The Accreditation Council for Graduate Medical Education (ACGME) oversees all graduate medical education in the United States, including all accredited residency and fellowship programs. This group is independent but responsible to several key stakeholder groups, including the public, medical trainees, and medical professionals.
In 2003, responding to intense pressure from outside groups, the ACGME limited the duty hours of the trainees in accredited programs. In 2011, these regulations were modified again. The resultant duty hour standards include the following key components: residents are limited to 80 hours of work per week; first-year residents are limited to shifts no longer than 16 consecutive hours; and second-year residents are limited to shifts no longer than 28 hours. Residents must have 8 hours (but should have 10 hours) off between shifts, and they must have at least 1 day off per week.
Theoretical impact of duty hour rules on patient safety
The duty hour rules were implemented with two main goals in mind: to improve patient safety and to protect resident well-being. The theory behind the goal of improving patient safety is that residents who are excessively fatigued have a greater chance of committing errors that result in adverse patient events than residents who are well rested. Several studies support this theory. For example, performance on cognitive tests (1) and in laparoscopic surgery skills (measured via simulation) have been shown to be worse in sleep-deprived states.(2,3) Although some have argued that these "lab-based" studies do not induce the same attentiveness that real patient care does, interns working extended shifts have more electroencephalography-measurable attentional failures than those working shorter shifts.(4) In addition, those same interns working shorter shifts committed fewer patient care errors, even though patient adverse events were not different between the two groups.(5) Therefore, fatigue does seem to lead to less attention and also to errors.
Unfortunately, there is a relationship between working fewer hours and increased numbers of handoffs, another potential source of error. In a focus group of internal medicine residents, participants identified both fatigue and handoffs as contributors to errors.(6) Handoffs can lead to errors when written sign-out documents are not updated, are incomplete, or have inaccurate information.(7) Adding a face-to-face component, though theoretically attractive, does not necessarily alleviate the problem. In one stunning study of handoff quality, pediatric interns were unable to identify the key problem in 60% of patients they were cross-covering—even when referring to the written handoff documents.(8) Problems with handoffs have also been linked to near misses, inefficient care, and adverse events.(9)
What is the evidence regarding the impact of duty hours restrictions?
Empiric studies on the effects of the ACGME duty hour limits were synthesized in 2004 (10,11) and again in 2010.(12,13) At both times, the evidence suggested a modest improvement in resident well-being, but was insufficient to support strong conclusions regarding the effects on patient safety. Heterogeneity of study designs and outcomes is a key challenge precluding meta-analysis for most outcomes. Meta-analysis of studies examining patient mortality showed small but statistically significant decreases in mortality for medical and surgical patients following duty hour regulations; however, these findings could also be attributed to secular trends.(12) The largest single studies examining mortality, conducted by Volpp and colleagues, showed decreased mortality among medical patients cared for in Veterans Affairs (VA) hospitals, but did not show improvements for VA surgical patients or non-VA medical or surgical Medicare patients.(14,15) In summary, the literature still does not definitively tell us whether limiting duty hours improves patient safety.
Finding an answer to this question
Finding the answer to this question is not simple. We must first consider the outcomes that are really important. Of course, the safety of the patients presently being cared for in hospitals and clinics is of paramount importance. But what about the patients who are going to be cared for in 5, 10, or 20 years? Producing well-trained and suitably prepared doctors for future patients is as important as protecting the health and well-being of trainees and patients now. A policy that makes today's patients a bit safer at the cost of larger harm to patients later would not be optimal.
We must also acknowledge that the specific resident schedules used to comply with duty hour rules are likely to influence patient outcomes. This means that the local context (not just the schedules but the quality of the residents, the culture of the program, the availability of effective information technology, and more) may be just as important in determining outcomes as the national policy. Moreover, there are challenging methodological problems in outcome measurements to overcome. Studying important patient outcomes (e.g., mortality) is difficult, because of the (fortunately) low rates of these outcomes in any given hospital. Adverse events are more common, but more labor intensive, to measure since this usually requires detailed chart review. Errors are more common still, but rely almost entirely on self-report or intensive direct observation to identify.
To understand the effects of duty hour regulations on patient safety, new questions need to be addressed: Are we adequately preparing residents now to be capable independent physicians in the future? Do certain schedules, or other matters of culture, information technology, and leadership, lead to better patient outcomes than others? By focusing our research on these two questions, we can help move the medical education field forward by providing specific guidance regarding length of training and specific scheduling strategies. It is especially important to quantify gains in patient safety resulting from duty hour regulations given the tremendous cost of these reforms.(16) Getting the questions right will hopefully also help us get the answers right.
Kathlyn E. Fletcher, MD, MAAssociate Professor of MedicineClement J. Zablocki VAMC and the Center for Patient Care and Outcomes ResearchMedical College of Wisconsin, Milwaukee, WI
Darcy A. Reed, MD, MPHAssociate Professor of MedicineCollege of Medicine, Mayo ClinicRochester, MN
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