Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe

Gini, Rosa; Pajouheshnia, Romin; Gutierrez, Lia; Swertz, Morris A.; Hyde, Eleanor; Sturkenboom, Miriam; Arana, Alejandro; Franzoni, Carla; Ehrenstein, Vera; Roberto, Giuseppe; Gil, Miguel; Maciá, Miguel Angel; Schäfer, Wiebke; Haug, Ulrike; Thurin, Nicolas H.; Lassalle, Régis; Droz‐Perroteau, Cécile; Zaccagnino, Silvia; Busto, Maria Paula; Middelkoop, Bas; Gembert, Karin; Sanchez‐Saez, Francisco; Rodriguez‐Bernal, Clara; Sanfélix‐Gimeno, Gabriel; Hurtado, Isabel; Acosta, Manuel Barreiro‐de; Poblador‐Plou, Beatriz; Carmona‐Pírez, Jonás; Gimeno‐Miguel, Antonio; Prados‐Torres, Alexandra; Schultze, Anna; Jansen, Ella; Herings, Ron; Kuiper, Josine; Locatelli, Igor; Jazbar, Janja; Žerovnik, Špela; Kos, Mitja; Smit, Steven; Lind, Sirje; Metspalu, Andres; Simou, Stefania; Hedenmalm, Karin; Cochino, Ana; Alcini, Paolo; Kurz, Xavier; Perez‐Gutthann, Susana

doi:10.1002/pds.5884

Pharmacoepidemiology and Drug

2024

DOI: 10.1002/pds.5884

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Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe

Rosa Gini,

Romin Pajouheshnia,

Lia Gutierrez

et al.

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2024

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

Pajouheshnia,

Gini,

Gutierrez

et al. 2024

Pharmacoepidemiology and Drug

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PurposeMetadata 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.

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

Pajouheshnia,

Gini,

Gutierrez

et al. 2024

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

show abstract

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Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe

Cited by 1 publication

References 8 publications

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

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

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