评估是否准备好在临床试验中使用电子健康记录数据来确定结果 - 一个案例研究
Denise Esserman1, Erich J Greene1, Nancy K Latham2
1Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
Contemporary clinical trials
|May 13, 2024
概括
一个新的检查清单可以帮助临床试验场所评估电子健康记录 (EHR) 数据质量和基础设施准备情况. 这确保了使用EHR数据进行多站点研究的可靠和公正的数据采集.
科学领域:
- 临床试验 临床试验
- 医疗信息学 医疗信息学
- 数据质量管理数据质量管理
背景情况:
- 可变电子健康记录 (EHR) 数据质量挑战了多地点临床试验结果.
- 不一致的EHR平台和跨站点数据的全面性会影响结果的有效性.
- 确保数据有效性需要一个结构化的方法来克服这些挑战.
研究的目的:
- 提出一个框架和检查清单,以评估临床场所对EHR数据贡献的准备.
- 提高在多个地点的临床试验中使用的EHR数据的质量和一致性.
- 为研究人员提供指导,以确保对临床试验结果进行可靠的数据采集.
主要方法:
- 根据STRIDE研究的经验 (5451名参与者,86个实践,10个医疗保健系统) 开发了一个现场准备清单.
- 检查清单评估了站点基础设施,数据质量和采购成本.
- 强调了解数据捕获,集成和建立数据采购协议.
主要成果:
- 该清单评估了医疗保健系统的基础设施,数据质量和相关成本.
- 它强调了了解网站网络中的数据流的必要性.
- 对于跨站点的一致数据提取的协议至关重要.
结论:
- 在进行多地点试验之前,建议对临床场所数据质量和基础设施进行严格的前性审查.
- 拟议的检查清单有助于调查人员确保可靠和公正的数据采集.
- 该工具支持依赖EHR数据的临床试验的完整性.
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