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Guide to Statistics and Methods
Surgical Education Research
January 3, 2024

Practical Guide to Pragmatic Clinical Trials in Surgical Education Research

Author Affiliations
  • 1Surgical Outcomes and Quality Improvement Center (SOQIC), Indiana University School of Medicine, Indianapolis
  • 2Department of Emergency Medicine, University of Colorado, Aurora
  • 3Statistical Editor, JAMA Surgery
  • 4Moseley Professor of Surgery, Department of Surgery, Harvard Medical School, Boston, Massachusetts
JAMA Surg. 2024;159(5):582-583. doi:10.1001/jamasurg.2023.6690

In 1967, Schwartz and Lellouch1 distinguished 鈥渆xplanatory鈥 trials from 鈥減ragmatic鈥 trials by the nature of study intent: clinical trials aim to inform scientific understanding, whereas pragmatic trials aim to inform decision-making. Today, clinical trials are synonymous with efficacy trials (ie, to assess whether the intervention produces an expected result under ideal circumstances); pragmatic trials are synonymous with effectiveness trials (ie, to measure the degree of beneficial effect in real-world settings). This article outlines key features of pragmatic trials within the context of surgical education research using illustrations from the Flexibility in Duty-Hour Requirements for Surgical Trainees (FIRST) trial. The FIRST trial was a cluster-randomized, clinical, pragmatic trial that compared the noninferiority of a flexible resident duty-hour policy vs Accreditation of Graduate Medical Education (ACGME) duty-hour policies (usual care) with respect to patient outcomes and self-reported resident well-being.2,3

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