Cross-cultural adaptation, validation and reliability of the Medication Safety Thermometer tool for use in Brazil.

OBJECTIVES: to perform cross-cultural adaptation, face and content validation and reliability analysis of the Medication Safety Thermometer tool for use in Brazil. METHODS: the process of cross-cultural adaptation and validation followed the stages of translation, synthesis of translations, back-translation, content validation performed by experts, and face validation through pre-testing. Reliability was determined by calculating the Kappa coefficient. RESULTS: the two translated versions were synthesized into a single version, which was back-translated and showed no divergences. The expert committee judged the adapted tool as equivalent, reaching a Content Validity Index higher than 0.8. The mean global understanding was 1.82, demonstrating face validity. The assessed items had Kappa coefficient greater than 0.61, showing agreement between observers. CONCLUSIONS: the cross-cultural adaptation of the tool was performed following an established methodology. The adapted tool showed inter-rater reliability and validity for use in Brazil.

Probability of Target Attainment of Tobramycin Treatment in Acute and Chronic Pseudomonas aeruginosa Lung Infection Based on Preclinical Population Pharmacokinetic Modeling.

Biofilms and infectious process may alter free antimicrobial concentrations at the site of infection. Tobramycin (TOB), an aminoglycoside used to treat lung infections caused by Pseudomonas aeruginosa, binds to alginate present in biofilm extracellular matrix increasing its minimum inhibitory concentration (MIC). This work aimed to investigate the impact of biofilm-forming P. aeruginosa infection on TOB lung and epithelial lining fluid (ELF) penetration, using microdialysis, and to develop a population pharmacokinetic (popPK) model to evaluate the probability of therapeutic target attainment of current dosing regimens employed in fibrocystic and non-fibrocystic patients. The popPK model developed has three compartments including the lung. The ELF concentrations were described by a penetration factor derived from the lung compartment. Infection was a covariate in lung volume (V3) and only chronic infection was a covariate in central volume (V1) and total clearance (CL). Simulations of the recommended treatments for acute and chronic infection achieved >90% probability of target attainment (PTA) in the lung with 4.5 mg/kg q24h and 11 mg/kg q24h, respectively, for the most prevalent P. aeruginosa MIC (0.5 mg/mL). The popPK model was successfully applied to evaluate the PTA of current TOB dosing regimens used in the clinic, indicating the need to investigate alternative posology.

Cross-cultural adaptation, validation and reliability of the Medication Safety Thermometer tool for use in Brazil / Adaptación transcultural, validez y confiabilidad de la herramienta Medication Safety Thermometer para uso en Brasil / Adaptação transcultural, validação e confiabilidade da ferramenta Medication Safety Thermometer para uso no Brasil

ABSTRACT Objectives: to perform cross-cultural adaptation, face and content validation and reliability analysis of the Medication Safety Thermometer tool for use in Brazil. Methods: the process of cross-cultural adaptation and validation followed the stages of translation, synthesis of translations, back-translation, content validation performed by experts, and face validation through pre-testing. Reliability was determined by calculating the Kappa coefficient. Results: the two translated versions were synthesized into a single version, which was back-translated and showed no divergences. The expert committee judged the adapted tool as equivalent, reaching a Content Validity Index higher than 0.8. The mean global understanding was 1.82, demonstrating face validity. The assessed items had Kappa coefficient greater than 0.61, showing agreement between observers. Conclusions: the cross-cultural adaptation of the tool was performed following an established methodology. The adapted tool showed inter-rater reliability and validity for use in Brazil.

RESUMEN Objetivos: realizar adaptación transcultural, validez facial y contenido y análisis de confiabilidad de la herramienta Medication Safety Thermometer para uso en Brasil. Métodos: el proceso de adaptación transcultural y validez siguió las etapas de traducción, síntesis de las traducciones, retro-traducción, validez de contenido realizada por especialistas y validez facial mediante el pretest. La confiabilidad fue determinada por el cálculo del coeficiente de Kappa. Resultados: las dos versiones traducidas fueron sintetizadas en una única versión, que fue retro-traducida y no demostró divergencias. El comité de expertos juzgó la herramienta adaptada como equivalente, alcanzando Índice de Validez de Contenido mayor que 0,8. La mediana de comprensión global fue de 1,82, demostrando validez facial. Los ítems evaluados presentaron coeficiente de Kappa mayor que 0,61, evidenciando concordancia entre observadores. Conclusiones: la adaptación transcultural de la herramienta fue realizada siguiendo metodología establecida. La herramienta adaptada mostró confiabilidad entre observadores y validez para utilización en Brasil.

RESUMO Objetivos: realizar adaptação transcultural, validação de face e conteúdo e análise da confiabilidade da ferramenta Medication Safety Thermometer para uso no Brasil. Métodos: o processo de adaptação transcultural e validação seguiu as etapas de tradução, síntese das traduções, retrotradução, validação de conteúdo realizada por especialistas e validação de face mediante o pré teste. A confiabilidade foi determinada pelo cálculo do coeficiente de Kappa. Resultados: as duas versões traduzidas foram sintetizadas em uma única versão, que foi retrotraduzida e não demonstrou divergências. O comitê de experts julgou a ferramenta adaptada como equivalente, alcançando Índice de Validade de Conteúdo maior que 0,8. A média de compreensão global foi de 1,82, demonstrando validade de face. Os itens avaliados apresentaram coeficiente de Kappa maior que 0,61, evidenciando concordância entre observadores. Conclusões: a adaptação transcultural da ferramenta foi realizada seguindo metodologia estabelecida. A ferramenta adaptada mostrou confiabilidade entre observadores e validade para utilização no Brasil.