Tonegawa-Kuji Reina, Kanaoka Koshiro, Iwanaga Yoshitaka
Department of Medical and Health Information Management, National Cerebral and Cardiovascular Center, Suita, Japan.
Department of Medical and Health Information Management, National Cerebral and Cardiovascular Center, Suita, Japan.
J Cardiol. 2023 Mar;81(3):307-315. doi: 10.1016/j.jjcc.2022.09.006. Epub 2022 Sep 17.
Real-world data (RWD) are observational data obtained by collecting, structuring, and accumulating patient information among the medical big data. RWD are derived from a variety of patient medical care and health information outside of conventional research data, and include electronic health records, claims data, registry data of disease, drug and device, health check-up data, and more recently, patient information data from wearable devices. They are currently being utilized in various forms for optimal medical care and real-world evidence (RWE) is constructed through a process of hypothesis generation and verification based on the RWD research. Together with classic clinical research and pragmatic trials, RWE shapes the learning healthcare system and contributes to the improvement of medical care. In the cardiovascular medical care of the current super-aged society, the need for a variety of RWE and the research is increasing, since the guidelines established over time and the medical care based on it cannot necessarily be the best in accordance with the current medical situation. In this review, we focus on the RWD and RWE studies in the cardiovascular medical field and outlines their current status in Japan. Furthermore, we discuss the potential for extending the studies and issues related to the use of medical big data and RWD.
真实世界数据（RWD）是通过在医学大数据中收集、整理和积累患者信息而获得的观察性数据。RWD源自常规研究数据之外的各种患者医疗保健和健康信息，包括电子健康记录、理赔数据、疾病、药物和设备登记数据、健康检查数据，以及最近来自可穿戴设备的患者信息数据。目前，它们正以各种形式被用于优化医疗保健，并通过基于RWD研究的假设生成和验证过程构建真实世界证据（RWE）。RWE与经典临床研究和实用试验一起，塑造了学习型医疗保健系统，并有助于改善医疗保健。在当前超老龄化社会的心血管医疗保健中，由于随着时间推移制定的指南以及基于该指南的医疗保健不一定符合当前医疗状况，因此对各种RWE及其研究的需求正在增加。在本综述中，我们重点关注心血管医学领域的RWD和RWE研究，并概述它们在日本的现状。此外，我们讨论了扩展这些研究的潜力以及与医学大数据和RWD使用相关的问题。
