Blinding Section
CONSORT 2025 asks randomized-trial reports to state who was blinded after assignment and, where relevant, how blinding was achieved, because awareness of assignment can affect trial conduct or outcome assessment. Some trials cannot blind all groups, and some are intentionally open label. Report the actual design rather than implying blinding that did not occur.
A Blinding section states who was unaware of treatment assignment after allocation and how blinding or masking was maintained when it was used.
Key details
Important caveats
Scope Boundary
Some trials cannot blind all groups, and some are intentionally open label. Report the actual design rather than implying blinding that did not occur.
Further guidance
Content
State who was blinded and how; avoid vague labels such as “double blind” when a clearer description of the blinded groups is available.
Purpose
Identify the participant, care-provider, outcome-assessor, or analyst groups that were blinded, and describe the relevant mechanism when the design used blinding.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- CONSORT 2025 statement: updated guideline for reporting randomised trials (opens in a new tab)BMJ / CONSORT Group · Primary 2025 CONSORT reporting guideline for randomized trials, including participant flow and trial-registration information.