ArticlePloS one2017
Imputation of adverse drug reactions: Causality assessment in hospitals.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
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Who cites it
27 citing papers in PubMed.
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- Attribution of causality in Stevens-Johnson syndrome/toxic epidermal necrolysis.The ocular surface · 2025Review
- Article
- Age-stratified pharmacovigilance of azithromycin: a multimethod signal detection analysis in the FAERS database.Journal of pharmaceutical policy and practice · 2025Article
- Drug-Related Glomerular Phenotypes: A Global Pharmacovigilance Perspective.Journal of clinical medicine · 2024Article
- Antiseizure adverse drug reaction and associated factors among epileptic patients at Jimma Medical Center: a prospective observational study.Scientific reports · 2024Observational
- Performance of triggers in detecting hospitalizations related to drug-induced respiratory disorders in older adults: A pilot cross-sectional study.Clinics (Sao Paulo, Brazil) · 2024Article
- Effectiveness of Antiseizure Medication Triple Therapy in Patients With Glioma With Refractory Epilepsy: An Observational Cohort Study.Neurology · 2023Observational
- Detection of Adverse Drug Reactions in COVID-19 Hospitalized Patients in Saudi Arabia: A Retrospective Study by ADR Prompt Indicators.Healthcare (Basel, Switzerland) · 2023Article
- Adverse drug event detection using natural language processing: A scoping review of supervised learning methods.PloS one · 2023Article
- Leech Application-related Upper Gastrointestinal Bleeding: A Case Report.Bulletin of emergency and trauma · 2023Article
- Effectiveness of Antiseizure Medication Duotherapies in Patients With Glioma: A Multicenter Observational Cohort Study.Neurology · 2022Observational
- Causality and avoidability of adverse drug reactions of antibiotics in hospitalized children: a cohort study.International journal of clinical pharmacy · 2021Article
- Causality assessment of adverse drug reactions by applying a global introspection method in a high complexity hospital.Exploratory research in clinical and social pharmacy · 2021Article
- First-line antiepileptic drug treatment in glioma patients with epilepsy: Levetiracetam vs valproic acid.Epilepsia · 2021Observational
- Utilization of the Naranjo scale to evaluate adverse drug reactions at a free-standing children's hospital.PloS one · 2021Article
- Descriptive study of adverse drug reactions in a tertiary care pediatric hospital in México from 2014 to 2017.PloS one · 2020Article
- Adverse Drug Events and Contributing Factors Among Hospitalized Adult Patients at Jimma Medical Center, Southwest Ethiopia: A Prospective Observational Study.Current therapeutic research, clinical and experimental · 2020Article
- Adverse drug reaction causality assessment tools for drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: room for improvement.European journal of clinical pharmacology · 2019Article
- New Insights in Computational Methods for Pharmacovigilance:International journal of environmental research and public health · 2019Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
objectivesDifferent algorithms have been developed to standardize the causality assessment of adverse drug reactions (ADR). Although most share common characteristics, the results of the causality assessment are variable depending on the algorithm used. Therefore, using 10 different algorithms, the study aimed to compare inter-rater and multi-rater agreement for ADR causality assessment and identify the most consistent to hospitals.
methodsUsing ten causality algorithms, four judges independently assessed the first 44 cases of ADRs reported during the first year of implementation of a risk management service in a medium complexity hospital in the state of Sao Paulo (Brazil). Owing to variations in the terminology used for causality, the equivalent imputation terms were grouped into four categories: definite, probable, possible and unlikely. Inter-rater and multi-rater agreement analysis was performed by calculating the Cohen´s and Light´s kappa coefficients, respectively.
resultsNone of the algorithms showed 100% reproducibility in the causal imputation. Fair inter-rater and multi-rater agreement was found. Emanuele (1984) and WHO-UMC (2010) algorithms showed a fair rate of agreement between the judges (k = 0.36). INTERPRETATION &
conclusionsAlthough the ADR causality assessment algorithms were poorly reproducible, our data suggest that WHO-UMC algorithm is the most consistent for imputation in hospitals, since it allows evaluating the quality of the report. However, to improve the ability of assessing the causality using algorithms, it is necessary to include criteria for the evaluation of drug-related problems, which may be related to confounding variables that underestimate the causal association.
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