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Rigorous review goes into ACP's clinical guidelines

From the November/December ACP Observer, copyright © 2007 by the American College of Physicians.

The ACP began developing clinical practice guidelines in 1981. Originally this work was funded by a grant from Blue Cross and Blue Shield to help evaluate diagnostic tests and new technologies. I remember these early days, because I served then as a representative from the American Society of Hematology for the ACP's new Clinical Efficacy Assessment Project (CEAP). ACP was a pioneer in developing the process for rigorously evaluating the evidence for the effectiveness of clinical practices. This initiative of the College and a few other groups led to what we know now as "evidence-based medicine."

Clinical guidelines have now become commonplace and many groups develop and promulgate them. A check of Google returns more than 10 million listings, PubMed lists 52,270 articles under the heading "clinical guidelines" and the Web site, maintained by the Agency for Healthcare Research and Quality (AHRQ), lists several hundred guidelines from various medical organizations. There is obviously much redundancy, some conflicts and some out-of-date guidelines in all this information. For organizations and publishers, it is also hard to keep a Web site for clinical guidelines current.

ACP guidelines are based on a careful, systematic review of the medical literature. ACP staff, outside experts and consultants, and a committee composed of ACP Members, Governors and Regents are involved in the review process. The published reports are scored using standardized techniques. In the evaluation, greater weight is given to the results of randomized, controlled trials than to cohort and case-controlled studies. Although in practice we are often influenced by case reports, our own experience, colleagues' advice and anecdotes, this kind of information is not very useful in guideline development.

The literature review leads to background and evidence reports; these reports are now frequently published in Annals of Internal Medicine together with the ACP guidelines. ACP guidelines are a series of succinct statements with explanations, summarizing key clinical issues in the evidence report. Great attention is given to every word of the guideline, so when it is published, you can be sure it has been reviewed and critiqued over and over again. Before being published, guidelines produced by the ACP's Clinical Efficacy Assessment Subcommittee (CEAS) are reviewed by the Education Committee and the Board of Regents as well as by Annals' editors and reviewers.

During my tenure on the Board of Governors, I chaired the CEAS and really enjoyed this work. I found it stimulating to be involved in selecting topics for ACP guideline development, trying to recognize what is new and where there are significant changes and controversies. I also found that developing and reviewing guidelines is a great way to review medicine, especially the part of medicine that really counts—doing the right tests and prescribing the right treatments—in the clinic and at the bedside.

We now have a broad array of options for testing and treating our patients. The costs associated with many of these decisions is so high that it is imperative that we organize and stratify what to do first, second and third, based on current evidence, not what we might have learned years ago. The guideline development process is also important in identifying the limits and uncertainties of our knowledge. ACP guidelines, as well as those from other organizations, often point out specific needs for additional clinical research.

In 2005 the College conducted a member survey to evaluate our guideline development process. Almost one quarter of the respondents indicated that they are required in some way to use practice guidelines and almost half indicated that their organization uses ACP guidelines. Almost all found ACP guidelines scientifically sound and helpful, but about one-third of the respondents indicated that the guidelines were difficult to understand, impractical or rigid. Time constraints and patients' willingness to follow the guidelines were regarded as the chief obstacles to their implementation. The survey also brought out the problems we all face in dealing with reimbursement from insurance companies and the government for our services and the varying rules about what they will and will not cover.

In thinking about clinical guidelines, it is important to keep in mind that they are just guidelines. They deal chiefly with the part of medicine that is common and has been studied most intensely. Guidelines seldom deal with the care of patients with multiple diseases of varying stage and severity, or with rare diseases. They often do not take into account the local resources of the clinic, hospital or community or the ethnicity and diversity of our patients. Nevertheless, I believe that guidelines, and particularly the ACP guidelines, are extremely helpful. They provide a structured way to think about what we do, what we should do and how we communicate with our patients.

I hope that you find the Clinical Efficacy Assessment Project and ACP guidelines helpful in your practice. We welcome your comments.

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