RESUMEN
BACKGROUND: Genetic testing is recommended for accurate diagnosis of Bartter syndrome (BS) and serves as a basis for implementing specific target therapies. However, populations other than Europeans and North Americans are underrepresented in most databases and there are uncertainties in the genotype-phenotype correlation. We studied Brazilian BS patients, an admixed population with diverse ancestry. METHODS: We evaluated the clinical and mutational profile of this cohort and performed a systematic review of BS mutations from worldwide cohorts. RESULTS: Twenty-two patients were included; Gitelman syndrome was diagnosed in 2 siblings with antenatal BS and congenital chloride diarrhea in 1 girl. BS was confirmed in 19 patients: BS type 1 in 1 boy (antenatal BS); BS type 4a in 1 girl and BS type 4b in 1 girl, both of them with antenatal BS and neurosensorial deafness; BS type 3 (CLCNKB mutations): 16 cases. The deletion of the entire CLCNKB (1-20 del) was the most frequent variant. Patients carrying the 1-20 del presented earlier manifestations than those with other CLCNKB-mutations and the presence of homozygous 1-20 del was correlated with progressive chronic kidney disease. The prevalence of the 1-20 del in this BS Brazilian cohort was similar to that of Chinese cohorts and individuals of African and Middle Eastern descent from other cohorts. CONCLUSION: This study expands the genetic spectrum of BS patients with different ethnics, reveals some genotype/phenotype correlations, compares the findings with other cohorts, and provides a systematic review of the literature on the distribution of BS-related variants worldwide.
Asunto(s)
Síndrome de Bartter , Embarazo , Femenino , Humanos , Síndrome de Bartter/genética , Brasil , Fenotipo , Mutación , Miembro 1 de la Familia de Transportadores de Soluto 12/genética , Canales de Cloruro/genéticaRESUMEN
OBJECTIVE: the care of adolescents with or without a chronic disease must complete, standardized and focused on individual demands and the transition process to adult care and adherence to treatment. This study aimed to characterize the care provided by nurses from the state of São Paulo who work with adolescents. METHOD: this is a cross-sectional and descriptive study on the care provided to adolescents by nurses in São Paulo, based on the answers to a self-administered questionnaire, available in the REDCap tool between August 2018 and October 2019. RESULTS: participants answered 1632 questionnaires. Only 38% of nurses work with adolescents, 11.2% exclusively. Professionals were divided according to the median length of professional experience in groups A and B (≤5 years and >5 years). Drug addiction (p=0.01) and working with a multidisciplinary team (p=0.04) were significantly more reported in group B. Routine follow-up (p=0.02) and questioning about sexual or physical violence (p=0.03) were significantly more performed by professionals from group A. CONCLUSION: this study identified the need for a care protocol that can be replicated on a large scale and that includes the treatment and the particularities of adolescents to improve adherence and the transition into adult care. KEYPOINTS: (1) Nursing consultation is essential for adolescents. (2) Care protocols must address the particularities of adolescents. (3) The transition to adult care is important and deserves attention. (4) Remuneration can impact the performance of nurses' activities, updates and training.
Asunto(s)
Enfermeras y Enfermeros , Atención de Enfermería , Adulto , Humanos , Adolescente , Brasil , Estudios Transversales , Encuestas y Cuestionarios , Derivación y ConsultaRESUMEN
Abstract Objective: the care of adolescents with or without a chronic disease must complete, standardized and focused on individual demands and the transition process to adult care and adherence to treatment. This study aimed to characterize the care provided by nurses from the state of São Paulo who work with adolescents. Method: this is a cross-sectional and descriptive study on the care provided to adolescents by nurses in São Paulo, based on the answers to a self-administered questionnaire, available in the REDCap tool between August 2018 and October 2019. Results: participants answered 1632 questionnaires. Only 38% of nurses work with adolescents, 11.2% exclusively. Professionals were divided according to the median length of professional experience in groups A and B (≤5 years and >5 years). Drug addiction (p=0.01) and working with a multidisciplinary team (p=0.04) were significantly more reported in group B. Routine follow-up (p=0.02) and questioning about sexual or physical violence (p=0.03) were significantly more performed by professionals from group A. Conclusion: this study identified the need for a care protocol that can be replicated on a large scale and that includes the treatment and the particularities of adolescents to improve adherence and the transition into adult care.
Resumo Objetivo: o cuidado de adolescentes com ou sem doença crônica deve ser completo, padronizado e focado nas demandas individuais e no processo de transição para a assistência ao adulto e adesão ao tratamento. Este estudo teve como objetivo caracterizar a assistência prestada por enfermeiros do estado de São Paulo que atuam com adolescentes. Método: trata-se de um estudo transversal e descritivo sobre a assistência prestada a adolescentes por enfermeiros de São Paulo, a partir das respostas a um questionário autoaplicável, disponível no instrumento REDCap entre agosto de 2018 e outubro de 2019. Resultados: os participantes responderam a 1632 questionários. Apenas 38% dos enfermeiros trabalham com adolescentes, e 11,2% deles de forma exclusiva. Os profissionais foram divididos de acordo com a mediana de tempo de experiência profissional nos Grupos A e B (≤ 5 anos e > 5 anos). A dependência de drogas (p=0,01) e o trabalho com uma equipe multidisciplinar (p=0,04) foram significativamente mais relatados no Grupo B. O acompanhamento rotineiro (p=0,02) e o questionamento sobre violência sexual ou física (p=0,03) foram significativamente mais realizados pelos profissionais do Grupo A. Conclusão: este estudo identificou a necessidade de um protocolo de assistência que possa ser replicado em larga escala e que inclua o tratamento e as particularidades dos adolescentes para melhorar a adesão e a transição para o cuidado do adulto.
Resumen Objetivo: el cuidado de los adolescentes con o sin enfermedad crónica debe ser completo, estandarizado y centrado en las demandas individuales y en el proceso de transición a la atención para adultos y la adherencia al tratamiento. Este estudio tuvo como objetivo caracterizar los cuidados prestados por el personal de enfermería del estado de São Paulo que trabaja con adolescentes. Método: se trata de un estudio transversal y descriptivo sobre los cuidados prestados a los adolescentes por el personal de enfermería de São Paulo, a partir de las respuestas a un cuestionario autoadministrado, disponible en la herramienta REDCap entre agosto de 2018 y octubre de 2019. Resultados: los participantes respondieron a 1.632 cuestionarios. Solo el 38% del personal de enfermería trabaja con adolescentes, el 11,2% de forma exclusiva. Los profesionales se dividieron según la duración media de la experiencia profesional en los grupos A y B (≤5 años y >5 años). La drogadicción (p=0,01) y el trabajo con un equipo multidisciplinar (p=0,04) fueron significativamente más reportados en el grupo B. El seguimiento rutinario (p=0,02) y las preguntas sobre violencia sexual o física (p=0,03) fueron significativamente más realizadas por los profesionales del grupo A. Conclusión: este estudio identificó la necesidad de un protocolo de atención que pueda ser replicado a gran escala y que incluya el tratamiento y las particularidades de los adolescentes para mejorar la adherencia y la transición a la atención de adultos.
Asunto(s)
Humanos , Adolescente , Adulto , Planificación de Atención al Paciente , Derivación y Consulta , Brasil , Estudios Transversales , Encuestas y Cuestionarios , Enfermeras y Enfermeros , Atención de EnfermeríaRESUMEN
Resumo Objetivo: avaliar problemas de saúde mental em enfermeiros pediátricos durante a pandemia causada pelo coronavírus 2019. Método: estudo transversal realizado com enfermeiros pediátricos do Instituto da Criança e do Adolescente, por meio de uma pesquisa online de autoavaliação sobre prática clínica e impacto na saúde mental, durante a pandemia de COVID-19. Foram avaliadas escalas de autoavaliação validadas para ansiedade, depressão e burnout. Resultados: 107/298(36%) enfermeiros responderam, dos quais 90% eram do sexo feminino, a mediana de idade atual era 41(23-64) anos, 68% trabalhavam com adolescentes, 66% trabalhavam na linha de frente. Burnout, ansiedade e depressão moderada/grave ocorreram em 65%, 72% e 74% dos enfermeiros, respectivamente. Falta de protocolo de tratamento padronizado nas enfermarias (27% vs. 10%, p=0,049), depressão moderada/grave (74% vs. 16%, p=0,002) e burnout (82% vs. 58%, p=0,01) foram significativamente maiores em enfermeiros pediátricos com ansiedade, em comparação com enfermeiros sem essa condição. Os enfermeiros pediátricos que trabalhavam com adolescentes apresentaram maior frequência de burnout, quando comparados aos que não trabalhavam com esse grupo (77% vs. 32%, p=0,0001). A análise multivariada revelou que o cumprimento adequado da quarentena aumentou a presença de ansiedade em 4,6 vezes [OR 4.6(IC 1,1-20,2), p=0,04]. Conclusão: a maioria dos enfermeiros pediátricos atuava na linha de frente da COVID-19, em condições precárias, trabalhando com equipe reduzida e enfrentando perdas expressivas de renda. A ansiedade atual foi um tema relevante e o burnout também foi uma condição mental importante para esses profissionais, reforçando a cultura do bom trabalho em equipe, das práticas de colaboração e do cuidado psicológico/psiquiátrico.
Abstract Objective: to assess mental health issues in pediatric nurses during coronavirus pandemic in 2019. Method: cross-sectional study was conducted with pediatric nurses at the Instituto da Criança e do Adolescente based on online self-rated survey about clinical practice and mental health impact during COVID-19 pandemic. Validated self-reported scales for anxiety, depression and burnout were used for assessing these professionals. Results: 107/298 (36%) nurses answered, 90% were female, median age was 41(23-64) years, 68% worked with adolescents, 66% in frontline. Burnout, anxiety and moderate/severe depression occurred in 65%, 72% and 74%, respectively. Lack of standardized treatment protocol for nurses (27%vs.10%, p=0.049), moderate/severe depression (74% vs. 16%, p=0.002) and burnout (82% vs. 58%, p=0.01) were significantly higher in pediatric nurses with anxiety compared to those without. Pediatric nurses that worked with adolescents compared to those that did not showed higher frequency of burnout in the former group (77% vs. 32%, p=0.0001). Multivariable analysis revealed that adequate quarantine adherence increased the presence of anxiety in 4.6 times [OR4.6(CI 1.1-20.2), p=0.04]. Conclusion: most pediatric nurses who had worked in the frontline of COVID-19 were under precarious conditions, working with reduced team, and with an expressive changes in their monthly income. Current anxiety was a relevant issue, burnout was also an important mental condition for these professionals, reinforcing culture of good teamwork, collaboration practices and psychological/psychiatric approach.
Resumen Objetivo: evaluar los problemas de salud mental en enfermeros pediátricos durante la pandemia del coronavirus 2019. Método: estudio transversal realizado con enfermeros pediátricos del Instituto da Criança e do Adolescente mediante una encuesta de autoevaluación en línea sobre la práctica clínica y el impacto en la salud mental durante la pandemia de COVID-19. Se evaluaron escalas de autoevaluación validadas para ansiedad, depresión y burnout. Resultados: respondieron 107/298 (36%) de los enfermeros, de los cuales 90% eran del sexo femenino, la mediana de edad actual fue de 41 (23-64) años, 68% trabajaban con adolescentes, 66% trabajaban en primera línea. Burnout, ansiedad y depresión moderada/grave ocurrieron en 65%, 72% y 74% de los enfermeros, respectivamente. Falta de protocolo de tratamiento estandarizado en las enfermerías (27% vs. 10%, p=0,049), depresión moderada/grave (74% vs. 16%, p=0,002) y burnout (82% vs. 58%, p=0,01) fueron significativamente mayores en enfermeros pediátricos con ansiedad en comparación con enfermeros sin esta condición. Los enfermeros pediátricos que trabajaban con adolescentes presentaron mayor frecuencia de burnout en comparación con los que no trabajaban con adolescentes (77% vs. 32%, p=0,0001). El análisis multivariado reveló que el adecuado cumplimiento de la cuarentena aumentó 4,6 veces la presencia de ansiedad [OR 4.6(IC 1,1-20,2), p=0,04]. Conclusión: La mayoría de los enfermeros pediátricos trabajaban en la primera línea de la COVID-19, en condiciones precarias, trabajando con un equipo reducido y enfrentando importantes pérdidas de ingresos. La ansiedad actual fue un tema relevante y el burnout también fue una condición mental importante para estos profesionales, reforzando la cultura del buen trabajo en equipo, las prácticas colaborativas y la atención psicológica/psiquiátrica.
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Ansiedad , Agotamiento Profesional , Estudios Transversales , Encuestas y Cuestionarios , Perfil de Impacto de Enfermedad , Enfermeras Pediátricas , COVID-19RESUMEN
OBJECTIVES: This study aimed to investigate subclinical left ventricle (LV) systolic dysfunction in juvenile dermatomyositis (JDM) using two-dimensional speckle-tracking echocardiography (2DST). Possible associations between LV deformation impairment and disease activity/cumulative damage were also evaluated. METHODS: Thirty-five consecutive JDM patients without cardiac symptoms and 35 healthy volunteers were enrolled. Clinical data were collected from medical records, and echocardiograms were performed by a pediatric cardiologist, unaware of patients' conditions. RESULTS: Patients and controls had similar age (12.6 ± 0.7 vs.12.5 ± 0.6; p = 0.97) and gender (11F:24M vs.11F:24M; p = 1.0). Median of JDM duration was 4.6 (0.04-17.6) years, and only 6/35 (17%) had active disease (disease activity score (DAS > 3)). Conventional echocardiogram revealed preserved LV ejection fraction (EF) (≥ 55%) in all individuals. In JDM, 2DST identified reduction of LV longitudinal [-22(-17.2 to -27.9) % vs. -23(-20.8 to -27.4) %; p = 0.028)] and circumferential -23.9 ± 2.8% vs. -26.7 ± 2.9%; p = 0.0002) strain. Lower longitudinal strain was associated with DAS >3 -19.9(-17.2 to -26.5)% vs. -22.1-18.9 to -27.9)%; p = 0.046], MDI extent > 0 [-19(-17.2 to -22.5)% vs. -22.1-19.2 to -27.9)%; p = 0.0008], MDI severity > 0 [-19(-17.2 to -22.1)% vs. -22.3(-20.3 to -27.9)%; p = 0.0001] and calcinosis[-20.6(-17.2 to -23)% vs. -22.3(-20.3 to -27.9)%; p = 0.03]. Lower circumferential strain was associated with MDI extent > 0 (-22.1 ± 3.87% vs. -24.4 ± 2.3%; p = 0.039), MDI severity > 0 (-21.7 ± 3% vs. 24.7 ± 2.3%; p = 0.004) and calcinosis (-22.5 ± 3.3% vs. -24.8 ± 2.1%; p = 0.02). There was a negative correlation between longitudinal strain and cumulative dose of prednisone (r = -0.44; p = 0.009) and methotrexate (r = -0.33; p = 0.0008). CONCLUSIONS: LV 2DST detected early systolic myocardial compromise in asymptomatic pediatric JDM patients, with preserved EF. Longitudinal strain impairment was associated with disease activity and cumulative damage, whereas circumferential strain impairment was associated exclusively with cumulative damage. KEY POINTS: ⢠Serious cardiac involvement is rare but has been associated with death in juvenile dermatomyositis. ⢠Two-dimensional speckle tracking stands out for the identification of subclinical myocardial compromise in juvenile dermatomyositis. ⢠Longitudinal strain impairment is associated with disease activity and cumulative damage, whereas circumferential strain impairment is associated exclusively with cumulative damage.
Asunto(s)
Dermatomiositis , Disfunción Ventricular Izquierda , Niño , Dermatomiositis/complicaciones , Dermatomiositis/diagnóstico por imagen , Ecocardiografía , Humanos , Volumen Sistólico , Disfunción Ventricular Izquierda/diagnóstico por imagen , Función Ventricular IzquierdaRESUMEN
Abstract Care for patients with chronic and rare diseases is complex, especially considering the lack of knowledge about the disease, which makes early and precise diagnosis difficult, as well as the need for specific tests, sometimes of high complexity and cost. Added to these factors are difficulties in obtaining adequate treatment when available, in raising patient and family awareness about the disease and treatment compliance. Nephropathic cystinosis is among these diseases. After more than 20 years as a care center for these patients, the authors propose a follow-up protocol, which has been used with improvement in the quality of care and consists of a multidisciplinary approach, including care provided by a physician, nurse, psychologist, nutritionist and social worker. In this paper, each field objectively exposes how to address points that involve the stages of diagnosis and its communication with the patient and their relatives or guardians, covering the particularities of the disease and the treatment, the impact on the lives of patients and families, the approach to psychological and social issues and guidelines on medications and diets. This protocol could be adapted to the follow-up of patients with other rare diseases, including those with renal involvement. This proposal is expected to reach the largest number of professionals involved in the follow-up of these patients, strengthening the bases for the creation of a national protocol, observing the particularities of each case.
Resumo A assistência a pacientes com doenças crônicas e raras é complexa, principalmente pela falta de disseminação de conhecimento sobre a doença, o que dificulta o diagnóstico preciso e precoce, além da necessidade da realização de exames específicos, por vezes de alta complexidade e custo. Somam-se a esses fatores dificuldades na obtenção de tratamento adequado quando disponível, na conscientização do paciente e da família sobre a doença e na aderência ao tratamento. A cistinose nefropática está entre essas doenças. Após mais de 20 anos como centro de atendimento a esses pacientes, os autores propõem um protocolo de seguimento, o qual vem sendo empregado com melhora na qualidade da assistência e consiste de uma abordagem multidisciplinar, incluindo, principalmente, atendimento prestado por médico, enfermeiro, psicólogo, nutricionista e assistente social. Neste artigo, cada área expõe de maneira objetiva como abordar pontos que envolvem as etapas do diagnóstico e sua comunicação ao paciente e a seus familiares ou responsáveis, abrangendo as particularidades da doença e do tratamento, o impacto na vida do paciente e de sua família, a abordagem das questões psicológicas e sociais e orientações quanto a medicamentos e dietas. Considera-se que este protocolo poderia ser adaptado ao seguimento de pacientes portadores de outras doenças raras, incluindo aquelas com envolvimento renal. Com essa proposta, espera-se alcançar o maior número de profissionais envolvidos no seguimento desses pacientes, fortalecendo as bases para a criação de um protocolo nacional, observando-se as particularidades de cada caso.
Asunto(s)
Humanos , Masculino , Femenino , Recién Nacido , Lactante , Preescolar , Niño , Adolescente , Adulto , Adulto Joven , Cistinosis/diagnóstico , Cistinosis/terapia , Enfermedades Raras/diagnóstico , Síndrome de Fanconi/diagnóstico , Síndrome de Fanconi/tratamiento farmacológico , Grupo de Atención al Paciente , Embarazo , Protocolos Clínicos , Diálisis Renal , Trasplante de Riñón , Resultado del Tratamiento , Cistinosis/complicaciones , Cistinosis/psicología , Enfermedades Raras/complicaciones , Enfermedades Raras/psicología , Enfermedades Raras/tratamiento farmacológico , Diálisis , Síndrome de Fanconi/complicaciones , Síndrome de Fanconi/psicología , Fallo Renal Crónico/etiologíaRESUMEN
Care for patients with chronic and rare diseases is complex, especially considering the lack of knowledge about the disease, which makes early and precise diagnosis difficult, as well as the need for specific tests, sometimes of high complexity and cost. Added to these factors are difficulties in obtaining adequate treatment when available, in raising patient and family awareness about the disease and treatment compliance. Nephropathic cystinosis is among these diseases. After more than 20 years as a care center for these patients, the authors propose a follow-up protocol, which has been used with improvement in the quality of care and consists of a multidisciplinary approach, including care provided by a physician, nurse, psychologist, nutritionist and social worker. In this paper, each field objectively exposes how to address points that involve the stages of diagnosis and its communication with the patient and their relatives or guardians, covering the particularities of the disease and the treatment, the impact on the lives of patients and families, the approach to psychological and social issues and guidelines on medications and diets. This protocol could be adapted to the follow-up of patients with other rare diseases, including those with renal involvement. This proposal is expected to reach the largest number of professionals involved in the follow-up of these patients, strengthening the bases for the creation of a national protocol, observing the particularities of each case.
Asunto(s)
Cistinosis/diagnóstico , Cistinosis/tratamiento farmacológico , Síndrome de Fanconi/diagnóstico , Síndrome de Fanconi/tratamiento farmacológico , Enfermedades Raras/diagnóstico , Enfermedades Raras/tratamiento farmacológico , Adolescente , Adulto , Niño , Preescolar , Protocolos Clínicos , Cistinosis/complicaciones , Cistinosis/psicología , Diálisis , Síndrome de Fanconi/complicaciones , Síndrome de Fanconi/psicología , Femenino , Humanos , Lactante , Recién Nacido , Fallo Renal Crónico/etiología , Trasplante de Riñón , Masculino , Grupo de Atención al Paciente , Embarazo , Enfermedades Raras/complicaciones , Enfermedades Raras/psicología , Diálisis Renal , Resultado del Tratamiento , Adulto JovenRESUMEN
Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015. Immediately after the informed consent was signed, participants underwent blood collection followed by vaccination. On study days 1, 2 and 3 post-vaccination participants were contacted by the staff to evaluate the occurrence of solicited (local and systemic) and non-solicited adverse reactions. On study day 21 (+7) subjects returned to the clinical site for final safety assessments and blood collection to evaluate post-vaccination immunogenicity. The immunogenicity analyses were performed by means of hemagglutination inhibition (HI) assay. The immunogenicity endpoints were: seroprotection (SPR) and seroconversion (SCR) rates and the geometric mean HI antibody titer ratio (GMTR). The 2013 study was conducted at the Centro de Referência para Imunobiológicos Especiais (CRIE) and at the Centro de Pesquisa Clínica do Instituto da Criança, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo while the 2014 and 2015 studies were conducted at CRIE. The vaccine composition followed the WHO recommendation for the Southern hemisphere seasonal influenza vaccine. Forty-seven healthy adults and 13 elderly participated in the 2013 study, 60 healthy adults and 60 elderly in the 2014 study, and 62 healthy adults and 57 elderly in the 2015 study. In the 2013, 2014 and 2015 studies, pain was the most frequent local adverse reaction and headache the most frequent systemic adverse reaction. All observed adverse reactions were classified as mild or moderate and none as severe. SPR >70% and SPR >60% were observed in adults and elderly, respectively, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. SCR >40% was observed in adults, for the three vaccine viruses, only in the 2014 study and SCR >30% was observed in the elderly, for the three vaccine viruses, only in the 2013 and 2014 studies. GMTR >2.5 among adults, for the three vaccine viruses was only observed in the 2013 study and GMTR >2.0 was observed among elderly, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. The 2013, 2014 and 2015 seasonal influenza vaccines produced by Instituto Butantan were safe and immunogenic according to the immunogenicity criteria defined by the European Medicines Agency (EMA).
Asunto(s)
Anticuerpos Antivirales/sangre , Subtipo H1N1 del Virus de la Influenza A/inmunología , Vacunas contra la Influenza/inmunología , Gripe Humana/inmunología , Adolescente , Adulto , Pruebas de Inhibición de Hemaglutinación , Humanos , Vacunas contra la Influenza/efectos adversos , Gripe Humana/prevención & control , Persona de Mediana Edad , Estudios Prospectivos , Estaciones del Año , Adulto JovenRESUMEN
Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015. Immediately after the informed consent was signed, participants underwent blood collection followed by vaccination. On study days 1, 2 and 3 post-vaccination participants were contacted by the staff to evaluate the occurrence of solicited (local and systemic) and non-solicited adverse reactions. On study day 21 (+7) subjects returned to the clinical site for final safety assessments and blood collection to evaluate post-vaccination immunogenicity. The immunogenicity analyses were performed by means of hemagglutination inhibition (HI) assay. The immunogenicity endpoints were: seroprotection (SPR) and seroconversion (SCR) rates and the geometric mean HI antibody titer ratio (GMTR). The 2013 study was conducted at the Centro de Referência para Imunobiológicos Especiais (CRIE) and at the Centro de Pesquisa Clínica do Instituto da Criança, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo while the 2014 and 2015 studies were conducted at CRIE. The vaccine composition followed the WHO recommendation for the Southern hemisphere seasonal influenza vaccine. Forty-seven healthy adults and 13 elderly participated in the 2013 study, 60 healthy adults and 60 elderly in the 2014 study, and 62 healthy adults and 57 elderly in the 2015 study. In the 2013, 2014 and 2015 studies, pain was the most frequent local adverse reaction and headache the most frequent systemic adverse reaction. All observed adverse reactions were classified as mild or moderate and none as severe. SPR >70% and SPR >60% were observed in adults and elderly, respectively, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. SCR >40% was observed in adults, for the three vaccine viruses, only in the 2014 study and SCR >30% was observed in the elderly, for the three vaccine viruses, only in the 2013 and 2014 studies. GMTR >2.5 among adults, for the three vaccine viruses was only observed in the 2013 study and GMTR >2.0 was observed among elderly, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. The 2013, 2014 and 2015 seasonal influenza vaccines produced by Instituto Butantan were safe and immunogenic according to the immunogenicity criteria defined by the European Medicines Agency (EMA).
RESUMEN
Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015. Immediately after the informed consent was signed, participants underwent blood collection followed by vaccination. On study days 1, 2 and 3 post-vaccination participants were contacted by the staff to evaluate the occurrence of solicited (local and systemic) and non-solicited adverse reactions. On study day 21 (+7) subjects returned to the clinical site for final safety assessments and blood collection to evaluate post-vaccination immunogenicity. The immunogenicity analyses were performed by means of hemagglutination inhibition (HI) assay. The immunogenicity endpoints were: seroprotection (SPR) and seroconversion (SCR) rates and the geometric mean HI antibody titer ratio (GMTR). The 2013 study was conducted at the Centro de Referência para Imunobiológicos Especiais (CRIE) and at the Centro de Pesquisa Clínica do Instituto da Criança, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo while the 2014 and 2015 studies were conducted at CRIE. The vaccine composition followed the WHO recommendation for the Southern hemisphere seasonal influenza vaccine. Forty-seven healthy adults and 13 elderly participated in the 2013 study, 60 healthy adults and 60 elderly in the 2014 study, and 62 healthy adults and 57 elderly in the 2015 study. In the 2013, 2014 and 2015 studies, pain was the most frequent local adverse reaction and headache the most frequent systemic adverse reaction. All observed adverse reactions were classified as mild or moderate and none as severe. SPR >70% and SPR >60% were observed in adults and elderly, respectively, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. SCR >40% was observed in adults, for the three vaccine viruses, only in the 2014 study and SCR >30% was observed in the elderly, for the three vaccine viruses, only in the 2013 and 2014 studies. GMTR >2.5 among adults, for the three vaccine viruses was only observed in the 2013 study and GMTR >2.0 was observed among elderly, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. The 2013, 2014 and 2015 seasonal influenza vaccines produced by Instituto Butantan were safe and immunogenic according to the immunogenicity criteria defined by the European Medicines Agency (EMA).
RESUMEN
OBJETIVO: Caracterizar o perfil de capacitação profissional do enfermeiro de um Complexo Hospitalar de Ensino, a partir da percepção das Diretoras de Enfermagem. MÉTODOS: Nesta pesquisa qualitativa utilizou-se o método do Estudo de Caso e adotou-se a técnica da entrevista semi-estruturada realizada com 12 colaboradores. RESULTADOS: Os dados coletados, analisados utilizando-se a Análise de Conteúdo, possibilitaram o resgate das Categorias Política Institucional, Política de Gerenciamento de Recursos Humanos e Elementos Intervenientes no Processo de Capacitação Profissional do Enfermeiro. CONCLUSÕES: Não há uma política institucional formalizada de capacitação do enfermeiro; a questão salarial é elemento dificultador para a capacitação; a contrapartida das instituições de ensino aparece como recurso para capacitação; dois Institutos não possuem Serviço de Educação Continuada e o perfil demandado é de um profissional com postura ética, conhecimento técnico-científico, capacidade de gerenciar sua equipe, assíduo, pontual e comprometido com a Instituição.
OBJECTIVE: To characterize the components of a capacitating program for nurses working in major teaching medical centers. METHODS: A case study approach was used to conduct this study. Data were collected through semi-structured interviews with 12 directors of nursing. Data were analyzed through content analysis. RESULTS: The findings consisted of the following themes: Institutional politics, human resources policies, and specific intervening elements of the professional capacitating program for nurses. CONCLUSIONS: There were no formal institutional policies for professional capacitation of nurses. The nurses' salary level was an element that made the implementation of a professional capacitating program for nurses difficult. Two medical centers did not have a department of continuing education. In addition, there was a need for capacitating nurses to: behave ethically; develop scientific, technical, and management knowledge; and, be assiduous, punctual, and committed to the institution.
OBJETIVO: Caracterizar el perfil de capacitación profesional del enfermero de un Complejo Hospitalario de Enseñanza, a partir de la percepción de las Directoras de Enfermería. MÉTODOS: en esta investigación cualitativa se utilizó el método del Estudio de Caso adoptándose la técnica de la entrevista semi-estructurada realizada con 12 colaboradores. RESULTADOS: Los datos recolectados, analizados por medio del Análisis de Contenido, posibilitaron el rescate de las Categorías Política Institucional, Política de Gerenciamiento de Recursos Humanos y Elementos Intervinientes en el Proceso de Capacitación Profesional del Enfermero. CONCLUSIONES: No hay una política institucional formalizada de capacitación del enfermero; la cuestión salarial es el elemento que dificulta la capacitación; la contrapartida de las instituciones de enseñanza aparece como recurso para capacitación; dos Institutos no poseen Servicio de Educación Continua y el perfil demandado es el de un profesional con postura ética, conocimiento técnico-científico, capacidad para gerenciar su equipo, asiduo, puntual y comprometido con la Institución.
RESUMEN
No âmbito hospitalar o número de enfermeiros é significativo, atuando desde o âmbito assistencial até cargos de chefia e participação em assessorias. Todavia, para essa atuação, o conhecimento não é definitivo, sendo necessário que o profissional desenvolva aprendizagem contínua e atualizada. A presente pesquisa qualitativa teve como objetivo geral caracterizar um perfil de capacitação profissional do enfermeiro de um Complexo Hospitalar de ensino a partir da percepção das Diretoras de Divisão de Enfermagem dos Institutos que compõem o pólo central do Complexo Hospitalar do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, e como objetivos específicos: identificar a percepção das colaboradoras acerca do perfil de capacitação dos enfermeiros; conhecer as propostas que orientam essa capacitação; e analisar os elementos institucionais necessários para a efetivação desse processo. Optou-se pelo método do Estudo de Caso, cuja flexibilidade permite confirmar, modificar, ou ampliar o conhecimento sobre o objeto que estuda, contribuindo assim para a construção teórica do respectivo domínio do conhecimento. Foram colaboradoras do estudo as seis Diretoras de Divisão de Enfermagem do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo e suas substitutas, totalizando doze colaboradoras. A coleta de dados foi realizada por meio de entrevistas semiestruturadas, após aprovação do estudo pelo Comitê de Ética em Pesquisa daEEUSP e da Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, e assinatura do Termo de Consentimento Livre e Esclarecido pelas colaboradoras. Para análise dos dados foi adotada a técnica da Análise de Conteúdo de Bardin, que possibilitou o resgate das Categorias Política Institucional, Política de Gerenciamento de ) Recursos Humanos e Elementos Intervenientes do Processo de Capacitação Profissional do Enfermeiro. Os resultados mostraram que não há uma política institucional formalizada para a capacitação do enfermeiro em todos os Institutos; que a contratação de enfermeiros recém-formados e a questão salarial são elementos dificultadores para a capacitação; a contrapartida das instituições de ensino aparece como um recurso para atender às necessidades de capacitação do enfermeiro; dois Institutos não possuem Serviço de Educação Continuada; o perfil do profissional demandado, na concepção semelhante das colaboradoras, é de um profissional com postura ética, conhecimento técnico-científico, capacidade de gerenciar sua equipe, assíduo, pontual e comprometido com a Instituição. A Coordenação das Atividades de Enfermagem (CAENF), composta pelas diretoras de Divisão de Enfermagem dos Institutos, tem entre seus objetivos a proposta de montar um grupo/recurso para a capacitação e desenvolvimento do pessoal. Dessa forma depreende-se que existe empenho dos enfermeiros e das chefias deenfermagem no desenvolvimento da capacitação profissional. Entretanto, essa disposição não tem sido elemento suficiente para superar as dificuldades de ordem política e econômica que perpassam um Complexo Hospitalar Público.
In a hospital complex is significant the number of nurses working to assist people and also in the leadership jobs and participating in advisory tasks. However, for this type of work, knowledge is not definitive and the professional needs to develop continuous and updating learning. The present qualitative research had the general objective to characterize the profile of the professional capacitating program for nurses in a Teaching Hospital Complex, based on the six directors´ and their six substitutes' perception of the Nursing Division of the Institutes which take part of the central pole of the Hospital Complex of the Clinicas Hospital of the Faculty of Medicine of the São Paulo University (USP), totaling 12 collaborators. The specific objectives were to identify the collaborators' perception about the nurse's profile in the capacitating program and to know the proposals which oriented this process. The Study of a Case was the method of choice whose flexibility allowed to confirm, modify or to improve the knowledge on the studied object thus contributing for the theoretical construction of the respective knowledge domain. Data collection was carried out by means of semi-structured interviews after approval of the study made by the Ethic Committee in Research of the Nursing School at USP and of the Ethic Committee for Analysis of Research Projects of the Clinicas Hospital of the Faculty of Medicine of the São Paulo University and also the signature of the FreeInformed Consent by the collaborators. For analysis of data, the Bardin\'s Content Analysis was used which allowed to rescue the Institutional Policy Categories, Policy of Human Resources Management and the Intervening Elements of the Nurse's Professional Capacitating Program. The results showed that there is no formal institutional policy to capacitate the nurse in all the Institutes; employment of fresh graduate nurses and the remuneration policy are difficult elements in the capacitating program. The counterpart of the teaching institutions appears as a resource to assist the needs of the nurse capacitating program; two Institutes do not have a Continuing Education Program; the demanding profile according to the similar conception of the collaborators is a professional with ethic posture, scientifictechnical knowledge, and ability to deal with the team, assiduous, punctual and engaged with the Institution. The Coordination of the Nursing Activities composed by the directors of the Nursing Division of the Institutes aims to create a group/resource to capacitate and develop the personnel into the institution. Thus, we concluded that there is an effort by the nurses and nursing leadership to professional capacitate their staff, but this effort has not been a sufficient element to surpass their economic and political difficulties inherent to a Public Hospital Complex.