在传染病研究中创建标准化常用数据元素用于诊断测试:语义和语法映射
Caroline Stellmach1, Sina Marie Hopff2, Thomas Jaenisch3
1Berlin Institute of Health, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Journal of medical Internet research
|June 10, 2024
概括
在传染病临床研究中标准化诊断测试变量对于数据共享和分析至关重要. 这项研究确定了11个共同数据元素 (CDE),以改善试验中的数据互操作性和可比性.
科学领域:
- 临床研究 临床研究
- 传染性疾病 传染性疾病
- 数据科学数据科学数据科学
背景情况:
- 协调和标准化临床研究中的数据变量,特别是传染病,对于合并和共享患者数据至关重要.
- 公共卫生依赖于传染病研究的及时和可靠的见解,需要从大样本大小获得高质量的数据.
- 实施核心数据元素和互操作性标准有助于创建协调的临床数据集.
研究的目的:
- 来自6项国际传染病临床研究的诊断测试变量进行比较,协调和标准化.
- 为诊断测试建立泛研究的共同数据元素 (CDE).
- 促进正在进行和未来的传染病临床试验的互操作性和数据可比性.
主要方法:
- 从6项传染病研究中的病例报告表 (CRF) 中审查和比较元数据,以确定CDE.
- 检查了国际语义标准代码 (SNOMED CT,NCI Thesaurus,LOINC) 的可用性,以明确表示诊断测试信息.
- 提出了两个数据模型,其中包含了对已识别的CDE的语义和语法标准.
主要成果:
- 从216个分析的变量中确定了11个CDE用于传染病诊断测试.
- 关键的CDE包括病毒系/类,测试日期,类型,执行者,制造商,目标基因,结果 (定量/质量) 和样本细节.
- 语义标准代码被评估为它们的适用性来表示这些CDE.
结论:
- 识别传染病的CDE是迈向数据交换和融合的关键第一步,以便在研究中进行增强分析.
- 通过将数据元素映射到标准术语来实现协调和标准化,以实现明确的解释.
- 采用标准交换格式,如FHIR或CDISC标准,进一步促进数据交换和互操作性.
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