期刊
THERAPEUTIC INNOVATION & REGULATORY SCIENCE
卷 -, 期 -, 页码 -出版社
SPRINGER HEIDELBERG
DOI: 10.1177/2168479019874059
关键词
clinical trials; interobserver agreement; Cohen kappa; repeated measures; biased estimator; simulation; central reading
Background: Cohen's kappa is a statistic that estimates interobserver agreement. It was originally introduced to help develop diagnostic tests. Interpretative readings of 2 observers, for example, of a mammogram or other imaging, were compared at a single point in time. It is known that kappa depends on the prevalence of disease and that, therefore, kappas across different settings are hard to compare. Methods: Using simulation, we examine an analogous situation, not previously described, that occurs in clinical trials where sequential measurements are obtained to evaluate disease progression or clinical improvement over time. Results: We show that weighted kappa, used for multilevel outcomes, changes during the trial even if we keep the performance of the observer constant. Conclusions: Kappa and closely related measures can therefore only be used with great difficulty, if at all, in quality assurance in clinical trials.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据