From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
Por:
Thurin NH, Pajouheshnia R, Roberto G, Dodd C, Hyeraci G, Bartolini C, Paoletti O, Nordeng H, Wallach-Kildemoes H, Ehrenstein V, Dudukina E, MacDonald T, De Paoli G, Loane M, Damase-Michel C, Beau AB, Droz-Perroteau C, Lassalle R, Bergman J, Swart K, Schink T, Cavero-Carbonell C, Barrachina-Bonet L, Gomez-Lumbreras A, Giner-Soriano M, Aragón M, Neville AJ, Puccini A, Pierini A, Ientile V, Trifirò G, Rissmann A, Leinonen MK, Martikainen V, Jordan S, Thayer D, Scanlon I, Georgiou ME, Cunnington M, Swertz M, Sturkenboom M and Gini R
Publicada:
1 ene 2022
Ahead of Print:
1 nov 2021
Resumen:
In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project-Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation-with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population.
Filiaciones:
Thurin NH:
Bordeaux PharmacoEpi, INSERM CIC-P1401, Univ. Bordeaux, Bordeaux, France
Pajouheshnia R:
Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
Roberto G:
Agenzia regionale di sanità della Toscana, Florence, Italy
Dodd C:
PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway
Hyeraci G:
Agenzia regionale di sanità della Toscana, Florence, Italy
Bartolini C:
Agenzia regionale di sanità della Toscana, Florence, Italy
Paoletti O:
Agenzia regionale di sanità della Toscana, Florence, Italy
Nordeng H:
PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway
Wallach-Kildemoes H:
PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway
Ehrenstein V:
Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark
Dudukina E:
Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark
MacDonald T:
MEMO Research, School of Medicine, University of Dundee, Dundee, UK
De Paoli G:
MEMO Research, School of Medicine, University of Dundee, Dundee, UK
Loane M:
Institute of Nursing and Health Research, Ulster University, Newtownabbey, UK
Damase-Michel C:
INSERM, CERPOP: SPHERE, CIC 1436, Université de Toulouse, Toulouse, France
Beau AB:
INSERM, CERPOP: SPHERE, CIC 1436, Université de Toulouse, Toulouse, France
Droz-Perroteau C:
Bordeaux PharmacoEpi, INSERM CIC-P1401, Univ. Bordeaux, Bordeaux, France
Lassalle R:
Bordeaux PharmacoEpi, INSERM CIC-P1401, Univ. Bordeaux, Bordeaux, France
Bergman J:
Department of Genetics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
Swart K:
PHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands
Schink T:
Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany
:
Fundació per al Foment de la Investigació Sanitària i Biomèdica de la Comunitat Valenciana (FISABIO), Valencia, Spain
:
Fundació per al Foment de la Investigació Sanitària i Biomèdica de la Comunitat Valenciana (FISABIO), Valencia, Spain
Gomez-Lumbreras A:
Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Spain
Giner-Soriano M:
Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Spain
Aragón M:
Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Spain
Neville AJ:
IMER Registry (Emila Romagna Registry of Birth Defects), Center of Epidemiology for Clinical Research, University of Ferrara, Ferrara, Italy
Puccini A:
Drug Policy Service, Emilia Romagna Region Health Authority, Bologna, Italy
Pierini A:
Epidemiology of Rare Diseases and Congenital Anomalies Unit, National Research Council-Institute of Clinical Physiology (CNR-IFC), Pisa, Italy
Ientile V:
Department of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy
Trifirò G:
Department of Diagnostics and Public Health, University of Verona, Verona, Italy
Rissmann A:
Malformation Monitoring Centre Saxony-Anhalt, Medical Faculty, Otto-von-Guericke-University, Magdeburg, Germany
Leinonen MK:
Finnish Institute for Health and Welfare, Helsinki, Finland
Martikainen V:
Finnish Institute for Health and Welfare, Helsinki, Finland
Jordan S:
Faculty of Health and Life Science, Swansea University, Swansea, UK
Thayer D:
Faculty of Health and Life Science, Swansea University, Swansea, UK
Scanlon I:
Faculty of Health and Life Science, Swansea University, Swansea, UK
Georgiou ME:
GlaxoSmithKline, Stevenage, UK
Cunnington M:
GlaxoSmithKline, Stevenage, UK
Swertz M:
Department of Genetics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
Sturkenboom M:
Department Datascience and Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands
Gini R:
Agenzia regionale di sanità della Toscana, Florence, Italy
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