Quantitative signal detection using spontaneous ADR reporting
被引:658
作者:
Bate, A.
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机构:
WHO Collaborating Ctr Int Drug Monitoring, S-75140 Uppsala, Sweden
Brunel Univ, Dept Informat Syst & Comp, London, EnglandWHO Collaborating Ctr Int Drug Monitoring, S-75140 Uppsala, Sweden
Bate, A.
[1
,3
]
Evans, S. J. W.
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机构:
Univ London, London Sch Hyg & Trop Med, London WC1E 7HU, EnglandWHO Collaborating Ctr Int Drug Monitoring, S-75140 Uppsala, Sweden
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
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.
机构:
Univ Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, JapanUniv Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, Japan
Yokotsuka, M
;
Aoyama, M
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机构:
Univ Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, JapanUniv Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, Japan
Aoyama, M
;
Kubota, K
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机构:
Univ Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, JapanUniv Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, Japan
机构:
Univ Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, JapanUniv Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, Japan
Yokotsuka, M
;
Aoyama, M
论文数: 0引用数: 0
h-index: 0
机构:
Univ Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, JapanUniv Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, Japan
Aoyama, M
;
Kubota, K
论文数: 0引用数: 0
h-index: 0
机构:
Univ Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, JapanUniv Tokyo, Fac Med, Dept Pharmacoepidemiol, Bunkyo Ku, Tokyo 1138655, Japan