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dc.contributor.authorSerrano Aguilar, Pedro
dc.contributor.authorGutiérrez Ibarlucea, Iñaki
dc.contributor.authorDíaz, Pilar
dc.contributor.authorImaz Iglesia, Iñaki
dc.contributor.authorGonzález Enríquez, Jesús
dc.contributor.authorCastro, José Luis
dc.contributor.authorEspallargues Carreras, Mireia
dc.contributor.authorGarcía Armesto, Sandra
dc.contributor.authorArriola Bolado, Paloma
dc.contributor.authorRivero Santana, Amado
dc.contributor.authorPerestelo Pérez, Lilisbeth
dc.contributor.authorGonzález Pacheco, Himar
dc.contributor.authorÁlvarez Pérez, Yolanda
dc.contributor.authorFaraldo Vallés, María José
dc.contributor.authorPUÑAL RIOBOO, JANET 
dc.contributor.authorRamallo-Fariña, Yolanda
dc.contributor.authorSánchez-Gómez, Luis María
dc.contributor.authorAsua-Batarrita, José
dc.contributor.authorReviriego-Rodrigo, Eva
dc.contributor.authorMoreno-Rodríguez, Anai
dc.contributor.authorJuárez-Rojo, Celia
dc.contributor.authorVicente-Saiz, Marisa
dc.contributor.authorOrejas-Pérez, Eugenia
dc.contributor.authorKnabe-Guerra, Jutta
dc.contributor.authorPrieto-Yerro, Isabel
dc.contributor.authorGonzález del Yerro-Valdés, Cristina
dc.date.accessioned2021-05-05T09:22:35Z
dc.date.available2021-05-05T09:22:35Z
dc.date.issued2021
dc.identifier.otherhttps://pubmed.ncbi.nlm.nih.gov/33942712/es
dc.identifier.urihttp://hdl.handle.net/20.500.11940/14801
dc.description.abstractThe Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.es
dc.language.isoenges
dc.rightsAtribución-NoComercial-CompartirIgual 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/4.0/*
dc.subject.meshDecision Making*
dc.titlePostlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision makinges
dc.typeArtigoes
dc.identifier.pmid33942712
dc.issue.number1es
dc.journal.titleInternational Journal of Technology Assessment in Health Carees
dc.organizationServizo Galego de Saúde::Xerencia do Servizo Galego de Saúde::Axencia Galega para a Xestión do Coñecemento en Saúdees
dc.page.initiale63es
dc.relation.publisherversionhttps://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-care/article/postlaunch-evidencegeneration-studies-for-medical-devices-in-spain-the-redets-approach-to-integrate-realworld-evidence-into-decision-making/A705E811A6EEF5865100588156A95E7Ces
dc.rights.accessRightsopenAccesses
dc.subject.decstoma de decisión*
dc.subject.keywordAvalia-tes
dc.subject.keywordRedETSes
dc.typefidesArtigo Científico (inclue Orixinal, Orixinal breve, Revisión Sistemática e Meta-análisis)es
dc.typesophosArtículo Originales
dc.volume.number37es


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Atribución-NoComercial-CompartirIgual 4.0 Internacional
Except where otherwise noted, this item's license is described as Atribución-NoComercial-CompartirIgual 4.0 Internacional