Assessment of Androgen Receptor Splice Variant-7 as a Biomarker of Clinical Response in Castration-Sensitive Prostate Cancer.

PURPOSE: Therapies targeting the androgen receptor (AR) have improved the outcome for patients with castration-sensitive prostate cancer (CSPC). Expression of the constitutively active AR splice variant-7 (AR-V7) has shown clinical utility as a predictive biomarker of AR-targeted therapy resistance in castration-resistant prostate cancer (CRPC), but its importance in CSPC remains understudied. EXPERIMENTAL DESIGN: We assessed different approaches to quantify AR-V7 mRNA and protein in prostate cancer cell lines, patient-derived xenograft (PDX) models, publicly available cohorts, and independent institutional clinical cohorts, to identify reliable approaches for detecting AR-V7 mRNA and protein and its association with clinical outcome. RESULTS: In CSPC and CRPC cohorts, AR-V7 mRNA was much less abundant when detected using reads across splice boundaries than when considering isoform-specific exonic reads. The RM7 AR-V7 antibody had increased sensitivity and specificity for AR-V7 protein detection by immunohistochemistry (IHC) in CRPC cohorts but rarely identified AR-V7 protein reactivity in CSPC cohorts, when compared with the EPR15656 AR-V7 antibody. Using multiple CRPC PDX models, we demonstrated that AR-V7 expression was exquisitely sensitive to hormonal manipulation. In CSPC institutional cohorts, AR-V7 protein quantification by either assay was associated neither with time to development of castration resistance nor with overall survival, and intense neoadjuvant androgen-deprivation therapy did not lead to significant AR-V7 mRNA or staining following treatment. Neither pre- nor posttreatment AR-V7 levels were associated with volumes of residual disease after therapy. CONCLUSIONS: This study demonstrates that further analytical validation and clinical qualification are required before AR-V7 can be considered for clinical use in CSPC as a predictive biomarker.

Translation and cross-cultural adaptation of the Arizona Sexual Scale (ASEX) into Portuguese / Tradução e adaptação transcultural da Arizona Sexual Scale (ASEX) para a língua portuguesa

Abstract Introduction Sexual dysfunction is common in individuals with psychiatric disorders and under psychotropic medication such as antidepressants and antipsychotics. Several scales have been developed to assess sexual function in these patients. The Arizona Sexual Scale (ASEX) is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. We describe the translation and cross-cultural adaptation of the ASEX into the Portuguese language, with the goal of contributing to the assessment of sexual function in Portuguese-speaking psychiatric patients under treatment with psychotropic drugs. Methods The translation and cross-cultural adaptation process thoroughly followed the steps recommended by the Task Force of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), namely: preparation, forward translation, reconciliation, back-translation, back-translation review, harmonization, cognitive debriefing, review of cognitive debriefing, finalization, proofreading, and final version. Results The process was successfully completed and no major differences were found between the translation, reconciliation and back-translation phases, with only small adjustments being made. Conclusion The translation of the ASEX was completed successfully, following international reference guidelines. The use of these guidelines is a guarantee of a Portuguese version that is qualitatively and semantically equivalent to the original scale. This availability of this new scale version will enable studies evaluating the sexual function of Portuguese-speaking psychiatric patients. Future studies may assess the validity of the scale for Portuguese-speaking populations.

Resumo Introdução A disfunção sexual é comum em indivíduos com doenças psiquiátricas e sob o uso de medicações como antidepressivos e antipsicóticos. Várias escalas foram desenvolvidas para avaliar a função sexual desses doentes. A Arizona Sexual Scale (ASEX) é uma escala de cinco itens de avaliação que quantifica desejo sexual, excitação, lubrificação vaginal/ereção peniana, capacidade para atingir o orgasmo e satisfação com o orgasmo. Este artigo descreve o processo de tradução e adaptação transcultural da escala ASEX para a língua portuguesa, com o objetivo de contribuir para a avaliação da função sexual dos doentes medicados com fármacos psicotrópicos nos vários países onde se utiliza essa língua. Métodos A tradução e a adaptação transcultural seguiram de forma detalhada os passos recomendados pelo grupo de trabalho da International Society for Pharmacoeconomics and Outcomes Research (ISPOR), nomeadamente: preparação, tradução inicial, reconciliação, retroversão, revisão da retroversão, harmonização, teste cognitivo, revisão do teste cognitivo, finalização, leitura final e versão final. Resultados O processo foi completado com sucesso, e não foram observadas diferenças grandes entre as fases de tradução, reconciliação e retroversão, tendo sido feitos apenas pequenos ajustes. Conclusão A tradução da escala ASEX foi bem-sucedida, seguindo orientações internacionais de referência. A aplicação dessas orientações é a garantia de uma versão em língua portuguesa que é qualitativa e semanticamente equivalente à versão original da escala. A existência desta nova versão da escala permitirá estudos que avaliem a função sexual dos doentes em países nos quais se fale a língua portuguesa. Estudos futuros poderão atestar a validade da escala para essas populações.

Translation and cross-cultural adaptation of the Arizona Sexual Scale (ASEX) into Portuguese.

INTRODUCTION: Sexual dysfunction is common in individuals with psychiatric disorders and under psychotropic medication such as antidepressants and antipsychotics. Several scales have been developed to assess sexual function in these patients. The Arizona Sexual Scale (ASEX) is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. We describe the translation and cross-cultural adaptation of the ASEX into the Portuguese language, with the goal of contributing to the assessment of sexual function in Portuguese-speaking psychiatric patients under treatment with psychotropic drugs. METHODS: The translation and cross-cultural adaptation process thoroughly followed the steps recommended by the Task Force of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), namely: preparation, forward translation, reconciliation, back-translation, back-translation review, harmonization, cognitive debriefing, review of cognitive debriefing, finalization, proofreading, and final version. RESULTS: The process was successfully completed and no major differences were found between the translation, reconciliation and back-translation phases, with only small adjustments being made. CONCLUSION: The translation of the ASEX was completed successfully, following international reference guidelines. The use of these guidelines is a guarantee of a Portuguese version that is qualitatively and semantically equivalent to the original scale. This availability of this new scale version will enable studies evaluating the sexual function of Portuguese-speaking psychiatric patients. Future studies may assess the validity of the scale for Portuguese-speaking populations.

O emprego das tecnologias leves no cuidado ao hipertenso na Estratégia Saúde da Família / The use of soft technologies in the care of hypertensive patients in Family Health Strategy

Objective: To analyze the use of soft technologies in the care of hypertensive patients in the Family Health Strategy. Method: Descriptive study with qualitative approach. A total of 14 hypertensives and 2 professionals from a Family Health team in a municipality in the interior of the state of Ceará, Brazil, participated in the study in 2016. Data were collected through a checklist for non-participant systematic observation, subsidized by a field diary, being treated by the Thematic Content Analysis. Results: The categories constructed were: Relational technologies in the care of the hypertensive in the FHS and communication process between health-hypertensive professional in the FHS. In care practices permeate soft technologies, relationships; soft-hard, technical knowledge; and hard, the material resources, and verbal communication predominates in interpersonal relationships, to the detriment of nonverbal signals. Conclusion: There is a need to strengthen communication skills and soft technologies to re-signify the production of health care.

Objetivo: Analizar el empleo de las tecnologías leves en el cuidado al hipertenso en la Estrategia Salud de la Familia. Método: Estudio descriptivo con enfoque cualitativo. Participaron 14 hipertensos y dos profesionales de un equipo de Salud de la Familia en un Municipio del interior del Estado de Ceará, Brasil, 2016. Los datos fueron recolectados por checklist para observación sistemática no participante y diario de campo, tratados por el Análisis de Contenido Temático. Resultados: Emergieron las categorías: Tecnologías relacionales en el cuidado al hipertenso en la ESF y proceso de comunicación entre profesional-hipertenso en la ESF. En las prácticas del cuidado impregna las tecnologías leves, relaciones; leve-duras, conocimiento técnico; y duras, recursos materiales y la comunicación verbal predominan en las relaciones interpersonales, en detrimento del lenguaje no verbal. Conclusión: Es necesario fortalecer las habilidades de comunicación y las tecnologías leves para re-significar la producción de la atención en la salud.

Objetivo: Analisar o emprego das tecnologias leves no cuidado ao hipertenso na Estratégia Saúde da Família. Método: Descritivo com abordagem qualitativa. Participaram da pesquisa 14 hipertensos e dois profissionais de uma equipe de Saúde da Família em um município do interior do estado do Ceará, Brasil, em 2016. Os dados foram coletados por um checklist para observação sistemática não participante, subsidiados por um diário de campo, tratados pela Análise de Conteúdo Temática. Resultados: As categorias construídas foram: Tecnologias relacionais no cuidado ao hipertenso na ESF e processo de comunicação entre profissional de saúde-hipertenso na ESF. Nas práticas do cuidado, permeiam as tecnologias leves, as relações; leves-duras, o conhecimento técnico; e duras, os recursos materiais, e a comunicação verbal predomina nas relações interpessoais, em detrimentos dos sinais não verbais. Conclusão: Urge a necessidade de fortalecer as habilidades de comunicação e as tecnologias leves para ressignificar a produção do cuidado em saúde.

Assessment of the Cavidi ExaVir Load Assay for Monitoring Plasma Viral Load in HIV-2-Infected Patients.

HIV plasma viral load is an established marker of disease progression and of response to antiretroviral therapy, but currently there is no commercial assay validated for the quantification of viral load in HIV-2-infected individuals. We sought to make the first clinical evaluation of Cavidi ExaVir Load (version 3) in HIV-2-infected patients. Samples were collected from a total of 102 individuals living in Cape Verde, and the HIV-2 viral load was quantified by both ExaVir Load and a reference in-house real-time quantitative PCR (qPCR) used in Portugal in 91 samples. The associations between viral load and clinical prognostic variables (CD4+ T cell counts and antiretroviral therapy status) were similar for measurements obtained using ExaVir Load and qPCR. There was no difference between the two methods in the capacity to discriminate between nonquantifiable and quantifiable HIV-2 in the plasma. In samples with an HIV-2 viral load quantifiable by both methods (n = 27), the measurements were highly correlated (Pearson r = 0.908), but the ExaVir Load values were systematically higher relative to those determined by qPCR (median difference, 0.942 log10 copies/ml). A regression model was derived that enables the conversion of ExaVir Load results to those that would have been obtained by the reference qPCR. In conclusion, ExaVir Load version 3 is a reliable commercial assay to measure viral load in HIV-2-infected patients and therefore a valuable alternative to the in-house assays in current use.

Therapeutic communication in the interaction between health workers and hypertensive patients in the family health strategy. / Comunicação terapêutica na interação profissional de saúde e hipertenso na estratégia saúde da família.

OBJECTIVE To analyze the therapeutic communication in the interaction between health professionals and hypertensive patients in the Family Health Strategy. METHODS Descriptive study with qualitative approach. The sample consisted of 14 hypertensive patients and two health professionals of the Family Health Strategy (ESF - "Estratégia Saúde Família") in a city of the state of Ceará, Brazil, in 2016. In the data collection, a checklist was used for non-participant systematic observation containing the strategies of therapeutic communication, namely: expression, clarity, validation, and a field diary, being these subjected to content analysis. RESULTS It was noted that ESF professionals do not adequately use therapeutic communication, indicating the need of investment in this device, which acts as a bridge for users, enhances care practices and opens paths that instrumentalize interpersonal relationships. CONCLUSIONS It was realized that health professionals are not fully exploring therapeutic communication strategies, therefore being necessary to develop skills to use these techniques correctly when caring for hypertensive patients.

Comunicação terapêutica na interação profissional de saúde e hipertenso na estratégia saúde da família / Comunicación terapêutica na interacción profesional de saúde y hipertenso na estratégia saúde da família / Therapeutic communication in the interaction between health workers and hypertensive patients in the family health strategy

Resumo OBJETIVO Analisar a comunicação terapêutica na interação entre profissional de saúde e paciente hipertenso na Estratégia Saúde da Família. MÉTODOS Estudo descritivo com abordagem qualitativa. A amostra constituiu-se de 14 pacientes hipertensos e dois profissionais da ESF em um município do Estado do Ceará, Brasil, em 2016. Na coleta de dados, utilizou-se um checklist para observação sistemática não participante contendo as estratégias de comunicação terapêutica: expressão, clarificação, validação e um diário de campo, sendo tratados pela análise de conteúdo. RESULTADOS Verificou-se que os profissionais da ESF não utilizam de forma adequada a comunicação terapêutica, reconhecendo a necessidade de investimento nesse dispositivo, que atua como ponte de acesso aos usuários, potencializa as práticas assistenciais e abre caminhos que instrumentalizam as relações interpessoais. CONCLUSÕES Desvelou-se que as estratégias de comunicação terapêutica são pouco exploradas pelos profissionais de saúde, sendo necessário, portanto, desenvolver habilidades para empregá-las adequadamente no cuidado ao hipertenso.

Resumen OBJETIVO Analizar la comunicación terapéutica entre el profesional de la salud y pacientes hipertensos en la Estrategia de Salud de la familia. MÉTODOS Estudio descriptivo con enfoque cualitativo. La muestra estuvo constituida por 14 pacientes hipertensos y dos profesionales del Estrategia de Salud de la Familia (ESF - "Estratégia Saúde Família") de un municipio del estado de Ceará, Brasil, en 2016. En la recopilación de datos, seutilizó una lista de verificación para la observación sistemática no participante la cual contiene las estrategias de comunicación terapéutica: expresión, claridad, validación y un diario de campo que trata del análisis de contenido. RESULTADOS Se comprobó que los profesionales del ESF no utilizan de manera adecuada la comunicación terapéutica, reconociéndose la necesidad de inversión en este dispositivo que actúa como puente para el acceso a los usuarios, realza las prácticas asistenciales y abre caminos que instrumentalizan las relaciones interpersonales. CONCLUSIONES Se reveló que las estrategias de comunicación terapéutica son poco aplicadas por los profesionales de la salud que las requieren, por lo tanto, se hace necesario desarrollar destrezas para utilizarla correctamente en el cuidado de los pacientes hipertensos.

Abstract OBJECTIVE To analyze the therapeutic communication in the interaction between health professionals and hypertensive patients in the Family Health Strategy. METHODS Descriptive study with qualitative approach. The sample consisted of 14 hypertensive patients and two health professionals of the Family Health Strategy (ESF - "Estratégia Saúde Família") in a city of the state of Ceará, Brazil, in 2016. In the data collection, a checklist was used for non-participant systematic observation containing the strategies of therapeutic communication, namely: expression, clarity, validation, and a field diary, being these subjected to content analysis. RESULTS It was noted that ESF professionals do not adequately use therapeutic communication, indicating the need of investment in this device, which acts as a bridge for users, enhances care practices and opens paths that instrumentalize interpersonal relationships. CONCLUSIONS It was realized that health professionals are not fully exploring therapeutic communication strategies, therefore being necessary to develop skills to use these techniques correctly when caring for hypertensive patients.