Development and inter-rater reliability of the Liverpool adverse drug reaction causality assessment tool.
prospective_cohort · Level II
Where this comes from
- Record sourced from PubMed, PMID 22194808.
- Also identified by DOI 10.1371/journal.pone.0028096 and PMC identifier 3237416.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
AIM: To develop and test a new adverse drug reaction (ADR) causality assessment tool (CAT). METHODS: A comparison between seven assessors of a new CAT, formulated by an expert focus group, compared with the Naranjo CAT in 80 cases from a prospective observational study and 37 published ADR case reports (819 causality assessments in total). MAIN OUTCOME MEASURES: Utilisation of causality categories, measure of disagreements, inter-rater reliability (IRR). RESULTS: The Liverpool ADR CAT, using 40 cases from an observational study, showed causality categories of 1 unlikely, 62 possible, 92 probable and 125 definite (1, 62, 92, 125) and 'moderate' IRR (kappa 0.48), compared to Naranjo (0, 100, 172, 8) with 'moderate' IRR (kappa 0.45). In a further 40 cases, the Liverpool tool (0, 66, 81, 133) showed 'good' IRR (kappa 0.6) while Naranjo (1, 90, 185, 4) remained 'moderate'. CONCLUSION: The Liverpool tool assigns the full range of causality categories and shows good IRR. Further assessment by different investigators in different settings is needed to fully assess the utility of this tool.
Medical subject headings
- Adverse Drug Reaction Reporting Systems
- Causality