The CONSORT statement has undergone a significant update, introducing CONSORT 2025, which integrates recent methodological advancements to elevate the clarity and transparency of randomised trial reporting, following extensive international collaboration.
Methodological Advancements Guiding the Update
A comprehensive scoping review and the creation of a specialized database of empirical and theoretical evidence informed the potential revisions to the CONSORT checklist. The project incorporated recommendations from CONSORT extension authors, other reporting guidelines like TIDieR, and invaluable feedback from various stakeholders.
Global Consensus Shapes the New Checklist
An international Delphi survey, engaging 317 participants over three rounds, along with a two-day online expert consensus meeting with 30 global experts, facilitated the assessment and refinement of proposed checklist changes.
Key inferences from the update include:
- The addition of seven new items addresses previously unmet reporting needs.
- Three existing items received revisions to reflect current standards.
- Integration of elements from major CONSORT extensions ensures comprehensive reporting.
- The new open science section underscores the importance of transparency in research.
The revised CONSORT 2025 checklist now features 30 essential items, enhanced by an expanded version with detailed bullet points that highlight critical aspects of each item. Additionally, a participant flow diagram supports the documentation process in randomised trials.
Advising authors, editors, and reviewers to adopt CONSORT 2025 will promote consistency and completeness in trial reporting. This update not only aligns with modern research practices but also fosters greater trust in published findings by ensuring methodological rigor and transparency.
Users are encouraged to consult the expanded checklist to thoroughly understand each requirement, thereby enhancing the quality of their submissions and facilitating more reliable and reproducible scientific research.
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