日本真实世界数据在高血压及其与心血管或肾脏疾病相关性研究中的作用和局限性。

Usefulness and caveats of real-world data for research on hypertension and its association with cardiovascular or renal disease in Japan.

机构信息

Division of Public Health, Hygiene and Epidemiology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.

Department of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University, Sendai, Japan.

出版信息

Hypertens Res. 2024 Nov;47(11):3099-3113. doi: 10.1038/s41440-024-01875-5. Epub 2024 Sep 11.

Abstract

The role of real-world data, collected from clinical practice rather than clinical trials, has become increasingly important for investigating real-life situations, such as treatment effects. In Japan, evidence on hypertension, cardiovascular diseases, and kidney diseases using real-world data is increasing. These studies are mainly based on "the insurer-based real-world data" collected as electronic records, including data from health check-ups and medical claims such as JMDC database, DeSC database, the Japan Health Insurance Association (JHIA) database, or National Databases of Health Insurance Claims and Specific Health Checkups (NDB). Based on the insurer-based real-world data, traditional but finely stratified associations between hypertension and cardiovascular or kidney diseases can be explored. The insurer-based real-world data are also useful for pharmacoepidemiological studies that capture the distribution and trends of drug prescriptions; combined with annual health check-up data, the effectiveness of drugs can also be examined. Despite the usefulness of insurer-based real-world data collected as electronic records from a wide range of populations, we must be cautious about several points, including issues regarding population uncertainty, the validity of cardiovascular outcomes, the accuracy of blood pressure, traceability, and biases, such as indication and immortal biases. While a large sample size is considered a strength of real-world data, we must keep in mind that it does not overcome the problem of systematic error. This review discusses the usefulness and pitfalls of insurer-based real-world data in Japan through recent examples of Japanese research on hypertension and its association with cardiovascular or kidney disease.

摘要

真实世界数据的作用越来越重要,这些数据来自于临床实践,而不是临床试验,可以用于研究真实情况下的治疗效果等。在日本,使用真实世界数据的高血压、心血管疾病和肾脏疾病的证据正在增加。这些研究主要基于“基于保险公司的真实世界数据”,这些数据是通过电子记录收集的,包括健康检查和医疗索赔数据,如 JMDC 数据库、DeSC 数据库、日本健康保险协会(JHIA)数据库或国家医疗保险索赔和特定健康检查数据库(NDB)。基于保险公司的真实世界数据,可以探索高血压与心血管或肾脏疾病之间传统但精细分层的关联。基于保险公司的真实世界数据还可用于药物流行病学研究,以捕捉药物处方的分布和趋势;结合年度健康检查数据,还可以检查药物的有效性。尽管从广泛人群中收集的基于保险公司的真实世界电子记录数据非常有用,但我们必须注意几个问题,包括人群不确定性问题、心血管结局的有效性问题、血压准确性问题、可追溯性问题以及指示性和不朽性偏倚等问题。虽然大样本量被认为是真实世界数据的优势,但我们必须牢记,它并不能克服系统误差问题。本文通过日本高血压及其与心血管或肾脏疾病关联的最新研究实例,讨论了日本基于保险公司的真实世界数据的有用性和潜在问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63e1/11534704/52e671cd7b0a/41440_2024_1875_Fig1_HTML.jpg

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