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

Yrea R J van Rijt-Weetink Antoine C G Egberts Florence P A M van Hunsel David John Lewis Laura M Yates Ursula Winterfeld Eugene P van Puijenbroek

Published in: Drug safety (2024)

The tool described in this study using the presence and relevance of elements of information is the first designed, validated and standardised method for the assessment of the quality of information of case reports in pregnancy pharmacovigilance data. This method confers less inter-rater variability compared with a quality assessment by experts of pregnancy-related pharmacovigilance data.

Keyphrases

adverse drug
preterm birth
drug induced
electronic health record
pregnancy outcomes
quality improvement
case report
big data
healthcare
emergency department
social media
data analysis