(Circulation. 2008;118:532-537.)
© 2008 American Heart Association, Inc.
Controversies in Cardiovascular Medicine |
From the Division of Cardiology, Duke University Medical Center, Durham, NC.
Correspondence to Thomas M. Bashore, MD, Box 3012, Duke University Medical Center, Durham, NC 27710. E-mail thomas.bashore{at}duke.edu
| Introduction |
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The best lad schemes o mice an menGang aft agley,
An leae us nought but grief an pain,
For promisd joy!
— —Robert Burns
| The "Best Lad Scheme" |
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Response by Kuvin p 537
In the 1950s, Residency Review committees were created for many specialties to set standards for and to evaluate residency programs in those specialties. In contrast to specialty boards that examined trainees at the completion of residency training, the review committees evaluated and accredited programs within individual specialties. In 1965, with the US Congress approval of the Medicare Bill and public support for graduate medical education (GME), the door was opened for GME policies to be subject to public policy. In 1972, the Coordinating Council on Medical Education (CCME), charged with approving and coordinating all areas of medical education, was born from 5 organizations: the American Medical Association, the American Board of Medical Specialties, the American Hospital Association, the Association of American Medical Colleges, and the Council of Medical Specialty Societies. The goals of the CCME were not achieved because of the multiple levels of bureaucracy with challenging reporting and approval processes. Despite, or perhaps because of, this bureaucracy, regulatory efforts were generally directed at program organization, and the oversight was usually cordial, mutual, and not very intrusive; most programs were allowed to function with minimal regulations as long as it was perceived that acceptable training was being accomplished. In 1981, CCME was disbanded, and the Accreditation Council for Graduate Medical Education (ACGME) was created, whose stated mission is, "We improve health care by assessing and advancing the quality of resident physicians education through accreditation."
After the formation of the ACGME, however, certain events have led GME "gang aft agley." First, in 1984, the unfortunate death of a young woman, Libby Zion, was blamed on a medical error by a resident in internal medicine who had prescribed meperidine (Demerol) for rigors related to fever. The drug resulted in a serious interaction with the monoamine oxidase inhibitor that she had been taking for depression. This medical misstep was attributed to the residents fatigue and inadequate sleep at New York Hospital.3 A grand jury trial recommended limiting resident work hours to improve patient care, and in 1987, the New York State Commissioner appointed a committee that recommended major regulatory changes in residents duty hours. New York adopted the Bell Commissions regulations that limited resident work hours to 80 per week beginning in July 1989.
The ACGME followed this lead. Facing a threat to their own authority from the Occupational Safety and Health Administration (OSHA), from legislation proposed by Michigan congressman John Conyers, Jr, based on the Libby Zion case, and a potential lawsuit from residents who were organizing unions at the time, the ACGME stepped in and limited work hours. In July 2003, the mandate became effective despite a lack of any data that such a limitation would prevent medical errors. Because the loss of accreditation of a training program meant that its trainees were not eligible to take the certifying examination for the specialty, programs were forced to comply. In addition, programs that lost ACGME accreditation were not considered eligible for Medicare GME funding. Thus, the ACGME gained enormous clout over training programs and had the teeth to enforce compliance.
A second seminal event occurred in 1999 when the ACGME sought to improve GME by standardizing outcome measures and endorsed 6 general core competencies as part of the Outcomes Project: patient care, medical knowledge, practice-based learning and improvement, professionalism, interpersonal and communications skills, and system-based practice.4 Paraphrasing the Burns poem above, "promised joy," in the eyes of the ACGME, is to "improve health care by assessing and advancing the quality of resident physicians education through accreditation." The ACGMEs path to this well-intentioned goal is based on achieving physician competence, defined as the "habitual demonstration of the 6 competences in actual daily life."5
For the fellow training in any specialty, including cardiovascular medicine, the 4 assessment tools that "should dominate the model [are]: portfolios of clinical experience, direct observation of the trainees, cognitive tests, and assessments by patients, peers, and professional associates (a 360-degree evaluation)."6 Thus, these assessment tools were instituted as the means to build the competence of the practicing cardiologist. The ACGME began to add considerable additional requirements to each training program in the hope of improving the educational experience, physician competence, and ultimately patient outcomes. Unfortunately, despite grumbling from program directors that the mountains of work needed to accomplish some of this seemed without demonstrable merit, there was little any specialty and certainly no individual program could do except comply.
At the same time the ACGME began requiring more and more documentation, academic medical centers were evolving and responding to the additional documentation requirements heaped on them by both the research industry and the clinical practice of medicine. In the last couple decades, professional dollars have dwindled, forcing clinical teachers to ramp up the business of medicine to pay the bills. This shift has resulted in a steadily progressive tsunami of paperwork now required to document every clinical decision. In the setting of greater clinical demands and increased requirements for documentation, the time and energy dedicated to teaching trainees and assessing competence have become increasingly limited.
| "Grief an Pain for Promised Joy?" |
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As stressed by Ciolli,3 there are 3 reasons that reducing the house-staff work hours may be beneficial: patient safety, house-staff health and quality of life, and quality of education. But what is the evidence that the 80-hour workweek results in improvement in any of these areas? There is certainly a widely held belief that better-rested physicians provide better care; however, this is balanced by the fact there is less patient continuity when caregivers change frequently. Each handoff increases the possibility of miscommunication errors. One study indicated that an effect of the 1989 New York regulations restricting work hours was a delay in ordering tests and increased rates of hospital complications.12 Another study suggested an increase in potentially preventable adverse events associated with resident physicians unfamiliar with the patients.13 Spending fewer hours with patients makes it difficult to observe and respond to changes in a patients condition. In a survey of trauma physicians in which shift work has been required to comply with the mandate, 54% of respondents thought that resident education had suffered, and 45% believed that patient care had worsened with the advent of the 80-hour work week.14 There are many similar reports such as these in other subspecialities.15,16
The loss of the number of hours worked by residents and fellows has shifted the burden to attending physicians. Attending physicians must spend more time gathering data, reviewing records, completing progress notes and discharges, arranging follow-up, etc—work previously performed by house staff. This has resulted in attending physicians spending more time tracking things down or reducing their patient load.17 Because this is simply a shift in the workload, there is little to support that the move has necessarily resulted in improving patient care.
In a recent observational study of Medicare patients, neither a reduction nor an increase in 30-day mortality rates was found in the first or second year after institution of the residents duty hour limits among either medical or surgical conditions.18 After surveying the literature, Fletcher and others,19 in fact, concluded that there are no convincing data that the reduction in work hours has improved patient safety.
It is even murky as to whether the fellows quality of life is better. In a study that evaluated residents sleep hours in the year after implementation of the work hour limitation, the mean nightly sleep duration increased only 22 minutes (6.1%), from 5.91 to 6.27 hours, while nightly sleep during extended work shifts decreased only 4.5%, from 2.69 to 2.57 hours.20
In the absence of any evidence that these mandates have improved the outcome of patient health or of fellow education, is the "grief an pain" in the process all for naught? If considered in the parlance of clinical trial design (something with which most cardiologists can relate), the interventions of duty hour limitation and focusing on core competencies represent only surrogate markers for the desired end point of improved patient outcome and a more competent cardiology fellow. Valid surrogate markers, however, must fully correlate with the desired outcome to capture the net effect of treatment.21 Multiple interventions in medicine that have targeted such surrogate end points have subsequently been found to have either a neutral or an adverse effect on the clinically meaningful end point when the appropriately powered and designed study was performed. These same principles of clinical trial design could be applied to ACGME interventions, but to date they have not. Analysis of meaningful end points is particularly urgent now because there is a serious discussion about reducing house-staff duty hours in the United States even further. The British Medical Association and the European Parliament and Council of Ministers already developed a European Working Time Directive that mandated a 56-hour workweek that began in August 2007 and a 48-hour workweek beginning August 2009.22,23 The impact of similar changes in the United States would be profound.
| So Why Have the ACGME Interventions Created Some Much Frustration When the Intentions Seem So Worthy? |
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Another major issue in dealing with the ACGME is its large size. Currently, there are 28 review committees and 8186 accredited residency and fellowship programs in 120 subspecialties. The total number of trainees under the ACGME umbrella is now well over 103 000. With its 174 general cardiology programs and 2300 general cardiology fellows, cardiology is only a single small subspecialty under the ACGMEs domain. Interventional cardiology and electrophysiology programs are even smaller segments, including <500 fellows. The total number of all cardiology fellows makes up only
2% of ACGME trainees. With such a large and diverse group for the ACGME to govern, there can be little room for appeals or requests for modifications to foster improvements that could be beneficial to any particular subspecialty.
Finally, others have noted that although the ACGME has spent years evaluating the quality of residency programs, its process of self-evaluation has not followed suit.3 Even though some have strongly advocated that the ACGME conduct a thorough internal review and submit to a peer review by an external commission, the ACGME has not done so,24 and why should it? It has little incentive to do so because it can impose its will on GME without such scrutiny.
| So Where Do We Go From Here? |
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The American Board of Internal Medicine (ABIM), as the certifying organization for the specialty of cardiovascular medicine, is also been an important player, and close partnership with the ABIM is critical. As part of the process of Maintenance of Certification for specialists in internal medicine, physicians are now required to perform a Practice Improvement Module. This practical module entails choosing a disease state (for the cardiologist, this includes conditions such as hypertension and preventive cardiology), surveying patients cared for by the physician, performing a chart review, and submitting the data to the ABIM. A report is generated and returned to the physician with quality improvement goals, and an improvement plan or process must be developed, implemented, and tested. Although a commendable goal, there is as yet no evidence that this is of value for either education or patient care.
In the current environment, there is little leeway for experimentation to test alternative approaches to training cardiology fellows by piloting programs designed for specific training opportunities. For instance, it seems unrealistic for programs designed to produce only outstanding clinical cardiologists to follow the precise training pathway as programs designed to train clinician-researchers and clinician-educators for careers in academic medicine. How much research training does the cardiology trainee who is interested in clinical practice really need, and how much (and of what quality) can even the very best clinically oriented programs provide? Similarly, if the focus of the training program is on developing academic faculty, should such centers not be allowed to experiment to determine whether some modification to better integrate research time into the training is acceptable as long as clinical competency is achieved? For instance, in our own training program, we requested modifying the training pathway to be 1 year of clinical training, followed by 2 years of research, and then a final year of clinical training in an effort to improve the opportunities for such graduates to obtain an academic position. This concept was rejected by the ACGME because it violated the 2 clinical years within a 3-year period rule with no consideration for using the concept as a pilot project to determine its validity. There is simply no flexibility or room for innovation in the current ACGME structure.
| A Few Suggestions |
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| Conclusions |
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| Acknowledgments |
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Disclosures
None.
| References |
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19. Fletcher KE, Davis SQ, Underwood W, Mangrulkar RS, McMahon LF Jr, Saint S. Systematic review: effects of resident work hours on patient safety. Ann Intern Med. 2004; 141: 851–857.
20. Landrigan CP, Barger LK, Cade BE, Ayas NT, Czeisler CA. Interns compliance with accreditation council for graduate medical education work-hour limits. JAMA. 2006; 296: 1063–1070.
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| Footnotes |
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This article is Part II of a 2-part article. Part I appears on page 525.
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