Evidence map›Paper›PMID 34826340›Full record

ArticleClinical pharmacology and therapeutics2022

From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding.

Nicolas H Thurin, Romin Pajouheshnia, Giuseppe Roberto, Caitlin Dodd, Giulia Hyeraci, Claudia Bartolini, Olga Paoletti, Hedvig Nordeng, Helle Wallach-Kildemoes, Vera Ehrenstein and 32 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

42 authors at 20 institutions in 9 countries.

Nicolas H ThurinBordeaux PharmacoEpi, INSERM CIC-P1401, Univ. Bordeaux, Bordeaux, France.
Romin PajouheshniaUtrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Giuseppe RobertoAgenzia regionale di sanità della Toscana, Florence, Italy.
Caitlin DoddPharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.
Giulia HyeraciAgenzia regionale di sanità della Toscana, Florence, Italy.
Claudia BartoliniAgenzia regionale di sanità della Toscana, Florence, Italy.
Olga PaolettiAgenzia regionale di sanità della Toscana, Florence, Italy.
Hedvig NordengPharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.
Helle Wallach-KildemoesPharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.
Vera EhrensteinDepartment of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.
Elena DudukinaDepartment of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.
Thomas MacDonaldMEMO Research, School of Medicine, University of Dundee, Dundee, UK.
Giorgia De PaoliMEMO Research, School of Medicine, University of Dundee, Dundee, UK.
Maria LoaneInstitute of Nursing and Health Research, Ulster University, Newtownabbey, UK.
Christine Damase-MichelINSERM, CERPOP: SPHERE, CIC 1436, Université de Toulouse, Toulouse, France.
Anna-Belle BeauINSERM, CERPOP: SPHERE, CIC 1436, Université de Toulouse, Toulouse, France.
Cécile Droz-PerroteauBordeaux PharmacoEpi, INSERM CIC-P1401, Univ. Bordeaux, Bordeaux, France.
Régis LassalleBordeaux PharmacoEpi, INSERM CIC-P1401, Univ. Bordeaux, Bordeaux, France.
Jorieke BergmanDepartment of Genetics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Karin SwartPHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands.
Tania SchinkLeibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany.
Clara Cavero-CarbonellFundació per al Foment de la Investigació Sanitaria i Biomédica de la Comunitat Valenciana (FISABIO), Valencia, Spain.
Laia Barrachina-BonetFundació per al Foment de la Investigació Sanitaria i Biomédica de la Comunitat Valenciana (FISABIO), Valencia, Spain.
Ainhoa Gomez-LumbrerasFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Spain.
Maria Giner-SorianoFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Spain.
María AragónFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Spain.
Amanda J NevilleIMER Registry (Emila Romagna Registry of Birth Defects), Center of Epidemiology for Clinical Research, University of Ferrara, Ferrara, Italy.
Aurora PucciniDrug Policy Service, Emilia Romagna Region Health Authority, Bologna, Italy.
Anna PieriniEpidemiology of Rare Diseases and Congenital Anomalies Unit, National Research Council-Institute of Clinical Physiology (CNR-IFC), Pisa, Italy.
Valentina IentileDepartment of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy.
Gianluca TrifiròDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Anke RissmannMalformation Monitoring Centre Saxony-Anhalt, Medical Faculty, Otto-von-Guericke-University, Magdeburg, Germany.
Maarit K LeinonenFinnish Institute for Health and Welfare, Helsinki, Finland.
Visa MartikainenFinnish Institute for Health and Welfare, Helsinki, Finland.
Sue JordanFaculty of Health and Life Science, Swansea University, Swansea, UK.
Daniel ThayerFaculty of Health and Life Science, Swansea University, Swansea, UK.
Ieuan ScanlonFaculty of Health and Life Science, Swansea University, Swansea, UK.
Mary E GeorgiouGlaxosmithkline, Stevenage, UK.
Marianne CunningtonGlaxosmithkline, Stevenage, UK.
Morris SwertzDepartment of Genetics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Miriam SturkenboomDepartment Datascience and Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands.
Rosa GiniAgenzia regionale di sanità della Toscana, Florence, Italy.
Agenzia Regionale di Sanità della Toscana · ITSwansea University · GBUniversitat Autònoma de Barcelona · ESUniversité de Bordeaux · FRUniversity of Oslo · NOAarhus University · DKAge UK · GBFinnish Institute for Health and Welfare · FIFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESInserm · FRUniversity Medical Center Groningen · NLUniversity of Dundee · GBAgenzia Regionale Prevenzione e Ambiente della Regione Emilia-Romagna · ITIstituto di Fisiologia Clinica · ITLeibniz Institute for Prevention Research and Epidemiology - BIPS · DEOtto-von-Guericke University Magdeburg · DEPharmo Institute · NLUniversity Medical Center Utrecht · NLUniversity of Ferrara · ITUniversity of Messina · IT

Funding

Innovative Medicines Initiative 2 Joint Undertaking 821520
6 · The paper itself

Abstract

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.

Indexed as

Drug-Related Side Effects and Adverse ReactionsHealth Information ExchangeBreast FeedingCommunicationDatabases as TopicDrug Information ServicesEuropeFemaleHumansInformation Storage and RetrievalPregnancy

Identifiers

PMID34826340
PMCPMC9299060
OpenAlexW3215142683

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.