Cluster randomized CONSORT flow diagram
A cluster randomized CONSORT flow diagram must show both the clusters that are randomized and the participants within them. Start with sites, practices, schools, or wards assessed for inclusion, then state how many clusters were excluded and randomized. Each allocation branch should name the number of clusters and the number of participants enrolled. During follow-up, distinguish a cluster that withdraws from participants who are lost within a retained cluster. The final analysis boxes should state the number of clusters and people analysed, because the unit of randomization affects how results are interpreted. This layout makes the structure of a cluster trial visible at a glance.
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Scenario
Reporting cluster and participant flow in a site-randomized trial.
Key decisions
- Cluster unit: Start with sites because they are randomized.
- Participant totals: Show enrolled people inside each site arm.
- Cluster retention: Report sites retained separately from people followed.
- Analysis unit: State both sites and participants in the final boxes.
When to reuse this
Use this form for cluster randomized trials in which practices, schools, wards, or other groups are allocated.
Frequently asked questions
What is different about a cluster CONSORT diagram?
Should site losses be shown separately?
What can count as a cluster?
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