CONSORT 2025 Checklist: All 30 Items, Section by Section
The 30 CONSORT 2025 items explained in plain words, what reviewers object to in each block, and a checker that reads your trial in the browser.
CONSORT 2025 is the guideline for reporting a randomized trial so that someone else can judge it and repeat it. It has 30 items in six sections (title and abstract, open science, introduction, methods, results and discussion) and replaces CONSORT 2010, which had 25. It was published in April 2025 in five journals at once.
By Víctor Ciudad-Fernández, PhD · Updated: October 6, 2026 · Source: Hopewell et al. (2025)
What CONSORT 2025 is and when to use it
CONSORT (Consolidated Standards of Reporting Trials) does not tell you how to design the trial: it tells you what the article has to contain so that readers can judge whether the result is credible. The 2025 version, by Hopewell and colleagues, appeared simultaneously in The BMJ, JAMA, The Lancet, Nature Medicine and PLOS Medicine, together with an explanation and elaboration paper that develops each item with examples.
Most biomedical journals that publish trials ask for the completed checklist at submission, with the page or line where each item is met. If an item does not apply to your trial, write that it does not apply and why: a blank box is what gets a submission sent back by the editorial office.
Two-arm, parallel-group randomized trials: the case it is written for.
Other randomized designs (cluster, crossover, non-inferiority, pilot): CONSORT 2025 plus the matching extension. While the extensions are being aligned with the new version, the CONSORT group recommends using the current version of each one.
The trial protocol does not go with CONSORT but with SPIRIT 2025, its counterpart for protocols.
A non-randomized or quasi-experimental study is not a CONSORT trial: use TREND or, if it is observational, STROBE.
The 30 items, section by section
Some items have sub-items (1a and 1b, 12a and 12b…), so in practice you fill in more than 30 boxes. What follows explains each one in plain words; for submission, use the official checklist. Under each section you have what reviewers usually object to in it.
Title and abstract
1a. The title says it is a randomized trial.
1b. A structured abstract with design, methods, results and conclusions (there is a separate checklist for abstracts).
What reviewers usually object to:
The title does not say "randomized" and the editor does not identify it as a trial.
The abstract gives the p value for the primary outcome but not the effect size with its confidence interval.
The conclusion of the abstract rests on a secondary outcome that came out significant, not on the primary one.
Open science
2. The registration: name of the registry, identifying number with its link, and date of registration. (checked by the checker)
3. Where the protocol and the statistical analysis plan can be accessed.
4. Where and how the de-identified individual data (with a data dictionary), the analysis code and other materials can be accessed.
5a. Who funded the trial and what role the funder played in design, conduct, analysis and reporting.
5b. The financial and other conflicts of interest of the authors.
What reviewers usually object to:
The trial was registered after recruitment started, or the primary outcome in the registry is not the one in the article.
There is no statistical analysis plan, so there is no way to know which analysis was planned before seeing the data.
"Data are available on reasonable request", without saying from whom, how, or on what terms.
Introduction
6. The scientific background and why this trial was needed.
7. The specific objectives, for both benefits and harms.
What reviewers usually object to:
The need for the trial is not justified: no previous systematic review is cited and the gap it fills is not explained.
The objectives only mention efficacy, and harms appear later without having been set out.
Methods
8. Whether patients or the public were involved in the design, conduct or reporting of the trial, and how.
9. The design: type of trial (parallel, crossover…), allocation ratio and framework (superiority, equivalence, non-inferiority, exploratory).
10. Important changes after the trial started, including outcomes or analyses that were not prespecified, with the reason.
11. The settings (community, hospital…) and locations (countries, sites) where it was run.
12a. The eligibility criteria for participants. (checked by the checker)
12b. If applicable, the eligibility criteria for sites and for the people delivering the intervention.
13. The intervention and comparator in enough detail to replicate them, and where to find the materials (for example, the intervention manual).
14. The prespecified primary and secondary outcomes: which variable, which metric (change from baseline, final value, time to event), how it is aggregated and at what time point.
15. How harms were defined and collected (systematically or not).
16a. How the sample size was determined, with every assumption behind the calculation. (checked by the checker)
16b. Any interim analyses and stopping rules.
17a. Who generated the random allocation sequence and with what method.
17b. The type of randomization and its restrictions (stratification, blocks and block size).
18. How the sequence was concealed until each participant was assigned (central system, sequentially numbered opaque envelopes…).
19. Whether the people enrolling and assigning participants had access to the sequence.
20a. Who was blinded after assignment (participants, care providers, outcome assessors, analysts). (checked by the checker)
20b. If there was blinding, how it was achieved and how similar the interventions were.
21a. The statistical methods used to compare groups on primary and secondary outcomes, harms included.
21b. Who is included in each analysis (for example, everyone randomized) and in which group.
21c. How missing data were handled in the analysis.
21d. Any additional analyses (subgroups, sensitivity), separating the prespecified from the post hoc.
What reviewers usually object to:
The sample size calculation does not say where the expected effect comes from, or it was done for an outcome other than the primary one.
"Participants were randomized", with no method, no one named as generating the sequence and no concealment: that cannot be told apart from first-come, first-served allocation.
Allocation concealment (before assignment) is confused with blinding (after assignment).
An intention-to-treat analysis is claimed, but people who did not complete follow-up are excluded.
The primary outcome in the article is not the registered one and the change is not explained.
Missing data are handled with complete cases, without justification or a sensitivity analysis.
Results
22a. For each group, how many were randomized, received the intended intervention and were analyzed for the primary outcome; a flow diagram is strongly recommended. (checked by the checker)
22b. For each group, losses and exclusions after randomization, with reasons. (checked by the checker)
23a. The dates that define the recruitment and follow-up periods.
23b. If relevant, why the trial ended or was stopped.
24a. The intervention and comparator as they were actually delivered (adherence, who delivered them).
24b. The concomitant care each group received during the trial.
25. A table with the baseline demographic and clinical characteristics of each group.
26. For each outcome and group: how many were analyzed, how many had data at that time point, the result in each group and the estimated effect with its precision (confidence interval); for binary outcomes, both the absolute and the relative effect.
27. All important harms or unintended effects in each group.
28. Any other analyses (subgroups, sensitivity), distinguishing the prespecified from the post hoc.
What reviewers usually object to:
The numbers in the flow diagram do not match the tables or the N in the text.
The baseline table carries p values comparing the groups: in a randomized trial they are pointless, because baseline differences are chance by definition.
For a binary outcome, the relative difference (RR or OR) is given without the absolute one, or the other way around.
Harms are summed up in one sentence ("there were no serious adverse events") with no numbers per group.
Post hoc subgroups are presented as if they had been planned.
Discussion
29. An interpretation consistent with the results that weighs benefits and harms and considers other evidence.
30. The limitations of the trial: sources of bias, imprecision, generalizability and, if relevant, multiplicity of analyses.
What reviewers usually object to:
The discussion presents as effective an intervention whose confidence interval includes the null effect.
The limitations are generic ("small sample") and do not say in which direction they could bias the result.
Check your manuscript against CONSORT 2025
Paste the article (Methods and Results at a minimum). The checker searches the text for 6 of the 30 CONSORT 2025 items, the ones a text search can decide without reading (participant flow diagram, blinding (or its declared absence), sample size calculation, trial registration, losses to follow-up per arm, inclusion and exclusion criteria), and shows you the sentence that supports each one. It runs in your browser: nothing is uploaded or stored.
Checklist checker: Detects the design and picks the guideline for you.
Previum · AI peer review. A checklist tells you whether something appears in the text; it does not tell you whether it was done right. Once the manuscript is complete, see what Reviewer 2 would object to before you submit: findings anchored to your text, in the margin. Review my manuscript
What changed from CONSORT 2010
CONSORT 2010 had 25 items. According to the statement itself, the 2025 version adds seven new items, revises three, deletes one and integrates elements of key CONSORT extensions. The result is 30 items.
What you notice most when filling it in: the new open science section (registration, protocol and analysis plan, access to data and code, funding and conflicts), patient and public involvement, how harms were defined and collected, how missing data were handled, and how the intervention was actually delivered.
If your journal still links to the 2010 checklist, check its instructions to see which one it wants. The numbering is different, so do not mix the two in the same submission.
How to cite the guideline
If your Methods section says you followed CONSORT 2025, cite the statement (and, if you rely on it, the explanation and elaboration), not this page.
Hopewell, S., Chan, A.-W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., Bhandari, N., Butcher, N. J., Campbell, M. K., Chidebe, R. C. W., Elbourne, D., Farmer, A., Fergusson, D. A., Golub, R. M., Goodman, S. N., … Boutron, I. (2025). CONSORT 2025 statement: Updated guideline for reporting randomised trials. BMJ, 389, e081123. https://doi.org/10.1136/bmj-2024-081123
Hopewell, S., Chan, A.-W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., Bhandari, N., Butcher, N. J., Campbell, M. K., Chidebe, R. C. W., Elbourne, D., Farmer, A., Fergusson, D. A., Golub, R. M., Goodman, S. N., … Boutron, I. (2025). CONSORT 2025 explanation and elaboration: Updated guideline for reporting randomised trials. BMJ, 389, e081124. https://doi.org/10.1136/bmj-2024-081124
It has 30. The 25 belong to CONSORT 2010, the previous version. Several items have sub-items, so the checklist has more boxes than numbers.
What do I write if an item does not apply to my trial?
Write "not applicable" and one sentence explaining why, for example "no interim analyses planned" for 16b. What does not work is leaving the box empty or giving a page number where nothing is said.
Does CONSORT work for a pilot study or a quasi-experiment?
For a randomized pilot, yes, with the extension for pilot and feasibility trials. For a quasi-experiment without randomization, no: the guideline usually requested is TREND.
What is the difference between CONSORT and SPIRIT?
SPIRIT is for the protocol, what you are going to do; CONSORT is for the results article, what you did. Both were updated in 2025 and share a structure, so that the protocol and the article can be compared.