Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project.

ABSTRACT:

Background

To assess the causal relationship between a medicinal product and a reported event, relevant information needs to be present. Information elements for assessing cases of exposure to medicinal products during pregnancy were predefined and used in a new tool to assess the quality of information. However, the extent in which the presence or absence of these predefined information elements is associated with the overall clinical quality of these cases, as evaluated by pharmacovigilance experts, remains uncertain.

Objective

We aimed to validate a novel method to assess the clinical quality of information in real-world pregnancy pharmacovigilance case reports.

Methods

The clinical quality of case reports regarding medicinal product exposure and pregnancy-related

SUBMITTER: van Rijt-Weetink YRJ 

PROVIDER: S-EPMC10874330 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature