TY - JOUR
T1 - Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal
AU - Pongiglione, Benedetta
AU - Torbica, Aleksandra
AU - Blommestein, Hedwig
AU - De Groot, Saskia
AU - Ciani, Oriana
AU - Walker, Sarah
AU - Dams, Florian
AU - Blankart, Rudolf
AU - Mollenkamp, Meilin
AU - Kovács, Sándor
AU - Tarricone, Rosanna
AU - Drummond, Mike
N1 - Publisher Copyright:
Copyright © The Author(s), 2021. Published by Cambridge University Press.
PY - 2021/4/26
Y1 - 2021/4/26
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85105161288&partnerID=8YFLogxK
U2 - 10.1017/S0266462321000301
DO - 10.1017/S0266462321000301
M3 - Article
C2 - 33896433
AN - SCOPUS:85105161288
SN - 0266-4623
VL - 37
JO - International Journal of Technology Assessment in Health Care
JF - International Journal of Technology Assessment in Health Care
IS - 1
M1 - e62
ER -