Validation of the Brazilian Version of the Modified Scale for Delineating Advanced Practice Nursing Roles.

OBJECTIVES: to validate the Brazilian version of the Modified Scale for Delineating Advanced Practice Nursing Roles. METHODS: this was a methodological study for the clinical validation of an instrument, conducted with 207 nurses working in primary care. Exploratory and confirmatory factor analysis, Cronbach's alpha test, and z-test for proportion comparison were used. RESULTS: the internal reliability of the scale was 0.944, with alpha greater than 0.80 in most domains, except for Education (0.786). In the exploratory factor analysis, considering the criterion of eigenvalue greater than one, eight factors were identified, explaining 79.38% of the variance. In the comparison of proportions, the adequate responses (≥ 2) in the domain of Comprehensive Direct Care, in both analyzed groups, were statistically equal. This domain had the highest score of adequate responses, followed by Education and Systems Support. Insufficient scoring was observed in the domains of Publication and Professional Leadership. CONCLUSIONS: the instrument demonstrated stability and reliability to be used in the evaluation of advanced nursing practice.

Tuberculosis preventive treatment in newborns.

OBJECTIVE: To describe the reported cases of newborns subjected to tuberculosis preventive treatment (TPT) in the state of Paraná, Brazil, and to evaluate the safety and effectiveness in preventing the progression of TB disease in this population. METHOD: Observational, descriptive case series, with secondary data. The characteristics of the participants were analyzed from the information systems of preventive treatment of TB (of Paraná), between 2009 and 2016. To evaluate which children had developed tuberculosis later or died, we used the data from the information systems of TB (in Brazil), and mortality (in Paraná), covering the years 2009 to 2018. RESULTS: A total of 24 children underwent TPT with the age at treatment onset ranging from 0 to 87 days (median: 23 days). In 95.8 %, the exposure occurred at home, and in 33.3 % of cases, the mother was the source of the infection. A total of 20.8 % of the children tested positive for tuberculosis test at 3 months of age, 83.3 % completed treatment, and 2 experienced adverse events (gastrointestinal issues). No children developed TB or died during the minimum of a 2-year evaluation period through the official databases. CONCLUSIONS: In this case series, the adherence to the plan was high, with few adverse events and 100 % protection against infection.

Validation of the Brazilian Version of the Modified Scale for Delineating Advanced Practice Nursing Roles / Validación de la Versión Brasileña de la Escala Modificada de Delimitación de la Función del Enfermero de Prácticas Avanzadas / Validação da Versão Brasileira da Escala Modificada de Delineamento da Função de Enfermeiro de Práticas Avançadas

ABSTRACT Objectives: to validate the Brazilian version of the Modified Scale for Delineating Advanced Practice Nursing Roles. Methods: this was a methodological study for the clinical validation of an instrument, conducted with 207 nurses working in primary care. Exploratory and confirmatory factor analysis, Cronbach's alpha test, and z-test for proportion comparison were used. Results: the internal reliability of the scale was 0.944, with alpha greater than 0.80 in most domains, except for Education (0.786). In the exploratory factor analysis, considering the criterion of eigenvalue greater than one, eight factors were identified, explaining 79.38% of the variance. In the comparison of proportions, the adequate responses (≥ 2) in the domain of Comprehensive Direct Care, in both analyzed groups, were statistically equal. This domain had the highest score of adequate responses, followed by Education and Systems Support. Insufficient scoring was observed in the domains of Publication and Professional Leadership. Conclusions: the instrument demonstrated stability and reliability to be used in the evaluation of advanced nursing practice.

RESUMEN Objetivos: validar la Escala Modificada de Delimitación de la Función del Enfermero de Prácticas Avanzadas, versión brasileña. Métodos: estudio metodológico de validación clínica de un instrumento, realizado con 207 enfermeros activos en la atención primaria. Se utilizaron análisis factorial exploratorio y confirmatorio, prueba alfa de Cronbach y prueba z para la comparación de proporciones. Resultados: la fiabilidad interna de la escala fue de 0,944, y el alfa fue mayor que 0,80 en la mayoría de los dominios, excepto en Educación (0,786). En el análisis factorial exploratorio, considerando el criterio de autovalor mayor que uno, se identificaron ocho factores, explicando el 79,38% de la varianza. En la comparación de proporciones, las respuestas suficientes (≥ 2) en el dominio de Cuidados Integrales Directos, en ambos grupos analizados, fueron estadísticamente iguales. Este dominio tuvo la mayor puntuación de respuestas suficientes, seguido por Educación y Apoyo de Sistemas. Se observó una puntuación insuficiente en los dominios de Publicación y Liderazgo Profesional. Conclusiones: el instrumento demostró estabilidad y fiabilidad para ser utilizado en la evaluación de la práctica avanzada de enfermería.

RESUMO Objetivos: validar a Escala Modificada de Delineamento da Função do Enfermeiro de Práticas Avançadas, versão brasileira. Métodos: estudo metodológico de validação clínica de instrumento, realizado com 207 enfermeiros atuantes na atenção primária. Utilizaram-se análise fatorial exploratória e confirmatória, teste alfa de Cronbach e teste z para comparação de proporções. Resultados: a confiabilidade interna da escala foi de 0,944, e o alfa maior que 0,80 na maioria dos domínios, exceto Educação (0,786). Na análise fatorial exploratória, considerando o critério do autovalor maior que um, identificaram-se oito fatores, explicando 79,38% da variância. Na comparação de proporções, as respostas suficientes (≥ 2) no domínio Cuidados Abrangentes Diretos, em ambos os grupos analisados, foram estatisticamente iguais. Esse domínio teve a maior pontuação de respostas suficientes, seguido por Educação e Suporte de Sistemas. Pontuação insuficiente foi observada nos domínios Publicação e Liderança Profissional. Conclusões: o instrumento demonstrou estabilidade e confiabilidade para ser utilizado na avaliação da prática avançada de enfermagem.

Réplica à Carta às Editoras de Autoria de Pablo Salomón Montes-Arcón / Reply to the Letter to the Editors by Pablo Salomón Montes-Arcón / Respuesta a la Carta a las Editoras por Autoria de Pablo Salomón Montes-Arcón

Réplica à Carta às Editoras de Autoria de Pablo Salomón Montes-Arcón.

Perfil Clínico-Epidemiológico do Câncer Colorretal na Região Oeste do Paraná, Brasil, 2016-2018 / Clinical and Epidemiological Profile of Colorectal Cancer in Paraná's Western Region, Brazil, 2016-2018 / Perfil Clínico-Epidemiológico de lo Cáncer Colorrectal en la Región Oeste de Paraná, Brasil, 2016-2018

Introdução: O câncer colorretal é a neoplasia mais frequente do trato gastrointestinal, sendo a segunda principal causa de morte por câncer no mundo. Objetivo: Traçar um perfil clínico-epidemiológico do câncer colorretal na Região Oeste do Paraná (Brasil), entre 2016 e 2018. Método: Estudo observacional analítico do tipo transversal, construído a partir da análise de resultados de exames anatomopatológicos, realizados entre 2016 a 2018. Realizaram-se análises por estatística descritiva, teste de associação qui-quadrado e U de Mann-Whitney. Adotou-se nível de significância de 5%. Resultados: A análise de 509 laudos positivos para câncer colorretal permitiu identificar o predomínio de pacientes do sexo masculino e a idade média de diagnóstico de 62 anos. A malignidade mostrou-se mais incidente na faixa etária de 61 a 70 anos (29,9%), e considerável número de casos ocorreu em pacientes abaixo de 50 anos (19,6%). Houve predomínio em cólon esquerdo e do tipo histológico adenocarcinoma infiltrativo moderadamente diferenciado. Verificou-se associação entre topografia da doença e sexo, com maior predominância do sexo feminino para tumores do cólon direito e do sexo masculino para tumores do cólon esquerdo (p=0,0081). Conclusão: A partir deste estudo, delineia-se um perfil clínico-epidemiológico do câncer colorretal na Região Oeste do Paraná, com maior incidência da doença em homens, sexagenários, além de predomínio de tumores em cólon esquerdo e do tipo adenocarcinoma infiltrativo moderadamente diferenciado. Tais achados são relevantes considerando a possibilidade de aplicação assertiva de protocolos internacionais de rastreio do câncer nessa população

Introduction: The colorectal cancer is the most frequent neoplasm of the gastrointestinal tract and the second cause of cancer related death. Objective: To design a clinical and epidemiological profile of the colorectal cancer at the Western Region of the Paraná State from 2016 to 2018. Method: Analytical cross-sectional observational study based on the evaluation of the results of anatomopathological exams, between 2016 and 2018, at a regional specialized center. Analyses were performed using descriptive statistics, chi-square test for association and Mann-Whitney U test. A significance level of 5% was adopted. Results: The analysis of 509 positive anatomopathological reports of colorectal cancer allowed to identify the predominance of male patients and mean age at diagnosis of 62 years. The malignancy was more incident in patients between 61 and 70 years of age (29.9%). A considerable number of cases was found in patients younger than 50 years (19.6%). The disease was predominant at the left colon, of the type moderately differentiated infiltrating adenocarcinoma according to the histological classification. Association between the tumor topography and sex was found, with predominance of females for the right colon and males for the left colon (p=0.0081). Conclusion: This study designed the colorectal cancer clinical and epidemiological profile at Paraná's Western Region. The disease affects more males, older than 60 years of age, mostly with moderately differentiated infiltrative adenocarcinoma at the left colon. These findings are relevant considering the possibility of applying international cancer screening protocols in this population.

Introducción: El cáncer colorrectal es la neoplasia más frecuente del tracto gastrointestinal y la segunda causa de muerte por cáncer a nivel mundial. Objetivo: Trazar un perfil clínico-epidemiológico del cáncer colorrectal en el Oeste de Paraná (Brasil), entre 2016 y 2018. Método: Estudio observacional analítico transversal realizado con los análisis de resultados de exámenes anatomopatológicos entre 2016 a 2018. Se realizaron análisis mediante estadísticas descriptivas, prueba de asociación chi-cuadrado y U de MannWhitney. Se adoptó nivel de significación del 5%. Resultados: Entre los 509 informes positivos para cáncer colorrectal, el 52,8% de los pacientes eran del sexo masculino y tenían promedio de edad de diagnóstico de 62 años. El cáncer fue más frecuente en el grupo de 61 a 70 años (29,9%) y un número significativo de casos se presentó en pacientes menores de 50 años (19,6%). Predominó la enfermedad de colon izquierdo y del tipo histológico de adenocarcinoma infiltrante moderadamente diferenciado. Fue encontrado asociación entre la topografía y el sexo, con mayor predominio del sexo femenino para los tumores de colon derecho y del sexo masculino para los tumores de colon izquierdo (p=0,0081). Conclusión: Se elabora un perfil clínico-epidemiológico del cáncer colorrectal en la región Oeste de Paraná, con mayor incidencia en el sexo masculino, edad de 60 años, predominio de tumores en el colon izquierdo y del tipo adenocarcinoma infiltrante moderadamente diferenciado. Estos puntos son relevantes considerando la posibilidad de aplicación asertiva de protocolos internacionales de rastreo del cáncer en esta población.

Incidência de câncer de mama em trabalhadoras agrícolas do Paraná / Incidence of breast cancer in female agricultural workers in Paraná / Incidencia de cáncer de mama en trabajadoras agrícolas de Paraná

É crescente, nas últimas duas décadas, o número de estudos brasileiros sobre a incidência do câncer de mama, contudo, ainda há carência de trabalhos que avaliem este indicador em populações agrícolas. Objetivou-se analisar a incidência de câncer de mama feminino em trabalhadoras agrícolas residentes no estado do Paraná, no período de 2003 a 2018. Foi realizado um estudo ecológico, exploratório, transversal, constituído pelos casos novos de mulheres diagnosticadas com câncer de mama notificados no Registro Hospitalar de Câncer, entre 2003 e 2018. Calculou-se a taxa de incidência dos novos casos de câncer de mama, usando como referência o número de trabalhadoras agrícolas registradas na Relação Anual de Informações Sociais (RAIS). A regressão linear simples foi utilizada para avaliar as variações anuais da taxa, com intervalo de confiança de 95% (IC95%). E ainda, foram estimadas as Razão de Chances ou Odds Ratio (OR) (IC95%) de ocorrência do agravo para esse grupo ocupacional. A taxa de incidência variou de 136,61 casos por 100 mil trabalhadoras agrícolas em 2003 a 1.225,49/100 mil em 2018. Houve acréscimo significativo de 0,014 casos/100 mil a cada ano (p<0,001) ao longo dos 16 anos da série temporal. As trabalhadoras agrícolas tiveram, em todo o período, maiores chances de desenvolver câncer de mama, quando comparadas com trabalhadoras de outros setores (OR 14,85, IC95% 12,70 - 17,36 em 2018). Conclui-se que a incidência do câncer de mama em trabalhadoras agrícolas é significativa no Paraná e que, ser estar empregada neste setor, aumentou significativamente as chances de desenvolver câncer de mama. A partir desses dados, espera-se auxiliar na elaboração de políticas, orientando prioridades e ações de redução da incidência e mortalidade deste agravo, contribuindo com o alcance da meta 3 "saúde e bem estar' dos Objetivos do Desenvolvimento Sustentável (ODS).

In the last two decades, the number of Brazilian studies on the incidence of breast cancer has been increasing; however, there is still a lack of studies that evaluate this indicator in agricultural populations. We aimed to analyze the incidence of female breast cancer in agricultural workers residing in the state of Paraná, in the period from 2003 to 2018. An ecological, exploratory, cross-sectional study was conducted, consisting of the new cases of women diagnosed with breast cancer notified in the Hospital Cancer Registry, between 2003 and 2018. The incidence rate of new cases of breast cancer was calculated, using as reference the number of female agricultural workers registered in the Annual Social Information Report (RAIS). Simple linear regression was used to evaluate the annual variations of the rate, with a 95% confidence interval (95% CI). We also estimated the Odds Ratio (OR) (95%CI) of occurrence of the grievance for this occupational group. The incidence rate ranged from 136.61 cases per 100,000 female agricultural workers in 2003 to 1,225.49/100,000 in 2018. There was a significant increase of 0.014 cases/100 thousand each year (p<0.001) over the 16 years of the time series. Female agricultural workers had higher odds of developing breast cancer over the entire period compared to female workers in other sectors (OR 14.85, 95% CI 12.70 - 17.36 in 2018). It is concluded that the incidence of breast cancer in female agricultural workers is significant in Paraná and that being a worker in this sector, significantly increases the chances of developing breast cancer. From these data, it is expected to assist in policymaking, guiding priorities and actions to reduce the incidence and mortality of this grievance, contributing to the achievement of goal 3 'health and well-being' of the Sustainable Development Goals (SDGs).

En las últimas dos décadas, el número de estudios brasileños sobre la incidencia de cáncer de mama ha ido en aumento, sin embargo, todavía hay una falta de estudios que evalúen este indicador en poblaciones agrícolas. Tuvimos como objetivo analizar la incidencia de cáncer de mama femenino en trabajadoras agrícolas residentes en el estado de Paraná, en el período de 2003 a 2018. Se realizó un estudio ecológico, exploratorio, transversal, constituido por los casos nuevos de mujeres con diagnóstico de cáncer de mama notificados en el Registro Hospitalario de Cáncer, entre 2003 y 2018. Se calculó la tasa de incidencia de nuevos casos de cáncer de mama, tomando como referencia el número de trabajadoras agrarias registradas en el Informe Anual de Información Social (RAIS). Se utilizó regresión lineal simple para evaluar las variaciones anuales de la tasa, con un intervalo de confianza del 95% (IC 95%). También se estimó la Odds Ratio (OR) (IC 95%) de ocurrencia del agravio para este grupo ocupacional. La tasa de incidencia osciló entre 136,61 casos por 100.000 trabajadoras agrarias en 2003 y 1.225,49/100.000 en 2018. Hubo un aumento significativo de 0,014 casos/100 mil cada año (p<0,001) a lo largo de los 16 años de la serie temporal. Las trabajadoras agrícolas tuvieron mayores probabilidades de desarrollar cáncer de mama durante todo el período en comparación con las trabajadoras de otros sectores (OR 14,85; IC 95% 12,70 - 17,36 en 2018). Se concluye que la incidencia de cáncer de mama en trabajadoras agrícolas es significativa en Paraná y que ser trabajadora de este sector, aumenta significativamente las probabilidades de desarrollar cáncer de mama. A partir de estos datos, se espera ayudar en la formulación de políticas, orientando prioridades y acciones para reducir la incidencia y mortalidad de este agravio, contribuyendo a la consecución del objetivo 3 'salud y bienestar' de los Objetivos de Desarrollo Sostenible (ODS).

Tuberculosis preventive treatment in children and adolescents: an observational study of secondary data

Abstract Objective To analyze the effectiveness, safety, outcomes, and associated factors of tuberculosis preventive treatment (TPT) in children and adolescents in Paraná, southern Brazil. Method This was an observational cohort study with a retrospective collection of secondary data from the TPT information systems of the state of Paraná from 2009 to 2016, and tuberculosis in Brazil from 2009 to 2018. Results In total, 1,397 people were included. In 95.4% of the individuals, the indication for TPT was a history of patient-index contact with pulmonary tuberculosis. Isoniazid was used in 99.9% of the cases with TPT, and 87.7% completed the treatment. The TPT protection was 98.7%. Among the 18 people who had TB, 14 (77.8%) became ill after the second year of treatment, and four (22.2%) in the first two years (p < 0.001). Adverse events were reported in 3.3% of cases, most of them were gastrointestinal and medication was discontinued in only 2 (0.1%) patients. No risk factors associated with the illness were observed. Conclusions The authors observed a low rate of illness in pragmatics routine conditions in TPT for children and adolescents, especially within the first two years after the end of treatment, with good tolerability and a good percentage of adherence to the treatment. TPT should be encouraged to achieve the goals of the End TB Strategy of the World Health Organization as an essential strategy to reduce the incidence rate of the disease, but studies with new schemes must continue to be carried out in real-life scenarios.

Adaptação transcultural e validação do instrumento Parental Health Literacy Activities Test (PHLAT) / Transcultural adaptation and validation of the instrument Parental Health Literacy Activities Test (PHLAT)

RESUMO O objetivo do estudo foi realizar a tradução, a adaptação cultural e a validação psicométrica do instrumento Parental Health Literacy Activities Test (PHLAT), que avalia o letramento em saúde para cuidadores/familiares que buscam atendimento às suas crianças menores de 1 ano na unidade de atenção primária. Estudo metodológico, quantitativo, de validação e adaptação transcultural de instrumento, seguindo as etapas de tradução, retrotradução, análise por comitê de juízes, aplicação de testes estatísticos para avaliação das propriedades psicométricas, obtendo-se sua versão para o português do Brasil. O pré-teste foi realizado com 31 familiares, e o teste/reteste, com 93, em unidades de atenção primária do município do Oeste do Paraná, em 2018 e 2019. Análise estatística inferencial foi aplicada para verificar a validade e a confiabilidade do instrumento. Na validade de conteúdo com comitê de juízes, obteve-se taxa de concordância de 100%. Os dados na fase de pré-teste apresentaram coeficiente Alfa de Cronbach de 0,73; e na etapa do teste/reteste, obteve-se 0,69. A avaliação da confiabilidade pelo coeficiente de correlação intraclasse foi de 0,865, considerada substancial. O instrumento foi tido como adequado quanto a sua adaptação cultural e validado para o português do Brasil, confiável para a aplicação entre cuidadores/familiares.

ABSTRACT The purpose of the study was to perform the translation, cultural adaptation and psychometric validation of the instrument Parental Health Literacy Activities Test (PHLAT), which assesses health literacy for caregivers/family members seeking care for their children under one year old in the primary care unit. Methodological, quantitative, validation and cross-cultural instrument adaptation study, following the steps of translation, back-translation, judges committee analysis, application of statistical tests to evaluate psychometric properties, obtaining its version for Brazilian Portuguese. The pre-test was performed with 31 family members and test/retest with 93, in primary care units in the municipality of Western Paraná, in 2018 and 2019. Inferential statistical analysis was applied to verify the validity and reliability of the instrument. On the content validity of the judges committee, a 100% agreement rate was obtained. The data in the pretest phase presented Cronbach's alpha coefficient of 0.73, and the test/retest of 0.69. The reliability assessment by the intraclass correlation coefficient was 0.865, considered substantial. The instrument was considered adequate for its cultural adaptation and validated for Brazilian Portuguese, reliable for application between caregivers/family members.

Development and validation of a UPLC-ESI-MS/MS method for the determination of N-butylscopolamine in human plasma: application to a bioequivalence study.

A sensitive and fast ultra performance liquid chromatography-electrospray ionization-tandem mass spectrometry (UPLC-ESI-MS/MS) method for measurements of N-butylscopolamine in plasma was developed and validated. A single protein precipitation was proposed for the clean up of the plasma and N-methylhomatropine was added as internal standard (IS). The analyses were carried out using a C(18) column and mobile phase of acetonitrile: 5 mM ammonium acetate + 0.1% formic acid (90:10, v/v). The triple quadrupole mass spectrometer equipped with an electrospray source in positive mode, was set up in selective reaction monitoring, to detect precursor → product ion 360.0 → 194.0 m/z and 290.3 → 138.0 m/z transitions, for N-butylscopolamine and IS, respectively. The method was linear in 0.03 (lower limit of quantitation; LLOQ) - 10.00 ng/ml range for N-butylscopolamine. Satisfactory selectivity, linearity, precision, accuracy, and robustness were obtained for the UPLC-ESI-MS/MS method. The proposed method was successfully applied to a pharmacokinetic study of healthy human volunteers; the results showed that the two scopolamine butylbromide formulations tested are not bioequivalent in rate and extent of absorption.

Bioavailability of two oral formulas of secnidazole in healthy volunteers / Biodisponibilidade de duas fórmulas de secnidazol oral em voluntários saudáveis

Secnidazole is an antimicrobial agent used primarily in the treatment of amoebiasis. For this bioequivalence study of secnidazole, twenty-eight healthy female volunteers were enrolled in a randomized crossover study. Each volunteer was given a single oral dose of secnidazole test preparation and then the reference preparation, or vice versa, with a wash out interval of two weeks. The plasma concentrations of secnidazole were determined by HPLC, and the samples were extracted with tert-butyl-methyl-ether: dicloromethane (60:40, v/v). Secnidazole and its parent compound metronidazole were separated on a C18 column with water:acetonitrile (85:15, v/v) as the mobile phase, and monitored at 310 nm. The ratio of mean Cmax, AUC0-t and AUC0-∞ values for the test and reference products were within the predetermined range established by ANVISA, demonstrating that the two formulations are bioequivalent in rate and extent of absorption.

Secnidazol é um agente antimicrobiano utilizado principalmente no tratamento da amebíase. Para este estudo de bioequivalência de secnidazol em voluntários saudáveis, foram incluídos vinte e oito voluntárias mulheres no estudo randomizado cruzado. Cada voluntária recebeu uma única dose oral de secnidazol do produto teste e referência para comparação, com um intervalo de wash-out de duas semanas. As concentrações plasmáticas de secnidazol foram determinados por CLAE, as amostras foram extraídas com terc-butil-metil-éter: dicloromethano (60:40, v/v). O secnidazol e seu padrão interno metronidazol foram separados em uma coluna (C18 ) com fase móvel água ultra-pura:acetonitrila (85:15, v/v) e monitorado em 310 nm. As razões entre as médias geométricas de Cmáx, ASC0-t e ASC0-∞, encontraram-se dentro do estabelecido pela ANVISA, demonstrando que as formulações são bioequivalentes quanto à taxa e extensão de absorção.