CONSORT 2010 Statement¶
Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ, 340.
Cited by¶
9 citations across 9 artifacts.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Applicability Scope
- Clinical-trial reporting declares the study population through inclusion and exclusion criteria, making off-label application a recognized class of out-of-scope use.
This sourceThe reporting standard requires trials to declare eligibility (inclusion/exclusion) criteria — the study population that bounds where the findings apply and makes off-label use a recognized out-of-scope class.
Supported in partVerified against the work's full text
CONSORT 2010 has a checklist item on eligibility of participants, which supports the declared-population part; off-label use as an out-of-scope class is not mentioned.
“item 4 addresses eligibility of participants and the settings and locations of data collection.”
- Clinical-trial reporting declares the study population through inclusion and exclusion criteria, making off-label application a recognized class of out-of-scope use.
- Blinding
- In clinical and biomedical research, single-, double-, and triple-blind designs, allocation concealment, and blinded adjudication all sever the expectancy channel.
This sourceDefines blinding and allocation concealment as distinct safeguards, specifying who is blinded (participants, caregivers, outcome assessors) and the targeted severance of the treatment-assignment channel from the judgment.
- In clinical and biomedical research, single-, double-, and triple-blind designs, allocation concealment, and blinded adjudication all sever the expectancy channel.
- Bracketing
- Experimental design (blinding as institutional bracketing): double-blind trials structurally suspend the use of assignment information; blinding removes the information while bracketing suspends its use, kin but distinct.
This sourceSpecifies blinding (double-blind) as the structural suspension of assignment information in randomized trials so it cannot act on assessment.
- Experimental design (blinding as institutional bracketing): double-blind trials structurally suspend the use of assignment information; blinding removes the information while bracketing suspends its use, kin but distinct.
- Data Leakage
- In scientific and clinical research, it appears as outcome information leaking into supposedly blinded measurement, treatment information leaking into blinded outcome assessment, or test-set patients leaking into training cohorts — remedied by blinding, holdout cohorts, and pre-registration.
This sourceStandard for blinding, allocation concealment, and pre-registration that prevent outcome and treatment information from contaminating trial measurement.
- In scientific and clinical research, it appears as outcome information leaking into supposedly blinded measurement, treatment information leaking into blinded outcome assessment, or test-set patients leaking into training cohorts — remedied by blinding, holdout cohorts, and pre-registration.
- Impartiality
- Schulz, Altman, and Moher's (2010) CONSORT 2010 statement makes randomization and concealment the operationalization of impartiality in clinical research — the assignment function must not depend on the identity of the patient or investigator beyond the legitimate stratification variables.
Supported in partVerified against the work's full text
CONSORT 2010 asks trial reports to describe allocation concealment and randomisation steps; it is a reporting guideline and never mentions impartiality or the assignment-function idea.
“Item 9 (allocation concealment mechanism)— We reworded this to include mechanism in both the report topic and the descriptor to reinforce that authors should report the actual steps taken to ensure allocation concealment”
- Schulz, Altman, and Moher's (2010) CONSORT 2010 statement makes randomization and concealment the operationalization of impartiality in clinical research — the assignment function must not depend on the identity of the patient or investigator beyond the legitimate stratification variables.
- Selective Information Severance
- In experimental design it is blinding: in a double-blind trial the treatment-assignment channel is severed from both the patient (so expectation cannot produce a placebo response that contaminates the measure) and the assessor (so the evaluator's belief cannot bias the outcome rating), with the assignment held only by a party who never interacts with the measurement — the canonical case where not knowing is what makes the measurement trustworthy.
This sourceDefines blinding of participants and outcome assessors and the concealment of treatment allocation that prevents expectation and assessor bias from contaminating the measure.
- In experimental design it is blinding: in a double-blind trial the treatment-assignment channel is severed from both the patient (so expectation cannot produce a placebo response that contaminates the measure) and the assessor (so the evaluator's belief cannot bias the outcome rating), with the assignment held only by a party who never interacts with the measurement — the canonical case where not knowing is what makes the measurement trustworthy.
Domain-specific¶
Mechanisms¶
- Participant Flow Diagram
- The CONSORT flow diagram
This sourceMakes a participant-flow diagram a CONSORT reporting element for showing assignment, treatment receipt, follow-up losses, exclusions, and analysis denominators.
- The CONSORT flow diagram
- Random Assignment
- The discipline that preserves it is to analyze units by the group they were assigned to, regardless of what they actually did — the intention-to-treat principle
This sourceRequires analysis by original assignment and transparent reporting of baseline characteristics, exclusions, missing outcomes, and attrition.
- The discipline that preserves it is to analyze units by the group they were assigned to, regardless of what they actually did — the intention-to-treat principle
Verification¶
Does it exist? Confirmed. This work's DOI resolves to a registered record, which fixes its identity. That is all it fixes.
Does it back the claim? Read against the text for 3 of 9 citations: 3 supported in part. Each verdict is shown under its citation below, with what in the work backs the sentence.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
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