在临床试验参与的背景下,患者自主权和共享决策
Fabio Dennstädt1,2, Paul Martin Putora1,2, Thomas Iseli1
1Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
European journal of clinical investigation
|August 1, 2024
概括
共享决策 (SDM) 通过增强患者自主性和参与,改善临床试验招聘. 试验重新设计和沟通培训等解决方案有助于整合SDM,推进基于证据的医学.
科学领域:
- 临床试验 临床试验
- 患者招募 患者招募
- 共享决策 - - 分享决策
背景情况:
- 临床试验面临的招聘挑战影响研究进展.
- 患者的参与和自主性对于成功参与试验至关重要.
- 共享决策 (SDM) 提供了一个潜在的框架来解决这些问题.
研究的目的:
- 探索SDM如何克服临床试验招聘挑战.
- 检查SDM在调整试验与患者偏好并提高参与度方面的作用.
- 识别和提出解决SDM和试验方法之间的冲突的解决方案.
主要方法:
- 关于患者招募和SDM的综合文献综述.
- 分析案例研究和试验报告,以确定障碍和SDM有效性.
- 建议解决方案的评估:试验设计,沟通培训和决策辅助工具.
主要成果:
- 通过促进自主性和参与,SDM显著提高了患者招募率.
- 医生沟通得到改善,使试验与患者偏好保持一致,并减少障碍.
- 在SDM和试验元素之间存在潜在的冲突,例如随机化和盲目化.
结论:
- 通过SDM获得患者自主权可能与传统的试验方法相冲突.
- 解决方案包括试验重新设计,医生沟通培训和患者决策辅助工具.
- SDM的有效整合支持临床试验和基于证据的医学.
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