Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe-Reference-Cited by-同舟云学术

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

Published:2024-08 Issue:8 Volume:33 Page:
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiology and Drug

Author:

Pajouheshnia Romin¹²^ORCID,Gini Rosa³^ORCID,Gutierrez Lia²^ORCID,Swertz Morris A.⁴^ORCID,Hyde Eleanor⁴^ORCID,Sturkenboom Miriam⁵^ORCID,Arana Alejandro²^ORCID,Franzoni Carla²^ORCID,Ehrenstein Vera⁶^ORCID,Roberto Giuseppe³^ORCID,Gil Miguel⁷^ORCID,Maciá Miguel Angel⁷^ORCID,Schäfer Wiebke⁸^ORCID,Haug Ulrike⁸⁹^ORCID,Thurin Nicolas H.¹⁰^ORCID,Lassalle Régis¹⁰^ORCID,Droz‐Perroteau Cécile¹⁰^ORCID,Zaccagnino Silvia¹¹^ORCID,Busto Maria Paula¹¹^ORCID,Middelkoop Bas¹¹,Gembert Karin¹²^ORCID,Sanchez‐Saez Francisco¹³^ORCID,Rodriguez‐Bernal Clara¹³^ORCID,Sanfélix‐Gimeno Gabriel¹³^ORCID,Hurtado Isabel¹³^ORCID,Acosta Manuel Barreiro‐de¹⁴^ORCID,Poblador‐Plou Beatriz¹⁵^ORCID,Carmona‐Pírez Jonás¹⁵¹⁶^ORCID,Gimeno‐Miguel Antonio¹⁵^ORCID,Prados‐Torres Alexandra¹⁵^ORCID,Schultze Anna¹⁷^ORCID,Jansen Ella¹⁸^ORCID,Herings Ron¹⁸^ORCID,Kuiper Josine¹⁸^ORCID,Locatelli Igor¹⁹^ORCID,Jazbar Janja¹⁹^ORCID,Žerovnik Špela¹⁹^ORCID,Kos Mitja¹⁹^ORCID,Smit Steven²⁰^ORCID,Lind Sirje²⁰,Metspalu Andres²⁰^ORCID,Simou Stefania²¹,Hedenmalm Karin²¹^ORCID,Cochino Ana²¹^ORCID,Alcini Paolo²¹,Kurz Xavier²¹^ORCID,Perez‐Gutthann Susana²^ORCID

Affiliation:

1. Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht University Utrecht The Netherlands

2. Department of Epidemiology RTI Health Solutions Barcelona Spain

3. Agenzia Regionale di Sanità della Toscana Florence Italy

4. Department of Genetics University Medical Centre Groningen Groningen The Netherlands

5. University Medical Centre Utrecht Utrecht The Netherlands

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

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

8. Leibniz Institute for Prevention Research and Epidemiology Bremen Germany

9. Faculty of Human and Health Science University of Bremen Bremen Germany

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

11. European Society for Blood & Marrow Transplantation Leiden The Netherlands

12. Department of Epidemiology Karolinska Institutet Stockholm Sweden

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

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

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

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

17. London School of Hygiene and Tropical Medicine London UK

18. PHARMO Institute for Drug Outcomes Research Utrecht The Netherlands

19. Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia

20. Institute of Genomics, University of Tartu Tartu Estonia

21. European Medicines Agency Amsterdam The Netherlands

Abstract

ABSTRACTPurposeMetadata 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.MethodsA 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.ResultsA 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.ConclusionsA 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.

Funder

European Medicines Agency

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5871

Reference41 articles.

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1. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe;Pharmacoepidemiology and Drug Safety;2024-08