Patients suffered no additional harm when doctors training to be surgeons were allowed to work longer shifts, a study published Tuesday concludes. The findings provide fresh evidence for medical educators looking to relax the strictest limits on resident hours.
The study in the New England Journal of Medicine comes as the Accreditation Council for Graduate Medical Education is reassessing requirements that prevent residents from working extremely long stretches or back-to-back shifts. Those rules were enacted in 2003 and strengthened in 2011 amid concerns that sleep-deprived residents were more likely to make serious errors.
Since then there has been pushback from residency program directors concerned that the rules created new dangers for patients by abruptly forcing interns to leave in the middle of treating a patient or performing surgery. They also complain the rules interfere with resident education because it is harder for trainees to follow their patients.
The study released Tuesday conducted a direct experiment by tracking patient outcomes after loosening the rules for doctors in 58 surgical residency programs. It found that their patients didn't die or suffer complications any more often than at 59 residency programs that stuck with the current rules.
"We believe the trial results say it's safe to provide some flexibility in duty hours," said Dr. Karl Bilimoria, the main author and a professor of surgery at the Feinberg School of Medicine at Northwestern University in Chicago.
Some previous studies had come to similar conclusions, but this one has been anticipated because of its more rigorous methods. The trial has drawn protests from Public Citizen and the American Medical Student Association, which said researchers put patients and residents at risk by waiving the rules.
The groups assert that the experiment, funded by the American Board of Surgery, the American College of Surgeons and the accreditation council, was never likely to find a significant difference in patient outcomes, since most elements of patient care — the physicians, specialists, nurses and other clinical workers — remained unchanged.
"Research on the deleterious effects of chronic sleep deprivation is just overwhelming," said Dr. Deborah Hall, president of the medical student association. "I'm concerned we're going to walk away from a lot of progress that's been made without overwhelming data [showing] that residents aren't subject to the ordinary limits of human neurobiology."
In an editorial also published in the journal, Dr. John Birkmeyer, chief academic officer at Dartmouth-Hitchcock, a health system in New Hampshire, came to a different conclusion than Bilimoria. Birkmeyer wrote that the experiment "effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in continuity of care."
Rather than roll back the rules on duty hours, he argued that surgeons should find safer ways to treat patients without relying on "overworked" residents.
"To many current residents and medical students, 80-hour (or even 72-hour) workweeks and 24-hour shifts probably seem long enough," Birkmeyer wrote. "Although few surgical residents would ever acknowledge this publicly, I'm sure that many would love to hear, 'We can take care of this without you. Go home, see your family, and come in fresh tomorrow.' "
The research was conducted in the academic year that began in the fall of 2014. One group of residency programs followed the existing rules, while the other programs were allowed to remove several strictures.
Residents in the experimental group could stay at the hospital longer than 28 hours in a row, the current maximum. They did not have to be given at least eight hours off between shifts. Residents who worked a 24-hour shift no longer had to wait 14 hours before returning to the hospital. And first-year residents could work more than 16 hours in a row, a limit set in 2011.
After analyzing medical records for 65,849 patients in the control group and 72,842 in the experimental group, the researchers found no significant difference in death or complication rates. They also surveyed 4,330 general surgery residents and found that those with the more flexible schedules rated their overall well-being and morale no different than did those with strict rules.
"We're very encouraged by the findings," said Dr. Maya Babu, a neurological surgery resident at the Mayo Clinic and president of the Resident and Associate Society of the American College of Surgeons. "We feel very strongly that flexibility is important to provide opportunities to learn and to have patient ownership, to see patients from the time they're admitted through surgery the next day."
Seven percent of residents exempted from the duty limitations said they left during an operation at least once a month, while 13 percent of those following the rules said they left. Thirty percent of the experimental group said they missed an operation at least once a month, while 42 percent of those with standard rules said they missed one. A third of the test group said they turned a patient over to another doctor in the middle of dealing with them, while nearly half of the control group recalled doing so.
Dr. Michael Carome, director of Public Citizen's Health Research Group, a patient safety advocacy organization, said the study should have objectively assessed the hours residents worked and the effects on their health and patients, rather than rely on surveys. He said the study also didn't track whether residents in the control group adhered to the stricter limits on how long they could work.
"The study didn't collect any meaningful data on resident health outcomes," Carome said.
The most major restrictions on resident duty hours put into place in 2003, such as a maximum workweek of 80 hours a week and a minimum of one day off every seven, were not tested in the study and are expected to remain in place.
The paper was scheduled to be presented Tuesday at the Academic Surgical Congress in Jacksonville, Fla. A similar experiment, looking at internal medicine residents, is still in progress.
Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Jordan Rau is on Twitter: @jordanrau.
AUDIE CORNISH, HOST:
Here in the U.S., doctors in training work a lot of hours but probably not as many as they would have just over a decade ago. In 2003, limits were placed on the number of hours medical residents can work, and more restrictions were added in 2011. Now some surgeons are pushing back, saying the rules are overly strict. And this week, a study published in the New England Journal of Medicine offers data to support their cause. Now, here to talk about this study with us is Jordan Rau. He's senior correspondent at Kaiser Health News. Welcome to the studio.
JORDAN RAU: Thanks for having me.
CORNISH: OK, Jordan, so tell us a little bit more about this debate, which, I gather, has a lot to do with this idea of sleep deprivation and the potential for medical errors.
RAU: Residents used to work about 110 hours or even more a week. I mean, they practically lived at the hospital. And the concern became that if they were working that much and they weren't getting sleep, they were going to make a lot of unforced errors and mistakes and it was hurting patients. So new rules were put in place and strengthened over time, and those rules limited the amount of time that they could work to 80 hours a week on average. And within that, the residents could only work about 28 hours straight, and then they had to take a break.
But surgeons became concerned about it for a couple of reasons. One is, the surgeons who oversaw those residents - it's - was harder to organize, harder to manage the care. There was also concern about the educational part, which was that the residents wouldn't be able to follow a patient from the time that they were admitted through if they were having surgery the next day and just really see and learn the whole course of care. And then the third concern was called the handoff, which is if the doctor or resident had to leave because their shift was over and was a firm stop, the resident would have to just stop caring for that patient, give it to another resident or doctor who was not familiar with the case up to them and that that might be dangerous for patients.
CORNISH: OK. So along comes this New England Journal of Medicine study, and what are these findings saying?
RAU: Well, the study looked at 117 surgical residency programs, and it was an experiment. Half of those residency programs kept on doing the things that they were doing with these limits in place. And the other half were freed from most of the limits. And after a year, they took a look at what the results were on the patients, and they found that between the two groups, there was no substantial difference in patient deaths or patient serious complications so that the group that had loosened the rules and were presumably working longer were not causing any excessive harm to the patients.
CORNISH: So how does this change the debate or bring people to any kind of consensus about whether residents should be allowed to work longer hours?
RAU: Well, this gives more statistical fuel to the argument that maybe the rules aren't necessary to protect patients. But there's some skepticism about the pushback because residents are cheap labor and getting them to work longer is more convenient for the surgeons and cheaper for the hospital. And there's still some concerns about the underlying issue, which is that if you're sleep-deprived, you're going to make mistakes. And maybe they're not to the extent of killing the patient, but they can still be substantial or important mistakes.
CORNISH: Is this about more than sleep?
RAU: It's not just sleep. I mean, for the one thing, there's an element of pride in the medical culture that doctors can pull these crazy long hours and that they are able to do that and retain their facilities. And in some types of surgery, it's really important to be able to do that because they're very, very long.
But beyond that, it's part of a broader shift, which is that doctors used to have full autonomy and full control over their lives. And there's a move towards making them, you know, more shift workers that are employed by hospitals and they work at set hours. Doctors are now being measured on the quality of their care by insurers and other people. They're not used to be second- guessed. And so there's some concern that you don't want to treat doctors as if they were just, you know, industrial line workers. But on the other hand, the reality of health care is that it's becoming more of a team effort, and it's not just sort of the sole practitioner overseeing all aspects.
CORNISH: That's Jordan Rau. He's senior correspondent with Kaiser Health News. Thanks so much for coming in.
RAU: Thank you. Transcript provided by NPR, Copyright NPR.