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
Reassessment of Clinical Practice Guidelines
Go Gently Into That
Terrence M. Shaneyfelt, MD, MPH; Robert M. Centor, MD
In 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 assistive statements.
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.
The 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
Guidelines 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.
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
Finally, 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 attention.
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; 1990.
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
3. Detsky AS. Sources of bias for authors of clinical practice guidelines. CMAJ.
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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