CONSORT (Consolidated Standards of Reporting Trials) is the reporting guideline for randomized trials, and most medical journals require it at submission. The 2025 update, published in April 2025 in several major journals at once, replaces CONSORT 2010. If you are writing up a trial now, use the 2025 checklist.
What CONSORT 2025 is
- A 30-item checklist (up from 25) of what the trial report must contain.
- A participant flow diagram showing how many people were assessed, randomized, allocated, followed up and analysed in each arm.
- An expanded checklist with bullet points for the critical elements of each item.
What changed from CONSORT 2010
- Seven new items: a data sharing statement; authors' financial and other conflicts of interest; patient and public involvement in the trial; eligibility criteria for the sites and individuals delivering the intervention; a dedicated item on how harms were assessed; an explicit definition of each analysis population; and how the intervention was actually delivered.
- A new open science section bringing together trial registration, the protocol and statistical analysis plan, and data sharing.
- Three revised items and one deleted (on generalisability).
- Content previously found only in CONSORT extensions (on harms, outcomes and non-pharmacological treatments) is now folded into the main checklist.
The flow diagram
Report, for each arm: assessed for eligibility (with reasons for exclusion), randomized, allocated and received the intervention, lost to follow-up or discontinued (with reasons), and analysed (with reasons for exclusion from analysis). Reviewers check that the numbers add up from box to box.
Statistics items reviewers check most
- The primary outcome, defined in advance and matching the registry entry.
- Sample size: how it was determined, including the assumed effect and power.
- Each analysis population defined (for example intention-to-treat), now an explicit item.
- Missing data: how many, and how they were handled.
- Effect estimates with 95% CIs for each outcome in each arm, not only P values.
- No significance tests of baseline differences in Table 1: randomization makes any difference chance by design.
Mistakes reviewers catch
- Using the 2010 checklist for a manuscript submitted after the 2025 update.
- Flow-diagram numbers that do not add up.
- A primary outcome that differs from the registered one, with no explanation.
- Relative effects only: give absolute effects too (for example, risk difference alongside the risk ratio). See relative risk vs odds ratio.
Let KyroStat do the write-up for you
KyroStat produces the data-driven parts of a CONSORT report: the participant numbers for the flow diagram, the baseline table, and effect estimates with confidence intervals for every outcome.
Frequently asked questions
Where do I find the official checklist? On the CONSORT website and in the 2025 statement, published simultaneously in several journals, including JAMA, The BMJ and The Lancet. Download the 2025 version.
What about observational studies? Use STROBE. See the STROBE checklist guide.
How do I format the statistics? By the journal's style; see how to report statistics in AMA style.