Causality assessment of adverse drug reactions in neonates: a comparative study between Naranjo's algorithm and Du's tool

Leopoldino, Ramon Weyler Duarte; Oliveira, Lucas Ferro Antunes de; Fernandes, Flavia Evelyn Medeiros; Costa, Haline Tereza Matias de Lima; Vale, Letícia Martins Pereira; Oliveira, António Gouveia; Martins, Rand Randall

doi:10.1007/s11096-023-01595-9

Cited by 2 publications

(1 citation statement)

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“…Previous studies using the Naranjo algorithm and WHO-UMC scale revealed agreement rates of 43–93% [ 18 – 20 ] and 24–73% [ 17 , 20 , 21 ], respectively, with kappa coefficients of 0.14–0.86 [ 18 – 20 , 22 ] and 0.11–0.71 [ 17 , 20 , 21 ], respectively. The results vary on the basis of study conditions, including the subject of the evaluation.…”

Section: Discussionmentioning

confidence: 98%

Causality Assessment Between Drugs and Fatal Cerebral Haemorrhage Using Electronic Medical Records: Comparative Evaluation of Disease-Specific and Conventional Methods

Ohta,

Miyawaki,

Yokota

et al. 2024

Drugs - Real World Outcomes

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Introduction A new algorithm for causality assessment of drugs and fatal cerebral haemorrhage (ACAD-FCH) was published in 2021. However, its use in clinical practice has not been verified. Objectives This study aimed to explore the practical value of the ACAD-FCH when applying information available in clinical practice. Methods The medical records of patients who died at the University of Tokyo Hospital in 2020 were reviewed, and cases with intracranial haemorrhage were selected. Two evaluators independently assessed these cases using three methods (the ACAD-FCH, Naranjo algorithm, and WHO-UMC scale). The number of ‘Yes’, ‘No’, and ‘No information/Do not know’ responses to each question by both evaluators were summed and compared. Inter-rater reliability was evaluated for each method using agreement rates and kappa coefficients with 95% confidence intervals (CI). Results Among 316 deaths, 24 cases with intracranial haemorrhage were evaluated. The proportion of ‛No information/Do not know’ responses for each question was 35.6% (95% CI 31.4–40.6%) for the ACAD-FCH and 66.9% (95% CI 62.5–71.1%) for the Naranjo algorithm. The respective agreement rates and kappa coefficients were 0.917 (0.798–1.00) and 0.867 (0.675–1.00) for the ACAD-FCH, 0.708 (0.512–0.904) and 0.139 (−0.236 to 0.513) for the Naranjo algorithm, and 0.50 (0.284–0.716) and 0.326 (0.110–0.541) for the WHO-UMC scale, respectively. Conclusion Our findings suggest the utility of the ACAD-FCH when assessing death cases with intracranial haemorrhage. However, larger studies including intra-rater assessments are warranted for further validation of this algorithm. Supplementary Information The online version contains supplementary material available at 10.1007/s40801-023-00413-y.

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