Author + information
- aEastern Virginia Medical School and Sentara Healthcare, Norfolk, Virginia
- bMount Sinai Medical Center, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. John E. Brush, Jr., Eastern Virginia Medical School and Sentara Healthcare, 844 Kempsville Road, Suite #204, Norfolk, Virginia 23502-3927.
- clinical decision making
- comparative effectiveness research
- Great Britain
- patient-centered care
- United States
In 1991, Dr. Gordon Guyatt coined the term evidence-based medicine to describe a new method for training internal medicine residents at McMaster University (1). In a brief editorial, he placed a label on what would become an important international movement. At that time, a growing group of clinical epidemiologists in North America and the United Kingdom was developing a new way of thinking that demanded a more critical appraisal of medical care (2). Tradition, anecdote, pathophysiological considerations, and the authority of textbooks and senior physicians were no longer sufficient. Assumptions were challenged, and recommendations came to require testing and validation through outcomes-oriented clinical research.
The most prominent proponent of this paradigm shift was the late Dr. David Sackett. With clear thinking and determination, Dr. Sackett led an international community that invented research methods, created educational venues, and developed an international infrastructure to support this new model of medical care. The evidence-based medicine movement proposed a hierarchy of evidence, on the basis of the trustworthiness of research methods, with the randomized controlled trial and meta-analysis at the top of the heap. The movement placed importance on systematic reviews of clinical trials, and bolstered the use of clinical practice guidelines in the United States and Europe.
This new way of thinking created enthusiasm, but it also created a backlash. Some people argued that evidence-based medicine was “cookbook medicine” that neglected the “art of medicine.” They argued that evidence-based medicine was reductionist, ignoring mechanistic reasoning, tacit knowledge, and clinical intuition. Critics warned that insurers, policy makers, and regulators would highjack evidence-based medicine to push vested interests that would conflict with the best interest of patients.
In 1996, Sackett et al. (3) reiterated the definition of evidence-based medicine as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” According to Dr. Sackett, “good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough” (3). He and others remained self-critical, acknowledging that there are limitations to evidence-based medicine and that the field would remain a work in progress (3,4).
To those of us who grew up in this era, evidence-based medicine seems well established, yet the controversy lingers. In this issue of the Journal, Sheridan and Julian (5) present a commentary titled, “Achievements and Limitations of Evidence-Based Medicine.” Their title suggests balance, but their commentary is more critical than supportive of evidence-based medicine, and the “bone” they pick is more about the implementation of evidence-based medicine than the evidence-based medicine model itself. Whether their perspective on the implementation of evidence-based medicine in the United Kingdom represents the general view of U.K. physicians is hard to judge from this side of the pond, but they present a strongly worded piece about the effect of evidence-based medicine in the United Kingdom. They seem concerned about the size and reach of the Cochrane Collaboration, and they take issue with several decisions made by regulators in the United Kingdom that were purportedly evidence-based. They list a number of grievances and examples of how evidence-based medicine had untoward effects on clinical practice in the United Kingdom. In our view, one must be cautious when reading their commentary to avoid throwing the baby out with the bathwater.
Sheridan and Julian (5) state that the movement, “claimed to have initiated a ‘new paradigm’ of medical practice.” They also say that, “coining the phrase evidence-based medicine and claiming to have identified a new paradigm of medical practice were brilliant rhetorical devices which successfully captured the attention of the general and medical media” (5). In our view, demoting the status of evidence-based medicine to a “rhetorical device” is unwarranted. The contention that “much of what the [evidence-based medicine] movement originally proposed has long been discounted” is unsubstantiated and contradicted by other statements in their commentary. In fact, they acknowledge that, “the introduction of randomized controlled clinical trials was 1 of the greatest achievements of medicine during the last century” and “clinical guidelines are intimately connected to [evidence-based medicine] in that they provide a means to disseminate what the [evidence-based medicine] movement advocates” (5).
Sheridan and Julian (5) list a number of limitations of evidence-based medicine that have been discussed by other commentators (4). The limitations of randomized controlled trials and meta-analyses were discussed in an excellent series published recently in the Journal (6). We agree with their observations that evidence-based medicine does not cover every clinical question and that clinical trials do not provide evidence that extends beyond the duration of a particular trial. It is also true that most randomized controlled trials do not address patients with multiple coexisting diseases, and it is well known that there is nothing sacrosanct about a p value cutpoint of 0.05.
One accomplishment of the evidence-based medicine movement was to reinforce conventional wisdom in the medical world. A p value cutpoint of 0.05 is arbitrary, but by convention we have decided that a 1 in 20 chance of arriving at a reported trial result is the point at which one should consider rejecting the null hypothesis. Clinicians who are steeped in evidence-based medicine know that a large trial can have a statistically significant p value, but a small absolute treatment effect and minimal clinical importance. Indeed, the emphasis on evidence-based medicine in the published medical data and at national and international meetings has educated practicing physicians and has had a democratizing effect on medical reasoning. Knowledge of evidence-based medicine has enabled clinicians to independently evaluate published reports to make treatment decisions that are sensitive to the context, values, and needs of individual patients.
The evidence-based medicine movement has also bolstered the effect of clinical practice guidelines. Clinical practice guidelines provide a way to effectively and efficiently help the practicing clinician keep up-to-date. It is well known that their recommendations are intended as guidelines and not rules. Every American College of Cardiology (ACC)/American Heart Association (AHA) guideline begins with a preamble that explicitly states that they are not meant to replace clinical judgment. In the United States, as well as in Europe, clinical guidelines have spawned a quality of care imperative that has led to substantial improvements in patient outcomes. Guidelines have led to the development of performance measures, decision-support tools, standardized order sets, and national quality improvement initiatives. There are other spinoffs of evidence-based medicine, including comparative effectiveness research, personalized medicine, precision medicine, shared-decision-making, patient-centered care, open science, and a renewed emphasis on professionalism, to name just a few.
From an American perspective, the implementation of evidence-based medicine has been robust, but not without controversy. Two recent Institute of Medicine reports have articulated a set of principles for developing guidelines and systematic reviews (7,8). The ACC and the AHA continue to produce trustworthy guidelines that meet the Institute of Medicine’s high standards (9). The United States Preventive Services Task Force is an independent panel of experts that continues to provide responsible (and sometimes controversial) guidance to the public regarding screening and prevention. In 2013, the National Heart, Lung, and Blood Institute announced that it was turning its guideline-writing agenda over to professional societies and other organizations (10), and that transition is proceeding in deliberate fashion. The 2013 cardiovascular disease prevention guidelines, initiated by the National Heart, Lung, and Blood Institute and published by the ACC and AHA, created a great deal of controversy, but the controversy was ultimately helpful in identifying important issues and drawing a clear line between current evidence and lingering clinical uncertainty (11).
In the United States, there is no central authority for evidence-based medicine, perhaps reflected in the limited budget assigned to the Agency for Healthcare Research and Quality and the National Institutes of Health, but there is no indication that evidence-based medicine is drawing funding away from basic science research. The largest and most powerful regulator in the United States is the Food and Drug Administration, an organization that uses evidence-based medicine to make important decisions about drugs and devices. The recent appointment of Dr. Robert M. Califf as commissioner of the Food and Drug Administration is a particular cause for optimism, given his longstanding commitment to integrating quality and evidence into the development of new therapies (12).
Still, challenges remain. To fully implement evidence-based medicine, practicing clinicians need a better understanding of how to apply population statistics to individual patients. The evidence-based medicine movement provided simple numerical tools, such as numbers needed to treat and likelihood ratios, to help clinicians in this process. For clinicians to become fully proficient in their application, however, medical education must place a greater emphasis on clinical reasoning and clinicians need to use these methods deliberately in practice (13). The evidence-based medicine movement produced the Rational Clinical Examination series to help clinicians reach diagnoses with greater scientific rigor, yet the greatest effect of the evidence-based medicine movement has been in the area of therapeutic decision making (14). There is a need to emphasize an evidence-based approach to diagnostic decision-making and to support this through education as well as in research (15). As practicing physicians gain more confidence in their reasoning skills, they should be better equipped to use evidence-based medicine to engage patients more effectively in shared decision making.
Leaders of the evidence-based medicine movement and researchers should continue diligent efforts to ensure that research is designed, funded, and conducted appropriately. The ACC/AHA Task Force on Clinical Practice Guidelines and the writing committees it commissions should continue to apply high standards to ensure that recommendations are trustworthy and informative. Practitioners should pursue continuing education and develop habits that combine clinical expertise with the best available evidence to optimize care for each and every patient. Evidence-based medicine is here to stay, and it is up to academicians, policy makers, professional societies, practicing physicians, students, trainees, and patients to work constructively toward ensuring that it reaches its fullest potential.
↵∗ Counterpoints published in the Journal of the American College of Cardiology reflect the views of the authors and do not necessarily represent the views of JACC or the American College of Cardiology.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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