Longer shifts for surgical residents and less rest in between do not affect a key measure of patient safety for the worse or demoralize trainees, according to a controversial study published online February 2 in the New England Journal of Medicine (NEJM). The massive randomized trial, which involved 117 general surgery residency programs during the 2014-2015 academic year, represents an effort to loosen duty-hour restrictions introduced over the past 13 years by the Accreditation Council for Graduate Medical Education (ACGME). The rules were designed to avoid overworking residents into stupors and exposing patients to clinical mishaps. However, groups such as the American College of Surgeons (ACS) say shorter shifts degrade not only continuity of care — think more frequent patients hand-offs — but also resident training, because it's harder to see a case to the end, for example. Last year, the consumer watchdog group Public Citizen and the American Medical Student Association faulted this study — known as FIRST— and a similar one on longer shifts for putting residents and patients alike in harm's way and failing to obtain informed consent from them in the process. This week, Public Citizen turned up the heat by charging NEJM with breaking its own editorial policies by publishing the FIRST study even though its human subjects were not afforded proper protection.NEJM is standing its ground. "We believe the study was conducted in an ethical fashion," a spokesperson told Medscape Medical News. Less Than 8 Hours Rest Between Shifts for Some Trainees FIRST, which stands for Flexibility in Duty Hour Requirements for Surgical Trainees, received funding from the ACS, ACGME, and the American Board of Surgery (ABS). The executive directors of the ACS and ABS numbered among the study's many authors. The 117 residency programs that participated were in 151 hospitals. They included big names such as Brigham and Women's Hospital and Massachusetts General Hospital, both in Boston; Johns Hopkins Hospital, in Baltimore, Maryland; the Mayo Clinic Hospital (both campuses), in Rochester, Minnesota; the University of California, San Francisco, Medical Center; and Vanderbilt University Hospital, in Nashville, Tennessee. Half the residency programs were assigned to a "standard-policy" group that followed ACGME duty-hour rules. The other half comprised the "flexible-policy" group. Both groups had to observe a chief reform introduced in 2003 — residents could not work more than 80 hours a week averaged over 4 weeks. And no matter the group, residents had to have 1 day off every 7 days, and not be on call more frequently than every third night. The flexible-policy group, however, could waive four other ACGME requirements on shift length and intervening rest periods. First-year residents could log more than the 16 hours maximum in the standard-policy group, and all other residents could exceed the 28-hour limit. The flexible-policy group also didn't have to schedule residents for the minimum 8 hours off between shifts that ACGME stipulates, or give them at least 14 hours off after they worked 24 hours in a row. Fewer Missed Surgeries, More Grumbling About Lost Personal Time The study authors, led by Karl Bilimoria, MD, a professor of surgery at Northwestern University in Evanston, Illinois, wanted to see how the residency programs with flexible hours compared with the standard-policy group in terms of patient safety. Their primary measure was the rate of surgery patients dying or developing serious complications within 30 days. On this yardstick, there was practically no difference between the standard-policy group (9.0%) and the flexible-policy group (9.1%). This state of parity persisted whether surgery was emergent or elective, inpatient or outpatient, or high risk or not high risk. And in secondary patient outcomes such as sepsis, unplanned reoperations, and surgical site infections, the two groups also posted similar numbers. "These findings suggest that flexible duty hour policies appear to be safe for patient care," Dr Bilimoria and his coauthors wrote. The authors also surveyed residents midway in the 2014-2015 academic year to find out their thoughts about duty hours, and primarily, the overall quality of training and their overall well-being. The study found that residents in flexible-policy programs were not significantly more likely to be dissatisfied with their educational experience than their counterparts in the standard-policy programs (11.0% versus 10.7%, respectively). Dissatisfaction with overall well-being was roughly equal as well — 14.9% for the flexible-policy group versus 12.0% for the standard-policy group. Drilling deeper into secondary issues, the study found some significant differences between residents in the two groups. Those in the programs that allowed longer shifts were less likely to perceive negative impact of their duty hours on patient safety, continuity of care, and training issues such as acquiring operative skills. They also were less likely to report leaving in the middle of an operation, missing one, or handing off an active patient issue. These same residents, however, were more likely to be dissatisfied with the impact of longer shifts on time with family and friends, extracurricular activities, rest, and health. Residents in both groups were asked if fatigue always or often affects personal safety, and patient safety. The vast majority in both groups said no, and there was no significant difference between the groups for residents who answered yes. "Putting Up a Smokescreen" To Public Citizen, the findings of FIRST were ones that the authors set out to reach for the sake of rolling back limits on resident duty hours. The consumer watchdog group alleges many methodological flaws in the study that, in its opinion, yielded preordained conclusions. It points out, for example, that FIRST chose not to collect any data on needle sticks that sleepy residents experience, or car accidents on the way home from work. The study explained that those are "notoriously challenging outcomes to capture in surveys." "They're just putting up a smokescreen," said Michael Carome, MD, the director of Public Citizen's Health Research Group, in an interview with Medscape Medical News. Dr Carome said that researchers could have asked residents simply to log such mishaps on a website. Dr Carome's biggest complaint, however, is that the study failed to obtain informed consent from both patients and residents. Whether it was necessary in the first place is a matter of debate. The institutional review board (IRB) of Northwestern University, where lead author Dr Bilimoria works, deemed FIRST exempt from the usual consent protocols because the intervention was at the hospital level. That is, the study randomized training programs and their hospitals, not individual residents and patients. In addition, the Northwestern IRB did not consider FIRST to be "human subjects research." "Who decided to participate or not were institutions," Dr Bilimoria told Medscape Medical News. And at that level, humans were solicited for consent — among them, residency program directors, surgery chairs, and graduate medical education committees. "We had signatures from 600 to 700 people," he said. Dr Carome doesn't buy that explanation, given that the study delved into both patient safety and resident well-being. "It's completely clear that this is human subject research," he said. "It's alarming that the [NEJM] would accept this statement [by Dr Bilimoria] and let it be published." A perspective piece in the same issue of NEJM supported the decision not to obtain informed consent from residents in FIRST. Lisa Rosenbaum, MD, a national correspondent for the journal, wrote that requiring residents' consent "would render the results uninterpretable, given the selection bias that would be introduced if those preferring longer hours were more likely to participate." Residents Understand the Trade-off, Says Lead Author In defense of his study, Dr Bilimoria stressed the need to answer the burning question of whether duty-hour restrictions improved patient care as their advocates said they would. "All the prior literature suggested we may have made outcomes worse," he said. There was high demand for FIRST, according to Dr Bilimoria. None other than the Institute of Medicine had recommended extensive, specialty-specific studies on the relationship between resident duty hours and patient safety. And almost all of the residency programs and hospitals that were eligible for the study signed up, he noted. Like others, Dr Bilimoria said that many residents want the chance to put in more hours if it means staying through the end of a surgery or stabilizing an ICU patient. He acknowledged that residents in the flexible-policy programs were more likely to be dissatisfied with the effects of their schedules on their private lives. "However, there was no difference in overall personal satisfaction," he said. "They understand that there's a trade-off," said Dr Bilimoria, "between extracurricular activities and family life and the obligations in your profession to get good training and take care of your patients." In an accompanying editorial in NEJM, general surgeon John Birkmeyer, MD, reached a different conclusion than Dr Bilimoria. "The FIRST trial effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care," wrote Dr Birkmeyer, the chief academic officer and an executive vice president at Dartmouth-Hitchcock Medical Center in New Hampshire. Instead of relaxing ACGME restrictions on duty hours, he said, surgical leaders should advocate for "safe, resilient health systems that do not depend on overworked residents. "Although few surgical residents would ever acknowledge this publicly, I'm sure many of them would love to hear, 'We can take care of this case without you. Go home, see your family, and come in fresh tomorrow.' " Dr Bilimoria reported receiving grants from the ACS, the ABS, and the ACGME for the study. He also reported receiving an honorarium from the ACS in the last 3 years. Dr Birkmeyer reported serving on a board of directors of a healthcare analytics company he cofounded called ArborMetrix. Dr Rosenbaum reported no relevant conflict of interest. Source
