Prehospital care experienced a “honeymoon” from the early 1970s until recently. Treatments usually were extrapolated directly from the hospital setting, even though the prehospital environment is markedly different. That honeymoon is over and emergency medical services (EMS) providers must prove what is beneficial. Additionally, academic prehospital care physicians interested in professional advancement, must show the same ability as do the more traditional medical academicians to expand the knowledge base of their chosen field.

This manuscript will highlight the basic features and identify the potential benefits and pitfalls of prehospital research. This chapter is not a cookbook for EMS research, nor will it obviate the need for accessing other sources on research design. Other manuscripts within this series will focus on more specific topics; yet, it will be obvious that many of the points made here will be re-emphasized in the following papers. That simply is a reflection of the importance of these commonly overlooked perils and pitfalls.

The atrocities committed by Nazi physicians and scientists, in the name of furthering medical science, is an appalling page of the history of medical research. In the wake of World War II, the scientific community strived to develop regulations to guard against future abuses in medical research. However, a particularly sobering thought is that the atrocities in Germany were being carried out in a country that had specific regulations for protecting human research subjects: Nazi Germany was the only European country to have such regulations. A more in-depth look at these regulations reveals institutional or department heads were held accountable, but not the individual researcher. The lesson from this analysis is clear: individual investigators must bear the responsibility of conducting ethical research. Governmental regulations and Institutional Review Boards never can replace investigators who are advocates for the protection of human subjects.

The purpose of this paper is to address issues broadly regarding ethics and prehospital research, with a focus on the topic of informed consent.

Emergency Medical Services (EMS) researchers face a variety of obstacles when conducting out-of-hospital investigations. This paper reviews some common problems and discusses practical solutions to facilitate the process and help avoid traps. This discussion focuses on prospective prehospital research.

One challenge to EMS research is to find new methods of improving the quality of care delivered in the field. There has been an emphasis placed on “exciting” topics, such as cardiac arrest and trauma resuscitation. Other events dominate the daily practice of prehospital medicine, but have not been well-studied. For example, what is the best way to immobilize the spine? What should be done for a patient with a suspected C-spine injury who is wearing a motorcycle helmet? No one has a scientifically proven approach to solve these common prehospital problems. There is a need to look at problems such as immobilization, asthma, overdose, and congestive heart failure to see what can be done differently in the field.

The urban prehospital setting is one of the best venues in which to examine life-saving resuscitation interventions. When the entire catchment of the urban emergency medical services (EMS) system is used, large-population patient studies can be generated. Certain unique features give several urban centers the ability to conduct clinical trials in the out-of-hospital setting. Without resuscitation at the scene, it is rare for cardiac arrest patients to survive. In the case of trauma resuscitation, prehospital care can impact outcome significantly. Since coronary artery disease and trauma kill nearly one-million persons annually in the United States, prehospital care research is a worthwhile endeavor. This rationale for prehospital care research is strengthened by the relatively high potential for full recovery.

For the past two decades, prehospital trauma care has been addressed almost generically in terms of the related approaches to epidemiology, research, and management. However, evolving directions in research have helped emergency medical services (EMS) practitioners to delineate more focused treatment strategies according to the mechanism of injury, anatomic involvement, and the patient's clinical condition. Recent studies in the areas of trauma-associated circulatory arrest, severe blunt head injury, and post-traumatic hemorrhage following penetrating truncal injury suggest that current standard approaches to patient care should be reconsidered. In turn, this need for re-examination of trauma management strategies calls for the development of appropriate evaluation tools within EMS systems. Proper research design is dependent upon several key issues including: 1) the type of study (system study versus examination of a specific intervention); 2), the population under study; 3) physiological and anatomical scoring method; 4) prospective definitions of interventions and meaningful outcome variables (both morbidity and mortality; 5) relative outcome compared to known standards; and 6) prospective determination of statistical requirements.

For more than two decades, emergency medical services (EMS) systems have proliferated primarily based upon governmental impetus and funding at the federal, state, and local levels. Although many of the foundations of patient care rendered in these systems have been based upon intuitive logic, the understanding of the impact on patient outcome is poor, at best. The reasons for the current status are varied, but five issues are preeminent:

1) The authority for the development of these medical systems has been based primarily in political and bureaucratic institutions which have little or no medical expertise;

2) Little attention has been paid to system evaluation, particularly in the area of cost-effectiveness;

3) Few academic medical institutions have become involved in EMS research;

4) Traditional approaches to medical research primarily are disease-specific and are not multidisciplinary. Thus these are not useful for evaluating and understanding the highly complex and uncontrolled environmental interactions that typify EMS systems; and

5) The process of efficiently and reliably collecting accurate data in the prehospital setting is extremely difficult.

Determining the variables that influence survival in the treatment of cardiac arrest is important as both a research and a quality assurance tool. Out-of-hospital cardiac arrest remains the only medical condition in which it has been determined rigorously that prehospital care affects survival. Thus, it uniquely is suited to outcome-based research and quality assurance studies. After approximately 20 years of study, the determinants of survival after cardiac arrest are well-known; however, a plethora of fascinating research questions remain to be addressed.

The prevalence of out-of-hospital cardiac arrest seems to be decreasing. In the Seattle area, there are 30% fewer cases than there were ten years ago. This parallels the overall decline in mortality from ischemic heart disease in the United States in the last thirty years. There also has been a change in the profile of cardiac arrest victims, with today's arrestee several years older than the victim of fifteen years ago. Thus, when one performs comparative clinical trials, the control group of today is very different from the historical control of ten or fifteen years ago.

The following recommendations and suggestions are gleaned from my experience as EMS section editor for an emergency medicine journal. I do not pretend that they are definitive or objective. Nevertheless, to the extent it is helpful to know what passes through the consciousness of one editor, I offer these to individuals wishing to make the transition from aspiring author to published author. May you be successful in adding your contribution to the knowledge of our specialty and profession.

The principal reason to conduct medical research is twofold: 1) to provide an answer to some question that is important to the investigator(s); and 2) to affect the behavior of others involved in the practice of medicine. In order to accomplish the latter of these two objectives, the results of your labors must be published in a reputable medical Journal so that it can impact upon the practice of your peers. To accomplish this, it is necessary to conform to certain rules in the development of the manuscript, and then have the paper evaluated for its relative merits for publication by a panel of your peers. These issues are addressed in this paper.

We all tend to be somewhat naive about the need to write in terms that can be understood and appreciated by our peers. Without clarity and understanding, our work has little impact on others. All that will be accomplished is the knowledge that you think you have gained from what you have done. There are several benefits associated with submission of your hard-earned work for review by your peers. Perhaps the most significant is that the process of peer review constitutes a learning process for the reviewers as well as the authors.