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Editor's Note
March 2016

FIRST Trial—Decision to Publish a Description of the Study

JAMA Surg. 2016;151(3):281. doi:10.1001/jamasurg.2015.5442

The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial is an important study assessing the value of the recent changes in work hours for surgical residents.1 It is unclear if the change in work hours improves or adversely influences outcomes for residents and/or patients. Although various adverse outcomes have been associated with long weekly work hours, it is uncertain whether the increased “handoffs” associated with reduced work hours and a limitation on the length of shifts can adversely affect either residents or patients.

This article1 was accepted prior to the recent concerns raised by Public Citizen and the American Medical Student Association about the ethics of the study.2 The article is not a report of the outcomes of the clinical trial, but rather a description of the study, including various details regarding ethical approval. Bilimoria and colleagues detail the review by the institutional review board office of Northwestern University, and acknowledge that hospitals in one state (New York) were “ineligible to enroll as duty hour requirements are enforced by state law,” and 6 programs chose not to participate. We recognize the controversy about the ethics of the study and believe that transparency about the way in which it was approved and conducted should be reviewed and discussed.

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Article Information

Conflict of Interest Disclosures: None reported.

References
1.
Bilimoria  KY, Chung  JW, Hedges  LV,  et al.  Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial protocol: a national cluster-randomized trial of resident duty hour policies [published online December 30, 2015]. JAMA Surg. doi:10.1001/jamasurg.2015.4990.
2.
Letter to OHRP regarding the FIRST trial comparing standard and long work schedules for general surgery residents. November 19, 2015. http://www.citizen.org/hrg2284. Accessed December 1, 2015
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