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Updated: Dec 31, 2025

Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics
Published on: June 17, 2022
Targeted test evaluation: a framework for designing diagnostic accuracy studies with clear study hypotheses
Daniël A Korevaar1, Gowri Gopalakrishna2, Jérémie F Cohen3,4
11Department of Respiratory Medicine, Academic Medical Center, Amsterdam University Medical Centers, Amsterdam, the Netherlands.
Abstract:
Most randomized controlled trials evaluating medical interventions have a pre-specified hypothesis, which is statistically tested against the null hypothesis of no effect. In diagnostic accuracy studies, study hypotheses are rarely pre-defined and sample size calculations are usually not performed, which may jeopardize scientific rigor and can lead to over-interpretation or "spin" of study findings. In this paper, we propose a strategy for defining meaningful hypotheses in diagnostic accuracy studies. Based on the role of the index test in the clinical pathway and the downstream consequences of test results, the consequences of test misclassifications can be weighed, to arrive at minimally acceptable criteria for pre-defined test performance: levels of sensitivity and specificity that would justify the test's intended use. Minimally acceptable criteria for test performance should form the basis for hypothesis formulation and sample size calculations in diagnostic accuracy studies.
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