Sample size calculations in studies of test accuracy

1998/08/01 by Nancy A Obuchowski, Nancy A. Obuchowski · 1 citation
Decision Sciences · Mathematics · #Meta-analysis and systematic reviews #Statistical Methods and Bayesian Inference #Statistical Methods in Clinical Trials

paper · doi:10.1177/096228029800700405

openalex publication_date 1998/08/01 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/15

Abstract

Methods for determining sample size for studies of the accuracy of diagnostic tests are reviewed. Several accuracy indices are considered, including sensitivity and specificity, the full and partial area under the receiver operating characteristic curve, the sensitivity at a fixed false positive rate, and the likelihood ratio. Sample size formulae are presented for studies evaluating a single test and studies comparing the accuracy of tests. Four real examples illustrate the concepts involved in sample size determination. Lastly, various study design issues are discussed, such as sampling methods, choices in format for the test results, and the issue of replicated readings.

Citations

• Statistical Methodology: I. Incorporating the Prevalence of Disease into the Sample Size Calculation for Sensitivity and Specificity
• The meaning and use of the area under a receiver operating characteristic (ROC) curve.

Cited by

• Development and Validation of the First FDA Authorized Artificial Intelligence/Machine Learning Diagnostic Tool for the Prediction of Sepsis Risk

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