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

Practical Guide to Statistical Considerations in Clinical Trials in Surgery

Author Affiliations
  • 1Department of Surgery, Amsterdam UMC, location AMC, Amsterdam Gastroenterology Endocrinology and Metabolism, University of Amsterdam, Amsterdam, the Netherlands
  • 2Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California
  • 3Statistical Editor, JAMA Surgery
  • 4Veterans Affairs Boston Health Care System, Boston University, Boston, Massachusetts
  • 5Harvard Medical School, Boston, Massachusetts
JAMA Surg. 2023;158(1):89-90. doi:10.1001/jamasurg.2022.4892

Statistics is the discipline that helps in making meaningful inferences about the real world from data. Statistics is founded on a construct of hypothesis testing, relying on a range of conditions and assumptions to estimate unbiased treatment effects and differentiate these from chance. Careful consideration of the hypothesis and the corresponding conditions and assumptions are required when formulating the research question and designing and executing a trial up to the interpretation of the results. Like surgery, statistics is a discipline to which one can devote a life of learning and practice that cannot be casually applied. It is therefore important to include a biostatistician from the start and through all phases of the project. We hereby briefly summarize some of the key statistical considerations in clinical trials in surgery (Box).

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