Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data.

ABSTRACT: Pharmacovigilance is the process of monitoring the emergence of harm from a medicine once it has been licensed and is in use. The aim is to identify new adverse drug reactions (ADRs) or changes in frequency of known ADRs. The last decade has seen increased interest for the use of electronic health records (EHRs) in pharmacovigilance. The causal mechanism of an ADR will often result in the occurrence being time dependent. We propose identifying signals for ADRs based on detecting a variation in hazard of an event using a time-to-event approach. Cornelius et al. proposed a method based on the Weibull Shape Parameter (WSP) and demonstrated this to have optimal performance for ADRs occurring shortly after taking treatment or delayed ADRs, and introduced censoring at varying time points to incr

SUBMITTER: Sauzet O 

PROVIDER: S-EPMC9445551 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature