Sunday, December 6, 2015

Yet another unethical study at the University of Minnesota?

In the BMJ, Jeanne Lenzer writes about two controversial studies on whether exposing medical residents to sleep deprivation has an effect on patient safety.  One of the studies -- the FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees) trial -- was conducted on first-year surgical residents at the University of Minnesota, as well as a number of other sites. The BMJ article is behind a paywall, but I am posting it here in its entirety.

Revelations that two studies waived limits on first year resident doctors’ working hours to investigate whether their patients were more likely to die have led to a public outcry. Public Citizen, a watchdog organization that is based in Washington, DC, and the American Medical Student Association are calling for an investigation into the studies.

Both trials waived the limits on residents’ working hours, which were reduced in 2011 from a maximum of 30 consecutive hours to 16 hours by the Accreditation Council for Graduate Medical Education. The council put the working hour restrictions in place after a 200 report by the Institute of Medicine concluded that first year residents made “more errors when working longer consecutive hours.”2 The institute’s report added, “Entrusting care to residents with inadequate experience is neither good education, nor quality, safe patient care.”

One of the trials, the FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees) trial, involving first year surgery residents, was recently completed, and the iCompare trial, supported by funding from the National Institutes of Health, is scheduled to be completed in June 2016. The primary outcome of both trials is patient deaths within 30 days.

Public Citizen and the American Medical Student Association have asked the Office of Human Research Protection for an investigation into the studies and for an immediate halt to the iCompare study.

Michael Carome, director of Public Citizen’s health research group, told The BMJ that the studies were “highly unethical,” given that harms from sleep deprivation were already known. He cited research showing that sleep deprived resident doctors were more likely to be involved in motor vehicle crashes, to have percutaneous injuries, and to develop severe depression. The two organizations say that degradation in physicians’ performance could cause medical errors “sometimes leading to patient injuries and death.”3

Several studies have underscored the concern about harms to patients. A study of 2737 first year residents found that doctors who worked extended shifts “reported 300% more fatigue-related preventable adverse events resulting in a fatality.”4

The new studies’ waiver on working hour restrictions extends for at least one year after completion of the studies.

Carome also said that the studies violated research ethics because the patients were not told that they were in a study and therefore could not consent to participation. A 2010 survey showed that a majority (81%) of members of the public said that they should be informed if their resident doctor has been working for more than 24 hours, and 80% said that they would want to request a different doctor.5

Carome raised another concern about the study design of the FIRST trial, because it was a “non-inferiority trial that plucked an arbitrary margin of a 1.25% absolute risk and 12.5% relative risk.” He said, “That could mean more patients die, but it would be called statistically insignificant.”

Thomas Nasca, chief executive officer of the Accreditation Council for Graduate Medical Education, defended the need to conduct multicenter controlled studies. He told The BMJ that since 2011 several studies have criticized the 16 hour working hour limitation as “disruptive to resident education and to patient care and safety due to increased transitions in care [from one doctor to the next].”6

Nasca acknowledged studies showing potential deterioration in resident skills because of sleep deprivation but said that harm to patients was prevented, because first year residents “don’t operate on their own [and] they are under 24 a day, seven days a week supervision consistent with the 2008 Institute of Medicine recommendations to provide onsite supervision as essential to the protection of patient safety.”

Nasca said, “The investigators and institutions, their institutional review boards, and NIH [National Institutes of Health] are very scrupulous in protecting the interests of patients.”

Deborah Vozzella Hall, national president of the American Medical Student Association, told The BMJ, “People talk about the risks of increased hand-offs, and there is a risk of error with more handoffs. That is known and can be improved. But once you come up against the limits of neurobiology there’s nothing you can do. Nothing will mitigate that risk.”

Charles Czeisler, professor of medicine and director of the division of sleep medicine at Harvard Medical School, told The BMJ, “I was shocked when I heard about this study assigning resident physicians to work marathon shifts.” Czeisler said that even as little as one week of sleep deprivation was known to cause serious health harms.

A spokesperson for the US Department of Health and Human Services told The BMJ that the agency was “reviewing the allegations.”

The studies involve tens of thousands of patients in 159 hospitals in the FIRST trial and in 63 hospitals in the iCompare trial. People concerned about whether they were experimental test participants can see the lists of participating hospitals and training programs at and

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