CONSORT 2025 Compliance Checker
Audit randomized controlled trial manuscripts against the CONSORT 2025 (Consolidated Standards of Reporting Trials) 30-item checklist. Published April 2025, supersedes CONSORT 2010.
What Changed from CONSORT 2010
- 7 new items added (data sharing, conflicts of interest, PPI, site eligibility, harms assessment, analysis population, intervention delivery)
- 3 items revised (protocol access, post-commencement changes, missing data)
- 1 item deleted (generalisability — now incorporated into Limitations, item 30)
- New Open Science section (items 2-5)
- Renumbered throughout (do NOT use CONSORT 2010 numbering)
Workflow
- Read the full manuscript
- Confirm the study is a randomized trial; identify design (parallel, factorial, crossover, cluster)
- Walk through each item below
- For each item, assign: Reported / Partial / Missing / N/A
- Quote the relevant manuscript text as evidence
- Output a compliance summary + actionable fixes
- Check for CONSORT flow diagram (strongly recommended)
CONSORT 2025 Checklist (30 Items)
Title and Abstract
| # | Topic | Requirement |
|---|---|---|
| 1a | Title | Identification as a randomised trial in the title |
| 1b | Abstract | Structured summary of trial design, methods, results, and conclusions |
Open Science (NEW section)
| # | Topic | Requirement |
|---|---|---|
| 2 | Trial registration | Registry name, identifying number with URL, and registration date |
| 3 | Protocol and SAP access | Where the trial protocol and statistical analysis plan can be accessed |
| 4 | Data sharing | NEW. Where and how de-identified participant data (including data dictionary), statistical code, and other materials can be accessed |
| 5a | Funding | Sources of funding and other support; role of funders in design, conduct, analysis, reporting |
| 5b | Conflicts of interest | NEW. Financial and other conflicts of interest of the manuscript authors |
Introduction
| # | Topic | Requirement |
|---|---|---|
| 6 | Background/rationale | Scientific background and rationale based on existing evidence |
| 7 | Objectives | Specific objectives related to benefits and harms, using PICO framework |
Methods
| # | Topic | Requirement |
|---|---|---|
| 8 | Patient/public involvement | NEW. Details of patient or public involvement in the design, conduct, and reporting of the trial |
| 9 | Trial design | Type of design (parallel, crossover, factorial, etc.), allocation ratio, framework (superiority, non-inferiority, equivalence) |
| 10 | Protocol changes | REVISED. Important changes to the trial after commencement, with reasons and timing |
| 11 | Trial setting | Settings and geographical locations where the trial was conducted |
| 12a | Participant eligibility | Eligibility criteria for participants |
| 12b | Site/provider eligibility | NEW. Eligibility criteria for sites and individuals delivering interventions |
| 13 | Interventions | Sufficient details to allow replication; how and when administered; access to intervention manuals/materials |
| 14 | Outcomes | Pre-specified primary and secondary outcomes: measurement variables, analysis metrics, aggregation methods, timepoints |
| 15 | Harms assessment | NEW. How harms were defined and assessed (systematically vs non-systematically) |
| 16a | Sample size | How sample size was determined, with all supporting assumptions |
| 16b | Interim analyses | Explanation of interim analyses and stopping guidelines |
| 17a | Randomisation — sequence | Who generated sequence; method used |
| 17b | Randomisation — type | Type of randomisation; details of restriction (stratification, blocking) |
| 18 | Allocation concealment | Mechanism to implement allocation sequence; steps taken to conceal until assignment |
| 19 | Implementation | Whether personnel accessing the allocation sequence could foresee assignment |
| 20a | Blinding — who | Who was blinded after assignment (participants, care providers, outcome assessors) |
| 20b | Blinding — how | How blinding was achieved; description of similarity of interventions |
| 21a | Statistical methods | Methods for comparing groups for primary/secondary outcomes and harms |
| 21b | Analysis population | NEW. Definition of who is included in each analysis and how group assignment was handled |
| 21c | Missing data | REVISED. How missing data were handled in the analysis |
| 21d | Additional analyses | Methods for subgroup and sensitivity analyses, distinguishing pre-specified from post hoc |
Results
| # | Topic | Requirement |
|---|---|---|
| 22a | Participant flow | For each group: numbers randomised, received intervention, analysed. Flow diagram strongly recommended |
| 22b | Losses/exclusions | Losses and exclusions after randomisation, with reasons |
| 23a | Recruitment dates | Periods of recruitment and follow-up for outcomes of benefits and harms |
| 23b | Trial termination | Why the trial ended or was stopped |
| 24a | Intervention delivery | NEW. Intervention and comparator as actually administered, including fidelity |
| 24b | Concomitant care | Care received during the trial for each group |
| 25 | Baseline characteristics | Table of baseline demographic and clinical characteristics for each group |
| 26 | Outcomes | Numbers analysed, available data, results per group, effect sizes with confidence intervals |
| 27 | Harms | All harms or unintended events in each group |
| 28 | Ancillary analyses | Other analyses performed, distinguishing pre-specified from post hoc |
Discussion
| # | Topic | Requirement |
|---|---|---|
| 29 | Interpretation | Interpretation consistent with results, balancing benefits and harms, considering other evidence |
| 30 | Limitations | REVISED. Trial limitations: bias, imprecision, generalisability, and multiplicity of analyses (generalisability now incorporated here; was a separate item in 2010) |
Critical CONSORT 2025 Elements
| Must-Have | Why |
|---|---|
| Flow diagram (22a) | Journals typically will not review without one |
| Trial registration (2) | Mandatory for ICMJE journals; prospective registration expected |
| Randomisation details (17-19) | Core of trial integrity reporting |
| Sample size (16a) | Reviewers check this immediately |
| Analysis population / ITT (21b) | Must define who is included and how; state ITT or per-protocol |
| Harms (15, 27) | Both assessment method AND results now required |
| Data sharing (4) | New open science requirement; increasingly mandated |
Common CONSORT 2025 Gaps
| Frequently Missing | Fix |
|---|---|
| Item 4 (Data sharing) | State data availability policy; provide repository URL or explain restrictions |
| Item 5b (Conflicts) | Add explicit COI disclosure for each author |
| Item 8 (PPI) | Describe patient involvement or state "No patient or public involvement" |
| Item 12b (Site eligibility) | State criteria for site and provider selection |
| Item 15 (Harms assessment) | Describe how AEs were defined, collected, and classified |
| Item 21b (Analysis population) | State ITT/mITT/per-protocol explicitly; define who was included |
| Item 21c (Missing data) | Describe imputation or complete-case approach |
| Item 24a (Intervention delivery) | Report fidelity and actual administration vs protocol |
Output Format
CONSORT 2025 Compliance Report
Trial design: [Parallel / Factorial / Crossover / Cluster]
Manuscript: [filename]
Summary: X/30 Reported | Y Partial | Z Missing | W N/A
CRITICAL MISSING (journal will likely reject):
[Item #] [Topic] — [What's needed]
NEW ITEMS IN 2025 (check carefully):
[Item #] [Topic] — [Status]
OTHER MISSING:
[Item #] [Topic] — [What's needed]
PARTIAL ITEMS:
[Item #] [Topic] — [What's present] → [What's missing]
Flow diagram: [Present / Missing]
Trial registration: [Registered (ID) / Not registered / Not stated]
Data sharing statement: [Present / Missing]Related Skills
/manuscript— Overall manuscript writing and anti-pattern scanning