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What type of clinical evidence is needed to assess medical devices?
The objective of this mini-review is to discuss the role of real-world studies as a source of clinical evidence when experimental studies, such as randomised controlled trials (RCTs), are not available. Waiting for RCT evidence when the technology is diffusing could be anti-economical, inefficient f...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Respiratory Society
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9487219/ https://www.ncbi.nlm.nih.gov/pubmed/27581825 http://dx.doi.org/10.1183/16000617.0016-2016 |
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author | Tarricone, Rosanna Boscolo, Paola Roberta Armeni, Patrizio |
author_facet | Tarricone, Rosanna Boscolo, Paola Roberta Armeni, Patrizio |
author_sort | Tarricone, Rosanna |
collection | PubMed |
description | The objective of this mini-review is to discuss the role of real-world studies as a source of clinical evidence when experimental studies, such as randomised controlled trials (RCTs), are not available. Waiting for RCT evidence when the technology is diffusing could be anti-economical, inefficient from the policy perspective and methodologically questionable. We explain how real-world studies could provide relevant evidence to decision makers. Matching techniques are discussed as a viable solution for bias reduction. We describe a case study concerning a cost-effectiveness analysis based on real-world data of a technology already in use: Mitraclip combined with medical therapy versus medical therapy alone in patients with moderate-to-severe mitral regurgitation. The CEA has encountered the scepticism of most reviewers, due not to the statistical methodology but to the fact that the study was observational and not experimental. Editors and reviewers converged in considering real-world economic evaluations premature in the absence of a RCT, even if in the meantime the technology had been implanted >30 000 times. We believe there is a need to acknowledge the importance of real-world studies, and engage the scientific community in the promotion and use of clinical evidence produced through observational studies. |
format | Online Article Text |
id | pubmed-9487219 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | European Respiratory Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-94872192022-11-14 What type of clinical evidence is needed to assess medical devices? Tarricone, Rosanna Boscolo, Paola Roberta Armeni, Patrizio Eur Respir Rev Mini-review: Health and Politics The objective of this mini-review is to discuss the role of real-world studies as a source of clinical evidence when experimental studies, such as randomised controlled trials (RCTs), are not available. Waiting for RCT evidence when the technology is diffusing could be anti-economical, inefficient from the policy perspective and methodologically questionable. We explain how real-world studies could provide relevant evidence to decision makers. Matching techniques are discussed as a viable solution for bias reduction. We describe a case study concerning a cost-effectiveness analysis based on real-world data of a technology already in use: Mitraclip combined with medical therapy versus medical therapy alone in patients with moderate-to-severe mitral regurgitation. The CEA has encountered the scepticism of most reviewers, due not to the statistical methodology but to the fact that the study was observational and not experimental. Editors and reviewers converged in considering real-world economic evaluations premature in the absence of a RCT, even if in the meantime the technology had been implanted >30 000 times. We believe there is a need to acknowledge the importance of real-world studies, and engage the scientific community in the promotion and use of clinical evidence produced through observational studies. European Respiratory Society 2016-09 /pmc/articles/PMC9487219/ /pubmed/27581825 http://dx.doi.org/10.1183/16000617.0016-2016 Text en Copyright ©ERS 2016. https://creativecommons.org/licenses/by-nc/4.0/ERR articles are open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. |
spellingShingle | Mini-review: Health and Politics Tarricone, Rosanna Boscolo, Paola Roberta Armeni, Patrizio What type of clinical evidence is needed to assess medical devices? |
title | What type of clinical evidence is needed to assess medical devices? |
title_full | What type of clinical evidence is needed to assess medical devices? |
title_fullStr | What type of clinical evidence is needed to assess medical devices? |
title_full_unstemmed | What type of clinical evidence is needed to assess medical devices? |
title_short | What type of clinical evidence is needed to assess medical devices? |
title_sort | what type of clinical evidence is needed to assess medical devices? |
topic | Mini-review: Health and Politics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9487219/ https://www.ncbi.nlm.nih.gov/pubmed/27581825 http://dx.doi.org/10.1183/16000617.0016-2016 |
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