Analyzing population-level trials as N-of-1 trials: An application to gait.

ABSTRACT

Studying individual causal effects of health interventions is important 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. As an alternative method, we propose to re-analyze existing population-level studies as N-of-1 trials, and 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. As a reference to the N-of-1 trials approach, 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 repeated-measures 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 revealed differences between participants. Baseline values of the gait parameters varied largely among all participants, and the effects of fatigue and cognitive task were also heterogeneous, with some individuals showing effects in opposite directions. 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.