论文标题
分析人口级试验作为N-1-1试验:步态的应用
Analyzing Population-Level Trials as N-of-1 Trials: an Application to Gait
论文作者
论文摘要
研究参与者之间的干预效应是异质的,研究健康干预措施的个人因果影响就会引起人们的意义。进行N-OF-1试验是单人随机对照试验,是其分析的金标准。在这项研究中,我们建议将现有的人群级研究重新分析为N-OF-1试验作为替代方案,并将步态用作说明的用例。从16名年轻和健康的参与者中收集步态数据,在疲劳和不觉醒的情况下,以及在单任务(仅行走)和双任务(在执行认知任务的同时走路)条件下。我们首先计算出标准的人群方差分析模型,以评估条件跨条件的步态参数差异(步幅长度和步步时间)。然后,我们通过贝叶斯线性混合模型估算了干预措施对步态参数对单个级别的影响,将每个参与者视为自己的试验,并比较结果。结果表明,尽管很少有总体效果可见,但个人级别的分析显示参与者之间的差异细微差异。步态参数的基线值在所有参与者中都在很大程度上变化,而疲劳和认知任务表现引起的变化也是高度异质的,有些人在相反的方向上显示效果。与认知任务干预相比,疲劳干预措施之间人口级别和个人水平分析之间的这些差异更为明显。经过经验分析,我们更广泛地讨论了通过N-OF-1试验的镜头重新分析人口研究,并突出了重要的考虑因素和要求。我们的工作鼓励未来的研究使用人群级别的数据研究个体效应。
Studying individual causal effects of health interventions is of interest whenever intervention effects are heterogeneous between study participants. Conducting N-of-1 trials, which are single-person randomized controlled trials, is the gold standard for their analysis. In this study, we propose to re-analyze existing population-level studies as N-of-1 trials as an alternative, and we use gait as a use case for illustration. Gait data were collected from 16 young and healthy participants under fatigued and non-fatigued, as well as under single-task (only walking) and dual-task (walking while performing a cognitive task) conditions. We first computed standard population-level ANOVA models to evaluate differences in gait parameters (stride length and stride time) across conditions. Then, we estimated the effect of the interventions on gait parameters on the individual level through Bayesian linear mixed models, viewing each participant as their own trial, and compared the results. The results illustrated that while few overall population-level effects were visible, individual-level analyses showed nuanced differences between participants. Baseline values of the gait parameters varied largely among all participants, and the changes induced by fatigue and cognitive task performance were also highly heterogeneous, with some individuals showing effects in opposite direction. These differences between population-level and individual-level analyses were more pronounced for the fatigue intervention compared to the cognitive task intervention. Following our empirical analysis, we discuss re-analyzing population studies through the lens of N-of-1 trials more generally and highlight important considerations and requirements. Our work encourages future studies to investigate individual effects using population-level data.