Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt

O STF e a construção institucional das autoridades reguladoras do financeiro: um estudo de caso das ADIns The Brazilian Supreme Court and the institutional design of the public authorities of the National Financial System: an ADIns' empirical study

Este artigo pretende avaliar a atuação da corte constitucional brasileira, o Supremo Tribunal Federal, como verdadeiro ator no desenho institucional das autoridades reguladoras do sistema financeiro nacional, o Conselho Monetário Nacional (CMN) e o Banco Central do Brasil (BCB). Sua interação com os poderes políticos, por meio do julgamento de Ações Diretas de Inconstitucionalidade (ADIns), ao longo dos últimos 20 anos, forneceu balizas jurídicas para a construção dessas autoridades. Esta pesquisa, que parte de uma análise qualitativa das decisões do Tribunal como estudo de caso, mapeou os temas e atores interessados na regulação do sistema financeiro e na estrutura dessas entidades, assim como procurou demonstrar como a atuação da corte reforçou a competência normativa desses órgãos. Ao final, este artigo delineia parâmetros para eventual edição de futura legislação, que vise regular o sistema financeiro, revogando a Lei 4594 de 1964, e conceder eventual autonomia ao Banco Central do Brasil.<br>The purpose of this study is to analyse the manner the Brazilian Supreme Court's (Supremo Tribunal Federal - STF) decisions have influenced the institutional design of the national monetary council and the Brazilian Central Bank. During the last 20 years, STF provided limits to the power of these public authorities, by judging Direct Actions of Unconstitutionality (ADIns). This research is based on empirical study that intends to identify the actors and the issues submitted to the court and how its decision enforced their power of regulating the financial system. As a result, it is possible to perceive directions to enact the law that intends to regulate the financial system and eventually to attribute the independence to the Brazilian Central Bank

Judiciário: mudanças e reformas

O JUDICIÁRIO brasileiro, diferentemente do que ocorria no passado, está na berlinda e não apresenta mais condições de impedir mudanças. Reformas virão e mudanças já estão em curso, algumas mais e outras menos visíveis, alterando a identidade e o perfil de uma instituição que sempre teve na tradição uma garantia segura contra as inovações.<br>THE JUDICIAL Branch of the Brazilian government, unlike in the past, is now in a not-so-flattering spotlight and no longer able to prevent changes. Reforms will come and changes are already happening, some more and some less visible, altering the identity and the profile of an institution that had always counted on tradition as an assured guarantee against innovation