we performed a retrospective audit to identify patients receiving therapies indicating risk for ta-gvhd using pharmacy dispensing records from january to october at monash health, a multi-campus university hospital in melbourne, australia. diagnosis, treatment dates, group and hold (g&h) requests, rbc transfusions, and follow-up information were sourced from laboratory and medical records. results: we identified patients who received fludarabine (n = , %), bendamustine (n = , %), cladribine (n = , %), dacarbazine for hl (n = , %) and alemtuzumab (n = , %). the median age of patients was years (range - ) and ( %) were male. median follow-up was months (range - ). post-exposure, patients ( %) received transfusions with % correctly receiving irradiated rbcs. the remaining , all from haematology/oncology, received a total of unirradiated rbcs. in patients, this was rectified on subsequent transfusions. there were no cases of ta-gvhd at median follow-up of . months (range - ) from first rbc transfusion. after medication administration, patients had g&h requests after a median of months (range - ). only % of requests had sufficient clinical information to prompt irradiation, such as hl or medication details, and only % asked for irradiated components. preventive strategies have now been employed. transfusion management plans for haematology patients were implemented in march . for audited patients, these were written from days prior to days after medication exposure. two were written following inadvertent unirradiated rbc transfusion. patients identified in this audit will have a laboratory flag generated and prospectively, pharmacy dispensing records will be sent to blood bank to identify at-risk patients. our hospital is transitioning to electronic medical records (emr). an alert will be generated in emr when ordering transfusions if there has been exposure to these medications. however, clinical awareness and documentation remain vital. additional measures include patient education, alert cards, and ongoing collaboration with medical staff to encourage transfusion planning. summary/conclusions: recognition of patients at risk for ta-gvhd remains low, even among haematology units. we are making progress on ensuring provision of lifelong irradiated blood components in patients exposed to nucleoside analogues or alemtuzumab, as well as hl patients. implementation of an emr and additional strategies in this domain is important to prevent ta-gvhd. background: blood transfusion is considered an essential element in the management of patients globally. it might be risky and transfusion related adverse reactions may occur with the less adherence of transfusion policies. standard guidelines regarding the screening of blood for infectious disease, genuine need of transfusion and abo compatibility are followed and monitored drastically. however, patient assessment during transfusion especially at patient bedside and post transfusion is also equally important. aims: we are a newly established hospital and are working towards the best possible management of patients. in this regard to minimize the transfusion errors and to highlight if any lacking being practiced during transfusion, we conducted this study to observe the compliance rate of documentation of transfusion form by the healthcare staff and also to observe the compliance of line of action taken in case of occurrence of transfusion reactions. methods: this was a observational study conducted at nibd and bmt, pechs campus from february to february . ethical approval was obtained prior to the study. transfusion form for each transfusion was filled. the form provided information on documentation of blood product receiver name, employee identity number, date and time of receiving blood product, patient name, medical record number on units, on patient's wrist band and on transfusion form. abo compatibility on the unit and on form, medical record number from wrist band, name and employee identity number of two healthcare staff started transfusion, transfusion start and completion time. time, temperature, blood pressure, pulse and initials of staff at the time of order, onset, after minutes and at the completion of transfusion were also included. transfusion reaction form was also filled by the healthcare staff. data was analyzed by using spss version . . results: a total of transfusions forms were analyzed. over all compliance rate was %. out of , ( %) forms were available in source notes and of , ( %) were partially and completely filled. higher compliance was seen in the initial months of hospital establishment than later months (p-value = . ). highest non compliance was seen in documentation of initials of duty doctors on transfusion form at the completion of transfusion( %) and highest compliance was seen in documentation of name by healthcare nursing staff at the start of transfusion( %). a total of ( . %) adverse events were reported from red blood cells and platelets. mean time of start of symptoms was hours and minutes for red blood cells and for platelets it was hour and minutes. transfusion was instantly stopped as the symptoms appeared with no delay of time and actions were taken to resolve the reactions. time of appearance of symptoms and time of start of medication were documented and error free. all blood bags were returned to the blood bank and discarded after hours as per the policy of hospital. summary/conclusions: the study was conducted to highlight the scarce practices that are being implemented by healthcare staff in context of documentation and reporting of transfusion reactions at our hospital. stringent actions should be taken for the adherence of compliance by healthcare staff to avoid morbidities and mortalities. we believe that it will also be helpful to provide baseline information in the process of preparation of a national guidelines and protocol on blood transfusion procedures. a-s - as buser, a holbro and l infanti regional blood transfusion service, swiss red cross, basel, basel, switzerland to make blood supply safer, pathogen inactivation (pi) technologies have been developed. they are based on photochemical (amotosalen/uva or riboflavin/ uv) or uv-c light treatment to reduce potential pathogens in blood components. this gain of safety might however be offset by "off target" effects of these technologies. in virtually all clinical platelet transfusion trials, it has been demonstrated that post transfusion increments with pi platelet (plt) components are lower as compared to conventional components, indicating different biological behaviour such as survival/ clearance of nontreated and treated plt. published studies have also suggested shorter survival of platelets in vivo in animal studies. additionally, data of the rates of alloimmunization and refractoriness after transfusion of pi platelets are show discrepant results. animal studies suggest a reduction of the rates of alloimmunization when transfusing (leukoreduced) pi plt as compare to conventional plt. in the clinical setting, published data, including very recent reports, showed different rates of hla class i and ii alloimmunization with the two currently available photochemical based pi technologies. while pi of plt components surely benefit patients regarding pathogen safety, the impact of potential off target effects possibly impairing efficacy of pi plt transfusions need more investigation. background: brucellosis is an endemic disease and still a major health problem in saudi arabia. ministry of health in saudi arabia listed brucellosis as a notifiable disease due to its endemicity. in the last ten years, the incidence has decreased significantly to approximately cases per , but is still higher than that in developed countries. human-to human transmission is extremely rare including breast feeding, transplacental, sexually and blood transfusion. five cases of brucellosis through blood transfusion have been reported in the literature. brucella transmission through blood transfusion is likely underreporting due to the long incubation time of - weeks (range, days to months),vagueness of clinical presentation and lack of hemovigilance systems in endemic areas. (allohsct) and ( . %) autologous (autohsct) hsct patients, with mean corrected count increments (cci) of . , . and . , respectively. mean cci decreased in a linear fashion between day ≤ and day pcs ( . , . and . at ≤ days; . , . and . at days, respectively), although the number of pc transfused on day to autohsct patients was small (n = ). background: nipah virus (niv) is a paramyxovirus (genus henipavirus) that emerged in the late s in malaysia and has since been identified as the cause of sporadic outbreaks of severe febrile disease in bangladesh and india. niv infection is frequently associated with severe respiratory or neurological disease in infected humans with transmission to humans through inhalation, contact or consumption of niv contaminated foods. nipah virus (niv) belongs to the list of pathogens identified by the who to have the potential for a global pandemic. aims: this study aimed to investigate the efficacy of the theraflex uv-platelets system to inactivate niv in platelet concentrates (pcs). the theraflex uv-platelets system (macopharma) uses uvc light without the need of any additional photoactive compound. methods: plasma reduced pcs from bcs ( % plasma in additive solution ssp+) were spiked with virus suspension ( % v/v). pcs (n = , ml) were then uvcirradiated on the macotronic uv machine (macopharma) and samples were taken after spiking (load and hold sample) and after illumination with different light doses ( . , . , . and . (standard) j/cm )). the titre of the niv (malaysia) was determined as tissue culture infective dose (tcid ) by endpoint titration in microtitre plate assays on vero cells (atcc â crl- tm ). the results of the infectivity assay demonstrated that uvc irradiation dosedependently inactivated niv. after spiking a niv titer of . (bag no. ) and . (bag no. ) log tcid /ml was received in the pcs. at a uvc dose of . j/cm and higher niv was inactivated down to the detection limit of the system ( . log tcid / ml), resulting in log reduction factors of ≥ . (bag no. ) and ≥ . (bag no. ). summary/conclusions: our results demonstrate that the theraflex uv-platelets procedure is an effective technology to inactivate niv in contaminated pcs. vs. ae . e platelets/unit, p < . ), whereas the platelet content of apheresis pc did not change ( ae . vs. , ae . , p = . ). summary/conclusions: pathogen reduction resulted in the transfusion of older pc on average, but without altering the number of pc ordered or the use of pc per patient. pathogen reduction has improved pc stock management without an increase in platelet demand, despite lower platelet content of buffy coat pc after pr implementation. donors and donation -donor adherence -are we doing the right thing? the transfusion procedure is the last step in a multi-process supply chain. the task of matching supply with demand requires donor managers to consider average consumption rates on a weekly or monthly basis, but to also have insight into variability in order distribution and possible attribute (blood groups) requirements. since hospitals and blood banks are usually not deeply interwoven and often only ex-post data is available, forecasting methods should be implemented. a thorough analysis of order pattern to set weekly target inventories and safety levels is required to close the information gap. a collection plan needs to identify possible bottlenecks which can be prevented through the planning of inter-shipping, changes in message urgency and building of reserve donor pools. constant analysis of collection and mobilization kpis allows donor managers to implement the rolling-wave planning approach and continually adapt to changing requirements, unexpected events and overall systematic variability. the variability happens on the demand side, as order quantities and their attributes, such as blood group distribution, are subject to change. however, also the supply is subject to significant variation, as donor response rates, attrition, deferrals and overall availability of donors are not constant. the data was collected with the face-to-face interview method right after the donation. first-time donors has attended to the study in regional blood centres in cities in turkey. the survey included items in accordance with the standard tpb predictors of attitude, self-efficacy, and intention. self-identity, anticipated regret, donation anxiety, paraphernalia anxiety, personal moral norm, descriptive norm, satisfaction, motivation also assessed for the first-time donors. the relation between the predictors and intention confirmed with correlation analyses. the predictors' distribution analysed by multiple linear regression. a number of goodness-of-fit indices were calculated and examined for each tested models (ibm, amos spss). the results of goodnessof-fit tests for proposed model provided a better fit to the data than these models (cmin/df = ). moreover, this result indicated that the fit between the proposed model and the data could be improved with further modifications with the inclusion of paths between motivation and attitude, self-identity and intention. moreover, inclusion the paths between donation anxiety and intention and between self-efficacy and attitude, on contrary to recent analyses suggesting opposite paths. evaluation of goodness-of-fit tests showed good result for revised model with a value of cmin/df = . , close to perfect fit. the revised model revealed that attitude was the strongest positive direct predictor of intention followed by personal moral norm, self-identity, motivation and anticipated regret (path coefficients: . , . . . , . , and . , respectively). donation anxiety was the negative direct predictor of intention (- . ). satisfaction was the strongest positive indirect predictor of intention via attitude and followed by self-efficacy ( . and . ). paraphernalia anxiety was the negative indirect predictor of intention (- . ). descriptive norm did not show any significance. our model accounted for . % of the variance in intention. summary/conclusions: these findings suggest several potential avenues for enhancing donor retention. the results obtained with this study provide important data from the standpoint of donor retention, which should be, implemented in the future strategies of turkish red crescent. background: transpose-transfusion and transplantation: protection and selection of donors, is a european consortium project, including partners from countries, reviewing donor selection and protection policies for substances of human origin (soho).one of the main issues in the current donor selection system, which transpose aims to tackle, is that for many, if not most criteria, is not evidence based. the transpose consortium therefore tries to re-assess selection criteria, revised them where needed and provide recommendations as evidence-based as possible. transpose additionally adds to the current european directorate for the quality of medicines & healthcare (edqm) guidelines by emphasizing donor safety. aims: the aim is to compare existing donor eligibility criteria throughout europe, and to compile a list of risks to consider, with evidence-or consensus-based deferral criteria to provide more uniform donor screening criteria. methods: there are three horizontal work-packages (wps); wp coordination, wp dissemination, and wp evaluation of the project, and four technical ones with specific deliverables and milestones to be regularly produced: -wp inventory of donor selection & protection practices; -wp development of risk-based guidelines for donor selection and protection; -wp development of a standard donor health questionnaire (dhq); -wp training course/workshop on the use of the guiding principles, guidelines and the dhq. the transpose project launched in september and will complete in spring . wp has completed its work in october, wp will complete its work in june , and wp and wp have recently commenced. results: with the use of the deliverables created by wp , we have created an indepth inventory of current practices in donor selection and protection, including overview of similarities and differences across european countries and across soho types. there is an agreement amongst experts that existing guidelines are often based on the precautionary principle rather than on risk assessment. consequently, in the development of wp 's guidelines for donor selection and protection, we now make an effort to also emphasize donor safety, in a more evidence-based way via the use of risk-based assessments. this will result in a standardized dhq with a common trunk and more in -depth questions per soho. summary/conclusions: the impact of the outcomes of transpose will be threefold. first, outcomes are expected to be of help in revising donor selection and protection related eu directives. second, the set of guiding principles and donor selection & protection guidelines will facilitate eu member states to take a next step in implementing donor selection and protection policies in a consistent and clear-cut way to the benefit of both donors and recipients of soho. third, a standard donor health questionnaire with carefully guided local/regional/national adjustments will become available per soho which can be used widely and will consequently enable comparisons of the prevalence of certain risks and risky behaviours throughout europe. background: transpose-transfusion and transplantation protection and selection of donors is a european consortium project, including partners from countries, that reviews donor selection and protection policies for blood, plasma, tissues, assisted reproductive technology (art) and stem cells (together soho). donor selection criteria (dsc) in europe are based on eu-directives, guidelines and countries' own additional criteria. literature shows that particular criteria are outdated or not risk-based, often leading to unnecessary donor deferral or an underestimation of risks for donors. aims: to ) provide a comprehensive inventory of current systems for selection and protection of donors and donations, ) critically review them and ) recommend an over-arching donor health questionnaire (dhq) including all necessary criteria currently used by different eu-member states (eu-ms). methods: in-depth semi-structured interviews with key stakeholders in blood collection were conducted to identify main topics for improvement in the current dsc. these formed the basis for a survey sent to professionals from collection institutions of all soho to get feedback on current systems from as many eu-ms organisations as possible. questionnaires were sent to a total of experts ( blood; plasma; tissues; stem cells; art) and ( %) completed questionnaires were received. where information was lacking, additional experts were asked to recommend upon dsc. results: for blood and plasma donation four main areas of concern in dsc were identified: risk-based selection, adaptability, flexibility and consistency. the stakeholders agreed that dsc are often outdated and lack evidence, hence leading to unnecessary deferral of donors and underestimated risks for donors. they suggested to base dsc on group risk-assessment (risk-based selection) and on conducting more research to achieve standardized risk perceptions and evidence-based deferrals, either for safety of recipient or donors. criteria could be made more detailed to fit specific groups to defer less donors (adaptability). furthermore, implementing criteria was considered easy, but abolish criteria when not regarded as a risk anymore seems almost impossible (flexibility). additionally, deferral periods are perceived too long, seen as both negative, i.e. jeopardizing donor return intention and positive, i.e. no risk for safety (consistency). changing legislation into guidance was an often-mentioned suggestion to improve dsc. specific feedback on plasma donations revealed that many whole blood topics are not applicable to plasma-only donors, e.g. parasite infections such as malaria (no deferral needed); travel history (no deferral needed), and recent bacterial and viral infections (deferral periods currently too long). a clear need for more research on plasma collection-related issues was identified. summary/conclusions: dsc are perceived redundant on a substantial number of aspects by most stakeholders. besides achieving the goal of save and sufficient soho for patients, many regulations could be improved to diminish deferrals and decrease donor risks. transpose will add to reviewing, improving and harmonising these regulations and criteria. furthermore, transpose will provide suggestions to improve directives and guidelines and a dhq, focusing on both donor health protection and safety of donations, but also removing deferral criteria that are not relevant (anymore), and offer a future research agenda to make dsc more evidence-based. background: transpose -transfusion and transplantation: protection and selection of donors, is a european commission co-funded project with participation of stakeholders from both not-for-profit and private blood collecting organizations as well as researchers and officials. the project aims to create new evidencebased donor selection criteria as well as guiding principles for risk assessment of threats to the safety of all substances of human origin (soho) except solid organs. as part of this, an inventory of current donation-related risks was performed, including an investigation of both type and number of adverse events reported. aims: we here aim to present an overview of reported adverse events in plasma and whole blood donation in europe and to compare this to the anticipated risks rated by transpose stakeholders. methods: national or local data on adverse reactions from the years - , both serious and mild, in whole blood and plasma donors was collected from the relevant stakeholders (eighteen and nineteen respectively). stakeholders were also asked to grade the most important anticipated donor risks according to severity, level of evidence and prevalence. we then compared the relevant risk categories as evaluated by the stakeholders with the categories of the provided data, as well as the heterogeneity of category numbers. results: thirteen stakeholders provided data on adverse events during whole blood donation in a given year, including in total thirty-three different categories of adverse events, ranging from only one unspecified reaction to seventeen different categories, with an average of nine categories per stakeholder. the most frequently used categories were hematoma (included by %), arterial puncture ( %) and nerve damage ( %). vasovagal reactions were also frequently included ( %); however, this was being done variably as vasovagal reactions unspecified, and acute and/or delayed vasovagal reactions. only one stakeholder reported iron deficiency. for plasma donation, seven stakeholders provided data on adverse events. a total of twenty-seven different categories were reported, ranging from one to seventeen per stakeholder, with an average of nine. the most frequently reported adverse events were hematoma ( %), citrate reactions ( %) and arm pains and nerve damage (both %, respectively). anticipated risks in blood donation were rated by nine stakeholders rating iron deficiency, vasovagal reactions and hematomas the greatest risks to donors. for plasmapheresis, six stakeholders rated vasovagal reactions, hematomas and citrate reactions as highest risk. summary/conclusions: as shown, categories used to describe adverse events in blood donation vary tremendously across europe, with some countries only being able to provide total numbers of adverse events without further specification. furthermore, there is a gap between perceived high donor risks and reported adverse reaction categories in donor vigilance for whole blood, as reports on iron deficiency are virtually absent despite being considered the most significant risk. our findings show the need for international collaboration on creating an international standardized donor vigilance system, to gather more insight into donor risks to protect the health of donors. plenary session -a glimpse of the future pl- - modern transplantation medicine has made significant progress within the last decades due to a better immunological understanding of rejection and advances in immunosuppression. however, the severe side effects of long-term, typically lifelong, immunosuppression and the shortage of donor organs remain the major restrictions in transplantation. the idea behind all research to improve transplant outcome has always been the modification of the recipient's immune system to ideally induce a specific tolerance towards the donor's graft. in fact, the immunological blindness of the recipient towards the donor's graft is achieved by a general reduction of the immune system's competence and represents a major burden for transplant patients. the idea of invisible organs is an entirely different approach to solve the problem: instead of inducing an immunological blindness of the recipient's immune system an immunological invisibility of the donor's organ is created. this is achieved by genetically engineering the transplant to eliminate the organ's immunogenicity defined by the gene products of the major histocompatibility complex (mhc) and minor histocompatibility antigens. in addition to manipulating the expression of mhc genes required for immune recognition, immune cloaking strategies are used to evade immune rejection. these approaches take advantage of creating an immunosuppressive environment and expressing immune suppressive molecules by immunomodulatory transgenes. mhc engineering and immune cloaking in an entire organ is achieved during ex vivo perfusion by lentiviral transduction of gene expression modifiers and transgenes to induce a permanent immunological invisibility of the organ. importantly, mhc engineering also prevents the presentation of minor histocompatibility antigens, which usually are not possible to match between donor and recipient, but which trigger potent immune responses and graft rejection. eliminating the targets of cellular and humoral rejection as well as creating an allograft-specific immune environment through immune cloaking camouflages the organ and equips it with a powerful set of defense weaponry. immune-engineering of transplants achieved during the inevitable ex vivo period of the allograft after explantation without the need to accept off-target effects allows keeping the recipient's immune system fully functional and capable to combat infections and cancer. in pre-clinical in vivo studies from rodents to minipigs a clear survival advantage of ex vivo engineered transplants could be demonstrated. this approach has the potential of eliminating the burden of organ rejection and immunosuppression, thereby sustainably increasing transplant survival, organ availability and quality of life. gene editing for sickle cell disease: re-expression of the fetal c-globin genes (hbg / ) could be a universal strategy to ameliorate the severe b-globin disorders sickle cell disease (scd) and b-thalassemia by induction of fetal hemoglobin (hbf, a c ). we have previously identified bcl a erythroid enhancer sequences, marked by hbf-associated common genetic variants, that are required for repression of hbf in adult-stage erythroid cells but dispensable in non-erythroid cells. recently we have optimized conditions for selection-free on-target crispr-cas editing in human hscs as a nearly complete reaction without detectable genotoxicity or deleterious impact on stem cell function. we demonstrate that cas :sgrna ribonucleoprotein (rnp) mediated cleavage at core sequences of the + bcl a erythroid enhancer results in highly penetrant disruption of gata binding motif, reduction of bcl a expression, and induction of fetal c-globin. erythroid progeny of edited engrafting scd hscs express therapeutic levels of hbf and resist sickling, while those from b-thalassemia patients show restored globin chain balance. moreover we find that hscs preferentially undergo nonhomologous as compared to microhomology mediated end-joining repair. nhej-based bcl a enhancer editing approaching complete allelic disruption in hscs appears to be a feasible therapeutic strategy to produce durable hbf induction. in this presentation, i will compare and contrast bcl a enhancer editing to other autologous curative gene therapy and gene editing approaches at various stages of clinical and pre-clinical evaluation. oxygen is vital for life. without oxygen death is assured for aerobic organisms. although everybody knows this fact a lot of medical acts forget to take care of it, leading to a lot of potential troubles. indeed, during cell respiration the glucose oxidation by oxygen gives carbon dioxide, water and energy. this energy also called atp is necessary for cellular metabolism and consequently for life. we have identified an extracellular hemoglobin coming from a marine worm, called arenicola marina, which is able to deliver oxygen to this animal living in the intertidal areas on the atlantic coast in france between the north sea and biarritz. this molecule called m was developed in the medical device named hemo life â . we have showed that this product was very efficient to protect organs before transplantation. a multi centers clinical trial performed under the supervision of pr. le meur from the chu of brest, on patients waiting kidney grafts showed a delay graft function reduced roughly by three between the two kidneys harvested on the same donor with and without hemo life â and grafted on recipients. in , a world first was realized in france by the pr. lantieri to georges pompidou hospital in paris, france. indeed, it was the first time that a patient received a second graft face. this surgery was realized with hemo life â and showed a very nice result according the pr lantieri, the anastomosis were very easy and no edema was observed. furthermore, we have developed dressing incorporating m making a product called hemhealing â . preclinical data on diabetic mice showed an increase of healing process. hemoxycarrier â , a therapeutical oxygen carrier, is also in progress of development in order to address ischemic diseases such as the sickle cells disease, myocardiac infraction and stroke. this universal oxygen carrier without blood typing, which is the ancestor of our red blood cell containing hemoglobin showed that it is able to deliver oxygen at different biological levels, cellular, tissues and organs and could address a multitude of medical applications. background: main goal of transfusion is saving life and/or improve the health status of human by "safe blood" which needs regular, voluntary, unpaid blood donors. donor recruitment is being more sensitive and challenging part of the blood supply system in actual global socio-economic conditions. achievement to enough voluntary non-remunerated blood donation (vnrbd) can be established by an efficient donor recruitment. efficiency of the donor recruitment has still close relation with blood donor recruiter although there are so many new tools. occupational specifications, rights and responsibilities of blood donor recruiter have wide range differences between countries which cannot be explained completely by the specific conditions of each country. also, a concrete document which has an international consensus was not existing on this subject. turkish blood foundation (tbf) has been organizing an international workshop since ; anatolian blood days (abd). "who is a blood donor recruiter?" was the topic of abd-vii at - march . aims: main aim of the workshop was to check and evaluate the existing systems of the participant countries. than create a model for clearly defining occupational specifications, responsibilities and rights of blood donor recruiter. methods: experts from countries participated in the workshop. those countries are albania, algeria, bosnia-herzegovina, estonia, france, germany, hungary, india, kazakhstan, lithuania, macedonia, montenegro, oman, portugal, qatar, romania, russia, saudi arabia, serbia, slovenia, sri lanka, tajikistan, turkey, uganda, uzbekistan. these countries reflect almost all religious, ethnical, social, cultural and economic situations of the world. a questionnaire which was analyzing existing systems at participant countries sent before the workshop. after country presentations different discussion groups were organized. below listed topics were announced at final declaration. results: donor recruiter: . should have university degree preferably in marketing and business administration field. . should have a certificate and/or professional experience in public relation . should have efficient skill in conversation, sociability, independence, self-confidence, reliability, resilience and conscientiousness as well as to work in a team . should get a special training which includes not only social topics such as public relation, marketing, etc. and medical topics related bb&tm before practicing alone as a donor recruiter . should be a permanent staff . should have basic salary and performance bonus might be given . is eligible to monitor and modify mobile team working period at blood drive . should participate the mobile blood drive which he/she has organized . should participate the group who will create promotional materials for national blood service . number at each blood establishment should be defined based on annual blood collection such as staffs for , whole blood collection annually in germany. summary/conclusions: in conclusion; both donor recruitment and retention are not easy tasks to undergo while public are aging, and birth rates are decreasing all around the world. dedicated blood donor recruiter whose occupational specifications, rights and responsibilities are clearly defined will be the corner stone of the success for providing enough safe blood for transfusion. ct smit sibinga and j emmanuel background: africa is a large continent with independent states and a total population of , , , (february ) . healthcare policies and strategies are developed through who's advocacy, guidance, and support from hq in geneva and the who regional offices; eastern mediterranean regional office (emro) supporting arabic speaking countries and the african regional office (afro) responsible for sub-saharan countries. population distribution is approximately . % urban. there are a large number of different local dialects and languages spoken. the main languages spoken are english, french, portuguese, spanish and arabic. countries are mainly classified by undp as being of low and medium human development index the africa society for blood transfusion (afsbt) has members in most countries, advocates for the development of sustainable and effective blood services, and has developed a stepwise level accreditation program. in emro held a consensus meeting developing a "strategic framework for blood safety and availability for - " with a set of priority interventions focusing on leadership and governance, cooperation and collaboration, provision of safe blood and blood products, appropriate clinical use of blood, and quality system management. in all member states of the african union (au) countries, in abuja, nigeria, pledged that national budget for health should be at least % of the national fiscal budget. in ministers of health of who member states endorsed that blood and blood products be included in the essential medicines list; these endorsements and who's universal health coverage (uhc), have yet to be fully implemented. aims: to analyze (gap-analysis) to what extend countries in africa implement the world health assembly resolution wha . on availability, safety and quality of blood products, which urges governments to ensure safe, accessible, affordable and available supplies of blood and components from voluntary non-remunerated blood donors, which meet clinical transfusion requirements and achieve national self-sufficiency, following who guidelines and recommendations. methods: to provide an overview of the current status of the blood supply in africa strengths and weaknesses, data from who's global status report on blood safety and availability were analyzed and used. the study has been descriptive and explorative. results: the report identified a number of areas requiring attention; principle amongst these were -inadequate funding; -lack of governance and leadership; -ineffective public education on blood donation; -absence of capacity building for clinicians on rational use of blood; -lack of haemovigilance and implementation of quality management systems; -the need for regulatory or oversight mechanisms. summary/conclusions: national authorities should address areas requiring attention if progress towards ensuring a sustainable safe and sufficient supply of blood products is to be achieved. key is the commitment and support of national governments, which should implement resolutions and recommendations agreed by ministers of health at wha and african union. background: the core function of the blood donation testing (bdt) laboratory is to screen every unit of blood collected from a donor for blood group type and infectious disease markers to ensure safety of the national blood supply prior to transfusion. the lab operates daily on two work shifts, comprising of staff on the morning (am) shift (from : to : ) and staff on the afternoon (pm) shift (from : to : ) on weekdays and staff on the am shift and staff on the pm shift on weekends. bdt lab has a staff strength of to be rostered for the work shifts. each staff is on a five-day work week and has to work pm shift and am shift per month on average. the higher number of pm shift leads to staff feedback that they do not get sufficient time in the evenings for family and social or leisure activities. a lean six sigma project was initiated to review the work rostering to improve the work-life balance of the staff. aims: the project aims to reduce the number of staff working on the pm shift without affecting the downstream processes and continues to meet the timely release of blood supply to the hospitals. methods: lean six sigma tools were used to study the bdt lab workflow process and to identify factors that contributes to the higher number of pm shifts that the staff has to take on. data on the turn-around time and the man-effort required for each screening tests performed was analyzed. a survey was also conducted to understand the preference of the staff on the acceptable number of pm shifts per month. results: the main contributing factor for more staff required to perform the pm shift is due to majority of the daily donation samples being received only in the evening. as this factor is beyond the control of the bdt lab, redeploying work from the pm shift to the am shift was eventually selected as the solution to reduce the number of staff needed for the pm shift. the screening test that was shifted was determined based on the test system that has the shortest turn-around-time and is able to allow continuous release of results. at the same time, most of the staff must be trained for that test system. a trial on the new roster involving staff on am shift and staff on pm shift was conducted. the total number of pm shift per month was reduced from to using the re-defined process. the % reduction translates to fewer number of pm shifts that the staff has to undertake and was able to meet the staff's expectation. summary/conclusions: with the adoption of the new process workflow, bdt lab was able to reduce the number of pm shifts that the staff needs to be rostered using evidence based process improvement method. most importantly, the lab has a satisfied team of staff with better work-life balance. background: preparedness of blood transfusion services for emergencies and crisis situations is an important issue concerned with patient and transfusion safety. aims: having an experience of delay in blood component supply in an emergency situation due to partial interruption of hospital information system (his), it is aimed to create a crisis kit and constitute an alternative work flow for emergency in crisis situations. methods: it is stipulated that the failure of his which is normally conducts all process for transfusion would be disabled in a disaster or crisis situation. a brain storm was made on possible challenges associated with disability of his during transfusion emergencies. according to the scenarios a kit was developed for the process management of transfusion emergencies. results: a flow chart was designed in proper with transfusion emergency definitions of who and instructions were written to explain the flow chart. all forms categorized with different colour codes are designed to fill with handwriting. the kit consists of flow chart and instructions, analysis request forms (blue coloured), blood component request forms (pink coloured), proceeding forms (green coloured), pens and blood sample tubes with edta were put into a plastic folder labelled as transfusion emergency disaster & crisis (tedc) kit. additionally, the kit is placed in a sealed clear plastic bag and delivered to all inpatient and intensive care units of pediatrics and pediatric surgery. a training programme concerned with transfusion emergency situations and usage of the tedc kit was developed for health care workers involved in blood transfusion process. pre and post-assessment tests were developed for the evaluation of effectiveness of the training programme. summary/conclusions: it's challenging to improve the response capacity of blood transfusion services during emergencies and crisis situations. abstract withdrawn. background: india is a developing country having licensed blood banks majority have manual documentation which causes inaccuracies and errors in blood bank activities. monitoring is a herculean task. computerisation is the need of the hour but this goal involves many hurdles and challenges aims: the aim of this study is to discuss the challenges faced during computerisation of blood bank activities and the remedial solutions for it methods: department of transfusion medicine, king george medical university, lucknow is one of the biggest blood bank of the country with annual collection of , blood units. two years ago, the blood bank worked on totally manual system. computerisation involved challenges associated with hardware and software installation and personnel training. hardware was installed in two phases. initially hp system but later shifted to apple imac due to frequent breakdowns. with hp server. software installation (easy software) involved erratic internet connectivity hence changed to lan. customisation involved radical changes according to our needs. at times we had to change our way of working to suit the software. biometrics linking, medical registration, cash id generation, donation, serological crossmatch, automated blood grouping, labelling, chemiluminescence & nat testing, blood component preparation and camps were all included with challenges at every level. remedial actions were taken from small to big. training of the staff was the most essential part of the implementation of computerisation who initially showed considerable resistance and at time faking ignorance due to apprehension that their mistakes will be highlighted and they will be penalised for it. it was a herculean task in creating their password protected identity and enforcing them to use it. gradually the staff realised that computerisation made their task easier as it cut down on paper work and repetition and also prevented serious mistakes from happening. hard copies at certain essential areas were still maintained to continue work in the event of major breakdown of computer results: computerisation aided us in regulating the movement of the donor which at times was repetitive due to manual entry. transfer of data ensured a safe supply and the mistakes could be retraced very easily. implementation which included installation, training and enforcement took a period of months. after overcoming all the challenges we minimised hard copies to registers and started taking printouts of the other necessary details. the turnover time for the employees due to computerisation decreased by %. waiting time for attendant decreased by %. traceability of all the units became %.supervision of the activities being carried out was % accurate. identification of the donors was easy due to biometrics which included thumb impression and iris scanning. the decision making time for donors decreased by % thus making the system more efficient. summary/conclusions: manual to computerisation involves involvement from source to supply and it is essential to anticipate the challenges and be prepared for solutions in order to make its implementation successful p- ct smit sibinga , y abdella and f konings iqm consulting, zuidhorn, netherlands who eastern mediterranean office, cairo, egypt background: who defined essential medicines (ems) as medicinal products that satisfy health-care needs of the majority of a population. they should be available at all times, in adequate amounts, in appropriate dosage forms, with assured quality and affordability. in blood and blood products (whole blood, red cells, platelets, plasma, and plasma-derived products) were added to the who model list of ems. appropriate and effective regulatory framework (legislations, regulations, etc.) and a functioning regulatory authority (ra) is crucial for management of blood products as ems. however, particularly in the less developed world, these prerequisites have barely been implemented. aims: to analyze and advise on existing legislation and regulations. existing legislative instruments of the member states of who eastern mediterranean region (emr) were collected and analysed for relevance and appropriateness for preparation and use of blood and blood products as well as use of associated substances and relevant medical devices. a literature search was done on matching combinations of regulatory system, regulatory framework, legislation, regulation, with production and use of blood and blood products, which resulted in almost exclusively references with respect to national and international legislation. benchmark: who recommendations (aide m emoires) and eu directives. methods: existing legislative instruments of the member states of who eastern mediterranean region (emr) were collected and analysed for relevance and appropriateness for preparation and use of blood and blood products as well as use of associated substances and relevant medical devices. a literature search was done on matching combinations of regulatory system, regulatory framework, legislation, regulation, with production and use of blood and blood products, which resulted in almost exclusively references with respect to national and international legislation. benchmark: who recommendations (aide m emoires) and eu directives. results: various formal legislative documents of only / countries are put in force by governments [ (egypt) till (pakistan -sindh)]. most are detailed descriptions of ra, operational establishments, and specific requirements. however, none of these legislations complies with who and eu recommended formats and contents, and will not support effective regulatory oversight to promote and enhance quality, safety and availability of these ems. summary/conclusions: government should provide effective leadership and governance in developing a national blood system (nbs, fully integrated into the national health-care system. essential functions of a nbs include an appropriate regulatory framework with legislations, regulations and other non-legislative instruments administered by a ra. these documents should spell out principles and cadres, standard setting, and organization of the blood system to ensure an adequate supply of blood and blood products and safe clinical transfusion for which a model was designed. the structure of nbs will depend on organization and level of development of the health-care system. however, all critical activities within nbs should be coordinated nationally to promote uniform standards, economies-of-scale, consistency in staff competency, quality and safety of these ems, and best transfusion practices. key is formulation of an appropriate regulatory framework administered by a ra responsible for regulating the vein-to-vein chain in the preparation and use of these ems. background: the capacity of blood transfusion service to provide adequate supplies of blood components is the issue of concern for health providers worldwide; longer term observations of trends in this respect are therefore of crucial value. aims: the study aim was analysis of some basic activities of the polish blood transfusion service in - including organizational changes, numbers of donors, donations and blood components as well as activities directed at increasing their safety. methods: retrospective analysis of data supplied by the regional blood transfusion centers (btcs). results: in the discussed period, blood and blood components were collected in regional btcs and local collection sites as well as during mobile collections. although the number of local collection sites decreased from in to in in favor of mobile collections, which increased from , to , , the former is still the number one location for donating blood. on average . % of all donations were performed in local collection sites. the total number of blood donors both at the beginning and the end of the discussed period was similar ( , in and , in ); over % of all donors were non-remunerated. however, the number of first-time donors dropped significantly (from , in to , in ). the total number of donations increased from , , in to , , in ; most frequent were whole blood collections (from , , in to , , in ) . some blood components (mostly plasma and platelet concentrates) were also collected by apheresis. most frequently prepared blood components were red blood cell concentrates -rbcs ( , - , , units per year), fresh frozen plasma -ffp ( , , - , , units) and platelet concentrates -pcs ( , - , units, with significant increasing tendency). additional processing methods such as leukocyte depletion and irradiation were more frequently applied to pcs ( - . % in respective years irradiated, . - . % leukocyte-depleted), than to rbcs ( . - . % irradiated, . - . % leukocyte-depleted). in , the pathogen reduction technologies in plasma and the pcs were implemented. up to date however the use of these technologies is limited in most btcs. in approximately . % of pcs and % ffp units issued for transfusion were subjected to pathogen reduction technologies. summary/conclusions: our study data may contribute to the assessment of some long-term tendencies observed in polish blood transfusion service and may serve practical-benchmarking. this in turn may prove beneficial to the transfusion community as a whole. background: in poland % of hospitals depend on blood for the treatment of patients; over . mln units of blood components are annually transfused. it is therefore purposeful to expand the knowledge on factors impacting on blood transfusion service (bts). the institute of hematology and transfusion medicine (ihtm) as competent authority is responsible for collection of data related to the activity of all polish blood transfusion centers (bcts). this data is exploited to a much lesser degree than the recently available statistical methods and data processing tools would allow. moreover, survey of research in the field of public health indicates a negligible share of issues related to bts. it seemed therefore necessary to "fill in the gap" with true assessment of performance of the polish bcts for improvement of bts activity. st stage of our investigation refers to collection, merging of data from different sources, their unification and preparation (big data) for further analysis to be performed using multidimensional statistical analysis and data mining methods. aims: assessment of the activity of the polish btcs over the year-period in two stages. goals at st stage: . data digitalization; scanning of paper documents. . development of a uniform template for collecting digital data from various sources. . standardization, unification and quality improvement of available data: filling in missing data, elimination of errors, duplicate records etc, that may distort the outcome of analyzes. . selection of data for analysis. methods: digitalization and big data methods for processing various types of data: a) stored in paper form ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , b) digital stored in two file types (.doc and .xls, for the years - and - , respectively). for each data-type, a separate excel file model was created. the models were then merged into one analytical table with data processing methods. results: . pages of paper documents were scanned. . models developed for data from different sources: a. paper-data were rewritten and ascribed to its model; outcome - tables, columns, , rows. b. .doc and .xls. filesdata were ascribed to other models; outcome - tables, columns, rows. . the models were merged into analytical table to create a mb database (comparable to approx. min of music). . the data was subjected to standardization, unification and quality improvement: filling in missing data, elimination of errors and duplicate records that may distort the results of analyzes. . selection of data for analysis at nd stage. summary/conclusions: the st stage provided a set of selected data for analysis in the nd stage which will rely on multidimensional statistical analysis and data mining methods. the outcome of such analysis will contribute to optimal realization of objectives: a) gaining in-depth knowledge about the fundamental phenomena that shape polish bts, b) identification of potential changes bcts, c) development of overall guidelines for change management. aimed to touch untouched or less touched topics of bb&tm. so far workshops were organized and each year around countries were participated from almost all religious, ethnical, social, cultural and economic situations of the world. . supported realization of major changes in bb&tm in turkey; a convincing medical individuals and agencies mainly moh to give the deserved consideration to bb&tm b encouraging the recognition and establishment of national blood program c issuing a new blood act and numerous necessary bylaws, etc. d creating an appropriate standard donor questionnaire form e changing blood transfusion practice from % whole blood (at ) to %. f changing donated blood screening criteria; while anti-hcv screening became obligatory malaria, screening cancelled g preparing national guidelines h promoting haemovigilance nurse post i promoting patient blood management . around , blood bankers attended national courses, , attended national congresses, , attended nationwide symposiums. summary/conclusions: bbtst can be accepted as a sample how a scientific nongovernmental organization may give a very positive impact on developing and progressing bb&tm activities with close collaboration moh and other related organizations abstract withdrawn. background: globally there is growing investment in information technology (it) in business. this similar trend has been observed in blood establishment computerized systems (becs). the it investment can be high hence it decisions need to be properly informed. the africa society for blood transfusion (afsbt) encourages the use of its in african blood services as this optimize quality blood services, thereby improving patient's outcomes. afsbt established in an it working group (afsbt itwg) with the support of the swiss red cross (src) to spearhead the it standards among member blood services. a number of priority it thematic areas were identified. these includes it governance which focuses on creation (strategic alignment) and preservation (risk management) of business value. there is absence of published literature on how a structured it governance framework can be implemented in a resource constrained setting. a review of the national blood service zimbabwe (nbsz) it governance was done based on published it governance framework. aims: to explore how a structured it governance can be developed, implemented and monitored in a resource constrained setting. methods: a published mit-cisr framework which has six components was used to assess the strength, gaps and opportunities of the it governance. results: nbsz has been implementing an evolving structured it governance system. in terms of service strategy and organization there is a well-established it function which is reflected in the nbsz strategic plans. this ensures it annual budgetary support, which averages . % of the total budget. the it governance arrangements are such that decision rights are assigned to different it staff (executives, it specialist, and users). a range of it solutions have been embedded within the nbsz operations such as becs, financial, donor mobile application, social media, temperature monitoring, and human resources. the business performance goals are defined and are congruent across the various business units. it organization and desirable behaviors are documented in the ict policies and procedures and were needed remedial actions are available through the code of conduct. the it metrics are included within the nbsz monitoring and evaluation system which use a four colored traffic lighting reporting system. it was noted that the it accountabilities are undesirably tilted to the it specialist only hence some ict projects tend to have delayed deliverables. the it governance mechanisms are supported with tools such as service level agreements and established communication approaches. simple excel based solutions are used to track critical performance metrics such as on the interactive blood supply management status, which averages . % ( ) based on a -day projected stocking and supply levels. nbsz need to properly document the return on investments on all these ict initiatives, which is estimated ( / ) to be at . % of annual savings. summary/conclusions: blood services in resource constrained settings can implement a properly structured it governance and this will ensure maximum return on it investments. the nbsz approach will be shared and further developed in the afsbt itwg to support other blood services in improving their it governance. haematology/blood transfusion, alfred health, melbourne, australia background: in october , an integrated electronic medical record (emr) was implemented at an australian metropolitan multi-campus heath service using cerner millennium tm , aiming to achieve himss (healthcare information and management systems society) level . prior to implementation, large numbers of blood specimens were collected from patients unnecessarily and sent to pathology without a test request attached (no blood test requested -ntr). these specimens required additional processing in the laboratory. electronic specimen collection using cerner specimen collect tm allowed streamlining of specimen processing by eliminating paper requests. as part of the new workflow, individual specimen labels are printed with the specified blood test and correct tube type. this helps prevent the practice of collecting additional specimens due to uncertainty of the collection requirements. aims: • to quantify the expected reduction in ntr specimens following introduction of electronic specimen collection, and outline the benefits • to determine the impact on collection errors and wrong blood in tube (wbit) events methods: data was obtained directly from cerner millennium tm using a ccl (cerner command language) query which is run monthly by pathology it staff. this data includes all specimens registered for the month with indication of rejected specimens, wbit & ntr samples. 'rejected specimens' includes incomplete specimen and/or request certification, unlabelled specimens/requests and mismatched specimens. further information about wbit events was collated from riskman reports and staff interviews. results: data from the months prior to emr implementation was compared with months post. ntr numbers reduced from /month to /month ( % reduction), freeing up more storage space in fridges. rejected specimens due to inadequate patient request labelling reduced from a mean of /mth to /mth. wbit numbers have increased slightly: before having median (range - ), after with median (range - ). although it was hoped that wbit incidence may reduce with the new emr, of the post implementation wbits involved electronic specimen collection. departure from planned protocols involving a lack of working printers, causing staff to print patient labels away from the patient's bedside, as well as multiple patient labels printing on individual printers appear to be a main cause of the emr wbits. summary/conclusions: emr implementation has led to a reduction in ntr, and rejected specimens due to inadequate request labelling, as well as increased storage space in laboratory refrigerators. associated benefits include: • decreased financial costs of the wasted equipment • decreased staff time collecting and processing unusable specimens • decreased environmental impact of manufacture and disposal of unused specimens • decreased potential of iatrogenic anaemia work in preventing the occurrence of further wbits is ongoing, by ensuring that label printers are in working order, are in plentiful supply and easily accessible to staff; and also ensuring positive patient identification and blood collection by the patient's bedside remains a priority. jm mustaffa , k teo , s tsai , p heng , r sagun and m wong laboratory medicine khoo teck puat hospital, singapore, singapore background: khoo teck puat hospital (ktph) is a -bed general and acute care hospital, opened in , serving more than , people living in the northern sector of singapore. the blood bank of ktph department of laboratory medicine provides specimen testing and blood transfusion services for ktph as well as the neighbouring yishun community hospital (ych), one of the largest community hospitals in singapore providing intermediate care for recuperating patients including rehabilitative services. the process of ordering transfusion-related test requests in both hospitals is through printed forms. aims: in line with the hospital directive to move towards electronic patient management, the ktph blood bank intended to implement an electronic type and screen (e-t&s) system. the goal of the project is to ensure zero patient identification errors and maintain full traceability and accountability for the blood collection process in all transfusion-related testing. another aim of the system is to reduce repeated venepunctures when specimens are rejected due to missing essential patient information on the printed forms by implementing mandatory fields in the e-t&s form. methods: the e-t&s was implemented in phases. phase : an online version of the printed form was signed electronically by the ordering doctor and a witness within the electronic medical record system, sunrise clinical manager (scm) system with the doctor counter-checking by signing on the specimen label to ensure correct patient identification. phase : the ordering doctor is not required to sign on the specimen label since fingerprint biometrics are required for the electronic signin. phase : elimination of the witness step for blood collection. specimen collection and rejection data from to was analysed. specimen rejection rate was presented as percentage of rejected specimens (mislabelled, unlabelled and clerical errors) over total specimen count for each month. results: between january and march , before the implementation of the e-t&s phase , the average rejection rate for blood bank specimens was . % and . % for identification and clerical errors respectively. during phases and of implementation, rejection rate increased due to unfamiliarity to the new work processes. by february , with the implementation of the final phase of the e-t&s system the specimen rejection rate was . % and . % for identification and clerical errors respectively. rejected specimens were mostly from the few locations that had to use paper requisition due to workflow or infrastructure limitations. summary/conclusions: the e-t&s system was implemented successfully in ktph. full traceability and accountability of the blood collection process was maintained with the fully electronic system. the adoption of electronic documentation has also reduced the number of preventable repeated venepunctures that were due to incomplete order information on the printed forms. future developments in technology and full implementation of e-t&s system in all hospital locations may make zero patient identification error achievable and ensure transfusion safety in all patients in the near future. background: blood component administration represents a critical phase due to the possible occurrence of errors during the different steps from the identification of the patient to the infusion of the product. error occurrence can be reduced by the implementation of validated information systems. we tested the scweb â system at the bedside in a transfusion outpatient clinic. aims: the aim of the study is to validate a system designed to assist and to control blood administration step by step using electronic devices to ensure traceability and documentation of the process methods: the scweb â system is based on it monitored checklists which guide the personnel to follow the procedure, according to best practices; the system must initially be activated by the operator which is recognized by an auto-signing system based on bluetooth low energy which avoids the operator having to identify himself/herself beforehand. appropriate privacy protection is provided. thereafter the system takes up the task to give instructions and to verify the adherence, by asking an active confirmation of the proper fulfillment of the activities; a continuous registration and documentation is made by the system. standards and specifications for each step of the procedure have been configured on scweb â system to track in detail operator and patient identification, presence of informed consent to transfusion, blood pressure, pulse and temperature recording, vein access, verification of the blood unit. an alarm has been set after min, to ensure the control of patient's conditions. for each step, an active confirmation of the action is required and nurse and doctor direct involvement must be actively confirmed on the device by both operators. the system has been tested at the bedside on patients admitted to the outpatient clinic for red cell concentrate transfusion; compliance of the personnel and organizational impact has been recorded. results: the system required a very short training: ease of scweb â system allows its implementation without negative impact on organization of transfusion outpatient clinic and without difficulties by operators (nurses and doctors), who appreciated the help given by the it check system. the registration of the electronic check list offered a reliable tool for the traceability of the transfusion procedure, also granting a paperless and timely available documentation of the entire process through a registration in electronic format of all the operator's action in every single phase of the transfusion process. when prescribed, confirmation of the checklist was only possible in the presence and with the active confirmation of two operators (doctor and nurse). summary/conclusions: the scweb â system is useful as a barrier against the mismatch of transfusion (preventive measure), as a traceability and documentation measure and as a tool for training of personnel in blood transfusion administration; it avoids paper registration during the transfusion process, due to the timely registration of the activities performed by operators recognized by the system thanks to the bluetooth low energy auto-signing device. the scweb â system will be connected to the transfusion data management system, to monitor all the process from the arrival of the unit from the blood bank. background: he blood banks aims at reducing cost and increasing customer satisfaction by providing quality in service. the quality in service can be attained by streamlining the processes and restructuring the supply chain of the organization by implementing it tools. aims: aim is to understand the complex flow of information and processes within the supply chain of the blood bank. the requirement of such a study is a part of the integrated erp modeling for the integrated functioning of a blood bank. methods: he approach used to understand and map the sequence of processes, and the work responsibilities of each process and the operational decisions involved at each step is process mapping and data flow diagrams for front end system modeling and analysis. the processes are mapped and represented in a schematic diagram. dfd (data flow diagram) are constructed for representing the system. a context diagram is also constructed for understanding the entities interacting with the system. the emr systems aim at replacing (or supporting) the paper based medical records. the whole model of the system is divided into two parts-front end and back end. the front end design and analysis is done using epc (event-driven process chains), resource views, data flow diagram for data view. reporting was on donor selection, finance and collection of blood bag, blood collection process, component preparation, blood testing and blood distribution results: process mapping using event driven process chain generated a whole view of the processes involved. the resource view gave an organizational structure and the personnel involved. the data view using context diagram and data flow diagram gives a flow of data and amount of data involved. this framework can be used for business process reengineering for the blood banks by conducting a time study and removing non value added activities. data view helps analyze redundant data in each process. it also helps in staff training and orientation within the department. summary/conclusions: a systematic overview presented in this paper facilitates in removal of non value added processes, duplication of data, bottlenecks, reduction of cycle time and thereby improving service quality in blood banks. background: the transfusion of blood components, one of the most prevalent interventions in clinical practice is a major expenditure item in healthcare services which tend to increase in recent years. aims: it is intended to investigate the impact of transfusion associated costs to hospital costs in pediatric intensive care unit (picu) patients. methods: during a year period (january -december ) patients, females and males receiving transfusion with blood components along the stay in picu were included in the study. transfusion associated costs and total costs for healthcare services for children treated in picu was collected by using hospital information system (his). statistical analysis of data was performed by spss software (version . , spss inc., chicago, il, usa). mann-whitney u test and kruskal-wallis test was performed for comparison of independent categoric variables and numeric data; chi-square analysis was performed for comparison of two numeric variables and spearman correlation analysis was performed for associations. results: the median age of patients was . months (interquantile range-iqr ). the median length of stay was days (iqr ). in total blood components were transfused in which of red blood cell concentrates, apheresis platelet concentrates, granulocyte concentrates, fresh frozen plasmas, and cryoprecipitate and whole blood. the ratios of transfusion associated expenditures to hospital costs were categorized in intervals of percentages as < %, - %, - % and > %. most of the patients ( . %) were ranked in the lowest interval. the medians for hospital cost and transfusion associated cost were . euros (iqr = . ) and . euros (iqr = . ), respectively. a significant strong positive correlation between numbers of transfusions and hospitalization cost of picu was detected (r: . , p < . ). while it was found a significant weak positive correlation between transfusion associated cost and hospital cost (r: . , p = . ) there was also a significant weak positive correlation between the age and transfusion associated cost (p = . , r: . ). a significant difference was found between the patients with and without hematological malignancies (p < . ) for transfusion associated cost. the reason why pediatric dosages are mostly prefer is that the hospital provides healthcare for only children and splitting of the blood components was common in the hospital. but unexpectedly a significant increase on the transfusion associated costs which is related to split blood components was detected (p < . ). summary/conclusions: studies on the economics of blood transfusion have been conducted mostly in patients who require chronic or multiple transfusions. picus, specialized facilities that provide care for patients with severe life-threatening diseases are major departments often necessitate multiple transfusions. there are many variables to evaluate the impact of transfusion associated cost to hospital cost in picu patients, but the major factors are underlying conditions, admitting diagnoses and transfusion strategies. although there are unexpected data in our study demonstrated the increasing impact on transfusion associated cost originated from blood components split for pediatric usage no significant relationship was determined to explain this situation. further studies on the economics of blood transfusions have to be carried out to clarify the variables of transfusion associated costs. background: approximately . % of the transfused blood component is packed red cell (prc). over ordering of prc unit is a common practice and excessive pretransfusion testing was being wasteful of resources and have adverse consequences on cost. high crossmatch to transfusion (c/t) ratio as quality indicator of blood bank implies that crossmatches were performed unnecessarily. aims: the aims of this study were to evaluate the cost effectiveness of strategies for limiting the number of pretransfusion testing of ordering prc. methods: all prc units who ordered from dr. hasan sadikin hospital from january to december were collected in this retrospective study. number of ordering prc unit, completed pretransfusion testing of ordering prc units, and prc units that were transfused were recorded. restrictive pretransfusion testing strategies were done based on the hemoglobin level and diagnosis as transfusion indication criteria. cost effectiveness was measured by multiplying the unit cost of pretransfusion testing and number of prc unit. results: out of total , ordered prc unit, , ( . %) were subjected to pretransfusion testing and . % ( , ) of ordering prc unit which are pretransfusion testing were transfused. this means that . % ( , ) of ordering prc unit were not subjected to pretransfusion test. this showed savings of , , , rupiah. c/t ratio was . which demonstrate a good ordering pattern. however, . % ( , ) of completed pretransfusion testing of ordering prc unit were not transfused, leading to blood bank loss of , , , rupiah. summary/conclusions: strategies for limiting the number of pretransfusion testing on the good c/t ratio was still associated with saving cost effective background: blood is a precious resource for saving patient lives. the purpose of blood and blood component therapy is to provide suitable and safe blood products to achieve best clinical outcomes. nurses have an important role in ensuring safe blood transfusion. it is crucial for nurses to have sufficient knowledge about blood donation and collection, storage, component preparation, possible adverse effects of blood transfusion and necessary management and care. aims: the aim of this study was to assess the impact of an educational intervention on knowledge and awareness of nurses regarding blood transfusion services and practices. methods: the baseline study to assess the knowledge and awareness regarding blood transfusion services and practices of the nurses posted at various areas of the hospital including wards, operation theatres and critical care areas was carried out at our institute hospital which is a tertiary care teaching centre. the nurses were then sensitized and educated regarding blood transfusion services and practices during their day to day activities by referring them to the blood transfusion guidelines of the institute. subsequently, a self-developed questionnaire which was used for the baseline assessment of knowledge and awareness of the nurses was again used to reassess them. a total of questions were included in the questionnaire pertaining to: general awareness (two questions), blood donation (two questions), testing and blood component preparation related (two questions), storage of blood/blood components (two questions) and pre-transfusion checks and bed side transfusion practices (eleven questions). fifty nurses each were included for both the baseline as well as post-sensitization assessment. for different category of questions, the correct response rates were compared with those obtained in the baseline study using mann-whitney test. the entire study duration was spread over a period of three months (december, to february, . results: the overall mean percentage of 'correct' responses for questions in the baseline study was . %, whereas post sensitization it was . %. the mean percentage increase in general awareness related questions was . %, . % for storage of blood/blood components related questions, . % for pre-transfusion checks and bedside transfusion practices related questions, . % for testing and blood component preparation related questions and . % for blood donation related questions. the percentage increase in correct response was found to be statically significant for each of the five categories of questions. the overall mean percentage increase in correct response rate was also statistically significant (p < . ). summary/conclusions: this study revealed that after sensitization and educational intervention there was a significant improvement in the knowledge and awareness of nurses regarding the blood transfusion services and practices. abstract withdrawn. background: tact, introduced in the uk in to support managers, provides resource-saving, continual, 'real-time' monitoring of knowledge-based competency of staff in transfusion laboratories. tact is available online / , complementing existing practical competency schemes and external quality assessment. multiple variations on a standard pre-transfusion testing scenario are generated using constrained randomisation; logic rules for automatic assessment of sample acceptance, abo/d, antibody screen and identification (as/id), and component issue are based on bsh guidance. during , tact was offered internationally to transfusion laboratory managers to trial, and saw uptake in five countries. the core tact programme, based upon uk guidelines, is under review for programming conversion, to be customisable for the international community. aims: to assess the feasibility of tact programming conversion to meet the requirements of country-specific pre-transfusion testing guidelines, and to direct future programming in line with feedback from international users. methods: guidelines from / international users were obtained and translated where necessary. these were compared against the core assessment elements of current tact programming. international users were approached for their feedback on the current version of tact, as it compared to their local policies and practices. results: the following criteria were cross-referenced: specification of transfusion request forms, sample label acceptance criteria, reagents used for abo/d and as/id, resolution of grouping anomalies, alloantibody confirmation/exclusion, and selection criteria of blood components for transfusion-dependent patients and women of child-bearing potential. apparent differences included:-australia:--selection of red cells for patients with immune anti-d. greece:--inclusion of the name of the patient's father on the transfusion request. italy:--testing of all new patients with an anti-a,b reagent and two different monoclonal anti-d reagents. international users in the same three countries supplied feedback. this included suggestions for:-greater complexity of cases presented, provision of patient history, inclusion of follow-on tests e.g. phenotyping and cells for antibody confirmation/exclusion, broader range of reaction strength grading, and official professional cpd credits. the following differences were noted:-nomenclature used, the format and content of the request form, use of english abbreviations of patient clinical details, and the availability, provision and specification of blood components. summary/conclusions: this analysis has shown very few instances where the current tact iteration differs from the guidelines reviewed, and that it is feasible to expand the use of tact on a more international basis. the current iteration of tact has been developed to represent an abbreviated scope of pre-transfusion testing practices, which can be applied to laboratory practice outside of the uk without difficulty. further work is required to enable international users to configure tact such that the system represents all laboratory practice on an international basis. aims: these courses provide education to clinicians on patient blood management and safe transfusion in neonatal and paediatric settings in order to improve patient outcomes and increase awareness of the national patient blood management guidelines. this analysis aimed to investigate the uptake, practical use, and perceived value of the courses by learners. methods: a retrospective analysis of course completion statistics and course evaluation data. results: there have been , paediatric and neonatal courses completed from march to february with . % of learners being nurses and/or midwives. analysis of course evaluation data (n = ) showed that these courses: -provide knowledge ( . %) -improve patient safety and outcomes ( . %) -result in change to clinical practice ( . %) -are relevant to clinical practice ( . %) -are easy to use ( . %) -are readily accessible ( . %). examples that learners provided of how they can apply this learning to their clinical practice include: -"[i am now] more aware of special requirements for neonatal blood transfusion" -"[i] feel more confident especially when talking with parents" -"[i will now be] checking the patient's blood results and will speak up for unnecessary blood sampling" -"[it's good that] when there is ambiguity in clinical practice [this is] very well shown by explanation from experts in the field" -"we don't do a lot of transfusions [and this is] a reminder that transfusions are not always the first answer to the baby's clinical picture". summary/conclusions: analysis of course and user evaluation data demonstrates that these courses are being used by nurses and doctors working in the neonatal and paediatric settings and that they provide knowledge of pbm that can be applied to clinical practice, thereby contributing to improved patient care. background: blood transfusion is a high-risk clinical activity that must be mastered both theoretically and practically in order to guarantee the required result without any incident or complications. the mastery of transfusion knowledge among nurses represents a very important link in the transfusion chain. the objective of this work is to compare the theoretical and practical knowledge of transfusion among two groups of nurses divided according to their seniority. aims: this is a cross-sectional descriptive study conducted over a period of month [ st april- th april] . we selected two groups of care staff: the st group consists of students at the end of their training at the higher institute of nursing sciences. the nd is made up of nurses working in university hospitals of tunis, currently practicing blood transfusion. the evaluation's tool used was a questionnaire of simple or multiple choice questions, were related to theoretical knowledge of labile blood products and to transfusion practice. ten questions were considered "life-threatening" if their answers were false. a comparative study was made between the two groups. methods: this is a cross-sectional descriptive study conducted over a period of month [ st april- th april] . we selected two groups of care staff: the st group consists of students at the end of their training at the higher institute of nursing sciences. the nd is made up of nurses working in university hospitals of tunis, currently practicing blood transfusion. the evaluation's tool used was a questionnaire of simple or multiple choice questions, were related to theoretical knowledge of labile blood products and to transfusion practice. ten questions were considered "life-threatening" if their answers were false. a comparative study was made between the two groups. results: the participation rate in the survey was %. the nd group participants had an average seniority of years . more than half of them ( %) had seniority of less than years. only % had more than years of experience. the rate of correct answers for all items combined was . % for students versus . % for practicing nurses. the theoretical knowledge part was more mastered in the st group than that of practicing nurses ( . % vs . % of correct answers). on the other hand, the control of the transfusion act was better in nd group ( % vs . %). the overall "dangerous" response rate was % for students and . % for practicing nurses. false practical knowledge was more common in group ( . % vs. . %). summary/conclusions: the theoretical as well as the practical knowledge remains not well mastered by the care staff. our study highlighted the best theoretical mastery for young students and practical for practicing nurses. this could be explained by the freshness of knowledge in the first group and the daily practice in the second group. background: the european commission (ec) directive / /ec on blood donor selection criteria is years old. in the meantime, knowledge on risks related to blood donor selection has progressed and challenged several obligatory rules. transpose -transfusion and transplantation: protection and selection of donors, is a european commission co-funded project with participation of more than stakeholders from both not-for-profit and private organizations providing substances of human origin (soho). the project aims to provide evidence-based donor selection criteria and guiding principles for risk assessment of threats to the safety of soho. as part of this work, an inventory of current blood donor selection criteria in europe and an evaluation of the evidence behind current practice was performed by experts working on this project. aims: to identify the gap between the ec directive / /ec on whole blood donor selection criteria and a current evaluation of the clinical relevance of the criteria based on scientific literature by a panel of european experts within the transpose project. methods: in , we performed an inventory of blood donor and transfusion recipient risks in participating european countries. project members were asked to provide the existing donor selection criteria related to these risks and to carry out a risk-based evaluation for each of them. the evaluation was based on the available scientific literature and on a risk assessment template based on the abo risk-based decision-making framework, developed by transpose. all risks with divergent assessments within the panel were resolved through discussion; in all cases an expert consensus was established. subsequently we compared the results with the content of the ec directive / /ec for every risk, thereby identifying discrepancies and missing items in the directive. results: the panel identified risks considered to be significant, distributed between donors and recipients. for / ( %) of them the expert evaluation deviated from the content of the ec directive, or the ec directive provided no information about the decision making. in particular, a discrepancy was observed for / criteria concerning general health and medication, / for transfusion transmissible infections, / for high-risk behaviour and travel, and / for other diseases. summary/conclusions: our results highlight a significant gap between the whole blood donor selection criteria stated in the ec directive / /ec and the scientific evaluation performed by a panel of transpose participating experts. this gap includes both new risks not addressed in the ec directive and addressed risks that are however evaluated differently. this involves both blood donor and transfusion recipient safety, and various medical and epidemiological topics covering several aspects of the blood donation criteria. we strongly recommend a change in the european legislation, allowing a procedure to guarantee that blood donor selection criteria are updated regularly within the framework of the european institutions, to keep aligned with scientific progress, epidemiology and changes in medical practice, in order to enable an updated risk-and evidence-based framework for donor selection criteria. the risk-assessment method elaborated in the transpose project is a valuable instrument for this purpose. background: the brazilian health regulatory agency -anvisa has developed the method for assessment of potential risk in hemotherapy services (marpsh) which is based on the data collected during the inspections of blood services carried out by regulatory authorities. using marpsh any blood service can be classified in one of possible potential risk categories: high, medium-high, medium, medium-low and low risk. each category represents a different potential risk level, according to the proportion of compliance with the established regulatory requirements. marpsh has been used since , showing a trend of risk reduction on blood services evaluated all over the country. aims: this work aims to describe the utilization of marpsh as a tool for an integrated risk management model. also, it shows the main results obtained after years of data monitoring and coordination of regulatory actions and policies by anvisa, targeting quality and safety of blood products. methods: the utilization of marpsh follows a network risk management model since the inspections are carried out by decentralized organs in all states and some municipalities. the inspectors fulfill a standardized inspection guide containing the regulatory requirements, where each item is associated with a level of risk, varying from i to iii as the risk increases. at the end of the inspection, after a statistical calculation, the service is categorized. this classification gives an estimate of its quality profile, guiding the adoption of suitable measures for risk management by local authorities and services. these data are send to the states (if realized by municipalities) and to anvisa that perform consolidation in a national level. either states or anvisa use data to coordinate risk management measures in a broader spectrum. data are continuously monitored by anvisa as part of its strategical panel of indicators. anvisa follows up specially blood services in high and medium-high risk with the aim of helping or complementing local authorities' actions. additionally, anvisa periodically sends this information to the brazilian ministry of health and local governmental organs from brazilian national blood system that also support actions to improve quality in their blood services networks. results: since , when the assessment covered blood services, marpsh reached blood services in ( % of the blood services registered) what corresponded to almost % of the inspection cover in this year. over this period ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) it is possible to notice a dramatic decreasing in trend for proportion of blood services classified as high and medium-high risk, varying from % to %. summary/conclusions: marpsh generates data necessary to the categorization of blood services into five levels of potential risk. as a result, the regulatory actions are applied by local organs with the purpose of reducing or eliminating risks involved in the production and use of blood components. data have shown a significant risk reduction over years of marpsh's utilization. additionally, monitoring of this data at a national level has been permitting appropriate planning and prioritization of integrated strategies directed to risk management and strengthening of blood services in brazil. background: sub-saharan africa has the highest need of blood transfusion in the world, mainly for childbearing women and children suffering from malaria. meeting basic quality and operational requirements to provide patients with safe blood remains a challenge in these settings. aims: the aim was to identify and prioritize potential hazards for patients in blood bank practices in the democratic republic of the congo (drc). we focused on two subsets: (i) sensibilisation and selection of donors, and (ii) qualification and production of blood products, using failure mode effect analysis (fmea). methods: two risk analysis workshops were organized at the national blood transfusion centre in kinshasa, the democratic republic of the congo. in both workshops, a multidisciplinary team was invited to represent different hospitals and profiles in transfusion management in drc: quality coordinators (n = ), training coordinator (n = ), medical doctor for donor selection (n = ), hemovigilance officer (n = ), laboratory technicians performing donor sampling, blood qualification and production (n = ), biomedical scientists (n = ), microbiologist (n = ), clinical biologist (n = ), nurse (n = ). the principle of fmea was applied, which implies identification of possible hazards (failures) in a process flow, followed by scoring each hazard according to their impact, probability, detection and feasibility. in the both workshops, participants were guided by an external facilitator who guaranteed common understanding of the methodology. main focus of the risk analysis was potential harm to the transfused patient in the process of (i) sensibilisation and selection of donors, and (ii) qualification and production of blood products. all ideas were written on coloured cards and mapped on a chart according to their impact, probability, detection and feasibility score. hazards were ranked according to their final risk score by multiplying these four scores. results: in the process of sensibilisation and selection of donors, the three hazards with the highest final score for impact, probability, detection and feasibility were: (i) a paid donor is recruited after sensibilisation by family members of the patient, (ii) donor selection staff approves a non-eligible donor for blood donation because of personal/financial motivation, (iii) blood donors are not correctly informed about blood donation during sensibilisation by family members of patients. in the flow of qualification of blood products, highest scores were made for: (i) no double check for validation and sorting of qualified blood products, (ii) stock-out of reagents, (iii) no check for match between registered test result and tested blood tube. regarding production of blood products, the top three consisted of: (i) transport time between blood collection and processing is > h, (ii) storage of qualified and quarantined blood products in the same fridge (some sites only), (iii) power cuts. summary/conclusions: the risk analysis resulted in three prioritized hazards in the process of donor selection/sensibilisation and blood product qualification/production. some are very specific to the sub-saharan african setting and have been described before (power cut, family and paid donors, stock rupture,. . .). an action plan needs to be put in place to reduce their final risk score. the risk analysis needs to be continued for the remaining blood transfusion flows. background: . million of germany's population, so just under a quarter of residents, have a migration background. the majority of these has roots in regions where the population has a distribution pattern of blood group and hla-antigens that differs considerably from the predominant one in the german population. sufficient supply of these individuals with red blood cell (rbc) and platelet concentrates (tc) will continue to be a major challenge in the future, as blood donors with compatible blood group antigens are dramatically underrepresented in the local donor pools. many migrants suffer from severe hematological disorders such as b-thalassemia or sickle cell disease and will not only need compatible blood transfusions, but an allogeneic stem cell transplantation in the foreseeable future. as healthy family donors often are not available, at present suitable stem cell donors with a similar genetic background can only be found in international donor registries. aims: this project was initiated to recruit new donors with a migration background for blood donation and to increase the number of blood stem cell donors among this group. methods: serological extended blood group phenotyping was performed by automated gel card technique (fa. grifols, erytra) and included ab , rh (ccdee), kk, fy (ab), jk(ab), lu(ab), m, n, s, s. hla typing for hla-a, -b, -c, -dr, -dq, and -dp was performed by next generation sequencing. allele frequencies were analysed using genepop version . ; the rare and very rare alleles were defined according to the allele frequency database (www.allelefrequencies.net) rbc genotyping using next generation sequencing is currently being established and will include additional antigens with the most frequent distribution pattern differences between migrant and resident populations according to literature. results: so far, more than blood donors with a migration background have been recruited for a blood donation in this project. amongst this group, over blood donors from more than non-european countries enrolled as potential stem cell donors. an initial evaluation of the data revealed a very similar distribution of blood groups compared to the current blood donor population in north rhine-westphalia. of migrant donors, ten fy(a-b-) donors were identified, which corresponds to a percentage of . %. amongst hla-typed potential stem cell donors, we found ( . %) with rare and very rare alleles. summary/conclusions: blood donors with rare blood group and hla phenotypes (e.g. null types such as fy(a-b-)), are in demand for adequate medical care of people with a migration background. the technological development of blood group determination by next generation sequencing will significantly improve the supply for all blood transfusion recipients in germany. this project is funded by the european development fund - (erdf) and the european union. background: mortality due to uncontrolled haemorrhage following trauma is the most important cause of potentially preventable deaths. trauma care systems in low and middle income countries like india, are still in developing phase. also, the role of blood component therapy in improving patient outcomes has been mostly derived from combat settings. application of these protocols in an urban setup has not been well established and marked variation in practice exists. hence this study aims to identify the key components of transfusion practices to optimize the transfusion protocol in trauma settings. aims: to study the current transfusion practices in severely injured trauma patients, admitted to the red area/resuscitation bay after initial triage in ed methods: this prospective observational study was conducted over a period of year starting from june to may at the department of transfusion medicine in collaboration with emergency department at jpnatc, aiims, new delhi. the study included severely injured patients (iss ≥ ) that were admitted within h to the red area/resuscitation bay after triage. data collected included the demographics, injury, laboratory and transfusion details for these patients results: during the study period patients ( . % males) were enrolled. mean iss scores was . . mean time to hospital admission after injury was : (iqr . - : ) hours. mean time to first rbc transfusion following admission was : (iqr : - : ) hours. approximately . % ( ) patients were in shock (sbp < mm hg &/or pulse rate > /min). whereas, ( . %) patients were coagulopathic (pt ≥ . times of normal). during initial h of admission, these patients were transfused with ( . %) rbc, ( . %) ffp, ( . %) rdp and ( . %) cryoprecipitate of total blood components utilized for these patients. massive transfusion (defined as transfusion of ≥ units/ h) was given to ( . %) patients. summary/conclusions: significant quantity of blood components were required during initial resuscitation in severely injured patients. pre-hospital transfusion can significantly reduce the time to transfusion. further studies are needed to assess utility of pre hospital transfusion in severely injured patients. background: allogenic stem cell transplantation recipients are known to be the main consumers of platelet concentrates (pc). the geneva university hospital is one of the three allogeneic hematopoietic stem cell transplantation (hsct) centers in switzerland. since the blood center is also part of the hospital, data of pc consumption are easily available. as needs rose steadily since several years, with an average increase of % per year, pc supply is a serious concern for our center. aims: in this study we tried to evaluate if any pre-transplant indicator could help to forecast the number of pc needed after an allogeneic hematopoietic stem cell transplantation. methods: this observational retrospective study was conducted in geneva hospital on patients suffering from various inherited or acquired disorders of the hematopoietic system who were treated by hsct in . pc consumption was examined from january to december . the five indicators were: gender, stem cell source (bone marrow (bm) vs peripheral blood stem cell (pbsc)), donor type (hla matched ( - / ) vs haploidentical), conditioning regimen (standard vs reduced intensity), and cmv serology of the recipient. results: data for a total of patients aged from to years were analyzed; ( %) were male and ( %) female; ( %) were cmv-negative and ( %) were cmv-positive. out of a total of transplants, ( . %) were haploidentical and ( . %) hla-matched. according to the stem cell source, bm was transplanted in cases ( . %), and pbsc in cases ( . %). two patients also received a cd + stem cell boost. our analysis showed that, with a mean follow-up of days, the number of pc transfused to our patients treated by hsct ranged from to units, with an average of and a median of , illustrating a high variability. the results indicated that gender, stem cell source (bm vs pbsc), conditioning regimen (standard vs reduced intensity), and cmv serology of the recipient do not have any statistical impact on platelet consumption. however, we observed a tendency of an increased need for platelet transfusion when patients were cmv positive. our results also showed a statistically significant (p = . ) higher number of pc transfused for patients treated with a haploidentical ( ) versus hla-matched ( ) transplant. summary/conclusions: this study points out the high variability of platelet consumption after hsct, which limits the forecast of platelet production needed to support allogeneic hsct recipients. a larger cohort would be required to confirm a potentially higher platelet consumption in cmv positive patients, and to consolidate our results showing a higher pc consumption for patients treated with haploidentical transplant. abstract withdrawn. background: historically at our institution, a minimum of four red blood cell (rbc) units were crossmatched for all cardiac surgery cases regardless of surgical case-type or patient characteristics. two rbc units were packed in validated blood product coolers and brought to the operating room (or); the balance of crossmatched units remained in the blood bank. a retrospective review revealed that very few rbcs were transfused ( : % ( / ), : % ( / )). moreover, approximately products were wasted each month as a direct result of this practice. thus, we recognized an opportunity to improve inventory management in terms of personnel activities and blood component utilization. aims: the goal of this study was to reduce advance preparation of coolers in cardiac surgery cases without compromising patient care and safety. we limited our intervention to those patients who were eligible for electronic crossmatch. we maintained the aforementioned historical practice for those patients with history of and/ or those who currently demonstrated clinically significant red blood cell alloantibodies. methods: a multidisciplinary group consisting of representatives from the blood bank, cardiac surgery, cardiac nursing, cardiac anesthesia and surgery quality department was assembled in october to determine whether a modification of practice was reasonable and safe. group members evaluated site specific society of thoracic surgery (sts) cardiac surgical data between july and december to establish intraoperative red cell transfusion rates classified by type and urgency of surgery. the group's main goal was to discontinue preparation of default coolers for patients eligible for electronic crossmatch who were scheduled for all types of non-emergency cardiac surgery cases in which ≤ % of historical cases required at least one red cell transfusion. additionally, team members simulated the multiple protocols by which red blood cells could be prepared and delivered to the or and estimated the time for each scenario. results: review of sts data showed that the following cases met the criteria of ≤ %: elective primary coronary artery bypass graft (cabg), urgent primary cabg, elective mitral valve repairs, and elective aortic valve replacements. simulation showed that, in patients eligible for electronic crossmatch, preparation from receipt of order to completion of unit packing for delivery took . min using the pneumatic tube system (maximum of units per tube) and . min using delivery of a cooler using a human courier. summary/conclusions: based on the simulation results, and with consensus agreement from the multidisciplinary group, default cooler preparation for elective primary cabg, urgent primary cabg, elective mvr, and elective avr was discontinued in december . one year following implementation of the change in policy rbc units were issued to the or (a % reduction); % ( ) were transfused, compared to % in . wastage rates decreased from products a month to per month on average. summary/conclusions: the most obvious drawback of pabd is the higher cost in running the program in comparison with collection of allogeneic blood in the areas of additional patient attention and clerical input in labeling, separate storage and so on. in this audit, % of the autologous blood components were not transfused into the intended recipients and wasted; in this context, the pabd program could not be considered as a cost-effective approach in protecting blood safety. background: the national blood service zimbabwe (nbsz)'s blood supply management status (bsms) is an integral process of ensuring the availability of a safe and sufficient blood supply provision. nbsz introduced a new daily blood bank statement with improved metrics from may . the new analytics approach focuses on three interactive components of the blood bank statement; the available stock, quarantine stock (as per the desired -days stocks level), and the demand versus supply. it is imperative to have a closely monitored blood supply chain because blood has limited shelf life with uncertainties in both supply and demand. the 'blood-for-free' proclamation by the government of zimbabwe in july set more pressure on the blood demand. these metric-based analytics seek to assess if the nbsz's improved blood bank statement is a realistic model for the bsms. aims: to assess the use of the interactive metrics in monitoring the blood supply management status. methods: a prospective cross-sectional study was conducted. a total of daily blood bank statements which were submitted between may and december from each of the five branches were analyzed. the bsms which is calculated as the average of the three interactive measures of quarantine stock, available stock and demand versus supply was determined. sub-analysis of branches was done to determine individual branch performance. analysis by month was done to assess seasonal variations. findings and recommendations were shared among key stakeholders to validate the bsms methodology. results: overall the quarantine stock average was . % (sd +/- . ), the available stock was . %: (sd +/- . ) and the demand versus supply was at . % (sd +/- . ).the overall bsms was . %; (sd +/- . ) for the study period. gweru and masvingo nearly supplied all the demanded blood with . %, overall bsms of . % and . %, overall bsms of . % respectively. bulawayo supplied . % of the blood demanded with an overall bsms of . %. mutare supplied . % with a bsms of . % and harare . % and a bsms of . %. there were monthly variations but the service could supply above % of the blood demand. in the month of may the service met . % of the demand and a bsms of . %. in november and december it supplied . %, bsms of . % and . %, bsms . % respectively. august also had a below average supply of %, bsms - . %. june, october and september recorded above the average values; . %, bsms of . % and . %, with a bsms of . % respectively. summary/conclusions: the overall bsms performance was satisfactory and it was noted that branches capacitated according to demand. the new interactive analytics approach is appropriate for showing the blood bank status and assessing the performance of the branches. this new approach has optimized the decision-making process in blood supply management. the metrics are tracked using excel based model hence this approach is suitable for resource constrained settings with limited ict infrastructure . st vincent's hospital melbourne (svhm), a tertiary hospital supporting medicine, surgery and non-major trauma emergency and itu services implemented a mtp in . subsequent mtp reassessment has led to implementation of regular multi-disciplinary review of all mts to identify areas for improvement in transfusion and other aspects of support for critically bleeding patients. aims: to implement a systematic service-wide stakeholder review of mt events at svhm aiming to identify deficiencies and implement improvements in mt management. methods: a multi-disciplinary mt review team was established as a subcommittee of the hospital transfusion committee (tc) to update the organisational mtp in and subsequently continued to meet quarterly as the mt review subcommittee (mtrs) of the tc, systematically reviewing all aspects of mts at svhm. instances where or more red cell units are transfused in < h are identified from the laboratory information system and reviewed by the mtrs which includes representatives from accident and emergency, intensive care, operating suite (os) and transfusion laboratory staff; the head of the patient's treating unit is also invited to contribute. reviews include: demographics, clinical details, comorbidities, time from patient arrival to pre-transfusion specimen collection/receipt, time from blood request to release/transfusion, regularity of full blood examination (fbe)/coagulation (coag) testing, timing of blood component transfusion, total component provision/ratios, component waste, patient outcome, and communication between various clinical areas and also the laboratory. a discussion summary with actions/ recommendations is provided to the tc and some cases referred to the hospital mortality/clinical review committee. results: cases reviewed: from treating units including cardiothoracic surgery ( ) hepatobiliary/gastrointestinal/colorectal surgery ( ), vascular surgery ( ), neurosurgery ( ), orthopaedic surgery ( ), endocrine ( ) and "other" (encompassing general surgery, urology, general medicine and oncology - ). areas for monitoring/improvement identified: transfusion documentation, regularity of fbe/coag specimen submission, reducing time between patient arrival and specimen collection, reducing specimen transport time, interfacing point of care bloodgas analysers to the central pathology result management system as well as component management/waste reduction and the introduction of viscoelastometry assessment in the os. of reviewed cases involved the transfusion of emergency uncrossmatched o rhd negative red cell units. the appropriateness of the use of this precious resource is also reviewed by the mtrs. summary/conclusions: the svhm mtrs meets regularly to review mt events and formalise multidisciplinary collaboration in identifying possible improvements to support these often critically ill patients. matters highlighted include communication issues, delays in specimen delivery and blood component waste minimisation. areas for further work include minimising delay between mt events and review, and formalisation of key performance indicators for mts. background: the use of radio frequency identification (rfid) technology to manage the blood supply chain is recognized as a major enhancement to the operations of blood banks and hospital transfusion services. to facilitate optimal blood supply management, it is crucial to guarantee the integrity of rfid tags throughout the transfusion chain. since rfid tags can be affixed to blood products very early in the process, these tags undergo the same process-steps as the blood products themselves (e.g. centrifugation, label printing, shock-freezing and irradiation). aims: the goal of this study was to validate the mechanical and functional resistance of biolog-id rfid tags through different blood related processes: centrifugation, label printing, shock-freezing, intensive reading at À °c, and irradiation. biolog-id tags are passive hf ( . mhz) tags. they are compliant with is , iso - and follow the guidelines for the use of rfid technology in transfusion medicine (vox sanguinis, ). methods: biolog-id tags were evaluated using a series of rfid encoding and reading tests. before each of the processing steps, each tag was encoded with donation number, site id, product code, blood group and expiry date. the data was encoded using the isbt format. the different processing steps and conditions tested were: -centrifugation: quintuple whole blood bags, filled with ml water. centrifugation at , rpm for min. tags processed, tags per kit affixed at different positions. -shock-freezing at À °c: shock-freezer (angelantoni, sf ), units processed, reading immediately after removal from shock freezer. water, tags irradiated at gy and tags at gy results: all biolog-id tags were encoded and read with a % success rate in all series of tests. summary/conclusions: biolog-id rfid tags can be encoded and read through common processes used throughout the blood transfusion chain. their mechanical and functional integrity is not affected by centrifugation, shock-freezing, intensive reading at À °c, printing, eto sterilization and irradiation. background: the provisioning of compatible red blood cells by international cooperation is presented. the units were meant for an -year old female, with homozygous sickle cell disease (scd) and multiple complications. patients' blood group was a positive with anti-c, -e, -wr a and an antibody to a high prevalence antigen in the rh system, anti-hr b possibly combined with anti-hr b (rh ). the antibody was not reactive with rh null , -d-or hr b negative cells. the donor center put out an international request for group a or o, rh null or -d-units lacking wr a and possibly k, fy a , jk a , wr a , do a and s (the latter antigens for prophylactic matching). the patient sample had been genotyped for rhd and rhce using mlpa and sanger sequencing and the patient was found to carry rhd* /rhd* n. and rhce*cevs. / rhce*cevs. . aims: the request was sent to the american rare donor program (ardp). the ardp working with the american red cross national molecular laboratory, used the rh genotype information to identify donors carrying the same or similar rh variant alleles using the rh allele matching approach described previously (keller et al. transfusion ( s): a). methods: a recent blood sample was used to confirm anti-hr b ; no anti-hr b was detected. the patient rhd and rhce alleles were used to build punnett squares for both genes with donors carrying the same and similar alleles that would be predicted to be compatible. tier donors are those predicted to carry the same combination of rhd and rhce alleles as the patient. tier donors are those predicted to be homozygous for one of the allele combinations carried by the patient. tier donors are those predicted to carry alleles similar (but not identical) to those carried by the patient, with similar predicted phenotype. the database of donors in the ardp carrying rh variant alleles was queried against the alleles in the patient-specific punnett square. results: donors of group a or o and matched for rh alleles were identified as follows: tier , tier and tier donors. after the clinical team agreed to drop one or more of the prophylactic antigen matches, one tier unit lacking s and jk a was identified at the american red cross. while the request was being processed, the patient experienced a sickle cell crisis, red cell aplasia and recurrent aiha and her hemoglobin level dropped from to . g/dl. at that time, she was transfused the only compatible units available - of the rare -dphenotype and her hb increased to . g/dl and eventually to g/dl. the tier rh allele matched unit was shipped to amsterdam where it was frozen, and reserved for the transfusion care of this patient. summary/conclusions: this case illustrates how rh allele matched blood can be found for a highly rh alloimmunized patient, and can avoid use of the exquisitely rare -d-or rh null blood. background: blood transfusion has been a complicated and high-risky clinical procedure. any error could cause serious injuries to patients. to better assure the procedure safety. aims: we enhanced and built a blood transfusion database platform and develop inventory management strategies to better guarantee the patient transfusion safety. methods: we designed six new features of the platform ( ) assuring the patient identification with barcode techniques; ( ) designing a structured order entry; ( ) proactively reminding the physicians with patient's previous blood transfusion reaction with related precautions including the use of leukoreduction filter; ( ) automatically reminding physicians the happening of reaction and suggesting relevant test; ( ) building a complete traceability log system; and ( ) supporting data analysis. the blood transfusion safety team includes medical technologists, nurses, physicians, system analysts, and blood transporter and the whole process is electronic management. the new blood transfusion platform integrated the workflow, reduced the incidence of abnormal blood samples collected ( % after implementation, p < . ), reduced the time of call for medical technologists with blood component preparation and improved the achievement rate of emergency -min blood crossmatch ( . % after implementation, p < . ). the barcode correctly identified patients and monitored the entire transfusion process to reduce the error rate of blood component supply ( % after implementation, p < . ). summary/conclusions: after the transdisciplinary team approach with e-monitoring and a better design of clinical decision support module with barcode technology, blood transfusion database platform improve the blood supply efficiency and assure blood transfusion safety. background: in the modern world, terrorist acts are characterized by a multiplicity of combined injuries to a large number of victims. qualified medical care is urgently required for a large number of patients in one locality at the same time. it leads to increase in emergency demand for blood components, mostly red blood cells. the desire to donate blood to the victims is a natural manifestation of society's solidarity in response to tragic events. however, donor activity and patient needs do not always correlate. aims: to analyze the donor activity during the terrorist attacks. methods: a retrospective analysis of donation activity in periods of terrorist attacks in moscow ( moscow ( - . the average daily blood donations' number (dbdn) before ta compared with the number of donations in day after ta and with the dbdn during days after ta. also the number of delivered rbc units (d-rbcu) daily before ta and daily in days after were compared. results: in - , terrible ta occurred in moscow: people died and more than were injured. with the explosion in subway in / people died, were injured. the number of d-rbcus increased by % on ta-day, and by % during next days. dbdn in the st day after ta increased , times, and in the next days - , times. second explosion in subway in / resulted in died, injured. the number of d-rbcus increased by % on ta-day, and by % during days. dbdn in the st day after ta increased , times, and in the next days - , times. in (explosion on market) resulted in died, injured. d-rbcus delivery increased by % on ta-day, and by % during days. dbdn in the st day increased , times, but decreased to , times during the next week. with subway explosion in people died, were injured. the number of d-rbcus increased by % on ta-day, and by % during days. dbdn in the st day after ta increased , times, and in the next days - , times. with the explosion in airport in people died, were injured. rbcus delivery increased by % on ta-day, and by % during next days. dbdn in the st day after ta increased , times, and in the next days - , times. summary/conclusions: an increase in donor activity is observed already the next day after ta and usually lasts for days, but does not correlate with the number of victims. the rbcs' delivery from blood bank increases in all cases on the day of the ta. therefore, the guarantee for patients is the maintenance of rbcs' stock, including cryopreserved ones. it is also necessary to promptly send excess of red blood cells harvested at the peak of activity to the cryobank. background: rh system is the major blood group system besides abo system. even after proper blood grouping and cross matching there is a possibility of alloimmunisation in recipients against the rh or minor blood group antigens like kell, mnss, duffy etc. in medical colleges which cannot bear the financial burden of complete phenotyping of patient and donor, implementation of rh & kell phenotypes match blood transfusion can play a major role in preventing alloimmunisation and adverse events in multitransfusion patients aims: to evaluate the efficacy of rh & kell phenotyping as a cost effective measure instead of extended phenotyping in multitransfused patients methods: study was carried out in the department of transfusion medicine, one of the biggest blood bank of the country with annual collection of , blood units. patients of thalassemia, aplastic anemia and leukemia were taken who required multiple transfusions. complete phenotyping was done initially of all the patients before transfusion. patients were taken as control and the other were taken as cases. blood units of healthy donors were chosen ( were males and were females). in all the donor units, identification of rh & kell phenotyping was done by the antigen antibody agglutination test by the erythrocyte magnetize technology on fully automated immunohaematology analyzer qwalys. these blood units were transfused to patients who had been selected as cases. in the control group, patients were transfused blood units which were not phenotyped for rh & kell but gel crossmatching was done. follow-up was done on these patients for transfusion reactions and at the end of six months they were evaluated for any alloimmunisation. results: at the end of months, no reactions were reported in cases receiving rh & kell phenotype blood and no alloimmunisation was seen on repeat phenotyping. the control group on the other hand reported reactions in cases ( . %) and phenotype at the end of three months showed alloimmunisation with 'e' antibody. the phenotypic frequencies of rh & kell blood groups in the population were comparable with other published studies. amongst the rh antigens (e) was the most common ( . %) followed by d ( . %), c ( . %), c ( . %) and e ( . %). thus 'e' was the most common and e was the least common of all the rh types. background: the prevalence of a particular blood group has an uneven distribution in different geographic areas and is largely determined by the national composition of the population. moscow is one of the largest city of europe with population of . million. the understanding of prevalence of red blood cells antigens (rbc-ag) among the population has great importance for blood banking planning. aims: to determine frequency and distribution patterns of transfusion-significant rbc-ag among donors in the moscow region. methods: the results of immunohematological studies on ab , rhesus and kell systems were analyzed retrospectively in blood donors for years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) in moscow. data collection and processing was carried out using the regional information system for transfusiology. rbc-ag detection (ab , rh, kell) systems was performed using microplate method (automatic immunohematological analyzer "galileo neo" (immucor, inc., usa)) and "ih- " (bio-rad laboratories, usa) with diagnostic cards. results: the most frequent blood group is a (ii) . %, (i) blood group . %, b (iii) . %, ab (iv) . % (n = ). rh(d+) was established as positive in the presence of antigen d and as rh(d-) negative in its absence. donors with weak variants of antigen d (du) were determined as rh (d+) positive. the ratio of rh (d+) and rh (d-) was . % and . %, respectively. donor's phenotype detection was routinely conducted from the year, therefore the number of donors was . the most common phenotype among donors ccdee ( . %), the second in frequency ccdee ( . %), the third in frequency rhesus negative phenotype ccddee ( . %) in the studied population. the ccdee and ccdee phenotypes were . % and . %, respectively. the most rare are ccdee ( . %), ccdee ( . %), ccddee ( . %). other options: ccddee, ccdee, ccdee, ccddee, ccddee, ccdee, ccddee were detected in single cases and amounted to a total of . % (n = ). cw antigen was tested in donors and was detected in . %. cw is most commonly found in donors with ccddee phenotypes ( . %), ccdee ( . %) and ccdee ( . %), with other variants of the data phenotype, the antigen was detected in . % of the examined (n = ). antigen k was detected in . % of donors, in . % of this antigen is absent (n = ). summary/conclusions: the study of transfusion-relevant antigens distribution in population is necessary for building of effective and flexible model for blood service managing. a differentiated approach in choosing a strategy to form a long-term bank for storing blood components, taking into account the frequency of various antigen variants, contributes to improving the quality, accessibility and safety of medical care. of dislocated division of our blood establishment in orthopaedic hospital valdoltra (obv) in the number of outdated units at the hospital side dropped considerably. results: since when the issued number of red blood cell units (rbc) was the amount of issued units rose to in and then dropped more or less steadily to in . in this period the hospitals' programmes rose for % in all areas. number of donated units declined from in to in . after reorganization in the number of outdated units fell from % of stocked units to . %. after setting a dislocated unit of ctdiz on obv location the number of discarded rbc fell from to in . for transfusion specialist who is constantly in contact with the clinician in the hospital the most important day routine is when the stock availability is displayed. it happens times a day; at a.m. when the previews' day collection is released and another three times a day when the updates occur. the central base is led in ljubljana (the capital) and all centres are able to control and order the stock for the blood banking. blood wastage remained low and the traceability of the blood usage in south-western region remains high ( %). though it is not supported by an informational system the traceability form the blood bank to the patient is done on paper. this issue demands a big effort by the staff in blood bank and in hospitals. summary/conclusions: reorganization enabled better stock utilization and traceability of issued units. sometimes it is impossible to predict the peak demand of rbc especially during the summer season when the population of the area doubles and car accidents as well. transfusion specialist's effort in assuring the optimal blood stock represents the crucial daily routine. blood bank, grande international hospital, kathmandu, nepal background: voluntary non-remunerated blood donor consists of % blood donor's population in nepal. therefore demographic about the distribution of blood donors according to the age group is important to achieve % voluntary nonremunerated blood donors in nepal. aims: to explore the demographic distribution of the blood donor in different age group in the kathmandu nepal. methods: this is retrospective study conducted at nepal red cross society central blood transfusion service. data from january to january were collected from donor management software. the data includes socio demographic data. data has been process with spss version - results: during years study period, total of , blood donation happened from both mobile blood collection and in-house blood collection. out of , collection, ( . %) are from - age group; ( . %) are from - age group ( . %) are from - age group; ( . %) are from group - age group; ( . %) are from age group - and ( . %) from age group above respectively. summary/conclusions: the distribution of abo blood group varies regionally and from one population to another. in kathmandu, nepal - years age group is the most common age group encountered donating blood. the data generated in the present study and several other studies of different geographical region of india will be useful to health planners and future health challenges in the region. background: the information system on hemovigilance sihevi-ins©, coordinated by the national health institute was available in to all blood banks in the country. this software allows to centralize and record the identification data of a donor, its infectious and immunohematological tests, as well as the fractionation and final destination of each blood component obtained from a donor. aims: to describe the abo and rhd typing discrepancies in blood donors found in the blood group variables registered by each blood bank to sihevi-ins©. methods: retrospective analysis of the information registered by of the blood banks authorized nationwide between january and december . results: sihevi-ins© received information of , accepted donors, % of them with more than one donation in the same blood bank in a period of months. a total of abo or rhd discrepancies were identified in people, who made donations in blood banks (estimated risk: one discrepancy per , accepted donors). five of the blood banks implicated in these discrepancies are hospital-based (annual average collection of , ae , units, representing . % of the national collect). the remaining blood banks are distributors (average collection: , ae , units per year, representing % of the national collect). % of blood group typing discrepancies (n = ) were related to the abo group. the most common discrepancy was between a typing group and ab typing group ( %) . in % of the cases, the same blood bank initially registered in the same donor, an o blood type donation and later an a blood type (n = ) or b type (n = ). rhd typing discrepancies account for % (n = ) of the total. additionally, in three donors, a simultaneous discrepancy between abo and rhd typing was detected in the same blood bank. the results could be due to: a) failure in the warning mechanism before the release of the blood component; b) errors in typing the information of the donor registered in the system or c) failures in the identification of the donors at the time of selection. the above shows risk in the process of control of blood components release, which can impact patient safety unless abo and rhd typing blood groups are systematically verified before transfusion. summary/conclusions: despite blood banks have a verification and validation process through software to release blood components, flaws were detected. although sihevi-ins© is not a software to validate the information before the release of blood components, it was through this program that abo and rhd typing discrepancies were identified in donors who attended the same blood bank multiple times. this finding implies increasing the controls that should be used in each blood bank, to avoid lose traceability of the processes and to put at risk the life of the recipients. blood donor testing department, blood transfusion institute of nis, nis, serbia background: the ability to automate blood grouping and antibody detection procedures is a requirement for blood donor testing laboratories. mistakes in the sample identification and testing procedures could be prevented by testing on automated immuno-hematology systems. irregular antibody screening and abo/rhd grouping of blood donors are tests performed routinely in blood transfusion institute of nis. neo iris (immucor, usa) is a fully automated instrument for the abo and rh d grouping using microplate hemagglutination technique and antibody screening and identification using solid phase red cell adherence (sprca). aims: evaluation of the automated neo iris system for abo and d grouping and irregular antibody screening of blood donors in blood transfusion institute of nis. methods: during the evaluation period a total of edta-anticoagulated samples for abo and d forward and reverse grouping using microplate anti-s, anti-s, anti-jka and anti-k. in one case ih- failed to identify anti-c antibody in very low titer in sample with anti c+d antibody presence. in two samples ( . %) false-positive result were observed both on ih- system and neo iris and in two cases ( . %)only on neo iris due to nonspecific reasons. summary/conclusions: abo/rhd grouping results obtained on neo iris system, using microplate method, have a good correlation with results on ih- system as our routine column agglutination method. for antibody screening and identification neo iris showed high sensitivity for detection of clinically significant antibodies which is important step for increasing blood transfusion safety. background: continuing improvement of laboratory quality to provide accuracy test results for precise diagnosis and treatment is the mission of advanced laboratory. immunogenetic testing for histocompatibility including human leukocyte antigen (hla) typing, hla antibody detection and cytotoxicity test is critical for diagnosis and evaluation of transplantation and prognosis monitoring. in order to improve the quality of experiment competency, an external quality assurance schemes with review and education per year program was established and performed during the period from to in taiwan. aims: the proficiency testing (pt) held semiannually from to were reviewed to investigate the outcome of competency improvement of laboratories participated in the program. methods: the test items in the exercises were classified into groups, hla genotyping (including pharmacogenetics hla typing), cytotoxicity test, hla and platelet antibody. the methods of hla genotyping include ssp (sequence specific primer), sso (sequence specific oligonucleotide), sbt (sequence based typing) and either ssp+sso or ssp+sbt were used, the methods of hla antibody including elisa, flow cytometry and luminex were used and the methods of platelet antibody including sprca and elisa were used. there are four shipments of exercise materials in two years and each shipment include two positive and one negative samples for antibody detection, two each of whole blood and serum for cytotoxicity of t and b cell and three whole blood for hla genotyping. aims: this study aims to survey transfusion related laboratory tests for the quality improvement of hospital's blood bank management. methods: we analyzed survey results of kinds of routine work categories of blood banks that were registered on korean association of external quality assessment service. blood bank worker voluntarily replied this electronic survey. the categories were as follows: . characteristics of institution . the equipment of blood bank . the kinds of tube in blood bank . the present kinds of blood bank tests . abo and rh type tests . the cross-match tests . the irregular antibody tests . hemovigilance system . other blood bank tests . massive transfusion protocol . quality control issues we analyzed and compared each category data according to considering characteristics of hospitals. results: there were consensus and some differences of current blood bank tests. we presents the result of a pilot survey. especially the cross-match tests were divided by saline phase method added with irregular antibody tests or completion of rd step anti-human globulin phase according to institutional environment. automated typing machines or automated irregular antibody test devices were more increased in large-scale hospitals than small-scale hospitals. different kinds of tubes were used such as edta tube for abo and rh typing, plain tube for cross-match test. the retention segments of rbc were reserved for minimum days. most blood bank were registered and regularly listed up transfusion events to korean hemovigilance system for safety transfusion. also, a lot of institution have none or underdeveloped massive transfusion protocol. more specific survey results will be analyzed in further poster presentation. summary/conclusions: this survey will show the current status of transfusion related blood bank test. this institutional blood bank comparison will be helpful to assess the currency of individual blood bank environments. abstract withdrawn. background: we know that quality management is a continuous process, involving implementation, maintenance and improvement. aims: our purpose is to show our experience in implementing the quality management system in the whole institution and our first steps in achieving the jacie accreditation in the stem cell collection facility in order to provide our patients and donors the best possible care. methods: the institute for transfusion medicine of the republic of macedonia (itm) is the main institution in charge of blood transfusion service (bts) in the whole country, which is the national unified system. the stem cell collection facility is a part of the itm. this facility is operational since year with collections of stem cells ( in patients and collections in sibling donors) till now. we are obtaining the implementation and maintenance of qms through the establishing of the iso standardization for the whole institution (itm), as well as of implementing jacie standards in the stem cell collection facility. the two of our colleagues became the jacie inspectors and the standard operating procedures (sops) were developed, followed by regular meetings, trainings and self-evaluation of the personnel. we asked for the orientation visit from the independent jacie inspector in order to come one step closer to the jacie accreditation and to improve our overall qms. results: the institute for transfusion medicine of rm was a part of the ipa project "strengthening the blood supply system". this project aimed to ultimately bring the blood transfusion service to european union standards allowing the exchange of blood components and all other types of collaboration with other european union countries in future. the project put the basis for unification of blood transfusion standards and operating procedures in the whole country as well as set up essential education of blood transfusion personnel. although a lot of strengths were found during the orientation visit from jacie inspector, there are still a lot of areas for improvement. our strengths are motivated team and supportive institutional leadership including macedonian ministry of health. areas for improvement are: labeling of cellular therapy products and lack of laboratory for quality control. there is a national regulatory framework in place and who and world bank initiatives in macedonia which support quality in health care and accreditation. summary/conclusions: our institution has in plan to implement isbt standards for labeling of cellular therapy products and to establish a laboratory for quality control of cellular therapy, as well as to meet all the requirements to become jacie accredited facility. working by standards, following the rules and regular self-evaluations will help us to maintain the strong quality management system. every institution will benefit from a quality management system that brings you into line with international standards. ensuring the quality of our services and products is essential to keep safe and strong blood transfusion service. background: implementation of robust quality assurance program is key to high performing blood establishments. quality control and quality assurance systems together constitute the key quality systems and are parts of quality management. effective and efficient quality control policies not only provide guidance that help to increase the reliability of results but also maintains the laboratory's consistence performance overtime. aims: therefore, we established a set of qc limit using historical data which can timely identify unexpected variation in the testing systems and trigger a review of test processes in blood screening laboratories as part of quality assurance system. methods: last two consecutive years (jan, to dec, ) qc data from archi-tect i sr (abbott laboratories, chicago) was extracted using abbottlink for philippines red cross tower national blood center total of data points ( data points in & data points in ) were obtained for different qc levels for four serological blood screening assays (hiv combo, hbsag, anti-hcv, syphilis). the data was sorted for each assay/lot and qc level combination by year. qc limits were calculated using simple mean, standard deviation (sd) and coefficient of variation (cv%) and were validated and compared with manufacturer's recommendation. results: all the six positive quality control levels cv% ( . - . ) were within manufacturer's precision recommendation (within lab precision hbsag ≤ %, anti-hcv ≤ %, syphilis ≤ %, hiv ≤ %) in . five out of six positive quality control levels cv% ( . - . ) showed within manufacturer's precision recommendation (within lab precision hbsag ≤ %, anti-hcv ≤ %, syphilis ≤ %, hiv ≤ %) in except syphilis tp positive control ( . %). all four negative quality control levels showed the sd values within . - . in and . - . in respectively. summary/conclusions: excellent qc performance was observed in philippines red cross tower national blood center blood screening laboratory based on historical data and evidence-based laboratory qc limit for blood screening assays were established using historical data which takes into account total variation expected in a test system and offers a more robust and meaningful mechanism for setting control limits, for the first time. background: quality indicators (qi) in transfusion medicine (tm) are 'critically important aspects of transfusion medicine practice that are measured and utilized to gain insight for continuous quality improvement, into the degree to which the tm is capable of providing quality tm care, products or services for the aspect of practice measured following comparison of the measurement against acceptable local or international reference thresholds, benchmarks, standards, or practice guidelines'. the critical control point (ccp) selected for this study is 'administration techniques and monitoring of key elements'. this has been selected since the clinical fraternity plays a larger role in ensuring quality services in administration of blood components. there was a need to follow up compliance to standard protocol for bedside transfusion practices hence was decided to study the same with four selected quality indicators and introduce corrective measures if necessary. aims: . to assess the existing transfusion practices in the institute with specific quality indicators . to introduce corrective reforms to improve the existing practice . to assess the transfusion practices after interventions using the same quality indicators methods: to assess the existing transfusion practices in our centre, transfusions were prospectively followed up with a structured checklist. the quality indicators used were (i) verification of blood components prior to transfusion (ii)initiation of transfusion within min of release from the blood bank (iii) close observation of transfusions for the first min (iv)completion of transfusion within the right time frame for each component. as a corrective measure, a transfusion monitoring format was designed which was distributed in every ward and the nursing officers were informed to monitor and document transfusions using that. in addition, the blood bank staff was made to call up the wards and ensure that the transfusions of every component had been initiated within min of issue. transfusion practices were once again monitored by following up transfusions using the same quality indicators. results: there was significant difference in all the four variables between the two phases. . % transfusions were verified in phase i while . % were verified in phase ii (p < . ). . % transfusions were started within half an hour of issue while in the second phase, it rose to . % (p < . ). . % transfusions were observed in the first min in phase i and . % were observed in the second phase (p < . ). in phase i, . % transfusions were completed within right time while the same in phase ii was . % (p < . ). summary/conclusions: we recommend the following as quality indicators for bedside transfusion practices: background: antibody titration consists in performing antibody detection with selected red cells of different sample dilutions. the titer is reported as the reciprocal of the highest dilution that induces macroscopic agglutination. the usual applications of titration are prenatal studies and complex antibodies identification. some publications have demonstrated that more variation in antibody titer and titration score are noted upon repeat testing of the same sample when testing was performed in tubes as compared to repeat testing in gel. aims: to evaluate the efficacy of automated antibody titration versus manual method by using gel microcolumn technology. methods: edta-anticoagulated whole blood donors' and plasma frozen samples containing a known irregular (rh, kidd, duffy, mns, etc.) and regular (a & b) antibodies were selected. the titers of samples were determined in parallel by using grifols analyzers (erytra and erytra eflexis) and compared versus grifols gel manual method by using grifols gel microcolumn technology and grifols red blood cell reagents. sixty of these also processed in parallel in erytra and erytra eflexis analyzers for comparison. for the precision study, of these samples were tested in the automated systems for times ( datapoints for each analyzer) on different testing days. the hands-on (manual intervention) average time required to complete a titration was measured ( expert technicians) in different sample workload ( and samples testing). these results were compared with the same number of independent titrations performed in grifols analyzers. for the walk-away time, different sample workload ( and samples testing) were assessed in manual method ( expert technicians) and compared to timings obtained when reproduced in grifols analyzers. results provided by analyzers were reviewed and compared to manual method. results: titer obtained by erytra or erytra eflexis was equivalent to the titer obtained manually (differences ≤ titer: % ≤ . titer). the results proved that both instruments were equivalent in performing titration (differences ≤ titer; % ≤ . titer). the precision results showed no difference between titers obtained through the % of the runs performed with the grifols analyzers (differences ≤ titer: % ≤ . titer). the manual hands-on in automated system was reduced in a % compared to manual method for sample. when the number of samples was increased ( samples), the difference in hands-on in was even more reduced ( %). in addition, the walk-away was % higher in automated system compared to manual method. furthermore, when the number of samples was increased ( samples), the walk-away difference was increased even more ( %). finally, automated system software demonstrated to increase the standardization of the test as all samples, results and reagents traceability were automatically managed. summary/conclusions: grifols gel system including erytra and erytra eflexis analyzers provided a scalable and efficient solution to perform standardized titrations in the immunohematology lab. the study proved that using grifols gel system, titrations can be run in an automated reliable way (less than one-fold differences versus manual gel), thus reducing at least % the hands-on, increasing at least % the walk-away, rising the standardization and automating all testing traceability. , and fourth case of use (results) scenarios, tasks were considered "very easy" by %> % of users and "easy" and by - % of users; %> % of the users considered "sufficient" the design to ease the interaction; and %> % of users never founding any situation of not knowing how to proceed. for the fifth case of use (user roles), % of users considered tasks "very easy" or "easy"; % of users considered "sufficient" the design to ease the interaction; and % of users never found any situation of not knowing how to proceed. for the sixth case of use (maintenance plan), % of users considered tasks considered "very easy" or "easy"; % of users never found any situation of not knowing how to proceed; and % of users considered the maintenance plan similar or better than other instruments. reliability analysis ( background: quality control procedures in blood group serology for reagents, techniques, personnel working and automated equipment are essential for the accuracy of the laboratory results. the observation of high number of uninterpreted results during blood donor grouping was a motive for investigation and possible targeting the problem. aims: to identify blood group interpretation problems by analyzing the testing results obtained with the commercial quality control samples routinely used during blood grouping. methods: a microplate (mp) system for performing abo and rhd, as well as rh phenotype and kell blood group determination with two automated analyzers techno ( and ) and correspondent two mp-readers lyra ( and ) using maestro software from diamed is currently in use for blood donor typing. three types of mp are being used such as: a, b, ab, dvi-, dvi+, ctl/a , b profile for first time donors, then a, b, d ctl for repeat donors and finally, the c, c, e, e, k, ctl profile. the accuracy and safety of the blood grouping results is ensured by using the diamed q.c. system which consists of + tubes of whole blood and tubes containing serum with known specific antibodies. we analyzed and compared the interpretation of the q.c. whole blood samples' results from both of the analyzers after a new optic camera was installed on the techno /lyra system. ward to ward. methods: a prospective observational pilot study was done for around prbc unit issues which were followed in real time for understanding the tat within blood bank & from ward to ward. as per the definitions, the areas where the times are documented perfectly are understood and considered for calculations. based on the conclusions of pilot study a monitoring form has been designed and utilised to monitor the tat within bb & wtw. the data is analysed monthly and an avg tat for bb & wtw is calculated. the common causes of delay in providing the blood components were analysed and strengthened to both reduce & control the tat. results: in pilot study, total wtw tat averaged to min, with highest time taken min, where there were additional processings like leukodepletion, irradiation, saline washing of red cells and holding the transfusion. lowest wtw tat was found to be min where there was a prior information for crossmatch. after the surveillance form has been started, the average time taken for wtw tat came down to min, maximum being min (jan ), the areas where delay happened were identified as internal courier delays, technician delays, billing & other logistics delay. the concerned staff are put on regular training to maintain the tat. summary/conclusions: although ethically all the staff work for providing better care for patients, there will be few areas that delay the life supporting blood transfusion. monitoring using tat surveillance forms help in avoiding the delays and hence provide better & timely transfusion support. blood donation -blood donor recruitment p- hematological and physiological characteristics of regular blood donors with beta-thalassemia traits background: according to recent evidence, the physiological variability observed in the hematological characteristics of regular blood donors (linked -in certain caseswith genetic factors or the donor's lifestyle) may affect red blood cell (rbc) storage lesion. beta-thalassemia heterozygous (b-thal-het) blood donors represent a group of particular interest because of a) the high frequency of thalassemia mutations in specific geographical areas b) the physiology of the b-thal-het rbcs, which predisposes towards more effective management of storage-associated stress. aims: the goal of the present study was the comparative examination of the hematological and rbc physiological features of regular blood donors with or without beta-thalassemia traits before blood processing for transfusion purposes. methods: healthy blood donors of greek origin ( - years old), who met the blood donation criteria were recruited in this study. plasma/serum (uric acid, electrolytes, extracellular hemoglobin, antioxidant capacity), cellular (rbc indices) and biological parameters (corpuscular fragility, proteasomal activity etc) were measured. the results were statistically analyzed and topologically represented in biological networks for both donor groups (+/-b-thal-het). significance was accepted at p < . . results: b-thal-het represented % of the donor cohort. no differences in lifestyle (smoking, alcohol consumption, physical exercise) were observed between the two groups. nevertheless, regardless of sex and sex-dependent parameters (e.g. hct, hb concentration), b-thal-het demonstrated: a) reduced hct, mcv and mch ( % p = . , % p = . and % p = . , respectively) and b) increased rbc count ( %, p = . ) compared to the average donors. moreover, mpv platelet index was found slightly elevated (p = . ) and serum total protein concentration slightly reduced (p = . ) in the same group. a trend for higher plasma antioxidant capacity (p = . ) was evident in the group of b-thal-het, in addition to statistically significant lower levels of osmotic fragility (by %, p = . ) and hemolysis (by %, p = . ) compared to controls. finally, analysis of the three proteasome-associated enzymatic activities (n = per group) in the rbc cytosol and the membrane, revealed similar levels in the two groups (p > . ). the b-thalhet and control biological networks showed insignificant variations in respect to the amount of connections and their hub profiles. however, differences were observed regarding the number or type of connections, or even their topology in the network, in the cluster of lipids (triglycerides, ldl etc), nitric oxide, clusterin, carbonylated plasma proteins and rbc osmotic fragility (correlated with the concentration of electrolytes selectively in b-thal-het donors) between the two groups. summary/conclusions: b-thal-het who meet the criteria for blood donation are a non-negligible sub-group of the total donor population in greece. they exhibit several similarities to the general cohort, but differ in fine characteristics of rbc physiology, including resistance to hemolysis and extracellular antioxidant capacity. the differential network profile of hematological and redox parameters may be important in respect to the subsequent blood processing and storage of b-thal-het erythrocytes for transfusion purposes. background: blood service in poland is based on voluntary and non-remunerated donations. regional blood donor centre in poznan as well as other regional centres (total of ) are the only entities authorized to collect, process, store and distribute blood and its components to hospitals in the region of their activity but they are also responsible to provide sufficient amounts of blood and its components. regional blood donor centre in poznan is one of the largest blood centers in poland with the total number of donations exceeding , per year. in the recent years we have observed a growing popularity of tattoos among various age groups as well as among people registering to donate blood (first time and repeat donors) hence, it is critical to introduce suitable measures to ensure the safety of blood and its components. aims: the aim was to analyse the correlation between the increasing number of donors deferred from donating blood due to having tattoos made and the number of recorded confirmed hcv infections and the effect it may have on the safety of blood and its components. methods: the analysis was made using the data for the years - obtained from the computer system 'blood bank' which is in operation in regional blood centre in poznan, poland. we have analysed the total number of deferrals of donors due to recently acquired tattoo and the total number of recorded confirmed hepatitis c infections. we must note that the category of temporary deferrals due to tattoos is a broad one: it includes so called regular 'artistic' tattoos, permanent make-up procedures as well as medical tattoos. results: we have recorded a significant increase in number of deferrals due to tattoos from in to in (+ %). in the group of male donors this trend remained rather stable with a slight decrease: from in to in (À . %). in the group of female donors the growth was more prominent: from in to in (+ %). in terms of the recorded confirmed hcv infections a downward trend can be observed: from in to in (À . %). in the group of male donors from in to in (À %), in the group of female donors from in to in (À %). summary/conclusions: as we can conclude from the analysis the applied policy of temporary deferrals of donors with recently acquired tattoos (in the last months) proves to be a reliable method of increasing the safety of blood and its components. nevertheless, the current conduct of the qualification of the donors which requires a month deferral following the new tattoo must be complemented by various and numerous educational activities regarding the means of hcv transmission (and other bloodborne viruses such as hbv, hiv) and ways of protection from possible infections. special emphasis must be put on the group of female donors as the growth of deferrals was more prominent among them. at the same time it is vital to ensure for constant availability for all donors of well designed, concise educational materials (hard copies on the premises, articles, infographics, downloadables etc. on the website). background: a temporary deferral has a negative impact on donor retention, with many donors failing to return at the end of their deferral period. anecdotal evidence collected by the australian red cross blood service suggested that many donors do not know when they are eligible to return to donate, suggesting that a reminder message may be effective at promoting donor return once the deferral has ended. aims: the aim of this study is to evaluate the effectiveness of a reminder message on the return rates of deferred donors at the end of their deferral period. this reminder message notified donors that their deferral period was ending and encouraged them to make an appointment to donate. this study also aimed to determine the most effective time to send the message, message content, and mode of communication (sms vs email) in optimising donor retention post deferral. methods: three separate randomised controlled trials were conducted to answer these questions. data on donors' attempted return behaviour and subsequent deferrals, appointments and donations made one month after the deferral end date were collected and analysed. results: overall, . % of donors who received a reminder message attempted to return compared to . % of donors in the control group (p < . ). looking at each time point, donors who received the message week before their deferral ended were % more likely to attempt to return compared to the control group (p < . ). the week prior reminder message was particularly effective with males, with . % attempting to return to donate, compared with . % of females (p < . ). there were no significant differences in the return rates of donors who received the recipient versus non-recipient focused message, or donors who received the message via email or sms. summary/conclusions: a reminder message sent to deferred donors at the end of their deferral period is a simple, cost-effective way to promote donor retention, providing clear information regarding the date on which the donors can return to donate as well as a prompt to make an appointment background: our challenge is to provide % voluntary donation for safe blood, thus taking into account the current history of family donation, promotion of blood donation, level of awareness and voluntary donations from various institutions, the opinion of interviewees will give us a clearer idea of what we want to achieve and what needs to be improved in the future. aims: . provide % voluntary donation for safe blood. . establishing a special department within the national blood transfusion center responsible for marketing and promotion of voluntary blood donation. methods: this study was conducted as a combination of qualitative and quantitative methods. the study was a combination and identification of existing data, direct interviews with persons of different age groups, preparation and dissemination of questionnaires and analytical processing of the collected information. the study questionnaire with questions in total was divided into sections out of which questions on blood practices were answered by all interviewees. people answered questions on the blood transfusion service. questions on blood knowledge were answered by people. questions on the knowledge of the blood transfusion were answered by people, questions on blood donation were answered by people and questions on the communication channels were answered by people. results: out of interviewees, % have never donated and did not intend to donate, due to the fact that most of them were afraid of needles and infections, while the smallest part didn't donate blood because it was not allowed by the religion, % did not donate, but expressed the readiness to donate in the future, % have donated voluntarily only once, % were family donors, % regular volunteer donors, and % have donated voluntarily several times and did not want to donate anymore. from those who have donated, % have donated for one of their relatives, % have donated for thalassemic children, % have donated to benefit free check-up and % have donated because it was valuable for their health. the question as to whether they would voluntarily donate again, % have answered yes, % no and % were still not sure. this means that donation of those who have donated once did not leave a positive impression, did not increase the desire to repeat the donation once again, rather it has restrained or made it unsafe for them to repeat donation. among the causes mentioned by the interviewees were bad conditions in the donation facilities, staff behavior, inadequate treatment, they did not feel good after donation and had hematoma at the venipuncture. summary/conclusions: based on the results obtained from the study, the national blood transfusion center needs the establishment of a genuine promotion department where there is a need for a transfusion doctor who should be an active part of it. the national blood transfusion center should build up and implement a rigorous retention policy for voluntary blood donors, as the study found out that around % of donors who have donated once would like to donate again. their attraction through a donor retention policy will surely lead to self-sufficiency with safe blood. the safe blood is a public good and for this reason it is the duty of all state instances, the media and non-governmental organizations to give their support in the promotion of voluntary blood donation. background: smoking, unhealthy diet, sedentary behavior and inability to maintain adequate exercise have significant consequences for several chronic disorders, including obesity. a balanced and equilibrate nutrition may prevent the negative consequences associated to the status of obesity. in italy, overweight and obesity is increasing with adults of overweight and of obese in with a higher frequency in the south. blood centers can play a public health role in obesity surveillance and interventions. aims: since the quality of life, self-reported by the patient, related to health and adequate quali-quantitative nutrition, are becoming necessary and relevant in the field of nutrition, we conducted a demographic study to evaluate the health status of the blood donors by monitoring the nutritional habits and lifestyle. methods: a descriptive cross-sectional face-to-face questionnaire was developed. it included a item dietary assessment, reporting semi-quantitative food frequency, dietary behavior and questions on self-rated health status. normal weight was established with bmi < kg/m , overweight with a bmi ≥ and < kg/m , and obesity with bmi ≥ kg/m . obesity prevalence was standardized by sex. donors were repeat blood donors, who had made at least donations in the last years, and were eligible to donate. results: of the blood donors enrolled between july and january , were regular repeat donors, did not wish or chose not to respond at survey for several reasons (i.e. lack of time or privacy) and accepted, of which were deferred from blood donation and were excluded from the analysis. among the included participants . % (n = ) were male, age ranged from - years with a mean age of . ae . sd and . % (n = ) were female age ranged from - years with a mean age of . ae . sd. data showed that donors followed mainly a mediterranean diet and had more awareness to lifestyle, women more than men, in comparison with general population. the prevalence of overweight was found . % in men and . % in women. our survey showed that . % of the participants evaluated their health as "good", without gender difference (men, . % vs women, . %). besides, . % reported their health as "very good". summary/conclusions: overweight and obesity are common among regular blood donors and it is more frequent in men than women. our preliminary data showed that women have a better knowledge of the nutritional properties of food and consequently adopt a more balanced and proper diet. furthermore, it is clear that they are aware about the relationship between lifestyle and health putting into practice their information. unfortunately, the survey structure, of observational nature, does not make it possible to establish whether women are more alert to health to participate more in donation programs or if, on the contrary, the status of regular donor could help the improvement of knowledge and healthy lifestyle. background: donor recruitment pose an ongoing challenge to blood banks worldwide. one approach to improve the effectiveness of donor recruitment is to target influencing factors. a yearly league is conducted at the sultan qaboos university (squ) to encourage university students and faculty to donate blood. during this, the colleges are evaluated based on different measures including the number of donors recruited from each college and the efforts made by the students in increasing the awareness of blood donation in the colleges and in the society via different means including the utilization of the social media. the whole competition is organized and ran by an independent group of students. aims: this study aims at studying the impact of the yearly squ college competition on the perception of blood donation among squ students. methods: a comprehensive anonymous voluntary survey was developed and used to assess perception of students aged - attending squ and other universities (non-squ) over a two years' period. analysis was performed using ibm spss statistics . . categorized variables were presented in numbers with percentages and associations between the groups were analyzed using chi-square test. a p-value of < . was considered statistically significant. results: a total of students were surveyed ( squ, non-squ). there was no statistical difference between squ and non-squ students with regard to past history of blood donation and the number of donations made. when comparing between both cohorts, % of the squ and % of non-squ students reported the university as the main source for information (p < . ), while % of squ and % of non-squ students reported that the social media was the main source respectively (p = . ). there was no statistical difference between male and female donors on their perception of level of self-knowledge on blood donation (p = . ). about % of the youth agreed that blood donation is one of the duties toward the community. squ students reported higher rates of respond to specific requests for blood donation ( . % vs . %, p < . ). squ students reported greater influence of peers ( % vs . %, p < . ), personal knowledge ( % vs . %, p = . ) and personal experience ( . % vs %, p = . ) when compared to non-squ students. they also reported more feeling of commitment to the society ( . % vs %, p < . ). squ students reported lower influence of parents ( % vs %, p = . ), lower rates of fear from needles ( % vs %, p < . ) and lower rates of fear from blood ( % vs %, p < . ). there was no difference between male and female genders in any of the discouraging factors. summary/conclusions: these results highlighted the positive impact and important rule of the youth in the promoting blood donations among themselves through this yearly college competition; in recruiting blood donors and in the dissemination of the knowledge of blood donation. distinct promotion strategies should be adopted to increased first time and repeated blood donation among the youth. we advocate for similar initiatives in encouraging blood donation and disseminate knowledge among individuals in the community. dubai blood donation center, dubai health authority, dubai, united arab emirates background: dubai is multicultural city in united arab emirates. only about % of the population consists of uae nationals with the rest comprising expatriates from various countries all over the world. approximately % of the expatriate population (and % of the emirate's total population) are asian, chiefly indian ( %) and pakistani ( %). dubai blood donation centre is the only centre providing blood donation services in dubai. arabic is the national and official language and english is used as a second language. in order to have good quality screening, it is important that blood donors understand the educational material and questionnaire properly. aims: dubai blood donation centre receives donors (nationals, residents and gcc card holders) from various countries. the aim of this study is to analyze the multinational profile of donors and to find out the need to add any third language to meet the customer needs and expectations. methods: a cross-sectional study of blood donors was conducted in dubai blood donation centre in . the donors were asked about their country of origin, languages which they can read & understand and about the preferred mode of communication. results: a total of donors were surveyed and asked about the languages which they can read and understand and responses were obtained. the most common languages which can be read and understood by blood donors in dbdc are english (n = ; %), arabic (n = ; . %), hindi (n = ; . %) and malayalam (n = ; . %). the donors come from different countries, most common ( . %) donors are indian and ( . %) are from uae. it was found that % donors can read and understand only one language. majority ( . %) donors can read and understand either of the official languages arabic or english. however, ( . %) donors can't read and understand these two official languages, the other common languages being hindi and malayalam. the donors were asked about the preferred mode of communication, responses were obtained. the most common mode of communication were sms and telephone ( % together). summary/conclusions: based on the above findings, it can be concluded that the blood donor profile in our centre is multinational which is a unique and almost similar to the population profile of dubai. as . % donors can't read and understand arabic and english, so it has been decided that the educational material and questionnaire need to be prepared in one more language. hindi has been decided as the third language in the centre and donor questionnaire and educational materials in hindi will also be made available to the donors. further,the donors will be communicated through sms for routine messaging and disease notification while telephonic calls will be done only when the blood is urgently required. background: metabolic disorders (metds), including hypertension, dyslipidemia, hyperglycemia, and central obesity, are tightly associated with cardiovascular diseases and type diabetes mellitus. due to the sedentary lifestyle and increased consumption of high-calorie diet in modern society, metds have become serious health problems worldwide. to have a better understanding and possible improvement on blood donors' health condition, we conducted a survey of the prevalence of metds among blood donors in a blood donation station located in the hsinchu science park in taiwan. participants with metds will be provided with health education materials about metabolic risk reduction, in order to prevent the development of future complications. aims: the aims of this study were to determine the prevalence of metabolic disorders among blood donors, and to calculate how much money would be paid to identify a case of hyperglycemia, hyperlipidemia, or undiagnosed diabetes. methods: this study was approved by the institutional review board of taiwan blood services foundation (tbsf). the body weight, body height, waist circumference (wc) and blood pressure (bp) of participants were measured. blood samples were obtained to determine the values of hemoglobin a c (hba c) background: the law on blood donation supports the development of the blood service and guarantees the protection of the donor's rights and the maintenance of health during blood donation in the russian federation. national criteria for donor selection for blood donation are used in the activities of blood service establishments and are aimed at ensuring the blood products safety. the study of the characteristics of blood donors allows to predict the development of blood service and to plan the volume of blood products for transfusion and plasma fractionation. aims: the aim of this work was to study the characteristics of whole blood and apheresis donors in the blood service in the russian federation. methods: indicators of activity in the blood service establishments in the russian federation in sectoral statistical observations over the period - and the calculation of indices characterizing the whole blood and apheresis donors were analyzed. data are presented according to the administrative division of russian federation into federal districts (fd). results: the proportion of whole blood donors was . %, plasmapheresis donors - . %, blood cell apheresis, including plateletapheresis, donors - . %. for the period - , the percentage of repeated and regular whole blood and apheresis donors increased from . % to . %. the percentage of first-time donors ranged from . % to . %. the largest proportion of plasmapheresis donors was observed in the volga fd ( . %). about . % of the total plasma was collected by apheresis from donors. the percentage of plateletapheresis donors increased from . % to . %. the largest percentage of plateletapheresis donors was observed in the central fd ( . %), where a significant part of medical centers of cardiac surgery, hematology and bone marrow transplantation are located. the proportion of platelet concentrate collected by apheresis increased to . % in . actions to recruit young donors for blood donation and its components were regularly carried out in all federal districts. summary/conclusions: in the russian federation, the structure of donation is characterized by an increase in the proportion of plateletapheresis donors, stabilization of the percentage of plasmapheresis donors and an increase in the proportion of repeated and regular whole blood and apheresis donors. there are significant regional variations of donor's characteristics in the federal districts. background: shortage of blood supply despite continuous blood donation campaigns especially during local festive seasons has been a major issue in our country. thus, our faculty initiated blood donation drives in collaboration with national blood centre in order meet the demand for the blood requirements. however, the pre-donation deferral rate was relatively high among our young blood donors leading to loss of valuable blood units. understanding the causes of donor deferral provides direction on strategies for young donor recruitment and retention of future blood donation. aims: the aim of this study is to evaluate the young donor deferral pattern and to identify factors which could help in minimizing the preventable deferrals. methods: this is a retrospective study of voluntary young blood donors age between to years old recruited during mobile blood donation in faculty of medicine, universiti teknologi mara, malaysia. the study was conducted between january to december . the data were retrieved from the official reports of each mobile blood donation. results: a total of young blood donors had attended mobile blood donation during the study period. the overall pre-donation deferral rate is . %. the main causes of deferral are low haemoglobin (hb) level ( . %) followed by low blood pressure ( . %), upper respiratory tract infection ( . %) and sleep less than h ( . %). summary/conclusions: low haemoglobin and low blood pressure are the two common reasons for blood donation deferral among our young blood donors. in our study a significant proportion of deferrals are due to sleep less than h whereby this could be prevented if the donors are aware of the donor selection criteria. strategies to mitigate preventable deferrals and improve blood donor retention particularly young blood donors as source of motivation for future blood donation are urged to avoid additional stress on the blood supply. background: in the modern world, donating blood has become a humane manner for saving of patients life. but there are barriers to blood donation which are designed to ensure both donor and blood recipients' safety. anemia is one of the most common health problems in the world. based on the who estimation, nearly a quarter of the world's population are suffering from anemia, its prevalence varies among the populations and age groups. the prevalence of anemia among men is . % and in non-pregnant women is . %. aims: the aim of this study was to determine the status of hemoglobin in volunteer blood donors referring to fars province blood transfusion service and to determine the demographic status of them during the last two years. our study included blood donors for all blood donors during the last two years. methods: the study is descriptive cross-sectional and our sampling was non-random and simple sampling method. all parameters related to the donors, including age, sex and type of donation were investigated and analyzed in spss software. results: the total number of referrals for blood donation was . repeated blood donors was . % of total population and had the highest number of referrals, followed by first and lapsed donors with . % and % respectively. in terms of gender distribution, . % were female and . % were male. the highest rate of hemoglobin level less than . g/dl was found in first-time donors with . % and the lowest prevalence was observed in lapsed donors, followed by repeated donors with . %. . % of the repeated blood donors have hemoglobin higher than . . there was a significant difference between blood donation type and hemoglobin level. summary/conclusions: according to our findings, low hemoglobin levels are more common among first-time and female donors, and this requires a special training among these groups. because the high share of first time donors in blood supply and the positive impact of female donors on the blood safety, corrective action for that groups is recommended. finnish blood donor biobank j partanen, t wahlfors, m arvas, j clancy, k l€ ahteenm€ aki, e palokangas and n nikiforow background: the increasing need for large, well-characterized cohorts of healthy individuals for modern biomedical research, such as genomics or phenomics studies typically including tens or even hundreds of thousands of subjects, has posed the possibility of using blood services as an option for collecting samples and related data. the possibility to re-contact blood donors for repeated sampling or asking for additional data has further increased interest in collecting large biobanks from blood donors. there is also a need to study more thoroughly the effects of blood donation on donor health. aims: the first-phase goal is to recruit , blood donors with broad biobank consent for the finngen (https://www.finngen.fi/) project, a large publicprivate effort aiming to collect genome and health-related registry data of % ( , ) of the finnish population. ( . %), dental examination ( . %) and medication history ( . %). permanent deferral namely, risk factor involving transfusion transmitted infections and chronic disease were ( . %) and ( . %) respectively. the prime cause of permanent deferral was risk factor involving transfusion transmitted infections while the temporary deferral was bed side hypertension. gender wise, the leading cause of donor deferral in male was bed side hypertension and anaemia was the major cause in female. summary/conclusions: the findings of the survey aid to evaluate the significant causes of blood donor deferral. this study suggests that the restrictive criteria can be used for blood donor selection. this will in turn increase the blood supply of tertiary care hospital. background: donor selection is the first step towards safe blood but retaining blood donors is also very important for the blood supply. donor questionnaire and the medical interview should provide optimal doctor deferral. aims: to evaluate deferral rate in blood donors in order to identify the main reasons and to target eventual corrective activities. methods: we analysed the data concerning blood donors who were registered in the period of three years ( - ). we used data from the information system e-delphyn. background: iron deficiency (id) in blood donors is an underestimated issue in many countries and may cause symptoms to blood donors even without anemia. id prevention is mainly based on the prevention of anemia in whole blood donors, which is done by deferring donors whose haemoglobin level is under defined threshold ( g/l in women, g/l in men in france). efs (french blood establishment) studies has observed that the rate of deferral for anemia is significantly higher in women than in men, either in french west indies ( . % versus . %) or in continental france ( . % and . %). assessing the prevalence of id is of great interest since strategies to counteract it must deal with donor health and self-supply. however, data on id are missing in france. aims: to estimate the prevalence of id in french whole blood donors and to identify risk factors associated with id. methods: this non-interventional, cross-sectional, multicenter study is performed in blood donors of efs and ctsa (blood center of the french military health service). all whole blood donors who met selection criteria are potentially included. donors coming for bloodletting and donors who refuse to participate to the study are excluded. no additional sample is taken for the study, ferritin is tested after blood qualification on surplus amount. samples are selected at random within all the geographical areas and all mobile blood drives and blood centers between march and march , . results: this study ferridon has been approved by ethical research committee. nine thousand ( ) whole blood donors will be included in efs centers in continental france. to have information on donors of afro-caribbean origin and comoros origin, donations should be included in the french west indies and in reunion island. additionally, whole blood donors will be included in ctsa centers. in this study, id is defined by ferritin lower than ng/ml and iron overload is defined by ferritin higher than ng/ml. all donors with iron deficiency or overload will received a letter advising to consult their general practitioner. weights will be calibrated on age, sex and geographical area so the sample will be representative of the french whole blood donors. estimation of id prevalence will take into account the weights and logistic regression model will be used to analyze risk factors associated with id. data will be analyzed during april and may to get result at the end of may. summary/conclusions: ferridon will be the first study on id in the french blood donors. considering the french health care system and diet, it will be interesting to compare those results to results from other countries. mostly this study will allow to consider various strategies dealing both with donor safety and self-supply. background: in portugal, with an aging population of around million people, only . % are blood donors. the country has a national center of blood supply and some central hospitals with a blood donation center. despite the growing practice of the excellent concepts of patient blood management, it is imperious to attract new donors. this need has been our inspiration to use new approaches towards people, in a constant work of promotion. aims: reach the majority of our local population using radio and telecommunication as well as social networks in an attempt to raise the number of new blood donors in a central hospital of the north of portugal. methods: active communication with the population of our reference area, via the social networks facebook tm and instagram tm , through educational digital posters and messenger service to answer any kind of questions. establish contact with radio and television stations as well as with the mayor of the city, journalists, schools, town hall deputies and celebrities, through email and telephone calls. design posters, flyers and public advertising to distribute in the city. results: through the social networks it has been possible to reach a population of dozens of thousands in our city, in a daily basis. the national and world donor days were celebrated with success, in our health facility, with city mayor and journalists, and also in three television stations with national broadcast, reaching millions of people. celebrities (sport, television, music, stand-up comedy, journalists and a magician) have accepted our challenge through videos or donating blood, appealing to blood donation and sponsoring our cause. these projects and continuous availability to innovate have given our hospital a self-sufficiency of % in , instead of % in , which implied receiving less blood unities from the national center of blood supply. our most recent project involves high schools, in an attempt to educate our next generation of donors, with meetings in the town hall with deputies and district school delegates. summary/conclusions: the aging population and the low percentage of blood donors are an important issue concerning public health. nevertheless, the good will and continuous advertising and educative work towards the population, appealing to the ethical and civil responsibility since young ages have shown to improve our capacity of response as a central hospital, increasing the auto-sufficiency of blood unities and the interest of younger donors. it is of the utmost importance to understand that this is a continuous and a hard work of the professional team of our hospital, involving countless calls, emails and hours to obtain some positive response, in an endless job. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the mean interval between donations is shorter for former regular donors ( . months, p < . ) whereas donors with an interval of to months are more likely to be regular (aor ; % ci . - ). summary/conclusions: at the provincial blood transfusion centre of bukavu, the percentage of regular donors is low and there is a substantial loss of former regular donors. some factors identified to be linked to fidelity are unique to our study: female gender and a longer interdonation interval. other factors that are similar to those found elsewhere have a particular significance in our donor population which consists mainly of young people and people without income. efforts must be undertaken to ensure a supply from voluntary donations; recruitment strategies and target groups must be refined. future qualitative studies are needed to explain the various associated factors and better understand the motivations of regular and non-regular donors to improve donor retention. results: in kazakhstan, the proportion of donors is higher, especially primary. the number of blood and especially plasma donations is higher, which can be explained by the presence of several albumin and immunoglobulin production sites. increased evidence of blood transfusion rules, the development of a patient's blood management in combination with an increase in the quality of blood components cause a reduction in clinical need for red blood cells and plasma for transfusion. at the same time, the need for platelets is growing. it is difficult to assess the correctness of comparing the amount of banked whole blood. it is equally difficult to compare the number of received and distributed donor red blood cells and plasma: in russia they are measured in liters, and in kazakhstan in doses. with a certain degree of conditionality platelet extraction can be compared. in russia, they are counted in equivalent doses isolated from a dose of whole blood (at least cells per dose), and in kazakhstanin therapeutic doses (at least cells per dose). in , the estimated consumption of platelets in kazakhstan exceeded the russian indicator by . %. % of platelets in kazakhstan and . % in russia are harvested by the apheresis method. inactivation of pathogens is performed in % of platelets in kazakhstan and in . % in russia. pathogen inactivation with amotosalen allows us to abandon the examination of donors for cytomegalovirus and irradiation of platelet concentrate. the main modern trend in the use of cryoprecipitate is using it as a source of fibrinogen, a blood coagulation factor that is first depleted in coagulopathy associated with injury and massive bleeding. its production is growing in both countries, endowment in kazakhstan in exceeded the russian indicator by . %. a significant plasma percentage in both countries does not pass quarantine due to repeated non-appearance of the donor and is subject to destruction. inactivation of pathogens is performed in % of plasma in kazakhstan and in . % in russia. despite the instruction and selection of donors, laboratory screening of infection markers remains effective: russia more often identifies hiv and viral hepatitis c from potential donors, and viral hepatitis b and syphilis are detected in kazakhstan. . % of donors in kazakhstan are exempted due to the results of multiplex screening of nucleic acids of three hemotransmissive viruses. summary/conclusions: the blood services of russia and kazakhstan perform tasks to provide medical organizations with effective blood components. in conditions of decreasing demand for red blood cells and plasma, it is advisable to focus on the efficiency of resource use and improving the quality of blood components produced. blood collection including apheresis p- finnish red cross blood service, helsinki, finland background: skin disinfectant must effectively reduce microbes from the arm of the donor. as a result of poor disinfecting microbes may be transferred from skin via venepuncture to the collected blood and contaminate the blood components. aims: to ensure the efficiency of the skin disinfectant used for donor arm disinfecting by validation. the validation has two criteria which the post-disinfection samples must achieve: . no bacteria growth near the puncture spot (result cfu) in ≥ % of the samples. . total amount of bacteria on average is at most cfu/ cm . at most % of samples are allowed to have - cfu/ cm . methods: microbiological samples were taken with contact plates from voluntary persons' elbow folds before and after skin disinfection. the disinfecting was performed according to normal procedure by five nurses altogether with ethanol based disinfectant used in blood donation. on the sample plates an x was marked and this was directed to the puncture spot pointed by nurse. post-disinfection sample was taken at the moment the skin would be punctured with needle. results: the amount of bacteria varied from to above cfu/ cm in the pre-disinfection samples. disinfection reduced bacteria very well; the critical puncture spot was totally clean ( cfu/ cm ) in . % of the samples and . % of the samples had or only cfu/ cm . the average number of bacteria after disinfection was , cfu/ cm and the maximum number was cfu/ cm . most of the remaining bacteria were single colonies at the edges of the plates. summary/conclusions: both main criteria are fulfilled. the sub criteria of the second main criteria is also full filled if the not so critical colonies at the edges of the plates are not taken into account. the skin disinfectant in question is shown to be effective and can still be used in blood donation paying attention to thorough procedure performance according to the instructions and sufficient drying time of the disinfectant. background: research questions involving blood donation and recipient data often require advanced statistical methodologies. while such methodologies may appear in other medical research areas, specific tailor-made statistical tools and approaches are required for the analysis of blood-related data. these toolkits, which often require collaboration, are not always readily available to blood services, especially so in resource-limited settings. an international network of statisticians, epidemiologists and clinical researchers has been established for this purpose, which started with an invited session at the meetings of the international biometric society. aims: to exchange ideas, experience and knowledge to further improve the quality of blood sector research. methods: currently our network covers four major blood services and members from five different countries. the network has monthly conference calls about past and current research topics. we wish to extend this network further, and establish a subcommittee on statistical and epidemiological methodology with regular face-toface meetings at an international organization such as isbt. results: the monthly meetings have already demonstrated that the members share common problems and interests. for example, we are discussing techniques to analyze data with repeated measurements, e.g. eligibility haemoglobin tests, ways to assess the healthy donor effect, e.g. determining appropriate controls groups, and predictive models of blood supply and demand, e.g. stochastic processes and queuing models. the network also aims to organize training sessions in methodology either on site and/or by developing web lectures. summary/conclusions: an international network on statistical methodology for the analysis of blood donation and recipient data will improve the quality of research in the field of transfusion medicine research. expanding the network to include countries and blood services in research limited settings needs to be actively pursued. background: blood donor hemoglobin concentration (hb) is commonly measured from a skin-prick sample at the donation site, and low hb is the most common reason for temporary donor deferral. while a proportion of the deferrals do reflect true low hb, the skin-prick sample is prone to preanalytical error and variation resulting in false deferrals. aims: we assessed the applicability of a venous blood sample for second-line hb screening in blood donors failing the initial skin-prick test. methods: initial hb was measured from a skin-prick sample with the hemocue hb + (hemocue ab) point-of-care (poc) device. donors with hb < g/l for females or < g/l for males or with a decrease > g/l from latest donation were included in the study. in the study group, a venous blood sample was collected for hb measurement with the poc device at the donation site. donation eligibility was based on this hb result. venous hb was also determined with a hematology analyzer (sysmex xn, sysmex co.). the blood service's current workflow served as the control group: two more skin-prick samples were collected and the donor's final hb and donation eligibility assessed with an algorithm based on all three skin-prick hb results. results: in the study (n = ) and control (n = ) groups, the proportion of male donors ( % and %) and the mean initial skin-prick hb ( g/l and g/l) were similar. significantly less donors were deferred from donation in the study group ( %) than in the control group ( %; chi-square test p = . ). the mean difference in venous hb with the poc device versus the hematology analyzer was À g/l (range À to + g/l). two donors were incorrectly accepted based on venous sample poc result; however, in both, hb measured with the hematology analyzer was only g/l below the limit of donation eligibility ( g/l for a female and g/l for a male). interestingly, a further donors ( % of all deferred in the study group) would have been eligible for donation based on the hematology analyzer result. summary/conclusions: utilizing a venous blood sample for second-line screening of donors failing the initial skin-prick hb test significantly decreased low hb deferrals without compromising donor health. blood donors' and blood service nurses' reactions to the new workflow have been favorable. we conclude that valuable donations can be recovered and donor satisfaction increased by implementing a second-line hb screening model utilizing venous sample analysis at the donation site. background: there is a paucity of literature on haemoglobin (hb) reference values for adults above years of age. this age group has been reported to use up to % the blood supply. some studies report a decline of mean hb with age, but others have found no change with age. conflicting findings of hb levels in the healthy elderly population may be associated with challenges in accessing data from healthy older adults, small sample sizes, selection bias and recent health population data. to donate blood, each individual is assessed as 'healthy' and must meet the minimum hb criteria. however, the hb criteria across countries vary and many blood collection services have an upper age limit for donors. as many populations around world are aging, restricting the upper age limit for blood donation may potentially affect the size of the donor pool and consequently the nation's blood supply. aims: to explore the hb levels of healthy older adults, through a multi-centre retrospective observational study of blood donors aged years or older. methods: over a one-year period, hb values were collected from blood donors aged ≥ years from blood centres of four countries. the estimated proportion of blood donors aged ≥ years old for each country was . % in south korea (sk); . % in hong kong (hk), < . % indonesia (indo) and % in japan (jap). the minimum hb criteria varied between each country and ranged from . - . g/dl for women and . - . g/dl for men. hb levels were determined using point of care testing (hemocue, compolab, hemcontrol) or the xe- d sysmex dependant on the country of origin. statistical analysis of the mean, standard deviation and cumulative distribution of hb were determined by gender and age. background: medication usage is assessed to determine donor eligibility from the perspective of both recipient and donor safety. different time frames since last taken apply to different medications. assessment of medication use varies by jurisdiction, but most european centres use multiple questions. these often include a general question about recent medication use whereas the usa does not. at canadian blood services there are medication questions on the donor history questionnaire (dhq), including any medication use in the last days, vaccination and specific medications over different time frames (high teratogenicity medications). the name of each medication taken and reason for use are documented by staff at each donation attempt. assessment of the frequency with which this process occurs is the first step in improving efficiency of this aspect of donor screening. aims: to determine the percentages donors answering yes to medication questions by demographic variables. methods: all whole blood donors who completed the dhq (full length or abbreviated) in were included in the analysis. donors' answers to each of the medication questions were extracted from the national epidemiology donor database, as well as sex and age. the number and percentage of donation attempts in which a donor answered yes to each medication question were calculated. donors who answered yes to any medication question were sorted by sex and by age group, the totals and percentages calculated. results: there were , donation attempts with a completed dhq. overall, % of donors answered yes to medications in the last days, % to vaccination, and less than . % to others ( % any). slightly more were female ( vs %) of those who answered yes to any medication question, as well as by individual question. the percentage of donors answering yes to any medication question increased progressively in each age group from % of - year olds to % aged + (p < . for trend). summary/conclusions: more than one third of all donation attempts answer yes to a medication question and require further questioning and documentation. this is more common in older donors and follows a similar trend to general population medication use. comparison of ways of assessing medication use in different countries may help identify effective but more efficient approaches. in addition, the contribution to donor and recipient safety of assessing all medications should be assessed. blood center experience with trima accel and tomes software j schreier , a davison , j gambarte , y l opez , c calonge and e herranz terumo bct, lakewood, united states centro de transfusi on de la comunidad de madrid, madrid, spain background: in the madrid community, more than apheresis platelet collections were completed in , of which almost were completed in the blood transfusion center and the remainder in several hospitals in the region. trima accel was implemented to meet the productivity needs of the blood transfusion center while improving the donation experience. tomes (terumo operational medical equipment software), which enables bidirectional communication with trima accel devices, was used to connect and centrally manage all trima accel devices with automated data capture and reporting. aims: the aim of this study was to evaluate operational improvements using trima accel with tomes compared to trima accel version . methods: this was a retrospective study analyzing apheresis procedures on trima accel version during the control period from january to september compared to apheresis procedures on trima accel during the test period from september to december . this was not a paired study. operator interventions, and completed procedure rate comparisons, were analyzed using a -proportions test, whereas donor demographic data were analyzed using a -sample t-test. results: trima accel was used to collect single and double platelet products stored in platelet additive solution. operators selected either a single (target platelet yield = . or . ) or double (target platelet yield = . ) platelet donation based on desired procedure time not the maximum number of products that could have been collected per donor. no statistically significant differences were observed for donors in the test arm compared to donors in the control arm for total blood volume (control = ml, test = ml, p = . ), hematocrit (control = . %, test = . %, p = . ), or platelet pre-count (control = / ll, test = /ll, p = . ). females represented % of donors in the control arm compared to % of donors in the test arm. platelet split rate (platelet products per procedure) increased from . with trima accel version to . with trima accel ; procedure time decreased from . min to . min for single collections and from . min to . min for double collections with trima accel (these differences were not statistically significant). the percentage of procedures that completed with no operator interventions due to access alerts increased from . % to . % (p < . ) and the rate of completed apheresis procedures increased from . % to . % (p = . ) with trima accel . manual transcription of data during the procedure was discontinued with the implementation of trima accel with tomes. tomes captured procedural data and operator steps with barcode scanning and tracking of configured events. this information was transferred to tomes post procedure and printed as a final report. summary/conclusions: trima accel significantly decreased operator interventions, and automated data capture with tomes eliminated manual transcription of data. both outcomes freed operators to complete other tasks and focus on donor well-being. background: the european committee (partial agreement) on blood transfusion (cd-p-ts) of the council of europe (coe) has appointed a working group (wg) to focus on issues with plasma supply management (psm). the task of the wg is, among others, to collect and analyze data in order to fill knowledge gaps concerning donor safety in plasmapheresis. in doing so, the working group will gather evidence base data to support the upcoming revision of the th edition of coe's "guide to the preparation, use and quality assurance of blood components", the blood guide. an international survey was conducted sept-dec , distributed to blood establishments (bes) by the cd-p-ts representatives to coe's member and observer states. the questionnaire included sections covering collection practices (volume and frequency), management of red cell loss, donor panel demographics and data on donor adverse events. aims: the aim of this study was to investigate whether collection practices following the recommendations published in the blood guide for maximal collection volumes and number of donations per year were indeed associated with higher levels of donor safety and improved donor base sustainability. methods: from the total of respondents, bes collected plasma for fractionation (pff) by apheresis and the study had a dataset covering , , plasma donations in the latest fiscal year (lfy). the parameter used as marker of donor safety was the rate of immediate vasovagal reactions with loss of consciousness (vvr with loc) per , plasma collections. the parameter used as marker of donor base sustainability was the retention rate of donors, ie % donors active in the previous year returning to make a donation in the lfy. results: in the blood guide, the collection volume per apheresis is limited to % of the estimated total blood volume but maximally ml, including anticoagulant. respondents had differing practices and scale of collection program be were aligned or lower, and be had higher collection volumes. altogether reported the immediate vvr with loc rate, which mainly was lower than / collections. there was a small trend towards reduced rate with larger collection volumes than allowed by the current blood guide. saline compensation during or after collection did not affect the rate of vvr with loc. no correlation was observed between the annual donor retention rate and the rate of vvr with loc or saline compensation practices, as reported by respondents. the retention rate banded in the range of %> % (mean = %, min = %, interquartile range = %, max = %). the association between maximum allowed yearly plasma collection ( l) appears to be reasonably constant and showed no clear association with the donor retention rate. summary/conclusions: restricting the maximum collection limit according to the current blood guide was not associated with either lower vvr with loc or with higher donor retention rate. this study supports reassessment of current blood guide s limits for collection volume of maximum of ml per donation and l per year per donor. methods: serum ferritin concentrations were established from sera stored at À °c from repetitive platelet donors between and , using architect â ferritin assay chemiluminescent microparticle immunoassay (cmia). the hematimetric parameters were evaluated in a total blood sample using the celldyn â . sixteen samples were obtained from women (age: . ae . years, range: - ) and samples from men (age: . ae . years, range - ), corresponding to . % and . % of the total female and male repetitive donors of platelets by apheresis using trima accel â terumo-bct and amicus tm fresenius-kabi. the difference in the concentration of serum ferritin between the last and first donation was established, as well as the change in the predonation platelet count between the last and first event. results: in the study population, . % of women and % of men performed repetitive donations of platelets by apheresis with an interval of less than three months. the change in ferritin concentration was evaluated according to the interval between donations. in women ferritin delta was À . ae . ng/ml when the donations had an interval less than three months, vs . ae . ng/ml when the time between donations was higher (p = . ). in men the change in the ferritin levels was À . ae . ng/ml with donation times less than three months vs © the authors vox sanguinis © international society of blood transfusion vox sanguinis ( ) (suppl. ), - À . ae . ng/ml with prolonged donation times (p = . ). in women, the change in platelet count was À ae . /ul, when the donations had an interval less than three months vs À ae . /ul when the time between donations was greater (p = . ). in men, the delta of the platelet count was À ae . /ul in donation times less than three months vs À ae . with higher donation times (p = . ). no correlation was found between the concentrations of serum ferritin and the platelet count (r = . , q = . for males, and r = . , q = . for females). summary/conclusions: the data obtained suggest that repetitive donation of platelets by apheresis with intervals between donations of less than three months, significantly reduce serum ferritin concentrations in women and men, although normal levels were maintained in both groups. there was no correlation with platelet count. therefore, it is proposed to develop prospective studies to establish the minimum time interval safety for platelet apheresis donor procedures. background: the demand for platelets concentrates is increasing continuously and becomes a challenge for the blood establishments. apheresis platelet collections may be a solution for this challenge. improving apheresis collection efficiency while maintaining blood donor safety is an important goal for the service du sang of the belgian red cross. aims: our establishment evaluated the improvements of the trima accel automated blood collection system version (ta ) by comparing its routine performance with that of the previous software version . (ta ). methods: prospective, multi-site, controlled, non-randomized trial. apheresis collections were performed in three sfs sites: liege, mons and namur using the two trima software versions ta and ta sequentially. data were collected from december to april on ta and from june to july on ta . simple and double doses of platelets (respectively . , . and . , . ) were collected in platelet additive solution (ssp+, macopharma) with concurrent plasma from the same cohort of donors in accordance to donor's eligibility and preferences. in order to maintain the same final platelets content in platelets concentrates, the trima accel's tool yield scaling factor (ysf) was subsequently adjusted from . (ta ) to (ta ). platelet yield, duration of procedure, number of alarms requiring operators' interventions were recorded and evaluated. donor's hypocalcemia was avoided by giving preventively oral or intravenous calcium which was documented by the operators. results: five hundred ninety ( ) collections with ta and with ta were recorded, with % and % complete procedures respectively. mean duration of procedures was min on ta against min on ta , p < . . the mean alerts number per procedure on ta was . against . on ta , p < . whereas the maximum alerts number per procedure was and respectively. on ta , % procedures did not require operator's intervention against % on ta ,. with ta the inlet flowrate was automatically adjusted in . % procedures. the inlet flowrate was increased in response to access pressure in . % of procedures, for % of the procedures the inlet flowrate was decreased and for . % of the procedures the inlet flowrate was increase and decreased on the same procedure by the ta autoflow system. summary/conclusions: ta with its autoflow function improves apheresis donors experience while decreasing operator' interventions through a significant reduction of access draw alerts. as expected from the trima accel platform, post-donation safety remains high. a weak increase in procedure duration was observed for the same platelet yield which may be resolved with further adjustments. background: trima accel system is an apheresis platform relying on continuous flow centrifugation to collect from a donor platelets, plasma or rbcs based on donor qualification. the latest software version -trima accel (ta ) introduced the autoflow feature which allows for automated flow rate adjustments. moreover, ta leverages the mobilization capacity of the spleen increasing potential platelet productivity while maintaining high post-donation safety standards characteristic of trima accel. aims: the objective of this evaluation was to assess the impact of ta software by retrospective comparison of procedure data and potential for increased productivity with those of trima accel version (ta ) in the same cohort of platelet donors. methods: eight hundred twenty one procedures, started on ta from th january to th october were compared to procedures, started on ta from th october to st december . procedural data from the trima devices were captured using the cadence system (terumo bct, lakewood co). parameters investigated were the number of machine access pressure alerts per procedure, the potential for higher platelet yield collections and the actual collected yields within the same cohort of platelet donors. results: both donor populations (ta vs. ta respectively) were comparable and were characterized by: tbv - vs. ml; platelet count pre-procedure - ³/ll vs. ³/ll; hematocrit pre-procedure - % vs. %. gender distribution was % female with ta vs. % with ta . venous access pressure alerts were significantly improved by ta with an average of . alerts per procedure as compared to . with ta , i.e. % decrease. this decrease went down to % if only male procedures were analyzed. the maximum number of pressure alerts went down by % from alerts in one particular run in the ta cohort to alerts in one ta procedure. procedure time for single platelet products was reduced from to min and for double platelet products from to min (ta and ta respectively). donor qualification possible was % of procedures yielding single products and % of procedures yielding double products with ta . the percentage of procedures qualifying for doubles increased to % with ta . in terms of split rates, i.e. how many platelet doses could be produced per apheresis collection, potential split rates increased from . to . from ta to ta , respectively. in fact, the observed split rate rose modestly from . to . , as shorter procedures were generally selected according to donors' preferences. summary/conclusions: in comparable donor populations, implementation of ta decreased the number of access pressure alerts significantly compared to previous trima versions. the average procedure duration was also found to be slightly reduced. implementation of ta has the potential to increase productivity significantly. the observed modest actual rise in split rate suggested that factors related to donor and inventory management will determine at which extent the potential of the new software will be used. donor compared experience on trima accel to trima accel version august to october or trima accel during the test period from november to january . this was not a paired study. donors completed the survey while recovering from the apheresis procedure in the cantina. results from the paper survey were transcribed into excel for analysis. results: donors completed the survey during the control period whereas donors completed the survey during the test period. the mean number of previous donations for the control period was . (min max ) and for the test period was . (min max ). there were no first time donors during the control period and first time donors during the test period. % of donors rated their overall donation experience as good on trima accel compared to % on trima accel version . zero ( ) donor rated their experience on either trima accel device as poor. % of donors who responded to the question said they would donate on trima accel again. summary/conclusions: no significant difference was observed in donor experience between trima accel version and trima accel as both versions receive high marks. background: the trend on growth of query for donor platelet concentrates is observed in russia for past few years. as reported by edqm in , a higher number of the platelets was consumed compare to by . %. patients' with hematological malignancies treatment requires platelet concentrates transfusions during chemotherapy, immunotherapy and hematopoietic stem cells transplantation. according to the data collected in national research center for hematology (nrch) in , ( . %) of the , patients, treated within facility, received platelet transfusions as transfusion therapy. the total number transfused units is , , which is higher (by . %) comparing to . platelet concentrates production can be performed either by apheresis process or by pooling individual units recovered from the whole blood. taking into account that the nrch produces blood units for its own needs, the pooling is not suitable method for production because its implementation doesn't cover require for platelets and overproduces rbcs. that is why platelet concentrates in nrch are obtained by apheresis only. in summary, the growth on requirement for platelet concentrates and their safeness explains the need for a comparative study for effectiveness of platelet production using various apheresis systems. aims: the aim of the study is to compare effectiveness of platelet concentrate production using mcs + (haemonetics), upp and trima accel (terumo bct) version . protocols. methods: the data for protocols of platelet donations performed in were analyzed: on trima accel and on msc + . all donors were voluntary and non-paid donors with previous experience of blood donations. the choice of the platelet collection device was random; analysis of the main characteristics of donors did not reveal any significant differences between the groups. the median age of the donor was years old, height - cm, weight - kg, platelet count before donation - /l, hematocrit - %. detailed data are presented in table . student's t-test for unrelated sets was used for statistical analysis of the data. a value p of less than . was considered as significant. results: the data obtained showed significant difference (p < . ) between average number of platelets collected on trima accel ( . ae . /l) and on mcs + ( . ae . /l). while cost of consumables are comparable, trima accel demonstrated . % higher efficiency. procedure duration also was comparable and averaged within min for both devices. detailed data are presented in table . it is crucial to mention that proportion of trima accel's donations was significantly increased in nrch during and reached , % in total ( - . %). a flexible usage of trima accel's consumables for different procedures (regular platelet collection and collection in pas) allowed to change the pas/regular platelets collection ratio from . % up to . %. summary/conclusions: obtained results proved the effectiveness of the trima accel's use for platelets concentrates production. it allowed to increase the average count of platelets obtained for one procedure by . % compared to mcs + while the cost of consumables and procedure duration are comparable. the donor's comfort during procedure did not affect either. in long terms increasing of number of platelets collected is reducing the cost of platelet concentrates production. abstract withdrawn. background: apheresis collected platelet concentrate is preferable in terms of reducing the risks of adverse reactions in platelet transfusion when compared to random donor platelet concentrates. aims: the aim of our study is to present our experience in collection donation of single donor platelets with apheresis. methods: this is a retrospective study performed in the institute for transfusion medicine from till . all donors were fully informed on the donation procedure and signed an informed consent for donation. the optimal platelet count that we want to achieve was ≥ . equal to random donor platelet doses. minimum preapheresis platelet count in donors requested to start the apheresis collection was . /ll. platelet collection was performed using flow cell separators haemonetics mcs+ and trima accel. acid citrate dextrose formula a was used for anticoagulation. median precollection platelet count of donors was . /ll, with range from . /ll to . /ll. male were % of the donors and females were %. the single procedure usually took - min. the median platelet count collected was . , range - . . the median processed blood volume was ml and median used acd-a was ml. mean total volume of collected product was ml. the adverse effects included vein perforation and the numbness of the extremities as reaction of acd-a (hypocalcemia), which occur rarely and was very mild. summary/conclusions: the collected platelet count was more than the wanted optimum platelet count. the number of apheresis donors is increasing and we are working on expanding our voluntary platelet donors registry and increasing the number of typed donors in the registry. background: to determine value of hemoglobin in blood donors, there are some tools or methods used, such as: cyanmethemoglobin method that can detect of hemoglobin quantitative and methods cupric sulfate solutions (cuso ) can detect of hemoglobin qualitative. according to who (world health organization) to determine the level of hemoglobin in blood donors enough used cuso solutions with specific weight (y) . can to detect value of hemoglobin above or same with . gr/dl. but, cuso solution specific weight . can not to detect and elimination value of hemoglobin above gr/dl or polycythemia sick. because it, central blood transfusion unit (utdp) as the central of blood service in indonesia to manufacture cupric sulfate solution (cuso ) with a specific weight (y) to detect value of hemoglobin below gr/ dl and determine value of hemoglobin above gr/dl. because it, do the testing the accuracy of the solution cupric sulfate in detecting and eliminating donor with value of hemoglobin above gr/dl with the test of samples. aims: to determine accuracy and effectiveness by blood donors unit in indonesia red cross to use cuso solution with specific weight . in to detect and elimination value of hemoglobin donors above gr/dl. methods: used the method cyanmethemoglobin and cuso (y) . determination value of hemoglobin donor. test results were analyzed with spss software version using nonparametric analysis wilcoxon test. results: this research testing the accuracy and effectiveness of using a cuso solution with specific weight (y): . in detecting and eliminating hemoglobin value donors above gr/dl. from data processing using spss with the wilcoxon test p value . . summary/conclusions: it was found that the cuso solution (y): can detect hemoglobins value above gr/dl and more effective in checking the hemoglobin in blood donors. it can be seen from the data processing with spss version with the wilcoxon test p value < . . it is important to monitor the precise course by which repeated blood donation affects hb and the probability of low hb deferral. zinc protoporphyrin (zpp) is a functional indicator of body iron levels and is hypothesized to predict hb levels among blood donors. advanced statistical methods are necessary to properly analyze the longitudinal associations between zpp and hb in data with repeated donations per donor. aims: to determine whether predictions of future hb levels using current hb levels can be improved by taking zpp levels into account, and to illustrate the use of statistical models for repeated measurements of blood donors. methods: we used data from the zpp and iron in the netherlands cohort (zinc) study. we identified previous zpp levels (log-transformed) as the main predictor and adjusted for previous hb level, age, day and time of donation, donation history, bmi, blood volume and blood pressure. we used linear mixed models, which take into account missing data in the outcome and associations between repeated measurements, to investigate the longitudinal association between previous zpp and current hb levels. the longitudinal analysis with linear mixed models was contrasted with a simpler analysis based on the area under the receiver-operating-characteristic (roc) curve for the probability of low hb deferral. results: in total, whole blood donors ( , whole-blood donations) were included in the zinc study, % being female donors. previous zpp showed a statistically significant association (p < . ) with hb levels in females, but the size of the association was quite small (regression coefficient, b = À . , % confidence interval À . to À . ). the same was true for males, but the size of the association was even smaller. blood volume and age for women were significant secondary predictor variables; blood volume, age and donation interval for men. by comparison, the roc analyses showed relatively larger, but less statistically significant predictive effects of zpp on hb. summary/conclusions: zpp is a statistically significant predictor of hb levels, but the size of the effect after adjustment for previous hb and other variables is small. the results cast doubt on whether zpp is an effective predictive marker for hb level and low hb deferral, and suggest that zpp should not be included in prediction models for hb levels. by properly adjusting for associations between repeated measurements and by using all available data, longitudinal models provide less biased and more precise estimates than simpler cross-sectional analyses. background: finnish red cross blood service (frcbs) is a national blood service and is responsible for all blood collection and component production in finland. the highest age for blood donors was years until the end of year and since beginning of donors between and years have been able to donate blood. blood donation after the age is possible if the donor has donated within the last months. the upper age limit was raised up based on adverse event data from frcbs donors up to years and on published data from other blood establishments. aims: the aim of this study is to find out if the new policy from with upper age limit of years is safe. therefore donor adverse event data was analyzed in order to evaluate if the blood donors older than years have more adverse events compared to other donors. the most common donor adverse event for donors over years, haematoma, was registered times ( . %). in the other age groups haematoma was registered times ( . %) and the difference between the oldest age group compared to all other donors was statistically not significant (chi , p = . ). vvrs with loc were registered times ( . %), vvrs without loc times ( . ), and the total number of all daes was ( . %) in the age group years or older. the respective numbers in the other age group were: , . %; , . %; ( . %). the number of vvrs with and without loc, and total number of all daes in the age group years and older was smaller than in the other groups and the difference between these groups was statistical significant (chi , p < . ). summary/conclusions: donors over the age of years have less donor adverse events than other age groups. decision to raise the age limit from to seems proven to be right as the older age group has even less donor adverse events than other donors. background: deep vein thrombosis (dvt) of the donor's phlebotomy arm is a rare, but serious complication of blood donation that needs to be recognised and managed appropriately in a timely manner. post donation dvt will be classed as a 'serious adverse events of donation' (saeds)these are events that either result in donor death, hospitalisation, intervention or significant symptoms persisting for more than one-year post donation. aims: to review cases of dvt post donation reported in uk in - years and identify any common themes for improving practice methods: all data relating to saeds from the four uk blood services reported to shot in the last years ( - inclusive) were reviewed to look for reports of dvt post donation results: a total of saeds were reported in uk from approximately . million donations (whole blood and apheresis) collected during this period. three cases of upper limb dvt were reported during this time accounting for % of the saeds reported and rate of dvt of in . million donations collected. -case : a regular male whole blood donor in his early s reported worsening arm pain days following blood donation, had a painful venepuncture and a small bruise at site of donation. he was diagnosed to have an upper limb dvt extending to the subclavian and brachiocephalic vein and started on oral anticoagulants. no other contributory factor was obvious -case : a female donor in her mid- s gave her sixth whole blood donation without event. days after donation, she developed worsening arm pain in the donation arm and was diagnosed with an upper limb dvt and commenced oral anticoagulation. there was no other identifiable risk factor for the thrombosis -case : a female donor in her s developed pain, swelling, redness and itchiness in her donation arm and chest wall two days after donation. she also described prominent veins on the affected side compared to her other arm. she contacted the transfusion service one week after donation; by this time she was also breathless on minimal exertion. she was admitted to hospital and commenced on anticoagulant therapy. a diagnosis of dvt and associated pulmonary embolus was confirmed. the donor's only risk factor for thrombosis was use of the oral contraceptive pill. summary/conclusions: rare complications of blood donation, like dvt, can occur. superficial venous thrombosis may occasionally progress into the deeper veins of the donor's arm but dvt can also occur without signs and symptoms of superficial thrombosis. none of our patients had any overt evidence of superficial thrombosis. one patient in our series reported using oral contraceptive pill. no other risk factors for thrombosis was forthcoming. transfusion services should encourage donors to make early contact with the blood service if they experience arm complications so that they can be investigated and managed in a timely manner. staff dealing with such donors must recognise the possibility of this rare complication, explore other additional contributory factors and initiate prompt and appropriate management. background: voluntary blood donation is widely considered to be safe with very minimum chance of adverse reaction, which may occur during or after the end of phlebotomy procedure. aims: to find the adverse blood donor reaction among voluntary blood donors in tertiary care hospital in kathmandu methods: this is a prospective study done among voluntary blood donors at grande international hospital, kathmandu, nepal from february to march . the outlines of reported and communicated adverse donor reaction were also collected after the blood donation from voluntary blood donors in different locations including outdoor and in-house blood donation drive results: in the present study , whole blood donors were included, during the period of years, ( . %) adverse donor reactions were reported. majority ( . %) of adverse donor reactions were mild in nature such as, sweating; ( . %), light headedness; ( . %), nausea and vomiting; ( . ), allergy and bruises; ( . %), sore arm; ( . %) and hematoma; ( . %) while ( . %) were severe adverse reactions similarly, anaphylaxis; ( . %), loss of consciousness; ( . %) and convulsive syncope; ( . %). markers of the adverse donor reaction were age, sex, pulse, weight, blood pressure and donation status. age and first time status were related with significantly higher risk of adverse reaction with - years old at higher risk compared to - years old. first time donors were at higher risk compared to repeated volunteer donors. summary/conclusions: the results of the study are helpful to identify and understand the complication of adverse donor reactions though the incidence of reactions in the blood donors is lower than in other studies. donor age and donation status were strong possibilities of complications. background: blood donors with pollen-induced allergy and asthma must often refrain from donation in pollen season despite medication, because of symptom severity or similarity to airways infection. extracts of the medicinal mushroom agaricus blazei murill (abm) given orally have been found to reduce ige anti-ovalbumin levels and ameliorate the skewed th /th cytokine balance in mice sensitized to ovalbumin (takimoto, immunopharm immunotox, ; ellertsen & hetland, clin mol allergy, ). aims: the objective was now to examine whether supplementation with the abmbased extract that we used in the mouse model for allergy, could alleviate allergy and asthma in blood donors by reducing specific ige levels and basophil sensitization. methods: sixty donors at oslo blood bank with self-reported birch pollen allergy and/or asthma were recruited and randomized in a double-blinded, placebo-controlled study with oral supplementation for weeks before the birch pollen season with the abm-based extract andosan tm (immunopharma, oslo, norway). this is a water extract of the bacidomycetes mushrooms abm ( %), hericeum erinaceus and grifola frondosa. the participants filled in questionnaires for allergic conjunctivitis & rhinitis, asthma and medication. serum ige (immunocap â , immunodiagnostics, sweden) and bet v -induced basophil activation in whole blood determined by cd expression in a flow cytometer (flow cast â , b€ uhlmann lab ag, switzerland), were analyzed before and after the pollen season. (trial record: nct , clinical.trials.gov). results: there was significant reduction in allover allergy-related ailments and types of allergy medication used in the abm extract compared with placebo group during the pollen season and no side effects. also, abm treated asthmatics had fewer symptoms and used less medication than controls. in the abm group, serum levels of specific ige anti-bet v and anti-t , were significantly reduced during the pollen season as compared with levels in the placebo group. whereas the maximal allergen concentrations needed for eliciting basophil activation before the season changed significantly to lower concentrations (i.e. enhanced sensitization) after the season in the placebo group, these concentrations remained similar in the group given the mushroom extract. summary/conclusions: oral pre-seasonal supplementation with an abm-based extract for months reduced general allergy ailments, asthma symptoms and medication in blood donors with birch pollen-induced allergy and asthma during the pollen season. this was due to reduced specific ige levels and basophils rendered less sensitive to allergen activation. the study suggests that supplementation with abm mushroom extract can have prophylactic effect on aeroallergen-induced allergy and asthma in blood donors. it may therefore reduce such ailments in affected blood donors and impact blood donations in the pollen season. results: dhv started in / / . the data presented in this abstract is till / / . data is collected from total of blood donors ( . % male donors and . % female donors). repeat donors accounted for . % against . % of first time donors. of the total number of donor adverse events recorded, . % ( ) reported for male donors and . % ( ) for female donors when the donor adverse events stratified age-wise, the highest incidence reported in age group - years (male . % and female %). among age group - years, (male . % and female . %), whereas in age group - years, (male . % and female . %) data analysis of total reported and registered donor adverse events, are categorized as hyperventilation ( ), sweating ( ), dizziness (pre-syncopal ), loss of consciousness ( ), vomiting ( ), convulsions ( ), hematomas with re-bleed ( ), nerve irritation ( ) and off-site reactions ( ). many donors showed multiple forms of reactions. summary/conclusions: evaluation of donor side effects helps to improve donation process and donor compliance. most frequently recorded reaction remains dizziness (pre-syncopal). our donor vigilance data show reactions occurred more frequently in younger age, female and first time donors. repeat donation and age are predictors for low rates of adverse events. participation in dhv implies an effort to improve donor care and safety infrastructure and a desire for national and international comparisons to determine best practices and also to look into effectiveness of risk reduction strategies and follow-up trends. pre-donation hydration was implemented as an interventional tool to test the effects of hydration on pre-syncopal reactions to blood donation, specifically targeting those at highest risk such as female, first-time, high school donors. the results are awaited. background: descriptions of deferral categories and a knowledge in the percentage of deferrals in each category are of value in formulating recruitment and retention strategies. this can also help in planning more efficient recruitment strategies and thereby assist in reducing the shortage in blood supply. aims: the aim of the study is to categorize all donors who were deferred during medical checkup and find out the donor deferral rate in dubai blood donation center from january st to december st and also to find out whether there is any yearly or seasonal trend in any of the categories of deferral criteria's which can aid in forecasting and managing donor pool. methods: a retrospective study of donors deferred during last three years from january st to december st was done in dubai blood donation centre. the donors deferred during pre-donation medical check-up were categorized into categories including low hemoglobin, high and low bp, intake of antibiotic, fever and flu, taking other medications, travel history etc. the deferrals were analyzed monthly and yearly and then were compiled to find any yearly trend or seasonal trend in the donor deferral rate in any of the categories. the data were analyzed using the spss software and a p value of < . was considered significant. the assessment of donor suitability is in accordance with aabb standards and is consistently applied in every blood donation setting on each occasion of donation to all blood donors. results: during this study, , donors were registered from january st to december st and , ( . %) donors were deferred. the common reasons of deferral were low hb, high bp, travel history, intake of antibiotics and cough/flu symptoms. there was a significant decrease in deferral rate from . % ( / ) in to . % ( / )in and further to . % ( / ) in (p < . ). the specific deferral rate due to low hb also significantly (p decreased during these three years ( / in , / in , / in ), though no change was seen in the deferral due to other reasons. the reduction in the rate of deferral due to low hemoglobin may-be linked to the change in the staff performing the hemoglobin testing in dbdc (nurses instead of phlebotomist were assigned to perform hb estimation of donors). there was a seasonal variation in the deferral rate in all the three years-lowest in june ( / ) and then increasing with a peak in october ( / ) and plateauing till january. this pattern of deferral corroborated with the rate of deferral due to flu/fever and cough and antibiotics with an average of / in june and increasing to / in october (p < . ). summary/conclusions: staff competency is pertinent in accurately deferring donors. there is also a significant seasonal pattern in flu/fever and intake of antibiotics deferral rate that is reflected in the total donor deferral pattern. seasonal variation of specific category of donor deferral should be taken into account for donor recruitment and retention efforts. background: west nile virus (wnv) is a mosquito transmissible flavivirus. it has been shown (vogels thesis) that the common mosquito in the netherlands can transmit wnv in laboratory circumstances but presently does not lead to effective transmission. however, the number of outbreaks of wnv is increasing and moving from the eastern and southern european borders towards the traditionally more colder western and northern parts of europe. in order to prevent wnv transmission to blood transfusion recipients, dutch donors that travelled to regions with wnv risk are deferred for a period of days for whole blood, platelet donations and quarantine plasma in order to exclude potentially infected asymptomatic donors. aims: to assess numbers of dutch donors who are deferred for travelling to wnv risk areas within europe, and the return after onsite and offsite deferrals of donors. methods: data from to on donation attempts and deferral were retrieved from eprogesa, the blood bank information system. onsite deferral is defined as a donation that was attempted in the deferral period or in the days prior to deferral, all other deferrals are considered as offsite. a generalized estimating equation model was used to assess the association between onsite versus offsite wnv risk deferrals in - and subsequent return rates within two years (after which a donor is inactive according to domaine). results: in - , , donation attempts led to onsite deferral for wnv risk; % at whole blood donation attempts, % at new donor examinations. in total , offsite deferrals could not be traced directly to a donation, but based on the next donation more than % were probably whole blood donors. the number of deferrals peaks each year during august, the major holiday period in the netherlands, and increased from in august to in august . this increase is probably caused by the expansion of wnv risk regions. the return rate of wnv deferred whole blood donors is slightly lower than for donors who are not deferred ( % versus %); for wnv deferred new donors the return rate is % (versus % for no deferral). thus wnv deferral resulted in approximately - extra lapsing donors during these years. however wnv deferred donors, that are older (odds ratio (or) . ; % confidence interval ( % ci) . - . ), of male sex (or . ; % ci . - . ) and whole blood donors as opposed to new donors (or . ; % ci . - . ) were more likely to return to donate. there was no difference in return rate by offsite and onsite deferral. summary/conclusions: travel-related wnv deferrals are increasing with expanding risk regions, especially in the holiday season where the availability of donors is already low. although the numbers of donors who are permanently lost after wnv deferral are limited, the increasing numbers of lost donations make it important to consider alternatives to donor deferral such as wnv nat testing. background: low haemoglobin due to iron deficiency is increasingly recognized as a serious problem in many blood centers. donor education, iron supplementation, ferritin monitoring, and lengthening of inter-donation interval are currently the main mitigation measures. however, a number of factors in particular donor knowledge could impact their success. locally, iron supplementation programme was implemented since with target group of donors who have given blood within the last six months. aims: here we look at an online donor survey to gain insight on their view of the programme and knowledge. methods: donors with successful blood donation in the past six months would be given days of one tablet of iron supplementation ( mg elemental iron) since . an electronic questionnaire was sent to blood donors in to assess their view on the programme and knowledge which focused on iron store and absorption, compliance and any side effects occurred. results: donors (male to female was : . ) replied to the questionnaire. of them, received iron supplementation (male to female was : . ). most of the respondents ( %) had one or more donations in the preceding months. of the donors received iron tablets, only ( %) took all; ( %) took more than % but not all; ( %) took some but less than % and ( %) did not take any. gastrointestinal upset was reported in ( %) donors and constipation seen in ( %) among those who took at least some of the iron supplementation. most respondents answered correctly to the questions on the knowledge on iron store and absorption. when comparing those with better compliance (took more than %) to those who did not (took less than %), significantly more donors in the former knew vitamin c could enhance iron absorption (p < . ). on the other hand, no difference was seen when they were asked if ) iron can only be absorbed from meat; ) tea and coffee consumed during meal can enhance iron absorption; ) everyone can take iron supplementation on their own; and ) iron store in male is always more than female. summary/conclusions: the results suggested that there is definitely more room to enhance the blood donors' knowledge on iron store and absorption in order to improve the effectiveness of iron supplementation programme. besides, the side effects reported by the donors could be an important limiting factor that better alternatives should be explored and considered. background: vasovagal reactions (vvr) are a well-established deterrent to donor return. however, the correspondence between vvr experience and donor lapse is not perfect. in australia, for example, vvrs only reduce two-year return rates by % for whole blood donors and % for plasma donors. the elements of a vvr and the donor's interpretation of this event that protect against or encourage lapse have not yet been identified. aims: in this study we explored the views of donors on donating following a vvr, with a particular interest in their emotional reaction to the vvr, their understanding of what caused the reaction, and their intentions to return. methods: semi-structured telephone interviews were conducted with whole blood and plasma donors who had a recent vvr experience. data were analysed using the framework approach. results: donors are generally motivated to give blood to help others and to positively impact on those in their communities. they anticipate feeling good after their donation but in contrast, for many, a vvr leaves them feeling anxious, embarrassed, and disappointed. for donors, the experience of a vvr negatively influences their perceived ability to donate successfully, and many fear it will happen again. however, this effect appears minimised among donors who at least partially attributed their reaction to their own behaviour, such as poor hydration. for donors already juggling multiple demands, a vvr may tip the balance with donating becoming too much of an effort and perceived risk. however, donors appeared more confident to return if they felt supported by staff or if they could donate with family or friends. summary/conclusions: this study provides valuable insight into the vvr experience, which will aid in the improvement of donor safety and retention. the findings highlight the need to improve communication at the time of and following a vvr, to educate donors on how to reduce their vvr risk, and to intervene to help donors maintain their perceived ability to give blood in order to maximise retention following a vvr. background: frequent blood donation depletes the iron stores of blood donors. iron depletion might have negative effects on the health of the general population, but its effect on the blood donor population is not well known. aims: to investigate the iron status of finnish blood donor population and how it relates to donor health, the finnish red cross blood service set up the findonor , study in . we investigated whether there were changes in donors' selfrated health and if these possible changes could be associated with differences in iron biomarkers (ferritin and soluble transferrin receptor -stfr) or hemoglobin levels during the first study visit. methods: participants were recruited in three donation sites in the capital region of finland between may and december . participants filled out an electronic questionnaire about their health and lifestyle at the donation site during their enrollment visit. participants were asked by letter to fill out the same questionnaire electronically during the summer . we included the participants ( men and premenopausal and postmenopausal women) who completed both health questionnaires. to evaluate self-rated health we used the well-validated single question: "how would you rate your health in general?". participants were able to evaluate their health status on a five-point scale: excellent, very good, good, moderate, and poor. iron biomarkers and venous hemoglobin were measured from blood samples collected at the first study visit. we first computed the odds-ratios of reporting poorer health depending on demographic group. we then compared iron biomarker and hemoglobin levels between donors who reported improved, similar or poorer health rating. results: donors who rated their health in the first questionnaire as moderate (n = ), good (n = ), very good (n = ) or excellent (n = ) health tended to report improved ( %), similar ( %), similar ( %) or poorer ( %) health ratings respectively in the second questionnaire. pre-menopausal women reported their health poorer in the second questionnaire compared to the first questionnaire more often than post-menopausal women (pre-menopausal %, post-menopausal women %), or = . % ci . - . ). there were no differences between other groups. there were no significant differences in iron biomarkers levels (ferritin and stfr) or hemoglobin levels between donors whose health ratings were improved, similar or poorer. summary/conclusions: in this cohort, pre-menopausal women rated their health poorer at the end than at the beginning of the study more often than post-menopausal women. no association was found between changes in self-rated health and iron levels (ferritin, stfr) or hemoglobin levels. further studies about the factors relating to blood donors' self-rated health need to be carried out. background: in recent years, the blood donation business has made great achievements, but it still cannot avoid the occurrence of adverse reactions to blood donation which not only brings certain obstacles to the blood donation work, but also affects the enthusiasm of blood donors. aims: to understood the causes and other relevant factors of adverse reaction among blood donors, the information of blood donors at dai autonomous prefecture of xishuangbanna were analyzed in . methods: the data of volunteers from january to december were analyzed. the causes of adverse reactions were classified, and the incidence of adverse reactions was compared in terms of gender, frequency, age and blood type of blood donors. results: there were blood donors in , ( . %) of whom had adverse reactions and causes were induced, among which mental stress was the most common factor that accounted for . % ( cases). there was no significant difference in the incidence of adverse reactions between men and female (p > . ). from the frequency of blood donation, the incidence in the first donor was significantly higher than that in the second donor (p < . ). when it comes to age, the incidence was different and the - age group was the highest ( . %). among different blood group donations, there was no significant difference (p > . ). summary/conclusions: adverse reactions of blood donation is closely related to the psychological state and age of the blood donors. the staff of the blood center should further optimize the service, strengthen the communication and publicize the knowledge of blood donation. the ultimate goal is to increase the blood donation rate on the basis of reducing adverse reactions. background: blood loss due to repeated blood donation can lead to iron deficiency or anemia, but currently there is no management plan for the prevention of iron deficiency in korean blood donors. female and male donors are required to wait at least weeks between blood donations in korea, which is the shortest period among all northeast asian countries. female and male donors are allowed to donate whole blood up to five times per year and platelets up to times per year (if spaced more than days apart for the latter) due to the chronic blood supply shortage. these facts induce concern about the impact of blood donations on the donors' iron status. aims: this study aimed to evaluate the effect of oral iron supplementation in repeat donors based solely on donation history. methods: the high-risk group included male donors with ≥ whole blood donations or plasmapheresis or plateletpheresis donations, and female donors with ≥ whole blood donations or component donations, both within the previous year. the control group consisted of first-time or reactivated (ft-ra) donors who had no history of blood donation in the past years. the hemoglobin (hb) level, ferritin level, total iron binding capacity (tibc), transferrin saturation, and soluble transferrin receptor (stfr) of repeat donors at high risk for iron deficiency were compared to those of ft-ra donors. iron deficient erythropoiesis (ide) is defined as present if the log of the ratio of soluble transferrin receptor to ferritin was ≥ . . the repeat donors took iron supplements for weeks and the same tests were repeated after and weeks to evaluate their effects and the side effect and compliance was assessed. results: a total of male and female repeat donors were recruited, and each male and female ft-ra donors were recruited to the control group. after week iron supplementation, among male donors, the prevalence of: low hb level (< . g/dl) decreased from . % to . %; low ferritin level (< . ng/ml) decreased from . % to . %; high tibc level (> lg/dl) decreased from . % to . %; low transferrin saturation (< . %) decreased from . % to . %; and ide (stfr/ferritin ≥ . ) decreased from . % to . %. among female donors, the percentage of: low hb level (< . g/dl) decreased from . % to . %; low ferritin level (< . ng/ml) decreased from . % to . %; high tibc level (> lg/dl) decreased from . % to . %; low transferrin saturation level (< . %) decreased from . % to . %; and ide (stfr/ferritin ≥ . ) decreased from . % to . %. in total, male ( . %) and female ( . %) blood donors reported undesirable side effects related to iron supplementation. a total of male ( . %) and female ( . %) blood donors were administered iron supplementations for days. participants ( . %) answered that they were willing to take a complimentary iron supplementation. summary/conclusions: ferritin level, considered a reliable indicator of iron status, increased and ide decreased significantly after iron supplementation in female donor group, but not in male donor group, compared to the ferritin levels and ide of control donors. iron supplementation in repeat donors at a high risk of iron deficiency was shown to reduce their risk of iron deficiency or anemia irrespective of gender; however, -week oral iron supplement was not enough to restore iron storage level in the male donor group. background: c-reactive protein (crp) is an acute-phase protein and a non-specific maker of inflammation and tissue damage produced by the liver. several prospective epidemiologic studies have demonstrated that high-sensitivity c-reactive protein (hs-crp) is a predictor of future coronary events among apparently healthy men and women, hs-crp level greater than mg/l has been independently associated with a % excess risk in incident of coronary heart disease (chd) as compared with levels less than mg/l. frequent blood donation has been associated with a lower incidence of coronary artery disease (cad); however, there is a dearth of information on serum levels of crp in the nigerian donor population. aims: to investigate whether regular blood donation is associated with lower serum hs-crp level in nigerian blood donors. methods: a descriptive cross-sectional study carried out to measure serum levels of high sensitive c-reactive protein (hs-crp) and ferritin among blood donors attending the donors' clinic in lagos university teaching hospital (luth). subjects who did not meet criteria for blood donation were excluded. additional data on sociodemographic characteristics was collected using interviewer-administered questionnaire. serum ferritin was analysed using chemiluminescent microparticle immunoassay performed on the abbott architect ci (abbott laboratories, abbott park, il, usa). serum concentration of hscrp was estimated by immunoturbidimetry method using analytical kits from erba diagnostics mannheim gmbh in semi-autoanalyzer (xl , erba mannheim). data was analysed using stata version (stata corp) statistical software. results: in total of blood donors, ( . %) were males and ( . %) were females, the mean age was . ae . years. two hundred and thirty four ( . %) were first time donors and ( . %) were regular donors, serum levels of hs-crp was slightly higher in regular donors compared to first time donors ( . ae . vs . ae . mg/l, p = . ) though the difference was not significant. serum levels of ferritin was significantly higher in first time donors compared to regular donors ( . ae . vs . ae . ng/ml, p = . ). interestingly, levels of serum hs-crp were significantly higher in male than female population ( . ae . vs . ae . mg/l, p < . ) and smokers than non-smokers ( . ae . mg/l vs . ae . mg/l, p = . ). correlation analysis showed no correlation between serum hscrp and serum ferritin levels in both categories of donors while there was a weak positive correlation between hs-crp levels and white blood cells among the first time donors. summary/conclusions: this present study did not reveal any decrease in baseline levels of serum hs-crp with regular blood donation; smoking status and gender were however associated with an increase in baseline hscrp. this finding suggests that hs-crp level might not be a useful marker of future coronary events in healthy blood donors in nigeria. background: because the blood donation removes mg of iron from the donor, iron deficiency, frequently occurs in regular blood donors leading at a long term to the anemia. aims: to determine the effect of blood donations on ferritin levels in regular blood donors. methods: all prospective donors have been submitted to a physical examination and a health history assessment intended to ensure that the prospective donor is in a good general health and eligible to donate blood. the acceptance criteria are: • hemoglobin > or = . g/dl for male and > or = . g/dl for female • inter donation interval = days • donations/year for male and /year for female all eligible donors and deferred donors for all reasons except for low hemoglobin who accepted to enroll in this study and signed a consent. in addition to the medical exam, two samples have been collected one for cbc and another for ferritin. donation history, sex, age and weight have been documented. results: first time and regular donors accepted to enroll in this study. only female donors ( . %) participated to this study. . % of the participants were first time donor. % of male and % of female frequent donors are iron deficient out of male blood donors were iron deficient ( %) with serum ferritin < ng/ml. . % were repeat donors. out of female donors were iron deficient ( . %) with serum ferritin < ng/ ml, all were repeat donors. . % of repeat donors were iron deficient / of the deplete donors were first time donors summary/conclusions: frequent blood donors have higher prevalence of iron deficiency than first time donors. female donors have a slightly higher prevalence of iron deficiency than male donors. prevalence of iron deficiency in abu dhabi donor population is lower than the published data. changes need to be done on: increase inter donation interval or restrict the total number of allowable donations in a -month period for whole blood and red cells modifying donor hemoglobin requirements testing for serum ferritin iron supplementation donor education abstract withdrawn. background: haemovigilance procedures aim to guarantee not only the safety of the recipients of blood and its components but the safety of the donors as well. every adverse reaction that occurs during the donation of blood or its components can potentially be a threat to the health of the donor which can subsequently lead to the decision of the donor to resign from donating blood. aims: the aim is to analyse the type and the frequency of occurrence of adverse reactions among the donors donating blood or its components independently of the method of the donation. methods: we have analysed the number of collected donations and the number of adverse reactions in the years - in the group donors of aged - . we have specified following adverse reactions: vasovagal response without fainting, vasovagal response with fainting, vascular reactions (bruises) and other (e.g. allergic reaction to the anticoagulant, loss of blood pressure due to hypovolemia). the analysis was made using data obtained from computer system blood bank which is in operation in blood center in pozna n, poland. results: in years - the total number of adverse reactions among the donors was recorded which is . % of the total number of collected donations. % of the adverse reactions occurred in the group of donors aged - . vasovagal response without fainting was the most common adverse reaction in the total number of reactions and totalled . % of all adverse reactions. in the group of donors ages - it totalled % of all adverse reactions. the second most common type of adverse reactions was vasovagal syncope that totalled . %, in the analysed group of donors . %. vascular reactions (bruises) totalled . % of all adverse reaction, in the analysed group . %. the remaining adverse reactions totalled . %. summary/conclusions: . vasovagal reactions (with and without fainting) were proved to be most common adverse reactions in the group of donors aged - i.e. in the groups of donors just starting to donate blood. it seems reasonable to continue with further research into the reasons for the occurrence of this psychosomatic reactions. . it seems beneficial to provide constant educational activities of young donors regarding the preparation for the process of donation of blood and its components (proper nourishment, hydration as well as planning the time for scheduled donation long enough for a safe and pleasant procedure. . it seems beneficial to provide constant training for the medical staff involved in the process of donation regarding active observation of donors, proper conduct in the situation when the adverse reactions occur during the blood donation, ways to minimize the fear of donors, effective communication with the donors (explaining the process of blood donation, proper behaviour after the donation e.g. avoiding physical exercise or straining the arm). blood products -blood processing, storage and release background: the accumulation of microvesicles (mvs) in rbc concentrates during storage may be responsible for clinical symptoms such as inflammation, coagulation, and immunization. aims: our aims was to determine whether any of cd molecules responsible for important functions are present on the microvesicles, and if their expression level is dependent on the storage period of rbc units. additionally, by using cytometric analysis and phagocytosis visualization in a confocal microscope, we examined the interactions of donor monocytes with erythrocyte microvesicles, depending on their time of storage. methods: erythrocyte microvesicles were isolated from "fresh" ( nd day) and "old" ( nd day) stored rbc units. qualitative and quantitative cytometric analysis of these membrane structures was performed using the annexin v-fitc, anti-cd a-pe antibody, and calibrated beads. the microvesicles were also visualized under a confocal microscope. the expression of the molecules cd a, cd , cd , cd , cd , and of phosphatidylserine was analysed using flow cytometry. measurements of microvesicle phagocytosis by human monocytes were carried out using a flow cytometer and a confocal microscope. results: the analysis of the microvesicles with calibration beads allowed us to identify these structures with a diameter of about . lm in the "fresh" and "old" blood samples. we observed a statistically significant increase in the number of microvesicles in the "old" units ( ae mvs per ll), as compared to the microvesicles in the "fresh" ( ae mvs per ll). at day , the microvesicles had elevated expression levels of cd and reduced expression levels of phosphatidylserine. significant changes were also observed in the case of cd and cd molecules. the expression of these molecules of vesicles isolated from "fresh" rbcs was lower than in the case of -day vesicles. the phagocytosis index was significantly higher ( . %) for the microvesicles isolated from -day stored rbcs than for microvesicles from the - background: platelet concentrates (pcs) are conventionally stored at room temperature with a limited shelf-life of - days. alternative storage methods, such as cold storage and cryopreservation are attractive options due to the potential for extended storage, reduced bacterial growth and improved hemostatic function. cryopreservation of human pcs has been associated with formation of more microparticles and elevated procoagulant activity compared to liquid-stored (room temperature-and cold-stored) pcs. microparticles are submicron plasma membrane particles that have been postulated as potential mediators of adverse transfusion outcomes. similarities in the size and storage-related changes up to days suggest that sheep may be a suitable model in which to investigate the effects of pc transfusion. previous research has established that room temperature stored sheep pcs contain fewer microparticles than human pcs. however, nothing is known of the effect of other storage conditions. aims: this study aimed to determine whether cold storage and cryopreservation contribute to variation in concentration and size of sheep platelet derived microparticles compared to conventionally stored sheep pcs. methods: sheep buffy coat derived pcs in % plasma/ % ssp+ were prepared with minor modifications to standard procedures for preparation of human pcs. sheep pcs were split into units (n = of each) on day and stored either at room temperature (rt; - °c with agitation) for days, cold stored for days ( - °c no agitation) or cryopreserved (À °c with the addition of - % dimethyl sulfoxide) for - days and sampled post-thaw. platelet supernatant, prepared by double centrifugation, was stored at À °c. the mean size and concentration of microparticles were measured using nanosight ns nanoparticle tracking analysis system (malvern instrument). results are mean ae standard deviation. storage associated changes overtime were determined using a one-way analysis of variance with bonferroni's post-test. paired t-tests were applied to determine the effect of cryopreservation. a p-value of < . was considered significant. results: at day , sheep pcs had a microparticle concentration of . ae . microparticles/ml with a mean size of . ae . nm. storage duration at rt sheep pcs was not associated with significant changes to microparticle concentration or size. cryopreservation of sheep pcs significantly increased the concentration ( . ae . microparticles/ ml; p = . ) and the mean size ( . ae . nm; p = . ) of microparticles post-thaw. the mean size and concentration of microparticles in the cold-stored pcs at day was comparable to room temperature pcs stored for days ( . ae . nm vs. . ae . nm; p = . and . ae . microparticles/ml vs. . ae . microparticles/ml; p = . respectively). summary/conclusions: cold storage of sheep pcs did not impact formation of microparticles over the days storage period; however, cryopreservation increased microparticle concentration and the size post-thaw. further investigation is required to determine whether these findings are influence hemostatic function. a pre-clinical sheep model of cold-stored and cryopreserved pc transfusions can facilitate mechanistic studies and complement clinical trials. background: during storage, the properties of rbc in storage solution change ("storage lesion"). for instance, ph, atp and , -dpg concentrations decrease upon prolonged storage. these changes can affect oxygen delivery by the cells. the capacity to deliver oxygen is defined as p : the oxygen tension (po ) at which % of the hemoglobin is saturated with o . an oxygen dissociation curve (odc) represents the non-linear relationship between saturated hemoglobin and po . this relationship is dependent on temperature, ph, pco and , -dpg. due to changes in these factors, the curve will shift along the x-axis. in whole blood, p is at a po of about mm hg. not much is known about p of rbcs in storage solution, and the changes during storage. aims: to determine the oxygen dissociation of rbcs stored in standard red cell additive solution sagm and in pagggm (an experimental red cell additive solution, transfusion. ; : - ). methods: rbcs were prepared in sagm (n = ) or pagggm (n = ). pagggm is designed to better maintain both atp and , -dpg during storage. rbcs were stored at - °c and sampled on day , and for (internal) ph, atp, , -dpg and p . p was determined by hemox analyzer (tcs scientific corp.). the principle of the hemox is based on the measurement of spectrophotometric properties of hemoglobin at different oxygen pressure. rbc samples were brought from oxygen-rich environment to oxygen-poor environment ( %) using n gas. p was determined from the obtained odc. results: the whole storage period, ph i of pagggm-rbcs was higher compared to sagm-rbcs. , -dpg content of sagm-rbcs decreased during storage and was below the detection limit after day . , -dpg content of the pagggm-rbcs increased the first days of storage and slowly decreased from day on. at day , pagggm-rbcs still contained . -dpg ( . lmol/g hb). p values decreased during storage from mmhg at day to mmhg at day for sagm-rbc and from mmhg to mmhg for pagggm-rbc. p values of pagggm-rbcs were higher during the entire storage period. summary/conclusions: during storage, the p decreased in all rbcs. the p was higher for the pagggm-rbcs during the whole storage period. the higher p in pagggm-rbcs seems to correlate with the higher , -dpg content in these cells. background: in belgium % of the platelets are pathogen inactivated (pi) and legislation requires a minimum platelet content of . per platelet concentrates (pc). therefore routine pools are produced with buffy-coats (bc). facing increased demand of pc and stable to slightly declining red blood cells (rbc) demand, production of whole blood (wb) derived platelets must be adapted to switch flexibly from to bc per pool. this dual pooling strategy should allow alignment between wb collection forecast, pc inventory, pc demand and pc production. aims: first develop a pooling procedure with bc and ml platelets additive solution (pas) instead of ml for bc, without changing the settings of our wb separators and platelets separators. maintain a content of ≥ . platelets with a ratio plasma/pas between to % required for pi. after validation, deploy a dual pooling strategy ( or bc/pool). methods: wb is collected with top and bottom kit (composelect; fresenius kabi) and separated (macopress; macopharma) to produce ml bc with % haematocrit (htc) and > % platelets recovery with average platelets content of . random bc are pooled with ml or bc are pooled with ml of pas-e, platelets are then extracted on tacsi pl (terumo bct) and pc are treated for pi (intercept blood system; cerus). each pc is sampled and platelet content is determined (abx pentra xl ; horiba). results: during the study bc were processed into pools ( ( . %) with bc and ( . %) with bc). before tacsi separation, bc mixture with pas-e had volumes of ae ml ( bc) and ae ml ( bc) with respectively htc of ae % and ae %. the plasma/ pas ratio was ae % in both cases. tacsi separation was performed with one same program for both types of pools. after pi, platelets content of the pools was . ae . with bc and . ae . with bc (average ae standard deviation). pools below the limit of < . were / ( . %) with bc and / ( . %) with bc. the platelets concentrations ( /ll) were ae ( bc) and ae ( bc). platelets recovery was % ae for bc and % ae for bc. summary/conclusions: bc could theoretically produce pools of bc or pools of bc. this means a maximum potential gain of + % pc. in practice during shortage periods we switched from to bc when dictated by the actual inventory levels and hospital needs. the advantage of this dual pooling strategy was a gain in production capacity to cover these shortage periods ( pc, + %). the disadvantage of pooling randomly bc is that pools contained less than . platelets per pool potentially limiting their usage to low weight or paediatric patients. a preselection of the bc based on platelet count could optimize the bc pooling procedure. background: apheresis-derived platelet concentrates (apcs) is a standard medical therapy indispensable to contrast bleeding or hemorrhage. however, bacterial infection caused by storage at room temperature (rt) still remains the major drawback. recently, we showed that cold-stored apcs are associated with better plt functionality but with accelerated clearance (haematologica , pmid: ). cold-induced apoptosis was identified as a potential mechanism of the shorter plt survival aims: to investigate the protective effect of apoptotic inhibitors during cold storage of apcs methods: apcs were collected and stored at rt and °c in the presence or in the absence of caspase- inhibitor. the phosphatidylserine exposure and the mitochondrial membrane potential (mmp) (tetramethylrhodamine ethyl ester perchlorate [tmre ] staining) were measured using flow cytometry. the protein expression was quantified by western blot results: a higher expression of the apoptotic marker phosphatidylserine was detected in cold-stored apc compared to rt (% apoptotic events meanaesem: ae % vs. ae % p = . ). to verify if the apoptotic signal, observed with phosphatidylserine, specifically involved the intrinsic pathway, the mmp was analyzed as a marker of alive cells. interestingly, after cold storage a decrease of the mmp was observed compared to rt indicating the activation of the intrinsic pathway (mean fluorescence intensity tmre meanaesem: . ae . vs. . ae . , p = . ). accordingly, a decrease of the procaspase- level after cold storage was detected by western blot analysis. however, when plts were stored in the presence of caspase- inhibitor a significant rescue of the cold-stored cells viability was observed (tmre staining: % alive cells meanaesem: ae % vs. ae %, caspase inhibitor vs. ionomycin, p = . ). this indicates that the activation of the apoptotic pathway, induced during cold storage, can be prevented using caspase inhibitor summary/conclusions: our results show that the reduction of cold-stored plt viability can be prevented by a specific caspase inhibitor. consequently, cold storage, associated with a better plt functionality, may become an efficient strategy for apc storage in combination with apoptotic inhibitors background: gamma-irradiation is used to treat red blood cell (rbc) concentrates (rccs) for patients who are immunosuppressed. this treatment is known to damage rbcs and to increase storage lesions. one of the causes of the storage lesions is the presence of oxygen. several studies have shown, based on different strategies to reduce o , a reduction of storage lesions related to metabolism, protein modifications and cell morphology. aims: the present research work investigated the effect of gamma-irradiation on rccs stored under normal condition and hypoxia/hypocapnia. methods: saturation of o (so )-and abo-matched rccs from whole blood donations, leukoreduced and prepared in paggsm (macopharma, france) were pooled and split in two identical rccs within h post-donation. one bag (treated) was submitted to oxygen and carbon dioxide adsorption (oxygen reduction bag, hemanext, usa) for h on an orbital shaker ( rpm) at °cae and then transferred to a storage bag impermeable to gas. the other one (control) was left as it is. the two bags were then stored at °c. a g-irradiation treatment ( gy, gammacell elan, theratronics) was applied at day or and the rccs (expiry dates at day or day , respectively) were stored until day . hematological parameters, glycolytic metabolites, extracellular potassium level, antioxidant power, morphology and deformability were measured. results: starting so values were of . %ae . (n = ) in control and of . %ae . (n = ) in treated bags, and reached . %ae . and . %ae . at day , respectively. as expected, an increase in glycolysis rate was observed during deoxygenation without any influence from the irradiation. potassium levels were identical in treated and control, and reached around mm at expiry with an irradiation-dependent kinetic release. antioxidant power and deformability were identical in both conditions. no difference in hemolysis was observed after irradiation on day and the values stayed equivalent through end of storage (at day , hemolysis (control) = . %ae . , hemolysis (treated) = . %ae . , p-value > . ). when irradiated at day , hemolysis was lower (p-value = . ) in treated rccs at the end of storage (day , . %ae . ) compared to control ( . %ae . ). seven days post-irradiation, two-third of the control rccs were above the limit of . % whereas all the treated rccs remain below the limit. quantification of microvesicles and morphological analysis confirmed these data. summary/conclusions: the storage under hypoxia has a beneficial effect on rbc storage thanks to a decrease in o content and to an improvement of metabolism. this benefit provided equivalent storage when rccs were irradiated at day and was an advantage when irradiated at day . importantly, the results show that combining irradiation with hypoxia/hypocapnia retained the improved hemolysis profile of o depleted rbc. in summary, the reduction of o level in rccs enables a better storage of rcc when a late irradiation is applied. background: in vitro blood circuit machines require a constant monitoring of blood flow rate which have to be maintained at a constant value. also, measuring the hematocrit of flowing blood in such machines is essential for performing real-time diagnostics. recently, acoustophoresis has emerged has a promising blood separation technology capable of replacing centrifugation for the preparation of platelet concentrate. to avoid damaging blood cells, the technique is used without infusing pumps thus increasing the need of flow monitoring. however, acoustophoresis chips performs at low flow rates, outside the range of available commercial flow meters. in addition, hematocrit measurement is of a particular interest for acoustophoresis since it is a direct indicator of the separation efficiency. aims: in this study, we present a straightforward doppler ultrasound system designed for measuring blood flow rate and hematocrit in an acoustophoresis chip [bohec et al, platelets, ] . we show that the stability of the in vitro environment can be used to obtain high level of accuracy of the doppler method using a basic and low-cost experimental set-up. this improvement allows a precise measurement of flow rates as low as . ml/min in sub-millimeter tubing. furthermore we evaluate the capability of the system to measure hematocrit of human blood samples coming from different donors. methods: the experimental set-up was constituted of an ultrasonic continuous wave doppler probe mounted on a d printed support. the accuracy of flow rate measurements between . ml/min and . ml/min was evaluated as well as the optimal measurement time. for different blood bags, the relationship linking the total energy of doppler signals and hematocrit was derived. hematocrit in a range under % was estimated from doppler signals for each blood bag. results: the system is able to acquire exploitable doppler signals for the whole flow rate and hematocrit range. flow rate estimation from the signals shows a high accuracy with a mean measurement error under % for a measurement time of s. the mean error is still under % for a measurement time of . s. hematocrit estimation from doppler signals shows a good linear correlation with reference measurements for bags , and . hematocrit estimation for bag diverges from reference for values above %. summary/conclusions: the proposed doppler ultrasound system is capable of measuring low blood flow rate in narrow medical tubing with a high accuracy. it is particularly suited for an acoustophoresis device but the versatility of the system makes it easily applicable to any in vitro blood circuit. we furthermore demonstrated that the system can be used for measuring hematocrit under % without additional developments. this finds interesting applications in blood sorting technologies but also demonstrates that doppler ultrasound is a potential simple and low cost method for measuring hematocrit of flowing blood in vitro. background: hereditary hemochromatosis (hh) is the most common genetic disorder in populations of northern european descent manifesting with high levels of storage iron (ferritin) in blood and tissues. the standard treatment is serial therapeutic phlebotomy to decrease iron overload. the collected blood is frequently discarded but some blood banks allow "healthy" hh patients to donate blood for patient use. red cell concentrates from hh donors have been reported safe for transfusion, but little or no data is available on platelet concentrates from hh donors, including the potential contribution of surplus iron to the "platelet storage lesion". aims: the aim of this study was to compare platelet quality, activation and aggregation over seven-day storage in platelet-rich plasma from patients with newly diagnosed hh and from healthy controls. methods: whole blood ( ml) was drawn into compoflow blood bags containing cpd and sag-m from healthy controls and newly diagnosed hh patients. platelet-rich plasma (prp) was prepared from whole blood and split into four compo-flex bags each containing ml prp (range - platelets/l). platelet quality tests were performed on days , , , and of storage. platelet aggregation was tested using a chrono-log aggregometer and four agonists (adp, arachidonic acid, collagen, and epinephrine). platelet expression of cd , cd b, and cd p was measured with flow cytometry while ph and metabolites were measured with a blood gas analyzer. scd l and scd p in the supernatant were quantified using enzyme-linked immunosorbent assays. results: both hh and control groups included males and females. the mean age was significantly lower in the control group, years ( - years), than in the hh group, . years ( - years) (p = . ) while ferritin levels were significantly higher in hh patients (median . , range - ) than in controls (median . ng/ml, range . - ng/ml) (p < . ). in the hh group, each had the c y/c y and c y/h d genotypes. results of prp quality control tests were comparable between the two study groups over seven days of storage (p < . ) with the exception of glucose (higher in hh patients on all time points, p < . ). platelet aggregation and the expression of activation markers (cd p and cd b) on platelets and in the supernatant (scd p and cd l) were comparable between hh and control prp units over all seven days of storage. the analysis revealed comparable and expected alterations in metabolic and platelet activation markers over seven-day storage in both groups. ph increased, glucose decreased, and lactate increased over time while cd b expression decreased and cd p increased. platelet aggregation responses decreased during storage but to a varying degree depending on the agonist, however, the decrease was comparable in cases and controls. summary/conclusions: these results suggest that high iron stores in hh do not adversely affect the quality of platelet units produced from hh patients. furthermore, the data also suggest that blood from hh patients, including platelets, can be donated for patient use. background: platelets are often shipped over long distances from collection centres to blood processing centres and subsequently to hospitals. platelet agitation facilitates oxygen transfer, thus promoting aerobic metabolism, and maintaining platelet ph. during shipment, platelets cannot be agitated continuously, which may promote anaerobic metabolism. previous studies have examined the effects of prolonged periods without agitation on apheresis platelets collected in plasma, but not platelets in platelet additive solution (pas). it is therefore important to determine whether platelet quality and function are maintained during prolonged transport or hold time in a shipper. aims: the aim of this study was to evaluate the effects of prolonged storage without agitation on the in vitro quality of apheresis platelets in pas. methods: triple dose apheresis platelets (n = ) were collected using a trima accel platform in % plasma/ % pas (ssp+). after resting for h, platelets were split equally into three components, packed into a shipper and transported immediately to the blood centre. upon arrival, one of the platelet components was removed (< h; t ), and the others remained within the shipper, without agitation. the second component was removed at h post-collection (t ), and the third was removed at . h post-collection (rounded up to h; t ). platelets were tested on day , and post-collection and in vitro quality and function were monitored. data were analysed using a two-way repeated measures anova, where a p-value of < . was considered significant. results: platelets held without agitation for h consumed significantly more glucose than those removed at h or immediately upon arrival (p < . ), even on day post-collection. this was accompanied by increased lactate production (p < . ), indicating increased anaerobic glycolysis. consequently, the ph was significantly lower in t platelets (p < . ), and on average it was . ph units lower than in platelets held in the shipper for h or less. however, the ph remained above . in all components. mean platelet volume was also reduced in t platelets (p < . ), suggesting acceleration of the platelet storage lesion. phosphatidylserine exposure, surface expression of cd p and microparticle generation were significantly higher in the t platelets throughout the storage period (all p < . ), suggesting platelet activation. release of scd p was also increased in t platelets (p = . ), whereas extended storage in a shipper did not affect release of rantes (p = . ). adp-induced activation of glycoprotein iib/iiia, measured by pac- binding, was decreased in t platelets (p < . ), indicating reduced platelet responsiveness to agonist stimulation. additionally aggregation in response to collagen (p = . ) and adp (p = . ) were significantly lower in t platelets, suggesting a decrement in platelet function after prolonged storage without agitation. summary/conclusions: significant in vitro changes were observed in platelets held without agitation for h. these results suggest that the length of time that platelets are held in a shipper should be minimised where possible. background: the shelf-life for platelet products has been restricted to days. this very limited window of time is intended to sustain the quality of platelet and to reduce the risk of bacterial growth. we have recently demonstrated that in suitable platelet bags, the platelet product quality remains high after days of storage. this was proved by examining in vitro, the quality parameters of platelets such as platelet concentration, glucose, ldh, and ph (alexopoulos k. et al., haema, , ) . our new target is to extend this research in extra days of storage. we also want to determine if there is any bacterial development in this period. aims: the goal is to investigate the capability of storage period for platelet units, from to days. methods: in this study, platelets were collected from normal blood donors in the blood bank department of general hospital of patras "agios andreas". a total of ae ml of whole blood was drawn into triple cpd/sag-m top-top bags blood container systems, lmb technologie (gmbh). the platelet concentrates were prepared by platelet rich plasma (prp) method and then they were placed in a platelet incubator with agitator (helmer pc ). samples were drawn aseptically with a needless access coupler (cair-lgl) on days , , and . platelet count was done by ceeldyn ruby (abbott all data shown are reported as mean ae standard deviation (sd). the swirling effect remained positive (+) during the seven days storage period. the bacterial screening was found negative. summary/conclusions: platelet concentration in the bag remained constant between day and day , maintaining platelet yield. the decrease in glucose and increase in lactate, along with the decreased ph, show that the platelets remain metabolically active between days and of storage. the ph remained well within the acceptable range. no bacterial contamination was reported. thus, we conclude that platelet concentrates in these specific bags may be used with an extended shelf life of days. further studies are needed with other platelet bags to confirm our hypothesis. abstract withdrawn. aims: we introduce rt-dc as a fast, robust and unbiased quality control tool for pc, rcc and hpsc. utilizing the interdependency between cell deformation and the molecular state of the cytoskeleton, we demonstrate that rt-dc is capable to assess the quality of blood products. methods: by rt-dc we assessed: i) platelets after storage at °c or room temperature (rt) over days for apheresis pcs in addition to standard in vitro platelet function assays; ii). red blood cells before and after gamma irradiation in addition to hemolysis; and iii) hpsc after cryopreservation with % or % dmso in addition to cell count, and in vitro viability. in addition we compared the regeneration time of patients' platelets and leukocytes after transplantation of hpsc products containing either % or % dmso. results: for pcs standard quality assurance tests did not show a major difference between °c and room temperature storage while rt-dc showed a highly significant difference between both start conditions (day - , p < . and day , p < . ). for red cells, we found by rt-dc no impact of gamma irradiation with gy over the entire storage period of days assessing different rcc. for hpsc, rt-dc showed that cryopreservation in liquid nitrogen resulted in a significant increase in deformation ( . for % dmso versus . for the control without dmso; p < . ). however, this did not differ to high extent whether % or % dmso were used for cryopreservation ( . and . , respectively; p < . ). hpsc viability was lower after cryopreservation using % dmso in comparison to using % dmso. overall, blood cell regeneration is comparable between % and % dmso. summary/conclusions: studying platelet and red blood cell concentrates as well as hematopoietic stem cells under different, clinically relevant, storage conditions our results demonstrate that intrinsic material properties reveal insights into cell function and allow to predict cellular state in a robust way and using small sample volumes. in order to offer more flexibility to the production process, the storage of bcs overnight ( h) has been validated in our blood center. aims: the aim of the study was to assess the platelet quality in platelet concentrates derived from overnight stored buffy coats. methods: whole blood collected at day was separated into plasma, bc and red cell concentrates either at day or at day . bcs were then stored until the pooling step at °c without agitation and pcs were prepared at day by pooling isogroup bcs. seven " h-pcs" were prepared from bcs stored for h (whole blood separation at day ) and six " min-pcs" from bcs stored for min (whole blood separation at day ). standard quality control measurements were performed during the process and the storage. in addition, the quality of the platelets into the prepared pcs was assessed throughout the period of storage by measuring the hypotonic shock response (hsr) and by measuring by flow cytometry the proportions of platelets in apoptosis (marked with annexin v), of functional platelets (marked with cd ) and of activated platelets (marked with cd the changes observed during the -h storage period appear to be limited and compatible with a further pr process using a photochemical treatment (amotosalen and uva) with intercept. summary/conclusions: leukocyte-depleted "double dose" buffy coat platelets with a high platelet content and ready for pathogen reduction can be obtained with the ipp pooling and leukodepletion set developed by kansuk. a storage period of h before applying the photochemical treatment is feasible without significantly altering the biological quality of platelets. methods: dd-bc-pc were prepared with bc and ml of pas (intersol, fresenius kabi (germany) are sterile docked to the octopus harness and combined into a ml pooling bag. the pool is centrifuged and the pc supernatant expressed through a bioflex cs leukodepletion filter into a temporary platelet storage container. the obtained dd-bc-pc were tested within h of preparation and after storage for h in the platelet storage container for volume, platelet content, residual leukocytes (wbc), plasma ratio and biological parameters, ph, po , pco , glucose, lactate, mpv, ldh, p-selectin and swirling. results: the platelet content of dd-bc-pc (n = ) was on average . ae . . in a volume of ae ml. the mean of plasma ratio was % [min: . max: . ]. all pc contain < . wbc [min: . g/ dl). red blood cells (rbcs) of b-thal-het donors are characterized, in vivo, by particular geometry and redox status. despite sporadic indications that the rbc storage lesion may be milder in b-thal-het, targeted research on this donor group is still missing. aims: the aim of this study was to investigate whether b-thal-het rbcs storage at blood banks leads to a distinctive hemolytic, physiological and redox profile, thus, making b-thal-het a unique blood donor group. methods: blood samples from healthy non-smoker donors ( b-thal-het carriers and controls) were analyzed before and after preparation and storage of leukoreduced packed rbc units in cpd/sagm at various time intervals. susceptibility in hemolysis (in the presence/absence of oxidative, mechanic and osmotic stimuli), redox status (lipid peroxidation, reactive oxygen species (ros) accumulation, antioxidant capacity), intracellular ca + and proteasomal activities were determined. for statistical analysis, significance was accepted at p < . . samples from the red cell units were collected aseptically, processed (dual centrifugation at , g for min) and stored at À °c. processed samples were thawed, and then analysed using the nanosight ns nanoparticle tracking analysis system (malvern instruments). samples from all time-points from each unit were analysed on the same day. data were analysed by one-way anova with bonferroni's multiple comparisons test. results: at d , red cell units contained an average of . ae . mvs/ ml. the mean size of these mvs was . ae . nm and the mode size was . ae . nm. the concentration of mvs increased gradually throughout storage (p = . ), reaching a maximum at d of . ae . mvs/ml. both the mean (p < . ) and mode (p < . ) size of the mvs increased during storage; however, this size increase primarily occurred in the first week of storage (d vs. d : p < . for both mean and mode). by d , mean and mode size of mvs was . ae . nm and . ae . nm summary/conclusions: nanoparticle tracking analysis demonstrated the presence of mvs smaller than nm in red cell units. both the concentration and size of mvs present in red cell units increased during the days of routine storage. the concentration of these mvs was approximately -fold higher than we had previously detected using flow cytometry (aung, pathology, ) indicating the advantages of more sensitive techniques in characterisation of mvs. background: the lack of availability of sterile saline in a format suitable for use in blood centers for manual washing has led to an urgent need for blood services to consider alternative methods. for operational flexibility it would be desirable to be able to produce a washed rbc unit that had a shelf life longer than h. aims: the aim of this study was to validate the manual method for washing rbcs using sagm solution both as wash and storage solution and to ascertain whether an extended storage period for washed rbcs may be feasible. methods: six day old leukocyte depleted red blood cells (ld-rbc) and six day old ld-rbcs were manually washed and stored in sagm, and half of the units were pre-stored irradiated ( gy). a volume of ml wash solution (sagm) was added to the ld-rbss by sterile connection. after mixing the units were centrifuged for . min at g at °c (hettich roto silenta rs) before removing the supernatant using compomat g extractor. wash procedure was repeated twice using ml sagm solution, and after removal of the last supernatant, ml of sagm solution was added. all units were immediately measured for volume, haematocrit, albumin, iga, potassium, haemolysis, haemoglobin, ph, glucose and lactate and tested again after h, days and days storage at ae °c. results: all washed ld-rbcs met european specification for haematocrit ( . - . ) and all but one for hb content (≥ g/unit). hemolysis increased during storage. the rate of hemolysis in irradiated ld-rbcs was greater over time than in nonirradiated units. all units, both irradiated and nonirradiated, met european specification for hemolysis (less than . %) days after washing. after wash, potassium levels were low and then increased during storage; increase was greater in irradiated than nonirradiated units. potassium concentration days after washing and irradiation did not exceed those levels found at the end of shelf life (day ) of standard ld-rbcs. ph decreased during storage due to the metabolic activity of red blood cells converting glucose to lactate. the ph level of the supernatant depends on the age of the unit and not on the irradiation. the glucose concentration of the supernatant after washing is high due to sagm solution. the concentration of glucose decreased and lactate increased due to the metabolic activity of red blood cells. there is currently no specification in europe or finland for iga in washed rbcs. aabb and american red cross rare donor program stipulate that level of iga should be less than . mg/dl ( . mg/l). our iga method s lower limit for detection is . mg/l and all results were below this level. total albumin were well below finnish specification (< mg/unit). background: room temperature has been the standard storage condition for platelets since the s, when it was shown that this improved in vivo survival compared to when stored at °c. however, storage at room temperature has several disadvantages, including risk for bacterial contamination and short outdating. recently, the interest in cold-stored platelets increased, especially for patients with a hemostatic need. using extensive analysis techniques, we evaluated the in vitro quality of cold stored platelets in additive solution. aims: investigation of the in vitro quality of platelets stored at - °c in pas-e. methods: three experiments were performed, in which two platelet concentrates, prepared from buffy coats and ml of pas-e (pcs) were pooled and split in equal pcs. pcs were stored for days at - °c, one of each pair with agitation on a flatbed shaker and the other without agitation. various parameters were analyzed to study the in vitro quality during storage and compared to routine room temperature storage. results: during cold storage, the swirling phenomenon disappeared within one day. due to the lower temperature, metabolism of the platelets was lower as compared to room temperature storage. the metabolic conditions were acceptable with ph d -d : . - . with platelet count /u and glucose still at mm at least until days of storage. platelet activation maintained acceptable levels with cd p expression < %, while ps exposure increased rapidly; > % after days of storage. aggregation tests showed functional platelets until days of storage. agitation during storage had no effect on any of the tested parameters. summary/conclusions: during storage of platelets at - °c, the hematological parameters and ph met routine requirements, while swirling phenomenon disappeared already at the first day. the functionality of the platelets did not decrease during cold storage, indicating that the swirling phenomenon is not a good surrogate marker under these conditions. the strong increase of ps exposure might be involved in the observed short survival of cold-stored platelets. platelet concentrates stored at - °c are potentially suitable as a hemostatic agent for patients with a bleeding in need of platelets, but more studies are needed. aims: the goal of the study is the reinforcement of platelet reserves for case of emergency events and increasing their availability for treatment, preferentially in patients with massive bleeding. methods: we performed a comparative study with cpp and fp in vitro. buffy coatderived pooled leukoreduced platelets rhd negative were frozen in - % dmso and stored at À °c for months. cpp were thawed at °c, then reconstituted in platelet additive solution ssp+ and compared to fp. we measured these parameters: platelet content, platelet concentration, platelet loss during preparation process, coagulation properties, volume, ph, dmso concentration, titres of anti-a and anti-b antibodies. results: the average platelet loss after the process of freezing and reconstitution was %. the amount of platelets and platelet concentration in unit was lower in cpp compared to fp, but high enough (amount /unit, concentration . /unit). both types of plts (either pcc or fp) maintained an acceptable ph during storage. swirl was on value in fp and on value in cpp. the average plasma content in fp was % compare to . % in cpp after reconstitution. measured titres of igm anti-a and anti-b antibodies were very low ( - : ). cpp had faster clot initiation (rotem clotting time (ct) in cpp . s, fp . s). cpp contributes to a sufficient clot (rotem maximum clot firmness (mcf) in cpp . mm, fp . mm). summary/conclusions: our results shows, that cpp have higher procoagulation activity and simultaneously lower clot firmness. thawing and reconstitution of platelets are easy and fast processes if platelet additive solution is used. this method helps to increase the availability of platelets in emergency medicine. low plasma content in cpp enables their use as washed platelet product in specific groups of patients. methods: after donation, the whole blood was stored in room temperature overnight before separating next morning by reveos â system. seven abo compatible ipus, each with a target volume of ml, were selected and then they were connected to the pooling set provided by terumo bct. prior to the pooling of ipus, ml of additive solution (t-pas+ provided by terumo bct) was added and distributed evenly between the ipu bags. the pooling set was then kept h on bench in room temperature followed by h on agitator at ae °c. after filtration, the pool might be manually adjusted if its volume exceeded the maximum of ml to meet the requirements by the intercept tm blood system. the final products were two pathogen-reduced platelet units with a shelf life of days. results: during validation of the method, pathogen-reduced platelet units were controlled, in addition to the platelet count, for ph, glucose, po , pco and lactate on day , and of storage. the platelet count was . ae per unit on day . the ph value was . on day , . on day , and . on day . the glucose concentration decreased from . to . and . mmol/l on day , and , respectively. the mean po level was . , . and . kpa while the mean pco was . , . and . kpa and the lactate concentration was . , . and . mmol/l on day , and , respectively. since routine implementation of the method in april , regular quality controls showed an average of platelet count of . ae (n = ) with a volume of ae ml per unit. summary/conclusions: the validation of the method and the following two years of experience in routine shows that the pooling of ipus processed in reveos â system meet the requirements needed for intercept tm ds processing set for pathogen reduction of platelets. the results from the quality controls of the final platelet units were in accordance with the local and eu guidelines. methods: data was analyzed from published and unpublished clinical studies that performed both primary and secondary testing of platelets using the bta system. the studies included apheresis and whole blood derived buffy coat platelets and tested - ml sample volume per culture bottle. the studies classified results based on aabb bulletin - definitions with some modifications. the following assumptions were made including: • data was summarized as total number of positive tests, observed by the total number of tests performed on each day post collection; • it was assumed that one test was performed per platelet unit; • all units eligible for secondary testing were negative by the primary test the data needed to demonstrate a benefit for the use of the bta d systems for detecting contamination that was not revealed by previous bacterial testing as well as clinical specificity. results: a total of , platelet units from the studies where secondary testing of platelets was performed were analyzed. platelets were tested on day , , or ≥ , and represented . %, %, and % of the units tested, respectively. true positives were detected in platelet units representing . % of the total platelets tested. the majority were reported from platelets tested on day ≥ with a total of . data showed the bta d system used for secondary testing detects the most prevalent contaminates reported, staphylococcus spp., in ≤ h with the majority detected in ≤ h after incubation, allowing for interdiction of the units prior to transfusion. instrument specificity was reported in of the studies for platelets tested at days and ≥ days with a total false positive rate of . % (range of - . %). instrument sensitivity when used for secondary testing could not be determined since subculture of negative bottles is not performed during routine use. during previous validation testing of lrap and lrwbpc, , culture bottles were confirmed true negatives by subculture. summary/conclusions: data from the studies that tested platelets at to days post collection provided evidence that the bta d with bpa & bpn detects contaminants missed in previously tested platelet units. the data supports that the bact/alert d system is an effective safety measure for secondary testing of platelet products to extend platelet dating beyond day and up to day when testing is performed using the test parameters described in the bpa and bpn bottle ifus and according to the fda draft guidance. background: magnetic nanoparticles have recently shown great potential in nonradioactive labeling of platelets. platelet labeling efficiency is enhanced when particles are conjugated with proteins like human serum albumin (hsa). however, the optimal hsa density coated on particles and the uptake mechanism of single particles in platelets remain unclear. aims: we characterize the interaction between single particles and platelets and determine the optimal hsa amount required to coat particles. methods: ferucarbotran iron oxide nanoparticles were coated with hsa in different amounts ( . - mg/ml) and we confirmed successful hsa coating by addition of a crosslinking hsa antibody (dynamic light scattering). we labeled platelets from pooled platelet concentrates with mm ferucarbotran coated nanoparticles and analyzed labeled platelets for iron content (atomic absorption spectroscopy) and particle localization (transmission electron microscopy). single-molecule force spectroscopy was used to determine binding forces of nanoparticles to platelet compartments. we applied hsa-particles via linkers of different length (i.e. short~ nm, medium nm and long~ nm) on the cantilever tip and let them interact with a platelet provided on a collagen surface. after interaction we determined the rupture force required for platelet retrieval. results: the iron content per platelet reached a maximum at . - . mg/ml hsa coated particles with . ae . and . ae . pg/platelet, respectively. however, the . mg/ml hsa coating resulted in~ -fold higher binding affinity to platelets than particles coated with . mg/ml hsa. depending on peg length between tip and particle, particles interacted differently with platelets as shown by one, two or three force distributions of , , and pn, which correspond up to three different binding pathways, respectively. the results indicate that a particle can interact with three targets including platelet membrane, open canalicular system, and platelet granules. summary/conclusions: our results reveal mechanism of platelet-particle interaction on a single particle level and provide an optimal hsa concentration coated on particles to gain maximal platelet labeling efficiency. labelling of platelets by magnetic nanoparticles may substitute radioactive labeling. results: the activation/lesions on total platelets and small and medium-sized platelets platelet population was detected on storage day , by the increased expression of cd . the percentage of cd -positive cells among the population of large platelets did not change during storage. on the day , increased expression of cd b and cd p was detected, but only on large platelets. small and medium-sized platelets had increased cd p expression only on day . the expression of cd a on total platelets increased significantly on day , and stayed unchanged until day . the same pattern of cd a expression was detected for small and medium-sized platelets, whereas on large platelets the expression continued to increase until the end of storage. a decreased percentage of cd -positive cells was detected among the total platelets and populations of medium-sized and large platelets. the storage induced externalization of phosphatidylserine on total platelets or on any of the platelet populations was not detected. the levels of tgf-b and p-selectin in the pc-bc supernatants were unchanged during the -day storage period. increased annexin and pf concentrations were detected on day . the concentration of b-tg increased on day of storage, and continued to rise until the end of storage. summary/conclusions: the evaluation of expression of activation markers on different platelet populations could be used as an additional analysis in quality control of platelet concentrates, and in the assessment of novel approaches to platelet concentrate manipulation i.e. for testing new additive solutions, cryoconservation protocols, and cryoprotectants. background: the primary goal of autologous blood transfusion is to reduce the risks related to allogeneic blood transfusion, including transfusion-associated graft-versus-host disease (ta-gvhd). although downward trends in rates of autologous blood transfusion have been reported in europe and the americas, it still plays a role in eliminating risks related to allogeneic blood transfusion in japan, especially ta-gvhd. since february , the transfusion service in our hospital has managed autologous blood conservation techniques and helped to prevent mistransfusion by employing a bar code-based electronic identification system. aims: the objective of this study was to determine the use of types of autologous blood components in a single institution over an approximately -year period. methods: between february and december , we retrospectively analyzed autologous blood transfusion, including perioperative autologous cell salvage (pacs), pre-operative autologous blood donation (pad), and acute normovolemic hemodilution (anh). we investigated the use of autologous blood components and the rate of complying with electronic pre-transfusion check at the bedside in the operating rooms. we also determined the adverse reactions to autologous blood transfusion, which were categorized according to the definitions proposed by the international society of blood transfusion (isbt) working party on haemovigilance. results: a total of , patients ( % of whom received operations) received blood transfusion, of which , ( %) received autologous blood transfusion alone, , ( %) both autologous and allogeneic blood transfusions, and , ( %) allogeneic blood transfusion alone. the rate of autologous blood transfusion among patients who received blood transfusion was %. pacs units were transfused to , patients ( %), pad units to , patients ( %), and anh units to patients ( %), and multiple blood conservation techniques were used for one patient. the overall compliance rate with electronic pre-transfusion check at the bedside in autologous blood components was . %. adverse reactions were observed only with pad transfusion and not pacs nor anh. the number and rate of adverse reactions to pad transfusion were and . %, respectively, of which the most common was febrile non-hemolytic transfusion reaction at ( %), followed by allergic reactions at ( %), and hypotensive transfusion reaction at ( %). the severity of adverse reactions to pad transfusion was grade (non-severe) in all cases, and no serious adverse reactions were observed. among pad units, the rate of adverse reactions to whole blood pad units was . %, that to frozen pad units was . %, and that to autologous ffp units was . %. summary/conclusions: our observations indicate that the rate of autologous blood transfusion among patients who received blood transfusion was %, when all types of autologous blood conservation techniques were included. to accurately determine the rate of autologous blood transfusion in a hospital, it may be better for the transfusion service to manage all types of autologous blood conservation techniques. they are now clinically available as a blood product. the residual plasma level of this product, which is prepared using the automated cell processor acp (haemonetics corp.), is approximately %. recently, a retrospective multicenter study was reported that this product was effective and safety for prevention of recurrent or severe transfusion reactions. plt products are generally stored with continuous agitation to maintain their quality. the interrupted agitation of plt suspended in additive solution (plasma carryover: - %) for up to h was previously found to have only a slight impact on in vitro plt properties. however, in some small hospitals with no agitator, if the initiation of transfusion is delayed by an emergent change in a patient's condition, the interruption of agitation may be prolonged. aims: the aim of this study was to evaluate the effects the interruption of agitation for h (shelf life of wpc in japan) on the in vitro qualities of plt. methods: leukoreduced apheresis platelet concentrates in % plasma were washed on day one after blood collection using the automated closed-system cell processor acp (n = ). wpc, which were rested h after preparing, were divided equally into control and test units using polyolefin containers on day one. control units were agitated from days one to seven. test units were stored without agitation from days one to three, and agitation was subsequently performed until day seven. both units were stored at - °c. in vitro plt quality was examined on days one, three, four and seven. results: the plt concentration of prepared wpc was . ae . ( /l) and the volumes of the control and test units after the division were ae and ae (ml). the ph values of the test units on day three were lower than those of the control units; however, the ph of both units were maintained at higher than . during the seven-day storage period. swirling was well maintained and no clumping was visible in both units during storage period. no significant differences were observed in plts concentrates, mpv, hsr, aggregation response. the pco , po , bicarbonate, glucose and lactate mean values of test units were slightly lower or higher than those of the control units on days three or four. the levels of cd p expression were significantly higher in the test units than in the control units on days three ( . % ae . vs . ae . , p < . ); however, this difference decreased in a time-dependent manner after agitation resumed. the levels of cd b expression of test units were relatively lower than those of the control units until day seven, but no significant difference between the two units. background: monitoring residual white blood cells (rwbcs) is a requirement for quality monitoring (qm) the production of leucocyte depleted blood components. although flow cytometry is widely used for monitoring rwbc, there are no widely accepted methods to accurately and consistently measure rrbcs in blood components. sysmex have developed a novel algorithm, termed the blood bank (bb) mode for their xn-series of haematology analysers which is specifically designed to quantitate the levels of rwbcs and rrbcs in blood components. aims: we have previously assessed the linearity, accuracy and reproducibility of the bb mode on spiked samples in an r+d lab. we sought to further assess the performance of the bb software in a routine, high throughput blood component manufacturing department. methods: units of plasma, platelets (pcs) and red cell concentrates (rccs) were produced according to standard uk specifications within nhs blood and transplant (nhsbt). qm of residual cells was tested using the bb mode whilst rwbc was additionally analysed by flow cytometry using bd leucocount kit. results: during a -month field trial over , data points were collected representing all types of manufactured component. for some pcs, bb mode results from some sample tubes that did not contain edta gave very high rwbc values, indicating a potential large number of ld failures. the results were significantly different from those obtained from pcs using edta samples (p < . ) which did not show the same high values. for rccs or plasma, the range of results from plain and edta tubes were not significantly different (p ≥ . ). the analyses of ld platelet and plasma concentrates by either bb mode or flow cytometry both show more than > % of ld components have less than rwbc/unit. for ld failures (n = ) there was a good correlation (r = . ) between flow cytometry and bb mode measurements. spiking studies suggested that the limits of detection and quantitation of rrbc were around and rrbc/ll respectively. residual red cell counts from manufactured components showed a wide variation in their numbers between units. as expected platelet production methods also showed a significant difference (p < . ) in rrbc contamination, with lower levels in apheresis platelets (median = rbc/ll, n = ) compared to those produced from buffy coats (median = rbc/ll, n = ) in our hands, although the time taken to analyse samples is similar for flow cytometry and bb mode, considerable time can be saved on manual handling and the processing of samples for flow cytometry (approximately - h for - samples). summary/conclusions: we have been able to embed the sysmex bb mode into a routine production environment and confirm that its performance in spiked samples is mirrored in routine use. for platelets, sample collection in edta is essential. the bb mode offers an opportunity to reduce operator time compared to flow cytometry whilst gaining additional information on rrbc. abstract withdrawn. results: in our experiment, the typical size of a spectrin matrix section (l) was to nm (without oxidation). the heights (h) of dips were to nm. due to oxidation, the junctional complexes between spectrin and membrane proteins can rupture. only % to % of the spectrin surface has the same structure as in the control group. the values of l and h vary significantly depending on the intensity and time of exposure. we observed significant changes in the spectrin matrix after exposure to uv radiation in a model experiment. the local topological defects in the membrane arise from the action of oxidizing agents on the red blood cells. the mechanism of their appearance is connected mainly with the distortion of the spectrin matrix. as a result of oxidation processes, the spectrin molecules can be damaged. there is a transformation of tetramers to dimers. additionally, it can be easily seen with the afm, that spectrin network structure was essentially destroyed. most parts of the spectrin matrix have damaged structures with mesh breaks and dips after uv irradiation. also the results of network distortions in response to temperature changes were obtained. there are presented preliminary results of spectrin matrix change during long-term storage of prbc. summary/conclusions: atomic force microscopy in direct biophysics experiment allows to observe and to quantitatively measure the disturbances in the spectrin matrix nanostructure in response to oxidation processes in rbcs. these studies are important for the fundamental research of interactions of rbcs on the molecular level during redox processes and the consequences to their structure and function on the cellular level. this is important for the advancement of transfusion medicine, intensive care medicine, and molecular and radiation biology. methods: blood samples were taken from donors during a prophylactic examination and collected with edta-filled microvettes (sarstedt ag and co., germany). all experiments were carried out in accordance with the institute guidelines and regulations. the polylysine-coated glass was used to perform the sedimentation method for formation of native rbc smears. it is important that any fixatives weren't used. the stiffness of rbc membranes was studied in native rbcs (control) and native cells after the application of modifiers: glutaraldehyde, hemin, zn + (heavy metal ions). local stiffness was studied by atomic force spectroscopy (afs) (ntegra prima, (nt-mdt, russian federation). results: experimental kinetic curves i(z) were measured. nonlinear fitting method was used to determine the young's modulus. the experimental dependences of membrane bending were approximated by the hertz model to a depth up to nm. the young's modulus e = ae kpa for control rbc. it was shown that some natural oxidants (hemin), membrane fixatives (glutaraldehyde) modifiers, heavy metal ions (zn + ) significantly increased the absolute value of the young's modulus of rbc membranes up - times. the biophysical parameter hertz depth (h hz ) was determined for each curve. under the influence of modifiers the hertz depth h hz was changed from nm to nm. there are presented preliminary results during long-term storage of blood. summary/conclusions: the blood rheology is determined by rbc deformability, associated with membrane stiffness. the young's modulus can be used as a quantitative criterion to estimate the membrane state of a native cell. the results of the work can be used in clinical practice, in assessment of the quality of donor blood during storage before transfusion, in biophysical studies of rbc state. abstract withdrawn. immunohemotherapy, centro hospitalar universit ario são joão, epe, porto, portugal background: transfusion of blood and blood components is an essential resource in modern medicine. a proper use of human blood, being an irreplaceable resource, is necessary in order to achieve minimal wastage. blood wastage may occur for a number of reasons, like expiry date, haemolysis, seroreactivity or low volume. monitoring wastage of blood product during collection, testing and processing of blood is used as a quality indicator. aims: to determine the annual rate of discarded blood components due to expiry date in a portuguese university hospital blood bank (bb) from january to december , in order to implement appropriate measures to minimize the number of discarded blood to a reasonable rate. methods: we retrospectively analysed the rates of blood components discarded after meeting their expiry date of a portuguese university hospital blood bank from january st to december st . results: a total of , whole blood units and , apheresis platelets were collected during the study period. of the , blood components (packed red cells, whole blood pooled platelets and apheresis platelets) prepared during the study period, a total of , ( . %) blood components were discarded, of those . % due to expiry date. the rate of discarded packed red cells, according to this component production, decreased considerably over the years, in was . %, in was . % and . % in . similar tendency was shown in the pooled platelets for consecutive years with . % ( ) and . % ( ), but with an increase in ( . %). the rate of apheresis platelets had a more variable behaviour from to with rates of . %, . %, and . % respectively. summary/conclusions: blood transfusion is an essential part of patient care. for this reason, the implementation of a quality system and continuous evaluation of all activities of the bb can help to achieve maximum quantity and quality of safe blood. we identified that date expiry was the main reason of discarded blood components, although there was a significant decrease in the rate of discarded packed red cells over these three years. properly implemented blood transfusion policies, donor screening and training staff as well as implementation of automation also helps to improve the process, reducing the discarding rates of blood and blood component. background: storage performance of platelets (plt) is associated with age of the donor. the risk for plt with poor storage performance, characterized by high lactate production and rapid acidification of a plt concentrate (pc), shows a positive correlation with age. we wished to explore whether high lactate production was associated with donor health issues. aims: to investigate high lactate production by stored platelets in relationship to donor health. methods: single-donor pc were collected by apheresis or prepared from buffy coat and donors were evaluated who could be marked as 'rapid acidifiers'. in total, apheresis pcs and pcs from whole blood were included in four studies. information about donor health was obtained either from the blood bank information system or using questionnaires. in some donors, the lipid profile was measured from plasma, and the diabetes marker hba c from red cells. triglyceride levels > . mmol/l and hba c levels > mmol/mol were defined as high. results: twenty two percent ( / ) of the donors were marked as 'rapid acidifiers' and % ( / ) of these donors had health issues. 'rapid acidifiers' were of age , - (median, range) years. three groups of donors can be distinguished: a) donors affected by metabolic syndrome, prediabetes and type diabetes, indicated by high cholesterol and/or triglycerides, high hba c and/or the use of medication to treat diabetes. b) donors affected by vascular diseases who reported or used medication to treat high blood pressure. c) "other" donors who used other medication to treat various other conditions. the remaining 'rapid acidifiers' ( %) did not have high triglyceride or hba c levels and did not report health issues. summary/conclusions: pcs with rapid acidification by high lactate production are mainly collected from older donors with health issues. we postulate that high lactate production by stored plts is associated with health issues, and we will combine detailed donor information (health and behavior) with in vitro quality for a significant number of donations. background: the development of applied biotechnologies requires a search and creation of new methods of cells' functional completeness analysis. the instrumental assessment of platelets quality for the selection of the most effective donors, quality assessment of platelet concentrates for short and long-term storage and for the selection of platelets for cryopreservation is in demand in blood service. assessment of platelets morphofunctional status is possible using morphological studies of various platelet granules fractions (makarov, med. alfavit, ). among the biologically complete platelets there is a special population of cells, the so-called granule-rich platelets (grp). these cells contain the largest number of cytoplasmic granules (more than visually distinct granules). it is established that grp have increased viability and functional activity. earlier we found a correlation between the grp level in blood plasma and shift of the redox potential value in blood plasma after cryodestruction of platelets (tsivadze et al., doklady physical chemistry, ). it was suggested that the shift of the redox potential may be partly due to the release of the low molecular weight antioxidants contained in functionally complete platelets outside the cell. in turn, the concentration of low molecular weight antioxidants can be estimated using the cyclic voltammetry. aims: the aim of the study was to estimate of cyclic voltammetry method possibilities for quality assessment of platelets. methods: the functionality of platelets was examined in platelet concentrate (pc) obtained by apheresis ( . ae . /ll). voltammetric analysis in pc before and after the platelets cryodestruction was carried out on platinum electrode in the potential range from À mv to + mv using a potentiostat ipc pro l and saturated ag/agcl electrode as reference. for the morphofunctional analysis platelets were vitally stained with fluorochrome stains trypaflavin and acridine orange. microscopic examination of platelets was carried out using confocal microscope nikon eclipse i. the following parameters were evaluated: concentration and percentage of platelets with granules and concentration and percentage of grp. results: voltammetric studies in pc show that there are two oxidation peaks of low molecular weight antioxidants on voltammogram at potentials + mv and + mv. analysis of pc before and after the cells cryodestruction showed that changes in the height of oxidation peaks occur, indicating an increase of antioxidant content in blood plasma. at the same time a correlation between the changes in the height of oxidation peaks and the grp content in the sample was found. in samples with reduced initial grp content (less than %) after the cells cryodestruction significant changes in the height of oxidation peaks were not observed, regardless of the total number of cells in the pc. summary/conclusions: in conclusion, voltammetric analysis allows to indirectly estimate the population of functionally active platelets that in combination with other methods of analysis can serve to assess the quality of platelet products. background: determination of hemoglobin derivatives in blood is one of the most important studies in clinical laboratory diagnostics, especially during the storage of donor blood and its transfusion. concentration of hemoglobin derivatives can be changed during redox process. aims: to show the possibility of using non-linear fitting method to calculate concentrations of hemoglobin derivatives during reduction-oxidation processes. methods: for this we performed model biophysical experiment, in vitro. blood samples were collected into edta microvettes from healthy donors (sarstedt ag and co., germany) during prophylactic examinations. all the donors gave their consent to participate in the study. a suspension of erythrocytes was prepared in pbs buffer with ph . . we used ultraviolet (uv) irradiation of blood or nano as oxidizing agent. the drug cytoflavin (stpf "polisan", russian federation) was used as an antioxidant. in our study we used digital spectrophotometer (unico , usa) to measure the absorption and scattering of light ( . nm step). the method of nonlinear fitting was used to find the concentrations of hemoglobin derivatives. the empirical spectrum d l (k) exp was approximated by the theoretical curve d l (k l ) theor , which fits the experimental curve in the best way. under approximation the light absorption by different hemoglobin derivatives was considered in model. simultaneously effects of rayleigh light scattering on structures with size d<< k (coefficient s) and light scattering on particles with size d≥ k (coefficient k) were taken into account: d l (k l ) theor = e hbo ,l c hbo l+ e hb,l c hb l+ e methb,l c methb l+ e hbno,l c hbno l+ e methbno -,l c methbno -l+ e methbno,l c methbno l+k+s/k l ( ), where e h,l is the molar absorption coefficient for each hb h derivative at given wavelengths k l , c h is the concentration of the derivatives hb h , l is the thickness of the solution layer, d l (k l ) is the optical density of the substance, k and s are the parameters of the model. results: we determined the concentrations of hemoglobin derivatives without any additional chemicals in blood. there were measured experimental spectra for different agents action on blood. it was shown that concentration of methb increased after uv irradiation and nano action (up to %). there were calculated c h for each hb h derivative. it was established that theoretical curves coincide with experimental data with good accuracy (r = . ). incubation of rbcs with cytoflavin leads to reduction of methb to hbo . summary/conclusions: the determination of hemoglobin derivative concentrations by the method of nonlinear fitting (without adding special chemical agents to blood) can be used for measurement of carboxyhemoglobin in blood during toxic state of organism. also it is important for assessment of rbcs quality before blood transfusion. background: the use of in line leukoreduction filters have been highly expanded in iranian blood transfusion centers within the last decade in order to provide sufficient leukoreduced blood fractions from healthy safe frequent blood donations to be supplied to the leukocyte sensitive patients. leukoflex lcr , the dominant brand of such filters procured by iranian blood transfusion organization, is the most updated generation of the filters used around the world. aims: in this study, it is tried to recover the trapped leukocytes from this novel filter by different buffering systems and having optimized the elution mode, the cell differential of the viable recovered white blood cells were determined by flow cytometry. methods: having passed the routine virological tests, eight leukoflex lcr leukoreduction filters freshly used in tehran blood transfusion center were daily collected and each were back flushed by a self-designed mechanical system (a peristaltic pump, a triple junction with regulator part and an air pump) using various conditions and additives for pbs buffer at different phs in order to find the highest recovery yield for leukocytes. the optimized elute was characterized by flow cytometry for subcellular profile to be determined. results: it was illustrated that a system consisting of pbs (without cacl and mgcl ) in ph . containing mm edta and %(w/w) dextran without additive amounts of triton x was the most optimized buffering system for lcr filter back flushing. total cell content was also determined as . * granulocytes, . * lymphocytes and . * monocytes using auto hemoanalysis and flow cytometric methods. summary/conclusions: in addition to partly compensating of the overhead expenses inflicted by application of leukoreduction filters on healthcare system, the results will assist blood organization system to be more classified in rational profile design, future cell therapy strategies and exceptional blood management. also, the recovered cells could be of significance in stem cell science, cellular interaction studies as well as novel molecular developments in drug discovery. vox sanguinis ( ) results: three lines of strategy are in place to pursue self-sufficiency of the largest number of pdmps. first strategy line: maximizing the yield of driving proteins, represented by immunoglobulins (ig) and albumin; this was assured by csl behring with a yield of . g ig ( % intravenous -privigenand % subcutaneous -hizentra) and g albumin (alburex) per kg plasma fractionated, corresponding to . g ig and . . g albumin; based on present demand, this represents % and % self-sufficiency, respectively, for naip regions. second strategy line: ensuring other products from plasma fractionation; the fractionator granted . g fibrinogen (riastap) and . . iu vwf/fviii (haemate p) per year, which corresponds to the present demand of naip regions for both products, but it is under the full potential of plasma, thus providing a high margin of safety in case of increased demand (now the case of fibrinogen). third strategy line: exchanging cryoprecipitate, fibrinogen and vwf with italian regions whose plasma is fractionated by other companies to obtain prothrombin complex concentrates (pcc -kedcom) and antithrombin (atked) as to satisfy naip regions demand; this strategy allowed a supply of . . iu at and . . iu pcc, capable of ensuring self-sufficiency for naip regions until . summary/conclusions: in italy, differentiation of plasma contract manufacturing among companies with different portfolios allowed naip regions to obtain a significant contribution to self-sufficiency from vnrd plasma for a variety of pdmps by different and complementary strategies consisting in maximizing the yield and the portfolio of proteins from the fractionator and exchanging products among regions for other pdmps at high demand but not included in the portfolio of a single fractionator. plasma check system: a valuable tool for plasma freezing validation and monitoring. background: the validation of plasma freezing processes may result problematic in the monitoring/control of critical process parameters (cpp). in in italy , litres of plasma were produced and frozen. aims: in order to assist plasma freezing validation and cpp monitoring, of the italian bes performing plasma freezing utilize the plasma check system (pcs), a system able to record, store and certify the temperature (t) detected at the core of "surrogate" bags during the entire freezing session, consistently with gmp requirements. pcs is patented and commercialized by expertmed srl, verona, italy (http://www.expertmed.it). methods: pcs consists of parts: a) "surrogate" bags (check-bags) of and ml corresponding to the average standard volumes of the real products, containing a fluid validated to simulate the thermal behaviour of plasma; b) a mobile probe (cryo-med) positionable at the core of the check-bags; c) a dedicated software (memo-track). plasma freezing session data are tracked via barcode/rfid and can be consulted by the pcs that associates blast freezer code, operator code, cryo-med and check-bag. data on plasma freezing are stored in a shared folder and transferred to the be information system. the pcs can also be used to check and monitor the out-of-storage variations of core t of frozen plasma unit, i.e. during labelling and packaging procedures, thus allowing to establish optimal timeframes and operations and suitably validate these procedures. in the period - , at the pievesestina be of emilia romagna region , plasma units were frozen so as to allow complete freezing within to a temperature below À °c, in , freezing sessions, using the pcs both for process validation, change control and for the systematic monitoring of core t at each freezing session. furthermore, at the bologna be tests on the out-of-storage conditions of plasma units were carried out to revalidate the procedures of labelling and packaging. results: out of , freezing sessions carried out at the pievesestina be, ( . %) were detected to fail to reach À °c at the core of the check-bags within . of the latter, in most cases ( %) a technical error in the activation of the cryo-med was identified. in addition, the pcs was systematically utilized for periodical revalidation of the freezing procedures. the tests performed at the bologna be to validate the out-of-storage procedures of frozen plasma labelling and packaging allowed to modify the operating procedures in place so as to establish optimal timeframes and operations. this prompted corrective actions regarding: i) number of units to be taken out of storage sites at each labelling session (< units), ii) labelling time (< ), iii) optimal storage t (À °c vs. À °c), iv) optimal time between two openings of storage sites (> ). summary/conclusions: the pcs is a valuable system for plasma freezing validation and monitoring, as well as to perform monitoring and control of the whole pathway of frozen plasma in the be. it is a technologically advanced, easy-to-use and costeffective tool that can efficiently replace other traditional methods commonly used for the above-mentioned purposes. assessment of blood group matching quality using six sigma metrics background: six-sigma metrics provides a general methodology to evaluate a process performance on a sigma scale. implementation of six-sigma for quality assurance can benefit the health care sectors. one of the most important health care sectors is blood transfusion service. for that reason, maintaining a high quality in blood transfusion service is required. pathogen in activated plasma is one of the main products that are provided by the blood transfusion service. the process of producing pathogen inactivated plasma involves blood group matching step. the quality of this blood group matching is extremely significant for the delivery of plasma that satisfies the recipient need. aims: the aim of this study is to assess the quality of blood group matching of pooled plasma units using six sigma metrics, and to clarify the potential implementation of six sigma metrics as a quality management tool. methods: this retrospective study was conducted in the component preparation lab of kuwait central blood bank. the twelve months (january -december ) data of pooled fresh frozen plasma units were recruited and examined. the data was separated to data without double check ( months) and data with double check ( months). data statistics and analysis were conducted by the use of six sigma metrics. results: in a sample size of from the first six months a mismatch was found which equals dpmo and . sigma metric. and in a sample size of from the second six months a mismatch was found which equals dpmo and . sigma metric. out of the whole pooled units were found to be mismatched. some of which were found to be discarded as abo discrepancy, broken, or expired. other was still available in the system, while the rest of the mismatched units were issued. summary/conclusions: using the six sigma principle the study presents a successful assessment of blood group matching quality. as a . sigma metrics obtained from the first months, were shifted to a sigma metrics of . in the second months, after the addition of a double-checking step to the blood group matching of pooled plasma process. the implementation of these metrics in our laboratory quality management has been shown to be very beneficial. in which six-sigma metrics were able to clarify the reduction in blood group matching errors. although six-sigma benefits in major quality improvements and helps to reach an error free laboratory services, yet it presents a new challenge to laboratory practitioners. currently, the hemophilia a patients treated with factor viii concentrated as the first line of therapy but it is more expensive and the supply is not sufficient so for now they have not used factor viii concentrate as prophylaxis therapy. for some cases, hemophilia patients in indonesia depend on subsidy from the world federation of hemophilia. the first handicapped concentrated case is just for therapy not for prophylaxis. big blood centers in indonesia produce routinely fresh frozen plasma (ffp) and cryoprecipitate-anti hemophilic factor (ahf) as replacement therapy for hemophilia a, but its content and safety of factor viii from ml ffp need to be improved. nowadays, there is an available kit for producing minipool cryoprecipitate (mc) that has better safety and quality but it is available as liquid products, stored in very strict and specific temperature (À °c). prophylaxis therapy for hemophilia patients needs a stable product, easy to use and convenient treatment for patients. aims: to analyze the content and safety of f viii with minipool cryoprecipitate (mc) and lyophilized mc for home therapy. methods: we produced mc; mc as the control, mc were lyophilized with excipient and mc without excipient. we analyzed the number of factor viii, the safety, and stability. we count the erythrocyte, leukocyte and platelet residual in mc using flow cytometry. we also measure the ph, osmolality, solubility to learn its stability after storage at days at room temperature ( - °c) and blood bank refrigerator temperature ( - °c) at central blood transfusion services (cbts). results: we found the content f viii with excipient is higher ( . iu/ml) than without excipient ( . iu/ml) and the storage at blood bank refrigerator ( - °c) is better than at room temperature ( - °c) . in both group, there were no residual cells and bacterial found in mc. no significant difference in the ph, osmolality and solubility in both groups. summary/conclusions: the lyophilized mc with excipient stored at blood bank temperature ( - °c) is better than room temperature. this experiment will be continued to know its stability in extended storage time. background: peptic ulcer disease (pud) is a multifactorial and complex disease, and it affects a wide range of people in the world. however, a perfect therapy for pud has not yet been available at present. therefore, we provided a novel therapeutic approach for pud patients and observed its effect in this study. aims: we provided a novel therapeutic approach for pud patients and observed its effect in this study. methods: in this randomized controlled trial, pud patients residing in chongqing were enrolled from to . they were randomly assigned to two groups: (a) a control group used only rabeprazole, and (b) a platelet-rich plasma (prp) group that received a combined therapy of autologous platelet-rich plasma (aprp) and rabeprazole. the aggregation rate of aprp was measured via aggregation remote analyzer module. the therapeutic effect was assessed via the ulcer size and the symptom score. all data were recorded and analyzed statistically using spss. results: a total of patients were included ( patients as control group) and ( patients as prp group) in the analysis. we found that the aggregation rate of aprp is not affected in ph . after treatment with pepsin. our results showed that there were no significant differences between the prp group and control group before the treatment, and there was also no significant difference in healing time between the two groups in different variables. however, regression analysis revealed that the healing time was . d less in the prp group than in the control group, and the patients with higher symptom scores in the initial examination need more time to heal in treatment. summary/conclusions: this study showed an encouraging preliminary result that aprp has a positive result in the peptic ulcer patients, and it seems to be a better choice for refractory pud patients. despite the further follow-up studies are needed to determine the duration of efficacy of aprp, the approach will be helpful for improving the pud treatment in clinical. background: the croatian institute of transfusion medicine (citm) collects, produces and distributes blood components in an area of . million habitants. annually, it collects about , whole blood and , apheresis donations. platelet concentrates (pcs) are more inclined to bacterial contamination due to storage conditions that favor bacterial replication. the citm decided to evaluate the mirasol pathogen reduction technology (prt) system as it offers the possibility to work with a non-toxic, non-mutagenic compound that upon uv illumination induce nucleic acid damage, reducing the risk of septic transfusion. aims: the study objective was to evaluate quality of pcs treated with the mirasol prt system for platelets and stored in tpas+ for days at °c on a platelet shaker. methods: pcs were produced according to the citm's s.o.p., either through pooling of bc with tpas+, "wbd", or through apheresis collection using two devices: the fresenius amicus, "ad" and haemonetics mcs+ system, "mcd". pcs were stored in % plasma and % pas and mcd were subsequently evaluated also in % of plasma and % pas. identical pcs were produced with a pool-split protocol to be prt-treated or serve as untreated control. pcs were treated with the mirasol system according to manufacturer's instructions. qc parameters, such as yield, ph and swirl were measured at days , and . bacteria sterility test was performed at day for a sample of all treated platelets. protein content of pcs produced routinely at the citm was determined to assess accuracy of plasma carry-over calculations for all processed pcs. results: mirasol-treated wbd (n = ) and ad pcs (n = ) stored in % plasma showed at day an average ph ≥ . ; swirl ≥ . and yield = . . their untreated counterparts showed average values for ph ≥ : , swirl ≥ . and yield . - . . mcd stored in % plasma (n = ) that underwent prt showed at day average values for ph = . , swirl = . and yield = . . control mcd showed average values for ph = . , swirl = . and yield = . . mcd stored in % plasma (n = ) that underwent prt showed average values for ph = . ., swirl = and yield = . . their untreated counterparts had average ph = . , swirl = . and yield = . . total protein content in pcs derived from wbd (n = ), ad (n = ) and mcd (n = ) was g/l, g/l and g/l, respectively. while the coefficient of variation of wbd and ad ranged from % to %, plasma products respectively, the one of mcd reached %. all prt-pcs were negative for bacterial growth at day . summary/conclusions: mirasol treated wbd and ad produced according to citm current s.o.p. were quite similar to untreated controls at expiry, on day and passed the requirements of the eu guidelines ( th edition). quality of mcd units met eu criteria at day ; swirl decreased significantly at day which might be explained by the variability in plasma content of mcs+ -derived platelets, challenging the accurate calculation of illumination index for the mirasol treatment. all mirasol treated pcs showed minimal platelet loss at the end of storage. as the implementation of pr had to be cost-neutral it could only be implemented for~ % of the annual produced buffy coat platelet concentrates (bcp) (~ . bcp/year) and required a change in the bcp production method. the primary aim of the implementation was to offer increased blood safety to our most vulnerable patients. the secondary aim was to ensure that we built-up enough routine experience with pr to enable us to quickly ramp-up the production of pr-bcp to % if there were an outbreak of an emergent pathogen in the madrid region. aims: to verify if we could produce~ % pr-bcp without increasing the overall production cost (opc) for bcp. also evaluate the impact of pr on overall scrap rates of bcp, outdate rates and usage of other safety measures. methods: we compared opc for bcp between the pre-pr period ( ) . this cost was offset by substituting a semi-automated production method for bcp, which was used in to produce . % of bcp-units. a manual double dose buffy coat production method (dd-bcp) in combination with pr enabled us to reduce the bcp-disposables cost by . %. despite the moves from a semi-automated to a manual production method the overall scrap rates during production decreased in by . %. the extension of max. storage time from to days for % of the bcp-units that were pr resulted in decreasing our overall outdating rates by % (versus ). this reduction in outdating rates reduced our opc in by . %. in we gamma-irradiated . % fewer bcp-units, but this had only a minimal impact on the opc. summary/conclusions: results of this study confirmed that we reached our initial objectives of producing~ % pr-bcp without increasing the overall production cost (opc) of bcp. it enabled us to offer increased blood safety to the most vulnerable patients. we built-up enough routine experience with pr so we could quickly rampup the production of pr-bcp to % if there were an outbreak of an emergent pathogen in the madrid region. background: irradiation of red cell units is undertaken to prevent transfusion-associated-graft-versus-host-disease (ta-gvhd) in immuno-compromised patients. while irradiators using radioactive c-ray sources are primarily found in blood establishments, they require regular recalibration and supplementary safety measures. xirradiation has been shown to have similar biological effectiveness to c-irradiation and does not require a radioactive source. there is international interest in moving away from gamma sources to reduce vulnerability to terrorism. although damaging, impacts of irradiation on red cells are well recognised. only a limited number of studies have compared red cell component quality following cand x-irradiation for both standard volume red cell concentrates (rcc) and neonatal red cell splits (rcs). aims: to compare the in vitro quality of rcc and rcs when subjected to cor xirradiation on day of storage then stored for a further days. rcs were also irradiated on day of storage as that is most common practice in nhs blood and transplant (nhsbt). methods: four rcc were pooled and split into arms on day of storage, with units in each arm. all units received an irradiation dose of . - . gy. two arms remained as standard volume rcc and were either cor x-irradiated on day of storage. the other two arms were both split into rcs on day of storage before being irradiated on day (early arm) or day (late arm) of storage. for each replicate in these arms, splits were c-irradiated and splits x-irradiated. all arms were tested a day prior to irradiation and , and days post-irradiation for red cell quality parameters: haemolysis, intracellular atp and , dpg, supernatant potassium, glucose and lactate, ph and red cell microvesicle release. the rcc arms were sampled over storage; while for the rcs arms, split was tested on each testing day post-irradiation. a -way anova was used to detect statistical differences over storage between cand x-irradiation for the same components. results: all components produced were within nhsbt specification for volume, haemoglobin and haematocrit. there were no significant differences in red cell in vitro quality parameters studied over storage between cand x-irradiated units, for standard volume arms or neonatal arms and whether rcs were irradiated early or late in storage. moreover, all arms were within haemolysis specification for the end of storage (> % of units with < . % haemolysis) and % of units had atp levels above the recommended minimum for acceptable post-transfusion survival ( . lmol/ghb). both haemolysis and potassium levels at the end of storage for the standard c-irradiated rcc were comparable to our laboratory's historic data for the same component. summary/conclusions: in summary, the storage quality of rcc and rcs post-xirradiation did not differ from c-irradiation in this study, providing reassurance that either method could be used in routine manufacturing. a pajares herraiz , c coello de portugal , m morales , f solano , c perez parrillas , a rodriguez hidalgo , t diaz rueda and m flores direccion, regional transfusion center toledo-guadalajara transfusion service, toledo hospital complex, toledo transfusion service, general university hospital of guadalajara, guadalajara transfusion service, hospital nuestra señora del prado de talavera de la reina, talavera regional transfusion center, regional transfusion center toledo-guadalajara, toledo, spain background: the regional transfusion center of toledo-guadalajara (rtc) manages the collection, processing and distribution of blood components for the hemotherapy area of castilla la mancha (spain) that serves general hospitals (hospital complex of toledo (hct), university general hospital of guadalajara (ughg) and hospital nuestra señora del prado de talavera (nspt)) and the needs of , inhabitants. by also managing the hct transfusion service, it facilitates the handling of stocks. since , rtc has initiated pathogen inactivation (pi) for a part of its platelet components(pc) with the intercept blood system (cerus) using a photochemical treatment with amotosalen and ultraviolet-a. this system allows the inactivation of a broad panel of pathogens and leukocytes, extending the shelf-life of the cp from to days. this affects the expiry and discards of this blood component, allows a better management of the inventory and has an influence on production costs. aims: the objective was to evaluate the influence of pi in the production of cp at rtc and the expiry in the hemotherapy area during the last years divided into four periods ( results: pc were predominantly obtained from whole blood collections with % of bc platelets/ % of apheresis platelets. % of the available bc were used in production for period a and % for periods b, c and d. after wastes of approximately . %, the distribution of pc was stable for the periods studied. pc were distributed for period a, pc for b, pc for c and pc for d. the % of pi platelets with -day shelf life available in the hospitals was limited to % during period a. it was then increased to . %, . % and % for periods b, c and d respectively. the percentage of wastes was stable at . - . % but the discards due to expiry went down from . % (period a) to stabilize at . % in periods b and c and . % in period d. in the general hospitals the expiry went down from % to . %(hct), . % to . % (ughg) and . % to . %(nspt) respectively. summary/conclusions: greater control of pc stocks through historical analysis and consumption projection, together with it tools and the use of pi pc with -day shelf life allowed reducing discards for expiry from . % to . % in the last period analyzed at rtc and the major hospitals of the hemotherapy area. this has a great value in cost-reduction and improves inventory management and the efficiency of the processes. background: blood centers are faced with many challenges including availability of concentrate platelets as well as ensuring highest quality of the product. overcoming the shortage of platelet apheresis by using pooled platelet derived from whole blood units separated using automated standardized system, which can assist blood banks to meet the increase demand in platelets. the pathogen inactivation (pi) technology can improve the quality of the product by mitigating the risk of transfusion-transmitted diseases (ttd) and residual white cells, resulting in minimizing non -hemolytic transfusion reactions. however, the pathogen inactivation treatment must not impact the platelet quality and functionality significantly, as well as the patient safety. aims: evaluate the quality of pooled platelets derived from whole blood (five interim platelet units), separated using reveos automated blood processing system (terumo bct), pooled in % donor plasma and pathogen inactivated by amotosalen/uva technology. methods: five interim platelet units (ipus) produced with reveos device (terumo bct) from single whole blood donations, were pooled with a platelet pooling set (terumo bct) and leucodepleted with a lrf-xl filter (haemonetics). thirty pools have been included in this study, the units were treated using a large volume cerus intercept processing set for platelets according to the manufacturer's instructions and stored until day . the swirling was determined by visual inspection. the volume and yield content were assessed preinactivation and after treatment by pathogen inactivation with a cell counter (dxh- , beckman coulter), rbc contamination was also measured preinactivation with a cell counter (beckman coulter), bacterial contamination was assessed by automated blood culture with a bact/ alert system (biomerieux). the ph of the platelet units was assessed with a phmeter (jenway), and residual amotosalen levels were assessed by an hplc assay. results: the impact of amotosalen/uva pathogen-inactivated pool platelet products quality were assessed. the pre and post-inactivation of the units showed a swirling score of - . the average volume per unit of the pre-inactivation was ml ( - ml) and post inactivation was ml ( - ml), with average volume loss during inactivation was ml ( - ml), corresponding to % ( - %). the average platelet yield per unit pre-inactivation was . ( . - . ) and post inactivation . ( . - . ) with an average platelet loss of % ( - %) . the average rbc contamination per unit ( . - . rbc/ml). the culture tests were negative, the average ph at day was . ( . - . ), average ph at day / was . ( . - . ). the average residual amotosalen concentration post treatment was . lm ( . - . lm). summary/conclusions: the quality of pathogen-inactivated pool platelets tested, met the criteria set by aabb guidelines. the volume and platelet loss were in acceptable range, in alignment with previously published data. a residual amotosalen concentration below lm is considered safe and acceptable by french and german authorities. the evaluated data support the reasonable assurance of quality and effectiveness of the device when used in accordance with indication for use. background: the implementation of a pathogen inactivation process (pi) allows the redesign of processes to obtaining safe blood components by reducing the need for additional testing for pathogens detection, minimizing the residual risks (such as the infectious window period for those pathogens that are detected as usual), eliminates the need for selective tests (eg cytomegalovirus serology test) and complements gamma irradiation given its ability to inactivate white blood cells. in addition, the routine implementation of pi reduces the incidence of bacterial infection in recipients of blood components and allows blood services to proactively protect the blood supply against future emerging infections. aims: to verify the functional integrity and viability of platelet concentrates after being inactivated of any pathogenic agent, to be used as safe and functional components for transfusions. methods: a total of independent platelet concentrates were studied. platelets are donated through a process called plateletpheresis according to the established norms, after the process, platelet concentrates were submitted to pi on the intercept blood system tm platform with uv-a illuminator; an immediate sampling of each donation of platelet concentrates was carried out taking a sample of ml pre-inactivation and another sample post-inactivation ( h after pi). the platelet viability of each sample was evaluated by demonstrating the cd p expression marker by flow cytometry. once processed, platelet concentrates were released as safe components for donation. compiled the experimental data of the platelet count with platelet activation marker with respect to the total platelet, a comparative, nonparametric test of wilcoxon was carried out between two measurements (pre vs post) and the platelet viability after pi was determined. results: a total of independent platelet concentrates were studied, where the average percentage of pre-inactivated platelets with expression of the cd p marker, was %, while the percentage of functional platelets post inactivation was %, this result only shows that the functionality of the platelets is not being altered after the inactivation process. the wilcoxon test confirms that there is no significant difference between platelet activity pre-and post-inactivation, with a % confidence level. summary/conclusions: the process of photochemical treatment with amotosalen hydrochloride and long-wavelength ultraviolet light (uva) applied to platelet concentrates provides functional products without alterations in platelet function to be transfused. background: treatment of platelet concentrates (pcs) with pathogen reduction technologies is widely implemented in blood establishments to reduce the risk of bacterial contamination and to face the presence of new emerging agents in blood components. aims: the reduction of antioxidant power (aop) could be a quality control test to prove the complete viro-inactivation treatment. this evaluation has the goal to study the feasibility of the method from "abonnenc et al., transfusion, " in another blood service, assessing the aop of platelet units treated by intercept technology. methods: the aop is expressed in edel value, one edel being equivalent to lmol/l ascorbic acid. repeatability, intermediate precision and accuracy were determined. linearity was evaluated using the linear regression and the calculation of pearson's coefficient (r²). limit of quantification (loq) was determined by measuring aop using nacl samples to define the background. roc curves were used to determine a threshold to discriminate pcs before and after treatment. a distinction was realized between men and women and between apheresis (a) pc and buffy coats (bc) pcs. a one-year evaluation was assessed on pcs before and after treatment on the routine production. results: the coefficient of variation for the repeatability was less than %. for the intermediate precision, the coefficient of variation was less than %, but for the pcs after treatment, this result rose up to %. the r² value for the linearity was . %. the detection limit corresponded to a result of edel and the loq (equal to xsd) is edel. concerning roc curves, the men apcs threshold was . edel compared to women apcs with . edel. the threshold for bcpc was edel. all of these results had % of specificity. below this threshold, intercept treatment was considered to be executed. about the one-year experience on routine pcs production, apcs ( women and men) and bcpcs were tested. all of the bcpcs and women apcs were under the threshold after treatment. concerning men apcs, . % of the pcs after treatment were not under the threshold. summary/conclusions: the device validation was satisfied. for the one-year evaluation and concerning men group apcs, the threshold found by abonnenc et al. was edel. our study showed a threshold with % specificity and % sensitivity at . edel which is much lower. specificity was favored compared to sensitivity but the analysis should be revised to adapt the threshold to get higher sensitivity. this can lead to reduce the non-conformity and allows measuring the aop only after treatment. for women, our threshold was found at . edel compared to . edel for abonnenc et al. concerning sex in apcs, results were statistically lower in women group than men group before and after treatment. and for bcpcs, the two populations (before and after treatment) were very distinguishable and our threshold ( edel) was lower than abonnenc threshold which was at . edel. in conclusion, edel threshold enables the segregation and depends on the preparation process adapted in each blood service. aims: this study has the goal of measuring antioxidant power (aop) level in plasma units treated by mb technology. the aim is to use such a test as a quality control assay for documenting the execution of pathogen inactivation treatments during the preparation of plasma units. methods: aop measurements were performed using a potentiostat electrochemical analyzer. a -ll volume of sample is deposited over the electrodes on a single-use microship. the aop is expressed in edel value, one edel being equivalent to lmol/l ascorbic acid and reflects the redox status of the plasma units. different protocols were established to understand the role of mb, the illumination and the filtration on the aop variation measure: ) complete treatment, ) plasmas with mb without illumination, ) plasmas without mb with illumination and ) plasmas without mb without illumination. ten dosages on men donor samples, except for protocol where n = , were realized during the viro-inactivation process, t corresponds to a dosage of plasmas before treatment, t the plasma after the mb dry tablet passage, t is the time after illumination and t corresponds to the final product (after filtration). results: in each protocol with mb, an increase was observed after addition of mb before illumination. after illumination, the edel values decreased for about less than %, which was expected because of the degradation of mb in its photoproducts during the illumination. in the series and , the illumination seemed to have an effect by itself, with or without mb because the aop increased. the final filtration has the goal to eliminate the residual mb and its photoproducts. after this step, the aop values fell down. the series was a confirmation of the efficacy of the filter to remove the mb as shown by the decreased aop in t ( ae edel at t and ae edel at t ). however, in the absence of mb (series and ), the results at t and t were not statistically different. summary/conclusions: the filtration decreases the aop rate, except when there was no mb. the results of non-complete viro-inactivation treatment allow concluding that the measure of aop rate may not indicate that the treatment was completed or not since significant differences before and after treatments were found in the non-complete treatment series. vox sanguinis ( ) background: the intercept blood system (ibs), a photochemical treatment with amotosalen and uva, is used to inactivate pathogens and leukocytes in plasma. the intercept tm plasma processing set (cerus bv, netherlands) was modified to incorporate plastic containers in non-pvc materials sourced from alternate suppliers and connecting parts and accessories in non-dehp pvc formulations, making the system dehp-free. the final storage container was modified with a higher contact surface with plasma to limit the thawing time. proportion of units with a fibrinogen concentration ≥ . g/l was % (> % required). mean recovery fviii fibrinogen after ibs treatment and frozen storage were % and %, respectively. residual platelets were < /l, leucocytes < /l and red blood cells < /l. all units had a protein content > g/l. residual amotosalen was below lm in all post-cad samples. the concentration of tat complexes was slightly reduced after treatment and frozen storage. concentrations of c a and c a were significantly reduced with the cad treatment. the plasma thawing time in a water bath at °c was consistently short ( - min). summary/conclusions: pathogen inactivated plasma units (ffp-a-ibs and ffp-wb-ibs) prepared with dehp free intercept processing sets retained in vitro characteristics which meet the quality standards for therapeutic plasma. the process did not activate coagulation or complement. reducing ffp thawing time from routine - to - min is an important benefit for emergency use. background: plasma coagulation factor concentrations usually differ for individual donors, therefore pooling of whole-blood derived plasma units moderates high or low coagulation factor concentrations and ensures transfusion of more standardized blood components. moreover, pooling contributes to dilution of reactive antibodies and may reduce the risk of non-hemolytic transfusion reactions and trali. additionally pathogen inactivation reduces the risk of transfusion-transmitted infections, and non-hemolytic transfusion reactions as well as gvhd through inactivation of residual lymphocytes. aims: assessment of the impact of plasma pooling and pathogen inactivation on the standardization of blood components and plasma quality. methods: the study included experiments. for each experiment male-donor, abo-compatible whole-blood derived plasma units (≥ ml) were collected from different donors and pooled using the donopack optipool plasma pooling set (cerus europe b.v.). each of the -unit pools were split into equal minipools which were subsequently treated with the in intercept blood system (cerus europe b.v.). then, each minipool was split into (≥ ml) therapeutic units. samples were collected before and after pooling as well as after inactivation to assess the coagulation factor content (fviii, fix, fibrinogen, vwf antigen using elisa) and coagulation time (aptt, pt). the study-analysis included samples from five pools from single plasma units respectively ( background: biotin (bio) is an alternative to radioactive red blood cell (rbc) tracers which allows one to concurrently track in vivo multiple cell populations labeled at different bio densities. in american clinical trials, multi-labeled biorbc have been transfused in man to assess their survival (mock et al, transfusion, ) . in these studies, the different biorbc populations were monitored by ex vivo flow cytometry analysis using streptavidin. so far, the biotinylation reagents biosulfonhs was not complying with good manufacturing practices (gmp). moreover biorbc, with bio ≥ lg/ml, have induced immunization of the recipient, in rare cases (schmidt et al, transfusion, ) . this represents an obstacle regarding the regulatory european authorities. aims: the aim of this study is to describe a procedure of biotinylation of rbc intended for clinical trials while refining the levels of bio ≤ lg/ml. methods: sterile status is met throughout the process. rbc are taken from standard rbc concentrates and treated with biosulfonhs of gmp-grade ( to lg/ml) recently commercialized. washing buffer is of injectable-grade. biotinylation efficacy is controlled by flow cytometry with streptavidin conjugated to different fluorochromes: phycoerythrin (pe) or brilliant violet (bv ). results: labeling with biosulfonhs of gmp-grade or non gmp-grade is comparable and populations of rbc could be easily distinguished between themselves and from unlabeled blood cells. biosulfonhs (lg/ml): (mfi . ), (gmp mfi ; non gmp mfi . ), (gmp mfi ; non gmp mfi ), (gmp mfi ; non gmp mfi ). streptavidin-bv brighter than streptavidin-pe is a promising tool because it amplifies by . the signal of fluorescence and allows a good differentiation of the populations of rbc treated with only , , and lg/ml biosulfonhs. summary/conclusions: this preliminary study explores the feasibility of multilabeled biorbc production for clinical trials. the benefits of this approach are to overcome the need for non-radioactive tracers, to follow simultaneously various populations of rbc and consequently to limit the number of volunteers, and to reduce the risk of immunization using bio ≤ lg/ml. background: rejuvenation is aiming to revert ageing-related disease development. heterochronic parabiosis studies revealed eotaxin in young and old murine blood as a regulator of brain aging and neurogenesis. umbilical cord blood (ucb)-borne factors including tissue inhibitor of metalloproteinases (timp ) and neonatal immune cells also contributed to rejuvenation in animal models. human platelet lysate (hpl) is commonly used by us and others for highly efficient cell propagation in vitro (burnouf et al., biomaterials, ) . published data indicate only limited differences between adult and ucb-derived hpl, partly questioning enigmatic rejuvenation effects. aims: to verify candidate regenerative factors in neonatal blood products we compared protein contents of neonatal and adult plasma and platelets, respectively. methods: heparinized ucb samples (n = ) were centrifuged within h to collect neonatal platelet rich plasma. aliquots from apheresis platelet concentrates (n = ) were used as adult counterpart. platelet concentration was adjusted to - / l. plasma supernatants and platelets were obtained by centrifugation and platelet pellets were re-suspended in saline. after two freeze/thaw cycles at À °c/ °c for platelet lysis (npl; apl) the platelet fragments were removed by centrifugation. the protein content was analyzed with a proteome profiler tm array. nine samples of each group were pooled to avoid individual donor variations. a threshold of , au spot density was defined as cut-off. data were analyzed by graphpad prism using two-way anova. results: semi-quantitative evaluation of analytes per array revealed significant differences. in plasma samples and platelets and analytes were detected above cut-off, respectively. in neonatal plasma we found more highly prevalent proteins (> , au spot density) compared to adult plasma ( / vs. / ). thirteen proteins were significantly elevated in neonatal plasma including growth/differentiation factor (gdf ), platelet derived growth factor aa (pdgf-aa) and serpin e (p < . ). more highly prevalent proteins were detected in npl ( / ) compared to apl ( / ), and proteins were significantly elevated including vascular cell adhesion molecule- (vcam- ), platelet factor (pf /cxcl ), epidermal growth factor and lipocalin- (p < . ). in adult samples only proteins were significantly higher in plasma and three proteins in apl compared to the neonatal groups (p < . to p < . ). summary/conclusions: we detected significant differences in regenerative growth factor and cytokine contents of neonatal and adult plasma and platelet samples, respectively. additional experiments are underway to further characterize their impact in distinct functional readouts. background: the production and storage conditions of platelet (pl) products intended for transfusion are constantly evolving and need sometimes in vivo evaluations in clinical trials to ascertain whether the platelets have retained their ability to survive in the circulation. this requires that the transfused platelets can be distinguished from the recipient's circulating platelets. labeling of platelets with biotin (bio) affords to track in vivo and concurrently, multiple cell populations covered with various biotin densities as already described for red blood cells (mock, transfusion, ) . surprisingly, there is only one study describing the transfusion of human biopl (stohlawetz, transfusion, ) . so far, the biotinylation reagent bio-sulfonhs was not complying with good manufacturing practices (gmp), which represents an obstacle regarding the regulatory authorities. aims: the aims of this study are ) to describe a procedure to label injectable human platelets with densities of biotin, ) to evaluate the impact of biotinylation on platelet functions, ) to track human biopl in the circulation of the mouse. methods: platelets are taken from standard platelets concentrates and treated with . and lg/ml biosulfonhs of gmp-grade, recently commercialized. main platelet functions are assessed in vitro. human biopl survival is evaluated in immunodeficient nsg-mice treated with liposome-clodronate to eliminate macrophages and to prevent rejection. circulating human biopl are detected ex vivo by flow cytometry with streptavidin phycoerythrin. results: using trap ( lm), p-selectin externalization reveals a normal capacity of secretion for all biopl. gpiba and gpiibiiia expression is not affected by the biotinylation process. biopl have the ability to aggregate: using arachidonic acid ( mm), amplitude of aggregation is . ae . % (bio ); . ae . % (bio . lg/ ml); . ae . % (bio lg/ml). using collagen ( . lg/ml), amplitude of aggregation is . ae . % (bio ); . ae . % (bio . lg/ml) . ae . % (bio lg/ml). the biopl populations could be easily distinguished between themselves and from unlabeled blood cells in the mouse circulation during more than h. after h, the mean fluorescence intensities are . ae . for unlabeled circulating mouse platelets, . ae . and . ae . for circulating human biopl covered respectively with . and lg/ml biotin. summary/conclusions: this labeling approach should be helpful to evaluate new platelet products in vivo and represents an alternative to radioactive tracers. it allows to follow simultaneously different platelet populations and consequently limits the number of volunteers in clinical trials. background: severe ocular surface diseases, dry eye syndrome, persistent and recurrent corneal epithelial defects and diabetic or neurotrophic keratopathy are mainly successfully cured by standard treatment protocols. however, not rarely does refractory to these usual treatments appear, especially with serious forms of disease. in military medical academy, autologous serum eye drops -auto seds and autologous platelet lysate -apl eye drops have been being applied in the treatment of ophthalmological patients in these categories, who were previously resistant to standard therapy. aims: to show the achieved results of therapeutic use of autologous blood products (auto seds and apl) in the treatment of ophthalmological patients who previously had not responded to conventional therapysingle center experience. methods: auto seds are prepared by taking autologous blood into tubes (bd vacutainer, cat, ml) and apl in tubes with anticoagulants (greiner bio-one, acd-a, ml). control on tti of every patient and sterility of every series has been conducted. before and after the treatment, subjective ocular discomfort (ocular surface disease index -osdi), objective parameters of the tear film (schirmer's test, rose bengal, tear breakup time -tbut) and measuring of epithelialization zone were analyzed. apl, obtained from platelet-rich plasma which had been frozen, unfrozen and diluted with nacl solution, up to %. auto seds were administered in the form of % eye drops. results: auto seds have been applied to ophthalmological patients ( men and women), previously resistant to standard therapy. in total treatments were performed (each lasted days). for successful curing, one or two treatments per patient, in average, were applied. apl has been used multiple times to one patient with sj€ ogren syndrome and severe multiple tropical corneal changes. all ophthalmological patients had subjective improvements (the average pre and post treatment osdi scores were . and . respectively). also, objective progress was present in % of all patients (p < . ). summary/conclusions: the use of auto seds and apl in the treatment of ophthalmological patients, previously resistant to standard therapy, is in constant increase, because of its simplicity and low expenses. apl has turned out to be better than auto seds for patients with severe trophic changes, because apl contains larger amounts of the nerve growth factor, tgf-b, vegf and platelet derived growth factor. however, a larger number of clinical cases is needed for future conclusions. background: whole blood (wb) has recently regained favor in treatment of massively bleeding patients in military and civilian settings. platelets (plts) are a vital component in clot formation. as a component of wb, it is critical that they maintain functionality throughout storage. red blood cells (rbcs) stored in hypoxic/ hypocapnic conditions preserve high level of , -dpg while reducing storage lesions stemming from oxidative stress. , on the other hand, effects of steady hypoxia (pco ~ - mmhg) on plts contained in leukoreduced wb is poorly characterized. aims: examine the effects of hypoxic conditions on plt function and microvesicle (mv) formation in wb stored hypoxically (h) and conventionally (c) for -week storage at - °c. methods: units of wb were collected at mayo clinic rochester blood donor center from normal healthy volunteers into ml cp d. wb was leukoreduced using plt-sparing filter (terumo wb-s) then split into control (c) and hypoxic (h). h-wb was processed by the oxygen-reduction bag (hemanext, lexington ma) and unit was stored in o -free bag. ml of wb were collected from each unit at day , weeks , , . plt counts, agonists (thrombin receptor agonist peptide (trap), adenosine diphosphate (adp) and collagen stimulated platelets aggregation, nonactivated and agonists activated plt surface expression of phosphatidylserine (ps, annexin-v binding), p-selectin, fibrinogen receptor (pac- binding), and microvesicles (mv) were measured by coulter counter and digital flow cytometer. paired student t-tests were used to analyzed differences in degradation rates; significance: p < . . results: h-plt counts declined to~ % by the o -reduction process, while similar decline was observed after week in c, and thereafter remained steady. plt activation (ps) increased over time (h >> c after processing; c increasing more rapidly during storage). p-selectin increased over time (h < c), while pac- showed large increase after week, then remained steady (h << c). plt activation by trap or adp declined modestly over weeks (~ %) while h-plt showed additional~ % reduction for all time points. collagen activation for c-plt increased after week ( %) and gradually increased to % after weeks (~ % reduction with h compared to c). plt-derived mv (cd and cd /annexin v) increased~ -fold over storage time; day mv levers were significantly higher for h, but subsequent increase rates were similar or lower. total number of plt-derived mv (cd a) in wb supernatant increased -fold after weeks for c, while h suppressed increase to -fold. (majority of the trends described above showed significant differences between h and c.) summary/conclusions: plts were activated over -week period when stored at - °c in leukoreduced wb, accompanied by a modest loss of agonist-induced activation. oxygen reduction treatment initially activated h-plts, while subsequent increase in activation rates were suppressed compared to c-plts. wb plts retained activatability, and hypoxic condition showed only modest further reduction on the activatability. hypoxic wb may provide higher quality wb for trauma patients if the levels of initial plt activation can improved during oxygen reduction procedure. methods: after informed consent, eligible patients were randomized to either first receive autologous followed by allogeneic seds or first receive allogeneic followed by autologous seds. each sed treatment phase was one month, separated by one month of patient's standard treatment (wash out period) between sed treatment phases. the patients each donated ml whole blood from which the autologous seds were prepared. allogeneic seds were prepared from blood from never-transfused male donors with blood group ab. all serum was diluted : by adding saline, and aliquoted in an eye drop dispensing system (meise, schalksm€ uhle, germany). at each visit, the osdi was determined using a validated questionnaire, with higher scores reflecting poorer outcomes. the results were analyzed intention-to-treat, and a random effects linear mixed model for cross-over design was used. results: in total, patients were enrolled, of whom were excluded because they failed the autologous blood donation. background: the following blood components for non-transfusional use (bcntu) are produced in our transfusional center (tc): ) allogeneic platelet gel (pg), derived from buffy-coats (bc) and human cord blood platelet gel (cbpg); ) autologous serum eye drops (sed). the creation of both types of platelet gel started in but only in we confirmed the process for daily production: these blood components are used to treat pediatric patients with epidermolysis bullosa. the sed, produced from , is dedicated to treat patients with dry eye syndrome. aims: production and storage bcntu. methods: the whole process production of bcntu is traced on the transfusional informatic system (emonet-insielmercato), under the same conditions of another blood transfusional components. the process takes place in closed circuit using the laminar flow hood. ) pg production starts from the bc resuspended in plasma that are not used for daily platelet concentrates, instead the cbpg is produced using cord blood units that are not used for hematopoietic transplant. both have a platelet concentration between - /ll and negative blood cultures, required by the italian law; the units are frozen at À °c and last -year. pg and cbpg must be activated with calcium gluconate or batroxobin to be used. ) the ophthalmologist's patients, with dry eye syndrome, donate ml of autologous blood; the serum is separated and after the dilution with a balanced saline solution ( %) are divided in boxes containing single-dose vials each: they are stored at À °c and they last one year. negative blood culture was evaluated. results : background: candida albicans is the most common pathogen detected in fungal infections. aims: in this study, we aimed to evaluate the in vitro antifungal activity of volunteerderived platelet rich plasma (prp) against c. albicans atcc strain and the possible effects of certain chemokines, kinocidins that might play a role in this activity. methods: prp from nine volunteers were derived by using magellan prp â kit. % calcium gluconate was used to obtain autologous thrombin. c. albicans isolates with a final yeast concentration of cfu/ml and cfu/ml were inoculated on sabouraud dextrose agar at the st , nd , th , th and th hours of incubation to reveal the antifungal activity of autologous thrombin-activated prp. the colonies were counted after - h of incubation at °c. chemokines and kinocidins (platelet factor- , interleukin- and thymosin-b ) were also measured simultaneously by elisa method. results: compared with the pbs-control group, the prp- group showed that the antifungal activity was still going on at the th hour. the difference in colony production between the two groups at th hour was statistically significant (p < . ). it was observed that the antifungal activity continued at the th hour, decreased at the th hour in the group prp- group. although the same amount of prp was used and the same amount of chemokine and kinocidins were released in both groups, the concentration of c. albicans was considered to be important in the detection of more effective prp- group. although there was an increase in il- levels by hours in the two prp groups by elisa method, no antifungal effect was detected against c. albicans. it was observed that decrease in tmsb values results from the antifungal activity on the advancing hours in the prp groups. whereas pf- did not act an antifungal activity on prp- and prp- . summary/conclusions: even in our study group where the highest platelet counts were obtained at the lowest concentration, c. albicans reproduction could not completely eliminated as mentioned in the literature. repeated doses of prp applications, such as drugs used in patients, may have longer duration of action and even complete repression of reproductive outcomes. background: generally, blood is available in developed countries for transfusion. sometimes, transfused or previously pregnant patients form alloantibodies to red cell antigens and rarely, to antigens of high prevalence. this case focuses on a twoyear-old girl, of pakistani descent, diagnosed with neuroblastoma stage iv with anti-in b and -e. although the publications indicate that % of the pakistani, indian or iranian populations are in(b-), it was discovered that this blood type is exceedingly rare. an international search was required to ensure blood product availability for chemotherapy and autologous hematopoietic progenitor cell transplants aims: illustrate the response of the public to a powerful story of a child needing rare blood for treatment and international collaboration for provision of very rare units. methods case report: a two-year-old patient's sample was referred for antibody identification. the patient had received four transfusions ( ml of red cells) in the preceding -day period. hgb level fluctuations were consistent with decreased transfused red cell survival. following the last transfusion of ml, the hemoglobin decreased from . to . . anti-in b , and a ficin-only reactive anti-e was identified in the serum and anti-in b in the eluate. the monocyte monolayer assay predicted the anti-in b to be clinically significant ( % reactivity). transfusion of antigen neg units once obtained, resulted in a stable transfusion response. although it was expected that in(b-) blood would be more easily sourced, only two donors in the usa were in (b-) e-. as - units of blood were requested for the post-transplant period, a national and international search was initiated, as was a robust media appeal to donors resulting in many donors for an intense domestic screening effort in the usa. the search of the who international rare donor panel by the international blood group reference laboratory revealed three known in(b-) e-donors; two british and one australian. they were contacted, recruited, collected and shipped to the usa with the work of the american rare donor program (ardp) staff and the isbt working party on rare donors (isbt wprd) members in each of the countries. results: the intense media coverage of oneblood (the florida blood center collaborating on treatment with the hospital) included online news outlets (youtube, facebook) resulted in over , responses from national and international potential donors to be tested for in b . isbt wprd members were sent the web information of potential donors identified in their countries by the ardp. over , samples from blood centers and associated laboratories tested with anti-in b by oneblood. two new in(b-) donors were discovered ( . %); but both typed e+, thus were not a match for the child. summary/conclusions: this intense media coverage and the overwhelming donor response was unprecedented in our experience. the coordination and cooperation among the numerous blood centers reflect the deep dedication of the blood banking community to the well-being of special patients in need. this case illustrates the response potential that a powerful story and a medical appeal for exquisitely rare blood utilizing social media and other online news outlets can generate. background: blood platelet units are generally stored in blood banks for - days, afterwards they are discarded. prepared infusible platelet membrane (ipm) from fresh or outdated human platelets correct the prolonged bleeding times in thrombocytopenic animals such as rabbits. infusible platelet membrane (ipm) as a platelet substitute may be the most feasible approach to reach the target market. our previous experiments have shown that ipm has a hemostatic efficacy to shorten bleeding time without any adverse effects in rabbits. aims: abnormal toxicity is the european pharmacopoeia standard for assessment of biological products which the test material is administered to the mice. in this study, abnormal toxicity of ipm was evaluated in experimental animal model such as mice to assure the safety of ipm without any evidence of serious toxicity. methods: in this experimental study, infusible platelet membrane (ipm) was prepared from outdated platelet concentrates. platelet concentrates were pooled, disrupted by freeze-thaw procedure, pasteurized for h to inactivate the possible viral or bacterial contaminants with a sodium caprylate stabilizer, formulated by sucrose and human serum albumin and finally lyophilized. at first, the test for sterility is carried out under aseptic conditions for ipm vials and then we injected . ml of ipm ( mg/kg) intravenously between to seconds into each health mice, weighing - grams. these tests were performed according to eu pharmacopeia monographs. results: in the sterility test no evidence of microbial growth in our product is found. the abnormal toxicity test will be passed if none of animals die during h after injection. if more than one animal dies, the preparation fails the test. if one of the animals just dies, the test is repeated. in our experiment all five mice were alive after h of ipm injection. summary/conclusions: in this research the results showed that ipm as a platelet substitute is free of abnormal toxicity with adequate safety and it may be used in human clinical trial studies as a feasible approach to develop a platelet substitute in the future. however, further studies are required to confirm the different aspects of its safety as well. the success of such investigations may affect patients' care in transfusion medicine in the future. a substantial number of infants, especially premature infants, are unable to receive adequate amounts of their mothers' milk for a variety of reasons. the world health organization recommends that infants, especially preterm and ill infants are fed with quality-controlled donor milk if they cannot be fed with their own mother s milk. due to the possible transmission of the human immunodeficiency virus many human milk banks closed in the s, therefore the availability of donor milk has decreased. aims: we analyzed the processing of donor milk and the required laboratory tests to establish a human milk bank within our blood donation service in cooperation with the department of neonatology at the frankfurt university hospital. methods: based on the recommendations for promoting human milk banks in germany, austria, and switzerland (efcni) we evaluated the manufacturing steps and the quality controls require to establish a human milk bank. background: for patients suffering from severe ocular surface disorders treatment with blood derived serum eye drops (sed) is a highly effective therapy. autologous sed, prepared from the patient's own blood, is used preferably. for this approach we have more than years of experience. if auto-sed cannot be manufactured due to medical reasons allogeneic sed present an alternative. since years, the allogeneic approach is well established in our center. aims: retrospectively evaluation of our experience with allo-sed. methods: in germany manufacturing of allo-sed is only possible as an "individual healing attempt". for each patient experienced regular ab -identical male donors without blood borne disease, who never received blood products and not taking any kind of medication are selected. additionally, donors must pass a questionnaire excluding any form of dry eye syndrome. allo-sed are manufactured directed for each individual patient according to the process for auto-sed in a closed system. patient files of our serum eye drops donors were screened for patients receiving an allogeneic treatment. data concerning indication for allo-sed, contraindication for phlebotomy, problems with donor selection and manufacturing, as well as serological and microbiological testing results were obtained. clinical results were evaluated © the authors vox sanguinis © international society of blood transfusion vox sanguinis ( ) (suppl. ), - by ocular surface disease index (osdi) and patient's questionnaire, asking for subjective benefit, symptom reduction, possible side effects, consumption and comparison with artificial eye drops or, if applicable, with auto-sed. furthermore patients are undergoing regular ophthalmologic examination within a special consultation for dry eye syndrome at our hospital. results: patients were identified receiving allogeneic sed, patients had been treated autologous previously. in total, allogeneic sed have been produced times since june . indications were ocular gvhd (n = . %), neurotrophic keratopathy (n = . %), mucous membrane pemphigoid (n = . %), sj€ ogren syndrome (n = . %) and secondary keratoconjunctivitis sicca by virtue of chemotherapy, meige syndrome, rosacea, morbus bruton (n = . %). contraindications for autologous donation were underlying disease (n = . %), poor venous access (n = . %), low haemoglobin (n = . %), low body weight (n = . %), very young age (n = . %), circulatory disturbances (n = . %) and lack of response to auto-sed (n = . %). some patients presented more than one contraindication. manufacturing problems were: lipemic donor plasma (n = . %), high donor haemoglobin (n = . %) and unspecific positive serological findings (anti-hbs n = . %). microbiological testing was sterile every time. as side effects one case of allergic reaction, suspected as serum protein allergy, appeared. clinical outcome can be considered equivalent to ased. subjectively, all patients benefited from the therapy and reported an alleviation of their symptoms. for some indications (highly active gvhd) allo-sed might even be the better option. summary/conclusions: considering our previous experience, allo-sed seem to be a safe and equally effective alternative to auto-sed for patients unable to donate blood. in case of urgent indication, timely supply can sometimes be difficult. to overcome this disadvantage licensing allo-sed as a new blood product with the possibility of production and storage in advance would be a desirable goal. in addition supply would become even safer by preparing allo-sed according to a quarantine principle like ffp. abstract withdrawn. background: vernal keratoconjunctivitis is a chronic, recurrent bilateral inflammation of the outer ocular layer. mostly affected are children and young people and the condition is more common in boys. the disease presents with eye pruritus (itching eye), photophobia (sensitivity to bright light), excessive tearing and foreign eye syndrome. severe cases manifest with diffusion of overgrown papillae usually of the upper eyelid, bursting of the connective tissue barriers and appearance of giant papillae that press on the cornea. corneal ulceration is a severe complication of vernal keratoconjunctivitis that may induce scarring, corneal neovascularization and occasionally perforation. treatment of keratoconjunctivitis mainly relies on steroids, mast cell stabilizers, antihistamines, immunosuppressive drugs (cyclosporine), artificial tears, contact lensdressing, cryotherapy and surgical papillae removal. we present the case of a year-old girl with corneal ulceration who was applied artificial tears after traditional methods of treatment proved unsuccessful. aims: the aim was to share our experience on artificial tears therapy applied in ophthalmic disorders. methods: autologous blood ( ml) was collected into disposable, sterile transfer bags used for routine blood component preparation (no anticoagulant) and incubated for h at °c. the clot was then removed by centrifugation and the serum containing erythrocytes was press extracted. centrifugation was applied again to obtain serum free of cellular components. the serum was then divided into . ml segments (capsules)and the artificial tears applied to the left eye daily. results: ulcer healing was reported after weeks of therapy with artificial tears. the dosage was reduced to daily. no recurrence of corneal ulceration was observed after subsequent weeks. summary/conclusions: artificial tears are a safe and effective therapy for ophthalmic disorders in children. background: arv non-disclosure among hiv-positive donors who tested hiv antibody (ab) positive but rna negative (ab+/rna-), so-called false elite controllers, was previously described by our group in south africa, with > % of ab+/rnadonations since testing arv positive. the extent of undisclosed arv use at time of donation represents a significant risk to blood safety in a country with a growing treated hiv population. aims: to establish the prevalence of arv non-disclosure among four subgroups of hiv-positive donors in south africa along with demographic correlates of non-disclosure. methods: south african blood donors are screened by a self-administered questionnaire, which includes questions on current hiv status and arv use, followed by a semi-structured personal interview. specimens for hiv, hepatitis b and c testing are collected at time of donation. based on id-nat (procleix, grifols) and antibody (prism, abbott; western blot) testing, hiv-positive blood donations were classified as acute (ab-/rna+), recent (ab+/rna+, limiting antigen avidity [lag] odn ≤ . ), longstanding (ab+/rna+, lag odn > . ) and potential elite controller (ab+/rna-) cases. stored plasma from these donations were tested for four arv drugs using qualitative liquid chromatography-tandem mass spectrometry (detection limit . lg/ml). chi-square tests were used to assess associations of hiv case type, gender, ethnicity, age, donor type, and donor clinic (fixed, mobile) type with arv non-disclosure. results: during , donors tested hiv-positive of whom had samples available that were tested for arvs. the overall prevalence of undisclosed arv use was . % (n = ) with efavirenz most frequently detected ( ), followed by lopinavir ( ) and nevirapine ( ) . potential elite controller cases had the highest proportion of detectable arv ( / ; %) (p < . ) followed by longstanding ( / ; . %) and recent ( / ; . %) infections. none of acute hiv cases tested positive for arvs. there were no associations between arv use and gender or ethnicity. however, older ( to years) hiv-positive donors ( / ; . %) were significantly more likely to test positive for arv than younger ( to years) donors ( / ; . %) (p < . ). arv use was more frequent among first time ( / ; . %) than in lapsed ( / ; . %) or repeat ( / ; . %) donors (p < . ). donors at mobile clinics had significantly higher arv non-disclosure than donors at fixed sites ( . % vs . %; p = . ). summary/conclusions: the . % prevalence of undisclosed infection and arv use among hiv-positive south african blood donors is alarming. higher rates of nondisclosure among first-time donors was expected, but non-disclosure among repeat and lapsed donors suggests failure in donor education and assessment. the . % prevalence among concordant ab+/rna+ cases may suggest sub-optimal viral suppression. lack of detection of arvs in acute cases should be qualified because the samples were not tested for tenofovir, the most common drug used in pre-exposure prophylaxis. donor motivation for non-disclosure of known hiv infection and arv use needs further investigation, since early arv initiation or infection while on prep could lead to low ab and rna levels, failure to detect hiv-infected donations and transfusion-transmission of hiv. blood bank, rotary blood bank, new delhi, india background: voluntary blood donation ensures safe blood transfusion. careful blood donor selection is of importance to provide safe blood to patients, although new methodologies have also been adopted by blood centers for blood safety and to minimize risk of transmitting infections through blood transfusion. the quality and the availability of blood components depend on the willingness to donate and reliability of the information given by the donors about their own health, including risk behaviour. blood donor history questionnaire is designed to evaluate donor's history in accordance with the guidelines laid down by the fda. donors, once deferred by the blood bank, will be less motivated to return for donation if he is not counseled effectively. it is important to reduce the number of deferrals by good donor comprehension and the centre should have a mechanism to recall temporarily deferred donors aims: the aim of the study is to analyse donor history and test results of those who donated blood with past history of jaundice. based on their history which suggested the type of viral infection they had, these donors were accepted or deferred. data was collected from voluntary blood donors who were screened for blood donation in the year . methods: in this study, donor history was analysed with reference to history of jaundice. jaundice in donors after the age of yrs, history of surgery, blood transfusion, body tattoos and acupuncture treatment within past one year of donation, history of multiple sex partners and related history and intravenous drug abuse history was taken into consideration. donors who revealed past history of jaundice were asked in detail about their illness and recovery. blood was donated by donors from whom the history of jaundice was elicited and it was understood that the type of virus which caused jaundice was not hepatitis b or c. those who could not give the correct history or were not sure of the cause of hepatitis, those individuals were deferred. aims: to assess the performance of this follow-up program in terms of donor participations, successful confirmed positivity rates, and potential reentry rates. methods: eligible donors were tested for hbsag, hcvab, hivab/ag, and tpab with two eias for each marker. samples reactive with at least one assay were tested further with electro-chemiluminescence assay (eca) and reactive samples were considered repeated reactive (rr). tpab reactive donations were re-tested with particle agglutination assay (tppa). samples eca or tppa non-reactive were considered non-repeatable reactive (nrr background: the blood donation service in suhl processes more than . samples annually from whole blood and apheresis donations, testing on average around samples per day. for the last years, serology screening was performed on the architect instruments (abbott) (arc), but will be changed to the alinity s system (aly) by middle of . although the design of the aly assays is based on those of the arc assays, we undertook a thorough evaluation of the four mandatory screening assays detecting hbsag, hiv ag/ab, anti-hcv and anti-hbc. aims: to validate the mandatory screening assays on the new aly system in our lab in terms of sensitivity and specificity, also including samples with known falsereactive results. determine the rate of false reactive results for hbsag, anti-hcv and anti-hiv that may lead to deferrals of donations and donors. methods: for sensitivity, we used known positive samples confirmed by immunoblot or nat. known unspecific positive samples for arc not confirmed by immunoblot or nat were testes for aly also. close to . unselected samples (edta plasma) from routine blood and apheresis donors were tested in parallel on both systems, arc and aly to determine the rate of initial and repeat reactive results. results: all known confirmed positive samples were identical detected by aly. samples with known unspecific reactive results were retested by aly with the following results: / anti-hcv, / hiv ag/ab and / hbsag were found reactive by aly to. one donation from an acute hiv infection in the early seroconversion period was detected by both methods in routine testing. there are no reactive results for aly not already known for arc. the specificity for the screening assays on aly versus arc assays were as follows: ) hbsag aly . % ( % ( / % ( ) vs arc . % ( % ( / ; ) hiv aly and arc . % ( / ); ) anti-hcv aly . % ( % ( / % ( ) vs arc . % ( % ( / . the number of anti-hbc reactive samples did not differ between aly and arc. summary/conclusions: while the switch to the new system is mainly driven by operational efficiency, obviously, the high specificity of the alinity s assay will reduce unnecessary deferrals of donations and donors. abstract withdrawn. background: blood donor selection is the cornerstone for blood transfusion safety, designed to safeguard the health of both donors and recipients. donor safety is targeted by reducing the risk of complications associated with blood donation and transfusion safety by reducing the risk of transfusion-transmitted infections (tti) and other preventable transfusion reactions. there is always a compromise on blood donor safety as well as blood safety during outdoor mega blood donation drives due to various reasons, mainly due to more number of donations within a stipulated time. aims: to compare the blood donor selection patterns between in house blood donations and donations at mega blood donation drives and its influence on donor safety and blood safety in a tertiary care hospital in india. methods: a retro prospective study was done to audit and compare blood donor safety and blood safety over a period of years from january to december . blood donor safety was analyzed by two indicators: donor health questionnaire (dhq) monitoring and blood donor reaction rates and blood safety through tti positivity rates. ( ) during mega blood donation drive. summary/conclusions: a good donor selection is a lengthy process which involves pre-donation information and advice: this is usually provided in a leaflet, especially about transfusion-transmitted infections (and the associated risk factors) and the potential risks of donation, filling of dhqs by the donor himself, donor interview: conducted by a qualified medical specialist trained in donor selection process and health assessment at the end of the interview to declare if the donor is eligible to give blood or deferred temporarily or permanently. it was observed that seroprevalence rates, number of donor reactions and incompletely filled dhqs were more among blood donations at mega blood donation drives when compared to blood donations during in house collections. this is mainly due huge number of blood donations with in a stipulated time where there is limited time spent on proper donor selection. stringent implementation of who strategy: "safe donor safe blood" is the only way for blood donor and transfusion safety. background: safety of blood transfusion is a great concern especially in crisis countries and during humanitarian emergencies. transfusion transmitted infections (ttis) are one of the major health problem in yemen that are associated with blood transfusion complications. aims: the aim of this study is to determine the prevalence of ttis among blood donors at national blood transfusion and researcher center (nbtrc this contributed to an additional reactivity of . %, thereby total reactivity being . %. % ( / ) of these were hcv reactive & % ( / ) for hbv. the nat yield was in and the viral loads of nat reactives ranged from - x iu/ml for hcv & all the hbv yields had an extremely viral load of < iu/ml. / nat reactive showed sero-conversion after - months with follow-up eclia screening, and of these were hcv reactive and hbv reactives. summary/conclusions: incidence rate indicate that the current risk of transfusion transmitted viral infections attributable to blood donation is relatively high in our country. parallel use of both serology and nat screening of donated blood in countries that have high seroprevalence can improve the blood safety. at our centre, by using best in class serology and nat technologies, we were would add an extra layer of safety to blood supply by interdicting samples from donor with recent infections. abstract withdrawn. abstract withdrawn. ( / , ) . the both hiv-rna and hcv-rna detected donors by nat were identified in the window period. summary/conclusions: in this study, we found that nat could detect infected cases with hbv-dna, hiv-rna and hcv-rna which were forgotten by serological methods therefore, nat is a sensitive screening method to detect low viral load and shorten the window period of the virus infection to ensure the safety of blood transfusions. service du sang, croix rouge de belgique, namur, belgium background: due to enhancement of kits specificity and machines throughput, roche elecsys â technology is a potential partner for blood donations screening laboratories. aims: the aim of the study was to assess the performance of the elecsys serology assays on a cobas e equipment for clinical specificity, analytical sensitivity and reproducibility. background: deceased donors are the primary source of organs and tissues for transplantation but the risk of infectious complications in the recipient is high and is the main cause of morbidity and mortality after transplantation. to minimize the risk of infections by organ or tissue transplantation, donors should be tested for anti-hiv- / , hbsag, anti-hbc, anti-hcv, and syphilis. further laboratory tests may be required depending on the history of the donor and on the tissue properties. certain grafts can be donated after circulatory death of the donor; however, the absence of the heartbeat may change dramatically the blood composition by e.g., haemolysis and proteolysis. this may have an impact on test performance and lead to false results. therefore, an assay validation is needed for testing of cadaveric samples. aims: a validation study was performed to demonstrate the suitability of elecsys hbsag ii, anti-hbc ii, anti-hcv ii, hiv combi pt, hiv duo, syphilis, htlv-i/ii, and chagas for the use in cadaveric samples from non-heart beating donors. methods: as the basis for validation, we followed the recommendations of the paul-ehrlich-institut (pei) "proposal for the validation of anti-hiv- / or hiv ag/ ab combination assays, anti-hcv assays, hbsag and anti-hbc assays for use with cadaveric samples". comparison of spiked samples from living donors and cadaveric donors was used to demonstrate accuracy. to determine precision, two cadaveric specimens were tested in several replicates. acceptance criteria were implemented according to the pei recommendations. results: results were found to be within specifications requested by the pei recommendations for all tested assays summary/conclusions: the evaluated results support the extension of the use of these assays with cadaveric specimens. background: in developed countries, blood donors are routinely screened for a range of blood borne viruses (hiv, hbv, hcv and htlv) using highly sensitive screening tests. this has dramatically improved the safety of blood supply. however, transmission by transfusion of unknown or unsuspected viruses remains a continuing threat. this is particularly relevant considering that a significant proportion of transfused patients are immunocompromised and more frequently subjected to fatal outcomes. in developed countries, blood donors are routinely screened for a range of blood borne viruses (hiv, hbv, hcv and htlv) using highly sensitive screening tests. this has dramatically improved the safety of blood supply. however, transmission by transfusion of unknown or unsuspected viruses remains a continuing threat. this is particularly relevant considering that a significant proportion of transfused patients are immunocompromised and more frequently subjected to fatal outcomes. aims: in this context, metagenomic analyses of viral content in blood donations collected in geographical zones recognized as "hotspot" for viral emergence represents a suitable approach without any a priori for the identification of a potential emerging viral risk that may compromise blood safety. methods: in the framework of a viral discovery program founded by the french national agency for medicine security (ansm in french), more than plasma samples collected in sub-saharan africa countries ( ) ( ) and the amazon region of brazil ( ) have already been analysed by metagenomics. results: although no viral sequence could be described as novel (i.e. new species or even a new genus), we unexpectedly identified a feline bocavirus in two donors from mauritania. a large diversity of known viruses that are not part of the regularly monitored agents were also observed, among which anelloviruses, hpgv- (formerly known as gbv-c), papillomaviruses, herpes viruses, parvovirus b , chikungunya virus, enterovirus, and various small circular viruses (circo-, cycloand gemycircularviruses). while no significative differences was observed in the higher classification of detected virus (above families/genera) between africa and brazil, we observed variations at the sequence level allowing better resolution of the genetic diversity for several viruses (for example characterization of hpgv- genotypes). summary/conclusions: overall, the absence of novel viruses in blood samples collected across countries of two distant continents is reassuring regarding threats emergence. however, continuous monitoring of prospective blood banks should be continued. summary/conclusions: after the high peak observed in during the first period, this study shows that the decrease in the seroprevalence of viral markers is continuous over the next five years. the second period is marked by an irregular evolution of seroprevalence but with lower levels than the first period. the recruitment of new donors allows a quantitative increase in donations. however, improving the quality of blood products essential condition of transfusion safety is achieved through retention of recruited blood donors. background: in blood screening laboratories, samples may be transferred between automated serological and molecular instruments, and the potential for sample contamination is a serious risk to the integrity of nucleic acid testing (nat) results. the sensitive limit of detection (lod) for hiv and hcv nat assays combined with the high viral titers encountered in specimens from patients with acute infections presents a challenge for maintaining the sample integrity of negative specimens. at additional cost per test, this risk can be reduced with single-use filter pipette tips. aims: we evaluate the efficacy of applying induction heated washes to a non-disposable pipettor on serology instruments-alinity s, alinity i, and architect i sr (abbott diagnostics)-to preserve the integrity of samples transferred to a downstream molecular instrument, the m realtime (abbott molecular diagnostics), which amplifies viral nucleic acid targets exponentially. methods: in this application of induction heating, the metallic pipettor warms under its own resistance to coil-induced electrical currents. by sweeping the pipettor through an induction coil, temperatures on the pipettor are elevated throughout its length. single donor high viral titer hiv genotypes a ( . log iu/ml), b ( . log iu/ml), c ( . log iu/ml), crf ( . log iu/ml), crf ( . log iu/ml), and urf ( . log iu/ml), as well as single donor high viral titer hcv genotypes a ( . log iu/ml), b ( . log iu/ml), a ( . log iu/ml), ( . log iu/ml), q ( . log iu/ ml), and t ( . log iu/ml) were used as potential sources of contamination; these genotypes account for the majority of hiv and hcv infections worldwide. on serology instruments, one high viral titer hiv or hcv specimen and three consecutive susceptible negative samples (hiv/hcv rna negative human plasma, abbott molecular diagnostics) were tested on an hiv ag/ab combo or anti-hcv immunoassay (abbott diagnostics), and this schema was repeated four times per positive specimen. induction heated washes occurred between all samples processed on the serology instruments. the first susceptible negative from each testing block, with approximately ml of residual sample volume, was then tested using the . ml abbott realtime hiv assay (lod copies/ml) or . ml abbott realtime hcv assay (lod iu/ml) and an hcv ag immunoassay (lod . fmol/l; abbott diagnostics). study acceptance criteria required that any susceptible negative sample had no detectable level of hiv or hcv rna. results: all first susceptible negative samples (n = per platform per virus schema) run on alinity s, alinity i, and architect i sr using induction heated washes after a high viral titer hiv specimen or hcv specimen were hiv ag/ab combo nonreactive (< . s/co) and reported no detectable level of the hiv rna target, or were anti-hcv nonreactive (< . s/co) and reported no detectable level of the hcv rna or core antigen targets. summary/conclusions: while precautions should continue to be taken for samples run on molecular instruments, the integrity of samples originally tested on the alinity s, alinity i, and architect i sr was preserved for downstream molecular testing through the use of induction heated washes. aims: increasing the safety of blood and blood products -motivating the blood donors to be regular donors methods: national reporting system showed the high prevalence of ttis among first blood donors in compares with the regular donors. in per . . donations, % % of confirmed positive hiv, % of hcv, and % of hbv cases has been reported among first blood donors. in the end of a national program named "pre-donation screening tests "has been developed and has been implemented in high prevalence provinces in whole country. based on this program, all first blood donors who accept in donation sites, if after donor selection process are eligible to donate blood, they refer to give just a blood sample for screening ttis tests. after months, the invitation letters and smss send to the donors who have negative results for all screening ttis tests, and they can be eligible to donate blood after another donor selection process. in , about . % of all donations have been rejected because of at least one of hiv, hcv, or hbv confirmed positive results, while this reject rate in was . %, which shows a significant decreasing the ttis prevalence among blood donation from to . the prevalence of hiv, hcv, and hbv among donations has been decreased significantly in compared with the . prevalence of hiv among donations reduce from . % in to . % in , for hcv and hbv the same results have been experienced, respectively from . % and . % in reduce to . % and . % in . it seems this applied study could effectively scale up the safety of national blood supplies. in addition this intervention could support iranian blood transfusion service to increase the proportion of regular blood donors from . % in to . % in . it means that with increasing the regular blood donor population sizes, the safety of iranian blood and blood products will be more and more scaled up. summary/conclusions: evidence based reports show there is a high rate of prevalence of transfusion transmitted infections (ttis) among first blood donors. so an effective intervention which can reduce the risk of unsafe first blood donation can effectively increase the safety of blood and blood products. pre donation screening tests program in iran can support the national program to decrease the rate of ttis among blood donations from . % in to . % in . abstract withdrawn. abstract withdrawn. background: despite the universal application of viral inactivation and elimination technologies during the preparation of plasma-derived products, the exclusion of infectious donations before any other procedure remains the first essential step as well as the major determinant for the safety of untreated labile blood products. current selection and screening techniques have reduced the risk of viral transmission to very low levels, but there is still a very low but quantifiable risk of transmission through donations beyond routine detection, particularly during the " seroconversion window". "of an infection in a blood donor that is to say during the period when the recently infected donor has not yet developed a serological response. the level of residual risk, which must be as low as possible, is mainly conditioned by the rates of the infections concerned (hiv and hepatitis b virus (hbv) and c (hcv)) to blood donors. summary/conclusions: the evolution of serologic markers is generally satisfactory with continued regression, which has improved particularly for hiv. on the other hand, hepatitis b is still a concern because of its still high rate among new donors. it is desirable to initiate a regular donor vaccination program to protect against hepatitis b. background: blood centres require high throughput assays with a high level of reproducibility to assure consistent results and minimize unnecessary retesting of samples and deferral of donors. in addition, continued economic pressures on laboratory operations demand that assays perform on platforms capable of increased walk away time and enhanced automation in areas of reagent management, retest options, and commodity/waste management. aims: evaluate the reproducibility of hcvab, havab igm and havab igg essays using abbott alinity s when compared to architect i sr. determine repeatability of these tests in alinity s essays. methods: during months a study was conducted where several samples (minimum samples per test) were randomly sorted and tested using alinity s and architect i sr, results were compared using ibm spss statistics â . in order to evaluate repeatability, at least samples with different reactive degrees (high, intermediate and low) per test were repeated, using alinity s, an average of times per sample and it was determined the percentage of coefficient of variation (%cv). results: a total of samples were tested ( for hcvab, for havab igm and for havab igg) using alinity s and architect i sr, and it was ensured that there were no statistically significant differences between results (p > . ). using samples and a total of essays we found the %cv hcvab ranged from to . %. samples were tested for havab igm in a total of essays and the %cv ranged from to . %. havab igg was tested in samples during essays and the %cv ranged from to . %. summary/conclusions: the new automated equipment alinity s system demonstrated no statistically difference when compared with architect i sr and repeatability was ensured. this demonstrates the precision of results generated by this fully automated blood screening analyzer, which helps assure consistent results for the testing and retesting of blood specimens for hcvab, havab igm and havab igg. background: blood centres require high throughput assays with a high level of reproducibility to assure consistent results and minimize unnecessary retesting of samples and deferral of donors. in addition, continued economic pressures on laboratory operations demand that assays perform on platforms capable of increased walk away time and enhanced automation in areas of reagent management, retest options, and commodity/waste management. aims: evaluate the reproducibility of hbsag, hbsab, hbcab, hbeag and hbeab essays using abbott alinity s when compared to architect i sr. determine repeatability of these tests in alinity s essays. methods: during months a study was conducted where several samples (minimum samples per test) were randomly sorted and tested using alinity s and architect i sr, results were compared using ibm spss statistics â . in order to evaluate repeatability, at least samples with different reactive degrees (high, intermediate and low) per test were repeated, using alinity s, an average of times per sample and it was determined the percentage of coefficient of variation (%cv). results: a total of samples were tested ( for hbsag, for hbsab, for hbcab, for hbeag and for hbeab) using alinity s and architect i sr, and it was ensured that there were no statistically significant differences between results (p > . ). using samples and a total of essays we found the %cv hbsag ranged from - . %. samples were tested for hbsab in a total of essays and the % cv ranged from - . %. hbcab was tested in samples during essays and the %cv ranged from - . %. using samples and a total of essays we found the %cv hbeag ranged from . - . %. samples were tested for hbeab in a total of essays and the %cv ranged from - . %. summary/conclusions: the new automated equipment alinity s system demonstrated no statistically difference when compared with architect i sr and repeatability was ensured. this demonstrates the precision of results generated by this fully automated blood screening analyzer, which helps assure consistent results for the testing and retesting of blood specimens for hbsag, hbsab, hbcab, hbeag and hbeab. background: blood centres require high throughput assays with a high level of reproducibility to assure consistent results and minimize unnecessary retesting of samples and deferral of donors. in addition, continued economic pressures on laboratory operations demand that assays perform on platforms capable of increased walk away time and enhanced automation in areas of reagent management, retest options, and commodity/waste management. aims: evaluate the reproducibility of hivag/ab, syphilis and htlv i/ii essays using abbott alinity s when compared to architect i sr. determine repeatability of these tests in alinity s essays. methods: during months a study was conducted where several samples (minimum samples per test) were randomly sorted and tested using alinity s and architect i sr, results were compared using ibm spss statistics â . in order to evaluate repeatability, at least samples with different reactive degrees (high, intermediate and low) per test were repeated, using alinity s, an average of times per sample and it was determined the percentage of coefficient of variation (%cv). results: a total of samples were tested ( for hivag/ab, for syphilis and for htlv i/ii) using alinity s and architect i sr, and it was ensured that there were no statistically significant differences between results (p > . ). using samples and a total of essays we found the %cv hivag/ab ranged from to . %. samples were tested for syphilis in a total of essays and the %cv ranged from to . %. htlv i/ii was tested in samples during essays and the %cv ranged from . to . %. summary/conclusions: the new automated equipment alinity s system demonstrated no statistically difference when compared with architect i sr and repeatability was ensured. this demonstrates the precision of results generated by this fully automated blood screening analyzer, which helps assure consistent results for the testing and retesting of blood specimens for hivag/ab, syphilis and htlv i/ii. , human immunodeficiency (hiv) and hepatitis c (hcv) viruses' infection in blood donors were . %, . % and . % respectively. consecutive positive results for hbv were . % ( / ), for hcv were . % ( / ) and nil for hiv. there was no sample carry over in this. out of consecutive reactive donors were donated for same patients and were related with infected patient which were statistically significant (p < . ). summary/conclusions: among all tti reactive donors . % ( / ) were consecutive reactive. the reason for the same may be process related like sample carry over or reagent carry over or donor related. donor related reasons may be, one of the close relative is reactive for virus and that is transmitted to other family members. in our study reactive donors either had close contacts with persons with history of infective disease or were their first degree family relatives. these findings were found statistically significant (p < . ). this study recommends that in analysis of consecutive positive results in elisa along with looking for procedure/sample error, there is also a need to take retrospective history of donors for close contact with infected patient. background: screening for transfusion-transmitted infections (ttis) is critical in ensuring safety of blood products. transmission of infections through transfusion remains a major source of viral hepatitis especially hbv and hcv. the effectiveness of rapid immunochromatographic test (ict) devices for screening of blood is a concern and needs validation through advanced methods like chemiluminescence immunoassay (clia) and polymerase chain reaction (pcr). aims: the current study was conducted to evaluate the performance and screening effectiveness of commercially available rapid screening kits in comparison with clia and pcr. methods: this single centre, cross sectional study was conducted at the department of blood transfusion services, shaheed zulfiqar ali bhutto medical university, islamabad, from january -june . a total of ten commercially available ict devices and one clia kit (liaisonr xl) were tested for their sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy using positive and negative samples each for hbv and hcv respectively, in comparison with the values determined by pcr. the ict kits included hightop, rightsign, wondfo, accu-chek, fastep, abon, immumed, insta-answer, biocheck and ctk. results: the sensitivities and specificities of ict kits for hbsag were % and % (hightop), % and % (rightsign), % and % (wondfo), % and % (accu-chek), % and % (fastep), % and % (abon), % and % (immumed), % and % (insta-answer), % and % (biocheck) and % and % (ctk) respectively. similarly the sensitivities and specificities of different ict kits for hcv were % and % (hightop), % and % (rightsign), % and % (wondfo), % and % (accu check), % and % (fastep), % and % (abon), % and % (immu-med), % and % (insta answer), % and % (biochek) and % and % (ctk) respectively. the sensitivity and specificity of diasorin liaison murex assay for both hbv and hcv were found to be %, when compared with pcr. the ppv, npv and accuracy were determined accordingly. summary/conclusions: rapid testing ict devices for both hbv and hcv available in pakistan were found to have a variable degree of sensitivity and specificity, when compared with pcr. comparatively expensive but quality methods are more reliable as compared to rapid devices. the data generated will help policy makers to prepare future plan of action and introduce the concept of quality control in blood centres. the analysis has shown that the population of blood donors also included people infected with syphilis. in reference to the number of the tested samples this number is quite significant. the analysis proved the increase in the number of syphilis infections among the blood donors which is consistent with the general trend in the population. summary/conclusions: we have proved that testing blood donors for the treponema pallidum infection increases the safety of recipients of blood and its components and that obligatory testing of donors is fully justified. , and , the use of third or fourth generation serological assays is mandatory for screening of blood donor units for hbv and hcv infection before transfusion. routinely, blood banks in india screen the units by the elisa testing. nat is not very common due to cost constraints. aims: the aim of this study is to determine the frequency and load of hbv dna and hcv rna in hbs and hcv reactive blood donors respectively, and hence it was intended to contribute to determining whether routine hbs and hcv screening of blood donors, using elisa method alone, provides any concrete benefits with regard to hbv and hcv risk reduction or whether the implementation of nat will be of great benefit to low-resource countries like india, which has high prevalence of hbv and hcv. abstract withdrawn. , donors were routinely tested for hbv dna by using cobastaqscreen mpx- and mpx- (roche) or procleix ultrio and ultrio plus id (grifols) assays. obi was confirmed by repeat dna testing and by performing additional serological and molecular investigations on index and follow-up samples. anti-hbs concentrations were determined and anti-hbc antibodies were tested with three distinct commercial clia assays (anti-hbc elecsys roche, architect anti-hbc ii abbott, and hiscl anti-hbc assay sysmex). hbv pre-s/s, precore/core and bcp regions were pcramplified after viral particle concentration and viral amplicons were sequenced. results: hbsag-/dna+ donors ( : , ) including confirmed obi were identified ( : , prevalence). among obi donors, ( . %) tested anti-hbc+/anti-hbs-, ( . %) were anti-hbc+/anti-hbs+, ( . %) were anti-hbc-/anti-hbs+, and anti-hbc-/anti-hbs-primary obi ( . %). anti-hbc-/anti-hbs+ obi donors were significantly younger (mean: years [range: - years]) than those with anti-hbc+/anti-hbs+ (mean: years [range: - years]) and anti-hbc+/anti-hbs-(median: years [range: - years]) profiles (p < . ). hbv vaccination was documented for ( %) of these donors and was reported in one donor but without definitive evidence. extremely low hbv dna loads (range: < - iu/ml) were transiently detected in seven donors during follow up. genotypes identified were genotype b (n = / ) and genotype c (n = / ). preliminary analysis of core protein (n = ) and bcp (n = ) sequences showed no particular genetic feature that could be associated with altered antigenicity or core gene expression. follow-up was available for / anti-hbc-/anti-hbs+ donors ( - samples/donor; range: - months). anti-hbc remained undetectable with all clia assays in these donors except one. low transiently detectable levels of hbv dna were observed overtime with anti-hbs levels fluctuating between and , iu/l. no significant difference in hla-a, -b (except hla-b* more frequently detected in anti-hbc negative obi), and -drb *. summary/conclusions: overall, the . % prevalence of anti-hbs-only in hbv dna positive obi carriers ( : , of total donors) in dalian blood donors confirmed previous reports from south east asia. this phenomenon was not related to core antigenic variations but was significantly associated with younger age of carriers. a particular route and natural history of the infection may be considered. the hypothesis of acute-phase vaccine breakthrough was ruled out in / donors by the over months stability of this serological profile. breakthrough in immunized donors may still be suspected. further studies are needed to evaluate the potential infectivity of anti-hbs-only/hbv dna+ obi carriers, and to characterize the potential viral and immunological mechanisms responsible for this unusual hbv infection profile. confirmatory laboratory, hungarian national blood transfusion service (hnbts), budapest, hungary background: vaccination against hepatitis b virus (hbv) is an effective tool to avoid the infection. in hungary, population born after is considered to be immunized, because inoculation has been mandatory for children as campaign vaccination since . hbv vaccine is strongly recommended for healthcare workers, moreover trips to endemic countries and awareness of individuals could also be reasons of vaccination in immunologically na€ ıve age-groups. since the hbv vaccine contains surface antigen, a recent inoculation can cause reactivity of hbsag screening assays and positivity of confirmatory tests for several days resulting in deferral of donors from blood donation. the former regulation of hnbts, which was valid until december , , allowed the re-entry of donors whose immunization records and negative hbv confirmation of the second blood samples proved that the previous vaccination had resulted in the hbsag confirmed positivity. aims: the aim of this study was to strengthen that vaccination against hbv before blood donation had resulted in the reactivity of hbsag screening and confirmatory assays between and . background: in brazil, the introduction of nucleic acid tests (nat) for hbv-dna detection in the routine screening at public blood banks is relatively recent. at fundac ßão pr o-sangue/hemocentro de são paulo (fps-sp), about , blood donors are submitted to serological screening tests (hbv, hcv, hiv- / , chagas disease, syphilis and htlv- / ) and nat for hiv, hcv and hbv per year. approximately % of the blood donations are discarded due to some reactive result; of these, the hbv discard rate was . % in . aims: our study aims to determine the potential infectious cases among samples that had one or more hbv-reactive screening results (anti-hbc, hbsag and mp-nat-hbv) and verify the different categories of hbv infection (acute, chronic, occult hepatitis b infection (obi) and immunological window). furthermore, to characterize the distribution of hbv genotypes, drug resistance and escape mutations and analyze the risk factors. methods: we carried out a cross-sectional study of roughly , donations from may to december . hbv antibodies and antigen screening were performed using cmia kits architect â -abbott/hbsag and architect â -abbott/anti-hbc. nat screening was performed in minipools (mp) of six samples using kit nat hiv/hcv/ hbv -bio-manguinhos (sensitivity % lod iu/ml for hbv). reagent samples (n = ) that presented one or more hbv-reactive screening results (anti-hbc, hbsag and/or mp-nat-hbv), were submitted to individual nucleic acid extraction and "in house" quantitative real-time pcr-hbv (id-pcr-hbv) targeting the hbsag region (sensitivity - ui/ml). the hbv genotypes and mutation analyses were determined by direct sequencing of the hbv pol-gene/surface-gene and use of the online analysis tool geno pheno [hbv] . . socio-demographic and epidemiological data were also analyzed. financial support: fapesp / - . results: among the hbv reactive samples, were reactive for anti-hbc only ( . %), for hbsag only ( . %) and were reactive for both markers and hbv dna ( . %). routine testing and id-pcr-hbv identified ( . %) samples of active infections that had all hbv reactive/positive tests results. no hbv dnayield samples or hbsagyield or obi were observed. viral loads for active infections samples ranged from . e+ to . e+ cop/ml (median, . e+ cop/ml). hbv sub-genotypes a , a , c , d and f were found in %, %, %, %, and % of the donors, respectively. no reverse transcriptase inhibitor-resistant variants were detected. escape mutations in small hbsag protein shb region were detected in % ( / ), with the following main substitutions c ( x), r, n and g. the mean age of donors with active hbv infection was years, mostly donors were males ( %), mixed ( %) or white ( %) and had concluded high school ( %). summary/conclusions: discard rate due to isolated anti-hbc is high but no obi was found in the blood donor population studied. in addition, no case of immunological window for hbv or hbsagyield was detected. there was a predominance of subgenotype a and mutations associated with escape were found in % of hbv-dnapositive samples. continuous research and surveillance about hbv prevalence among blood donors are needed to maintain and evenly increase blood safety in brazil. background: screening for anti-hbcore antibodies in blood donors is considered to contribute significantly to blood safety, since it reveals donors with occult or probable occult hepatitis b, with variable results in molecular screening, due to very low viral load. however, universal anti-hbcore testing in blood donors, might exclude a considerable number of blood donors in countries with high hbv prevalence and even in countries with low to moderate prevalence, like greece. aims: the aim was to investigate the percentage of blood donors with natural hbv infection (confirmed positive anti-hbcore) or hbv immunization due to vaccination (anti-hbs+ only, due to vaccination) and predict the impact of generalized anti-hbcore testing. methods: during the period - november , all blood donors were asked to give their consensus for additional screening for hepatitis b anti-hbcore and anti-hbs antibodies, besides the obligatory serological and molecular screening, the samples of few donors who disagreed, were not examined. all samples with repeated positive anti-hbcore results, were further examined for anti-hbcore igm and anti-hbe antibodies. furthermore, a new donor sample was requested, to confirm reactivity. the serology results were recorded in an excel spreadsheet. additional data, including age, sex, nationality, number of previous blood donations, abo blood group, family history of hbv infection, hbv vaccination, were also recorded and statistically evaluated. donors were informed of the positive results. results: a total of edta samples were tested using the architect anti-hbcore, anti-hbs, nti-hbcore-m and anti-hbe assays (chemiluminescent microparticle immunoassay (cmia). repeated anti-hbcore(+) occurred in ( . %) samples, among which ( %) were also anti-hbe(+), while anti-hbs was found > m iu/ml in ( . %), between and miu/ml in ( . %), and < miu/ml in ( %). among anti-hbcore positive donors, / were foreigners ( . %) and were greeks, while foreigners consisted , % ( / ) of donors examined. so, anti-hbcore was found positive in , % of foreigners ( / , all from countries with high prevalence for hepatitis b infection) and in , % of greeks ( / ). in total, ( . %) samples had anti-hbs > miu/ml (considered seroprotective for the donor). summary/conclusions: almost half of our blood donors ( . %) were immunized, by vaccination and ( . %) by natural infection. the incidence of natural infection was significantly higher in foreigners ( . % versus , %). if not all anti-hbcore+ donors, % with anti-hbs < iu/ml, might be potentially infectious, especially for immunocompromised patients. if we choose to screen all blood donors for anti-hbcore and reject those with positive results, regardless of the anti-hbs levels, we would probably lose a significant number of donors and jeopardize blood sufficiency. alternatively, we could reject only those with anti-hbs < or < , or choose to selectively screen pre-donation blood donors from countries with high prevalence of hbv infection. following this pilot study, the prevalence of immunization against hbv in large numbers of blood donors from various parts of greece, must be investigated, in order to decide whether to introduce such screening. aims: the aim of this study was to perform phylogenetic analysis of the donor samples with hcv found in the neighbouring villages to determine the nature of transmission. methods: altogether, approximately million blood donor samples were screened with anti-hcv immunoassay (architect anti-hcv, abbott gmbh, wiesbaden, germany) and reactive results were confirmed with anti-hcv line-immunoassays (inno-lia hcv score, fujirebio europe, gent, belgium). based on lia positivity, in samples an association of hcv infection was supposed, because the residence places of donors were in three neighbouring villages situated less than km to each other. pcr was positive in samples. from these samples, hcv sequencing and phylogenetic analysis were performed. fourteen hcv infected samples of general population and of ivd users were also included into the study. results: phylogenetic analysis detected genetic relationship among the hcv virus sequences in donor samples. the most abundant was the a subtype, and it formed two different groups on the phylogenetic tree. according to their genetic distance, a more distant mutual ancestor could be supposed. two samples with b subtype originated from the same village, and their difference was only nucleotides. three hcv from the ivd user control group showed close genetic relationship with the viruses detected in the donor samples. summary/conclusions: based on our phylogenetic analysis, hcv transmission in blood donors could be the consequence of the ivd use and the origin might be related to or primary human sources. during and , a significant increase in the hcv seroprevalence among the ivd users was observed, which was approximately threefold in the rural areas of hungary. our recent findings highlight the importance of the proper donor selection, which can identify the typical signs of the ivd use. moreover, enhancing awareness of blood donors with education is a further significant issue in order to reduce the risk of transfusion transmitted infections. abstract withdrawn. background: in china, the residual risk of transfusion-transmitted hcv has been declining since screening of blood donors for anti-hcv and/or hcv nat from . however, many high sensitivity reagent, using to test blood donors' samples, lead to false-positive results and donors loss. aims: this study intended to establish a donor reentry procedure for hcv screening reactive donors in china. methods: from march to december , there were blood donor samples which were screened reactive or belonged to "grey zone" by elisa and/or reactive by nucleic acid test(nat) at the local blood centers were collected from chinese blood centers. all these samples were sent to institute of blood transfusion (ibt) national reference laboratory where anti-hcv and hcv individual nucleic acid test (id-nat) were conducted. if the results were reactive for anti-hcv, then the samples were tested with a recombinant immunoblot assay (riba). results: based on this study, of donors in the study who could be classified into two categories for hcv status: ( . %) true positive and ( . %) false positive. a total of of donors lost to follow-up, their hcv status cannot be determined with certainty. based on these data, a reentry procedure for hcv screening reactive donors was proposed. summary/conclusions: based on our proposed donor reentry procedure for hcv screening reactive donors, a majority of screening false-positive donors ( . %) can re-entry safely. abstract withdrawn. background: providing safe blood for transfusion in sub-saharan africa (ssa) is a particular challenge due to a combination of factors; limited resources and infrastructure, suboptimal diagnostics and a high prevalence of the major transfusion-transmissible infections (ttis). average seroprevalence data estimates from the ugandan and kenyan blood transfusion services (bts) for hepatitis c (hcv) currently stand at . % and . % respectively. between january and december , in mbale (eastern uganda) the hcv prevalence amongst blood donors was an alarming . %. with no provision or funds for confirmatory testing, the bts are unable to confirm or refute a diagnosis of active hcv. this results in large quantities of blood wastage, unnecessary anxiety in potential donors and high donor deferral rates limiting the donor pool. aims: we aim to determine the true prevalence of active hcv infection amongst seropositive donors in bts in uganda and kenya. in addition, we aim to compare the performance of locally used serodiagnostics and best available alternative tests and to examine the feasibility of cost-effective additional or alternative tests to help provide accurate results on the infectious status of blood. methods: hcv seropositive blood samples from bts study sites (kampala, mbale, mombasa) will be re-tested using the local serology screening test (abbott architect anti-hcv), an alternative who pre-qualified rapid antibody test (sd bioline) and a confirmatory test (hcv core antigen test). where there is discrepancy in the results or need for clarification, samples will be tested on the cepheid xpert platform by reverse-transcriptase pcr to obtain a quantitative rna result. s/co (specimen to cut-off) values for false positive samples (by screening serology) will be analysed and presented. pre-analytical factors (centrifugation speed, haemolysis check, time delay between collection and testing) will be controlled for and documented. results: pilot data from re-testing quarantined hcv seropositive donor blood (mbale bts) in uganda demonstrated that / seropositive blood ( %) was rna pcr negative. in december , / ( %) of seropositive samples (by screening anti-hcv serology) in kampala bts had s/co values between . - . ( . is the cut-off indicating a positive sample). data from the re-testing of seropositive samples as true representation of active hcv will be demonstrated and s/co values for the study period concomitantly with a retrospective analysis of january to december . preanalytical factors, cost analysis comparisons of the diagnostic platforms coupled with costs of the donor deferral process in false positive cases will be presented. summary/conclusions: for the bts in ssa there are significant resource and financial implications, as repeat testing and donor deferral counselling is required. evaluating and introducing new and appropriate diagnostics and algorithms in the screening of hcv is crucial in improving the supply of safe blood transfusion services in east africa. background: in november , the blood services of england, scotland and wales reduced donor deferral to three-months for commercial sex workers and individuals with higher risk sexual partners, including sex between men. the change was recommended after a detailed review by an external expert committee (sabto) which recommended that a shortened deferral of months would allow detection of recently acquired infection and maintain residual risk (rr) at a tolerable level. recommendations were accepted by government but with a government commitment to explore a more individualised approach. aims: to assess the impact of a -month deferral on blood safety in terms of epidemiology of infections in blood donors and compliance with donor selection criteria, and to explore evidence required to develop a more individualised approach to donor selection policy methods: routine uk blood donation surveillance data for - ( : preliminary) were reviewed. annual prevalence and incidence of hbv and hiv infection were estimated, with a poisson regression models to test for trends. incidence was calculated from donors seroconverting within -months, and/or microbiological and clinical evidence of recent infection. for donors positive in , compliance with the -month deferral was determined. uk hemovigilance data were scrutinised for evidence of transfusion transmitted infections (tti) associated with newly eligible donors. results: from to among new donors, annual hiv prevalence decreased significantly by an average of . % each year (p = . ) to . / , donations in ; no significant trend was observed for hbv. annual hiv incidence among repeat donors also decreased significantly by an average of . % each year (p = . ) to . / , -person years (pyrs) in (based on seroconverters). there was no significant trend in hbv incidence over the study period, however between and incidence increased from . / , pyrs to . / , /pyrs (based on and seroconverters respectively). with the information available to date, none of the seroconverting donors were non-compliant, and there was no reported confirmed ttis associated with the policy change. summary/conclusions: hiv prevalence and incidence has continued to decline. hbv incidence in repeat donors increased in although initial analysis suggests this is not associated with the policy change. monitoring continues, and residual risks will be re-estimated as data post-change accumulate. these data are reassuring, and therefore it is appropriate to scope the evidence for, and feasibility of, a more individualised approach to selection policy. a multidisciplinary steering group has been convened including representation from patient and stakeholder groups. gaps in knowledge are being defined, and a package of work is in development under the project of fair (for the assessment of individualised risk), using the abo rdf for guidance. background: permanent deferral of men who have sex with men (msm), established in the s, primarily to minimise the risk of hiv transfusion-transmitted infections is increasingly challenged. accordingly, blood services in many countries have changed to time-based deferral. in canada, a -year deferral was implemented in , reduced to -months in ; a -month deferral is now being considered. aims: to estimate the risk of undetected hiv among screened blood donations under a -month deferral since last sex between men. methods: the applied model combines features of previously published english and canadian models to estimate hiv risk under a -month deferral. three scenarios varying hiv incidence, prevalence and non-compliance under a -month deferral were modelled. assumed constants were the hiv nucleic acid window period, testing procedure error rate and assay sensitivity. model inputs were incidence under the current -month deferral, calculated as hiv positive donors with a previous negative within months divided by number of person years, numbers of hiv positive donations, hiv positive msm, hiv msm incident cases and newly eligible msm donors (from donor surveillance and compliance surveys). the risk with a -month deferral was estimated for three scenarios, one determined "most likely", where msm donor non-compliance, hiv incidence and hiv positive donations do not change and msm newly eligible to donate are estimated from compliance surveys. this scenario is based on data from two sequential policy changes in canada. an "optimistic" scenario where non-compliance halves and a "pessimistic" scenario where msm hiv incidence, hiv positive donations, non-compliance and new msm donors double were also used. the median hiv residual risk was used as the final estimate. the uncertainty in this estimate was assessed with the . th and . th percentiles over the simulation ( % ci). results: incidence, per , donations, was estimated to be . , . and . for the "most likely" "optimistic" and "pessimistic" scenarios, respectively. for the month deferral "most likely" scenario, hiv residual risk was predicted to be in . million donations ( % ci: in , million to in . million). for the "optimistic" scenario, hiv residual risk was estimated to be in . million donations ( % ci: in , million to in . million). finally, for the "pessimistic" scenario, hiv residual risk was estimated to be in . million donations ( % ci: in , million to in . million). with these residual risk estimates, based on the number of donations in canada, one hiv infectious donation would be in inventory every years for the "most likely" scenario, every years for the "optimistic" scenario and every years for the "pessimistic" scenario. summary/conclusions: the risks of hiv entering the blood supply in canada for a -month msm deferral are predicted to be very low for all modelled scenarios, including a "pessimistic" doubling of hiv incidence post change. background: safety of blood and blood products is a major concern in pakistan. the prevalence of transfusion transmitted infections among multi-transfused thalassaemia patients is high (above %). the hiv epidemic in pakistan is following the asian epidemic model where after establishment among the high risk groups, its transmission to general public is rapid. fear, stigma and ignorance have contributed heavily to hiv transmission in pakistan. the hiv detection among blood donors is on the rise and reports occur in media repeatedly. aims: to investigate the possible transmission of hiv through blood transfusion in punjab, pakistan and to highlight the steps being taken to reduce further transmission of infections methods: in september , a report of hiv transmission through blood transfusion was reported in the media where a mother and her newborn acquired hiv after blood transfusion from a hiv positive donor (confirmed later). the case was referred to and investigated by the punjab blood transfusion authority (pbta). the pbta team took blood samples of both recipients (mother and her newborn) and the blood donor who was a family relative. the samples were tested by highly sensitive chemiluminescence immunoassay (clia). the clia results confirmed the presence of hiv in both recipients and the blood donor. due to maternal hiv antibodies transfer through the placenta, the infection status of the newborn was not re-confirmed as he died within two weeks. the donor informed that he had donated times in the past few years. the pbta was able to trace only one earlier donation three months ago. the recipient (a female) was found, tested by clia and was found to be hiv positive. all these cases occurred in unlicensed private blood banks that were screening for hiv on rapid manual devices. the blood banks were sealed by the authority and infected cases were registered by the provincial aids control programme and are being treated. summary/conclusions: the main reasons for hiv spread through blood transfusion is the use of sub-standard rapid screening devices which are not evaluated and validated at a national level. in addition, the existing system relies on the family/replacement donors. the national safe blood transfusion programme, is implementing blood safety system reforms as recommended by who. under the reform agenda, the blood transfusion authorities have been made functional and grant licenses to only those blood banks with proper systems to ensure quality and safety of blood products. the programme is developing a national system for the evaluation, selection and validation of all assays used for screening of blood in close coordination with the drug regulatory authority of pakistan. to promote the culture of voluntary blood donations, the programme has taken concrete steps initiating with the formulation of a national blood donor policy, interaction with celebrities, celebration of world blood donor day and more recently the launch of blood donation feature through 'facebook'. the promotion of voluntary blood donation concept along with regulation of blood sector will reduce the risk of hiv transmission through blood transfusions in pakistan. mianyang blood center, mianyang urumqi blood center, urumqi, china rti international, rockville national heart, lung, and blood institute, bethesda stanford university, stanford, united states background: the incidence of hiv infections has increased substantially over the past decade in china, especially among young people, who represent nearly half of the chinese blood donor population. this upward trend in hiv infections underscores the importance of monitoring hiv prevalence and incidence in chinese blood donors. aims: to estimate hiv prevalence and incidence rate (ir) among chinese blood donors using blood donation data from five geographically-disperse blood centers in - participating in the recipient epidemiology and donor evaluation study-iii (reds-iii) china program. methods: western blot confirmatory testing was done on samples of blood donations reactive for hiv- / on one or both rounds of routine elisa tests or positive by nucleic acid amplification testing (nat). multiple imputation was used for samples with missing confirmatory test results. hiv prevalence was calculated among first-time donors. to estimate hiv ir in first-time donors, single-well lag-avidity eia testing was conducted with first-time hiv recent (incident) infections defined as being infected within approximately days based on avidity of hiv antibodies. a novel model was derived to estimate hiv ir among infrequent repeat donors who had provided only one donation in the - estimation interval. to derive an overall hiv ir for repeat donors, this estimate was combined with the classical-model ir estimated for repeat donors who had given at least donations in the estimation interval. multivariable logistic regression model was used to examine factors associated with hiv infection. results: a total of , , whole blood and apheresis platelet donations with postdonation screening results were collected at the five blood centers between and , including , donations from first-time donors and , donations from repeat donors. hiv prevalence among first-time donors was . per , donors ( % ci, . - . ). hiv ir was estimated to be . per , person-years ( % ci, . - . ) among first-time donors and . per , person-years ( % ci, . - . ) among repeat donors. hiv prevalence and ir varied across regions with an increasing trend observed at some blood centers. among first-time donors, being male, older than years, minority ethnicity, less than college education, and certain occupations (commercial services, factory workers, retired, unemployed, or self-employed) were associated with positive hiv confirmatory testing results. summary/conclusions: although hiv prevalence and incidence remain low among chinese blood donors, it is important to monitor hiv epidemiology in blood donors on a continuous basis, especially among populations and regions of higher risk. further donor screening and education strategies need to be developed and evaluated to reduce these risks. the ir methods used in this study for first time donors as well as repeat donors who donate very infrequently is readily applicable to other countries who have similar donation patterns. background: in thailand, the national blood centre is responsible for blood donation service which includes follow-up and blood donor counseling in order to indicate the infection status, especially hiv-positive blood donors. currently, although the epidemic of hiv infection in thailand is in decline, the hiv-positive cases still have been found in blood donors screening. thus, monitoring of hiv infection status in blood donors and post-blood donor counseling are important for providing the hiv-positive infected donors lead to access the hiv treatment immediately. aims: to study the hiv follow-up cases on serological testing over years for assessment of the hiv infection in thai blood donors. the retrospective analysis of hiv follow-up cases on serological testing (cmia, ics and western blot) was conducted during to at thai national blood centre. results: a total of , , voluntary blood donations over years, the repeated reactive results on hiv serological screening were , ( . %) cases and only half of these hiv reactive donors returned to follow-up testing for ascertaining their hiv status. for hiv follow-up process, the hiv reactive screening donors must be followed for months and tested by using the different three principles of hiv serological testing. a total of , hiv reactive results were separated to three patterns including hiv positive results, inconclusive results and negative results which the number of each group was , ( . %) cases, ( . %) cases and , ( . %) cases respectively. out of , hiv positive results, we found that , ( . %) cases were positive with all hiv serological testing for the first-time follow-up and ( . %) cases were tested and become to positive results after follow-up more than one time. in cases of inconclusive results, ( . %) cases were reactive only or testing(s) which these donors did not return to confirm again leading to temporarily deferred donors in blood donor system. in addition, ( . %) cases of inconclusive results could not conclude the hiv result although they were repeated several times. for the last pattern, , negative results cases showed ( . %) cases were negative results after follow-up over months while ( . %) cases were inconclusive results before changing to negative results which almost cases of this group were reentry as blood donor after deferral period is over. summary/conclusions: the number of repeated reactive results on hiv screening was constant over years of which returned to follow-up only half of hiv reactive donors leading to accumulation of temporarily deferred donors in blood donation system. hiv follow-up positive cases were informed and counseled immediately then referring to anonymous clinic for treatment. the problem and challenges of hiv follow-up were inconclusive results that were unclear and some of these did not return to retest lead to loss of re-entry donor who might be changed to negative result afterward. hence, the effective counseling and follow-up system need to be taken urgently to encourage the temporarily deferral donors returned to retest for reducing stigma of deferred donors in hiv follow-up cases. . we only analyzed the information that had non-reactive results for infectious markers reported by blood banks to sihevi-ins©, because they represent a risk for blood recipients. results: when loading the information of sivigila in sihevi-ins©, donors were found ( % men); of these people donations were obtained ( % whole blood). donors ( %) had a reactive result for hiv being subsequently reported in sivigila. in addition, five of them were reactive simultaneously for hbv in blood banks and took on average ae days to be reported in sivigila. donors ( . %) had an hiv reactive result notified by sivigila and subsequently they were reactive in blood banks. this behavior may suggest an attempt to spread the disease. donors ( % men) despite being initially reported in the sivigila database, presented a non-reactive result in a blood bank for hiv; one of them was reactive for syphilis and hbv and only one for hbv. this pattern may suggest false positive or negative results in one of the two databases analyzed. fourteen donors had negative test in blood banks for hiv and in a range of up to months they were reactive by sivigila ( % of them donate whole blood). this conduct may suggest that accepted donations were in a window period and therefore warrant further investigation. considering that two blood components could be obtained on average from each donor, a potential risk is estimated for recipients. summary/conclusions: the donors reported first in the blood banks through sihevi-ins© and later in sivigila allow to estimate an adequate orientation to the health services. the information from general epidemiological surveillance programs could improve the selection of donors and transfusion safety. background: it is assumed that bacterial contamination of blood products most often takes place during the donation process. the number of bacteria at this time point is estimated to be around - cfu per bag. little is known about the growth behavior of different bacteria species in whole blood (wb) units during storage and the distribution of bacteria to the different blood products. aims: aim of the current study was to determine the growth of different bacteria species in contaminated wb units and to study the distribution of the bacteria to the different blood components. methods: whole blood (n = - per species) was inoculated with approximately cfu of different bacteria species (escherichia coli, klebsiella pneumoniae, pseudomonas fluorescens, staphylococcus aureus, staphylococcus epidermidis, streptococcus dysgalactiae, streptococcus pyogenes) and stored for to h at room temperature before centrifugation and separation into red blood cells (rbc), buffy coat (bc) and plasma. bcs from spiked wb were each pooled with random bcs to prepare plasmareduced platelet concentrates (pc). samples were taken from wb after storage and from the blood products (rbc, bc, plasma and pc) right after preparation, and the bacterial titer was determined. sterility of pcs was tested by bact/alert after seven days of storage. results: bacterial growth in wb varied remarkably between donations and bacteria species. the highest titers in wb were detected for the streptococcus species, whereas staphylococcus aureus, staphylococcus epidermidis, escherichia coli and pseudomonas fluorescens did not multiply. bacteria preferably accumulated in the bcs during separation, reaching titers of up to . cfu/ml in bcs and up to . cfu/ml in the corresponding pcs right after preparation. in total, out of pcs tested positive for bacteria at the end of storage. the results were dependent on the species used: e.g., / pcs tested positive after spiking with streptococcus pyogenes, while only / pcs tested positive after spiking with escherichia coli. bacterial contamination of rbc and plasma units was much less frequent and associated with higher bacterial titers in the parental wb units. summary/conclusions: the growth and distribution of bacteria during processing of wb into the different blood products is species-dependent and remarkably varies between donations. results: both patients were male ( yo and yo) with a history of acute myelogenous leukemia status-post haploidentical stem cell transplant. the patients were thrombocytopenic and underwent simultaneous transfusion of irradiated, non-pr, day platelets stored in platelet additive solution, from a single apheresis collection. the blood supplier's primary pre-release bacterial cultures were negative, and the on-site point of release secondary safety measure pan genera detection (pgd) testing was negative for both gram positive (gp) and gram negative (gn) organisms. both apheresis units also passed visual inspection prior to release from the blood bank. during transfusion, both patients displayed signs of septic transfusion reaction including rigors, fever, hypoxemia, tachypnea, tachycardia, and hypotension. transfusion reaction evaluations were initiated, and both patients were admitted to the medical intensive care unit and started on broad-spectrum antibiotics. gram stain of one platelet unit demonstrated gram negative rods (gnr) and gram positive cocci (gpc) in clusters, and the second platelet unit demonstrated gnr only. repeat secondary safety measure pgd testing of both units was negative for both gp and gn organisms. direct bacterial cultures of both platelet units grew both gnr and gpc identified as a. baumanii and s. saprophyticus after h of incubation. colonies on the initial bacterial plates were too numerous to count (tntc), and subsequent re-plating of the platelet units showed: unit : a. baumanii tntc and s. saprophyticus with . cfu/ml unit : a. baumanii . cfu/ml and s. saprophyticus . cfu/ml blood cultures collected from both patients became positive within h with gnr on gram stain, and both blood cultures ultimately grew both a. baumanii and s. saprophyticus. the primary pre-release cultures at the blood supplier remained negative. after days on antibiotics and pressors, both patients stabilized and were discharged home. the blood donor was interviewed, and he was well. no cultures were collected. summary/conclusions: this case documents failure of both primary pre-release bacterial testing and secondary on-site point of release pgd testing to identify two pathogenic organisms. a. baumanii and s. saprophyticus are unusual causes of septic transfusion reactions, and it is possible that these organisms have different limits of detection in the pgd assay compared to other organisms. rapid attention to clinical signs during transfusion and prompt initiation of antibiotics is critical for the management of septic transfusion reactions. we are currently evaluating ways to further reduce septic transfusion reactions, including increasing the utilization of pathogen reduced platelets. background: transfusion-associated infections due to the transmission of bacteria still represents a major risk in developed countries nowadays. despite the refrigerated storage of red blood cells (rbc), fatal reactions of patients receiving contaminated rbc units are repeatedly reported. in order to further increase the safety of blood transfusions, new strategies and measures have to be developed. in this context, transfusion-relevant bacteria reference strains can serve as a valuable tool for the validation, comparison and interpretation of these new developments. aims: conducting a collaborative study to establish the first repository for red blood cell transfusion-relevant bacteria reference strains. methods: six bacterial strains (serratia liquefaciens, serratia marcescens, pseudomonas fluorescens, listeria monocytogenes, yersinia enterocolitica a- and yersinia enterocolitica a- ) were distributed from the paul-ehrlich-institut to laboratories in countries for enumeration, identification and growth measurement in a -day interval for a total of days after low-count spiking of rbc bags ( - colony-forming units (cfu)/rbc bag). results: except for s. marcescens, all other strains showed good-to-excellent growth in rbc. s. liquefaciens, p. fluorescens, y. enterocolitica a- and y. enterocolitica a- achieved > cfu/ml at day and cfu/ml at day . growth of l. monocytogenes was lower reaching a maximum concentration of > cfu/ml at day . in out of laboratories, s. marcescens showed no growth at all. summary/conclusions: five of the six tested strains showed robust growth in rbc independent of donor variability and are promising candidates to be adopted as official rbc transfusion-relevant reference strains by the world health organization. background: the samplok sampling kit (ssk), itl biomedical, is used by nhs blood and transplant (nhsbt) for sampling of platelet components (pc) for bacterial screening using the bact/alert d system. inoculation of bact/alert bottles is performed immediately after sampling. validation of delayed inoculation, with retention of the sample within the ssk devices, would allow a contingency for transport to other screening sites in the event of an incident that prevented testing at the sampling site. ssk maintain a closed system for sampling of pc and are compatible with standard blood collection bags. a graduated chamber ( or ml) ensures that only the required sample volume is collected and an integrated needle allows inoculation into bact/alert bottles. aims: the national bacteriology laboratory, nhsbt, evaluated the impact of prolonged storage of pc samples in ssk devices with regard to bacterial viability and detection. methods: four reference species were assessed: staphylococcus aureus (atcc ), streptococcus agalactiae (atcc ), escherichia coli (atcc ), clostridium perfringens (atcc ). a pool and split method was used with apheresis pc suspended in plasma. units were screened using bact/alert d prior to spiking to prove the absence of contamination. pc were spiked with a single species (range - . cfu/ml) and tested on bact/alert with a ml inoculation into anaerobic and aerobic bottles (positive control). enumeration was performed to confirm the bacterial concentration. each unit was sampled using two ml ssk, which were held for a period of h at - °c. the process was repeated with a -h period. once elapsed, ml of each ssk was inoculated into an aerobic and anaerobic bact/alert bottle, one ssk per atmosphere per species and the remaining sample was enumerated. all bottles were incubated on the bact/ alert system for a maximum of days ( ae . °c) and subcultured if positive. results: positive controls had detectable growth by bact/alert, excluding aerobic bottles with c. perfringens. this was expected as it is an anaerobic organism. after the storage periods, all bottles had detectable growth by bact/alert. s. aureus showed an increase of . -log after h ( . to . cfu/ml) and . -log after h ( . cfu/ml to . cfu/ml). s. agalactiae increased by . -log after h ( . cfu/ml to . cfu/ml) and . -log after h ( . cfu/ml to . cfu/ml). c perfringens increased by . -log after h ( . cfu/ml to . cfu/ml) and . -log after h ( . cfu/ml and . cfu/ml). for e. coli, the concentration after h was reduced by . -log ( . cfu/ml and . cfu/ml), however this was possibly a result of inherent counting errors. at h, an increase in growth by . -log ( . to . cfu/ml) was obtained. summary/conclusions: storage of pc samples in ssk devices for up to h does not have a negative effect on bacterial viability and detection using the bact/alert d system. background: the intercept tm blood system for platelets efficiently inactivates pathogens and leukocytes in platelet concentrates (pc). the system utilizes amotosalen and uva light and is available for the treatment of apheresis and whole blood (wb) derived platelets (mostly buffy coat pools) in europe in plasma or platelet additive solution (pas), and the treatment of apheresis platelets in the us (trima tm in % plasma or amicus tm for % intersol pas/ % plasma). acinetobacter baumanii and staphylococcus saprophyticus strains were isolated from a saline flush taken h after successful and complete transfusion of an apheresis intercept-treated pc in % pas/ % plasma, from a patient with a suspected septic reaction that occurred h post transfusion. bacterial isolates, and a sample of a gram stain-negative and culture-negative sister split pc were submitted for evaluation. we report here the in vitro inactivation of the fast growing, gram negative bacterium a. baumanii and slower growing gram positive s. saprophyticus. the sister unit was assessed for amotosalen break down products as an indication of successful inter-cept treatment. aims: the objective of the study was to evaluate bacterial inactivation of a. baumanii and s. saprophyticus in apheresis platelets, assessed immediately after treatment and with re-culture at the end of a day shelf-life. methods: a double apheresis pc collected in % pas/ % plasma was split into three equal components, yielding approximately ml of platelets/pc. a. baumanii and s. saprophyticus were grown in lb broth and each pc unit was inoculated with either bacterial strain or the combination of both strains, each at~ log colony forming units/ml (cfu/ml). after inoculation, the contaminated units were treated in small volume (sv) intercept kits. samples were taken: pre and post-inactivation treatment, and at , and days of storage. the samples were analyzed by plating on lb plates ( ll- ml). residual amotosalen levels were assessed by hplc. results: initial bacterial titers were . - . cfu/ml. following the inactivation treatment, no viable bacteria were detected by plate culture. no bacteria were detected after , and days of storage, corresponding to > . log inactivation of both bacterial strains. performance of the intercept treatment process was confirmed in the sister pc unit as evidenced by levels of amotosalen and its byproducts characteristic of intercept treatment, as well as by review of the process documentation. summary/conclusions: amotosalen/uva effectively inactivated a. baumanii and s. saprophyticus individually and together below the limit of detection after days storage. no bacteria in the sister pc by gram stain and culture, and the presence of amotosalen byproducts suggested that the pc collection involved in the septic reaction was sterile at the time of intercept treatment and was successfully illuminated. the possibility of only one-of-two split pc being contaminated due to biofilm formation is minimized in the intercept system which decants platelets into virgin storage bags at the end of treatment. contamination of the source pc container likely occurred after intercept treatment, possibly at the time of spiking for transfusion. background: studies in sub-saharan africa have documented bacterial contamination of blood products for transfusion varying between , %> , %, up to times higher than in the north. published data from central africa are lacking. aims: the aim of this study was to determine the proportion of blood products contaminated with bacteria in three hospitals in the democratic republic of the congo (drc). to assure aseptic sampling, we used a closed system of sampling bags. in addition to the presence of contamination, we assessed semi-quantitative colony counts. methods: from july to december , a total of blood products were sampled, of which in hôpital provincial g en eral de r ef erence, kinshasa (hpgrk), in hôpital p ediatrique kalembe lembe, kinshasa (hpkll) and in hôpital saint-luc, kisantu (hslk). after compatibilization of blood products, ml of blood was transferred from the primary blood bag to an attached sampling bag. sampling bags were sealed off, stored in the fridge and transported once daily to the bacteriology laboratory. using the adapter connected to the sampling bag, ml of blood was inoculated in a blood culture (bactalertpf, biom erieux) and incubated at °c for days. cultures were checked daily for signs of growth. in addition, ml of blood was equally distributed on the cled and macconkey agar-coated sides of a dipslide (meus s.r.l.). dipslides were incubated h for semi-quantitative culture, expressed as colony-formingunits (cfu) per ml. in case of blood culture growth, bacteria were identified and a second blood culture was inoculated to exclude contamination during processing. bacteria grown on semi-quantitative culture were also identified. results: a total of . % ( / ) of whole blood and red cell concentrates were contaminated with bacteria. in hpgrk, . % ( / ) of blood products were contaminated, in hpkll . % ( / ) and in hslk . % ( / ) . the proportion of contaminated blood products was significantly higher in hpgrk compared to hslk (p = . ). there was no significant difference between the other sites (p = . and p = . ). majority of isolated bacterial species were coagulase-negative staphylococcus spp./micrococcus spp. ( . %) and bacillus spp. ( . %). the remaining % of bacterial isolates were identified as non-fermentative gram-negative rods, klebsiella pneumoniae, staphylococcus aureus, mould, listeria spp., corynebacterium spp./coryneform bacteria. the concentration of all isolated bacteria was lower than ³ cfu/ml, except for one coagulase-negative staphylococcus spp. found in hpgrk at ³ cfu/ml. summary/conclusions: to our knowledge, we were the first to reach a sample size of more than blood products for bacterial culture and the first to use a closed system of sampling bags in sub-saharan africa, which guarantees aseptic sampling of blood cultures. this might explain the low bacterial contamination rate ( . %) of blood products in three hospitals in drc compared to previous studies in other sub-saharan african countries. moreover, bacterial concentrations in the contaminated blood products were low (< ³ cfu/ml). the different proportions of contamination between study sites suggest that different environments and practices play a role in the risk for bacterial contamination. background: although the screening of the treponema pallidum (tp) is mandatory in blood donations, its necessity is controversial, because there have been no transmissions by blood products documented in the developed countries in the last few decades. aims: based on laboratory markers, active and early tp infected donors (aeid) were determined. the demographics of aeid and the frequency measures of cases were compared with that of early infected syphilis cases (syc) notified from the to -year-old general population registered at the nphc. methods: altogether, , to -year-old donors were screened with anti-tp immunoassay (architect syphilis tp, abbott, wiesbaden, germany) between and . reactive results were confirmed with immunoblots (viramed biotech ag, planegg, germany), which discriminated both specific anti-tp (igg, igm) and non-specific vdrl antibodies in five dilutions. meeting the criteria of anti-tp igg positivity with a vdrl titer of ≥ : and anti-tp igm positivity, donors were considered as aeid. they were stratified by age, gender and residence regions. the proportion of aeid (paeid) and syc (psyc) were calculated in first time (ft), and repeat tested (rt) donors and in the to -year-old general population, respectively, in each year studied. the period prevalence (pp) of aeid and syc was estimated in the populations at risk , across - . statistics: weighted proportions and one-way anova with tukey post-hoc test and z score test were applied. statistical significance was defined as p < . . results: anti-tp reactivity was confirmed in blood donors. aeid was proved in cases with ft and rt donors. in that period, syc were notified. both in aeid and syc, the age group of - years with approximately % and % of individuals was the dominant. the proportion of men was % and % (p = . ) in the aeid and syc, respectively. paeid estimated in ft donors was significantly higher ( . %; . %; . %, p < . ) than that of rt donors ( . %; . %; . %) and the proportion of syc ( . %; . %; . %) in the general population. pp of aeid showed a roughly homogenous distribution in the regions ( . %- . %), however, pp of syc had a significant ( . %; p < . ) central hungary dominance in relation to the other regions ( . %- . %). comparing the pp of aeid to syc, central hungary indicated a significant difference ( . % vs. . %, p < . ), however, other regions showed no substantial differences. summary/conclusions: donors with anti-tp confirmed positivity are referred to the healthcare system. based on the laboratory markers tested, aeid could be separated and their demographical characteristics are pretty similar to that of syc notified from the general hungarian population. the proportion of early and active infection in ft donors is significantly higher than that of rt donors and the proportion of syc in the general population. given the considerable number of tp infection in background: quality assurance and safety of hematopoietic stem cells (hsc) with emphasis on prevention of bacterial and fungal contamination are the prerequisites for any transplantation procedure. bacterial contamination is of particular significance as it occurs relatively more frequently and bacteria are gradually gaining more antimicrobial resistance. aims: the aim was to determine the incidence rate of bacterial and fungal contamination during processing of transplantation material at the institute of hematology and transfusion medicine (ihtm) taking into account the hsc sourceperipheral blood (pbsc), bone marrow (bm) or cord blood (cb). methods: analysis involved both autologous and allogenic components collected at ihtm and other hospitals and dedicated for ihtm patients. in all, the analysis comprised donations, including bm ( . %), pbsc ( . %) and cb ( . %) donations processed in our laboratory in the years - . bm was collected in operating theatre-conditions, pbsc with cell separators -cs- (baxter), cobe spectra (gambro) and trima accel (terumo bct) and cb was acquired from umbilical vein at obstetrics and gynaecology wards. aerobic and anaerobic bacteria contamination was determined at various incubation temperatures (room temperature and °c) using a variety of culture media. pbsc and bm were tested using samples with trypcase-soy broth (tsb-t) and with schaedler + vit k (biomerieux). cb was tested using bactec peds plus/f and bactec lytic/ /anaerobic/f (becton-dickinson). results: in the - period contaminated products were found: pbsc ( . % of all tested pbsc units) and cb ( . % of all tested cb units). no infected bm products were determined. the overall percentage of contaminated products was estimated at , %. in , three ( ) products were found contaminated with staphylococcus epidermidis; all came from one patient with central venous catheter and were collected on consecutive days. other products were contaminated mostly with staphylococcus epidermidis ( . %). detailed results to be presented on the poster. summary/conclusions: according to ihtm policy no contaminated product is admitted to clinical use. the outcome of our study identifies processing experience of the staff as the main indicator of product quality. important is also proper assessment of donor health and condition of the injection site as products are usually collected from central venous catheter. the closed system is an additional safeguard against contamination during processing. the sample collecting procedure should help to avoid false positive results. background: syphilis is considered a global public health problem. the world health organization (who) estimates that there are annually around million new cases of syphilis in the world, more than % occurring in developing countries. despite significant decrease in syphilis transfusion transmission. the recent increase in worldwide incidence associated with the risk of transmission through platelet concentrates (cp), which are stored at room temperature, have called attention to the potential residual risk of syphilis transmission by transfusion. between and we observed in our institution a significant increase of % in positivity of syphilis among blood donors from . % in to . % in and . % in (p < . ). aims: to determine the prevalence of active syphilis in blood donors and characterize the serological profile of syphilis positive donors. methods: each positive sample in a treponemic chemiluminescence assay (cmia, abbott architect) performed during blood donor screening in was submitted to a treponemic elisa anti-treponema pallidum igm (euroimmun) and a non-treponemic test (antigen-omega diagnostics). samples with positive results for one or two of these tests (indicating recent syphilis) were submitted to a real-time pcr for syphilis. the inno-lia syphilis-fujirebio immunoblot test was also performed for samples that presented a positive result for elisa-igm alone. financial support: fapesp / - . results: among , samples screened in , ( . %) presented a positive result for cmia -syphilis. of these, ( . %) were included in the study. a total of samples ( %) showed vdrl+/igm+; ( %) vdrl+/igmand ( . %) vdrl -/elisa igm+. the inno-lia syphilis test was performed as a confirmatory test in ( . %) samples that presented positive results for elisa igm and vdrl negative with ( . %) positive results, ( . %) undetermined and ( . %) negative. none of the samples showed the presence of treponema dna by real-time pcr. the prevalence was . %, the incidence was . % in the year , and the incidence in relation to the total positivity was . %. both, prevalence and incidence were higher in men, white, not married, aging - years and high school educational level. we observed a % a-hbc seroprevalence in the elisa igm-syphilis positive samples and a prevalence of . % htlv coinfection. summary/conclusions: we observed a significant increase in prevalence of syphilis in ( . %) with an incidence of . % of the total of cases initially positive in the cmia test. according to our data, we could identify a risk of syphilis transfusion transmission in blood banks that exclusively use the vdrl for donor screening, once we found ( . %) cases with negative vdrl and elisa igm and inno-lia positive. continuous monitoring of the profile of donors infected with syphilis at this time of reemergence of the disease is useful and important not just for blood banks, as it reflects the epidemiological situation of disease in community, and can contribute to the definition of health policies. background: transfusion related sepsis is a serious concern limiting platelet storage time to days at room temperature. while most units are screened for bacterial contamination when collected, bacterial monitoring methods can take up to days to detect contamination. thus, cold storage of platelets represents an attractive alternative for improving platelet safety. in this study, we assessed bacterial growth in platelets stored either at room-temperature (rt; °c) or refrigerated (cs; °c). aims: the aims of this study were to ) assess the effect of storage temperature on platelet function and bacterial growth in "contaminated" platelet units, and ) identify factors contributing to bacterial growth during rt storage. methods: apheresis platelets in plasma (plt) were obtained from healthy donors using the terumo trima accel automated blood collection system (terumo bct). fresh plasma (fp) was collected similarly. aliquots of plt or fp were transferred to ph safe minibags (blood cell storage, inc) and "contaminated" with acinetobacter baumannii, escherichia coli, pseudomonas aeruginosa, staphylococcus aureus, staphylococcus epidermidis, or pbs (uninfected control). minibags stored at rt were agitated using an orbital shaker set to rpm while cs aliquots were stored under static conditions. bacterial growth was monitored daily through dilution plating. lactate levels were assessed by istat (abbott) cg + test cartridges. plasma glucose levels were assessed using blood glucose testing strips (germaine laboratories). platelet activation and aggregation were assessed on days , , , and by flow cytometry and multiplate platelet aggregometry, respectively. results: bacterial growth progressed rapidly over the first - days post-collection in all plt aliquots stored at rt except those challenged with s. epidermidis. significant growth of s. epidermidis was not detected until day . bacterial numbers remained unchanged in refrigerated aliquots through day . rt storage resulted in significantly (p < . ) decreased platelet aggregation over time which was exacerbated by bacterial challenge. plt function was largely preserved with refrigeration regardless of challenge. bacterial growth was significantly reduced, or at least delayed, in fp. fp challenged with gram-negative pathogens exhibited a significant (p < . ) delay in bacterial growth at day . while growth of e. coli and p. aeruginosa recovered by day , growth of a. baumannii was significantly (p < . ) inhibited throughout. fp challenged with gram-positive pathogens exhibited significant (p < . ) reduction in bacterial growth relative to plt aliquots. bacterial growth correlated with plt lactate production. lactate levels in plts challenged with e. coli showed diminished significantly after day , indicative of lactate utilization. with exception of fp challenged with s. aureus, bacterial growth was restored in fp supplemented with lactic acid in all challenge groups. summary/conclusions: refrigeration preserved platelet function while both inhibiting bacterial growth and lactate production. conversely, the opposite was observed with rt storage. these data demonstrate that bacterial growth can be controlled through refrigeration without loss of function and rt storage may potentiate growth of certain bacterial strains through accelerated plt metabolism. background: bacterial contamination of peripheral blood progenitor cell (pbpc) for transfusion has been the cause of serious sepsis and life-threatening infections. however, a standard procedure or choice of test sample(s) has not been established to screen pbpc products for microbial contamination, because these products are not large enough to facilitate inoculation of the recommended volume for the automated blood culture systems. samples taken from by-product plasma and low volume pbpc product were cultured in routine sterility test. aims: to evaluate the residual risk of microbial contamination in pbpc products for transplantation, we cultured sufficient post-thaw inoculation volumes from pbpc products which were discarded for various reasons in our blood center. methods: in routine sterility test, a -ml sample of by-product plasma collected with pbpc product was inoculated into bact/alert bpa and bpn culture bottle ( ml each) within h after collection. the bottles were then placed in the bact/ alert system and incubated for at least days or when a positive reaction was indicated by the automated liquid-media culture system. moreover, a -ml postthaw sample would be cultured before transplantation performed. in the residual risk investigation, discarded pbpc products were thawed, and then a -ml and a -ml aliquot were taken and cultured with the same method. all positive bottles were subcultured for bacterial isolation and identification. results: in september and march , after maintaining in liquid nitrogen for to years, pbpc products collected from patients, which was preserved in a volume between and ml, were discarded. all of these products had been cultured negative in routine sterility tests with plasma samples. these final products were thawed and cultured with both the -ml and the -ml aliquot. one of these pbpc products had the positive culture result with the -ml retested samples. nevertheless, the same pbpc product had the negative result with the -ml post-thaw pbpc sample and the -ml by-product plasma sample. propionibacterium acnes was isolated from the bpn positive bottle. summary/conclusions: the residual risk of microbial contamination in pbpc postthaw products still exist after routine sterility test with the plasma sample and the -ml volume of pbpc sample. the bacterium isolated from pbpc product was normal skin flora bacterium. an optimal screening method of pbpc products merits further study to increase the safety of the blood supply. background: hospital hygiene tools that serve as a proxy for assessment of microbial contamination are increasingly used. they include adenosine triphosphate (atp) bioluminescence and air particle counting. however, their use for microbial monitoring of blood banks remains underexplored. they could be of particular interest in a sub-saharan african setting (temperatures, dust) to circumvent bacterial culture and provide direct results usable for monitoring over time. aims: the aim of this study was (i) to quantify environmental bacteria in the air and on surfaces that are regularly in contact with blood products, and (ii) to evaluate atp bioluminescence techniques and particle counts as a predictor for bacterial contamination, in three blood banks in the democratic republic of the congo (drc). methods: samples were taken in three blood banks in the democratic republic of the congo: hôpital p ediatrique de kalembelembe (hpkll) ( surfaces, air), hôpital provincial g en eral de r ef erence (hpgrk) ( surfaces, air) and the national blood transfusion centre (cnts) ( surfaces, air). surfaces that are regularly in contact with blood products were selected (sealer, fridge, donor chair,. . ..). regular surfaces were sampled using rodac contact plates ( . cm²) containing cled and macconkey agar, irregular surfaces using swabs (nrsii, medicalwire). atp was measured on the same surface (pd , kikkoman), expressed as relative light units (rlu) per cm². air was sampled by active sampling ( liter; spinair, iul) on cled and macconkey medium. in parallel, particles > . lm and > lm were counted using a particle counter ( , liter; metone a). culture media were incubated for h at °c before counting colony forming units (cfu). results: for regular surfaces, the median (range) viable bacterial count was ( - ) cfu/rodac, ( - ) cfu/rodac, ( - ) cfu/rodac for hpkll, cnts and hpgrk, respectively. at hpkll, highest viable counts were found in the sink (plain growth) and cool boxes ( and cfu/rodac). in cnts the blood processing bench, the donor chair arm support and washing basin showed the highest counts (plain growth). whereas in hpgrk, most bacteria were found in a fridge (plain growth), blood bag trolley (plain growth) and manual separator ( cfu/ rodac). gram-negative bacilli were isolated from water basins and sink in cnts and hpkll, but also surfaces close to donor chairs at hpgrk. the median (range) of atp per cm² was . ( - . ) rlu at hpkll, ) rlu at cnts and . ( . - . ) at hpgrk. atp results and total viable count were not correlated (n = , p = . ). median (range) bacterial count in the air was ( - ) cfu/ l for all sites together. there was no correlation found between total bacterial count and particles > . lm or > lm (r = . and r = . respectively; p < . ; n = ) summary/conclusions: total viable bacterial count of surfaces varies over blood bank sites. according to our results, atp and particle counts did not correlate with bacterial counts on surfaces and in the air, respectively. bacterial isolates from blood bank environments in drc need to be identified and seasonal variations need to be evaluated. background: the risk of transfusion-transmitted hepatitis e virus (tt-hev) infections in line with the question of the necessity of hev-nat screening of blood products is currently subject to an ongoing debate on the importance of timely introduction of hev screening of blood donors and the impact of blood safety. different countries have chosen different regulatory approaches. just recently, the german federal authorities have introduced mandatory testing of all therapeutic blood products beginning from january st . however, we already decided to voluntarily test all our blood products since january . aims: in this study, we present our results of a % screening of therapeutic blood products for hev rna including four years of active surveillance of hepatitis e infection among blood donors in germany. methods: from january to december , a total of , allogenic blood donations from , individual german blood donors were screened in a minipool format of samples of for the presence of hev rna (realstar hev rt-pcr kit, altona diagnostic technologies (adt), hamburg, germany). nucleic acids were extracted from . ml plasma using the chemagen msm-i extractor (viral k, perkin elmer chemagen gmbh). the % lod of the assay was determined to . iu/ml ( iu/ml per single donation). the presence of hev-specific igm and igg antibodies was determined using the anti-hev igm/igg elisa (euroimmun, luebeck). hev rna concentrations were quantified using the first who international standard for hepatitis e virus rna for nat-based assays. all hev rna positive donors were deferred from donation for months. follow-up samples were tested for the presence of hev rna and hev-specific antibodies. genotyping was performed by sequencing of the hypervariable region (hvr) and orf . results: in total, hev rna positive donors were identified. of these, hev rna-positive donors, were nat-only positive donations ( . %, negative for anti-hev igm and anti-hev igg), three donors had a positive igm titer ( . %), donors showed reactive igm and igg titers ( . %), donors already had isolated igg titers ( . %). median values of viral loads were approximately twice as high in index donations that were antibody negative. merely donors showed elevated alt levels ( . %), mostly within a double increase within the reference range ( . %), only . % of donors had even further elevated alt levels. significantly higher alt values were found in donors with a viral load > , iu/ml compared to the group with viral loads between and iu/ml. available follow-up samples confirmed igg seroconversion for all donors, however we also observed long-term igm positivity in some donors. genotyping revealed genotype in all cases. the month-dependent incidence ranges from : to : , blood donations with a peak in june and july. summary/conclusions: the high number of identified hev rna positive donors emphasizes the need for hev-nat screening to increase the safety of blood products. this study further confirmed that hev infection is common in german blood donors. background: zika virus (zikv) is a mosquito-borne virus that has caused outbreaks in central and south america in february , and has threatened the safety of blood transfusion globally. there is a high risk of zikv transmission by whole blood and blood components transfusion. it was reported that, zikv rna in infected patients plasma can only be detected within to weeks. however, in whole blood, zikv rna might present positive up to day after the symptoms appear in some patients, even if the clinical symptoms disappeared with zikv rna negative in plasma. this phenomenon suggested that the presence of zika is associated with red blood cells (rbcs). moreover, another report showed that viral load in whole blood of type a west nile virus (wnv) patients was higher than type o, implying that the binding of virus to rbcs may be related to blood group glycoprotein. both of zikv and wnv are member of the flavivirus genus. the study is intended to explore whether zikv have the same adherence mechanism to rbcs as wnv. aims: to investigate the distribution of zikv in blood components and adherence of zikv to different blood types of rbcs in whole blood. methods: five units for each blood type of a, b, o and ab whole blood were randomly selected. each unit of ml whole blood was divided into two half-unit. zikv was added to one half-unit in a certain proportion, and incubated at °c for days. each component of whole blood was collected for viral load detection. in the other half-unit,rbcs were suspended in the same type pools of plasma with equal volume after the plasma removed from the whole blood after centrifugation. zikv was added with the same certain proportion, and then incubated at °c for days. the whole blood samples and the upper plasma by centrifugation were collected detected for zikv rna. meanwhile, rbcs were washed and resuspended with normal saline followed by viral load detection. results: zika rna of these samples which extracted from whole blood, rbcs, and plasma were determined in a quantitative reverse transcription pcr, and viral rna of each component was all up to copies/ml. although, zikv rna loads did not show significant difference in distribution between rbcs and their corresponding plasma components, zikv rna quantification were significantly higher than those in plasma (p < . ) in type o rbcs and lower than those in plasma (p < . ) in type ab rbcs. summary/conclusions: in our study, we detected high viral rna loads in rbcs. it was demonstrated that zikv adheres to erythrocyte in whole blood, and the blood type may have influence on the adherence. background: hong kong is not endemic for dengue virus (denv) with most of the documented cases being imported. the presence of sufficient number of mosquito vectors, aedes albopictus, in the territory has led to two self-limiting indigenous outbreaks affecting residents from to . during august to september , another outbreak of confirmed cases of autochthonous dengue fever were reported to the department of health, linked to two epidemiological clusters, one in lion rock park near wong tai sin (wts) district ( cases) and the other in cheung chau, an outlying island ( cases). aims: we assessed the risk of dengue transmission from blood donors during the outbreak using a simplified version of the probabilistic model developed by biggerstaff and petersen (b-p) and the european up-front risk assessment tool (eufrat) model (oei, transfusion, ) . methods: patient demographic and general population data were obtained from the centre for health protection and the department of census and statistics of the hong kong government for the number of -to -year-old patients in the outbreak and residents of the same age range in hong kong and wts district as at mid- respectively ( - years old being the eligible age range for first time donation). to apply the b-p model, we estimated denv incidence among donors in hong kong territory and in wts with confirmed denv infection during august to september after correction for clinical:subclinical infections ratio, the mean length of asymptomatic viraemia and the probability of collecting blood from asymptomatic donors as described previously (seed, transfusion, ). to estimate the risk using eufrat model, outbreak and blood donation variables were entered into eufrat's web-based interface (https://eufrattool.ecdc.europa.eu/), which provided automatic calculation of risk-related output parameters. results: while using the b-p model, the estimated risk of collecting a denv viraemic donation was one in , ( , - , , ) territory-wide for the -day study period but increased to one in , ( , - , ) in wts. similarly while applying the eufrat model, the risk of encountering a viraemic donor was in , ( , - , ) territory-wide and in , ( , - , ) in wts during the same period. the eufrat also predicted a territory-wide issue of . unit of denv-contaminated labile blood component during the outbreak period. summary/conclusions: like many mosquito-borne infections such as denv, the risk is characteristically localised and varies geographically and seasonally during outbreaks. the average predicted risk of collecting a denv-viraemic donation territory-wide is low at in , during the outbreak based on the b-p model, which was generally considered as tolerable. however, the risk increased by folds when blood donations were collected from wts residents, who had higher chances of paying visits to lion rock park in close proximity. it was then justifiable to institute risk mitigation policies such as geographically-based deferral and/or fresh component restriction, enhanced post-donation reporting, etc. to protect against blood safety. background: hev is a developing threat to blood safety following the reporting of several cases of transfusion transmission hev (tt-hev). transfusion-related hev infection has been reported in several countries but its true frequency is probably underestimated because it is often asymptomatic and testing of blood donors is infrequent. pakistan is classified as a highly endemic region; with sporadic cases of hev occurring throughout the year, mainly affecting the adult population. to the best of our knowledge, no studies have been reported from pakistan on the epidemiology of hev in blood donors. aims: to assess the epidemiology of the hev specific antibodies and serum alt levels in blood donors of capital twin cities of pakistan. methods: this cross sectional study was conducted from july to december at three blood banks in the capital twin cities (rawalpindi and islamabad) of pakistan. the blood donors were equally distributed across the three blood banks. only donors who tested negative for hiv, hbv and hcv were included in the study. serum alt levels were analyzed by using automated clinical chemistry analyzer (selctra pro m) using merck kits. all samples were tested for hev-specific antibodies (igm and igg) by using enzyme linked immunosorbent assay (elisa) kits (adaltis, italy). statistical analyses were performed using spss software version . (ibm). results: in our study population there were ( . %) males and ( . %) females. the mean age of recruited blood donors was . (sd ae . ), with a range of - . younger donors were more common with a frequency of - year olds of ( . %). we found an overall hev igg prevalence of . % and an hev igm prevalence of . %. there were ( . %) blood donors who were positive for both igg and igm antibodies. our results revealed that the hev specific antibodies (igg, igm) prevalence increased with age. the mean value of serum alt was . (sd ae . ) with a range of - iu/l. the serum alt levels were elevated (> iu/l) in ( . %) blood donors. there was significant correlation (p=< . ) between serum alt level and hev specific antibodies for igg and igm. summary/conclusions: this study shows that a significant proportion of blood donors at our blood centers have been infected with hev and may be able to cause tt-hev. as we have not yet measured hev rna, we have used igm antibodies as a proxy for donors who have active infection. hev is generally asymptomatic, so it is debatable whether mandatory hev screening in blood donors should be required. results of this pilot study show that there is a need to conduct a larger study at national level with highly sensitive assays before making screening for hev mandatory in pakistan. background: hepatitis e virus (hev) is a zoonotic virus. who estimates that there are million hev infections, million acute hev cases and thousands hevrelated deaths worldwide each year. in recent years, the prevalence of hev in european and american countries has increased significantly. the survey results show that the positive rate of hev igg in blood donors is respectively . % in new zealand, . % in britain, . % in denmark, % in the united states and . % in the netherlands. hev has become a global public health concern. in addition to the food route of infection, several cases have been reported that hev can be transmitted via blood products. aims: to investigate the prevalence of hepatitis e virus (hev) infection among voluntary blood donors and potential impact on blood safety in guangzhou china. methods: blood samples from blood donors were collected from april to april at the guangzhou blood center and were tested for anti-hev igg antibody (hev igg), anti-hev igm antibody (hev igm) and hev antigen (hev ag)by enzyme linked immunosorbent assay (elisa). hev rna detection was performed on hev antigen positive samples by rt-pcr. the association of age, gender, ethnicity, occupation and alt with hev igg and igm were analyzed by chi-square test. multivariate logistic regression analysis was applied to identify the independent risk factors of hev infection. results: the positive rates of hev igg, igm and hev ag were . % ( / ), . % ( / ) and . % ( / ), respectively. no positive hev rna was detected. age and ethnicity were independent risk factors for hev igg and hev igm. the rate of hev antibody increased significantly with age (igg or = . , p < . ; igm or = . , p < . ). donors who were zhuang minority ( . %, . %) showed higher anti-hev than those who were han ethnicity ( . %, . %), and the difference was statistically significant (igg or = . , p = . ; igm or = . , p < . ). in addition, we found that occupation was an independent risk factor for hev infection, where students showed the lowest anti-hev rate. summary/conclusions: the results indicate that the positive rate of hev antibody among blood donors in guangzhou is high, and the infection status differs in different populations. our study provides basic data for the estimation of risk of transfusion-transmitted hev. background: human cytomegalovirus (hcmv) belongs to the viral family of herpesviridae. it is an enveloped double-stranded dna virus, widely distributed in the human population ( - % seropositive subjects worldwide) and cause of severe disease in immunocompromised patients and upon infection of the foetus. in normally healthy subjects, hcmv persists lifelong without clinical manifestation undergoing alternating phases of active viral replication and latency. since hcmv can be readily detected in blood, as free virus as well as associated to neutrophils and monocytes, hcmv transmission is a complication of blood transfusion. even though leukoreduction of blood products has been shown to significantly reduce the risk of hcmv transmission, higher inactivation standards may be required for high-risk, immunocompromised groups of patients. aims: in this study, murine macrophages infected with murine cytomegalovirus (mcmv) were used as a model to study the inactivation cell-associated cmv in human plasma using the theraflex mb-plasma system (macopharma). methods: mcmv expressing the green fluorescent protein was used to infect murine macrophages. infected macrophages were harvested h after infection, washed and used for spiking of plasma. plasma units (n = , ml) were spiked with infected cell suspension ( % v/v) and treated with the theraflex mb-plasma system according to the manufacturer's protocol using the macotronic-b illumination device (macopharma). samples were taken after spiking (load and hold sample), after illumination with different light doses ( after addition of mb, , , and [standard] j/cm ) and after blueflex filtration. mcmv titers were determined by endpoint titration and large volume plating on murine fibroblasts. infectious virus, which expressed gfp in infected cells, was detected using a fluorescence microscope. results: the results of infectivity assay showed that the treatment of human plasma by the theraflex mb-plasma system inactivated cell-associated mcmv in a dosedependent manner. after spiking with mcmv infected macrophages a mcmv titer of . (bag no. ) and . (bag no. ) log tcid /ml was achieved in the plasma units. in hold samples, a mcmv titer of . (bag no. and bag no. ) log tcid /ml was determined. the illumination step of the theraflex mb-plasma treatment procedure efficiently inactivated mcmv. already three-fourths of the standard light dose decreased infectivity of cell associated and remaining cell-free mcmv to infectivity levels below the limit of detection (≥ . log). further investigations would be needed to evaluate the log reduction capacity of the blueflex filtration step for cell-associated mcmv. summary/conclusions: the results with the murine model virus suggest that the theraflex mb-plasma system is an effective technology to inactivate cell-associated cmv in human plasma units. background: the use of pathogen inactivation (pi) technologies for platelet concentrates and plasma is slowly but steadily increasing. methods for treatment of red blood cells (rbcs), the most commonly used blood component, are still under development. aims: a novel approach for pi in rbc units employing uvc light was developed. methods: pi treatment was applied to full-scale rbc units after leukodepletion. the pi capacity of the uvc-based method was evaluated by bacteria and virus infectivity assays. a panel of in vitro assays to measure quality, metabolism, functional, morphologic, and blood group serology variables was applied to a pool-and-split approach in which pathogen-reduced rbcs were investigated in comparison to untreated rbcs. results: uvc treatment caused dose-dependent inactivation of bacteria and enveloped and non-enveloped viruses in rbc units. at a full dose, the mean log reduction factors ranged from . (bacillus cereus) to . (serratia liquefaciens) for the tested bacteria, and from . (emcv) to ≥ . (vsv) for the tested viruses. uvc treatment did not alter rbc blood group antigen expression. quality of uvc-treated rbcs was maintained during storage, e.g. hemolysis in uvc-treated and untreated rbcs were well below . % until day of storage. summary/conclusions: the data obtained until now show that uvc irradiation is a potential new method for pi in rbcs and justify further development of this process. background: histo-blood abh antigens are the mayor allogeneic antigens in human and they are widely distributed in almost all tissues. the expression of a- , -fucosyltransferase (fuct ), encoded by fut gene, determines the secretor status of an individual. about % of caucasian population have a functional copy of fut (secretor gene) expressing abh blood group soluble antigens in organic fluids such as saliva and seminal plasma. this individuals are known as "secretors". soluble abh blood group antigens have been associated with several metabolic and infectious diseases as well as reproductive failures. the incidence of infertility related of both male and female factors continues to rise despite many advances in reproductive technologies. it is well known that abo antigens are expressed on sperm membrane and in seminal fluid of secretors as well as abo antibodies are present in cervical mucus. in previous studies we observed significant loss in progressive motility of spermatozoa of non-secretors compared to secretor ones caused by specific cervical mucus antibodies in abo-incompatible couples. in addition, sperm cells are haploid cells, so that a heterozygous individual has two sperm subpopulations, each expressing the corresponding allele. the specific antibody of cervical mucus will attack only its complementary sperm. aims: to evaluate the prevalence of secretor character in men belonging to fertile and infertile couples in order to investigate a possible association with reproductive success. methods: samples of semen, from infertile men and from fertile controls were studied. comprehensive infertility evaluation was performed in all patients according to who criteria. secretor phenotype was evaluated in seminal plasma by inhibition of hemagglutination assay using saline erythrocyte suspensions, monoclonal antibodies anti-a, anti-b and lectin from ulex europaeus (anti-h). to distinguish between abo genes, genomic dna was extracted by an enzymatic digestion method. pcr was designed with two sets of oligonucleotides that allow to amplificate two different regions of the transferases without use of restriction enzymes. by comparison of bands of the pcr products, the individual genotype was determine. cervical mucus antibodies of their female partners were titrated with the corresponding red blood cells. results: results were analysed in both groups. in infertile couples with abo incompatibility, the frequency of non-secretor phenotype of male partners ( . %) were significantly higher than those from fertile couples ( . %) (p < . ) the results obtained by pcr in sperm cells correlated % with red cells phenotypes. summary/conclusions: incidence of infertility continues to increase. several factors have a negative impact on men's reproductive health. immunological implications are now being studied and considered as a cause of failure in sperm-egg interaction, even among normal gametes. secretor phenotype in male partners could help reproductive success by blocking cervical abo antibodies. furthermore, if the male is heterozygous, cervical mucus antibodies will only affect the corresponding sperm. we propose to evaluate abh antigen expression on sperm membrane and seminal plasma as well as abo antibodies in cervical mucus to contribute to the diagnosis and treatment of human infertility. background: the h blood group contains one antigen, the h antigen, which is present on virtually all red blood cells (rbc) and is the acceptor substrate of both a and b gene-specified glycosyltransferases. in blood group o the h antigen remains unmodified and therefore its rbcs show the highest and the rbcs of blood type ab the least amounts of h antigen. individuals with the so called bombay phenotype carry homozygous h null alleles (h | h) and do not produce any h antigen. the para-bombay phenotype retains some h antigen on rbcs either induced by a weakly active (h+ w | h+ w ) or completely silenced fut gene (h | h), mandatory linked with an active fut gene. aims: in this study, we aimed to develop an adapted flow cytometric method to quantify the relative amount of h substance present on rbcs in order to distinguish different abo phenotypes in routine diagnostics as well as to capture rare h-deficient phenotypes. methods: analyses were performed on a flow cytometer (facs canto ii, bd biosciences, ch) and measured with identical instrument settings. list mode data were evaluated and visualised using bd facsdiva software. rbcs were incubated with increasing concentrations of monoclonal anti-h antibodies (bric -pe and a : mixture of bric -pe/bric , ibgrl, uk). after rinsing the cells with pbs, micro-aggregates were mechanically dissolved. rbcs from blood donors with different abo phenotypes (o ( ), a ( ), a ( ), b ( ), a b ( ), a b ( )) and patients with genetically confirmed bombay and para-bombay phenotype were assessed. results: saturation of h antigen binding sites on type o rbcs was achieved only upon use of a : antibody mixture (bric -pe/bric ) covering approx. half of the h-binding sites by unconjugated bric . in contrast, non-o type rbcs reached saturation of h-binding sites using pure bric -pe. rbcs coated with bric -pe at saturation revealed a distinct pattern of mfi (mean fluorescence intensity) depending on the abo phenotype. in addition, mfis of rbcs upon staining with bric -pe did discriminate bombay-and para-bombay type rbcs, respectively. summary/conclusions: adapted flow cytometry is able to distinguish variant expressions of rbcs h antigen. thus, our flow cytometric method may complement traditional serological and genetic analyses in routine abo phenotype cases or, more intriguing, when the bombay or para-bombay phenotype is suspected. it will be of interest to further prove this method by investigating additional rare h-deficient phenotype cases. s chen , , x xu , , x hong , , k ma , , j he , , j chen , and f zhu , blood centre of zhejiang province zhejiang provincial key laboratory of blood safety research, hangzhou, china background: weakened a and b antigen expression results in abo typing discrepancies. h gene controls the development of h substance from which a and b antigens develop. depressed a and b antigen expression and strengthened h antigen expression are always simultaneously observed in abo subgroups. there are other possibilities for weak antigen expression of abo system such as leukemic change and pregnancy. it is undiscovered whether abnormal expressions of a, b and h antigen stand for abo subgroups in hemopathic patients. aims: the aim of this study is to explore the role of enhanced reactions with anti-h in direction to abo subgroups of hemopathic patients. methods: samples from blood donors and hemopathic patients with nonconcordant abo typing by serological tests were collected after consent information. the agglutination strength of these rbcs with anti-h reagent was recorded. enhanced reactions were determined by comparison with the results from normal abo groups. the genomic dnas of samples were extracted and genotyped for abo system. this work was sponsored by the medical science research foundation of zhejiang province ( rc ). results: samples in blood donors showed increased expression of h antigen, of which were identified as abo subgroups. there were enhanced reactions in hemopathic patients. however, were finally confirmed as normal abo genotypes. no statistical significance ( . % vs . %, p > . ) in the frequency of strengthened h antigen expressions was observed between donors and hemopathic patients. the total number of subgroups is and respectively in blood donors and hemopathic patients. extremely significant statistical differences ( . % vs . %, p < . ) existed in the frequency of subgroups with enhanced h antigen, which meant the possibility of subgroups in hemopathic patients samples was less. summary/conclusions: the expression of h antigen is comparably enhanced in subgroups and hemopathies. but most of hemopathic patients with strengthened h antigen expression present normal abo genotypes. as a result, the enhanced reaction with anti-h is necessary but not sufficient for serological identification of abo subgroups in hemopathic patients. background: although the use of automated blood bank analyzer with the advantages of speed and efficiency has recently increased, the abo discrepancies in automated blood bank analyzer have caused the reporting delays of the results and increase of the task. aims: we analyzed the causes of abo discrepancies in automated blood bank analyzer and suggested a solution strategy based on the causes. methods: from november to january , cases ( . %) of abo discrepancies among , abo blood type tests performed using the -min reaction mode of ih- in chonbuk national university hospital blood bank were identified. we compared the test results of -min mode with results of immediate mode using different red cell reagents, and analyzed the causes of discrepancies by performing additional tests such as microscopy, auto-control, antibody screening and identification, anti-a and abo genotyping. results: in the immediate reaction using different red cell reagents, cases ( . %) of discrepancies disappeared and cases ( . %) remained discrepancies. all abo discrepancies observed in the -min reaction were due to serum side causes, and one case ( . %) was due to both of serum and red cells side cause. nonspecific response ( cases, . %), cold antibody ( cases, . %), rouleaux formation ( cases, . %), cis-ab ( cases, . %), and abo subtype ( case, . %) were analyzed as causes of discrepancies. one discrepancy due to cis-ab was disappeared in the immediate reaction using different red cell reagents, abo subtype was changed to totally different blood group, a. on the other hand, in cases of the discrepancy corrected by the immediate reaction using different red cell reagents, the intensity of the positive results still observed in immediate reaction was not different from the -min reaction. summary/conclusions: ih- , an automated blood bank analyzer, was considered useful for automation of abo blood typing, and some observable abo discrepancies are expected to be mostly addressed by reexamining with immediate reaction mode using different red cell reagents. abstract withdrawn. background: abo blood group antigens mainly expressed on red blood cells, but along with that they also present on many organs and tissues like epithelia, platelets, vascular endothelia and neurons etc. the importance of abo antigens extends beyond transfusion medicine by association with various systemic diseases like cardiovascular diseases, gastric diseases, cancers, infectious diseases etc has been proven previously. previous researchers also tried to find out the involvement of abo antigens in neurological diseases like alzheimer's disease, parkinson diseases etc. but association with neurological tumours is less explored. aims: this study aimed to analyse the association of abo blood group antigens with neurological tumours. methods: a retrospective study in a tertiary care institute in india analysed the years data from jan to dec . the carcinoma patient's admitted in neurosurgical department during study period were included in our study. their diagnosis and abo blood groups were collected from hospital information system. data were analysed into microsoft excel and spss (version ). results: during study period a total of patients with neurological tumours were admitted in our hospital. the blood group frequency of these patients were . %, . %, . %, . % for a, b, o and ab respectively. the common neurological tumours found in our study were glioma ( . %) followed by pituitary adenoma ( . %), meningioma ( . %), schwannoma ( . %), cavernoma ( . %), neuroma ( . %) and space occupying lesions ( . %). the prevalence of abo antigens was almost similar in all neurological tumours except in neuroma. neuroma was found in . % o group patients as compared to other blood groups which was found statistically significant (p < . ). summary/conclusions: in this study we tried to analyse the association of neurological tumours with abo blood groups antigens. we found there is no association of neurological tumours with abo blood groups because the prevalence on abo group in general population is almost similar in patient with neurological tumours except neuroma. neuroma group of tumours like neurofibroma, neuroblastoma, nerve tumours etc. were more common in o group of patients while in our population frequency of b blood group antigen ( . %) is more common as compared to o blood group( . %). background: rhd and rhce represent homologous genes in head-to-head position on chromosome (chr , p . ). they encode for the proteins rhd resp. rhce which compose together with rhesus associated glycoprotein (rhag), band and ankyrin the ankyrin complex (ac) linking the red blood cell (rbc) membrane to aspectrin of rbc cytoskeleton (s.e. lux, blood, ). cooperatively, the proteins of ac are important for maturation and physiologic properties of rbcs. many proteins of the rbc membrane express blood group antigens on their extracellular surface and are therefore of concern in transfusion medicine. cepellini et al. described weakened hemagglutination reactions of rhd+ rbcs in the presence of an rhc+ antigen (cepellini et al, pnas, ) . we attempted to further elucidate the expression of rhd/rhag proteins in various rhce/rhce pheno-/genotypes using a sophisticated flow cytometry approach. aims: in this study, we investigated a flow cytometric method for measurement of the antigen-density of various rhce-phenotypes. methods: analysis was performed on a flow cytometer (facscanto ii, becton dickinson (bd)) using bd facsdiva software and identical instrument settings for all samples. optimized number of rbcs was incubated with saturating concentration of pe-conjugated anti-rhd antibodies brad- /brad- /fog- (ibgrl, bristol, uk). debris was excluded by rbc gating in fsc/ssc plot. quantibrite-pe beats (bd) were applied according to manufacturer's instruction to quantify the relative expression of rhd epitopes. in addition a representative number of samples from common phenotypes were assessed for expression of rhag using bric- pe (ibgrl). results: a total of samples from healthy blood donors with serologically defined rhcde phenotypes were included into this study (rr( ), r r( ), r r ( ), r r( ), r r( ), r r ( ), r r ( )). variant expression of rhd by different rhce phenotypes using brad- -pe was shown. rhd was weakly expressed in presence of rhc antigen (cepellini effect). effect of rhd gene dose on rhd protein expression is mitigated by rhc/c genotypes. when only samples with molecularly confirmed phenotypes were assessed, the rhdce genotype predicts consistently the strength of rhd protein expression. outlier samples ( ) were retrospectively genotyped and revealed rhdce genotypes as expected from the strength of rhd expression falsifying serological rhcde phenotypes. in contrast, rhe/e polymorphic site does not correlate with rhd expression. in addition, rhag protein is equally present across all rhcde phenotypes. similar results were obtained by using alternative anti-d antibodies such as brad- -pe and fog- -pe, although different antibody's avidity precludes quantitative comparison of antigen expression on rbcs. summary/conclusions: sophisticated facs methods reveal different expression of rhd on rbcs according to rhce/rhce phenotype/genotype. rhc/c polymorphic sites (c. g>c, c. a>g, c. a>g of exon , exon resp. and intron ) are in linkage with rhd expression, confirming the observation by cepellini et al. in contrast, rhe/e (c. c>g, exon ) is not in linkage with rhd expression. based on epigenomic signature it is conceivable that altered transcription factor binding sites (tbs) of rhd mirrored by homologous rhc/c may cause variant rhd expression. rhe/e snp mirroring the homologous sequence of rhd in exon is not recognised as tbs. in addition, although ac comprises all three rh proteins (rhd, rhce, rhag), their transcriptional regulations seem to be distinct. red cell reference laboratory, australian red cross blood service, perth, australia background: the rh antigen was first described when an antisera thought to contain a potent anti-c did not react with all c+ cells. these non-reacting c+ cells were classified as c+, rh:- , and the antibody specificity anti-rh . most polyclonal anti-c contain anti-c and anti-rh . previous studies have shown of monoclonal anti-c reagents are actually anti-rh . these reagents will not detect the c antigen where the red cells are rh:- . aims: the australian red cross blood service investigated a phenotype discrepancy in a blood donor. the donor's historic phenotype c+ (r r) was inconsistent with the current donation phenotype c-(r r ). we aimed to investigate the cause of the discrepancy so the donor could be assigned the correct phenotype, identify the root cause of the discrepancy and implement any corrective actions. methods: the donor's red cells were phenotyped with all available anti-c reagents as per the manufacturers product insert across both manual and automated testing platforms. following variable results and weaker reactions with some reagents, dna was extracted from the edta sample and was genotyped using immucor bioarray tm hea precise and rhce beadchip tm . targeted dna sequencing of rhd and rhce was also performed using the trusight tm one sequencing panel. a review of the historical phenotype results, including the testing platform and reagents used at the time was also performed. results: on the current sample the donor's red cells gave a + reaction by tube with bio-rad seraclone â ( ) [clone ms ] and immulab epiclone tm [clone anti-c reagents. the sample tested negative on the beckman coulter pk using beckman coulter anti-c [clone ] blood grouping reagent and tested positive ( ) reaction on the immucor neo using immuclone â ( ) anti-c [clone . immucor bioarray tm hea precise beadchip tm predicted a c+ phenotype and no variants were detected with the bioarray tm rhce beadchip tm . the trusight tm one sequencing panel genotyped the donor as rhd* /* n. and rhce* . /* with a predicted phenotype of c+, c+ w , d+, e-, e+, rh: (locr+), rh:- . a review of the donor's historical records indicated the donor tested as c+ on the pk , which at the time was being used with an in-house bromelain preparation (sigma-aldrich) and diagast olymp pheno anti-c reagent [clone ms ]. summary/conclusions: results indicated the phenotype discrepancy was caused by the c+ rh:- variant associated with the rhce* . allele. reagents containing clones ms- and ms correctly phenotyped the donor as c+, with the manual tube reagents showing a weaker reaction which may alert the operator to a possible variant which is important in the patient setting. the beckman coulter pk and associated anti-c [clone ] failed to detect the c antigen. this reagent appears not to detect the c antigen where it is associated with the rh:- phenotype, which is in contrast to the previous report by faas et al, transfusion, where it was demonstrated that clone reacted with c+ rh:- bromelain treated red cells. abstract withdrawn. background: although serological rhd typing has always been challenging due to variation of techniques and variable sensitivity of anti-d reagents, most individuals are unequivocally typed as either rhd positive or rhd negative. however, variants of d (weak d and partial d phenotypes) may present typing difficulties. individuals with partial d (missing epitopes of the d antigen) must be typed as rhd negative as blood receivers, but as rhd positive, as blood donors. aims: the aim of our study was to evaluate the algorithm used since at ahepa university blood center, to resolve rhd typing problems among first time donors. methods: since automatic analyzers may type variants of rhd as rhd+, our practice is to routinely perform two different typing methods in first time donors: an automated microplate method on the neo analyzer (immucor) and the slide test, using a potent reagent (anti-d blend-immunodiagnostika). in case of negative, weak, slow or mixed-field reaction, further testing with an automated microplate weak d method [immucor-modified indirect antiglobulin (anti-igg) test] follows. the next step of the protocol consists of testing with the commercial id-partial rhd typing kit (bio-rad) comprising a panel of monoclonal anti-d reagents, in an indirect coombs gel test assay. the patterns obtained with this kit can distinguish between d weak and partial d and can also differentiate between categories ii, iv, v, vi, vii dfr, dbt and dhar. the last step of our algorithm consists of molecular testing (immucor bioarray rhce and rhd beadchip assays) at the hellenic national blood transfusion center, in case of remaining uncertainty. results: we applied the above algorithm in samples: a) by using the partial d kit, samples were typed: four samples were characterized as "partial d" ( dfr, diii) and as "weak d". four of the weak d samples (all from women of reproductive age) were confirmed by molecular typing ("weak d type " three samples, "weak d type . or . " one sample). b) the nine ( ) remaining samples that showed atypical serological pattern, were sent for molecular testing, which characterized samples as "weak d type ", one sample as "weak d type " and another as "weak d type ". results are pending for samples. summary/conclusions: in our experience some partial rhds may be mistyped as rhd+ if the technologist does not inspect the pattern of the reactions and only takes into account the assignment by the automatic analyzer as d+ or d-. by use of our algorithm, serological characterization was sufficient to distinguish between weak d and partial d in , % of cases. molecular typing was necessary in the rest. the integration of molecular techniques improves the quality and accuracy of d typing of blood donors. if applied to patients, it also allows administration of d positive blood without compromising safety to those carrying prevalent weak d types that have not been reported to produce anti-d. furthermore, it permits withholding rhig in case of pregnant women carrying such weak d types. background: rhd antigen is one of the most clinically significant blood group antigens. except d positive and d negative phenotypes, there are over rhd variants, which represent as serologic weak d phenotypes (swd). patients with certain swd can make anti-d alloantibodies. by serology testing it is not possible to clearly distinguish among different swd. in croatian institute of transfusion medicine (citm) patients and pregnant females with swd are mostly reported as rhd negative and generally did not refer for confirmation, because molecular testing was not part of the algorithm. that remains the risk of shortages of rhd negative blood and overuse of anti-d immunoprophylaxis for pregnant females. according to uk guidelines patients with swd who are likely to require chronic transfusion support and females ≤ years are treated as d negative and refer for confirmation of d type. people who are rhd genotyped as weak d type , or are not susceptible for rhd alloimmunisation. one study showed that in croatian population the most frequent variants are weak d type , and . aims: the aim of this study is to estimate the prevalence of swd in patients and pregnant females and to find out serologic and molecular characteristics of swd referred for confirmation. methods: from / / to / / we analysed . samples of patients and pregnant females. rhd typing was performed by anti-d igm monoclonal reagents in direct agglutination micromethod on tango (bs , bs ) (biorad, dreieich, germany), swing maestro [lmh / (ldm ) + - and th- + rum- + ldm ] and ih- [lmh / (ldm ) + - ] (id-card, biorad, cressier, switzerland). cut-off value for tango was determined as ++ and for gel microtyping as +++. the samples with results below the cut-off were reported and treated as rhd negative, all except those which gave discrepant results at current testing or with historical data. these were sent to rhd genotyping for confirmation. dna extraction was done by qiaamp blood mini kit (qiagen, hilden, germany) and rhd genotyping by pcr-ssp kits ready geneweak d and ready genecde (inno-train, kronberg im taunus, germany). results: from . samples ( , %) were swd. / ( %) were referred to rhd genotyping. / ( %) samples were weak d type , or , while / ( %) were weak d type and partial d variants vii and va. serologic reactions with monoclonal igm anti-d reagents showed different pattern for weak d types , and . clearly negative serologic reactions were given in / samples with bs and bs , in / samples with lmh / (ldm ) + - and in / samples with th- + rum- + ldm . summary/conclusions: the prevalence of swd in this study is rather low ( , %). after rhd genotyping % of referred samples were finally reported as d positive. serologic determination of d variants is inconsistent and only rhd genotyping can resolve rhd status in swd. to define the permanent rhd status of swd female of childbearing potential and patients who are likely to be chronically transfused we will introduce rhd genotyping in the new algorithm. background: among all blood group systems, the antigens of the abo system are by far the most clinically significant. comes second in importance is the antigens of the rh system, which comprise d, c, e, c, and e antigens. another clinically relevant antigen is the k of the kell blood group system, which is known to be involved in both htr and hdfn. the distribution of the major blood group antigens, such as rh, and kell, is well-studied among populations of developing countries. in contrary, a relatively few studies have addressed their frequencies in saudi arabian population this is also the case in jazan province, where only two published studies have analysed the prevalence of abo and d antigens, while the frequency of other clinically important antigens, such as rh and kell antigens, is yet to be explored. aims: to determine the frequency of the following clinically relevant blood group antigens; rh(d, c, e, c, e) and k among saudi blood donors in king fahd central hospital in jazan province. methods: a retrospective, cross-sectional study was carried out in the blood bank of king fahd central hospital in jazan province. the red cell phenotyping records for blood donation of randomly selected saudi donors, who donated blood between january and june , were reviewed to identify the prevalence for the following antigens: d, c, e, c, e and k. the hospital blood bank routinely performs rh/k phenotyping for all blood donation using either bio-rad or ortho diagnostic column agglutination technology (cat) platforms. phenotype frequencies were expressed as percentages. results: this study included a total of saudi voluntary as well as family replacement blood donors. the d antigen was found to be positive in . %, while k antigen was positive in . %. among other studied rh antigens, e was the most common ( . %) followed by c ( . %), c ( . %) and e( . %). dce/dce ( . %) and dce/dce ( . %) were the most common phenotypes amongst d-positive and dnegative donors, respectively. surprisingly, dce/dce phenotype was significantly prevalent ( . %) with almost times higher frequency compared that reported in caucasians ( . %). the rare phenotype dce/dce was found in donors ( . %), while dce/dce and dce/dce phenotypes were found in only one donor each. summary/conclusions: this study is the first to determine the frequency of rh and k antigens in saudi blood donors in jazan province. determination of the frequency of these clinically significant antigens in our geographical area will facilitate the selection of antigen-matched red cell units for transfusion in recipients with multiple alloantibodies. it will also help in the management of blood donation processes and planning the estimated need of blood stock of different blood group phenotypes to meet the patient's needs. abstract withdrawn. background: the gerbich (ge) blood group system includes several high-frequency antigens located on glycophorin c and d. with only few reports published on the clinical significance of antibodies directed against these antigens, it is unclear whether blood transfusions have to be antigen negative in the presence of an anti-ge antibody. the monocyte monolayer assay (mma) is an in-vitro method used to estimate the clinical significance of alloantibodies. aims: to illustrate the role of the monocyte monolayer assay (mma) in the transfusion management of a patient with an anti-ge alloantibody. methods: the clinical and transfusion history was retrospectively retrieved from the patient's medical records. serological investigations were performed by indirect antihuman globulin test. papain and trypsin treated cells were also used. the clinical significance of the antibody was assessed by mma. genomic dna was isolated from whole blood and the samples were further characterized by pcr. results: a -year-old male patient with lung cancer without previous transfusions was admitted ( / ) for surgery. his hemoglobin was . g/l. an anti-ge antibody was detected and it was decided to transfuse ge-positive packed red blood cells (prbcs). however, no blood transfusion was needed. in july , the patient was admitted for colon cancer surgery with a hemoglobin of , g/dl. the anti-ge alloantibody was still detectable and a ssp-pcr revealed the genotype ge* .- . an mma performed on the pre-transfusion sample revealed a monocyte index (mi) of . % and the antibody was considered not to be clinically relevant. the mi was interpreted as following: - % not significant; - % inconclusive; > % clinical significant. however, due to the clinical background of the patient it was decided to transfuse ge-negative prbcs, which were obtained from etablissement francais du sang (efs), paris, france. two days after surgery, the patient received units of ge:- ,- prbcs without any transfusion reaction. one and a half year later ( / ), peritoneal carcinomatosis, as a complication of colon cancer, was diagnosed. the patient's hemoglobin was g/l and he had a passage disorder, symptoms of deterioration and an adynamia. based on the mma results from july indicating no clinical significance of the antibody, it was decided to transfuse ge-positive prbcs. in the following days the patient received a total of units of gepositive prbcs no immediate or delayed transfusion reaction were observed following these transfusions. two further mma's, performed on samples drawn on december th and th ( days after transfusion of a total of three and two days after two further prbcs respectively), showed a mi of . % und % respectively and the anti-ge antibody was considered still not to be clinically significant. summary/conclusions: we report the case of a patient with an anti-ge antibody transfused with ge-positive prbc. as ge-negative prbc are not available in switzerland and not easy to obtain internationally the mma can help in the decision on how to transfuse. in this case, the clinical course confirmed the mma-based prediction. transfusions of ge-positive prbcs were tolerated without signs or symptoms of immediate or delayed transfusion reactions. background: abo grouping discrepancies occur when the results of forward grouping are not corroborative to those of the reverse grouping. these may be due to weak subgroups of a and b, missing or weak abo antibodies or red cell alloantibodies. determination of correct abo blood group of a donor is essential for preventing abo incompatible transfusions and to avoid hemolytic transfusion reactions in the recipient. aims: to determine the frequency of abo discrepancies and their resolution to correctly identify the blood group of the donors. we also determined the frequency of 'weak d' positivity in rhd negative donors. methods: this was a retrospective study on donor samples collected from st april, to th september, (two and a half years). for discrepant samples, the abo and rhd grouping was repeated using tube technique using commercial antisera {anti-a, anti-b, anti-ab and anti-d (igm), anti-d blend (igm+igg), anti-h and anti-a lectins}. adsorption-elution testing was done for detecting weak subgroups of a and b. antibody screen ( -cell) and identification ( -cell) was done by gel technique (bio-rad, switzerland). 'weak d' testing in rhd negative donors was also performed by gel technique. antibody titration was done using tube technique. the donor details including name, age and the registration/unit number of the donation were also checked for all the discrepancies to avoid repetition while data analysis. results: we detected ( . %) abo discrepancies out of the total donor samples tested during the study period. out of these, ( . %) were rhd positive. the most common cause of abo discrepancies was weak anti-b antibody ( / ; . %), followed by weak anti-a antibody and weak subgroups of a ( / each; . % each) and weak subgroups of b ( / ; . %). the remaining . % ( / ) discrepancies were due to agglutination with o cells in reverse grouping. the overall frequency of weak subgroups of a and b collectively was . % ( background: detection of unexpected red blood cell (rbc) antibodies before transfusion is critical for prevention of hemolytic transfusion reaction. ideally, unexpected rbc antibody detection is carried out within days after receiving a patient's sample. however, in some cases, retests could be performed after more than days for evaluation of any transfusion reaction, quality control or research. therefore, it is necessary to determine the stability of antibodies after refrigeration or freezing for a certain period of time. aims: we carried out antibody identification test with fresh, refrigerated and frozen samples using automated analyzer ih- and manual tube methods to evaluate the stability of antibodies after storage and compare the results between the two methods methods: antibody identification tests were performed using ih- (bio-rad, cressier fr, switzerland) and manual tube methods. fifty samples showing positive results in antibody screening test by both methods were divided into three and tested immediately, week after storage at °c and month after storage at À °c. the specificities and reactivities of antibodies at each storage state were recorded and compared between the two methods. results: specificities of antibodies identified were concordant between ih- and manual tube methods irrespective of the storage state. the results were as follows: anti-e/e+c, ; anti-le a , ; anti-di a , ; anti-c+e, ; anti-m, ; anti-d, ; anti-c, ; anti-k, ; anti-jk a , : anti-xg a , ; unidentified antibody, ; autoantibody, cases. with regard to the changes in reactivity owing to storage, ( %) samples (anti-e+c, ; anti-m, ; anti-di a , ; anti-d, ; anti-c+e, ; anti-le a , ; anti-c, : autoantibody, ; unidentified antibody, ) showed identical reactivities after week and month storage by both ih- and tube methods. however, ( %) samples, comprising unidentified antibodies, anti-le a , anti-c+e, anti-e, anti-e+c, and autoantibody, showed decreased reactivities after storage in both methods. three samples, comprising anti-di a , anti-e+c and anti-k antibodies, showed increased reactivities after storage. one sample with anti-jk a showed increased reactivity only after month storage, while one sample with anti-xg a showed decreased reactivity only after month storage. higher reactivities were observed in all samples detected using the ih- analyzer than manual tube methods (p < . , wilcoxon rank sum test). summary/conclusions: the specificities of unexpected antibodies detected by ih- and tube methods were the same in all storage states; however, reactivities were higher in ih- than in the tube method. twenty-six ( %) of samples showed identical reactivities after week refrigeration and month freezing. nineteen ( %) samples showed decreased reactivities after storage; however, ( / , %) of them were nonspecific antibodies, unable to identify using commercial id panels. therefore, it is suggested that retests for evaluation of transfusion reaction, quality control or research could be reliably performed after more than days, if stored appropriately in refrigerated or frozen states. abstract withdrawn. t gleich-nagel , d huber-marcantonio , n rufer , g canellini and c niederhauser unit of transfusion medicine, interregional blood transfusion src, lausanne laboratory diagnostics, interregional blood transfusion src, bern, switzerland background: a positive direct antiglobulin test (dat) is mainly found in patients with warm/cold autoantibodies or alloantibodies directed against transfused erythrocytes. the identification of antibodies fixed on red cells is important for the clinician, allowing the further evaluation of a patient's clinical situation including their current medication. in immunohematology the elution of a positive dat remains a tedious and expensive procedure. the blood transfusion service src (bts src) has derived a flow chart that indicates in which situation an elution of dat positive samples should be performed. in order to follow the bts src guidelines, it is mandatory to obtain additional data related to the patient's condition, such as haemolytic parameters and recent transfusion history. currently, our laboratory is not always able to apply the recommended flowchart, since information is often unavailable. aims: here, we performed a comparative study between the algorithm provided by bts src and our in-house strategy, which is based on the qualitative changes of a positive dat, without the need for additional patient and biological information. methods: details of dat positivity and the patient's transfusion history was taken from the software eprogesa (mak-system) and analysed in excel. we analysed a total of ' dats and evaluated them for their positivity, whether an elution was performed or whether antibodies were detectable in the eluate. furthermore, we performed an additional analysis on those samples, that were derived from recently transfused patients (< days). results: a positive dat was found for igg and c d in out of ' ( . %) samples, a level similar to previous reports of positive dats for hospitalized patients. among these positive samples, ( %) were eluted because of a qualitative change in their positivity according to our in-house algorithm. identification of warm autoantibodies or alloantibodies occurred in only . % ( / ) of the cases. from the patients transfused within the last days and having a positive dat, ( %) were eluted according to our in-house algorithm. the same samples would have been analysed if the swiss transfusion guidelines had been applied. however, this comparative study reveals a significant discrepancy in regards to overall sample numbers that should have been eluted according to the two algorithms ( versus samples). this is mainly due to the fact that the swiss transfusion based algorithm does not recommend an elution of positive dats from patients who did not receive a transfusion within the last -days, except if there is a significant clinical suspicion (e.g. haemolysis). summary/conclusions: this comparative study indicates that our elution-based algorithm was performed on all clinically relevant samples as recommended by the bts src guidelines. qualitative changes in the dat positivity represent our main parameter for selecting those samples to eluate. besides ensuring that no clinically relevant samples were missed, this strategy also led to a large number of unnecessary elution analyses. in conclusion, a significant reduction in the laboratory workload and economical savings arises if the relevant clinical information and patients history is known prior to laboratory analysis. background: novel anti-cd monoclonal antibodies, such as daratumumab (dara) and isatuximab, used in treatment of multiple myeloma, interfere with routine blood bank serologic tests. as part of the strategies to manage these patients, it is recommended to perform extended phenotyping to provide matched units (aabb association bulletin # - ). many investigations have focused on the interference with iat for the screening and identification of underlying alloantibodies and how to overcome them, but less has been published on the potential interference with extended phenotyping techniques. aims: the purpose of this study is to compare different technologies to type the most important antigens in myeloma patients before and during the treatment with therapeutic anti-cd antibodies. vox sanguinis ( ) (suppl. ), - methods: edta-anticoagulated whole blood samples coming from patients in different stages of treatment with daratumumab and with isatuximab have been typed in parallel with dg gel microcolumn (grifols) and mdmulticard technology (grifols). the results are also compared with genotyping results obtained with id core xt (grifols). direct coombs, autocontrol and antibody screening has also been performed as complementary tests. results: the study provides that four patients had positive dat and/or ac before therapeutic cd antibodies treatment. in these cases, of negative antigens (fy / jk and/or s) turn to positive in gel technology but mdmulticard showed % agreement with genotype id core xt results. focusing in the data obtained during the treatment, negative antigens were type as positive in gel technology ( % of the tests). mdmulticard agreed with genotype in % of the analyzed antigens. as complementary data, of patient-treated samples had dat or ac positive and showed panagglutination. summary/conclusions: the results demonstrated that mdmulticard is an effective method to type cd -directed cytolytic antibodies treated samples in addition to dat and or autocontrol positive samples. background: antibody titration is a semi-quantitative method to estimate the strength and concentration of antibodies present in plasma or serum sample. titration methodology should be validated together with clinical data to evaluate the relevance of the titer value in each application. the titer of an antibody depends on different parameters: the antibody concentration in the sample, the density of the corresponding antigen expressed on the red blood cells used, the affinity constant of the antibody-antigen and other parameters regarding the technique used (e.g. gel cards or tube test). gel cards technology reduces the intra and inter-laboratory variation in titration studies comparing with the tube technique. aims: to evaluate the suitability of dg gel coombs, dg gel anti-igg and dg gel neutral (grifols) for titrations using two sample volumes ll and ll. methods: twenty frozen plasma samples containing unexpected antibodies from different specificities (anti-jk a , -fy a , -k, -d, -e and -c) were titrated in dg gel coombs and dg gel anti-igg cards and donor fresh plasmas with natural occurring antibodies (anti-a and -b) were titrated in dg gel coombs and dg gel neutral (saline technique). the titer of the antibodies was determined by testing two-fold dilutions of the plasma with selected red blood cells depending on the antibody tested. plasma samples were diluted in dg gel sol. selected red blood cells serascan diana, serigrup diana or donor blood were added into the card ( ll at . %). further, sample dilutions were dispensed into the card ( ll or ll). subsequently, cards were incubated min, °c (coombs technique) and min, - °c (saline technique), centrifuged in dg spin and the results read. agglutination intensity was graded visually according to the instructions for use of dg gel cards. the reciprocal of the highest plasma dilution that gives macroscopic agglutination was interpreted as the titer. results: titers obtained with dg gel coombs and anti-igg (n = titrations, titer ranged - ) were compared for each sample with unexpected antibodies. no differences were found between gel cards types (differences were ≤ . titer in the % of the cases). differences between dg gel coombs and neutral (saline technique) (n = titrations, titer ranged - ) were observed when anti-a and -b antibodies were titrated using the same sample. the titer was similar or higher in coombs in comparison to the saline technique. coombs titers may be a mix of igm antibodies reacting at °c and igg antibodies. differences were > titer in % of the comparisons and ≤ titer in the rest of the cases ( %). comparing sample volumes of ll and ll in all cards (n = titrations), higher titers were observed using ll, as expected. differences were titer in the % of the comparisons, < titer in % and > titer in the % of the cases. background: autoimmune haemolytic anemias (aiha) are characterized by production of antibodies directed against red blood cells and destruction by the mononuclear phagocytic system or complement system. aiha observed in paediatrics is usually self-limiting and often precipitated by viral infections. in some, the condition is secondary to autoimmune diseases, drugs, infections or underlying primary immune deficiencies. appropriate immuno hematological evaluation to characterise the underlying autoantibody can help identify the type of aiha to aid in diagnosis & treatment of these cases. aims: retrospective analysis of immune-hematological evaluation, treatment and outcome of aiha in paediatrics. methods: patients aged - years, diagnosed with aiha, between april -december ( months) were included in this analysis. aiha was defined as positive direct coombs' test (dct) with anemia associated with corroborative evidence of haemolysis in the form of raised indirect hyperbilirubinemia, raised ldh, raised reticulocyte counts or red cell agglutination on peripheral smear. further monospecific dct and evaluation for the specificity of autoantibody was done for all patients using biorad gel cards and panel cells. steroids were given as first line in all; second line agents included cyclosporine and rituximab. red cell transfusion was given in those with severe anemia with cardiac decompensation. results: patients were diagnosed during the study period with autoimmune haemolytic anemia. haemoglobin at presentation ranged from . to grams/dl. the initial presentation was severe anemia in children and mild-moderate anemia with thrombocytopenia (evan's syndrome) in . the trigger for haemolysis was infection in children. rheumatological evaluation was performed for children out of whom were diagnosed as evolving lupus. primary immune deficiency evaluation was advised for and one child was diagnosed as suffering from combined immunodeficiency. dat was positive in out of aiha patients as one of the infant had dat negative iga mediated aiha secondary to viral infection. two out of dat positive cases had igg & c d positivity on monoclonal dat testing whereas rest had only igg coating the red cells. dat titration was more than : in patients; where only of these patients had both igg and igg coating and rest had only igg . alloantibody screen was negative in all. specificity of autoantibody was found only in one case, which was against rh blood group antigen (anti e). all patients received prednisolone as the primary treatment. three children attained remission following a - weeks of steroids. in those who were steroid dependent, cyclosporine was used as the second line agent in and rituximab was used in . out of these children children are in sustained remission and off any medication, whereas the rest are on low dose steroids with cyclosporine. summary/conclusions: aiha is not an uncommon problem in children and can vary in its clinical severity. the proper diagnosis and management involves efficient immuno-hematological evaluation, as detailed characterization of the autoantibody coating the red cell is very important in guiding the clinician for management and prognosis. abstract withdrawn. background: drug-induced immune hemolytic anemia (diiha) is rare and has only been described once with dexchlorpheniramine (polaramine tm), an antihistaminic agent widely used in the treatment of a variety of allergic reactions. we report a case of diiha complicated with acute renal failure associated with antibodies to dexchlorpheniramine. a -year-old woman with no history of transfusion, was treated semimonthly with a combination of chemotherapy and targeted therapy for metastatic colorectal adenocarcinoma. her chemotherapy regimen consisted of oxaliplatin and -fu with leucovorin rescue (folfox). panitumumab (monoclonal antibody anti-egfr) was used as targeted therapy. premedication with dexchlorpheniramine iv was systematically given at the beginning of each cycle of treatment to reduce the risk of perfusion reactions mainly associated with panitumumab. the patient developed chills and febrile agranulocytosis during the first and second infusion respectively. the third infusion was not performed due to pyrexia, chills, general discomfort experienced by the patient at the beginning of chemotherapy. probabilistic antibiotherapy was administered and the patient recovered rapidly. during the next infusion (day ), following premedication with dexchlorpheniramine, a more "impressive" reaction including all the above mentioned symptoms occured along with back pain and dark colored urine. the infusion was halted and no chemotherapy was delivered. bacterial infection at the implantable port was first thought to be the cause of this adverse event but was not confirmed. additional laboratory findings revealed biological signs of inflammation associated with iha and acute renal failure. the patient was treated with hemodialysis (day ), two units of rbcs (day ) and was discharged one week later in stable condition. dexchlorpheniramine was then suspected and samples collected on day were sent for a diiha laboratory workup. aims: the aim of this study was to support a clinical diagnosis of diiha. methods: laboratory workup included direct and indirect antiglobulin tests (dat and iat). drug antibodies investigation was performed by incubating patient's serum and eluate from patient's rbcs in the presence of drug against normal donor rbcs that had not been previously treated with the drug (i.e., by the so-called "immune complex" method). control tests were performed in parallel. drug was diluted in pbs and tested at and mg/ml. results: dat was positive (anti-igg + , anti-c d + ) and no unexpected rbcs antibodies were detected by iat in patient's serum and eluate without the in vitro addition of the drug. an antibody directed against untreated (titer ) and enzymetreated (titer ) normal donor rbcs was demonstrated only in patient's serum in the presence of the drug tested at mg/ml by the gel method. the pool of normal sera did not react in the presence of the drug. summary/conclusions: the multi-drug treated patient described in this study was demonstrated to have dexchlorpheniramine dependent antibody detected by the "immune complex" method. the key to the diagnosis was the observation of positive dat with negative eluate tests which prompted a reexamination of the medications administered in temporal relationship with the hemolytic event. although rare, this case report should alert physicians to the need to investigate the possibility of dexchlorpheniramine induced hemolytic anemia in any patient who develop unexpected anemia after hematologic or oncologic procedures p- singapore, singapore, singapore background: daratumumab is a monoclonal antibody against cd used in the treatment of multiple myeloma and has been known to bind to cd on rbc's and interfere with indirect antiglobulin based serologic tests such as red cell antibody screens and crossmatch compatibility testing. in order to negate the interference of daratumumab, our reference laboratory follows the daratumumab protocol recommended by the aabb which uses dithiothreitol (dtt) treated reagent red cells in red cell antibody screening and identification test in patients known to have received daratumumab. aims: the objective of this study is to determine the impact of daratumumab in the turnaround time (tat) for red cell antibody screening and identification. methods: a retrospective review of the tat for red cell antibody screening and identification samples of patients known to be treated with daratumumab from october to december was performed. turnaround time is defined as the time the sample is received up the time the results were reported. the tat for routine red cell antibody screen and identifications were also reviewed during the same period and was compared with the tat of samples from patients treated with daratumumab. results: a total of patients on daratumumab had samples sent to our reference laboratory for red cell antibody screen and identification during the study period. information on daratumumab treatment was not provided to the reference lab prior to the start of testing in of the patients while the use daratumumab was mentioned in the serology request form of the other patients. the median tat for red cell antibody screen and identification is min (range: - ) if information on daratumumab was provided prior to start of testing and min (range: - ) if information was not provided prior to testing. the median tat for routine testing is min (range: - ). using wilcoxon rank-sum test, turn-around time for antibody screening and identification for daratumumab treated patients was observed as statistically not significant when compared to routine samples (p value . ). however, tat for serologic tests requests with appropriate medical history compared to the testing requests without relevant information was also observed to be significantly difference (p value . ). summary/conclusions: there is no significant impact in the tat of red cell antibody screen and identification in patients known to receive daratumumab as compared to routine testing. however, there is a significant difference in the tat if information on daratumumab treatment is not provided prior to testing. this highlights the importance of providing the relevant medication information in the request form in order to prevent delays in testing and provision of blood to patients on daratumumab, which can result in improved organizational efficiency and have positive impact on cost and resource savings. background: daratumumab, an anti-cd monoclonal antibody, has been shown to be highly efficacious in the treatment of multiple myeloma (mm). cd is a glycoprotein highly expressed on plasma cells and, to a less extend, on the surface of red blood cells (rbc). when bound to cd on rbc, daratumumab interferes with the pretransfusion tests, with positive antibody screening and crossmatch. anti-cd interference is an important challenge as many mm patients will require blood transfusions during their treatment. dithiothreitol is a reducing reagent with multiple applications in blood bank testing. treatment of rbc with dithiothreitol irreversibly removes cell surface cd tertiary structure, avoiding the binding and testing interference by the anti-cd daratumumab. aims: to demonstrate the efficacy, safety and celerity of the protocol between the blood bank (bb) and haemato-oncology of our institutions, using just the crossmatch. methods: a retrospective research was used for the evaluation of the results obtained from the implemented protocol. this comprehends a previous contact by haemato-oncology that leads to a study of the patient before the beginning of daratumumab treatment, and consists in: abo/rhd grouping; rh and kell phenotyping, and other clinically significant antigens; antibody screening; and direct antiglobulin test. genotyping may be required for some patients who received previous blood transfusions. before the beginning of the therapy, a blood sample of the patient is sent to the bb to perform laboratory tests and frozen after. this frozen sample is used for crossmatching in patients that already started therapy, did not have a blood transfusion in between, and have a positive antibody screening and/or crossmatch. in further transfusions, in case of positive tests, the dithiothreitol-treated donor rbc is applied. the donor rbc antigens are always selected accordingly to patients negative clinically significant antigens, when transfusional support is needed. the laboratory tests are executed in gel column agglutination technique. results: since , patients were studied, from which were transfused with blood units, according to the protocol. there were no immunizations or adverse reactions to transfusion registered within the transfused patients, neither delay on the availability of blood units. patient blood sample collected and frozen prior to the beginning of the treatment, has shown to be a good strategy by reducing significantly the waiting time for the blood unit in the first transfusion. summary/conclusions: this protocol, which defines the communication among the involved professionals, has shown to be a secure and effective way of reducing interferences caused by daratumumab. it ensures the previous study of the patients and their transfusion with rbc respecting the patients negative clinically significant antigens. if not adopted, the mitigation measures described in this protocol, delays in the availability of the rbc requested and alloimmunizations, may and will possibly occur. a good communication between the bb and the haemato-oncology is crucial for a good time management when a transfusion is requested for these patients. three methods were used to resolve this dara interference. reagent rbc's were treated with dtt, which know to denature cd and then tested with patient plasma. allo-adsorption study was performed using a certain ratio of red cells to plasma. in addition, a selection of phenotyped cord cells were used as an antibody screening panel. results: dtt treatment of reagent red cells was successful at eliminating dara interference and allowing for the presence of underlying antibodies to be identified. in this case, underlying antibodies were not detected by using reagent dtt treated red cells or phenotyped cord cells. adsorption technique was ineffective at elimination the reactivity. summary/conclusions: dara is the first commercial fda-approved therapeutic monoclonal antibody used in treating multiple myeloma patients. • since cd is weakly expressed on normal red blood cells, dara attachment to red blood cells can interfere with pre-transfusion iat testing. • dtt treatment of reagent red blood cells and cord cells can abolish the interference of dara to test for the presence of underlying alloantibodies. • to prevent delays in issuing red blood cell units to patients, hospitals should send patient samples to be tested before receiving dara treatment to ensure that clinically significant alloantibodies are not being masked. background: antibody screening (as)is considered superior to antihuman globulin (ahg) cross match during pretransfusion compatibility testing. in spite of knowing the utility and superiority of as, it has not been adopted uniformly in india. therefore, scarce data is available from this subcontinent in terms of optimisation of red cell antibody detection during pretransfusion testing in form of "type and screen" aims: the main objective was to study the benefits of performing simultaneous antibody screening along with the blood grouping during the first hospital visit to the hospital. other objectives were to study the prevalence of clinically significant antibody among the indian population and to follow up the patients who were transfused antibody screen negative but cross match incompatible blood. we also studied some other relevant quality indicators related to efficiency of blood transfusion services methods: this prospective study was carried out at a tertiary healthcare centre in india between july and dec ( months). the study protocol was submitted to institutional review board and permission was granted. blood grouping and as were done during patients' first hospital visit, which we called "type and screen". when the patient got admitted to the hospital and required blood transfusion, a blood request form was generated by the user and sent to blood bank. depending upon the results of antibody detection, further course of action was chosen. if patient was found to have no antibody, immediate spin test (ist) cross match compatible blood was issued and transfused. in such cases the procedure of ahg crossmatch testing was continued even after issue of blood. cases where ahg cross match test was found negative no further follow-up of the patient was done whereas when ahg cross match was found positive, patients were followed after the transfusion results: a total of patients were "type and screened". majority were from hemato-oncology, bmt, liver transplant, paediatric cardiac surgery, and medical icu units. clinically significant allo-antibody was detected in patients and autoantibody was detected in patients. alloantibody was detected mainly against rh and kell blood group systems. in diagnosed aiha cases, majority were in the form of warm aiha ( %) and % of aiha cases were having hidden single or multiple alloantibody. significantly higher proportion of patients in as positive group required blood transfusion than as negative group ( % vs %, p < . ). in both the groups, in planned cases, most of the time blood was issued immediately within the defined turnaround time except in where either transfusion was delayed or surgery was postponed. it happened only in trauma or surgical bleed cases. expiry of blood was decreased significantly due to no usage of blood ( . % vs. %, p < . ). during the period of study we obtained cases where the ist cross match was compatible but the ahg cross match was incompatible. during follow up none of the cases demonstrated any sign of hemolysis summary/conclusions: in developing countries like us, optimization of as during pretransfusion testing increases operational efficiency and significantly decreases the expiry of blood. results: during the period when absc was performed on pk , , donation samples were tested and , ( . %) were found absc positive. antibodies to red cells were identified in donations out of , ( . %) absc positive samples and in the rest, no irregular antibodies were detected. the prevalence rate for atypical antibody was . %. the top most frequent antibody specificities were: nonspecific cold antibodies ( . %), anti-e ( . %), anti-mi a ( . %), anti-m ( . %) and anti-le a ( . %). a total of , donations were screened for atypical antibodies by ih- and , ( . %) were screened positive. among these, anti-red cell antibodies were identified in , samples ( . %), which was significantly higher than those identified in pk screened positive samples (p < . ). the prevalence rate for atypical antibody as screened positive by ih- and with confirmed red cell specificities was . %, which was also significantly higher (p < . ). the top most frequent antibody specificities were: anti-mi a ( . %), anti-m ( . %), anti-le a ( . %), anti-e ( . %) and non-specific cold antibodies ( . %). anti-fy b was detected in cases, which would be missed detection by enzyme treated reagent cells on pk system. summary/conclusions: the performance of the ih- system using a -cell screening panel including one cell with mi(a+) expression and column agglutination technology with iat phase was superior in comparison with that of pk in the context of higher sensitivity in detecting more true positive results and higher specificity in detecting more true negative and less false positive results. this has translated into the advantages of reduction in workload of reference laboratory in performing less antibody identifications in those false positive samples as well as enhanced transfusion safety by removing more irregular red cell antibody positive plasma-containing components from the issuable inventory, which may potentially lead to haemolytic transfusion reactions. the prevalence of irregular red cell antibodies of . % in healthy blood donors in hong kong reflects more the true statistical figure. background: chronic red blood cell (rbc) transfusion is the upfront therapy for thalassaemia patients, however this therapy is featured by several adverse events including rbc alloimmunization. phenotype matched products transfusion policy can prevent alloantibody formation, but it makes routine transfusion more difficult for both the donor center and the transfusion service. a recent systematic review (franchini et al, blood transfus ) reported a rbcalloimmunization prevalence of . %, with a higher incidence against rh and kell systems in thalassemia intermedia patients. aims: the aim of our retrospective study is to evaluate the rbc alloimmunization prevalence in thalassemia patients transfused in a single center over a years period with limited phenotype matched rbc (rh and kell system antigens) units. methods: from to thalassaemia patients, with a minimum follow up of year and transfused with more than > rbc units, were included in our study. patients were studied for: blood group and rh / k phenotype determination, direct antiglobulin test (dat), irregular antibodies research (abirr). cross-match and detection of alloantibodies were performed using the indirect antiglobulin test by the column agglutination method. six-monthly dat and antibody screening were performed using the indirect antiglobulin test and enzymatic papain-treated rbc test. results: overall patients ( females, males) were included in our retrospective analysis: patients were affected by thalassaemia major and by thalassaemia intermedia. rbc alloimmunization prevalence was . % ( patients): patients were found to be positive for rbc alloantibodies, four with alloantibodies and autoantibodies. eleven alloantibodies were detected ( anti-h, anti-cw, anti-e, kpa, anti-jka, anti-jkb, anti-m and anti-lua). in out of alloimmunized patients we found an anti-e antibody reactive in enzymatic papain-treated rbc test only, in the third alloimmunized patient anti-kpa and anti-lua antibodies were detected, while in the remaining patients, in which auto and alloantibodies were detected, a severe autoimmune hemolytic anaemia (aea) requiring therapy was diagnosed. in these cases the appearance of alloantibodies is concomitant with the presence of autoantibodies. among the patients positive for alloantibodies, were affected by major thalassemia and one by intermedia thalassaemia summary/conclusions: in our experience a limited phenotype matched rbc transfusion policy showed a rbc alloimmunization prevalence similar to literature data: . % vs . %; we didn't find higher alloimmunization prevalence in thalassemia intermedia patients may be due to the low patients number. we believe that introduction, in our department, of an extended-phenotype matched transfusion, including antigens of the main group systems (fy, jk, mns) and the main rare antigens (cw, kp, lu), could reduce the risk of red blood cell alloimmunization in thalassemia patients. abstract withdrawn. background: undoubtedly, preventing alloimmunization has an advantage over overcoming its consequences. however, the high cost of technical and organizational aspects of preventive measures requires their scientific substantiation confirmed by clinical and laboratory data. selection of donors of the rhesus (d, c) and kell (k) antigens for the red blood cell transfusions to hematological patients has been regulated in the russian federation since . recipients with the phenotype c+c-transfuse red blood cell only with the same antigenic combination. for transfusions red blood cell obtained from k-negative donors are used. the compatibility of the donor and recipient with the antigens c, e, e, c w (rhesus system) and k (kell system) is additionally taken into account from april . that is, transfuse red blood cell that do not contain antigens in the phenotype that are not in the recipient's phenotype. aims: to evaluate the efficiency of red blood cell donor selection using antigens of rhesus (c, c, e, e, c w ) and kell (k, k) systems for the prevention of the recipient alloimmunization. methods: immunohaematological studies using equipment and reagents of biorad (usa) were performed in patients of the hematology clinic. non-hodgkin lymphoma was diagnosed in patients, acute leukemia in , multiple myeloma in , chronic lymphatic leukemia in , chronic myeloid leukemia in , aplastic anemia in , hemophilia in , myelodysplastic syndrome in , and other hematological diseases in . the frequency of detection of antibodies to antigen c ( . % vs . %) and to antigen e ( . % vs . %) decreased four times. the frequency of detection of antibodies to the c w antigen has not changed significantly ( . % vs . %, respectively). selection of antigens c (rhesus) and k (kell) has been carried out in the clinic since , therefore the immunization index for these antigens remained unchanged and amounted to . % vs . % for anti-c antibodies; . % vs . %for anti-k antibodies. alloantibodies to the antigens e (rhesus) and k (kell) were not detected for the entire observation period. summary/conclusions: research verified the effectiveness of alloimmunization prevention of recipients by selecting red blood cell for antigens c, c, e of the rhesus system and k (kell). the study concluded that selection of red blood cells for the antigens c w , e (rhesus) and k (kell) does not affect the level of alloimmunization of patients and is not clinically justified. background: in the russian federation, there is an order according to which patients requiring multiple transfusions, who are at high risk of immunological complications are to typed for red blood cell antigens: abo, d, c, c, e, e, cw, k, k. selection of erythrocyte-containing blood components is carried out taking into account the donorrecipient compatibility according to all the listed antigens. aims: analysis of results of immunological evaluation of patients of hematological clinic. methods: the study included first time patients of hematology clinic in - . typing of antigens of abo, rhesus, kell systems, screening and identification of antibodies were carried out using equipment and reagents from bio rad (usa). results: interpretation of results of immunohematological screening was complicated in ( . %) patients. the total number of complex cases was . the double population of red blood cell was most often determined in antigens of the rhesus system ( . % of the total number of patients) as a result of previous transfusion therapy. of those, chimera for the antigen e was detected in cases ( . % of patients with the chimera for rhesus and kell antigens), cin ( . %), sin ( . %), e - ( . %), cw - ( . %), k - ( . %). in such cases, donor red blood cells were chosen not carrying chimeric antigen for transfusions, in the presence of chimeras in both paired antigensred blood cell transfusion with the cc phenotype and / ee. chimera for abo antigens was detected in . % of the examined individuals. the discrepancy between the direct and reverse blood grouping of the abo system in patients ( . %) was due to a decrease in the production of antibodies - cases and the appearance of extra agglutinins - case. autoantibodies were detected in . % of all patients, including . % of patients, when they caused panagglutination phenomenon. upon detection of autoantibodies that complicate the individual selection of donors, transfused red blood cells that are compatible with antigens of abo, rhesus, kell, duffy, kidd, mns systems. alloantibodies were detected in . % of patients, including specific anti-din ( . %), anti-dcin ( . %), anti-kin ( . %); antibodies of unidentified specificityin ( . %), polyspecificin ( . %). summary/conclusions: the complexity of interpreting immuno-hematological tests in hematological patients is due to intensive transfusion therapy, changes in red blood cell antigens and appearance of nonspecific antibodies due to underlying disease. red blood cell for transfusion in these patients should be selected taking into account the expanded red blood cell antigen profile. abstract withdrawn. background: blood transfusion is an essential part of therapy for many patients. although life-saving for many patients, blood transfusion is not without risk. the main goal of blood transfusion services is that transfused blood should be compatible with the patient. the clinical and serologic evaluation, which allows for the transfusion of the most compatible (or "least incompatible") blood, requires a joint effort between the clinician and the transfusion medicine physician. aims: root cause analysis of incompatible cross matches in patients. methods: in this prospective study, total of , , crossmatches were performed over period of last four & half years, out of which units were found incompatible by column agglutination method-cat in polyspecific (anti-igg+ c d) gel media. a root cause analysis protocol was formulated to resolve incompatibility to ensure safe transfusion. results: on the evaluation of , , crossmatches, only units were found to be incompatible ( . %). the major cause for incompatibility found in patients was aiha-( . %). other causes of incompatibility were infections ( . %), multiple transfusions ( . %), trauma ( . %), evan's syndrome ( . %), rh negative mother ( . %), sca ( . %) & incompatibility due to dat positive packed red cells ( . %).the most common antibody found were anti-'c', anti-'s' & anti-'m'. summary/conclusions: the rca protocol involves a thorough evaluation of the patient's clinical condition and underlying pathology to identify the cause. a logical stepwise approach will enable provision of safe transfusion to the patient. background: antibodies to high-frequency antigens (hfas) are a transfusion hazard, as compatible blood is often very difficult to obtain. other clinically significant alloantibodies represent an additional transfusion risk. in patients treated with allogeneic bone marrow transplantation (bmt) recipient red cell alloantibodies may cause acute or delayed haemolysis of donor red blood cells (rbc) and contribute to morbidity and mortality. aims: the aim is to present the case of a patient with myelodysplastic syndrome (mds), multiple "common" alloantibodies and an additional alloantibody to a highfrequency antigen, treated with allogeneic bmt. methods: a forty-one-year-old caucasian patient with mds (raeb- ) was admitted to our hospital in january for unrelated allogeneic bmt. she previously received myeloablative conditioning therapy according to the flu / bu / atg protocol ( days of mg iv. fludarabine, days of busulfan mg iv, days of mg iv. antithymocyte globulin). the indirect antiglobulin test (iat), done in august and december of , was negative. according to anamnestic data, the patient had two pregnancies. she received red cell transfusions during childbirth and platelets in december . results: the patient's blood group was o rhd positive, iat positive. the donor blood group was a rhd positive, iat negative. phenotype of the recipient's rbcs, as well as the donor rbcs, was also determined. anti-e and -c w were found in the patient's plasma, but an additional alloantibody was suspected. the autocontrol was negative. column agglutination technology (cat) and tube technology were used to identify rbc antibodies. plasma was tested with pheno-matched rbcs, papain-and . m dithiothreitol-treated rbcs, as well as cord and autologous rbcs. adsorption and elution tests were done, excluding other "usual" clinically significant alloantibodies, and the patient received three incompatible (xm in iat, cat) yt(a+), e-, c w -, k-red cell units. the sample was urgently sent for an antibody investigation at the international blood group reference laboratory (bristol, uk). in the reference laboratory, anti-e, -c w and an alloantibody to a high-frequency antigen were confirmed, whose specificity was determined to be anti-yt a . anti-jk b was also suspected and later confirmed. before the patient was discharged from the hospital, she received eight more red cell units (yt(a+), e-, c w -, jk(b-)), during which she was serologically closely monitored. summary/conclusions: the results of the antibody investigation in this case study indicate the presence of multiple alloantibodies in a patient who has previously received immunosuppressive myeloablative conditioning therapy. in addition to the "common" alloantibodies (anti-e, -c w , -jk b ), an alloantibody to a high-frequency antigen (anti-yt a ) was detected in the patient. this patient was transfused with incompatible red cell units (yt(a+)) in an emergency, with no ill effects. although anti-yt a is rarely a clinically significant antibody, according to literature, it can cause immediate haemolytic transfusion reaction. additional risk were "common" clinically significant alloantibodies, especially anti-jk b , which was in this case extremely difficult to detect and had further complicated the selection of blood. background: the identification of an antibody against a high-incidence antigen always introduces a challenge due to the difficulty in finding compatible units of red blood cells (rbcs). in patients needing surgery it is important to minimize their transfusional needs by implementing patient blood management programs (pbm). tests that predict the clinical significance of antibodies, such as monocyte monolayer assay (mma) are also useful in guiding clinical decisions. kell blood group system contains highly immunogenic antigens. antibodies against these antigens are immunoglobulin g, and can cause severe hemolytic transfusion reactions and fetal anemia. results: case report we report the case of a -year-old female, with non-hodgkin lymphoma, chronic anemia and scoliosis with severe neurological compromise, proposed for lumbar spinal stabilization surgery. she had a total hip replacement surgery in , with unknown transfusion history. her obstetric history was g p a . the patient had no history of thromboembolic or hemorrhagic events. during pre-transfusional tests, she was typed as a rr and had a positive antibody screening test. the identification studies were suggestive of an antibody against a highincidence antigen, so the surgery was delayed until clarification of these results. she was also referred to a pbm appointment where her hemoglobin was improved from . g/dl to . g/dl by administration of ferric carboxymaltose iv and darbepoetin sc. the patient was phenotyped as kp(a+b-) with anti-kpb, an antibody against a highincidence antigen (> % prevalence worldwide). it is a rare antibody with variable reactivity, causing from none to moderate/delayed transfusion reactions. to access the clinical significance of this antibody, a mma was performed, resulting in a reactivity of . %, suggesting no clinical relevance, however it could be altered after transfusion of kpb+ blood. in order to find compatible rbc's, several family members were phenotyped, however they were all positive to the kpb antigen. in portugal there were no rr kp(b-) blood donors, as it is extremely rare, so we searched in the international rare donor panel (irdp) and two donors were found in spain. two units of compatible rbc's were requested prior to the surgery, which was performed successfully four months later without transfusional support. summary/conclusions: anti-kpb is a rare antibody that in some cases can cause hemolysis of the transfused kp(b+) red blood cells. the combination of kp(b-) and o rr, an extremely rare phenotype, presented a challenge in finding compatible rbcs. this case illustrates not only the complex transfusional and logistic problems that an antibody against a high-incidence antigen can pose, but also the importance of an efficient pbm programme to mitigate the transfusional needs in these patients. background: blood transfusion is an integral part of the supportive care for patients with sickle cell disease (scd). allo-immunization is a recognized complication to red blood cells transfusion (rbc) in those patients. this may result in difficulties in providing compatible blood, and may be associated with the risk of acute of delayed hemolytic transfusion reactions. aims: to describe transfusion management in a patient with scd who has multiple alloantibodies with difficulty in obtaining compatible blood, in order to highlight the importance and clinical consequences of this complication and suggest a possible management approach methods: an -years-old female patient with scd presented to our hospital with hemoglobin level of g/dl secondary to acute splenic sequestration. she had a history of multiple previous admissions and many previous rbc transfusions. blood grouping and pre-transfusion compatibility testing were performed in addition to phenotyping of the patient's red cells. screening was done using column agglutination technique by automated machine (ortho; usa) and antibody identification was performed manually using commercial cells identification panel. phenotyping for the patient was done using haemagglutination technique with mono-specific anti sera (bio-rad; switzerland). results: the patient was of group o rhd (positive). antibody screening was positive and antibody identification revealed probable anti-e and anti-fya with possible development of anti-k allo-antibodies, in addition to recent development of autoantibodies; giving pan-positive reactivity with the identification panels. phenotyping of the patient's rbcs was found to be r r and k-negative. other masked allo-antibodies of undefined specificities were suspected and no compatible blood was found. the clinical condition warranted a blood transfusion, so least incompatible phenotypically matched rbc unit was released. the patient developed acute hemolytic transfusion reaction with drop of the hb level to . g/dl. despite screening hundreds of rbc units, no compatible units were identified, and no transfusion was given. the patient was managed conservatively using hydration, analgesics, hydroxyurea, erythropoietin, intravenous immune globulin (ivig), steroids, and rituximab. hb level increased to g/dl in weeks, and the patient was discharged from the hospital. the sample of the patient was sent to a reference lab (institut fur klinische chemie und laboratoriumsmedizin-regensburg -germany) for further investigations, clarifications and advice for compatible transfusion in case of need. the report of the reference lab revealed the development of additional anti-m and anti-s with confirmation of the presence of anti-fya, anti-k and warm auto-antibodies. phenotyping of rbcs was confirmed by molecular diagnostic testing done in the reference lab; as r r, k-neg. summary/conclusions: finding compatible blood may be extremely difficult in patients with scd who develop multiple alloantibodies. it is therefore essential to perform an initial extended red cell phenotyping for the patients at diagnosis and to have on shelf ready phenotyped blood units for issuing to the patients, to minimize allo-immunization. transfusion may occasionally be avoided in allo-immunized patients, utilizing alternative options of treatment and reducing the risk of serious complications such as hemolytic transfusion reactions. background: red blood cell (rbc) antigens that are present on less than % of most populations are known as low incidence antigens and those present on more than % are known has high incidence antigens. the mns blood group system consists of antigens carried on glycophorin a (gpa), glycophorin b (gpb) or on hybrids of these glycophorins. there are low incidence and high incidence antigens in the mns blood group system. an individual that is homozygous for gp.mur will be negative for the high incidence jenu (mns ) antigen. anti-jenu was first described in a thai patient with thalassemia where only compatible units were found following screening of units. the jenu negative phenotype is a rare phenotype with an estimated frequency of . %. a male patient with a history of previous transfusion presented with an anti-e and a weak auto antibody with no apparent specificity. a donor unit selected for cross match (group o rhd positive, c+e-c-e+, k-) was incompatible with a reaction grade of + by column agglutination technology. the patient's sample and donor unit were referred to the red cell reference laboratory for investigation for a possible antibody to a low incidence antigen. aims: we aim to characterize the phenotype of the incompatible donor unit. methods: standard serological procedures were used to identify the antibody specificities in the patient's sample. blood group phenotyping of the patient and donor was performed by standard serological procedures. genotyping and zygosity testing was performed using polymerase chain reaction (pcr) high-resolution melting (hrm) assay. gp.mur is a gp(b-a-b) hybrid glycophorin resulting from a gene conversion event between gypa and gypb . this disruption to gpb impacts s expression. the donor was negative with anti-s moab (albaclone), positive with anti-s polyclonal (immulab) and negative with anti-s monoclonal antibody (immulab). this s and s phenotype was consistent with the previously reported examples of gp.mur homozygote jenu negative individuals. molecular testing was consistent with serology supporting gp.mur homozygosity and jenu negative phenotype. summary/conclusions: this donor has been added to our rare donor panel and their red cell donations are cryopreserved for future use in our rare donor frozen inventory. there is limited anti-jenu antiserum available to confirm the jenu negative phenotype. we currently rely on the serological profile of red cells presenting with the gp.mur phenotype, s negative and the discrepant s phenotyping to identify jenu negative donors. this case has highlighted the importance of following up unexplained serological incompatibilities. the development of a monoclonal antibody directed against jenu antigen would provide an opportunity to screen for suitable donors for this rare phenotype. background: molecules expressed on tumor cells are a target of interest for drug development by the use of monoclonal antibodies or blocking proteins. however these drugs have the potential to interfere in pretransfusion testing when the target molecule such as cd is also expressed on red blood cells (rbcs). recently, many drugs targeting cd have been developed but appropriate mitigation strategies and approach to selecting rbcs for safe transfusion is still an obstacle. aims: we describe a case of delayed hemolytic transfusion reaction (dhtr) by anti-jk a in a patient treated previously with cd targeted high affinity sirpa fusion protein alx . methods: a -year-old woman diagnosed with nasal cavity squamous cell carcinoma was enrolled in an alx clinical trial. her blood type was group ab, rhd positive, and the antibody screening test was negative for the past months. she had no previous transfusion history during the past two years. after two infusions of alx , two units of apheresis platelets were requested for transfusion. the blood bank noticed that the antibody screening was positive and further investigation was proceeded. results: antibody screening showed trace positivity in both panel cells (i & ii) at room temperature (rt) and °c albumin phase, and + at anti-human globulin (ahg) phase by tube method. the auto control was negative at rt and °c albumin phase, but + at ahg phase. antibody screening ( cells) and identification ( cells) all showed + at ahg phase using gel cards. direct antiglobulin test was + for anti-igg and + for anti-c d using gel cards. two units of rbcs were requested for transfusion after hemoglobin decrease to . g/dl. rbc genotyping was unavailable at the moment. as her previous antibody screening was negative (anti-jk a not detectable), e-, c-, fy b -rbcs were given as a second best option, considering the phenotype distribution of major blood groups in the korean population. the hemoglobin level was well sustained between . - . g/dl but it decreased again to . g/dl twenty days after rbc transfusion. further laboratory investigation was consistent with a dhtr. the patient was no longer being given alx , and antibody screening and dat decreased to - + reactivity. we presumed that antigen typing results would be reliable after chloroquine dissociation and cell washing using antisera that did not require ahg for testing. serologic phenotyping showed that the patient's cells were c+, e+, c+, e+, jk a -, jk b +, fy a +, fy b -, s-, s+, m+, n + . antibody identification using papainized panel cells revealed anti-jk a antibody. we concluded that the dhtr was due to anti-jk a , and jk a -, fy b -, s-rbcs were issued for further transfusion requests. the patient's hemoglobin level recovered to . g/ dl. the patient's genotype was later identified to be the same as serologic typing. summary/conclusions: communication with the physician and blood bank to perform adequate pretransfusion testing before administration of drugs targeted to cd is important to achieve safe transfusion for patients. serologic phenotyping using antisera which do not require ahg for testing can be used as a second option when genotyping is unavailable in a timely manner. background: transfusion is still a key treatment for sickle cell disease (scd) patients. as a result, these patients are much more exposed to transfusions' risks, the most feared one being a delayed hemolytic transfusion reaction (dhtr). we investigated a female scd pediatric patient with no known antibody, who was referred to us for a suspicion of two dhtrs. three transfusion episodes were reported (a total of four units collected from four donors). for the last transfusion, a premedication with rituximab was done. the patient was planned to undergo a bone marrow transplant with her brother as her donor. aims: to describe the molecular and serological workups needed to investigate a dhtr in a scd patient. methods: antibody identification and crossmatches were performed by iat gel testing with red blood cells/panels, which were used raw, papain-treated and trypsintreated. rbcs' phenotypes were determined by conventional techniques. semi-quantitative phenotypes were conducted by serial dilutions with a monoclonal anti-jk a (ms /seraclone â ). dna was extracted using the magna pure compact instrument (roche). sequencing of jk exons - was carried out by in-house techniques. results: the antibody identification showed a very weak anti-jk a , which was only reactive on papain-treated rbcs. autologous control was also only positive in this technique. dat and the eluate were negative. as the patient had recently been transfused (less than four months earlier), on this first sample we were neither able to perform autologous adsorptions, nor verify her jk a /jk b phenotypes. in order to rule out the imputability of an anti-lfa in the dhtr outcome, crossmatches with her donors' rbcs were undertaken. three out of the four donors were tested. apart from the anti-jk a reactivity, none of them was reactive. because the patient had previously been phenotyped as jk(a+b+), her jk gene was sequenced. her genotype was determined as jk* ( a, a, a, g)/jk* . to confirm this jk a variant allele, a family study was conducted. all her siblings were found to harbor the same genotype. her mother's and father's genotypes were jk* ( a, a, a, g)/ jk* and jk* /jk* , respectively. subsequently, autologous adsorptions were performed, which proved the anti-jk a to be an autoantibody. considering the weakness of this antibody, internal controls were used, in order to evaluate a possible dilution effect of this technique. finally, serial dilutions with the anti-jk a reagent showed a weakened jk a expression encoded by the jk* ( a, a, a, g) variant allele. this finding is consistent with the fact that the crossmatches between the proband's serum and her brother's rbcs were weaker than those performed with (jka+b+) rbcs. summary/conclusions: about a third of dhtrs are reported to happen in patients with no previous history of immunization. performing sensitive serological techniques in order to identify antibodies is necessary to select the most appropriate units. molecular work and extra serological testing can be useful to determine whether an antibody is an allo or autoantibody. even though in this case the anti-jk a was the only antibody identified, because it was proven to be an autoantibody, it is difficult to conclude if it was the cause of the dhtr. nevertheless, jk(a-b+) blood was issued, and no adverse events have been reported. luckily, the patient's bone marrow donor harbors the same variant allele. background: according to the aabb, a pre-transfusion sample must be obtained within days of transfusion if a patient has been transfused or pregnant in the preceding months. despite this safeguard, high risk patients (i.e. those recently transfused with a history of pregnancy or transfusion) may develop antibody during this day window. to avoid issuing incompatible red blood cells (rbcs) to these patients, a new antibody screen (abs) sample should be drawn and tested shortly before anticipated transfusion. aims: we report a case of a y/o man who presented to the ed (hospital day , hd ) with a post-fall intracranial hemorrhage and multiple fractures. anti-e and anti-jka were identified after admission on a new specimen prior to current specimen expiration (< days). methods: specimen # (s ) was sent on hd for type & abs (t&s) and crossmatch (xm) of rbcs. abs and immediate spin xm were negative; there was no patient history. by hd , he had negative t&s specimens (hd : s ; hd : s & ; hd : s ) and had been transfused rbcs (hd : ; hd : ) via electronic xm (exm). at hr on hd , rbcs were requested and could have been issued via exm since s was not expiring until midnight. however, given recent transfusions, bb staff first called the patient's nurse to review history. patient was uncommunicative, but had scars suggesting past trauma or surgery. s was requested and received at hr. results: s showed anti-e and anti-jk a in plasma and eluate. his hemoglobin/hematocrit (h/h) decreased from . ( . - . g/dl)/ . ( . - . %) on hd to . / . on hd . during this period, he underwent several surgeries without unexpected bleeding, documented jaundice or dark urine. two e-jk(a-) rbcs were transfused on hd , which he tolerated well with an increase of hemoglobin from . g/dl to . g/ dl. he did well post transfusion with stable h/h between . / . . to . / . . he was discharged on hd . repeat abs on s was negative. of the rbcs transfused before s , one was e+ and four jk(a+). the family reported that he was injured years prior and had been admitted to hospitals, but was unaware of transfusion. hospital # (h ) reported admissions years ago ( rbcs transfused) and years ago; all abs were negative. h admission was years ago with positive abs and inconclusive workup. h admission years ago showed negative abs. summary/conclusions: the patient developed a significant antibody response in less than days from the specimen collection, likely a secondary immune response to sensitization from a transfusion years earlier. a new specimen was requested prior to transfusion even though the existing sample (which was abs negative) had not expired. this approach identified new antibodies, preventing transfusion of incompatible rbcs, and a potentially serious hemolytic transfusion reaction. this case suggests that for high-risk patients, abs more frequently than every days may be beneficial. it is important to increase clinicians' and laboratorians' awareness of this issue. background: red cells with partial d antigen have historically been classified as such, based on the fact that the red cells type as d positive, but individuals make anti-d antibody when exposed to conventional d antigen. a definitive confirmation of the variant of d antigen is obtained after the rh d genotyping. aims: to present a case study of the patient's alloimmunisation with the present d partial antigen type dnb, most likely on previously received transfusions. methods: the patient's pretransfusion testing included the determination of the abo blood group and rhd type (id card diaclon abo/d dv+, dv-, reverse grouping, monoclonal antibodies, gel method), antiglobulin crossmatch, additional phenotyping (gel and tube methods), antibody screening, identification of the specificity of irregular anti-erythrocyte antibodies by commercially available red cell panels (id dia-panel bio rad gel method, panocell immucor, tube method) through an indirect antiglobulin test (iat) and enzymes. after routine rhd typing we continued further characterisation of the rhd antigen by serologic assay (bio-rad id-partial rhd typing),and finally by rhd antigen molecular genotyping (fluogene method on fluo vista machine). results: our patient is a year old woman with a diagnosis of tu mammae who was preparing for total mastectomy surgery. she had a history of blood transfusions twenty years ago, and she also had two births. the blood group typing was: o, ccdee, k-, fy (a-b +), jk (a+b +), ss, mn, le (a+b -). the agglutination reactions that we tested with anti d serums were strong ( +). the compatibility test with rhd positive donated blood units was positive. the presence of anti-d and anti-fya antibodies in the serum of the patient was determined. we prepared one compatible blood unit, rhd negative and fya negative, for a surgery. interpretation of the id-partial rh d typing set indicated that this is a diii category of d partial antigen. a sample of blood of our patient was sent to the blood transfusion institute of serbia, where molecular typing of d antigen was performed and the presence of partial form of antigen d, dnb type, was found. summary/conclusions: rhd positive patients or donors with anti-d antibody presents in their serum should be tested for d genotyping. the recommendation for further transfusions of our patient with dnb d partial and her alloimmunisation is to prepare d negative, fya negative erythrocytic blood components, and as a possible blood donor it would be labeled as rh d positive. background: the jr blood group system consists of jr a (jr ), a high frequency antigen expressed by the abcg gene. the individuals with jr(a-) phenotype are mainly found in the japanese population and may develop anti-jr a when stimulated by blood transfusion or pregnancy. anti-jr a is a dangerous antibody for pregnancy, but also could cause mild or moderate neonatal jaundice. aims: to conduct the antibody specificity identification of the high frequency antibody in a pregnant woman with history of pregnancy but no transfusion. methods: abo, rhd and some special blood group antigens were identified by tube method in saline. antibody screening and blood group specific antibody identification were performed by indirect antiglobulin test (iat) in gel column. the reagent cells treated with trypsin, chymotrypsin and papain, were used to test the antiserum to obtain the characteristic of antibody reaction. the antibody titer in the patient's serum was detected. dna sample was extracted and exons and adjacent intronic sequence of the abcg gene were sequenced. the sample of one family member was collected for testing. results: the blood groups of the patient were b, rhd(+), lu b (+) and kp b (+). the negative reaction of the serum reacted with all reagent cells were tested in saline, but positive ( +) in iat test, while the self-control was negative. the antiserums reacted strongly ( + in iat test in gel card) with the papain-treated cells, but kept the same reaction strength ( +) with trypsin-and chymotrypsin-treated cells, which indicated the possible existence of anti-jr a . the titer of igg antibody in serum was . in cross matching test, the red blood cell of the patient's brother with the same abo and rhd blood group with the patient was successfully matched with the serum of the patient. the sequencing analysis of the abcg gene in the patient and her brother revealed one homozygous nonsense mutation in exon (c. c>t, p.gln x). after the delivery of the pregnant women, no pathological jaundice was seen in the newborn. summary/conclusions: in the condition of the anti-jr a reagent was unavailable for the identification of jr a antigen in the patient, having an indication with anti-jr a by serological test, the alternative genotyping method was used. the most common silencing jr allele reported in asian population, especially in japanese population, was identified to indicate jr(a-) phenotype. immunohemotherapy, centro hospitalar vila nova de gaia/espinho, vila nova de gaia, portugal background: if the investigation of irregular/unexpected antibodies reveals a pattern in which all or most screen and panel cells are positive, with reactions in the same phase and with the same strength, along with a negative autocontrol, an irregular antibody to a high-prevalence antigen may be suspected. high-prevalence antigens are those that are present in almost all individuals ( % or more). fortunately, because these antigens do occur so frequently, it is not common to find a patient with an antibody to one of them. however, when it happens, it may become a troubling situation. aims: clinical case report of panagglutination in assessment of irregular antibodies. methods: collection of clinical data in scl ınico â and sibas â applications. results: woman, years old, o rhd+, previously transfused with red blood cells concentrates in , was proposed to a correction surgery of a periprosthetic hip fracture. pretransfusion serologic tests were requested and irregular antibodies were detected ( + in all the screening cells). in order to identify the specificity of the antibody, a panel of cells was tested; the result was considered inconclusive, due to positive reactions ( +) with all test cells in liss/coombs and atypical positivity with dragging in all cells in enzymatic environment. autocontrol and direct antiglobulin test were negative. it was decided to send two blood samples to the reference laboratory for a more complete immunohematological study. compatibilization of red blood cells to this patient was also requested. during the waiting period, haematopoiesis was optimized. although the patient did not present anaemia at admission, the analytical study revealed iron deficiency; therefore, supplementation with intravenous iron was performed. the reference laboratory also obtained a panreactive panel ( + with all cells) in liss/coombs and weak positivity in papain. after allo-adsorption, the search for irregular antibodies was negative. an anti-yt a , apparently without clinical significance (negative igg and igg ) was then identified. transfusion was not needed either during or after the surgery, with a good recovery of the haemoglobin value in the postoperative period. summary/conclusions: yt a , which belongs to cartwright system, is a high-prevalence antigen in all populations. anti-yt a , an igg antibody stimulated by pregnancy or transfusion, is not as uncommon as we may think, which suggests that it is reasonably immunogenic. these antibodies are not generally considered clinically significant, but there are reported cases of acute and delayed haemolytic transfusion reactions in which anti-yt a has been implicated. therefore, although the described pattern of panagglutination in assessment of irregular antibodies may suggest the presence of an alloantibody directed against a highfrequency antigen, it is very important to confirm that hypothesis, recurring to a reference laboratory if necessary, to identify the antibody and to determine its clinical relevance. even if the identified antibody is associated with rare haemolytic transfusion reactions, it is crucial to optimize haematopoiesis when it is not an emergent procedure, in order to minimize transfusion and its associated risks. both for emergent and elective procedures, the creation of a national database of patients with already identified irregular antibodies would facilitate the administration of red cells concentrates without the implicated antigen. aims: to investigate the frequency and explore the genomic characterization of jk (a-b-) phenotype in blood donors in harbin, china. methods: all samples were screened for jk(a-b-) phenotype using a direct urea lysis test. and the results were confirmed with by iat using anti-jka and anti-jkb with a standard tube test. additionally, polymerase chain reaction amplification and sequence analysis of the jk gene were performed. results: from blood samples, four donors with jk (a-b-) were selected, at a frequency of . %. among these four samples available for sequencing jk gene, a total of two genotypes were discovered: heterozygote of ivs - g>a combining with heterozygote of g>a (gly glu) and heterozygote of g>a (gly glu) combining with heterozygote of c>t(thr met). summary/conclusions: the frequency of jk(a-b-) phenotype in blood donors in harbin area was lower than the reported data from the populations in other areas of china and in finland, but higher than that in japan. ivs - g>a, g>a and c>t were common mutations in the before reports, while g>a was reported first time. in addition, it is an effective measure which establish the jk(a-b-) phenotype donors in this region, to solve the blood transfusion problem in patients with anti-jk . background: blood types, indicating the type of blood group antigen expressed in the red blood cells, is determined by the type of allele at the blood group gene locus. therefore, when allele frequency of each blood group gene is determined, it is possible to predict the frequency of a specific blood type donor with a homozygous allele. it is also possible to estimate the proportion of donors within a particular blood type through combination of specific alleles. and because the ratio of blood group allele differs between ethnicity and race, this can be used as basic data for population genetics and anthropology. therefore, we present a study that examined the allele frequencies of blood group systems in the korean population through blood group genotyping. aims: the purpose of this study is to determine the frequencies of blood group alleles in the korean population, to predict the proportion of homozygous donors, and to obtain the basic data of population genetics. methods: , blood donors from age to were recruited at korean red cross blood centers located nationwide. acquired samples were examined by blood group genotyping methods using the rbc genotyping system id core xt (progenika biopharma). for each donor, genotypes of blood group systems, excluding abo and rhd, were identified. calculation of the frequencies of blood group alleles in the korean population was done. results: we conducted molecular genotyping of the rhce, kell, kidd, duffy, mnss, diego, dombrock, colton, cartwright, and lutheran blood group systems. the allele frequencies of these blood group systems in the korean population were estimated as follows. -rhce*ce . %, rhce*ce . %, rhce*ce . %, rhce*ce . % -kel*k_kpb_jsb allele % -jk*a allele . %, jk*b allele . %, jk*b_null allele . % -fy*a allele . %, fy*b allele . % -gypa*m allele . %, gypa*n allele . % -gypb*s allele . %, gypb*s allele . %, gypb*mur allele . % -di*a allele . %, di*b allele . % -do*a allele . %, do*b allele . % -co*a allele % -yt*a allele % -lu*b allele % summary/conclusions: the significance of this study is accumulation of data on the allele frequencies of blood group genes through highly accurate genotyping method in the east asia region. this enables the prediction of the proportion of donors with a combination of specific blood group alleles in the korean population, which accounts for a decent percentage of the population in this region. background: in donors from arabian countries only little is known about blood groups other than abo and rhesus. during the last years increased migration to central europe has put a focus on the question how to guarantee blood supply for patients from these countries, particularly because hemoglobinopathies with the need of regular blood support are more frequent in patients from that region. aims: blood group allele frequencies should be determined in individuals from syria, other arabian countries, and iran by molecular typing. methods: as most blood groups are defined by single nucleotide polymorphisms (snps) we introduced a maldi-tof ms assay to detect alleles encoding blood groups including kk, fy (a/b), fy null , c w , jk(a/b), jo(a+/a-), lu(a/b), lu ( / ), ss, do (a/b), co(a/b), in(a/b), js(a/b), kp(a/b), rhce*c. c>g, and rhce*c. c>g. additional blood groups and polymorphisms like yt(a/b), s-s-u-, vel null , co null and rhce*c. g>t were tested by pcr-ssp. a total of probands including individuals from syria, from iran, from the arabian peninsula and from northern african countries were included. results: % of the donors were homozygous for the fy null (fy*- t>c, fy* n. ) mutation, . % carried the heterozygous mutation. . % of the syrian probands were heterozygous for the do* c>t mutation (both, do*jo and do*jo ; jo(a+/ a-)) that is virtually unknown in caucasian donors. . % of the syrian donors heterozygously carried the kel* . allele coding for js(a) (phenotype js(a+/ b+)) that is very rare in caucasians. however, no homozygous kel* . carriers were identified. . % of the syrian and . % of all donors were negative for yt*a, which is definitely more frequent than in europeans. one donor from northern africa homozygously carried the gypb*c. c>g, intron + g mutation, inducing the s-u+ w phenotype. . % of all and . % of northern african donors were heterozygous for the rhce*c. c>g substitution, . % of the syrian donors carried rhce*c. c>g (heterozygously) and . % of all donors were heterozygous for rhce* g>t. heterozygosity for vel deficiency (vel*- ) was detected in individuals ( %; of them from syria) whereas only one syrian donor carried the homozygous mutation. none of the donors carried the aqp *c. delg (co* n. ) mutation that induces the co null phenotype. summary/conclusions: the study provides a first overview on a number of different blood group alleles in blood donors from arabian countries. some blood group alleles that largely are lacking in europeans but had been described in african individuals are present in arabian populations at a somewhat lower frequency. in single cases it could be challenging to provide immunized arabian patients with compatible blood. methods: three unrelated individuals ( blood donors and one pregnant woman) of polish origin who were typed as ab group with a very weak a antigen and normal b antigen expression were subjected to extended abo typing. in one case family studies were performed (blood samples from donor's mother, father and sister). sequencing analysis of this donor dna was performed three times (from two blood samples and buccal swab). serologic investigations were performed with standard methods: /gel cards diaclon id abo/d (anti-a: clone a , anti-b: clone g / , anti-a,b: clone es , es + birma + es ; bio-rad) and diaclon id abd-confirmation for donors (anti-a: clone m / = la- ; bio-rad); /tube techniques with: anti-a (birma ; a- h , a s.pa m , c. d ), anti-b (lb- , b- f , c. a ). genotyping was determined by rbc fluogene abo basic kit (inno-train, germany) and by sequencing of + . -kb site of abo gene to cover sequences ranging from the end of intron to utr of the abo gene. additionally sequence of exon of the abo gene was analyzed. results: abo typing showed normal b and a very weak a antigens on rbcs of all three individuals ( blood donors and one pregnant woman). the a antigen was detected by tube technique only using anti-a clones: birma ( + to +), a- h ( + to +) and c. d (weak+ to +); negative reaction of a antigen typing by gel cards was observed. the sera of all individuals contained anti-a antibodies. commercial pcr-ssp kit revealed three heterozygous a/b genotypes (absence of delc typical for abo*a alleles). in all these individuals abo sequencing of . -kb fragment confirmed the heterozygous genotype with polymorphisms characteristic for abo*b. allele ( a>g; c>g; c>t; g>a; c>a; g>c; g>a) and detected a novel abo*a allele sequence with duplication-based insertion of bp after position (abo*a c.dup _ ; gcaggacgtgtccatgcgccg). as a consequence, the online protein translation predicts an in-frame duplication of seven amino acids after codon (p.dup_ _ qdvsmrr), with synonymous change of the repeated codon (cgc>cgg) and (cgg>cgc) but both coding arginine (r). inheritance of abo*a c.dup _ allele was confirmed by family studies of one donor: his father and sister had a/b genotype associated with normal a and b antigens expression; his mother had normal a antigen expression. she carried abo*a . allele and the same abo*a c.dup _ allele as a son. summary/conclusions: a novel a weak allele at the abo gene detected in three unrelated polish individuals is an in-frame insertion of seven amino acids to the wild-type glycosyltransferase a. the stability of the encoded protein may be affected causing the weak a phenotype. the inheritance of this mutation was confirmed in the family studies. background: since the cloning in of cdna corresponding to mrna transcribed at the blood group abo locus, polymorphisms and phenotype-genotype correlations have been reported by many investigators. although many subgroups have been explained at the genetic level, unresolved samples are still encountered in clinical practice. we report here the result of an abo investigation of a sample from a swedish blood donor that showed a very weak agglutination of rbcs with anti-a in routine forward typing. aims: to elucidate the genetic basis of the apparent weak a subgroup. methods: routine abo genotyping by pcr-asp and pcr-rflp including pcrbased analysis of the upstream cbf/nf-y-binding enhancer region was carried out. further genetic analysis was performed by dna sequencing of abo exons - (including base pairs of the adjacent introns) and the proximal promoter. flow cytometric testing of rbcs was performed with monoclonal anti-a, anti-b and anti-h. results: the weak agglutination of erythrocytes with anti-a was accompanied by the expected lack of anti-a and anti-a in plasma. abo genotyping gave the genotype abo*a . /o . usually consistent with normal expression of a antigen. enhancer analysis resulted in an amplification product corresponding to the expected single cbf/nf-y binding motif. flow cytometric testing of the sample showed a antigen expression with an almost chimeric pattern where the majority of the cells (approximately %) expressed the a antigen at a very low level, marginally distinguishable from the group o control. the remaining approximately % of the cells displayed an a antigen level ranging from normal to very weak. genomic abo sequencing showed an abo*a . -like allele except for a novel mutation located in intron , c. + g. the o allele had an additional snp, c. g>a, consistent with the abo*o . allele variant summary/conclusions: a previously unreported variant, c. + a>g, likely effecting the -donor splice site of intron was found in an a weak sample. this type of mutations is expected to decrease mrna stability and/or cause skipping of the preceding exon in the mrna. however, small amounts of full-length enzyme might still be made, being able to give rise to the weak a antigen expression seen in this individual. interestingly, this mutation is very similar to the genetic variant underlying the weak a subgroup a finn . in this case, however, the c. + a>g mutation is located in the -end of intron and is predicted to cause partial skipping of exon . strikingly, the a finn phenotype also results in a pseudochimeric pattern by flow cytometry but with only approximately % positively staining erythrocytes. due to the well documented lack of a-allele-derived mrna in peripheral blood, further transcript studies could not be undertaken. further studies are needed to investigate the exact mechanisms underlying the pseudochimeric pattern observed by flow cytometry in these two interesting genotypes/phenotypes abstract withdrawn. background: abo is the clinically most relevant blood group system in transfusion and transplantation medicine. abo genotyping is potentially useful in clarifying serologic blood grouping discrepancies. this scenario includes inherited subgroups alleles, temporary acquired variant abo phenotypes in disease or pregnancy, and chimerism due to exchange of progenitor cells early in fetal life or after blood progenitor cell transplantation. aims: to investigate the molecular basis for abo discrepancies detected in clinical samples, including donors and patients, sent to our reference laboratory during the past years. methods: if routine abo grouping showed weak agglutination or forward vs reverse typing discrepancy, further abo typing studies were performed manually. adsorption-elution tests were also performed in some cases with polyclonal anti-a and anti-b to confirm whether a or b antigens were weakly expressed on the rbcs membrane. a pcr approach using sequence specific primers for a , b, o and o alleles was used for initial genotype determination. the full abo coding region was analysed as previously described in selected samples for which abo discrepancy was still unexplained. allele specific fragments spanning exon , intron and exon were amplified using a forward primer targeting the g nucleotide (to exclude o alleles amplification) in combination with either b, a or a generic reverse primer. analysis was carried out by sanger sequencing. results: a total of samples with suspected inherited abo subgroup alleles were selected for further molecular studies by sequence analysis. a subgroup alleles: in out of samples with suspected a subgroup alleles, the c. insg insertion was detected corresponding to the abo*ael. allele. the abo*aw . - variant, a hybrid a -o v allele, was found in cases. in case we found the c. g>c change, previously reported associated with weak a antigen expression. finally, a novel c. c>g change was detected in an a allele. b(a) or cis-ab suspected alleles: the abo*b(a) variant carrying the c. a>g change was found in of samples with bo genotype but a weak antigen expression. in the remaining cases, a consensus b allele was detected, thus pointing to a potential chimerism as the cause of the results observed in abo grouping. finally, we have identified an abo*b . allele carrying the nucleotidic change c. a>g in the context of an abo phenotype vs genotype discrepancy. summary/conclusions: the sanger sequencing approach applied in this study have proved to be informative and helpful to determine the molecular basis of abo grouping discrepancies with suspected inherited subgroups. we found mutations, within exon of the abo gene, in out of samples, including novel alleles. chimerism was suspected in cases of a antigen expression in samples with b o genetic background carrying an apparent normal b allele. we are evaluating at the moment a deep sequencing approach by next generation sequencing to determine the presence of a small amount of a minor allele in the presence of a large surplus of the other two alleles. background: recently, the multiple pregnancy rate has been increasing due to advances in artificial fertilization including in vitro fertilization-embryo transfer. most dizygotic twins have dichorionic placenta, but % of them share the placenta. monochorionic dizygotic twins can have blood chimerism, leading to double rbc populations in routine abo serologic typing. recently, more sensitive and objective column agglutination tests with automated systems are being widely used. therefore, blood chimerisms in dizygotic twins can be detected more easily by routine abo blood typing. aims: we report congenital blood chimerism in monochorionic dizygotic twins of triplets, found incidentally during abo serological testing and confirmed by abo genotyping and str marker analysis. methods: a -year-old male (one of triplets) was admitted to the hospital for medical checkup. he did not have any history of transfusion or bone marrow transplantation. routine abo blood grouping test was performed using automated blood bank system ih- ; however, it showed abo discrepancy. the red blood cells showed double cell populations in a gel column with anti-a and anti-b. we carried out abo genotyping both from the blood and from a buccal swab. for the further evaluation, we performed abo serologic testing, abo genotyping, and str marker analysis in his family members. results: among the triplets, blood chimerism was demonstrated in the patient and his brother. they both showed a b phenotypes in the serologic test and tri-allelic abo genotypes in the blood, a /b /o . however, in buccal swabs, the patient showed a /o and his brother showed b /o . other members of the family (father, mother, and dizygotic sister) had regular abo blood types in the serologic test. we performed str analysis in the triplets and parents. eleven loci (d s , d s , d s , csf po, th , d s , d s , d s , d s , d s , and fga) revealed more than one additional allele in the blood sample, apart from those in the buccal swabs. str marker analysis showed that his brother too had blood chimerism. summary/conclusions: we found blood chimerism in monochorionic dizygotic twins of triplets during routine abo blood typing, and this was confirmed by str analysis. as the application of assisted reproductive technology increases, the incidence of blood chimerism will also increase. blood chimerism can often create confusion during abo serologic typing and microchimerism can be overlooked in routine methods. therefore, it is helpful to use an automated blood bank system to improve sensitivity and blood chimerism should be considered if abo blood grouping reveals double populations. background: expression of abo transferase genes can be affected by genetic variants located within the coding sequence, at splice junctions, in the proximal promoter and in the intron enhancer. here we describe five new alleles with singlenucleotide substitutions found in samples with discrepant or unusual abo serology. aims: to resolve serological discrepancies or unusual serological findings in the abo blood group system by molecular methods, in particular by sanger sequencing. methods: forward and reverse abo phenotyping was performed by the gel or tube methods. genomic dna extracted from whole blood was pcr amplified to cover the entire abo coding sequence, splice junctions, proximal promoter and intron enhancer. amplification products were sanger sequenced directly or after cloning in a bacterial host. results: case # is a patient with an unclear abo phenotype: forward type b, reverse type ab. sequencing of genomic dna and cloned abo exon detected variant c. - t>g in heterozygosity on an otherwise common a allele, and in trans an abo*b. allele. case # is a caucasian donor with an abo discrepancy: forward type aweak/o, reverse type a. sequencing also detected variant c. - t>g in heterozygosity on an a background, and in trans an abo*o. . allele. given that this variant is located near the intron splice acceptor site, abo* - g transcripts are postulated to undergo altered splicing, leading to an aweak phenotype. case # is a prenatal sickle-cell disease patient with an abo discrepancy: forward type aweak, reverse type a. dna sequencing detected variants c. c>t (pro leu) and c. t>a (tyr asn), both in heterozygosity on an otherwise common a allele, with an abo*o. . allele in trans. thus, the data establish an association of allele abo* t, a with an aweak-like phenotype. case # is a donor with an abo typing discrepancy: forward type o, reverse type a. sequencing detected variant c. c>g (pro arg) in heterozygosity on an a background, and in trans an abo*o. allele. an interpretation of the data is that variant c. c>g weakens the activity of the a transferase, with allele abo*a ( g) encoding the aweak-like phenotype detected by serology. case # is a year-old patient with an abo discrepancy: forward type o, reverse type ab. sequencing of genomic dna and cloned abo exon detected variant c. g>c (gly ala) in heterozygosity on an a background, and in trans an abo*o. . allele. the serology and molecular results suggest that allele abo*a ( c) encodes a cisab weak phenotype. case # is a caucasian donor with an abo typing discrepancy: forward type o with a weak agglutination with anti-ab, reverse type o. dna sequencing detected variants c. g>a (glu lys) and c. g>a (asp asn), both in heterozygosity, in trans, and on a backgrounds. variant c. g>a by itself constitutes allele abo*a . . the phenotype encoded by abo* a is uncertain. summary/conclusions: molecular characterization of abo alleles can help in their future identification and discrepancy resolution. background: expression of abo transferase genes can be affected by genetic variants located within the coding sequence, at splice junctions, in the proximal promoter and in the intron enhancer. here we describe five new alleles with singlenucleotide substitutions found in samples with discrepant or unusual abo serology. aims: to resolve serological discrepancies or unusual serological findings in the abo blood group system by molecular methods, in particular by sanger sequencing. methods: forward and reverse abo phenotyping was performed by the gel or tube methods. genomic dna extracted from whole blood was pcr amplified to cover the entire abo coding sequence, splice junctions, proximal promoter and intron enhancer. amplification products were sanger sequenced directly or after cloning in a bacterial plasmid vector. results: case # is a year-old pregnant female with an abo typing discrepancy: forward type o, reverse type a. pcr-rflp predicted abo*a /abo*o . sequencing detected variant c. insg (val gly>fs ter) in heterozygosity on an otherwise common a allele, and in trans an abo*o. . allele. it is unclear how the early truncation of the a transferase encoded by allele abo* insg still allows for some residual enzyme activity, as suggested by the reverse a type. case # is a recently-transfused year-old black patient with an unresolved abo type. sequencing detected variant c. a>g (silent) in homozygosity and variant c. c>t (ala val) in heterozygosity, both on an o background, with an abo*b. allele in trans. although variants c. a>g and c. c>t are likely of no consequence to the abo phenotype of this patient, they are reported here as components of a new abo*o ( g, t) allele. case # is a year-old prenatal female with a rhd typing discrepancy. failure to yield an abo genotype on blood-chip (progenika), a genotyping microarray that interrogates polymorphic positions in rhd and abo, prompted dna sequencing. sequencing of genomic dna and cloned abo exon detected variant c. c>t (arg cys) in heterozygosity on an abo*b allele background, and in trans an abo*o. . allele. the phenotype encoded by allele abo*b( t) is predicted to be b, as evidenced by forward typing on immucor neo and reverse manual typing. case # is a prenatal black patient with an abo typing discrepancy: forward type o in gel, a + mixed field (mf) in tube. reverse type on a cells + in gel, / + in tube. sequencing of genomic dna and cloned pcr products covering exons - detected variant c. g>c (asp his) in heterozygosity, and in trans an abo*o. . allele. case # is the newborn baby of case # , with a forward type a + mf in gel, a + mf in tube. sequencing of the baby's dna detected variant c. g>c (asp his) in heterozygosity, and in trans an abo*b. allele. from these results it is inferred that the phenotype encoded by allele abo* c is a -like. case # is an year-old hispanic donor with an abo typing discrepancy: forward type a, reverse type o. sequencing of genomic dna and abo exons - and - detected variant c. c>t (gln ter) in heterozygosity, and in trans an abo*o. . allele. the truncation of the a transferase at such a relatively late position is consistent with the retention of some enzyme activity, explaining the forward a type encoded by allele abo* t. summary/conclusions: molecular characterization of abo alleles can help in their future identification and discrepancy resolution. background: expression of abo transferase genes can be affected by genetic variants located within the coding sequence, at splice junctions, in the proximal promoter and in the intron enhancer. variants reported to date in the intron enhancer include large deletions, small deletions and single-nucleotide substitutions. here we describe four new alleles with single-nucleotide substitutions found in samples with discrepant or unusual abo serology. aims: to resolve serological discrepancies or unusual serological findings in the abo blood group system by molecular methods, in particular by sanger sequencing. methods: forward and reverse abo phenotyping was performed by the gel or tube methods. adsorption-elution by the heat elution method and testing for h and a substances in saliva were performed by following the procedures in the aabb technical manual. genomic dna extracted from whole blood was pcr amplified to cover the entire abo coding sequence, splice junctions, proximal promoter and intron enhancer. amplification products were sanger sequenced directly or after cloning in a bacterial plasmid vector. background: inactive alleles of the fut could be decreased or aborted the activity of the fucosyltransferase, which results in to form the bombay or para-bombay phenotype with weak or no h antigen expression on erythrocytes. now many para-bombay individuals have been found in the chinese population. according to names for h blood group alleles v . of red cell immunogenetics and blood group terminology working group of the isbt, fut alleles were identified for bombay or para-bombay phenotype around the world. aims: the study was explored the distribution of fut alleles for the chinese individuals with para-bombay phenotype. methods: the samples were come from the blood donors or the patients. the a, b, h antigens were determined using conventional serological method according to the manufacture's instruction. the sequences of the full coding region for fut was amplified, then amplicon was purified with enzymes digestion and used as template for sequencing bidirectionally. all nucleotide sequences obtained were analyzed and compared with standard fut sequence. results: nineteen chinese individuals with para-bombay phenotype were identified. ten of them were the donors and nine individuals were come from the hospital. the rbcs had a very weak agglutination reaction with anti-h in the most of the individuals. fut homozygous mutations were found in the individuals and fut heterozygous changes were existed in individuals after bidirectionally sequencing. . %, . %, . %, . %, . %, . %, . %, . % respectively in the individuals with para-bombay phenotype. according to our previously reports, the fucosyltransferase activity of fut * n. (c. _ delag), fut * w. (c. c>t) and fut * w. (c. c>t) were abolished in vitro assay, while fut mrna levels of them had no effect compared with wild type. summary/conclusions: the fut mutations in the para-bombay individuals were various. the most common fut allele in the chinese individuals with para-bombay phenotype was fut * n. (c. _ delag). background: the regulatory mechanism of the abo gene is complicated and has been investigated extensively.variation in a antigen expression was recognized very early in the twentieth century and the a blood group was divided into a and a . later the a blood group was subdivided further based on characteristic reactivity with human polyclonal antisera, i.e., strength of reactivity and presence of mixed field agglutination; presence of anti-a , and whether a or h blood group substance was present in the saliva of secretor subjects. mutations critical for abo blood group phenotypes have predominantly been found in exons and of the abo gene, both of which encode the catalytic domain of abo glycosyltransferase. in our case report we show how mutation ranging from single nucleotide in the intron enhancer element can alter the efficacy of enzyme and alter antigen expression. aims: this study aims to investigate the molecular basis of discrepant results of abo forward/reverse typing in blood donor. methods: the abo typing was performed using tube technique and column agglutination tests (bio-rad, grifols). standard tests were completed with adsorption-elution study using o plasma as a source of anti-a, and with saliva testing for presence of a and h substances. we performed quality control for these methods. abo group genotyping was performed using pcr with sequence-specific primer by commercial kit (abo-variant; bag healthcare, lich, germany). pcr-amplified exons and intron enhancer were subject to bi-directional dna sequence analysis using standard sanger dideoxy chemistry. seqscape software (abi) was used to analyze sequence data by comparing the obtained sequence to a reference sequence from ncbi. results: standard serological forward tests identified blood group o, however, only anti-b iso-agglutinins were present. anti-a in adsorption-elution study was successfully adsorbed and eluted from the investigated cells. a and h substances were detected in saliva. abo genotyping using pcr-ssp indicated genotype o v/a . dna sequence analysis showed result abo*a ( + a), abo*o. . . the specimen was revealed as an a subgroup, probably a m with an unusual genetic variant in the intron region of the abo gene, the enhancer of the gene expression. summary/conclusions: we report the first case of abo*a ( + a), the mutation located in the enhancer region of gene expression in allele a, that causes discrepant results not only in abo forward/reverse typing but also in molecular blood grouping tests. based on our serological findings, this subgroup is considered as a m . background: a chimera is a single organism composed of cells with distinct phenotypes and/or genotypes. several different types of chimeras are described: artificial, twin and dispermic. the artificial chimerism can be seen following hematopoietic stem cell transplantation, or more transiently following blood transfusion. the second type may also be inherited most commonly through blood exchange in utero between twins. dispermic chimerism is induced by the fertilization of two maternal eggs with two spermatozoa and their fusion into one body. this one is also called tetra-gametic chimerism. in transfusion medicine, chimeras are often detected when mixed field reactivity is observed in abo/d typing or, less commonly, when phenotyping for other blood group antigens. aims: this investigation was prompted by finding a double population of erythrocytes in a surgery patient with no transfusion history. our aim was to investigate the chimera and determine the underlying abo genotype of this patient. methods: routine blood grouping was performed by column agglutination. separation of the double cell populations was performed by differential agglutination with igm anti-d (immuclone, anti-d fast igm, clone: d - , immucor). initial abo genotyping was performed by pcr-ssp (fluogene; inno-train diagnostik gmbh); further resolution was performed using in-house pcr-asp and pcr-rflp methods. next generation sequencing (monotype abo; omixon using illumina sequencing platform) and sanger sequencing analysis were also performed. identification of reference alleles was investigated by fragment analysis of short tandem repeats (str) polymorphisms. results: double population was found in column agglutination in tests with anti-a and anti-ab, and subsequently when typing for d and c antigens, with approximately % of o d+c+ cells. the patient's genotype was identified as abo*o. /*a by ce-certified pcr-ssp kit (fluogene). routine pcr-asp and pcr-rflp could not resolve the patient's genotype possible abo*a /*o genotype was detected by pcr-rflp, but the pcr-asp analysis gave an apparent abo*a homozygote result. sanger sequencing of abo exons and also gave anomalous reactions: no abo*a allele was detected. homozygosity for c. delg was observed as well as heterozygosity for c c/a. this result therefore suggests the patient's genotype is abo*o. /*o. . . next generation sequencing (omixon) revealed the same result. however, when pcr amplification of the cbf/nf-y enhancer vntr -region was performed, possible heterozygosity was observed, i.e. a weak band representing a single copy, and one representing copies of the enhancer region were present. presence of a single copy of the -bp cbf/nf-y enhancer vntr region is unique background: del is a very weak form of d antigen with low density expression of d antigen on the surface of red blood cell, which is generally typed as d-blood group as couldn't form agglutination in routine rhd blood group testing and could only be detected by the non-routine adsorption-elution test. in the east asian and southeast asian population, - % of the individuals with serologically apparent d-phenotype are not these with truly d-phenotype, but del phenotype, which is very rare in caucasian and black ethic groups. and the rhd* el. (rhd* a) is most prevalent (> %) in del people in these regions, so the del carried this allele was commonly known as "asia type" del. in previous studies, no alloanti-d was observed in a large cohort of chinese "asia type" del pregnant women with d+ fetus to indicate no occurrence of alloanti-d immunization against d+ red cell in "asia type" del individuals. aims: to conduct genotyping analysis in the chinese patients having serologically apparent d-phenotype simultaneous with alloanti-d to confirm the existence of the "asia type" individuals to produce alloanti-d or not. methods: from to , the blood sample of the patients or pregnant women identified with alloanti-d in our reference lab were collected. d antigen was confirmed again using the blend anti-d reagent (clone th- /ms- , igm/igg) by tube method in saline and indirect antiglobulin test (iat) in gel card. the zygosity of rhd gene was detected by hybrid rhesus box pcr with psti digestion. for the samples with d or dd genotypes obtained by rhd zygosity analysis, multiplex ligation-dependent probe amplification (mlpa) genotyping was conducted for rhd genotyping analysis. results: a total of serologically apparent d-chinese patients (female, n = ; male, n = ) with alloanti-d were identified. different titers of alloanti-d from : to : (≤ : , n = ; > : , n = ) were detected including few cases with mixed antibodies (anti-d mixed with anti-c, n = ; anti-d mixed anti-e, n = ). serological rhd typing confirmed the serologically apparent d-phenotype. rhd* n. / n. (homozygous rhd gene deletion) genotype was identified in majority of them ( / , . %) by rhd zygosity analysis, while rhd* n. / n. genotype (n = ) and rhd* n. / n. genotype (n = ) carried the rhd non-functional hybrid alleles were detected by mlpa. summary/conclusions: compared with the distribution of average % frequency of "asia type" del in serologically apparent dpopulation in guangzhou of china, no one case of "asia type" del was identified in the cohort of serologically apparent d-patients with alloanti-d in this study. this also provides evidence to confirm no occurrence of alloanti-d immunization in "asia type" del individuals. aims: a serologically rhd-negative donor was found to be rhd-positive in the routine rhd screen. to solve the discrepancy between serology and molecular screen, the sample was sequenced on dna and rna level. methods: phenotyping on id/iat-cards (bio-rad) was done using commercial anti-d antibodies. the adsorption-elution analysis was performed using an in-house pool of polyclonal anti-d antibodies. furthermore an antibody d-screen was performed (diagast). for rhd genotyping rh-type and partial d-type assays (bag health care) were carried out. the sample was further characterized by exon sequencing including flanking intronic regions. rna was extracted from whole blood, reverse transcribed and the cdna sequenced. for amplification and sequencing, both published (gassner, transfusion, ; legler, trans. med., ; richard, transfusion, ) and in-house primers were used. results: repeated phenotyping of the sample with commercial as well as, in-house anti-d antibodies confirmed the rhd negativity. in addition, the adsorption-elution analysis showed a negative result. however, genotyping, using commercially available kits, yielded a rhd positive result and no variants were detected. to investigate this discrepancy, all rhd exons were sequenced. the sequencing data revealed the mutation c. + delt in the splice donor site of exon . to confirm the effect of the splice site mutation on transcription, rna from a fresh whole blood sample was analysed. as a positive control, gypb was amplified and sequenced from the same cdna. wild-type gypb (mns ) was found. with rhd specific primers, no product could be amplified. summary/conclusions: we present a serologically rhd negative case, that was identified as rhd positive by standard commercial genotyping kits. sequencing revealed the new splice site mutation c. + delt. rna sequencing yielded no detectable product. the donor was classified as rhd negative. this case of a discrepant result between serology and genetics shows the importance of a profound and highly sophisticated genetic investigation of conflicting laboratory results. j stettler, s lejon crottet, h hustinx, c von arx, f still, j graber, c niederhauser and c henny interregional blood transfusion src berne ltd., berne, switzerland background: one of the most immunogenic and clinically significant blood group antigens in transfusion medicine is the rhd antigen. variant rhd phenotypes with weakened or absent antigen expression pose a challenge for rhd status assignment in blood donors. to ensure patient safety, it is necessary to fully characterize these variants at the molecular level. aims: samples from two donors were investigated in our laboratory due to discrepancy in rhd typing. methods: rh blood group phenotyping was done by standard serological column agglutination testing (id-system, biorad). further rhd characterization was performed by an anti-d antibody panel containing monoclonal antibodies (d-screen, diagast) and an adsorption-elution test using an in-house pool of polyclonal anti-d antibodies. molecular investigation was initially performed by ssp-pcr detecting common rhd variants (rbc-ready gene cde inno-train; rh-type bag health care). rhd sequencing was done on either dna or rna using published and inhouse primers for amplification and sequencing. results: by tube testing, the rbcs of donor were predicted to be rh:- ,- ,- , , . however, all ten exons of the rhd gene could be detected by routine genotyping. sequencing of rhd revealed a homozygous mutation c>g at position which is the second last nucleotide of exon and thus might have an influence on exon splicing. by cdna analysis a transcript with a correctly spliced exon was identified. the mutation c. c>g leads to the amino acid substitution t r located in the twelfth transmembrane domain of rhd using the model of flegel (transfus apher sci., ) as reference. adsorption-elution testing using a pool of polyclonal anti-d showed a weak positive reaction, re-classifying the donor as rhd positive. this novel allele, rhd* g, could thus be categorized as a del allele. serological results displayed an almost normal rhd antigen expression for donor . further serological determination of the rhd antigen with different antisera, however, showed a reaction pattern typically observed with a weak d variant. with commercial available kits no rhd variant could be detected. rhd sequencing revealed a novel homozygous mutation c. g>c in exon . this mutation causes a p.a p exchange in the sixth membrane-spanning domain of rhd. based on serological data, the donor is rhd positive and in case of transfusion the patient would be treated as rhd negative. summary/conclusions: here we report two novel rhd missense mutations c. c>g and c. g>c harbouring an amino acid substitution within a transmembrane segment. the c. c>g variation displayed an unusual low rhd antigen reactivity and would have been mistyped as rhd negative without extensive genotypic testing. molecular analysis of variant c. c>g suggests that the t r exchange causes a del phenotype rather than a miss splicing event. this was also confirmed by adsorption-elution testing. interestingly, variant c. g>c could only be detected due to comprehensive serological and genetically investigation. background: the rh blood group system is highly polymorphic and one of the most clinically relevant systems in transfusion. actually d antigen is of critical importance due to its involvement in hemolytic transfusion reaction and hemolytic disease of the fetus and newborn. rhd gene variants are common in africans and mostly related to partial d phenotype. aims: rhd gene sequence was investigated in two african brazilian samples. we further attempted to take advantage of combining the molecular data and the available in silico tools for the functional interpretation of the variations, in order to get insights into the clinical phenotype that may be predicted a priori from genotyping. methods: sample #id is a d-negative donor self-declared as african descent. sample #id is a patient with sickle cell disease (scd) typed as d-positive with anti-d in his serum. serologic d typing was determined by manual gel test and by microplate in an automated instrument. sample #id was also submitted to adsorption/elution test. after genomic dna extraction, all ten rhd exons and flanking intronic regions from sample #id were pcr-amplified with rhd-specific primers and analyzed by sanger sequencing. sample #id was investigated by next-generation sequencing on the miniseq platform (illumina) by using a previously published, custom (selected blood group genes) ampliseq panel. a reported three-dimensional ( d) structural model of the rhd-rhd-rhag heterotrimer was used to visualize the position of variations and predict their putative functional/clinical effect. results: in sample #id , a single nucleotide missense change, i.e. c. c>g in exon , was identified. this transversion is thought to replace a threonine by an arginine residue at amino acid position (p.thr arg) of the rhd protein. analysis in the d model clearly suggests a dramatic impact of the p.thr arg substitution occurring in a functionally-critical, conserved motif in terms of interhelix interaction, which is supposed to be highly deleterious to the stability of the protein, and potentially impairs totally its expression at the red blood cell plasma membrane. this predicted functional effect is definitely in accordance with the d-negative phenotype reported in sample #id . in sample #id , the single c. a>g transition was found in exon leading to a threonine-to-alanine substitution at amino acid position (p.thr ala). amino acid is located in rhd protein extracellular loop , and is thus thought to alter d antigen structure, resulting in a partial d phenotype. this hypothesis is in accordance with anti-d found in the serum of sample #id . summary/conclusions: for the past years, due to the advent of next-generation sequencing and the subsequent identification of numerous rare variants, bioinformatics prediction and modelling tools have evolved and currently help physicians in diagnostics, clinical management and genetic counselling. we took advantage of some of those in silico methods to predict retrospectively the effect of two novel variant rhd alleles, including one d-negative and one partial d alleles. although phenotype and clinical symptoms remain definitely the standard determinants to assess the effect of genetic variations, use of those approaches may soon become valuable for guiding subsequent investigations in immunohaematology. abstract withdrawn. alleles of the weak d type and diva cluster. in africans, the most frequent were typically associated with alleles of the weak d type (including dol and rhdpsi), diva and dau clusters with f v occurring in > % of alleles; in addition the key mutations of weak d type and dii and two inactivating mutations (c. _ inst and c. delg) not reported in rhb were among the first polymorphisms. in east asians, rhd( g>a) at . % was most frequent, followed by dfv, weak d type , dbo- , key mutations of diva and weak d type cluster as well as rhce-like substitutions and the mutations of weak d type , type , type , rhd(a v), dvl- , weak d and rhd(n s). weak d type and rhd(t r) were frequent in south asia but not elsewhere. summary/conclusions: data from tgp and gnomad add relevantly to the knowledge on rhd alleles; tgd discloses linked intron polymorphisms, gnomad frequency data not biased by the likelihood of serologic detection. current typing strategies usually start with serology later complemented by molecular typing. in the future, molecular methods will gain importance and frequent alleles currently not distinguished from "standard rhd" may need a rational transfusion strategy. in this respect, the high frequency of weak d type and type in europeans was surprising, might warrant confirmation by alternative methods and should trigger discussion on rational transfusion strategies for these alleles. consistent with an r haplotype and probable dc-. two siblings that were abo compatible including the dc-sibling were incompatible at iat phase. reactivity could be completely adsorbed from the serum using r r , r r , and rr rbcs indicating the antibody is probably a single specificity. the donor returned in and to continue autologous donations. the aim of this case study was to examine the genetic framework of the rhd and rhce genes and to characterize the rh epitope recognized by the antibody. aims: the donor returned in and to continue autologous donations. the aim of this case study was to examine the genetic framework of the rhd and rhce genes and to characterize the rh epitope recognized by the antibody. methods: serologic testing was performed by manual tube testing using ahg in the indirect antiglobulin phase. rbc phenotyping was performed by standard tube hemagglutination testing from edta anticoagulated blood. rhd and rhce exons were sequenced using genomic dna and standard sanger dideoxy method with the bigdye terminator v . cycle sequencing kit. sequence data was aligned to rhd_ng_ . . rhd zygosity was performed using pcr-rflp with mspi. background: according to recent findings in molecular immuno-hematology, rhd genotyping is strongly indicated in rhc+ and rhe+ donors classified in routine as d-negative. among these, one could find a non-negligible share of entirely new genetic alterations or even del alleles, which are often not identifiable with routine serological methods due to the low number of antigenic sites. aims: the present study reports the genotyping data of rhd on rhc+ and rhe+ caucasian donors classified serologically as d-negative, all enrolled by a single transfusion center in italy methods: rhd serological typing was carried out in microplate direct agglutination tests (iris, immucor) by using different anti-d igm clones (clone , dvi+: ldm +esd m; clone , dvi-: rum- , th ) and different anti-d igg clones (clone : ms ; clone : d e ). all donors with d-negative results (n = , divided into subjects with rhc+, with rhe+ and with both rhc+ and rhe+) were addressed to genotype analysis with rhd beadchip molecular test (immucor), pcr-ssp (bagene, inno-train) and/or rbc-fluogene (inno-train). the discrepant results between serology (d-neg) and molecular biology (wild-type or full-length rhd gene) were further investigated by bi-directional sequencing of the rhd coding regions. results: one-hundred donors have been analyzed retrospectively, as part of a pilot study. following the data obtained in this first phase, the analysis methods described above have been implemented in routine, allowing to include further donors, studied prospectively. in . % of donors (n = ), the molecular analyses showed the complete deletion of the rhd locus, while in cases ( . %) a genetic status was found with "non-deleted" rhd. over all, bi-directional sequencing on these donors revealed the presence of negative and weak-d variants. the list of rhd alleles we have identified at the molecular level is as follows: rhd* n. ( cases), rhd* n. ( ), rhd* n. ( ), rhd* n. ( ) , rhd* n. ( ), rhd* el. ( ), rhd* el. ( ), rhd* el. ( ), rhd* w. ( ) . moreover we found a donor with a lack of signal encompassing exons - of the rhd sequence (bioarray rhd beadchip), while additional cases are currently under investigation. summary/conclusions: our study confirms that a non-negligible number of caucasian subjects, classified serologically as d-negative, present rhd gene alterations that differ from the common total deletion. in line with the literature data, we also found a frequency of about in cases ( subjects out of ), in which a donor re-classification as d-positive (weak d type) was necessary. hence, a wider use of molecular typing methods is desirable in order to achieve the correct genetic characterization and the appropriate phenotypic classification of "apparently" d-negative donors. background: without evidence of abnormal serological d antigen expression there will be no quest for weak d, partial d or d variant on the red blood cells. according to our blood donor registry we found that out of serologically typed donors, . % were d+, . % d-and . % weak d. aims: to compare different weak serological reactions of the d antigen to the rhd genotyping. methods: molecular rhd typing using isolated dna and rbc-ready gene cde and rbc-ready gene d weak kits was performed in blood donors, who were serologically typed as weak d using monoclonal blended igm/igg and dvi-and dvi+ anti-d reagents by slide and microplate (mp) technique respectfully, as well as by the antiglobulin test (iat) in gel and with the set of monoclonal partial d typing reagents (biorad). in addition, rhccee phenotyping and genotyping was also performed. results: all of the donors with serologically weak reactions were confirmed to be weak d variants by genotyping except one donor whose iat was false positive due to rbc autoantibodies. the frequency of d variant genotypes was as follows: % weak d type , % weak d type , one donor was typed as weak d type and another one as weak d type . these weak d types were associated with different degrees of serologically determined weakness ranging from negative to weak positive reactions concerning slide and mp. all of them gave positive reaction ranging from + to + with iat, except for the weak d type with the score of < + which gave negative reaction by slide and mp and inconclusive result with the set of monoclonal anti-d reagents for partial d typing. the percentage of donors, who, at serological typing were only found to be d positive in the iat was %. one of the weak d type donors was negative with dvi-and positive with dvi+ reagent in the mp. the additional rh phenotype (genotype) was ccee in all of the donors except in the one who was genotyped as weak d type , as well as in the d negative donor, being ccee. summary/conclusions: further rhd genotyping is required to estimate the actual frequency of d variants in our blood donors. in practice, current serological methods are sufficient to detect almost all variant d phenotypes. there is a consensus that routine molecular d antigen screening in d negative donors in order to detect del variant when ddccee phenotyped red blood cell transfusion is practiced in all d negative patients does not seem to be cost-effective. background: rh null or rh mod -the so-called rh-deficiency phenotypes-are characterized by a null or severely reduced rh antigen expression (including d, c/c and e/ e), respectively. molecular genetic studies showed that these phenotypes are transmitted in an autosomal recessive manner. rh null phenotype originates from two different molecular events giving rise to the amorph type and the regulator type. the former is caused by homozygosity for silent genes at rhd and rhce loci, caused by inactivating mutations in rhce and deletion of rhd. on the other hand, the regulator rh null type as well as the rh mod phenotype are attributed to mutations in rhag gene when in homozygous state or when in heterozygosity with another rhag allele containing an inactivating mutation. a functional rhag is essential both for the correct rh complex assembly and rh antigen expression in the erythrocyte membrane. aims: the aim of this study was to investigate the molecular genetic basis of an argentinean proband with no detectable d, c, c, e and e antigens by standard serological techniques. methods: blood samples were collected from the proband, her parents and sister. the proband was a year-old young woman with parameters of hemolytic anemia: low hemoglobin level ( g/dl), reticulocytosis ( %), hyperbilirubinemia, increased ldh and marked spherocytosis. the d, c, c, e and e status was determined by standard serologic hemagglutination techniques using specific monoclonal antibodies. genomic dna was isolated using a modified salting-out method. dna samples were initially screened for the presence of intron and the untranslated region of the rhd gene using pcr strategies. rhc/c, and rhe/e alleles were studied by allele-specific pcrs to determine the rhce genotype. rhd zygosity was analyzed by pcr-rflp. rhd exon polymorphisms were studied by rhd exon scanning procedure based on pcr-ssp. rhag gene was investigated by exon-specific pcr amplification and sanger sequencing. results: no d, c, c, e and e antigens were detected in the proband's erythrocytes. the father and sister rh phenotype was: d+, c+, c+, e+, e+ whereas the mother rh phenotype was: d+, c+, c-, e-, e+. rh genotyping confirmed the rh phenotypes for all family members except for the proposita who genotyped rhd+, rhc+ and rhe+. all samples showed an homozygous status for the rhd gene and all rhd exons were detected by exon scanning. sequencing analysis revealed an homozygous c. c>t mutation in rhag exon in the proband whereas the rest of the family showed an heterozygous state in the same nucleotide position. the c. c>t mutation is responsible for the p.ser phe amino acid substitution predicted to be in the th rhag glycoprotein transmembrane segment. summary/conclusions: this study described the molecular background responsible for an rh-deficiency phenotype in an argentinean proband. we identified the novel missense mutation c. c>t in the rhag gene which results in the ser to phe single amino acid substitution that shows to be critical for rh antigen complex assembly within the erythrocyte membrane. further studies are being performed in order to determine whether the proband is rh null or rh mod . background: rh blood group system is the most immunogenetic blood group system and blood donor typing should account for all expressing antigens in order to prevent anti-d alloimmunization. aims: the objective of this prospective study was to investigate rhd alleles among blood donors who typed d-by serologic methods and positive for c and/or e. for this reason we developed an easy-to-perform dna-based screening method for the detection of rhd gene and positive samples were further characterized by two commercial pcr-ssp kits. methods: of individual blood donors within a month period, ( . %) typed as d-with standardized immunohematologic methods including the indirect antiglobulin test (iat). residual edta-anticoagulated blood samples were used to isolate genomic dna using the qiaamp dna blood kit (qiagen, germany) from out of ( . %) c/e+ and serologically d-donors. all dna samples were tested individually for the presence of rhd-specific dna sequences in the rhd promoter, intron , exon and exon by a multiplex pcr-ssp method. the reaction was conducted in a final volume of ll with primers that were applied as described by f. wagner et al. (bmc genetics, ) except antisense primer for exon and the two primers amplifying an hgh gene fragment as internal control, designed by our laboratory. pcr products were visualized by electrophoresis on a % agarose gel with ethidium bromide staining. in case of a positive reaction the sample was analyzed by pcr-ssp d weak and pcr-ssp cde (inno-train, germany). results: out of d-individuals analyzed, were ddccee, ddccee, ddccee and one had a ddccee phenotype. molecular analysis showed that ( . %) were negative for all four rhd dna regions. among the other samples, all of ddccee phenotype, three were found to be positive for rhd promoter, intron , exon and exon , three for rhd promoter and exon , and two for exon alone. further genotyping revealed five hybrid rhd-ce-d alleles [ rhd-ce( - )-d and rhd-ce( - )-d], one allele represented the del(m i) genotype, while the remaining two samples did not show an allele that could be determined with the pcr-ssp kits. summary/conclusions: serotyping is the standard method to assign transfusion strategies but it is not always capable to correctly define all samples that show weak reactions in d. a rhd genotyping strategy is needed to confirm d-blood donors and thus to avoid anti-d immunizations. for these reasons we suggest the implementation of an easy and possible cost-effective method. background: more than weak d types have been described to date. transfusion recipients with weak d type , , or are not at risk for forming allo anti-d when exposed to conventional rh d-positive rbcs. molecular analysis of weak d offers a more reliable basis than serotyping to determine the prevalence of weak d types and optimal d transfusion strategies. background: the d antigen, which consists of a mosaic of epitopes, is determined in all the blood donors and patients. most people are either rhd-positive or rhdnegative, but there is a certain number of people who have a variation of the d antigen, which are called weak d, partial d and del phenotypes. aims: the objective is to use molecular methods to determine whether blood donors in republika srpska (with whom a serological weak d antigen has been detected) really have the weak d antigen. in addition, determine whether blood donors, who have been determined as persons who are rhd-negative, with the phenotypes c and/ or e, who have the rhd gene and d antigen on the erythrocyte membrane, so weak that it could not be determined by serological techniques. methods: blood samples were used from regular blood donors, who have been determined as persons with a weaker d antigen, as rhd-negative or as c and/or e positive (based on the agglutination strength) using serological techniques, the test tube method, the microplate method and the gel method. gp.mur was also modelled and shown to closely resemble the tertiary structure of glycophorin a. the predicted structure is anti-parallel b sheets arranged in a "b barrel" also referred to as an ob-like-fold. the regions in which blood group antigens were identified in the predicted stable dimeric structure. summary/conclusions: ob-like-fold structures typically to bind oligonucleotides or oligosaccharides and are associated with cold shock proteins. further modelling is in progress to predict the structure of gpa/gpb heterodimers as a basis for understanding the presentation of blood group antigens. of interest, this finding is consistent with a previous report showing that this gpa binds to carbohydrates. this model serves as a foundation for future work regarding the properties of gpa, which includes identifying locations of specific interactions between gpa and other rbc surface proteins such as gpb and band , as well as identifying structural features of antigenic regions on gpa. . even though no significant differences were found among the groups studied, haplotypes containing the mcc b and sl polymorphisms were identified in d samples but were not found in tb and l groups. summary/conclusions: this preliminary data obtained suggests that cr polymorphisms and haplotypes, especially those containing mcc b and sl snps, could be involved in the disease pathogenesis of tuberculosis and leprosy. the entrance of mycobacteria into macrophages is mediated by complement receptors that facilitate their uptake by host cells so the combined haplotypes could be enhancing parasite phagocytosis and inflammation. further studies are being carried out to establish whether cr polymorphisms are risk or protective factors and whether other genetic variations in this receptor are also involved. abstract withdrawn. background: the dombrock blood group system consists of two antithetical antigens, do a and do b , and three high-prevalence antigens, gregory (gy a ), holley (hy), and joseph (jo a ). the rare do null or gy(a-) phenotype lacks all dombrock antigens, and the do null alleles vary with both do* and do* backgrounds. here we report the molecular basis of a novel do null allele in a gy(a-) brazilian patient with anti-gy a . aims: case presentation: an alloantibody to a high-prevalence antigen was detected in the serum of a year old woman from the northeast brazil with a history of pregnancies but no history of previous transfusion. she required transfusion because of a schedule for total thyroidectomy surgery due to a large compressive nodular goiter. the antibody did not react with the autologous rbcs but reacted by the indirect antiglobulin test in liss with all panel rbcs and other rbc samples tested except with the gy(a-) phenotype. the corresponding antigen was resistant to treatment with papain but sensitive to dtt and trypsin. these results suggested that the antibody recognized an antigen in the dombrock blood group system. the purpose of this study was to identify the antibody specificity and to determine the molecular basis of the phenotype detected. methods: the red cells phenotype and the presence of the dombrock related antibody in the serum were detected by standard hemagglutination techniques. rbcs and antibodies were from our in-house collection of rare samples. genomic dna was prepared from peripheral blood of the patient. dombrock genotyping was performed by id-core xt platform (grifols, spain). the exons of the do gene were amplified by pcr and directly sequenced. experimental immunohematology and diagnostic immunohematology diagnostic immunohematology experimental immunohematology, sanquin, amsterdam, netherlands background: typing of blood group antigens is essential to prevent transfusion reactions or haemolytic disease of the foetus and newborn. to date, the isbt recognises blood group antigens. most antigens ( ) belong to one of the blood group systems. since the genetic basis of these systems is known, genotyping of these antigens is possible. the molecular background of antigens is unknown and can only be determined serologically. one of these antigens is sd a (sid), first reported in .~ % of the population carry sd a on erythrocytes, but this frequency might be higher since identification is difficult due to variability in expression. in % of individuals sd a is present in urine. cells with a high expression of sd a (cad/sda++) are used for detection of antibodies. recently, a -cells antibody detection panel of bio-rad contained a sda++ cell and many individuals with anti-sd a were detected. the b galnt gene has been implicated in the synthesis of sd a . we collected individuals with and without anti-sd a to elucidate the genetic background of the antigen. aims: elucidation of the genetic basis responsible for loss of the sd a antigen on red blood cells. methods: routine diagnostics to identify antibodies in patients was performed using a bio-rad -cells panel, containing donor with high expression of sd a . additionally, pregnant women were screened for anti-sd a . dna of eight samples with anti-sd a and eight samples without anti-sd a was isolated for further analysis. sanger sequencing was performed on b galtnt exon - . results: sequencing of b galtnt revealed two homozygous mutations which are present in all eight individuals with anti-sd a , but not present in controls. the remaining two controls are heterozygous for these mutations. the first mutation within exon , c. t>c (enst . , rs ) changes a cysteine to arginine at position of the protein. the second mutation in exon c. a>g (rs ) does not change an amino acid. both snps have a maf of . and therefore we expect that . % of the population is homozygous for the minor allele. genotyping of a large population of pregnant women and the serological detection of anti-sd a in women with a homozygous mutation is in progress. summary/conclusions: the high frequency antigen sd a has not been linked to a blood group system because the molecular basis for loss of the antigen has not been elucidated. the b galtnt gene has been associated with sd a synthesis and therefore we analysed this gene for mutations in individuals with antibodies against sd a . a single homozygous mutation within exon causing an amino acid change was found in all individuals with anti-sd a , and no individuals without antibodies were homozygous for this snp. from population studies we expected~ % sd a -negatives, but either this frequency is an overestimation because of difficulties to detect low expressed antigens or mutations in other genes are interfering with sd a synthesis. a larger study of individuals with homozygous mutations in b galnt and linkage to sd a -negativity and presence of antibodies will be performed before sd a can be assigned to a new blood group system. abstract withdrawn. abstract withdrawn. background: erythrocyte duffy blood group antigen can scavenge chemokines in whole blood. duffy blood group gene consists of two major alleles: fy*a and fy*b. however, little is known regarding the association of duffy blood group polymorphisms with the red blood cell (rbc) chemokine scavenging. aims: the aim of this study was to determine the association of duffy blood group polymorphism with the rbc chemokine scavenging. methods: the duffy blood group were genotyped by ˊ-nuclease assay in healthy chinese han individuals, while erythrocyte chemokine scavenging function and duffy antigen expression from the same samples were measured using erythrocyte chemokine binding assays and quantitative flow cytometry respectively. results: rbc chemokine scavenging of cxcl was significantly lower in the individuals with the fy*a/fy*a genotype compared to those with fy*a/fy*b genotype (p = . ). similar result was also observed in rbc chemokine scavenging of ccl (p = . ). the expression of duffy antigen on rbc surface in the individuals with the fy*a/fy*a genotype was significantly higher compared to those with fy*a/ fy*b genotype (p = . ). summary/conclusions: duffy blood group polymorphism is associated with the differential rbc chemokine scavenging. it is probable that a change in duffy antigen structure caused by duffy blood group polymorphism is responsible for the differential rbc chemokine scavenging. background: individuals with p-phenotype can develop a naturally occurring anti-pp pk and has clinical significance, causing hemolytic transfusion reactions or hemolytic disease of the fetus and newborn. finding and procuring blood units of pphenotype is a challenge because of its rarity throughout the world. therefore, acute normovolemic hemodilution (anh) can be an on hand tool in the perioperative successful management of patient with rare blood group. however, this approach has not been commonly used aims: n/a. methods: n/a. results: a -year-old korean woman was referred to samsung medical center for surgical management for gallbladder malignancy. her blood type was group a, d-positive. the patient had no known history of transfusion. however, antibody screening and identification test using the column agglutination method (bio-rad, cressier, switzerland) showed panagglutination with negative reactions to autologous red blood cells, indicating the presence of alloantibodies to high frequency antigens. the specimen obtained from the patient was sent to the central laboratory of the swiss red cross (bern, switzerland) and confirmed as anti-pp pk. at first, the transfusion team of our hospital recommended the surgical team to postpone the surgery. however, anh was planned because postponing surgery was not preferred and the patient's preoperative hemoglobin was . g/dl. ml of blood was withdrawn through a radial arterial catheter in two ml blood bags containing citrate-phosphate-dextrose-a solution after anesthetic induction. equal volume of % hydroxyethyl starch solution was infused during the procedure. the patient underwent radical cholecystectomy and liver wedge resection with lymph node dissection, and two units of autologous blood were returned to the patient during surgery. she was then discharged h later with a hemoglobin level of . g/dl. later, the family study was performed with the standard serologic method using the proband's plasma containing anti-pp pk and sequencing of the a galt gene, which were conducted according to the protocols by koda et al.(transfusion. ) . the proband and her brother were homozygous for c. dupc, indicating a rare p phenotype. summary/conclusions: we experienced that autologous blood transfusions via anh is an alternative to allogenic rbc blood transfusion in patients who have no blood available because of high alloimmunization antibodies against rare blood groups. " and the third sample as "gypb*s_gyp*[ a], gypb*s_null(ivs + t)" with a predicted phenotype: s-s+ mi a + and s+s-mi a +, respectively. the gypa specific primers used for discrepancy resolution detected the nucleotide substitution, gyp.c. c>a, in gypa-b-a hybrid associated to gp.hut allele, thus confirming the id core xt result. the expression of mi a for one of these samples was confirmed using non-commercial anti-sera. hence, these three samples were not gp.mur but gp.hut phenotype. both alleles codify for the expression of mi a antigen since it is expressed on several hybrids between the usual forms of glycophorin a and b. two of these three gp.hut samples are african-american donors. gp.hut was reported in white people with a frequency about . % and in thais with . %. these three gp.hut cases found by id core xt in this study point to a higher frequency of this glycophorin variant and also to the presence in african american population. summary/conclusions: id core xt was able to detect two glycophorin phenotypes, gp.mur and gp.hut, which codify for the expression of mi a antigen. standard molecular methods should be implemented in pre-transfusion testing and obstetrical care routine to detect the most clinically relevant glycophorin variants in mns system. background: serf(+) is a high prevalence antigen in the cromer blood group system, which is encoded by a crom* allele. the lack of the serf antigen, serf(À) on red cells is caused by a single nucleotide polymorphism, c. c>t in exon of the decay-accelerating factor, daf gene. alloanti-serf has been found in thai pregnant woman with serf(À) and a serf(À) individual was found among thai blood donors. anti-serf is not a marketed product; hence, a molecular technique has to be implemented to genotype for the crom* allele among blood donors. aims: this study aimed to identify the crom* allele among thai blood donors leading to predicted serf(+) and serf(À) phenotypes. methods: dna samples obtained from , central thai blood donors were genotyped for serf allele detection using in-house pcr with sequence-specific primer (pcr-ssp) and confirmed by dna sequencing. results: the allele frequencies of crom* (+) and crom* (À) among , central thais were . ( , / , ) and . ( / , ), respectively. the homozygous of crom* (À/À) alleles was not found in this study. additionally, the pcr-ssp technique was validated by dna sequencing using randomly chosen samples together with heterozygous crom* (+/À) samples and the results were in agreement. summary/conclusions: our results confirm a high frequency of the crom* (+) allele in the thai population and their frequencies were similar to those formerly reported among thai blood donors. this study would be beneficial to predict the serf antigen from genotyping results due to unavailability of commercial antiserum. background: there is increasing interest in the use of molecular methods for predicting abo grouping. though nextgen and sanger sequencing have both been used to predict abo type, predicting abo type from buccal swab-derived dna and from deceased donors benefits from a quick and reliable method. besides a pcr-rflp that has been used by many labs for more than years, there is a commercially-available research use only (ruo) kit, and both interrogate nucleotides associated with o , o , a and b with a representing the ancestral allele. aims: the aim of this report is to compare two low-resolution polymerase chain reaction (pcr)-based methods, for investigation of samples submitted to a reference molecular immunohematology laboratory for abo typing discrepancies. fifty-six peripheral blood samples were tested, from patients and from blood donors. methods: genomic dna was isolated from peripheral blood mononuclear cells. background: del is the weakest known d positive phenotype in the rh blood group system and detectable only by adsorption and elution tests. the rhd g>a change is an important marker for del phenotype in east asians. a rapid and efficient pcr method for rhd gene g>a genotyping is useful in east asian countries. aims: the aim of this study was to develop a method for rhd g>a genotyping by using single-tube pcr with melting temperature(t m )-shift primers. methods: two allele-specific primer for rhd g>a and a common primer were designed and synthesized. two gc-rich tails of different lengths were attached to ends of the allele-specific pcr primers. single-tube pcr with t m -shift primers was carried out with the three primers. after pcr, melting curve analysis was performed. rhd g>a could be genotyped by differences of the t m s of the pcr products. all of genotyping results were compared with those obtained from conventional pcr-ssp. for the discordant results, rhd exon sequencing was performed to determine rhd g>a genotype. results: a total of samples were genotyped for rhd g>a by pcr with t mshift primers. samples were typed as a+/g-, samples were typed as a-/g+, samples were typed as a+/g+ and samples were typed as a-/g-. two samples typed as a+/g+ by pcr-ssp but a+/g-by pcr with t m -shift primers were confirmed as a+/g-by rhd exon sequencing. summary/conclusions: the single-tube pcr with t m -shift primers for rhd g>a genotyping is simple, rapid, accurate, and it is superior to conventional pcr-ssp. abstract withdrawn. background: the rh blood group system has numerous variant alleles, which may affect rh antigen expression, including rhd-rhce (d-ce) hybrid genes. these variant alleles are frequently found in people of african descent, and typically result in either d-negative (d-) phenotype, or partial d antigen expression, including silencing of high-frequency antigens and/or expression of low-frequency antigens. patients carrying those alleles are particularly at risk of alloimmunization, suggesting that their identification is important in diagnostics. quantitative multiplex polymerase chain reaction (pcr) of short fluorescent fragments (qmpsf) has proven successful for genotyping those dna samples carrying d-ce hybrid genes by assessing both qualitatively and quantitatively rhd and rhce gene exons. aims: the aim of this project was to genotype both rh genes in a cohort of brazilian patients with sickle cell disease (scd), which are known to be of african descent, by using the qmpsf approach and report hybrid gene variability in this population. methods: one-hundred fifteen dna samples were selected for the study and analyzed prospectively by the rhd-qmpsf and rhce-qmpsf approaches to investigate the copy number of all exons in both rh genes. genotypes were further confirmed or investigated by sanger sequencing and conventional pcr-rflp assays. results: in the dna samples, ( . %) exhibited a "wild-type" profile by qmpsf analysis. hybrid genes involving exon , which is functionally not relevant as reported before, was found in samples, including and samples carrying respectively rhd-ce( )-d and rhce-d( )-ce (two homozygous each). except two samples that require additional studies ( . %), rhd zygosity was resolved successfully: (n = rhd gene copies; . %), ( ; . %) and ( ; . %). clinically relevant, i.e. partial d, genotypes were identified in four hemizygous samples ( / , . %) carrying rhd*dau , rhd*dv. , a rhd*diiia-like allele, and a novel rhd*d-ce( :g h-y s-n i)-d allele, as confirmed by sequencing. other hybrid alleles, such as rhd* n. and rhd*diiic, were also found in trans with a normal rhd* allele. in rhce, c/c genotype could be resolved. the rhce*ce (rhce*ce ( c)-d( )-ce) allele, which is commonly cis-associated with rhd*Ψ, was observed in four samples. however the clinically relevant polymorphisms in variant rhce alleles, such as those involved in cemo, cear, ceag, and ceti, were mostly identified by other standard methods. summary/conclusions: although most of the brazilian patients with scd investigated in this study did not carry rhd-rhce hybrid genes, qmpsf analysis has been shown to be an efficient tool in the whole genotyping process to investigate rh gene variation. as previously reported, it has been conclusive for characterization of rhd zygosity and identification of rare, as well as novel, variant alleles. additionally, our results show a large diversity of hybrid genes among the brazilian patients with scd. therefore, we suggest that qmpsf may be used as a complementary screening approach for assessing rh genotype in selected patients and donors. = ) vs. non-bleeding (n = ) patients. platelet, pmp and cp phenotype and function were evaluated by flow cytometry: activation and granule release were examined by antibodies against granulphysin (cd ), p-selectin (cd p), activated gpiib/iiia (pac- ) and phosphatidylserine (ps) (lactadherin) unstimulated and adp, trap or collagen stimulated. coated platelets were identified as a highly granulated independent cell population appearing following collagen stimulation, gated on side scatter and gpiba (cd b). normal healthy reference levels were available. results: the platelet count in bleeding ( /l) and non-bleeding ( /l) patients was comparable (p = , ). bleeding patients had a higher bat score compared to non-bleeding patients ( vs. , p < , ). the proportion of cps was normal in all patients. however, in non-bleeding patients the proportion of ps+cps and per cell ps expression (mfi) ( , % and , mfi) were higher, compared to bleeding patients ( , % and , mfi, both p < , ), and the proportion of ps+cps correlated negatively with bat score (r = , , p < , ). cd + cp was higher in non-bleeding ( , % and , mfi) compared to both bleeding patients ( , % and , mfi) and significantly higher than the reference level ( , % and , mfi, both p < , ). finally, the proportion of ps+pmps was normal in bleeding patients, but their pmps expressed higher than reference ps per cell, both unstimulated and for all agonist ( , mfi unstimulated vs , mfi reference, p < , ). summary/conclusions: patients with it exhibited different bleeding tendency despite comparable thrombocytopenia. in non-bleeding patients the proportion and per cell level of ps+ were higher, indicating that generation of cps with high ps expression is a critical factor determining bleeding phenotype. the finding of high pmp ps per cell level in bleeding patients could represent an inadequate compensation for lack of cp function, indicating that procoagulant pmps may be less important than cps for thrombocytopenic bleeding. quantification and characterization of cps may be a useful tool for future assessment of bleeding risk as well as a therapeutic target in it and other conditions with bleeding diathesis and/or thrombocytopenia. more studies investigating this field are warranted. background: alloantibodies against human platelet antigens (hpas) and human leukocyte antigen (hla) are implicated in several immune-mediated platelet disorders. detection of these antibodies is crucial in the diagnosis and management of these disorders. aims: to establish a method detecting hpa- , hpa- , hpa- , hpa- and hla antibodies using luminex bead technology. methods: monoclonal antibodies specific for platelet glycoproteins and hla class i molecules were separately coupled to the luminex microbeads. positive anti-hpa- a, anti-hpa- b, anti-hpa- a, anti-hpa- a samples were used to validate the specificities of the luminex assay. the anti-hpa- a, anti-hpa- a standard samples were used to evaluate the sensitivities of the luminex assay by serial dilutions (from neat to / ). results: samples collected from patients or isbt platelet workshop were tested by the luminex assay. the results showed that luminex assay could detect antibodies against hpa- a, hpa- b, hpa- a, or hpa- a successfully from the known samples. the sensitivities of the luminex assay detecting anti-hpa- a, and anti-hpa- a were : and : , respectively, using the standard samples. no cross-reactivity was observed in the samples containing multi-platelet antibodies, or mixture antibodies against hpa and hla. the results of samples with platelet disorders were agreement with those of monoclonal antibody immobilization of platelet antigens (maipa) assay. summary/conclusions: luminex beads coupled with monoclonal antibodies could be successfully used to detect hpa and hla antibodies with high sensitivity. background: platelet transfusion is important in clinical treatment. the expression of abo antigen on platelet surface is differential, so it is usually need to ensure the consistency of the abo antigen in clinical transfusion. but in many cases, it is difficult to find the platelets that the abo blood type matched between the recipient and donor, and abo-incompatible platelet infusion is required in these cases. to data, the expression of abo antigens on platelets in normal blood group individuals is rarely reported in chinese population. aims: to understand the differential expression of abo antigen on platelet surface in population of zhejiang province, china. methods: total of individuals with normal abo groups ( group a, group b and group ab individuals, and group o as negative control of abo antigens on platelets) were analyzed. the expression of abo antigens on platelets was determined by flow cytometry using monoclonal antibodies: fluorescein isothiocyanate (fitc)-conjugated mouse antihuman blood group a and pe-conjugated murine igg anti-b antibody ( pe bgrl ). flow cytometric parameters were statistically analyzed by the mann-whitney test or the kruskal-wallis test to observe the difference in two or more groups using graphpad software v . . the correlation and regression analysis between a and b antigen in the platelets and rbcs were also performed by the software. population studies were reported as the mean and standard deviation (sd), and p values less than . were considered statistically significant. results: according to mfi values of abo antigens expression on platelets, the samples were divided into three groups: low expression (le), high expression(he) and moderate expression (me) according to the background mfi observed in group o samples. it was found that about . % of the individuals had a weak expression of abo antigen on the platelet surface in zhejiang province. there was a significant difference in the intensity of antigen expression between these three different groups of the same blood group. for each blood group, there was a positive correlation between the intensity of abo antigen expressed on the platelet membrane and red blood cells of the individuals. results: cases were found with antibody positive. among them, cases ( %) were only anti-hla-i positive, cases ( %) were only anti-hpa positive, cases ( %) were both anti-hla-i and anti-hpa positive. cases were found without anti-hla-i or anti-hpa. among the cases with anti-hpa positive, the distributions of anti-gpiib/iiia, anti-gpia/iia, anti-gpib/ix, anti-gpiv were . %, . %, %, . %, respectively., hla antibody positive rate in the female patients was higher than that in the male and hpa antibody positive rate in the female was lower than that in male, but there was no significance difference between them (p > . ). summary/conclusions: in ptr patients, the platelet antibody was mainly hla-i antibody combined with hpa antibody. background: human neutrophil antigens (hna) are polymorphic structures located on surface membrane of human neutrophils. alloantibodies against hna are implicated in a number of clinical conditions, including immune-mediated neutropenia and transfusion reactions. genotyping for human neutrophil antigen (hna) systems is an important in the diagnosis of disorders involving alloimmunization to hna. aims: the aim of this study was to investigate the hna allele frequencies among blood donors and hematological patients undergoing blood transfusions and to estimate possible hna incompatibilities and risk of hna alloimmunization. methods: a total of blood donors and hematological patients from the north-west region of the russian federation were recruited. dna samples were obtained and typed for hna- , - , - and - systems using polymerase chain reactions with sequence-specific primers (pcr-ssp). specific primers for hna were designed and the polymerase chain reaction amplification conditions were optimized. the v test was used to test for the hardy-weinberg equilibrium for the hna systems. the probabilities of the incompatibility and the potential risk for alloimmunization against different hna systems after random transfusions were estimated based on the hna allele and genotype frequencies. results: in blood donors, the frequencies for the fcgr b* (hna- a), fcgr b* (hna- bd), and fcgr b* (hna- bc) alleles were . , . and . ; for the slc a * (hna- a) and slc a * (hna- b) alleles, . and . ; for the itgam* (hna- a) and itgam* (hna- b) alleles, . and . ; for the itgal* (hna- a) and itgal* (hna- b) alleles, . and . , respectively. in hematological patients, the gene frequencies for hna- a/ bd/bc, - a/ b, - a/ b, and - a/ b were . / . / . , . / . , . / . , and . / . , respectively. no statistic significant difference between genotypes in these groups was observed. since the allele frequencies of hna - , - - for hematological patients and donors did not have statistically significant differences, possible hna incompatibilities and risk of hna alloimmunization were estimated based on the obtained data on the allele and genotype frequencies of hna in a group that combines donors and hematological patients (n = ). the predicted risk of hna- , - , - , - incompatibilities in this cohort were . %, . %, %, and . %, respectively. the possible risk of hna- a, - bd, and - bc alloimmunization were . , . , and . , respectively; of hna- a and - b alloimmunization, . and . ; of hna- a and - b alloimmunization, . and . ; of hna- a and - b alloimmunization, . and . , respectively. summary/conclusions: the information about hna gene frequencies can be used not only in blood services for detection and identification of hna alloantibodies in donors and assessment of alloimmunization risk but also for anthropological studies. background: non-invasive fetal rhd genotyping is performed using circulating cell-free fetal dna from maternal plasma sample and real-time polymerase chain reaction. this antenatal routine dna test is used to target rh-ig administration to prevent hemolytic disease of the newborn. aims: the aim of this study is to characterize maternal rhd variants responsible for indeterminate results during fetal rhd genotyping due to early amplification of at least one of the exons ( , or ) of the rhd gene. methods: samples were tested from / / to / / using free dna fetal kit â rhd. samples ( , %) yielded a premature signal for one or more exons of the rhd gene. after extraction of maternal cellular dna, the maternal rhd was characterized using rhd beadchip assay (immucor/bioarray). rhdiiia-ce( - )-d summary/conclusions: greater diversity is observed in the caucasian population rather than in the afro-caribbean. % of the identified variants are rhd negative alleles including alleles leading to partial rh antigen expression. unexpected alleles are found such as weak d type , , or . these data underline the benefits of maternal rhd genotyping when abnormal early signals are detected during noninvasive fetal rhd genotyping. background: a considerable number of rhd alleles responsible for weak d phenotypes have been identified. serologic determination of these phenotypes is often doubtful and makes genetic analysis of rhd gene highly desirable in transfusion recipients and pregnant women. dna-based methods are useful for enhancing immunohematology typing in doubtful d phenotypes at pregnant women. aims: determination of the rhd gene in a cohort of pregnant women with doubtful d phenotypes. methods: determination of the rhd phenotyping was performed with microagglutination technique biorad and ortho diagnostic simultaneously. rhd genotyping was performed on cases with d typing serological discrepancies with ready-to-use inno-train rbc-ready gene cde and rbc-ready gene d weak test kits based on polymerase chain reaction with sequence-specific priming (pcr-ssp) to unclear serologic findings. results: molecular analyses showed of ( %) pregnant women were rhd*weak d type and not at risk for anti-d. rhd*weak d type were typed in cases ( %) and case was rhd*weak partial . and potentially at risk for being alloimmunized producing anti-d allo-antibodies. summary/conclusions: appropriate classification of rhd phenotypes is recommended for correct indication of rhig in pregnant women. however, the serologic differences between rhd-negative and rhd-positive pregnant women is a real problem for unnecessary application of rhig prophylaxis in pregnant women with d variants. conclusion: antenatal rhig prophylaxis is useful in rhd negative pregnant women. with genotyping we found that % of serological doubtful rhd negative women was d variants that not produce anti d antibodies. in that cases those rhig prophylaxis was unnecessary and harmful as a product of human origin. on other hand there is a save up of a stock of rhig which is any way in deficit. is it time to think about cost benefit of rhig prophylaxis and genotyping in pregnant women. background: in may , uk neqas (btlp) created an external quality assessment (eqa) sample designed to mimic a feto-maternal haemorrhage (fmh) bleed of ml. all material used passed pre-acceptance serological testing; samples were dispatched to participants in countries. post-dispatch testing by flow cytometry (fc) using an anti-d marker showed a bleed volume of . ml so an investigation was initiated. aims: to determine the cause of the unexpectedly low bleed volume and what lessons could be learnt. methods: production methodology and results of pre-acceptance testing were reviewed. fc testing was repeated, plots examined, and the fmh scientific advisory group consulted for advice. further fc testing was performed at wbs using alternative markers, and the material used was investigated at ibgrl. participant results were examined to determine if the sample should be withdrawn from scoring. a questionnaire on how results were managed was sent to the participants using fc with an anti-d marker. results: a material production methodology review showed no obvious cause of the erroneous in-house result. review of pre-acceptance testing images showed no issues, further d-typing of the cord showed + reactions vs. two reagents by tube, cf. + with two different reagents by column agglutination technology. repeat fc testing using the anti-d marker gave similar results; however, closer examination of the plots showed a left shift in the positive peak, indicating reduced fluorochrome binding, possibly due to reduced d antigen density on the cord cells. further fc testing at wbs demonstrated a marked reduction in fluorescence intensity with an anti-d marker. further investigation using an anti-hbf marker showed a bleed volume of . ml, indicating the correct proportion of cord material had been used during sample production. additional serology at ibgrl on the cord material showed reactions which were weaker than the control with / anti-d reagents. overall, the investigation supported the hypothesis that the cord material was d variant. a review of results submitted by participants mirrored the fc investigation and the sample was withdrawn from scoring, as the fc median result is used to calculate scores and the d variant cord was clearly affecting testing with an anti-d marker. the questionnaire showed that all respondents examine fc plots and the gating used, but not all act on them before reporting results, and not all have a back-up plan for anti-d ig dosing in a similar situation. later sequencing of the d gene revealed the cord donor to be dvii which can have a lower than normal d antigen density. summary/conclusions: the use of a d variant cord in an eqa sample was not planned, but allowed uk neqas to highlight some important learning points: -thorough examination of fc plots is essential to avoid underestimation of fmh; a controlled procedure should be in place if modification of gates is required -access to cord/neonatal blood to allow serological investigation may be useful in a similar clinical situation -it is important to have a back-up plan for issuing anti-d ig in the event of an uninterpretable fmh result background: allo-antibodies against fetal blood group and platelet antigens produced by antigen-negative pregnant women can cause hemolytic disease of fetus and newborn (hdfn) and fetal and neonatal alloimmune thrombocytopenia (fnait). prediction of the fetus antigen status in immunized women is important for making decisions concerning further management of pregnancy. nipt is widely used for determination of fetal blood groups but determination of proper specificity in the real-time amplification of a single nucleotide polymorphism (snp), such as k or hpa- a, requires modified protocols. droplet digital pcr (ddpcr) permits detection of low-grade fetal chimerism in maternal plasma dna with higher specificity using allelic discrimination pcr protocols. aims: to establish ddpcr protocols for non-invasive prenatal diagnostics (nipd) of clinically important blood group antigens. methods: dna was isolated from plasma samples of pregnant women and donors with known genotypes (easymag, biomerieux). allelic discrimination protocols for determination of k/k (n = ), s/s (n = ), hpa- a (n = ), hpa- (n = ), hpa- (n = ), hpa- (n = ) genotypes were performed using ddpcr method with droplet digital tm (biorad). the results of allelic discrimination performed using ddpcr were concordant with the already known phenotype/genotype of donors and pregnant women. ddpcr enabled the detection of - , reads for total dna from plasma in tested samples. all fetal results were in agreement with antigen positive genotype of the neonates and the fetal chimerism was from , % to , % (one case was for advanced pregnancy - week of gestation). in / tested samples false positive results were detected at the level of or unspecific reads. summary/conclusions: the implementation of allelic discrimination protocols for ddpcr allowed detection of fetal-maternal incompatibility in k/k, s/s and hpa- a, - a/b, - a/b, - a/b antigens encoded by snp. background: in france, for pregnancies complicated by anti-d (rh ) and anti-c (rh ) allo-immunization, the tests currently used to quantitate maternal antibodies are tube method titration and continuous flow analysis determination of the antibodies concentration. recently, an automated assay was developed using the column agglutination technology on the ih- system (bio-rad â). aims: we wanted to evaluate the score, calculated from the agglutination profile of the antibodies on the ih- system, as a quantitative data to appreciate the level of maternal antibodies. methods: titers from samples containing anti-d and containing anti-c have been established using the semi-automated tube method performed since decades in our lab and the fully automated gel method on the ih- system. scores were calculated manually in both cases. antibodies concentrations were also determined for all samples by continuous flow analysis on our auto-analyzer device (evolution iii ams alliance). we looked for a possible correlation between anti-d and anti-c scores and the corresponding concentrations using the spearman correlation test. results: anti-d tube and gel scores were significantly correlated with the anti-d concentration values (p < . , r = . and p < . , r = . respectively). anti-c scores were also significantly correlated with anti-c concentration values (p < . ) but gel scores have a better correlation coefficient than tube scores (r = . versus . ). it was easier to extrapolate gel score thresholds than tube score thresholds from the autoanalyzer values, with the aim of triggering fetal monitoring by ultrasounds and measurements of the peak systolic velocity in the middle cerebral artery only for risk pregnancies. the determined gel score thresholds were and , corresponding respectively to ui/ml ( uchp/ml) of anti-d and . ui/ml ( uchp/ml) of anti-c. conclusions: calculating the score from the hemagglutination profile displayed by the ih- system provides added values compared to the sole reading of the titer. for anti-c immunization, gel scores are more discriminant than tube ones and better correlated to the concentration values established by continuous flow analysis. the proposed score thresholds to trigger fetal antenatal monitoring need, however, to be confirmed on more samples and to be clinically documented. background: hdnf is due to maternal igg alloantibodies directed against fetal antigens that cross the placenta during pregnancy, causing hemolysis in the fetus, anemia that can lead to edema, ascites, hydrops and, in some cases, death. the diagnosis and management of hdnf is based on maternal screening, and middle cerebral artery (mca) doppler monitoring. in severe hdnf intrauterine blood transfusions (iuts) and or exchange transfusion (et) after birth are necessary to correct anemia, to prevent and treat fetal hydrops. aims: we report eight years of experience in our immunohematology reference laboratory (irl) to highlight the importance of red cell antibody detection as a fundamental parameter to identify pregnancies with high fetal risk and to drive a correct treatment. methods: we report laboratory data from pregnant women with a positive indirect antiglobulin test (iat) referred to our irl from january to december . we performed antibody screening and identification by indirect antiglobulin test (iat) in microcolumn method with biovue system (ortho-clinical diagnostics, raritan, usa), and the title of antibodies in iat by tube method without additive. follow-up tests were also performed in the presence of significant red cell antibodies in order to check antibody title and begin clinical monitoring. threshold values were ≥ : for anti kell antibodies and ≥ : for other specificities. results: out of women, ( . %) displayed clinically significant antibodies, ( . %) clinically insignificant antibodies and ( %) natural antibodies of different specificities. among women with clinically significant antibodies the most frequent was anti-d ( . %) also in combination with other rh antibodies ( . %), while anti-k accounted for %, anti-e for % and antibodies against high-incidence antigens for . %. anti-m and anti-le a antibodies were also found ( . % and % respectively) but they were not clinically significant. among women with clinically relevant antibodies, showed a critic antibody title and they underwent gynecological and obstetric monitoring. fetuses resulted affected by hdfn, displaying anti-d in cases and anti-kell in . fetuses with severe hdfn (anti-d in and anti-kell in ) required iuts, were treated with et, received red blood cells units at birth. summary/conclusions: the mother screening program led to important improvements in the outcomes of hdfn. the identification of women with clinically significant antibodies allowed an appropriate monitoring program and therapy. background: the hemolytic disease of the fetus and newborn (hdfn) is a severe disease, resulting from maternal erythrocyte alloantibodies directed against fetal erythrocytes. alloimmunization in pregnant women has been found to range from , % to , % worldwide. there are over erythrocyte surface antigens, of which more than have been reported to be associated with hdfn. although anti-rhesus d was once the major etiology of hdfn, the universal introduction of antenatal and postpartum rh immunoglobulin has resulted in a marked decrease in the prevalence of alloimmunization to the rhd antigen in pregnancy. consequently, alloantibodies other than anti-d emerged as an important cause of severe hdnf, in particular anti-k and anti-c. however, there are other antigens that have also been found to be associated with hdfn. aims: retrospective identification of erythrocyte antibodies in pregnant women in hospital de braga in and . methods: this study was planned to assess the prevalence of erythrocyte antibodies responsible for alloimmunization, excluding abo-immunizations, in pregnant women attending the antenatal clinics of hospital braga during years, from january to december . in this study, we retrospectively evaluated the erythrocyte antibody screening results of pregnant women. women with positive erythrocyte antibody screening also underwent identification with gel card system following the manufacturer's instructions (diamed â ). the outcomes of infants, whose mother's indirect antiglobulin tests were found to be positive, were examined. direct antiglobulin tests, jaundice and phototherapy history, transfusion and mortality of the newborns were recorded. results: during the study period, pregnant women were attended in hospital de braga. the laboratory registered positive erythrocyte antibody screening tests. the prevalence of positive erythrocyte antibody screening was , %. anti-d was the most common antibody found ( , %). anti-d prophylaxis given during pregnancy was responsible for of cases and maternal antibody titer levels did not exceed among these cases. the prevalence of non-rhd immunization was %. anti-e ( , %) was the most frequent alloantibody other than anti-d followed by anti-m ( , %) and anti-c ( , %). multiple maternal antibodies were found in pregnant women. four women had types of alloantibodies: anti-c and anti-e; anti-c and anti-d; anti-k and anti-cw; anti-e and a non-identified antibody. one pregnant had types of alloantibodies: anti-d, anti-c and anti-e. of all cases of newborns whose mothers had a positive antibody screen tests, icterus occurred in % of them and phototherapy was given in %. summary/conclusions: the prevalence of positive erythrocyte antibody screening in hospital de braga was , %. the erythrocyte antibody screening showed that anti-d was the most common antibody found ( , %) in most of the cases because of anti-d prophylaxis. the prevalence of non-rhd immunization was %. the other most frequent alloantibodies were anti-e ( , %), anti-m ( , %) and anti-c ( , %). an increasing prevalence of non-anti-d alloimmunization was found and there are currently no preventive strategies. in contrast to rhd alloimmunization, the main risk factor for non-anti-d alloimmunization is a previous transfusion therapy. thus, it is important to minimize the exposure of women to incompatible erythrocyte antigens through unnecessary transfusions when possible. background: the mns blood group system is one of the most complex blood group systems. although alloanti-m is a common antibody observed in pregnant women and could also be found in the serum of individuals who have not been exposed to m positive erythrocytes, it is rarely clinically significant and has been regarded as an unimportant antibody to cause hemolytic disease of the fetus and newborn (hdfn), especially in caucasian and black ethnic groups, for a long time. however, an increasing number of cases of severe hdfn resulting in fetal hydrops and recurrent abortion caused by alloanti-m have been reported mainly in the asian population, especially in the japanese and chinese populations. aims: to summarize the characters of serological testing in preterm twins newborns suffered with severe hdfn. methods: the blood sample of two newborns with severe hdfn and the mother, who had the history with three hydrops fetus, were collected. abo, rhd, rhce, and mn blood group typing of the twins newborn and their mother were performed in saline with tube or gel card. direct agglutination test (dat), elution test, antibody specificity identification and antibody titer detection were conducted by iat method in gel card. results: o, rhd(+), and ccee blood groups were identified both in the mother and the twins newborn. background: in france, since may , the legislation does not promote anymore the use of the reference tube method for titration of anti-red blood cells antibodies. this opened the way to the use of newly developed automated anti-red blood cells antibodies quantitation by column agglutination technology. aims: we wanted to assess the performance of titration and scoring by the id-gel test on the ih- system (bio-radâ) and to compare it with the performance established for the reference tube method, used in our lab since decades. another objective of the study was to determine titer thresholds for the gel method, to trigger fetal monitoring by ultrasounds and measurements of the peak systolic velocity in the middle cerebral artery. methods: an home-made internal quality control (iqc) prepared and calibrated using the international anti-d standard ( / ) was used to determine the intraassay and interassay imprecisions, regarding the score and the titer results. patients samples for testing were chosen during the -months assay period, regarding the specificity of the antibodies and the tube titer in order to cover a wide range of have lower values. the highest differences (more than to dilutions higher) were seen for antibodies directed against rh system antigens. among the other specificities, anti-k (kel ) and anti-m (mns ) antibodies show the most samples with equal or lower titers compared to the tube method. conclusions: automated anti-red blood cell antibodies titration by column agglutination technology on ih- system shows better intra and interassay cvs compared to the tube method. it is explained by the fully automated process that includes the reading step. titer results are almost always higher with the gel technology. thus, it seems possible to safely extrapolate the titer thresholds defined for anti-red blood cells antibodies by the tube method to the gel method. however, based on future clinical studies and fetal/neonatal outcomes, it would probably be necessary to increase these thresholds, at least for anti-rh antibodies, in order to avoid heavy, expensive, stressful and useless monitoring of some pregnancies. results: the first case was a -day-old female infant, yellowish skin developed the next day after birth. her capillary bilirubin level was mg/dl, the evidence favored neonatal hyperbilirubinemia and the clinical manifestation revealed hemolysis symptoms. her laboratory findings showed elevated reticulocytes ( . %), ldh ( iu/l) and g pd ( . u/ghb); dat (+/-), iat (-), anemia (hb . g/dl, hct %), and blood smear showed anisocytosis, spherocytes, and polychromatic rbc. her mother blood typed o, d positive, while her blood type was b, d positive and anti-b was found from her elution rbcs ( + ). due to rarely severe anemia with abo incompatibility, maternal plasma was analysed for abo igg antibodies and showed high antibody a and b titre with : and : . the female infant received one unit washed-prbcs for anemia and intensive phototherapy for hyperbilirubinemia. her clinical condition improved significantly, hb rose to . , bilirubin level was within normal range, she was discharged. another -days-old male infant was our second case. on the third day after birth, yellowish skin discoloration developed and bilirubin level was mg/dl. two days later, his transcutaneous bilirubin (tcb) measurement data was high and laboratory findings also showed raised reticulocytes ( . %), dat (+/À), iat (À), hb . background: anti-indian b is a rare alloantibody against the high frequency antigen in b . individuals with the in: ,- phenotype (in(a+b-)) are observed with a frequency of < . % in the indian population and have not been described in caucasians. the majority of anti-in b antibodies have been reported in individuals without previous transfusions, indicating the possibility of a naturally occurring antibody. anti-in b is considered clinically significant and haemolytic reactions after in b -incompatible transfusions have been reported. haemolytic disease of the foetus and newborn (hdfn) due to anti-in b has not been described. however, a positive direct antihuman globulin test (dat) may be observed. aims: to describe the challenges of managing a pregnancy and childbirth of a woman with an anti-in b . methods: serological investigations were performed by iat (tube and column agglutination). papain and trypsin treated cells were also utilised. soluble recombinant in blood group proteins (in-rbgp) (inno-train, germany) were used in neutralization tests. the clinical significance of the anti-in b antibody was determined by monocyte monolayer assay (mma). genomic dna was isolated from whole blood and the samples were further characterized by pcr amplification and sanger sequencing of exon of cd . results: in a -year-old pregnant (para ) woman of indian origin without previous transfusions, an alloantibody of the specificity anti-in b with a titer of : was detected by iat (negative with papain-treated cells) at gestational week (gw) and . the mma, performed in duplicate on samples taken at these dates, showed a mi of . %/ . % and . %/ . % respectively. the mi was interpreted as follows: - % not relevant; - % inconclusive; > % clinical significant. the patient's parents were typed heterozygous, in: , whereas her husband was homozygous, in:- , . due to the husbands phenotype, the fetus was predicted to be in b positive. doppler flow measurement of the peak systolic velocity in the middle cerebral artery of the foetus was normal. delivery took place at gw without increased bleeding. the neonate presented no clinical manifestation of hdfn. neither the mother nor the baby required blood transfusions. summary/conclusions: we report the case of a pregnant woman of indian origin with an anti-in b alloantibody. the first mma, performed in gw , was inconclusive whereas the second mma, performed in gw , indicated that the antibody was clinically significant. if the mi-increase is only due to the pregnancy or has also a clinical significance, cannot be stated. in b negative blood components were not available and the patient's relatives were all in b positive. therefore, measures to avoid transfusions, including optimised peripartal management of haemostasis, was of utmost importance. with only few cases published, the risk of hdfn could not be excluded with certainty. an intrauterine investigation by doppler was performed to exclude relevant anaemia of the fetus. no transfusion was needed at delivery as there were no haemorrhagic complications. the neonate presented no clinical signs of hdfn. background: hemolytic disease of the fetus and newborn (hdfn) is a disease which if untreatedcan cause perinatal mortality and morbidity with a substantial risk for long-term sequela. in albania we lack of studies in this field. aims: the aim of this study is to determine the predictive value and the reliability of the "critical titre" during the evaluation of red cells alloantibodies ability to cause the hemolytic disease of fetus and newborn. methods: we conducted a descriptive, cross-sectional study. the data were collected in the university hospital for obstetrics and gynecology in albania. in the study were included immunized pregnant woman for anti-d antibodies and their newborns which were affected from the hemolytic disease of fetus and newborn. the data belong to the period and . results: the "critical titre" in our study was , meaning that this was the minimal value of the titre antibodies that could cause hemolytic disease of fetus and newborn. our study concluded that only newborns were born without the hemolytic disease of fetus and newborn and the titre values were less than . moderate hemolytic disease of fetus and newborn were caused between the titre values - . the summary/conclusions: the titre values of the mothers are a predictive option of the high risk of giving birth to a child with the hemolytic disease of fetus and newborn. it is recommended that in this cases the mother should be followed with doppler ultrasonography to measure the blood flow of the middle cerebral artery. also the doctors should recommend in pregnant women with positive coombs test not only the identification of the anti-d antibodies but also the identification of the other antibodies such as anti-e, anti-c, anti-k. background: rhd-negative pregnant women with allo-anti-d are at risk of having a fetus affected by haemolytic disease of the fetus and newborn (hdfn) where the fetus is rhd-positive. the rhd allele is highly polymorphic and many rhd variants give rise to an array of partial d phenotypes. the clinical significance for many partial d phenotypes is not well-established. rhd genotyping by non-invasive prenatal testing (nipt) to assess the fetal rhd status determines whether the fetus is at risk for hdfn. nipt tests also include strategies for detecting maternal rhd variants to provide for accurate reporting. however, the presence of a paternal rhd variant, while having the potential to confound nipt interpretation, is often not recognised. we report a "trio" family study triggered by a request for nipt for an rhd-negative pregnant mother, weeks gestation, who presented with allo-anti-d and anti-jk a antibody. subsequent paternal and fetal rhd genotyping was conducted and revealed a novel variant rhd allele. aims: we aim to characterise the paternal rhd allele and review clinical case features. methods: rh phenotyping was performed by standard serological procedures. nipt tested for fetal rhd exons , and . rhd genotyping on whole blood/cord blood dna was performed on the immucor bioarray rhd beadchip kit which predicts a rhd phenotypic variant of best fit. dna sequencing was performed using the illumina trusight one sequencing panel. copy number variation (cnv) analysis was used to assess the rhd exon structure and zygosity. results: the paternal red cells typed as group o rhd+c-c+e-e+, (ror). nipt genotyping detected fetal rhd signals for all exons, predicting rhd-positive. no maternal rhd sequences were detected consistent with homozygosity for the rhd deleted haplotype. for both paternal and cord genomic dna (gdna), beadchip genotyping predicted a rhd variant "diiia/cehar". furthermore, signal drop out was observed at nucleotide positions (c. , c. , c. ) located in rhd exon suggesting exon was either deleted or rhce-replaced. paternal and cord gdna sequencing detected out of snps (c. g>t, c. c>t, c. a>c, c. c>g) associated with diiia phenotype plus additional snps (c. g>a, c. g>c) on the rhd gene. both were rhd hemizygote by cnv analysis. no rhce variants were detected. clinical case features: the maternal anti-d quantitation increased from . iu/ml ( weeks gestation) to iu/ml ( weeks gestation). the fetus required intrauterine transfusions during the pregnancy to manage the hdfn. summary/conclusions: both father and fetus carry an rhd allele that does not align with alleles encoding diii phenotypes. this putative novel rhd variant allele comprises snps associated with diiia and with a possible exon deletion/rhcereplaced. a similar allele was reported in literature, although based on sequence analysis only, with no phenotype data. the variant allele here encodes rhd-positive phenotype and we predict that there may be a loss of d-epitopes. notwithstanding, the clinical presentation shows that maternal anti-d against this rhd phenotype (presumed partial) is associated with a severe hdfn and that such rhd blood group phenotypes are of clinical significance for alloimmunised pregnancies. abstract withdrawn. background: cd is a glycosylphosphatidylinositol (gpi)-anchored protein with apparent molecular mass of kda. in addition to being expressed on human plts, cd is expressed on activated t-cells, endothelial cells, cd + hematopoietic stem cells as well as on progenitor cells. in the chinese population, the calculated allele frequencies of hpa- a and - b are . and . , respectively. based on these data, the risk of alloimmunization against hpa- alloantibodies due to incompatible plt transfusion or pregnancy is expected to occur in relatively high frequency. however, until today there is no report of hpa- alloimmunization in the chinese population. in this study, we analyzed sera from hydrop fetus cases by maipa technique and icfa. aims: to detect the anti-hpa b alloantibodies by maipa and icfa. methods: a -year-old mother, gravida /para . the mother in the first pregnancy was diagnosed hydrop fetus at pregnancy weeks by ultrasound. in the second pregnancy, fetal hydrops was observed by ultrasound at pregnancy weeks. the mother's irregular antibody test was negative. the maternal platelet specific antibodies and hla antibodies were negative. blood routine and morphological examination of fetal umbilical cord blood showed that plt count dropped to . /l, wbc count dropped to . /l, including neutrophil %, lymphocyte %, mononuclear %, eosinophil %, basophil %, red blood cells were normal, hb was g/l. screening for hla and plt-specific antibodies was performed using a elisa-based plt antibody kit (pakplus, gti diagnostics) as recommended by the manufacturer. plt antibodies were detected by icfa and maipa.hpa genotyping was detected by cpr-ssp. results: the fetus's genotype was hpa- a/a, - a/a, - a/a, - a/a. - a/a, a/a, a/a, a/b, naka (+) and the maternal was hpa- a/a, - a/b, - a/a, - a/a. - a/a, a/a, a/ a, a/a, naka (+). the paternal genotype was hpa- a/a, a/b, a/a, a/a, a/a, a/a, a/a, a/b, naka (+), which was the only incompatible antigen compared with the maternal hpa. samples were tested using the fresh plt panels consisting of hpa- aa and - bb homozygous donors. the reactivity of the negative control and the mother's sera with the plts from hpa- a/a (donors ), hpa- a/b (donors ) and hpa- b/b (donors ) donors by maipa. the mother's serum showed no reactivity against a/a plts, weak positive reactivity against a/b plts (od values . ), but strong reactivity against b/b plts (od values . ).this finding could be confirmed by one of the reference plt laboratories (japanese red cross kanto-koshinetsu block blood center, japan) using freshly isolated plts from hpa- genotyped donors (anti-hpa- b average value . ). summary/conclusions: in this study, we found anti-hpa- b in a case of fnait (patient hpa- aa, blood group o) using the maipa technique. we were able to detect the presence of hpa- b alloantibody in one case of nait. background: fetal and neonatal alloimmune thrombocytopenia (fnait) occurs in : live births in caucasians. serological and molecular human platelet antigens (hpa) genotyping tests are performed to investigate and conclude to fnait diagnosis. however, in few cases and particularly in case of suspicion of private platelet antigen, some specialized analyzes must be performed in the laboratory (lab). these analyzes can range from sanger or ngs sequencing to platelet serology with transfected cells. aims: the aim of our study was to explore where the frontier between research and care takes place in the field of platelet immunology through the prism of the fnait investigations carried out by the platelet immunology laboratories. methods: a two-part electronic survey have been sent to foreign platelet immunology experts (pie) from platelet immunobiology working party (piwp) members and espgi board members (n = ). the first part focused on the lab practices and regulatory environment regarding to accreditation, contact with patient, informed consent and patient results. the second part stressed on the investigations performed to discover new platelet antigen and more precisely on the perceived status of these analyzes ( background: haemolytic disease of the fetus and newborn (hdfn) can occur when maternal red cell antibodies, directed against red cell antigens present on the fetal red blood cells, cross the placenta and enter the fetal circulation. in a "traditionally" conceived pregnancy, when hdfn occurs, it is as a result of maternal antibodies directed against fetal red cell antigens in the heterozygous state, whereby the antigen is inherited from the father only. with the advent of donor oocyte (do) in-vitro fertilisation (ivf), the addition of a third person into the reproductive equation allows for the possibility of a more severe form of hdfn when fetal red cell antigens are present in the homozygous state (one copy from father and one copy from donor) and maternal antibodies are directed against these. antigens expressed in the homozygous state will have more antigens sites per red blood cell and therefore are at an increased risk of red cell destruction from the maternal derived cognate antibodies. aims: to raise awareness of increased severity risk of hdfn in donor oocyte conceived pregnancies. methods: we describe two unusual cases of hdfn in our institution of two women whose pregnancy was induced using a donor oocyte and their offspring requiring transfusion support in the postnatal period to treat hdfn. results: the first is a case previously reported (doyle, quigley, fitzgerald et. al. transfusion medicine, ) of protracted hdfn due to anti-c, managed with phototherapy initially, then intervention with red cell top-up transfusion at weeks post-delivery. the second is an unusual case of severe abo hdfn requiring exchange transfusion therapy (pre-publication). summary/conclusions: given the increased number of pregnancies conceived using do we recommend that antenatal guidelines are reviewed to create awareness regarding the potential increased risk of hdfn in do pregnancies complicated by allo-immunisation. critically, antenatal testing guidelines should highlight that the predicted outcomes associated with quantitation/titres can only be used when do has not been used to obtain the pregnancy. it is also essential that clinicians inform the blood transfusion laboratory when do has been used. abstract withdrawn. %) are deceased due to organ rejection, and / patients ( %) are deceased due to disease not related to rejection. summary/conclusions: the use of therapeutic plasma exchange for the treatment of antibody mediated rejection in solid organ transplant is safe and effective when used along with other treatment modalities. further studies will help determine whether it can be reproduced in larger cohorts and whether it is more effective in certain organs. background: extracorporeal photopheresis (ecp) is an important cellular therapy for the treatment of several (auto-)immune diseases such as graft-versus-host disease. the international standard for the ex vivo treatment of the leukapheresis product is the application of -methoxypsoralen ( -mop) and irradiation with uv-a light. however, the addition of -mop to the illumination bag is associated with a potential risk of contamination. aims: the basic principle of the ecp is the induction of apoptosis in the leukocytes. our aim was to find an alternative for the conventional apoptosis induction without the need of external substance application. the objective of the study was the investigation of the apoptosis levels and kinetics in leukocytes after treatment with -mop+uv-a compared to uv-c treatment without additional -mop. methods: we used an in vitro h cell culture approach with human mononuclear cells from healthy blood donors. untreated control cells were compared with , lg/ ml -mop plus j/cm uv-a treated cells and j/cm (effective dose) uv-c treated cells. apoptosis in several leukocyte sub-populations was detected daily with annexin v and -aad flow cytometry standings. results: the apoptosis analysis of cd cd t-helper cells, cd cd cytotoxic tcells, cd b-cells, cd monocytes, cd neg cd nk-cells and cd cd nkt cells revealed no statistical differences in almost all of these cell types after treatment with -mop/uv-a or uv-c light. the apoptosis kinetic as well as the final apoptosis after h were similar in both treatment groups. summary/conclusions: the addition of -mop to the photopheresis irradiation bag is a risk for potential infections. the main effect of the -mop/uv-a treatment is most probably the induction of apoptosis in the leukocytes. here, we provide information that this induction of apoptosis can also be achieved with uv-c irradiation without the need of -mop addition. the apoptosis patterns in most leukocyte subpopulations are very similar after treatment with uv-c compared with -mop/uv-a treatment. future in vivo studies are needed to prove the therapeutic effect of uv-c treated cells in the ecp setting. abstract withdrawn. background: therapeutic plasma exchange (tpe) is performed to remove the implicating substances from the plasma causing the disease. a periodic appraisal of tpe data is important to get insight into the procedural related effects and toxicities and overall outcome in order to have a guided future approach. aims: the purpose of this study is to observe the overall profile and outcome of the patients receiving the tpe in the medicine intensive care unit (micu) of a tertiary care hospital in south india. methods: a record based audit was conducted for the all the patients who were admitted to our tertiary care hospital of south india with bedded micu and received tpe therapy between june, and december . all the tpe procedures were performed using haemonetics multicomponents system (mcs) + ln apheresis system based on intermittent flow centrifugation. we audited our tpe for: number of treatments, clinical indications, treatments prescribed and administered, any procedural or patient complications, and adherence to current best practice recommendations. results: sixty nine patients had undergone tpe procedures. among them, thirty were female patients ( %). the median age ( - ) years. guillain-barre syndrome (gbs) was the most common indication ( %) followed by cases of thrombotic thrombocytopenic purpura, diffuse alveolar hemorrhage, myasthenia gravis, autoimmune encephalitis and hypertriglyceridemia respectively. the tpe regimens received by patients in this icu were not always prescribed in accordance with current best practice recommendations. there were ( %) episodes of patient related complications during the tpe treatments. in ( %) procedures, technical error in the machine was encountered. summary/conclusions: the findings of this audit have identified differences between the current prescription recommendations for tpe and those applied. the infrequency of the therapy and the different indications may present a challenge for medicine intensive care clinicians to provide best care in all cases. background: microangiopathic hemolytic anaemia (maha) encompasses a spectrum of disorders characterised by widely disseminated thrombosis in small blood vessels resulting in formation of schistocytes and concomitant thrombocytopenia. plasma exchange (pe) needs to be considered as empirical and urgent life saving therapy in these disorders irrespective of waiting for specific testing like adamts levels in thrombotic thrombocytopenic purpura (ttp) or complement levels or factor h antibodies in atypical hemolytic uremic syndrome (ahus). aims: to assess the efficacy and safety of plasma exchange in patients diagnosed as having microangiopathic hemolytic anaemias. methods: a retrospective analysis of all pe procedures performed in patients diagnosed as having maha was done over a period of years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . procedures were done on apheretic device (cobe spectra, terumo bct, lakewood co. usa). patients' pre and post procedural hematological and renal parameters were analyzed by applying paired t test. adverse event if any was recorded. results: pe was performed in patients with diagnosis of maha ( -ahus, -ttp, each of post stem cell transplantation drug induced thrombotic microangiopathy (tma), post thyroidectomy tma and post-partum tma). the mean age of patient was . ae . years with m:f as . : . number of procedures per patient varied from to . post pe recovery was observed within - days with statistically significant increase in mean platelet count from . ae . to . ae . /l (p = . ) and significant decline in mean lactate dehydrogenase level from . ae . to . ae . lkat/l (p = . ). there was also significant decline in mean percentage of schistocytes in peripheral smear from . ae . % to . ae . % (p = . ). the mean serum urea changed from . ae . to . ae . mmol/l and creatinine from . ae . to . ae . lmol/l (p = . and . respectively) with significant increase in urine output from . ae . to . ae . ml/kg/h (p = . ). adverse events were observed in patients ( %), allergic reaction to replacement fluid (n = ) being the commonest followed by hypotension (n = ), rigors and chills (n = ). overall survival rate at months was %. summary/conclusions: pe had proven its safety and usefulness as life-saving first line treatment modality in maha. prompt and aggressive treatment helps in achieving early and complete remission in these patients. background: neuromyelitis optica (nmo) also known as devic's disease or devic's syndrome is a rare demyelinating disease of the central nervous system that most often results in selective involvement of the optic nerves (optic neuritis) and spinal cord (myelitis)and has female preponderance. neuromyelitis optica (nmo) attacks are poorly controlled by steroids and evolve in stepwise neurological impairments. assuming the strong humoral response underlying nmo attacks, therapeutic plasma exchange is an appropriate technique in severe nmo attacks. aims: to study the effect of tpe in neuromyelitis optica. methods: a year old female in the medicine department, civil hospital, ahmedabad admitted with chief complains of weakness and numbness in the arms and legs, blurred vision, reduced sensation, difficulty in controlling bladder and bowels, uncontrollable vomiting and hiccups since - days in the medicine department, civil hospital, ahmedabad. attacks were treated with short courses of high doses of intravenous corticosteroid -methylprednisolone intravenous. but there was no clinical improvement. results: clinician advised for the trial of tpe in this patient. the procedure was performed by automated device with continuous flow centrifuge machine fresenius kabi-com.tec using double lumen femoral catheter. after obtaining informed consent from the relative of the patient, cycles of tpe were performed on daily basis. after cycles, both subjective and objective clinical response to tpe was estimated by three different sources (the patient, a transfusion medicine physician, and the treating neurologist). [ ] for motor performance, patient was assessed on a disability scale ( = healthy; = minor symptoms; = able to walk meters without support; = able to walk meters with support; = confined to bed or wheelchair; = requiring assisted ventilation; = dead).patient's motor performance was increased to scale (upper limb) and (lower limb) from scale , deep tendon reflexes were normal. visual function began to improve week after the treatment. visual acuity was / after weeks. summary/conclusions: assuming the strong humoral response underlying nmo attacks, therapeutic plasma exchange is an appropriate technique in severe nmo attacks. this suggests that tpe is beneficial in nmo patients during acute attack if there is no response to corticosteroid treatment. background: babesiosis is a tick borne infectious disease caused by the protozoa babesia. while most infections with babesia are asymptomatic, some patients present with a symptomatic infections and rarely this can be a severe life threatening illness. treatment is primarily with antibiotics but red cell exchange (rce) has been used in the more severe cases which are characterized by high grade parasitemia, evidence of severe hemolysis and or multi-organ failure involving the kidney, lung or liver. a threshold parasite level of % has arbitrarily been applied as an indication for rce, however, this threshold is not evidence based. aims: to report on patients with babesiosis and high grade parasitemia who were treated with antibiotics only without rce methods: data were collected from july to july . a case was defined as a patient diagnosed with babesiosis for whom rce was requested on the basis of a parasitemia of > % but on clinical evaluation it was considered that rce could be withheld and the patient monitored awaiting response to antibiotics. results: three cases of severe babesiosis in which the use of rce was requested on the basis of a parasite level of greater than %, but was not performed. the rce was deferred on account of the good clinical state of the patient and the absence of renal failure. levels of parasite at diagnosis were . %, % and %. all patients were followed daily until discharge. two of these patients had been splenectomized and each received a single unit of red blood cells during the hospitalization. the third patient had a long history of refractory lymphoma and was pancytopenic requiring multiple transfusions during the years before the diagnosis of babesiosis. she had transfusion transmitted babesiosis from a red blood cell transfused days prior to the diagnosis. all three patients responded well to antibiotics and were discharged between - days with undetectable parasites. summary/conclusions: this small case series suggests that requests for rce solely on the basis of an arbitrary level of parasitemia should be questioned and the clinical state and evidence of organ failure considered in the decision to perform rce. abstract withdrawn. chronic transfusion program (ctp) remains the gold standard therapy for stroke prevention and for patients with a severe disease who have inadequate response to hydroxyurea treatment. aims: to evaluate the safety, efficacy and cost between scd patients on ctp that underwent both aet and partial manual exchange transfusion (pmet) procedures. methods: retrospective observational cohort study of patients with scd on ctp that have switched between pmet and aet. this study was carried out from / / to / / in a hospital in portugal. data on patient history, haematological values, duration of the procedure, intervals between them, adverse events as well as the cost of material and working hours were collected and compared between both procedures. results: a total of patients met the inclusion criteria described. however, patient was excluded from our study because of the lack of attendance to the ctp. during the study, we recorded exchange procedures ( pmet and aet), both on peripheral venous access. from all those procedures the major concern was the poor venous access, which was the reason why patients had returned to pmet. no major complication or alloimmunization was observed. the indications for ctp were cerebral vasculopathy (n = ), stroke (n = ) and recurrent vaso-occlusive crisis with multiorgan failure (n = ). for both procedures, target values were to obtain a pre-exchange hbs level ≤ % for stroke and cerebral vasculopathy and ≤ - % for other indications. the median hbs level before pmet was , % ( , - , ) and , % ( , ) before aet. we documented a higher hbs level prior to the next procedure in , % of patients (n = ). despite that all patients remained stable without any major scd related event. both procedures were well tolerated and iron overload was well controlled (median ferritin level pmet: , vs. aet: , ng/ml). the duration of the exchange procedure was longer and the intervals between procedures were shorter with pmet (median pmet: vs. aet: min and pmet: vs. aet: weeks, respectively). annual rbc requirements per procedure were superior (median vs. units) and the overall costs related with aet were , times higher - . , € and . , € aet and pmet, respectively (estimated cost per session aet: , € and pmet: , €). summary/conclusions: our study shows, that the hbs level before both procedures, performed during the same interval, was similar. we verified that pmet has a comparable efficacy with aet in terms of preventing the development or progression of chronic complications and that the cost per procedure is significantly higher with aet. however, in a clinical situation where it is important to rapidly reduce the hbs level, and/or where the control of the target hbs is stricter so that the patients are clinically controlled without an increase in hospital visits, aet is preferred. we conclude that aet is more effective in the rapid reduction of hbs and ferritin levels, as well as being less time consuming. despite this, for the reasons described above, it is more cost-effective to maintain both aet and pmet procedures. background: erythrocytapheresis/red blood cell (rbc) exchange, involves removing of a large number of rbcs from the patient and returning the patient's plasma and platelets along with compatible allogenic donor rbcs. typical indication for rbc exchange is sickle cell disease and its related complications. however, one of the miscellaneous indications of rbc exchange is for the patients of methemoglobinemia who are refractory to treatment by methylene blue. acquired methemoglobinemia is more common than any genetic causes. acquired methemoglobinemia is caused by toxins that oxidize heme iron, notably nitrate and nitrite-containing compounds. for patients failing to respond to standard treatment with methylene blue or in whom its use is contraindicated; hyperbaric oxygen or rbc exchange is indicated aims: case reports on use of rbc exchange in methemoglobinemia are few and indications are based on anecdotal reports. methods: exchange was performed on the cell separator machine, com tec by fresenius kabi. results: we report a case of acquired methemoglobinemia where patient was admitted with peripheral capillary oxygen saturation (spo ) of % on air. the patient did not show improvement in spo level with effective emergency treatment of methylene blue. since, the patient was refractory to treatment with methylene blue, the decision was made by clinician to proceed with rbc exchange. the patient improved significantly after two cycles of one rbc volume automated rbc exchange, and was discharged with spo of % on air. summary/conclusions: automated rbc exchange can be used in patients of acquired methemoglobinemia successfully when methylene blue is ineffective, and may be superior to manual one. background: therapeutic plasma exchange (tpe) is known to disturb the ph and electrolyte status. patients with compromised liver functions may be at a higher risk of electrolyte imbalance due to metabolic abnormalities. aims: the aim of this study was to analyze the variation in ph, ionized calcium, sodium, potassium, and bicarbonate in liver disease patients undergoing tpe. methods: patients with liver disease undergoing tpe during the period from july to august were included in the study. data on patient demographics, details of the tpe procedure, blood gas analysis report and adverse effects of tpe (if any) were collected and analyzed. results: one hundred and seven procedures were done during the study period; of these ( %) were done on the mcs plus (haemonetics corporation) and rest ( %) were done on the spectra optia (terumo bct). the percentage change in ionized calcium, sodium, and potassium due to the procedure was found to be statistically significant (p = . ). the systolic (p = . ) and diastolic ( . ) blood pressure also changed significantly with the procedure. the predictors for the change in ionized calcium were found to be pre-procedure ionized calcium (p < . ), the age of the patient (p < . ) and the pre-procedure ph (p = . ). procedurerelated complications occurred during procedures of which complications ( . %) were categorized as features of hypocalcemia. no association was found between hypocalcemic manifestations and pre-procedure calcium, change in calcium, age or gender of the patient. summary/conclusions: the tpe procedure in liver disease patients causes remarkable changes in ionized calcium, sodium, potassium and bicarbonate ions. the decrease in ionized calcium during the procedure is predicted by pre-procedure ionized calcium levels, ph and age of the patient. monitoring of these parameters and appropriate corrective measures are imperative to patient safety. background: therapeutic plasma exchange (tpe) in pediatric age group is technically demanding because of low blood volume, difficult venous access and poor cooperation of the patient during the procedure. we here present our experience of tpe in pediatric patients from our centre. aims: to assess the challenges during tpe in pediatric patients and formulate appropriate strategies. methods: we did retrospective analysis of all tpe procedures performed in pediatric patients over a period of years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . tpe procedures were done on two different apheretic devices (cs plus, fenwal usa and cobe spectra, terumo bct lakewood, colorado) daily or on alternate days depending on clinical condition of the patient. for all procedures, kit was primed with compatible packed red cells. adverse events during the procedure were noted and analyzed. results: a total of tpe (range - /patient with mean of . procedures) were performed for pediatric patients with different indications like atypical hus (category i as per american society for apheresis (asfa) in total patients, neuromyelitis optica (category ii) in patients, rapid proliferative glomerulonephritis (category i), c glomerulopathy in patients each and one patient of infective hemophagocytosis. the average age of patient population was . yrs ( . - years) . the male:female ratio was : with an average weight of . kgs. adverse events were observed during ( . %) procedures. most commonly observed adverse events were allergic reaction to replacement fluid ( . %) followed by hypotension ( . %), line occlusion ( . %), vasovagal, endotracheal tube blockage and symptomatic hypocalcemia was observed in one procedure each ( . %).there was no corelation observed between physical parameters of patient with adverse events. all adverse events were managed as per departmental standard operating procedures (sops) and procedures were completed successfully except in one where the procedure was abandoned. no mortality was observed during the procedures. background: the hemoglobin (hb) content of packed red blood cell (prbc) units is heterogenous. the patient's blood volume is also variable which can be calculated based on the weight, height and body surface area (bsa) of the patient. the efficacy of a transfusion episode can be assessed if the hb content of prbc is known and the patient's post-transfusion hb increment is determined. aims: this prospective study was performed to compare the efficacy of the transfusion of prbcs based on hb content versus the standard transfusion practice in thalassemia major patients. we also determined the correlation between hb increment and the hb content of prbc units transfused. methods: a total of registered thalassemia major patients of our institute were included in the study after excluding the patients who had allo-or auto-antibodies. the study was approved by the institute ethics committee. the enrolled patients were randomly divided into two groups: group i (n = )they received abo/rhd identical prbcs suspended in additive solution (saline, adenine, glucose, mannitol: sagm-prbcs) after determining its hb content (units with hb content ≥ g); and group ii (n = )they received randomly selected abo/rhd identical sagm-prbcs. the hb estimation of the randomly selected units in group ii was blinded. following tests were done on pre-transfusion sample: hb estimation using the hematology analyzer (orion , ocean medical technologies, india), blood grouping using tube technique, anti-human globulin (ahg) crossmatch and direct antiglobulin test (dat) using gel technique (biorad, switzerland), antibody screening (abs) using a fully automated immunohematology analyzer (neo, immucor, usa). on the posttransfusion sample collected h after transfusion, hb estimation and dat were performed. results: there was no significant difference among the patient characteristics of the two groups. the mean hb content of the sagm-prbc units was significantly higher (p = . ) in group i (mean ae standard deviation: . ae . g; range: . - . g) than group ii ( . ae . g; range: . - . g). the mean hb increment in group i patients ( . ae . g/dl) was significantly higher (p = . ) than the group ii patients ( . ae . g/dl). in both the groups i and ii, there was a significant negative correlation between hb increment and weight (p = . in groups i and ii), age (p = . for group i; p = . for group ii), body surface area (bsa) (p = . for group i; p = . for group ii) and blood volume (p = . for group i; p = . in group ii). in both the groups i and ii, there was a significant positive correlation between hb increment and hb dose adjusted for bsa and the hb dose adjusted for blood volume (p = . in both groups i and ii for both the parameters). summary/conclusions: the efficacy of transfusion is more when patients are transfused with sagm-prbcs having hb content of g or more as compared to those who are transfused with randomly selected units. for optimal hb increment in thalassemia major patients, the transfusion strategy should be based on the hb content of the sagm-prbcs. background: in male transfusion recipients under years of age, receiving red blood cells (rbcs) from an ever-pregnant blood donor has been associated with increased mortality, compared to receiving a product from a male donor. although it has been suggested that older units of rbcs could be associated with increased mortality, there are significant methodological challenges in these studies. other studies indicated the freshest units of rbcs could be associated with increased mortality among transfusion recipients. we hypothesize both the association between ever-pregnant donors, and fresh units, with mortality could be caused by passenger leukocytes in the transfused rbc units, which decay during storage. aims: to quantify modification of the effect of ever-pregnant donors on mortality in young male rbc transfusion recipients, by storage time. methods: data on transfusion recipients receiving their first-ever rbc transfusion in one of six major dutch hospitals between / / and / / was collected. for the current study, male transfusion recipients under years receiving only transfusions from one donor sex exposure category were selected and followup was censored at three years after transfusion. differences in storage time between groups were estimated by linear regression, adjusted for total number of transfusions, patient age, blood group, transfusion year and month. in a single-unit, single-transfusion cohort, cumulative mortality was estimated separately for patients receiving transfusions from ever-pregnant or male donors and for 'fresh' (< days storage) or 'old' (> up to days storage) rbcs. results: for recipients of only blood from male donors, the storage time of the freshest unit was . day shorter when comparing the patients who died, to , patients who survived (ci: À . to . ). for recipients of only blood from ever-pregnant donors, the storage time of the freshest unit was . day longer when comparing the patients who died, to patients who survived (ci: À . to . ). in the single-transfusion cohort, , patients received a fresh rbc transfusion from a male donor, of whom died; patients received a fresh transfusion from an ever-pregnant female donor, of whom died. patients received an old transfusion from a male donor, of whom died; patients received an old transfusion from an ever-pregnant female, of whom died. the -years cumulative incidence of death among young male recipients was . % (confidence interval (ci): . % to . %) after a fresh transfusion from a male donor and . % (ci: . % to . %) after a fresh transfusion from an ever-pregnant female donor. the -years cumulative incidence of death was . % (ci: . % to . %) after an old transfusion from a male donor and . % (ci: . % to . %) after an old transfusion from an everpregnant female donor. summary/conclusions: prolonged storage of rbcs from ever-pregnant donors was not associated with decreased mortality at years. contrary to our expectations, our results indicate older units may potentiate the effect of ever-pregnant donors. however, due to limited sample size the observed differences were not statistically significant. background: according to the literature review, there was limited impact of premedication (antipyretics, antihistamines and steroids) before transfusion on the prevention of adverse transfusion reactions (atrs). however, the necessity of premedication remains controversial. the premedication before transfusion is still a common clinical practice in pacific-asian countries, along with the premedication rate ranging from to %. in our previous investigation, we found that premedication rate was . % in the outpatients in , which was much higher than the reported rate in asia. aims: to investigate the incidence of atrs and decrease premedication rate without increasing the rate of atrs via education and evidence-based clinical practice. methods: the incidence of atrs from april to december, was retrospectively surveyed. evidence-based clinical practice was initiated since january, . clinical data of the outpatients receiving transfusion therapy were requested and analyzed from january to september, . the incidences of atrs and premedication rates in and were compared using chi-square test. a p value less than . was statistically significant. besides, feedback of the incidence of atrs and premedication rate was given quarterly to the clinicians during the investigation. results: from april, to september, , a total of , blood units were transfused in the outpatients with , transfusion events. of these, cases of atrs, including febrile nonhemolytic transfusion reactions (fnhtr) and minor allergic reactions were reported. the overall premedication rate in the outpatients was . % in , and was significantly decreased to . % in (p < . ). it was reported that the incidences of atrs in and were . % and . % per unit, respectively. there was no remarkable difference between the incidence of atrs in and (p = . ). summary/conclusions: via education and evidence-based clinical practice, we successfully reduced premedication rate without increasing the rate of atrs in the outpatients. furthermore, introduction of computerized provider order entry (cpoe) and clinical decision support system (cdss) could be considered and be expected to prevent unnecessary premedication before transfusion, increasing the compliance with optimized transfusion strategies in the future. methods: a retrospective analysis was done over a period of one year to evaluate clinical efficacy of granulocyte transfusions in hemato-oncology patients with febrile neutropenia. mobilization of granulocyte donors was done as per standard protocol, which included subcutaneous injection of granulocyte colony stimulating factor (g-csf) - lg/kg and tablet dexamethasone mg, - h prior to granulocyte harvest by apheresis. all granulocyte products were gamma irradiated before transfusion. patient parameters like white blood count (wbc), absolute neutrophil count (anc), hemoglobin and platelet count were recorded pre-and post-granulocyte transfusion. infection related mortality (irm) within days of granulocyte transfusion was also recorded. results: minimum adequate granulocyte yield of per unit was fulfilled in % of granulocyte harvests. clinical indications for granulocyte transfusions were fever, an absolute neutrophil count (anc) < /ll, evidence of bacterial and/or fungal infections (i.e. clinical signs of infection, positive cultures and radiological evidence) and unresponsiveness to appropriate antimicrobial therapy for at least h. effects of clinical, microbiological and granulocyte transfusion related variables on infection-related mortality were investigated. the post transfusion anc (within h) increased significantly (median value: /ll) as compared to baseline levels (median value: /ll) (p < . ). infection related mortality was observed in only % ( out of ) of patients. patients became afebrile within - days and culture negative within - days after granulocyte transfusion. for analysis purpose granulocyte transfusion episodes were grouped according to doses of granulocyte transfusions, based on european guidelines (standard dose: . - . cells/kg and high dose: > . cells/kg background: hsa's blood services group (bsg) is singapore's national blood service. in , we conducted our pilot national pbm audit to promote pbm practices. it was agreed that the audit would be performed annually with incorporation of a new indicator to continue promotion of pbm and sharing of good practices. aims: to provide an update on the second national pbm audit for . results are compared to the pilot audit and summarized below. methods: we collected data on performance indicators from acute public care hospitals for weeks each in march and august (the pilot audit covered weeks in ). the performance indicators were: ). percentage compliance to documentation of red blood cell transfusion indications ). percentage of patients screened for pre-operative anaemia, to days before surgery ). peri-operative transfusion rates ( days before to days after surgery) for commonly performed surgeries: coronary artery bypass graft surgery (cabg), total knee replacement (tkr), total hip replacement (thr), nephrectomy, colectomy and hysterectomy. the first two indicators assess pbm efforts and were measured in the pilot audit. indicator ) was added to the second audit to assess impact of pbm practices on transfusion in surgical patients. it was an appropriate time to incorporate this indicator as the hospitals would have been familiar with pbm since its introduction in . results and recommendations were shared with the senior management and hospital transfusion committees of the participating hospitals. results: for indicator ), hospitals had a compliance of - %, the remaining had a compliance of - %. all hospitals incorporated electronic blood ordering but the usage was not compulsory in some. hospitals which mandated electronic ordering performed better as doctors could only order blood products after entering the transfusion indication. we saw compliance increase from % in to % in a hospital that had newly mandated electronic ordering. for indicator ), results ranged from % to %. hospitals made notable improvements when compared to , achieving % and % respectively. they had implemented pre-operative workflows screening all elective surgical cases for anaemia at least weeks before surgery. one hospital also started an outpatient intravenous iron service which reduced pre-operative anaemia rates. for indicator ), mean number of transfused units for each surgery ranged from . to . units per patient, lowest being thr and highest being cabg. this suggests that some transfusions were potentially avoidable with more robust pbm practices. the rate of perioperative transfusions was highest for cabg at % and lowest for tkr at %. summary/conclusions: the annual national pbm audit increases pbm awareness, allowing hospitals to share and learn good practices and implement measurable improvements. based on this audit, a recommendation to mandate electronic ordering of blood products to improve adherence to red cell transfusion indications and implementing pre-operative workflows with consideration for intravenous iron support was made. this audit was more representative than the pilot, with a longer duration of data collection and incorporation of indicator ) showing impact of pbm practices. background: autoimmune haemolytic anaemia (aiha) is a decompensated acquired haemolysis caused by the host's immune system acting against its own red cell antigens. aiha is a rare disorder and although british society of haematology (bsh) guidelines for diagnosis and treatment were published in february , there is little evidence for clinical practice in the united kingdom. aims: to investigate the approach to the diagnosis, investigation and management of patients with autoimmune haemolytic anaemia (aiha) in english nhs trusts. methods: we designed and distributed a survey to the clinical transfusion leads at all english nhs trusts between november and march . the survey requested information on detailed, simulated clinical scenarios. the first simulated scenario described a young patient with active aiha months after an allogeneic stem cell transplant, who has received multiple transfusions in the last weeks and is hypotensive, tachycardic, with a falling haemoglobin (hb), currently g/l. the second scenario describes a young man with a new diagnosis of warm aiha who has an initial hb of g/l and returns to clinic at a -week interval with symptoms of fatigue. he is actively haemolysing and commenced on mg/kg prednisolone. results: there was a % ( / ) response rate by trusts. faced with a - h delay for allo-adsorption studies, % ( / ) of respondents would instead transfuse acutely with abo, rh and k matched red cells negative for any previously detected alloantibodies, % ( / ) would transfuse with o rh d negative red cells and % ( / ) would wait for completion of allo-adsorption studies before transfusing. in this first scenario, a quarter of respondents appeared to delay a potentially lifesaving blood transfusion. british society of haematology guidelines recommend that when anaemia is life-threatening in the time required for full compatibility testing, abo, rh and k matched red cells should be transfused. in the serious hazards of transfusion (shot) report, the most serious and fatal of cases of preventable delayed transfusion was a patient with aiha who died untransfused with an hb of g/l, while awaiting alloadsorption studies. a key shot message was that if clinical harm to patients from withholding blood outweighs safety concerns over a possible delayed haemolytic transfusion reaction, emergency blood is essential and should be offered. the second scenario also identified considerable variation in transfusion practice. it can take several weeks for patients with aiha to respond to prednisolone so a transfusion threshold < g/l after an hb fall of at least g/l in the previous weeks is perhaps overly conservative. summary/conclusions: the overall findings support a need for studies to explore barriers to uptake of guidelines, and to identify areas for further audit and research to guide safe and appropriate transfusion practice in aiha. background: balance between supply and demand of o d negative red cells remains a challenge for almost every blood service. with this re-audit, we wanted to collect objective and comprehensive information regarding usage of o d negative red cells supplied by nhs blood and transplant (nhsbt) to private and nhs hospitals in england. aims: the aim was to understand hospital practices, actual needs and possible avoidable usage of o d negative red cells. where possible, comparisons were made with two previous audits ( ) ( ) ( ) . methods: participating hospitals were asked to determine the fate of all group o d negative red cells they received between th and th may excluding substitutions and complete an organisational survey regarding activities, policies and stockholding practices with respect to o d negative blood. participating hospitals were asked to provide (if available) the prevalence (as a percentage) of o d negative patients in their population. this information, in conjunctions with hospital activities, will be used to estimate appropriate o d negative stockholding levels. background: o rhd-negative (neg) red blood cells (rbcs) are a precious resource, are often in short supply and transfusion of these units in emergency settings carries the potential risk of transfusion-related adverse outcomes such as haemolytic reaction due to minor blood group incompatibility. as such, their use should be closely monitored within health services. most recent australian guidelines ( ) for their use in emergency settings include pre-menopausal females of unknown blood group (mandatory indication) or while the blood group is being established; use should be limited to or less units where possible before a switch to group-specific rbcs (acceptable indication). aims: audit of use of emergency uncrossmatched o rhd-neg rbcs against national guidelines in our institution (an australian tertiary metropolitan public hospital providing acute medical and surgical, emergency and critical care services). methods: use of emergency uncrossmatched o rhd-neg rbcs units over a six-year period was retrospectively reviewed. we collected information about rbcs transfused and discarded, adverse outcomes, patient characteristics, clinical indications and whether use met national guidelines or could have been avoided. results: episodes of emergency uncrossmatched o rhd-neg rbcs were identified, encompassing transfusion of rbc units to patients and the discard of rbcs (due to incorrect transport). of the episodes, episodes ( %) involved an eventual switch to group-specific rbcs (range of emergency units, - units). the main requester was the emergency department ( %). the most common clinical indication for transfusion was acute gastrointestinal bleeding ( %). of the episodes, episodes ( %) did not meet the guidelines for emergency use because > units of emergency uncrossmatched o rhd-neg rbcs were issued. episodes ( %) were flagged as potentially inappropriate as the patients were clinically stable according to documentation in the medical records. episodes ( %) were identified as potentially preventable due to delay in pre-transfusion sample collection (defined as > h elapsed between patient arrival and group and screen sample collection) in the setting of acute bleeding ( %), receipt of an unsuitable pretransfusion sample requiring sample recollection ( %), delay in pre-transfusion sample processing ( %), no valid pre-transfusion sample being available at the time of the bleeding episode despite having a planned elective procedure or being an inpatient with recent clinical bleeding ( %). only one patient was investigated for potential transfusion-related adverse outcome ( %) which was thought likely due to concurrent sepsis. summary/conclusions: over six years, episodes utilising emergency uncrossmatched o rhd-neg rbcs were identified with rbcs issued and rbcs discarded. a significant proportion of episodes ( %) were potentially avoidable if there had been a valid pre-transfusion sample available in the transfusion laboratory at the time of the episode. efforts to minimise use of this precious resource are ongoing, and include feedback to clinical units regarding importance of valid pretransfusion samples prior to applicable invasive procedures and in bleeding patients, ongoing education to medical and nursing staff, and continuing audit of use of this blood component in the hospital haemovigilance programme. abstract withdrawn. abstract withdrawn. background: platelet transfusions are often given prophylactically to thrombocytopenic hematology patients. to which extent platelet function improves after transfusion, and how this improvement correlates with an increase in platelet count, is not well studied. flow cytometry has been used to evaluate platelet function after transfusion in a few studies and can be performed even at low platelet counts. rotational thromboelastometry (rotem) represents a more physiological measure of platelet function in whole blood that has not been extensively used in transfusion settings. we used these methods to investigate if platelet transfusion improves platelet function in hematology patients and if improvement correlates with increased platelet counts. aims: the aim was to evaluate the relationship between response to platelet transfusion, measured as corrected count increments (cci), and platelet function in thrombocytopenic patients with hematological disorders. methods: blood samples (sodium-citrate anticoagulated) were collected from unselected hematology patients receiving prophylactic platelet transfusions, after informed consent had been obtained. samples were taken at three time-points: within h before transfusion, h after and - h after transfusion (via a central venous catheter or a subcutaneous venous port). for each time-point, platelet response to adenosine diphosphate (adp) and thrombin receptor-activating peptide (trap- ) was assessed by flow cytometry by measuring p-selectin and pac- expression on single platelets. rotem analysis was also performed on all samples, using intem and extem reagents. results: an interim analysis was performed after inclusion of patients. the mean platelet count before transfusion was /l (range - /l). h cci was /l and - h cci was /l, but response was highly variable. pselectin expression after stimulation with adp and trap was significantly higher at h after and - h after transfusion compared to before transfusion (p < . ). pac- expression after stimulation with adp was significantly higher at - h after transfusion (p < . ), but not at h after transfusion. in rotem, clot amplitude at and min (a and a ) as well as maximum clot firmness (mcf) improved after transfusion (p < . ). a significant correlation between absolute platelet count and p-selectin expression after trap and adp stimulation was found (r s = . and . respectively, p < . ). absolute platelet count was also significantly correlated with mcf (r s = . , p < . ), where % of patients with a platelet count of more than /l reached mcf values within the reference interval. summary/conclusions: platelet function generally improves after transfusion and was in our patient population correlated to the absolute platelet count, but was also seen at the single platelet level in flow cytometry. a post transfusion platelet count of more than /l might be sufficient to significantly improve coagulation in heavily thrombocytopenic patients, but larger studies are needed to confirm this conclusion. abstract withdrawn. abstract withdrawn. background: sickle cell disease (scd) is a genetic disorder that is frequently referred to as a hypercoagulable state. hydroxyurea (hu) is known to decrease the frequency of vaso-occlusive complications and need for blood transfusions in severely affected individuals. although cross-sectional studies show that treatment with hu is associated with decreased coagulation activation, there are no prospective studies evaluating the effect of hu on coagulation activation. aims: to assess the effect of hu on markers of fibrinolysis (d-dimer) and endothelial activation (soluble vascular cell adhesion molecule- [soluble vcam- ]) in patients with scd in their non-crisis, "steady state." methods: patients, at least years of age, with documented hbss or hbsb-thalassemia, eligible for treatment with hu were studied in this prospective, observational study. laboratory investigations were obtained at baseline, prior to commencement of therapy with hu, with repeat evaluations at three and six months of therapy. non-parametric test was applied to observe the association between hu therapy and the biomarkers of interest. results: twenty-five patients with scd (hbss: , hbsb thalassemia: ) were enrolled (females: [ %]), with a median age of years (iqr: ). following months of hu, median values for wbc count ( . /l vs. . /l, p = . ) and d-dimer ( . ng/ml vs. . ng/ml, p = . ) were significantly lower than baseline values, while the mean corpuscular volume ( . fl vs. . fl, p = . ) was significantly higher than the baseline value. no significant differences from baseline were observed in the median values for hemoglobin ( . g/ dl vs. . g/dl, p = . ), platelet count ( /l vs. . /l, p = . ), lactate dehydrogenase ( u/l vs. . u/l, p = . ) or soluble vcam- ( . ng/ ml vs. . ng/ml, p = . ) following months of hu therapy. summary/conclusions: this exploratory study confirms that treatment with hu is associated with decreased coagulation activation in patients with scd, although no effect on endothelial activation was observed. by decreasing coagulation activation, hu may decrease the risk of thrombotic complications in scd. abstract withdrawn. abstract withdrawn. transfusion medicine, apollo gleneagles hospitals, kolkata, india background: reduction of immune responsiveness through blood transfusion has been documented by previous authors. breast cancer is considered as one of the commonest cancer globally and the second main cause of death in females transfusion of allogeneic blood in breast cancer surgery is variable and differences of transfusion incidence have been observed in the literature. where the maximum surgical blood ordering schedule (msbos) dictates cross matching and reservation of blood before surgery, factors deciding their utilization are varied and numerous. our hospital protocol guides that every patient planned for elective breast cancer surgery should routinely have a blood sample sent for reservation of one unit of compatible packed red blood cell (prbc) in the blood bank. aims: in this prospective study we aimed to audit the blood utilization in patients undergoing elective breast surgery and thereby optimize the blood ordering schedule, economic burden and loss of clinical resources. methods: the study included confirmed breast cancer patients planned for elective breast surgeries from january to december . patient and disease details like age, stage, tnm status, estrogen receptor (er) and progesterone receptor (pr) status, human epidermal growth factor receptor (her - ) expression, triple negative breast cancer (tnbc) status, reproductive and treatment status were documented. patients were divided into younger group [≤ years] and older group (> years). before surgery blood samples for compatibility testing were sent to blood bank for blood reservation. details of test, blood issue and blood transfusion were documented in the blood bank. approximate loss of time in minutes and wastage of resources in terms of money (inr) in the blood bank were noted. all results were calculated as mean ae sd and a 'p' value of < . was considered statistically significant. results: of the total patients most underwent wide local excision of the breast and modified radical mastectomy. a total of patients received units of blood and blood components in all categories of surgeries. only were younger women (≤ years) with mean age of years. non-transfused patients were significantly more than transfused ones (p < . ). frequency of blood transfusion was more in young patients ( . %). seven ( . %) of the total stage iv patients received blood transfusions. frequency of blood transfusion was more in patients undergoing surgery after chemotherapy ( . %). a significant loss of time and loss of revenue was observed. summary/conclusions: we conclude that routine compatibility test is not justified for all patients undergoing breast surgery. a more targeted approach is needed to reduce blood demand and associated cost to patient and blood transfusion services. background: blood transfusion guidelines are not only essential for the optimal use of blood products, but also help reduce transfusion-related adverse reactions and improve patient outcomes. the korean national transfusion guidelines were developed in and fully revised in by the korean centers for disease control and prevention and the korean society of blood transfusion. in our hospital, which is a -bed university hospital, a transfusion-indication data-entry program based on the national transfusion guidelines was developed in . it was applied to the electronic medical record system and all transfusion orders, except emergencies, have been performed through this program since then. aims: we planned to record and analyze the reasons for transfusion in order to monitor blood product usage and provide feedback to clinicians. furthermore, we intended to contribute to patient safety through the appropriate use of blood products. methods: we classified transfusion-indications by the blood product requested and created a pop-up window listing these indications, which would appear at each regular transfusion order. indications for transfusion with each blood product were as follows: red blood cells (rbcs)acute blood loss, chronic disease (sub-classified as hb ≤ g/dl, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, respiratory disease, age ≥ years, age ≤ months, chemotherapy), surgery/ procedure, transplantation and 'other'; platelets (plts)present bleeding, bleeding prevention (sub-classified as hematologic disease, solid tumor, peripheral blood stem cell transplantation, disseminated intravascular coagulopathy, infant), surgery/procedure, massive transfusion and 'other'; fresh frozen plasma (ffp)bleeding in coagulopathy, bleeding prevention in coagulopathy, massive transfusion, plasma exchange and 'other'. transfusion indications entered into the data-entry program from sep to feb were analyzed. results: the number of transfusion-indications analyzed was for rbcs, for plts and for ffps. the most common indications for transfusion were chronic disease for rbcs ( / , . %), bleeding prevention for plts ( / , . %) and 'other' for ffp ( / , . %). 'hb ≤ g/dl' was the most frequent sub-indication of chronic disease ( / , . %), and hematologic disease was the most frequent sub-indication of bleeding prevention ( / , . %). many clinicians entered transfusion indication as 'other': rbcs ( / , . %), plts ( / , . %) and ffp ( / , . %). however, the free-text supplied by the clinician when 'other' was selected, often corresponded to an indication already categorized in the transfusion-indication data-entry program; . % of rbcs and % of plts. of the indications entered as 'other' in ffp, . % were surgery/procedure-related. summary/conclusions: in our hospital, the release of blood products has been dependent on the data-entry of transfusion indications (except in emergencies) since sep . transfusions of rbcs and plts were most common for chronic disease and bleeding prevention, respectively, but many cases entered as 'other' could have been categorized as existing indications in our data-entry program. therefore, we conclude that additional training is needed for clinicians regarding the determination of transfusion-indications and correct use of the transfusion-indication dataentry program, in order to use blood products more appropriately. methods: this was a prospective cohort designed study. subjects were children aged - years with indication of platelet transfusions in sardjito hospital yogyakarta indonesia. the patient samples were collected before and h post-transfusion, the expression of cd p on platelet was determined by flow cytometry method. results: there were subjects who were divided into two groups. fifty-one subjects received non-leukodepleted pcs and the other fifty-one transfused by pre-storage leukodepleted pcs. the mean of pre-transfusion platelet cd p for nonleukodepleted and leukodepleted groups were . % and . %, and the mean increase of post-transfusion platelet cd p for non-leukodepleted was . % and the mean decrease of leukodepleted groups was . %. it was shown the increase of post-transfusion platelet cd p for non-leukodepleted group, and it was significantly (p < . ) higher than in the leukodepleted groups. summary/conclusions: there was an increase of post-transfusion platelet cd p expression in patients received non-leukodepleted, but a decrease in leukodepleted pc transfusions. background: preoperative anaemia is a common finding in patients undergoing surgery and often neglected in our country. aims: the objective of this study was to evaluate hb(values and the identification of cardiac patients who entered operation with anaemia. and also to study the correlation between hb values and the number of rbc (red blood cell) transfused unit methods: this is a retrospective, descriptive and analytical study. the data for this study was collected from the files in the statistic's service at qsut (university hospital center "mother teresa"). the object of our study were the files of patients hospitalized in the period january -may in the cardiac surgery ward, which were subjected to cardiac surgery. from the files were collected data on age, gender, primary diagnosis, accompanying diseases. we also collected hb, rbc, htc (hematocrit), mcv (mean corpuscular volume), mch (mean corpuscular hemoglobin), mchc (mean corpuscular hemoglobin concentration). from the transfusion service at qsut and from the files were pulled out the transfused patients and the number of transfused units. results: based on the who definition for anemia (females < g/dl and males < g/dl), from the patients included in the study, ( %) were anaemic. from males in the study, ( %) of them were anaemic based on hb lab values, whereas from women in the study anaemic were found to be ( %) of them. from the anaemic patients in the study, ( . %) of them with mild anaemia, ( . %) with moderate anaemia and ( . %) with severe anaemia. in the total of anaemic female . % are under , while . % are over/or years old. in the total of anaemic males, % are under , while % are over/or years old. it is noticed that most of them are with normochromic normocytic . %, normocytic hypochromic anaemia . %, hyperchromic microcytic anaemia . %, macrocytic normochromic anaemia and macrocytic hypochromic anaemia respectively . % and microcytic normochromic anaemia . %. the average value of preoperative hb decreased from . g/dl before surgery to . g/dl after surgery, so there is a decrease of approximately . g/dl of hb value. in our patients, % ( ) were transfused and the remaining % ( ) were not transfused. from transfused patients ( %) patients were anaemic. the correlation between the values of hb, rbc, htc and the number of transfusions shows that with the decrease of these values the number of transfused units increases. summary/conclusions: the diagnose of anaemia is underestimated before surgical intervention in our country and investigation of hb low values do not take the proper importance to find probable cause and correct it before surgical intervention. the lower the hb values, the greater the chance to be transfused and the number of rbc transfused units. failure to correct hb values before surgery results in unnecessary transfusions for the patients or which could have been avoided, eliminating also the risk of transfusion complications. background: alloimmunization after red blood cell transfusion is affected by various factors. it is known that the incidence of alloimmunization increases in certain diseases. extended red blood cell matching can be used to prevent the development of alloimmunization in diseases which the rate of alloimmunization is increased. in asia, extended red blood cell matching is not actively implemented. aims: we tried to investigate whether there is a difference in the disease categories between unexpected red blood cell antibody positive and negative groups. methods: from january, to december, , the diseases of the patients who had undergone unexpected red blood cell antibody identification test at dong-a university hospital was examined through medical records. from january to december , the diagnosis was made on patients who had two or more unexpected antibody screening tests. we analyzed the frequency difference of disease category between two groups. results: a total of patients were performed with unexpected antibody identification tests. of patients who underwent more than screening tests, ( . %) were positive. were consistently unexpected antibody negative. the patients with solid tumors (n = , . %) and those with hematologic diseases (n = , . %) had a higher incidence in unexpected antibody positive group. the patients with myeloid malignancy had a significantly higher frequency than lymphoid malignancy (p = . ). the frequency of patients with liver cirrhosis was significantly higher in the unexpected antibody positive group ( / , . %) than in the negative group ( / , . %) (p = . ). the incidence of non-hodgkin lymphoma was significantly higher in the unexpected antibody negative group ( / , . %) than in the positive group ( / , . %) (p = . ). summary/conclusions: there was a difference in the distribution of diseases between unexpected antibody positive group and negative group. the patients with liver cirrhosis were more frequent in unexpected antibody positive group, suggesting that extended red blood cell matching would be considered. background: in hematological patients with multiple platelet transfusions (pc) often develop immune response to human leukocyte associated antigens (hla-i) and human platelet-specific associated antigens (hpa). besides, platelet associated immunoglobulins (paig) and complement components (pac) are found on platelet. this leads to increased platelet destruction and development of refractoriness to transfusions of donors' platelets. transfusion therapy using an individual selection of platelets and plasmapheresis, contribute, in the majority of cases, to the realization of efficient transfusion by pc. but, in difficult cases, there is a need to use intravenous immunoglobulin, which may promote the efficient transfusion of pc. aims: evaluate the algorithms of using the complex therapy of refractoriness to transfusions of donors' platelets with additional application of intravenous immunoglobulin (ivig). methods: in there were three female patients in the clinics of the centre for observation, age between and years (me = ) with the ineffectiveness of complex therapy for overcoming refractoriness to transfusions of donors' platelets due to selection and plasmapheresis. the diagnoses were as follows: aplastic anaemia (aa)- , acute myeloid leukemia (aml)- . individual selection of platelets was carried out by the adhesion method on the solid phase (immucor "galileo neo"). paig and pac / were evaluated by the method of flow cytometry (bd facscanto ii) by the method of double staining with cd a. the density of fixed paig, pac was © the authors vox sanguinis © international society of blood transfusion vox sanguinis ( ) (suppl. ), - evaluated by the median fluorescence intensity (mfi). the two patients with aa received ivig-igg therapy in the standard dose , g/kg per day, for days. one patient with aml received ivig-iggam therapy in the standard dose , ml/kg/day for . results: under pressure of the complex therapy with the use of ivig in the standard dose there was are decrease in mfi over time in the case of two patients: aa- mfi-paigg reduced from to ; while the patient with aml: paiga reduced from to , and paigm from to , pac from to , pac from to . the patient with aa- over time, regardless of the treatment, there was an increase of mfi, but the effect of pc transfusions was achieved under pressure of complex therapy. under pressure of complex therapy all the patients also reduced the frequency of reaction of alloantibodies when resorting to an individual selection and increasing the frequency of compatible couples "donor-recipient". summary/conclusions: delivery of complex therapy and the additional application of ivig enables an adequate transfusion therapy of pc, neutralize hemorrhagic syndrome and continue the treatment of the main disease. detection and monitoring of paig/pac during the development of refractoriness to transfusions of donors' platelets are additional markers for prescription of ivig therapy. anaesthesia, tan tong seng hospital, singapore, singapore background: blood transfusion is quite prevalent in paediatric cardiac surgical procedures. we hypothesized that the routine use of rotational thromboelastography (rotem) to guide transfusion decisions would reduce the overall proportion of patients receiving transfusions in paediatric cardiac surgery aims: the aim of the study was to find if the use of blood and blood products in pediatric cardiac surgical cases in a single centre is affected due to rotem. methods: sixty paediatric cardiac surgical patients undergoing cpb were included in this study. thirty patients (study group) were prospectively included and compared with thirty procedure and age-matched control patients (control group). in the study group, rotem, performed during cpb guided intraoperative transfusions. perioperative transfusions of blood and blood products, postoperative blood loss and hemoglobin levels were compared between the two groups. results: the patients in the control group received fewer transfusions of packed cells ( % vs %) and fresh frozen plasma ( % vs % p mmhg. sheep were euthanised h after resuscitation. data are presented as mean ae standard deviation. results: sheep were haemorrhaged an average of . ae . ml blood which combined with iatrogenic blood loss (~ ml) corresponded to an average . ae . % blood loss. two out of the four sheep met clinical criteria for haemorrhagic shock (map = - mmhg, lactate > mm, svo < %). across all four sheep the nadir map averaged . ae . mmhg, lactate peaked at . ae mmol/ l, and nadir svo was . ae . %. all sheep survived to the end of the experimental protocol. summary/conclusions: these data demonstrate the successful induction of haemorrhagic shock in an ovine model. further experiments are planned to improve the protocol and to achieve % incidence of haemorrhagic shock, and then to compare invasive and non-invasive measures of oxygen delivery and utilisation as well as the efficacy of different resuscitation fluids and red cell transfusion. adverse events, including trali p- bilirubin were recorded within the -day period. the clinical parameters were compared against the reaction strength of the antibody reactions. the automated strength was measured by solid phase. the manual testing consisted of a -min incubation using liss and adding monospecific igg. the dat was performed manually by adding poly-specific igg and then testing with monospecific igg and c d. the rh group and non-rh group had and cases performed manually, and results were + or weaker further indicating the manual strength did not correlate with the clinical hemolysis. likewise, in / ( %) the dat was negative, and did not show any correlation with clinical hemolysis. however, when ldh and bilirubin were measured, the two parameters increased as the automated strength of the antibodies increased. summary/conclusions: most of the dshtr investigation was not associated with overt accelerated red cell destruction. a strong correlation was observed only between the automated immunohematology testing results and other laboratory markers of hemolysis. in our experience, the direct antiglobulin test and manual strength showed no correlation. background: numerous transfused patients present severe, sometimes critical clinical conditions. the occurrence of adverse transfusion reactions (atr) may induce deterioration in the clinical condition with a worsened clinical course and a lifethreatening or fatal outcome as is the case with nervous system impairment. in france, in , out of , notified atrs, ( . %) and ( . %) were life-threatening and death respectively. aims: our aim was to evaluate the notified atrs with neurological signs that occurred in transfused patients over a period of six years and six months in hospitals in the auvergne rhône alpes area. the study included patients with reported atrs in hospitals in this area from january st to june th . each atr was registered in the national haemovigilance database system. two signs observed at the time of the atr were analyzed: unconsciousness and convulsions. stroke was excluded. the type of atr, its severity, the blood product involved and its imputability were studied. results: during the period under study, , atr were reported, of which included unconsciousness and/or convulsions ( . %). of these patients, were females ( . %) and males ( . %). unconsciousness alone was frequently observed ( reports, . %). convulsions were notified in reports ( . %) and were associated with unconsciousness in of them. the diagnosis of seizure, with no other clinical signs, was established in cases ( . %). unconsciousness and/or convulsions were present in allergic reactions ( . %), cases of transfusion-associated circulating overload ( . %), cases of suspected transfusion-transmitted bacterial infections and hypertensive reactions. in allergic atrs, unconsciousness was notified in cases and unconsciousness associated with convulsions in one. twelve atrs were severe ( . %), were life-threatening ( . %) and in cases, they resulted in the death of the recipient ( . %). of the allergic atrs, were severe and life-threatening. red blood cell concentrate was involved in atrs ( . %) and platelet concentrate in ( . %), including cases with apheresis platelet concentrate and cases with pooled platelet concentrate. fresh frozen plasma was involved in atrs ( . %). nevertheless, the imputability of the blood product was excluded or unlikely in atrs ( . %). in the suspected transfusion-transmitted bacterial infections, the imputability of the transfusion was ultimately excluded after a negative result was obtained in the bacterial culture of the blood product. the imputability of the blood product was probable or possible in and atrs respectively, but was certain in only atrs. summary/conclusions: unconsciousness and/or convulsions were rarely observed in atrs notified in transfused patients. nevertheless, the presence of these signs highlights the seriousness of the atr ( ars, . %). lastly, the imputability of the blood product was often excluded or unlikely. in the multivariate cox model for the effect of lpi on overall survival, adjusted for age and ipss-r category, elevated lpi levels were associated with inferior overall survival (hr . , % ci . - . , p = . ). this effect was most pronounced in the td-rs subgroup (hr . , % ci . - . , p < . ). similarly, elevated lpi levels were associated with inferior pfs (hr . , % ci . - . , p < . ) for the whole study population and the td-rs subgroup (hr . , % ci . - . , p < . ). in total patients received iron chelation during the sample collection period ( patients deferasirox, patients desferrioxamine). lpi levels were normal in out of the samples collected during deferasirox treatment and in out of samples collected during desferrioxamine treatment. summary/conclusions: transfusion dependency is associated with the presence of toxic iron species and inferior overall and progression-free survival in lower-risk mds patients. in td-rs patients the effects were most pronounced indicating ineffective erythropoiesis leading to additional iron toxicity. background: post-transfusion immunomodulation has been reported to contribute to poor patient outcomes. clinically relevant transfusion models are needed to improve our understanding of underlying mechanisms. sheep transfusion models are of increasing importance in blood transfusion research as they provide several advantages over small animals, including their size, anatomy, physiology and similar blood volume compared to human. a current limitation of sheep transfusion models is the lack of characterisation of the sheep immune system. understanding the sheep immunology is necessary to advance sheep transfusion models, identify mechanisms that contribute to post-transfusion immunomodulation and facilitate the translation of findings into clinical settings. aims: to characterise the sheep leukocyte inflammatory responses to in vitro lipopolysaccharide (lps) challenge in edta and heparinized whole blood. methods: edta and heparinized sheep whole blood (n = of each) was cultured with rpmi media ( °c, % co ) alone or with the addition of lps ( - lg/ml; derived from escherichia coli : b ). the inflammatory response was assessed after h (h), h, h, h, h and h. supernatant was harvested at each time point and stored at À °c. inflammatory cytokine/chemokine production was determined using sheep specific in-house elisa (il- b, il- , il- and il- ). twoway analysis of variance with bonferroni's post-test was used to measure the effect of incubation time and concentration compared to no lps matched samples. results: when edta was used as an anticoagulant, addition of lps resulted in production of sheep il- b and il- but not il- or il- . il- b production was significantly increased following stimulation of lg/ml lps for h (p = . ) and declined following h incubation. release of il- was significant h post-lps stimulation with lg/ml (p = . ) and reached a maximum at h. the use of heparinized blood resulted in a different immune profile as all inflammatory markers tested were detected following stimulation with much lower concentrations of lps ( lg/ml), although the incubation times differed. il- b was significantly increased following h incubation (p = . ), with increasing levels observed up to h post-lps stimulation. il- production was evident from h and reached significance at h post-lps stimulation (p = . ). il- was significantly increased following stimulation of lg/ml lps for hr (p = . ) with lower concentrations of lps resulting in il- production at h (p = . ). release of il- was significant after h of lg/ml lps stimulation (p = . ), with lower concentrations of lps resulting in il- production at h (p = . ). in heparinized whole blood an lps concentration-dependent effect was evident for all cytokines. summary/conclusions: using a time-and concentration-approach our findings indicate that sheep are more tolerant and have a delayed response to lps stimulation compared to previous research using similar human in vitro whole blood culture models. in addition, data suggest that sheep have greater immune responses using heparin as anticoagulant for the collection of blood samples. improving our understanding of sheep immunology and development of relevant sheep transfusion models will provide a bridge between sheep models of transfusion and clinical settings. . rhdig inappropriately administered (unnecessary exposure) (n = , %) administered to: -rhd positive woman (n = ) -rhd negative mother with rhd negative neonate (n = ) -woman with immune anti d (n = ) -administered in error (instead of other ig) (n = ) rhdig delayed/omitted/wrong dose (risk of sensitisation to the d antigen) (n = , %) -omitted (n = ) -delayed (n = ) -inadequate dose (n = ) administration without correct patient identification (n = , %) storage & handling (n = , %) failure to check the maternal and neonatal blood groups prior to administration was identified as a source of error. misinterpretation of blood results also led to women receiving product inappropriately. e.g. reading a negative antibody screen as the mother being rhd negative. patient identification was raised as an issue. rhdig is often stored in satellite blood fridges for easy access. collection from these areas did not always require confirmation against patient identifiers and there was no register of women who received product or link to the batch number to ensure traceability. two incidents involved the administration of rhdig when the prescription for other immunoglobulin products was not clear, leading to a child and a baby receiving rhdig instead of the intended immunoglobulin. summary/conclusions: these incidents indicate problems with the processes of appropriate identification of women who need rhdig, the use and interpretation of pathology tests and requirements for prescription and administration. these resulted in omitted and inappropriate doses of rhdig. blood matters has made a number of recommendations regarding rhdig administration: -all health professionals involved in rhdig administration should be appropriately trained in the use of rhdig -confirmation of the maternal rhd status is essential prior to prescription or administration -positive patient identification must be used prior to administration of rhdig -health services should consider regular auditing to identify areas for improvement relating to rhdig blood matters continues to work with maternity care providers to improve practice. centro comunitario de sangre y tejidos de asturias, oviedo agencia gallega de sangre, organos y tejidos, galicia banco de sangre y tejidos de cantabria, cantabria banco de sangre de la rioja, la rioja banco de sangre y tejidos de navarra, navarra banco de sangre y tejidos de arag on, aragon fundaci on de hemoterapia y hemodonaci on de castilla y le on, castilla y leon fundaci on banco de sangre y tejidos de las islas baleares, islas baleares, spain terumo bct europe nv, zaventem, belgium background: hemovigilance, a long-term monitoring process made mandatory by national and supranational regulations, begins with a systematic whole blood or blood component collection and ends with an examining period after transfusion of blood components into the patients. in spain, organized in autonomous regions, the hemovigilance system is structured in three levels: ( ) the local level comprised of transfusion centers and hospital based transfusion services that monitor and collect all transfusion related adverse events (ae) and level them up to ( ) the regional hemovigilance coordinator, who communicates all the region's data to the ( ) spanish ministry of health which issues an annual report and corresponds with european institutions. to ensure safer blood supply, pathogen reduction technology (prt) was approved and implementation started in spain in . the mirasol prt system for platelets and plasma was introduced in and is currently being used in of the spanish regions. aims: to monitor the safety of the system, a passive hemovigilance study on mirasol treated products was initiated in the region of asturias and collaboration was extended to other regions (baleares, galicia, la rioja, cantabria, navarra, castilla y leon and aragon). methods: collected data included allergic and febrile reactions, trali and all other adverse event observed. severity of the event and level on imputability of the transfusion were also assessed using the who grading scale. hemovigilance data of mirasol treated products (platelets or m-pc and plasma or m-p) are included from to as blood centers started to apply the technology in routine. results: increase adoption of the mirasol system is observed between , when , mirasol treated blood products were issued to hospitals and with , mirasol products issued. due to low number of transfusions of mirasol-treated blood components in and , notification rates began to be analyzed in , showing ae rates of . %, similar to reports at the national level. stable transfusion reaction rates were observed with m-pc (around . ). rate of ae after transfusion of m-p is fluctuant between . and . . this fluctuation could be due to the inconsistent numbers of m-p transfused from one year to the other. most of transfusion reactions (around %) were of grade i severity and grade ii level of imputability. allergic reactions accounted for most of the adverse events, with g&i > reactions in and of respectively . and . no bacterial nor viral transfusion transmission was recorded on mirasol products during the study period ( ) ( ) ( ) ( ) ( ) ( ) . at the national level, nine cases of bacterial transfusion transmission (with g&i > ) were reported. these transmissions were probably due to transfusion of non-pathogen reduced products. summary/conclusions: the observed notification rate of ae is similar to the national rate but allergic reactions with g&i > is inferior with mirasol treated products. also, we found no reports of transfusion transmission infections nor cases of transfusion associated graft-vs-host disease, demonstrating safety of mirasol treated products. were attributed to human error ( %) with the lowest frequency in equipment failure ( %), compared to % and %, respectively, in the following three years. root cause analysis demonstrated failures in the quality management system including failures in administration, inadequate staffing for blood collection as well as in distribution and processing, and failures arising from institutional constraints and system failures in hospital management. high numbers of "other" aes ( %) in distribution and whole blood collection call for further investigation to indicate measures necessary for prevention and correction. errors related to incorrect blood component transfused (ibct) in - were in , , blood units ( / , ) issued for transfusion. these resulted in serious reactions ( %) ( fatal, life-threatening) . another ( %) were related with ibct that did not cause a reaction. near misses (component not transfused) were ( %) summary/conclusions: our data demonstrate increasing compliance with reporting requirements. questions about the initial factors for deviations in certain activities specifying failures in equipment and materials due to system as well as human errors, highlight the need for further specifications beyond "other" and "human error". background: the weakest link in the transfusion chain currently is the handling of blood components after their issue and the bedside blood administration practices. aims: to evaluate compliance with standard procedures for bedside blood transfusion practices by analysis of the "transfusion feedback forms" in a tertiary care multi-specialty hospital setting. methods: during the study period of months, the transfusion feedback forms received from various clinical areas of the hospital were studied with special reference to the transfusion times. the data was categorized based on the patient's location as well as the time of transfusion, whether done in routine or emergency hours. results: , blood components were issued during the study period, while transfusion feedback forms for , components ( . %) were received in the transfusion medicine department. delay in starting the transfusion (more than min after issue) was observed in transfusion events ( . %). the component transfusion time exceeded the permissible limits for component ( . %).the overall total permissible time for completion of components exceeded permissible limit in ( . %) of transfusion events. the pediatric ward ( . %), icu and ot complex ( . %) were found to be the most non-compliant delay in transfusion, transfusion time and total transfusion time. amongst the delayed transfusions after issue, ( . %) were during the routine hours i.e. between am to pm and ( . %) were in the non routine hours i.e. between pm to am. summary/conclusions: the audit of bedside blood transfusion practices has given us a good insight into various areas of noncompliances as well as the predominant locations in the hospital where the practices need to strengthened further. focused training program on safe blood administration practices for all staff involved in handling and transfusion of blood components is now planned to combat this issue. background: the international surveillance of transfusion adverse reactions (ars) and events (aes) (istare) of the international haemovigilance network (ihn) collects aggregate data from member national haemovigilance systems (hvs) in order to estimate the morbidity and mortality of blood transfusion in a holistic approach. the ultimate goal is to contribute to improving the safety of transfusion by close monitoring throughout the chain "from vein to vein". aims: we analyse recent istare data on suspected transfusion transmitted infections (sttis) for - in comparison to previous years of surveillance, [ ] [ ] [ ] [ ] [ ] [ ] [ ] methods: annual aggregate data from ihn member hvs on transfusion associated bacterial, viral and parasitic infections collected online in istare are analyzed by incidence in blood components (bcs) issued for transfusion, by severity and imputability as well as by blood component. ars with definite, probable or possible imputability were included in the analysis. trend analysis is performed to allow comparisons and to collect information on established and newly emerging infectious threats of blood transfusion. results: for - sets of annual aggregated data from countries covering , , bcs issued were analyzed. all ars totalled , and infectious ars amounted to ( . %). the overall incidence of the infectious ars was . / , units of bcs issued. bacterial infections were the most frequent ( , %), next viral ( , . %) and then parasitic ( , . %). serious were % and there were fatalities ( . %, incidence . / , ). nine deaths were attributed to sepsis and the other two were associated with non-malarial parasitic pathogens. one geotrichum clavatum fungal infection associated with apheresis platelets was reported as a free text comment. this very rarely recognized fungal pathogen caused a very severe infection in a patient but the route of transmission is inconclusive. the viral sttis included hbv ( %), hcv ( %) and hiv ( . %). the recorded as "other" ( . %) including cases of hev, one case of parvovirus b , one cmv and one ebv. no case of tt-malaria was reported. other stt-pi were (two fatal). the prevailing bcs were in general rbcs followed by platelets. comparison with corresponding data for - shows a consistent overall incidence in total sttis ( . vs . / , ). however, considerable differences were seen in separate categories, such as bacterial infections (significantly increased rate in - , p < . ) and an almost doubled rate of parasitic infections (p < . ). compared to the earlier period, there were many fewer hbv infections ( vs ) and many more hev. a similar reduction in the rate of hcv and hiv was observed in - in comparison with previous years. this may be explained by the fact that nat testing for hcv/hiv/hbv has been implemented in many countries in the last decade. summary/conclusions: the infectious risk of transfusion overall remains very low. the rate of bacterial cases has increased and among other viral sttis the frequency of hev is increasing. the mortality of transfusion due to sttis is lower than in the previous period of surveillance. abstract withdrawn. background: one of the main aspects of haemovigilance system in hospitals is following of adverse events and reactions related to blood transfusions. aims: it was intended to analyse the adverse reactions related to transfusion of blood components in pediatric patients. methods: over a four year period (january -december ), the haemovigilance records of all patients receiving blood transfusions procedures were reviewed and transfusion reactions were analysed. statistical analysis of data was performed by spss software (version . , spss inc., chicago, il, usa). majority of blood components were provided by regional blood center organized by national red crescent society. but granulocytes collected by apheresis after donor mobilization and reconstituted whole blood for exchange transfusions were prepared in the transfusion center of the hospital. results: the median age of patients who developed transfusion reactions was months (interquantile range-iqr ). the median for the numbers of individual transfusions in children in a year was (iqr ). the median for the numbers of blood components individually transfused to patients was (iqr ). patients, anaphylactic transfusion reactions in patients and transfusion-related lung injury (trali) in a patient. the overall incidence of transfusion reactions was estimated at a rate of . per units. summary/conclusions: it was reported that adverse effects related to blood transfusion, especially allergic reactions and fnhtrs are common in pediatric patients than adults. in a multinational study concerned about the transfusion reactions related with red cell concentrates, allergic transfusion reactions and fnhtrs were reported at a rate of and in units and in units, respectively. while the incidence of transfusion reactions in children was found . % in a study from the u.s.a., the overall incidence of transfusion reactions in our study which was estimated at a rate of . per units represents a lower rate. hospital gran canaria dr. negr ın, gran canaria hospital general universitario, ciudad real, spain hospital nostra senior de meritxell, andorra, andorra banco sangre y tejidos, santander banc de sang i teixits, barcelona, spain fundaci on hematol ogica colombia, bogot a, colombia centro regional de transfusi on de almer ıa, almeria complejo hospitalario de navarra, pamplona fundaci on banc de sang i teixits illes balears, palma de mallorca hospital de cabueñes, gij on, spain background: root analysis cause is defined as the cause of an error that, if it is treated, eliminates the repetition of the error aims: describe types of human and latent errors detected by a work group in the root analysis cause of transfusion incidents, analyze the concordance between the individual responses of the members and propose recommendations in order to improve transfusional safety. methods: in fifteen participants (nurses and hematologists dedicated to transfusion and component preparation) studied some incidents of administration of nonirradiated components and tried to approach the root causes by applying the classification of errors in mers-tm transfusion medicine. they transferred the answers to a questionnaire (simple or chain error, initial process affected, human and latent errors and measures derived from the analysis to correct the errors). the communication was made by mail and by the spanish transfusion society web forum, which contained the consultation documents. data and percentages are exposed for each type of error and the answers of the participants are tabulated. results: cases corresponded to patients. two patients of years of age diagnosed of acute myeloblastic leukemia (case and ) and chronic lymphatic leukemia (case ). in one case, the hematologist of the transfusion service canceled an irradiation prescription; in another, a patient with fever was transfused in the emergency room without the irradiation requirement and it was later discovered that he had received a transplant of hemopoietic progenitors month earlier; in the last case, neither the requesting doctor nor the laboratory technician nor the following doctor (prescriber) detected the alerts located in their respective computer applications. in all cases, the story was judged as sufficient for analysis. the majority of reviewers ( %) diagnosed a chain of errors. there was agreement of % with respect to the initial process affected. the initial error was communication ( %), monitoring ( %) and compliance ( %), in cases , , and . - human errors were detected per case (average: . , . and . errors respectively) and - latent errors per case (average: . , . and . , respectively). the latent errors most punctuated were: failures in the quality of the protocols ( %), in the transfer of important knowledge ( %), in the available technology ( %) and in the information to the patient ( %). all the participants contributed feasible measures of improvement according to root causes: ) improve the quality and drafting of work procedures and their compliance, including procedures of effective communication between professionals, ) train staff in knowledge important for safety, ) communicate with computer application providers to improve the effectiveness and visibility of the alerts and ) involve the patient with essential information to ensure transfusion safety. the measures were processed later as recommendations. summary/conclusions: the root analysis shows agreement between participants and allows the elaboration of useful recommendations to increase patient safety. this strategy can contribute to the comprehensive prevention of errors. background: in transfusion-associated circulatory overload (taco), pulmonary oedema develops primarily due to volume excess. data from the uk haemovigilance scheme, serious hazards of transfusion (shot) suggest that either the incidence of taco, or the recognition and reporting of taco, has increased over time. from to , reports of taco increased from to ; deaths from to , major morbidity from to . known risk factors include pre-existing cardiac and/or renal dysfunction, low body weight, extremes of age (eg, < years, > years), concomitant fluid administration, positive fluid balance, peripheral oedema and hypoalbuminemia. in a small subset of cases reported to shot, taco developed following transfusion for severe anaemia in the absence of other risk factors. this may be an under-recognised independent risk-factor. aims: to raise awareness of severe anaemia as an under-recognised risk factor for taco and is potentially life-threatening transfusion. methods: cases of taco submitted to shot over the last years were reviewed to identify cases where transfusion for severe anaemia was a key identifiable patient risk factor. results: the following are illustrative cases: -case : a patient in their s weighing kg was prescribed six units of red cells for iron deficiency anaemia after being admitted with hb g/l. the patient had no risk factors for taco except for profound anaemia. during transfusion of the fifth unit the patient became dyspnoeic, hypoxic and hypertensive. the patient recovered after diuretic therapy and had a post-transfusion hb level of g/l. -case : a patient in their s presented with a -week history of weakness and dizziness and had felt unwell for months. the hb was g/l, ferritin lg/l and ecg showed cardiac ischaemia. two units of red cells were transfused. after the second unit oxygen saturations fell despite supplemental oxygen, post-transfusion hb of g/l. a third unit was transfused over min and the hypoxia worsened with dyspnoea and crackles on chest auscultation. the chest x-ray showed an enlarged cardiac silhouette and pulmonary congestion. the patient improved with diuretics. -case : a patient in their s with severe megaloblastic anaemia, hb g/l and peripheral oedema developed taco after transfusion of units and recovered with diuretic therapy. summary/conclusions: chronic and acute anaemia are associated with compensatory cardiac changes irrespective of the aetiology of anaemia. this is further compounded by the underlying cause of anaemia particularly haematinic deficiencies (iron/b deficiency) that independently affect myocardial function. hyperdynamic circulation related to anaemia increases the load on the heart, causing myocardial ischaemia and hypoxia and if the anaemia is not corrected, eventually leads to heart failure. clinicians need to make an accurate diagnosis and avoid excessive transfusion in patients with severe anaemia with or without other additional risk factors. patients with chronic iron/folate/b deficiency without haemodynamic instability should be given the appropriate haematinic replacement. haematinic deficiency responds rapidly to appropriate vitamin/mineral. blood transfusions are to be given only when clinically indicated and even then, only the minimum volume needed for symptomatic relief transfused with consideration for diuretic therapy. methods: legal forms for reporting transfusion reactions were used in the retrospective analysis, which were adjusted by the department of quality assurance and quality control in the electronic form and distributed to clinics using blood components. clinicians were trained to report transfusion reactions through the hospital's transfusion board and through the "service for improvement of the quality and safety of health services" at the clinical center of sarajevo. analysis of the reported reactions in the institute include immunohematological and microbiological examination based on which the guidelines for further treatment with blood components are being made. users of registered services are obliged to report since . results: total of , different blood components were applied in the period between - . department for quality assurance and control has received serious adverse reactions, serious adverse event, reports of transfusion reactions, of which ( %) were inadequately filled, in the same period. from the above, ( . %) were transfusion reactions to erythrocyte blood components which were applied, ( . %) to platelet components and ( . %) were transfusion reactions after the application of fresh frozen plasma. the analysis has shown that the most frequent were febrile non-haemolysis reactions ( or . %), followed by allergic reactions ( or . %). two transfusion reactions ( . %) were characterized as circulation overload. summary/conclusions: the frequency of serious adverse reactions and events was . % ( of , ) and . % were reported transfusion reactions ( of , ). with the establishment of the hospital transfusion board and with the increase of collaboration with the clinical center, significant progress has been made. it is necessary to increase awareness among clinicians in regards to the safe transfusion practice. reporting transfusion reactions should be a mandatory procedure, a path to the proper selection of blood components, monitoring adverse reactions, and for us, transfusiologist, guide to the safest, most efficient blood components. j garc ıa-gala, e martinez-revuelta, a caro-g omez, c castañ on-fern andez and i fern andez-rodriguez hospital universitario central de asturias, oviedo, spain background: elderly patients are the main group of transfusion recipients in our country. given their comorbidities are a risk group for the development complications related to transfusion. aims: analyze the incidence of adverse effects related to transfusion in the elderly population and to assess what factors may influence its appearance methods: transfusions were reviewed in patients > years old. the variables analyzed were: sex, age, diagnosis/reason for transfusion, pre-transfusion hemoglobin (hb), number of transfused units, infusion rate and transfusion side effects, as well as the measures used to prevent or treat the transfusions. effects of circulatory overload results: a total of patients were analyzed ( women, men), with a median age of years ( - ). in total, ch were transfused. patients received ch, patients ch, patients received ch. patients were transfused at two different times. the median hb prior to transfusion was . g/dl. in the patients who received ch was . g/dl, those who received ch: g/dl and those who received ch: . g/dl. the infusion time could be estimated in % of the patients. in those who received ch was . min; . min in those who received ch and . min in those who received ch. patients ( % of the total) suffered some type of adverse effect related to the transfusion. in patients there was an increase in posterior ta, in an increase in hr, in an episode of hypotension and in another one episode of acute respiratory failure. % of those who had an adverse effect were older than years. patients with aht after transfusion, % received ch and the remainder ch. among their background, % had a history of ischemic heart disease. % also had a positive balance. the average previous bp was / mmhg and the subsequent one was / mmhg. % of patients did not receive diuretic treatment. in the case of the patient with acute respiratory failure was in oligoanuria, with positive balances. ch was transfused in total. she was treated with oxygen therapy and with intensification of the diuretic treatment, recovering later. summary/conclusions: -patients > years have a higher risk of suffering some type of adverse effect related to transfusion because they have pre-existing risk factors such as ischemic heart disease or heart failure. -we see that the risk of suffering some type of adverse effect in the elderly population is greater when we transfuse ch than ch. -we have appreciated that in those patients receiving ch, the infusion rate is higher. -the study highlights the lack of methods to prevent the development of circulatory overload. background: iron deficiency anemia is the commonest cause of anemia worldwide. weakness, fatigue, reduced physical activity and difficulty in concentration are the symptoms which are associated with its deficiency. the forefront treatment available is oral iron replacement therapy which is convenient, cost effective and has substantial outcome. another option is intravenous (i/v) iron when oral is not tolerable. despite of potential transfusion associated hazards and limited availability of blood due to shortage of voluntary blood donations, it is insisted by the patients prior to iron therapy. aims: the aim of conducting this study was to observe the impact of administration of oral iron, i/v iron and transfusion on hemoglobin levels in patients presented with iron deficiency anemia. methods: this was an observational study carried out at nibd and bmt, pechs campus, karachi, pakistan from february to december . the study was approved by the institutional review board. diagnosed ida patients presented at our hospital were recruited for analysis who were given oral iron, i/v iron and transfusion for the correction of anemia. informed consent was taken from the participants. descriptive and inferential statistics was applied by using spss version . . results: a total of ida patients were analyzed in which ( %) were females and ( %) were males. the most common symptom in females and males was fatigue followed by body aches in females ( %) and pallor in males ( %). menorrhagia was present in ( %) of females of reproductive age. surgical history was present in ( %) of females while there was no surgical history in males. mean hemoglobin, mch and mcv of females at baseline was . ae . , . ae . , and ae . while in males it was . ae . , ae . and . ae . respectively. sixty two ( %) females were advised oral and i/v iron and ( %) received transfusion. however, in males ( %) received transfusion and ( %) were advised oral and i/v iron therapy. it was observed that the increment of hemoglobin after oral/iv iron at average of months follow up in males and females was same as that the transfusion (p > . ). summary/conclusions: in our society where blood donations are scarce especially voluntary blood donations that are considered to be the safest type of blood donation. we would like to draw attention towards the alternatives to correct anemia such as oral and i/v iron replacement therapy as our results revealed that there was no difference in the increment of hemoglobin between the two groups. we need to educate our society especially the older age adults and young women who are more vulnerable of getting ida to opt oral and i/v iron therapy. it will be cost effective, convenient and also has less risk than transfusion. cellular therapies -stem cell and tissue banking, including cord blood background: the differentiation of megakaryocytes plays an important role in the production of platelets. however, the underlying mechanisms regulating megakaryocytes differentiation have rarely been studied. aims: to identify candidate genes involved in megakaryocytes differentiation and investigate the potential regulatory mechanisms of megakaryocytes differentiation from human cord blood hematopoietic stem cells in vitro. methods: cb-derived cd + cells were isolated using density gradient centrifugation and magnetic activated cell sorting (macs). cultures were stimulated with only recombinant human tpo ( ng/ml). after , and days, the mk fraction was selected by immunomagnetic sorting from the non-mk fraction using an anti-cd a monoclonal antibody. rna-seq-derived gene expression data was performed on uncultured samples (day ), cultured but unselected samples (day ), and cultured, selected samples (day , and ) by using the next-generation sequencing (ngs) platform, and rq-pcr technology was used to verify the expression of transcription factors. results: the comparison of the transcriptome profiles among the five stages showed that a massive gene expression change occurred in megakaryocytes differentiation. a total of genes were detected, of which showed up-regulation and down-regulation. among these genes, differentially expressed genes (degs) (fold change ≥ ; false discovery rate < . ) were selected were further validated with rq-pcr, including gabre, cdhr , wasf , pkhd l , thbs , pf v , lrrc and lgals . the rq-pcr result indicated that the mrna expression level increased with the prolongation of culture time. however, pf v mrna expression level was highest at day , lgals was highest at day . summary/conclusions: conclusion: our study identified a series of genes that may participate in the regulation of megakaryocytes differentiation. these results should serve as an important resource revealing the molecular basis of megakaryocytes differentiation and thrombocytopoiesis. preoperative anemia and blood transfusion requirement during hip and knee surgery rambam health care campus, haifa, israel background: blood transfusion (bt) is independently associated with increased morbidity, mortality and hospitalization length across different patient populations. due to bt-related risks, the concept of "patient blood management" (pbm) has been introduced to clinical practice. the three pbm pillars are: optimizing red cell mass, minimizing blood loss and optimizing physiological reserve. bt indications during orthopedic surgery include excessive bleeding or hemodynamic instability and not the hemoglobin (hb) level. in most clinical scenarios, a restrictive transfusion threshold (hb level: - g/dl) appears to be non-inferior to the liberal transfusion strategy in terms of blood use, morbidity and mortality. similar results are observed in highrisk patients after hip surgery. we hypothesize that preoperative anemia may lead to blood product overuse and its complications. aims: evaluating potential correlation between preoperative anemia and bt requirement during hip or knee surgery. methods: we reviewed medical files of patients who underwent hip or knee replacement surgery at rambam between - . patients with hb level measurement within days pre-surgery were included. receiving > blood unit was considered a surgery complication and such patients were excluded. patient demographic and clinical data, including comorbidities, surgery type, length of hospital stay, were collected. we created a synthetic data cohort using mdclone healthcare data sandbox, an environment enabling fast data extraction and producing synthetic data for analysis that does not require irb approval. results: during the evaluated period, patients underwent hip or knee surgery; were excluded from the analysis due to receiving > blood unit. hb measurement within days pre-surgery was available for patients. hip or knee surgery was performed in ( %) and ( %) patients, respectively. women comprised % (n = ) of patients who underwent hip surgery. in the hip-surgery group, . % of patients required bt, with this need being slightly higher among women ( . % vs. . %; p-value=ns). only ( %) patients were transfused during knee surgery and this cohort was not further analyzed. patients receiving bt had a significantly lower mean hb level than those who didn't require it ( . g/dl versus . g/dl for women and . g/dl vs. . g/dl for men; p-value < . ). hospitalization was longer in transfused patients compared to non-transfused ones (mean . vs. . days, p-value = . ) and in patients with a low hb level (female < , male < . ) than in those with a high hb level, irrespective of receiving bt (p-values < . ). patients with at least one of the following diagnoses: diabetes, renal failure, ischemic heart disease, were significantly more likely to have a lower preoperative hb level (p-value < . ). no other factors (e.g., patient's weight, rdw value or blood pressure) were predictive of transfusion need. the probability of a need for blood unit was . in the hb g/dl group and . in hb g/ dl group ( %>reduction). summary/conclusions: anemia presence before elective hip surgery is a risk factor for bt requirement and longer hospitalization. diagnosis and management of anemia using timely pre-surgery consultations may minimize intraoperative bt, particularly in women and patients with comorbidities. real-patient data and prospective trials are warranted. abstract withdrawn. abstract withdrawn. background: cd , known as platelet glycoprotein iv, belongs to type b scavenger receptor and is related to the pathogenesis of many diseases. type i cd deficiency was cd not expressed on platelets and monocytes. individuals with type i deficiency can produce homologous antibodies and cause related immune diseases. in recent years, it has been reported that cd deficient individuals cause fetal immune thrombocytopenia with fetal edema syndrome in asia. cd is not expressed in mature rbc, but exists in hematopoietic stem (progenitor) cells. anemia is an important cause of edema. in view of the phenomena of clinical and animal experiments, cd + hematopoietic stem (progenitor) cells were cultured in vitro to observe the effect of anti-cd monoclonal antibody on cd + hematopoietic stem (progenitor) cells. aims: to investigate the effect of anti-cd monoclonal antibody on proliferation and differentiation of human cd + hematopoietic stem (progenitor) cells in vitro. methods: choose healthy full-term maternal women without various obstetric complications, take cord blood ml. after density gradient centrifugation of ficoll cell separation solution, cd + hematopoietic stem (progenitor) cells were sorted by flow cytometry and cultured for - generations. mtt was used to examine the effect of anti-cd monoclonal antibody on the growth of hematopoietic stem (progenitor) cells. flow cytometry analysis was used to detect the apoptosis and cell cycle of cd + hematopoietic stem (progenitor) cells. the effect of anti-cd monoclonal antibody on the formation of cfu-e/bfu-e in hematopoietic stem (progenitor) cells was analysis by cfu-e/bfu-e account after - days culture. results: after umbilical cord blood was isolated by ficoll to obtain mononuclear cells, the hematopoietic stem (progenitor) cells of cd + were sorted by flow cytometry, and about . % of cd + hematopoietic stem (progenitor) cells were isolated. different concentrations of anti-cd monoclonal antibody and hematopoietic stem (progenitor) cells were cultured in vitro. the od value of value ( . ae . ) of anti-cd monoclonal antibody group ( mg/ml) was decreased than normal group ( . ae . ) (p < . ), and the od value ( . ae . ) was significantly decreased at the cd monoclonal antibody concentration of mg/ml (p < . ). there was no significant difference between the hematopoietic stem (progenitor) cells culture group and the igg control group (p > . ). in the annexin v flow detection, the apoptotic rate of anti-cd monoclonal antibody group ( mg/ml) was statistically increased than the normal group (p < . ). anti-cd monoclonal antibody significantly induced hematopoietic stem (progenitor) cells to undergo s phase cell reduction, g phase cells increased, and g /s phase cell arrest occurred. the number of cfu-e/bfu-e clones in the normal group was ae , the number of cfu-e/bfu-e clones in the control group was ae , and the number of cfu-e/bfu-e clones in the anti-cd monoclonal antibody culture group was ae . the number of colonies formed by hematopoietic stem (progenitor) cells in the anti-cd monoclonal antibody culture group was significantly lower than that of the other groups (p < . ). summary/conclusions: anti-cd monoclonal antibody can reduce the proliferation of human cd + hematopoietic stem (progenitor) cells and reduce the ability of erythroid differentiation. background: recently the new modern collection techniques were introduced in the apheresis procedures. cobe spectra system was replaced with spectra optia, and it was necessary to verify the efficiency of spectra optia in pbpc collections. aims: the aim of the study was to evaluate and optimize the new cmnc protocol spectra optia v. (terumo) for pbpc collections in patients with haemato-oncological malignant diseases. methods: the results of autologous pbpc collections were evaluated in: (a) well mobilized patients with precollection cd + cells concentration in blood higher than /ll, (b) from only the first collections, which were performed either by the use cmnc spectra optia v. or cobe spectra v. , v. , terumo (c) collections were performed in the standard and large volume leukapheresis regimen, lvl. engraftment data in transplanted patients were assessed. results: standard collections were performed in patients. the yield of cd + cells was high, and no significant differences were found between the numbers of cd + cells prepared from spectra optia , ( , - ) and cobe spectra , ( , ) /kg b. w. (a = , ; pval , ). the dependence of cd + cell yield on the precollection concentration of cd + cells in blood can be considered as linear with high correlation coefficients in cmnc spectra optia r = , , and cobe spectra r = , . lvl collections were performed in of patients, and there were no significant differences between the numbers of cd + cells prepared by cmnc spectra optia , ( - , ) and cobe spectra , ( , - ) /kg b.w. (a = , ; pval , ). the relations between the precollection cd + cells concentration in blood and the numbers of cd + cells from collections can also be considered as linear with the correlation coefficients in cmnc spectra optia r = , , and cobe spectra r = , , respectively. in lvl, the median platelet loss was significantly lower in cmnc spectra optia ( %) than in cobe spectra ( %). a group of patients was transplanted by means of pbpc prepared in the standard regimen. median time in the neutrophil reconstitution was in cmnc spectra optia as well as cobe spectra days, while in platelets from cmnc days, and from cobe spectra days, respectively. the number of patients obtained pbpc from lvl. the median time in neutrophils and platelets reconstitution was in cmnc spectra optia as well as cobe spectra the same, and corresponded with and days, respectively. summary/conclusions: cmnc protocol spectra optia is a modern, efficient and the safe system, which can be used for both standard and lvl procedures. in well mobilized patients the sufficient dose of cd + cells for transplantation could be prepared from one standard or one lvl procedure. no serious adverse reaction have been observed. background: peripheral hematopoietic stem cells are collected from patients/donors after mobilization with g-scf. the aim of the collection is a fixed number of cd + cells/kg. this number depends on the pre-apheresis cd + number, the blood processed and the collection efficiency of the procedure. the aim should be to collect all the requested cells in day, whenever possible. this is in order to reduce the dose of g-csf given to donor/patient and the resources used in the collection centre. the only parameter that can be adjusted is the volume of blood processed, if this is increased, the likelihood of collecting the requested amount of cells is increased, but only if the pre-apheresis cd number is high enough. therefore, you need to know, when it is feasible to increase the volume and thereby increasing the time of the procedure with the intention to collect all the requested cells in day. it can also show if it is possible to reduce the volume of blood processed, thereby reducing the time of the procedure. aims: to develop an easy tool to calculate the volume of blood processed in order to collect the requested cells in day. methods: the mean collection efficiency (ce) was calculated. ce is calculated as cd + cells collected/(pre-apheresis cd + number*processed volume)* %. based on the mean ce, an excel sheet was generated to calculate the volume of blood that should be processed in order to collect all the requested cells. the excel sheet is designed so the user enters the pre-apheresis cd + number, patient weight and the requested number of cd + cells. the ce is fixed according to the mean ce calculated. the result is the volume of blood processed in order to collect the requested yield. based on that result, the apheresis machine will provide time for the procedure, thereby it is possible to evaluate if the collection can be finished in day or not, e.g. by increasing the volume of blood processed. spectra optia â was used for all collections, cmnc for allogeneic donors and mnc for autologous patients. results: mean ce = % (n = ). a ce of % was chosen as the cut-off for the cd calculation tool. using the cd calculation tool: allogeneic donors (n = ): mean ce = %, mean blood volume processed = . tbv, mean time: min, donors were finished in day collection ( %) autologous patients (n = ): mean ce = %, mean blood volume processed = . tbv, mean time = min, patients were finished in day ( %). the calculation failed in only case ( . %). in this case the volume of blood processed was reduced according to the calculation, but because of unexpected low ce, the requested number of cells was not achieved. summary/conclusions: the cd calculation tool based on an excel sheet has shown to be simple and easy to use in order to personalize the stem cell collection. immunotherapy products: blood product, pharmaceutical, or a new category all together? from till . all donors were hla typed and matched; they were fully informed on the donation procedure and signed an informed consent for donation. minimum dose required to ensure successful and sustained engraftment was /kg cd + cells and /kg mono-nucleated cells (mnc). pbsc harvesting was performed with continuous flow cell separator baxter c , cobe spectra and spectra optia using conventional-volume apheresis processing the - . total blood volumes per apheresis. a femoral catheter was used for harvesting and acid citrate dextrose formula a is used for anticoagulation. recombinant human granulocyte colony-stimulating factor (g-csf) is used to mobilize pbpc for collection. harvesting of pbsc is usually performed after to days of g-csf subcutaneous administration at a dose of lg/kg body weight. results: all the donors were siblings of the patients treated at the university hematology hospital. there were apheresis procedures performed in healthy sibling donors. there were males and females, aged - . one to two apheresis procedures were required to collect adequate graft. the single procedure usually took - h and the volume of collected stem cells was - ml. the needed number of mnc and cd + cells was successfully collected by . apheresis. there were abo incompatible donors. procedures for mobilization and collection of pbpc from healthy donors are generally well tolerated. the only adverse effects of the apheresis procedure were bone pain as reaction of g-csf and numbness of the extremities as reaction of acd-a (hypocalcemia), which occur rarely and were very mild. the collected pbsc were used in allogeneic stem cell transplantation in patients with: acute myeloid leukemia - patients ( . %), acute lymphoblastic leukemia - patients ( . %), chronic myeloid leukemia - patients ( . %), myeloproliferative disorders - patients ( . %), myelofibrosis - patients ( . %), severe aplastic anemia - patient ( . %), non-hodgkin lymphoma - patient ( . %), multiple myeloma - patient ( . %), chronic lymphoblastic leukemia - patients ( . ), hodgkin disease - patient ( . %). summary/conclusions: the apheresis collection of pbsc in healthy donors is an effective and safe procedure. we are developing our national stem cell donors registry as a part of bone marrow donors worldwide. in that way we hope we will help widen the world network of stem cell donors and enlarge the possibility for each patient to find the right match. background: leukocyte-removing filters for blood are being used widely as a universal leukocyte reduction policy is being adopted progressively throughout the world. filtration is one of the most effective methods for preventing various adverse transfusion effects caused by leukocytes included in blood components, such as febrile reaction, alloimmunization, and transmission of leukotropic viruses. aims: the goal was to evaluate whether the new domestic blood filter finecell, developed by kolon industries, gumi, korea, is appropriately suited to the international standards. and to reveal its efficacy and safety in the settlement of leukocyte reduction system in korea. methods: thirty-two units of packed red blood cells obtained from ml whole blood collected from healthy donors were used. this was done by analyzing the filtration time, residual leukocyte count, rbc recovery, and hemolysis rate during a storage period of days after leukoreduction. results: the standards commonly used for the evaluation of leukocyte-removing filters are set by the food and drug administration of the usa and the council of europe. the results of our study satisfied these international standards. summary/conclusions: the newly developed domestic leukoreduction filter was, thus, found to be efficient and will contribute to the improvement of the quality of isolated blood components used in korea. faculty of science, humanities and education, technical university of liberec, liberec, czech republic background: as polymeric fibrous scaffold fabrication techniques strive to create structures that more closely replicate tentative extracellular matrix form and function, the need for increased scaffold bioactivity becomes more pronounced. the fibrous structure made from biocompatible and nontoxic polymers ensures mechanical stability, however cell proliferation requires further stimulation. platelet-rich plasma, which has been shown to contain over bioactive molecules, has the potential to deliver a combination of growth factors (gfs) and cytokines capable of stimulating cellular activity. aims: the presented work deals with the preparation of nanofibrous materials with platelet growth factors incorporated into the internal fiber structure. polyvinyl alcohol (pva) was used for the preparation a material providing a progressive release of native gfs without need of subsequent crosslinking. methods: materials were prepared from pva (mw , , % of hydrolysis) using electrospinning technology (nanospider tm ws u). platelet lysate (pl) was prepared from thrombocyte rich solution (obtained from regional hospital in liberec, the concentration of - x plt/ml, freeze-thaw method with subsequent centrifugation). nanofibers were electrospun from % pva solution using water: ethanol ( : ) solvent system. materials with proteins were electrospun from solution containing % of pva and % of pl. morphological analysis was performed by scanning electron microscopy. protein release was monitored using spectrophotometry (bradford method) and chromatography. results: the prepared fibrous materials consisted of random oriented end-less fiber with smooth surface with minimal defects in structure. the morphology of materials was not altered by the addition of proteins. the average fiber diameter was: ae nm for pristine pva fibers and ae nm for pva with incorporated proteins (pva/pl). pva/pl layers contain - mg of protein per gram of pva. % of the proteins are released during the first day (burst release) followed by a gradual release of up to weeks. summary/conclusions: nanofibrous pva-based nanofiber materials were prepared with native growth factors. the process used for the preparation of solutions and subsequent spinning does not affect the activity of the incorporated proteins, which are being gradually released. therefore, we believe that the developed material has great potential for use in tissue engineering e.g. to promote healing of chronic wounds. acknowledgements: supported by the czech health research council, project no nv - - . background: human a-defensins are small cationic peptides with antimicrobial and anticancer activity. up till now, six a-defensins have been described in humans. they include the human neutrophil peptides (hnp) , and which present in large amounts in neutrophil azurophilic granules and differed from each other only in the first amino acid. a fourth defensin, termed hnp- , comprises less than % of the total defensins in neutrophils and has a distinct sequence from hnp - . the other two, human defensin and , are synthesized mostly by intestinal paneth cells. neutrophil defensins (hnp - ) are . kda peptides that are characterized by three disulfide bridges. the pattern of disulfide bonds in the mature forms is crucial for the functional properties. due to this structural feature, synthesis of defensins using the chemical and recombinant approach presents quite a challenge. moreover, purification from the natural source can be very difficult because the large number of neutrophils is needed to obtain a sufficient amount of protein. in blood banks, leukocyte reduction filters are used to remove leukocytes from blood components in order to prevent adverse transfusion reactions. leukofilters contain high numbers of normal human cells and discard after use. aims: the aim of this study was to purify a-defensins from neutrophils trapped in leukocyte reduction filters. methods: blood bags from healthy blood donors were collected after written consent. all donors were screened for infectious diseases (hbv, hcv and hiv) and negative samples were included in the study. blood bags were filtered at °c by leukoflex lst- filters. the cells were extracted from the filters by back-flushing with cold phosphate buffered saline (pbs), ph . , without mgcl and cacl , containing mm edta and . % sucrose. the pbs was homogenized with the filter content and then collected in a sterile tube. neutrophils were separated from mononuclear cells by ficoll. isolated neutrophils resuspended in pbs x at a concentration of cells/ml. for degranulation, cells were stimulated with nm of formylmethionyl-leucyl-phenylalanine (fmlp) for min followed by stimulation with lm of cytochalasin b for min. supernatant was collected by centrifugation at g for min. supernatant was incubated with mouse monoclonal antibody to hnp - and purification of hnp - was performed by lmacs protein g microbeads system. the presence of protein was confirmed by western blot. results: the presence of the . kda band was confirmed by western blot, which corresponded to the size of the a-defensins. summary/conclusions: the development of defensins as therapeutic products requires access to a steady supply of neutrophils. our results indicated that lst- filters are economical source for purifying a-defensins. anatomical sciences, abadan school of medical sciences, abadan, iran background: epigenetic reprogramming of terminally differentiated cell can modify somatic cells to a pluripotential state. there are several approaches that induce pluripotency in somatic cells. exposure the cells with the embryonic stem cell extract is an easy way, and some investigations were done on fibroblast cell line. however, its efficiency was low aims: the purpose of this study was to increase the number of reprogrammed granulosa cell as a full differentiated cell into pluripotential state methods: the human granulosa cells were cultured in the medium containing -aza-deoxycytidine and trichostatin a. then, the cells were exposed to mouse escs extract and co-cultured with mouse embryonic fibroblast in the presence of leukemia inhibitory factor (lif). alkaline phosphatase test and also immunohistochemistry staining for oct , sox and nanog were performed after and h and week results: the results indicated that after h the granulosa cells were revealed a round and expanded morphology. the cells in all groups except in negative control, were showed alkaline phosphatase activity. the cells that were cultured in medium containing -aza-deoxycytidine and trichostatin a and exposed to the extract had the most numbers of alkaline phosphatase positive cells. immunocytochemistry showed the granulosa cells that were cultured in medium containing -aza-deoxycytidine and trichostatin a with extract expressed oct with weak intensity after h. no expression of oct , sox and nanog were observed in other groups at the same time. after h, oct , sox and nanog were over expressed in the cells that were treated with -aza-deoxycytidine, trichostatin a and extract. furthermore, there was high expression of oct in the granulosa cells that were cultured in medium containing dmso and exposed to the extract. after one week, the expression of oct and sox in the granulosa cells that were cultured in medium containing dmso and exposed to the extract was continued while its expression ceased in the other groups. the expression of nanog were ceased in all groups after one week summary/conclusions: present study revealed that the inhibitors of the methyl transferase ( -aza-deoxycytidine) and histone deacetylase (trichostatin a) could delete the epigenetic markers and improved cells reprogramming by administration of the extract abstract withdrawn. abstract withdrawn. abstract withdrawn. background: mesenchymal stem cells (mscs) are adherent spindle shape cells expressing different surface markers. they show special criteria including, paracrine effects, differentiation to several tissue cells, migration, immunomodulatory and regenerative potentialities. mscs are isolated from different sources and employed as therapeutic tools to treat several diseases and injuries. however, some of mscs properties including secretion of growth factors and migration ability are controversial especially during remission or in presence of tumor. interestingly, msc-derived compartment could be used as practical tools in term of diagnosis, follow up, management and monitoring of disease instead of intact mscs. exosomes are kind of extracellular vesicles (evs) characterized via their size and releasing mechanism. usually they defined as less than nm in diameter vesicles. they secreted from different cells and are also found in urine, blood, breast milk, cerebrospinal fluid and other body fluids. exosomes contain genetic material including dna, mrnas, micrornas (mirnas) and other biomolecules. mirnas are single stranded non-coding rnas transcribed from dna. immature mirnas are subjected to two known cleavages to modify to mature mirna that involve to either mrna degradation and gene expression process or cell-cell interaction and communication via secretion as the part of exosomes. aims: this study was aimed to discuss some aspects of exosomal micrornas derived from mscs in progression, diagnosis and treatment of some diseases. methods: different scientific data bases including pubmed, google scholar and scopus were used to find and review related articles. results: evs play important role either in intercellular communication related to pathological and physiological situation or intracellular communication, angiogenesis, immune system modulation and metastasis progression. mirnas could regulate expression of multiple mrnas then they play important role in different biological processes and contribute cell-cell interaction as well as influence in the progression of different disease. exosomal mirna-derived mscs are involved in cancer procession, tumor growth, angiogenesis and metastasis. they are used as diagnosis and therapeutic tools to treat different diseases such as renal failure, liver fibrosis, myocardial infarction. summary/conclusions: due to controversial aspect of using of intact mscs especially during remission or in presence of tumor, msc-derived exosome could be used as practical tools in term of diagnosis, follow up, management and monitoring of disease instead of intact mscs. aims: the aim of study try to use sybr green i based real-time pcr to identify homozygous, heterozygous, gene deletion or wild type for rhd exon , , and a. methods: for this study, we used real-time pcr with high resolution melting curve mode, and matrix mix containing sybr-green i were used for sequence specific primers of g>a and rhd exon , , . samples with rhd gene deletion homozygous/heterozygous, g>a heterozygous with rhd gene deletion and normal rhd, normal rhd homozygous/heterozygous and rhd -rhce( - )-rhd homozygous/heterozygous were enrolled in our study. all samples were screened using rhd exon genotyping, sanger sequencing and rhesus box analysis. concentration and mass of dna samples were in alleles of normal rhd/rhd gene deletion. the tm ratio of rhd exon ( °c) to internal control ( °c) were . in alleles of normal rhd/rhd -rhce( - )-rhd , . - . in alleles of rhd gene deletion/normal rhd, . - . in alleles of normal rhd and < . alleles of rhd gene deletion. the tm ratio of rhd exon ( °c) to internal control ( °c) were . in alleles of normal rhd/rhd -rhce( - )-rhd , . - . in alleles of rhd gene deletion/normal rhd, . - . in alleles of normal rhd and < . alleles of rhd gene deletion. the tm ratio of rhd exon ( °c) to internal control ( °c) were . in alleles of normal rhd/rhd -rhce( - )-rhd , . in alleles of rhd gene deletion/rhd -rhce( - )-rhd . - . in alleles of rhd gene deletion/normal rhd, . - . in alleles of normal rhd and < . alleles of rhd gene deletion. summary/conclusions: using the tm ratio of sequence specific primers to internal control is an effective way to detect the rhd gene deletion or rhd weak d types , and not detected") were tested with a method based on next generation sequencing (ngs) using the illumina miseq platform to detect a possible rhd variant not interrogated by id rhd xt. results: in total dna samples were tested in pools. fifteen ( ) pools ( samples) gave rhd deletion genotype and seventy two ( ) pools ( samples) resulted to the presence of rhd gene. the positive pools were also analyzed individually. the genotype results obtained were: rhd exon no amplification ( ), rhd exon and the genotype results obtained with id rhd xt (in pools and individually) were concordant with the results provided by the centers. hence, % accuracy was obtained using id rhd xt with dna pooled samples. the results of rh ngs for the samples with inconclusive results by id rhd xt showed rhd variants previously described: sample rhd* - inst (del), sample rhd*ivs + g (del), samples rhd*weak d type (partial d), sample rhd*weak d type (weak d), sample rhd*weak d type (weak d) and not described: sample rhd*del - (unknown) summary/conclusions: id rhd xt is a high accurate tool for genotyping the most common rhd alleles associated to weak d and d negative phenotype in up to pooled dna samples. use of rhd genotyping improve rhd typing in blood donations variant rhd alleles generate qualitative/quantitative alteration in serological expression of d antigen such as weak and partial rhd phenotypes which are clinically important in transfusion setting. population studies have shown varied distribution of the variant d alleles in caucasians, africans, east asians and indians. many countries have developed their own population-specific strategy for identifying d variants. our previous study in indian population showed absence of weak d type , , and which are commonly found in caucasians d variant individuals. instead, a novel population-specific pattern i.e.~ -kilobase duplication event, including exon , was predominantly identified in . % d variant samples. functional analyses showed that this genetic variation results in the expression of several transcripts, including a wild-type product. commercial genotyping assays available, mainly detect common d variants found in caucasians and africans, thus limiting its usefulness in india. hence, based on our findings we have designed a multiplex pcr assay specific for indian population that can be easily implemented at the laboratory level for genotyping variant rhd. aims: to characterize rhd variants using "indian-specific, rhd genotyping assay". methods: seventy samples referred to our laboratory for molecular characterization of rhd variants were included in this study. all rhd variant samples were serologically typed for results: out of the rhd variants included in this study, samples ( %) showed presence of indian specific allele i.e. exon duplication. seventeen rhd variants samples showed presence of both exon and . qmpsf analysis of these samples excluded involvement of rhd-rhce-rhd hybrids. sixty of the seventy d variant individual had r r genotype this assay thus can be used routinely in indian laboratories to identify and characterize rhd variants. - non-invasive fetal kel genotypes from allo-immunized anti-kel women were done ( positive confirmed fetuses, undetermined, positive non-confirmed, negative non-confirmed and negative confirmed). - non-invasive fetal rhc genotypes from allo-immunized anti-rh women were done non-invasive fetal rhe genotypes from allo-immunized anti-rh women were done ( positive foetuses, undetermined for , % of the allo-immunized women, the pregnancy was compatible and no specific antenatal monitoring was necessary summary/conclusions: non-invasive fetal red blood cell genotype is a powerful tool to diagnose a feto-maternal red blood cells incompatibility and allows to legitimize a costly and heavy specific antenatal monitoring s purchla-szepioła , m krzemienowska , m pelc-kłopotowska , m jurkowska , m debska , m uhrynowska and e brojer the test developed by ihtm has been offered to clinicians and pregnant women since but it is not covered by the health care system. rhd nipt is not informative for mothers with rhd variant. in such cases further analysis of the molecular background is offered to exclude from immunoprophylaxis the women with weak rhd type , and . aims: summary of a -year period of routine rhd nipt available at ihtm. methods: cffdna isolated using easymag, biomerieux from plasma of pregnant women determined with standard serology as rhd-negative (in - week of gestation) was examined for the presence of exons and of rhd and ccr by realtime pcr using lc ii (roche). maternal dna from whole blood was tested for identification of rhd variant using rbc fluogene rbc-dweak/variant (inno-train, germany) or the home-made protocol. results: in cases the rhd gene was not detected in cffdna and the administration of rhig was not recommended. in seven cases ct-values for rhd and ccr indicated a maternal d variant (d ct ccr -rhd > ); the genetic follow-up of six of them identified: rhd* w. in cases, rhd* w. and rhd* . in cases the rhd nipd results indicated that a fetus is rhd positive and rhig administration was recommended it was recommended in the remaining % of mothers. in . % cases with maternal d variant rhd nipt was not possible. however, in / such cases the test is unnecessary because follow up analysis revealed maternal rhd variant of the weak d type and in switzerland extended antigen-matching for duffy, kidd and mnsbesides rhesus and kell -is recommended for sickle cell disease (scd) patients. the ethnic diversity of red blood cell (rbc) antigen polymorphism engender that these patients are often transfused with rbcs from donors of african origin. this strategy, however, increases the likelihood of being exposed to certain low-prevalence antigens, such as rh (d w ), as these are almost exclusive to african populations. rh is encoded by several types of rhd*dv as well as by dau- . anti-rh is associated with delayed hemolytic transfusion reactions (htr) aims: here we report a specific low-prevalence antibody newly formed by the same patient, meanwhile gravida , para , causing positive crossmatches with the rbcs of two of the four selected donors. subsequently, advanced serologic and genetic workup and close international collaboration enabled optimal patient care. methods: standard serological methods were used for antibody specification (biorad, cressier, ch and in-house). crossmatches were carried out by indirect antiglobulin test at °c. molecular typing of donors' and parental blood group antigens was performed by further serological analysis (institute national de transfusion sanguine, paris) revealed an anti-rh in addition to anti-fy , anti-e and anti-jk a . genotyping of the two donors causing positive crossmatches presented heterozygosity for rhd* . which encodes rh . the newborn's phenotype was a r r k-, fy(a-b+) and most likely rh -and jk (a+b+), considering both maternal and paternal (a r r, k-k+, fy(a-b+), jk(a+b-), rh -) predicted phenotypes. the neonatal serum contained maternal anti-a , anti-rh and anti-e. the direct antiglobulin test was positive but elution only showed nonspecific reactions with papain-treated cells. latter might have been caused by anti-fy during her present pregnancy we were able to demonstrate that two positive crossmatches of two former compatible donors were caused by a new alloantibody against a low-prevalence antigen, namely anti-rh , derived from several rh + rbc transfusions during the previous pregnancy. despite this challenging blood supply we were able to support the patient with a total of ten antigen compatible and crossmatch negative rbc units from french and swiss donors until delivery with increasing age, the relative number of women in the study population raise from % in the patients younger than years to % in the patients older than years. our study showed that cardiovascular diseases were the commonest indications for warfarin use in older patients with %. only , % achieved target therapeutic range while the risk of thromboembolism and the subsequent need for proper anticoagulant therapy increases sharply with age, the bleeding risk rises as well. older patients are more sensitive to any given dose of warfarin and need a significantly lower total weekly dose. a well-informed patient provides one of the best defenses against bleeding complications. recent data demonstrate doacs advantages over warfarin, especially for older population: more predictable dosing, fewer drug interactions and reduced risk of intracranial bleeding although vast majority of fh cases are caused by mutations in ldl-r gene %- % patients do not harbor genetic cause in the known loci. patients with homozygous/severe heterozygous fh are unresponsive (ldlc above mg/dl with diet and drug therapy) and require additional extracorporeal therapy to reduce ldlc concentrations to prevent the development/progression of cad. ldl apheresis techniques remove apolipoprotein b-containing lipoproteins from blood and include heparin-induced extracorporeal ldl precipitation(help), immunoadsorption, dextran-sulfate adsorption methods: a y iraqi male visited cardiac-opd. ct coronary angiogram showed cad-dvd. he had multiple tendinous xanthomas and xanthelasmas. family history was significant for death of elder brother from coronary event at y, a sister with similar profile age y and one sister apparently normal. he was taking medical treatment for dyslipoproteinemia (ecosprin mg od, ticagrelor mg bd, rosuvastatin mg od). despite dietary and medical treatment his dyslipoproteinemia was refractory. therefore cascade-filtration was planned with evaflux a plasma fractionator. one procedure of cascade plasmapheresis was done on com.tec apheresis system (fresenius kabi, germany) separating patient's plasma as the first step and passing it through a pore sized based filter column a (evaflux, kawasumi, japan) as the second step. a total of . x plasma volume( ml) was processed. the patient was given continuous calcium infusion. the flow rate of ml/min was maintained immunoglobulins) were not assessed. summary/conclusions: the procedure successfully met the requirement of reduction of cholesterol by %. the patient became responsive to the medical treatment. follow up of the patient up to a year has been uneventful with no additional procedure requirement actions included development of major haemorrhage protocols with improved communication and required instances of delayed transfusion to be reported to the uk national haemovigilance scheme (serious hazards of transfusion, shot) methods: delayed transfusion data have been collected from . hospitals identify incidents and report them via an online database. mh may also result in avoidable or overtransfusion. reports are analysed and collated data published in the shot annual reports in july each year. results: the total number of reports of delayed transfusion has increased with time: , , in the last years. delayed transfusion in relation to mh was reported for cases - contributing to death in patients %) miscommunication was noted between clinical different teams, between emergency departments, porters and the transfusion laboratory, failure of bleeps, failure to communicate the urgency, failure to confirm the patient location. failures to follow mhp correctly occurred in / ( . %): incorrect activation including failed alerts to porters, wrong contact telephone details and wrong components in the mhp packs most transfusions included red blood cells (median, units); % of women were transfused with fresh frozen plasma (median, units) and % with platelets. mean pre-and post-transfusion hemoglobin levels were . g/dl and . g/dl, respectively, representing an increment of . g/dl per rbc unit transfused ( . g/dl in soweto and . g/dl in durban). indications for transfusion included obstetric hemorrhage ( %), chronic anemia ( %), surgery or anesthesia ( %), other ( %) and not specified ( %). transfusion for chronic anemia (vs. hemorrhage) was associated with gestation ≥ weeks (odds ratio = . , % confidence interval . - . ). surgical blood loss was a common indication in trimester ( %) that declined to % then % in trimesters and . summary/conclusions: hemorrhagic complications accompanying spontaneous abortions and ectopic pregnancies in the first and second trimesters were the most common reasons for antenatal transfusion surveillance and analysis of blood transfusion reactions represents inseparable part of hemovigilance. aims: summarization of data on reported cases of transfusion reactions. methods: analysis of serious undesirable reactions to blood products administration in the czech republic (cr) during period - . results: there were evaluated , of blood products administrations in , patients in the cr during defined three years period. announced , ( , %) transfusion reactions including severe transfusion reactions ( adjudged with grade ). the most frequent types of severe transfusion reactions: anaphylaxis , trali x, taco x, hcv x, hbc x, bacterial infection x, delayed hemolysis x. transfusion reactions incidence according to administered bp: red blood cells products: , administrations, transfusion reactions (fnhtr x, allergy x, circulatory overload x, anaphylaxis x, trali x, hbv x, hcv x) platelets: , thrombocyte administrations, including transfusion reactions (allergy x, fnhtr x, anaphylaxis x, circulatory overload x, delayed immune hemolysis x, acute circulatory overload x. granulocytes: administrations, transfusion reactions plasma: , administrations, reactions reported (allergy , fnhr , circulatory overload , anaphylaxis x, trali x, hbv x, ards x. summary/conclusions: conclusions: comprehensive analysis and data processing help to appropriate prospective setting of blood products (bp) production and hemotherapy. concrete outputs from processed data triggered undermentioned changes in many departments in the cr: . plasma for clinical uses from male blood donors, . prestorage of leucocyte reduced blood products, . production of platelets in additive solutions, . implementation of pcr testing method for blood donors screening. background: skae's basic activities include epidemiological surveillance of all adverse events (aes) associated with deviations in the collecting, testing, processing, storage and distribution of blood and blood components that may affect quality and safety near misses" and "uneventful transfusion errors" are collected to identify preventable causes. incorrect blood component transfused (ibct) events are reported following ihn instructions. results: a total of they were mainly associated with deviation in processing ( . %) and attributed to equipment failure and materials ( %) whole blood collection, materials and distribution, as a result of product defect, equipment failure, human error and other. trend analysis showed a significantly increasing (p < . ) annual rate of total aes by % ( % confidence interval - ) ) % fibrinogen-depleted phpl or ( ) % fibrinogen-depleted phpl plus heparin. internalization of fluoresceinamine-labeled heparin in stcs was investigated by flow cytometry and immunocytochemistry. all stromal cells were subjected to whole genome expression analysis (affymetrix human gene . st array) and data were analyzed using r/bioconductor and panther analysis tools. confirmative qrt-pcr was performed and protein levels of selected pathways were analyzed by a bead-based western blot system (digiwest â ). immunophenotyping, in vitro differentiation, longterm proliferation and colony forming units (cfu) assays were done for all cell types. results: in vitro exposure of heparin induced differential internalization and lysosomal accumulation in stromal cells, as well as regulation of distinct gene sets, both in a tissue-source dependent manner. affected signaling cascades were mainly involved in proliferation, cell adhesion, apoptosis, inflammation and angiogenesis. the influence of heparin on protein expression and phosphorylation of four pathways (wnt, pdgf, notch and tgfbeta) was further analyzed, revealing most alterations in bm-stcs. independent of origin and medium composition, flow cytometry analysis revealed the characteristic fibroblastoid phenotype profile (cd +/ +/ + and cd -/ -/ -/ -/hla-dr-). in addition a comparable osteogenic and adipogenic differentiation capacity was found summary/conclusions: internalization of heparin in lysosomes by stromal cells, differential gene and protein expression and phosphorylation changes were observed in a tissue-source dependent manner. however, stromal cell characteristics as immunophenotype pattern, long-term proliferation, clonogenicity and in vitro differentiation were unaffected, putatively by post-translational protein modifications. in this respect, application of porcine heparin is compatible with efficient manufacturing of stromal cell based medicinal products abo incompatibility may have no effect on the clinical outcome after allogeneic hematopoietic stem cell transplantation. however, it carries additional risks of hemolytic reactions, delayed red blood cell (rbc) engraftment and incidence of graft-versus patients were categorized according to abo compatible and mismatched groups; these were further sub-categorized into major, minor and bidirectional. direct coombs test (dct) was performed when hemolysis was suspected in the post-transplantation period along with serum lactate dehydrogenase (ldh) %) were male and ( . %) female. mean age of abo matched and mismatched groups were ( . ae . ) years. most common indications for transplant included beta thalassemia major ( . %), aplastic anemia in ( . ) and pure red cell aplasia ( . %). source of stem cell was bone marrow in and peripheral blood patients abo matched while abo mismatched group comprised of ( . %) patients with further subdivision into major (n = ), minor (n = ) and bidirectional in the post transplantation period, packed red blood cell and platelets were transfused in matched group (n = ) and (n = ) comparably(n = ) and (n = ) in mismatched group. primary and secondary graft failure in matched group was . % and . % patients while in mismatched group graft failure was observed in ( . %) patients respectively. positive dct in abo matched group in ( . %) patient, whereas ( . %) patients with major and minor abo mismatch group with raised ldh levels and deranged lfts were found. episodes of acute and chronic gvhd in abo compatible and incompatible groups were insignificant. overall survival in abo summary/conclusions: these results indicate that abo incompatibility does not seem to influence outcome of the patients undergoing allogeneic hematopoietic stem cell transplantation. careful monitoring of patients can help detect problems early and treat them efficiently, thus, reducing the number of life threatening events a picascia , c sabia , f cavalca , g nicoletti and c napoli in our routine work with one lambda sab class ii reagents, we observed non-specific reactivity with some beads bearing dr and dr in patients without sensitizing events. this pattern was not confirmed by testing same sera with screening-and pra-beads suggesting non-specific reactions. aims: here, we sought to determine if fetal bovine serum (fbs) treatment would be effective in reducing/eliminating non-specific reactivity. methods: we tested sera pre-treated with fbs from non-sensitized patients that showed the dr /dr pattern. in particular, ll of fbs was added to ll of patient serum; incubated for min at °c; centrifuged and subsequently tested in the sab assay. as controls, we treated sera from patients with documented dsa including dr /dr and patients without hla antibodies. results: dr /dr non-specific reactivity was eliminated or significantly reduced after fbs treatment. we found that patients with dr and dr dsa had no change in mfi values and additional reactivity was not observed in negative fbs treated sera transfusion medicine, national blood transfusion centre transfusion medicine, national blood transfusion center transfusion medicine, national blood transfusion centre, tirana, albania background: abo blood group, has been associated with many diseases, although the explanation for abo's blood group association and some illnesses is still unclear. aims: to find the distribution of cases by blood groups in patients with malignant pathology compared to donors in order to assess the presence of the abo blood group as an epidemiological indicator to identify populations exposed to different malignant pathologies methods: we conducted a case-control study. abo blood group and diagnosis of all patients have been studied. the control sample was collected from , healthy donors from which group a ( , %), group o ( , %), b ( , %) and group ab ( , %) resulted. the study was conducted in patients who have been transfused and submitted a request to determine the blood group at the blood bank at qsut during the period - results: among the patients, when all malignant pathologies were taken together, the highest frequency was seen in blood group a ( . %), followed by ( . %), b ( . %) and ab ( . %). group a frequency was higher and o was lower compared to controls. a high incidence of blood group a is seen in: pancreatic cancer a ( %), in gastric cancer a ( %), colorectal cancer a ( , %), breast cancer a ( %), cervical cancer a ( %) and ovarian cancer a ( %) versus a ( . %) in the control group. a high incidence of blood b is seen in multiple myeloma b ( %) and cervical cancer b ( %) versus b ( . %) in the control group. blood group ab has a high incidence in malignant lymphoma ab ( %) versus ( . %) in the control group summary/conclusions: it appears that individuals with blood groups a, b and ab are more at risk of developing malignant pathologies and individuals with blood group o are more protected. background: the high homology and opposite orientation of rh genes promote many rearrangements between them and generate a large number of rhd and rhce variants which can be inherited together. several studies have shown that those rh variants in patients with scd represent an additional risk for alloimmunization and delayed hemolytic transfusion reactions (dhtrs), but little clinical or biological evidence related to alloimmunization and dhtr are presented for all the rh variant alleles. it is well established that transfusion recipients with the most common weak d types , and , are not at risk for forming alloanti-d when exposed to conventional rhd-positive rbcs. aims: we report here a case of a -year-old patient typed as weak d type , receiving d+ rbc units who presented anti-d in his plasma detected three weeks after the last transfusion. methods: rhd beadchip (immucor, nj, usa), was performed to identify the rhd variant allele associated with the weak expression of d. rhce genotyping was performed by laboratory developed tests. sequencing of rhd, rhce and rhag were performed to determine if there were other mutations that could explain the production of alloanti-d. serologic testing was by standard hemagglutination methods. the clinical significance of the antibody was evaluated by monocyte monolayer assay (mma). results: serological analysis showed a negative dat and the presence of anti-d in plasma ( + by gel). anti-lw was ruled out. rhd genotyping revealed the patient was rhd*weak d type . rhce genotyping predicted the d+c+c+e-e+ phenotype. sequencing of rhd, rhce and rhag found no additional changes and confirmed the presence of rhd*weak d type . mma showed the anti-d was clinically significant (> %). summary/conclusions: we report the production of alloanti-d in a scd patient with rhd*weak d type allele. weak d type patients are not considered to be at risk for allo anti-d but our results show that there are exceptions and that these anti-d can be associated with clinically significant rbc destruction. background: the mns blood group system is located on glycophorin a (gpa), glycophorin b (gpb) and hybrid glycophorins on the surface of the red blood cell (rbc). these glycoproteins are involved in complex structures interacting with other rbc surface proteins including the band /diego protein. the glycophorins are heavily glycosylated and contains multiple clinically significant blood group antigens. it has proved difficult to model the gpa extracellular structure due to its heavy glycosylation, and lack of homology with existing modelled proteins. aims: to develop an in silico model of gpa as a basis for improved predictions of structure function relationships methods: prediction of secondary structure and disorder: . . predictprotein (https://predictprotein.org); . . spider (http://sparks-lab.org/server/spider /); . . dsc (discrimination of protein secondary structure class): using an in-house implementation; . . jpred (http://www.compbio.dundee.ac.uk/jpred /); . . raptorx (http://raptorx.uchicago.edu). prediction of secondary structure: . . robetta (http://robetta.bakerlab.org/submit. jsp); . . falcon (http://protein.ict.ac.cn/treethreader/); . . itasser (https://zha nglab.ccmb.med.umich.edu/i-tasser/) threading methods to evaluate the quality of protein structures: . . verify d (http://servicesn.mbi.ucla.edu/verify d/); . . prosa (https://prosa.services.came.sb g.ac.at/prosa.php) protein-protein docking: . . gramm-x protein-protein docking web server (http://vakser.compbio.ku.edu/resources/gramm/grammx/); . . gramm (http://va kser.compbio.ku.edu/main/resources_gramm . .php) results: using in silico modelling we derived a stable tertiary glycosylated structure for gpa both as an individual protein and a homodimer. the hybrid glycophorin background: non-invasive prenatal testing of fetal antigen using cell-free fetal (cff) dna from maternal plasma of immunized women is widely implemented into clinical routine but the sensitivity and specificity of the method, especially for genotyping antigens encoded by single nucleotide polymorphisms such as k antigen, is limited by low proportion of cffdna in maternal plasma dna. according to literature reports detection of circulating tumour (ct)dna can be improved by selection of short ctdna fragments using automated electrophoresis methods. aims: the aim was to assess the feasibility for enrichment of cffdna fraction in maternal plasma dna by size selection using the pippin prep gel selection system. methods: plasma dna isolated using easymag (biomerieux) from rhd negative and k-negative pregnant women (n = ) carrying fetuses with known genotype was loaded into % agarose gel casette ( % df marker q , sage bioscience) and size selection of fraction was performed on a blue pippin tm (sage bioscience) with the elution from min to h min of electrophoresis. results for real-time pcr detection of fetal rhd, kel* and ccr (as a marker of total plasma dna) in dna fraction after gel selection were compared to results obtained from non-processed plasma dna. results: the total dna level (measured by ccr ) was significantly lower in dna samples tested after gel selection (from . to . geq/pcr) versus the level obtained from non-processed plasma dna (from to geq/pcr). the results for fetal fraction (measured by rhd) from dna samples of rhd-negative pregnant women carrying rhd positive fetus tested after gel selection were from , to . geq/pcr versus . - . geq/pcr for non-processed plasma dna. results for kel* detection in plasma dna from k-negative pregnant women carrying k-negative fetus were kel* -negative in dna samples tested after gel selection comparing to nonprocessed dna samples were false kel* positive amplification was observed. however, kel* detection in plasma dna from two k-negative pregnant women carrying k-positive fetus gave false kel* -negative results in dna samples tested after gel selection comparing to non-processed dna samples were kel* positive genotype was obtained. the total dna level in samples from k-negative women was from . to . geq ccr /pcr after gel selection versus from to geq ccr / pcr in non-processed dna samples. summary/conclusions: using the pippin prep gel selection system increases the proportion of cffdna fraction in total plasma dna by retaining long maternal dna fragments in the gel cassettes, but the protocol of gel separation dilutes the separated material decreasing the concentration of fetal dna and leading to false negative results of nipt. anti-rh quantification assay using ih- (bio-rad â ): promising results for monitoring rh:- pregnant women j beaud, h delaby, c toly-ndour, a mailloux and s huguet-jacquot centre national de r ef erence en h emobiologie p erinatale (cnrhp), hôpital saint-antoine, paris, francebackground: the generalization of immunoprophylaxis by anti-rh immunoglobulins since complicates the interpretation of the anti-red blood cell antibodies screening during pregnancy. to distinguish an alloantibody from a passive one, many laboratories in france use anti-rh microtitration. it is a column agglutination technology using red blood cells rh: , - , - , , (r r) . it permits to quantify low levels of anti-rh in comparison to a range of an anti-rh standard. performed since at the cnrhp and automated on evo clinical base tecan in (dilutions and distribution), anti-rh microtitration is well adapted to rh prophylaxis. aims: the aim of this study was to evaluate this technique on the ih- system from bio-rad â . methods: on ih- , the reactivity of the bio-rad â reagents was compared with the cnrhp reagents (red blood cells r r, anti-rh standard). the performances of the method were evaluated using three internal quality control (icq) ( cnrhp home-made at and ng/ml and bio-rad â at ng/ml) on papainized r r (plc) and native r r (nlc). a comparison of results from patient sera ranging from . to ng/ml was done between ih- and evo clinical base tecan. results: the results of the qci are similar between the different reagents used. there is no significant difference between the types of red blood cells except for the limit of detection: . ng/ml in plc - ng/ml in nlc. for the qci, the intra and interassay imprecision based on the dilution degree show coefficients of variation between and %, similar to those found with the evo clinical base. the correlation with the cnrhp technique performed on samples in plc and samples in nlc was satisfactory (deming plc: r = . y = . x + . -nlc: r = . y = . x- . ). summary/conclusions: the anti-rh microtitration on the ih- offers similar performances to the method conducted at the cnrhp. the ih- allows automated reading of gel cards. however, it does not have a calculation or interpretation algorithm and does not directly give the concentration of anti-rh . this final part remains manual and requires trained staff. background: haemolytic disease of the foetus and newborn (hdfn) due to maternal-foetal incompatibility has been perfectly framed for decades from the etiologic, pathogenetic and therapeutic point of view. the anti-d alloantibody is most frequently responsible for the most serious form of hdfn due to rhd incompatibility (rhdi hdfn). although immunoprophylaxis (ip) has reduced the number of cases of rhdi hdfn, this disease continues to occur and red blood cell alloimmunization still remains the most common cause of foetal anaemia. hdfn due to abo incompatibility (ab i hdfn) is currently the most common neonatal haemolytic disease in the western world. however, only in about . - % of cases haemolytic disease demands transfusion support. aims: analysis hdfn from to . methods: the hdfn's transfusional support is: intrauterine transfusion (iut) in the antenatal period; exchange transfusion (et) for severe hyperbilirubinaemia and neonatal transfusion of small volumes red cells for the newborn's late anaemia in the postnatal period. our policy for iut, for et and for the neonatal transfusion requires the use of a concentrated blood cells (ec) preferably group rh negative (cde/cde) or negative for any red cell antigens if the mother has antibodies, fresh (< days), preferably cmv safe. for iut, the ec must be compatible with mother's plasma, must have hematocrit + %, and irradiated. the unit for et must be compatible with the newborn's plasma, whit hematocrit % - % and irradiated. the ec used in post-natal transfusions is usually divided into rates of ml, hematocrit ae %. results: in last years, we calculated neonates with hdfn ( males and females): with rhdi hdfn, with ab i hdfn and with hdfn due to incompatibility for other red blood cell antigens. we have produced iut: for our hospitalized patients and for patients located in other hospitals. of these patients, who received iut, were immunized: showed anti-d antibody and antibodies different from anti-a and anti-b. , of the infants with rhdi hdfn, were transfused in utero. neonates on ( . %) have performed et: with ab i hdfn and with rhdi hdfn; the latter had also been transfused in utero. neonates on were transfused after birth: with rhdi hdfn, with ab i hdfn and with hdfn due to incompatibility for other antigens. summary/conclusions: our case studies reflect the literature data. neonates with rhdi hdfn are the most numerous ( . % of the total) and are those who have requested the highest blood supply both in the antenatal period ( . %) that postnatal ( . % performs et, . % performs postnatal transfusions). neonates with aboi hdfn are . %: nobody has received iut, only one has been subjected to et, and % has transfused after birth. patients with hdfn due to other antigens are %, have undergone iut . % and were transfused after birth . %. background: according to british guidelines on neonatal transfusion, since we shared with neonatologists a transfusion protocol for preterm babies. patients are anemic premature newborns with a gestational age ≤ weeks and/or a birthweight lower than g, until months of age. aims: reduce the incidence of iatrogenic anemia. methods: pre-transfusion tests were based on ab direct test, rh phenotype, direct and indirect antiglobulin test (dat, iat). a second blood sample was required for ab /rh confirmation. blood transfusions were performed with negative kell negative ( cde/cde/kk) cmv negative irradiated erythrocyte concentrates (ec) of less than days. ec were subdivided in ml aliquots with a hematocrit of ae %. according to the definition of "small volume transfusions", our protocol established that further four transfusions had to be delivered free of testing. after the fifth ec transfusion the supplementary release of ec was provided of type and screen (t&s) test with h of validity. serological investigation and full compatibility testing were applied in the presence of a iat and/or dat positivity and in the case of mother alloimmunization. results: from october to the end of , premature newborns received ec transfusions within their first months of life. in % of cases (n = ), transfusion requirement was comprised within the 'small volume transfusions'. another % of cases (n = ), requiring further ec administration, was requested of a blood sample for t&s determination and % (n = ) for a cross-match test. in . % of newborns (n = ), being transfused within the " small volume transfusions", blood requirement of ec was fulfilled by the initial blood test ( blood samples). . % of newborns (n = ) received more than transfusions ( - ; median = ) accounting for ec released and for this group blood samples were required. summary/conclusions: with the exception of babies requiring crossmatch test, blood tests were performed to sustain infants transfused with units. the alternative option of omitting crossmatch test (otherwise suggested by italian directives), allowed a reduction of % of blood drawn without any adverse effect or incident reported. due to the relevance of anemia in premature babies, we suggest the application of this transfusion policy in all newborns in the first months of life. background: glucose- -phosphate dehydrogenase deficiency (g pdd) is a sexlinked enzymopathy which is usually asymptomatic unless individuals are exposed to oxidative stress agents. the g pd genotype is the most common g pd genotype in sub saharan africa (ssa). some studies have linked blood from g pdd donors to poor outcome of a transfusion. however, there are no genetic screening programmes for blood donors in the region hence the contribution of g pdd to the donor pool in the ssa setting had not been described.aims: this study aimed to describe the prevalence of g pdd genotype among donors in two regions in uganda. it also described the effect of g pdd and the coinheritance of haemoglobin s and a-thalassaemia on the haematological quality of blood. methods: , blood samples from donor packs were utilized in a transfusion trial conducted in uganda, were genotyped for g pd , haemoglobin s and a-thalassaemia. haemoglobin and haematocrit measurements for the donor units (packs) at the time of transfusion were used to describe the effect of g pd and co-inheritance with a-thalassaemia (n = , ) and haemoglobin s (n = , ) on the haematological quality of blood packs. a subset of donor blood packs was utilized to determine the sensitivity and specificity of the carestarttm rapid diagnostic kit (rdt) for g pdd. results: based on g pd genotyping, . % (n = ) of the blood samples used in the trial were deficient for g pd enzyme while . % (n = ) were heterozygous. significant lower hemoglobin values were observed in red cell concentrates (p = . ) and whole blood (p = . ) donations of heterozygous g pd genotype. co-inheritance of g pdd and a-thalassaemia resulted in significantly lower haemoglobin levels. the carestarttm rdt test was . % sensitive and . % specific for detecting donor blood packs with g pdd. summary/conclusions: the prevalence of g pdd among ugandan blood donors was similar to that in the general population. the heterozygous genotype resulted in lower haemoglobin concentration of the blood units. the use of carestarttm rdt for screening of stored blood units was not as efficient in this study hence further testing for the determination of g pdd needs to be done on fresh samples from donors. transfusion medicine, jaypee hospital, noida, india background: during last two decade there has been a continuous remarkable improvement in desensitization therapy in high risk hla sensitized kidney recipients. in india there has been a tremendous increase in the number of kidney transplantations in patients having anti-hla antibodies (hla sensitized) with excellent success rate. aims: in present study, we are describing successful role of desensitization in hla sensitized patients having preformed donor-specific hla antibody (dsa). methods: all patients were preconditioned with combined modality of a standard dose of rituximab, therapeutic plasma exchange (tpe) and low dose ivig. tpe was started using com. tec (fresenius kabi, germany) after days of administration of rituximab. complement dependent cytotoxicity cross match (cdc-xm), luminex cross match with donor lysates (lm-xm, immucor inc., ga, usa) and flow cytometry cross match (fc-xm, bd facs canto ii).) was done in all cases. if any of the three tests was positive, single antigen bead assay (sab) was performed. desensitization therapy was given in all cases where dsa was detected. pretransplant tpe procedures were done until dsa (mfi < ) and cdc-xm became negative. cdcxm labeled positive at ≥ %. t-cell fcmx was considered positive above mfi and b-cell fcmx was considered positive above mfi. lmxm was considered positive above mfi. sab was performed using lifecodes single antigen (lsa) class i and class ii kits (immucor, usa). if the specificity of anti-hla antibodies was against donor hla antigen(s) it was called as donor specific antibody (dsa). results: present study demonstrated the diagnostic and clinical superiority of adding fc-xm and lm-xm in pretransplant compatibility testing algorithm over cdc-xm. cdc-xm alone was not able to detect anti-hla antibody in patients ( . %). among the three pretransplant compatibility tests, fcxm demonstrated highest sensitivity. among the cases initially screened showed dsa positivity in sab. desensitization was done in those cases only. in our study, sab was positive for class ii alone in ( %) while in remaining ( %) cases it was positive for both class and class ii. the number of pre transplant tpe procedures required was . ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . the mean number of post-transplant tpe sessions required was . (range, - ). during pretransplant and post transplant tpe procedures, five ( . %) patients presented with allergic or hypotensive reactions which were managed conservatively. most of the patients were discharged after seven days of hospital stay whereas patients who required post-transplant tpe were discharged after a relatively longer hospital stay (mean- . , median- days). after three months, protocol biopsy was done in those cases only where post transplant tpe was required. protocol biopsy showed normal findings. in present study, the mean duration of follow up was approx months with the longest duration of follow up of months. summary/conclusions: in a country like india where there is a huge gap in the demand and supply of kidney and a large no. of patients waiting for a suitable organ, transplant across hla barrier could a good doable option. thorough pretransplant compatibility and tpe are essential tools to make these transplants program successful background: most transfusion-dependent chronically anemic patients are managed by simple red cell transfusions. however, some patients are not able to tolerate the additional volume associated with simple transfusions and are at a high risk of developing transfusion associated circulatory overload, if transfused with multiple red cell units. plasma-to red cell exchange (prx) is a modified procedure wherein an apheresis machine is used to remove patient's plasma, while simultaneously replacing with donor rbcs. this procedure allows for a rapid euvolemic transfusion of rbcs to patients that are severely anemic and intolerant to excess fluid volume. others as well as our group have previously described this procedure. we now summarize our institutions nearly seven years of experience performing this procedure on a routine basis. aims: to document patient experience with prx. methods: we performed a retrospective chart review of all patients that underwent prx at our institution in the last seven years. our protocol for prx has evolved during this period. currently, we perform the procedures using spectra optia (terumo bct, lakewood, co) machine using the plasma-exchange program and tubing set. if the patient's pre-procedure hematocrit (hct) is < %, we custom prime the tubing set with % albumin. the number of red cell units transfused to the patient depends on their pre-procedure hematocrit and is individualized to the patients. results: we have treated four patients with prx procedure. patient # is a -year-old transfusion-dependent male with beta-thalassemia major. the patient had experienced multiple congestive heart failure exacerbations secondary to simple transfusions and we consequently performed prx procedure, every weeks, starting in . the patient has completed procedures with - units of washed red cells transfused to achieve a target hct goal of to %. he tolerated all procedures without any volume overload issues. he continues on this transfusion regimen. patient # was a -year-old female who had symptomatic anemia secondary to sickle cell disease (hb ss complicated by end-stage renal disease (esrd). she had progressively become intolerant to simple transfusions, including an episode of severe dyspnea, which required intubation. she underwent prx procedures with - units of washed red cells. patient tolerated the procedures without any significant complications. however, during a different surgical procedure, she experienced cardiac arrest and subsequently passed away. patient # is a -year-old transfusion-dependent male with severe anemia secondary to sickle cell anemia (hb ss). he was intolerant to excess fluid because of esrd and congestive heart failure. he has undergone prx procedures with - red cell units transfused to achieve a hct goal of %. he tolerated all procedures without any volume overload issues. he continues on this transfusion regimen. patient # is a -year-old male with a sickle cell disorder (hb ss) complicated by esrd, heart failure and chronic hypoxemic respiratory failure. the patient has undergone two prx procedures with - red cell units. other than an episode of non-bloody emesis that was symptomatically treated, he tolerated both procedures. he continues to be managed on this regimen. however, the patient remains noncompliant with treatment. summary/conclusions: prx is a safe and efficient method to transfuse multiple red cell units to volume-intolerant anemic patients. background: transplanted organ failure due to antibody mediated rejection in abo-compatible organs is a serious complication with a bad prognosis. the goal treatment in these cases encompasses the following strategies: adjustment of the immunosuppressive medications, ivig infusion, antibody removal by therapeutic plasma exchange, and/or the use of target-specific monoclonal antibody medications to lymphocytes, plasma cells, and/or complement. the american society for apheresis has assigned a category i to the use of therapeutic plasma exchange for the treatment of abo-compatible antibody mediated rejection in kidney, but a category iii to all other abo compatible organs: liver, lung, and heart. at our institution, a standardized approach for the use of therapeutic plasma exchange as a supportive intervention for abo-compatible immune mediated rejection, regardless of the organ type, has been in place since . aims: a retrospective review was performed to evaluate our patient outcomes using therapeutic plasma exchange for the treatment of antibody mediated allograft rejection in abo-compatible solid organ transplantation. methods: patients used for the retrospective review were selected from an existing therapeutic apheresis list. the therapeutic plasma exchange protocol consists of: adjustment of the immunosuppressive medications, ivig infusion, antibody removal by therapeutic plasma exchange, and/or the use of target-specific monoclonal antibody medications to lymphocytes, plasma cells, and/or complement. it is performed as follows: one plasma volume exchange is performed on days , , , , , along with one or more of the above strategies followed by an ivig infusion. cases with allograft rejection in which plasmapheresis was not used were excluded. and t devos aims: this study aimed to explore the possible causes of the decreased transfusion rate for all adult cardiac surgery patients. methods: data were collected from adult cardiac surgery patients during the mentioned time frame and were extracted from electronic patient files and a database of the department of cardiac surgery. a set of variables was defined as possible confounders by a panel of experts. after discussion, global variables (age, gender, duration of surgery, use of cpb (cardio-pulmonary bypass), american society of anesthesiologists (asa) risk score, type of surgery, urgency, attending cardiac surgeon and attending anesthesiologist) and cpb-related variables (administration of cardioplegia yes/no (cpg), duration of cpb, circulatory arrest, hypothermia, duration of aortic cross-clamp, baseline hemoglobin and cpb-priming volume) were retained. negative binomial models for counts were used for data analysis. all analyses were performed with spss. results: patients were extracted from databases and further analyzed. the mean age of this group was , years (sd +/- , years) and . % of them were male. the mean duration of surgery was min (sd +/- , min). the decrease of perioperative rbc transfusion rate over four years was statistically significant (p < . ). in , the mean use was , units per operation (sd +/- , ), which changed to , units (sd +/- , ) in . three variables (urgency, attending cardiac surgeon, attending anesthesiologist) changed significantly over years and were used in a multivariable model as confounders together with rbc transfusions and year. even after adjustment for these factors, the decrease in rbc transfusion rate was still statistically significant (p < . ). in the specific group of patients undergoing cardiac surgery with cpb (n = ), the use of rbc was also significantly reduced (p < . ). in , the mean use was , units per operation (sd +/- , ) and this changed to , units (sd +/- , ) in . after correction for the cpb variables that notably changed over the years (cpg, priming volume and hypothermia) and the three previously defined confounders (urgency, attending cardiac surgeon and attending anesthesiologist) the reduction of rbc transfusions over years still remained statistically significant (p < . ). summary/conclusions: our study shows evidence for a decreased rbc transfusion rate in adult patients undergoing cardiac surgery between and . this tendency was also seen in the subgroup of patients undergoing surgery with cpb. possible explanations of the decrease are implementation of various established parts of patient blood management. however, a unique reason could not be identified in this study. background: growing worldwide demand for immunoglobulin products such as intravenous immunoglobulin (ivig) and subcutaneous immunoglobulin (scig) is driving plasma collection. patients with primary immunodeficiency (pid) or secondary immunodeficiency due to haematological malignancy or its treatment (sid) rely on these products to maintain therapeutic serum igg levels to minimise recurrent infection. efficacy of immunoglobulin replacement therapy (irt) in pid is well established but information on sid is limited. the different aetiologies of hypogammaglobulinaemia between pid and sid raised the question of whether sid patients on irt experience similar clinical and quality of life (qol) benefits as reported in pid patients. aims: to assess whether sid patients experience similar clinical and qol benefits while on irt as pid patients. methods: following ethics approval, data on dosage, serum igg trough levels and infection (bacterial, viral and fungal requiring treatment such as antibiotics) was collected from adult pid and adult sid patients from medical records and pathology reports, for their last months of ivig and their first months of scig. the starting and maintenance dose was . g/kg/month for ivig, transitioning immediately to . g/kg/week for scig without a washout period. a study specific questionnaire was developed to gather data on patient perceived side effects, treatment satisfaction and impact of irt on social/family life, work/study and their overall qol. paired t-test was used for parametric data and the wilcoxon signed-rank test for non-parametric data. results: sid patients were significantly older with a mean age of . years versus . years in pid patients (p = . ). a mean of three training session was required to reach competency in scig administration in both cohorts. there was a trend of reduced side effects on scig for pid and sid patients compared to ivig, with a significant reduction of headaches in the pid cohort (p = . ). the majority of patients experienced infusion site reactions, which were predominantly perceived as manageable. % of infections were respiratory tract infections. pid patients had slightly higher mean serum igg trough levels with scig ( . g/l) compared to ivig ( . g/l), and fewer infections on scig than ivig (mean annual infection rate of . vs . respectively). sid patients had higher mean serum igg trough levels on scig ( . g/l) than ivig ( . g/l) (p = . ) but experienced more infections while on scig versus ivig (mean annual infection rate of . vs . respectively). the number of hospitalisation due to infection decreased in both cohorts with scig. pid patients perceived that switching from ivig to scig improved their health and qol. in contrast sid patients perceived no improvements in health and qol. summary/conclusions: data from this pilot study suggests that the clinical and qol impact of irt in sid patients is different to that of pid patients. to support evidence based irt management and effective use of this limited and expensive blood product in sid, larger studies which account for different stages of malignancy and associated treatment regimes are required. background: there is an increasing platelet transfusion for treatment and prophylaxis of bleeding in patients with hematologic disorders and malignancies. because of limited resources, leukoreduced platelet concentrates is not yet implemented in most indonesian hospitals. in vitro platelet activation may cause morphology, functional, and ultrastructure changes. those changes will reduce the platelet viability, in vivo functions, and clinical efficacy. high platelet cd p expression is the cause of faster platelet destruction in the reticuloendothelial systems. post-transfusion in vivo hemostatic efficacy can be determined by the measurement of corrected count increment (cci), recovery, and platelet cd p expression. aims: to analyze the increase of platelet cd p expression in patients of non-leukodepleted compared to pre-storage leukodepleted pc transfusion.background: haemorrhage is a leading cause of preventable death not only in the military trauma care, but also for civilian population suffering accidents or bleeding injuries in regions with low population density where health services should reach people in remote areas. resuscitation using blood products and limited infusion of normal saline improves survival for critically bleeding patients. nowadays there are hems programs (helicopter emergency medical system) carrying blood products around the world. the hems in castilla-la mancha, with physician and nurse, is the first out-of-hospital emergency service in spain that provides packed red blood cells (prbc) transfusion where the accidents happen without delaying the transport to the proper hospital for definitive treatment. this program has been developed between the blood center of ciudad real and the hems team ('gigante ', emergency service castilla-la mancha). the goal of the designed protocol was to preserve the properties of the product to be transfused in out-of-hospital environment by hems teams. aims: to describe the process for out-of-hospital prbc transfusion in hems of ciudad-real. the protocol for out-of-hospital blood transfusion was developed according to criteria of medical indications and security, monitoring, and tracking of the product. methods: data for the observational retrospective study were collected from june to august . the medical helicopter (ec t ) was provided with two prbc o rh(d) negative. the shock index was selected for the indication for transfusion according to the literature revised and as a simple rate to obtain out-of-hospital data. to achieve the feasibility and preservation of the prbc a prospective monitoring of volume was established, haematocrit, haemoglobin, leucocytes, coulter, hemolysis and microbiological culture. blood center established two groups: the case group for the prbc kept in the hems base and helicopter and the control group for the units remaining in the blood center with standardized blood conservation. for both groups, control and comparison of immediately obtained hematologic analyses, and days after collection, were performed. the statistical analysis used spss . version (significance p < , ). results: prbc samples were evaluated, , % ( ) from case group and , % ( ) from control group. analyses were tested day and day after collection. haemolysis was not observed. all cultures were negative. although significant differences were found between the parameter in the value of before-after in the value of the hematocrit, leukocytes and coulter, there are no differences between the prbc that flew and those conserved in the transfusion-service. all results comply with current legislation and blood transfusion standards. there have been administered prbc transfusion to patients during out-of-hospital advanced medical assistance. no post-transfusion reactions have been registered. prbc units have a -day rotation to allow the use of the units in the hospital after achieving their optimal status. summary/conclusions: the out-of-hospital transfusion protocol designed to transport blood (prbc) in the helicopter for hems has demonstrated to keep the standard conditions and properties of the product to be considered useful in the treatment for critically bleeding patients in the out-of-hospital. background: early and adequate treatment of major bleeding is important for survival and a good outcome. blood and plasma are given increasingly early including before hospital admission in trauma based on successes reported from combat experience. in the national patient safety agency issued a rapid response report requiring national health service hospitals in england to take actions to improve provision of blood in an emergency including provision of major haemorrhage protocols (mhp) and drills. the national reporting and learning scheme had identified reports of deaths and instances of harm due to delay over a -year period. aims: the aim of the study was to monitor the acid-base status of the patient by means of abg and to administer the blood component therapy based on teg results. methods: this study was a prospective observational study of adult patients over a period of months. serial monitoring of the abg in the intra-operative period was done. teg guided resuscitation was performed in all cases. results: the abg analysis of all patients showed decrease in the ph, increase in pco , decrease in serum bicarbonate level and elevation in negative base excess. these components of metabolic acidosis can be attributed to massive transfusion. increased lactate, an independent parameter, which reflects poor tissue perfusion or shock and predicts need for massive transfusion was observed in all patients. all the cases showed a decrease in ionized calcium levels which could be a result of citrate related toxicity. increased glucose was observed in all patients which may be due to increase in the catecholamine release as a response to haemorrhagic shock. electrolyte correction was given depending on results of the abg analysis wherever appropriate. two out of cases showed an increase in r time indicating deficient coagulation factors, which was corrected with fresh frozen plasma (ffp). three cases showed elevation in k time indicating deficient fibrinogen levels, which was corrected by ffp. fresh frozen plasma was also given in cases, which showed decrease in the alpha angle, indicating deficient fibrinogen, and cryoprecipitate was given in cases. platelets were transfused in patients showing a decrease in the maximum amplitude (ma), which indicates deficient platelets. summary/conclusions: teg as poc testing is an important tool in appropriate blood component therapy in massive transfusions. serial monitoring of abg helps in monitoring acid-base status of the patient and therefore is a guide in the correcting electrolyte level in patients undergoing massive transfusion. background: massive blood loss is encountered in various situations like trauma, major surgeries, gastrointestinal bleeds and obstetric haemorrhages. haemorrhage is an important cause of mortality and morbidity in massively bleeding patients. early recognition of haemorrhage and intervention is essential for survival. massive transfusion (mt) of blood is required to replenish blood losses and is a lifesaving treatment in these patients. a variety of haemostasis and pathophysiological changes occur during massive haemorrhage and massive transfusion. all of these changes contribute to the vicious cycle of progressive coagulopathy due to the 'lethal triad' of refractory coagulopathy, progressive hypothermia and persistent metabolic acidosis. aims: the aims of the study included understanding management of cases of massive blood transfusion in surgical patients, impact of mt of blood components on patient outcome, evaluating post-operative complications of massive transfusion and the development of institutional massive transfusion protocol (mtp).methods: this prospective observational study commenced after institutional ethics committee (iec) approval. it comprised of adult surgical oncology patients who received massive transfusions and was conducted for a period of months. every case of a massive transfusion was studied under the following headings ( ) patient's details ( ) patients base-line laboratory tests ( ) resuscitation with transfusion ( ) intra-operative laboratory tests ( ) thromboelastography (teg) ( ) post-operative complications ( ) duration of stay in the hospital ( ) day mortality rate. results: complete blood count, serum electrolytes, arterial blood gases, coagulation profile and teg were used to monitor transfusion therapy in the intraoperative period. intraoperative laboratory parameters of patients showed dilutional coagulopathy, metabolic acidosis, hypocalcaemia, hypomagnesaemia, hyperkalaemia and hypokalaemia, increased lactates and glucose. electrolyte correction was done based on the derangement. the derangements were on a decreasing trend in the postoperative period and returned to baseline level by nd or rd post-operative day with no requirement of correction in the post-operative period. the post-operative outcomes were evaluated in terms of the surgical site infection (ssi) as per the centers for disease control (cdc) criteria, surgical complications as per modified clavien-dindo classification and respiratory complications. a total of ( . %) patients had ssi, ( %) had surgical complications and ( %) patients had respiratory complications. the length of the stay in the hospital was longer for patients who had postoperative complications. despite complications, owing to excellent peri-operative care, ( %) patients were discharged alive. summary/conclusions: surgeries associated with massive transfusion are at an increased risk of ssi as well as morbidity and mortality. complications associated with rapid transfusions of blood, acute haemorrhage and associated risk of the surgery lead to a prolonged icu stay and increased length of stay in the hospital. a well-developed massive transfusion protocol optimizing the ratio and dose of the blood component therapy results in excellent patient outcome with minimal postoperative morbidity and mortality. background: despite the introduction of new oral anticoagulants (dabigatran, rivaroxaban, apixaban), vitamin k antagonists (vka), such as warfarin and acenocoumarol are still the most widely used oral anticoagulants for the treatment of non-valvular atrial fibrillation (nvaf). the use of vka must be regularly and often laboratory controlled in order to ensure the adequacy of therapy and to avoid subdosing or drug overdose. the most commonly used test for the control of oral anticoagulant therapy is the prothrombin time (pt), expressed in inr system, which provides an internationally standardized monitoring of the treatment. time in therapeutic range (ttr) represents a measure of the quality of the anticoagulant effect of vka and estimates a percentage of time a patient's inr is within the desired therapeutic. aims: the aim of this study was to evaluate of the effectiveness of vka therapy in patients with nvaf and to identify factors affecting the anticoagulation efficacy. methods: a retrospective study was conducted on a population of outpatients with nvaf, treated with vka and followed in blood transfusion institute of ni s from january to december . laboratory control of inr was done from capillary blood of patients on thrombotrack solo (axis shield, norway) and thrombostat (behnk elektronik, germany). targeted ae . %, but . % of patients had a ttr less than %. patients were at high risk of thrombosis in . % of time (inr < . ) and high risk of bleeding in . % of time (inr > . ). the most significant independent factors affecting the quality of vka therapy are gender, arterial hypertension, diabetes mellitus and the use of amiodarone and antiplatelet drugs (aspirin, clopidogrel). summary/conclusions: the ttr is undoubtedly useful indicator of the effectiveness of vka treatment. the most important predictors of poorer efficacy of vka therapy are arterial hypertension, diabetes mellitus, patients' gender and the use of amiodarone and antiplatelet (aspirin, clopidogrel) drugs. to improve the quality of vka therapy, education of patient and better collaboration with them, as well as a successful teamwork with clinicians are also imperative. background: an estimated . million deaths per year result from haemorrhagic blood loss. at a cellular level, haemorrhagic shock develops when oxygen delivery is insufficient to meet oxygen requirements to maintain aerobic metabolism. successful resuscitation prevents further oxygen debt and repays the prior oxygen debt. this includes the administration of fluids and blood components (e.g. plasma, red cells and platelets). measurement of oxygen delivery and utilisation at a tissue level requires invasive monitoring not possible clinically, meaning that surrogate markers such as lactate and venous oxygen saturation (svo ) are used instead. new technologies such as incident dark field imaging and near-infrared spectroscopy may offer a non-invasive alternative; however their utility in haemorrhagic shock remains background: transfusion-induced red cell alloimmunization is still a major challenge in transfusion practice. besides logistic problems for the transfusion laboratory, it may compromise available blood supply, and when undetected and unanticipated, it may risk haemolytic transfusion reactions. knowledge about risk factors can help to optimize preventive matching strategies. severe renal failure and subsequent renal replacement therapy influence the immune system and could therefore modulate the risk of alloantibody formation against foreign red cell antigens subsequent to transfusion. aims: this study aims to quantify the association between renal failure, according to its degree and its treatment with renal replacement modalities, and transfusioninduced red cell alloantibody formation. methods: we performed a multicenter case-control study within a source population of patients receiving their first and subsequent red cell transfusion between and in the netherlands (risk factors for alloimmunization after red cell transfusion, r-fact study). using a conditional multivariate logistic regression, we compared first-time transfusion-induced red cell alloantibody formers (n = ) with two similarly exposed non-alloimmunized control recipients (n = ) during a five-week alloimmunization risk period. degree of renal function was categorized as: 'no renal failure' i.e. glomerular filtration rate (gfr) > ml/min/ . m , 'moderate renal failure' i.e. gfr ≥ - ml/min/ . m during a continuous period of minimally seven days, 'severe renal failure' i.e. gfr < ml/min/ . m and/or use of any type of renal replacement therapy during at least one day of the alloimmunization risk period. odds ratios were interpreted and presented as relative risks (rr). adjusted rrs were conditioned on the matching variables and identified confounders. results: no renal failure was observed among ( . %) cases versus ( . %) controls; moderate renal failure among ( . %) cases versus ( . %) controls; and severe renal failure among ( . %) cases versus ( . %) controls. among the latter, cases and controls underwent renal replacement therapy. moderate renal failure and severe renal failure without renal replacement therapy were not significantly associated with red cell alloimmunization (adjusted rr . , % ci . - . and adjusted rr . , % ci . - . , respectively). however, patients undergoing renal replacement therapy had a two-fold lower alloimmunization risk (adjusted rr . , % ci . - . ) as compared to transfusion recipients without renal failure, unrelated to type and duration of renal replacement therapy. summary/conclusions: these findings suggest that patients undergoing renal replacement therapy have strongly diminished red cell alloimmunization risks. further research should confirm these results and elucidate the underlying pathophysiological protective mechanism. background: the ability of allogeneic hematopoietic stem cell transplantation(allo-hsct) to prevent relapse depends partly on donor natural killer (nk) cell alloreactivity. nk effector function depends on specific killer-cell immunoglobulin-like receptors (kir) and hla interactions. thus, it is important to identify optimal combinations of kir-hla genotypes in donors and recipients that could improve hematopoietic transplantation outcome. aims: to obtain the optimal combinations of inhibitory kir and its ligand between donor and recipient which is helpful for the guidance of selecting donors and recipients in hsct. methods: the pcr-sbt method was used for kir dl , kir dl /kir dl , kir dl , kir dl and hla-a, -b, -c, -drb , -dqb genotyping. pairs of hla / identical donor/recipients matching samples were retrospectively analyzed. three different models of kir were established. there were kir-kir gene model, kirligand model and haploid model. in kir-ligand model, patients were divided into three groups: c /c homozygote group ( cases), c /c heterozygote group ( cases) and c /c homozygote group ( cases). according to the expression of dl , cases were dl positive and cases were dl negative. there were cases of bw /bw , cases of bw /bw and cases of bw /bw in the dl positive samples. according to the expression of a /a , they were divided into three groups: a /a negative group ( cases), a /a heterozygous group ( cases) and a / a homozygote ( cases). according to kir genotyping, kir haploidentical group ( cases) and kir haploid mismatched group ( cases) were divided. the clinical data on neutrophil and platelet remodeling time, gvhd and os of cases were statistically analyzed by the mann-whitney test or the kruskal-wallis test using graph-pad software v . . results: there was no significant difference in the time of neutrophil and platelet remodeling, the incidence of agvhd and the survival time after transplantation in the kir genotype model. in haplotype model, there was no significant difference in neutrophil and platelet remodeling time and survival time after transplantation. the incidence of agvhd was low when the kir haploid mismatched and kir dl was positive. it was conducive to neutrophil and platelet remodeling when bw /bw and a /a was heterozygosity. summary/conclusions: it is important to establish the three different models of kir genotypes, haplotypes and receptor-ligand mismatches for analyzing the effect on the prognosis of allo-hsct. kir-ligand model plays an important role in hla unre-background: transfusion of platelet concentrates (pcs) has been associated with adverse outcomes including transfusion-related acute lung injury (trali). the underlying mechanism of trali has been related to the accumulation of immunomodulatory mediators (e.g. lipids, cytokines/chemokines) present in pcs. current room temperature storage limits the shelf-life of conventional pcs to - days. alternative storage conditions, including cryopreservation, offers extended storage and a solution for blood banking logistics. cryopreservation of human pcs has been associated with higher concentrations of immunomodulatory mediators compared to room temperature stored pcs and it has been suggested that cryopreserved pcs may be immunomodulatory. to investigate the effects of cryopreserved pcs, a transfusion sheep model would be a beneficial approach. aims: to characterize immunomodulatory mediators in supernatants of sheep conventional and cryopreserved pc and to investigate whether storage duration and cryopreservation impacts the accumulation of these mediators. methods: buffy coat pooled sheep pcs (n = ), prepared in % plasma/ % ssp+ with minor modifications to standard human procedures, were stored room temperature (rt) for days (d) and sampled on d , d and d . cryopreserved sheep pcs (n = ), prepared by the addition of - % dimethyl sulfoxide, were stored at À °c and sampled pre-freeze and post-thaw. supernatant was prepared at each time point with double centrifugation and stored at À °c. concentrations of pro-inflammatory cytokines (interleukin (il)- , il- b, il- a), anti-inflammatory cytokine il- and chemokines (il- , monokine induced by gamma interferon (mig) and interferongamma induced protein (ip)- ) were measured using sheep specific in-house and commercial enzyme linked immunoassays (elisa). levels of non-polar lipid mediators, such as arachidonic acid (aa), -hete and -hete were assessed in the stored sheep pc-and cryo-pc supernatant using commercial elisa. results shown as mean ae standard deviation. the effect of storage was determined at p < . using paired t-test. results: in rt stored sheep pc supernatant il- , il- b, il- a, il- , il- , mig, ip- , -hete and -hete were detected at d , d and d . storage duration significantly increased accumulation of ip- at d ( . ae . pg/ml compared to . ae . pg/ml, p = . ) and further increased at d , and il- at d ( ae . pg/ml compared to ae . pg/ml, p = . ). cryopreserved sheep pc supernatant pre-freeze and post-thaw contained equivalent or higher concentrations of il- , il- b, il- a, il- , il- , mig, ip- , -hete and -hete than rt stored d pcs. however, cryopreservation did not impact levels of any of the platelet derived mediators. summary/conclusions: several platelet-derived cytokines/chemokines, including high concentration of il- with neutrophil priming activity, and non-polar lipids were found in stored sheep pc supernatant. these immunomodulatory mediators may contribute to adverse outcomes associated with pc transfusion. storage at rt, but not cryopreservation was associated with increased accumulation of immunomodulatory mediators in sheep pcs. most importantly, similar to human pcs, sheep cryopreserved pcs contained at least if not higher concentrations of majority of cytokines as pcs stored at rt, therefore making sheep a suitable model in which to investigate immunomodulatory effects of cryopreserved pc transfusion. background: transfusion, despite being a lifesaving therapy, has been associated with adverse transfusion outcomes. transfusion related acute lung injury (trali) remains one of the leading causes of transfusion-related mortality. accumulation of immunomodulatory mediators (e.g. lipids, cytokines/chemokines) present in blood products, including packed red blood cells (prbcs), have been implicated with the development of non-antibody mediated trali. however, how specific mediators contribute to the underlying mechanism is yet to be defined. during routine storage of human prbcs fewer than cytokines/chemokines and several biologically active lipids have been identified. a sheep model of trali has successfully been developed using human prbc supernatant, however transfusing sheep prbc has not been investigated. to support the use of sheep prbc in the trali model and to better understand the precise mechanism, characterization of the potential mediators in sheep prbc is required. aims: to characterize immunomodulatory mediators in sheep prbc supernatants and to investigate whether storage duration impacts the accumulation of these mediators. methods: sheep prbcs (n = ), prepared according to standard human procedures with minor modifications, were stored ( - °c, days (d) ) and sampled at d and d . supernatant was prepared by double centrifugation and stored at À °c. concentrations of pro-inflammatory cytokines (interleukin (il)- , il- b, il- a), antiinflammatory cytokine il- and chemokines (il- , monokine induced by gamma interferon (mig) and interferon-gamma induced protein (ip)- ) were measured using sheep specific in-house and commercial enzyme linked immunoassays (elisa). levels of potential non-polar lipid mediators (arachidonic acid (aa), -hydroxyeicosatetraenoic acid (hete) and -hete) were assessed in the sheep prbc supernatant using commercial elisa. paired t-test was used to compare fresh and stored prbc supernatant (p < . ). results are mean ae standard deviation. results: at day , aa ( , ae , pg/ml), -hete ( . ae . pg/ml), -hete ( . ae . pg/ml) and il- b ( . ae . pg/ml) were detectable in sheep prbcs supernatant. at day , storage duration significantly increased concentrations of aa ( , ae , pg/ml, p = . ) and -hete ( . ae . pg/ml, p = . ) in sheep prbcs supernatant. summary/conclusions: similar to reported findings of human prbcs, the predominant type of immunomodulatory mediators present in sheep prbcs were non-polar lipids. the concentration of these non-polar lipids increased during storage. these immunomodulatory mediators may contribute greatly to adverse outcomes associated with prbc transfusions. further investigation is required to determine whether stored sheep prbcs supernatant induce immunomodulation in sheep in vitro and in vivo transfusion models. background: dshtr incidence is reported as in , transfusions, presenting days to months after the transfusion. the published data addressing the correlation between the strength of the antibodies detected after a dshtr has taken place and the corresponding clinical symptoms as measured by laboratory parameters that assess the presence of hemolysis is limited. aims: the aim of this study is to evaluate the correlation between the results of the dat, automated and manual antibody reactivity strength with the corresponding clinical parameters of hemoglobin, lactate dehydrogenase (ldh), bilirubin, and haptoglobin. methods: a dshtr is defined as discovering a new antibody within days of a transfusion. for all positive antibody screens, a work-up is initiated consisting of identification panels, dats, antigen typing of the red cells transfused, and eluates at the discretion of the transfusion medicine physician. additional laboratory testing for hemolysis is requested when indicated. a retrospective review was conducted of patients who were identified as having a dshtr. levels of hemoglobin, ldh, and transfusion safety background: rhd immunoglobulin (rhdig) has been available for years in australia. since its introduction for routine antenatal and postpartum prophylaxis, alloimmunisation has decreased from % to . %, reducing the number of australian deaths from haemolytic disease of the newborn over a hundred-fold, to approximately . deaths per . blood matters serious transfusion incident reporting (stir) system has been collecting transfusion incidents and adverse events across four australian jurisdictions since . since january , rhdig administration errors have been reported. aims: to understand incidents relating to the administration of rhdig and increase safety and awareness of risks. methods: health services registered with stir (n = ) were notified of the inclusion of reporting rhdig incidents. when an incident is identified, the reporter sends an online notification to stir, prompting the appropriate investigation form to be sent for completion. the completed incident data are reviewed and validated by an expert group. data is de-identified and collated for reporting. results: during the period january -december , reports were received; reports were validated, with reports excluded (reactions rather than administration errors). reports were categorised as below: background: following the nice transfusion guidelines, recommending offering iron before and after surgery to patients with iron-deficiency anaemia (ida), we worked collaboratively with the anaesthetic and pre-operative team to implement a clear and robust anaemia pathway for pre-operative haemoglobin (hb) optimisation. oral iron was started, where appropriate, and our anaemia pro-forma was sent for review in a virtual clinic to assess eligibility for intravenous iron. we performed a retrospective evaluation of the patients who received iv iron during the anaemia pathway. aims: the aim of this retrospective evaluation was to look at the cohort of patients who had received iv iron in and assess the effect of iv iron on haemoglobin levels for different defined groups. methods: we classified patients, as described in munting and klein, , depending on their iron parameters as having either: -idaserum ferritin < mg/l -chronic inflammation with idaserum ferritin - mg/l with transferrin % of < %/crp > mg/l -anaemia of chronic inflammationserum ferritin > with transferrin % of < %/crp > mg/l patients were considered eligible for iv iron if the following criteria were met: . an inadequate response to oral iron, or were unable to tolerate oral iron or the interval between diagnosis and surgery was short . the anaemia pro-forma was completed . hb was ≤ g/l . they were classified as either having ida or chronic inflammation with ida or anaemia of chronic inflammation hb was measured prior and on average, days following the iv iron infusion. we excluded patients who had their post iv iron follow up blood tests done after surgery. results: this retrospective evaluation included patients. patients were classified as having ida and patients classified as having chronic inflammation with ida. those classified with ida had a mean hb of g/l ( - ), a mean mcv of . fl and a mean serum ferritin of lg/l. those with chronic inflammation with ida had a mean hb of g/l ( - ), a mean mcv of . and a mean serum ferritin of lg/l. follow-up hb was measured on average twenty days post iv iron infusion in both groups. the average hb post iv iron infusion in the ida group was g/l ( - ) with an average increment of g/l and in the group with chronic inflammation with ida the average post iv iron hb was g/l ( - ) with an average increment of g/l. summary/conclusions: in conclusion the group with ida had, on average, a lower starting hb that the group with chronic inflammation with ida and the average increment in hb days post iv iron infusion was greater in the group with ida. however, the group with chronic inflammation with ida cases also responded to iv iron and therefore we strongly consider the use of iv iron in both groups. further studies to evaluate the ongoing effect of iv iron would help assess whether the same level of increment seen with ida can also been seen for the group with chronic inflammation with ida over a longer period and how long the increment was sustained. background: the expansion of personalized genomic medicine has led to the development of targeted therapeutic approaches for patients. one example is sipuleucel-t, an autologous cellular immunotherapy product used to treat prostate cancer manufactured from the patient's white blood cells. this study describes our experience with incorporating autologous cellular immunotherapy products into the workflow of the blood bank. the policies supporting the workflow are outlined and compliance with them is assessed. aims: this study aims to evaluate the process and method used to dispense and track the infusion of sipuleucel-t. methods: this is a retrospective analysis of the dispensation and administration of sipuleucel-t from january -august , which was handled exclusively by the blood bank. standard operating procedures and hospital policies were reviewed and compliance with these policies evaluated. included were patients who had the sipuleucel-t product dispensed and administered. information collected included the total number of products dispensed, patient age, adverse reactions/incidents, premedication, and patient outcome. descriptive statistics were used for data analysis. results: there were products dispensed to patients. the recipients were male patients diagnosed with prostate cancer with a mean age of years. there were doses (a complete course) administered to / ( %) recipients and a partial course ( - doses) administered to / ( %) recipients, for a total of products. the blood bank workflow treated sipuleucel-t as a derivative in the computer system, listing the manufacturer (dendreon corporation) as the supplier. health care providers were instructed to follow the nursing policy for the administration of blood products and derivatives for the infusion of sipuleucel-t. this policy required documentation of the infusion in a transfusion nursing note and reporting adverse events to the blood bank as transfusion reactions. there were no adverse events reported to the blood bank, yet there were adverse events described in provider notes; of them necessitating transfer to the emergency department, and requiring hospital admission. of the infusions, infusions were documented in a chemotherapy note rather than a transfusion note ( %), and ( %) were documented as both a transfusion and a chemotherapy administration. there were additional deviations from the blood product administration policy: cases where the consent check was not performed, case where the product was infused with ringer's lactate rather than normal saline, and cases where the -person -way check erroneously indicated the product was irradiated. summary/conclusions: this study describes one approach to managing cellular therapy products as an extension to existing blood products dispensed by a blood bank. the findings demonstrate noncompliance with hospital policy with this new product as evidenced by failure to report adverse events and failure to follow hospital practices regarding administration. although sipuleucel-t is a product manufactured from an autologous blood product donation, the administration and perceptions of this product may be more similar to a pharmaceutical. as the field of immunotherapies derived from blood product donations continues to expand, these products may necessitate an entirely new approach to ensure proper management. abstract withdrawn. (ref ) . while the mnc procedure is fully automated, cmnc requires frequent interface checks to ensure the collection of the correct cell layer. at the rambam health care campus, a tertiary care center, solely the mnc procedure had been employed till , at which point, the cmnc has been introduced for the use in patients with a white blood cell (wbc) count of ≥ , /ll on the collection day. aims: the current study aimed to compare various parameters of peripheral blood stem cell (pbsc) collection, using the cmnc protocol in allogeneic donors and patients undergoing autologous stem cell (autosc) transplantation. additionally, data on autosc collection using mnc (n = ) and cmnc (n = ) procedures were compared. methods: data were retrospectively obtained from pbsc collection reports in consecutive cmnc procedures, including autologous and allogeneic donors. the following comparisons were made: cmnc results of allogeneic versus autologous donors, a sub-analysis of cmnc results for autologous donors with a pb cd + count ≥ /ll versus allogeneic donors as well as mnc versus cmnc results in autologous donors. the collection efficiency- (ce- ) was defined as the total cd + amount in the collection bag divided by the amount of cd + cells in the pb processed by the collection apparatus. results: in the cmnc, the following parameters significantly differed between autologous and allogeneic donors: mean collection time ( ae and ae min, respectively; p = . ), the total blood volume processed ( . ae . and . ae . , respectively; p = . ) and the final volume in the collection bag ( ae and ae ml; p = . ). the mean ce- in autologous versus allogeneic donors was ae and ae , respectively (p = . ). using cmnc, the collection was effective in % of allogeneic and % of autologous donors. in autologous donors, a significantly lower collection bag volume ( ae and ae , respectively; p < . ) and increased total wbc in the collection bag ( ae versus ae , respectively; p < . ) were obtained using cmnc compared to mnc protocol. thirteen patients were treated with plerixafor due to a low pb cd + count following g-csf therapy; of them achieved a cd count ≥ and their collection was considered effective. summary/conclusions: the cmnc protocol is highly effective in terms of the cell yield in both allogeneic and autologous donors with a pb cd + count ≥ /ll. significantly superior collection results are obtained in allogeneic donors versus autologous ones. cmnc provides a significantly higher wbc and a lower final collection volume than mnc. similar total cd + cell counts are obtained with both methods. . tbv processed ranged from - . tbv with mean of . , average was . tbv for females and . tbv for males mean pre-apheresis cd + count was . cells/ll (range . - . ). mean postapheresis cd + count was . cells/ll ( . - . ). mean cd + cells x / kg recipients body weight was . (range: . - . ). our target yield was ≥ cd + cells/kg body weight of the recipient and in only / ( %) cases, the yield was < . / ( . %) procedures were lvl and / ( . %) were svl. summary/conclusions: most of our pbsc were done for haematological indications ( . %) and the target dose was cells/ll in single leukapheresis. in cases ( %), target yield was achieved, only cases had < but > yield. in our study donors < years have shown to mobilize better than the older children. hematocrit (hct) and weight showed correlation with cd + cell yield but they cannot be taken absolute predictors. wbc count cannot be taken as a predictor for cd yield as high wbc count did not convert into high cd yield or vice versa. high prepheresis cd + count gave higher postpheresis cd + count. large volume leukapheresis (lvl), > tbv gave higher yield as compared to standard volume leukapheresis (svl). blood volume processed related to prepheresis cd + count and/or the weight difference between the donor and recipient. other parameters like hematocrit, wbc count, age etc did not show correlation to the volume processed. in our study, younger age and prepheresis cd + count were found as the most relevant predictors for stem cell yield. background: allogeneic hematopoietic stem cell transplantation is an established therapy for many hematologic disorders. since the discoveries of the potential of peripheral blood stem cells (pbsc) in the hematopoietic reconstitution mid s and early s pbsc gradually replaced bone marrow as the preferred source of stem cells. the introduction of hematopoietic cytokines that can mobilize large number of progenitors into circulation accelerated pbsc usage. aims: the aim of our study is to present our year experience with apheresis collecting of pbsc in donors. methods: this is a retrospective study performed in the institute for transfusion medicine of republic of macedonia and university hematology hospital for period background: obtaining unambiguous results of hla typing plays an important role in the transplantation of hematopoietic stem cells. appropriate selection of alleles in the level of hla between recipients and unrelated bone marrow donors reduces the risk of transplant rejection and graft-versus-host disease. new generation technology ensures the highest possible resolution and obtaining unambiguous genotyping results due to the high complexity of the hla system. currently, this is the selection method for obtaining hla test results at the high resolution level. aims: the aim of this study was to determine hla loci (hla-a, -b, -c, drb / / / , dqb , dpb , dpa , dqa ) in potential bone marrow donors from poland. the research included , potential bone marrow donors registered between and . a novelty of this paper was that the amplification of all hla loci was performed by using multiplex pcr primers in a single tube. that solution completely eliminated the need to pool amplicons. methods: the typing of the hla loci (hla-a, -b, -c, drb / / / , dqb , dpb , dpa , dqa ) of potential bone marrow donors was made by using the alltype tm ngs -loci amplification kit (one lambda). genomic dna was isolated from peripheral blood of , donors. hla genotypes were determined according to the manufacturer's protocol on the miseq illumina platform. the obtained sequencing data was evaluated by using the typestream tm visual ngs analysis software. results: the ngs method allowed to obtaining unambiguous results of genotyping of potential bone marrow donors, and also provided the identification of rare alleles, such as: c* : , c* : , c* : , c* : , drb * : , c* : , b* : , c* : , dqb * : , drb * : , drb * : . summary/conclusions: . new generation sequencing technology (ngs), which is based on pcr, ensures the highest possible resolution. . the ngs method allows to obtain more accurate sequencing results compared to the conventional methods. . the research has confirmed the superiority of the ngs method over conventional methods in obtaining unambiguous hla genotyping results at the high resolution level. background: the accurate results of hla typing are significant for ensuring the success rate of hematopoietic stem cell transplantation. currently, hla typing is mainly based on sanger sequencing, which has a high proportion of ambiguous combination results indicating potential errors for hla typing. it is necessary for finding a more accurate typing method to reduce the risk. next-generation sequencing (ngs) method could provide clonal sequencing of single molecules, which has been used for hla genotyping and improved the scope and precision of hla study. aims: to establish a full-length precision sequencing platform for hla-i gene (hla-a, -b, -c) based on ngs technology and be evaluated by classical sangersequencing method, which can effectively improve the accuracy of hla typing for donor and recipient in hematopoietic stem cell transplantation. methods: hla-i (hla-a, -b, -c) gene-specific primers were screened, and the amplification parameters were optimized to obtain full-length sequences of hla-i gene under the same condition. the sample library for the amplicon was prepared with transngs tn dna library prep kit and the sequencing step was carried out with illumina miseq platform according to the manufacturer' protocol. all the sequencing data in fastq format were analyzed by typestream visual software version . . (one lambda inc.)with the default setting. cord blood samples were collected for hla typing with the mentioned above next-generation sequencing method in our study. in parallel, all the sample were also tested with the sanger sequencing method according to the previous study in our laboratory. results: samples were successfully tested with two methods and the coincidence rate between two sequencing methods was %. with the next-generation sequencing method, the probability of ambiguous results among samples in our study is . %( / ) for hla-a, . % ( / ) for hla-b and % ( / )for hla-c. however, the probability of ambiguous results with the sanger sequencing method is . % for hla-a, . % for hla-b, % for hla-c. summary/conclusions: the full-length precision sequencing platform for hla-i gene (hla-a, -b, -c) based on ngs technology was established, which could greatly reduce the probability of ambiguous results and effectively improve the accuracy of existing hla typing techniques.