Lunara Teles Silva1, Ana Carolina Figueiredo Modesto2, Renato Rocha Martins3, Gabriela Guimarães Bessa1, Flavio Marques Lopes4. 1. Universidade Federal de Goiás, Faculdade de Farmácia, Laboratório de Pesquisa em Ensino e Serviços Farmacêuticos (LaPESF), Goiânia, GO, Brazil. 2. Universidade Federal de Goiás, Hospital das Clínicas, Goiânia, GO, Brazil. 3. Universidade Federal de Goiás, Faculdade de Farmácia, Laboratório de Pesquisa em Ensino e Serviços Farmacêuticos (LaPESF), Goiânia, GO, Brazil; Hospital Geral de Goiânia, Departamento de Farmácia, Goiânia, GO, Brazil. 4. Universidade Federal de Goiás, Faculdade de Farmácia, Laboratório de Pesquisa em Ensino e Serviços Farmacêuticos (LaPESF), Goiânia, GO, Brazil. Electronic address: flaviomarques.ufg@gmail.com.
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.
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.
Keywords:
Child; Criança; Estudos de validação; Medical records; Patient safety; Pharmaceutical preparations; Preparações farmacêuticas; Qualidade do cuidado em saúde; Quality of health care; Registros médicos; Segurança do paciente; Validation studies
Authors: Paulo Henrique Santos Andrade; Amanda Carvalho Barreiros de Almeida; Ana Keilla Santana Dos Santos; Iza Maria Fraga Lobo; Francilene Amaral da Silva; Wellington Barros da Silva Journal: Ther Adv Drug Saf Date: 2020-07-31