Segurança e tolerabilidade de Nintedanibe em pacientes com fibrose pulmonar idiopática no Brasil / Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis in Brazil

RESUMO Objetivo Ensaios clínicos mostraram que 150 mg de Nintedanibe duas vezes ao dia reduzem a progressão da doença em pacientes com Fibrose Pulmonar Idiopática (FPI), com um perfil de efeitos adversos que é controlável para a maioria dos pacientes. Antes da aprovação do Nintedanibe como tratamento para a FPI no Brasil, um Programa de Acesso Expandido (PEA) foi iniciado para fornecer acesso precoce ao tratamento e avaliar a segurança e a tolerância do Nintedanibe para este grupo de pacientes. Métodos Foram elegíveis para participar da PEA pacientes com diagnóstico de FPI nos últimos 5 anos, com capacidade vital forçada (CVF) ≥ 50% do previsto e capacidade de difusão dos pulmões para monóxido de carbono (DLco) 30%-79% do previsto. Os pacientes receberam Nintedanibe 150 mg, 2 vezes ao dia (bid). As avaliações de segurança incluíram eventos adversos que levaram à suspensão permanente do Nintedanibe e eventos adversos graves. Resultados O PEA envolveu 57 pacientes em 8 centros. A maioria dos pacientes era do sexo masculino (77,2%) e brancos (87,7%). No início do estudo, a média de idade foi de 70,7 (7,5) anos e a CVF foi de 70,7 (12,5%) do previsto. A média de exposição ao Nintedanibe foi de 14,4 (6,2) meses; a exposição máxima foi de 22,0 meses. Os eventos adversos frequentemente relatados pelo pesquisador como relacionados ao tratamento com Nintedanibe foram diarreia (45 pacientes, 78,9%) e náusea (25 pacientes, 43,9%). Os eventos adversos levaram à suspensão permanente do Nintedanibe em 16 pacientes (28,1%) que passaram por um evento adverso grave. Conclusões No PEA brasileiro, o Nintedanibe apresentou um perfil aceitável de segurança e tolerância em pacientes com FPI, condizendo com dados de ensaios clínicos.

ABSTRACT Objective Clinical trials have shown that nintedanib 150 mg twice daily (bid) reduces disease progression in patients with idiopathic pulmonary fibrosis (IPF), with an adverse event profile that is manageable for most patients. Prior to the approval of nintedanib as a treatment for IPF in Brazil, an expanded access program (EAP) was initiated to provide early access to treatment and to evaluate the safety and tolerability of nintedanib in this patient population. Methods Patients with a diagnosis of IPF within the previous five years, forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity of the lungs for carbon monoxide (DLco) 30% to 79% predicted were eligible to participate in the EAP. Patients received nintedanib 150 mg bid open-label. Safety assessments included adverse events leading to permanent discontinuation of nintedanib and serious adverse events. Results The EAP involved 57 patients at eight centers. Most patients were male (77.2%) and white (87.7%). At baseline, mean (SD) age was 70.7 (7.5) years and FVC was 70.7 (12.5) % predicted. Mean (SD) exposure to nintedanib was 14.4 (6.2) months; maximum exposure was 22.0 months. The most frequently reported adverse events considered by the investigator to be related to nintedanib treatment were diarrhea (45 patients, 78.9%) and nausea (25 patients, 43.9%). Adverse events led to permanent discontinuation of nintedanib in 16 patients (28.1%). Sixteen patients (28.1%) had a serious adverse event. Conclusion In the Brazilian EAP, nintedanib had an acceptable safety and tolerability profile in patients with IPF, consistent with data from clinical trials.

Escala CARE de empatia: tradução para o Português falado no Brasil e resultados iniciais de validação / CARE scale of empaty: translation to the Portuguese spoken in Braziland initial validation results

Objetivos: Traduzir e adaptar para uso no Brasil a escala de avaliação de empatia clínica Consultation and Relational Empathy (CARE). Fornecer resultados preliminares de validação concorrente dessa escala. Métodos: A escala em inglês foi traduzida e adaptada seguindo metodologia recomendada. Vinte pacientes atendidos em ambulatório de pneumologia em hospital público ligado ao Sistema Único de Saúde foram entrevistados quanto ao grau de compreensão da versão final do instrumento. Em uma segunda fase, doze pacientes do mesmo ambulatório responderam a versão brasileira da escala CARE e a Escala de Percepção de Empatia Pelo Paciente (EPEP), logo após término de consulta de rotina. Os médicos responsáveis pelo atendimento desses pacientes também foram convidados, após a consulta, a responder questionário contendo a versão brasileira do Interpersonal Reactivity Index (IRI) e o Inventário de Empatia (IE). Resultados: Dezenove dos 20 pacientes referiram grau elevado de compreensão dos itens da versão brasileira da escala CARE. O escore mediano da escala CARE para outros 12 voluntários foi 44,5 (20-63). O coeficiente alfa de Cronbach para as respostas dos últimos foi 0,867. Os escores CARE correlacionaram-se de maneira significante com os escores EPEP (r=0,699; p=0,01) e com o subitem altruísmo do IE (r=0,744, p=0,01). A escala CARE não mostrou correlações significantes com os escores globais das medidas de empatia IRI e IE informados pelos médicos. Conclusão: A versão brasileira da escala CARE é de fácil compreensão e exibe evidências aceitáveis de validade concorrente e consistência interna. Medidas de empatia referidas pelos médicos tendem a não se correlacionar com as percepções dos pacientes.

Objectives: To translate and to adapt the scale Consultation and Relational Empathy (CARE) for using in Brazil. To obtain preliminary results about concurrent validation of this scale. Methods: The scale was translated and adapted from English by appropriated recommended methodology. Twenty patients from the pulmonology clinic of a public hospital, associated with the Brazilian public health system, were interviewed about the degree of understanding of the scale final version. The second step of the study enrolled twelve patients from the same clinic who answered the Brazilian version of CARE and the Perception Scale of Empathy By Patients (EPEP), shortly after the end of aroutine consultation The physicians responsible for the care of these patients were also approached andasked to answer a questionnaire containing the Brazilian version of the Interpersonal Reactivity Index (IRI) and the Inventory of Empathy (IE). Results: Nineteen of 20 patients reported a high degree of understanding about the items of the Brazilian version of CARE. The median CARE score for other 12 volunteers was 44.5 (20-63). The Cronbach’s alpha coefficient for the answers of these patients was 0.867. CARE scores significantly correlated with EPEP scores (r = 0.699, p = 0.01) and with subsection altruism of the IE (r = 0.744, p = 0.01). CARE scale showed no significant correlations with global scores of IE and IRI reported by physicians. Conclusion: The Brazilian version of CARE is easy to understand and displays acceptable evidences of concurrent validity and internal consistency. Measures of empathy reported by doctors tend to not correlate with perceptions of patients.

Estudio situacional de siete revistas latinoamericanas de neumonología / Editorial situation of seven journals on respiratory diseases from Latin America

Objetivo: Caracterizar la situación de las revistas sobre enfermedades respiratorias publicadas en América Latina. Método: Se efectuó una encuesta en una reunión organizada por ALAT (Asociación Latinoamericana de Tórax). Cada editor presentó un informe sobre la revista a su cargo y contestó un cuestionario. Resultados: La principal motivación de las Sociedades de Enfermedades Respiratorias para publicar sus propias revistas es mejorar la adquisición de conocimientos. Las principales motivaciones de los autores para escribir artículos serían difundir el conocimiento médico e informar sobre una experiencia. La deficiencia más frecuente de los manuscritos enviados, es la falta de cumplimiento con las normas de publicación de la revista. El logro de una mejoría en la relación autor-editor-revisor, sería la mejor estrategia para mejorar la calidad de los manuscritos. Entre las sugerencias para mejorar las revistas latino-americanas destacaron: a) profesionalizar el trabajo editorial; b) aumentar la meticulosidad de los revisores de los manuscritos y c) insistir en el cumplimiento de las normas internacionales de edición de revistas médicas. Algunos de los principales problemas informados fueron: a) carencia de periodicidad regular y adecuada en la publicación de cada número de las revistas; b) carencia de manuscritos originales que signifiquen un aporte de real impacto para la especialidad; c) bajo porcentaje de rechazo de manuscritos enviados para su eventual publicación; d) el recambio de editores es elevado y frecuente. Recomendaciones: a) las revistas deberían mantener su formato impreso en papel, aunque estén disponibles en índices electrónicos; b) cada revista debería tener impreso el costo de su suscripción, aunque esté incluido en la cuota anual de membresía de la sociedad; c) no obstante cada país de América Latina pueda decidir publicar su propia revista de enfermedades respiratorias, debe explorarse la factibilidad de generar una revista multinacional...

The situation of respiratory diseases journals published in Latin America was analized by the editors of these journals, convoked by ALAT (Latin American Association of Thoracic Diseases) al Lima, Peru, on February 4th, 2007. Each editor presented a report about his/her journal and answered a survey about to get better manuscripts. Results of the survey improve information acquisition would be the main motivation of national respiratory societies for editing their own journals Disseminate medical knowledge and report an experience, would be the main motivations of authors to submit papers. The most frequent deficiency of manuscripts submitted is bad adherence to journal's requirements. An improvement in the relationship between author-editor-reviewer should be the best strategy to enhance the quality of the manuscripts. Suggestions on how to improve the Latin American journals included: a) professionalize editorial work; b) increase meticulousness of manuscripts reviewers and c) reinforce international norms for editing medical journals. Major problerns reported by editors a) Lack of a regular and adequate periodicity (at least quarterly) in publishing the issues: b) Lack of original papers submitted that mean a "milestone" for the specialty; c) Low percentage of rejection in submitted papers (5 to 39%) indicating an scarce capacity to select excellent papers; d) high and frequent turnover of editors (each two years) which implies a poor accomplishment of editorial regulations and policies. Recommendations a) Although several journals are available in electronic indices, they should be maintained in their printed form, because it is unknown for how long the information could be preserved in an electronic support; b) Each journal should have printed its subscription fee, in spite its subscription is included in the annual society membership fee...

Estudio situacional de siete revistas latinoamericanas de Neumología / Editorial situation of seven Latin American journals on respiratory diseases

A survey was conducted in a meeting sponsored by ALAT (Latin American Association of Thoracic Diseases). Each of the seven editors reported about their journal and answered a questionnaire. The improvement in knowledge divulgation is the main motivation of respiratory societies to edit their own journals. To disseminate medical knowledge and report experiences, are the main motivations of authors to submit papers. The most common deficiency of submitted manuscripts is a bad compliance with journal requirements. An improvement in the relationship between author-editor-reviewer should be the best strategy to enhance the quality of the manuscripts. Suggestions to improve the Latin American journals included to professionalize editorial work, to increase the meticulousness of manuscripts reviewers and to reinforce international norms for editing medical journals. Some major problems reported were a lack of a regular and adequate periodicity in publishing the issues, lack of original papers submitted that mean a "milestone" for the specialty a low percentage of submitted papers rejection and a high and frequent turnover of editors. Although several journals are available in electronic indices, they should be maintained in their printed form. Each journal should have printed its subscription fee, even considering that its subscription is included in the annual society membership fee. The feasibility to generate a multinational Latin American Journal on Respiratory Diseases should be explored.

Estudio situacional de siete revistas latinoamericanas de neumología / Situational study of seven Latin-American pulmonology journals

OBJETIVO: Caracterizar la situación de las revistas de neumología publicadas en Latinoamérica. MÉTODOS: Fue realizada una encuesta en reunión organizada por la Sociedad Latinoamericana de Tórax. Cada editor presentó un reporte y respondió a un cuestionario. RESULTADOS: Mejora en la adquisición de informaciones es la principal motivación para las sociedades de neumología para la edición de sus propias revistas, considerando que la diseminación de conocimiento médico y el reporte de experiencias son los principales motivos para que los autores envíen sus trabajos. El error más común en los trabajos enviados es la poca conformidad con las directrices de la revista. Mejorar las relaciones entre autor, editor y revisor sería la mejor estrategia para perfeccionar la calidad de los textos. Algunas sugerencias para mejorar las revistas latinoamericanas: promover profesionales en tareas editoriales; encorajar a los revisores a que sean más meticulosos; y adoptar normas internacionales para la edición de revistas médicas. Fueron reportados los siguientes problemas: falta de periodicidad adecuada y regular de las ediciones; una disminución en la cantidad de trabajos originales que son considerados ejemplares en la especialidad; baja tasa de rechazo de trabajos enviados; alta rotación de editores. CONCLUSION: Podemos hacer las siguientes recomendaciones: a pesar de varias revistas estar en formato electrónico, ellas también deben ser mantenidas en formato impreso; cada revista debe informar su tasa de suscripción, aunque esté incluida en los gastos de inscripción anual; a pesar de cada país de Latinoamérica poder optar por publicar su propia revista, la posibilidad de publicación de una revista multinacional de neumología latinoamericana debe ser explotada.

OBJECTIVE: To characterize the situation of pulmonology journals published in Latin America. METHODS: A survey was conducted in a meeting sponsored by the Latin American Thoracic Society. Each journal editor presented a report and answered a questionnaire. RESULTS: Improving information acquisition is the main motivation for pulmonology societies to edit their own journals, whereas disseminating medical knowledge and reporting experiences are the main motivations for authors to submit papers. The most common failing in the manuscripts submitted is poor compliance with the journal guidelines. Improving author-editor-reviewer relationships would be the best strategy for improving the quality of manuscripts. Suggestions for improving Latin American journals included the following: promoting professionalism in editorial tasks; encouraging manuscript reviewers to be more meticulous; and embracing international norms for editing medical journals. The following major problems were reported: a lack of regular, appropriate periodicity of issues; a shortage of original papers that are considered 'milestones' in the specialty; a low rejection rate for submitted papers; a high turnover of editors. CONCLUSION: Based on our findings, we can make the following recommendations: although many journals are available in electronic form, they should also be maintained in print form; each journal should divulge its subscription fee, even if it is included in the annual society membership dues; although each Latin American country might decide to publish its own pulmonology journal, the feasibility of publishing a multinational Latin American pulmonology journal should be explored.

Estudio situacional de siete revistas latinoamericanas de neumología / Situational study of seven latinamerican journals on pneumology

Objetivo: Caracterizar la situación de las revistas de enfermedades respiratorias publicadas en América Latina. Métodos: El estudio se realizó en una reunión patrocinada por ALAT (Asociación Latinoamericana de tórax). Cada editor presentó un reporte sobre su revista y contestó un cuestionario. Resultados: Mejorar la adquisición de información sería la principal motivación de las sociedades respiratorias para editar sus propias revistas; diseminar el conocimiento médico y reportar sus experiencias sería la principal motivación para los autores al enviar sus escritos. La principal deficiencia de los artículos sometidos es la mala adherencia a los requisitos de publicación. Una mejoría en la relación entre autor, editor, revisor podría ser la mejor estrategia para mejorar la calidad de los artículos. Sugerencias para mejorar las revistas latinoamericanas incluyen: a) Profesionalizar el trabajo editorial, b) Incrementar la meticulosidad de los revisores y c) Reforzar las normas internacionales para la publicación de revistas médicas. Los mayores problemas reportados fueron: a) Falta de periodicidad adecuada en la publicación de la revista. b) Falta de artículos originales lo que significa un hito para la especialidad, c) Bajo porcentaje de rechazo de los artículos sometidos d) cambio frecuente de los editores. Recomendaciones: Aunque muchas revistas estan disponibles en medio electrónico debería conservarse la impresión en físico, b) Cada revista debería tener impreso el costo de la suscripción independiente de que este incluida en el costo anual de la membresía a la sociedad. c) No obstante que cada país latinoamericano puede decidir el publicar su propia revista, la factibilidad de generar una revista Latinoamericana de Enfermedades respiratorias.