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Updated: Jun 16, 2025

Signal Acquisition, Score Interpretation, and Economics of a Non-Invasive Point-of-Care Test for Coronary Artery Disease
Published on: August 9, 2024
Practical and analytical considerations when performing interim analyses in diagnostic test accuracy studies
Susannah Fleming1, Lazaro Mwandigha2, Thomas R Fanshawe3
1Department of Primary Care Health Sciences, University of Oxford, Woodstock Road, Oxford, OX2 6GG, UK. susannah.fleming@phc.ox.ac.uk.
Abstract:
Interim analysis is a common methodology in randomised clinical trials but has received less attention in studies of diagnostic test accuracy. In such studies, early termination for futility may be beneficial if early evidence indicates that a diagnostic test is unlikely to achieve a clinically useful level of diagnostic performance, as measured by the sensitivity and specificity. In this paper, we describe relevant practical and analytical considerations when planning and performing interim analysis in diagnostic accuracy studies, focusing on stopping rules for futility. We present an adaptation of the exact group sequential method for diagnostic testing, with R code provided for implementing this method in practice. The method is illustrated using two simulated data sets and data from a published diagnostic accuracy study for point-of-care testing for SARS-CoV-2. The considerations described in this paper can be used to guide decisions as to when an interim analysis in a diagnostic accuracy study is suitable and highlight areas for further methodological development.
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