Below is an editorial that appeared in the February 25, 2009 Journal of the American Medical
Association that mentions topics that are often discussed in the Drug Information classes: "...
too many current guidelines have become marketing and opinion-based pieces ..."; and that
guidelines are developed from the lowest level of evidence "expert opinion." Expert
opinion has its roots in clinical experience.
This editorial accompanied research (JAMA.
2009; 301(8):831-841) that critically evaluated the scientific support for the current American
College of Cardiology/American Heart Association (ACC/AHA) clinical practice guideline that
"Recommendations issued in current ACC/AHA clinical practice guidelines are
largely developed from lower levels of evidence or expert opinion. The proportion of recommendations
for which there is no conclusive evidence is also growing. These findings highlight the need to
improve the process of writing guidelines and to expand the evidence base from which clinical
practice guidelines are derived."
When faced with a clinical practice guideline refer to
the MAARIE framework as part of the evaluation of the validity of the guideline.
Reassessment of Clinical Practice Guidelines
Go Gently Into That Good Night
Terrence M. Shaneyfelt, MD, MPH; Robert M. Centor, MD
1990, the Institute of Medicine proposed guideline development to reduce inappropriate health care
variation by assisting patient and practitioner decisions.1 Unfortunately, too many current
guidelines have become marketing and opinion-based pieces, delivering directive rather than
Current use of the term guideline has strayed far from the original
intent of the Institute of Medicine. Most current articles called "guidelines" are
actually expert consensus reports. It is not surprising, then, that the article by Tricoci et al2 in
this issue of JAMA demonstrates that revisions of the American College of Cardiology (ACC)/American
Heart Association (AHA) guidelines have shifted to more class II recommendations (conflicting
evidence and/or divergence of opinion about the usefulness/efficacy of a procedure or treatment) and
that 48% of the time, these recommendations are based on the lowest level of evidence (level C:
expert opinion, case studies, or standards of care). This trend is especially disconcerting given
the quantity of cardiovascular scientific literature published during the last decade.
overreliance on expert opinion in guidelines is problematic. All guideline committees begin with
implicit biases and values, which affects the recommendations they make.3 However, bias may occur
subconsciously and, therefore, go unrecognized. Converting data into recommendations requires
subjective judgments; the value structure of the panel members molds those judgments.4 Guideline
consumers could adjust for these biases if guideline panels made their values and goals explicit,
but usually they remain opaque.5 The most widely recognized bias is financial. Guidelines often have
become marketing tools for device and pharmaceutical manufacturers. While the ACC and AHA receive no
industry funding for guideline development, they do receive industry support to disseminate
guideline products such as pocket guides. Financial ties between guideline panel members and
industry are common. "Experts" on guideline panels are more likely to receive industry
funding for research, consulting fees, and speakers' honoraria. In 1 study of 44 guidelines, 87% of
the guideline authors had some form of industry tie.6
Other biases are also important. The
specialty composition of a guideline panel likely influences guideline development. Specialty
societies can use guidelines to enlarge that specialty's area of expertise in a competitive medical
marketplace. Federal guideline committees may focus on limiting costs; committees influenced by
industry are more likely to shape recommendations to accord with industry needs.
have other limitations. Guidelines are often too narrowly focused on single diseases and are not
patient focused. Patients seldom have single diseases, and few if any guidelines help clinicians in
managing complexity.7 Paradoxically, guidelines are also often too comprehensive, covering every
possible intervention that could be appropriate for a patient with that single disease. Tricoci et
al2 found that in ACC/AHA guidelines with at least 1 revision, the number of recommendations
increased 48% from the first guideline to the most recent version. If there is a main message in
such guidelines, it is likely to be lost in the minutiae. Guidelines are not patient-specific enough
to be useful and rarely allow for individualization of care. Most guidelines have a
one-size-fits-all mentality and do not build flexibility or contextualization into the
recommendations.5, 7 There are simply too many guidelines, often on the same topic. For instance,
clinicians really do not need 10 different adult pharyngitis guidelines.8 Moreover, guidelines are
often out of date. The evidence base used to create guidelines changes quickly. Most guidelines
become outdated after 5 years, and most guideline developers lack formal procedures for updating
their guidelines.9-10 The ACC/AHA guidelines are periodically updated, with updates taking a mean of
4.6 to 8.2 years until publication.2
As a result, many clinicians do not use guidelines. An
even greater concern, however, is that some of these consensus statements are being turned into
performance measures and other tools to critique the quality of physician care. This potential
problem could be minimized if performance measures were derived from high-quality guidelines based
on the highest level of evidence and applied to patients with a single disease requiring little
clinical judgment and no attention to patient preferences. Using multiple single disease-focused
quality indicators to judge the quality of care provided to older patients with multiple
comorbidities creates another level of difficulty.7 These patients require collaborative efforts to
balance each patient's overall health status with the burdens, risks, and benefits of complex care,
something single disease guidelines and their resultant quality indicators do not address. If
guidelines continue to exist, they need to undergo major changes. Recently, Sniderman and Furberg11
called for reforming the guideline development process. Their suggestions could be strengthened
further by not only creating codes to "govern conflict of interest," as disclosure and
governance alone will not ensure unbiased recommendations, but also by guideline panel membership
limiting (if not excluding) those with financial or other potential conflicts of interest or at
least being balanced by members having no conflicts of interest. Only when likely biases of industry
and specialty societies have been either removed or overcome by countervailing interests can
impartial recommendations be achieved.
The time has come for guideline development to again
be centralized, for example under the guidance of the Agency for Healthcare Research and Quality or
a group similar to the US Preventive Services Task Force. Such centralization should help reduce
bias and redundancy and better guide the research agenda. The US Department of Health and Human
Services seems best suited to fund guideline endeavors.
In addition, guideline development
needs to be prioritized. Guidelines are not necessary for every disease but are needed for diseases
having significant practice variability and for which a valid evidence base can guide
recommendations. Within a guideline document, individual recommendations also need to be
prioritized. For instance, recommending that a symptomatic heart failure patient with decreased
ejection fraction should receive an angiotensin-converting enzyme inhibitor is clearly more
important than repeatedly documenting left ventricular systolic function.12
guidelines need flexibility. Clinical guidelines are supposed to be guides, not rules, and one size
certainly does not fit all patients. Recommendations should vary based on patient comorbidities, the
health care setting, and patient values and preferences. If flexibility is to be taken seriously,
the nearly automatic translation of guidelines into performance measures would require renewed
These recommendations are not new but need to be heeded. However, it seems
unlikely that substantial change will occur because many guideline developers seem set in their
ways. If all that can be produced are biased, minimally applicable consensus statements, perhaps
guidelines should be avoided completely. Unless there is evidence of appropriate changes in the
guideline process, clinicians and policy makers must reject calls for adherence to guidelines.
Physicians would be better off making clinical decisions based on valid primary data.
Corresponding Author: Terrence M. Shaneyfelt, MD, MPH, Veterans Affairs Medical
Center, 700 S 19th St, Birmingham, AL 35233 (email@example.com).
Additional Contributions: We thank Thomas Huddle, MD, PhD, Division of General
Internal Medicine, and Stefan Kertesz, MD, MPH, Division of Preventive Medicine, University of
Alabama School of Medicine, for their valuable comments on previous drafts of the manuscript.
Neither individual received compensation for their contributions.
Editorials represent the
opinions of the authors and JAMA and not those of the American Medical Association. Author
Affiliations: Veterans Affairs Medical Center (Dr Shaneyfelt) and Department of Medicine, University
of Alabama School of Medicine (Drs Shaneyfelt and Centor), Birmingham; Huntsville Regional Medical
Campus, Huntsville, Alabama (Dr Centor).
1. Committee to Advise the Public
Health Service on Clinical Practice Guidelines, Institute of Medicine. Clinical Practice Guidelines:
Directions of a New Program. Field MJ, Lohr KN, eds. Washington, DC: National Academy Press;
2. Tricoci P, Allen JM, Kramer JM; et al. Scientific evidence underlying the ACC/AHA
clinical practice guidelines. JAMA. 2009;301(8):831-841. FREE FULL
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2006;175(9):1033, 1035. PUBMED
4. Shrier I, Boivin JF, Platt RW; et al. The interpretation of
systematic reviews with meta-analysis: an objective or subjective process? BMC Med Inform Dec
Making. 2008;8:19. FULL TEXT | PUBMED
5. Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are
guidelines following guidelines? the methodological quality of clinical practice guidelines
published in the peer reviewed medical literature. JAMA. 1999;281(20):1900-1905. FREE FULL
6. Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical
practice guidelines and the pharmaceutical industry. JAMA. 2002;287(5):612-617. FREE FULL
7. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines
and quality of care for older patients with multiple comorbid diseases: implications of pay for
performance. JAMA. 2005;294(6):716-724. FREE FULL
8. Matthys J, De Meyere M, van Driel ML, De Sutter A. Differences among
international pharyngitis guidelines: not just academic. Ann Fam Med. 2007;5(5):436-443. FREE FULL TEXT
9. Shekelle PG, Ortiz E, Rhodes S; et al. Validity of the Agency for Healthcare Research and
Quality clinical practice guidelines: how quickly do guidelines become outdated? JAMA.
2001;286(12):1461-1467. FREE FULL TEXT
10. Burgers JS, Grol R, Klazinga NS, Makela M, Zaat J,
AGREE Collaboration. Towards evidence-based clinical practice: an international survey of 18
clinical guideline programs. Int J Qual Health Care. 2003;15(1):31-45. FREE FULL
11. Sniderman AD, Furberg CD. Why guideline-making requires reform. JAMA.
2009;301(4):429-431. FREE FULL TEXT
12. Fonarow GC, Abraham WT, Albert NM; et al, OPTIMIZE-HF
Investigators and Hospitals. Association between performance measures and clinical outcomes for
patients hospitalized with heart failure. JAMA. 2007;297(1):61-70.
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