National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training

There have been long-standing concerns over possible fatigue-related errors in clinical care delivered by residents working long hours. Such concerns about patient safety and resident well-being led the Accreditation Council for Graduate Medical Education (ACGME) to introduce national regulations in 2003 limiting resident duty periods to 80 hours per week, mandating minimum time off between shifts, and capping overnight shift lengths. Due to persisting concerns, the ACGME implemented further restrictions in 2011 that shortened maximum shift lengths for interns and increased time off after overnight on-call duty for residents. The benefit of these duty-hour reforms on patient outcomes, resident education, and resident well-being is unclear. Although most observers agree that some duty-hour regulation was necessary, critics of these ACGME reforms cite a weak evidence base for the 2003 and 2011 reforms. A number of retrospective studies and systematic reviews have questioned whether duty-hour reforms achieved their intended goals. Most studies conducted in surgical settings found no difference or a worsening in patient postoperative outcomes and resident education after implementation of duty-hour reforms. Restrictions imposed on surgical residents may reduce continuity of care and increase the frequency of handoffs, jeopardizing patient safety. Moreover, forcing residents to leave at critical times may undermine the goals of surgical training among residents unable to follow patients through critical aspects of their care. No evidence is available from large, prospective, randomized trials to inform duty-hour regulations. The investigators designed the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial to compare standard ACGME duty-hour policies with flexible duty-hour policies with respect to patient safety and resident well-being. The FIRST trial is a prospective, cluster-randomized, pragmatic, noninferiority trial conducted from July 1, 2014, to June 30, 348 Obstetrical and Gynecological Survey Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. 2015 at 117 ACGME-accredited general surgery residency programs and 151 affiliated hospitals. Programs were randomly assigned to 2 groups. Programs assigned to the standard-policy group continued adherence to existing ACGME duty-hour policies, whereas programs assigned to the flexible-policy (intervention) group were allowed policies that waived rules on maximum shift lengths and time off between shifts. The primary outcome measure was the 30-day rate of postoperative death or serious complications. Secondary outcomemeasures were other postoperative complications as well as resident satisfaction and perceptions regarding their well-being, education, and patient care. Data were analyzed from 138,691 general surgery patients: 65,849 in the standard-policy group and 72,842 in the flexiblepolicy group. No significant difference was found between study groups in the rate of death or serious complications: 9.1% in the flexible-policy group and 9.0% in the standard-policy group, P = 0.92. Survey data were obtained from 4330 general surgery residents undergoing training in the 117 programs (2110 in the flexible-policy group and 2220 in the standard-policy group). Residents assigned to the flexible policy program did not have significantly greater dissatisfaction with either 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 in the flexible-policy group were less likely than those in the standard-policy group to perceive negative effects of duty-hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education. However, flexible-policy residents were more likely to perceive negative effects on personal activities such as time with family and friends, time for extracurricular activities, rest, and health. No significant differences between study groups were found in resident-reported perception of the effect of fatigue on personal or patient safety. Flexible-policy residents were less likely than standard-policy residents to leave during an operation (7.0% vs 13.2%, P < 0.001) or hand off active patient issues (32.0% vs 46.3%, P < 0.001) at least once in the past month. These findings demonstrate that flexible, less-restrictive duty-hour policies for surgical residents are noninferior to standard ACGME duty-hour policies with respect to patient outcomes. Moreover, there is no significant difference between groups with respect to residents' satisfaction regarding their overall well-being and education.