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选择与退出框架对试验招募的影响:GAMEPAD随机试验试验中的一项研究

Tayyab Shah¹, Samantha Coratti², David Farraday²

¹Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

American heart journal

|October 5, 2025

概括

选择退出招聘策略,将参与视为标准护理与积极推广,与选择加入方法相比,在临床试验中注册比例显著增加. 协议完成率没有受到影响,这表明有效的招聘方法.

科学领域:

临床试验临床试验
公共卫生公共卫生
医疗保健服务研究医疗服务研究

背景情况:

随机临床试验 (RCT) 的直接参与者招募是有效的,但战略的有效性尚不清楚.
了解最佳推广方法对于改善临床试验招生和完成至关重要.

研究的目的:

为了比较"选择"与"选择退出"招聘策略对体育活动干预RCT入学率的影响.
评估这些策略对试验方案完成率的影响.

主要方法:

在一项试验 (SWAT) 中的一项研究随机将符合条件的外周动脉疾病患者分为"选择" (电子邮件邀请) 或"选择退出" (标准护理框架 + 电话外展).
根据5176名联系的参与者的入学率和协议完成率,评估了招聘策略.

主要成果:

与"选择加入" (1.0%) 组相比",选择退出"组的入学率显著更高 (3.6%).
两支手臂之间完成试验协议步骤的速度没有显著差异.

结论:

选择退出框架与积极的外展相结合,可以大幅增加直接参与的RCT的入学率.
这种招聘方法提高了效率,而不会对参与者遵守试验协议产生负面影响.

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