摘要：

ObjectivesThis review provided a conceptual framework of sample size calculations in the studies of diagnostic test accuracy in various conditions and test outcomes.MethodsThe formulae of sample size calculations for estimation of adequate sensitivity/specificity, likelihood ratio and AUC as an overall index of accuracy and also for testing in single modality and comparing two diagnostic tasks have been presented for desired confidence interval.ResultsThe required sample sizes were calculated and tabulated with different levels of accuracies and marginal errors with 95% confidence level for estimating and for various effect sizes with 80% power for purpose of testing as well. The results show how sample size is varied with accuracy index and effect size of interest.ConclusionThis would help the clinicians when designing diagnostic test studies that an adequate sample size is chosen based on statistical principles in order to guarantee the reliability of study.Article Outline1. Introduction2. Examples3. Diagnostic accuracy and classification performance4. A review of sample size consideration5. Factors affecting on sample size for diagnostic accuracy6. Sample size for studies with binary test outcome6.1. Sample size for adequate sensitivity/specificity6.2. Sample size for testing sensitivity (or specificity) of single diagnostic test6.3. Sample size for comparing the sensitivity (or specificity) of two diagnostic tests6.4. Sample size for likelihood ratio estimation7. Sample size for studies of ROC index of accuracy7.1. Sample size for estimating accuracy index7.2. Sample size for testing accuracy of quantitative diagnostic test of single modality7.3. Sample size for comparing accuracy of two diagnostic tests8. Sample size calculation9. Results of sample size calculation10. Illustration of analysis and sample size with an example11. Summary guideline12. Discussion. Appendix A. Appendix B. Appendix CReferences

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