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| 影像诊断试验中多阅片者多病例设计的样本量估计研究 |
| 向蔓1,宛慧琴1,潘喆敏1,何倩2,秦婴逸2,贺佳1,2* |
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(1. 同济大学医学院, 上海 200092;
2. 海军军医大学(第二军医大学)卫生勤务学系军队卫生统计学教研室, 上海 200433
*通信作者) |
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| 摘要: |
| 目的 实现影像诊断试验中多阅片者多病例设计下的样本量估计，探索阅片者和病例均随机、阅片者固定病例随机、阅片者随机病例固定3种情形下阅片者和受试者的数量组合。方法 采用Van Dyke数据集中114例受试者（45例被金标准诊断为主动脉夹层）的影像，并由5名影像科医生在自旋回波（Spin-echo）和电影（Cine）2种序列MRI下的判读结果为预试验数据，使用Obuchowski-Rockette法估计正式试验中所需的样本量。结果 医生在Spin-echo MRI、Cine MRI序列下判别主动脉夹层的平均AUC值分别为0.941（95% CI 0.899～0.983）、0.897（95% CI 0.837～0.957）。当效应量取两者AUC差值0.044、阅片者数量为5时，阅片者和病例均随机、阅片者固定病例随机、阅片者随机病例固定3种情形下分别需要受试者337、162、282例。结论 多阅片者多病例设计在进行样本量估计时需考虑阅片者和受试者两者数量，相同情况下，阅片者人数越多所需的受试者数量越少；3种情形中，阅片者（≥5人）和病例均随机时所需样本量最多。 |
| 关键词: 影像诊断试验 多阅片者多病例 Obuchowski-Rockette法 样本量 |
| DOI：10.16781/j.CN31-2187/R.20240467 |
| 投稿时间：2024-06-30修订日期：2024-10-08 |
| 基金项目:上海市卫生健康委员会新兴交叉领域研究专项（2022JC011），上海市产业协同创新项目（2021-cyxt1-kj10）. |
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| Sample size estimation of radiological diagnostic tests in multireader multicase design |
| XIANG Man1,WAN Huiqin1,PAN Zhemin1,HE Qian2,QIN Yingyi2,HE Jia1,2* |
(1. School of Medicine, Tongji University, Shanghai 200092, China;
2. Department of Military Health Statistics, Faculty of Medical Sevices, Naval Medical University (Second Military Medical University), Shanghai 200433, China
*Corresponding author) |
| 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. |
| Key words: radiological diagnostic test multireader multicase Obuchowski-Rockette method sample size |
