使用临床数据交换标准联盟 (CDISC) 研究数据表格模型整合现有队列研究数据的实用方法:REDCap2SDTM的实际使用
Keiichi Matsuzaki1,2, Megumi Kitayama3, Keiichi Yamamoto4
1Department of Public Health, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, JP.
JMIR medical informatics
|September 28, 2023
概括
本研究提出了一个实用的模型,用于整合使用临床数据交换标准联盟 (CDISC) 研究数据表格模型 (SDTM) 的遗留数据库. 开发的方法成功地将三个独立的数据库集成到统一的SDTM格式中.
科学领域:
- 数据管理数据管理
- 临床信息学是一种临床信息学.
- 数据库集成数据库集成
背景情况:
- 遗留数据的利用正在增加,但尚未建立用于不同目的集成现有数据库的方法.
- 之前的工作开发了一个工具,用于从假设的临床试验数据中生成研究数据表格模型 (SDTM) 数据.
- 临床数据交换标准联盟 (CDISC) SDTM是临床数据管理的一个关键标准.
研究的目的:
- 设计和演示用于集成多个现有数据库的实用模型.
- 利用CDISC SDTM协调来自不同来源的数据.
- 建立在聚合分析中使用旧数据的方法.
主要方法:
- 数据集成涉及三个阶段:变量确认,SDTM映射和SDTM数据生成.
- 使用REDCap字段注释嵌入基于CDISC SDTM的元数据 (域名,变量名称,测试代码).
- 使用REDCap2SDTM v2工具以ODM格式生成映射SDTM数据.
主要成果:
- SDTM数据已成功生成为七个元数据定义域的CSV文件.
- 在三个独立存在的数据库中映射了22个常见变量.
- 我们成功地将三个现有数据库集成到一个CDISC SDTM格式的数据库中.
结论:
- CDISC SDTM是整合多个现有数据库的宝贵工具.
- 拟议的模型为传统数据协调提供了一种实际方法.
- 这种方法促进了聚合分析,并提高了现有研究数据的实用性.
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