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J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.

Sample size estimation in diagnostic test studies of biomedical informatics.

Author information

1
Dept of Social Sciences and Health, Babol University of Medical Sciences, Babol, Iran. Electronic address: drhajian@yahoo.com.

Abstract

OBJECTIVES:

This review provided a conceptual framework of sample size calculations in the studies of diagnostic test accuracy in various conditions and test outcomes.

METHODS:

The 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.

RESULTS:

The 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.

CONCLUSION:

This 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.

KEYWORDS:

Area under the curve; Diagnostic studies; ROC analysis; Sample size; Sensitivity; Specificity

PMID:
24582925
DOI:
10.1016/j.jbi.2014.02.013
[Indexed for MEDLINE]
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