By: Alison Case, MD, AMSA Education and Advocacy Fellow
Within the last week, a number of news outlets reported the results of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial, carried out in more than one hundred general surgery training programs across the U.S. Headlines such as, “Longer Surgical Resident Shifts Pose No Risk to Patients” and “Study on Risks of Medical Resident Work Hours Yields Surprising Results” seem to reassure readers that physicians-in-training are capable of working more than 28 consecutive hours without increasing the possibility of patient harm.
Yet most of these stories also include important rebuttals from experienced physicians in academic institutions questioning not only the results of the trial, but its very construct.
Last fall, AMSA joined Public Citizen in publicly opposing the trials due to their design and unethical assumptions. Both organizations called on the Office for Human Research Protections to launch an official investigation into the trials as well as on the ACGME to immediately rescind the duty hour waivers that had been given to participating programs. “The results were expected, because the research was designed in a biased manner,” said Michael Carome, Director of Public Citizen.
Below are the facts medical students need to know:
- Work hours were not changed for all clinicians. Only first year residents – a small percentage of those caring for patients at participating institutions – were subject to different hours. This arrangement significantly decreased the opportunity to observe disparities in outcomes.
- The only way residents could have opted out of participating in the trial would have been to abandon their training programs. Such a protocol is a violation of standard ethical research practices; it is tantamount to coercion, given the difficulty a resident would face if they attempted to leave their institution and find placement in another.
- The trial was identified and approved by its IRB as not involving human subjects despite federal regulations and ethical standards which state that studies collecting data as a result of human interactions qualify as human subject research.
The results of the study, as reported, belie a natural assumption: that tired residents endanger patients. What the studies did not address was the potential for residents to first harm themselves, and in turn, harm patients. An exhausted resident is more likely to experience needle sticks, become involved in motor vehicle accidents, and suffer from depression. Absent from the study protocol, as well as the discussions with investigators, was acknowledgment of these very real and well-documented risks. The occurrence of such incidents was not monitored, and given the absence of an informed consent process, the resident participants were not informed of such risks. While interns did complete a survey approximately halfway through the study, no standardized tools were identified or used to measure deterioration or changes over time.
So, what does this mean for medical students? Simply put, your future in residency may be different than what you had in mind. Trials raising real ethical concerns, like the FIRST trial and iCompare, an ongoing trial similar to FIRST involving more than sixty internal medicine training institutions, may dictate future resident duty hour requirements. In this case, what you don’t know really could hurt you.
All residents are expected to maintain accountability for their fitness for duty and capacity for empathic, patient-centered care. To adequately prepare themselves for the next step in their education, medical students should stay informed and understand all sides of the ongoing duty hours debate—including an understanding of the limitations and ethical considerations of the FIRST trial and others like it.
For more information, please visit https://www.citizen.org/icompare.