Clustergerandomiseerde

Clustergerandomiseerde trials are a type of clinical trial design where groups or clusters of participants, rather than individuals, are randomly assigned to different intervention arms. These clusters can be defined by various factors such as geographical location, healthcare facilities, schools, or even families. The randomization occurs at the cluster level, meaning all individuals within a specific cluster receive the same intervention. This contrasts with individually randomized controlled trials where each participant is assigned to an intervention independently.

This design is particularly useful when an intervention is inherently delivered at a group level, such as a public health campaign or a new educational program implemented in schools. It also helps to avoid contamination between intervention and control groups, a common issue in individually randomized trials where participants in the control arm might inadvertently be exposed to the intervention. However, cluster randomization introduces a level of dependency among participants within the same cluster, which needs to be accounted for in the statistical analysis. This dependency can lead to a loss of statistical power compared to an individually randomized trial with the same number of participants. Specialized statistical methods are required to handle the clustered nature of the data, often involving adjustments for the intra-cluster correlation.