Two organizations are demanding an investigation into what they say are unethical clinical trials that have required first-year medical residents around the country to work up to 28 hours or more at a time.
In letters sent to the Office for Human Research Protections at the department of Health and Human Services and the Accreditation Council for Graduate Medical Education (ACGME), the American Medical Students Association (AMSA) and the watchdog group Public Citizen claim the exposed both the medical trainees and patients to a wide range of risks, including exposure to blood-borne pathogens.
The letters demand an immediate halt to iCOMPARE, which is an ongoing study, as well as an investigation of that trial and the FIRST study, which was completed in June 2015. They also want sanctions implemented against all the institutions that took part in the trials.
"The 2011 work-hour restrictions were put in place because of clear evidence of risk to resident physicians," Deborah Hall, MD, a physician and national president of the medical student association, said in a statement.
The groups cited a 2010 survey of the general public in which 81% said that patients should be informed if a treating resident was working more than 24 hours and, if so, 80% would want a different doctor.
"Few patients would voluntarily agree to be enrolled in such trials if given the opportunity to choose," said , director of public citizen's Health Research Group.
, and CEO of the ACGME, said other safeguards have remained in place for the trials. They include a maximum work week of 80 hours, a mandatory one day off every seven days, and no more than one night shift every 3 days.
He said institutional review boards at all the participating hospitals reviewed the trial protocols and determined that patients did not need to be informed.
Nasca noted that since 2003 second and third year residents have been working up to 28-hour shifts. Prior to that, they worked shifts of up to 36 hours.
New residency work hours adopted by the ACGME limit shifts to 16 hours, but critics of those reduced hours said shorter work shifts diluted the training experience, a hallmark of which was long hours with little sleep and high demands. They also pointed out that shorter shifts mean more frequent patient "hand-offs," a known risk to patient safety.
In the letters, AMSA and Public Citizen note that primary goal of the two trials -- one of which is ongoing -- is to determine whether the rates of death and serious complications for patients "unwittingly enrolled in the trials" are higher at hospitals where residents are required to work shifts for as long as 28 hours than the rates at hospitals that follow the current 16-hour work shift standard.
Asked about the claims made by AMSA and Public Citizen, , director of the internal medicine residency program at Medical College of Wisconsin said, "The issues they raise aren't anything we didn't think about a lot."
However, he said there have not been good data to show which risk is greater: longer work shifts or handing off patients to a new shift of doctors who are unfamiliar with their cases.
Frank said that hospitals wanted to know if longer shifts that would help prevent handoffs to unfamiliar doctors would improve patient outcomes.
At the Medical College, administrators have issued their own safeguard: a cap on the patient workload for residents. Frank said that for each resident team there was a limit on how many patients they can be responsible for. Those caps are adjusted for the kinds of patients being seen and how sick they are as well as the number of residents on the teams that care for them.
"This is done to make sure the patients are safely cared for and that the residents don't get overworked while doing so," he said.
Frank acknowledged that patients at Froedtert Hospital, which is one of the hospitals participating in the iCOMPARE study, were not informed about the trial.
In total, the trial involves 37 first-year internal medicine residents plus others from different specialties who may temporarily rotate into the program.
The University of Wisconsin Hospital and Clinics took part in a limited way in the FIRST study, which ended in June.
In a statement, UW spokesperson Lisa Brunette, said first-year residents were allow to work up to 18 hours, not the 28 cited by the organizations.
She said evidence about longer work hours is incomplete and often contradictory.
"Recent studies, including several in Europe, have yielded worrisome trends, including residents who report feeling less prepared to go into private practice, who do less follow-up on their patients, and have many more 'hand-offs' or transitions between caregivers – the latter being a known risk factor for medical error," she said.