Bilimoria said 129 hospitals have signed up for the study and half will be randomly assigned to follow the Accreditation Council for Graduate Medical Education's 2011 duty-hour regulations. The others will be allowed some flexibility in following the regulations, though they must adhere to the ACGME 80-hour workweek limit (averaged more than four weeks).
These hospitals must also allow residents a minimum of one free day every week (averaged over four weeks). But the group will not be subject to other aspects of the 2011 regulations, such as 16-hour workday limits for first-year residents or a requirement that residents get 14 hours off after a 24-hour shift or eight to 10 hours off after shorter shifts.
Northwestern University is the sponsor of the one-year parallel-assignment trial with the ACGME, American Board of Surgery and American College of Surgeons providing the funding. Hospitals need to be participating in the ACS National Surgical Quality Improvement Program to be eligible for the study, which has been dubbed the FIRST Trial, or Flexibility In duty hour Requirements for Surgical Training.
The ACGME's 2011 resident work-hour regulations generally followed recommendations the Institute of Medicine released in 2008, but they have come under fire for eroding professionalism and developing a “shift-work” mentality in new doctors.
A of resident work-hour studies, co-authored by ACGME CEO Dr. Thomas Nasca, identified eight papers that found that the work-hour limits had no significant effect on surgical residents, two that found the regulations led to small improvements and two that found quality had decreased and led to admission increases for surgical intensive-care units.
“The effect of the limits on safety and quality of care is positive in studies of medical specialties, but negative in surgical specialties,” Nasca and his co-authors wrote. Institutions that have kept up surgical volumes for residents may have done so at the expense of continuity of care outside the operating room, they noted.
“Operative volume alone may be a suboptimal measure for surgical competence, particularly decisionmaking around interventions and managing complications,” they wrote.
Bilimoria said the study's results could be used to shape policy. “There is clearly a need to fill the data void,” he said. “I'm not really concerned which way the results go. Either way, it will give us useful information.”
The trial will last a year.
Bilimoria scoffed at the notion that physicians in training should be subject to work-hour limits similar to pilots and truck drivers.
“You could have a number of pilots who can step in and fly that plane,” he said. Medicine “is far more complex,” Bilimoria said, adding that the doctor who has been up all night with a patient is probably the best individual to ensure that patient's condition has stabilized.
Bilimoria also dismissed the idea that simulation training can replace time spent in the OR. “I don't think anything substitutes for real-life experience, particularly in surgery,” he said.
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