Surgical Residents' Shift Length Not a Factor in Patient Safety

Concern that duty hour restrictions inhibit the ability of surgical residents to care for patients prompted researchers to design a trial to test the efficacy of duty hour policies.

Giving surgical residents the choice to work longer shifts or take less time off between shifts does not create greater risks of health complications or death for their patients, according to a study in Tuesday's edition of The New England Journal of Medicine.

The first-ever national randomized trial of resident duty hours involving 117 general surgery residency programs and 151 hospitals found that less-restrictive policies are safe for patients, reduce complications arising from handoffs, and increase resident satisfaction, said study author Karl Bilimoria, MD. He is a faculty scholar at the American College of Surgeons and director of the Surgical Outcomes and Quality Improvement Center at Northwestern University Feinberg School of Medicine in Chicago.

"The study was developed due to persistent concerns in the surgical community because of the duty hour restrictions that had been implemented in 2003 and 2011," Bilimoria said in a conference call with media on Tuesday.

"There was concern that the restrictions actually inhibited continuity of care, or the ability of doctors to care for their patients [by] having to hand off care at inopportune times. The cumulative restrictions were forcing residents to leave in the middle of operations, or while stabilizing patients in the in the intensive care unit. Clearly that is bad for patients, but it is also bad for resident training."

The Accreditation Council for Graduate Medical Education in 2003 limited residents' work hours to 80 per week, capped overnight shift lengths, and mandated minimum time off between shifts. In 2011, ACGME further shortened shift lengths for first-year residents and increased residents' time off after a 24-hour shift.

The FIRST Trial
With the support of ACGME, the American Board of Surgery, and the American College of Surgeons, Bilimoria and his colleagues developed the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial to test the efficacy of these duty hour policies.

The study randomly assigned general surgery residency programs to use one of two types of duty hour policies during the academic year from July 1, 2014, to June 30, 2015. Both groups adhered to three main ACGME rules: The workweek was limited to 80 hours; one day off in seven was required; and residents could not take call more often than every third night.

A total of 117 programs at 151 hospitals completed the study.

One group of 59 programs and 71 hospitals participated in "Standard Policy," with all existing ACGME duty hour policies. 

The other "Flexible Policy" group of 58 programs and 80 hospitals got permission from the ACGME to waive rules on shift lengths and time off between shifts. Interns could work beyond the maximum of 16 hours; more senior residents' duty hours could exceed 24 hours; residents were not required to have at least eight hours off between shifts; and residents were not required to have at least 14 hours off after 24 hours of continuous duty.

Results
With the study groups in place, FIRST found that surgical patients' complication rates in the first postoperative month were not affected by less-restrictive duty hours. Among nearly 139,000 patients treated, the rate of this composite outcome was similar in both groups, at 9%. There were no group differences for the 10 other patient outcomes studied, including the need for an unplanned second operation.

"The study found that when we looked at patient outcomes between the two study arms, we found that there was no difference in patient safety in surgical patients," Bilimoria says. "We investigated this in a number of ways and for a number of different complications and continued to find no difference."

Reaction
In addition, 2,220 residents who were in the flexible hours program reported in a survey accompanying the study that they were not more likely to be dissatisfied with their residency experience, nor to report negative effects of fatigue on themselves or their patients when compared with the 2,110 residents in the standard group.

"We were very interested in the residents' perspective," Bilimoria says. "The residents noted striking improvements in patient safety and continuity of care, and the ability to stay in an operation that they started, or to operate on patients that they were taking care of, or to stay and stabilize patients at critical moments."

"In terms of wellbeing, they noted that the flexible duty hours had some effect on their time with their family and friends, time for hobbies and such. But when you asked if they were dissatisfied, they answered that there was no difference and they were not particularly dissatisfied, which makes sense. We see that in a lot of professions, where people understand the trade-offs with activities outside of work in exchange for working in their profession."

Reaction to the study was mixed.

The Resident and Associate Society of the American College of Surgeons, which represents more than 13,000 surgical trainees, said in a media release that the study was needed "to inform surgical resident duty hour policy. Up until now, there has not been high-level prospective evidence on this important issue."

"Based on the trial's results, the RAS-ACS firmly believes that flexibility in duty hours is not only safely possible, it is essential to provide surgical residents with exposure to the variety and complexity of educational experiences necessary to become fully trained and competent surgeons," RAS-ACS said.

The reception was not so cordial at the Public Citizen Health Research Group, which had filed a complaint against the study in November, and which this week issued a scalding critique of the "unethical clinical trial" and of NEJM for violating its own guidelines.

"The NEJM editors' decision to publish the results of the unethical, seriously flawed FIRST trial violates the journal's own policy requiring authors to provide assurances related to the protection of human subjects," PCHRG wrote.

"Furthermore, as Public Citizen and the American Medical Student Association predicted in their November complaint letter to the Office for Human Resource Protections, the trial yielded the self-serving results sought by the trial's researchers, whose stated goal before the trial began was to roll back the ACGME's 2011 mandatory limits on physician resident work hours that were adopted to protect both the residents and their patients from serious harm."

'Unfounded' Complaints
Bilimoria dismissed the complaints as "unfounded and not reasonable, quite frankly."

"Their main issues focus on whether there is a reason to even do such a trial," he said. "To us there is total reason to do a trial, and the question is around equipoise. Is there balance around the two study arms in terms of risks to patients, residents, and everyone involved?"

"If you look at the prior data before this trial in surgery, most of it suggested that patient outcomes worsened after the 2003 duty hour reforms," he continued. "Not only is there equipoise, there is an imperative to study the question to make sure the policy reforms of 2003 and 2011 are not endangering patients and residents."

"To us," said Bilimoria, "the concept of whether the trial is ethical just doesn't make sense."