Sponsored multicentric clinical research conducted in Brazil in the respiratory area - losses and gains

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

Prevalence of chronic obstructive pulmonary disease and associated factors: the PLATINO Study in São Paulo, Brazil Prevalência de doença pulmonar obstrutiva crônica e fatores associados: Estudo PLATINO em São Paulo, Brasil

Chronic obstructive pulmonary disease (COPD) is now a major public health concern; deaths attributable to COPD in Latin America have increased by 65.0% in the last decade. This study was aimed at evaluating COPD prevalence and associated factors in adults (> 40 years) living in Greater Metropolitan São Paulo, Brazil. The study is part of the Proyecto Latinoamericano de Investigación en Obstrucción Pulmonar (The PLATINO Project), a multi-center survey on COPD burden in Latin America, with São Paulo as the first center where the project has been carried out. A population-based sample was selected in multiple stages. Spirometry tests were performed in each subject pre- and post-bronchodilator and COPD was mainly defined as the ratio of forced expiratory volume to forced vital capacity below 70.0% (fixed ratio definition). Other spirometric criteria were also used for the diagnosis of COPD. COPD prevalence was 15.8% (95%CI: 13.5-18.1) using the fixed ratio definition. COPD was positively associated with age and smoking and inversely with body mass index. Utilization of different COPD spirometry criteria resulted in different percentages of COPD, but similar associated factors.<br>A doença pulmonar obstrutiva crônica (DPOC) é hoje um grande desafio para a saúde pública; as mortes atribuídas a DPOC na América Latina aumentaram 65,0% na última década. Avaliou-se a prevalência de DPOC e fatores associados em uma população adulta (> 40 anos) da grande área metropolitana de São Paulo, Brasil. Esse estudo faz parte do Proyecto Latinoamericano de Investigación en Obstrucción Pulmonar (Projeto PLATINO), um estudo multicêntrico sobre DPOC em grandes cidades da América Latina, tendo sido São Paulo o primeiro centro onde o projeto se realizou. O estudo foi transversal de base populacional e amostragem em múltiplos estágios. Os indivíduos realizaram espirometria, e DPOC foi basicamente definida como a razão entre o volume expiratório forçado em um segundo (VEF1) e a capacidade vital forçada (CVF) abaixo de 70,0% (relação fixa). Outros critérios espirométricos foram também utilizados para o diagnóstico de DPOC. A prevalência de DPOC foi de 15,8% (IC95%: 13,5-18,1) usando-se o critério mencionado acima. DPOC associou-se positivamente com idade e tabagismo e inversamente com o índice de massa corporal. O uso de diferentes critérios espirométricos acarretou mudanças na freqüência de DPOC, mas não nos fatores associados

Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial Eficacia de la auriculoterapia para la disminución del estrés en estudiantes de enfermería: ensayo clínico aleatorio Eficácia da auriculoterapia para diminuição de estresse em estudantes de enfermagem: ensaio clínico randomizado

This study is a randomized single-blind trial, which aimed to evaluate the efficacy of true auriculotherapy and placebo auriculotherapy in reducing the stress levels of mid-level Nursing students of the School of Nursing of the Beneficência Portuguesa Hospital. Seventy-one students with average, high and very high scores, according to Vasconcellos' List of Stress Symptoms, were divided into three groups: Control (25), Auriculotherapy (24), and Placebo/Sham (22). They were evaluated at the baseline, 8th and 12th sessions and at the follow-up (15 days) and received Shen Men and Brainstem points (Auriculotherapy Group) and Wrist and Outer Ear points (Placebo/Sham Group). The analysis of variance (ANOVA) showed statistically significant differences between the Control/Auriculotherapy groups from the 8th session, which was maintained in the third and fourth evaluations (p=0.000) and between the Control/Placebo groups (p<0.05) at the three evaluations. It was concluded that the true auriculotherapy obtained better responses (45.39%) than the placebo (34.18%) in the reduction of the stress, but further studies are recommended for the re-evaluation of the sham points for stress. ClinicalTrials.gov Identifier: NCT01420848.<br>Este ensayo clínico aleatorio simple-ciego tuvo el objetivo de evaluar la eficacia de la auriculoterapia verdadera y auriculoterapia placebo en la disminución del estrés de los estudiantes de la Escuela de Enfermería del Hospital Beneficência Portuguesa. Setenta y un alumnos com puntuaciones medias, altas y altísimas por la Lista de Síntomas de Estrés de Vasconcellos se dividieron en 3 grupos: Control (25), Auriculoterapia (24), Placebo/Sham (22). Se evaluaron al inicio, con 8, 12 sesiones y seguimiento (15 días). En la ANOVA se encontraron diferencias estadísticamente significativas entre os grupos de Control/Auriculoterapia en las 3 evaluaciones (P=0,000) y entre Control/Placebo (P<0,05). Se concluyó que la auriculoterapia obtuvo mejor respuesta (45,39%) que el placebo (34,18%) en reducir el estrés. Se recomiendan más estudios para la reevaluación de los puntos sham de estrés. ClinicalTrials.gov Identifier: NCT01420848.<br>Trata-se de estudo clínico randomizado, simples cego, com o objetivo de avaliar a eficácia da auriculoterapia verdadeira e placebo na diminuição dos níveis de estresse em alunos de nível médio, da Escola de Enfermagem do Hospital Beneficência Portuguesa. Setenta e um estudantes com escores médio, alto e altíssimo, pela Lista de Sintomas de Estresse de Vasconcellos, foram divididos em 3 grupos: controle (25), auriculoterapia (24) e placebo/Sham (22). Foram avaliados, no início, com 8, 12 sessões e follow-up (15 dias) e receberam os pontos Shen Men, tronco cerebral (auriculoterapia) e punho e ouvido externo (placebo/Sham). Na análise de variância (Anova) constataram-se diferenças estatísticas significativas entre os grupos controle/auriculoterapia a partir de 8 sessões, mantendo-se após a terceira e a quarta avaliação (p=0,000) e entre controle/placebo (p<0,05), nas três avaliações. Concluiu-se que a auriculoterapia verdadeira obteve melhores respostas (45,39%) do que o placebo (34,18%) na redução do estresse, mas recomendam-se mais estudos para reavaliação de pontos Sham para estresse. ClinicalTrials.gov Identifier: NCT01420848