ArticlePharmacoepidemiology and drug safety2014
The upper bound to the Relative Reporting Ratio-a measure of the impact of the violation of hidden assumptions underlying some disproportionality methods used in signal detection.
Article in Pharmacoepidemiology and drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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6 citing papers in PubMed.
- The Pitfalls of Disproportionality Analysis: Insights on Their Interwoven Complexity and a Front-End Mitigation Strategy.Drug safety · 2026Article
- Charting and Sidestepping the Pitfalls of Disproportionality Analysis.Drug safety · 2026Review
- Observed Versus Expected Analysis-How Does It Fit in the Pharmacovigilance Toolkit?Drug safety · 2025Review
- Pillars and Pitfalls of the New Pharmacovigilance Legislation: Consequences for the Identification of Adverse Drug Reactions Deriving From Abuse, Misuse, Overdose, Occupational Exposure, and Medication Errors.Frontiers in pharmacology · 2018Article
- Social media for arthritis-related comparative effectiveness and safety research and the impact of direct-to-consumer advertising.Arthritis research & therapy · 2017Article
- Use of logistic regression to combine two causality criteria for signal detection in vaccine spontaneous report data.Drug safety · 2014Article
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2 authors.
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Abstract
purposeFor disproportionality measures based on the Relative Reporting Ratio (RRR) such as the Information Component (IC) and the Empirical Bayesian Geometrical Mean (EBGM), each product and event is assumed to represent a negligible fraction of the spontaneous report database (SRD). Here, we provide the tools for allowing signal detection experts to assess the consequence of the violation of this assumption on their specific SRD.
methodsFor each product-event pair (P-E), a worst-case scenario associated all the reported events-of-interest with the product of interest. The values of the RRR under this scenario were measured for different sets of stratification factors using the GlaxoSmithKline vaccines SRD. These values represent the RRR upper bound that RRR cannot exceed whatever the true strength of association.
resultsDepending on the choice of stratification factors, the RRR could not exceed an upper bound of 2 for up to 2.4% of the P-Es. For Engerix™, 23.4% of all reports in the SDR, the RRR could not exceed an upper bound of 2 for up to 13.8% of pairs. For the P-E Rotarix™-Intussusception, the choice of stratification factors impacted the upper bound to RRR: from 52.5 for an unstratified RRR to 2.0 for a fully stratified RRR.
conclusionsThe quantification of the upper bound can indicate whether measures such as EBGM, IC, or RRR can be used for SRD for which products or events represent a non-negligible fraction of the entire SRD. In addition, at the level of the product or P-E, it can also highlight detrimental impact of overstratification.
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