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Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions
Abstract
Background: The Pharmacovigilance Program of India recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while many clinicians prefer the Naranjo algorithm for its simplicity. In the present study, we assessed agreement between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. Materials and Methods: In this study, 842 individual case safety reports were randomly selected from 1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary healthcare Institute in Central India between 2016 and 2018. Two well-trained independent groups performed the causality assessment. One group performed a causality assessment of the 842 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. Results: Cohen's kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. “No” agreement was found between the two scales {Kappa statistic with 95% confidence interval = 0.048 ( P < 0.001)}. Conclusion: There was no agreement found between the WHO-UMC criteria and the Naranjo algorithm in our study.
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Various studies have shown poor agreement between the Naranjo and WHO-UMC scales when assessing adverse drug reactions.
“Various studies have shown poor agreement between the two scales when assessing ADRs”
From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [29]
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A method for estimating the probability of adverse drug reactions
Naranjo, C. A., Busto, U., Sellers, E. M., Sandor, P., Ruiz, I., Roberts, E. A., Janecek, E., Domecq, C., & Greenblatt, D. J. (1981) · Clinical Pharmacology and Therapeutics · doi:10.1038/clpt.1981.154 · Cited by 11,914 · cited 1×
“The most commonly available criteria used worldwide are the Naranjo algorithm [Table 2a and 2b].[9,10] The third category of causality assessment methods is the probabilistic methods.”
MethodSample-size calculations for Cohen's kappa.
Cantor, A. B. (1996) · Psychological Methods · doi:10.1037/1082-989x.1.2.150 · Cited by 240 · cited 2×
“21 (from previous studies), using the formula given by Cantor,[12] the calculated minimum required sample size for the study was 830 ADR cases.”
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Research works printed but not linked: 16
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Cited by
Sorted by citations
Methods for causality assessment of idiosyncratic drug‐induced liver injury
García‐Cortés, M., Matilla‐Cabello, G., & Lucena, M. I. (2025) · Liver International · doi:10.1111/liv.16083 · Cited by 15
Metadata
- Authors
- Shukla, A. K., Jhaj, R., Misra, S., Ahmed, S. N., Nanda, M., & Chaudhary, D.
- Venue
- Journal of Family Medicine and Primary Care
- Published
- 2021-09
- Volume
- 10
- Issue
- 9
- Pages
- 3303-3308
- ISSN
- 2249-4863
- PMC
- PMC8565125
- Cited by
- 93
- References
- 2
- Language
- en
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