ArticleJournal of evaluation in clinical practice2025
Serious Adverse Events: A Replicability and Validation Study of Naranjo Causality Assessment Tool in a Canadian Clinical Setting.
Article in Journal of evaluation in clinical practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
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Who cites it
1 citing paper in PubMed.
- Interleukin-6 Inhibitor-Induced Leukocytoclastic Vasculitis: A Case Report With a Literature Review.Case reports in immunology · 2025Article
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Authors and funding
10 authors.
Funding
Abstract
rationalePatient safety has become a major concern in healthcare today as 5%-10% of patients experience serious adverse events (SAE) during their hospital stay. The causal assessment of SAE is the responsibility of healthcare professionals (HCP), who use their judgment or a standardize tool. Whether those two methods are replicable to provide similar results remains unclear.
objectiveOur aim was to evaluate if causality assessment performed by HCP is replicable when systematically assessed with the Naranjo tool and to validate its performance in Canadian clinical context.
methodsWe performed pilot retrospective cohort study which included patients with SAE admitted to a Quebec hospital in 2021. Twelve SAE were randomly selected, and two reviewers independently assessed their causality using Naranjo tool. Inter-rater reliability among two reviewers and between HCP was evaluated. Along with criterion validity, sensitivity and specificity were calculated for validation study.
resultsWeighted kappa was 0.92 (good inter-rater reliability) where kappa was 0.84 (good agreement between reviewers). No causality assessment by HCP was documented leading to impossibility in computing replicability. The Naranjo tool showed positive monotonic correlation with expert opinion resulting in r
conclusionOur study suggested that Naranjo tool is reliable and valid to be used in a clinical setting and was able to classify all drug products involved in the occurrence of SAE. Larger scale studies need to be conducted in real-time clinical settings to investigate its performance and utility.
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