Current rules that restrict residents' hours could cause more harm than good, concludes a new study published Tuesday in the New England Journal of Medicine.
The study is one of two controversial clinical trials focused on work hours for medical students that critics describe as riddled with conflicts and dangerous for patients and practitioners.
The Flexibility in Duty Hour Requirements for Surgical Trainees Trial, known as FIRST, was led by Dr. Karl Bilimoria, director of the surgical outcomes and quality improvement center at Northwestern University's Feinberg School of Medicine.
The risk of death and serious complication was not greater among patients cared for by surgeons who worked longer than recommended shifts, concluded the study.
“It may be counterintuitive, but flexibility appears to be safer for patients,” he argues, despite criticism of the study's methodology.
In fact, continuity of care, which could lead to fewer mistakes, was more consistent during those longer shifts.
Medical residents had previously been allowed to work shifts of up to 30 consecutive hours, but some argued that sleep-deprived clinicians threaten patient safety.
In 2011, the Accreditation Council for Graduate Medical Education updated its standards, limiting first-year residents to work no more than 16-hour shifts or 80-hour workweeks, and other residents to 24-hour shifts.
The FIRST study aimed to compare the current standards with more flexible hours. Doctors participating in the study had to adhere to the ACGME duty hour requirements, but those working the flexible hour schedules were granted a waiver by the group to work longer shifts and have less time off between shifts when they felt it was necessary.
The ACGME, along with the American College of Surgeons and the American Board of Surgery funded the trial, and that is just one of the aspects being criticized.
“This is very much agenda-driven research,” argued Dr. Michael Carome, director of Public Citizen's Health Research Group. “They never liked the restrictions in hours.”
In November, Public Citizen wrote to HHS' Office of Human Research Protection, calling FIRST and another similar trial, the Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education, known as iCOMPARE, "highly unethical."
The group took issue with "the failure of the researchers to characterize (these trials) as involving human subjects, nor get informed consent of the trial subjects."
Those "all represent egregious ethical lapses,” especially because the studies looked at potential deaths, Carome argued.
He said the study's findings should never be published given these oversights, and that the Office of Human Research Protection should hasten its review of the clinical trial approval process. The office said in an e-mail it is still reviewing the allegations.
“Anything that involves putting patients at serious risk, especially by going against recommendations … demands more consent from patients,” Art Caplan, a medical ethicist at New York University's Langone Medical Center, told Modern Healthcare last year about the trials.
But Dr. Peter Angelos, associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago, said the trials were necessary.
Recent shift restrictions were established with only “conventional wisdom” that suggests residents work better when they sleep longer, he said. “There was no prior assessment of what would be the impact on millions of patients in the U.S. That's something that would never happen with a new drug.”
Further, Angelos added, multiple studies now suggest the shift restrictions impair physicians' training and there is little to no data to show an improvement on patient outcomes.
However, Carome points to a 2008 report on resident duty hours from the Institute of Medicine. That analysis of existing data found that clinician sleep deprivation contributes to increased errors and accidents.
Another NEJM publication by Harvard researchers in 2004 found interns made 36% more serious medical errors, such as medication and diagnostic mistakes, during the traditional, longer schedules than when they worked shorter shifts.
Data in the FIRST trial included patient outcomes data drawn from 138,691 patients undergoing surgery by residents in 115 general surgery programs at 148 affiliated hospitals from July 1, 2014, to June 30, 2015.
The institutional review boards at each of those institutions approved the design, Bilimoria said. And they all wanted to ask a fundamental question: “Is there a risk to the patient?” he said. “There may actually be risk to the patient in not doing the study.”
Residents were also surveyed about the overall quality of the education they were receiving and their own well-being. While 13% of residents on the standard shift reported that they had to leave during an operation, only 7% working the flexible hours reported having to do so. Likewise, of those working the standard hours, 42% and 46% said they had to miss an operation or hand off the patient to someone else, compared to 29% and 32% of those working more flexible schedules.
Critics point out that the trial did not systematically collect data on residents' health outcomes, such as the increased risk of motor vehicle accidents and needle-stick and other injuries that were identified in previous trials.
The study authors, who presented the findings Tuesday during the Academic Surgical Congress in Jacksonville, Fla., also note that this study focused on surgery and may not be generalized to nonsurgical specialties. The authors say there may be reasonable need for specialty-specific duty hours.
The iCompare trial, for which the research is ongoing, is looking at the outcomes on duty-hour changes for internal medicine.
The concerns about the studies' design raised questions about the process of getting approval from institutional review boards to conduct a trial. The boards, which are designed to protect patients from unethical human research practices, are under new scrutiny from critics who say troubled trials are approved because the boards are too lax, have unqualified members, are riddled with institutional and personal conflicts and are overwhelmed by the volume of studies they must review.