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

Mental health outcomes in frontline healthcare workers in Brazil during the COVID-19 epidemic: results of an online survey in four regions using respondent-driven sampling (RDS)

National Institute of Science and Technology for Health Technology Assessment (IATS) (CNPQ Project: 465518/2014-1), and MCTIC/CNPq/FNDCT/MS/ SCTIE/Decit (MCTIC/CNPq/FNDCT/MS/SCTIE/Decit N◦ 07/2020).Federal University of Rio Grande do Sul. Graduate Program in Epidemiology. Porto Alegre, RS, Brazil / National Institute of Science and Technology for Health Technology Assessment. Porto Alegre, RS, Brazil.Federal University of Rio Grande do Sul. Graduate Program in Epidemiology. Porto Alegre, RS, Brazil / National Institute of Science and Technology for Health Technology Assessment. Porto Alegre, RS, Brazil.Federal University of Ceará. Department of Community Health. Fortaleza, CE, Brazil.Federal University of Ceará. Department of Community Health. Fortaleza, CE, Brazil / Tulane University School of Public Health and Tropical Medicine. New Orleans, Louisiana, USA.Fortaleza University. Graduate Program in Public Health. Fortaleza, CE, Brazil.Federal University of Rio Grande do Sul. Graduate Program in Epidemiology. Porto Alegre, RS, Brazil / National Institute of Science and Technology for Health Technology Assessment. Porto Alegre, RS, Brazil.Pontifícia Universidade Católica do Rio Grande do Sul. Medical School. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Porto Alegre, RS, Brazil.Federal University of Ceará. Department of Community Health. Fortaleza, CE, Brazil.Fundação Oswaldo Cruz. Insitute Aggeu Magalhaes. Recife, PE, Brazil.Ministério da Saúde. Secretaria de Vigilância em Saúde e Ambiente. Instituto Evandro Chagas. Ananindeua, PA, Brasil.Santa Casa de São Paulo. School of Medical Sciences. São Paulo, SP, Brazil.Fundação Oswaldo Cruz. Insitute Aggeu Magalhaes. Recife, PE, Brazil.National Institute of Science and Technology for Health Technology Assessment. Porto Alegre, RS, Brazil / Hospital Moinhos de Vento. Porto Alegre, RS, Brazil / Hospital de Clínicas de Porto Alegre. Porto Alegre, RS, Brazil.Federal University of Rio Grande do Sul. Statistics Department. Porto Alegre, RS, Brazil / Hospital de Clínicas de Porto Alegre. Porto Alegre, RS, Brazil.Background: The COVID-19 pandemic overwhelmed health facilities and presented healthcare workers (HCWs) with a new infectious disease threat. In addition to a sanitary crisis, Brazil still had to face major political, economic, and social challenges. This study aimed to investigate mental health outcomes in frontline HCWs in different regions of the country and at different epidemic times. We also sought to identify the main risk factors associated with these outcomes. Methods: A cross-sectional online survey using respondent-driven sampling was conducted to recruit physicians (n = 584), nurses (n = 997), and nurse technicians (n = 524) in 4 regions of Brazil (North, Northeast, Southeast, and South) from August 2020 to July 2021. We used standardized instruments to screen for common mental disorders (CMD)(SRQ-20), alcohol misuse (AUDIT-C), depression (PHQ-9), anxiety (GAD-7), and post-traumatic stress disorder (PTSD)(PCL-5). Gile’s successive sampling estimator was used to produce weighted estimates. We created a three-cluster data set for each HCW category and developed a hierarchical regression model with three levels: individual characteristics; workplace-related aspects; COVID-19 personal experience. The impact of the epidemic moment on the outcomes was also studied. Results: The prevalence of probable CMD was 26.8–36.9%, alcohol misuse 8.7–13.6%, depression 16.4–21.2%, anxiety 10.8–14.2%, and PTSD 5.9–8.0%. We found a stronger association between mental health outcomes and the following factors: history of psychiatric disorders, female gender, and clinical comorbidities (level 1); work overload and family isolation (level 2); sick leave (level 3). Epidemic variables, such as the number of deaths and trend of deaths by COVID-19, had almost no impact on the outcomes. Conclusion: An alarmingly high prevalence of depression and anxiety was found in Brazilian frontline HCWs. Individual factors were the most strongly associated with mental health outcomes. These findings indicate the need to develop programs that provide emotional support, identify professionals at risk and refer them to specialized treatment when necessar