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

Pongiglione, Benedetta; Torbica, Aleksandra; Blommestein, Hedwig; de Groot, Saskia; Ciani, Oriana; Walker, Sarah; Dams, Florian; Blankart, Rudolf; Mollenkamp, Meilin; Kovács, Sándor; Tarricone, Rosanna; Drummond, Mike (2021). Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal. International journal of technology assessment in health care, 37(1), e62. Cambridge University Press 10.1017/S0266462321000301

do-existing-real-world-data-sources-generate-suitable-evidence-for-the-hta-of-medical-devices-in-europe-mapping-and-critical-appraisal.pdf - Published Version
Available under License Creative Commons: Attribution (CC-BY).

Download (325kB) | Preview

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?

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.

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.

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.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Faculty Institutions > sitem Center for Translational Medicine and Biomedical Entrepreneurship > Healthcare Regulation and Management
11 Centers of Competence > KPM Center for Public Management

UniBE Contributor:

Blankart, Carl Rudolf Berchtold


300 Social sciences, sociology & anthropology > 350 Public administration & military science
300 Social sciences, sociology & anthropology > 330 Economics
300 Social sciences, sociology & anthropology > 340 Law




Cambridge University Press


[UNSPECIFIED] European Commission Horizon 2020


Projects 779306 not found.




Carl Rudolf Berchtold Blankart

Date Deposited:

15 Jun 2021 17:07

Last Modified:

20 Jun 2021 03:09

Publisher DOI:


PubMed ID:





Actions (login required)

Edit item Edit item
Provide Feedback