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

Practical Guide to Adjuncts to Clinical Trials in Surgery

Author Affiliations
  • 1Department of Surgery, City of Hope National Medical Center, Duarte, California
  • 2Department of Emergency Medicine, Denver Health and University of Colorado School of Medicine, Denver
  • 3Department of Epidemiology, Colorado School of Public Health, Aurora
  • 4Statistical Editor, JAMA Surgery
  • 5Division of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania
JAMA Surg. 2023;158(1):95-96. doi:10.1001/jamasurg.2022.4904

Choosing outcome parameters is essential for success of any clinical trial. The Institute of Medicine (IOM) has put forth a framework of 6 parameters that define health care quality: safe, effective, patient-centered, timely, efficient, equitable.1 Safety and effectiveness are primary goals and will be discussed in other articles in this series. Here, we discuss adjunct outcome parameters that optimize patient-centered, timely, efficient, and equitable components (Box). We also discuss novel data collection methods, including web- and app-based data collection and data from wearables. Secondary outcome parameters allow interventions with similar primary end points (survival or functional outcome) to be distinguished in value. The parameters discussed also provide mechanistic analysis and finding inclusion criteria for future trials that decrease sample size and increase likelihood of success.

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