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EM Research, Biros 1101

Emergency Medicine Research: Where Are We Now and Where Do We Need to Be?

Michelle H. Biros, M S , M D

I In this issue of Academic Emer- gencv Medicine, Dr. Adam Singer and his co-investigators report a study of the types of research designs pub- lished in 4 emergency medicine (EM) journals compared with those pub- lished in 3 “premier” non-EM jour- nals.’ Their objective was to deter- mine whether the published research in our specialty journals used the same study designs and analyses as did the studies published in the other journals. The investigators deter- mined that the EM journals pub- lished fewer longitudinal, prospec- tive, blinded, or controlled studies, with fewer patients enrolled and fewer acknowledged funding sources. They concluded that the types of studies being published in the EM lit- erature are different. An implication of this study is that EM research (and not simply the research publications in EM journals), if judged by the rigor of the study design, might be considered of lesser quality than the studies being published in the other journals, and therefore may not com- pare favorably with research from other specialties. The authors deline- ate many obstacles to performing emergency research, and suggest that our specialty can contribute to our re- search maturity by encouraging more sophisticated clinical trials.

Specific study designs do not im- ply quality research. The most appro- priate research study design depends on the research question being asked, the feasibility of the research itself, and the ethical considerations sur- rounding the study execution. The as- sessment of the quality of a research study must consider its attention to detail, the identification of confound- ers and design limitations, the vali- dation of the study techniques, and the accuracy of the conclusions based on the results that have been ob- tained. Our publications may reflect

different clinical questions, different research environments, and different obstacles to the performance of re- search than what is encountered in other specialties. We can promote our research development by ensuring the highest possible quality and ethics in all of our research efforts, regardless of the study design used.

The number of enrolled subjects and the source and amount of finan- cial support for a clinical trial do not determine its clinical impact. One method to measure the impact of a research study is to determine how often i t is subsequently cited in other publications. However, even this ob- jective approach would not accurately represent the clinical impact of re- search. I frequently cite the NIH study of tPA in stroke’ and the NIH study of steroids in spinal cord t r a ~ m a , ~ but I rarely have the oppor- tunity to use the recommendations that arose from these studies. I fre- quently use buffered lidocaine in my clinical management of lacerations, but (until now) I have never cited the clinical trial from which this rec- ommendation arose.4 For me, this small, single-site “unfunded” re- search study (with no power calcula- tions) has much greater practical util- ity than these well-funded, large multicentered clinical trials will ever have. EM research development can be promoted by continuing to provide novice investigators with seed money for small projects, and by helping them develop good research habits and sound research principles. We must also acknowledge and reward young investigators who have com- pleted small studies addressing a spe- cific question of clinical importance.

Dr. Singer and co-investigators did not evaluate the content of the publications; they compared only the sophistications of the study designs used. The randomized, blinded, con-

trolled clinical trial, with power cal- culations to ensure the entry of the appropriate number of study subjects, is often the best study design for answering a clinical question. This design measures the effect of an intervention while controlling for confounding variables. It offers a means of evaluating a study agent in the pertinent clinical setting. How- ever, the randomized, blinded, con- trolled clinical trial is not the first step in the research process. Clinical re- search begins with an observation, perhaps described in a case report, which results in the development of a research question. A hypothesis is generated, often from data obtained by observational study. The hypothe- sis is then tested by an interventional trial. The evolution of the study ques- tion into an interventional clinical trial is the natural progression from descriptive to analytical thinking. Dr. Singer points out the recent trend to- ward increasingly sophisticated study designs in funded and published works. Because the published works in the premier journals often describe interventional studies, we might con- clude that this research reflects a greater state of evolution of the re- search endeavor than the research re- ported i n the EM journals. Dr. Singer and coworkers therefore report results that compare the state of our research development with that of other aca- demic medical disciplines. Using these criteria, we fall short.

We can suggest many reasons why EM research is less developed than research from other special- ties. Our research endeavor is even younger than our young specialty. Often our clinical research is in col- laboration with other specialists, who are identified and approached by study sponsors. Emergency research- ers therefore may lack input into, in- fluence on, and control of the re- search that is being done in our clinical setting with patients who are our clinical responsibilities. Not only does this undermine our research credibility and hamper our research

1102 ACADEMIC EMERGENCY MEDICINE DEC 1997 VOL 4 /NO 12

development, it also puts our patients at risk. Unless the strengths, limita- tions, and ethics of data collection in the ED are understood by investiga- tors familiar with the daily practice of EM, study results can be misinter- preted and subsequent recommenda- tions may be irrelevant in the actual clinical setting. Study sponsors and collaborators outside of EM may not recognize our specialty, our knowl- edge base, our talent, and our turf. We need to do more to educate them.

Emergency researchers have been plagued by a number of other obsta- cles that impede our efforts to per- form quality research. acquire neces- sary research skills, and develop research credibility. We may lack available research mentors within our specialty, and our residency training usually provides limited exposure to research practice and principles. We may lack protected nonclinical time and have heavy non-research-related administrative and educational duties. Our nonresearcher clinical colleagues may forget to recruit patients into our clinical studies. We may lack funding sources sympathetic to and knowl- edgeable of the unique research needs of EM. Until recently, our resuscita- tion research was thwarted by gov- ernment regulations that disallowed waiver of informed consent. Managed care and the changing economics of medicine appear to be devaluing re- search and education, and may be negatively impacting scholarly pro- d~c t iv i ty .~

Many of these obstacles are un- changeable. Despite our every effort, they will never change given the na- ture of the clinical specialty we have chosen to practice. Other obstacles are temporary or perceived; with time, they will resolve themselves. The responsibility for reducing the impact of these obstacles is shared between the investigators and the spe- cialty. The risk to EM research de- velopment is using these obstacles as excuses for never starting or com- pleting a research project, or never considering a research career.

Several creative and successful EM researchers, together with their clinical nonresearcher colleagues and chiefs, have worked around many of these obstacles, and their experiences and attitudes may serve as a model for the rest of us. These researchers understand what i t takes to get into the mainstream of clinical research. They find mentors who have achieved the successes that they aspire to, even if these mentors come from outside of our specialty. They often take time out of their clinical career to learn re- search skills through research training fellowships and special programs in statistics, epidemiology, and public health. They understand that this knowledge cannot be acquired in a lecture series or a short course on re- search principles. They go to research conferences, develop research net- works and contacts from outside of our specialty, and keep up with the research literature related to their topic of interest. These researchers recognize that all research is funded from somewhere, and they acknowl- edge and appreciate the support of their nonresearcher colleagues whose clinical activity covers some of their financial needs. They understand that protected time might not necessarily allow reduced clinical hours, and work with their chiefs to reduce other departmental responsibilities. Most importantly, these researchers narrow their research focus. They develop the expertise needed to become recog- nized for a specific research area, and they develop a track record of contin- uous research productivity. Despite the lack of an NIH section for EM research, several have secured NIH funding, and in fact these researchers may have a greater success rate with NIH grant applications than research- ers from other medical disciplines.’-

While it is essential to promote sophisticated research trials and the highest possible quality of research, our specialty can promote the overall development of our research effort in a number of more basic and imme- diate ways. Our leadership must re-

affirm our specialty’s commitment to research as an essential component of our overall clinical mission. We must stress the importance of research training and fellowships, and finan- cially support them. Our residents and clinician colleagues must be taught to value the research enterprise, by the example set by our chiefs and by ac- tive interchange with departmental re- searchers. We should make our resi- dents’ required “scholarly activity” more meaningful. Our researchers must understand what is realistic for their individual research environment and must learn to focus their research activity to defined areas of interest. We must identify obstacles to re- search that can be overcome, and not be defeated by them. We should learn from the research successes of other specialties that have overcome their unique obstacles, and are more ad- vanced in the natural history of the research endeavor. Finally, we must identify and nurture promising young researchers, and nourish our estab- lished investigators.

The research race is fast. We can make convincing arguments that our clinical questions are different, our small studies are more practical, and our obstacles to research are larger than those confronting other specialties. However, outside of our own emergency community, these is- sues aren’t understood and ultimately don’t matter. The unique clinical and academic environment of EM will not factor into the judgment of the wor- thiness of our research when it is evaluated by anyone other than our- selves. We will be judged by the same rigorous standards as are more estab- lished research specialties, and must produce work of the same high qual- ity. Dr. Singer’s work illustrates where we are and where we may need to be if we are to successfully com- pete with other specialties for re- search recognition, funding, and aca- demic credibility.

Dr. Biros is at Hennepin County Medical Cen- ter, Minneapolis, MN. Department of Emer- gency Medicine.

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EM Research, Biros 1103

Address for correspondence and reprints: Michelle H. Biros, MS, MD, Department of Emergency Medicine, Hennepin County Med- ical Center. 701 Park Avenue, Minneapo- lis. MN 55415. Fax: 612-904-4241; e-mail: michelle.biros@co.hennepin.mn. us

Key words: emergency medicine; research; lit- erature; citations; study design.

REFERENCES I. Singer AJ, Homan CS, Stark MJ, Werblud MC, Thode HC Jr. Hollander JE. Comparison of types of research articles published in emer- gency medicine and non-emergency medicine journals. Acad Emerg Med. 1997; 4:1153-

8. 2. National Institute of Neurological Disor- ders and Stroke tPA Study Group. Tissue plas- minogen activator for acute ischemic stroke. N Engl J Med. 1995: 333:1581-7. 3. Bracken MB. Shepard MJ, Collins WF, et al. A randomized controlled trial of methyl- prednisolone or naloxone in the treatment of acute spinal cord injury. N Engl J Med. 1990; 322:1405- 11. 4. Bartfield JM, Ford DT, Homer PJ. Buffered versus plain lidocaine for digital nerve blocks. Ann Emerg Med. 1993; 22216-9. 5. Campbell EG, Weissman JS. Blumenthal D. Relationship between market competition and the activities and attitudes of medical

Ambulance Transports: What Are the Alternatives? Keith W. Neely, MPA

I In this issue of Academic Emer- gency Medicine, Dr. Camasso-Rich- ardson and colleagues examine over- use of emergency medical services (EMS) resources within an urban pe- diatric population.’ Important find- ings include a high rate of ambulance transports judged medically unneces- sary (61%); a high rate of parents’ or guardians’ having no alternative transportation (40%); and, interest- ingly. no association between pa- tients’ having spoken with their per- sonal physician and medical need for ambulance transportation. Addition- ally, among those determined not to require ambulance transportation, there was a willingness among 71% to use alternate transportation, had i t been available.’

Such overuse has been recognized through anecdotal experience for many years. Now, just as utilization management and review has situated itself elsewhere in medicine, EMS use is also under scrutiny. This scru- tiny has revealed the obvious: there is great overuse and thus great oppor- tunity to reduce costs and save money.

As noted in the paper, Alameda County and other communities are considering EMS system redesign to obtain a more appropriate assignment

of resources based on patient need as assessed during the EMS encounter. Additionally, large private ambulance firms are developing their own “pathway management” programs. This product, still under development, will be offered to insurance plans on either a capitated or a discounted fee- for-service basis. In this general model the insurance plan’s utilization protocols and member eligibility data are integrated into the private ambu- lance firm’s communication center data system. Additional linkages are made to a telephone nurse triage cen- ter, nonemergent communication cen- ters, a 9- 1 - 1 dispatch center, and other services, creating a multiple option decision point (MODP) model’ wherein an array of care, transporta- tion, and destination options are available. When an HMO care pro- vider determines a member requires medical transportation, that member is referred to the contracting firm. The ambulance dispatcher, referring to health plan protocols, then provides that caller with a response matched to need.

One private firm has begun beta testing this model in the nonemergent setting with a large HMO. The am- bulance firm’s financial gain comes from providing appropriate, lower-

school faculty. JAMA. 1997; 278:222-6. 6. Moy E, Mazzaschi AJ. Levin RJ. Blake DA. Griner PF. Relationship between NIH re- search awards to US medical schools and the managed care market. JAMA. 1997; 278: 217-21. 7. Varmus H. Keynote address-Society for Academic Emergency Medicine, May 19, 1997, Washington, DC. 8. Angelos M, and the SAEM Research Com- mittee. SAEM research survey results; report to the SAEM board of directors, Nov 1996. 9. Krause G, and the ACEP Research Section. Federal funding of emergency medicine research-report to the ACEP board, Oct 1996.

cost responses under a capitated rate. It is expected that this and similar re- source matching models will be ap- plied in the emergent setting as well.

This paper reinforces an important point: we appear to be unnecessarily overusing EMS resources by 250%. The implicitly asked and equally im- portant question is “Which half is medically unnecessary?” Once that question is answered, the next one presents itself. “How should an EMS community with such information re- configure itself?” Herein lies the work that must be done before such system redesigns can be operational- ized.

T h e balance of this commentary discusses 3 important issues that communities wishing to stratify their EMS response must work through, and proposes a general model to guide policy formulation. The issues are: 1) developing a common, com- munity-agreed-upon definition of emergency; 2) creating validated de- cision-making guidelines to drive alternate resource allocation; and 3) deciding whether these stratified models are a product to be sold to health plans or represent a system re- design for all who call 9- 1 - 1.

DEFINITION OF EMERGENCY Attempting to match EMS resources to patient need is a response to the perceived overuse of EMS resources.