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

A Multi-Site Study of Traumatic Brain Injury in Mexico and Colombia: Longitudinal Mediational and Cross-Lagged Models of Family Dynamics, Coping, and Health-Related Quality of Life

Latin America has high rates of traumatic brain injury (TBI), yet reduced mental and physical health outcomes due to limited rehabilitation services. To understand the psychosocial adjustment process in TBI patients in Latin America, the incorporation of cultural values including family-based variables is imperative. The current study examined relations among healthy family dynamics, coping, and mental and physical health related quality of life (HRQL) among a sample of TBI patients across three sites and two countries over the first 4 months post-injury. A sample of 109 acute TBI patients from Mexico and Colombia were recruited, and a series of longitudinal mediation and cross-lag panel analyses were run. Mental and physical HRQL were positively associated with each other, as well as healthy family dynamics and coping. Coping partially mediated the effects of healthy family dynamics on both mental and physical HRQL. Family dynamics showed the strongest cross-lag relationships with coping going from 2 months to 4 months. Similarly, coping showed the strongest cross-lag relationships with both mental and physical HRQL going from baseline to 2 months. Results provide empirical support for the importance of a rehabilitation workforce that has been trained in and can effectively implement family-based interventions for individuals with TBI in Latin America

Suicidal Ideation After Acute Traumatic Brain Injury:A Longitudinal Actor-Partner Interdependence Model of Patients and Caregivers in Latin America

Traumatic brain injury (TBI) is associated with depression, anxiety, and even suicidality in individuals with TBI and in caregivers. Moreover, emotional functioning in individuals with TBI is linked with caregiver functioning. However, no known studies to date have examined linkages in suicidal ideation in individuals with TBI and family caregivers. This is especially important in Latin America, where TBI rates are high, and where cultural norms influence family caregiving. This study examined associations among self-reported suicidal ideation in individuals with TBI and their primary caregivers over time in Mexico and Colombia. Research Method/Design: A total of 109 individuals and their primary caregivers completed measures during hospitalization for TBI and at 2 and 4-months posthospitalization. The primary outcome was Item 9 from the Spanish version of the Patient Health Questionnaire-9, assessing for thoughts of death or suicide in the previous 2 weeks. Results: Patients and caregivers reported high levels of suicidal ideation (18.3%–22.4% and 12.4%–15.7%, respectively) at each time point, and suicidal ideation at one time point strongly predicted ideation at the next. When patients endorsed suicidal ideation in the hospital, their caregivers tended to endorse suicidal ideation 2 months later. Although unaccounted for variables could be driving these relationships, they may also provide possible evidence of causal preponderance between patient and caregiver suicidal ideation post-TBI. Conclusions/Implications: Clinicians and rehabilitation specialists can use these findings to inform suicide risk assessment by expanding these practices to caregivers of patients who endorsed suicidal ideation. Interventions after TBI should incorporate caregivers given this study showed significant interdependence of suicidality between patients and caregiver

Relationship Satisfaction and Depression After Traumatic Brain Injury An Actor-Partner Interdependence Model of Patients and Caregivers in Mexico and Colombia

#nofulltext#Objective Traumatic brain injury represents a major public health concern, particularly in low- and middle-income countries like in Latin America. Family members are often caregivers for individuals with traumatic brain injury, which can result in significant stress. Research is needed to examine depression and quality of the caregiving relationship in these dyads. This study examined relationship quality and depression longitudinally after traumatic brain injury within the caregiving relationship. Design Dyads (N= 109) composed of individuals with traumatic brain injury and their caregivers were recruited from three hospitals in Mexico and Colombia. They self-reported depression and relationship satisfaction during hospitalization and at 2 and 4 mos after hospitalization. Results A 2-lag Actor Partner Interdependence Model demonstrated that patients and caregivers reporting high relationship satisfaction at baseline experienced lower depression 2 mos later, which then predicted higher caregiver relationship satisfaction at 4 mos. Moreover, patients with high relationship satisfaction at baseline had caregivers with lower depression at 2 mos, which was then associated with patients' higher satisfaction at 4 mos. Conclusions Within individuals with traumatic brain injury and caregivers, depression and relationship satisfaction seem to be inversely related. Furthermore, patients' and caregivers' depression and relationship satisfaction impact each other over time, demonstrating interdependence within the caregiving relationshi

Yellow fever reemergence in Venezuela – Implications for international travelers and Latin American countries during the COVID-19 pandemic

Fundación Universitaria Autónoma de las Américas. Faculty of Medicine. Grupo de Investigacíon Biomedicina. Pereira, Risaralda, Colombia / Colombian Association of Infectious Diseases. Committe on Tropical Medicine, Zoonoses and Travel Medicine. Bogota, Colombia / Fundación Universitaria Autónoma de las Américas. Grupo de Investigacíon GISCA. Semillero de Zoonosis. Sede Pereira, Pereira, Risaralda, Colombia / Instituto para la Investigación en Ciencias Biomédicas. Emerging Infectious Diseases and Tropical Medicine Research Group. Pereira, Risaralda, Colombia / Pan-American Association of Infectious Diseases. Committe on Travel Medicine. Panama City, Panama / Universidad Cientifica del Sur. Master of Clinical Epidemiology and Biostatistics. Lima, Peru / Institución Universitaria Visión de las Américas. Faculty of Medicine. Grupo de Investigacón Biomedicina. Pereira, Risaralda, Colombia / Institución Universitaria Visión de las Américas. Grupo de Investigación GISCA. Semillero de Zoonosis. Sede Pereira, Pereira, Risaralda, Colombia.Colombian Association of Infectious Diseases. Committe on Tropical Medicine, Zoonoses and Travel Medicine. Bogota, Colombia / Fundación Universitaria Autónoma de las Américas. Grupo de Investigacíon GISCA. Semillero de Zoonosis. Sede Pereira, Pereira, Risaralda, Colombia / Instituto para la Investigación en Ciencias Biomédicas. Emerging Infectious Diseases and Tropical Medicine Research Group. Pereira, Risaralda, Colombia / Institución Universitaria Visión de las Américas. Grupo de Investigación GISCA. Semillero de Zoonosis. Sede Pereira, Pereira, Risaralda, Colombia.Pan-American Association of Infectious Diseases. Committe on Travel Medicine. Panama City, Panama / Instituto Conmemorativo Gorgas de Estudios de la Salud. Clinical Research Deparment. Investigador SNI Senacyt Panama. Panama City, Panama.Pan-American Association of Infectious Diseases. Committe on Travel Medicine. Panama City, Panama / University of Colorado Anschutz Medical Center. Department of Medicine. Division of Infectious Diseases. Aurora, CO, USA / Hospital Infantil de México. Federico Góomez, Méexico City, Mexico.Biomedical Research and Therapeutic Vaccines Institute. Ciudad Bolivar, Venezuela.Colombian Association of Infectious Diseases. Committe on Tropical Medicine, Zoonoses and Travel Medicine. Bogota, Colombia / Universidad de Cordoba. Instituto de Investigaciones Biológicas del Trópico. Colombia.Colombian Association of Infectious Diseases. Committe on Tropical Medicine, Zoonoses and Travel Medicine. Bogota, Colombia / Pan-American Association of Infectious Diseases. Committe on Travel Medicine. Panama City, Panama / Hospital Universitario de Sincelejo. Infectious Diseases and Infection Control Research Group. Sincelejo, Sucre, Colombia / Universidad del Atlático. SUE Caribe. Programa del Doctorado de Medicina Tropical. Barranquilla, Colombia.Colombian Association of Infectious Diseases. Committe on Tropical Medicine, Zoonoses and Travel Medicine. Bogota, Colombia / Universidad Cooperativa de Colombia. Grupo de Investigación en Ciencias Animales. Bucaramanga, Colombia.Fundación Universitaria Autónoma de las Américas. Faculty of Medicine. Grupo de Investigacíon Biomedicina. Pereira, Risaralda, Colombia / Colombian Association of Infectious Diseases. Committe on Tropical Medicine, Zoonoses and Travel Medicine. Bogota, Colombia / Instituto para la Investigación en Ciencias Biomédicas. Emerging Infectious Diseases and Tropical Medicine Research Group. Pereira, Risaralda, Colombia / Pan-American Association of Infectious Diseases. Committe on Travel Medicine. Panama City, Panama / Fundación Universitaria Autónoma de las Américas. Faculty of Medicine. Semillero de Investigación en Infecciones Emergentes y Medicina Tropical. Pereira, Risaralda, Colombia / Institución Universitaria Visión de las Américas. Faculty of Medicine. Grupo de Investigacón Biomedicina. Pereira, Risaralda, Colombia.Instituto Médico La Floresta. Caracas, Venezuela.Universidad del Norte and Hospital Universidad del Norte. Department of Medicine, Health Sciences Division. Barranquilla, Colombia.Pan-American Association of Infectious Diseases. Committe on Travel Medicine. Panama City, Panama / Universidad Central de Venezuela. Faculty of Medicine. Caracas, Venezuela.Institute of Infectious Diseases Emilio Ribas, São Paulo, SP, Brazil.Universidad Estatal del Sur de Manabí. Carrera de Laboratorio Clínico. Cantón Jipijapa, Ecuador.Universidad Católica del Maule. Vicerrectoría de Investigación y Postgrado. Chile.Universidad Central de Venezuela. Faculty of Medicine. Hospital Universitario de Caracas. Department of Internal Medicine. Cardiology Division. Caracas, Venezuela.Hospital José María Vargas. La Guaira, Vargas, Venezuela.Universidad Castilla La Mancha. Facultad de Medicina. Complejo Hospitalario Universitario de Albacete. Servicio de Anatomía Patológica. Albacete, Spain.International Airport Camilo Daza. Health Care Service. Cúcuta, Norte de Santander, Colombia.Universidade de São Paulo. Faculdade de Saúde Pública. Departamento de Epidemiologia. São Paulo, SP, Brazil.Universidad Técnica de Ambato. Ambato, Ecuador.Hospital Transfrontalier Cerdayna. Catalonia, Spain.University of Illinois. Department of Internal Medicine. Division of Infectious Diseases. Chicago, IL, USA.Hospital Evangélico de Montevideo. Montevideo, Uruguay.Universidad Cooperativa de Colombia. Grupo de Investigación en Ciencias Animales. Bucaramanga, Colombia.Instituto Nacional de Salud del Niño San Borja. Infectious Diseases Division. Lima, Peru / Universidad Privada de Tacna. Facultad de Ciencias de la Salud. Tacna, Peru.Hospital Universitario Departamental de Nariño. Pasto, Nariño, Colombia.Universidad de Manizales. School of Medicine. Coordination of Microbiology. Manizales, Caldas, Colombia / Grupo de Resistencia Antibiótica de Manizales. Manizales, Caldas, Colombia.Clínica San Josée. Cúcuta, Norte de Santander, Colombia / Hospital Universitario Erasmo Meoz. Cúcuta, Norte de Santander, Colombia.Hospital de Niños J. M. de Los Ríos. Division of Infectious Diseases. Caracas, Venezuela / Venezuelan Society of Infectious Diseases. Executive Board. Caracas, Venezuela.University of Colorado Anschutz Medical Center. Department of Medicine. Division of Infectious Diseases. Aurora, CO, USA.Universidad Industrial de Santander. Department of Internal Medicine. Bucaramanga, Santander, Colombia.Ministério da Saúde. Secretaria de Vigilância em Saúde. Instituto Evandro Chagas. Ananindeua, PA, Brasil / aq Universidade Federal do Para. Faculdade de Medicina. Belém, PA, Brasil.Hospital de Infecciosas F. Muñíz. Buenos Aires, Argentina.GSK Vaccines. Clinical Research & Development and Medical Affairs. Rio de Janeiro, RJ, Brazil.Hospital de Trauma y Emergencias Federico Abete. Buenos Aires, Argentina.Hospital Británico de Buenos Aires. Buenos Aires, Argentina.Pontificia Universidad Católica de Chile. School of Medicine. Department of Pediatric Infectious Diseases and Immunology. Santiago de Chile, Chile.Hospital de Infecciosas F. Muñíz. Buenos Aires, Argentina.Hospital de Infecciosas F. Muñíz. Buenos Aires, Argentina / Universidad de Buenos Aires. Buenos Aires, Argentina.Latin American Society for Travel Medicine. Panel of Sports and Travel. Buenos Aires, Argentina.Universidad Internacional SEK. Health Sciences Faculty. Research Group of Emerging Diseases, Ecoepidemiology and Biodiversity. Quito, Ecuador / Universidad Central de Venezuela. Facultad de Ciencias. Instituto de Zoología y Ecología Tropical. Caracas, Venezuela.Pan-American Association of Infectious Diseases. Committe on Travel Medicine. Panama City, Panama / Instituto de Investigaciones Biomédicas. Clínica IDB Cabudare. Department of Infectious Diseases and Tropical Medicine. Lara, Venezuela / Venezuelan Science Incubator and the Zoonosis and Emerging Pathogens Regional Collaborative Network. Infectious Diseases Research Branch. Lara, Venezuela / Instituto de Estudios Avanzados. Laboratorio de Señalización Celular y Bioquímica de Parásitos. Caracas, Caracas, Venezuela / Academia Nacional de Medicina. Caracas, Venezuela / The Mount Sinai Hospital-Icahn School of Medicine at Mount Sinai. Department of Pathology, Molecular and Cellbased Medicine. Direction of Microbiology. New York, USA

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.13Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt