The Accreditation Council for Graduate Medical Education (ACGME) has given permission for hospitals participating in two new research trials to temporarily lift their duty hour requirements. The Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) study involves PGY-1 residents in internal medicine. The Flexibility In duty hour Requirements for Surgical Trainees (FIRST) trial will study all residents in general surgery, and its randomized controlled trials will test whether duty hour restrictions lead to better patient outcomes.

Why Were Duty Hour Restrictions Implemented?

Duty hour restrictions for residents can be traced to the death of Libby Zion in New York in 1984, when the combination of a MAOI and meperidine led to fatal hyperthermia. In 1989, following the recommendations of the Bell Commission, New York passed regulations limiting residents to 24 consecutive hours of duty and 80 hours per week. For a decade, these limits only applied to those training in New York, but that changed in 2003, when the ACGME instituted work hour restrictions across all specialties. These included a maximum of 80 hours per week averaged over four weeks (60 hours per week for emergency medicine) and no more than 30 consecutive hours of duty. In 2009, the Institute of Medicine (IOM) published a report titled Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.¹ The comprehensive work included a review of the science of human fatigue, including a look at data from other industries such as aviation and truck driving. Notable fatigue begins when a person has been awake for 16 consecutive hours.² For example, when comparing cognitive function, 17 hours of continued wakefulness equates to the impairment of a blood alcohol level of 50 mg/dL. Twenty-four hours without sleep is the equivalent of a blood alcohol level of 100 mg/dL, well above the legal limit.³

The IOM report called for more stringent resident duty hours than had been in place since 2003. In 2011, the ACGME responded by imposing the current work hour restrictions, including a 16-hour duty limit for PGY-1 residents. By focusing on fatigue as the cause of medical errors, the duty hours led to programs scrambling for patient care coverage and instituting shift schedules, dramatically increasing the number of handoffs.⁴

Essentially, medicine has traded errors from fatigue for errors in handoffs, and it has not made the patient experience any safer. Furthermore, limiting the time spent with patients and not extending the duration of residency training has made it more difficult for young residents to attain mastery. Due to electronic health record management and educational duties, only 12 percent of an intern’s time is spent in actual direct patient care.⁵ If it takes 10,000 hours to become an expert, residents will be well into post-residency practice before seeing enough patients to achieve expertise.

The Duty Hour Studies

There is a both an educational value and patient continuity benefit to permitting residents to work longer hours in the hospital. The iCOMPARE study will randomize hospitals to the current work hour restrictions versus allowing interns to work for 28 consecutive hours with a four-hour protected sleep period. Following a one-year study period starting in 2015, the hospitals will be reversed (a crossover design) and be followed for another year. The main outcomes will be 30-day mortality for patients and sleep duration for interns.

The FIRST trial begins this July and runs until June 2015. Participating hospitals will be randomized to the current restrictions versus more flexible duty hours. All residents (not just interns) in general surgery programs will participate, including off-service residents rotating in surgery. Hospitals in the intervention group will be permitted to eliminate all resident duty hour restrictions except the core limitations of 80 hours per week, minimum of one free day per week, and in-house call no more frequent than every third night. Other than that, anything goes. Presumably, some programs will use consecutive duty periods of 36 hours or more. This could potentially affect emergency medicine residents rotating on a general surgery service during the upcoming academic year. The primary outcome measurements will be patient death or serious morbidity.

It will be several years before we see the results from these studies. However, by permitting these randomized controlled trials to go forward, the ACGME and the medical education community is acknowledging that there may be value in having residents spend more time with their patients and that patients may benefit from improved continuity with hospital providers.

References

1. Institute of Medicine. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety. Washington, DC: The National Academies Press; 2008.

2. Van Dongen HPA, Dinges DF. Circadian rhythm in sleepiness, alertness, and performance. In: Kryger MH, Roth T, Dement WC, eds. Principles and practice of sleep medicine. 4th ed. Philadelphia, Pa: Elsevier; 2005:435-443.

3. Dawson D, Reid K. Fatigue, alcohol, and performance impairment. Nature. 1997;388:235.

4. Desai SV, Feldman L, Brown L, Dezube R, et al. Effect of the 2011 vs 2003 duty hour regulation-compliant models on sleep duration, trainee education, and continuity of patient care among internal medicine house staff: a randomized trial. JAMA Intern Med. 2013;173:649-655.

5. Block L, Habicht R, Wu AW, Sesai SV, et al. In the wake of the 2003 and 2011 duty hours regulations, how to internal medicine interns spend their time? J Gen Intern Med. 2013;28:1042-1047.

Dr. House is professor of emergency medicine at the University of Iowa and vice chair for education in the Department of Emergency Medicine.

Dr. Mutnick is a resident physician at the University of Iowa.