{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T01:20:39Z","timestamp":1781572839409,"version":"3.54.5"},"reference-count":37,"publisher":"European Respiratory Society (ERS)","issue":"141","content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir Rev"],"accepted":{"date-parts":[[2016,5,7]]},"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:p>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.<\/jats:p><jats:p>We explain how real-world studies could provide relevant evidence to decision makers. Matching techniques are discussed as a viable solution for bias reduction.<\/jats:p><jats:p>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<jats:italic>versus<\/jats:italic>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 &gt;30\u200a000 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.<\/jats:p>","DOI":"10.1183\/16000617.0016-2016","type":"journal-article","created":{"date-parts":[[2016,9,1]],"date-time":"2016-09-01T01:06:50Z","timestamp":1472692010000},"page":"259-265","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":38,"title":["What type of clinical evidence is needed to assess medical devices?"],"prefix":"10.1183","volume":"25","author":[{"given":"Rosanna","family":"Tarricone","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola Roberta","family":"Boscolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrizio","family":"Armeni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2016,8,31]]},"reference":[{"key":"2024102403222147000_25.141.259.1","unstructured":"EUCOMED. The European Medical Technology Industry in Figures. Brussels, MedTech Europe, 2012."},{"key":"2024102403222147000_25.141.259.2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2008.00476_1.x"},{"key":"2024102403222147000_25.141.259.3","doi-asserted-by":"publisher","DOI":"10.1586\/14737167.2014.950233"},{"key":"2024102403222147000_25.141.259.4","doi-asserted-by":"crossref","unstructured":"Buxton MJ . Problems in the economic appraisal of new health technology: the evaluation of heart transplants in the UK. In: Drummond MF. Economic appraisal of health technology in the European community. Oxford, Oxford Medical Publications, 1987; pp. 103\u2013118.","DOI":"10.1007\/978-1-349-18800-0_8"},{"key":"2024102403222147000_25.141.259.5","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2010.0666"},{"key":"2024102403222147000_25.141.259.6","unstructured":"Annemans L , Aristides M , Kubin M . Real-Life Data: A Growing Need. www.ispor.org\/news\/articles\/Oct07\/RLD.asp"},{"key":"2024102403222147000_25.141.259.7","first-page":"467","article-title":"GRACE principles: recognizing high-quality observational studies of comparative effectiveness","volume":"16","author":"Dreyer","year":"2010","journal-title":"Am J Manag Care"},{"key":"2024102403222147000_25.141.259.8","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2009.00602.x"},{"key":"2024102403222147000_25.141.259.9","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2007.00186.x"},{"key":"2024102403222147000_25.141.259.10","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2009.00600.x"},{"key":"2024102403222147000_25.141.259.11","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/70.1.41"},{"key":"2024102403222147000_25.141.259.12","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1198\/000313008X332016","article-title":"Propensity score matching","volume":"62","author":"Peikes","year":"2008","journal-title":"Am Stat"},{"key":"2024102403222147000_25.141.259.13","doi-asserted-by":"publisher","DOI":"10.2307\/2683903"},{"key":"2024102403222147000_25.141.259.14","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2007.07.021"},{"key":"2024102403222147000_25.141.259.15","doi-asserted-by":"publisher","DOI":"10.1002\/sim.3150"},{"key":"2024102403222147000_25.141.259.16","doi-asserted-by":"publisher","DOI":"10.1002\/sim.3245"},{"key":"2024102403222147000_25.141.259.17","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200810488"},{"key":"2024102403222147000_25.141.259.18","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2006.00130.x"},{"key":"2024102403222147000_25.141.259.19","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1093\/aje\/kwj047","article-title":"Results of multivariable logistic regression, propensity matching, propensity adjustment, and propensity-based weighting under conditions of nonuniform effect","volume":"163.3","author":"Kurth","year":"2006","journal-title":"Am J Epidemiol"},{"key":"2024102403222147000_25.141.259.20","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/70.1.41"},{"key":"2024102403222147000_25.141.259.21","doi-asserted-by":"publisher","DOI":"10.1162\/003465302317331982"},{"key":"2024102403222147000_25.141.259.22","doi-asserted-by":"publisher","DOI":"10.1198\/000313008X332016"},{"key":"2024102403222147000_25.141.259.23","first-page":"69","article-title":"Do different clinical evidence bases lead to discordant health-technology assessment decisions? An in-depth case series across three jurisdictions","volume":"5","author":"Spinner","year":"2013","journal-title":"Clinicoecon Outcomes Res"},{"key":"2024102403222147000_25.141.259.24","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehs114"},{"key":"2024102403222147000_25.141.259.25","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.004062"},{"key":"2024102403222147000_25.141.259.26","unstructured":"Abbot Vascular. Percutaneous mitral valve repair with the Mitraclip clip delivery system in high surgical risk patients. www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/MedicalDevices\/MedicalDevicesAdvisoryCommittee\/CirculatorySystemDevicesPanel\/UCM343684.pdf Date last accessed: May 7, 2016."},{"key":"2024102403222147000_25.141.259.27","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.08.067"},{"key":"2024102403222147000_25.141.259.28","doi-asserted-by":"publisher","DOI":"10.3111\/13696998.2013.834823"},{"key":"2024102403222147000_25.141.259.29","unstructured":"NHS Commissioning Board. Clinical Commissioning Policy Statement: Percutaneous mitral valve leaflet repair for mitral regurgitation. www.england.nhs.uk\/commissioning\/wp-content\/uploads\/sites\/12\/2013\/09\/a09-ps-b.pdf Date last accessed: May 29, 2016."},{"key":"2024102403222147000_25.141.259.30","unstructured":"Ludwig Boltzmann Institute. Perkutane Mitralklappenintervention mittels Mitralclip bei Mitralklappeninsuffizienz [Percutaneous mitral valve intervention device Mitralclip for mitral valve insufficiency]. http:\/\/eprints.hta.lbg.ac.at\/967\/1\/DSD_41_Update2012.pdf Date last accessed: May 7, 2016."},{"key":"2024102403222147000_25.141.259.31","unstructured":"Osteba. MitraClip\u00ae para la reparaci\u00f3n del reflujo de la v\u00e1lvula mitral: informes de evaluaci\u00f3n de tecnolog\u00edas sanitarias [MitraClip\u00ae for repair of mitral valve regurgitation: health technology assessment information]. www.osakidetza.euskadi.eus\/contenidos\/informacion\/2014_osteba_publicacion\/es_def\/adjuntos\/MitraClip.pdf Date last accessed: May 7, 2016."},{"key":"2024102403222147000_25.141.259.32","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2016.01.212"},{"key":"2024102403222147000_25.141.259.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2011.05.006"},{"key":"2024102403222147000_25.141.259.34","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhle1113918"},{"key":"2024102403222147000_25.141.259.35","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(13)70178-5"},{"key":"2024102403222147000_25.141.259.36","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2014.4193"},{"key":"2024102403222147000_25.141.259.37","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d6498"}],"container-title":["European Respiratory Review"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1183\/16000617.0016-2016","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T04:58:54Z","timestamp":1740373134000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.ersnet.org\/lookup\/doi\/10.1183\/16000617.0016-2016"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,8,31]]},"references-count":37,"journal-issue":{"issue":"141","published-online":{"date-parts":[[2016,8,31]]},"published-print":{"date-parts":[[2016,9]]}},"alternative-id":["10.1183\/16000617.0016-2016"],"URL":"https:\/\/doi.org\/10.1183\/16000617.0016-2016","relation":{},"ISSN":["0905-9180","1600-0617"],"issn-type":[{"value":"0905-9180","type":"print"},{"value":"1600-0617","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,8,31]]}}}