Serious Adverse Events: A Replicability and Validation Study of Naranjo Causality Assessment Tool in a Canadian Clinical Setting.

ABSTRACT:

Rationale

Patient 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.

Objective

Our 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.

Methods

We 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 asse

SUBMITTER: Pradhan P 

PROVIDER: S-EPMC12022191 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature