More than an ocean separates European and United States ideas on appropriate working hours for trainee doctors. Nothing exposes the distance more than the pending changes to the European Union directive that regulates the trainees’ hours and recent recommendations from the influential Institute of Medicine in the United States. Critics of the changes on one side of the Atlantic and defenders of the IOM’s recommendations on the other sound a similar note.
Both sides recognize the dangers posed by fatigued doctors, and there is no want of hard evidence that they are error-prone. “A Bibliography of Articles on the Effect of Sleep Loss on Performance,” published in 2005 by the Accreditation Council for Graduate Medical Education (ACGME), explores the impact on safety of working overlong hours. Some 100 of the research papers look directly at the impact of sleep loss in resident physicians, which are known variously as doctors-in-training, junior doctors, hospital interns and residents.
Drunk With Fatigue
Some researchers reach for shock value. When they set their findings in a context offensive to public sensibilities they can count on media attention the world over. A case in point is a Brown Medical School and University of Michigan study that found fatigued medical residents’ performance on attention tests and on a driving simulator is comparable – or worse – than their performance after drinking three to four cocktails. Published in the September 2005 issue of JAMA, it was the first to compare residents’ sleep deprivation with alcohol ingestion – a standard of impairment long studied by researchers and easily recognized by the public.
In another study that was widely reported by the media, sleep researcher Charles Czeisler Ph.D., MD, noted that “working for more than 24 hours is hazardous.” In an article published in the Harvard University Gazette in January 2005, the director of the Sleep Medicine Division at Harvard Medical School explained that scores of studies show people who stay awake for 18 hours straight can have trouble thinking clearly and can zone out or nod off suddenly.
Czeisler and his colleagues had 2,737 first-year medical residents complete a monthly survey that asked detailed questions about their work schedule, sleep and days off. During the year-long study, the residents also were asked to report any medical errors they’d made while on duty. The researchers found that when residents reported working five marathon shifts in a single month, their risk of making a fatigue-related mistake that harmed a patient increased by 700 percent. And the risk of making an error that resulted in a patient’s death shot up by 300 percent. The report appears in the journal Public Library of Science (PloS) Medicine in December 2006.
“These data suggest there are tens of thousands of preventable injuries to patients annually,” said Dr. Czeisler.
Muscular European Approach
The European Working Time Directive (EWTD) is the European Union’s attempt to address fatigue-related risk factors head-on. First adopted in 1993, it lays down provisions for a maximum 48 hour working week (including overtime), rest periods and breaks, and a minimum of four weeks paid leave per year.
A number of areas, such as air, rail, road, sea, inland waterway and lake transport, sea fishing, other work at sea and trainee doctors were exempt in the 1993 directive. They were brought within its scope in an amendment agreed in 2000 and put in place for the trainees in August 2004.
There is an opt-out clause for member states. From 1 August 2009, however, opting-out won’t be allowed, and any period of on-call time, including inactive time, must count as working time.
The legislation has teeth. Violators could be fined the equivalent of UK £5,000 (US $7,125) for each infringement.
Rested Trainees Make Fewer Mistakes
One recent study looked indirectly at how many injuries could be prevented by ensuring the trainees worked the 48-hour limit compared to the 56-hour limit. Nineteen junior doctors working on the endocrinology and respiratory wards at the hospital participated in the 12-week British study by the University Hospitals Coventry and Warwickshire NHS Trust. Nine were put on a 48-hour per week pattern that met the EWTD conditions. Ten were on a traditional pattern in the United Kingdom, which has opted out of the EWTD, where they worked up to 56 hours.
The researchers found that doctors working to the 48-hour pattern made 33 percent fewer errors than their colleagues on the traditional 56-hour pattern, and there were fewer potentially life-threatening events.
When the opt-out provision is scrapped on August 1, EU trainee doctors will work to the 48-hour limit. Meanwhile, there is no sign US trainees will find relief any time soon from fatigue in a system that sees them working almost unlimited hours because of the country’s toothless regulations.
The ACGME governs trainee working hours in the United States. The body explains itself as the healthcare industry’s solution to internal professional regulation over federal regulation.
In 2003, the ACGME implemented work-hour limits for all resident physicians in the United States. Each trainee is limited to a maximum of 30 consecutive work hours, and a maximum of 80 weekly work hours, averaged over four weeks. In addition, one day in seven (averaged over four weeks) must be free of all duties.
The Institute of Medicine recently weighed in on the fatigue issue, and the organization’s recommendations emphasize the difference in ideas across the Atlantic about what constitutes appropriate rest from trainees.
Its December 2008 “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety” concedes physician fatigue contributes to increased errors and accidents and talks about revisions, but its table “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety” only taps around the edges of the working hours.
The IOM advocates no change to the present 80-hour limit per week, but some details have changed. It recommends a maximum shift length of 30 hours. It has changed its maximum in-hospital on-call frequency requirements from “every third night, on average,” to “every third night, no averaging.” Its recommended “minimum time off between scheduled shifts” adds a few more hours of rest time. Its “10 hours [of rest] after shift length” has been changed to “10 hours after day shift, 12 hours after night shift, and 14 hours after any extended duty period of 30 hours and not return until 6 am of next day.”
The IOM specifies a maximum frequency of in-hospital night shifts as “four nights maximum; 48 hours off after three or four consecutive duty.” They now have five days off per month (up from four); one 24-hour day off per week, with no averaging; and one 48-hour period off per month day.
In the United States, medical care is big business. Arguing that shortening doctors’ hours will increase costs, lobbyists have easily been able to block efforts to introduce federal regulation. The argument has “legs” because the system ensures that increased costs pass to patients and insuring bodies, which include the federal government.
Despite an unfavorable political climate, Congressman John Conyers, Jr, (D-Michigan) has persevered, twice introducing a patient safety bill that requires a participating hospital using “the services of physician residents or postgraduate trainees to limit their working hours to specified schedules.” Though the Patient and Physician Safety and Protection Act (2005) makes appropriations to the Secretary of Health to provide for additional payments to hospitals for their reasonable additional, incremental costs of compliance with the act, the proposed legislation is dead in the water.
Among other provisions, it protects whistle-blowing employees who report violations of working hour limits.
Data reported by the ACGME suggest that these limits succeeded in eliminating nearly all work weeks greater than 80 hours and shifts greater than 30 consecutive hours. Based largely on mandatory reports submitted to the ACGME by residency programs, the ACGME reported that only 5.0 percent of residency training programs were noncompliant with the standards in the year after their release, and that only 3.3 percent of surveyed residents reported violations of the 80-hour rule.
The ACGME regulations are toothless, and in a study published in the Journal of the American Medical Association (JAMA) in 2006, which challenged the ACGME data, Christopher P. Landrigan, MD, and colleagues found a much higher level of non-compliance. They said 1068 of 1278 of interns reported work hours in violation of the standards during one or more months, and that 67.4 percent worked shifts greater than 30 consecutive hours.
Holding the Line on Change
The research by Dr. Landrigan, Harvard sleep professor Charles Czeisler and many other suggests that even when US hospitals are compliant, the trainees are working dangerously long hours. Yet the critics of the EWTD and defenders of the IOM regulations have in common an aversion to changing trainee hours.
A quote from a trainee on the US side in 2003 helps to explain the aversion. Lauren Oshman, MD, described the trainees as “a source of cheap labor in hospitals, often working more than 100 hours a week with low wages and little time off.” She was speaking in Delaware in support of an attempt to regulate trainees’ hours, SB 133: Hospital Patient Protection Act House.
Collectively, the critics argue that the changes introduce unacceptable costs and an array of patient safety issues unrelated to fatigue. Implicit in the argument is that there will be little or no net gain in patient safety from trimming trainees’ hours. Definitive figures on the net gains seem to be lacking.
Opponents in Britain warn of dire consequences of removing the opt-out to the EWTD. A United Kingdom House of Lords committee report warned in January of a potential staffing crisis equivalent to losing 3700 junior doctors.
Arguing for preserving the opt-out, others say it increases flexibility in labor markets, particularly in difficult economic times. Business federations, in particular, have long argued that the opt-out is an important tool for companies to deal with fluctuations in demand.
Arguing for holding the line at 80 hours in the United States, the IOM notes that altering residents’ work hours alone … is not a silver bullet for ensuring patient safety. … “Many medical educators believe extensive duty hours are essential to provide residents with the educational experiences they need to become competent in diagnosing and treating patients.”
Financial costs and an insufficient health care work force are the biggest barriers to further revising resident hours, the IOM report notes. “Fatigue, spotty supervision, and excessive workloads all create conditions that can put patients’ safety at risk and undermine residents’ ability to learn,” said IOM committee chair Michael M.E. Johns, the chancellor of Emory University in Atlanta. “Health care facilities can create safer conditions within the existing 80-hour limit by providing residents regular opportunities for sleep and limiting extended periods of work without rest. But these steps should be supplemented by additional efforts to improve patient safety and ensure residents get the full experience they need to safely and competently practice medicine at the end of their training.”
Violations of the current limits on duty hours occur frequently and are underreported, the committee found. ACGME’s monitoring of training hospitals’ compliance with the limits should be strengthened by having more frequent visits and making them unannounced, according to the IOM.
The committee also called for greater supervision of residents by experienced physicians, limits on patient caseloads based on residents’ levels of experience and specialty, and overlap in schedules during shift changes to reduce the chances for error during the handover of patients from one doctor to another.
In Britain, the critics of removing the opt-out clause could succeed in engineering a postponement until 2012. In the United States, the IOM recommendations — for those hospitals that take them seriously — can be counted to bring slight relief to trainees.
Sources: AMSA; ACGME; IOM; BBC; Warwickshire NHS Trust; Europa; Harvard University Gazette;
Interns’ Compliance With Accreditation Council for Graduate Medical Education Work-Hour Limits. Christopher P. Landrigan, MD, MPH; Laura K. Barger, PhD; Brian E. Cade, MS; Najib T. Ayas, MD, MPH; Charles A. Czeisler, PhD, MD; JAMA. 2006;296:1063-1070.
This article originally appeared in The Ergonomics Report™ on 2009-02-04.