Objective(s): To obtain reliable information about the incidence of adverse drug reactions, and identify potential areas where intervention may reduce the burden of ill-health.
Design: Prospective observational study.
Setting: A large tertiary children's hospital providing general and specialty care in the UK.
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).