1. Inter-rater agreement between WHO- Uppsala Monitoring Centre system and Naranjo algorithm for causality assessment of adverse drug reactions.
- Author
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More SA, Atal S, and Mishra PS
- Subjects
- Humans, Female, Male, Adult, Cross-Sectional Studies, Middle Aged, India, Young Adult, World Health Organization, Observer Variation, Aged, Adolescent, Drug-Related Side Effects and Adverse Reactions diagnosis, Drug-Related Side Effects and Adverse Reactions epidemiology, Adverse Drug Reaction Reporting Systems statistics & numerical data, Algorithms, Pharmacovigilance
- Abstract
Determining the causality of Adverse Drug Reactions (ADRs) is essential for management and prevention of future occurrences. The WHO-Uppsala Monitoring Centre (UMC) system is recommended under the Pharmacovigilance Program of India whereas Naranjo's algorithm is commonly utilized by clinicians, but their agreement remains a subject of investigation. This study aims to compare the inter-rater agreement between these two scales for causality assessment of ADRs. In this cross-sectional study, two groups of pharmacovigilance experts were given a set of total 399 anonymized individual case safety reports, collected over six months. The raters were blinded to each other's assessments and applied the WHO-UMC system and Naranjo algorithm to each case independently. Inter-rater agreement was then evaluated utilizing Cohen's kappa. The suspected ADRs were also comprehensively analysed on parameters like age, sex, route of administration, speciality, organ system affected, most common drug categories and individual drugs, outcome of ADRs. Analysis of 399 suspected ADRs revealed that mean age of patients was 36.8 ± 18.0 years, females were more frequently affected, highest proportion of reports were from psychiatry inpatients, seen with antipsychotic drugs, involved the central nervous system, with oral administration, and 91% resolved. On causality assessment by the WHO-UMC system, 53.3% were "Certain" whereas Naranjo's algorithm categorized 96.74% of ADRs as "Probable". Cohen's kappa showed a "Minimal" agreement (0.22) between WHO-UMC and Naranjo system of causality assessment. The considerable lack of agreement between the two commonly employed systems of causality assessment of ADRs warrants further investigation into specific factors influencing the disagreement to improve the accuracy of causality assessments., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)
- Published
- 2024
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