Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: "Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand"

每个条件下仅设置一个集群是无效的集群随机对照试验设计,应重新定义为准实验研究。回应:“行为激活对患有亚临床抑郁症的老年人时域和频域心率变异性的影响:一项在泰国进行的集群随机对照试验”

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Abstract

Ayudhaya et al. examined the effect of Behavioral Activation on daily step count and heart rate variability among older adults with depression in a study labeled a cluster randomized controlled trial (cRCT). However, only one cluster was assigned to either of the study conditions. Such a design would have zero degrees of freedom for inferential testing, because the variation due to cluster membership cannot be estimated apart from the variation due to treatment assignment. Thus, the intervention effect is completely confounded with the cluster effect. The study should be labeled a quasi-experimental study, not a cRCT. Accordingly, the numerical results should be interpreted as associations but not evidence for causal relationships.

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