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Emergency Care for Children: Growing Pains (2007)

Chapter: 7 Building the Evidence Base for Pediatric Emergency Care

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Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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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-

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

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

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

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-

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

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.

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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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

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

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.

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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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?

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×
  • 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.

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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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

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

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

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

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).

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

burden of illness and injury in children and/or produce savings is currently not well understood. Few research efforts have evaluated the effectiveness of ED-based injury control and prevention interventions for children and their parents (Mace et al., 2001; Johnston et al., 2002). As a result, it is difficult to determine the extent to which emergency providers should be pressed to undertake such activities. And because little support has been provided for injury prevention research, it is unclear which prevention strategies are likely to produce the greatest benefit.

Justification for Increasing Pediatric Emergency Care Research

Much is unknown about the nation’s emergency care system, particularly with regard to pediatric patients. But numerous other unanswered questions within the health care system remain unanswered. What makes pediatric emergency care worthy of the scarce resources available for health care research?

Rivara (1993) proposed a set of criteria for selecting research topics in general pediatrics, but his criteria are easily applied across all health care research efforts. According to Rivara, research should focus on problems that (1) occur frequently, (2) are severe, and (3) could potentially be alleviated by taking action. Pediatric emergency care research meets all three of these criteria. First, utilization data from individual EMS agencies and national data from NHAMCS indicate heavy reliance on the emergency care system among pediatric patients. Children visited EDs nearly 30 million times in 2003. Pediatric patients account for approximately 27 percent of all ED visits and 5 to 10 percent of all EMS transports. The frequency with which the emergency care system encounters pediatric patients contributes to the need for research in this area.

Second, while the majority of calls to EMS and visits to the ED do not involve life-threatening emergencies, the system must be well prepared for sick and injured children. The severity of illnesses and injuries encountered by emergency providers—some of which are life-threatening—provides ample justification for efforts to expand research in the area.

Finally, the potential to overcome deficiencies in the emergency care system through research is real. The EMS-C program, through its network of grant coordinators in each state, has the infrastructure to help incorporate changes in practice that are suggested by new research, as would the new federal lead agency for emergency care proposed in Chapter 3. The potential for change would be even greater in communities that adopted the regionalized system of emergency care services proposed in Chapter 3, under which the coordination and organization of the system would be stronger.

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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ADDRESSING BARRIERS TO PEDIATRIC EMERGENCY CARE RESEARCH

The barriers that presently hinder emergency care research in general also apply to research in pediatric emergency care. Among the most commonly cited barriers are (1) inadequate funding (ACEP Research Committee, 2005); (2) limited availability of data, especially in the prehospital environment; and (3) a shortage of adequately trained investigators with sufficient protected time to develop a clearly defined research focus (Stern et al., 2001; Lewis, 2004). Additional barriers exist to the conduct of prehospital emergency care research. Survey data show that EMTs identify both a lack of interest and a lack of knowledge about the purpose of research as major barriers (Singh et al., 2004).

To address these barriers, the committee recommends that the Secretary of Health and Human Services 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 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 (7.1).

Limited Funding for Pediatric Emergency Care Research

To improve the evidence base for pediatric emergency care interventions, there is a need for larger, multicenter studies that can provide greater statistical power and more complexity in terms of analytic design and questions investigated. These more sophisticated studies require significant amounts of funding support (Havel, 2004). However, funding for research in emergency medicine has traditionally been very limited and is highly competitive.

Some progress has been made by pediatric emergency medicine researchers in securing federal funding, particularly with the introduction of PECARN; nonetheless, funding continues to remain a critical barrier. Of the limited federal funds available for emergency care research, a small amount is directed toward pediatric studies. In 2004, SAEM identified a total of just 106 federal grants from various agencies covering a wide rage of emergency care topics. Of these, only 11 were focused on pediatrics and

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

4 on prehospital care. Of the 11 grants focused on pediatrics, only 1 was a basic science investigation (ACEP Research Committee, 2005).

A key characteristic of much emergency care research is its tendency to cut across multiple specialty domains. Emergency care research is often not based on a single disease entity, and simultaneously incorporates characteristics of both efficacy and health services research. This has made it difficult for emergency medicine researchers to obtain training grants from the siloed funding structure of NIH, the largest single source of support for biomedical research in the world (IOM, 2004). The broad nature of emergency medicine research does not fit well into the highly specific focus of individual NIH institutes. According to a 2005 ACEP report on emergency medicine research, “even institutes with a potential focus on emergency medicine, such as the National Institute of General Medical Sciences (NIGMS) [which includes a trauma research center and trauma training program], view funding emergency medicine training programs with skepticism.” The ACEP Research Committee made a formal inquiry to the NIGMS program director regarding funding specifically for emergency medicine research. The program director described several barriers. For example, the NIGMS budget dedicated to training has remained constant, while trainee costs have risen. These budgetary pressures have led to a reduction in the total number of trainees the institute can support. In the absence of increased funding, it is highly unlikely that NIGMS will initiate a new category of training programs to foster the development of emergency care researchers. The program director also noted that although emergency medicine research covers medical issues that are within the missions of many individual institutes, it is doubtful that any single institute would support a generic program covering multiple research or training areas, as a training program in emergency care research would necessarily do (ACEP Research Committee, 2005). The same problems exist for pediatric emergency care research.

As recommendation 7.1 suggests, specific opportunities and funding streams for pediatric emergency care research should be identified and prioritized. This funding should target emergency medical and trauma care for both children and adults, including prehospital and ED care, disaster medicine, critical care, mental health emergencies, and prevention. Projects should encompass the full range of relevant research—basic, translational, and health services research, as well as clinical outcome studies—with an emphasis on the generation and testing of evidence-based prediction rules, health service delivery practices, behavioral/mental health studies, and education research.

One of the impediments to grant funding for emergency care research in federal agencies has been the lack of emergency care researchers involved in the development of intramural and extramural research strategies and in grant review panels. This situation is due in part to the cross-cutting nature

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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of the discipline, as discussed above. It is also due in part to the recency of the fields of trauma and emergency medicine and the lack of a large cadre of mature investigators, as discussed in the next section. While the development of investigators is an imperative for the field, the number of mature investigators is growing, and they should have a stronger presence in grant review processes in the future. This should occur naturally as a greater effort to support emergency care research is made by NIH and other federal funders.

Enhanced cooperation is also needed among federal agencies in the development of multiagency research announcements and the coordination of funding for pediatric emergency care research projects. There is a precedent for this sort of activity. In response to the 1993 IOM report on emergency care for children, which called for an increase in funding for pediatric emergency care research, a multiagency announcement was released in 2001 that focused on improving the quality and quantity of research in this area. The announcement included AHRQ, the Health Resources and Services Administration’s (HRSA) Maternal and Child Health Bureau, the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health, and four NIH institutes—the National Institute of Child Health and Human Development, the National Institute on Drug Abuse, the National Institute on Mental Health, and the National Institute of Nursing Research. In 2002, eight funded projects cited this announcement as the point of referral for their proposals; in 2003, seven research awards were made for which the announcement was the initial contact for the investigators (data courtesy of Isabelle Melese d’Hospital, EMSC National Resource Center). The program announcement expired in January 2004, but in April 2005, an updated multiagency program announcement was released.

Collaboration should extend beyond federal agencies to include foundations and other sources of support (see Box 7-2). While the total funding available for pediatric emergency care research is limited, the dollars flow from a large number of different sources, including state block grants, private foundations, professional societies, and industry, although these funding streams are not always reliable, and they almost always tend to be fragmented. These funding organizations should coordinate resources that support pediatric emergency care research so that the dollars will be directed to the most appropriate studies, and overlap will be avoided.

Not only do nonfederal organizations represent a potential source of research support, but they may also provide essential venues for the diffusion of new pediatric research findings. For example, the annual meeting of the Pediatric Academic Societies is a venue for sharing information about interdisciplinary aspects of pediatric medicine. Similarly, the annual meetings of SAEM, the Emergency Nurses Association, and the National Association

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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BOX 7-2

Potential Sources of Support for Pediatric Emergency Care Research

Although federal support for pediatric emergency care research is rather limited, a number of government agencies, given their mission, could be potential supporters of such research. Each of the agencies listed below should better define and expand its role in supporting pediatric emergency care research. A short description of each agency is provided. Potential foundation and industry sources are also identified.


Federal Agencies

Several government agencies are involved in clinical and health services research. Although the funding is not typically targeted specifically to pediatric emergency care research, researchers in the field may be able to tailor their research topics to match an agency’s substantive area of interest, such as mental health, cardiac care, or injury. Within the federal government, the following agencies can and should play an important role in pediatric emergency care research.

National Institutes of Health (NIH). NIH is the main federal organization funding health and behavioral research. It consists of 27 separate institutes and centers that conduct and acquire the results of both basic and applied behavioral and biomedical research. NIH supports the research of nonfederal scientists in universities, medical schools, hospitals, and research institutions throughout the United States and abroad.

NIH does not have an institute or center focused specifically on emergency services. However, emergency medicine research may be appropriate for any of the individual institutes or centers, depending on the research topic. For example, the National Heart, Lung, and Blood Institute has encouraged the submission of applications for research that includes studies aimed at developing and evaluating programs in which the emergency department (ED) is used to introduce effective asthma management strategies, as well as epidemiological studies aimed at identifying risk factors for ED visits. Support for studies on pediatric emergency care could potentially be obtained from the National Institute for Child Health and Human Development (NICHD), which has encouraged applications for research examining outcomes of emergency care for acutely ill children and care of suicidal children and adolescents. As of July 2004, two-thirds of NICHD grants were for projects related to pediatric critical care and one-third for those relate to pediatric rehabilitation.

Although the NIH budget has expanded in recent years, this growth has not translated to an increase in funds for emergency medicine research. Emergency medicine has traditionally faced larger hurdles in competing for NIH funding relative to other medical fields (Marx, 2004).

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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Department of Health and Human Services (DHHS). A number of agencies within DHHS are potential supporters of pediatric emergency care research:

  • Agency for Healthcare Research and Quality (AHRQ). The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care. Unlike NIH, which tends to fund work that is more clinical in nature, AHRQ tends to fund health services research. In 2004, AHRQ received an allocation of $304 million to be used for funding a variety of health services and outcomes research, continued collection of key data characterizing the provision of health care in the United States, and a variety of specific activities mandated by Congress. For example, the 2005 AHRQ administration request included $84 million for patient safety research and $50 million for information technology, and may include $50 million for effectiveness evaluation of prescription drugs. Because funding for AHRQ is increasingly tied to specific activities, progressively fewer funds have been available to support investigator-initiated research and research training. Nonetheless, AHRQ remains a major source of funds for health services and outcomes research, with an intense 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 to its credit, AHRQ has funded some important studies in this area, including a pediatric airway management project (Gausche et al., 2000). A number of emergency care specialists have served on standing grant review panels and special emphasis panels for AHRQ.

  • Health Resources and Services Administration (HRSA). HRSA’s mission is to improve health care access. The agency awards grants and contracts primarily to support programs and demonstration initiatives. HRSA’s Maternal and Child Health Bureau (MCHB) has a dedicated funding source for pediatric emergency services under its Emergency Medical Services for Children (EMS-C) program. The EMS-C program provides infrastructure support for the Pediatric Emergency Care Applied Research Network (PECARN), described in more detail in the text. The MCHB Research Program also funds pediatric emergency care research projects including PECARN studies. HRSA’s Office of Rural Health Policy also supports research efforts through its Rural Health Research Center program. This program is dedicated entirely to producing policy-relevant research on health care in rural areas. Eight centers have cooperative agreements with HRSA to conduct this research, and each year, specific research topics for the centers are selected jointly by the research center directors and HRSA staff. Although the majority of studies are not focused on emergency

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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care, one examined access to EMS, and others have looked at how changes in the health care system affect ED use.

  • Indian Health Service (IHS). IHS is the federal government’s primary advocate for delivery of health care services to Native Americans. IHS manages EMS-related activities through contractual arrangements with tribal groups, which direct a total of approximately 75 EMS programs involving some 600 emergency medical technicians (EMTs). The EMS-C program, MCHB, and HRSA contracted with IHS to develop a set of activities designed to obtain information on the capabilities of Native American tribes to serve children in emergency situations. IHS will conduct a national assessment of all Native American tribal EMS programs to obtain the information needed by MCHB to assess the state of readiness of tribes to serve children in emergency situations (EMS-C National Resource Center, 1999).

  • Centers for Disease Control and Prevention (CDC). CDC is the lead federal agency for protecting the health and safety of U.S. residents. Its focus is on disease prevention and control, environmental health, and health promotion and education activities designed to improve the health of the population. CDC works with partners to detect and investigate health problems and conduct research aimed at enhancing prevention (CDC, 2004). Like NIH, CDC is organized into centers, institutes, and offices. The centers, institutes, and offices respond individually in their areas of expertise and pool their resources and expertise on cross-cutting issues and specific health threats. The National Center for Injury Prevention and Control is 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. The program also funds research in the two major disciplines involved in injury control research: biomechanics and epidemiology. 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 Injury Research Agenda was developed with extensive input from academic research centers, national nonprofit organizations, and other federal agencies with a stake in injury prevention. The document will guide research in seven areas of injury prevention and control. The current plan for implementation of the agenda is to seek $250 million in appropriations over 5 years to support research in six broad areas, all of which are directly relevant to emergency care research. Emergency providers are well positioned to interact with CDC on various efforts, including participating in extramural and intramural projects, serving on advisory and grant review committees, and providing input on the agency’s recommendations (Carden et al., 1998).

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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  • Centers for Medicare and Medicaid Services (CMS). CMS is responsible for administering the Medicare program and, in partnership with states, the Medicaid program and the State Children’s Health Insurance Program (SCHIP). CMS supports a number of research projects in an effort to provide better services to program beneficiaries. Many of the research studies currently funded by CMS involve children enrolled in Medicaid and SCHIP, but none are specific to emergency care services.

Department of Transportation (DOT). The National Highway Traffic Safety Administration (NHTSA) within DOT has the mission of reducing deaths and disability, as well as health care costs, resulting from motor vehicle crashes, medical emergencies, or other injury incidents. NHTSA’s Office of EMS works to enhance emergency medical care for those injured in motor vehicle crashes and acknowledges that to ensure optimal care for crash victims, EMS systems must be prepared to provide a comprehensive range of community health services. Therefore, the agency’s EMS support is directed broadly at a range of system needs. The agency is closely aligned with MCHB in support of the EMS-C program. Together with MCHB, the Office of EMS commissioned the National EMS Research Agenda, which describes the history and current status of EMS research. It also describes strategies for improving the quality and quantity of EMS research, with the goal of providing a scientific foundation for current and future prehospital care.


Department of Defense (DoD). The military provides care to more than 3.5 million children. DoD and HRSA work together to explore pediatric access and quality improvement issues in emergency care in the developing managed care delivery system. Additionally, in 1990 Congress mandated that DoD conduct a special study of pediatric EMS systems within its military treatment facilities as part of a national initiative to improve the quality of children’s medical services. The goals of the study continue to be relevant and include assessing EMS, evaluating the effectiveness of EMS within DoD, and identifying specific opportunities for improvement (DHHS et al., 2000).


Department of Homeland Security (DHS). The mission of DHS is to secure the homeland. Within that broad mission, the Federal Emergency Management Agency (FEMA) is the federal coordinating entity responsible for emergency preparedness, response, recovery, and mitigation. FEMA works with other federal, state, and local agencies to coordinate response and recovery operations following a major disaster. It also operates the FEMA for Kids Program, which provides resources for children and families on line. Within FEMA, the U.S. Fire Administration is involved in prevention programs, for example, a public safety campaign to reduce deaths from fire among infants and toddlers. FEMA does not appear to commission many research studies

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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but certainly is a relevant participant in the provision of EMS for children, particularly as related to disasters.


Private Organizations

The financial support available from private organizations is typically more limited than that from federal sources; however, some private organizations have funding targeted specifically at emergency services or emergency medicine research.

The Emergency Medicine Foundation (EMF) was created in 1973 as the education and research arm of the American College of Emergency Physicians (ACEP). Organized as a not-for-profit, EMF is unique in that it awards funding for education and research solely in the area of emergency medicine. Funding for EMF grants comes from donations by individual emergency physicians, physician groups, corporations, and other foundations. ACEP underwrites all of the administrative expenses of EMF. EMF grant funding has grown considerably since the foundation’s inception. During the first grant cycle in 1981–1982, EMF awarded 2 grants totaling $8,500; in 2004–2005, it awarded 18 grants totaling nearly $500,000 (Pollack and Cairns, 1999).

The Society of Academic Emergency Medicine (SAEM) operates its own Research Fund, supported by donations from members. The fund has about $2 million in reserves, and SAEM hopes to expand it to increase the number of grants awarded (SAEM, 2004). The fund supports several different types of grants designed to promote the development of research skills rather than to support any particular research project.

The National Emergency Medicine Association (NEMA) also offers grants to emergency medicine researchers. The organization is committed to trauma prevention and the delivery of quality medical services at each stage of trauma

of EMTs represent opportunities for pediatric emergency care researchers to disseminate new information to emergency care providers.

The Dearth of Well-Trained Pediatric Emergency Care Researchers

Many authors have decried the lack of a sufficient pool of well-trained laboratory and patient-oriented investigators in emergency care and have identified it as a major barrier to emergency care research. Emergency care providers who are also basic science investigators or who collaborate with such investigators may serve as an excellent bridge for translating the findings of basic investigations to the emergently ill patient and for bringing unanswered questions back to the laboratory. But medical training in pediatric emergency medicine, like that in emergency medicine generally,

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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care, with an emphasis on first response at the time of the emergency. NEMA grants provide funding to hospitals, health clinics, trauma centers, fire departments, and physicians. Awards go to small, underfunded rural organizations as well as to well-established entities (NEMA, 2003).

For pediatric emergency medicine research, there are additional associations and foundations that may provide financial support. The American Academy of Pediatrics’ (AAP) Section on Emergency Medicine offers a young investigator award of $10,000 for a research project that addresses issues pertinent to the acutely ill or injured child. It also offers several awards that recognize individuals who have made significant contributions to research in pediatric emergency medicine (AAP, 2003). The Ambulatory Pediatric Association, an organization of academic pediatric health professionals, offers a young investigator grant that provides up to $10,000 per project to new investigators for research in a number of areas, including pediatric emergency medicine (Christakis et al., 2001). Finally, researchers seeking funding for relatively small projects may be able to obtain it from their local tertiary pediatric referral center (Havel, 2004).


Industry

Industry or corporate funding constitutes a small source of support for clinical research in pediatric emergency care. The biomedical industry provides some funding for emergency medicine research, particularly evaluations of new drugs or medical devices. Emergency medicine physicians are in a good position to conduct this work since the ED is the initial site of diagnosis and treatment for many illnesses. This makes it an ideal setting for clinical trials of time-critical pharmaceutical agents, diagnostics, and medical devices (Morris and Manning, 2004).

is heavily focused on the development of clinical skills, with little time for formal training in research methodology (Biros et al., 1998). Clinical fellowships are more numerous and more likely to be funded than research fellowships. In 2003, only 12 percent of fellowships in the SAEM listing appeared to have a primary research focus, and only about 70 percent of those positions were filled. None were backed by federal funding from NIH or other agencies. In addition, only 11 percent of the advertised fellowships offered an advanced degree, such as a PhD, MS, or MPH, during the course of fellowship training, although others may offer that option (Pollack et al., 2003).

While some clinical fellowships have a research component, a research training program that does not include 2 years of dedicated research training (e.g., greater than 80 percent research time) is unlikely to result in long-term

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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success in today’s research climate (NIH, 2003). Formal fellowship training is now a well-recognized requirement for those embarking on a successful long-term research-based academic career (Stern et al., 2001).

As detailed in a report by the ACEP Research Committee, a substantial portion (27 percent) of all emergency medicine trainees intend to pursue an academic career, while paradoxically, the research and research training support devoted to emergency medicine and emergency care is very low. Of the 1,281 NIH training grants to medical school departments awarded in 2003, only 1 went to a department of emergency medicine. This lack of funding is even more striking when compared with that in other medical fields. For example, fewer than 9 percent of internal medicine trainees expressed a desire to purse an academic career, but NIH awarded 354 training grants to departments of internal medicine in 2003 (ACEP Research Committee, 2005). However, when emergency medicine trainees express a desire to pursue academics, it is likely that most envision themselves as clinical educators rather than federally funded investigators. While existing foundation support has increased the number of well-trained emergency care investigators, a significant increase in the total research training support available will be required to substantially expand the nation’s emergency care research capability.

As discussed in Chapter 4, most pediatric emergency medicine physicians hold their primary board certification in pediatrics; moreover, most pediatric emergency medicine fellowships in the United States are organized under the pediatric residency review committee (RRC) governed by the rules of the American Board of Pediatrics (ABP). The ABP requires that pediatric emergency medicine fellowships include a meaningful scholarly project; however, the vast majority of pediatric emergency medicine trainees pursue clinician educator career paths that emphasize clinical service in pediatric emergency medicine and bedside teaching rather than academic research. Like pediatric emergency medicine fellowship programs organized under the emergency medicine RRC, pediatric emergency medicine fellowships under the pediatric RRC infrequently result in research-intensive academic careers. Historically, these fellowships have not provided research experiences that have led to sustained, independent research contributions following the fellowship.

While there is scarce funding for emergency and trauma care researchers, research training for EMS personnel is more limited still. Unlike the medical field, in which research fellowships exist, there is no clear path to the development of research expertise in EMS. As a result, EMS research is fostered largely by researchers trained in emergency medicine (Sayre et al., 2002).

One potential strategy for addressing this barrier is to promote and fund centers of excellence in emergency and trauma care. Such centers of excellence would provide funding that would allow experienced researchers to

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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work with young investigators on projects, supporting mentorship. A series of 2-year “fellowship” opportunities could target promising young researchers to enable them to gain skills in research methodology. This goal could be met by establishing centers of excellence funded by NIH; expanding the availability and appropriateness of K-awards; and enhancing cooperation among federal, professional society, and foundation partners for the funding of young investigator awards.

Another strategy would be to develop training grants for emergency medicine educators, as well as to offer support for training programs to prepare midlevel providers, such as EMTs, nurse practitioners, and physician assistants, for conducting and participating in research. Presently, midlevel research development grants are restricted to primary care specialties, thereby excluding emergency physicians and other providers of emergency care. There is a pressing need for access to training grants, including K23 and K08 applications, specifically targeting emergency and trauma care researchers. T32 training grants should be offered to the relatively few academic departments or divisions of emergency medicine that have established viable lines of federally funded laboratory clinical and/or health services research. In addition, health care foundations concerned with reducing health care disparities and promoting access to care (such as The Robert Wood Johnson Foundation and The Henry J. Kaiser Family Foundation) should fund career development awards and fellowship programs for emergency care and trauma physicians.

Data Limitations

One of the challenges of conducting research on emergency care services is that no single institution is likely to have access to sample sizes large enough to answer important questions about critically ill individuals, particularly children. For example, a 10-center study of children with diabetic ketoacidosis identified only 61 cases of cerebral edema during the 15-year study period (Glaser et al., 2001). Similarly, a study intended to produce a decision rule for computed tomography (CT) scanning of the brain found that fewer than 1 percent of children with minor head injuries required a neurosurgical intervention (Atabaki et al., 1999). Decision rules based on small samples tend to suffer from unacceptably wide confidence intervals, so the validity of the findings are limited (PECARN, 2003). Discussed below are several options for overcoming these data limitations.

Research Networks

The use of research networks to overcome the challenge of data limitations has proven successful in the past. The large number of patients

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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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-

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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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-

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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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-

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

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

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
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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

Suggested Citation:"7 Building the Evidence Base for Pediatric Emergency Care." Institute of Medicine. 2007. Emergency Care for Children: Growing Pains. Washington, DC: The National Academies Press. doi: 10.17226/11655.
×

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.

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Children represent a special challenge for emergency care providers, because they have unique medical needs in comparison to adults. For decades, policy makers and providers have recognized the special needs of children, but the system has been slow to develop an adequate response to their needs. This is in part due to inadequacies within the broader emergency care system. Emergency Care for Children examines the challenges associated with the provision of emergency services to children and families and evaluates progress since the publication of the Institute of Medicine report Emergency Medical Services for Children (1993), the first comprehensive look at pediatric emergency care in the United States. This new book offers an analysis of:

• The role of pediatric emergency services as an integrated component of the overall health system.

• System-wide pediatric emergency care planning, preparedness, coordination, and funding.

• Pediatric training in professional education.

• Research in pediatric emergency care.

Emergency Care for Children is one of three books in the Future of Emergency Care series. This book will be of particular interest to emergency health care providers, professional organizations, and policy makers looking to address the pediatric deficiencies within their emergency care systems.

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