FIRST Trial: Patients Not Harmed When Surgical Residents Work Flexible Hours

Patients had no greater risk of death or serious morbidity when cared for by surgical residents working flexible duty hours when compared to those working standard Accreditation Council for Graduate Medical Education-mandated hours.

Both resident groups were equally satisfied with the quality of their education and their personal well-being. Residents in the flexible work hours cohort were significantly less inclined to feel that duty hours policies had a negative effect on patient safety, continuity of care, professionalism, or resident education. However, the flexible group residents were significantly less satisfied with the amount of time they had to rest.

These results were from the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial, which was presented this morning at the Academic Surgical Congress in Jacksonville, Florida and published ahead of print in the New England Journal of Medicine today.

The authors randomized 59 general surgery programs and their 71 affiliated hospitals to the standard rigid 80-hour work week schedule and 58 programs having 80 affiliated hospitals to an 80-hour work week with flexible hours. In order for the study to be done, the ACGME waived its four rules regarding maximum shift length and minimum hours off duty between shifts.

“The issue has been hotly debated, but prior to the FIRST Trial, limited data existed…”

Outcomes for the 138,691 patients in the trial were obtained from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database during the year of the study—July 1, 2014 to June 30, 2015.

The response rate for the 4330 residents surveyed about their experiences with the two work hours policies ranged from 84% to 87% for the outcomes in question.

The authors conceded that like most studies, the FIRST Trial had some limitations such as all of the included hospitals had to be participating in the ACS NSQIP, the study’s results are specific to general surgery residents, and the degree of resident compliance with both policies is unknown.

According to lead author Dr. Karl Bilimoria of the Northwestern University School of Medicine, adherence to the policies may not be that important because the study was analyzed according to the intention to treat principle and show what happens in the real world when residents and programs are given flexibility.

Because the residents expressed a few concerns about time off, rest, and health, Dr. Bilimoria thought their responses were candid. “So I believe them when they say continuity of care and patient safety dramatically improved, as did their training,” he said.

The issue has been hotly debated, but prior to the FIRST Trial, limited data existed about what is worse for patient care—tired residents or frequent handoffs of patient information.

Consistent with prevailing thoughts of the surgical community, the trial results suggest that duty hour flexibility is safe for patients and better for resident training.

The question now is will flexible duty hours be permitted for all surgical programs?

“The ACGME has convened a Duty Hours Task Force to evaluate the trial results and prior literature in conjunction with testimony from all involved stakeholders,” Said Dr. Bilimoria. He hopes the trial’s findings will help with their decision.

Skeptical Scalpel is a retired surgeon and was a surgical department chairman and residency program director for many years. He is board-certified in general surgery and critical care and has re-certified in both several times. He blogs at SkepticalScalpel.blogspot.com and tweets as @SkepticScalpel.