Measuring Clinical Uncertainty and Equipoise by Applying the Agreement Study Methodology to Patient Management Decisions

Abstract

Background: Clinical dilemmas in the treatment of patients translate into disagreements in decision-making. Such disagreements can reveal clinical uncertainty that should be addressed through care research. Our goal was to explore the use of reliability study methods to measure the degree of clinical uncertainty and equipoise regarding the use of rival management options prior to the conduct of randomized trials. Methods: The study design resembles an inter-/intra-observer diagnostic reliability study. A portfolio of a sufficient number of diverse individual patients sharing a similar clinical problem and covering a wide spectrum of clinical presentations can be independently submitted to a variety of clinicians who manage that problem. Clinicians are asked to choose one of the predefined management options that are involved in the clinical dilemma. Intra-rater agreement can be assessed at a later time with a second evaluation. Results: Descriptive statistics are presented, and results analyzed using kappa statistics. Interpretation of results can be facilitated by providing examples or by translating the results into clinically meaningful summary sentences. Reporting should follow standard guidelines. Conclusions: Measuring the uncertainty regarding management options for clinical problems may reveal disagreements, provide an empirical foundation for the notion of equipoise, and inform or facilitate the design/conduct of clinical trials to address the clinical dilemma.