Published in:International Journal of Technology Assessment in Health Care
Language:
English
DOI:
10.1017/s0266462321000301
ISSN:
0266-4623;
1471-6348
Origination:
Footnote:
Description:
<jats:title>Abstract</jats:title>
<jats:sec id="S0266462321000301_sec_a1">
<jats:title>Aim</jats:title>
<jats:p>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?</jats:p>
</jats:sec>
<jats:sec id="S0266462321000301_sec_a2" sec-type="methods">
<jats:title>Methods</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec id="S0266462321000301_sec_a3" sec-type="results">
<jats:title>Results</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec id="S0266462321000301_sec_a4" sec-type="conclusions">
<jats:title>Conclusions</jats:title>
<jats:p>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.</jats:p>
</jats:sec>