Christine Laine, MD, MPH, Editor in Chief; Darren B. Taichman, MD, PhD, Executive Deputy Editor; Cynthia Mulrow, MD, MSc, Senior Deputy Editor
Laine C., Taichman D., Mulrow C.; Trustworthy Clinical Guidelines. Ann Intern Med. 2011;154:774-775. doi: 10.7326/0003-4819-154-11-201106070-00011
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Published: Ann Intern Med. 2011;154(11):774-775.
A dizzying array of diagnostic and therapeutic options, along with the wide variation in evidence to support them, challenges the provision of rational medical care. Clinical guidelines should bring order to this chaos. Yet, the development of thousands of clinical practice guidelines by hundreds of groups in dozens of countries creates its own tangle for clinicians to unravel. Guidelines could very well become part of the very problem they aim to solve. How can busy clinicians struggling to do what is best for their patients identify guidelines that they can trust?
Common concerns about guidelines relate to the quality of the evidence base that supports them (1), a lack of clarity about the degree to which opinion rather than evidence shapes the recommendations (2), conflicts of interest among guideline developers (3, 4), inadequate recognition of the heterogeneity of patient characteristics and preferences (5), and the feasibility of implementation (6). Such concerns and a charge included in the Medicare Improvements for Patients and Providers Act of 2008 prompted the Institute of Medicine (IOM) to release a set of rigorous standards for developing high-quality clinical practice guidelines (7). Table 1 highlights the characteristics that the IOM believes define trustworthy guidelines. Some of the proposed standards address issues long recognized as important: the supremacy of evidence over opinion, the importance of disclosure and management of potential conflicts of interest among guideline developers, and the requirement that guideline reports include a clear description of the development process. Other proposed standards address processes that few guideline groups have yet adopted, such as the inclusion of patient representatives in the development process, an open public comment period, and a clear plan for guideline updates. All in all, the IOM sets a high bar, and strict application of the standards would classify many, if not most, clinical guidelines as untrustworthy.
Does this mean that clinicians, patients, and others should abandon guidelines as a way to define high-quality care? We think not. High-quality clinical guidelines can simplify medical decision making and improve care by identifying current practices that maximize benefit and minimize harm. They specify areas in which evidence is lacking and help set priorities for future research. Instead of an excuse to abandon guidelines, we see the IOM report as a powerful tool for guideline assessment that could help clinicians and others identify the best guidelines. Furthermore, by setting the bar very high, the IOM report promises to stimulate the extinction of poor-quality guideline groups and improvement in the quality of available guidelines.
Over the past decade, Annals of Internal Medicine has published many guidelines developed by the U.S. Preventive Services Task Force (USPSTF) and by the American College of Physicians (ACP) and considers the work of these groups to be of very high quality. Yet, even these exemplary groups have room for improvement when judged by the IOM criteria (8, 9). For example, the USPSTF only recently implemented a process for prerelease public comment, in response to controversy over the November 2009 recommendations on breast cancer screening (www.uspreventiveservicestaskforce.org). Currently, the Clinical Guideline Committee of the ACP is developing processes to bolster its methods for patient representation and guideline updating. Accordingly, we look forward to publishing clinical guidelines of even higher quality from these groups.
We also encourage other developers of high-quality guidelines that are highly relevant to internal medicine to consider Annals as a venue for publication of their main reports. Our rigorous and efficient review process helps guideline groups optimize the quality of their reports before publication. Guidelines published in Annals are freely available from the day of publication at www.annals.org, enabling them to reach a broad audience that extends well beyond the 140 000 physicians who are ACP members and thousands of other health care providers who access the journal through individual and institutional subscriptions. Because we are aware of the intense public interest in practice guidelines, we prepare lay-language summaries of guidelines that are freely available at www.annals.org to assist in the dissemination of this important material. Each year, guidelines published in Annals are commonly covered by the lay and professional media. Finally, we strive to enable constructive and lively discussion of guidelines at www.annals.org after their release (10).
The guidelines that we publish receive wide attention from our readership. We believe our readers also value learning about high-quality guidelines that are published elsewhere, and we know that all busy people appreciate a good summary of something important that might be longer than they have time to read. Thus, in addition to considering primary reports of new guidelines, such as those we publish from the USPSTF and ACP, we seek to publish thoughtful synopses of guidelines initially released in other venues but whose topics are highly relevant to the practice of internal medicine and its subspecialties. As the first example of this new venture, this issue contains a synopsis of the guideline on prevention of delirium from the United Kingdom's National Institute for Health and Clinical Effectiveness (NICE) (11). Accompanying descriptions of NICE's methods for guideline development (12, 13) detail a process that comes close to meeting the IOM's rigorous definition of trustworthy. We invite other groups whose guidelines meet the criteria listed in Table 2 to submit their synopses.
We believe that current, high-quality practice guidelines promote excellence in care, and we are glad to provide a venue for their wide dissemination and discussion. We urge readers to gain familiarity with the IOM standards and consider them as they use guidelines to navigate the maze of available clinical choices.
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University of Ghent, General Practice
July 5, 2011
Cultural Differences in Clinical Guidelines
Dear editor, The editorial of June 7th about trustworthy clinical guidelines rightly mentions possible concerns about guidelines but other important concerns may remain and may relate to (cultural?) differences in interpretation of the available studies.
In an international comparison of acute sore throat guidelines for example (1), six national guidelines recommend diagnostic testing and prescribing antibiotics to prevent acute rheumatic fever if a streptococcal pharyngitis is suspected, whereas four other national guidelines discourage diagnostic testing and reserve antibiotics for high- risk patients only. Hereby, each guideline may -according to the interpretation and selection of the evidence and to the IOM criteria - pretend a sufficient level of evidence and strength of recommendation.
How to unravel this tangle and trust clinical guidelines?
Guidelines deserve a bibliographic analysis with a cited evidence score, for example with number of cited intervention studies (meta- analyses) in a single guideline) / maximum possible number of unique intervention studies (meta-analyses) cited according to the publication date of the guideline (2). Evidence citation scores will allow a better assessment and comparison of guidelines and will untangle for example cultural differences (3).
Another point of discussion is how to deal with the proposal of authors to expand guideline recommendations in specific conditions, in an era in which evidence is lacking (4, 5).
1. Matthys J, De Meyere M, van Driel ML, De Sutter A. Differences among international pharyngitis guidelines: not just academic. Ann Fam Med. 2007;5:436-43.
2. Van de Velde S, Heselmans A, Donceel P, Vandekerckhove P, Ramaekers D, Aertgeerts B. Rigour of development does not AGREE with recommendations in practice guidelines on the use of ice for acute ankle sprains. BMJ Qual Saf 2011;bmjqs.2010.045435.
3.Christiaens T, De Backer D, Burgers J, Baerheim A. . Guidelines, evidence, and cultural factors. Scand J Prim Health Care. 2004;22:141-5.
4. Centor RM. Expand the pharyngitis paradigm for adolescents and young adults. Ann Intern Med. 2009;151:812-5.
5. De Meyere M, Matthys J. Should we expand the pharyngitis paradigm for adolescents and young adults? Ann Intern Med. 2010;152:477-8.
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