Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe.
Romin Pajouheshnia, Rosa Gini, Lia Gutierrez, Morris A Swertz, Eleanor Hyde, Miriam Sturkenboom, Alejandro Arana, Carla Franzoni, Vera Ehrenstein, Giuseppe Roberto, Miguel Gil, Miguel Angel Maciá, Wiebke Schäfer, Ulrike Haug, Nicolas H Thurin, Régis Lassalle, Cécile Droz-Perroteau, Silvia Zaccagnino, Maria Paula Busto, Bas Middelkoop, Karin Gembert, Francisco Sanchez-Saez, Clara Rodriguez-Bernal, Gabriel Sanfélix-Gimeno, Isabel Hurtado, Manuel Barreiro-de Acosta, Beatriz Poblador-Plou, Jonás Carmona-Pírez, Antonio Gimeno-Miguel, Alexandra Prados-Torres, Anna Schultze, Ella Jansen, Ron Herings, Josine Kuiper, Igor Locatelli, Janja Jazbar, Špela Žerovnik, Mitja Kos, Steven Smit, Sirje Lind, Andres Metspalu, Stefania Simou, Karin Hedenmalm, Ana Cochino, Paolo Alcini, Xavier Kurz, Susana Perez-Gutthann
{"title":"Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe.","authors":"Romin Pajouheshnia, Rosa Gini, Lia Gutierrez, Morris A Swertz, Eleanor Hyde, Miriam Sturkenboom, Alejandro Arana, Carla Franzoni, Vera Ehrenstein, Giuseppe Roberto, Miguel Gil, Miguel Angel Maciá, Wiebke Schäfer, Ulrike Haug, Nicolas H Thurin, Régis Lassalle, Cécile Droz-Perroteau, Silvia Zaccagnino, Maria Paula Busto, Bas Middelkoop, Karin Gembert, Francisco Sanchez-Saez, Clara Rodriguez-Bernal, Gabriel Sanfélix-Gimeno, Isabel Hurtado, Manuel Barreiro-de Acosta, Beatriz Poblador-Plou, Jonás Carmona-Pírez, Antonio Gimeno-Miguel, Alexandra Prados-Torres, Anna Schultze, Ella Jansen, Ron Herings, Josine Kuiper, Igor Locatelli, Janja Jazbar, Špela Žerovnik, Mitja Kos, Steven Smit, Sirje Lind, Andres Metspalu, Stefania Simou, Karin Hedenmalm, Ana Cochino, Paolo Alcini, Xavier Kurz, Susana Perez-Gutthann","doi":"10.1002/pds.5871","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 8","pages":"e5871"},"PeriodicalIF":2.4000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.5871","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
