TY - JOUR
T1 - Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA)
T2 - Development and Pilot of a Metadata List and Catalogue in Europe
AU - Pajouheshnia, Romin
AU - Gini, Rosa
AU - Gutierrez, Lia
AU - Swertz, Morris A
AU - Hyde, Eleanor
AU - Sturkenboom, Miriam
AU - Arana, Alejandro
AU - Franzoni, Carla
AU - Ehrenstein, Vera
AU - Roberto, Giuseppe
AU - Gil, Miguel
AU - Maciá, Miguel Angel
AU - Schäfer, Wiebke
AU - Haug, Ulrike
AU - Thurin, Nicolas H
AU - Lassalle, Régis
AU - Droz-Perroteau, Cécile
AU - Zaccagnino, Silvia
AU - Busto, Maria Paula
AU - Middelkoop, Bas
AU - Gembert, Karin
AU - Sanchez-Saez, Francisco
AU - Rodriguez-Bernal, Clara
AU - Sanfélix-Gimeno, Gabriel
AU - Hurtado, Isabel
AU - Acosta, Manuel Barreiro de
AU - Poblador-Plou, Beatriz
AU - Carmona-Pírez, Jonás
AU - Gimeno-Miguel, Antonio
AU - Prados-Torres, Alexandra
AU - Schultze, Anna
AU - Jansen, Ella
AU - Herings, Ron
AU - Kuiper, Josine
AU - Locatelli, Igor
AU - Jazbar, Janja
AU - Žerovnik, Špela
AU - Kos, Mitja
AU - Smit, Steven
AU - Lind, Sirje
AU - Metspalu, Andres
AU - Simou, Stefania
AU - Hedenmalm, Karin
AU - Cochino, Ana
AU - Alcini, Paolo
AU - Kurz, Xavier
AU - Perez-Gutthann, Susana
N1 - Publisher Copyright:
© 2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
PY - 2024/8
Y1 - 2024/8
N2 - 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.
AB - 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.
KW - catalogue
KW - FAIR
KW - metadata
KW - observational studies
KW - real-world data sources
KW - reproducibility
UR - http://www.scopus.com/inward/record.url?scp=85201321524&partnerID=8YFLogxK
U2 - 10.1002/pds.5871
DO - 10.1002/pds.5871
M3 - Article
C2 - 39145406
AN - SCOPUS:85201321524
SN - 1053-8569
VL - 33
JO - Pharmacoepidemiology and Drug Safety
JF - Pharmacoepidemiology and Drug Safety
IS - 8
M1 - e5871
ER -