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临床研究中的真实世界数据应用:叙述性综述。

Clinical research using real-world data: A narrative review.

机构信息

Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan; Clinical Research Center, NHO Tokyo National Hospital, 3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, Japan.

Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan; Department of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.

出版信息

Respir Investig. 2024 Nov;62(6):929-934. doi: 10.1016/j.resinv.2024.08.002. Epub 2024 Aug 24.

Abstract

Randomized controlled trials (RCTs) and studies using real-world data (RWD) each have their strengths and weaknesses, and can effectively complement each other. When RCTs are not feasible, RWD studies offer a valuable alternative. In this narrative review, we examine several types of RWD studies, focusing on studies utilizing administrative claims databases. These include the Diagnosis Procedure Combination databases, commercially available health checkups and healthcare claims databases (such as the JDMC and DeSC databases), and the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). Given that these claims databases cover different populations, patient settings, variables, and levels of accessibility, it is crucial for researchers to select the most appropriate data source to effectively address their research questions. Additionally, it is desirable for readers of studies using these databases to be aware of their characteristics in order to fully understand the context and limitations of the research findings.

摘要

随机对照试验(RCTs)和使用真实世界数据(RWD)的研究各自具有优势和局限性,可以有效地相互补充。当 RCTs 不可行时,RWD 研究提供了有价值的替代方案。在这篇叙述性综述中,我们考察了几种类型的 RWD 研究,重点关注利用行政索赔数据库的研究。这些研究包括诊断程序组合数据库、商业性健康检查和医疗保健索赔数据库(如 JDMC 和 DESC 数据库),以及日本国民健康保险索赔和特定健康检查数据库(NDB)。鉴于这些索赔数据库涵盖了不同的人群、患者环境、变量和可及性水平,研究人员选择最合适的数据源来有效解决他们的研究问题至关重要。此外,使用这些数据库的研究的读者希望了解它们的特征,以便充分理解研究结果的背景和局限性。

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