ReviewContemporary clinical trials communications2018
Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: Secondary analysis and simulation.
Review in Contemporary clinical trials communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Should we adjudicate outcomes in stroke trials? A systematic review.International journal of stroke : official journal of the International Stroke Society · 2023Pooled it
- Outcome assessment by central adjudicators in randomised stroke trials: Simulation of differential and non-differential misclassification.European stroke journal · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 8 institutions in 6 countries.
Funding
Abstract
backgroundCentral adjudication of stroke type is commonly implemented in large multicentre clinical trials. We investigated the effect of central adjudication of diagnosis of stroke type at trial entry in the Efficacy of Nitric Oxide in Stroke (ENOS) trial.
methodsENOS recruited patients with acute ischaemic or haemorrhagic stroke, and diagnostic adjudication was carried out using cranial scans. For this study, diagnoses made by local site clinicians were compared with those by central, masked adjudicators using kappa statistics. The trial primary analysis and subgroup analysis by stroke type were re-analysed using stroke diagnosis made by local clinicians, and simulations were used to assess the impact of increased non-differential misclassification and subgroup effects.
resultsAgreement on stroke type (Ischaemic, Intracerebral Haemorrhage, Unknown stroke type, No-stroke) was high (κ = 0.92). Adjudication of stroke type had no impact on the primary outcome or subgroup analysis by stroke type. With misclassification increased to 10 times the level observed in ENOS and a simulated subgroup effect present, adjudication would have affected trial conclusions.
conclusionsStroke type at trial entry was diagnosed accurately by local clinicians in ENOS. Adjudication of stroke type by central adjudicators had no measurable effect on trial conclusions. Diagnostic adjudication may be important if diagnosis is complex and a treatment-diagnosis interaction is expected.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.