Reliable Clinical Guidelines—Great Idea, Not-Such-A-Great Reality
Although clinical guideline recommendations about managing a given condition may differ, guidelines are, in general, considered to be important sources for individual clinical decision-making, protocol development, order sets, performance measures and insurance coverage. The Institute of Medicine [IOM] has created important recommendations that guideline developers should pay attention to—
- Management of conflict of interest;
- Guideline development group composition;
- How the evidence review is used to inform clinical recommendations;
- Establishing evidence foundations for making strength of recommendation ratings;
- Clear articulation of recommendations;
- External review; and,
Investigators recently evaluated 114 randomly chosen guidelines against a selection from the IOM standards and found poor adherence [Kung 12]. The group found that the overall median number of IOM standards satisfied was only 8 out of 18 (44.4%) of those standards. They also found that subspecialty societies tended to satisfy fewer IOM methodological standards. This study shows that there has been no change in guideline quality over the past decade and a half when an earlier study found similar results [Shaneyfeld 99]. This finding, of course, is likely to have the effect of leaving end-users uncertain as to how to best incorporate clinical guidelines into clinical practice and care improvements. Further, Kung’s study found that few guidelines groups included information scientists (individuals skilled in critical appraisal of the evidence to determine the reliability of the results) and even fewer included patients or patient representatives.
An editorialist suggests that currently there are 5 things we need [Ransohoff]. We need:
1. An agreed-upon transparent, trustworthy process for developing ways to evaluate clinical guidelines and their recommendations.
2. A reliable method to express the degree of adherence to each IOM or other agreed-upon standard and a method for creating a composite measure of adherence.
From these two steps, we must create a “total trustworthiness score” which reflects adherence to all standards.
3. To accept that our current processes of developing trustworthy measures is a work in progress. Therefore, stakeholders must actively participate in accomplishing these 5 tasks.
4. To identify an institutional home that can sustain the process of developing measures of trustworthiness.
5. To develop a marketplace for trustworthy guidelines. Ratings should be displayed alongside each recommendation.
At this time, we have to agree with Shaneyfeld who wrote an accompanying commentary to Kung’s study [Shaneyfeld 12]:
What will the next decade of guideline development be like? I am not optimistic that much will improve. No one seems interested in curtailing the out-of-control guideline industry. Guideline developers seem set in their ways. I agree with the IOM that the Agency for Healthcare Research and Quality (AHRQ) should require guidelines to indicate their adherence to development standards. I think a necessary next step is for the AHRQ to certify guidelines that meet these standards and allow only certified guidelines to be published in the National Guidelines Clearinghouse. Currently, readers cannot rely on the fact that a guideline is published in the National Guidelines Clearinghouse as evidence of its trustworthiness, as demonstrated by Kung et al. I hope efforts by the Guidelines International Network are successful, but until then, in guidelines we cannot trust.
1. IOM: Graham R, Mancher M, Wolman DM, et al; Committee on Standards for Developing Trustworthy Clinical Practice Guidelines; Board on Health Care Services. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011 http://www.nap.edu/catalog.php?record_id=13058
2. Kung J, Miller RR, Mackowiak PA. Failure of Clinical Practice Guidelines to Meet Institute of Medicine Standards: Two More Decades of Little, If Any, Progress. Arch Intern Med. 2012 Oct 22:1-6. doi: 10.1001/2013.jamainternmed.56. [Epub ahead of print] PubMed PMID: 23089902.
3. Ransohoff DF, Pignone M, Sox HC. How to decide whether a clinical practice guideline is trustworthy. JAMA. 2013 Jan 9;309(2):139-40. doi: 10.1001/jama.2012.156703. PubMed PMID: 23299601.
4. Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA. 1999 May 26;281(20):1900-5. PubMed PMID: 10349893.
5. Shaneyfelt T. In Guidelines We Cannot Trust: Comment on “Failure of Clinical Practice Guidelines to Meet Institute of Medicine Standards”. Arch Intern Med. 2012 Oct 22:1-2. doi: 10.1001/2013.jamainternmed.335. [Epub ahead of print] PubMed PMID: 23089851.