Debunking the reigning myths that hinder emergency medicine research
“I am not sure that any research should be performed in emergency department settings, and I suspect that many grant review study sections feel the same way. Patients come to the ED with an acute problem and they need clinical care, not research protocols and consent forms.”
These words of caution came recently from one of my non-emergency medicine research advisors, and they shocked me. I have long realized that within the eyes of federal funding agencies, emergency medicine is still the new kid on the block, without an organ system to call our own or a representative body at the National Institutes of Health (NIH). However, before I received this warning I had believed that EM had carved out a niche in the medical world that included overlapping and complementary roles in clinical care, research, and policy-making to ensure that our patients receive the best care possible – “Anyone, Anything, Anytime.” This essay will explore the roots of my advisor’s viewpoint and suggest counter arguments that I hope will generate additional discussion within the clinical, research, and policy-making communities of emergency medicine.
The Roots of Bias Against Emergency Medicine Research
Three core arguments contest promoting EM as an esteemed medical science alongside our professional colleagues who happen to be represented by institutes at federal agencies:
Vulnerable populations. By definition, EM provides care for individuals whose health concerns are acute, potentially life threatening, and often frightening. Within this time-deprived, emotional and chaotic milieu, how can EM investigators realistically obtain consent from subjects for complicated research? Is randomization possible in this environment? In addition, EM is a single-episode clinical care model without the ability to establish longitudinal rapport with our patients to gauge or communicate the potential risk or benefits of research participation. With this constellation of concerns, can meaningful and minimally biased research hope to succeed in the ED?
No organ system. EM manages a particular spectrum of disease, but does not claim one organ, age group, or gender as their own. The majority of federally-funded research in the U.S. is funneled through the NIH which has been separated into silos that specialize in a particular organ (heart, lung, blood, kidney), pathology (mental health, cancer), or age (pediatric, geriatric). In 2012, there is no “National Institute of Pre-hospital and Emergency Medicine”. In fact, by law, congress would need to close one institute to form a new one and none of the current institutes have volunteered to jump on the chopping block.
The result is that EM research is usually judged by non-EM professionals. Policy-makers have recognized this paradox. In 2006 the Institute of Medicine’s “State of Emergency Medicine” report recommended the formation of an organization to coordinate emergency activities across various segments of government and private sectors. The report noted that emergency-based research and research training could be improved, prompting NIH staff to assess the extent of funding for emergency care and emergency medicine research and research training. In response, the Emergency Care Coordination Center (ECCC) was officially opened in 2008 (see “EP Helms New Federal Emergency Care Agency” on www.epmonthy.com). However, without any NIH institute or independent funding stream, the ECCC impact has not had the effect that a theoretical “Institute of Emergency Medicine” would have.
Few RO1 (independent senior scientist) Funded Researchers. One of the most prestigious grants that federal agencies award is the “RO1”. There are other awards for more junior investigators, but the R-awards distinguish those bench or clinical investigators recognized by their peers as capable of independent investigations. These individuals become the mentors for junior scientists within their research realm and ultimately sit on the study sections that award grants to future scientists. Developing a critical mass to represent EM at federal agencies requires time and sustained commitment.
The Emergency Medicine Response
Vulnerable Populations. It is true that some EM patients – a minority – are critically ill and incapable of initially providing informed consent. Clearly, when contemplating experimental therapies, the risks and potential benefits must be clearly explained to patients and families. This is exactly why Institutional Review Boards (IRB) review research protocols wherever clinical research is conducted. The IRB evaluates the potential risks and benefits to the patient population within the context of clinical equipoise (scientific uncertainty). If no uncertainty exists about a diagnostic test or therapeutic intervention, than exposing any patients to the risk is unwarranted. Yet much, perhaps most, of what we do in medicine is not based upon scientific evidence.
To squelch scientific contemplation and investigation in EM will surely stifle the intellectual growth of our specialty and limit our ability to continue improving patient-centric outcomes. Recent history is filled with examples of emergencies that could only be assessed in the ED (acute myocardial infarction, acute ischemic stroke, post-cardiac arrest therapeutic hypothermia) with randomized controlled trials, yet mechanisms to protect these vulnerable patients were found.
Example: ST-segment elevation myocardial infarction (STEMI). The effectiveness of Intravenous Fibrinolytic Treatment in Acute Myocardial Infarction (GISSI) study proved that streptokinase reduced mortality and that the response was greater when administered sooner after symptom onset. The second International Study of Infarct Survival (ISIS-2) subsequently demonstrated reduced mortality with aspirin, which had a synergistic effect when combined with streptokinase. GUSTO-1 suggested a slight benefit of tissue plasminogen activator (t-PA) over streptokinase. All of these studies were RCT’s recruiting vulnerable (acute MI) patients in hectic ED settings, not from cardiology offices or inpatient beds days after admission. Somehow these investigators found a way to ethically recruit and randomize vulnerable subjects and the result was to improve the management of acute myocardial infarction (decreased mortality and cardiac morbidity).
There is another perspective on vulnerable populations, too. The ED is the safety net for some. They either lack medical/dental insurance altogether or cannot afford the loss of wages that midday office appointments would mandate. Since the ED remains open around the clock and has relatively efficient one-stop shopping for diagnostic testing, prescriptions, and referrals, it is the only pragmatic medical interface for a segment of society. In fact, many of our patients would not obtain timely (or any) medical care if not for their access to the ED. If research neglects to assess new diagnostic tests or therapeutic interventions on this population, clinicians will remain uninformed about how scientific advances apply to this socio-economic segment of patients. While the intent of the “vulnerable population” label is to protect research subjects from predictable risks/harms that they may not be able to understand at the time of consent, completely blocking them access to medical research also ensures that they cannot benefit from medical research and that study findings from dissimilar populations will be applied to them.
No Organ System. The EM “organ system” resides in a unique skill set of diagnosis, resuscitation, and acute stabilization. No other specialty possesses this unique skill set which is why the American Board of Emergency Medicine exists. In my opinion, as current and future investigators advance the frontiers of EM research using accepted methods for RCT’s (CONSORT), diagnostics (STARD), and meta-analyses (PRISMA), the benefits of the unique EM skill set for the individual patient will become increasingly apparent. This mandates the continuation of EM research into the future, which will require increasing funding opportunities as qualified investigators are developed. When the stakes are highest, shouldn’t our patients be able to rely on the highest quality evidence that can only be obtained in our unique setting?
Few R01 Funded Investigators. EM is a relatively young specialty. Within the research universe, EM investigators certainly have much to learn from our bench and clinical scientists in other specialties. The impetus is upon EM to identify and support their most promising investigators, while federal organizations need to ensure that the mentoring infrastructure, funding streams, and study section representation are adequate to ensure that EM patients receive care based upon the priorities and evidence established by and in ED settings. Recently, the National Institute of General Medical Sciences (one institute within the NIH) established the Office of Emergency Care Research “to foster basic, translational, and clinical research and research training for the emergency setting”. This office is meant to provide a conduit between various NIH silos, but has no separate funding mechanism and the acting director is the Deputy Director of the National Institute of Neurological Disorders and Stroke. Not exactly an “Institute of Emergency Medicine,” but it’s a step.
Does EM research have a future? Most definitely. We have much to learn and probably more to teach our colleagues in other fields. As a specialty we will need to continue to identify and promote (academically and metaphorically) our most promising researchers, recognizing the distinct investigative fields of bench, clinical, and implementation science. The ultimate objective is to improve our patients’ outcomes through reliably efficient, cost-effective models of EM care. With presidential debates swirling around a fragile economic recovery and an unprecedented aging demographic while facing an astounding national debt, your voices and perspectives will be essential to ensure a seat at the table for EM research in coming decades. The next evolution in emergency care depends upon it!