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Hospital-Based Emergency Care: At the Breaking Point 8 Enhancing the Emergency Care Research Base Emergency care is a broad field of inquiry involving many disciplines and cross-cutting themes. Unlike many other areas of medical research, which tend to be defined by organ systems or types of conditions, emergency care is uniquely defined by the urgency and location of treatment. The emergency care research field has spawned multiple branches, generally defined by specialty or research discipline, that have developed distinct but overlapping identities. The field also extends into disciplines well outside the traditional scope of medical research. Each branch includes basic science, clinical research, and health services research activities. The fact that emergency care research defies easy description has been proven to be one of the principal challenges facing the field as it seeks its niche in the medical research and funding establishment. Figure 8-1 is an attempt to depict the scope of the field and necessarily is an oversimplification; the lines demarcating the three branches tend to suggest stronger distinctions than actually exist. The first branch, emergency medicine research, is defined by time and place. It addresses principally conditions and interventions common to prehospital emergency medical services (EMS) and hospital emergency department (ED) settings, and its focus is on the acute management of patients. The research is conducted by emergency physicians, often in collaboration with specialists in other fields, such as pediatrics or cardiology. Emergency care research also extends significantly into prevention. Trauma research is a parallel field of study that is also defined by time and place. It deals principally with the acute management of patients with traumatic injuries. Like emergency medicine research, it is concerned with
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Hospital-Based Emergency Care: At the Breaking Point FIGURE 8-1 The scope of emergency care research. the care of these patients in the prehospital and hospital settings; however, it reaches further into the inpatient setting, particularly the intensive care unit (ICU) and surgical departments, and deals with critical care and the operative management of trauma patients. In addition to trauma surgeons, the research involves specialists in critical care and anesthesiology, as well as collaborators in organ and disease specialties such as neurology and orthopedics. A significant focus of trauma research is service delivery and the effectiveness of trauma care systems. The injury control field can be thought of as an arm of trauma research that has developed a distinct or rather several distinct areas of focus. It is concerned principally with the prevention of injury, but also overlaps significantly with the acute management of injury and has an additional focus on long-term rehabilitation following traumatic injury. It is one of the most interdisciplinary fields in all of medicine, involving the collaboration
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Hospital-Based Emergency Care: At the Breaking Point of trauma surgeons, numerous medical specialties, engineers, behavioral scientists, and epidemiologists, to name but a few. The third branch represents many other specialties—disease-, organ system–, and population-based—that lack a direct link to the emergency care setting but either independently or through collaboration with emergency medicine researchers make research contributions that impact emergency care. A significant amount of the research effort in both emergency and trauma care involves translation of findings from these fields into practice in emergency care settings. There has also been substantial research in emergency care that has flowed back to the specialties. Finally, nursing research is a growing field that spans all three branches. Its principal focus is the clinical management of patients in all settings. This chapter describes the development and current status of emergency medicine and trauma and injury research, the branches most germane to the present study, with reference to the other specialties as appropriate. The focus is on hospital-based, adult emergency care research; pediatric and prehospital EMS research are addressed in the two companion reports in the Future of Emergency Care series. The chapter also examines barriers to emergency care research and presents the committee’s recommendations for enhancing the emergency care research enterprise. EMERGENCY MEDICINE RESEARCH Emergency care research is vital to the health of Americans. It addresses the care of patients in their most vulnerable moments—when injury or sudden illness strikes. While most Americans have a need for emergency care only rarely, they count on it to be there when needed. Nearly 114 million visits were made to EDs in 2003, and traumatic injury is the leading cause of death among nonelderly adults. In contrast to the vast majority of patient encounters in medicine, the quality and speed of the care that is provided in the relatively brief emergency care encounter can mean the difference between life and death or a prolonged period of disability. Although emergency medicine and trauma surgery are relatively young specialties, researchers have made important contributions to both basic science and clinical practice that have dramatically improved emergency care and resulted in significant advances in general medicine. Examples include assessment and management of cardiac arrest, including the development and refinement of guidelines for cardiopulmonary resuscitation (CPR) and the pharmacology of resuscitation; understanding and treatment of hemorrhagic shock; electrocardiogram (EKG) analysis of ventricular fibrillation; toxicology and detoxification; injury prevention and control; and uses of diagnostic methods and treatment protocols.
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Hospital-Based Emergency Care: At the Breaking Point Emergency Care Research Infrastructure and Funding Because emergency medicine and trauma surgery are young fields, they are not strongly represented in the political infrastructure of the National Institutes of Health (NIH), its various institutes, and its study sections. As a result, scant resources are allocated to advance the science of emergency care, and few training grants are offered to develop researchers who want to focus their work in the field. A conference held in 1994 highlighted the need to strengthen the academic structure and funding for emergency care research (Josiah Macy, Jr. Foundation, 1995). The report resulting from that conference recommended that academic departments in emergency medicine be increased in number and enhanced, and that the specialty develop a research agenda and a strategic plan for its implementation. In response, the specialty took a number of actions to enhance academic departments and develop the capacity and funding of research in emergency care. In 2003, the American College of Emergency Physicians’ (ACEP) Research Committee reported on progress in emergency medicine research (Pollack et al., 2003). Their findings include the following: Academic departments in emergency medicine more than doubled between 1991 and 2001, growing from 18 to 48 percent of medical schools. These increases occurred disproportionately among higher-ranked medical schools. At the time of the study, 63 percent of medical schools had either an academic department or a residency program in the field, and 44 percent had both. Postresidency fellowships in the field increased from 18 in 1988 to 74 in 2002, although only 12 percent of available fellowships had a primary focus on research. By 1999, 54 investigators had been named as principal investigators (PIs) on grants from NIH, the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ), and others. In 2001 there were 40 active grants with emergency-trained PIs, but there are no data on the number of applications rejected. The Emergency Medicine Foundation, a small specialty-supported foundation administered by ACEP, has provided development awards to 89 investigators at 53 academic institutions. However, more than 50 percent of those awards have gone to 12 individuals at 7 institutions. A 2005 report of the ACEP Research Committee noted that emergency medicine residency programs had grown rapidly, from 1 such program in 1970 to 81 in 1990 to 132 in 2005. Currently there are 3,909 emergency medicine residents. The number of federally funded emergency medicine investigators has also increased rapidly but remains low—only 87 in 2005
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Hospital-Based Emergency Care: At the Breaking Point (ACEP Research Committee, 2005). Just 0.05 percent of NIH training grants awarded to medical schools goes to departments of emergency medicine—an average of only $51.66 per graduating resident. In contrast, other medical specialties have much higher levels of support; for example, internal medicine receives approximately $5,000 per graduating resident per year (see Table 8-1). While the pace and quality of emergency care–related research have improved steadily over the last two decades, further progress is limited by several factors. These include (1) a limited number of adequately trained laboratory, clinical, and health services investigators; (2) poorly defined professional research tracks (Stern, 2001; Lewis, 2004); (3) limited interdisciplinary collaboration and multi-institutional research networks; and (4) funding streams that are poorly geared to the nature of emergency care investigations (ACEP Research Committee, 2005). Research Training Support Research training grants and fellowships related to emergency care are funded by a number of sources, including institutions, foundations, and federal agencies. Postgraduate fellowships can be categorized into those that TABLE 8-1 NIH Funding to Medical School Departments for Training Grants in 2003 Field No. of Awards Dollar Amounts Percentage of Total Active Residents/ Fellows NIH Training Grant Dollars per Resident Overall 1,281 370,186,331 100.00 Internal Medicine 354 107,209,870 29.00 21,351 5,021.30 Pathology 78 28,289,147 7.64 2,257 12,533.96 Psychiatry 78 18,176,767 4.91 4,522 4,019.63 Pediatrics 81 17,547,387 4.74 7,773 2,257.48 Surgery 41 8,302,760 2.24 7,623 1,089.17 Neurology 24 5,654,160 1.53 1,339 4,222.67 Ophthalmology 16 3,346,324 0.90 1,260 2,655.81 Anesthesiology 10 2,640,197 0.71 4,719 559.48 Obstetrics/Gynecology 13 2,324,220 0.63 4,681 496.52 Dermatology 13 2,183,009 0.59 994 2,196.19 Otolaryngology 11 1,989,202 0.54 1,071 1,857.33 Urology 9 1,138,828 0.31 1,038 1,097.14 Neurosurgery 2 599,544 0.16 775 773.61 Orthopedics 4 390,055 0.11 3,024 128.99 Emergency Medicine 1 198,012 0.05 3,909 50.66 Family Medicine 0 0 0.00 9,529 0.00 SOURCE: ACEP Research Committee, 2005.
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Hospital-Based Emergency Care: At the Breaking Point are primarily clinical but include a research component (e.g., EMS, pediatric emergency medicine, toxicology) and those that are dedicated to research training. The former category is often funded by institutional resources. Frequently, patient care provides the financial support for the fellowship, limiting the amount of “protected time” trainees have to develop their research careers. It is generally accepted, however, that unless a research training program includes 2 years of dedicated research training (e.g., greater than 80 percent research time), it is unlikely to result in long-term success in today’s research climate (NIH, 2003). Thus postgraduate fellowship programs that are supported by clinical activity are unlikely to be an effective means of improving the nation’s research capacity in emergency care. A substantial number of institutions offer dedicated postgraduate research fellowships, which may be funded using institutional resources, may be contingent on the individual applicant’s securing extramural funding, or may be funded by extramural support to the institution through an Institutional (T32) Grant. Currently, there is only one emergency care–related institutional training program supported by the T32 mechanism, and its focus is pediatric emergency medicine. No Institutional or Career Development (K12) Grant has ever been awarded directly to an academic department of emergency medicine (ACEP Research Committee, 2005), although some departments may have submitted grant applications under the name of the academic medical center hospital rather than the medical school. The primary foundation-based supporters of emergency care research training are the Emergency Medicine Foundation (EMF), affiliated with ACEP, and the Society for Academic Emergency Medicine (SAEM). Both entities fund individual research fellowships for trainees who have completed residency training in emergency medicine, or in the case of SAEM, in pediatrics with the intent to pursue pediatric emergency medicine fellowship training. Currently, the EMF fellowship grants supply only a single year of training, although 2-year fellowships may be added. The SAEM individual research training grants provide 2 years of training. SAEM also funds an institutional training grant, through which 2 years of support is provided to the institution with the intent that the institution will then recruit an appropriate trainee. This funding mechanism was explicitly modeled after the T32 mechanism. A handful of emergency care research trainees have secured individual NIH F32 National Research Service Award (NRSA) fellowship funding. Further, a notable number of emergency care researchers have obtained support for career development and educational activities through the K08 and K23 mechanisms (ACEP Research Committee, 2005). As detailed in the 2005 ACEP report (ACEP Research Committee, 2005), a substantial proportion of all emergency medicine trainees intend to pursue an academic career, yet paradoxically, the support devoted to
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Hospital-Based Emergency Care: At the Breaking Point emergency care research and research training is very low, especially compared with other medical specialties. While existing foundation support has modestly increased the number of well-trained emergency care investigators, substantial growth in the total available research training support will be required to expand the emergency care research capability nationwide. Many have noted a concerning lack of young investigators, both in industry-sponsored clinical trials and among the ranks of federally supported clinical investigators. Sung and colleagues (2003, p. 1282) reported that “8 percent of principal investigators conducting industry-sponsored clinical trials are younger than forty years,” and “less than 4 percent of competing research grants awarded by the National Institutes of Health (NIH) in 2001 were awarded to investigators aged thirty-five years or younger” (see also Zisson, 2001; Goldman and Marshall, 2002). By contrast, investigators in emergency care specialties, including emergency medicine, pediatric emergency medicine, and EMS, are characterized by their relative youth. Physician-scientists in these fields are generally recently trained, and with the receipt of additional clinical research training may be well positioned to initiate productive, long-term clinical research careers. In its 2005 report, ACEP called for the development of 100 new investigators within 10 years through the NIH Mentored Career Development Award Program (K12) at an estimated cost of $50 million over 10 years. Sung and colleagues (2003, p. 1283) recommended that, as part of a strategy to increase the number of well-trained clinical investigators, academic health centers and research sponsors, including federal sponsors, “increase opportunities for training in all areas of clinical research, including health services and outcomes research, clinical trials, and research synthesis, and develop a mechanism for collecting longitudinal data on training program outcomes.” Similarly, many have noted the lack of a sufficient pool of well-trained laboratory and patient-oriented investigators in emergency care. Nevertheless, emergency medicine investigators have made important contributions in laboratory investigations of shock, ischemia–reperfusion, cellular injury, early biomarkers for cardiac ischemia, cerebral resuscitation, and neuro-protection. For many years, medical training in the specialties of emergency medicine, pediatric emergency medicine, and trauma surgery were heavily focused on the development of clinical skills, with little formal training in research methodology. As noted by Stern (2001), formal fellowship training is now a well-recognized requirement for those embarking on a successful long-term research-based academic career. To address the shortage of training for new investigators in emergency medicine, the committee recommends that academic medical centers support emergency and trauma care research by providing research time and adequate facilities for promising emergency care and trauma investigators, and by strongly considering the establishment of autonomous departments of emergency medicine (8.1).
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Hospital-Based Emergency Care: At the Breaking Point Research Funding A 1994 review of nonmilitary research articles published in three emergency medicine journals revealed that the majority of articles did not list a source of funding. This is in contrast to other specialties, in which the majority of published research was funded. The literature review also found that funded studies published in the emergency medicine literature were less likely to be federally supported and more likely to be supported by industrial sources relative to studies published in the literature of other specialties (Wright and Wrenn, 1994). Although these results may be dated, federal funding, and in particular NIH funding, remains difficult for emergency medicine researchers to obtain (Morris and Manning, 2004). The limited amount of funding available for emergency care research extends across a wide range of institutes, programs, and sponsors, although NIH remains the key sponsor. As noted earlier, because of the cross-cutting nature of emergency care, the field overlaps with many other medical disciplines. This makes it difficult to establish a unique funding home for emergency care within NIH and other research sponsors that tend to have a traditional orientation based on diseases or body parts. On the other hand, the cross-cutting nature of emergency care exposes it to many opportunities for collaboration with other research specialties and disciplines, and collaborating with established researchers in other fields may be a good way for emergency care investigators to obtain or expand their research funding. National Institutes of Health NIH includes 20 institutes, seven centers, and four program offices contained within the Office of the Director (OD). NIH is the largest single source of support for biomedical research in the world, with a budget of over $27 billion in 2004 (IOM, 2004). All institutes but only some of the centers (e.g., the Center on Scientific Review [CSR]) provide research funding, while several other centers provide general support. All institutes and four of the centers receive individual congressional appropriations. The NIH institutes are organized into five categories, some by disease (e.g., the National Institute of Neurological Disorders and Stroke [NINDS]), some by organ system (e.g., the National Heart, Lung and Blood Institute [NHLBI]), some by stage of life (e.g., the National Institute of Child Health and Human Development [NICHD]), some by scientific discipline (e.g., the National Human Genome Research Institute [NHGRI]), and some by profession or technology (e.g., the National Institute of Nursing Research [NINR] and the National Institute of Biomedical Imaging and Bioengineering [NIBIB]) (IOM, 2003). None of the current institutes or centers is defined either by the site of care or the timing or urgency of care—defining characteristics of emergency care research. Perhaps for this
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Hospital-Based Emergency Care: At the Breaking Point reason, NIH does not have an institute or center focused specifically on emergency services. Thus, many important emergency care clinical questions extend beyond the domains of single NIH institutes or centers. While both a 2003 Institute of Medicine (IOM) report (IOM, 2003) and the NIH Roadmap Initiative (Zerhouni, 2003) emphasized the importance of stimulating and funding trans-NIH research, and emergency care research questions naturally span the domains of multiple institutes and centers, the lack of attention to emergency care has not been effectively addressed. In fact, the term “emergency care” does not appear in the NIH Roadmap. Other federal agencies Many other federal agencies provide small amounts of research funding in emergency care. AHRQ, for example, like NIH, does not have a dedicated funding stream for research on emergency services. However, it does have a long track record of funding grants in emergency care, such as a study on the effects of cost sharing on use of the ED, evaluation of technologies for identifying acute cardiac ischemia in EDs, and measurement of ED crowding (AHRQ, 2004). The Health Resources and Services Administration (HRSA), through its Emergency Medical Services for Children (EMS-C) Program, sponsors the Pediatric Emergency Care Applied Research Network (PECARN), the first federally funded multi-institutional network for research in pediatric emergency medicine. The EMS-C Program also sponsors the National EMS Data Analysis Resource Center (NEDARC), which was established in 1995 to help states collect and analyze data on pediatric EMS systems and to populate the pediatric trauma registry. The HRSA Trauma-EMS Systems Program and the Office of Rural Health Policy also support research efforts in emergency care. CDC’s National Center for Injury Prevention and Control (NCIPC) sponsors investigations in injury prevention and control and recently developed an Acute Care Research Agenda for the Future. NCIPC/CDC and the Consumer Product Safety Commission cosponsor the National Electronic Injury Surveillance System (NEISS), a longitudinal database with information from 100 hospital EDs on consumer product–related injuries, and since 2000 on all injuries. NCIPC also sponsors the Data Elements for Emergency Department Systems (DEEDS) project, a national effort to develop uniform specifications for data entered in ED patient records. The Office of EMS in the National Highway Traffic Safety Administration (NHTSA) plays a lead role in coordinating activities related to EMS system development and research. Together with HRSA, NHTSA sponsored the development of the National Emergency Medical Services Research Agenda (NHTSA, 2001). The Office currently funds two key research initiatives: the Emergency Medical Services Outcomes Project, a study to develop metrics for use in EMS-related outcomes research, and the Emer-
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Hospital-Based Emergency Care: At the Breaking Point gency Medical Services Cost Analysis Project, a study to develop metrics for assessing the costs and benefits of EMS. NHTSA and HRSA cosponsor the National EMS Information System (NEMSIS), a national database on EMS systems and outcomes that is operated by the National Association of State EMS Directors. NHTSA’s Office of Human-Centered Research sponsors the Crash Injury Research and Engineering Network (CIREN), a network of level I trauma centers that collect and share detailed research data on automobile crashes, injuries, and outcomes. Although not research funding per se, funds are being provided by NHTSA’s Office of EMS for the National EMS Scope of Practice Model project, a joint initiative of the National Association of State EMS Directors and the National Council of State EMS Training Coordinators. The Longitudinal Emergency Medical Technician Attribute and Demographics Study (LEADS) is a NHTSA-funded project of the National Registry of Emergency Medical Technicians. An annual LEADS survey collects information on the EMS workforce. The Centers for Medicare and Medicaid Services (CMS), the Department of Homeland Security, and the Department of Veterans’ Affairs also provide small amounts of funding related to emergency care research. Private Funders SAEM and EMF both provide investigator training grants, as described earlier. EMF awarded 18 grants in 2004–2005 totaling almost $500,000 (Pollack and Cairns, 1999; ACEP, 2005). The Robert Wood Johnson Foundation funded the Urgent Matters project, which provided grants to 10 hospitals and their communities for evaluating approaches to reducing crowding and improving patient flow. A small number of emergency medicine researchers received research training through The Robert Wood Johnson Clinical Scholars program. The National Emergency Medicine Association also provides research grants in trauma and emergency care. Future Directions in Emergency Care Research Pressing gaps remain in our understanding of emergency care in all three research areas: basic science, clinical research, and health services research. There have been several recent attempts to identify research priorities and key opportunities in emergency care (Aghababian et al., 1996; Maio et al., 1999; Seidel et al., 1999; Becker et al., 2002). The EMS Research Agenda for the Future project (Sayre et al., 2005) identified priority issues for targeted research efforts, including asthma, acute cardiac ischemia, circulatory shock, major injury, pain, acute stroke, and traumatic brain injury, as well as education and system design issues. Critical research questions identified
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Hospital-Based Emergency Care: At the Breaking Point by these groups cut across basic science, clinical research, and health services research. Some fertile topics for research in each area are described below. Basic Science Because emergency medicine is defined by time and place, rather than body part or disease process, research in the field is often mischaracterized as being strictly translational in nature. But emergency medicine requires both basic discoveries and translation of those discoveries to the clinical setting. Basic research projects involving emergency medicine investigators focus on the following: Characterization of the molecular events that cause delayed neuronal death after brain ischemia and other studies on neuronal injury (multiple NINDS grants). The pathophysiology of carbon monoxide poisoning and mechanisms for the benefit of hyperbaric oxygen therapy (multiple NIH grants). Understanding of the events that occur following ischemia–reperfusion injury from cardiac arrest, using animal models, cardiomyocyte cell culture models, and methods for inducing hypothermia for treatment of patients following cardiac arrest (NIH). The pathophysiology of acute lung injury and acute respiratory failure (NHLBI). Means of minimizing the risk of secondary ischemic brain injury during limited resuscitation from hemorrhagic shock and traumatic brain injury (Department of Defense [DoD]). Identification of effective neuroprotective agents to limit tissue loss and enhance recovery following acute traumatic brain injury or stroke (NINDS, CDC). Pathophysiology and treatment of traumatic spinal cord injury (NIH). Hypothermia and gene expression following cardiac arrest (NIH). Pathophysiological processes that contribute to the destruction of articular cartilage in a variety of disorders, including an evaluation of immunoprobes for lubricin from human synovial fluid (NIH). Understanding of the human genomic and proteomic response to injury and injury recovery. Clinical Research Because of the wide range of patients, diseases, and interventions seen by physicians in emergency practice, these practitioners have a unique window on the state of treatment options available, including their shortcomings.
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Hospital-Based Emergency Care: At the Breaking Point Current and Future Research Directions Current directions in trauma and injury research have been the subject of several recent reports. The NIH and DoD Working Group on Trauma Research Program was convened in 2003 and developed a report that identified and summarized current trauma research priorities (Hoyt et al., 2004). It identified priorities in three key areas: basic science, clinical trials, and clinical research. In basic sciences, it identified cellular injury (immune response following injury), bleeding and thrombosis, central nervous system injuries, and multiple organ failure. Areas in need of clinical trials to establish efficacy included airway management, fluid resuscitation, therapies for controlling bleeding, adjuvants to control postinjury immune response, and body temperature management. The three top areas for clinical research were physiological monitoring, automated clinical data collection, and development of large-scale longitudinal datasets for research. The report cited the continuing lack of an organized infrastructure as an impediment to progress in resolving a number of key issues and addressed ways to build this infrastructure for resuscitation research, including development of a consistent informed consent process (for multicenter trials), formation of an animal model consortium, increased use of multicenter trials, centralized tissue banks, and standardized data collection and analysis. In 2002, NCIPC developed a research agenda that addressed the following broad injury categories: injuries at home, sports, transportation, domestic violence, suicide, youth violence, acute care, disability, and rehabilitation. The agenda also identified four cross-cutting research priorities: translating research into programs and policies, improving parenting and controlling alcohol abuse, identifying the costs and consequences of injury, and building the research infrastructure. In 2005, CDC updated the acute care chapter of the 2002 agenda. This revision identified seven research priorities: Better translation of findings into patient care through guidelines Evidence-based protocols How trauma systems improve care How mass casualty impacts acute care Clinical prevention Psychosocial impact of injury Development of short- and long-term outcome measures The report also called for enhancing research capacity through four actions: the development of acute care injury research networks; the conduct of research by mining current and future databases; the development of new investigators though training grants; and reductions in institutional barriers to research, such as Emergency Medical Treatment and Active Labor Act
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Hospital-Based Emergency Care: At the Breaking Point (EMTALA) regulations. Finally, the report noted the need for more research on morbidity and disability outcomes (National Center for Injury Prevention and Control, 2005). BARRIERS TO EMERGENCY CARE RESEARCH There are unique logistical problems associated with conducting emergency care research, such as lack of a coordinating funding structure; the difficulty of establishing informed consent in emergency care situations; and the challenge of linking medical records to reconstruct an episode of care across prehospital, ED, and inpatient settings. Organization and Funding of Emergency Care Research Taken as a whole, the emergency care research enterprise has accomplished a great deal. Many of these accomplishments have been made with bootstrap funding and by poorly supported researchers in a disconnected fashion. But the field has reached a level of maturity that requires a new approach. There are well-defined areas of critical inquiry that require a coordinated and well-funded approach. In addition, there is a crucial need for an integrated research effort across disease lines that breaks down departments and requires multidisciplinary approaches to achieve effective translational research. This effort must include a wide range of disciplinary strengths—from epidemiology, pathophysiology, and toxicology to surgery, psychology, and biomechanics—to integrate the wide range of interrelated medical and sociological issues faced by the modern ED. It should be clear that the current uncoordinated approach to organizing and funding emergency and trauma care is ineffective. Therefore, the committee recommends that the Secretary of the Department of Health and Human Services conduct a study to examine the gaps and opportunities in emergency and trauma care research, and recommend a strategy for the optimal organization and funding of the research effort (8.2). This study should include consideration of training of new investigators, development of multicenter research networks, funding of General Clinical Research Centers that specifically include an emergency and trauma care component, involvement of emergency and trauma care researchers in the grant review and research advisory processes, and improved research coordination through a dedicated center or institute (8.2a). Congress and federal agencies involved in emergency and trauma care research (including the Department of Transportation, the Department of Health and Human Services, the Department of Homeland Security, and the Department of Defense) should implement the study’s recommendations (8.2b). This study should encompass the broad range of emergency care research, including emergency medicine, trauma, and injury and basic,
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Hospital-Based Emergency Care: At the Breaking Point science, clinical research and health services research, and should consider ways to enhance the coordination of emergency care research across topics, disciplines, and agencies. The inclusion of emergency care researchers on advisory and review committees has special merit in the committee’s view. NIH, for example, uses a wide variety of advisory committees: (1) initial review groups (IRGs, also known as study sections) and special emphasis panels (SEPs), (2) national advisory councils, (3) boards of scientific counselors, and (4) program advisory committees. The IRGs and SEPs perform the first level of peer review, scoring grant applications on technical and scientific merit. The national advisory councils perform a second level of peer review, providing advice to the institute or center both on the funding of individual applications and on more general issues related to the mission and goals of the institute or center. The combined review by the IRGs/SEPs and the national advisory councils is commonly termed the “dual review system” (IOM, 2003). The boards of scientific counselors perform retrospective reviews of intramural research programs and are not discussed further here. The program advisory committees provide input on research programs, future research directions, and the development of extramural research initiatives (IOM, 2003). The vast majority of members of advisory committees are appointed by either the NIH director or the directors of the individual institutes or centers. Emergency care providers often have a unique perspective on the evaluation and management of specific syndromes and diseases, as they routinely manage the most acute and extreme manifestations of those conditions and must often act decisively with only preliminary clinical information. Thus, emergency care providers can provide important complementary perspectives during the framing of clinical research questions to be addressed by interdisciplinary clinical research teams and during the evaluation of research applications and proposals. These perspectives can be particularly valuable for judging proposals that require the timely recruitment of research subjects in acute care situations and for addressing the logistical challenges of conducting well-controlled clinical research in EDs, trauma centers, and other acute care environments. General Clinical Research Centers (GCRCs) play a critical role in supporting the clinical research enterprise and serving as a fertile ground for the development and training of young clinical investigators. There are currently 87 GCRCs supported by the National Center for Research Resources, which include both inpatient facilities and ambulatory research clinics associated with academic health centers. These facilities are potentially valuable in providing mentorship to new clinical investigators and junior faculty and in facilitating the enrollment of subjects into clinical research studies. However, GCRCs rarely if ever support clinical research conducted in the ED, much less in out-of-hospital settings. Thus, emergency care investigators have
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Hospital-Based Emergency Care: At the Breaking Point not had access to an important national resource. One reason is that most GCRCs are funded to conduct scheduled clinical research protocols. They are not well staffed, if staffed at all, to conduct emergency and trauma care research on a full-time basis. While it would be neither feasible nor perhaps prudent to staff all GCRCs in this way, a subset of GCRCs, particularly those based in hospitals with a major ED and level I trauma center, might be encouraged to compete for supplemental awards to support time-critical clinical trials on resuscitation and trauma care research.3 Protection of Human Research Subjects Federal rules govern the protection of human research subjects, and these rules are enforced by institutional review boards (IRBs). Additional rules to protect the privacy of human subjects are defined in the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). The Office for Human Research Protections (OHRP) within the Department of Health and Human Services is the agency assigned to enforce protections for human subjects. The rules attempt to balance the value of important research against the potential harm to patients resulting from that research. Some have argued that the current rules overly restrict critically important research, particularly in emergency and trauma care (Newgard et al., 2005). Informed consent requirements represent an important tool for evaluating new and promising therapies in an ethical and publicly transparent manner; however, complying with the requirements can be overly burdensome for emergency care researchers. Patients treated in the emergency care setting frequently have suffered acute, debilitating illnesses or injuries (e.g., cardiac arrest, traumatic brain injury) that affect their capacity to make informed decisions. Thus, potential research subjects often cannot participate in the informed consent process before participating in an interventional clinical trial, even when the investigational therapy offers the prospect of direct benefit to the individual subject. It is also difficult to secure informed consent because care must often be administered immediately. Currently, federal regulations (21 Code of Federal Regulations §50.24) allow a narrow exception to the general requirement for prospective, written informed consent for participation in research studies in the setting of an acute, debilitating illness or injury for which there is no accepted effective therapy (Biros et al., 1995, 1998, 1999; Baren et al., 1999; Sloan et al., 1999b; Lewis et al., 2001). Under this exception, however, it remains difficult to comply with the rules in many situations (NHTSA, 2001). As noted by Mann and colleagues 3 Under the NIH’s Roadmap Initiative, Clinical Translational Science Awards (CTSAs) are replacing GCRCs as the principal mechanism for supporting institutional clinical research. The Committee’s concerns about support for emergency care also apply to CTSAs.
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Hospital-Based Emergency Care: At the Breaking Point (2005, p. 1078), “…the logistical application of these ethical standards across institutions or among different research studies remains complex and variable.” Furthermore, state regulations occasionally preempt the federal exception for emergency care research. Active guidance from OHRP to states and individual IRBs could eliminate some of the current obstacles that discourage innovation in treatment approaches of potential benefit to critically ill or injured patients. The committee therefore recommends that states ease their restrictions on informed consent to match federal law (8.3). Patient Confidentiality Protection Under new rules established in 2000, all entities participating in federally funded research must obtain a federalwide assurance (FWA) from OHRP. The FWA is a document that ensures the intent of the research organization to comply with applicable federal laws and standards for the protection of human research subjects. The FWA program was intended to streamline the previous, more cumbersome system of single- and multiple-project assurances. But many patients seen in the emergency care setting, either those initially treated by EMS or those treated in community EDs, produce important health care utilization and outcome data that are stored at nonacademic community-based medical facilities. These facilities are unlikely to participate in federally supported research in general and therefore generally do not have an FWA in place. Newgard and colleagues (2005) examined the difficulties associated with effecting FWA agreements with community hospitals to obtain patient-level outcome data from a low-risk EMS study. The study involved an attempt to validate a triage rule for children seriously injured during automobile crashes through a retrospective chart review of cases at 27 pediatric receiving hospitals in Los Angeles County. The researchers were unable to achieve participation from all 27 hospitals, which they attributed to the complexity and risk of the FWA requirement. All 27 hospitals had agreed to participate in an interventional randomized controlled trial of airway management in children several years earlier, before the FWA requirement was in place (Gausche, 2000). To have robust and generalizable results, it is important to include outcome information from the full range of receiving facilities to which the EMS system delivers patients. The NIH Roadmap itself cites the need to remove barriers to collaborative clinical research between community-based providers and academic researchers (Zerhouni, 2003). In addition, there is limited guidance regarding FWAs in EMS research. In the Field Administration of Stroke Therapy–Magnesium (FAST–MAG) trial, a $16 million NIH grant, investigators had to seek help from OHRP. It was finally decided that hospitals had to either have an FWA, apply to have an FWA, or use an academic medical center as a “parent FWA” and sign
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Hospital-Based Emergency Care: At the Breaking Point a written agreement with the parent for their IRB to ensure protection of human subjects. Further, all of the 41 EMS agencies in Los Angeles County had to sign an agreement with the Los Angeles EMS Agency to allow the agency to serve as their FWA and oversee protection of human subjects. While for the most part successful, this effort has taken 2 years. To make it possible to conduct important emergency care research on representative populations in the community, the committee recommends that Congress modify Federalwide Assurance Program regulations to allow the acquisition of limited, linked, patient outcomes data without the existence of a Federalwide Assurance Program (8.4). One approach that has been suggested is to allow an experienced academic medical center IRB to serve as a regional IRB for community hospitals within a certain area, at least for minimum-risk research (Christian et al., 2002; Newgard et al., 2005). SUMMARY OF RECOMMENDATIONS 8.1: Academic medical centers should support emergency and trauma care research by providing research time and adequate facilities for promising emergency care and trauma investigators, and by strongly considering the establishment of autonomous departments of emergency medicine. 8.2: The Secretary of the Department of Health and Human Services should conduct a study to examine the gaps and opportunities in emergency and trauma care research, and recommend a strategy for the optimal organization and funding of the research effort. 8.2a: This study should include consideration of training of new investigators, development of multicenter research networks, funding of General Clinical Research Centers that specifically include an emergency and trauma care component, involvement of emergency and trauma care researchers in the grant review and research advisory processes, and improved research coordination through a dedicated center or institute. 8.2b: Congress and federal agencies involved in emergency and trauma care research (including the Department of Transportation, the Department of Health and Human Services, the Department of Homeland Security, and the Department of Defense) should implement the study’s recommendations. 8.3: States should ease their restrictions on informed consent to match federal law.
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Representative terms from entire chapter: