CONSORT 2025 statement

CONSORT 2025 at a glance

• Evidence‑based and consensus‑driven reporting guideline for randomised trials
• Replaces CONSORT 2010 and reflects new methods and open science practices
• Intended for authors, journal editors, peer reviewers, clinicians, guideline developers, patients and the public who need to appraise trial reports
• Core tools are a 30‑item checklist plus a participant flow diagram
• Focus on complete, transparent reporting of trial design, conduct, analysis and results

What is new in CONSORT 2025

• Introduces seven new items on data sharing, funding and conflicts of interest, patient and public involvement, site and provider eligibility, harms assessment, handling of missing data and intervention delivery
• Revises three items on protocol and statistical analysis plan access, reporting of changes after trial start and per‑group analysis information
• Removes one item on generalisability and integrates this content into trial limitations
• Aligns checklist wording with the SPIRIT 2025 protocol checklist
• Presented as a “living guideline” that will be updated periodically

Open science and expanded checklist

• Includes a dedicated open science section grouping trial registration, protocol and statistical analysis plan access, data and code sharing, and funding and conflicts of interest
• Offers an expanded checklist version with bullet‑point prompts for each item
• Provides prompts adapted from the explanation and elaboration document and informed by web‑based tools such as COBWEB and COBPeer

How to use CONSORT 2025 in practice

• Enables investigators to use the 30‑item checklist and flow diagram when drafting or reviewing trial manuscripts
• Applies to content rather than layout, so any journal format can be followed while still covering all items
• Encourages explicit reporting of what was planned and what was done, including registration, protocol and statistical analysis plan access, outcomes, harms and handling of missing data
• Recommends submission of a completed CONSORT 2025 checklist with the manuscript, indicating where each item is addressed, to support peer review

Additional resources and extensions

• Provides an explanation and elaboration document for item‑by‑item rationale, empirical basis and examples of good reporting
• Includes eAppendix 1 to compare CONSORT 2025 with CONSORT 2010, and eAppendix 2 for the expanded checklist with detailed sub‑item
• Allows new users to start with the main checklist and flow diagram, then move to the expanded checklist and explanation and elaboration document as needed
• Offers relevant CONSORT extensions alongside CONSORT 2025 for specific designs or data types (adaptive, cluster, crossover, early‑phase dose‑finding, factorial, non‑inferiority and equivalence, pragmatic, multi‑arm, n‑of‑1, pilot and feasibility, within‑person trials; routinely collected data; patient‑reported outcomes; harms‑focused trials)

The website also provides links to the joint SPIRIT‑CONSORT website with training materials and resources for researchers, editors, peer reviewers, patients and the public