Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study.

ABSTRACT:

Background and aim

Disproportionality analysis is traditionally used in spontaneous reporting systems to generate working hypotheses about potential adverse drug reactions: the so-called disproportionality signals. We aim to map the methods used by researchers to assess and increase the validity of their published disproportionality signals.

Methods

From a systematic literature search of published disproportionality analyses up until 1 January 2020, we randomly selected and analyzed 100 studies. We considered five domains: (1) rationale for the study, (2) design of disproportionality analyses, (3) case-by-case assessment, (4) use of complementary data sources, and (5) contextualization of the results within existing evidence.

Results

Among the articles, multiple strat

SUBMITTER: Fusaroli M 

PROVIDER: S-EPMC10442263 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature