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

1. Read the full manuscript
2. Confirm the study is a randomized trial; identify design (parallel, factorial, crossover, cluster)
3. Walk through each item below
4. For each item, assign: Reported / Partial / Missing / N/A
5. Quote the relevant manuscript text as evidence
6. Output a compliance summary + actionable fixes
7. 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