key: cord-313615-cts45n3j authors: Tam, John S; Barbeschi, Maurizio; Shapovalova, Natasha; Briand, Sylvie; Memish, Ziad A; Kieny, Marie-Paule title: Research agenda for mass gatherings: a call to action date: 2012-01-15 journal: Lancet Infect Dis DOI: 10.1016/s1473-3099(11)70353-x sha: doc_id: 313615 cord_uid: cts45n3j Public health research is essential for the development of effective policies and planning to address health security and risks associated with mass gatherings (MGs). Crucial research topics related to MGs and their effects on global health security are discussed in this review. The research agenda for MGs consists of a framework of five major public health research directions that address issues related to reducing the risk of public health emergencies during MGs; restricting the occurrence of non-communicable and communicable diseases; minimisation of the effect of public health events associated with MGs; optimisation of the medical services and treatment of diseases during MGs; and development and application of modern public health measures. Implementation of the proposed research topics would be expected to provide benefits over the medium to long term in planning for MGs. A mass gathering (MG), as defi ned by WHO, is "any occasion, either organized or spontaneous, that attracts suffi cient numbers of people to strain the planning and response resources of the community, city or nation hosting the event". 1 MGs can be spontaneous or organised and include sports events, social or cultural functions, gatherings of displaced populations due to natural disasters or war, and political or religious congregations. [2] [3] [4] [5] Major MGs are likely to involve communities from diff erent parts of the world. Participants and host and home communities face health risks that are of international concern. Therefore, the control of infectious diseases and provision of medical services for non-communicable dis eases and other risks to health are increasingly important in the planning for MGs. Risks commonly associated with MGs include health systems having to accom modate a surge in capacity; challenges to existing health interventions; introduction and transmission of non-endemic diseases during and after MGs; diffi culties associated with risk communication to participants from diff erent cultures; and those arising because of the high profi le of some events, such as security risks. International MGs can amplify the transmission of infectious diseases, and infections can spread from the home to the host community during travel to and from the event and from the host to the home community on return. 6 Such events can pose substantial risks to global health security and present challenges for surveillance of the spread of such diseases to new ecological settings and vulnerable populations. 7 In addition to risks of infectious diseases during MGs, non-communicable risks include cardiovascular diseases, environment-related heat injury, fi re-related injury, illnesses related to use of drugs and alcohol, occupational injuries, trauma or crush injuries associated with stampedes, exacerbation of respiratory diseases, and crowd safety. 8 Large MGs can also provide opportunities for terrorist activities. In planning for MGs, international and local health authorities need to ensure that the strengthened public health systems and rapid responses to health risks are integrated with other important components of the overall event management. Eff ective public health policy should be based on evidence. The organisation of international MGs generally requires provision of huge amounts of resources by the host country and the dividend of such high visibility is called legacy. This legacy should be measured not just in terms of absolute improvements (eg, new roads and ambulances) but also in terms of improvements to the public health system and society as a whole. For example, the legacies of strengthened integration of clinical or laboratory services, early warning or syndromic surveillance, and fi eld epidemiology or response adopted for the past summer Olympics (Sydney, Australia, Athens, Greece, and Beijing, China) [9] [10] [11] are used routinely in the health systems. The development of eff ective methods for, and improvement of, planning and handling of the health risks associated with MGs will strengthen global health security, prevent excessive emergency health problems and associated economic loss, and mitigate potential societal disruption in host and home communities. Such development requires credible evidence to support activities that can reduce the global eff ect of infectious diseases and address local public health issues related to morbidity and mortality resulting from noncommunicable diseases during MGs. However, there are gaps in knowledge about many public health issues that contribute to eff ective planning. 6, 12, 13 Therefore, a robust knowledge about illnesses, from basic scientifi c understanding to societal eff ects of infections and noncommunicable diseases, is essential for modern public health practices and policy development related to the planning for MGs. Several reports [11] [12] [13] [14] [15] and WHO planning and guidance documents 1,16-18 have drawn attention to the importance Series of research into public health issues associated with MGs and identifi ed those that need immediate attention. Despite these eff orts, an overarching research agenda based on public health to address the gaps in knowledge in MG health has not yet been developed. Moreover, international coordination to prioritise and enable the funding and implementation of such an agenda has been lacking. The recent recognition and rapid development of MG health can provide focus on such issues. Previously identifi ed research priorities for MGs tended to focus on logistical issues relating to site security and emergency management, crowd control, and surge in the need for medical services. 12, 13 Other specialties tend to focus on each of the specifi c public health topics that are associated with MGs. Much research into existing and emerging infectious diseases is devoted to the development of rapid diagnostic methods, surveillance and response, and treatment and vaccines. Although a research agenda based on public health must be underpinned by basic science, applied science and operational research are areas of particular interest to the organisers of MGs and the decision makers for public health, especially those in poorly resourced countries. The modern day idea of MG health has developed from the notion that "mass gatherings medicine is concerned with the provision of emergency medical care at organized events with >1000 people in attendance" 18 to include several specialties (fi gure). The intricate interactions between the diff erent specialties is essential for the planning and success of MGs. New advances or interventions undertaken in other specialties should be integrated with research into MGs. The proposed research agenda is a broad strategy for research into public health, with a focus on issues related to MGs. It is not intended to be an exhaustive compilation of all possible research questions about the strategic planning for and operation of MGs. Instead the agenda is an outline of key research into methods to control public health and policy. The results of this research can provide an evidence-based platform for policy decisions and practices to reduce the risks and eff ects of MG-associated health issues and global security risks to public health. The principal objectives of this research agenda are to identify topics for research and underpin and prioritise their importance in achieving interventions for the control of public health; provide a research framework to gather evidence to address health issues associated with MGs and global security risks to public health; ensure focus on less well addressed issues such as operational and implementation research, particularly for under-resourced regions; provide a platform to enable co ordination, discussion, and interaction among organisers of MGs, public health professionals, and researchers; and encourage a multidisciplinary approach to address gaps in knowledge about health risks associated with MGs and their control. The proposed research agenda is organised as a framework of fi ve major public health research directions. Although many public health emergencies associated with MGs are not predictable, much can be done to prevent and minimise their eff ects. Continuous monitoring of participants' vulnerability to health risks at MGs and understanding trends in risks that are associated with specifi c events (religious, sports, or concerts) can be used to predict what might happen in the future. They are also essential for successful preparedness and management of risk reduction and strengthening the response capacity of host and home communities. Recognition and analysis of the changing risks and vulnerabilities during MGs are starting points for raising awareness and communication of pending risks. Building global capacity for health intelligence for noncommunicable and infectious diseases is important for the elucidation of the risks associated with MGs. Most of this information is available through networks such as the emerging infectious disease networks 19, 20 and the WHO Global Non communicable Disease Network. 21 Importantly, the information can be used to implement strategies for risk assessment and mitigation in planning for specifi c MGs (panels 1, 2). Morbidity and mortality at MGs can be mitigated through the assessment and management of risks associated with pre-existing non-communicable diseases. Mitigation methods such as the provision of essential drugs and information about their availability at the MG can be initiated during pretravel medical care and advice. 5, 26 Incidence of trauma and heat-related illness at a site can be reduced with the provision of advice and installations to combat the eff ects of weather, and eff ective crowd control. 5 Models for the prediction of the spread of infections and occurrence of other emergency health issues during MGs have yet to be validated. 7 Many of the diffi culties in restricting the spread of emerging communicable diseases [6] [7] [8] 23 are not new and have proven diffi cult to resolve. There is also uncertainty Global clinical and laboratory surveillance systems for communicable diseases, such as those for seasonal and pandemic infl uenza, 22 are well established. The establishment of country-level surveillance systems for infectious diseases that can be adapted to diff erent epidemiological settings for mass gatherings (MGs) could also provide alerts for the occurrence of non-communicable diseases, such as radiation-related or chemical-related illnesses or those caused by extreme environmental temperatures (eg, Program for Monitoring Emerging Diseases). 23 An important component of the alert and response strategy is an integrated event management system that provides a platform for rapid dissemination of devices and procedures required for the management of health risks. Research into their development and implementation is needed. Syndromic surveillance can potentially provide rapid initial information about the occurrence of both non-communicable and infectious diseases. However, its establishment and assessment of eff ectiveness during MGs might require further assessment. Further work is also needed to identify appropriate parameters for assessment of the eff ectiveness of such surveillance systems during MGs. Surveillance of non-communicable diseases is a formidable but necessary step for the improvement of the health of the global community. An estimated 63% of global mortality in 2008 was attributable to non-communicable diseases and 80% of such deaths occurred in low-income and middle-income countries. 24 Age-specifi c and sex-specifi c profi les of non-communicable diseases by country 25 allow host countries of MGs to estimate possible risks of non-communicable diseases in participants from specifi c countries and plan for mitigation strategies. Although the challenges for the organisers of MGs and the eff ects of infectious diseases at such events have been summarised, 6, 14 there are many gaps in our understanding of emerging communicable diseases. Integration of information from local and international surveillance of infectious diseases is important for strengthening the intelligence about the global threats before, during, and after MGs. 23 The risks of non-communicable and infectious diseases during MGs are proportional to the probability of occurrence of risk factors during the event. The identifi cation of these risks factors for the diff erent types of MGs will provide a scientifi c basis for planning eff ective prevention. Although major risk factors associated with non-communicable and communicable diseases are likely to be similar worldwide, factors specifi c to the type of MG might lead to health problems. Systematic risk assessment helps identify potential risks of outbreaks and guides the establishment of eff ective risk management solutions. Systematic assessment will also identify potential or deliberate health security risks that require assistance from other authorities and government agencies. The leading causes of morbidity and mortality during the Hajj are heat-related illnesses and trauma-related injuries. Identifi cation of such risks allowed event planners to instigate preventive measures and rapid response strategies. Provision of shaded areas can reduce the incidence of heat-related illnesses and eff ective crowd control reduces the risk of a stampede. Drug and alcohol use were identifi ed as health risks for other types of MGs; 26 therefore, restriction of their use can mitigate the associated illnesses. The types and magnitude of health risks associated with spontaneous MGs due to natural disasters and confl icts are diff erent from those of organised MGs. Objectives for risk management at such events are focused on facility-based health-care provision in addition to prevention. The potential for importation and subsequent global spread of infectious diseases during MGs are well understood. Many emerging human infections are recognised as zoonotic diseases (eg, severe acute respiratory syndrome [SARS], infl uenza A H5N1, Nipah virus infection). The emergence of novel or rare pathogens in home communities and their subsequent spread to the host community and beyond can be amplifi ed during MGs. Planning for the potential risks and hazards that are associated with MGs is essential to ensure success. Many reports and manuals are available for planning MGs; 1,27-32 however, their use should be tempered by the results of the risk assessment. Importantly, planning should maximise the legacy of the MG. The conceptual model of a lasting public health legacy as a framework for the relation between planning inputs, implementation, and public health outcomes was put forward by WHO and the International Olympic Committee to ensure sustainable, positive health eff ects for the host communities after the Olympic Games. 11 Legacy planning should also include passing the knowledge gained to future hosts of similar MGs. Series about how observations pertaining to particular pathogens, population groups, or settings can be used to develop public health policies for planning diff erent types of MGs. The development of evidence-based strategies for non-pharmaceutical inter ventions is urgently needed to address infection control and mitigate spread in the absence of available drugs and vaccines. Additionally, such strategies are of particular concern for countries that do not have adequate access to pharmaceutical interventions such as vaccines and antimicrobial drugs. In some instances, available data for planning MGs might not have been assimilated in the best way for policy. A balance between basic scientifi c research and operational research is essential to inform the implementation of prevention strategies, best practices, and public health decision making (panel 3). Research into how to contain the spread of infectious diseases should have the broadest possible applicability in diff erent settings and at diff erent resource levels. However, some results might not be generalisable to the planning for MGs, such as those from studies of pathogen transmission in health-care settings. Eff ective management of health risks for noncommunicable and infectious diseases during MGs requires planning in advance. It is an integral part of planning that consists of risk identifi cation, communication, analysis, assessment, prevention, and monitoring. 23, 28, 29 Many of the processes for risk management of non-communicable and infectious diseases during MGs are common. However, each can be specifi c to the type of MG and needs to be addressed accordingly. 8, 26 High visibility of MGs complicates risk management and can lead to political and media pressure and thereby aff ect the decision-making process. Prevention of the occurrence of non-communicable and infectious disease at MGs requires coordinated risk assessment and management before, during, and after the event as shown in the planning for the Hajj. [2] [3] [4] [5] [6] 26 Ideally, the primary prevention of human infections with emerging communicable diseases is the eff ective control of pathogens at their source. Since at-source elimination of all emerging pathogens is not possible, secondary interventions (eg, pharmaceutical or nonpharmaceutical) are needed to mitigate the spread of infection during MGs. However, the eff ectiveness of such interventions has not been established. 33, 34 In addition to reduction of the rates of morbidity and mortality associated with human infections during MGs, reduction of both the circulation of pathogens and human exposure might lessen the global health security risks. The eff ect of emergencies and crises on health can be substantially reduced if home and host communities are well prepared and are able to reduce their risks. The main challenge during MGs is the existence of systematic operative capacities such as risk assessment plans, coordinating mechanisms and standard procedures, institutional capacities, legislation and budgets, skilled Vaccination is highly eff ective in the prevention of infectious diseases. However, many countries, particularly those with insuffi cient resources, have not developed strategies for vaccinating their populations at risk and people travelling to MGs. The reason is partly related to the lack of information about the transmission of infectious diseases (eg, infl uenza) and the social, economic, and health eff ects to the host and home communities. Public health authorities need to decide how to eff ectively prioritise vaccine use on the basis of available information about disease burden and severity, epidemiology, and vaccine eff ectiveness and safety for vaccine-preventable infections associated with MGs. 6 A failure to promote and implement the polio vaccination programme caused the re-emergence of poliovirus in Nigeria and subsequent international spread, 35,36 emphasising the risks associated with insuffi cient vaccine coverage for participants at MGs. An outbreak of Neisseria meningitides serogroup A (originating from Africa) during the Hajj in 1987 37 was later successfully controlled with the introduction of mandatory pretravel vaccination and use of fl uoroquinolones among African pilgrims. 38 However, there are infectious diseases, including some of the most important and most dangerous, for which there are no vaccines. Risk assessment and management during the planning for MGs can enable the development of eff ective health policies. Strategic risk assessments are used to gather, coordinate, and analyse data that are necessary to identify existing risks, anticipate potential diffi culties, establish • Enhance applications of existing vaccines against possible infectious diseases that are associated with MGs • Assess the global vaccine supply and production to improve the processes of rapid response, surge in capacity, and rapid deployment and tracking of vaccine use for planning MGs • Develop innovative clinical trial methods to study the eff ectiveness and safety of novel vaccines before and after licensing • Develop new vaccines, platforms, and formulations that are safe with enhanced immunogenicity, especially in children and elderly people Series priorities, and provide the basis for enacting targeted policies and implementation of corrective interventions. A system is needed for the measurement of the eff ect of public health policy and estimation of the probability of success. These interlinking processes are well described for regularly organised events such as the Hajj and Olympic Games. 5, 11, 14 An example of the eff ective development of health policy is the organisation of the Hajj-such as a smoke-free environment for the prevention of fi re, structural changes to prevent crowding, and recommendations for vaccination of pilgrims to prevent transmission of infectious diseases (eg, infl uenza, meningitis, poliomyelitis). 5 However, such eff ective policies are not possible for spontaneous MGs such as population displacement as a result of natural disasters or confl icts. Development of vaccines for emerging infectious diseases presents substantial challenges and can take many years for diseases that are caused by novel pathogens such as severe acute respiratory syndrome (SARS; panel 4). Even if a vaccine exists, it might need to be regularly updated, clinically assessed for safety and effi cacy, and promptly produced for immediate use (eg, infl uenza vaccines). The effi cacy and eff ectiveness of a vaccine are dependent on the immune responses that are determined by the age of the recipient and composition of the vaccine (eg, conjugated or adjuvanted). Improvements to vaccines and formulations that can provide longer-lasting and broader activity aff ord better protection, increase the applicability of vaccines, and reduce the frequency of vaccination. During an outbreak, the important factors are the rapid production and equitable distribution of vaccines to countries in need. Ensuring rapid and eff ective management of patients and prevention of diseases requires robust health services at MGs. Providers of emergency services play an important part in ensuring public safety during such events. Knowledge and monitoring of medical service provision during MGs has been rapidly increasing in the past decade. 12, 13, 39 However, a lack of consolidated data for diff erent types of MGs means that organisers are not able to plan accordingly for the emergency medical services that might be needed. Improved and targeted clinical management and infection control can substantially reduce the incidence and transmission of infectious diseases during MGs. Optimum clinical management must be based on an improved under standing of the pathogenesis of these infections, advances in laboratory diagnosis, development and application of eff ective antimicrobial drugs, and other treatment modalities (panel 5). There are many gaps in our basic understanding of how many of the pathogens that are associated with MGs cause disease in people and what factors aff ect severity of illness. Host immune responses, underlying comorbidity, age, and the properties of the infecting pathogen can all contribute to severity. The clinical presentation of many infections, such as infl uenza, is not specifi c, which makes diff erential diagnosis and early treatment to reduce further transmission and severe outcomes diffi cult. For example, antibiotics can help control severity and further spread of travellers' diarrhoea caused by bacteria. Rapid and reliable diagnostic testing can expedite the initiation of timely and appropriate treatment and infection control. Increase in and optimisation of the repertoire of antimicrobial drugs immunomodulator drugs, immunoglobulins, and natural products) that are applicable in low-resource areas and in fi eld conditions (such as availability, whether licensed or not, acceptance, and effi cacy in diff erent ethnic, sex, and age groups) and are easy to administer in paediatric-care and emergency-care settings • Optimise management of people who are at risk of severe disease and complications, including emergency-care practices that are applicable across a range of resource settings Health-care capacity and response • Assess the eff ectiveness of global, national, and local responses to outbreaks of communicable diseases and develop new methods for assessment • Undertake operational studies to investigate the surge capacity needs, particularly in host countries for MGs, including development of triage schemes in diff erent health-care and resource settings, and surge planning to maintain adequate resources • Undertake studies to identify evidence-driven clinical-care pathways and principles that optimise health-care delivery in a range of resource settings • Undertake studies to develop principles and practices for rapid assessment and introduction of new interventions during health emergencies, including systems for collation, sharing, and assessment in real time of clinical data Series and development of clinical research to assess effi cacy of putative adjuvant treatments such as immunomodulator drugs, passive immuno therapy, and traditional medicine that are suitable for use in under-resourced areas would be most benefi cial in the preparation for MGs (panel 5). The availability and quality of health services contributes to the eff ect of infectious diseases in the source and home countries (panel 5). The same pathogen that might have a small eff ect on the rates of morbidity and mortality in countries with well organised health-care systems can be devastating in countries where health-care systems are suboptimum. New public health methods need to be harnessed to help reduce the eff ect of health problems during MGs. Use of innovative communication channels, such as the internet and mobile phone networks, have the potential to aid surveillance, rapid risk assessment, and dissemination of accurate information. 23, 40, 41 Mathematical modelling and risk communication have potential applicability in all aspects of research into health risks associated with MGs. Some countries and MG organisers use state-of-the-art approaches for early detection and monitoring of diseases such as syndromic surveillance. 3, 29 In some countries computerised health-care and laboratory-based infor mation systems are used for planning MGs and these systems can be adapted for monitoring large-scale outbreaks. Other innovative technologies such as mobile phones can be used in remote areas or countries that lack the resources to gather and transmit health-related data in real time, provide rapid feedback, and train health-care workers. 7, 23 Applicability and use of these modern methods of monitoring in diff erent settings and contexts require further investigation, with special attention to issues related to integration and interoperability of initiatives for infection control during MGs (panel 6). Evidence-based public health decision making in planning and mitigating health risks requires rapid access to information. However, such information is often incomplete, evolving, and derived from an increasingly complex array of sources such as basic science researchers, epidemiologists, social and political scientists, and economists. Modelling is useful in that it can incorporate diverse data to inform public health policy and decision making. 42, 43 Advances in mathematical modelling for public health are expected to include computational structural biology; integration of epidem iological and geographical data into phylogenetic models; within-host and population-level susceptibility models; behavioural modelling; and assessment of the eff ects of climate change on disease transmission and the use of novel datasets on contact patterns and population mobility. [44] [45] [46] [47] [48] Communication is a key strategy in risk management in planning for MGs. The SARS outbreak in 2003 reinforced the idea that a timely and transparent public information policy could help reduce excessive and inappropriate public health responses and minimise the social disruption and economic consequences of a fast-moving global epidemic. 49, 50 Increased investment in identifying eff ective approaches and developing and assessing new communication methods will benefi t risk prevention and control eff orts. The specifi c challenge is to provide clear, credible, and appropriate communication to meet the needs of diverse communities and retain public trust in a dynamic yet unknown process. 51, 52 Some of the main research topics in this specialty include the link between communication and behaviour change models; development and assessment of methods that can be quickly accessed and used in MGs; and assessment of best practices, challenges, and barriers in risk Research in early detection and monitoring of disease • Identify, develop, and adapt modern technologies for early detection of outbreaks of communicable diseases and their application in disease surveillance during MGs • Integrate and continuously assess innovative approaches and channels for disease surveillance and monitoring • Develop effi cient mechanisms to address the global challenges to sharing information, data, and details about pathogens identifi ed during outbreaks at MGs in terms of local, ethical, legal, and research perspectives • Defi ne the timeliness and quality of data required for early detection of disease from local to district, regional, national, and global levels • Assess the application of modelling to understand and estimate key parameters for risk management • Investigate the role of modelling to assess eff ect of public health policies for diff erent MGs • Assess modelling in public health policy planning and strategic decision making in MG planning Research into health issues related to MGs is at an early stage. Research directions outlined here should contribute to the evidence that can be used to formulate risk management guidelines and assist event planning and health-care policy makers. The research agenda presented here is not intended to be restricted to specifi c aspects of health research but rather to encourage a multidisciplinary approach focused on MG health and to help gain more knowledge. In the future, the focus should be on strategies directed towards developing common research frameworks and defi nitions. Additionally, the knowledge generated by use of the multidisciplinary approach to research ought to be assessed for direct relevance to MGs in terms of their capacity for integration in legacy building and systemic sharing of information. JST wrote the text. MB planned the outline for the review, and provided and consolidated WHO policies and guidelines about MGs. ZAM provided the concept for the review and planned the content with the team. NS provided the outline and wrote the section about risk communication. SB provided information about outbreak control and research agenda for infl uenza. M-PK contributed information about health research directions and vaccine development. All authors reviewed and provided advice on drafting the review. We declare that we have no confl icts of interests. We identifi ed references for this review by searching PubMed, Medline, and the internet for articles published in English from January, 1960, to June, 2011, by using the search terms "mass gatherings", "research", "infectious diseases", "communicable diseases", "non-communicable diseases", "public health", "alert and response", "mass gatherings planning", "legacy", "outbreak", "surveillance", "prevention", "treatment", "Olympic games", and "Hajj". We reviewed the articles and information found during these searches. Additional references cited in the articles were also reviewed. 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