A systematic literature review of real-world evidence (RWE) on post-market assessment of medical devices.

IF 3 3区 医学 Q2 HEALTH POLICY & SERVICES Health Economics Policy and Law Pub Date : 2025-01-13 DOI:10.1017/S1744133124000148
Stefania Manetti, Elisa Guidotti, Federico Vola, Milena Vainieri
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引用次数: 0

Abstract

The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market medical devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to (i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; (ii) draw policy recommendations for governments and health organisations and identify a research agenda for scholars.A systematic review was undertaken until February 2024 following the PRISMA guidelines. Original peer-reviewed articles in English and incorporating RWE/RWD into any sort of post-market assessment strategy for an MD were included and their reference lists manually checked. A narrative synthesis was employed to describe evidence retrieved.Totally, 145 research articles were identified. Administrative databases were mostly utilised; clinical and/or economic evidence gathered in a short/medium time horizon the most frequently reported; other evidence types (e.g., organisational) underreported; patient perspectives rarely incorporated; the innovation complexity of MDs relatively low.To our knowledge, this study is the first in its kind to provide a comprehensive picture of how non-randomised evidence has been used when assessing MDs working in real-life conditions. The implications of this review might help health policy scholars in addressing the avenues for research in RWE for MDs and policy-makers to better understand the risks and benefits of medium and long-term use of MDs alongside clinical practice and make more informed decisions about adoption and use.

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来源期刊
Health Economics Policy and Law
Health Economics Policy and Law HEALTH POLICY & SERVICES-
CiteScore
5.30
自引率
0.00%
发文量
55
期刊介绍: International trends highlight the confluence of economics, politics and legal considerations in the health policy process. Health Economics, Policy and Law serves as a forum for scholarship on health policy issues from these perspectives, and is of use to academics, policy makers and health care managers and professionals. HEPL is international in scope, publishes both theoretical and applied work, and contains articles on all aspects of health policy. Considerable emphasis is placed on rigorous conceptual development and analysis, and on the presentation of empirical evidence that is relevant to the policy process.
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