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clinical research · trial reporting

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.

種類 フローチャート規格 Sugiyama layered DAG + orthogonal routingエンジン schematex-flowchart更新日 2026/9/24
Cluster trial site and participant flow
Drawing preview
依頼内容

“Draw a cluster randomized CONSORT flow diagram with 24 sites assessed, 4 excluded, 20 randomized to 10 intervention and 10 usual-care sites, enrolled participant counts, retained sites and participants, and final analysis counts.”

次はこちらAdd the reason one intervention site withdrew.Show participant losses separately from site losses.
この図に含まれるもの

図の背後にある意思決定を読み解く。

01Cluster unit

Start with sites because they are randomized.

02Participant totals

Show enrolled people inside each site arm.

03Cluster retention

Report sites retained separately from people followed.

04Analysis unit

State both sites and participants in the final boxes.

Use this form for cluster randomized trials in which practices, schools, wards, or other groups are allocated.

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よくある質問

よくある質問

What is different about a cluster CONSORT diagram?

It reports both the clusters allocated and the participants recruited or analysed within those clusters.

Should site losses be shown separately?

Yes. A lost site and a lost participant have different implications and should not be combined.

What can count as a cluster?

A clinic, school, ward, practice, community, or any group randomized as one unit can be a cluster.