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intracerebral hemorrhage, there are no proven strategies for emergency management and no proven definitive treatments. Although research design plays a part in the determination of futility of an intervention, we are still left with a paucity of therapeutic interventions to offer patients who experience devastating injury or illness (4). The evidence base for the practice of emergency medicine is modest but continually growing and there are an ever expanding number of highly trained, highly skilled emergency medicine clinical researchers. The challenges for clinical research in the emergency setting are similar to those for research for other acute conditions: interventions are unscheduled and occur at multiple locations of care; diverse teams of care providers are involved; therapeutic interventions are extremely time sensitive, which limits the feasibility of informed consent; and there is a need for medical staff interested and trained in this field of research. CHALLENGES IN EMERGENCY CARE RESEARCH Key factors that contribute to difficulty in conducting research in the ED are time, money, personnel, conflict of interest, disinterest in research, patient mistrust, and regulatory burden. These are, again, not unique to the emergency setting but indeed may be magnified in a dynamic and rapidly changing clinical environment (Table 4-1). Often emergency care researchers come up against practitioner bias for existing therapies. This is a relatively common scenario where there is a poor evidence base for currently used therapies. This creates a situation where equipoise is difficult to achieve and may even make certain things impossible to study if clinical practice has drifted in a particular direction and seems to have acquired the moniker of “standard of care.” Recruitment of subjects into emergency care research studies has particular challenges. There is often a lack of privacy for an informed consent discussion and the individuals approached often lack of familiarity with the environment and the emergency health care provider. The accuracy of data collection in the emergency care setting is an area fraught with concern. Follow-up is uncertain since the goal of emergency clinical care is disposition and there is a mandate to transition the patient to another environment for definitive care; hence there is a lack of long-term ownership of the patient/research subject by the emergency care research investigator. Emergency medicine has been challenged in the development of a qualified workforce of emergency care researchers. There is a shortage of adequately trained laboratory, CHAPTER 4 — KEY ISSUES IN EMERGENCY CARE RESEARCH 21 clinical, and health services investigators. To date, too few emergency physicians have undergone rigorous research training. There are few such role models and very few departments of emergency medicine with substantive training opportunities. Historically, many departmental research directors were junior faculty members who lacked formal fellowship training or NIH funding. There is inadequate protected time for research, poorly defined research-based career tracks, and professional incentives that distract investigators from research-based careers. Even academic medical centers with departments of emergency medicine have traditionally valued clinical care over research (5). Recent patterns of academic development in the specialty indicate that this is changing and will be sustained. There are an inadequate number of interdisciplinary research collaborations and multiinstitutional networks performing emergency care research. There are also significant gaps in data linkages and standardization of clinical care and information systems. And finally, funding sources for emergency care research are both inadequate and frequently aligned across disease-specific boundaries that are not particularly relevant to the practice TABLE 4-1. Key Challenges in Emergency Care Research TIME PERSONNEL ED CONDITIONS Study population Life-threatening, acute conditions, unstable physiology No prior relationship with subject, multiple providers interacting at any given time Crowding, acuity of other patients Intervention Time-sensitive action of drugs or use of devices Shift work, need to train many staff, on-call research personnel who require travel time Storage issues for drugs, devices, and other research materials Data collection Missed time points Difficult to maintain quality oversight Interference due to need for clinical care Infrastructure Dependent on intervention Need to train large number of staff, monitor process Staff burdens, competing clinical tasks, privacy issues Individual patient factors Dependent on intervention Staff uncomfortable with research personnel Staff burdens, competing clinical tasks, privacy issues Informed consent No family or surrogates present may exclude certain populations Off-site personnel, large need for training and orientation; language, literacy, and vulnerability issues Need for clinical care, bias toward staff performing “status quo” Regulatory issues Multiple reviews Inexperience Competing demands for clinical care 22 CHAPTER 4 — KEY ISSUES IN EMERGENCY CARE RESEARCH of emergency care. Emergency patients have nonspecific symptoms and syndromic presentations, making it very difficult to classify important, syndrome-based emergency care research with