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Research, Methods, Statistics

Practical Guide to Statistical Considerations in Clinical Trials in Surgery

To identify the key insights or developments described in this article
1 Credit CME
JAMA Surgery
Published Online: October 26, 2022
Guide to Statistics and Methods
Stijn W. de Jonge, MD, PhD1;
Amy H. Kaji, MD, PhD2,3;
Kamal M. F. Itani, MD4,5
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
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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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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

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Research, Methods, Statistics Surgery JAMA Guide to Statistics and Methods Guide to Statistics and Methods
Article Information

Corresponding Author: Stijn W. de Jonge, MD, Department of Surgery, Amsterdam UMC, location AMC, Amsterdam Gastroenterology Endocrinology and Metabolism, University of Amsterdam, Meibergdreef 9, PO Box 22660, Amsterdam 1100 DD, the Netherlands (s.w.dejonge@amsterdamumc.nl).

Published Online: October 26, 2022. doi:10.1001/jamasurg.2022.4892

Conflict of Interest Disclosures: None reported.

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AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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