The CONSORT 2025 statement introduces significant enhancements to improve the clarity and transparency of randomized trial reports. This update responds to recent methodological advancements and incorporates extensive feedback from the research community.
Key Revisions to the CONSORT Checklist
Researchers added seven new items to the checklist, revised three existing ones, and removed one outdated item. Additionally, the update integrates elements from key CONSORT extensions, such as those focusing on harms, outcomes, and non-pharmacological treatments. A new section dedicated to open science practices underscores the commitment to transparency in trial reporting.
Implementation and Expert Consensus
The development process included a comprehensive scoping review and the creation of a specialized database to gather empirical and theoretical evidence. An international Delphi survey with 317 participants and a two-day expert consensus meeting involving 30 experts ensured broad agreement on the proposed changes. The final CONSORT 2025 checklist comprises 30 essential items and a participant flow diagram, complemented by an expanded version with detailed bullet points for each item.
Inferences:
- Enhanced reporting guidelines will likely improve the reproducibility of randomized trials.
- The integration of open science principles may foster greater transparency and trust in research findings.
- Adoption of the updated CONSORT 2025 could standardize trial reporting across diverse medical disciplines.
Researchers, journal editors, and peer reviewers are encouraged to adopt the CONSORT 2025 guidelines to ensure comprehensive and transparent reporting of randomized trials. The expanded checklist serves as a practical tool, facilitating the inclusion of critical information that enhances the quality and reliability of published studies.
The introduction of CONSORT 2025 marks a pivotal step in refining the standards for reporting clinical trials. By addressing previous limitations and incorporating modern research practices, this update not only strengthens the integrity of trial reporting but also supports the broader scientific community in producing high-quality, transparent, and reproducible research. Stakeholders across the research spectrum will find the updated guidelines instrumental in elevating the standards of scientific communication.
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