基于偏好的受控设计:提高心血管临床试验的患者参与度,效率和外部有效性
Bjorn Redfors1, Sigrid Sandner2, Judy Zhong3
1Department of Population Health Sciences, Weill Cornell Medicine, New York, New York, USA; Department of Molecular and Clinical Medicine, Gothenburg University, Gothenburg, Sweden; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg University, Gothenburg, Sweden.
患者偏好控制试验通过让患者参与治疗分配来改善临床研究. 这提高了招聘和通用性,同时在管理混因素时保持有效的结果.
科学领域:
- 临床试验方法论 临床试验方法论
- 心血管研究研究心血管研究
- 医疗保健服务研究 医疗服务研究
背景情况:
- 随机对照试验 (RCT) 在招募,合规和外部有效性方面面临挑战,特别是在心血管研究中,治疗侵入性各不相同.
- 患者的偏好可以显著影响试验结果,但在传统的RCT设计中往往未得到充分利用.
研究的目的:
- 引入和倡导患者偏好控制试验设计,以提高临床研究的效率和通用性.
- 展示如何结合患者偏好可以解决传统RCT的局限性,特别是在心血管干预中.
主要方法:
- 描述患者偏好控制的设计,积极参与患者的治疗分配.
- 建议混合试验设计,结合随机和基于偏好的队列.
- 使用贝叶斯建模来整合跨队列的效果估计,并调整混.
主要成果:
- 患者偏好控制试验可以在测量和控制混影响 (例如,医生偏见,功能状态) 时产生有效和可靠的治疗效果估计.
- 混合设计保留了随机化的内部有效性,同时扩大了招聘并提高了外部有效性.
- 在适当的设计条件下,偏好可以作为有效的仪器变量.
结论:
- 患者偏好控制试验为心血管研究和其他领域提供了严格的,未充分利用的方法.
- 这种方法通过前性地解决和量化偏差,为RCT的局限性提供了实际解决方案.
- 需要正式的设计和报告准则来促进这些以患者为中心的试验设计的采用.
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