Wu Mixia, Shu Yu, Li Zhaohai, Liu Aiyi
College of Applied Sciences, Beijing University of Technology, Beijing, 100124, China.
Abbott Labs Vascular Division, 3200 Lakeside Dr., Santa Clara, 95054, CA, U.S.A.
Stat Med. 2016 Aug 30;35(19):3397-412. doi: 10.1002/sim.6932. Epub 2016 Mar 7.
A sequential design is proposed to test whether the accuracy of a binary diagnostic biomarker meets the minimal level of acceptance. The accuracy of a binary diagnostic biomarker is a linear combination of the marker's sensitivity and specificity. The objective of the sequential method is to minimize the maximum expected sample size under the null hypothesis that the marker's accuracy is below the minimal level of acceptance. The exact results of two-stage designs based on Youden's index and efficiency indicate that the maximum expected sample sizes are smaller than the sample sizes of the fixed designs. Exact methods are also developed for estimation, confidence interval and p-value concerning the proposed accuracy index upon termination of the sequential testing. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.
本文提出了一种序贯设计方法，用于检验二元诊断生物标志物的准确性是否达到最低可接受水平。二元诊断生物标志物的准确性是该标志物敏感性和特异性的线性组合。序贯方法的目标是在标志物准确性低于最低可接受水平的原假设下，使最大期望样本量最小化。基于约登指数和效率的两阶段设计的精确结果表明，最大期望样本量小于固定设计的样本量。同时还开发了精确方法，用于在序贯检验终止时对所提出的准确性指标进行估计、构建置信区间和计算p值。2016年发表。本文为美国政府作品，在美国属于公共领域。
