CLINICAL RESEARCH

Parallel-group CONSORT flow diagram

A parallel-group CONSORT flow diagram records the movement of participants through a randomized controlled trial. Begin with the number assessed for eligibility, then show exclusions with their reasons and the total randomized. Draw one branch for each allocated study arm. Within each branch, record how many participants received the assigned intervention, how many were lost to follow-up or discontinued, and how many were included in the final analysis. Counts should reconcile from one stage to the next. This diagram helps readers see attrition, departures from allocation, and the size of each analysis group without having to reconstruct those details from the text.

UPDATED 2026-09-24
EXAMPLEParallel-group CONSORT flow diagram
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CASE ANALYSIS

Scenario

Reporting participant flow in a parallel-group randomized controlled trial.

Key decisions

  • Screening count: Show everyone assessed before exclusions.
  • Allocation counts: Keep randomized participants separate by study arm.
  • Attrition reasons: State losses and discontinuations before analysis.
  • Analysis set: Report the count included in each final analysis.

When to reuse this

Use this structure for a standard two-arm randomized controlled trial with a single follow-up period.

FAQ

Frequently asked questions

What counts belong in a CONSORT flow diagram?01
Show counts for assessment, exclusion, randomization, allocation, follow-up, and analysis, with reasons where participants leave the study.
Should each study arm have its own branch?02
Yes. Separate branches make allocation, attrition, and final analysis counts clear for each arm.
Do the counts need to reconcile?03
Yes. The participant totals at each stage should explain how the randomized total leads to the final analysis sets.
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