title: National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training.
abstract: BACKGROUND
  Concerns persist regarding the effect of current surgical resident duty-hour policies on patient outcomes, resident education, and resident well-being.
  
  
  METHODS
  We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving 117 general surgery residency programs in the United States (2014-2015 academic year). Programs were randomly assigned to current Accreditation Council for Graduate Medical Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies that waived rules on maximum shift lengths and time off between shifts (flexible-policy group). Outcomes included the 30-day rate of postoperative death or serious complications (primary outcome), other postoperative complications, and resident perceptions and satisfaction regarding their well-being, education, and patient care.
  
  
  RESULTS
  In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies were not associated with an increased rate of death or serious complications (9.1% in the flexible-policy group and 9.0% in the standard-policy group, P=0.92; unadjusted odds ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P=0.44; noninferiority criteria satisfied) or of any secondary postoperative outcomes studied. Among 4330 residents, those in programs assigned to flexible policies did not report significantly greater dissatisfaction with overall education quality (11.0% in the flexible-policy group and 10.7% in the standard-policy group, P=0.86) or well-being (14.9% and 12.0%, respectively; P=0.10). Residents under flexible policies were less likely than those under standard policies to perceive negative effects of duty-hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education but were more likely to perceive negative effects on personal activities. There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety. Residents in the flexible-policy group were less likely than those in the standard-policy group to report leaving during an operation (7.0% vs. 13.2%, P<0.001) or handing off active patient issues (32.0% vs. 46.3%, P<0.001).
  
  
  CONCLUSIONS
  As 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 residents' satisfaction with overall well-being and education quality. (FIRST ClinicalTrials.gov number, NCT02050789.).
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Karl Y
authors.initials: KY
authors.lastname: Bilimoria
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Jeanette W
authors.initials: JW
authors.lastname: Chung
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Larry V
authors.initials: LV
authors.lastname: Hedges
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Allison R
authors.initials: AR
authors.lastname: Dahlke
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Remi
authors.initials: R
authors.lastname: Love
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Mark E
authors.initials: ME
authors.lastname: Cohen
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: David B
authors.initials: DB
authors.lastname: Hoyt
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Yang
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: John L
authors.initials: JL
authors.lastname: Tarpley
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: John D
authors.initials: JD
authors.lastname: Mellinger
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: David M
authors.initials: DM
authors.lastname: Mahvi
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Rachel R
authors.initials: RR
authors.lastname: Kelz
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Clifford Y
authors.initials: CY
authors.lastname: Ko
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: David D
authors.initials: DD
authors.lastname: Odell
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Jonah J
authors.initials: JJ
authors.lastname: Stulberg
authors.affiliation: From the Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L., A.D.Y., D.M.M., D.D.O., J.J.S.), and the American College of Surgeons (K.Y.B., M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern University, Evanston (L.V.H.), and the Department of Surgery, Southern Illinois University, Springfield (J.D.M.) - all in Illinois; the Department of Surgery, Vanderbilt University, Nashville (J.L.T.); the Department of Surgery and the Center for Surgery and Health Economics, Perelman School of Medicine, University of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) - both in Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles (C.Y.K.).
authors.forename: Frank R
authors.initials: FR
authors.lastname: Lewis
mesh_terms: D000068:Accreditation; D003266:Continuity of Patient Care; D004503:Education, Medical, Graduate / Q000592:standards; D005221:Fatigue; D013502:General Surgery / Q000193:education*; D006739:Hospital Administration; D006801:Humans; D007396:Internship and Residency / Q000458:organization & administration*; D007588:Job Satisfaction; D061214:Patient Safety; D010561:Personnel Staffing and Scheduling; D011183:Postoperative Complications / Q000453:epidemiology* / Q000401:mortality; D013514:Surgical Procedures, Operative / Q000401:mortality; D014481:United States; D014940:Work Schedule Tolerance; D016526:Workload / Q000592:standards*