Department of Health Care Administration and Management, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Department of Health Care Administration and Management, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Vaccine. 2023 May 26;41(23):3556-3563. doi: 10.1016/j.vaccine.2023.03.059. Epub 2023 Mar 29.
There are currently no COVID-19 vaccine assessment systems in Japan that allow for the active surveillance of both vaccinated and unvaccinated persons. Herein, we describe the development of Japan's first COVID-19 vaccine effectiveness and safety assessment system with active surveillance capabilities.
The Vaccine Effectiveness, Networking, and Universal Safety (VENUS) Study was developed as a multi-source database that links four data types at the individual resident level: Basic Resident Register (base population information), Vaccination Record System (vaccination-related information), Health Center Real-time Information-sharing System on COVID-19 (HER-SYS; information on COVID-19 occurrence), and health care claims data (information on diagnoses, hospitalizations, diagnostic tests, and treatments). These data were obtained from four municipalities. Individual residents were linked across the data types using five matching algorithms based on names, birth dates, and sex; the data were anonymized after linkage. To ascertain the viability of the VENUS Study's database for COVID-19 vaccine assessments, we examined the trends in COVID-19 vaccinations, COVID-19 cases, and polymerase chain reaction (PCR) test numbers. We also evaluated the linkage rates across the data types.
Our multi-source database was able to monitor COVID-19 vaccinations, COVID-19 cases, and PCR test numbers throughout the pandemic. Using the five algorithms, the data linkage rates between the COVID-19 occurrence information in the HER-SYS and the Basic Resident Register ranged from 85·4% to 91·7%.
If used judiciously with an understanding of each data source's characteristics, the VENUS Study can provide a viable data platform that facilitates active surveillance and comparative analyses for population-based research on COVID-19 vaccine effectiveness and safety in Japan.
目前日本还没有 COVID-19 疫苗评估系统能够对已接种和未接种人群进行主动监测。在此，我们描述了日本首个具有主动监测功能的 COVID-19 疫苗有效性和安全性评估系统的开发情况。
疫苗有效性、网络和通用安全性（VENUS）研究是作为一个多源数据库开发的，该数据库将个体居民层面的四种数据类型联系起来：基本居民登记簿（基本人口信息）、疫苗接种记录系统（与疫苗接种相关的信息）、保健中心 COVID-19 实时信息共享系统（HER-SYS；COVID-19 发生信息）和医疗保健索赔数据（诊断、住院、诊断测试和治疗信息）。这些数据来自四个市。使用基于姓名、出生日期和性别的五种匹配算法，在数据类型之间对个体居民进行链接；链接后对数据进行匿名处理。为了确定 VENUS 研究数据库用于 COVID-19 疫苗评估的可行性，我们检查了 COVID-19 疫苗接种、COVID-19 病例和聚合酶链反应（PCR）测试数量的趋势。我们还评估了各数据类型之间的链接率。
我们的多源数据库能够在整个大流行期间监测 COVID-19 疫苗接种、COVID-19 病例和 PCR 测试数量。使用这五种算法，HER-SYS 中的 COVID-19 发生信息与基本居民登记簿之间的数据链接率在 85.4%至 91.7%之间。
如果明智地使用并了解每个数据源的特点，VENUS 研究可以提供一个可行的数据平台，便于对 COVID-19 疫苗有效性和安全性进行基于人群的研究进行主动监测和比较分析。
