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Guide to Statistics and Methods
Randomized Clinical Trials in Surgery
October 26, 2022

Practical Guide to Design Choice of Randomized Clinical Trials in Surgery

Author Affiliations
  • 1Epidemiology and Data Science, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
  • 2Methodology, Amsterdam Public Health, Amsterdam, the Netherlands
  • 3Department of Emergency Medicine, Denver Health Medical Center, University of Colorado School of Medicine, Denver
  • 4Department of Epidemiology, Colorado School of Public Health, Aurora
  • 5Statistical Editor, JAMA Surgery
  • 6Department of Surgery, Veterans Affairs Boston Health Care System, Boston, Massachusetts
  • 7Department of Surgery, Boston Medical Center, Boston University, Boston, Massachusetts
  • 8Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Surg. 2022;157(12):1154-1155. doi:10.1001/jamasurg.2022.4889

Key elements in guiding the design choice of randomized clinical trials (RCTs) are the research question, the related hypothesis and appropriate methodology, ethics, feasibility, quality of evidence, and efficiency. The strength of RCTs is their internal validity, allowing for causal inference by attributing the observed outcomes to the type of treatment(s) and allowing the randomization to otherwise balance the study groups, thus addressing known and unknown potential confounders.1 RCTs offer high-quality evidence but are not always ethical, feasible, or necessary. If an RCT is feasible and possible,2 a choice has to be made between several options. The involvement of methodological and statistical experts will ensure success in the selection and implementation of the best design. In this article, we present the strengths and weaknesses of several RCT design options (Box).

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