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Sample Size Calculation for Clinical Trials of Medical Decision Support Systems with Binary Outcome

O Yu Rebrova1, A V Gusev2

  • 1Professor, Department of Medical Cybernetics and Informatics; Pirogov Russian National Research Medical University, 1 Ostrovityanova St., Moscow, 117997, Russia; Professor, Department of Endocrinology, Institute for Higher Education and Additional Professional Training; Endocrinology Research Centre, 11 Dmitriya Ulyanova St., Moscow, 117292, Russia; Leading Researcher, Sector of Dynamic Neural Networks, Department of Neuroinformatics, Center for Optical-Neuron Technologies; Federal State Institution "Scientific Research Institute for System Analysis of the Russian Academy of Sciences", 36/1 Nakhimovsky Prospect, Moscow, 117218, Russia; Chief Researcher, Laboratory of Evidence-Based Medicine and Biostatistics; Mental Health Research Center, 34 Kashirskoye Shosse, Moscow, 115522, Russia.

Sovremennye Tekhnologii V Meditsine
|April 17, 2023
PubMed
Summary

This study details sample size calculations for clinical decision support systems (CDSS) with binary outcomes in diagnostic and predictive models. Proper study design and representativeness are crucial for reliable medical software validation.

Keywords:
binary outcomeclinical decision support systemsclinical trialsdiagnostic modelsexternal validationpredictive modelssample size

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