Epidemiol Psychiatr Sci. 2011 Dec;20(4):307-9. doi: 10.1017/s2045796011000515.
Although randomised controlled trials are the reference methodology to assess the effects of therapeutic interventions, for interventions that naturally occur in groups of individuals random allocation of participants may be inappropriate. In these cases, the unit of random allocation may be the group or cluster, rather than the individual. Clinical trials that randomly allocate groups or clusters of individuals are called cluster randomised trials. This article briefly presents the main implications of cluster randomisation with respect to the following methodological aspects: generalisability, concealment of allocation, comparability at baseline, blindness, loss of clusters and intra-class correlation.
虽然随机对照试验是评估治疗干预效果的参考方法，但对于自然发生在个体群体中的干预措施，随机分配参与者可能不适用。在这些情况下，随机分配的单位可能是群体或聚类，而不是个体。随机分配个体群体或聚类的临床试验称为整群随机试验。本文简要介绍了整群随机化在以下方法学方面的主要影响：推广性、分配隐藏、基线可比性、盲法、聚类丢失和组内相关。
