Quantitative signal detection using spontaneous ADR reporting
- PMID: 19358225
- DOI: 10.1002/pds.1742
Quantitative signal detection using spontaneous ADR reporting
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.
Similar articles
-
The reporting odds ratio and its advantages over the proportional reporting ratio.Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):519-23. doi: 10.1002/pds.1001. Pharmacoepidemiol Drug Saf. 2004. PMID: 15317031 Review.
-
A comparison of measures of disproportionality for signal detection on adverse drug reaction spontaneous reporting database of Guangdong province in China.Pharmacoepidemiol Drug Saf. 2008 Jun;17(6):593-600. doi: 10.1002/pds.1601. Pharmacoepidemiol Drug Saf. 2008. PMID: 18432629
-
Comparison of data mining methodologies using Japanese spontaneous reports.Pharmacoepidemiol Drug Saf. 2004 Jun;13(6):387-94. doi: 10.1002/pds.964. Pharmacoepidemiol Drug Saf. 2004. PMID: 15170768
-
A computerized system for signal detection in spontaneous reporting system of Shanghai China.Pharmacoepidemiol Drug Saf. 2009 Feb;18(2):154-8. doi: 10.1002/pds.1695. Pharmacoepidemiol Drug Saf. 2009. PMID: 19115240
-
Data mining in spontaneous reports.Basic Clin Pharmacol Toxicol. 2006 Mar;98(3):324-30. doi: 10.1111/j.1742-7843.2006.pto_232.x. Basic Clin Pharmacol Toxicol. 2006. PMID: 16611210 Review.
Cited by
-
Hepatotoxicity of antipsychotics: an exploratory pharmacoepidemiologic and pharmacodynamic study integrating FAERS data and in vitro receptor-binding affinities.Front Psychiatry. 2024 Oct 14;15:1479625. doi: 10.3389/fpsyt.2024.1479625. eCollection 2024. Front Psychiatry. 2024. PMID: 39469476 Free PMC article.
-
Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database.J Pharm Health Care Sci. 2016 Jun 21;2:14. doi: 10.1186/s40780-016-0048-5. eCollection 2016. J Pharm Health Care Sci. 2016. PMID: 27330825 Free PMC article.
-
Cardiovascular, ocular and bone adverse reactions associated with thiazolidinediones: a disproportionality analysis of the US FDA adverse event reporting system database.Drug Saf. 2012 Apr 1;35(4):315-23. doi: 10.2165/11596510-000000000-00000. Drug Saf. 2012. PMID: 22376166
-
Vaccine-based subgroup analysis in VigiBase: effect on sensitivity in paediatric signal detection.Drug Saf. 2012 Apr 1;35(4):335-46. doi: 10.2165/11598120-000000000-00000. Drug Saf. 2012. PMID: 22435344
-
The atypical antipsychotics and sexual dysfunction: a pharmacovigilance-pharmacodynamic study.Front Pharmacol. 2024 Jul 9;15:1423075. doi: 10.3389/fphar.2024.1423075. eCollection 2024. Front Pharmacol. 2024. PMID: 39045047 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
Research Materials