Institute of Health Data Infrastructure for All, Tokyo, 104-0061, Japan.
Hypertens Res. 2021 Feb;44(2):147-153. doi: 10.1038/s41440-020-00580-3. Epub 2020 Nov 30.
Big data has been a hot topic in medical and healthcare research. Big data in healthcare is considered to comprise massive amounts of information from various sources, including electronic health records (EHRs), administrative or claims data, and data from self-monitoring devices. Biomedical research has also generated a significant portion of big data relevant to healthcare. Other large datasets arise from cohorts that are recruited and followed on the basis of specific questions, although such research questions may later be expanded to enable other investigations. While the availability of big data offers many possibilities for an improved understanding of disease and treatment, the need for careful and productive use of statistical concepts should be kept in mind. Patient data routinely collected via electronic means are called real-world data (RWD) and are becoming common in healthcare research. RWD and big data are not synonymous with each other, but the two terms seem to be used without distinction with respect to observational studies. In this article, we review hypertension-related papers that use big data or RWD. There are many other sources of big data or RWD that are not covered here, each of which may pose special challenges and opportunities. While randomized clinical trials (RCTs) are considered to be the criterion standard for generating clinical evidence, the use of real-world evidence (RWE) to evaluate the efficacy and safety of medical interventions is gaining interest. On-going efforts to make use of RWD to generate RWE for regulatory decisions, as well as the challenges confronted, including reliability (quality) and relevance (fitness for purpose) of data, will also be addressed.
大数据一直是医学和医疗保健研究的热门话题。医疗保健中的大数据被认为包括来自各种来源的大量信息，包括电子健康记录 (EHR)、行政或索赔数据以及来自自我监测设备的数据。生物医学研究也产生了大量与医疗保健相关的大数据。其他大型数据集来自根据特定问题招募和跟踪的队列，尽管此类研究问题以后可能会扩展以进行其他调查。虽然大数据的可用性为更好地了解疾病和治疗提供了许多可能性，但应牢记谨慎和有效地使用统计概念的必要性。通过电子方式常规收集的患者数据称为真实世界数据 (RWD)，并在医疗保健研究中越来越常见。RWD 和大数据不是同义词，但这两个术语在观察性研究中似乎没有区别地使用。在本文中，我们回顾了使用大数据或 RWD 的与高血压相关的论文。这里没有涵盖许多其他来源的大数据或 RWD，其中每一个都可能带来特殊的挑战和机遇。虽然随机对照试验 (RCT) 被认为是产生临床证据的标准，但使用真实世界证据 (RWE) 来评估医疗干预措施的疗效和安全性越来越受到关注。正在努力利用 RWD 为监管决策生成 RWE，以及所面临的挑战，包括数据的可靠性（质量）和相关性（适合目的），也将得到解决。
