Avaliação de gravidade e evitabilidade de reações adversas a medicamentos suspeitas em neonatos: desempenho das ferramentas de Hartwig e Bracken
Introduction: Neonates in neonatal intensive care units (NICUs) are highly susceptible to adverse drug reactions (ADRs) due to the complexity of pharmacotherapy, physiological immaturity, and extensive off-label drug use. Therefore, it is crucial to characterize ADRs in terms of severity and avoi...
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| Formato: | bachelorThesis |
| Idioma: | pt_BR |
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Universidade Federal do Rio Grande do Norte
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| Endereço do item: | https://repositorio.ufrn.br/handle/123456789/53680 |
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| Resumo: | Introduction: Neonates in neonatal intensive care units (NICUs) are highly
susceptible to adverse drug reactions (ADRs) due to the complexity of
pharmacotherapy, physiological immaturity, and extensive off-label drug use.
Therefore, it is crucial to characterize ADRs in terms of severity and avoidability to
ensure the health and safety of neonates. However, the reliability of ADR classification
tools in the NICU context remains insufficiently established. Objective This study
aimed to evaluate the inter-rater reproducibility of tools used to characterize the
severity and avoidability of ADRs in NICUs. Methods: An observational and
prospective study was conducted between January 2019 and December 2020 in a
referral NICU for high-risk pregnancies in Natal, Brazil. The Hartwig tool was employed
for assessing severity, while the Bracken tool was used to evaluate avoidability. Three
experienced clinical pharmacists independently assessed all ADR cases. Inter-rater
reproducibility 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 1,446.0±1,179.3g. The
assessment of ADR severity using the Hartwig tool revealed a significant overall
correlation (overall k = 0.573; 95% CI 0.409-0.737) with an 86.5% agreement rate and
68.3% discordance among raters. However, no statistically significant correlation was
observed for determining avoidability using the Bracken tool (overall k = 0.007; 95%
CI -0.046-0.022), with an inter-rater discordance rate of 83.3%. Conclusion: The
Hartwig tool demonstrates good reproducibility among different evaluators in
determining the severity of ADRs, unlike the Bracken method for assessing
avoidability. |
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