瘤学真实世界数据质量框架 时间到治疗 终止 使用案例:实施和评估 研究研究
Boshu Ru1, Arthur Sillah1, Kaushal Desai1
1Center for Observational and Real-world Evidence (CORE), Merck & Co, Inc, West Point, PA, United States.
JMIR medical informatics
|March 6, 2024
概括
评估现实世界的数据质量对于瘤学研究至关重要. 这项研究发现两个数据集之间存在显著的数据质量差异,这影响了实时治疗终止时间 (rwTTD) 估计的可靠性.
科学领域:
- 瘤学研究成果研究结果
- 在健康信息学中的现实世界证据 (RWE)
- 数据质量评估方法 数据质量评估方法
背景情况:
- 现实世界的证据 (RWE) 对于观察性瘤学研究至关重要.
- 分碎的医疗IT系统给数据质量和互操作性带来了挑战.
- 系统的数据质量评估对于使用真实世界数据 (RWD) 的可靠瘤结果研究至关重要.
研究的目的:
- 作为一种新型使用案例,实施现实世界暂停治疗的时间 (rwTTD).
- 使用RWD的使用案例特定相关性和质量评估框架.
- 评估数据质量和适用于瘤学适合目的RWD的相关性.
主要方法:
- 从瘤电子健康记录中映射rwTTD到RWD元素的操作定义.
- 定义了20个任务,以评估SACT使用数据的完整性和可信性,治疗线 (LOT),死亡日期和随访时间.
- 应用用例特定相关性和质量评估对两个瘤学数据库进行评估,以估计晚期头癌患者的rwTTD.
主要成果:
- 数据集A显示对估计rwTTD的相关性更高 (24.96%对5.92%接收目标SACT).
- 在SACT药物术语,LOT格式和数据集之间的分布中观察到的差异.
- 数据集B显示较差的数据完整性,数据滞后和死亡率数据,表明不适合RWTTD估计.
结论:
- 适合目的的数据质量评估显示,RWD集之间存在显著的变化.
- 已建立的rwTTD数据质量规范可以适应各种瘤学用例.
- 强调在现实世界瘤研究中需要严格的数据质量检查.
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