Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milano, Italy.
Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands.
Int J Technol Assess Health Care. 2021 Apr 26;37(1):e62. doi: 10.1017/S0266462321000301.
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?
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.
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.
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.
技术和计算的进步为真实世界数据（RWD）的收集和分析提供了新的工具。考虑到为收集 RWD 而投入的大量精力和资源，如果能够有效地利用真实世界证据（RWE）来支持医疗技术的健康技术评估（HTA）和决策，将会获得更大的回报。一个有用的问题是：RWD 在多大程度上适合产生 RWE？
我们对欧洲的三个案例研究（髋关节和膝关节置换术、经导管主动脉瓣植入术（TAVI）和二尖瓣修复术（TMVR）以及机器人手术程序）中的现有 RWD 来源进行了映射。我们对其内容进行了全面评估，并评估了其对医疗器械 HTA 的适宜性。通过在 PubMed 上进行系统搜索并结合灰色文献范围界定，对 RWD 来源进行了识别，涵盖了十五个欧洲国家。
我们在关节置换术方面确定了 71 个 RWD 来源；在 TAVI 和 TMVR 方面有 95 个来源；在机器人手术方面有 77 个来源。各国的来源数量、内容和完整性差异很大。大多数来源至少包含一个健康结果（97.5%），其中死亡率和再住院/再手术最为常见；80%的来源包含资源结果，其中住院时间最长，几乎 70%的来源有可比物。
RWD 来源具有进行医疗器械 HTA 的潜力。主要挑战是数据可访问性、健康和经济结果缺乏标准化以及可比物不足。这些发现对于实现将 RWD 纳入决策至关重要，并代表了一种现成的工具，可以用来熟悉现有的信息来源。
