development and inter-rater reliability of the liverpool adverse drug reaction causality assessment tool发展和两分的利物浦药物不良反应的可靠性评估因果关系的工具.pdfVIP

Development and Inter-Rater Reliability of the Liverpool Adverse Drug Reaction Causality Assessment Tool 1 2 3 3 2 Ruairi M. Gallagher , Jamie J. Kirkham , Jennifer R. Mason , Kim A. Bird , Paula R. Williamson , 4 5 1 6 Anthony J. Nunn , Mark A. Turner , Rosalind L. Smyth , Munir Pirmohamed * 1 Institute of Child Health, Department of Women’s and Children’s Health, University of Liverpool, Liverpool, United Kingdom, 2 Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom, 3 Research and Development, Alder Hey Children’s NHS Foundation Trust, Liverpool, United Kingdom, 4 Pharmacy, Alder Hey Children’s NHS Foundation Trust, Liverpool, United Kingdom, 5 Department of Women’s and Children’s Health, University of Liverpool, Liverpool, United Kingdom, 6 Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom 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