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Emergency Care for Children: Growing Pains 7 Building the Evidence Base for Pediatric Emergency Care Pediatric emergency care is a young field. Even in the late 1970s, there were no pediatric emergency medicine textbooks or journals (Ludwig, 2001). Considerable progress has been made since that time, and these advances should be applauded. However, the advancement of knowledge in pediatric emergency care must not slow. Indeed, many unanswered questions remain about the best way to organize and deliver such care. The committee decided to devote an entire chapter to research because of its great potential to improve the quality, organization, and delivery of pediatric emergency care. The payoff from increased pediatric emergency care research, while difficult to quantify, will include lives saved, decreased morbidity, and a more efficient and effective emergency care system. The chapter begins with a review of pediatric emergency care research from the 1980s through the present day and continues with a discussion of why advancing the state of knowledge remains critical today. It then turns to some of the barriers to pediatric emergency care research that hinder progress and presents the committee’s recommendations for overcoming those barriers. EARLY DEVELOPMENT OF PEDIATRIC EMERGENCY CARE RESEARCH As noted in Chapter 2, attention to deficiencies in the pediatric emergency care system grew in the 1980s, and as a result, a variety of organizations began to take action. A number of studies were published that provided information on the demographic characteristics of children who were us-
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Emergency Care for Children: Growing Pains ing emergency services, the kinds of illnesses and injuries with which they presented, and the readiness of providers to care for them. These studies were generally single-site research projects initiated at children’s hospitals, medical schools, and/or local departments of health. For example, published research described the epidemiology of cardiac arrest and resuscitation in children in suburban King County, Washington (Eisenberg et al., 1983); pediatric emergencies in Minneapolis, Minnesota; and pediatric versus adult death rates in the field in Los Angeles County (Seidel et al., 1984). Emerging information on pediatric injuries and illnesses and early indications of inadequacies in the capacity of the emergency care system to address pediatric needs played a large part in the U.S. government’s decision to create the Emergency Medical Services for Children (EMS-C) program in 1984. EMS-C was among the first government programs to support the collection of data on pediatric emergency care. Its early activities included collecting data on pediatric emergencies to assess the need for specialized pediatric programs. Some of the major pediatric emergency care research published in the late 1980s continued to show shortcomings in the emergency care system for children (Seidel, 1986a,b; Seidel et al., 1991), including differences in deaths rates for children in rural versus urban settings (Gausche et al., 1989a,b). There were also studies that focused on ways to improve the system for children, such as creation of a specialized pediatric emergency care system in Los Angeles (Henderson, 1988); creation of a new tool, the Broselow tape, for estimating pediatric weight and drug dosages (Lubitz et al., 1988); and development of an accurate pediatric trauma score (Ramenofsky et al., 1988). The 1993 Institute of Medicine (IOM) Report Emergency Medical Services for Children called attention to the need for pediatric emergency care research by highlighting knowledge gaps in the field. These gaps encompassed the most basic questions about emergency care services for children: What is the structure of the system? Who uses the system? For what is the system used? What services or procedures are provided to patients? When are services provided? What are the outcomes of using the system? What are the global costs of the system? How well does the system perform? The report noted that “research is needed to validate the clinical merit of care that is given, to identify better kinds of care, to devise better ways to
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Emergency Care for Children: Growing Pains deliver that care, and to understand the costs and benefits of the [emergency care system] now in place and toward which the nation should move” (IOM, 1993, p.16). The report contained a research agenda and called for the development of a uniform dataset that would be used by states to collect, analyze, and report data to EMS; include all elements of a national uniform dataset; describe the nature of EMS provided to children; and link data generated by separate components of EMS (IOM, 1993). After the report’s release, the EMS-C program established the National EMS Data Analysis Resource Center (NEDARC) to help grantees and state EMS offices develop capabilities to collect, analyze, and utilize EMS and other data to improve the delivery of emergency and trauma care. Specifically, NEDARC staff provide research design consultation, information on data collection (e.g., which elements to collect, hardware/software issues, confidentiality issues), information on statistics, general analysis of data, and probabilistic linkage (MCHB, 2004a). Also in the 1990s, the first infrastructure for multicenter pediatric emergency care research was established when the American Academy of Pediatrics’ Section on Emergency Medicine created the Pediatric Emergency Medicine Collaborative Research Committee (PEM CRC). The infrastructure of PEM CRC is privately funded and has served as the platform for many research projects, the majority of which have been clinical (PECARN, 2003; AAP, 2005). At least seven studies supported by the collaborative were published between 1994 and 2004 (AAP, 2005). Perhaps the most significant development in pediatric emergency care research occurred when the EMS-C program created the Pediatric Emergency Care Applied Research Network (PECARN)—a collaborative research group consisting of hospital emergency departments (EDs) organized into nodes, with central coordination from a steering committee (PECARN, 2003, 2005). PECARN is focused on the conduct of multicenter, randomized trials and observational studies on a variety of pediatric emergency care issues. There are four Regional Node Centers, each of which coordinates five or six Hospital Emergency Department Affiliates. The strength of PECARN lies in the annual number of patient encounters it covers—900,000 ill and injured children (PECARN, 2006). Additionally, the research involves senior-level pediatric emergency medicine researchers and clinicians with expertise in epidemiology, statistics, and health services research. While PECARN is still young, it appears to hold significant promise for advancing research in pediatric emergency care. A research agenda specific to multi-institutional studies is being developed by the PECARN steering committee and will be available in late 2006 (Personal communication, D. Kavanaugh, May 10, 2006). An important shortcoming of PECARN, however, is that it has con-
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Emergency Care for Children: Growing Pains ducted little research in the prehospital environment. The one exception is a current study on cervical spine injury, addressing the immobilization practices of prehospital providers. The study involves focus groups of prehospital providers to evaluate their opinions on immobilization practices and their willingness to participate in research evaluating those practices retrospectively. PECARN recently established an out-of-hospital working group to develop EMS research ideas. However, research in prehospital pediatric emergency care has lagged far behind that in ED-based pediatric emergency care, both within PECARN and in other research efforts. Data indicate that the volume of research in pediatric emergency care has grown considerably. Spandorfer and colleagues (2003) reviewed abstracts on pediatric emergency medicine research submitted to national scientific meetings of the American Psychological Association (APA), American College of Emergency Physicians (ACEP), American Academy of Pediatrics (AAP), and Society for Academic Emergency Medicine (SAEM) and found that there had been a substantial increase in such research between 1987 and 1999. There had also been an increase in the number of population-based and multicenter clinical trials in the field. Additionally, the number of trials that were randomized and blinded had grown over time, although they still represented just 7 percent of pediatric emergency care studies published during the period. The design of studies had varied little between 1987 and 1999; there had been no increase in the proportion of studies that were prospective or used an analytic design (Spandorfer et al., 2003). However, the use of more sophisticated statistics had become more prevalent over time. Between 1993 and 2002, five journals published slightly more than half of the published articles related to pediatric emergency care: Pediatric Emergency Care, Pediatrics, Annals of Emergency Medicine, Pediatric Clinics of North America, and Archives of Pediatrics and Adolescent Medicine (Gough et al., 2004). CONTINUED NEED FOR RESEARCH Although the amount of research conducted in pediatric emergency care has increased considerably over the past 25 years, significant information gaps remains. Indeed, the gaps that exist today include many of the broad, systems-level questions identified as research priorities in the 1993 IOM report on emergency care for children. Additionally, many new, unanswered questions have emerged in the last 10 years as our understanding of the determinants of quality care delivery has improved. This section reviews progress made toward addressing the information gaps that existed in 1993 and identifies some other areas in which research could contribute to improved care. Finally, it presents the rationale for devoting resources to addressing the information gaps that persist today.
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Emergency Care for Children: Growing Pains Progress Toward Closing the Information Gaps Identified in 1993 Despite the increase in research activity and funding since 1993, the questions about pediatric emergency care posed in the 1993 IOM report remain not only salient, but also largely unanswered. What is the structure of the system? There is no central resource containing reliable information on the number and characteristics of the facilities, emergency care providers, and services available in the emergency care system. However, different organizations that represent emergency providers collect some basic information. For example, the American Hospital Association keeps a tally of the total number of EDs in the country, and the National Association of Children’s Hospitals and Related Institutions keeps a list of the number of children’s hospitals. Additionally, we have a general idea from surveys of the percentage of EMS agencies that are fire department–based versus stand-alone. However, this information is only the first step in understanding the structure of the emergency care system. Information on the capabilities and services available from each provider remains elusive, as does information on how the structure varies within and across states and regions. Who uses the system?, For what is the system used?, What services or procedures are provided to patients?, and When are services provided? We are able to answer all of these questions today with regard to children’s use of EDs; however, these questions remain unanswered with respect to those using the prehospital (EMS) system. One important source of information on ED utilization is the federal National Hospital Ambulatory Medical Care Survey (NHAMCS), which has collected nationally representative information on ED visits since 1992. NHAMCS allows researchers to study the use of EDs by patient characteristics including age, race, and insurance status. The data also include the reason for the visit and the triage category (for example, immediate, urgent, nonurgent); the physician’s diagnosis for each patient, as well as the diagnostic, screening, surgical, counseling, educational, and therapy services provided during the visit; and when patients arrived at the ED, how long they waited, and when they left. Another important data source is the State Emergency Department Databases (SEDD), part of the Healthcare Cost and Utilization Project (HCUP) sponsored by the Agency for Healthcare Research and Quality (AHRQ). The SEDD captures information on all ED visits that do not require admission and allows for the analysis of data at the state or, in many cases, the county level. The SEDD contains more than 100 clinical and nonclinical variables, including diagnoses, procedures, patient demographics, expected payer source, charges, hospital identifiers, and county identifiers. As of September 2005, 17 states were participating, and data from many of those states are available for the years 1999 to 2004 (AHRQ, 2005). In contrast to these in-hospital data systems, data collection on the
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Emergency Care for Children: Growing Pains use of EMS has progressed slowly. At the local level, most data on EMS are collected on paper, although many systems are beginning to transition to electronic systems. Because EMS information systems are produced by a variety of vendors and each state defines its own data elements, there is little uniformity or consistency of data collection across agencies (Mears, 2005). As a result, a national database on EMS utilization does not exist, although one is in development. The National Highway Traffic Safety Administration’s (NHTSA) Emergency Medical Services Agenda for the Future described five goals for an EMS information system: (1) adopt uniform data elements and definitions, and incorporate them into information systems; (2) develop mechanisms for generating and transmitting data that are valid, reliable, and accurate; (3) develop information systems that are able to describe an entire EMS event; (4) develop integrated information systems with other health care providers, public safety agencies, and community resources; and (5) provide feedback to those who generate data (NHTSA, 1996). Efforts are under way to achieve each of these goals through the National EMS Information System (NEMSIS). NEMSIS is geared toward improving data standardization and linking disparate EMS databases at the federal, state, and local levels (Mears et al., 2002). It will serve as a national EMS database that can be used to evaluate patient and EMS system outcomes, benchmark performance, facilitate research efforts, develop nationwide EMS training curricula, determine national fee schedules, and address issues related to disaster preparedness resources. NEMSIS will be able to supply information at the national level, such as the total number and types of EMS calls, average response times, and the most widely used medications and procedures. Currently, 48 states (excluding New York and Vermont) have elected to participate in the program. By the end of 2006, 6–7 states are expected to be fully operational in the program and will be submitting state-level data; by the end of 2007, an additional 17 states are expected to be doing so. Becoming fully operational means that states are collecting and submitting NEMSIS-compliant data from their individual EMS agencies. What are the outcomes of using the system? Information on outcomes from the emergency care system is limited. Process outcomes, such as hospital admission or referral to a tertiary care facility, are important to understanding how patients move through the system. Some limited data are available on ED patients through NHAMCS, which contains information on the patients’ disposition, including whether they were admitted to the hospital, the intensive care unit/critical care unit, or an observation unit. However, NHAMCS does not include data on hospital outcomes. Combining SEDD data with another data source within HCUP allows researchers to determine the percentage of patients who are admitted and the inpatient treatments received.
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Emergency Care for Children: Growing Pains A great hindrance to addressing questions about outcomes is that many data systems cannot be linked. In other words, once a child’s parents contact 9-1-1, a first-responding fire engine may arrive, and the child may be transported by EMS and delivered to a hospital ED, but information on the patient beyond each point in the hand-off is rarely available to those involved earlier in the chain of events. The absence of uniform incident numbers and other methods of achieving data linkage hinder researchers in gathering information on clinical outcomes, which is often of greater importance than measures of the processes of care. Clinical outcomes, based on hospital disposition, functional status at discharge, patient well-being, morbidity, and mortality are often available only when specifically studied by a supported research initiative, such as PECARN. Still, our knowledge of optimal treatment patterns for many pediatric interventions is limited, while such information for the prehospital environment is even less obtainable. What are the global costs of the system? The global costs of the emergency care system for children are unknown. The direct and indirect economic costs of operating a pediatric emergency care system, as well as the monetary savings that could be realized over time through the successful expansion of initiatives to improve pediatric emergency care, are of key interest, but few studies have explored such questions (DHHS et al., 1997). How well does the system perform? Information on the performance of the pediatric emergency care system is limited. Performance measurement for emergency care services has received growing attention, but as yet there are few opportunities for researchers to gather information on system performance at the local or state level, much less nationally. The Growing Information Gap Considerably more is known about pediatric emergency care than was the case in 1993, but the information gaps in the field have widened as more areas of importance have been identified. The quality framework developed by the IOM in Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001) is now widely used to evaluate the adequacy and safety of health care delivery. In Chapter 2, this framework was used to provide an overview of the state of pediatric emergency care under the current system. As explained in this chapter, however, the information necessary to fully evaluate the pediatric emergency care system is lacking. The information gaps of today include the following questions: How safe is pediatric emergency care? How often do medical errors occur? How often are patients harmed from the receipt of emergency care services? Which aspects of pediatric emergency care are least safe? Which aspects are most safe?
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Emergency Care for Children: Growing Pains How effective is pediatric emergency care? How much care being delivered is not supported by evidence? In what areas of pediatric emergency care is evidence most lacking? How patient-centered is pediatric emergency care? How often do providers consider the wishes of patients and their families in treatment decisions? What percentage of EMS agencies and hospitals have patient-centered policies? What percentage of EDs have a patient-centered environment? How often are parents/guardians satisfied with the emergency care provided to their children? How timely is pediatric emergency care? How long do pediatric patients wait for prehospital services? How quickly are they transported to EDs? How efficient is pediatric emergency care? Is pediatric emergency care cost-effective? How often is ineffective care delivered? How much waste exists in the emergency care system? What is the value of that waste? How equitable is pediatric emergency care? How do the availability and quality of care delivered vary based on patients’ gender, age, race, ethnicity, income, education, geographic location, and/or disability? Three Types of Research Pressing gaps remain in our understanding of emergency care with respect to all three types of research: basic, translational, and health services. 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 is aimed at increasing fundamental understanding of a subject. It typically involves study of anatomy, physiology, cells, molecules, and genes. Basic science investigations do not immediately provide results that are relevant for the delivery of emergency care, but they lead to a better understanding of diseases and provide knowledge that eventually helps in finding new ways to diagnose, treat, and prevent various types of illnesses or injuries. An example is recent studies demonstrating the detrimental effect of brain injury on an animal’s ability to compensate for hemorrhage (Lewelt et al., 1980, 1982; Ishige et al., 1987, 1988; Yuan and Wade, 1991; Yuan et al., 1991; DeWitt et al., 1992a,b; Fulton et al., 1993). These findings have, at least in part, laid the foundation for some of the current guidelines of the Brain Trauma Foundation. Basic research projects in pediatric emergency medicine could address the pathophysiology of acute respiratory failure, ways to minimize the risk of secondary ischemic brain injury during limited resuscitation from hemorrhagic shock and traumatic brain injury, and the pathophysiology and treatment of traumatic spinal cord injury.
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Emergency Care for Children: Growing Pains Translational research is the most active area of emergency care research because of the wide range of patients, diseases, and interventions seen by EMTs and physicians in emergency practice. These providers are afforded a unique window on the state of available treatment options, including their shortcomings, and therefore have both the motivation and opportunity for focused efforts to translate research into better modes of treatment. An example is recent translational work by Sanders and others that investigated alternative cardiopulmonary resuscitation (CPR) techniques to determine the optimal ratio of chest compressions to ventilations (Berg et al., 1995, 1997, 2001; Kern et al., 2002; Sanders et al., 2002). The data from these studies demonstrated improved neurological outcomes with a higher ratio of chest compressions to ventilations (100:2) as compared with standard CPR (compression:ventilation ratio of 15:2). These data, as well as other observations, led to changes in the American Heart Association’s guidelines for CPR. At the same time, it has been noted that the U.S. health care system has a poor record in incorporating demonstrated effective and safe therapies into routine clinical practice (Lenfant, 2003). With increasing recognition that simply establishing the safety and efficacy of a new therapy is insufficient to ensure its widespread use, many institutes within the National Institutes of Health (NIH), as well as AHRQ (which leads these efforts), have increasingly emphasized the importance of translating research into practice. This is an important area that deserves special emphasis within emergency care research as well. Examples of pediatric translational research include the formulation of guidelines for the efficacy, safety, and dosage of medications for infants, children, and adolescents; the development of evidenced-based protocols for the treatment of common pediatric conditions (e.g., fever); assessment of the effectiveness of new interventions, such as ultrasonography, needleless drug administration, and innovations in procedural sedation; and evaluation of the pharmacokinetics and efficacy of promising clinical therapies for treating pediatric acute traumatic brain injury. Emergency medicine by definition requires timely and efficient approaches to the delivery of services. The organization and mode of delivery have long been recognized as having major impacts on the quality and outcomes of care. But the organization and delivery of services is perhaps the weakest link in the emergency care evidence base. Even established doctrine, such as the value of paramedics in the field, has recently been overturned. This, then, represents a formative and essential area for health services research. Some of the key research questions in the delivery of pediatric health services include the feasibility and cost-effectiveness of implementing mental health or child abuse screening of pediatric patients in the ED; the causes and solutions for missed diagnosis in the ED; identification of
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Emergency Care for Children: Growing Pains which components of pediatric trauma systems impact outcomes and cost-effectiveness; and the impacts of ED crowding, boarding, and diversion on pediatric patients. Health Promotion and Injury Prevention Injury prevention is important for all age groups but particularly for children, whose unique needs must be taken into account (see Box 7-1) (IOM, 1985). Injury not only is the leading cause of death for children, accounting for more deaths among those aged 1–18 than all other causes combined, but also is responsible for more years of potential life lost than any other health problem (Baker et al., 1992). Injuries are the most common cause of pediatric ED visits as well (McCaig and Ly, 2002). Although emergency care providers are not commonly linked to public health prevention activities, their potential role in such efforts has been recognized (Maclean, BOX 7-1 Airbags and Children Just as new medical technologies and information systems must be designed with pediatric patients in mind, prevention efforts must consider the potential implications for children. Passenger side airbags are an example of a prevention device designed for adults that resulted in unintended harm to child passengers. Since the early 1970s, airbags, in concert with seat belts, have saved thousands of lives (McCaffrey et al., 1999). Because of their potential to reduce the burden of injury in a crash, dual air bags were required as standard equipment in all cars and light trucks in the United States in the late 1990s. However, many children—as many as 35 percent of child passengers in the 1990s—ride unrestrained in automobiles (National Center for Statistics and Analysis and NHTSA, 2005). As the number of vehicles equipped with dual air bags increased, federal regulators noted a sharp increase in the number of fatal injuries to children resulting from airbag deployment. Many of these injuries stemmed from children being unrestrained or improperly restrained, but a small number occurred to children who were properly restrained in the front seat (CDC, 1996). Because airbags must deploy at the moment of impact to catch an unrestrained passenger, they literally explode open, fully inflating within milliseconds. The speed of airbag deployment can exceed 140 to 200 miles per
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Emergency Care for Children: Growing Pains 1993). Patient encounters with EMS and ED providers offer a unique opportunity for preventive education. NHTSA’s 1996 Emergency Medical Services Agenda for the Future emphasized the importance of engaging EMS systems in injury and illness prevention programs designed to address regional needs (NHTSA, 1996). ED providers have similarly been encouraged to play a key role in injury control and prevention (DHHS et al., 2000; Mace et al., 2001; ACEP, 2002). While emergency providers’ historical role in prevention has focused on surveillance and research, they also play a small but growing part in delivering preventive care and education. In fact, in 49 states and territories, emergency care personnel are utilized for injury prevention activities (MCHB, 2004b). The benefits of such activities (decreased health care consumption, reduced costs, lower morbidity and mortality) have been well established for certain prevention strategies; however, the extent to which prevention activities carried out by emergency care providers reduce the hour. Children placed in the front passenger seat are at much higher risk for being harmed by airbag deployment than adults for several reasons: they are more likely to be moving around or leaning forward in their seat, even if restrained; children placed in the front seat in a forward-facing child restraint are several inches closer to the airbag than adults; children may shift closer to the airbag during precrash braking because their feet do not touch the floor, so they cannot brace themselves; a child’s head and neck are more likely to be struck by the deploying airbag; and most important, infants placed in the front seat in a rear-facing child safety seat are inadvertently within striking distance of the airbag. After reviewing the early pediatric injury and fatality data for airbags, the National Transportation Safety Board released a number of recommendations regarding the safe transport of children in automobiles with airbags. For example, infants should ride in rear-facing child safety seats in the back seat. Children under age 12 should be properly secured in the back seat as well. For older children, shoulder belts should not be worn behind the back or under the arm. Additionally, the vehicle seat should be set as far back as possible (CDC, 1996). Additionally, the National Highway Traffic Safety Administration enacted regulatory measures to address the problem, including labeling requirements for vehicles and child safety seats and specifications for airbag cutoff switches (CDC, 1995). In 2002, the American Academy of Pediatrics issued guidelines for counseling parents about the most appropriate child safety seats and positioning of child passengers (AAP, 2002).
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Emergency Care for Children: Growing Pains included in the networks allows researchers to carry out trials designed to evaluate rare conditions or complications. There are a number of primary care research networks in existence. For example, the AAP established the Pediatric Research in Office Settings (PROS) Network in 1986. The mission of this network is to improve the health of children and enhance primary care practice by conducting national collaborative practice-based research. In 2004, the network included more than 1,900 practitioners from over 700 offices in the 50 states, Canada, and Puerto Rico. The network is currently working on a variety of projects, including studies on how practitioners diagnose child abuse in primary care settings, on a new way to help parents prevent child violence, and on how to improve practice/clinic immunization rates. The Vermont Oxford Network (VON), founded in 1988, includes more than 485 neonatal intensive care units in the United States and other countries. It maintains a database that provides unique, reliable, and confidential data to participating units for use in quality management, process improvement, internal audit, and peer review. The network disseminates the results of its research in medical journals and through a network publication. The National Cancer Institute at NIH also has a pediatric research network—the Children’s Oncology Group (COG)—which was established in 2000. COG is a clinical trials cooperative group devoted exclusively to childhood and adolescent cancer research. It develops and coordinates clinical cancer trials conducted at its 238 member institutions in the United States, Canada, Europe, and Australia. COG members include more than 5,000 cancer researchers. There are also several research networks focused on general aspects of emergency medicine. For example, Emergency ID Net is a CDC-funded, interdisciplinary, multicenter, ED-based network for research on emerging infectious diseases, established in cooperation with CDC’s National Center for Infectious Diseases. The network is based at 11 university-affiliated urban hospital EDs with a combined annual patient visit census of more than 900,000 (Talan et al., 1998). The Emergency Medicine Network’s Multi-Center Airway Research Collaborative (MARC) performs long-term research on airway disorders, including asthma, chronic obstructive pulmonary disease, anaphylaxis, pneumonia, and bronchiolitis. Many of the studies investigate both adults and children. The Emergency Medicine Cardiac Research and Education Group International, an industry-sponsored group centered in Cincinnati, Ohio, was established in 1989 to conduct multicenter clinical trials on serum markers for the early diagnosis of acute myocardial infarction. Since its inception, the network has grown from 18 researchers in 15 institutions to 44 researchers in 31 academic facilities worldwide. These collaboratives have a well-defined group leadership, such as a steering committee or board of directors; have produced multiple publications; and in many cases have received funding support from di-
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Emergency Care for Children: Growing Pains verse sources, including government, private foundations, and industry. In addition, they tend to perform education and service functions along with research (Pollack et al., 2003). PECARN is the only research network focused specifically on pediatric emergency care. It includes four regional nodes with 21 hospitals serving approximately 900,000 pediatric patients a year (PECARN, 2006). Since being established, PECARN has completed a major core data project, and several other projects have been federally funded for the evaluation of such issues as the efficacy of dexamethasone in the treatment of bronchiolitis, the factors that can contribute to a decision rule for the evaluation and treatment of minor head injuries in children, the use of lorazepam for treatment of seizures in children, and cervical spine injuries in children. An important attribute of these research networks is that they establish an infrastructure for research in a particular area. If they receive the funding needed for sustainability, they not only generate important findings in the field, but also help train and support the development of young investigators. Recognizing the importance of research networks to the knowledge base and the research infrastructure, the committee formulated recommendation 7.1—that the Secretary of Health and Human Services conduct a study to examine research gaps and opportunities in emergency care, including pediatric emergency care, encompassing a focused look at the development of multicenter research networks. Ideally, such networks should address issues including prevention, trauma, and pediatric emergency medicine. In particular, research networks such as PECARN should expand their research into the prehospital environment. Research networks generally should work toward expanding to more hospitals so their findings can be more representative of the care that is delivered nationally. For example, PECARN represents children’s hospitals disproportionately to the volume of care these hospitals provide to pediatric emergency care patients nationally. Since children’s hospitals tend to have more pediatric resources than other hospitals, certain findings from PECARN may not be reflective of the care provided at community hospitals nationally. One of the challenges to expanding PECARN beyond children’s hospitals is that community hospitals often lack the infrastructure and resources to conduct clinical research. The professional reward structures in community hospitals often are not aligned with the commitment of large amounts of time and effort to research. PECARN and other research networks will have to be creative in achieving representation of the many children who receive care in community hospital EDs. As PECARN tries to expand its reach, network leaders should also consider how pediatric surgeons, health services researchers, and public health researchers might be better integrated into the network to expand the scope of research generated. The committee’s call for the development and enhancement of multi-
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Emergency Care for Children: Growing Pains center research networks is not new. In fact, at both the 1995 Emergency Medicine Research Directors Conference and the 1997 Future of Emergency Medicine Research Conference, participants encouraged the growth of such networks (Pollack et al., 2003). Trauma Registries Injury is the leading cause of death and disability in children beyond the first year of life. The optimal clinical management of pediatric injuries may differ significantly from that of similar injuries in adults. Despite the prevalence of pediatric trauma, many unanswered questions remain about optimal care for certain subsets of pediatric trauma patients. Trauma registries, used to collect, store, and retrieve data on trauma patients, could help in deriving answers to some of these questions by allowing researchers to study etiological factors, demographic characteristics, diagnoses, treatments, and clinical outcomes of pediatric patients. Registries could be used to evaluate and improve the quality of care, compare patient outcomes across providers, identify hazardous environments (e.g., dangerous intersections or devices), identify injury trends, prioritize and evaluate public health interventions, provide data for benchmarking and improvement purposes, and monitor trends in trauma systems (HRSA, 2005). Trauma registries are expensive to develop and maintain, but they are effective in decreasing morbidity and mortality (Shapiro et al., 1994). There have been a number of different initiatives aimed at developing trauma registries. Today, 37 states maintain such a registry; these efforts have been supported by grant funding from HRSA’s Trauma-EMS Systems Program, which was recently defunded (HRSA, 2005). This situation represents an improvement over that in 1992, when only 24 states operated trauma registries (Shapiro et al., 1994). State trauma registries collect pediatric-specific data; however, they have a number of shortcomings. They are not standardized nationally or even statewide in some cases. They vary in a number of ways, including patient inclusion/exclusion criteria, data definitions, and injury severity scoring (HRSA, 2005). And reporting is not mandatory in some states, so state trauma managers estimate that only 70 percent of trauma cases are reported to the registry (Guice and Cassidy, 2004). There have been a number of efforts at the national level to develop trauma registries. In 1985, the National Pediatric Trauma Registry (NPTR) was established to study the causes, circumstances, and consequences of injuries to children. Funded by the National Institute for Disability and Rehabilitation Research, the NPTR contained data on more than 10,000 patients pooled from a number of different states. Data from the NPTR allowed researchers to investigate a number of topics, including the epidemiol-
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Emergency Care for Children: Growing Pains ogy of trauma deaths in rural children (Vane and Shackford, 1995), survival rates at pediatric trauma centers (Osler et al., 2001), and characteristics of bicycle-related head injuries (Li et al., 1995). However, the registry had several problems that limited the usefulness of the data and created challenges for institutions participating in the data collection process (Smith et al., 2001). For example, the registry was a voluntary system without a clear epidemiologically representative catchment area. The NPTR stopped collecting data as of February 2002 (Barnett and Saltzman, 2004). Also in the 1980s, the American College of Surgeons (ACS) collected trauma data for its Major Trauma Outcome Study (MTOS), which was operational between 1982 and 1989. Under the MTOS, researchers from 140 hospitals used a standard collection form for data submission. During its 8-year lifetime, the MTOS collected data on 80,000 cases (Fantus and Fildes, 2003). More important, the MTOS led to the creation of the National Trauma Data Bank (NTDB). When the MTOS ended, the ACS committed to developing a national trauma registry, and the NTDB became operational in 1993 (Pollock, 1995). Today, the NTDB represents the largest aggregation of trauma registry data ever assembled, with 1.2 million records from nearly 500 trauma centers. The ACS receives support for the NTDB from HRSA, CDC, and NHTSA (ACS, 2004). The NTDB is an impressive achievement. Numerous research efforts have been undertaken using the data bank. Additionally, the ACS releases an annual pediatric report that includes more than 235,000 pediatric records from 474 trauma centers in 43 states, territories, and the District of Columbia. The ACS also has a Pediatric Surgery Specialty Group that works with the NTDB Committee to expand the data bank for children, with the goal of receiving data on every pediatric patient treated in every trauma center in the United States (Fildes, 2005). At the same time, the NTDB has some important drawbacks. First, it does not allow population estimates. It obtains data from approximately 61 percent of level I and 51 percent of level II trauma centers (essentially all of which submit adult and pediatric data) (Fildes, 2005), but it collects data only from those hospitals that choose to submit them (NHTSA, 2001). However, the NTDB’s impressive yearly growth (500,000 new cases in 2002) offsets some of the concerns about its representativeness (NHTSA, 2001). The other problem with the NTDB is that it was not specifically designed to capture certain pediatric data elements. The planned advances for the NTDB are promising, however. The ACS was awarded a contract from CDC’s National Center for Injury Prevention and Control to develop a nationally representative sample of U.S. trauma centers that would provide data on trauma patients for the NTDB. Those data will allow researchers to compute national estimates with high confidence. An important part of this project is the inclusion of non–level I and II
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Emergency Care for Children: Growing Pains hospitals. The project has not yet developed a stratum for pediatric patients, but this is intended for the future. Additionally, the NTDB will implement a new set of data elements that will be more conducive to the collection of pediatric data; the original data elements were not defined to capture pediatric information. For example, the new data dictionary contains a field on safety devices so the NTDB can collect specific information on child restraints (Personal communication, M. Neal, March 1, 2006). Recently, another initiative to create a national pediatric trauma registry began. In 2002, the EMS-C program awarded two grants aimed at designing and planning for a National Trauma Registry for Children (NTRC). The goal of the NTRC is “to develop a standardized, nation-wide model to provide accurate estimates of the scope and characteristics of pediatric trauma and to provide a national benchmark for valid comparisons” (Cassidy and Guice, 2005). The resulting data will allow clinical and epidemiological questions to be explored using a more expansive and richer source of information than could be obtained with regional and statewide systems. Under the two grants, researchers identified existing data sources and methods of electronic transfer, defined necessary pediatric data elements and inclusion/exclusion criteria, developed secure data transfer methods, designed a nationally representative sample, and identified methods to ensure hospital participation (Cassidy and Guice, 2005). A third grant was awarded in 2005 to evaluate the quality of pediatric data from state registries that might contribute to the NTRC. However, implementation of the NTRC has not yet begun. The NTRC planning group is expected to recommend two implementation phases. The first will be a population-based injury surveillance system, which will allow researchers to draw population inferences from a statistical sample of national hospitals. The second will be a case contribution component, similar to the original NPTR (Cooper, 2005). It is important to note the collaboration that has occurred between staff from the NTDB and the NTRC. In fact, a representative from the NTDB was on the NTRC planning committee, and a representative from the NTRC assisted NTDB planners with the development of new data elements more suitable for the collection of pediatric data (Personal communication, M. Neal, March 1, 2006). Despite all of the efforts made to enhance the development of trauma systems with interpretive pediatric data, no single trauma registry currently provides accurate estimates of the scope and characteristics of pediatric trauma (Cassidy and Guice, 2005). However, the committee recognizes that the NTDB constitutes the largest repository of pediatric trauma data anywhere (Cooper, 2005) and is taking steps to improve its pediatric capacity. The committee supports the continued progress in this area. The committee recommends that the administrators of state and national trauma registries
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Emergency Care for Children: Growing Pains include standard pediatric-specific data elements and provide the data to the National Trauma Data Bank. Additionally, the American College of Surgeons should establish a multidisciplinary pediatric specialty committee to continuously evaluate pediatric-specific data elements for the National Trauma Data Bank and identify areas for pediatric research (7.2). The planning committee should include pediatric surgeons, pediatric emergency care researchers, and public health and health services researchers. SUMMARY OF RECOMMENDATIONS 7.1 The Secretary of Health and Human Services should conduct a study to examine the gaps and opportunities in emergency care research, including pediatric emergency care, 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, development of multicenter research networks, 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. 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. 7.2 Administrators of state and national trauma registries should include standard pediatric-specific data elements and provide the data to the National Trauma Data Bank. Additionally, the American College of Surgeons should establish a multidisciplinary pediatric specialty committee to continuously evaluate pediatric-specific data elements for the National Trauma Data Bank and identify areas for pediatric research. REFERENCES AAP (American Academy of Pediatrics). 2002. Selecting and using the most appropriate car safety seats for growing children: Guidelines for counseling parents. Pediatrics 109(3):550–553. AAP. 2003. Section on Emergency Medicine, Description of Section Sponsored Awards. [Online]. Available: http://www.aap.org/sections/PEM/awards.htm [accessed November 3, 2004]. AAP. 2005. Section on Emergency Medicine––Collaborative Research Committee (PEM CRC). [Online]. Available: www.aap.org/sections/PEM/pemcrc.pemcrc.htm [accessed September, 28, 2005].
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Representative terms from entire chapter: