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National Cluster-Randomized Trial of Duty Hour Flexibility in Surgical Training
Karl Y. Bilimoria, M.D., M.S.; Jeanette W. Chung, Ph.D.; Larry V. Hedges, Ph.D.; Allison R. Dahlke, M.P.H.; Remi Love, B.S.; Mark E. Cohen, Ph.D.; David B. Hoyt, M.D.; Anthony D. Yang, M.D.; John L. Tarpley, M.D.; John D. Mellinger, M.D.; David M. Mahvi, M.D.; Rachel R. Kelz, M.D., M.S.C.E.; Clifford Y. Ko, M.D., M.S., M.S.H.S.; David D. Odell, M.D., M.M.Sc.; Jonah J. Stulberg, M.D., Ph.D., M.P.H.; Frank R. Lewis, M.D.
N Engl J Med 2016; 374:1-15 | February 2, 2016 | DOI: 10.1056/NEJMoa1515724
Concerns persist regarding the effect of current surgical resident duty hour policies on patient outcomes, resident education, and resident wellbeing.
Methods: A national, cluster-randomized, pragmatic, noninferiority trial was conducted at 117 General Surgery residency programs in the U.S. (2014-2015 academic year). Programs were randomized to current ACGME duty hour policies (“Standard Policy”) or more flexible policies waiving rules on maximum shift lengths and time off between shifts (“Flexible Policy”). Outcomes included 30-day postoperative death or serious morbidity (primary outcome), other postoperative complications, and resident perceptions and satisfaction regarding their wellbeing, education, and patient care.
Flexible, less-restrictive duty hour policies were not associated with greater risk of death/serious morbidity (N=138,691 patients; Standard=9.00% vs Flexible=9.06%, p=0.921; OR=0.96, 92%CI 0.87-1.06, P=0.443 (unadjusted); noninferiority criteria satisfied) or any other secondary postoperative outcome studied. Residents under flexible policies did not report significantly greater dissatisfaction with overall education quality (N=4,330 residents; Standard=10.7%, Flexible=11.0%, p=0.86) or wellbeing (Standard=12.1%; Flexible=14.9%; p=0.10). Compared to Standard Policy, residents under Flexible Policy were less likely to perceive negative effects of duty hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education, but more likely to perceive negative effects on personal activities. There were no significant differences between study arms in resident-reported perception of the effect of fatigue on personal or patient safety. Residents under flexible policies were less likely to report leaving during an operation (Standard=13.2%; Flexible=7.0%; p<0.001) or handing off active patient issues (Standard=46.4%; Flexible =32.0%; p<0.001).
Compared with standard duty hour policies, flexible, less-restrictive duty hour policies for surgical residents were associated with noninferior patient outcomes and no significant difference in resident satisfaction with overall wellbeing and education quality. (The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial was funded by the American Board of Surgery, the American College of Surgeons, and the Accreditation Council for Graduate Medical Education; ClinicalTrials.gov number, NCT02050789).
Originally Appeared in The New England Journal of Medicine on February 2, 2016.