Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, California.
F. Hoffmann - La Roche Ltd, Basel, Switzerland.
Alzheimers Dement. 2020 May;16(5):797-803. doi: 10.1002/alz.12058. Epub 2020 Apr 8.
In clinical trials in populations with mild cognitive impairment, it is common for participants to initiate concurrent symptomatic medications for Alzheimer's disease after randomization to the experimental therapy. One strategy for addressing this occurrence is to exclude any observations that occur after the concurrent medication is initiated. The rationale for this approach is that these observations might reflect a symptomatic benefit of the concurrent medication that would adversely bias efficacy estimates for an effective experimental therapy. We interrogate the assumptions underlying such an approach by estimating the effect of newly prescribed concurrent medications in an observational study, the Alzheimer's Disease Neuroimaging Initiative.
在轻度认知障碍患者的临床试验中，参与者在被随机分配到实验治疗后，通常会同时开始使用治疗阿尔茨海默病的症状性药物。一种解决此问题的策略是排除在开始同时使用药物后发生的任何观察结果。这种方法的基本原理是，这些观察结果可能反映了同时使用药物的症状改善，这会对有效的实验治疗的疗效估计产生不利影响。我们通过在一项观察性研究（阿尔茨海默病神经影像学倡议）中估计新处方的同时使用药物的效果，来探讨这种方法的假设。
