Leveraging the Variability of Pharmacovigilance Disproportionality Analyses to Improve Signal Detection Performances.

ABSTRACT: Background: A plethora of methods and models of disproportionality analyses for safety surveillance have been developed to date without consensus nor a gold standard, leading to methodological heterogeneity and substantial variability in results. We hypothesized that this variability is inversely correlated to the robustness of a signal of disproportionate reporting (SDR) and could be used to improve signal detection performances. Methods: We used a validated reference set containing 399 true and false drug-event pairs and performed, with a frequentist and a Bayesian disproportionality method, seven types of analyses (model) for which the results were very unlikely to be related to actual differences in absolute risks of ADR. We calculated sensitivity, specificity and plotted

SUBMITTER: Khouri C 

PROVIDER: S-EPMC8193489 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature