According to a survey of the general public by Public Citizen, 86% of respondents were against eliminating the 16-hour shift limit for interns set by the Accreditation Council for Graduate Medical Education. From MedPage Today.
This article first appeared September 13, 2016 on MedPage Today
By Shannon Firth
WASHINGTON -- Nine in 10 respondents to a national survey said they opposed scrapping a rule that limits the number of continuous hours first-year medical residents can work.
According to the survey of the general public by Public Citizen, 86% of respondents were against eliminating the 16-hour shift limit for interns set by the Accreditation Council for Graduate Medical Education's (ACGME), while 80% also supported dropping the maximum shift limit for second-year residents and above from 28 hours to 16 hours.
"Our basic take-home message today is that now is not the time for the ACGME to backtrack and allow resident physicians to work longer hours,"said Michael Carome, MD, director of the health research group for Public Citizen, which released the poll results during a press briefing on Tuesday.
Public Citizen engaged Lake Research Partners, an independent polling company, with conducting the survey about the public's attitude towards current restrictions on residents' work hours in response to mounting pressure on ACGME from physician organizations to soften such restrictions, and allow residents to work 28 hours or more without sleep.
Approximately 500 individuals participated in the 10-minute phone survey, which was "stratified geographically to reflect the expected voter turnout of the 2016 general election," and whose demographics were designed to mirror that of the U.S. adult population, according to the report.
In addition to the findings around work-hour policy, Public Citizen noted that 77% of respondents said they believe patients should be told if the medical resident treating them has worked more than 16 hours without rest.
The Public Citizen report also highlighted the following adverse impacts of sleep deprivation on medical residents and their patients:
- A 2005 study found interns doubled their risk of motor vehicle accidents and were at six times the risk of "near miss driving events" after shifts of 24 hours or longer
- A 2006 prospective cohort study of self-reported percutaneous injuries among interns that found "lapses in concentration" and "fatigue" were more likely to occur on extended shifts and were primary contributors to such injuries
- A 1993 study reported internal medicine residents working 32-hour shifts every fourth night demonstrated "significantly higher rates of depression symptoms"
- A 2004 study found interns working 24 hours or more made 36% more serious medical errors.
The ACGME is in the process of doing its own data review. In September 2015, it created a task force to review current resident duty-hour restrictions and produce a report, slated for release in the coming months. To date, the task force has reviewed the scientific literature -- over 120 position papers and responses -- and heard testimony from over 40 organizations including residents, according to Thomas Nasca, MD, ACGME CEO.
The task force will collect feedback on any proposed modifications during a 45-day public comment period, and the implementation of any revised requirements will target the 2017-2018 academic year.
Background
In 2003, the ACGME instituted standards for resident hours that included an 80-hour weekly limit, averaged over 4 weeks, and a 24-hour limit on continuous duty.
Roughly 5 years later, the Institutes of Medicine issued a report cataloguing the risks incurred by residents, and by patients, when residents worked for extended shifts, and recommended that no resident be allowed work for more than 16 hours at a time without sleep.
In 2011, the ACGME responded to this guidance by tightening its duty hour rules for interns to no more than 16 hours.
However, in the last few years, the council has issued waivers to medical institutions involved in two broad cluster-randomized trials that aim to study the impact of residents' shift length on patient safety and cost, and medical education: the Flexibility In Duty Hour Requirements for Surgical Trainees Trial (FIRST), and the ongoing Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
The FIRST trial, a prospective cluster-randomized noninferiority study was completed in June 2015 and the results, published 2016, showed that flexible, less-restrictive duty-hour policies for surgical residents were associated with noninferior patient outcomes and no significant difference in residents' satisfaction with overall well-being and education quality," according to the study authors.
The ACGME granted waivers in the two trials in order to evaluate the impact of the 2011 duty-hour requirements on patient safety and the welfare and education of residents, according to Nasca.
But the council stopped short of waiving the 2003 duty-hour requirements for all specialties, and for internal medicine since the early 1990s, specifically working 80 hours per week, averaged over 4 weeks, and having 1 day off every 7. Also, 24-hour in-house call duty cannot occur more frequently than every third night.
In 2015, Public Citizen and the American Medical Student Association demanded that the Office for Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services, investigate the two trials.
While Carome said the OHRP acknowledged receiving Public Citizen's complaint letters, "it appears that they've taken no action."
One of Public Citizen's core criticisms of both trials is that neither patients nor residents were given informed consent before participating. Their current survey found that 86% of respondents would want to know if they had been admitted to a hospital in the experimental arm of such trials.
"There are probably tens of thousands of patients who have unwittingly participated in these two trials over the past 2 years; who have no idea that they were being treated by first-year residents who were allowed to work up to 28 hours or longer without sleep," said Sammy Almashat, MD, MPH, of Public Citizen's Health Research Group.
Moreover, the FIRST trial inadequate design left it "underpowered" to detect certain changes because it did not measure "intern-specific performance measures," according to Charles Czeisler, PhD, MD, of Brigham and Women's Hospital in Boston. He told MedPage Today that the study's main outcomes -- morbidity and mortality -- were unrelated to the performance of interns whose schedules were modified as they are unable to operate at that point in their career.
"And so to subject the interns to this kind of a health risk would be like randomizing people to be in a group that is exposed to smoking or second-hand smoke without their consent to do an evaluation that does not even measure any of the health outcomes. No motor vehicle crash data were collected, no health data, blood pressure, illnesses. Nothing was monitored. No suicides, depression. etc.," Czeisler, who was not involved in FIRST or in the current survey, told MedPage Today.
No Complaints
"We had something on the order of a 99% response rate for 4,000 some residents, and were able to examine a lot of characteristics about their well-being about their views on patient safety; about their views around needle sticks and car accidents," countered Karl Bilimoria, MD, principal investigator of the FIRST trial, to MedPage Today.
Much of those findings were included in the initial report and additional data will be released in other papers within the next few months, added Bilimoria, who is at Northwestern University in Chicago.
"Between all the hospitals and program directors, we probably had 500 or 700 people who actually had to sign off on the study conduct. Not only that, but there were multiple institutional review boards that looked at this," he said.
Bilimoria stressed that no residents or oversight organizations have filed complaints with the FIRST trialists. "Really the only group that's really complained about this is Public Citizen."
Bilimoria also argued that the reports cited by Public Citizen in defense of restricting duty hours due to motor vehicle accidents, accidental exposures and depression, involved studies from individual institutions or anecdotal evidence. While additional findings from FIRST are currently under embargo, "[Public Citizen's] concerns will not be supported by the data."