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Surgical residents who were allowed some flexibility within their 80-hour work week, compared with residents in standard duty hour-limits, did not have worse patient outcomes or greater dissatisfaction with their education, researchers reported.

A noninferiority trial testing standard versus flexible shift-limits for surgical residents found that rigid time restrictions for shifts and time between shifts did not result in improved rates of patient death or serious injury (9.1% versus 9.0%, P=0.92), reported , of Northwestern University in Chicago, and colleagues, in a presentation at the .

Surgical residents in the flexible programs were also less likely to have to leave in the middle of a surgery (7.0% versus 13.2%) or while caring for a patient having active issues (32.0% versus 46.3%), the researchers wrote in the , where the findings were simultaneously published.

"The study was developed due to persistent concerns in the surgical community," Bilimoria said during a meeting conference. "There was concern that the restrictions inhibited continuity of care. The key mode of restrictions was forcing residents to leave in the middle of surgeries."

Bilimoria said that the American College of Surgeons (ACS), the American Board of Surgery (ABS), and the Accreditation Council for Graduate Medical Education (ACGME) came together to gather better data on surgical residency hours to guide policymakers.

"The study was designed to be a 1-year study, but certainly we need to continue to monitor results," Bilimoria told 乌鸦传媒, adding that "the flexible arm continued throughout the year and we repeated the survey 18 months into the trial."

"If the ACGME does change duty policies in July, we'll continue to monitor patient outcomes for the next 5 years," he said.

But Bilimoria said he believed the 80-hour work week limit should stay in place.

The current Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial, "effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care," wrote , of Dartmouth-Hitchcock Medical Center in Lebanon, N.H., in an . "Rather than backtrack on the ACGME duty-hour rules, surgical leaders should focus on developing safe, resilient health systems that do not depend on overworked resident physicians."

"The authors conclude, as well many surgeons, that surgical training programs should be afforded more flexibility in applying work-hour rules," Birkmeyer wrote. "This interpretation implicitly places the burden of proof on the ACGME."

Birkmeyer noted that the patients who would most likely be affected by resident handoffs -- -- those with acute or deteriorating clinical conditions -- represent only a small percentage of surgical patients at teaching hospitals. "It is not surprising that outcomes did not vary according to whether programs adhered to ACGME requirements on maximum shift length and time off between shifts."

FIRST split 115 surgical residency programs at 148 affiliated hospitals into two groups for a noninferiority trial to test duty-hour rules. Both groups adhered to an 80-hour work week, but group one was allowed to waive four of the ACGME rules concerning shift-length and time-off between shifts, while group two maintained standard duty-hour limits.

The trial ran from July 2014 through June 2015, and included 4,330 residents.

Bilimoria's team looked at the 30-day rate of postoperative death or serious complications for 138,691 patients. The noninferiority margin was measured at an absolute difference of 1.25 percentage points.

The rate of death or serious complication was 9.1% in the flexible-policy group, and 9.0% in the standard group (P=0.92). The risk did not differ between groups either (adjusted odds ratio 0.96, CI 92% 0.90 to 1.04, P=0.38).

The ABS In-Training Examination (ABSITE) resident survey was given half-way through the trial year during the standard administration.

Compared with residents in standard-policy programs, flexible-policy residents were not more likely to report dissatisfaction with their overall education quality (OR 1.08, 95% CI 0.77-1.52, P=0.64), but they did report slightly higher dissatisfaction with overall well-being (OR 1.31, 95% CI 0.99-1.74, P=0.06).

Flexible-policy residents were less likely to report being dissatisfied with continuity of care compared with standard-policy students (OR 0.44, 95% CI 0.32-0.60, P<0.001), with the quality and ease of handoffs and transitions in care (OR 0.69, 95% CI 0.52-0.92, P=0.01), with having to leave during an operation (OR 0.46, 95% CI 0.32-0.65, P<0.001), and with handing off patient with active issues (OR 0.53, 95% CI 0.45-0.63, P<0.001).

However, the flexible-policy students were more likely to report being dissatisfied with time for rest compared with standard-policy residents (OR 1.41, 95% 1.06-1.89, P=0.02).

The resident surveys did not find a difference between groups with regard to satisfaction over duty-hour regulation (OR 0.99, 95% CI 0.71-1.40, P=0.97).

"They had a better training experience in many ways," Bilimoria said. "In terms of well-being, they noted that the flex duty policy did have some impact on time with friends and family, but when asked about satisfaction, they did not report lower rates. They understand that there are trade-offs for this important work."

This study was not blinded, and no data were collected on duty-hour logs, sleep, on-call schedules, hand-off protocols, or adherence to policies that were not changed during the trial. Other study limitations were a lack of programs that were not affiliated with (NSQIP), and no data on nonsurgical residency programs.

The FIRST study and a similar trial still underway called iCOMPARE have been attacked as unethical. Last year, the consumer group Public Citizen and the American Medical Students Association wrote to the Department of Health and Human Services and to the ACGME demanding that iCOMPARE be halted and that participating institutions be sanctioned.

The groups said the extended hours allowed in the trials would put students and patients at risk for a variety of adverse outcomes. Moreover, because both were cluster-randomized in nature, neither the students nor the patients were allowed to opt out.

An ACGME official denied the allegations, saying that the protocols' protections (such as the mandatory rest periods) would not raise risk of adverse outcomes -- although these were nevertheless tracked in FIRST.