Journal of evaluation in clinical practice
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When evidence-based medicine (EBM) became established, its dominant rhetoric was empiricist, in spite of rationalist elements in its practice. Exploring some of the key statements about EBM down the years, the paper examines the tensions between empiricism and rationalism and argues for a rationalist turn in EBM to help to develop the next generation of scholarship in the field.
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The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework has been presented as the best method available for developing clinical recommendations. GRADE has undergone a series of modifications. Here, we present the first part of a three article series examining the evolution of GRADE. Our purpose is to explore if (and if so, how) GRADE provides: (1) a justification (ie, theoretical and/or empirical) for why the criteria/components under consideration in the system are included (and other factors excluded), as well as why some criteria/components where added/modified in the evolution process, (2) clear and functional (ie, how to operationalize them) definitions of the included criteria/components, and (3) instruction and justification for how all the criteria/components are to be integrated when determining a recommendation. In part 1 of the series, we examine the first two versions of GRADE. ⋯ This article revealed an absence of a justification (theoretical and/or empirical) to support important aspects of the GRADE framework, as well as a lack of clear instruction on how to operationalize the criteria and components in the framework. These issues limit one's ability to scientifically assess the appropriateness of GRADE for determining clinical recommendations.
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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.
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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 evidence based medicine movement has championed the need for objective and transparent methods of clinical guideline development. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was developed for that purpose. Central to this framework is criteria for assessing the quality of evidence from clinical studies and the impact that body of evidence should have on our confidence in the clinical effectiveness of a therapy under examination. ⋯ Finally, the GRADE method is unclear on how to integrate evidence grades with other important factors, such as patient preferences, and trade-offs between costs, benefits, and harms when proposing a clinical practice recommendation. Much of the GRADE method requires judgement on the part of the user, making it unclear as to how the framework reduces bias in recommendations or makes them more transparent-both goals of the programme. It is our view that the issues presented in this paper undermine GRADE's justificatory scheme, thereby limiting the usefulness of GRADE as a tool for developing clinical recommendations.