Researchers describe controversial study of surgeon training

(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 Wednesday in a top surgical journal.

The results won’t be available until February. In the meantime, critics of the study say it exposed doctors-in-training - known as 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 work week 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 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 8 hours off after a regular shift.

In a November 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 said.

The trial’s lead investigator, Dr. Karl Bilimoria of Northwestern, said that while FIRST wasn’t classified as human research, an independent data monitoring board was established to check for safety concerns.

He added that aside from programs in New York, which regulates resident hours by law, only six sites declined to participate. All sites were free to run the trial through their individual IRBs.

“We left it up to everybody to do what was best for them locally,” he said.

In a letter to Public Citizen and the American Medical Student Association, ACGME noted that tired residents can hand off patients at any time, are advised to nap after 16 hours and are given adequate sleep facilities and/or safe transportation options.

Two JAMA editors, Drs. Julie Ann Sosa and Howard Bauchner, write in a commentary published with the paper, “We recognize the controversy about the ethics of the study and believe that transparency about the way in which it was approved and conducted should be reviewed and discussed.”

The ethical issues are complex, agreed Dr. Robert Klitzman, director of the Masters of Bioethics Program at Columbia University in New York City.

He noted that a 2014 report in JAMA showed no improvement in patient outcomes after the 2011 ACGME resident hour restrictions were imposed. While he’s sympathetic to the concerns of Public Citizen, Klitzman said, “I think it’s very powerful evidence that there was no danger to patients” before then.

He agrees with Public Citizen and the American Medical Student Association, however, that the trial should be considered human research.

“It’s much more complicated than a short shift and long shift,” said Dr. Sanjay Desai, residency program director at Johns Hopkins Hospital in Baltimore.

For example, he said, shorter shifts lead to more transitions or “handoffs” in care, which are known to contribute to miscommunication and errors.

Desai, who is not involved with FIRST but is involved with iCOMPARE, also said shorter shifts are often worked at night and can be as tiring as longer shifts.

“The logic of the argument makes sense only at the surface, but when you consider night shifts and handoffs, the complexity becomes immediately clear,” Desai said.

Although the study is done, Klitzman said the Office for Human Research Protections, which was contacted by Public Citizen and the American Medical Student Association, may still take action or decline to act on the complaint.

SOURCE: and JAMA Surgery, online December 30, 2015.