Benedetta Pongiglione1, Aleksandra Torbica1, Hedwig Blommestein2, Saskia de Groot2, Oriana Ciani1,3, Sarah Walker4, Florian Dams5, Rudolf Blankart5,6, Meilin Mollenkamp7, Sándor Kovács8, Rosanna Tarricone1, Mike Drummond9. 1. Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milano, Italy. 2. Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands. 3. College of Medicine and Health, Institute of Health Research, University of Exeter, Exeter, UK. 4. Exeter University, Exeter, UK. 5. KPM Center for Public Management, University of Bern, Bern, Switzerland. 6. sitem-insel AG, Swiss Institute for Translational and Entrepreneurial Medicine, Bern, Switzerland. 7. Hamburg Center for Health Economics, Universität Hamburg, Hamburg, Germany. 8. Syreon Research Institute, Budapest, Hungary. 9. Centre for Health Economics, University of York, York, UK.
Abstract
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.
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.
Entities:
Keywords:
Economic evaluations; Health Technology Assessment; Medical device; Real-world data; Real-world evidence
Authors: Eulalie Courcelles; Jean-Pierre Boissel; Jacques Massol; Ingrid Klingmann; Riad Kahoul; Marc Hommel; Emmanuel Pham; Alexander Kulesza Journal: Front Med Technol Date: 2022-02-24