Sima Adam P, Stromberg Katharine A, Kreutzer Jeffrey S
Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.
Departments of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA, USA.
Contemp Clin Trials Commun. 2021 Jan 20;21:100727. doi: 10.1016/j.conctc.2021.100727. eCollection 2021 Mar.
Wait-list control clinical trials are popular among psychologists and rehabilitation specialists partly because all participants receive the intervention. In 2 arm wait-list control trials, individuals randomized to the treatment group receive immediate treatment whereas individuals randomized to the control group wait a fixed amount of time before intervention is initiated. For interventions that have varying durations, careful consideration must be given to the period that participants in the control group have a delay until treatment begins, as incongruent wait times compared to the intervention durations of the treatment group may introduce confounding into the evaluation of the treatment differences. To alleviate this issue, we propose to adaptively assign wait times to individuals randomized to the control group based on the intervention duration of those in the treatment group. Simulations demonstrate the that our method not only results in similar timing distributions between participants in the treatment and control groups, but also allows participants in the control group to initiate treatment earlier than the traditional design. The latter characteristic may reduce dropout and result in more efficient study enrollment.
等待名单对照临床试验在心理学家和康复专家中很受欢迎，部分原因是所有参与者都能接受干预。在双臂等待名单对照试验中，随机分配到治疗组的个体立即接受治疗，而随机分配到对照组的个体则要等待一段固定的时间才开始干预。对于持续时间不同的干预措施，必须仔细考虑对照组参与者在开始治疗前的延迟时间，因为与治疗组干预持续时间不一致的等待时间可能会在评估治疗差异时引入混杂因素。为了缓解这个问题，我们建议根据治疗组个体的干预持续时间，为随机分配到对照组的个体自适应地分配等待时间。模拟结果表明，我们的方法不仅能使治疗组和对照组参与者的时间分布相似，还能让对照组参与者比传统设计更早开始治疗。后一个特点可能会减少失访率，并提高研究招募的效率。
