Quantitative signal detection using spontaneous ADR reporting.
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.
Bate
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A
WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. andrew.bate@who-umc.org
Evans
S J W
SJ
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000465:Algorithms; D003627:Data Interpretation, Statistical; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D016247:Information Storage and Retrieval; D016017:Odds Ratio; D017891:Pharmacoepidemiology