CONSORT 2025 · Item 14
Outcomes
Pre-specified primary and secondary outcomes, including the specific measurement variable (e.g., systolic blood pressure), analysis metric (e.g., change from baseline, final value, time to event), method of aggregation (e.g., median, proportion), and time point for each outcome
Partly met
The primary outcome names its measurement variable and nothing else. No analysis metric, no method of aggregation and no time point is given for it, and the secondary outcomes are listed without any of the four.
Quoted from your manuscript
The primary outcome was self-reported sleep quality, measured with the Pittsburgh Sleep Quality Index.
Secondary outcomes included daytime fatigue, mood, and adherence to the programme.
Where it applies
Methods · Outcome measures · p. 6
What to address
For each outcome, state the analysis metric, the method of aggregation and the time point of interest, and say who assessed it. Mark which of the three secondary outcomes were pre-specified in the protocol. Both belong in Methods, under Outcome measures.
The work it cites
Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 Statement: updated guideline for reporting randomised trials. BMJ. 2025;388:e081123. consort-spirit.org
An illustration on a synthetic two-arm trial. No real manuscript was assessed.
