Since 2003, strict rules have limited how long medical residents can work without a break. The rules are supposed to minimize the risk that these doctors-in-training will make mistakes that threaten patients' safety because of fatigue.
But are these rules really the best for new doctors and their patients? There's been intense debate over that and some say little data to resolve the question.
So a group of researchers decided to follow thousands of medical residents at dozens of hospitals around the country.
The study compares the current rules, which limit first-year residents to working no more than 16 hours without a break, with a more flexible schedule that could allow the young doctors to work up to 30 hours.
Researchers will examine whether more mistakes happen on one schedule or the other and whether the residents learn more one way or the other. The yearlong study started in July.
"If we want to take the best care of patients now and in the future, we really need to understand much more about the intricate balance of hours, education and care," says David Asch, a professor of medicine at the University of Pennsylvania, who is leading the study.
But this study and a similar project have triggered objections from Public Citizen's Health Research Group, an advocacy organization based in Washington, D.C., and the American Medical Student Association, which represents medical students.
The groups argue the studies put patients and residents at risk.
Sleep-deprived residents are more likely to injure themselves while doing procedures such as drawing blood, inserting intravenous lines or suturing wounds, says Michael Carome, who heads the health research group. The accidents could lead to infections with viruses such as hepatitis and HIV, he says. And tired residents tend to get into more car accidents after work.
He argues that the studies raise concerns about patients, too.
"Tired residents are more likely to make mistakes when they're caring for patients," Carome says. "And those mistakes in some cases can lead to catastrophic complications and even death."
A well-known example is the 1984 case of Libby Zion. Zion was a college freshman who died at a New York hospital while being cared for by residents. Other cases in which patients were harmed or even killed by mistakes made by tired residents finally resulted in the new work rules, which were adopted in 2003. These rules were revised in 2011, adding the 16-hour restriction for first-year residents.
Because longer hours are so risky, Carome argues, the studies are unethical, especially since the researchers are not being required to ask the residents or the patients for permission to include them.
"Patients are not being informed at all, so the patients are completely unwitting subjects of this research," Carome says. "The residents are aware that they are in this trial, but they have no choice to participate unless they want to leave the residency training program."
That's the case for David Harari, a first-year medical resident at the University of Washington Medical Center in Seattle. He knew his hours would be grueling but says he was shocked when he discovered he may have to work 30 hours straight.
"I can't see how anyone could work optimally with such little sleep," Harari says. "It's extremely difficult to stay awake, stay alert and function optimally at that level."
Harari was offended by the fact he had no choice in the matter.
"Being asked to partake in a study in which I never provided informed consent felt extremely unethical and really uncomfortable," Harari says.
Carome argues hospitals are pushing to relax the rules to save money. But Asch argues that the research is needed to determine which schedule is safest and teaches residents the best. Longer shifts may actually be safer than shorter shifts, he says, because shorter shifts can lead to more night shifts, which can be even more fatiguing than long shifts.
And, Asch says, mistakes often occur when residents have to hand off their patients to other doctors because a rigid schedule forces them to go home.
"The new doctor taking care of you never knows you as well as the doctor who was taking care of you before," Asch says. Information handoffs are "like in a relay race, where the baton gets dropped between two runners. And it's known as a critical point where medical errors are common."
Asch also maintains that it isn't practical to get consent from all the doctors and patients in the study. Some independent bioethicists agree.
"They're asking important questions that we need to answer in order to create competent doctors, and I think they're doing it in an ethically sound manner," says Mildred Solomon, who heads the Hastings Center, a bioethics think tank.
The federal Office for Human Research Protections is reviewing the complaints about the studies, according to a spokesman.
STEVE INSKEEP, HOST:
Today in Your Health, we'll ask how to keep your doctor awake enough to keep you alive. A hospital is a 24-hour operation. A life-or-death decision can come at any moment, and hospitals have struggled for years with how to stay staffed. They've worked young doctors for so many hours they can hardly stand and also tried to strictly cut back on those hours. Now a study is trying to find out what really works and the answer may be less obvious than it seems. NPR's Rob Stein is here, and, Rob, aren't people just less tired if they work shorter hours?
ROB STEIN, BYLINE: You know, Steve, you'd think so, but there are a lot of factors here. We're talking about residents. These are young doctors. They just graduated from medical school. They continue their training by caring for patients in hospitals. This is what happens all over the country. They're now covered by really strict rules regulating their work hours, which sounds great, right? Well, they're - researchers out there like David Asch at the University of Pennsylvania are asking is that really true?
DAVID ASCH: What happens with short shifts is that then you put residents on, for example, night float rotations. You have to cover patients 24/7. And it turns out that night shifts are also potentially fatiguing.
STEIN: Maybe even more fatiguing than working just one very long shift. And Asch says a lot of mistakes happen when residents have to hand off their patients to other doctors because the rigid schedule forces them to go home.
ASCH: Handoffs represent a break in the continuity of care. The new doctor taking care of you never knows you as well as the doctor who was taking care of you before. That's an opportunity sort of like in a relay race where the baton gets dropped between two runners. And it's known as a critical point where medical errors are common.
STEIN: So Asch decided to do a big study with thousands of medical residents at dozens of hospitals around the country. The study compares shifts that must end after 16 hours for the youngest doctors with a more flexible schedule that could let residents work up to 30 hours straight.
ASCH: It's motivated by an understanding that, you know, if we want to take the best care of patients now and in the future we really need to understand much more about the intricate balance of hours, education and care.
STEIN: So the study will see which schedule works best, both for the patients and the young doctors, whether more mistakes happen on one schedule or the other and which way the residents learn best. But it's controversial. Michael Carome heads an advocacy group called Public Citizen's Health Research Group. He says the study is too risky for the young doctors.
MICHAEL CAROME: When they become sleep deprived and they're drawing blood or putting in IVs or suturing the skin, they're more subjective to injuring themselves. So, like, poking themselves with a needle and that could expose them to, like, hepatitis B or hepatitis C or the AIDS virus, HIV. And when residents, after their shifts end, go to drive home, they are at increased risk of having motor vehicle accidents.
STEIN: And, Carome says, those long shifts are dangerous for their patients, too.
CAROME: Tired residents are more likely to make mistakes when they're caring for patients. And those mistakes, in some cases, can lead to catastrophic complications and even death.
STEIN: Because it's so risky, Carome argues the study is unethical because the researchers don't ask the residents or the patients for permission to include them.
CAROME: Patients are not being informed at all, so the patients are completely unwitting subjects of this research. And the residents are aware that they are in this trial, but they have no choice to participate unless they want to leave the residency training program.
STEIN: That's the case for David Harari. He's a first-year medical resident at the University of Washington Medical Center in Seattle. He knew his hours would be grueling, but not 30 hours straight.
DAVID HARARI: I can't see how anyone could work optimally with such little sleep. Certainly after the, you know, 16, 17, 18 hours of being up, your body feels it, and it's extremely difficult to stay awake, stay alert and function optimally at that level.
STEIN: And he doesn't like the fact that he had no choice in the matter.
HARARI: Being asked to partake in a study in which I never provided informed consent felt extremely unethical and really uncomfortable.
STEIN: But the researchers argue we to find out once and for all what schedule works best. And it's just not practical to get consent from all the doctors and all the patients in this study. And some bioethicists agreed. Mildred Solomon heads the Hastings Center, a bioethics think tank. She's not involved in the study.
MILDRED SOLOMON: They're asking important questions that we need to answer in order to create competent doctors. And I think they're doing it in an ethically sound manner.
STEIN: Now, Steve, a couple of advocacy groups have filed an official complaint about this study, so the federal office that polices medical research is looking into it.
INSKEEP: Well, let me ask a bottom line question about this research, Rob Stein. Are they putting people at risk of death, a greater risk of death, just to test the effect of longer hours?
STEIN: Well, that's the central question here. That's the central question in this debate. And the researchers who designed this study and other people who I've talked to about this say no, they're not, that the research that's been done since these new rules were put in place are very mixed, but there's no indication that these changes in the shifts would really increase the risk for patients or the residents.
INSKEEP: Is it fair to say, though, that they're rolling the dice because they don't know what the effect will be? It's a study.
STEIN: Well, you know, what this study has been deemed is what they call a study that poses minimal risk. That's why they were able to go forward with it and do it without getting informed consent from the - either the residents or the patients. Now, the critics say, you know, that's not true, that there is clear evidence that if you make residents work these much longer hours and it's much riskier for them and their patients. So that's what this debate is all about, and we'll have to see what the outcome of it is.
INSKEEP: So is it possible that people in many fields could eventually find out that in certain circumstances working longer hours could make them less tired than the alternative?
STEIN: Well, that's a possibility and that's clearly one of the things they're testing here. You know, lots of people work crazy hours. Truck drivers work crazy hours and that can put them in life-or-death situations. Radio hosts work crazy hours...
STEIN: ...And that can put them in very stressful situations. But, you know, we really don't know the answer to that question at this point. But what we do know is that sleep is very complicated, and it's not necessarily just how many hours you work. It could be how those hours are spaced out, what those hours are, what time of day you're working them. So that's clearly one of the questions that we need to get the answer to, and that's what this study is trying to find out.
INSKEEP: Rob, get some rest.
STEIN: I'll do my best.
INSKEEP: That's NPR's Rob Stein, and that's Your Health for this Monday morning. Transcript provided by NPR, Copyright NPR.