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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.
García-Cortés M, Lucena MI, Pachkoria K, Borraz Y, Hidalgo R, Andrade RJ, Spanish Group for the Study of Drug-induced Liver Disease (grupo de Estudio para las Hepatopatías Asociadas a Medicamentos, Geham)
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