Just a few years after the medical community established limitations on the work hours of new interns, the time limits are being re-evaluated for their impact on patient care and doctor training — a move that has sparked debate among consumer advocates and the medical community.
Dozens of hospitals around the country, including some in Baltimore, are participating in a pair of studies to assess whether allowing medical residents to work longer hours for needed on-the-job training benefits or harms patients.
The maximum number of work hours for first-year residents was nearly halved from 30 consecutive hours to no more than 16 hours after a 2009 report from the Institute of Medicine raised concerns about the sometimes-deadly effect of exhaustion on decision-making.
That report also called for further evaluation of the issue, which is what hospitals say the current studies are doing. But the re-examination has spurred health care watchdogs to ask federal officials to intervene.
"These are the least-trained and -experienced among physicians, often known as interns," said Dr. Michael Carome, director of Public Citizen's Health Research Group, which wrote letters to federal officials along with the American Medical Student Association, which also opposes relaxing work-hour limitations for the purposes of the studies. "Limits were put in place for a reason."
Multi-year residencies, essentially continuing education in real-life settings under the supervision of other doctors, are generally required for doctors to practice medicine in the United States. The Accreditation Council for Graduate Medical Education sets rules such as the restrictions on work shifts imposed in 2011.
A series of studies found that doctors-in-training make 36 percent more medical errors when they worked more than 24 hours than those who worked 16 hours, and make 300 percent more fatigue-related medical errors that lead to patient deaths, doctors from the Harvard Work Hours Health and Safety Group wrote in a 2007 article for the Joint Commission Journal on Quality and Patient Safety.
But some medical educators say research has since shown that there have been unintended consequences of limiting hours, including errors linked to handing off patients from one doctor to another and gaps in learning by doctors who can't follow cases through.
The accreditation panel allowed longer shifts for the studies so hospitals could determine if the current system is "achieving the highest possible standards with respect to patient and resident/fellow safety, and physician education," said Dr. Thomas J. Nasca, CEO of the accreditation council.
The studies represent the "gold standard" for evaluating patient outcomes, he said.
One study recently ended among general surgery residents at 159 hospitals, including Johns Hopkins Hospital, the University of Maryland Medical Center and Sinai Hospital in Baltimore. Another study among internal medicine residents continues at 63 institutions, including Hopkins, Maryland and Hopkins Bayview Medical Center in Baltimore and Greater Baltimore Medical Center in Towson.
The watchdog groups called the studies unethical, saying they put residents and patients at risk and did not seek the consent of patients before including them in the studies. Consent also was not sought from all residents involved in the studies.
Officials with the U.S. Department of Health and Human Service's Office for Human Research said they are reviewing the allegations. The hospitals and the accreditation council defended their participation in the new studies, which have funding from the National Institutes of Health.
"The goal is to determine the ideal balance of work hours for physicians in training to ensure the best possible outcomes for our patients in conjunction with the well-being of the physicians in training themselves," said Kim Hoppe, spokeswoman for the Johns Hopkins medical system.
As part of the ongoing study, called iCompare, participating hospitals will follow residents working 16- or 28-hour shifts and measure impacts to patients' 30-day mortality, length of stay and 30-day readmission rates. Intern education, including standardized test scores, will be evaluated along with their well-being and safety, length of sleep and alertness, Dr. Sanjay V. Desai, one of the lead investigators of iCompare and director of the internal medicine residency program at Johns Hopkins Hospital, said in a 2014 news release before the study began.
"Our hope is this will inform medical education policy," Desai, who is also an associate professor of medicine at the Johns Hopkins School of Medicine, said in the statement. "If we determine that patients are safe during a longer work shift, sleep is better for interns and education is improved, then the current policy could be made more flexible."
Hopkins officials did not make Desai available for an interview despite repeated requests.
The debate about work hours is not lost on medical residents.
David Harari, a first-year resident at University of Washington Medical Center in Seattle, which is taking part in the studies, likened working 30 hours straight to "essentially working while intoxicated."
"It feels awful, really awful," said Harari, who worked five shifts of 30 or more hours in one month. "Your circadian rhythm is out of whack, you feel physically drained and fatigued. I got [gastrointestinal] symptoms. I got a migraine after 24 hours. And we're making life-and-death decisions."
Harari spoke to supervisors and was pleased when they allowed residents who were not training in internal medicine to opt out of the study. He is a psychiatry resident.
Harari emphasized that he was pleased with his education, colleagues and supervisors, but said he's concerned about residents' schedules in general. All residents can work up to 80 hours in a week, and that is not under review by the new studies. Neither is how to safely hand off patients to other doctors, which happens no matter how long a resident works.
What troubles him most about the studies is that patients don't know who is treating them.
"People aren't aware," he said. "That should shock everyone, not just me. Everything we do in medicine has risks, and that requires informed consent. This should be no different."
Recent research found shorter work shifts didn't improve patient safety or increase resident sleep hours. A 2013 study at Hopkins led by Desai and published in JAMA Internal Medicine suggested that limiting shifts also decreased training time and increased risk to patients who were handed off from one doctor to another during shift changes.
Desai and other study authors looked at data leading up to the 2011 reduction in work hours, where residents worked 16-hour shift or shifts up to 30 hours. They found residents didn't sleep more on the shorter shifts but they did hand off patients up to three times more often, potentially leading to more errors. Rounds with senior physicians, an important educational tool, also were cut.
"The consequences of these sweeping regulations are potentially very serious," Desai said in a 2013 statement about the study. "Despite the best of intentions, the reduced work hours are handcuffing training programs, and benefits to patient safety and trainee well-being have not been systematically demonstrated."
Hospitals participating in the studies said the welfare of patients and residents was a top concern.
"Large multi-center trials such as these address key questions concerning the effects of duty hour requirements on patient care and safety, and the development and well-being of the physician," said Karen Lancaster, a spokeswoman for the University of Maryland Medical System.
Continuous supervision of residents remains in place, added Helene King, spokeswoman for Sinai Hospital.
Greater Baltimore Medical Center said its participation was limited to its residents being part of a "control group," meaning the limits on first-year residents were never lifted there.
The University of Pennsylvania hospital took the lead on the ongoing study of internal medicine residents, and a hospital representative said it was designed and vetted by regulatory bodies and the hospital's ethics board.
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The study will provide "much-needed evidence to assist policymakers" on doctor education, which some in the medical community are concerned is now less effective, said Susan Phillips, a spokeswoman for Penn Medicine, the university health system.
But Public Citizen's Carome said there already is research showing residents working long hours are more prone to mistakes. Studies also have shown sleep deprivation increases the risk of car crashes, needle-stick injuries, exposure to blood-borne pathogens and depression in trainees, he said.
Carome said all residents, not just the hundreds of mainly first-year trainees involved in the studies, should be limited in the number of consecutive hours they work. He also believes the tens of thousands of patients likely treated during the studies should have a say since they could be at higher risk of harm.
The group cited a 2010 survey of the public that found more than 80 percent of 1,200 respondents believe patients should be told if their resident has worked more than 24 hours. Those respondents also said they would want a different doctor.
"Both trials are highly unethical and fail to comply with key requirements of [federal] regulations for protecting human subjects," Carome said. "The potential harm does not outweigh any possible benefits of the research."