将临床试验元素嵌入临床实践:试验设计者和实施者的经验.
Carrie Dombeck1,2, Teresa Swezey1,2, Lindsay Kehoe1
1Clinical Trials Transformation Initiative, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Journal of clinical and translational science
|December 10, 2024
概括
将临床试验纳入常规护理需要解决工作人员的时间,买入和数据挑战. 解决方案包括尽量减少患者负担,并促进文化变革,以实现高效的研究和护理整合.
科学领域:
- 临床研究方法论临床研究方法论
- 医疗服务研究 医疗服务研究
背景情况:
- 利用常规临床数据可以增强研究和患者护理.
- 将临床试验纳入实践,通过减少重复,提高了效率.
- 文化,行政和数据障碍阻碍了整合.
研究的目的:
- 探索将干预性随机试验纳入临床实践的动机.
- 确定实施嵌入式试验的障碍和解决方案.
主要方法:
- 与18名试验设计者和实施者进行了16次深入访谈 (IDI).
- 通过应用主题分析分析了采访数据.
主要成果:
- 动机包括建立学习健康系统和现实世界试验评估.
- 主要障碍:员工时间有限,缺乏买入,以及电子健康记录数据问题.
- 建议的解决方案:尽量减少患者/设置负担,确保数据基础设施,并促进文化变革.
结论:
- 结果为嵌入式试验提供了临床试验转型倡议 (CTTI) 的建议.
- 建议侧重于重新考虑试验设计和进行研究和护理协调.
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