With the goals of reducing resident fatigue and improving patient safety, the Accreditation Council for Graduate Medical Education (ACGME) introduced physician trainee duty-hour restrictions in 2003 for all accredited residency and fellowship programs. Academic medical centers spent enormous amounts of money and time in recruiting additional midlevel providers and support personnel to implement, document, and monitor the new standards. Despite this substantial investment, there is no evidence that patients are safer from medical errors as a result of the 2003 regulations. More importantly, there is considerable concern on behalf of some physician leaders that these requirements have had a meaningful and detrimental impact on the future of our profession, not the least of which is the challenge of these external regulations to the ethos of professionalism1.
The U.S. Congress and the Agency for Healthcare Research and Quality in 2007 charged the Institute of Medicine of the National Academies (IOM) to further examine the issue of resident duty hours2. A Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedules to Improve Patient Safety was formed, and it reported its recommendations in 2009 (Table I). The report asserts that the cost to programs for personnel only would be 1.7 billion dollars (0.4% of Medicare expenses), yet additional funds for graduate medical education are not being appropriated. The Committee strongly urged Congress to support their recommendations with financial and human resources. Failure to provide necessary support for the recommendations could have the unintended effect of actually reducing patient safety3.
In response, the ACGME sought feedback from professional organizations involved in medical education in the fall of 2009 and subsequently formed its own committee, which made recommendations in June of 2010. After soliciting additional feedback, the ACGME issued final recommendations in September of 2010. Future congressional action may be to accept the proposed ACGME standards or to impose other requirements through other regulatory agencies.
What is clear is that the work-hour limitation is a critical issue that has forced the orthopaedic educator community to critically evaluate the key components of a “streamlined” resident education. It is important to our patients and to the future of our specialty to identify the most effective methods to both educate residents and evaluate their acquisition of essential knowledge and skills. It is equally important to foster an educational environment in which professional behavior is valued, modeled, and imprinted in the resident or fellow. A symposium was held at the Annual Meeting of the American Orthopaedic Association in June 2010, featuring three perspectives on work-hour restrictions: Dr. Nestler provided insight into the ACGME response to the IOM; Miss Marx shared the British experience with competency-based education in light of even more stringent work limitations for surgeons and trainees in Great Britain; and Dr. Pellegrini discussed the adverse effects of duty-hour regulation on professionalism.
The ACGME is the accrediting body for all residency and fellowship programs in the U.S. It is an independent, private, and nonprofit organization. Its member organizations include the American Medical Association (AMA), American Hospital Association (AHA), American Board of Medical Specialties (ABMS), Association of American Medical Colleges (AAMC), and the Council of Medical Specialty Societies (CMSS). Policies are determined by a Board of Directors nominated by these organizations. ACGME accreditation of a residency or fellowship is required to receive federal funding and is necessary for specialty board certification in most medical specialties.
The IOM, in contrast, is an independent, not-for-profit arm of the National Academies that provides health advice to the public and the government. Many work products of the IOM are mandated by the U.S. Congress. Approximately 2000 volunteers participate in various committees charged by the Agency for Healthcare Research and Quality (AHRQ) to address issues of quality and safety in health care. The report “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety,” released in December 2008, is one such effort. It suggested that substantial revisions to resident duty hours and workload are needed to better protect patients from fatigue-related errors and to enhance the learning environment for doctors-in-training. The recommendations in this report included improvements in ACGME monitoring and the suggestion that the Joint Commission or the U.S. Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), might need to assume responsibility. Coincidentally, as part of the original 2003 resident work-hour requirements, the ACGME had stipulated that the impacts of the standards, including the eighty-hour workweek, be carefully evaluated after five years4. Consequently, in September of 2008, the Board of Directors of the ACGME appointed a sixteen-member task force. On this task force were fifteen physicians: six from surgical specialties, six from medical specialties, and three from hospital-based specialties. There were three residents and one nonphysician member. The task force was charged to gather information, comment regarding the 2003 requirements, and propose new standards for ACGME review5.
Data and opinion-gathering began in December 2008. There were Internet-based surveys of residents, program directors, faculty, and institutional officials. During 2009, the task force received written submissions from 140 medical organizations, including the American Orthopaedic Association (AOA) and the American Academy of Orthopaedic Surgeons (AAOS). It heard oral presentations by more than 100 representatives of national groups, including the AOA, representing the broad spectrum of medical specialties, resident and student organizations, and government agencies, as well as medical educators from Canada and Europe.
The task force found no evidence of meaningful change in patient outcomes since 2003, no decrease in medical errors, and no documentation of residents getting more sleep. The data showed that duty-hour violations were, in fact, a problem in very few specialties or institutions. The task force concluded that the issue of patient safety was complicated and related only in part to duty hours. The task-force analysis identified several principles and conclusions (Table II) that resulted in proposed revisions to the 2003 requirements6; the proposed revisions were submitted for ACGME review in June 2010 and then approved for circulation and comment6. Key components of the recommendations of the task force are included in Table III.
The final work of the duty-hour task force included review of the comments received in response to the recommendations circulated in June 2010. Most specialties, as well as the public, responded with written opinions during the ACGME call for comment. A coalition of patient advocacy groups, including Public Citizen, and groups representing medical students and residents, including the Committee of Interns and Residents (CIR) of the Service Employees International Union, opined that the proposed changes did not go far enough. CIR joined Public Citizen, the American Medical Student Association, and several professors from Harvard Medical School and Albert Einstein College of Medicine in calling on the Occupational Safety & Health Administration (OSHA) to assume jurisdiction over the work hours of residents.The WakeUpDoctor Coalition (http://www.wakeupdoctor.org) gave the ACGME’s new requirements a grade of “F” and joined a petition to the U.S. Department of Labor7.
Despite these concerns, the ACGME issued a final recommendation with only modest revision in September 20106. The most substantive changes involve postgraduate year-one (PGY-1), limiting work to sixteen hours of continuous duty and mandating the presence of direct supervision. All residents continue to be restricted to an eighty-hour weekly maximum and a six-consecutive-night maximum on night-float rotation. Averaging is allowed with regard to the frequency of days off and frequency of in-house call. Detailed supervision requirements became effective on July 1, 2011. Several issues remain to be clarified by the individual residency committees in the next several months. It is apparent to all in graduate medical education that the hours available for residents to acquire the necessary knowledge and skills to be safe practitioners of medicine have substantially contracted. Among changes that surgeon-educators must consider is a “competency-based” curriculum for surgery education.
In the early 1990s, United Kingdom (U.K.) trauma and orthopaedic surgeons with an interest in education started to examine systems for agenda setting, learning agreements, competency assessment, and portfolio assessments in addition to working on a defined syllabus. At that time in the U.K., training lasted eight to ten years depending on the specialty, with much of the service being delivered by trainee doctors, some of whom had poorly developed skills and little support or supervision. Patient safety considerations provided a real impetus for change.
In response to these concerns and in an effort to enhance education, the British Orthopaedic Association (BOA) established the Orthopaedic Competence Assessment Project (OCAP) in 1995 and produced a syllabus in 1999. The training committee formally introduced paper-based recording of learning agreements and the accompanying workplace procedure-based assessments (PBAs). These formed the building blocks for the curriculum published in 20068. In addition, the Royal College of Surgeons Edinburgh “e-logbook,” which has been compulsory since 2003, simplified the recording of trainer and trainee involvement in operative procedures (with >10 million operative procedures recorded in the first ten years of the compulsory program) and recently made it possible to also record learning agreements and electronic PBAs. Since August 2008, all training in the U.K. has been against the background of competency-based curricula and has included clear standards for trainers and trainees.
Restricted working hours has been a fact of life in the U.K. since 1991, when hours were limited to seventy-two hours on call or fifty-six hours in shifts. In 2003, the actual hours worked were reduced to fifty-six hours for all doctors by the European Working Time Directive (EWTD). This restriction and the knowledge that by August 2009 there would be a requirement for doctors to work no more than forty-eight hours a week on the average (with an individual opt-out to fifty-six hours), with well-defined rest periods, produced a move in some hospitals from the traditional on-call system to shift patterns of work. Using the e-logbook data, Jameson et al. were able to show that when shift patterns were introduced simply to cover service and without regard for educational activity there was a measurable reduction in trainee workload (particularly at the more junior levels) of more than 25%, with most of the reduction coming from decreased exposure to daytime elective procedures9. This analysis predated the introduction of the mandatory curriculum in August 2008.
David Pitts, the BOA Education Advisor, led the way in pointing out that a paradigm shift was required to move away from a system that placed service delivery at the center of the universe for teaching departments and to move toward a system that focused on the requirements of training, in which the trainee’s educational needs overlap those of service delivery. The advent of the curriculum focused attention on trainee learning objectives and educational requirements and the necessity to use assessment tools to record progression through stages of training. Overall, in the fifteen years since competency assessments and OCAP began, there has been a steady acceptance and acknowledgment that a competency-based focus has improved the structure and delivery of training.
The logbook has been used to assess changes in operative experience over the last six years. There are now data from the e-logbook that look at the operative experience in three consecutive years, 2007 to 2009, during the three months from August through October and in each of those years as compared with the previous three years of the training grades10. This shows that, despite the fact that an increasing number of trainees are working shorter hours, the amount of individual operative experience has slightly increased, particularly in the elective area, indicating a refocusing of attention to ensure maximum exposure to operative experience. As yet, the full effects of the August 2009 implementation of the EWTD of forty-eight hours have not been fully appreciated.
It has become apparent that those exiting training today have the skills and competencies but not the experience that accompanied the long duty hours of previous trainees. It is therefore necessary to consider what mentoring arrangements are required as these young specialists enter the independent workforce.
Changes in practice will be required to ensure patient safety in a period of reduced working hours. The U.K. experience of changing the reimbursement for treating patients with a femoral neck fracture has shown how setting best practice standards, which demand a change in the way care is delivered, improves care. With regard to patients with femoral neck fractures, the involvement of trained “Care of the Elderly” physicians (i.e., geriatricians) rather than reliance on junior surgeons-in-training to deal with the complexities of polypharmacy and complex medical problems has improved outcomes and reduced length of stay and cost during a period of reduced working hours.
The new generation of junior doctors in the U.K. will only ever have worked forty-eight hours a week when they enter surgical training. They have a different focus in their lives; family considerations and lifestyle are important. The British government commissioned Sir John Temple to analyze the state of medical training. In May 2010, he concluded that high-quality training could be delivered in forty-eight hours, but that “this is precluded when trainees have a major role in out of hours service, are poorly supervised and access to learning is limited.”11
The simple conclusions were that (1) service should be delivered by trained specialists; (2) where time is limited, every moment has to be a learning opportunity; (3) service delivery must explicitly support training; and (4) trainers should be recognized, developed, and rewarded. Ultimately, it is for us to ensure that we focus our attention on the proper preparation of the next generation, their training, and their skills.
Effects on the Profession
The movement to formalize regulation of physician-trainee work hours was motivated by a concern regarding patient safety that originated with the lay public12. Throughout this crusade, which has now spanned nearly a decade, the goal of high-quality postgraduate medical education has, until very recently, been only peripherally on the pro-reform agenda3. As we reflect on experience with the first three full classes of orthopaedic trainees educated under the new system of work-hour restrictions, the evidence for improvement in patient safety remains elusive while the adverse impact on surgical education and the ethos of professionalism seems much more palpable.
There are three fundamental issues central to a discussion of physician-trainee duty-hour guidelines, as well as the reaction to efforts to put guidelines in place, which are universally applicable to all orthopaedic communities despite variation in the actual rules in each country. Driving this reform are the central issues of patient safety and the occurrence of medical errors related to fatigue of the treating physician. In reaction to this duty-hour dilemma are two additional issues: the realization of the need for a transition to competency-based surgical education from the present time-defined training periods, and a heightened awareness of the erosion of medical professionalism. Indeed, one might reasonably suggest that the central issue of work-hour guidelines is a mere surrogate for a substantive discussion of these three important tenets of medical education.
As we embark on this discussion, it is valuable to consider the subject in a global context1. Currently, the U.S. has one of the more “liberal” duty-hour guidelines, with an eighty-hour weekly maximum. The EWTD, which became law in 2004 when it reduced the working hours for junior doctors to fifty-eight hours per week, now mandates a maximum of forty-eight hours13. While generally governed by the EWTD, the U.K. offers an “opt-out” to fifty-six hours per week for surgical trainees. In support of this stance, the Association of Surgeons in Training (ASiT) projected that the initial reduction accounted for a 20% decrease in exposure to operative cases and that the second reduction to forty-eight hours accounted for another 25% decrement, for a nearly 50% overall reduction in elective case volume since the introduction of the EWTD14,15. Similarly, the British Orthopaedic Trainees Association (BOTA) has called the full implementation of these guidelines a “threat to the safety of patients” by providing for a cadre of future consultant orthopaedic surgeons with a “level of expertise … that will undoubtedly be significantly inferior to that currently taken as the minimum standard”16. It has called on the government to pass urgent legislation that would allow a profession-wide opt-out of the restrictions such that the average weekly contracted hours may be increased to sixty-five. Ironically, BOTA has noted that, by forcing doctors into shift work, the EWTD restrictions have caused home and family life to suffer as well, despite an overall reduction in the proportion of the week spent at work. Currently, the Department of Health offers a voluntary plan that provided all doctors, including consultants as well as registrars, a one-time opt-out from the forty-eight-hour rule back to the fifty-six-hour limit that was in effect when they began working at their new posts in August 2009 as beginning residents. The Royal College of Surgeons has concurrently called for a “surgical opt-out” of the European legislation to achieve a sixty-five-hour workweek as suggested by the BOTA17. The Royal Australasian College of Surgeons (RACS) mandates an eighty-hour maximum, which logically (but uniquely) applies to trainees as well as Fellows of the College18. Interestingly, work-hour restrictions for trainees have not included staff physicians in most countries. However, the RACS statement, coupled with a physician shortage in Australia, has ironically led to the unintended consequence of senior staff physicians working somewhat longer hours to maintain continuity of patient care. The Health Professions Council of South Africa has limited trainees to fifty-six hours per week and no more than thirty hours continuously. However, registrars can elect to work paid overtime up to eighty hours weekly and there are no such regulations for specialists under state employment or in the private sector. Canada remains more flexible in its approach; provincial limits are loosely defined and still make it possible to work eighty hours per week in most areas, although resident physicians in Ontario have recently pursued enforcement of work-hour limitations through the court system19.
An observed decrement in cognitive function attributable to fatigue-related issues, as extrapolated to the sleep-deprived house officer, is a principal catalyst to this discussion. However, experience now suggests that house officers do not get more sleep as a result of work-hour limits, but do have less depressive illness, enjoy better work-life balance, and are being educated about fatigue management and how to perform under stressful conditions5. Standardized test scores have not increased and there are no data to suggest a reduction in medical errors since the ACGME introduced work-hour guidelines in 2003. “Fitness for duty,” as measured according to cognitive and technical performance, is more closely related to hours slept than hours worked, and measurement of the latter is not a reliable surrogate for the former.
However, since the implementation of duty-hour limits it has become apparent that medical errors are associated with handoffs in care, which are increased as a by-product of reduced work hours and more frequent shift changes. Models, such as “team-based” care, that reduce handoffs have been shown to reduce related errors, but the projected expense associated with their widespread implementation is substantial. The “value” of care continuity then takes on a multiplicity of meanings; there is quality value in reduction of medical errors through provision of greater continuity and fewer handoffs in care, there is educational value in experiential adult learning through witnessing the evolution of disease that affords correlation of symptoms with pathology, there is medicinal value for the patient in development of a therapeutic relationship with an assigned house officer, and there is economic value implicit in the cost of replacing the continuity of care that was previously provided by house officers on extended shifts.
Finally, a longer-term view of patient safety must take into consideration the ability of our current physician trainees to practice independently on graduation from their respective residency programs. Nasca4 referred to this as “indirect patient safety” and advocated for a supervised progression of responsibility during residency (i.e., increasing responsibility while decreasing supervision) to ensure competence on graduation. And so, as we limit prolonged resident exposure to patient care during resident education in the name of patient safety, we must be ever mindful that eventually these trainees will ultimately be responsible for the welfare of their own patients. It must be remembered that we retain an obligation to provide trainees with sufficient education and experience to ensure their competency in medical practice on completion of an accredited residency program. This broader view of patient safety dramatically increases the complexity of the safety issue.
“I hear and I forget. I see and I remember. I do and I understand.” (Confucius, 551 to 479 BC)
A substantial benefit derived from the patient safety imperative is the stimulation of a closer look at postgraduate medical education and recognition of the need to redefine the optimal learning environment for resident physicians. The need to progressively grant resident physicians graduated responsibility in concert with diminishing supervision has been openly articulated but recently compromised by tighter “teaching physician” supervision rules, the Physicians at Teaching Hospitals (PATH) audits, strict risk management policies, and compliance and clinical-productivity pressures on teaching faculty. Collectively, these events have contributed to further removal of the resident from assuming an essential and accountable role in providing patient care—a role that fosters a highly concentrated learning experience. Certainly, in teaching a technical (as well as cognitive) surgical specialty, the hands-on experiential component is critically important20.
Consequently, in the face of such substantial changes in the nature of residency education, the obvious realization is that residency must become more competency-based rather than time-based. Development of proficiency milestones and their assessment, prioritization of the role of the resident as student rather than employee, and the “customization” of programs of residency education will all improve the overall process but will require a major overhaul of the present system. The Carnegie Foundation for the Advancement of Teaching has recently called for “drastic reconsideration” of North American medical education, prompted by the realization of a need to “adapt to students’ interests and learning styles” in contemporary adult education21. Implementation of such an approach will likely shorten residency education in some specialties while extending the period of residency in others, and those specialties inclusive of a technical as well as a cognitive component will predictably see an increase in training time.
“The practice of medicine is an art, not a trade; a calling, not a business; a calling in which your heart will be exercised equally with your head.” (Sir William Osler, 1903)
Perhaps most troubling to seasoned educators, particularly in the context of a failure of work-hour restrictions alone to deliver the anticipated reduction in medical errors, is the perceived erosion of the ethos of medical professionalism that a “shift-worker” and “clock-punching” mentality encourages. We teach our residents that, as physicians, our efforts should be limited by neither time nor money when a patient is in need of care that we are able to provide. We applaud and nurture the willingness to sacrifice self-interests in deference to a patient’s needs; indeed, we expect such altruism from medical professionals. However, this behavior is not what our guidelines have come to legislate; they mandate residents to leave the patient’s bedside when a shift has ended.
We are left to ponder the ethical conundrum of “duty-hour patient-caring,” in which the conflict between the altruistic behavior of placing the patient first is met with the legislated behavior of ending a scheduled duty shift on time. Although a resident may possess the (correct) instinct to remain with an ill patient, our regulations demand that the work shift be completed as scheduled within duty-hour constraints. Simply stated, what we instinctively desire of medical professionals is not the behavior that our rules demand and enforce. Indeed, we have created a paradox in which we are neither modeling nor mandating what we hope to have our residents practice as responsible and ethical physicians.
Despite the popular analogy of the airline industry and its heralded work-hour restrictions for pilots, it fails miserably as a model for work-hour limits for either medical trainees or seasoned practitioners. The oversight of patient care during the evolution of an illness is not as readily substituted as the captaincy of an aircraft on a scheduled flight. Specifically, the inconvenience to the passenger of a flight delayed to accommodate a fresh crew change is not an appropriate comparison with the potentially life-threatening compromise in information transfer that occurs with a handoff in oversight of patient care. To further abuse the analogy, a better comparison might be an in-flight pilot change during a storm rather than a crew change on the ground between scheduled flights.
As advocated by Nasca, our teaching programs must nurture professionalism and the effacement of self interest that is the core of the practice of medicine and the profession.5 The evidence to date suggests that work-hour restrictions based solely on clock-defined time limits discourage, rather than promote, the professional behavior that we desire in tomorrow’s physicians. Notwithstanding any issues related to duty hours or fitness for duty, a competency-based system of medical education is both desirable and necessary in the current environment of medical education. In the absence of evidence to suggest that duty-hour limits reduce medical errors and enhance patient safety, and until we have evolved to a competency-based system of resident education, a misguided and overzealous focus on limiting work hours should not be allowed to exert the unintended consequence of eroding the ethos of professionalism that we, and our patients, have come to expect of a physician.
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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, one or more of the authors has had another relationship, or has engaged in another activity, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.