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.

Peter D. Fabricant, MD, MPH

Attending Orthopedic Surgeon and Education Director, Pediatric Orthopedic Surgery Service

Associate Scientist, Research Division

Hospital for Special Surgery

Associate Professor of Orthopedic Surgery

Weill Cornell Medical College

New York, NY, USA

Dr. Peter Fabricant is an attending orthopedic surgeon on the Pediatric Orthopedic Surgery Service at Hospital for Special Surgery (HSS) and Associate Professor of Orthopedic Surgery at Weill Cornell Medical College in New York, NY. He holds a dual appointment in the Research Division at HSS and serves as the Education Director for the Pediatric Orthopedic Surgery Service. He is a clinician-scientist specializing in pediatric and adolescent sports injuries, trauma, clinical outcomes, and quality improvement research.

Dr. Fabricant completed his undergraduate studies with honors at University of Rochester, and then attended Yale University School of Medicine. During his orthopedic surgery residency training at HSS, he earned a Master of Public Health Degree from Columbia University Mailman School of Public Health.

Dr. Fabricant has an extensive publication and speaking record in pediatric and adolescent orthopedic surgery, sports medicine, and trauma. He has developed a reputation as a clinical and research mentor to medical students and orthopedic surgery residents and fellows, and spends considerable time lecturing and consulting on clinical research and study design locally, regionally, and internationally. 

Dr. Fabricant’s recent investigations have spanned several areas including clinical outcomes, quality improvement, cost-effectiveness, health policy and economics, outcomes metrics and their psychometric properties, basic science, anatomy, and biomechanics. He lives in New York City with his wife, Dr. Son McLaren, their daughter, Avery, and their cat, Bruin.