Runcie C.W. Chidebe: CONSORT 2025 Statement – Updated Guideline for Reporting Randomized Trials
Runcie C.W. Chidebe, Executive Director of Project PINK BLUE, shared a post on LinkedIn:
“I am excited that our CONSORT 2025 guideline is now published on Nature Medicine, The British Medical Journal (BMJ), The Lancet, Journal of the American Medical Association (JAMA), and PLOS Medicine.
For the past two years, I have been working with the SPIRIT-CONSORT executive group and the 34-member working group in the development of the “CONSORT 2025 statement: updated guideline for reporting randomized trials.” The Consolidated Standards of Reporting Trials (CONSORT) is an evidence-based, minimum set of recommendations for reporting the results of randomised trials. The original 1996 guideline (and its subsequent revisions in 2001 and 2010) sets the international standard for reporting randomized controlled trials.
In this new guideline- CONSORT 2025, we conducted a scoping review, a three-round Delphi survey with 317 international participants, culminating in a two-day expert consensus meeting involving 30 invited specialists. We integrated insights from leading CONSORT extensions (Harms, Outcomes, Non-Pharmacological Treatment), related guidelines (TIDieR). This rigorous, evidence-driven process ensured that changes reflect both methodological advances and end-user needs.
In this CONSORT 2025, we introduced seven new checklist items:
- Data-sharing plans
- Author conflicts of interest
- Patient/public involvement
- Site and deliverer eligibility
- Harms assessment
- Analysis‐population definitions, and
- Intervention‐delivery details
We revised three items:
- Expanded access to statistical analysis plans,
- Reporting of post-start changes,
- Detailed outcome data handling),
We deleted one item (generalizability) and integrated key elements from major extensions. We restructured the checklist around a new “open science” section, yielding a streamlined, 30-item core checklist plus an expanded version with bullet-point sub-elements to guide authors precisely.
I am really excited that patient and public involvement was introduced to CONSORT 2025. Thanks to Dawn Richards, Sophie Staniszewska, other patient advocates, clinicians, and the executive group. Special thanks Kwanele Asante and Dr. Folakemi Odedina (PhD) for making this happen.
We hope that authors, editors, reviewers, and other potential users will use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.”
Title: CONSORT 2025 statement: updated guideline for reporting randomized trials
Authors: Sally Hopewell, An-Wen Chan, Gary S. Collins, Asbjørn Hróbjartsson, David Moher, Kenneth F. Schulz, Ruth Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A. Berlin, Nita Bhandari, Nancy J. Butcher, Marion K. Campbell, Runcie C. W. Chidebe, Diana Elbourne, Andrew Farmer, Dean A. Fergusson, Robert M. Golub, Steven N. Goodman, Tammy C. Hoffmann, John P. A. Ioannidis, Brennan C. Kahan, Rachel L. Knowles, Sarah E. Lamb, Isabelle Boutron
Read The Full Article at Nature Medicine.
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