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Informatics

Category: Methods in Pharmacoepidemiology

Poster Gallery-Informatics

(P-071) Inception to Conception: A Conceptual Framework for Characterizing Pharmacoepidemiologic Data Sources. a Study from the Conception Project

Location: Poster Gallery-Informatics

    Presenting Author(s)

  • Romin Pajouheshnia

    Junior Assistant Professor
    University of Utrecht
    Utrecht, Utrecht, Netherlands

    • Co-Author(s)

  • Nicolas H. Thurin

    Université de bordeaux
    Bordeaux, Gironde, France

  • GR

    Giuseppe Roberto

    Agenzia Regionale di Sanità della Toscana, Firenze, Italy

  • CD

    Caitlin Dodd

    Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Netherlands

  • GH

    Giulia Hyeraci

    Agenzia Regionale di Sanità Toscana
    Firenze, Firenze, Italy

  • CB

    Claudia C. Bartolini

    ARS Toscana
    Firenze, Firenze, Italy

  • OP

    Olga Paoletti

    Agenzia regionale di sanità della Toscana, Italy

  • HN

    Hedvig Nordeng

    PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway

  • HW

    Helle Wallach-Kildemoes

    PharmaSafe Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway

  • Vera Ehrenstein, MPH, DSc

    Professor
    Department Of Clinical Epidemiology, Aarhus University, Aarhus, Denmark, Denmark

  • Elena Dudukina

    Department of Clinical Epidemiology, Aarhus University, Denmark

  • TM

    Thomas MacDonald

    MEMO Research, School of Medicine, University of Dundee, Ninewells Hospital, Dundee, United Kingdom

  • GD

    Giorgia De Paoli

    University of Dundee, United Kingdom

  • ML

    Maria Loane

    Institute of Nursing & Health Research, Ulster University, Northern Ireland, United Kingdom

  • CD

    Christine Damase-Michel

    Université de Toulouse, UPS, CHU Toulouse, INSERM, CERPOP: SPHERE, CIC 1436, Toulouse
    Toulouse, France

  • AB

    Anna-Belle Beau

    CHU Toulouse, Université de Toulouse, INSERM, CERPOP: SPHERE, Toulouse, France

  • CD

    Cécile Droz-Perroteau

    Univ. Bordeaux, INSERM CIC-P 1401, Bordeaux PharmacoEpi, 33000 Bordeaux, France, France

  • RL

    Régis Lassalle

    Bordeaux PharmacoEpi, INSERM CIC1401, Université de BORDEAUX, France

  • KS

    Karin M.A. Swart

    PHARMO Institute
    Utrecht, Utrecht, Netherlands

  • TS

    Tania Schink, n/a

    Leibniz Institute for Prevention Research and Epidemiology – BIPS GmbH, Bremen, Germany

  • CC

    Clara Cavero-Carbonell

    Fundació per al Foment de la Investigació Sanitaria i Biomédica de la Comunitat Valenciana (FISABIO), Spain

  • LB

    Laia Barrachina-Bonet

    Fundació per al Foment de la Investigació Sanitaria i Biomédica de la Comunitat Valenciana (FISABIO), Spain

  • MG

    Maria Giner-Soriano

    Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol). Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain

  • MA

    Maria Aragon

    Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona , Spain, Spain

  • AN

    Amanda J Neville

    IMER Registry (Emila Romagna Registry of Birth Defects), Center of Epidemiology for Clinical Research,University of Ferrara Azienda Ospedaliero- Universitaria di Ferrara, Italy

  • AA

    Annarita Armaroli

    Center of Epidemiology for Clinical Research,University of Ferrara Azienda Ospedaliero- Universitaria di Ferrara, Italy

  • AP

    Aurora Puccini

    Drug Policy Service, Emilia Romagna Region Health Authority, Bologna, Italy, Italy

  • AP

    Anna Pierini

    Epidemiology of Rare Diseases and Congenital Anomalies Unit, National Research Council-Institute of Clinical Physiology (CNR-IFC), Pisa, Italy

  • VI

    Valentina Ientile

    Department of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy

  • GT

    Gianluca Trifirò

    Department of Diagnostics and Public Health, University of Verona, Verona, Italy

  • MG

    Miriam Gatt

    Directorate for Health Information and Research, Malta, Malta

  • AR

    Anke Rissmann

    Malformation Monitoring Centre Saxony-Anhalt, Medical Faculty, Otto-von-Guericke-University Magdeburg, Leipziger Straße 44, D-39120, Magdeburg, Germany

  • ML

    Maarit K. Leinonen

    Finnish Institute for Health and Welfare, Finland

  • VM

    Visa Martikainen

    Finnish Institute for Health and Welfare, Finland

  • SJ

    Sue Jordan

    Swansea University, United Kingdom

  • MG

    Mary E. Georgiou

    GlaxoSmithKline
    Brentford, United Kingdom

  • Marianne C. Cunnington, PhD

    GlaxoSmithKline
    London, United Kingdom

  • MS

    Morris A. Swertz

    University of Groningen, University Medical Center Groningen, Dept Genetics

  • Miriam Sturkenboom

    Department Datascience & Biostatistics, University Medical Center Utrecht, Netherlands

  • RG

    Rosa Gini

    Researcher/statistician
    Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy, Italy

Background: The IMI ConcePTION project was initiated to develop an ecosystem for the generation of robust evidence on medicines safety in pregnancy and breastfeeding based on pre-clinical and human data. Analysis of distributed and heterogeneous health data requires standardized tools that run against a common data model (CDM). In the past 15 years many tools for distributed analytics, including CDMs, have been tested in Europe and beyond. We capitalized on these learnings and propose a CDM to address the needs of the ConcePTION ecosystem.

Objectives: To develop a CDM that captures the richness of available European health data sources based on a process that optimises transparency in mapping of content with separate syntactic and semantic harmonization, to enable evaluation of medicines use, effectiveness and safety during pregnancy and breastfeeding.

Methods: Data access providers (DAPs) involved in the ConcePTION project were selected on the basis of the data source they have access to and experience in the field. Comprehensive qualitative interviews lasting 120 minutes were conducted between DAPs and pairs of interviewers. Data from the interview answer forms were extracted in a standard manner and synthesised to i) develop a framework for describing the data sources, ii) support the development of the CDM, and iii) support the design of the Extract Transform Load (ETL) procedure to the ConcePTION CDM.

Results: Twenty DAPs were interviewed, with access to heterogeneous but complementary data (e.g. hospital discharge records, dispensed prescription records, birth and mortality registries, congenital anomaly registries). The CDM we proposed based on the evaluation of the interviews is divided into 4 sections: 1) Routine healthcare data (data generated during routine healthcare), 2) Surveillance data (data generated out of routine healthcare, e.g. cohorts, ad-hoc registries), 3) Curated tables (derived and summarized information of interest, e.g. birth date, mother-child linkage) and 4) Metadata (information about the data source), without prior semantic harmonization of the vocabularies used.

Conclusions: The analysis of data source descriptions and interviews with DAPs in the ConcePTION project demonstrated the unique features of European data sources and led to the development of the ConcePTION CDM. This will allow rapid implementation of transparent distributed analytics and will next be implemented in studies of medicines use, effectiveness and safety during pregnancy and breastfeeding, and in the general population.