Measuring clinical uncertainty and equipoise by applying the agreement study methodology to patient management decisions
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(2020) 20:214
RESEARCH ARTICLE
Open Access
Measuring clinical uncertainty and equipoise by applying the agreement study methodology to patient management decisions Robert Fahed1, Tim E. Darsaut2, Behzad Farzin3, Miguel Chagnon4 and Jean Raymond3*
Abstract Background: Clinical uncertainty and equipoise are vague notions that play important roles in contemporary problems of medical care and research, including the design and conduct of pragmatic trials. Our goal was to show how the reliability study methods normally used to assess diagnostic tests can be applied to particular management decisions to measure the degree of uncertainty and equipoise regarding the use of rival management options. Methods: We first use thrombectomy in acute stroke as an illustrative example of the method we propose. We then review, item by item, how the various design elements of diagnostic reliability studies can be modified in order to measure clinical uncertainty. Results: The thrombectomy example shows sufficient disagreement and uncertainty to warrant the conduct of additional randomized trials. The general method we propose is that a sufficient number of diverse individual cases sharing a similar clinical problem and covering a wide spectrum of clinical presentations be assembled into a portfolio that is submitted to a variety of clinicians who routinely manage patients with the clinical problem. Discussion: Clinicians are asked to independently choose one of the predefined management options, which are selected from those that would be compared within a randomized trial that would address the clinical dilemma. Intra-rater agreement can be assessed at a later time with a second evaluation. Various professional judgments concerning individual patients can then be compared and analyzed using kappa statistics or similar methods. Interpretation of results can be facilitated by providing examples or by translating the results into clinically meaningful summary sentences. Conclusions: Measuring the uncertainty regarding management options for clinical problems may reveal substantial disagreement, provide an empirical foundation for the notion of equipoise, and inform or facilitate the design/conduct of clinical trials to address the clinical dilemma. Keywords: Equipoise, Uncertainty, Randomized trials, Methodology, Clinical decision-making, Agreement, Reliability, Kappa
* Correspondence: [email protected] 3 Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier Universitaire de Montréal – CHUM, 1000 Saint-Denis street, room D03-5462B, Montreal, QC H2X 0C1, Canada Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if change
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