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Course: Practical Guide to Pragmatic Clinical Trials in Surgical Education Research

CME Credits: 1.00

Released: 2024-01-03

In 1967, Schwartz and Lellouch1 distinguished “explanatory” trials from “pragmatic” 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


To identify the key insights or developments described in this article


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