Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe

Pharmacoepidemiology and Drug Safety, vol. 33, pp. e5871

Abstract

PURPOSE: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct. METHODS: A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe. RESULTS: A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype. CONCLUSIONS: A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe.

Authors 46

1. Romin Pajouheshnia corresponding

   Utrecht University · RTI Health Solutions

   Affiliation as printed

   Department of Epidemiology RTI Health Solutions Barcelona Spain

   Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht University Utrecht The Netherlands

2. Rosa Gini

   Agenzia Regionale di Sanità della Toscana

   Affiliation as printed

   Agenzia Regionale di Sanità della Toscana Florence Italy

3. Lia Gutiérrez

   RTI Health Solutions

   Affiliation as printed

   Department of Epidemiology RTI Health Solutions Barcelona Spain

4. Morris A. Swertz

   University Medical Center Groningen

   Affiliation as printed

   Department of Genetics University Medical Centre Groningen Groningen The Netherlands

5. Eleanor Hyde

   University Medical Center Groningen

   Affiliation as printed

   Department of Genetics University Medical Centre Groningen Groningen The Netherlands

6. Miriam Sturkenboom

   University Medical Center Utrecht

   Affiliation as printed

   University Medical Centre Utrecht Utrecht The Netherlands

7. Alejandro Arana

   RTI Health Solutions

   Affiliation as printed

   Department of Epidemiology RTI Health Solutions Barcelona Spain

8. Carla Franzoni

   RTI Health Solutions

   Affiliation as printed

   Department of Epidemiology RTI Health Solutions Barcelona Spain

9. Véra Ehrenstein

   Aarhus University · Aarhus University Hospital

   Affiliation as printed

   Department of Clinical Epidemiology Aarhus University and Aarhus University Hospital Aarhus Denmark

10. Giuseppe Roberto

    Agenzia Regionale di Sanità della Toscana

    Affiliation as printed

    Agenzia Regionale di Sanità della Toscana Florence Italy

11. Miguel Gil

    Agencia Española de Medicamentos y Productos Sanitarios

    Affiliation as printed

    Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria Agencia Española de Medicamentos y Productos Sanitarios Madrid Spain

12. Miguel Angel Maciá

    Agencia Española de Medicamentos y Productos Sanitarios

    Affiliation as printed

    Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria Agencia Española de Medicamentos y Productos Sanitarios Madrid Spain

13. Wiebke Schäfer

    Leibniz Institute for Prevention Research and Epidemiology - BIPS

    Affiliation as printed

    Leibniz Institute for Prevention Research and Epidemiology Bremen Germany

14. Ulrike Haug

    University of Bremen · Leibniz Institute for Prevention Research and Epidemiology - BIPS

    Affiliation as printed

    Faculty of Human and Health Science University of Bremen Bremen Germany

    Leibniz Institute for Prevention Research and Epidemiology Bremen Germany

15. Nicolas H. Thurin

    Université de Bordeaux · Inserm · Centre d'Investigation Clinique Plurithématique de Bordeaux

    Affiliation as printed

    Bordeaux PharmacoEpi INSERM CIC‐P 1401 Université de Bordeaux Bordeaux France

16. R. Lassalle

    Université de Bordeaux · Inserm · Centre d'Investigation Clinique Plurithématique de Bordeaux

    Affiliation as printed

    Bordeaux PharmacoEpi INSERM CIC‐P 1401 Université de Bordeaux Bordeaux France

17. Cécile Droz‐Perroteau

    Université de Bordeaux · Inserm · Centre d'Investigation Clinique Plurithématique de Bordeaux

    Affiliation as printed

    Bordeaux PharmacoEpi INSERM CIC‐P 1401 Université de Bordeaux Bordeaux France

18. Silvia Zaccagnino Aachen

    European Society for Blood and Marrow Transplantation

    Affiliation as printed

    European Society for Blood & Marrow Transplantation Leiden The Netherlands

19. María Paula Busto Aachen

    European Society for Blood and Marrow Transplantation

    Affiliation as printed

    European Society for Blood & Marrow Transplantation Leiden The Netherlands

20. Bas M Middelkoop Aachen

    European Society for Blood and Marrow Transplantation

    Affiliation as printed

    European Society for Blood & Marrow Transplantation Leiden The Netherlands

21. Karin Gembert

    Karolinska Institutet

    Affiliation as printed

    Department of Epidemiology Karolinska Institutet Stockholm Sweden

22. Francisco Sánchez‐Sáez

    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    Affiliation as printed

    Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain

23. Clara Liliana Rodríguez-Bernal

    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    Affiliation as printed

    Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain

24. Gabriel Sanfélix‐Gimeno

    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    Affiliation as printed

    Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain

25. Isabel Hurtado

    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    Affiliation as printed

    Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain

26. Manuel Barreiro‐de Acosta

    Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

    Affiliation as printed

    Spanish Working Group on Crohn's Disease and Ulcerative Colitis Bilbao Spain

27. Beatriz Poblador‐Plou

    Hospital Universitario Miguel Servet · Instituto de Investigación Sanitaria Aragón · Instituto Aragonés de Ciencias de la Salud

    Affiliation as printed

    EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital Zaragoza Spain

28. Jonás Carmona‐Pírez

    Andalusian Health Service · Hospital Universitario Miguel Servet · Instituto de Investigación Sanitaria Aragón · Instituto Aragonés de Ciencias de la Salud

    Affiliation as printed

    EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital Zaragoza Spain

    Technical Advisory Subdirectorate of Information Management (STAGI) Andalusian Health Service (SAS) Seville Spain

29. Antonio Gimeno Miguel

    Hospital Universitario Miguel Servet · Instituto de Investigación Sanitaria Aragón · Instituto Aragonés de Ciencias de la Salud

    Affiliation as printed

    EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital Zaragoza Spain

30. Alexandra Prados‐Torres

    Hospital Universitario Miguel Servet · Instituto de Investigación Sanitaria Aragón · Instituto Aragonés de Ciencias de la Salud

    Affiliation as printed

    EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital Zaragoza Spain

31. Anna Schultze

    London School of Hygiene & Tropical Medicine

    Affiliation as printed

    London School of Hygiene and Tropical Medicine London UK

32. Ron M. C. Herings

    Pharmo Institute

    Affiliation as printed

    PHARMO Institute for Drug Outcomes Research Utrecht The Netherlands

33. Josine Kuiper

    Pharmo Institute

    Affiliation as printed

    PHARMO Institute for Drug Outcomes Research Utrecht The Netherlands

34. Igor Locatelli

    University of Ljubljana

    Affiliation as printed

    Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia

35. Janja Jazbar

    University of Ljubljana

    Affiliation as printed

    Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia

36. Špela Žerovnik

    University of Ljubljana

    Affiliation as printed

    Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia

37. Mitja Kos

    University of Ljubljana

    Affiliation as printed

    Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia

38. Steven Smit

    University of Tartu

    Affiliation as printed

    Institute of Genomics, University of Tartu Tartu Estonia

39. Sirje Lind

    University of Tartu

    Affiliation as printed

    Institute of Genomics, University of Tartu Tartu Estonia

40. Andres Metspalu

    University of Tartu

    Affiliation as printed

    Institute of Genomics, University of Tartu Tartu Estonia

41. Stefania Simou

    European Medicines Agency

    Affiliation as printed

    European Medicines Agency Amsterdam The Netherlands

42. Karin Hedenmalm

    European Medicines Agency

    Affiliation as printed

    European Medicines Agency Amsterdam The Netherlands

43. Ana Cochino

    European Medicines Agency

    Affiliation as printed

    European Medicines Agency Amsterdam The Netherlands

44. Paolo Alcini

    European Medicines Agency

    Affiliation as printed

    European Medicines Agency Amsterdam The Netherlands

45. Xavier Kurz

    European Medicines Agency

    Affiliation as printed

    European Medicines Agency Amsterdam The Netherlands

46. Susana Perez‐Gutthann

    RTI Health Solutions

    Affiliation as printed

    Department of Epidemiology RTI Health Solutions Barcelona Spain