key: cord- -jna p p authors: dhakal, parashar; damacharla, praveen; javaid, ahmad y.; vege, hari k.; devabhaktuni, vijay k. title: ivacs: intelligent voice assistant for coronavirus disease (covid- ) self-assessment date: - - journal: nan doi: nan sha: doc_id: cord_uid: jna p p at the time of writing this paper, the world has around eleven million cases of covid- , scientifically known as severe acute respiratory syndrome corona-virus (sars-cov- ). one of the popular critical steps various health organizations are advocating to prevent the spread of this contagious disease is self-assessment of symptoms. multiple organizations have already pioneered mobile and web-based applications for self-assessment of covid- to reduce this global pandemic's spread. we propose an intelligent voice-based assistant for covid- self-assessment (ivacs). this interactive assistant has been built to diagnose the symptoms related to covid- using the guidelines provided by the centers for disease control and prevention (cdc) and the world health organization (who). the empirical testing of the application has been performed with human subjects, all volunteers, using the nasa task load index (tlx), and subjects performance accuracy has been measured. the results indicate that the ivacs is beneficial to users. however, it still needs additional research and development to promote its widespread application. the novel coronavirus (covid- ) was first observed in late in wuhan, china, and the patients suffered from a form of pneumonia [ ] . the virus was identified as genus betacoronavirus, placing it in the same category as the previously discovered deadly viruses such as severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers). the virus has now spread across more than countries. the who declared this virus a global health emergency in early . national emergency was declared in the us in march . more than , people have died from this virus across the globe, with more than , deaths in the us alone as of july , [ ] . hospitals and clinics around the world have been overwhelmed with the cases of covid- . with a lot of panic and rumors, people are visiting clinics and hospitals for other non-related symptoms. these visits are causing increased healthcare costs and spread of infection, while overloading the healthcare system. self-assessment is therefore being studied as one of the solutions to this problem. this technique, i.e. self-assessment, has been used in the field of healthcare for a long time as it helps in learning, functioning more effectively, and fostering self-agency and authority [ ] , [ ] . some recent examples of applications that have been built to self-assess the covid- are [ ] , [ ] . though these applications are beneficial, they might not be accessible to all. moreover, such apps are not useful for someone who does not know how to read, use a computer, or is visually impaired. therefore, in this paper, we propose a novel idea to use the ivacs for self-assessment of the covid- . this interactive application, based on medical condition, helps in more precise clinical decision making about seeking medical care or taking rest at home; without burdening the hospitals at these challenging times. it also educates people with critical information. primary contributions of this proposed work are below: • a new ivacs architecture for the self-assessment of covid- , • a detailed study on the performance of the proposed ivacs, • a study on the performance of the user in cohesion with ivacs, and • a measurement of the perceived mental overload in user due to ivacs. long before covid- pandemic, a wearable healthcare assistant was developed to record contextual and physiological information [ ] . this prototype named lifeminder was used in sensing pulse waves, users actions/postures, capturing contextual photos, and continuous voices. collected data was arxiv: . v [cs.cy] sep sent to a healthcare pc and was retrieved on a web page for user accessibility. some researchers, introduced healthpal, an intelligent dialogue-based personal medical assistant, for self-monitoring of health [ ] . this software was designed to help older citizens in monitoring their health without assistance. researchers also developed an interactive robotic assistant for interacting with patients, measuring vital signs, and recording data [ ] . the robot was interfaced with a blood pressure monitor and had a d face capable of displaying different emotions. their initial study on interaction of patients with the proposed robotic assistant showed the performance improvement of the assistant because of interactivity involved in the task completion when they worked as a team. during early s, most healthcare assistants were focused on the use of wearable devices and computer-based software applications. with the recent advancement of the artificial assistant, researchers have started to explore use of voice technology capable of decision making as a healthcare assistant. some researchers developed patient-focused voice and web services using amazon alexa and google assistant to solve the problem that the patients face using wearable health sensors [ ] . the developed assistant was also capable of making suggestions, scheduling doctor appointments, and reminding the patient before therapy and appointments. other researchers worked on the development of a voice-based assistant using amazon alexa to help medical first responders in the treatment process [ ] . they analyzed the developed assistant performance for a selected emergency treatment scenario where their result showed that the performance of care providers increases with the use of such assistant. all these past assistants were task-specific. in line with the previous works, our ivacs that uses amazon alexa as a voice-based assistant for the selfassessment of covid- based on cdc and who guidelines. fig. shows the overview of proposed ivacs architecture. the architecture is composed of essential layers, namely user interface, communication, and analytical. the user interface layer consists of different hardware devices and components to interact with users such as smartphones, smart speakers, laptops, tablets, smart tvs, and echo, where the input can be in any form such as text input or spoken language. communication layers consist of network and protocols such as smart internet, wi-fi, bluetooth, broadband, and cellular that can be used in connecting the hardware devices from user interface layers to the cloud platform in analytical layers. and the analytical layer consists of two blocks, namely natural language processing (nlp) and decision logic block. the combination of nlp to the decision logic block in the cloud is one of the novel features of our architecture. the process starts with the user requesting the hardware devices in the user interface layer through voice utterance. the request then passes on to the communication layer, and a voice-based input is received by a language processor in the analytical layer. inside the language processor, speech recognition translates the utterance to text. this process is also called speech-to-text (stt) conversion that provides the text output to help the computer in processing the speech command. similarly, semantics processor and context generator blocks help in further processing the text to interpret and understand user commands. afterward, the command is passed to the backend block that contains the developed decision logic. backend also communicates with the database repository to exchange stored information. after processing in the backend, the response is sent to the language processor block again where the text-to-speech (tts) conversion occurs, and the response in the form of speech is sent back to the user. our proposed ivacs was built into amazon web services (aws) and the primary block for our decision logic was developed inside the aws lambda function using node.js. the user can access the proposed ivacs using amazon echo or the amazon alexa application. the information flow for our design in aws has been depicted on the right side of fig. . the process starts by calling the wake word "ask coronavirus," which signals the amazon echo to record the command to alexa voice services (avs). next, alexa skills kit (ask) translates the voice command to text, and if the text matches a predefined utterance then, it calls the corresponding mapped function for that utterance in the lambda function using an intent request. after the execution of the intent, the response is returned to the ask and then to the user. the lambda also communicates with the api gateway that lets us create and access an api. besides, api gateway helps one to interact with the databases and messaging services through a secure gateway [ ] , [ ] . our experiment's main objective was to study the performance of the proposed ivacs and the participants individually and as a team for the self-assessment of covid- . during the experiment, the ivacs will interact with participants and guide them through the process upon knowing their health status. to make the interaction more effective and user-friendly, ivacs has been programmed in a way that it even gives an option of what to answer for each question it asks. in the process of experiment, different parameters such as errors committed by participants and ivacs, the number of interaction between ivacs and participants, the effect of ivacs on participant's performance, and total testing time were measured. in this section, we also presented the cdc and who recommended protocol to follow in the self-assessment of covid- based on which the ivacs decision logic was built. additionally, we discussed the participants' poll and different data collection methods employed to collect various parameters required for performance evaluation. in this section, we discuss the different cases considered in our application and subsequent recommendations made to the users based on their input to the ivacs. as per the cdc and who recommendations, the structure of guidelines that we followed in our application has been depicted in fig. [ ] , [ ] . to provide better recommendations to the user, we divided the different conditions identified till date into three categories: red alert, mild yellow, and safe green. users facing any of the symptoms falling under the red alert category were recommended to call and visit the emergency immediately. similarly, any users facing symptoms listed in the mild yellow were urged not to rush to the hospital and stay home, get in touch with the medical personnel through phone or online applications, and take over-the-counter medication. besides, if the users had recently visited an area heavily impacted with covid- , a large gathering of people, or had been in contact with anyone diagnosed with covid- , they were recommended to stay in quarantine and get in touch with medical personnel through phone or online applications for possible suggestions. finally, if the user does not fall under any of the two categories mentioned above, then they were declared safe and recommended to maintain social distance. the participants for the experiment were the general population with no medical background at all. a total of participants participated in the experiment belonging from different countries such as nepal, the usa, india, and bangladesh. the participants' age involved in this investigation ranged from to years and had an educational background ranging from high school to ph.d. among participants, were male and seven female. for the experiment, we followed the guideline from our previous research publication, where we used the virtual assistant to help medical first responders in the treatment process [ ] . amazon echo, or an alexa application, was used in our experiment for interaction with participants after a comparison of various virtual assistants [ ] . the experiment was carried out by sending the application to each participant. participants were instructed to perform the test in a quiet environment in their homes, where they were monitored over a video call. as part of the experiment, a general -minute briefing of the experiment, testing, and survey was done before starting the experiment. however, none of the participants had any idea about the experiment before actually performing it and were only provided with the word "ask coronavirus" to trigger the ivacs. besides, any chance of the interaction between two fellow participants was forbidden during all stages to avoid human factor bias. the experiment consisted of execution steps with various conditions; however, the total number of execution steps followed by each participant varied on a case by case basis. similarly, testing time could last anywhere between seconds to seconds based on user response to questions asked by ivacs. as depicted in fig. , the process begins with asking about red alert cases and would immediately stop and make a corresponding recommendation if any of the cases are seen. if a participant experiences none of the cases from the red alert zone, then it will move to the mild yellow zone and check for various conditions. finally, if nothing is seen, then the ivacs will enter the safe green zone declaring the patient as safe. during the testing phase, participants got no assistance and were expected to perform alone with ivacs. after the testing process, participants were asked to complete a survey, and the tlx form was used for the procedure. the experimental data such as error committed by participants and ivacs during the testing process, the interaction between ivacs and participants, the effect of ivacs on participant's performance, and average testing time were measured and collected visually through a video call. similarly, parameters such as participant's frustration level, effort, mental demand (md), physical demand (pd), temporal demand (td) as part of the tlx survey, and ivacs's performance such as response time, errors in operation, were collected. these were received using messages and emails from the participants for analysis of cognitive overload of ivacs during task performance. a separate timer was implemented to report the average time taken by participants during the testing process. as mentioned above, the main purpose of this investigation was to assess the performance of the proposed ivacs, along with measuring the effects of human factors on the ivacs. this was achieved through different parameters recorded during the experimental testing process, as mentioned in the data collection sub-section above. to assess the participant's workload during the experiment, we used six parameters of the tlx scale, namely md, pd, td, performance, effort, and frustration. each of these parameters had an exclusive fig. . the nasa task load index (nasa-tlx) ranking presentation self-rating index ranging from to points at a point per division rate. to assign self-rating points, the post-testing questionnaire was adopted as a user validation process. the overall workload was determined using equation ( ) that provided a normalization. n asa t lx score (overall workload score) = − (m d + p d + t d + p erf ormance + ef f ort + f rustration ) ( ) fig. shows the tlx ranking presentation where each parameter varied on a scale of to during the user survey. it shows the overall performance of participants using the tlx score, which has a range of - to where is the best performance, and any negative value was considered as a failed performance with the number of errors encountered during testing. we observed that many participants didn't feel any mental workload, or were overwhelmed by td. however, some participants clearly showed frustration as they had to repeat some of the voice commands because of their diverse background and the accents of english they possessed. our ivacs's nlp system also had a limitation in understating various dialects which we believe is one of the main reasons for some participants facing errors/ repetition in steps during self-diagnosis. to evaluate the performance of both ivacs and table i . to elaborate more, a mean execution step value of and mode and median as , implies most of the participants for our experiment belonged to the safe green zone. in contrast, some belonged to the mild yellow zone. similarly, a mean of seconds and mode and median of seconds indicates that some of the participants struggled in communication with ivacs and had to repeat speech utterance a couple of times to move to the next step. besides, the mean error value was found to be . and the median and mode error values were zero, which signifies that there was some anomaly during the experiment, where for most of the participants, the ivacs worked well. however, some faced errors during the experiment, which increased the mean value. this error was noticed mostly seen among the non-native english speakers. in essence, ivacs showed different results for some of the participants while it was uniform for most of them. besides, item characteristic curve (icc) was also used on a probabilistic scale to understand the relation between the expected performance versus the participant's actual performance for the given task (θ). fig. depicts the performance of participants during the experiment as compared to their expected performance based on the ability to perform on a probabilistic scale. it was observed for some participants' that the performance was slightly lower than the expected performance based on their ability (θ). various parameters might have caused this since, no formal training was required for this experimental testing and all the participants who took part in the experiment possessed the necessary skills to complete the given task. our analysis of results and tests indicates the primary reason for some of the participants' lower performance during the experiment was due to different pronunciations and accents they possessed, which made it hard for the nlp system to recognize their speech utterance, resulting in an error/repetition during the experiment. in this paper, we presented a novel real-time ivacs architecture for the self-assessment of covid- . the architecture was built inside aws following the cdc and who guide-lines. besides, we also performed the empirical testing of the proposed architecture with volunteers where we studied the performance accuracy of a proposed ivacs, the performance of the user in cohesion with ivacs, and the perceived mental overload in the user due to ivacs. the study of the perceived mental overload in users due to ivacs was done through the survey using the tlx form. as future work, we would like to include more volunteers for the experiment and study the response time of the proposed ivacs. besides, we would also like to work on the performance improvement of ivacs and bring down the mean error value even for non-native speakers. st known case of coronavirus traced back to november in china countries where coronavirus has spread daily assessment of rheumatoid arthritis disease activity using a smartphone application: development and -month feasibility study a simple self-report health assessment questionnaire to identify oral diseases coronavirus self-assessment coronavirus (covid- ) self-assessment lifeminder: an evidence-based wearable healthcare assistant healthpal: an intelligent personal medical assistant for supporting the self-monitoring of healthcare in the ageing society designing a robotic assistant for healthcare applications interactive home healthcare system with integrated voice assistant effects of voicebased synthetic assistant on performance of emergency care provider in training natural-language voiceactivated personal assistant talk to me: exploring user interactions with the amazon alexa coronavirus disease (covid- ) symptoms novel architectures for human voice and environmental sound recognition using machine learning algorithms key: cord- -xols h authors: jenkins, g. trey; shafer, michael s.; janich, nicole title: critical issues in leadership development for peer support specialists date: - - journal: community ment health j doi: . /s - - - sha: doc_id: cord_uid: xols h this paper is a qualitative analysis of perspectives on leadership development among working peer support specialists and highlights the challenges, needs and efficacy these individuals experience in their work settings. six participants engaged in a h semi-structured focus group. participants were guided through a series of nine questions regarding their transition to leadership, professional communication and relationships. seven themes emerged: managing dual relationships; having difficult conversations; push and pull of leadership; taking responsibility for others; taking responsibility for self-care; addressing stigma in the workplace, and, spirituality/a calling to help. these professionals integrate their personal experiences of recovery into their direct care and leadership approaches in the workplace. this blending of recovery concepts and supervision approaches reflect some of the powerful elements that peer recovery specialists are uniquely qualified to lead in the healthcare workforce. these findings provide important implications for leadership development among this growing segment of the healthcare workforce. recovery-oriented services are becoming increasingly common in behavioral healthcare, particularly for individuals with serious mental illness (smi) and co-occurring substance use disorders (chinman et al. ; gates and akabas ) . a recovery-orientation promotes whole health and focuses on self-directed care as individuals integrate into their communities (gates and akabas ) . a recoveryorientation has prompted the rise of peer support as a core practice in behavioral healthcare (chinman et al. ; daniels et al. ; gates and akabas ) . many terms are used to describe individuals who provide peer support; this manuscript will use peer support specialists (pss). peer support is different from other forms of help provided by traditional behavioral health workers (repper and carter ) . peer support is a form of mutual aid provided by individuals, often certified, although not licensed, who are in recovery from mental illness and/or substance use. peer support is based on mutuality, empowerment, hope and advocacy, and can be provided throughout treatment to facilitate long-term recovery and resiliency (chinman et al. ; gates and akabas ) . it involves giving and receiving help based on a shared understanding of what is helpful between people in similar situations (soloman ; mead et al. ) . respect, reciprocal relationships, empowerment, and shared responsibility are important concepts and practices in peer support (repper and carter ) . pss use their lived experiences-not professional expertise-to help individuals manage their mental illness, engage in treatment, and establish a fulfilling life (chinman et al. ) . pss are uniquely positioned to instill hope through self-disclosure, to model self-care of mental illness, and to develop relationships based on trust, acceptance, and empathy (davidson et al. ; repper and carter ) . research has shown that, when compared to traditional behavioral health services, people who engage in peer support, experience improved outcomes across various areas of health and wellbeing (davidson et al. ; chinman et al. ; gates and akabas ; hutchinson et al. ; repper and carter ) . it is estimated that there are over , pss working in the u.s. approximately states have certified peer programs with the average pss making $ per hour (kaufman et al. ; daniels et al. ) . pss work in a variety of settings including inpatient and outpatient facilities, day treatment programs, hospice, respite, rehabilitation centers, and government organizations (chinman et al. ) . pss can serve in a variety of roles, such as advocacy, navigation, outreach, case management, developing and facilitating treatment services/activities, mentoring, supervision, training, administration, and education (salzer et al. ) . pss can also serve in a variety of settings including emergency rooms, hospitals, jails, prisons, state psychiatric hospitals (cronise et al. ; salzer et al. , migdole et al. . a peer-run is a program that unlike traditional treatment models, is more focused on socialization, self-directed support, empowerment and hope (swarbrick et al. ). individuals engaged in the profession of peer support have been shown to benefit from the experience in terms of enhanced self-esteem, empowerment, hope, coping skills, and community integration (gates and akabas ; hutchinson et al. ; repper and carter ) . pss also benefit from increased income, increased sense of self-efficacy, and opportunities for skill development, socio-economic mobility, and career advancement (gates and akabas ; hutchinson et al. ; repper and carter ) . self-efficacy is an important element in successful leadership. it is the perception that one is capable to meet the demands of a specific task (mccormick et al. ) . it is this concept that influences leadership behaviors such as goal setting, decision-making, and problem solving. literature on selfefficacy has demonstrated the causal relationship between self-efficacy and leadership success. agency leadership has a great deal of influence in developing an individual's selfefficacy. agency leaders can support increased self-efficacy by giving their supervisory staff challenging opportunities, modeling successful skills and strategies, and providing thoughtful feedback and encouragement (mccormick et al. ) . as integrated care becomes more prevalent and medicaid reimbursements expand, pss roles are expected to grow as well (myrick and del vecchio ; tucker et al. ; swarbrick et al. ; ; peers for progress ) . a challenge will be the professional development and career advancement opportunities available to pss workers that allow them to expand their role, including leadership, while not diminishing the value of lived experience of recovery (cronise et al ) . to date, little research has been reported on the leadership development of peer support specialists. anecdotal evidence suggests that there are many peers already working in leadership and supervisory roles today (inaps ; daniels et al ) . there is a growing need to address leadership and supervision within the peer workforce in general, and more specifically, addressing the motivations and self-efficacy in peer leadership development. in this study, we explore some critical elements necessary for pss career development and the transition to leadership. this is explored at both the intrapersonal (transition from client to peer and peer to leader) and the inter-personal (professional relationships and communication) level. a convenience sample comprised of six ( ) pss were recruited from a pool of thirteen ( ) participants in a university-sponsored peer support specialist leadership development program. six ( ) individuals chose not to participate in the focus group and one ( ) individual dropped out of the program prior to focus group recruitment. the participants were invited to attend a statewide behavioral health conference where they presented their culminating project, attended a graduation for the leadership program, and participated in the focus group. the group included three female and three male participants. all but one of the participants currently works in a supervisory capacity. all but one participant are employed by a peer-run agency. one of the participants is in a leadership role, but has no direct supervisory responsibilities. the focus group was held in a small conference room where a university-sponsored behavioral health conference was occurring. data was collected during a two-hour session that was facilitated by two researchers. the semi-structured focus group followed a protocol that provided narrative for facilitators to follow and guided participants through a series of questions and discussion topics (see appendix). the session was audio-recorded and transcribed for analysis. drawing upon the foundations of mutual aid (bergart ; waskey ) , recovery (borkman et al. ; kaskutas et al. ) , and workforce development (holland ; jacobs and hawley ) , questions developed by the researchers were informed by the interpersonal and intrapersonal circumstances in leadership development. participants were asked a variety of questions regarding their motivations to become a pss, their transition to leadership (e.g. barriers, strengths, challenges), and professional relationships and communication (e.g. who initiated the transition into a leadership role? how have things changed?). the data was managed, coded, and analyzed using nvivo pro version . themes were derived using an iterative approach in which coding was guided by theory, literature, and concepts that emerged naturally (tracy ) . we identified seven common themes defined in table . the study was approved by arizona state university's institutional review board. participants described a number of internal and external factors that were associated with their movement into a leadership/supervisory role. we defined the "push and pull" of leadership as: push-the expressions of internal or personal drive and desire to lead, to advance in one's career, and confidence in one's leadership potential. pull-the expression of being recruited, targeted, encouraged or fast tracked into a leadership role. for example, balancing one's personal recovery and personal drive was described by one participant as: i can say a few times, i was approached and offered the keys and i said, 'no, i don't think i'm ready for that yet.' i was in transition… there was a lot of programming, and parenting classes and things like that… .i didn't want that responsibility at that time. it was ….i was like, 'yeah, i think i'm ready.' they offered me the keys again. i was like, 'okay'. another participant described the pull from an employer who had faith in them, their recovery, and their abilities: "a lot of people had faith in me, and they were other people in recovery, and-they held the hope for me when i couldn't have the hope for myself maybe." another participant described the push as: "that i'm capable, for me. capable of being in a supervisory role and being successful in it." as part of the transition process, participants discussed the dynamics and challenges of going from co-worker/friend to leader/supervisor in their organization. participants discussed the degree of distance they maintain with colleagues who are also peers in recovery. some maintained close friendships, while others distanced themselves. one participant shared, "i'm very picky on who i really truly allow into my life and stuff like that because a lot of coworkers, they're peers, but they [are not] trying to do the same thing that i'm trying to do." the challenges of establishing appropriate workplace boundaries was characterized by another participant: "it's like, we can-like at lunch, we can talk about our families and stuff like that, but when we're at work and when we're in our supervisions and things like that, it's all about work. that's a challenge." another participant described the deterioration of a relationship with their "best friend in recovery": "i'm still me. i'm just in a different role. i'm still peer support first, period. you had asked what's the relationship like now. it's nonexistent….we never talk anymore." another theme that emerged from the participants' transcript was having difficult conversations. we defined this as comments that conveyed an ability to be assertive, give direction, listen with empathy, and provide constructive criticism. some experienced challenges in assertiveness, and others struggled with giving direction. for example, "i think communication is huge. that is something i've struggled with; having difficult conversations…, sometimes being assertive, standing up for what i believe in." they went on to say: table definition of themes push-the expressions internal or personal drive and desire to lead, to advance in one's career, and confidence in one's leadership potential. pull -the expression of being recruited, targeted, encouraged or fast tracked into a leadership role managing dual relationships balancing the dynamics and challenges of going from co-worker/friend to leader in their organization. appropriate peer and supervisor relationships with former co-workers/friends and the impact on recovery relationships having difficult conversations the ability to be assertive and give direction, listening with empathy, and constructive criticism taking responsibility for others expressions of responsibility for mentoring, supporting, coaching or modeling for staff and co-workers taking responsibility for self-care activities that aim to reduce compassion fatigue and burnout. the balance of professionalism and addressing stigma in the workplace addressing stigma experiencing bias and/or advocating against bias. modeling what it means to be a peer professional spirituality/a calling to help reference to higher power, god, spirituality, which often intersects with religiosity and/or intersecting with a calling to help or become a pss i'll let somebody keep making the same mistake because i won't say anything. they shoot the messenger, right? who am i to tell them how to do it if they want to keep doing it the wrong way? i should. deep down inside, i know i should. i just don't want the pushback, so i just don't say anything. participants also described difficulty in providing constructive criticism. "i've never seen an organization of workers where you say one thing, and it messes up their whole day, and they want to go home." another participant described using what they called "praise-polish-praise," or more commonly known as a praise sandwich, a concept learned in their initial peer support certification training (st. george ). they went on to describe the praise method of communicating; "for me, i would rather a peer tell me, 'hey, i'm noticing this. what's that about?' because then… i'm not receiving it as a, you screwed up kind of thing". another participant went on to discuss the challenge of active listening and expressing empathy when communicating. learning to listen and being empathetic no matter what. that's been the biggest one for me [because] sometimes you do have the right answer for them…, but that's not what they really need to be hearing. they just need to be heard…. with regard to difficult conversations, we asked a follow up question about strengths and challenges communicating with peers versus non-peers at work. one person shared their thoughts on talking with non-peers: for me, it's been nice because i don't always have to talk recovery. i can just have a normal conversation, which in recovery, is normal conversation for me, but always talking about mental health or always talking about substance use….i can actually talk about something else now, too. conversely, another participant, who works at a consumer operated service program, described the ability to talk openly about their recovery and how healing it was to be open about their diagnosis and work with other peers: the reason why i like working for…is because i don't have to deal with that….i kept a secret for so long at a company that i didn't want them to know, and all it did was hurt me….i don't want to go down that path again. taking responsibility for others was another theme that emerged from the transcript and included expressions of responsibility for mentoring, supporting, coaching, or modeling for staff and co-workers. one participant characterized the responsibility as: "you guide, but you can't do it for them." participants recounted instances where they offered coaching that promoted self-sufficiency and empowered staff. unique to peer supervision, is supporting staff's recovery as it relates to their profession and role. this is a delicate balance of supportive supervision and empowering the pss, while not becoming the "therapist or sponsor". one participant described their feelings of working with a staff member who experienced a relapse: when they don't understand, why does this keep happening to me? it's like, [because] you're still high. you want to tell them like that, but you can't-they have the answers themselves, so you can't really tell them. you can. you do tell them, but you don't really-you have to tell them in a way that they get it for themselves. self-care was a common topic of conversation among these participants. the self-reflection and self-awareness of pss regarding their own self-care is a unique asset of this workforce. for many, self-care is important to sustaining recovery, especially as responsibilities increase. one participant described the experience of how they took control of their depression symptoms: … for me, it was depression….i can allow that to get out of control if i allow it to, but i'm able to now recognize and try to not take my work home with me and really focus more on taking care of myself when i'm not actually at work. another participant reflected on self-care, and how it helped them prepare to lead. "having new responsibilities, i realized, i need to get a full night's sleep. i need to actually exercise again and get in the right mindset for this." in addition to sleep, meditation was a frequently identified self-care tool: the other thing is the meditation part. i know how important meditation is. i really do. i need that quiet time. now, i'm actually doing the meditation. i'm actually doing it. more formalized as opposed to just sitting in the corner and reading my affirmations, the breathing exercises. it really helps. one participant described incorporating meditation into her leadership and supervision strategies: i started doing a meditation for my staff. i just put it on my phone, and it was like at : . that's it. we're locking the door. we're gonna put a note up. if you want to participate, great. if you don't, that's great too. commonly addressed in peer support is stigma and the role peers have in advocating for others with mental illness and on behalf of themselves as peer professionals. stigma in the workplace can be a huge stressor; part of caring for self is to address stigma in a manner that fits the individual. in a follow up question, participants shared how they addressed stigma in their respective agencies. participants described their experience as either witnessing bias (personally or secondary) and/or advocating against bias. one participant shared their experience of witnessing co-workers talk negatively about a fellow peer: we had another-a peer, an admin, and just she was going through a hard time in her recovery. she was having some struggles. just to hear some of the ways that other people would talk about her and being a peer, i felt this, 'i got to stick up for her.' you know what i mean? it sucked because you see this side of people, and you're like, don't you have any empathy? haven't you been through some hard times? maybe you don't talk about it, and maybe you're not as open to sharing about it with other people, but it's like, it's hard to see that. they went on to say that they felt challenged to "step up" and advocate, but they felt a responsibility to not only advocate for this one individual, but to "help promote what a peer is really [and] how recovery is…normal." another participant described their feelings about advocacy in the workplace as a peer professional: that was a growing experience because i figured out that i'm still able to advocate and still remain professional, and at the same time, i didn't care about what that person thought about me later because it's like, as a peer, if i'm not doing that, then i'm adding to the stigma, or i'm-not adding to it, but i'm not contributing to stopping it either. for many of the participants, their spirituality is a foundational element of their recovery and one which fuels the passion for their work. for those individuals in recovery that have participated in some form of -step group (alcoholics anonymous, narcotics anonymous), the th step's call to service provides a spiritual basis for their work in the recovery field. "having had a spiritual awakening as a result of these steps, we tried to carry this message to alcoholics and to practice these principles in all of our affairs" (alcoholics anonymous ). as one participant described a common expression among pss: "i fell into it, but deep down inside, i've always known that i wanted a job helping others that are recovering from substance abuse ever since i went into treatment." for others, their early recovery experiences were religious-based and involved an intentional decision to convert: "when i first got into recovery about five and a half years ago, i got saved. i'm all about god and church and stuff like that." another participant characterized their leadership as divinely inspired: "my higher power, which is god and jesus christ….i realized at that point in time that everything that i'd done in the past was preparing me for this position." the purpose of this study was to identify common experiences of pss who have advanced in their career to a supervisory or managerial role. a focus group of six pss working in managerial/supervisory roles in outpatient behavioral health agencies was conducted with the resulting audio recording transcribed and qualitatively analyzed. seven recurring themes emerged that characterized some of the experiences and resulting insights these individuals disclosed. these themes provide insight for the leadership development of pss, along with implications for health care agency peer support program development. before exploring the effects of these findings, we acknowledge the significant limitations of our methods and the resulting limitations to the external validity of these findings. the small sample size and single sample is a significant limiting factor. in spite of this limitation, the results provide some tentative observations that may advance the research and development of this unique and growing segment of the healthcare workforce. these findings provide support for agencies that are employing pss and/or responsible for the cultivation of professional and leadership development. our findings suggest that communication in general, and effective management of difficult conversations in particular, may be areas for training and development in pss managers, and other staff as well. the participants of this focus group discussed the importance of having direct and 'difficult' conversations with staff while at the same time, expressing a range of efficacy in doing so. for these participants, personal experiences in receiving and providing direct communication to others often creates an awareness of the importance of such communication. experience in group therapy, individual therapy, and wellstructured -step meetings provide unique but consistent exposure to direct communication, often about one's own shortcomings, sobriety status, symptom status, and substance use. as such, these emerging leaders may have a sense of comfort in these sorts of communications. providing these emerging leaders with learning opportunities about how to have direct workplace communications may be a practice agencies should consider. another practice implication for agencies is the value in addressing the challenges and strategies of managing dual relationships with their former co-workers and/or "recovery buddy". dual relationships, where the peer professional has more than one relationship with clients or colleagues (reamer ) , are something the peer leader will inevitably have to manage. for the individual, they may decide to maintain their friendships, and for others it is important to impose a personal policy of no friendships in the workplace. what is important is that new leaders have the ability to discern when to be supportive, and when to refer their staff to outside support. it is a delicate balance when trying to maintain the essence of peer support and mutuality. agencies developing pss leaders may wish to consider creating opportunities for emerging leaders to have on-going conversations around supervision and boundaries. within larger agencies, physically re-assigning leaders to new locations where they have not previously worked as a pss may be an option to consider in certain circumstances. additionally, peer supervisors are important for early career peer professionals and peer support teams who need guidance and mentorship through the lens of peer support and recovery principles. managing dual relationships is not unique to pss leaders, it has been noted as a leadership concern and consideration among non-pss emerging leaders as well (reamer ) . the individuals that participated in this study expressed a range of strategies and approaches they take in managing these relationships in an effective, recovery-informed approach. once again, the lived experience of recovery that these individuals have shared often leads to a greater sense of self and self-awareness. this sense of self, often a focus of therapeutic interventions, results in individuals developing greater clarity in their interpersonal boundaries. the participants described the importance of self-care and their responsibility to use self-care to be a better leader. participants described the need to get a good night's sleep, eat well, and create a wellness routine that supports their own recovery and leadership capability. one participant described their efficacy in taking control of their symptoms in order to meet the demand of their increased responsibilities. the lived experience of pss may uniquely prepare them to be "organizational champions" (valente ) within an agency looking to stimulate workplace wellness initiatives among their staff. one of the more unique aspects of employees with lived experience is a robust presence of spirituality that the employee assigns as their reason for working as a pss. as noted by deegan ( ) , recovery from mental illness is in part a spiritual experience. for individuals exposed to -step recovery programs, spirituality and a calling to help are central themes and concepts. culminating with the th and th step acknowledgement of a 'spiritual awakening', and a commitment to spread the word of recovery, becomes a call to action for many individuals to enter helping professions such as peer support. this spiritual element has important practice implications for both pss leaders but also agencies developing pss leaders. for leaders, developing a spiritual foundation is an intrapersonal exploration that can enhance emotional intelligence (bracket et al. ; serrat ) which are an important set of soft skills that are highly coveted in today's leaders. incorporating a spiritual foundation while transitioning to a leadership role, is a critical time that may be supported by supervisors and mentors of emerging pss leaders. in particular, pss may need structed time to discuss how to incorporate spirituality as a foundation to their values, beliefs, and sense of self, without bringing spirituality/religion as a primary feature in their professional role. as noted, these findings are limited by our methodology and sample size. nonetheless, we believe that the concepts that emerged from this focus group provide a framework that will contribute to future research on peer leadership development in the healthcare workforce. the recent release of practice-guidelines for peer specialists and supervisors by the the international association of peer supporters (inaps ) provides a framework for peer specialist-supervisors, closely aligning with some of the peer leadership qualities addressed by the current study. future research should elaborate upon the 'hard skills' or technical-administrative skills and competencies that emerging peer supporter leaders are called upon to develop (zimmerman-oster and burkhardt ). skills such as reading financial ledgers, budgeting, project management, proposal development, and data driven decision-making are a few of the universal leadership skills that emerging pss leaders may need to acquire. future research should assess the competency and efficacy of pss leaders in these technical areas. integrating high priority skill training into existing pss academies and other educational opportunities for pss workers could advance the development and achievement of this segment of the workforce. further research on emerging pss leaders should more deeply explore the experiences of workplace stigma and discrimination. although stigma was not a major theme among these participants, it lingered below the surface and may have been minimized by the over-representation of peerrun agency based participants in this study. future research should also draw upon larger and more representative samples of emerging pss leaders, particularly those who are employed in hospitals, outpatient healthcare and/or behavioral healthcare agencies. in these agencies, managed by and staffed predominately by non-pss staff, anecdotal reports of bias and stigma by pss employees are not uncommon and undocumented. research that more accurately assesses the prevalence of workplace stigma and identifies organizational strategies that reduce or eliminate stigma, is critical to the continuing development of the peer workforce. first off, congratulations on completing the leadership and supervision course and thank you all for participating in today's focus group. my name is trey jenkins and this is nicole janich. we will be facilitating today's discussion. to learn more about your individual experiences working as a peer in a leadership role. additionally, there is a gap in research regarding peers in leadership and it is our goal to write and publish a paper based on your experiences in the course and today's discussion. during the activity, we are going to ask a number of questions designed to get a picture of your experiences working as a peer in leadership. we will ask questions in two broad categories including, intrapersonal (self/internal) and interpersonal (relationships with colleagues and staff both peer and non-peer), feel free to share your thoughts and feelings openly. all results and future discussion will be anonymized. please know that there is no right or wrong answers to any questions. we are interested in your honest experiences and opinions. our session will be audio-recorded so that we can go back and listen to them later. please speak one at a time and think about the recording and me taking notes as simply an extension of my memory. if you are uncomfortable being recorded, you may leave the room at any time. we will keep your comments confidential and your names will not be associated with any reports. we have a series of questions. we will ask a question to prompt a discussion, invite you all to discuss, and ask follow up questions if necessary. we invite you to talk with each other. sometimes, i may jump back into the conversation and direct it to go another way. today, we have scheduled two hours for the discussion. we may or may not use the entire amount. are there any questions before we begin? to get started we would like to begin with everyone introducing themselves and tell us how many years you have been working as a pss and when you transitioned to a leadership role. by leadership role, we generally think of someone who is supervising or guiding other individuals and/or making decisions or contributing to the decision making process for an organization or program. how many of you are working in a leadership role such as that which i just described? transition from peer to leader: next, we would like each of you to please describe your personal experience in peer support. . people become interested in working as peer support specialists for a variety of reasons and motives. tell me about some of the reasons or motives that each of you had that lead you into this line of work. a. had you worked in a helping profession before becoming a peer support specialist? b. how long did you work as a peer support specialist? . in order to participate in the leadership course, each of you had to document that you are currently, or are about to be promoted into a leadership role within your agency. tell me about the circumstances under which you transitioned from a worker role to a leadership role? a. had you sought this out, or did someone in the company approach you? professional relationships and communication: moving into a leadership role often brings about changes in how we relate to others, including our partners, family members, coworkers, and others in leadership positions. i want to turn our attention now to your interpersonal interactions, both inside and outside of the workplace. . sometimes when we get promoted into a leadership role, we find ourselves now supervising or directing the work of former coworkers. by a show of hands, how many of you have or are now supervising people who used to be your coworkers? a. what was that experience like for you during the first few months after your promotion? b. how would you describe the nature of those relationships now? c. what did you and your former coworkers do to improve these types of relationships, or what would you recommend other do who find themselves in these situations? . when we get promoted into a leadership position, we find ourselves developing a whole new set of peer relationships, or adjusting the nature of our relationships with other individuals who are also in a leadership role. by a show of hands, how many of you have had to develop relationships with new coworkers or supervisors as a result of your promotion? by a show of hands, how many of you find yourself working now with coworkers who are not in recovery? exclusively (all coworkers not in recovery?) (all coworkers in recovery?) (a mix of coworkers?) a. what was that experience like for you during the first few months after your promotion? b. how would you describe the nature of those relationships now? c. what did you and your new set of coworkers or supervisors do to improve these types of relationships, or what would you recommend to others who find themselves in these situations? d. how has your former status as a peer support specialist (or knowledge of recovery status) affected these relationships? i. do you feel that you are treated differently because your coworkers know you are in recovery? ii. describe the nature of that different treatment? . probe: coddled? excluded from meetings, discussions, decision making opportunities? treated with "kid gloves"? performance expectations that were less than or more than others? disrespected? iii. what did you and your former coworkers do to improve these types of relationships, or what would you recommend others do who find themselves in these situations? e. how would you compare the nature and quality of the relationships you have with your coworkers who are also in positions of leadership, as compared with your coworkers when you were a peer support specialist? i. probe: more professional; less personal; more task oriented; more guarded; less supportive . thinking only about the interpersonal interactions you have with your former and your current coworkers and supervisors, what are some of the challenges and barriers that you experienced as you transitioned into this new role? thank you all for participating in our discussion today. if you have any questions regarding the focus group that we did not cover today, please contact us by email or phone (facilitators provide their business cards to participants). the story of how many thousands of men and women have recovered from alcoholism introduction to part two: what is a group, and what is social work with groups? developing an experiential definition of recovery: participatory research with recovering substance abusers from multiple pathways emotional intelligence: implications for personal, social, academic, and workplace success: emotional intelligence. social and personality psychology compass peer support services for individuals with serious mental illnesses: assessing the evidence the peer support workforce: results of a national survey national survey of compensation among peer support specialists. the college for behavioral health leadership peer support among persons with severe mental illnesses: a review of evidence and experience spiritual lessons in recovery developing strategies to integrate peer providers into the staff of mental health agencies. administrative policy in mental health and mental health services research a workforce development systems model for unemployed job seekers the personal and vocational impact of training and employing people with psychiatric disabilities as providers recovery definitions: do they change? drug and alcohol dependence peer specialist training and certification programs: a national overview. texas institute for excellence in mental health extending self-efficacy to leadership: a review and empirical test peer support: a theoretical perspective exploring new frontiers: recovery oriented peer support programming in a psychiatric ed peer support services in the behavioral health workforce: state of the field the affordable care act and peer support boundary issues in social work: managing dual relationships a review of the literature on peer support in mental health services certified peer specialist roles and activities: results from a national survey understanding and developing emotional intelligence peer support/peer provided services underlying processes, benefits, and critical ingredients th edition peer employment training: a certified peer support/ recovery support specialist training. ri international consumeroperated self-help centers: environment, empowerment, and satisfaction wellness coaching: a new role for peers qualitative research methods: collecting evidence, crafting analysis, communicating impact supervisor guide: peer support and whole health and wellness coach identifying opinion leaders to promote behavior change. health education & behavior mutual aid. encyclopedia of environment and society leadership in the making: impact and insights from leadership development programs in u.s. colleges and universities. executive summary. kellogg foundation key: cord- -ec rkxdn authors: chun, audrey; levy, isaiah; yang, ajax; delgado, andrew; tsai, chung-ying; leung, eric; taylor, kristell; kolakowsky-hayner, stephanie; huang, vincent; escalon, miguel; bryce, thomas n. title: treatment of at-level spinal cord injury pain with botulinum toxin a date: - - journal: spinal cord ser cases doi: . /s - - - sha: doc_id: cord_uid: ec rkxdn study design: randomized, double-blinded, placebo-controlled, cross-over study. objective: to explore whether botulinum toxin a (bonta) could be effective for treating at-level spinal cord injury (sci) pain. setting: outpatient sci clinic, new york, usa. methods: participants were randomized to receive subcutaneous injections of either placebo or bonta with follow-up (office visit, telephone, or e-mail) at , , , and weeks to assess the magnitude of pain relief post injection. crossover of participants was then performed. those who received placebo received bonta, and vice versa, with follow-up at , , , and weeks. results: eight participants completed at least one of the two crossover study arms. four completed both arms. the median age of the eight participants was years (range – years) and % were male. all had traumatic, t -l level, complete sci. although our data did not meet statistical significance, we noted a higher proportion of participants reporting a marked change in average pain intensity from baseline to and weeks post-bonta vs. post-placebo ( % vs. %). at and weeks post-bonta, almost all participants reported some degree of reduced pain, while the same was not seen post-placebo ( % vs. %). conclusion: the subcutaneous injection of bonta may be a feasible approach for the control of at-level sci pain and is worthy of further study. sponsorship: the onabotulinumtoxina (botox) used in this study was provided by allergan (irvine, ca). at-level spinal cord injury (sci) pain is neuropathic pain perceived at the neurological level of injury (nli) or within three levels below the nli and is thought to be a result of damage to the spinal cord or its nerve roots [ ] . it has been reported to occur in approximately one third of individuals with sci [ , ] . various pharmacological agents used for treating at-level sci pain have been shown to have only limited efficacy at best [ , ] . therefore, a significant need for the investigation of potential new treatments for at-level sci pain remains. botulinum toxin a (bonta) is a neurotoxin protein produced by the bacterium clostridium botulinum. it acts at the neuromuscular junction and its onset of action occurs within - h after administration, with peak clinical effect occurring - weeks after administration, then - months of effect duration [ ] . at the level of peripheral nerves, bonta may inhibit the synaptic release of local neuropeptides associated with pain transmission, such as glutamate, substance p, and calcitonin gene-related peptide [ ] . at the level of the central nervous system, retrograde effects of bonta on the spinal cord via axonal transport have been proposed [ , ] . bonta therapy has so far been shown to have some effectiveness in treating various peripherally mediated neuropathic pains, but the literature on bonta remains limited for treating centrally mediated pain [ ] . to date, one randomized, double-blinded, placebo-controlled study has successfully been able to demonstrate that subcutaneous bonta may reduce neuropathic pain in persons with sci. this study by han et al. evaluated patients with neuropathic pain associated with sci, both at-level (n = ) and below-level (n = ), and found participants demonstrated significantly reduced pain at and weeks after bonta injections compared with after placebo with saline. they also showed a marginal trend towards improvements on the physical health domain of the world health organization quality of life instrument (whoqol-bref abbreviated form) at weeks post-bonta vs. post-placebo [ ] . bonta has been shown to have a favorable safety and tolerability profile across a broad spectrum of therapeutic uses [ , ] . adverse effects (aes) associated with bonta are generally related to the mechanism of action of the toxin (e.g., dose-dependent focal weakness when injected intramuscularly). other local side effects include temporary injection associated pain, edema, erythema, ecchymosis, headache, and short-term hyperesthesia. systemic side effects include nausea, fatigue, malaise, rash, and flu-like symptoms [ ] . in summary, a significant percentage of persons with sci report at-level sci pain but there is a lack of effective treatment to date, and bonta has shown preliminary evidence of effectiveness for neuropathic pain after sci in one clinical trial while having a favorable safety and tolerability profile. our study sought to further explore whether the subcutaneous injection of bonta could be a feasible approach for the control of at-level sci pain. this study was designed as a randomized, double-blinded, placebo-controlled, crossover study. institutional review board approval (irb # - ) was obtained prior to conducting any study related procedures and informed consent was obtained from each participant. participants received a subcutaneous injection of either normal saline (placebo) or bonta with follow-up (via office visit, telephone, or e-mail) at , , , and weeks post injection (phase , p ). crossover of participants was then performed. those who received placebo received bonta, and vice versa, with follow-up at , , , and weeks (phase , p ). twelve weeks were determined as being the minimum required wash-out period based on the pharmacokinetics of bonta [ ] . participants were given the choice to start the p course at the time of -week follow-up for p , or to defer the p course until a later time point. all study activities took place in a large tertiary care hospital in the outpatient sci rehabilitation clinic setting. portions of this study have been accepted for poster presentation at the american congress of rehabilitation medicine annual conference [ ] . participants were recruited via newsletter advertisements, physician recommendations, and clinicaltrials.gov (nct # ) between and . participants were included if they reported chronic traumatic sci (duration > months) and pain that has been: ( ) present continuously for ≥ month, ( ) of at least moderate average intensity over the prior week (numeric pain rating scale [nprs] score ≥ / ) and ( ) diagnosed by an sci provider as being at-level sci pain with a high degree of certainty [ ] . they were excluded if they were: ( ) < years old, ( ) pregnant, ( ) with any contraindications to bonta (e.g., neuromuscular junction disease), ( ) with a history of intolerance, hypersensitivity, or allergy to bonta, its preservatives, or the ethyl chloride used as an analgesic during injections, ( ) with a history of bonta injections within the past months, ( ) with a history of coagulation disorder or current infection, ( ) with insufficient command of english, and ( ) unable to provide informed consent. consented participants underwent a pre-procedure evaluation, consisting of a focused history and physical exam, by a physician blinded to whether they would be bonta or placebo recipients. each participant was asked to localize his or her area of worst pain, then to describe and rate the intensity of his or her pain before examination of the indicated painful area. participants were then screened for the presence of neuropathic pain based on the douleur neuropathique and sci pain instrument questionnaires to supplement the focused history and exam [ ] . the area of pain was marked using a skin marker and a plastic cut-out template for injection sites separated from each other by a cm radius (fig. ) . to marked areas, participants received subcutaneous injections of either bonta or placebo. each unit vial of bonta was reconstituted with ml preservative-free sterile . % normal saline solution, for a concentration of units of bonta per . ml injectate, as per manufacturer recommendations. placebo consisted of . ml of the same preservative-free sterile . % normal saline. syringes were prefilled by an unblinded physician and research assistant in a separate location from where injections and assessments occurred. the physician administering the injection was blinded to syringe contents. the randomized treatment allocation for each patient was kept in a sealed envelope by another research assistant, separate from those preparing and administering injections. the area was sterilized with alcohol then localized topical anesthesia was provided with sterile ethyl chloride. each injection was given using a gauge needle and administrators were allowed to provide up to injections of units each for a total maximum delivery of units, per participant, per phase injection session. this maximum dose and injection number was determined based on the study team's review of the bonta manufacturer recommendations and the bonta literature to date at the time of protocol formation [ ] [ ] [ ] . following the injection procedure, participants were monitored for ≥ min for immediate aes. they were reeducated on potential aes of bonta (e.g., local hyperesthesia, weakness, erythema), including all serious ones for which they should seek emergency care (e.g., respiratory distress, systemic illness), and provided with contact information for any questions or concerns that they may develop afterwards. neither participants nor their insurance providers were charged for the bonta and participants did not receive any monetary reimbursement for participation. the bonta was stored in a locked refrigerator ( - °c), labeled in a location separate from the outpatient sci clinic. our primary outcome measure was patient reported average pain intensity over the prior week in their area of worst pain as indicated above. this measure is part of the international sci pain basic data set (iscipbds), whose validity and utility in individuals with sci have been demonstrated, and it is among the measures recommended for use in sci clinical trials [ ] [ ] [ ] . participants were asked to rate their average pain using the - nprs from ("no pain") to ("worst pain imaginable"). secondary outcome measures included other iscipbds items, such as the degree to which pain interfered with: ( ) day to day activities, ( ) mood, and ( ) sleep, all on scales from ("no interference") to ("extreme interference"). we defined "marked improvement" as a ≥ -point difference based on the minimal clinical important difference (mcid) for the nprs being ≥ points [ ] . at each follow-up time point, participants were asked to quantify the change in quality of life (qol) appreciated after injections on a -point scale based on the patient global impression of change scale [ ] . lastly, participants were asked about and monitored for aes as described above. all collected data were stored in a password-protected redcap database [ ] and all hard copy forms were kept in locked files in the offices of research staff. statistical analyses were performed using spss version . . power analyses were conducted based on the primary outcome of change in pain intensity from baseline. we determined that mcid on the nprs would be ≥ points, that % of participants in the placebo group would have positive response to treatment, and that % more participants (i.e., %) would respond in the treatment group [ , , ] . assuming a two-sided alpha of . , a sample size of would provide % power. assuming a % drop out rate, a sample size of participants was deemed necessary for sufficient power to detect treatment effect. our study failed to meet target sample size therefore it was determined that our findings would be best presented as a descriptive case series and descriptive statistics were used for participant characteristics and all outcomes. among enrolled and consented participants, did not proceed to injections because they were deemed ineligible for the study during the pre-procedure history and physical or they declined participation in the study at this point. among the eight participants who proceeded, five started the study with bonta. all participants finished the p arm of the study. a single bonta recipient withdrew from the fig. template used to administer botulinum toxin a (bonta) and placebo injections study prior to starting the p arm, reporting increased pain after completing p (participant was blinded to whether bonta or placebo was given). one participant starting the study with bonta and two starting with placebo were lost to follow-up during p . a total of four participants finished both p and p arms (fig. ). participants had a median age of years (range - years) and were predominantly male ( %). all had traumatic, thoracic t to lumbar l level, complete sci (american spinal injury association impairment scale grade a). median duration of injury was years (range - years). table shows detailed participant demographics and injury characteristics. participant c reported some pain reduction at weeks post-bonta, marked reduction at , , and weeks, but not post-placebo. participant d reported some pain reduction at and weeks post-bonta but at the week follow-up, withdrew from the study prior to receiving placebo, reporting increased pain after finishing p . participant e reported some pain reduction at , , and weeks post-bonta, but received placebo for p some months after -week follow-up for p then was lost to follow-up. participant f reported marked pain reduction at and weeks post-bonta but not post-placebo. participant g reported no pain reduction post-placebo, received bonta for p concurrently with -week follow-up for p , then was lost to follow-up. participant h reported no pain reduction post-placebo, received bonta for p some months after -week follow-up for p , then was lost to follow-up (table ) . participants a and c reported no marked improvements compared with baseline in day to day activities, mood or (table ) . participant a reported his qol was "moderately better, with a slight but noticeable change" at and weeks post-bonta. participant b reported his qol was "somewhat better" at and weeks post-bonta. participant c reported "somewhat" better qol at weeks and "moderately" better qol at weeks post-bonta (item assessment missed at weeks). participant d reported qol that was "moderately better, with definite improvement" at weeks post-bonta, but progressively reduced qol at , , and weeks. participant e reported his qol was "somewhat" better weeks post-bonta but reported minimal improvements at , , and weeks. participant f rated his qol as "moderately better, with definite improvement" at and weeks post-bonta, and "somewhat better" at weeks post-bonta (table ). one participant attributed an ae related to bonta injection itself: participant d, who initially reported some improvements in pain, activities, mood, sleep, and qol post-bonta, reported that overall his pain worsened at weeks and withdrew from the study (tables - ) . two participants reported an ae during the course of the study crossover -week follow-up intensity reported using numeric pain rating scale, from ("no pain") to ("worst pain imaginable") cross-over -week follow-up degree of interference reported using a numeric scale with endpoints of ("no interference") to ("extreme interference") (participant a reported "thrombosis of a preexisting inferior vena cava filter" and participant h reported "a fever from a cold") but both denied feeling the events were related to the study. our study sought to explore whether the subcutaneous injection of bonta is a feasible approach for the control of at-level sci pain. this study was designed as a randomized, double-blinded, placebo-controlled, crossover study. however, we failed to meet target sample size and determined our findings would be best presented as a descriptive case series. our data did not meet statistical significance and we were not statistically powered to, but we did note various patterns of improved pain, activities, mood, and sleep among participants after bonta. more participants reported a marked change in average pain intensity from baseline to and weeks post-bonta vs. post-placebo ( % vs. %). at and weeks post-bonta, almost all participants reported some degree of reduced pain; the same was not seen post-placebo ( % vs. %) ( table ). this is consistent with han et al.'s findings that, at and weeks after bonta injections, visual analog scale scores for pain were significantly reduced by . ± . and . ± . , but only reduced by . ± . and . ± . after placebo injections [ ] . more participants reported markedly reduced pain interference with day to day activities at and weeks post-bonta vs. post-placebo ( % vs. %). more participants reported markedly reduced pain interference with mood post-bonta vs. post-placebo at ( % vs. %), ( % vs. %), and ( % vs. %) weeks. more participants reported markedly reduced pain interference with sleep post-bonta vs. post-placebo at ( % vs. %), ( % vs. %), ( % vs. %) and ( % vs. %) weeks (table ) . lastly, more participants reported at least moderate improvements in qol post-bonta vs. post-placebo at ( % vs. %) and ( % vs. %), ( % vs. %), and ( % vs. %) weeks (table ). this too supports han et al.'s trend towards improvements at weeks post-bonta (p = . ) on the physical health domain of the whoqol-bref, which includes facets like activities of daily living and sleep [ ] . our data was statistically insufficient to draw conclusions regarding the effects of bonta on at-level sci pain. despite this, we managed to demonstrate several interesting patterns within our participants' reports on how they felt post-bonta. participants also denied any significant aes = "almost the same, hardly any change at all" = "a little better, but no noticeable change" = "somewhat better, but the change has not made any real difference" = "moderately better, a slight but noticeable change" = "moderately better, a definite improvement that has made a real worthwhile difference" = "a great deal better, a considerable improvement that has made all the difference" a item data could not be obtained for participant c at weeks follow-up for phase (p ) from receiving bonta injections, consistent with the drug's favorable safety and tolerability profile demonstrated in the literature to date [ , ] . one withdrew from the study reporting worsened pain following bonta injections, but it was later noted this participant had initially reported improvements in pain, activities, mood, sleep, and qol post-bonta. the largest limitation to our study was our failure to meet target sample size due to low recruitment and retention rates. bonta injections were offered for free but the time, planning, and costs required of participants to coordinate injection visits were inadequately accounted for. coordinating follow-ups also proved to be difficult once participants received injections, possibly because patients lost incentives to continue participating. these issues could be better addressed with more resources for both improved recruitment and retention in the future. based on our findings, we encourage the field to continue considering bonta as a potential option for treating at-level sci pain. we further hope that sharing our limitations may facilitate additional investigations into this treatment method throughout the field. several encouraging patterns among participants with respect to self-reported average pain levels; pain interference with day to day activities, mood, and sleep; as well as overall qol as related to pain were observed post-bonta injections. these findings are consistent with the literature to date and incite us to continue investigating subcutaneous bonta as a feasible approach for the control of at-level sci pain. survey data are available from the corresponding author upon reasonable request. international spinal cord injury pain (iscip) classification: part . initial validation using vignettes a prospective study of pain and psychological functioning following traumatic spinal cord injury a longitudinal study of the prevalence and characteristics of pain in the first years following spinal cord injury pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis the canpain sci clinical practice guidelines for rehabilitation management of neuropathic pain after spinal cord: recommendations for treatment physical medicine and rehabilitation board review botulinum toxin type a for neuropathic pain in patients with spinal cord injury central origin of the antinociceptive action of botulinum toxin type a botulinum toxin a, brain and pain botulinum toxin treatment of pain syndromes-an evidence based review complications of botulinum neurotoxin safety of botulinum toxin type a: a systematic review and meta-analysis treatment of at-level spinal cord injury pain with botulinum toxin a. [presentation] american congress of rehabilitation medicine th annual conference cut point determination in the measurement of pain and its relationship to psychosocial and functional measures after traumatic spinal cord injury: a retrospective model spinal cord injury system analysis screening for neuropathic pain after spinal cord injury with the spinal cord injury pain instrument (scipi): a preliminary validation study botulinum toxin for diabetic neuropathic pain: a randomized double-blind crossover trial subcutaneous injection of botulinum toxin a is beneficial in postherpetic neuralgia botulinum toxin type a for the treatment of trigeminal neuralgia: results from a randomized, double-blind, placebo-controlled trial pain after spinal cord injury: an evidence-based review for clinical practice and research. report of the national institute on disability and rehabilitation research spinal cord injury measures meeting reliability and validity of the international spinal cord injury basic pain data set items as selfreport measures the international spinal cord injury pain basic data set clinically significant change in pain intensity ratings in persons with spinal cord injury or amputation research electronic data capture (redcap)-a metadata-driven methodology and workflow process for providing translational research informatics support the powerful placebo acknowledgements we thank dr. tiffany wong (department of rehabilitation and human performance, ismms, new york, ny) for her assistance with injections during her sci fellowship.funding the onabotulinumtoxina (botox) used for this study was provided by allergan (irvine, ca). funding source personnel had no involvement in the study design; collection, analysis and interpretation of the data; or the writing and submission of this paper for publication.author contributions all listed authors have met all of the following authorship criteria: ( ) conceived and/or designed the work that led to the submission, acquired data, and/or played an important role in interpreting the results. ( ) drafted or revised the paper and approved the final version. ( ) agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. conflict of interest the authors declare no conflict of interest.ethical approval we certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research.publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- - nwpic d authors: rennie, katherine j.; o’hara, james; rousseau, nikki; stocken, deborah; howel, denise; ternent, laura; drinnan, mike; bray, alison; rooshenas, leila; hamilton, david w.; steel, alison; fouweather, tony; hynes, ann-marie; holstein, eva-maria; oluboyede, yemi; abouhajar, alaa; wilson, janet a.; carrie, sean title: nasal airway obstruction study (nairos): a phase iii, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction date: - - journal: trials doi: . /s - - - sha: doc_id: cord_uid: nwpic d background: septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately , performed annually in the us and , in the uk. most septoplasties aim to improve diurnal and nocturnal nasal obstruction. the evidence base for septoplasty clinical effectiveness is hitherto very limited. aims: to establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. methods/design: a multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ on the nose questionnaire. surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. the recruitment target is patients, recruited from up to sites across scotland, england and wales. randomisation will be on a : basis, stratified by gender and severity (nose score). participants will be followed up for months post randomisation. the primary outcome measure is the total snot- score at months. clinical and economic outcomes will be modelled against baseline severity (nose scale) to inform clinical decision-making. the study includes a recruitment enhancement process, and an economic evaluation. discussion: the nairos trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit. trial registration: eudract: – - , isrctn: . registered on march . (continued from previous page) discussion: the nairos trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit. keywords: nasal septum, nasal obstruction, septoplasty, turbinates, mometasone furoate, clinical trial, cost-effectiveness, process evaluation background septoplasty is surgery to straighten the nasal partition between the two nostrils (the septum). septoplasty is a commonly conducted operation worldwide, with approximately , operations performed annually in the us and approximately , in the united kingdom (uk) [ , ] . most of these are carried out for nasal blockage and associated symptoms such as a snoring and sleep disturbance. nasal blockage is one of the commonest complaints presenting to otolaryngologists. however, the causes may be multiple, and several may be co-existent. septal deviation or lesions in the nasal passages, such as nasal polyps or enlarged adenoids or turbinates, may cause a 'fixed' sensation of blockage. 'fluctuating' blockage symptoms may be caused by inflammatory conditions of the nasal epithelium such as infective or allergic rhinitis. in addition, the 'nasal cycle', a spontaneous physiological congestion and decongestion of the nasal cavity, compounds the challenge in characterising and assessing nasal patency [ ] . the impact of the 'nasal cycle' can be mitigated by measuring nasal airflow following therapeutic nasal decongestion [ ] . ideally, the septum runs down the centre of the nose. if it is not straight, perhaps because of injury or a developmental anomaly, it may narrow one or both sides of the nose and obstruct airflow. a perfectly straight nasal septum in adults is rare and some degree of deviation is an accepted norm. however, in instances where there are symptoms of nasal obstruction and a concomitant deviation of the septum, patients may be offered the septoplasty operation. on the sidewalls of the nose are 'turbinates', tissue structures which are rich in blood vessels and glands. often when the septum narrows one side of the nose, it creates a larger space on the other side, into which the turbinate on that side expands. medical management using topical nasal steroid sprays decongests the nasal lining and may lead to improvement in the symptoms of nasal blockage. however, such treatments are required on a daily, ongoing basis and in practice may not be successful. in addition, side effects of nasal dryness, irritation and bleeding may impact on treatment satisfaction and compliance. when surgery to straighten the septum is carried out, some surgeons also reduce the contralateral turbinate tissue. potential complications of septoplasty include septal perforation, septal adhesions and bleeding [ ] . post-operative pain is common although this is reduced if sutures rather than nasal packing are used [ ] [ ] [ ] . patients typically are advised to take several days off work or usual activities after the operation. septoplasty has no defined selection criteria, particularly in patients whose principal symptoms are sleep related, and clinical practice varies in different centres. the mode of action of septoplasty in sleep-related breathing disorders is not fully understood [ ] [ ] [ ] . the effectiveness of septoplasty with or without turbinate surgery remains unclear and there is a lack of high-quality evidence of its benefit in the literature [ , ] . not all patients improve with surgery. estimates of persistent septal deviation following a septoplasty procedure range from less than % [ ] to % [ ] . where septoplasty fails and further surgery becomes necessary, revision rates are reported to be high [ ] . there is also a lack of robust evidence about the additional benefit of turbinate surgery [ ] . one study showed reduced revision rates for septoplasty when the turbinate tissue is reduced [ ] ; other studies report no added long-term benefit from turbinate reduction [ ] [ ] [ ] . currently, most septal surgery is based on subjective, unstandardised clinical impressions of the contribution of the nasal septum to patients' symptoms. there is also no good comparative evidence regarding alternatives to septal surgery; nor about who might most benefit, to inform patients' and doctors' shared surgical decisionmaking [ ] . whilst it is recognised that that the evidence base for septoplasty is ambiguous [ ] , it is important to take into account the variations between men and women in relation to the operation. firstly, septoplasty is more common in men [ , ] and, secondly, there is a known gender influence on response to nasal-patient reported outcome measures [ ] . the aim of nairos is to establish, and inform guidance for, the best management strategy for patients with nasal obstruction associated with a deviated nasal septum, via a randomised controlled trial (rct) of surgery versus medical management across sites in both secondary and tertiary hospitals across england, scotland and wales. to establish, and inform guidance for, the best management strategy for participants with nasal obstruction associated with a deviated septum, via a randomised controlled trial comparing the clinical and costeffectiveness, of nasal septoplasty plus/minus (±) contralateral turbinate reduction versus medical management. the study objectives are split into three different aspects: clinical effectiveness, economic evaluations and mixedmethod process evaluation. clinical effectiveness to measure clinical effectiveness according to: subjective self-report rating of nasal airway obstruction heterogeneity of estimated treatment effect specifically according to severity of obstruction and gender objective measures of nasal patency number of adverse events (aes) and additional interventions required technical failure in the surgical arm how well those agreeing to enter the trial reflect those screened for eligibility the cost-effectiveness of each intervention the cost-utility with outcomes reported as incremental cost per quality adjusted life year (qaly) gained a longer-term economic model to assess costs and health consequences beyond -month follow-up period all economic analyses will be conducted from the perspective of the national health service (nhs) and participants mixed-methods process evaluation of the trial and interventions our mixed-method process evaluation will identify, describe, understand and address: barriers to optimal recruitment, and potential solutions to address these, through integration of the quintet recruitment intervention (qri) [ , ] participants' and healthcare professionals' experiences of trial participation and the interventions under evaluation factors likely to influence wider implementation of trial findings the design, measured outcomes and analysis of the process evaluation and qri are detailed later in this manuscript. a multicentre, randomised controlled, open-label trial, incorporating a qualitative process and economic evaluation. participants will be randomised on a : basis between septoplasty, with or without turbinate reduction, versus medical management (isotonic saline nasal spray (sterimar) and mometasone nasal spray) of nasal obstruction. participants in the medical management arm will be asked to use the nasal sprays twice daily for weeks, then once daily for the remainder of the -month period. recruitment will take place over months, with trial completion complete at months (submission of final report). the trial will take place in nhs hospitals across scotland, england and wales (see the isrctn registry number ). an overview of the nairos schedule of events patient pathway is shown in fig. . adults (aged ≥ years) referred by their general practitioner (gp) to ear, nose and throat (ent) secondary care outpatient clinics who are found to have a deviated septum on nasendoscopy and reduced nasal airway as indicated by a nose score ≥ . ent staff will also be recruited for participation in a process evaluation. the nairos eligibility criteria are listed in table . hospital researchers will proactively identify nairoseligible patients through triage of referral letters of rhinology patients to the ent department, and issue an invitation to attend a research clinic. patients attending a research clinic will, where possible, have been sent the patient information sheet (pis) with their appointment details, and have been directed to the patient information video, available at www.nairos.co.uk. all patients will have been given a minimum of h after receiving the pis to decide whether or not they would like to take part. the main pis can be found in additional file . consent a delegated member of the research team will undertake informed consent discussions with the opportunity for the patient to ask any questions and discuss the trial in more detail. patients will be invited to give informed, written consent in three stages. firstly, consent to undergo screening (eligibility). secondly, consent to have the discussion about the nairos trial with the investigator audio-recorded and their details passed onto • any prior septal surgery • systemic inflammatory disease or the use of any current oral steroid treatment within the past weeks • granulomatosis with polyangiitis • nasendoscopic evidence of unrelated associated pathology, e.g. adenoid pad, septal perforation, chronic rhinosinusitis indicated by the presence of polyposis or pus • any history of intranasal recreational drug use within the past months • breast-feeding, pregnancy or intended pregnancy for the duration of involvement in the trial • bleeding diathesis • therapeutic anticoagulation (warfarin/novel oral anti-coagulant (noac) therapy) • clinically significant contraindication to general anaesthesia • patients known to be immuno-compromised • those in whom an external bony deformity substantially contributes to the nasal obstruction a member of the qualitative team for a telephone interview. finally, eligible patients are invited to give consent for the main trial, and to also give consent to potential future sharing of their anonymised data with other researchers not related to the nairos study. the patient informed consent form can be found in additional file . screening screening data used to assess eligibility will include: clinical examination (including nasal endoscopy) nasal obstruction symptom evaluation scale (nose) scoreconfirmation of total ≥ age baseline recording of four core features at endoscopy of the undecongested nose • the side of the maximum convexity • one main site of deflection on each sideanterior/ posterior/upper/lower/all) • confirmation that there is no excluding inflammatory processpus/polyps/adenoids • magnitude of observer-rated airway block (< %; ≥ %) if the participant is unable to complete the endoscopic examination without topical preparation, it can be performed after the airway assessment of the decongested nose. the nose scale is a validated five-item, unifactorial self-report of nasal-block severity which has been applied in previous research and audit studies [ , ] . the three recognised nose-derived categories of baseline severity used will be: - = moderate, - = severe, - = extreme [ ] . for nairos, it is anticipated that baseline severity will be the most important determinant of outcome. those with a nose score of less than will be excluded from nairos on the basis of having symptoms that are too mild to warrant inclusion. randomisation at the baseline visit, consenting, eligible patients will be randomised on a : basis using random permuted blocks of variable length. stratification will be by gender and baseline severity (nose score). randomisation will be administered centrally by the newcastle clinical trials unit (nctu) web-based system. the treatment allocation is open label and the randomisation system will provide a unique trial identifier for each participant via email to a delegated member of site staff. participants will be randomised between: . septoplasty with or without unilateral turbinate reduction . medical management participants allocated to the septoplasty group will undergo surgical correction of the nasal septal deviation ± unilateral reduction of the inferior turbinate on the concave side. a preliminary secondary care feasibility exercise revealed that there is considerable variation in surgical practice around the uk; rates of contralateral turbinate reduction varied between nairos centres from to % of septoplasties. as a pragmatic study, nairos does not ask surgeons to change their usual practice in relation to contralateral turbinate reduction. nairos surgeons may or may not carry out unilateral turbinate surgery on the wider side, according to their assessment of the individual patient airway. intention to reduce one turbinate will be recorded prior to randomisation. details of the actual surgery performed will also be collected. participants will have a closed septoplasty, will be sutured, not packed, and will be a day case (where possible). the recommended post-operative twice-daily regimen will be of saline douche plus naseptin nasal cream (or if the patient is allergic to the peanut content of naseptin, bactroban % ointment). participants will be recommended to take a few days off work. nasal-steroid and saline sprays should not be part of routine standard post-operative care for nairos. any additional medication required by participants will be recorded as concomitant medication. surgery must be carried out anytime up to weeks (+ weeks) after randomisation. the additional -week window is to allow for extenuating circumstances only, such as unexpected patient or clinical reasons that necessitate a delay in surgery. reasons for delays to surgery will be collected and reported. the surgical intervention will be performed by surgeons who have completed their training. patients randomised to the medical management arm will be asked to use a combination of an isotonic spray with a full twice-daily dose of a fluorinated steroid spray (mometasone furoate) which is a typical maximal medical therapy regime over a -month period. preparatory work by the chief investigator indicated that most patients referred from their gp have never used this sustained combination therapy. sterimar isotonic nasal spray dose: one spray (metred dose) into each nostril prior to using the mometasone nasal spray. mometasone nasal spray dose: mcg (two sprays) into each nostril twice daily for weeks, followed by mcg (two sprays) into each nostril once daily or mcg (one spray) into each nostril twice daily for the remainder of the -month period. participants who wish to discontinue their allocated treatment, but remain in the trial, may access other treatments via the standard local nhs route. such participants will be followed up as per their allocated treatment intervention arm. participants in the surgical arm who wish to pursue medical treatment will not receive the trial investigational medicinal product (imp) prescription. participants in the medical arm who wish to receive surgery and remain eligible for septoplasty should be added to the elective nhs waiting list. the primary analysis is comparison of the comprehensive, validated sino nasal outcome test- (snot- ) [ ] patient-reported scores at months from randomisation (− weeks to + weeks), with complete follow-up of participants to months post randomisation. snot- is a commonly employed patient reported outcome measure in the assessment of patients with pathologies of the nose and sinuses [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] and was first applied to septoplasty in [ ] . our ppi work found that patient symptoms mapped better to the snot- than to the nose and that patients preferred the snot- measure. to maximise collection of primary outcome measure, participants who cannot attend the -month follow-up visit may complete snot- by post. secondary outcome measures can be categorised into patient-reported, safety, economic, exploratory and qualitative. patient reported outcome measures (proms) proms will be used to measure long-term change in nasal patency and quality of life: snot- subscales (rhinologic, sleep, ear/facial pain, psychological) at months nose scale at months double ordinal airway subjective scale (doass)administered post nasal decongestant use only at months. doass is a subjective comparator of right and left nasal patency [ ] allowing direct comparison with the spirometry measures safety outcomes safety outcomes will be measured by the number and characteristics of any aes, and surgical complication/failure and re-intervention within months. economic outcomes economic outcome measures include: qaly gained using the -item short form health survey (sf- ) questionnaire ( -week recall), further converted into qalys using the health economy survey derived from sf- (sf- d) algorithm [ ] , at months, and aes avoided use of and timing of additional interventions in primary and secondary care recorded by health care utilisation questionnaire at months and months number of days unable to undertake usual activities recorded by health care utilisation questionnaire at months and at months incremental cost per change in snot- at months costs to nhs and participants at months longer-term economic model to assess costs and health consequences beyond the trial exploratory outcome measures two of the most common objective measures of nasal patency, used in some overseas healthcare systems to assess likely benefit from septoplasty, are peak nasal inspiratory flow rate (pnif) and nasal partitioning ratio (npr) [ ] . pnif and npr will be used in this trial as exploratory outcome measures. all sites will be provided with two devices to measure two different measurements of nasal patency: pnif, measured with a pnif meter (peak nasal inspiratory flow (pnif) meter; gm instruments, kilwinning, uk) npr, measured using the nv rhinospirometer (nv rhinospirometer; gm instruments, kilwinning, uk) the two standard measurements will each be made before and after decongesting the nasal turbinate tissue with xylometazoline at baseline and at and months following randomisation. pnif measures the peak flow rate of air through both nostrils during inhalation using a pnif meter with a face mask. the participant holds the mask over the nose and mouth, closes the mouth and inhales maximally (sniffs). pnif has been shown to respond to septoplasty/turbinectomy [ ] and can, therefore, be used for an overall assessment of nasal airflow impairment, and as an objective outcome measure from surgery. however, pnif does not differentiate between the two nostrils. bench testing shows the nv rhinospirometer to be an accurate and precise objective marker of airflow symmetry [ ] . the nv rhinospirometer has two separate channels to measure the volume of air passing through each nostril, hence deriving the npr, the difference between right and left volumes divided by the sum. npr ranges from symmetrical ( ) to completely unilateral (± ). the npr appears to predict the septal surgery outcome [ , ] . comparison of npr during both maximal inhalation and normal tidal breathing will allow the comparative utility of these two measures to be compared and demonstrate any change in nasal function following treatment. qualitative outcomes qualitative outcomes will be identified through observations of training and nairos meetings, interviews with health professionals and participants, and audio-recording of recruitment discussions. the trial schedule of events is presented as a flow diagram (fig. ) and using the standard protocol items: recommendations for interventional trials (spirit) figure [ ] (fig. ) . participants recruited to the main trial will be followed up for months from the point of randomisation. data including the number of participants screened, approached and interested in taking part will be collected via a log completed by site staff conducting screening. assessments pre-randomisation eligible patients who consent to participate in the main trial will have the following outcome measures administered prior to randomisation: site nursing staff will record details of any concomitant medication and aes during a phone call at weeks after surgery has taken place, and at all scheduled trial visits. medical management arm data as a pragmatic trial using standard treatment as part of the medical management arm, precise assessment of any mometasone furoate spray and sterimar spray residuum will not take place. participant compliance with the imp does not form part of the trial monitoring plan. participants will be asked at the -month follow-up visit (visit ) to estimate how many bottles of the sterimar and mometasone furoate spray they used. site nursing staff will record details of concomitant medication and any aes during a phone call at weeks post randomisation and at all scheduled trial visits. data will be handled, computerised, stored and archived in accordance with the general data protection regulation ( ), and the latest directive on good clinical practice (gcp) ( / /ec). patient-identifiable data will remain at each site and not be collected as part of the trial dataset. patient identification on data collection tools used during screening will be through a unique sequential screening number allocated by site staff. patients recruited to the main trial will additionally be identified by a unique trial identifier number generated by the randomisation system. data will be transcribed and npr files uploaded by site staff to the trial's secure, password-limited, validated macro™ database (elsevier). the participant trial record, including completed paper data collection tools, will be archived at site for years following the end of the trial. audio-recordings will be archived for years. the trial will be conducted in accordance with the medicines for human use (clinical trials) regulations and subsequent amendments. all parties must abide by these regulations and the international conference on harmonisation-good clinical practice (ich-gcp) guidelines. participants who withdraw their consent from the trial, or are withdrawn by the investigator, will not be replaced. all data collected up until the point of withdrawal will be retained for nairos research purposes, and consent will be sought for this (additional file ). the snot- minimal clinically important difference (mcid) in the national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis was . [ ] . septal surgery is reported variously as showing reductions in total snot- scores above ( points) [ ] or below ( points) this boundary [ ] . in the absence of a specific figure for septoplasty mcid, nairos has assumed a clinically relevant reduction being at least points. reported standard deviations (sd) of the snot- score were [ ] (in external septoplasty) to [ ] in septorhinoplasty, nairos assumed the larger, more conservative sd. sample size calculations were based on a t test for superiority assuming equal variance across groups, a conservative estimate given the primary analysis is based on adjustment for stratification covariates, increasing power. the target recruitment of participants allows for % drop-outbased upon experience from our unit's two prior septal surgery audits [ , ] . the remaining participants ( per arm at completion), are required to show a -point [ ] difference in overall snot- score between arms, with % power and % type i error, assuming a sd of . primary outcome the primary analysis is comparison of snot- scores at months by randomised treatment arm (immediate surgery vs medical management). mean overall scores will be presented by treatment group. the associated significance of any observed difference will be calculated in multivariable regression models adjusting any treatment effect by stratification factors, gender and nose severity at baseline. secondary analysis of the primary outcome measure will adjust for the influence of baseline severity snot- score as a continuous covariate, planned turbinate reduction as a binary covariate and other important demographic and clinical covariates at randomisation (including, but not exclusively, age, body mass index (bmi), smoking, endoscopic features). non-linear relationships between continuous baseline measures and outcome will be addressed by simple, and possibly more complex, fractional polynomial transformations. the nairos model will generate a linear predictor score of patient outcome weighted according to the statistical importance of each covariate. each patient's linear predictor score will be compared against observed score for internal validation. this model will be used to explore recommendations for treatment options. the importance of baseline severity, as a continuous distribution of nose score at randomisation, may be further explored graphically by subpopulation treatment effect pattern plots (stepp analysis) [ ] to display the predicted point estimates of any treatment effect (with % ci) over the range of nose values (range - in nairos participants), further informing any patient selection guidance and recommendations. primary statistical analyses will be carried out on an intention-to-treat basis. the number of ineligible participants and reasons for ineligibility will be reported. a sensitivity analysis may be conducted and reported if the number of ineligible participants or participants not receiving the allocated treatment is excessive. participants may choose to discontinue the treatment to which they have been allocated, and may also ask that they receive an alternative treatment as per local standard nhs care. the implication of such treatment adjustments, which typifies surgical trials, is that the intention-to-treat analysis will produce a conservative estimate of the effect of septoplasty. non-compliance (including receiving the alternative treatment) may be addressed using an 'as treated' approach or complier average causal effect (cace) approach, since the intention-to-treat analysis under noncompliance is biased when the intervention effect is large [ ] . statistical methods for withdrawal of participants, based on statistical censoring, may be considered. tests of heterogeneity will assess robustness of the overall treatment effect across stratification subgroups, and by intention to perform unilateral turbinate reduction. there are no formal interim analyses of the primary outcome measure and there are no formal statistical stopping rules. decisions regarding continuation of the trial will be made at dmc meetings held every months. decisions will be made on the basis of information presented in a statistical report that includes analysis of formal data snapshots, including safety data. analysis of secondary outcomes analyses of secondary outcomes will follow a broadly similar strategy. these will include the data at -month follow-up from the other outcomes (snot- subscales, nose, doass, sf- ) and that for all outcomes at -month follow-up. subjective scales, tabulated by arm and overall at randomisation, -month and -month follow-ups, will be compared by both summary statistics and graphical representation. multiple regression will be used to investigate longitudinal outcome scores between treatment groups at follow-up time points. variation between participants will be included as a random effect with an assumed normal distribution. analysis will include the stratification factors of baseline severity and gender. further adjusted analyses will include terms for baseline values of the scores and key demographic and clinical covariates. adverse events will be tabulated according to world health organisation (who) common terminology criteria for adverse events (ctcae) grade version . . number of severe (ctc grade , or ) will be reported as a proportion of all aes. number of participants experiencing at least one severe ctcae will be reported as a proportion of all participants. surgical complication/failure and re-intervention will be tabulated and will not subject to statistical testing. technical failures from operations where widening of nasal airway was achieved yet the symptoms persist will be reported. analysis of exploratory outcomes three measurements each of pnif and npr during maximal inhalation will be made. either the maximum (pnif) or average (npr) value is used. summary statistics will be presented for pnif and npr by arm and overall, at baseline, -month and month follow-ups. design the process evaluation incorporates the qri and mixed qualitative methods. data collection and analysis will commence during study set-up and continue throughout the trial. randomising patients between surgical and medical arms can be challenging. the qri, based at bristol university, will assist in the identification and methods of addressing such challenges. the qri uses novel qualitative and mixed-method approaches pioneered during the national institute for health research (nihr) health technology assessment (hta)-funded protect (prostate testing for cancer and treatment) study [ ] . these methods have since been applied to several other 'challenging' or controversial rcts in different clinical contexts, all of which have led to insights about recruitment issues and the development of generic and bespoke strategies to optimise recruitment [ ] . the qri will coincide with the study set-up and the first year of recruitment, using qualitative and novel methods to investigate and address recruitment barriers (objective a, below) [ ] [ ] [ ] . qualitative interviews will be conducted throughout the trial to investigate patients' and clinicians' experiences of the study procedures, interventions and barriers to implementing findings into practice (objectives b and c, below). sampling strategy the sampling strategy is informed by current and prior experience [ , , ] . in keeping with the principles of rigorous qualitative research, sampling will be responsive to the study context. in some cases fewer interviews or observations will be conducted, and in others, additional data will be required to accommodate our emerging analysis or study events. numbers of interviews will be guided by 'data saturation'continued sampling until findings become repetitious. objective a: optimising recruitment -qri (study set-up and first year of recruitment) working in close collaboration with the trial management group (tmg), the qri team will assimilate investigational and interventional approaches to understand and address recruitment difficulties in the early stages of nairos. the findings and implications of the qri will continue to be implemented by the tmg and study investigators throughout the remainder of the trial recruitment period. the qri will proceed in two iterative phases: a detailed understanding of the recruitment process will be developed in phase i, leading to tailored interventions to improve recruitment in phase ii. phase i: understanding the recruitment process and how it operates in individual centres. a multi-faceted, flexible approach will be adopted, comprising one or more of the following methods: (a) in-depth interviews, conducted with: members of the tmg (n = - ); clinicians or researchers involved in trial recruitment (n = - ); and eligible patients who have been approached to participate in the trial (n = - ). interviews will explore views on trial processes, perceptions of equipoise, and information about how the protocol is operationalised in clinical centres (b) audio-recording and non-participant observation of consultations during which the trial is discussed with patients, enabling identification of clear and subtle obstacles to recruitment (c) mapping of eligibility and recruitment pathwaysnoting the point at which patients receive information about the trial, which members of the clinical team they meet, and the timing and frequency of appointments. the qri researcher will work closely with the clinical trials unit to compose logs of potential rct participants as they proceed through screening and eligibility phases (d) regular observation of tmg and investigator meetings to gain an overview of trial conduct and overarching challenges (logistical issues, etc.) (e) scrutiny of study documentation (e.g. piss) to identify aspects that are unclear or potentially open to misinterpretation phase : development and implementation of recruitment strategies. anonymised findings from phase i will be presented to the tmg, summarising the factors that appear to be hindering recruitment. a plan of action will be devised in collaboration with the tmg if there is consensus that aspects of practice are amenable to change. interventions will be tailored to the nature of recruitment challenges identified. generic forms of intervention may include 'tips' documents on how to explain trial design and processes. supportive feedback will be a core component of the plan of action, with the exact nature and timing of feedback dependent on the issues that arise. centre-specific feedback may cover institutional barriers, whilst multicentre group feedback sessions may address widespread challenges. individual confidential feedback will be offered where there is a need to discuss specific challenges or potentially sensitive issues. objectives b and c: understanding experiences of septoplasty and non-surgical management we will investigate patients' (n = [ ] [ ] [ ] [ ] [ ] and health professionals' (n = - ) experiences of the interventions and trial participation through qualitative interviews conducted during patient follow-up. where possible, patients for the follow-up interviews will include those interviewed during the recruitment phase; additional participants will be recruited based on purposive and emergent criteria (e.g. patients who have declined their allocated treatment). we will identify any aspects of the care pathway which are problematic for patients or health professionals; and potential barriers and facilitators to wider acceptance and implementation of trial findings. a focus group of gps will explore preliminary trial findings and discuss implications for primary care management of nasal obstruction. our analysis of the implementation of study findings will be informed by normalisation process theory (npt) [ ] . qualitative data management and analysis all interviews will be audio-recorded, transcribed verbatim and edited to ensure anonymity of respondents. contemporaneous field notes from non-participant observation in clinical settings will be edited to ensure anonymity of participants. data will be managed using nvivo software. the analysis will be conducted according to the standard procedures of rigorous qualitative analysis which we have described previously [ ] , including open and focussed coding, constant comparison [ ] , memoing [ ] , deviant case analysis [ ] and mapping [ ] . we will undertake independent coding and crosschecking and a proportion of data will be analysed collectively in 'data clinics' where the research team share and exchange interpretations of key issues emerging from the data. audio-recorded recruitment consultations will be subjected to content, thematic and novel analytical approaches, including targeted conversation analysis [ ] and quanti-qual appointment timing (the 'q-qat method') [ ] . there will be a focus on aspects of information provision that is unclear, disrupted, or potentially detrimental to recruitment and informed consent. all participants who complete the nairos trial, or who discontinue the treatment interventions at any point, will be offered standard, local nhs care in discussion with their local investigator. the sponsor will provide indemnity in the event that trial participants suffer negligent harm due to the management of the trial. this indemnity will be provided under the nhs indemnity arrangements for clinical negligence claims in the nhs. the trial steering committee (tsc), data monitoring committee (dmc), trial statistician, data manager and other members of the central trial team as required will have access to the full trial dataset. individual site trial datasets will not be available to individual site investigators prior to publication of the main trial results. all requests for data should be directed to the corresponding author for consideration. access to the anonymised final trial dataset may be available following review; we will retain exclusive use until publication of major outputs. the results of the trial will be presented at topic-specific national or international conferences and published in a general medical journal with the monograph published by hta. authorship of all publications will be on a named individual authorship basis. for each publication, all individuals who fulfil the authorship definition for the publishing journal or site will be included as individually named authors. authorship order will be decided by the chief investigator and tmg. a lay summary of results and the hta report will be available on the nairos website. members of the patient and public involvement (ppi) panel will review results and they will be involved in writing lay summaries of results for dissemination to relevant patient groups. nctu staff will monitor trial conduct and data integrity to ensure that the trial is conducted in accordance to the latest directive on gcp ( / /ec). this will be detailed in a data management plan and a monitoring plan approved by the trial sponsor. safety reporting delegated nursing staff will interview participants to collect and record any aes. this will take place at every trial visit (n = ), and also via safety phone calls; weeks after randomisation for medical management arm participants, and weeks after septoplasty for surgical arm participants. serious adverse events (saes) will be assessed for any relationship to the treatment intervention (causality), and expectedness (by reference to the reference safety information (rsi)) of any serious adverse reactions (sars). only a qualified medical doctor, delegated to do so at site, may assess the causality and expectedness of each sae. trial management group a trial management group, facilitated by nctu, will convene approximately monthly throughout the duration of the trial. members will consist of key nctu staff, the chief investigator, local clinical co-applicants, trial statisticians, a sponsor representative and staff representing health economics, qualitative and quintet recruitment intervention teams. independent data monitoring committee an independent data monitoring committee (dmc) has been appointed to provide an independent review of participant safety and data endpoints. the independent members comprise two statisticians and a clinician. the dmc will meet at least annually, and report directly to the trial steering committee (tsc). trial steering committee a tsc has been appointed to provide overall independent supervision of the trial. members consist of an independent chair, two independent clinicians, an independent statistician, an independent health economist and three patient representatives. the tsc will meet least annually, after a dmc meeting. all substantial changes to the protocol were approved by the local uk hra research ethics committee, and standalone minor changes (version . ) were approved by the health research authority (hra), prior to implementation at sites. the current, full protocol is available to view on the trial funder's website: https://fundingawards.nihr.ac.uk/search. a summary of key changes to the protocol during the trial is listed in table . there is a paucity of evidence underlying the indications for septoplasty in the uk. at present, the decision to perform septoplasty is based on the clinician's subjective estimation of the impact on the affected nasal airway caused by a deviated septum. in addition, there is a lack of evidence of the impact of a standardised topical medical treatment regimen on the nasal airway in the presence of a septal deflection. at a time of rising healthcare costs and increasing scrutiny on the requirement to justify clinical interventions there is an urgent need to answer these questions. the aim of nairos is to perform a rct to compare surgical treatment to a standardised dual medical therapy (sterimar spray and mometasone spray) and estimate the effectiveness based on subjective nasal symptoms, objective airway measurements and the impact on quality of life. furthermore, a number of other interactions will be measured at baseline, and months following randomisation. the impact of known covariates including sex, turbinate enlargement and subjective degree of nasal obstruction will be assessed. nairos is a pragmatic 'real-world' trial, researching a common surgical intervention against a contemporary comparator in such a way that the results will be generalisable to nhs patients in whom it is offered. however, limitations are anticipated in both treatment arms. in the surgical arm clinicians may vary in their assessment and documentation of the nasal septum deflection. it is also recognised that there are shortcomings in objective measurements of the nasal airway [ ] . in the medical arm we are not monitoring quantities of nasal-steroid used and instead relying on patientreported use. nairos will also compare the cost-effectiveness, to the patient and the nhs, of both the medical and surgical arms of the trial. the challenges and barriers to patient recruitment will be analysed by the quintet recruitment intervention with a view to identifying and minimising these. a qualitative evaluation will explore the views of participants and staff and their experience of the intervention to enable us to shape guidelines and inform clinical decision-making in patients with a deviated nasal septum. the overarching aim will be to shape future guidance on the management of a deviated nasal septum in an nhs setting. the nairos trial is currently working to protocol version . , dated january . recruitment began on january , and is due to end on january . supplementary information accompanies this paper at https://doi.org/ . /s - - - . • specification of the location of the rsi within the mometasone smpc . , nov • specification of the decongestant spray to be used alongside the nasal patency measurements (xylometazoline) and classification of the decongestant spray as a nimp • clarification of the exclusion criteria regarding the use of orally administered steroids and updating the exclusion criteria to exclude patients who have an external bony deformity that is likely to make a substantial contribution to the nasal obstruction . , jun • update to the mometasone rsi • update the exclusion criteria from any history of intranasally administered recreational drug use to any history of intranasal recreational drug use within the past months • clarify the clinical examination procedure to state that patients who request local anaesthetic for nasal endoscopy may have the nasal endoscopy assessment carried out after the other trial assessments have been completed • clarification of the timing for the surgical intervention to state that patients randomised to septoplasty must have their septoplasty anytime within weeks of randomisation . , dec addition of a -week window to the timeline for surgery for use in extenuating circumstances (i.e. weeks + weeks) • change the window for the -month visit from ± weeks to − weeks/+ weeks to maximise collection of the primary outcome measure • clarification of management of patients between the -month and -month follow-up visits • clarification of management and options for participants who wish to discontinue with their allocated treatment and explore other surgical or medical treatments as part of standard nhs care • state that discontinuation of allocated treatment does not constitute withdrawal from the trial. update to the rsi for the surgical intervention ambulatory sinus and nasal surgery in the united states: demographics and perioperative outcomes admitted patient care -england nasal patency: problems in obtaining standard reference values for the surgeon complications in septoplasty based on a large group of patients is nasal packing necessary after septoplasty? a meta-analysis open versus endoscopic septoplasty techniques: a systematic review and metaanalysis quality of life and symptoms before and after nasal septoplasty compared with healthy individuals surgical treatments for snoring nasal obstruction considerations in sleep apnea nasal septoplasty with submucosal diathermy to inferior turbinates improves symptoms at months postoperatively in a study of one hundred and one patients septoplasty for nasal obstruction due to a deviated nasal septum in adults: a systematic review suturing of the nasal septum after septoplasty, is it an effective alternative to nasal packing? clinical outcomes of nasal septal surgery at high altitude revision septoplasty: a prospective disease-specific outcome study septoplasty with concomitant inferior turbinate reduction reduces the need for revision procedure outcomes of septoplasty a randomised clinical trial of turbinectomy for compensatory turbinate hypertrophy in patients with anterior septal deviations a randomized clinical study: outcome of submucous resection of compensatory inferior turbinate during septoplasty quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: protect (prostate testing for cancer and treatment) study. commentary: presenting unbiased information to patients can be difficult optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the quintet recruitment intervention (qri) outcomes after nasal septoplasty: results from the nasal obstruction septoplasty effectiveness (nose) study. otolaryngol head neck surg development of a severity classification system for subjective nasal obstruction psychometric validity of the -item sinonasal outcome test the sino-nasal outcome test (snot): can we make it more clinically meaningful? otolaryngol head neck surg does septoplasty enhance the quality of life in patients? prevalence of sinonasal outcome test (snot- ) symptoms in patients undergoing surgery for chronic rhinosinusitis in the england and wales national prospective audit functional and cosmetic outcomes of external approach septoplasty is the sino-nasal outcome test- a suitable evaluation for septorhinoplasty? evaluation of benefits of nasal septal surgery on nasal symptoms and general health gender-specific differences in chronic rhinosinusitis patients electing endoscopic sinus surgery can the sino-nasal outcome test (snot- ) be used as a reliable outcome measure for successful septal surgery? assessment of subjective scales for selection of patients for nasal septal surgery the estimation of a preference-based measure of health from the sf- the use of nasal spirometry as an objective measure of nasal septal deviation and the effectiveness of septal surgery use of peak nasal inspiratory flowmetry and nasal decongestant to evaluate outcome of septoplasty with radiofrequency coblation of the inferior turbinate the accuracy and reproducibility of rhinospirometry in detecting flow asymmetry in a nasal cavity model the value of bilateral simultaneous nasal spirometry in the assessment of patients undergoing septoplasty spirit explanation and elaboration: guidance for protocols of clinical trials nasal septal surgery: evaluation of symptomatic and general health outcomes patterns of treatment effects in subsets of patients in clinical trials reporting attrition in randomised controlled trials practice based, longitudinal, qualitative interview study of computerised evidence based guidelines in primary care the national randomised controlled trial of tonsillectomy in adults (nattina): a clinical and cost-effectiveness study: study protocol for a randomised control trial distributed decision making: the anatomy of decisions-in-action clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials capturing users' experiences of participating in cancer trials evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit a feasibility study incorporating a pilot randomised controlled trial of oral feeding plus pre-treatment gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in patients undergoing chemoradiation for head and neck cancer (tube trial): study protocol the constant comparative method of qualitative analysis the quality of qualitative research. london: sage constructing grounded theory: a practical guide through qualitative analysis it's not just what you say, it's also how you say it: opening the 'black box' of informed consent appointments in randomised controlled trials a simple technique to identify key recruitment issues in randomised controlled trials: q-qat-quanti-qualitative appointment timing outcomes of septal surgery a systematic review of training programmes for recruiters to randomised controlled trials springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors would like to thank the nairos site principal investigators for their continuing input into the nairos trial. nairos authors' contributions sc is the trial chief investigator and senior author. sc, jo'h and jaw led the funding application and protocol development. ds was the trial senior statistician during the funding bid and advised on trial design. dh is the trial senior statistician and advised on trial design, and leads on the statistical analysis plan. tf is the trial statistician. lt is the senior health economist, yo is the health economist, nr is the senior qualitative researcher and lr leads the quintet recruitment intervention. dwh contributed to the ppi for the funding bid. as, kjr, a-mh, e-mh and aa provided trial and database management and trial monitoring. md and ab developed the pnif and npr measurement protocols. kjr drafted the manuscript for this publication. all authors contributed to protocol development. all authors have revised the manuscript and given approval for the final version. this trial is funded by a national institute for health research health technology assessment programme grant (funder reference / / ). the funder did not contribute to this manuscript, but provided review and approval prior to submission for publication. data-sharing is not applicable to this article as no datasets were generated or analysed for this article. the main pis and main informed consent form are presented as additional files and , respectively.ethics approval and consent to participate conduct of the trial will be in accordance with the recommendations for physicians involved in research on human subjects adopted by the th world medical assembly, helsinki and later revisions. informed, written consent will be given by all participants prior to any trial screening procedures and participation in the trial.a favourable ethical opinion has been granted from the uk health research authority research ethics committee (north east -newcastle and north tyneside ; study reference approval number /ne/ ). as per the uk hra process, this central rec review is applicable to all trial sites; local ethical review is not required. we will not commence recruitment at sites until local research and development confirmation of capacity and capability is received. the trial has also received approval from the uk medicines and healthcare products regulatory agency (mhra; study reference number - - ). the trial has been included in the national institute for health research clinical research network (nihr crn) portfolio (nihr clrn study id: ). the trial sponsor is the newcastle upon tyne hospitals nhs foundation trust, freeman hospital, freeman road, high heaton, newcastle upon tyne, ne dn. the trial sponsor has delegated responsibility for trial management to nctu, including trial design; review and approval of all localised patient-facing documentation prior to implementation at each site; collection, analysis and interpretation of data; writing of the protocol publication and final clinical report manuscripts. the sponsor did not contribute to this manuscript, but provided review and approval prior to submission for publication. not applicable. the authors declare that they have no competing interests.author details key: cord- -l ulr ep authors: freeman, shannon; marston, hannah r.; olynick, janna; musselwhite, charles; kulczycki, cory; genoe, rebecca; xiong, beibei title: intergenerational effects on the impacts of technology use in later life: insights from an international, multi-site study date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: l ulr ep as the use of technology becomes further integrated into the daily lives of all persons, including older adults, it is important to investigate how the perceptions and use of technology intersect with intergenerational relationships. based on the international multi-centered study technology in later life (till), this paper emphasizes the perceptions of older adults and the interconnection between technology and intergenerational relationships are integral to social connectedness with others. participants from rural and urban sites in canada and the uk (n = ) completed an online survey and attended a focus group. descriptive and thematic analyses suggest that older adults are not technologically adverse and leverage intergenerational relationships with family and friends to adjust to new technologies and to remain connected to adult children and grandchildren, especially when there is high geographic separation between them. participants referenced younger family members as having introduced them to, and having taught them how to use, technologies such as digital devices, computers, and social networking sites. the intergenerational support in the adoption of new technologies has important implications for helping older persons to remain independent and to age in place, in both age-friendly cities and in rural communities. the findings contribute to the growing literature in the fields of gerontology and gerontechnology on intergenerational influences and the impacts of technology use in later life and suggest the flexibility and willingness of older persons to adopt to new technologies as well as the value of intergenerational relationships for overcoming barriers to technology adoption. from monitoring personal health and wearable devices to playing online games and using social media to connect with friends and family, technology has become a valued component of daily life for many individuals. interest in technology has steadily increased over the past decade, associated with unprecedented growth and innovation in information and communication technologies (icts) [ , ] . there has been an increase in the proportion of older adults (persons aged over years) in countries across the world utilizing technology [ ] . as the use of technology and associated icts increases, there is a greater need to expand the understanding of the intersection of technology, ageing, and intergenerational relationships. a particular gap in knowledge exists regarding the role of intergenerational elements in motivating older adults to learn how to use technology and associated icts. across the globe, societies are aging rapidly due to increased life expectancy as a result of better health and social care, and lower birth rates [ ] . recent united kingdom (uk) population estimations suggest the proportion of those aged + years in rural and urban environments will increase by % between and , whilst those aged < years are projected to increase by eight percent in urban areas and to stagnate in rural locations [ ] . in , . % of the canadian population, equating to over million persons, were aged , and it is predicted that by , older adults will exceed . million persons, accounting for % of the canadian population [ ] . in canada, the majority of older adults ( . %) lived with a spouse or a common-law partner in while about one-quarter ( . %) lived alone [ , ] . the increase in the migration of younger cohorts from rural to urban areas and of older adults from urban to rural areas leaves an increased proportion of older adults in rural areas who prefer to "age in place" [ , ] . research focused on aging in urban areas has emphasized the challenges older adults face in accessibility, especially in access to public transportation, shopping, and green space [ ] . as geographic separation between family members increases, the role of icts in helping to strengthen and maintain family bonds becomes more important [ ] . however, the extent to which older adults use technologies for this purpose remains unclear. although, in the future, aged cohorts may be more "tech savvy" [ ] , having used technologies regularly across their life course, new technologies may still arrive that could be disproportionately challenging for older people to adopt. technology (e.g., digital devices, the internet, digital gaming, and mobile apps) use in later life is a growing field of research, with much new exploration and study [ ] [ ] [ ] [ ] . technology and associated icts are often aimed towards improving the health, wellbeing and quality of life of older adults, whether through applications for home healthcare and connected health services [ ] , medication reminders [ , ] , mirrors that display health data [ ] , or wearable technology [ ] . technology use to enhance communication is routine practice for many older adults, with home computers being used to create a common interest among older and younger family members and improve family ties [ ] . technology use among older adults is growing [ ] . for example, in canada, between and , internet use increased from % to % among those aged and older [ ] . in , % of people aged - used the internet compared to % of those aged - and % of those aged years and older [ ] . challenges with technology have been linked to age, evidenced by differences in use [ , ] and variation in the learning of technology (computers and internet) between older and younger adults [ , [ ] [ ] [ ] [ ] [ ] [ ] . older adults in canada were less likely than younger adults to perceive technology as useful for communicating with others, making informed decisions, and saving time [ ] . several studies reported that internet use is lower among older-aged cohorts than younger cohorts [ ] [ ] [ ] ; however, there is evidence of a cohort effect as there has been an increase in technology use within older-aged cohorts over time [ ] . older adults who do use the internet report lower confidence in their ability to do so than younger adults [ ] , which may be tied to challenges older adults experience with technology use (e.g., visual difficulties and cognitive declines) [ , ] . older adults are likely to make more errors and require assistance when learning computer systems and software [ , ] . previous research suggests that older adults may be "technophobic" [ , ] and struggle to use technology [ ] , as they embrace technology differently and at a slower pace than younger adults [ ] , [ , ] . as the canadian and uk populations age, differences in technology adoption and use across age cohorts may increase, amplifying the "generational gap" [ ] . while learning to use technology serves as a rite of passage for today's youth, playing an important role in the self-definition of young adults [ ] , this may not be the case for older generations. individuals not born into the current rapidly evolving digital age, sometimes referred to as "digital immigrants", must find ways to adapt to a changing society [ ] . rama noted that each "technology generation" may have been affected by common experiences during their formative years that influence behaviours towards and the use of technology [ ] . however, these notions are challenged by bennett and maton, who note the diverse range of experience and engagement with technology among youth, as well as by loos, who describes technology use as a spectrum affected not only by life stage but also by socialization and degree of age-related functionality [ , ] . technology use is complex and can no longer simply be split into user vs. non-user groups. instead, the heterogeneity in the use of technology includes not only use of the technology for an intended purpose but also the meaning and value that the use of technologies has in mediating social relationships and connection to the external world [ ] . existing research highlights differences in technology use between the generations; however, research on the connection between intergenerational factors, social variables, and technology use among older adults is less prevalent, with notable exceptions including [ ] [ ] [ ] . however, other research suggests that age is not a consistent driving factor associated with aversion to technology such as computer anxiety [ ] . as such, it remains less clear how factors such as intergenerational intelligence, solidarity, and adaptiveness apply to the learning and use of technology, especially by older adults [ ] [ ] [ ] [ ] [ ] . younger generations are the dominant early users and adopters of social networking sites [ , ] , with few older adults (between % and %) using this form of technology [ , ] . social networking and other technologies present opportunities for older generations to connect with younger generations and individuals in diverse geographic locations [ , [ ] [ ] [ ] . technology has been shown to enhance an older adult's quality of aging [ ] , independence [ ] , social status [ ] , interpersonal relationships, control, self-esteem, and integration into society [ , ] . to understand how to meet the needs of an aging population in a technology-suffused society, it is useful to understand why older adults choose (or not) to use technology and whether (or not) they perceive the reasons driving their choice as constraints requiring negotiation or benefits to everyday life. the challenges to acquiring new technology skills and strategies for connecting with younger generations to overcome them suggest the importance of intergenerational influences on older adults' understanding and use of technology, which must be further explored. the above findings are concerning in light of research reports that older adults are more likely to experience loneliness and isolation [ ] . there is, to date, a growing body of scholarly work exploring the relationships between intergenerational relationships and technology [ , ] , offering insight into how technology and associated icts lay within and across intergenerational networks. taipale and colleagues [ ] discuss ict use through various lenses including both older and younger adults-a generational perspective, the family, and the home. to further extend research in this area, we describe further the relationship between technology use and interpersonal relationships-more specifically, the how older adults' understanding and use of technology is affected by their intergenerational relationships. the technology in later life (till) study examined the experiences of older adults aged + years with technology, exploring how they adopted, accepted, and used various types of technology. subsequently, the team sought to identify the implications of using icts for current and future aging populations in rural and urban locations. the technology in later life (till) study was an exploratory study conducted in canada and the uk across four study sites. canada and the uk were selected for this study as they both have aging populations and exposure to technology and contain different rural and urban populations. in each country, two sites were selected: one rural and one urban. the rural site in canada was the town of mcbride (bc), and the urban site selected was the city of regina (sk). the rural sites in the uk included the village of cwmtwrch and the village of ystalyfera in wales, and the urban site was the town of milton keynes (buckinghamshire) in england. participants were recruited through the use of posters and mailing list scripts tailored to each site distributed to local organizations including the older people's forum, seniors' centers, public libraries, seniors' community newsletters, and local public radio. participants were also recruited through word of mouth in the community. participants each voluntarily contacted the lead investigator for the research site closest to them to request to participate in the study. upon contact, the participants were sent an email containing a link to the online survey, information on the study and a request for written consent to participate, and an invitation to set a date to join a focus group interview. all participants completed the online survey prior to participation in a focus group. the survey was an iteration of an earlier survey [ , ] , which covered eight domains: ( ) technology use, ( ) internet ownership and use, ( ) social networking, ( ) digital device ownership, ( ) purchasing patterns, ( ) quantified self-and life-logging, ( ) information sharing and privacy issues, and ( ) demographics. bivariate analyses of the survey data were conducted using spss version . an inductive approach was taken to generate new knowledge from the qualitative data. a descriptive approach is beneficial for an initial study, as such an approach allows the researchers to richly describe the phenomenon being studied. focus group discussions, led by the lead researcher from each site, lasting between and minutes, were digitally audio-recorded and then transcribed verbatim in microsoft word by a uk-based transcription company. all the lead researchers were experienced in conducting qualitative research analyses and in leading focus groups. a semi-structured interview guide containing questions and probes was used to facilitate discussion (supplementary materials). the questions examined several areas including the ownership of technology, the purpose for using technology, internet social media use, life-logging, privacy issues and the sharing of information (e.g., what type of information and rationale for sharing), and willingness to embrace new technology (supplementary materials). content and inductive analyses [ ] were conducted across all the transcripts. given the exploratory nature of this analysis, the transcriptions were read closely for familiarization with the data, coded, and analyzed thematically. the data were classified into categories as a way of describing key themes [ ] . in addition, areas of concordance and discordance were examined through the analysis. specifically, open coding, with the creation of categories and abstraction, was undertaken. coding was first conducted independently by a research assistant, trained in qualitative research methodologies and experienced in conducting analysis, and by a co-investigator, both of whom then came together to come to a consensus on the coding. discrepancies were addressed by recoding areas of discordance, and then, the transcripts were reanalyzed by the research assistant and reviewed by a co-investigator of the study to promote accuracy and trustworthiness [ ] . ethics approval was granted by all four institutions. thirty-seven participants both completed an online questionnaire and attended a focus group discussion. this included rural participants (mcbride, canada, n = , cwmtwrch and ystalyfera, uk, n = ) and urban participants (regina, canada, n = and milton keynes, uk, n = ) from to . most participants were female ( . %), retired/not employed ( . %), and in their late s (mean age, . years). five themes were identified relating to intergenerational relationships. three themes focused on the benefits of intergenerational relationships to support use of technology including ) motivation for older adults to use technology, ) use of technology as a facilitator of intergenerational connection and ) technology use for safety reasons. additionally, two themes focused on the impediments of intergenerational relationships to use of technology including ) using technology to appease younger family members; and ) learning how to use technology in later life. all participants used technology, the majority of whom did so on a regular basis (table ) . nearly all participants used a computer ( . %) and owned a computer ( . %). most participants had used a computer for at least years ( . %) and used a computer more than once per day ( . %). all participants used a digital device, typically a mobile/cell phone ( . %), and to share information ( . %). nearly all participants identified having internet at home ( . %) and most had used the internet for more than years ( . %). participants used technology for a variety of tasks including e-mail, word processing, playing games, making telephone calls, online shopping, online banking, sharing information, social networking, searching/checking information, instant messaging, reading, uploading content, and lifelogging. over half reported using social media ( . %, n = ) with more canadian participants' self-reporting use of social media when compared to participants from the uk ( . % vs. . %) ( table ). a primary motivation for participants to use technology was as a "digital gathering place" to communicate with family, especially adult children and grandchildren, and friends. participants communicated through technology in a variety of ways including skype, facetime, e-mail, social networking sites (e.g., facebook), and texting through cellular networks or whatsapp. interestingly, it was common that participants who used technology were taught how to do so by younger family members. the value of digital communication was enhanced when participants' children and/or grandchildren lived far away. "skype is brilliant. i've got a daughter in spain, i've got a granddaughter in spain, i've got a son in the west indies and a daughter in london, and skype is one of the most brilliant things that's happened because you can see, you can talk." [mk , male]. "i've used skype because my daughter lives in south africa, but it's an atrocious service because south african broadband is atrocious. we now use apple facetime and that is far superior." . it is also useful to note that participants adjusted the platforms they used not only due to personal preferences but also in response to the variance in the infrastructure and broadband support across the locations. older adults reported using technology to connect with friends and family members, and to share information, also likely with family members. participants often used computers for email ( . %) and social networking ( . %), most often in their own home ( . %) and occasionally at an adult child's home ( . %). social networking sites were used to stay connected with children and/or grandchildren and friends, to share photos and information with friends and/or family, and to keep up to date with news. the internet was used for sending/receiving e-mails, social media, making phone calls through skype/viber, and instant messaging. older adults both created and sent content (e.g., photos and emails), as well as receiving content. it was both older adults and their family members/friends who took turns initiating contact. most participants identified that they used technology to write or speak with other family members; there were a few instances where participants reported using technology to partake in and share the hobbies of younger family members. older adults were keen to try new things with their grandchildren such as interactive videogames and immersed themselves in the flow of the games. one participant noted, "[ . . . ] jumping up and down to the things that they've got on the screen when you play tennis or jump up and down and dance, or whatever you're chasing, something. yes. video games, i suppose. childish ones." [mcb , female]. another participant used her daughter and granddaughter's ipad to take pictures of the community garden. participants suggested that technology is not only used to connect and communicate with younger family members but also to learn about and actively participate in activities with younger generations. of the participants using technology to stay in contact with family, some also acknowledged having started using a digital device for safety reasons at the suggestion of another family member, commonly an adult child. most participants reported owning a mobile device or cell phone, many of whom owned these devices for "safety" [regina , female] and "emergencies only" [mk , female]. one participant living in rural british columbia described how they started using a digital device specifically for driving purposes as well as feeling the need to maintain a sense of peace with their adult children. "i got the cell phone because my kids kept thinking something was going to happen to me. i said, "well you know if i have a breakdown on the highway, we managed for years for god's sake by just stopping someone and they'd help you. but now, "oh my god they could murder you." so, this was supposed to be a safety element to keep peace in the family." [mcb , female]. this participant further described displeasure with the cell phone because it cost them money each month and they never used the device. several participants identified that they got digital devices at the suggestion of an adult child after having suffered a health scare. for example, when asked why they got a cell phone, one participant replied, "oh, well it was the bright idea of my son. i had a mini stroke . . . ever since, but they're [kids] always frightened . . . of a recurrence. so, my son gave me a cell phone, his old one, which i used right away, or more or less. i think, they decided that i should have one, because i did get a few dizzy spells. so, now i just use it" [mcb , female]. even though it was often a younger family member, such as an adult child, who suggested the participant carry a digital device for safety-related reasons, most participants had positive perceptions of using technology for such reasons. for example, one participant spoke positively of how they wore a certain piece of technology that they can press in an emergency situation to notify a family member or emergency service that help is needed. while it seems that most participants use technology to keep in touch with younger family members, the reasons for this contact vary, from safety and emergency situations to routine check-ins with children and grandchildren. in some instances, participants seemed to use technology to make a younger relative happy even if they did not seem to need the technology. for example, "i don't even have an iphone or ipad so i'm really out of date . . . i will get more modernized so that my children will be happy" [regina , female]. another participant stated, "i've got a tablet that i was to take away with me because my grandchildren said it would be useful to have and i wouldn't be using theirs whenever i'm away on holiday with them. i don't get on terribly well with a tablet . . . " [mk , female]. common responses for why participants owned technology included similar motivations, stemming from the children: " . . . the kids decided we should have one [computer]" [mcb , male] and that their grandchildren were putting pressure on them to keep up with the latest technology. furthermore, one participant explained that they were learning technology because the " . . . grandchildren push me and they go, 'oh nana, you're so far behind, you should be up to date and you should be doing this and doing that.' so, they want me to be up to date with all the latest technology and i'm not." [regina , female]. in certain cases, younger family members purchased technology for older family members as gifts. one participant reflected on a life logging device they owned, explaining, "my daughter bought it for my birthday . . . " [wales , female] after her husband began experiencing a health decline. these examples illustrate, across the different study sites, how the respective participants felt about technology and how digital devices had been implemented into their lives without consideration of their respective feelings, needs, and choice. many participants used computers as integral components of their jobs decades ago and were among the early adopters of computing technologies. one participant who was familiar with computers explained that they used to do it at milton keynes college. similarly, a participant from mcbride learned the fundamentals of using a computer for their accounting position, explaining that they learned about spreadsheets. however, with the rapid pace of technology development, the technological skills participants had employed prior to retirement became quickly outdated. participants described that the challenges in keeping up with the rapid pace of changes in the technology itself were compounded by their frustrations in keeping up to date on the expanded language used to describe the technologies. participants described the complexity in language and terminology used in technology tutorial classes and instruction manuals as too complicated and inhibiting their ability to adopt new technologies. one participant identified that instructors at computer classes "go way too fast for me. i can't keep up; there is too much new information . . . the language like computer and technological language is totally different from what we were raised with" [mcb , male]. another participant identified similar grievances about learning to use technology, such as the fact that they "can't understand technology words" [mcb , female] in instruction manuals and that when speaking with information technology (it) specialists, the it specialist would explain too quickly. although participants noted how they were confused about how to use technology, they still managed to do so, most commonly with assistance from younger family members. participants were frequently introduced to digital devices and to social networking sites by a relative or adult child. participants alluded to younger family members playing a key role in the learning process, saying things such as "my son set it [skype] up . . . " [mk , female] and "oh, my daughter is the one that does all the computerizing. she helps . . . " [mcb , female]. they emphasized that they were not technophobic or averse to use of the technology itself but felt outpaced by the speed of change of technology. for many, they were unable to overcome the language barriers created to adapt and adjust to changes in technology on their own or with those of a similar age. instead, they would connect with younger generations for help. where confusion over technology existed, younger family members took on a teaching role, especially for newer technologies such as digital devices and social networking programs. "i ask my grandchildren. 'okay, how do i do this?' they say, 'don't you know?' but they will help me eventually" [regina , female]. younger generations were able to bridge the technology gap and communicate complex language in lay language that was non-threatening. "anything i want to know, i have to phone up my sons or my grandchildren because they're a lot more knowledgeable than i am . . . " [mk , female]. even after being introduced to technology and learning how to use it, participants continued to contact their adult children and other relatives for assistance when faced with difficulties. for instance, one participant stated that "my son is an it expert. if i have any problems, 'can i speak to the it man please.' he knows it's me. he sorts my problems" [mk , female]. some participants seemed to solely rely on younger family members for information when necessary. for instance, one participant concluded, "if i need to know something, i will get my daughter to look it up on her, whatever thing she packs in her pocket" [mcb , male]. for many older adults, intergenerational relationships are leveraged to support the understanding and use of technology. the challenges in the adoption of and adaptation to the rapid developments in digital technologies facilitate opportunities and meaningful purposes for participants to connect and communicate with younger generations. the leveraging of technologies, including social media and virtual communication platforms, supported older adults in maintaining and enhancing social connections, especially with adult children and grandchildren who lived in different cities and countries. these findings support the idea that the use of digital technologies can enhance social connectedness across generations; as taipale noted, "[ . . . ] distributed families can today nevertheless remain connected and feel a sense of togetherness, even when their members are not physically close to one another" [ ] . the benefits of intergenerational relationships for technology, including motivation for older adults' use of technology and the use of technology as a facilitator of intergenerational connections, underlie each domain of the who checklist of essential features of age-friendly cities [ ] . furthermore, this reinforces the need for a revised smart age-friendly ecosystem framework as coined and posited by marston et al. [ ] , who proposed an extension, noting that these features also apply to the rural, and non-urban, context. the desire to mitigate the digital divide fuels older adults' motivation to invest time in building and fostering intergenerational digital connections. previous research similarly suggests that computers are commonly used by older adults as a method of communication with younger generations, serving as a gateway to the world of younger family members and a means to strengthen relationships [ ] . studies show that individuals will often play games, not because of enjoyment of the game itself, but because of the social interaction with others with whom they are playing [ ] . therefore, when creating an age-friendly environment or helping older persons to age in place, it is worthwhile to challenge those designing built environments to consciously address how they may seize opportunities to effectively and efficiently leverage icts to facilitate intergenerational engagement. older adults leveraged technology to connect, communicate, and actively participate in the interests and hobbies of their adult children and grandchildren in online formats, including digital gaming and photography. participants encouraged and enjoyed interacting with younger family members to learn about different technologies (e.g., digital games) as a way of immersing themselves in the culture of younger generations. as previous research illustrates, participants in this study were using digital games as a "computational meeting place" that supported meaningful social interactions and shared motivation for group gaming [ ] . further evidence shows that gaming technologies foster intergenerational group interactions of up to four generations, including adult children and extended families [ ] . our study revealed findings similar to those noted above but for multiple digital technologies, which suggests a more universal and generalizable use of technologies among older adults to increase intergenerational family social interactions as a "digital gathering place". health limitations, the costs of transportation, and social isolation can create barriers for travel, all of which might explain why communication technologies such as skype were often used to connect with family members. these technologies can come close to replicating the face-to-face experience of conversing with another person and are an effective communication method to use when travel is not an option. the extended value of the support of intergenerational connection may be further amplified given the context of covid- and in the post-covid- context. language and terminology often impede the ability of older adults to learn how to use technology. this disconnect and incomplete understanding of technological language could explain why few respondents identified using social media/networking sites but went on to further indicate they do in fact use this form of technology. this discrepancy in responses may stem from a lack of clarity in the question about what social networking entails for the respective participants, or this may reflect a lack of recognition by older adults that they did in fact use social media/networking platforms. despite these complications, participants were able to use technology and associated icts by learning to do so with their adult children and grandchildren, who were able to translate the jargon and technical terms used in information technology courses into a language that older adults could understand within the context of intergenerational relations. this is consistent with the findings from previous studies showing that adult children often initiate the technology use process for older adults and that extended family members (such as grandchildren) are important educators for older adults as they learn to use technology [ ] [ ] [ ] [ ] [ ] [ ] . intergenerational informal education between those with existing relationships may be more effective for knowledge/information exchange. when considering why adult children and grandchildren were common educators, there are a few ways to explain this finding. first, older adults might feel more comfortable learning from family members due to feelings of trust. second, as it was often adult children and other relatives who introduced participants to technology, it makes sense that they would be the ones providing the lessons and education. third, participants may have been learning from younger generations because they may have a greater knowledge of technology, having grown up in the information age. fourth, older adults might choose to learn from younger family members as they use less confusing terminology (compared to user manuals or classes) and they are comfortable enough to ask questions. many older adults in the present study used technology comfortably and were among the early adopters of computers and technology. the role younger generations play in guiding and motivating older adults to use technology may contribute to family cohesion and strengthen relationships. this supports the notion of the "change in family roles" put forward by taipale [ ] , who highlighted the variance of perception between italian and slovenian contexts. nearly all participants reported using a computer at their own home, but other locations such as an adult child's home were also identified. studies have shown that, among older adults who use computers, a majority do so in the comfort of their own home, although computers are also used in public locations such as at work, in a library, or at a friend's/family member's home [ , , , ] . computers might be used at an adult child's home because this is where the learning and introduction to technology take place. however, this pattern of usage could also be indicative of locational convenience, access to computers, privacy issues, what the computer is being used for, or another combination of variables. these preliminary findings point to the importance of investigating further how these intergenerational factors influence the location of technology use. even though participants highlighted the many benefits and uses of technology, some participants remarked on the drawbacks and risks of living in the digital age. the finding that older adults often chose to use computers for leisure to share information and communicate, whereas cell phones were often used to appease worried children, suggests both positive and negative associations of technology. for instance, surveillance and privacy issues, along with digital crime, are risks of using certain technologies [ ] . despite the existence of privacy legislation, there exist privacy threats with the use of technology, such as the tracking of personal information, profiling, and privacy-violating interactions [ ] . despite voiced concern over privacy issues, participants continued to use technologies because of the benefits, such as bridging geographical distances to communicate with younger family members. as such, it seems the rewards outweigh the risk for older adults to use technology. nonetheless, the acknowledgment of such risks by participants draws attention to the importance of providing clear education communicated in lay language on how to safely use technology. this research specifically addressed intergenerational elements of technology use among individuals in both rural and urban areas in two countries. research often overlooks social elements of technology use, viewing technology engagement as a solo activity. a strength of this study is the combination of an in-depth online survey and focus groups, which allowed for a deeper understanding of the topics being studied. upon further validation, the survey could be used in future studies as a standard measure of technology use, social media habits and behaviour, information sharing, and privacy issues. given the exploratory nature of the study, a small sample was acceptable as the aim was for each site to recruit participants. although our sample sizes enabled us to reach saturation of information, a larger sample is needed to confirm our findings. differences in the recruitment methods across sites may have contributed to the difficulties of achieving the targeted number of participants. future studies should recruit participants who use and who do not use technology to compare and contrast their behaviours and identify further barriers to and enablers of technology use in later life. further investigations may extend this work to examine the intersection of technology and intergenerational relationships among older adults who are aging without family to expand the understanding of the roles that peers, friends, or even siblings play in comparison to that of adult children [ , ] . at a time when technology development and population aging research are prevalent, it is vital to capitalize on opportunities to learn about how technology can be used and deployed to increase social connectedness, improve the quality of life of older adults, and support aging in place. with rapid technological developments occurring, there are great opportunities to expand the understanding of gerontechnology and human-computer interaction from a multi-disciplinary standpoint. technology has the potential to play an integral role in ensuring all attributes complement each other and keep knowledge up to date. many participants used technology to maintain social connectedness with younger family members who were geographically dispersed. the findings from this study provide insight into the strengths and opportunities that technologies provide to older adults. understanding how intergenerational relationships impact technology use in later life can inform further research and technological and social practices. tech adoption climbs among older adults. pew research center media use in the european union older adults and technology use world population prospects: the 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among midlife and older adults: an aarp bulletin poll digital crime and digital terrorism privacy in the internet of things: threats and challenges the lived experience of older involuntary childless men ageing without children, gender and social justice we would like to thank all participants who agreed to take part in this study across the different study sites. the authors declare no conflict of interest. key: cord- - f r nv authors: lang, ariel j.; casmar, pollyanna; hurst, samantha; harrison, timothy; golshan, shahrokh; good, raquel; essex, michael; negi, lobsang title: compassion meditation for veterans with posttraumatic stress disorder (ptsd): a nonrandomized study date: - - journal: mindfulness (n y) doi: . /s - - -z sha: doc_id: cord_uid: f r nv compassion meditation (cm) is a contemplative practice that is intended to cultivate the ability to extend and sustain compassion toward self and others. although research documents the benefits of cm in healthy populations, its use in the context of psychopathology is largely unexamined. the purpose of this study was to refine and initially evaluate a cm protocol, cognitively based compassion training (cbct®), for use with veterans with ptsd. to this end, our research team developed and refined a manualized protocol, cbct-vet, over sets of groups involving veterans. this protocol was delivered in – sessions, each lasting – min and led by a cbct®-trained clinical psychologist. quantitative and qualitative data were used to identify areas to be improved and to assess change that occurred during the treatment period. based on pooled data from this series of groups, cm appears to be acceptable to veterans with ptsd. group participation was associated with reduced symptoms of ptsd (partial eta squared = . ) and depression (partial eta squared = . ), but causality should not be inferred given the nonrandomized design. no change was observed in additional outcomes, including positive emotion and social connectedness. the results of this open trial support additional exploration of cm as part of the recovery process for veterans with ptsd. although empirically supported treatments are available for posttraumatic stress disorder (ptsd), most military personnel and veterans choose not to engage in these treatments or have residual symptoms after treatment completion (steenkamp et al. ) . a growing literature suggests that meditation may be useful in recovery from ptsd (see lang et al. for a review). data from clinical and non-clinical samples suggest that compassion meditation (cm) has a positive impact on positive emotion and social functioning, which are areas of difficulty for many individuals with ptsd. nonetheless, cm has yet to be evaluated for treatment of ptsd. cognitively based compassion training (cbct®) is a cm training program. it consists of a sequence of contemplative practices that are believed to cultivate the ability to extend and sustain compassion toward self and others (negi ) . cbct® combines present-moment practices (i.e., focused attention and open monitoring) with analytical contemplative methods, which encourage cognitive reappraisal and alteration of usual mental patterns to expand compassion. cm and similar approaches (e.g., loving kindness meditation [lkm] ) lead to increases in positive emotion in both clinical and nonclinical samples (for a recent meta-analysis see zeng et al. ) . the first published clinical application showed that lkm increased positive emotion and decreased negative emotion among individuals with negative symptoms of schizophrenia (n = ; johnson et al. ) . more recently, an open trial with veterans with ptsd (n = ) found that lkm was associated with decreased symptoms of ptsd and depression (kearney et al. ) , increased unactivated positive emotions, and decreased both activated and unactivated negative emotions (kearney et al. ). finally, evidence from functional mri shows activation in areas typically associated with positive affect (left medial prefrontal cortex and anterior cingulate gyrus) in an expert meditator engaged in cm (engstrom and soderfeldt ) . compassion-based meditative practices have also been suggested to alter social functioning in nonclinical samples. brief lkm practice was associated with a greater sense of social connectedness and positivity toward others based on explicit and implicit reactions in a laboratory setting (hutcherson et al. ). cm has also been linked to increased empathic accuracy and activation of associated brain circuitry (mascaro et al. ) , as well as increased altruistic behavior (galante et al. ; weng et al. ) and activation of brain regions associated with social cognition and emotion regulation, suggesting greater capacity to understanding the suffering of others (weng et al. ) . it is unknown, however, what effect cm may have on social connectedness in the context of psychopathology. both positive emotion and social functioning are potentially important targets in recovery from ptsd. ptsd is a maladaptive response to exposure to a traumatic event, characterized by unwanted re-experiencing of the event, avoidance, negative cognitive appraisals, and hyperarousal (american psychiatric association ). in addition to strong negative affect, ptsd is characterized by deficits in positive affect (litz and gray ) and avoidance of positive affective stimuli (clausen et al. ) . the importance of cultivating positive emotion is suggested by fredrickson's ( ) broaden and build theory, which posits that positive emotions enhance the ability to think flexibly and thereby build psychological resources that enable successful coping. in this way, positive emotions are believed to counteract the deleterious effects of negative emotions (fredrickson ) . high positive emotionality and intentionally inducing positive emotion have been associated with resilience, i.e., the ability to recover from negative experiences and to change based on situational demands (tugade and fredrickson ) and the ability to cope with highly stressful events (fredrickson et al. ) . thus, positive emotion induced by cm may independently reduce dysphoria, which appears to be the best predictor of problems in psychosocial functioning among those with ptsd (pietrzak et al. ). in addition, positive emotion has been shown to reduce fear-based reactivity (fredrickson et al. ) so may ameliorate ptsd-related anxious responding and hyperarousal. finally, positive emotions cultivated in cm may enhance one's ability to take another's perspective and foster closeness, thus providing social reinforcement and support. sharing of positive events, rather than providing support during negative events, is predictive of relationship health (gable et al. ) . problems with social functioning also are common among those with ptsd. individuals with ptsd have diminished ability to empathically connect with others (nietlisbach et al. ) and demonstrate poorer marital and family functioning and more impairment in interpersonal relationships and social activities (schnurr et al. ). social impairment is a predictor of chronicity of the disorder (marshall et al. ) , has been linked to increased risk of suicide for ptsd patients (panagioti et al. ) , and predicts return for additional care after initial treatment (fontana and rosenheck ) . social support, on the other hand, has been shown to buffer against development of ptsd and to predict improvement (e.g., ozer et al. ) . a greater sense of social connection is associated with better psychological and social functioning (hagerty et al. ) , including reduced anxiety and greater selfesteem (lee and robbins ) , and may have a protective effect against stress, depression, and ptsd (see, for example, cacioppo et al. ; cacioppo and patrick ) . thus, a greater sense of connection to and caring for others as encouraged by this practice may also translate into symptom reduction. for example, higher levels of altruism have been associated with lower levels of symptomatology in veterans with ptsd (kishon- barash et al. ) . the goal of the study presented herein was to adapt and collect preliminary data on the clinical impact of a modified version of cbct® for veterans with ptsd. an iterative refinement process using quantitative and qualitative feedback was used to refine the original cbct® protocol to reflect military/veteran culture and to enhance digestibility of the material and relevance to ptsd. pooled data from this set of groups are presented as an initial index of the feasibility and potential clinical utility of the intervention. participants participants (n = ) were veterans with ptsd who were able to consent and willing to participate. co-occurring disorders such as depression, anxiety, or treated substance abuse or dependence problems were permitted provided that ptsd was the primary presenting complaint as determined by clinical interview. exclusion was on the basis of the following: ( ) high risk for suicide or homicide that required urgent or emergent evaluation or treatment within the three months prior to study entry, ( ) untreated substance abuse or dependence problems, ( ) serious axis i mental disorders, such as psychotic disorders or bipolar type i, or serious dissociative symptoms ( ) cognitive impairment that would interfere with treatment, ( ) current circumstances that involve recurrent traumatization (e.g., currently engaged in a violent relationship), and ( ) concurrent enrollment in any other treatment specifically targeting ptsd symptoms or social functioning (e.g., couples therapy). participants were allowed to continue current pharmacological treatment provided that no additional treatment response was expected and no changes were anticipated during the study period. the enrolled sample included veterans, of whom went on to begin the intervention (refer to fig. for detailed study flow). the enrolled group was mostly male (n = , %) with an average age of . years (sd = . ). the group was also predominantly caucasian (n = , %), with ( %) individuals identifying with more than one race, native american/alaskan native, african-american and native hawaiian/pacific islander; twelve ( %) individuals identified as hispanic. on average, the group reported . years (sd = . ) of education, and eleven ( %) were currently employed. twelve ( %) veterans were married or had a permanent partner. the average number of lifetime traumatic events endorsed was . (sd = . , range - ); the most commonly endorsed events were transportation accidents (n = ), combat (n = ), and physical assault (n = ). the majority (n = , %) had served in the recent conflicts in iraq and afghanistan, but several major deployments since vietnam were represented. twenty-one ( %) individuals reported some type of combat injury, and most (n = , %) were receiving compensation from the va. this study was approved by the institutional review board of the va san diego heathcare system. potential participants were referred to the study by mental health providers or expressed interest directly in response to advertisement. interested individuals came to the clinic to complete informed consent, hipaa authorization, and the initial evaluation for eligibility. consenting, eligible individuals went on to complete the assessment battery. beginning with the first group meeting, weekly measures of ptsd, depression and alcohol use were gathered. the assessment battery was repeated at post-intervention. credibility was measured after the first session and satisfaction after the last session. finally, weekly diaries were used to quantify meditation practice. participants completed - classes, each lasting - min (refer to table for the final schedule). all groups, which ranged in size from to at the start, were led by a licensed clinical psychologist (pc), who completed the cbct® teacher certification program, which includes a week-long retreat/workshop, a supervised practicum experience, and a post-practicum weekend workshop. as part of the practicum, audiotapes of sessions were reviewed by experts in cbct® (th, ln), and weekly supervision was provided to assure adherence to the intervention. intervention cbct® was designed to engender well-being through a set of meditative practices that aim to increase compassion, i.e., the sense of caring for the well-being of others and wanting them to be free from their difficulties and distress. developed at emory university in by professor negi, cbct® is based on techniques from the indo-tibetan buddhist tradition. as a secularized protocol, however, cbct® is independent from and supportive of any faith or belief system. the course is typically taught in weekly meetings supplemented by daily guided meditation recordings. group meetings for this study were structured approximately as follows: welcome agenda setting ( min), homework review ( min), participants' summary of past week's material ( min), didactics ( min), mindfulness exercise incorporating new concepts ( min), meditation incorporating new concepts ( min), homework assignment, and question/answer session ( min). participants were provided with a written manual to facilitate their understanding of the material. homework involved daily meditation practice, which gradually increased from min per day at the beginning to min per day at the end. cbct® includes tools with the explicit aim of expanding compassion to be more inclusive, broadening the sense of in-group, and dampening out-group bias. broadly speaking, the structured sequence of exercises begins with stabilizing attention and developing presentmoment awareness then provides analytical practices to increase well-being and unbiased compassion toward self and others. participants begin by recalling a time or place in which they were safe and taken care of by another to prime a sense of safety and security to sustain this positive affect and increase the awareness of the value of compassion in their own lives. next, participants take part in an attention-training practicefollowing the sensations of the breath as they unfold-to promote attentional stability and mental clarity; a key objective of this is to learn to notice and release (bcatch and release^) distractions as they arise. this increased mental stability then supports present-moment awareness, sometimes called open monitoring. here, the attentional focus shifts to how mental experiences unfold from moment to moment, as the practitioners attempt to neither push away such experiences nor become overly involved in them. this practice improves calmness of mind and provides insight into habitual mental patterns. the stability and insights from these exercises then support the analytical reflections that follow. the next topic is to examine the nature of distress and dissatisfaction in one's life and cultivate more realistic and constructive attitudes in the face of difficult circumstances. with an emphasis on approaching one's situation with increased self-kindness, the practitioner strengthens the determination to replace unhelpful perspectives and attitudes with more constructive ones, thus increasing a sense of self-efficacy and promoting a realistically based optimism. with a greater caring for self and the insight that constructive attitudes and perspectives are essential to enhancing wellbeing, cbct® then focuses on attitudes and perspectives that are directed toward other people. humans are fundamentally social creatures; relating constructively and positively with others is central to anyone's well-being. thus, the participant goes on to examine how all people, despite many differences, share a fundamental desire for being well, flourishing and avoiding distress and dissatisfaction. this practice leads to a greater capacity to see others as like oneself at a basic level, setting the stage for greater empathic response and more inclusive compassion. next, participants spend time reflecting on how their own well-being is dependent on the efforts of others, thus cultivating an appreciation for the received kindness of others, intended or unintended. these teachings are meant to generate authentic gratitude, moderate unrealistic attitudes of independence and isolation, and generate a deepening affection, even for those outside one's social group. the practice concludes with a focus on the arising and sustaining of compassion toward others. here, the participant embraces others as deserving of understanding and care because everyone-including loved ones, but also strangers and even difficult people-has inherent value and the equal right to pursue freedom from suffering. by focusing on the difficulties and distress experienced by so many, a deeper empathic response is evoked, and when supported by the inner strength introduction of positive cognitive reflection into stabilized meditation. superheroes are used as an example of accepting flaws. expecting perfection or self-blaming is a barrier to self-awareness and compassion. introduction to the idea that that all beings want to avoid suffering and find satisfaction in life. clarity in understanding that it is behavior and not humanity that can be inappropriate assists participants in building a more open acceptance of others. session : appreciation and gratitude ordinary objects, talents and skills are shown to have been obtained through the contributions of both known and unknown others. this creates an awareness of interdependence and builds appreciation and gratitude for the human family. in the context of interdependence (i.e., others who do not necessarily like them or even know them are continually helping them to live their everyday life), it becomes easier to see that all people have bad habits. understanding that change is difficult for all people and that we are not completely aware of the underlying issues others have helps participants to wish to relieve suffering for others. session : putting it all together ( ) review and relapse prevention. helps participants to understand the links between the sessions and allows participants to create meditation cards to keep to support coping when they might not have access to guided meditations. personalized meanings of the sessions are shared among members. session : putting it all together ( ) coping cards for applying meditation in everyday actions are created in class. homework exercise reviewed to provide a springboard for brainstorming and understanding. lessons on how to avoid compassion fatigue and continue to build positive emotions are taught. developed earlier in the practice, this empathy is transformed to become an engaged and motivated sense of caring for others and lead to more spontaneous and consistent prosocial thoughts and behaviors. protocol refinement the cbct® program was manualized before the initial group based on clinical experience with veterans with ptsd (ajl, pc, me) in collaboration with cbct developers (ln, th) to create the veteran version, cbct-vet. initial modification was aimed at increasing military/veteran relevance and facilitating use by individuals with psychopathology. the guided meditations encourage emotional experiences and thus could be difficult for individuals with ptsd to tolerate. the therapist spent time in session talking about this possibility and how to handle it and made herself available between sessions as needed. veterans were provided with strategies for managing flashbacks or strong emotions that are consistent with the practice, e.g., taking a deep breath and reseating oneself, then returning attention to the breath. similarly, difficulty focusing could be handled by placing hands on one's belly (to get a physical reminder of breathing) and breathing until the experience passed. in addition, we assumed little to no exposure to meditation to make the program accessible to any veteran with interest, so we developed additional materials to facilitate understanding of meditation. education in the science of compassion, including brief videos to illustrate difficult concepts, supplemented straightforward didactic materials that were provided in the participants' manuals. in addition, we believed that it was important that veterans apply meditation practices to ptsd-relevant experiences, so homework was designed to encourage and help trouble-shoot that process. the language from the original cbct® guided meditations was retained to the extent possible to maintain consistency of the intervention, although adaptations to reflect an th grade reading level and veteran-relevant terminology were important to foster accessibility of the material. in addition, group discussion was used to enhance understanding and application of the material. finally, we were concerned that the group nature of the intervention, which is the standard for instruction in meditation, could create a barrier to individuals who typically prefer one-on-one therapy. on one hand, compassion is often enhanced by exposure to experiences of others shared in the class and veterans can help each other through the struggles and joys of learning meditation. on the other hand, individuals who have experienced trauma are frequently uncomfortable with discussing symptoms or traumatic experiences in a group setting. to manage this concern, potential participants were helped to understand that the focus of the class was learning meditation rather than discussing traumatic events. it is our aspiration, however, that the skills developed in the group will facilitate one's ability to discuss and cope with distressing experiences, such as during trauma-focused psychotherapy. to the extent that traumatic events were brought up by group members, the group leader gently redirected the discussion from trauma specifics to expressing the ways in which they were cognitively or emotionally impacted while meditating. participants were encouraged to remain after class to discuss specific concerns that might not be central to the group's current work, and referrals to additional services were provided as needed. the treatment development team (al, pc, me, th, ln) made subsequent refinements to the manual after the completion of each group based on therapist input, qualitative interviews, and quantitative data. the changes, which were evaluated based on subsequent participant feedback, were as follows. the groups were reduced from to min to reflect participant comments about the group seeming too long. veterans requested more time for group discussion and cohesion-building, so classes were reviewed to balance presenting material and exercises with group process. meditation exercises also were reconfigured to involve paired work or group interaction to foster a feeling of group cohesion while maintaining the integrity of the intervention's goals. to address perceived deficits in conceptual understanding of the intervention that we identified in the qualitative interviews, veterans were asked to bteach^previously presented concepts to other group members with others being encouraged to chime in if there were other items that might facilitate learning. the class was extended from sessions to to make up for the change in session length and to allow time for discussion and review/ skill consolidation. one concern that may be unique to this population was that tinnitus was experienced as louder when there were silences in the recorded guided meditations. these participants were reminded that this experience was common for them throughout their lives, that this was their bnew silence,^and that if distracted by the ringing, they could bring their attention back to the breath. finally, some veterans had difficulty accessing the guided meditations because of unfamiliarity with technology. to manage this, study staff took a more active role in providing support. table presents the final intervention outline. demographic information was collected via self-report, and the montreal cognitive assessment (moca; nasreddine et al. ) was used to screen for cognitive impairment. a score lower than the age/education-adjusted cutoff for psychiatric populations (gierus et al. ) triggered additional neuropsychological evaluation and clinician clearance to participate. the mini international neuropsychiatric interview (mini . ; sheehan et al. ) was used to establish psychiatric diagnoses, including primary diagnosis, and to screen for suicide/homicide risk. the dissociative experiences scale (des; bernstein and putnam ) was used to identify problematic dissociative symptoms, and the life events checklist (weathers et al. a ) was used to inventory lifetime trauma exposure. finally, each participant was queried about use of mental health services. issues of clinical concern were further evaluated by clinician review of the electronic medical record. the feasibility of the approach was evaluated based on participant attrition, time spent in practice, credibility as measured by a -item measure adapted from (borkovec and nau ) , satisfaction as measured by the client satisfaction questionnaire (csq- ; attkisson and greenfield ) , and qualitative interview. qualitative interviews were conducted by an experienced qualitative interviewer (sh) with the aim of learning about the understandability, applicability, and efficacy of cm for this group. interviews were conducted by phone within weeks of the conclusion of the last session attended to give participants an opportunity to reflect on their experience and learning. each interview lasted approximately min. the interviews were recorded and notes were taken by the interviewer to capture participant responses. the semistructured interview guide posed nine reflective questions that focused around the (a) experience of practicing cm, (b) potential changes noted from skills they had learned at each intervention session, and (c) personal changes that participants perceived in managing both pleasant and unpleasant situations in their life because of their cm training. clinical outcomes were measured on a weekly basis using the dsm- version of the ptsd checklist (pcl- ; weathers et al. b) , the patient health questionnaire depression items (phq- ; kroenke et al. ) , and the consumption items from the alcohol use disorders identification test (audit-c; bush et al. ) . weekly measures were also used by therapists to monitor participant safety, as is typical practice in ptsd treatment. emotional experience was assessed weekly using the modified differential emotions scale (mdes; fredrickson et al. ) , which consists of daily ratings of the strongest experience of specific emotions in the preceding h. the mdes is scored to quantify positive and negative emotions separately. in addition to the weekly measures, the -item social connectedness scale-revised (scs-r; lee et al. ) and the short form of the self compassion scale (scs-sf; raes et al. ) , which is comprised of six two-item subscales: self-kindness, common humanity, mindfulness, self-judgment, isolation, and overidentification, were administered before and after treatment. the sample description and analysis of clinical change is based on data that were pooled across the four groups of six to eight participants. although there are differences in terms of content and therapy time within the groups, we believe that the aggregated data are informative in terms of our goals of evaluating the feasibility and clinical impact of cbct-vet as the fundamental intervention (cbct®) remained the same. a flowchart was generated to capture the flow of subjects throughout the study (refer to fig. ) . descriptive statistics were used to characterize the participants before treatment. the collection of qualitative data was useful to explore details about participant perceptions of the intervention. specifically, the qualitative data provided a contextual understanding of differences in participants' reactions and how that influenced their adaptability to the dynamics of the intervention, as well as ways in which they negotiated the practice of cm for stressful life situations. descriptive statistics were used to characterize the sample. mixed effects models were applied to measures that were captured weekly, and repeated measures analysis of variance (anova) was used for pre-post change. effect sizes (partial eta squared) were calculated based on the first and last completion of each clinical measure. at the first intervention session attended, participants had a mean pcl- score of . (sd = . ; n = because one participant elected not to complete this measure) and a mean phq- score of . (sd = . ). all had a ptsd diagnosis with the exception of one individual; this person had a primary complaint of subsyndromal ptsd (pcl- = ) with clinically meaningful distress and impairment, so an exception to eligibility criteria was made. the rates of co-occurring diagnoses were as follows: major depressive disorder (n = , %), panic disorder (n = , %), social phobia (n = , %), and obsessive compulsive disorder (n = , %). before treatment, eight people screened positive for potentially problematic drinking behavior based on the audit-c. seven participants had completed one or more empirically supported psychotherapy for ptsd in the past, and veterans were taking one or more psychotropic medication. figure presents attrition throughout the study. eighty-eight percent of those who were assessed for eligibility enrolled in the study; this high rate likely reflects the use of clinician referral and relatively broad eligibility requirements. a significant number ( / ) withdrew before beginning treatment. those who completed six or more sessions (n = , % of those who began treatment) were exposed to the essentials of the intervention, and those who completed four to five sessions (n = ; %) were presented with some concepts but not the full intervention. those who completed - sessions (n = ; %) did not receive a meaningful introduction to the practice and, although they were asked to provide data at the end of their involvement, none of them did so. completers did not differ from drop-outs on any clinical or mechanistic measures (all p > . ). participants generally cited logistical reasons for not completing the group (i.e., surgery, moving, untenable commute, family emergency), although two stated that the group did not meet their expectations. credibility questions were rated on an -point scale, with higher numbers indicating greater credibility. average ratings were as follows: . (sd = . ) for how logical the intervention seems for ptsd, . (sd = . ) for confidence that the intervention will help with functioning, . (sd = . ) for confidence that the approach will help with ptsd, and . (sd = . ) for confidence in referring a friend to the program. the range of scores for those who completed - sessions was . - . whereas the range for those who completed or more sessions was . - . . the average csq- score was . (sd = . , range - , instrument range - ). the average number of minutes participants reported practicing each week (and percent of attendees turning in homework records) were as follows: min ( %) during week (target min), min ( %) during week (target min sessions - ), min ( %) during week , min ( %) during week , min ( %) during week (target min sessions - ), min ( %) during week , min ( %) during week , min during week ( / participants reporting), and min during week ( / participants reporting). based on the qualitative interviews, participants felt that min was too long for the sessions; once group length was reduced to min, participants no longer suggested shortening groups. sessions were reconfigured to allow for additional discussion time because several participants were dissatisfied with the way that time was divided among presentation of new material, discussion, and practiced meditation. many mentioned that it was at least - weeks before people felt comfortable in the group, and they worried that because of the time needed to adjust, they had lost time in adequately learning the initial materials, which were built upon in subsequent later sessions. on the other hand, some felt that it was challenging to give everyone a chance to talk during informal discussions, particularly after the group became comfortable. finally, most participants stated that different learning levels in the class might have been better supported by providing more practice time with new material during the sessions to make some of the homework easier to absorb. this was addressed by having participants summarize past sessions and by using the final two sessions to consolidate learning. figure depicts the change over time in ptsd and depression. the effect sizes, calculated based on change from the first to last session attended, were partial eta squared of . for ptsd and. for depression. these would typically be interpreted as large effect sizes (cohen ) . the change in ptsd symptoms (pcl- total score), f( , . ) = . , p < . , and depression (phq- total score), f( , . ) = . , p = . , reached statistical significance, but audit-c did not, f( , . ) = . , ns. no change was observed in positive emotion (mdes positive), f( , . ) = . , ns, or negative emotion (mdes negative), f( , . ) = . , ns, a presented in fig. . data from the scs-r and scs-sf, which are similarly unchanged, are presented in table . several participants described an increased sense of peace and resilience during the qualitative interviews: for example: bi react a little different to certain things…i'm a lot calmer and i try to think about it first. i try to think about how i'm feeling and why.b my tendency before is that i'd get worked up too easily and act out in anger instead of rationally.b the meditation training had a very high calming ef-fect…i used the breathing to keep me from getting agitated or if i was feeling anxious or stressed in class. lso consistent with the intention of the intervention, participants expressed differences in the way that they think about others and themselves. exemplars of this are as follows: bi feel a little bit more compassion for other people's feelings and mine also. i try not to be so judgmental and give them the benefit of the doubt.b i was the kind of person that i wouldn't look or smile at people but now i try to be more tolerant and be friendlier. i'm trying to open up a little more to people i don't know.b we learned in class that everyone is just trying to be happy and that really clicked for me.Ô thers, however, suggested to us that the group began changes that were not complete. for instance: bi spent a lot of time with unpleasant thoughts. i am able to bcatch and release^a little easier and filter through what i want to be thinking. i still feel i have a long ways to go but i think i can do it.b i'd like to say that i appreciate people more but i don't.b i'm not letting go of things and giving people the benefit of the doubt. i haven't improved in those things but at least i'm aware of it.b i don't think i communicate with people any different yet, but i am learning to refocus in my environment to not react.m this project adapted a standard cm program to meet the needs of veterans with ptsd. the resulting manualized protocol, cbct-vet, appears to have potential in supporting recovery among veterans with ptsd. the now ten-session protocol was implemented in a series of four groups within a general va mental health clinic, involving participants who are generally representative of those who seek care at the facility. this open trial suggests that compassion meditation may help alleviate symptoms of ptsd and depression, although causality cannot be concluded based on this study design and the mechanism by which change occurs is unclear. the intervention was received well by participants based on ratings of credibility and satisfaction as well as qualitative interviews. the program was feasible to implement, although % completion is on the low end of what is typically observed in veterans with ptsd (e.g., polusny et al. ( ) , who had % completion of mindfulness-based stress reduction in their recent randomized trial). our conjecture that cm increases positive emotion, which was based largely on data from non-clinical samples, was not consistent with what we observed in our sessions and are not depicted because the very small sample size in those sessions (n = ) creates a misleading visual weekly emotion measure. qualitative data, however, suggest that participants experienced a greater sense of calm because of the intervention. thus, it is possible that the set of positive emotions measured by the mdes (i.e., joy, gratitude, contentment, interest, hope, pride, amusement, inspiration, awe, love) were relatively less impacted than a sense of peace and calm. in the future, considering emotional arousal and valence dimensionally, as suggested by in the circumplex model of emotions (russell ) , may be helpful in better understanding the emotional impact of cm. kearney et al. ( ) , for example, found some differences in terms of activated and unactivated emotions using the circumplex measure of emotion in their open trial of lkm for ptsd. it is also possible that change in positive emotion did not occur within the timeframe measured within this study but may become evident with continued practice. longerterm follow-up may be important in terms of understanding the nature of emotional change associated with compassion meditation practice. similarly, our measures of social connectedness and self-compassion were apparently unchanged by group participation. although the power is lower for these tests than for measures collected weekly, mean values, fig. change in positive and negative emotions over the period of the group. note: mdes: modified differential emotions scale. sessions and are not depicted because the very small sample size in those sessions (n = ) creates a misleading visual which changed very little, do not suggest that we simply lacked power to detect change. our qualitative data suggest that participants were beginning to change in terms of the way that they think about themselves and others but that such changes would take time. further, social connectedness reflects one's social network; once attitudes about others change, it likely takes time additional time to change one's relationships. it is possible that different measures (e.g., of empathy or social bias) may better reflect this early change than did the measures we used. another possibility would be to offer continuing practice to allow changes to consolidate, which was a request of several of the participants who completed the entire program. the question remains as to what led to the large effect size decreases in ptsd and depression that we observed over the course of the groups. it is always possible that non-specific factors, such as group cohesion (ellis et al. ) or hope (gilman et al. ), led to improvements. although the data should be interpreted with caution due to the small sample size, it appears that much of the change occurred in the first weeks when meditation was being taught but the contemplative work about compassion had yet to be presented. this raises the possibility that the general meditation skills, such as mindfulness, could be leading to the observed improvement. this would be consistent with work by owens et al. ( ) , who linked improvements in acting with awareness to decreased ptsd symptoms. we did not observe a change in the abbreviated mindfulness measure that was used in this project, however, so more thorough assessment may be useful in the future. finally, qualitative data suggest that the group may have improved emotion regulation, as people described being less likely to be triggered and more able to let things go. this possibility, too, is worth investigating as we try to understand the psychological mechanisms at work. in summary, this trial provides strong proof of concept evidence for the use of cm to support recovery among veterans with ptsd. a diverse sample of veterans enrolled in the program and provided productive feedback about the groups. we found large effect size changes in symptomatology, but a randomized trial is needed before drawing conclusions. the nonrandomized design of this study leaves open the possibility that observed changes are due to other factors, such as the passage of time, social support or nonspecific aspects of the intervention. the small sample size and self-selection into the trial are also significant limitations. the observed symptom change is based on self-report measures; in future studies these should be complemented by clinician administered tools, as is the gold standard in ptsd trials. weekly symptom assessment is standard for ptsd treatment; nonetheless, the frequency of use of these tools may influence participant responding. future studies should include alternative measures before and after treatment. finally, the treatment manual was modified over the course of this study, so the results reflect application of the general approach by our therapist rather than application of a manualized approach; this issue should be addressed in future studies. author contributions ajl: designed and executed the study, assisted with the treatment development, and wrote the paper. pc: conducted meditation groups and assisted with treatment development. sh: collected and analyzed qualitative data and assisted with treatment development. th: assessed fidelity to cbct and assisted with treatment development. sg: analyzed quantitative data and contributed to the writing of the paper. rg: acted as the research assistant and assisted with treatment development. me: assisted with treatment development. ln: developed cbct and assisted with treatment development. funding this study was funded by national institute for complementary and integrative health r at - a (pi, lang). ethical approval irb approval for this study was provided by the irb of the va san diego healthcare system. all procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional review board and with the helsinki declaration and its later amendments or comparable ethical standards. informed consent informed consent was obtained from all individual participants included in the study. 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the life events checklist for dsm- (lec- ) the ptsd checklist for dsm- (pcl- ) compassion training alters altruism and neural responses to suffering the effect of loving-kindness meditation on positive emotions: a metaanalytic review key: cord- - v o krh authors: gosliner, wendi; chen, wei-ting; johnson, cathryn; esparza, elsa michelle; price, natalie; hecht, ken; ritchie, lorrene title: participants’ experiences of the – government shutdown and subsequent supplemental nutrition assistance program (snap) benefit disruption can inform future policy date: - - journal: nutrients doi: . /nu sha: doc_id: cord_uid: v o krh the federal government shutdown from december to january created an unprecedented disruption in supplemental nutrition assistance program (snap) benefits. we conducted a cross-sectional qualitative study to begin to capture how the disruption affected food security and wellbeing among a small sample of california snap participants. we collected data from low-income adults in four focus groups in four diverse california counties. we found that participants routinely struggle to secure an adequate and healthy diet in the context of high costs of living, the shutdown and benefit disruption added to participants’ stress and uncertainty and exacerbated food insecurity, and it diminished some participants’ faith in government. participants reported that, while having additional benefits in january felt like a relief from typical end-of-month deprivation, the subsequent extended gap between benefit distributions and a lack of clarity about future benefits caused cascading effects as participants later had to divert money from other expenses to buy food and faced added uncertainty about future economic stability. additionally, the shutdown highlighted challenges related to the availability, timing, and tone of communications between participants and snap agencies. participants recommended that snap adjust benefit and eligibility levels to better address costs of living, improve customer service, and avoid future disruptions. the supplemental nutrition assistance program (snap, formerly known as food stamps), provides critical funds to low-income families to support food purchases, helping to alleviate poverty and food insecurity. in an average month in , more than million americans participated in snap, at a total cost of approximately $ billion dollars annually [ ] . in , snap lifted . million people out of poverty [ ] ; the poverty reducing benefits of snap are so large that, without the program, the child poverty rate in the u.s. would be % instead of % [ ] . more than % of snap participants are families with children, almost % live in households with members who are elderly or have disabilities, and more than % of snap participants are in working families [ ] . while snap reduces operations within days of the cr's expiration [ ] [ ] [ ] . despite the operational challenges of this approach, state and county snap agencies worked to mitigate harm to clients and issue february benefits early (within the -day period of the former cr expiring) to protect february benefit issuance despite the shutdown. although participants ultimately did not miss a month of snap benefits, they did experience an unprecedented disruption in benefit issuance with a longer than normal gap between snap benefit issuance, from a usual maximum of days to up to days. in california, february benefits were issued between january and , and march benefits were issued on march , a gap of - days [ , ] . at the time usda released communications about february snap benefit issuance, they were unable to address what would happen in march if the shutdown continued [ , , ] , leaving participants uncertain about their future food access. the aim of this study was to begin to capture some of the ways in which the snap disruption affected the food security, health, and wellbeing of a small sample of california snap participants. initial questions aimed to capture the baseline (prior to the government shutdown) food security, health, and wellbeing of this convenience sample of snap participants. further questions then explored whether participants' experiences changed as a result of the shutdown and snap benefit disruption. although the monthly cycle of food insecurity among snap participants is well-documented, this study is believed to be the first to capture the short-and potential long-term effects a disruption of snap benefits had on participating low-income households. the nutrition policy institute in partnership with university of california cooperative extension advisors in three california counties received a rapid-response opportunity grant from the university of california, division of agriculture and natural resources, to conduct a cross-sectional qualitative study to capture the experiences of snap (called calfresh in california) participants during the benefit disruption. we collected data in four focus groups, three in english and one in spanish, with low-income adults in four counties in california from february , to march , (table ) during and just after participants experienced a longer than usual gap between snap benefit issuance. counties were selected to include urban (los angeles and san francisco), suburban (san mateo), and rural (tuolumne) areas (table ) . a semi-structured focus group interview guide was developed by the research team and reviewed by three external national snap research and policy experts. the guide asked about participants' usual food routines, the level of support snap provides, how they understood and experienced receiving february's snap benefit in january, whether the disruption in benefits impacted their family's health or stress levels, whether the experience changed the way they think about snap, and what they recommend decision makers could do to better help them (table ) . what did you think about getting a second benefit payment in january? why do you think you got this benefit? can you think of any ways in which getting the february benefits in january changed how you shopped for food or what you ate in january? can you think of any ways that your family's health was different in january because of this change in how you got calfresh/ebt? thinking about stress, how would you say the payment of february calfresh/ebt benefits in january impacted your stress level? have any changes in stress affected how well you feel? what about your family members? did you have any days that you missed work or school due to health issues in january? any hospitalizations? did your children have any changes in their school attendance, behavior, or achievement during january? can you think of any ways in which the longer period between receiving calfresh/ebt benefits has changed how you shopped for or got food or what you ate in february? can you think of any ways that your family's health was different in february? thinking about your stress level, how has increased time between calfresh benefits impacted your stress level? what do you want decision makers to know about your experience with this change in calfresh/ebt payments? has this change in payments led you to think about any ways you'd like to see calfresh/ebt change? has this given you any new ideas about your usual calfresh/ebt benefit levels? how can calfresh/ebt better help you and your family? if your calfresh benefits could be increased, how much more per week do you think it would take for you to be able to feed yourself/your family? participating counties were selected to represent some of california's diversity, including people living in urban and rural areas, speaking primarily english or spanish, and including different age and racial/ethnic groups. county cooperative extension advisors reached out to community partners in their counties that have strong relationships with snap participants and were willing to host focus groups. participating organizations included a homeless shelter, a middle school, and two food banks (one of which secured an alternate location for the focus group meeting). agencies were provided with participant recruitment scripts and eligibility criteria (which focused on snap participation) and were asked to reach out to a convenience sample of clients to invite to attend the groups. whenever possible, agency staff called participants with a reminder the day prior to the focus group meeting. two researchers led focus groups: one conducted three groups in english and the second conducted one group in spanish. three cooperative extension advisors co-facilitated the focus groups conducted in their counties of work. focus group participants completed a demographic survey that included questions about gender, age, race/ethnicity, education, employment, income, marital status, food assistance program participation, and food security. each focus group lasted approximately . hours and was audio recorded. a commercial service was used to transcribe and translate focus group recordings. four researchers, including a lead researcher and the three co-facilitators, reviewed the transcripts. a codebook was developed based upon the main topics in the focus group guide and was agreed upon by the research team. the lead researcher read and coded all four transcripts and created a summary table of coding results. the co-facilitator of each focus group reviewed the transcripts against the coding results to ensure consistency of interpretations. the researchers used memos to capture themes and emergent findings throughout the analysis process. the research team met four times for - h each between march and june , to discuss and reach consensus on the findings. twenty-six adults participated in the study. most participants were female, ages - , white or latinx, and reported experiencing an indicator of food insecurity (table ) . findings emerged across five themes: ( ) the usual struggles participants face in securing an adequate diet; ( ) general challenges participants experience utilizing the snap program; ( ) specific challenges participants experienced with snap during the benefit disruption; ( ) the negative impact the disruption had on participants' food security, stress levels, finances, and perceptions of government support; and ( ) participants' recommendations for snap moving forward. the challenges participants routinely confront in trying to feed themselves and their families were discussed multiple times in all focus groups. participants described using numerous coping skills to ensure they do not go hungry, such as shopping at multiple retailers, coupon clipping, freezing food, and using food pantries. despite their best efforts, most reported routinely running out of money to buy food during the month, and some reported cutting the size of their own and their children's food portions. participants reported that the high costs of living, inadequate or low-wage employment, and/or their limited fixed income from other public programs (social security, disability, and unemployment) meant that they routinely faced food insecurity. as one participant said: you know, with our incomes, and especially with the rent is so high and our bills . . . it gets really stressful trying to be like, 'okay, where's my next meal gonna come from? how am i going to feed my kids' another participant described how food insecurity presented challenges due to her struggles with a health condition: i have to eat healthy with my-my gi problems that i have. i have to eat white plain chicken, you know, fresh vegetables, and they don't bother me so much . . . but . . . you run out of the chicken, or whatever, you run out of vegetables. then you've got a can of raviolis that the food bank gave you. well, that's what you eat. and it tears you up. you know it makes you sick, but you gotta eat. participants in all focus groups repeatedly talked about how expensive food is. they described searching to find lower prices on food items, buying junk foods and other "cheap" foods to get more for their money, and struggling to buy healthy foods, which they reported to be too expensive. as one said: sodas and all that, it's easy to last longer, but it's like trying to do that, they last through the end of the month, and healthy food is hard . . . you're trying to make your kids eat healthy, but it's really expensive at the same time . . . . participants in each focus group expressed gratitude for the snap program; however, the sentiment expressed most frequently was that snap benefit levels are inadequate to meet participants' food needs. additionally, many participants described negative experiences with snap, such as challenges with eligibility requirements or benefit formulas, and difficult communications with caseworkers. the most frequent issue raised about snap was that benefit levels are too low to provide food security and support an adequate, healthy diet. as one said: . . . what they give us is not enough for one month, that they should try to help us a little more . . . . they should think about the children because more than anything else, the food you ask for is for them, they should think about what hurts our children. many participants felt that snap eligibility and benefit calculations did not adequately account for their high costs of living. while this topic arose in all focus groups, it was more prevalent in the three groups conducted in los angeles, san francisco, and san mateo counties. in these areas, the cost of housing was routinely discussed as a major challenge. even in the group conducted in a homeless shelter, a participant talked about trying-and failing-to secure snap benefits when she and her husband both worked full-time at low wages, despite their inability to afford rent and other expenses which caused them to lose their housing: it's really hard out here . . . i'm pretty sure all of us pay our taxes, you know, we pay our dues. we do it, everything that we needed to be doing, but yet still we get slapped in the face like, 'no, you can't qualify for that because of this and that.' and that makes it even more stressful, you know? in the rural county, where housing costs are lower but transportation options are limited and communities are geographically dispersed, participants raised the cost of gas as a major barrier to food security. as one rural participant said: you have to go back and forth and be able to get to different stores and then maybe be able to go back to a different store in order to get the best prices and everything, but then of course, [gasps] 'that costs gas.' participants raised a number of challenges related to snap administration-both with program rules and with customer service and communications. many described these experiences as leaving them feeling undignified, disrespected, or not cared about. for example, some participants referred to the minimum $ snap benefit this way: participant : i think giving $ a month to anyone is ludicrous. it's like an insult. a number of participants reported challenging experiences related to snap customer service when dealing with issues of eligibility, enrollment, and participation. one participant said: there are times when you are disappointed when you go to ask for help, because some workers make you feel that the help you are going to ask for is coming out of their paycheck. but the communications for this welfare office . . . i have called them and called them and called them and you know, they won't return any phone calls . . . they don't want to talk to me. i don't know why, but maybe it's just the way they treat everybody. finally, a number of participants described confusion and lag time related to frequent changes in their household circumstances that impact their benefits. these changes included adding family members, children leaving the household, changes in employment or eligibility for other public programs, and missing a snap administrative deadline, for example a recertification of income eligibility. lag time refers to delays in budget adjustments when participants with hourly jobs, for example, follow stringent rules about reporting income fluctuations and experience a delayed response in adjusting their benefit that does not align with their needs. participants generally reported that these situations were confusing, that they struggled to reach caseworkers to get their questions answered, and that the result was uncertainty about the level of benefit they would be receiving in any given month. one participant said: . . . i applied for unemployment, but i was never granted, but i applied. somewhere in the system . . . it told them that i-i was receiving benefits from unemployment, which i wasn't . . . but calfresh cut it, like majorly, like % . . . participants in two of the four groups discussed challenges related to benefit levels declining when their earned income increases. one said: . . . when you go to work and make your check and then they cut your food stamp down and now, you've got to spend your cash now. it's supposed to be for the bills and you ain't got cash for the bills and it's just a vicious circle. another participant said that the lag time in response to situational changes meant that needs and benefit levels were not always aligned: when it goes down, they decrease it in so many days, or weeks, or months after you make the amount. so then you go down again in the amount that you're making and so then it isn't working out. you don't have crap when you need it and you have more when you don't. these changes in benefit levels due to program administrative policies create further volatility and uncertainty in snap recipients' finances and compromise their food security. in california, snap benefits are distributed by county social services agencies, and each jurisdiction makes its own decision regarding how and what they communicate with snap participants. as such, participants in the four focus group counties reported slightly different experiences with official communications related to the benefit disruption. in every group, participants reported receiving the additional benefits prior to receiving formal communication from the snap administrative agency. in two of the counties, participants said they never received communication from their county agency or caseworker regarding the benefit disruption, but some participants called the agency to find out why they had the extra money. in one of these counties, one participant said that she used a mobile app, available through the county social services agency, and that the app provided information about the disruption. however, another participant in that county had not gotten the information, saying: like, i would have rather have them communicate clearly about what they were doing that month, because i never got the message . . . so i didn't know. in the other two counties, at least some participants reported getting a phone call from the county social services agency. these calls reportedly came at least a day or two after the benefits were distributed, and in some cases participants had spent the benefits before receiving the official notification. in some groups, participants reported learning about the disruption from news stories or from social media or word-of-mouth. one said: i was hearing stuff about government and stuff like that and everything. so i guess that's why it was getting messed with, federal stuff. across all groups, confusion about the benefit disruption was discussed repeatedly. in some cases, the disruption occurred while participants were seeking benefit adjustments for other reasons. as one participant said: . . . i turned in my thing and told them, 'hey, i only got this. i think i should get an increase from my $ .' and . . . so i didn't know about any of this other stuff going on and them doing their added thing for the government. and so i was confused. i was like, 'okay is that my-is that how much they increased it? they just gave me an extra $ . [laughs] what's going on?' and then i called . . . and they explained it, but yeah, that was very confusing to me . . . although it was the exception rather than the rule, in every county, at least one participant reported spending the february benefit before understanding why they had received the additional funds. various reasons were provided to explain this. for example, in two of the groups, at least one participant reported worrying that the extra benefits received in january would disappear if they were not spent before the end of that month. as one group discussed: participant : i have also heard that about the food stamps um, um, if you don't use 'em, you lose 'em . . . . so you be afraid to-and you can't get anybody to answer the question. she's right. they just send you letters threatening you that, but they never do, do it. another participant described the impetus for spending the unexpected benefit quickly this way: i was worried that i needed to spend it because with the wacky, screwy way everything is going, i didn't know if they would take it away with the government shut down, so i had to spend the whole thing. but i got stuff that i could freeze . . . in three of the groups, participants reported thinking that the additional benefits received in january were an administrative mistake. participants expressed various, and sometimes mixed emotional responses to this "mistake." one said, "we thought we had won the lottery." another said: i was scared. i said, 'the government made a mistake . . . i got scared, but i was happy, i thought they were wrong, it scared me but made me happy at the same time. in every focus group, at least one participant thought that the national snap program was ending, and that the extra benefits they received were being provided as a final "bonus" to participants. in one county, this feeling was linked to a message the local social services agency circulated to participants, expressing uncertainty about the march benefit distribution. in other cases, the idea that the program was ending came from word-of-mouth or other sources. as one participant said: the news i heard said maybe there were going to be changes, that they were not going to give benefits anymore, and that was why they paid the month in advance . . . i thought that there was not going to be any help anymore . . . the help is over. another said: i thought that maybe they were going to take it away, because i heard rumors that they were about to take the aid away. so, i said, 'maybe they gave us the last month because they want to say that there is not going to be more money.' . . . i imagined it this way, but many people were saying that they were going to remove the stamps and that they were not giving them anymore. in each group, at least one participant talked about splurging in january or treating themselves or their children to something a little bit extra or special. in three of the four groups, this topic was raised multiple times. in some cases, the extra spending was due to confusion or incorrect information about the reason for the additional money in their account. as one said: we splurged in january, so, um, and not realizing that we were not gonna get benefits in . . . february . . . you know, in february, um, we just ate less. some participants talked about sharing what they thought were extra benefits with family and/or friends. one said: i'm going to eat, i'm going to eat well, healthy and well. first, i bought meat, to make roast meat for my children that day, and i invited my siblings who live opposite my house. i told them, 'let's eat roast meat. help me.' so then when they doubled it, i was like, like i said, we took a bunch of friends to take them to safeway to get them food and we ate good. um, we ate things that we couldn't eat, like a steak. in other cases, participants knew that the extra funds were for february's benefits, but they still changed their behavior in january. one said: i did hear in the news, but i'm like, 'let me go get what we need.' but when you go to the market, you grab more to eat, especially when the kids are there, and you have young kids . . . . and i know it's bad, but sometimes as mothers, you don't know how to say 'no.' . . . especially you grew up with parents that struggled too . . . so, for my kids, i try to give them what i didn't have . . . it was a struggle, that month. across all groups, the overwhelming sentiment was that the disruption in snap benefits had a negative impact. some people referred to this in a general way, saying things like, "i think we pretty much all agree it kind of screwed us" or "it messed people up." one said, "it was a . . . going from having extra to having too little." only a couple of participants, at least one of whom received the minimum $ monthly distribution, reported that the disruption had little or no impact. the most discussed impact was stress, which was raised repeatedly in three of the four groups. for many participants, the stress was related to uncertainty-uncertainty about how to make their benefits last for longer than usual, uncertainty about whether the program was ending, and uncertainty about why they received the additional funds on their cards. as one said: i was stressed because i didn't know what's going on. another said: when we were already in a state of chaos and concern and worry, do not make it worse by doing things that we don't know about, don't understand, don't get information on. although parents of younger children did not indicate that their children were aware of the disruption, one parent of a teen said: in my case, my daughter, the oldest, already notices more or sees things. she said, 'mom, did they advance you the money because they're going to take away your help?' because medical help is also included, she said, 'mommy, are you not going to be able to take me to the doctor, to the dentist anymore?' . . . she was worried. in every group, at least one participant talked about receiving february's benefit in january as an initial relief. receiving the benefit during a time of the month when participants' food budget generally has been exhausted meant some people experienced temporary relief from the usual cycle of scarcity. one participant described the relief this way: you don't even think about it, it's just a big stress relief . . . that's a big burden off your back kinda type of thing, how you gonna survive this month literally by eating is, yeah, that's-that's something you don't have to worry about at that point . . . i was happy because i had a lot of money [laughs] for food. a few participants talked about being able to eat healthier in january. one said: i ate a lot better in january, because i had more. i've been able to go more to get more fresh vegetables . . . . however, the relief quickly turned to stress. one participant described it this way: it's nice to have more benefits, but if you think about it, you're going to spend them, and you still have the whole month of february, and say, 'okay, i spent them. but what about february? what am i going to do? what's going to happen then?' another described the combined relief and concern this way: i was able to get a little bit more with that double benefit. um, i wasn't limited to and trying to make it stretch for that month. i was able to, like, buy stuff to make a complete meal, you know what i mean? and so it was good. you know, it was good and bad . . . across all groups, participants talked about negative food security impacts of the benefit disruption, and some talked about negative financial and health impacts as well. one mother talked about utilizing a new charitable food program in february, after she had run out of money to buy food for her family. she said: the food boxes definitely came in handy, um, um, very appreciative for those. um, different pantries that give out the eggs, rice and things like that because that's what they [the kids] love. well, my daughter [also a snap participant] . . . feeds five people and, um, she said it was really hard for her, because she got all that money in january and . . . she bought a lot of extra stuff, and she just didn't have anything much for february . . . . she stocked up the best she could, but feeding five people and a teenager was very difficult. further, the disruption highlighted the economic uncertainty that snap recipients live with. one participant described the impact this way: i felt the impact and it just took me back to feeling poor. participants described challenges related to financial impacts of the disruption, because most reported spending their snap benefits earlier in the month and running out of money to buy food in february in a way that was different from usual. one said: that's what changed this month. in these last two weeks, i had to take from the money we were saving to pay the rent, which had never happened. for many participants, the disruption to their snap benefits led them to have to adjust their finances in ways that meant they continued to have to deal with the after-effects even after the shutdown itself had passed: she [speaker's daughter] had to use her gas money for food, because she's still kind of playing catch up . . . . she called me several times crying, 'ma, i don't-we don't have enough food. what am i going to do . . . ? you know, i can't afford to this and this and this.' and i can't help her. so there was a lot of times that all she had was like crackers and whatever. so it was very difficult for them. and i can imagine people with families have the same problem. it's a huge domino effect, really. it really, really is, 'cause when you-you're just trying to catch up from . . . february, and here's march and you just have to get extra stuff that you couldn't buy in february, you know, and it's this big old domino effect. a couple of participants talked about going into debt in february in order to have money to buy food. one said: right now, the only difficult decision we have is the stress of paying off what we are borrowing with interest . . . having to use it to pay off the rent. you have to do one thing and fail at another. you get into debt with the cards and then it's a mess. participants reported that the benefit disruption impacted their perceptions of the government and overall feelings of security related to government programs. as one said: you cannot always depend on it [snap] . 'cause, like he said, we didn't expect nothing like this happened. so you can kind of, like, never know. another said: i mean, i'm grateful for the government, you know, for it to help me with the food stamps or whatever. but at the same time, i feel like it's just like they can-all of a sudden within a blink of an eye, they can take it all away. and then what are we going to do? in another group, a pair discussed the new uncertainty: participant : and it's still stressful, because i'm thinking in my head, you know, like, 'okay, this is three months solid now that you've been playing around with the money for these people. what is it going to be? what is-is april going to be nothing?' participant : yeah, that was my major concern. and that-that is very stressful. one participant characterized the increased insecurity of public assistance and the stress it caused this way: additionally, in three of the four focus groups, the sentiment that the benefit disruption shook participants' overall faith in government was raised multiple times. this topic was not discussed in the focus group conducted in spanish in la. it was discussed more frequently and with more emotion in the focus group conducted in rural tuolumne county. one participant said: it's obviously caused a lot of . . . confusion to people and-and the mass hysteria is pointing to, you know, that our government in america can't get your blank [sic] together, to where we're all being in confusion and craziness like this. it's not healthy for us, period. and they just kind of like-like it's nothing on us, like a game or something to them. this isn't a game. this is reality. in another exchange, participants said: participant : participant : it's just disgusting to think that the gover-you know, the government or the powers that be like to have their reason to want that to happen to their people. i mean, i don't understand what the point of doing that to people is. to see if they can take it or not or what, what's the deal here? participant : participant : they don't care, they're getting their paycheck. they don't need food stamps. they get paid whether they work or not . . . participants expressed a number of ways in which they felt the snap program could be improved to better meet their needs and support their families. the recommendations focused on four main issues: improve benefit adequacy by increasing benefit levels. modify eligibility and benefit formulas to better address high costs-of-living as well as the expenses associated with working (e.g., transportation, child care). improve customer service and communications. do not disrupt snap benefits in the future. the most salient recommendation was to increase the snap benefit level. there was strong agreement across participants in all groups that they would benefit from increased snap benefits. when asked what additional benefit amount would meet their needs, responses varied. generally, participants receiving lower benefit levels suggested at least doubling their monthly allotment, such that some participants said an extra $ /month would really help. participants receiving higher benefit levels suggested larger increases, generally ranging $ - /month. in two of the groups, the recommendation that snap benefits be allowed to be spent on hot foods and/or household items, such as cleaning products and toiletries, was raised multiple times. sometimes participants suggested providing this in the context of increasing their unrestricted cash benefits. one participant said: i would, um, actually ask for more cash too, like she was saying. um, if we could, um, be able to use that ebt [snap] money for toiletries, that would, you know, it would just help me a lot. participants recommended that snap could improve both eligibility determinations and benefit calculations by altering the formulas to better account for costs of living and working. in the three groups conducted in urban or suburban settings, changing the eligibility and benefit formulas to better account for high rents was a priority. in the rural setting, participants recommended more effectively considering transportation costs, as they reported high gas expenses for getting to work, school, grocery stores, and charitable food sites. further, participants working in jobs with fluctuating hours recommended that the program develop more responsive mechanisms for adjusting to these changes. participants experiencing changes in family composition, access to public welfare programs, and other changes also recommended that the program become more agile in order to provide the needed support during the timeframe it would be most beneficial. in the rural focus group, participants agreed that they would prefer snap benefits to always be distributed to all participants on the first of the month, as they were in march . participants said that because they receive cash on the first of the month-either through paid employment, disability, or social security-it is challenging not to receive snap benefits at that time. as one said: . . . when i get my [non-snap] money, i go to walmart and buy the stuff i need that i have to pay for and i like to buy some of the food there, but then i have to go back out when i get it [snap benefits] on the sixth and go to grocery outlet and then back to walmart to buy the less expensive stuff. so it's-it's a matter of convenience, but also the cost of gas, time, energy . . . participants in some of the focus groups specifically talked about improving snap customer service, especially improving communications with participants. in one group, participants recommended improved communications if a government shutdown or other disruption were to happen again, saying: i would like to see more literature if that happens again, so that people don't go overspending and they have enough. participants in another group recommended that a wider variety of communication channels be utilized in the event of a future disruption, such as us mail, phone, email, and social media. participants' stories highlighted their experiences of routine deprivation and struggle, experiences that for some were initially relieved by the disruption when they received february benefits in january, but for nearly all were ultimately exacerbated by it. the most salient themes to emerge were related to routine food insecurity, challenges of affording an adequate and healthy diet, and the inadequacy of snap benefits to meet participants' food needs, all of which were intensified by the shutdown. despite sharing multiple stories of acting with human agency to cope with difficult life circumstances, as has been reported in earlier studies [ , ] , many participants described experiences of feeling vulnerable and barely making ends meet. participants repeatedly expressed that the snap benefits they receive are not enough to provide food security or to enable them to eat an adequate healthy diet throughout the month. participants described eating cheap foods, foods they do not necessarily like but can afford, and not eating meats, vegetables, and other foods because they are too expensive. prior qualitative studies also have reported that snap participants routinely are unable to meet their food needs with the resources available to them, and that participants perceive healthy foods to be unaffordable [ , ] . in some cases, participants described feeling relief prior to realizing the additional benefit money was an early payment of february's benefit, amplifying the vulnerabilities inherent in snap and creating incremental stress on an already stressed population. interestingly, some participants said that, even though they knew the additional benefits were for february, having extra money for food at the end of the month in january-when they are accustomed to being unable to buy enough food-provided temporary relief despite knowing it would cause future hardship. some participants said they were able to eat healthier; parents reported feeling that they could treat their children to favorite foods; others invited friends to share a meal. these stories highlight the basic social feeding experiences that snap participants are denied on a regular basis. having what felt like extra money in january enabled participants to do what many americans likely take for granted: treating themselves or their children, sharing food with others, or eating the healthy foods that allow them to feel well. the challenge the government shutdown presented to social services agencies was not within the scope of this study, but must be acknowledged. that participants received snap benefits for february at all can, in many ways, be seen as a tremendous success and social services agencies deserve much credit for scrambling to ensure snap funds were distributed. however, it is critical for decision makers, service providers, and the public to understand that the federal government shutdown and subsequent snap benefit disruption felt devastating to many snap participants. in california, while some social services agencies communicated with participants via mobile apps, email, or phone messages, many of the study participants did not receive any communication about the benefit disruption from their agency. even among those who did report receiving agency communications, many said they came after the benefits were received. while we did not probe in depth about how participants would like to receive communications in the future, we did hear that participants have different levels of access to communications technologies. while some relied on landline telephones or network tv news, others were using cellphones, apps, or reading newspapers. while more work is needed to understand local contexts and optimal communications, our work suggests that using multiple channels of communications is likely to be critical due to the variety in access illustrated in our focus groups. most participants talked about this period being very confusing. participants described knowing it would be difficult not to spend the benefits too early and feeling worried about how they could "stretch" their money to make it last. many participants reported feeling like they are at the mercy of the government support, for some because they are disabled, for others because they are retired or lack access to more stable or higher paying work opportunities. these participants expressed fear and anxiety about having safety net support when they need it in the future. the confusion, stress, and ongoing uncertainty that resulted from the shutdown were discussed in all focus groups, and in some with a lot of emotion. many participants also expressed increased or newfound distrust of the government and lack of confidence in the safety net as a result of the government shutdown and snap benefit disruption, and felt that they were pawns in a political game that did not fully consider the consequences to them and their children. many participants described financial circumstances that change regularly and felt that snap benefits are not able to keep pace with the changes. studies have found that income volatility is widespread, with more than a third of american households facing annual income spikes and dips [ ] . considering fluctuations in income when creating administrative policies related to budget adjustments for snap would help to meet participants' needs. a recurring theme in all four focus groups was the desire for the safety net system to treat snap recipients with more respect and protect their sense of dignity. although there is research suggesting that the relationship between temporary assistance for needy families (tanf) caseworkers and their clients may influence client outcomes, little is known about effects of relationship quality between snap caseworkers and their clients [ , ] . our results emphasize the importance of participants being treated with respect by frontline social services staff and caseworkers when they apply for benefits. another way participants suggested demonstrating respect is by improving communications to recipients and explaining program changes or administrative procedures in a more timely manner. these findings add to what we know about participant frustrations with snap benefits being interrupted, reduced, or cancelled without prior notification [ ] . participants also suggested that respect can be demonstrated by increasing benefit levels. providing a reliable safety net for families who fall on hard times is another way of showing respect and many studies show that snap benefits fall short of what households need to ensure a nutritionally adequate diet [ ] [ ] [ ] [ ] [ ] . while snap is intended to supplement a family's food budget, snap is the only mechanism by which many families are able to receive minimum levels of nutrition and reduce food insecurity [ ] . while most of the findings reported were similar across the four focus groups, a couple of differences were notable. for example, the group in rural northern california reported routine use of charitable organizations and positive experiences with them, while they reported more negative feelings about the government. in contrast, the latina mothers in los angeles did not report accessing the charitable food system, and expressed less mistrust in the government. these differences align with recent studies suggesting that political trust is generally higher among latinx groups [ , ] . similarly, challenges related to high costs of housing were raised routinely in the los angeles, san francisco, and san mateo focus groups, but housing costs were not discussed in the rural tuolumne county group. there, high costs related to vehicle access and buying gas were discussed frequently, yet these costs were not raised in other groups. it is clear that housing costs differ across geographic location and research supports the importance of adjustments on poverty thresholds for geographic variations in housing costs [ , [ ] [ ] [ ] [ ] . while participants report engaging in a variety of coping behaviors to fend off food scarcity, many strategies require tradeoffs that often compromise health and may have long-term negative financial repercussions [ ] . prior research has demonstrated that snap participants do not completely understand the way in which the snap program calculates benefits [ , ] . the benefit disruption and the way in which participants talked about how they budget and spend their benefits also suggests that participants do not understand the household food budget assumptions behind the snap program structure. while participants clearly express-and research supports-the need to increase snap benefits [ , ] , participants deserve to be given information about the program structure. the snap-education program offers food resource management education to a small fraction of snap-eligible people each year [ ] . better access to financial literacy education could help some participants better understand how snap benefits are calculated, and how they can utilize benefits optimally. although financial literacy would not be expected to fix the challenge of benefit inadequacy in the absence of increases, given the known inadequacy of available support, it may help some participants minimize the harms and this knowledge could help to empower participants to advocate for change. this study has several limitations. it was conducted in response to an unexpected disruption in snap benefits caused by a sudden and prolonged government shutdown. as such, the research was conducted quickly in order to capture participants' experiences during the shutdown disruption. we used a convenience sample of counties and participants in california. while we represented different parts of the state and included different population groups, we missed many others. many of the findings were consistent across groups, but some experiences or concerns that were raised in only one group would have benefitted from testing among additional participants. in no way did this study capture the experiences of all california snap participants; more focus groups with diverse participants would be needed to reach saturation. all researchers reviewed at least two transcripts, but not every researcher on the team reviewed all four transcripts. we met regularly to discuss findings, but because all members of the research team work in public health nutrition, it is possible that our shared training and biases have influenced the results. study results reveal the challenges snap participants faced during the government shutdown, even when benefits were issued early in an attempt to mitigate harm, and shed light on routine struggles of snap participants with food insecurity. participants recommended: ( ) improving benefit adequacy by increasing benefit levels; ( ) modifying eligibility and benefit formulas to better address high costs-of-living as well as the expenses associated with working; ( ) improving customer service and communications; and ( ) not disrupting snap benefits in the future. a reliable social safety net system provides citizens with support they can depend upon when they fall on hard times [ ] . given that more than million americans rely on public assistance to meet their basic need for food, with participation currently spiking due to the covid- pandemic that began in early , it is an important time to increase benefit levels, as has been suggested in multiple studies. under the current administration, various regulatory changes have chipped away at the federal antipoverty program support that families rely on [ ] . the recent federal adoption of measures to reduce snap enrollments-such as the public charge rule and the time limit on snap participation of able-bodied adults without dependents-suggest that political concerns about cost and dependency currently outweigh concerns about the nutritional health of the poor [ ] [ ] [ ] [ ] . covid- has stalled implementation of some of those policies and highlighted the importance of safety net programs, particularly the urgency to feed people during a health crisis. while federal nutrition programs have contingencies built into them to support response and recovery efforts, the pandemic has worsened conditions for families who have the most difficulty affording adequate food [ ] [ ] [ ] . provisions included in the families first coronavirus response act are providing additional snap benefits, but, by authorizing usda to provide the maximum benefit allotment to all households, the provision will not help the nearly % of snap households that are already receiving the maximum snap benefit [ , ] . further, policies must be established to protect funding for social safety net programs such as snap if future shutdowns occur. the security and health of the nation's most vulnerable people is too much to risk for political expediency. we are not aware of any other research that captured the experiences of the millions of snap participants who were impacted by the government shutdown and subsequent benefit disruption. their voices and experiences deserve to be heard and known by all stakeholders involved in making snap policy decisions as well as those serving snap participants. this study suggests that the federal government shutdown and subsequent disruption in snap benefit distribution created short-and longer-term negative impacts to snap participants, including exacerbating food insecurity, burdening participants with additional stress and confusion, causing financial challenges, and eroding some participants' faith in government. the disruption highlighted both the importance and the limitations of snap in reducing food insecurity among people facing economic disadvantage. new strategies for supporting individuals and families struggling to make ends meet are needed. snap can be an important part of the solution, but revisiting eligibility criteria, benefit levels, and customer service practices, as well as establishing policies to protect program participants from future shocks are needed. conducting research to test solutions can help ensure fair, equitable, and effective policies are adopted. a closer look at who benefits from snap: state-by-state fact sheets how much does the supplemental nutrition assistance program reduce food insecurity? measuring the effect of supplemental nutrition assistance program (snap) participation on food security; nutrition assistance program report; mathematica policy research household food security in the united states participant voices: examining issue, program and policy priorities of snap-ed eligible adults in california hunger & health: the role of the supplemental nutrition assistance program in improving health and well-being committee on examination of the adequacy of food resources and snap allotments; food and nutrition board; committee on national statistics; institute of medicine how far do snap benefits fall short of covering the cost of a meal? more adequate snap benefits would help millions of participants better afford food modernizing snap benefits; the hamilton project effects of the decline in the real value of snap benefits from do high food prices increase food insecurity in the united states? map the meal gap : highlights of findings for overall and child food insecurity the thrifty food plan is not thrifty when labor cost is considered not enough money or not enough time to satisfy the thrifty food plan? a cost difference approach for estimating a money-time threshold supplemental nutrition assistance program: initiatives to make snap benefits more adequate significantly improve food security, nutrition, and health recommendations from snap participants to improve wages and end stigma multiple barriers to economic opportunity for the "truly" disadvantaged and vulnerable. russell sage found it's about time: how work schedule instability matters for workers, families, and racial inequality income volatility complicates food assistance links of the supplemental nutrition assistance program with food insecurity, poverty, and health: evidence and potential income volatility and food assistance programs exhaustion of food budgets at month's end and hospital admissions for hypoglycemia. health aff food instability and academic achievement: a quasi-experiment using snap benefit timing design issues in usda's supplemental nutrition assistance program: looking ahead by looking back importance of the supplemental nutrition assistance program in rural america revisiting the supplemental nutrition assistance program cycle of food intake: investigating heterogeneity, diet quality, and a large boost in benefit amounts federal government shutdown enters second week with no resolution in sight as government shutdown persists, americans feel the bite food stamps for millions of americans become pawn in shutdown fight announces plan to protect snap participants' access to snap in february, release no. but millions face cuts if shutdown continues continuing snap in a government shutdown federal shutdown and calfresh: plan for early issuance of february benefits by january plan for single day issuance on pain from the government shutdown spreads. this time it's food stamps. kaiser health news because of shutdown, february food stamps disbursed on wednesday. the philadelphia inquirer captive audience? strategies for acquiring food in two detroit neighborhoods income volatility: new research results with implications for income tax filing and liabilities perceived welfare caseworker support and psychological distress among low-income urban women with children in the oxford handbook of social and political trust trends by geography, tenure, and household income measuring poverty: a new approach geographic variation in the cost of living: implications for the poverty guidelines and program eligibility geographic variations in cost of living: associations with family and child well-being food and financial coping strategies during the monthly supplemental nutrition assistance program cycle analysis of supplemental nutrition assistance program education (snap-ed) data for all states study before the human resources subcommittee of the house committee on ways and means behind trump's plan to target the federal safety net the supplemental nutrition assistance program (snap): history, politics, and public health implications new snap rule would cost many of nation's poorest their food aid president's budget would cut food assistance for millions and radically restructure snap administration should reverse anti-immigrant policies that will worsen impacts of health and economic crises snap covid- emergency allotments guidance emergency allotments phase guidance . us department of agriculture this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license acknowledgments: this study was funded by an opportunity grant from the university of california, division of agriculture and natural resources. elsa esparza was supported by a university of california global food initiative fellowship. the authors declare no conflicts of interest. key: cord- -b f lu authors: ponsero, alise; bartelme, ryan; de oliveira almeida, gustavo; bigelow, alex; tuteja, reetu; ellingson, holly; swetnam, tyson; merchant, nirav; oxnam, maliaca; lyons, eric title: ten simple rules for organizing a data science workshop date: - - journal: plos comput biol doi: . /journal.pcbi. sha: doc_id: cord_uid: b f lu nan computational literacy is now a critical skill in most areas of research and commerce [ ] . there is a demonstrated need for data science training to bridge domain gaps between physical, biological, and computer sciences [ ] . these training sessions can cover a large number of topics such as the use of computational tools in data storage interoperations or the reproducible analysis of large and complex data sets. short (less than a week long), hands-on workshops offer critical skills development for scientists, at all career stages, outside their work schedules. however, training workshops can be particularly challenging to develop and plan. often, such events require coordinating a large team of organizers and instructors [ ] . facilitating a data science workshop poses unique challenges due to the field's large methodological scope. in particular, these trainings need to accommodate participants' heterogeneous scientific and computational backgrounds, while encompassing the diversity of computational resources and best practices. our baseline framework stems from the philosophy and structure used by the carpentries to teach data and software core skills through hands-on workshops [ ] . their pedagogy utilizes short workshops focused on a specific domain within the contextual framework of the topic being taught (e.g., the complete life cycle of data). the carpentries curricula for workshops are iterative, and inclusive to people from any background, with no prior experience in the topic area. their lesson plans are often an excellent place to start finding material when developing a new workshop, though there are many sets of open source materials. here, we discuss the challenges of organizing participatory data science training and provide simple rules to facilitate inclusive workshops. each of these rules can be considered independently, but they are written as a progression of ideas that refer back to previously discussed points. rules - focus on training material development. rule is on testing the developed workshop material. rules and discuss important considerations when running the workshop. finally, rule focuses on the importance of continuously evaluating and learning from past workshops to inform future pedagogy. while short-format workshops are increasingly popular, it should be noted that study showed little difference in long-term performance of graduate students [ ] . however, this study notes that longer formats have shown significant positive outcomes, and the carpentries wrote a thoughtful response [ ] . in addition, the authors reference research describing thresholds of learning for graduate students that must be crossed prior to learning specific data analytical skills [ ] . while further research into this area is warranted, organizers of data science workshops may consider offering the same material with more spacing between lessons. an entire workshop can be challenging to be organized and taught by a single person. the breadth of knowledge required and cognitive biases of a single person could derail a workshop entirely. therefore, the organization and planning of such workshops necessitate collaboration, as the perspective of different people typically allows to develop a more inclusive training material. choosing the right people with whom to collaborate is critical, and using campus or organizational networks to connect instructors assures common interests are met. this also facilitates the creation and maintenance of a set of common goals and shared vision across all team members. we believe that the team should develop and document critical areas of the workshop: ( ) the vision of the workshop; ( ) the goals of the workshop; ( ) the expectations from the instructors; and ( ) who the target participants are. as outlined in table , we refer to the "goal" of a workshop as the broad concepts that participants should expect to learn from the training. in contrast, the "vision" of the workshop should address why these goals are important; the vision details how the skills acquired will help the participants and meet the values of the training program. documenting the critical areas will reduce miscommunication between team members, which is critical for workshops lasting more than a few days, or those that are part of a continuous series. it is critical to acknowledge the time and effort required to prepare, test, and teach the workshop. these events are a great opportunity for students and researchers to develop their teaching and communication skills. importantly, newcomers to instruction should be welcomed and mentored. new instructors may want to review the instructor training material developed by the carpentries [ ] to get familiar with inclusive teaching methods. we recommend that experienced instructors focus on setting the overall tone for the workshop, while providing opportunities for less experienced people to assist in teaching materials. the overall purpose of the workshop. for example, the vision of a git workshop might be to increase participants' abilities to perform reproducible research. the broad concepts that participants should learn that support the vision. for example, a git workshop that introduces participants to version control concepts can increase participants' ability to understand and track how their data and code have changed over the lifespan of a project-ultimately resulting in more reproducible research. learning objectives the specific skills or operations that participants learn and practice that, collectively, accomplish a goal. for example, in a git workshop, learning objectives might include creating branches, staging changes, merging branches, handling merge conflicts, and pushing to or pulling from remote repositories. together, these learning objectives accomplish the goal of introducing participants to version control concepts. blameless retrospectives originate from agile-based software development. their goal is to create a group culture of psychological safety and accountability and facilitate continuous learning. in these retrospectives, it is often useful to refer back to the project management plan and determine which strategies facilitated learning objectives, goals, and contributed to the workshop's vision. in order to alleviate the workload associated with developing the workshop's training material, we recommend a modular approach for developing the teaching material. in this framework, each training module is created and taught by independent teams. the team should refer back to the common guideline developed for the overall workshop (rule ) while defining each module's scope and goals. we believe that smaller teams and modularity of lessons facilitate efficient project management practices. it is important for the instructors to establish a schedule for the development of training modules as well as provide time for testing new materials. organizational management tools like zenhub (https://www.zenhub.com), trello (https://trello.com), or basecamp (https://basecamp.com/) can help the coordinator track progress while the workshop is in development. as workshop development matures, these tools can also provide a place to develop backup plans for alternative locations, equipment, instructors, etc. this is also important when teaching online workshops, which can face their own specific technical hardships. ultimately, good project management tools ensure overall workshop leadership can track all teams' curricula developments, while also creating a unified communication framework and an explicit schedule of the workshop events. we recognize a potential pitfall of developing modular training material (rule ) could be differences in presentation style, supporting documentation, and learning objectives. connecting learning objectives from different training modules taught by different instructors requires a large effort in coordination and communication. therefore, a person should be designated as the overall coordinator to ensure learning objectives from individual training modules are connected. for smaller workshops, this coordinator may also work in an instructor team. the coordinator's work can be facilitated through project management tools outlined in rule , and ideally, the coordinator would act as the project manager. finally, the workshop coordinator should ensure each session and learning objectives build toward the overall vision and goals of the workshop (rule ). the workshop coordinator ensures the connection of the different modules developed by the team (rule ). however, these connections should also be evident to the learner-it can be easy for both instructors and participants to lose sight of learning objectives, leading to many other pitfalls. an overview of skills in each session helps ground participants' expectations and can serve as a reminder to instructors of the most important points that they need to cover. the interrelatedness of the modules covered should be referenced as each session closes, which should be connected back to the vision and goals of the workshop (rule ). the learning objectives can be defined as the specific skills that participants will learn during the workshop. in a git workshop, the learning objectives might include creating branches as well as pushing to or pulling from remote repositories. the workshop's main learning objectives could be presented as an overview at the workshop's opening, along with introducing the instructors, the overall schedule, and a discussion on the code of conduct. however, the learning objectives should also be emphasized during and after each module and recapitulated during the workshop's closing remarks. at the beginning of each training module, instructors should clearly describe learning objectives and the skills acquired during this session (table ) . a record of learning objectives should be provided in a document specifying low-level objectives (e.g., learning the commands "ls" and "cd") as well as high-level workshop goals (e.g., learn to use commands together for automation of computational tasks). sharing these documents ensures all instructors are made aware of other sessions' objectives, avoiding overlap or gaps in knowledge across sessions. data science workshops will have a blend of conceptual overviews (e.g., why a particular set of technologies is used and how they fit together), best practices (e.g., why containerization is useful for reproducible computing), and technical hands-on exercises (e.g., pulling docker containers and creating new dockerfiles). across the developed training modules (rule ), active learning helps participants understand the rationale behind learning objectives and technical choices of the module (rule ). felder and brent ( ) define active learning as anything course related that all students in a class session are called upon to do rather than simply watching, listening, or taking notes [ ] . in addition, the instruction should provide learners not only with practice implementing technologies but also how to find help autonomously to resolve technical issues after the workshop adjourns. the active learning environment is enhanced by developing group or live coding problemsolving activities in a physical environment that facilitates cooperation (e.g., tables, computer displays and whiteboards, and breakout areas) [ ] . in online workshops, these activities can be done by creating small subgroups of participants working together or with individuals working simultaneously on the same problem set. it is essential to recruit helpers/facilitators familiar with the technologies to ensure adequate workshop pacing and assist with unforeseen technical problems [ ] . additionally, it is important to allow for helpers and facilitators to easily move between individuals/groups and track their progress, which can be particularly challenging to monitor in an online setting. instructors may underestimate the time required for an active learning module. this is especially challenging when instructing in a heterogeneous computing environment with multiple software code stacks. instructors should be mindful of the pace and watch for participants falling behind the rest of the group. it is important to ensure participants feel comfortable in speaking out with their difficulties, which can be onerous in some online settings. it can be beneficial to encourage participants to keep their cameras on to ensure engagement and allow a better gauge of their status. this may be impossible with larger groups or with slow internet connections. additionally, we recommend providing instructions before the workshop on how to use interactive features of online video conference tools (e.g., attendees raise hands, polling, and breakout rooms). workshop participants are likely to come from diverse scientific backgrounds with varying levels of computational literacy. it is critical to understand their expectations and evaluate their skill sets to ensure that the workshop material and active learning sessions meet the needs of participants [ ] . in addition, instructors must have empathy for participants and consider the learner's expectations when conducting their presentations. when organizing virtual workshops, keep in mind that participants may have limited resources that can hinder their learning experience (such as having a small, single monitor, slow computer, or limited bandwidth). in addition, it is important to make sure that the workshop is accessible for all participants [ , ] . we recommend providing a pre-workshop survey to participants using the workshop goals (rule ) to shape the questions. if the workshop is part of a series, questions like "are you participating in the next workshop on topic x that builds from this content?" can better link workshop contents over disparate time scales. interested readers can find here an example of survey here: http://bit.ly/ds-qs. collecting participant's feedback allows instructors to better develop active learning modules matching the participants' domains of interest (rule ) and provide information for refining learning objectives (rule ). prior to your workshop, it is important to test new teaching materials with naïve users (defined as anyone with no prior experience) in the specific domain, software, or technique being taught. the material should be complete and be easily followed by someone who is new to the field. particular care should be taken during this test to ensure the lesson will fit in the allotted time. there should be no gaps in knowledge and/or lesson steps. review the connections of learning objectives for each module to the needs identified in a pre-workshop survey (rule ). while pretesting the learning material is critical for the workshop's success, it is also extremely time consuming. we therefore advise all instructors to deliver their material at least weeks prior to the workshop to ensure sufficient time for cognitive walkthroughs. the particularities of each operating system should be taken into account when the participant is expected to provide their own laptop. in particular, installation procedures should be detailed for each platform. if the learner is expected to complete the computational tool installation prior to the workshop, plan at least an hour or on the first day to ensure that all required software and dependencies are configured. if the workshop provides computers, a system support technologist should be available at the beginning of the workshop to help with any system issues [ ] . it is important to note that many data science tools and platforms are complicated stacks of software, which can be difficult to install from scratch. it may be important to preinstall these on computers used in the workshop or provide preconfigured virtual machines and/or containers (docker (https://www.docker.com/)/singularity (https://singularity.lbl.gov/)). the chosen toolset informs skill prerequisites for participants prior to a module being taught (e.g., linux command line, logging into remote servers, etc.). these skills will need to either be covered early in the workshop or be expected as workshop prerequisites. be mindful that workshop material should be understandable for all learners (their prior knowledge should be informed by rule ) . presentation slides should include the most important points, since oral comprehension can be augmented with written notes. it is important for instructors to speak slowly, clearly, and avoid "going off script." we define "going off script" to be the inclusion of technical material outside the scope defined by the workshop (rules - ). if instructors include steps not clearly documented in the supporting material, this could lead to confusion, take extra time, and be particularly difficult for nonnative language speakers. such areas can be identified before the workshop during cognitive walkthroughs (rule ). all instructors must understand that adding any additional information outside the written material and learning objectives of a module may be of little value to participants. participant questions may lead to an instructor "going off script," and while these discussions may be useful, the instructor should reserve the right to address their question during a dedicated time for questions and answers or one-on-one during a break. however, this is not meant to impose any restrictions on personal style of presentation. we strongly encourage presenters to find their own voice and not simply read bullet points on a slide. dynamic and interactive presentation is a skill that the instructors are practicing and honing while teaching these sorts of workshops. in addition to developing their own teaching material, the instructors should strive to reference external resources available to participants. these workshops often provide foundational skills, but adding links to external resources will empower participants to continue their learning according to their needs and interests [ ] . this also allows engaged or more advanced participants to access content beyond the scope of the workshop. in addition, these resources can be referenced if questions cause the module to go off script (rule ). the pre-workshop survey (rule ) ensures extra content is tailored to extend the participants' learning trajectory beyond the workshop. when all rules of workshop organization are met by the organizers, the participants will leave with a sense of starting a journey toward a new long-term goal for themselves or their research group. workshops are rarely developed perfectly from the onset; learning from past experiences is critical to improving workshop content. as such, it is important to have surveys for each module and the workshop as a whole [ ] . we recommend reserving time for these to be completed during the workshop. for example, if holding a multiday workshop, set aside minutes in the morning of each day to let participants review the previous day's modules. these day-by-day evaluations facilitate tracking potential issues and implementing possible course corrections. in addition, it is important to hold a blameless retrospective (table ) [ , ] . there are several ways to conduct a blameless retrospective, but generally, they should be critical, relaxed, and provide a forum to identify what worked well, what didn't work well, and what should be done differently the next time the workshop is taught. when the retrospective concludes, there should be a list of action items to help with the planning and execution of future workshops. these assessments should aim to inform the practice of the next workshop and provide guidance for the instructors, allowing them to revise their style and approach in the future, and therefore should be documented and made accessible for future instructors. this practice, and revisiting rules - at this phase, will ensure that organizers, instructors, and helpers continue to refine, rather than reinvent, prior workshops. in particular, workshop organizers should pay attention to differences in learning objectives between iterations of workshops. this practice allows instructors to not be as constrained by prior editions of the workshop, since computational tools and data science are rapidly changing fields. this paper was developed and written before the coronavirus disease (covid- ) pandemic, which has forced many workshops and training into a virtual environment. we believe that all of the rules presented here are still useful in guiding the organization and implementation of a workshop in a virtual environment but do not cover all the unique challenges remote training face. the presented rules aim to help create a well-organized workshop with clear intentions and an empathetic environment in which participants feel both productive and understood. this focus on accessibility is particularly important to reduce the personal distance inherent in online workshops. additionally, these recommendations should guide organizers to provide complete and accessible materials for reference, a point particularly important for remote teaching, where home life can frequently interrupt participation. although not discussed here, it is also worth noting that instructors of online workshops should design their teaching with an extra effort on interactivity and checking for participants' understanding frequently. there are many resources available to help increase interactivity of online workshops, and we encourage the reader to try and choose the platform and tools that best meet their needs. we cannot wait to read the simple rules papers summarizing what the community will learn about remote teaching during these exceptional times. computational thinking and literacy unmet needs for analyzing biological big data: a survey of nsf principal investigators ten simple rules for developing a short bioinformatics training course data carpentry: workshops to increase data literacy for researchers null effects of boot camps and short-format training for phd students in life sciences when do workshops work? a response to the "null effects" paper from feldon et al. [internet]. software carpentry performance-based assessment of graduate student research skills: timing, trajectory, and potential thresholds. stud high educ active learning: an introduction. asq high educ brief ten simple rules for organizing and running a successful intensive two-week course ten simple rules for running interactive workshops removing the barriers for students with disabilities: accessible online and webenhanced courses make online teaching accessible with inclusive course design. disabil compliance high educ ten simple rules for measuring the impact of workshops a review of small and large post-mortem analysis methods the authors would like to thank ua health sciences for their support of the data science fellows program at the university of arizona, cyverse (nsf dbi- ) for participation in and observation of their workshops, and the carpentries (https://carpentries.org/) for leading the charge in developing and delivering various computational workshops to help domain scientists learn the best practices and techniques for managing and analyzing their data. key: cord- -b tky authors: berger gillam, t.; cole, j.; gharbi, k.; hitchcock, m.; edwards, d.; brabbs, t.; lipscombe, j.; davidson, r.; rushworth, s. a.; steel, n. title: norwich covid- testing initiative: feasibility project evaluation date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: b tky background there is a high prevalence of covid- in university-age students, who are returning to university campuses. there is little evidence regarding the feasibility of universal, asymptomatic testing to control outbreaks in this population. this study aimed to pilot mass covid- testing on a university research park, to assess the feasibility and acceptability of scaling up to all staff and students. methods this was a cross-sectional feasibility study on a university research park in the east of england. staff and students ( , ) on the research park were eligible to participate. polymerase chain reaction (pcr) testing was offered to all participants. participants were offered swabs, which they self-administered over a two-week period. outcome measures included: uptake; drop-out rate; positivity rates; participant acceptability measures; laboratory processing measures. results / ( %) of those who registered provided at least one swab and of these, ( %) provided all four. / ( %) had all negative results. participants had one inconclusive result. there were no positive results. / ( %) participants responded to a post-testing questionnaire. / ( . %) of those who responded agreed that they would be interested in repeat testing in the future. conclusions repeated self-testing is feasible and acceptable to a university population. universities are considering methods of dealing with the transmission of covid- when students return to campus. students are likely to have a higher than average prevalence of infection ( ) and in particular, a high rate of asymptomatic infection ( ) . this population is also highly mobile and more likely to have a large number of social contacts ( ) . it remains unclear how an outbreak might evolve on a university campus, but modelling studies suggest that students are highly interconnected, indicating significant potential for infectious disease transmission ( , ) . colleges in the usa have already reported outbreaks among the student population, necessitating closure in some cases ( ) . the uk government is exploring community-wide testing for asymptomatic covid- infection as a potential health protection tool, to enable outbreaks to be identified and controlled early ( ) . a sage consensus statement has suggested that such a strategy might be useful in "well-defined higher risk settings", such as universities ( ) . this method is largely untested within a university setting, however. this pilot study was based in the norwich research park (nrp), which includes the university of east anglia (uea) and a range of business and research institutions. the study offered four covid- pcr swabs to all staff and students on the site over a twoweek period, with the aim of piloting communications, logistics and laboratory processes, and assessing participant acceptability in preparation for larger-scale testing. all participants living or working on the nrp were eligible to participate and were invited to join the study via an email cascade to staff and students. ethics approval (no. / - ) was obtained from the uea research ethics committee. a secure web application was developed and hosted by the school of computer science at the uea. participants registered on the web application and were invited to verify their email accounts. all those who verified their accounts were considered to have enrolled in the study. people participated in a pre-trial, in which they returned two swabs. for the main study, participants were offered four swab tests over two weeks. they collected swab kits, self-administered the swab and returned the test in pre-booked return slots. for the purposes of this report the pre-trial and main trial are considered as a single trial. swabs were processed in dedicated laboratory facilities at the earlham institute (ei) from monday to friday. copan liquid amies elution swabs (eswabs) were used for all participants. participant samples were tested for the presence of sars-cov- using a quantitative polymerase chain reaction (qpcr) assay. briefly, nasopharyngeal swab samples were pre-treated with a lysis buffer (cytiva) that disrupts human cells and viral particles to release nucleic acid into solution. following inactivation, rna was extracted using sera-xtracta virus/pathogen kit (cytiva) on a liquid handling platform (beckman nxp). rna extracts were amplified for detection of the target genes using a set of optimised primers and probes ( -ncov cdc eua kit, idt), and enzymes (qpcrbio probe -step go no-rox, pcrbioystems) in a real-time pcr system (quantstudio , thermofisher). the assay is qualitative with results assessed based on a threshold cycle (ct value) to determine outcome (positive, negative, insufficient) using a combination of ct value for the viral target (n ) and human internal control gene (rpp ) genes. positive and negative controls were included in every rna extraction and qpcr run for quality control. negative or inconclusive results were posted on participants' online accounts. a protocol for managing positive results was developed, including notifying participants and nhs track and trace by telephone, and advising participants to share their results with their gp. . 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 after the completion of the feasibility project, participants who had returned at least one swab were emailed a link to complete a short online participant feedback questionnaire, including questions on demographics and their experience of the project. groups were compared with chi-squared tests and free text responses were analysed by extraction of key themes. results are summarised in figures and and tables and . table includes all participants from the pretrial (n= ) and main trial (n= ). figure relates to the post-study participant survey (n= ). % of the eligible population enrolled in the study and % of these dropped out of the study prior to returning any samples. % ( / ) of participants who received at least one result returned all four swabs. participants received inconclusive result. all other results were negative (see figure ). all participants received at least one negative swab. participants had free choice over the method of returning swabs: pedestrian access sites were favoured over vehicle access sites. the post-trial survey found that the overall acceptability rating was . stars and % of participants would take up repeat testing if available. self-swabbing received the lowest score for participant acceptability ( % agree or strongly agree that taking the swabs was easy to do). % of responders to the post-trial survey were staff and % were students. . 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 , . there was no significant demographic difference between those enrolled but did not participate and those who did participate. . 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 an analysis of guidance documents provided for participants, including an instruction leaflet, standard emails and website text found an average flesch reading ease score of . . this indicates that material should be comprehensible to a person aged - years. the instruction leaflet for participants undertaking swabbing had a score of , which indicates greater readability. the text for participants opening an online account had a score of . , which indicates that the reader requires a university education to understand the text. participant acceptability was assessed in two rounds; first by encouraging email comments during the testing process and second by a formal questionnaire. key themes emerging from participant emails included eligibility and logistical questions. there were very few emails regarding the process of self-swabbing. participants ( %) responded to the survey. responders were generally positive about their experience of the project, and the overall mean response score was . stars out of . % of those who responded to the survey returned all four swabs. % of responders were working or studying onsite, with the rest working either partly or exclusively from home. . % of survey responders lived miles or less from the nrp. responders were not significantly more likely than all participants to have returned all swabs ( % and % respectively, p= . ). there were no statistically significant differences between those who provided all swabs (n= ) and those who provided fewer than (n= ) in demographics or any answers, including the mean response score ( . and . stars out of respectively, p= . ). of the responders who provided fewer than swabs gave a reason: ( %) were away during part of the study, and another ( %) forgot or were unexpectedly busy with other commitments. responders ( %) answered the free text questions ("is there any feedback you would like to share about any aspect of your participation in the project?" and "is there a reason why you were unable to take any selfswab samples?"). responses were generally positive and included requests for ongoing testing, feedback on results of the study and praise for organisation and response to enquiries. responders recommended clearer communication on the variability of time to receive results, as some interpreted a longer wait as being suggestive of a positive result. they also requested clearer instructions regarding packing samples. main findings of this study participants took and delivered their swabs over a two-week period. the relatively low uptake can be explained by the timing of the study during the summer break, the absence of staff from campus due to working-from-home policies and a short run-up to the study. nearly a quarter of participants dropped out of the study prior to returning any samples. the reasons for this were unclear from the evaluation, however there was no significant demographic difference between those who enrolled in the study but did not participate, and those who did participate. the sex distribution of the eligible population was not available, it is therefore not possible to determine whether the sample population ( % women) was reflective of the eligible population. the ethnic distribution of the study population was broadly reflective of the population of norwich: . % of participants were of asian, black, mixed or 'other' ethnicity, compared to . % for norwich ( ) . the study did not identify any false positives, despite this being considered a risk of universal testing ( ) . an analysis of guidance documents and participant emails indicates a need for clearer information tailored to the eligible population. the participant questionnaire revealed a high level of participant engagement and acceptability. combined with the low drop-out rate ( % of participants who returned at least one swab . 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 returned all four), this suggests that participants found self-swabbing and the collection and delivery of samples generally acceptable. the laboratory processed swabs during the study. lab processes were effective, with an average processing time of just over hours during the week. the reagent cost per test of £ . was for under , tests which were ordered quickly from outside the uk, and we would expect lower costs per test in a larger initiative. what is already known on this topic the evidence base for use of asymptomatic testing for covid- as an infection control measure remains limited. universal, repeat testing has been advocated however, as a means of avoiding lockdown ( ) . universities across the world are now considering universal testing despite the pitfalls of this strategy, which include false positive and negative tests, the difficulty of defining an active infection and significant cost ( ) . colleges in the usa have already reported outbreaks of covid- ( ) . modelling studies have indicated that the potential for covid- transmission in universities is significant, particularly shortly after the beginning of term when students return to campus ( , ) . they demonstrate that universal testing may have a significant impact on control of the virus, depending on the ability of the setting to implement other control methods ( ) . there is however, no published study of a universal programme for repeat testing for covid- on a university campus. what this study adds this pilot study indicates that universal testing on a university campus is both feasible and acceptable to the population. a strength of this study is that it trialled the feasibility of repeat testing for covid- in a relatively large, asymptomatic population within a research park and university campus. participants included both staff and students and the findings can be applied both to a larger study on the same site and to other university contexts. there was a high level of patient engagement with the study. this study has demonstrated that clear, consistent communications are necessary for helping participants to understand the need for testing and the process of undertaking and returning the test. both universal testing and the current national public health strategy of testing symptomatic people via a local testing site have strengths and weaknesses. the current national strategy of symptomatic testing is adequate when there are few cases in the community, and is cheaper in the short term, but risks allowing undetected spread of covid- when cases start to rise in a community. the main potential problem with universal testing is that it may generate false positives, and therefore unnecessary contact tracing and isolation. it is also more expensive in the short term. there were no false positives out of , tests in this study. the main advantage of universal testing is that it can identify infectious asymptomatic cases and isolate them before they can infect others in the community. this is a major benefit on a campus university expecting large numbers of students to come together in a community where isolation and social spacing may be challenging to maintain, and where the financial and reputational costs of responding to a major outbreak would be substantial. limitations of the study include the relatively low uptake and the low prevalence of covid- in this population, which meant that processes for managing positive results could not be tested. as this was a selfselecting cohort of university staff and students, motivation to participate may be higher than in the general population. the findings are generalisable to university staff but may be less generalisable to new undergraduates. this study used pcr swabs but acceptability of some alternative testing methods, such as saliva testing, may be even higher. . 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. 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 age-dependent effects in the transmission and control of covid- epidemics covid- social study: results release simulating covid- in a university environment the small-world network of college classes: implications for epidemic spread on a university campus colleges ask students to leave campus amid covid- outbreaks press release: £ million funding for quick result covid- test trials. department of health and social care multidisciplinary task and finish group on mass testing: consensus statement for sage. uk government. st covid- mass testing programmes universal weekly testing as the uk covid- lockdown exit strategy. the lancet covid- outbreak among college students after a spring break modelling testing frequencies required for early detection of a sars-cov- outbreak on a university campus. medrxiv : the preprint server for health sciences thanks to the volunteers who assisted with this project. thanks also to jeannette chin and members of the ei covid- testing initiative (neil shearer, naomi irish, chris watkins, alex durrant, suzanne henderson, leah catchpole, fiona fraser, tom barker, jose carrasco-lopez, geoff plumb). funded in part by uk research and innovation (ukri) biotechnology and biological sciences research council (bbsrc) core capability grant bbs/e/t/ pr . key: cord- -p y zeo authors: rhodes, scott d.; mann-jackson, lilli; alonzo, jorge; garcia, manuel; tanner, amanda e.; smart, benjamin d.; horridge, danielle n.; dam, cornelius n. van; wilkin, aimee m. title: a rapid qualitative assessment of the impact of the covid- pandemic on a racially/ethnically diverse sample of gay, bisexual, and other men who have sex with men living with hiv in the us south date: - - journal: res sq doi: . /rs. .rs- /v sha: doc_id: cord_uid: p y zeo persons living with hiv (plwh) may be at increased risk for severe covid- -related illness. our community-based participatory research partnership collected and analyzed semi-structured interview data to understand the early impact of the covid- pandemic on a sample of racially/ethnically diverse gay, bisexual, and other men who have sex with men living with hiv. fifteen cisgender men participated; their mean age was . six participants were black/african american, five were spanish-speaking latinx, and four were white. seventeen themes emerged that were categorized into six domains: knowledge and perceptions of covid- ; covid- information sources and perceptions of trustworthiness; impact of covid- on behaviors, health, and social determinants of health; and general covid- -related concerns. interventions are needed to ensure that plwh have updated information and adhere to medication regimens, and to reduce the impact of covid- on social isolation, economic stability, healthcare access, and other social determinants of health within this vulnerable population. the united states (u.s.) south continues to experience disproportionate hiv rates compared to other regions of the country and has been referred to as the "new" and "latest" u.s. hiv epicenter ( , ) . southern states account for an estimated % of new hiv diagnoses in the u.s. each year, despite having only % of the county's overall population. eight of the states with the highest rates of new hiv diagnoses, and nine of the metropolitan statistical areas with the highest rates, are in the south ( ) . north carolina (nc) consistently ranks among these top states for hiv diagnoses ( ) , and guilford county, located in the piedmont triad region of central nc, has consistently higher rates of hiv than nc and the u.s. overall ( , ) . guilford county ranks third out of the counties in the state for hiv per , , and its hiv incidence rate is % higher than the national rate ( ) . coronavirus disease (covid- ) is a new infectious disease caused by the novel severe acute respiratory syndrome coronavirus (sars-cov- ), which had not previously been reported in humans ( ) . manifestations range from asymptomatic infection to severe complications including pneumonia, acute respiratory distress syndrome, coagulopathies, immune system dysregulation, and death. covid- is highly contagious and has quickly spread globally. ( , ) the rst case of covid- in nc was identi ed on march , , and on march , nc declared a state of emergency ( ) . given the ongoing rise in community-acquired covid- cases in nc, on march , a statewide stay-at-home order went into effect that limited activities to those that were considered essential (e.g., health-, safety-, nutrition-, and sanitation-related), banned gatherings of more than ten people, and prioritized social distancing (staying at least feet away from other people) ( ) . the nc stay-at-home order was eased on may , , with a phased re-opening that continued to limit the types of businesses and institutions that could open and the sizes of gatherings. hiv infection, along with several other immunosuppressing conditions, might increase risk of severe covid- -related illness ( ) . although the underlying mechanism is not fully understood, this risk for plwh may be due to a reduction in lymphocytes, immune system dysregulation, or an increased in ammatory response ( ) . comorbidities that are becoming increasingly common among plwh, such as diabetes, chronic kidney disease, chronic obstructive pulmonary disease, and obesity, also increase the risk of developing severe illness from covid- ( ) . the burden of these risks may not be carried equally among all plwh. communities of color face disproportionate rates of hiv, and black/african american gay, bisexual, and other men who have sex with men (gbmsm) and black/african american transgender women have higher rates of hiv than any other group in the us ( , ) . in addition, black/african american and latinx plwh have lower rates of care linkage and retention and are less likely to be virally suppressed than white plwh ( ) . in addition, persons of color are also experiencing disparities related to covid- . as of june , black/african american and native american or alaska native persons have covid- -related hospitalization rates ve times that of non-hispanic white persons, and hispanic or latinx persons have covid- diagnosis rates four times those of non-hispanic white persons ( ) . these higher rates may be related to living conditions, work circumstances, and health disparities including insurance and healthcare access as well as higher rates of comorbidities that increase the risk of severe illness from covid- , which are shaped by the larger context of systemic racism and inequalities ( , ) . therefore, racially/ethnically diverse gbmsm living with hiv are a particularly vulnerable population when considering the risk and impact of covid- . despite the impact of covid- and potential for serious morbidity and mortality, little is known about the pandemic from the perspective of plwh themselves. our long-standing community-based participatory research (cbpr) partnership sought to qualitatively explore the impact of the covid- pandemic within a racially/ethnically diverse sample of gbmsm living with hiv. this rapid assessment was conducted by our cbpr partnership in nc that includes racially/ethnically diverse gbmsm living with hiv; representatives from public health departments, hiv service organizations, and clinics that serve plwh; and academic investigators. this partnership has an established history exploring and intervening on the health-related needs and priorities of vulnerable communities ( , ( ) ( ) ( ) . we collected qualitative data from participants who had completed months of participation in and had "graduated" from the wecare intervention. wecare is an evidence-informed intervention that improves hiv care engagement among racially/ethnically diverse gbmsm and transgender women living with hiv by reducing missed hiv care appointments and increasing viral suppression ( , , ) . wecare currently is being conducted in partnership with the regional center for infectious diseases (rcid) in guilford county, nc ( ) . rcid is funded by the ryan white hiv/aids program, health resources and services administration (hrsa), to serve low-income plwh who are uninsured or underinsured. rcid provides comprehensive integrated services for plwh, including hiv primary medical care, case management, bridge counseling, nancial assistance, behavioral health care, community outreach nursing, and a dental clinic. the details of the wecare intervention are described elsewhere ( , , ) ; brie y, wecare harnesses social media platforms, including facebook messenger, text messaging (including through applications or "apps" such as whatsapp), and messaging through gps-based mobile apps used for social and sexual networking (e.g., a a/radar, badoo, grindr, jack'd, and scruff) to improve linkage to and retention in hiv care among plwh. the intervention is targeted to racially/ethnically diverse gbmsm and transgender women living with hiv, tailored to the social media platform preferences of participants, and personalized to each participant's needs ( ) . eligibility criteria to participate in wecare include: being age or older, identifying as cisgender male or male-to-female transgender, reporting sex with men, and living with hiv. potential participants are referred to the study by clinic and health department staff. we also advertise the intervention study on facebook through paid targeted advertisements and on other social media platforms, in a southeastern lgbtq (lesbian, gay, bisexual, transgender, and queer) newspaper, and through yers posted within bars, clubs, and coffee shops. furthermore, we recruit participants through word-of-mouth; enrolled participants are encouraged to share information about the study with others in their social networks. if eligible and interested, participants complete written informed consent procedures and enroll. participation in the intervention lasts months, after which participants graduate from wecare. of the graduated wecare participants, we randomly selected and contacted of them to complete an interviewer-administered semi-structured individual interview. the abbreviated interview guide is outlined in table i . demographic questions included some close-ended items; however, most questions in the interview guide were open-ended to allow participants to describe their experiences, perceptions, and attitudes. a trained bilingual interviewer conducted the interviews in english and spanish via telephone between april and may , . interviews were recorded and professionally transcribed. constant comparison, an approach to grounded theory, was used to analyze data. constant comparison combines qualitative coding with simultaneous comparison; initial observations are continually re ned throughout data collection and analysis ( ). because of the formative nature of this study, we aimed to identify the breadth of experiences, not to quantify them. analysts coded transcripts and developed matrices to identify similarities and differences within and across interviews. based on these matrices, each analyst developed preliminary themes. after preliminary themes were developed, the analysts came together via webex (a web-conferencing platform) to discuss and reconcile nal themes. human subject approval and oversight was provided by wake forest school of medicine institutional review board (irb). fifteen racially/ethnically diverse cisgender men participated; no participants refused to participate. participant mean age was . six participants were black/african american, ve were latinx, and four were white; all latinx participants completed their interviews in spanish. one participant self-identi ed as bisexual; all others self-identi ed as gay. eleven participants self-reported being virally suppressed while four reported not knowing whether they were virally suppressed. table ii . participants knew a great deal about covid- and its transmission. they were aware of recommended precautions to prevent infection, including wearing a face covering, social distancing, and handwashing. many were aware of the nc stay-at-home order that was in effect at the time of the interview and reported adhering to the order. for example, a participant reported, it's contagious. it affects the respiratory system. it can be fatal in some cases, but some people get through. it's important to take precautions and stay at home like the governor says. (participant [p] , black/african american, years old) another participant noted, "es un virus muy contagioso, que se transmite de una persona enferma si está muy cerca cuando tose. también, si la persona enferma toca algo, y la persona sana toca la misma super cie, se puede contagiar." ["it is a very contagious virus that is transmitted from a sick person if they are very close when they cough. also, if the sick person touches something, and the healthy person touches the same surface, it can be contagious."] (p , latinx, years old) covid- is perceived as serious, and participants perceive themselves to be susceptible participants reported that covid- was serious and that those with compromised immune systems were especially at risk. they were worried about their own increased risks as plwh and noted that hearing about others who had similar characteristics to them being seriously affected also increased their concerns. a participant stated, creo que es muy serio porque nunca en mi vida había visto algo así. afecta a las personas que tienen el sistema inmunológico comprometido como personas con diabetes o con problemas respiratorios, así que es muy serio. uno piensa que porque uno es joven no le va a pasar, pero estamos viendo casos de jóvenes que han muerto por este virus y eso lo hace más grave para mí. [i think it is very serious because i have never seen anything like this in my life. it affects people who have compromised immune systems like people with diabetes or respiratory problems, so it's very serious. you think that because you are young it will not happen to you, but we are seeing cases of young people who have died from this virus and that makes it more serious for me.] (p , latinx, years old) another participant said, "the coronavirus is making me super cautious. i am just afraid to contract it so i think about it a lot, but i try to stay optimistic about the entire situation." (p , black/african american, years old) participants also reported worrying about the well-being of friends and family members, particularly those who were older, had comorbidities, or had other risk factors for developing serious illness from covid- . a participant noted, "pues, estoy muy preocupado por toda mi familia y mi círculo porque no solo me puede afectar a mí, sino a toda mi familia también. participants found available and prevailing information regarding the transmission and prevention of covid- to be con icting. social media (e.g., facebook), the internet (e.g., cdc website), and television (e.g., english-and spanishlanguage national and local news) were noted as places that participants obtained information about covid- . participants also reported that they received information from their workplaces, as guidelines and regulations changed and thus required changes to how work was performed. for example, participants who worked in restaurants noted that they learned about transmission, prevention, and the current state of disease burden from restaurant owners and managers. in addition, participants described friends and family as sources of information about covid- . a participant reported, "i get info on tv, and i did some research on the internet, read some articles, and heard some through word-of-mouth, like during a meeting at work when we go over protocols and changes that are going into effect because of the coronavirus." (p , white, years old) another participant agreed saying, "i honestly do not trust anything that the president says." (p , black/african american, years old) a third participant stated, "no confío mucho porque creo que no le tomaron mucha importancia cuando empezó y por eso estamos con estos números tan altos." ["i do not trust much, because i think they did not take it seriously when it started and that is why we have these high numbers."] (p , latinx, years old) healthcare providers, including hiv providers, were identi ed in particular as providing timely and trustworthy information about covid- . a participant stated, "i trust my doctor, especially because i believe they have the best interest at heart and they are the people on the frontline. they are telling us what they understand and what they are seeing from their patients." (p , black/african american, years old) participants are taking action to reduce their risks participants reported staying home, maintaining social distancing, and cleaning with disinfectants and sanitizers to prevent contracting covid- . a participant commented, "i have not been out. today is actually the rst time i went out to go to the store. no hugging anyone; i try to stay away from people as much possible or at least six feet." (p , black/african american, years old) this commitment to prevention was noted by other participants. for instance, a participant stated, "i have been extremely social distancing. i, in fact, haven't left my house; some of my friends do the grocery shopping for me and leave my groceries by the door. i bring them inside, sanitize them, and throw the bags out." (p , black/african american, years old) further, another participant noted, "guardo mi distancia entre las personas cuando salgo a la tienda, uso desinfectante de alcohol en mis manos, mascarilla cuando salgo afuera, y limpio con desinfectante las áreas que más toco como el refrigerador, las llaves, mi tarjeta de débito, y las mancillas de la puerta." ["i keep my distance from people when i go out to the store, use alcohol disinfectant on my hands, a mask when i go outside, and clean the areas i touch the most with disinfectant, such as the refrigerator, keys, my debit card, and the door handles."] (p , latinx, years old) participants noted that worries and fears related to covid- and behavioral changes that they are making to stay safe are affecting them in both negative and positive ways. a participant noted that he is sleeping less because he is worried about his health, the health and well-being of his friends and family, and the long-term impact of the pandemic locally and globally, reporting, "my sleeping schedule has been changing a lot. it is hard to sleep hours as i used to." (p , black/african american, years old). another participant commented, "i am working out less to avoid public settings." (p , white, years old) however, some participants reported positive changes they had made in their health behaviors as a result of staying home and other adaptations related to covid- prevention. a participant noted, "i stopped drinking alcohol because i gure that i have bad habits when i am at home alone; because in the rst week or so of the stay home order for the coronavirus, i was drinking a lot and that kind of hurt me." (p , white, years old). further, another participant shared, "i actually started meditating in the mornings so i can have a good set of mind about all this. and i have been spending more time in the backyard and gardening more than i did before." (p , white, year old) before the initiation of the covid- pandemic, participants were already communicating frequently through social media platforms such as facebook, texting, and gps-based mobile apps. after the pandemic began, however, participants reported increased use of these types of social media platforms. a participant noted, "i use facebook much more now because it is the only way we have to communicate with other people." (p , black/african american, years old) use of other technology for communication, such as video calls, also increased, as another participant added, "i don't see my friends and family much now, and if i do, we try to facetime on the iphone or call each other on facebook to see them on video. we talk on the phone to catch up. that is the only way we do it to be safe and cautious." (p , white, years old) participants reported that their mental health was profoundly affected by covid- and the necessary precautions required to reduce risks of exposure. a participant noted, "the changes make me feel hopeless and sad. i am just realizing that everyone wants things to go back to normal, but i think a lot of things will change, and lots of polices that are in place will change, like in restaurants and bars. it will never be normal." (p , black/african american, years old) another participant reported, "i do feel alone, and it kind of reminds me of when i learned that i had hiv." (p , white, years old) accessing medical care is more di cult participants reported that accessing medical care had become more di cult in the context of covid- . though as of the time of data collection participants had not experienced interruptions in their hiv care, some had not been able to get other needed care. as a participant reported, "it [covid- ] just makes things harder. i was not able to go to the dentist to take out my wisdom teeth because they do not do anything that is not a priority." (p , black/african american, years old). participants had also had challenges with virtual appointments (e.g., telemedicine). for example, a participant shared, "for the follow-up appointment i had to see the doctor through zoom, but he couldn't really see me and that made things more challenging, especially because the technology wasn't really working. things are more complicated now." (p , black/african american, years old) overall, participants reported obtaining hiv medications as needed since the initiation of the pandemic. however, they did report that adhering to medication regimens had become more di cult. a participant shared, "it's been easy to get the medications because the pharmacy sends them, but it has been challenging to take them as i should because i had a routine before. i used to take my medication every day at work, but since i am working from home, i can't follow the same routine." (p , white, years old) participants reported multiple ways in which covid- affected them through social determinants of health. first, some participants noted that they had lost educational opportunities. a participant reported, "i was supposed to have an internship this summer and make money. it's been very stressful, and i am not having a good summer." (p , black/african american, year old). another participant described losing his job, "i have been laid off from work till further notice, so i have not been working. so it is affecting me that way." (p , white, years old) participants felt the nancial impact of job losses on other social determinants, such as housing stability. a participant shared, "ya empiezo a tener di cultad; no sé cómo voy a hacer este mes para pagar mi renta." ["i am already having di culty; i don't know what i am going to do this month to pay my rent."] (p , latinx, years old) participants who had jobs and were able to continue working during the stay-at-home order felt fortunate to be able to maintain an income. however, they also worried about exposure to covid- when ful lling roles as essential workers. a participant noted, "i think what makes it challenging is that i work in the public and interact with people every day, and i am not sure where they have been and if they have covid- or not. i just think that interacting with people who might have it on a daily basis makes it hard." (p , black/african american, years old) participants reported a reduction in in-person social support. a participant noted, "it is affecting my interactions with other people; i do not see my family and friends anymore." (p , white, years old). another remarked on his loneliness saying, "there are times when i think, if i had a boyfriend or a roommate, someone that at least can stay in quarantine with me, that will be better. i mean, i have a cat, but it is just hard sometimes." (p , white, years old) the economy and its impact on self, families, and friends are concerns participants also reported worrying about the long-term implications of the pandemic for local, regional, and global economies. as a participant shared, my biggest concern is [that] the way that it is happening here will have a devastating impact on the economy, just because it's been so bad. i have such a big fear that this will reach areas of underdeveloped counties where the health system is even weaker than ours, and they will not be able to handle that. in addition, i think that when the economy is not doing well in america, the whole world economy falls after that. (p , black/african american, years old) participants also worried that states may be re-opening businesses and institutions before the covid- pandemic was under control, which could lead to more transmission. as a participant noted, "they are leaving it to the states to reopen or not, so i am worried about its [covid- ] being spread." (p , white, years old) discussion plwh may be at increased risk for severe covid- -related illness. in this qualitative study of a sample of racially/ethnically diverse gbmsm living with hiv, we identi ed themes that we grouped into six domains. several ndings deserve further attention. first, participants had high levels of knowledge about the transmission and prevention of covid- . while participants reported some confusion about con icting and emerging information related to covid- , they utilized multiple and credible sources to obtain information about the pandemic and risk reduction. this nding could re ect, in part, their past participation in the wecare intervention, which improves health literacy by helping participants identify, evaluate, and use online sources of health information, including cdc and hrsa websites ( , , ) . thus, despite our sample knowing quite a bit about covid- , many plwh may need support in identifying and accessing correct and updated information to manage their health in light of the dissemination of con icting information regarding covid- . further, hiv healthcare providers were identi ed as highly trusted sources of information about covid- . providers must make time to assess covid- -related information needs, correct misinformation, and support risk reduction among their patients living with hiv. participants did not, however, trust information provided by u.s. president. participants distinguished between the veracity of information about covid- provided by the u.s. president and information about covid- provided by other government leaders such as dr. anthony fauci, the director of the national institute of allergy and infectious diseases (niaid) and a member of the white house coronavirus task force. it is important to note that this study was conducted early in the covid- pandemic, and many participants had not yet navigated medical care, such as a routine o ce visit for hiv care, since the implementation of changes in care delivery related to covid- . however, some participants reported having non-urgent healthcare visits canceled or postponed, and those participants who had obtained care reported not being satis ed with telemedicine appointments. covid- has required acceleration of telemedicine, and much is being learned about how best to provide care using this distance platform ( ). as telemedicine becomes more widespread, concerns about con dentiality, access to and quality of care, reliable internet access, and health disparities must be considered. in our research with gbmsm living with hiv in the u.s. south, we have found that most own or have access to smartphones; however, most do not have access to desktop computers or laptops at home. thus, they may not have the requisite technology and/or a private place to participate in telemedicine visits that utilize a video component ( , , , , ) . transition to telemedicine could potentially reduce hiv care engagement and viral suppression and increase disparities among some of the most vulnerable populations living with hiv. current efforts to improve telemedicine technology and the integration of telemedicine into clinic settings should include targeted efforts to meet the needs of vulnerable populations, including plwh. moreover, while covid- did not seem to affect access to hiv medications in this study, the impact of the pandemic affected adherence to medical regimens. interventions may be needed to help plwh strategize how and when they can take their hiv medications given interruption to their routines due to covid- (e.g., changes in job and school schedules). plwh may be particularly affected by covid- because they may already be experiencing stigma and isolation related to living with hiv ( ) . participants noted that living through the covid- pandemic felt like when they rst learned of their hiv status, with similar feelings of loneliness and having no one to turn to. they reported limiting their interactions with others to reduce their risk of exposure; however, they subsequently reported feeling alone, isolated, and in need of social support. these feelings can lead to hopelessness and depression and negatively affect medication adherence and health outcomes ( ). to address these challenges, interventions may be needed to bolster social support among plwh while maintaining social distancing. given that participants reported using social media at increasing levels since the initiation of the pandemic, approaches that leverage these platforms, such as those used in wecare, may hold particular promise in this context. participants also noted that the covid- pandemic resulted in missed educational opportunities, job loss, and nancial hardship. moreover, their worries were broad; they expressed concerns about themselves as well as others who they care about and the impact of the pandemic on the global economy. interventions are needed to address the varied and pervasive harms, health-related and otherwise, caused by the covid- pandemic on plwh, and also the underlying social determinants of health that can make plwh more vulnerable to these harms. it is important to note that participants in this study do not re ect the entire population of plwh or plwh in the u.s. south. participants represented a unique sample and may have bene ted from their participation in wecare. further studies are needed with participants that have not participated in such an intervention. we also note the small sample size; however, we purposefully recruited a racial/ethnically diverse sample and terminated data collection when we reached saturation. we also note that we wanted to better understand the breadth of experiences of plwh; future studies should focus on quantifying the experiences identi ed and developing targeted interventions for plwh based on these ndings. this study was designed to be a rst, early step. this study tapped into a small group of racially/ethnically diverse gbmsm living with hiv. it lays the foundation for future research exploring both the immediate and long-term impacts of the covid- pandemic among gbmsm living with hiv. additionally, there is profound need for novel interventions to address the impact of the covid- pandemic on social isolation, economic stability, access to health care, and other social determinants of health for racially/ethnically diverse gbmsm living with hiv. because increased age is a risk factor for severe illness from covid- , and nearly half the plwh in the u.s. are over ( ), further indicating the potential of severe covid- -related illness among this population, there is also need for targeted research to understand the impact of the pandemic on older plwh and interventions to support older plwh's needs related to covid- . these data were collected within the rst three months after the rst covid- case was reported in nc and provide important insights about the impact of this rapidly emerging public health issue. since then, new developments have occurred, including a statewide mandate requiring the use of face coverings in public places that went in to effect in nc on june , . at the same time, while participants reported engaging in prevention behaviors initially, their adherence with social distancing, face coverings, and use of disinfectants and sanitizers may decrease over time as fatigue sets in. it will be important to build on these early ndings within the continually changing context in terms of covid- infection rates, economic impacts, and state and federal government responses. the authors declare that they have no con ict of interest. all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board of the wake forest school of medicine and with the helsinki declaration and its later amendments or comparable ethical standards. this article does not contain any studies with animals performed by any of the authors. informed consent was obtained from all individual participants included in the study. the economy and its impact on self, families, and friends are concerns states may be "opening up" too quickly southern states are now the epicenter of hiv/aids in the us. the washington post centers for disease control and prevention. hiv in the southern united states nc: guilford county department of health & human services social support and other factors associated with hiv testing by hispanic/latino gay, bisexual, and other men who have sex with men in the north carolina hiv/std surveillance report north carolina department of health and human services pathophysiology, transmission, diagnosis, and treatment of coronavirus disease evaluation and treatment coronavirus the burden of covid- in people living with hiv: a syndemic perspective north carolina identi es first case of covid- . raleigh, nc: nc department of health and human services stay-at-home order issued for north carolina. the news & observer evidence used to update the list of underlying medical conditions that increase a person's risk of severe illness from covid- clinical outcomes and immunologic characteristics of covid- in people with hiv global, regional, and national estimates of the population at increased risk of severe covid- due to underlying health conditions in : a modelling study estimating the prevalence of hiv and sexual behaviors among the us transgender population: a systematic review and meta-analysis characterizing the impact of covid- on men who have sex with men across the united states in april hiv prevention interventions with adolescents: innovations and challenges in partnerships across the integrated transitions model coronavirus disease case surveillance -united states assessing differential impacts of covid- on black communities cbpr to prevent hiv within ethnic, sexual, and gender minority communities: successes with long-term sustainability preliminary impact of the wecare social media intervention to support health for young men who have sex with men and transgender women with hiv a randomized controlled trial of a culturally congruent intervention to increase condom use and hiv testing among heterosexually active immigrant latino men a social media-based intervention designed to increase hiv care linkage, retention, and health outcomes for racially and ethnically diverse young msm supporting health among young men who have sex with men and transgender women with hiv: lessons learned from key: cord- - eehtxin authors: rebmann, terri; english, judith f.; carrico, ruth title: disaster preparedness lessons learned and future directions for education: results from focus groups conducted at the apic conference date: - - journal: american journal of infection control doi: . /j.ajic. . . sha: doc_id: cord_uid: eehtxin background infection control professionals (icp) who have experienced disaster response have not been assessed in terms of the lessons they have learned, gaps they perceive in disaster preparedness, and their perceived priorities for future emergency response training. methods focus groups were conducted at the apic conference to evaluate icps' perceived needs related to disaster planning topics, products they feel are needed for education and reference materials, and lessons learned from past disasters. results icps' role in disaster preparedness and response is essential, even in noninfectious disease emergencies. infection control issues in shelters, such as overcrowding, foodborne illness, lack of restroom facilities, inadequate environmental cleaning procedures and products, difficulty assessing disease outbreaks in shelters, inability to isolate potentially contagious patients, and too few hand hygiene supplies can contribute to secondary disease transmission. other important topics on which icps need to be trained include surge capacity, employee health and safety, incident command system, educating responders and the public on disaster preparedness, addressing changing standards/recommendations, and partnering with public health. icps need quick reference materials, such as checklists, templates, tool kits, and algorithms to better equip them for disaster response. conclusion infection control must continue to partner with public health and other responding agencies to address gaps in disaster planning. in , the united states experienced disasters that cost more than $ billion each in damages and made it the second highest year in terms of the number of natural disasters occurring in a single year. similar experiences have occurred around the world in the past few years. natural environmental disasters, such as hurricane katrina in the united states and the tsunami in asia; infectious disease disasters, such as the anthrax bioterrorism incident in the united states; plus the outbreak of severe acute respiratory syndrome (sars) in canada and other countries have illustrated the tremendous medical, social, and economic impact a disaster can have on any country. historically, infection control professionals (icp) have responded to health care-associated infections and public health infectious disease outbreaks. beginning in the late s, many icps expanded their role to become involved in bioterrorism preparedness planning. some recent disasters occurring in the early st century, such as sars and hurricane katrina, have illustrated the importance of icps becoming involved in planning and response for all types of disasters to decrease secondary morbidity and mortality. icps who have experienced disaster response have not been assessed in terms of the lessons they have learned, gaps they perceive in disaster preparedness, and their perceived priorities for future emergency response training. these icps' experiences should be assessed, and their lessons learned should be incorporated into development of reference materials and future training for icps. the purpose of this study was to evaluate icps' perceived needs related to disaster planning topics and products required for education and reference materials. specific aims of the needs assessment included the following: ( ) to determine disaster-related education products or reference materials, ( ) to prioritize disaster preparedness topics for future icp training and reference materials, and ( ) to determine lessons learned from past disasters. the authors developed the questions for this study. all members of the association for professionals in infection control and epidemiology, inc. (apic) who were registered for the national apic conference were invited to participate in the focus groups, regardless of age, race, gender, or work location (within or outside the united states). the only inclusion criteria were attendance at the apic conference and participation in a disaster response in the past. the authors recruited potential participants via phone calls and e-mail. one focus group met each day in a meeting room located in a hotel near the conference site on june , , and , . a meal was provided to the participants as an incentive for their participation. the nominal group method was used to elicit information on the topics of interest. the focus group method of using opening-ended questions was used to elicit details from participants' experience with disaster response as to why those categories were chosen and lessons learned from past disasters. participants were informed that information collected would remain anonymous and that all responses were voluntary. focus group sessions were audiotaped, and the tapes were transcribed verbatim. content analysis included identifying, coding, and categorizing participants' response to the questions of interest. in addition, major themes that emerged were identified and categorized. quotations that characterize the major themes are reported. the words enclosed in brackets of the quotations are used to explain the respondents' quotes and are not the participants' words. subjects' demographic data were obtained for descriptive statistics. the institutional review boards of st. louis university, national naval medical center, and university of louisville approved this study. apic headquarters funded the costs of the focus groups and audiotape transcription. annual educational conference were contacted. thirtytwo participants took part in the focus groups: the first focus group had participants, the second had , and the third had . a description of the participants' demographic characteristics is reported in table . focus group participants reported that they resided in states from across the united state; participants were from canada, and participant has worked in multiple countries. twenty-five participants ( . %) are certified in infection control. the participants reported that they had been involved in responding to a variety of types of disasters ranging from power outages and floods to terrorism and infectious disease emergencies; most ( %, n ) had been involved in the response to multiple events. the participants identified many types of education products/reference materials needed for future disaster response and disaster preparedness education topics on which the participants believed that icps need to be trained. the education products that received the most votes during the nominal group method portion of the focus groups are outlined in table . the education topics that received the most votes during the nominal group method portion of the focus groups are outlined in table . in addition, a number of themes emerged from the focus groups related to emergency preparedness issues encountered in previous disasters. one of the most frequently cited topics of importance to disaster planning was the need for better infection control in community-based shelters. focus group participants from a variety of types of disasters indicated that infection control was lacking in crowded shelters and that this contributed to secondary disease transmission. ''infection control in shelters is important. we had a child in a shelter in alabama, not [hurricane] katrina, but prior to that, with meningitis, and they'd been there for several hours, and no one realized they had been there. we needed fast treatment [to prevent secondary spread]. and there were outbreaks of diarrhea [in the shelters].'' ''when they set up these shelters, they really don't have any idea about what they're going to do for hundreds and hundreds of people [to accommodate] handwashing and [provide] restroom facilities.'' focus group participants listed some specific infection control issues that must be addressed in shelters, such as overcrowding, foodborne illness, lack of restroom facilities, inadequate environmental cleaning procedures and products, difficulty assessing disease outbreaks in shelters, inability to isolate potentially contagious patients, and too few hand hygiene supplies. by far, lack of hand hygiene supplies or the inability to perform hand hygiene was the most frequently cited infection control issue in community-based shelters. icps recommended that disaster planners arrange to have a dedicated individual(s) for hand hygiene and infection control in alternate care sites: ''[in disasters] there ought to be people that are just responsible for hand hygiene. i know we talk about it in the hospitals, and we push it, push it, push it, but really in a disaster. hand hygiene is probably the most important thing.'' icps stressed the need to perform real-time assessments during disaster response, including general disaster response needs as well as disease surveillance. ''in shelters and out in the community, [you need to] go and see: do they need food, do they need child care, do they need deceased care? you know, what do they need? do they need an ambulance to get someone to a higher level of care?'' ''you have to come up with a list of what everyone needs to run a clinic. how many bottles of disinfectant do we need, how are you going to mix it, where are you going to store it?'' icps also discussed the difficulty in assessing disease outbreaks during disaster response, even in noninfectious disease emergencies. ''you know the thing about disasters is that you see a lot of diseases that you don't get normally.'' ''one of the major problems i had immediately post one component of surge capacity that was stressed was staff surge capacity or the ability of a facility to have sufficient numbers of staff to handle an influx of patients. comments such as ''staffing is going to be a major issue'' illustrated the importance of this issue to participants. the number of available staff was mentioned as contributing to a facility's ability to stay open and provide patient care or halt routine procedures to accommodate disaster victims. ''the biggest [problem] i've seen [after a disaster hits]-and i've responded to many different kinds [of disasters]-is the staff wanting to leave. so your facility staff has just gone home to do something for their home, or to be with their family, and your nurses are trying to get out the doors, and only a basic crew is remaining. so how do you continue with your current, everyday operations when your staff just left?'' ''[surge capacity is] a big issue because we've got to switch over to responding to the disaster and then which of our routine services can we stop, and when do we need to restart those services?'' focus group participants discussed the importance of monitoring and managing employee health and safety issues during disaster response. doing so will have the advantage of maximizing staff surge capacity by keeping staff able to continue working without contributing to secondary disease spread. icps mentioned a number of employee health issues, such as monitoring staff's mental health, holding daily staff meetings to communicate how they were doing, providing adequate time for rest and sleep, having appropriate personal protective equipment, and ensuring food safety. one important component of employee health and safety is to teach staff to protect themselves before attempting to rescue disaster victims. as one participant explained, ''you have to take care of your staff. [sometimes] you have to stop what you're doing, which [in our case] was evacuating patients [from flooded areas], because. the staff was getting injured.'' if health care staff does not protect themselves before entering a potentially dangerous situation, ''you've got more casualties than when you started.'' another participant described a situation in which a physician could have potentially harmed himself by not following the appropriate procedures during a response to a possible anthrax incident: focus group participants discussed many problems and challenges related to the chain of authority in disaster response and use of the incident command system (ics). problems included a general lack of knowledge or experience with ics, inability of responding agency leaders to function within ics in noncommander positions, and reluctance on the part of individuals in command positions to make decisions. comments such as, ''i think that incident command is not very well-known or understood in general outside of [first responder groups]'' indicated that participants feel that hospital and public health staff needs additional training on ics. a frequently heard complaint was the difficulty of trying to function within the ics when responding agency leaders were assigned to noncommander positions. this led to mixed messages being communicated to staff and general confusion because no one knew who was in charge. this problem was mentioned in relation to a variety of disasters. ''we had the major blackout in new york city, and . nobody knew who to answer to, nobody knew who was responsible, who was in charge.'' ''i think it all goes back to . the chain of command, and who really is in charge. if you don't know who's in charge of your facility and people are trying to make a decision and they each have their own little miniagenda [it's confusing]. . d.c. is a phenomenal example of [a jurisdiction with many responding agencies] . there's many, many, many chiefs.'' ''[after hurricane] katrina . everybody wanted to be in charge, but then when they were in charge, nobody knew what they wanted to do.'' although the ics is intended to streamline disaster response communication and reporting, focus group participants pointed out that it only works when staff know the system and everyone follows the system appropriately. participants also discussed the advantages to the ics and the importance of being in compliance. they stressed that responding agencies should be educated regarding why they need to follow the ics. one participant suggested explaining the financial appeal of following ics to a facility to get everyone on board: focus group participants frequently mentioned ''just-in-time'' training as vital to an effective disaster response. participants indicated that all responding staff will require some level of training during the disaster response, but they also stressed that disaster planners need to ''think outside the box'' in terms of the groups for which they plan just-in-time training. one participant described it in this way: ''it's not going to be health care workers that we're going to be Ôjust-in-timeÕ training with, it's probably going to be college students . so they can train the other volunteers. or it . may be families teaching families how to care for each other.'' participants indicated that just-in-time training can improve disaster response by decreasing dependency on the health care system, allowing health care to focus on the truly ill victims. they also stressed that it must involve public service announcements and should be coordinated through the ics' public information officer. these announcements should include information on ''what is recommended, [whether people should] shelter in place . whether [people should] go to the er or not.'' participants felt that communicating this information and training to the public will prevent '' , people [from] . show[ing] up at your hospital.'' focus group participants stressed that it is important to have education or reference materials that do not rely on electricity because power outages may occur after disasters. they emphasized that disaster responders need education or reference tools that are ''rechargeable in some way other than electricity,'' such as a personal digital assistant (pda) that uses batteries. another option suggested by focus group participants was to have paper versions of reference materials and notebooks for recording information. one participant described it this way: ''when we thought [hurricane katrina] was coming, we started bringing a bunch of notebooks, and we walked out the door with those, and then we were out of power for weeks. those notebooks were the only things we had. .'' focus group participants discussed the importance of icps partnering with public health in disaster preparedness because icps are often the liaison between public health and hospitals in a community. participants indicated that establishing a partnership between hospitals and public health enhances the entire community's ability to respond more effectively during a disaster. icps who had responded to various types of disasters mentioned this lesson learned. ''i think we learned from the last hurricane that [infection control's] interface with the county health department is so important. they become your best friend. i think that's a huge lesson, and i think that if we learned nothing else from that hurricane, we learned that.'' ''i think it's critical that both [infection control and public health] get together and start way up front, knowing who the people are that are working at the health department in the kind of areas that are going to affect you, and we in health departments have to find our partners in the private side, so we get [disaster planning] done up front, and we know each other and we plan together.'' icps also stated that partnering with public health would bridge gaps in public health's knowledge of infectious disease emergency planning and foster the reciprocal sharing of information. icps felt that some public health professionals ''are not very well trained'' on communicable disease issues ''because they're so stretched in everything they have to cover, they don't necessarily have the expertise in infection control and infectious diseases in all of the public health departments across the country.'' one participant stated that public health frequently calls their hospital during a disaster and asks, ''can you help us out with what we should tell the public about this and this and this?'' icps felt that they should share their expertise of infection prevention and control knowledge with public health, which would result in a better prepared community. shared training and participating together in disaster exercises were mentioned as ways that icps could share information and education with public health. participants indicated that working together through disaster exercises and training programs would strengthen the relationship between public health and icps. one participant described it in this way: ''[training and exercising together] made everybody on the same level, and everybody gets along better now after that.'' one challenge participants identified that was unique to infectious disease emergencies was the difficulty in maintaining staff compliance and trust in the face of changing practice recommendations/standards. this was most evident in infectious disease emergencies involving a new agent (such as sars) or in a new situation (such as anthrax used in a bioterrorism attack as opposed to naturally occurring disease). icps indicated that disasters involving an element of the unknown and frequent changes to practice as likely to create an evolution of fear and mistrust in health care workers and first responders. focus group participants indicated that the fear of a potential avian influenza pandemic is causing many education and planning challenges in their facility and community. one of the biggest challenges is related to the unknown mechanism of transmission for avian influenza, resulting in conflicting guidance that has been released and the recommendation to change isolation precautions midway during the response to an outbreak. focus group participants stressed that changing recommendations and standards also have legal and ethical considerations. the general public does not always understand why medication recommendations (such as postexposure prophylaxis for anthrax) change, and this can be interpreted as discrimination in that it appears that health care and public health are providing a lower standard of care for different victims. one participant described the challenges and potential legal consequences of changing recommendations/standards midway through disaster response this way: the focus group discussions provided several important findings. information provided by the focus group participants highlights a number of educational/reference materials that are needed for future disasters. most of these consist of quick reference materials, such as checklists, templates, charts, tool kits, and algorithms. participants recommend that these materials be available in paper versions or electronically using products such as pdas that do not require electricity so that they may be accessed during times when electricity is not available. participants also provided a list of educational topics for icps. mass casualty incidents, infection control during disasters, communication, incident command, physical plant needs, improving health care worker basic knowledge of how infectious organisms are transmitted, and business continuity issues were all identified as being essential training topics. icps' role in disaster preparedness and response is considered to be essential, regardless of whether it is an infectious disease emergency, such as outbreak of an emerging infection or bioterrorism, or a natural disaster such as a hurricane or earthquake. although icps are essential to disaster preparedness and response, icps indicate that participation is not always easy. icps' role in disaster response can be complicated by a lack of supplies, inability to conduct real-time surveillance, difficulty in communicating information between facilities, too few staff, need to provide training to nonhealth care individuals, and challenges in functioning within the ics. disasters involving an element of the unknown, such as an outbreak of a new or reemerging pathogen, increase the difficulty in response. changing standards and recommendations must be communicated carefully to prevent mistrust among the staff and/or the general public. failure to do so can impinge on a facility or community's ability to mount an effective disaster response. another notable finding from this study is that even natural disasters can result in significant public health crises if infection prevention and control strategies are not implemented rapidly and appropriately. infectious disease outbreaks following disasters can devastate a community, and icps' expertise is needed to help prevent secondary spread within alternate care sites as well as their facility. to be most effective, icps need to partner with public health professionals in their region before a disaster and establish strong linkages between hospitals and community agencies. these partnerships can strengthen facility preparedness and maximize a community's ability to respond to a disaster. they should also result in stronger health care and public health systems by strengthening surveillance, communication, and basic infection prevention and control needed for day-to-day duties as well as disaster situations. overall, the focus group method of inquiry served as a valuable tool in eliciting rich, detailed information about icps' opinions of lessons learned from past disasters. structured surveys with closed-ended responses opposed to the open-ended questions used in this study may have revealed different opinions about references materials needed for future disasters and educational priorities for icps. it is not known whether the icps who chose to participate differed from those who were eligible but chose not to participate. it is also not known whether icps who have no experience with disaster response may have provided different answers compared with experienced icps in terms of preferred training topics and reference materials. however, this study was designed to elicit information from those who have responded to an actual disaster to identify gaps in preparedness in real situations rather than simulated events in disaster drills. icp preparedness for all types of disasters, especially infectious disease emergencies, has become essential. this study identifies lessons learned from past disasters and highlights gaps in disaster preparedness most in need of being addressed: infection control in mass casualty incidents, behavioral health issues, communication, incident command, and maintaining quality of care in suboptimal situations. disaster planners must continue to address gaps in disaster preparedness. one way to accomplish this is through the creation and distribution of icp-specific educational tools and reference materials for disaster preparedness and response. the topics identified by experienced icps should be used as the basis for these new educational initiatives. five billion-dollar disasters were recorded in infection control practitioners' perceptions and educational needs regarding bioterrorism: results from a national needs assessment survey nominal group technique: a user's guide focus group fundamentals the authors are the - chair and members of the apic emergency preparedness committee and this research was conducted in their role as members of this committee. a primary goal of this project was to provide information to be used in apic strategic planning and meeting membership and organizational needs. the authors thank the other members of the apic emergency preparedness committee who assisted in project development and design. the authors would also like to thank the focus group participants for their dedication to past and future disaster preparedness, as well as the time taken to participate in these focus groups. without your knowledge and experience, none of this would be possible. key: cord- - ozhdb authors: gholami, mohsen; napier, christopher; patiño, astrid garcía; cuthbert, tyler j.; menon, carlo title: fatigue monitoring in running using flexible textile wearable sensors date: - - journal: sensors (basel) doi: . /s sha: doc_id: cord_uid: ozhdb fatigue is a multifunctional and complex phenomenon that affects how individuals perform an activity. fatigue during running causes changes in normal gait parameters and increases the risk of injury. to address this problem, wearable sensors have been proposed as an unobtrusive and portable system to measure changes in human movement as a result of fatigue. recently, a category of wearable devices that has gained attention is flexible textile strain sensors because of their ability to be woven into garments to measure kinematics. this study uses flexible textile strain sensors to continuously monitor the kinematics during running and uses a machine learning approach to estimate the level of fatigue during running. five female participants used the sensor-instrumented garment while running to a state of fatigue. in addition to the kinematic data from the flexible textile strain sensors, the perceived level of exertion was monitored for each participant as an indication of their actual fatigue level. a stacked random forest machine learning model was used to estimate the perceived exertion levels from the kinematic data. the machine learning algorithm obtained a root mean squared value of . and a coefficient of determination of . in participant-specific scenarios. this study highlights the potential of flexible textile strain sensors to objectively estimate the level of fatigue during running by detecting slight perturbations in lower extremity kinematics. future iterations of this technology may lead to real-time biofeedback applications that could reduce the risk of running-related overuse injuries. running is one of the most popular and healthy activities [ , ] worldwide but carries a high risk of injury [ ] . long-distance running is, by nature, a prolonged and repetitive activity, which can induce fatigue. fatigue accumulates as runners increase distance or intensity and is defined as an exercise-induced reduction in the ability to generate muscle force or power that is caused by changes in the neural drive or exhaustion of muscle contractile function [ ] . fatigue is commonly measured either by direct physiological means (e.g., heart rate, blood lactate concentration, etc.) or by subjective rating of exertion. perceived rating of exertion is a subjective indication of fatigue that integrates information from the peripheral muscles, the central neural system, and the cardiovascular system [ ] . the borg rating of perceived exertion (rpe) scale [ ] is a popular and practical tool that has been widely used in running research [ ] [ ] [ ] . rpe scores are strongly correlated with blood lactate concentration and can be used both in the laboratory and in of kinematics is more challenging. the concept that increasing fatigue during a prolonged run is correlated with a change in kinematics is not new [ , , ] . assuming that the kinematic changes are as predictable (and progressive) as the level of fatigue, the fatigue level of a runner could be estimated by continuously monitoring their kinematics using a wearable device. from a machine learning perspective, the amount of information gathered from lower extremity kinematics may yield a better estimation of fatigue than monitoring kinetics or emg activity. as kinematic changes associated with fatigue may decrease performance and increase injury risk [ ] , the ability to monitor changes in kinematics over the course of a run, especially outside of a lab or clinic setting, has substantial implications on both performance and injury risk. two main methods have been used to measure changes in kinematics to detect fatigue: ( ) optical motion capture and ( ) wearable devices. wearable sensors have the advantage of unobtrusive measurement in ecologically valid environments during daily life. inertial measurement units (imus) are the primary wearable device that have been used to detect the state of fatigue or to quantitatively measure fatigue level. a machine learning approach has been used to estimate the level of fatigue based on information from wearable sensors, including strohrmann et al.'s [ ] investigation into the correlation of features extracted from imus with the level of fatigue during a prolonged run. there was a strong correlation between imu signal changes from imus mounted on the lower and upper body and the perceived level of exertion of runners. other studies have focused on the binary detection of the state of fatigue and non-fatigue based on measurements by imus [ , ] . tibia-mounted imus have obtained a high classification accuracy of fatigue during running and occupational tasks [ ] . karg et al. [ ] used a hidden markov model as a regression model to predict fatigue level during the performance of a squat exercise. this study monitored the kinematics of the lower and upper body using an optical motion capture system and obtained a high accuracy level. to our knowledge, the use of flexible textile (soft) strain sensors for continuous monitoring of fatigue has not yet been studied. flexible textile strain sensors are a category of wearable sensors that have recently been used for human gait analysis [ ] [ ] [ ] , trunk motion monitoring [ , ] , and hand gesture recognition [ ] . these sensors work by measuring changes in the resistance or capacitance when they are elongated [ ] . the advantages of flexible textile strain sensors are their easy integration into clothing and convenient use compared to rigid imus. in a previous study, we optimized a wearable flexible textile strain sensor system for three dimensional lower extremity joint angle measurement and subsequently validated this system for the measurement of lower extremity running kinematics [ ] . in this study, we extend our previous research to use flexible textile strain sensors for the estimation of fatigue level during running. our aim was to estimate the level of fatigue (measured by borg's rpe scale) during the course of a prolonged run based on the lower extremity kinematic information sensors , , of provided by the flexible textile strain sensors. we hypothesized that by using information from the flexible textile strain sensors and using a machine learning approach, we would be able to accurately estimate the level of fatigue at a given moment for an individual during a prolonged run. a resistance-based flexible textile strain sensor was employed in this study. the strain sensors were made of spandex multifilament yarn coated with a carbon black thermoplastic elastomer composite [ ] . the sensors were conditioned with sinusoidal strain of % at % per second before use. the sensor showed highly linear performance and no hysteresis in the working range of up to % strain. the sensor was then coated with an insulating sheath to prevent shortening of the circuit if participants sweat during the prolonged run. the sensor characteristics are summarized in table . the resistance-based strain sensor's fundamental work is expressed in equation ( ), where the resistance value is affected by the increase in the sensor's length: the sensor placement was optimized in a previous study [ ] and four positions were selected by genetic algorithm for a multi-axis hip joint. the positions of the sensors on the knee and ankle were selected according to the joint axes. the wearable system was validated for lower extremity joint angle measurement during running and showed an error of less than . • for multi-axis lower body kinematic monitoring during running [ ] . the prototype had a total of nine sensors: four sensors at the hip, two sensors at the knee, and three sensors at the ankle. however, one of the knee sensors was excluded from data processing because of high noise. the circuit used for data recording was a voltage divider circuit with a resistance of kΩ. participants were asked to run on a split-belt treadmill (bertec corporation, columbus, oh, usa) while the strain sensor signals were recorded at a frequency of hz by a data acquisition device. the prototype and the schematic of data processing are outlined in figure . the raw signals of the sensor did not drift over the course of min of running. similarly, the participant's sweat did not affect the performance of the sensor. five healthy, pain-free female recreational runners participated in this study. the selection of female participants was due to known differences in kinematics between male and female runners [ , ] . to obtain a homogenous sample, participants were selected based on running experience and recent performance in a -kilometer race. participants were also screened to ensure adequate fit of the prototype garment. onset of the covid- pandemic and the restrictions on in-person research limited data collection to a sample size of five. participants ran in standardized running shoes (new balance v , boston, ma, usa) to ensure that biomechanical changes were not due to differences in shoe characteristics. the use of the borg rpe scale was explained to the participants prior to the experiment. for consistency, participants were sensors , , of asked to report "the conscious sensation of how hard you are driving your working limbs and how strenuous the exercise feels at this point in time." after putting on the instrumented running tights, participants were given three minutes to warm up and become familiar with the treadmill, running at a steady speed of km/h. the treadmill was then stopped, and participants were asked to rate their current level of exertion on the borg rpe scale before commencing the test. data collection began with participants running at km/h. participants were asked to report their rpe score every three minutes. if the rpe score was lower than ("somewhat hard"), the speed was increased by km/h. once the participant reached an rpe score of , the speed was kept constant and they were asked to continue to report their rpe score every three minutes until they reported a level of ("very hard"). at this point, one more minute of data was recorded before terminating the test. figure b shows the individual changes in the participants' rpe scores during the test. five healthy, pain-free female recreational runners participated in this study. the selection of female participants was due to known differences in kinematics between male and female runners [ , ] . to obtain a homogenous sample, participants were selected based on running experience and recent performance in a -kilometer race. participants were also screened to ensure adequate fit of the prototype garment. onset of the covid- pandemic and the restrictions on in-person research limited data collection to a sample size of five. participants ran in standardized running shoes (new balance v , boston, ma, usa) to ensure that biomechanical changes were not due to differences in shoe characteristics. the use of the borg rpe scale was explained to the participants prior to the experiment. for consistency, participants were asked to report "the conscious sensation of how hard you are driving your working limbs and how strenuous the exercise feels at this point in time." after putting on the instrumented running tights, participants were given three minutes to warm up and become familiar with the treadmill, running at a steady speed of km/h. the treadmill was then stopped, and participants were asked to rate their current level of exertion on the borg rpe scale before commencing the test. data collection began with participants running at km/h. participants were asked to report their rpe score every three minutes. if the rpe score was lower than ("somewhat hard"), the speed was increased by km/h. once the participant reached an rpe score of , the speed was kept constant and they were asked to continue to report their rpe score every three minutes until they reported a level of ("very hard"). at this point, one more minute of data was recorded before terminating the test. figure b shows the individual changes in the participants' rpe scores during the test. five healthy, pain-free female recreational runners participated in this study. the selection of female participants was due to known differences in kinematics between male and female runners [ , ] . to obtain a homogenous sample, participants were selected based on running experience and recent performance in a -kilometer race. participants were also screened to ensure adequate fit of the prototype garment. onset of the covid- pandemic and the restrictions on in-person research limited data collection to a sample size of five. participants ran in standardized running shoes (new balance v , boston, ma, usa) to ensure that biomechanical changes were not due to differences in shoe characteristics. the use of the borg rpe scale was explained to the participants prior to the experiment. for consistency, participants were asked to report "the conscious sensation of how hard you are driving your working limbs and how strenuous the exercise feels at this point in time." after putting on the instrumented running tights, participants were given three minutes to warm up and become familiar with the treadmill, running at a steady speed of km/h. the treadmill was then stopped, and participants were asked to rate their current level of exertion on the borg rpe scale before commencing the test. data collection began with participants running at km/h. participants were asked to report their rpe score every three minutes. if the rpe score was lower than ("somewhat hard"), the speed was increased by km/h. once the participant reached an rpe score of , the speed was kept constant and they were asked to continue to report their rpe score every three minutes until they reported a level of ("very hard"). at this point, one more minute of data was recorded before terminating the test. figure b shows the individual changes in the participants' rpe scores during the test. two different methods were used to segment the strain sensor signals: ( ) based on strides and ( ) based on a moving window over the data. in method ( ), the peak values of the first sensor were detected and used to determine strides. in method ( ), the peak values of the first signal were detected two different methods were used to segment the strain sensor signals: ( ) based on strides and ( ) based on a moving window over the data. in method ( ), the peak values of the first sensor were detected and used to determine strides. in method ( ), the peak values of the first signal were detected and a window of time prior to this data point was selected. window lengths of . , , . , and seconds were examined. the window length of second obtained the best results ( figure ) . a set of statistical and temporal features were extracted according to the biomechanical changes of the lower extremity associated with fatigue. the features were: mean; minimum; maximum; range of motion; stride length-in addition, variation of mean; minimum; maximum; range of motion during the last strides/windows. moreover, the strides/windows were segmented to five subsegments and the mean, minimum, and maximum values of each sub-segment were extracted. the same features were extracted from the first derivative of the strain sensor's signals. random forest is an ensemble of decision trees that has shown promising results when compared with conventional machine learning algorithms including support vector machine and neural networks in regression and classification applications for strain sensor's data analysis [ , ] . random forest models are robust to outliers, nonlinear and unbalanced data, and produce low bias and moderate variance [ , ] . we have previously used random forest to accurately estimate joint angles using strain sensors [ ] . we therefore chose random forest as our method for data analysis. deep learning models were not employed for this study since they typically require large data sets for optimal performance and the limited data used in this study would not be favorable for those models. however, we have previously shown the potential of deep convolutional neural networks to predict joint kinematics if there are a substantial amount of data that allow the models to work efficiently [ ] . a two-step regression model (called the first and second model) was used for estimation with each random forest regressor having ensemble trees. the first model was trained using the extracted features from eight strain sensors and the second model was trained based on the predicted values of the first model. the first model was intended to make a rough estimation of exertion level while the second model could perfectly match the initial prediction to the reference value. the second model could particularly help in cases where the first model interpolated an rpe value between the scores that each participant reported during the test. considering that the rpe score of a participant is unlikely to vary over two successive strides, two subsequent voting windows with a length of samples were moved over the predicted fatigue level and the median predicted value under the windows was considered as the fatigue level. the value selected by the window was then rounded to result in an integer rpe score. a set of statistical and temporal features were extracted according to the biomechanical changes of the lower extremity associated with fatigue. the features were: mean; minimum; maximum; range of motion; stride length-in addition, variation of mean; minimum; maximum; range of motion during the last strides/windows. moreover, the strides/windows were segmented to five sub-segments and the mean, minimum, and maximum values of each sub-segment were extracted. the same features were extracted from the first derivative of the strain sensor's signals. random forest is an ensemble of decision trees that has shown promising results when compared with conventional machine learning algorithms including support vector machine and neural networks in regression and classification applications for strain sensor's data analysis [ , ] . random forest models are robust to outliers, nonlinear and unbalanced data, and produce low bias and moderate variance [ , ] . we have previously used random forest to accurately estimate joint angles using strain sensors [ ] . we therefore chose random forest as our method for data analysis. deep learning models were not employed for this study since they typically require large data sets for optimal performance and the limited data used in this study would not be favorable for those models. however, we have previously shown the potential of deep convolutional neural networks to predict joint kinematics if there are a substantial amount of data that allow the models to work efficiently [ ] . a two-step regression model (called the first and second model) was used for estimation with each random forest regressor having ensemble trees. the first model was trained using the extracted features from eight strain sensors and the second model was trained based on the predicted values of the first model. the first model was intended to make a rough estimation of exertion level while the second model could perfectly match the initial prediction to the reference value. the second model could particularly help in cases where the first model interpolated an rpe value between the scores that each participant reported during the test. considering that the rpe score of a participant is unlikely to vary over two successive strides, two subsequent voting windows with a length of samples were moved over the predicted fatigue level and the median predicted value under the windows was considered as the fatigue level. the value selected by the window was then rounded to result in an integer rpe score. the extracted features were fed into a random forest algorithm and the performance of the model in a five-fold cross-validation method was investigated. two different metrics were used to compare the performance of the machine learning regressor: r-squared (r ) value and root mean squared error (rmse) values. table shows the performance of the algorithm for five participants based on the window-based segmentation method. an average r value of . and an rmse of . were obtained with this method. figure shows the predicted and reference first and second model rpe scores during the prolonged run for all participants. the estimated values calculated by the first model are scattered around the reference value. however, the final prediction followed the reference rpe score. the rpe score did not follow a progressive increase during the prolonged run for participants and , yet the predicted values follow the changes in the participants' rpe scores. the extracted features were fed into a random forest algorithm and the performance of the model in a five-fold cross-validation method was investigated. two different metrics were used to compare the performance of the machine learning regressor: r-squared (r ) value and root mean squared error (rmse) values. table shows the performance of the algorithm for five participants based on the window-based segmentation method. an average r value of . and an rmse of . were obtained with this method. figure shows the predicted and reference first and second model rpe scores during the prolonged run for all participants. the estimated values calculated by the first model are scattered around the reference value. however, the final prediction followed the reference rpe score. the rpe score did not follow a progressive increase during the prolonged run for participants and , yet the predicted values follow the changes in the participants' rpe scores. the importance of the different sensor locations was evaluated by relative changes in r while excluding all the features that were extracted from a specific sensor ( figure ). greater negative values represent increased importance of a sensor. comparing the importance of each sensor across all participants indicated that the changes in kinematic parameters between different participants were the main difference. however, on average, the sensors placed on the hip reported a greater relative reduction in r value. the importance of the different sensor locations was evaluated by relative changes in r while excluding all the features that were extracted from a specific sensor ( figure ). greater negative values represent increased importance of a sensor. comparing the importance of each sensor across all participants indicated that the changes in kinematic parameters between different participants were the main difference. however, on average, the sensors placed on the hip reported a greater relative reduction in r value. to better understand how changes in kinematics at different joints contribute to the overall estimation of fatigue, features from the sensors on the hip, knee, and ankle were individually fed into a random forest machine learning algorithm. table shows the results of this analysis using the same two-step regressor. the results from using only the hip sensors are close to the overall accuracy, with only a . reduction in the coefficient of determination (r ) and . increase in rmse. however, the results when only relying on the knee or ankle sensors were substantially worse. the ankle sensors contributed less than other joints and could only obtain an r of . . to better understand how changes in kinematics at different joints contribute to the overall estimation of fatigue, features from the sensors on the hip, knee, and ankle were individually fed into a random forest machine learning algorithm. table shows the results of this analysis using the same two-step regressor. the results from using only the hip sensors are close to the overall accuracy, with only a . reduction in the coefficient of determination (r ) and . increase in rmse. however, the results when only relying on the knee or ankle sensors were substantially worse. the ankle sensors contributed less than other joints and could only obtain an r of . . table . the coefficient of determination and root mean squared value of predicted values while using a single joint sensor with standard deviations. in this study we investigated the ability of flexible textile wearable sensors to monitor and predict the rating of perceived exertion over the course of a prolonged run. flexible textile sensors have been previously studied for human motion monitoring [ , , ] . the wearable system used in this study has been previously validated for lower body kinematic monitoring in running, and sensor positions on the hip were optimized [ ] . in contrast to other previous studies investigating fatigue prediction [ , ] , we have attempted to predict the rating of perceived exertion discretely and continuously instead of merely detecting a binary state of fatigue or no fatigue. using a random forest machine learning algorithm, we were able to successfully predict the rpe score of each participant throughout a prolonged run ranging from to minutes. a machine learning approach to estimate the level of fatigue during running has been demonstrated previously by khan et al. using semg and blood lactate analysis [ ] . however, this study only segmented fatigue into three classes (aerobic, anaerobic, and recovery phases based on blood lactate levels) whereas we were able to estimate fatigue accurately over a range of rpe from to . the advantage of our method is that fatigue can be more discretely predicted, which allows for graded monitoring. this method has the potential to be used in biofeedback to report the level of fatigue in real-time, lending itself to performance and injury risk applications. our method using strain sensors showed a strong correlation between lower extremity kinematics and rpe level for all participants (r > . ). the importance of the second level regression is in mapping the rough estimation of the first level regressor (figure ) to the rpe level. the first level regressor interpolates between the existing rpe levels and therefore its results are scattered around true rpe levels (e.g., knee ankle in this study we investigated the ability of flexible textile wearable sensors to monitor and predict the rating of perceived exertion over the course of a prolonged run. flexible textile sensors have been previously studied for human motion monitoring [ , , ] . the wearable system used in this study has been previously validated for lower body kinematic monitoring in running, and sensor positions on the hip were optimized [ ] . in contrast to other previous studies investigating fatigue prediction [ , ] , we have attempted to predict the rating of perceived exertion discretely and continuously instead of merely detecting a binary state of fatigue or no fatigue. using a random forest machine learning algorithm, we were able to successfully predict the rpe score of each participant throughout a prolonged run ranging from to minutes. a machine learning approach to estimate the level of fatigue during running has been demonstrated previously by khan et al. using semg and blood lactate analysis [ ] . however, this study only segmented fatigue into three classes (aerobic, anaerobic, and recovery phases based on blood lactate levels) whereas we were able to estimate fatigue accurately over a range of rpe from to . the advantage of our method is that fatigue can be more discretely predicted, which allows for graded monitoring. this method has the potential to be used in biofeedback to report the level of fatigue in real-time, lending itself to performance and injury risk applications. our method using strain sensors showed a strong correlation between lower extremity kinematics and rpe level for all participants (r > . ). the importance of the second level regression is in mapping the rough estimation of the first level regressor (figure ) to the rpe level. the first level regressor interpolates between the existing rpe levels and therefore its results are scattered around true rpe levels (e.g., figure , participant ). however, the second level regressor learns how to map the interpolated values to the exact rpe levels. the contribution of different sensors to the final prediction values was highly participant-specific, indicating the individualized nature of fatigue. when comparing the contribution of different joint kinematics to the overall estimation of rpe, we found that we were able to obtain an r of . using only the hip sensors which was one percent less than when using all sensors. conversely, we observed a significant reduction in the coefficient of determination while using only knee or ankle sensors. previous studies have reported large increases in ankle frontal plane motion after an exhaustive run [ , ] , but as our sensor configuration was primarily oriented to detect changes in ankle sagittal plane motion, the ability of the ankle sensor to detect these large changes was limited. furthermore, peak knee flexion decreases during stance but increases during swing, resulting in minimal changes to overall sagittal plane knee excursion through the gait cycle [ ] . in contrast, while peak hip flexion increases (~ %) during an exhaustive run, hip extension decreases by a much larger degree (~ %), [ ] which may explain why the hip sensors in our study accounted for the majority of the information regarding level of fatigue. given the importance of the hip sensors to the overall detection of fatigue, it is possible that a garment using only hip sensors (i.e., tight-fitting shorts) would maintain the strong level of fatigue prediction, while potentially being more attractive to the user (e.g., in warmer weather). flexible textile strain sensors provide a convenient approach to measuring biomechanical changes resulting from fatigue. gold standard methods, including force plate analysis or optical motion capture systems, are challenging for running applications because of the restriction of data collection to lab settings [ ] . other methods that allow for collection outside of the lab, including semg, can be plagued with poor signal quality from the difficulty of maintaining appropriate contact with the skin during prolonged vigorous movements. monitoring kinematics to estimate fatigue has been extended to other activities outside of running. karg et al. [ ] used optical motion capture to monitor kinematics and proposed using a hidden markov-based approach to continuously monitor fatigue while performing a squat. the authors were able to obtain an rmse value of . and r of . with this method. our results are comparable with their findings but have the advantage of being able to monitor participants "in field". strohrmann et al. [ ] showed that there is an average correlation coefficient of . between features extracted from imus mounted on the lower and upper body. our findings indicate that an array of four strain sensors mounted only on the hip has the potential to achieve even better results (r = . ). these sensors can be sewn into running garments (such as tights or shorts) that are more likely to be worn by a runner. one major limitation of estimating fatigue level is the variability of kinematic changes between individuals [ , ] . for this reason, most of the previous studies have proposed intra-participant models [ , , ] . however, using a motor learning approach may overcome this limitation and we aim to investigate this in future studies with larger and more diverse samples. another perceived limitation of this study is the use of a self-reported measure of fatigue (borg rpe scale) as opposed to a physiological measure, such as blood lactate level. however, rpe has been strongly correlated with blood lactate level and is less invasive [ , ] . the borg rpe scale has been used frequently in previous running studies as a self-reported measure of fatigue [ ] [ ] [ ] , ] . variations on this scale have also been proposed to be better estimates of training load than other objective measures such as blood lactate concentration and heart rate [ , , ] . this is thought to be due to the subjective (emotional) components of fatigue which are believed to be intricately involved with the peripheral components (e.g., glycogen depletion) in the development of the sensation of fatigue [ , ] . we also defined "perceived effort" to the participants prior to the prolonged run and provided descriptive anchors for the number ratings to minimize the subjectivity of rpe [ ] . this was the first study to propose and evaluate a method using resistance-based flexible textile strain sensors to monitor and predict fatigue in running. we successfully predicted the rating of perceived exertion in all participants during a prolonged run using a pair of previously validated instrumented running tights and a random forest machine learning algorithm. these findings have the potential to offer an objective measurement of fatigue that is non-invasive and based on kinematic changes during a prolonged run. our results may lead to the development of real-time biofeedback applications that have the potential to improve performance and prevent injury among runners. future studies should investigate the potential of using flexible textile wearable sensors for training general models and improving inter-participant results. researchers should investigate the potential is running associated with a lower risk of all-cause, cardiovascular and cancer mortality, and is the more the better? a systematic review and meta-analysis health benefits of different sport disciplines for adults: systematic review of observational and intervention studies with meta-analysis incidence and determinants of lower 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forests classification and regression by randomforest a novel method for classification of running fatigue using change-point segmentation gait retraining: out of the lab and onto the streets with the benefit of wearables classifying lower extremity muscle fatigue during walking using machine learning and inertial sensors chapter the cardinal exercise stopper: muscle fatigue, muscle pain or perception of effort? fatigue is a brain-derived emotion that regulates the exercise behavior to ensure the protection of whole body homeostasis rating of perceived effort: methodological concerns and future directions this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license key: cord- - blsjicu authors: missel, malene; bernild, camilla; dagyaran, ilkay; christensen, signe westh; berg, selina kikkenborg title: a stoic and altruistic orientation towards their work: a qualitative study of healthcare professionals’ experiences of awaiting a covid- test result date: - - journal: bmc health serv res doi: . /s - - - sha: doc_id: cord_uid: blsjicu background: extensive measures to reduce person-to-person transmission of covid- are required to control the current outbreak. special attention is directed at healthcare professionals as reducing the risk of infection in healthcare is essential. the purpose of this study was to explore healthcare professionals’ experiences of awaiting a test result for a potential covid- infection. methods: qualitative interviews with healthcare professionals were performed, underpinned by a phenomenological hermeneutical analytical framework. results: the participating healthcare professionals’ experiences of awaiting a covid- test result were found to be associated with a stoic and altruistic orientation towards their work. these healthcare professionals presented a strong professional identity overriding most concerns about their own health. the result of the coronavirus test was a decisive parameter for whether healthcare professionals could return to work. the healthcare professionals were aware that their family and friends were having a hard time knowing that the covid- infection risk was part of their jobs. this concern did not, however, cause the healthcare professionals to falter in their belief that they were doing the right thing by focusing on their core area. the threat to own health ran through the minds of the healthcare professionals occasionally, which makes access to testing particularly important. conclusion: the participating healthcare professionals had a strong professional identity. however, a discrepancy between an altruistic role as a healthcare professional and the expectations that come from the community was illuminated. a mental health coronavirus hotline for healthcare professionals is suggested. the covid- pandemic puts healthcare professionals (hcp) under pressure both physical and psychological [ ] . the challenges include increased workload created by the outbreak but also fears of contagion for themselves, their families and patients. particularly psychological health outcomes and distress are highlighted in current research regarding the initial stage of the covid- outbreak in terms of anxiety, depression and post-traumatic symptoms [ ] [ ] [ ] [ ] [ ] . across these studies hcps working during the epidemic report frequent concerns regarding their own health. based on our knowledge, little information is however available regarding the impact on hcps awaiting a test result for potential covid- infection or interventions for supporting them during this waiting time. therefore, this study aim to shed light on hcps' experiences of awaiting a test result for a potential covid- infection through individual interviews. this qualitative investigation will thus highlight what is at stake for hcps while in quarantine and awaiting a response as to whether they are infected with the coronavirus. the study offers an in-depth understanding of the meaning of the waiting for the test result for covid- infection from the hcps' perspective and should be of interest to a broad readership and add knowledge to the growing covid- evidence base and in developing supportive inetrventions targeted hcps in such a pandemic. while hcps, e.g. nurses, physisians, porters and healthcare workers, are caring for some of the most vulnerable groups of people both in hospital but also in primary care, they are currently also facing an unprecedented disease caused by the outbreak of a previously unknown virus [ ] . this new coronavirus that can cause covid- disease [ ] puts hcps in a position where they must avoid exposing themselves to infection but also avoid transmitting the infection to the vulnerable patients and citizens to whom they have a caring responsibility. because an infected hcp is a potential vehicle for virus dissemination, research suggests that reducing the risk of infection amongst hcps is essential [ ] . spread of virus has been reported during the ebola outbreak resulting in a compromised healthcare system [ ] as well as during the severe acute respiratory syndrome (sars) [ ] and the middle east respiratory syndrome (mers) epidemics [ ] . experiences from these previous outbreaks highlight fear among hcps in transmitting the disease and the importance of screening for the virus. on th january , the world health organization declared the chinese outbreak of covid- to be a public health emergency of international concern. the emergency committee stated that the spread of covid- may, among other preventive efforts, be interrupted by early detection and isolation [ , ] . general hygiene precautions are crucial in order to minimize the risk of contamination [ ] . hcps have always played an important role in infection prevention, infection control, isolation, containment and public health, which for nurses initially was advocated for by florence nightingale [ ] . there are studies that define the pathophysiological characteristics of covid- however, the mechanism of spread is uncertain. current knowledge is derived from similar coronaviruses, which are transmitted from human-to-human through respiratory infection [ ] . typically, respiratory viruses are most contagious when a patient is symptomatic. however, increasing evidence suggests that human-to-human transmission may be occurring during the asymptomatic incubation period of covid- [ , ] . the disease is reported to be very contagious, and measures to reduce person-to-person transmission of covid- are therefore required to control the outbreak [ ] [ ] [ ] . special attention and efforts to prevent or reduce transmission is applied in susceptible populations including hcps in order to reduce transmission to patients or other vulnerable groups of people in the community [ ] [ ] [ ] . hcps are thus among those groups of people who are being rapidly tested for coronavirus in denmark. considering the severity of infection and illness [ ] , the test result might be of great importance for the healthcare system but also for the individual hcp. a sudden decrease in the number of hcps because of quarantining or isolation due to covid- infection would potentially overload the healthcare system and the capacity to treat either patients with coronavirus or patients with other serious conditions would be challenged [ ] . for the individual hcp, it might furthermore be a threat to their own health. as far as we are aware, no research has so far focused on how hcps might perceive this test situation. therefore, the purpose of this study is to explore hcps' experiences of awaiting a test result for a potential covid- infection. such knowledge from the hcps' perspective are expected to increase the awareness of potential needed support while awaiting a crucial test result from a contagious and rare virus. furthermore, the study will help hospital managers to establish strategies to ensure the best possible working conditions for hcps during the pandemic. this study used a phenomenological hermeneutical methodology inspired by ricoeur's narrative philosophy [ ] . in this study phenomenology was apllied as an epistemological stance for exploring first-person accounts of what it is like to wait for a test result for potential covid- infection. pre-reflexive experiences from the participant's lifeworld is the starting point, while hermeneutics was focused on interpreting the surplus meaning contained in this lifeworld. as human beings we leave traces when we express ourselves, and these traces are formed by the meanings and traditions to which we belong. often, it is impossible to directly understand individual's experiences because the sense in the traces is hidden. therefore, reflection on an individual's lived experiences takes place via the narratives expressed by the individuals [ , ] . the threefold mimesis is central in ricoeur's narrative philosophy and can be seen as an epistemological approach for understanding the participants' lived experiences [ ] , which, in this study, has inspired the research process as a three-fold process [ ] : mimesis i (prefiguration): the life lived before it is formulated as spoken or written narrative (data collection); mimesis ii (configuration): the language stage, formulating a narrative (from speech to text); and mimesis iii (refiguration): the comprehension stage, when the text is interpreted (analysis and interpretation) [ ] [ ] [ ] . participants in this study were recruited from a population of hcps who had been tested for coronavirus but who did not necessarily care for covid- patients. if they had symptoms of covid- infection, hcps in denmark were offered testing for the virus. we used a convenience sampling strategy [ ] by encouraging tested hcps to approach the research team by e-mail if they were willing to attend an interview. the interviews were conducted by telephone based on ethical accountability for not contributing to the spread of the virus and they were scheduled in the gap between test and its result. the result of the test was during the study period given to a tested person within h. the society of denmark was on lockdown due to the threat of coronavirus on march th . coronavirus was in this period still relatively new in denmark, and - patients were hospitalized and patients died due to covid- during week three of the epidemic. fifteen hcps agreed to participate in the study and were interviewed in march and april . thereafter data saturation was achieved, making further interviewing unnecessary [ ] . we included hcps with different professional backgrounds and different responsibilities from both primary care and hospitals. the characteristics of the participants are shown in table . data were collected through individual interviews. human events are characterized by unreflecting preunderstanding, which ricoeur calls prefiguration (mimesis ) [ , ] . with the aim of gathering the participants' indepth narrative accounts of their experiences of awaiting a covid- test results, open questions were used. each interview began with a broad opening question, such as; "could you please tell me what led you to being tested for a potential covid- infection and your experiences while awaiting the test result?" table lists the interview questions. the interviews lastet on average min (range - min). the interviews were separately conducted by three experienced qualitative researchers who all had a professional background as registret nurses, and interviews were audio-recorded and transcribed into pages. the participants' stories were thus transcribed into a textual configuration of their unarticulated experiences (from prefiguration to configuration) [ , ] . according to ricoeur, people's narratives contain surplus meaning and hermeneutics is concerned with interpreting this surplus meaning (from configuration to refiguration). the study was undertaken in accordance with the guidelines of the danish ethical research committee and was approved by the danish data protection agency (p- - ). the investigation conforms with the principles outlined in the declaration of helsinki [ ] . the participants received written information about the purpose of the study and their right to withdraw at any time. written informed consent was obtained from each of the participants before the interview. data were anonymized by means of identification codes. the participants were informed that interview data would be treated confidentially. according to ricoeur, interpretation is the central methodology in phenomenological research. interpretation involves a process consisting of naive interpretation, structural analysis, and comprehensive understanding [ ] . naive interpretation is superficial interpretation, whereby the narratives are read and re-read to see what the texts mean to the researchers, giving an overall view of the narratives. structural analysis deals with patterns in the text that can explain what it is saying. explaining what the text expresses means moving from what the text says to what it is talking about. during the structural process, we analyzed and structured the narratives based on units of meaning, extracting meaning or themes that recurred in the narratives. the units of meaning were condensed such that the essential meaning was expressed. these units of meaning were then further condensed and gathered into themes [ , ] . the comprehensive understanding continues with a discussion of the themes that were identified in the structural analysis, the purpose being to reach a new understanding of the possible dimensions of the participants' experiences while awaiting a covid- test result. the deeper interpretation of the narratives is a process of understanding in which theoretical perspectives are drawn on to help clarify and comprehend phenomena in the participants' experiences [ , ] . see fig. . throughout the study methodological rigor was attained by using the qualitative concepts of relevance, validity, and reflexivity, as described by malterud [ ] . this study is one of only a few qualitative studies exploring the lived experiences of hcps during the covid- pandemic and to our knowledge this is the first qualitative study exploring hcps' experiences of awaiting a test result for a potential covid- infection. the qualitative interview method was selected in order to gain insight into these individuals' perspectives in order to understand the meaning of the investigated phenomena, i.e. the transition from experience to meaning [ ] . the relevance of the study and the chosen methodology thus seems appropriate. several strategies were employed to demonstrate internal validity, including collecting indepth data, prolonged involvement with the data and use of the participants' own words to formulate and illustrate themes. the participants are quoted in order to ensure transparency and substantiate the findings of the study. ricoeur's steps in the analytical process are clearly set out and have been stringently followed. the process from prefiguration through configuration to refiguration reflects the shift from lived life to narrative accounts of lived life to the final interpretation, which provides an insight into the individual hcps' concrete experiences and into universal phenomena of life for hcps awaiting a test result. thus other researchers are able to judge and validate the extracted themes. reflexivity was ensured by discussions between the authors, both during the data collection phase and in the analysis. the fact that all interviewers were registered nurses meant that a certain agreement but also equality between participant and interviewer was present. this meant that the conversation was relatively easy and straightforward. in order, however, to prevent blind spots in relation to the research purpose, the interviewers were particularly aware of their role as researchers and qualitative interviewers and tried to bridle preunderstandings from their background as hcps and adapting a curious stance. the comprehensive understanding illuminated the meaning of the participants' experiences of awaiting a covid- test result as a stoic and altruistic orientation towards their work. these hcps presented a strong professional identity overriding most concerns about their own health. the result of the coronavirus test was a decisive parameter for whether healthcare professionals could return to work. experiences related to the test situation as well as the strong sense of professional identity will be described in more detail in the following. what led the participants to the test for coronavirus were their experiences of mild to moderate symptoms, which aroused suspicion of possible infection. they described the importance of protecting patients, vulnerable citizens and colleagues from the risk of infection and therefore stayed away from work until they were certain that they were not contributing to the spread of the virus. this distance from work, however, had an impact on participants who described a dilemma in terms of both feeling responsible and hypochondriac at the same time. as hcps they already knew the usual workload and therefore described feelings of failing colleagues by not taking part in the work, "we are busy in healthcare, so if there is one who is sick, then the others just have to run faster" (participant k). thus, the test result was extremely important in terms of whether one could return to work and help one's colleagues. the participants, furthermore, talked of particular responsibilities in being prepared to care for and treat patients with covid- . they watched what is going on in the rest of the world in other healthcare settings where the epidemic of covid- exceeded the healthcare systems' resources. they were very concerned about their colleagues in other countries but at the same time had an altruistic view that they themselves must also be prepared. in this context, coronavirus tests are also particularly important for the participating hcps. they did, however, describe an ambivalence around the test response; if you are tested positive, then hopefully you will form some kind of immunity and thus be able to go to work after a period of quarantine without being infected again. if, on the other hand, you are tested negative, you can return to your job immediately, "i hope i don't have corona, but on the other hand, then you have had it …" (participant c). participants describe concerns and fears that many hcps will be infected at the same time, and that there will be no one to take care of the ill patients or vulnerable citizens. therefore, it was necessary to have the hcps tested so that an overview of the workforce can be maintained as hcps cannot easily be replaced. the way to being tested could, however, be quite obscure for some of the participants. for participating hcps working in the hospital, access to testing is easy and straightforward. they noticed symptoms, they discussed it with their boss, and they got tested. however, working in primary care posed major problems in figuring out access to being tested. those hcps narrated experiences of not being taken seriously, which produced a kind of powerlessness, "all of us who work in healthcare, we are there to make a difference, but you just feel that we sometimes are banging our head against the wall [experiencing lack of understanding] … it gives a sense of powerlessness" (participant e). they furthermore described frustrations of wasting precious time waiting to get to the test; time that could have been spent usefully in continuing their work. the particular commitment to caring for vulnerable and ill people was evident when participating hcps were just waiting to be tested. even though being tested for coronavirus when experiencing symptoms was strongly preferred by the participants in this study, the test situation, however, reminded and confronted them with the seriousness of the pandemic. they described their experiences of coming into the interimistic tents outside the hospital and meeting with test staff in protective equipment. the participants, being hcps, were prepared for this scenario but are anyway confronted with feelings of being part of a surreal experience or a science fiction movie but also that this new virus was real, "it is a peculiar experience to meet another person who is covered from head to toe. you suddenly feel very dangerous" (participant f). they also, however, told of a professional set-up and that being tested provided certainty, tranquility and direction. the participating hcps in this study presented a strong sense of professional identity and were highly oriented towards their work. they talked about how they were preparing for battle against the coronavirus despite the risk of being infected themselves. the frontline hcps with the critical task of caring for covid- patients told how for a long time and with no evidence of even having the disease, they had isolated themselves at home, "i already decided days ago that we should stop sleeping in the same room and avoid physical contact completely. i have also written on my wife's and my behalf to family and friends that we will not be able to see anybody for a while" (participant b). they were tremendously aware of their specific role and duty and that nobody could stand-in for them and explained it as just being a part of their job and with a fatalistic attitude. these participants expressed a paramount need to know if they were contagious. common to the participants was that, by virtue of their profession, they had important professional knowledge about drop infections, hygiene, symptoms and pathways of infection, all of which gave them a readiness to act. they narrated how they were extremely aware of not transmitting the infection to others, as well as how to take distance and hygiene measures when they noticed symptoms of potential covid- . these measures seemed to be integrated as an almost natural act in the participants' lives with them not questioning the necessity of doing so, "i've locked myself inside a room now and told the others in the family to stay away. and if i'm going to the toilet ..., our apartment is quite small ... but then i just shout that now i go to the toilet. and then i have hand sanitizer and cleansers and wipe it all off afterwards" (participant c). the situation thus appears to have been tackled with stoic calm by the participants as they awaited answers as to whether their possible symptoms are related to covid- . despite their professional knowledge, participants also told of chaotic and conflicting information from the healthcare system expressed as an information flow that had become incomprehensible and overwhelming. this resulted in uncertainty and difficulty in keeping up with guidelines. the participants' social network was marked by the possible threat of covid- from the hcps who were just doing their job in healthcare. the participating hcps were highly aware that their family and friends were having a hard time knowing that the covid- infection risk was a necessary condition of their job, while they at the same time are forced to keep a distance. this concern did not, however, cause participants to falter in their belief that they were doing the right thing by focusing on their core area, which was caring for ill and vulnerable people. the threat to their own health ran though the minds of the participants once in a while, "that people who take care of their work and do what they can to make others survive can end up getting infected with covid- themselves, i think that's a little hard, but that's just how it is" (participant g). the participating hcps express a need to share such thoughts with somebody and ask for some kind of follow-up or a hcp corona hotline, e.g. after being tested for the virus, "when you are nervous and scared, it would be helpful if you could go to one specific place where knowledge and expertise about corona was gathered -a mental health corona hotline" (participant d). being oriented towards their job was described as a natural part of the participating hcps approach to life. they had a strong passion for and pride in their work and in this epidemic context showed solidarity across professional boundaries. they did question if they may be too uncritical but explained it with the fact that they are in a time when it is necessary to do as one is told. the participants, however, described how they have experienced the community tribute e.g. public applause for them as on the edge of hypocrisy. they rejected more applause from society and express how genuine societal recognition would be more resources in hospitals to solve problems and to give the hcps a tolerable everyday life and a decent salary. awaiting a covid- test result for the participating hcps was associated with a stoic and altruistic orientation towards their work in which the result of the test was crucial. this study illuminated how hcp prepare and get ready for battle against covid- in a devoted and solidarity-based way. this war metaphor as a response to the pandemic might illuminate the hcps' stoic and altruistic work identity. seeing the coronavirus as an enemy that should be defeated and as a part of one's job require hcps who approach their work with a stoic calm and an altruistic attitude. a similar commitment to supporting their health system and communities has been reported during the ebola epidemic [ ] . the participants in our study presented a strong professional identity and their attention was directed to caring and protecting patients and vulnerable citizens while also preventing the spread of infection among colleagues. being stoic in their approach to work does not mean that hcp are cold and distant, it is rather an attitude of remaining calm and carrying on and may also involve having a certain degree of self-control and maintaining a sense of conscious self-awareness [ ] . the altruistic attitude or behavior of the participants was characterized by the fact that the individual sought to promote the well-being of others without thought for their own interests and needs. according to hume, altruism is a character trait of humans that normally extends to strangers only in a weakened form and it is rare to meet with one in whom the affections of altruism do not over-balance the selfish [ ] . altruism was, however, a strong moral part of the participants' professional identity which seems to be based on the inner logic of the hcp discipline. understanding of the roles altruism might play in the social and medical response to an epidemic and the stories about the nature of hcps' moral obligations has been discussed and implies the willingness to take personal risks in the line of duty [ ] . a professional identity can be defined as a social identity that relates to people's understanding and presentation of themselves as professionals [ ] . it is seen as the identity a person has developed through learning and practicing a given profession and thus can fulfill a particular employment function designed and integrated into a given work and professional culture. according to goffman, identities are not created individually, but rather the individual gains his or her professional identity through the attribution of certain characteristics that have the character of normative expectations [ ] . in addition to performing the expected functions associated with a specific field, the individual thus supports and supplements his or her position by simultaneously playing the normatively expected role associated with that group [ ] . to follow goffman [ ] , the stoic and altruistic orientation towards their work presented by hcp in the present study might also point to these hcp acting in accordance with a specific role within a given social context, such as healthcare. society's normative expectations of hcp may influence their perception of their own professional identity. our study, however, illuminates a discrepancy between an altruistic role as hcps and the normative expectations that come from the community that pays tribute to them, and then an experience of working conditions and salaries that do not indicate recognition. altruism has been reported to be declining in the face of economic and pragmatic motivation [ ] which might threaten healthcare practice during an epidemic such as covid- . another threat to our study participants' stoic and altruistic orientation towards their work was also experiences of receiving chaotic, conflicting and an overwhelming information flow resulting in difficulties in keeping up with best practice guidelines. research from the a/h n influenza pandemic have demonstrated how perceived sufficiency of information was associated with reduced degree of worry and how hcps less frequently felt unprotected [ , ] . these points highlight that hospital managers should try to provide and direct information for hcps according to what is needed during the different and specific phases of a pandemic based on the affected hcps' perspectives in order to offer favourable working conditions in times of extreme distress. being tested for coronavirus for the hcps in our study was significant in order to maintain their professional identity and continue working. they did, however, also describe experiences of uncertainty and fear for own health and expressed a need to share such thoughts with somebody. a threat to the mental health of hcps during epidemics has been reported [ , , ] , and interventions to promote mental well-being in hcps exposed to covid- are suggested to be immediately implemented [ ] . a hotline for patients during the current covid- outbreak has been established in some places, e.g. in new york where citizens are guided to assess their own symptoms at home and can discuss any psychological impact from the disease [ ] . similar initiatives directed at hcps are needed. recomandations from a recent systematic review also suggest to establish a forum for medical personnel to voice their concerns as well as a psychological assistance hotline comprised of volunteers who have received relevant psychological training to be able to provide telephonic guidance to personnel to help effectively tackle mental health problems [ ] . telephone interviews in this study were unavoidable due to the risk of virus transmission between participants and interviewers. such interviews do, however, have some disadvantages. they are more impersonal in that it is not possible to have eye contact, and as an interviewer, it is difficult to show that you are interested and included in what is being said. in addition, breaks are generally less acceptable [ ] . despite this, we found that participants were willing to participate in the study and appreciated talking about their experiences. the sample included in this study consisted of more female hcps (n = ) and most were nurses (n = ) which might be an uneven distribution of participants. women, however dominate the nursing profession, and nurses are the largest professional group in healthcare [ , ] and the sample thus represents the general healthcare workforce. what is worth noting is that this study was conducted during the first phase of the pandemic. this means that the stoic and altruistic orientation as well as the war metaphor that we have found and described may change over time as the pandemic progresses and hpcs may experience burnout. the perspectives of hcps awaiting a test result for coronavirus provide an important contribution to the growing body of literature about covid- . these hcps had a strong professional identity with their attention directed towards caring and protecting patients and vulnerable citizens while also preventing the spread of infection among colleagues. a discrepancy between an altruistic role as a hcp and the normative expectations that come from the community was also illuminated. the clinical implications of this study is thus, that as a stoic and altruistic attitude dominated hcps' identity, access to testing for covid- for these professionals is crucial. furthermore, a mental health corona hotline for hcps should be established. abbreviations hcp: healthcare professionals mental health care for medical staff and affiliated healthcare workers during the covid- pandemic timely mental health care for the novel coronavirus outbreak is urgently needed prevalence of depression, anxiety, and insomnia among healthcare workers during the covid- pandemic: a systematic review and meta-analysis the psychological impact of epidemic and pandemic outbreaks on healthcare workers: rapid review of the evidence the psychosocial impact of flu influenza pandemics on healthcare workers and lessons 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( -ncov) infected pneumonia (standard version) retningslinjer for håndtering af covid- i sundhedsvaesenet (guidelines for managing covid- i the healthcare system). copenhagen; severe acute respiratory syndrome coronavirus (sars-cov- ) and coronavirus disease- (covid- ): the epidemic and the challenges ricoeur's narrative philosophy: a source of inspiration in critical hermeneutic health research en hermeneutisk brobygger. tekster af paul ricoeur nursing research: generating and assessing evidence for nursing practice declaration of helsinki discource and the surplus of meaning qualitative methods in medical research we and the nurses are now working with one voice": how community leaders and health committee members describe their role in sierra leone's ebola response the therapy of desire. in: theory and practice in hellenistic ethics altruism in hume's treatise diminishing returns? risk and the duty to care in the sars epidemic bankmedarbejderen-splittet mellem varnaes og scrooge (bank employees -split between varnaes and scrooge) two studies in the sociology of interaction. united states: martino fine books professional nursing values: a concept analysis general hospital staff worries, perceived sufficiency of information and associated psychological distress during the a/h n influenza pandemic psychological impact of the pandemic (h n ) on general hospital workers in kobe health professionals facing the coronavirus disease (covid- ) pandemic: what are the mental health risks? a phone call away: new york's hotline and public health in the rapidly changing covid- pandemic factors affecting the psychological well-being of health care workers during an epidemic: a thematic review sundhedsvaesen og sundhedspolitik (healthcare and healthcare politics) closing the gap in indigenous health inequity -is it making a difference? publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the research team wishes to thank all those people who collaborated and participated in this study by sharing their experiences. without them, this study would not have been possible. we also thank anne alexandrine Øhlers, camilla rotvig jensen, christina jensen, mette skriver and miriam bianca besser biyai for their help in relation with the transcription of the interviews. all authors conceived and contributed to the design and conduct of the study. skb, cb and mm conducted the collection of data material and led the analysis together with swc and id. all authors were involved in the analysis and the writing of the manuscript. all authors contributed to the preparation of this manuscript and read and approved the manuscript. this work was supported by the novo nordisk foundation (grant number nnf sa ), and centre for cardiac, vascular, pulmonary and infectious diseases, rigshospitalet, copenhagen university hospital, denmark.availability of data and materials all authors have full control of all primary raw data (interview transcripts) and allow the journal to review our data if requested. all raw data are written in danish. data are stored in a locked file cabinet in a locked room at the copenhagen university hospital as requested by the danish data protection agency. the data material used in this study are available from the corresponding author on reasonale request which will not conflict with the anonymity and confidentiality of the data.ethics approval and consent to participate registration and permission was received from the authorities in the danish data protection agency under the capital region of denmark: (p- - ) and the study were undertaken in accordance with the guidelines of the danish ethics research committee. the participants received verbal and written information about the study prior to the study. written consent was obtained from the participants. given the qualitative nature of the study, the local ethics committee in the capital region of denmark ruled that no formal ethical approval was required in this particular case. not applicable. the authors have no conflicts of competing interest to declare.author details clinical nurse specialist at the department of cardiothoracic surgery, centre for cardiac, vascular, pulmonary and infectious diseases, rigshospitalet, key: cord- -kweh doo authors: williams, simon n; armitage, christopher j; tampe, tova; dienes, kimberly title: public perceptions and experiences of social distancing and social isolation during the covid- pandemic: a uk-based focus group study date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: kweh doo objective: explore the perceptions and experiences of the uk public of social distancing and social isolation measures related to the covid- pandemic. design: qualitative study comprising five focus groups carried out online during the early stages of the uk's social distancing and isolation measures ( - days post lockdown). setting: online video-conferencing participants: participants, all uk residents aged years and older, representing a range of gender, ethnic, age and occupational backgrounds. results: the social distancing and isolation associated with covid- policy has had having substantial negative impacts on the mental health and wellbeing of the uk public within a short time of policy implementation. it has disproportionately negatively affected those in low-paid or precarious employment. practical social and economic losses - the loss of (in-person) social interaction, loss of income and loss of structure and routine - led to psychological and emotional 'losses' - the loss of motivation, loss of meaning, and loss of self-worth. participants reported high adherence to distancing and isolation guidelines but reported seeing or hearing of non-adherence in others. a central concern for participants was the uncertainty duration of the measures, and their ability to cope longer-term. some participants felt they would have lingering concerns over social contact while others were eager to return to high levels of social activity. conclusions: a rapid response is necessary in terms of public health programming to mitigate the mental health impacts of covid- social distancing and isolation. initial high levels of support for, and adherence to, social distancing and isolation is likely to wane over time, particularly where end dates are uncertain. social distancing and isolation 'exit strategies' must account for the fact that, although some individuals will voluntarily or habitually continue to socially distance, others will seek high levels of social engagement as soon as possible. habitually continue to socially distance, others will seek high levels of social engagement as soon as possible. • adherence to non-pharmaceutical interventions during pandemics is lower where people have low trust in government and where people perceive themselves at relatively low risk from the disease • there is a need for evidence on public perceptions and experiences of the psychological and social public experiences of covid- related social distancing and isolation, and its relation to adherence. • people lack trust in government and perceive themselves at low personal risk,but closely adhere to social distancing and isolation measures motivated by social conscience, and are critical of non-adherence in others. • population-wide social distancing and isolation can have significant negative social and psychological impacts within a short time of policy implementation. • key concerns during social distancing and isolation are uncertainty of duration and ability to cope longer-term. • at the end of pandemic 'lockdowns', some individuals will likely voluntarily or habitually continue to socially distance, while others will likely seek high levels of social engagement as soon as possible. . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . the current coronavirus pandemic presents the greatest threat to public health in living memory and promises to be the deadliest pandemic since - . [ ] [ ] pandemics are challenging for clinical and public health agencies and policymakers because of the scientific and medical uncertainty that accompanies novel viruses like covid- . [ ] [ ] since covid- is a new virus, pharmaceutical interventions like vaccines are not presently available. public health policy is therefore exclusively reliant on non-pharmaceutical interventions (npis). the key npis being used in relation to the covid- pandemic in the uk and globally (in addition to personal hygiene advisories (e.g. emphasising regular and thorough handwashing)) are social distancing (e.g. prohibiting public gatherings, closing schools and other non-essential services, and keeping a distance of > metres apart from others) and social isolation (e.g. remaining indoors except for one brief outing for per day for physical activity or 'essential supplies'). [ ] due to the unprecedented scale and severity of the social distancing and social isolation measures being implemented in response to covid- , the social and psychological impacts on the public are also likely to be unprecedented in scale and severity. a recent rapid review of the psychological impact of quarantine found that longer quarantine duration, infection fears, frustration and boredom, inadequate supplies, inadequate information, financial loss and stigma were among the major stressors. [ ] another systematic review of the literature on npis in relation to pandemic influenza and sars found that people actively evaluate npis in terms of criteria such as perceived necessity, efficacy, acceptability and feasibility. [ ] public views on social distancing and social isolation are ambivalent in some contexts because of their perceived adverse social and economic impacts and their ability to attract stigma, particularly amongst those required to self-isolate. [ ] existing research on social distancing and isolation highlights a number of . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint challenges for public health policymakers, including a lack of trust in government; [ ] concerns over strains in family resources; [ ] gaps and confusions in some areas of pandemic information communication; [ ] and low adherence to voluntary social isolation and relatively low adherence to non-attendance at public gatherings. [ ] although there is existing research from past pandemics on its likely effects, [ ] and new quantitative research is starting to emerge, [ ] there is no published qualitative evidence on public perceptions and experiences of the psychological and social public experiences of covid- related social distancing and social isolation, and its relation to adherence -a gap that the present study addresses. this study aimed to explore four main questions: ( ) what are the social and psychological impacts of social distancing and isolation experienced by the uk public during the covid- pandemic? ( ) what are people's views on government communication around social distancing and isolation? ( ) what are people's current experiences of adherence in relation to social distancing and isolation? ( ) what are people's views on the future in regard to covid- social distancing and isolation. this study therefore aims to contribute to knowledge of adherence to social distancing and isolation policy to provide insight into how communication with the public on social distancing and isolation may be shaped and improved in the future. five online focus groups with participants were run between march th and april th , ( - days after lockdown commenced on the rd march ). participants were adults aged years or over currently residing in the uk. under normal circumstances, online focus groups can be a useful way of eliciting public views related to matters of health and medicine, particularly from diverse and geographically dispersed participants [ ] [ ] but were necessary due to social isolation policy. . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint purposive sampling was used to provide a diverse range of ages, genders, race/ethnicities and social backgrounds and to explore the study's research questions. [ ] [ ] potential participants were asked to complete a very brief demographic survey to provide background information and to facilitate recruitment of a diverse population (table ) . due to social distancing measures, it was necessary for all recruitment to be conducted online. researchers used a combination of social media snowball sampling, online community and volunteer advertising sites and social media advertisements (facebook ads). to ensure that online discussion was manageable, focus groups were kept to between - participants. each group met virtually via a web video-conferencing platform (zoom) for between - minutes. participants joined using both video and audio. all focus groups were organised and moderated by sw (a medical social scientist). the topic guide for the focus groups was initially developed using existing literature on public attitudes and experiences in past pandemics and was tested and refined in a pilot focus group. the main topics for the focus groups were: general views on social distancing and isolation; health impacts of social distancing and isolation; views on government covid- advice and communication; and views on compliance with, and the future impacts of, social distancing and isolation. . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint analysis data collection and analysis followed an iterative process, whereby emergent themes from early focus groups were used to add to or refine questions and prompts during subsequent focus groups. all focus groups were recorded and transcribed for coding. sw and kd analysed the transcripts and developed and applied the thematic coding framework. themes were discussed and developed with cja and tt during virtual research group meetings. to help analysis we looked to validate "sensitive moments" between groups that indicated difficult but important issues. [ ] negative case analysis was used to seek for information that did not fit emergent themes, and where this occurred, themes were modified accordingly. [ ] . following a grounded theory approach, data were organised into primary and more focused codes that provided insight into identified themes. [ , ] data collection and analysis continued until saturation occurred (that is, until no new significant themes emerged). [ ] data were analysed in nvivo (version . . , qrs). all participants felt that the social distancing and isolation polices had had significant social and psychological impacts on their lives and the central theme was loss (box ). this . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint experience of loss, which one participant likened to a process of "grieving" (participant , male, age , london), consisted of three practical social and economic losses: loss of (inperson) social interaction, loss of income, and loss of structure and routine. these in turn led to three psychological and emotional "losses": loss of motivation, loss of meaning, and loss of self-worth. first, participants spoke of a loss of social interaction. the suddenness and extensiveness of the lack of face-to-face contact had, even after only one week of lockdown, already "taken its toll on mental health" (participant , male, age , manchester), leaving participants feeling "alienated" (participant , male, age , london). a number talked about feeling depressed or anxious as a result of social distancing or isolation, an experience some likened to "a prison" (participant , female, age , london). second, a number of participants discussed how a loss of income, either through permanent loss of a job, or through temporary loss (via lost clients or customers or being furloughed), had left them feeling "quite depressed" (participant , female, age , london). third, participants expressed of a loss of structure and routine. the inability to go to work, or for some the significant re-structuring of work patterns, including balancing home working with home schooling, meant that participants felt "overwhelmed" (participant , female, age , london). participants discussed how impacts like losing their job or not being able to go to work, and not being able to socialise with friends, meant they experienced a general loss of meaning in life. one participant already felt in need of professional mental health support, less than two weeks into isolation. participants also spoke of a loss of motivation to perform basic everyday tasks, such as personal hygiene and grooming or exercising. for some, this lack of motivation had left them feeling "sluggish" (participant , male, age , london). finally, participants expressed feeling a loss of self-worth. these emotional and . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint psychological losses were particularly acute for those living in more urban, densely populated cities like london or birmingham. they were also especially evident amongst those in lowpaid or precarious occupations, who had either lost their job or income or were now relying on parental, familial or state financial support as a result of the pandemic. "i'm literally planning day-to-day as things go along. … i'm not used to having the kids every . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint single day because they are usually at school. it's difficult to work around them, i can't do anything with them, because i can't go out. i feel so scared and don't want to risk it." (participant , female, age , london) "all this talk about social distancing and things is so depressing, terrible, i mean i have even been contemplating on contacting the samaritans just to be able to try to get through all this." (participant , male, age , london) "being locked in a room trying to find something meaningful to do during the day, and i think it's had a severe impact … i hope something changes within a few weeks, so i am able to go out and live a fulfilling life" (participant , male, age , birmingham) "physically it has had a toll on people. all day you are stuck at home. you eat, you sleep, you work, its gonna have an effect on the body, there is no real drive or motivation." (participant , male, age , london) "we are feeling very down and demotivated, very low very depressed to some extent… it's become more stressful to get by and function on a daily basis." (participant , male, age , birmingham) "your self-worth goes down a bit, because you can't socialise with people and make yourself feel good about yourself." (participant , male, age , manchester) "the company i work for has closed down and i have had to apply for welfare assistance … and i've had to go and live with my parents now, and they have had to support me financially. … it's . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint been difficult, the whole mental health, the ability to function and get by, and being constantly locked in." (participant , male, age , birmingham) most participants felt that guidance on social distancing and isolation had been generally unclear, although some described how it had "become clearer" over the course of the pandemic (participant , male, age , glasgow) (box ). many participants exhibited a lack of trust either in government, who were seen to be "politicising" the pandemic (participant , male, age , north-west england), or in the media, who they felt were providing confusing information or "mixed messages" (participant , male, age , birmingham). participants felt that despite being locked at home, the constant media and social media attention on covid- made them feel "claustrophobic in both a physical and an emotional sense" (participant , male, age , london), and that "seeing others in a heightened state of anxiety makes it harder to suppress that in yourself" (participant , female, age , north west england). another common criticism was over the ambiguity of terms such as 'essential' and 'emergency' supplies and services. this ambiguity, participants argued, meant that advice was either hard to follow or implement, or that "loopholes" could be exploited (participant , female, age , south wales) (see section below on compliance, non-compliance and the future). mixed or unclear messages . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint "after reading several news publications and channels, there has been much campaign around social distancing, and with isolation you normally associate it when you have got the virus yourself, but i think over the past week there have been several mixed messages over social distancing." "now everyone has been told that they have to stay in their houses, and people are thinking well 'this can be classed as essential, and this can be classed as essential, whereas although we have been told a list of things we can do, people are finding loopholes and finding ways to get round them" (participant , female, age , south wales) "i have seen loads of people outside, and i wonder how people will enforce that [penalty fines for not social distancing], i'm wondering how can someone prove they are going for an 'emergency reason'?" (participant , male, age , manchester) all participants reported being highly adherent to government instructions on social distancing (box ). participants described how, despite the perceived lack of clarity discussed above, they had been social distancing and isolating as far as possible. participants also displayed a high degree of social consciousness, with many acknowledging that despite . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint not perceiving themselves as being at high risk, they were doing it to "save lives" and protect those most vulnerable to the disease. despite reporting their own high degree of adherence, many participants suggested that they had seen instances of non-adherence in others. observations of non-adherence were associated with three main factors. first, non-adherence was seen to be due to a lack of social conscience. participants were generally critical of what they perceived to be a minority of "inconsiderate" (participant , female, age , london) or "arrogant" (participant , male, age , south wales) individuals who were not observing instructions related, for example, to public gatherings and not keeping a distance of > metres apart from others when out for daily walks or runs. second, non-adherence was seen to be due to a lack of understanding. for example, participants argued that people who were not observing social distancing lacked knowledge over how they could help spread the disease even if they themselves were not exhibiting symptoms. third, non-adherence was seen to be due to a lack of enforcement. many participants were critical that police were choosing to enforce social distancing restrictions or were not able to (due for example to the ambiguity of terms such as "essential" as discussed in the previous section). others discussed how, despite their best efforts, supermarkets appeared to struggle to implement social distancing. high levels of support for, and adherence to social distancing and isolation . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint non-adherence due to lack of social conscience "i'm worried that people are going to take advantage of the nice weather and ruin it for people … its insane because they have shut the park, but you get some inconsiderate people like a group of lads playing football or people taking over the paths." (participant , female, age , london) "the canal path we walk along is not metres wide, but you can just about get around it if you go on the verge and they go on the verge, and most people do but not everybody does … i don't say anything because … with all the publicity that's out, if you are still choosing to do that, then me telling you not to do it is not going to make a difference, it's frustrating" (participant , female, the vast majority of people are taking it seriously and suffering to a certain extent, but there is a minority who don't necessarily understand it applies to them also. i know of people who have gone to parks or gone for a picnic, because they think 'well we don't know anyone who has any symptoms, and we've not got anything, so we can go about it in the same way'." (participant , female, age , south wales). "they say that you are not allowed to go out for non-emergency reasons, which i don't think a lot of people are observing. people are just going out whenever they want. those guidelines are in place by boris [johnson; uk prime minister] but no-one is really enforcing that. you see police on the street, but they are not really doing anything." (participant , male, age , manchester) "the supermarket they are not implementing, what's the point in having the two-metre thing outside when you can't do that inside. … i went to the supermarket and people respect it outside, . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint but as soon as you go inside there is [sic] people, they don't care, they just come right up to you and try to reach over you." (participant , female, age , london). according to participants, "the biggest problem we've got is we don't know when it's going to end" and the sense of "powerlessness" this had fostered (participant , male, age ,). despite their high level of current adherence, participants acknowledged there was a limit as to how long they and others could adhere, at least without experiencing more severe social and psychological suffering. some participants felt that they would rather be told a specific time frame, even if it was far in the future. others feared that whilst they and others could "get through" this initial phase of lockdown, going "in and out" of periods of lockdown (a scenario some knew was possible due to the potential for covid- to re-emerge in a second wave) meant that "people will really struggle mentally" (participant , female, age , south wales). some felt as though they could only take things "day-by-day" because anticipating social distancing and isolation over a period of time was "too overwhelming" (participant , male, age , north-west england). looking to the future, participants were divided as to how they felt they, and others, would act when social distancing and isolation measures were either relaxed or removed. some felt that they and others would "go back to living my life completely as normal" (participant , male, manchester) as soon as possible. these participants spoke of "being desperate to go out and go to restaurants or travel a lot" (participant , male, age , london) and generally not taking a graded approach to social reintegration. they argued that if they were "told its ok" to socially reintegrate, then this was enough for them to "not feel too anxious about going out with friends in the future" (participant , male, age , north-west england). others felt that it would take them a longer to return to pre-pandemic social . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint behaviours, and for example felt that they would continue to have "anxiety around health" (participant , female, age , north-west england), would be "cautious" about a "transition period where i stay in a bit more" (participant , male, age , manchester) and that people in general might remain "socially distant" from one another (participant , female, age , london). others argued that how they would act would likely depend on the circumstances under which social distancing and isolation measures were being relaxed or removed. specifically, this was tied to their perception of whether covid- still posed a risk to them or to society in general. they argued that, if a vaccine was available, then they would be happy to return to their pre-pandemic activity. the challenge of future uncertainty "i would rather they [the government] said tonight, 'you're gonna be stuck in your houses until september, than say, we will review in three weeks, and then say, we will review in three week, and keep doing that, i'd rather they set a date way in advance in the future because then you can get your head around it" (participant , male, age , south wales) "i've heard on the grapevine and online sources that we are in this lockdown for a few weeks or so, and then after weeks or so we kind of get released and because we are not all immune necessarily it all comes back in a wave and then we have this constant thing of being locked down and then coming out and going back in again, … and so i think it will go downhill, that's when people will struggle mentally because they've had that taste of freedom, and you don't know how long it's all going to finish." (participant , female, age , south wales) . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint perceptions of future behaviour "i'm literally thinking day-by-day, because if one was to consider three months of this, and we are only two weeks in, it's just too much, it's too overwhelming" (participant , male, age , north-west england) "people are not going to stay like this for another months. it's for a good reason i know, but it's like a prison, we know what people are suffering mentally and emotionally, we don't know what people are going through behind their door … when all this comes to an end we don't know how life is going to be. is everybody going to be socially distant? it's scary." (participant , female, age , london) although the findings discussed above represent the most common views exhibited by participants, negative case analysis did reveal some alternative accounts. for example, some participants argued that social distancing and isolation "hadn't been hard" (participant , male, age , south wales). however, these participants were all university students, and acknowledged that part of the reason it hadn't been as difficult for them was there had been no loss of income and, less loss of routine for them. a small number of participants argued that they were able to draw positives from the social distancing and isolation due to covid- . for example, some described how household quarantine had meant they could have "more time with their children" (participant , male, age , north-west england) or had brought family units together (participant , male, age , north-west england). however, those participants who explicitly discussed . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint the positives to be drawn from social distancing and isolation were all from higher socioeconomic backgrounds, and tended to live in more rural or less densely populated areas of the uk. our findings suggest that a large proportion of the uk public may be suffering from feelings of depression, anxiety, and loss as a result of covid- social distancing and isolation. some already feel in need of professional mental health support. the social and psychological impacts identified through this study centred around the various losses that people are experiencing. practical social and economic losses -the loss of (in-person) social interaction, loss of income and loss of structure and routine -led to psychological and emotional losses -the loss of motivation, loss of meaning, and loss of self-worth. findings also suggest that participants generally found information on social distancing to be ambiguous. however, there were differing views as to whether the government was at fault (insufficiently clear communication) or that the terms themselves are ambiguous and a small minority of the uk public were taking advantage of the ambiguity. it was recognized that this ambiguity may have been designed to permit greater social freedom than the more extreme social distancing and isolation measures implemented in other countries. additionally, there was universally high adherence to social distancing and isolation guidelines reported across the study sample, yet most participants had observed or heard of non-adherence in others. participants were highly critical of such instances of nonadherence, citing lack of social conscience, lack of understanding and lack of enforcement as likely causes. perhaps the greatest concern for participants was the uncertainty they faced over the duration of the social distancing and isolation measures, as well as their ability to cope longer-term. there was also uncertainty as to how they and others would act, with some . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint fearful of lingering inhibitions and anxiety over social contact and health, and others eager to return to normal levels of social activity. our findings on covid- social distancing and isolation support some of the findings from existing systematic reviews on previous pandemics related to influenza and sars. [ ] [ ] for instance, we found that frustration or anxiety over loss of social interaction or loss of income, inadequate or ambiguous information, and fears over the duration of social distancing and isolation measures were all major themes. [ ] [ ] [ ] . however, contrary to previous research which suggests that adherence with pandemic npis is lower in instances where people have low trust in government and where people perceive themselves at relatively low risk from the disease, [ ] our participants were highly adherent to social distancing and isolation measures, despite many lacking trust in government and perceiving themselves at low risk. in fact, stigma was more likely to be attributed to those who were failing to socially distance and isolate. of course, as noted above the scale and severity of the pandemic and subsequent measures are unprecedented. as such, although there is existing research on its likely effects, [ ] and although quantitative research is starting to emerge, [ ] there is to, our knowledge, no published qualitative evidence on public perceptions and experiences of the psychological and social public experiences of covid- related social distancing and isolation, and its relation to adherence -a gap this study addresses. one limitation of this study is that it is not possible to rule out that the high degree of adherence and social conscience that participants expressed was not at least partly affected by social desirability bias, which can often be encountered in focus group studies. [ ] however, . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint conducting focus groups online has been found to reduce social desirability bias (although it is worth noting that this is more so where asynchronous or text-only communication is used, and not video-conferencing as in our study). [ , ] another limitation of this study is that it did not recruit participants who are deemed at particularly high risk from covid- -related complications, for example, individuals aged and over and those living with certain chronic health conditions. [ ] because these individuals are likely to have been significantly affected by social distancing and isolation policy (being required to self-isolate for weeks), their views will be important. it is also worth noting that our recruitment material did encourage those at high risk to apply, though we received no applications from those over- . this may be partly due to the fact that those over- are a hard-to-reach group online, because they are significantly less likely to use social media or be heavy internet users, [ ] which, due to the lack of online social support and interaction, might mean they are at particularly high risk of some of the negative social and psychological impacts discussed in this paper. future research will explore at-risk groups' experiences in depth. future papers will also explore further the similarities and differences in views and experiences in the perceptions of experiences of participants living in different parts of the uk (e.g. london compared to less densely populated areas), a theme only briefly discussed here due to limitations of scope. this study suggests that the social distancing and isolation associated with covid- policy is having substantial negative impacts on the mental health and wellbeing of the uk public within a short time of policy implementation. the prevalence of covid- -related depression and anxiety, and the extent to which it will last beyond the removal or relaxation of social distancing and isolation policies remains to be seen. our ongoing research will . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint explore these social and psychological impacts longitudinally. policymakers and the public health community must discuss measures to respond to the likely wave of mental ill-health which is expected to follow, and which is tentatively suggested by our early qualitative evidence. the theme of loss and addressing public concerns around physical and emotional losses (e.g. meaning and self-worth), may inform current and future therapeutic interventions. loss of meaning and self-worth may be due in part to loss of control, and increasing a sense of control for the public should be considered in future policy, intervention, and programming. [ ] additionally, findings suggest that a rapid response is necessary in terms of public health programming to mitigate these mental health impacts. waiting until restrictions and isolation measures are relaxed or removed to provide support services could potentially have devastating impacts. government and the public health authorities should look at ways of extending mental health outreach services, especially remotely. [ ] timely attention is needed for those who are predisposed to depression and anxiety, those who may be suicidal, and those experiencing significant social, economic and personal loss. our study also suggests that although the covid- pandemic has had significant ramifications for many uk residents from diverse backgrounds, it has disproportionately negatively affected those in low-paid or precarious employment. future research and policy should therefore seek to develop measures that specifically seek to remediate the social, economic and psychological harms related to covid- as experienced by those from disadvantaged backgrounds. looking ahead to later stages in the current pandemic, or to the development of pandemic preparedness programmes for the future, a couple of lessons can be distilled, which warrant urgent attention. firstly, initial high levels of support for, and adherence to, social distancing and isolation measures are likely to wane over time, particularly where end dates are and remain uncertain. secondly, in planning the 'exit strategy' for the uk lockdown, and its possible impact on future resurgences of covid- . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint prime ministers impact of non-pharmaceutical interventions (npis) to reduce covid- mortality and healthcare demand plausible uncertainty": the negotiated indeterminacy of pandemic influenza in the uk the uk's policy conveys a false sense of scientific certainty and places too much responsibility in the hands of the public guidance on social distancing author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint the psychological impact of quarantine and how to reduce it: rapid review of the evidence public perceptions of non-pharmaceutical interventions for reducing transmission of respiratory infection: systematic review and synthesis of qualitative studies listen to the people": public deliberation about social distancing measures in a pandemic knowledge and attitudes of university students toward pandemic influenza: a cross-sectional study from turkey non-pharmaceutical interventions during an outbreak of pandemic influenza a (h n ) virus infection at a large public university knowledge and perceptions of covid- among the general public in the united states and the united kingdom: a cross-sectional online survey online focus groups as a tool to collect data from hard-to-include populations: examples from pediatric oncology a st century citizens' polis: introducing a democratic experiment in electronic citizen participation in science and technology decision-making rigor and qualitative research qualitative research: introducing focus groups author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint developing focus group research: politics, theory and practice qualitative research: theory, method and practice making sense of qualitative data. london: sage understanding communication processes in focus groups researching online populations: the use of online focus groups for social research advice for everyone: coronavirus (covid- ) diversity in older adults' use of the internet: identifying subgroups through latent class analysis facilitating health behaviour change and its maintenance: interventions based on self-determination theory. the eur health psychol a case of misalignment: the perspectives of local and national decision-makers on the implementation of psychological treatment by telephone in the improving access to psychological therapies service infection, policymakers and public health authorities need to account for the fact that, although some individuals will voluntarily or habitually continue to socially distance (graded social reintegration) others will seek immediately to re-integrate fully beyond what they are permitted to.health serv res. ; : .. cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity.is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity.is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint data sharing statement: ethical restrictions related to participant confidentiality prohibit the authors from making the data set publicly available. during the consent process, participants were explicitly guaranteed that the data would only be seen my members of the study team.for any discussions about the data set please contact the corresponding author, simon williams (s.n.william@swansea.ac.uk). committee.. cc-by-nc-nd . international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity.is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/ . / . . . doi: medrxiv preprint key: cord- -mmw s authors: hudson, janella; ungar, rachel; albright, laurie; tkatch, rifky; schaeffer, james; wicker, ellen r title: robotic pet use among community-dwelling older adults date: - - journal: j gerontol b psychol sci soc sci doi: . /geronb/gbaa sha: doc_id: cord_uid: mmw s objective: the primary purpose of this study was to explore the efficacy of robotic pets in alleviating loneliness for older adults. method: self-reported lonely individuals with aarp medicare supplement plans insured by unitedhealthcare who participated in a program with a robotic pet (n = ) were recruited to participate in semi-structured interviews. participants were asked to provide feedback about their experiences interacting with a robotic pet, their perceptions about the potential impact on loneliness, and recommendations for improving the program. interviews were audio-recorded and transcribed verbatim. participants’ responses were analyzed using qualitative content analysis. constant comparison and consensus-gaining processes were used to develop categories that later formed representative themes. results: seven themes emerged from analysis: openness to adoption of robotic pet, reactions to pet and its attributes, integration of pet in daily life, strategic utilization and forging new connections, deriving comfort and camaraderie, advice for future users, and recommendations for enhancing ownership experience. participants living alone, with fewer social connections and less active lifestyles, derived the most benefit from interacting with their pets. common responses to pets included cuddling, petting, grooming, and sleeping with them. some shared or loaned their pets, while others refused to loan their pets to interested peers. most reported showing their pets to others, which helped some facilitate communication and social connections. conclusion: robotic pets may be an effective solution for alleviating loneliness in older adults, especially among those who live alone, have fewer social connections, and live less active lifestyles. loneliness is generally understood as the discrepancy between an individual's preferred and actual level of social contact (peplau, ) . one in three u.s. adults aged and older report experiencing loneliness, with the total number expected to increase with the growing population of older adults (anderson and thayer, ) . among individuals older than years, loneliness is a subjective predictor of functional decline and death (perissinotto et al., ) and adversely influences mental and physical health outcomes, including depression, quality of life, health utilization, and mortality rates (cacioppo et al., ; luo et al., ; musich et al., ) . social isolation, while related to loneliness, objectively assesses reduced social network size and social contact. socially isolated individuals are at an increased risk for cognitive decline (bassuk et al., ) , cardiovascular disease (barth et al., ) , and mor-tality (eng et al., ; heffner et al., ; kaplan et al., ) . furthermore, social isolation in older adults is associated with reduced daily physical activities and increased sedentary behaviors (schrempft et al., ) . social isolation contributes to an additional $ . billion in medicare spending annually, which is attributed to additional skilled nursing facility spending and increased inpatient spending. flowers et al. attributed an additional $ per beneficiary per month for socially isolated individuals admitted to the hospital. this increase in spending, while not necessarily accompanied by an increase in use of inpatient care, suggested that socially isolated individuals may be sicker when hospitalized, and may lack the support to transition out of the hospital successfully as compared to socially connected individuals (flowers et al., ) . however, older adults who perceive their social connectedness more positively have better mental and physical health outcomes (cornwell and waite, ) . given that is often impractical to address limited social networks, interventions may aim to address perceived loneliness to improve older adults' wellness and psychological well-being (bartlett and arpin, ; krause-parello et al., ; schoenmakers et al., ) . pet ownership has demonstrated potential viability as a solution for ameliorating subjective loneliness, demonstrating both physical and psychological benefits for older adults who report being lonely (krause-parello, ; matchock, ; raina et al., ) . for example, pet owners surveyed in one study were % less likely than non-pet owners to report loneliness, even after controlling for age, living status, mood, and residency (stanley et al., ) . despite these benefits, however, pet ownership may pose special challenges for older adults, including restrictions related to finances, mobility, transportation, and housing (hart, ) . given these potential barriers, robotic pets, also known as social robots, offer a potentially ideal alternative to owning a live pet for older adults. a robust literature in social science and technology has examined the implications of social robot use among older adults. social robots, as defined by brezeal, are "designed to interact with people in a socio-emotional way during interpersonal interaction." (breazeal, ) several potential ethical implications related to older adults' use of social robots have been identified, among them reduced human contact, deception, and infantilization (a. sharkey and n. sharkey, ) further, an incongruence between robot developers' perceptions of ideal features and those features actually preferred by older adult users has been well documented. roboticists, who design and construct robots, often have a background in electrical or mechanical engineering. further, roboticists often develop social robots without the benefit of feedback from the intended audience. older adults are often regarded as passive users of social robotics, perhaps owing to stereotypes of older adults as lonely and fragile. however, this is seldom true, as both users and test users demonstrate active engagement with social robot models and consistently request robotic pet features capable of facilitating the user's desired interactivity (neven, ) . for example, in a recent study comparing and contrasting preferences of roboticists and older adult participants, older adults expressed a preference for interactive features (such as life-simulation and personalization) that were not perceived by roboticists as having the same importance (bradwell et al., ) . thus, social robot developers often fail to account for the diversity of abilities, perspectives, and preferences among older adult users (frennert and Östlund, ) . however, social robots have demonstrated benefit when used by older adults. social robots have been shown to reduce social isolation and increase conversational opportunities with the robot and other humans (a. sharkey and n. sharkey, ) observations of participants interacting with robotic pets in nursing home and laboratory settings have demonstrated promise for supporting the social and emotional needs of older adults (mcglynn et al., ) and have yielded benefits similar to those achieved during animal-assisted therapies, including improved cardiovascular measures (robinson et al., ) , reduction in loneliness (kanamori et al., ) , decreased agitation, and an increase in feelings of pleasure (libin and cohen-mansfield, ) . these findings position social robots as potentially ideal solution for older adults experiencing subjective loneliness. cacioppo et al. ( ) identified four distinct, underlying mechanisms of subjective loneliness-reducing interventions: (i) increasing social contact, (ii) improving social support, (iii) enhancing social skills, and (iv) addressing maladaptive social cognition. findings conducted with older adults living in assisted or group settings demonstrated interactions with social robots increased social contact with others (bradwell et al., ; leite et al., ; Šabanović et al., ) . however, less is known about active, communitydwelling older adults' behavioral responses to robotic pet use outside of a laboratory setting, during interactions within their own homes. given these diverse and potentially promising pathways for subjective loneliness-reducing reducing interventions, this study aims to examine the potential benefit of social robot use by community-dwelling older adults. in this study, we explored the perspectives and experiences of individuals who participated in an intervention with robotic companion pets within their own home. we examined patterns of usage, user acceptance, and perceived efficacy in reducing subjective loneliness in older adults. findings from this study will inform future robotic pet interventions for community-dwelling older adults. this study is part of a collaboration between aarp, unitedhealth group (uhg), and joy for all, a manufacturer of companion pets (ageless innovation lcc, ). the overall goal of this collaboration was to explore the potential role of companion pets in alleviating loneliness in older adults. this study was approved by the new england institutional review board (# ), an independent institution that reviews protocols for nonacademic institutions. this study was the second phase of a larger multiphase research study intended to better understand the healthrelated issues of older adults covered by aarp medicare supplement plans insured by unitedhealthcare insurance company (for new york residents, unitedhealthcare insurance company of new york). the primary purpose of the intervention was to determine if ownership and interaction with a robotic pet could decrease loneliness in older adults. the first phase of the study consisted of a program evaluation in which a sample pool of aarp medicare supplement insureds who previously reported loneliness were recruited for participation in the study. inclusion criteria for the study consisted of participants previously identified as lonely using either a screener that included the ucla , or screener administered via interactive voice support (ivr) survey in conjunction with aarp's aging strong initiative. the intervention was offered to participants residing in the states of washington and michigan. exclusion criteria included not a current enrollee in an aarp medicare supplement plan, less than years of age, on the "do not call" list, not having a valid phone number, and ownership of a pet. all other participants were considered eligible for participation. potential participants received pre-mailer scripts prior to an invitation to participate via telephone. participants received the animatronic pet of their choice (cat or dog) in the mail and were instructed to treat it as a pet (figures and ) . three post surveys were administered (upon receipt of the pet as well as and days later) to assess the amount of time spent interacting with the pet. in addition, twice a week for weeks, participants received an interactive voice reminder (ivr) phone call encouraging them to interact with the pet. the ivr phone call also asked participants to record if they had been interacting with their pet and if so, how much time on average they had been interacting with their pet. results of response bias analyses conducted for those who agreed to participate (n = ) versus those who declined (n = , ) and for respondents (n = ) versus non-respondents (n = ), indicated that survey participants were representative of the study population. overall, those who agreed to participate had similar characteristics as those who declined. however, those who agreed to participate in this study had higher levels of depression, more frequent er visits in the last months, and overall higher medical costs (but not drug costs) (p < . ). there were no differences for respondents versus non-respondents. at baseline, about half the respondents were between and and female, and most participants chose the animatronic dog ( %). in addition, % of participants reported previously owning a pet. the robotic pet offered several interactive features ( figure ). sensors in two locations of the head and cheeks of the pet responded to user touch and activated a reciprocal "nuzzling" effect. touch-activated sensors were located in the upper abdomen and back of the pet. a light sensor located in the pet's head detected when light entered the room and the pet vocalized in response to the light stimuli, depending upon the chosen setting. robot dogs barked depending on the setting, and robotic cats meowed and emitted a purring noise. robotic cats were offered in three color combinations: black and white, gray and white, and orange and white. robotic dogs were offered in a golden color (figure ). participants were not permitted to choose the color of their pet, only their preference for a dog or cat. companion cats currently retail for $ . and companion dogs for $ . . in this phase, a qualitative research study was conducted using standard qualitative procedures for conducting and analyzing semi-structured interviews. the journals of gerontology: social sciences, , vol. , no. full color version is available within the online issue. available within the online issue. full color version is purpose of these interviews was to elicit participants' experiences interacting with their robotic companion pet. participants who previously participated in the first phase of the study were recruited to participate in semistructured interviews. the interview guide consisted of questions. questions elicited feedback for a number of topics. consistent with related literature pertaining to robotic pet use, the interview guide included questions that asked participants to describe how they used and interacted with their pet, including how much time was spent with the robot, patterns of usage observed (day vs night), whether the pet accompanied participants outside the home or during errands, and whether participants detected that use of robotic pets influenced any of their daily routines and/or habits. additionally, interview guide questions asked participants to describe any physical or verbal interaction with the pet, including physical touch, reactions to pet's audio or haptic functions, and verbal communication with the pet. questions also asked participants to describe their motivation for joining the companion pet program, any feelings or emotions experienced as a result of interacting with their pet, including any observed influence on loneliness, mental and emotional health, and whether or not they named their pet. several questions explored psychological and emotional well-being, including subjective loneliness, by asking participants to describe an average day in their life, perceived opportunities to feel valued or useful, and opportunities to spend time with marital partners, family, and/or friends on a weekly basis, as well as participants' satisfaction with those opportunities for social connection. a few questions elicited participants' satisfaction with program administration, including reminder calls, clarity of instruction, and perceived accessibility of available support. lastly, participants were invited to provide feedback of any nature. eligible participants from the first phase of the study were stratified according to age range and gender, with the aim of recruiting an equal proportion of participants. following recommendations for a sample size of - participants in an interview study (lincoln and guba, ) , investigators planned an initial goal of interviews, after which they would assess if data saturation had been achieved and recruit additional participants if necessary (francis et al., ) . a marketing research company was provided with the full list of eligible participants, with instructions to recruit participants as evenly as possible among age range and gender, given the available sample. recruiters contacted participants by telephone, verified identity, explained the study, and scheduled interviews with the first participants successfully recruited. verbal consent was obtained prior to the start of the interview. interviews lasted approximately hr. no personal identifiers were collected. all interviews were audio-recorded and transcribed verbatim. investigators analyzed participants' transcribed interviews using qualitative description. qualitative description was an ideal methodology for this data as it draws from a naturalistic perspective, offers flexibility in commitment to a theory or framework, typically involves review of interview data, and allows for maximum variation sampling (kim et al., ) . two investigators (j. hudson and r. ungar) conducted a qualitative content analysis using an iterative, constant comparison process. during the coding process, both coders independently read transcripts, identified an initial code list, and developed operational definitions. then coders returned to the transcripts and conducted line-byline coding that included comparison and refinement of identified coding between both investigators. coders subsequently discussed, reviewed, and reread interview data to develop final coding and to reach consensus about meaning (ryan et al., ) . one investigator (j. hudson) coded all transcripts while the other coded % of the overlap. both investigators reviewed coding on overlapping transcripts to reevaluate passages coded across researchers, and the codes applied based on the assigned definition in the codebook (creswell and poth, ) . any conflict in assigned codes was settled through spirited debate until consensus was reached. next, both investigators examined the properties and categories of all codes to identify opportunities for categorization according to shared properties. investigators subsequently used this categorization of codes to develop overarching themes that described patterns of usage and provided a narrative of participants' overall use. throughout this process, investigators were mindful of the biases and existing perspectives they brought to the analysis. investigators worked to achieve qualitative rigor throughout data collection and analysis. to ensure trustworthiness of the interview transcripts (poland, ) , one investigator (j. hudson) closely monitored and compared audio recordings with transcripts to ensure verbatim description, while also noting significant context cues. both coders worked together closely during the ongoing, iterative development of the coding system to ensure validity and certainty of the findings (morse, ) . investigators were mindful of potential investigation bias and avoided narrow frameworks that would unfairly bias the interpretation of data while striving to maintain a neutral stance of the observed phenomenon. further, both investigators closely reviewed, discussed, and coded data as it was collected to assess the sufficient sample size for data saturation. investigators ultimately developed seven themes reflective of participants' experiences with their companion pets, as follows: openness to adoption of robotic pet, reactions to pet and its attributes, integration of pet in daily life, strategic utilization and forging new connections, deriving comfort and camaraderie, advice for future users, and recommendations for enhancing ownership experience. final coding was imported into nvivo (qip ltd., ), a qualitative software program. the following themes are discussed below, with exemplars. twenty individuals participated in the study, with an even distribution of males (n = ) and females (n = ). breakdown in age range is as follows: - (n = ), - (n = ), - (n = ), and and above (n = ). the average participant age was . all participants reported living in their own homes. living arrangements included living at home alone (n = ), with a spouse (n = ), with a child or grandchild (n = ), and with a caretaker (n = ). subsequent verification supported no participants lived in assisted or group settings. when asked to share their motivations for participating with a companion pet, participants shared several reasons including interest in exploring the experience of using a companion pet, a desire for maintenance-free pet companionship, and curiosity about the mechanics and underlying technology used in the pet. many participants previously owned pets, with five participants reporting their pet was recently deceased. owners of recently deceased pets identified clear distinctions between their beloved deceased pet and the robot, such as the inability to return affection, participate in interactive activities such as outside walks, and lack of a personality. however, they did describe experiencing comfort when interacting with the robotic pet in similar ways, such as sitting on the couch while watching television. for these individuals, robotic pet ownership appealed as an opportunity to experience maintenancefree pet ownership and to recapture the benefits of companionship without obligatory food and veterinarian expenses. a few participants reported their living arrangements would not accommodate a "live" pet, and they viewed the companion pets as way of circumnavigating that barrier. some were also intrigued by the notion of robotic pets and expressed curiosity about the underlying technology, and a few participants expressed a desire to potentially help others by sharing their feedback. as one participant explained, "it was the curiosity aspect more than anything else, wondering what the dog was like, what it would be like to have the dog, and what experience might be. that curiosity really was the linchpin to participating." other participants were intrigued by the opportunity and described their desire to derive companionship from the pet. participants who reported feeling subjectively lonely were especially interested in utilizing the pet as a personal companion. the majority of participants chose to name their pets, and consistently referred to the companion pet using its name. participants' accounts of their daily interactions with pets varied widely, often according to personal contexts. those who reported a more independent lifestyle outside the home and greater perceived social connectedness described a lesser degree of involvement with their companion pet. patterns of usage were categorized according to high and low engagement. low engagement was primarily characterized by interactions with the companion pet that were casual in nature or most often occurring in passing, with minimal physical contact and limited verbal communication. low-engagement users often described deliberate efforts to interact with their pet throughout each day in accordance with the study's directives but allowed that their pet only functioned in the periphery of their daily activities. for example, low-engager participants often described stationing the pet in a high-traffic area of the home such as the kitchen or living room, returning the pets' greetings as they moved throughout their home but otherwise ignoring or choosing not to interact with their pet. while these interactions may have included infrequent affectionate physical touch, these participants generally did not desire additional or prolonged interaction with their pet. as one participant explained, "i just pet him and rub him as i go by. we have him sitting on the couch in our living room." a few attributed their interactions to duty or obligation in accordance with their agreement to participate in the study. high engagement was characterized by frequent interactions with the pet, including frequent physical touch, communicating with the pet or using the pet to communicate with others, and including the pet in daily errands and activities. participants with fewer perceived social connections, especially those with fewer perceived opportunities to connect with others, described this higher degree of engagement characterized by greater quantity and quality of interaction with their pet. high engager use was most often reported by those who were less active, identified as less subjectively lonely, and perceived less social connectedness. these participants were more likely to report keeping their pets in close proximity when they moved throughout their home and they engaged in ongoing affectionate physical touch with their pet, such as cuddling, grooming the pet, sleeping with the pet, and holding the pet while watching television. some participants derived a sense of comfort and companionship from having the pet accompany them during their daily activities outside of the home. one participant who lived alone detailed the following daily ritual with her pet, buffer: the average day is, i get up at : and the first thing i do is make my bed. and then i say hello to buffer, because he's in the room, and then i get showered and dressed. and i then i pick up buffer and i have breakfast, and he's there. and i sing online, so sometimes i will actually hold in my lap while i sing. (woman in her s, living alone) in this way, participants who subjectively perceived fewer opportunities to interact with others reported increased interaction with their companion pet. most reported showing their pet to others, including family members, friends, neighbors, coworkers, clinicians, and those they typically encountered during their daily activities. however, the nature of the disclosure, and one's motivation for sharing their pet, varied. some members were motivated by a desire to share the technology and novelty of the pet. others shared their pets to facilitate entertainment, showcase the pet's interactive features, and to encourage others to consider acquiring their own pet. both high and low engagers of the pet noted that sharing the pet in public spaces increased potential opportunities to connect with others, especially individuals previously unknown to them. even participants who described themselves as outgoing or living a more social lifestyle reported bringing their pet along to public gatherings or spaces, and enjoying the interactions that were generated as a result. similarly, those who were shy or might have otherwise felt uncomfortable interacting with new acquaintances found integrating the pet into their daily activities outside of the home effective in forging new connections they otherwise would not have attempted. several participants relayed that friends, after interacting with their pet, were often interested in obtaining their own. in some instances, participants fielded requests from friends and acquaintances to loan their pets out. those who interacted with their pet to a lesser degree were more amenable to these requests. a few participants, most notably younger participants (ages - ) and low engagers, ultimately gave their companion pets away. in these cases, companion pets were "re-gifted" to interested friends, younger children in the family who regarded it a toy, older adults in care centers, or those with dementia: "it would have been better for someone who wasn't quite functional, who is maybe in a care facility. my wife gave it to one my friends in a care facility and she loved it." meanwhile, some participants (especially high engagers) often denied requests from acquaintances and/or friends to borrow their pet. others acquiesced only under certain conditions, such as having the pet returned within the same day. all participants agreed the companion pet was vastly different from a "live" pet with the ability to interact more extensively with its owner. however, many agreed the companion pet offered many interactive features that were reminiscent of their past experiences of having a "real" pet. when comparing the merits of a live pet and the benefits of a companion pet, participants varied in their estimations of the pet's realism. many, especially high engagers, judged the pet to be a close approximation to a live animal. younger (age - ) and low-engager participants were more likely to find the companion pet more "toy-like" and noted opportunities to improve the pet's realism. however, those who judged the pet to be a poor approximation of a "real" pet still noted the benefit of interacting with it. most noted their appreciation for the maintenance-free nature of the pet. among the majority of participants, favorite features included pets' vocalizations (barking or meowing) and nonverbal responses (head movement or blinking) in response to light and sound stimuli. many enjoyed their pet's "greeting" when a light or sound was detected. several used their pets' responsive barking/meowing to facilitate interactions such as petting and verbal communication. other favorite features were pets' "life-like behaviors," such as yawning, head turning, tail wagging, and the tactile heartbeat. many reported that these "realistic" features increased interaction with their pet and fostered comfort and comradery. participants described a number of benefits as a result of interacting with their pet. while high engagers were more likely to describe deriving comfort from the "presence" of their pet, the majority reported deriving benefits from interacting with their pets. most participants reported feeling a sense of calm or comfort as a result of holding, hugging, and affectionately interacting with their pet. for example, a low-engager who described herself as "too cognitively sharp" for the pet speculated her cortisol levels might have lowered. in addition, many described an improvement in their mood, and in some cases, increased happiness after interacting with their pet. certain interactive features such as pet vocalizations, "snuggling" motions, and the pet's heartbeat were identified as facilitators of this calming influence, and participants noted that others discerned how this effect positively influenced their behavior: i'm not as high strung… sometimes i get up in the morning and when i hit my power chair against the wall, i sort of get angry and i use foul language. then he barks. so that makes me stop. (man in his s, living alone) many participants perceived the pet as having a "presence" that positively influenced their subjective feelings of loneliness. this presence was keenly felt by those who spent significant time with their pet, as well as by low engagers living more active lifestyles. one participant, a semi-retired attorney who described a low degree of engagement with his pet explained, it's like he's alive over there and active. it's just one part of my life, this little puppy dog, but he's a part because he's there. but i live a pretty active life and a pretty active schedule, so it's not like i'm looking forward to seeing him when i come home, but he makes his presence known and that's good. (man in his s, living alone) similarly, a recently widowed participant who brought her companion pet along for errands outside the home explained the pet provided a comforting presence as she acclimated to her husband's absence. participants who lived alone and previously wished for someone to talk to perceived their pet as a proxy for a conversational partner and regarded it as a conduit for expressing their thoughts or feelings. in these cases, the participants regarded the pet not as an inanimate object that passively observed, but as an active partner who cared about their expressed concerns. as one participant explained: "you feel as though you're talking with an object that cares about whether you're talking to it or not." a few participants appreciated that conversations with their pet were confidential. those participants who reported this high level of engagement were most explicit in expressing the pet's influence in addressing their subjective loneliness. for these individuals, the companion pet was regarded as a friend or companion with whom they developed a strong attachment over time. some participants also described improved confidence and a renewed sense of purpose as a result of interacting and having to "take care of" their pet. when asked to advise future users, many indicated they would strongly encourage others to try the robotic pet, particularly those who are lonely, and to engage with it as much as possible. participants emphasized that using the pet was "easy" and required little effort. several explained the importance of interacting with the pet as much as possible in order to experience the greatest benefit. while some low engagers indicated their pet personally was not a good fit, they acknowledged the calming effect of the pet and recommended it for those who are lonely. a few high engagers encouraged future users to interact and communicate with their pet without fear of being stigmatized or considered "crazy." when asked to describe the ideal user for the robotic pet, low-engager participants typically described the composite of a lonely, less active, more advanced age adult with mobility issues and dementia. those with more active lifestyles and who perceived their social networks as dense judged they were a poor fit for the pet. distancing one's self from the perceived ideal user occurred with participants of all ages. notably, a participant in his s remarked: "i think as you get older, and your brain gets a little mushy. i think it would be a nice thing to have. but i don't think i'm to that point yet." meanwhile, participants who identified as being subjectively lonely or perceived themselves as socially isolated derived benefit from the pet and thought others in a similar situation would also find it beneficial. while many perceived their pet as having realistic features, over half of participants expressed a desire for further increasing the pet's realism by improving its appearance and capacity for movement. feedback included using softer material for fur and improving the pet's flexibility to better facilitate hugging and cuddling. several were interested in increasing the interactivity of the pet and suggested new functions, such as enabling the pet to learn skills and tricks. some also suggested adding new verbal communication features, such as pre-programmed responses and name recognition. many were also interested in adding the capability for walking, though a few acknowledged this as a potential fall hazard. many described an interest in having the pet follow them throughout the home, jumping up on furniture, and being walked outside while on a leash. participants also expressed an interest in additional outfits or grooming accessories, improved affordability for other friends and family members who sought to purchase a pet, adding a camera for security purposes and improving the overall battery life. our findings show social robots may provide comfort, companionship, and potential amelioration of subjective loneliness for older adults, particularly for those who perceive fewer opportunities for social connection. several studies have demonstrated the benefit of robotic pets in care centers (robinson et al., ; Šabanović et al., ; wada and shibata, ) and among those with dementia (jøranson et al., ; liang et al., ; moyle et al., ; robinson et al., ) . few studies have explored the benefit of companion pets for alleviating subjective loneliness, as well as the patterns of usage outside of a laboratory setting, among cognitively functioning, community-dwelling older adults. results of this study reify previous findings indicating increased communication with the robot and other humans. participant feedback further reinforces the need for social robot developers to actively integrate feedback from older adult test users in the design and development processes. in a recent study comparing the preferences of roboticists and older adults, participants were encouraged to indicate their favorite companion pet model. while older adults in this same study overall preferred the joy for all cat and its more interactive features as compared to less responsive robotic models, they still desired a greater degree of interactivity and playfulness (bradwell et al., ) . community-dwelling participants in our study echoed these sentiments, with many requesting robotic features that accommodated their lifestyles and reflected the degree to which they were able to enact an autonomous, independent lifestyle. the joy for all companion pet models offer a degree of interactivity that perhaps signals a progression in social robot development. however, participant feedback further confirms the need for more advanced features that accommodate the needs of older adults, not as passive users, but as "technogenerians" adeptly managing technology to maintain health and independence (joyce and loe, ) . younger participants in this study desired a model that offered greater responsiveness and spontaneity, expectations that defy the stereotype of older adults as passive users. ideally, social robots functioning as companion pets should offer a range of function and interactivity to accommodate the widely ranging abilities and skills of older adults along the aging trajectory. older adults' manipulation of robotic pets varies according to the extent of their cognitive impairments, with more impaired individuals interacting with the pet to a lesser degree (libin and cohen-mansfield, ) . accordingly, active and community-dwelling older adults will likely benefit from greater utility and diversity of functions to foster incorporation of the pet into their daily schedule and habits. as noted in previous studies, these individuals created, and simultaneously distanced themselves from, a composite of the ideal user as lonely, socially isolated or having cognitive impairment (mcglynn et al., ) . it has been suggested that this composite may reflect a negative age stereotype (lazar et al., ; neven, ) . however, it is unclear if this stigma applies to participants in this study, who were able to engage with the robot in the privacy of their own homes and subsequently concluded the robot did not offer the desired personalization and interactivity. users who considered themselves active and independent noted the need for greater interactivity and subsequently judged themselves to be a poor candidate for use of the robot. in this case, it is likely that participants' distancing from the ideal is owed to the desire for more realistic, interactive features. this finding further confirms how different preferences and patterns of usage in varying contexts requires adaptable interactivity. utilization and benefit derived from the robotic pets varied according to participants' personal contexts, revealing which subgroups potentially benefitted the least from participation with their pets. despite enjoying companionship with their pets and showing them to others, younger participants ( s- s) were among those most likely to report low engagement with their pets and most likely to gift their pets to others. those with active lifestyles and viable social connections were not ideal candidates for social robots and frequently requested greater interactivity and functionality of the pets. these results suggest that socially connected individuals with the capability of enjoying an active lifestyle outside of their home would benefit the least from robotic pets with limited features. conversely, certain subgroups reported deriving significant benefit from their robotic pet. subjectively lonely older adults with fewer perceived social connections, especially those living alone and homebound, were most often among those who integrated the pet into their daily schedule, regularly communicated with the pet, and described experiencing comfort and companionship pet interactions. further, those who experienced the death of a pet or spouse also derived companionship from their pet. interventions using social robots with limited features may be most appropriate for these subgroups. these findings identify ideal subgroups of older adults who are more likely to benefit from the use of social robots. however, the collection of these data and the resulting findings should be properly contextualized as occurring prior to the advent of the covid- pandemic. older adults face a higher risk of severe illness from covid- , with individuals aged or older at the greatest risk. while practicing physical distancing contributes to efforts to flatten the curve, older adults may experience increased anxiety and depression as a result of limited travel and being restricted to their homes. a recent survey found the prevalence of psychological distress in a sample of adults in united states was higher in during the covid- pandemic (mcginty et al., ) . given new constraints related to physical distancing and their potential contribution to social isolation, future studies should examine what appeal and/or effect social robots may have for previously active, socially connected adults under quarantine. similarly, future studies should examine how the use of social robots may potentially mitigate psychological distress for older adults quarantined in care centers and not permitted faceto-face visits from loved ones. these study findings provide insights into the potential benefit of robotic pets for community-dwelling older adults interacting with the pets in their own homes, and demonstrate the need to explore applicability during pandemic conditions. participant feedback yields supporting evidence demonstrating that robotic pet use may positively influence older adults' perceived loneliness and mental and emotional health, particularly for isolated and subjectively lonely community-dwelling older adults. furthermore, participant feedback potentially supports the notion that a robotic pet intervention may successfully meet two of the four points of criterion for assessing the efficacy of loneliness-reducing interventions (cacioppo et al., ) in this instance: improving social contact and enhancing social skills. it should be noted that these findings are consistent across gender, as compared to previous studies disproportionately compromised of female participants. given the variability of use and preferences among older adults, subsequent studies should include healthy older adults in the ongoing development of robotic pets (frennert and Östlund, ) . this study did not directly capture interactions between participants and their robotic pets, instead relying on participants' recall; thus discrepancies in actual versus reported interactions could exist. future research with communitydwelling older adults should consider the use of animatronic pets equipped with sensors that more objectively measure interaction and travel. this cross-sectional study provides valuable insight about potential benefits experienced immediately after participants' initial introduction to the pet. longitudinal analyses are needed to understand how the findings of this study bear out over the long term, and whether mitigation of subjective loneliness among socially isolated participants bears out over time. while lonely and socially isolated older adults may derive benefit from the use of their pet, less is known about community-dwelling older adults' concurrent attempts to continue socializing with others. potential ethical issue may arise for lonely older adults who become dependent on their companion pet for companionship or social connection. participants who agreed to participate had higher levels of depression, suggesting a potential oversampling of this population. given participants may have been motivated by a desire for increased social contact and companionship, participant feedback may not be representative of a randomly chosen sample of older adults. further, favorable impressions of the pet may be overrepresented in this sample. finally, it should be noted that participants in this study were gifted their robotic pet. while the manufacturer's offerings include models at varying price points, the cost of obtaining a pet may be a barrier for some older adults. robotic pets may provide benefit for older adults experiencing subjective loneliness and perceived social isolation by providing comfort, companionship, facilitating new social connections, and serving as a proxy for a conversational partner. however, robotic pets with limited functionality may fail to address the needs of active older adult users. participant feedback suggests that robotic pets may yield the most benefit for subjectively lonely older adults living alone with fewer connections and subjectively lonely adults experiencing the loss of a spouse or pet. these findings can inform future development and production of robotic pets to accommodate the varying needs and preferences of community-dwelling older adults. existing robotic models should explore ways of improving realism and the capacity of interactive play with their owners, and accommodate older adults as active, engaged users of technology. future interventions intended to reduce loneliness may consider implementing use of robotic pets with increased interactivity. finally, future studies should examine the potential efficacy of robotic pets in alleviating psychological distress for quarantined older adults with varying connectedness. this work was funded by the supplemental health insurance program. all authors are employed or contracted by unitedhealth group or asi services, inc. however, their compensation was not dependent upon the results obtained in this research, and the investigators retained full independence in the conduct of this research. joy for all companion pets loneliness and social connections: a national survey of adults and older lack of social support in the etiology and the 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alone living with seal robots-its sociopsychological and physiological influences on the elderly at a care house none declared. key: cord- -lgee ers authors: liddle, jennifer; pitcher, nicole; montague, kyle; hanratty, barbara; standing, holly; scharf, thomas title: connecting at local level: exploring opportunities for future design of technology to support social connections in age-friendly communities date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: lgee ers social connectedness in later life is an important dimension of an age-friendly community, with associated implications for individual health and wellbeing. in contrast with prior efforts focusing on connections at a distance or online communities where the digital technology is the interface, we explore the design opportunities and role of technology for connectedness within a geographically local community context. we present findings from interviews with older adults and a linked ideation workshop. our analysis identified shared concerns and negative perceptions around local relationships, connections and characteristics of the geographical area. however, local connectedness through technology was largely absent from day-to-day life and even perceived as contributing to disconnection. by uncovering how older adults use and perceive technology in their social lives and combining these findings with their ideas for improving local connections, we highlight the need for thoughtful consideration of the role of technology in optimising social connections within communities. our research highlights a need for design work to understand the specifics of the local context and reduce emphasis on technology as the interface between people. we introduce an amended definition—‘underpinned by a commitment to respect and social inclusion, an age-friendly community is engaged in a strategic and ongoing process to facilitate active ageing by optimising the community’s physical, social and digital environments and its supporting infrastructure’—to conceptualise our approach. we conclude by suggesting areas for future work in developing digitally connected age-friendly communities. social connectedness in later life is important for health and wellbeing. consequently, making it easy for people to develop and maintain social relationships is a fundamental ambition of 'age-friendly' communities. this local, place-based, policy approach recognises that physical and social environments are key determinants of whether people remain independent, autonomous and healthy in later life. human-computer interaction (hci) researchers are directing increasing attention towards the role of technology in shaping and supporting social relationships in later life. much of this work focuses on online communities or connecting across geographical or generational distances, where digital technology is the interface or infrastructure for connection. in addition, approaches commonly place emphasis on addressing technological inexperience, or on physical or cognitive impairment and decline. in this paper, we are interested in considering technology and connectedness in later life within a specific local context, and exploring how innovation in social connection can be age-friendly and embedded within such physical community settings. we consider older adults as a heterogeneous group, rather than a group marked by singular identities of health, cognitive status, or technological proficiency. nevertheless, our place-based approach aims to identify common values and experiences shared by people living in the same geographical area. life events such as retirement, along with experiences of building and maintaining social connections over the life course, will also have implications for how and why older adults wish to develop and sustain proximate relationships in particular ways. we suggest that considering these topics enables a deeper understanding of how to design for a digitally connected age-friendly neighbourhood, where both the design process and its outputs are age-friendly. our paper presents findings from a study comprising two phases: qualitative interviews with older adults; and a linked workshop ideation process to engage interviewees in beginning to consider how connections within their local area might be enhanced over time. the contributions of our paper centre around a context-specific and bottom-up approach to designing for increased local connectedness in later life. the importance of this topic has since been emphasised by the covid- pandemic, heightening awareness of the need to consider ways to maintain and create social connectedness, particularly at a local level. our aim is not to design a technological output. instead, we see our approach as prioritising a crucial, and often neglected, stage in technology design, which provides important insights that would be required for any future stage of a design process that aimed to design or create an actual technology. themes that emerged from our interviews suggest that participants viewed technology as acceptable when it filled a 'gap' and did not have too many negative impacts on everyday life. our starting point for the linked workshop was to consider some of these 'gaps' in local connectedness that interview participants had described. the workshop activities were used to facilitate participants in thinking creatively about addressing specific local challenges, or 'gaps' in connectedness. in drawing together participants' ideas about spaces, processes and mechanisms that might address these local challenges, we conclude the paper with implications that offer scope for further exploration and consideration in terms of how technology might support the operationalisation of local people's ideas for improving face-to-face connections in age-friendly community settings. growing interest in what makes places 'good' to grow old in has led to an increasing focus on the 'age-friendliness' of different types of environments [ ] . despite variation in emphasis between models of age-friendly environments, most approaches promote consideration of how policies, services and structures can integrate physical and social environments, supporting social engagement and connection [ ] . our work adopts the following conceptual definition, with its emphasis on age-friendliness as commitment to a process rather than a standard to be reached: 'underpinned by a commitment to respect and social inclusion, an age-friendly community is engaged in a strategic and ongoing process to facilitate active ageing by optimising the community's physical and social environments and its supporting infrastructure' [ ] . the adopted definition of age-friendliness shapes our research design and methods, with its emphasis on community engagement and the participation of older people in processes to optimise the environment to support social connections. we also draw on concepts from environmental gerontology, such as 'ageing in place' to understand the importance of the local area in older people's lives. an overarching premise of an age-friendly community is that it is 'friendly for all ages and not just "elder-friendly"' [ ] . even so, the argument that older people are 'able to remain more independent by, and benefit from, ageing in environments to which they are accustomed' [ ] makes it all the more important to consider how environments can support people 'ageing in place' to optimise their social connectedness within their local area. this has become even more apparent during the covid- pandemic, which has exposed the need for digital connection as an alternative to face-to-face interactions. similarly, finding new ways to connect, even with people in proximate locations, has become a greater priority. there has also been a strong emphasis on tackling the counterparts of social connectednessloneliness and isolation. warnings of the 'loneliness epidemic' and its associated public health implications are prevalent in media discourse [ ] [ ] [ ] , and the uk government appointed the world's first minister for loneliness in [ ] . accordingly, responses to the drive for increased social connection have often focused on mitigating unpleasant experiences, risks and deficits at an individual level [ ] . efforts along these lines reflect and uphold persistent ageist stereotypes that fail to acknowledge the roles that older people (can) play in communities, or their potential to contribute innovative ideas or create a voice for themselves [ ] [ ] [ ] . indeed, technology is often presented as the ideal way of solving these 'problems' faced by older adults [ ] . ten bruggencate et al. draw our attention to the predominant focus on loneliness and/or isolation in studies about social technology, ageing and relationships [ ] . in contrast, a growing body of work on social connectedness in later life challenges the image of older people as lonely and isolated. population ageing is leading to increasing numbers of older people, thereby increasing the number of older people in society who experience loneliness. however, loneliness affects only the minority of older people, including the oldest old [ ] [ ] [ ] . the likelihood of reporting feeling lonely decreases with age, with younger adults ( - years) reporting loneliness more often than those in older age groups [ ] . while older adults may have smaller social networks, they are often more involved in the community than younger adults-socialising with neighbours, participating in religious organisations and volunteering [ ] . however, even if social reciprocity and meaningful interactions are desired and enacted by older people, infrastructural barriers can, and do, impede the quantity and quality of such connectedness [ ] . technology offers the potential for scalable and cost-effective interventions to address barriers to connectedness. the design, or adoption, of digital technology to support social relationships in later life often results in technology being the core interface for connection between people, rather than a route to facilitating face-to-face connections by overcoming barriers. for example, online communities are promoted as presenting opportunities for older people to meet and interact with peers [ ] [ ] [ ] [ ] . in this interfacing role, technology is a bridge across distances. lindley et al. comment that much hci research related to relationships focuses on ways to maintain feelings of connectedness or express intimacy at a distance [ ] . distances being bridged may be geographical, for individuals living in remote areas or wanting to connect with people with whom they share interests, friendship or familial bonds. distances may also be generational, where, despite intentions to the contrary, technology replicates asymmetrical family interactions [ , , ] . growing proportions of older people are now using digital technologies. in the uk, % of adults aged - , and % of adults aged and over use the internet [ ] . thus, the majority rather than a minority of older people are technologically connected, suggesting a need to understand more about how this diverse population uses, and feels about, technology for connecting with others. the few studies that have explored older people's attitudes towards, and perceptions about, communication and connection suggest that rich interactions are valued above lightweight connections offered by newer technologies [ , , ] . again, this work primarily considers the capacity of digital technology to bridge geographical or generational distances, where more traditional technologies such as telephone and email are often preferred. thoughtful and meaningful interactions are the goal, and technology provides the interface. research methods centre around questions about how older adults use, or would choose to use, technology in their social relationships. for instance, sayago et al. report on research with older people (across six studies) that examined situated technology use and the reasons why participants did, or did not, incorporate particular forms into their everyday lives [ ] . in this way, technological interfaces are often in-built as fundamental foundations for designing for connection, diminishing considerations of technology in non-interfacing roles. research that has explored ways to improve geographically proximate connections has also tended to concentrate on a prominent role for technology, often studying online community networks. these include bespoke online communities for older adults, or those formed on more widely used social networking platforms. righi et al. focussed on how older people's use of social networking sites could be used to promote their involvement in both online and offline local communities [ ] . while participants used, for example, facebook to find out information about the local area, most did not post or share information or send messages to others. instead, these interactions took the form of face-to-face conversations. on this basis, the authors conclude that proximity and face-to-face contacts should be kept in mind when designing online community networks. we would extend this argument further, to suggest reversing the design process. such a process would design for proximity and face-to-face contact in offline communities, with technology kept in mind in a background, less visible, role. the research described above concentrates on technology as the interface for connection between people. while the potential of technology to foster involvement in local communities has been explored, less attention has been paid to understanding and drawing on context-specific factors to develop approaches to promote connection in local areas with, rather than for, older people. this would be a fundamental approach for any community engaged in the ongoing process becoming (more) age-friendly. an effective strategy in one community will not necessarily translate to a community with different geographical, social or structural features. likewise, the attitudes of older people towards technology will vary individually and across communities and countries. in their 'manifesto for change' in age-friendly cities and communities, buffel et al. emphasise the necessity of ensuring the empowerment and recognition of older residents in order to achieve age-friendliness [ ] . for these reasons, we adopted a bottom-up, place-based approach that can be responsive to local needs, preferences and resources. we recognise community as an inclusive concept, with the participation and empowerment of members (particularly older people) being fundamental to its creation and functioning [ , , ] . the following sections present the methods and findings of our study. our research design (in-depth interviews followed by an ideation workshop) draws on key concepts, theories, gaps and definitions in the literature outlined above. it is a bottom-up place-based approach that focuses on local needs, preferences and resources. it prioritises the participation of older people in exploring context-specific routes to local connection that present opportunities for future design of technology. we see our participants as crucial to developing ideas to increase or improve connection. as residents within the local area, they have a wealth of knowledge and experience and are best placed to identify resources, ideas and options that can lead to context-specific routes to connection. our overall aim within this study is to begin exploring context-specific routes to local connection that do not start the design process with attempts to design technological interfaces. discovering issues or opportunities for increased connection at a community level is the first step in this process. these opportunities and 'gaps' also need to be considered alongside insights into the current practices and perceptions of older people regarding technology in their social lives. once opportunities for increasing connection have been identified, ways to address these can then be explored by older people with local expertise and knowledge. therefore, in practice, the workshop methods were designed after analysis of our interview data so that we could draw on the interview findings as the starting point for workshop activities and discussions. however, for structural clarity, the methods for both the interviews and workshop are presented first in this paper, followed by the findings from our analyses. the first phase of our study aimed to explore opportunities for designing to improve proximate social connections for older people living within a geographically identified 'community'. we also wanted to know more about how and why research participants were using technology, or not, in their social lives. qualitative interviews were an appropriate method for exploring these two topics, with their potential to elicit personal accounts that help people to 'make explicit things that have hitherto been implicit-to articulate their tacit perceptions, feelings and understandings' about their social lives and technology [ ] . the study setting was an electoral ward (district) within a city in the north of england, uk, chosen for its proximity to the research team's institutional location. just over % of the around , people living in this geographical area are aged or over (compared to % overall in england and wales). it is also one of the most ethnically diverse and socially deprived wards in the region [ ] . following institutional ethical approval (ref. ), we recruited older adults ( women, men) to take part in audio-recorded interviews. sixteen interviews were with individual participants and three interviews were with couples living in the same household who chose to be interviewed together. our only inclusion criterion was that participants were aged or over. however, we also sought to achieve a diverse sample in terms of age, gender, ethnicity, social connectedness and living arrangements. table summarises participant characteristics. participants were aged between and and had been living in the area for between seven months and years. one participant was asian and the remaining participants were white. eight participants were living alone, and the others lived with at least one other person (a spouse/partner ± extended family). with the exception of one participant who was working part-time, all participants were retired. recruitment was via face-to-face conversations at community events and locations (such as a weekly café held in a local church) and contact details shared by community groups and organisations based in the area. we made substantial efforts to achieve a sample with greater ethnic diversity, including seeking assistance from individuals running local organisations and groups for people from non-white backgrounds, and posters in local culturally diverse food and clothing shops. we also made provisions for language translation in interviews. however, in the time available, we were unable to identify additional people from different ethnic groups who were willing to take part in an interview. longer-term development of relationships within the community would likely be needed to increase interest and trust, which was not possible in a study of this scale. all potential participants were given an information sheet about the study and a copy of the consent form to read. interviews were arranged at times to suit participants, and they were offered a choice of location. one participant chose to meet for their interview in a community building and all other interviews were conducted in people's own homes. after completing the consent form and giving an opportunity for the interviewee to ask any questions, we audio-recorded the interview with the participant's agreement. interviews were conducted by jl, hs or np. we initiated the interviews with a narrative approach, asking individuals to tell the story of their social lives since they had been living in the area. this facilitated the exploration of each individual's own concerns, meanings and priorities related to their social lives, rather than these being imposed by predetermined questions [ ] . the same question was asked at the beginning of each interview: 'can you please tell me the story of your social life while you've been living in [this area]; your relationships with family, friends, neighbours and other people?'. participants were asked to talk about any events and experiences that were important for them, and invited to take as long as long as they needed to tell their story. this narrative section of the interview was followed by supplementary probing questions to explore areas of particular interest, including the role of technology in their social lives. these questions were not pre-defined in order that interviewers were free to explore anything that they felt was of interest and relevant to the overall aims of the study, maintaining a natural and spontaneous flow within the interview. brief reflective field notes were made by interviewers after each interview. electronic data files were stored in password-protected folders in the university filestore. interview recordings were transcribed and names were anonymised. we then completed initial inductive coding [ ] of the data to explore (a) opportunities to improve connections at a local level, i.e., factors that had the potential to impact negatively on people's geographically proximate social relationships in terms of quality, quantity or satisfaction; and (b) participants' engagement with technology in relation to their social lives generally. codes were organised under themes, following the process outlined by braun and clarke [ ] . for example, codes such as 'places people used to socialise no longer exist', 'many buildings are not accessible', and 'there are few facilities' were grouped together under the theme 'few local places to socialise'. coding and theme development were completed independently by two researchers (j.l., n.p.) and then discussed and refined with all members of the research team. while all names used in this paper are pseudonyms, participants in photographs gave consent for their images to be included in research outputs. the second phase of the study comprised an ideation workshop. we drew on the following conclusions from our interview analysis when designing the workshop: • there were concerns and perceptions about local community connections and characteristics that offered opportunities for design; • our participants predominantly used technology to connect with family, or friends at a distance; existing local technological connections in their social lives were less obvious; • many participants were actively using a variety of technologies, but their willingness to do so depended on perceptions of unmet needs and balancing the negative aspects (additional work, potential contribution to face-to-face disconnection) in their everyday lives. we designed the workshop to explore and generate ideas to improve and optimise social connections in the local area, focusing on four of the opportunities we identified in our interview analysis. based on the in-depth understanding about participants' use and perceptions of technology that we gained from the interviews, we designed 'playful' workshop activities that deliberately did not ask participants explicitly to consider how technology could address issues in local social connections. instead, we wanted to begin by eliciting participants' thoughts about the best ways to tackle these issues before considering any technological needs that arose from these suggestions. this approach avoids the tendency of previous research to foreground technology at the start of the design process. by deliberately not seeking to design a technology or technological interface in this study, we could instead reflect on the potential needs or roles for technology once we knew what type of interventions our participants had suggested. our approach also fitted well with our desire to draw on participants' knowledge, experience and capacity for creative thinking, and was in keeping with our aim of developing approaches to promote connection with, not for, older people, prioritising their participation in a bottom-up design process. all interview participants were sent a postal invitation to the workshop. eleven individuals initially confirmed their availability and nine attended on the day ( women, men). these individuals were aged between and and had been living in the area for between and years. the workshop was held in a church hall in the local area and refreshments were provided. participants were asked to read and complete the consent form on arrival. consent to being photographed was optional. the workshop was structured around four opportunities to improve local social connections that we identified as themes through our interview analysis. each theme represented shared concerns and negative perceptions about local relationships, connections and characteristics of the area that participants had talked about. the four themes were 'few local places to socialise', 'not knowing neighbours well', 'absence of a shared community feeling', and 'activities on offer not always conducive to socialising or making new friends'. these themes were chosen to take forward in the workshop based on their content being both appealing and generic enough for all participants to engage with, regardless of their individual circumstances and experiences. in line with age-friendly models, our aim was for a bottom-up approach in which workshop attendees' participation and contributions were fundamental to the resulting design ideas [ ] . confronting ageist stereotypes, we also wanted to capitalise on participants' creative abilities and ingenuity along with their knowledge and experience as residents within the local area. in line with these priorities and our aim to explore participants' thoughts about how to improve connections at a local level without a specific focus on technology, we designed a range of playful ideation (idea-generating) activities to scaffold workshop discussions. choosing activities to maintain a 'playful mindset' was a central ambition in our design, as this has been identified as a key enabler when ideating [ ] . participants worked in small groups, with each group asked to choose one theme to focus on throughout the activities. we gave groups the option of completing one, some, or all of the activities, depending on which appealed to them and how much time they spent on each activity. all groups tried at least two of the three activities: participants were asked to generate ideas about how to cause the issue/theme or how to make it worse. this generated a list of problems or criticisms that participants were then asked to reverse or convert into positive ideas or solutions ( figure ). an example idea from participants was to remove the internet. they then converted this into an idea to provide free internet access alongside tv licences. mindset' was a central ambition in our design, as this has been identified as a key enabler when ideating [ ] . participants worked in small groups, with each group asked to choose one theme to focus on throughout the activities. we gave groups the option of completing one, some, or all of the activities, depending on which appealed to them and how much time they spent on each activity. all groups tried at least two of the three activities: participants were asked to generate ideas about how to cause the issue/theme or how to make it worse. this generated a list of problems or criticisms that participants were then asked to reverse or convert into positive ideas or solutions ( figure ). an example idea from participants was to remove the internet. they then converted this into an idea to provide free internet access alongside tv licences. this activity involved imagining how a famous person or character (fictional or real) with a wealth of skills, resources or power might respond to the issue. one group chose vladimir putin, president of russia, as their inspiration, with ideas that reflected their views on his leadership style, including mandatory socialising (e.g., meeting for a chat over a cup of tea or coffee) at particular times of day with street marshals to monitor and guarantee people's involvement. the third activity began with each group member writing an initial idea on a piece of paper which was then passed around the group for others to contribute to, comment on, or develop the initial idea ( figure ). an example of this process was an initial idea to have more benches and ice cream vans driving round parks to encourage families with children to stay and chat. this resulted in the suggestion that the vans could double-up to provide other services like newspapers or bread, which might attract a wider range of people. this activity involved imagining how a famous person or character (fictional or real) with a wealth of skills, resources or power might respond to the issue. one group chose vladimir putin, president of russia, as their inspiration, with ideas that reflected their views on his leadership style, including mandatory socialising (e.g., meeting for a chat over a cup of tea or coffee) at particular times of day with street marshals to monitor and guarantee people's involvement. the third activity began with each group member writing an initial idea on a piece of paper which was then passed around the group for others to contribute to, comment on, or develop the initial idea ( figure ). an example of this process was an initial idea to have more benches and ice cream vans driving round parks to encourage families with children to stay and chat. this resulted in the suggestion that the vans could double-up to provide other services like newspapers or bread, which might attract a wider range of people. data collection in the workshop comprised ideas written by participants on the templates provided (see figure for example data). all data were stored in a locked filing cabinet within an access controlled workspace. the workshop activities generated an extensive list of ideas and suggestions for facilitating social interaction within the immediate local area. each group wrote down every idea that resulted from the activities they completed. after the workshop, we combined these ideas into one longer list and grouped and organised them under three overarching themes and sub-themes that captured the overall range, content and types of ideas [ ] . themes and sub-themes were developed by two researchers (jl, ts) and then discussed with all members of the research team. as described earlier, the interview data were coded to explore a) opportunities to improve connections at a local level, i.e., factors that had the potential to impact negatively on people's geographically proximate social relationships in terms of quality, quantity or satisfaction; and b) participants' engagement with technology in relation to their social lives generally. the following sections outline the main findings in relation to each of these topics. in our interviews with participants, we adopted a place-based approach to focus in on social lives at a geographically local level. it soon became apparent that there were many aspects of the locality that participants were content with, or did not wish to change. for example, some described strong friendships and connections with local friends and neighbours that had endured over time. others were actively involved in attending and/or organising local social events. however, there were shared concerns and negative perceptions around local relationships, connections and characteristics of the area that offered opportunities for further exploration as topics to design around. our analysis of the interview data specifically aimed to identify these opportunities to improve connections at a local level, by pinpointing factors that had the potential to impact negatively on people's geographically proximate social relationships in terms of quality, quantity or satisfaction. we report here on the four of these themes that were taken forward to the ideation workshop. these were chosen from a larger number identified, based on the criteria that they would be both appealing and generic enough for all participants to engage with, whatever their individual circumstances and experiences. table outlines the four themes, along with linked examples from the interview data. data collection in the workshop comprised ideas written by participants on the templates provided (see figure for example data). all data were stored in a locked filing cabinet within an access controlled workspace. the workshop activities generated an extensive list of ideas and suggestions for facilitating social interaction within the immediate local area. each group wrote down every idea that resulted from the activities they completed. after the workshop, we combined these ideas into one longer list and grouped and organised them under three overarching themes and sub-themes that captured the overall range, content and types of ideas [ ] . themes and sub-themes were developed by two researchers (jl, ts) and then discussed with all members of the research team. as described earlier, the interview data were coded to explore (a) opportunities to improve connections at a local level, i.e., factors that had the potential to impact negatively on people's geographically proximate social relationships in terms of quality, quantity or satisfaction; and (b) participants' engagement with technology in relation to their social lives generally. the following sections outline the main findings in relation to each of these topics. in our interviews with participants, we adopted a place-based approach to focus in on social lives at a geographically local level. it soon became apparent that there were many aspects of the locality that participants were content with, or did not wish to change. for example, some described strong friendships and connections with local friends and neighbours that had endured over time. others were actively involved in attending and/or organising local social events. however, there were shared concerns and negative perceptions around local relationships, connections and characteristics of the area that offered opportunities for further exploration as topics to design around. our analysis of the interview data specifically aimed to identify these opportunities to improve connections at a local level, by pinpointing factors that had the potential to impact negatively on people's geographically proximate social relationships in terms of quality, quantity or satisfaction. we report here on the four of these themes that were taken forward to the ideation workshop. these were chosen from a larger number identified, based on the criteria that they would be both appealing and generic enough for all participants to engage with, whatever their individual circumstances and experiences. table outlines the four themes, along with linked examples from the interview data. beginning with the first of the four themes, most participants reported that there were few places in the immediate local area that they could use for socialising beyond their own homes. they described how there was no central community centre in the area, and no clearly distinguishable main high street. perceptions about the lack of local options contrasted with participants' opinions about the venues, centres and cafés available in other areas where they felt that community spaces and cafés were prominent and actively used and adopted by people living there. some participants were happy to socialise at home, but others saw this as too much of a burden or did not feel comfortable inviting people into their home. a noteworthy and unique characteristic of the local area highlighted by participants was the historic covenant on the land in the vicinity, preventing any licensed premises or pubs from operating. in the face of limited options in terms of usable spaces, local churches often hosted (or were booked to host) activities and events. however, this itself was a deterrent to some participants who felt uncomfortable attending events that had a religious connection-even if religion was not intended to be part of the event, such as a community café. overall, the perspective was that the community's physical features and built environment did not facilitate face-to-face social activities and interactions. the second theme (not knowing neighbours well) did not apply to all interview participants. in fact, some participants described their neighbours as good friends. these interviewees lived in quieter, more spacious streets, accommodating larger houses with gardens. other interview participants felt very disconnected from their neighbours. those living in particularly 'neighbourly' streets were aware that their situations were unusual in the wider local area where different road and housing types and tenures were more dominant, and fewer longstanding residents were living alongside the same neighbours for extended time periods. population churn, the movement of people in and out of streets, was perceived as a factor influencing the extent to which participants knew their neighbours. growing families and the number of properties available to rent in the area were cited as reasons behind this movement. streets were often busy with traffic-a factor that participants identified as not being conducive to unplanned meetings or chats with neighbours. while the physical proximity of neighbours potentially offered the most geographically close opportunities for social interaction, this had not translated into actual interactions for many participants. in particular, participants indicated that local issues of population mobility and transport routes contributed to the under-development of these relationships. the essence of the third theme (a lack of shared community feeling) was expressed by many participants. some attributed the absence of community to the area's geographical characteristics and location within the wider city, including the proximity of a motorway and the absence of a central focal point, or main high street, in the area. interview participants also commented on the lack of interaction between people of different ethnic and cultural backgrounds, despite the fact that the area was home to a diverse population. some talked about how this had been a longstanding issue, first noticed when their children were at school. together, both the physical environment and the population makeup of the area appeared to contribute to participants feeling that there were physical and cultural divisions within the geographical community. the fourth theme illustrates the complexity of developing new connections and relationships that extend beyond acquaintanceship: activities on offer are not always conducive to socialising or making new friends. even when participants were meeting people and seeking new friendships, these interactions did not often translate into deeper relationships. some participants described attending regular or one-off activities where they felt that the type and format of sessions were not helpful for getting to know people. for example, the focus was on a particular activity so chatting was only possible during brief time periods while setting up or packing away. another barrier was that some participants were more passive than others, and did not initiate conversations or connections themselves. in addition, participants mentioned that the same volunteers or people were often involved in several different groups and activities, resulting in a smaller pool of people to form friendships with. in other instances, it was simply that occasional casual conversations participants had with others did not result in deeper friendships or relationships that were sustained or developed beyond interactions at the events themselves, and individuals, therefore, remained acquaintances. taken together, these themes demonstrate clear barriers in, and characteristics of, local community connections. the themes capture issues that were impacting on the quality and quantity of participants' relationships in the local area, offering opportunities for participatory design processes to address these. alongside identifying opportunities to improve connections at a local level, the other focus of our analysis of the interview data was on understanding more about participants' existing engagements with technology in relation to their social lives. this engagement ranged from minimal (i.e., landline telephone only) to extensive (including social media, real-time audio/video interactions and applications). we use eight central themes to capture participants' accounts of the existing roles that technology played, or did not, play in their social lives. these themes, and examples of the data that support them, are outlined in table . capturing and sharing images marie: "it's got an excellent camera. i use it as a camera because i'm useless at taking photographs otherwise." simon: "see, if marie uses a camera to take somebody's photograph, and eventually either cuts them in half or chops their head off, you know, which is-but, with this phone, it's absolutely brilliant." marie: "yes, yes." simon: "the pictures that she's taken when she's been on holiday and things, absolutely superb." "i get loads of photographs of the children when they're opening birthday presents. their mother takes a photograph and sends it with a comment on what they said when they were trying on things." (lynne) the first theme about the role of technology in interviewees' social lives focuses on its use to connect participants with people in geographically distant locations. in fact, many of the digitally mediated interactions described by participants bridged geographical distances. applications and platforms such as facetime, facebook and whatsapp (along with traditional landline phone calls) were commonly used to keep in touch with friends and family located in geographically separate locations. grandchildren were frequently mentioned as being a priority in seeking to connect face-to-face at a distance. while the financial savings of free long-distance technological connection were noted and appreciated by some, interviewees also reflected on the emotional value of being able to stay visually connected with loved ones. for claire, this connection even changed her perception of the duration of time passing between in-person interactions, making it feel like she had seen her son in person more recently than was the case in reality. in contrast to those using technology to bridge distances in order to maintain existing relationships, deborah was unusual among interviewees in that she had formed long-lasting friendships with people she met initially through the use of an online marketplace. as someone living alone in later life, she was using technology designed for one purpose (financial/accommodation transactions) to initiate and facilitate face-to-face interactions with strangers from geographically distant locations, offering the potential for developing new social relationships. our next theme encapsulates the role of technology in connecting family members and groups. family relationships were frequently discussed as examples of connections that were supported by technology, through informal chatting, sharing photographs or stories and news about day-to-day life events. family connections using technology ranged from group chats to individual messages, and instant short communications as well as ongoing asynchronous conversations. whatsapp was often highlighted in this context, particularly for its usefulness in communicating with a group, and across generations. examples included whatsapp groups with interviewees, their children and partners, and grandchildren. these were sometimes longstanding groups for general communication, but at other times were set-up for a specific purpose, such as organising a birthday party. cross-generational interactions were also perceived as improving the connectedness of family members who had previously felt 'left out' of family communications. john described the example of his sister, who was previously less connected with other members of the family but could now see photographs and hear about what other members of the family were doing, without them needing to make a special effort to include her. technology was seen, in cases like this, as a solution to the barriers to instantaneous communication with family members with diverse and busy lives and routines. however, telephone calls were also important to participants as a way of keeping in touch, particularly with others who were nearer in age such as siblings or friends. in addition, paul expressed his unease at the invasive nature of commonly used apps and platforms which, for example, access lists of contacts from the device they are using or collect data to support targeted advertising. his use of whatsapp was 'reluctant' on this basis, but he acknowledged its usefulness in keeping in touch when his son was abroad, highlighting the trade-off he had to negotiate between privacy and connection. we did not ask participants explicitly about the ways in which they chose to record social interactions or events, but the use of in-built cameras in mobile phones featured in participants' accounts of the role of technology in their social lives. we have described this theme as 'capturing and sharing images'. the ease of taking photographs with a smartphone in comparison to using a camera was noted by some participants, facilitating them in documenting social occasions. moreover, despite his privacy concerns about the invasiveness of technology more generally, paul valued the fact that he was able to recover digital images from an automatic cloud backup after he accidentally deleted photos (documenting an international trip) from his mobile phone. photographs as mementos of experiences in participants' social lives, like paul's trip, were treasured. additionally, the act of sharing and receiving images was a central feature of participants' digital interactions, connecting participants with events and experiences when they were not physically present. after initially dismissing much technology (apart from facetime) as insignificant in her social life, claire later reflected that it did play a large role in how she organised and arranged social events and interactions. the theme of 'sharing information and making arrangements' draws on these organisational uses of technology described by interviewees. information was generally not necessarily shared on social networking sites or more visible platforms, but interactions commonly took place through instant messaging and other technological channels rather than solely in person. in fact, for marie, there were additional benefits to using technology as a tool for organising or making arrangements with people. she preferred the control that it gave her in contrast with the unpredictability and social awkwardness she experienced when talking on the phone. technology was mainly described by interviewees in terms of its role as a tool for connecting, or supporting connections between, people. conversely, several participants noted the ways in which technology itself was a dimension of their social life, offering an alternative to interactions with people. perhaps because of its dominant focus on portraying human lives and activities, jane felt that television was a more 'personal' type of technology. patricia and brenda watched television at times when other company or interaction was inaccessible. for patricia, this was at 'silly hours' of the day or night, whereas brenda described how she might watch television, dvds or listen to cds when she found herself alone or 'down'. there were particular times when others living in her housing development were more likely to be spending time with family, such as weekends, where she used music or television as a strategy to deal with loneliness. at the other end of the spectrum, simon tended to avoid face-to-face social activities and events with other people, preferring to spend time playing games or reading on his computer. there were two main ways that participants described technology as contributing to disconnection in terms of social interactions and events: its prevalence as a platform for information about events; and its disruptive potential during face-to-face interactions. sally used the internet but chose not to engage with social media for privacy and security reasons, but felt that this was increasingly disadvantaging her when it came to finding out about local events. she reflected on her reliance on other people to keep her informed, and the difficulties of being separate from the dominant route of information sharing via social media. for sally, information sharing was happening in a way that excluded her, meaning that she missed out on attending social activities and events that she would have chosen to go to otherwise. in contrast, liz highlighted the capacity of technology to disrupt social interactions themselves. she described both a friend's extensive use of a smartphone, and purely the presence of a phone (in use or not), as disrupting face-to-face interactions and impacting on their quality. sally's and liz's accounts indicated a reluctance to allow technology to become pervasive in everyday life, balanced against a recognition that there were places and circumstances where it could be beneficial. along with concerns about the potential for technology to disrupt relationships, the positive impacts of technology in participants' social lives were also, in some cases, accompanied by additional unwanted work. our penultimate theme, therefore, centres around experiences of technological interaction as an additional 'chore'. sally described being 'bombarded' by messages, and she and others found their perceived continual need to respond and interact electronically to be a burden. the perpetual nature of communicating using interactive technologies such as email, texts and instant messages was also unpopular with some interviewees because of the amount of time it consumed. responding was not perceived as an optional activity. even if emails contained welcome content, the task of checking, opening and reading them was viewed as a compulsory individual task and responsibility. catherine likened this to the responsibility to open letters that came through the post, rather than a choice or pleasurable activity. our final theme sums up participants' thoughts about not needing digital technologies. more traditional technologies such as the telephone or television were commonly accepted as integral to daily life. in fact, their deep-seated role in participants' social lives meant that they were often no longer considered or mentioned (by participants) when talking about technology. instead, participants tended to focus on newer digital technologies such as social media, applications and email. regarding these more modern technologies, there was a sense for some participants that they were unnecessary. for example, when talking about social media, liz explained that she did not 'think there's a gap that i need them.' christopher used the internet and email but did not consider it necessary to go online to find out about local social events as he was exposed to paper-based publicity, such as posters and flyers, as well as information via word-of-mouth. for judith, the whole idea of using a computer or the internet was superfluous when she could instead rely on her family for support, asking them for anything she needed. overall, technological connections were predominantly bridging distances, with existing local technological connections less obvious. technology was mainly seen as a tool to be used to make connecting easier where there were needs, barriers or 'gaps' (geographical or generational distances, difficulties sharing information, capturing images, avoiding uncomfortable face-to-face interactions), but not at the expense of disrupting desired face-to-face interactions or in situations where technology was seen as unnecessary (other strategies would suffice). in addition, the additional work required to use technology as an aid to connection was an unwanted consequence. willingness to use technology depended on balancing the positive and negative aspects. as described earlier, the workshop was designed to build on the findings from our interviews. an extensive list of ideas was generated through our ideation activities, which we combined and organised under themes and sub-themes. table summarises the themes and sub-themes identified in our analysis of the written workshop data. participants commented that the workshop had been enjoyable and thought-provoking-an outcome that supports us in challenging ageist stereotypes of older people as unable or unwilling to engage in creative, disruptive or wild thinking. the second theme brings together ideas that participants had for processes and actions that could play a part in promoting social interactions. these included: prioritising engagement within the wider community to develop ideas; connecting different groups with each other; improving provision of information about events and activities in the local area; connecting people with locations and activities in the city centre; and focusing particularly on making use of proximity as a tool in the process of connection. encouraging people to walk in the local area more often, and setting up hyper-local events such as street meetings, were examples of ideas to facilitate people in connecting with others living in close proximity. participants' ideas emphasise the importance and desire for strong relationships at a local level, particularly building on the existing work and connections of volunteers and groups that they were aware of. the third theme considers what types of mechanism could be used to drive change and engagement by local people, in order that involvement in supporting social connections is seen as an attractive opportunity. participants' ideas included the use of cooperative initiatives to develop or run transport services or community spaces, and incentives for small businesses to make the local area an attractive place to set up or move to. they also suggested that incentive schemes for local residents (such as loyalty cards or credits) to participate in local activities would encourage people to maintain involvement. participants proposed that making a public commitment to community work could not only increase the contributions made by individuals within the local area, but also contribute to an increased sense of community. taken together, these ideas portray a community with actively engaged members working to make positive changes, that directly and indirectly lead to individual connections being strengthened. we take forward one example sub-theme from each of these three main themes for further consideration in the second half of the discussion section of this paper, in order to begin thinking about how technology might contribute to supporting these types of initiative, as well as noting some of the challenges that would need to be addressed in designing such technologies. this paper makes a case for adjusting the design process to accommodate a bottom-up the three main themes we use to understand the workshop data are: social spaces and places; processes to promote social interactions; mechanisms to drive change. these themes capture different dimensions of participants' ideas for facilitating social interactions in the local area. ideas varied in both scale and scope (see table for examples). the first theme describes ideas that related to the physical environment and developing spaces and places to promote interactions. the proposed changes were either to directly provide locations for organised or informal activities to take place, or to change environmental factors to increase the likelihood of people meeting and connecting in their everyday lives. ideas for developing locations for activities included making better use of existing spaces as well as creating new spaces or places. residents suggested taking advantage of the large areas of green space that were nearby and using them in new ways. they also thought that new community premises, such as a community centre, would be helpful. ideas to change other environmental factors included improving the environment for pedestrians and improving security of tenure to increase the length of time that people are resident in the same location before moving home. while some ideas residents suggested were more generic, others were particularly context-specific. participants drew on their local knowledge to consider what resources in the local area could be used, and identified other resources that were lacking. table . themes from workshop data analysis. making better use of existing geographical features and spaces for social purposes, such as large areas of green space (e.g., figure ) longer opening hours e.g., library marquees/undercover spaces in parks etc., for rainy days make better use of open/green spaces for community activities e.g., exercise equipment, open a beach, more benches, ice cream vans to encourage use of parks new transport options to support travel in the immediate local area and into the city centre frequent, small scale local transport e.g., minibus every min extend the metro into the area to improve access to city focusing on proximate relationships i.e., at a street level or between those volunteering at the same events, as well as at the community level encourage greater walking in area e.g., parents taking children to school encourage volunteers to build friendships/relationships outside volunteering activities/context street level interventions e.g., street meetings/cups of tea, annual events community-driven/commissioned or cooperative initiatives around social spaces, information provision, transport and learning/training community/cooperative/volunteer-run hospitality venues buy a property on a co-operative basis and use as community resource/café/party venue community uber-style, tandems/sidecars or other forms of 'fun' transport, bike sharing, motorcycle lessons-teaching/learning/using transport cafes that also operate as training kitchen for cooking healthily, training in basic work skills by involvement in running community hub incentives to: sustain and attract small catering and hospitality businesses to the local area; encourage local people to participate in social activities increase incentives for small catering/hospitality businesses e.g., no rates/taxes for first years after opening happy hours in cafes etc., with free tea/coffee/cake, sponsored by local businesses credits for free attendance at social activities for residents e.g., swimming pool on particular days/times/a month, extra credits could be earned through volunteering dedicated time slots for social and/or physical activity/exercise time finding ways of improving the commitment and contributions of individuals to the local area to create and sustain a sense of community commitment of individuals to community e.g., minimum number of community work hours/community service and strategy to deal with those who do not contribute, volunteers to supervise weekend sporting activities for children, create sense of community between residents/students the second theme brings together ideas that participants had for processes and actions that could play a part in promoting social interactions. these included: prioritising engagement within the wider community to develop ideas; connecting different groups with each other; improving provision of information about events and activities in the local area; connecting people with locations and activities in the city centre; and focusing particularly on making use of proximity as a tool in the process of connection. encouraging people to walk in the local area more often, and setting up hyper-local events such as street meetings, were examples of ideas to facilitate people in connecting with others living in close proximity. participants' ideas emphasise the importance and desire for strong relationships at a local level, particularly building on the existing work and connections of volunteers and groups that they were aware of. the third theme considers what types of mechanism could be used to drive change and engagement by local people, in order that involvement in supporting social connections is seen as an attractive opportunity. participants' ideas included the use of cooperative initiatives to develop or run transport services or community spaces, and incentives for small businesses to make the local area an attractive place to set up or move to. they also suggested that incentive schemes for local residents (such as loyalty cards or credits) to participate in local activities would encourage people to maintain involvement. participants proposed that making a public commitment to community work could not only increase the contributions made by individuals within the local area, but also contribute to an increased sense of community. taken together, these ideas portray a community with actively engaged members working to make positive changes, that directly and indirectly lead to individual connections being strengthened. we take forward one example sub-theme from each of these three main themes for further consideration in the second half of the discussion section of this paper, in order to begin thinking about how technology might contribute to supporting these types of initiative, as well as noting some of the challenges that would need to be addressed in designing such technologies. this paper makes a case for adjusting the design process to accommodate a bottom-up component that precedes design of technological outputs. we begin our discussion of the findings from this study by considering the interview data, and their position in relation to wider debates and literature around technology and social interaction in later life. we then move on to discuss what the ideas generated by workshop participants offer in terms of implications, scope and challenges for future technology design around social connectedness, particularly when considered in the context of the interview findings. we use three sub-themes from the workshop (making better use of existing geographical places and spaces; focusing on proximate relationships; community driven/commissioned or cooperative initiatives) as examples to avoid our discussion of implications and challenges for future technology design being too generic, and to ensure that our focus remains on designing in the particular context of our research community and participants. within an age-friendly context, our analysis of interview data identifies a number of opportunities to design for increased social connectedness within local communities. participants felt that: there were few local places to socialise; they often did not know their neighbours well; there was an absence of shared community feeling; social activities on offer did not always lead to socialising or making new friends. in a policy and practice environment where technology-based initiatives are increasingly perceived as offering huge potential, our findings highlight the importance of age-friendly approaches that are grounded in the local context [ , ] . this has become even more apparent during the covid- pandemic, which has exposed the need for digital connection as an alternative to face-to-face interactions. similarly, finding new ways to connect, including with people in proximate locations, has become even more important in ways we did not anticipate when conducting this study. every community is unique, so designing to optimise social connectedness at a local level requires understanding and recognition of context-specific characteristics. in addition, taking account of the social and structural particularities of places gives insight into meanings and functions that are the result of cumulative experiences over time [ ] . in our study, the geographical layout of the community, restrictions on licensed premises and population churn were all factors that participants highlighted as playing a role in disconnection. however, these issues can also be seen as 'leverage points' where interventions could afford the greatest benefits within a specific local context [ ] . our interview data also contribute to understanding more about how older people use and perceive technology in their social lives. unlike dickinson and hill's findings in that older people did not engage with instant messaging or other forms of computer technology aside from email [ ] , participants connected using a range of methods and formations of communication. family connections using technology ranged from group chats to individual messages, and instant short communications as well as ongoing asynchronous conversations. participants were not necessarily using social networking sites to share information, as righi et al. [ ] also found, but in our study these information-sharing interactions were commonly taking place through instant messaging and other technological channels rather than solely in person. these findings reflect changing levels of digital connection for older people in the uk [ ] and emphasise the need for hci to reconsider longstanding stereotypes of older people as digitally inexperienced or uninterested [ ] . the covid- pandemic has provided further evidence to counter these outdated stereotypes, with many older people embracing technology to facilitate connections with friends and family at a time when face-to-face meetings have been restricted. yet, while participants in our study made regular use of technology to support their connections with others, this use was carefully considered. technology was not, in itself, an attractive prospect unless it was perceived to fill a 'gap' and the 'chore' of using it did not overly impact on everyday life. similarly, lindley et al. reported that older people were cautious of the time commitments required to use technologies, although they also used technology as a way to manage levels of contact and control their own availability to other people [ ] . in addition, participants in our study were aware of the potential for technology to contribute to disconnection. waycott et al. [ ] reflect that the mismatching of values and assumptions guiding a technology-based social intervention with those of the older adults participating in the evaluation, noticeably contributed to individual decisions not to participate. in an increasingly digital society, our findings again indicate the importance of design processes that are in tune with the perceptions and values of older adults. marston and van hoof draw our attention to the fact that the world health organization's age-friendly cities model does not explicitly consider the role of technology [ , ] . by adopting a lens of age-friendliness, studies like ours can ensure that methods and processes are rooted in opportunities, concerns and 'gaps' that are relevant and engaging to participants. consequently, we put forward an amended definition that highlights the need for explicit and thoughtful consideration of the role of technology in an age-friendly setting: underpinned by a commitment to respect and social inclusion, an age-friendly community is engaged in a strategic and ongoing process to facilitate active ageing by optimising the community's physical, social and digital environments and its supporting infrastructure. another contribution of our work comes from its findings about the potential for technology to contribute to building and strengthening connections in geographically-bounded communities. the combination of shared local concerns and opportunities for improving connections, combined with the knowledge that technology was infrequently used to sustain or support local connections, suggests this is a design space worth exploring. participants in this study were comfortable using digital technology to stay in touch with friends and family in geographically distant locations, particularly to maintain close family connections. kharicha et al. also found that engagement with the outside world by landline telephones and computers was an important strategy adopted by older people experiencing loneliness [ ] . for this reason, it would seem plausible that technology to facilitate local, proximate, connections and social lives would also be acceptable, should it fill perceived gaps and not lead to unacceptable levels of additional effort. the methods we used in the workshop were intended to encourage 'playful' creativity, and they were successful in their purpose of generating a wide range of ideas as well as being acceptable and enjoyable for participants. in future, we would consider adapting these methods to reduce their paper-based nature, further enhancing their potential for prompting creative thinking by participants. exploring options beyond face-to-face participation may also be important in the context of covid- and its aftermath. drawing the interview findings together with one sub-theme from each of the themes we used to organise the ideas generated by workshop participants, we suggest a number of ways in which technology might support greater face-to-face connection in local community contexts and operationalise local people's ideas. by deliberately not placing technology in the foreground in the workshop, we contend that participants' ideas (technological or otherwise) about how to tackle local issues are more likely to align with their own values and perceptions, meaning that any technological needs that arise from these suggestions will be filling 'gaps' rather than technology being introduced as the automatic interface in connection. we maintain that design processes and spaces should be context-specific and bottom-up, but summarise general implications that offer scope for further exploration and consideration in community settings. workshop participants expressed interest in re-purposing spaces in the local area that they felt were underused, or offered potential as social spaces. this ranged from using existing green spaces or buildings on a permanent or temporary basis, to creating new spaces and places for social activities and events. a real-life example of creative use of space by older people that challenges expectations and norms was the transformation (for one night only) of a nightclub in manchester, uk, into a night-time venue reserved for older people [ ] . in our study, there were suggestions that spaces could be acquired or managed by groups of local residents as cooperative initiatives. such work is ongoing in virtual spaces by older people in the uk creating a radio network [ ] . other adaptations to the built environment were also suggested by participants to improve suitability for pedestrians. however, operationalising these ideas and coordinating the input of the local community presents challenges at many levels. while online platforms to facilitate community commissioning of digital services exist [ ] , it is not immediately clear that these tools and processes would translate to local community commissioning of resources and events. moreover, it is unrealistic to expect the required intense interaction with such digital platforms, leading to the need for alternative situated means of participating and engaging in the processes. given the interest by study participants in leveraging local infrastructures and spaces, it is plausible to consider situated artefacts that would mediate between local, physical, and online engagements. for example, postervote is an innovative electronic polling system aiming to provide easy electronic voting for communities [ ] . a traditional poster is augmented with buttons that can be pressed by community members to register digital responses to questions on the poster. providing infrastructure for residents to have greater input and control over the provision of their immediate local environments would facilitate their participation in the process of age-friendliness at a community level. while our workshop focussed on connections at a local i.e., electoral ward level, some discussions were about connecting with people who were located very close nearby or even physically 'connected' by living on the same street. in fact, two participants expressed surprise on discovering that they had both been living in the area for many years a few houses apart on adjacent streets, yet they had never interacted before. concerns about safety, privacy and possible lack of interest by others were mentioned as barriers to interventions at a street level. in recent years, we have witnessed a surge in location-based and serendipitous dating/meet-up services and networks (i.e., tinder [ ] ). the core functionalities of these technologies are the abilities to discover similar individuals in your local area; privately extend an invitation to initiate a conversation; whilst maintaining a degree of privacy and safety through the network's services (not revealing personal details such as address or phone number). such solutions would have scope to support the hyper-local match-making of friendships within communities. however, our research showed that participants were not using existing online services designed to develop new relationships, indicating that these did not appeal. this is echoed by findings that older people who were lonely did not report using the internet to cultivate new friendships, despite using telephones and computers to engage with the outside world [ ] . in fact, one participant, deborah, had instead capitalised on the ability of an accommodation matching platform to facilitate face-to-face interactions in her home with strangers, who then had the potential to become friends. the opportunity for such encounters (through mutually beneficial financial, or other resource, transactions) to result in long-lasting friendships is an area for further exploration. in particular, it would be interesting to consider how these types of interaction could be translated into a purely local context, given that deborah's formation of new friendships contrasts with experiences of those in our study who attended regular local activities but did not find them conducive to making friends. the findings from our study indicate an opportunity for design around community or cooperative ways of addressing local transport gaps. a number of ideas generated by workshop participants related to improving transport in the immediate local area in order to facilitate connection to physical spaces and locations to meet other people. community or cooperative initiatives were suggested as one option, or mechanism, for driving new models of transport in the area. volunteer-run minibus and car transport did exist in the local area, but these prioritised 'essential' travel such as hospital appointments and did not have the flexibility that participants thought important. while existing schemes (e.g., streetbank [ ] -a website that facilitates possession sharing and borrowing between neighbours) have been successful in meeting other needs at a very local level, hyper-local journeys in suburban communities outside busy city centres are unlikely to offer sufficient cost/profit ratios to be attractive to existing sharing economy or peer-to-peer services such as uber. a small number of demand responsive transport (drt) schemes are running in the uk, and in theory sound promising. however, it is notable that a drt service actually operated in our study area in the past, but closed in [ , ] . similarly, existing bicycle sharing schemes rely on scale of use within large communities or cities to remain profitable, but in contrast, restricted access to a smaller population might reduce the risk of damage and loss experienced by larger scale operations. consideration of what a hyper-local transport system might look like would include questions about who might provide and use the service, and what their incentives would be. participants in this study also suggested teaching, learning and training opportunities as potentially playing a role. this is another avenue for exploration in future technology design which could serve the dual purposes of creating new connections between those learning and teaching, as well as the transport itself facilitating connections between people living in the area. our study adopted an age-friendly, bottom-up approach to explore opportunities for facilitating social connectedness for older adults in a local community context. we focused on specific community issues that could be addressed and considered the physical, social and structural mechanisms (potentially mediated or supported by technology) that might offer routes to tackling these. by understanding more about our participants' current use and perspectives on the role of technology in their social lives, we highlight a need for design work to reduce emphasis on technology as the interface between people. in contrast to previous work, we focus on connection between people in geographically close locations. we also demonstrate the importance of understanding the specific local context within which any technological interventions will take place. our findings reflect changing patterns of technology use among older adults in the uk, suggesting that adoption of new technology is acceptable when it fills gaps and does not create intrusive levels of additional work or contribute to disconnection. our modified definition of age-friendliness highlights a need for the explicit and thoughtful consideration of the role of technology. we identify topics for consideration by those seeking to design with local communities, and make the case for an age-friendly approach to designing (digital) interventions to address social connectedness in later life. world health organization. global age-friendly cities: a guide; world health organization what makes a community age-friendly: a review of international literature exploring the age-friendliness of purpose-built retirement communities: evidence from england evolving images of place in aging and 'aging-in-place how should we tackle the loneliness epidemic is loneliness a health epidemic lonely older people as a problem in society-construction in finnish media prime minister's office; office for civil society; the rt hon theresa may mp. pm commits to government-wide drive to tackle loneliness the firekeepers: aging considered as a resource never too old older voices: supporting community radio production for civic participation in later life researching age-friendly communities: stories from older people as co-investigators an age-old problem: examining the discourses of ageing in hci and strategies for future research friends or frenemies? the role of social technology in the lives of older people an investigation into the patterns of loneliness and loss in the oldest old-newcastle + study being alone in later life: loneliness, social isolation and living alone the high cost of isolation the social connectedness of older adults: a national profile the importance of social connectedness in building age-friendly communities assistive technology, computers and internet may decrease sense of isolation for homebound elderly and disabled persons ethnographic research on the experience of japanese elderly people online tales of the map of my mobile life: intergenerational computer-mediated communication between older people and fieldworkers in their early adulthood multimodal computer-mediated communication and social support among older chinese internet users desiring to be in touch in a changing communications landscape tsunagari-kan" communication: design of a new telecommunication environment and a field test with family members living apart keeping in touch: talking to older people about computers and communication older people's use of social network sites while participating in local online communities from an ethnographical perspective age-friendly cities and communities: a manifesto for change ageing in urban environments: developing 'age-friendly' cities the who global network of age-friendly cities and communities: origins, developments and challenges. in age-friendly cities and communities in international comparison interviewing for social scientists office for national statistics research interviewing: context and narrative using thematic analysis in psychology les villes amies des aînés au québec: un mouvement de changement à large échelle en faveur des aînés experiences of place and neighbourhood in later life: developing age-friendly communities not for me: older adults choosing not to participate in a social isolation intervention who doesn't think about technology when designing urban environments for older people? managing loneliness: a qualitative study of older people's views an alternative age-friendly handbook later life audio and radio network proceedings of the chi conference on human factors in computing systems good practice guide: transport and social inclusion we thank all participants who took part in this research. our appreciation also goes to cathrine degnen for her involvement in the design, planning and acquisition of funding for the study, and to drake long, meena nanduri and marlo owczarzak for their support in facilitating the workshop. the authors declare no conflict of interest. key: cord- - h rcih authors: sharififar, simintaj; jahangiri, katayoun; zareiyan, armin; khoshvaghti, amir title: factors affecting hospital response in biological disasters: a qualitative study date: - - journal: med j islam repub iran doi: . /mjiri. . sha: doc_id: cord_uid: h rcih background: the fatal pandemics of infectious diseases and the possibility of using microorganisms as biological weapons are both rising worldwide. hospitals are vital organizations in response to biological disasters and have a crucial role in the treatment of patients. despite the advances in studies about hospital planning and performance during crises, there are no internationally accepted standards for hospital preparedness and disaster response. thus, this study was designed to explain the effective factors in hospital performance during biological disasters. methods: qualitative content analysis with conventional approach was used in the present study. the setting was ministry of health and related hospitals, and other relevant ministries responsible at the time of biologic events in islamic republic of iran (ir of iran) in . participants were experts, experienced individuals providing service in the field of biological disaster planning and response, policymakers in the ministry of health, and other related organizations and authorities responsible for the accreditation of hospitals in ir of iran. data were collected using semi-structured interviews in persian language. analysis was performed according to graneheim method. results: after analyzing interviews, extraction resulted in common codes, subcategories, and categories, which are as follow: detection; treatment and infection control; coordination, resources; training and exercises; communication and information system; construction; and planning and assessment. conclusion: hospital management in outbreaks of infectious diseases (intentional or unintentional) is complex and requires different actions than during natural disasters. in such disasters, readiness to respond and appropriate action is a multifaceted operation. in ir of iran, there have been few researches in the field of hospital preparation in biologic events, and the possibility of standardized assessment has be reduced due to lack of key skills in confronting biological events. it is hoped that the aggregated factors in the groups of this study can evaluate hospital performance more coherently. the deadly pandemics of infectious diseases are rising worldwide. in the twentieth century, have caused death of more than million people in many parts of the world ( ) . in the last relatively mild h n pandemic in , - of people were killed who were not necessarily in high-risk groups ( ) . according to the report of www.warontherocks.com, about cbrn events were reported between and ( ) . also, the possibility of using microorganisms as biological weapons is a real and increasing probability all around the world ( , ) . increasing the tendency to use biological weapons due to increased terrorist attacks, their relative convenience use, and low cost have led to many health concerns ( , ) . between and , - persons were killed in major terrorist incidents nearly every months ( ). hospitals are vital organizations during biological disasters and play a crucial role as a place of care and treatment for such patients ( , , ) . hospitals should have an essential role in biological disasters ( ) ( ) ( ) ( ) . having specialists and staff with knowledge and skills relevant to biological events can play a significant role in reducing mortality and morbidity in the community, especially in the first few hours, which is called the golden time. the result is hospital preparedness to deal with biological events, which improves the response rate and accelerates the process of rehabilitation ( ) . hospital services are differentiated from other institutions by their types of activities, resources, staff, multiple specializations, and equipment used ( ) . the response of hospitals has a multidimensional function (approach) ( , ) . despite the advances in studies about hospital planning and performance during crises, there are no internationally accepted standards for hospital preparedness and disaster response ( ) . to date, there has been no valid methodology for assessing the preparedness of hospitals for disasters ( ) . however, after the onset of disasters, it is necessary that hospitals be prepared to deal with the new circumstance and surge capacity ( , ) . disaster preparedness is recognized as one of the top priorities in the medical field ( ) . this process varies in cbrn events ( ) . according to the recommendation in the process of planning, preparing, and responding to disasters in the health system, it is necessary to use the "all-hazards" approach ( ) . however, in practice, this approach does not seem to be suitable for man-made and technologic disasters such as biological, chemical, or nuclear events. nevertheless, evaluating hospitals' performance during crises, especially the one caused by biological disasters (eg, the epidemic of diseases whether natural or intentional), is a topic that has been dealt with inadequately. since in the face of disasters and biological threats different conditions prevail in hospitals, thus, evaluating the performance of hospitals in such situations requires a different mechanism. in addition, no comprehensive plan has been developed to manage biological events in iran. therefore, the present study was conducted to identify factors affecting hospital response in biological disasters. qualitative content analysis with conventional approach was used in this study. the qualitative content analysis approach was used for subjective interpretations of text data by systematic classification process, coding, identifying categories, or patterns. using this approach, the researcher avoids classification with background thoughts and allows categories formation during the research process ( ) ( ) ( ) . hospitals under the supervision of ministry of health and other relevant ministries responding to biologic events in ir of iran at (including the defense ministry) were included in this study. participants in this project were experts, experienced individuals providing services in the field of biological disaster planning and response, policymakers in ministry of health, and other related organizations and authorities responsible for the accreditation of hospitals in ir of iran. data were collected through conducting semi-structured interviews in persian language with the aim of explaining factors affecting the performance of hospitals in response to biologic threats. initially, the researcher met each participant and presented the research goals and obtained their consent for participation. three participants did not respond to the request and introduced another person as an expert in the field of research. two participants stated that these questions were not in their field of expertise. a total of interviews were done. the age range of the participants was - years. the purpose of the interviews was to explain and explore the factors influencing hospital performance in response to biologic threats. interviews began with simple and general topics and went on to specific questions. some questions were changed during the research (after completing the third interview and analyzing the data). types of questions were as follow: open questions, based on the default, and case-by-case. some of the interview questions were as follow: . what are the effective factors in assessing hospital performance at the time of biological events? . what are the management problems that you have experienced or may experience during a biological threat? . what are the strengths and weaknesses in assessing a hospital's performance of biological threats? . what is the difference between assessing the performance of hospitals in natural disasters and in biological distasters? during the interview, the researcher observed and noted the participants' interactions with the environment and their reactions, which were considered in the data analysis. the number of participants was determined based on the saturation of the obtained codes, so that the new codes were not extracted by new interviews. sampling was done using purposeful and snowball method. the interview took about - minutes. at first, interviews were conducted with the participants, their voice was recorded, and transcription was done a short while after each interview. data analysis began after the first transcription. to analyze the data, the researcher studied the data deeply, reread, and considered the text of the interview, gained understanding of the data, and finally completed the analysis ( ) . after each interview, transcription was done and field observations notes were reviewed several times. the final text was approved by each participant (member check). after the third interview, the questions were redesigned. in this study, interviews and field notes were the analysis units. the texts were divided into content areas and meaning units. meaning units were summarized and codes were extracted. multiple codes were compared with each other in terms of differences and similarities; then, categories and subcategories were formed. the extracted categories were discussed by scholars; finally, the basic and essential meanings of the categories were edited. data collection continued until saturation was reached for each concept. in a qualitative research, rigor shows concepts of credibility, dependability, transferability, and different dimensions of trustworthiness ( ) . to achieve maximum credibility, the research team used a range of expert participants. participants were among authorities of health in ir of iran, officials and staff of biologic laboratories, and some experienced officials from civil and military organizations with a history of managing infectious disasters. after each interview, transcription of texts was performed in a short interval. interviews were listened repeatedly, and the researcher extracted the meaning units. then, based on the condensation and abstracting of meaning units, the codes were extracted. similar codes were placed in subcategories, and the categories were formed according to the similarities and differences between subcategories. in the case of extraction of codes, subcategories, and categories, expert opinions were taken from the research team, and agreement was reached among researchers, experts, and participants about the differences. this study has been conducted in the context of ir of iran. according to researchers' view, the results can be generalized to other countries, but the choice has been left to readers ( ) . this study was approved by the national committee of ethics of ir of iran (code number: ir.sbmu.retech. rec. . ). all participants were aware of the research objectives. informed consent was taken from all participants and their participation was kept confidential. all interviews were recorded with participants' permission and were fully transcribed within a short period after the interview. analysis was done simultaneously. the demographic characteristics of the participants are presented in table . participants answered all the questions during the interview. after analyzing interviews, codes were extracted. codes were categorized in subcategories after analysis. according to the similarities and differences in nature of subcategories, categories were extracted: detection; treatment and infection control; coordination; resources; training and exercises; communication and information system; construction; and planning and assessment. the graphic diagram of the extracted categories and subcategories is shown in figure . table contains extracted categories, subcategories, and common codes by content analysis. after analyzing the data, it was found that all participants considered the ability to detect biologic outbreaks or emergencies in hospitals as an effective factor in hospital performance. the first step in controlling a biologic emergency is to detect the event in a hospital. the subcategories of determining the type of event (intentional or unintentional) and early detection were extracted. - : according to the participants, the delay in diagnosis with subsequent possibility of developing outbreaks of communicable diseases could be a major factor in hospital performance. one of the participants (p ) mentioned, "rapid detection is an important factor in proper performance in biological disasters. in the crimean-congo fever epidemic, if diagnosis was not established on time, the disease would have spread further". - : determining the deliberate or unintentional cause of a biological event can affect hospital performance. in intentional events, the biologic agent may still exist in the environment which will cause the disaster to be continued. another participant (p ) said, "it is difficult to diagnose the cause of deliberate biological events because there is less experience about it. treatment has been discussed on the textbooks, but the bioterrorism detection has not reviewed extensively, and it is very difficult". from the participants' perspective, the ability to treat and control the infection in the hospital was considered as an important factor in the proper hospital performance in biological disasters. the obtained subcategories were as follow: the ability to manage the biologic event and treat patients; the ability to care for the patients; the ability to decontaminate the injured people and surfaces; the ability to perform biologic triage; and pre and post exposure prophylaxis in affected individuals. - : drug therapy of patients and pre and post exposure prophylaxis: the extracted common codes according to participants' interviews were possibility of appropriate response after a biological event in a hospital, prompt and suitable treatment of the patients, having an efficient team of rapid response, the ability to discharge if necessary, pharmaceuticals prescription, having adequate stockpiles, and the ability to perform pre and post exposure prophylaxis. one participant (p ) said, "if prevention is not imminent with different medications and appropriate vaccines, the disease would spread. for example, if respiratory anthrax or plague becomes prevalent, vaccination and appropriate therapeutic prophylaxis are the only way to prevent the disease progress in the community". - : nursing: the presence of skilled and capable nurses was one of the subcategories obtained in this study. nurses who are trained, skilled, and familiar with personal protective equipment may have positive effects on hospital performance. one of the participants (p ) mentioned: "having skilled nurses to care for infectious patients is valuable as patients' treatment in epidemics. one day i went to the hospital for a visit and saw the aids patient wearing a mask. the head-nurse had told him to do so". - : isolation: according to the participants, the ability to isolate patients with communicable diseases in the hospital and in the designated sites for group isolation was an important component of infection control. one participant (p ) said, "isolation spaces are needed based on the causative agent (such as droplet or airborne isolation). in emergency situations, metal partitioning is better, and if not possible, minimal isolation should be executed even with curtains". - decontamination: most participants considered the ability to decontaminate victims efficiently as one of the important factors in hospital performance dealing with biological disasters, which is an important step in decontaminating patients, surfaces, and equipment in proper response to such disasters. one of the participants (p ) stated, "environmental health authorities should be active in tackling the issue. notifications should be declared as soon as possible. environmental decontamination is needed for each disease". - : triage: according to participants, the use of specialized triage in biological events affecting many victims will enhance hospital performance. biological triage which has a different mechanism than other triage systems helps to reduce infection transmission and provide high-speed treatment for people with high-priority care. it also provides the most services in the least amount of time to the largest number of victims. one participant (p ) said, "all hospitals should have a triage system and special checklists." biological triage is necessary. there are no triage systems for infectious diseases in my hospital, so there is not any sorting during an outbreak". - : infection control: participants considered infection control as an essential criterion for hospital performance in biological disasters. the common codes derived from these subcategories are as follow: the ability to control infections during deliberate or natural biological outbreaks; the availability of preventive drugs at a predetermined time during an epidemic of communicable diseases; appropriate vaccination of people at risk; and the safety of hospitalized or outpatients patients in the outbreak of infectious diseases; and waste management. one participant (p ) stated, "to see how a hospital performs, we need to see how much patient's safety is considered. sometimes, with a simple maneuver such as washing hand, transmission of the infection would be prevented". participants considered inter-sectoral and intra-sectoral coordination as an important factor in the proper hospital performance during biological disasters. - : intra-sectorial coordination: a common subcategory was coordination and collaboration within the hospital during a biological disaster, including predetermined inter-organizational tasks. one participant (p ) said, "when epidemics occur, it is highly important that internal parts of the hospital (such as laboratory, radiology, emergency departments, and others) be coordinated. in the early days of influenza epidemic, we did not know where to send the patients' samples for definite diagnosis, which made the process more complicated". - : inter-sectorial coordination: the common codes in this subcategory were as follow: existence of memoranda between hospitals and partner centers (such as organizations for corpses burial, drug production companies, vaccines and personal protective equipment producers, reference laboratories, buildings' owners that can be used for mass storage or isolation). one of the participants (p ) stated, "if there is a suspicious anthrax case and the hospital is a regional one, they should know which laboratory would help, and there should be an accepted guideline for referral". according to participants' viewpoint, the availability of appropriate human resources, necessary equipment, appropriate physical structure, and enough funding has a beneficial effect on hospital performance in biological disasters. these subcategories created the category of resources. - : human resources: according to the participants' perspective, one of the most important factors affecting hospital performance was the availability of human resources in biological emergencies in terms of quality and quantity. defining an organized structure of the staff for the response, duty description for the team, the right staff, and an efficient manager in the hospital seemed necessary at the time of biological disasters. one participant (p ) said, "sometimes we have cases of flu, meningitis, and tuberculosis, but the hospital performance is not appropriate and practical. although training was provided and relative preparedness was expected, during the swine flu outbreak, all staff were afraid and wore masks in hospitals. even the staff in the infectious diseases ward wore masks, which was not necessary and only caused horror. only those who are within a meter of the patient should wear a mask". . : physical structure: based on participants' viewpoint, appropriate physical structure of hospitals to respond to biological disasters is an effective factor in dealing with biological disasters. the proper physical structure of a hospital, enough space for biologic triage, suitable isolation space considering the type of agent, a proper radiology and laboratory structure, and a standard lab were effective subcategories of this category. one participant (p ) said, "one of the performance evaluation factors is whether the hospital has been standardized; having a triage space and decontamination room before entering to the main ward and isolation from the emergency department are highly important. in the influenza epidemic, all hospitals were ordered to separate the patients upon arrival at hospitals, but this was not possible in some hospitals". - : equipment: the subcategories were equipping some ambulances ready for a biologic event, having special and practical equipment when dealing with biological disasters, adequate personal protective equipment, and the ability to maintain laboratory biosafety. one participant (p ) recommended, "having enough equipment to be able to provide good biosecurity is of significant importance. there is not a special stretcher for contagious patients in our hospital, and the lack of a special stretcher for carrying infected patients can impair performance". - : budget: according to the participants' opinion, allocation of appropriate budget for hospital was an effective factor in assessing the hospital performance during biological disasters. insurance of staff and the hospital, and proper allocation of funds were the common subcategories of this category. one of the participants (p ) said, "my hospital manager is concerned about the financial aspect, and he has limitations on training and recruiting human resources. we do not have financial resource even for equipment and training, and our managers do not believe in spending money for managing these disasters. they prefer to deal with tangible issues rather than intangible issues such as biological disasters that have not yet happened". training and exercise influence hospital performance. the subcategories were appropriate educational content in accordance with the up-to-date changes in the field and intermittent exercises. - : educational content: the following subcategories were extracted: having rich and up-to-date educational content with emphasis on biological group a & b agents; providing training on how to use personal protective and prevention equipment, triage, isolation, secure area, control, and treatment; and providing training for misbelief correction. one of the participants (p ) said, "there should be an educational content related to the subject; it can be a part of hospital accreditation. some employees even do not know the correct pronunciation of diseases". - : training: all participants considered staff training as one of the most important factors in hospital performance. the extracted subcategory was receive training in the field of biological agents, including continued and regular education, up-to-date training, and training about preventive and personal protective equipment (mask types and time), isolation types, triage, secure area, and group a & b agents. one participant (p ) recommended, "up-to-date training should be available for staff with an interval of maximum of up to year. our personnel have been graduated many years ago, and their training has not been updated at all". - : exercise: by analyzing the data, intermittent and proportional exercises were obtained as common codes in the exercise subcategory. according to participants, the factors of this subcategory included the need to conduct a biological exercise in the hospital, and presence of a range of exercises such as top table exercise for managers and coordinators and other types of exercises, and execution of intermittent drills within a specified time schedule. one of the participants (p ) declared, "our managers did not have any experience in biological disaster management, even in the form of a drill. we should exercise and learn what we lack". another participant (p ) said, "there should be an exercise index for evaluation (drills about personal protective equipment) ". according to the results of the data analysis, the risk communication system, information security, risk understanding, and surveillance system were subcategories of the communication and information system category. - : risk communication systems: having a risk communication system, information security, risk understanding, and a surveillance system were determined as subcategories of this category. - : information security: information security is important in an outbreak of infectious diseases in hospitals, as non-patients may go to the hospital for fear of panic or patients may not come to the hospital for fear of stigma. the common codes were as follow: the possibility of sending written reports or internal automation to senior officials, laboratories, and the ministry of health, and lack of public notification in some instances. one of the participants (p ) said, "a false outbreak would occur without proper communication with the economic authorities. each time after a rumor about an infectious disease, many will come to hospitals as false patients, and controlling such situations would be very difficult". - : risk understanding: this subcategory was also derived from the information and communication category. participants believed that developing a positive attitude towards the possibility of biological disasters in hospital managers is crucial, because if a manager or staff does not believe in the possibility of biological disasters, there would be no possibility of necessary and timely action. one participant (p ) declared, "hospital managers do not have a proper attitude about this kind of problems. even after being trained by senior officials, they still do not have a good perception of the biologic disasters". - : surveillance system: according to participants, the use of surveillance systems in hospitals and the active registration of infectious diseases were considered as effective factors in hospital performance. one participant (p ) said, "the center for diseases control of ministry of health has a tradition of its own. in the health sector, they have a disease expert who will inform you if something happens. they themselves do not actively seek out any disease". the existence of an appropriate hospital incident command system (hics) for biological events was one of the main obtained categories in this study. extracted categories were the need for existence of a code for the biological crisis, type of system activation, existence of a unique command, use of qualified advisors in a commanding system, and proper organization of the staff. one of the participants (p ) announced, "having an incident command plan during a biological disaster is highly important. commanding systems do not work well in our hospitals in important and dangerous disasters such as earthquake and floods". planning and assessment were among the other key elements that influenced hospital performance during emergencies. risk assessment in hospitals was identified as a basic point in evaluation of hospitals. in the absence of a risk assessment in a hospital, finding priorities for risk reduction measures can lead to resources loss and parallel work. participants considered the factors that impacted hospital performance: the existence of qualified self-assessment mechanisms along with appropriate indicators in assessment checklist and a well-defined cutoff point. extracted subcategories were existence of updated instructions and guidelines, a special response and recovery plan for biologic threats, using the all-hazards approach to preparedness, and a lab plan. another participant (p ) said, "readiness assessment checklist must be completed every - months for each center. our hospitals do not have any assessment checklist for infectious diseases". in this qualitative study, which was done using content analysis, the effective factors for hospital performance in biological emergencies in ir of iran were identified as follow: diagnosis; treatment and control of infection; resources; coordination; training and practice; communication and information systems; construction; and planning and assessment. detecting a biologic event is one of the primary influencing factors in hospital performance. early diagnosis is one of the important factors for initiating immediate action and response to prevent further development of a biological agent ( ) . controlling hospital outbreaks requires rapid diagnosis and search for clusters; then, appropriate controls are executed ( ) . early diagnosis of the disease prevents its spread and can be effective in the timely treatment of exposed individuals and doing biologic triage. while an epidemic is rapidly discovered, its spread can be prevented by isolating patients and prompt prophylaxis. also, recognizing the type of biological disaster (intentional or unintentional) aspect may have an impact on hospital function because management of such biological emergencies may en-counter many complications considering type of agent, genomic manipulation, event location, geological and climatic conditions, and disease spread in the community prior to definitive diagnosis ( ) . over the past decades, the intentional enhancement of using biological agents has increased the demand for risk assessment and monitoring of such events, which often involves modeling approaches based on certain assumptions such as the ability to generate, store, and distribute. the ability to release a biological agent as a weapon does not only result in the creation of airborne transmissible microorganisms but can be transmitted from human to human and spread. management of deliberate transmissible is different from that of non-transmissible epidemics ( ) . another effective factor in hospital performance in biological events is treatment and infection control. in a biologic emergency, treatment measures and timely response to the event are important factors. triage is an important factor in controlling hospital infection during a biological emergency ( ) . most triage systems deal with traumatic or kinetic injuries ( ) . such systems are not applicable to other types of disasters, including biologic emergencies, because some factors (eg, exposure and symptoms) do not affect the infection control and make rapid diagnosis and treatment more difficult. victims are unlikely to be harmed, and there may not be a particular scene of disaster ( ) . therefore, it is necessary to consider a special system of triage instead of conventional systems ( ) . in accordance with burkle's recommended method, biologic triage is used for patients in an incident with a large number of injured people and divides them into groups: ( ) susceptible but not exposed; ( ) exposed but not yet infectious; ( ) infectious; ( ) removed by death or recovery; and ( ) protected by vaccination or prophylactic medication ( ) . in settings where infectious diseases are easily transmitted, deaths from infectious diseases are more likely than traumatic events ( ) . therefore, applying biologic triage is vital for controlling transmission. during biologic emergencies, triage makes it easier to control and treat the patients, prevents loss of resources, and reduces the probability of transmission of communicable diseases, and decreases the burden of hospitalization by reducing the number of visits to hospitals ( , ) . in this regard, access to drug and vaccine supplies and appropriate measures can reduce the number of patients or decrease the disease severity. effective actions in performance are hand washing and self-protection methods for staff, and proper isolation based on the type of disease ( , ) . providing care for patients within the hospital is an important part of patients' treatment and infection control at treatment centers ( ) . therefore, having competent nurses and trained infection control specialists as well as self-protection methods are other measures related to performance improvement ( ) ( ) ( ) ( ) ( ) . in biologic emergencies, one means of differentiation with other common emergencies is the need for self-protection methods of staff, especially physicians and nurses who have close contact with the patients ( , priate measures stops the transmission of the infection between patients and staff, including nurses ( , , , ( ) ( ) ( ) ( ) ( ) ( ) . decontamination spaces of biological patients will make these disasters distinct from others. decontamination is less important in disasters with large number of traumatic patients, but in biological disasters (especially man-made), the entry of noncontaminated patients into hospitals and the implementation of individualized and collective quarantine are of great importance ( , , ) . risk management approaches for infectious disasters are necessary to reduce the risk of secondary contamination with regards to decontamination measures and surveillance ( ) . based on the results of this study, human and financial resources, physical structures of hospitals, and equipment (including personal protective equipment, laboratory, appropriate vaccine, and antibiotics) are effective factors in the proper functioning of hospitals. these findings were consistent with those of other studies ( , ( ) ( ) ( ) ( ) . an appropriate response requires access to laboratory facilities ( ) . decontamination facilities and access to personal protective equipment for triage and decontamination teams are among the limitations of performance in biological events ( , , ) . adequate budget is usually not allocated due to the high cost of preparedness and performance measures in infectious disasters. several studies have shown that the number of public health staff may decrease at the time of biological disasters (such as flu pandemics) ( ) ( ) ( ) . typically, volunteers will meet the required human resources (efficient and trained personnel) in disasters ( , ) ; however, this would not be the case in biological disasters. although the amount of motivation to work during biological disasters varies from country to country, the total amount of motivation is lower than in other events ( , ) . this drop in staff motivation is also evident in the number of volunteers ( ) . however, more research is needed to study the willingness of public health staff in disasters ( ) . therefore, one of the most important factors in biological disasters is the provision and management of manpower required in hospitals. previous studies have shown that male gender, being a physician, having a full-time job, self-protection, and communication equipment for staff, and basic needs such as water have a positive impact on the willingness to work in such events ( , , ) . motivation facilitators for working in infectious emergencies include access to vaccination and personal protective equipment, flexible work shift, taking care of staff children, and information sharing ( ) . regarding the release of a biologic agent, the strategic storage of the vaccines as well as pharmaceuticals for treatment of the agent can be important because easy access to antibiotics and vaccines is very effective. access to ventilators for the management of infectious respiratory disasters is a necessity ( , ) . there are currently antiviral drug storages for responding epidemics that cost a lot ( ) . the lack of funding and financial resources is a major obstacle to the preparedness and proper performance in infectious disasters ( , ) . appropriate supply strategies, adaptation to the severity of the event, and the type of microorganism have a preventive and controlling role in infection from person to person ( , ) . also, having a proper physical structure to respond to biological events is important for proper functioning. this factor has been mentioned in numerous articles ( ) ( ) ( ) ( ) . examples which may be presented here are the existence of a separate entrance door for the emergency department, proper design of the rooms and the hospital, and proper equipment (eg, separate ventilators in the emergency department) ( ) . based on the findings of this study, staff training was one of the main elements of the proper functioning of hospitals in biological events. reviewing articles also indicated that education and training are key elements in disaster preparedness ( , ) . many efforts have been made to explain the capabilities and design of training curricula for management and response to cbrne events, but there is still lack of capability-based plans ( ). emergency department physicians, nurses, and support staff are the main groups for training and education. hospitals will not be able to respond appropriately in disasters without the upgraded educational guides ( ) . training is an important challenge in managing disasters which was obvious in events such as ebola outbreak. control of communicable diseases such as ebola and other infections may be affected by lack of educational materials, curricula (educational curriculum, development of educational contents, training resources, and tools), and educational contents ( ) . most of training courses (during and after ebola epidemic) have been performed for infection control staff and has not been addressed for other stakeholders ( ) . best practices for ebola education are engaging all stakeholders (eg, crisis managers, infectious disease control staff, and health workers) in educational programs. the most important educational challenges are annual budget and misdeclaration of sufficient training in an organization ( , ) . sustained education for combating the spread of infectious diseases requires annual budget, full support of the organization management, and engaging all stakeholders ( ) . the reports show poor knowledge about disaster planning and biological events in emergency departments around the world ( , , ) . it is imperative to ensure full recognition of risk reduction plans in infectious disasters for all those responsible for reducing the risk. in an egyptian study, medical residents had less training on personal protective equipment than specialists and counselors ( ) . however, education in this regard is one of the key points in infection transmission and control. occupational and non-occupational stresses in physicians were more than nurses, indicating the need for further training on the nature of pandemics, the results, complications, and methods of infection prevention ( , ) . in the absence of comprehensive support and failure to address the motivation or needs of professionals, effective education and the use of educational opportunities would be a challenge ( ) . developing educational standards and guidelines for a medical response to disasters (especially cbrn) has a major impact on emergency response to disasters ( content, determining the type of training, and evaluation of tools. a review article of cbrne training courses between - indicated that course evaluation was not done by any study ( ) . essential elements of education are personal protective training, hospital incident commanding systems for emergencies, surge capacity, and assessment and risk determination in accordance with biological disasters ( ) . coordination is one of the disaster management requirements in communities and hospitals. disaster management occurs in a complex context. this complexity is the result of a variety of different functions of the external and internal sectors in a hospital. coordination of these sectors would result in proper disaster management. in this study, internal and external coordination were key factors in response to biologic disasters. the presence of the emergency coordinator promotes health sector preparation activities. coordinators also provide a road map for moving in and out of hospital-crisis-related factors. avery et al indicated that the presence of a coordinator increases the level of readiness in the health sector in a disaster ( ) . this is evident especially in infectious disasters which require more coordination between infectious disease control centers and security sectors. jones et al showed that the coordinator had a direct relationship with the readiness of hospitals in pandemics. the connection was not linked to readiness in other settings such as casualty incidents, general preparedness of the hospital, and inefficiency of the hospital infrastructure. this could be a sign of the difference in infectious disasters. management requirements of such events include provision of vaccines, drugs, and personal protective equipment, and sufficient equipment and personnel resources at local, national, and international levels. memoranda of agreements (moas), memoranda of understanding (mous), and planning partnerships with other hospitals, health centers, government, local authorities, and other providers of support services are examples of out of organization coordination ( ) . capability of hospital external evacuation also requires external organization coordination, which according to the review of articles in the field of interhospital memoranda, has the lowest rate for children and infants ( ) . risk communication is one of the central components of proper performance of hospitals during infectious disasters ( ) . communications and information systems were derived as one of the main categories in this study. when an outbreak occurs and general public health is compromised, direct interventions and treatment options may be limited due to lack of time and the need for resources. therefore, communication, notification, and guidance are often the most important tools of public health in risk management during such events ( ) . communication readiness reduces the response time of the crisis ( ) . other impacts of communication and information systems during disasters are confidence of people in managers and acceptance of protective behaviors, disease surveillance, and reduction of confusion ( ) . to effectively respond, information should be organized in a timely fashion and be disseminated through multiple channels along with appropriate training ( ) . health communication includes key elements: message, receiver, source of information, and the channel for information exchange. the above elements should exist and function properly in any health-related communication plan. communication would be implemented in the field of informing the public as well as in health systems, especially with respect to infectious disasters ( ) . public health stakeholders, although not directly involved in public health emergency management, will take timely decisions, plan, and control timely access to information ( ) . moreover, to effectively implement communication in these disasters, standardized educational content, clear national guidelines, and pre-prepared plans in the field of communication in hospitals are required ( ) . ineffective communication is one of the potential reasons for the failure of infection control in health workers ( ) . hospital communications should be completely clear, scientific, and understandable. health workers are an important criterion for community's trust in resources and their knowledge and dealing with the situation will affect the trust of the community ( ). bonneux et al suggest that the management of unpredictable panic of hospital staff is more difficult than controlling the spread of disease ( ) . the clear release of information can prevent the fear of staff and society ( ) , and a long negative impact will occur with no on time intervention on hospital performance ( ) . understanding the proper risk from leading risk is a decisive factor in disaster management. today, in a world where the information transfer (whether right or wrong) is done at a rapid pace, the perception of risk from truly risky cases is less than estimated, and the risk of rare cases is overestimated ( ) . understanding the risk is related to the mental sensation of control. the threat of an epidemic may in part be frightening because of feeling lack of control that leads to an unwanted activity ( ) . verbal communication and standard communications (eg, guidelines, education, electronic communications, and marketing) are definitive communication pathways in infectious disasters. experiences indicate that traditional methods are unsuccessful in changing and maintaining the best performance in infection control, although newer methods (such as electronic communications and marketing) have some problems. some approaches (eg, involving health staff in the communication processes or up-down communication) can improve communication methods ( ) . the timely identification of cases of infectious diseases with increased patients over a given period of time is a critical necessity for the ipcs. survival systems in hospitals are currently focusing on a small set of microorganisms such as methicillin-resistant staphylococcus aureus, carbapenem-resistant enterobacteriaceae, and clostridium difficile ( ) . there are several pathways for the transmission of pathogens (staff to patient, environment to patient, patient to patient, visitors to patient, etc.) due to dynamic health care in hospitals. better monitoring of the epidemics onset would be implemented by operating the modern and multifunctional surveillance systems, including observing symptom reports in specific time spots, syndromic surveillance systems, prediagnosis and nonspecific criteria monitoring, and health behaviors observation (eg, absenteeism from work or school, pharmacy referral or even search rate in search engines with specific words that indicate an increase in the incidence of infectious diseases) ( ) . although more modern systems such as electronic surveillance systems have high sensitivity, their positive predictive value is low ( ) . united states has conducted surveillance systems and epidemiological surveillance with a large budget in the framework of biowatch program to monitor the deliberate propagation of biological agents ( ) . in this study, an incident management commanding structure in accordance with biological emergencies was found to be the proper structure of the main element of performance. hospital incident command systems are used as a model for disaster response in some countries. this system is an attempt for standard performance of hospitals in disasters ( , ) . in recent years, incident command system has been implemented for iranian hospitals to manage disasters with an all-hazards approach ( ) . application of this system is part of the requirements for the accreditation of hospitals in ir of iran. however, this system has limitations such as not addressing the vulnerability of hospitals and not assessing the hospital performance in disasters ( ) . the participants considered the incident command system (consistent with biological events) as an effective element of hospital performance in biological events. use of the incident command system is part of an appropriate response to cbrn events ( , ) . the hospital incident commanding system is an integrated structure that despite the volume and effects of the events can provide coordination, control, operations, planning, support, and other necessary functions for event management, if properly implemented. it also explains responsibilities clearly leading to appropriate response ( ) . the effectiveness of this system has been indicated in outbreaks of infectious diseases ( , ) . if the response to biological emergencies will be designed as a systematic approach, it would lead to faster response by establishing coordination, speed of communication, recalling staff, etc. ( ) . this adaptation could include selection of specialized infectious and epidemiologic consultants, proper planning, operations based on infection control requirements, treatment and care, and other requirements for managing biological crises. in addition, matching these systems with biological emergencies can speed up the response by increasing external and intra-organizational coordination of multiagent organs ( ) . planning was one of our extracted main categories. the existence of disaster management plans in hospitals is essential to ensure preparedness and response, even before the emergence of events. a disaster management plan is a set of procedures, policies, interactional patterns, roles, and contingencies which are developed to prepare and implement appropriate response to a crisis ( ) . this plan includes staff training plans, responding to potential biologic agents, pollution prevention, rapid communication plans, potential quarantine exposure (individual and group), resource production and planning, and rapid diagnostic plans ( , ) . the existence of evidence-based guidelines is one of the deficiencies in infection control in iranian hospitals. self-assessment, external evaluation, and the use of intra-organizational and external experts for scientific review of guidelines and plans can have a positive effect on improving hospital performance. however, performance evaluation can be assessed in real terms after disasters and from lessons learned ( ) . security issues affecting the health and national systems and context of intentional biologic events were limitations of the present study, which did not allow all selected managers to participate in the study. however, the limitation was resolved by continuing the interviews with the main managers, determining the alternative ones, and continuing the interviews until saturation. hospital management in outbreaks of infectious diseases (intentional or unintentional) is complex and requires different planning than natural disasters such as earthquakes, floods, etc. in such disasters, readiness to respond and appropriate action is a multifaceted operation that has not been addressed in ir of iran and other countries so far. in this study, the factors affecting performance in such events were qualitatively explained and categorized. also, to properly perform in such disasters, each of the categories and their subcategories should be carefully implemented with detail. developing a model for assessing hospitals' performance in biological 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multiagency response to a legionnaires' disease cluster in sydney sars and the hospital emergency incident command system (heics): outbreak management as the mother of invention we would like to thank all of participants who spent their valuable time for interviews and other surveys. all authors disclose that there is not any actual or potential conflict of interest, including any financial, personal, or other relationships with relevant authorities or organizations within years of starting the study. key: cord- - gnmxbk authors: elayeh, eman; aleidi, shereen m.; ya’acoub, rawan; haddadin, randa n. title: before and after case reporting: a comparison of the knowledge, attitude and practices of the jordanian population towards covid- date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: gnmxbk coronavirus disease- (covid- ) is an emerging contagious infectious disease. it is pandemic and has affected more than million people and resulted in more than , deaths worldwide (https://www.worldometers.info/coronavirus/#countries; / / ). our research group initiated a study to ascertain the knowledge, attitude and practices (kap) of jordanians toward covid- prior to any initial case report in jordan. this project was underway when the first jordanian case was reported. we extended our study to identify how case reporting would alter public kap towards covid- . this cross-sectional study randomly selected and recruited jordanian adults. a four-section questionnaire was devised to address the sociodemographic characteristics of the subjects and their kap toward covid- . the mean knowledge score for the study population was . ± . (out of the knowledge questions), with . % of the participants having good knowledge about covid- . participants’ practices to prevent transmission of covid- were adequate in more than % of participants. most participants had positive attitudes regarding their role in preventing covid- and many of the participants’ attitudes and practices changed to more appropriate ones after reporting the first case of covid- in jordan. the percentage of participants who trust the government in confronting covid- increased significantly (p value < . ). however, one alarming and unexpected finding was that the prevention practice score of participants working in the medical field was similar to those from the general population. this may necessitate stricter training and guidelines for this group who will be in the frontline in combating the disease. impact of this study: the data generated from this study shows that when cases of disease were reported, the public’s attitudes and practices improved in many aspects, and that confidence in the government to contain the disease was boosted. we believe that this study is important in allowing other, international governments to develop an understanding of public kap during pandemic disease outbreaks. a a a a a after reporting cases which were all isolated in dedicated hospitals, the jordanian government applied a nationwide lockdown and activated the defense law, which allows the army and police to ensure the adherence of public to the curfew [ ] . under these circumstances, where public health is threatened by the pandemic and since the people's attitudes and practices play a crucial role in limiting or spreading the disease in their community, evaluating the knowledge, attitude, and practice (kap) of the general public towards the covid- is crucial. therefore, the initial aim of this study was to evaluate the overall knowledge, attitude and practices (kap) of jordanian citizens to the ongoing international situation regarding the emergence and pandemic nature of covid- . however, we were lucky that our study was almost complete when the first case of the disease was reported in jordan. hence, we rapidly adapted our study in order to engage more participants and to evaluate how this reported case altered the kap of jordanian citizens. the aim of this report is to aid decision makers in their understanding of the public knowledge and awareness of the disease, the attitudes of the public and their practices to take necessary measures to prevent disease spread. this was a cross-sectional study conducted during the early days of covid- pandemic of and and over the period from th february to th march . when the study started there were no reported cases in jordan. during the study, the first covid- case was reported in jordan, which encouraged the authors to extend the study and include more participants in order to identify how case reporting would alter the public kap towards covid- . the study targeted adult resident jordanian nationals. it was a questionnaire based and self-selection study. the institutional review board (irb) at the deanship of scientific research, the university of jordan, approved the study protocol and the questionnaire (irb / ). the questionnaire was developed based on extensive literature review [ , [ ] [ ] [ ] [ ] . it consisted of four main sections; (a) demographic and general characteristics of the participants, (b) participants knowledge regarding covid- , its mode of transmission, and its preventative measures ( questions), (c) participants' attitudes towards covid- and its preventative measures ( questions) , and (d) participants' practices towards prevention of covid- transmission ( questions). the questionnaire content was translated from english into arabic and then critically revised and face-validated by several academic colleagues. since the jordanian general public knows covid- as "coronavirus disease", this term was used in the questionnaire. amendments were made according to the notes and comments received after piloting to a sample of adults chosen from the friends, neighbors and coworkers of the authors. the questionnaire was then developed as a google form and disseminated to participants via mobile applications, eg: whatsapp [ , ] . snow ball sampling technique was used to distribute the google form and enroll participants [ , ] . the link to the google form was sent to the contact lists of the authors, in addition to neighbors, friends, relatives, coworkers of all levels and departments, friends of friends, different whatsapp groups, who were also asked to complete the form and to disseminate it to all the people they know in jordan. this method of disseminating the questionnaire was selected in view of the need to reduce direct contact with participants under the pandemic situation. participants were asked not to identify themselves in any fashion. also they were informed that completing the questionnaire and returning it were considered as a formal consent to participate in the study since the participant can, at any moment, stop answering questions or choose not to "submit" the final form. a minimum sample of adults aged and older was estimated based on the following equation [ ] : n ¼ where n is the sample size, zα: type one error = . when α = %; zβ: type two error = . when β = %; q = -p: expected non-prevalence; p = proportion in the population possessing the characteristic of interest (based on the estimate that % of the respondents knew general information about covid- , its routes of transmission and the main preventative measures), d = one-half of the desired interval of confidence, in this study d = %. accordingly, by filling in the equation, n = . x . ( . + . ) / . = . . statistical analysis was performed using spss version . (spss inc., chicago, il). descriptive statistics were used to describe demographic characteristics of participants. categorical variables were presented as valid percentages to account for missing data with their frequencies, while continuous variables were presented as mean with standard deviation (sd). two scores were calculated for the participants: knowledge about covid- and its preventative measures, and participants' practices towards preventing transmission of covid- . participants' knowledge scores were evaluated using the number of correct questions they answered out of covid- knowledge questions. in order to calculate the knowledge score, correct answers were assigned a score of one, while wrong or "i don't know" answers were assigned a score of zero. participants were considered adequately knowledgeable if their knowledge score, for all knowledge questions, was higher than or equal to the sample median of the knowledge score. internal consistency of the knowledge questions was tested using cronbach alpha coefficient as a reliability test. the results showed that the cronbach alpha for knowledge ( items) was . . cronbach alpha within the range . to . is considered adequate and reliable [ ] . similarly, participants practice towards preventing transmission of covid- score was calculated by assigning a score of one for appropriate practices, while inappropriate practices were assigned a score of zero. the maximum value of practice score is six based on the total number of correct practice items. participants' knowledge, attitudes and practices were compared before and after the reporting of the first confirmed case of coronavirus in jordan which was documented on nd march . by default, 'google forms' identifies the date and time of each participant's response which enabled us to sort the responses submitted into those made before and after case reporting. chi-square test was used for these comparisons. parametric tests including independent sample t-test and one way anova test were used to test the differences among the variables that affect both knowledge and practice scores (bivariate analysis) as specified in the results section (data were first tested for normality using kolmogorov-smirnov (k-s) test and for homogeneity of variances using levene's test). in addition, independent sample t-test was used to test the differences in the scores between the two groups (before and after case reporting). all hypothesis testing was two-sided. a p-value of < . was considered significant. the total number of participants recruited in the study was . participants were recruited before case reporting and participants were recruited after case reporting. more than % of participants were in the age group of - ( . %, n = ). females accounted for . % (n = ) of the study population. more than % of participants had a university or postgraduate degree ( . %, n = ), and � %, (n = ) had education in the medical field. since the cohort participating in the study after case reporting differed from those participating before case reporting, there were variations in the sociodemographic data of the two groups (p< . , chi square) except for gender and working in the medical field which were similar (p> . ). participants' sociodemographic characteristics are presented in table . the mean knowledge score for the whole study population was . ± . (out of the knowledge questions), with . % (n = ) of the participants having a score equal to or higher than the median ( . ) and consequently were considered to have adequate knowledge about covid- . only . % (n = ) of the participants were able to correctly answer all of the knowledge questions and % (n = ) of participants were able to correctly answer questions. in addition, % (n = ) of participants knew the general information related to the covid- , its symptoms and the highest risk group. however, more than % of the study population incorrectly thought that death is a common complication of covid- ( . %, n = ) ( table ) . regarding covid- transmission, a major gap of knowledge regarding routes of covid- transmission was identified where only . % (n = ) of the population correctly recognized all the routes of covid- transmission. considering covid- preventative measures, more than half of the participants were able to identify the main preventative measures. however, only . % (n = ) of them knew plos one that a facemask should not be used daily as a preventative measure for covid- transmission (which was a recommendation by who and moh at the early days of the pandemic). in general, the mean knowledge scores of participants improved after case reporting (when compared with those exhibited before case reporting) in the three areas studied: definition, signs and symptoms, risk groups and complications (mean score . ± . vs . ± . , p< . ); mode of transmission (mean score . ± . vs . ± . , p = . ) and prevention of transmission and treatment (mean score . ± . vs . ± . , p< . ). accordingly, the total knowledge score was improved from . ± . before case reporting to . ± . after case reporting (p value < . , independent sample t-test) ( table ). the detailed frequencies for individual questions are presented in table . the most common source of participants' information about covid- was social media, such as facebook, twitter or others ( . %, n = ), followed by internet searching such as google ( . %, n = ), and television ( � %, n = ). a much lower proportion of respondents relied on newspapers ( . %, n = ), friends ( . %, n = ), brochures ( . %, n = ) or physicians' offices ( . %, n = ) to get information. a significantly higher knowledge score (p-value < . ) was associated with using internet search (score = . ) as sources of information (p-value < . ; independent sample t-test), while other sources were not associated with significantly higher knowledge score. most participants had positive attitudes regarding their role in preventing covid- . in particular, . % of participants thought that they could protect themselves against covid- and . % of them thought that following advised preventative measures would be effective. however, more than % of participants didn't trust the jordanian ministry of health's (moh) approach to confronting covid- ( . %, n = ) or the information provided by governmental authorities about the exact number of cases ( . %, n = ). similarly, more than half of participants believed that the occurrence of coronavirus was related to international tension and trade wars ( . %, n = ) and . % (n = ) of participants believed that the recent coronavirus was created in a laboratory and was not naturally occurring. on the other hand, most participants were either unsure or didn't believe that herbal remedies ( . %, n = ) or antibiotics ( . %, n = ) were effective in treating or preventing covid- . interestingly, many of the participants' attitudes had changed after reporting the first jordanian case of covid- ( nd march ). most importantly, the percentage of participants who believe that covid- was a serious and life threating infection dropped significantly from . % to . % (p value < . ; table ). on the other hand, the proportion of participants who trusted moh in confronting covid- increased significantly from . % to . % (p value< . ). similarly, the percentage of participants who thought that they could protect themselves against infection with covid- ( . % vs. . %, p value < . ) and those who thought that treatment approaches were effective also increased significantly (from . % to . %, p value = . ). the mean practice score of all the participants was . ± . (out of the practice questions) with . % (n = ) of the participants having a score equal to or higher than and consequently were considered as having adequate practices to prevent spread of covid- . respondents' practices are presented in table . participants' practices to prevent transmission of covid- in terms of avoiding hand shaking, hugging, kissing and crowded areas, and using disinfectants were appropriate in more than % of participants. interestingly, all these practices have increased significantly after reporting the first case of covid- . on the other hand, the proportion of participants wearing facemasks and avoiding the purchase of chinese table ). overall, the observed practice score improved significantly when compared between respondents before case reporting and after case reporting ( . ± . vs. . ± . respectively, p value < . , independent sample t-test; table ). factors affecting participants' knowledge and practice towards preventing covid- were determined by bivariate analysis. overall participants' knowledge and practice scores were associated with age, educational level and education in health or medical field. in addition, participants' knowledge score was associated with gender and work in the medical field. participants' practice score was also associated with marital status. for each sociodemographic characteristic, the calculated knowledge score (table ) or practice score ( table ) was improved after case reporting when compared to the value before case reporting. detailed results are shown in tables and . since the who declaration of covid- as a public health emergency on th january , health authorities around the world, led by who, have initiated huge campaigns to increase the awareness of the people toward the disease and to disseminate the appropriate practices to prevent its transmission [ ] . as a member of these authorities, the moh in jordan started similar campaigns relying on different forms of media. the first case in jordan was reported on nd march for a citizen returning from italy [ ] . our study commenced by distributing the questionnaires on th february before the reporting of the first case of covid- in jordan, and the questionnaire process ended on th march. by that time, the measures taken by the country included closure of schools and universities, quarantining thousands of incoming air passengers in hotels, and prohibiting any kind of social gathering (including the closure of all mosques and churches). during that period, the number of cases reported increased to without fatality. this gave our team an opportunity to compare the change in knowledge, attitudes and practices of jordanians towards covid- before and after the reporting cases of covid- illness. the sample population of this study ( participants) was largely well educated with females predominating. the observed skew in the sample toward females and well educated participants has also been seen in previous studies in jordan [ ] [ ] [ ] [ ] . in addition, the vast majority of participants were below the age of years, which is representative of the generally younger population of jordan, where at the end of the estimated proportion of population below years was around % [ ] . the overall knowledge of the respondents was generally adequate (total knowledge score . out of ). they exhibited excellent knowledge of the organs targeted by the virus, its nature as a zoonotic disease, and its signs and symptoms. however, the respondents had an exaggerated idea about the expected death rate of the disease where more than % considered death to be a very common outcome. this idea could have been drawn in their minds due to the effect of media focus on death rates and novel cases, rather than recovered cases [ , ] , thus, giving the audience or readers the impression that this disease is highly fatal. the respondents were well aware of the most common routes of the disease transmission, such as close contact, respiratory droplets or touching contaminated surfaces. the vast majority of participants (> %) had an excellent knowledge about the required measures to prevent the disease. however, the more scientific questions related to the role of influenza vaccine in protecting from covid- or the one related to use of a specific drug to treat the illness were correctly answered by only around two thirds the participants. the participants' knowledge was gained through multiple sources of information. the electronic sources such as social media ( %) and internet ( %) were the top sources followed by television ( %). these results suggest that in this era, where electronic media sources are predominate at the expense of more traditional media sources, health authorities should focus their healthrelated campaigns on electronic media and they should consider adding social media platforms to their public communication tools, in order to reach the vast majority of population [ ] [ ] [ ] [ ] . it is noteworthy that people who obtained their information from internet searches had significantly higher knowledge scores than those using other sources. this is probably due to the fact that people who were keen to get more information about the disease actively sought this information from the internet. however, those relying on social media, such as facebook, twitter and whatsapp may have received inaccurate information since social media platforms often lack fact-checking and editorial control [ , ] . when investigating the knowledge of the participants the major factors were; the educational level, education background, and the field of work (p value within group < . for each) ( table ). this was anticipated and is in line with previous studies that compare the knowledge of the general population about a specific health-related issue with those of higher levels of education or with a health-related backgrounds [ , ] . the latter would have much better knowledge. comparing the mean knowledge scores of the respondents before and after case reporting (table ) , showed an improvement in the respondents' knowledge after case reporting (p value between groups < . , independent sample t-test). we are aware that differences in the population characteristics before and after case reporting might contribute to observed changes in the knowledge score. however, statistical analysis of the factors affecting participants' knowledge (table ) exhibits that the observed improvement in the knowledge was significant in all the classes of each characteristic (age, gender, marital status, etc, p value between groups < . ), indicating a palpable effect of case reporting on the participants' knowledge. apparently, people become more interested in learning about a disease when it is seen to be proximal to their vicinity as has been seen in other similar situations [ ] . this suggests the importance of pursuing health campaigns and associated recommendations when case reporting of any outbreak or epidemic commences in a country, as the public seems to become more receptive to that additional information. a significant change in the attitudes of participants in many aspects was noticed after reporting cases of covid- illnesses in jordan. unexpectedly, the participants seemed to become more optimistic and comfortable after the reporting of cases of covid- . this optimism appeared in their perception to the severity of disease as a life threatening one, the effectiveness of preventative measures, their ability to protect themselves, the effectiveness of the treatment approaches and the ability of moh to confront the disease. although this is initially puzzling, it can be explained by the unique situation in jordan. shortly after first case reporting in jordan, there was a sense of panic among the population. in order to calm the public and fight the rumors, the first covid- patient was interviewed in hospital where he was isolated, by different national and regional tv and radio channels [ ] . the patient tried to comfort the people about his situation, since he only suffered from mild respiratory illness. being a traveler returning back from italy, which was hard hit by the pandemic at that time, he compared the looser measures taken by italian authorities to contain the disease with the tougher measures taken in jordan, and he praised the latter. the same thing happened with the second case who only suffered from mild illness. the situation of both patients was of great public interest until they were discharged from hospital. apparently, the message perceived by the public from both patients was that the disease is mild and can be prevented, and that the measures taken by the authorities are effective. our study suggests that the jordanian government's open approach with the public about the disease, its spread, and the necessity for stringent control measures enhanced the optimistic attitudes of the participants towards the disease and its management after case reporting in the country. on the other hand, the attitudes of the participants in other areas remained the same before and after reporting cases in jordan. more than half the respondents indicated their willingness to buy the vaccine (most pharmaceuticals are paid for by the patient in jordan) and the number increased a little more if the vaccine was offered free of charge. these figures are relatively high compared to the general attitudes of jordanians towards vaccinations other than the mandatory ones at childhood [ , ] . this improved attitude could be related to the worldwide worries about this disease, which have made the jordanians more willing to protect themselves against coronavirus. as for the emergence of this virus, almost half of the participants believed that the virus was created in a laboratory and more than half believed that its emergence was the result of political reason linked to international tension or trade war. this conspiracy theory is not limited to jordanians, and has been reported worldwide. some americans accused china of bioengineering the virus as a bioweapon and conversely, some chinese have accused the american military of introducing it into china. nevertheless, these theories have been refuted in the media and by scientific studies [ ] [ ] [ ] [ ] . the practices of the participants in order to prevent the transmission of the virus were found to be adequate for more than two thirds of the respondents. however, there was a remarkable improvement (p < . ) in the participants' practices after the reporting of cases of the disease in jordan. the practices evaluated included; avoidance of shaking hands, avoidance of kissing, avoidance of crowded places, and an increase in the use of disinfectants (table ). this improvement in practices' scores was anticipated because the public was observing the disease having increased proximity to their areas, thus they were more willing to engage with the recommendations of the moh regarding covid- . the improvement in practices' scores seen among the population after case reporting compared to those before case reporting cannot be attributed solely to differences in sample population, because the increase in practice score was obvious in all the population characteristics studied (table ). after reporting cases in jordan, there was a significant decrease in the number of participants using facemasks when going outside. this contradicts the behavior of chinese people during the epidemic in their region, where % of a study population indicated wearing facemasks when leaving homes [ ] . nevertheless in this respect, the practices of jordanian respondents exhibited better adherence to the instructions of moh at the time. in the early days of the pandemic who and moh instructions to the general public were not to use facemasks, as it was feared this would lead to shortage of masks for essential health and care workers. many other factors affected the overall practices of the respondents. participants with ages of more than years had statistically better practices than those in the lower age groups ( - yr and - yr; p value within group < . ). this implies that older respondents are more cautious about their health than younger participants due to who and moh warnings that people above the age of years were at higher risk of developing severe complications than those of younger ages [ ] . these findings suggest that the public is willing to implement the recommendations of the health authorities when continuously and firmly directed to do so. surprisingly, the negative factors affecting the overall practices of the participants towards the prevention of transmission are the education level and having a health-related education. these participants scored lower than their counterparts in terms of the best practices (table ). this finding, albeit odd is not uncommon. in a study among health care workers in saudi arabia to evaluate their kap about middle east respiratory syndrome (mers), physicians, pharmacists, nurses and technicians showed low to average scores on practices, but better knowledge and attitude scores [ ] . we speculate that having a better education, particularly in a health-related field, provides the participants with confidence that they are aware of the risks and know better how to protect themselves. another disappointing finding is that the overall participants practice score of those working in the health field is the same as those working outside this field ( . for each, table ). this finding should be alarming to the health authorities and health care sector, since these workers will be in the front line in combating the epidemic. being lenient in applying the strictest measures and practices in protecting themselves and preventing the spread of infection could lead to a disaster. therefore, the health sector should immediately intensify education and extensive training and setting guidelines for the proper practices among healthcare workers of different specialties. the findings of the study should be interpreted with the following limitations in mind: • sampling of the study was made through social media, what's app in particular, which could pose some bias to the study where underprivileged people or those having problems in using electronic devices may not be able to participate, thus, will be under-represented in the sample. • females and people with education level of more than years were over-represented in the sample studied when compared to the general jordanian population. • like any other self-reported study, responses (mainly of attitudes and practices) could have been reported based on social desirability, not the actual situation of the participants. severe acute respiratory syndrome coronavirus (sars-cov- ) and coronavirus disease- (covid- ): the epidemic and the challenges who [internet]. centers for disease control and prevention who. events as they happen-rolling updates on coronavirus disease early transmission dynamics in wuhan, china, of novel coronavirus-infected pneumonia novel coronavirus: where we are and what we know coronavirus disease treatment: a review of early and emerging options draft landscape of covid- candidate vaccines modes of transmission of virus causing covid- : implications for ipc precaution recommendations q&as on covid- for older people refugee population by country or territory of asylum-| data health care and pharmacy practice in jordan higher health council & world health organization government suspends educational system in a bouquet of coronavirus preventive measures government announces decisions to fight against coronavirus jordanians now ponder economic cost of coronavirus. in: al-monitor, the pulse of the middle east covid- ) advice for the public bin saeed a. knowledge, attitude and practice of secondary schools and university students toward middle east respiratory syndrome epidemic in saudi arabia: a cross-sectional study covid- )-how coronavirus spreads covid- )-how to protect yourself & others. in: centers for disease control and prevention public knowledge, attitudes and practices towards covid- : a cross-sectional study in attitudes and practices towards covid- : an epidemiological survey in north-central nigeria sage research methods foundations parental knowledg attitudes and behaviours towards influenza a/h n in italy global patterns in students' views of science and interest in science who says people receiving packages from china not at risk of contracting coronavirus-society & culture-tass los angeles daily news who. coronavirus disease (covid- ) situation report- promotion of appropriate knowledge and attitude towards medicines among schoolchildren in jordan: the role of teachers knowledge and information sources about covid- attitudes and behavior regarding antibiotics use and misuse among adults in the community of jordan. a pilot study albsoul-younes am. knowledge, awareness and practices towards seasonal influenza and its vaccine: implications for future vaccination campaigns in jordan. fam pract table : estimated population of the kingdom by sex why coronavirus is killing far more men than women-the washington post. the washington post more covid- cases, deaths reported in rest of world than in china-who the use of social media among saudi residents for medicines related information internet and social media use for antibiotic-related information seeking: findings from a survey among adult population in italy taking the paper out of news mers-cov infection: mind the public knowledge gap fake news: spread of misinformation about urological conditions on social media the trump effect: with no peer review, how do we know what to really believe on social media? clin colon rectal surg influenza vaccination coverage rates, knowledge, attitudes, and beliefs in jordan: a comprehensive study hepatitis b knowledge, perceptions and practices in the french general population: the room for improvement jordan free from corona cases as infected citizen left quarantine seasonal influenza vaccination among older adults in jordan: prevalence, knowledge, and attitudes. hum vaccines immunother covid- coronavirus was not bioengineered. here's the research that debunks that idea covid- coronavirus epidemic has a natural origin-sciencedaily coronavirus did not come from a lab: experts debunk myths that china or usa bioengineered covid- . mail online evolutionary origins of the sars-cov- sarbecovirus lineage responsible for the covid- pandemic. nat microbiol knowledge, attitudes, and practices towards covid- among chinese residents during the rapid rise period of the covid- outbreak: a quick online cross-sectional survey who. coronavirus disease (covid- ) situation report- middle east respiratory syndrome (mers): comparing the knowledge, attitude and practices of different health care workers the authors would like to thank professor phillip collier (visiting professor, faculty of pharmacy and medical technology, university of petra) for his critical review of the paper and proof reading. haddadin. the design and timing of this study could not have been more fortuitous, in that it allowed the authors to rapidly adapt and expand a preliminary study into a fully operational before-andafter study of kap towards covid- . the findings of this study are necessarily complex, but generally show that the population reacts well to open and honest governmental advice about pandemics and can rapidly adopt safe practices in response to appropriate advice. the international relevance of this work is obvious, in that jordan achieved one of the lowest rates (per million population) of covid- infection ranking and out of in the number of cases and related fatality respectively, in the world (https://www.worldometers.info/ coronavirus/#countries; / / ). key: cord- -o hmzaxm authors: kühnel, martina b; marchioro, linda; deffner, veronika; bausewein, claudia; seidl, hildegard; siebert, sarah; fegg, martin title: how short is too short? a randomised controlled trial evaluating short-term existential behavioural therapy for informal caregivers of palliative patients date: - - journal: palliat med doi: . / sha: doc_id: cord_uid: o hmzaxm background: informal caregivers of palliative patients show higher levels of depression and distress compared with the general population. fegg’s ( ) existential behavioural therapy was shortened to two individual -h sessions (short-term existential behavioural therapy). aim: testing the effectiveness of sebt on psychological symptoms of informal caregivers in comparison with active control. design: randomised controlled trial. setting/participants: informal caregivers of palliative in-patients. methods: the primary outcome was depression; secondary outcomes were anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. general linear mixed models allow several measurements per participant and change over time. reasons for declining the intervention were investigated by rosenstock’s health belief model. results: overall inclusion rate was . %. data of caregivers were available ( . % females; mean age: . years, standard deviation (sd): . ); participants were included in the main analysis. participation in sebt or active control was not significantly associated with post-treatment depression. outcomes showed prevailingly significant association with time of investigation. self-efficacy, scepticism of benefit of the intervention, belief of better coping alone and support by family and friends were significant factors in declining participation in the randomised controlled trial. conclusion: inclusion rate was tripled compared with a previously evaluated longer ebt group intervention. by shortening the intervention, inclusion rate was traded for effectiveness and the intervention could not impact caregivers’ psychological state. early integration of sebt and combination of individual and group setting and further study of the optimal length for caregiver interventions are suggested. • • informal caregivers of palliative patients are prone to higher levels of depression compared with the general population. informal caregivers are family members and other persons whose support of the patient is not financially rewarded. supporting informal caregivers is an essential part of palliative care, as defined by the world health organization. informal caregivers are prone to higher levels of depression, anxiety, strain and burden than the general population, , and the number of interventions to support them is growing. , however, a review of caregiver interventions identified a lack of proactive interventions and supposed that caregivers would prefer interventions that improve the ability to care. mindfulness-based interventions for caregivers could potentially close this gap. despite the challenges for caregivers to access interventions due to scheduling difficulties and them having to leave the patient alone, mindfulness showed positive influences on depression, strain and quality of life. fegg et al. developed existential behavioural therapy (ebt), an intervention aimed at informal caregivers of palliative patients. ebt was implemented in a group setting with a total of h focusing on mindfulness practice, strengthening resources, finding meaning, establishing self-care and developing personal values. medium to large effects on anxiety and quality of life and medium effects on depression were demonstrated. a weakness of this study was the low uptake of the intervention with . %. short-term existential behavioural therapy (sebt) aimed to be more compatible with caregivers' daily life. a qualitative study embedded in the fegg study had identified two ebt elements regarded as most helpful by caregivers: social support in the group and self-regulation via strengthening resources and practicing mindfulness. despite the support provided by the group, an individual setting was chosen for sebt to ensure a quicker start of the intervention. to condense ebt for the individual setting, sebt focused on the two elements of self-regulation, shortening it to two -h sessions. a feasibility study indicated that sebt was feasible and accepted by caregivers. although sebt is not a treatment applied for a disorder, the term 'therapy' was kept to mark the affiliation with ebt. this study's aim was to evaluate the effectiveness of the sebt intervention in comparison with a usual, nondirective psychological intervention using a randomised controlled trial study design. the primary outcome was informal caregivers' level of depression, as the fegg study had shown long-term effects on depression. secondary outcomes were informal caregivers' levels of anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. furthermore, we analysed caregivers' reasons to decline participation in the randomised trial as more research in this field had been suggested. this randomised controlled trial has a parallel-group design with equal : randomisation and four assessments: pre-treatment, post-treatment and follow-ups after weeks and months. we embedded a follow-up of those informal carers who declined to participate. the study was approved by the ethics committee of ludwig-maximilians-university of munich (no: - ) and was registered with clinical.trials.gov (nct ). informal caregivers were recruited from the munich university hospital palliative care unit, germany. inclusion criteria were minimum age of years and fluency in german. one caregiver per patient was included, preferably the person closest to the patient. excluded were professional legal representatives and caregivers with severe mental illness (e.g. dementia, acute addiction). the sample size was calculated according to fegg's study: psychotherapy research reports treatment effects between . and . standard deviation (sd). to achieve a power of . at % significance level using dupont what this paper adds? • • ebt was shortened to two individual -h sessions (sebt) to fit better into caregivers' daily lives. • • this randomised controlled trial tests the effectiveness of sebt on psychological symptoms of informal caregivers in comparison with an active control. implications for practice, theory or policy • • shortening the intervention tripled inclusion rate to . % reaching more caregivers. • • inclusion rate was traded for effectiveness and the intervention could not impact caregivers' psychological state. • • early integration of sebt and combination of individual and group setting are discussed. • • this study's results suggest further study of the optimal length for caregiver interventions. and plummer's sample size calculation and considering a dropout rate of %, participants were needed in every arm of the study. caregivers were approached earliest after the day of the patient's admission. they were screened for the inclusion criteria by psychologists with clinical experience. potential participants were contacted in person or by phone and informed orally and in written form about the study. caregivers who did not want to participate were asked to take part in the decliners' follow-up. all participating caregivers and patients provided written informed consent. consent of a legal guardian was sought for patients unable to give consent. immediately after making the first appointment and receiving the first questionnaire, participants were randomised by a randomisation list which was computergenerated with blocks of , each containing five control and five sebt assignments in random order. participants were informed about their allocation in the first session. the study was conducted on weekdays between january and february . recruitment was suspended for months due to staff change (march -august ) and three times due to staff vacation ( intervention sebt and control intervention both comprised two sessions in an individual setting lasting - min; appointments were arranged individually. the interventions took place in a separate room in the palliative care unit and in a psychotherapeutic practice. three psychologists with several years of experience in behavioural psychotherapy were trained using video feedback. sebt and control group sessions were audiotaped and rated for treatment integrity using coding guidelines and checklists (range - : ' ' = element missing to ' ' = fully consistent with the manual). control group. the active control group was oriented towards carl rogers' client-centred therapy, characterised by acceptance, congruence and empathic understanding, as recommended in supporting informal caregivers in a palliative setting. there was no mention of mindfulness or resources. sebt group. the first sebt session focussing on mindfulness included: introduction, psychoeducation about mindfulness, -min body scan, -min mindful breathing exercise, addressing questions and motivation to practice mindfulness every day using a cd provided. the second sebt session focussing on resources included: introduction, psychoeducation on psychological meaning of resources, encouragement to express strengthening areas and activities (based on schedule for meaning in life interview ), imaginative exercise of the inner image of the strongest resource addressing all five senses, choice of a symbol as reminder and prime, addressing questions, motivation to practice mindful breathing and imaginative exercise using the cd. caregivers' demographic data and patients' medical data were collected through self-report and clinic chart review. participants of the randomised controlled trial completed standardised questionnaires at the time of study entry (t ), after the second intervention session (t ) and weeks (t ) and months (t ) after the second intervention session. participants of the decliners' follow-up received three questionnaires: at t and follow-ups weeks (t ) and months (t ) after t , with no decliner questionnaire at t . all measurement instruments were used in a validated german version. primary outcome. level of depression was measured with patient health questionnaire, items; a score > is associated with clinical levels of depression, and scores are sums ranging from to . , secondary outcomes. generalised anxiety disorder was assessed using the generalised anxiety disorder questionnaire, items; a score > indicates general anxiety disorder, and scores are sums ranging from to . , subjective distress was measured using the national comprehensive cancer network's distress thermometer; a score > indicates a clinically relevant level of distress, scale range - , from 'no distress' to 'extreme distress'. minor mental disorders were assessed using the general health questionnaire, items, with higher scores indicating higher level of mental disorder; scores are sums of item values ranging from to . , positive and negative affect were measured using the positive and negative affect schedule, with higher scores indicating higher levels of affect; scores ranging from to are means of positive and negative items, respectively. , life satisfaction was measured using the satisfaction with life scale, with higher scores indicating higher degree of satisfaction; scores are sums of item values ranging from to . , quality of life was assessed using the world health organization quality of life questionnaire, abbreviated version: scores range from to , with higher scores denoting higher quality of life; scores were built according to the manual guidelines, including handling of missing data. , health-related resource use of the past months (number of physician contacts, physiotherapist contacts, hospital days, and rehabilitation days) was collected using the german questionnaire for health-related resource use in an elderly population (at t and t ). individual costs were added up after assigning a cost to each component based on unit prices published by bock et al. three numerical rating scales with one item each measured quality of life, physical impairment and psychological impairment, with scores ranging from to , with higher scores indicating higher levels. of all the used scales, only in the manual of the world health organization quality of life questionnaire, , guidelines on how to treat missing data were provided: outcomes were only computed if at least % of the items in a scale were available and the missing items were imputed with the mean of the available items. otherwise the whole observation was discarded. for consistency, we applied this approach to all scales. belief model, designed to predict health-promoting behaviour, was employed in order to understand reasons for declining. , the following four factors of the health belief model each comprised several variables and were included in questionnaires for decliners and for the randomised controlled trial. 'modifying factors': age, gender, knowledge about depression (numerical rating scale ranging from to ) and self-efficacy (german general self-efficacy short scale) scores are means ranging from to , with higher scores indicating higher levels. factor 'perceived susceptibility and severity': two numerical rating scales with - ranges on susceptibility for and severity of suffering from depression. factor 'perceived benefits and barriers': four numerical rating scales on scepticism of benefit of the intervention (adapted from patient questionnaire on therapy expectation and evaluation, - range), belief in benefit (adapted from german questionnaire for measurement of psychotherapy motivation, - range), belief one should cope alone (adapted from german questionnaire for psychotherapy motivation, - range), and belief that the intervention benefit would be greater than the costs ( - range). higher scores indicate higher agreement. factor 'cues to action': three numerical rating scales on advice from family/friends to accept psychological support, the extent of support by family/friends and the quality of the relationship with the patient, with higher scores indicating higher levels. changes in the outcomes over time were evaluated via general linear mixed model with random intercept for subjects. these models allowed several measurements per participant and change over time. a separate regression model was built for each outcome measure. outcomes from all three post-treatment questionnaires (t , t , t ) were dependent variables. variables 'group' (sebt or control group) and 'time of investigation' were independent variables. the interaction effect between 'group' and 'time of investigation' was only included if significantly different from zero. the pre-treatment (t ) value of each outcome measure was included as a predictor variable, capturing individual status before the treatment. in all models, we controlled for age, gender, relationship with the patient (patient is partner/child vs other); patient's time of death (patient alive, unknown, deceased > months before measurement, < months before measurement); employment (employed/student vs retired/unemployed); the psychologist delivering the intervention (psychologist , or ); and other support used (e.g. social worker, pastoral care, other psychologist; yes, no or unknown). besides the main model (model ), we conducted sensitivity analyses considering the following two subgroups of the study population: only participants (sebt or control group) who attended both interventional sessions (model ) and all control participants and only sebt participants who had practised mindfulness at least once using the cd (model ). sensitivity analyses controlling for missing data were also conducted. data were analysed according to the principle 'full analysis set' which is as complete and as close as possible to the intention to treat ideal of including all randomised subjects. the regression analyses included only individuals with at least one intervention session and participation in the investigations before (t ) and after the intervention (t ). a binary logistic regression was conducted to investigate which factors led to declining or accepting the intervention. based on rosenstock's health belief model, stepwise inclusion of four factors emulated the process of decision-making for or against the intervention. an overall result was deduced from all four steps. in addition, linear mixed models with repeated measurements were used to model all outcome parameters at t , t and t in order to detect differences in outcomes between the participants of the randomised controlled trial and the decliner participants. to analyse differences in direct health care costs, the non-parametric mann-whitney u test was used due to skewed distribution of the data. statistical analyses were performed using ibm spss statistics v. ; a value of p < . was considered significant; a value of p < . was considered a trend. results are reported following the consort statement. out of potential participants, were excluded during recruitment ( . %; see figure ), hence caregivers were contacted ( . %). of these, participated in the decliners' follow-up and declined any participation. a total of caregivers were randomised into the sebt or the control group; the inclusion rate was . %. during the study, cases were excluded as they had been wrongfully assigned. after the randomisation, participants dropped out before t ( sebt, controls). in total, participants of the randomised controlled trial took part in the pre-intervention examination (t ). at t , sebt and control participants showed no significantly different characteristics (see table ). the mean age was . years (sd . ) and most participants were female ( . %). more than one-third of the participants held a university degree ( . %), more than half were married ( . %); nearly one-third was retired ( . %) and twothirds employed (full time . %, part time . %). participants were mostly either patients' partners (including wives or husbands; . %) or their children ( . %). cancer was the prevailing diagnosis of the patients ( . %). two-thirds of participants received interventions by psychologist ( . %). most patients were alive at t ( . %; . % deceased ⩽ months ago; . % unknown; n = ). at t , patients were mostly alive ( . %) or had deceased during the last months ( . %; . % unknown; n = ). at t , most patients had deceased during the last months ( . %; . % alive; . % deceased > months ago; . % unknown; n = ), and at t , most patients had a due to missing data at t , participants' datasets were excluded from analyses. b despite missing data at t , participants' datasets were included in analyses. thirty participants of the pre-intervention examination (t ) were not included in the main data analysis because they dropped out during the intervention or had missing data at t (see figure ). an independent-sample t-test indicated that these drop-outs had higher levels of negative affect at t (mean: . , sd: . ) than participants included in the main analysis (mean: . , sd: . ; p-value: . ), and they tend to higher levels of minor mental disorders (mean: . , sd: . ) than participants included in the main analysis (mean: . , sd: . ; p-value: . ; unequal variances). they did not significantly differ in any other outcome or characteristic. a total of participants were included in the main regression analysis (model ) according to the principle of 'full analysis set' as they participated in at least the first two investigations at t and t . these participants showed mild and subclinical levels of depression at t (mean: . , sd: . ). the sample's average score on anxiety was just under the cut-off for clinically relevant levels (mean: . , sd: . ). their average level of distress was above the score indicating clinical relevance (mean: . , sd: . ). at t , datasets were available and included in analyses. at t , datasets were available and included. the percentage of scales with at least one missing item was . %. by including observations which had at least % of items completed, we were able to lower the number of scales that had to be discarded to . %. in total, intervention sessions were held (sebt and control, including dropouts), participants received only one session. audiotapes of the intervention sessions were available ( . %), eight were incomplete and not rated; five participants declined consent for audiotaping. audiotapes were rated to evaluate treatment integrity. the therapists' adherence to the intervention manual was high (sebt mean: . , sd: . ; control mean: . , sd: . ). the level of depression did not differ significantly between sebt and control group (sebt beta: -. ; control group as reference category); this was true for all three models (see table ). apart from the impact of pre-treatment depression, there was a trend for the time of investigation being associated with the post-treatment depression level (t beta: -. ; t beta: - . ; t as reference category), as depression was on average lower at t and t than at t . the interaction effect between the group and the time of investigation was not included in the main model since it was not significantly different from zero. according to the results of the main models, all posttreatment secondary outcomes did not significantly differ between sebt and control group (for tables see supplemental material appendix b). the interaction effect between the group (sebt/control) and the time of investigation was not included in the main models as it was not significantly different from zero, except for psychological impairment. time of investigation was significantly associated with outcomes anxiety (t beta: - . ; t beta: - . ; t as reference category), positive affect (t beta: . ; t beta: . ) and minor mental disorders (t beta: . . ; t beta: . ), and was associated by trend with negative affect (t beta: . ; t beta: . ) and quality of life (numerical rating scale; t beta: . ; t beta: . ). patients' time of death was significantly associated with outcomes negative affect (alive beta: . ; deceased > months ago beta: -. ; time of death unknown beta: . ; deceased ⩽ months ago as reference category), satisfaction with life (alive beta: - . ; deceased > months ago beta: . ; time of death unknown beta: - . ), subjective distress (alive beta: . ; deceased > months ago beta: - . ; time of death unknown beta: . ) and psychological impairment (alive beta: . ; deceased > months ago beta: . ; time of death unknown beta: . ); patients' time of death showed a trend to be associated with anxiety (alive beta: . ; deceased > months ago beta: - . ; time of death unknown beta: . ). relationship with the patient was significantly associated with quality of life (numerical rating scale; partner/child beta: -. ; other relationship as reference category). age showed a trend to be associated with subjective distress (beta: . ) and gender showed a trend to be associated with psychological impairment (male beta: -. female gender as reference category). in addition, we conducted sensitivity analyses regarding missing data (for tables see supplemental material appendix c). participants without missing items in any of the relevant outcome scales were regarded as having no missing data (n = , . %); they were significantly younger than participants with missing data (n = ). a variable discriminating between these two groups was added to an additional set of regression analyses. these analyses yielded highly similar results compared the analyses described above, apart from the variable missing data being associated by trend with negative affect (no missing data beta: . ). at t , a mann-whitney u test showed that, at t , there was no significant difference between the median of direct health care costs for the past months of sebt participants (median: € , n = , interquartile range: . ) and controls (median: € , n = , interquartile range: . ). at t , there was also no significant difference between the median of direct health care costs for the previous months of sebt participants (median: € , n = , interquartile range: . ) and controls (median: € , n = , interquartile range: . ). data of decliners were available at t , as dropped out before t . data of decliners were available for the follow-up at t and data of decliners at t . declining participants were significantly older (mean: . years, sd: . ) than participants of the randomised controlled trial (mean: . , sd: . ) but did not significantly differ regarding gender, relationship status or employment. linear mixed models with repeated measurements modelling all outcome parameters at t , t and t showed no differences in any outcomes between the participants of the randomised controlled trial and the decliner participants. the binary logistic regression showed that the preference towards the decliner study significantly depends on 'perceived benefit and barriers' and 'cues to action' (see table ). the odds to prefer the decliners' follow-up were . times higher for caregivers with high self-efficacy ( % confidence interval: . - . ), . times higher when being sceptic of the benefit of the intervention ( % confidence interval: . - . ), . times higher for caregivers who believed in better coping alone ( % confidence interval: . - . ) and . times higher for caregivers supported by family and friends ( % confidence interval . - . ). the purpose of sebt is to provide a short-term intervention with coping strategies to informal caregivers of palliative patients facing the existential situation of disease and bereavement. this randomised controlled trial studied the impact of sebt on depression, anxiety, subjective distress, minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. receiving sebt sessions or supportive psychological sessions was neither significantly associated with the primary outcome of post-treatment depression nor with the secondary outcomes. the outcomes were prevailingly associated with their respective level before the intervention and with the time of investigation, which leads to the assumption that the time passing was the main reason for changes of outcomes over the course of months. caregivers who declined the intervention did not differ significantly from participants of the randomised controlled trial in outcomes at any assessment. in fegg et al'.s randomised controlled trial on ebt, the control participants did not receive a control treatment and instead could decline any support or could choose from the spectrum of available support at the palliative care unit (e.g. physicians, nurses, chaplains, social workers, psychologists and bereavement group), whereas this study included an active control group. it is possible that sebt and control showed no significant difference as both groups received a treatment of similar effectiveness. palliative caregivers' capacities for learning new skills like mindfulness might be limited: they face high emotional distress and the responsibilities palliative caregivers typically take over for the patient (i.e. financial decisions, organisation of follow-up hospice care) additionally to their own duties. fegg et al'.s study provided a group setting which could have facilitated learning the new skill of mindfulness by benefitting from group cohesion, central for beneficial effects in group therapy , or by relieving participants from the personal responsibility to practice. participants in sebt were asked to practice mindfulness by themselves which was possibly too demanding, leading to low compliance to practice and less effectiveness. our aim was to create a short-term ebt intervention that fitted better into informal caregivers' daily lives. we reached our goal of increasing acceptability: . % of all contacted caregivers participated in the randomised controlled trial. shortening ebt and choosing an individual setting tripled the inclusion rate compared with . % in fegg et al'.s study. however, by shortening the intervention, we traded inclusion rate for effectiveness and the intervention was not intensive enough to impact caregivers' psychological state in comparison to the control group. carmody and baer's review about the optimal length of mindfulness based programmes, with participants ranging from healthy to chronically ill participants, did not evidence that shortened versions of mindfulness-based programmes are less effective compared with the standard format of class hours. the authors suggested that adaptations including less class time may be worthwhile for populations for whom a longer time commitment may be a barrier to participate. but how short is too short? the study with the fewest sessions in carmody and baer's review included -weekly -h classes, which is three times more instruction time than in this study. our results lead to the conclusion that the -h sebt version is too short, especially with participants as burdened as palliative caregivers. the optimal length of mindfulness-based interventions for informal caregivers should be investigated further to offer interventions which impact caregivers' psychological status while not overwhelming them. strengths of the study include the randomised controlled design, the high adherence of the therapists to the manual and the embedded decliners' follow-ups which allowed a comparison with trial participants and ensured high external validity. during the study, it became apparent that participants had been assigned to sebt or control group violating the randomisation protocol. recruiting was suspended, all data collected up to this point was carefully checked and affected participants' data were excluded from analysis. in addition, appropriate measures of staff change and staff training were taken. data of caregivers were removed from analysis as they had missing post-intervention data at t or dropped out of the intervention. comparing their pre-intervention data to the other participants, they had higher levels of negative affect and of minor mental disorders which possibly caused them to drop out. this leads to the assumption that the intervention might be too demanding for highly burdened caregivers. profiting of the 'small window' for recruiting caregivers before they become too burdened by care could be facilitated with early integration of palliative care. , early integration of sebt could help caregivers learn new skills to prepare for stressful times ahead. furthermore, sebt could benefit from mixing the settings. sörensen et al. suggested combining group and individual setting to improve caregiver affect in the individual setting and help build social networks in the group. individual sebt could offer immediate support to caregivers, while a following ebt group could yield higher impact on caregivers' psychological morbidity with more class hours and positive influence of group cohesion on motivation and personal practice. ethical approval precludes the data being provided to researchers who have not signed the appropriate confidentiality agreement. these restrictions are as per the ethics committee of ludwig-maximilians university munich which approved the study . in accordance with ethical approval, all results are in aggregated form to maintain confidentiality and privacy. data are held at the department of palliative medicine, munich university hospital, ludwig-maximilians-university, munich, germany. the author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article. the author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: stifterverband für die deutsche wissenschaft e.v. (h ). martina b kühnel https://orcid.org/ - - - supplemental material for this article is available online. eapc task force on family carers white paper on improving support for family carers in palliative care: part a psychoeducational intervention for family caregivers of patients receiving palliative care: a randomized controlled trial the psychological impact of cancer on patients' partners and other key relatives: a review a meta-analytic review of interventions for caregiver distress: recommendations for future research supporting lay carers in end of life care: current gaps and future priorities evaluating the effects of mindfulness-based interventions for informal palliative caregivers: a systematic literature review existential behavioural therapy for informal caregivers of palliative patients: a randomised controlled trial determinants of the effect of existential behavioral therapy for bereaved partners: a qualitative study the feasibility and acceptability of short-term, 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adherence: a systematic review kurzskala zur erfassung allgemeiner selbstwirksamkeitserwartungen (asku) messung der therapieerwartung und therapieevaluation von patienten (pathev) fragebogen zur messung der psychotherapiemotivation (fmp) fragebogen zur psychotherapiemotivation (fptm) -testkonstruktion und gütekriterien statistical principles for clinical trials (ich e ): an introductory note on an international guideline clinical practice guidelines for group psychotherapy a systematic review of therapeutic alliance, group cohesion, empathy, and goal consensus/collaboration in psychotherapeutic interventions in cancer: uncommon factors how long does a mindfulnessbased stress reduction program need to be? a review of class contact hours and effect sizes for psychological distress effects of lowdose mindfulness-based stress reduction (mbsr-ld) on working adults early palliative care for patients with advanced cancer: a cluster-randomised controlled trial integration of palliative care into standard oncology care: asco clinical practice guideline update summary how effective are interventions with caregivers? an updated meta-analysis we thank all caregivers, patients and staff members especially verena zierl, marianne schmidt and sigrid haarmann-doetkotte for their contribution to this study. key: cord- -cjdmqcck authors: lázaro-muñoz, gabriel; torgerson, laura; smith, hadley stevens; pereira, stacey title: perceptions of best practices for return of results in an international survey of psychiatric genetics researchers date: - - journal: eur j hum genet doi: . /s - - - sha: doc_id: cord_uid: cjdmqcck many research sponsors and genetic researchers agree that some medically relevant genetic findings should be offered to participants. the scarcity of research specific to returning genetic results related to psychiatric disorders hinders the ability to develop ethically justified and empirically informed guidelines for responsible return of results for these conditions. we surveyed psychiatric genetics researchers from countries to examine their perceptions of challenges to returning individual results and views about best practices for the process of offering and returning results. most researchers believed that disclosure of results should be delayed if a patient-participant is experiencing significant psychiatric symptoms. respondents felt that there is little research on the impact of returning results to participants with psychiatric disorders and agreed that return of psychiatric genetics results to patient-participants may lead to discrimination by insurance companies or other third parties. almost half of researchers believed results should be returned through a participant’s treating psychiatrist, but many felt that clinicians lack knowledge about how to manage genetic research results. most researchers thought results should be disclosed by genetic counselors or medical geneticists and in person; however, almost half also supported disclosure via telemedicine. this is the first global survey to examine the perspectives of researchers with experience working with this patient population and with these conditions. their perspectives can help inform the development of much-needed guidelines to promote responsible return of results related to psychiatric conditions to patients with psychiatric disorders. guidelines for responsible return of individual genetic research results should be context dependent [ ] [ ] [ ] [ ] [ ] to ensure that return maximizes net benefit and is responsive to the needs and characteristics of the participant populations. given recent advances in identifying genomic correlates of polygenic conditions, such as psychiatric disorders, and the expanded use of more comprehensive singlenucleotide polymorphism (snp) arrays and genome and exome sequencing, psychiatric genetics researchers are increasingly managing questions about whether and how to return individual results to participants [ ] [ ] [ ] . there is an emerging consensus among genetics researchers, including psychiatric geneticists [ ] [ ] [ ] [ ] , and research sponsors that some medically relevant genetic findings should be offered to participants. in addition, most research participants expect that researchers will return medically relevant information to them [ , ] . given the methodological approaches (e.g., genomewide association studies comparing cases and controls) in psychiatric genetics research, a substantial portion of the participant population will have a diagnosis of at least one psychiatric disorder. an important consideration is that cognitive impairments and pathological emotional responses are symptoms of some of these psychiatric disorders [ ] . if present, these symptoms could increase the likelihood of participants misunderstanding the implications of results or having a negative emotional response. there is, however, a dearth of research about the impact of returning results to individuals at risk for psychiatric disorders or who have a psychiatric diagnosis [ ] . one of the few relevant studies found that individuals with depressive symptoms who were told that they were at an increased genetic risk for depression were more likely to believe they were currently experiencing major depression or would experience it in the future ("prognostic pessimism") compared to people with depressive symptoms told they were not at an increased genetic risk for depression [ ] . more research has been done on the psychological and psychosocial impacts of disclosing genetic information to participants from the general population or individuals with other health conditions, such as cancer or heart disease. most of these studies have measured anxiety, depression, or other symptoms of psychological distress in response to receiving predictive genetic information and have typically not found evidence of significant or sustained negative psychological effects [ ] [ ] [ ] . however, some evidence suggests those who may be more prone to psychological distress in response to receiving genetic results may be less likely to enroll in studies that have examined psychological distress [ , , ] . in addition, there has been debate about whether quantitative measure of psychological distress, on which many of these studies have relied for drawing their conclusions, is the best way to assess the emotional impact of this information [ ] . further, several studies have reported other negative impacts of receiving genetic information. for example, in one study, participants from the general population who were told they were at an increased genetic risk for developing depression using a sham genetic test reported more depression symptoms over the previous two weeks than those told they did not have such genetic predisposition [ , ] . in another study, healthy older adults who knew that they were at increased genetic risk for alzheimer's disease (i.e., carriers of the apoe allele) judged their memory as worse on subjective memory scales and performed worse on an objective memory test than individuals who also carry the apoe allele, but were unaware [ ] . empirically informed and ethically justified guidelines for returning genetic research results to patient-participants in psychiatric genetics research are critically needed because this is a quickly expanding field of genetics and return of results is a growing practice in this area (gl-m, unpublished data) [ , ] . furthermore, though there is a lack of data on how patients with psychiatric disorders actually respond to genetic research results, the symptoms that characterize many psychiatric disorders suggest these patients are more likely to experience psychosocial harms in response to receiving results compared to control or "healthy" participants. in addition, some research has found transient psychosocial impacts of returning genetic findings even in individuals with no psychiatric disorders [ ] . to develop these guidelines, the psychiatric genetics researchers' perspectives about how to return results to these patients are essential; these researchers have both the relevant knowledge of what types of results may be discovered, as well as experience with this population. thus, we conducted a survey using a worldwide sampling frame to examine psychiatric genetics researchers' opinions on these and related issues. we report descriptive statistics on researchers' perceptions of best practices for return of individual results in psychiatric genetics research. members of the international society of psychiatric genetics (ispg), the largest international society of psychiatric geneticists, and attendees of ispg's world congress of psychiatric genetics were invited via email or in person to participate in a web-based survey starting july and data collection ended december . the institutional review board at baylor college of medicine approved the study. for those invited via email, reminders were sent up to three times. to increase our response rate, participants were offered a chance to win one of six $ gift cards. the survey was developed based on the extant literature and the results of a previous study in which we (gl-m, sp) interviewed psychiatric genetics researchers from countries about their perspectives toward returning genetic research results to individual participants [ , ] . data were collected with five-point likert items with response options from "strongly disagree" to "strongly agree" with a neutral midpoint ("neither agree nor disagree") with the exception of two items examining respondents' preference regarding which professional should return results and how (modality) results should be returned. preferred professional and preferred modality for returning results were queried in two separate questions by asking respondents to choose their preference from a list of seven professionals and seven modalities. survey instructions stated that questions were about adult case-participants as opposed to adult control participants, unless otherwise specified, and that adult caseparticipants would be referred to as patient-participants. a social scientist (sp) conducted two cognitive interviews [ ] with psychiatric genetics researchers to assess question relevance, readability, face validity, comprehension, and survey length, which led to minor changes. the survey was then tested by ten colleagues who are not in the psychiatric genetics field and piloted with five psychiatric genetics researchers. no changes were necessary based on the pilot. the survey was administered in english using qualtrics and distributed via email or in person using a personalized link. the survey took~ - min to complete. we report response frequencies for each item. likert item data are reported as agree, disagree, and neither agree nor disagree by combining the two responses on each end of the scale (e.g., strongly agree and agree). we also calculated median and interquartile range on full likert scale responses to each survey item. for preferred professional and modality for disclosure of results, we report the percentage of respondents that selected each option. differences in sample sizes reflect missing responses. we invited psychiatric genetics researchers to participate in the survey; individuals opened the link. nine people indicated they did not want to participate. of the people who agreed to participate, did not provide answers to any questions, leaving respondents ( %) for analysis. our final response rate was . % of those invited. participant demographics are reported in table . we received responses from researchers from different countries. approximately half ( %) of researchers were female, % held mds, and % held a phd without an md degree. overall, % reported they were responsible for "overall study design" and % were involved in analysis of genomic samples/data. the majority ( %) reported they used array-based testing (e.g., snp arrays) in their research and many were also using genome ( %) and exome ( %) sequencing and single-gene testing ( %). respondents' roles, type of genetic testing used, disorders examined, and patient populations are shown in table . respondents' perspectives toward challenges to offering to return individual genetic research results related to psychiatric disorders to patient-participants are reported in fig. . additional detail on response distributions is available in supplementary materials and . most researchers ( %) felt that a significant challenge to offering return of results is that patient-participants with psychiatric disorders could have a negative emotional reaction in response to receiving results, and that little research exists about the impact of returning results to these patientparticipants ( %). furthermore, nearly half ( %) of respondents agreed return of results should be delayed if a participant is experiencing significant psychiatric symptoms. the vast majority of researchers ( %) also agreed that patient-participants may misinterpret or misunderstand results. on the other hand, most researchers agreed that practices for returning medically relevant findings should be the same for patient-participants and controls ( %), and the same for results related to psychiatric disorders and nonpsychiatric disorders ( %). most agreed that other significant challenges to returning results are that clinicians lack knowledge and understanding about how to manage results ( %), results generally lack individual-level meaning ( %), and results often lack implications for treatment ( %). ( ) other european countries % ( ) asian countries % ( ) other countries in the americas % ( ) african countries % ( ) other oceania countries . % ( ) academic degree (n = ) a researchers also noted practical and societal challenges. most ( %) agreed that a challenge to returning results is that many studies do not address return of results in their consent forms. in fact, only % of respondents indicated that their own studies' consent forms addressed the issue of whether results would be returned to participants, with an additional % addressing it only in some of their studies' consent forms. most agreed that when obtaining informed consent, it is too difficult for researchers to explain to participants the range of results that could be generated in the study ( %), as well as too difficult for participants to understand that range ( %). a substantial number agreed that it is difficult for researchers to set up the infrastructure necessary to return results ( %), and that it is too expensive to offer return of results ( %). finally, % of researchers agreed that a significant challenge to returning results related to psychiatric disorders is that it could exacerbate mental health stigma, and that it could lead to discrimination by insurance companies and/or other third parties, such as schools and banks ( %). researchers were asked about the process of offering individual genetic research results related to psychiatric disorders to patient-participants. most ( %) agreed that patient-participants should be able to opt out of receiving all results related to psychiatric disorders, and % agreed that participants should be able to opt out of receiving specific types of results related to psychiatric disorders (e.g., medically actionable vs. nonmedically actionable). respondents ( %) also felt that participants should be able to choose whether research results related to psychiatric disorders are included in their medical records. finally, a third of researchers ( %) felt that when using genome/ exome sequencing, psychiatric genetics researchers have a responsibility to look for medically actionable information (e.g., acmg- ) even when it is not the focus of the study, and % agreed that psychiatric genetics researchers have a responsibility to reanalyze genomic data over time and recontact participants if medically relevant findings are discovered. forty percent of respondents agreed that researchers have a responsibility to offer results related to psychiatric disorders discovered incidentally, but many were ambivalent about this, with % selecting neither agree nor disagree. most researchers ( %) agreed that results related to psychiatric disorders should be confirmed by a clinically certified laboratory before being returned to participants. many respondents were unsure or ambivalent about to whom the results should be disclosed. when asked whether results related to psychiatric disorders should be returned directly to participants (or their legal guardian, if applicable), a third of respondents agreed, a third disagreed, and a third selected "neither agree nor disagree." on the other hand, % agreed that results should be returned indirectly through a participant's treating psychiatrist, and a third of respondents selected "neither agree nor disagree." participants were also asked by whom and via what modality they thought medically relevant genetic research results related to psychiatric disorders should be disclosed to participants. respondents were most supportive of results being returned by those with clinical genetics expertise, including a genetic counselor ( % agreed) and a medical geneticist ( %). they were less supportive of results being returned by the patient's treating psychiatrist ( %), a physician researcher ( %), the patient's primary physician ( %), or a nonclinician researcher ( %). when asked which type of professional would be their preferred person to return findings, the majority ( %) selected genetic counselor and % selected medical geneticist (fig. ) . when asked via which modality they thought medically relevant genetic research results related to psychiatric disorders should be returned, the vast majority of respondents ( %) agreed that such results should be returned in person, while % agreed they should be returned via telemedicine (secure video call). researchers were less supportive of other options: % agreed that results should be returned online via a secure website, % via telephone, % via percentage of respondents who agreed/strongly agreed i think a significant challenge to offering to return individual genomic research results related to psychiatric disorders to patient-participants is that... fig. psychiatric genetic researchers' perspectives on challenges to offering to return. results related to psychiatric disorders to patientparticipants. mail, and % via email. when asked to choose which modality would be their preferred method for returning results, % selected in person and far fewer respondents selected each of the remaining options (fig. ). respondents agreed throughout the survey that there is potential for patient-participants to experience negative psychosocial impacts in response to receiving genetic research results related to psychiatric disorders. most researchers believed patient-participants could have negative emotional reactions to results, may misinterpret results, and that there is little research on the impact of returning findings to these participants. though we are unable to determine whether the researchers' concerns were specific to patient-participants with psychiatric disorders, we found previously that psychiatric genetics researchers expressed related concerns and highlighted that they can be especially problematic when working with patient-participants with psychiatric disorders. for example, researchers expressed that in some cases these patient-participants' "cognitive function may not be as good as other people's, so it [could] be very easy to misread the information […]" and that in psychiatric genetics research "we have highly anxious people, we have depressive people. they consistently take information more negatively that they should [ ] ." consistent with these findings, researchers believed that return of results should be delayed if a participant is experiencing significant psychiatric symptoms. importantly, when asked whether return of results practices should be different for patient-participants and control participants, however, researchers disagreed. this suggests that though researchers have concerns about potential negative psychosocial impacts of returning results to patient-participants, either these concerns are not significant enough to merit managing the return of results differently with patients, or they have similar concerns about negative psychosocial impacts to control participants and thus the same level of care should be taken. another potential explanation for why most researchers do not believe patient-participants should be treated differently is that psychiatric genetics researchers are concerned that treating patient-participants differently may perpetuate stigma and undue discrimination that patients with psychiatric disorders often experience [ , ] . most researchers agreed that returning results could lead to discrimination by insurance providers, schools, banks, and other third parties. this could be a reason why most researchers also thought participants should be able to choose whether medically relevant findings should be included in their medical records. once in the medical record, it becomes easier for insurance providers (e.g., life insurance providers) and other third parties to gain access to this information [ ] [ ] [ ] . thus, there is tension between wanting to return results that are medically relevant, but also wanting to protect these patients and possibly control participants from psychosocial harms and potential discrimination. respondents agreed there are a number of practical and structural challenges to responsibly returning psychiatric genetic research results to patient-participants. first, most agreed that one such challenge is that many studies do not address return of results in their consent forms. indeed, many of our respondents reported that their own consent forms did not address return of results, or they were unaware of whether the issue was addressed. this is consistent with other studies that have found that the majority of genetic research consent forms either stated explicitly that genetic results would not be returned or did not address the issue at all [ , ] . current guidelines and best practice standards recommend that the issue of return of results be addressed in genetic research consent forms, and many recommend that research participants be given the option whether they want to receive individual research results at the time of enrollment before such results are discovered [ , , [ ] [ ] [ ] [ ] . in fact, some recommend that results not be returned if the participant has not previously consented to receiving this information. this presents a challenge for studies using biospecimens and data collected without such consent if they identify results they would like to offer to individual participants. in cases where the consent form allows for recontact of participants, researchers may be justified in reaching out to assess interest in receiving results. in other cases, researchers should work with their research ethics committees to assess whether offering results without consent would be justified. ideally, moving forward, researchers should address return of results in their consent forms. respondents also felt that a significant challenge to offering return of results to participants was the difficulty for researchers to explain and for participants to understand the range of results that could be generated. as noted above, guidelines recommend that genetic research participants consent to whether to receive genetic research results at the time of enrollment into these studies. these difficulties in communication and understanding may be barriers to truly informed consent regarding return of results. other research has shown that even when given options for which types of results to receive, research participants may not understand these types of results (e.g., preventable, treatable) in the same way the researchers do and that there is great variability among participants in their conceptualization of these terms [ ] . this highlights the need for more research regarding how potential individual genetic research results could be best communicated to participants. a second practical challenge to returning results that our respondents confirmed was the lack of infrastructure and resources necessary to do so responsibly. these challenges have been a common refrain among researchers and other stakeholders in genetics research alongside the growing consensus to return some medically relevant results to participants. most laboratories may not have the resources or experience contacting participants to return results in a way that minimizes potential emotional harm and ensures participants understand the implications of the findings, a concern our respondents noted [ , ] . accurate interpretation and communication of the results may be particularly important given that most researchers thought a significant challenge when returning results to patient-participants in psychiatric research is that results lack implications for treatment and individual-level meaning. in fact, most laboratories likely do not have clinicians qualified to disclose this information. furthermore, previous research suggests that many psychiatric genetics researchers believe it is important to help ensure that patient-participants whose results reveal or confirm increased risk for a psychiatric disorder have access to care [ ] . the lack of clinicians that could communicate the implications of findings on many projects and concern about follow-up care may explain why an unexpectedly high number of respondents agreed that patient-participant results should be returned through the participant's treating psychiatrist. interestingly, even if the results were returned directly to the treating psychiatrists, most researchers believed that a significant challenge is that clinicians lack knowledge and understanding of how to manage results. finally, most respondents agreed that research results should be confirmed by a clinically certified laboratory before returning them to participants, which represents additional logistical and financial burdens. establishing an infrastructure for returning results to participants that meets researchers' ideal for how this should be done would require significant investments from research sponsors. some have expressed concern that this could divert funds away from research [ ] . however, if research sponsors provide the resources necessary to develop this infrastructure, returning medically relevant psychiatric and nonpsychiatric genomic results would be a way to demonstrate reciprocity for patients' participation by offering information many participants want, as shown in several studies [ , [ ] [ ] [ ] . furthermore, it could increase the societal benefit of investing in psychiatric genetics research and may incentivize participation as many researchers in this field believe (gl-m, unpublished data) [ ] and research has shown [ , [ ] [ ] [ ] . thus, as psychiatric genetics knowledge grows, some patient-participants could benefit directly from these research efforts [ , , ] . the american college of medical genetics and genomics (acmg) recommendation that laboratories should analyze and report "incidental" or secondary findings when conducting genome or exome sequencing in clinical settings generated considerable debate about whether researchers should follow similar practices [ , , ]. an influential article by jarvik et al. argued that researchers have a responsibility to offer to return medically actionable findings and may be ethically and scientifically justified in offering some nonmedically actionable findings, but that participants should be able to opt out of receiving any findings [ ] . psychiatric genetics researchers seem to support this notion. in previous publications, we have reported that the vast majority of psychiatric genetics researchers agree medically actionable findings should be offered to participants, and here we found that most researchers agree participants should have the opportunity to opt out of the return of results and even opt out of the return of specific categories of results (e.g., medically actionable vs. nonmedically actionable) (gl-m, unpublished data) [ , ] . jarvik et al. article, however, maintained that researchers do not have a duty to analyze and offer findings that are not within the scope of the research ("duty to hunt") [ , ] . interestingly, a third of researchers in our sample agreed that they do have a responsibility to look for medically actionable information (e.g., acmg- ) even when it is not the focus of the study. a substantial number of researchers also agreed that they should offer to return results discovered incidentally. furthermore, there has been significant debate about whether researchers and clinicians have a responsibility to reanalyze genomic data and recontact patients or participants if the interpretation of a genomic finding changes in a way that could have medical implications [ , , ] . the general consensus has been that researchers do not have a duty to reanalyze in part due to feasibility constraints once a study's funding has ended [ ] ; however, the american society of human genetics and others have recently expressed support for a limited duty to recontact in the research context [ ] . about a third of researchers in our sample agreed that researchers should reanalyze genomic data over time and recontact participants if medically relevant findings are discovered. respondents felt that if medically relevant genetic research results were to be returned to participants, they should be disclosed by a clinical genetics professional, with most supporting disclosure by genetic counselors. this is consistent with recommendations and research that urges disclosure of genetic research results by a professional who has expertise in both genetics and communication of such information [ , , ] . though this may be the ideal, high costs and shortages of genetic counselors, particularly in some areas of the world, may make this a nonscalable solution for now. further, our respondents were most supportive of returning results in person, which is often noted as ideal yet unrealistic due to issues of limited workforce, efficiency, and cost [ ] . this is also impracticable for those living outside urban settings, where most genetic services are offered [ ] , or in other areas of the world where genetics specialists are in short supply. while studies have found telephone delivery of genetic results to be a tenable alternative to in-person disclosure [ , ] , our respondents were not very supportive of this mode of delivery. in order to meet demand as returning individual results to participants becomes increasingly common, however, other, more scalable options will be necessary. our respondents were more supportive of the use of telemedicine over telephone for returning results, which may reduce burden on both the research and participant side, and therefore maximize the capacity of relevant genetic specialists to return results. it is also important to note that these data were collected before the covid- pandemic, during which many integrated teleconferencing into medical and research practices. this may lead to more acceptance of telemedicine. some challenges will remain, though, including issues around access, privacy, and providing services across jurisdictions. we sampled a diverse group of psychiatric researchers across countries, but results may not be representative of the larger population of psychiatric genetics researchers. because respondents self-selected for participation, it is possible that those with stronger opinions or those who were more familiar with the issue of return of research results may have been more likely to respond. there is also potential for social desirability bias with some survey questions due to the aforementioned emerging consensus in the field that some medically relevant research results should be offered to participants. notwithstanding, this is the first study to assess the perspectives of an international sample of psychiatric genetics researchers on the challenges of and ideal practices for returning results to their participant populations. guidelines for safe and responsible return of genetic research results to participants should be context specific. our findings indicate that many researchers feel that the potential for patient-participants in psychiatric genetics studies to have a negative emotional response or misunderstand results are significant challenges to returning results in this field and that return of results should be delayed if a participant is experiencing significant psychiatric symptoms. respondents also agreed that there are a number of practical and societal challenges. though respondents felt that genetic results should ideally be disclosed by a genetic counselor and in person, they were moderately supportive of other options that may be more scalable, such as telemedicine. given recent advances in psychiatric genetics research alongside an emerging international consensus that some medically relevant genetic research findings should be offered to participants, guidance on how to responsibly return results to this population is critically needed. future research should explore options for maximizing benefit and 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germline mutations in cancer-causing genes identified through research studies should be offered to research participants by genetic counselors my : a web-based tool for self-guided management of genomic test results in research and clinical settings analysis of advantages, limitations, and barriers of genetic counseling service delivery models randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer conflict of interest the authors declare that they have no conflict of interest.publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- -asg qtr authors: beasley, lana o.; ciciolla, lucia; jespersen, jens e.; chiaf, ashleigh l.; schmidt, mallory; shreffler, karina m.; breslin, florence j.; bakhireva, ludmila n.; sanjuan, pilar m.; stephen, julia m.; coles, claire d.; chambers, christina d.; kable, julie a.; leeman, lawrence; singer, lynn t.; zellner, jennifer; morris, amanda s.; croff, julie m. title: best practices for engaging pregnant and postpartum women at risk of substance use in longitudinal research studies: a qualitative examination of participant preferences date: - - journal: advers resil sci doi: . /s - - - sha: doc_id: cord_uid: asg qtr there are significant barriers in engaging pregnant and postpartum women that are considered high-risk (e.g., those experiencing substance use and/or substance use disorders (sud)) into longitudinal research studies. to improve recruitment and retention of this population in studies spanning from the prenatal period to middle childhood, it is imperative to determine ways to improve key research engagement factors. the current manuscript uses a qualitative approach to determine important factors related to recruiting, enrolling, and retaining high-risk pregnant and postpartum women. the current sample included high-risk women who participated in focus groups or individual interviews. all interviews were analyzed to identify broad themes related to engaging high-risk pregnant and parenting women in a -year longitudinal research project. themes were organized into key engagement factors related to the following: ( ) recruitment strategies, ( ) enrollment, and ( ) retention of high-risk pregnant and parenting women in longitudinal research studies. results indicated recruitment strategies related to ideal recruitment locations, material, and who should share research study information with high-risk participants. related to enrollment, key areas disclosed focused on enrollment decision-making, factors that create interest in joining a research project, and barriers to joining a longitudinal research study. with regard to retention, themes focused on supports needed to stay in research, barriers to staying in research, and best ways to stay in contact with high-risk participants. overall, the current qualitative data provide preliminary data that enhance the understanding of a continuum of factors that impact engagement of high-risk pregnant and postpartum women in longitudinal research with current results indicating the need to prioritize recruitment, enrollment, and retention strategies in order to effectively engage vulnerable populations in research. there are significant barriers to recruiting and retaining individuals with overlapping vulnerabilities (i.e., substance use disorders (sud)) in the pregnancy or postpartum period (davis, yao, & bierer, ; mchugh votaw, sugarman, & greenfield ( ) wetherington & roman, ) . this may result in challenges for generalizability and therein create a relatively sparse knowledge base about the long-term outcomes for these women and their children including the environmental, mental health, physiological, and neurological factors. filling these knowledge deficits and gaps requires ongoing assessment because research tools including those for recruitment and retention change; in addition, substance exposures in pregnancy change (e.g., prescription opioid exposure, cannabis use), thereby shifting methods to reach target populations of interest and methods to measure outcomes of interest. it is imperative for the field to identify and address engagement in research, to ensure representation of pregnant and postpartum women that use substances. engagement in longitudinal studies will allow a more complete understanding of maternal and child health outcomes as a result of new and emerging trends in prenatal substance exposure. enhanced understanding of participants' perspectives on engagement and study participation will allow researchers to more fully address this pressing research and public health need. prenatal exposure studies began in earnest in the s, after the identification and diagnosis of fetal alcohol syndrome (jones & smith, ) . careful participant selection and comparison selection were and are necessary to classify effects of prenatal exposures. protectionist and paternalistic regulations (e.g., the national research act of , and federal regulations designating pregnant women as a vulnerable population) excluded women from health research and limited the field's understanding about how sex and gender shape substance use and sud (davis, et al. ; wetherington & roman, ; institute of medicine, ; institute of medicine, a) . research studies on substance exposures during pregnancy expanded rapidly in the past years, in recognition of the cocaine epidemics of the s, and the current increases in prenatal opioid and methamphetamine exposures (gabrhelík, et al. ) . indeed, research that focused specifically on prenatal exposures and other women's health issues has been encouraged by journal editors, policymakers, and funding agencies including the nih helping end addiction longterm (heal) initiative. despite bioethical, legal, and social concerns regarding the risks and benefits of research participation for pregnant and postpartum women who use alcohol and drugs (davis, et al. ) , the inclusion of vulnerable populations who are marginalized or stigmatized in research on sensitive topics has not demonstrated undue harm or exposure to unacceptable risk, and in fact, has been associated with potential benefits, such as altruism, catharsis, and gained knowledge (alexander, pillay, & smith, ) . of course, it is important for researchers to adopt careful experimental design and safeguards that will uphold the principal of non-maleficence and protect vulnerable participants from harm (alexander et al., ; sikeweyiya & jewkes, ) . exclusion of substance using populations may violate important bioethical principles of human subjects research, particularly the principles of autonomy, beneficence, and justice (alexander et al., ) . exclusion from research not only strips individuals from making decisions about their own autonomy and denies them potential benefits of participating, but also exposes them to greater societal marginalization and may ultimately place them at increased risk of harm due to deficits in critical health knowledge and exposure to inappropriate or ineffective treatments (alexander et al., ; johnson et al., ; institute of medicine, b) . unfortunately, prenatal exposures to alcohol, tobacco, and other drugs are rising (substance abuse and mental health services administration, ), with in pregnancies exposed to tobacco ( . %), alcohol consumption ( . %), or illicit drug use ( . %) (ebrahim & gfroerer, ; havens, simmons, shannon, & hansen, ). specifically, opioid exposed pregnancies have increased from . to . per pregnancies (haight, ko, tong, bohm, & callaghan, ). yet, cannabis exposures are the most prevalent drug exposure, with nearly - % reported exposure in the first trimester (alshaarawy & anthony, ) . rising rates of substance exposure correspond to increasing health risks and adverse outcomes at great societal cost and burden to systems of health care and social services, as well as criminal justice. notably, researchers involved in the nida-funded perinatal- treatment research demonstration program that focused on sud treatment for pregnant and postpartum women identified seven clinical factors that contributed to significant difficulty and complexity in the recruitment and retention of women in substance use treatment research, including as follows: ( ) severity of sud, ( ) legal system involvement, ( ) housing instability, ( ) interpersonal relationship challenges, ( ) parenting responsibilities, ( ) employment challenges, and ( ) need for more intensive services. these difficulties with recruitment and retention contribute to additional complications for research, including biased samples of convenience recruited through referrals from social and health agencies, limited sample diversity, deviations from the research design, and ethical issues associated with risk and benefits of participation and involvement with the criminal justice or child welfare system. in particular, when research designs do not involve the possibility of direct benefit due to participation (i.e., observational versus intervention studies), it is important to understand the unique reasons and motivations that drive decision-making about research participation (hallowell et al., ) . due to all of the aforementioned factors that potentially inhibit the inclusion and engagement of high-risk participants (i.e., participants previously or currently using substances), it is imperative to understand the motivations for engagement in research among high-risk participants, focusing specifically on understanding motivation for research participation, factors that influence decision-making about participation, and barriers to participation. the current study reports results from a qualitative research study conducted as part of an -month, multi-site pilot study aimed to develop and demonstrate feasibility of an experimental design for a -year, prospective, longitudinal investigation of normative childhood brain development, beginning in pregnancy. a major aim of the -year study will be to determine factors that alter brain development including prenatal exposure to opioids and other psychoactive substances, as well as other prenatal and childhood environmental exposures. this goal necessitates recruiting pregnant women previously or currently using substances, as well as a large group of pregnant women who are at low risk of prenatal substance use. two of the primary aims of the pilot are ( ) developing and testing recruitment and retention strategies and ( ) addressing ethical and legal challenges of conducting research with a stigmatized and vulnerable population. the current qualitative study is one arm of the -site consortium to improve understanding, from a qualitative perspective, the continuum of engagement of low-and highrisk participants in research. this manuscript focuses on the results of the distinct needs and responses of high-risk participants. specifically, the objectives in this analysis were to address important factors that impact best practices in ( ) promoting longitudinal research to high-risk participants, ( ) enrolling high-risk participants in research, and ( ) retaining high-risk participants in research studies. individual interviews and one focus group were conducted with a total of women (five participated in a focus group). women were at high-risk of prenatal or postnatal substance use and were identified through medical clinics, other research study involvement, or sud treatment programs. recruitment took place across five sites in the usa located in california, georgia, new mexico, ohio, and oklahoma (see table for demographic information). high-risk pregnant and postpartum women were defined in the current study as a parenting or pregnant woman who had used alcohol and tobacco and/or had a current or past history of sud. some participants were currently receiving sud treatment. contact was made through trained research personnel located at each specific site with total participants taking part in the current study (california, n = ; georgia, n = ; new mexico, n = , ohio, n = ; oklahoma, n = ). only one focus group that included five women was combined with the individual interviews. the one focus group was conducted in new mexico prior to group restrictions imposed due to covid- . qualitative methods for the research team, study design, and analysis followed the guidelines recommended by tong, sainsbury, and craig ( ) . qualitative study recruitment began with sites contacting participants in person or by phone and describing the current study and qualitative interview process. all women who expressed interest in participating were scheduled for either a focus group or individual interview depending on whether the interview took place prior to or following covid- restrictions regarding in-person gatherings. interviews conducted during the covid- restrictions were conducted individually by phone. all participants gave oral informed consent. during the consent process, a brief overview of the qualitative study and all safety measures taken to ensure confidentiality were discussed. trained qualitative research assistants collected all qualitative data from march through june . before engaging in focus groups/individual phone interviews, all participants completed an in-person or online survey that included a demographic questionnaire and watched a short video describing the protocols planned for the larger, longitudinal study including neuroimaging (e.g., mri), neurodevelopmental, and biospecimen collection. for the focus group, snacks were provided. participants received a $ - incentive for their participation, and this varied based on site. all focus groups and individual interviews were audio-recorded and lasted approximately - min. transcription work was conducted by qualitative team members or a transcription company, with team members crosschecking all transcripts to verify accuracy. during the transcription process, all identifying information was removed to ensure privacy. all procedures were approved by the sirb for the -site consortium. focus group and individual interview guides for the current project were developed by the first author, in conjunction with the evaluation team and other sites within the research consortium reviewing and revising the guide as needed. focus group and individual interviews were coded individually and combined for data analysis. all coding and data analysis was conducted at one site. recordings were transferred securely according to irb-approved methods. it is important to note that focus group and individual data themes were examined a priori and themes were congruent and therefore data were merged. qualitative data was analyzed using the nvivo © software. five qualitative researchers worked together to develop a codebook focused on broad themes influenced by the semistructured interview guide. thematic analysis was used to define specific themes within the broader categories (braun & clarke, ) . the codebook was developed using an agreed upon coding scheme with themes not being predetermined but rather emerging from the data. upon completion of the codebook, two teams consisting of two qualitative researchers coded all transcriptions using developed coding templates. cleaning of data took place as needed (broader codes enveloping smaller codes). once coded, inter-coder reliability was established using simple percent agreement, which is a commonly used method for assessing reliability in qualitative studies (lombard, snyder-duch, and bracken, ; stemler, ) . average inter-coder reliability was over %. in the "results" section, themes are described in more detail. the validity of the current research findings are enhanced by several design factors such as the calculation of salient factors using percentage of comments and the team-based approach used for coding. specifically, calculating the percentage of comments from participants related to specific themes allowed the research team to ensure that themes discussed in the current paper were saturated or were discussed frequently in focus group/individual interviews. therefore, relying on percent of comments strengthens demonstration of saturation in the current study. further, the majority of qualitative data were collected from individual interviews (n = ) rather than a focus group (n = ), which allows for a more in-depth conversation. specifically, during individual interviews, comments were able to be probed deeply with rich content emerging throughout the qualitative data, rather than simple agreement or disagreement that often emerges from focus group data collection. additionally, the fact that both primary researchers as well as consortium partners were involved in developing the focus group/individual interview guide is a strength, increasing the likelihood that the items on the interview guide validly and comprehensively captured the intent of the research aims. qualitative results for the current study focused on a continuum of engagement of high-risk participants in a multi-year prospective longitudinal, cohort design research study. specifically, themes were organized into key engagement factors related to the following: ( ) promoting research to high-risk participants, ( ) enrollment of high-risk participants in research, and ( ) retention of high-risk participants in a multi-year prospective longitudinal, cohort design research study. key socioeconomic and demographic variables for the study participants are presented in table . the current sample was more racially/ethnically diverse than the general us population, with most participants identifying as white ( %), followed by hispanic/latino ( %), black/african american ( %), multi-racial ( %), american indian ( %), and asian ( %). many participants reported they had never married ( %) with other participants reporting they were currently married ( %), living with a significant other ( %), or divorced ( %). many participants reported completing high school ( %) with an additional % reporting obtaining a ged. the average monthly income was $ . per month (sd = $ . ) and most participants reported receiving some form of government assistance ( %). best ways to promote research studies to high-risk participants participants were asked about the best ways to promote a longitudinal research study to recruit participants and their children into studies with participants explaining the best recruitment locations, ideal individuals to share research study information, and the best type of recruitment material. participants reported that social media is an ideal platform to reach participants ( % of comments). specific social media locations include facebook, instagram, and online mother groups. one participant explained, "a lot of people use social media. so, if it got posted to somebody's account, then you could share it with all of your friends. so, i think that would be great." participants also reported that medical offices ( % of comments) and community/state agencies ( % of comments) were good locations to share information about research studies. an example quote includes: and maybe … when i go to (local agency) for counseling and you know, my mental health needs for me and my kids, therapy anything like that. they always have all kinds of [information] … are you struggling with this, are you interested in this, here's a study to help you earn extra money, are you a single mom, do you have this or that, well then you may qualify for this study that we're doing. other suggested locations included bus stops ( % of comments), billboards ( % of comments), and grocery/ convenience stores ( % of comments). participants also reported that child-friendly locations (i.e., library, parks; % of comments) and educational settings ( % of comments) were good locations to share study information. one participant explained, "maybe flyers at childcare centers and stuff like that, where they have the younger school-aged kids from infant to whatever. i know a lot of moms frequent those places." when participants were asked about locations they would trust the most to receive information, it was disclosed that medical offices such as doctor offices/clinics, state agencies (e.g., women and children food programs, other human services), and educational settings were considered most trustworthy. participants also discussed the type of material they would recommend using to promote research studies with participants explaining they would use commercials ( % of comments), brochures ( % of comments), and radio ( % of comments) to share information about research studies. it was also reported that using news/newspapers ( % of comments), online marketing strategies ( % of comments), and sharing information through word of mouth ( % of comments) would be most effective. in terms of the individuals that would be best to share research study information, participants stated that study information would best come from medical personnel ( % of comments), friends ( % of comments), family members ( % of comments), other participants ( % of comments), and professionals ( % of comments). professionals included counselors/therapists, daycare personnel, clergy, and staff at resources centers. participants were also asked who they would find the most trustworthy in sharing information with them and disclosed doctors ( % of comments), family/other mothers ( % of comments), and friends ( % of comments) would be most trusted. an example quote regarding who participants would trust the most was: …when you think of doctors you think you can trust them more, because they're there to help you take care of your kids or take care of yourself … the doctor isn't going to try to scam you out of something so when you get information from them about a study … you tend to want to read about what they are giving you. research enrollment decision-making participants were asked if any information could be provided during recruitment to help them make the decision of whether or not to enroll in a -year research project that includes data collection from them and their children. the most frequent request for more information involved study procedures ( % of comments). specifically, participants wanted to know more information about data collection, including procedures related to neuroimaging such as magnetic resonance imaging (mris), biosampling, and frequency of procedures. an example quote of wanting more information on study procedures was: …looking at everything that might be required of participants, it seems kind of … a bit invasive and like kind of a large commitment in regards to [sic] coming for mris and sending blood work, the diapers, giving hair, things like that. participants also explained that they wanted to know additional information about the purpose of the study ( % of comments) with participants explaining that they wanted an explanation of the research study in its entirety and how it related to child development. another area that participants explained they needed more information about was study logistics ( % of comments) with participants explaining they would like to know the location of the study and commitment involved with being in the study. in terms of research commitment, one participant shared needing to know "… times and dates to make sure everything is scheduled right … trying to get a couple of days in at the job and … just timing stuff." participants were also asked if there was anyone they would need to speak with to make a decision about enrolling in research involving themselves and their child(ren). participants indicated they would speak to a variety of key individuals, including their significant other or the biological father of the child ( % of comments), family members ( % of comments), and medical personnel ( % of comments). participants reported that several things would make them interested in joining a research study with the most frequent being understanding the research benefits ( % of comments) to others ( % of comments) and themselves ( % of comments). an example quote regarding research benefits to others was: i think if participating contributes to information that can help other moms in the future, if there's more information that can be gained or developed out of this study that can be provided to other moms, before they get pregnant, as they're pregnant, to help in their baby's development. i feel like that's, in some part a small contribution i can make. participants also reported that for research studies that involved their children, there was a strong interest in being provided study results about their children ( % of comments). this included information on brain development and overall child development. one participant explained, "it seemed like something that would be really interesting is to find out more information about your own child …not? just brain development. that's really something that interests me." participants also reported that compensation would impact their interest in joining a research study ( % of comments) with several participants indicating that a potential increase in compensation over time would be attractive. specifically, one participant explained, "i would say maybe increase the compensation as the years go on because … it's hard to stick with a program." barriers to joining a research study participants also discussed barriers to joining a research study. participants reported that a busy schedule ( % of comments) could make it difficult to join a research study. this includes challenges regarding the time commitment for the study and also balancing their work schedule around research study demands. other barriers included transportation difficulties ( % of comments), travel time and location of the study ( % of comments), and having childcare while participating in research activities ( % of comments). many comments from participants regarding barriers were concerns about taking part in a research study. primary concerns included potential risks to the fetus/child ( % of comments) both during pregnancy and after the child is born. one participant explained, "just making sure no harm to the baby … i mean i understand the blood samples but just making sure it's % safe." other concerns included ensuring that participant personal and research information was kept confidential ( % of comments) as well as understanding the invasiveness of biospecimen collection ( % of comments). in terms of confidentiality, an example quote from a participant was: …a reassurance that the information would stay private and … the only thing that made me a little uncomfortable was when you were like "we will have to take your identifying information but then it will be destroyed." i feel like there might be something to substantiate that it's going to be destroyed, and not just a word of mouth thing. supports needed to stay in a research study additional advice was collected from participants regarding what would help them stay in a research study after enrollment. participants reported a variety of research supports that would be helpful to stay in a research project ( % of comments). specific research supports included providing childcare during data collection, compensation for time spent in research, and provision of transportation as needed for families. related to this theme, one participant explained that "… childcare on site is probably a huge one" and another participant reported that "transportation would be very helpful." it was also explained that specific research study logistics are important to consider in supporting participants to stay in a research study ( % of comments). these included receiving regular research updates including the benefits of the study, having well-trained research staff, research staff engaging in regular contact with participants, families being close to the research/data collection site, and families being provided advanced notice of data collection. with regard to receiving research updates, a participant explained: …getting kind of feedback about … here's what you contributed and here's what … we're gonna use … information on what we found, about your baby's development ... for me that would be important. flexibility was another key area of importance for participants ( % of comments). specifically, it was reported that flexibility of the participant schedule, when research appointments are scheduled, and who brings the child to research appointments are important to support ongoing research engagement. an example quote regarding flexibility was: so, i don't know how long an appointment would take. but if appointments could be, quick, able to work around my schedule, flexible, and maybe offer something like what we're doing now (phone interview). if we're not able to meet, like some kind of tele-health option. that would make it so much easier. participants also reported that home visits could potentially increase their ability to stay in a research study ( % of comments) as it would make visits more convenient. it is important to note that some families reported concerns with home visits indicating that not all families feel comfortable with research personnel coming into their home. another theme that emerged included the importance of becoming familiar with research staff ( % of comments) as it creates comfort in staff working with children involved in the research study. participants explained barriers to staying in a research study after enrollment with the most frequent barrier being family-related barriers ( % of comments) including work schedule, family moves, generally busy schedule, lack of childcare, and child(ren) not being interested in the study (when older). with regard to family moves, a participant shared "… it would depend on where i moved and if you guys had the same research study where i moved to." specific research study logistics ( % of comments) were also reported as a potential barrier to staying in a research project with participants explaining barriers related to transportation, time commitment, and frequency of data collection. specific to time commitment/frequency of data collection, one participant explained wanting more information on "how often do you want me to come in? how long are we gonna be there?" best ways to stay in contact with high-risk participants participants were also asked about the best way to stay in contact with participants during a longitudinal research study with participants reporting that collecting contact information from family members is recommended ( % of comments). specific to information important to collect from participants, personal information such as phone number ( % of comments), email ( % of comments), social media information ( % of comments), and home address ( % of comments) were reported as ideal. the current qualitative data describes a continuum of factors that impact engagement of high-risk participants (i.e., those currently or in the past using substances) in a -year complex longitudinal research study. this continuum included factors that impact research promotion strategies, enrollment, and retention of high-risk participants in research studies (see fig. ). recruiting a representative sample of pregnant high-risk participants for a longitudinal study is challenging. however, considering promotion strategies, it is evident that there are a number of avenues whereby researchers may have success both finding and creating contact points with high-risk participants. our findings illustrate how the construct of research promotion is multifaceted. responses from interviews included three major factors: ( ) the location where research material is shared, ( ) the type of material used, and ( ) the person sharing the research material all potentially impact marketing success. considering recruitment locations, participants frequently recommended social media, followed by medical offices, and community/state agencies. in regard to social media, studies have increasingly indicated social media as a key location to gain access to individuals who may be harder to reach, including high-risk individuals (betsch, ; frandsen, walters, & ferguson, ) . additionally, marketing through social media can contribute to reduced recruiting costs, shorter recruiting periods, and better population representation (maloni, przeworski, & damato, ; whitaker, stevelink, & fear, ) . social media has become increasingly common as a major component of research recruitment strategies in recent years (fusar-poli et al., ; whitaker, et al. ) . television commercials, brochures, and radio ads were the three most often recommended mediums. these more traditional marketing methods have been used in research for decades; however, barriers in the use of television and radio advertisements have become more relevant in recent years. for example, many of those who watch television have begun resorting to streaming services. these streaming services often allow users to skip ads, or even remove ads all together. additionally, online radio services with ad-free options have become increasingly common (wlömert & papies, ) . however, although these trends are occurring in the general population, less is known regarding how changes in television and music consumption have changed specifically for pregnant and parenting women with sud. medical personnel, family members, and friends comprised the limited sources for trusted information on research studies for participants. this suggests close interpersonal relationships are important to consider during recruitment. moreover, doctors and nurses may be successfully engaged in the recruitment process where feasible. this is consistent with research newington and metcalfe ( ) showing that forming collaborations with trusted medical professionals aided in both identifying and gaining access to eligible, hard-to-reach participants. adding to support this, when asked who they would trust the most to receive research recruitment information materials from, the most common answer among participants was doctors. the decision to enroll in a long-term research study with few or no direct benefits for participants is complex and multifaceted (hallowell et al., ) . for pregnant and parenting women who use drugs and/or alcohol, the decision can be further complicated by concerns about privacy and safety, logistics related to participation, and details about study procedures and how they relate to child development. the interview and focus group responses from our participants indicated that comprehensive information about specific study procedures and the purpose of the study was most important for informing research participation, with particular interest in understanding the commitment and burden (i.e., time, effort) associated with participation. additionally, almost a third of participants reported concerns about safety and invasiveness of study procedures, particularly the risks to their child, as well as concerns about confidentiality and maintaining the privacy of their personal information. in addition to the concerns about privacy, participants expressed a desire for reassurance that they could trust the research team, and to that end, it was fig. recruitment, enrollment and retention strategies of high-risk participants in research important that study procedures were clearly explained so that they could weigh the risks of participating with potential benefits. this speaks to the importance of autonomy in decisionmaking and informed consent practices, whereby participants' ability to weigh the costs and (potential) benefits of participation and to make the decision for themselves should be valued and respected (alexander et al., ) . interestingly, when participants were asked about factors that would influence motivation to participate in nontherapeutic research, a number of participants spoke about understanding the perceived benefits for others as well as for themselves. consistent with previous research showing that altruism was a key motivator for research participation (alexander et al., ; hallowell et al., ) , current participants indicated that "helping other moms in the future" was an important factor in driving motivation. specifically, participants explained that related to others, they wanted to know more about how research knowledge could support other participants and children as well as how physicians could support young children and families. although altruism has been associated with positive health benefits (post, ) , the indirect benefits of charitable helping, such as positive mood and enhanced meaning, can be difficult to articulate and capture, especially when the help provided does not have a clearly defined beneficiary or observable impact (i.e., helping an unknown other, sikeweyiya & jewkes, ) . notably, altruistic motivation was more likely to occur among participants who were better informed about research generally and what might be gained through research participation at the level of the community or society more broadly (sikeweyiya & jewkes, ) . these findings suggest that altruism is a motivating factor that could be more directly addressed in marketing and informed consent processes, with additional information provided to potential participants about the value of research participation more generally, as well as how participants' specific data will help others, as much as it can be known or anticipated. direct compensation for participating was also identified as an important factor in deciding whether to participate in research. the decision to participate in research is shaped by personal situations and life factors, in particular, money and time. even among participants who reported altruism as a motivating factor, many expected a mutually beneficial interaction that both contributed to the betterment of society and compensated them directly (owen-smith et al., ; sikeweyiya & jewkes, ) . previous research has shown that participants who are older or have financial hardship were more likely to expect a direct material compensation for participation (sikeweyiya & jewkes, ) . if the real costs of study participation are not covered, then study participation can add to an already financially burdened household. in attempting to recruit high-risk or vulnerable populations into research, it is important to consider material compensation as both a motivating factor and a factor that reduces barriers to participation in the context of socioeconomic hardship without introducing undue coercion. a number of participants spoke of concerns about balancing research participation around their work schedules, as well as the costs associated with participation in terms of time, transportation, and childcare. thus, consistent with previous research with vulnerable populations (owen-smith et al., ) , compensation that adequately compensates time (especially if any work needs to be missed or childcare must be obtained), effort, and inconvenience is an important factor for motivating enrollment, with special attention given to unique participant needs and preferences regarding type of incentive (george, duran, & norris, ; owen-smith et al., ) . transportation has also been identified as a barrier in multiple studies involving high-risk families (e.g., mendez, ) , and providing transportation is necessary to ensure a diverse sample. one of the most common threats to internal validity to any longitudinal research is attrition and loss to follow-up bias. therefore, the thoughtful implementation of retention strategies can prove critical for conducting research among highrisk populations (dumka, garza, roosa, & stoerzinger, ) . in regard to such strategies, three major themes emerged when considering how to enhance study retention: ( ) specific supports that can help participants remain in the research study, ( ) barriers to be aware of that can potentially make it difficult to continue study participation, and ( ) the best channels for staying in contact with participants over the course of the study. participants most often reported needs of support in areas of childcare, transportation, and being compensated for their time. these findings align well with previous research, as childcare and transportation needs tend to be more common among vulnerable populations (dilworth-anderson, ; haley et al., a, b) . as such, offering support in terms of transportation assistance and compensation could prove beneficial in terms of retention. additionally, many participants recommended home visits by research staff as a potential solution to transportation and childcare barriers. however, it should be noted that while home visits may aid in reducing potential barriers, a number of participants in the current study voiced that they would not feel comfortable with individuals coming in their home. therefore, prior to the use of home visits, researchers must ensure that families feel comfortable with visits taking place within the home or consider giving participants an option of laboratory-only visits. these options support participant decision-making, a recurring theme among participants. logistical factors mentioned to increase retention included providing participants with regular research updates, advanced notice for study appointments, and a sense of familiarity with research staff. in line with these recommendations, studies that consistently engage with participants via appointment reminders and research updates can foster a sense of anticipation and progress in participants (kim, hickman, gali, orozco, & prochaska, ) . moreover, a number of researcher characteristics can contribute to participant engagement and retention including being well experienced with the services provided/research protocols, flexibility, being nonjudgmental, and being culturally competent (beasley et al., ; o'brien et al., ) . high-risk participants often face a disproportionate number of barriers to remaining engaged in research studies (kim et al., ) . indeed, it has been documented that retention rates for vulnerable families are often mitigated by higher instances of unpredictable negative life events (e.g., car problems, unreliable phone access, eviction) while possessing fewer resources to compensate for them (heinrichs, bertram, kuschel, & hahlweg, ; nicholson et al., ) . additionally, it has been found that low-income, high-risk families tend to move more often than those in elevated ses categories, while also being at a higher risk for experiencing evictions and homelessness (phinney, ) . participants in the current study mentioned barriers related to work schedules, inconsistent daily routines, a lack of childcare, and the potential lack of child interest when children are older. despite these barriers, a number of studies have made attempts to work around some of these issues. for example, studies have been successful in addressing schedule barriers by allowing participants to designate appointment times that would be most convenient for their family (dumka et al., ) , by meeting participants in-person at a hospital or clinic appointment (kim et al., ) or by offering services within the home to reduce transportation and child care needs (fifolt, lanzi, johns, strichik, & preskitt, ) . moreover, it has been found in vulnerable populations that providing childcare and an environment that is child-friendly can ease parents' burden as well and boost young children's motivation and interest in participating (chaffin et al., ; dumka et al., ) . the most common methods for maintaining contact with participants throughout the -year study period that were recommended by participants were personal phone number, email, social media, and home address, in that order. while personal phone numbers can provide the most immediate access to an individual, mobile phone numbers have been found to change more often than other modes of contact, such as email or even social media accounts (haley et al., a, b) . therefore, gathering as many contact modalities as possible, as well as contact information from two close friends or family members, can contribute to better participant tracing and retention rates (haley et al., a, b; nicholson et al., ) . this study may be limited in generalizability by sample demographics. caution should be used in applying the findings of these high-risk participants to all women at-risk of substance use in pregnancy. this study was also limited because the research method changed during the course of the study due to covid restrictions, resulting in the combination of a focus group with individual interviews. in addition, almost half of the women interviewed were from the oklahoma site. findings should be interpreted in light of these limitations. overall, the current study adds vital information to understanding the complexities of marketing, enrollment, and retention strategies when conducting research with participants that are at high risk for substance exposed pregnancies. several key factors proved to be important across a variety of areas related to enrollment and retention. specifically, transportation was found to influence enrollment decision-making, as a barrier to joining a research project and as a support that was needed to stay in a research project. childcare is another area that was reported to impact enrollment and retention. these results indicate the importance of understanding transportation and childcare availability during data collection and to consider ways to support participants in accessing the study location with child supports in place. other key areas that were discussed within enrollment and retention were benefits of the study and compensation. specifically, participants reported that understanding the benefits to self and others was important. these findings indicate the importance of reporting potential benefits and compensation not only when recruiting participants to enroll in a research project, but also to continue this conversation to retain research participants. lastly, across enrollment and retention, busy schedule of participants is an important consideration. leaning on another theme within the retention strategies, it is important to remain flexible with scheduling data collections so that participants are able to work appointments around a potentially chaotic schedule. a potential research barrier in the current study is the possibility that participants might have difficulties in conceptualizing the continuum of engagement in a longitudinal research study without actually being enrolled and experiencing the study. to mediate this barrier, many of the participants in the current study had been involved in other research in an effort to include participants that had some research experience. additionally, answers to qualitative questions were varied and robust which indicates that participants had a wealth of ideas regarding engagement in research. another potential limitation of the current study was that all participants were considered "high-risk." to remediate this limitation, researchers from the current study are currently analyzing qualitative data to determine potential key differences in engaging low-risk versus high-risk participants in longitudinal research. it is important to note that although it was not specifically examined in this study, it is crucial for researchers and staff to be trained in, and understand, culturally competent methods for recruitment, data collection, and retention. this is particularly the case for building trust among researchers and participants from different cultural and high-risk backgrounds. for example, bicultural research staff and bilingual team members are needed, as well as specific training regarding cultural norms and sensitivity (see mendez, ; beasley et al., ) . overall, researchers need to be aware of barriers to enrollment and study engagement strategies for recruiting and retaining high-risk participants in research. future research should focus on understanding further behaviors and techniques in supporting high-risk participants, as engaging this population is essential for understanding developmental trajectories of risk and resilience among children starting already at risk for mental and physical health difficulties. funding this work was supported by the national institute on drug abuse (nida) research grant numbers r da (lob, jmc, and asm) and r da (lnb, js, and ll). conflict of interest the authors declare that they have no conflict of interest. disclaimer the views and opinions expressed in this manuscript 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from spotify's market entry key: cord- - f yfk authors: radu, iulian; tu, ethan; schneider, bertrand title: relationships between body postures and collaborative learning states in an augmented reality study date: - - journal: artificial intelligence in education doi: . / - - - - _ sha: doc_id: cord_uid: f yfk in this paper we explore how kinect body posture sensors can be used to detect group collaboration and learning, in the context of dyad pairs using augmented reality system. we leverage data collected during a study (n = dyads) where participant pairs learned about electromagnetism. using unsupervised machine learning methods on kinect body posture sensor data, we contribute a set of dyad states associated with collaboration quality, attitudes toward physics and learning gains. body postures and gestures are nonverbal communication channels, which have been shown to reveal valuable information about learners' internal states, such as their attitudes towards a learning activity [ ] , misconceptions [ ] , comfort with collaborators [ , ] . additionally, when students collaborate with other students or teachers, the amount of synchronization between their gestures and postures has been linked to collaborative learning dimensions, such as affect [ ] , learning gains [ ] and quality of collaboration [ , ] . in studies involving teachers and students, body synchrony has been linked to increased learning gains [ , ] . however, for some situations body synchrony is negatively correlated with learning. abney et al. [ ] observed dyad movement using computer vision algorithms, and found that synchrony was negatively correlated with learning. another study [ ] , which studied kinect dyad movements, found that body synchronization had no overall effect on any collaborative or learning measures, but found that learning gains were correlated with cycles of "cognition and action", where dyads alternated between reflecting in the activity and interacting with the system. these conflicting results indicate that further research is needed to understand the links between posture and collaborative learning. to perform such research, the traditional method is qualitative coding of video data, which requires large time investment from manual coding. over the last decade, researchers have been investigating how automated methods can be used to detect body postures and their links to student attitudes and learning [ ] . in this paper we expand this research by contributing new methods for analyzing body posture data from kinect sensors, and new understanding of the relationships between posture synchronization and collaborative learning. the goal of this paper is to determine if static postures of paired participants can be used as indicators of group learning, attitudes and collaboration. we perform this investigation in the context of an augmented reality (ar) experience. decreasing costs and advanced body tracking technology make ar popular for educational use [ ] , and it is valuable to understand user behaviors under this context. we use data from a previous study (<anonymized>) where dyads interacted with a homemade speaker system, a common activity in learning physics. dynamic visual representations of the electromagnetic concepts of the speaker are visualized through the ar headset (fig. ). we measured several dependent measures of collaboration, attitudes and learning gains. for this analysis, all variables were measured at the group level. collaboration was measured using a validated rating scheme described by meier, spada and rummel [ ] , measuring collaborative processes on subdimensions such as coordination (i.e. whether participants divided tasks and managed time), information processing (i.e. whether participants shared sharing information and reached consensus), etc. attitudes towards the user experience were measured using the survey instrument in [ ] measuring perception of aesthetics, endurability, focus, novelty, involvement and usability. learning was calculated as relative learning gains (rlg), which measure the amount of knowledge gained between pre and post tests of electromagnetism knowledge. relative learning gains were calculated on the overall test score, as well as on specific subdimensions such as the ability to answer transfer questions. these dependent measures were correlated with dyad participant postures, calculated based on data collected from a microsoft kinect sensor, and from the microsoft hololens headsets worn by participants. through these sensors we collected joint coordinates and gaze data from both participants, and calculated dyad posture metrics such as closeness between participants (which may signal how comfortable participants feel with each other), similarity between spine angles (which may indicate that participants mirror each other's posture), orientation towards peers (which may indicate focus on discussion), forward lean (possibly indicating engagement with the task). participants were recruited from the study pool of a laboratory at a university in the northeastern united states. participation required subjects to not know each other, have no significant prior physics knowledge, be born on/after , speak english fluently, have at least a bachelor's degree, and wear no bifocal glasses. all participants first individually completed a pre-test, then a -min paired activity of answering worksheet questions while interacting with the apparatus, followed by individual post-test. only data from the paired activity was used for analysis. after data cleaning, the resulting dataset contains dyad sessions: sessions with the ar visualizations and sessions without. prior to calculating kinect metrics, the kinect data was preprocessed to remove noise and disambiguate between the seated participants and researcher. we explored k-means posture clustering using the "elbow method", exploring combinations of clustering variables and number of clusters k = , , , . the optimal configuration involved k = clusters and variables of spine synchrony, mean distance between participants, and discussion orientation (fig. left) . figure (right lists the significant correlations found between the time in each cluster and the measures, and fig. shows the video frames at the datapoints that most closely represents each cluster. cluster , what we labeled as "turn takers", are characterized by low spine similarity and positively correlated with coordination and overall collaboration. figure (top left) shows one participant is leaning forward interacting with the setup while the other is watching. this configuration indicates that low spine synchrony could be indicative of a collaboration style where participants take turns interacting with the setup. this is supported by research in [ ] where cycles of leaning forward and backward indicated cycles of reflection and action were found across successful dyads. cluster "open to collaboration", is characterized by low distance between participants and participants facing parallel to each other, and is correlated with overall positive attitudes and learning. figure (top right) shows both participants are sitting close to each other and are engaged in the task in front of them, and left participant in a thinking pose. this configuration appears to show participants highly focused on the task and which would explain a positive correlation with overall attitude and learning. cluster "closed to collaboration", is characterized by high distance between participants and with participants facing each other, and is negatively correlated with overall positive attitudes toward the experience. this clustering configuration seems to be indicative of a more negative experience where participants spend some time facing each other yet remain more distant. the figure above shows a dominant interaction where one participant dominates the activity while the other is sitting back. cluster "synchronized lean", is characterized by high average distance and high spine synchronization, and is negatively correlated with overall coordination. in contrast to cluster , this may indicate the dyad does not spend much time taking turns and that both participants were leaning forward and backward at the same time. in this paper we used unsupervised machine learning methods on body posture sensor data. we detected different posture clusters associated with collaboration and learning, finding these metrics were correlated to dyad posture variables such as spine similarity, distance between peers, and synchronized orientation of participants. we found that when participant spines were not synchronized, the dyad pair tended to show higher levels of coordination. this may indicate that dyads who are good at coordinating tend to take turns, as participants move individually before sharing what they gained from their individual explorations. this result aligns with results from [ ] , where iterating between active and passive states was significantly correlated with learning gains (interpreted as cycling through moments of reflection and action). alternatively, this may indicate participants are individually active at the same time, leading to high levels of individual movement. additionally, dyads who were physically closer to each other throughout the activity had better overall attitudes toward the collaborative task. also, participants who spent more time focused on the activity rather than each other had more positive attitudes. one interpretation is that when people are engaged in the activity, they will be highly focused on the task and enjoying each others' interactions; conversely, participants who are bored will turn to each other to talk more. dyads also communicated better when leaning forward. people who were leaning forward are likely to be more engaged in the activity, and people who are leaning backward are likely to be more disengaged; this is likely to be reflected in their communication. the methodology and findings presented in this paper have larger implications for the learning sciences community, as they can serve to indicate markers of successful and unsuccessful collaborations, possibly applicable to other contexts where dyad pairs are learning through interaction with physical objects, and useful to designing systems that monitor student learning through body posture observations. we acknowledge the potential statistical errors introduced by performing large numbers of correlations due to the exploratory nature of our research. automatic detection of nonverbal behavior predicts learning in dyadic interactions hooks and shifts: a dialectical study of mediated discovery disequilibrium in the mind, disharmony in the body presentation skills estimation based on video and kinect data analysis group rapport: posture sharing as a nonverbal indicator automatically detected nonverbal behavior predicts creativity in collaborating dyads interpersonal synchrony: a survey of evaluation methods across disciplines synchrony and cooperation nonverbal synchrony in psychotherapy: coordinated body movement reflects relationship quality and outcome moving memories: behavioral synchrony and memory for self and others movement dynamics reflect a functional role for weak coupling and role structure in dyadic problem solving unraveling students' interaction around a tangible interface using multimodal learning analytics joint attention: its origins and role in development leveraging mobile eye-trackers to capture joint visual attention in co-located collaborative learning groups augmented reality in education: a meta-review and cross-media analysis experimenting with electromagnetism using augmented reality: impact on flow student experience and educational effectiveness creating interactive physics education books with augmented reality investigating augmented reality support for novice users in circuit prototyping looking inside the wires: understanding museum visitor learning with an augmented circuit exhibit a rating scheme for assessing the quality of computersupported collaboration processes developing and evaluating a reliable measure of user engagement key: cord- - tfvmwyi authors: hoplock, lisa b.; lobchuk, michelle m.; lemoine, jocelyne title: perceptions of an evidence-based empathy mobile app in post-secondary education date: - - journal: educ inf technol (dordr) doi: . /s - - - sha: doc_id: cord_uid: tfvmwyi cognitive empathy (also known as perspective-taking) is an important, teachable, skill. as part of a knowledge translation project, we identified a) interest in an evidence-based cognitive empathy mobile app and b) which faculties believe that cognitive empathy is important for their profession. students (n = ) and instructors/professors (n = ) completed a university-wide survey. participants in education, social work, and the health sciences were among those most interested in the app. the majority of participants said that they would prefer for the app to be free or less than $ for students. most participants preferred a one-time payment option. across faculties, all but one had % or more of its sampled members say that cognitive empathy is important for their profession. results illuminate perceptions of cognitive empathy instruction and technology. results also provide insight into issues to consider when developing and implementing an educational communication app. self-reflecting; hoplock and lobchuk ; vorauer ) , it has been linked to positive outcomes such as increased patient compliance and satisfaction within healthcare (kim et al. ) , engaging in prosocial behavior (davis ) , team effectiveness, and engaging in high quality communication (parker et al. ) . people vary in their ability to engage in cognitive empathy, but fortunately, it is a skill that can be taught (e.g., brunero et al. ; richardson et al. ; teding van berkhout and malouff ) . one way that cognitive empathy can be taught is by using technology (e.g., lobchuk et al. ) . the present research examines people's perceptions of a cognitive empathy-training mobile app as well as how perceptions of cognitive empathy's importance vary by profession. cognitive empathy is studied in a variety of fields, such as healthcare (e.g., blanch-hartigan and ruben ; lobchuk et al. lobchuk et al. , , psychology (e.g., marangoni et al. ; vorauer and sasaki ) , business (e.g., ku et al. ) , and law (e.g., bandes ). one frequently-used paradigm involves filming an interaction between two people, having the interaction members report what they were thinking and feeling throughout the interaction, having the interaction members guess what the other person was thinking and feeling throughout the interaction, and then providing an accuracy score (ickes ) . this accuracy score indicates how accurate a person is at inferring the thoughts and feelings of another. accuracy is associated with relationship satisfaction (sened et al. ; thomas and fletcher ) , skillfully providing social support (verhofstadt et al. ) , and accommodating during conflict (kilpatrick et al. ) . thus, accuracy is helpful for facilitating successful communication and relationships across contexts. people's perspective-taking ability improves when they are self-aware of personal values/emotions that can thwart empathy (lobchuk et al. ) ; receive instruction (lelorain et al. ) and feedback (noordman et al. ) , and self-evaluate with video-feedback (fukkink et al. ). the authors have been conducting iterative research on an intervention that takes these findings into consideration, incorporating ickes' ( ) paradigm and including perspective-taking instruction. however, currently, the intervention involves coming into a lab for the filming. to increase accessibility and cost-effectiveness, the intervention could be adapted as a mobile app for use within any setting, not just the classroom. most students world-wide own a smartphone (e.g., farley et al. ; nason et al. ; o'connor and andrews ; williamson and muckle ) . while mobile devices such as smartphones and tablets (crompton and burke ) are sometimes seen as a distraction in the classroom, they are increasingly being leveraged to facilitate learning (langmia and glass ; nguyen et al. ) . indeed, with classes being forced online due to covid- , it is expected that instructors will incorporate technology into their courses more than ever before (bates ) . it is important that devices are used in a way that facilitates taking an active role in learning (norris et al. ) . when they are used in that way, mobile devices may improve student motivation and productivity (cotter et al. ) , confidence (koohestani et al. ) , and performance (dunleavy et al. ; hsueh et al. ) . for example, a recent metaanalysis of healthcare research on using mobile technology within education (mlearning) found that participants who experienced mlearning tended to have superior knowledge and skills than those who received traditional education (dunleavy et al. ) . thus, growing evidence supports the use of mlearning. we are interested in people's perceptions of using an app for teaching and practicing cognitive empathy. research findings do not always get translated into practice in fields like education, and it can take a long time for them to be implemented if they do (burkhardt and schoenfeld ) . we follow the canadian institutes of health research knowledge to action process (kta; government of canada ) framework to expedite the integration of our evidence-based intervention into students' learning activities. according to this framework, knowledge is created (e.g., through research) and then translated into application through an iterative cycle. knowledge creation includes inquiry, synthesis, and product-creation (government of canada ). we aim to move our research towards the product-creation phase and ensure that it becomes incorporated more quickly into practice. we currently conduct the intervention with students from a variety of healthcare disciplines (e.g., nursing, occupational therapy, kinesiology; (e.g., lobchuk et al. lobchuk et al. , . one version of the intervention has also included videoconferencing (hoplock and lobchuk b ). yet, this intervention could be made more accessible if it were converted to mobile technology. many students and instructors/professors own mobile devices and use apps, making them the ideal population to assess the potential use of mobile learning for educational purposes in an academic setting. it is important to conduct market research with the population of interest (university students and instructors/tenure-track and tenured professors), so that we understand potential app users and the merit of creating the app before we start creating it. we want to ensure that what we create is meaningful to the people who will use it and that it will be used within communication skills curricula. to date, we have conducted intervention research with health professionals. however, it is possible that the potential intervention user-base is larger than just those in the health profession (e.g., law, education, or business). thus, we circulated a university-wide survey to students and instructors/professors to better understand who might be interested in the intervention and cognitive empathy. the purpose of the present research is to identify the target market, demand, and price point as well as to solicit student and instructor/professor perceptions of the empathy-training mobile app. we had the following research questions: this work may appeal to people who study empathy, education technology, marketing, and business. this research may also help people who want to create related apps. cognitive empathy is a valuable skill for successful interpersonal relationships (e.g., batson and ahmad ; davis ; davis ; galinsky et al. ) and so converting a successful intervention to be able to teach empathy accessibly is a worthy goal. after obtaining ethics approval, we conducted a survey to answer our research questions. in accordance with simmons et al. ( simmons et al. ( , , we report how we determined our sample size, all data exclusions, all experimental manipulations (there were none), and all study measures. our aim was to give all students and instructor/professors the opportunity to describe their opinions or attitudes toward our empathy application. a census sampling frame was determined to be most appropriate. this sampling frame aims to collect information from every eligible member of the population. our decision was not to exclude any student or instructor/professor at the university so as to boost our success in accruing a representative sample of students and faculty by taking a census sampling approach. because this work was exploratory, we did not conduct a formal power analysis. instead, we aimed to recruit at least students (hao et al. ) and instructors/professors (vrana ) or as many participants as we could before our stopping rule: complete data collection by the end of december, (approximately month after data collection started). we chose this stopping rule due to time constraints. participation was restricted to students and instructors/professors over the age of . approximately , students and instructors/professors were emailed a survey link; people accessed the survey. data from participants were retained ( students; instructors/professors) after exclusions (n = did not provide consent; n = did not fully complete the survey; one person provided nonsensical responses). most participants identified as white ( % students, % instructors/professors) and as women ( % students, % instructors/professors). the average ages of students and instructors/professors were . years (sd = . ) and . years (sd = . ) respectively. participants volunteered for an online study on "perceptions of an evidence-based empathy mobile app in post-secondary education." at the start of december , they were emailed a study description and link. they were told that they would have until the end of the month to complete the study. a reminder was sent mid-way through the month. participants did not receive compensation. materials can be found on the open science framework: https://osf.io/bh su/?view_only= ff fe e c f d ac f c . the majority of questionnaire items were author-created and inspired by the literature (e.g., alwraikat and tokhaim ; sevillano-garcia and vazquez-cano ; vrana ) . we obtained suitability and coverage feedback on our survey from experts in technology development at the university's technology transfer office. the overall structure of the questionnaire was the same for students and instructors/professors, however the content of the questions varied. students completed questions regarding using the app as part of their education. instructors/professors completed questions regarding using the app as a teaching resource as well as for personal use. after providing informed consent, participants were first presented with a description of the app's purpose and how it would work. they saw two wireframes to give them a sense of the app idea and what the app might look like. next, they were asked their perceptions of the app. students rated their agreement on four statements ( = strongly disagree, = strongly agree), providing their perceptions of the app as being applicable to their profession, their perceptions of the app helping them to meet their needs, their liking using mobile learning as part of their educational curriculum, and their confidence in using mobile technology to achieve their learning goals. instructors/professors were asked to rate their agreement with six similar statements using the same scale. four of the statements related to using the app for teaching or professional work, one related to their perceptions of using mobile technology as an education tool, and one related to their confidence in using mobile technology to achieve their teaching goals. participants then indicated their interest in the app, with faculty indicating both their interest in the app as a teaching tool ( item) and their personal interest in the app ( item; = very disinterested, = very interested). using an open-ended question format, participants provided their reaction to the app (adapted to an open-ended question format from a -pt likert scale from surveymonkey n.d.). they then indicated how likely they would be to consider buying the app ( = extremely unlikely, = extremely likely; adapted from a -pt scale; surveymonkey n.d.). those who selected or on the scale were asked an open-ended question regarding why they were unlikely to consider buying the app. faculty were also asked how likely they would be to recommend that student buy the app ( = extremely unlikely, = extremely likely; adapted from a -pt scale and to this context; surveymonkey n.d.). those who selected or on the scale were asked an open-ended question regarding why they were unlikely to consider recommending buying the app. to better understand price point and pricing strategies, we asked participants to check all that apply when considering what one-time price they would feel comfortable paying for the app ($ . ; $ . -$ . ; $ . -$ . ; $ . -$ . ; over $ . ), what payment type they would prefer (subscription (i.e., several smaller payments); one-time payment (i.e., one larger payment)), and what payment version they would prefer (consumers may choose between a basic version of the in your shoes mobile app that is free and a version that has extra features and a cost; consumers use a free trial of the in your shoes mobile app with extra features and payment is required later). students responded while imagining that the app was required in a course and then responded imagining that the app was not required in a course. instructors/professors were asked what they would feel comfortable asking students to pay if the app was required in a course, and then if it was not required. instructors/ professors were also asked what they themselves would pay if using the app for personal use. participants next completed demographics questions asking about gender, age, ethnicity, income (statistics canada ), smartphone or tablet ownership and use (chen and denoyelles ), device brand (adapted from chen and denoyelles to ask about what brand they primarily use instead of what device they own), hours spent on their phone or tablet for things related to work/school (chen and denoyelles ), whether they use an app for coursework (adapted from chen and denoyelles to ask whether they have used an app instead of how often), their faculty, college, department, and class format (in-person/in-class; online/distance; mix of in-class and online courses). students were asked about their program year, degree, and student status. instructors/ professors were asked their academic rank and teaching experience (the latter was adapted to include more options for those with fewer years of experience; alwraikat and tokhaim ). we also wanted to know if participants' respective programs had at least one course that focuses on interpersonal communication (yes, no, unsure) . those who answered "no" or "unsure" were asked if interpersonal communication was incorporated into their curriculum to some degree. finally, participants rated whether cognitive empathy was important for their profession ( = not at all, = extremely). we employed a descriptive, cross-sectional, online survey with participants. with all students and instructor/professors at the university having been invited to participate, we had the opportunity to 'drill down' and conduct exploratory analyses of linkages between student and instructor/professor characteristics and their opinions or attitudes toward the empathy application. descriptive statistics (medians, means, standard deviations, frequency counts, and percentages) were used to describe the sample of students and instructor/professors, as well as address research questions to . we ran the responses to the open-ended questions through a sentiment analyzer and a word cloud generator located on danielsoper.com to get an objective sense of participants' sentiment towards the product. sentiment analyzers use "computational linguistics and text mining to automatically" determine the overall degree of negativity (− ), neutrality ( ), or positivity ( ) in the text (soper n.d.) . word cloud generators analyze text to determine whether certain words are used more frequently. a strength of these two approaches is that it analyzes the results impartially and, thus, will help validate results found using our other methods. a limitation of these approaches is that they examine the overall text, without nuance. we also analyzed the responses to the open-ended questions using content analysis (see online supplemental materials for additional details; lincoln and guba ; patton ) . credibility was established by recruiting participants from the target population (elo et al. ) . dependability and confirmability were met with an audit trail documenting coding decisions and template development (e.g., saldana ). confirmability also occurred through independent coding and analysis and by an iterative feedback process until consensus was reached (graneheim and lundman ) . we also used participants' own words for codes and themes when possible to ensure that we stayed close to the data (levitt et al. ). there are faculties at the university. at least one student from every faculty participated. instructors/professors from faculties participated. therefore, we obtained diversity in the faculties that participated. over % of participants owned and used a smartphone or tablet, and most participants ( . % students; . % instructors/ professors) used apple products. for students, % have used a mobile app required or suggested by their instructor for course work. for instructors/professors, % have required or suggested to students to use a mobile app for course work. most participants preferred the app to be free ( % of students; % of instructors/professors) or less than $ for students ( % of students; . % of instructors/professors). participants also preferred a one-time payment option ( % of students; % of instructors/professors) as well as the ability to choose between a basic version of the app that is free and a version that has extra features and cost ( % of students; % of instructors/professors; see online supplemental materials for other participant details). addressing research question (who would want to use this app), % of students and % of instructors/professors said that their program features at least one course that focuses on interpersonal communication. of those who said that their program did not feature an interpersonal communication course or that they were not sure if it did, % of students and % of instructors/professors said that interpersonal communication is incorporated into the curriculum to some degree. faculties from where most professors and instructors indicated that they had an interpersonal communication course in their program included business, education, health sciences, law, and social work. instructors/professors from the arts, education, health sciences, and law were among those most interested in using the app as a teaching tool (table ) . instructor/professors from business; education; environment, earth, and resources; and law were interested in using the app for personal use (table ). students in agriculture; art (e.g., fine art); arts (e.g., sociology); education; environment, earth, and resources; health sciences; music; science; social work; extended education; and university (a faculty for those just starting at the university) were interested in the app (table ) . thus, these faculties may be a good target for uptake of the app. when analyzing participants' reactions to the app, one theme that emerged, target or use case, involved commenting on the target people or use case (i.e., when or in what contexts someone might use it) for the app. this theme's categories included that the participant thought the app was not relevant to them; the participant commented on who the target audience might be; and the participant commented on potential use cases for the app (table ) . for example, one participant (woman, instructor/professor, faculty of agricultural and food sciences) wrote, "looks great for areas where you need to communicate with a patient/client on more than one level. not so much in my area." another (man, student, faculty of health sciences) wrote, "the app sounds fun and with right pricing could be helpful to new international students." these responses help narrow the target market. addressing research question (what people from the target population think of the app idea), sentiment analysis and word cloud generator results of the open-ended questions indicated that responses were generally neutral to negative. students' responses to "what is your reaction to the in your shoes mobile app" were neutral ( . ; possible range = − to ). the word cloud indicated that responses were focused ratings were made on a -pt scale with higher numbers indicating greater interest in the app around empathy, apps, and the perception that the idea is interesting (see online supplemental materials for the word clouds). instructor/professor responses were somewhat negative (− . ). their word cloud was somewhat similar to that of the students, but was also focused on students, teaching, and learning. diving deeper, when analyzing participants' reactions to the app, two additional themes emerged: participants described practical issues with the app, which might affect uptake and participants commented on the concept idea (table ). the first theme's categories included barriers to empathy and barriers relating to the intervention procedure. for example, one participant (man, student, university faculty) wrote, "seems like a great idea but would be a little weird to find a partner to record conversations and get them to tag their thoughts and feelings." these responses help identify potential concerns and factors to watch out for when creating the app; for example, finding the right dialogue partner and drawing on a relevant context to engage in a meaningful dialogue. the second theme had four categories: ) positive reactions to the app idea (e.g., favourable evaluation of the app, willingness to try the app, and visualizing positive outcomes as a result of using the app); negative reactions to the app idea (e.g., unfavourable evaluation of the app; doubts in teaching empathy with an app; negative comments about empathy training in general; and comments about the app not practical issues with the app: participant describes barriers to using the app, which might affect uptake barriers to empathy: participant describes barriers that relate to empathy "it seems impractical -a lot of people would probably be very uncomfortable with the exercise described above and would not want to put in the time to tag a recording of their conversation." (woman, student, faculty of arts) procedure: participant describes barriers that relate to the intervention protocol "the instructions are a little complicated, which i believe will prevent some students from using it unless they really want to put in effort. it would be better if scenerios (sic) were supplied in addition to this feature so it didn't require two people to use." (man, student, university ) these responses indicate varying support for the app idea and help clarify the sentiment analysis and word cloud results. participants who indicated that they would be unlikely to buy the app (i.e., they selected or on the question "how likely are you to consider buying the app") were asked about their response. students were understandably somewhat negative given the nature of the question (− . ). their word cloud indicated that responses focused on money, apps, and the word "don't." (e.g., "i don't buy apps"). instructors/professors' responses were unexpectedly positive ( . ). the associated word cloud focused on empathy and technology needing to add value to the course. three themes emerged from qualitative analyses that help us to understand the disinterest in buying the app: ) responses indicating that participants did not think they fit the target market; ) responses about money or purchasing apps in general; and ) responses about the app itself (table ). like the target or use case theme for who would use the app, the first theme's categories included that the app is not relevant or that they lack interest in it. for example, one participant (woman, instructor/professor, faculty of social work) wrote, "i have taught interpersonal communication skills for approximately yearsnot necessary" the second theme's categories included rarely or never spending money on apps; preferring a free app or a free alternative to the app; and that the app would not be a priority purchase (not worth the money). for example, one participant (agender, student, faculty of arts) wrote, "i don't buy apps." another (woman, student, school of business) wrote, "i would only get the app if it had a free trial period to try it out." the third theme's categories related to perceptions of the app's effectiveness and the app's protocol (e.g., the app is impractical, privacy concerns, and confusion about the app's use case or procedure). for example, one participant (man, student, faculty of engineering) wrote, "low chance of repeated use, requires time commitment and analysis." together, these responses provide additional insight into potential concerns, factors to consider when creating the app, and the target market (e.g., offer a free trial, ensure reliable security, promote broad applicability). it is possible that negation within the responses affects scoring as all responses except one included the word "not." thus, responses like "not necessary" may have been interpreted positively. according to the site, "this tool produces an overall sentiment score. although various passages within a sample of text may be particularly positive or negative, the sentiment score produced by this tool considers all of the text in the sample… research shows that in about % of all cases human beings will disagree about the sentiment of written text." (https://www.danielsoper.com/sentimentanalysis/default.aspx) faculty who indicated that they would be unlikely to recommend buying the app (i.e., they selected or on the question "how likely are you to consider recommending buying the app") were asked about their response and (as would be expected given the nature of the question) responses were quite negative (− . ). the word cloud highlighted a focus on the classroom, skill development, empathy, and being unconvinced. three themes emerged from qualitative analyses: ) responses indicating that the app is not relevant to the participant or their field (mirroring responses to being unlikely to buy the app); ) responses indicating skepticism that empathy can be taught with an app (i.e., they are not convinced); and ) responses about money or purchasing apps (table ) . for example, one participant (did not report gender, instructor/ not relevant/no need: participant states that the app is not relevant to them or their field or states disbelief regarding the need for an app to teach empathy (e.g., they say that they are already empathetic) "not appropriate to my area of teaching" (man, instructor/professor, faculty of environment, earth, and resources) lack of interest: participant lacks interest "there would never be a time when i would want to use this. the only way i would ever use it is if were part of a leadership training thing." (man, student, faculty of science) about money: participant makes a comment related to money or purchasing apps rarely or never spend money on apps: participant says that they do not like purchasing apps or that they do so rarely "i never pay for apps" (woman, student, faculty of agriculture and food sciences) free app or free alternative: participant indicates that they would download the app if it were free, otherwise they would prefer a free alternative professor, faculty of arts) wrote, "i don't think they would use it and i'm not sure that i feel that an app is the best approach to learning empathy, so i'm not convinced on its utility." while another (did not report gender, instructor/professor, did not report faculty) wrote, "students have better things to spend their money on, however small the amount." together, these responses provide additional insight into the target market and instructor perceptions of using technology to teach empathy. addressing research question (which professions believe that cognitive empathy is important to their profession), % of students and % of instructors/professors said that cognitive empathy is important for their profession. most participants ( % or higher) from all faculties except one (school of agriculture) thought that cognitive empathy was important for their profession (table ). the present research helps us progress towards the product-creation phase within the kta framework to facilitate uptake of an evidence-based intervention more quickly into the classroom. like other research (farley et al. ; nason et al. ; o'connor and andrews ; williamson and muckle ) over % of participants owned and used a smartphone or tablet. some, but not the majority, of instructors/professors were asking students to use mobile apps for their course work (see also ariel and elishar-malka ) . this amount is likely to increase spurred by the covid- pandemic. we also found that when considering the empathy-based app for class use, qualitative results echoed those found in previous research: participants mentioned usefulness, money, the ability to use a trial version, and enjoyment (kim et al. ). these variables are important because they predict intention to purchase an app (kim et al. ). together, results indicate a potentially large market for apps within higher education and that apps might be successful if perceived as useful, enjoyable, and triable. these findings are timely because there is a worldwide movement in education toward remote learning and using technology to deliver content (e.g., bates ). our research adds to the literature by illuminating perceptions of app cost within education. the majority of participants said that they would prefer for the app to be free or less than $ for students. most participants preferred a one-time payment option. they also preferred the ability to choose between a basic version of the app that is free and a version that has extra features and a cost over a free trial and later payment. qualitative responses indicated that some participants just do not purchase apps. additionally, student participants described being stretched for resources and unable to spend money on apps. apps tend to be free and people often prefer free alternatives to having to pay (hsu and lin ) . thus, making the app free may increase uptake. app developers and marketers should consider making apps free for students and passing the cost on to institutions, when possible (see table for all recommendations). doing so would allow a greater number and diversity of people to learn about concepts such as empathy. apps provide opportunities to advance changes in how content is being taught in and outside of the classroom. currently, when instructors and researchers want to use paradigms like ickes' ( ) , they often require students to come into a lab (e.g., lobchuk et al. ) . this makes participating unfeasible and costly for many. indeed, the present research indicates that cost is top of mind for students. the ubiquity of (lobchuk et al. ) ; receive instruction (lelorain et al. ) and feedback (noordman et al. ) ; and self-evaluate with video-feedback (fukkink et al. ) so that their perspective-taking ability improves. the present research indicates that people recognize the value that a cognitive empathy app can hold and how it can be used. the present research also highlights concerns that people have about using apps for empathy instruction. we found that some people are wary of using their personal devices for recording conversations and being vulnerable. these people might benefit from coming into the lab and participating in a safe experience before using the app, as well as from receiving tips on finding a dialogue partner and drawing on relevant context to engage in a meaningful dialogue. testing to ensure app security and communicating this security to users will also be important as will be ensuring a seamless experience and reducing procedural barriers via usability testing. additionally, our research finds that some people might need to be convinced of the benefits of using technology to teach empathy skills. developing a compelling marketing strategy that demonstrates how mobile devices can improve confidence (koohestani et al. ) and performance (dunleavy et al. ) , and cites evidence of the intervention's effectiveness might be beneficial here. the present research indicates that many people recognize the importance of cognitive empathy for interpersonal relationships and for their profession. convincing them that it can be taught with technology would ensure that more people get the instruction that they need. consistent with previous research (keyworth et al. ) , students want communication skills training. while previous research has studied cognitive empathy within a variety of fields (e.g., teding van berkhout and malouff ), the present research indicates that more fields are interested in it than likely previously thought. participants were interested in the app idea, with those in education, social work, and health sciences among the most interested. even participants in the physical sciences were interested and believed that cognitive empathy is important to their profession despite other research finding that being low in cognitive empathy predicts enrollment in the table key recommendations to develop a mobile empathy app recommendations . make the app free or for a minimal cost to students and pass the cost to institutions, when possible . make the app a one-time payment for students . prioritize targeting people in the fields of business, education, health sciences, and law . empathize the benefits of dialoguing, self-reflection, and actively taking another person's perspective in marketing communications . provide tips on how to find a dialogue partner and draw on relevant context to engage in meaningful dialogue . engage in testing to ensure app security and communicate this security to users . conduct usability testing to ensure a seamless user experience and reduce procedural barriers . develop a compelling marketing strategy that highlights benefits gained across a variety of disciplines as indicated from previous research. developing concrete examples of when the app could be used and including testimonials would be helpful physical sciences (thomson et al. ) . perhaps they are aware of being low and want to improve their perspective-taking skills because they believe it is important for their profession. future research should investigate this further. the confusion and questions about the app protocol as well as the varying sentiment about the app indicates that more research is needed. future research will iterate app descriptions and wireframes to increase clarity and value of the app. scenarios where the app might be used will be guided by research and used in marketing so that the value of the app (e.g., trust-building; blatt et al. ) is evident to a wider range of people. one reason why increasing perceived value will be important is because it predicts app purchase intentions (hsu and lin ) . while the present research was a necessary first step into assessing perceptions of the concept idea, future research will also indicate how perceptions of the app and the idea of using technology to teach cognitive empathy changes as people start interacting with app prototypes. one limitation to this study is participant self-selection bias: the people who opted to participate in a study about empathy may have been more interested in this topic than others. this is evident, for example, in the number of instructors/professors who indicated that they taught courses having to do with interpersonal communication ( %), as well as the greater participation from people who participated in certain fields (i.e., health sciences, education). while we received student participation from every faculty area, this participation was not equal and there was less representation among instructors/professors. it is possible that we would have received a wider variety of responses had participants not known the app's topic (empathy) prior to starting the study. stating that the study focused on an instructional app or an app on communication skills (without mentioning empathy) might have increased the variability. generalizability is also limited because the sample was restricted to one canadian university. future pre-registered research examining perceptions of empathy's importance across disciplines should include a greater number of participants from diverse areas and could examine interest in an empathy app with a non-student population. for example, corporations may have more resources and be more interested in furthering the empathy of their employees than those within educational institutions. additionally, the survey was accessible during a busy month (december), thus people may have been more likely to participate had it occurred in a different month. moreover, the survey contained some adapted and investigator-developed questions that would benefit from additional validation. future research could conduct cognitive interviews to ensure that questions are being interpreted as they were written. despite these limitations, this research has a number of strengths, including the use of multiple methods and analysis techniques (morse ) . our methods allowed us to identify potential barriers to uptake, which is a step in the kta framework (graham et al. ) . potential user feedback spotlighted critical features to incorporate in an empathy app that is designed to foster targeted, meaningful, and efficient learning which can be differentiated based on discipline or profession. additionally, to our knowledge, this is the first study that has examined perceptions of the importance of cognitive empathy across a broad range of fields/professions. our finding that participants in a variety of fields/professions find cognitive empathy important will be of interest to people studying empathy, marketing, and education. taking the perspective of another and understanding where they are coming from is an essential skill for many professions. thus, being able to teach cognitive empathy effectively and accessibly is an important goal for instructors. as impacted by the covid- pandemic, efforts in restructuring how we teach in basic and continuing education are reflective of increasing reliance on technology-based learning. not everyone is enthusiastic about using technology in empathy education. some people are concerned that technology impedes empathy and learning by, for example, acting as a barrier between people. however, we believe that, done correctly, technology can instead act as a bridge. availability of data and material consent was not provided to share non-aggregated data. materials and word clouds are available on the open science framework: https://osf.io/bh su/?view_only= ff fe e c f d ac f c 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published maps and institutional affiliations key: cord- - gpasqtr authors: wild, karoline; breitenbücher, uwe; képes, kálmán; leymann, frank; weder, benjamin title: decentralized cross-organizational application deployment automation: an approach for generating deployment choreographies based on declarative deployment models date: - - journal: advanced information systems engineering doi: . / - - - - _ sha: doc_id: cord_uid: gpasqtr various technologies have been developed to automate the deployment of applications. although most of them are not limited to a specific infrastructure and able to manage multi-cloud applications, they all require a central orchestrator that processes the deployment model and executes all necessary tasks to deploy and orchestrate the application components on the respective infrastructure. however, there are applications in which several organizations, such as different departments or even different companies, participate. due to security concerns, organizations typically do not expose their internal apis to the outside or leave control over application deployments to others. as a result, centralized deployment technologies are not suitable to deploy cross-organizational applications. in this paper, we present a concept for the decentralized cross-organizational application deployment automation. we introduce a global declarative deployment model that describes a composite cross-organizational application, which is split to local parts for each participant. based on the split declarative deployment models, workflows are generated which form the deployment choreography and coordinate the local deployment and cross-organizational data exchange. to validate the practical feasibility, we prototypical implemented a standard-based end-to-end toolchain for the proposed method using tosca and bpel. in recent years various technologies for the automated deployment, configuration, and management of complex applications have been developed. these deployment automation technologies include technologies such as chef, terraform, or ansible to name some of the most popular [ ] . additionally, standards such as the topology and orchestration specification for cloud applications (tosca) [ ] have been developed to ensure portability and interoperability between different environments, e.g., different cloud providers or hypervisors. these deployment automation technologies and standards support a declarative deployment modeling approach [ ] . the deployment is described as declarative deployment model that specifies the desired state of the application by its components and their relations. based on this structural description a respective deployment engine derives the necessary actions to be performed for the deployment. although most of these technologies and standards are not limited to a specific infrastructure and able to manage multi-cloud applications, they all use a central orchestrator for the deployment execution. this central orchestrator processes the declarative deployment model and either forwards the required actions in order to deploy and orchestrate the components to agents, e.g., in the case of chef to the chef clients running on the managed nodes, or executes them directly, e.g., via ssh on a virtual machine (vm), as done by terraform [ ] . however, today's applications often involve multiple participants, which can be different departments in a company or even different companies. especially in industry . the collaboration in the value chain network is of great importance, e.g., for remote maintenance or supply chain support [ ] . all these applications have one thing in common: they are cross-organizational applications that composite distributed components, whereby different participants are responsible for different parts of the application. the deployment and management of such applications cannot be automated by common multi-cloud deployment automation technologies [ ] , since their central orchestrators require access to the internal infrastructure apis of the different participants, e.g., the openstack api of the private cloud, or their credentials, e.g., to login to aws. there are several reasons for the involved participants to disclose where and how exactly the application components are hosted internally: new security issues and potential attacks arose, legal and compliance rules must be followed, and the participant wants to keep the control over the deployment process [ ] . this means that common centralized application deployment automation technologies are not suitable to meet the requirements of new emerging application scenarios that increasingly rely on cross-organizational collaborations. in this paper, we address the following research question: "how can the deployment of composite applications be executed across organizational boundaries involving multiple participants that do not open their infrastructure apis to the outside in a fully automated decentralized manner?" we present a concept for the decentralized cross-organizational application deployment automation that (i) is capable of globally coordinating the entire composite application deployment in a decentralized way while (ii) enabling the involved participants to control their individual parts locally. therefore, we introduce a global multi-participant deployment model describing the composite crossorganizational application, which is split into local parts for each participant. based on the local deployment models a deployment choreography is generated, which is executed in a decentralized manner. based on the tosca and bpel [ ] standards the existing opentosca ecosystem [ ] is extended for the proposed method and validated prototypically. for application deployment automation two general approaches can be distinguished: declarative and imperative deployment modeling approaches [ ] . for our decentralized cross-organizational application deployment automation concept both approaches are combined. most of the deployment automation technologies use deployment models that can be processed by the respective deployment engine. deployment models that specify the actions and their order to be executed, e.g., as it is done by workflows, are called imperative deployment models, deployment models that specify the desired state of an application are called declarative deployment models [ ] . we explain the declarative deployment models in a technology-independent way based on the essential deployment meta model (edmm) that has been derived from investigated deployment technologies in previous work [ ] . the meta model for declarative deployment models presented in sect. is based on the edmm and is the basis for the declarative part of the presented concept. in edmm an application is defined by its components and their relations. for the semantic of these components and relations reusable component and relation types are specified. for example, it can be defined that a web application shall be hosted on an application server and shall be connected to a queue to publish data that are processed by other components. for specifying the configuration of the components properties are defined, e.g., to provide the credentials for the public cloud or to set the name of the database. for instantiating, managing, and terminating components and relations executable artifacts such as shell scripts or services are encapsulated as operations that can be executed to reach the desired state defined by the deployment model. the execution order of the operations is derived from the deployment model by the respective deployment engine [ ] . in contrast, imperative deployment models explicitly specify the actions and their order to be executed to instantiate and manage an application [ ] . actions can be, e.g., to login to a public cloud or to install the war of a web application on an application server. especially for complex applications or custom management behavior imperative deployment models are required, since even if declarative models are intuitive and easy to understand, they do not enable to customize the deployment and management. imperative deployment technologies are, e.g., bpmn tosca [ ] , and general-purpose technologies such as bpel, bpmn [ ], or scripting languages. in general, declarative deployment models are more intuitive but the execution is less customizable, while imperative deployment models are more complex to define but enable full control of the deployment steps. therefore, there are hybrid approaches for using declarative models that are transformed into imperative models to get use of the benefits of both approaches [ ] . in this paper, we follow this hybrid approach by transforming declarative models to imperative choreography models. this means, the user only has to specify the declarative model and, thus, we explain the declarative modeling approach in sect. using a motivating scenario. first, in the next section the meta model for declarative deployment models is introduced. our approach presented in sect. is based on declarative deployment models that are transformed into imperative choreographies. based on edmm and inspired by the declarative application management modeling and notation (dmmn) [ ] , the gentl meta model [ ] , and tosca, a definition of declarative deployment models d ∈ d is introduced: model) . a declarative deployment model d ∈ d is a directed, weighted, and possibly disconnected graph and describes the structure of an application with the required deployment operations: the elements of the tuple d are defined as follows: declarative deployment model specifying all details of the desired application. the notation is based on vino tosca with components as nodes, relations as edges, and the types in brackets [ ] . in addition, sample operations are shown as dots. following the design cycle by wieringa [ ] , we first examined the current situation in various research projects with industrial partners, namely in the projects ic f , sepia.pro , and smartorchestra . with regard to horizontal integration through the value chain network in the context of industry . , we focused on the requirements and challenges of collaboration between different companies [ ] . based on our previous research focus, the deployment and management of applications, the following research problems have emerged: (a) how can the deployment of composite applications across organizational boundaries be automated in a decentralized manner? (b) what is the minimal set of data to be shared between the involved participants to enable the automated decentralized deployment? in fig. queue and database, respectively. in addition, three operations are exemplary shown: a connectsto to establish a connection to the queue, a connectsto to connect to the database, and an install operation to install the jar artifact on the order vm. the other properties and operations are abstracted. assuming that a single organization is responsible for deploying the entire application and has full control over the openstacks and aws, the common deployment automation technologies examined by wurster et al. [ ] fit perfectly. however, in the depicted scenario two participants, p and p , who may be different departments or companies, intend to realize a cross-organizational application so that common deployment automation technologies are no longer applicable. while all participants must agree on the application-specific components, the underlying infrastructure is the responsibility of each participant. for security reasons, participants typically do not provide access to internal apis, share the credentials for aws, or leave the control over deployment to others. to address the research problems, we propose a decentralized concept to enable the cross-organizational application deployment automation ensuring that (i) only as little data as necessary is exchanged between participants and (ii) each participant controls only his or her local deployment while the overall deployment is coordinated. the proposed solution is described in detail in the following section and in sect. the implementation and validation is presented. the motivating scenario in fig. serves as use case for the validation. for the decentralized cross-organizational application deployment automation with multiple participants, it has to be considered that (i) the participants want to exchange as little data as necessary and (ii) each participant controls only his or her local deployment while the global coordination of the deployment of the entire application is ensured. taking these requirements into account, we have developed the deployment concept depicted in fig. . in the first step, the application-specific components are modeled representing the use case to be realized. they typically include the business components such as the order app, storage components such as the database component, and communication components such as the order queue in fig. . in the second step, the global multi-participant deployment model (gdm) is generated, a declarative deployment model containing all publicly visible information that is shared between the participants. this publicly visible information contains also data that must be provided by the respective infrastructure. for example, to execute the operation to establish a connection between order processor and database in fig. , the ip of the database vm is required as input. subgraphs, so called local parts of the gdm, are then assigned to participants responsible for the deployment of the respective components. the gdm is then processed by each participant. first, in step three, for each application-specific component a hosting environment is selected and the adapted model stored as local multi-participant deployment model (ldm). in the motivating scenario in fig. participant p selected aws for the order queue and the openstack for the order app. however, this individual placement decision is not shared. for the deployment execution we use an hybrid approach: based on the ldm a local deployment workflow model is generated in step four that orchestrates the local deployment and cross-organizational information exchange activities. all local workflows form implicitly the deployment choreography which enables the global coordination of the deployment across organizational boundaries. each step is described in detail in the following. in the initial step, the application-specific components representing the use case to be realized have to be modeled. they typically include business components, storage components, and communication components. in the motivating scenario in fig. the set of application-specific components contains the order app, the order queue, the order processor, and the database. in addition, the lifecycle operations, e.g., to install, start, stop, or terminate the components and relations, have to be defined for each of these components and their relations, since all input parameters of these operations must be provided as globally visible information in the gdm. application-specific components are defined as follows: c s ⊆ c d in d, where all r s = (c s , c t ) ∈ r d with {c s , c t } ∈ c s are of type d (r s ) = connectst o and for each c i ∈ c s : cap(type d (c i )) = ∅, to ensure that the application-specific components can be deployed across organizational boundaries, the gdm is generated in the second step which contains the minimal set of necessary information that have to be globally visible, i.e., that have to be shared. thus, the gdm is defined as follows: the elements of the tuple g are defined as follows: -d ∈ d: declarative deployment model that is annotated with participants. -p g ⊆ ℘(Σ + ) × ℘(Σ + ): set of participants with p i = (id , endpoint) ∈ p , whereby Σ + is the set of characters in the ascii table. -participant g : the mapping assigning a component c i ∈ c d to a participant p i ∈ p g participant g : c d → p g . the example in fig. depicts a simplified gdm. the application-specific components, depicted in dark gray, specify requirements, e.g., the order queue requires a message queue middleware. these requirements have to be satisfied by the respective hosting environment. furthermore, for these components as well as their connectsto-relations operations with input parameters are defined. to establish a connection to the order queue the url and q-name of the queue are required. either the target application-specific component provides respective matching properties such as the q-name property exposed by the order queue component or the environment has to provide it such as the input parameter url. for this, in this step placeholder host components are generated that contain all capabilities and properties that have to be exposed by the hosting environment. -for each r j ∈ r d : π (r j ) = c j with type d (r j ) = connectsto and for each operation op r ∈ operations s (r j ) all data elements v r ∈ π (op r ) \ properties s (c j ) are added to properties d (c h ). in the example in fig. the host order queue component provides the capability messagequeue and exposes the property url, which is required as input parameter for the connectsto operations. before the deployment model is processed by each participant, subgraphs of the gdm are assigned to the participants. this subgraph is called local part and indicates who is responsible for this part of the application. this is done by annotating the gdm as shown in fig. on the right. since participants typically do not want to share detailed information about their hosting environment, the gdm is given to each participant for further processing. each participant p i has to select a hosting environment for all c s ∈ c s with participant g (c s ) = p i . in fig. fig. is valid because the property url is covered and the sqs exposes the required capability messagequeue. the substitution is automated by our prototype described in sect. components and matching to existing infrastructure and middleware several approaches exist [ , , ] . soldani et al. [ ] introduced the toscamart method to reuse deployment models to derive models for new applications, hirmer et al. [ ] introduced a component wise completion, and we presented in previous work [ ] how to redistribute a deployment model to different cloud offerings. these approaches use a requirement-capability matching mechanism to select appropriate components. we extended this mechanism to match the properties as well. the resulting local multi-participant deployment model (ldm) is a partially substituted gdm with detailed middleware and infrastructure components for the application-specific components managed by the respective participant. up to this point we follow a purely declarative deployment modeling approach. the core step of our approach is the generation of local deployment workflow models that form the deployment choreography. they are derived from the ldms by each participant and (i) orchestrate all local deployment activities and (ii) coordinate the entire deployment and data exchange to establish crossparticipant relations. while centralized deployment workflows can already be generated [ ] , the global coordination and data exchange are not covered yet. cross-participant relations are of type connectsto and between components managed by different participants. to establish cross-participant relations, the participants have to exchange the input parameters for the respective connectsto-operations. in the example in fig. the relation con establishes a connection from the order processor managed by p to the order queue managed by p . the connectsto-operation requires the url and the q-name as input. both parameters have to be provided by p . since this information is first available during deployment time, this data exchange has to be managed during deployment: for each cross-participant relation a sending and receiving activity is required to exchange the information after the target component is deployed and before the connection is established. in addition, the deployment of the entire application must be ensured. independent which participant initiates the deployment, all other participants have to deploy their parts as well. this is covered by three cases that have to be distinguished for the local deployment workflow generation as conceptually shown in fig. . in the upper part abstracted ldms and in the lower part generated activities from the different participants perspectives are depicted. on the left (a) activities from a crossparticipant relation target perspective, in the middle (b) from a cross-participant relation source perspective, and on the right (c) activities generated to ensure the initiation of the entire deployment are depicted. first, a definition of local deployment workflow models based on the production process definition [ , ] is provided: for each participant p i ∈ p a local deployment workflow model w i based on the ldm is defined as: the elements of the tuple w i are defined as follows: set of control connectors between activities, whereby each e y = (a s , a t ) ∈ e wi represents that a s has to be finished before a t can start. set of data elements, whereby Σ + is the set of characters in the ascii table and v y = (datatype, value) ∈ v wi . -i wi : the mapping assigns to each activity a y ∈ a wi its input parameters and it is called the input container i wi : a wi → ℘(v wi ). -o wi : the mapping assigns to each activity a y ∈ a wi its output parameters and it is called the output container o wi : a wi → ℘(v wi ). -type wi : the mapping assigns each a y ∈ a wi to an activity type, type wi : based on this definition, local deployment workflow models can be generated based on specific rules. in fig. the resulting activities are depicted: (a) for each component c t ∈ c d that is target of a cross-participant relation r c = (c s , c t ) with participant g (c t ) = p i and participant g (c s ) = p j , an activity a t ∈ a wi : type wi (a t ) = invoke is added that invokes the start operation of c t . after a component is started, a connection to it can be established [ ] . thus, a c : type wi (a c ) = send is added to w i that contains all input parameters of the connectsto-operation of r c provided by p i in o wi (a c ). (b) for the component c s ∈ c d , the source of the cross-participant relation r c , an activity a c : type wj (a c ) = receive is add to w j of p j . with the control connector e(a init , a c ) added to w j it is ensured that the activity is activated after the initiate activity of p j . after the input values are received and the start operation of c s is successfully executed, the actual connectstooperation can be executed. (c) each workflow w i starts with the initiate activity a init ∈ a wi : type wi (a init ) = receive. to ensure that after a init is called the entire application deployment is initiated, a notification is sent to all other participants. for each p j ∈ p \ {p i } an activity a n : type wi (a n ) = send with a control connector e(a init , a n ) is added to w i . since each participant notifies all others, for n participants, each participant has to discard n- messages. since the payloads are at most a set of key-value pairs this is not critical. each participant generates a local deployment workflow model, which together implicitly form the deployment choreography. as correlation identifier the gdm id and application instance id are sufficient. while the gdm id is known in advance, the application instance id is generated by the initiating participant. the approach enables a decentralized deployment while each participant controls only his or her deployment and shares only necessary information. to demonstrate the practical feasibility of the approach we extended the tosca-based open-source end-to-end toolchain opentosca [ ] . it consists of a modeling tool winery, a deployment engine opentosca container, and a self-service portal. in tosca, deployment models are modeled as topology templates, the components as node, and the relations as relationship templates with their types. the types define properties, operations, capabilities, and requirements. plans are the imperative part of tosca, for which standard workflow languages such as bpmn or bpel can be used. all tosca elements and executables, implementing operations and components, are packaged as cloud service archive (csar). in fig. the system architecture for two participants is depicted. winery is extended by the placeholder generation and the placeholder substitution. either p or p models the application-specific components and generates the gdm using the placeholder generation that generates node types with the respective properties and capabilities. the resulting gdm is then packaged with the csar im-/exporter and sent to each participant. the substitution mapping detects the local part of managed by the respective participant in the gdm and selects topology templates from the repository to substitute the placeholder host components. the substituted topology template is then uploaded to the opentosca container. the plan builder generates a deployment plan based on the declarative model. we use bpel for the implementation. either p or p can then initiate the deployment. the plan runtime instantiates the plan and invokes the operations. the actual operation, e.g., to create a vm, is executed by the operation runtime. the communication between the opentosca containers is managed by the management bus. the management bus is the participant's endpoint in our setup. however, also arbitrary messaging middleware or any other endpoint that can process the messages can be used. we used the deployment model presented in fig. with two and three participants for the validation. in contrast to general workflow approaches [ , ] , we do not have to deal with splitting workflows according to the participants, since we can completely rely on the declarative deployment model and only implicitly generates a choreography. however, a prerequisite is that each participant only uses the predefined interfaces so that the choreography can be executed. at present, we also limit ourselves to the deployment aspect and do not consider the subsequent management. while management functionalities such as scaling are often covered by the cloud providers themselves, other functionalities such as testing, backups, or updates are not offered. management increases the complexity of automation, especially when local management affects components managed by other participants. we currently only support tosca as a modeling language and opentosca as a deployment engine. so far, we lack the flexibility to support technologies like kubernetes, terraform, or chef, which are often already in use in practice. however, this is part of the planned future work. the research in the field of multi-cloud, federated cloud, and inter-cloud [ , ] focuses on providing unified access to different cloud providers, making placement decisions, migration, and management. all these approaches consider multiple cloud providers satisfying the requirements of a single user. the cloud forms differ in whether the user is aware of using several clouds or not. however, the collaboration between different users each using and controlling his or her environment, whether it is a private, public, or multi-cloud, is not considered, but this is highly important, especially in cross-company scenarios which arose with new emerging use cases in the fourth industrial revolution. arcangeli et al. [ ] examined the characteristics of deployment technologies for distributed applications and also considered the deployment control, whether it is centralized or decentralized. however, also the decentralized approaches with a peer-to-peer approach does not consider the sovereignty of the involved peers and the communication restrictions. in previous work [ ] , we introduced an approach to enable the deployment of parts of an application in environments that restrict incoming communication. however, the control is still held by a central orchestrator. kopp and breitenbücher [ ] motivated that choreographies are essential for distributed deployments. approaches for modeling choreographies, e.g., with bpel [ ] or to split orchestration workflows into multiple workflows [ , ] have been published. however, most of the deployment technologies are based on a declarative deployment models [ ] , since defining the individual tasks to be performed in the correct order to reach a desired state are error-prone. thus, instead of focusing on workflow choreographies we implicitly generated a choreography based on declarative deployment models. breitenbücher et al. [ ] demonstrated how to derive workflows from declarative deployment models. however, their approach only enables to generate orchestration workflows which cannot be used for decentralized cross-organizational deployments. herry et al. [ ] introduced a planning based approach to generate a choreography. however, they especially focus on generating an overall choreography that can be executed by several agents. for us the choreography is only an implicit artifact, since we mainly focus on enabling the cross-organizational deployment by minimizing the globally visible information and obtaining the sovereignty of the participants. in this paper, we presented an approach for the decentralized deployment automation of cross-organizational applications involving multiple participants. a cross-organizational deployment without a central trusted third-party is enabled based on a declarative deployment modeling approach. the approach facilitates that (i) each participant controls the local deployment, while the global deployment is coordinated and (ii) only the minimal set of information is shared. a declarative global multi-participant deployment model that contains all globally visible information is generated and split to local deployment models that are processed by each participant. each participant adapts the local model with internal information and generates an imperative deployment workflow. these workflows form the deployment choreography that coordinates the entire application deployment. we implemented the concept by extending the opentosca ecosystem using tosca and bpel. in future work the data exchange will be optimized since each participant sends notification messages to all other participant and thus for n participants n- messages have to be discarded. we further plan not only to enable multi-participant deployments but also multi-technology deployments by enabling to orchestrate multiple deployment technologies. a gentl approach for cloud application topologies automatic deployment of distributed software systems: definitions and state of the art eine musterbasierte methode zur automatisierung des anwendungsmanagements. dissertation vino tosca: a visual notation for application topologies based on tosca combining declarative and imperative cloud application provisioning based on tosca the opentosca ecosystem -concepts & tools collaborative networks as a core enabler of industry . bpel chor: extending bpel for modeling choreographies declarative vs. imperative: two modeling patterns for the automated deployment of applications inter-cloud architectures and application brokering: taxonomy and survey choreographing configuration changes automatic topology completion of tosca-based cloud applications deployment of distributed applications across public and private networks supporting business process fragmentation while maintaining operational semantics: a bpel perspective e role-based decomposition of business processes using bpel bpmn tosca: a domainspecific language to model management plans for composite applications choreographies are key for distributed cloud application provisioning production workflow: concepts and techniques oasis: web services business process execution language version . ( ) . oasis: tosca simple profile in yaml version . ( ) . omg: bpmn version . . object management group (omg multi-cloud: expectations and current approaches topology splitting and matching for multi-cloud deployments toscamart: a method for adapting and reusing cloud applications a taxonomy and survey of cloud resource orchestration techniques design science methodology for information systems and software engineering the essential deployment metamodel: a systematic review of deployment automation technologies acknowledgments. this work is partially funded by the bmwi project ic f ( ma g), the dfg project distopt ( ), and the dfg's excellence initiative project simtech (exc - ). key: cord- - riu fw authors: alanezi, fahad; aljahdali, anan; alyousef, seham; alrashed, hebah; alshaikh, wyam; mushcab, hayat; alanzi, turki title: implications of public understanding of covid- in saudi arabia for fostering effective communication through awareness framework date: - - journal: front public health doi: . /fpubh. . sha: doc_id: cord_uid: riu fw background: participation of the public is an important and most effective approach for controlling the spread of novel coronavirus. however, considering its novel nature, it is important to create awareness among the public to be able to take timely preventive measures. on the contrary, misinformation and myths from online communities result in severe damages in mitigation of this novel disease. objective: focusing on these aspects, this manuscript reviews public awareness about covid- , myths surrounding it, its symptoms, treatment, transmission, importance of information sources, types of information to be considered in awareness campaigns, promotional channels, and their implications in saudi arabia. methods: an online questionnaire-based survey was used for collecting data related to five major aspects related to covid- and awareness creation process. the survey was accessed by , people, out of whom people participated in the survey. however, dropouts left the survey in between, as a result of which a final sample of was achieved, indicating the response rate of . % and a completion rate of . %. results: awareness levels of the participants related to covid- , its means of transmission, preventive measures, symptoms, and treatment were identified to be moderate to high ( – %). however, reliance on a few myths and violation of certain preventive measures were identified with majority of the participants (more than %). the ministry of health was identified to be the most reliable source of information followed by family and friends. moreover, types of information were identified to be highly relevant and important, which need to be effectively disseminated among the public through effective communication channels. conclusions: lack of awareness can result in serious outcomes in relation to covid- . effective awareness campaigns including relevant information from reliable sources can improve the knowledge of people, and they must be effective in developing positive attitudes among the public toward adopting preventive measures. creating public awareness about infectious diseases which are caused by new pathogens is one of the effective approaches for controlling the spread of diseases such as covid- . as the information about the disease, its symptoms, precautionary methods, diagnosis, and treatment may vary with other infectious diseases and it may take considerable amount of time, it is important for timely updates about the pandemic and the preventive care to be disseminated among the public in order to contain the transmission of infection. lack of public awareness about covid- was observed in different places in the initial days of the pandemic, and people roamed freely without following precautionary methods such as social distancing, and wearing masks ( ) ( ) ( ) . while the nature of the pandemic changes, it is important that the information and advice remain constant. therefore, it is very important that accurate and reliable information must be disseminated to the public through verified sources, and spread of any misinformation must be effectively contained to prevent any loss. therefore, various reliable sources including the world health organization (who) and united nations sister organizations, along with governments of various countries, have been providing regular updates and the necessary information to prevent covid- through various channels ( ) ( ) ( ) . another important factor of creating awareness is to prevent the spread of myths and misinformation. it is evident that perceptions and myths such as drinking raw alcohol can cure covid- by people in iran ( ) , that g towers are the cause for covid- by people in the uk ( ) , and eating garlic or mint can cure covid- , as well as many others ( ) , can lead to serious damage and may increase the chances of contamination. a recent study has identified that there is a positive correlation between the increase in the number of covid- cases and the relative search volumes of terms related to covid- ( ) . in addition, public awareness about covid- varied across sub-regions in different countries, and the immediate need for strengthening the publicity regarding covid- by the governments was identified. however, the concerns about the transmission and the number of infected persons is growing at alarming rates in the past few months compared to other diseases like sars, mers-cov, and influenza. a recent review ( ) of various studies in china and other countries related to covid- has indicated that the reproductive rate (it is an indication of the transmissibility of a virus, representing the average number of new infections generated by an infectious person in a totally naive population) of covid- is very high compared to other infectious diseases. in addition, children and old-aged people are identified to be at high risk of contamination with the novel coronavirus if necessary precautionary methods were not taken. studies have identified that infection was mainly identified in family clusters and workplaces ( ) , reflecting the transmission by direct or close contact in the environment of those with infection. on the other hand, the governments are adopting various approaches ( ) such as containment and mitigation activities to delay the major surges in number of patients and level the demand for healthcare resources such as hospital beds, testing kits, medicines, and other medical equipment and also to protect the most vulnerable from infection, including elderly people and those with health complexities or other critical diseases ( , ) . considering these approaches by the governments, it is important that people are provided with accurate and timely information in relation to these approaches. focusing on the aspect of public awareness, this paper investigates the level of public awareness in saudi arabia and analyzes the types of information to be communicated from the reliable sources and its implications on the public by proposing a conceptual framework. the purpose of this study was to investigate the level of public awareness about covid- in saudi arabia and the importance of information sources, information types, and communication/promotional channels for creating awareness among the people in saudi arabia. as an approach for achieving this objective, an online questionnaire-based survey was adopted. the questionnaire was designed with various aspects related to covid- and level of awareness. it included various sections, including questions related to general awareness of covid- (four items), its symptoms (six items), transmission (three items), preventive care ( items), treatment options (two items), myths (eight items), types of information ( items), communication/promotional channels (nine items), and sources of information (five items). multiple-choice answers and fivepoint likert scale ratings ( ) were used by the participants to answer the questions. the questionnaire was initially designed in english and was then translated to arabic by two professional arabic translators. the arabic version of the questionnaire was designed using questionpro application. a pilot study was conducted with randomly selected people for evaluating the questionnaire. based on the feedback from the pilot study participants, few changes were made in relation to the questions' formulation and grammatical errors in arabic. in addition, cronbach's alpha for all items in the questionnaire was identified to be > . , revealing good consistency and reliability. the general public living in saudi arabia were recruited for the survey using the survey link generated using questionpro application. the survey link was initially forwarded to the general public by posting the link on community groups and other platforms on social media platforms. moreover, the survey was conducted for a period of weeks from march to april . considering the purpose and objective of the study, which was to collect the data from the general population of saudi arabia, the participants were randomly selected. however, the targeted sample population was composed of adults aged years or above. as an approach to reach maximum samples in a short time, snowball sampling technique ( ) was adopted, in which a request is made while forwarding the survey link, whereby participants were requested to forward the message to their friends and colleagues. accordingly, the survey link was initially forwarded to people through various modes. as a result of using snowball sampling technique, the link was accessed by , people, out of which people participated in the survey. however, dropouts were identified who left the survey in between; as a result a final sample of was achieved, indicating a response rate of . % and a completion rate of . %. in addition, the average time taken by the participants to complete the survey was min. the survey was developed using questionpro application and conducted for a period of weeks. the data were analyzed and discussed using four themes, which included sources of information, types of information, communication/promotional channels, and implications of good public awareness. relative frequencies for each item under these themes are used for analyzing the data, which are presented in the following section. the final sample achieved in this study was . the demographic information of the participants is presented in table . among the total participants, . % were male and . % were female. considering the age groups, . % were aged between and years followed by . % between and years, . % between and years, . % between and years, and only participants aged more than years. focusing on the education levels of the participants, . % have bachelor's degrees, followed by . % who have master's degrees, . % have diploma, . % have ph.d., and participants have secondary education. focusing on the professions of the participants, a diverse scenario can be observed with . % government employees, . % private sector employees, . % business professionals, . % students, . % unemployed, and . % retired individuals. majority of the participants belonged to three regions: . % from medina, . % from riyadh, . % from mecca, and . % belonged to other regions of saudi arabia. it is important to note that . % of the participants' educational background (degree education) was not related to healthcare and . % of the participants were not working in healthcarerelated organizations. working in healthcare organizations or having a qualification related to healthcare may increase the possibility that the participants were more aware of the infectious diseases/healthcare aspects compared to other participants. focusing on the general awareness of covid- , majority of the participants, . %, identified incubation period (the time between catching the virus and beginning to have symptoms of the disease) to be ranging from to days, while . % of the participants stated they do not know, and six participants stated days. in addition, . % of participants were aware that covid- is a disease caused by novel coronavirus, and . % of participants believed it was identified in wuhan region, china. while . % of other regions is your education background related to healthcare practices/healthcare management? no are you working in any healthcare related organization? no participants believed that the source of the novel coronavirus is "bats, " . % believed the source is "chinese man;" . % stated that the source is not yet identified. in addition, there are various myths being circulated online, and the participants' awareness levels in relation to these myths are presented in table . the findings reflected that % of the participants believed various myths circulating online, which are not officially confirmed or declared by the governments or healthcare organizations. public awareness about covid- symptoms is presented in table , which has revealed that majority of the participants ( . %) identified fever, dry cough, and breathing difficulties as the general symptoms of covid- , and prolonged illness or symptoms in severe cases as identified by . % of the participants may include pneumonia, acute respiratory syndrome, and organ failure. similarly, public awareness about the transmission risks is presented in table . majority of the participants ( . %) identified different possibilities of transmission by not adopting social distancing measures. in relation to the possibility of cure and treatment, it was acknowledged by . % of the participants that most of the affected persons may recover on their own, and only a small proportion of patients who have severe pre-medical conditions, are old-aged, and are children may need intensive care. it is interesting to note that . % of the participants were aware that people with chronic acute respiratory disease can be severely affected if they are infected with novel coronavirus. in addition, . % of the participants were aware that there is no treatment available for covid- , but about % believed that there is a treatment available, which may be an issue of concern, as they may not seriously adopt preventive measures. focusing on the public awareness of preventive measures, table indicated good awareness levels, as - % of participants acknowledged different preventive measures. however, only . % of the participants stated that they always followed precautionary methods, while . % stated they followed sometimes, and . % stated that they did not follow any precautionary methods. however, . % of the participants believed that quarantine and staying at home is an effective approach toward preventing the spread of novel coronavirus. in addition, only . % of the participants stated that they did not leave home during lockdown/curfew, while . % stated they left home as it was necessary, and . % stated that they left home without any reason. accordingly, . % stated they left home once ( day) a week, . % days per week, . % days per week, . % days per week, . % days per week, and . % days per week; . % stated they did not leave the house. in relation to the reliable sources of information, participants were asked about various sources which they would prefer, and the results are presented in table , which indicates that majority of the participants relied on the ministry of health, friends, and family. in addition, the participants were asked to rate the importance and effectiveness of various types of information which need to be promoted, and the findings are presented in table . although all types of information were important, few types such as access to care, helpline and support, health insurance, and access to medicine were highly important. similarly, participants were asked to rate the importance and effectiveness of various channels/modes of communication, and the responses are presented in table , which indicated online government portals and mobile [calls/sms (short message service)] were identified to be important. the findings related to public awareness have revealed some important aspects related to the information known by the public and the implications especially in adopting preventive measures. in addition, the information flow, reliable sources, types of information, and modes of promotions can be assessed in the context of saudi arabian lifestyle. firstly, focusing on the general awareness about covid- , participants exhibited good understanding about the disease, the pathogen causing the disease, its sources, and the incubation period. though the source of covid- is yet to be identified, there are a considerable number of participants who believed the source of the virus might be bats or transmitted through chinese people. in relation to the awareness about myths circulating online and the truth in them, most of the participants reflected good understanding of the myths, which were verified by the world health organization ( ) and turned out to be false. however, in relation to few myths, there are a considerable number of participants (∼ % of the participants) who believed them to be true, such as using alcohol, hand dryers, and eating garlic can kill the virus. these can have serious outcomes, as it is evident from the recent incidents such as drinking raw alcohol in iran ( ) and burning down g towers in the uk ( ) . therefore, the spread of such myths must be targeted by effectively promoting awareness campaigns through various channels. focusing on the symptoms, participants reflected good understanding, as they stated fever, dry cough, and breathing difficulties as general symptoms which were identified by various reliable organizations ( ) ( ) ( ) . one of the important aspects of covid- awareness is related to the various means of transmission from an infected person. in relation to these factors, most of the participants reflected good understanding, as they identified that the main cause of virus spread is through the droplets released by an infected person through sneezing or coughing, which can rest on different places for a considerable amount of time. however, one of the concerns is that about % of the participants were not aware of these factors. unlike other infections, the importance of awareness and preventive measures is very important in containing the spread of covid- , as there is a high risk of contamination from a single person which can easily lead to the infections across the community or region if proper precautionary methods are not implemented ( , ) . focusing on awareness of preventive measures, participants exhibited good understanding, especially in relation to social distancing, covering mouth and nose while coughing or sneezing, avoiding close contact with symptomatic (flu, cough) persons, and seeking medical help in case the symptoms prolong after incubation period during quarantine. however, other preventive measures such as washing hands regularly and using hand sanitizers were only recognized by ∼ % of the participants. these two approaches are among the important measures which need to be considered on a daily basis to prevent being infected and contain the spread of the virus ( ) . in relation to the reliable sources of information about covid- , majority of the participants relied more on the saudi ministry of health, friends, and relatives than on the recognized bodies such as who and healthcare experts. it is important that the public should rely on reliable sources of information, as unreliable sources increase the chances of contamination and other challenges related to healthcare and social challenges as a result of vast misinformation available on various channels ( , ) . in relation to the types of information to be considered during covid- outbreak, there has been no consensus among the organizations. however, information related to preventive measures, symptoms, and self-care were the most promoted ( , ( ) ( ) ( ) ; there is a need for considering the additional information in order to prevent the spread of mis-information, enable people to manage their activities during lockdown/quarantine, and manage their lifestyles and other aspects such as finance, basic needs, and other necessary aspects. therefore, various types of information were reviewed, and different types of information (presented in table ) were perceived to be highly important by most of the participants. focusing on the channels/modes of promotion, it is essential to consider that information must be disseminated to a large section of the population within a short time, and it is also essential that regular updates can be easily accessed by the public. social media and mobile phones (sms/calls) can be effective in reaching a large section of the population in a short time. therefore, approaches such as passing messages and information about covid- before connecting a call on mobiles by the mobile services companies and daily sms and mobile applications launched by the government to create awareness and track diseases and vulnerability of the users having an infection are proving to be effective in different regions ( ) ( ) ( ) ( ) ( ) . however, majority of the participants preferred online government portals and press releases compared to social media platforms. in addition, mobiles and television were considered by the participants to be effective platforms for creating awareness. it is interesting to note that newspapers were least preferred compared to other channels, as the risk of contamination may be high. by effectively creating public awareness, the spread of covid- can be minimized, and the risk of infections, death, and losses can be prevented. it can also result in effective health outcomes, improve quality of life during lockdowns, survival, and proper planning of work, business and finances, etc. based on these findings, a framework (figure ) for creating public awareness with components including information sources, types of information, communication channels, and the outcomes is formulated especially considering saudi arabian lifestyle. this framework can also be used as conceptual framework for future studies focusing on evaluating public awareness related to pandemics/infectious diseases. there are a few limitations in this study. the first is the methodological approach based on survey questionnaire for collecting and analyzing the public awareness data related to covid- ; a mixed method approach such as observations and interviews could have gathered more qualitative and behavioral data which can be used to analyze the public reactions and lifestyle changes in relation to covid- outbreak. in addition, the survey was conducted over a period of weeks, which could have been increased to achieve a large sample population and response rates. a major limitation of this study is the online questionnaire due to the lockdown situation that reduced the reachability to boarder communities with good sample pool. various implications can be drawn from the study. firstly, this study contributes to the literature by providing the relationship between awareness and self-care practices adopted by the public considering the covid- outbreak, reflecting the people's attitudes toward the pandemic and preventive measures. the findings from the survey can prove to be a valuable source of information for the government, based on which it can update its awareness creation strategies and also tract peoples' attitudes toward the pandemic. in addition, the proposed framework can also be used as a conceptual framework in other research studies focusing on public awareness about pandemic/infectious diseases. this study analyzed the public awareness about covid- , its precautionary measures, and its implications on the lifestyles of the people in saudi arabia. an online survey was conducted, considering the prevailing situation of lockdown to reach maximum participants. a total of respondents participated in this survey. overall, the findings revealed that public awareness about covid- in saudi arabia varied between moderate to high, and its implications reflected that a few measures were not adopted by the public, such as staying at home, which resulted in increased number of positive cases. though they were aware of the precautionary measures of staying at home during lockdowns, most of the participants frequently went out of their homes, which might increase the risk of contamination. therefore, it is very much essential that strict measures and an effective approach for creating awareness are to be adopted, to ensure the success of the lockdown strategy in order to limit the spread of covid- . the original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s. how brazilian favela journalists are raising 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online at the studies involving human participants were reviewed and approved by the institutional review board of the imam abdulrahman bin faisal university. the patients/participants provided their written informed consent to participate in this study. all authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication. key: cord- -jek pd authors: fisher, kimberly a.; bloomstone, sarah j.; walder, jeremy; crawford, sybil; fouayzi, hassan; mazor, kathleen m. title: attitudes toward a potential sars-cov- vaccine: a survey of u.s. adults date: - - journal: ann intern med doi: . /m - sha: doc_id: cord_uid: jek pd background: coronavirus disease (covid- ) has rapidly instigated a global pandemic. vaccine development is proceeding at an unprecedented pace. once available, it will be important to maximize vaccine uptake and coverage. objective: to assess intent to be vaccinated against covid- among a representative sample of adults in the united states and identify predictors of and reasons for vaccine hesitancy. design: cross-sectional survey, fielded from through april . setting: representative sample of adults residing in the united states. participants: approximately adults drawn from the amerispeak probability-based research panel, covering approximately % of the u.s. household population. measurements: intent to be vaccinated against covid- was measured with the question, “when a vaccine for the coronavirus becomes available, will you get vaccinated?” response options were “yes,” “no,” and “not sure.” participants who responded “no” or “not sure” were asked to provide a reason. results: a total of amerispeak panel members responded. overall, . % of participants (n = ) intended to be vaccinated, . % (n = ) were not sure, and . % (n = ) did not intend to be vaccinated. factors independently associated with vaccine hesitancy (a response of “no” or “not sure”) included younger age, black race, lower educational attainment, and not having received the influenza vaccine in the prior year. reasons for vaccine hesitancy included vaccine-specific concerns, a need for more information, antivaccine attitudes or beliefs, and a lack of trust. limitations: participants' intent to be vaccinated was explored before a vaccine was available and when the pandemic was affecting a narrower swath of the united states. questions about specific information or factors that might increase vaccination acceptance were not included. the survey response rate was . %. conclusion: this national survey, conducted during the coronavirus pandemic, revealed that approximately in adults were not sure they would accept vaccination and in did not intend to be vaccinated against covid- . targeted and multipronged efforts will be needed to increase acceptance of a covid- vaccine when one becomes available. primary funding source: agency for healthcare research and quality. c oronavirus disease is caused by the ␤-coronavirus severe acute respiratory syndrome coronavirus (sars-cov- ). this virus has rapidly become a major global threat, instigating a pandemic affecting more than countries and people and leading to nearly deaths worldwide ( ) . the pandemic has overwhelmed hospital systems, undermined economic activity worldwide, and instilled fear into the general populace ( , ) . an international poll conducted in april found that % of those surveyed identified covid- as the most concerning national issue, overtaking unemployment, health care, and poverty ( ) . in a separate survey conducted at the same time in the united states, more than % of participants were very or somewhat concerned about being infected with coronavirus ( ) . in response to the massive global effects of covid- , multiple laboratories worldwide are working to create an effective vaccine. the possibility that one will be available in to months is seen by many as the most promising means of controlling the covid- pandemic. over the past century, vaccinations have become a routine and effective preventive measure in reducing the rate of and eradicating or nearly eradicating certain viral illnesses ( ) . besides providing direct immunity and preventing disease among vaccinated individuals, vaccines have been shown to reduce infections even among individuals who are not vaccinated, through herd immunity, if a sufficient proportion of the population is immune ( ) . many pharmaceutical companies and research labs are currently working with messenger rna, dna, subunit, virus-like particles, and viral vectors to discover an effective vaccine for the covid- pandemic ( , ) . on an unprecedented timeline, multiple vaccines have been developed and are currently being tested in large-scale phase trials ( ) , suggesting that a vaccine may be available in the foreseeable future. the great potential of a vaccine against covid- is tempered by rising vaccine skepticism in the united states and worldwide, which may present challenges to widespread vaccine uptake when a vaccine becomes available ( ) ( ) ( ) ( ) . it is unknown whether the unprecedented and severe effects of covid- in the united states will overcome vaccine skepticism and foster widespread acceptance of and demand for vaccination. we assessed intent to be vaccinated for the novel coronavirus with the question, "when a vaccine for the coronavirus becomes available, will you get vaccinated?" followed by the response options "yes," "no," and "not sure." participants who responded "no" or "not sure" were asked one of the following open-ended questions, respectively: "what makes you unwilling to get the vaccine?" or "what makes you unsure whether you will get the vaccine?." to assess perceived risks of infection, we asked, "what is your best guess as to whether you will get the coronavirus within the next months?"; response options were "i don't think i will get the coronavirus," "i think i will get a mild case of the coronavirus," "i think i will get seriously ill from the coronavirus," or "i have already had the coronavirus." survey items are shown in appendix table (available at annals.org). we conducted rounds of pilot testing of the main question assessing intent to be vaccinated among a convenience sample of over individuals and did not detect any problems. data on participant characteristics were provided by norc and included age, sex, race/ethnicity, educational attainment, household income, household size, marital status, employment status, geographic location, urban or rural location (addresses within a metropolitan statistical area were categorized as urban), receipt of influenza vaccination in the prior year, and self-rated overall health status. norc collects data on healthrelated variables (such as receipt of influenza vaccination and self-rated overall health status) upon enrollment or soon after for most panel members; if a panel member has not responded to a specific item, that item may be included on subsequent surveys. all data provided to the investigators were fully deidentified. participant characteristics were summarized by using frequencies and percentages. we used crosstabulations and tests to estimate unadjusted associations of participant characteristics and perceived personal risk for coronavirus with the -category outcome intent to get vaccinated. to better distinguish characteristics associated with responses of "not sure" versus "yes" and characteristics associated with responses of "no" versus "yes," we also calculated separate tests and associated p values for these sets of comparisons. to estimate corresponding adjusted (multivariate) associations, we used multinomial logistic regression, an extension of binomial logistic regression that compares each of or more nonordered outcome categories to the reference category. in particular, we modeled both natural log [pr (not sure)/pr (yes)] and natural log [pr (no)/pr (yes)] as a function of participant characteristics. this approach allows different associations with covariates for the comparisons while providing overall p values for covariates. whereas coefficients from a binomial logistic regression model are typically exponentiated to obtain odds ratios, exponentiated coefficients from a multinomial logistic regression model are interpreted as relative risk ratios (rrrs). an illustrative calculation is provided in the footnote to table . characteristics that were not statistically significant (p < . ) in the multivariate multinomial modeling were omitted in the final model; these characteristics were found to be correlated with predictors retained in the final model (for example, household income was related to education). we considered the possibility that inclusion of prior receipt of influenza vaccine in the model may obscure other predictors of covid- vaccine hesitancy owing to overlap in the reasons for reluctance to get an influenza or covid- vaccine. we therefore repeated the primary analysis after removing receipt of influenza vaccine from the model. adjusted percentages were calculated for each predictor category by fixing all other predictors at their observed dis- attitudes toward a potential sars cov- vaccine among u.s. adults tributions. to assess model performance, we calculated c-statistics and hosmer-lemeshow statistics separately for binomial logistic regressions for "not sure" versus "yes" and "no" versus "yes." all analyses incorporated survey sampling weights based on gender, age, education, race/ethnicity, and region. analyses were conducted by using sas, version . . we used thematic analysis to inductively generate codes and identify themes in the responses to the open-ended query soliciting reasons for vaccine hesitancy ( ) . the coding team included investigators with backgrounds in health communication, health literacy, patient-provider communication, clinical medicine, and clinical social work; all coding team members had prior experience in qualitative analysis. a coding framework was created on the basis of initial review of all responses. codes and associated definitions were revised and refined through iterative application and discussion. two analysts (k.f., s.b.) then independently coded all responses. more than code could be assigned to a response if applicable. coding discrepancies were discussed until agreement was reached; the third member of the coding team was available to adjudicate but was not needed. codes were assigned in excel; final codes were merged into spss, version , to facilitate data manipulation and summarization. our study was determined to be exempt by the university of massachusetts medical school institutional review board. dr. fisher is supported by agency for healthcare research and quality grant k hs . the funder had no role in the design, conduct, or analysis of this study. the amerispeak omnibus survey was released to panel members, and a total of ( . %) responded. most participants ( . %) completed the survey via the web; the remainder ( . %) completed it via telephone interview. twelve participants did not respond to the question on intent to be vaccinated; all results presented here are based on the participants who responded to this question. a majority of participants ( . %) were white, approximately one third ( . %) were years of age or older, and . % were female. participants had varied levels of educational attainment, with more than one third ( . %) having a high-school diploma or less. most participants perceived their risk for coronavirus to be low, predicting that they will either not get the coronavirus ( . %) or that they will get a mild case of the coronavirus ( . %) in the next months. only participants ( . %) predicted they will get seriously ill from the coronavirus. approximately one half ( . %) of participants reported having received the influenza vaccine previously. additional participant characteristics are shown in table . overall, . % of participants (n = ) intended to be vaccinated, . % (n = ) were not sure whether they would be vaccinated, and . % (n = ) did not intend to be vaccinated. participant characteristics associated with a higher chance of responding "no" or "not sure" versus "yes" were being younger (< years), female, or black or hispanic; having lower educational attainment, lower household income, or larger household size, and being less likely to report having received an influenza vaccine. in addition to these differences, participants who responded "not sure" were more likely to live in the south or west and to believe they were at less personal risk for coronavirus despite providing lower ratings of their overall health. participants who responded "no" were more likely to live in a rural setting ( table ) . after adjustment for differences in participant characteristics ( table ) , factors that were independently associated with vaccine hesitancy (response of "no" or "not sure") include younger age (< years), black race, educational attainment of less than a college degree, and not receiving an influenza vaccine in the prior year. participants who did not have a high school diploma had a nearly -fold higher relative likelihood of responding "no" versus "yes" compared with those who had a college degree or higher (rrr, . [ % ci, . to . ]). black race was associated with a more than -fold higher chance (rrr, . [ci, . to . ]) of not intending to be vaccinated versus intending to be vaccinated compared with white race. participants who had previously received an influenza vaccine had a % lower relative likelihood of responding "no" versus "yes" (rrr, . [ci, . to . ]) compared with those who had not received an influenza vaccine. other characteristics, such as female sex, some age strata, hispanic ethnicity, and perceived personal risk for coronavirus, were associated with vaccination intent but did not consistently achieve statistical significance for both response categories ("not sure" and "no"). living in a rural area was strongly associated with responding "no" when asked about intent to be vaccinated, but not with responding "not sure." household income, household size, region, and self-reported health were not significantly associated with vaccination intent after adjustment for the characteristics in table . results including these as model predictors were similar (data not shown). removal of prior receipt of influenza vaccine from the multinomial model resulted in an increase in the relative risk ratios comparing "no" versus "yes" for age groups ( to years and to years), such that the ci no longer included while other results remained similar (appendix table , available at annals .org). because one of the main goals of our study was to predict who may be hesitant to be vaccinated against covid- and prior receipt of influenza vaccine offers a pragmatic way to identify these individuals, we report the findings from the model that included prior receipt of influenza vaccine. hosmer-lemeshow statistics for "not sure" versus "yes" and for "no" versus "yes" were not statistically significant (p = . and . , respectively), and corresponding c-statistics were . and . , indicating excellent model fit and performance. of the participants who were unsure or did not intend to be vaccinated, ( . %) provided a reason for their response and constitute the sample for the qualitative analysis. the remaining participants who answered "not sure" or "no" ( . %) did not provide a reason for their hesitancy (for example, they did not respond, responded simply "don't know," or provided an uninterpretable response). participants' reasons for being unsure or not intending to be vaccinated are broadly categorized as having specific concerns about the vaccine; needing additional information; holding antivaccine attitudes, beliefs, or emotions; and not trusting entities involved in vaccine development, testing, or dissemination ( table ). the most common reasons cited by participants who were not sure whether they will be vaccinated included specific concerns about the vaccine (such as safety or effectiveness) or a need for more information. in contrast, the most common reasons provided by participants who did not intend to be vaccinated included antivaccine attitudes, beliefs, or emotions, and lack of trust. illustrative quotes are provided in appendix table (available at annals .org). in this large, nationally representative sample, nearly one half ( . %) of participants indicated hesitancy to be vaccinated against covid- when a vaccine becomes available. this finding is especially striking considering that the survey was conducted during mid-april , when the number of deaths per day due to covid- were at or near peak levels of the initial surge in the united states ( ). the percentage of individuals who intend to be vaccinated ( %) is only slightly higher than the percentage of adults who received the influenza vaccination ( %) during the - influenza season ( ); this is surprising, attitudes toward a potential sars cov- vaccine among u.s. adults given the increased severity, death rate, societal disruption, and resultant media coverage associated with the covid- pandemic. increasing vaccination rates are expected to confer substantial benefits, including reductions in covid- related hospitalizations, strain on hospital capacity, and deaths. for example, it has been estimated that increasing influenza vaccination coverage by percentage points could have prevented to hospitalizations in the - influenza season ( ) . the increased severity of covid- compared with influenza suggests that the magnitude of benefit of increased coronavirus vaccination coverage could be even greater. the percentage of individuals who will need to be vaccinated to achieve herd protection is not yet defined for covid- because it depends on vaccine effectiveness, patterns of population mixing, vaccination patterns, and the basic reproduction number (r ) ( ) of the novel coronavirus. using a pooled estimate of the r of . ( ) and assuming a best-case scenario in which a vaccine has perfect effectiveness yields a projection that at least % of the population will need to be vaccinated to achieve herd protection. in fact, a newly developed coronavirus vaccine is unlikely to be perfectly effective, so the coverage required to achieve herd immunity will almost certainly be higher than %. considering that intent as assessed in our study does not account for incomplete followthrough and barriers to vaccine access, it is likely that a substantial gap will exist in the number needed to be vac- attitudes toward a potential sars cov- vaccine among u.s. adults cinated to achieve herd protection and the number who receive vaccination. concerted efforts will be needed to persuade the large percentage of individuals who are unsure about or opposed to being vaccinated against covid- if we are to realize the substantial benefits afforded by high immunization coverage rates. we found several independent predictors of being hesitant to be vaccinated against covid- ; the strongest were lower educational attainment, black race, not having had a recent influenza vaccination, and perceived personal risk for coronavirus, consistent with the findings of a national survey conducted by rti ( ) . evidence that these characteristics are predictive of vaccine hesitancy could be useful in targeting vaccine messaging and outreach to populations at risk for not being vaccinated. our findings highlight the importance of social determinants of health, such as educational status (a close proxy for health literacy [ ] ) and race/ethnicity, and their influence on preventive health behaviors ( ) . racial disparities in vaccination rates have been described for other vaccinations. for example, rates of influenza vaccination among african american persons ( . %) and hispanic persons ( . %) were substantially lower than among white persons ( . ) during - ( ). these differences are particularly concerning given the disproportionately high toll of covid- among african american communities ( - ). the confluence of increased covid- disease burden and potential for decreased receipt of vaccination has the potential to substantially magnify health-related disparities experienced by african american persons. our findings highlight the need for vaccine implementation strategies that anticipate racial gaps in covid- vaccination. these strategies could draw on the approaches used to successfully close racial disparities in measles vaccination while being mindful of persistently lower rates of influenza vaccination rates among minority adults stemming from lack of trust in health care ( ) . prior research has demonstrated the importance of social norms and perceived disease risk in influencing vaccination decisions among african american persons and could be explored as a means of fostering coronavirus vaccine acceptance among this population ( , ) . the association between intent to be vaccinated and perceived risk for coronavirus suggests this may be a particularly important lever for promoting vaccination. in addition to being targeted for populations least likely to be vaccinated, such as members of racial and attitudes toward a potential sars cov- vaccine among u.s. adults annals.org annals of internal medicine ethnic minority groups and individuals of low health literacy, successful vaccination campaigns will need to leverage an understanding of why individuals may be hesitant to be vaccinated in order to tailor messaging to mitigate these concerns. concern about vaccine safety was one of the most commonly cited reasons for being unsure about accepting vaccination in the present study, consistent with studies of other vaccines ( ). a reuters poll found that approximately % of americans would agree to be vaccinated against covid- if they received assurances about the safety of the vaccine ( ). collectively, these findings suggest that transparent reporting of vaccine safety in a way that people of all educational levels can understand is likely to be an effective strategy to increase public uptake of vaccination. however, many participants in our study and the reuters poll indicated hesitancy to be among the first to be vaccinated, which will probably delay achievement of high vaccination coverage rates for covid- . over one half ( . %) of respondents who provided a reason for not intending to be vaccinated referred to antivaccine attitudes, beliefs, or emotions. of these, many indicated only that they did not like, want, or believe in vaccines, whereas others made explicit reference to scientifically inaccurate information, such as the association between vaccines and autism and that it is not possible to vaccinate against a virus. these beliefs and essentially emotional responses to vaccination are likely to be among the hardest to overcome, because information alone is unlikely to have an effect. it may be that messages designed to engage and influence emotions, such as narratives or stories, will be more effective than expository or informational health messages ( ). lack of trust was the second most common reason for responding "no" to intent to be vaccinated. trust has been shown to be a determinant of vaccine uptake ( ), suggesting this finding is likely to be of consequence and indicating a need for strategies aimed at increasing trust among individuals with greater degrees of vaccine skepticism. we found that circulating conspiracy theories about the coronavirus vaccination have taken hold among a small percentage of participants, in addition to more common misconceptions about vaccines. further research is needed to develop effective strategies to combat conspiracy theories and misinformation ( ). some participants in our study also cited prior experience with the influenza vaccine "not working" as a reason to believe a vaccine against the coronavirus will not be effective, demonstrating the negative effects of perceived ineffective vaccines on overall vaccine acceptance. given the real possibility for variable rates of effectiveness among the covid- vaccines currently in development and the possible need for revaccination, public health officials might consider proactively acknowledging this possibility to avoid further loss of trust if or when this happens. surprisingly, very few vaccine-hesitant participants indicated a need or desire for a recommendation from a physician. however, there is evidence that patients whose physicians recommend a vaccine are more likely to be vaccinated than patients who do not ( ). it has been argued that physicians are well-positioned to address misinformation, discuss risk, and convey the seriousness of covid- in a way that is tailored to the unique needs of the individual patient during an encounter ( ). such conversations may be the ideal but may be difficult to implement in time-limited primary care encounters, where there are typically many competing priorities. in addition, the effectiveness of such conversations will almost certainly depend on the patient having trust in the physician and the physician having the requisite time, skills, and comfort to address the emotion-laden topic of vaccine hesitancy. given the time constraints of primary care and the potential need for physicians to receive additional training to enable them to successfully address vaccine-related concerns, health systems might consider an alternative strategy in which trained vaccine counselors use motivational interviewing to engage vaccine-hesitant individuals. this approach has been effective at increasing rates of infant vaccine coverage and adolescent human papillomavirus vaccination ( , ). we have identified characteristics, such as not previously receiving an influenza vaccine, that are readily available in the electronic health record and could easily be used to identify covid- vaccine-hesitant individuals who might especially benefit from the motivational interviewing approach. our findings suggest that a multipronged approach may be needed in which trusted physicians promote vaccine uptake against a backdrop of innovative approaches and channels to combat vaccine misinformation, consistent with the body of literature of strategies to address vaccine hesitancy ( ). a strength of our study is that the large, nationally representative sample allows generalization of our findings. in addition, the timing of the survey administration coincided with a peak time of the pandemic in many parts of the united states, making the findings particularly timely and salient. our study also has limitations. first, we queried individuals about their intent to be vaccinated at a time when a vaccination is not yet available. it is possible that as more details regarding a potential vaccine are known, some participants who indicated their response depended on additional information may change their response. in addition, our study was not designed to determine what additional information is needed, or how best to deliver it. future research is needed to better delineate the types of assurances needed and the messengers most likely to be trusted (for example, community leaders and religious leaders). in conclusion, we found that a substantial proportion ( . %) of participants in a national survey conducted during the coronavirus pandemic would be hesitant to accept vaccination against covid- . black race was one of the strongest independent predictors of not accepting vaccination; this is especially alarming, given the outsized impact of covid- among african-americans. our findings suggest that many of the individuals who responded "not sure" may accept vaccination if given credible information that the vaccine is safe original research attitudes toward a potential sars cov- vaccine among u.s. adults and effective. as vaccine development proceeds at an unprecedented pace, parallel efforts to proactively develop messages to foster vaccine acceptance are needed to achieve control of the covid- pandemic. ) "there is no way i trust big pharma companies." vaccine development or testing processes ( . ) ( . ) "i'm thinking a vaccine now might be approved too quickly because of political pressure." "rushing to get a vaccine out will be a danger." continued on following page world health organization. coronavirus disease (covid- ): situation report . world health organization; . accessed at www.who.int/docs/default-source/coronaviruse/situation-reports / covid- -sitrep- .pdf?sfvrsn= f _ on the socio-economic implications of the coronavirus pandemic (covid- ): a review asian critical care clinical trials group. intensive care management of coronavirus disease (covid- ): challenges and recommendations what worries the world topline & methodology. . accessed at www.ipsos.com /sites/default/files/ipsos-coronavirus-us-aggregate-topline- vaccines through centuries: major cornerstones of global health. front public health herd immunity": a rough guide current status of potential therapeutic candidates for the covid- crisis microneedle array delivered recombinant coronavirus vaccines: immunogenicity and rapid translational development accessed at www.nytimes.com/interactive/ /science/coronavirus-vaccine-tracker national update on measles cases and outbreaks-united states who releases list of threats to global health institute for health metrics and evaluation projected population benefit of increased effectiveness and coverage of influenza vaccination on influenza burden in the united states estimate of the basic reproduction number for covid- : a systematic review and meta-analysis predicting willingness to vaccinate for covid- in the us the prevalence of limited health literacy health literacy and preventive health care use among medicare enrollees in a managed care organization hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease -covid-net, states racial and ethnic disparities in sars-cov- pandemic: analysis of a covid- observational registry for a diverse u.s. metropolitan population. medrxiv. preprint posted online the influence of social norms on flu vaccination among african american and white adults open ended if not sure: what makes you unsure whether you will get the vaccine?open ended what is your best guess as to whether you will get the coronavirus within the next months? i don't think i will get the coronavirus i think i will get a mild case of the coronavirus i think i will get seriously ill from the coronavirus i have already had the coronavirus appendix reference to specific conspiracy theories ( . ) ( . ) "[. . .] i personally do not believe that the virus was fully caused by infected animals in wuhan.[. . .] i believe that the vaccine is a governmental covert method to kill off more people, and then some." "as long as bill gates is involved with any of this, there's no way in hell i or anyone in my family would do this." "because i heard the government was to put a chip in you when you get the vaccination and i do not want a chip inside of me." distrust unspecified ( . ) ( . ) "i don't trust them." key: cord- -oyfx ij authors: thunstrÖm, linda; ashworth, madison; shogren, jason f.; newbold, stephen; finnoff, david title: testing for covid- : willful ignorance or selfless behavior? date: - - journal: nan doi: . /bpp. . sha: doc_id: cord_uid: oyfx ij widespread testing is key to controlling the spread of covid- . but should we worry about self-selection bias in the testing? the recent literature on willful ignorance says we should – people often avoid health information. in the context of covid- , such willful ignorance can bias testing data. furthermore, willful ignorance often arises when selfish wants conflict with social benefits, which might be particularly likely for potential ‘super-spreaders’ – people with many social interactions – given people who test positive are urged to self-isolate for two weeks. we design a survey in which participants (n = ) choose whether to take a costless covid- test. we find that % would take a test. surprisingly, the people most likely to widely spread covid- – the extraverts, others who meet more people in their daily lives and younger people – are the most willing to take a test. people's ability to financially or emotionally sustain self-isolation does not matter to their decision. we conclude that people are selfless in their decision to test for covid- . our results are encouraging – they imply that covod- testing may succeed in targeting those who generate the largest social benefits from self-isolation if infected, which strengthens the case for widespread testing. covid- rapidly developed into a pandemic, and by march , the usa had the highest reported number of infected people in the world. a general message from public health experts is that effective control of the spread of covid- requires widespread medical testing (who, ) . the testing will serve to determine whether people are infected or not, and ideally also if they have been infected and have reached immunity status. three reasons motivate widespread testing. first, if a person learns that they are infected, they can take appropriate measures to reduce the probability of infecting others, such as the recommended -day self-isolation (harvard medical school, ) . second, the data provided by widespread testing will better inform the need for the current social distancing policies (e.g., sheltering at home, avoiding gatherings of or more people, keeping at least feet away from other people and temporarily closing schools, universities, daycare centers, major sports leagues, cultural events and public spaces) (stock, ) . third, testing provides data about the asymptomatic rate in the usa (the share of infected people who show no or very mild symptoms) and insight into how close americans are to developing herd immunity to covid- . this information is useful in order to determine when and where it makes sense to relax these costly social distancing measures. while the usa has increased its capacity to conduct more testing, around . % of the population had been tested by april (covid tracking project, ) . the effectiveness of testing in controlling covid- depends largely on how the tests are conducted. the ideal scenario is to test everyone, but that is infeasible. a second-best scenario is random sample testing (stock, ) . but for random testing to be effective, all sampled people would either need to voluntarily agree to be tested (which is unlikely, as we explain) or be forced to do so (which is illegal in the usa). the third-best (and first-best feasible) strategy is voluntary random testing. this strategy, however, could lead to a systematic selection biaswe will only test those individuals who prefer to learn their health status regarding covid- ; a significant fraction of people might not want to know. these individuals might find that their private costs outweigh any social benefits from not infecting others. this implies that they might want to avoid testing. if their private costs include above-average opportunity costs of social interactions, then individuals who decline to be tested may also be disproportionately likely to become superspreaders. to understand why this might happen, consider the ongoing literature on willful ignorance of health information (also called strategic ignorance). while standard economic theory suggests people never ignore information that enables them to adjust behavior (stigler, ) , many new studies find that people willfully ignore medical diagnoses, even when such knowledge would enable them to adjust behavior to better accommodate their health condition (sharot & sunstein, ) . for example, we see willful ignorance in many people at risk for breast cancer (thompson et al., ) , alzheimer's disease (cutler & hodgson, ) , hiv (hightow et al., ) and huntington's disease (oster et al., ) . the study by ganguly and tasoff ( ) is particularly relevant: they observe people will avoid a costless test for herpesa disease for which there is currently no cure, but for which information is useful in that it helps adjust behavior. people have also been found to willfully ignore health risk information, such as calories in food (thunström et al., ; woolley & risen, ; sunstein, ; thunström, ; nordström et al., ) . willful ignorance of health outcomes is likely to arise when people are torn between what they think they should do and what they want to do (thunström, ; woolley & risen, ) , or when ignorance allows them to form optimal expectations (downplay the probability of a bad health outcome; oster et al., ; nordström et al., ) . for instance, a person may think she should eat healthy, but want to indulge in ice-cream-she might then choose to avoid learning about the exact amount of calories in the ice-cream in order to avoid either her inner pressure to reduce the ice-cream consumption or the guilt from consuming it despite being aware of the calorie content. in this paper, we explore self-selection in covid- testing in the usa. we examine if people willfully avoid getting tested for covid- , and, if so, what individual or household characteristics and circumstances are associated with testing avoidance. given that random voluntary testing is not yet available in the usa, there are no observational data to rely on for our analysis. we therefore design a hypothetical randomized controlled trial (rct). we recruit a nationally representative sample of participants. the study entails two treatments, across which we vary information about the potential emotional cost of testing before asking if participants would agree or disagree to a financially costless covid- test. in the baseline treatment, we inform participants that if they are found to be infected, they are urged to self-isolate at home for days. in the high-cost treatment, we tell participants that those who test positive are strongly urged to self-isolate, which may be in a self-quarantine site away from home. we assume the test itself is costless and that the only cost incurred from a covid- test is the recommended self-isolation for days should the test come back positive. if people are concerned only with their private benefits and costs from taking a covid- test, those with large private benefits and low private costs from knowing that they are infected will be the most likely to get tested. private benefits are significant for people at elevated risk for severe health consequences if they contract the virus or with family members at higher risk, while private costs are low for those who generally live a solitary life, professionally and in private. we expect elderly and those who haveor have a family member that haspre-existing conditions to be more willing to test. furthermore, we expect those at the lowest risk of losing out financially (e.g., risk to labor income or health care costs) or emotionally from self-isolating (i.e., if they are introverts who attach a low value to social interactions) to be the most willing to get tested for covid- . in contrast, if people are concerned only with social benefits and costs, we would expect those most at risk of exposing others to be the most likely to get tested (e.g., potential 'super-spreaders'; i.e., people with jobs that entail mixing with other people, people living in urban areas, young people and people who are extroverts and attach a high value to social interactions). people with the potential to be super-spreaders might be torn about learning whether they are infected by covid- . both private costs and social benefits from being urged to self-isolate for the next days (harvard medical school, ) might be high for this group, and so influence their testing decision in opposite directions. for example, consider the behavior of an extrovert who values social interactions highly. if unsure of being infected, the extrovert behaves just as if she is not infected (e.g., as found for huntington's disease, by oster et al., ) . self-isolation means this person needs to give up highly valued social interactionsa factor that might deter them from a voluntary test for covid- . at the same time, their self-isolation provides particularly meaningful private and social health benefits from reduction in exposure to, and spread of, the disease. these benefits to learning whether they are infected might encourage them to voluntarily test. it is an open question if the benefits outweigh the costs, causing the extrovert to take a costless covid- test. similarly, imagine a store clerk who risks losing income if self-isolating for days. the potential private loss of income would deter them from testing, while the social benefits from reducing disease spread would encourage taking the test. again, the decision to test becomes an open question. previous studies show that willful ignorance arises when prosocial behavior is privately costly (dana et al., ; conrads & irlenbusch, ; onwezen & van der weele, ; gigerenzer & garcia-retamero, ; grossman & van der weele, ) . in this study, we find that around % of people want to take a costless covid- test. as might be expected, people who worry more about their health are particularly likely to want to take the test. we also find that those most likely to want to take the test are those most likely to spread the virus if unaware of their infection, including young people and extroverts with a preference for socializing. extroverts might also be at the highest risk for being infected, but even when we control for personal risks (amount of social interactions and worry about own health), we find they are more willing to test. the ability to afford to self-isolate for days does not seem to affect the willingness to test. our results suggest that there is a significant amount of selflessness in the decision to test; people appear to be highly concerned about the social benefits from testing for covid- and little concerned about private costs. in addition, we do not find the expected treatment effect of our experimental manipulation of the private cost to testing (i.e., the location of self-isolation (at home or in a facility away from home) does not seem to matter to the testing decision). our expectation was that willful ignorance would be higher if selfisolation might take place away from home, since we assume self-isolation away from home is perceived as more costly. one interpretation of the lack of expected treatment effect is that it lends further support to the idea that private costs play a negligible role in the decision to test for covid- . our results matter because they underscore the value of widespread covid- testing, even if such testing cannot be done randomly. our findings suggest that widely available and costless voluntary testing will target rather than scare off those most likely to be 'super-spreaders'. to test people's willingness to take a financially costless covid- test, we designed a hypothetical field experiment. the experiment is a rct with a between-subjects design, consisting of two treatments. in the first treatment (treatment baseline), participants were told they would be urged to selfisolate at home, if having tested positive. in the second treatment (treatment high cost), they were told they might be urged to self-isolate at a special site away from home. participants (n = ) were recruited by the research firm qualtrics, and the sample was required to be nationally representative along the dimensions of gender, age, education, race, income and residential region (east, west, north or south). while the recruitment costs from qualtrics are higher than when recruiting from amazon mechanical turk or turk prime, qualtrics continuously quality checks participants, which enabled us to avoid many issues that may otherwise contaminate online panels (e.g., see chandler & paolacci, ; sharpe wessling et al., ) . participants received standard qualtrics compensation to participate in a survey. testing for the sequence of the experimental study was as follows: step : all participants were asked screening questions at the front end of the survey about their gender, age, education, race, income and region in order to ensure the sample met us national quotas for those characteristics. step : participants were asked whether they had already been tested for the covid- . if 'yes', they were asked why they got tested, the outcome of the test, how many days prior to survey participation they had taken the test and if the test was costly. if 'no', they were randomized into one of the two treatments and asked about their willingness to take a test. specifically, if in treatment baseline, they received the following information: currently, us authorities are working to test more people for the coronavirus. legislators are urging people who test positive, i.e., are found to be infected by the virus, to self-isolate at home for days. if in treatment high cost, they were instead told: currently, us authorities are working to test more people for the coronavirus. legislators are urging people who test positive, i.e., are found to be infected by the virus, to self-isolate for days. some states have started building self-quarantine sitessites where people who have the virus would be isolated for days. if people stay at those sites, it is easier to ensure they comply with the guidelines to self-isolate. thereafter, participants in both treatments were asked: if you were given the opportunity to take a coronavirus test for free within the next days, would you take the test? default alternatives to get or not get information have been shown to affect observed choices of ignorance (grossman, ) . to avoid nudging participants toward any particular answer, there was no default alternative; participants needed to choose either "yes, i would take the test," or "no, i would not take the test." step : all participants were asked about their current level of social distancing (how many people outside their household they had been within feet of in the last days; how many gatherings with more than people they had participated in; and self-assessed level of compliance with social distancing). they were also asked whether they supported the public recommendations for social distancing in general. step : participants were asked questions about factors that might affect the perceived cost of a positive covid- test (implying social isolation for days), as well as the perceived benefits from being able to make behavioral adjustments. they were asked about their job situation, job security and possibility of the main income provider in the household taking sick leave; risk factors for contracting the virus (e.g., living in a urban area, working in a health care facility, working in a grocery store or pharmacy); risk factors (for self or any children) for suffering severe health consequences if contracting the virus (e.g., underlying health conditions that increases the risk, such as cancer, obesity, diabetes, etc.); level of extraversion (francis et al., ) ; and social lifestyle. step : participants were asked about religious belonging, religiosity, political affiliation and social and fiscal conservatism (everett, ) . the full survey can be found in the online supplementary material. of our total sample, participants stated that they had already been tested, while stated that they had not already been tested. we asked those who had been tested for the primary reason they had taken the covid- test. table shows their answers. as expected, given the current prevailing strategy in the usa of focusing the limited testing on people who are symptomatic, most people got tested because they themselves showed symptoms (almost %) or because someone close to them either showed symptoms or was diagnosed with covid- (around %). summary statistics for the participants who had been tested before participating in our study are shown in the online supplementary material. our analysis focuses on the participants who stated that they had not been tested for covid- . due to a coding error in the survey at the beginning of the data collection, seven participants did not respond to the question on whether they were a business owner, employed or unemployed. we dropped these seven participants from our analysis, and we were left with observations. table presents the summary statistics for these participants. unless otherwise stated, all of the remaining analysis focuses on the results for this group of participants. table shows that % of participants who had not yet been tested for covid- are female. the variable age describes a participant's age in years, and the mean age in our sample is years. the variable high-risk age is a dummy variable that takes the value if a person is aged years or older. table shows that % of our participants are aged years or older. the variable rural area takes a value if participants stated that they live in a rural area and if they live in an urban area. table shows that % of our participants live in a rural area. the variables emotional tolerance and financial tolerance are dummy variables that take the value if the participant answered that the maximum time (from the time of taking the survey) he/she would be able to emotionally or financially sustain social distancing was days or longer, given the -day recommended time to self-isolate if you test positive for covid- . these variables take the value if their stated maximum time was days or less. table shows that % of participants stated that they can afford to continue their testing for covid- current level of social distancing for days or more, while % stated that they can emotionally tolerate another days or more of their current level of social distancing. the variable lifestyle impacthealthy is an index that measures the extent to which social distancing has changed participants' behavior in a healthier direction. participants were assigned a value for each of the following: if they stated that social distancing had (a) increased consumption of vegetables, (b) decreased in-between-meals snacking (excluding fruits and vegetables), (c) increased time spent in green spaces, (d) increased time spent doing strenuous or (e) moderate exercising and (f) reduced stress. this variable could take a value between and , where higher values represent healthier changes. the variable lifestyle impactunhealthy is an index that measures the extent to which social distancing has changed behavior in an unhealthy direction. participants were assigned a value for each of the following: if they stated that social distancing had (a) decreased consumption of vegetables, (b) increased in-between-meals snacking (excluding fruits and vegetables), (c) decreased time spent in green spaces, (d) decreased time spent doing strenuous or (e) moderate exercising and (f) increased stress. this variable could also take a value between and , where higher values represent a higher number of unhealthy changes. the summary statistics in table suggest that social distancing has led to more unhealthy behavior than it has healthy behavior, as implied by the lower mean value of lifestyle impacthealthy. we note, however, that these variables are crude measures of the lifestyle impact from social distancing, where each change is given equal weight, although some changes might have a more important health effect than others. the variable business impact takes a value if a participant is a business owner whose business has experienced negative impacts due to covid- , such as their operation losing income, going out of business or being at risk of going out of business. the variable employer impact takes a value if a participant is an employee and his/her employer has experienced a negative impact due to covid- , such as their employer losing income or being at risk for going out of business, if they had experienced pay cuts, reduced working hours or were on unpaid leave as a result of the virus. table shows that of participants who are business owners, or where until a month ago (n = ), % had experienced a negative impact on their business from covid- . of participants who are employees, or were until a month ago (n = ), % had experienced a negative impact on their job security, payment or employer revenues. the variable social distant compliant - feet measures how many people a participant has been close to in the last days. participants could state 'none', person, - people, - people, - people, - people, - people, - people or 'more than people'. we assigned participants the midpoint of the range they picked. for those in the highest range ( and more), we assumed the same size interval as the second to highest interval (i.e., we assumed an endpoint of the last interval equal to people). table shows that the average number of people that participants had been close to during the last days, besides their household members, was . . although not reported in the table , the median was . . the variable social distant compliantgroups measures how many times during the last days a participant has been in a room with or more people. participants could state a value anywhere between zero and ' or more times'. the median of this variable is . table shows that participants on average had been in a room with or more people around . times during the last days. the variable self health risk measures the sum of underlying health conditions that would put the participant at higher risk for developing severe health consequences if becoming infected with covid- . these health conditions include chronic respiratory conditions, heart disease, neurological conditions, diabetes and obesity (cdc, ). the variable child health risk measures the same sum of underlying health conditions for a child in the household. the variable worry about own health is based on the stated extent to which participants worry about their own health due to covid- , where the value indicates 'not at all' and the value indicates 'a lot'. the dummy variable insurance takes a value if a participant states that he/she has private health insurance or is covered by medicare or medicaid and if the participant stated not having any coverage. table shows that % of participants have insurance or medicare or medicaid coverage. the dummy variables republican, democrat and other political party take a value if a participant identifies as republican, democrat or neither, and otherwise. about % of participants identify as republican, % as democrat and % as other. that they had been placed on unpaid leave; and % of workers said that they had had their pay reduced. the variable extrovert is based on the extraversion scale developed by francis et al. ( ) and includes participants' answers to questions such as "are you a talkative person?" and "can you easily get some life into a rather dull party?" in addition to the extraversion scale, we also asked participants to indicate their level of agreement with statements about their general social lifestyle, such as "my social life is very important to me," and "in my spare time, my favorite thing to do is to spend time with friends." if the participant answered yes to three or more of these questions, they were assigned a for the extrovert dummy variable. the answers to these statements were, however, highly correlated with the extraversion scale, so they were excluded from our analysis because they provided little or no additional information. when we pool participants from both treatments who had not been tested prior to participating in our study (n = ), we find that % of participants would be willing to take a costless covid- test. we find no difference in shares of participants willing to test across treatments (pearson χ ( . ); p = . ), suggesting that the location of self-isolation (at home or in a facility away from home), in the event the test comes back positive, is not an important determinant of people's willingness to test for covid- . not only is the treatment effect small, it is also of the unexpected signthe share of people willing to test if self-isolation would happen at home is smaller ( %) than the share of people willing to test if self-isolation might happen at a facility away from home ( %). if anything, people might be slightly more inclined to test if a positive result could lead to isolation away from home (potentially due to this also signaling the greater severity of the covid- situation), but the size of the effect is too small for us to detect with our sample size. we have ruled out participants who stated that they would prefer not to take the test ( / ) were asked for their reasons not to want to take the test. they were given the following alternatives and were asked to mark all that apply: "i would not change my behavior if i learned i had the virus" ( %); "i do not want to self-isolate for days" ( %); "my job prevents me from self-isolating for days" ( %); "i think i have already had the virus" ( %); "it would cause me emotional discomfort if i knew i had the virus" ( %); "it doesn't matter to me if i get tested or not" ( %); other ( %). the numbers in parentheses show the shares of participants who agreed with the statement. as shown, a large share of participants stated that the test would not matter, and that they would not change their behavior anyway. a potential reason for the prominence of these reasons could be that they are already highly complying with social distancing. (table shows that the more people comply with social distancing, the less likely they are to want to take a covid- test.) however, a large share also states 'other', suggesting that the alternatives presented to our participants did not cover the full range of reasons as to why people may refrain from testing. we encourage future research to further explore these reasons. that this absence of identifiable average effect masks any potentially 'rational' heterogeneity in the population (i.e., we have explored whether there exists a treatment effect for subgroups of the population, such as those with children, higher-quality homes (as measured by income) or health anxiety (as measured by underlying health conditions)). one interpretation of the absence of treatment effect is that people assign little weight to the personal cost associated with the location of self-isolating when they decide on whether to take a covid- test. we pool participants from both treatments and examine the determinants of willingness to test. we estimate a probit model. table shows the resulting average marginal effects. concerns about own health are captured by the variable worry about own health. the results in table imply that the more a person worries about their health due to covid- , the more likely they are to take a test. the inclusion of this variable in our model also renders the coefficient for the variable that measures underlying health conditions (i.e., self health risk) small and statistically insignificant (if worry about own health is excluded from the regression, self health risk has the expected positive, and statistically significant, effect on willingness to test). we do not find that people with children who have underlying health conditions are more likely to take the test, perhaps due to the expectation that people of young age are less affected. this result remains robust if we recode the variable child health risk into a dummy variable that takes the value if any child in the household has one or more underlying health conditions. variables that affect a person's financial situation do not seem to matter to the willingness to take a covid- test. in particular, we do not find an effect from business impact or employer impact. we examine the robustness of these findings to alternative measures of business and employer impact. first, we instead include the multitude of variables underlying business impact and employer impact in the regression model (see footnote ), but we do not find an effect from any of those variables that is close to statistically significant at even the % level. furthermore, we do not find an effect on willingness to test from financial tolerance. second, we recode the variables such that they range from little impact to severe impact (ranging from if a business owner or employee has experienced no adverse effects from covid- , to one or multiple effects). again, we find no statistically significant effects from these variables on the willingness to test. taken together, these results suggest that people do not consider their own private costs from a positive test when deciding on taking a covid- test. similarly, we find no effect on the willingness to test from emotional tolerance, implying that the private emotional cost from social isolation in the event of a positive test might not affect the decision to take a covid- test. we find that healthy younger people are more likely to take a test than healthy older people, as implied by the negative parameter estimate for high-risk age. this age effect is consistent with findings in other studies that standard errors in parentheses. *p < . , **p < . , ***p < . . observe older people avoid health-related information more than younger people (thunström et al., ; gigerenzer & garcia-retamero, ) . while this result could imply that older people are more likely to be willfully ignorant, it is also in line with the idea that those with more social interactions (younger people) are more likely to get tested. studies find that people below years old have more social contacts, and therefore are more likely to transmit infectious diseases (mossong et al., ) . furthermore, we find that those who have met more people during the last days are more willing to take the test, as suggested by the negative parameter estimate for social distance compliant - feet. furthermore, the potential 'super-spreaders'the extrovertsare more likely (by %) to take a test compared to the introverts. taken together, this suggests that social benefits weight heavily in people's decisions to test; those most at risk to spread covid- are the most willing to get tested. we find that republicans are % less likely than democrats to get tested. we speculate that this might be due to different information sources and because the risks of covid- might be portrayed differently in liberal and conservative popular and social media. we examined the robustness of this result by including a conservatism scale (everett, ) in the probit regression, and the result remains the same: people who are more conservative are less likely to want to take a covid- test. the conservatism scale is, however, not included in the final model, given its high correlation with the political dummy variables. finally, we find that people with health insurance, or coverage from medicare or medicaid, are around % more likely to take the test. this result might suggest that people who lack health care coverage use willful ignorance as a means to reduce anxiety about how to deal with a diagnosis. this would be in line with previous studies that suggest willful ignorance of health diagnoses may be motivated by the drive to reduce anxiety about the future (e.g., oster et al., ) . our results are robust to the inclusion of other explanatory variables, such as race, education, income and profession with high exposure to infected people (health care worker, store clerk, etc.). but these variables lack explanatory power or are highly correlated with other explanatory variables included in table . the tests conducted prior to participating in our study were neither randomly offered to people (so far, testing for covid- in the usa has been primarily of individuals who showed symptoms), nor costless ( % of those who had tested prior to participating in our study stated the tests were financially costly and % said testing was time consuming). the value of data on observed testing is limited when it comes to helping us understand whether people might purposefully ignore such tests. while acknowledging that, we still compare our identified determinants of testing in table to the determinants of having taken a test before participating in our study (see online supplementary material). while the levels of statistical significance vary, all coefficients are of the same sign as those in table , except for four variables. having taken a test before participating in our study seems to be positively affected by having spent more time in groups with or more people (i.e., social distance compliantgroups), as well as by a child having underlying health conditions (i.e., child health risk). employer impact has a (weakly) statistically significant positive effect on testing prior to participating in our study, while it is not statistically significant in table . insurance is not a statistically significant determinant of having been tested prior to participating in our study, while it does have an effect in table . widespread testing is one of the most important actions that us governments at any level can undertake to help slow down the spread of covid- . given budget and testing supply constraints, it is likely that random, but voluntary, testing will be the most effective policy. we design a survey to examine the risks from self-selection into taking a covid- test. overall, we observe that around % of people would agree to a costless covid- test. we find that people who are more worried about their own health due to covid- are more likely to test, as are young healthy people, relative to older healthy people. ability to afford self-isolation for days does not seem to affect the decision to test. furthermore, people who worry more about their health, and people with health insurance or health coverage through medicare or medicaid, are more likely to take the test, as are people identifying as democrats compared to republicans. contrary to our expectation, we also find that potential 'super-spreaders' are more likely than other individuals to agree to a costless covid- . it could be that extroverts are more willing than expected to take a covid- test because their private cost of doing so is unusually low due to the broadly implemented social distancing at the time of data collection for this study. if extroverts are already relatively isolated (i.e., due to a stay-athome order and mandated closures by the state governor of public spaces, such as gyms, restaurants and bars), the personal cost of testing might be low. furthermore, extroverts might be more likely to get infected if they socialize more, which could be a 'selfish' motivation to get tested. however, we control for the current level of compliance with social distancing, which should address both of these private motivations for increased probability of testing, and we find that people who comply more are less motivated to take the test. we also control for their worry about own health due to covid- . even so, the positive effect on willingness to test from being an extrovert persists. we therefore conclude that the positive effect of being an extrovert on willingness to test for covid- is likely due to social health benefits weighing more heavily in their decision than their private costs from potential self-isolation for days, should the test come back positive. the importance of the prosocial motive in determining covid- testing is consistent with the results of the study by jordan et al. ( ) , who find that prosocial messages are more effective than self-interested messages in promoting behavior that prevent the spread of covid- (e.g., hand washing, hand shaking, hugging). our results suggest that the risks of adverse selection (in terms of failing to target the people most likely to spread the virus) in testing for covid- might be fairly low. this underscores the value of widespread testing, even if it cannot be truly random, and the importance of making such testing available nationwide in the usa as soon as possible. an important shortcoming of our analysis is that it builds on hypothetical survey data. it is well documented that survey answers may be affected by a 'hypothetical bias', meaning that people answer one way in a survey and behave in a different way when faced with real, incentivized decisions. this risk pertains to our study as well, and the hypothetical bias might be particularly pronounced if the choice to test for covid- is regarded as prosocial. several studies suggest that a hypothetical bias is particularly likely when measuring prosocial behaviorpeople often exaggerate the extent to which they engage in such behavior (e.g., murphy et al., ; vossler et al., ; jacquemet et al., ) . furthermore, it is possible that personal costs to the testing decision are less salient in a hypothetical context. once testing is more widespread in the usa, it will be important to examine who actually chooses to get tested, and the extent to which they deviate from the general population. that said, hypothetical and incentivized behavior generally correlate, such that an analysis like ours can provide important insights into the potential pitfalls of voluntary testing, prior to the actual testing. this is useful information to have on hand when designing an efficient and costeffective testing strategy. to view supplementary material for this article, please visit https://doi.org/ . /bpp. . l i n d a t h u n s t r Ö m e t a l . what you can do if you are at higher risk of severe illness from covid- lie for a dime: when most prescreening responses are honest but most study participants are impostors strategic ignorance in ultimatum bargaining most recent data to test or not to test: interest in genetic testing for alzheimer's disease among middle-aged adults exploiting moral wiggle room: experiments demonstrating an illusory preference for fairness the item social and economic conservatism scale (secs)', plos one the development of an abbreviated form of the revised eysenck personality questionnaire (epqr-a): its use among students in england, canada, the usa and australia fantasy and dread: the demand for information and the consumption utility of the future cassandra's regret: the psychology of not wanting to know strategic ignorance and the robustness of social preferences self-image and willful ignorance in social decisions coronavirus resource center failure to return for hiv posttest counseling in an std clinic population preference elicitation under oath don't get it or don't spread it? comparing self-interested versus prosocially framed covid- prevention messaging social contacts and mixing patterns relevant to the spread of infectious diseases a meta-analysis of hypothetical bias in stated preference valuation strategic ignorance of health risk: its causes and policy consequences when indifference is ambivalence: strategic ignorance about meat consumption optimal expectations and limited medical testing: evidence from huntington disease how people decide what they want to know mturk character misrepresentation: assessment and solutions the economics of information random testing is urgently needed ruining popcorn? the welfare effects of information psychosocial predictors of brca counseling and testing decisions among urban african-american women strategic selfignorance welfare effects of nudges: the emotional tax of calorie menu labeling truth in consequentiality: theory and field evidence on discrete choice experiments closing your eyes to follow your heart: avoiding information to protect a strong intuitive preference report of the who-china joint mission on coronavirus disease we thank the stroock fund for financial support. this study was approved by the irb at university of wyoming and was pre-registered in the aea rct registry (rct id: aearctr- ). key: cord- -iswbgqqe authors: jonker, leonie t.; lahr, maarten m.h.; festen, suzanne; oonk, maaike h.m.; de bock, geertruida h.; van leeuwen, barbara l. title: perioperative telemonitoring of older adults with cancer: can we connect them all? date: - - journal: j geriatr oncol doi: . /j.jgo. . . sha: doc_id: cord_uid: iswbgqqe objectives: although the increasing cancer incidence in older patients is widely recognised, older patients remain underrepresented in clinical cancer trials and ehealth studies. the aim of this research is to identify technological and patient-related barriers to inclusion of this population in a clinical ehealth study. material and methods: this is a retrospective analysis of a prospective cohort study with older patients (≥ years) undergoing cancer-related surgery, who were identified for a perioperative telemonitoring study. reasons for ineligibility and refusal had been prospectively registered. characteristics and postoperative outcomes were compared between participants and non-participants. results: between may and march , patients were assessed for eligibility, resulting in participants and non-participants. the main reason for ineligibility was lack of internet access at home (n = ), while main reasons for refusal were perceived high mental burden (n = ) and insufficient digital skills (n = ). compared with participants, non-participants were significantly older (mean age vs. , p = . ); more often female ( % vs. %, p = . ), unmarried ( % vs. %, p = . ) living alone ( % vs. %, p = . ); had a higher asa classification ( % vs. %, p = . ); often had polypharmacy ( % vs. %, p = . ); and were more often discharged to skilled nursing facilities ( % vs. %, p = . ). conclusion: our results confirm the underrepresentation of older female patients with little support from a partner and higher comorbidity. we should be aware of technological and patient-related barriers to including older adults with cancer, in order to avoid further dividing patients with low and high digital health literacy. older patients (over the age of ) represent the majority of global cancer cases, with a predicted absolute number of million worldwide by [ ] . surgery is a fundamental part of treatment in more than % of cancer cases, as well as for older patients [ ] . higher age alone does not necessarily increase the risk of adverse postoperative events, but the prevalence of age-associated comorbidities and frailty (age-related cumulative decline in multiple physiological systems) does increase this risk [ ] . frail older patients are three to four times more likely to develop postoperative complications compared with non-frail older patients [ , ] . moreover, the occurrence of complications has a considerable impact on the quality of life and the survival of older patients [ ] . together with the fact that hospital admissions have been shortened due to changes in modern health care [ ] , this highlights the necessity of prevention and early detection of postoperative complications in this population. new digital technologies (i.e., ehealth) are emerging rapidly in health care to promote patients' self-management and engagement and improve patient-centred cancer care [ ] . the interest in remote care delivery by ehealth has increased even more during the current covid- pandemic, as remote consultation decreases the risk of spreading the virus and could decrease the pressure on health care resources [ , ] . additionally, ehealth is used to remotely monitor patients' postoperative recovery in surgical wards or at home after hospital discharge [ , ] . this so-called telemonitoring could contribute to timely detection of postoperative complications and therefore potentially decrease the impact of these complications in frail older patients with cancer [ ] . although the increasing incidence of cancer in older patients is widely recognised, these patients remain underrepresented in clinical cancer trials [ , ] . they are excluded from clinical cancer trials because of study restrictions, comorbidity, polypharmacy, or physicians' attitudes [ ] . older patients are also underrepresented in most perioperative ehealth intervention studies. this underrepresentation of older, and often frail, patients leads to a bias in research outcomes, non-generalisable results and inequality in healthcare provided [ ] . this poses a real risk that ehealth interventions will remain geared towards a younger, more flexible population, and will result in the exclusion of the population likely to show the greatest benefit. also, ehealth literacy is known to be lower among older adults with cancer compared with their younger counterparts [ ] . the covid- pandemic has further increased the need for new digital solutions in health care and clinical research [ , ] . it is thus of the utmost importance to identify barriers to participation in clinical ehealth trials among the older population. when these barriers are known, both clinical ehealth trials and ehealth applications may be adjusted so that they may benefit the entire oncological population, including frail older patients. in a prospective cohort study with the aim of assessing feasibility of perioperative telemonitoring of older patients with cancer, we were able to include approximately half of the identified patients. to investigate possible technological and patient-related barriers to participation, we analysed reasons for ineligibility and refusal and differences in characteristics of non-participants and participants. to explore the impact of possible benefits a postoperative telemonitoring intervention could provide for our population, we additionally compared the postoperative outcomes between non-participants and participants. this study is a retrospective analysis of a prospective cohort study with older patients undergoing cancer-related surgery, who were identified for a perioperative telemonitoring study (netherlands trial registration number: nl ) [ ] . the prospective telemonitoring study was conducted in a tertiary referral hospital in the north of the netherlands and approved by the local medical ethical committee (registration number: / ). in consultation with legal officers at our local medical ethical committee we obtained permission to collect additional routine data on care of all identified patients. the principal reason was to collect reasons why candidates did not participate, to identify potential modifiable factors to improve on this situation for future studies. also, it was evaluated that obtaining additional consent was perceived too burdensome for patients and/or carers. we had identified patients over the age of with an indication for oncological resection of a solid malignant tumour. patients had been approached at the hospital's outpatient clinic or by telephone in the period between may and march , after they were identified for the study by a surgical nurse or surgeon from the treatment team. patients were eligible if they had internet access at home. exclusion criteria were severe auditory, visual and cognitive impairment that were expected to impair the ability to use digital technologies or hear/understand the explanation by telephone; being wheelchair-or bed-ridden; having contact dermatitis; insufficient understanding of dutch; and emergency surgery. participants had been assessed at three moments in time: before surgery, before hospital discharge and at three months after surgery. participants had used a mobile application connected to various electronic monitoring devices. physical activity had been measured using an accelerometer-based wearable activity monitor (fitbit charge , fitbit inc., san francisco, ca, usa) during the entire study period. for two weeks after hospital discharge, postoperative recovery had been monitored using the mobile application and additional devices to measure temperature, blood pressure, heart rate, pain, and the occurrence of other postoperative symptoms. due to the observational character of the study, no intervention followed when a deviation had been detected in monitored data. patients had only been contacted by telephone by the research physician if no data was transferred or if alarming parameters had been observed. following the latter, the treating physician would have been contacted if there was a need for medical consultation. we had implemented several strategies in our study design to minimise refusal, based on solutions presented in previous studies for approaching older patients [ ] . first, we recognised the importance of adequate communication, especially with older patients. we preferred face-to-face contact to inform patients, offered clearly written study information and emphasized that the study case manager in charge was easily available by telephone for any questions during the study period. second, we involved patients' family members in the recruitment process, as family members have a major influence on the decision to participate. the study information at the outpatient clinic was preferably provided with a family member present. the supporting role of the family member was emphasized before the start of the study, and if the patient preferred that communication about study participation or technological explanation was given to a family member, this family member was approached by telephone. third, we decided to plan follow-up visits with patients at home or schedule appointments to coincide with planned hospital visits because additional hospital visits discourage patients from participating [ ] . these strategies to minimise refusal were also meant to promote study completion. family members were involved in technical actions. technology support was provided by the case manager throughout the whole study period by telephone and if necessary, at home or coinciding with planned hospital visits [ ] . reasons for ineligibility and refusal had been prospectively registered in a database by the case manager directly after assessing eligibility or after approaching patients for the prospective telemonitoring study. relevant demographics, preoperative indicators of frailty, surgical data and postoperative complications of participants were prospectively collected in face-to-face assessments and from hospital medical records. routine care data about non-participants was retrospectively collected from hospital medical records to evaluate health outcomes. no additional non-consented patient data was collected outside routine care. collected data on the somatic domain of frailty included preoperative physical status assessed by an anaesthesiologist (american society of anesthesiologists [ ] [asa classification]), comorbidity (charlson comorbidity index [ ] ) and, polypharmacy (> different types of medication [ ] ). nutritional status was assessed using body mass index (bmi). marital status and housing data were collected to indicate social status. data on the psychological domain was collected from the routine consultation with a nurse at admission and registered in the medical records; including i) concerns about hospital admission, ii) anxiety that influenced daily life and, iii) the use of any psychiatric medication. functional status had been determined using the reported katz activities of daily living (adl [ ] ) score. data on tumour location, recurrence of disease, primary malignancy, neoadjuvant therapy, and anaesthesia time was collected. postoperative outcome measures found in the medical records of the individual treatment centre, were collected from its administration. postoperative outcome measures included postoperative icu (intensive care unit) admission, length of hospital stay, complications related to surgery in-hospital and within days after discharge (clavien-dindo classification ≥ [ ] ), unplanned hospital readmission to the individual treatment centre and outside the treatment centre within days after discharge, referral to a nursing home or skilled nursing facility (snf) post-discharge, and overall survival at three and twelve months. we compared characteristics and outcomes from non-participants and participants using an independent sample t-test for parametric continuous data, mann-whitney u test for non-parametric continuous data, and pearson's chi-squared or fisher's exact test for categorical data. a pvalue < . was considered statistically significant. data on baseline characteristics was only used for analysis if it was available for more than % of both groups. we compared postoperative outcomes for all patients and per subgroup, classified by type of primary malignancy (gastro-intestinal, gynaecological, or other oncology). the participants and non-participants who underwent surgery were included in overall survival analyses using the kaplan-meier with log-rank testing. data was analysed with ibm spss statistics version (ibm corporation, armonk, ny). out of patients who were assessed for eligibility, patients consented to participate, and patients did not participate (fig. ) . of the non-participants, patients were not eligible for participation and patients did not want to participate. technological barriers to participation were lack of internet access at home (n = ) and the perceived inability to work with electronic devices and mobile applications (digital illiteracy, n = ). the main patient-related barrier was a perceived high mental burden (n = ). baseline characteristics of participants and non-participants are presented in table . compared with participants, non-participants were significantly older and more often female (table ). in addition, non-participants had a significantly higher asa classification, more polypharmacy and less social support based on data regarding marital status and housing circumstances. nonparticipants were more often adl-dependent compared with participants, although this difference was not statistically significant. from the patients who consented to participate, seven patients were excluded before surgery and patients completed the study. reasons for study drop-out were cancellation of surgery, logistic issues regarding baseline assessment, or the combination of a high burden of disease and treatment and performing measurements at home. results of our feasibility study demonstrated that the compliance of performing vital sign measurements and completing electronic health questionnaires was lower than synchronising physical activity (fitbit-)data, suggesting that these aspects were challenging for the patients [ ] . surgery was cancelled for four participants and six non-participants, resulting in analysis of postoperative outcomes of participants and non-participants ( fig. ; table ). compared with participants, non-participants had similar complication rates. difference in readmission rates were not statistically significant ( % vs. %, p = . ). in sub-analysis, these differences in postoperative adverse event rates tended to be larger in the patients who underwent gastro-intestinal oncological surgery, although the difference remained not statistically significant. non-participants were significantly more often discharged to an snf compared with participants. the twelve patients who were discharged to an snf were significantly older (mean age . versus . years old [p = . ]), had a higher asa classification (asa - % versus % [p = . ]), used more medication (% polypharmacy % versus % [p = . ]) and were more often living alone or in a nursing home before surgery ( % versus %, % versus % [p = . ]). the survival analysis in fig. demonstrates no difference in survival between three and twelve months for non-participants compared with participants (p = . ). in this prospective cohort study, we investigated technological and patient-related barriers to participation of older patients with cancerrelated surgery in a perioperative telemonitoring study. main inclusion barriers were ineligibility due to lack of internet access at home, refusal due to digital illiteracy (the perceived inability to work with electronic devices and mobile applications), and a perceived high mental burden. non-participants were older, were more often female, had a higher asa classification, used more medication, and were more often living alone compared with participants. about one fifth of participants and non-participants experienced a serious complication after hospital discharge. in addition, we observed significantly more snf referrals for non-participants compared with participants. no statistical differences were observed in other postoperative outcomes between participants and non-participants. in our study, % of all patients who were assessed for eligibility could not participate because they had no internet access at home. this corresponds with statistics provided by the dutch central bureau of statistics [ ] . although access to the internet in the netherlands has improved considerably in the past decade, in % of the dutch population aged - and % of people aged over still had no internet access at home [ ] . another % of all patients who were assessed for eligibility refused because they thought they possessed insufficient digital skills or felt uncomfortable with acquiring these skills for study purposes. studies have confirmed that the main reason people refuse to learn new technologies is anxiety about using them [ ] . in addition, ageing causes a decrease in self-efficacy, memory and speed of learning [ ] . however, if the perceived advantages of new digital technologies are large and relevant enough and family or peer support is present, older adults are able to overcome their fears and start learning to use new technology [ , ] . one of the main reasons for refusal was a perceived high mental burden, which might be related to technological barriers as well. an inclusion rate of % ( / ) was achieved through several strategies in our study design such as face-to-face contact, involving family members in the recruitment process and, flexible home study visits [ ] . the difference in characteristics of participants and non-participants in our study corresponds with previous studies [ , , , ] . previous ehealth studies have also demonstrated that older, unmarried, less educated, and lower-income patients use health applications for self-management less frequently than their younger counterparts [ ] . unfortunately, we did not have sufficient data on education level and social-economic status in-hospital complications, a n (%) ( in our population. however, data on social status, housing, and referral to snfs suggests that non-participants had less social support. also, the two patients who were residing in a snf both refused participation. we believe that improving social support would decrease both technological barriers and refusal rates due to a perceived high mental burden. the acceptance and implementation of new digital technologies has been accelerated by the covid- pandemic, as remote consultation and monitoring decrease the risk of spreading the virus [ ] . these changes will lead to a more prominent and perhaps permanent role for telemedicine in future health care and underline the urgency of improving digital technology skills in specific populations such as older adults [ ] . because learning new digital skills takes time and energy [ ] , it is best to empower older adults to do so when they are relatively healthy and not when they have just been diagnosed with cancer or scheduled for surgery. furthermore, it is essential that people who have insufficient social support can rely on professional or peer support provided by, for example, older adult advocacy groups or the government [ ] . a limitation of this study is that we did not have information on the patients' socio-economic status, educational level, geriatric assessment, or impact of complications on functional recovery and quality of life. this is inherent to the retrospective analysis of a prospective cohort study. approximately one fifth of all patients experienced a serious complication within days after hospital discharge, and hospital readmission rates were % for participants and % for non-participants. because we retrospectively collected data regarding non-participants from hospital medical records, complications and readmissions outside our hospital might have been missed; on the other hand, for participants, data on complications and readmissions were complemented with self-reported data at three months follow-up. in addition, participation in the telemonitoring study might have led to identification of more complications. nonetheless, these results demonstrate a high incidence of postoperative complications post-discharge for all patients. more referrals to snfs among non-participants also suggest that complications have a larger impact on this group. additional parameters to measure the impact of complications, such as functional recovery, quality of life and long-term survival, are needed in future research. subsequent telemonitoring studies with older adults should consider various logistical problems in usability and acceptability [ ] . when considering the technological and mental barriers described in this study, studies could be even more inclusive. for example, wifi hotspots could be provided at home for the patients without internet access at home. a technical 'buddy' could be assigned or technological support materials developed to decrease the fear of new technologies and enrol patients with digital illiteracy. the main barriers to older adults' participation in a perioperative telemonitoring study were lack of internet access at home, digital illiteracy, and a perceived high mental burden. non-participants were older and more often female, had a higher asa classification and more polypharmacy, and more often lived alone without a partner compared with participants. the complication rate was high in both participants and non-participants, with a seemingly greater impact of those complications in non-participants. this demonstrates the need for inclusion of underrepresented patients, who are at a high risk for severe postoperative complications and who experience a large impact of these complications. we should be aware of the barriers to participation of this population in order to avoid further dividing patients with low and high digital health literacy. solutions to improve this situation are needed on a societal level and include improving internet accessibility, teaching digital skills and expanding social support for older people. the prospective telemonitoring study was funded by european union's horizon research & innovation program (project grant agreement number , connecare). the funding source had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; nor in the decision to submit the paper for publication. ltj: no conflicts of interest to declare; mmh: no conflicts of interest to declare; sf: no conflicts of interest to declare; mhmo: no conflicts of interest to declare; ghdb: no conflicts of interest to declare; blvl: no conflicts of interest to declare. global cancer incidence in older adults, and : a population-based study global cancer surgery: delivering safe, affordable, and timely cancer surgery frailty and post-operative outcomes in older surgical patients: a systematic review assessment for frailty is useful for predicting morbidity in elderly patients 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elderly people studies of illness in the aged the index of adl: a standardized measure of biological and psychosocial function the clavien-dindo classification of surgical complications: five-year experience internet acces at home in the netherlands technology fear stops older adults from logging on: but scientists are breaking the computer block older adults talk technology: technology usage and attitudes social support and "playing around": an examination of how older adults acquire digital literacy with tablet computers acceptance and use of ehealth/mhealth applications for self-management among cancer survivors attitudes towards and limitations to ict use in assisted and independent living communities: findings from a specially-designed technological intervention we wish to express our gratitude to all colleagues in the connecare consortium for providing input during the development and supporting of the it systems and connected devices used in the prospective telemonitoring study. key: cord- -dka tqx authors: vincalek, jakub; walton, sean; evans, ben title: it's the journey not the destination: building genetic algorithms practitioners can trust date: - - journal: nan doi: nan sha: doc_id: cord_uid: dka tqx genetic algorithms have been developed for decades by researchers in academia and perform well in engineering applications, yet their uptake in industry remains limited. in order to understand why this is the case, the opinions of users of engineering design tools were gathered. the results from a survey showing the attitudes of engineers and students with design experience with respect to optimisation algorithms are presented. a survey was designed to answer two research questions: to what extent is there a pre-existing sentiment (negative or positive) among students, engineers, and managers towards genetic algorithm-based design? and what are the requirements of practitioners with regards to design optimisation and the design optimisation process? a total of participants (n = ) took part in the -part mixed methods survey. thematic analysis was conducted on the open-ended questions. a common thread throughout participants responses is that there is a question of trust towards genetic algorithms within industry. perhaps surprising is that the key to gaining this trust is not producing good results, but creating algorithms which explain the process they take in reaching a result. participants have expressed a desire to continue to remain in the design loop. this is at odds with the motivation of a portion of the genetic algorithms community of removing humans from the loop. it is clear we need to take a different approach to increase industrial uptake. based on this, the following recommendations have been made to increase their use in industry: an increase of transparency and explainability of genetic algorithms, an increased focus on user experience, better communication between developers and engineers, and visualising algorithm behaviour. t his paper aims to provide insights for developers and researchers of genetic algorithms and engineering design tools. these insights include the attitudes that engineers and students have towards genetic algorithms. the current barriers they face in the design process were explored. a total of participants were recruited for a mixed methods survey. their opinions were analysed thematically as a means of establishing their preferences with respect to engineering design tools and genetic algorithms. this paper provides a number of recommendations for developers and researchers. the contribution of this paper to the domain of evolutionary computing is establishing best practices with respect to the development of genetic algorithms in the context of design engineering. genetic algorithms (gas) are nature-inspired algorithms. they use the process of natural selection through selection, crossover and mutation to search for an optimal solution to a problem. the solutions are driven to optima by a fitness function which dictates which traits are selected for the next generation. some common examples of gas are particle swarm optimisation [ ] , artificial bee colony [ ] , ant colony optimisation [ ] , firefly algorithm [ ] and cuckoo search algorithm [ ] . examples of natural phenomenon gas are colliding bodies optimisation [ ] and gravitational search algorithm [ ] . ) applications: gas have proved to be a powerful tool for optimisation [ ] - [ ] . their application ranges from very simple mathematical formulae to complex systems with many interdependencies. the design of a simple cantilever beam [ ] and elaborate aerodynamic design [ ] showcase the range of applications. to measure the effectiveness of an algorithm, they are often tested against standard benchmark functions such as the ackley function [ ] and constrained engineering problems like a welded beam or a pressurised vessel [ ] . multi-objective optimisation (mo) problems are particularly well suited to gas. many engineering problems can be classified as mo; these designs involve many different trade-offs. it is often challenging for human designers to determine an optimal solution without the aid of a computerbased system. one example of an mo problem where a ga was used successfully is presented by tawhid & savsani [ ] who evaluated their artificial algae algorithm on different benchmark problems to show its suitability for engineering design optimisation problems. an industrial application of mo engineering can be found in aerospace, specifically the design of geostationary satellites. customer demands for higher bandwidth capabilities and longer lifespans [ ] are at odds with the many constraints in place. these constraints include • higher power requirements; • thermal considerations, including hot and cold zones; • the ability to fit in a rocket fairing; and • the ability to withstand vibrations during launch. each of these variables need to be considered throughout the design lifecycle of the satellite. to illustrate the usefulness of gas in this context, berrezzoug et al. [ ] proposed a method which applies a gravitational search algorithm to the design of a satellite by considering the many design variables. the approach proved useful for determining optimal trade-offs between the variables. optimisation problems do not need to be strictly product design based either. the layout of a construction site is another kind of mo problem. offices, equipment and warehouses are among the factors which influence the layout. the objective for any layout is to maximise the time spent on value adding activities while decreasing wasteful activities like transportation or waiting. in addition to this, the safety of the construction workers and engineers cannot be compromised. one attempt at this was done by kaveh et al. [ ] who demonstrate the application of a colliding bodies optimisation algorithm to a construction site layout. their solution demonstrates that a problem with n! combinations can be effectively solved with a ga. the optimisation problems presented in this section are bounded by the constraints put on them by external factors, such as launch conditions for a satellite. in the following section, the constraints that designers face, such as resources and time, will be explored. these factors present barriers for the designers when attempting to optimise their designs. ) the relationship between humans and algorithms: rather than acting as autonomous agents, gas can be integrated in the design process to enhance the capabilities of human designers. in recent years, a growing trend of combining the expertise of designers with algorithms has been taking place. for example, ant colony optimisation was applied to the design process of the layout of train tracks [ ] . the layout can be optimised to reduce the energy consumption of the trains as they travel the tracks. furthermore, flurl et al. [ ] propose a method to allow design engineers to see the effects of their changes on energy consumption in realtime. this method takes advantage of the algorithm's ability to find an optimal solution while allowing the designer to stay in control of the track layout. the push for user-centric design is evident in engineering as well as other disciplines such as architecture. in a survey of architects, % of respondents would like to see an inclusion of a "human-in-the-loop" approach with regard to the software and technologies they use [ ] . furthermore, % of respondents wanted to be able to understand the underlying principles of the algorithm while just over half ( %) would like full control over the process. in an attempt to bring this to fruition, berseth et al. [ ] propose an interactive computer-aided design (cad) optimisation program. it engages with architects by analysing their designs and optimising for a number of variables such as "open space in passages, aesthetic relationships, or building codes." this is akin to the mo problems encountered in aerospace engineering applications such as satellites, but also in the development of rockets. in fact, a user-centric approach was adopted by engineers at nasa [ ] and allowed engineers to evaluate the interdependencies that different systems had to each other with respect to the mission objective. other approaches attempt to rely too heavily on algorithms alone and exclude human intervention. this approach leads to systems either whose complexity is increased or explainability is decreased. explainability is the ability for a developer or user to understand a model's behaviour [ ] . two examples of approaches which rely too heavily on algorithms have been shown when trying to solve mo problems. the first is a symbiotic organisms search algorithm which was developed by ustun et al. [ ] . it is a very recent algorithm that may perform better than other standard ga for certain mo problems, but falls victim to the no free lunch theory [ ] . the no free lunch theory states that for all problems in which a supposed algorithm x outperforms algorithm y, there are an equal amount of problems in which algorithm y outperforms algorithm x. in short, there does not exist an algorithm that will be the best choice in all scenarios. the development and tuning of gas is itself an optimisation problem and gas are developed on a case-by-case basis with their applicability to different situations being very limited. the second example of an over-reliance on algorithms has to do with eliminating the consideration for external factors on the optimisation process. fleck et al. [ ] discuss a method to reduce an mo problem down to a single value. this is a problem for any real-world engineering application. take for example the previously mentioned satellite problem. there are many design variables to consider and their dependencies must be investigated in depth. the lack of explainability would be difficult to justify in satellite development. a need for explainability was also noted by burnell et al. [ ] when incorporating their approach at nasa. by combining human expertise with algorithms, designs that are both optimal and adhere to all design constraints can be produced. this is demonstrated by guo et al. [ ] for bolt supporting networks. users could select from a range of solutions which were fed back to the algorithm to develop a solution that was strong, cost-effective and manufacturable. oulasvirta [ ] considered user-centric design when applied to user interface (ui). one of the key points raised with the approach was that the "designer can steer and redefine the tasks intermittently as results stream in." thus, an optimum between designer and computer also exists; a region in which the algorithm is able to perform the necessary calculations while the human designer can focus on producing a result in line with their vision. the real-time approach is adopted by umetani & bickel [ ] and is applied to automobile aerodynamics. the changes made by users and the effects those have on the drag characteristics of the vehicle can immediately be fed back to the designer. incorporating humans in the optimisation process indirectly involves designers from outside of the design process. this is because engineers do not work in isolation, but rather as a team. adjoul et al. [ ] observed that optimisations in the production phase required experts from both production and design to work together to create an optimal product. the entire life cycle of a product must be considered when dealing with optimisations. an instance of this is probed by kang et al. [ ] while considering the trade-offs faced by customers when purchasing a new car. their techniques "could readily lead to crowdsourced, real-time, manufacturer-feasible design optimization [sic]," which includes customers, designers and engineers. the integration of designers in the design loop has been shown to be possible. the results, however, have been focused on the quantitative aspect of the application. an in-depth thematic analysis of the opinions of practitioners has not been evaluated in all the previously mentioned papers, which this paper contributes to the field. academic literature has shown that the use of gas can add value in industry. however, the best way to do so remains unclear. gaining a familiarity with the way designers work can be used to develop a better understanding of why the uptake remains low. the following research questions were posed: ) to what extent is there a pre-existing sentiment (negative or positive) among practitioners towards genetic algorithm-based design? ) what are the requirements of students, engineers and managers with regards to design optimisation and the design optimisation process? the survey consisted of parts. part was used to gather non-identifying traits about the respondent such as their experience in the field and their roles. part gauged the respondents prior knowledge of the domain as well as their preferred characteristics for design tools. part of the survey had optional, open-ended questions aimed at determining the current state of a design process and the respondents attitudes towards algorithmic design aids. there was no time limit for responses, however, minutes was suggested as an estimate of time for completion. the analysis of the results have been broken down into three parts to reflect the structure of the survey. thematic analysis has been used for part , while parts and can be analysed quantitatively. a total of participants (n = ) answered the survey over the course of days. all participants answered all questions in parts and . some respondents chose not to answer some or all questions in part . the total number of responses per question in that part are given along with the result. the survey was created electronically using google forms. a link to a survey was posted on various social media sites (twitter, linkedin, facebook, reddit) to gather responses; emails were also sent directly to those with known prior domain experience. ethics approval for this study was granted by the swansea university college of science ethics committee (su-ethics-student- / ). participants were asked to categorise themselves based on their current roles. the sum of the responses exceeds as some participants may feel that more than one category applies to them. more than half (n = ; %) of the respondents considered themselves as engineers, with roughly a third (n = ; %) specifically selecting "design engineer." some participants (n = ; %) selected more than one descriptor. participants were asked to state their highest level of education. all participants but one (n = ; %) hold either an undergraduate or postgraduate degree. slightly under half (n = ; %) of participants hold a postgraduate degree. the specific degree was not probed. in addition to their education, respondents were asked to state their length of experience in the field of engineering design as well as their self-declared proficiency. the proficiency was declared on a -point likert scale (from "not proficient whatsoever" to "extremely proficient"). of all participants, just under a third (n = ; %) indicated they had more than years of experience in this field. moreover, most (n = ; %) participants indicated they are at least "proficient" in engineering design. over half (n = ; %) of those would say that they are very proficient while one (n = ; %) participant indicated extreme proficiency in engineering design. respondents were asked how they had heard about the survey. this questions served as a means to determine which platform attracted the most participants. the data is useful for future surveys, however, bears no effect on the analysis of the results of this survey. five (n = ; %) of the participants recruited via email have an existing professional relationship with one the authors. an additional question to determine how familiar respondents were with the field prior to answering was posed. to do this, some common and other, more niche terms were selected by the authors to gauge that prior knowledge. the question listed terminology associated with evolutionary algorithms. the most frequent terms that participants had previously encountered were "genetic algorithm" and "evolutionary programming." both had been selected times. the least frequent terms were "selective search" and "adjoint state method." these terms were selected times and times, respectively. one (n = ; %) participant did not select any terms and none of the participants selected all the terms. the technique used to evaluate the results of the open-ended questions in this survey is thematic analysis. the process behind the evaluation is based on the work of braun & clarke [ ] . the steps outlined have become standard practice to conduct similar research in areas such as psychology, sports science, and engineering [ ] - [ ] . a brief overview of each step is given. ) initially, a general familiarisation of the data is conducted to get a general overview of the contents. a rough idea of codes is written down and used as a starting point for the next step. ) once the data has been familiarised, the process of coding begins, which is the labelling the data that appears interesting. this can be one or two words within the data or a short segment that conveys a narrow idea. ) once the data has been coded, the codes themselves are grouped together in general themes. the relationship between themes is also explored at this stage. ) themes are reviewed at this point. some themes may need to be split, combined or otherwise adjusted. importantly, a pattern must be evident within the theme among the codes. a complete review of the data is also done at this point to bridge any gaps that may have been missed initially. ) themes are concretely defined at this step. again, themes may be restructured to ensure that each theme has one central idea. ) lastly, the analysis of the data is written up. the analysis is broken into individual themes using codes and data to support the arguments. three metrics to ensure the highest quality of analysis are outlined by nowell et al. [ ] and consist of credibility, transferability and dependability. through the realisation of the three metrics, then a fourth metric is fulfilled according to guba & lincoln [ ] : conformability. to ensure that these metrics are being met, nowell et al. [ ] suggest an audit trail is set up so that any researcher could follow the logic. also suggested is that researchers remain critical of their own findings. electronic records of the analysis were shared among the authors. acknowledging internal bias is key to maintaining credibility. in an update on their paper, braun & clarke [ ] describe researcher bias as an inherent component to thematic analysis and point out that it is the researchers who generate the themes rather than the data itself. knowledge of one's own bias is of recommendations provided by castleberry & nolen [ ] . as per the recommendation, bias is discussed later. this part contained five questions which assessed the respondents' preferences with regards to engineering design tools. the criteria are user interface, versatility, robustness, frequency of use in industry, and supporting documentation. the questions were evaluated on a -point likert scale; the participants had the option to choose from "no importance," "some importance" and "high importance." an additional option of "no opinion" was provided for respondents. as seen in figure , the two most important criteria according to participants was user interface (ui) and robustness (ro). both of these criteria had a majority (ui: n = ; %, ro: n = ; %) of respondents mark them as highly important. with respect to ui, the participants declared that it is at least somewhat important when considering design tools. from the answers given by participants, the criteria can be ranked: user interface, robustness, supporting documentation, versatility, and frequency of use in industry. this ranking however does not negate the need for any of the criteria as all had been ranked as somewhat important by the majority of participants. from the thematic analysis, themes were generated and were given broad names to serve as an overarching link: human, product, and technology. the associated codes are visualised in figure . coding could be done on of the answers. the remaining answers contained insufficient detail to accurately assess the meaning and intention of the respondent, or did not answer the question in a coherent manner. the incoherency of answers in this question and following questions had to do with a lack of any sentence structure. the first open-ended question was geared towards answering the second research question. when discussing the current state of their design processes, participants approached the question from different angles. using the generated themes as a starting point, included a human element, from a product perspective and made reference to technology. answers had two themes present. many of the answers that fell under the product theme were heavily focused on the design itself. this included talking about the requirements of the design, refinement and optimisation. participants were also asked to included proportions of their time spent at each stage of the design process. participants gave a breakdown while participant only noted the longest stage of the process. for these participants, iteration/optimisation/redesign takes a significant portion of their time. some participants also included other considerations into the design process such as designer experience, designer preferences and customer/supplier relationships. with regards to customer requirements, participants said that those requirements are used as a starting point for high-level, initial designs. combined with answers that gave design process time breakdowns, this stage takes up about % to % of the process. one participant, a manager, also noted that finding an optimal solution is "highly unlikely" although admitted that solutions could be found that are quite close to the optimum. this is in line with another participant, an engineer, who mentioned multidisciplinary optimisation (mdo) which invariably results in compromises. these in turn lead to lessthan-optimal designs. of course, this is acceptable as long as the design requirements are met. ) question : what barriers do you have to overcome during the design process?: this questions was answered by participants. again, this question was related to the second research question. most (n = ; %) of the participants' answers in the second question fell under the product theme. participants explicitly stated that cost was a barrier to their design process. other resources, such as time and processing power were also mentioned. previously, it was noted that some participants use the customer requirements as a starting point for their initial design. for one participant, this was incidentally their biggest obstacle. this lends itself to another problem, where the customer does not have clear requirements. both optimisation algorithms and engineers rely on a clearly defined objective around which to construct their solutions. one engineer relayed that selecting weights for a fitness function was a barrier to their design process. this is indicative of an over-reliance on the expertise of the engineer and a lack of technology meeting its potential. spending extra time determining weights takes time away from engineers adding value in their area of expertise. both a student and an engineer mentioned competing design requirements as a barrier. incorporating conflicting requirements can be challenging, especially when, as mentioned earlier, requirements can be unclear or ill-defined. another two participants, a student and a design engineer, mentioned their own knowledge as a limitation to the design process. for the student, being confident enough to be able to get their design from a mental model to a cad model was a hurdle. for the engineer, the "learning curve of toolsets" was one of the obstacles. these two answers offer insight into which aspects of the design process can be improved with (better) technology and which are subject purely to engineers. two instances of trust were brought up: one from an engineer and another from a manager. the first had to do with trust in the technology itself, specifically design simulations. the results from simulations must be accurate so that engineers can make informed decisions about the design and ultimately the final product. the second instance of trust was related to the participant's peers. getting buy-in from new colleagues was mentioned as a barrier. for this participant, trust was instilled as a result of the outcome of the project. this is one manner in which gas can gain an engineer's trust, although it would still require a high level of trust from key early adopters. ) question : what comes to mind when you think of evolutionary algorithms?: this question was answered by participants. the intention of this question was to gauge whether respondents have any prejudices or preferences towards algorithms as a part of the design process. this question was in line with the first research question. the answers in this question came under two themes: technology and human. the count for each was and respectively. answers were not coded: of these, pertained to biology and did not fall in among the themes while answer was too short to accurately determine the respondents intention. the answers which related to biology were not put into a theme because the creation of an additional theme did not seem appropriate for out of total answers. two managers expressed a negative sentiment towards the term used in the question: evolutionary algorithm. the first participant stated that it is "over-rated in practice" and preferred more rudimentary optimisation methods; pattern search was given as an example. the second participant questioned the ability for evolutionary algorithms to add value. both participants point to a hurdle that new technology faces: convincing stakeholders that learning a new technology or system is worth the time investment. this sentiment was echoed by an engineer when responding to the last open-ended question. by noting the shortcomings of the current state of gas, a clear pathway to wider adoption can be determined by addressing their concerns. other participants related the evolutionary algorithm to an automated processes or global optimisation. three different participants mentioned artificial intelligence (ai) and machine learning (ml). seven participants used a variation of selective process, biology and survival of the fittest in their answers. these answers indicate that developers of these algorithms should include a succinct explanation to let engineers have a better understanding of their mechanisms. ) question : do you trust the designs produced by automated optimisation algorithms? explain your answer.: this question was answered by participants. as with the previous question, it was aimed at answering the first research question. participants could very easily be categorised in this question. participants expressed varying sentiment of doubt regarding the result produced by an algorithm. as an example, participants noted that they prefer to check the results of an algorithm by hand. one design engineer extended this by stating that the results would have to be validated by a real world test. this is an example of maintaining the human element in the design process. keeping the human element in the process is threaded in nearly every answer. another design engineer noted that "there are some processes in optimisation that require experience and intuition," which is a direct call to designer expertise. likewise, one student incorporated the entire lifecycle of the product in their answer; cost, manufacturing and feasibility for human use. a similar sentiment was shared by another student in that some results may be outside of the constraints of the design space. three participants stated an outright trust in results generated by algorithms. one of these respondents, an engineer, states that the results are "usually overchecked." this is contrary to another engineer's answer, who stated "a 'blind' trust [in automated optimisation algorithms] is a bad approach." both sides point to the need for a proper explanation of the potential applications of these algorithms as well as the limitations. this question also revealed some feelings that designers have towards optimisation algorithms. designers will not trust the final design unless they can understand the process the algorithm took to yield that result. ) question : do you think a computer-based algorithm could help your design process? explain your answer.: this question was answered by participants, although one answer can be discarded as the respondent simply stated that the question was not applicable. this question was related to both research questions. two thirds (n = ; %) of participants expressed a positive sentiment towards working with algorithms in their design process. much like the previous question, the degree to which participants wanted to incorporate this technology varied. one manager stated that they have already incorporated optimisations into their process. a student declared that they would use it only for the initial design stage. the development of this technology should be able to cater to those who want to use it for one or all parts of during their design processes. one design engineer gave requirements in anticipation of such technology being incorporated in their process. the most important requirements for this participant was a properly designed ui and a link to other engineering tools. a seamless experience allows engineers to focus on designing rather than debugging. it also avoids user frustration. ) question : do you have any reservations about implementing more computer-based assistance in the design process? explain your answer.: this question asked participants if they have any reservations with regards to implementing more optimisation algorithms in their design processes. it was related to the first research question and was answered by participants. each answer could be attributed to the human theme, though through various degrees. one student drew comparisons between other software such as cad and computational fluid dynamics, noting that the design process is already heavily computer based. an engineer and a student are concerned about the reliance that future engineers and designers will have on systems like gas. the engineer mentioned that these algorithms have "disengaged the brains of engineers" which threatens a long-term consequence of engineers that have poor design experience. two participants, a student and an engineer, cited job security as a reason why they would not want this technology implemented. this is a very real concern that needs to be addressed by properly explaining the intent of developing these tools. another engineer was very supportive of the idea, mentioning that they have been advocating for this kind of technology for the last years. it is an accurate reflection of the challenge of getting new technology to be adopted by individuals and by organisations alike. ) open-ended question summuray: the amount of mentions per theme are summarised in figure and figure . discrepencies in theme mentions can be explained by a varying number of participants in each category. the number of mentions also exceeds the total number of answers as some answers contained more than one theme. a common thread throughout participants responses is that there is a question of trust towards gas within industry. perhaps surprising is that the key to gaining this trust is not producing good results, but creating algorithms which explain the process they take in reaching a result. participants have expressed a desire to continue to remain in the design loop. this is at odds with the motivation of a portion of the ga community of removing humans from the loop [ ] . it is clear we need to take a different approach to increase industrial uptake. the participants in this study have demonstrated through their answers that there is a general distrust towards gabased design in industry. % of answers expressed doubt when discussing whether designs produced by an optimisation algorithm could be trusted. their reservations have to do with the unproven state of these algorithms in their own personal experiences. however, respondents also recognise the potential of this technology, with % of respondents saying they could see the value of integrating gas somewhere in their process. of the respondents that expressed doubt, % of them noted that these algorithms could also help their design process. separately, participants noted that the inclusion of human expertise is vital for adoption. much to the surprise of the authors, the answers between the different groups (students, engineers, managers) and experience levels did not vary significantly. this can be seen in figure and figure . the different groups shared the same thoughts across a variety of questions, especially when considering the two research questions. the most notable example of this is that both a student and an engineer were concerned about their jobs being replaced or made redundant by automation. optimisation and iterative design are significant portions of the design process. when discussing their design process and the time spent at each stage, one participant said that in their experience "the detailed subsystem design is usually the longest stage" and that "an iterative evolutionary algorithm would speed up this process." this is in conjunction with the previous statement that this stage takes up % to % of the total design process time. recognising that trust is important in the development of new algorithms and the integration of such algorithms in industry is key to their adoption. participants noted that trust plays a big role in the adoption of new technologies. one participant had a clear mistrust of new algorithms. others mention multiple times that the need to be able to review the results and the decisions that an algorithm takes is a priority. when asked whether they had any reservations towards optimisation algorithms, three participants explicitly said yes. one of these participants went on to ask a series of questions about the ethics of the decisions made by an algorithm. questions included "who would be liable for a death or damage caused by a design made by this algorithm?" and "are we going to write a decisions rules book?" which clearly demonstrates that designers are not only aware of the decisions they make with respect to their design, but also to the wider consequences. the sophistication of the design process was also different across the range of participants. two participants had a more traditional approach when refining their design, opting for "trial and error" and "one factor at a time." these approaches are useful for exploring the entire design space and are a mix between designer experience and technology. however, they can be very time-consuming processes, especially on complex designs. while a design of experiments (doe) is generally suitable for proof that a global optimum has been achieved, a trial and error method is not. v. recommendations the participants in this study have shown with their answers that there is one key element which will determine the scale of adoption -trust. this principle is used as a foundation for the following recommendations. by trusting designers to know what's best for them, developers of new gas should engage with experts in creating solutions aimed at solving their optimisation problems. while the development of new algorithms is important in addressing different optimisation challenges, the application must go beyond benchmark tests and into industry for that algorithm to realise its potential. moreover, the reservations that participants had towards these algorithms point to a general need for algorithms to have suitable explainability and transparency. these criteria correspond closely to the requirements set out by those researching the ethics and law of ai [ ] . the domain of evolutionary algorithms could coopt the proposed regulatory framework of ai as a starting point as these technologies become more prevalent in industry. throughout the survey, the need for human involvement in the development process of gas is brought up; it demonstrates a need for a user-centric approach. human-computer interaction (hci) is the field of study which concerns itself with researching the relationship between users and digital technology. this can first be observed in part of the survey, where respondents identified a good ui as the most important factor when considering a design tool. the expectations from designers is that any additional tools that are made must integrate into their existing design process. this is articulated by a participant who needs an "intuitive set-up and an interface to existing tools." this can be seen as a direct answer to the second research question which enquires about the design requirements of domain experts. these tools need to also cater to novice users such as students. a user-friendly interface can lower the barrier of entry to gas. an engagement between hci researchers and ga researchers can further these algorithms towards a higher adoption rate in industry. the need for solutions to be developed in conjunction with the designers who will eventually be using these tools is evident in the answers of participants. integrating constraints in the design optimisation process was a recurrent subject among participants' answers. simplifying the problem down to something that could be modelled and optimised while maintaining a feasible enough design is a challenge one of the participants cited. the human aspect of design was also brought up by the participants by referencing the necessity for designer expertise in more complex designs. one of the participants also talked about aesthetic constraints. this is a constraint that cannot be modelled and relies solely on the experience and preferences of the designer. moreover, it should also serve as a reminder that any engineering design tool developed is not meant to cover every single aspect of the design process. the expectations of engineers needs to be set by researchers who develop these tools to determine what constitutes "state-of-the-art" with respect to this technology and what the limitations are of these techniques. analogously, gas are not the swiss army knife of design tools. engaging with designers and building their trust in gas can be done with the help of visualisations. a key aspect of building trust is to develop a level of understanding of the algorithms. a simple manner in demonstrating the performance of an algorithm is to visualise the resulting solution after each generation. this is especially useful when comparing two or more algorithms. if the algorithms themselves are considered as tools, then this would give designers an easy manner to comprehend which algorithm is better for their application. for some designers, it would also be beneficial to see the different solutions that a ga can produce. this can be especially useful for designers who also need to consider aesthetic constraints. it also leads to another consideration in the development of gas. the visualisation of algorithms is mentioned in the introduction section with work involving construction site layouts [ ] . as recommended by castleberry & nolen [ ] , personal bias is addressed. every effort has been made to mitigate the effects of bias when analysing, presenting, and discussing the data. with regards to pre-survey bias, the design of the study along with the questions were reviewed by the authors and amended to keep the study as objective as possible. as this survey was done entirely online, interview bias was not present. during the entire duration of the survey being available to respondents, the answers were not gleaned to prevent any bias during the analysis stage. of the respondents that took part in this study, could definitively be attributed as a professional connection to one of the authors (through answers provided to the question "how did you hear about this survey?") which introduces some level of bias. this was minimised by not asking respondents for any identifiable and traceable details. moreover, not a single answer contained any identifiable words or phrases. under a restriction-free scenario, participants for this study would have been interviewed in-person; due to covid- , this could not be done. this did mean that the participants could not be prompted further when discussing their answers. as an example, some of the answers could not be coded due to their brevity so further detail from respondents would have been beneficial. in the future, video conferencing could be used instead of face-to-face interviews. a total of participants were recruited through digital means to answer a survey. thematic analysis was performed on open-ended questions, which yielded major themes: human, technology, product. with regards to their current design processes, respondents noted that optimisation takes a significant portion of their time. respondents were generally aware of the source of inspiration from which evolutionary algorithms take their names, but lacked an in-depth knowledge of the subject. a majority of participants stated that they would implement these algorithms in their design process, although some still held reservations about their implementation. with respect to the two research questions posed, participants have demonstrated through their answers that there is a general distrust towards ga-based design, yet there is also an acknowledgement among participants that these algorithms could benefit the engineering design process. trust in these algorithms was one of the barriers to adoption. cost, manufacturability, and knowledge limitations were also mentioned as hurdles in the design engineering process. practitioners of ga tools want to understand how the algorithm made its decision. making tools for designers that are intuitive and whose functionality can be accessed easily by engineers is paramount; future ga interfaces should maximise engagement with designers. a clear communication channel between researchers and their end users can increase the adoption rate. trust is an important factor for designers. by allowing engineers to be in control of the process, engineers will be able to build a level of trust with the design tools. likewise, a human-centred approach will demonstrate to designers that these tools are not there to replace them. acknowledgment j.v. would like to thank members of the epic cdt for their continuous support. the particle swarm optimization algorithm: convergence analysis and parameter selection a powerful and efficient algorithm for numerical function optimization: artificial bee colony (abc) algorithm ant colony 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three-dimensional flow for interactive aerodynamic design algorithmic strategy for optimizing product design considering the production costs form+ function: optimizing aesthetic product design via adaptive, geometrized preference elicitation using thematic analysis in psychology the sage handbook of qualitative research in psychology routledge handbook of qualitative research in sport and exercise exploring challenges of assessing students' errors in engineering problem solving; a thematic analysis thematic analysis: striving to meet the trustworthiness criteria fourth generation evaluation reflecting on reflexive thematic analysis thematic analysis of qualitative research data: is it as easy as it sounds? taking the human out of the loop: a review of bayesian optimization white paper on artificial intelligence key: cord- -vfnbs jn authors: rebmann, terri; wagner, william title: infection preventionists' experience during the first months of the novel h n influenza a pandemic date: - - journal: american journal of infection control doi: . /j.ajic. . . sha: doc_id: cord_uid: vfnbs jn background a novel strain of influenza a (h n ) was identified in april and developed into a pandemic by june . this rapid and unexpected event had enormous implications for infection preventionists (ip) internationally. lessons learned from this event should guide future pandemic planning efforts. methods focus groups were conducted at the association for professionals in infection control and epidemiology, inc, (apic) conference to evaluate ips' experience with the novel h n influenza pandemic and assess their perceived needs related to novel h n topics and products required for future education and reference materials. results forty ips ( from the united states and international) participated in the focus groups. needed reference materials identified by attendees included infection prevention guidance for nonacute care settings; occupational health polices; and brief, multilanguage patient/family educational materials. educational topics on which ips need to be trained include isolation precautions/personal protective equipment recommendations for novel h n patients, coordination between hospitals and community response agencies, and surge management. the rapidly changing and conflicting recommendations related to patient management made responding to this event challenging. ips require synthesized infection prevention guidelines developed in a concise, real-time format. conclusion ips must continue to partner with public health and other response agencies to address gaps in pandemic planning. infection preventionists' experience during the first months of the novel h n influenza a pandemic a novel strain of influenza a (h n ) was identified in late april . within a single week, the world health organization (who) raised the pandemic phase from to . the who pandemic phase indicates that there is sustained human-to-human transmission of a pathogen in at least countries and that a pandemic is likely imminent. the centers for disease control and prevention (cdc) reported the first case of laboratory-confirmed novel h n in the united states on april , ; a second case was reported days later. on april , the cdc activated its emergency operations center in response to the novel h n outbreak; days later, on april th, the cdc declared a public health emergency. early cases were identified in texas and california, but the outbreak soon spread widely across the united states. by may , , the cdc deployed % of the strategic national stockpile to aid states in responding to this event. on june , , the novel h n outbreak was officially declared a pandemic by the who. infection preventionists (ip) were on the frontlines during the early phase of the novel h n outbreak, helping health care agencies develop policies and procedures to respond to this rapidly evolving event. the surge of infected individuals and ''worried well'' taxed hospitals and health care agencies around the world. prior to being declared a pandemic, the novel h n outbreak grew exponentially in the weeks prior to the association for professionals in infection control and epidemiology, inc, (apic) annual educational conference and international meeting. this unexpected outbreak had enormous implications for ips internationally because infection prevention guidance related to novel h n patient management, such as recommendations on isolation and personal protective equipment (ppe) usage, came out sporadically from various organizations, including the who and cdc and health departments across the united states. the ips who responded to this event in the early months of the outbreak had unique experiences that may provide lessons learned for other ips and should guide future pandemic planning efforts. the purposes of this study were to evaluate ips' experience with the novel h n influenza pandemic and assess their perceived needs related to novel h n topics and products required for future education and reference materials. the aims are to understand better the novel h n pandemic and develop educational and planning/reference materials to aid in this and future infectious disease outbreaks. this project was conducted to support apic's goal of providing timely information relevant to novel h n and to complement the work of apic's emergency preparedness committee. the authors developed the questions for this study. all members of apic who were registered for the apic annual educational conference and international meeting were invited to participate in the focus groups, regardless of size or functionality of institution or work location (within or outside the united states). the only inclusion criteria was being involved in the direct response to the novel h n flu pandemic, defined as individuals who work in a hospital, health care, or public health agency that has handled/ managed at least confirmed positive case of novel influenza a h n in . the authors recruited potential participants via e-mail. one focus group met each day in a meeting room located in the conference center site on june and , . snacks were provided to the participants during the focus groups. the nominal group method was used to elicit information on the topics of interest. the focus group method (ie, opening-ended questions) was used to elicit details from participants' experience with the novel h n influenza pandemic. participants were informed that information collected would remain anonymous and that all responses were voluntary. focus group sessions were audiotaped, and the digital recordings were transcribed verbatim. content analysis included identifying, coding, and categorizing participants' response to the questions of interest. in addition, major themes that emerged were identified and categorized. subjects' demographic data were obtained for descriptive statistics. in addition, participants were asked to complete an -item survey containing items related to the novel h n flu pandemic, such as hospital or agency protocols for worker protection, isolation, and ppe usage during the event. the institutional review board of saint louis university approved this study. apic funded the costs of the food and meeting location for the focus groups; saint louis university covered the costs of data transcription. quotations that characterize the major themes are reported. the words enclosed in brackets of the quotations are used to explain the respondents' quotes and are not the participants' words. all individuals registered for the annual educational conference and international meeting were contacted. forty participants took part in the focus groups; the first focus group had participants, the second had , and the third had . most focus group participants ( %, n ) reported that they resided in the united states, spanning states; participants were from facilities outside the united states (australia, the united kingdom, and canada). most attendees worked in a hospital ( %, n ), public health agency ( %, n ), home health ( %, n ), or ambulatory care setting ( %, n ). the facility bed size ranged from (a small, rural facility) to , (a large, international multiagency health care system). approximately half of the attendees worked in an urban area ( %, n ); only % (n ) were from a rural area. the majority of attendees was female ( %, n ) and aged years or older ( %, n ). approximately half had a master's degree or more education ( %, n ). twentyseven participants ( %) were certified in infection control. a full description of the participants' demographic characteristics is reported in table . the participants identified many types of reference materials and education topics on which the participants believed ips need to be trained for future novel h n or other pandemics. the reference materials/ products that received the most votes during the nominal group method portion of the focus groups are outlined in table . the education topics that received the most votes during the nominal group method portion of the focus groups are outlined in table . in addition, a number of themes emerged from the focus groups related to infection prevention emergency management issues encountered during the novel h n influenza pandemic in spring . one of the most frequently cited topics of importance to focus group participants was the lack of infection prevention guidance for alternate care sites and nonacute care settings such as physician offices, ambulatory care clinics, long-term care, nursing homes, and others. as one participant noted, ''all the information that came out was basically for schools or acute care.'' other participants stated that it was difficult to know how to manage novel h n patients in this setting without guidance: one specific occupational health issue that focus group participants felt needs to be addressed is how to manage or prevent ill health care providers coming to work sick. as one participant stated, ''as much as you tell [health care workers] not to come to work sick, they still come.. we cannot allow employees to work sick, even with seasonal flu.'' money may be one potential reason that employees may work when sick. as one participant explained it, ''sometimes people will say, Ôi can't afford not to work.Õ '' another focus group participant agreed and added, ''it's hard to keep people off work when they are sick.'' focus group participants indicated that more administrative support and better human resource policies are needed related to furloughing staff and sick leave practices during pandemics. as one participant explained it,''we need [administrator's] support in saying that, when people are exhibiting symptoms, then they can't work in patient care.'' another participant agreed and added, ''of course the hospitals don't want to hear that you're not going to let the staff work.'' one focus group member stated that her human resource department was hesitant to furlough employees due to novel h n because it would cost the hospital money. she was told by human resources, ' compensation] would not cover occupational exposures to [novel h n ] because it's also out in the community.'' there was also some confusion about and hesitancy to enforce the cdc-recommended -day furlough period for staff infected with novel h n . as one participant stated,''we had more people who wanted to come back sooner than days.'' occupational health issues were present in the community, as well. companies were hesitant to allow employees to return to work without some reassurance from the medical community that the employee was no longer contagious. as one participant explained, ''we had employers calling up the emergency departments and saying, Ôi want this person tested, and they need to have a negative before we're going to allow them to come back to work.Õ '' this created a lot of extra and unnecessary work for hospitals and health care agencies. one issue that participants found particularly challenging was the difficulty in maintaining staff compliance and trust in the face of changing and conflicting practice recommendations/standards. the participants were asked which sources they used to obtain clinical information and infection prevention guidance about novel h n during the spring of . all the participants reported that they obtained information about novel h n from the cdc ( %, n ); other frequently cited sources of h n information included state health departments ( %, n ), the who ( %, n ), and apic ( %, n ). focus group participants indicated that novel h n clinical information and practice recommendations changed rapidly in the spring of . as one participant noted, ''the case definition changed like times during the course of the event for us.'' these rapid changes made it difficult for focus group participants to stay abreast of the latest recommendations. as one focus group member stated, ''the rules change so often, it's hard to keep up.'' another agreed and added, ''from o'clock in the morning until o'clock, [the recommendations were] totally different.'' not only were the recommendations changing rapidly, but many of the response agencies and professional organizations distributed conflicting guidelines. many focus group participants had a difficult time trying to interpret the inconsistent guidance from various agencies. as one participant explained: ''our biggest problem was that [these conflicting guidelines are] very difficult to interpret, especially when we go from cdc to state to local health departments. so we're trying to coordinate these efforts, and it's a constantly moving target.'' table . reference materials needed for current and future pandemics topics that require development into quick reference materials ranked by order of importance* infection prevention guidance for nonacute care settings (ambulatory care, home health, physician offices, and others) infection prevention guidance related to occupational health issues evidence-based information for physician education patient and family educational materials that are brief (eg, -page fact sheet) and available in multiple languages patient management materials that are brief (eg, patient placement/isolation, ppe use, and others) isolation precautions materials that are brief and simple: electronic format preferred communication procedures when supplies run out infection prevention guidance for pediatric facilities resource management tool for supply allocation during a variety of events screening tools and forms that are simple to use algorithm/check list outlining steps of an outbreak investigation *order of importance determined by the nominal group method. one focus group member stated that she found it works best if you let staff know up front that the information and recommendations will be changing rapidly. as she explained,''i say to everybody, Ôthis is fluid, this is going to change every day, so don't expect what i say today [to be] what i say tomorrow; expect this to be changing.Õ '' one focus group participant indicated that the rapid changes in recommended practice did not pose a problem at her facility. as she explained, ''our staff was great. they just said, Ôwhat is [the recommended practice] today? just tell me what it is.Õ '' however, this facility seemed to be the exception. the general consensus from focus group participants was that the rapidly changing and conflicting recommendations caused confusion among health care professionals. as one focus group participant noted, ''we [ips] understand why these [practice recommendations change], but i'm not always sure that our staff do.'' the focus group participants indicated that this confusion caused many health care providers to question the credibility of the ips. as one participant explained: ''it's very disconcerting for ips to have to constantly put out different messages. you are constantly sending out different messages to your staff, and, after awhile, they say, Ôoh, they don't know what they're talking about.Õ it's very difficult [to maintain] credibility for your department.'' another participant agreed and added: ''i think the difficulty was getting the staff to [trust you]. because, you know, here you started out with [one recommendation], and then you're telling them that now [it's changed], and i think that was really hard for staff. i think they're still having a hard time trusting that we're telling them the right thing.'' the focus groups participants stated that they felt the early response to novel h n was very positive in terms of staff's adherence to infection prevention. as one participant stated: ''i was amazed. i never saw more people wash their hands. i didn't have to tell one person to wear [a mask]; they were all putting them on. they handled the situation really very well. it was amazing to me how well [staff] pulled together. for the first time in a long time, everything i said [to do], they did.'' however, as the event wore on, the focus group members noted that staff compliance with infection prevention started to wane. as one participant stated, ''it's hard to keep staff vigilant in the midst of any outbreak.'' another agreed and added, ''we're already getting a little bit less vigilant. our protective measures are not there like they should be, and we had cases identified last week.'' the focus group participants stated that they believed health care workers' perceptions of the severity of novel h n led to poor compliance with ppe. as one participant stated, ''many of the staff decided not to wear ppe with the idea that they wanted to get the flu, but they wanted to get mild flu, so they wouldn't get [a more virulent form of disease] in the fall.'' however, this did not hold true for staff compliance with influenza vaccination. many focus group participants reported that they believe health care workers will be more eager to get vaccinated for influenza this year than in previous years. one participant stated, ''what i'm thinking of are those employees who refuse to ever get the flu shot.. when the h n vaccine comes out, i know they're going to be the first in line.'' this increased compliance with seasonal influenza vaccine is already occurring in areas outside the united states. as one participant explained, ''it's our flu season now in australia, and what we've found is that those people who usually don't want the flu vaccination are now standing at the door wanting flu vaccine.'' focus group participants indicated that communication was one of the biggest challenges and most timeconsuming aspects of responding to the novel h n pandemic. focus group participants indicated that the effectiveness of communication varied greatly from location to location. a few focus group participants stated that there was good communication between departments in the hospital and between the hospitals and health departments in the region. others, however, indicated that there were gaps in communication. one participant described the following: ''when i worked in jersey, we had a really good rapport with the department of health. we had meetings together, we planned together. so, there was communication. working in florida, i don't see that communication as much.'' another participant stated: ''what we found is that there's a huge gap in communication. i just felt that there was a disconnect, that we weren't as fluid as what i had seen in the past.. there wasn't that open communication. [information was released on] kind of a need to know basis.'' one gap in communication identified was between hospitals and physician offices. as one focus group member explained: ''there's no communication from the hospitals to the physicians in their offices. we had to end up sending things by snail mail because physicians-even though [they had an e-mail account] in the hospital-they didn't activate it, so.. how do you even get the information out?'' focus group participants reporting effective communication indicated that it involved frequent updates between departments and directors and between other hospitals in the region or their health care system. one participant described it this way: ''i think one of the things that i found extremely helpful-and i think was critical-was that, initially, we had huddles every day. everybody got together to [discuss the response].. and that huddle twice a day was so productive in disseminating the information.'' many focus group participants described very frequent communication between hospitals and health departments. one focus group member stated, ''[all the hospitals in the region] actually had daily phone calls with the health department at o'clock.'' another stated that,''i had meetings during the day for the department of health in the region.'' the frequent meetings required a lot of time, as evidenced by one participant's comment, ''i was on phone call conferences for at least hours a day, even on the weekend.'' devoting so much time to communication meant that focus group participants had to temporarily suspend routine duties. as one focus group member stated, ' communicating with patients and patients' families proved to be very difficult during the novel h n pandemic. focus group participants reported that information was released and was being changed very rapidly. this led to a lot of confusion and questions from patients and family members. the focus group participants indicated that it was essential to have patient educational materials available to address basic questions about novel h n . one of the most frequently cited gaps in this area was related to a lack of materials translated in multiple languages. the following quotes from participants explain the challenges focus group members faced: ''one of our biggest problems was getting information out in various languages. we have a lot of people asking us for information. obtaining sufficient numbers and the correct type of supplies is challenging during any large-scale event. the focus group participants indicated that there were a variety of issues related to obtaining supplies during the early part of the novel h n outbreak, even before the who declared the event a pandemic. as part of a survey distributed before the focus group started, participants were asked whether or not they requested supplies from a local, regional, or national agency; approximately half ( %, n ) reported that they had requested resources. approximately one third of the participants ( . %, n ) reported that they received supplies from the strategic national stockpile (sns). those who requested supplies versus those who received them were not congruent; of the participants whose facility/agency requested supplies, less than half ( . %, n ) actually received them. in addition, % (n ) of participants whose facility had not requested supplies received them. access to supplies was inconsistent among the focus group participants. one participant stated, ''we never had a problem with supplies,'' whereas others reported having trouble getting transport media for laboratory testing, masks, n respirators, disinfectant wipes, oseltamivir (tamiflu), and other products needed for infection prevention. focus group participants reported that supplies were back ordered and that companies could not provide hospitals with what they needed in a timely manner or limited the amounts that hospitals could order. outside the united states, focus group members had similar problems trying to obtain supplies. as one participant explained, ''we had the same problem here [in australia] with manufacturers.. they started to limit [the number of supplies you could order]. '' the lack of supplies or access to the wrong type of supplies had infection prevention implications in terms of making the response to novel h n even more challenging. as participants described it: ''[one] thing that was in really, really short supply was viral transport medium. our local public health department was getting us a day for awhile when we were in the scary part of it,. and so we were not able to test a lot of patients.'' ''we couldn't get our disinfectant wipes. they were back ordered. i said, Ôwait a minute. we have got to be able to clean this place and wipe things down and take care of our equipment and take care of our staff. what do you mean we don't have wipes?Õ but it gets back to our suppliers [who] don't keep it [in stock]. all of the sudden you have an outbreak situation, and i feel very vulnerable that whatever is the next pathogen or if this one comes back in the next wave this fall, what are we going to do?'' ''we had access to a municipal stockpile of tamiflu-which was like doses-which we blew through because everyone was freaking out, and there were so many contacts [who needed it]. after that we were told to go through our local distributors to get tamiflu. well, that was on allocation, and we were only able to get like doses per day, which was just enough to do our inpatients. and there was quite a gap before the strategic national stockpile was relocated and there was any release of [tamiflu]. so we couldn't get it, even if we wanted to pay however much for it. we couldn't get it.'' ''we had a lot of tamiflu, but we didn't have a lick of pediatric suspension tamiflu.'' ''i was really concerned about having enough tamiflu for my staff because, without my staff, i can't take care of a surge of patients.'' theft of supplies was also an issue reported by the focus group members. focus group participants reported that boxes of masks and respirators would disappear quickly in the hospital, presumably used or taken by visitors. some facilities even reported entire pallets of supplies being stolen from the hospital. one solution that focus group members identified during the response to severe acute respiratory syndrome (sars) and the novel h n pandemic was to keep supplies under lock and key. ''our [supplies are kept] off-site too, and, up until this situation, they would take these huge pallets and leave them on the loading dock. that's where ours were stolen from. we had several pallets of things stolen; not just masks, but gloves and so forth. we resecured and we rethought that out, and we have a new policy and procedure in place for that, and it's much more secure than it was prior.'' focus group participants expressed frustration with the way mutual aid agreements were managed during the early wave of the novel h n pandemic. many participants indicated that existing mutual aid agreements were not honored, which left the focus group members' facilities on their own in terms of obtaining resources and supplies. the infection prevention supplies with which the most focus group participants had difficulty during response to novel h n were masks and respirators. numerous issues arose in relation to masks and respirators, including running out of supplies, obtaining the incorrect supplies from regional or national stockpiles, not knowing which type of mask or respirator to use when caring for novel h n patients, and logistical issues in needing to fit test a large number of staff in a short period of time. participants were asked a series of questions related to mask and respirator usage during response to novel h n as part of the survey distributed at the start of the focus groups. one quarter of participants stated that their facility ran out of respiratory protection during their response to novel h n ( . %, n ). as one participant stated,''we didn't have enough n s. there was a problem with our regular n s to begin with. they were back ordered before this even started.'' in addition, many health care staff did not understand why their facility could not obtain more n respirators. as one participant described it, ''it was so frustrating because you were looked at like you could just turn on the key to get however many n s were needed. [the staff thought], Ôjust go order them.Õ. and it doesn't work that way.'' approximately one quarter of the participants ( . %, n ) reported that they implemented a policy to reuse respiratory protection during the novel h n outbreak to conserve supplies. most implemented the reuse policy before running out of supplies ( . %, n ); approximately one third reported that they depleted their stock of respirators before implementing a reuse policy ( . %, n ). focus group participants discussed the challenge of obtaining adequate supplies of respiratory protection during the initial wave of the novel h n pandemic. as one participant stated,''[we] ran out of [n respirators] pretty quickly. within that first couple of days, we reordered them, but they were on back order.'' some focus group members stated that respirators were available in their facility, but the sizes and/or styles did not address the staffs' needs. one participant described her experience: ''we had a lot of respirators available, but we ran out of m small size quickly and couldn't get anymore. we couldn't even evaluate whether the strategic national stockpile had that size and style. even if it had, it wasn't released to us, so we were stuck and had to scrounge trying to find that size.'' the lack of sufficient and appropriate supplies of respiratory protection led to unexpected challenges and suboptimal situations. one focus group participant stated that, '' [staff] were putting the wrong size [respirator] on because we didn't have the right size to fit them.'' another participant described the situation in her institution: ''one of the hospitals that i worked at had ppe issues in that they had decided to go with a regular conflicting guidelines related to isolation, mask, and/or respirator use focus group participants stated that it was very difficult to determine appropriate isolation and ppe use for novel h n patient management. most of the participants ( . %, n ) reported that they used a n respirator or equivalent as respiratory protection for staff, . % (n ) used an n respirator with a surgical mask on top of it, and . % (n ) had staff wear only a surgical mask. of the participants whose facilities had staff wear only a surgical mask when caring for novel h n patients for routine practice, % (n ) reported that staff were instructed to wear a n respirator or its equivalent during aerosolizing procedures. one third of all participants ( . %, n ) reported that their facilities changed ppe use guidelines for staff midway through the response to novel h n in spring of ; one third ( . %, n ) also reported changing their isolation precautions midway through the event. almost all of the facilities that changed ppe use also changed isolation precautions midway through the event ( . %, n ). most facilities used airborne and contact isolation ( . %, n ) or airborne isolation alone ( . %, n ) for novel h n patients. few facilities used droplet precautions alone ( . %, n ) or droplet and contact isolation ( . %, n ). of the facilities that chose to use droplet or droplet and contact isolation for novel h n patients (n ), almost one quarter of them ( . %, n ) used airborne precautions during aerosolizing procedures. the majority of participants ( . %, n ) reported that their facility recommended staff wear eye protection in addition to other ppe when caring for novel h n patients. focus group participants indicated that one of the hardest decisions they had to make during response to novel h n concerned whether to have health care staff wear a mask or respirator when caring for potentially infected patients. as one participant stated, ''[there were a lot of] questions about masking, whether to use a n or just the surgical mask.'' focus group members discussed the lack of scientific evidence available to guide decision making and the conflicting recommendations provided by the cdc and who. as one participant stated: ''our physician champion in our system was very distraught over the conflict between the cdc and who and when you use the respirator versus [a mask]. he felt that the science we were seeing supported what the who was recommending: the mask. and then we had individuals within our system [who didn't agree], and our system health care epidemiologist was very upset because we always follow the cdc recommendations.'' another participant indicated that the lack of scientific evidence led her hospital to take the most cost-effective approach: ''one of the reasons we stayed with the surgical mask during this outbreak was because i couldn't really justify for my chief financial officer the cost of the n over the surgical mask because i had no evidence to back anything up.'' switching recommendations/practice midway through the response created unique challenges for the focus group members. participants reported that health care staff were hesitant to switch from using a n respirator to a surgical mask because of concerns for personal safety. focus group participants reported that switching practice midway through the response also contributed to staff's confusion and question the credibility of the ips as was previously mentioned. many hospitals also shied away from using infection prevention practices that were different from the cdc recommendations. focus group participants explained their experiences as follows: ''[we had trouble] when we tried to switch from n s to regular surgical masks.. some institutions would not accept a recommendation that was different from the cdc's.'' ''[the staff think] Ôthe hospital down the street that has [n s] must love their employees more because they were able to provide them, so why should i go to work [where they won't provide n s]?Õ '' ''[one] thing that we looked at was the legislation from our occupational health and safety act. if we didn't offer [staff] the highest protection and then the staff got exposed, would we then be open to litigation because our health and safety office says, Ôdo this?Õ we're telling them to do that [ie, wear a surgical mask] when we could have offered them the n .'' fit testing is the process of verifying the adequacy and proper fit of a respirator for health care worker use. the occupational safety and health administration (osha) requires that all health care workers be fit tested prior to respirator use in health care settings. fit testing is a relatively time-consuming process that requires staff and supplies, including various sizes and styles of respirators. annual fit testing is part of most hospitals' respiratory protection program and is often spread out throughout the year. the novel h n pandemic posed unique challenges for hospitals because of the need to fit test a large number of staff in a short period of time and the desire to conserve respirators. this worked well in some facilities, but other hospitals had more difficulty. as focus group participants explained: ''our emergency operations plan includes just-intime fit testing for [events like pandemics], and it went very smoothly. we tested almost people in about days. and it worked beautifully for us.'' ''we had our staff fit tested prior to [the h n outbreak] ever occurring. but we ran out of certain models that we had a lot of our staff fit tested for. and so we did still have n s, but we had to do some pretty frantic fit testing to fit people for alternate models.'' ''we actually stopped fit testing respirators [during the event] mainly because we didn't want to waste [the respirators]. every time you fit test somebody, you can use up to respirators, and we just didn't want to waste them.'' to avoid the need or reduce the number of employees who needed to be fit tested, some hospitals decided to have health care workers use powered air purifying respirators (papr) instead of n s as respiratory protection when caring for novel h n patients. as one participant explained: ''we used paprs in our facility. we had made that choice about years ago to do that, and that was probably one of the best decisions we made, is to go with paprs. some of my colleagues have been doing just-in-time fit testing. some of them had to do like people in week.'' at the start of the novel h n outbreak, many clinicians used the rapid test for seasonal influenza a and b in an attempt to quickly identify potentially infected novel h n individuals. however, it was soon discovered that the sensitivity of these rapid tests was very low for novel h n , leading to numerous false negatives. confirmatory testing consists of reverse-transcription polymerase chain reaction (rt-pcr) or viral culture; this testing is usually obtained via state health department reference laboratories. the focus group participants stated that many patients with negative rapid tests were later found to be positive for novel h n on rt-pcr or viral culture. the focus group participants identified various infection prevention issues resulting from the lack of a reliable rapid test for novel h n . one issue identified by the focus group members was the lack of consistency regarding the use of the rapid test for surveillance or treatment purposes. as one participant noted, ''we don't clearly define what we want the testing to provide for us. it's either a surveillance and/or a treatment modality.'' many focus group participants emphasized that testing only lasted for a short period of time and had very specific rules regarding who could be tested. this caused a lot of confusion among the general public and made surveillance and control measures much more difficult for the focus group members. as one participant explained it, ''that's one of the reasons the decision was made to stop [testing] because we knew [novel h n ] was out there. so what's the point? we're not going to treat [the infected individuals]. we're not going to do anything unless they're admitted, critically ill, etc.'' another focus group member relayed her experience with the public's perception about rapid testing: ''we were pretty rigid about following the case definition.. that zeroed in on high-risk, hospitalized comorbidity patients. we had an year old who went to see a pediatrician, and the pediatrician wanted the child tested, but the child didn't fit into one of the groups in the algorithm. and so they sent the child's specimen to an outside lab.. and they were able to identify that the child did have h n swine origin influenza a. and then the media [said], Ôyou don't care about this year-old child!Õ because you refused to test the child.'' there were also challenges obtaining confirmatory testing that was coordinated through state public health reference laboratories. many focus group participants described long waits for test results that made implementing control measures more difficult. as one participant stated, ''[reference laboratories] back log initially was just horrid.'' focus group members stated that they often had to wait weeks for test results, making contact tracing, surveillance, and control strategies nearly impossible. two participants described their experience as follows: ' ' screening, triage, and visitor control focus group participants described varying degrees of success with their facility's attempts to screen and triage staff, patients, and visitors. some focus group participants stated that screening was successful. as one participant described: ''[everyone] had to be screened, and, if they didn't pass the first screening, then they were sent over to the next station to do a quick temperature check. if they were employees, they were sent to employee health and most of the time, sent home. so it really worked; it was really a cohesive effort on our part.'' other focus group participants described difficulties with the screening process, especially related to the large number of visitors and numerous entrances to facilities. as one participant stated, ''i'm envious of the people who were able to screen visitors. we're not that large-we only have beds-but the visitor traffic [was overwhelming]. we have about entrances to the hospital.'' another participant agreed and added, ''from our parking deck, [visitors] can get into the hospital at or different levels.'' solutions recommended by the focus group members to help control and screen visitors included locking the main entrances so people can exit but not enter without being screened and having security professionals or volunteers conduct visitor screening. phone triage was another strategy emphasized by numerous focus group participants as being an essential component of pandemic planning because it reduces unnecessary traffic in the hospital emergency department for patient screening. two participants described their experience with phone triage as follows: ''[phone triage is] a resource for people to call in and talk to a live person about whether or not they should come in to our emergency department. we had a resource line, but not / , and there were people that just needed to [hear from a medical professional] to say Ôno, your kid is not sick enough. stay home and watch his temper-atureÕ and to reassure them so they didn't end up in our emergency department.'' ''[phone triage is] something that pediatric facilities generally do pretty well because we don't want parents flooding in all the time every time there's something going around. i think we do that really well.. [we] have off-hours phone triage available for support, and i think that that's a lesson that perhaps everybody can learn, is how useful that is. and it will save you money, and parents and families would love the support.'' one focus group participant also described the need to have indoor or covered areas to triage individuals. the participant described her experience: ''we were going to triage outside, and we're in a very warm climate, and so mosquitoes [could have been a problem]. fortunately, rain hadn't started yet, but it could have been a really bad disaster. so, part of our next planning phase is to find ways to bring [triage] indoors, or at least to bring it under shelter, because had it been raining during those weeks, it could have been a disaster; and, as it was, we had to do a lot of mosquito prevention.'' focus group participants discussed many educational topics on which ips should be trained. the most important educational topics identified by the focus group participants according to their ranking using the nominal group method included the following: ( ) isolation precautions and ppe recommendations, ( ) coordination with community response agencies, ( ) surge management, and ( ) the ip's role in emergency management. a full list of educational topics identified by the focus group participants are outlined in table . the focus group participants emphasized that the written educational materials need to be much shorter than what was offered in spring . as one participant noted, ''the information sheets [created by cdc] were too long. the first one was pages.'' focus group participants stated that educational materials need to be evidence-based, short ( - pages at most), and written in ''bullet points,'' or else health care providers will stop reading. the focus group discussions provided several important findings. information provided by the focus group participants highlights a number of educational/reference materials that are needed for the current novel h n event and future pandemics and describes the best format for these items. whenever possible, reference materials need to be translated into multiple languages so that all health care clientele can access this information. pandemic planning educational and reference materials identified by the focus group participants need to be generated and made available as soon as possible, given the potential resurgence of novel h n or concomitant outbreaks of seasonal influenza and novel h n in fall/winter . the novel h n pandemic illustrates the need for ips to find new ways of controlling surge and preventing secondary health care-associated transmission during an infectious disease outbreak. historically, ips have been concerned primarily about hospitals and acute care settings. the novel h n pandemic demonstrates the need to implement infection prevention strategies in all health care settings, including ambulatory care centers, physician offices, home health, and long-term care. infection prevention emergency management guidance for these nonacute care settings has been lacking. it is essential that infection prevention recommendations be developed for these settings to help control disease spread and ultimately prevent and control surge in hospitals. one essential component of these recommendations is the identified need for a stronger focus on occupational health. staff surge capacity is necessary to maintain functionality of health care facilities during pandemics, and healthy staff contributes strongly to sustaining this capacity. occupational health issues that need to be addressed include having policies and procedures for screening/ triaging staff, furloughing employees, and better sick leave practices to prevent ill health care providers from coming to work sick during pandemics. changing standards and recommendations are to be expected during outbreaks of emerging infectious diseases and pandemics as more is learned about the causative agent and new anti-infective therapy and/or control measures are discovered. these changing practices must be communicated carefully to prevent mistrust among the staff. failure to do so can result in poor adherence to infection prevention practices because of confusion among health care professionals. this could lead to secondary transmission in health care facilities and occupational exposures. health care professionals should be told that outbreaks of emerging infectious diseases, such as novel h n , are expected to bring rapidly changing case definitions, surveillance methodologies, and control measures. these changes should be evidence based and communicated to staff as clearly and concisely as possible to prevent confusion and mistrust. researchers need to continue to examine disease transmission and appropriate isolation and ppe for novel h n . conflicting guidance on infection prevention for novel h n has led to a lot of confusion among health care professionals and frustration for ips. one third of the focus group participants reported that they changed isolation precautions and protective measures midway through response to the novel h n outbreak. focus group participants also reported that the potentially unnecessary use of n respirators caused much confusion for staff and resulted in a shortage of supplies in their facilities, according to those who participated in the focus groups. these focus groups occurred the week before the world health organization officially declared the novel h n outbreak a pandemic, yet hospitals were already running out of supplies-even after regional and national stockpiles were deployed. one quarter of all focus group participants' facilities ran out of respiratory protection supplies during the spring of , and almost one quarter needed to implement a reuse policy for respirators to conserve limited resources. hospitals need better plans for obtaining or reusing necessary equipment and supplies during patient surges. overall, the focus group method of inquiry served as a valuable tool in eliciting rich, detailed information about ips' opinions of lessons learned from the first part of the novel h n influenza a pandemic. structured surveys with closed-ended responses (opposed to the open-ended questions used in this study) may have revealed different opinions about references materials needed for future pandemics and educational priorities for ips. it is not known whether the ips who chose to participate differed from those who were eligible but chose not to participate. therefore, the information presented here may not be generalizable to all hospitals. this is especially true for the survey questions regarding hospital or agency protocols for worker protection, isolation, and ppe usage during the event; the small sample size needed for focus group methodologies may limit the generalizability of the survey results. ips involvement in preparedness and response to pandemics and other disasters involving a biologic agent is essential. this study identifies lessons learned from the first part of the novel h n influenza a pandemic and highlights gaps in emergency management most in need of being addressed: infection prevention in nonacute care settings, employee health during pandemics, communication, ppe availability and recommendations for use, and maintaining quality of care during times of rapidly changing and conflicting recommendations. ips must continue to address gaps in pandemic planning. one way to accomplish this is through the creation and distribution of ip-specific educational tools and reference materials for emergency management. the topics identified by ips who experienced the first wave of the novel h n influenza a pandemic should be used as the basis for these new educational initiatives. world health organization. current who phase of pandemic alert centers for disease control and prevention. novel h n flu situation update centers for disease control andprevention. novel h n flu situation update evaluation research team. centers for disease control and prevention. gaining consensus among stakeholders through the nominal group technique focus group fundamentals fit testing procedures (mandatory). . app a use of rapid influenza diagnostic tests for patients with influenza-like illness during the novel h n influenza virus (swine flu) outbreak key: cord- -eham trt authors: lor, aun; thomas, james c.; barrett, drue h.; ortmann, leonard w.; herrera guibert, dionisio j. title: key ethical issues discussed at cdc-sponsored international, regional meetings to explore cultural perspectives and contexts on pandemic influenza preparedness and response date: - - journal: int j health policy manag doi: . /ijhpm. . sha: doc_id: cord_uid: eham trt background: recognizing the importance of having a broad exploration of how cultural perspectives may shape thinking about ethical considerations, the centers for disease control and prevention (cdc) funded four regional meetings in africa, asia, latin america, and the eastern mediterranean to explore these perspectives relevant to pandemic influenza preparedness and response. the meetings were attended by health professionals, scientists, academics, ethicists, religious leaders, and other community members representing countries in these regions. methods: we reviewed the meeting reports, notes and stories and mapped outcomes to the key ethical challenges for pandemic influenza response described in the world health organization’s (who’s) guidance, ethical considerations in developing a public health response to pandemic influenza: transparency and public engagement, allocation of resources, social distancing, obligations to and of healthcare workers, and international collaboration. results: the important role of transparency and public engagement were widely accepted among participants. however, there was general agreement that no "one size fits all" approach to allocating resources can address the variety of economic, cultural and other contextual factors that must be taken into account. the importance of social distancing as a tool to limit disease transmission was also recognized, but the difficulties associated with this measure were acknowledged. there was agreement that healthcare workers often have competing obligations and that government has a responsibility to assist healthcare workers in doing their job by providing appropriate training and equipment. finally, there was agreement about the importance of international collaboration for combating global health threats. conclusion: although some cultural differences in the values that frame pandemic preparedness and response efforts were observed, participants generally agreed on the key ethical principles discussed in the who’s guidance. most significantly the input gathered from these regional meetings pointed to the important role that procedural ethics can play in bringing people and countries together to respond to the shared health threat posed by a pandemic influenza despite the existence of cultural differences. before the ebola outbreak in west africa captured the world's attention, one of the most feared yet widely anticipated events in public health was a pandemic of highly pathogenic influenza. in the th century, there were three notable influenza pandemics -the "spanish flu" (h n virus) in and , which resulted in approximately million deaths worldwide ; the "asian flu" (h n virus) in [ ] [ ] , which resulted in - million deaths worldwide , ; and the "hong kong flu" (h n virus) in , which resulted in million deaths worldwide. , in the late s and in early s, concern focused on the spread of avian influenza virus h n to humans. the first cases of human infection with h n were reported in in hong kong ( cases of which were fatal). [ ] [ ] [ ] [ ] fears about h n were heightened in when the virus was found to be responsible for serious disease and death in humans. nearly human cases of h n have been reported from countries since through october . other outbreaks led to questions about preparedness. the outbreak of severe acute respiratory syndrome (sars) in contributed to growing concern about the world's ability to prepare for and respond to a worldwide epidemic. sars, first reported in asia in february , is a viral respiratory illness caused by a coronavirus. the illness spread rapidly to more than two dozen countries in north america, south america, europe, and asia before the sars global outbreak was contained in . the reemergence of the h n virus during the - influenza season, the emergence of the middle east respiratory syndrome coronavirus (mers-cov) in , and the cases of severe illness in humans from a new avian influenza a (h n ) virus in heightened concerns about the need to be prepared for pandemics. an influenza pandemic results in a sudden surge of people with acute health needs, placing extra burden on health resources already overstretched in many places. the severity and suddenness of these burdens can create ethical tensions along a number of fronts. one such tension to which policymakers already have given considerable attention is the ethical allocation of scarce supplies of antivirals, vaccines, respirators, and personal protective equipment. [ ] [ ] [ ] [ ] healthcare workers will encounter challenging ethical dilemmas involving their professional duties to patients and their strong competing obligation to protect and care for themselves and their family. the employers of these workers will have obligations to minimize risks to their employees, while countries will have obligations relating to international collaboration that can compete with domestic priorities. at the request of member states, the world health organization (who) convened an international group in to identify common ethical concerns in preparing for and responding to a pandemic influenza and to provide preliminary guidance on how to address these issues. this resulted in the release of ethical considerations in developing a public health response to pandemic influenza. in addition to discussing general ethical considerations (eg, balancing rights, interests and values, transparency and community engagement), the who ethics guidance discussed issues relating to priority setting and equitable access to therapeutic and prophylactic measures; use of isolation, quarantine, border control and social distancing measures; and the role and obligations of and to healthcare workers. an overriding theme for the who guidance was the need for international cooperation and the importance of taking into account the contextual and cultural considerations of particular countries or regions. the who document notes that "ethical considerations will be shaped by the local context and cultural values. " cdc also developed ethical guidance relating to pandemic influenza. , this guidance focused on ethical issues relating to allocation of scarce resources and use of public health interventions which may limit individual liberties. in addition to the who and cdc documents, there is considerable literature devoted to ethical considerations in pandemic influenza preparedness and response. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] however, whereas most of this literature assumes a liberal democratic perspective in considering ethics and values, many countries that would partner in a global pandemic response are more hierarchically structured. in hierarchical societies, citizens tend to implicitly expect and trust decisions from their leaders. notwithstanding that liberal democratic societies emphasize individual autonomy, collective decision-making and the interrelatedness and interdependence of community members are fundamental to every human society. because in hierarchic societies these factors have greater visibility, in such societies the success of public health interventions will depend on engaging recognized tribal, community or religious leaders in decision-making. recognizing the importance of having a broader exploration of how cultural perspectives may shape thinking about ethical considerations, cdc sponsored meetings in africa, asia, latin america, and the eastern mediterranean to explore various cultural perspectives relevant to pandemic influenza preparedness and response. the meeting in africa was held in collaboration with who and the african field epidemiology network (afenet) in kampala, uganda on august - , ) in sharm el sheikh, egypt on december - , . the key objectives for all four meetings were to: ( ) identify culturalspecific ethical challenges in pandemic influenza detection and control, ( ) explore approaches for addressing these ethical challenges, including how to best integrate ethical considerations into country/regional pandemic influenza preparedness and response guidelines and implementation strategies, and ( ) begin establishing a social network to foster continued discussion about ethical issues in the practice of public health. the meetings were attended by government health officials and policy-makers, public health practitioners, scientists from academic and research institutions, epidemiologists, philosophers, ethicists, religious leaders, and representatives of international aid and health organizations. the african meeting was attended by people, including representatives from african countries (nigeria, south sudan, south africa, zimbabwe, togo, mali, cameroun, burkina faso, tanzania, kenya, egypt, and uganda). the asian meeting was attended by people, including representatives from countries (cambodia, china, india, indonesia, laos, myanmar, philippines, thailand, and vietnam). the latin america meeting was attended by people, including representatives from latin american countries (argentina, brazil, columbia, costa rica, dominican republic, el salvador, guatemala, honduras, mexico, panama, and peru). the eastern mediterranean meeting was attended by people, including representatives from countries (egypt, afghanistan, pakistan, sudan, yemen, iraq, jordan, and morocco). for this paper, we reviewed the reports, notes, and stories resulted from the four regional meetings. we mapped outcomes from the meetings to five key ethical challenges identified in the who guidance: transparency and public engagement, allocation of resources, social distancing, obligations to and of healthcare workers, and international collaboration. we report here the objectives, processes, and ethical issues discussed at these meetings as they relate to the who key ethical challenges. in addition, each of the coauthors of this paper attended at least one of the four meetings. description of processes used in organizing the regional meetings to ensure that everyone had the basic knowledge needed to engage in the discussions, all meetings began with overviews of influenza biology, epidemiology, and history, including lessons learned from past influenza pandemics and the sars pandemic. the focus of the meetings was on planning for a highly pathogenic h n influenza; however, the h n influenza was running its course during the asian meeting and discussion of that epidemic entered the conversation. information was presented on the who and cdc ethics guidance documents as a starting point for discussing how ethical considerations may differ between countries. in addition, there were presentations on the basic principles of public health ethics and how it differs from more traditional clinical and research ethics approaches, and discussion of ethical challenges that are likely to arise in response to planning for and responding to pandemic influenza. the latin america meeting also included a session on human rights. out of respect for local partners, somewhat different processes were used in the four meetings to generate discussion of ethical issues. in the african meeting, participants met in small groups to discuss pre-developed case studies addressing the topics of non-pharmaceutical interventions, obligations of healthcare workers, and equitable access to treatment and prophylaxis. participants were asked to consider the case in light of specific challenges they may face in their countries. in the asian meeting, participants met in small groups and were asked to develop their own short narratives about the ethical issues they thought would be important in a pandemic influenza and how the values and cultural consideration in their counties would impact approaches for addressing these ethical issues. participants wrote short narratives answering the following prompt: prior to this meeting, a close friend explains that he does not understand why ethical issues are important in a pandemic response. what experience, either yours or someone else's would you share to illustrate the significance and importance of public health ethics in a pandemic response? during the latin america meeting, participants, grouped by country, were asked to identify key points for integrating ethics into emergency plans. during the eastern mediterranean meeting, participants were asked to share stories about ethical issues encountered during public health responses and to discuss how these issues were addressed in their response plans. organizers took minutes and notes of meeting proceedings and developed summary reports for all meetings. unpublished reports are available at request. for each of the organizing topics below, we first present some common themes discussed at the four meetings followed by more specific perspectives from each of the meetings in chronological order of when the meetings were held, beginning with african perspectives (august ), followed by asian perspectives (march ), latin american perspectives (july ), and eastern mediterranean (december ) perspectives. the who framework was used as a starting point for discussion at all meetings, but due to the characteristics, nature of events, and interests of local partners, discussions were not always focused on the same issues. discussions at the two latter meetings were by-andlarge affirming of the perspectives discussed at the two former meetings. based on the meeting reports, fewer details related to the ethical challenges emerged from the latin america and eastern mediterranean meetings than are for the africa and asian meetings. transparency, in which relevant information is made freely available, and public engagement were seen by participants at all meetings as factors critical to an effective response during a pandemic influenza emergency. many related issues were discussed, including low literacy level, poverty, and trust of and/or deference to health authorities. some cultural variations were expressed; for example, that certain societies more readily accept autocratic directives for disease control. participants at all meetings affirmed that their cultures do not tolerate corruption and indicated that a lack of transparency raises suspicions of corrupt dealings. government authorities and leaders are expected to be open and consult the community in making important decisions, including public health emergency decisions, affecting their people. factors that complicate mass communication that were discussed at all meetings include low levels of literacy, the inaccessibility of media such as television, newspapers, and the internet because of poverty; and the unavailability of the internet and cell phone towers in some rural areas. although the detail and depth of discussions regionally varied and some cultural variation was evident, transparency in decision-making was in general decisively affirmed. at the african meeting, in contrast to the general perception that "big men" and individuals with centralized power make all of the decisions, participants agreed that traditional cultures expect leaders to seek input from those they lead, through elder councils and similar institutions. participants noted that public health leaders include traditional healers who serve as both recipients of and conduits for information. because many africans will seek care from traditional healers during a pandemic, these health providers must also be informed of how to protect themselves from infection, and how to guard against spreading the infection. in addition, a wide variety of local and international non-governmental organizations (ngos), often funded by high-income countries, are active in resource poor countries in africa seeking to meet the populations' most basic needs. thus, it is important that both traditional healers and ngos be engaged in the decisionmaking process. the participants at the asian meeting varied widely in their views and practices relating to informing and engaging the public. for example, when sars broke out in one asian country, the government issued mandatory public health measures and expected public compliance. due to the culture of deference to authority, nearly all communities in this country instantly adopted the measures (eg, quarantine, isolation, and social distancing). however, not all participants reported such deference to authority. this was reflected in a story from another asian country about a boycott of a government polio immunization campaign by a minority community due to suspicions about the government's motives. others reported that when the central government was perceived as misgoverned or weak, responsibilities for informing the public about health threats and providing leadership during emergencies fell to local leaders. participants at the latin american meeting stressed that community participation and cooperation will be crucial during a pandemic influenza response, particularly for migrants or minorities who are already stigmatized. latin american participants also pointed to the importance of the media and health authorities in communicating health information and avoiding panic, as well as to convey factual information about availability and access to therapeutics. some participants were concerned about the wide disparity in resources within and between countries, which make transparency even more important. participants at the eastern mediterranean meeting emphasized the need for inclusion, accountability, and transparency in public health policies, but also noted the reluctance among countries to collaborate because of political differences and disparity in wealth and resources. participants discussed the need to establish a clear understanding of who will make what decisions during an emergency, how guidelines will be established, and the importance of considering multiple perspectives, including perspectives from individuals most at risk. allocation of scarce resources economic, demographic, geographical, and population vulnerability factors were common challenges identified as affecting resource allocation decisions. these challenges were shared in all regions where the meetings occurred. participants agreed that because of the cultural and regional variations, a "one size fits all" approach to any planning and response activity is unlikely to be optimal and should be questioned and challenged. however, although differences were acknowledged, there were also shared understanding and general agreement on the importance of the ethical values discussed at the meetings. participants felt that planning and response should take into account contextual variations and cultural differences. additionally, participants discussed the issue of resource allocation within the framework of transparency, especially when preferential treatment is given to the most powerful community members as opposed to the most vulnerable. the african meeting participants affirmed the importance of providing resources to the young, but noted important differences in perspectives among countries. many african societies give higher status to the elderly than to other age groups. with a life expectancy for some african countries in the s and even s, the proportion of the population composed of young children is much higher than in other countries. thus, in african countries, a preference of allocating scarce resources to children would leave little resources for other segments of the population. generally, african countries are much more rural than are countries of other continents, making access to villages difficult, whether by road, telephone, or internet. although meeting attendees did not feel that rural or urban habitation should be a criterion for allocation of resources, they anticipated that logistical challenges would make it so. these concerns are dwarfed, however, by the likelihood that resources such as antivirals and vaccine will be far scarcer in african countries than elsewhere because of the continent's dual challenge of weak economies coupled with the number of other endemic health challenges, such as malaria and hiv/ aids. with few resources at hand, the ethical imperative to respond to pandemic influenza may fall below that of addressing hyperendemic fatal diseases. each of the countries represented in the asian meeting had a pandemic flu preparedness plan that addressed allocation issues and maintained a national stockpile of antiviral drugs. in most cases, biological vulnerability determined priority; thus, the very young or very old, pregnant women, and immunecompromised individuals tended to be prioritized to receive antiviral drugs. however, as asian cultures exhibit more hierarchy than those in the west, more honor is accorded to the elderly, senior staff, royalty, and public service personnel in asian cultures. in addition, it is expected that relatives and friends of the powerful will be unofficially prioritized to receive limited resources, without that being considered unethical. indeed, in many asian contexts, such prioritization is viewed as a social obligation (eg, a health worker would consider offering antivirals from the limited supply to a senior official before offering the resources to a person in one of the official priority groups). nevertheless, participants expressed disapproval of officials who abuse their power and demand or extort limited resources for themselves. one participant described a shortage of n face masks (masks that can filter at least % of particles from the air) during the sars epidemic. although some people were willing to pay twice the regular price for a n mask, yielding to this demand would in effect favor protection for the rich over the poor. the participants felt the government had a duty to enforce price controls in order to ensure an adequate supply. as an example of enforcing price controls, one government instituted licensing for antiretroviral distribution to put a ceiling on the costs of the medications. some of the asian perspectives on ethical distribution differed by religion. an appeal to buddhist beliefs stated a priority for those who are most severely ill, and the young making sacrifices for their elders. a priority for women and children was expressed with reference to catholic values. when a choice must be made between a mother and her child, participants at the asian meeting felt that catholic values would typically give preference to the mother. some asian nations include island archipelagoes. it will be difficult for populations living on minor remote islands to access medical services and resources during a pandemic. the participants questioned whether their country plans address the challenges that certain geographical conditions may place on the equitable distribution of resources. many participants of the latin american meeting thought that individual rights were paramount and that during a pandemic a clear communication plan that includes community input into the process for drug allocation would help avoid panic. they emphasized the importance of including all sectors of society, including the private sectors, migrants, and minorities in public health decision-making process. issues such as discrimination and stigmatization of certain sectors of the population must be addressed before an emergency situation arises. meeting participants stressed that emergency plans should take into account the diversity of population, must be transparent, and favor equal distribution of resources. at the eastern mediterranean meeting, participants discussed the need to evaluate "what is good for you versus what is good for others. " this included discussing ethical challenges associated with distribution of scarce resources. questions that were explored included: which group of people should be vaccinated first? who will make decisions about distribution? one theme that was identified from this discussion was the importance of prioritizing healthcare workers for access to limited resources, including medical and psychological care and other social benefits, should they become sick during an emergency. the use of social distancing to limit transmission was widely accepted as an important tool in a pandemic influenza response, but participants warned of the many factors and challenges that complicate this traditional public health measure. these include socio-economic factors (eg, densely populated settings), and cultural factors (eg, family duty, funeral rituals). participants in the african meeting agreed with the social distancing principles described in the who document, including making the measures voluntary to the greatest extent possible; ensuring "safe, habitable, and humane conditions of confinement including the provision of basic necessities (food, water, clothing, medical care, etc)"; and employment protection for workers who comply with social distancing measures against the wishes of their employers. participants stressed that isolation and quarantine measures will be more difficult to enforce in rural compared to urban areas in africa due to the isolated geography of some rural areas and the lack of healthcare workers and security officials. however, participants noted that these public health measures have been successfully employed in rural areas in prior epidemics in africa. densely populated urban slums were also noted to present a challenge to social distancing. in a typical slum dwelling, people occupy all available sleeping space at night in small and poorly ventilated homes. there is no separate space available for isolation or quarantine. the same applies in some refugee camps. in such densely populated settings, the lack of freedom of movement may lead to near-certainty of transmission. neighboring communities will be tempted to protect themselves by fencing off the slums or forcibly preventing the exit of slum residents. there was also concern among the participants that some african countries would rely heavily on military personnel to impose order, potentially with unnecessary force. participants in the asian meeting also noted challenges associated with the use of social distancing measures. duty to family is a major theme of confucian philosophy. in some asian countries, it is a tradition for friends and relatives to visit and even stay with a hospitalized person. in many instances, exhortations to family and friends about the serious nature of isolation are no match for the force of tradition: some find a way in and out of the isolation wards. due to the lack of resources, isolation wards do not have security guards, and nursing staff are not able to add policing to their already heavy workload. a common concern reported by participants at the asian meeting was the risk of stigmatization of patients and family members who were placed in isolation and quarantine. one of the participants reported that during the sars outbreak, an entire village was stigmatized because it was home to one of the cases. anybody known to have come from the village was avoided by others. workers from the village were not admitted to their place of employment outside the village. similarly, students were kept out of their schools. when the village was eventually quarantined, people feared delivering food and supplies. the stigma remained long after the epidemic subsided and the quarantine was lifted. high rates of poverty also pose a challenge for use of social distancing measures. it is difficult for patients to remain in isolation wards or for potentially exposed individuals to remain quarantined for long period of time unless compensation can be offered for lost wages. participants at the latin american and eastern mediterranean meetings reflected on the long history of human rights abuses in their countries. this made them more likely to view use of social distancing measures as something that should be considered with great caution. some even viewed these measures as human rights violations. obligations to and of healthcare workers healthcare workers have multiple obligations, including obligations to their patients, to their employers, to their governments, to themselves, and to their families. participants at all meetings understood that healthcare workers cannot completely sacrifice their and their family members' health and well-being as they fulfill their public health duties during an emergency response. participants at the african meeting felt that healthcare workers have the right to stop working if they feel they are not wellprotected. factors discussed included the challenges related to the displacement of health workers during post-election conflict, traditional or cultural practices that may increase the risk of disease spread (eg, hugging or handshaking), and conflicts between senior officials and frontline healthcare workers regarding access to resources. they felt that frontline health workers should have first priority. a complicating factor in many african countries is the presence of large numbers of health-care-related ngos from a variety of countries. what obligations would they have in a pandemic? if the workers or the organizations were to leave the country to attend to the needs of their home country or their families, the african country could lose a sizable proportion of its health workforce. and yet host governments have little authority to demand their assistance. socio-economic factors were predominant in stories told by participants at the asian meeting. for example, during sars outbreak, some private hospitals in one country were only admitting patients who could pay, while some suspected patients did not go to hospitals because they could not pay the inpatient care that could exceed $ per day in a country where per capita annual income is less than $ . some countries reported lack of personal protective equipment, such as face masks, for healthcare workers; or differences in the degree of protection offered according to position (eg, physicians offered more protection than nurses). participants reported that some healthcare workers refused to treat suspected cases, because either they did not have protective equipment and/ or because they were concerned for their own safety and the safety of their loved ones to whom they would return after work. the participants agreed that healthcare facilities and governments had an ethical obligation to adequately and equitably provide personal protective equipment to their employees. in addition, participants felt that education of the employees about transmission control and, in some instances, additional incentives such as hazard pay, can help overcome the hesitancy of healthcare workers to remain on duty during a pandemic surge in cases. participants at the latin american and eastern mediterranean meetings also discussed the roles of healthcare workers during influenza pandemic. participants at both meetings recognized the important responsibilities healthcare workers have to treat patients regardless of the risk to themselves, but also noted that governments have responsibilities to protect healthcare workers. some participants believed that healthcare workers have the right to refuse treatment to patients if the provider fears exposing their own family and that society has an obligation to compensate their families if they die while treating patients. other participants felt that doctors do not have the right to refuse treatment because of their oaths and duties as physicians. international collaboration international collaboration is complicated by many factors, including disparities in resources, political differences, ethnic tension, and distrust. participants, however, agreed that during a pandemic, collaboration is critical, because diseases respect no boundary. participants pointed out that no country, developed or undeveloped, has eliminated poverty and the underlying causes of ill-health, such as lower literacy among the poor and less knowledge about disease prevention. the prevalence of poverty affects not only individuals, but institutions and systems. because of the interdependence of nations, participants thought that it is in the best interest of resource rich countries to help build the capacity of poorer countries to conduct surveillance and disease control. participants in the african meeting stressed that the ability of a developing country to conduct thorough and accurate surveillance depends in large part on the assistance of developed countries in building and maintaining basic public health infrastructure well before a pandemic occurs. moreover, by its very nature, surveillance is an ongoing process, not one that can be initiated in the face of an emergency response and then terminated when things return to normal. in emergencies, international scientists may temporarily fill some personnel gaps. participants observed, however, that some international scientists providing technical assistance during an emergency seem more interested in research than in helping to control the disease outbreak. in some cases, they even diverted resources, such as healthcare workers, that could have been used for disease control. lack of wellequipped laboratories in many african countries has resulted in the transfer of human biological specimens to distant laboratories, sometimes delaying diagnosis and intervention. some surveillance resources are provided by donor nations for specific purposes such as measles eradication. strict accounting rules may prevent the shift of those resources to other purposes, even in the face of a major global threat. the asian meeting participants also expressed concern about specimen sharing. during outbreaks of sars and h n influenza, for example, china shared its specimens with countries around the world for research and vaccine development. during the outbreak of h n in , who noted that countries shared specimens. the asian participants noted that collaboration and communication about disease transmission requires a transparency that can be at odds with the cultural value of 'protecting honor' and 'avoiding being shamed' that is common in asia and elsewhere. reporting an outbreak to other countries can be perceived as admitting inadequate disease control and asking for help from another country may be viewed as a sign of weakness. this is complicated by often pre-existing disputes between neighboring countries. moreover, while helping others is also an important asian cultural value, offering help when a country has not asked for it may be regarded as meddling with the internal affairs of that country. moreover, two asian countries who conducted a joint outbreak investigation exercise observed that multilateral coordination can be time-consuming in ways that hinder a speedy and effective response. participants at the latin american meeting believed that it is important to clarify and disseminate guidelines for pandemic preparation and response, including those produced by who. dissemination of pertinent information and guidelines between countries was considered as an obligation countries have to one another. some noted that although wide disparity exists among latin american countries, there is a great deal of solidarity, which facilitates cross-border collaboration, such as seen in the collaboration between haiti and the dominican republic during the haiti earthquake and resulting cholera epidemic in . participants at the eastern mediterranean meeting noted that countries are sometimes reluctant to collaborate because of the political and resource differences and other disparities between countries in the region. however, they agreed that plans for responding to an influenza pandemic should be shared among countries so that countries will be familiar with neighboring countries' plans. participants believed that country or even regional plans are too broad and more specific sub-regional plans should be developed and implemented. although the ethical concerns raised by participants from these four distinct regions (africa, asia, latin american, and the eastern mediterranean) describe important issues that can shape responses to an international pandemic, the similarities of the perspectives and the concerns were notable. participants reaffirmed the importance of the five key ethical issues framed by who (ie, transparency and public engagement, allocation of resources, social distancing, obligations to and of healthcare workers, and international collaboration). participant feedback can be summarized as followed: • the procedural values of transparency and inclusiveness are widely accepted and crucial for ethical decisionmaking. • no "one size fits all" approach to allocating resources can address the variety of economic, cultural and other contextual factors that must be taken into account, but engaging with communities can help both to discover these factors and to build support for public health recommendations. • although meeting participants acknowledged the importance of social distancing as a tool to limit disease transmission, they also recognized the difficulties associated with this measure. • healthcare workers often have competing obligations that can compromise their ability to fulfill public health duties during an emergency response. government has a responsibility to assist them in doing their job by providing appropriate training and equipment. • although international collaboration may be difficult, a focus on procedural ethics (ie, procedures that ensure transparency, consistency, inclusiveness, and a fair hearing of concerns in a deliberative format) make collaboration possible in efforts to combat global health threats. the discussions from the meetings offer perspectives on how countries can collaborate in the control of international pandemics while respecting different cultural values. although we initially were concerned that cultural differences could seriously impede international collaborations, we believed that anticipatory awareness of value differences would help prevent them from becoming potential stumbling blocks. given this outlook, the meeting organizers were poised to highlight cultural differences. indeed, the meeting exposed numerous cultural differences; eg, people in asian countries more readily defer decision-making to government officials, elders, or other authority figures. many of the differences that surfaced during the meetings reflected differences in how decisions are reached in the context of a country's political arrangements. moreover, as the discussion of resource allocation illustrated, differences in local contexts and traditions necessarily will play a role in how interventions will be implemented. nevertheless, the similarities in perspectives between countries challenged our initial expectation that cultural differences would seriously impede if not prevent collaboration. attempts to change traditional cultural practices frequently fail or result in unintended consequences. however, addressing procedural ethics according to established international norms can assist with overcoming cultural differences within the context of global disease pandemic, political organization or local context. for example, the complicated ritual washing of bodies became a contentious issue in the - ebola response, because of its role in facilitating the spread of ebola virus. culturally, this practice was considered an essential part of preparing the dead for the after-life. public health and government workers contemplating halting or altering ritual practices require great cultural sensitivity and finesse in presenting alternatives that are perceived as fair and acceptable to a community already suffering from irreplaceable loss of their loved ones. the recent who ethics workgroup on ebola again illustrates the importance of a focus on procedural ethics. the workgroup included, along with ethicists and subject matter experts on ebola, representatives from the three west african countries hit hardest by the ebola virus. in relatively short order, the workgroup came to agreement on prominent ethical issues, such as the use of promising experimental drugs against ebola virus, the need to conduct research on these drugs, and the importance of informed consent even during a public health emergency. their success suggests that, when a fair process is established that includes the voices of those affected by the outbreak, a pandemic involving a deadly disease can bring countries rapidly together around the shared value of health, rather than divide them on the basis of cultural differences. perhaps the consensus regarding the importance of combating a pandemic health threat was to be expected, given that cdc or its partners such as tephinet sponsored and coordinated all four meetings, and, more importantly, the who ethics guidance framed the discussions of ethics topics. perhaps the participants consciously or subconsciously stated what they thought the sponsors wanted to hear. in addition, as many of the participants were public health officials, they brought with them a shared commitment to addressing health concerns. it is possible that the input of these health professionals, more numerous and vocal than other participants, explains the observed continuity around health-related matters. however, these conjectures do not seem compelling. cdc's sponsorship and the framing of discussion around the who's topics did not of themselves preclude major differences from surfacing within any particular topic. it also seems highly unlikely that the majority of differences were to be found outside of those ethics topics discussed at the meeting. the same who framework that oriented the participants to these topics also oriented them to the theme of cultural differences. moreover, the exercises, discussions, and responses were open ended and varied rather than being highly directive. it also seems improbable that participants were merely telling us what we wanted to hear and held back from expressing profound differences when the purpose of the meetings was precisely to explore cultural differences. a simpler and more compelling explanation lies in a crosscultural continuity regarding the importance of combating the health threats that would result from a pandemic event. this continuity should come as no surprise. human rights advocates, for example, deem health so fundamental to human flourishing that they consider it a basic human right. [ ] [ ] [ ] [ ] [ ] the "right of everyone to the enjoyment of the highest attainable standard of physical and mental health. " is encapsulated in article of the international covenant on economic, social, and cultural rights (cescr), a covenant which out of countries have thus far ratified. , similarly, the capability approach maintains that the freedom to achieve well-being is a primary human capability that creates the opportunity for people to realize other capabilities they value. campbell describes health as a liberation or freedom not only from pain or illness, but also as a freedom that allows a person to "create, inhabit a space, to simply live, and share the world around us. " for campbell, the concept of health lies in this freedom. he further believes that the meaning of health reflects personal values and beliefs that are closely linked to the local community and socio-cultural group. health in this view and as a matter of common human understanding is seen as a gateway, if not precondition, for developing other human functions and capabilities. it is a matter, then, not only of ethical theory but also of practical human life that pandemics, which pose existential threats to health, could be expected to elicit similar responses across cultures. there are a number of limitations associated with this manuscript. the manuscript reflects what we found of most interest in the reports, notes, and stories generated from the four regional meetings. it does not provide a complete reporting of the meeting proceedings; rather, it focuses on the parts of the discussion that were related to the key ethical challenges identified in the who ethical framework document. the meetings were meant to initiate an international dialogue about how ethical considerations can be incorporated into pandemic influenza preparedness among members of the field epidemiology training programs, public health officials, policy-makers, scientists, ethicists, religious leaders, and representatives of international aid and health organizations. the meetings were not part of a research study meant to develop new or generalizable knowledge. participants were not recruited in a systematic fashion. cdc relied on local partners to identify and nominate participants to attend the regional meetings. meeting agendas, sessions, and structures were tailored to the local interests and circumstances. although participants were oriented to the who ethics framework at the beginning of each meeting, discussions were not always focused on the same issues. this may explain the lack of consistency in the amount and depth of the discussions on the key ethical challenges identified in the who document. if the analysis and explanations above are sound, then it indicates that cultural differences need not pose a serious challenge for collaboration between countries in addressing an international pandemic. likewise, substantive ethical differences need not pose a serious impediment to pandemic preparedness efforts especially if more attention is paid to procedural ethics, that is, to procedures that ensure transparency, consistency, inclusiveness, and a fair hearing of concerns in a deliberative format. if any lesson is learned from past pandemics, it is that each one informs our response to the next. likewise, the ethical issues raised by past public health emergencies should serve to better prepare ourselves to effectively respond to the next emergency. the same applies to the discussions generated by the regional meetings described in this document. they affirm the notion that, cultural differences notwithstanding, people and countries will come together to combat the health threat a pandemic influenza poses to all, when fair procedures are established that give those affected a seat at the table and a voice. pandemic flu history. department of health and human services (flu.gov) website h n . department of health and human services (flu.gov) website lessons from previous influenza pandemics and from the mexican response to the current influenza pandemic h n . department of health and human services (flu.gov) website influenza epidemics and pandemics avian influenza virus h n : a review of its history and information regarding its potential to cause the next pandemic influenza viruses and the evolution of avian influenza virus h n avian influenza: the next pandemic? disease-a-month h n avian influenza: timeline of major events - january. world health organization website severe acute respiratory syndrome h n virus transmission and outbreaks update: severe respiratory illness associated with middle east respiratory syndrome coronavirus (mers-cov) -worldwide avian influenza a (h n ) virus. centers for disease control and prevention website stockpiling antiviral drugs for pandemic influenza: the key ethical principles. prepared by the ethics subcommittee of the advisory committee to the director ethical considerations for decision-making regarding allocation of mechanical ventilators during a severe influenza pandemic or other public health emergency. prepared by the ventilator document workgroup, ethics subcommittee of the advisory committee to the director identifying prioritization criteria to supplement critical care triage protocols for the allocation of ventilators during a pandemic influenza public engagement on ethical principles in allocating scarce resources during an influenza pandemic ethical considerations in developing a public health response to pandemic influenza. world health organization website ethical guidelines in pandemic influenza ethical guidelines in pandemic influenza: recommendations of the ethics subcommittee of the advisory committee of the director ethics and pandemic preparedness: the importance of cross-jurisdictional and cross-cultural perspectives ethical reasoning in pandemic preparedness plans: southeast asia and the western pacific influenza pandemic preparedness: legal and ethical dimensions kayman h, ablorh-odjidja a. revisiting public health preparedness: incorporating social justice principles into pandemic preparedness planning for influenza joint massachusetts department of public health-harvard altered standards of care working group on pandemics and the duty to care: whose duty? who cares facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics a matrix for ethical decision-making in a pandemic. the oregon tool for emergency preparedness pandemic influenza preparedness: an ethical framework to guide decisionmaking an ethics framework for public health and avian influenza pandemic preparedness why china's sars legacy may give it an edge against ebola pandemic (h n ) -update . world health organization website ethical challenges posed by the ebola virus epidemic in west africa ethical issues related to study design for trials on therapeutics for ebola virus disease. who ethics working group meeting report medicine and public health, ethics and human rights towards the development of a human rights impact assessment for the formulation and evaluation of public health policies the right to health in international human rights law what are health and human rights? what is a human-rights based approach to health and does it matter? health hum rights social and cultural rights status of ratification: international covenant on economic, social and cultural rights health as liberation: medicine, theology, and the quest for justice global health as a field of power relations: a response to recent commentaries ebola: the ethics of thinking ahead we acknowledge the invaluable contributions of the following individuals and organizations in organizing the regional meetings, developing meeting reports and summaries, from which this manuscript was based. we especially appreciate the work of mark white (cdc retired) who conceptualized, designed, collected, and analyzed data, and obtained funding and coordinated the regional meetings with external partners. in no particular order, we also would like to acknowledge the contributions of maria consorcia lim-quizon, david mukanga, fred wabwire-mangen, joseph ochieng, patrick nguku, rebecca babirye, dominic thomas, anant bhan, goldie macdonald, andreas reis (who), afenet, emphnet, safetynet, and tephinet. the findings and conclusions in this paper are those of the authors and do not necessarily represent the official position of the centers for disease control and prevention (cdc), the university of north carolina, chapel hill, nc, usa or tephinet at the task force for global health. all coauthors were involved in reviewing reports, stories, summaries, and notes from the meetings described in the manuscript. funding was provided by the united states agency for international development and cdc to support the four regional meetings described in the manuscript. funding was used for travel-related expenses of all participants, including the co-authors of this paper, to participate in one or more of the meetings. not applicable. this manuscript was based on analysis of reports and documentations generated from four cdc-sponsored regional meetings. the meetings were considered routine public health practice and not research per se. key: cord- - dhtwf authors: chow, cristelle; shahdadpuri, raveen; kai-qian, kam; hwee, chan yoke title: the next pandemic: supporting covid- frontline doctors through film discussion date: - - journal: j med humanit doi: . /s - - - sha: doc_id: cord_uid: dhtwf this paper describes an innovative just-in-time health humanities programme to educate and provide support to covid- frontline doctors-in-training. the programme incorporates small-group screening of the netflix documentary, the next pandemic from the explained series, followed by a one-hour facilitated discussion to explore themes surrounding the current pandemic and its impact on frontline doctors in a tertiary paediatric hospital in singapore. themes derived from the film included preparedness, blame, and the impact on healthcare workers and public, which were further discussed to include concerns regarding current local readiness levels given global connectivity, the need for international cooperation, and the effects of blame such as racism and prejudice. the association with culture; the current impact on healthcare workers, physician-patient relationships, and the public including the role of social media, the government and associated public reactions were also explored. these rich discussions demonstrate the pivotal role health humanities has in times of uncertainty such as an emerging infectious disease outbreak by providing timely pandemic education and supporting reflective learning. the term, "cinemeducation," coined by alexander, hall, and pettice ( , ) , refers to the use of movie clips to educate medical students and residents about the psychosocial aspects of medicine. films, because of their audio-visual nature, can both engage and enthral viewers with emotional and dramatic portrayals of individual struggles and challenging interpersonal relationships. when health conditions, whether physical or psychological, drive or are explored in the film's themes, viewers can gain a deeper appreciation of the illness experience (powley and higson ) . especially for individuals training in the healthcare professions, movies can engage learners in deeper discussion and promote active learning through cognitive and social constructivism. learners embed new knowledge acquired from the film onto pre-existing cognitive structures and construct knowledge through group discussions with other learners, reflecting upon their personal experiences along the way. a systematic review by darbyshire and baker ( ) provides insights into the various areas in which cinema is used in medical education, ranging from hard science topics like biology and virology to soft skills like professionalism and ethics. while movies can be used for the teaching of many aspects of medicine, the use of movies in providing education and support during acute outbreak situations has yet to be described, as the health humanities is often viewed as a component of "peace time" education. the uncertainty of an emerging infectious disease can have significant psychological impact on frontline doctors (tan ; lai et al. ) , and provision of the health humanities during this period could potentially help to provide just-in-time education and address perceptions of safety, threat and risk (rambaldini et al. ) . hence, as the world experiences the current covid- pandemic situation, this study aims to describe the use of a short film and post-film discussion to educate and support frontline doctorsin-training during an acute emerging infectious disease outbreak. this study also aims to broadly describe the discussion themes generated through this just-in-time intervention (table ) . from february onwards, the department of paediatrics in a tertiary women's and children's hospital in singapore assigned rotating groups of house medical staff and paediatric consultants into isolation wards designated for suspect and confirmed covid- paediatric cases. rotations for house medical staff were in two-week blocks including weekends and public holidays, in a twelve-hour shift system. dyads consisting of related paediatric and adult patients were also admitted to these wards. in mid-february , singapore experienced an increasing number of covid- infected cases in the adult healthcare institutions. in our institution, we had admitted a dyad of infected infant and mother in our isolation unit by february (kam et al. ). there was still significant uncertainty about the virus' transmissibility, virulence and potential to cause morbidity and mortality. all house medical staff posted to isolation wards, consisting of freshly graduated house officers, medical officers (in non-training positions), paediatric junior residents, senior residents and resident physicians were invited to the film screening during their shift hours. participation was voluntary, and all participants were informed that a post-film discussion with notetaking by the facilitators would be carried out. facilitators consisted of paediatric faculty from general paediatrics, intensive care and infectious diseases, and some facilitators were teleconferenced into the discussion due to the hospital's enforced modular system. the film was selected based on recommendations by baños and bosch ( ) . two faculty members (cc and rs) reviewed several pandemic-related films of varying durations to assess its suitability and relevance for this study. the decision was made to screen the short documentary from the original netflix explained series entitled, the next pandemic. it was selected due to its timely recent release ( th november ), directness, factuality, short runtime of just over twenty minutes, relevance to the current hospital climate, and feature of severe acute respiratory syndrome (sars) which significantly impacted singapore in (tan ) . the above-mentioned faculty members independently watched the film multiple times to determine its underlying themes, generate educational objectives and questions to be used in the post-film discussion. the educational objectives of the session were: ( ) to know the significant historical pandemics that impact ongoing pandemic preparedness efforts, ( ) to discuss the challenges associated with the current pandemic and ( ) to reflect on the impact of the current pandemic on personal lives, healthcare workers and the general public. three questions were selected for post-film discussion: ( ) how did the film make you feel about the current covid- situation? ( ) how has frontline covid- work impacted your personal lives, your families and your relationships with your patients? ( ) how do you feel about the public's response to the covid- pandemic? the session started with projection of the documentary to a small group of not more than twelve participants. this was followed by a post-film discussion facilitated by faculty members for approximately one hour. facilitators encouraged active participation using the prepared questions although new and more relevant issues emerged during the session. participants and faculty members interactively exchanged their opinions in a nonjudgemental and constructive way, using the film as the initial basis of discussion, then branching out into new discussion areas. during the session, facilitators took notes of the broad themes discussed, including relevant quotes from participants. notes taken by facilitators were thematically analysed by the study authors independently for recurring themes. this was followed by discussion among the authors, and the final themes that were mutually agreed were organized in relation to the pre-determined themes from the film. a total of six similar sessions were conducted between february and march , involving a total of sixty-three participants and six faculty members. of the sixty-three participants, twenty-eight were paediatric senior residents and resident physicians, four were paediatric junior residents, fourteen were non-trainee medical officers, and fifteen were house officers. of the faculty members, three were paediatric infectious disease physicians, two were general paediatricians, and one was a paediatric intensivist. from the film, four issues in particular were depicted as the main themes for group discussion, which included the following: pandemic preparedness, the allocation of blame, the impact on healthcare workers and the impact on the general public. during the film discussion, these were further branched into other areas of discussion by the participants (table ) . participants were asked the question of whether the country, hospital and the public were truly prepared for the pandemic. they reflected upon the film's depiction of sars, and how the authorities in affected countries had "let it pass" until there was a significant number of deaths. they questioned whether we had really learnt from the sars outbreak and expressed helplessness, fear, uncertainty and being overwhelmed by the possibility of an uncontrollable pandemic. these perceptions were more prevalent in the discussions that were held in mid-february when the outbreak had still not peaked. a few residents shared that their fear stemmed from the uncertainty of how lethal the virus was and that preparation, vaccine research, personal protective equipment and border controls may not be sufficient to control the spread of the virus should it be virulent and highly transmissible. in discussions held in late-february and early march, participants expressed less concern about preparedness despite the increasing number of suspect and confirmed cases, as no healthcare workers were infected, and mortality rates were lower than sars. some of them also mentioned their personal preparedness and comfort due to the presence of adequate personal protective equipment and training: "i don't think anyone is really fearful to be in the eid teamthat says a lot about our preparedness." many comparisons were made between sars and covid- with one of the largest differences being the current increased global connectivity of humans because of the affordability and availability of air travel. as singapore is an international transport, trade and travel hub, participants raised concerns about border control methods and whether they were timely or effective in controlling the spread of the virus to the local population. participants recognized the need for international cooperation as one resident shared that the film "makes us feel vulnerable… that we should unite as a human race as this virus transcends gender, race, socioeconomic status…." there were genuine concerns raised that the pandemic preparedness was "not high on the agenda of some governments" and that insufficient funding and resources were being designated for this purpose. participants lamented about the "rise of ultra-nationalism" and self-preservation that would only backfire, as international cooperation and putting aside political and social differences would be key to tackling this pandemic. just as the film subtly apportions blame of the sars epidemic to china (and its wet markets selling live and wild animals), some residents felt that since the start of the covid- outbreak, this blame was manifesting in some countries as racism and prejudice. several participants reflected upon the experiences of loved ones in western countries who were "looked at in a particular way" or treated differently due to being of chinese descent or asian ethnicity. the discussion with regards to the role of traditional wet markets was particularly lively as participants shared that southeast asian countries still have a thriving live wet market scene, which is still very much the cultural norm. it was acknowledged that while live wet markets where "the meat is fresh" are indispensable to many asian communities, the consumption of undomesticated wild animals was not widespread. in china, this practice has been typically associated with higher social status and deep-seated beliefs about the perceived nutrition value of exotic meats. hence, while the general public may be quick to blame others for being the source of the current pandemic, participants reflected that we should also look to our own practices and not be too quick to judge the culture and beliefs of others. while working on the ground, most participants felt safe wearing personal protective equipment (ppe) provided by the hospital. some even mentioned that they did not flinch when they were coughed upon by patients while wearing ppe, and one participant shared: "we're mask fitted, papr (powered air-purifying respirator) trained, and just this feeling that we are well taken care of." however, given initial reports about asymptomatic covid- carriers, some participants were concerned whether they were safe in public areas such as on public transport, as they perceived that they were "more likely to get covid in (trains) rather than from the ward because of the precautions that we take in hospital." participants had differing opinions on disclosure to their families about their hospital work. some participants, especially those who had family members who were also healthcare workers (hcw) , were open about their role in the isolation ward. some of them declared to their loved ones, "i'm dirty… i'm a potential centre for a new cluster" and voluntarily cancelled their social appointments for the period when they worked in the isolation wards. others had decided to "censor information," as they did not want their family members to fear for their well-being. one participant shared that it was "tiring reasoning with every patient then going home and reasoning with family." most family members were supportive of the participants' jobs especially if they were kept informed about the hospital environment and measures taken to minimise transmission to healthcare workers. family members who were also healthcare personnel tended to express more understanding and less paranoia around the fact that the participants were looking after potentially infected or infected patients. however, some participants shared that their family members were still anxious and fearful of contracting the virus from the participants. one frontline staff mentioned that his parents called him "a virus" and kept their distance from him whilst at home, while others provided anecdotes about family members refusing to meet them at social events especially if they were elderly or parents of young children. however, the participants respected the wishes of their loved ones, as one shared, "i can't blame them, they are not wrong, (the elderly person) is more likely to develop a more severe illness." while most participants did not personally experience any overt hcw discrimination, a few shared thoughts about news circulating on social media that made them concerned about this rising trend. it was reported that local nurses in hospital uniforms were chased off public transport and told to leave public eateries due to public fears about contracting the virus from hcw. one participant recounted an episode of a private hire car driver cancelling his ride to the hospital when the participant shared that he was a doctor going to work. in later sessions, participants noted that there were fewer reports of discrimination against hcw and that the public had started to show more support through notes of encouragement, as well as retail, food and beverage promotions and discounts from local businesses. communication with caregivers was deemed the most important task whilst working in the isolation ward. although it was time-consuming, participants felt that caregiver reassurance was key to ensuring adherence to hospital isolation policies and recommended treatment plans. one resident reflected the importance of "having a bit more of a personal touch… reassuring (caregivers) that measures are being taken and the reasons why isolation is as such." anxiety levels of caregivers in the isolation ward were felt to be higher compared to the other general wards, not only due to covid- concerns but also due to the heightened movement restrictions associated with isolation ward admissions. with the need for constant ppe use, there was more physical distance between physicians and patients, inability to see the hcw facial expressions and other non-verbal cues, some challenges in obtaining language interpreters, breathlessness with n masks and fogging of goggles resulting in physicians' discomfort and hence shorter-than-desired consultations. there were also discernible fears of some young children in seeing healthcare staff wearing "spacesuits" especially when obtaining nasopharyngeal specimens for viral testing, although participants tried to reduce patient anxiety through "waving from outside and walking in slowly." participants mostly felt that stepping up to the frontline during a disease outbreak was their duty and one of the reasons for entering the medical profession. in response to individuals who had reservations about working in isolation wards, one participant reflected, "we entered this profession for a reason… in a time of need, how can others refuse to do their duty?" there was heightened appreciation for non-medical healthcare workers, including nurses, who must "stay in the ward and wear the n throughout their shift," porters, lab technicians and ancillary staff such as the porters and cleaners. one participant described watching cleaners wearing n masks who were diligently detaching and disinfecting wheelchair components and was "very impressed by the effort." a significant difference between the time of sars and the current covid- pandemic is the widespread ubiquity and availability of social media (e.g. whatsapp, facebook, instagram). social media was viewed as a "double-edged sword"; on one hand, it provides the public with government-sanctioned information and updates, but on the other hand, it can spread fake news and fuels unwarranted rumours and panic. through social media, personal stories can surface, and different sides of the story can be publishedfor example, one participant shared the heart-warming posts of chinese citizens caring for each other during the wuhan lockdown, which contrasted with undercover videos of chinese hospitals dealing with throngs of patients. overall, social media was still viewed as a positive tool for information dissemination, as long as it was adequately regulated and the public was directed to appropriate and reliable sources of information. participants were collectively concerned about the "uninformed public," as reflected through panic buying and hoarding of daily necessities when the ministry of health escalated to a higher level of disease outbreak response system condition (also known as dorscon) from yellow to orange on th february . controlling public reaction was viewed as a major challenge as participants felt that they could not influence members of the public who refused to abide to government recommendations -"if people do not buy in, (we) cannot force it down." however, participants recognized that as healthcare workers, it was also their responsibility to provide accurate information to the public, whether to concerned family members or doubting caregivers in order to increase public trust in government authorities and reduce irrational and selfish public behaviour. it was also agreed that healthcare workers should be consistent in their messaging and set good examples in following government advisories such as avoiding panic buying and hoarding behaviour and not wearing n masks in public places where it is not clinically necessary (as this would lead to over consumption of limited n supplies). one resident shared that healthcare workers were key to "educating the public to really filter through information that is coming through… and how to react to things when they happen." most participants felt that the government had built up public trust through decisive responses and transparent decision-making processes. they felt that they could trust the authorities to take the necessary steps, whether in border control measures, healthcare advisories or contact tracing efforts in order to protect the local population and reduce the virus' transmission within the community. however, there was some debate on whether the extent of disclosure of positive cases' personal information to the public domain was appropriate, as there was concern about the stigma experienced by positive cases and their family members. one resident shared a personal experience of a close family friend who had recently returned from wuhan, the first epicentre of the virus, and the discrimination that the family experienced despite being tested negative for covid- . participants recognized the fine balance between government transparency and personal data protection, and that "there must be bodies in place to scale down and to decide on what is necessary and what is not," as this would also change as the pandemic evolves. although a handful of participants were initially sceptical about the public's demonstration of appreciation for the hcws, gestures including hand-written notes of gratitude, donation of food items and artworks were generally welcome. some participants also shared that caregivers of both positive and suspect patients had verbally expressed their appreciation to the healthcare team during ward rounds, and admitted children had drawn thank-you cards for nurses and doctors. these simple gestures served as positive motivators for the frontline team. our study demonstrates the feasibility of a short documentary film in generating reflective discussions about an ongoing pandemic and its impact on frontline workers. this health humanities intervention primarily uses the principles of reflection and experiential learning in medical education. reflection, the metacognitive process that creates greater understanding of self and situations to inform future action, has been used in various medical educational approaches (sandars ). in the health humanities, reflection is encapsulated in the studentcentred affective developmental approach, which focuses on the development of self-concept, insight and introspection through the exploration of feelings, attitudes and values (self ) . guided reflection through discussions, rather than reflective writing, was used in this intervention in order to provide participants a safe and supportive environment to make sense of their personal experiences, through non-judgmental questioning and acceptance of different opinions within the group (sandars ). incorporating the principles of the experiential learning cycle, reflection is the second phase after experience, followed by "abstract conceptualisation" (kolb , ) . in this manner, as participants watch the film, they reflect upon how the themes presented through the film relate to their personal experiences of working in the isolation wards during the covid- pandemic. as they share these reflections during the film discussion, they conceptualize new ideas about the ongoing pandemic including its impact on their personal lives, the healthcare system, government authorities and society. being a collaborative group discussion, aspects of social constructivism also contribute to the learning process, as the participants' knowledge is co-constructed through learning from each other's personal experiences and opinions (vygotsky ) . it is also hoped that this intervention provides peer support and encouragement to the participants, improving their mental wellness as they work in the high-risk areas during this pandemic. some of the themes that emerged from the discussion were similar to those reported in other studies that explored the impact of emerging infectious diseases on house staff or medical residents. for example, during the sars outbreak in toronto, medical residents expressed concerns about personal safety and the wellbeing of loved ones, their sense of duty to care, as well as feelings about social isolation (rambaldini et al. ) . while study participants felt confident about ppe and hospital infection control policies, they were also worried about asymptomatically passing on the virus to their loved ones as asymptomatic transmission of sars-cov- was a real possibility, in contrast to the sars virus. the impact of social isolation, whether self-imposed or imposed by others, could have a minimized impact on study participants compared to frontline workers during sars, due to the current widespread use of video chats and social media, which were not available in the early s. during the middle eastern respiratory syndrome (mers) outbreak, medical residents reported concerns about personal and hospital preparedness and fear of disclosure about their frontline work to family members (aldrees et al. ) . although study participants did share that the film questioned the world's preparedness for the next pandemic, when it came to hospital infection control policies, personal protection and ppe training, the majority of study participants felt adequately prepared about working in isolation wards, and there was significant trust in the government's and hospital's management of the worsening outbreak. like medical residents in saudi arabia, some study participants chose to withhold information about their frontline work to family members. as a conservative asian society, it is still common practice to withhold information about personal health and safety risks from the affected patient, so as to not cause unnecessary worry and anxiety among family members, especially those who may be elderly or less educated. the responses of the participants evolved over the course of four weeks with initial fears and anxiety being replaced with more certainty about preparedness. this evolution was likely related to better understanding of the novel coronavirus, the local and global response to the virus, and the extent of control. participants also experienced the "normalization" of working in an outbreak settingas hcws gain acceptance of the crisis and with increasing positive cases, they would experience less apprehension as positive cases start to become the "norm." towards the last few sessions, it appeared that participants accepted that caring for suspect and positive cases would become the mainstay of their clinical work. however, without a heightened sense of vigilance, this "normalization" may result in a lapse in infection control measures. hence, it would be prudent to ensure that frontline workers are constantly provided with appropriate infection control and policy updates to ensure that vigilance and selfprotection are still maintained as the pandemic ensues. an additional pandemic-related theme that has not been previously reported is the apportioning of blame and its subsequent effects of racism and prejudice. in the film, the vivid and somewhat unsettling scenes of chinese wet markets selling live animals during the sars epidemic could have triggered unhappiness over the similarities to which the source of the sars and covid- outbreaks may have originated from. while there was frustration about how governments did not seem to learn from past mistakes, participants also had the opportunity to reflect upon the challenges that governments face in banning practices that are deeply rooted in the society and culture. the discussion enabled participants to also reflect on our own personal biases and not let them cloud our judgement of others and their actions. the doctor's role in the education of the public was also repeatedly discussed. participants saw themselves as representatives beyond the hospital setting as role models for the public to follow government advisories and to protect patient confidentiality. their ability to accept this additional responsibility likely stemmed from their reflection on current public behaviours and their considerable impact. this provided them with an opportunity to generate insight on how they perceived their role as healthcare professionals and allowed them to explore the rationale behind their behaviours and attitudes during this time of international crisis (ginsburg and lingard ) . while participants' responses on the transparency and actions of the government may be quite unique to this study's setting, exploration of this theme in other settings would also be a worthwhile endeavour in hospital pandemic responses, as trust in health and government authorities can have a significant impact on the mental wellbeing of healthcare staff. finally, it was heartening to see that participants were able to reflect upon the importance of appreciating all staff working in healthcare, and while the public may view the true "heroes" as being doctors and nurses, we need to be mindful of the other silent healthcare workers in our midst who are indispensable in combating this pandemic. this study is limited by the number of participants, but despite the small sample size, there was significant heterogeneity in the background and experiences which would have provided significant breadth in discussion. in fact, data saturation was reached by the last session as there were no further new emerging themes. further research is needed to determine if health humanities interventions can further impact participants beyond the sessions, especially in their responses to future pandemics and in their mental wellness as the pandemic continues to rage on locally and throughout the world. as the health humanities is gradually integrated into mainstream medical school and postgraduate medical curricula, just-in-time interventions have a role in providing healthcare professionals with education and support through the current worldwide pandemic. while the focus of this study was on the implementation of a timely film screening and discussion, the themes that emerged from the guided reflections were insightful and can inform future pandemic-preparedness efforts for frontline healthcare staff. medical residents' attitudes and emotions related to middle east respiratory syndrome in saudi arabia cinemeducation: an innovative approach to teaching psychosocial medical care using feature films as a teaching tool in medical schools a systematic review and thematic analysis of cinema in medical education using reflection and rhetoric to understand professional behaviours a well infant with coronavirus disease with high viral load experiential learning: experience as the source of learning and development factors associated with mental health outcomes among health care workers exposed to coronavirus disease the arts in medical education: a practical guide the impact of severe acute respiratory syndrome on medical house staff: a qualitative study the use of reflection in medical education: amee guide no. the educational philosophies behind the medical humanities programs in the united states: an empirical assessment of three different approaches to humanistic medical education psychological impact of the covid- pandemic on health care workers in singapore sars in singapore -key lessons from an epidemic publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- - rbxdimf authors: narushima, miya; kawabata, makie title: “fiercely independent”: experiences of aging in the right place of older women living alone with physical limitations date: - - journal: j aging stud doi: . /j.jaging. . sha: doc_id: cord_uid: rbxdimf this study explores the experience of aging among older canadian women with physical limitations who live by themselves. while aging in place has been a policy priority in rapidly greying canada, a lack of complementary public supports poses challenges for many older adults and their family members. employing a qualitative methodology, and drawing from the notion of aging in the right place, we collected personal narratives of women (aged to ) in two geographic areas in ontario, including residents of regular houses, apartments, condominiums, assisted living and community housing for seniors. through thematic analysis, we identified four overarching themes: ) striving to continue on “at home”, ) living as a “strong independent woman”, ) the help needed to support their “independence”, and ) social activities to maintain self. our findings illustrate how, despite their mobility limitations, older women can change their residential environment and their behavior by deploying the coping strategies and resources they have developed over time. however, we also found that older women are largely silent about their needs, and that experiences varied depending on life histories, health conditions, and the availability of supports in their wider environment (home care, alternative housing options, accessible transportation, opportunities for social and physical activities). we hope these findings will incite further studies and discussion to help make aging in the right place a real choice for anyone who wishes to do so. population aging in canada will keep accelerating over the next decade. the ratio of "senior citizens" (aged years and older) is expected to grow from . % in to . % by (statistics canada, ) . "old-old" canadians in their late s and above are among the fastest growing age group (hudon & milan, ) . like many countries, canada's policy response to this demographic change is the promotion of aging in place, generally understood as being able to remain in familiar homes or communities for as long as possible. the premise is to promote independent living in later life, while shifting care for the older adults from institutions to home and community (dalmer, ; lehning, nicklett, davitt, & wiseman, ) ; a shift long criticized by social gerontologists for being part of the devolution of aging and long-term care policies. policy makers have largely supported this strategy as a cost-effective long-term care alternative. more than anyone, however, it is older adults themselves who are in favor of the idea. aging in place has become common in canada. comparing the and censuses, the ratio of people aged and older living in "collective dwellings" (e.g., assisted living, supportive housing, retirement residences, seniors' apartments, continuum care facilities, and nursing homes) has dropped from . % to . % (garner, tanuseputro, manuel, & sanmartin, ; statistics canada, ) . given the increasing numbers of older canadians, one would expect this number to grow, not decline. the census found only . % of seniors had moved in the past year, a much lower rate than the general population ( . %). this should not, however, be assumed to reflect older adults' satisfaction with their housing. in fact, almost a quarter of seniors reported their housing as "below standard" in terms of either affordability, adequacy, or suitability (federal/provincial/territorial ministers responsible for seniors, ). although health status among older adults is heterogeneous, chronic diseases and physical limitations increase with advancing age. more than three-quarters of canadians aged and older reported having at least one chronic condition, and one quarter reported three or more. one out of four of those aged and over reported a need for support in instrumental activities of daily living (iadl), while one in ten needed support in activities of daily living (adl). like the rest of the world, older women are disproportionately represented in these groups (canadian institute for health information, ) . older women in general are more likely to face challenges since women live longer and are more likely spend their later years with mobility problems and pain (bushnik, tjepkema, & martel, ) and nearly twice as likely to live alone than their male counterparts. the census found . % of seniors lived alone, . % of who were women (tang, galbraith, & truong, ) . in addition, women living alone comprised . % of seniors with "core housing needs" (federal/ provincial/territorial ministers responsible for seniors, ). given these demographic, health, and socio-economic trends, more research on the experience of aging in place among older women, especially those living alone with physical limitations, is needed (gonyea & melekis, ) . from "aging in place" to "aging in the right place" the conceptual development of aging in place began when american environmental gerontologists (lawton & nahemow, ) introduced the "ecological model of aging" to examine the relationship between people and their environments. in this model, an older person's functioning is determined by the "fit" between "personal competences" (e.g., physical, psychological, and social functions) and "environmental characteristics" (e.g., the immediate and wider environments). as changes happen in either or both, older adults can try to adapt their physical and social environments to find a comfort zone by deploying their resources (greenfield, ; lawton & nahemow, ; peace, holland, & kellaher, ; stafford, ) . this theoretical framework helps us to understand aging in place as a dynamic process of personenvironment interactions. wahl, iwarsson, and oswald, and their collogues in germany and sweden have extended this framework to, "maintaining the highest autonomy, well-being, and preservation of one's self and identity as possible, even in the face of severe competence loss" (wahl, iwarsson, & oswald, , p. ). this process is influenced by two concepts: "belonging" and "agency". belonging involves an older person's sense of connection with others and the environment and preserved identities over time. agency refers to sufficient control of their environment to maintain autonomy. belonging grows in importance as people get older, especially when they develop functional impairments (oswald, wahl, schilling, & iwarsson, ; wahl et al., ) . this model reminds us of the benefits of taking a life-course perspective to understand the experience of aging in place. in the same vein, golant ( golant ( , , an american environmental gerontologist, has put forward the notion of aging in the right place. pointing to the unequal capabilities and resources among older adults, golant ( golant ( , criticizes how aging in place has been promoted as a cultural imperative in america, emphasizing an individual's self-reliance in sustaining a healthy active lifestyle. even when older adults have chronic health problems, disabilities, or cognitive deficits, he argues, if they are offered "enabling residential and care opportunities that strengthen their coping skills to achieve their evolving needs and goals", they can still "age successfully" (golant, , p. ). golant thus advocates shifting public discourse, and older adults' thinking, from aging in place to aging in the right place, which includes expanding the various alternative housing options being consideredsuch as group housing, active adult communities, senior apartments, assisted living residences, continuum care, and the like. in this model, regardless of residential type, older adults can achieve "residential normalcy" where they feel comfortable, competent, and in control. older adults may use various coping strategies when their residential normalcy becomes incongruent. moving to alternative housing such as assisted living, active adult communities, and nursing homes can be seen as adaptive responses to aging. golant ( ) also noted that enriched coping strategies are products of the resilience of both older persons and their environments. despite this theoretical development, the public discourse surrounding aging in place in canada seems to have stagnated. for example, in a public guide issued by the federal government, "aging in place" is defined as "having access to services and the health and social supports and services you need to live safely and independently in your home or your community for as long as you wish and are able" (federal/provincial/territorial ministers responsible for seniors, , p. ). the guide also notes that an individual can achieve this goal through early planning in such areas as home, community, transportation, care and support services, social connection, healthy lifestyle, finance, and information. as dalmer ( ) has noted, such neoliberal rhetoric frames aging in place as "a matter of choice" that can be responsibly managed by individuals. given the lack of affordable housing alternatives and the unmet need for long-term home care services for many older canadians, however, this so-called choice is often illusory. as mentioned, according to the census, only . % of canadians aged years and older lived in "collective dwellings," including nursing homes (the most common) and other alternative senior residences such as assisted living and retirement homes. this suggests that moving to alternative housing, as advocated by aging in the right place, is still uncommon in canada. this is partly due to a lack of affordable senior residences. in ontario, the average monthly rent for a standard space for a resident without high-level care needs was $ canadian in (canada mortgage and housing corporation, ). given seniors' average annual income -$ , for men and $ , for women (statistics canada, ) -alternative housing is unaffordable for most older canadians, especially women. as more and more older adults age in place, their homes and communities increasingly become locations for health and social care services (hereafter "home care"). since long-term home care is not universally insured under the canada health act, older adults who don't qualify need to resort to community agencies that often require a co-payment or privately hire help (armstrong, zhu, hirdes, & stolee, ; gilmour, ; government of ontario, ; johnson et al., ; lee, barken, & gonzales, ) . according to the / canadian community health survey, over one-third ( . %) of people with home care needs did not have their needs met, especially among those with home support services for maintenance of daily living (gilmour, ) . the current policy of aging in place needs more complementary public supports to reduce the challenges facing many older adults and their families. it is within this context that we explore the experiences of aging in place among older canadian women with physical limitations who live alone. our research questions include: ) what is it like to live at "home" alone for older women with physical limitations? ) what support do they receive and how? and ) what are the enabling and disabling factors for their independent living? this study employed a qualitative research methodology (merriam & tisdell, ) , more specifically, combining personal narrative analysis (maynes, pierce, & laslett, ) with a narrative gerontology approach (de medeiros, ) . a qualitative approach lets us explore inductively how older women construct and make sense of their experience of aging in place (merriam & tisdell, ) , connecting their individual experience and life trajectories with broader cultural and social forces (maynes et al., ) . this reinforces what narrative gerontology advocates: listening to older people's lives as stories to understand their social world -personal, interpersonal, structural and cultural (de medeiros, ) . this study is part of a larger study, and ethics clearances were obtained from the research ethics boards of both researchers' universities. we recruited participants in two areas (a large metropolitan area and a medium sized city) in southern ontario. the criteria for inclusion were: women years and older, who lived by themselves at home with chronic physical conditions, and who were using or had used home care services. following the notion of aging in the right place, we included both regular house, condominium, and apartment, as well as alternative housing such as assisted living and community housing for seniors. we created a flyer, noting we were "looking for participants in a research study to learn their experience of and opinions about living with chronic physical conditions." approximately flyers were either posted in their residences or directly delivered to potential participants through personal support workers (psws) in collaboration with five different community organizations. recruitment was harder than we had expected. since only two participants voluntarily called back, we asked our participants, colleagues, and friends to deliver the flyer to whoever might meet the criteria. eventually, we had interviewees. although every interview will be used in our larger study, participants met all the criteria for this study. the participants ranged between and (the average age was ), and lived in various residential types in varying states of health. all have been given pseudonyms (see participants' profiles in table ). the data collection was conducted in the spring and summer of . the first author and a student research assistant conducted all interviews together. eleven interviews were conducted in participants' homes and one was in a public space. visiting their residences let us observe their daily living and neighborhood environments. each interview lasted from to min. we began by asking participants to tell us their life histories, followed by questions about their daily and weekly routines, current physical condition, strategies and challenges for managing their independent living, the support they receive, and their opinions about aging in place in general. since one chinese immigrant participant (hong, ) had difficulty speaking english, her daughter (lin, ) joined the interview as a translator, also providing some of her own insights as a family carer. following each interview, we provided a gift card of $ with a thank you note. then the two interviewers debriefed each other, recording what they had noticed in the field notes. all interviews were audio recorded, transcribed verbatim, and sent to participants to check accuracy and to modify if requested.the twelve transcripts comprised pages in total. following the steps of thematic analysis (merriam & tisdell, ) , we started open coding by reading the first participant's data set (transcript and field notes), then underlined any segments that might be meaningful and attached labels (i.e., code and themes). next, we moved to axial coding by sorting these codes and themes into more comprehensive groups (i.e., categories). then, we created a matrix to display the categories, themes, and supporting quotations for the first participant transcript. we went through the same procedures for the second data set, and compared the two matrices to create a master list of crosscase categories and themes. this master list was used as a basis for analyzing the other participants' data. comparing all participants' matrices, we generated four overarching themes as findings. to increase trustworthiness, our design included data triangulation, member checking of interview transcripts, a reflexive journal, and peer debriefing with research team members (creswell, ; merriam & tisdell, ) . we found the following four overarching themes: ) striving to continue on "at home", ) living as a "strong independent woman", ) the help needed to support their "independence", and ) social activities to sustain self. these overarching themes contain several subthemes. the first theme involves our participants' efforts to live in their homes comfortably and safely. as shown in table , many participants had lived in the same residence for decades, while a quarter had moved in the past four years due to changes in their mobility or marital status. in any event, all participants seemed comfortable in their residence, which they called "home". the first thing that we noticed was that these homes preserve their personal histories and identities. their well-kept living rooms were stuffed with vintage furniture, family photos, art, crafts, books, instruments, souvenirs, plants, pets, etc. participants four participants mentioned they might have to move in the future when they could no longer take care of themselves. yet their narratives suggested the difficulty of moving to alternative housing. certainly, i couldn't afford one of these fancy private assisted retirement homes. i've been to one of them to visit a friend of mine. she pays about $ a month for one room. i cannot afford that on my pension (dorothy, ). my mom [hong, ] is on the waiting list. well, it's been years already since she registered. it's one of the chinese long-term care homes. […] oh, yes, it's common. they say it normally takes over years! (lin, ). these comments underline the lack of affordable alternative housing many older adults face. during our visit, we were also impressed by their efforts to control their home environment to live safely. all participants had at least one chronic health condition. however, their biggest challenges were mobility issues -especially difficulty in walking, falls, and the fear of falling. despite their use of mobility aids (e.g., cane, walker, wheelchair), many participants talked about their occasional falls. all had made some home adaptations by installing safety features (e.g., staircase railing, grab bar, special chair and non-slip mat for bathrooms). they were also using assistive devices. ten of participants carried an emergency alert pendant or had installed an alert system with pull cord for their bathrooms. this was a lifesaver for some. valerie, , who has had multiple falls, related: i've used it twice. one time, they were able to get in through the kitchen window. the other time, i was doing christmas decorations when my daughter phoned, and when i turned, i fell. my daughter phoned a friend's husband to come, but before he arrived, i phoned the emergency alert and asked them if there was a particular way he should pick me up. they immediately sent somebody and got me on the chair. valerie's story suggested how unexpectedly and easily falls can happen at home, and how the assistive device helps in those instances. many participants were also using other technologies to help increase their sense of control and autonomy. half used a tablet or a computer for frequent communication with their families, reading news, and searching information. a participant with vision problems showed us a sight enhancement reading machine. one had a mobile chair lift for the staircase. the most advanced case of impairment was renelsa, who at spent most of her day in bed due to her frailty, but she could still live alone in her one-bedroom apartment in community housing. her building had a security camera to screen visitors, and her apartment door could be opened with a remote control beside her bed. we had no idea about how limited her mobility was until she greeted us in her bedroom. participants in assisted living appreciated similar safety features in their units, and the railings in the hallways and elevators. in addition, mei lien, , explained how her residence gave her "peace of mind": "last year, in the middle of night, i had to call somebody, and they [staff] came up. i don't have family in canada, so at least you know somebody is there if you call". margaret, , who was recently widowed, reflected on her decision to move from her house to a seniorfriendly condo: the very last thing i wanted to do was move into this building… do i want to live here? no! but should i live here? absolutely! … if you think your health is going to be the same tomorrow as it is today, you are wrong. we all progress to some extent from day to day … i did not know the presence of a garbage disposal in the hallway was so convenient. so in the big picture, it was a very wise thing. in this way, each participant was negotiating their own physical and social conditions, and actively managing to control their home environment as best they could. the second theme involves our participants' distinctive shared character. although their life histories and current conditions varied, we were struck by their positive, spirited, and persevering attitudes. contrary to our expectation, participants rarely brought up their needs. we thus had to ask if there was anything to complain about. dorothy, , who had just recovered from a fall on ice, laughed and said: well, i think, oh, god, i ache, i ache, i ache, but i shouldn't complain, especially when i see other people… at least, i can still walk around, i can still look after myself, and do my own thing in my own house. so you know, i would say i'm fortunate. […] well, you have to make the choices yourself, don't you? you either sit there and wither away, or you get involved and do something. luisa, , mentioned that she had learned it from her role model: i am a contented person. i am not always looking for what i don't have. i learned that from my mother. she independently lived in her own apartment until , climbed stairs to the fourth floor, and always baked and cooked for visitors. you know, she never complained about her situation. she was fiercely independent. as these comments imply, many of our participants held to a similar principle in their lives. in fact, participants commonly described themselves as brave, independent women. their life stories were full of personal and historical events: the great depression, world war ii, immigration, marriage, divorce, separation, accident, the deaths of spouses, children, and friends, and their own health problems. every participant had an occupation at some point, and many repeatedly used the word "independent" to describe themselves. as hannah, , who had immigrated from germany with her husband after world war ii, put it: i was always this independent (laughter). i was married, and i was independent. i became a widow at the age of , and raised three children. when my husband got sick, i had a job [a lab aid in a hospital] and i took a year of absence to take care of him at home. but i needed the money, so i cleaned houses, took in other people's clothes. i wanted my children to have a better education. i never went on welfare, i worked and all my children went to university. if you came from a different country, you help yourself, you don't rely too much on the country. it's my job to look after the family. a former university professor, margaret, who was mourning her husband's death and managing her own health problems, described her efforts to be a strong role model for others at years old: i am very strong-willed person. i was always a determined youngster. even as a girl, i was an independent child (laughter). even now, i just have to get really strong to be a good role model for women. i always try to be, because who is going to be the one to make me look and feel strong? me! you will only be strong if you work to be that way. […] i just live today, that's exactly how i think. i believe you stay the strongest person you can be each day you are alive. as these comments suggested, our participants' self-identity as strong independent women developed through various life experiences, sustains them in the face of the challenges of later life. nevertheless, we also learned that participants' "independent" lifestyles were supported by many other people in a mix of formal and informal care. due to our recruitment criteria, all participants had had an experience of publicly funded "formal" home care. however, at the time of our interview, only four were eligible for long-term home care, receiving min to . h a day. for the other eight participants, publicly funded home care ended two to three months after a hospitalization. once this post-acute care was over, they were back on their own. the four participants who could afford it hired a paid housekeeper a few hours a week. two more, thanks to their retirement benefits, continued regular physiotherapist visits at home or attended weekly exercise classes through community agencies. compared to those living in regular houses or apartments, participants in assisted living had an advantage in the availability of and accessibility to long-term home support services right in their own buildings. however, some expressed hesitation to use additional support services due to their worry about the additional cost: "if you need the extra service, you have to pay. it depends if you or your family can afford it. so you just hope and pray you won't need more services" (mei lien, ). like mei lien, many participants saw cost as a barrier to longer-term formal home care. as mentioned before, however, none explicitly advocated a more affordable publicly supported long-term home care system. in contrast, participants talked much more openly about informal care and support -their reliance on their family members, friends, and neighbors for regular help for transportation and household chores. ten out of participants, regardless of residential type, had at least one close family member nearby. while most participants still managed to clean their homes, do laundry, and cook simple meals, carrying groceries and to taking public transportation were getting harder. family members were the primary source for a wide range of household chores. luisa, , described the support from her son's family: it helps me a lot that my son and daughter-in-law live here [in the same city]. i've been calling them to do things. he installed the railing on the basement stairs, because i've had three falls since last december. it just makes me feel more secure. and my daughter-inlaw takes me to a rheumatologist in another city, because i don't drive highways anymore. for participants whose family members lived far away, friends and neighbors were crucial sources of social support: "i have a good friend who takes me grocery shopping and to doctors' appointments" (hannah, ); "when i had the cancer, i had radiation times in december. every morning i told my friends, i cannot do it one more day, but i did thanks to them" (elizabeth, ). as these comments suggest, most participants were grateful for the informal support and care provided by family members, friends and neighbors. clearly, these provided crucial instrumental and emotional support to all participants. overall, participants' narratives suggested an imbalance between formal and informal home care and support. even for participants receiving publicly funded long-term home care, that was not enough to live alone at home with disability and frailty, due to the limited time and tasks performed by the personal support workers (psws). for example, although psws help renelsa three times a day for a total of . h, it is her brother who brings over meals twice a week to store in her freezer. for hong ( ), who speaks limited english, communication with the psw is challenging. as her daughter said, "the agency working in this building has no psw who speaks chinese. for showering, communication is very important. that's why i need to translate. otherwise, i could be preparing breakfast during that time" (lin, ). participants in assisted living also reported regular informal support from their family members. katharine, , who no longer cooks for herself, mentioned: "i can have dinner at the dining hall downstairs, but my niece and nephew do weekly shopping for my breakfast and lunch." compared with participants living in houses, however, those in assisted living did not have to rely family and friends for daily personal care. overall, regardless of residential type, our participants' narratives suggest their independent life was unattainable without support from many others. the fourth theme involves the benefits of opportunities for continued social participation. despite noticeable physical discomfort, most participants kept trying to maintain the activities and the relationships that they valued, which were clearly an important part of their social identity. three participants living in houses were still earning a small income. many participants also kept volunteering in their communities. in particular, participants in assisted living had many opportunities within their own buildings. for example, tami, , a master of d origami, taught it to her fellow residents while volunteering at a nursing home once a week. as she explained: in , when i got this problem [a rare and progressive degenerative disease], i started volunteering. the volunteer work makes me happy. sometimes, it's just sitting and talking to them [the residents in a nursing home]. but if i talk to them, they smile. they are losing their smile all day, so i want to make them smile. smile … like cheeks up. their smiles make me happy. like tami, many participants mentioned their joy at making themselves useful to others, despite, or possibly because of, their own mobility and health challenges. tami also appreciated the wheel-trans system that made her volunteering possible. most participants also stayed active in the groups to which they belong. elizabeth, , a former entrepreneur, described her monthly routine: "i go to church on sundays, probus club and torch club once a month…i also go to all sorts of classes". although elizabeth had no family members in canada, her long-term involvement in her local community had helped her develop a circle of good friends who she could rely on. renelsa, , a former nurse and devoted christian once nicknamed "the sister in the operating room", could no longer attend church, so three fellow congregants visited her twice a month: "on sunday, we have church right here in my apartment! i really look forward to when they come". many residents in assisted living had an even busier schedule of social, cultural, and physical activities. emily, , showed us her monthly calendar on which she had circled her activities. on some weekdays, her schedule is packed from : am to pm! we also noticed a notable difference in the accessibility for exercise between those living in their own house and apartment and those in assisted living. most participants in assisted living continued to attend using their canes and walkers, while those living in their own houses stopped going to exercise classes in their communities due to a lack of transportation and coverage for long-term physiotherapy. participants' narratives make it clear that these opportunities for civic engagement and social and physical activities give them a routine to leave their "homes" to socialize, and enable them to keep playing a social role in their communities. moreover, older women mutually support each other in various ways by giving rides, bringing soups, etc. they not only receive support from others, they kept providing support to each other. overall, our study's findings illustrate how older women living alone with physical limitations can, with support from others, manage to maintain their independence in places where they feel "at home". all were achieving "residential normalcy" (golant, ) in "homes" that were "uniquely their individual domain" (kontos, , p. ) , where they could feel comfort, autonomy, security, self-identity, and continuity of self (golant, ; stones & gullifer, ; wiles, leibing, guberman, reeve, & allen, a) . their familiar belongings-what coleman and wiles's ( ) termed their "objects of meaning"-symbolically connected their past, present, and perhaps future selves. this also overlaps with the concept of "belonging". as wahl et al. ( ) noted, familiarity, routines, and emotional attachment developed over time help preserve identity and enable aging well in the right place. despite their physical discomfort, all were "fiercely independent", a phrase used by two participants (elizabeth, ; louisa, ) . as prescribed by aging in place policy, they strove to alter their home environment to live as independently and safely as possible, deploying the strategies and resources available and affordable in their contexts. they practiced problem-focused "assimilative coping", but many also used emotion-focused "accommodative coping" by accepting and being content with what they have (golant, , p. ) . these conscious behaviors exhibit our participants' "competences" (lawton & nahemow, ) and "agency" (wahl et al., ) , another enabler in person-environment interactions. one unexpected finding is their emphasis on being strong-willed "independent women". this self-image, developed over their life course, provides a psychological resource to cope with challenges in later life. clearly, they are "resilient" people (golant, , p. ) who are motivated and confident, with the physical capabilities, mental stamina, and flexibility to find appropriate solutions to the environmental obstacles they face. yet, based on their life stories, we suspect that their resilience is not an innate personality trait so much as an ability to "adapt well" learned and developed over time in relation to others and to their environments ( van kessel, ; wiles, wild, kerse, & allen, b) . we found this learning process to be resilient operating even among very old and frail participants. this supports peace et al.'s ( ) finding that, while frailty and decline of personal competence are related, they are not synonymous. older adults can confront challenges by bringing their life experiences to their person-environmental interactions. despite their limited mobility, many stayed involved in social and volunteer activities, using their skills and sustaining and developing relationships. importantly, our participants did not passively receive care. they also actively provided it to others. this finding overlaps with the concepts of "vitality and agency in frailty" for preserving selfidentity and continued self-development in later life (bjornsdottir, ; latimer, ) . it also highlights the crucial role of opportunities for social participation, meaningful and reciprocal contribution, and relationship building to aging in place. a recent increase in innovative community-based participatory approaches to aging in place, such as the naturally occurred retirement community (norc), for example, includes this reciprocal exchange of support and care by creating resourceful community environments (greenfield, scharlach, lehning, & davitt, ; sixsmith et al., ) . nonetheless, our findings also suggest some disabling factors. the constant "balancing act" (golant, , p. ) person-environment interactions in later life demands was difficult for some, especially for those with severe mobility limitations, multiple comorbidities, few close family members and friends, and low income. also, the quality of our participants' aging in place was influenced by local environments, including the availability of affordable home care services, physical activities, and safe and reliable public transportation (e.g., wheel-trans). most notably, our participants were facing the challenges of pain and balance: falling posed a real threat, as found in previous studies (e.g., bushnik et al., ) . nevertheless, for many participants -especially those living in houses and apartments without transportation and private home care insurance -regular exercise classes, physiotherapy, and fall prevention programs were neither affordable nor accessible. given the proven benefits of interventions for falls and fear of falling (e.g., whipple, hamel, & talley, ) , it is essential to develop strategies to make those programs more available. policies in aging, health, and social services should support greater collaboration between community-based formal and informal care (ryser & halseth, ) . in the current discourse surrounding aging in place, independent living tends to refer to an autonomous lifestyle achieved through the personal efforts of individuals. in reality, however, as our findings show, aging in place for older women with physical limitations inevitably requires a view of "independent living" which promotes reciprocity and interdependence between individuals and their communities, including both formal and informal supports. in other words, as golant ( , p. ) advocated, we need to adopt an "it takes a village" perspective. nevertheless, consistent with previous studies (johnson et al., ; kadowaki, wister, & chappell, ) , publicly supported long-term home care -especially for maintenance and prevention purposes, such as home support services and physiotherapy -was still unavailable for many of our participants. our study adds further contextual evidence to canada's need for the publicly supported long-term home care system many have advocated over the past decade (canadian home care association, ; gilmour, ; kadowaki et al., ; special senate committee on aging, ; turcotte, ) . overall, the findings of our study support the notion of aging in the right place proposed by golant ( ) . they suggest that, despite their tireless individual efforts to be independent in a place of their own, older women can reach a point where the changing balance between personal competence and environmental pressure requires a new strategy to maintain self-identity, what peace et al. ( ) term "option recognition" (p. ). participants who could afford it or were eligible for public subsidy often moved into assisted living to regain control. given the lack of a universal long-term home care system in canada, moving to assisted living helps reduce the heavy burden placed on some older adults and their family members (ryser & halseth, ) . at the same time, our participants' narratives reaffirm that alternative senior residences -such as active adult communities, assisted living, and continuum care retirement communities -are not a readily available or affordable option for many middle-income older canadians (dalmer, ) . finally, the most unexpected finding in our study is the collective silence of older women, the so-called "shadow story" (de medeiros & rubinstein, ) , about their unmet need for more formal and structural support reported in previous studies (e.g., canadian home care association, ; gilmour, ; turcotte, ) . this may be partly because the interviewers were "others" (dorothy, ), making it hard for participants to reveal their true feelings, and partly because respondents wanted to present themselves as role models for their interviewers, who were of their daughter's and granddaughter's generation. complaining and demanding that their needs be met contradicted their core principle of "being independent". finally, adopting the neoliberal rhetoric of being self-reliant and autonomous model citizens, older women may see their growing care need for daily activities as an individual matter that they should take care of themselves, rather than a structural issue connected to the long struggle over public policy. further study is required to clarify these points and investigate how a "sociological imagination," as coined by c. wright mills ( ) , might be used to collectively empower older women and inform public policies alike. this study has several limitations. due to our small number of selfselected participants who are resilient and have positive outlooks, our findings reflect more the experiences of older women who are successfully aging in the right place, despite their physical conditions. the voices of older adults who live with cognitive impairment, depression, and social isolation, or whose lack of resources make them more vulnerable, are missing. furthermore, the data was collected before the covid- pandemic, which has likely altered older women's perceptions and experiences. all these areas are important, and deserve further study. despite these limitations, our research provides a valuable window into experiences of aging in the right place of an understudied groupolder women living on their own with physical challenges in canada. no matter how fiercely and successfully independent older women try to be, framing aging in place as a matter of individual efforts alone is misguided. it is crucial that more structural supports and improved community-based care that is informed by recipients themselves become an integrated part of public policy. the shifting of public perceptions from aging in place to aging in the right place has the potential to foster subjectively-defined aging well among older adults with different needs and resources. we hope these findings will encourage further studies and the political will to make aging in the right place a real option for older adults in canada and far beyond. this study was funded by a grant from the japan society for the promotion of science (# k ). none. rehabilitation therapies for older clients of the ontario home care system: regional variation and client-level predictors of service provision holding on to life': an ethnographic study of living well at home in old age health reports. health-adjusted life ex seniors' housing report -ontario better home care in canada: a national action plan health care in canada, : a focus on seniors and aging being with objects of meaning: cherished possessions and opportunities to maintain aging in place qualitative inquiry and research design: choosing among five approaches a logic of choice: problematizing the documentary reality of canadian aging in place policies narrative gerontology in research and practice shadow stories" in oral interviews: narrative care through careful listening thinking about your future? plan now to age in place -a checklist report on housing needs of seniors transitions to longterm and residential care among older canadians unmet home care needs in canada commentary: irrational exuberance for the aging in place of vulnerable low-income older homeowners the quest for residential normalcy by older adults: relocation but one pathway women's housing challenges in later life: the importance of a gender lens using ecological frameworks to advance a field of research, practice, and policy on aging-in-place initiatives a conceptual framework for examining the promise of the norc program and village models to promote aging in place senior women. women in canada: a gender-based statistical report. catalogue no. - -x. ottawa: statistics canada no place like home: a systematic review of home care for older adults in canada influence of home care on life satisfaction, loneliness, and perceived life stress resisting institutionalization: constructing old age and negotiating home home care and frail older people: relational extension and the art of dwelling ecology and the aging process utilization of formal and informal home care: how do older canadians' experiences vary by care arrangements social work and aging in place: a scoping review of the literature telling stories: the use of personal narratives in the social sciences and history qualitative research: a guide to design and implementation housing-related control beliefs and independence in activities of daily living in very old age option recognition' in later life: variations in ageing in place informal support networks of low-income senior women living alone: evidence from fort st ageing well in the right place: partnership working with older people. working with older people canada's aging population: seizing the opportunity aging and place: clarifying the discourse census in brief no. : living arrangements of seniors statistics canada catalogue no. - -x . ottawa, on: statistics canada the daily. canada's population estimates: age and sex income of individuals by age group, sex and income source, canada, provinces and selected census metropolitan areas at home it"s just so much easier to be yourself': older adults' perceptions of ageing in place living alone in canada. insights on canadian society canadians with unmet homecare needs the ability of older people to overcome adversity: a review of the resilience concept aging well and the environment: toward an integrative model and research agenda for the future fear of falling among community-dwelling older adults: a scoping review to identify effective evidence-based interventions the meaning of "aging in place" to older people resilience from the point of view of older people the sociological imagination we would like to send our heartfelt thanks to all participants in this study for generously sharing their life experiences and insights. our appreciation also goes to the organizations and their staff members, our colleagues and friends, who assisted in our recruitment, and ms. jessica wong and ms. ramesha ali for their assistance in data collection. we extend our acknowledgement to dr. beard and two anonymous reviewers for their encouraging and constructive feedback. key: cord- -apgdzgfz authors: lewis, thomas j; huang, jason h; trempe, clement title: reduction in chronic disease risk and burden in a -individual cohort through modification of health behaviors date: - - journal: cureus doi: . /cureus. sha: doc_id: cord_uid: apgdzgfz introduction health risk factors, including lifestyle risks and health literacy, are known to contribute to the chronic disease epidemic. according to the centers for disease control and prevention (cdc), chronic diseases account for % of healthcare costs, morbidity, and mortality. in the united states, healthcare providers attempt to modulate a limited set of risks. however, chronic diseases continue to proliferate despite expansion of wellness programs and drugs to manage and prevent chronic conditions. pandemics, exemplified by severe acute respiratory syndrome coronavirus (sars-cov- ), show that people in good health suffer mortality rates at % the rate compared to those with pre-existing chronic conditions. healthcare costs and morbidity rates often parallel mortality rates. new root-cause risk and health tools that accommodate low health literacy and are linked to personalized health improvement care plans are needed to reverse the chronic disease epidemic. reported here is a study on manufacturing employees in the midwest us using a personalized and group approach to chronic disease reversal and prevention which may also find utility in pandemic severity and policy decisions. methods health, lifestyle, behavior, and motivation data were collected on individuals at the beginning of a nine-month disease reversal and prevention program. the data were updated every two to six months over the period. inputs included information from a novel health risk assessment, serum biomarkers specific for chronic disease, and traditional medical information. using all these data we generated robust, personalized, and modifiable care plans that were implemented by the participant and guided by a care team including health coaches and medical providers. periodic renewal of profile data and biomarkers facilitated adjustment of care plans to optimize the path toward health goals set mutually by the participant and the care team. results ninety percent of participants experienced a favorable reduction in chronic disease biomarkers. the reduction in serum biomarkers coincided with a reduction in disease and risk attributes based on medical chart data and before and after interviews. hemoglobin a c, for example, lowered in all but one participant concomitant with reported improved energy and reduced need for medications in the majority of participants. markers of inflammation lowered across the population. most importantly each individual reported improvement in their overall health. conclusions this simple, inexpensive, root-cause based risk and health approach generates a “do no harm” action plan that guides a care team, including the participant, on a path to improved health. the data demonstrate that changes in a novel risk calculator score coincide with changes in sensitive biomarkers for chronic disease. when the risks of an individual are reduced, the biomarkers reflect that change with self-reported wellbeing also improved. this program and process may be of value to society plagued with escalating levels of chronic disease and merits further study and implementation. developed nations, and particularly the united states, continue to confront a chronic disease crisis. the world health organization (who) reported that in , non-communicable chronic diseases including: cardiovascular diseases, diabetes, cancers, and chronic respiratory diseases, accounted for / of deaths worldwide [ ] . the institute of medicine reported that america is less healthy compared to high income nations in obesity, diabetes mellitus, heart disease, chronic lung disease, and disability [ ] . the organization of economic cooperation and development (oecd) tracks the health of developed nations. the u.s. scores in the lower half among these nations on all major indicators of health, and longevity. when considering that the per person per year cost of healthcare in the united states is more than two and a half times that of the oecd nation average, yet our residents live . years less, a health paradox exists in the united states. this u.s. paradox is the worst cost-to-value benefit for chronic disease outcomes compared to the average of other developed nations. the chronic disease management system is failing people at both ends of the health spectrum. a root of the problem is that health and prevention recommendations currently supported by the major medical societies have proven ineffective at reversing or preventing chronic diseases. laboratory tests in common use remain of limited scope and provide little insight into chronic health status. pharmaceuticals prescribed based on test results have poor absolute statistical success at preventing or reversing disease. these assertions are borne out since % of the nation's nearly $ trillion in annual health care expenditures are for chronic conditions per the cdc. and the situation is not improving, for example, cardiovascular disease mortality, managed with statin drugs, blood pressure medications, and other usual care approaches across broad members of the u.s. population, increased nationally by . % between and [ ] . on average, residents of the united states with five or more chronic conditions spend times more on health services than people with no chronic conditions [ ] . as of , % of u.s. adults had at least one chronic condition, and % had more than one chronic condition. five percent of the population accounts for an estimated %- % of total health care expenses [ ] . the most expensive health conditions account for % of total health care expenses. the financial and productivity costs impact our corporations, who fund over half of the national healthcare at a price of roughly % of their gross revenues. and much of this cost is segmented in high-cost beneficiaries where, for example, the top % of claimants cost $ , /y compared to the population mean of $ /y. in a report compiled by the health care cost institute, there is a surprising large turnover from year to year among the highest cost healthcare spenders. three out of five top spenders in any given year were low or moderate spenders in the prior year. in , only % of the top % of spenders were in the top % of spenders in . moreover, this trend was consistent in each year from to . there is a need for better predictive analytics to determine who is and, more importantly, will be in this significantly high-cost segment of any population as a current tool, claims data, lacks predictive power. in pandemics, standard tests provide little information on projected outcomes, rather they simply indicate exposure and potential immunity. healthy people are much less likely to die compared to unhealthy or older people. physiological health, the main concern of practicing clinicians, is not well characterized through these tests. further, the main cause of death appears to be cytokine storm syndrome which is driven by innate, not adaptive immunity [ ] . thus, antibody testing does not adequately describe disease risk or severity. validated data on severe respiratory viral diseases and the correlation between mortality, immunocompromised status and existing chronic conditions in infected individuals indicate that a broad set of blood-based biomarkers may best serve to stratify risk and to set policy on containment strategies in populations [ ] . currently, the policy is being established with an incomplete set of evidence. in vivo blood biomarker analysis offers considerable opportunities for individual and population risk measurement. these tests afford fast analytical turn-around time, quantitative measurement, accessibility, serial monitoring and ready availability. in some instances, rapid and continuous monitoring is available. the measurement of and changes to a broad range of modifiable risk factors, and biomarkers connected to immune system activity through cytokine surrogates, offers the most important opportunity for the prediction of disease and improvement in global chronic and pandemic disease status. most industries recognize the value of early problem intervention. in the waste management industry, for example, there is a clear hierarchy of: . source reduction, . recycling, . treatment, and . land disposal. in healthcare, there is also a potential for a four-tiered approach to health maintenance: . prevention, . mitigation of asymptomatic disease in people with elevated predictive biomarkers, . mitigation upon the earliest detectable signs of early disease (dry macular degeneration is an example), and . advanced root-cause mitigation approaches within disease management approaches. most of the efforts in today's healthcare is on disease management with usual care which is only a small part of this suggested four-tiered approach. the who addressed major causes of chronic diseases with modifiable risk factors being: unhealthy diet; physical inactivity; and tobacco use. in addition, the who stated "these causes are expressed through the intermediate risk factors of raised blood pressure, raised glucose levels, abnormal blood lipids, overweight and obesity. the major modifiable risk factors, in conjunction with the non-modifiable risk factors of age and heredity, explain the majority of new events of heart disease, stroke, chronic respiratory diseases and some important cancers. the relationship between the major modifiable risk factors and the main chronic diseases is similar in all regions of the world." studies show that the u.s. experiences the same risks as exist globally. dietary factors, alone, are associated with nearly half of all cardiometabolic deaths. the highest proportions of cardiometabolic deaths were estimated to be related to excess sodium intake, insufficient intake of nuts/seeds, high intake of processed meats, and low intake of seafood omega- fats. dramatic changes in disease rates among migrating populations indicate that the primary determinants of these diseases are not genetic but environmental factors, including diet and lifestyle [ ] . studies on twins separated at a young age corroborate that chronic disease is much more related to environmental factors. expansion of the depth and breadth of risk assessment and concomitant prevention and disease amelioration programs represent an unmet healthcare need. a well-studied disease prevention arena is corporate wellness programs. most of these programs rely on "usual care" that includes: basic dietary recommendations, weight loss, smoking, alcohol consumption and metabolic and lipid index targets. a broad-based team of wellness professionals and academics evaluated workplace wellness programs. they unanimously concluded that few wellness programs meet expectations and most are abysmal failures. what separates bad, good, and great programs is "a combination of good design built on behavior change theory, effective implementation using evidence-based practices, and credible measurement and evaluation." to further support the need for more thorough risk assessment, in a global study of risks, the authors concluded "increasingly detailed understanding of the trends in risk exposure and the relative risks for each risk-outcome pair provide insights into both the magnitude of health loss attributable to risks and how modification of risk exposure has contributed to health trends [ ] . these types of data clearly illustrate a path to improved health outcomes through broader and deeper precision and personalized assessment. the risk evaluation tool used in this study, the chronic disease assessment™ (cda), is an on-line health risk assessment and mitigation tool and involves answering approximately questions that probe deeply into lifestyle and environmental sources of risks, behaviors, health attitudes, readiness to change, current and past complaints, problems and diagnoses. the output of the cda is an overall risk score and then sub-sets of scores by risk categories, and a score for each question/answer combination. the overall raw risk score is converted into a letter "grade" reflecting the extent of the individual's risk "portfolio." the letter grade is provided to participants as an easily understood value for their risks, to overcome a lack of health literacy that especially impacts high risk populations. in addition, the cda output generates a series of actions that provide personalized education and actionable solutions to each risk in a participant's risk portfolio. finally, a health revival care plan™ is generated from the risk portfolio, and adjusted by the health coach and the participant, to create a simplified, personalized roadmap to overcome risks and improve health. a major impediment to health improvement is low health literacy. the de facto intervention perpetuating this problem is a prescription for symptom management that requires little knowledge by the patient. deficits in health literacy are associated with poorer health outcomes and higher health-related costs for both individuals and systems. improved health literacy has been associated with reductions in risk behaviors for chronic disease, and decreased rates of hospitalization [ ] . health literacy is a critical and under-examined component of health disparities. according to the national assessment of adult literacy, over a third of u.s. adults have basic or below basic health literacy and have difficulty managing common health-related tasks. limited health literacy poses a significant economic burden to our society, with national estimates indicating that low health literacy costs the u.s. healthcare system from $ to $ billion each year in healthcare dollars [ ] . the nexus of this program, including the cda risk portfolio, actions, care plans, and health coaching, is designed to meet and exceed the united states department of health and human services national action plan to improve health literacy's three goals: ensuring equitable access to health information; creating 'person-centered health information and skills' and supporting the development of the skills needed to attain and maintain good health. a final important aspect of this process, not articulated by the action plan, is illumination of the connection of risks to problems and complaints. the cda collects and reports risks, problems, and complaints together. thus, participants are able to "connect the dots" between risks and problems, like oral health and joint pain or carbohydrate intake and fatigue, as examples. these upstreamdownstream connection realizations improve health literacy and stimulate more sustainable change which manifests in the adoption of actions and plans to eliminate the risks as a solution to their problems as opposed to the usual care option of a drug to control symptoms. this process empowers individuals to be a participant in their own health improvement through recognition of their control over causes and outcomes. within this study, health coaches interacted face-to-face and electronically with participants and groups of participants to implement care plans. coaching activates patients to change through collaborative learning and social support. patient engagement and p medicine, defined as predictive, preventive, personalized and participatory, is an increasingly important component of strategies to prevent and reverse chronic disease, at least within the functional and integrative medical communities. interventions that tailor support to the individual's level of activation, and that build skills and confidence, are effective in increasing patient activation. more highly activated people are more likely to engage in healthy behavior such as eating a healthy diet and getting regular exercise while avoiding health-damaging behavior such as smoking and illegal drug use. these behavioral changes have led to lower rates of hospitalizations and emergency department visits, compared to less activated patients [ ] . a bridge between risk factors and modification in certain intermediate factors like blood pressure and obesity are changes to blood-based biomarkers, which are more objective measures of health. the most routinely performed tests in usual care are for the assessment of kidney and liver health, blood chemistry, lipid markers and metabolic markers. heart disease continues to be the number one cause of morbidity and mortality in the u.s. and globally despite the broad use of cardiovascular disease medications for both prevention and intervention. a study of , patients hospitalized with a heart attack between and showed that almost % had ldl cholesterol levels within guidelines [ ] . these data imply there is room for testing to augment evaluation of cardiovascular risk and cause. in older populations, "concentrations of homocysteine alone can accurately identify those at high risk of cardiovascular mortality, whereas classic risk factors included in the framingham risk score do not" [ ] . in healthy men, adding creactive protein levels to traditional risk factors, the reynolds risk score, improved cardiovascular risk prediction. the intermountain risk score uses common blood measures and assesses risk from the group of markers to develop a risk score. although limited in application, this scoring system has been reported to be predictive of increased mortality risk and provides patients with a more definable goal, the improvement of the score. more comprehensive assessments for risk and disease are emerging including the "allostatic load" and "inflammaging" concepts. each of these approaches considers a broader molecular view, rather than an organ system view of disease. according to mcewen, "when these (our body's) adaptive systems are turned on and turned off again efficiently and not too frequently, the body is able to cope effectively with challenges that it might not otherwise survive. however, there are a number of circumstances in which allostatic systems may either be over-stimulated or not perform normally, and this condition has been termed "allostatic load" or the price of adaptation" [ ] . diabetes is a relevant example, where insulin production is frequently elevated in response to regular highly absorbable carbohydrate intake. claudio franceschi coined the term "inflammaging" in to describe the concept of low-grade chronic inflammation and its impact on health. inflammaging was described as an extension of the "network theory of aging" [ ] . similar to the allostatic load, a global reduction in the capacity to cope with a variety of stressors and a concomitant progressive increase in proinflammatory status are considered the major characteristics of the inflammation aging process and susceptibility to premature disease and mortality. biomarkers for inflammaging are readily available and inexpensive but seldom obtain in usual care, especially in the implementation disease prevention strategies. according to gay et al., the allostatic load leads to dysregulation of the neuroendocrine system and subsequent elevation in inflammatory markers, leading to metabolic syndrome and chronic diseases such as cardiovascular disease [ ] . thus, the allostatic load and inflammaging are both measured, at least in part, with inflammatory markers like c-reactive protein, cortisol levels, glycosylated hemoglobin, white blood cell counts, and fibrinogen as examples. independent of inflammatory markers, multiple biomarkers, in general, improve the predictive power of a panel. in a study of people assessed with biomarkers, persons with multi-marker scores in the highest quintile as compared with those with scores in the lowest two quintiles had elevated risks of death and major cardiovascular events of . and . (adjusted hazard ratios), respectively [ ] . this far exceeds the predictive hazard ratio for cholesterol which varies from . to . depending upon the study [ ] . a hazard ratio of < means cholesterol levels were determined to be protective and stave off early mortality. numerous studies and reviews consistently show the value of multiple markers in real-world prediction of disease events and premature mortality. the chronic disease temperature™ (cdt) risk scale used in this study combines emerging concepts for improving the evaluation of disease risk and measurement of active disease. the significant attributes of the cdt scale are: . consideration of multiple biomarkers, . selection of markers based on traditional and new predictive markers based on inflammaging and the allostatic load, . harmonizing each marker to a standard endpoint -increase in early mortality risk, . consideration of risk contribution based on log-linear deciles of marker levels and individual marker hazard ratios for mortality, and . combination of the risk values from each marker into a single number score to accommodate limited health literacy and to set an understandable objective target for health improvement. the aggregate cdt score is an indicator of early mortality and associated total morbidity, while the values for each marker reflect both mortality risk and disease risk based on the association of a given marker to disease. this single number may be an important bridge to better health literacy as most patients do not understand the meaning of their current lab values. the cdt does not constitute a medical diagnosis of disease any more than does any individual marker, like homocysteine, but does statistically afford better predictive capability and measurement of disease progression or regression. the cdt output promotes the concept that health and disease lie on a log-linear continuum rather than being an on/off switch. in this study, the implementation of risk assessment, health and disease measurement, care plans, and frequent measurement leading to continuous improvement represents a needed response to challenges society faces from chronic diseases. this "systems approach" is designed to better connect across fragmented divisions in healthcare without bias of discipline. that is, fundamentally, most chronic diseases are connected at root-cause physiological processes. the ultimate goal is to create new risk/plan/action/outcome connections that facilitate learning opportunities and iterative advancement in treatment and preventative methods for chronic disease. another consideration is the order applied to the interventions including "in series" or "in parallel". an example is diabetes that needs to be managed for the prevention of heart disease, yet these diseases lie in different medical silos. the final objective ensures that workup of any individual patient, regardless of the presumed scope of the illness, embraces all possible causal factors. the purpose of this study was to assess the effectiveness and safety of this novel care model for the prevention and reversal of a broad spectrum of chronic diseases and complaints over a nine-month period. primary endpoints to assess the effectiveness of the intervention were changes in health risk assessment scoring, changes in documented health complaints, changes in medication usage, changes in vital signs, changes to individual blood-based biomarkers designed to measure chronic health, and changes to the multiple marker risk score, the cdt. we conducted an open-label, randomized, controlled, before-and-after nine-month study of a high intensity remote and on-site care intervention named a health revival process (hrp). participants included a group of individuals who, at the time, were employed by a mid-west fortune , manufacturing company with approximately , employees at that site. no formal control group was established but non-participant health status over the period was tracked using claims data for diagnoses, complaints, medication use, and healthcare spending. participation was voluntary and recruitment started in november of , implemented by our company and the employer, focused on higher claims and more chronically sick individuals who were motivated to overcome unresolved chronic health issues. no rigid participation inclusion criteria were used other than each individual had at least one diagnosed chronic condition, was formerly or currently on a medication for a chronic disease, and was a high healthcare claimant (> $ /year currently or within the past three years) if that data was available. not all participants had claims data from previous years mainly due to their health plan and choice or employment history with the company. from those interested in the program and met the criteria, retrospective health data (medical claims) were reconciled to finalize the -person cohort without consideration for a specific type of condition. although not a formal clinical study, all procedures performed in the program involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the helsinki declaration and its later amendments or comparable ethical standards. ethical oversight was provided by the existing primary care clinic management organization, but not under any formal written agreement other than to monitor for patient safety. informed consent, medical releases, and participation contracts were obtained from all participants included in the program. these documents were completed after each participant was provided detailed information about the program. all data were acquired in strict conformance with health data privacy laws by medical personnel and all stored data were contained on a health insurance portability and accountability act (hipaa) compliant cloud. the health revival process: participants in the health revival process (hrp) underwent medical history review, completed a +/-question online health risk assessment (chronic disease assessment™ (cda)) and laboratory testing for serum-based biomarkers (chronic disease temperature™ (cdt)). participants without a medical exam within the past months had one perform by our doctor, to determine their baseline health and risk status. all data obtained on participants, including problems, diagnoses, health complaints, reconciled medications, vitals, food journal, and other measurements were entered into our proprietary health revival software. upon qualifying, hrp participants began one-on-one health coaching encounters. the initial coaching session included active listening by the coach and reconciliation between the output of the cda risk assessment and health concerns, problems, and information articulated by the participant at that first encounter. any discrepancy between the responses to the cda questions and information presented to the health coach were verified and the cda was appropriate updated and annotated. the health coach, using the recommendations promoted by the up-to-date hrp software record, developed a personalized health roadmap referred to as a person's health revival care plan™ (hrcp). our medical doctor reviewed and finalized that document and then conferred with the coach on next steps appropriate for the participant. our doctor and the non-hrp medical doctors ensured that the recommendations and suggestions made by the health coach did not violate the health coaches license to provide advice. there was reasonable fidelity to the hrp delivery as everyone saw the same coach and doctor over the same time period. however, participants experienced different levels of coaching and doctor intensity based on the extent of their risk portfolio and medical needs. participants had continuous access to their health information, suggestions, and progress within the hrp software which maintained much of their personal health information. specifically, a participant could follow, track, and monitor changes in health measures and interact with specific, personalized content (written, audio, and video) curated automatically by the hrp system based on their personalized health information inputs including, their cda risk assessment, cdt markers, and vital signs recorded in the system. in addition, the participant portal included their personalized hrcp that created the structure for their hrp. participants were able to work with their health coach on the plan, follow the plan through a selfguided process, or some hybrid between the two paths. the health coach was able to monitor the self-guided process through system feedback that included reports on system logins and completed "actions" and "goals." completed actions occurred after a participant accessed content relevant to a health risk determined by the hrcp and choose a selection after reviewing the information like "completed" or "deferred." most participants relied on the health coach for structure, direction, and motivation. figure shows features of the patient portal health revival dashboard. participants in the hrp retained their existing providers for acute disease management and routine medical checkups. care coordination between existing providers and hrp care team occurred as needed. in particular, the hrp doctor and pcp discussed any possible interactions between supplements, lifestyle changes, and current medications. of frequent concern was a need to change the dose or use of insulin, other diabetic medications, blood pressure, cholesterol, and corticosteroid medications as the participant's health improved through lifestyle modification. frequency and type of biomarker tracking, beyond the before-and-after cdt labs, were individualized by the hrp doctor on the basis of care needs and progress as recorded by participants in updated cdas and health coaches in updated hrcps and coaching notes. participants on insulin were contacted at least weekly to assess any potential for hypoglycemia. either the pcp or the hrp doctor made medication modifications. chronic disease assessment: the cda was available electronically through a web browser and included +/-questions through a series of shorter surveys, with the participant able to stop and restart the survey at any point where they left off. each question included fixed answer choices from a single option to as many as options depending upon the scope of the question. in some instances, a question allowed for multiple answer selections while in others, only a single response could be recorded. each question/answer combination was given a risk score and assigned one or more attributes of risk based on our study of the medical literature for potential outcomes associated with the specific behavior attribute. the cda included consideration of common risks and disease root causes determined from our own clinical experience and published clinical case studies, population and randomized clinical trials. for example, the cda gave considered to oral health, gut health, eye health status, macro-and micronutrient imbalances, and indications of chronic and occult infection. the output of the cda was a raw score that converted to a letter "grade" reflecting the extent of the risk "portfolio" determined by the assessment. each letter grade, a-f, spanned a range of raw scores. the purpose of the letter grade was to convert a numeric value into a more meaningful and recognizable risk level. in addition, the software interface outputted an action or a series of actions for many of the question/answer pairs, through if/then/else logic. the actions are those known or believed to lead to a reduction in that risk based on peer-reviewed published studies or our own experience. the actions are bundles of content that explain the risk or potential risks and offer suggestions to ameliorate the risk. all this content was made available to participants through their health revival dashboard (hrd). example questions from the cda are provided in figure . chronic disease temperature: routine labs and the cdt biomarker panel were drawn at the on-site clinic by non-hrp technicians working for the primary care provider company. the labs drawn on each individual and the thresholds for chronic health considerations are described elsewhere [ ] . in summary, reference intervals were not used to determine health status and risk. instead, our team of biostatisticians reviewed the medical literature to determine the threshold level or levels for each biomarker, they indicated a statistically significant increase in early mortality associated with that marker. each marker was assigned escalating risk based on log-linear curve fitting to published information on mortality risk and biomarker raw value. many of the cdt biomarkers are common biomarkers with some being less commonly obtained in usual care. the ordering doctor of record was held responsible for ensuring any participant with an abnormal lab value, based on usual care reference intervals, notified the participant and arranged for appropriate care to correct the abnormal value. the "tighter" thresholds used as part of the cdt labs were used only by the hrp doctor and not used for making a medical diagnosis. instead, this more sensitive scale of normal vs abnormal lab values was used to measure changes in participant's physiology concomitant with lifestyle changes. this more sensitive scale for each biomarker and the overall cdt value, helped assess participant's health trends by recognizing that disease is not an on/off switch, but rather a continuum. for example, and hba c level of . %, although not a diagnosis for type diabetes, is a strong indicator of future type diabetes. a goal value of < . % was established for all participants to optimize insulin sensitivity and avoid future diabetes risk, assuming that value was obtained through lifestyle improvement and not pharmaceutical intervention. this logic was applied to all cdt markers. the interventions affected by the hrp through the hrcp were individualized to each participant and included a consideration of the participant's readiness to change and the likely sustainability of any given change as determined by their responses to chronic disease assessment questions and discussions with their health coach. the intensity of coaching was predetermined, but not fixed, by the cda grade. the coaching time allotted to each participant based on the cda grade is provided in table . doctor time allocation was approximately / th coaching time. the main risk considerations were a reduction in inflammation through: more movement, increased nutrient density of foods, improvement in digestion/absorption by improving gut balance and activity, increasing probiotic and prebiotics foods, elimination of high glycemic foods, better oral health maintenance, increased intake of healthy fats and omega- fatty acids, increased micronutrients to support hormone production, stress reduction, brain health through reducing whole-body inflammation, and consumption of greater amounts of fat-soluble vitamins, as examples. no specific nutrition program was recommended to the participants as a whole. instead a simple process of substitution of one food, considered of low nutrient value for another of higher value, was made as recommended by the health coach. recommendations were made on an individualized basis based on participant preferences, to affect a gradual and sustainable change from the standard american diet (sad) that was prolific throughout the cohort, to a new food consumption pattern with increased micronutrient density, fiber, and fat with less carbohydrate and sugar consumption. short term (one to three months) nutritional ketosis was suggested for a few highly insulin resistant and diabetic patients but no participants fully achieved nutritional ketosis during the nine-month period. however, these participants achieved a significant reduction in total carbohydrate consumption with a shift to low glycemic index food and those containing higher concentrations of marine, monounsaturated, and saturated fats. supplements were provided as part of the program and compliance with supplementation was near % based on self-reporting and resupply orders. at the outset of the program, after evaluation of cdt labs, cda reported dietary information, and food journals, the participants were provided any or all of the following supplements based on individually assessed deficiencies: multivitamin/mineral ( qd); vitamin d ( - , iu, qd); cod liver oil ( - g, qd); magnesium glycinate ( - mg, qd); vitamin k ( mcg, qd); probiotic ( - billion organisms, qd). supplements were provided only when deemed appropriate by the hrp doctor and were phased in then phased out over the nine-month period as the doctor determine that nutritional deficiencies or insufficiencies were being mitigated by the program. the purpose of the supplements was to quickly overcome apparent nutritional deficiencies. as part of the hrcp, foods that contained nutrients provided by the supplements were recommended and, when adopted, enabled the gradual elimination of supplementation without compromising nutritional needs. the main behavioral change strategy, executed by the doctor and coach care team, was to slowly and gradually ease a participant into change. the frequency of coaching sessions, dictated by the need of the participant (cda letter grade), including their burden or disease and risk, and their motivation, was adjusted to improve compliance. most participants suffered from some health ailment that impacted their daily wellbeing. improvement in general wellbeing, which started to be noticed by participants by the end of month , provided the motivation to continue to adopt gradual modifications to lifestyle. to help participants understand that the hrp is not a quick fix, our coaches explained that we have determined a general "rule of thumb" for the time required to improve health significantly. if a disease, like diabetes, has been slowly developing over five years, it will take at least five months of effort to reverse the disease, assuming the interventions are appropriate. outcome measures: in-clinic vital signs, health risk assessment (cda) risk score and list, and biomarkers were obtained at baseline and at the end of the -month program. problems, complaints and medications were reconciled at each health coaching and doctor encounter. fasted and non-fasted blood draws were obtained by clinic pcp staff using routine procedures. samples were provided to and analyzed by quest diagnostics using standard operating procedures. primary outcomes were: changes in biomarker values; risk scores; reported diagnoses; vital signs; weight; and medication use. secondary outcomes included reported complaints, for example, lack of energy, chronic pain, sleeplessness, mood issues, and general lack of wellbeing. the baseline demographics of the final hrp participants are presented in table . all participants were caucasian of european heritage. at baseline, % of hrp participants were actively taking pharmaceuticals for a medical problem and % were diagnosed with at least chronic condition. this reflects a substantially higher percentage of chronically ill individuals compared to the u.s. national average of % of u.s. adults having at least one chronic condition. on average, the group was taking . prescriptions per person. the major class of medications included: diabetes medications, injectable insulin, statins, blood pressure lowering, pain, mood (ssris), bisphosphonates, steroids, thyroid hormone, and proton pump inhibitors. the final participant number of was established after left the program. two were dismissed from the program for compliance reasons, four left early to join a weight loss program, two left because of the time commitment, and two left due to potential interactions between current medications and supplements as encouraged by their pcp, for a total of . %. there was no clear demographic trend between those who remained in the program versus those who dropped out. chronic disease assessment™ (cda): on average, the -participant cohort lowered their cda score by points ( %) from a raw value of to a new value of over six months. each point lowered reflected a reduction in a disease risk or resolution of a health problem or complaint. risks were scored on a - scale, with representing a minor risk or problem and representing a major risk or problem. the initial population cda grade was d+, assigned based on a range of raw numeric scores calculated from the survey, and the final grade after months of the hrp was c+. ninety-four percent of the group experienced an improvement in their risks while % of the cohort experienced a worsening of their cda grade ( figure ) . participants did not have their initial cda answers to refer to when they retook the assessment six months into the program. chronic disease temperature™ (cdt): on average, the -participant cohort lowered their cdt score from . to . . the cdt is based on a "degree" scale calculated by adding the risk contribution from each biomarker to . to arrive at the participant's cdt. the average chronic disease risk reduction in cdt was % (figure ). all % of participants whose cda grade worsened also experienced an adverse change in their cdt score. three participants improved their reported cda grade but witnessed an adverse change in their cdt. the cdt included several markers that are classified as "acute phase" reactants. in "acute-phase proteins and other systemic responses to inflammation," the authors explain that markers of chronic systemic inflammation are also subject to change acutely [ ] . for example, c-reactive protein elevates during the acute phase of pneumococcal pneumonia. c-reactive protein has an acute phase relaxation half-life of approximately one day upon removal of the insult whereas the half-life of fibrinogen is about one week. two of the three participants with an improved cda but worsened cdt experienced adverse physiological changes due to documented acute circumstances. retest was not available during the nine-month program to confirm our suspicion about the cause of the elevation. one recently underwent surgery and was recovering slowly. another participant was receiving ongoing treatment for a complex acute condition managed by the patient's pcp. other participants whose cdt worsened were in the hrp and a calorie-restricting weight loss program administered by third parties. the weight loss program was calorie counting-based with no guidance provided on macro and micronutrients. these individuals, although in the hcp, were less flexible to our coach's dietary suggestions because of the calorie restriction. for example, a participant refused to take cod liver oil because each capsule contributed approximately calories to their daily calorie allotment. our results demonstrated, in this small subgroup, that people in poor health and with a highly elevated cdt, confirming their health status objectively, may be contraindicated for a sustained calorie restriction program without nutritional guidance. although the literature is rich in studies suggesting that calorie restriction improves lifespan and reduces inflammatory markers, emerging studies emphasize that calorie restriction must be implemented without malnutrition that comes from low nutrient-dense foods processed foods. macro-and micronutrient intake of all participants was monitored with a food journal. worsening in cdt markers in people on a calorie-restricted diet correlated to micronutrient malnutrition exacerbated by reduced total calorie intake. malnutrition status was established in these individuals by determining their daily nutrient recommendation from the dri calculator for healthcare professionals provided by the usda and comparing the results to nutrients consumed based on available nutritional labels for foods consumed. there are numerous studies on the association between lifestyle behaviors and chronic disease risk. in large prospective studies, like the nurses' health study, vague conclusions are made about the association of smoking, regular physical activity, maintaining normal body mass index, eating a healthy diet and chronic disease proliferation [ ] . the individualized cda risk values potentially increase the precision, personalization, and accuracy of risk-to-disease relationship measurement. figure provides a view of the change in the cda risk score and its relationship to the cdt value for the biomarker panel at the beginning and end of the -month hrp program for the entire population. the same data are presented in figure as bubble chart with the before and after data superimposed on the same scale. temperature score) before and after six months of the hrp program notable is the reasonably smooth relationship between the two risks scores, the subjective cda and the more objective cdt. we conclude, from these data, reducing the most basic health risks, over time, may lead to a reduction in cytokine burden with often concomitant change in diagnosed chronic diseases. increasing the "n" in our database and making appropriate adjustments to assigned subjective risk values within the algorithm offers the potential to improve the correlation between determinants of health risks and physiological health status. the individualized statistics for the cda, cdt, and biomarkers comprising the cdt to evaluate participants health and risk are provided in table . score mean before mean after mean difference standard deviation t test value cdt is the chronic disease temperature biomarker score as a relative value with . considered optimal and elevated values indicating chronic risk; hba c is expressed as a %; glucose is expressed as mg/dl; nlr is the neutrophil to lymphocyte ratio; hs-crp is high sensitivity c-reactive protein or c-reactive protein, cardiac expressed as mg/l; insulin is expressed as uiu/ml; hdl is expressed as mg/dl; triglycerides are expressed as mg/dl; vitamin d is expressed as ng/ml; uric acid is expressed as mg/dl; wbc is the white blood cell count expressed as cells/ul; rdw is the red blood cell distribution width expresses as a %; ab neutrophils are neutrophils (absolute) expressed as cells/ul; esr is the sedimentation rate-westergren expressed in mm/hr; fibrinogen is fibrinogen activity expressed as mg/dl; homocysteine is expressed as umol/l; and aip is the atherogenic index of plasma expressed as the log(triglycerides/hdl) glycosylated hemoglobin (a c): a c, a -day retrospective average of blood glucose, contributes to an assessment of metabolic risk along with fasting glucose and insulin. a current therapeutic goal in usual care is to lower the a c value of diabetics, those with a c values above . %, with pharmaceuticals. the accord study shows that tight pharmaceutical control of blood sugar in those with severe insulin resistance suffer a significant increase in adverse cardiovascular events and mortality compared to those with less tight control [ ] . lifestyle interventions offer another approach to glycemic control and does so without risk of hypoglycemia and other side effects of the pharmaceutical approach. in the cohort of , none had optimal a c levels, defined as . %- . %. even a . % increase in a c above % increases the year risk for diabetes (odds ratio > . ) and the risk of diabetes increases exponentially with a c. in the participant cohort, at the end of the hrp, % (all but ) lowered their a c value ( insulin is the most sensitive marker for early metabolic risk because it increases first as an individual becomes insulin resistant. even values slightly above normal, and well below a diagnosis of diabetes, contribute to serious chronic diseases in the future, including alzheimer's and cardiovascular disease. type diabetes is associated with increased risk of cancer. hyperinsulinemia (elevated insulin levels) and insulin resistance are apparently the link. in a -year mortality study, individuals in the highest quintile of serum insulin had a % higher risk of cancer mortality and a % higher risk of gastrointestinal cancer mortality [ ] . the authors of this study concluded that hyperinsulinemia/insulin resistance is associated with cancer mortality independently of diabetes, obesity/visceral obesity and metabolic syndrome. in the -person cohort, participants ( %) were at elevated metabolic and associated chronic risk. six of the ( %) experienced a double digit drop in fasting insulin, of ( %) dropped from the high-risk category to a lower risk level, ( %) lowered insulin levels sufficiently to reduce their cancer risk severity category, ( %) changed little and stayed in the same risk category and move up one risk category ( [ ] . in the -person cohort, % of participants who were at high risk for cardiovascular disease, based on hs-crp level > , lowered that risk ( table ) . [ ] . the aip average value before the hrp was . and lowered to . at the end of the hrp. conventionally the rdw test, which is a part of a complete blood count, is used to help determine anemia status. however, it is also a marker of inflammation and often tracks with crp. red blood cells elongate and deform when flowing through capillaries, which may explain the association between red blood cell widths, vascular inflammation, and increased cardiovascular morbidity and mortality. in the -person cohort, % of participants at elevated risk for cardiovascular disease based on rdw levels lowered their risk ( table ) . white blood cell counts (wbc) is a predictor of strokes, heart attacks, and fatal heart disease. in the women's health initiative involving , women from - years of age, those with approximately , white cells per ml had more than double the risk of fatal heart disease than women with cells per ml [ ] . white blood cell counts in the normal range for acute indications are now more widely recognized as a predictor of adverse chronic outcomes. in the -person cohort, three individuals had high cardiovascular disease risk based on wbc levels, and % lowered that risk through lifestyle modifications. in addition, % of those with moderate risk moved to either low or very low risk as assessed by risk quartiles for wbc. in general, % of participants moved from a high to a lower risk status ( table ) . multiple studies show a significant inverse relationship between -hydroxy vitamin d (d ) status and cancer mortality. in a fifteen-year study of nearly , participants, an increment increase of ng/ml was associated with a % reduction in total cancer incidence, % reduction in total cancer mortality and statistically significant reductions in colorectal, pancreatic, esophageal, oral, and pharyngeal cancer mortality [ ] . for cancer, optimal d levels are above ng/ml. at the start of the program, eight participants had optimal levels and that number increased to by the end of the program. insufficient vitamin d, as defined for bone health are values below ng/ml. initially there were participants insufficient for blood d and none were insufficient at the end of the program. the population d levels went from to ng/ml, on average, by the end of the hrp. these data indicate a high degree of compliance with the program recommendations as the increase in d status was largely attributable to consistent supplementation. in general, the increase observed required daily supplementation of iu d daily ( table ). the neutrophil-to-lymphocyte ratio (nlr) is reported to be a robust outcome prognosticator in existing solid tumor cancers. in a study on breast cancer, patients with an nlr > . had substantially higher oneyear and five-year mortality rates compared to those with an nlr < . . the nlr value has similar predictive ability for cardiovascular mortality [ ] . in the cohort of , had nlr above the threshold for adverse cancer outcomes. sixteen of ( %) saw their nlr ratios return to very low risk (normal values) by the end of the program ( and associated changes to cancer and cardiovascular mortality prognosis medication prescription reduction was achieved as part of the outcome measurement. the cohort experienced a % reduction in medication usage, reduction in dose in %, and an avoidance of two costly medications. the prices included in table , below, where the actual pharmacy costs realized by the health plan and did not include any co-pay. the cohort experienced a reduction in chronic disease burden. chronic disease reduction was determined by changes in any of the following: actual change to a medical diagnosis, elimination of a medication associated with an existing diagnosis, changes in a vital sign that indicated a migration out of a diagnosis that was affected without the use of a medication, or change in a biomarker value or values that were initially used to make the diagnosis into a "normal" range without the use of medications (table ) . this participant presented with major risk factors and complaints including lack or exercise, fast food diet, high carbohydrate diet, daily high fructose corn syrup containing beverage consumption, use of omega- containing oils in cooking, statin drug daily prescription for primary cardiac event prevention, severe arthritis, psoriasis, and cataract. the severity of the psoriasis and her job function put her at risk of imminently going on disability. she had seen multiple specialists, was placed on antihistamines and topical steroids but her psoriasis condition continued to worsen. the next treatment option for her was to be etanercept which she declined pending the outcome from the hrp. she indicated that she had not washed her hands without pain in over a year. the hrp included -minute semi-monthly health revival coaching following the participant and care team agreed upon care plan. cholesterol-lowering drug usage was eliminated in the first month as directed by our medical director. health coaching focused mainly on food substitutions, increasing activity, value and use of supplements, a limited set of supplements, and additional care to her oral hygiene. after six months of intensive health revival coaching, many risk factors and complaints, revealed on her cda report, were either removed or reduced including nagging chronic pain. her main complaint, debilitating psoriasis slowly, but completed resolved in five months ( figure ) . however, the first signs of improvement in her psoriasis condition did not appear until month of the program. normally, in the case of autoimmune diseases like psoriasis, food sensitivities or allergies must be addressed. this participant was unwilling to eliminate some of the common allergens like gluten and dairy. she was placed on a modest supplement regiment based on nutritional deficiencies determined from food journaling, including: cod liver oil ( g/day); vitamin d ( , iu/day) and a multivitamin/mineral supplement (taken per label instruction), and the other general supplements included in the "methods" section. positive changes in lab values included: -hydroxy vitamin d status ( to ng/ml); white blood cell counts ( , to , ) ; rdw ( . % to . %); and fibrinogen ( to mg/dl). case : rheumatoid arthritis and type diabetes - -year-old male factory worker with a high school education (table ) . over the first five months, the participant lost pounds through a reduction in carbohydrate consumption, but with no significant change in daily calorie intake. the participant embarked on a substitution diet where, over five months, gluten-containing foods were removed from his diet and replaced with vegetables and marine-and animal-based fats. he was also put on a modest supplementation program including cod liver oil ( g/day); vitamin d ( iu/day); magnesium glycinate ( mg/day); vitamin k ( mcg/day) and a multivitamin/mineral (per label instruction). his type diabetes was reversed as illustrated by his a c dropping from . % to . % and his fasting glucose dropping from to < mg/dl. his pain was substantially eliminated, based on a subjective pain score of / initially, to / . his ra improved to enable him to be able to bend his fingers into a full fist for the first time in over five years (figure ). this participant reported with a severe autoimmune disease, polychondritis, that produced monthly painful flares in cartilage above her shoulders including her ears and eyes. long-term use of steroidal antiinflammatories were implicated in the cataracts and a breast lump that was removed surgically. the cataracts had progressed sufficiently to cause her to be on disability and be unable to drive a car. cataract surgery was not an option due to the severity and unpredictability of eye flares that could cause extremely adverse outcomes if they coincided with surgery. she had seen several specialists including local rheumatologists, natural doctors, and doctors from cleveland clinic with no relief to her condition. she had researched polychondritis on her own, prior to joining this program and eliminated gluten and dairy from her diet but this change did not alter the disease severity or frequency. this participant had made significant changes in her lifestyle prior to this program as reflected in her cda grade, but these changes were insufficient to improve her blood biomarkers indicated by the high cdt value of . , indicative of serious health risk and poor prognosis. our health revival process guided her to continued better choices and involved semi-monthly -minute lifestyle coaching. the main changes made over a six-month period included: increasing healthy fats, reducing carbohydrate intake, increasing micronutrient density, stopping nicotine dependence, improving digestive health with optimizing food choices including increasing stomach acid status, and repopulating gut microflora. at month in the program, her eye and ear flares had subsided sufficiently to allow for a meaningful reduction in eye and oral steroids, ( mg/day to mg/day prednisone). in addition, she was able to have successful cataract surgery which enable her to start driving again, and return to work, both of which were curtailed over one year. the polychondritis may never be cured, however, with appropriate lifestyle management, it is no longer impacting her quality of life. prevention and reversal of chronic and non-communicable diseases continue to be a largely unmet need. a fresh approach is clearly warranted to curb this global scourge. one impediment is the lack of precision and personalization of risk with "poor diet" as an example. and there is a lack of measurement of a broad array of minor, yet important, risks that can easily be overcome. the same suite of risks is continually presented to individuals who historically have not been able to modify or overcome them, with smoking or alcohol consumption as examples. according to khullar in, "we're bad at evaluating risk, how doctors can help," a broader approach involves helping patients systematically identify what's important to them, and based on these goals and preferences, suggesting to them how to think about their options [ ] . this logic is best applied across the entire time-line that defines the slow and insidious development of chronic disease. it starts with lifestyle decisions and habit development early in life that perpetuate into mid-life and then into old age. measurement and a proper medical "workup" regardless of presumed health status is a key strategy and potential motivating factor that is currently lacking. changes in chronic disease biomarkers in asymptomatic people may afford an early warning sign of stealth changes to which many may respond. pathology changes, identified with advanced diagnostics, which generally develop after a long incubation period detectable with proper biomarker evaluation, may facilitate change in the more recalcitrant. each individual has their own motivations. thus, providing patients with an array of choices and recommendations along the health/disease continuum has a higher probability of inciting action and improving outcomes or preventative actions. this study evaluated a new population risk and health assessment and mitigation system where measurements of risk and disease were made across the disease continuum by using finely tuned biomarkers and risk assessment. the output was a broad-reaching care plan assembled through integration of current health survey results, biomarkers, problems, complaints, medications, vital signs, verbal input from the participant to the health coach, and contributions from the care team. the remediation path to improved health developed as a consensus between the participant and care team, of agreed upon steps and actions, that were malleable as the process moved forward. adjustments were made based on participant preferences, success and failures, a solid health data. according to khullar, "patients need to understand their values but also their possible futures. the idea is not to reduce uncertainty, but to help patients clearly envision what life would look like in one outcome versus another, and to better prepare them for the various futures that might unfold." this program was designed to give participants options beyond the management of disease once it has struck. and it included regular monitoring and concomitant course adjustments to help participants attain their goals. this study prospectively observed adults with chronic conditions and unresolved health complaints that remained unresolved under usual care management and treatment. following six months of hrp, participants achieved subjective and objective improvement in health status with % seeing a reduction in multiple blood-based biomarkers and % achieving a reduction is a broad measure of determinants of health risk factors. concurrently participants reported weight loss ( % of the total and % of those with a reported weight loss goal), reduction in reported pain, sleeplessness, memory issues, heartburn, skin rashes, migraines, and daily fatigue. the diabetics in the program had all progressively worsen over the previous two years, as measured by fasting glucose, hba c, and medication usage and all improved under the hrp program. hrp meaningfully improved hba c, fasting insulin, neutrophil-to-lymphocyte ratio, hs-crp, vitamin d, white blood cell counts, red blood cell distribution width, absolute neutrophils -all part of the cdt panel. in addition, hdl, fasting glucose, triglycerides, gfr, atherogenic index of plasma (aip) liver enzymes, and blood pressure improved is most participants with initial abnormal values. aip is emerging as a valuable representation of increased mortality risk. improvement in this lab value ratio was consistent with previous studies using carbohydrate-restricted interventions. however, although the hrp included some level of carbohydrate restriction, this was not a mandate and carbohydrate consumption goals were not set. instead, participants were afforded broader options that met each at their level of readiness to change and did not overwhelm anyone with unachievable objectives. in general, small swap-out suggestions were agreed upon at each encounter. the "pure" study reports are a set of studies that describe components of the nutritional approach used in the hrp. in "fruit, vegetable, and legume intake, and cardiovascular disease and deaths in countries (pure): a prospective cohort study," fruit, vegetable and legume consumption recommendations were - g/day to achieve maximum benefit at reducing non-cardiovascular and total mortality [ ] . the hrp coaches encouraged consumption of three to four servings of these foods per day, focusing on lowest glycemic index choices. in "associations of fats and carbohydrate intake with cardiovascular disease and mortality in countries from five continents (pure): a prospective cohort study," healthy fats were found to be indicated for a reduction of total mortality risk and saturated fats were shown to be inversely associated to stroke risk. the hrp coaches guided participants to swap out carbs, sugars, and some protein in favor of healthy fats in foods and cooking oils with emphasis on increasing saturated, mono-saturated, and marine fats. obtaining nutritional ketosis for a two to three months window was suggested for all the diagnosed type diabetics; however, none achieved sustained ketosis but their metabolic markers indicated improvement of their diabetic conditions during the -month hrp. this suggested that the broader, more personalized risk reduction approach of this hrp, compared to strict carbohydrate restriction, affords metabolic profile results without the potential risks associated with carbohydrate starvation in insulinresistant subjects. reducing whole body inflammation was the primary objective of each encounter, not just reducing the glycemic value of food. examples included switching out proinflammatory for anti-inflammatory cooking oils, lowering glycemic value and load of substituted foods, reducing frequency of fast food consumption, improving oral hygiene, managing stress, establishing better sleep and rest patterns, enhancing hydration, improving micronutrient density of foods consumed, establishing more frequent movement routines, and consuming more gut-supporting foods. the regular health coach encounters that included reviewing risk factors, vitals, and medication usage, with doctor supervision, may have provided behavior reinforcement. further, it is plausible that this multi-risk amelioration care model allowed from both broader and greater adoption and improvements compared to interventions focused on fewer factors. in this hrp we effectively leveraged credible measurement and evaluation, linked these findings to participant's unresolved and nagging health complaints, and facilitated behavioral change leading to health improvement in most participants. the program did not rely only on usual care measures of health. participants were not confronted with high hurdles to health improvement that often discourage engagement. instead, the program centered around meeting a person at their level of readiness and capitalizing on small triumphs that eventually led to measurable health improvements recognized by the individual that led to a cycle of improvement rather than deterioration. no episodes of adverse events were attributable to the hrp. one insulin-dependent type diabetic participant showed a sudden increase in fasting insulin, from . to μu/ml, which was reported to his pcp for medication adjustment. several participants reported dizziness and either the hrp or pcp lowered their blood pressure medication dose that, in all cases, resolved the complaint. prior studies have demonstrated favorable cost reductions in broad-based wellness and disease management programs. most of the cost-saving and health maintenance were attributed to the management of existing disease rather than prevention and required a strong evidence-based approach. a strength of this hrp was an emphasis on root-causes of and reversal of disease rather than just case management. additionally, this study reflected a real-world workplace environment with a distribution of both white-and blue-collar workers participating and with a range of diseases and aliments. weaknesses included a lack of a representative control group, single location and participants were mostly caucasian. the study was not of sufficient size and duration to measure hard endpoints including mortality and adverse health events. future studies of this nature could include multisite randomized controlled trials with greater racial and ethnic diversity, and longer duration. this highly personalized and scalable health revival study protocol demonstrated that a broad array of chronic health complaints and problems can be controlled and reversed by methodically eliminating seemingly small lifestyle-induced health risks. it also demonstrated that the lifestyle risk tool, the chronic disease assessment™, and the biomarker panel, the chronic disease temperature™, that were used to develop care plans, changed in correspondence with participant-and medical staff-reported health improvements. therefore, these tools may be valuable for the measurement and mitigation of chronic disease risk and chronic diseases generally. importantly, the implementation of this program is low cost, using inexpensive on-line survey tools, biomarkers, and health coaching. additionally, this program is well suited to be implemented in large populations through surveying, obtaining labs through national networks, and performing group coaching sessions based on common risks identified through the risk assessment tool. more studies using this overall hrp approach are required to validate the measurement methods, processes, and outcomes. this approach offers a potentially important health delivery modality in a world with escalating chronic disease morbidity and mortality. acquired in strict conformance with health data privacy laws by medical personnel and stored and managed in a hipaa compliant emr. animal subjects: all authors have confirmed that this study did not involve animal subjects or tissue. conflicts of interest: in compliance with the icmje uniform disclosure form, all authors declare the following: payment/services info: all authors have declared that no financial support was received from any organization for the submitted work. financial relationships: all authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. other relationships: all authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. global status report on noncommunicable diseases. world health organization (ed): world health organization the us health disadvantage relative to other high-income countries: findings from a national research council/ institute of medicine report heart disease strikes back across the u.s even in healthy places multiple chronic conditions in the united states consistently high turnover in the group of top health care spenders the cytokine storm and pre-cytokine storm status in covid- -a model for managing population risk for pandemics and chronic diseases association between platelet parameters and mortality in coronavirus disease : retrospective cohort study. platelets. disease control priorities in developing countries. nd edition. the international bank for reconstruction and development/the world bank global, regional, and national comparative risk assessment of behavioural, environmental and occupational, and metabolic risks or clusters of risks, - : a systematic analysis for the global burden of disease study effects of health literacy on health status and health service utilization amongst the elderly is patient activation associated with future health outcomes and healthcare utilization among patients with diabetes lipid levels in patients hospitalized with coronary artery disease: an analysis of , hospitalizations in get with the guidelines use of framingham risk score and new biomarkers to predict cardiovascular mortality in older people: population based observational cohort study stress and the individual: mechanisms leading to disease . arch internal med network theory of aging meeting physical activity guidelines is associated with lower allostatic load and inflammation in mexican americans multiple biomarkers for the prediction of first major cardiovascular events and death atherogenic index of plasma and triglyceride/high-density lipoprotein cholesterol ratio predict mortality risk better than individual cholesterol risk factors, among an older adult population quarterback your own health -how to take and lower your chronic disease temperature acute-phase proteins and other systemic responses to inflammation diet, lifestyle, biomarkers, genetic factors, and risk of cardiovascular disease in the nurses' health studies the association between symptomatic, severe hypoglycaemia and mortality in type diabetes: retrospective epidemiological analysis of the accord study insulin resistance/hyperinsulinemia and cancer mortality: the cremona study at the th year of follow-up rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity c-reactive protein: rationale and design of the jupiter trial leukocyte count as a predictor of cardiovascular events and mortality in postmenopausal women: the women's health initiative observational study prospective study of predictors of vitamin d status and cancer incidence and mortality in men the predictive value of elevated neutrophil to lymphocyte ratio for long-term cardiovascular mortality in peripheral arterial occlusive disease we're bad at evaluating risk. how doctors can help . the new york times fruit, vegetable, and legume intake, and cardiovascular disease and deaths in countries (pure): a prospective cohort study the authors thank the invaluable assistance of dr. michael l. carter, dr. trent austin, and jasmin lewis human subjects: consent was obtained by all participants in this study. neco irb issued approval t.the neco irb has approved this study as it was conducted in conjunction with routine clinical practice. all procedures performed in the program involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the helsinki declaration and its later amendments or comparable ethical standards. ethical oversight was provided by the existing primary care doctors who were not part of the program. informed consent, medical releases, and participation contracts were obtained from all participants included in the program. these documents were completed after each participant was provided detailed information about the program. all data was key: cord- -cf mn pu authors: o'keeffe, dara ann; bradley, dorothy; evans, linda; bustamante, nirma; timmel, matthew; akkineni, roopa; mulloy, deborah; goralnick, eric; pozner, charles title: ebola emergency preparedness: simulation training for frontline health care professionals date: - - journal: mededportal : the journal of teaching and learning resources doi: . /mep_ - . sha: doc_id: cord_uid: cf mn pu introduction: at brigham and women's hospital, we identified the need for a comprehensive training program designed to prepare frontline staff to safely manage a patient with ebola viral disease (evd). the primary goal of this program was to ensure the safety of staff, patients, and the general public by training staff in the correct use of personal protective equipment (ppe) before, during, and after care of patients with evd. methods: we delivered a -hour experiential training program to frontline health care professionals who would be expected to care for a patient with evd. the program occurred in a simulation center with multiple flexible spaces and consisted of demonstration, multiple skills practice sessions, and a patient simulation case. we analyzed completed pre- and posttraining questionnaires. the questionnaire assessed their subjective level of confidence in three key areas: donning and doffing ppe, performing clinical skills while wearing ppe, and management of a contamination breach. results: this program was effectively deployed in the stratus center for medical simulation over a -month period, with health care professionals participating in the training and participants completing the pre-/posttraining questionnaires. our intervention significantly increased the confidence of participants on each primary objective (p = . for all three stations). discussion: this interprofessional simulation-based program has been shown to be a well-received method of training clinicians to manage patients collaboratively during an evd outbreak. our intent is that the skills taught in this training program would also be transferable to management of other infectious diseases in the clinical setting. training staff in the correct use of personal protective equipment (ppe). many hospital-wide drills and training sessions were implemented in response to the recent ebola epidemic. here, we describe a simulation laboratory-based program that was used as the foundation training for frontline staff in the correct use of ppe for clinical care activities. epidemics have challenged human existence for millennia. there is evidence of widespread infectious outbreaks as early as bce in ancient greece. in recent history, severe acute respiratory syndrome in the early s and h n influenza in resulted in significant worldwide morbidity and mortality. the medical community is now confronting two recent epidemics, the current west african evd outbreak that began in and, since , an outbreak of middle eastern respiratory syndrome in south korea and china for which the world health organization reports , laboratory-confirmed cases, including at least related deaths. all of these events have stressed the need for greater investment in building resilient systems to prepare for, respond to, and recover from emerging infectious disease epidemics. for nearly years, simulation-based education has proven to be an integral part of medical training. since the early work of small et al., numerous studies have shown simulation-based education's invaluable contribution to the refinement of team structure, communication, and procedural skills. due to its emphasis on patient and staff safety, it has become an invaluable adjunct to traditional methods of teaching and training, especially in residency programs. since the s, simulation has been used in epidemic response training. programs now include disaster exercises, semester-long courses for professional students, web-based simulation exercises, and large-scale high-fidelity curricula that utilize human simulators and actors. preparing for a response to an emerging infectious disease includes not only the conventional factors that characterize other disasters but also the need to become efficient in using clinical and procedural skills while wearing protective gear that has the potential to hinder flexibility, dexterity, and communication. simulation education provides a seamless stage for this type of training. at the neil and elise wallace stratus center for medical simulation and the center for nursing excellence at bwh, we have extensive experience in the simulation of many clinical events and skills across multiple disciplines. we consistently conduct interprofessional team and skills training sessions and have a team that frequently creates curricula for these programs. the overall goal of this program is to teach and enable practice of the appropriate donning and doffing of ppe according to accepted protocols and to teach the management of biosafety level waste. the skills practiced will enable participants to perform or assist in the performance of standard clinical skills while wearing appropriate ppe. due to the austere nature of the clinical environment, this program is intended to be interprofessional. it is intended to enable and encourage collaborative care by providers who will need to participate in activities not typically required of them in less restrictive environments. as the primary goal of this course is to facilitate familiarity with the use and functionality of specific equipment and implementation of specific step-by-step processes, the most suitable instructional format is deliberate practice in a simulated environment. this program requires space to meet the needs of at least participants rotating through multiple stations, some of which run concurrently. the participants will actively don and doff ppe, learn and practice the management of biosafety level hazardous waste, and be provided an opportunity to manage, in interprofessional groups, a variety of routine medical processes and procedures while wearing ppe. participants should be hospital clinicians who have the potential to be exposed to and care for patients with evd in an isolated environment. these would include physicians, nurses, physician assistants, respiratory therapists, phlebotomists, and other relevant health care workers. the curriculum described hereafter is a -hour fundamental interprofessional training course designed for potential evd caregivers. the course consists of a concise didactic session and observation of a demonstration of donning/doffing evd-required ppe, active participation in the donning/doffing of ppe, course outline a concise schedule outlining the time and basic requirements for each section of the course is contained in appendix a. introduction of donning and doffing ppe setup: arrange table and chairs conference-style to enhance introductions, observation, debriefing, and evaluation processes. assign seating prior to class by placing nameplates with roles and designated groups around the table to ensure learning groups are interdisciplinary and to enhance conversations from the beginning of class. have a computer with audiovisual capabilities on hand, as well as adequate space for the demonstration of donning and doffing of ppe using an observer and a separate narrator. give each participant a precourse survey prior to the start of the class. participants and faculty introduce themselves, providing their name, institutional role, and personal expectations for the program. center layout and amenities are introduced. full attention of participants is requested, and a request to turn off beepers and telephones is made. the expectation that participants will stay for the complete -hour training is stated as is a short description of ground rules for the course: the management of patients with evd is evolutionary in nature. protocols will therefore be iterative. the training session is not the only training that people will be receiving, and a description of subsequent opportunities should thus be presented. up-to-date protocols are being taught as recognized by the institution, and participants are asked to delay specific questions concerning the protocols until they are actively participating in the don/doff exercise or until the end of the program. clarification regarding the purpose of the program is reinforced: except for safe donning and doffing and waste-management skills, no new clinical skills will be taught today; this is an opportunity to practice a variety of already-known skills while wearing ppe. the environment in which the ppe is worn will necessitate enhanced teamwork. as there is little chance of getting extra help expeditiously, a willingness to participate in patient care skills outside the normal realm of practice will be required. however, at no time will caregivers be asked to perform any skill outside their scope of practice. the schedule is explained. psychological safety of the simulation learning environment is ensured by guidelines for active participation, engagement, respect for fellow participants, and confidentiality (as per the simulation center's usual practice). three faculty members are required: a narrator, a clinician, and a safety monitor (third-party trained observer). obtain all necessary ppe. introduce participants to the don/doff checklist and required processes. a narrator briefly shows and explains each piece of equipment (participants are asked to hold questions until they move to the practice station). the narrator reads the checklist sequentially as the safety monitor assists the clinician in the donning/doffing procedure. provide space(s) for three teams to don and doff ppe. all donning and doffing accessories (chlorine-based wipes, armless stationary stool, ppe equipment, and waste containers) should be available. two faculty members are assigned to each group: one to serve as the checklist narrator and one to serve in the role of evd safety monitor responsible for assisting clinicians with the safe donning/doffing of ppe. the narrator reads the checklist slowly and methodically. the safety monitor assists participants in the active exercise of donning/doffing ppe. appendix b contains detailed checklists for donning and doffing ppe. note that these checklists were developed based on the bwh protocol for ebola management. some variations may exist at different institutions. three individual spaces with supplies specific to each are needed. see appendix c for a more detailed description of the equipment required for each station. two faculty members are needed at each station to assist in learning activities. individual requirements of the three stations follow. station a station a covers airway management, dressing care, iv infusion management, and urinary catheter care (± additional basic skills as required). airway management substation: a mannequin should be placed on a table or in bed wearing a nonrebreathing mask and must be able to be ventilated with a bag-mask ventilator and intubated orally, as well as having an iv arm with a crystalloid infusion for drug administration. ideally, the mannequin is attached to a pulse oximeter and cardiac monitor that can be manipulated to represent a desaturating patient; however, this is not necessary. also present should be airway equipment and medications (vials, prefilled syringes, alcohol wipes, and needles/infusion systems) that are typically employed in airway management at the institutions in which the participants practice. there should also be appropriate waste-disposal equipment. dressing care and iv infusion management substation: the mannequin can be medium or low fidelity on a table or a bed and have a dressing taped to an area of the skin. it should have an iv arm with a primary iv set infusing saline through an infusion pump. a -mg infusion of magnesium sulphate with appropriate accessories for piggybacking the infusion should be available. a dressing and tape should be available as well. there should also be appropriate waste-disposal equipment. urinary catheter care substation: on a table or bed, there must be a mannequin or task trainer in which a urinary catheter can be placed. urine should be in the bladder. a urinary catheter, a catheterization start kit, and a drainage bag should be available. there should also be appropriate waste-disposal equipment. for each of the stations above, interprofessional groups of three to four learners will perform the routine clinical care tasks set up in the station. each participant should perform tasks appropriate to his/her discipline and training, but all will practice assisting each other, as mastering communication and dexterity while wearing the ppe is a core learning objective of station a. setup: this station should be equipped with mops, solutions, appliances, waste bins, and waste bags that will be employed in the management of biosafety level waste within the institutions in which the participants practice content: see appendix d for detailed content. station c station c features human patient simulation. equipment/environment: a medium-to high-fidelity mannequin is dressed in hospital garb and is laying at ° in a bed with a blanket covering it. the mannequin is not initially attached to the cardiac monitor or pulse oximeter. the mannequin will have a urinary catheter with a drainage bag that has ml of fluid simulating urine hanging off the side of the bed. the mannequin will be placed on typical hospital linens with an absorbable underpad that has material simulating stool on the pad. equipment to initiate and secure a peripheral iv and an iv infusion pump with which to initiate the iv infusion must be present. the rest of the room should appear as a patient isolation room. personnel: the simulation specialist runs the mannequin. one faculty member is the patient's voice via microphone from a control room. as this is a low-acuity scenario, one faculty member should suffice to both perform as the patient and observe for later debriefing. however, if a second faculty member is available to be the observer/debriefer, that would be of additional benefit. no confederates are required in the room. assessment: the participants are observed for their communication with the patient and with their colleague in the room and for their performance of simple clinical tasks, such as attaching the patient to monitors, cleaning the soiled patient, and disposing of the soiled materials in the correct way. faculty may choose to add additional tasks to the scenario such as insertion of an iv line or managing a fluid spill on the ground. faculty may refer to the protocols for such tasks included in this publication or reference their own protocols or checklists for specific tasks from their institution. however, the principle learning objective is that participants are able to perform already-known tasks within the confines of the ppe and that all procedures for infection control are strictly adhered to. donning and doffing the ppe may also be included as part of the scenario or as a separate station depending on the time available. debriefing: the debriefing consists mostly of a facilitated discussion by participants on what the expected and unexpected consequences of having the ppe in place were on their ability to perform basic patient care tasks. faculty identify errors or lapses in protocol that they observed and ask participants to outline what they feel contributed to those incidents. patterns and difficulties with communication should also be debriefed, with an emphasis on how the team performed given the constraints of the environment and the ppe. we did not use video playback in our debriefing session as time was limited and not all of the interprofessional faculty were familiar with our video playback software. however, it should be considered a valuable addition to the debriefing session if available and if faculty are trained in its use. see appendix e for full details of the simulated patient scenario's setup, content, and debrief. final doffing at the conclusion of the final skills station for each participant, final doffing of ppe takes place. setup requires ample room marked by tape to mimic both a hot zone and a warm zone. appropriate doffing accessories (chlorine-based wipes, armless stationary stool, waste containers, and receptacle for ppe) should be available in the room. see appendix c for a more detailed description of the equipment required. appendix b contains the doffing checklist. this program was effectively deployed in the stratus center for medical simulation over a -month period in - . participants in our -hour program included physicians, nurses, respiratory therapists, laboratory technicians, and ancillary staff. two-hundred and twenty health care professionals participated in the training. all were asked to complete the same three-question survey before and after participation in the training program. the survey assessed their subjective level of confidence in three key areas: management of a contamination breach, performing clinical skills while wearing ppe, and donning and doffing ppe. these questions were answered using a -point likert scale with the anchors not at all confident and extremely confident. replies were converted to their numerical value on the likert scale, and a one-way analysis of variance was performed to calculate the p value. we analyzed completed pre-and posttraining questionnaires from participants. prior to participating in the program, %, %, and % of participants rated their confidence level as not at all confident or a little bit confident in management of a contamination breach, performance of clinical skills in ppe, and donning and doffing, respectively. after completing the course, %, %, and % of participants rated their confidence as to some extent, quite a bit, or extremely confident (figure ). our intervention significantly increased the confidence of participants on each primary objective (p = . for all three stations). means and p values for confidence scores in each station are presented in table . overall, % of participants rated the quality of the simulation on the program as good or outstanding, and % rated the faculty as good or outstanding. these results are outlined in figure . this program was successfully deployed and well received by the health care professionals in our institution. as it was a newly designed program for our center, there were many lessons learned along the way. we concede that the design of the program is faculty intensive. however, it was important to have a high faculty-to-participant ratio in order to replicate the high level of supervision that occurs when monitors supervise donning and doffing techniques in the clinical setting. potentially, faculty requirements could be reduced by using core teaching faculty in the monitor role in the one-to-one donning and doffing sessions. participants could also perform this role, provided they were instructed in the monitoring process in advance. we utilized a high-fidelity simulation environment for our simulated patient experience station, but most of the course objectives could be achieved in a lower-resource setting by omitting this station if the facilities are not available. the -hour program length was necessary to allow for repeated practice of a very complex donning and doffing process with many specific steps to complete. one difficulty we encountered was the continuously evolving protocols for ppe. protocols were revised as newer equipment was received, limited by a challenged supply chain as demand outweighed supply from numerous vendors from october until february . for example, based on drills and exercises, we converted from one respirator brand to another that provided clearer communication and improved cooling. these protocols may vary between institutions and may be revised and altered within single institutions over time. it is important that centers implementing this course establish what the local protocols for ppe use are and adhere to them in order for the training to be applicable to the health care professionals in that institution. at the same time, we also encourage institutions to follow nationally and internationally accepted protocols as closely as possible. while we have solicited and analyzed feedback from a large number of participants, one of the questions in our survey referred to a skill not directly covered in the training. when originally designing our program, we hoped to include full training on management of a breach. however, it was felt that this was a higherlevel training objective, more suited to the monitors (trained clinical observers), and therefore, this content was removed from the course. our participants were instructed that if a suspected breach occurred, they would be directed by their trained observer. we decided to leave this question in our feedback survey and found that confidence was increased in this area. we feel this represented a level of confidence in the system of donning and doffing in pairs with an observer guiding. also, we have not evaluated durability of the training by assessing long-term retention of the skills we trained for. ideally, implementation of this program should include shorter sessions of follow-up training at regular intervals. no clear guidance for frequency and modality of training for health care workers in this intensive scheme exists, and our models are based on information garnered from national centers of excellence (emory university, the university of nebraska). nongovernmental organizations' national and international efforts should be directed toward outlining standards to define competency, training modalities (functional and tabletop exercises, simulation, web-based training, didactics, etc.), and frequency of those modalities. medicine can look to other industries, including aviation, as the gold standard for competency measurement and evaluation. our interprofessional simulation-based program has been shown to be a well-received method of training clinicians to manage patients collaboratively during an evd outbreak. our intent is that the skills taught in this training program would also be transferable to management of other infectious diseases in the clinical setting. this training should form part of a linear program with subsequent shorter courses at regular intervals aimed at ensuring retention of skills over time. dna examination of ancient dental pulp incriminates typhoid fever as a probable cause of the plague of athens summary of probable sars cases with onset of illness from geographic dependence, surveillance, and origins of the influenza a (h n ) virus demonstration of high-fidelity simulation team training for emergency medicine simulation-based education improves quality of care during cardiac arrest team responses at an academic teaching hospital: a case-control study enhancing patient safety during pediatric sedation: the impact of simulation-based training of nonanesthesiologists for the saem technology in medical education committee and the simulation interest group epidemic simulation for training in public health management investigating an epidemic: a seven-part simulation used in teaching epidemic investigation simulation immersive simulation education: a novel approach to pandemic preparedness and response high-fidelity multifactor emergency preparedness training for patient care providers using a web-based simulation as a problem-based learning experience: perceived and actual performance of undergraduate public health students improving emergency preparedness system readiness through simulation and interprofessional education what a disaster?! assessing utility of simulated disaster exercise and educational process for improving hospital preparedness centers for disease control and prevention web site emergency department processes for the evaluation and management of persons under investigation for ebola virus disease none to report. presented as a poster at the society for academic emergency medicine annual meeting, may . reported as not applicable. key: cord- - a h lo authors: dreyer, nancy a.; reynolds, matthew; defilippo mack, christina; brinkley, emma; petruski-ivleva, natalia; hawaldar, kalyani; toovey, stephen; morris, jonathan title: self-reported symptoms from exposure to covid- provide support to clinical diagnosis, triage and prognosis: an exploratory analysis date: - - journal: travel med infect dis doi: . /j.tmaid. . sha: doc_id: cord_uid: a h lo background: symptomatic covid- is prevalent in the community. we identify factors indicating covid- positivity in non-hospitalized patients and prognosticators of moderate-to-severe disease. methods: appeals conducted in april-june in social media, collaborating medical societies and patient advocacy groups recruited , participants ≥ years who believed they had covid- exposure. volunteers consented on-line and reported height, weight, concomitant illnesses, medication and supplement use, residential, occupational or community covid- exposure, symptoms and symptom severity on a -point scale. of the , curated analytic population , reported a covid- viral test result: positive (covid+) and , negative (covid-). results: the triad of anosmia, ageusia and fever best distinguished covid+ from covid-participants (or . , % ci: . to . ). covid+ subjects with bmi≥ , concomitant respiratory disorders or an organ transplant had increased risk of moderate-to- severe dyspnoea. race and anti-autoimmunity medication did not affect moderate-to-severe dyspnea risk. conclusions: the triad of anosmia, ageusia and fever differentiates covid- . elevated risks of severe symptoms outside the hospital were most evident among the obese and those with pulmonary comorbidity. race and use of medication for autoimmune disease did not predict severe disease. these findings should facilitate rapid covid- diagnosis and triage in settings without testing. trial registration: clinicaltrials.gov nct , eu pas register eupas . limited information is available concerning the symptomatology of human coronavirus disease (covid- ) outside of the hospital [ , ] . here we follow a research model developed in collaboration with the european medicines agency that validated person-generated healthdata as a reliable method for pharmacovigilance [ ] , and use established best practices for patient registries that have been particularly useful in pandemic threats [ , , ] . we build on these models using community-driven research to characterize symptoms indicative of a positive covid- viral test result and identify risk factors for development of serious symptoms of covid- infection outside the hospital setting. respondent-driven sampling in the us from april nd to july th inclusive, yielded , adults who completed registration, demographics and symptoms forms at www.helpstopcovid .com. participants were recruited using social media, with additional awareness raising activities undertaken by medical societies and patient advocacy groups. every state in the us is represented, with most participants coming from populous states with high infection rates: california ( %), new york ( %), florida ( %) and texas ( %). participants provided information about testing and test results; noting that only viral testing was available during this sampling timeframe and most participants reported not having been tested ( %). reported were: covid- -like symptoms using a checklist [ ] and ranked the reported symptoms on a -point severity scale from very mild to severe; comorbidities; presence of fever, use of prescription and non-prescription medication, vitamins and supplements; occupation as well as age, gender and ethnicity. survey respondents were invited to participate in longitudinal follow-up twice a week for four weeks and every two weeks for the following two months. participants were not required to answer every question. no remuneration was provided. a curated analytic data set (n= , ) was created for adults who completed baseline screening of symptoms and demographics, and which excluded likely fabricated entries based on a combination of clinical flags (e.g., body mass index (bmi) < or > , height < ft) and likely duplicates, determined by nearly identical respondent entries within minutes of each other. no missing data were imputed. participants who tested positive (covid+) were compared to those who tested negative (covid-). odds ratios (or) and % confidence interval (ci) were used to estimate the likelihood that a symptom or characteristic (or constellation thereof) would be present given a positive test result. a multivariable logistic regression was used to estimate the or ( %ci) of developing moderate or severe dyspnea among covid+ participants. two models were applied -a reduced model that included demographic characteristics and a full model that added comorbidities and medication use. a total of , participants were included in the curated dataset ( % female; median age years and % non-caucasian), out of which n= , ( %) reported a covid- test result. baseline data are shown for , participants, including covid+ (n= ) and covid-(n= , ). participants reporting a covid- test result had a mean age of years, with % over years of age, and nearly twice as many females as males; % of participants reported education level of "high school or less" (table ) . fever, cough, fatigue and aches and pains were the most commonly reported symptoms, with more symptoms reported on average by covid+ than covid-participants ( . vs . ) ( triad. covid+ participants who reported anosmia or ageusia also had a mean of nine symptoms, in contrast to a mean of just two for those without either symptom. moderate or severe dyspnea was more frequently reported by covid+ ( %) than covid-( %) participants. among covid+ participants the risk of moderate or severe dyspnea did not differ by age, gender, race, or ethnicity. particularly, risk was elevated among the obese (bmi> ) (or . %ci . , . ) and those taking medications for respiratory disorders (or . %ci . , . ). there was no strong evidence of elevated risk for dyspnea among participants with cardiovascular disease or those taking medications for diabetes, hypertension and autoimmune conditions (table ) . this research program is unusual in its evaluation of symptomatology for covid- in the community setting [ ] and may be particularly helpful in a number of travel medicine related settings, e.g. on board cruise ships and in other maritime settings, including naval vessels; during military deployments and in remote or resource poor settings [ , , , , ] . anosmia and ageusia were the most likely symptoms indicative of a positive test results, and participants reporting either of these had more symptoms and of greater severity [ ] . this is in line with previous findings and experimental evidence supporting involvement of the olfactory apparatus [ , ] . the triad of anosmia, ageusia and fever provided a particularly powerful symptom constellation differentiating covid+ from covid-in the community. this triad may offer an expeditious way to identify probable covid- infections in the community, especially in the absence of reliable, widespread testing [ , , ] the triad could be taken as pathognomonic during the pandemic and trigger anti-covid interventions in the absence of reliable nearpatient diagnostics. this may be particularly helpful in many travel medicine or community based settings including resource-poor, logistically challenged or remote settings, as well as in closed community settings e.g. the military, prisons, care homes, seagoing vessels. further support for a clinical diagnosis of covid- might also be a history of vomiting. although nonspecific, vomiting is in general not a feature of respiratory tract infections in the community [ , ] . severe dyspnea is indicative of severe disease that may require hospitalization and may presage possible pulmonary fibrosis or other sequelae [ , , , ] . while our findings are congruent with obesity being a known risk factor for severe disease, the association of significant dyspnea with obesity in a community setting raises concerns about referral thresholds. it may well be prudent to have a very low threshold for referral and admission of symptomatic obese patients. the same consideration could also apply to patients with underlying respiratory disorders. however, there was no evidence for a marked increase in risk among people who reported underlying cancer or cardiovascular disease, or those taking medications for autoimmune disease, diabetes, or hypertension. the absence of increased risk of severe disease in users of medication for auto-immune disorders is similar to previous findings indicating that use of disease modifying agents does not increase the risk of complications from seasonal influenza [ ] . the findings of increased risk of severe disease in the presence of obesity were in line with existing evidence on covid- [ ] and are somewhat in contrast with previous findings in seasonal influenza, which pointed to decreasing risk of influenza complications with increasing bmi [ ] , supporting the distinct pathology and immunopathology of covid- . our findings would be strengthened by complementary analyses of other clinical and treatment information for obese participants and those on medication for auto-immune disorders, including if and how they are being treated for these underlying conditions; a possible explanation may be that individuals with more severe conditions were underrepresented in our study, but this remains speculative. further validation may be derived from additional data collection and analysis from subsequent waves of infection, a process that has already been initiated. it is important to keep in mind that these data are voluntarily reported, are not a representative sample of the us population, and thus will not support inferences about distribution of symptoms in the us. recognizing that self-reported information has limitations, comparisons between respondents may nevertheless indicate true causal relationships and can serve to stimulate further research as the medical and scientific community seek to learn more j o u r n a l p r e -p r o o f about this infection. this methodology appears to be useful in capturing relevant real world data, particularly symptom severity, without requiring physical presentation for clinical assessment, and offers valuable perspective on the true burden of illness as well as signaling those at particularly high risk of severe symptoms and, in parallel, those unlikely to be at such increased risk. the findings may help guide diagnosis and triage in settings where there is not ready access to rapid and reliable diagnostic testing. approximately - % of participants did not respond to one or more of these questions b n= ( %) of all participants, n= ( . %) of covid+ and n= ( . %) of covid-participants did not provide an answer in this section notes: shortness of breath and severity assessed at baseline. participants who reported shortness of breath, but did not report severity of the symptom were excluded from this analysis (n= ). a referent category includes participants who reported not having the condition of interest or not taking the medication of interest pathophysiology, transmission, diagnosis and treatment of coronarvirus disease (covid- ). a review prevalence of asymptomatic sars-cov- infection. a narrative review direct-to-patient research: piloting a new approach to understanding drug safety during pregnancy recognizing true h n infections in humans during confirmed outbreaks registries for evaluating patient outcomes: a user's guide. conducted under contract no agency for healthcare research and quality investigating outbreaks of novel infectious disease: an international case study real-time tracking of self-reported symptoms to predict potential covid- covid- : travel health and the implications for sub -saharan africa more than coronavirus cases on pacific aircraft carrier, new ones discovered on another carrier in japan: officials coronavirus : plusieurs cas suspects à bord du porte-avions français charles-de-gaulle french aircraft carrier heads home early due to possible covid- cases dolfijn breekt reis af vanwege corona -nieuwsbericht -defensie.nl". defensie.nl olfactory and gustative disorders for the diagnosis of covid- sars-cov- infects and damages the mature and immature olfactory sensory neurons of hamsters van den bruel a. antibody tests for identification of current and past infection with sars-cov- . cochrane database of systematic reviews oseltamivir effectiveness in seasonal influenza patients taking symptomatic therapy: retrospective analysis of rct data clinical features of covid- and influenza: a comparative study on nord franche-comte cluster. microbes and infection long term respiratory complications of covid- pulmonary fibrosis and covid- : the potential role for antifibrotic therapy. the lancet covid- patients with pulmonary fibrotic tissue: clinical pharmacological rational of antifibrotic therapy pulmonary fibrosis secondary to covid- : a call to arms? rheumatoid arthritis and the incidence of influenza and influenza-related complications: a retrospective cohort study single cell sequencing unraveling genetic basis of shared immunologic switch between severe covid and obesity epub ahead of print body mass index and the incidence of influenza-associated pneumonia in a uk primary care cohort. influenza and other respiratory viruses we would like to acknowledge dr. sally mcnagny for her clinical insights and alison bourke for her contributions to the data curation.funding sources: no funding was received for this work. key: cord- -xmc kv authors: martin, jennifer l.; smith, julia title: why we march! feminist activism in critical times: lessons from the women's march on washington date: - - journal: womens stud int forum doi: . /j.wsif. . sha: doc_id: cord_uid: xmc kv abstract as professors, we have witnessed, anecdotally, a shift in doing social justice advocacy teaching. we have witnessed within some of our classrooms a more empowered hostility and intolerance to conversations pertaining to social justice. we agree that this phenomenon is pedagogical because this language usage not only teaches, but also legitimizes hate speech. we have witnessed the illogical extension of this hate speech with an increase in hate crimes across the country since the election, without peaceful protest and grassroots feminist activism, we fear that this speech, this pedagogy, will spread even more violent forms of hate. this research was conducted in and around the first women's march of . we wanted to know: what were marchers' prior histories of political activism prior to the election? if this was their first time participating in such a manner, how did the election and its early political fallout inspire marchers to attend? ) what plans did marchers have for political activism after the march? ) what can be learned from these participants about the current state of political activism in our current era? a total of individuals had taken part in the online survey. among the participants, % marched on washington, and % participated in the march in their local cities. we found that issues of gender equality were of great concern to many of the marchers. in particular, issues related to economic and social equity, including salary. these findings are interesting as they speak to the broader implications of gender equality. and, as the past few years have demonstrated, these issues continue to be of concern. the day after the election. . . i was traveling to iowa, with a layover at chicago o'hare. the purpose? to facilitate a diversity training at a community college in iowa. i was scared. my college students were contacting me. they were scared. one student said to me, "how am i going to live in the world now?" i cried in the airport. that evening, at the hotel restaurant i witnessed a female server describe to another female server how she had just been grabbed by her genitals by an intoxicated man. "it's open season," i thought. . . . (marcher/author ) three hundred thousand plus pink hats were the omnipresent symbol for the women's march on washington, in washington, d.c., on january , , the day after the inauguration of president donald j. trump. most hand-made, these hats were a grassroots provocation in response to trump's profane comment about grabbing women by their genitals. using language that attempts to make sexual assault permissible is not acceptable-and that was just one of the messages of the march held round the world. and bob bland soon combined their efforts, which led to thousands of people signing up via social media to march. the founders from the start worked to ensure that the movement was intersectional and inclusive. organizers originally expected , marchers, but the event ultimately drew , - , marchers to d.c., and the metro system had its second-busiest day in history--with over one million recorded rides, and no arrests. the new york times reported that the crowds of the women's march were three times the size of trump's inauguration, which they estimate at , attendees. sara ahmed, roxanne gay, and brittney cooper all wrestle with the idea of how to be a feminist when contradictions within our lived experiences conflict with our perceptions of what a feminist -should be.‖ as cooper argues, -. . . many young people don't see ‗feminism' as just a set of politics but as an identity that they must take on and perform. . . . feminism, it seems, comes saddled with its own baggage as an identity politic‖ (p. ). we understand that many young people chose not to self-identify as feminists, while also holding the same personal and political ideals as self-identified feminists, for fear of being attached to the stigmatized label (aronson, ) . according to feely ( ), -. . . the girl power movement became separated from its feminist core. . . . no wonder students are confused about feminism‖ (p. ). additionally, the demonization of feminism is still a popular troupe within various media outlets. what is known as liberal feminism is a vehicle to strive for gender parity through existing political and institutional structures. critical intersectional feminism, on the other hand, inherently criques the problems within said systems--as well as issues with liberal or -white‖ feminism for its lack of focus on issues facing women of color (clark, prentiss dantzler, & nickels, ) . critical intersectional feminism delves into how multiple identity markers shape one's experience in society and differs in terms of economics, politics, and social interactions; multiple oppressions are linked and must be conceptualized together (clark, prentiss dantzler, & nickels, ; crenshaw, ) . although liberal, or traditionally -white‖ feminism, has been critiqued and even repudiated by some scholars and activists, many critical and queer scholars of color have worked to create a new vision of feminism in theory, activism, and practice (clark, prentiss dantzler, & nickels, ; hooks, ; love, ) . prior to the election of , there were two dominant social scripts within popular media regarding feminism (martin, nickels, & sharp-grier, ) . one of these scripts is -empowerment feminism,‖ where individuals are free to define feminism on their own terms, devoid of a specific political platform; this script may have evolved through third-wave feminist texts occurring within the echo chamber of social media within a neo-liberal capitalist posteverything milieu. sounding good on its face, it ultimately served to separate people from coming together as a collective because there are not necessarily any shared collective goals. the second script is the post-feminist myth: that the goals of feminism have already been achieved, and thus feminism is no longer necessary. the election of may be the catalyst to merge these two lines of thinking into a new radical intersectional feminism and a radical intersectional feminist activism, where specific political goals are defined and achieved collectively. j o u r n a l p r e -p r o o f -anything goes‖ feminism stems from the neoliberal invention of -empowerment feminism,‖ which is individualistic in nature and does nothing to unpack or to fight the systemic institutional, societal, and cultural systems and constraints fostering oppression and maintaining patriarchal and racist barriers. the inherent critiques of the aforementioned hegemonic structures within radical feminism disappeared with empowerment feminism, and replaced institutional and societal critiques with individual responsibility, the myth of the meritocracy, and the devaluation of collection action. ringrose and walkerdine ( ) , pulling from mcrobbie, extend her conception of the -postfeminist masquerade,‖ where liberation no longer comes in the form of protests of social, sexual, and political inequities; instead, now feminism is revealed through the freedom of shopping and style-feminism as co-opted by corporations. the other -feminist‖ script is that we now are living in a post-feminist milieu, where feminism is no longer necessary because all of the battles have been fought and won, and women have achieved full equality; there are no problems but for the ones individually created. instead, each individual is responsible for their own realities-again a neo-liberal falsehood (ringrose, ; ringrose & walkerdine, ) . according to ringrose, harvey, gill, and livingstone ( ) , -the concept of ‗postfeminism' helps unpack and critique a contemporary sensibility that positions society as ‗beyond' feminism, where it is supposed that feminist goals of social and political equality have been met, making the need for feminism now obsolete. . .‖ (p. ). the underlying purposes of this ideology are to devalue feminist gains, and to dismantle current and future intersectional feminsit activism. according to bay-cheng ( ) , the neoliberal agenda, which has infiltrated popular culture, champions -. . . self-interested striving through depoliticized tropes of personal empowerment. . .‖ (p. ). neoliberalism heightens postfeminism, where financial and business j o u r n a l p r e -p r o o f success on individual levels supersede political struggle and solidarity (weber, ) . further, as weber argues, -neoliberalism disallows systemic injustices (like racism or sexism), arguing instead that in a free market, all players compete on a level playing field and thus rise or fall strictly on the strengths of their merit and effort. . .‖ (p. ). according to ringrose and walkerdine, the post-feminist moment involves a reinterpretation of feminist activism and history, in favor of a script that tells the story of gender equality, and the obsolescence of feminism in general. clearly, intersectional feminism has been misrepresented within the media and in popular culture in the interest of capitalism and neoliberalism. it will take intersectional feminist activism to alter this discourse. the feminist movement ebbs and flows, experincing periods of growth, as well as shrinkages, and backlashes (reger, ) . we argue that we are at the end of a period of backlash, and that the election of has served as a catalyst to invigorate intersectional feminist activism. grassroots feminist activism presupposes a bottom up approach to social change organizing and mobilization. intersectional grassroots feminist activism implies bottom up mobilization, and concerns that include issues of racial, socioeconomic, disability, and lgbtq+ justice, just to name a few. intersectional grassroots feminist activism is a unique frame through which to view, interpret, and interact with the world. a -frame‖ is a rhetorical device that encourages particular types of interpretations. frame analysis is a process to understand how people view situations, and interpret or process information. according to snow ( ) , there are four different types of frames: frame bridging, frame amplification, frame extension, and frame transformation. of these, frame transformation is most relevant to this study. frame transformation involves completely changing the rhetoric of the current state of affairs, and creating new values that have not been previously considered j o u r n a l p r e -p r o o f (clark, prentiss dantzler, & nickels, ) . the literature on social movements explains how different activists can gain more influence than others, mobilize others differently, and frame their movements differently, involving innovation, agency, and strategy (ganz, ) . when faced with new challenges, activist leaders use their knowledge to create unique solutions in order to inspire engagement (ganz, ) . according to ganz ( ): organizers motivate action by deepening people's understanding of who they are, what they want, and why. mobilizing feel-ings of anger, courage, hopefulness, self worth, community and urgency, they challenge feelings of fear, despair, self doubt, isolation, and apathy that inhibit action. they help people articulate their values as a shared story of challenges they face, why they must face them, and why others should help--rooted in who they are, where they've been, where they want to go. (p. ) according to han ( ), organizational context has a strong influence on individual choice to engage in activism; that is, the choice to participate in political activism may result from inspiring social interactions between current and potential activists. we theorize that after the election, people from around the world were more motivated to speak out, whether virtually or in-peron, to protest the ableist, racist, sexist, and homophobic rhetoric of the new president, and that many of these people were inspired to engage from online interactions with the organizers of the women's march via social media. in sum, according to han ( ), activism is crucial in making democracy work, and it is on the rise as technology changes how we do activism. however, naples ( a) argues that face-to-face organizing is more effective in activist efforts to retain control over the movement narrative. that being said, intersectional feminist praxis, such as the women's march on washington, and its sister marches around the world, are j o u r n a l p r e -p r o o f designed so that knowledge creation develops from the lived experiences of the activists; these lived experiences inherently contribute to the knowledge construction of intersectional feminist and intersectional feminist praxis, and to our understanding of inequality and oppression (naples, b). naples, inspired by paulo freire's concept of -conscientizacao‖ ( )--in that many intersectional feminist actors have created empowerment strategies in nonhierarchical forms, conceive of empowerment as a -counterhegemonic‖ project. for example, intersectional feminist praxis prioritizes local struggles that intersect with regional, national, and transnational politics. in the u.s., and globally, protest politics and the politics of dissent are often demonized and sometimes criminalized, on the one hand, and, on the other, dismissed as -useless or ineffective‖ (choudry, , p. ). activist movements are made up of individuals, and not primarily professional activists, who truly become the catalysts for change. the -great person‖ narrative, consisting of a grand leader necessary for change to occur is a myth, and reproduces a narrative of political change as dependent on individual achievements or charisma; this undermines the real on-the-ground part-time activists doing the work (choudry, ). much can be said for collective action, and strength in numbers, as opposed to focusing on movement leaders. according to norris ( ) , there are three main catalysts of -mass activism‖: low electoral turnout, rising anti-party sentiment, and the decay of civic organization. social movements with the goal of protest politics battle the prejudiced oppression placed on minorities. how does a global society deal with such anguish? as martin luther king jr. stated, -one has a moral responsibility to disobey unjust laws‖ (as cited in green, ). peaceful protests are a positive way to bring diverse groups of people together to create one voice against the oppressor. according to cooper, the election of brought intersectional feminist issues back to the fore, -in an era when we are experiencing a renewal of the war on women, through a severe reduction in access to abortion clinics and a pervasive rape culture that seems to have seen no abatement, women, cis and trans alike, need feminism more than ever‖ (p. ). since the women's march on washington in , more people of all ages are ready to engage in political activism (alter, ) . there are some common reasons why people choose to now engage in feminist activism. thousands of people chose to get involved in feminism activism after the election for intersectional reasons, such as, defending women's rights and the rights of other minorities who will be made vulnerable by trump (alter, ) . the fear of oppression was and is in the air. as one marcher, cheyenne, stated, -i feel like a lot of rights that we have are in danger. we're scared, and this is the only thing we can think of to at least try to do to help make things better‖ (as quoted in vick, ). after the election, many marchers asked themselves what was -scarier,‖ engaging in activism for the first time, or doing nothing while hard-fought civil rights were eroded. despite a fear of engagement, many choose to partake in activism for the first time. the idea of protecting freedoms mixed with the fear of losing rights are the common equation that inspired people to the streets (alter, ) . protecting hard-won rights and freedoms, and the fear of losing them, are not the only reasons why people choose to become active in social justice issues after the election. williams brooks ( ) explains another reason, -people are moved by the sense of possibility, a sense of hope‖ (as quoted in vick, p. ). it is this sense of hope that inspires people, a sense of coming together to create change. as one marcher stated, -i'll have to focus on the areas that i have in common with the marginalized community, not on the distinctions that would separate us‖ (as cited in alter, ) . that is how and why diverse groups of people can peacefully march j o u r n a l p r e -p r o o f together even though they may not all be there for the same exact reason; they can come together for a common end goal. as andiola stated, -part of organizing is that we're not all going to be marching in the same rhythm‖ (as cited in vick, p. , ) . children marched beside their parents, and older men and women mingled with millennials. these issues bring together a mixing of ideology that inspires more to get involved (holmstrom, ). people become passionate for social activism because of the feeling of belonging, being a part of something that is bigger than the self. individuals who want their voices to be heard can have them magnified by the collective. this is why social activism is linked to freedom of speech; it allows people to get out into the streets and use their voices for a particular political purpose, and to come together with others who feel the same. the overall goal is to have people from different backgrounds advocate for their own communities (levitov, ) . according to levitov and kaaland ( ) , -it is logical that students are more likely to become effective and active members of society if they are allowed more participation in their own educational decision-making, from research topic choice to analyzing their learning and engaging in meaningful thinking and analysis‖ (p. ). the reason for marching comes from wanting to join others who are using their freedom of speech for a cause (levitov, ) . freedom is of value to everyone, and it gives people the right to take to the streets and sound their voices (levitov, ) . according to schussman and soule ( ), individuals possessing the following characteristics are more likely to become engaged in political activism: an interest in politics, access to information, self-efficacy, and a liberal orientation. being invited by another person to engage in activism makes some people more likely to engage in protest; however, there are some who engage in protest of their own accord (benford & snow, ) . according to whittier we are both white women professors working at predominantly white institutions in the disciplines of teacher education and educational leadership. we both consider ourselves to be feminists, and have engaged in previous forms of activism. one is a full tenured professor, and one is an assistant professor. the lead researcher attended the march in d.c., and the other author attended a march in ann arbor, michigan. we investigate this topic through an intersectional feminist lens (crenshaw, ), paying particular attention to the intersectional identities of the marchers. our conception of feminism is the philosophy that drives the action to end all forms of oppression (martin, ) . this lens allows for the interrogation of social, educational, and political factors that impact our milieu (chapman, ) , with the end goal of social justice (decuir & dixson, ) . our intersectional feminist lens drives us to seek to determine how oppression is perpetuated, for the j o u r n a l p r e -p r o o f purposes of undermining of all forms of bias within systems and institutions. our lens is also informed by gramsci's concept of organic intellectuals emerging from grassroots social movements, and knowledge creation through praxis. we are cautioned by naples ( b), as she reminds us, intersectional feminist praxis presupposes that intentionality must be paired with strategies for empowerment. we conducted this study to illuminate the perspectives of individuals whose voices are in our desperation after the election: the political and social fall out as a result (e.g., increases in hate crimes and online and in-person harassment of women and other historically marginalized people), we needed to feel -of use.‖ and, we wanted to take the temperature of the country, as much as we could, perhaps to prognosticate where the future would lead us: would the women's march inspire more individuals and groups to become more actively engaged politically? and, so, we created a survey, and attempted to inspire marchers to take it: either during the march, on their phones, or later when they got home. the research questions guiding this study were: ). what were marchers' prior histories of political activism prior to the election? if this was their first time participating in such a manner, how did the election and its early political fallout inspire marchers to attend? ). what plans did marchers have for political activism after the march? ). what can be learned from these participants about the state of political activism in our current era? we collected data during the women's march on washington, january , , the day after donald j. trump's inauguration. the lead author/researcher passed out approximately cards containing a link and a code to an online survey. by the end of the march and in the days after, people had taken the online survey. among the participants, % marched on washington, and % participated in a march in their local cities. participant characteristics are shown in table . in this table, the first characteristic was a measure of age in years, which is described using mean and standard deviation in the first column. the remaining descriptors were categorical, with the percentages given in the second column. the majority of participants in this study were white, heterosexual females. the widest diversity observed among participants was in their political party affiliation, although here too the majority identified as democrat. recognizing reflexivity involves acknowledging the ways in which -our own agendas‖ impact our research at all points, including analysis, and interpretation (hesse biber, , p. ) . moreover, our recognition of the reflexive process similarly demands that we consider our own biases, and how they impact what we choose to study, our motivations for the analysis, and our methodological approach to study (hesse biber, ) . as critical feminist scholars and activists, this topic is one of personal, political, and scholarly significance. we practiced content validation in order to ensure not only applicability but authenticity of information and interpretation (carlson, ; hesse biber, ) . we used saldaña's ( ) approach to thematic analysis in order to develop codes from our data. the process yielded seven themes that were consistent across the three open-ended questions. table shows the resulting themes, our definition of the theme, codes that were used in the development of the theme, and exemplar comments that illustrate the themes. in general, the findings from table demonstrate the emergent process undertaken with data coding. from participants, we coded , statements into the codes and finally the themes identified. we then entered these codes into spss software version . . we identified participants' responses by major themes as well as by the categories that made up each theme. we determined these themes and codes across the three questions addressing why the participants marched, what they hoped to accomplish, and what concerned them most about the election. the total j o u r n a l p r e -p r o o f number of categories identified by participants across their responses concerning why they marched ranged from zero to , for what they hoped to accomplish ranged from zero to , and for what concerned them in the election ranged from zero to . for the major themes, we collapsed the responses to identify the number of categories that the participant identified within each theme. we then re-coded these measures (seven measures for each of three questions for a total of ) in two ways. first, we dichotomized each measure to determine whether the participant identified any of the categories in that theme as relevant, giving each participant a -yes‖ or -no‖ code for each theme. as such, the percentage of participants who identified each theme could total more than %, as one person could have identified more than one theme in their responses. then, we created a new measure that captured, across the seven major themes, which theme in which they had the most responses for each question. this indicator had seven categories, with the percent of participants who identified each category as the strongest adding to % (including no theme identified as -no response given‖). finally, for two of the themes (gender issues and issues other than gender), we further analyzed the distribution of individual category responses, first across the entire sample, and then only for those participants who identified that theme as their strongest response. we examined the coded responses across all participants concerning three main figure is the very large portion ( . %) of participants who identified gender issues as their strongest response to the question asking about their greatest concern after the election. from this, we can conclude that the status and safety of individuals of all gender identities were a concern. the next highest portion had the strongest response to issues other than gender ( . %). when examining the distribution of participants' strongest response to why they marched, the largest reason identified was issues other than gender ( . %), closely followed by gender issues ( . %) and protest and dissent ( . %). when asked what they hoped to accomplish, the largest portion identified protest and dissent as their strongest response ( %), followed by gender issues ( . %), and solidarity or empowerment ( . %). while no participants gave no response to the second and third question, a fifth of them did not respond to the question of why they marched ( . %). gender issues were an important area as to both why participants marched, and their greatest concerns after the election. it is useful to examine the codes within this category to learn more detailed information about the types of responses made. figure shows the distribution of coded responses within this category for all participants, with the responses to -why i marched‖ in black bars and -greatest concern of the election‖ in gray bars. the largest response level in this figure is for concerns about equal pay as a reason to march ( % indicated this area as a reason); yet very few participants identified this issue as their greatest concern in the election ( . %). other reasons for marching that were j o u r n a l p r e -p r o o f identified by a larger portion of participants overall were to support feminism ( %), and to challenge misogyny and patriarchy ( %). responses that were reported the most across all participants for their concerns about the election were supporting reproductive rights and health ( . %), sexual assault issues ( . %), and challenging misogyny and patriarchy ( . %). when focusing on participants who identified gender issues as their strongest area of response, the patterns were similar but more extreme. figure shows the distribution of these participants' responses (n = for "why i marched" shown in black bars and n = for "greatest concern of the election shown in gray bars). the largest response level in this figure was again for concerns about equal pay as a reason to march ( % indicated this area as a reason), yet an even smaller portion of these participants identified this issue as their greatest concern in the election ( . %). other reasons for marching that were identified by a larger portion of these participants were again to support feminism ( %) and to challenge misogyny and patriarchy ( %). responses that were reported the most across participants who selected gender issues for their concerns about the election were quite similar to the distribution of the full sample-supporting reproductive rights and health ( %), sexual assault issues ( %), and challenging misogyny and patriarchy ( %). the similarity could well be due to the fact that a large portion of the participants identified gender issues as their main concern, as noted in figure . j o u r n a l p r e -p r o o f as shown in figure , the largest portion of participants identified issues other than gender as the strongest reason they marched, and this area was the second highest category identified as the strongest concern of the election. it is useful to examine the codes within this category to learn more detailed information about the types of responses made in these two areas. figure shows the distribution of coded responses within this category for all participants, constructed in the same manner as figure . the two codes that were identified by the largest portion of all participants were social class ( . %) and human rights ( . %). interestingly, a very small portion of participants identified either of these areas as a concern in the election ( . % and . % respectively). while the distribution of these codes was small for concerns about the election when examined across all participants, the largest responses were to racism ( . %), lbgtq+ ( . %), and health care ( %). these response levels were similar as those reported for reasons for marching. when focusing on participants who identified issues other than gender as their strongest area of response, the patterns were similar, but, again, more extreme. figure shows the distribution of these participants' responses (n = for -why i marched‖ shown in black bars and n = for -greatest concern of the election‖ shown in gray bars). every participant who identified issues other than gender as the strongest reason they marched indicated social class in their responses ( %), but, again, only a small portion of those who indicated this area as their strongest concern about the election did so ( . %). after j o u r n a l p r e -p r o o f social class, over half of these participants identified human rights as a concern ( . %), and about a third indicated lgbtq+ issues ( . %), racism ( %), and supporting disempowered people in general ( . %). for those participants who identified issues other than gender as their strongest area of concern about the election, the largest portion of these people identified (in descending order) racism ( . %), immigration/the wall ( . %), and lgbtq+ issues ( . %). in general, it can be concluded from these data that issues of gender equality were of great concern to many of the marchers, in particular, issues related to economic and social equity, including salary. these findings are interesting as they speak to the broader implications of gender equality. and, as the past few years have demonstrated, these issues continue to be of concern. the obligation of anyone who thinks of himself as responsible is to examine society and try to change it and to fight it-at no matter what risk. this is the only hope society has. this is the only way societies change-james baldwin after the election, i found it difficult to even turn on the news. for me, this was not a typical election. i was accustomed to my preferred candidates losing, but this time it was different. it was personal. it was an affront. it was an attack. attending the march made me feel there was some kind of hope. helping students register to vote was also an affirming act for me. (marcher/author) since the women's march on washington in , an almost innumerable amount of concerning events have taken place at the hand of the trump administration. despite advances in the public discourse over issues of sexual violence (re: the -me too,‖ and -time's up‖ movements), women's experiences and credibility seem to still up for debate. this issue was particularly evident in the hearings for the successful trump nominee for supreme court justice, brett kavanaugh. as the world watched, dr. christine blasey ford testified with the candor and j o u r n a l p r e -p r o o f specificity of a professor of psychology who had experienced sexual trauma, and understood the neurological implications of such events. yet, while the particular function and forum for her testimony was unique, her experiences were not. sexual assault and harassment continue to be a reality for the vast majority of women, many of whom live and study on college campuses (brown, ) . in the end, dr. blasey ford's testimony was deafened by judge kavanaugh's overwhelming privilege. it would be interesting to revisit the questions posed to the participants at the women's march on washington with these same participants. are we feeling less passionate or more emboldened by the actions of the president and others in power? this reality poses important questions for academics as well as educators. how will we continue to encourage voice and agentic social action for people of all gender identities? how can the continued delegitimization of women's experiences be countered? despite the frustrations many of us have faced in the years since his election, the presidency of donald trump will most certainly stand as a turning point in progressive social movements. we are currently faced with the global pandemic that is covid- . as we sit, sheltering-in-place, digital social activism decries the administration's blatant disregard of the seriousness of this crisis, the implications of which are yet untold. we look to activists for the hope that is so necessary during our unprecedented times. j o u r n a l p r e -p r o o f new friends, common foe promoting feminist amefricanidade: bridging black feminist cultures and politics in the americas. meridians: feminism, race, transnationalism feminists or -postfeminists?‖: young women's attitudes toward feminism and gender relations technologizing feminist pedagogy: using blog activism in the gender studies classroom why we marched framing process and social movements: an overview and assessment a dynamic force in our community: women's clubs and second-wave feminism at the grassroots groundswell: grassroots feminist activism in postwar america bridging the divide: connecting feminist histories and activism in the classroom do you plan to engage in other forms of activism related to women's/gender issues in the future? yes no much more politically active than you were before b. somewhat more politically active than you were before c . what did you hope to accomplish through your participation in the women's march today. . what specific events related to women and gender during the presidential campaign and election caused you the greatest concern? . have you engaged in activism related to women's/gender issues before today? yes no j o u r n a l p r e -p r o o f an expression of concern for issues other than those of gender that were raised during the election process key: cord- - ch na authors: epstein, robert s.; aapro, matti s.; basu roy, upal k.; salimi, tehseen; krenitsky, joann; leone-perkins, megan l.; girman, cynthia; schlusser, courtney; crawford, jeffrey title: patient burden and real-world management of chemotherapy-induced myelosuppression: results from an online survey of patients with solid tumors date: - - journal: adv ther doi: . /s - - - sha: doc_id: cord_uid: ch na introduction: chemotherapy-induced myelosuppression (cim) is one of the most common dose-limiting complications of cancer treatment, and is associated with a range of debilitating symptoms that can significantly impact patients’ quality of life. the purpose of this study was to understand patients’ perspectives on how the side effects of cim are managed in routine clinical practice. methods: an online survey was conducted of participants with breast, lung, or colorectal cancer who had received chemotherapy treatment within the past months, and had experienced at least one episode of myelosuppression in the past year. the survey was administered with predominantly close-ended questions, and lay definitions of key terms were provided to aid response selection. results: of participants who completed the online survey, ( %) had breast cancer, ( %) had lung cancer, and ( %) had colorectal cancer. anemia, neutropenia, lymphopenia, and thrombocytopenia were reported by %, %, %, and % of participants, respectively. most participants ( %) reported having received treatment for cim, and % of participants recalled chemotherapy dose modifications as a result of cim. although most participants believed their oncologist was aware of the side effects of cim, and treated them quickly, % of participants felt their oncologists did not understand how uncomfortable they were due to the side effects of cim. overall, % of participants considered cim to have a moderate or major impact on their lives. conclusion: the data highlight that despite the various methods used to address cim, and the patient-focused approach of oncologists, the real-world impact of cim on patients is substantial. improving communication between patients and health care providers may help improve patients’ understanding of cim, and foster shared decision-making in terms of treatment. additional insights from patients should be obtained to further elucidate the totality of life burden associated with cim. on how the side effects of cim are managed in routine clinical practice. methods: an online survey was conducted of participants with breast, lung, or colorectal cancer who had received chemotherapy treatment within the past months, and had experienced at least one episode of myelosuppression in the past year. the survey was administered with predominantly close-ended questions, and lay definitions of key terms were provided to aid response selection. results: of participants who completed the online survey, ( %) had breast cancer, ( %) had lung cancer, and ( %) had colorectal cancer. anemia, neutropenia, lymphopenia, and thrombocytopenia were reported by %, %, %, and % of participants, respectively. most participants ( %) reported having received treatment for cim, and % of participants recalled chemotherapy dose modifications as a result of cim. although most participants believed their oncologist was aware of the side effects of cim, and treated them quickly, % of participants felt their oncologists did not understand how uncomfortable they were due to the side effects of cim. overall, % of participants considered cim to have a moderate or major impact on their lives. conclusion: the data highlight that despite the various methods used to address cim, and the patient-focused approach of oncologists, the real-world impact of cim on patients is substantial. improving communication between patients and health care providers may help improve patients' understanding of cim, and foster shared decision-making in terms of treatment. additional insights from patients should be obtained to further elucidate the totality of life burden associated with cim. this study looked at people with cancer who received chemotherapy and developed a condition where their bone marrow activity was reduced, called myelosuppression. this meant they had fewer red blood cells that carry oxygen around the body, white blood cells that help fight infections, and platelets that help the blood to clot. the researchers wanted to understand how chemotherapy-induced myelosuppression affects peoples' lives and their cancer treatment, and people's experiences of treatment for myelosuppression. overall, people in the usa with breast, lung, or large bowel (colorectal) cancer completed an online survey. they had all received chemotherapy in the last year, and had myelosuppression at least once during their treatment. the survey showed that around in people ( %) had to be treated for myelosuppression, and around in people ( %) felt they received treatment for myelosuppression quickly. chemotherapy was delayed, reduced, or stopped because of myelosuppression in around in people ( %). around in people ( %) felt their oncologist did not understand the discomfort that myelosuppression caused them, and around in people ( %) felt that myelosuppression made their quality of life worse. the researchers concluded that because myelosuppression impacts peoples' lives and their ability to keep receiving chemotherapy to treat their cancer, effective prevention and treatment for this condition are important. better communication between people and their health care teams could help them to understand how people experience myelosuppression and make plans for treatment together. keywords: anemia; chemotherapy; myelosuppression; neutropenia; oncology; online survey; patient burden; real-world; symptom management; thrombocytopenia why carry out this study? the side effects of chemotherapy, including myelosuppression, remain a major source of concern for both patients and health care providers. the consequences of chemotherapyinduced myelosuppression (cim) include anemia, thrombocytopenia, and neutropenia, all of which can cause severe complications, and limit the ability of patients to receive chemotherapy on time and at standard-of-care doses. prior research has documented patients' perceptions of the side effects of chemotherapy; however, research into the real-world impact of cim on patients' lives is limited, and the 'patient voice' on cim, and how it is currently managed, is lacking. what was learned from the study? despite the current availability and use of various supportive care interventions, cim places a substantial burden on patients with advanced solid tumors, impacting many aspects of their daily lives. this survey provides valuable insights into patients' perspectives on the impact and management of cim, and suggests that methods to prevent or proactively manage cim could improve the quality of life of patients receiving chemotherapy. myelosuppression is an important treatmentrelated toxicity among patients with cancer [ ] [ ] [ ] , and occurs when the actively dividing hematopoietic stem and progenitor cells (hspcs) in the bone marrow, which give rise to blood cell lineages, are damaged by cytotoxic chemotherapy. chemotherapy-induced myelosuppression (cim) commonly manifests as anemia, neutropenia, thrombocytopenia, and/ or lymphopenia [ , [ ] [ ] [ ] , and often results in an increased risk of life-threatening infections, shortness of breath, fatigue, and, potentially, excess bleeding. cim is currently managed with chemotherapy dose reductions and delays, in addition to rescue interventions that stimulate or mobilize white cells (growth factors, such as granulocyte colony-stimulating factors [g-csfs]); replenish red blood cells (rbcs) and platelets (transfusions); or stimulate rbc precursors (growth factors, such as erythropoiesisstimulating agents [esas]) [ , [ ] [ ] [ ] . despite the use of these interventions, however, clinically significant cim continues to be a major acute toxicity of cytotoxic chemotherapy, possibly because currently available interventions are administered reactively, i.e., after hspcs have been damaged by chemotherapy. the wide application of chemotherapy dose reductions and/or delays can also reduce the dose intensity of the chemotherapy and, potentially, its intended antitumor efficacy [ , [ ] [ ] [ ] . cim is particularly relevant for patients with small cell lung cancer (sclc), breast cancer, and colorectal cancer (crc), for which chemotherapy, alone, or in combination with immune checkpoint inhibitors, remains a cornerstone of treatment [ ] [ ] [ ] [ ] [ ] . a systematic literature review to assess the real-world effectiveness and tolerability of treatments for sclc, for example, showed that hematologic toxicities were the most commonly reported adverse events (aes); neutropenia was reported in approximately two-thirds of patients receiving first-line chemotherapy, and almost threequarters of patients receiving second-line chemotherapy [ ] . research into patients' perceptions of the side effects of chemotherapy, including those associated with cim, has been well documented, particularly with regard to symptoms of fatigue and effects on family [ ] [ ] [ ] [ ] [ ] . overall, these studies suggest that patients' concerns extend beyond physical symptoms to include non-physical concerns over daily routines, emotional well-being, and relationships [ , [ ] [ ] [ ] . by comparison, much less is known about how the management of cim-associated side effects impacts patients. one survey of , adult cancer patients assessed the burden of time associated with medical visits for the management of chemotherapy-induced anemia (cia) and neutropenia on patients and caregivers, and found that each visit involved approximately h for the patient and over h for caregivers [ ] . likewise, several surveys conducted to determine the impact of blood transfusions on patients with cia have concluded that the time spent travelling to medical facilities, along with blood testing and the procedure itself, presents a considerable burden to patients [ ] [ ] [ ] . while these studies highlight the logistic burden associated with cim, there remains a need for more research into the broader impact that cim and its management has on patients' lives, and to raise awareness among patients regarding the contribution of cim to the overall toxicities associated with chemotherapy. the purpose of the current study was to capture the perceptions, experiences, and challenges that patients encounter when diagnosed with myelosuppression as part of chemotherapy treatment for advanced solid tumors. here, we describe patients' perspectives on the management of cim among those with breast, lung, and colorectal cancers, and the overall impact that myelosuppression has on patients' lives. the objectives of the study were to understand what treatments were administered for cim and the challenges that patients encountered in receiving these; determine from a patient perspective whether cim impacted dose/frequency of chemotherapy; gain insights into which member of the care team paid most attention to symptoms associated with cim; and to capture the ''patient voice'' in how cim impacted their life. the study was conducted in accordance with the declaration of helsinki, and electronic consent was obtained from all participants prior to study entry. the study was reviewed by the sterling institutional review board (irb), and granted exemption status according to department of health and human services research criteria, signifying that full irb review was not required. participants were identified from an online us panel of patients with a wide range of health conditions, including cancer. the target sample size was participants living with breast cancer, lung cancer, or crc, with a target ratio of : : per cancer type, respectively. male and female participants aged years or more were included if they had received chemotherapy treatment within the past months, and had experienced at least one episode of myelosuppression in the past year, encompassing the following: required blood transfusion; required g-csf or granulocyte macrophage colonystimulating factor (gm-csf); required platelet transfusion; had a serious infection such as pneumonia or sepsis after receiving chemotherapy treatment; required esas to increase rbc count; or diagnosed with myelosuppression but with no treatment intervention. the survey was designed, as per the study objectives, considering a review of published literature, and the draft questions were reviewed by experts for scientific content and question design. questions, including screening and demographic questions, as well as core survey content, were presented sequentially in several formats, which included a choice of one response from a defined list of possible statements; questions that asked the participant to choose multiple responses (e.g., select all that apply); dichotomous questions (yes/no); and statements where the participant was asked to indicate their agreement using a likert scale (e.g., = strongly disagree, = disagree, = neutral/not sure, = agree, = strongly agree). lay definitions of key terms were provided (upon cursor selection) to aid response selection (table ) . participants were also asked to provide verbatim responses to a single openended question about how the side effects from myelosuppression impacted their lives. a total of participants started the survey, of whom were disqualified, most commonly for not having received chemotherapy in the previous months (n = ) or for not having lung, breast, or colorectal cancer (n = ). a further participants only partially completed the survey and were excluded from the analysis. the full survey was completed by participants between november , and december , . of these, ( %) recalled being told by their health care provider (hcp) that they had at least one episode of myelosuppression, and ( %) recalled receiving treatment associated with myelosuppression. sixty percent of the participants were female, most ( %) were under years of age, and % were working (table ). fifty-one percent of the participants had breast cancer, % had lung cancer (of whom % had sclc), and % had crc. seventy-five percent of participants had been diagnosed with cancer within the previous years. all participants self-identified as having experienced some form of myelosuppression (anemia, neutropenia, thrombocytopenia, lymphopenia) in the past year. self-reported ( ) ( ) ( ) a participants could select more than one option comorbidities included diabetes ( %), depression ( %), and hypertension ( %). most participants reported that they had been diagnosed with anemia ( %) or neutropenia ( %), while fewer participants reported a doctor's diagnosis of lymphopenia ( %) or thrombocytopenia ( %; table ). approximately one-third of participants reported receiving either g(m)-csf, esas, or rbc transfusions ( %, %, and %, respectively); platelet transfusions were reported by % of participants; and % reported no treatment (fig. in total, % of participants recalled chemotherapy dose delays, reductions, discontinuations, and/or changes due to myelosuppression (fig. ) . myelosuppression was most frequently managed by an oncologist, and most participants thought that their oncologist was aware of their side effects and treated them quickly (table ) ; however, % of participants felt that their side effects were not treated, and % felt that their oncologist did not understand how uncomfortable they were as a result of myelosuppression side effects. results were similar across the three tumor types (table ) . most participants ( %) considered myelosuppression to have a moderate or major overall impact on life (table ) . participant-reported impact of myelosuppression was significantly higher among participants aged below years compared with those aged at least years (p = . ); however, no significant differences were observed when participants were stratified by gender, employment status, cancer type, or comorbidities (depression, diabetes, hypertension). some illustrative verbatim responses regarding the impact of myelosuppression side effects included the following: did not get out as much, not able to work, always feeling tired. had to take preventative measures to guard against diseases and germs. it has made everyday life more difficult in all areas. i had to severely curtail my social activities so i was not exposed to germs. i avoided family holiday activities [and] had some depression because of lack of social interaction and concern over potential infection. studies seeking to gain insight into patients' perspectives on the burden of cim are important, as hematologic side effects can have a substantial negative impact on patients' quality of life and may contribute to suboptimal treatment outcomes [ , , , ] . many studies have sought to understand patients' perceptions of the symptoms associated with cim, but few studies have been designed to better understand patients' perspectives on the overall impact of cim and how it is managed in daily practice. in the current survey, anemia and neutropenia were reported most commonly ( % and % of participants, respectively), whereas thrombocytopenia and lymphopenia were relatively less common ( - % of participants). the actual rates of myelosuppression reported in the survey are higher than would be expected in an all-comer population, given that we focused only on participants with a diagnosis of a participants selected (agree) or (strongly agree) on a - scale myelosuppression and/or treatment for myelosuppression. in a study of electronic medical records from evaluable patients diagnosed with sclc, for example, real-world rates of chemotherapy-induced neutropenia, anemia, and thrombocytopenia were %, %, and %, respectively [ ] . the finding that anemia and neutropenia were more common than thrombocytopenia is consistent with the prescribing information for a range of myelosuppressive chemotherapy treatments, although many report neutropenia as being more common than anemia [ ] . it is possible that the relatively broad inclusion criteria in this online survey may have led to overestimation of the incidence of cia, since participants with anemia resulting from the cancer itself or other underlying causes would also have been included. in line with the finding that most participants were diagnosed with anemia or neutropenia, g(m)-csf, esas, and rbc transfusions ( ) were described as the most common supportive care interventions, each being reported in approximately one-third of participants. retrospective studies of supportive care use among us patients with solid tumors or lymphoma have shown that - % of patients receive prophylaxis with myeloid growth factors [ , ] ; however, far fewer patients receive esas [ , ] . the low utilization of esas in the usa may partly reflect the us food and drug administration's decision in to restrict esa use to patients with a hemoglobin (hb) level of less than g/dl owing to concerns over rapid tumor progression and shortened overall survival with esas at hb greater than g/dl [ ] . similarly, there has been a shift toward a more restrictive policy on transfusions for cia in recent years, with guidelines supporting a hb threshold of less than g/dl for most patients [ ] . despite these recommendations, the findings of the current study, along with previous reports on patterns of supportive care use in patients on chemotherapy, suggest that, in general, interventions such as growth factors and transfusions are commonly used. indeed, only % of survey participants in the current study reported receiving no treatment. this finding is notable, as the supportive care interventions themselves can present additional risks, such as bone pain with g(m)-csf; thrombotic events with esas; and transfusion reactions and infections with rbc and platelet transfusions; as well as being a burden to patients [ , , [ ] [ ] [ ] ] . approximately two-thirds of survey participants experienced an issue with continuing on their current chemotherapy regimen due to myelosuppression, reflecting the substantial impact of hematologic side effects on standardof-care treatment schedules and doses. this is in line with findings from studies in patients with advanced non-small cell lung cancer and breast cancer. in these studies, chemotherapy was delayed by at least week in approximately one-third of patients, and approximately % of patients had a relative dose intensity of less than % [ , ] . such dose modifications are clinically relevant, as maintaining appropriate dose intensity is important in both the curative setting and in treatment with palliative intent [ ] . for this reason, the development of equally effective chemotherapy regimens that carry less long-term risks has been an important focus of research. the frequent, uninterrupted administration of low-dose (metronomic) chemotherapy, for example, is thought to result in sustained, low blood levels of chemotherapy, with fewer side effects, and a reduced need for supportive therapies [ ] . however, although alternative dosing strategies may be useful to reduce cim, they should be limited to situations where dose reductions are not expected to compromise long-term outcomes. participants reported that myelosuppression was most frequently managed by an oncologist, as opposed to a nurse, physician assistant, or other hcp. this differs to other areas of supportive care, such as the management of nausea and vomiting, where oncology nurses are often better placed to manage side effects, as they have more frequent contact with individual patients and offer a holistic approach to care [ , ] . nevertheless, most participants had confidence in their oncologist to be aware of and treat side effects, although some perceived that their oncologists did not understand the impact that side effects had on their lives. a previous study examining patients' perceptions of the physician-patient relationship and communication about aes also found that most patients reported having a good relationship with their physician, and that they had extensive discussions about what side effects might occur. however, those discussions did not always provide patients with sufficient understanding or adequately equip patients to cope with the aes [ ] . overall, the results are encouraging, but suggest that there is a need for improved communication between patients and their treating physician, both in terms of improving patients' understanding of potential side effects and in listening to their perspectives on how these events affect everyday life. indeed, improved patient-physician communication would help foster shared decision-making, especially when critical decisions regarding treatment discontinuation or treatment changes must be made. it is notable that most participants, particularly younger participants, felt that myelosuppression side effects had a moderateto-major life impact, despite the fact that most perceived their symptoms to be expected and treated quickly. in particular, in their verbatim responses, many participants described a substantial negative impact on their ability to carry out daily tasks, due to fatigue and concerns about infection. this is especially pertinent in light of the covid- pandemic that occurred following the completion of this survey, which is likely to further exacerbate the impact of myelosuppression on patients' lives by creating an additional burden to health care systems and by heightening fears that a weakened immune system will put oncology patients at risk of severe complications from the virus [ , ] . one limitation of this study is that the use of an online patient database to engage participants may have created bias in favor of reflecting the preferences of participants with more familiarity with online technologies, or who were healthier than the average oncology patient. in principle, patients with worse disease characteristics, requiring aggressive treatment for cancer and/or cim may not have been interested or able to participate in the survey. the study is also based solely on patient selfreport, and the extent to which patients can accurately recall this type of information is not known. thus, these findings should be considered alongside findings from other patient populations and using other methods, such as prospective observation, patient diaries, and/or interviews within clinical settings, to confirm and extend the findings. on the other hand, a key strength of using an online platform is that participants may be more willing to share information than in a face-to-face interview, and may be less likely to be directed toward a socially desirable response. additionally, the use of verbatim responses provides important information on aspects of the patient burden of cim that would not otherwise be captured in a closed response questionnaire. despite the use of chemotherapy dose reductions and delays, g(m)-csf, esa injections, and blood transfusions to address cim, the findings of this survey suggest that the real-world impact of myelosuppression on patients is substantial, with almost all participants reporting a moderate or major impact on their lives. the data highlight that there is an unmet need to prevent or proactively manage cim to improve patients' quality of life and to improve communication between hcps and their patients. funding. sponsorship for this study, the rapid service and open access fees were funded by g therapeutics, inc. (research triangle park, nc, usa). medical writing and editorial assistance. medical writing assistance in the preparation of this article was provided by fiona scott, contracted by alligent europe (envision pharma group). plain language writing support was provided by lauri arnstein, envision pharma group. support for all assistance was funded by g therapeutics, inc. authorship. all named authors meet the international committee of medical journal editors (icmje) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. this project. tehseen salimi was a paid employee of g therapeutics, inc., at the time of study completion and manuscript preparation, and is currently a paid employee of taiho oncology, inc. joann krenitsky is a consultant for g therapeutics, inc. megan l. leone-perkins is a paid consultant for healthi-vibe, a division of corrona llc. cynthia girman is a consultant for g therapeutics, inc., and epstein health, llc. courtney schlusser is a consultant for g therapeutics, inc., and epstein health, llc. jeffrey crawford has served as an advisor to amgen, coherus, g therapeutics, inc., and pfizer. compliance with ethics guidelines. the study was conducted in accordance with the declaration of helsinki, and electronic consent was obtained from all participants prior to study entry. the study was reviewed by the sterling irb, and granted exemption status according to department of health and human services research criteria, signifying that full irb review was not required. data availability. the datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. open access. this article is licensed under a creative commons attribution-noncommercial . international license, which permits any non-commercial 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/bync/ . /. antineoplastic agents and the associated myelosuppressive effects: a review how i manage the toxicities of myeloma drugs trends in recommendations for myelosuppressive chemotherapy for the treatment of solid tumors managing thrombocytopenia associated with cancer chemotherapy preventing chemotherapy-induced myelosuppression by 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small-cell lung cancer (sclc) treatments: a systematic literature review (slr) usefulness of the perform questionnaire to measure fatigue in cancer patients with anemia: a prospective, observational study experiencing neutropenia: quality of life interviews with adult cancer patients patient and health care provider perceptions of cancerrelated fatigue and pain patient perceptions of symptoms and concerns during cancer chemotherapy: 'affects my family' is the most important changing patient perceptions of the side effects of cancer chemotherapy the social and emotional toll of chemotherapy-patients' perspectives the impact of medical visits for chemotherapy-induced anemia and neutropenia on the patient and caregiver: a national survey transfusions and patient burden in chemotherapyinduced anaemia in france a retrospective study to evaluate the time burden associated with outpatient red blood transfusions indicated for anemia due to concomitantly administered chemotherapy in cancer patients real-world burden of myelosuppression in patients with small cell lung cancer (sclc): retrospective, longitudinal data analysis use and patterns of supportive care among patients receiving myelosuppressive chemotherapy for breast cancer, colorectal cancer, lung cancer, or non-hodgkin's lymphoma in us clinical practice patterns of chemotherapy-associated toxicity and supportive care in us oncology practice: a nationwide prospective cohort study current burden of chemotherapy induced anemia and patterns of erythropoiesis-stimulating agents utilization nordyke rj. use of erythropoiesis-stimulating agents among chemotherapy patients with hemoglobin adv ther exceeding grams per deciliter transfusion practice patterns in patients with anemia receiving myelosuppressive chemotherapy for nonmyeloid cancer: results from a prospective observational study guidelines for the use of platelet transfusions chemotherapy dose intensity and overall survival among patients with advanced breast or ovarian cancer role of nurses in the assessment and management of chemotherapy-related side effects in cancer patients the patient-healthcare professional relationship and communication in the oncology outpatient setting: a systematic review patients' perceptions of physician-patient discussions and adverse events with cancer therapy covid- : global consequences for oncology how young patients with cancer perceive the covid- (coronavirus) epidemic in milan, italy: is there room for other fears? pediatr blood cancer we give special thanks to the patients who participated in the survey, and to dr upal k basu roy from the lungevity foundation (lung cancer advocacy community) for his involvement and authorship. key: cord- -al m lou authors: wolka, eskinder; zema, zewde; worku, melkamu; tafesse, kassahun; anjulo, antehun alemayehu; takiso, kassahun tekle; chare, hailu; kelbiso, lolemo title: awareness towards corona virus disease (covid- ) and its prevention methods in selected sites in wolaita zone, southern ethiopia: a quick, exploratory, operational assessment date: - - journal: risk manag healthc policy doi: . /rmhp.s sha: doc_id: cord_uid: al m lou background: the novel corona virus disease (covid- ) presents an important and urgent threat to global health and its effect is expected to get even worse in the middle- and low-income countries where the health system is weak and fragile. timely access to accurate information and public awareness on prevention methods is one of the feasible interventions in these countries. identifying level of public awareness on disease prevention is important to mitigate the pandemic. the aim of this study was to explore the level of awareness and prevention methods of covid- among residents in wolaita zone, southern ethiopia. methods: a qualitative study using a qualitative descriptive approach was conducted. community members engaged in different service sectors were selected purposively. a total of in-depth interviews were done. the transcripts were imported into opencode version . software packages. a qualitative thematic analysis approach was used to analyze the data. results: the findings revealed that . % of the participants had heard about the disease covid- and realized common modes of transmission. some participants linked the disease with resentment of god on people or anger of god towards human kind. importance of consuming hot drinks, ginger or garlic to prevent the disease was reported by participants. negative attitude towards quarantine and isolation centers and stigmatizing people with a cough were documented in this assessment. stigma and fear of isolation centers may prevent people from reporting the symptom of the disease and this can create favorable ground for the transmission. challenges like problem of consistent availability of water supply, affordability of materials used to keep hygiene by rural poor, and keeping physical distancing in different public gathering places were reported. conclusion: concerned bodies need to address gaps in public awareness by providing health education and continuous awareness creation. the novel corona virus disease (covid- ) is an infectious disease caused by a novel corona virus now called severe acute respiratory syndrome corona virus (sars-cov- ) and can be transmitted from person to person via contact with respiratory droplets. the novel corona virus disease (covid- ) presents an important and urgent threat to global health. since the outbreak in early december in the hubei province of the people's republic of china, the number of patients confirmed to have the disease and deaths from it increased at an alarming rate through time. it was initially reported to the world health organization (who) on december , . on january , , the who declared the covid- outbreak a global health emergency. on march , , the who declared covid- a global pandemic. [ ] [ ] [ ] despite public health responses aimed at containing the disease and delaying the spread, several countries have been confronted with a critical care crisis, and more countries will almost certainly follow. major prevention methods recommended by the who include; regularly and thoroughly clean hands with an alcohol-based hand rub or wash them with soap and water, maintaining social/physical distancing, avoid touching eyes, nose and mouth, and different protection measures based on the situations. it's very well known that the covid- outbreak has placed unprecedented demands on the health systems of many countries around the globe. this is expected to get even worse in the middle-and low-income countries where the health system is weak and fragile. in countries that are hardest hit, health facilities and workforce are currently swamped by activities related to controlling the pandemic. as a step for the preparation to respond to the covid- pandemic, african countries have established a taskforce for corona virus preparedness and response (aftcon) that works in tandem with the african union commission, africa centers for disease control and prevention. in line with this and as a member state of the african union, ethiopian's preparedness and the health system's capacity to respond to the covid- is no exception. ethiopia reported the first case of covid- on march , . the trend shows a dramatic increase in the number cases with more indications of transmission in the community especially in the capital, addis ababa. in ethiopia, four months after the announcement of the first case, covid- cases had been identified by july . while the number of cases that recovered from the disease was % ( ), the number of people who died due to covid- was (case fatality rate of . deaths per cases. the government of ethiopia has taken several measures such as shutting down of schools including universities, restricting the movement of people under a state of emergency (stay at home), introducing chains of training programs for health workers, identifying isolation areas and hospitalization sites, starting screening tests at bole international airport and different engagement in mobilizing resources including equipment, supplies, food, money and educating the people about the disease and preventive methods, and so on. in this covid- pandemic, in addition to other interventions, timely access to accurate information and public awareness on prevention methods can be the difference between life and death. the stakes are high in developing countries like ethiopia where millions of people have limited access to information because of low media access, insufficient internet penetration, illiteracy, and so on. in this pandemic, when everyone should be aware of the risks posed by covid- and, most importantly, be informed about how to protect themselves and their families and societies at large. currently, as part of a national effort, wolaita sodo university has been engaged in different intervention packages concerning the response to the covid- pandemic. one of the activities is public education and information dissemination by using local media and other methods. but little is known about level of public awareness of the disease and its prevention methods. so, this assessment generates important information regarding the level of public awareness of the disease which in turn contributes to designing better mitigation strategies. hence this study was conducted to explore the level of awareness and prevention methods of covid- among residents of wolaita zone, southern ethiopia. the assessment was conducted in selected districts (woredas) of wolaita zone, southern ethiopia. residents from damot gale, boloso sore and humbo areas were included in this study. a qualitative study with a descriptive qualitative approach was used. this method is a naturalistic inquiry and it is the method of choice for this assessment since straight description of an event or phenomenon is needed. community members engaged in the transport service, shopping, market places, hotels and cafeterias, governmental and non-governmental organizations and religious organizations were selected purposively. maximum variation sampling was used. maximum variation sampling is a type of purposive sampling by which the participants view on a specific topic amongst different types of groups will be explored. a total of study participants, who were engaged in different service sectors in selected assessment areas, were submit your manuscript | www.dovepress.com risk management and healthcare policy : included. the service areas addressed in the assessment were; civil servants ( ), traditional coffee (jebena buna) ( ), religious leaders ( ), motorbike drivers ( ), trade in market areas ( ), hotels ( ), barbers ( ) and shops/supermarkets ( ) . in-depth interview (idi) was chosen as the data collection method to capture awareness and practices related to covid- by using an interview guide. the interview guide mainly includes, brief socio-demographic characteristics, awareness and prevention methods of covid- and possible suggestions to tackle the pandemic. this method is useful to have as each participant has an opportunity to share feelings, perspectives, and experiences concerning the problem. a semi-structured interview guide which included socio-demographic components, awareness and prevention aspects of covid- was used to collect data. data collectors were health professionals with past experience and oriented on the study overview, objectives, participant selection, tool review and interview approach. the interview was audio-recorded by using a recorder. interview data were reviewed periodically during data collection until data saturation was reached, according to the judgment of the research team. audio records were transcribed and translated into english and imported in to opencode version . . a qualitative thematic approach was used to analyze the data. data coding was done in each category by using the software. once coding was complete, a code report was produced for each code, cleaned and prepared for synthesis. during synthesis and write up, meaning units were identified in relation to the aim of the study. emerging meaning units that were extracted from each topic of the analysis were coded and then combined together to form categories, depending on their differences and similarities. potentially eligible and interested participants received consent forms in their local language and were informed that their participation would be voluntary and there would be no personal consequences or benefits to participation. informed written consent was obtained from all participants. confidentiality and anonymity was maintained when quoting research participants and the participants confirmed their agreement on publishing their anonymised quotes. this study complied with the declaration of helsinki. written informed consent was obtained from the participants and a declaration of signed consent include the statement: i have read or had read to me the information sheet that explains the reasons for the study, and all about the group discussion that i am being asked to participate in, all the questions i had about the study have been answered. i clearly understand what is being asked of me if i agree to participate in this study. i also know that i have the right to leave the study at any time if i do not want to continue. i am aware that all the information that i give will be kept confidential. i agree and confirm my agreement on publishing anonymized quotes and take part in this study and i put my signature. this study was reviewed and approved by the research ethics committee of the college of health sciences and medicine, wolaita sodo university, ethiopia. letters of support were secured by the research team from all institutions and offices where data were collected. major thematic areas considered during analysis were awareness towards the disease, prevention methods and challenges and suggestions to mitigate the pandemic in local context and presented as follows. most of the participants, ( . %), included in this study were males and the mean age of the service providers is years old (table ) . participants of idis were asked, regarding the disease covid- , about its cause and common symptoms. accordingly, of participants indicated that covid- is a new disease which happened recently, affecting all people in all countries in the world, transmitted from person to person and caused by virus. participants obtained information about the disease from different sources; common sources of information mentioned by the participants include; radio, television, social media, health care workers, telecom messages during outgoing call, religious leaders and friends/neighbors. four of the participants linked the disease with resentment of god on people and some others had a confusion with the term zoonotic disease. one of the participants who is barber explained the disease as follows; as i heard from media, radio, tv, religious institutions and mobile health educators, it is a virus which is deadly and has no treatment that transmits from person to person through breathing or by air during coughing. it is affecting another participant from another area, who is engaged in hotel management service said; i heard the information from media and people talking about a disease called corona virus which i have not ever heard. i know that there is no detected case in our area but based on the information from media, cases are detected in other countries and addis ababa only in our country. since then, i am practicing the messages told by health professionals for prevention from the disease acquisition. (male participant, aged ) two of the participants noted that the disease is the result of the anger of god since people do not obey the rule of god and one of the participants who is a "bajaj" driver explained that; what i know is, it is the disease that came from god as result of our bad and evil acts, it has no drug to treat and the only option is pray to god to be protected from this type of disease. (male participant, aged ) another participant from another site similarly noted that the disease emerged by the order of god and he shared the above idea by saying; i believe that, corona virus disease came from god because of our sin and we should pray to alleviate the problem and we should try to fight it by using all possible methods. (male participant, aged ) a participant from a similar woreda emphasized to follow all the instructions from the government despite his strong belief in god for the reason of the emergence of the disease as well as solutions for it and noted the situation as follows; i recommend all people should kneel down for repentance. so far there are many evil acts we did, disobedience, homosexuality, genocide, ethnic targeted displacement, corruption, robbery and so many unethical acts. so, we have to ask forgiveness of god along with precautions from government. (male participant, aged ) one of the participants, who is civil servant in his occupation, said that "it is confusing for me whether this disease can be transmitted from animal to human through eating animal products like raw meat since there are recommendations that avoid consuming raw meat." this idea was shared by another participant from another woreda and he pinpointed the situation as follows; " . . . the disease can be transmitted via raw meat consumption so i think there is a possibility of acquiring it from animals" (male participant, aged ), participants of the assessment were asked to reflect their opinion on common symptoms and modes of transmission of covid- ; accordingly they forwarded their perspectives on symptoms of the disease and modes of transmission. cough, fever, sneezing, diarrhea, throat pain, difficulty breathing and head ache were common symptoms of the disease mentioned by several participants. based on the review of transcripts, participants indicated different modes of transmission of covid- , namely; hand shaking, hugging, sitting together, contact with droplets during coughing and sneezing, making contact with infected air and objects, skin penetration, and sharing clothes. concerning modes of transmission, one of the participants said; the virus can be transmitted through contact, sneezing droplets, when we are sharing clothes with others, hand shaking, when we talking there are small droplets they may transmit disease, when we are close each other or sit together. these are the ways of transmissions. (female participant, aged ) droplet inhalation and contact with the droplet was pinpointed by another participant and he said; corona virus is a disease that can be transmitted from person to person via contact and also individuals might contract this virus through droplet inhalation. in addition to this, if a person touch different materials that might have come in touch with the virus, it favors the virus transmission in the developed countries and now a days, has also been health problem in ethiopia. (male participant, aged ) based on the transcripts of interviews, some participants emphasized that the virus can be transmitted via skin penetration after hand shaking or making contact with an infected person. a bajaj driver from one of study woredas said; if we don't wash our hands, the virus can enter our body through penetration of skin of our hands. (male participant, aged ) the above concern was shared by another participant from the same town and he further elaborated the issue as follows; . . . at the time of hand shaking with the infected individual, uninfected individual can easily acquire the virus and at the same time it enters in to the body by penetrating hand, because it is very dangerous virus. (male participant, aged ) hand washing, avoiding hand shaking, wearing masks and gloves, using sanitizer, physical distancing, general personal hygiene, holy water, consuming hot drinks, chili papers, garlic and ginger were identified as prevention methods of the disease by participants of in-depth interview. according to the in-depth interview participants, hygiene was described in different ways namely; washing hands every minutes, taking showers five times per week, washing hands three times per day and using sanitizer, soap and water together. two participants assumed the fever screening as a final technique that declares their status and feel a sense of security. negative perception towards quarantine and isolation center was indicated by some of the participants. the following quotes describe different views as follows; as health professionals have been telling us washing hands every minutes, rubbing with alcohol, avoid hand shaking, making physical distance at least meter. (male participant, aged ) to prevent disease, keeping social distancing, we have been practicing social distancing in funeral areas yesterday as well as the day before yesterday. there were professionals coordinating this. another is minimizing social life. very important way is washing hand frequently. using masks, wearing gloves in the office is important since we are collecting revenues. avoiding hand shaking is another method. (female participant, aged ) a religious leader has briefed the importance of holy water to prevent the disease together with other precautions and he said; we make members to sit far apart, we order them to wash their hands and they use holy water without sharing drinking materials and i believe this is helpful to prevent the disease. (religious leader, male, aged ) risk management and healthcare policy : submit your manuscript | www.dovepress.com based on a participant response, hot drinks and homemade prevention options were key to prevent covid- . she described by her own word as follows; . . . this disease has come from foreign countries, we are ordered to pray god in churches, in addition we are using spices and herbs like garlic, ginger, chili papers and hot drinks which are important to prevent this infection. (female participant, aged ) based on the explanation of a participant, one time screening was considered as an adequate method to prevent the disease and he explained the issue as follows; . . . i don't know about it in detail but to prevent the disease as it has no drug, for myself i got tested for the disease while i was coming from shashemene, as i knew my status there is no problem but i want to teach others to get tested for the disease. (male participant, aged ) a participant described how they changed their usual office set up and trend in order to prevent the disease, she explained the situation as follows; in our office, our work has forces us to have frequent interaction with the people since we are collecting revenues. another thing that poses risk is money that we are collecting. we can't lock the job; because the revenue and tax that we collect is necessary for salary and other payments. with us there is finger print machine. since many people are touching it may transmit the disease. therefore we clean machine with alcohol after everyone is recording finger print and we are making the customers who use machine to rub their hands with alcohol. another is; we have hand washing corner at the gate. therefore everyone washes his/her hand before getting in to office. we serve the customer through window. we don't allow them to enter to the rooms. (female participant, aged ) participants noted challenges like consistent availability of water, affordability of materials used to keep hygiene for the rural poor, keeping physical distancing in funeral area and markets, lack of awareness (particularly in rural areas), difficulty of avoiding usual trend of greetings like hand shaking in rural areas, not obeying rules and instructions, misunderstanding on lifting of some of the restrictions like allowing motorbike movement, stigmatizing people with cough. in this study, the participants were also asked for any comments and suggestions on the ways of preventing the pandemic by overcoming the challenges and minimizing its burden. the major suggestions forwarded by the participants include; continuous awareness creation, law enforcement and providing support for poor people. the following quotes describe different views and suggestions as follows; still people are shaking hands each other in rural area, for example today it is market day, if someone caught by the disease, disease my spread to everyone. people salute each other while selling animals. they kiss each other's hand, to show their agreement for selling. therefore, it is good to teach the community continuously. (male participant, aged ) it is difficult to prevent this disease in our area. for example motorbikes carries two or more customers at a time, they do not respect the rule. at rural area; people have no awareness about the disease. they don't know even as the disease is killer. therefore, there should be intense teaching. still there is gathering, sitting together. there should be continuous teaching. (male participant, aged ) there is shortage of soap; food ingredients are expensive and not affordable for poor people. therefore, government should try to provide the supplies to the poor either as donation or by affordable price. (female participant, aged ) government should force the community. for instance; motor vehicle ordered to use by maximum of two persons at a time. but they not obey this. bajaj's do not obey too. therefore they should be forced to obey the rule. care should be taken in market areas and other gathering areas too. this is all that i can say. (male participant, aged ) . . . as i saw a great gap from both the government and the people. for example: majority of our people lives in the rural area but they have very little information about the disease so the government must address every kebele and each home. in addition to that as you know a lot of people are very poor and they obtain their expense from day to day activity so the government must support those in need. (male participant, aged ) sometimes peoples are not happy when you ignore hand shaking, they became emotional and respond aggressively. most of the time they said you didn't believe in god that is why you develop fear for the disease he protects us. so, this need attention. on the other hand, there is no enough water for hand washing in every part of the city it is limited to some special areas that may contribute for the spread of the disease. the most important thing that must need attention was people living in the rural area because there is no or little information about the virus because they lack mass media but majority of people are there, so the government must address this problem. in addition to this almost all the materials needed for protective purpose are in a very small amount or not at all. please as you said you are coming from university please try to solve this scarcity. (female participant, aged ) this quick assessment aimed to explore the level of awareness and prevention methods of covid- among residents of wolaita zone, southern ethiopia. the participants were civil servants, religious leaders, motorbike/bajaj drivers, merchants, hotel/café workers, barbers and people working in shops/supermarkets. the findings revealed that almost all of the participants heard about the disease covid- and based on their expression it is viral disease affecting everybody in all countries in the world and transmitted from person to person. some participants linked the disease with resentment of god on people and they strongly believe in praying to god to be protected from the disease. the implication of this finding is, it is still essential to provide necessary education for the community in order not to neglect all necessary prevention methods of the disease while praying to god which is well recognized by ethiopian government and currently it is included in the national television broadcasting program. some others had confusion with whether the disease is transmitted from animal to human because of advice like avoiding raw meat and other raw products. this shows the need for detail while educating people about the disease. findings from this assessment showed that most participants realized common modes of transmission of the disease, like contact with droplets during coughing and sneezing, making contact with infected air and objects via hands and so on, but some participants considered that the disease can be transmitted via skin penetration and this is also an important area that should be addressed during the education program. the assessment reveals that most participants got information from different sources and they had awareness of common symptoms of covid- . the findings showed several participants mentioned methods of prevention of the disease as per the recommendations by the world health organization (who) but some of the participants rely on consuming hot drinks, ginger or garlic to prevent the disease and giving them a sense of security, and this needs a precaution since these things are not scientifically proven prevention methods for covid- so far. in addition, issues like negative attitudes towards quarantine and isolation centers, stigmatizing people with a cough, considering screening by measuring temperature as a final result of their covid- status were documented in this assessment. so, it is helpful to consider these points during awareness creation and health education to mitigate the pandemic since issues like stigma and fear of isolation centers may prevent people from reporting the symptoms of the disease and this can create favorable grounds for the transmission. to ensure credibility of the findings in this study, data collectors who are very familiar with the study area were selected and trained. dependability refers to whether the findings of this study may be repeated in other places by other researchers and the study tools are available on request for others to do, consistently. transferability is the term used to refer to the external validity in qualitative studies, the study addressed different areas of the zone and service sectors and the finding is applicable in similar socio-cultural settings. this assessment has some limitations. although the study sites were drawn from different districts of the wolaita zone, the relative numbers of recruitment locations within these districts were few and not necessarily representative of the entire rural community. the overall number of respondents, though limited by available resources and time, was in line with similar qualitative quick assessments of this type. generally, most of the interviewed participants indicated that covid- is a newly emerged viral disease, affecting all people in all countries in the world, transmitted from person to person. some participants linked the disease with the anger of god on people and some others had confusion with zoonotic diseases. most participants mentioned common symptoms of the disease. participants indicated different modes of transmission of covid- , explicitly; hand shaking, hugging, sitting together, contact with droplets during coughing and sneezing, making contact with infected air and objects, skin penetration, and sharing clothes. hand washing, avoiding hand shaking, wearing masks and gloves, using sanitizer, physical distancing, general risk management and healthcare policy : submit your manuscript | www.dovepress.com dovepress personal hygiene, holy water, consuming hot drinks, chili papers, garlic and ginger were identified as prevention methods of the disease by participants of the in-depth interview. some participants assumed that screening by measuring temperature as a final technique that declares their status and felt a sense of security. negative perception towards quarantine and isolation centers was indicated by some of the participants. participants noted challenges like problems of consistent availability of water, affordability of materials used to keep hygienic by the rural poor, keeping physical distancing in funeral areas and markets, lack of awareness (particularly in rural areas), difficulty in avoiding the usual trend of greetings like hand shaking in rural areas, not obeying rules and instructions, misunderstanding on lifting of some of the restrictions like allowing motorbike movement and stigmatizing people with a cough. it is recommended to provide continuous awareness creation, community mobilization and strong law enforcement in some areas, like the transport sector. a local covid- prevention taskforce should regularly attend events like funerals and markets to facilitate physical/social distancing (this may include health care workers, religious leaders, community leaders, security and so on). novel coronavirus who declares public health emergency for novel coronavirus declares global emergency as wuhan coronavirus spreads:the new york times declares pandemic as number of infected countries grows. the new york times covid- ), who advice for the public lancet glob health novel coronavirus ( -ncove) reminiscent of spanish flu: a challenge to global public health systems (editorial) federal democratic republic of ethiopia, ministry of health the significance of saturation we would like to acknowledge the zonal health department and local administrations, without whose cooperation this assessment would have been impossible. study participants deserve special acknowledgment for all their cooperation in the data collection process and for providing genuine information that resulted in the accomplishment of this assessment. the authors report no conflicts of interest for this work. risk management and healthcare policy is an international, peerreviewed, open access journal focusing on all aspects of public health, policy, and preventative measures to promote good health and improve morbidity and mortality in the population. the journal welcomes submitted papers covering original research, basic science, clinical & epidemiological studies, reviews and evaluations, guidelines, expert opinion and commentary, case reports and extended reports. the manuscript management system is completely online and includes a very quick and fair peer-review system, which is all easy to use. visit http://www.dovepress.com/testimonials.php to read real quotes from published authors. key: cord- -ptkw csu authors: gilbert, gwendolyn l.; kerridge, ian title: the politics and ethics of hospital infection prevention and control: a qualitative case study of senior clinicians’ perceptions of professional and cultural factors that influence doctors’ attitudes and practices in a large australian hospital date: - - journal: bmc health serv res doi: . /s - - -y sha: doc_id: cord_uid: ptkw csu background: hospital infection prevention and control (ipc) programs are designed to minimise rates of preventable healthcare-associated infection (hai) and acquisition of multidrug resistant organisms, which are among the commonest adverse effects of hospitalisation. failures of hospital ipc in recent years have led to nosocomial and community outbreaks of emerging infections, causing preventable deaths and social disruption. therefore, effective ipc programs are essential, but can be difficult to sustain in busy clinical environments. healthcare workers’ adherence to routine ipc practices is often suboptimal, but there is evidence that doctors, as a group, are consistently less compliant than nurses. this is significant because doctors’ behaviours disproportionately influence those of other staff and their peripatetic practice provides more opportunities for pathogen transmission. a better understanding of what drives doctors’ ipc practices will contribute to development of new strategies to improve ipc, overall. methods: this qualitative case study involved in-depth interviews with senior clinicians and clinician-managers/directors ( doctors and nurses) from a broad range of specialties, in a large australian tertiary hospital, to explore their perceptions of professional and cultural factors that influence doctors’ ipc practices, using thematic analysis of data. results: professional/clinical autonomy; leadership and role modelling; uncertainty about the importance of hais and doctors’ responsibilities for preventing them; and lack of clarity about senior consultants’ obligations emerged as major themes. participants described marked variation in practices between individual doctors, influenced by, inter alia, doctors’ own assessment of patients’ infection risk and their beliefs about the efficacy of ipc policies. participants believed that most doctors recognise the significance of hais and choose to [mostly] observe organisational ipc policies, but a minority show apparent contempt for accepted rules, disrespect for colleagues who adhere to, or are expected to enforce, them and indifference to patients whose care is compromised. conclusions: failure of healthcare and professional organisations to address doctors’ poor ipc practices and unprofessional behaviour, more generally, threatens patient safety and staff morale and undermines efforts to minimise the risks of dangerous nosocomial infection. in high income countries, an estimated - % of hospital inpatients develop healthcare-associated infections (hais) [ ] and nosocomial transmission of multidrug resistant organisms (mrdo) is a major contributor to antimicrobial resistance (amr) and its associated healthcare costs [ , ] . it is estimated that - %, or more, of hais are preventable [ , ] , although rates are highly variable, depending on how effectively ipc measures are implemented [ , ] . failures of routine hospital infection prevention and control (ipc) practices, in high income countries during this century, have resulted in devastating nosocomial outbreaks of exotic or emerging infections, such as severe acute respiratory syndrome (sars) in toronto, in [ ] and middle east respiratory syndrome (mers) in seoul in [ ] , causing preventable deaths and massive social and economic disruption. hand hygiene is the most obvious, easily audited and, arguably, the most effective ipc practice [ , ] , its efficacy has been recognised since at least the mid-nineteenth century, with numerous studies showing that significant reductions in pathogen transmission and hai rates are temporally associated with improved hand hygiene compliance [ ] . nevertheless, the use of hand hygiene as a surrogate for ipc quality and the moral status of noncompliance have been questioned, largely as a consequence of ongoing controversy about auditing methods and plausible compliance targets [ ] [ ] [ ] . ethical considerations have particular salience in light of numerous studies reporting lower than average compliance with ipc policies among doctors, compared with other health professionals, albeit with wide variation [ ] [ ] [ ] . doctors' attitudes and behaviours are important, because they disproportionately influence those of other hospital staff and doctors often overestimate their own knowledge and compliance [ , ] . yet their peripatetic clinical practice provides numerous opportunities to transmit pathogens [ ] and to be pathogen "super-spreaders" [ , ] . doctors retain considerable professional autonomy and power, despite repeated challenges from increased regulation, other health professions, evidence-based medicine and consumerism [ ] [ ] [ ] . despite recent attempts to redefine "medical professionalism", a universally agreed definition remains elusive; but all versions include common commitments to e.g. patient welfare; maintenance of knowledge and skills; and securing public trust through professional self-regulation and avoidance of conflicts of interest [ ] [ ] [ ] . how doctors interpret these commitments depends on how they perceive their professional identity [ ] . in practice, their attitudes and practices are complex and sometimes perplexing. assuming that patient welfare is doctors' highest priority [ ] , one may reasonably ask why some would expose their patients to preventable infection risks by failing to observe well-established ipc rules [ , ] ? previous qualitative and mixed methods studies of factors that affect adherence to ipc practices have generally involved mixed groups of healthcare workers and/or focused on particular institutional settings, such as intensive care units. while these studies have identified factors that contribute to ipc practices including: self-protection, role modelling, belief (or not) in the effectiveness of ipc, knowledge, communication and workload [ , , , ] they have not, for the most part, explained why these factors are so influential. the aim of this study was to explore what factors affect doctors' ipc practices and, more specifically, why they are so influential. it took the form of in-depth conversations between researchers and participants, all of whom were senior clinical leaders and or clinician-director/managers with many years' experience. our expectation was that the perspectives of both "insiders" [senior doctors] and more objective "outsiders" [senior nurses] would provide new insights to inform strategies to raise the priority of ipc within the medical community and limit harm from hais and amr more effectively. our research question was: what professional and cultural factors influence doctors' attitudes to and practice of infection prevention and control? both researchers are senior physicians, one female, one male. our special interest in hospital ipc stems from longstanding experience in caring for patients who are at high risk, have suffered and, in some cases, died, from preventable hais and/or have experienced the uncertainty and fear associated with being colonised by a mdro. both of us were employed, for many years before or during this study, at the hospital where it was conducted. most of the participants were known to at least one of us, as colleagues, but with few exceptions, we had not worked closely with them. our aim was to build a rich portrait of doctors' attitudes to and practice of ipc, in one large australian tertiary hospital, by means of in-depth interviews with experienced senior doctors and nurses. together with them, we hoped to formulate new theories to better explain the reasons behind doctors' ipc practices, in order to develop more effective and generalisable strategies to improve them. we used a thematic analysis approach to data analysis [ ] . participants were senior doctors (i.e. medical practitioners) and nurses with varied clinical and/or management responsibilities, who were purposively selected as being likely to have a broad perspective on the attitudes, beliefs and practices of the hospital's medical staff across age-groups and specialties. invitations were sent by email, explaining the purpose of the study. thirty-two potential participants - doctors and nurses -were contacted sequentially. all of the nurses and doctors agreed to participate; two doctors were unavailable, one refused and three did not respond. sixteen participants were facility/divisional directors or unit managers, were specialist consultants; they had had - years' professional experience and most had been employed in the hospital for more than years. doctors were either full-time staff specialists [ss] or visiting medical officers (vmos) contracted on a sessional basis. nurses were all full-time employees. participant characteristics are summarised in table . the setting was a~ -bed university teaching hospital, serving a population of about . million in sydney and providing a broad range of tertiary specialist services to more than , inpatients, annually. the study was conducted at a single site to enable a rich and detailed understanding of the influences on doctors ipc practices and to avoid potential confounding effects of different policies, patient populations or physical environments. semi-structured interviews, lasting - min, were conducted by one researcher. they took the form of frank conversations between colleagues. most were conducted in the participant's -or occasionally the interviewer's -office with no-one else present. interviews were recorded and digitally transcribed by a professional transcription service, with participants' informed consent. examples of questions used to prompt discussion are shown in table . interview transcripts were checked for accuracy by one researcher. both authors reviewed the transcripts, coded them manually and analysed them thematically [ ] , to identify themes and subthemes relevant to the research question. after initial analysis, transcripts and emergent themes/subthemes were reviewed, iteratively, and modified after further discussion. recruitment ceased when data saturation had been reached. participants gave written informed consent to interviews being recorded and transcribed. they were assured that their comments would be confidential and quoted, if at all, only after removal of identifying information. in describing our findings, we identified participants' professions and roles, broadly, to preserve anonymity, as nursing director (nd), manager (nm) or consultant (nc); or medical director (md) or consultant (mc). the relevant local health district human research ethics committee approved the study. four major themes emerged from the data and, within theme , four subthemes were identified. these themes and subthemes are outlined in table . theme is the subject of this paper. other themes/subthemes will be discussed, in detail, elsewhere. you can't tell doctors what to do (medical director [md] ). doctors' highly valued clinical autonomy was seen as one of the most important determinants of ipc practices. participants described doctors, generally, as self-motivated and averse to being told what to do, particularly as they become more senior. this was attributed to: the types of people who become doctors; doctors' perception that others expect them to be confident and decisive; and their tendency to rely on clinical judgment and experience, rather than "rules". however, participants described differences in how doctors enact clinical autonomy in their ipc practices. those of some individual doctors and unitsrepresenting such varied specialties as transplantation surgery, haematology, general surgery and neurosurgerywere described, by participants, as exemplary. a unit director (md ) recounted his own unit's practice, of having a junior doctor audit the team's hand hygiene compliance and present the results at weekly meetings, and his pride in the resulting improvement. at the other extreme, several participantsindependently -cited examples of units in which ipc standards were notoriously poor and hai rates (reputedly) excessive; they also described individual consultants who had to be reminded, repeatedly, about basic ipc precautions and who vehemently demurred, refused or tried to avoid situations where they may be asked, to comply: from a political point of view, we (intensive care unit [icu] clinicians) are in a bind. we encourage outside (surgical) teams to see their high-risk patients daily, (but) they're saying "i don't want to go to icu, they always give me a hard time about washing my hands or taking my jacket off". so, we're trying to make sure that they have easy access to the patients, but in such a way that the whole process is smooth. for some clinicians, hand hygiene presents an objectionable obstacle. (emphasis added) (md ) several (doctor) participants thought their colleagues' objections, to ipc "rules" that they perceived to be inflexible, inappropriately applied or imposed by outsiders, were legitimate. for example, patients being placed in contact isolation, when the risk of cross-infection was minimal, caused increased pressure on already over-burdened junior doctors and potentially endangered other patients, because of misplaced priorities. the infection control nursing staff don't understand the pressures that medical staff, particularly junior medical staff, are under. some of the attitudes to infection control appear to be given in isolation without really an understanding of how they might be integrated into all the various things that have to be done by residents and senior doctors and nurses. a bit of an irritant is if i'm asked to take precautions that i don't think are appropriate (when) nursing staff have instituted a policy (and) gone a bit too far. (for example) a patient who has minor neutropenia and a (mild) fever that you're keeping in just in case.... they're given priority, put in a single room and everybody's in gloves and gowns; and they've got other people out in the ward coughing and hacking, perhaps harbouring something much more significant. (md ) several medical directors attributed doctors' poor ipc practices to ignorance, although on-line ipc training and attendance at education sessions was supposedly mandatory. there's a poor understanding of what's required, even though you're meant to do mandatory training. but apparent adherence to ipc principles sometimes reflected tradition or habituated behaviour, rather than knowledge of organisational policies. a surgeon contrasted his colleagues' almost ritualistic "surgical scrubbing" and donning of theatre attire in the operating theatre, with cursory adherence to standard ipc precautions in the wards: participants emphasised the importance of leadership in moulding the ipc practices of junior doctors, who are likely to emulate those of senior consultants. they characterised good ipc leaders as consistently adhering to good practices, themselves, and being willing to discuss ipc principles and review practices and outcomes with their teams (see md 's anecdote about registrar hand hygiene audits, above, and unit x director's response to his patients' hais below). of course, clinical leadership is about much more than ipc practices: i often talk about (a particular surgical unit) because they are a high performing team and their leadership is very strong across the board in all sorts of areas; they're very solid as a team and the interns know the rules and abide by them even when (the consultants) are not there. (nd ) on the other hand, bad or absent leadership is often also associated with poor ipc practice. if the "boss" ignores or disparages ipc practices, junior doctors would follow suit. it's about leadership and followership. senior staff 's lack of role modelling -automatically the followers see that "it's not a big deal for sir, so it's not a big deal for me". (md ) one participant wondered whether leadership and role modelling might be less critical, now that junior doctors were increasingly aware of the importance of ipc and could influence consultants' ipc behaviours, by reminding them of the policies. the more prevalent view was that the (still) powerful medical hierarchy was a strong deterrent against any attempt to correct the "boss", even implicitly, for fear of retribution. where a junior person speaks to a more senior person (about) a protocol that hasn't been performed correctly, the senior person feels threatened. the normal thing is to stamp your authority and say "well hang on, who are you?". (mc ) most participants felt that any good habits learnt in medical school were likely to be superseded by hidden curricula assimilated during postgraduate training. doctor participants admitted that they would not personally feel comfortable speaking to senior colleagues about poor ipc practices; on the other hand, some nurse participants said they would willingly speak up to a consultant or team with whom they had a good working relationship. participants acknowledged the devastating effects, on patients, of serious hais, but pointed out that most doctors personally manage such complications infrequently and hear about only the worst cases at morbidity and mortality (m&m) meetings. many doctors have little appreciation of the incidence, or impact on patients, of more minor infections. moreover, hais are often regarded as unavoidable; they are rarely attributable to specific actions, omissions or even patterns of behaviour, because of the inevitable delay and multiple factors and people involved. nevertheless, participants described doctors' contrasting reactions to their own patients' hais: one saw it as a disaster, for which he felt personally responsible, another as a driver for change. a nurse manager described starkly contrasting attitudes between two unit directors: (unit x's director says) "what did we do wrong: what are we going to do to make sure this doesn't happen (again)?" he doesn't want to see bad things happen to patients. (unit y's director at the departmental m&m meeting) … . it's: "what's the patient done wrong this time? it's the patient's fault. it's not our fault. the patient's dirty (or) too fat; they should have looked after themselves better". there's no accountability, no insight. (nm ) several participants noted that hais are often overlooked because of inadequate patient follow-up; they were highly critical of some senior consultants' infrequent ward rounds, expectation that trainees would manage and follow-up patients, often with minimal supervision, and apparent lack of interest in patient outcomes. somebody who swans in, looks at something, swans out again and never understands that what he actually did was screwed up the patient's life -that's the problem. interviewer: what can you do about it? participant: throw their noses in the data. (md ) unfortunately, for most departments, very limited data are available. collection of unit-specific hai data was seen as the organisation's, not individual unit's, responsibility. while participants noted that monthly hand hygiene audit data were posted on ward notice boards, they believed that medical teams rarely reviewed them or, if they did, were skeptical about their accuracy and unaware of how they compared with those of other wards. one medical director (md ) acknowledged that ward compliance data showed large discrepancies between wards and the lowest compliance rates amongst doctors, which were masked by the hospitals' satisfactory results, overall. another director (md ) suggested that audit results overestimate actual compliance because auditors were not strict enough, but he rationalised doctors' relatively low rates as being due to the fact that the auditors were nurses. in answer to an open question about general issues of concern, all medical divisional directors mentioned their frustration at some senior consultants' apparent lack of commitment to their public hospital responsibilities, because of the demands or attractions of private practice. [they] ... come in, do an operation, bugger off. they probably won't ever see that [public] patient again; they don't know what the outcome is. they don't have to front these patients in their office. [md ] participants attributed this to better remuneration, working conditions, infrastructure and capital equipment in the private sector. while noting that vmos value the prestige and challenging case-mix of a public hospital appointment, one director (md ) pointed out that their contracts do not stipulate specific obligations (that many would take for granted), such as teaching and supervision of junior staff or accountability for patient outcomes. he suggested that, rather than relying on vmos' "altruism", the public system should provide more attractive conditions. if you want the talent you've got pay for it -an adequate salary, medical indemnity, secretary, reasonable office, parking space. it's a very big package, but that's what you need to do. if you offered them that they would be prepared to take a or per cent cut in income to concentrate their activities in one place and give up all the angst of being an employer. (md ) while this solution seemed unlikely in the current public health system, a senior manager mentioned the hospital executive's plan to revise vmo contracts to define the "rules of engagement", to which applicants must agree, including regular attendance at ward rounds and teaching sessions, trainee supervision and formal delegation of decision-making at weekends. in common with many australian public hospitals, the case hospital's recent devolution of accountability for key performance indicators (kpis), to divisional directors, had made them more aware and less tolerant of consultants, whom they perceived to be failing their implicit obligations, with impunity. in the context of this study, they linked this behaviour to ignorance of ipc policies and poor practice. however, they all agreed that instigating disciplinary action against senior doctors, in these circumstances, would be professionally and legally difficult, divisive and bitterly opposed, on principle, by medical organisations and most doctors, including those whose own behavior was above reproach. none of the divisional directors could offer solutions, other than more explicit employment contracts and/or more pay, but they conceded that it would still be difficult to monitor or enforce compliance. despite their frustration, some directors described recent success, in delegating responsibility for clinical and administrative improvements, including in ipc, to unit directors, and assimilation of autonomous senior consultants into unit teams. while doctors' relatively poor ipc practices, overall, have been well-documented, this qualitative study is one of few which have deeply interrogated why this is so. participants regarded senior doctors' perceived entitlement to professional independence as a major contributor to how they choose to practice ipc and just one expression of how they fulfil implicit obligations to provide evidence-based patient care and clinical leadership. there was consensus that, although doctors are aware of the importance of ipc, for many it is not their highest priority. nevertheless, most observe ipc policiessometimes with modification -and/or do not object to being reminded. uncertainty about the efficacy of some ipc measures and a lack of data about hais are barriers to doctors' becoming more involved in ipc policy development and implementation. however, for most participants, the greatest concern was some senior consultants' hostile disregard for ipc policies and its adverse effects on patients and other staff and their apparent immunity from censure. participants regarded doctors as generally resistant to external rules, which they see as a challenge to their clinical autonomy and self-perception as independent thinkers [ ] . in relation to ipc they may exercise autonomy, either by taking it very seriously (exemplary practice) or by choosing to remain ignorant or dismissive of basic ipc precautions, which participants interpreted as evidence of a perceived entitlement to decide, for themselves, what is important. it has been shown, previously, that compliance with hand hygiene is inversely related to educational level and seniority [ ] . in making sense of this observation, we noted that many senior consultants completed their training and developed habituated behaviours at a time there was little focus on ipc, because of a prevalent belief that infectious diseases had largely disappeared [ ] . while this belief is now known to have been misguided, the fact that it persists could be interpreted as a failure of continuing professional education (cpe). although cpe is a condition of annual medical registration, in australia, it is largely confined to specialty topics. specialist colleges endorse, and expect members to comply with, ipc guidelines and online ipc training is mandatory for all hospital staff, but many senior doctors choose to ignore both, with impunity. college expectations and hospital requirements are futile if professional autonomy is interpreted as meaning that compliance is discretionary [ ] . previous studies have also suggested that doctors' poor compliance with guidelines, in general, reflects ignorance or skepticism about their effectiveness and/or an exaggerated confidence in their own judgment [ , ] . as charani et al suggest: senior doctors consider themselves exempt from following policy and practice, within a culture of perceived autonomous decision-making that relies more on personal knowledge and experience than formal policy [ ] . senior consultants for whom ipc is a high priority may, nevertheless, seek to selectively 'modify' hospital ipc policies. this observation is supported by a recent study [ ] that found that violations of transmission-based precautions were often not due to ignorance, but a clinicians' judgment that the risks did not justify the extra staff time and cost or adverse effects on patients [ ] . participants gave examples of such modifications, which they regarded as sometimes appropriate. however, they are likely to be interpreted as arbitrary and a source of confusion and conflict; they might be avoided if doctors were more willing to be involved in the development and local implementation of ipc policies, as leaders or champions [ , ] . doctors' apparent independence may be partly illusionary, if their clinical practice is guided by habituated behaviours, learnt during their early postgraduate training, by emulating teachers and supervisors, whom they admire or fear [ ] . participants identified leadership, as others have done [ ] , as an important determinant of (good or bad) ipc practice. within a hierarchical hospital system, leadership is usually based on seniority, status and power [ ] . most senior consultants exercise their leadership roles appropriately and model acceptable or exemplary ipc practices but the attitudes of the minority, who repeatedly ignore or dispute basic ipc precautions, will also be transferred to junior doctors. medical students are now taught about the importance of ipc and the risks of hai and amr but, as postgraduate trainees, they absorb the hidden curricula [ ] of the specialties and units in which they train, which may be at odds with what they have been taught. once entrenched, senior doctors' habituated behaviours are difficult to change, since even their peers are deterred, by professional etiquette and their own uncertainties, from challenging colleagues' unsafe practices [ ] . even doctors who are knowledgeable about and aware of the importance of ipc may struggle to understand how hais occur, because the effects of practice breaches are delayed, hidden and uncertain. some regard hais as unavoidable or someone else's fault -"the problem of many hands" [ ] -and many have little concept of patients' fears or the significant personal cost of even minor hais [ ] . these problems are compounded by lack of data. results of mandatory reporting to health authorities or internal incident reports of serious, but rare hai-related events, such as bloodstream infections or unplanned readmissions, have little resonance and there are virtually no data about less serious hais. so it is impossible to monitor trends or reflect on individual consultant's or unit's performances vis-à-vis their peers, despite evidence that surveillance and feedback of results can motivate ipc improvement and reduce hai rates [ , ] . the lack of consistent national hai surveillance, in australia, is a recognised barrier to sustained ipc behavior change, particularly among doctors, and state-or hospitalbased surveillance is highly variable [ ] . the perceived failure of a small proportion of consultants to meet their obligations to the public hospital system was the issue that our participants spoke about most vehemently. our participants felt strongly that senior doctors' infrequent presence in the hospital and poor trainee supervision, (public) patient follow-up and ipc practices were not valid expressions of professional autonomy and agency, but manifestations of disrespect both for patients, who are exposed to unnecessary risk and colleagues who conform with, or are responsible for maintaining, ipc standards. moreover, the hostile reactions of some doctors, to being reminded about basic ipc precautions, were interpreted as a manifestation of the bullying, which is endemic in healthcare settings in many countries, including australia [ , ] , and as 'yet another' failure of professional self-regulation [ ] . in this regard, recent media scrutiny of withdrawal of postgraduate training accreditation from two major sydney public hospitals, largely as a consequence of bullying and harassment by senior medical staff [ , ] , raises the question of whether hospital administrators and specialist colleges will act to address cultural problems in medicine, including bullying, more effectively. where to from here? the vanderbilt university medical centre's system of co-worker observation and reporting is one promising approach to doctors' (and others') unprofessional behaviours. it involves, as a first step, a suitably trained colleague initiating an informal, respectful conversation with a doctor whose behaviour has been the subject of complaint from a patient or co-worker. in most cases this is apparently sufficient but, if a pattern of behaviour emerges, it is followed by staged escalation [ ] . it has proven to be feasible and effective in reducing bullying [ ] , patient complaints [ ] and poor ipc practices [ ] and limits the need for more direct disciplinary action. it has been introduced or considered by several australian hospitals [ ] and the royal australasian college of surgeons [ ] . such an holistic approach to organisationwide culture change, would complement better surveillance and feed-back of hai-related data and innovative strategies, such as the use of video-reflexive methods that have been used successfully to raise clinician awareness and improve ipc practices [ ] . a major strength of this study was the seniority, varied clinical and management experience and broad vision of our participants, who were among the hospital's most senior clinicians and clinician-managers/directors. many of them were responsible for service quality and efficiency across multiple departments and acutely aware of the issues discussed. in addition, we believe that, because the interviewer was an "insider", with comparable seniority and professional background, participants shared their insights and frustrations more candidly than they may have done with an external researcher. as researchers, we were inevitably influenced by our own perspectives and biases, which we sought to mitigate by discussion and self-reflection and by consulting as broad as possible a range of participants. as typical of qualitative research, they were but a small sample of the larger cohort of senior hospital clinicians, but represented a wide range of specialties, seniority, management responsibilities and attitudes to ipc. the fact that participants and researchers were staff of a single hospital is appropriate for a case study but could also be seen as a limitation. however, our observations, experience and published literature suggest that the issues identified are common to most large, tertiary hospitals in australia and countries with similar mixed public/private health systems. moreover, limiting the study to a single site meant that all participants were familiar with the organisation's idiosyncrasies and illustrative examples of doctors' attitudes or practices were corroborated, and given added cogency, by multiple participants. while participants expressed their opinions, frankly, about the attitudes and behaviours of colleagues, they generally did not identify them except by specialty. we did not seek to corroborate opinions about ipc practices with objective evidence of compliance, which was not the focus of this study, and none of the few units mentioned by participants, as having poor ipc practices, was represented amongst participants. this was unintended but may be seen as a limitation. clearly many factors contribute to doctors' ipc practices, other than (and sometimes contrary to) the norms, values and precepts of the medical profession. one of the most salient is how they interpret professional autonomy, which is a strongly defended principle of medical professionalism, but surely not intended to imply that doctors are entitled to ignore the policies of their employer organisations. although participants sometimes defended doctors' objections to, or ignorance of ipc "rules", they clearly regarded doctors who reacted to reminders or requests to comply aggressively or unprofessionally, as an "out-group". in common with other preventive programs, ipc is sometimes a victim of its own (partial) success; there is a widespread but unsubstantiated impression that ipc practices are "good enough" and further improvements not cost-effective. however, the continuing prevalence of preventable hais and nosocomial transmission of mdros and the threat of emerging infections mean that sustained improvement is needed. we argue that this will not be achieved without the full support and participation of all healthcare professions, includingperhaps especiallydoctors. however, our findings suggest that improving doctors' ipc practices will require greater commitment from professional organisations and healthcare administrators to a) more appropriately measure, and inform clinicians about, the adverse effects for patients of non-adherence and b) effectively enforce appropriate policies and practices that prevent these harms. the poor ipc practices of some doctors are just one aspect of the broader issue of unprofessional behaviour and immunity from criticism that must be addressed, if the medical profession, in general, is to be seen to conform with its espoused professional values and those of the 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identification and characterization of failures in infectious agent transmission precaution practices in hospitals: a qualitative study contact precautions for endemic mrsa and vre: time to retire legal mandates the role of the champion in infection prevention: results from a multisite qualitative study. qual saf health care the importance of leadership in preventing healthcare-associated infection: results of a multisite qualitative study beyond curriculum reform: confronting medicine's hidden curriculum new' and distributed leadership in quality and safety in health care, or 'old' and hierarchical? an interview study with strategic stakeholders infections and interaction rituals in the organisation: clinician accounts of speaking up or remaining silent in the face of threats to patient safety patient safety and the problem of many hands involving patients in understanding hospital infection control using visual methods effectiveness of a nationwide nosocomial infection surveillance system for reducing nosocomial infections healthcare-associated infections in australia: tackling the 'known unknowns use of unsolicited patient observations to identify surgeons with increased risk for postoperative complications endemic unprofessional behaviour in health care: the mandate for a change in approach why is u.k. medicine no longer a selfregulating profession? the role of scandals involving "bad apple" doctors sydney hospital's cardiothoraacic surgery unit trainee ban over bullying: the sydney morning herald westmead hospital icu stripped of training accreditation over alleged bullying: the sydney morning herald a complementary approach to promoting professionalism: identifying, measuring, and addressing unprofessional behaviors using coworker observations to promote accountability for disrespectful and unsafe behaviors by physicians and advanced practice professionals an intervention model that promotes accountability: peer messengers and patient/family complaints sustained improvement in hand hygiene adherence: utilizing shared accountability and financial incentives royal melbourne hospital targets bullying with new cognitive institute program: the age building respect and improving patient safety an innovative approach to strengthening health professionals' infection control and limiting hospital-acquired infection: video-reflexive ethnography the authors wish to sincerely thank the senior clinicians who gave so generously of their time to participate in this study and emeritus professor miles little, dr. suyin hor and dr. julie mooney-somers for helpful comments on early versions of this paper. this research received no funding. the datasets generated and/or analysed during the current study are not publicly available because participants did not give consent for interview transcripts to be published but (selected portions) are available from the corresponding author on reasonable request. authors' contributions glg developed the project concept, conducted interviews, reviewed, coded and analysed interview transcripts and wrote the first and subsequent drafts of the manuscript. ik contributed to conception and development of study design, reviewed and coded interview transcripts and contributed to editing of manuscripts drafts. both authors have approved the final version of the article.ethics approval and consent to participate this study was approved by the western sydney local health district human ethics research committee. all participants provided written informed consent to interviews being recorded and transcribed and quotes to be used in publications after removal of identifying information. the information sheet/consent form was approved by the ethics committee. participants were not asked and did not consent for transcripts to be published or for any personal identifying information to be made available other than their professional status (medical/nursing; director/manager/ consultant). quotes were selected to ensure that the source would not be identifiable. the authors declare that they have no competing interests. key: cord- - buh wm authors: kalichman, seth c.; eaton, lisa a.; berman, marcie; kalichman, moira o.; katner, harold; sam, soya s.; caliendo, angela m. title: intersecting pandemics: impact of sars-cov- (covid- ) protective behaviors on people living with hiv, atlanta, georgia date: - - journal: j acquir immune defic syndr doi: . /qai. sha: doc_id: cord_uid: buh wm covid- and its social responses threaten the health of people living with hiv. we conducted a rapid-response interview to assess covid- protective behaviors of people living with hiv and the impact of their responses on hiv-related health care. method: men and women living with hiv (n = ) aged – years participating in a longitudinal study of hiv treatment and care completed routine study measures and an assessment of covid- –related experiences. results: at baseline, most participants demonstrated hiv viremia, markers indicative of renal disorders, and biologically confirmed substance use. at follow-up, in the first month of responding to covid- , engaging in more social distancing behaviors was related to difficulty accessing food and medications and increased cancelation of health care appointments, both by self and providers. we observed antiretroviral therapy adherence had improved during the initial month of covid- response. conclusions: factors that may pose added risk for covid- severity were prevalent among people living with hiv, and those with greater risk factors did not practice more covid- protective behaviors. social distancing and other practices intended to mitigate the spread of covid- interfered with hiv care, and impeded access to food and medications, although an immediate adverse impact on medication adherence was not evident. these results suggest social responses to covid- adversely impacted the health care of people living with hiv, supporting continued monitoring to determine the long-term effects of co-occurring hiv and covid- pandemics. the sars-cov- pandemic has rapidly emerged as a significant threat to public health, with the greatest degree of morbidity and mortality occurring among the elderly and individuals with underlying chronic health conditions, including people with compromised immune systems. [ ] [ ] [ ] although the factors and combinations of underlying conditions that determine the severity of the sars-cov- disease (covid- ) are under investigation, immune system dysfunction and other co-occurring chronic conditions raise concerns for covid- severity. for people living with hiv, unsuppressed virus is the hallmark of hiv infection progression and may increase covid- severity. in addition, indicators of renal disease that are commonly observed with hiv infection can lead to more severe covid- outcomes. liu et al, for example, found that covid- severity is significantly greater in patients with urinary glucose and protein markers. furthermore, conditions of poverty, particularly poor nutrition resulting from food insecurity, can impede immune functioning. substance use also raises concerns for increased covid- severity. tobacco use, particularly cigarette smoking, is associated with covid- severity, and tobacco use may interact with other substances to further compromise the immune system. , alcohol and other drug use also suppresses immune responses, [ ] [ ] [ ] particularly among people living with hiv. along with underlying health conditions, substance use raises concerns for covid- morbidity and mortality in people living with hiv. high prevalence of substance use and co-occurring underlying health conditions have the potential to amplify the severity of covid- in people living with hiv. , the increased vulnerability for covid- severity in people living with hiv shines a light on the necessity of adopting covid- protective behaviors, avoiding public gatherings, reducing social contacts, and physical distancing. covid- protective behaviors were recommended in early march as some states (eg, california, washington, and new york) responded to the unfolding health crisis. by contrast and in the absence of a national covid- strategy, the state of georgia was late in response. on march , , the us government declared a national state of emergency, and on march , , the centers for disease control and prevention issued recommendations to avoid social gatherings. initial reports from hiv clinical settings indicated the potential for interruptions in essential hiv care services. concerns have also been raised that stay-at-home orders and physical distancing could exacerbate what is already a high prevalence of food insecurity among people living with hiv. here, we report the results of a rapid-response interview with men and women living with hiv in atlanta, ga, conducted at the start of the us covid- epidemic. there were diagnosed cases and deaths in the state of ga on march , , and , diagnosed cases and deaths month later. during the final week of data collection for the current study, the -day average number of covid- diagnoses in the state of georgia was greater than , and the average daily deaths was greater than . more than % of cases and % of deaths in georgia occurred in the atlanta metro area. the city of atlanta acted to issue orders for protective policies before the state government. on march , , the mayor of atlanta issued a state of emergency, and on march , , all nonessential businesses closed, which remained in effect throughout the data collection period. we examined social responses to covid- including physical distancing and reducing social contacts in response to the earliest public alerts. we specifically tested the association between covid- protective actions and their impact on hiv-related care and treatment. participants in the current study were men and women living with hiv in atlanta, ga, who were between the ages of and years and screened positive for active substance use. the current sample was actively participating in an ongoing antiretroviral therapy (art) adherence study at the time of the covid- outbreak. participants were taking part in an -month longitudinal hiv treatment engagement and adherence study. men and women living with hiv were recruited through social media websites, targeted online ads, and a participant-driven adaptation of snowball-sampling techniques. specifically, participants were encouraged to refer their hiv-positive friends to the study and were offered a modest incentive for their efforts. after informed consent, participants completed measures of demographic and health characteristics, including audio-computer-assisted self-interviews, blood samples for hiv viral load testing, and urine samples for substance use testing and urinary health markers. after the baseline assessment, participants were contacted monthly to complete health care engagement and health behavior interviews. all interviews were conducted by telephone as part of the original study protocol using methods consistent with best practices for conducting remote research. during a -month period, median months from baseline, partic-ipants due for their routine telephone interview completed questions regarding their experience with covid- . the university of connecticut institutional review board approved all study procedures. participants were asked their self-identified gender, race, age, years of education, the stability of their current housing, income, and employment status. we also administered the centers for epidemiological studies depression scale to assess symptoms of depression (alpha = . ) and the -item consumption subscale of the alcohol use disorders identification test (audit-c). , to assess food insecurity, we used items adapted from the us food security scale that have been validated in the past research and used by the us census bureau. we constructed an unweighted index of underlying health indicators for increased risk of covid- morbidity and mortality. the markers include hiv viremia, renal health markers, tobacco, alcohol, cannabis, and other drug use that were collected at the baseline assessment. to determine hiv rna concentrations (viral load), participants provided ml of fingerstick blood for dried blood spots collected in hemaspot hf devices that were frozen before laboratory delivery. hiv- viral load testing was conducted using the abbott realtime hiv- assay, a reverse transcription pcr assay performed on the automated abbott m platform (abbott molecular inc, des plaines, il). the target sequence for the assay is the highly conserved pol/integrase region of the hiv- genome. the limit of detection of the assay is . log copies/ml, and it can quantify up to . log copies/ml. all samples required an upfront processing to improve assay sensitivity before subjecting to rna extraction. forty-nine ( %) participants were unable or unwilling to provide a blood sample and were given the option to provide a recent viral load test result obtained within days of the assessment from a health care provider. because hiv viremia indicates greater immune suppression, a detectable viral load was coded as an indicator of covid- severity risk. urine specimens were collected and tested on site for health markers: glucose, an indicator of diabetes or renal disease; leukocytes, an indicator of urinary system inflammation , ; protein as indicative of kidney disease; and blood as an indicator of multiple disease processes. we used any positive urine health indicator as a marker for a potential underlying renal condition. because any substance use is a known immune suppressant, we conducted a multipanel urine dip test to detect common drug use. the test strip uses a lateral flow chromatographic immunoassay for the qualitative detection of drugs and drug metabolites (redwood toxicology labs-reditest- ). these tests are fda approved and are reliable and valid for initial screening of drug use in the previous - hours. we considered thc as a separate marker because it is prevalent and its administration is typically smoked, posing specific risks for compromised lung function. for alcohol use, we used the ng/ml cutoff for ethyl glucuronide from a separate dip test with detection of ethyl glucuronide up to hours after drinking. finally, participants reported smoked tobacco products with items adapted from the alcohol, smoking and substance involvement screening test (assist). telephone interviews assessed current hiv care engagement, treatment status, and art adherence. measures of health care engagement were adapted from the hiv cost and services utilization study consortium and include attending and not attending scheduled care appointments. to assess art adherence, we used the -item self-report instrument for retrospective adherence (ira) developed and validated by wilson et al. the items represent the number of days medications were taken over the previous days, the frequency of taking medications as directed, and a selfperception rating of how well medications were taken over the previous week. we used methods suggested by wilson et al to convert scores for each item on a scale of - using linear transformations and calculating the mean to a single adherence score with a range from to , interpreted as percent adherence over the past week (alpha = . ). wilson et al found that the ira correlates . with electronically monitored art adherence. the ira was administered during the phone assessment, as well as the phone assessment conducted the previous month. participants reported whether they heard of the novel coronavirus/covid- , how much they had heard about it, whether they had been tested for covid- , and whether they had been diagnosed with covid- . we also asked participants whether they had engaged in recommended actions to mitigate their risk for contracting covid- . all behaviors assessed were recommended by the us federal government and the state of ga to mitigate the spread of sars-cov- at the time the study commenced. the specific actions are shown in the results. we created an index of covid- protective actions by summing the use/nonuse of the behaviors. we also assessed participant concerns that they may contract covid- using a -point rating scale in response to the question: "from to , how concerned are you about catching the new coronavirus, with = not at all concerned and = extremely concerned." we asked participants whether they had been unable to get the food they need, get to the pharmacy, and get their medicines in relation to their response to covid- . participants were also asked whether hiv care providers and other service providers had canceled any of their care appointments because of covid- . we conducted descriptive analyses for participants identifying as male and female on demographic, health, and covid- protective behaviors using contingency table x tests for categorical variables and independent t tests for continuous measures. we also formed groups based on relatively fewer (# , n = ) and relatively greater ($ , n = ) covid- protective behaviors and examined differences between groups using contingency table x tests for categorical variables and independent t tests for continuous measures. poisson regression was used to test a multivariable model predicting the number of covid- protective behaviors from participant characteristics and the history of covid- severity risks. art adherence for the assessment period and the previous month was compared using a dependent (paired) t test. all statistical tests defined significance by p , . . table shows the participant demographic and health characteristics. most participants demonstrated a history of underlying health risks for severe covid- . as shown in table , half of participants did not know their cd cell count, an indicator of not being fully engaged in hiv care. among those participants who did know their most recent cd cell count, more than in indicated cd cell counts under cells/mm . in addition, in participants were not hiv suppressed and in tested positive for at least underlying renal condition. most participants were actively using substances, including % tobacco, % alcohol, % cannabis (thc), and % testing positive for other drugs. overall, % of our participants had at least indicator of immune suppression beyond their hiv status. nearly all participants reported staying indoors and away from public places to avoid contracting covid- . table shows the frequency of covid- protective behaviors in the early days of the pandemic. most participants had canceled plans, asked others to stay away, and avoided public transportation to mitigate their risk for contracting covid- . on average, participants had taken multiple steps to reduce their risks. however, there were gender differences in covid- protective actions, with women more likely to stay indoors and away from public places than men. consistent with this pattern, women also rated greater concern about contracting covid- than men. poisson regression indicated that participant gender, wald x = . , p , . , and level of concern for contracting covid- , wald x = . , p , . , predicted the number of covid- protective behaviors practiced; women engaged in more protective behaviors than men (b = . , se = . , % confidence interval: . to . ), and greater concern was related to engaging in more protective behaviors (b = . , se = . , % confidence interval: . to . ). the remaining factors in the model were not significantly associated with covid- protective behaviors: years of education, wald x = . , ns, years since testing hiv positive, wald x = . , ns, and number of risks for covid- severity, wald x = . , ns ( table ) . results showed that % of participants reported being unable to access food because of the covid- outbreak. participants who engaged in greater protective behaviors also experienced more difficulty accessing food compared with persons who engaged in less protective behaviors. among participants who reported being unable to access food due to covid- , % were not food insecure at baseline (table ) . nearly in participants (n = , %) indicated that they had missed a scheduled hiv care appointment in the previous days. when asked the reason for their missed appointment, ( %) spontaneously stated the reason was directly related to covid- . in addition to their missing a scheduled medical appointment, % of participants reported that a medical provider canceled an appointment, and % reported a nonmedical service provider contacted them to cancel an appointment due to covid- . participants who engaged in greater covid- protective behaviors also experienced more nonmedical service cancelations than participants engaging in fewer covid- protective behaviors (table ) . practicing greater covid- protective behaviors was also related to an inability to get to the pharmacy and an inability to access medications. there were no associations between covid- protective actions and art adherence in the month before, or the month during, the covid- assessment. however, adherence improved significantly in the month since the onset of covid- protective actions, t ( ) = . , p , . . covid- adds to what is already a complex matrix of co-occurring epidemics and health disparities facing people living with hiv. participants in the current study presented multiple challenges in managing their hiv infection before the emergence of covid- , including substance use, mental health problems, history of comorbidities, and food insecurity. most participants were polysubstance users, demonstrated clinical indications of depression, and experienced food insecurity as severe as hunger. we found that all participants were aware of covid- at the earliest days of response by their city officials. nearly all participants were taking some steps to mitigate their risk for covid- . their immediate response, however, exacerbated food insecurity, with more than in participants reporting difficulty accessing food, including individuals who were not previously food insecure reporting an inability to access food. covid- protective behaviors also impeded their health care, created barriers to accessing medications, and disrupted social services. similar impacts of covid- on hiv care have been reported by others , and have implications for widening what are already entrenched hiv-related health disparities. we also observed an unexpected significant increase in art adherence over the month of response to covid- . participants may have improved their art adherence out of health concerns or because they were home more, or possibly other reasons. , this positive change occurred despite interruption in accessing medications. it is possible that this increase in adherence is a blip and will subside, especially if barriers in accessing medications are not resolved. nevertheless, the heightened and uncontrollable health concerns brought by covid- may have motivated health behaviors for which individuals do have control, such as taking their medications. monitoring art adherence over the course of covid- should be a priority in ongoing studies. the current findings should be interpreted in light of their methodological limitations. the sample for this study was one of convenience and cannot be considered representative of people living with hiv. although large enough for the number of variables tested, the sample was relatively small. in addition, the sample was largely male and african american and therefore limited in its generalizability. in addition, we assessed substance use with biological testing and could not discern whether some drugs, particularly methamphetamine and cocaine, we smoked, with greater implications for complicating covid- . the study was undertaken in immediate response to the covid- public health crisis, and our findings may be transient and specific to people living with hiv may be at increased risk for a more severe clinical course of covid- , and our sample demonstrated a history of multiple factors that would likely contribute further to their risks for greater severity of covid- . of particular concern were high rates of hiv viremia, smoking, other substance use, and depression symptoms. we found that at baseline -in- participants had evidence of a potential underlying renal condition. of particular concern are % and % of participants testing positive for urinary glucose and protein, respectively, both of which are associated with covid- severity. the accumulation of risk factors for severe covid- among people living with hiv, who are already immune compromised, signals an urgent need to mitigate their exposure to sars-cov- . we found that women engaged in more protective behaviors than men and that protective behaviors were associated with how concerned participants were about contracting covid- . however, there was no association between the number of underlying risks for severe covid- and the number of protective actions taken. at the time of this study, public health messaging focused on increased covid- risks for the elderly and people with cardiovascular disease, diabetes, and immune suppression. although people with hiv will recognize their increased risks due to an immune suppressive condition, the added burden of smoking and other substance use, as well as underlying conditions common to hiv infection, have not been included in centers for disease control and prevention reports of severe case outcomes and have not been included in public health messaging. patients should be fully informed of their risks for severe covid- to understand the importance of long-term mitigation. maintaining hiv care during the covid- pandemic covid- in patients with hiv: clinical case series tuberculosis and hiv responses threatened by covid- epidemiological and clinical features of hospitalized patients with covid- in clinical manifestation, diagnosis, prevention and control of sars-cov- (covid- ) during the outbreak period the value of urine biochemical parameters in the prediction of the severity of coronavirus disease role of nutrition in hiv infection: review of evidence for more effective programming in resource-limited settings the impact of copd and smoking history on the severity of covid- : a systemic review and meta-analysis investigating the relationships between alcohol consumption, cannabis use, and circulating cytokines: a preliminary analysis cumulative exposure to stimulants and immune function outcomes among hiv-positive and hiv-negative men in the multicenter aids cohort study opposing effects of alcohol on the immune system double jeopardy: methamphetamine use and hiv as risk factors for covid- drug use is associated with anti-cd igg-mediated cd + t cell death and poor cd + t cell recovery in viralsuppressive hiv-infected individuals under antiretroviral therapy immune activation and neuroinflammation in alcohol use and hiv infection: evidence for shared mechanisms alcohol abuse and smoking alter inflammatory mediator production by pulmonary and systemic immune cells sars-cov- pandemic expanding in sub-saharan africa: considerations for covid- in people living with hiv symptoms, stress, and hiv-related care among older people living with hiv during the covid- pandemic three months in: a timeline of how covid- has unfolded in the us hiv care continuum and covid- outcomes among people living with hiv during the covid- pandemic hiv and food insecurity: a syndemic amid the covid- pandemic georgia department of public health covid- daily status report city of atlanta coronavirus disease (covid- ) response achieve research continuity during social distancing by rapidly implementing individual and group videoconferencing with participants: key considerations, best practices, and protocols development of the alcohol use disorders identification test (audit): who collaborative project on early detection of persons with harmful alcohol consumption ii an empirical investigation of the factor structure of the audit food security, poverty, and human development in the united states il: abbott laboratories hiv- viral load measurement in venous blood and fingerprick blood using abbott realtime hiv- dbs assay genital tract leukocytes and shedding of genital hiv type rna developing an adherence support intervention for patients on antiretroviral therapy in the context of the recent idu-driven hiv/aids epidemic in estonia a new test-strip for demonstrating erythrocytes and haemoglobin in urine (author's transl) collision of the covid- and addiction epidemics quantification of etg in hair, etg and ets in urine and peth species in capillary dried blood spots to assess the alcohol consumption in driver's licence regranting cases validation of the alcohol, smoking and substance involvement screening test (assist) prevalence and predictors of highly active antiretroviral therapy use in patients with hiv infection in the united states. hcsus consortium. hiv cost and services utilization cognitive and field testing of a new set of medication adherence self-report items for hiv care the burden of covid- in people living with hiv: a syndemic perspective from hiv to coronavirus: aids service organizations adaptative responses to covid- responding to pandemics: what we've learned from hiv/aids medication management and adherence during the covid- pandemic: perspectives and experiences from low-and middle-income countries telemedicine and support groups in order to improve the adherence to treatment and health related quality of life in patients affected by inflammatory skin conditions during covid- emergency editorial: covid- and anxiety and depression in severe outcomes among patients with coronavirus disease (covid- )-united states hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease -covid-net, states key: cord- - cclwzob authors: dindarloo, kavoos; aghamolaei, teamur; ghanbarnejad, amin; turki, habibollah; hoseinvandtabar, sommayeh; pasalari, hasan; ghaffari, hamid reza title: pattern of disinfectants use and their adverse effects on the consumers after covid- outbreak date: - - journal: j environ health sci eng doi: . /s - - -y sha: doc_id: cord_uid: cclwzob background and objective: the aim of this study was to investigate the pattern of disinfectants use within outbreak of covid- and estimate their adverse effects on the consumer’s health. methods: in this descriptive-analytical study, participants were entered into the study without age and gender limitations. a researcher-made electronic checklist containing questions was applied to collect data. the checklist included three sections: demographic characteristics ( questions), disinfection of body and non-living surfaces ( questions), and adverse effects of disinfectants on health ( questions). results: % of participants used the incorrect proportions of water and alcohol to make this disinfectant available at home. the percentage of people with wrong proportion of sodium hypochlorite was . %. approximately % of participants experienced at least one disorder on their hands, feet, eyes, respiratory or gastrointestinal systems after sequential uses of disinfectants. the most common disorders among the participants were found to be skin dryness ( . %), obsession ( . %), skin itching ( . %), coughing ( . %), and eyes irritation ( . %). the mean frequency of hand washing and hand disinfecting were . and . times per a day, respectively, and the clean-up in case of surfaces was . times a day. the frequency of hand washing and disinfecting in women group ( . and . times a day) were higher than in men ( . and . times a day) group. in addition, these self-care actions in married people ( . and . times a day) were higher compared to those in single people ( . and . times a day). conclusion: being unaware of participants with instruction for preparation and use disinfectants may harm their health. therefore, it is suggested that the authorities provide the necessary training program for public through official media. coronaviruses are viruses that can infect the respiratory tract, gastrointestinal tract, liver, and central nervous system of humans, cows, birds, bats, rodents, and other wildlife [ ] [ ] [ ] . coronaviruses, like influenza viruses, are being transmitted by various animal species in the wild. alpha-coronavirus and beta-coronavirus can infect mammals, and gamma-corona viruses and delta-coronaviruses tend to infect birds, however some types of coronaviruses can also be transmitted to mammals [ ] . the serious and applicable measurements were not considered until the outbreak of viruses of severe acute respiratory syndrome (sars-cov) in and in guangdong province, china. the middle east respiratory syndrome (mers-cov) coronavirus outbreak posed the greatest threat to the public [ , ] . however, in early december , the first cases of a syndrome with unknown origin were first identified in wuhan, hubei province, china [ , ] . the new and emerging coronavirus, which is considered as the seventh member of the coronavirus family [ , ] , has been responsible for this respiratory syndrome. currently, the prevalence of this acute respiratory syndrome, known as covid- , has been confirmed, worldwide. the total number of confirmed cases and deaths in the world as of june , was , , and , , respectively. in iran, the total number of cases and death at the same date was reported to be , and , respectively [ ] . in iran, the first death contributed to covid- was officially announced by the ministry of health and medical education on february , [ , ] . common symptoms of covid- include fever, cough, shortness of breath and respiratory problems. in more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death [ ] . the two main routes of covid- transmission are respiratory and contact routes. contact with infected person's respiratory droplets via coughing or sneezing, contact with a person with respiratory symptoms (sneezing, coughing, etc.), and contact with surfaces on which respiratory droplets are located are currently known as the primary pathways of coronavirus transmission [ ] . the literature show that the survival of human coronaviruses on surfaces varies from h to days [ ] . survival time depends on a variety of factors, including surface type, temperature, relative humidity, and pressure. the previous studies showed that effective inactivation (within min) using common disinfectants such as ethanol % and sodium hypochlorite is acceptable [ ] . health tips to prevent the spread of covid- include regular hand washing, covering the mouth and nose when coughing and sneezing, full cooking, avoiding close contact with a person who has symptoms of a respiratory illness such as cough and sneezing, and disinfecting surfaces [ ] . there are many disinfectants that are effective against covert viruses such as the covid- virus. the most commonly recommended disinfectants are ethanol % and chlorinated disinfectants such as sodium hypochlorite and calcium hypochlorite. after the outbreak of covid- and due to the lack of familiarity of consumers with disinfectants and their preparing methods, the lack of proper training in this field by trustees, and finally profiteering of some people and companies, some poisonings and health problems in disinfectants users have been reported. the aim of this study was to investigate the pattern of consumption for disinfectants by public after the outbreak of coronavirus and compare it with standard protocol. the additional aim of present research was to identify the adverse effects of disinfectants misuse. this cross-sectional study was performed within march and april . the research was approved by the ethics committee of hormozgan university of medical sciences (code: ir.hums.rec. . ). since there is no previous study in this field, cases were estimated to be studied based on cohen's table with % error and % power. the participants in the present study were the citizens of hormozgan province. hormozgan is a province in the south of iran. this province includes counties. the population of this province, according to the census in was estimated to be , , . until june , the number of people afflicted with covid- in this province was estimated to be and the mortalities were [ ] . no age or gender limitation were considered for participants. data were collected by completing questionnaires. due to the risk of transmitting the coronavirus through paper questionnaire, electronic self-made questionnaire were applied to collect data. the questionnaire consisted of three sections, including demographic characteristics ( questions), pattern of disinfectants use ( questions), and health effects of these substances on consumers ( questions). the total number of questions in the questionnaire was . questions were presented individually on the screen of mobile, tablet and computer and respondents were able to enter their answers by touching the corresponding buttons on the screen. respondents were not able to move on to the next question without completing the previous one, however they were able to go back and change their previous responses. the collected data were analyzed by spss . descriptive analysis were employed to describe the frequency, percentage, mean score and standard deviation of obtained data. t-test, one-way anova or their nonparametric equivalences were applied to analyze the data and the differences between groups. the results of the demographic characteristics of the participants in the study are shown in table . of participants entered into the present study, were male and were female. the mean age of the participants in the study was . years with a range of to years and the highest frequency was observed in the age group of to years. . % of the participants were married and . % were single. most of the participants ( . %) were employed by the government or the private sectors. in terms of education level, most of the participants ( . ) were found to have bachelor degree. . % of the participants lived in the rural and . % in the urban areas. the average frequency of hand washing between participants was found to be . times per day with minimum and maximum of and , respectively. the average handwashing frequency in women was higher than in the men group, and the difference between two groups was statistically significant according to the t-test statistics (p < . ). the main explanation for this result may be attributed to this assumption that women pay more attention to their personal hygiene than men [ ] . in addition, due to the fact that women in iran are responsible for doing household chores, including cooking and cleaning, and therefore this can increase their responsibility in relation to the health of other family members. the results obtained showed that married people washed their hands more compared to single people. however, the difference between two groups was not statistically significant based on the t-test statistics (p < . ). among married people, those who had children washed their hands more than those who did not have children. the t-test statistical test showed that the average hand washing frequency of two groups was significantly different. this result can be due to the responsibility of parents for the health of their and children. in addition, in the majority of iranian families, fathers are responsible for financing the living expenses. father's illness or death leads to temporary or permanent disruption of the family economy. in terms of the average frequency of hand washing, there was no significant difference between urban and rural areas (p > . ). the anova statistics showed that there was a significant difference between different jobs in terms of the frequency of hand washing (p < . ). however, this difference was not statistically significant between participants with different education level. the most effective cleaning agent for hand washing is liquid soap followed by, and solid soap is the next. . % of the participants claimed that they use other ingredients, such as washing powder and dishwashing liquid, to wash their hands. the contribution of different detergent applied for hand washing are shown in the fig. . due to the presence of skin incompatible substances in these detergents, skin damage is possible for the consumers of these detergents. % of participants do not use any detergent to wash their hands. as water alone is not able to eliminate microorganisms, especially coronavirus, these people are at higher risk for coronavirus. according to the world health organization (who), the proper time to wash hands is s [ ] [ ] [ ] . according to water supply officials in iran, the water consumption has increased by about - % since initial stage of the outbreak of covid- in iran. it is worth noting that part of this water consumption is contributed to washing and cleaning the house in special days of the new year, which coincides with the outbreak of covid- . approximately . % of participants sanitize their hands when the outbreak of covid- spread. in addition to the hands, disinfection of the feet, face and whole body was performed by . , . and % of the participants, respectively. the average frequency of hand sanitization by participants was . times with a minimum and a maximum of and , respectively. according to the t-test or anova statistics, there was no significant difference in the number of hand disinfections between different people categorized by age, gender, level of education, marital status, having children, place of residence and occupation (p > . ). the situations in which participants disinfect their hands are shown in the fig. . as can be seen from the figure, most participants disinfect their hands after coming back to home, nothing fig. the type of detergents applied for hand washing fig. the situations in which participants sanitize their hands after shopping, after going to the toilet, and after touching the hands of other. it is recommended that people disinfect their hands when doing certain activities, such as before and after eating, after going to the toilet, after shopping, and after touching contaminated or suspected surfaces of contamination. on the one hand, not disinfecting hands in the mentioned situations can increase the risk of spreading covid- , on the other hand, increases in the frequency of disinfections and overuse of these matters can cause adverse effects on consumer health. to overcome these problems, it is necessary to educate the people about the correct methods of hand disinfection. disinfection of the face, and feet was performed by . , . % of the participants, respectively. % of participants disinfect their entire body. apart from the hand, the recommendation to disinfect other parts of the body has not been reported so far [ , ] . over frequent disinfection of other organs, especially the face, can cause skin, eye, lung, and gastrointestinal disorders [ ] . participants ( . %) reported that they did not disinfect their hands after the coronavirus virus outbreak. of this group, . % wash their hands less than times a day. since washing hands with soapy water as well as disinfecting hands with alcoholic solutions is recommended as the most important ways to prevent covid- [ ] [ ] [ ] , the risk of getting covid- further threatens the health of these persons. % of participants disinfect surfaces. the average frequency of surface disinfection by participants was . times with a maximum of and a minimum of . the frequency of disinfections recommended for surfaces is [ , ] . in addition to health problems, frequent disinfection of surfaces can also damage the family economy. according to the t-test or anova statistics, there was no significant difference in the number of surface disinfections between different participants categorized by age, gender, level of education, marital status, having children, place of residence and occupation. the most important surfaces disinfected by participants were toilet ( . %), keys ( . %), credit card ( %), and mobile phone ( . %). the frequency of disinfection of other surfaces by the participants is shown in the fig. . the correlations between hand washing frequency, hand sanitizing frequency and surface disinfection frequency are shown in fig. . the correlation between hand washing and hand sanitizing frequency was . , while the correlation between hand washing and surface disinfection frequency, and between hand sanitizing and surface disinfection frequency were . and . and all of them were significant at level of . . the most commonly used substance by participants to disinfect their hands was found to be alcoholic solutions ( . %). . % of people use sodium hypochlorite bleach and . % use other substances. alcohol is not available for everyone due to its high cost and scarcity. some people, mostly lowincome people, use sodium hypochlorite bleach to disinfect their hands due to its low cost and availability. although lowconcentration of sodium hypochlorite bleach ( . %) can be used for hand disinfection [ ] [ ] [ ] , uses of sodium hypochlorite bleach with high concentration are limited unless in emergency conditions. repeated use of sodium hypochlorite bleach with inappropriate concentrations can cause damage fig. the surfaces disinfected by participants to the skin of the hands and respiratory problems for these people. some people have also resorted to the use of natural and herbal disinfectants such as vinegar. given that the effectiveness of these disinfectants has not been proven by scientific sources [ ] [ ] [ ] , their use causes a false sense of the safety, and the risk of afflicting these people to covid- is increased. sodium hypochlorite bleach is the most widely used disinfectant for surfaces disinfection by individuals ( . %). the next ranks belong to the alcohol solution ( . %). . % of participants use other materials than these for surface disinfection. lack of proper training to people to prepare and use sodium hypochlorite bleach can cause irreparable damage to their health. the best way to use sodium hypochlorite bleach for surface disinfection is to soak the fabric in sodium hypochlorite bleach and draw it on the surfaces. spraying sodium hypochlorite bleach on surfaces, in addition to spreading sodium hypochlorite bleach itself in the air, removes contaminants from the surfaces and suspend them in the air [ ] . correct time for disinfection is another point that, if not followed properly, the disinfection efficiency will be reduced. the appropriate time for disinfection by sodium hypochlorite bleach ( . %) is at least min [ ] . only . % of participants consider this contact time. . % of people claimed that they start drying surfaces immediately after using sodium hypochlorite bleach. due to the lack of contact time, the efficiency of the disinfection process will be reduced. . % of participants buy ready-to-use disinfectant solutions, and . % buy the raw materials and mix them at home with fig. correlation between hand washing frequency, hand disinfection frequency, and surface disinfection frequency according to spearmen rank correlation coefficient other substances such as water to make them ready for use. alcohol-based solutions and sodium hypochlorite bleach are the most widely used disinfectants by participants after the outbreak of coronavirus. . % of participants mix alcohol with substances other than water. the reaction of these substances with alcohol can lead to the production of harmful secondary compounds that are harmful to health. due to the facts that the appropriate concentration of ethanol for disinfection is to % [ ] [ ] [ ] [ ] and the alcohol available in the market mainly has a concentration higher than - %. the best way to prepare an alcohol solution to disinfect the hands and surfaces is mixing three cup of % alcohol with one cup of water [ , ] . this method has been followed only by % of participants. other patterns used by people neither have the necessary effectiveness for disinfection, nor have adverse health effects on consumers. % of participants do not follow the correct pattern of mixing alcohol with water. the correct pattern for mixing sodium hypochlorite bleach) % active chlorine(with water to prepare a concentration of . % chlorine suitable for disinfection of surfaces is one cup of sodium hypochlorite bleach with cup of water [ ] . about % of the participants used a different method other than the aforementioned pattern to prepare the sodium hypochlorite bleach solution. approximately . % of people have used the sodium hypochlorite bleach in a concentrated form without mixing it with water, which can have very adverse effects on their health. approximately . % of participants mix sodium hypochlorite bleach with other substances than water. secondary substances produced by the reaction of these substances may have an adverse effect on consumer health [ ] . the use of personal protective equipment (ppe) such as masks and gloves is one of the requirements when uses of surface disinfectants [ , ] . . % of people didn't use any personal protective equipment when using disinfectants for surfaces, which endangers their health. the ppe used by consumers were shown in fig. . in iran, the national radio and television are known as the most important and reputable source of news related to covid- , and the people have been advised to follow the news and recommendations for the preventive measurements against covid- through these media. selected references by participants to obtain instructions on the use of disinfectants are shown in fig. . as can be seen from this figure, the highest contribution belongs to social networks ( . %), followed by radio and television ( . %). although social media has played an undeniable role in informing about covid- , a large number of unscientific recommendations have been spread through social networks. the implementation of this recommendation by some people has caused irreparable damage to their health. advices to use methanol instead of ethanol for disinfecting hands and surfaces and drink alcohol to remove the virus from the body were those that have led to poisoning, blindness and even death in some people. . % of participants have used methanol (red or industrial alcohol) instead of ethanol (white or medical alcohol) for disinfection. due to the proven adverse effects of methanol such as blindness, skin damage and even death [ ] [ ] [ ] , its use for disinfecting body organs and surfaces is strictly prohibited. . % of the participants provide disinfectants from centers other than pharmacies and health centers. the huge profits from the sale of disinfectants after the outbreak of the coronavirus have led some profiteers to produce counterfeit disinfectants using hazardous chemicals; many of disinfectants produces have been seized by legal authorities [ , ] . therefore, it is recommended that people obtain disinfectants from reputable centers and stores and ensure the safety of these substances. . % of people keep disinfectants in inappropriate places such as kitchens, bedrooms, toilets and bathrooms. storage of disinfectants and disposal of empty containers is one of the points that must be done correctly in terms of safety. keeping disinfectants available to children and near food items can cause poisonous effects on family members. the best place to store these materials is in a warehouse, away from family members and flammable materials [ ] [ ] [ ] [ ] [ ] . in addition, the appropriate temperature and storage time for these materials must be considered according to the manufacturer's instructions. regarding the majority of chemicals, including disinfectants, it is recommended that their empty containers must be delivered separately from other waste to organizations that are responsible for managing such waste. . % of participants dispose empty containers, along with other waste, which can be detrimental to the health of waste collection personnel and cause possible fires at waste storage and disposal sites. adverse effect of disinfectants . % of participants had health problems in at least one organ of their body due to the use of disinfectants. the results of the adverse effects of disinfectants observed between the participants re shown in fig. . the most important skin effects on the hands and feet, were found to be itching, redness, dryness, and sores. eye effects included eye irritation and itching, tearing, and decreased vision. lung irritation, shortness of breath, cough and sneezing are some of the frequent effects observed in the respiratory system. abdominal pain, diarrhea and vomiting have been common gastrointestinal symptoms. throat irritation, obsessive-compulsive disorder, lack of concentration, headaches and dizziness and fatigue have been other adverse effects of disinfectants on people. in addition, . % of participants claimed that they or their relatives had eaten disinfectants, including alcohol, to treat coronavirus and had to see a doctor because of its side effects. in this study, the pattern of preparation and consumption of disinfectants after corona outbreak and adverse effects of these substances on consumer health were examined. the results indicated that a significant number of participants are unfamiliar with the principles of preparation and use of disinfectants. improper preparation, uses of disinfectants in unconventional concentrations, storage in unsafe places, excessive use of these materials, receiving instructions for the use of these materials from unreliable sources and improper disposal of empty containers are the most important mistakes made by participants. because the misuse of these substances can have irreversible effects on people's health, it is necessary for health authorities to provide the necessary training for consumers from official and reputable authorities. fig. the impacts of 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guidance investigation into a cluster of infant deaths following immunization: evidence for methanol intoxication ethylene glycol or methanol intoxication: which antidote should be used, fomepizole or ethanol impulsive differential equation model in methanol poisoning detoxification climate impact on corona virus in the world a critical analysis to comprehend panic buying behaviour of mumbaikar's in covid- era acute hazards to young children from residential pesticide exposures women's strategies for handling household detergents hazardous waste, impact on health and environment for development of better waste management strategies in future in india household hazardous materials and their labels: a reference for teachers store hazardous products safely: your home may be an accident waiting to happen publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations acknowledgments we are sincerely thankful to social determinants in health promotion research center, hormozgan health institute, hormozgan university of medical sciences for funding this research. conflict of interests the authors declare that there is no conflict of interests. key: cord- -j d nb authors: hudson, janella; ungar, rachel; albright, laurie; tkatch, rifky; schaeffer, james; wicker, ellen r. title: older adult caregivers’ experiences in an online, interactive mindfulness intervention date: - - journal: j evid based integr med doi: . / x sha: doc_id: cord_uid: j d nb background. while today’s older adults experience longevity, they often manage several chronic conditions and increasingly serve as informal caregivers for aging parents, children with life-long disabilities, and spouses. older adult caregivers managing personal chronic illness often experience significant psychosocial hardships. objective. the primary purpose of this study was to explore the experiences of older adult caregivers in an online, interactive mindfulness intervention. methods. self-reported older caregivers who participated in an online-based mindfulness program (n = ) were recruited for semi-structured interviews. participants were asked to provide feedback about any previous experience with mindfulness and/or meditation, hopes or goals held prior to the start of the program, desired expectations, motivation for joining, impressions of sessions, most beneficial topics, potential application of content, and any perceived effects. participants’ responses were analyzed using qualitative content analysis. results. five themes emerged from the analysis: managing the comprehensive effects of caregiving, openness to meditation and mindfulness, course engagement and incremental growth, building rapport through shared experiences, and ongoing application and opportunities for refinement. participants reported both short-term post-exercise benefits such as increased calm, relaxation, and stress relief, as well as long-term positive outcomes. notably, participants found the program’s unique interactive feature to be particularly beneficial as a form of perceived social support. conclusions. caregivers for older adults may derive benefit and potentially experience reduced subjective caregiver burden as a result of participating in a mindfulness-based stress reduction (mbsr) program, particularly when the program is augmented with a self-compassion approach and perceived social support. shifting demographics in the united states have yielded an increasing population of older adults. in , the population of individuals aged or older was . %, projected to increase to . % by . , while today's older adults experience longevity, they often manage several chronic conditions and increasingly serve as informal caregivers for aging parents, children with life-long disabilities, and spouses. , a report published by the aarp public policy institute and the national alliance for caregiving in found that . million americans provided unpaid care to an older adult in the previous year. many older adults, particularly those with personal chronic illness, experience significant hardships while attempting to provide care for others. caregiver burden refers to the physical, financial, and psychosocial hardships of caring for a loved one struggling with a medical condition. objective burden results from providing physical forms of assistance, while subjective burden is related to the psychological, social, and emotional impacts of objective burden. caregiver burden affects emotional, social, financial, and physical domains and is estimated to affect up to % of caregivers. adverse health outcomes associated with caregiver burden include social isolation and anxiety, , higher rates of depression, , mortality, poorer quality of life, and cardiovascular disease, with possibility of increased burden experienced over time. a study of caregivers found % were vulnerable older adults experiencing difficulty with providing care and poor personal health. further, caregiver burden also adversely affects recipients of care, with reported outcomes including more frequent hospitalizations and higher levels of mortality. , caregivers often describe psychosocial contexts that include complicated emotional reactions to their caregiving responsibilities, such as struggles with stress, anxiety, exhaustion, loneliness and pain. , therefore, efforts to ameliorate caregiver burden potentially provide benefit for both caregivers and recipients. mindfulness refers to one's focused attention on the present moment and nonjudgmental awareness. bishop et al. proposed a -component model of mindfulness, with the first component consisting of the self-regulation of attention, allowing for increased recognition of mental events in the present moment. the second component involves adopting a particular orientation toward one's experiences in the present moment, an orientation that is characterized by curiosity, openness and acceptance. mindfulness meditation as a practice refers to focusing one's attention on the emergence of thoughts, emotions and body sensations while observing them as they arrive and pass. trait mindfulness and mindfulness interventions demonstrate changes in underlying biological mechanisms that contribute to mindfulness benefits, such as reducing the connection between the amygdala and other regions of the brain that drive stress reactivity, decreasing respiratory rates and potentially normalizing diurnal cortisol secretion among those with high cortisol levels. , further, mindfulness interventions have been found to counteract the sympathetic fight or flight response by increasing parasympathetic nervous system activation. , these biological changes potentially contribute to positive outcomes in other aspects of health and wellness. mindfulness meditation positively influences several aspects of physical health, including increased immune functioning, [ ] [ ] [ ] [ ] increased telomere activity, reduced blood pressure and cortisol levels. psychological benefits include reduced stress, anxiety, depression, medical symptoms and psychological distress. [ ] [ ] [ ] [ ] [ ] [ ] [ ] further, the practice of mindfulness promotes well-being, improves focus, reduces loneliness and related inflammatory responses to loneliness; [ ] [ ] [ ] is inversely related to neuroticism and rumination, and positively related to body satisfaction. , research has shown that individuals with a higher degree of mindfulness are more empathetic toward others and themselves, compassionate, accepting and have stronger interpersonal skills. , therefore, the benefits of mindfulness-based interventions are particularly promising for older adult caregivers experiencing psychosocial issues related to their caregiving responsibilities. mindfulness-based stress reduction (mbsr) interventions have helped caregivers manage stress across a variety of care contexts, including recipients with chronic illness, developmental disabilities, and dementia, and have demonstrated reduction in caregiver burden. , historically, in-person attendance at mindfulness sessions has represented a key limitation for caregivers. however, recent interventions acknowledge the increased rates of technology usage among older adults by offering online adaptations of mbsr program offerings. research has established the feasibility of an online mbsr program for older adult caregivers but greater insight is needed to understand these participants' experiences with engaging this material in an online format. thus, the primary purpose of this study was to determine the effects of participation in an online, interactive mbsr intervention for older adult caregivers. this study was part of a collaboration between (blinded) and (blinded). the overall goal of this collaboration was to explore the potential benefit of an online mindfulness intervention in improving mental and emotional health for older adult caregivers. this study was approved by the new england institutional review board (neirb # ), an independent institution that reviews for protocols for nonacademic institutions. the -week course was based upon mbsr and mindful self-compassion approaches. session topics over the course of the weeks included the following: ) mindfulness and healthy aging, ) anchoring with the breath, ) resiliency, social connectedness and wellbeing, ) mindful body awareness, )working with thoughts, challenging emotions, ) challenging body sensations, and ) compassion, kindness, and action planning. participants were given the option of attending of weekly sessions led by a trained facilitator via webex. during the webex session, participants were able to engage in -way communication with the facilitator and other attendees using a chat function, and when the facilitator allowed individual feedback. all sessions were minutes except for the first session, which was scheduled for minutes to accommodate orientation-related tasks, including introductions, an overview of the program, and initial troubleshooting of any technology-related issues. during the course of each weekly session, the facilitator led a brief discussion of the previous week's topic, presented didactics related to the chosen topic, and facilitated a guided meditation. the facilitator initiated open-ended questions related to module content and caregiving experiences, and also allowed time for participants to further discuss topics or questions related to the course topic or caregiving resources after the official close of the session. participants unable to attend a live session at the designated time were invited to attend previously recorded "drop-in sessions," which included review of didactics presented via powerpoint presentation and a prerecorded guided meditation. pre-recorded sessions presented didactics and the meditation exercise using a powerpoint format, which did not allow users to interact with the facilitator or other attendees in real time. additional program resources included a resource library with videos, additional tips, supplemental readings, and meditation exercises indexed according to topic. this study was the second phase of a larger multi-phase research study intended to better understand the health-related issues of older adults covered by aarp ® medicare supplement plans from unitedhealthcare (for new york residents, unitedhealthcare insurance company of new york). in this phase, a qualitative research study was conducted using standard qualitative procedures for conducting and analyzing semistructured interviews. the purpose of these interviews was to elicit participants' experiences while participating in a mindfulness program. participants who previously participated in the first phase of the study were recruited to participate in semi-structured interviews. the interview guide consisted of questions. questions elicited feedback for a number of topics. the interview guide included questions that asked participants to describe the degree to which they were familiar with the concepts of mindfulness and meditation prior to learning about the program, any previous experience practicing mindfulness and/or meditation, whether any friends or family members practiced mindfulness and/or meditation, any hopes or goals held prior to the start of sessions, and any desired expectations as result of their participation in the program. participants were asked to share their role as a caregiver, any support or help received in that capacity, current sources of emotional support, existing opportunities to connect with other caregivers, and existing coping mechanisms. questions also asked participants to describe their initial impressions of the sessions, motivation for joining, comfort level with managing technology, potential areas of focus, details regarding the customary setting of their meditation practice, completion of "homework" assignments, and attendance at optional "drop-in" sessions. additionally, interview guide questions asked participants to describe favorite, most helpful and least helpful topics, potential application of new learnings, and any observed effects in their lives (in general or caregiving specifically). in addition, they were asked to describe any changes to perspective or mental, emotional, or physical health. several questions prompted participants to describe the degree to which they interacted with the instructor or other caregivers in the group, the nature and topic of those interactions, whether they requested advice or resources from others, and any potential benefit derived from those interactions. a few questions elicited participants' satisfaction with program administration, including reminder calls, clarity of instruction, and perceived accessibility of available support. lastly, participants were invited to provide feedback of any nature. eligible participants from the first phase of the study were stratified according to age range and gender, with the aim of recruiting an equal proportion of participants from each segment. given recommendations that indicate - participants as an adequate sample size for an interview study, investigators planned an initial goal of interviews, after which they decided to assess whether data saturation had been achieved and recruit additional participants if necessary. data saturation refers to the point at which no additional characteristics within categories emerge as significant in the process of analysis. a marketing research company was provided with a list of the eligible participants who completed t and t surveys (out of who originally enrolled and only completed a t ). the marketing company was instructed to recruit participants with as even a distribution as possible among age range and gender, given the available sample. recruiters contacted participants by telephone, verified identity, explained the study, and scheduled interviews with the first participants successfully recruited according to the guidelines for stratification. verbal consent was obtained prior to the start of the interview. interviews lasted approximately hour. no personal identifiers were collected. all interviews were audio recorded and transcribed verbatim. the primary purpose of the intervention was to determine if participation in an online meditation intervention would improve the mental and emotional health of older adult caregivers. the first phase of the study consisted of a program evaluation in which a sample pool of aarp medicare supplement certificate holders, previously identified as caregivers, were recruited for participation in the study. inclusion criteria for the study consisted of those who were previously identified as a caregiver using a screener administered via an interactive voice (ivr) survey in conjunction with aarp's aging strong initiative. exclusion criteria included not being a current enrollee in an aarp medicare supplement plan, currently engaged in care coordination services, not currently enrolled in an aarp medicare supplement plan, younger than years of age, on the "do not call" list, not having a valid phone number, not web-enabled, and not a caregiver. all other participants were considered eligible for participation. potential participants received pre-mailer scripts prior to an invitation to participate via telephone. participants were directed to the provider's website to review terms, conditions, privacy policies, and to provide consent if all terms were amenable. three surveys were administered: prior to the start of the program, after the conclusion of the -week program, and - days later to assess the effects of program participation. in addition, participants who registered to participate in the program but missed the first program session received an ivr phone call. participants also received reminder emails encouraging completion of the surveys. investigators analyzed participants' transcribed interviews using qualitative description. qualitative description was an ideal methodology for this data as it draws from a naturalistic perspective, offers flexibility in commitment to a theory or framework, typically involves review of interview data, and allows for maximum variation sampling. two investigators (j.h. and r.u.) conducted a qualitative content analysis using an iterative, constant comparison process. during the coding process, both coders independently read transcripts, identified an initial code list, and developed operational definitions. then coders returned to the transcripts and conducted line-by-line coding that included comparison and refinement of identified coding between both investigators. coders subsequently discussed, reviewed, and reread interview data to develop final coding and to reach consensus about meaning. one investigator coded all transcripts while the other coded % of the overlap. both investigators reviewed coding on overlapping transcripts to reevaluate passages coded across researchers, and the codes applied based on the assigned definition in the codebook. any conflicts in assigned codes was settled through discussion until consensus was reached. next, both investigators examined the properties and categories of all codes to identify opportunities for categorization according to shared properties. investigators subsequently used this categorization of codes to develop overarching themes that described patterns of usage and provided a narrative of participants' overall use. throughout this process, investigators were mindful of the biases and existing perspectives they brought to the analysis. final coding was imported into nvivo, a qualitative software program. twenty individuals participated in the study, with an even distribution of males (n ¼ ) and females (n ¼ ). breakdown in age range was as follows: - (n ¼ ), - (n ¼ ), - (n ¼ ). the average participant age was . dosage data showed the mean number of sessions attended by participants was . with a median of sessions. participation among those in this study was higher than that of the overall population of caregivers at a mean of . sessions attended and a median of sessions. investigators ultimately developed themes that reflected participants' experiences, feedback, and reported outcomes: managing the comprehensive effects of caregiving, openness to mindfulness and meditation, course engagement and incremental growth, building rapport through shared experiences, and ongoing application and opportunities for refinement. participants' descriptions of their caregiving roles varied. some described providing in-home support to aging parents, closely monitoring the care of parents residing in care centers, assuming increased responsibility for the care of a spouse who resided with them, or providing care or supervision of siblings. in addition to providing care, participants also described acquiring new duties on recipients' behalf, such as assuming responsibility for finances and medical decision-making. while several participants were able to name supportive friends or family members, many with significant caregiving responsibilities, such as providing in-home care, expressed a desire for a greater degree of social support and often felt others might not want to hear about their difficulties. participants reported utilizing a number of coping mechanisms, including exercise, spending time with friends, gardening, home improvement programs, and journaling. i don't have anyone i can just vent to, but i keep a journal. somebody told me a long time ago, if you get crazy, sit down and write a letter and then don't mail it-burn it. it's just letting off the steam that's good. but i do think it's my fault if i don't have somebody i can talk to. i think guys have a harder time findings friends like that than women do. ( ) those with significant caregiving responsibilities were more likely to report difficulty in maintaining social connections, practicing self-care, and identifying consistent, regularly accessible coping mechanisms as a result of their caregiving responsibilities. as one caregiver explained, well, i was exercising, but [recipient]'s been in such bad shape, i haven't been able to get back to the gym and everything, and i enjoyed that. for a while i had a friend, and we rode our horses together for an hour every day or once a week or something, and that helped me. but now i'm afraid to leave [recipient] . i'm afraid he'll fall and nobody will be there. ( ) in this way, participants' self-assessments of their caregiver burden often signaled the need for greater self-care and social support. almost all participants reported familiarity with the terms "mindfulness" and "meditation" and were able to distinguish between them. slightly over half (n ¼ ) reported some degree of previous experience with mindfulness/meditation, including previous unsuccessful attempts at self-learning. three participants described current mindfulness/meditation practices, and others disclosed they had experience with other iterations of meditation, such as transcendental meditation, in previous years. others were curious to learn more and recognized "mindfulness" as a "buzz word" that had gained increasing popularity in mainstream media. as one participant noted, everybody seems to be selling mindfulness one way or the other these days. some participants related previous self-guided attempts at mindfulness or meditation that did not result in sustained effort due to uncertainty or need for further instruction. many shared they already planned to seek additional information about mindfulness prior to learning about the program. it was top of mind because my wife actually has parkinson's disease. the doctor had been encouraging us to learn more about it. we heard more from friends and relatives who'd also done meditation or mindfulness, and so it seemed like something we should explore. ( ) i was excited, i thought it would be very helpful. i was familiar with mindfulness from my own experience, i have read a few books. i'm a librarian at the cancer center, so there's a book about mindfulness dealing with cancer. ( ) upon learning of the opportunity to participate in the program, those with an existing practice of mindfulness and/or meditation expressed a desire to go "deeper" in their practice, curiosity about the feasibility of an online format, and interest in learning how these principles could apply to their role as a caregiver. participants with less familiarity about mindfulness/ meditation expressed an interest in learning more about these concepts, as well as determining whether these approaches could provide benefit to them as caregivers. most participants were pleased to learn classes were offered online, increasing the likelihood they could attend. for many participants, the program represented an opportunity to address caregiving-related challenges, including chronic stress, anxiety, depression, time constraints, and strained relationships. my time was so fragmented between caring for my wife's needs and my mother's needs, and there was very little time left for me. i'd heard this expression before, that the caregiver oftentimes will die before the person receiving the care, and i thought, "you know, i'm finding myself in that position. i'm not happy with what's going on and i need to change it. ( ) i just wanted the patience to accept that we're both aging and we can't hear and see as well as we used to. sometimes it's hard to, you know, be patient. ( ) accordingly, almost all participants' pre-attendance goals centered on increasing their knowledge about mindfulness, advancing existing mindfulness practice, and reducing stress and distress related to caregiving. participants also set goals related to reclaiming personal time to address their own needs, improving sleep quality, demonstrating more patience when delivering care, and managing emotions such as anger and impatience. to help me not become frustrated and hopeless when certain situations arise, and help me to relax and be able to better work my way through. ( ) when asked to describe their comfort level with managing the technology required for an online-based program, many participants reported they previously used webex for work purposes and were familiar with its functioning. a few participants expressed concerns about unreliable internet service in rural areas, aging software or hardware, or less experience accessing the internet. most participants reported they completed their sessions in a quiet area of their home, often in one's bedroom, office, or living room while in front of a computer. participants prioritized locations they deemed the most comfortable, quiet, and private, with the ability to change the brightness of the room if needed. several participants desired room to lay down during exercises, while others explained they remained seated in a chair even if the session's facilitator suggested lying down at the start of the lesson. several participants reported experiencing difficulty with managing the program's technology, including older, incompatible versions of software, and browser issues. however, affected participants reported most issues were addressed and resolved prior to the start of the second sessions. a few participants experienced a lag or buffering as a result of their internet service, and several participants preferred accessing the session via phone. the majority of participants appreciated the format of the classes, with equal time allocated for didactics and meditation practice, and judged an hour was the perfect amount of time for the class. favorite topics/concepts included self-compassion, self-care, resiliency, pause/breathe/observe/respond (pbor), physical self-care through proper nutrition and sleep, as well as managing physical pain and discomfort. one of the topics, about caring for yourself while being a caregiver, i thought that was really relevant. like how a person manages to take care of themselves while they're giving all this attention to other people and energy to other people. how are you going to sustain that if you don't do some stuff for yourself emotionally and every other way? i think it's just vital. ( ) the lesson on gratitude mindfulness. the pbors. that was the pause, breathe, observe, respond. it's a lot easier for people to receive a response rather than a reaction. and it puts mindfulness and determination into whatever there is. i can be quick with the tongue, and that can be hurtful to the people around me. so pbor was a good move. ( ) gratitude, being grateful for where you are and what you are. it's easy to get wrapped up in other people's concerns, other people's problems. especially if you're a caregiver and feeling for yourself, regretting what you're doing. you're always thinking you could be better off somewhere else or in some other situation. ( ) individual focus and objectives during meditation exercises varied among participants. while some participants reported close monitoring of the facilitator's voice and instructions, others gave particular focus or effort to various meditationbased components, such as the flow of the breath, relaxation of body parts, clearing the mind, regulating one's flow of thoughts, and setting intentions. participants frequently reported their comfort with meditation increased with continued practice, and that focused concentration on the flow of breathing helped to corral wandering thoughts. usually i focused on my body, how i felt internally. focusing on noticing my thoughts, noticing the sensations physically, just trying to slow things down. sensory awareness of sounds and smells and pressures on my body as i was sitting in a chair. ( ) i was trying to focus on my breathing a lot, and i do think that's beneficial, at least for me. it kind of clears my mind a little bit because i am concentrating on my breathing, and so i kind of let some of the other thoughts go. so from that standpoint the mindfulness was probably good for me because i could just divorce myself from the other things that were going on, were going to be happening for the rest of the day. i forced myself to just be thinking about breathing. ( ) several participants reported occasionally completing the "homework sessions" in which users were given the opportunity to revisit content topics and further practice with prerecorded meditation. however, many others reported insufficient time due to competing priorities, caregiving responsibilities, and a preference for attending the live sessions with other attendees. participants described several immediate post-exercise benefits, including improved calm, a relaxed state and improved energy. some practiced meditation at their bedtime and observed they were able to fall asleep more easily at the end of the exercise. if i couldn't fall asleep right away, then i would remember that maybe i should think of things that i was grateful for. if was worried about something, after i thought about what i was grateful for, it would redirect my mind to something more positive. ( ) participants also explained that completion of meditation exercises prompted an attitudinal shift that better prepared them to face the rigors of the day and helped them reflect on the day's events with more gratitude. several participants also found themselves applying mindfulness and meditation principles during potentially stressful moments. many described making deliberate efforts to take care of themselves by finding interrupted quiet time, taking a break, or otherwise finding opportunities to rest and recover from their caregiving responsibilities. others described improved social encounters in which they applied the learned frameworks of compassion and nonjudgement. i was ready to take on the day. i was ready to take on whatever challenge presented itself. and i felt like i had taken care of myself. i had done an hour of self-care, so i was ready to go back to taking care of everybody around here. ( ) it improved my compassion. i wasn't so quick to judge or quick to want to move things along. i was more in tune with the idea that things are going to happen at their pace; and if you recognize and work with it, then your life is a lot simpler and a lot easier. ( ) building rapport through shared experiences while participants perceived many components of the program's meditation and mindfulness curriculum to be beneficial, they were especially appreciative of the interactive nature of sessions. more specifically, participants cited the ability to submit comments and questions directly to the instructor for response via a chat function, as well as the ability to confer with other attendees, among their favorite features of the program. while several participants appreciated the flexibility offered by drop-in sessions, most caregivers expressed a strong preference for live meditation sessions hosted by the facilitator, as compared to optional pre-recorded drop-in sessions that were offered throughout the week. pre-recorded sessions presented didactics and the meditation exercise using a powerpoint format, which did not allow users to interact with the facilitator or other attendees in real time. participants explained the live interactive exchange provided a more fulfilling experience, allowing feedback from themselves and fellow attendees, as well as the opportunity to learn more about others' personal contexts of caregiving. further, participants described live sessions as being more "real," even if the content of both the live and prerecorded sessions was similar. having a live person there instead of just finding a time to listen to a recording really made a difference as to whether i was going to do it or not. i guess it would be similar to if i was sitting across the table from you and talking, or talking to you on the telephone. there just seemed to be a better connection. don't ask me why. that's just how it is. ( ) what made it valuable was the fact that it was a live course. i think the social element where you know other people are doing the same thing probably made a difference. it was interesting to have people with their own problems and personalities chime in. kind of livened it up, so i think it was important, a big part of the program. ( ) the live sessions, i really enjoyed them. i don't know if i could do eight weeks of prerecorded sessions. ( ) similarly, participants described deriving comfort and support from other caregivers. participants enjoyed hearing others' accounts of caregiving, and often used time at the end of class to consult other attendees about resources or approaches. hearing others' caregiving experiences helped many caregivers to feel less alone, fostered a sense of connection to a larger community, and also provided perspective about their personal circumstances, as compared to others' situations. caregivers with fewer responsibilities or lesser subjective burden expressed empathy for attendees whose accounts revealed ongoing struggles and loneliness, and expressed new gratitude for their own circumstances. those more heavily burdened found comfort and solace when identifying shared struggles in others' accounts. it's a support group atmosphere. they're also caregivers. you can related to them, you appreciate the random comments. i think it makes me a better caregiver because you know you're not the only one having these problems. even if they don't have the solutions, it just feels good. ( ) i learned i'm not alone in the struggle, and that it's hard work. some people, i'm not sure how they survive with what they have to do to care for their loved one. most of us didn't decide to be a nurse. people would share something they did that particular week or that day or an idea which would make me think, "oh, hey. i can do that". ( ) ongoing application of mindfulness and meditation, and opportunities for refinement participants reported many long-term, post-program gains as a result of their participation in the program. reported benefits varied and ranged from descriptions of changed perspectives, altered relationship dynamics, greater confidence, implementation of new schedules and/or habits, and integration of meditation and mindfulness practices in daily life. many reported that their perspectives about existing relationships and appreciation for others was improved by greater empathy and compassion. i have family members that live down here and i didn't appreciate what they do. even though i disagree with some of the things, i could look at it from a different perspective. i thought, "ok, i need to have that compassion and understanding". ( ) others reported that, while their circumstances may not have changed, they gained new tools and coping mechanisms that significantly lessened their stress and anxiety. it's not like i don't get worried or scared and stressed, especially about my husband. about what's going to happen to him and then what's going to happen to us as result of this. it's not that i don't. but i'm working at accepting the situation and trying to abide with it rather than trying to push it away and say, "oh, this isn't right. this is ruining my life". ( ) you figure out what the discomfort is and realize that very few things are as bad as we think they are. get to the core of the issue, it's usually manageable one way or the other. that was what i got out of it, that you discover the source of your discomfort. if you can be a little rational about this stuff, it's a lot easier to deal with. ( ) participants also described adopting a new mindfulness approach to daily tasks with renewed focus. many participants also described gaining a new understanding of the importance of self-care: i think it was allowing me to consider my own life to be the most important of any consideration rather than putting my own needs and wants last on my plate. i put them first now, and then my mother and wife come second and third. so i kind of reordered my priorities, if you will. ( ) one of the big things i took away was that you have to focus on yourself, you've got to understand that you've got to take care of yourself too, and that was a huge thing i took away from that. ( ) almost all participants planned to continue to practice mindfulness and meditation going forward, and for the long term. several participants shared they planned to use the year-long access to library resources offered to all attendees. the majority indicated they were highly likely to recommend the program to others, and not just to caregivers. many participants pointed out that, while the program was helpful for developing coping skills and a renewed perspective, it could be improved by supplemental services such as therapy. other suggestions included recommendations to address related topics during class exercises, such as depression and mental health, dealing with life's challenges and grief, managing chronic illness, and utilizing mindfulness and/or meditation to achieve happiness and maintain brain health. a counselor that would enable them to diffuse their angst and unwind a bit, and find a way to enjoy all the colors of life besides this one thing, because i think these people demonstrated to me that they could become so overwhelmed by all that they didn't see anything else but a dark future. ( ) participants also recommended additional social support, both in the form of strengthening the program's existing features, and adding new avenues of interaction. many participants valued moments when the facilitator prompted them to share aspects of their caregiving experiences, as well as opportunities when attendees connected at the end of the exercise. several individuals desired an expansion of those moments, as explained by the following participant: i realize this was not group therapy. but some people provided thoughtful responses. i remember one woman said that instead of getting enraged at her husband, that she was able to soften her voice and not be angry. and so what [the facilitator] might have done with that is say something like, "has anyone else had that experience of being able to modify their response to their partner?" so it'd get other people to say, "well, yeah, i did." and then he could say, "well, what's that like for you people that had that experience, or 'can you imagine what that might be like if you do.' it would just help expand it a bit". ( ) others requested opportunities to communicate more directly with other attendees, preferably in smaller groups to facilitate rapport building and allow additional time for sharing about caregiving struggles. additional suggestions included providing recommended readings of helpful caregiving sources, offering regionspecific referrals for caregiving resources, integrating yoga with mindfulness, and providing transitional "phase " classes to further develop newly acquired skills. the purpose of this study was to explore the experiences of older adult caregivers in an interactive, online mbsr-based intervention. participants described both short-term postexercise benefits, as well as long-term outcomes. notably, participants found the program's unique interactive feature, which provided accessibility for users' collaboration with facilitator guidance, to be of particular benefit and a form of perceived social support. feedback indicates older adult caregivers derived benefit and potentially reduced subjective caregiver burden as a result of participating in an msrb program, particularly because the program was augmented with a selfcompassion approach and perceived social support. participants reported a number of benefits resulting from the program, including subjective improvement in sleep, reduction in stress and anxiety, and increased calm. additionally, participants described acquiring a more positive perspective as it related to their caregiving responsibilities. this participant feedback suggests mindfulness/meditation may foster effective coping mechanisms for older adults struggling to manage age-related transitions while also providing care for others. specifically, older adult caregivers may use mindfulness/meditation to acquire tools that facilitate acceptance of the gradually changing roles and responsibilities between themselves and individuals for whom they provide care. further, mindfulness/meditation practice may also help to alleviate cumulative stress, anxiety and emotional burnout resulting from providing daily care, while allowing caregivers to identify new pathways for reaching shared understanding with those who rely on their support. as many older adult caregivers often contend with personal health challenges while functioning in a caregiving capacity, meditation/mindfulness potentially emerges as a vital resource for maintaining self-care. unlike mindfulness programs primarily based on mbsr, programmatic offerings for this study included a mindful self-compassion approach. the self-compassionate response, which encourages self-soothing or comfort during times of stress, as opposed to attempting to fix or control a problem, is related to improved well-being. such an approach may be ideal for caregivers, who often sacrifice their own needs in an effort to fulfill their caregiving responsibilities. participants' descriptions of their renewed commitment to self-care and adaptions to caregiving demands may be a result of this unique blend of the mbsr and self-compassion approaches. this is a promising finding, especially in light of the well-documented association between older adult caregivers' decreased self-care and negative behavior changes. the majority of participants reported subjective benefit they attributed to the practice of meditation or accompanying didactics. yet participant feedback also showed the interactive nature of the program, which allowed attendees to share about their experiences and exchange resources, created the benefit of rapport and a form of social support. even though the program emphasized didactics and practice, with less time allocated for the exchange of caregiver accounts, many participants described these opportunities as significant. further, this exchange of experiences, and the resulting sense of identification, made attending live sessions preferable to prerecorded sessions and allowed participants to feel better connected. given research that shows perceived social support may be a better predictor of subjective burden as compared to received support, this intervention potentially demonstrates how older adult caregivers may derive meaningful social support from an intervention with an online format, while participating from remote locations. highly accessible social support in this format may be especially beneficial for older adult caregivers with fewer options for received support during a pandemic such as covid- . while participants found it helpful to hear other attendees' experiences with providing care, they also benefitted from learning about new approaches, tips and resources they were previously unaware of. this finding confirms that subjective and objective burden are inextricably linked and may require dual treatment. when asked for suggestions to further refine this program, participants desired greater opportunity and time to continue shared discussions of caregiving as well as leads for additional, regional resources. given that perceived social support mediates the association between resilience and caregiver burden, caregivers may be best served by mindfulness interventions that address both dimensions for caregiver burden by providing an element of social support. our findings support previous research that indicates caregivers' endorsement of the mbsr curriculum, as well as the desire for active, ongoing participation after the initial -week training. the majority of participants reported a desire to continue and grow their existing mindfulness practice with the benefit of year's access to program resources. while these findings point to the intention to implement mindfulness as an ongoing habit, future studies should examine the degree to which participants adhere to consistent practice, especially as the trajectory for caregiving and related burden changes over time. further research should determine if the demonstrated benefits of participation persist beyond a standardized week program, and whether long-term mindfulness practice provides the same benefit and longitudinal mitigation of caregiver burden and related depressive symptoms. limitations of this study include recruitment of participants according to self-identification as caregivers, rather than assessment of caregiver burden. thus, participants represented diverse contexts of caregiving and may have derived varying benefit from their participation. additionally, this study's cross-sectional design does not allow for investigation of long-term intervention effects along the caregiving continuum. a larger, longer pilot study beyond weeks should examine how the needs of caregivers may evolve over time and the extent to which mindfulness remains efficacious. finally, social support emerged as a distinct benefit for participants. though this program afforded the opportunity for participants to interact with a larger community of caregivers, it may not be ideal for all older adults, particularly those who are lonely and may benefit from interactions outside the home. older adult caregivers experience significant subjective and objective burden, often while managing their own chronic illnesses. the online adaptation of a mindfulness program provides improved accessibility for caregivers otherwise unable to attend face-to-face sessions. the addition of a self-compassion approach may help caregivers identify constructive strategies for adapting to caregiving responsibilities and a renewed commitment to self-care. likewise, allowing participants to interact with a larger community of caregivers may provide perceived social support and positively influence both subjective and objective dimensions of caregiver burden. the sample used in this study was drawn from those who completed the program, and included participants with higher dosage than the overall study population of completers, which may represent a potential sample bias. subsequent studies may examine patterns of use and perceived outcome among a wider range of older adult caregivers with more varied experiences. this study's qualitative approach provides a nuanced, contextual account of older adult caregivers' experiences while participating in a mindfulness program. future studies may employ a randomized control design to objectively measure participant outcomes to yield generalizable findings. finally, future research should extend current findings with larger, longitudinal studies. office of disease prevention and health promotion the status of baby boomers' health in the united states: the healthiest generation? stigmatized and perpetual parents: older parents caring for adult children with life-long disabilities alzheimer's disease treatment and family stress: directions for research. us department of health & human services national alliance for caregiving relatives of the impaired elderly: correlates of feelings of burden a systematic review of caregiver burden following stroke subjective burden of 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distress the effect of mindfulness-based therapy on anxiety and depression: a metaanalytic review effects of mindfulnessbased stress reduction on medical and premedical students mindfulness skills and interpersonal behaviour mindfulness as a moderator of neuroticism-outcome relations: a self-regulation perspective mindfulness and interpersonal communication do deficits in mindfulness underlie borderline personality features and core difficulties? mindfulness based stress reduction (mbsr) for parents and caregivers of individuals with developmental disabilities: a community-based approach a pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia the effects of mindfulness-based stress reduction program on the mental health of family caregivers: a randomized controlled trial older adults and internet use. pew internet & american life project a pilot online mindfulness intervention to decrease caregiver burden and improve psychological well-being what is an adequate sample size? operationalising data saturation for theorybased interview studies naturalistic inquiry. sage data were saturated. sage characteristics of qualitative descriptive studies: a systematic review handbook of qualitative research qualitative inquiry and research design: choosing among five approaches nvivo qualitative data analysis software a pilot study and randomized controlled trial of the mindful self-compassion program predictors of decreased self-care among spouse caregivers of older adults with dementing illnesses social support and subjective burden in caregivers of adults and older adults: a meta-analysis resilience and burden in caregivers of older adults: moderating and mediating effects of perceived social support a pilot investigation of mindfulness-based stress reduction for caregivers of frail elderly we thank all co-authors for their critical review of this manuscript. the author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. the author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this work was funded by the supplemental health insurance program. la developed the study proposal; jh and ru conducted and interpreted the analyses; jh, ru, rt, js and erw wrote and reviewed the manuscript. an independent review board reviewed and approved all study activities. all authors are employed or contracted by united-health group or asi services, inc. however, their compensation was not dependent upon the results obtained in this research, and the investigators retained full independence in the conduct of this research. key: cord- -shog bx authors: larcher, vic; dittborn, mariana; linthicum, james; sutton, amy; brierley, joe; payne, christopher; hardy, hannah title: young people’s views on their role in the covid- pandemic and society’s recovery from it date: - - journal: arch dis child doi: . /archdischild- - sha: doc_id: cord_uid: shog bx objective: there has been little formal exploration of how young people see their role in the covid- pandemic. design/setting: focus-group discussion with children’s hospital young people’s forum members ( / ) to explore their perspective on the impact of covid- on both their lives and those of their community, on school closures, and the role they wished to play in society’s recovery from the pandemic. audio recordings were transcribed verbatim using nvivo software and analysed using an inductive thematic analysis approach. outcome: four major themes identified: ( ) awareness of pandemic’s impact on others: participants showed mature awareness of the effects on broader society, especially the elderly, socially disadvantaged and parents. ( ) perceived impact on their own lives: principal concerns were the educational and practical repercussions of school closures and social isolation, including effects on educational prospects. ( ) views about school reopening: young people understood the broader rationale for school reopening and were generally positive about it, but expressed concerned about their safety and that of others. ( ) communication issues: a need for clear, concise, understandable information readily accessible for young people was expressed. up to now, they felt passive recipients rather than participants. conclusion: young people were concerned about their future, their family and broader society, consistent with a high level of moral development. they want to be active participants in social recovery, including concepts around return to school but require appropriate information and a means by which their voices can be heard. the alternative suggested roles as pawns or pathfinders were discounted. in the uk and elsewhere, the response to the covid- pandemic has been 'guided by the science'. but the implication that there is one form of science whose facts should guide policy is erroneous, since medical, social and economic disciplines are all involved. moreover, science is not value-free, since inevitable disparities in scientific advice need to be resolved by judgements that are value-driven and which need to take into account the views of those involved if ethical principles of equal concern and respect are to be satisfied. the wider psychosocial and economic consequences of the pandemic are fast emerging. although young people (yp) have suffered less as a direct result of covid- disease than other vulnerable groups, for example, the elderly and bame (black, asian and minority ethnic) community, - the indirect impact on them has been marked. perhaps of more significant concern is the educational and psychosocial effects of physical distancing, social isolation and school closures on children's welfare. reopening of schools is, therefore, a key element in the recovery process, because of the benefits it brings, but it remains a matter of dispute. the broader role yp might play in the recovery process needs to be explored since they will, as adults, bear the economic and psychosocial consequences of the pandemic. yet there has been little formal exploration of how they view their roles in this process or of how their voices might be heard. to begin to address this, we explored the views of yp on the impact of the pandemic on both their lives and those of their community, on school closures and of the role they wished to play in recovery. ► sars-cov- has not severely clinically impacted children compared with other groups, yet they have been profoundly affected by control measures, for example, social distancing and school closures. ► the views of young people on the effects of the pandemic on society, and their role in recovery for it have been little explored. ► roles as partners, pawn or pathfinders in society's recovery from the pandemic have been suggested for young people; it is unknown which they think suitable. ► the main concerns of young people about the pandemic are its effects on others (known to them; the abstract vulnerable) and on their own education/future. ► young people do not consider roles as pawns or pathfinders in society's emergence from the pandemic as suitable, preferring to be partners. ► young people felt recipients rather than participants in the pandemic process; they need appropriate accessible information and means by which their voices can be heard. we conducted an audio-recorded focus-group discussion with available members ( - audio recordings were transcribed verbatim using nvivo software and analysed using an inductive thematic analysis approach. four major themes with subthemes were identified: yp comment: boxes and . . awareness of the impact on others: participants showed clear recognition of the effects of the pandemic and the imposed control measures on broader society, focusing mainly on three groups: the elderly, socially disadvantaged and parents. i. elderly and communication and technology challenges: participants were all technology proficient, being able to join a video-conference forum, but had experienced communication challenges with their more elderly relatives who often lacked skills to use online communication means: (p ). participants recognised this as a broader problem, including for those organisations that would typically support older people who were themselves now facing communication problems. ii. socially disadvantaged: participants were aware of challenges posed by social inequalities on those from underprivileged backgrounds. notably, they mentioned that students who lacked the required devices for homeschooling needed support and the provision of appropriate, updated and dynamic materials: (p ). iii. challenges for parents: participants discussed how competing responsibilities posed by school closure and working from home was challenging for their parents, who often lacked teaching skills and the time needed to support children with homework: (p ). i. school closure: many felt that home-schooling and online learning had been an overwhelming experience produced by such factors as the new format, the lack of peer interaction for discussion and education and lack of proper support from their teachers. participants expressed how support received was inadequate and slow regarding submission deadlines: (p ). ii. suspended grades: for those preparing for a-levels, with the need to obtain specific grades to progress to university, cancellation produced feelings of disappointment, impotence and uncertainty about their future, for which they had been working hard and looking forward. lack of clear guidance and information about how this will be managed contributed to concerns: (p ). iii. social isolation: regarding social isolation, participants mentioned difficulties with being unable to socialise faceto-face with their peers, with whom they would normally share their personal struggles, as expressed by this participant: (p ). participants also expressed challenges produced by the interruption of their usual coping mechanisms, such as sport or music activities. while some of them were adapting readily to new online formats, there were concerns about the significant amount of screen time to which they were now exposed. . yps' views about school reopening box synthesis of themes and subthemes from young people's forum focus-group discussion (i) "so, all of my grandparents are very social, but i think i found staying in quite hard, especially because they don't understand technology as well […] . so, none of them would be able to face time." (p ). ii. socially disadvantaged "they kind of came out and asked who had the provision to actually access the internet to do work. and i think for the people who didn't, they were given textbooks. and to me, that seems a little bit outdated and something that maybe isn't too useful because that's not a constant stream of information." (p ) iii. challenges for parents "but obviously, our parents don't know everything about things. so, then we try, and you google. but then when google doesn't give you the answer, then you rely on your parents. but your parents can't really teach you anything. so, you kind of feel bad because you can't do anything because you don't understand it, but they don't understand your work either." (p ) iv. schools' staff: this is included under school reopening concerns . the perceived impacts on their own lives i. school closure "we have been almost overwhelmed. i know i have. with the amount of work that's been set all at one time. and a lot of the teachers don't respond when you ask them for assistance with things we might be stuck on." (p ) ii. suspended grades "oh, i was going to have my a-levels this year, but obviously they got cancelled and it, kind of feels like the sort of rite of passage that kind of got them. yeah. for me that you don't get to go through, like because i want to do medicine. i've done so many things for the past two years. just as often leads up to and it's like you've built up all this momentum. but the end result and like thought of going through exams or just disappear so you don't have that place of relief for this sort of energy and everything that's been building up." (p ) iii. social isolation "so, it might be very hard for some people because we can't see our friends anymore. and i know that i haven't got much family, so my friends are more like my family and i depend on them. it's not being able to have that human contact in person is really hard." (p ) i. rationale: views toward school reopening were variable. some thought that this was necessary to allow parents to go back to work. in contrast, others considered this unsafe as children would be the first in society to have close contact with other people: (p ) ii. concerns: various anxieties were expressed about school reopening related to impracticable infection control measures, including social distancing steps, that would lead to risks for staff and any students' family members who might be at high risk of severe disease: (p ). iii. age groups' particular issues: most comments were concerned with year - returnees, rather than younger children, but a view concerning the impact on university students was also expressed: (p ). i. right to appropriately tailored information: participants agreed that yp had the right to receive information about the pandemic, but acknowledged the challenges associated with adapting it to recipients' needs and different age groups. however, they felt that comprehensive details should be provided while avoiding complicated wording and lengthy and confusing content: (p ). ii. problems related to available information: participants mentioned several issues with how information was being presented, which they felt was not explicitly aimed at a yp audience. many knowledge resources provided overwhelming and confusing amounts of data, with inconsistencies between government/institutions' official reports and what they saw shared on social media. however, they also identified the risk of fake news on some platforms, which concerned them due to the considerable uncertainty it could generate among yp. iii. linear communication model-yp as passive recipients: information was reportedly received from different channels, especially from schools: "[…] we've also been receiving weekly updates from the college." however, only a few mentioned that they had opportunities to express their questions and opinions. most participants agreed with the feeling of not having a voice during the pandemic or during the recovery process: (p ). iv. yp's participation in the recovery process: many expressed the view they should be part of this process, as they are and will be directly affected by the pandemic in multiple aspects of their current and future lives: (p ). they suggested various ways in which yp' voices could be heard: from looking at what yp are currently discussing and their opinions on social media and other platforms, in collaborative or national surveys by active representation and participation in the youth parliament, and in events like the current forum: (p ). we asked the yp to write a paragraph about being one of two yp authors on the paper, to reflect their contribution to the paper-judging only two proved incredibly hard, therefore we have elected to share these as an online supplementary file. (yp paragraphs) the discussion held in this focus group with yp provided remarkable insight on their awareness of moral issues concerning themselves, their families and the wider community, consistent with higher levels of moral development. they demonstrated knowledge of themselves over time in respect of future ambitions and need for education. additionally, participants expressed willingness to participate in the response and recovery process by actively looking for both information sources and means to voice their views. however, most acknowledged the lack of opportunities to express their opinions and actively participate in the process. the un convention on the rights of the child (uncrc) and the uk children act provide for the rights of children to express their views on matters that concern them, and for those views to be given due weight in accordance with their age, maturity and understanding. professional bodies such as the general medical council and royal college of paediatrics and child health have sought to involve yp in discussions about policy and other matters. the reason for yp's voices not being considered in the pandemic response and regarding recovery measures is unclear. it might be due to persistent notions of incomplete moral development and agency in this group, even though some children have shown the capacity for self-directed acts of box synthesis of themes and subthemes from young people's forum focus-group discussion (ii) "i don't think until mps are sitting together in the house of commons, i don't think we should be sitting together in school just because we're younger and we aren't at risk of having a more serious infection, doesn't mean we should be the first to have to fully go back and reintegrate. i don't think that is a really safe thing to do because that is a blanket." (p ) ii. concerns "there's obviously a lot of concerns about how the risk of infection will be strictly managed all day long because i know like at some schools there's key workers kids who all go in, and it's really good the social distancing. all-day long. but at the break and lunchtimes, there's no social distancing at all. so, all the kids go back together and then at pick up. all the parents are together as well." (p ) iii. age groups' particular issues "i was kind of a forgotten group of uni students in the sense that all unis have different policies about what they're doing. some are holding their exams; some aren't. and then the question of the future, they sort of forget the fact that we're all racking up nine thousand pounds every year, even if we're not allowed to go back." (p ) i. right to information-tailored "so, even if it's presented in a different way, you're entitled to the same information in life as an adult should be." (p ) ii. threats related to available information iii. linear communication model-yps as recipients only "they're not listening to children, young people much at the moment." (p ) iv. yp's participation in the decision-making process "i think that's a general view at the moment that it's going to affect this generation most with all the debt and everything that's building up out of this." (p ) "yeah. i was thinking maybe one way that children and young people could get their words heard was maybe a schools or youth group sent out like a q and a. and then the answers and their opinions were collaborative and maybe sent to mps or somebody higher up." (p ) kindness and altruism. participants in this focus group showed great ability to understand complex issues and, more importantly, expressed the need and willingness to actively participate, supporting the social and legal commitments to them represented in the above international and national standards/laws. although the participants were sophisticated in terms of their medical knowledge, gleaned from past experiences and participation in the ypf, they felt that the information that they had received was complicated, confusing and in some instances, contradictory. if this was the case for this group, it seems highly likely that it would apply to an even greater extent to those who lacked their experience and knowledge. again, this group demonstrated concern for others by suggesting strategies to alleviate this problem. this issue requires urgent attention with lack of transparent, appropriately presented and complete information impeding yp's participation in this process. initially, national debates about the covid- pandemic were primarily concerned with discussions about the medical science including the direct effect of the virus on vulnerable individuals and maintenance of critical care capacity, so little involved yp who were not perceived likely to be significantly affected. however, this is no longer the case given the recent identification of the paediatric multisystem inflammatory syndrome temporally associated with covid- , and the highlighting of the socioeconomic consequences of physical distancing, social isolation and school closures, and of now a recovery to the 'new normal'. children's issues, including how we must mitigate the profound detrimental effects on them as a social priority, is finally becoming clear. return to school has been an essential element in this because of the significant interruption of education that has occurred, the vital part played by schools in the psychosocial support and protection of vulnerable children, and the freeing of parents to contribute to the economy. participants in the focus group were aware and concerned that yp and younger children have been and will continue to be indirectly affected by the pandemic and the control measures imposed, notably social isolation, school closure and for older participants, the impact of suspended grades. after reading the jme paper about their potential role as pawns, pathfinders or partners in the recovery process, the comments made by the yp provided a clear indication of the position that they would wish to play in response to the pandemic. comments about the limited provision of relevant and accessible information, together with the almost complete lack of consultation of children throughout were indicative of passive 'pawn' role insofar as others made decisions on their behalf in which they had no active part. concerns expressed about their safety and that of others, together with the view that others should be taking similar risks suggested that they did not regard the 'pathfinder' role, even with safeguards, an attractive one. in contrast, general support for a more active partnership role was clear; this is undoubtedly consistent with pre-existing standards, especially the uncrc. to be clear, the need to make urgent difficult decisions in the national interest is a crucial role of government and we do not seek some plebiscite of those most affected (ie, teachers, yp and parents regarding school closures) before urgent decisions are taken. but we do argue that consultation of such groups ought to occur as soon as possible after any urgent action, and indeed before if there is time. we wish to highlight a few strengths and limitations to this study. there was a broad range of participants, all actively involved, which allowed the ypf to eloquently contribute to a little explored, hot topic affecting them. the presence of the authors of the provided paper might have made it more difficult to voice disagreement, though this was not the author's experience. although the aim was not to look for representativeness, this is a particularly educated and informed group in terms of prior involvement in, and experience of, child health issues. therefore, it is unclear how generalisable to other yp our findings are. there is a lack of information concerning the role of children and yp in the covid- pandemic response. from this limited study, it seems clear that yp have relevant concerns about themselves (especially their future), their family and broader society. they feel that they should have an active part to play in both return to school and the recovery process, though they have had little mechanism as yet to do so. they do not see themselves as either pathfinders or pawns, but rather partners in society's emergence from the pandemic. twitter vic larcher @viclarcher ethical road map through the covid- pandemic guidance: responding to covid- : the ethical framework for adult social care mitigating the wider health effects of covid- pandemic response risks to children and young people during covid- pandemic covid- ) related deaths by ethnic group sars-cov- infection in children coronavirus disease in children -united states the effects of social deprivation on adolescent development and mental health school closure and management practices during coronavirus outbreaks including covid- : a rapid systematic review children of covid- : pawns, pathfinders or partners? using thematic analysis in psychology united nations general assembly. convention on the rights of the child uk public general acts not just a phase. a guide to the participation of children and young people in health services clinical characteristics of children with a pediatric inflammatory multisystem syndrome temporally associated with sars-cov- paediatric inflammatory multisystem syndrome: temporally associated with sars-cov- (pims-ts): cardiac features, management and short-term outcomes at a uk tertiary paediatric hospital contributors jb conceived the project after email exchange with the editor in chief. vl and jb wrote the jme paper and blog which the ypf read before the focus group. as leads the yp, and with md and jl organised the focus group and contributed to the paper. md and vl transcripted and jb, vl and md analysed the data. all yp were invited to comment on why they might be authors, and we think they are all so good we include as an addendum. all authors approved the final manuscript.funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.competing interests none declared. provenance and peer review not commissioned; externally peer reviewed.data availability statement data are available on reasonable request. the data consist of the full transcripts, the audio recording has been destroyed.this article is made freely available for use in accordance with bmj's website terms and conditions for the duration of the covid- pandemic or until otherwise determined by bmj. you may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. joe brierley http:// orcid. org/ - - - key: cord- -m sr oc authors: denburg, avram e.; ungar, wendy j.; chen, shiyi; hurley, jeremiah; abelson, julia title: does moral reasoning influence public values for health care priority setting?: a population-based randomized stated preference survey date: - - journal: health policy doi: . /j.healthpol. . . sha: doc_id: cord_uid: m sr oc objective: preferences of members of the public are recognized as important inputs into health care priority-setting, though knowledge of such preferences is scant. we sought to generate evidence of public preferences related to healthcare resource allocation among adults and children. methods: we conducted an experimental stated preference survey in a national sample of canadian adults. preferences were elicited across a range of scenarios and scored on a visual analogue scale. intervention group participants were randomized to a moral reasoning exercise prior to each choice task. the main outcomes were the differences in mean preference scores by group, scenario, and demographics. results: our results demonstrate a consistent preference by participants to allocate scarce health system resources to children. exposure to the moral reasoning exercise weakened but did not eliminate this preference. younger respondent age and parenthood were associated with greater preference for children. the top principles guiding participants’ allocative decisions were treat equally, relieve suffering, and rescue those at risk of dying. conclusions: our study affirms the relevance of age in public preferences for the allocation of scarce health care resources, demonstrating a significant preference by participants to allocate healthcare resources to children. however, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access. definitions of value in healthcare based on clinical benefit and cost-effectiveness may exclude moral considerations that the public values, such as equality and humanitarianism, highlighting opportunities to enrich healthcare priority-setting through public engagement. faced with both scarce resources and pressures to keep pace with innovation, health systems in most developed nations emphasize the comparative value of health interventions in payment policies and coverage decisions [ , ] . such appraisals of value rely on assessments of clinical efficacy, economic efficiency and, increasingly, societal values. growing recognition that democratic commitments warrant more room for public voice in health and social policy decisions particularly when allocating public resourceshas spurred attempts to incorporate citizens' values and preferences in health technology assessment (hta) in an increasing number of developed countries [ ] . while approaches to measuring clinical and economic value are wellspecified, the means of identifying and assimilating relevant societal values in hta are not [ , ] . to bridge this gap, a growing academic literature has sought to address the measurement and interpretation of societal value judgements for health system priority setting. two contrasting approaches to the elicitation of societal values have prevailed: population-based surveys and exercises in deliberative engagement. both admit of strengths and limitations. while survey methods are able to elicit preferences from a large swath of the public, they often preclude in-depth reflection and discussion about the complex ethical issues involved in setting priorities [ , ] . by contrast, deliberative engagement with patients or publics offers rich opportunities for nuanced and recursive consideration of the values that motivate allocative decisions, but from the bounded perspective of a small and select group of persons [ ] . a few attempts have been made to marry deliberative and survey methods, either by bookending deliberative events with survey questions or by embedding opportunities for deliberation within survey designs [ ] [ ] [ ] . we adapt an approach to the latter to investigate societal preferences for allocating health care resources to children as compared to adults. age represents one of the most prominent issues explored in the literature on social values for health system resource allocation [ ] [ ] [ ] [ ] [ ] [ ] . the focus on age stems in part from the utilitarian assumptions that anchor prevailing methods of health economic evaluation [ , ] . qualityadjusted life years (qalys) have played a dominant role in assessing the value of health interventions, as a universal metric for comparisons of benefit among different technologies that incorporate quantity and quality of life into a unified indicator. closely allied to the use of qalys as an outcome measure in applied health economic evaluation is the assumption of utilitarian qaly maximization as a normative goaland thus decision-criterionwhen selecting the best alternative among competing interventions [ ] . the prominence of qaly maximization as a decision-criterion in applied health economic evaluation, including by hta institutions internationally, has prompted theoretical and empirical inquiry into the strength of societal preference for qaly maximization [ ] [ ] [ ] [ ] . moral philosophers and social choice theorists have challenged the moral legitimacy of purely consequentialist approaches to health care rationing, including qaly maximization, citing the relevance of ethical concepts ranging from distributive justice, priority to the worst off, and rightsbased entitlements in health resource allocation [ ] [ ] [ ] [ ] [ ] [ ] . empirical studies of public preferences for health care resource allocation often employ recipient age as a proxy for qaly gains. studies of public preferences have yielded considerable evidence favouring priority to younger populations [ ] [ ] [ ] [ ] . such studies have often compared adults of various ages; select studies include a childhood age range among their comparators ( , ( ) ( ) ( ) ( ) . however, few studies have explored public preferences for health resource allocation decisions related to children as such. underlying societal preferences for health resource allocation: ) 'health maximization ageism' (constant relative value of life-years, irrespective of age); ) 'productivity ageism' (higher value of life-years in young adulthood, related to greater social and economic productivity); and ) 'fair innings ageism' (emphasis on opportunity for equal aggregate lifetime health (or qalys) through priority to those expected to experience less, such as the young or disadvantaged) ( ) . each of these approaches is outcome-oriented and concerned with health gains, though calibrated to prioritize different groups based on alternative ethical arguments. 'health maximization ageism', which corresponds to pure qaly maximization, receives its strongest support in age-based stated preference studies that focus on life-saving interventions, or those that result in more aggregate qalys for younger recipients. even so, evidence for societal disavowal of pure qaly maximization exists, with some studies yielding majority preferences for equal allocation in the face of discrepant potential qaly gains across age groups ( , ) . importantly, studies that test preferences for age-based allocation in terms of qaly maximization alone cannot discern whether distinct moral principles inducing priority to the young (be it children or younger adults) are at play. when controlling for qalys gained, the evidence in support of priority to younger groups is mixed. stated preferences consistent with both 'fair innings ageism' and 'productivity ageism' are evident in select studies examining age-based trade-offs in the context of fixed benefits. when the duration of benefit across age groups is standardizedthereby in effect neutralizing 'health maximization ageism', or pure qaly maximizationconsistent prioritization by age breaks down, with participants alternately preferring allocation to children, people in middle age, or equal allocation across age groups ( ) ( ) , ( ) ( ) . it is, however, often difficult to disentangle evidence in support of one of these forms of ageism from the other in the extant literature. in addition to studies of age-based priority setting that focus on health outcomes, a number of studies explore the moral bases for allocative decision-making by examining the relevance of causes. anand and wailoo demonstrate weak societal preference for consequentialist rationing rules, including qaly maximization, through experimental rationing decisions that force tradeoffs between hypothetical adult recipients of different ages ( ) . notably, they also empirically examine the relevance of deontological considerations in health care rationing, including personal responsibility for one's health state, socioeconomic status, and procedural considerations in priority setting. their work demonstrates a disavowal by participants of pure qaly maximization, and highlights other salient normative considerations for potential incorporation into rationing exercises, including equality of treatment, individual rights and duties, and procedural fairness ( , ) . relatedly, a limited body of evidence points to the impact of embedded moral reasoning on attenuated public preference for the young, suggesting that deliberation on a range of ethical principles can influence stated preferences for allocating resources based on age ( ) . however, this evidence pertains to age variations amongst adults. j o u r n a l p r e -p r o o f despite this focus on age as a morally relevant variable, the extant literature contains little dedicated inquiry into allocative preferences regarding children per se ( ) . this lack of evidence has contributed to a vacuum of both theoretical and context-specific knowledge about societal preferences related to the prioritization of health system resources for children. the need for more and better knowledge of public values attached to health care priority-setting affecting children is underscored by inherent challenges associated with the assessment of child health technologies [ ] [ ] [ ] . health system funding decisions for children are often constrained by limited evidence for the clinical efficacy or economic efficiency of child health technologies [ ] . childhood diseases are typically rare, the conduct of research in pediatric populations is complex, and standard metrics of clinical and economic assessment fail to incorporate unique dimensions of childhood, such as family context and life-course impacts [ , ] to better understand societal values for health resource allocation, we conducted a population-based stated preference survey with a nested randomized controlled moral reasoning intervention. our objective was to generate evidence to inform economic evaluation and policymaking on health care priority-setting and payment reform in developed health systems. uniquely, we sought to explicitly assess societal preferences for allocation to children, and to test j o u r n a l p r e -p r o o f the influence of structured deliberationin the form of an individual-level moral reasoning exerciseon allocative preferences. our principal aims were to: ( ) understand the direction and strength of public preferences for health resource allocation between children and adults for varied treatment scenarios, ( ) assess the impact of a moral reasoning intervention on the expression of such preferences, and ( ) identify sociodemographic factors that impact the expression of public preferences on health resource allocation between children and adults. we also sought to test the divergence of participant preferences for children or adults from an assumption of age-neutrality, to understand the treatment scenarios within which significant preferences for either children or adults emerge. finally, we aimed to characterize the principles that most influenced participants' allocative decisions, to gain a deeper understanding of the moral reasoning behind societal preferences for health resource allocation. in keeping with much of the prior literature on age-based resource allocation, we expected that control group participants would display an aggregate mean preference for allocation to children, particularly in scenarios where theoretical qaly gains were largest (i.e. cancer treatment and eating disorders therapy). in scenarios with fixed and equal life-year gains across children and adults (i.e. chronic disease drug, liver transplant), we hypothesized that participant preferences for children would be less pronounced, but persist on average, due to intuitive conceptions of 'fair innings'. we included a palliative care scenario to test the direction and strength of age-based preferences in a context focused on relief of suffering rather than hypothetical qaly gains, anticipating weak or no preference for allocation to children. in terms of participant sociodemographics, we presumed that younger adults and those with children of their own would j o u r n a l p r e -p r o o f preferentially favour allocation to children, due to temporal and emotional proximity to childhood states. in contrast to prior evidence demonstrating diminished preference for younger adults induced through moral deliberation [ ] , we hypothesized that a moral reasoning exercise would increase the strength of public preference for allocation to children, as compared to adults. this hypothesis was predicated on insights from foregoing normative analyses of public policies for children, which have identified distinguishing characteristics of childhoodsuch as vulnerability, dependency, rarity, social distinction, and future potentialas drivers for policy development [ ] [ ] [ ] [ ] [ ] [ ] . we postulated that the moral reasoning exercise, which incorporated a number of valuesbased considerations specific to children, would prompt participants to consider their allocative preferences in light of these unique concerns. given the ethical tools to unpack intuitions about what children might deserve relative to adults, we anticipated that participants randomized to the moral reasoning arm would apprehend justifications for preferential allocation to children that may not be immediately apparent. we further hypothesized that participants in the intervention arm would display stronger aggregate preference for children across all the clinical scenarios tested, regardless of the duration of life years gained, as a result of their access to a varied palette of ethical principles by which to justify preferential allocation to children, including vulnerability, dependency, potential, and social distinction. we conducted a population-based stated preference survey of societal views on the prioritization of health resources among children and adults, administered to a non-probability sample of j o u r n a l p r e -p r o o f canadian adults. participants were recruited through letters of invitation emailed to a random sample from a panel of over one million canadians maintained by a survey research firm. a limitation of non-probability sampling is the absence of general statistical theory to predict sample representativeness from survey design assumptions [ ] . to minimize sampling bias and maximize the potential for national population representativeness, we employed interlocking quotas for stratified sampling (age, gender and region), balanced against statistics canada norms, and evaluated the composition of our final sample in comparison to the canadian population on a range of sociodemographic characteristics. the survey was web-based and loyalty program rewards were offered to encourage participation. development of the survey instrument drew on prior literature on the ethics of health resource allocation and social values relevant to child health policy. the principles included in our moral reasoning exercise were derived from a systematic review of the literature on social values relevant to child health and social policy, refined through an in-depth qualitative case study of health technology assessment and policymaking for children in canada [ , ] . iterative refinements to the survey were informed by a pilot phase with experts (n= ) and laypersons (n= ) and field testing with members of the public (n= ). the final survey questionnaire directed respondents to assign numerical preference scores for the allocation of resources in different health care scenarios based on age-related criteria. it presented each participant with the same five hypothetical treatment scenarios (chronic blood disease, liver transplant, cancer therapy, palliative care, and eating disorder); these scenarios were intended to provide variation in disease characteristics such as acuity, morbidity, mortality, potential for cure, and nature of participants chose between funding for treatment among adult (average age ) and child (average age ) patients, from the perspective of a citizen advisor to a health system administrator. preferences were captured as continuous variables on a visual analog scale (vas) from - (full preference for children) to + (full preference for adults), with zero representing neutrality. we employed a vas design to explore changes in the strength of participant preferences for children or adults in order to capture more subtle variation in preference than would have been possible with categorical choices, while still allowing for preference neutrality. demographic data related to age, sex, income, education, employment, health status, and family structure were collected. randomization of participants to either an intervention or control group was achieved via a leastfill approach, employing computational logic to assign respondents to the group with the lowest current quota count, which enabled random assignment with respect to stratification variables (age, gender, region). we subjected participants in the intervention group to a moral reasoning exercise prior to each choice scenario. the exercise presented subjects in the intervention group with a list of twelve ethical principles relevant to allocative decisions ( figure ). we fashioned principles to capture concepts identified as uniquely germane to health resource allocation involving adults and children, including 'fair innings', vulnerability, dependency, future potential, and distinction, as derived from a foregoing systematic review of social values relevant to health and social policy for children [ ] . balance was sought between principles that might inherently favour allocation to either children or adults. participants in the intervention arm were j o u r n a l p r e -p r o o f asked to select the three principles that most influenced their choice in each scenario. subjects in the control arm responded to the choice scenarios without exposure to a moral reasoning exercise. to minimize question order bias, we randomly rotated the order by which health care scenarios were presented to participants; in addition, we randomly rotated the order of principles within the moral reasoning exercise for the intervention cohort. participants were prevented from revising their prior responses as they proceeded through the questionnaire. quantitative survey data were imported into sas (version . ) for analysis. descriptive statistics were employed to characterize the respondent population and compare groups using the student's t-test for continuous variables (age) and chi-squared for categorical variables. we compared select sociodemographic variables from the overall sample with general canadian population demographics from the statistics canada census of population using onesample proportion tests [ ] . we employed a linear mixed-effects random intercept model, which allows for modelling of correlated continuous data, to analyze the strength of participant preferences for each of the scenarios presented and examine the impact of experimental group, scenario, and sociodemographic variables on mean preferences scores, while accounting for the correlation between repeated measures within the same subject. the model examined: ) the difference in mean preference scores by group, scenario, and demographic characteristics and ) the difference in mean preference scores between the intervention and control for each scenario. we analyzed the interaction of group and scenario on preference scores to understand whether group mean preference scores varied by scenario type, controlling for covariates (including age, geographic j o u r n a l p r e -p r o o f region, gender, language, education, employment, income, health, and family structure) (emethods). to further characterize the strength of participant preferences for children or adults, and explore potential choice uncertainty, we analyzed the proportions of respondents displaying any allocative preference beyond the bounds of a 'neutral' construct (zero midpoint), and modelled differences in neutral versus preferential responses as a binary outcome between groups and across scenarios through generalized estimation equation (gee) modelling. odds ratios with % confidence limits were computed to indicate the likelihood of a neutral response for each scenario, using chronic disease as the reference scenario. gee was also used to assess the likelihood of a neutral response by experimental group in each scenario, with moral reasoning as the exposure. lastly, we quantified the proportion of respondents selecting each allocation principle overall and by scenario. we tested equality of proportions across scenarios to detect significant differences in the proportions of respondents selecting a given allocative principle. chi-squared analyses were used to compare the proportions of participants selecting each moral reasoning principle in a given scenario, using one scenario (chronic disease) as a referent. mcmaster university. informed consent was obtained online as part of the survey panel opt-in process prior to individual survey initiation. the authors received no funding related to study design; collection, analysis, and interpretation of data; the writing of the report; or the decision to submit for publication. between april and , , a total of , individuals were screened for inclusion: , were deemed ineligible or declined to participate and , individuals were randomized. of these, we excluded , for incomplete surveys. a total of , ( . %) respondents completed the survey; were subsequently excluded for poor quality (e.g., racing). our final sample included , participants, with in the intervention group and in the control group (efigure ). respondent characteristics were similar across groups (etable ). as compared with canadian population census data, our sample evinced an overrepresentation of individuals with higher educational attainment. we present our results in sequence corresponding to the hypotheses listed above. we begin with an exposition of control group results, to ascertain whether a baseline predilection for allocation to children was apparent in our sample, and how it varied across disease-specific scenarios. we then move to analysis of mean preference scores in the intervention group, and observed differences between the intervention and control group, to isolate the impact of the moral reasoning exercise on participant preferences. our analysis of preference divergence from an age-neutral construct (- . to + . ) follows, to test the strength of allocative preference in either direction. finally, we analyze participant choices about the moral principles guiding their allocative preferences, focusing on the frequency and patterning of principle selection across scenarios. allocative preferences analysis of mean preference scores demonstrated a consistent aggregate preference by control group participants to allocate scarce health system resources to children across all trial scenarios ( figure ; table ). the strongest control group preference for children was observed in the cancer therapy (- . , % ci - . to - . , p< . ) and eating disorders treatment (- . , % ci - . to - . , p< . ) scenarios, in which the theoretical qaly gains were largest. mean scores were statistically significantly higher (more positive) in the intervention group overall, suggesting a weaker preference for allocation to children in those subjected to the moral reasoning exercise (figure ; table ). in the intervention group, a significant preference for allocation to children was retained in the cancer therapy (- . , % ci - . to - . , p< . ) and eating disorder treatment (- . , % ci - . to - . , p< . ) scenarios, but there was no age preference in the chronic disease drug, liver transplant and palliative care scenarios ( table ) . when analyzing the difference in mean preference scores between experimental groups for each scenario, the intervention had the largest absolute impact for the cancer therapy ( . , % ci where the benefits of an intervention were most obvious and different between adults and childrenas they were in respect of life-years gained from cancer and eating disorders therapy -j o u r n a l p r e -p r o o f a choice to prioritize those benefitting most may have seemed easiest, even in the face of exposure to competing moral principles. this explanation is supported by theories of rational decisionmaking from the field of cognitive psychology that posit dual-process thinking, distinguishing intuition from reasoning [ ] [ ] [ ] . the design of our studyincluding the survey format and pacing, question framing, and lay samplemay have induced intuitive responses from some participants, in the face of complex moral problems characterized by inherent uncertainty. in particular, participants may have allowed more obvious differentiators, such as discrepant benefits in length of life, to intuitively shape their preferences, rather than take the time and cognitive effort to work through conflicting moral choices in a rule-bound manner. this is likely particularly true of those unexposed to the moral reasoning intervention, and might explain why preference score differences between the intervention and control groups were largest in respect of cancer therapy and eating disorders treatment. it may also explain why variance in preference scores narrowed consistently across scenarios in the intervention group as compared to the control group: it is possible that this reduction in variance represents a reduction in choice uncertainty, in the context of enhanced participant reliance on analytical reasoning induced by the study intervention. proportions of neutral response (score between - . and + . ) were consistently higher in the intervention group across all scenarios (etable ). univariate gee analysis revealed the impact of the moral reasoning intervention on preference neutrality across children and adults, with neutral responses significantly more likely in the intervention group than the control group we made a conscious attempt to incorporate principles related to an array of individual and societal benefits and costs, to induce reflection on the range of moral reasons one might consider germane to health system resource allocation. we also sought balance between principles that might intrinsically engender preference for children or adults. participants exposed to the moral reasoning exercise demonstrated remarkable consistency in their prioritization of principles for allocative decision-making. the top three principles guiding participants' allocative decisions were: ) treat equally ( . % - . %), ) relieve suffering ( . % - . %), and ) rescue those at risk of dying ( % - . %). in all cases except palliative care, 'treat equally' ranked number j o u r n a l p r e -p r o o f one, with a proportion uniformly greater than %; subjects deemed 'relieve suffering' most important ( . %) in the context of palliative care, followed closely by 'treat equally' ( . %). the least endorsed principles ( %) for assigning allocative preference were: priority to rare diseases, priority to special populations, and priority based on societal productivity. despite consistency in ranking of principles, the proportion of participants selecting a given principle to guide allocative decision-making varied significantly across scenarios ( table ). as compared to the chronic disease treatment scenario, the cancer therapy scenario prompted significantly more participants to cleave to principles that, in theory, justify preferential allocation to children: opportunity to live a full life ( . % vs . %, p< . ), duration of benefit ( . % vs . %, p< . ), and concern for special populations ( . % vs . %, p< . ). they also tended to disavow principles favouring allocation to adults, including family responsibilities ( . % vs . %, p< . ) and economic productivity ( . % vs % p< . ). a similar pattern was observed for the eating disorder treatment scenario, with the addition of vulnerability ( . % vs . %, p< . ) to the principles endorsed. by contrast, in the palliative care scenario, participants displayed significantly more concern for equality of treatment ( . % vs . %, p< . ) and relief of pain and suffering ( . % vs . %, p< . ), and less concern for 'fair innings' (the entitlement to a full lifespan) or duration of benefit. a principal finding of our study is the consistent preference for allocation to children across health care scenarios in the overall cohort. this finding is in keeping with much of the extant evidence on societal preferences for allocation to the young, but adds depth and specificity in preference in response to changes in the duration of benefit from a given intervention [ ] . in the face of life-long benefits (e.g. life-saving interventions), their study participants gave consistent precedence to younger groups when allocating scarce resources. by contrast, when juxtaposed with life-long benefits, fixed benefits induced a preference pattern that privileged young to middle adulthood. our results may indicate similar moral intuitions behind participant choices, though with the notable difference of an equal allocation option. where pure qaly maximization was possiblenamely, in the cancer therapy and eating disorders treatment scenariosparticipants seemed to adjudge the life-long benefits that would accrue to children too large to overlook. conversely, in the scenarios with fixed benefits, preference for allocation to children was weaker in the control group, and a trend toward preference for equal allocation j o u r n a l p r e -p r o o f emerged in the intervention cohort. an alternative explanation could be that participants perceived scenario-specific differences in duration of benefit more readily than other benefits that, though not explicitly mentioned, also retain moral relevance in the context of these and similar scenarios. such benefits could include reduction in inequality of outcomesfor instance, founded on inherent characteristics of the disease (rarity) or population (vulnerability, dependency)or equitable chances to live a full life ('fair innings') [ ] [ ] [ ] [ ] [ ] [ ] . interestingly, our results at once confirm and challenge prior evidence that suggests decision-making from an impersonal vantage point (e.g. a budgetary decision-maker) makes it easier to discriminate in favour of one group as against another. nord et al. elicited allocative preferences from study participants within two different assumed perspectives: a 'veil of ignorance', in which the participants themselves might need the health intervention in question one day; and a health system administrator role, in which they were tasked with decisions about resource allocation to others from a budgetary standpoint [ ] . they found that the tendency to privilege younger people in allocative decisions was more evident amongst those who assumed the latter perspective, and argued that the degree of emotional remove induced by the shift in perspective might account for this difference. evidence from our study for the moderating effect of a moral reasoning exercise on participant preferences for allocation to children, from an administrative perspective, suggests the opportunity for ethical reflection mitigated participant willingness to discriminate between groups on the basis of age. this may reflect choice uncertainty and a resultant instinct for preference neutrality, rather than evidence of real, rich moral deliberation. alternatively, this may represent a 'depersonalizing' effect of moral deliberation on allocative decision-making, one sufficient to impact societal preferences for health resource allocationbut in the opposite direction to that observed by nord et al. counter to our hypothesis, exposure to a moral reasoning intervention diminished participant preferences for allocation to children. evidence of a moderating effect of moral reasoning on allocative preference for children suggests the opportunity for ethical reflection mitigated participant willingness to discriminate between groups on the basis of age. this relationship may have been driven by a more varied set of ethical principles with which to draw conclusions. interestingly, this is the same consideration that motivated our hypothesis of increased preference for children through moral reasoning. we presumed that the ethical nuances attached to funding health interventions for childrenincluding distinguishing features such as vulnerability, dependency, neglect, and future potential, that stood out in prior normative analyses of child health and social policywould come through more clearly to participants when exposed to a range of principles touching on them [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . notably, the strength of preference for equal allocation increased among those randomized to the moral reasoning exercise. one interpretation of this is that the intervention prompted participants to evaluate the relationship between their moral intuitions and their stated preferences, and induced a reasoned judgment about the importance of equality as a guiding principle for resource allocation. an alternative explanation is that, despite the study intervention, it remained cognitively difficult for participants to reason through the uncertainty inherent in weighing competing moral principles. the greater predilection for neutrality in the experimental group may have represented retreat to equality in the face of difficult choices. our study admits of potential limitations. in relation to the survey instrument, the brief statements used to evoke the meaning of each principle may have failed to capture its ethical nuances. different framing of the principles may have led to different patterns of preference among participants; however, randomly varying the sequence of principles mitigated any ordering effect bias [ , ] . use of a continuous scale overlapping zero to measure the strength of allocative preferences in the context of a binary choice task (fund either intervention a or b) may have led some participants to misinterpret zero as a choice to allocate equal sums of money to each population, rather than agnosticism about which intervention to fund. we sought to mitigate this potential limitation through simple, explicit scenario instructions; however, it is possible that misapprehension of the 'neutrality of preference' state by some participants impacted our results. the study was not designed to measure the time it took to read the principles in the moral reasoning intervention separately from completing the choice tasks. this could have given a proxy sense of whether participants read and engaged with the ethical ideas and choices involved. the assembly and composition of our study sample may have also limited the external validity of our results. values endorsed by the canadian public may not reflect those of other polities. the use of covariate-adaptive randomization to form balanced treatment groups with respect to relevant covariates has both benefits and inherent shortcomings; use of stratified randomization may have permitted some selection bias and only balanced a limited number of potentially relevant covariates [ ] . more specifically, the survey firm generated cohorts from an opt-in panel of eligible canadians recruited and incentivized through brand loyalty points programs. some of the inherent selection bias associated with online opt-in panels was evident, privileging those with higher education who are web literate. however, the lack of statistically significant impacts of education and income on preference scores in the multivariate model attenuates theoretical concerns about sociodemographic bias. our study also has important strengths. it is, to our knowledge, the first to experimentally examine the values behind health and social policy decisions about children, their valence in relation to adult needs and priorities, and their stability in the face of moral deliberation. its randomized design and large, heterogeneous population-based sample allowed for robust conclusions about the effect of the intervention on participant preferences. our findings demonstrate a convincing relationship between exposure to a range of relevant moral principles and the priorities set. this affirms the complexity of such decisions and the impact of ethical deliberation on them. these findings challenge reflexive trust in survey-based preference elicitation, and imply the need to complement such modalities with deliberative modes of public engagement on questions of social importance, such as the allocation of scarce public resources. in policy terms, our work both supports and challenges conceptions of value in health care based primarily on qaly maximization. dominant modes of health economic evaluation privilege interventions that maximize aggregate individual and societal utility, typically in the form of the duration and magnitude of benefits reaped and the size of the population reached. our results demonstrate a stronger preference for children in the hypothetical scenarios (cancer and eating disorders) in which the duration of benefit accrued mainly to children; this may represent an underlying motivation by participants to maximize benefits. however, we also observed a strong inclination for equality and humanitarianism amongst study participants, regardless of experimental group. the three principles deemed most salient to priority-setting were equal treatment, relief of suffering, and rule of rescue. none of these prioritizes age as a relevant variable; each starts from a belief in the intrinsic value of all human life, and resists grading that j o u r n a l p r e -p r o o f value by social context or circumstance. our results, therefore, suggest the need to incorporate other values into health care priority-setting, as some value frameworks for funding decisions have begun to do [ ] . the salience of these findings to priority-setting efforts in the context of public health emergenciesincluding access to scarce ventilators or drugs in the context of the covid- pandemicis readily apparent. they furnish empirical evidence for the adjudication and refinement of ethical frameworks for triage and resource allocation during the pandemic based on public values in canada [ , ] . efforts to incorporate a broader range of public values and preferences in health and social policy decisions also involve inherent risks. among them is the need to confront and grapple with public attitudes that conflict with the fundamental normative or legal principles that structure most democratic societies, including basic commitments to the protection of individual rights and nondiscrimination [ ] . future research to explore this tension and ways to resolve or address it is warranted. allied to this, our study affirms the importance of process in health care priority-setting exercises. the opportunity to explicitly consider varied normative ideas appears crucial to informed allocative decisions based on public values. the observed changes in public preferences in the face of competing moral principles imply the impact, and potential relevance, of structured opportunities for moral reasoning when making such consequential decisions. this includes the potential value of deliberative public engagement to health policymaking, particularly in domains where distinct ideas about the public good may compete. specific to children, few efforts to incorporate public deliberation in research and policy on child health and social policy priorities have prevailed to date. in the face of resource scarcity, evidence-informed child health and social policies will depend on the careful elicitation and integration of public values. this and allied work bear potential relevance in social policy domains beyond health, including public attitudes to j o u r n a l p r e -p r o o f 'deservingness' attached to welfare state distributional policies in domains as diverse as labour markets and education [ ] [ ] [ ] [ ] [ ] [ ] [ ] . crucial future areas of inquiry and application include the inclusion of child voices in research and policymaking, and the exploration of social values for priority setting within public policies and programs for children. our study underscores the relevance of age in public preferences for the allocation of scarce health care resources, extending evidence of this calculus to trade-offs involving children. nevertheless, it demonstrates the mutability of such preferences in the face of structured moral deliberation. this finding has three main repercussions. it furnishes a critical lens for the interpretation of stated preference surveys; introduces a note of caution into dominant modes of health care funding allocation decisions premised on utility maximization; and implies the value of deliberative methods as a complement to both. we observed a strong inclination for equality and humanitarianism amongst study participants, regardless of experimental group. these moral impulses prevailed over consequentialist logic, including priority to the young founded on aggregate benefit. the stability of these principles in the face of changing allocative preferences signals their importance as public valuesbut it also hints at the complexity of values-based decision-making. the public seems, at face value, to believe in equality of access and defend a set of shared human entitlements to care. it also seems to assign intuitive priority to children. the challenge of reconciling these convictions demands processes nimble enough to negotiate this paradox. spaces for moral deliberationwhether in large-scale surveys or focused qualitative engagementare essential to arrive at health care priorities that reflect what we collectively hold dear. j o u r n a l p r e -p r o o f contributions: ad conceived and designed the study. sc and ad performed the statistical analysis. ad prepared the first draft of the manuscript. all authors contributed to study design, critically revised the manuscript, and approved the final version. as corresponding author, ad accepts responsibility for the work, had full access to the data, and controlled the decision to publish. ad attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. acknowledgements: during the period of this research, ad was supported by grants from the canadian institutes of health research, pierre elliott trudeau foundation, canadian child health clinician scientist program, and pediatric oncology group of ontario. imagine that two different medicines are available to manage an incurable chronic blood disease: one drug treats the child form of the disease, while a different drug treats the adult form of the disease. without treatment, patients die of the disease within months of diagnosis. with drug treatment, both child and adult patients can be expected to live about years from diagnosis, after which they usually die from progressive complications of the disease. each drug costs the same amount of money and would serve the same number of people. the health system can only afford to fund one of the two drugs at present, and cannot split the money between the two drugs. please slide the bar to any point on the scale from - to + to show your strength of support for funding one of the drugs. a drug is available for patients with childonset blood disease. a drug is available for patients with adultonset blood disease. patients live about years with the treatment, at which point they usually die of complications from the disease. without the drug, the disease causes death within months. without the drug, the disease causes death within months. fund treatment based on evidence that it works  "fund treatments best proven to be safe and effective."  "since it is harder to study treatments in children, evidence is usually stronger for adult treatments."  "the older patients have had their turn."  "give the younger patients a chance for a full life." treat people who will benefit longer  "giving the treatment to the younger group makes sense, since they will enjoy it longer."  "lifelong potential should be factored into decisions about which health interventions to fund."  "at , people may be raising families or have others who rely on them."  "resources should be directed to help those that cannot protect or advocate for themselves."  "children are still developing, so can suffer lifelong consequences from untreated disease." treat people who are productive  "helping people who are in the workforce has benefits for all." treat everyone equally  "all patients deserve equal access to medical care."  "both groups should have the same chance." treat those who are dependent on others  "children are dependent on their parents or caregivers, so their illness has direct impacts on the lives of others." r : the full model with predictors explained . % of within-subjects variance and . % of between-subjects variance, as compared with the null model (without predictors). comparing the full model with a parsimonious model (non-significant predictors removed), the two models were almost identical. the parsimonious model explained . % more of the between-subjects variance; there was no difference in within-subjects variance explained. details omitted for double-blind reviewing making the case for value-based payment reform in children's health care details omitted for double-blind reviewing health technology funding decisionmaking processes around the world: the same, yet different details omitted for double-blind reviewing effect of discussion and deliberation on the public's views of priority setting in health care: focus group study details omitted for double-blind reviewing democracy and deliberation considered opinions: deliberative polling in britain can a moral reasoning exercise improve response quality to surveys of healthcare priorities which of two individuals do you treat when only their ages are different and you can't treat both the utility of health at different stages in life: a quantitative approach is the valuation of a qaly gained independent of age? some empirical evidence an empirical study of the fairness of allocation of health care resources the significance of age and duration of effect in social evaluation of health care measuring people's preferences regarding ageism in health: some methodological issues and some fresh evidence utilities versus rights to publicly provided goods: arguments and evidence from health care rationing ethical and distributive considerations measurement of health state utilities for economic appraisal the social value of a qaly: raising the bar or barring the raise? qalys and ethics: a health economist's perspective qaly maximisation and people's preferences: a methodological review of the literature consequentialism and its critics rights, goals, and fairness development as freedom personal utilities and public judgements: or, what's wrong with welfare economics rational normative economics vs 'social welfare' and 'social choice the social value of health programmes: is age a relevant factor? preferences for lives, injuries, and age: a stated preference survey are some lives more valuable? an ethical preferences approach maximizing health benefits versus egalitarianism: an australian survey of health issues preferences for life saving programs: how the public discounts time and age health priorities and public preferences: the relative importance of past health experience and future health prospects the nature of procedural preferences for health-care rationing decisions should health gains by children be given the same value as health gains by adults in an economic evaluation framework? in: economic evaluation in child health details omitted for double-blind reviewing details omitted for double-blind reviewing details omitted for double-blind reviewing details omitted for double-blind reviewing the generation gap: differences between children and adults pertinent to economic evaluations of health interventions are newborns morally different from older children? social policy for children and families: a risk and resilience perspective life course health development: an integrated framework for developing health, policy, and research towards a sociology of child health details omitted for double-blind reviewing details omitted for double-blind reviewing a review of conceptual approaches and empirical evidence on probability and nonprobability sample survey research a perspective on judgment and choice -mapping bounded rationality individual differences in reasoning: implications for the rationality debate? who is rational? studies of individual differences in reasoning intergenerational equity: an exploration of the 'fair innings' argument an equity framework for health technology assessments voices for children: rhetoric and public policy values and assumptions underpinning policy for children and young people in england an evaluation framework for funding drugs for rare diseases age-related preferences and age weighting health benefits eliciting preferences for prioritizing treatment of rare diseases: the role of opportunity costs and framing effects psychology and economics a better alterative to stratified permuted block design for subject randomization in clinical trials details omitted for double-blind reviewing a framework for rationing ventilators and critical care beds during the covid- pandemic fair allocation of scarce medical resources in the time of covid- details omitted for double-blind reviewing who should get what, and why? on deservingness criteria and the conditionality of solidarity among the public the deservingness heuristic and the politics of health care the political logic of labour market reforms and popular images of target groups public support for sanctioning older unemployed-a survey experiment in european countries the need for and the societal legitimacy of social investments in children and their families: critical reflections on the dutch case the role of welfare state principles and generosity in social policy programmes for public health: an international comparative study contemporary public policy influencing children and families  "when it comes to relieving suffering, other factors shouldn't count."  "we should always relieve pain when we can."we should rescue those at risk of dying  "everyone deserves the same chance of rescue from life-threatening circumstances."  "saving someone's life is important, regardless of age."treat those society considers special  "children are a distinctly valued social group that deserves privileged treatment."give priority to rare diseases  "rare diseases are often neglected, so should receive special priority."  "childhood disease are often rarer than adult ones, so might be unfairly overlooked in health system planning." key: cord- -wvu t authors: daly, bradford d.; gardner, rachel a. title: a case study exploration into the benefits of teaching self-care to school psychology graduate students date: - - journal: contemp sch psychol doi: . /s - - - sha: doc_id: cord_uid: wvu t it has long been established that school psychology practitioners experience high levels of burnout. as a means of preventing burnout among future practitioners, school psychology training programs are frequently encouraged to teach and model self-care to students. this is particularly important as the current generation of graduate students experience high levels of anxiety and depression, but there have been very few examples in the research literature of how training programs should teach self-care and whether it is actually effective. the current study presents results from an exploratory case study, which integrated self-care instruction into graduate school psychology curriculum with a small sample (n = ) of first-year school psychology students across two separate cohorts. students created written plans with self-care strategies that they attempted to implement over the course of their first semester in graduate school. a qualitative review of their plans and written reflections revealed that students described many sources of stress upon entry into training, and most needed to revise their strategies for coping as stresses changed during the semester. overall, student reflections revealed that the self-care activities were helpful to meet the demands of their graduate education. with the field of school psychology facing shortages in the near-and long-term future, the profession can ill afford to lose practitioners or prospective practitioners due to attrition. an estimated % of school psychologists leaves the field each year for reasons other than retirement (castillo et al. ), a number that in most regions of the usa exceed the projected number of new school psychology graduates entering the field each year. while the exact number and reasons that school psychologists leave the field are unclear, one potential reason that has been proposed is the high level of susceptibility of practitioners to burnout. research of school psychology practitioners (e.g., wilczenski ; kaplan and wishner ; mills and huebner ; huebner and mills ; worrell et al. ) has consistently found that while school psychologists have high levels of job satisfaction, they nevertheless also experience high levels of emotional exhaustion, feelings of depersonalization, and reduced sense of personal achievement, which unmitigated may result in burnout. newman ( ) proposed that unaddressed burnout can lead to problems with professional competence and engagement in ethically questionable practices. application of self-care strategies has frequently been recommended as a means of preventing burnout and increasing meaning derived from work. in fact, engaging in self-care has been described as an ethical imperative by multiple authors (lopez ; barnett and cooper ) . newman ( ) defined self-care behaviors as ones that are used to "establish and promote physical and emotional wellness, and to allay stress" (p. ); self-care behaviors serve to both mitigate stress and promote personal wellness, thereby ensuring the optimal quality of services provided by practitioners. selfcare has been conceptualized as a multi-dimensional construct, with some authors proposing four domains (newman) and others proposing six domains (butler et al. ) . common elements of self-care definitions include behaviors designed to promote physical wellness (e.g., physical exercise and nutrition), enhance cognition (e.g., professional development, supervision), promote emotional well-being (e.g., seeking counseling, communication), and deriving meaning from work (e.g., mindfulness practices, religious and spiritual practices). there is some correlational research regarding the effectiveness of self-care strategies on the functioning of mental health professionals. in a study of clinical psychologists, stevanovic and rupert ( ) found that psychologists who engaged in a greater number of self-care behaviors experienced greater job satisfaction. a survey of school psychologists (bolnik and brock ) found that % believed that engaging in self-care practices was important, and more frequent strategy use was associated with fewer physical symptoms of stress. coster and schwebel ( ) used a mixed methods approach to identify that % of psychologists had experienced personal impairment, and that effective strategies to address impairment included attending to personal relationships, going on vacations, striking a work-life balance, and developing self-awareness. in summary, this research evidence seems to provide at least some support for the importance of school psychologists engaging in self-care behaviors. based on these findings, researchers writing about self-care for psychologists frequently recommend that graduate programs directly teach self-care to prepare students to use self-care strategies in their future professional careers (newman ; huebner et al. ; barnett et al. ; barnett and cooper ), but there is very little empirical research to guide these recommendations. there are a small number of studies that have examined self-care strategy use by graduate students in mental health professions. myers et al. ( ) examined stress and self-care behaviors among clinical psychology graduate students and found that sleep hygiene, social support, and mindful awareness were related to lower stress levels. turner et al. ( ) , in a survey of school psychology interns, identified a number of strategies used by interns to manage stress including self-awareness activities, social activities, exerting control over professional activities, and appreciating intrinsic professional rewards, all of which were identified by the interns as being effective strategies. these studies provide some correlational evidence for the importance of self-care for graduate training, but the question of whether self-care behaviors can be successfully modified by training programs remains largely unexplored. several authors (lopez ; barton et al. ) have described various ways that school psychology training programs could integrate self-care into their curriculum, but there remains little evidence as to the effectiveness of these recommendations. lewis and king ( ) described efforts to integrate a self-care unit into social work students' field experiences, and provided qualitative evidence attesting to the benefits to students, providing a potential model for school psychology training programs to use. it is particularly important to consider the self-care needs of graduate students in school psychology given the overall context of high mental health needs among graduate students in general. a recent study (evans et al. ) found that graduate students both in the usa and internationally have six times the rate of depression and anxiety in comparison to the general population. there is some reason to believe that these rates may be higher in school psychology programs due to lower rates of financial support than other disciplines (proctor and truscott ) and the nature of school psychology training that involves intensive coursework and fieldwork (barton et al. ) . a study of training programs in school psychology (gadke et al. ) found that in the - academic year, one student withdrew from their training program for every . graduates at the specialist level and for every . graduates at the doctoral level. based on this information, it seems reasonable to consider school psychology graduate students a population that is vulnerable to stress and anxiety, yet vital to the future health of the school psychology profession. training programs need to develop a deep understanding of the sources of stress for graduate students in school psychology and a means by which to assist students in coping with these stressors. with self-care strategies having emerged as a promising practice in mitigating stress and burnout, training programs should seek to design ways to integrate self-care into their curriculum and monitor the effectiveness of doing so. an important question to consider when attempting to train students to apply self-care strategies is an understanding of the nature of self-care. much of the correlational research into self-care practices by mental health professionals has at times defined self-care as engagement in a number of coping behaviors at a specific point of time (e.g., stevanovic and rupert ; bolnik and brock ) . this research tradition suggests that self-care might be best conceptualized by considering the volume and diversity of coping skills employed by individuals. on the other hand, the im-paact framework (brown ) defines self-care as a more fluid concept, comprised of four stages: (a) prioritizing self-care, setting goals, incorporating into schedule, (b) implementing self-care plan and refine as necessary, (c) connecting internally and with an external social support network, and (d) thrive by fully engaging in the self-care plan and regularly re-assessing and adjusting the plan as necessary. these same core elements are consistent with the self-care plans developed, implemented, and revised by graduate students in the current study. moreover, drawing from the related literature on coping strategies for managing stress, coping skills have been theorized to fall within two distinct categories (i.e., problem-focused or emotion-focused; mcnamara ). using active problemsolving is an example of problem-focused coping. in general, such problem-focused coping is associated with better functioning and management of stress compared to emotionfocused coping. arguably, proactively planning for self-care in the midst of school-and work-related stress can be considered a form of problem-focused coping. the theoretical orientation is important because trainers interested in incorporating self-care into school psychology curriculum may make different decisions about how and what to cover based on an understanding of the construct of self-care. the present study was designed with two primary goals in mind. first, it is important for school psychology trainers to better understand the nature of the construct of self-care and how it can meet the needs of graduate student trainees. second, it is important to understand whether an intervention aimed at self-care could be effective as a means of addressing stress experienced by trainees in graduate school. therefore, this study was designed to provide an in depth understanding of the self-care practices of two cohorts of graduate students following a sustained semester-long intervention to integrate self-care into the school psychology training curriculum through a systematic case study inquiry. case study research has a long history in many disciplines, and is especially appropriate in circumstances in which an in-depth description of a case may inform future theory, research, and practice (creswell and poth ) . case study research is particularly useful in situations in which the primary research questions involve understanding the how and why behind a construct and intervention, especially when conducted over a period of time (yin ) . in this study, an analytic approach called explanation building (yin) was undertaken to provide a detailed examination of the experiences of the graduate students while experiencing a self-care intervention, intended to help other researchers and trainers conceptualize the fluid nature of self-care and whether an intervention based on the im-paact model could improve self-care practices among graduate students. two separate cohorts of graduate students across years (n = ) enrolled in their first semester at a school psychology training program participated in the present study. within each cohort, % of enrolled students participated in the self-care intervention in the present study and all completed the study through the three measurements. the school psychology program is a combined specialist level and doctoral level (psy.d.) program and is located in a small private university in the northeastern usa. in the present study, of the participants were members of the specialist program and the remaining were enrolled in the doctoral program. all students participated in the intervention described in the present study as part of the required coursework for their field experience seminar. per the university's committee on ethical research with human subjects, all participants were given the option to exclude the use of their anonymized data for this project. due to the small sample size in the present study, detailed demographics on the participants could not be reported due to the risk of revealing their individual identities; however, statistics on the overall graduate program during the time the study was implemented are available to convey information about the characteristics from the population that the participants derived. as reported by gadke et al. ( ) , approximately to % of school psychology graduate students nationwide are male, and approximately % are students of minority status. at the time of the study, the program overall had a percentage of students of minority status of %, which is lower than the national average cited above. the percentage of male students enrolled in the program overall was %, which is in line with the national average cited above. because of the very small number of male and ethnic minority students who were participants in this study, in all responses, identifying information was masked to prevent revealing identities. in some cases, participant responses were altered slightly to remove or change information that could be identifiable, in order to mask their identities. the two cohorts participating in the study were enrolled in consecutive academic years. the first cohort (n = ) was larger than the second cohort (n = ), but the group composition was overall similar. the large majority of students were in their early twenties and were enrolled in graduate school within a year of receiving their undergraduate degree; however, it is not possible to provide detailed age data due to risks to breaking participant confidentiality. per yin's ( ) recommendations, case study research can provide support for the external validity of their claims through replication of its procedures; therefore, having two separate cohorts complete the self-care intervention, while the overall number of participants is small, helps to strengthen the validity of the conclusions. the school psychology training program at which participants were located is housed within a college of graduate studies in counseling, psychology, and education. the school psychology's specialist program is approved by the national association of school psychologists and the psy.d. program is accredited by the american psychological association. at the time of data collection, there were full-time faculty with primary appointments to the school psychology program. the training program uses a cohort model with both specialist and doctoral students taking the same coursework in the first semester. students are required to take a total of credit hours in their first semester. the first semester within the training program emphasizes acquisition and maintenance of personal and professional skills. therefore, students take foundational coursework in learning and cognition, psychometrics, individual norm-referenced assessment, interpersonal communication skills, cultural awareness, and perspectives in school psychology. in addition to coursework, students in the training program are required to enroll in a school-based practicum experience day per week for a total of h in the first semester. finally, students also are assigned a graduate assistantship, which provides partial tuition remission in exchange for h of work per week. one unique characteristic of the training program is its location, which is in a rural community over an hour's drive away from major population centers. this provides students with experiences in rural schools and populations, but does make it more difficult for students who are working full time to commute. therefore, many of the students live in apartments in fairly close proximity to the university during the academic year. the primary author served as the instructor for the field experience course and the facilitator for the self-care intervention. in this role, there was the advantage of being embedded within the system and milieu along with participants, as well as the drawback of potential lessened objectivity from serving in an evaluative role to the participants. the instructor was a white male in his late thirties, and was in his first years as a fulltime core faculty within the school psychology training program over the course of the intervention. prior to joining the program faculty, the instructor had years of experience as a practicing school psychologist, and drew heavily on these experiences in describing the importance of self-care throughout the intervention. both cohorts participated in the self-care intervention in their first semester field experience seminar. the overall goal of the intervention was to help participants reach the thriving state of self-care based on the im-paact model (brown ) for application of self-care. the transactional model of coping emphasizes active application of coping in response to appraisals of stressful events (lazarus and folkman ) , and intervention in coping skills emphasizes application of problem-focused strategies and reducing use of avoidancefocused strategies (mcnamara ). the thriving state of self-care suggested by im-paact model predicts that this coping approach can be developed through promoting the prioritization of self-care, developing and evaluating a plan, and connecting internally to self-care and externally to others (brown ) . a summary of the steps of the self-care intervention designed to adapt the im-paact (brown ) framework is included in table for quick reference. during the first week's seminar, participants were prepared for their practicum experience through discussions about expectations and requirements. the first step of the self-care intervention, a didactic discussion led by the instructor, was embedded into this initial seminar. this discussion began with a short lecture about the effects of stress on professionals in school psychology, and the progression of unhealthy stress that can lead to burnout and problems of professional competence, based on the models of stress proposed by newman ( ) and mcnamara ( ) . participants were prompted to propose and share potential sources of stresses in their lives that could potentially lead to this unhealthy progression. the instructor then described that problematic stress could therefore lead to professionals engaging in ineffective and unethical practices. finally, the instructor introduced the notion that self-care strategies are posited to be a potential buffer against this negative progression. next, participants engaged in self-study with the goal of creating a plan with strategies that they could apply for selfcare. creation of a written plan to address stress through selfcare that is revised over a period of time is consistent with theoretical models of self-care (brown ) and parallels coping skill training as proposed by mcnamara ( ) . a series of readings and websites were provided to participants (see table for a list) to help them to generate ideas about how to structure and design a self-care plan. the participants were not given specific criteria for what format or content to include in their plans, but were advised to create plans that were multidimensional, individualized, specific, and realistic, so that the plan would reduce stress without adding new stress (newman ; lewis and king ) . participants submitted their self-care plans and a reflective writing piece to the instructor prior to the second week of class. these responses were used to facilitate a group discussion in the following seminar session. participants had the opportunity to share stressors and strategies they attempted to incorporate into the plans, which also helped to serve as member checks to ensure the credibility of the instructor's interpretations of their written responses. during this discussion period, the instructor primarily engaged in reflective listening while encouraging participants to think about ways that they could ensure the effective implementation of their plans. participants' self-care plans and written reflections were assigned a pass/fail grade based on completion of the requirements, which all participants did successfully. a brief written response was provided by the instructor to each participant, commenting on content in the student's reflective writing and encouraging their use of self-care strategies. the following is an example of one of these feedback comments: i'm glad to see the honesty in your response about feeling stressed. it's important to recognize when your stress level goes up and down so that you can react accordingly. don't be afraid to reach out to others, it's not a sign of weakness! good luck with following your self care plan this semester and managing your stress. discussion about implementing self-care strategies was embedded throughout seminars over the next several weeks, which was integrated with discussions about their professional work behaviors, and the nature of school psychology service delivery. while participants were encouraged to adjust their self-care routines throughout the semester, they were formally asked to revise and reflect on their self-care plans at two points. seven weeks into the semester (time ), participants were required to submit an updated self-care plan and written reflection in which participants were asked to reflect upon how well their plans worked, and to describe how they adjusted their plans to better meet their needs. the instructor used their responses in the following seminar session to again facilitate a group discussion about stress and self-care. finally, this process was repeated at the fourteenth week of the semester (time ) as a means for participants to have a summative examination of their self-care and stresses in their first semester of graduate school. as before, their responses were used to lead a debriefing session in the last field experience seminar session for participants to reflect on the role of self-care in their graduate education and to plan for the future. qualitative data used for the study included the student's selfcare plans and written reflections submitted as part of the coursework requirements at three measurements: time , time , and time . reflections and plans were both de-identified with student names and identifying characteristics removed from responses prior to analysis. as sources of data for this project, the written reflections were useful in understanding participants' cognitive appraisals of stressors and their coping responses, making them amenable to interpretation based on the transactional model of coping (lazarus and folkman ) . yin ( ) described tactics that can be used in case study research to support construct validity of conclusions. the first such tactic is through the use of multiple sources of information. while participant interviews and seminar discussions were not transcribed for separate analysis, they did provide external verification of the contents of the participants' written reflections, helping to support that they represent an accurate account of their experiences. a second tactic described by yin is establishing a clear chain of evidence for case study data. to analyze the written documents in this study, de-identified student reflections were initially downloaded from the online course management software. these raw responses were compiled into a single document in microsoft word. after compilation, participant responses were read by the primary author twice to identify excerpts of the response that could be relevant to understanding the responses of the participants based on the stages proposed by the im-paact model (brown ) . these excerpts were then extracted into a separate research database in microsoft excel, thus providing a clear chain of evidence for the qualitative data to be analyzed. once the participant response database was compiled, the analysis strategy for these data sources was developed based on recommendations for case study research by yin ( ) and creswell and poth ( ) . in general, a pattern matching approach was used to analyze the participant responses based on the im-paact model (brown ) and transactional model of coping (lazarus and folkman ; mcnamara ) . yin described pattern matching as a technique in case study research involving searching for patterns in the data predicted by theory or prior research. a subset of this approach, explanation building, is particularly useful when step brief description in the first field experience seminar, students were introduced to the idea of self-care as a means to avoid burnout. . guided self-study students were assigned to research self-care through a collection of articles and websites. specific readings assigned included: • self-care: the missing link in best practice -part i (lopez ) • self-care: the missing link in best practice -part ii (lopez ) • developing a self-care plan (reachout.com, n.d.) • best practices in early career school psychology transitions (silva et al. ) • self-care starter kit (butler and mcclain-meeder ) . self-care plan design students were required to design their own self-care plan and submit it to the instructor prior to the second week of the semester. at time ( week into the semester), time ( weeks), and time ( weeks), students completed written reflection about their sources of stress and how their self-care plan was working or was not working to help to manage these stressors. attempting to understand how and why observed outcomes occur, based on a prior theoretical model. this approach was selected as the major goals included understanding how participants appraised and planned self-care strategies to cope, how participants adjusted these plans over the course of the semester, and how the participants evaluated the intervention and plan as being effective in helping them meet the stressors experienced during graduate school. based on yin's ( ) recommendations, the analysis of the qualitative data followed an iterative process. the authors started the process with a conceptual model for stress and self-care, specifically the transactional model of coping (lazarus and folkman ; mcnamara ) and the im-paact framework (brown ). the analysis started at a broad level through an initial reading of all responses in the response database, followed by a closer reading at the element level within responses to examine for information that matched patterns predicted by theory and might yield the explanatory information needed to respond to the research questions. these responses were then developed into codes through which themes in responses could be identified, and as yin recommended, these initial themes were then compared to the prediction based on the theoretical models. finally, the explanations were again compared to the data, and the second cohort provided an opportunity to test these interpretive explanations with a new data source. responses were found to match patterns that were extracted into three major themes upon which the findings section is organized. several efforts were undertaken to ensure the validity of these analysis procedures. first, and very important as identified by yin ( ) , the authors considered several alterative and rival interpretations at multiple stages of the analysis process. as one example of such an explanation, the authors were aware that participants could experience stressful life events outside of graduate school which could influence their implementation and selection of self-care activities; to help guard against this threat, all responses were examined for information about outside stressors that could potentially have affected the individual participants. other rival explanations considered during the analysis phase are noted in the findings section. another strategy used to support the validity of the analysis was through triangulation of multiple information sources (creswell and poth ) . member checking to ensure credibility of the conclusions happened throughout the course of the semester through in-class discussions of the themes the instructor identified in participants' responses. the instructor also debriefed with the participants as a group following the submission of final grades to help make sure their responses would be similar in theme to the written products used for analysis in the present study. prolonged engagement with participants over the course of the academic semester helped the author to have a relationship that encouraged honest and candid responses, and is considered to be another good practice in qualitative research (creswell & poth) . the reliability and credibility of the explanations were supported in the research process through a memoing notetaking procedure to document contemporaneous process notes (creswell and poth ) . a replication of the intervention and data analysis of the study with two separate cohorts gave an opportunity for initial explanations developed after the first year to be checked with new data in the second year of the study, and provided additional support for the findings (yin ) . finally, while it must be noted that the primary author was the course instructor and therefore may have been prone to bias, being embedded with the participants over the course of a semester also helped to lend credibility to the analysis (creswell & poth) . the im-paact model (brown ) described the first stage of thriving with self-care to be prioritization of self-care. to support the prioritization of self-care, and participant development of problem-focused coping strategies (mcnamara ), the selfcare intervention began providing participants with didactics about self-care and stress, and requiring them to make an appraisal of their current stressors. a summary of stressors identified by participants at time is presented in table . as noted in the table, the majority of participants reported stress in relation to the rigors and difficulty of their graduate coursework, and their ability to stay organized and manage time to effectively meet these challenges. many of the participants described the origin of this stress being internal, as exemplified by the following response from a male graduate student in his early twenties: the biggest stressors in my life are largely internal. they're preconceived notions about what i should be doing, or what i should be able to do "on my own." they're also issues surrounding a consistent drive to "accomplish" as much as possible, to the detriment of my own health and well-being. by requiring participants to engage in this self-appraisal, the goal of the intervention was to help them prioritize self-care and develop plans to help them meet their needs, thus adopting a problem-focused coping strategy (mcnamara ) . per the im-paact model, "the goal at the prioritize stage is to identify a variety of activities that seem most likely to bring fulfillment and are realistic for the particular individual. consideration for personal interests and resources is key" (brown , p. ) . that said, the research literature in self-care gives little guidance as to how professionals should organize, plan, and implement self-care strategies. through an analysis of participants' self-care plans developed for time , it appears that the strategies that participants included in their initial plans largely mirrored the stressors they reported at the start of graduate school in primarily addressing academic and social-related sources of stress. all participants organized their strategies into several domains, which was recommended in some of the readings they completed as part of the assignment (e.g., butler and mcclain-meeder ) . a summary of the most common domains included by participants, and examples of strategies that they included under those domains, can be found in table . as noted, it appears that participants developed plans that were tailored to their individual needs based on their selfappraisal of stressors. all participants included strategies that were intended to support their ability to keep up with coursework and manage their time. all participants included a domain for physical health that initially included some kind of strategy related to physical activity or exercise, ranging from planning on visiting the gym days a week for exercise to going for a walk regularly. a large majority of participants (n = ; . %) included spending time with a significant other (defined in the study as spouse, partner, girlfriend, boyfriend, fiancé) as part of their self-care plan. consistent with previous research with self-care (lewis and king ), the majority of participants (n = , . %) included a spiritual health domain, which included a large number (n = ; . %) who indicated that religious expression, including prayer or attending religious observances, was an important part of their self-care. as noted, it was important to the study's analytic procedures to search for information that did not fit predicted patterns. to mitigate the effects of a history threat on interpretations, the authors considered it important to note when participants described unusual discrete events that could impact their stress and coping response. three participants did report outside events which were coded to be in this category, for example, the death of a loved one and a serious health issue. responses for these participants were flagged and efforts were made to analyze their descriptions of stressors and coping separately, so as to avoid drawing conclusions about the idiosyncratic responses to these events. it is important, however, for trainers to note the potential impact of similar events on the stress and coping of graduate trainees. finally, one theme present in the responses of social work trainees in previous self-care research (lewis and king ) was that of compassion fatigue and secondary trauma due to stressful situations at their field placement. while these themes were expected in the present study, they did not feature in participant responses outside of two participants. the authors interpreted this finding as being related to the typical activities at the field placements in the first semester of the training program, which primarily involve shadowing, observing, and assessment, as opposed to providing mental health counseling. the intervention procedures included several features which were designed to support participants' implementation of selfcare strategies, assess their plan, connect with self-care both internally and externally, and adjust their plans accordingly. these included the cycles of reflections and revisions at time and time and the group discussions about self-care in the seminar. the im-paact model (brown ) predicts that these processes are important to successful application of selfcare in response to constantly shifting sources of stress. participants were asked at time and time to re-evaluate their sources of stress to provide an insight into their shifting appraisals of stress. the most prominent theme in participant responses regarding the evolution of their stresses was the need to find a balance between academic demands and other activities. there was a wide variance of responses to how participants evaluated their success at finding this balance at time and time , with participants describing the semester overall as causing very little stress and some conveying that they experienced extreme stressors. consistent with other work on self-care that has followed individuals over a length of time (e.g., lewis and king ), self-care practices for participants in this study evolved over the course of the semester in response to their shifting appraisals of stress, with participants experiencing some successes and challenges implementing strategies that they initially thought would be successful. all participants made adjustments to their plans at time , and all but two made further adjustments at time . a summary of the most common adjustments to plans can be found in table . as noted, most participants experienced difficulties in time management as a primary barrier for regular application of self-care strategies. many participants reported that they initially under-estimated the time that coursework, practica, and other responsibilities related to graduate school would take. one student, who had written at the start of the semester that graduate school had already threatened to become overwhelming, commented at the end of the semester, "i quickly realized that those stressors from undergrad and the ways i would cope with them, were not going to help this year." as noted in table , there were some participants for whom the cycle of revision and reflection on self-care plans provided impetus to seek out counseling support. all of these participants described the change as being very positive; for example, one female graduate student in her early twenties wrote on the benefits of seeking counseling: "i am so glad i started following this assignment because i have never felt so mentally healthy and fit in my entire life. i feel like a whole new person this semester because i am prioritizing my mental and physical health." one domain of self-care that participants found particularly difficult to implement was in the area of spiritual health. onethird of participants who originally included strategies regarding religious expression removed these strategies when revising their plan. this finding was an interesting difference from results reported in other research (lewis and king ), but overall is consistent with the im-paact model in terms of participants developing a plan that is adapted to their needs. theme : participants perceived that the intervention procedures supported their thriving with self-care brown ( ) proposed that the final stage in the implementation of self-care based on the im-paact model is characterized by thriving. reaching this stage does not mean that a professional's self-care plan is a finished product, but rather that the professional has fully engaged in a plan for self-care which is continually re-assessed and adjusted to meet changing needs. individuals at the thriving stage will have prioritized their wellbeing as a fundamental aspect of their professional effectiveness. in the present study, evidence that participants were in the thriving stage was evaluated through how they described their reactions to their self-care plan and their descriptions of their approach to self-care as part of their professional functioning following the semester-long intervention. importantly, a participant who is thriving could still struggle with implementing certain aspects of her plan, as long as self-care was clearly described as a priority and she provided evidence of committing to a continual cycle of assessment and adjustment of a self-care plan. based on the model, all participants in the study were characterized as being at least partially in the thriving stage of self-care at the end of the intervention. due to the richness of their responses, excerpts from three student reflections are presented below, which represented the continuum of responses to these questions (yin ) . the first such response, from a female participant, demonstrated the importance, predicted by the im-paact model (brown ) , of prioritizing self-care, and adjusting self-care behaviors to provide a balance of thriving in a way that enhanced productivity. the participant also described a commitment to continuing these practices in her graduate school and professional career, an important mark of thriving: overall, i think that having a self-care plan has been helpful this semester. if i had not thought about doing activities that i enjoy or that help me to relax, i think my only focus would have been school work. i am glad that through this assignment i was able to be reminded about the importance of taking time for myself and doing activities that i enjoy. i also think that while implementing my self-care plan took time away from completing school work, having that break made me more productive once i started school work again. i think that continuing to implement my self-care plan will be helpful as i continue through graduate school and begin working as a school psychologist. the second illustrative excerpt, from a male participant, exemplified how participants described the role of self-care as fundamental to their future professional functioning: i imagine that any professional career i choose will come with assorted ethical dilemmas and stressinducing deadlines. such troubles must not only be met with adequate clinical expertise, but an effective self-care regimen. i imagine that as i become more familiar with the program, and how best to formulate a self-care plan, i will be extremely prepared for these situations… my experiences will self-care throughout this semester, and the forthcoming, will be influential while rival explanations were actively considered in making interpretations of thriving in participant responses, such as whether some outside influence rather than the intervention procedures might have led participants to make these statements, it is important to point out that the design of the research made it impossible to rule out some alternate explanations for the results. one example is that of a maturation threat; in other words, that the experiences of the participants could simply be explained by normal changes that would have occurred over the first semester in graduate school even in absence of any intervention related to self-care. while some participants described outside stressful events or mitigating factors in implementation of their plans, all nevertheless attributed their commitment to self-care at least in part to the semester-long intervention. despite the focus in the field of school psychology in attracting and retaining professionals to meet the personnel shortage, and the long-recognized risks of burnout in the profession (e.g., huebner & mills, ) , there is little research on the application of self-care strategies as a means to prevent burnout and attrition. this is especially important for training programs, who obviously play a large role in developing new school psychology professionals to address personnel shortages. while there are many scholars (e.g., newman ; huebner et al. ; barnett et al. ; barnett and cooper ) who have recommended that training programs include self-care in their curriculum, most of the existing research into self-care is correlational, and therefore, it is unknown how training programs should best accomplish this among many other priorities, and whether interventions to teach self-care are effective. the present study attempted to address this shortage in the literature by developing an intervention for self-care that was implemented over the course of the semester and documenting outcomes of the intervention. as a case study example of a self-care intervention, this study is intended to guide the development of future research, as a proof of concept that a selfcare intervention developed based on the im-paact model and the transactional model of coping (lazarus and folkman ; mcnamara ) can be feasibly integrated into school psychology training. all participants who participated in this self-care intervention considered the creation of a self-care plan in the context of their field experience class, with check-ins to monitor and adjust the plan, to be a helpful exercise. several participants were quite enthusiastic, reporting that the stressors they experienced in graduate school were much more intense than anticipated. consistent with research documenting high levels of stress and anxiety among graduate students (evans et al. ) , participants in the present study described many and varied stressors at the start of their graduate education. the largest source of stress was graduate training itself, with students worrying about being able to manage the volume and difficulty of the material. students also frequently expressed anxiety regarding managing their personal and family relationships amid the demands on their time caused by coursework. students participating in this study designed self-care plans that appeared to be geared to meet the stresses they anticipated; however, many of the students found their initial plans to be inadequate to meet the demands of the training program. the im-paact model (brown ) described application of selfcare to be a process that best results in a plan that is individualized, continually assessed, and adjusted to changing stressors. previous research with self-care for students in mental health training programs (lewis and king ) also documented that self-care strategies for students evolved over the course of the semester and needed to be monitored and revised to be effective. there was evidence that the intervention procedures helped to support these behaviors among participants; future research should further explore the process of adopting and sustaining self-care behaviors, to inform efforts at instructing students and practitioners to engage in these behaviors. while the present study described a case study which should suggest several important hypotheses for future research to consider, there are some important limitations in the design of the study that must be taken into account in interpreting the results. first, the study's goal was to obtain an in-depth understanding of the stresses that school psychology trainees face and the strategies they use to cope with those stressors after a self-care intervention. as a result, the participants were all enrolled in a single graduate program, and were overall a more homogenous group in comparison to school psychology graduate students overall. this may be particularly important if considering applying the conclusions of this study to students who are members of a minority group. proctor and truscott ( ) for example found that themes of fitting in with other cohort members as being a paramount concern to students of minority status, but in the present study among largely white european american students this theme was much less prominent. future research should therefore consider using a larger and more heterogeneous sample to understand how the study's conclusions might extrapolate to students of minority status. the second important limitation was the lack of a comparison group to determine whether any described findings are causally related to the self-care intervention. without a control group, the design of this case study was such that it could not rule out whether, for example, the experiences described by students might simply represent normal maturation in response to starting a graduate program. finally, an important limitation for the present study was in nature of the measures used for data collection and analysis. while efforts were taken to ensure the dependability and credibility of the data and conclusions, students were submitting the artifacts for a grade in their course, and may have been incentivized to exaggerate the importance or value of the self-care plan. likewise, there were no external measures to estimate how often students were actually implementing strategies as they described in their reflections, nor any quantitative measures of stress and burnout. despite these limitations, the present study should provide researchers with a proof of concept model for embedding selfcare into school psychology training. given the research into graduate student mental health (e.g., evans, ) and especially when considering the covid- pandemic, for which there have already been documented negative effects on mental health in general (gao et al. ) , it is important to consider the mental health needs of students enrolled in school psychology training programs. furthermore, it is an important professional outcome of training for students to develop coping mechanisms while in training. it is vital for future research to extend the understanding of the construct of self-care and explore interventions that can help inform practice and training recommendations. creating a culture of self-care in pursuit of wellness: the self-care imperative incorporating selfcare into your graduate school career the self-reported effects of crisis intervention work on school psychologists hazards of our helping profession: a practical self-care model for community practice self-care starter kit six domains of self-care: attending to the whole person personnel needs in school psychology: a -year follow-up study on predicted personnel shortages well-functioning in professional psychologists qualitative inquiry and research design: choosing among five approaches ( th) evidence for a mental health crisis in graduate education nasp report of graduate education in school psychology mental health problems and social media exposure during covid- outbreak burnout in school psychology: the contribution of personality characteristics and role expectation best practices in managing stress and burnout school psychology trainers' identification of current stressors in the work lives of urban practitioners. a comparison study stress, appraisal, and coping teaching self-care: the utilization of self-care in social work practicum to prevent compassion fatigue, burnout, and vicarious trauma self-care: the missing link in best practice -part i self-care: the missing link in best practice -part ii stress in young people: what's new and what can we do a prospective study of personality characteristics, occupational stressors, and burnout among school psychology practitioners self-care practices and perceived stress levels among psychology graduate students the school psychology internship: a guide for interns and supervisors reasons for african american student attrition from school psychology programs developing a self-care plan best practices in early career school psychology transitions career-sustaining behaviors, satisfactions, and stresses of professional psychologists intern self-care: an exploratory study into strategy use and effectiveness marking the school psychology lifespan: entry into and exit from the profession school psychologists' job satisfaction: a -year perspective in the usa case study research and applications acknowledgments the authors would like to thank jennifer daly and nicholas sanders for assistance with copyediting and manuscript preparation.data availability the datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request. conflict of interest the authors declare that they have no conflict of interest.ethics approval the research reported in this manuscript was classified as exempt by the institutional review board at a small, northeastern private university. publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.dr. bradford daly is an assistant professor and program director in the school psychology program at alfred university. he has years of experience as a practicing school psychologist and continues to consult in public schools. he is interested in applications of positive psychology and professional issues of school psychologists, particularly at the secondary school level. recently he has contributed to a project involving the effects of social media on the wellbeing teenagers.dr. rachel gardner is an assistant professor of school psychology at alfred university. her primary professional interests include tiered school-based mental health services and promoting student' subjective well-being. her research interests include the impact of social media usage on adolescents' wellbeing, provision of evidence-based mental health services within an mtss framework, and positive psychology interventions applied to youth in school settings. key: cord- - r authors: uscher-pines, lori; schwartz, heather l.; ahmed, faruque; zheteyeva, yenlik; tamargo leschitz, jennifer; pillemer, francesca; faherty, laura; uzicanin, amra title: feasibility of social distancing practices in us schools to reduce influenza transmission during a pandemic date: - - journal: j public health manag pract doi: . /phh. sha: doc_id: cord_uid: r schools are socially dense environments, and school-based outbreaks often predate and fuel community-wide transmission of seasonal and pandemic influenza. while preemptive school closures can effectively reduce influenza transmission, they are disruptive and currently recommended only for pandemics. we assessed the feasibility of implementing other social distancing practices in k- schools as a first step in seeking an alternative to preemptive school closures. methods: we conducted focus groups with education and public health officials across the united states. we identified and characterized themes and compared feasibility of practices by primary versus secondary school and region of the united states. results: participants discussed school practices ( within-school practices implemented as part of the school day and reduced-schedule practices that impact school hours). participants reported that elementary schools commonly implement several within-school practices as part of routine operations such as homeroom stay, restriction of hall movement, and staggering of recess times. because of routine implementation and limited use of individualized schedules within elementary schools, within-school practices were generally felt to be more feasible for elementary schools than secondary schools. of reduced-schedule practices, shortening the school week and the school day was considered the most feasible; however, reduced-schedule practices were generally perceived to be less feasible than within-school practices for all grade levels. conclusions: our findings suggest that schools have many options to increase social distance other than closing. future research should evaluate which of these seemingly feasible practices are effective in reducing influenza transmission in schools and surrounding communities. they may also recommend other social distancing measures in other community congregate settings (eg, workplaces, mass gatherings) to slow the spread of disease and thereby relieve pressure on overburdened health care and public health systems. [ ] [ ] [ ] schools are important settings for social distancing. because public schools are socially dense environments where more than million students congregate across the united states each day, schools can fuel community-wide disease transmission. [ ] [ ] [ ] in addition to promoting respiratory etiquette and hand hygiene and engaging in frequent environmental cleaning, schools can implement practices that promote social distancing to potentially protect large numbers of vulnerable children, as well as limit secondary transmission to adults within their households and communities. over the past decade, research and guidance on social distancing in us schools have mainly focused on school closure as the most impactful, albeit disruptive, social distancing practice. while a substantive evidence base documents that school closure can mitigate influenza pandemics, there may be potentially less disruptive opportunities to increase social distance among students who remain in school. [ ] [ ] [ ] nonetheless, feasibility, acceptability, and effectiveness of the full range of school social distancing practices have not been explored. [ ] [ ] [ ] to address this gap, the us centers for disease control and prevention and rand health conducted a large qualitative field study to examine the feasibility of social distancing practices other than school closures in k- schools. through focus groups with senior education administrators across the united states, we aimed to identify potential social distancing practices beyond school closure, describe barriers to and facilitators of implementing these practices for at least weeks to decrease the spread of influenza before many students become ill, and rank practices by feasibility. in the summer of , we conducted focus groups with education and public health officials via webinar. participants were selected from all us department of health & human services (hhs) regions to explore perspectives that might differ by region of the country. we also recruited participants representing both primary and secondary schools to compare how barriers and facilitators might vary by grade level. we recruited superintendents, principals, teachers, school nurses, state school nurse consultants, district transportation directors, state health pandemic planners, and school safety representatives. for each hhs region, we assembled a purposive sample of participants by searching professional association web sites and lexisnexis and conducting snowball sampling with focus group attendees. within professional association web sites, we searched for lists of members, conference attendees, and association leaders. in lexisnexis, we looked for names of school leaders who were quoted in the media about emergency preparedness. a total of participants, representing all regions, participated in a total of focus groups. the number of participants per focus group ranged from to , with a mean of . each participant participated in a single focus group. a team of moderators trained in qualitative research conducted the focus groups via webinar. most of the groups consisted of participants from a single hhs region, but groups included a mix of several hhs regions to accommodate scheduling preferences. participants were contacted via e-mail and offered a $ gift card as an incentive. all focus group discussions were recorded and then transcribed. each group followed a semistructured protocol, and participants were asked to identify, mention experience with, and discuss the feasibility of practices within of categories: practices that could be implemented within a normal school schedule ("within-school practices") and those that would require an altered school schedule ("reduced-schedule practices"). to limit focus group duration to minutes, groups discussed within-school practices ( focused on elementary schools, focused on secondary schools, and discussed both elementary and secondary schools) and discussed reducedschedule practices (both elementary and secondary schools). in each group, participants were first presented with a list of practices assembled by the study team and asked to brainstorm any additional practices that could be implemented in k- schools. second, they discussed any direct experiences with listed practices as well as implementation barriers and facilitators of each individual practice. finally, they selected the most and least feasible practices from among the full list of practices. feasibility was defined as "ease of implementation" in this context. this study was approved by rand's institutional review board, and all participants gave oral consent to participate at the start of each focus group. standard qualitative analysis techniques were used to identify and characterize instances of themes arising from the various topics covered in focus group protocols (eg, each identified practice) as well any unanticipated themes that emerged. two of the authors read each transcript and independently coded. to ensure that different coders were interpreting the data as similarly as possible, we ( ) developed descriptive and precise codebooks that gave each code a clear definition and meaning; ( ) performed intercoder agreement checks prior to analyses where all analysts read the same text, coded independently, and discussed areas of disagreement; and ( ) performed supervisory reviews of the analysis at regular intervals. we compared themes by hhs region as well as by secondary versus elementary school settings, and we reported any differences identified. dedoose qualitative research software was used to facilitate data handling, coding, and thematic analyses. for ranking, participants in within-school practices focus groups could vote for practices they perceived as the most feasible and perceived as the least feasible. for the focus groups on reduced-schedule practices, participants voted for the single most feasible and single least feasible practice. individual votes were summed. we first present the full menu of social distancing practices (other than school closure) discussed by focus group participants as well as high-level summaries of perceived barriers, facilitators, and variation by region and/or grade level. we then present details on the barriers and facilitators for the within-school and reduced-schedule practices that ( ) were deemed most feasible by participants and ( ) could be implemented continuously over at least weeks. participants discussed a total of school practices ( within-school practices and reduced-schedule practices). while practices were identified by the study team in advance through policy and literature reviews, additional within-school practices were identified by focus group participants. additional practices included limiting group work, limiting congregation at arrival and dismissal, encouraging solo physical activity, canceling cross-school transfer for special programs such as dual enrollment, reducing congestion in the school health office, and educating students and family members to maintain their distance. practices with which participants reported prior experience as part of routine operations or in response to the h n pandemic are shown in table . for elementary schools, the more common within-school practices that some schools use as part of routine operations included homeroom stay, restricting hall movement (walking single file, a foot apart), segregating recess area by class, staggering recess times, segregating the cafeteria by class, and staggering lunch periods. common within-school practices implemented for the first time in response to the h n influenza pandemic included canceling field trips, canceling assemblies, limiting visitors, and reducing congestion in the health office. several participants also reported experience with reduced-schedule practices as part of routine operations and in response to emergencies, including operating on a -day week because of budget constraints, and shortening the school day (delayed start or early dismissal for severe weather). the perceived barriers and facilitators for each practice, as well as variability by grade level, are shown in table . within-school practices were generally perceived to be less feasible for secondary schools than elementary schools for a variety of reasons (eg, lack of homeroom; individualized and complex class schedules, including off-campus education activities; classes have students from multiple grades; need to use lockers to retrieve textbooks and other belongings). reduced-schedule practices, such as shortening the school week or the school day, were perceived to be less feasible than withinschool practices in both elementary and secondary schools because of complexities related to scheduling, transportation, staff work hours, communication to families, food preparation and provision, and a variety of regulatory issues (eg, required in-person instructional hours, union rules requiring duty-free periods for teachers) listed in table . the need to arrange childcare was especially challenging for the parents of elementary school students. as shown in tables and , the within-school practices most frequently perceived as feasible in both primary and secondary settings included canceling field trips ( votes), canceling assemblies ( votes), rearranging desks to increase space between students in the classroom ( votes), restricting hall movement (elementary only) ( votes), and limiting nonessential staff and visitors ( votes). the practices most frequently identified as least feasible included moving class outdoors ( votes), staggering class start and dismissal times ( votes), separating classes into smaller groups ( votes), and shortening and staggering lunch times ( votes). the reduced-schedule practice considered the most feasible was a shortened school week affecting the entire school ( votes), and the least feasible was selective dismissal of one class or one grade in a school ( votes). we did not identify keeping one cohort of students together throughout the day is the norm in many elementary schools, though students often leave the classroom for specialty classes such as physical education, music, art. rearrange desks to increase space schools experiment with a range of seating configurations depending on grade level, students' needs, subject area, and available space and furniture. one participant discussed experience with this practice during the h n pandemic, noting that he configured students' seats so that they were no longer facing each other in a pod formation. hallway and bathroom practices restrict hall movement several participants stated walking single file, about a foot or an arm's length apart, is common in elementary schools and leads to orderly transitions between classes. it has also been used successfully during fire drills. limit bathroom use to reduce congestion in the bathroom bathroom use is highly grade level-specific. elementary school students are more likely to have common bathroom breaks when students use the bathroom in groups, while middle and high school students typically use bathroom passes. limit congestion during arrival and dismissal several participants reported limiting congestion by requiring students to report directly to their first class upon arrival and to remain in their last class until just before departing the campus. stagger class start and dismissal times to reduce load in hall a few participants reported experience with staggering the start and end time of the school day, and with staggering the class start and end times throughout the day without changing the overall length of the day (mainly for schoolwide activities such as assemblies). for instance, a participant reported modifying class start and dismissal times to separate the grades, reduce congestion in the halls, and protect the smaller and younger students. schoolyard and recess practices segregate recess area by class some elementary schools segregate the recess area by class (eg, one class is on the field and one is using the playground equipment). it is also common in smaller schools for each class to have its own time slot in the recess area. shortening the school day several participants described experience with this practice, often due to severe weather ( -or -h delay or early dismissal), or for professional development activities for staff. dismissal of one grade several participants described having used this practice, such as dismissing an entire grade for a field trip or for testing purposes. none any substantive variation in perceived feasibility by us region; however, moving class outdoors was considered more feasible in locations with mild climates. moving desks at least -ft apart to increase the physical distance between students is a social distancing measure that could be implemented in some classrooms. one participant discussed experience with this practice during the h n pandemic, noting that he configured students' seats so that they were no longer facing each other in a pod formation and indicated that this required some substantial "geometry." barriers to this practice did not vary by location in the united states; however, there was variation by grade level because different types of seating arrangements are used for different ages. barriers to implementing this practice included insufficient classroom space to spread desks out, inflexible seating arrangements and furniture, and negative impacts on students with special needs (eg, those who need to be located in the front row during instruction). participants indicated that flexible seating arrangements, such as desks and chairs that can be moved separately, would facilitate reconfiguring a classroom to create additional space between students during a pandemic. also, a region participant discussed how schools with limited space could rearrange students (eg, have all students face front, limiting face-to-face contact) without necessarily rearranging furniture. finally, a region participant discussed encouraging elementary-age students to fully utilize all the spaces in the classroom (eg, rug on the floor, rocking chair) rather than be limited to using desks and chairs at all times. he explained, they like gathering in a carpet area or … like a rocker or pillows. so, when they're doing their work, they can move around the room and find a different spot that's not at their table, and so that's a little bit more of a common practice at the elementary level. with a shortened school week, students do not attend days in a row. this practice can apply to required instructional time states typically require a minimum number of instructional hours or school days as a condition for funding. if these requirements are not met, schools, or particular classes, must make up missed time by meeting on holidays or weekends or extending the school day. required physical activity (including recess and physical education) participants discussed some legal and regulatory challenges in decreasing or eliminating recess time or physical education class as part of a within-school practice or as a result of reduced-schedule practices, including the fact that some communities have requirements about the number of physical activity minutes students must receive. required duty-free or planning time for staff participants cautioned against asking teachers or other staff to supervise students at times that were previously designated as "duty-free" or reserved as planning periods. to extend duty hours, schools would either need to hire substitutes to supervise students or ask existing staff to assume the extra responsibilities, in some cases violating union terms. required time for certification a variety of practices can harm students' ability to earn credit or fulfill requirements for certification. for example, certain career and technical programs require students to complete a certain number of hours to meet the criteria for certification. legal obligation to adhere to individualized education plans (iep) a number of practices (eg, movement restriction in class, cancellation of cross-school transfer, reducing school hours) can conflict with the ieps of special needs students. federal law obliges schools to adhere to ieps. mandated standardized testing a number of practices (eg, shut down computer lab, reduce school hours) can interfere with students' preparation for or the actual delivery of mandated standardized testing. many communities require that teachers have certain qualifications (eg, be certified, pass a background check) as a condition of employment. such requirements can be barriers to hiring additional staff in an emergency. the entire school (eg, all students attend monday through wednesday only), or the school can alternate so that some students, for example, attend monday and tuesday and the others attend thursday and friday. several focus group participants noted that their districts were already operating on a -day week because of budget constraints. the leading barriers to implementation of this practice include burden on parents to find childcare, impact on students who rely on schools for meals, need to make up missed instructional hours, challenging communication with parents about complex school schedules especially with alternating days, lower educational quality, and burden on staff. these barriers did not vary significantly by region of the country or grade level, with the exception of childcare needs being more pronounced for elementary-aged children. participants identified several facilitators to this practice. many felt that a shortened school week would be less of a burden than shortened days on parents and on the bus transportation system because the disruption would be limited to to days per week rather than all school days. participants recommended having the whole district or at least all schools within the same feeder cluster operate on the same schedule to reduce some of the complexities for families with multiple children. factors that could increase the feasibility of this practice include giving parents plenty of advance notice, engaging key stake-holders to explain why and how the new schedule will work, obtaining a waiver from the state so that district funding is not reduced, putting a distance learning plan in place to continue instruction when students are at home, and offering meal programs off the campus for students not attending school on a given day. through focus groups in all hhs regions, we identified and reviewed social distancing practices that schools could implement in an influenza pandemic while continuing to operate. participants reported prior experience with several within-school practices in elementary schools as a part of routine (nonemergency) operations. these practices included homeroom stay, restriction of hall movement, segregation of recess area by class, staggering of recess times, segregation of cafeteria by class, and staggering of lunch periods. within-school practices were generally perceived to be more feasible for elementary schools than secondary schools. reduced-schedule practices, such as shortening the school week or the school day, were perceived to be less feasible than within-school practices in both settings. the practices considered the most feasible were those that involved isolated events like field trips and all-school assemblies or furniture rearrangement that had little to no staffing, curricular, or cost table ). c considered feasible for elementary schools only. implications. in general, the practices considered the least feasible were those that required smaller classes, more staff, more square footage, or staggered start and end times. these were considered less feasible because they require hiring more staff on short notice, rewriting lesson plans, altering parent work schedules on a daily and prolonged basis, or finding more space in already crowded buildings. within-school practices that do not change the academic calendar in any way are easier to implement than reduced-schedule practices. in addition, reduced-schedule practices that affect the entire school rather than subgroups of students are easier to implement because an alternating schedule presents additional challenges (eg, need for additional bus routes, extra burden on parents with students on different schedules, and need to explain complex scheduling with clear, consistent messages). state and district policies on required instructional time, required physical activity hours, duty-free periods for teachers, professional development hours for teachers, and/or teacher qualifications were frequently mentioned as key barriers to making significant changes to school schedules and supervision of students. schools can surmount some of these regulatory legal and regulatory barriers by seeking waivers and building flexibility into staff contracts. our findings indicate that several within-school practices could be implemented in elementary schools to reduce the transmission of influenza (eg, keeping students in their homerooms for the entire school day, restricting hall movement, segregating recess area by class, staggering recess times, segregating the cafeteria by class, staggering lunch periods). these practices might be more effective in reducing disease transmission across classrooms than within a classroom. practices such as canceling assemblies or field trips might be feasible but might not have a sustained impact on disease transmission because they are onetime events rather than practices that alter the nature of social interactions at school. implementation of some practices, such as rearranging desks to increase space, might be feasible but might not keep students from mixing, as it would be difficult to limit students' movement in class (eg, require students to stay seated at all times). students are likely to continue moving within the room and interacting with their peers. among the reduced-schedule practices, shortening the school week for the entire school was perceived as the most feasible. shortening the school week might be an alternative to prolonged school closure. to our knowledge, our study represents the first one to comprehensively assess the feasibility of social distancing practices in schools. this study builds on our previous review of the literature, which found that neither the peer-reviewed and gray literature nor the pandemic influenza guidance and plans included details on the range of potential practices or on the barriers schools would likely encounter in implementing social distancing practices. therefore, public health and school leaders had limited evidence to inform decisions about social distancing in schools. our previous literature review identified epidemiological and modeling studies that assessed the effect of selected school practices on reducing influenza transmission. in addition to school closures, these studies considered limiting use of congregation spaces such as the cafeteria as well as a number of social distancing practices that our study identified as infeasible (eg, class and grade dismissal, classroom movement restrictions, and staggered classroom schedules). an additional modeling study reported that shortening school week may be effective in reducing virus transmission. hence, further epidemiologic and modeling efforts are needed to explore the range of effects of social distancing practices that our study identified as feasible according to educators. this study has a number of limitations. first, we did not include parents because we chose to focus on educators' implementation challenges in school settings. while parents are crucial to ensuring compliance, they do not make the decision to implement social distancing measures and are not tasked with enforcing them in schools. nonetheless, many focus group participants are also parents or report to them, and they commented on how practices would be received by parents. second, although we engaged numerous stakeholders and achieved thematic saturation, findings represent the perspectives of focus group participants and might not be generalizable. third, we focused on the united states and did not engage school leaders from other countries, nor assess the implications of this work for an international audience. future research should explore the feasibility of school social distancing practices in a wide range of developed and developing countries. fourth, due to time constraints, some focus groups discussed within-school practices and others discussed reducedschedule practices. fifth, we explored perceptions of feasibility. more research is needed on the effectiveness of identified practices on reducing disease ■ schools and public health officials can jointly consider multiple practices to reduce influenza transmission during a pandemic as an alternative to closing. ■ these practices can also be considered in other outbreaks of infectious disease that affect school settings. ■ practices vary with respect to feasibility, with practices that can be implemented as part of the school day (vs those that affect school hours) considered the most feasible. transmission. before such evaluations are completed, infectious disease transmission experts can consider our data to determine which of the top-rated practices may be helpful in reducing school-based transmission of the disease(s) of interest. the study's strengths included the following: the study was based on a large number of focus groups, included participants from all hhs regions, and assessed feasibility by primary versus secondary school. in summary, our findings suggest that schools have options to increase social distance during an influenza pandemic or other infectious disease outbreak as alternatives to closing. given that influenza pandemics occur in waves and can last for months, it is critical to identify and consider alternatives to extended school closure, which is burdensome to students, parents, and employers. future research should evaluate the effects and optimal timing and duration of a set of seemingly feasible practices on influenza transmission in schools, given that selecting effective social distancing practices is the ultimate goal of policy makers and practitioners. in addition, feasibility and acceptability of the most promising practices will eventually need to be evaluated among other audiences, including parents and students. community mitigation guidelines to prevent pandemic influenza-united states the effects of school closures on influenza outbreaks and pandemics: systematic review of simulation studies school closures and influenza: systematic review of epidemiological studies evidence compendium and advice on social distancing and other related measures for response to an influenza pandemic school opening dates predict pandemic influenza a(h n ) outbreaks in the united states spatial transmission of pandemic influenza in the us emergency preparedness and response: school dismissals to reduce transmission of pandemic influenza school practices to promote social distancing in k- schools: review of influenza pandemic policies and practices weekends as social distancing and their effect on the spread of influenza key: cord- -m utrn g authors: madhusudhan, divya k.; thokala, sujith; hagg, heather k.; schoeneck, allison r.; pizzarello, daniel; bravata, dena m. title: an employer-sponsored musculoskeletal care coordination service can improve clinical outcomes and self-reported productivity date: - - journal: j occup environ med doi: . /jom. sha: doc_id: cord_uid: m utrn g objective: to evaluate the effects of participation with a novel musculoskeletal care coordination service on clinical outcomes, self-reported productivity, and satisfaction. methods: prospective analysis of participants using the service from january , to december , . results: one hundred eighty nine participants were enrolled; participants completed their recommended clinical pathway. low back pain was the most common musculoskeletal issue (n = , %). participants ( %) were triaged to home exercise and ( %) to physical therapy. behavioral health issues were common: participants ( %) were referred to their eap. only participants ( %) required a medical referral. engagement was associated with improvements in pain, physical function, mood, and self-reported productivity (p < . ). the net promotor score for this service was . conclusions: employers with populations for whom musculoskeletal complaints are common might benefit from integrating a musculoskeletal care coordination service in their benefits offering. etal complaints-one of the most common reasons for outpatient visits. , the direct costs associated with musculoskeletal conditions are among the highest in healthcare with costs for low back pain alone accounting for $ b annually. given that musculoskeletal pain is the second leading cause of workplace absenteeism resulting in approximately million lost workdays annually, employers bear a large share of costs associated with musculoskeletal conditions. thus, employers are increasingly seeking solutions that provide their employees with rapid access to high quality musculoskeletal care. , a potential for serving this need-especially during the covid- pandemic when patients may be reluctant to receive care outside of their homes-includes early access to home exercise programs and physical therapy. historically, early access to this care has been associated with significant improvements in clinical outcomes at lower cost (from fewer surgeries, imaging tests, and invasive procedures). , for patients who are not candidates for home exercise or physical therapy, triage to higher levels of care is a necessary component of a comprehensive musculoskeletal care pathway. the purpose of this study was to evaluate a novel musculoskeletal care coordination service that attempts to engage employees in their course of musculoskeletal pain and guide them through an evidence-based, cost-effective care journey. this service has not been rigorously evaluated in the employer setting. thus, our specific objective was to provide an evaluation of a pilot of the musculoskeletal care coordination service in an urban population of adult employees with either acute or chronic musculoskeletal complaints. we hypothesized that engagement with the service would result in improvements in three key outcomes: clinical outcomes (pain, physical function, and mood), workplace productivity, and participant satisfaction. eligible participants were recruited by email and at employersponsored ergonomic and health events. we included all participants enrolled in the risalto musculoskeletal care coordination service from january to december , . these participants were adult comcast nbcuniversal employees and their dependents (age ! y) living in the philadelphia metropolitan area with self-identified knee, hip, back, or other musculoskeletal complaints. the service is provided by care coordinators who are certified health and wellness coaches with at least four years of experience. before interacting with participants, they received an intensive week training on the biopsychosocial model of musculoskeletal care (which involves approaching patients' pain experience and biomechanics in a supportive environment that encourages movement and active therapy), clinical practice guidelines for musculoskeletal care; coaching modules on topics such as goal setting, activity and sleep counseling, coping with pain, and relaxation exercises; use of the care coordination technology that structures both the patient questions and the development of the care plan; referral management processes; and follow-up protocols. in the recruitment materials, participants were given a phone number and access to an online portal to schedule an initial consultation with a musculoskeletal care coordinator who screened them for eligibility in the pilot. eligible participants were then given a baseline assessment during which they were asked to provide structured data specific to their musculoskeletal complaint including site of musculoskeletal pain; duration and severity of symptoms; symptoms consistent with depression or anxiety; pain (on a likert scale were was rated as ''no pain at all'' and was rated as ''the worst pain imaginable''); impact of pain on physical functioning (on a likert scale were was rated as ''no interference with general day-to-day activity'' and was rated as ''completely unable to do day-to-day activity''). participants were also asked about their treatment preferences (eg, willingness to engage in home exercise, seeking a recommendation for a neurosurgeon or imaging center, willingness to accept a referral to the comcast nbcuniversal employee assistance program [eap] for behavioral health support). the specific baseline assessment questions varied by clinical scenario and were all taken from validated questionnaires (eg, general issues were measured by questions from the validated promis , low back pain questions were taken from the oswestry, hip pain questions were taken from the hoos, jr, and knee pain questions were taken from the koos). participants flagged as moderate or high risk for a behavioral health issue the on the promis, were asked additional behavioral health questions taken from the phq- and gad- for depression and anxiety respectively. care coordinators used the data from the baseline assessment to rule out ''red flags'' suggestive of a serious condition (eg, history of cancer, significant neurological findings, bowel or bladder compromise, history of surgery). if a red flag was present, participants were referred for an urgent specialist consultation. on the basis of these data, participants were triaged into the relevant care pathway (eg, home exercise, referral for physical therapy, referral for physiatry). care pathways were based on well-established clinical guidelines and a rigorous review of the evidence for each clinical condition (eg, for low back pain, [ ] [ ] [ ] [ ] [ ] hip pain, - knee pain [ ] [ ] [ ] [ ] [ ] [ ] [ ] . each participant was paired with a care coordinator who was responsible for that participant's journey through their care plan. they followed participants at least weekly (but sometimes as often as daily) until month after their graduation from their care pathway via secure text or phone to assess their progress. condition-specific clinical status questions were asked weekly. regardless of pathway, participants were also offered coaching for pain management, stress reduction, sleep management, cognitive reframing and coping strategies, activity pacing, relaxation exercises, weight loss, and goal setting. during each follow-up visit, care plans were updated based on clinical progress. participants who did not engage in follow-up visits were contacted by their preferred means (telephone, text, email) three times over a two week period with encouragement to re-engage. the outcomes of interest for each participant included: ) engagement (measured both as the proportion of participants who adopted at least one recommended action (eg, start a home exercise program) and the proportion of participants who completed their expected care plan); ) clinical outcomes (ie, change in pain, functional status, and mood scores); ) productivity (measured using a single item from the workplace presenteeism and absenteeism inventory [wpai]) , that asked on a to visual analog scale: ''during the past seven days, how much did your musculoskeletal pain affect your productivity while you were working?'' where represented ''no effect on my work'' and represented ''completely prevented me from working''; and ) participant satisfaction (measured on a -point likert scale where is ''completely dissatisfied'' and is ''completely satisfied'' and with a single item net promoter score [nps] that asked participants to rate, on a scale from À to þ , ''how likely is it that you would recommend the risalto service to a friend or colleague?''). all participant baseline calls were reviewed by senior clinical staff within hours. additionally, participants reporting severe clinical symptoms (eg, severe pain, reporting suicidality on the phq ) were immediately connected to the appropriate care provider (eg, the eap) and flagged for urgent review by senior clinical staff. participants did not incur incremental costs associated with the care coordination service and did not receive any incentives for study participation. the home exercise program and coaching by care coordinators were provided at no cost to participants. participants used their healthcare benefits for physical therapy, imaging, and specialist visits (for participants in their deductible or coinsurance phases of their benefits, this would have resulted in out-of-pocket expenses). we used univariate analyses to describe the outcomes of interest for participants in each of the care pathways. we compared outcomes at baseline and graduation with paired t-tests and considered p values < . to be statistically significant. to evaluate the association among the outcomes of interest we calculated pearson correlation coefficients and manova. this protocol received irb approval (aspireirb protocol number xorisalto , december , ). we conducted all statistical analyses in excel v . . two hundred sixty-nine participants were screened and met inclusion criteria and completed their baseline assessment. table presents the demographic and clinical characteristics of these participants. participants' mean age was . years (sd some participants who were lost to follow-up had progressed on their care plan (eg, accepted a referral to a specialist). . y, range from to y). low back pain was the most common musculoskeletal issue ( [ %] participants). overall, ( % of) participants were triaged to home exercise and ( %) were triaged to physical therapy; although the types of care differed by body part (table ). only ( %) participants required a medical referral and more than half of those were to physiatry. notably, although participants could only be on one care pathway at a time, some participants with multiple musculoskeletal issues were on more than one care pathway during the pilot. of the participants who completed their baseline evaluation, ( %) participants completed their care plan. among those who completed their care plans, the average call duration with a care coordinator was minutes per call ( fig. ) with initial calls averaging minutes and subsequent calls averaging minutes. on average, participants texted times with the service. the specific engagement modality used (text vs call) was based on participant preference and the content of the calls and texts was identical. the vast majority of participants ( %) took at least one recommendation made by their care coordinator. among those participants who did not take a recommended action, many reported that they would schedule an appointment with a recommended provider themselves; however, the extent to which that happened could not be verified. on average, participants completed their care pathway in . (sd . ) weeks (table ) . hip pain patients tended to graduate from their care pathways most quickly and the neck and low back pain patients required longer treatment periods. among the participants who completed their care plan, provided both baseline and final pain assessments (range - ; a change of greater than can be considered to be clinically relevant). their baseline pain score decreased from . (sd . ) to . (sd . ) (fig. a) . thirty-one participants ( %) had a change in their eap, employee assistance program. Ã participants who reported behavioral health symptoms were referred to their eap in addition to their primary musculoskeltal pathway. y exception refers to those participants who were not eligible for risalto services and referred out for other care. z other refers to a non-standard care pathway (eg, for ankle or other body part for which there was not a standard pathway). pain score of or more. three participants ( %) had no change in their pain scores. three participants ( %) had higher final pain scores than at baseline but reported qualitative improvement, considered the pain to be well controlled, and requested that they be graduated from the program. among the participants who completed their care plan, provided both baseline and final physical functioning scores (range - ; a change of greater than can be considered to be clinically relevant). their average physical functioning score improved from . (sd . ) at baseline to . (sd . ) at graduation (fig. b ). ten participants ( %) had a change in their pain impact score of or more. five participants ( %) reported their pain had a greater impact on daily activity at their final measurement but requested that they be graduated from the program. behavioral health issues were common among participants: ( %) participants were referred to their eap (table ) . of these, participants accepted this referral. among the participants who completed their care plan, ( %) provided both baseline and final mood impact scores (range - ; a change of greater than can be considered to be clinically relevant). their average score improved from a baseline of . (sd . ) to . (sd . ) at plan completion (fig. c) . eleven participants ( %) had a change in their mood impact score of or more. five participants ( %) reported worse mood scores at their final measurement than at baseline. at baseline, participants (out of , . %) reported that their musculoskeletal issue did not affect their productivity (ie, wpai score of ) (fig. ) . among the participants who completed their care plan, ( %) provided both baseline and final wpai scores. their average baseline wpai was . (sd . ) which improved to . (sd . ) (p > . for change). five participants were fully productive (wpai score ¼ ) upon completion of their care plan and five other participants indicated some improvement in productivity scores. six participants reported greater impairment to productivity at their final assessment (including four participants who had a baseline score of ). overall participant satisfaction was high across all programs and pathways with an average score of . (on a scale from - ). participants were highly likely to recommend the care coordination service to others (nps ; on a scale from À to þ ). when asked to identify their favorite aspects of the program, % of participants cited the tailored care, % the relationship with their care coordinator, and % the convenience and overall service. when asked for their least favorite aspects of the program were, % of participants cited the questionnaires, % the calls during work hours, and % that there was no video interaction. overall, the clinical outcomes were highly correlated: improvement in pain was associated with improvement in physical function (r ¼ . , p < . ), in mood (r ¼ . , p < . ), and in productivity (r ¼ À . , p ¼ . ). taken together, we found that older age, increased engagement (as measured by the number of sms messages sent to their coach); improvement in overall pain, physical function, and mood were all highly associated (anova p ¼ . e- ) ( table ) . increasingly, large employers are implementing care navigation services to help employees and their families maximize their health benefits and find high-quality, evidence-based care. most of these services are general in nature (ie, not condition-specific) and handle a wide variety of employee questions (eg, benefits coverage issues, medical bill reconciliation, finding a provider). this study, the first of a novel, employer-sponsored musculoskeletal-specific care coordination service, has four key findings: first, employee populations with musculoskeletal issues are willing to engage with a service aimed at directing them to evidence-based care. moreover, a remarkable % of participants were willing to do home exercises or physical therapy rather than seeking more expensive specialist referrals and imaging tests. although an economic analysis of the effects of steerage to lower intensity services was outside the scope of this study, we recommend that it be included in a future analysis. second, participants experienced improvements in pain and physical function. we speculate that the standardization of care for patients with musculoskeletal pain through the use of the care pathways was a key driver of the observed clinical improvements. others have found that evidence-based, standardized care pathways have been associated with cost savings and improved outcomes, including pain reduction and improved patient satisfaction. third, access to this musculoskeletal care coordination service was associated with improvements in self-reported workplace productivity. not surprisingly productivity improved in concert with improvements in pain, physical function, and mood. this finding warrants further exploration both with more detailed self-reported absenteeism and presenteeism measures and with direct measurement of workplace productivity. finally, participants were highly satisfied with their care. the nps of compares highly favorably with other healthcare entities (eg, cvs health [À ], cigna [À ], walgreens [ ] , kaiser healthcare). all participants included in this evaluation chose to work with their employer-sponsored care coordinator. this self-selection may have contributed to the excellent reported satisfaction with their experience. the limitations of this evaluation include relatively small sample sizes for some of the care pathways, especially among those figure . change in productivity. the wpai , asks on a to visual analog scale: ''during the past seven days, how much did your musculoskeletal pain affect your productivity while you were working?'' where represents ''no effect on my work'' and represents ''completely prevented me from working.'' wpai, workplace presenteeism and absenteeism inventory. completing the program. moreover, the rate of loss to follow-up was relatively high, potentially skewing the results in favor of the coordination service. although the clinical outcomes were all based on items from validated instruments, the lack of data from complete scales prevented comparisons to outcomes previously reported in the literature. we recommend that a future evaluation of this program use validated instruments in their entirety, at least for a selected population (eg, low back pain patients) using the service. in addition, claims-based analyses might facilitate a more complete understanding of whether participants took the referral recommendations made by this service. these results suggest that employers with populations in whom musculoskeletal complaints are common might benefit from integrating a musculoskeletal care coordination service in their benefits offering. descriptive epidemiology of low-back pain and its related medical care in the united states. spine (phila pa ) estimates of the prevalence of arthritis and selected musculoskeletal disorders in the united states low back pain takes toll on worker health and productivity. integrated benefits institution large employers' health care strategy and plan design survey preventing and treating musculoskeletal disorders: new strategies for employers. northeast business group on health impact of a musculoskeletal disability management program on medical costs and productivity in a large manufacturing company the biopsychosocial approach to chronic pain: scientific advances and future directions the patient-reported outcomes measurement information system (promis) developed and tested its first wave of adult self-reported health outcome item banks oswestry disability index hip disability and osteoarthritis outcome score (hoos)-validity and responsiveness in total hip replacement the knee injury and osteoarthritis outcome score (koos): from joint injury to osteoarthritis the phq- : validity of a brief depression severity measure validation and standardization of the generalized anxiety disorder screener (gad- ) in the general population european guidelines for the management of chronic nonspecific low back pain interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the american pain society interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the american pain society a brief overview of evidence-informed management of chronic low back pain with surgery evidence-informed management of chronic low back pain with functional restoration effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial hip pain and mobility deficits-hip osteoarthritis: clinical practice guidelines linked to the international classification of functioning, disability, and health from the orthopaedic section of the american physical therapy association efficacy of patient education and supervised exercise vs patient education alone in patients with hip osteoarthritis: a single blind randomized clinical trial exercise and manual physiotherapy arthritis research trial (empart) for osteoarthritis of the hip: a multicenter randomized controlled trial aaos clinical practice guideline: management of osteoarthritis of the hip long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized controlled trial comparing two different physical therapy interventions treatment of knee osteoarthritis: a clinical practice guideline from the aaos aaos clinical practice guideline: treatment of osteoarthritis of the knee: evidence-based guideline the american academy of orthopaedic surgeons evidence-based guideline on: treatment of osteoarthritis of the knee nonsurgical management of knee pain in adults oarsi guidelines for the non-surgical management of knee osteoarthritis the american academy of orthopaedic surgeons evidence-based guideline on management of anterior cruciate ligament injuries aaos clinical practice guideline: surgical management of osteoarthritis of the knee: evidence-based guideline validity, reliability and responsiveness of the work productivity and activity impairment questionnaire in ankylosing spondylitis the validity and reproducibility of a work productivity and activity impairment instrument net promoter score explained a hospitalbased standardized spine care pathway: report of a multidisciplinary, evidence-based process key: cord- -gwkxxkuu authors: cleland, brice t.; galick, melissa; huckstep, amy; lenhart, laura; madhavan, sangeetha title: feasibility and safety of transcranial direct current stimulation in an outpatient rehabilitation setting after stroke date: - - journal: brain sci doi: . /brainsci sha: doc_id: cord_uid: gwkxxkuu transcranial direct current stimulation (tdcs) has strong potential for outpatient clinical use, but feasibility and safety of tdcs has only been evaluated in laboratory and inpatient clinical settings. the objective of this study was to assess feasibility and safety of tdcs for stroke in an outpatient clinical setting. individuals with stroke in outpatient therapy received tdcs during physical therapy sessions. feasibility was assessed with screening, enrollment, withdrawal, and adherence numbers, tdcs impressions, and perceived benefits and detriments of tdcs. acute changes in fatigue and self-reported function and pre-post changes in fatigue were also assessed. safety was assessed as adverse events and side effects. in total, individuals were screened, and were enrolled. most exclusions were unrelated to clinical feasibility. in total, participants withdrew, so participants completed sessions/week for – weeks with % adherence. in total, % reported positive impressions of tdcs. tdcs setup decreased to – min at end of study. there was one adverse event unrelated to tdcs. mild to moderate side effects (tingling, itching, pinching, and fatigue) were experienced. in total, % of participants recounted benefits of tdcs. there were acute improvements in function and energy. results support the feasibility and safety of tdcs in an outpatient clinical setting. stroke affects~ , people each year in the united states and is a major cause of long-term disability [ , ] . individuals with stroke experience impairments in the upper extremity (e.g., grip strength, dexterity, and motor control) and the lower extremity (e.g., balance, walking, and mobility) which limit activities of daily living [ ] . the impact of stroke rehabilitation on impairment varies, with many individuals not regaining optimal function [ , ] . one potential explanation for why stroke rehabilitation may have a limited impact on long-term disability is the interhemispheric competition model [ ] . this model describes an imbalance in interhemispheric inhibition excitability that may limit motor output and recovery on the more affected side [ ] . to address hemispheric imbalance and promote recovery, recent investigations have used neuromodulation in combination with motor training to increase the excitability of the lesioned hemisphere and/or decrease the excitability of the non-lesioned hemisphere. one of the most commonly used modalities is transcranial direct current stimulation (tdcs), which involves the application of non-invasive low intensity direct currents to the scalp, altering the membrane potentials that affect neuronal excitability in the underlying cortical tissue [ ] . both tdcs and motor training can yield long-term effects through mechanisms similar to long-term potentiation and long-term depression. the combination of both interventions may yield greater neuroplasticity and functional improvement than either alone [ , ] . a large body of studies has elucidated the neurophysiological basis of tdcs and demonstrated facilitation of cognitive and motor processing and learning in the healthy and damaged brain [ ] [ ] [ ] . promising results with post-stroke motor rehabilitation have advanced treatment with tdcs to class i level for the upper extremity [ ] . in the lower extremity, tdcs can enhance strength, motor control, mobility, and balance [ ] [ ] [ ] [ ] [ ] [ ] and may enhance improvements in walking speed and endurance when paired with gait training [ , ] . tdcs also appears to be safe, easy to use, and cost-effective. a recent review of data from , research sessions found no evidence of serious adverse events and found that tdcs does not cause neuronal damage at levels used in research in a variety of populations [ ] . there is also considerable support for the safety of tdcs in the post-stroke population [ ] and for the safety of home-based tdcs [ , ] . tdcs is relatively easy to use, as exemplified by the feasibility of home-based applications in multiple populations, including stroke [ ] [ ] [ ] . finally, tdcs units are small and cost as little as a few hundred dollars. in a research setting, tdcs appears to be efficacious and safe. considering that tdcs is also tolerable, easy to use, portable, and cost-effective, it has strong potential for use in a clinical setting [ ] . surprisingly, despite the large number of tdcs studies conducted in the laboratory, there is a dearth of studies that have been done in a clinical setting. two studies have evaluated feasibility and safety of tdcs in an inpatient clinical setting in acute stroke [ , ] . however, to our knowledge, there have been no investigations into the safety and feasibility of tdcs in an outpatient clinical setting. safety and feasibility in laboratory and inpatient settings may not translate to the outpatient clinical setting because of differences in environmental control and factors affecting clinician and patient attitudes and acceptability of a research modality. hence, the objective of this exploratory study was to determine the feasibility and safety of using tdcs in an outpatient clinical setting. all participants were recruited from the patient pool at the shirley ryan abilitylab homewood dayrehab center, homewood, il, usa. participants were enrolled if they were - years old, had a clinical history of single unilateral stroke and were scheduled to receive at least weeks of gait training after the commencement of the study. participants were excluded if they had contraindications to tdcs, including: history of epilepsy or seizures, use of a pacemaker, skin hypersensitivity, contact dermatitis, allodynia and/or hyperalgesia, or any other skin or scalp condition that could potentially be aggravated by tdcs. participants were also excluded if they were pregnant, had neurological conditions besides stroke, or were unable to perform at least min of walking on a treadmill or stepping on a recumbent stepper. this study was conducted in accordance with the declaration of helsinki, the protocol was approved by the northwestern university irb (stu ), and all participants provided written informed consent. information such as date, location, and type of stroke, tests of physical function, and activities performed during rehabilitative treatment were extracted from patient records. deidentified data that underlie study results will be shared by the corresponding author upon reasonable request from qualified investigators. all participants received ongoing rehabilitative treatment at the homewood dayrehab center (part of the shirley ryan abilitylab, chicago, il, usa), an outpatient neurorehabilitation center that provides therapy services to~ patients per day. typically, patients undergo treatment - days per week for h (half day) or h (full day). each day is split up into -min sessions, and each session focuses on one discipline: physical therapy, occupational therapy, or speech therapy. the specific daily and weekly schedule is individualized for each patient. prior to the start of the study, physical therapist clinicians received~ h of instruction, training, and practice in the application of tdcs from research scientists with extensive experience in the use of tdcs. training included a didactic lecture on the scientific premise and physiological basis of tdcs and hands-on activities to ensure proper landmark identification, electrode application, current administration, and troubleshooting. training was provided to clinicians, of whom were ultimately involved in study procedures. the other clinicians relocated or had other professional obligations. tdcs was performed twice per week during a physical therapy session that focused on gait training. the application of tdcs was incorporated into the standard time for the treatment session ( min) and applied during the~ -min warmup exercise performed at each participant's comfortable intensity and personalized based on each patient's baseline self-selected gait speed. warmup exercise was performed on a recumbent stepper (gait speed ≤ . m/s) or a treadmill (gait speed > . m/s). to prepare for tdcs, the vertex was identified as the intersection of the midline from the nasion to the inion and the midline from tragus to tragus. the vertex was marked with indelible marker. the leg representation of the ipsilesional motor cortex was approximated as cm posterior and cm lateral from the vertex and marked with indelible marker [ ] . saline-soaked sponge electrodes (~ × cm; caputron, new york city, ny, usa) were placed over the leg representation of the ipsilesional motor cortex (anode) and the contralesional supraorbital region (cathode). electrodes were secured with an elastic wrap or headband. the electrodes used in this study are designed for multiple use, and each participant used their own pair of electrodes for all sessions. anodal tdcs was applied with a constant current stimulator, chattanooga ionto (djo global, lewisville, tx, usa). after a -s ramp-up, ma current was applied for min. the current density was . ma/cm , and the total charge was . c/cm , which were within safety limits [ ] . tdcs duration was selected to be within the safety parameters used in previous studies in individuals with stroke [ , ] . tdcs was applied during warmup exercise because applying tdcs prior to motor training may optimize neuroplasticity [ , ] . the chattanooga ionto was selected for this study because it allows easy application of tdcs and is low-cost, portable, and adaptable. users can apply between . and ma of constant current (regardless of skin impedance) with an automatic -s ramp up and down to two different sites simultaneously. the device is available for usd~ and is pocket-sized (dimensions: × × cm; mass: < kg). users can interface with the device with a variety of reusable or single-use electrode types. after warmup, tdcs equipment was turned off and removed, and high-intensity treadmill walking or overground gait training were performed. for high-intensity exercise, intensity was constantly modulated with the goal of obtaining a rating of perceived exertion (rpe; borg - scale [ ] ) between and . intensity was modified by increasing speed, increasing treadmill incline, decreasing external support, decreasing the number and duration of rest breaks, and adding ankle weights. to characterize warmup and high-intensity exercise, duration, speed, and rpe were recorded. the number of patients screened and enrolled for the study was recorded, along with reasons for enrollment refusal and study withdrawal. for each participant, the number of sessions and weeks completed and adherence to the use of tdcs was recorded. to assess acute (within-session) changes in fatigue and function, participants completed the rating-of-fatigue scale (rof; a maximal rating of represents total fatigue and exhaustion) [ ] and the patient-specific functional scale (psfs; a maximal rating of represents no functional limitation) [ ] before and after the application of tdcs. to assess pre-post changes in fatigue, participants completed the visual analogue fatigue scale (vas-f) [ ] before the first and after the last tdcs session. after the last tdcs session, participants completed a survey assessing their attitudes and impressions about tdcs, its feasibility and benefits, and barriers to use of this intervention (appendix a). impressions, perceptions, and suggestions were recorded from the study clinicians via interview. the number of adverse effects associated with the application of tdcs was actively monitored during the study. in addition, any participant who reported intolerable discomfort or pain related to the application of tdcs or any other study procedures was planned to be removed from the study. withdrawals and adverse effects were recorded. after completing the last session involving tdcs, participants completed a survey assessing tdcs-related side effects (appendix b), largely based on work by fertonani, ferrari, and miniussi [ ] . related-samples wilcoxon signed-rank tests were performed to compare rof, psfs, and vas-f measures from the start to end of the tdcs session (rof, psfs) and from pre to post study (vas-f). statistical analyses were performed with ibm spss statistics . a p-value of . was accepted as significant. in total, individuals were screened between november to february for participation in this study after referral to the clinic with a diagnosis of stroke and/or recommendation for study consideration by their treating therapist. most of these ( %) failed screening because they had history of multiple strokes, another neurological condition, or were greater than years old. screening identified eligible individuals with stroke who were recruited, provided informed consent, and started the study. of these, participants withdrew from the study after enrollment because: ( ) decreased mood that limited accurate feedback and engagement, ( ) aphasia prevented accurate feedback to clinicians, and ( ) other undisclosed personal reasons. thus, data from participants who received tdcs were included in the final analyses. a flow chart is shown in figure , and demographics are presented in table . comorbidities included: hypertension (n = ), type ii diabetes (n = ), cardiac surgery (n = ), atrial fibrillation (n = ), obesity (n = ), and chronic tobacco use (n = ). participants completed - sessions distributed as sessions/week for - weeks. attendance and transcranial direct current stimulation (tdcs) application rate for scheduled sessions were %. in two participants, sessions were completed for instead of weeks. one participant was removed from the study because of a hypoglycemic event (see safety section below); the study was discontinued in another participant because of the severe acute respiratory syndrome coronavirus (sars-cov- , covid- ) pandemic. across all participants and sessions, mean (standard deviation) warmup duration was . ( . ) min and high intensity training duration was . (table ) . vas-f energy rating increased from before the first tdcs session to after the last tdcs session ( table ; z = − . , p = . ). there was no change in vas-f fatigue or total rating (p ≥ . ). participants completed - sessions distributed as sessions/week for - weeks. attendance and transcranial direct current stimulation (tdcs) application rate for scheduled sessions were %. in two participants, sessions were completed for instead of weeks. one participant was removed from the study because of a hypoglycemic event (see safety section below); the study was discontinued in another participant because of the severe acute respiratory syndrome coronavirus (sars-cov- , covid- ) pandemic. across all participants and sessions, mean (standard deviation) warmup duration was . ( . ) min and high intensity training duration was . (table ) . vas-f energy rating increased from before the first tdcs session to after the last tdcs session ( table ; z = − . , p = . ). there was no change in vas-f fatigue or total rating (p ≥ . ). table . acute and pre-post effects of tdcs on fatigue and function. averages for the rating-of-fatigue scale (rof; point maximum) and patient-specific functional scale (psfs; point maximum) are shown from before and after each tdcs and exercise session. visual analogue fatigue scale (vas-f) values are shown from the start of the study to the end ( - weeks later). values are mean (standard deviation). * p < . between pre and post. in the post-study survey about tdcs, participants reported that they prospectively had expected tdcs to benefit their walking (n = ), brain (n = ), flexibility (n = ), talking (n = ), legs (n = ), and strength (n = ). retrospective, self-reported benefits of tdcs were improvements in walking (n = ), community walking (n = ), energy (n = ), balance (n = ), standing (n = ), dressing (n = ), overall physical function (n = ), back (n = ), and arm (n = ). on average, participants gave an agreement rating of ≥ . / for all perceived benefits of tdcs and gave an agreement rating of . / for the perceived detriment of more fatigue (figure ). in total, participants reported positive impressions of tdcs, reported some worries about potential side effects, and did not convey their impressions. aspects that participants reported liking about tdcs included: perceived improvements in walking (n = ), the short duration of the intervention (n = ), the convenience of the location (n = ), and the skill of study clinicians (n = ). in total, participants indicated that they liked the frequency of tdcs, while indicated that they would have liked a greater frequency. only two dislikes were noted: the comfort of the headbands used (n = ) and the overall comfort of tdcs (n = ). the only suggested changes were to improve the comfort of the headbands (n = ) and to increase the frequency of tdcs (n = ). brain sci. , , x for peer review of in the post-study survey about tdcs, participants reported that they prospectively had expected tdcs to benefit their walking (n = ), brain (n = ), flexibility (n = ), talking (n = ), legs (n = ), and strength (n = ). retrospective, self-reported benefits of tdcs were improvements in walking (n = ), community walking (n = ), energy (n = ), balance (n = ), standing (n = ), dressing (n = ), overall physical function (n = ), back (n = ), and arm (n = ). on average, participants gave an agreement rating of ≥ . / for all perceived benefits of tdcs and gave an agreement rating of . / for the perceived detriment of more fatigue (figure ). in total, participants reported positive impressions of tdcs, reported some worries about potential side effects, and did not convey their impressions. aspects that participants reported liking about tdcs included: perceived improvements in walking (n = ), the short duration of the intervention (n = ), the convenience of the location (n = ), and the skill of study clinicians (n = ). in total, participants indicated that they liked the frequency of tdcs, while indicated that they would have liked a greater frequency. only two dislikes were noted: the comfort of the headbands used (n = ) and the overall comfort of tdcs (n = ). the only suggested changes were to improve the comfort of the headbands (n = ) and to increase the frequency of tdcs (n = ). clinicians involved in the study reported that the tdcs setup time decreased from min at the start of the study to - min at the end of the study. setup was identified as a task that could be completed by rehab technicians. clinicians noted that because priming took min, participants were limited to - min of high intensity gait training. the study clinicians also suggested that it may be clinicians involved in the study reported that the tdcs setup time decreased from min at the start of the study to - min at the end of the study. setup was identified as a task that could be completed by rehab technicians. clinicians noted that because priming took min, participants were limited to - min of high intensity gait training. the study clinicians also suggested that it may be beneficial to do some of the high intensity training on a recumbent stepper in combination with tdcs. finally, the clinicians subjectively noted that participants receiving tdcs had an increased awareness, commitment, and investment in their treatment plan of care. of the participants, one was removed from the study because of an adverse event. in this individual, the th session was stopped during high intensity treadmill walking because the participant had a hypoglycemic event (blood glucose = mg/dl). the participant was transferred to a supine position with lower extremity elevated, and orange juice and a granola bar were provided. the participant's family reported that the participant had experienced high blood sugar prior to the treatment session, and insulin had been administered. this participant continued with rehabilitative treatment but was withdrawn from the study. in the post-study survey of tdcs-related side effects, five participants reported mild to moderate side effects from tdcs. reported side effects were mild to moderate tingling (n = ), mild itching (n = ), mild to moderate fatigue (n = ), and mild pinching (n = ). focal side effects were felt in the vicinity of the tdcs electrodes. side effects were reported at the beginning (n = ), middle (n = ), and end (n = ) of the stimulation, or throughout the entirety of stimulation (n = ). no participants reported that side effects affected their performance, and no pain was reported. in this preliminary study, we found evidence that tdcs is feasible and safe for persons with stroke with other co-morbidities when applied in an outpatient clinical setting. impressions of tdcs were positive, and participants completed the tdcs sessions without any adverse events. self-reported benefits of the treatment provide preliminary support for the efficacy of tdcs applied in a clinical setting. our results support the feasibility of applying tdcs in an outpatient clinical setting. during the eligibility assessment, most potential participants were excluded for reasons related to internal validity (e.g., multiple strokes, other neurological conditions, or age), not because of contraindications to tdcs. overall, % ( out of ) of the individuals who were screened could have been included in the study if not for these internal validity controls. it is likely that it would be safe for a large portion of the outpatient rehabilitation clinical population to receive tdcs as part of their plan of care [ ] . of the three participants who withdrew after enrolling in the study, one withdrew because they could not communicate well enough to complete study assessments (aphasia). this likely would not preclude the application of tdcs under normal clinical circumstances. considering a % withdrawal rate (based on out of enrolled participants), we estimate that % of the clinical population ( out of ) could have received tdcs. these results suggest that it is likely that tdcs would be feasible for a large portion of the outpatient clinical population to receive tdcs as part of their plan of care after stroke. this conclusion is in accordance with studies suggesting the feasibility of inpatient tdcs application in acute stroke [ , ] . additionally, it may be feasible for even more of the clinical population to receive tdcs if some unnecessary traditional exclusion criteria are omitted [ ] . participants who received tdcs tolerated the treatment well and attended all sessions. response to warmup and high intensity exercise appeared to be normal. we found evidence of acute reductions in perceived physical function limitation and pre-post improvements in perceived energy. if tdcs improves patient energy levels, this may provide an added benefit for individuals experiencing low energy levels, especially after stroke. however, it is interesting to note that fatigue symptoms did not change from pre to post study. although fatigue is a common acute side effect of tdcs [ , ] , and our participants reported acute increases in fatigue (rof), our findings suggest that these changes in fatigue are not long-term. furthermore, tdcs may reduce fatigue in populations with chronic fatigue (e.g., multiple sclerosis, fibromyalgia, and chronic fatigue syndrome) [ ] , but our study does not support a role of tdcs for fatigue reduction in the post-stroke population. six out of seven ( %) participants recounted perceived benefits of tdcs, including improved walking. this coincides with a number of publications demonstrating the potential benefits of tdcs for lower limb movement [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] ] . furthermore, five out of seven ( %) participants reported positive impressions of tdcs and that they had expected to benefit from the treatment in a variety of ways. five out of seven ( %) participants indicated that they liked the frequency of tdcs, and four out of seven ( %) liked the perceived improvements in walking. in fact, two of our participants indicated that they would have liked tdcs for a longer duration. only two out of seven ( %) participants reported minor issues with the comfort of the treatment (tdcs overall and headbands). issues with the comfort of headbands or elastic wrap used to secure tdcs electrodes may be addressed with single-use adhesive electrodes. this approach would likely reduce setup time and discomfort, although the adhesive may not be strong enough to hold throughout exercise. in this study, we chose reusable sponge electrodes secured with headbands and elastic wrap because this approach is less expensive, which may be desired in a clinical setting. our findings suggest that clinicians should be able to rapidly establish patient support for the use of tdcs in their treatment regimen, as seen in home-based tdcs applications after stroke [ ] . this is supported by clinicians' report of increased participant awareness, commitment, and investment in their treatment plan of care. clinicians were eager to use tdcs (based on previous knowledge regarding the priming effects on motor recovery), and the two clinicians who did not participate did so for non-tdcs related reasons. required setup time decreased with experience, eventually only requiring - min, which can be easily incorporated into the standard treatment. as noted, setup could be performed by rehab technicians to decrease clinician burden and maximize time spent on skilled intervention. as found in this study, greater use of tdcs by clinicians will likely provide insights into ways to optimize this treatment in the outpatient clinical setting. there was one adverse event that took place during this study, which appeared to be unrelated to the administration of tdcs. study participants noted mild to moderate side effects from tdcs, including tingling, itching, pinching, and fatigue. most of these side effects were only experienced during current ramp up or ramp down. consistent with our findings, some of the most commonly reported side effects in the healthy and post-stroke population are tingling and itching [ , ] . it is also important to note that no participants reported that side effects affected their performance, no pain was reported, and symptoms were mild enough that participants chose to continue with the treatment sessions. overall, these findings are consistent with previous research supporting the safety of tdcs [ , ] . however, researchers need to be diligent about checking contraindications to tdcs prior to application [ ] . our findings provide preliminary support for feasibility and safety of tdcs in an outpatient clinical setting, but our conclusions are limited by several factors. our sample size was small (n = ), which may have limited interpretations of our results. however, our sample size is consistent with other demonstrations of tdcs feasibility in stroke in other settings [ , ] . although our results support feasibility, there are limitations to immediate clinical implementation of tdcs. one limitation is that there is no insurance coverage for tdcs currently. thus, use of tdcs may require out-of-pocket coverage. another limitation is that, although tdcs devices are widely available, the safety of these devices has not been determined, and clear regulation is not present. for example, common iontophoresis devices do not have safety limits on current output and are not designed for application to the scalp [ ] . finally, the study clinicians noted that because the tdcs time ( min) was longer than typical warmup exercise, the amount of high intensity training was slightly decreased. in the future, a more effective strategy may be to gradually increase the intensity of exercise throughout the application of tdcs so therapy time is not affected. for example, after - min of low-intensity exercise, the intensity can be increased throughout the remainder of tdcs. in this study, we found preliminary evidence that the use of tdcs in an outpatient clinical setting is feasible and safe. further research is needed to determine the efficacy of this treatment, and insights from clinicians can help optimize application of tdcs in the clinic. • none = i did not feel the described sensation ( ) • mild = i mildly felt the described sensation ( ( ) when did any discomfort begin? at the beginning of the stimulation at approximately the middle of the stimulation towards the end of the stimulation ( ) how long did it last? it stopped quickly it stopped in the middle of the stimulation it stopped at the end of the stimulation ( ) how much did these sensations affect your performance? not at all slightly considerably much very much ( ) were these sensations located over the head or in a different location? on the head ____________________________ other____________________________ ( ) if you experienced any pain during the electrical stimulation, please mark how much your pain was on this scale from to . 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( ) did you experience any discomfort or annoyance during any session involving electrical stimulation? please answer the following questions regarding the different sensations and indicate the degree of intensity of your discomfort according to the following scale: