Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal

Benedetta Pongiglione*, Aleksandra Torbica, Hedwig Blommestein, Saskia De Groot, Oriana Ciani, Sarah Walker, Florian Dams, Rudolf Blankart, Meilin Mollenkamp, Sándor Kovács, Rosanna Tarricone, Mike Drummond

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

16 Citations (Scopus)
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Aim Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision making on medical technologies. A useful question is: To what extent are RWD suitable for generating RWE? Methods We mapped existing RWD sources in Europe for three case studies: hip and knee arthroplasty, transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR), and robotic surgery procedures. We provided a comprehensive assessment of their content and appropriateness for conducting the HTA of medical devices. The identification of RWD sources was performed combining a systematic search on PubMed with gray literature scoping, covering fifteen European countries. Results We identified seventy-one RWD sources on arthroplasties; ninety-five on TAVI and TMVR; and seventy-seven on robotic procedures. The number, content, and integrity of the sources varied dramatically across countries. Most sources included at least one health outcome (97.5%), with mortality and rehospitalization/reoperation the most common; 80% of sources included resource outcomes, with length of stay the most common, and comparators were available in almost 70% of sources. Conclusions RWD sources bear the potential for the HTA of medical devices. The main challenges are data accessibility, a lack of standardization of health and economic outcomes, and inadequate comparators. These findings are crucial to enabling the incorporation of RWD into decision making and represent a readily available tool for getting acquainted with existing information sources.

Original languageEnglish
Article numbere62
JournalInternational Journal of Technology Assessment in Health Care
Issue number1
Publication statusPublished - 26 Apr 2021

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Copyright © The Author(s), 2021. Published by Cambridge University Press.


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