(Reuters Health)—Whether surgical trainees should be able to work long shifts is a matter of fierce debate, and the methods of a controversial study aimed at answering that question were outlined in a top surgical journal.
The results won’t be available until February. In the meantime, critics of the study say it exposed residents and their patients to unnecessary risks by extending work hours. But supporters say the study did not increase risk and will lead to policies backed by evidence.
Public concern surrounding residents’ work hours led the Accreditation Council for Graduate Medical Education (ACGME) to impose restrictions in 2003 and again in 2011. Current policy limits the workweek to a maximum 80 hours, regulates mandatory time off between shifts and limits on-call periods.
Until now, however, there had been no randomized controlled trials to confirm that long or short shifts are beneficial or harmful for residents or patients. Only lesser-quality evidence from observational studies existed.
As reported online Dec. 30 in JAMA Surgery, the new Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial involved residents from 117 training programs. In all the participating programs, in accordance with ACGME rules, work weeks were still limited to 80 hours, residents still had one day off per week and they weren’t on call more often than every third night.
In half the programs, however, three ACGME rules were eliminated. First-year residents’ shifts weren’t limited to 16 hours. For more advanced residents, shifts weren’t limited to 28 hours. And there was no guarantee of at least 14 hours off after a 24-hour shift or at least eight hours off after a regular shift.
In a Nov. 19 letter to regulators, the consumer advocacy group Public Citizen and the American Medical Student Association raised concerns over the trial and over a similar study, iCOMPARE, being conducted with internal medicine residents.
The organizations took issue with the institutional review board (IRB) at Northwestern University in Chicago, where researchers are heading up the study, because it ruled the study did not constitute research with human subjects and so did not require the supervision typical of clinical trials.
Dr. Sidney Wolfe, senior advisor of Public Citizen’s Health Research Group, told Reuters Health that doctors and patients were not given the chance to agree or decline to participate in the research.
“Some surgeons may want to do it but others may not want to do it,” Wolfe says.