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使用自发药品不良反应报告进行定量信号检测。

Quantitative signal detection using spontaneous ADR reporting.

作者信息

Bate A, Evans S J W

机构信息

WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden.

出版信息

Pharmacoepidemiol Drug Saf. 2009 Jun;18(6):427-36. doi: 10.1002/pds.1742.

Abstract

Quantitative methods are increasingly used to analyse spontaneous reports. We describe the core concepts behind the most common methods, the proportional reporting ratio (PRR), reporting odds ratio (ROR), information component (IC) and empirical Bayes geometric mean (EBGM). We discuss the role of Bayesian shrinkage in screening spontaneous reports, the importance of changes over time in screening the properties of the measures. Additionally we discuss three major areas of controversy and ongoing research: stratification, method evaluation and implementation. Finally we give some suggestions as to where emerging research is likely to lead.

摘要

定量方法越来越多地用于分析自发报告。我们描述了最常用方法背后的核心概念,即比例报告比(PRR)、报告比值比(ROR)、信息成分(IC)和经验贝叶斯几何均值(EBGM)。我们讨论了贝叶斯收缩在筛选自发报告中的作用,以及随时间变化在筛选测量属性方面的重要性。此外,我们还讨论了三个主要的争议和正在进行研究的领域:分层、方法评估和实施。最后,我们对新兴研究可能的发展方向提出了一些建议。

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