Pilot trial · 2 arms

CONSORT 2025 example: pilot trial

CONSORT 2025 flow diagram of a pilot trial with a waiting-list control, where participants without primary outcome data are excluded from the analysis.

Open this example in the editorStart from scratch

Assessed for eligibility (n = 96)Excluded (n = 36)Not meeting inclusion criteria (n = 21)Declined to participate (n = 13)Other reasons (n = 2)Randomised (n = 60)Allocated to online programme (n = 30)Received allocated intervention (n = 27)Did not receive allocated intervention (n = 3)Never logged in (n = 3)Allocated to waiting list (n = 30)Received allocated intervention (n = 30)Did not receive allocated intervention (n = 0)Discontinued intervention (n = 6)Stopped using the programme (n = 6)Lost to follow-up for primary outcome (n = 4)No response to follow-up survey (n = 4)Discontinued intervention (n = 0)Lost to follow-up for primary outcome (n = 3)No response to follow-up survey (n = 3)Analysed for primary outcome (n = 24)Excluded from analysis (n = 2)Primary outcome incomplete (n = 2)Analysed for primary outcome (n = 26)Excluded from analysis (n = 1)Primary outcome incomplete (n = 1)EnrolmentAllocationFollow-upAnalysis
Participant flow of a pilot trial with exclusions from a complete-case analysis. Illustrative data.

About this example

Pilot and feasibility trials report recruitment and retention as outcomes in their own right, so the flow diagram carries much of the result: 60 of 96 people screened were randomised, and follow-up surveys were returned by most of them.

Participants with incomplete primary outcome data are listed under “Excluded from analysis” with the reason, which makes a complete-case analysis visible to readers. The CONSORT 2025 wording “Analysed for primary outcome” states which outcome the analysed numbers refer to.

The data

Assessed for eligibility96
Excluded (reasons)Not meeting inclusion criteria (21), Declined to participate (13), Other reasons (2)
Randomised60
Arm: online programmeallocated 30, lost to follow-up 4, analysed 24
Arm: waiting listallocated 30, lost to follow-up 3, analysed 26

The totals were calculated in the editor from the numbers typed. Open the example, replace the data with your own, and export the figure as SVG, PDF, PNG or TIFF.

More examples