Controversial, first-of-its-kind study: Long shifts don't affect patient safety

Some say the study is unethical

Limits on work hours for surgical residents do not improve patient safety, according to the results of the first randomized controlled trial on the subject, published this week in New England Journal of Medicine.

The study has been controversial—the American Medical Student Association (AMSA) said it unethically put patients and residents at risk. But others have argued that the work-hour limits put patients at risk by increasing the number of times a patient changes clinicians.

For the study, researchers divided about 120 surgical programs into roughly two equal groups. Altogether, about 4,330 general surgery residents treated almost 139,000 patients during the 2014-15 academic year.

The control group was subject to the restrictions on residents put in place in 2003 and 2011 by the Accreditation Council for Graduate Medical Education (ACGME), including:

  • 16-hour shift limits for first-year surgeons;
  • 28-hour shift limits for second-year surgeons;
  • A maximum 80-hour work week, averaged over four weeks; and
  • At least eight hours off between shifts, and at least 14 hours off after a 24-hour shift.

Residents in the second group also had an 80-hour work week limit, but they had no shift limits and no required time off between shifts.

No greater risk of complications

The study found that patients in programs without shift limits did not have any greater risk of post-operative complications or death than those in the control group. Further, the residents with the more flexible schedules were only half as likely to miss an operation or transition a patient to another staffer.

"We had residents leaving in the middle of operations and while stabilizing critically ill patients because the clock was up," says lead author Karl Bilimoria, director of the surgical outcomes and quality improvement center at Northwestern Feinberg School of Medicine. "Clearly, that's not good for patient care or for the [residents'] training. They need to be able to see those cases through."

Study draws mixed reactions

Some viewed the study results as evidence that many of the restrictions on residents are unnecessary.

John Birkmeyer, chief academic officer at Dartmouth-Hitchcock, writes in an accompanying editorial that the study "effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in continuity of care."

However, AMSA and the advocacy group Public Citizen both criticized the study's methodology and said the new study does not provide evidence that the restrictions could be lifted without negatively affecting patient safety.

Michael Carome, director of Public Citizen's Health Research Group, says the study "didn't collect any meaningful data on resident health outcomes" and should have relied on more objective assessments of resident work hours and patient outcomes, rather than using surveys.

AMSA president Deborah Hall says, "Research on the deleterious effects of chronic sleep deprivation is just overwhelming." She adds, "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."

ACGME communications manager Emily Vasiliou tells Reuters that the group will consider the study results as part of its ongoing reassessment of the resident requirements (Bernstein/Dennis, "To Your Health," Washington Post, 2/2; Rau, "Shots," NPR, 2/2; Seaman/Emery, Reuters, 2/2).

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