Wilcoxon-based group sequential designs for comparison of areas under two correlated ROC curves
Wilcoxon-based group sequential designs for comparison of areas under two correlated ROC curves
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DOI：
10.1002/sim.2856
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发表时间：
2008-01-30
影响因子：
2
通讯作者：
Gatsonis, Constantine A.
中科院分区：
文献类型：
--
作者：
Zhou, Xiao-Hua;Li, Sierra M.;Gatsonis, Constantine A.
目前使用固定样本设计进行临床研究，以通过两种诊断模式的受试者工作特征（ROC）曲线评价其相对准确性：累积病例，直到达到预定的样本量，此时，计算并比较ROC曲线下的面积（Radiology 1982; 143：29-36; Radiology 1983; 148：839-843）。在前瞻性ROC研究（Radiology 1990; 175：571-575）中，从临床定义的队列招募参与者，并且在确定明确的诊断证据（“金标准”）之前获得并解释诊断测试信息。在回顾性研究中，从一组患者记录中选择病例，并在不了解“金标准”的情况下解释其诊断测试。进行中华民国的研究需要相当大的努力和资源，特别是收集“金标准”的信息。因此，非常需要寻找比使用固定样本更有效的设计。在本文中，我们讨论了制定和应用组序贯设计（GSDs）的ROC曲线下的面积的非参数Wilcoxon估计的基础上进行比较ROC研究。该方法适用于比较两个测试的ROC曲线面积的连续或顺序尺度上相同的情况下（“配对”设计）与一个读者。采用全球标准定义可大大节省所需案件的数量，从而提高时间和资源的使用效率。版权所有（c）2007约翰威利父子有限公司。
Clinical studies to evaluate the relative accuracies of two diagnostic modalities via their receiver operating characteristic (ROC) curves are currently conducted using fixed sample designs: cases are accrued until a predetermined sample size is achieved and, at that point, the areas under the ROC curves are computed and compared (Radiology 1982; 143:29-36; Radiology 1983; 148:839-843). In prospective ROC studies (Radiology 1990; 175:571-575), participants are recruited from a clinically defined cohort and diagnostic test information is obtained and interpreted in advance of ascertaining the definitive proof of diagnosis ('gold standard'). In retrospective studies, cases are selected from a set of patient records and their diagnostic tests are interpreted without knowledge of the 'gold standard'. The conduct of ROC studies requires considerable effort and resources, particularly for the collection of 'gold standard' information. Thus, it is highly desirable to search for designs which are more efficient than using a fixed sample. In this paper, we discuss the formulation and application of group sequential designs (GSDs) to comparative ROC studies based on non-parametric Wilcoxon estimators of the area under the ROC curves. The approach is applicable to comparisons of ROC curve areas of two tests measured on either continuous or ordinal scales on same cases ('paired' designs) with one reader. The adoption of GSDs may lead to substantial savings in the number of required cases, thus resulting in both time and resource use efficiency. Copyright (c) 2007 John Wiley & Sons, Ltd.