Harvey V. Fineberg, M.D., Ph.D.
President, Institute of Medicine
The National Academies
500 Fifth St. NW
Washington DC 20001
Dear Dr. Fineberg:
We are writing to express our dismay at a major public health opportunity missed by the Institute of Medicine (IOM): the failure to include any public policy recommendation regarding resident work hours in the IOM’s recent report on sleep disorders and deprivation. Moreover, the committee suffered from undeclared conflicts of interest, raising the possibility that these conflicts were partly responsible for the glaring omission of residency work hour reform from the report.
We greeted with great anticipation the publication of the Institute of Medicine’s “Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem” on April 4, 2006. As representatives of 65,000 U.S. medical students (American Medical Student Association), 12,000 resident physicians (Committee of Interns and Residents/SEIU), and a 100,000-member consumer advocacy group (Public Citizen), we are more than familiar with the toll that acute and chronic sleep deprivation takes on resident physicians and the patients for whom they care.
We had found the IOM’s seminal 1999 work, “To Err is Human,” largely silent on the role of sleep deprivation in preventable medical errors. We assumed the IOMwould rectify that omission in this new report, as it was focused solely on sleep and produced by a panel of experts chosen by the IOM. Indeed, one of the directives given to the IOM’s Committee on Sleep Medicine and Research was to “develop a comprehensive plan for enhancing sleep medicine and sleep research, as appropriate, for improving the public’s health. This will include interdisciplinary initiatives for research, medical education, training, clinical practice, and health policy.” (p. 35, emphasis added)
So, it was with shock that we read the Committee’s final 461-page report and found only a cursory 2½ pages devoted to resident physician work hours, with no recommendation of any kind for any change in health policy.
The report acknowledges that “Medical residents work longer hours than virtually all other occupational groups” (p. 173), yet, it grossly understates – by omission and error – the magnitude of the public health problem that this poses. There is, for example, no mention that there are more than 100,000 resident physicians in the U.S, or that:
- Punishing resident work hour schedules can continue, particularly in the surgical field for up to seven years;
- The Accreditation Council on Graduate Medical Education (ACGME) duty hour policy for maximum shift duration is not 24 hours, as stated (p. 174), but rather 24 plus an additional 6 hours “to participate in didactic activities, transfer care of patients, conduct outpatient clinics and maintain continuity of medical and surgical care as defined in Specialty and Subspecialty Program Requirements.” (https://www.citizen.org/sites/default/files/dutyhourscommonpr.pdf) In practice, the ACGME on-call shift limit is 30 consecutive hours and a resident can be scheduled to repeat this shift two to three times a week.
- In no other industry where human life is at risk – not in commercial trucking, airlines, or shipping – are work hours of this duration legal in the United States.
We contrast this extraordinary lack of detail with some 50 pages devoted to a discussion of the inadequate sleep medicine curriculum currently offered to medical students and residents and numerous Committee recommendations for improvement, e.g., “to ensure a high degree of recognition and the most effective clinical care, it is important that more training programs educate residents about the need for early detection and, whenever possible, the prevention of chronic sleep loss and sleep disorders.” (p. 232)
The irony here is unmistakable: a typical medical resident, having worked 24 consecutive hours, could then be required to go to her post-call morning clinic, where, straining to stay awake, she would carefully and conscientiously educate her patients on the dangers of not getting enough sleep. Then, after 30 consecutive hours in the hospital, she could climb behind the wheel of her car to go home, a “driving while drowsy” accident waiting to happen – to herself and those unsuspecting drivers on the highway with her.
It is difficult to understand the Committee’s lack of attention to the public health dangers posed by acute and chronically sleep deprived resident physicians – both in the hospital and on the road. There is a wealth of research on both subjects, much of it referenced in the report (e.g., the work of Dr. Charles Czeisler and his colleagues in the Harvard Work Hours Health and Safety Group). Dr. Czeisler, Chair of the Sleep Research Society, also addressed the Committee in person on April 11, 2004, and September 16, 2005.
Dr. Czeisler’s research should have been of great interest to the committee. In one study, his group demonstrated in a randomized, controlled trial (we doubt there are too many of these with hard outcomes in the sleep literature) that serious medical errors could be reduced by 26% if extended work shifts in the intensive care unit were abandoned.(Landrigan CP, Rothschild JM, Cronin JW, et al. Effect of reducing interns work hours on serious medical errors in intensive care units. N Engl J Med. 2004;351(18):1838-48.) In another, based on a survey of 2737 residents, house officers driving after an extended shift were 2.3 times as likely to report a motor vehicle accident as those not having worked such a shift. (Barger LK, Cade BE, Ayas NT, et al. Extended work shifts and the risk of motor vehicle crashes among interns. Engl J Med. 2005;352(2):125-34.) These well-designed studies have concrete implications for public policy, yet the committee opted to omit any related public policy recommendations. Certainly, the proof that reductions in work hours would prevent serious medical errors is considerably stronger than that underlying the great majority of the IOM’s recommendations.
Our second concern relates to conflict of interest. The IOM Committee of fourteen experts included twelve physicians. Of those twelve, six identified themselves as either current or past residency training program chairs or directors. These are people who not only know the hours that residents are scheduled to work, but are or were responsible for those schedules.
A simple Internet search revealed that two of the twelve physicians on the Committee were directly affiliated with the ACGME, although neither Dr. Robert H. Miller (an ex-officio member of the Otolaryngology Residency Review Committee), nor Dr. Charles F. Reynolds (a member of the Psychiatry Residency Review Committee) chose to disclose this in the biographical information included in the report. The failure of Drs. Miller and Reynolds to disclose their affiliation with the ACGME would appear to be in direct violation of the IOM’s policy on conflict of interest:
At the time of appointment, each committee member is required to list all professional, consulting, and financial connections…The information is also reviewed by officials of the institution, and if a potential conflict becomes apparent – which is rare – the committee member may be asked to resign. In exceptional circumstances, an individual may continue to serve on the committee if the conflict of interest is promptly and publicly disclosed, and The Academies have determined that the conflict is unavoidable. To fulfill our legal requirement for such public disclosure, The Academies post on their Web site a brief statement describing the unavoidable conflict.
Given the task before it, and the well-known, rigorous studies conducted by Dr. Czeisler and others, it was certainly not a stretch to expect that the IOM Committee charged with producing this report would carefully examine the ACGME’s voluntary work hour limits and issue recommendations accordingly. We wonder whether the presence of ACGME officials and residency program directors and chairs influenced the Committee’s decision to avoid making any recommendations at all.
The IOM has squandered an important and timely opportunity to highlight the significant dangers inherent in requiring the nation’s front-line caregivers to work consecutive hour shifts that a) scientists overwhelmingly agree are unsafe and b) are already not tolerated in any other industry. We are left with no other explanation but that a biased Committee refused to act on the evidence before it.
We ask that the IOM immediately begin work to rectify this serious lapse. The information already gathered by the IOM, together with other readily accessible information, could serve as the basis for another IOM report that would issue specific recommendations on resident work hours. At a minimum, the undeclared conflicts of interest of the Committee members must be included on the IOM’s website and any subsequent reprintings of the report. As your motto from Goethe so eloquently points out: “Knowing is not enough, we must apply; willing is not enough, we must do.”
Christopher P. McCoy, M.D.
Legislative Affairs Director
American Medical Student Association
Simon Ahtaridis, M.D., M.P.H
Committee of Interns and Residents/SEIU
Peter Lurie, M.D., M.P.H.
Public Citizen’s Health Research Group