Objective To explore two methods of sample size estimation in multi-reader multi-case study of radiological diagnostic test and realize them by software. Methods Demonstration programs were conducted in R software using the Van Dyke dataset, calculating combinations of readers and cases using the OR and DBM methods. These serve as pilot test results for multi-reader multi-case studies, providing a reference for parameter settings in subsequent formal experiments. Results When the effect size was 0.044, 6 readers and 247 cases could yield 0.80 power, while with an effect size of 0.088, only 6 readers and 44 cases were needed to reach 80.5% power. The sample sizes calculated using the OR method and the DBM method were consistent, and the same sample size calculation results could be obtained through conversion between the two methods. Conclusion For the estimation of sample size in multi-reader multi-case studies, R software provides a convenient and mature software package for sample size estimation using multi-reader multi-case designs in radiological diagnostic tests, thereby offering a reference for selecting appropriate sample size estimation and statistical analysis methods in radiological diagnostic tests.
Citation：
WAN Huiqin, XIANG Man, PAN Zhemin, QIN Yingyi, HE Qian, HE Jia. Introduction to the sample size estimation methods of multi-reader and multi-case design in radiological diagnostic test and software implementation. Chinese Journal of Evidence-Based Medicine, 2025, 25(5): 555-561. doi: 10.7507/1672-2531.202407148
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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