oped, they have the power to translate the complexity of scientific research findings into recommendations for clinical practice and potentially enhance healthcare quality and outcomes. However, the current state of CPG development has yet to meet this potential.

CPG DEVELOPMENT CHALLENGES

Clinical practice guidelines are ubiquitous in our healthcare system. The Guidelines International Network database currently lists more than 3,700 guidelines from 39 countries. Its U.S. counterpart, the National Guideline Clearinghouse (NGC), accepted 722 guidelines to its database in 2008 alone, so that its total collection is nearly 2,700. CPG developers and users are characterized by varied organizations such as clinical specialty societies, disease advocacy groups, federal and local agencies, health plans, and commercial companies. However, CPGs suffer from shortcomings in the guideline development process, often compounding limitations inherent in their scientific evidentiary bases. Certain factors commonly undermine the quality and trustworthiness of CPGs. These include variable quality of individual scientific studies; limitations in systematic reviews (SRs) upon which CPGs are based; lack of transparency of development groups’ methodologies (particularly with respect to evidence quality and strength of recommendation appraisals); failure to convene multi-stakeholder, multi-disciplinary guideline development groups, and corresponding non-reconciliation of conflicting guidelines; unmanaged conflicts of interest (COI); and overall failure to use rigorous methodologies in CPG development. Furthermore, evidence supporting clinical decision making and CPG development relevant to subpopulations, such as patients with comorbidities, the socially and economically disadvantaged, and those with rare conditions, is usually absent.

More generally, the quality of CPG development processes and guideline developer adherence to quality standards have remained unsatisfactory and unreliable for decades. Non-standardized development results in substantial variation in clinical recommendations. At the same time, CPGs produced within a structured environment, in which a systematic procedure or “Guidelines for Guidelines” are available to direct production are more likely to be of higher quality. Furthermore, documentation of guideline development is enhanced by developer use of appraisal instruments or tools for systematically assessing and reporting the quality of guideline development processes. While uniformly endorsed standards for clinical practice guidelines development do not yet exist, there appears to be



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