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Given rules and regs, is emergency department research even possible?
Chaotic nature of ED, lack of administrative support create problems
As one might expect, emergency physicians prescribe a lot of pain medication. Surveys of emergency department (ED) patients indicate most patients present there in moderate to severe pain. But ED physicians have a difficult time knowing which medications will work best for their patients because research specifically targeted to emergency conditions is lacking.
"We have lots of drugs approved by the Food and Drug Administration for use in the emergency setting, but we’ve never studied them in the emergency department," says Knox Todd, MD, MPH, director of the Pain and Emergency Medicine Initiative in Atlanta, a project dedicated to researching the legal, ethical, and clinical challenges to improving pain management in emergency medicine. "That is one issue we always have with the FDA and approvals."
Industry sponsors don’t have a high comfort level in working with emergency providers because the setting is vastly different from the traditional office-based setting of pediatrics, primary care, gynecology, and other specialties.
The nature of emergency care is that it is unscheduled — hordes of patients may present to an ED with very different medical needs, yet another day the same ED may see few patients. In addition, the patients who do show up will likely never return to the ED for follow-up care.
"A number of people in the pharmaceutical industry are coming to me, saying they know they should be conducting studies in emergency medicine, but they don’t know how to go about it," Todd adds. "There is a large learning curve to doing it."
For example, an investigator may need to observe the participant for longer than a typical ED visit. But where will this observation take place? Space outside the ED will likely have to be allocated because most EDs don’t have extra space available.
"Maybe follow-up visits could be arranged, but it will have to be thought of in a novel way; perhaps the participants can come back to the ED at a time when the department is underutilized and not as busy," Todd says.
Emergency departments are frequently very busy, however. And in addition to the lack of space for observation or follow-up evaluations, many will not be able to allocate support staff to perform the necessary coordination and record-keeping duties necessary for clinical trial administration.
"Trying to do research in a busy clinical environment means you are going to either have people who are dedicated and very motivated to do it, or you will have to bring in additional resources," Todd explains. "Maybe you could train a research nurse to coordinate the study at a couple of sites — possibly a mobile research nurse who could head out to take over the efforts of a clinical trial from other folks at the individual departments who have other things they should be doing."
He currently manages the emergency medicine portion of a large, federally funded, multicenter study examining the effects of air pollution on asthma, stroke, and heart disease. As part of the study, he is collecting data from 20-30 EDs in metropolitan Atlanta. Todd speculates that it might be easier to conduct clinical trials in emergency medicine if sponsors were able to link multiple emergency departments to maximize participation and data collection, while sharing the financial burden of administrative support.
"One of the things I am thinking about for the future is whether there is any interest in setting up a clinical trial network that is a population-based network which could benefit from the local kinds of strength in numbers you get from being able to add resources in a small geographic area," he says.
"I don’t know whether the economies of scale in urban areas like metro Atlanta, with its density of emergency departments, would be useful. But we have certainly found in our epidemiologic studies of air pollution and heart attack and stroke that we need the density of experience. We are able, within this [National Institutes of Health] NIH and [Environmental Protection Agency] EPA-funded study, to capture 1.3 million ED visits a year in a database to model the impact of air pollution." It remains to be seen whether this model will also prove useful for industry sponsors looking to set up a multisite trial, Todd points out.
Studies are possible
Well-controlled, industry-sponsored trials are possible in EDs, but they require a different degree of advance planning, support and, many times, cooperation with other specialties to make them work, says Dexter Morris, MD, PhD, a clinical investigator studying stroke treatment and prevention in the research division of the University of North Carolina (UNC)-Chapel Hill’s department of emergency medicine.
Conducting research in an ED is challenging for a number of reasons, he says. As Todd mentioned, the chaotic nature of most EDs makes organized study difficult. In addition, many departments rely on a high percentage of travel nursing staff, who are not as familiar with the community and who are less motivated to work on research projects.
"You also have rotating attendings, not the same people there every day and, because of the pressure to reduce waiting times and get patients in and out, you don’t have the leisure time to explain and conduct studies," he says.
Emergency medicine also is a newer specialty, and there is not as much of a focus on performing clinical research as there is in other specialties, such as cardiology, neurology and infectious diseases, Todd contends.
Nevertheless, some conditions, like stroke and other sudden-onset, life-threatening illnesses (trauma, acute myocardial infarction, snake and animal bites, etc.) can only be adequately studied in the emergency setting, he adds.
Morris has had success working in conjunction with the department of neurology on several stroke studies.
"For a while, we would alternate principal investigators between the ER and neurology for the trials," he notes. "As many of the stroke [treatment] centers have grown, they are beginning to design their own protocols, mainly involving combinations of intra-arterial and intravenous tPA based upon brain MRI readings. These are probably less standardized, though there are some national trials that are ongoing."
The department at UNC has helped facilitate research by hiring a graduate student in statistics to work part time helping with the design and analysis of clinical trials. And a special summer research program encourages medical students to come in and staff the emergency room and do a variety of pilot studies, he adds.
In the past, Morris has also been able to use the clinical trials department established at the hospital where his ED was located to find IRB and record-keeping support.
"The key thing is getting support to do the trials, either from a clinical trials office or being able to hire your own research coordinator in the department," he advises. "You have to have someone dedicated who will constantly be bird-dogging things and checking to make sure things are going well. Otherwise, the work will not get done and interest will wane."
Once a department or ED group is able to get a body of research going, the research can pay for itself. But getting established is the key. "The department needs to make the commitment that clinical research is important and hire a nurse and/or coordinator with interested physician supervision," Morris says.
"Then it will take off on its own. Sponsors will recognize this and support it, and, at the same time, be wary of sites that don’t have this level of support," he adds.