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Global Health and Emergency Care: A Resuscitation Research Agenda—Part 2 Marcus Eng Hock Ong, MBBS, MPH, Tom P. Aufderheide, MD, MS, Graham Nichol,MD, MPH, FRCP(C), Bentley J. Bobrow, MD, Leo Bossaert, MD, Peter Cameron, MBBS, MD, Judith Finn, PhD, RN, RM, ICCert, FRCNA, Ian Jacobs, PhD, FRCNA, Rudolph W. Koster, MD, PhD, Bryan McNally, MD, MPH, Yih Yng Ng, MBBS, MPH, MBA, Sang Do Shin, MD, MPH, PhD, George Sopko, MD, MPH, Hideharu Tanaka, MD, PhD, Taku Iwami, MD, PhD, and Mark Hauswald, MD

Abstract At the 2013 Academic Emergency Medicine global health consensus conference, a breakout session to develop a research agenda for resuscitation was held. Two articles are the result of that discussion. This second article addresses data collection, management, and analysis and regionalization of postresuscitation care, resuscitation programs, and research examples around the world and proposes a strategy to strengthen resuscitation research globally. There is a need for reliable global statistics on resuscitation, international standardization of data, and development of an electronic standard for reporting data. Regionalization of postresuscitation care is a priority area for future research. Large resuscitation clinical research networks are feasible and can give valuable data for improvement of service and outcomes. Low-cost models of population-based research, and emphasis on interventional and implementation studies that assess the clinical effects of programs and interventions, are needed to determine the most cost-effective strategies to improve outcomes. The global challenge is how to adapt research findings to a developing world situation to have an effect internationally. ACADEMIC EMERGENCY MEDICINE 2013; 20:1297–1303 © 2013 by the Society for Academic Emergency Medicine

T

he journal Academic Emergency Medicine hosted a global health consensus conference in May 2013, with a breakout session titled

“Global Health: A Resuscitation Research Agenda.” This paper is part 2 of the proceedings from that session.

From the Department of Emergency Medicine, Singapore General Hospital (MEHO, YYN), and the Office of Clinical Sciences, Duke-NUS Graduate Medical School (MEHO), Singapore; the Department of Emergency Medicine, Medical College of Wisconsin (TPA), Milwaukee, WI; the University of Washington-Harborview Center for Prehospital Emergency Care, University of Washington (GN), Seattle, WA; the Department of Emergency Medicine, College of Medicine, University of Arizona, Phoenix Campus, the Maricopa Medical Center, and the Bureau of EMS & Trauma System, Arizona Department of Health Services (BJB), Phoenix, AZ; the Department of Intensive Care, University of Antwerp (LB), Antwerp, Belgium; the Department of Epidemiology and Preventive Medicine, Monash University (PC), Melbourne, Australia; Pre-Hospital, Resuscitation and Emergency Care Research Unit, Faculty of Health Sciences, Curtin University (JF, IJ), Perth, Western Australia; the School of Public Health and Preventive Medicine, Monash University (JF), Melbourne, Australia; the Department of Cardiology, Academic Medical Center, University of Amsterdam (RWK), Amsterdam, Netherlands; the Department of Emergency Medicine, Emory University (BN), Atlanta, GA; the Department of Emergency Medicine, Seoul National University College of Medicine (SDS), Seoul, Republic of Korea; National Heart, Lung, and Blood Institute, National Institutes of Health (GS), Bethesda, MD; the Department of Sport and Medical Science, Kokushikan University (HT), Tokyo, Japan; and the Department of Preventive Services, Kyoto University Health Service (TI), Kyoto, Japan. Received July 15, 2013; revision received August 30, 2013; accepted August 30, 2013. This article reports on a breakout session of the May 2013 Academic Emergency Medicine consensus conference in Atlanta, GA: “Global Health and Emergency Care: A Research Agenda. Breakout session participants: Ryan Arnold, Tom P. Aufderheide, Suzanne Bentley, Connie Boh, Simon Brown, Meena Cherian, Stephen Hargarten, Kate Jacoby, Julianna Jung, Hsuan Lai, Brandon Libby, Bryan McNally, Ka Ming Ngai, Marcus E. H. Ong, Leila Posaw, Jesse Rideout, Joshua C. Ross, Sang Do Shin, and Breena Tiara. The authors have no relevant financial information or potential conflicts of interest to disclose. Supervising Editor: David C. Cone, MD. Address for correspondence and reprints: Marcus Eng Hock Ong, MBBS, MPH; e-mail: [email protected].

© 2013 by the Society for Academic Emergency Medicine doi: 10.1111/acem.12272

ISSN 1069-6563 PII ISSN 1069-6563583

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DATA COLLECTION, MANAGEMENT, AND ANALYSIS Measurement of the incidence, process, and outcome of resuscitation care is a key strategy for improving survival after out-of-hospital cardiac arrest (OHCA) over time.1,2 Lord Kelvin said, “If you cannot measure it, you cannot improve it.” There are significant and important regional variations in the incidence and outcome of OHCA, as noted in part 1 of this report and by Nichol et al.3 These differences are not explained by differences in the distribution of Utstein factors between communities.4 Communities that have used similar methods of episode identification and case definition over time have observed improvements in survival after treatment of OHCA.3,5 There are a host of factors contributing to this variability. These include differences in study design and methods that contribute to variation in estimates of the epidemiology and effectiveness of resuscitation. Measuring the incidence and outcome of OHCA from registries compared to clinical trials offer several advantages, such as the use of simple eligibility criteria to reduce selection bias, limited data collection burden to encourage scalability and sustainability, and large sample size to enable precise estimates of effect. Cardiac arrest registries provide communities with a continuous quality improvement tool, allow for clinical benchmarking of care, and provide research opportunities to further our real-world understanding of OHCA. Registries that reliably capture a defined population (e.g., all emergency medical services [EMS]-treated cardiac arrests) can be used to monitor the incidence of the condition of interest. Retrospective analyses of prospectively collected resuscitation registry data can yield insight into comparisons of different therapies. Potential disadvantages of registries include the presence of unmeasured confounders. Multiple regression can adjust for known confounders, but not for those that are unknown or unmeasured. Clinicians choose specific resuscitation therapies for specific reasons that contribute to selection bias or confounding by indication. Registries must enroll consecutive patients to minimize biases related to assessments of incidence, prognosis, and treatment outcome.6,7 High-quality observational studies should yield estimates of outcome concordant with those of randomized trials.8,9 Registries and trials have been, and will continue to be, complementary to each other.10 Indeed, randomized trials have been implemented as substudies of registries with minimal regulatory and data collection burdens.11,12 Comparing international OHCA rates and outcomes represents a significant challenge. There is a lack of universally agreed-on and applied definitions. The case definition of cardiac arrest may be based on whether EMS providers treat the patient or on the presumed etiology of arrest. Some registries use centralized data collection, some use distributed data collection, and some use electronic data capture. Some registries aggregate missing and not applicable data; some do not. The duration of follow-up varies from one registry to another, with some containing limited hospital outcome data, others including vital status at discharge, and still others following

Ong et al. • RESUSCITATION RESEARCH AGENDA 2

patients to verify vital status at 30 days after the event. In part due to recognition of these variations in implementation of cardiovascular registries, experts have recommended regular auditing and public reporting of the quality of registry data.10 As electronic health records are promulgated, registries that use data from these records should use tools to minimize missing data. An international group is currently updating the Utstein template to develop a common set of definitions to describe the process and outcome of care for patients with OHCA; its publication is set for 2014. Ongoing systematic quality control efforts are necessary to standardize both methods of verification and audit of data submitted to such registries so that comparisons of process and outcome of resuscitation care between communities have both internal and external validity. Few countries have large, comprehensive, ongoing national OHCA registries. Concurrent analyses of partially overlapping data sets from the largest nationwide, prospective, population-based registry to address the effect of epinephrine on outcomes yielded divergent results.13–15 Whether these conflicting results are attributable to differences in enrollment period, inclusion criteria, statistical method, or other factors is unclear. Fortunately, significant progress has been made in how many communities now collect OHCA data. In June 2012, the International Conference on Emergency Medicine in Dublin, Ireland, held a workshop on electronic data capture of OHCA events. Representatives from the following registries presented overviews of their data collection processes while helping to promote the concept of developing a future global electronic standard for OHCA data collection: VACAR (Victoria Cardiac Arrest Registry), Melbourne, Australia; PAROS (Pan Asian Resuscitation Outcome Study), Asia; OHCAR (Out-of-hospital Cardiac Arrest Registry), Ireland; and CARES (Cardiac Arrest Registry to Enhance Survival), United States. CARES and PAROS have been working collaboratively since 2008, adopting a shared taxonomy based on the Utstein style and a uniform reporting process built on a common Web-based software platform. REGIONALIZATION OF RESUSCITATION CARE Trauma. The benefit that trauma systems can bring has been well demonstrated. Early studies clearly showed a major improvement in in-hospital mortality associated with treatment in a major trauma service.16–24 These included qualitative (e.g., preventable death reports) and quantitative studies, with various forms of risk adjustment, most notably using the Trauma and Injury Severity Score methodology, which is based on Abbreviated Injury Scale and Injury Severity Score.25–27 Trauma management is usually according to severity of injury, and severely injured patients would ideally be transported to higher-level hospital where more standardized protocols and definitions are employed. However, the local implementation and optimization of trauma systems is often a political, logistic, and fiscal issue. Research, which by nature often crosses jurisdictions, can yield important data to guide local protocols and policy.

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Comprehensive regionalized collection and linkage of data from prehospital systems with major trauma and community hospitals is feasible and is being undertaken in some jurisdictions.28 However, data on long-term outcomes are still inadequate, especially for the >90% of patients that survive after major trauma. It has been shown that even with relatively basic but standardized interventions, trauma systems will improve survival to close to “best practice.”29,30 However, postdischarge interventions, such as access to compensation, rehabilitation, and the influence of legal settlements may have more significant effects on quality of life and functional outcomes than in-hospital treatment.31 Significant challenges exist in standardizing approaches to injury scoring and coding and outcome assessments (and timing of assessments) other than inhospital fatality32,33 and in managing statistical issues such as managing missing data.34 Cardiac Arrest. For many decades, it was believed that survival from OHCA was based solely on interventions occurring in the prehospital setting.35,36 However, regional variation in mortality after OHCA may also be due to differences in the delivery of in-hospital therapies that improve survival and functional outcome.3 Significant morbidity and mortality after OHCA are due to cerebral and cardiac dysfunction that accompanies whole-body ischemia in what has been termed the post–cardiac arrest syndrome,37 and functional neurologic status after cardiac arrest is strongly influenced by postarrest treatments, despite initial coma after OHCA.38–40 The American Heart Association and ILCOR have published recommendations on postarrest care including implementation and barriers to implementation and guidelines for cardiac resuscitation systems of care.41,42 Unfortunately, a sense of futility frequently impedes continued aggressive in-hospital postresuscitation measures for comatose survivors.43–46 Many medical centers do not consistently provide aggressive, standardized postarrest care.47 To address some of these issues, there have been discussions on establishing cardiac centers equipped and staffed to provide guideline-based, 24/7 post–cardiac arrest and ST-elevation myocardial infarction care. The goal of establishing these centers is to provide potentially life-saving therapies, such as targeted temperature management, percutaneous coronary intervention, and appropriate goal-directed therapies, in a timely manner to as many patients as possible. Each medical center participating in a regionalized cardiac resuscitation system of care should provide timely and standardized data including data linkage of prehospital OHCA event data with in-hospital process and outcome data, to maximize system effectiveness and research capabilities. To achieve this data collection goal in a sustainable way, the number and complexity of data elements must be limited. While the fundamental criterion for these specialized medical centers is the ability to provide targeted temperature management, percutaneous coronary intervention, and high-level critical care, the minimal or optimal size, level of expertise, or patient volume of the medical center have not yet been clearly identified.48,49 An example of a statewide regionalized system of postar-

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rest care was implemented in Arizona in 2007. To date, the Arizona system has collected in-hospital postarrest event data on over 8,500 cases of OHCA. Significant improvements to neurologically intact survival have been measured.50 Is it safe to delay transport to a specialized cardiac center? Work by Spaite et al.,51 the Ontario Prehospital ALS Study (OPALS) registry,52 and the Arizona statewide resuscitation system,53 showed that there was no association between transport time interval and outcome and that bypassing local hospitals in favor of specialized cardiac centers is associated with increased survival. With many of the questions regarding the efficacy and effectiveness of regionalized post–cardiac arrest centers unanswered, we call for urgent, focused research in this area. RESUSCITATION PROGRAMS AND RESEARCH In Data Supplement S1 (available as supporting information in the online version of this paper), we outline a selected sample of multicenter programs of resuscitation research that exemplify the current efforts in addressing knowledge gaps in resuscitation so as to improve survival. Examples include the Resuscitation Outcomes Consortium (ROC),54 PAROS,55 the European Registry of Cardiac Arrest (EuReCA),56 the Australian Resuscitation Outcomes Consortium (Aus-ROC),57 and national cardiac arrest databases such as in Japan,58 South Korea,59 and Singapore60 and CARES in the United States.61,62 These current research examples show that large resuscitation clinical research networks are not only feasible but provide valuable data for improvement of local service and outcomes. They demonstrate that with gathered information, significantly improved resuscitation care is achievable and has potential to substantially affect international public health. CONSENSUS STRATEGY TO STRENGTHEN RESUSCITATION RESEARCH GLOBALLY In Table 1, we list suggested resuscitation research priorities and research questions for the future. Cardiac arrest and life-threatening trauma research is not meant to be taken in isolation, and we need to look at emergency care systems as a whole. On first look it may not appear that those two categories have much in common. The initial pathologic insults and immediate control measures are markedly different. However, the early and timely management in the field by EMS, recognition of metabolic derangements, and management of severe global/regional ischemic insults share common principles. Sharing scientific discoveries and leveraging resources are needed for communities to yield the best care for patients. Another global challenge is how to adapt and apply research findings to a developing world situation to have an effect internationally. Given the enormous public health burden, promise of improved care, and potential to significantly improve survival and public health, significant allocation of resources, including funding for resuscitation research, is warranted. We also need to

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Table 1 Resuscitation Research Agenda for the Future Suggested research priorities 1. Reliable global statistics on resuscitation. 2. International standardization of data collection, endpoints, and reporting standards. 3. An electronic standard for reporting out-of-hospital cardiac arrest, trauma, and other resuscitation related data. 4. Financial support for national databases and registries to document and empower improvements in emergency systems and quality of care. 5. Improve international collaboration, reliability/consistency of data collection, and linkages between data sources. 6. Coordinated monitoring of clinical registries in trauma and OHCA. 7. Focus on regionalization of postresuscitation care. 8. Real-world implementation studies to guide development of regional networks and data regarding clinical and cost-effectiveness. 9. Low-cost models of population-based research. 10. Emphasis on interventional studies and implementation studies that assess the clinical effects of programs/interventions to determine the most cost-effective strategies to improve outcomes, with intact neurologic function. 11. Develop collective research talent and expertise in resuscitation. 12. Implement feasible, efficient, sustainable research infrastructure to collect and link data in different settings, ensure compliance with regulatory issues and to collaborate with officially sponsored public health programs, university-based researchers, and EMS agencies. Suggested research questions 1. What is the “state of resuscitation” globally? 2. Are there disparities in resuscitation outcomes and why? 3. What are the barriers to resuscitation research and is there a better alternative framework for “exception to informed consent”? 4. What are the optimum models for trauma and cardiac arrest care at the regional level? 5. What are the most cost-effective strategies to improve outcomes in low- and middle-income countries? 6. How do we use data to improve local and cross-jurisdictional outcomes in cardiac arrest and trauma? 7. Which data sets provide the most essential information in resuscitation while minimizing workload for operational agencies and consequent data loss? 8. What is the value of dispatcher-assisted CPR, mechanical CPR, ventilation and advanced airway management, adrenaline/ epinephrine, bicarbonate, periarrest hypothermia, extracorporeal membrane oxygenation, and other therapies in the chain of survival (cardiac arrest)? 9. What is the value of airway management, fluid resuscitation, blood products, thromboxane A, progestrogen/estrogens, hypothermia, and other therapies for trauma resuscitation?

address maternal, neonatal, and pediatric resuscitation in low- and middle-income countries in future work. CONCLUSIONS We believe that the way forward includes looking at low-cost, pragmatic models of population-based research, more emphasis on real-world implementation and interventional studies, examining ways to disseminate information to the developing world, and studies that assess the clinical effects of programs and interventions. It also involves finding the most cost-effective strategies to improve outcomes (with intact neurologic function) and to develop research expertise in the field.

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Supporting Information The following supporting information is available in the online version of this paper: Data S1. Resuscitation programs and research.