Statistical Inference for Non-inferiority of Difference in Proportions of Clustered Matched-pair Data from Multiple Raters
Statistical Inference for Non-inferiority of Difference in Proportions of Clustered Matched-pair Data from Multiple Raters
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来自多个评估者的聚类匹配对数据比例差异的非劣效性统计推断
DOI：
10.1080/10543406.2016.1148709
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发表时间：
2017
影响因子：
1.1
通讯作者：
J.
中科院分区：
文献类型：
--
作者：
Saeki;H.;Tango;T. and Wang;J.
在诊断程序的临床研究中，表明非劣性，疗效通常是根据独立的多个评价者的结果来评估的。对于每个受试者，如果执行两个诊断程序并且评估一些单元，则在两个诊断程序之间和在受试者内，匹配对数据的比例差异是相关的，即，数据被聚集。在这篇文章中，我们提出了一种非劣势检验来推断两种诊断程序之间聚集数据的相关比例的差异。所提出的非劣性检验在蒙特卡罗模拟研究中得到了验证。非自卑测验的经验大小接近名义水平。建议的测试是根据急性蛛网膜下腔出血患者的动脉瘤诊断程序的数据进行的。
In clinical investigations of diagnostic procedures to indicate noninferiority, efficacy is generally evaluated on the basis of results from independent multiple raters. For each subject, if two diagnostic procedures are performed and some units are evaluated, the difference in proportions for matched-pair data is correlated between the two diagnostic procedures and within the subject, i.e. the data are clustered. In this article, we propose a noninferiority test to infer the difference in the correlated proportions of clustered data between the two diagnostic procedures. The proposed noninferiority test was validated in a Monte Carlo simulation study. Empirical sizes of the noninferiority test were close to the nominal level. The proposed test is illustrated on data of aneurysm diagnostic procedures for patients with acute subarachnoid hemorrhage.