使用虚拟多团队系统在C部分进行多站点随机临床试验 早期干预系统:好处,挑战和经验教训
Brooke Ingersoll1, Anthuanet Espinel1, Julia Nauman1
1Department of Psychology, Michigan State University, 316 Physics Rd., Room 105B, East Lansing, MI 48824, USA.
Contemporary clinical trials
|May 31, 2024
概括
虚拟多团队系统在COVID-19期间成功收集了多站点临床试验的数据. 这种方法证明了培训和评估的可行性,为未来的研究提供了一个模型.
科学领域:
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
- 实施科学 实施科学
背景情况:
- COVID-19扰乱了传统的个人数据收集用于研究.
- 虚拟多团队系统 (VMTS) 为地理分散的团队提供了技术解决方案.
- 通过技术介导的沟通,VMTS促进了合作.
研究的目的:
- 介绍使用VMTS进行多站点随机化混合有效性实施试验的案例研究.
- 描述应对COVID-19的团队结构和数据收集方法的适应.
- 在临床试验中证明虚拟方法的可行性.
主要方法:
- 从特定站点,共定位的团队过渡到跨站点的虚拟团队.
- 适应初级数据收集活动进行虚拟执行.
- 收集了关于参与者人口统计,跨站点活动百分比和忠诚度的数据.
主要成果:
- 在20个月内招募了108名EI提供者和132个家庭,其消耗率低 (17%的提供者,9%的家庭).
- 参与者样本在种族/种族,教育和收入方面表现出显著的多样性.
- 大多数提供者培训和大约50%的家庭评估都是在跨站点进行的.
结论:
- 在C部分系统中,虚拟团队,培训和评估对于多站点临床试验是可行的.
- 该研究强调了未来虚拟多站点试验的优势,挑战和经验教训.
- 这种VMTS方法为远程进行复杂的临床研究提供了一个可行的模型.
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