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INTRODUCTION

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Clinical research is an essential feature of modern medical practice. Although most areas of medicine present challenges to conducting high-quality controlled studies, the prehospital and emergency care environments are particularly challenging due to numerous uncontrolled variables inherent in developing and implementing meaningful and ethical consent processes. Despite this, an ever-growing body of research in the area of EMS Medicine has helped solidify the subspecialty and moved prehospital care toward a more evidence-based practice. EMS physicians and medical directors must be able to interpret the literature and should aid in its advancement whenever possible.

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OBJECTIVES

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  • Describe basic research concepts and definitions.

  • Describe patient groups and study designs.

  • Describe scientific levels of evidence and grades of recommendation.

  • Standardized reporting of clinical trials.

  • Describe the development of EMS research.

  • National Research EMS Agenda.

  • Describe the design of an EMS study, including development of the research question.

  • Describe the usual IRB process and approach to clinical research.

  • Describe the concept of emergency exception for informed consent.

  • Describe community consultation and public disclosure.

  • Define basic statistical terms.

  • Describe some basic research pitfalls.

  • List existing EMS research databases and discuss how to request access to the data.

  • List sources of potential funding for EMS-related research.

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RESEARCH

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Scientific research is meant to draw investigators and readers of the scientific literature closer to “the truth.” Study design and limitations of conducting research in the clinical environment can drastically affect the results of clinical research, potentially altering the truth being sought. In cases where meticulous design considerations have limited the presence of bias and error, it is possible to utilize study results to advance the practice of medicine. This is the basis for the concept of evidence-based medicine. Acknowledging that not all research study results lead to applicable medical practices, it is important to consider how to best interpret current EMS research results and design future studies.

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BASIC SCIENTIFIC CONCEPTS AND TERMS

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In order for EMS physicians to provide state-of-the-art medical direction and oversight of EMS systems, a basic grasp of the methodology behind clinical research is required. Research concepts and the definitions of common research terms are prerequisites for this understanding.

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EFFICACY

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Efficacy is a description of how well the treatment works in clinical trials (“explanatory”).

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EFFECTIVENESS

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Effectiveness refers to how well the treatment works in the practice of medicine (“pragmatic”).

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VALIDITY

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Validity in research is the degree to which a tool measures what it claims to measure. The validity of a study refers to determining the likelihood that the conclusions drawn from the study are correct or reasonable. A valid study asks the appropriate questions, uses the correct sample (in size and character), collects the correct outcome measures, and utilizes correct statistical methods. This is ...

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