LAUSR

For over 30 years, "evidence-based" clinical guidelines remained entrenched in an oversimplified, design-based, framework for rating the strength of evidence supporting clinical recommendations. The approach frequently equated the rating of evidence with that of the recommendations themselves. "Grading Recommendations Assessment, Development and Evaluation (GRADE)" has emerged as a proposed antidote to obsolete guideline methodology. GRADE sponsors and collaborators are in the process of attempting to amplify and extend the framework to encompass implementation and adaptation of guidelines, above and beyond the evaluation and rating of clinical research. Alternative schemes and models for such extensions are beginning to appear. This commentary reviews the strengths and weaknesses of GRADE with reference to other recent critiques. It considers the GRADE Working Group's "evidence-to-decision" extension of the evidence rating framework, together with proposed alternatives. It identifies pitfalls of the GRADE system's cooptation of relational processes necessary to the interpretation and uptake of recommendations that properly belong to end-users. It also identifies dangers inherent in blurring important boundaries between clinical and policy applications of guidelines. Finally, it addresses criticisms regarding the lack of a theoretical framework supporting the different facets of the GRADE approach and proposes a social constructivist orientation to clinical guideline development and use. Recommendations are offered to potential guideline developers and users regarding how to draw upon the strengths of the GRADE framework without succumbing to its pitfalls.