Manetti Stefania, Guidotti Elisa, Vola Federico, Vainieri Milena
Department of Management Engineering, Politecnico di Milano, Milan, Italy.
London In-Vitro Diagnostic (IVD) Cooperative, Department of Surgery and Cancer, Imperial College London, London, UK.
Health Econ Policy Law. 2025 Jan 13:1-33. doi: 10.1017/S1744133124000148.
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.
越来越多地使用真实世界证据（RWE）和真实世界数据（RWD）来评估上市后医疗器械（MD），可能满足对数据共享和可追溯性的迫切需求。本研究旨在：（i）概述在报告RWE/RWD的MD上市后评估中的当前实践；（ii）为政府和卫生组织提出政策建议，并为学者确定研究议程。遵循PRISMA指南进行了一项系统综述，直至2024年2月。纳入了以英文撰写的、将RWE/RWD纳入MD任何类型上市后评估策略的原创同行评审文章，并手动检查其参考文献列表。采用叙述性综合来描述检索到的证据。总共确定了145篇研究文章。大多利用行政数据库；在短/中期收集的临床和/或经济证据报告最为频繁；其他证据类型（如组织方面）报告不足；很少纳入患者观点；MD的创新复杂性相对较低。据我们所知，本研究是同类研究中首次全面描述在评估实际使用中的MD时非随机证据的使用情况。本综述的意义可能有助于卫生政策学者探讨MD的RWE研究途径，也有助于政策制定者更好地理解MD在临床实践中长期使用的风险和益处，并在采用和使用方面做出更明智的决策。
