Trial reportJMIR cardio2025
A Web-Based Tool to Perform a Values Clarification for Stroke Prevention in Patients With Atrial Fibrillation: Design and Preliminary Testing Study.
Trial report in JMIR cardio, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
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Authors and funding
6 authors.
Funding
Abstract
Background: Atrial fibrillation (AF) is associated with an increased risk of stroke. Oral anticoagulation (OAC) is used for stroke prevention in AF, but it also increases bleeding risk. Clinical guidelines do not definitively recommend for or against OAC for patients with borderline stroke risk. Decision-making may benefit from values clarification exercises to communicate risk trade-offs. Objective: This study aimed to evaluate if a visual with a values clarification alters the understanding of the trade-offs of anticoagulation in AF. Methods: Participants aged 45-64 years were recruited across the United States via an online survey. While answering the survey, they were asked to imagine they were newly diagnosed with AF with a CHA2DS2-VASc (congestive heart failure; hypertension; age ≥75 years [doubled]; type 2 diabetes; previous stroke, transient ischemic attack, or thromboembolism [doubled]; vascular disease; age 65 to 75 years; and sex category) score of 1 for men and 2 for women. Eligibility criteria included no diagnosis of AF and no prior OAC use. Participants were randomized to one of three conditions: (1) standard text-based information only (n=255), (2) visual aids showing stroke-risk probabilities (n=218), or (3) visual aids plus a values clarification exercise (visual+VC; n=200). Participants were subrandomized within the 2 visual-based groups to view either a gauge display or an icon array representing stroke risk. All participants read a hypothetical scenario of being newly diagnosed with AF and hypertension. The primary outcome was decision confidence as measured by the SURE (Sure of Myself; Understand Information; Risk-Benefit Ratio; Encouragement) test. Secondary measures included participants' perceived stroke risk reduction, worry about stroke or bleeding, and likelihood to choose OAC. Results: A total of 673 participants completed the survey. The overall SURE test was 61.2% (156/255) for the standard, 66.5% (145/218) for the visual, and 67% (134/200) for the visual+VC group (visual vs standard P=.23; visual+VC vs standard P=.20). Participants were less likely to choose OAC in the visual groups (standard: mean 58.3, SD 30; visual: mean 51.4, SD 32; visual+VC: 51.9, SD 28; P=.03). Participants felt the reduction in stroke risk from an OAC was less in the visual groups (standard: mean 63.8, SD 22; visual: mean 54.2, SD 28; visual+VC: mean 58.6, SD 25; P<.001). Visualization methods (gauge vs icon array) showed no significant differences in overall SURE test results. Participants were less likely to choose OAC and perceived a smaller stroke risk reduction with gauge than icon array (OAC choice: gauge 48.8, icon array 55.4; P=.03; stroke risk reduction: gauge 52.1, icon array 60.4; P=.001). Conclusions: Visual aids can modestly affect decision confidence and perceptions regarding the benefits of OAC but do not significantly alter decision certainty in a scenario where the guidelines do not recommend for or against OAC. Future work should determine the role of a gauge versus icon array visual for decision-making in stroke prevention in AF.
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