ArticleEuropean stroke journal2020
Outcome assessment by central adjudicators in randomised stroke trials: Simulation of differential and non-differential misclassification.
Article in European stroke journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Should we adjudicate outcomes in stroke trials? A systematic review.International journal of stroke : official journal of the International Stroke Society · 2023Pooled it
- Added Value of a Blinded Outcome Adjudication Committee in an Open-Label Randomized Stroke Trial.Stroke · 2022Trial
- Maternal safety outcomes of respiratory syncytial vaccination during pregnancy with a large-scale database.NPJ vaccines · 2026Article
- New York State's Paid Family Leave Program is Associated with More Equitable and Increased Use of Paid Leave Following Childbirth.Maternal and child health journal · 2023Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
introductionAdjudication of the primary outcome in randomised trials is thought to control misclassification. We investigated the amount of misclassification needed before adjudication changed the primary trial results.
resultsFor the five trials, the range of unweighted kappa values were reduced from 0.89-0.97 to 0.65-0.85 before the treatment effect was altered. This corresponded to 2.1%-6% of participants misclassified differentially for trials with a binary outcome. For the hypothetical trials, those with a larger sample size, stronger treatment effect and overall event rate closer to 50% needed a higher proportion of events non-differentially misclassified before the treatment effect became non-significant. DISCUSSION: We found that only a small amount of differential misclassification was required before adjudication altered the primary trial results, whereas a considerable proportion of participants needed to be misclassified non-differentially before adjudication changed trial conclusions. Given that differential misclassification should not occur in trials with sufficient blinding, these results suggest that central adjudication is of most use in studies with unblinded outcome assessment.
conclusionFor trials without adequate blinding, central adjudication is vital to control for differential misclassification. However, for large blinded trials, adjudication is of less importance and may not be necessary.
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Registered trials
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