Practical Clinical Research Design and Application

Every practicing physician, surgeon, advanced practice provider, and allied health professional interacts regularly with peer-reviewed literature: either while creating it, or consuming it. Despite the countless hours over many years spent in formal clinical training, many clinicians and clinician-authors lack advanced training or a working nuanced knowledge of research methodology and study design. Institutions have responded to this gap by reinforcing their ranks with statistical and methodological support in the form of data analysts, epidemiologists, and biostatisticians. However, clinicians are often unable to talk the methodological talk to guide them. This ultimately results in a stark disconnect between clinically relevant aspects of research and appropriate study design. Existing research methodology texts are largely written by statisticians, epidemiologists, and other academic public health experts. These are not easily digestible by practicing clinicians who need practical knowledge of this content to design their own research or enhance their understanding of the medical literature. Furthermore, these texts are often too detailed or in the weeds with regard to mathematics and statistical mechanics. Practical knowledge is not centrally located; rather, it is spread out among multiple books, articles, and other sources. This book is a concise, accessible, and practical guide for clinicians to read and reference when designing and reviewing clinical research. It is designed to be a standalone text, written by a clinician, for clinicians by a practicing clinical research expert who has had advanced formal training in research methodology, biostatistics, and epidemiology. Topics covered include descriptive and comparative statistics, power and sample size calculations, diagnostic tests, bias, and study design. In each chapter, consideration is given to study mechanics, advantages and disadvantages of each design, and illustrative analytical reviews of existing literature.