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Lookup NU author(s): Dr Jonathan Richardson, Dr Kenneth Hodson, Dr Laura YatesORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
© 2023, The Author(s).Introduction and Objective: The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated through pregnancy pharmacovigilance (PregPV) research can be heterogenous and difficult to interpret. The aim of this article is to describe the development of a reference framework of core data elements (CDEs) for collection in primary source PregPV studies that can be used to standardise data collection procedures and, thereby, improve data harmonisation and evidence synthesis capabilities. Methods: This CDE reference framework was developed within the Innovative Medicines Initiative (IMI) ConcePTION project by experts in pharmacovigilance, pharmacoepidemiology, medical statistics, risk–benefit communication, clinical teratology, reproductive toxicology, genetics, obstetrics, paediatrics, and child psychology. The framework was produced through a scoping review of data collection systems used by established PregPV datasets, followed by extensive discussion and debate around the value, definition, and derivation of each data item identified from these systems. Results: The finalised listing of CDEs comprises 98 individual data elements, arranged into 14 tables of related fields. These data elements are openly available on the European Network of Teratology Information Services (ENTIS) website (http://www.entis-org.eu/cde). Discussion: With this set of recommendations, we aim to standardise PregPV primary source data collection processes to improve the speed at which high-quality evidence-based statements can be provided about the safety of medication use in pregnancy.
Author(s): Richardson JL, Moore A, Bromley RL, Stellfeld M, Geissbuhler Y, Bluett-Duncan M, Winterfeld U, Favre G, Alexe A, Oliver AM, van Rijt-Weetink YRJ, Hodson KK, Rezaallah B, van Puijenbroek EP, Lewis DJ, Yates LM
Publication type: Article
Publication status: Published
Journal: Drug Safety
Year: 2023
Volume: 46
Pages: 479-491
Online publication date: 28/03/2023
Acceptance date: 06/03/2023
Date deposited: 12/04/2023
ISSN (print): 0114-5916
ISSN (electronic): 1179-1942
Publisher: Springer
URL: https://doi.org/10.1007/s40264-023-01291-7
DOI: 10.1007/s40264-023-01291-7
PubMed id: 36976447
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