Two Trials Extending Resident Hours Called 'Unethical'

November 23, 2015

Two trials extending shifts of first-year residents from 16 hours to as many as 28 or more at nearly 190 teaching hospitals to see what would happen to patients and trainees alike have come under fire as "unethical."

Leveling that charge is the consumer watchdog group Public Citizen and the American Medical Student Association (AMSA), which includes residents. The two groups say that the trials not only have exposed sleep-deprived residents and their patients to harm but also have failed to obtain informed consent from them.

"These are among the most unethical studies I've seen in the past couple of decades," said Michael Carome, MD, director of Public Citizen's Health Research Group, in an interview with Medscape Medical News.

On November 19, Public Citizen and the AMSA asked the Accreditation Council for Graduate Medical Education (ACGME) in a joint letter to rescind waivers on current limits to first-year resident hours that the group issued to make the trials possible. They also have demanded that the Department of Health and Human Services investigate.

The objections come in the wake of studies reporting that shortened resident hours introduced by the ACGME in 2003 and 2011 have not improved patient outcomes. And ACGME CEO Thomas Nasca, MD, notes that for the sake of fine-tuning training policies, only the Institute of Medicine (IOM), in 2009, recommended large-scale, specialty-specific studies on how resident hours affect patient safety — the sort of studies now being criticized by Public Citizen and AMSA.

"We received the letter this morning [November 19], and we were a little bit surprised," Dr Nasca told Medscape Medical News.

"Strategic Napping...Is Strongly Suggested"

In 2003, the ACGME limited the work weeks of all residents to 80 hours, averaged over 4 weeks, and on-site duty, including in-house call, to shifts of no more than 30 hours. These 30 hours consisted of a maximum 24 straight hours of duty and up to 6 additional hours, designed to give residents time for patient handoffs, outpatient clinics, and didactic activities, among other things.

In 2011, the ACGME restricted first-year residents to shifts of 16 hours, and other residents to 24 hours. For the latter group, "strategic napping...is strongly suggested," especially after 16 hours of continuous duty and between 10 pm and 8 am. Residents beyond their first year also can be asked to stay after their shift if need be, but not beyond 4 hours.

The two trials in question evaluate whether ACGME restrictions need to be revised.

One study ended this spring, but its ACGME waivers on first-year residency hours remain in effect until the spring of 2016, when data collection wraps up. This study, called Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST), is sponsored by Northwestern University, in Evanston, Illinois. Collaborators are the ACGME, the American College of Surgeons, and the American Board of Surgery. The roughly 160 participating hospitals include Brigham and Women's Hospital, in Boston, Massachusetts; Johns Hopkins Hospital, in Baltimore, Maryland; the Mayo Clinic Hospital (both campuses), in Rochester, Minnesota; the University of California, San Francisco, Medical Center; and Vanderbilt University Hospital, in Nashville, Tennessee.

For the 2014-2015 academic year, general surgery residency programs at these hospitals were randomly assigned to either a control arm that adhered to current ACGME work policies or an intervention arm that was granted duty-hour flexibility. The latter group could ignore all ACGME rules except for three. Residents still could not work more than 80 hours a week on average nor take in-house calls more frequently than every third night, and they had to have at least 1 free day per week on average.

FIRST guidance to participating hospitals posted on the study's website suggested that first-year residents take 24-hour call instead of shorter shifts to improve continuity of care — a priority for critics of ACGME policies. Furthermore, residents should be encouraged to stay at the hospital when needed after their shift and beyond the current 4-hour limit set for more senior trainees. All residents may be scheduled to rounds following 24-hour call as well. However, FIRST preserved the ACGME recommendation for "strategic napping" after 16 continuous hours.

The primary outcome measure for patients treated by the two different sets of residency programs was death within 30 days, according to the website ClinicalTrials.gov. Serious morbidity within that time frame was a secondary outcome. In addition, residents completed surveys about duty hour policies and procedures.

Trial organizers hope to publish their results next spring. "We would hope that this would result in an ACGME policy change in time for the 2016-2017 academic year," they stated in an online FAQ document.

The other trial, still in progress, goes by the mouthful, Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE). Aimed at internal medicine residents, iCOMPARE is sponsored by Johns Hopkins University, funded by the National Institutes of Health, and supported by the ACGME. The University of Pennsylvania, home to principal investigator David Asch, MD, and Harvard Medical School are collaborators.

Many of its 63 hospitals also participated in FIRST. iCOMPARE assigns internal residency programs in its hospitals to one of two arms along the same lines set forth in its general surgery counterpart. Investigators will look at 30-day patient mortality as the primary outcome and survey residents on their training and average amount of daily sleep. The study is expected to end in June 2019.

Is Continuity of Care a Trump Card?

Dr Carome said not all residency training programs in intervention arms of the two studies have required first-year residents to work 28 hours shifts as the protocols allow, but some have. Some residents even report 30-hour shifts. "And sleep is not guaranteed," he said.

Public Citizen and the AMSA question why the ACGME would permit these longer shifts after curtailing them in 2011 in light of their documented detrimental effects. For residents, they include a higher rate of needle sticks, depression, and motor vehicle accidents on the way home from work. As for patients, the two groups quote the ACGME in 2011 as saying, "PGY-1 residents make more errors when working longer consecutive hours."

In response, the ACGME's Dr Nasca calls resident scheduling rules a work in progress, especially because only very small, single-institution studies have examined the effect of long hours on residents and patients. "So these groups of investigators put together multi-institution, randomized clinical trials to look at these issues," Dr Nasca said.

First-year residents in the ongoing iCOMPARE study still cannot work more than 80 hours a week on average, and they remain under continuous on-site supervision and operate in teams, he said. "All these structures were retained for patient safety," he said.

The ultimate goal, he said, is partitioning the 80-hour week on a specialty-by-specialty basis "to reduce the transitions of care as much as we can."

Karl Bilimoria, MD, the principal investigator for FIRST, agrees.

"There's a balance," said Dr Bilimoria, a professor of surgery at Northwestern University. "Sleepy residents may commit errors, but breaks in continuity of care can make for worse patient care."

Dr Carome at Public Citizen counters that there are other ways to promote continuity of care besides longer shifts.

"Maybe you need more staff, with more overlapping schedule," Dr Carome said. "The answer is to spend more money and look for better ways to implement the ACGME restrictions without going backward."

Residents Complain They Were Kept in the Dark

The other sore point in the controversy is lack of informed consent, which is closely tied to decisions by the institutional review boards (IRBs) of participating hospitals. In the case of iCOMPARE, the IRB of the University of Pennsylvania agreed to be the IRB of record, meaning that hospitals could default to its determinations instead of having their own IRBs sign off on the study.

As reported last month by the Washington Post, the IRB of the University of Pennsylvania classified FIRST as a "minimal risk" study, a designation "critical to the decision to waive the usual requirement to inform patients and doctors they would be participating in an experiment." The newspaper quoted a university official as saying that it would be impractical to obtain informed consent from "every internal medicine patient at all of the participating hospitals."

The website for iCOMPARE sets forth a version of informed consent for residents. Internal medicine residency programs "will inform their applicants" of their participation in iCOMPARE. By completing study surveys later on, trainees will provide their consent.

However, that protocol apparently has not always been followed, according to the Washington Post. It quoted two first-year residents in psychiatry at the University of Washington School of Medicine as saying that nobody told them they might pull 30-hour shifts when they applied. The university said it notified internal medicine residents about the trial, but not psychiatry residents, who study internal medicine in their first year, according to the Washington Post.

Medscape Medical News requested an interview with Dr Asch, the study's principal investigator, but instead received a written statement from Susan Phillips, senior vice president for public affairs at the University of Pennsylvania Health System.

"As medical providers," said Phillips, "patient safety is always our top priority, and as educators, we seek to offer the very best training to young physicians as they learn to care for patients outside of a supervised environment.

"The study was designed and vetted by regulatory bodies, research review boards and established ethics panels. Importantly, at the study sites there are no changes to the existing and exhaustive supervision requirements for physicians in training."

FIRST Deemed Not to Be "Human Subjects Research"

The informed consent issues for FIRST roughly follow along the same lines. The FIRST website explains that the IRB at Northwestern University deemed it "exempt" research because, among other reasons, "the intervention is at the hospital level (no patients to consent)." Accordingly, FIRST did not need approval from the IRBs at participating hospitals, "but we leave that up to each individual site." FIRST also said the Northwestern IRB did not consider the study to be "human subjects research."

Public Citizen and the AMSA bristle at the notion of patients not learning that a yawning first-year resident at their bedside was on the tail end of a 28-hour shift. They cite a survey published in BMC Medicine 5 years ago showing that 8 of 10 Americans want to know whether their physician has been working for more than 24 hours, in which case the same percentage would choose another physician.

Northwestern's Dr Bilimoria told Medscape Medical News that it was up to each hospital in FIRST to decide whether it would obtain informed consent from patients and that he does not know what action they took. Like Phillips at the University of Pennsylvania, he raised the issue of whether it is feasible to get informed consent from tens of thousands of hospital patients in such a study.

Dr Bilimoria said that for first-year general surgery residents assigned extended hours at intervention-arm hospitals, the trial was no secret. "They were told, because they had to monitor their hours," he said. "Residents knew which arm of the trial they were in.

"This has been very public."

Asked whether this process amounted to informed consent, he replied that if residents strongly disagreed with the prospect of longer hours, "they could choose to work elsewhere."

Dr Bilimoria said he has not heard of any complaints from residents in FIRST about extended shifts. Instead, "the enthusiasm among residents and faculty has been high," because duty-hour flexibility improves patient care, particularly by reducing patient handoffs.

"Nobody wants a doctor to leave a patient who's still stabilizing in the ICU or while an operation is in progress," he said. Besides being good for the patient, flexible schedules are good for the residents' education. "You allow the resident to see patients throughout all the critical portions of their care."

He reiterated the argument made by the ACGME's Dr Nasca that both FIRST and iCOMPARE represent the kind of multisite studies proposed by the IOM to determine the exact effects of resident hours on patient outcomes.

"We're essentially following their recommendations," he said.

For his part, Dr Carome at Public Citizen questions any study, whether or not it has the imprimatur of the IOM, that calls for exposing participants to known harm. "It's fundamentally unethical," he said.

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