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

被引：0

作者：

Pajouheshnia, Romin ^{[1
,2
]}

Gini, Rosa ^{[3
]}

Gutierrez, Lia ^{[2
]}

Swertz, Morris A. ^{[4
]}

Hyde, Eleanor ^{[4
]}

Sturkenboom, Miriam ^{[5
]}

Arana, Alejandro ^{[2
]}

Franzoni, Carla ^{[2
]}

Ehrenstein, Vera ^{[6
,7
]}

Roberto, Giuseppe ^{[3
]}

Gil, Miguel ^{[8
]}

Macia, Miguel Angel ^{[8
]}

Schaefer, Wiebke ^{[9
]}

Haug, Ulrike ^{[9
,10
]}

Thurin, Nicolas H. ^{[11
]}

Lassalle, Regis ^{[11
]}

Droz-Perroteau, Cecile ^{[11
]}

Zaccagnino, Silvia ^{[12
]}

Busto, Maria Paula ^{[12
]}

Middelkoop, Bas ^{[12
]}

Gembert, Karin ^{[13
]}

Sanchez-Saez, Francisco ^{[14
]}

Rodriguez-Bernal, Clara ^{[14
]}

Sanfelix-Gimeno, Gabriel ^{[14
]}

Hurtado, Isabel ^{[14
]}

Barreiro-de Acosta, Manuel ^{[15
]}

Poblador-Plou, Beatriz ^{[16
]}

Carmona-Pirez, Jonas ^{[16
,17
]}

Gimeno-Miguel, Antonio ^{[16
]}

Prados-Torres, Alexandra ^{[16
]}

Schultze, Anna ^{[18
]}

Jansen, Ella ^{[19
]}

Herings, Ron ^{[19
]}

Kuiper, Josine ^{[19
]}

Locatelli, Igor ^{[20
]}

Jazbar, Janja ^{[20
]}

Zerovnik, Spela ^{[20
]}

Kos, Mitja ^{[20
]}

Smit, Steven ^{[21
]}

Lind, Sirje ^{[21
]}

Metspalu, Andres ^{[21
]}

Simou, Stefania ^{[22
]}

Hedenmalm, Karin ^{[22
]}

Cochino, Ana ^{[22
]}

Alcini, Paolo ^{[22
]}

Kurz, Xavier ^{[22
]}

Perez-Gutthann, Susana ^{[2
]}

机构：

[1] Univ Utrecht, Div Pharmacoepidemiol & Clin Pharmacol, Utrecht, Netherlands

[2] RTI Hlth Solut, Dept Epidemiol, Barcelona, Spain

[3] Agenzia Reg Sanita Toscana, Florence, Italy

[4] Univ Med Ctr Groningen, Dept Genet, Groningen, Netherlands

[5] Univ Med Ctr Utrecht, Utrecht, Netherlands

[6] Aarhus Univ, Dept Clin Epidemiol, Aarhus, Denmark

[7] Aarhus Univ Hosp, Aarhus, Denmark

[8] Agencia Espanola Medicamentos & Prod Sanitarios, Base Datos Invest Farmacoepidemiol Atenc Primaria, Madrid, Spain

[9] Leibniz Inst Prevent Res & Epidemiol, Bremen, Germany

[10] Univ Bremen, Fac Human & Hlth Sci, Bremen, Germany

[11] Univ Bordeaux, INSERM CIC P 1401, Bordeaux PharmacoEpi, Bordeaux, France

[12] European Soc Blood & Marrow Transplantat, Leiden, Netherlands

[13] Karolinska Inst, Dept Epidemiol, Stockholm, Sweden

[14] Fdn Promot Hlth & Biomed Res Valencia Reg, Valencia, Spain

[15] Spanish Working Grp Crohns Dis & Ulcerat Colitis, Bilbao, Spain

[16] Miguel Servet Univ Hosp, Aragon Hlth Sci Inst IACS, EpiChron Res Grp, IIS Aragon, Zaragoza, Spain

[17] Andalusian Hlth Serv SAS, Tech Advisory Subdirectorate Informat Management S, Seville, Spain

[18] London Sch Hyg & Trop Med, London, England

[19] PHARMO Inst Drug Outcomes Res, Utrecht, Netherlands

[20] Univ Ljubljana, Fac Pharm, Ljubljana, Slovenia

[21] Univ Tartu, Inst Genom, Tartu, Estonia

[22] European Med Agcy, Amsterdam, Netherlands

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2024年 / 33卷 / 08期

关键词：

catalogue; FAIR; metadata; observational studies; real-world data sources; reproducibility;

D O I：

暂无

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

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.

引用

页数：12

共 38 条

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