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. 2021 Sep;10(9):3303-3308.
doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.

Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions

Ajay K Shukla  1 , Ratinder Jhaj  1 , Saurav Misra  1 , Shah N Ahmed  2 , Malaya Nanda  1 , Deepa Chaudhary  3
Affiliations

Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions

Ajay K Shukla et al. J Family Med Prim Care. 2021 Sep.

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.

Keywords: Agreement between scales; Naranjo algorithm; WHO-UMC scale; causality assessment.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Distribution of sampled adverse drug reactions (ADRs) based on causality reported as per the WHO-UMC scale (%)
Figure 2
Figure 2
Distribution of sampled adverse drug reactions (ADRs) based on causality reported as per the Naranjo algorithm
See this image and copyright information in PMC

Comment in

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