No Patient Harm with Longer Duty Hours, According to FIRST Trial

By Jill Drachenberg, Managing Editor

The results of the controversial Flexibility in Duty Hour Requirements for Surgical Trainees Trial (FIRST) trial have been published and show that patients suffered no additional complications when physicians and surgeons in training are allowed to work longer shifts.

The FIRST trial was conducted to test the effects of resident physicians working 28-hour shifts, rather than the current 16-hour limit that was imposed in 2011. The Accreditation Council for Graduate Medical Education (ACGME) granted waivers of the duty-hour requirements for 58 general surgery resident programs that participated in the study. The researchers found that patients in this study group did not die or experience adverse events any more than patients in 59 surgery resident programs that stuck to the 16-hour shift requirements.

However, in an editorial accompanying the trial results in the New England Journal of Medicine, John D. Birkmeyer, MD, reached a different conclusion: He found the trial results to be evidence that the shorter duty-hour requirements also do not cause patient harm – a concern among many hospital physicians who worried about patient safety in the face of increased handoffs.

“The FIRST Trial effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care,” he wrote. “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 FIRST trial and a similar ongoing internal medicine study, the Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, both faced heavy backlash from watchdog group Public Citizen and the American Medical Student Association (AMSA). Both groups accused researchers of conducting unethical trials, stating that patients were put at risk of serious complications or death by having overtired resident physicians treat them. They also claimed patients were not told of the trials and, therefore, did not give informed consent. The IRB at Northwestern University in Chicago – the lead institution and IRB of record for the FIRST trial – determined that the trial was not human subjects research and waived informed consent requirements.

Both groups called on ACGME to rescind the duty-hour waivers “The ACGME does not consider either the FIRST or the iCOMPARE trials to be unethical, and has no plans to rescind the waivers,” ACGME CEO Thomas J. Nasca, MD, told IRB Advisor in the January 2016 issue. “Both study protocols were reviewed and approved by the applicable institutional review boards, and the iCOMPARE trial was reviewed and funded by the National Institutes of Health [NIH].”

Following the publishing of the FIRST trial results by the NEJM, Michael Carome, MD, director of Public Citizen’s Health Research Group, released a statement calling the researchers’ results “self-serving” and accusing the NEJM of violating its own publishing policies regarding human subjects research. The statement also goes on to say that FIRST researchers did not collect any meaningful, objective data regarding resident physician health, education, and training outcomes.

Look for more follow-up coverage in the April issue of IRB Advisor.