While there are passionate opinions on how many hours medical residents should work per shift, there is very little data to suggest that slashing their schedules is ultimately safest for the patient, researchers say.
The shorter hours could also result in unintended consequences, argue supporters of two studies that were called “highly unethical” by advocacy groups.
The studies, which evaluate the impact of resident work hours on patient safety, randomly assigned first-year medical interns to work shifts that could be longer than the maximum 16 hours currently recommended.
“The key piece is that we just have never had prospective, randomized high-level evidence to inform our decisionmaking,” said Dr. Karl Bilimoria, vice chair for quality in the surgery department at Northwestern University's Feinberg School of Medicine. “That's why these trials are so important.”
Criticism was anticipated, so that's why the review processes was thorough, Bilimoria said. Still, ethicists not involved in the research continue to question how the study could have been approved, given that the primary outcomes measured are patient injury and death. The studies have also been criticized for lacking patient informed consent.
The Flexibility In Duty Hour Requirements for Surgical Trainees Trial study went through institutional review and was evaluated by bioethicists and committees at each of the 152 participating sites.
The other study—Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education—is led by researchers from the University of Pennsylvania. The academic medical center said that study design was also vetted by regulatory bodies, review boards and ethics panels.
Other ethics researchers found it difficult to understand how such a trial could be approved by an institutional review board.
“Because you're looking at deaths of patients as the major outcome, that makes it much more difficult ethically to support because patients may be harmed,” said Dr. Robert Klitzman, director of the master of bioethics program at Columbia University. “If you find that twice as many patients died under anything but the current system, you could say they died unnecessarily.”
Klitzman authored a new book that suggests institutional review boards are structured in a way that could be harmful.
The institutions involved in the studies say the goal is to better inform policy.
“There is considerable concern among experts in the field that the current duty hour system of residency education may limit the nation's ability to train physicians effectively,” said Susan Phillips, senior vice president for public affairs at Penn Medicine in an e-mailed statement.
In a tweet Thursday, Dr. Mark Friedberg, a senior natural scientist for the RAND Corp., whose work focuses on quality measurement and performance improvement, said he was surprised by the hot takes on the very complex issue.
He said what most surprised him is the assumption that the effects on adjusted work hours are already known. While it's certainly better to have clinicians that are not overly fatigued, it's also important that sudden changes not disrupt an already complicated healthcare system.
“There's always a trade-off,” Friedberg said, noting the increased number of patient hand-offs that occur with shorter hours. These hand-offs reduce consistency of care and open patients up to more mistakes and miscommunication among providers. “It's not clear-cut. That's why you have to do the science,” he said.
Work-hour restrictions have been hotly debated among those wanting to restructure postgraduate medical education. Medical residents had previously been allowed to work shifts of up to 30 consecutive hours. In 2011, the Accreditation Council for Graduate Medical Education updated its standards, limiting first-year residents to 16-hour shifts and other residents to 24-hour shifts.
According to Bilimoria, the ACGME signed off on his trial. He says the participation of residency programs from across the country demonstrates support and demand for the data.
Still, Klitzman contends that the trade-offs are too great. He said he would have suggested looking retrospectively at the number of patients who died or were injured under the old system, then tracking how many of those incidents happen under the new system. “There's other sources of data they could have used to answer the question,” he said.
