Eliseo Guallar, MD, DrPH; Christine Laine, MD, MPH, Editor in Chief
This article was published online first at www.annals.org on 28 January 2014.
Acknowledgment: The authors thank Jaya Rao, MD, MHS; Sankey Williams, MD; Cynthia Mulrow, MD, MSc; Darren Taichman, MD, PhD; Catharine Stack, PhD, MS; and Deborah Cotton, MD, MPH, for their critical review of drafts of the manuscript.
Potential Conflicts of Interest: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-0112.
Requests for Single Reprints: Eliseo Guallar, MD, DrPH, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, 2024 East Monument Street, Room 2-645, Baltimore, MD 21287; e-mail, email@example.com.
Current Author Addresses: Dr. Guallar: Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Medical Institutions, 2024 East Monument Street, Room 2-645, Baltimore, MD 21287.
Dr. Laine: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106-1572.
Guallar E., Laine C.; Controversy Over Clinical Guidelines: Listen to the Evidence, Not the Noise. Ann Intern Med. 2014;160:361-362. doi: 10.7326/M14-0112
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Published: Ann Intern Med. 2014;160(5):361-362.
On 19 November 2013, a New York Times editorial recommended that persons in good cardiovascular health ignore the recent cholesterol guidelines from the American College of Cardiology and the American Heart Association (ACC/AHA) (1, 2). Complicating matters, the arguments prompting this stance were detailed in an article unavailable that was when the editorial was published (3). The New York Times fueled a hotly burning debate, but this was only one of many controversies raging about guidelines in recent years, such as the U.S. Preventive Services Task Force (USPSTF) recommendations on screening for breast cancer (4) and prostate cancer (5). In fact, the new hypertension guidelines from the Eighth Joint National Committee are even criticized by members of the very panel that developed them (6). Other articles address the scientific aspects of the new cholesterol guidelines (7–9). Here, we explore why guidelines generate controversy and ways to avoid controversies that leave patients and clinicians perplexed and distrustful.
Attacks on guidelines raise several common criticisms. Critics may question the legitimacy of the guideline committee. When a primary care group, such as the USPSTF, issues a guideline, subspecialists often label the recommendations unsound because the panel did not include subspecialty experts. This criticism can be vicious when recommendations call for more parsimonious use of interventions from which subspecialists profit—consider radiologists’ discontent with the USPSTF mammography recommendations (10). Conversely, when subspecialists issue guidelines, generalists sometimes gripe about the lack of primary care perspective. When guidelines focus on trials, critics call for recommendations to consider observational data and clinical experience. The presence of conflicts of interest is another common source of controversy, with claims that recommendations are designed to fill the pockets of those who would profit from the interventions advocated. Finally, guidelines that recommend against a course of action are often condemned for rationing care. The general public and many clinicians believe that, by default, more health care is better health care. Thus, somebody is certain to be upset when guidelines recommend not doing something—even if not doing it represents high-value care.
Outrage can be particularly intense when a guideline recommends abandoning a common practice, such as the ACC/AHA recommendation to discontinue targeting specific cholesterol levels as treatment goals, the USPSTF recommendation against using prostate-specific antigen levels for prostate cancer screening, or the Eighth Joint National Committee recommendation to increase the target systolic blood pressure to 150 mm Hg in persons aged 60 years or older. Reversal of prior practice can confuse health professionals and the public, who then question the wisdom of guidelines that withhold care they consider standard.
Some debate about guidelines is expected. Guidelines address complex clinical decisions fraught with alternatives, exceptions, and uncertainties. Guideline developers must integrate multiple studies, some with methodological limitations and conflicting results. High-quality studies that test the intervention in all scenarios in which the guideline might be applied are rare. In addition, guidelines target broad populations, but clinicians must make decisions about individuals who often do not fit general profiles. Attempts to standardize practice in complex situations with imperfect information set the stage for controversy.
Reasonable and knowledgeable people will have different definitions for evidence sufficient to recommend a certain course of action. Generalizing clinical trial results to different settings involves a subjective component. For example, trialists have evaluated statins in many situations, including primary prevention in persons defined as high-risk on the basis of risk factors. The ACC/AHA cholesterol guidelines, however, were criticized because no trial used a risk score for selecting participants, even though the score incorporates factors used to define risk in prior trials.
Unfortunately, many guidelines do not present recommendations in terms of benefits, harms, and costs that should guide clinical decisions. Although trials provide critical data on efficacy, recommendations should rest not only on trial results but also on the evaluation of the benefits and harms of alternative decisions. Part of the controversy surrounding the ACC/AHA cholesterol guidelines relates to uncertainty about the number of people who will have to start (or stop) statin therapy under the new guidelines. Decision models can quantify the consequences of each decision and provide data that may help resolve or at least elucidate uncertainties. Technology will make it increasingly possible to incorporate patient-specific characteristics and preferences into decisions.
Although some controversies over guideline recommendations are intellectually justified by the complexity of the task and the limitations of available evidence, social and emotional factors often needlessly magnify controversies. The ACC/AHA cholesterol guidelines landed in a perfect storm created by the release of the documents a few days before a high-profile meeting and media stories that sensationalized disagreements among stakeholders. Releases of high-profile guidelines have become media events that are timed with major scientific meetings and publication in leading journals. Competition for media attention is fierce among professional organizations and other stakeholders. Guideline committee membership is limited, leaving many experts out of the process. The surge in media attention accompanying the release of a guideline gives those who were left out the opportunity to attract some of the limelight. In addition, the 24/7 news cycle and blogosphere provide limitless occasions to magnify disagreements and provoke adversarial debate with little attention to the nuances supporting each position. The mudslinging outcry that increasingly seems to accompany guidelines is damaging, creates the impression that health care professionals are clueless, and risks compromising evidence-based medicine.
What might help to avoid counterproductive controversy? To start, inclusion of multiple stakeholders during guideline development could limit postrelease criticism (or at least prepare guideline developers to proactively address critics). Such input can come from inclusion of various stakeholders on the guideline committee or via a public comment period, such as that implemented by the USPSTF in an effort to prevent the frenzy that followed its 2009 mammography recommendations. Second, guideline developers should aim to base their recommendations on formal evidence reviews that are subject to rigorous peer review and fully available for scrutiny before a guideline is finalized. Criticism of the ACC/AHA recommendations may have been mitigated if the report describing the risk model used to identify eligibility for cholesterol treatment been available for public scrutiny before the guideline was released. Third, when guidelines counter prior practice, educational materials clearly explaining the evidence supporting the changes should be made available to clinicians, patients, and the public. Finally, professional organizations should refrain from turning the release of new or updated guidelines into media events, and the media should refrain from turning the scientific debate that surrounds guidelines into stories of professional strife and disregard for patients. If the goal is high-value health care for all, we must quiet the noise that accompanies guidelines so that we can hear the evidence speak.
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Andrew Miller, MD
Lenox Hill Hospital, PGY-2, Internal Medicine
February 19, 2014
Guideline In Excelsis Deo!
The author’s statement: "Reversal of prior practice can confuse health professionals and the public, who then question the wisdom of guidelines that withhold care *they* consider standard." (emphasis added) was an interesting way to frame this issue.
Take a moment and consider whom the authors have defined as "they." I’ll note, it is not “health professionals and the public" who create the notion of a "standard of care." Rather, a "standard" is created and handed down to the public by people and groups like these authors. It is only when the former "standard" is ignominiously invalidated by those who sit perched atop their ivory tower when the wrongness of the 'old' way is suddenly ascribed entirely to the ignorance of the unwashed masses. The audacity of that sort of thinking always astounds me. It exemplifies in the clearest possible way how we might better describe theirs as an ivory tower of Babel.
The editorial suggests there’s no need for the “noise” of open debate. It implies that “evidence” from a RCT, meta-analysis, or systemic review is somehow sacrosanct. No matter of course that a debate may be about the irony of replacing a prior untested lipid guideline in part with a new scoring system that is itself entirely untested. A 7.5% on such an unreviewed system might be accurate or it might simply be a nice number between 5 and 10.
No need to debate with useless noise the settled science of “evidence.” No matter of course that the JNC 8 guideline, though speaking quite highly about the importance of "evidence based medicine," ultimately published 6 of its 11 guidelines with the rating of "expert opinion."
The editorial authors' concluding sentence sums up this entire debate quite well: "If the goal is high-value health care for all, we must quiet the noise that accompanies guidelines so that we can hear the evidence speak." If one’s “evidence” is so weak that its supporters fear it may be shattered merely by a modicum of open debate and public scrutiny then I say bring on the debate! For the sake of creating the highest value health care for all of our patients, may we all continue to make noise. Evidence doesn’t speak, people do.
Andrew Miller, MD
Healthcare Delivery and Policy, Prevention/Screening.
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