在多发性硬化病注册和队列中引入真实数据的核心数据集:全球工作组的建议
Tina Parciak1,2,3, Lotte Geys1,2,3, Anne Helme4
1University MS Center (UMSC), Hasselt-Pelt, Belgium.
概括
为多发性硬化症 (MS) 的现实世界数据 (RWD) 开发了一个标准化的核心数据集. 这一数据集促进了各成员国注册表和研究倡议之间的数据协调,改善了合作.
科学领域:
- 神经学 神经学
- 数据科学数据科学数据科学
- 流行病学 流行病学
背景情况:
- 截至2022年9月,对于多发性硬化症 (MS) 的医疗保健和研究,没有标准化的核心数据元素.
- 这种缺乏标准化限制了跨观测数据源的数据协调,并阻碍了科学合作.
研究的目的:
- 建立并就多发性硬化症 (MS) 现实世界数据 (RWD) 的核心数据集达成共识.
- 这一数据集旨在用于观测登记册和队列.
主要方法:
- 采用了三个阶段的过程,包括园林修.
- 在一个由20名多发症和RWD专家组成的全球多利益相关者工作组中,举行了专门的讨论.
主要成果:
- 定义了MS的核心数据集,包括八个类别的44个变量.
- 该数据集包括人口统计,并发症,病史,病情,复发,MRI和治疗数据,并以数据字典的形式发布.
结论:
- 国家数据联盟核心数据集为新注册提供了指导,并加强了跨倡议的协调.
- 通过高效,专家驱动的过程,成功地定义了MS RWD的简洁有效的核心数据集.
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