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