需要支持干预措施的可接受性和可行性,以增加试验保留率:丹麦随机对照过敏试验中的随机可行性研究
Anne Poder Petersen1,2, Johannes Martin Schmid3, Hans Jürgen Hoffmann2
1Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.
BMJ open
|September 15, 2025
概括
在临床过敏试验中,基于自决理论的网络应用程序干预证明是可行的和可以接受的,以改善保留. 这种方法支持心理需求,增强持续参与和试验有效性.
科学领域:
- 临床试验 临床试验
- 行为科学 行为科学
- 过敏研究 研究过敏
背景情况:
- 低保留率是临床试验中的一个重大挑战,影响了整体有效性.
- 行为科学为理解和影响参与者参与提供了一个理论框架.
- 自决理论认为,支持自主,能力和相关性可以增强持续的参与.
研究的目的:
- 评估基于自决理论的干预和评估设计的可行性和可接受性.
- 在一个随机的过敏试验中,评估干预措施提高保留率的潜力.
- 在完全随机化之前,遵守医学研究委员会的复杂干预框架.
主要方法:
- 一个平行的,双臂随机可行性研究在丹麦单一地点进行过敏试验.
- 在100天的时间里,参与者通过短信链接每天收到在线问卷.
- 干预组访问了一个旨在支持基本心理需求的网络应用程序; 控制组收到了确认消息.
主要成果:
- 实现了100%的招聘率,没有后续损失,表明了优秀的保留.
- 干预组的响应率为84.5%,对照组的响应率为79.1%.
- 参与者认为这种干预是可以接受的,尽管建议进行技术调整和功能添加.
结论:
- 基于自决理论的干预和评估设计对于临床试验来说是可以接受和可行的.
- 该研究成功地证明了高的招聘和保留率.
- 解决了技术问题,并在完全随机评估之前根据参与者的反进行了改进.
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