Journal of evaluation in clinical practice
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In modern philosophy, the concept of truth has been problematized from different angles, yet in evidence-based health care (EBHC), it continues to operate hidden and almost undisputed through the linked concept of "bias." To prevent unwarranted relativism and make better inferences in clinical practice, clinicians may benefit from a closer analysis of existing assumptions about truth, validity, and reality. In this paper, we give a brief overview of several important theories of truth, notably the ideal limit theorem (which assumes an ultimate and absolute truth towards which scientific inquiry progresses), the dominant way truth is conceptualized in the discourse and practice of EBHC. We draw on Belgian philosopher Isabelle Stengers' work to demonstrate that bias means one thing if one assumes a world of hard facts "out there," waiting to be collected. ⋯ Most importantly, it casts doubt on the ideal limit theory as it applies to the single case scenario of the clinical encounter, the cornerstone of EBHC. To the extent that the goal of EBHC is to support inferencing in the clinical encounter, then the ideal limit as the sole concept of truth appears to be conceptually insufficient. We contend that EBHC could usefully incorporate a more pluralist understanding of truth and bias and provide an example how this would work out in a clinical scenario.
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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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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.