JACKSONVILLE, FLA. – Accreditation Council for Graduate Medical Education (ACGME) rules that shortened surgery resident shifts and expanded breaks didn’t improve patient safety or surgery resident well-being in a trial presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
“This national, prospective, randomized trial showed that flexible, less-restrictive duty-hour policies for surgical residents were noninferior to standard ACGME duty-hour policies,” wrote Dr. Karl Bilimoria, associate surgery professor at Northwestern University, Chicago, and associates. The work was published simultaneously Feb. 2 in the New England Journal of Medicine (doi: 10.1056/NEJMoa1515724).
Recent ACGME residency reforms were meant to reduce fatigue-related errors, but there have been concerns that they have come at the cost of increased handoffs and reduced education.
To get a handle on the situation, the investigators randomized 59 teaching-hospital surgery programs to standard ACGME duty hours and 58 others to a freer approach in the 2014-2015 academic year. Residents weren’t allowed to work more than 80 hours per week in either group, but hospitals in the flexible-hour arm were allowed to push residents past ACGME policy, working first-year residents longer than 16 hours per shift and others more than 28 hours, with breaks of less than 14 hours after 24-hour shifts and less than 8-10 hours after shorter ones.
Among the 138,691 adult general surgery cases during the academic year, there was no increase in 30-day rates of postoperative deaths or serious complications in the flexible group (9.1% vs. 9.0% with standard policy, P = .92) or secondary postoperative outcomes, based on risk-adjusted data from the American College of Surgeons’ National Surgical Quality Improvement Program (ACS NSQIP).
The 4,330 residents in the study filled out a multiple-choice questionnaire midway through the project in January 2015. Those in the flexible group said they weren’t significantly unhappier with the quality of their education (11.0% vs. 10.7% in the standard group, P = .86) or well-being (14.9% and 12.0%, P = .10). The investigators didn’t report the lengths of shifts or breaks.
There were no significant differences in resident-reported perceptions of fatigue on personal or patient safety. Residents in the flexible group were less likely to report leaving an operation (7.0% vs. 13.2%, P less than .001) or handing off patients with active issues (32% vs. 46.3%, P less than .001).
Flexible duty-hour residents “noted numerous benefits with respect to nearly all aspects of patient safety, continuity of care, surgical training, and professionalism. However, residents reported that less-restrictive duty-hour policies had a negative effect on [their] time with family and friends, time for extracurricular activities, rest, and health. Importantly … residents’ satisfaction with overall well-being did not differ significantly between study groups,” Dr. Karl Bilimoria and associates concluded.
The investigators “did not specifically collect data on needle sticks and car accidents, because these are notoriously challenging outcomes to capture in surveys,” they noted.
In an interview, Dr. Bilimoria commented, “Increasingly over time we’ve had more regulations of duty hours, and with each set of regulations the surgical community became increasingly concerned about patient handoffs and continuity of care, so our focus was to identify those policies that we thought affected continuity of care and work with the ACGME to waive those for the centers that were in the flexible arm of the study.”
His comments on the impact on residents: “The residents very clearly noted that the flexible policy arm provided better continuity of care, allowed them to take care of their patients in a way that they wanted to and stay with their patients in the operating room and at times when their patients were unstable.”
When asked if the findings could be extrapolated to these smaller nonparticipating centers, Dr. Bilimoria responded, “We captured the majority of residents, and we’re working on an analysis now that seeks to understand what the generalizability would be to those nonparticipating programs. That will be fairly enlightening as well.”
“95% of eligible programs participated in the trial, showing overwhelming support from the community for bringing high level data to this question. There had never before been a randomized trial nationally on this topic and for understanding and testing the notion of flexibility. They saw a need for both of those things.”
ACGME paid for the work, along with the American Board of Surgery and the American College of Surgeons. Dr. Bilimoria and five other authors reported payments from ACGME and the other entities.
UPDATE: This story was updated 2/2/16