Pediatric-related research methodology

Chapter 48
Pediatric-related research methodology


David Markenson


Introduction


For the past several decades, most prehospital research has been conducted with adult participants, largely because it is difficult to access and study the pediatric patient population. In addition, the original models for EMS were focused on trauma (primarily from military experience) and cardiac emergencies, both populations and experiences that did not include children. However, decades of research focusing only on adults have left gaps in the epidemiology of EMS calls for children and on critical treatment information for children. This is disturbing because approximately 5–10% of EMS calls are for children [1].


Pediatric emergency medicine is a relatively young field; as recently as the late 1970s, there were no pediatric emergency medicine textbooks or journals. In addition, although the quantity of research conducted in pediatric emergency care has increased considerably over the past 25 years, there is still little evidence on which to base the prehospital treatments for children as most data are hospital based or extrapolated from adult data. Gaps in knowledge include such basic information as developing the EMS system to include consideration for pediatric patient care, pediatric assessment, and key training aspects for providers. Further, many of the treatments and management strategies practiced by EMS providers today are not supported by scientific evidence. The lack of adequate data and limited research funding are among the most serious barriers to the advancement of research in pediatric emergency care.


Despite an increase in the amount of pediatric emergency care research in the past two decades, and a corresponding increase in pediatric prehospital research due to the efforts of several very committed researchers, centers, and networks such as Pediatric Emergency Care Applied Research Network (PECARN), research to guide optimal prehospital treatment of children for most conditions remains minimal, research directed at outcome measures versus process measures is scarce, and research on the key aspects of effectively teaching providers how to care for children and both establishing and maintaining competency is lacking. The reasons for this deficiency are numerous. One obvious issue is that conducting pediatric prehospital research involves navigating the barriers imposed by conducting prehospital research as well as those obstacles related to conducting pediatric research and those related to educational research. This chapter will build on other chapters on prehospital research by discussing issues unique to conducting pediatric prehospital research.


The need for pediatric prehospital care research


Children represent one-fourth of the US population [2], which translates to more than 73 million infants, toddlers, school-aged children, and adolescents. Furthermore, each age group has very different emergency care needs. For example, the Ontario Prehospital Advanced Life Support (OPALS) study group found that pediatric cardiopulmonary arrest patients were more likely to have unwitnessed cardiac arrests and receive no bystander cardiopulmonary resuscitation (CPR) [3]. The most common arrest etiologies reported were trauma, sudden infant death syndrome, and respiratory disease. Studies such as OPALS provide important information about pediatric patient demographics and the epidemiology of the illnesses and injuries encountered by EMS providers, which is essential to the design and conduct of more in-depth pediatric prehospital care research. Although some of this preliminary research has been done, basic questions still remain. For example, the age distribution of patients treated by EMS, their typical illnesses and injuries, and preexisting medical problems are poorly understood. This type of descriptive research could assist in designing prehospital systems and could also provide baseline data for future analyses by allowing researchers to determine areas of potential study, feasibility of the study within a system, and study planning information such as sample size calculation data.


An additional area for which research is needed is the field of pediatric critical care transport. While neonatal transport might be considered one of the earlier areas of prehospital care, it only represents a small fraction of pediatric critical care transport. Despite being in existence for decades, the actual research on indications for transport, education of providers, and validation of outcomes provided during transport unique to the prehospital environment is scant. The view traditionally has been transport using in-hospital providers with validated in-hospital therapies. The assumption that this will work and its application when in-hospital providers are not used is questionable. With advances in neonatal and pediatric critical care, children who in the past may have not survived are now surviving initial resuscitation and/or are candidates for further care. Therefore research on when it is appropriate to use these scarce pediatric critical care interfacility transport resources, which interventions during transport improve outcomes, and how to effectively educate providers is vitally needed.


Status of pediatric prehospital research


The Institute of Medicine’s (IOM) 2006 report Emergency Care for Children: Growing Pains focused on how pediatric emergency services are (and are not) integrated into the nation’s health care system [4]. Among the issues discussed were emergency care planning, preparedness coordination, funding for pediatric emergency care, training of pediatric emergency care professionals, unique characteristics and needs of pediatric populations, and pediatric emergency care research. The report indicated that, although some progress has been made since the first IOM report on EMS for children was published in 1993 [5], there is still a long way to go to improve the accessibility, quality, and cost of emergency care for children in this country. In addition in its 2009 interim report, the National Commission on Children and Disasters found “death rates due to pediatric injury have dropped by 40 percent since the EMSC program was established. Despite this progress, the gap between adult and pediatric emergency care on not only a day-to-day, but also a disaster basis, is sufficiently large as to require substantial increases in funding for EMSC” and “A significant amount of improvement must still be made to ensure that the emergency care system is prepared for the care of children in both everyday emergencies and disasters.”


From the development of the National EMS Research Agenda in 2001 [6] to the publication of the National EMS Research Strategic Plan in 2005 [7], there has been an exponential increase in prehospital research, yet there is still little research that has been conducted on the prehospital care of children. The 2006 IOM report characterizes the state of pediatric emergency care as a multifaceted crisis, affecting all aspects of emergency care. To drive continued improvements in care, the report asserts that pediatric prehospital care research must become a priority.


While its own discipline, the intersection of disaster medicine and public health preparedness with prehospital medicine, is clear, the need to understand the role and interventions provided in disasters, terrorism events, and public health emergencies is imperative. The research base for pediatric issues in disaster medicine is severely limited based on the same barriers as other areas of pediatric research combined with the challenges of research in disasters.


It is important to note the progress made by the development of some federally funded research networks with the mission of conducting high-quality multicenter collaborative research throughout the United States. One is PECARN, initially funded in 2001; another is the NIH-funded Resuscitation Outcomes Consortium (ROC). Although these networks can potentially conduct pediatric prehospital research, little has emerged to date.


Challenges unique to pediatric prehospital researchers


Many challenges must be overcome when conducting pediatric prehospital research. Many of these are similar to those barriers encountered when conducting general prehospital research and have been covered in other chapters. In addition to these, however, the research population itself presents some challenges which are unique to EMS but which are also common to any pediatric research activity. These include defining a “pediatric” patient, the limited numbers of pediatric patients seen by a typical EMS agency, and the different ethical standards to which pediatric research is held. Specifically, compared to adult studies it can be more difficult to recruit pediatric research participants, to obtain community support for exception from informed consent, and to obtain assent from parents/guardians.


Defining the “pediatric” patient population


In order to conduct any research, one must define both inclusion and exclusion criteria. For the inclusion criteria, basic definitions and biographical/demographic information are key. One can easily understand that a clear definition of the age groups under investigation is critical for anyone conducting quality pediatric prehospital research. One must be clear on how the term “pediatric” or “child” will be defined. Whereas the legal definition of a minor in the United States is a person younger than 18 years of age, the definition of “adult” versus “child” can be highly variable in both the hospital and prehospital settings. The definition can range from as young as 8 to as old as 18 and there may different ages for classifying as adult or pediatric based on presentation, such as one for trauma patients and one for all other patients. There may also be variability even within the same EMS system due to individual hospitals having different criteria for what they consider a pediatric versus adult patient. In addition, within pediatrics some studies would require further subcategorization, such as neonatal, toddler, school age, or adolescent (Box 48.1). Another problem which often occurs is that although most prospective prehospital trauma studies limit inclusion to adult patients, the definition of “adult” can vary from individuals 15 and older up to those aged 18 years and older.

Jun 14, 2016 | Posted by in EMERGENCY MEDICINE | Comments Off on Pediatric-related research methodology

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