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Evaluation of naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury.
BACKGROUNDCausality assessment in hepatotoxicity is challenging. The current standard liver-specific Council for International Organizations of Medical Sciences/Roussel Uclaf Causality Assessment Method scale is complex and difficult to implement in daily practice. The Naranjo Adverse Drug Reactions Probability Scale is a simple and widely used nonspecific scale, which has not been specifically evaluated in drug-induced liver injury.
AIMTo compare the Naranjo method with the standard liver-specific Council for International Organizations of Medical Sciences/Roussel Uclaf Causality Assessment Method scale in evaluating the accuracy and reproducibility of Naranjo Adverse Drug Reactions Probability Scale in the diagnosis of hepatotoxicity.
METHODSTwo hundred and twenty-five cases of suspected hepatotoxicity submitted to a national registry were evaluated by two independent observers and assessed for between-observer and between-scale differences using percentages of agreement and the weighted kappa (kappa(w)) test.
RESULTSA total of 249 ratings were generated. Between-observer agreement was 45% with a kappa(w) value of 0.17 for the Naranjo Adverse Drug Reactions Probability Scale, while there was a higher agreement when using the Council for International Organizations of Medical Sciences/Roussel Uclaf Causality Assessment Method scale (72%, kappa(w): 0.71). Concordance between the two scales was 24% (kappa(w): 0.15). The Naranjo Adverse Drug Reactions Probability Scale had low sensitivity (54%) and poor negative predictive value (29%) and showed a limited capability to distinguish between adjacent categories of probability.
CONCLUSIONThe Naranjo scale lacks validity and reproducibility in the attribution of causality in hepatotoxicity.
Unidad de Hepatología, Servicio de Aparato Digestivo, Hospital Universitario Virgen de la Victoria, Facultad de Medicina, Campus Universitario de Teatinos sn, Málaga, Spain., , , , ,
Alimentary pharmacology & therapeutics 27:9 2008 May pg 780-9
MeSHAdverse Drug Reaction Reporting Systems
Drug-Induced Liver Injury
Drug-Related Side Effects and Adverse Reactions
Liver Function Tests
Severity of Illness Index
Statistics as Topic
Pub Type(s)Journal Article