ABSTRACT
Background The causality assessment of adverse drug reactions (ADRs) remains a challenge, and none of the different available method of causality assessment used for assessing adverse reactions has been universally accepted as the gold standard. Objective To examine the agreement and correlation among three broad approaches for causality assessment of ADRs viz. World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, Naranjo algorithm, and updated Logistic method. Setting ADR monitoring centre (AMC) of a tertiary care teaching hospital in India. Method A total of 230 cases of ADR from April 2017 to August 2017 were retrospectively analyzed by each of these three methods. The agreement among the different methods was calculated by Cohen's kappa (κ), and Spearman's correlation was used to find the correlation among these methods. Main outcome measures Cohen's kappa value and Spearman's correlation coefficient for comparison among the different methods. Results The Cohen's κ used for analyzing the agreement between WHO-UMC system and Naranjo algorithm was 0.45, between WHO-UMC system and updated Logistic method was 0.405, and between Naranjo algorithm and updated Logistic method was 0.606. The Spearman's correlation coefficient was 0.793 for Naranjo algorithm vs. updated Logistic method, 0.735 for WHO-UMC system vs. Naranjo algorithm, and 0.696 for WHO-UMC system vs. updated Logistic method. Conclusion Causality assessment based on objective measurements (scores and probabilities) like updated Logistic method and Naranjo algorithm are less prone to subjective variations compared to the WHO-UMC system which is based on expert judgement.
Subject(s)
Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions/epidemiology , Pharmacovigilance , Adult , Algorithms , Bayes Theorem , Drug-Related Side Effects and Adverse Reactions/diagnosis , Female , Humans , India/epidemiology , Judgment , Logistic Models , Male , Patient Safety , Registries , Reproducibility of Results , Retrospective Studies , Risk Assessment , Risk FactorsABSTRACT
BACKGROUND AND OBJECTIVE: The causality assessment of drug-induced liver injury (DILI) remains a challenge and eagerly awaits the development of reliable hepatotoxicity biomarkers. None of the different available algorithms used for the causality assessment of DILI has been universally accepted as the gold standard. This study was conducted to examine the agreement among different causality assessment scales in reporting DILI. METHODS: The World Health Organization-Uppsala Monitoring Center (WHO-UMC), Naranjo, Roussel Uclaf Causality Assessment Method (RUCAM), Maria & Victorino (M & V) and Digestive Disease Week-Japan (DDW-J) assessment scales were used to compare the causalities in all the reported cases of DILI in our adverse drug reaction (ADR) monitoring centre from January 2014 to June 2017. The probability of the causality assessment was classified as 'definite', 'probable', 'possible' and 'unlikely'. The agreement obtained among the causality assessments was analysed using the weighted kappa (κ w) test. RESULTS: A total of 33 cases of DILI were included in our analyses. Anti-tubercular therapy (ATT) and methotrexate were the drugs that most commonly caused DILI. The overall agreement among the different scales was poor. The best agreement was found between RUCAM and DDW-J scales (κ w: 0.685). CONCLUSION: There were discrepancies among the different causality scales in assessing DILI. This might be due to the different definitions of causality criteria and subjective variability during assessment. A personalised assessment scale incorporating the latest information on specific risk factors and evidence-based criteria for DILI is warranted.
