Sample size estimation of radiological diagnostic tests in multireader multicase design
10.16781/j.CN31-2187/R.20240467
- VernacularTitle:影像诊断试验中多阅片者多病例设计的样本量估计研究
- Author:
Man XIANG
1
;
Huiqin WAN
;
Zhemin PAN
;
Qian HE
;
Yingyi QIN
;
Jia HE
Author Information
1. 同济大学医学院,上海 200092
- Keywords:
radiological diagnostic test;
multireader multicase;
Obuchowski-Rockette method;
sample size
- From:
Academic Journal of Naval Medical University
2025;46(5):693-698
- CountryChina
- Language:Chinese
-
Abstract:
Objective To estimate the sample size of radiological diagnostic tests in multireader multicase(MRMC)design,and to explore the numbers of readers and cases under 3 different inference situations:random-reader random-case,fixed-reader random-case,and random-reader fixed-case.Methods The images of 114 participants(45 cases diagnosed as aortic coarctation by the gold standard)in the Van Dyke dataset were used,and 5 radiologists read these images under 2 different magnetic resonance imaging(MRI)sequences(Spin-echo and Cine MRI)to obtain the pre-experiment data.Then Obuchowski-Rockette method was used to estimate sample size.Results The mean area under curve(AUC)of aortic coarctation determined by radiologists was 0.941(95%confidence interval[CI]0.899-0.983)with the Spin-echo MRI sequence,and 0.897(95%CI 0.837-0.957)with the Cine MRI sequence.When the effect size was 0.044 and the number of readers was 5,we needed 337 participants for random-reader random-case,162 participants for fixed-reader random-case,and 282 participants for random-reader fixed-case.Conclusion In MRMC design,we need both the number of readers and cases;the larger the number of readers,the smaller the cases required.We need more samples under the situation of random-reader random-case,when the number of readers is≥5.
