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巴西葡萄牙语版儿科触发工具包适用于测量巴西儿科住院患者不良药物事件的发生情况。

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients.

机构信息

Universidade Federal de Goiás, Faculdade de Farmácia, Laboratório de Pesquisa em Ensino e Serviços Farmacêuticos (LaPESF), Goiânia, GO, Brazil.

Universidade Federal de Goiás, Hospital das Clínicas, Goiânia, GO, Brazil.

出版信息

J Pediatr (Rio J). 2019 Jan-Feb;95(1):61-68. doi: 10.1016/j.jped.2017.10.009. Epub 2017 Dec 29.

Abstract

OBJECTIVE

To describe the process of translation, adaptation, and validation of the Brazilian Portuguese version of the Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital.

METHODS

The validation process for the research instrument was carried out in five steps: (I) translation from English into Brazilian Portuguese by two independent translators; (II) synthesis of the translated versions; (III) adaptation of the triggers to the Brazilian context using a modified Delphi method carried out in two rounds; (IV) application of the research instrument in the review of 240 hospitalizations during 2014; and (V) back-translation from Brazilian Portuguese to English.

RESULTS

The translation step resulted in two versions, which were then synthesized to obtain equivalence within the Brazilian cultural context. The process of adapting the research instrument allowed the inclusion and adaptation of some triggers, as well as the exclusion of others, based on the consensus reached among experts during the Delphi step. The positive predictive value of the research instrument was 13.51%, and the antihistamine trigger presented the highest positive predictive value.

CONCLUSION

The research instrument can be used to track the occurrence of adverse drug events in pediatric patients in Brazilian hospitals. Despite the adjustments made, triggers that were not identified or that had low positive predictive value can suggest the need for additional changes. However, more studies are needed before modifying or removing a trigger.

摘要

目的

描述巴西葡萄牙语版儿科触发工具包(用于测量儿童医院中药物不良事件的工具)的翻译、改编和验证过程。

方法

研究工具的验证过程分五步进行:(I)由两名独立翻译将英文翻译成葡萄牙文;(II)翻译版本的综合;(III)使用两轮改良 Delphi 法对触发因素进行改编,使之适用于巴西国情;(IV)在 2014 年的 240 次住院审查中应用研究工具;(V)从葡萄牙文回译至英文。

结果

翻译步骤产生了两个版本,然后将其综合以获得巴西文化背景下的等效性。改编研究工具的过程允许根据 Delphi 步骤中专家达成的共识,纳入和改编一些触发因素,同时排除其他触发因素。研究工具的阳性预测值为 13.51%,抗组胺药触发因素的阳性预测值最高。

结论

该研究工具可用于追踪巴西医院儿科患者药物不良事件的发生情况。尽管进行了调整,但未识别出或阳性预测值较低的触发因素可能表明需要进行其他更改。但是,在修改或删除触发因素之前,还需要进行更多的研究。

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