Assessment of severity and avoidability of adverse drug reactions in neonates: a reproducibility study of the Hartwig tool and LAAT.

IF 2.4 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-01-01 Epub Date: 2024-10-16 DOI:10.1007/s00228-024-03765-8

Ramon Weyler Leopoldino, Luan Carvalho Assunção Rocha, Flávia Evelyn Medeiros Fernandes, Haline Tereza Matias de Lima Costa, Letícia Martins Pereira Vale, Antonio Gouveia Oliveira, Rand Randall Martins

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引用次数: 0

Abstract

Objective: Tools for classifying adverse drug reactions (ADRs) have not yet been validated in the context of the neonatal intensive care unit (NICU). The study aims to investigate the inter-rater reliability of the Hartwig tool and the Liverpool avoidability assessment tool (LAAT) in assessing the severity and avoidability of ADR cases in hospitalized neonates.

Methods: An observational and prospective study was conducted in the NICU of a maternity hospital in Natal, Brazil. The Hartwig tool and LAAT were employed to assess the severity and avoidability of ADRs, respectively. Three experienced clinical pharmacists independently assessed all ADR cases. Inter-rater reliability was measured using Cohen's kappa coefficient (k) with corresponding 95% confidence intervals (CI).

Results: Among 79 ADR cases, the mean gestational age was 29.7 ± 4.4 weeks, and the birth weight averaged 1446.0 ± 1179.3 g. The assessment of ADR severity using the Hartwig tool revealed a significant overall correlation (overall k = 0.573; 95% CI 0.395 to 0.753) with exact agreement (EA) and extreme disagreement (ED) rates between evaluators of 86.5% and 2.5%, respectively. However, no statistically significant correlation was observed for determining avoidability using the LAAT (overall k = 0.017; 95% CI - 0.048 to 0.082), with an EA rate of 83.6% and ED rate of 10.1%.

Conclusion: The Hartwig tool demonstrates good reproducibility among different evaluators in determining the severity of ADRs, unlike the LAAT for assessing avoidability.

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评估新生儿药物不良反应的严重程度和可避免性：哈特维格工具和 LAAT 的重现性研究。

目的：药物不良反应（ADR）分类工具尚未在新生儿重症监护室（NICU）中得到验证。本研究旨在调查哈特维格工具和利物浦可避免性评估工具（LAAT）在评估住院新生儿药物不良反应病例的严重程度和可避免性方面的评分者间可靠性：在巴西纳塔尔一家妇产医院的新生儿重症监护室开展了一项前瞻性观察研究。哈特维格工具和LAAT分别用于评估不良反应的严重性和可避免性。三名经验丰富的临床药剂师独立评估了所有 ADR 病例。使用科恩卡帕系数（k）和相应的 95% 置信区间（CI）测量评分者之间的可靠性：在 79 例 ADR 中，平均胎龄为 29.7 ± 4.4 周，出生体重平均为 1446.0 ± 1179.3 克。使用 Hartwig 工具评估 ADR 严重程度时发现，评估者之间存在显著的总体相关性（总体 k = 0.573；95% CI 0.395 至 0.753），完全一致率（EA）和极端不一致率（ED）分别为 86.5% 和 2.5%。然而，在使用 LAAT 确定可避免性时，未观察到具有统计学意义的相关性（总体 k = 0.017；95% CI - 0.048 至 0.082），EA 率为 83.6%，ED 率为 10.1%：哈特维格工具与 LAAT 评估可避免性不同，不同评估者在确定 ADR 严重程度时具有良好的可重复性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.