综合电子健康记录工具,以访问瘤学研究中的真实数据
Michelle Casagni1, Nicole Llewellyn2, Maeve Kokolus2
1Clinical Quality and Data Science, The MITRE Corporation, Tampa, FL 33609, United States.
JAMIA open
|December 12, 2024
概括
ICAREdata项目表明,电子健康记录数据可以标准化并用于临床研究. 这证明了在试验中使用数据标准用于现实世界的数据捕获和传输的可行性.
科学领域:
- 医疗信息学 医疗信息学
- 临床研究信息学 临床研究信息学
- 医疗保健中的数据标准
背景情况:
- 电子健康记录 (EHR) 包含用于临床研究的宝贵数据.
- 标准化瘤学结果数据对于高效的研究至关重要.
- 整合临床试验和现实世界终点 (ICAREdata) 项目解决了这些需求.
研究的目的:
- 为了证明提取和传输用于临床研究的标准化EHR数据的可行性.
- 通过社会技术模型评估数据收集和传输的技术实施情况.
- 为未来的举措提供建议,利用现实世界数据 (RWD) 标准.
主要方法:
- 在EHR中实施了用于结构化临床结果数据收集的工具.
- 提取和传输的数据使用最小的常见瘤数据元素 (mCODE) 标准格式化.
- 评估了社会技术模型的8个维度的技术实施情况.
主要成果:
- 成功证明了在临床试验中使用数据标准用于结构化数据捕获和传输的可行性.
- 确定了挑战,并为未来的项目制定了可行的建议.
- 收集了来自10个临床场所和15个试验的标准化瘤结局数据.
结论:
- ICAREdata项目成功验证了用于RWD捕获和传输的数据标准的使用.
- 学到的经验教训可以加速类似举措的成功.
- 为改善获得高质量,标准化RWD的研究和患者护理铺平了道路.
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