Article

Reassessment of clinical practice guidelines: go gently into that good night.

JAMA The Journal of the American Medical Association (Impact Factor: 29.98). 03/2009; 301(8):868-9. DOI: 10.1001/jama.2009.225
Source: PubMed
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    ABSTRACT: Clinical guidelines were initially written as physician education tools for application within individual idealized patient encounters. Though based on large studies, applying guidelines to populations was not originally intended. However, this notion has been naively adopted in the rush to generalize, measure, and regulate quality [1]. Since given the new definition by the Institute of Medicine (IOM) in 1990, clinical guidelines have increasingly become a familiar part of clinical practice. As currently defined by IOM, clinical guidelines are " systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. " [2]. Guidelines are widely considered evidence based, unbiased, and valid. High quality guidelines have the potential to promote the use of effective clinical services, minimize undesirable practice variation, and reduce the use of unnecessary services [3]. Unfortunately, current use of the term " guidelines " has strayed away from the original intent of the IOM. Most so called " guidelines " publications are actually expert consensus reports [4]. There have been many concerns expressed, including limitations in the scientific evidence on which the guidelines relied, a lack of transparency of the guideline development groups' methodologies, and conflict of interest among guideline development group members and funders, as well as questions regarding how to reconcile conflicting guidelines [5]. Very often, we see bias in the development of guidelines , involving the reviewed research, misrepresentation of the data, or failure to assess the quality of the evidence supporting the recommendations. Inadequate or weak evidence may lead to conclusions based on value judgments, organizational preferences, or opinion. Specialty and subspecialty societies can use guidelines to enlarge their area of expertise in a competitive medical field. Federal guideline agencies usually focus on cost saving approaches, while committees influenced by industry are more likely to shape recommendations to accord with industry needs [6]. Also, the validity of systematic reviews and meta-analyses may also be negatively affected by bias. For example, several practice guidelines on long-term opioid therapy for chronic pain were published between 2008 and 2011. Although each guideline was based on analysis of essentially the same body of published research, the guideline conclusions differed significantly [6]. It reached the point that any group of individuals could designate itself a guideline group to come up with guidelines on some disease/condition; and different guideline groups could review the same disease/condition and reach different conclusions [7].
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    ABSTRACT: Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making. Expected final online publication date for the Annual Review of Pharmacology and Toxicology Volume 55 is January 06, 2015. Please see http://www.annualreviews.org/catalog/pubdates.aspx for revised estimates.
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