The brazilian registry of adult patient undergoing cardiovascular surgery, the bypass project: results of the first 1,722 patients

Abstract Objective: To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Methods: Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. Results: 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systems; and 7.3% from private (out-of -pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%; for CABG was 2.6%, and for valve operations, 4.4%. Conclusion: This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols.

Sponsored multicentric clinical research conducted in Brazil in the respiratory area - losses and gains / Pesquisas clínicas multicêntricas patrocinadas realizadas na área respiratória no Brasil - Perdas e ganhos

Summary Objective: To evaluate the sponsored centers for clinical trial in the respiratory care setting in Brazil: profile; logistics and structure. Methods: Principal investigators (29) and subinvestigators (30) of 39 research centers completed the questionnaires that addressed personal identification and training of researchers, the centers' facilities and advantages and/or disadvantages of performing sponsored trials. Results: 75.6% of the centers were located in southern and southeastern Brazil. Most principal investigators were men with a mean age of 53.4 years. The clinical trials in the respiratory care setting focus on asthma and chronic obstructive pulmonar disease (COPD). 80% of the researchers cited delay of the Conep and Anvisa as a barrier to performing research. The advantages of participating in clinical trials were updating knowledge of the researcher and the team, and additional income for the team. The main disadvantages mentioned by the researchers included low financial compensation for the performed workload, and time availability. The median number of professionals per research center was six people, predominantly physicians. Conclusion: The number of research centers in the respiratory care setting in Brazil is still relatively small. The teams have good training for performing the clinical trials. Asthma and COPD are the most studied diseases in sponsored clinical trials. The main barrier is delay by the Conep and Anvisa. The factors that lead investigators to participate range from being updated along with the team, to site and staff financial issues; the main disadvantage is the low compensation for the required workload demand.

Resumo Objetivo: avaliar nos centros de pesquisas clínicas patrocinadas na área respiratória no Brasil o perfil, a logística e a estrutura. Método: questionários foram respondidos por pesquisadores principais (29) e subinvestigadores (30) de 39 centros de pesquisa relativos a identificação e formação dos pesquisadores, instalações dos centros e vantagens e desvantagens quanto à participação nas pesquisas patrocinadas. Resultados: setenta e cinco por cento (75,6%) dos centros se localizavam nas regiões Sul e Sudeste do Brasil. A maioria dos investigadores principais eram homens com média de idade de 53,4 anos. As pesquisas na área respiratória se concentravam no estudo da asma e da doença pulmonar obstrutiva crônica (DPOC). Oitenta por cento dos pesquisadores citaram a demora na Comissão Nacional de Ética em Pesquisa (Conep) e na Agência Nacional de Vigilância Sanitária (Anvisa) como fator de entrave para a realização das pesquisas. As vantagens em participar das pesquisas clínicas foram a atualização própria ou da equipe envolvida, com rendimento adicional para a equipe. A principal desvantagem apontada pelos pesquisadores foi a baixa compensação financeira em relação ao volume de trabalho e disponibilidade de tempo. A mediana de profissionais por centro de pesquisa foi de seis pessoas, com predominância de médicos. Conclusão: o número de centros na área respiratória no Brasil ainda é relativamente pequeno. As equipes apresentam boa formação para a realização das pesquisas. Asma e DPOC são as doenças mais estudadas pelas pesquisas clínicas patrocinadas. O principal entrave é a demora da Conep e da Anvisa. Os fatores que levam os investigadores a participarem variam desde atualização própria/equipe até questões financeiras para a equipe e o centro; a principal desvantagem relatada é a baixa remuneração diante da demanda de trabalho exigida.

O programa de controle da tuberculose em Pelotas/RS, Brasil: investigação de contatos intradomiciliares / The tuberculosis control program in Pelotas/RS, Brazil: home contact investigations / El programa de control de la tuberculosis de Pelotas/RS, Brasil: investigación de contactos intradomiciliarios

Objetivou-se avaliar as ações de investigação dos contatos intradomiciliares dos casos índices de tuberculose (TB) no Programa de Controle da Tuberculose (PCT), de Pelotas/RS - Brasil. Trata-se de um estudo descritivo de corte transversal, com dados do prontuário dos casos índices. A amostra foi constituída por 163 contatos de 68 indivíduos com TB pulmonar em tratamento no PCT, entre junho e agosto de 2009. Os contatos eram, predominantemente, do sexo feminino, com idade acima dos 10 anos e filhos dos casos índices. Os exames solicitados foram a radiografia de tórax e a baciloscopia. Verificou-se a presença da doença ativa em 1,8% dos contatos. Os resultados evidenciam que a atenção à TB, em Pelotas/RS - Brasil, centralizada em um único serviço especializado, dificulta a investigação dos contatos intradomiciliares, necessitando envolver a atenção primária, para aproximar os profissionais da família e facilitar o diagnóstico precoce e a interrupção da cadeia de transmissão da TB em tempo oportuno.

The aim of this study is to evaluate the investigation actions of home contacts of tuberculosis (TB) index cases in the Tuberculosis Control Program (TCP) of Pelotas/RS - Brazil. This cross-sectional descriptive study was based on data from the records of index cases. The sample consisted of 163 contacts of 68 subjects with pulmonary TB in treatment in the TCP between June and August, 2009. These contacts were predominantly female, over 10 years of age and the daughters of index cases. The requested examination was a chest radiography and bacilloscopy. Active TB was found in 1.8 % of contacts. Results show that assistance for TB patients in Pelotas-Brazil, which is centralized in a single specialized service, hinders the investigation of home contacts. Primary care is required to narrow the gap between professionals and the family, and facilitate early diagnosis and interruption of the TB transmission chain in a timely manner.

El objetivo fue evaluar las acciones de investigación de los contactos intradomiciliaros de casos índices de tuberculosis (TB), en el Programa de Control de Tuberculosis (PCT) de Pelotas/RS - Brasil. Se trata de un estudio descriptivo de corte transversal, con datos del prontuario de los casos índices. La muestra fue constituida por 163 contactos de 68 sujetos con TB pulmonar en tratamiento en el PCT, entre julio y agosto de 2009. Los contactos eran predominantemente del sexo femenino, con edad superior a los 10 años e hijos del caso índice. Los exámenes solicitados fueron Rayos X del tórax y baciloscopia. Se verificó la presencia de la enfermedad activa en un 1,8% de los contactos. Los resultados evidencian que la atención a TB en Pelotas-Brasil, centralizada en un único servicio especializado, dificulta la investigación de los contactos intradomiciliarios, necesitando abarcar la atención primaria, para aproximar a los profesionales de la familia y facilitar el diagnóstico precoz y la interrupción de la cadena de transmisión de la TB en tiempo oportuno.

The impact of losartan on the lifetime incidence of ESRD and costs in Mexico / El impacto del losartan en la incidencia de por vida de la enfermedad renal de la etapa terminal y sus costos en México

Background. The RENAAL (Reduction of Endpoints in Type 2 Diabetes with the Angiotensin II Antagonist Losartan) study demonstrated that treatment with losartan reduced the risk of ESRD by 29% among hypertensive patients with type 2 diabetes and diabetic nephropathy. The objective of this study was to project the effect of losartan compared to placebo on the lifetime incidence of ESRD and associated costs from a third-party payer perspective in Mexico. Methods. A competing risks method was used to estimate lifetime incidence of ESRD, while accounting for the risk of death without ESRD. The cost associated with ESRD was estimated by combining the cumulative incidence of ESRD with the lifetime cost associated with ESRD. Total cost was estimated as the sum of the cost associated with ESRD from the three main public institutions in Mexico, the lifetime cost of losartan therapy, and other costs (non-ESRD/non-losartan) expected for patients with type 2 diabetes. Survival was estimated by weighting the life expectancies with and without ESRD by the cumulative risk of ESRD. Results. The projected lifetime incidence of ESRD for losartan patients was lower (66%) compared with placebo patients (83%). This reduction in ESRD resulted in a decrease in ESRD-related cost of M$49,737 per patient and a discounted gain of 0.697 life years per patient. After accounting for the cost of losartan and the additional cost associated with greater survival, we projected that treatment with losartan would result in a net savings of M$24,073 per patient. Conclusion. Treatment with losartan in patients with type 2 diabetes and nephropathy not only reduced the within-trial incidence of ESRD but is projected to result in lifetime reductions in ESRD, increased survival, and overall cost savings to public institutions in Mexico.

Antecedentes. El estudio RENAAL (Reducción de los grados o puntos terminales en la diabetes tipo 2 con losartan, el antagonista de la anglotenslna II) demostró que el tratamiento con losartan redujo el riesgo de la ESRD (enfermedad renal de la etapa terminal) en 29% entre pacientes hipertensos con diabetes tipo 2 y neuropatía diabética. El propósito estudiado fue hacer una proyección del efecto del losartan comparándolo con el placebo en la incidencia de por vida de la ESRD y con los costos asociados de un tercer pagador en perspectiva en México. Métodos. Se utilizó un método de riesgos muy competitivo para calcular la incidencia de por vida de la ESRD, al mismo tiempo que se calculaba el riesgo de muerte sin la ESRD. El costo asociado con la ESRD se calculó confirmando la incidencia acumulativa de la ESRD en relación con el costo de por vida de la terapia con losar-tan y otros costos (sin ESRD o sin losartan) con los que se contaba para pacientes con diabetes tipo 2. La supervivencia se calculó esperando las expectativas de vida con y sin ESRD por el riesgo acumulativo de ESRD. Resultados. La proyectada incidencia de por vida de la ESRD en cuanto a los pacientes con losartan fue más baja (66%) comparada con los pacientes que tomaron placebo (83%). Esta reducción de la ESRD tuvo por resultado una disminución en el costo relacionado con la ESRD de $49,737 por paciente y una ganancia descartada de 0.697 años de vida por paciente. Luego de contabilizar el costo del losartan y el costo añadido asociado con una mayor supervivencia, llegamos a la conclusión de que el tratamiento con losartan daría por resultado un ahorro neto de $24,073 por paciente. Conclusión. El tratamiento mediante losartan en pacientes aquejados de diabetes tipo 2 y neuropatía no sólo redujo la incidencia intraexperimental de la ESRD, sino que además nos ha servido para proyectar que resulte en reducciones de por vida en la ESRD, en una supervivencia incrementada y en un ahorro total de costos en cuanto a las instituciones públicas en nuestro país.