ArticleFrontiers in drug safety and regulation2023
Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data-a ConcePTION project.
Article in Frontiers in drug safety and regulation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands-A contribution of the ConcePTION project.British journal of clinical pharmacology · 2026Article
- Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm.Drug safety · 2025Article
- Quality of Clinical Information in Pregnancy Pharmacovigilance Data Sources-A Contribution of the ConcePTION Project.Pharmacoepidemiology and drug safety · 2025Article
- Maternal and perinatal health research during emerging and ongoing epidemic threats: a landscape analysis and expert consultation.BMJ global health · 2024Article
- Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project.Drug safety · 2024Article
Corrections and comments
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Authors and funding
8 authors.
Funding
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Abstract
To assess the risk of exposure to a medicinal product during pregnancy in an individual case report, the necessary information should be present, complete and clearly described. Previously designed grading tools were not developed for pregnancy pharmacovigilance data. This study aims to identify the elements that are necessary to assess of the quality of information for risk assessment of medicinal products used during pregnancy. This is a first step in the development of a validated method to assess the clinical quality of case reports in pregnancy pharmacovigilance data. Potential information elements were determined by means of an expert focus group discussion and a survey based on its outcome. This provided an overview of possible information elements to be selected. For the final selection of the elements, a second survey and subsequent focus group discussion was used. Twenty-one information elements within seven categories were identified: information related to the association itself, the event, exposure to the medicinal product, maternal factors, pregnancy, labour, and the child. This study identified elements considered necessary in the assessment of quality of information of case reports in pregnancy pharmacovigilance data, via an extensive four-step process.
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