CAUSALITY ASSESSMENT OF ADVERSE REACTIONS TO DRUGS .2. AN ORIGINAL MODEL FOR VALIDATION OF DRUG CAUSALITY ASSESSMENT METHODS - CASE-REPORTSWITH POSITIVE RECHALLENGE

Standards are lacking for validation of drug causality assessment meth ods. An original model is proposed using a positive rechallenge as an external standard. This model was used to validate the novel causality assessment method (RUCAM) described in the previous article (Part I; J Clin Epidemiol 1993; 46: 1323). Seventy seven reports of drug-induce d acute liver injuries with positive rechallenge were collected from t he medical literature and divided into 49 cases and 28 controls. The R UCAM was applied to information obtained prior to readministration. Th e score was significantly higher (p < 10(-4)) in cases than in control s with high levels of sensitivity, specificity and predictive values. It is concluded that (1) adverse drug reaction reports with a positive rechallenge can provide a standard for validation of causality assess ment methods, (2) RUCAM applied to drug-induced liver injuries has bee n validated.