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Causality Assessment Method (causality + assessment_method)
Selected AbstractsEvaluation of Naranjo Adverse Drug Reactions Probability Scale in causality assessment of drug-induced liver injuryALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2008M. GARCÍA-CORTÉS Summary Background, Causality 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. Aim, To 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. Methods, Two 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 (,w) test. Results, A total of 249 ratings were generated. Between-observer agreement was 45% with a ,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%, ,w: 0.71). Concordance between the two scales was 24% (,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. Conclusion, The Naranjo scale lacks validity and reproducibility in the attribution of causality in hepatotoxicity. [source] The predictors of complications in patients with drug-induced liver injury caused by antimicrobial agentsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2010S. TREEPRASERTSUK Aliment Pharmacol Ther,31, 1200,1207 Summary Background, Antimicrobials are the leading cause of idiosyncratic drug-induced liver injury in most series. Aim, To determine the incidence and the predictors of complications in patients with drug-induced liver injury caused by antimicrobial agents requiring hospitalization. Methods, Medical records of patients with drug-induced liver injury caused by antimicrobial agents were identified by ICD-10, for the period between 2002 and 2006. Clinical information and blood tests during hospitalization were recorded. The causality assessment of drug-induced liver injury was determined by the Roussel UCLAF causality assessment method (RUCAM) scale. Results, Of 47 594 in-patient admissions per year, the annual incidence of drug-induced liver injury was 0.03%. Male: female ratio was 7:3 with a median age of 47 years. Eighty reactions of drug-induced liver injury were caused by anti-tuberculosis drugs (85%) and by antibiotics (15%). The median (IQR) of RUCAM scale was 6 (5,8). A total of 36% had HIV infection and 9% of patients had diabetes mellitus. Median (IQR) duration of hospitalization was 9 (5,15) days. Serious complications and death were found in 27.5% and 26%, respectively. By a multivariable logistic analysis, the presence of jaundice was found to be significantly associated with an unfavourable outcome. Conclusion, Although rare, antimicrobial agents-related drug-induced liver injury requiring hospitalization has a high mortality rate. The presence of jaundice predicts poor outcome. [source] Inter-expert agreement of seven criteria in causality assessment of adverse drug reactionsBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 4 2007Yannick Arimone What is already known about this subject ,,In pharmacovigilance, many methods have been proposed for causality assessment of adverse drug reactions. ,,Expert judgement is commonly used to evaluate the causal relationship between a drug treatment and the occurrence of an adverse event. This form of judgement relies either explicitly or implicitly on causality criteria. What this study adds ,,Our study compares the judgements of five senior experts using global introspection about drug causation and seven causality criteria on a random set of putative adverse drug reactions. ,,Even if previous publications have shown poor agreement between experts using global introspection, few have compared judgements of well trained pharmacologists, familiar with using a standardized causality assessment method. Aims To evaluate agreement between five senior experts when assessing seven causality criteria and the probability of drug causation. Methods A sample of 31 adverse event-drug pairs was constituted. For each pair, five experts separately assessed (i) the probability of drug causation, which was secondarily divided into seven causality levels: ruled out (0,0.05), unlikely (0.06,0.25), doubtful (0.26,0.45), indeterminate (0.46,0.55), plausible (0.56,0.75), likely (0.76,0.95), and certain (0.96,1); and (ii) seven causality criteria. To test discrepancies between experts, the kappa index was used. Results The agreement of the five experts was very poor (kappa = 0.05) for the probability of drug causation. Among the seven levels of causality, only ,doubtful' showed a significant rate of agreement (kappa = 0.32, P < 0.001). For all criteria, the kappa index was significant except for the item ,risk(s) factor(s)' (kappa = 0.09). Agreement between experts was good (0.64, P < 0.001) only for the criterion ,reaction at site of application or toxic plasma concentration of the drug or validated test'. However, the rate of agreement with kappa indices of the causality criteria ranged from 0.12 to 0.38. Conclusions This study confirms that in the absence of an operational procedure, agreement between experts is low. This should be considered when designing a causality assessment method. In particular, criteria inducing a low level of agreement should have their weight reduced. [source] | ||||||||||