Journal of evaluation in clinical practice
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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. ⋯ 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.
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As a clinician, I can easily agree with the author that a person's own reality of being healthy is independent of physical evidence or clinical categories and that this perspective should be considered to improve clinical care. However, I cannot follow the assumptions about the nature and working of modern medicine and psychiatry as typically using "black box" and one-size-fits-all treatments in daily practice. I outline several working contexts of doctors where this criticism does only marginally apply or not at all and wonder whether the author might wish, if possible at all from a philosophical viewpoint, to differentiate her concepts with regard to these different contexts. In addition, I think that ill health in the field of psychiatry might have to be dealt with differently than physical ill health.
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The role of mechanistic evidence tends to be under-appreciated in current evidence-based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme seeks to redress this imbalance, by suggesting methods for evaluating mechanistic studies alongside clinical studies. ⋯ Nevertheless, we argue that mechanistic evidence is central to all the key tasks in the drug approval process: in drug discovery and development; assessing pharmaceutical quality; devising dosage regimens; assessing efficacy, harms, external validity, and cost-effectiveness; evaluating adherence; and extending product licences. We recommend that, when preparing for meetings in which any aspect of drug approval is to be discussed, mechanistic evidence should be systematically analysed and presented to the committee members alongside analyses of clinical studies.
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The GRADE framework has been widely adopted as the preferred method for developing clinical practice recommendations. In the first article of our three part series examining the evolution of GRADE, we showed an absence (in the first two versions of GRADE) of a theoretical basis and/or empirical data to support why the presented criteria for determining the quality of evidence regarding the effect estimate and the components under consideration for determining the strength of the recommendation were included and other criteria/components excluded. Furthermore, often, it was not clear how to operationalize the included criteria/components (and integrate them) when using the framework. In part 2 of this series, we examine if version 3 of GRADE offered improvements on previous versions with respect to a justification scheme and how to operationalize the framework's criteria/components. ⋯ While version 3 reveals acknowledgement by the authors of GRADE that the framework is a work in progress, it still lacks a justification scheme (theoretical and/or empirical) to sustain it and clarity in its criteria/components to operationalize it. As was suggested in part 1, such issues limit one's ability to scientifically assess the appropriateness of GRADE for its stated purpose.
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The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework has undergone several modifications since it was first presented as a method for developing clinical practice recommendations. In the previous two articles of this series, we showed that absent, in the first three versions of GRADE, is a justification (theoretical and/or empirical) for why the presented criteria for determining the quality of evidence and the components for determining the strength of a recommendation were included (and others not included) in the framework. Furthermore, it was often not clear how to operationalize and integrate the criteria/components when using the framework. In part 3 of this series, we examine the literature since version 3 to see if the GRADE working group has provided an overall justification scheme for GRADE or clear instruction on how to operationalize and integrate the criteria/components in the framework. ⋯ If we desire that our clinical recommendations be based on scientific teaching rather than faith-based preaching, then the GRADE framework should be justified theoretically and/or empirically. Until such time that the working group provides a theoretical justification that the use of the GRADE framework should produce valid recommendations, and/or empirical evidence to support that it does, enthusiasm for the framework should be tempered.