CONSORT Flow Diagram Generator
Fill in how many people were assessed, randomised, followed up and analysed in each group. The diagram updates as you type, the numbers are checked at every stage, and you can download an editable Word file or a 300 dpi image. The example below is a fictional two-arm trial.
Your CONSORT flow diagram
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Assessed for eligibility (n = 412)
Excluded (n = 112) • Not meeting inclusion criteria (n = 78) • Declined to participate (n = 26) • Other reasons (n = 8) – Enrolment target reached at site (n = 8)
Randomised (n = 300)
Allocated to Exercise programme (n = 150) • Received allocated intervention (n = 144) • Did not receive allocated intervention (n = 6) – Withdrew consent before first session (n = 4) – Became ineligible (n = 2)
Allocated to Usual care (n = 150) • Received allocated intervention (n = 150) • Did not receive allocated intervention (n = 0)
Lost to follow-up for primary outcome (n = 9) – Moved away (n = 5) – Could not be contacted (n = 4) Discontinued intervention (n = 12) – Adverse event (n = 5) – Lack of time (n = 7)
Lost to follow-up for primary outcome (n = 11) – Did not attend the 12-week visit (n = 11) Discontinued intervention (n = 0)
Analysed for primary outcome (n = 141) Excluded from analysis (n = 0)
Analysed for primary outcome (n = 138) Excluded from analysis (n = 1) – Randomised in error (did not meet inclusion criteria) (n = 1)
Counts are consistent
Checks cover the arithmetic of the flow, not whether the trial followed CONSORT.
Fix the count issues and tick the confirmation to download. You can always save the project or export a marked draft.
Your numbers stay in this browser and in files you download. Nothing is sent to a server.
What a CONSORT flow diagram shows
The CONSORT flow diagram follows every participant in a randomised trial from screening to the primary analysis. It answers the questions a reader or reviewer asks first: how many people were eligible, how many were randomised to each group, how many dropped out and why, and how many were analysed.
The CONSORT statement (Consolidated Standards of Reporting Trials) recommends the diagram as part of reporting participant flow, and most journals that publish trials expect it as Figure 1. The current version is CONSORT 2025, published in April 2025 in the BMJ, JAMA, The Lancet, Nature Medicine and PLOS Medicine. For what else changed in the 2025 checklist, read our guide to CONSORT 2025 for trial authors.
What goes in each box
| Stage | Box | How to count it |
|---|---|---|
| Enrolment | Assessed for eligibility | Everyone screened against the inclusion criteria, from the screening log. |
| Enrolment | Excluded: not meeting inclusion criteria, declined to participate, other reasons | People assessed but not randomised. The three counts add up to the excluded total. |
| Enrolment | Randomised | Assessed minus excluded. Every randomised person appears in exactly one group below. |
| Allocation | Allocated to each group; received or did not receive the allocated intervention | Received plus did not receive equals allocated. Give reasons for not receiving it. |
| Follow-up | Lost to follow-up for primary outcome; discontinued intervention | Count people with no primary outcome data separately from people who stopped treatment. |
| Analysis | Analysed for primary outcome; excluded from analysis | The number in the primary analysis of each group, and anyone left out, with reasons. |
In the example above, 412 people were assessed and 112 excluded, so 300 were randomised, 150 to each group. In the exercise group, 9 had no 12-week outcome, so 141 were analysed. Twelve people stopped the programme, but they were still followed up, which is why they do not reduce the number analysed.
CONSORT 2025 vs CONSORT 2010 flow diagram
The 2025 template keeps the four stages and the box layout of 2010. The wording of two boxes changed so that the counts clearly refer to the primary outcome:
- “Lost to follow-up (give reasons)” became “Lost to follow-up for primary outcome (give reasons)”.
- “Analysed” became “Analysed for primary outcome”.
Choose “CONSORT 2025” or “CONSORT 2010” under Template wording. Use 2025 unless your target journal’s instructions still name the 2010 checklist.
Common mistakes
- Treating discontinued as lost. Someone who stopped the intervention but attended the final visit is not lost to follow-up. Count them under discontinued and, in an intention-to-treat analysis, in the analysed box.
- Numbers that do not add up. Reviewers check the sums first. Use the checks next to the preview and the “Use” button to correct a total.
- Leaving out the reasons. CONSORT asks for reasons for exclusions, losses, discontinuations and analysis exclusions. Add each reason with its count; the reasons must add up to the box total.
- Silent imputation. If everyone randomised was analysed because missing outcomes were imputed, say so in the note under the figure and in the methods.
- Mixing up people and visits. Count participants, not appointments or samples, unless the unit of randomisation is different (for example clusters).
Frequently asked questions
- What is a CONSORT flow diagram?
- It is the figure that shows how participants moved through a randomised trial: how many were assessed for eligibility, excluded, randomised, allocated to each group, lost to follow-up or stopped the intervention, and finally analysed. The CONSORT statement recommends it so readers can see at a glance who was included in the results.
- What are the four stages of a CONSORT flow diagram?
- Enrolment (assessed for eligibility, excluded with reasons, randomised), Allocation (allocated to each group, received or did not receive the allocated intervention), Follow-up (lost to follow-up and discontinued intervention, with reasons) and Analysis (analysed, and excluded from analysis with reasons).
- What changed in the CONSORT 2025 flow diagram?
- The layout is the same as in 2010, but the follow-up and analysis boxes now name the primary outcome: “Lost to follow-up for primary outcome” and “Analysed for primary outcome” replace “Lost to follow-up” and “Analysed”. This makes clear which outcome the numbers refer to. The generator uses the 2025 wording by default and can switch to the 2010 wording if your journal still asks for it.
- What is the difference between lost to follow-up and discontinued intervention?
- Lost to follow-up means there is no primary outcome measurement for that person, for example because they moved away or could not be contacted. Discontinued intervention means they stopped the treatment they were allocated to. People who discontinue can, and usually should, still be followed up and analysed in their allocated group.
- Do the numbers in a CONSORT diagram have to add up?
- Yes. Assessed minus excluded should equal randomised, the groups should add up to the number randomised, and in each group the people who did and did not receive the intervention should add up to the number allocated. The generator checks these sums and lists any mismatch. Analysed does not always equal allocated minus lost, because missing outcomes may have been imputed; the tool shows that as a note to check, not an error.
- Can I make a CONSORT diagram for three or four groups?
- Yes. Choose 2, 3 or 4 randomised groups and the diagram adds a column for each. For cluster, crossover or factorial trials, use the matching CONSORT extension; you can start from this diagram and edit the Word file, for example to add numbers of clusters next to numbers of participants.
- Where does the CONSORT flow diagram go in a paper?
- It is usually the first figure, placed at the start of the Results section where participant flow is reported. Cite it in the text, for example “Figure 1 shows the flow of participants through the trial”, and give the dates of recruitment and follow-up nearby.
- Can I edit the diagram after downloading it?
- Yes. The Word download is built from ordinary text boxes and connector lines, so you can change any wording in Word. SVG and PDF stay sharp at any size, and the PNG is rendered at 300 dpi for journals that ask for an image file.
- Can I use the CONSORT flow diagram for a non-randomised study?
- CONSORT is written for randomised trials. For a cohort or other observational study, report participant numbers at each stage as STROBE item 13 asks; many authors draw a similar flow chart without the randomisation and allocation boxes.
- Is my trial data stored anywhere?
- No. The diagram is drawn in your browser and nothing is sent to a server. A draft is kept in this browser’s local storage so it is still there when you come back, and you can download the project as a file to move it to another computer.
Sources
- Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ 2025;389:e081123. doi:10.1136/bmj-2024-081123. Published under CC BY 4.0.
- Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. doi:10.1136/bmj.c332.
- Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661.
- CONSORT and SPIRIT Group. consort-spirit.org: checklists, flow diagram templates and extensions.
Content updated November 1, 2026. This is an independent tool and is not affiliated with the CONSORT Group or any journal.