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Emergency Medical Services at the Crossroads 7 Optimizing Prehospital Care Through Research The aim of prehospital emergency medical services (EMS) research is to guide the field with respect to clinical interventions and system designs. Research provides an evidence base to support the application of particular medical treatments and raises red flags when interventions are demonstrated to cause harm to patients. Systems-related research seeks to address operational and structural questions such as the optimum configuration of EMS personnel and the impact of medical direction in EMS systems. Most of the evidence base that exists to support EMS has been generated by researchers at a small number of medical schools, generally in midsized cities, who have ongoing relationships with municipal EMS systems (NHTSA, 1996). The preponderance of published EMS research is component-based, focusing on a single intervention or health problem rather than broader system-level issues. Prehospital EMS research is often categorized under emergency medicine research, which encompasses hospital-based emergency care. Unlike medical research that is defined by specific diseases or organ systems, emergency medicine research is defined by time and place. It addresses conditions and interventions common to the prehospital EMS and hospital emergency department (ED) settings, and its focus is on the acute management of patients. It is often conducted by emergency physicians in collaboration with specialists in other fields, such as pediatrics and cardiology. In addition, there has been a growing contribution to the EMS literature by nonphysicians. Trauma care research is a parallel field of study that is also defined by time and place. Trauma care deals principally with the acute management of patients with traumatic injuries. Like emergency medicine research,
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Emergency Medical Services at the Crossroads trauma care research is concerned with the treatment of these patients in the prehospital and hospital settings, but it reaches further into the inpatient setting, particularly the intensive care unit (ICU) and surgical departments. This chapter focuses primarily on research in the area of prehospital EMS, including prehospital trauma care. Currently, a range of federal government agencies each contribute relatively small amounts of funding to prehospital EMS research. The National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), the National Highway Traffic Safety Administration (NHTSA), the Health Resources and Services Administration (HRSA), and the Centers for Disease Control and Prevention (CDC) all have programs in place to support research in this area. But while the federal government dedicates tens of billions of dollars each year to health-related research, a tiny percentage of that funding is directed to emergency care research in general and prehospital emergency care in particular. The primary foundation-based supporters of emergency care research training are the Emergency Medicine Foundation (EMF), affiliated with the American College of Emergency Physicians (ACEP), and the Society for Academic Emergency Medicine (SAEM). However, both of these programs are quite small, allocating less than $1 million per year combined, and only part of that to EMS. AN INADEQUATE RESEARCH BASE TO SUPPORT EMS Despite the size, scope, sophistication, and critical role of EMS in the United States, the evidence base to support EMS-related clinical and system design decisions is much less well developed than that in other areas of medicine (NHTSA, 1996). Consequently, EMS has for years operated without a sufficient scientific basis to support many of its actions (NHTSA, 2001a; McLean et al., 2002; Sayre et al., 2003). Policy makers and experts in the field have long recognized the paucity of information relating to EMS, and there have been numerous efforts to expand this research base. The 1996 Emergency Medical Services Agenda for the Future, developed by NHTSA’s Office of EMS together with HRSA, focused on the importance of research and evaluation and the need for robust data and information systems (NHTSA, 1996). The 1998 Emergency Medical Services Agenda for the Future: Implementation Guide identified the creation of a national EMS research agenda as a key priority (NHTSA, 1998). The Implementation Guide also stressed the importance of developing academic institutional commitments to EMS-related research and forming collaborative relationships among EMS systems, private foundations, medical schools, and other academic institutions. In 2001, NHTSA and the Maternal and Child Health Bureau within HRSA released the National EMS Research Agenda. The report presented
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Emergency Medical Services at the Crossroads eight recommendations: (1) career EMS investigators should be developed and supported; (2) centers of excellence should be created to facilitate EMS research; (3) federal agencies should commit to supporting EMS research; (4) other public and private institutions should be encouraged to support EMS research; (5) results of this research should be applied by EMS professionals and others; (6) EMS providers should require that evidence be available before implementing new procedures, devices, or drugs; (7) standardized data collection methods should be established; and (8) exceptions from informed consent rules should be adopted (NHTSA, 2001a). The above efforts have helped draw attention to the lack of a research base for EMS and spurred some development in the area. Despite these efforts, however, large gaps in information remain. Patients in the prehospital setting often receive services that have not been proven to work or for which the evidence base is very limited. In many situations, emergency diagnostic and therapeutic strategies have been adapted from patient populations and settings that differ substantially from those of the prehospital environment. Major new programs have been launched with little or no evidence for their cost-effectiveness. Consequently, many treatment strategies employed in the field are of questionable benefit and in some cases may even be harmful. Questions related to core aspects of current clinical practice—for example, the value of field intubation, fluid resuscitation, and advanced life support (ALS) interventions for cardiac arrest—remain unresolved. Rather than being based on scientific evidence, practices are often based on tradition or convention. And because EMS is slow to adopt a current standard of care, the care that is delivered is highly variable. Nonetheless, advancing the science base to determine what constitutes effective care in the prehospital setting would allow for improvements in EMS care over time. Not infrequently, treatments that have established effectiveness and safety profiles when used in hospital- or office-based settings are now implemented in the out-of-hospital setting without adequate examination of patient outcomes. For example, the use of endotracheal intubation to provide ventilation and oxygenation for critically ill or injured children is a well-established and highly effective technique when employed in the relatively controlled environment of the operating room, the pediatric ICU, or even the ED. This technique, however, has been widely incorporated into the practice of paramedics in the out-of-hospital setting without sufficient evidence for its efficacy or safety. Gausche-Hill and colleagues conducted a prospective controlled evaluation of this technique compared with simple bag-valve-mask ventilation to determine its effect on survival and neurological outcomes in critically ill and injured children (Gausche-Hill, 2000; Gausche et al., 2000). The study found no evidence for the benefit of endotracheal intubation in the out-of-hospital setting but did show a substantial incidence of complications. Based on these findings, the Los Angeles and
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Emergency Medical Services at the Crossroads Orange County EMS agencies in California eliminated pediatric intubation from the scope of paramedic practice. To counter the considerable lack of data available to support specific medical interventions conducted in the field by EMS personnel, EMS professionals and policy makers at all levels should work to establish a culture of science-based decision making. In addition to specific clinical interventions, scientific evidence should be used to support systems-level decisions such as the appropriate level of training of responders, the proper deployment of new technologies, the utilization of EMS resources, and the optimal use of medical direction within EMS systems. KEY BARRIERS TO EMS RESEARCH The capacity to investigate key clinical and systems issues in EMS is limited by a variety of factors, including a lack of trained investigators having elected to focus their work on this area of medicine, legal and regulatory barriers that limit the number of qualified research subjects and the sharing of research-related information, and a lack of funding directed specifically to support EMS research. In addition, the infrastructure to support EMS research is lacking in many ways. Existing information systems present a number of problems related to data storage and retrieval (NHTSA, 2001a). For example, data definitions used by different EMS agencies and hospitals often differ, which makes compiling research data more difficult. In addition, most EMS programs continue to use pen-and-paper records, which introduces problems such as illegibility, gaps in information, and estimated data (e.g., time points). This problem may be exacerbated because most EMS personnel in the field do not consider themselves part of the research process and may resent any added paperwork requirements. The move to electronic data collection and more passive forms of data gathering might help alleviate this problem. Even before the enactment of the Health Insurance Portability and Accountability Act (HIPAA; see below), researchers had difficulty in obtaining patient-level data from hospitals and other health care facilities. In general, hospitals have been reluctant to provide such information, in part because of the resources required to organize and collect the data, and more important because of fear of how the information might be used. With or without the restrictions HIPAA places on data sharing, EMS agencies would need to build trust with hospitals to facilitate this type of research work. The complexity of the various agencies and personnel that deliver out-of-hospital care also hinders EMS research. Spaite and colleagues (1995) noted that component research, the cornerstone of “traditional” medical research, is characterized by focused, directed questions, with small numbers of data points that are easily obtained by small numbers of data collectors
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Emergency Medical Services at the Crossroads representing a single agency or institution, working in a tightly controlled environment. The out-of-hospital environment lacks all of these characteristics; rather, it involves complex interrelated questions, with diverse data points collected by many data collectors representing multiple agencies and disciplines in a complex, uncontrolled environment. The authors observed that there are very few examples of successful systems research in EMS, the best of these being the work done on trauma systems (Mullins et al., 1998; Mullins, 1999) and the “chain of survival” concept for out-of-hospital cardiac arrest (Becker and Pepe, 1993; Larsen et al., 1993; Swor et al., 1995). As suggested above, moreover, successful EMS research that has been completed and published in peer-reviewed journals may not be applied in the field until years later. While this problem is not unique to EMS, it presents a significant barrier to ensuring that patients receive prehospital medical services that are supported by a strong evidence base. Accordingly, the National EMS Research Agenda recommended that “EMS professionals of all levels should hold themselves to higher standards of requiring evidence before implementing new procedures, devices, or drugs” (NHTSA, 2001a; Sayre et al., 2002). Limited Research Capacity Research related to EMS is hindered by both the small number of people who decide to pursue such research as a career and institutional factors that limit opportunities for potential EMS researchers. Interest in EMS research and opportunities for formally developing EMS research skills have been promoted in the National EMS Research Agenda and elsewhere (NHTSA, 2001a). Emergency medical technicians (EMTs) and paramedics currently receive little or no formal training in research methodologies, biostatistics, or informed consent and are not instructed in how to perform a critical reading of the literature (Delbridge et al., 1998). A fairly small number of such field personnel have become accomplished EMS researchers (Brown et al., 1996; Lerner et al., 1999; Neely et al., 2000a,b; Brown et al., 2003) by pursuing formal coursework and advanced degrees that were not part of their initial training. A number of EMS physician researchers have backgrounds as field providers, and it appears likely that this experience has contributed to the success and relevance of their projects (Cone and Wydro, 2001; Persse et al., 2003; Key et al., 2003). However, professional training for EMTs and paramedics typically does not encourage future careers in EMS-related research. The National EMS Research Agenda recommended that EMS investigators be developed and supported in the initial stages of their careers and that
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Emergency Medical Services at the Crossroads highly structured training programs with content focused on EMS research methodologies be developed (NHTSA, 2001a). The report noted that many colleges and universities have existing programs that could provide training to interested EMS professionals. For example, graduate degree programs in research and public health could be tailored to meet the specific needs of students with an interest in EMS. The report also supported the development of federally funded research fellowship training programs capable of producing at least five EMS researchers per year. Existing postgraduate fellowships fall into two groups: those that are dedicated research training fellowships and those that are primarily clinical but include a research component. The latter category, which typically includes EMS, is frequently funded by institutional resources and for this reason necessarily includes a substantial patient care component, limiting the fellow’s opportunities to develop research skills. Frequently, this clinical care component provides the financial support for the fellowship. It is generally accepted, however, that a research training program that fails to include 2 years of dedicated research training and at least 80 percent research time is unlikely to result in long-term success in today’s research climate (NIH, 2003). As a result, it is unlikely that postgraduate fellowship programs with a primarily clinical focus are or ever will be an effective tool for improving EMS research capacity. Establishing federally funded fellowship training programs that are research-focused would promote the development of a larger cadre of highly qualified EMS researchers. Regulatory Barriers A number of regulations are in place at the federal and state levels to ensure that patient interests are protected with respect to prospective research work. While these regulations have maintained important patient rights, such as privacy and informed consent, they have also had the effect of reducing the number of patients who participate in research investigations and limiting the ability of researchers to gain access to clinical data. Their ultimate effect is to limit the evidence base available to providers who treat similar patients in the future. Waiver of Informed Consent in Emergency Circumstances The out-of-hospital environment is generally a difficult place to obtain informed consent from patients and/or their families, and EMS personnel typically have no training or experience in doing so (Hsieh et al., 2001; Valenzuela and Copass, 2001; Moscati, 2002). Moreover, patients treated in the emergency and trauma care setting frequently suffer acute, debilitating illnesses or injuries that affect their capacity to make informed deci-
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Emergency Medical Services at the Crossroads sions. Thus, potential research subjects frequently cannot participate in the informed consent process prior to taking part in an interventional clinical trial, even when the therapy being investigated holds the prospect of benefiting them directly. Moreover, it is almost impossible to withhold the current standards of care from potential research subjects even if those standards have not been demonstrated through research to be effective (Spaite et al., 1997). Health Insurance Portability and Accountability Act To investigate patient outcomes resulting from out-of-hospital interventions, it is necessary to obtain outcome information from each of the facilities in which patients were subsequently treated. Out-of-hospital and ED records must be linked with hospital records, vital statistics, and coroner’s records when appropriate. The patient identifiers required to effect such linkages, even when probabilistic record linkage is employed, are subject to the confidentiality provisions of the HIPAA legislation. Because of greater scrutiny of privacy provisions related to HIPAA, it is increasingly difficult for EMS agencies, even when performing quality assurance work, to obtain patient-specific outcome data. Federalwide Assurance Program Another regulatory barrier concerns the Federalwide Assurance (FWA) program. An FWA is an agreement between the federal government, represented by the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (DHHS), and a research organization. The agreement provides assurance that the research organization intends to comply with applicable federal laws and standards for the protection of human research subjects (Newgard and Lewis, 2002). The FWA program, established in 2000, is intended to streamline the previous, more cumbersome system of single-project and multiple-project assurances. An FWA must be in place for an organization to participate in federally funded research that involves human subjects. The FWA regulations have become a significant barrier to obtaining population-based outcome data from patients treated in the emergency and trauma care setting (Newgard and Lewis, 2002). Many patients treated in this 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 usually do not have an FWA in place. Illustrating the problem, Newgard and Lewis (2002) reported difficulties associated with obtaining
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Emergency Medical Services at the Crossroads FWAs with community hospitals to procure patient-level outcome data from a low-risk EMS study. Limited Federal Research Funding The U.S. federal government expends tens of billions of dollars each year on health-related research, including clinical trials and other research examining health care services and treatment guidelines. However, a small share of available research dollars is directed to emergency and trauma care, and even less to prehospital care in particular. This situation has contributed to a dearth of evidence regarding which interventions produce positive outcomes in the prehospital environment. National Institutes of Health 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). NIH includes 20 Institutes, 7 Centers, and 4 Program Offices contained within the Office of the Director. All Institutes but only some of the Centers provide research funding, while several other Centers provide general support (e.g., the Center on Scientific Review). All Institutes and 4 of the Centers receive individual congressional appropriations. The NIH Institutes are organized into five categories: disease, organ system, stage of life, scientific discipline, and profession or technology (IOM, 2003). None of the current Institutes or Centers are defined either by the site of care or the timing or urgency of care, which are the defining characteristics of emergency and trauma care research. NIH does not have an Institute or Center focused specifically on emergency services. Thus, many important emergency care–related clinical questions extend beyond the domains of single NIH Institutes or Centers. Although both a 2003 Institute of Medicine report (IOM, 2003) and the NIH Roadmap Initiative (Zerhouni, 2003) emphasized the importance of stimulating and funding trans-NIH research, the fact that EMS and emergency care research questions naturally span the domains of multiple Institutes and Centers has not been effectively addressed. Agency for Healthcare Research and Quality AHRQ is another federal agency charged with supporting health services research, though on a much smaller scale than NIH. It is estimated that NIH spends approximately $800 million annually on health services research, while the entire AHRQ budget is only approximately $300 million (IOM, 2003).
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Emergency Medical Services at the Crossroads Because funding provided to AHRQ is increasingly tied to specific activities, such as patient safety research, progressively fewer funds have been available for investigator-initiated research and research training. Nonetheless, AHRQ remains a major source of funds for health services and outcomes research, with a specific focus on translating research into practice. The development of methods for effectively translating new research findings into clinical practice is particularly important in emergency care, and it is not surprising that AHRQ has funded a number of important studies in this area, including early research on treatment for cardiac arrest (Eisenberg et al., 1990), studies of first responder defibrillation and prehospital cardiac arrest outcomes in Memphis (Kellermann et al., 1993), and the Pediatric Airway Management project of Gausche-Hill and colleagues mentioned previously (Gausche et al., 2000). National Highway Traffic Safety Administration The Office of EMS within NHTSA plays a lead role in coordinating activities related to EMS system development and research. As mentioned above, the Office of EMS together with HRSA sponsored the development of the National EMS Research Agenda (NHTSA, 2001b). This report highlighted the lack of evidence available to support many clinical practices in the field and detailed an agenda for building the research base. NHTSA’s Office of EMS also currently funds two key research initiatives: the Emergency Medical Services Outcomes Project (EMSOP), a study to develop metrics for use in EMS-related outcomes research (see Box 7-1), and the Emergency Medical Services Cost Analysis Project (EMSCAP), a study to develop metrics for assessing the costs and benefits of EMS. NHTSA and HRSA also cosponsor the National EMS Information System (NEMSIS), the national database on EMS systems and outcomes. NHTSA’s Office of Human-Centered Research sponsors the Crash Injury Research and Engineering Network (CIREN), which collects and shares detailed research data on automobile crashes and patient outcomes (see Box 7-2). Though not specifically research related, NHTSA’s Office of EMS also supports the National EMS Scope of Practice Model project, a joint initiative of the National Association of State EMS Officials and the National Council of State EMS Training Coordinators (see Chapter 4). In addition, the Longitudinal Emergency Medical Technician Attribute and Demographics Study (LEADS) is a project of the National Registry of EMTs partially funded by NHTSA. An annual LEADS survey collects information on the EMS workforce.
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Emergency Medical Services at the Crossroads BOX 7-1 Emergency Medical Services Outcomes Project (EMSOP) EMSOP was designed to develop a foundation and framework for out-of-hospital outcomes research—a branch of clinical research that focuses on determining whether interventions performed in clinical practice actually work (Maio et al., 1999). Given the rate of growth in health care expenditures and the uncertainty regarding the effectiveness of EMS practices, increased emphasis has been placed on demonstrating which clinical interventions can be shown to improve patient outcomes in the out-of-hospital setting (Maio et al., 1999; Spaite et al., 2001). EMSOP resulted in a series of four journal articles outlining the key components of the framework for outcomes research: (1) specific patient conditions that should take precedence in EMS outcomes research; (2) methodologically acceptable outcome models, including the Episode of Care model; (3) core risk-adjustment measures; and (4) specific issues related to pain measurement (Maio et al., 1999, 2002; Spaite et al., 2001; Garrison et al., 2002). BOX 7-2 Crash Injury Research and Engineering Network (CIREN) CIREN is a multicenter research program focused on improving the prevention, treatment, and rehabilitation of motor vehicle crash injuries, with the aim of reducing deaths, disabilities, and economic costs. The program supports a linked computer network of seven level I trauma centers and the collaboration of clinicians and engineers in academia, industry, and government who perform in-depth studies of crashes, injuries, and treatments to improve processes and patient outcomes. The CIREN database, which extends back to 1996, consists of multiple data fields related to severe motor vehicle crashes, including medical injury profiles and crash reconstructions. More than 250 common data elements are standardized across all CIREN sites. Health Resources and Services Administration The Emergency Medical Services for Children (EMS-C) program, jointly funded by HRSA and NHTSA, is one of the largest grant programs supporting EMS research. The EMS-C program also sponsors the Pediatric Emer-
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Emergency Medical Services at the Crossroads BOX 7-3 National EMSC Data Analysis Resource Center (NEDARC) NEDARC is a technical resource for EMS-C grantees and state EMS offices, focused on assisting them in developing their capabilities to collect, analyze, and utilize EMS and other health care data, with the ultimate goal of improving the quality of care provided by state EMS and trauma systems. Established in 1995 through the EMS-C program, NEDARC assists EMS offices in establishing research designs, determining what data to collect, selecting a collection tool, storing the data, overcoming barriers to collection, coordinating data from other systems or agencies, converting data to a standard dictionary, formatting them to conform to a data model, and cleaning or standardizing and aggregating them (NEDARC, 2006). NEDARC also assists in disseminating model data systems from states that have developed such systems. gency Care Applied Research Network (PECARN), the first federally funded multi-institutional network for research in pediatric emergency medicine (PECARN, 2004), as well as the National EMSC Data Analysis Resource Center (NEDARC), which helps states collect and analyze data on pediatric EMS systems and populate the pediatric trauma registry (see Box 7-3). HRSA’s Trauma-EMS Systems Program and Office of Rural Health Policy have also supported research efforts in emergency care. Centers for Disease Control and Prevention The National Center for Injury Prevention and Control (NCIPC) was established at CDC in 1992 as the lead federal agency for injury prevention. Its extramural research program funds and monitors research in all three phases of injury control: prevention, acute care, and rehabilitation. Research supported by the program focuses on the broad-based need to control morbidity, disability, death, and costs associated with injury. CDC’s recently completed Acute Injury Care Research Agenda (CDC, 2005) was developed with extensive input from academic research centers, national nonprofit organizations, and other federal agencies with a stake in injury prevention. The report included seven recommendations for research areas, including the components of trauma systems and disaster preparedness. In addition, CDC’s National Center for Chronic Disease Prevention is funding the Cardiac Arrest Registry to Enhance Survival (CARES) project (discussed in Chapter 3).
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Emergency Medical Services at the Crossroads colleagues (1990) examined rates of survival from out-of-hospital cardiac arrest in 29 cities. The authors found that the chance of survival ranged from 2 percent to more than 25 percent depending on the locality. They concluded that survivability appeared to reflect how rapidly and effectively the system could provide CPR, defibrillation, medication, and intubation, and noted that survival was highest in “double-response” (more often referred to as “two-tiered”) systems in which a first responder EMT arrives to begin CPR, followed by the arrival of a paramedic. Although this appears counterintuitive compared with systems in which all EMS units are staffed by paramedics, the advantage may derive from the fact that a smaller number of paramedic units results in more frequent practice of ALS skills, which may result in better care. Another example is a study conducted by Hunt and colleagues (1995), which showed that on average, the use of lights and sirens saved 43.5 seconds in transporting patients from the scene of an emergency to the hospital, which they concluded was clinically meaningful only in very rare situations. Another systems-related question that has not been adequately addressed by the literature is the impact of medical directors on EMS system performance. Although there is widespread belief in the EMS community that strong medical direction is needed to improve performance, this view has never been conclusively demonstrated. Likewise, data on the cost-effectiveness of specific prehospital medical interventions are almost completely lacking. EXPANDING THE EVIDENCE BASE While prehospital and hospital-based emergency care research focuses on topics of significant public interest and public health importance and has achieved some notable successes, it lacks support within the broader scientific community. As described above, the cross-cutting nature of emergency care means that it overlaps with many other medical disciplines, making it difficult to establish a unique funding home for such research within NIH and other agencies that tend to have a traditional disease or body part orientation. As a result, funding for EMS and emergency and trauma care research is not proportionate to its importance to the nation. Thus there is a need for a broad national commitment to expanding emergency and trauma care research in general and prehospital EMS research in particular. The development of this commitment will require increased recognition of EMS research successes, broader understanding of the need for and value of prehospital EMS research, and enhanced federal support for EMS researchers throughout the relevant federal agencies. The committee recommends that federal agencies that fund emergency and trauma care research target additional funding at prehospital emergency medical services research, with an emphasis on systems and outcomes
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Emergency Medical Services at the Crossroads research (7.1). This increased funding should reflect the benefits likely to accrue from advancing the science of emergency care. Funding devoted to prehospital emergency care research should be aimed at addressing a number of needs that must be met if research in the field is to advance. These include developing a cadre of career researchers, helping to develop routes for prehospital EMS professionals to transition into careers in research, providing research training, funding centers of excellence, and developing multicenter/multisystem research consortiums. For example, a prehospital research network might be established to examine low-volume prehospital events. Meeting each of these needs would develop and strengthen the science base for enhancing the quality, safety, and impact of EMS. With regard to funding, there are critical ties between emergency and trauma care research and disaster preparedness. Because of the current political climate, there is widespread recognition of the importance of improving our understanding of optimal disaster preparedness and management, whether in response to natural or man-made incidents. As discussed in Chapter 6, although current antiterrorism funding is to a large extent focused on combating bioterrorism, the vast majority of terrorist events have involved conventional explosives and nonbiological agents (DePalma et al., 2005). Likewise, natural disasters such as hurricanes and earthquakes continue to occur, and constantly challenge our ability to provide emergency care and effective disaster relief (Schultz et al., 2003). Greater emphasis should be placed on these other, high-probability disaster events, including an increased volume of research supported through disaster preparedness funding. Expanding the Role of Emergency and Trauma Care Researchers in the Grant Review Process One of the greatest impediments to grant funding for emergency and trauma care research at NIH and other agencies is the dearth of researchers in the field involved in developing intramural and extramural research strategies and serving on grant review panels. This is due in part to the cross-cutting nature of the discipline, the relative youth of the field, and the small number of mature investigators. But the exclusion of emergency and trauma care researchers creates a “catch-22”: unless experienced advocates for emergency and trauma care research are involved in the grant development and review processes, junior researchers in the field are unlikely to be successful with their proposals, but without successful proposals, it is unlikely that emergency and trauma care researchers will be asked to participate in the grant development and review processes. While the development of investigators is a critical imperative for the field, the number of mature investiga-
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Emergency Medical Services at the Crossroads tors is growing, and these researchers should be afforded more visibility and authority in grant funding. To address this need, the committee believes that all federal agencies should expand the role of emergency and trauma care researchers in the grant review process. This involvement should encompass any areas of research—including basic, clinical, and systems research—that could have significant application to emergency and trauma care settings, including prehospital, hospital-based emergency, and trauma care. Removing Regulatory Barriers As described above, conducting research in the out-of-hospital environment is unusually challenging. Patients may not be able to make informed consent decisions because they are unconscious or otherwise incapacitated, and paperwork may be prohibitively time-consuming if a patient requires urgent attention. Emergency care already has some flexibility with regard to research, but the rules continue to be problematic in many situations (NHTSA, 2001a). Adherence to federal rules governing the protection of human subjects is ensured by institutional review boards (IRBs). Additional provisions to protect the privacy of human subjects are defined by the HIPAA privacy rule. OHRP is the agency assigned to ensure human subject protections. 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., 2002). Informed consent requirements are important in ensuring that evaluations of new and promising therapies are conducted in an ethical and publicly transparent manner. However, complying with these requirements can be overly burdensome for emergency and trauma care researchers given the condition of many such patients and the circumstances of their treatment (as discussed earlier). 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., 1999; Lewis et al., 2001). Under this exception, some flexibility in the informed consent requirements is allowed in emergency situations, but it remains difficult to comply with the rules in many cases (NHTSA, 2001). As noted by Mann and colleagues (2005), “… 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
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Emergency Medical Services at the Crossroads some of the current obstacles that discourage innovation in treatment approaches with the potential to benefit critically ill or injured patients. In addition, the FWA program was designed to simplify informed consent for research institutions, but sometimes makes it more difficult to conduct emergency and trauma care research that involves nonacademic institutions in the continuum of care. Therefore, the committee recommends that Congress modify Federalwide Assurance program regulations to allow the acquisition of limited, linked, patient outcome data without the existence of a Federalwide Assurance program (7.2). Finally, HIPAA regulations can deter systems research by inhibiting the flow of information across settings—from dispatch to EMS to hospital or trauma center—that constitute an episode of care. To address this issue, specific regulatory language would be required to allow EMS systems or other emergency and trauma care providers to obtain specific outcome data when needed for the assessment of quality of care or effectiveness or for research purposes. Such access would have to be subject to strict confidentiality provisions, with penalties for inappropriate use. The committee therefore believes that Congress and state governments should amend patient confidentiality regulations to allow, under strictly defined circumstances, out-of-hospital and ED records to be linked with longitudinal data on patient outcomes. A working group should be established to consider the specific changes required to address the dampening effect of these regulations on emergency and trauma care research while maintaining their original patient protection goals. Establishing a Research Agenda Until recently, little attention had been paid to the issue of research priorities in EMS. In the past few years, three projects have attempted to disseminate opinions regarding priorities in EMS research. The first, a consensus conference sponsored by the National EMS for Children Resource Alliance, focused on out-of-hospital treatment of children (Seidel et al., 1999). The second was EMSOP, described earlier, which examined needs in EMS outcomes research (Maio et al., 1999). The third is a continuation of the National EMS Research Agenda (Sayre et al., 2002, 2005). In 2002, the National EMS Research Agenda identified the need for a strategic plan for EMS research to concentrate the efforts of EMS researchers, policy makers, and funders, with the ultimate goal of improving clinical outcomes (Sayre et al., 2005). The strategic plan was developed by a multidisciplinary team of EMS personnel, administrators, policy makers, and researchers who participated in a structured consensus-building process. The group has now identified priority topics in EMS research, which include clinical issues in the categories of airway and breathing, cardiovascular dis-
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Emergency Medical Services at the Crossroads ease and stroke, general medical, pediatrics, and trauma, as well as systems and broader medical science issues, including EMS provider education, EMS system design and operation, improving global outcomes, and research and evaluation methods. In addition to these key research areas determined through the strategic planning effort, the committee identified a number of research topics that have not been adequately addressed in the literature to date. These include both clinical and systems issues that are centrally important to the delivery of effective EMS (see Box 7-4). As the largest federal funder of health research, NIH should also take a greater role in facilitating the development of a research agenda for the field. As described above, EMS and emergency and trauma care research is dispersed across many disciplines and funding agencies. The National EMS Research Agenda and other recent efforts have documented evidence gaps and research opportunities across the many fields of emergency and trauma care (NHTSA, 2001a). Except for the recent efforts described above, however, the field has lacked an integrated research strategy prioritizing the critical areas of neglect and establishing a systematic plan for addressing those areas. As a result, NIH and other agencies have continued to pursue a haphazard approach to funding emergency and trauma care research. To address this problem, the committee recommends that the Secretary of the Department of Health and Human Services conduct a study to examine the research gaps and opportunities in emergency and trauma care research, and recommend a strategy for the optimal organization and funding of the research effort. This study should include consideration of the training of new investigators, the development of multicenter research networks, the involvement of emergency medical services researchers in the grant review and research advisory processes, and improved research coordination through a dedicated center or institute. 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 (7.3). SUMMARY OF RECOMMENDATIONS 7.1: Federal agencies that fund emergency and trauma care research should target additional funding at prehospital emergency medical services research, with an emphasis on systems and outcomes research.
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Emergency Medical Services at the Crossroads BOX 7-4 Research Topics Identified by the Committee Clinical Research Impact of prehospital ventilation and intubation on patients with head injuries Identification of the safest and most effective technique for managing respiratory insufficiency in the prehospital setting Testing of the administration of intravenous (IV) fluid to correct hypotension prior to surgery for trauma Performance of newCPR techniques, including chest compression–only CPR Impact on outcomes of performing prehospital 12-lead electrocardiograms (ECGs) for patients with acute (ST) segment elevation myocardial infarction Impact on outcomes of prehospital administration of medications for selected medical conditions (e.g., asthma, congestive heart failure, diabetes, acute myocardial infarction) Systems Research Impact of level of training (e.g., EMT-Basic, EMT-Paramedic) on condition upon arrival and long-term outcome Cost and effectiveness of EMS systems, in particular howthey are impacted by the characteristics of the system Time interval modeling identifying what changes outcomes, and when and where, in the prehospital setting Cost-effectiveness of procedures needed for a range of conditions in a range of settings, including nonemergent care Safety and impact of routing nonemergency 9-1-1 calls to nurse advice lines Safety and impact of treat and release policies versus EMS transport Impact of medical direction on the performance of EMS systems Effectiveness of EMS with respect to injury and acute disease Incremental value of advanced life support over basic techniques in trauma care Effectiveness of newcommunication techniques (e.g., streaming video) and information technology Impact of technology on error reduction or improved decision making (e.g., electronic algorithms, electronic monitor, patient video, and smart implanted chips) Impact of prearrival instructions by dispatchers on the condition of patients upon arrival at the hospital and long-term outcome
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Emergency Medical Services at the Crossroads 7.2: Congress should modify Federalwide Assurance program regulations to allow the acquisition of limited, linked patient outcome data without the existence of a Federalwide Assurance program. 7.3: The Secretary of the Department of Health and Human Services should conduct a study to examine the research gaps and opportunities in emergency and trauma care research, and recommend a strategy for the optimal organization and funding of the research effort. This study should include consideration of the training of new investigators, the development of multicenter research networks, the involvement of emergency medical services researchers in the grant review and research advisory processes, and improved research coordination through a dedicated center or institute. 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. REFERENCES Baren JM, Anicetti JP, Ledesma S, Biros MH, Mahabee-Gittens M, Lewis RJ. 1999. An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent. Academic Emergency Medicine 6(12):1210–1215. Becker LB, Pepe PE. 1993. Ensuring the effectiveness of community-wide emergency cardiac care. Annals of Emergency Medicine 22(2 Pt. 2):354–365. Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. 1995. Informed consent in emergency research. Consensus statement from the coalition conference of acute resuscitation and critical care researchers. Journal of the American Medical Association 273(16):1283–1287. Biros M, Barsan W, Lewis R, Sanders A. 1998. Supporting emergency medicine research: Developing the infrastructure. Academic Emergency Medicine 5(2):177–184. Biros MH, Fish SS, Lewis RJ. 1999. Implementing the Food and Drug Administration’s final rule for waiver of informed consent in certain emergency research circumstances. Academic Emergency Medicine 6(12):1272–1282. Brown LH, Owens CF Jr, March JA, Archino EA. 1996. Does ambulance crew size affect on-scene time or number of prehospital interventions? Prehospital Disaster Medicine 11(3):214–217; discussion 217–218. Brown LH, Bailey LC, Medwick T, Okeke CC, Krumperman K, Tran CD. 2003. Medication storage on US ambulances: A prospective multi-center observational study. Pharmacopeia Forum 29:540–547. CDC (Centers for Disease Control). 2005. Acute Injury Care Research Agenda: Guiding Research for the Future. Atlanta, GA: CDC. Cone DC, Wydro GC. 2001. Can basic life support personnel safely determine that advanced life support is not needed? Prehospital Emergency Care 5(4):360–365. Delbridge TR, Bailey B, Chew JL Jr, Conn AK, Krakeel JJ, Manz D, Miller DR, O’Malley PJ, Ryan SD, Spaite DW, Stewart RD, Suter RE, Wilson EM. 1998. EMS agenda for the future: Where we are … where we want to be. Prehospital Emergency Care 2(1):1–12.
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Representative terms from entire chapter: