“Create a CONSORT cluster-randomized trial flow diagram: 80 schools and 4,000 children are assessed; 68 schools and 3,400 children are randomized to intervention and control arms, with the displayed receipt, follow-up, discontinuation, and analysis counts.”
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Each major box reports schools as k and children as n where the cluster count is relevant.
Twelve schools are excluded before the 68-school randomization, with reasons shown.
Randomization splits 34 schools and 1,700 children into each arm.
The 20 control children who did not receive control are shown separately from follow-up losses and discontinuations.
The analysis boxes are reached from received treatment or control, not from loss or discontinuation boxes.
Use this format for a cluster randomized trial when schools or sites and individual participants must both be reported. Apply the current CONSORT extension and the study protocol to the final report.
Dúvidas comuns
What do k and n mean in the boxes?
k is the number of clusters, here schools, and n is the number of individual children.
Why show children who did not receive control?
The box accounts for the difference between the 1,700 allocated control children and the 1,680 who received control.
Should lost-to-follow-up participants point to the analysis box?
Not in this flow. They are reported as a loss, while the analysis box is reached from the received arm population.
Is this sufficient for a CONSORT report?
It is a useful flow display, but the final report must follow the applicable CONSORT checklist and trial protocol.