Quantitative signal detection using spontaneous ADR reporting

被引:658
作者
Bate, A. [1 ,3 ]
Evans, S. J. W. [2 ]
机构
[1] WHO Collaborating Ctr Int Drug Monitoring, S-75140 Uppsala, Sweden
[2] Univ London, London Sch Hyg & Trop Med, London WC1E 7HU, England
[3] Brunel Univ, Dept Informat Syst & Comp, London, England
关键词
spontaneous reports; data mining; signal detection; ADVERSE DRUG-REACTIONS; POSTMARKETING SURVEILLANCE; STATISTICAL METHODOLOGY; NEURAL-NETWORK; SYSTEM VAERS; ODDS RATIO; PHARMACOVIGILANCE; GENERATION; DATABASE; SAFETY;
D O I
10.1002/pds.1742
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
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. Copyright (C) 2009 John Wiley & Sons, Ltd.
引用
收藏
页码:427 / 436
页数:10
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