Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Traumatic brain injury registry of Ribeirão Preto (ReTER): validation of the Neurological Outcomes Scale for Traumatic Brain Injury (NOS-TBI) and prospective cohort study

INTRODUÇÃO: Traumatismo cranioencefálico (TCE) é uma das principais causas de morte e incapacidade funcional no Brasil. Entretanto, registros prospectivos em TCE são escassos no país, assim como são limitados os instrumentos validados para avaliação das alterações neurológicas após o TCE. Neste contexto, os objetivos deste estudo foram: realizar a tradução, adaptação cultural e validação do NOS-TBI em pacientes com TCE (parte 1); realizar uma avaliação sistemática e prospectiva dos pacientes com TCE, descrever as características clínicas e demográficas e analisar os fatores preditivos de desfecho funcional após seis meses do TCE (parte 2). MÉTODOS: na primeira parte desta tese realizamos um estudo qualitativo de tradução, adaptação cultural e retrotradução (inglês) e, estudos observacionais de validação e análise das propriedades psicométricas de confiabilidade (consistência interna); validade de critério concorrente (correlação entre NOS-TBI com escalas validadas (Escore de Trauma Revisado (RTS) e a Escala de Coma de Glasgow (ECG)); validade de critério preditiva para analisar o melhor momento que prediz funcionalidade (MIF e NOS-TBI em diferentes momentos); validade convergente para avaliar se NOS-TBI mede o mesmo construto que MIF e a Escala de Resultado de Glasgow Ampliada (GOSE) e confiabilidade entre examinadores para avaliar ao grau de concordância entre a pontuação de dois observadores. Na segunda parte desta tese foi realizadoo um estudo de coorte prospectivo com pacientes admitidos com TCE na Unidade de Emergência do HCFMRP-USP. Estes pacientes foram avaliados durante a internação hospitalar e seguidos por seis meses do TCE para reavaliações clínicas. RESULTADOS: (Parte 1) a versão traduzida e adaptada da escala NOS-TBI mostrou excelente confiabilidade e consistência demonstrada pelo coeficiente Alfa de Cronbach (0,96). A confiabilidade interavaliador foi de 0,73 a 1,0. A validade de critério concorrente apresentou correlações estatisticamente significativas e de forte magnitude entre asescalas ECG e RTS no momento da admissão (r=-0,905, p<0,0001 e r=-0,782, p<0,0001, respectivamente). Avaliações realizadas no momento da alta e aos 30 dias apresentaram maior valor preditivo para funcionalidade. Quanto a validade convergente, verificou-se uma correlação moderada ao comparar o escore total da escala com os escores da MIF e GOSE. (Parte 2) foram incluídos 596 pacientes sendo 80,37% homens, idade média de 40,54±17,37 anos e 75,17% eram economicamente ativos. Quanto a gravidade do TCE, 73,82% foram considerados leve, 6,54% moderado e 19,63% grave. Quanto a causa 56,78% foram decorrentes de acidentes de trânsito e 26,51% de quedas. O consumo de bebida alcoólica foi confirmado em 19,63%. O escore médio de RTS foi de 7,14±1,28 e a letalidade de 12,96%. DISCUSSÃO E CONCLUSÃO: a versão traduzida e adaptada do NOS-TBI mostrou-se válida e confiável para ser aplicada à população brasileira, associandose significativamente a funcionalidade dos pacientes com TCE. Já o perfil dos pacientes com TCE revelou um predomínio de adultos jovens do sexo masculino, vítimas de acidentes trânsito. Desta forma, este estudo forneceu informações relevantes que podem ser utilizadas para o aprimoramento da qualidade da atenção ao paciente com TCE, para o planejamento das ações interdisciplinares e para as estratégias de prevenção e manejo do TCE no Brasil.INTRODUCTION: Traumatic brain injury (TBI) is a leading cause of mortality and functional impairment in Brazil. Prospective registries in traumatic brain injury (TBI) are scarce in the country and there are very limited number of instruments validated for the evaluation of the main neurological dysfunctions related to TBI. In this context, the objectives of this study were: (Part 1) translation, cultural adaptation and validation of NOS-TBI for the evaluation of patients with TBI in Brazil. (Part 2) to identify and analyze the predictive factors of functional outcome of TBI in Brazil at six months. METHODS: (Part 1) we performed a qualitative study of translation, cultural adaptation and back translation (English) of the NOS-TBI, followed by validation and analysis of the psychometric properties of reliability (internal consistency); validity of concurrent criteria (correlation between NOS-TBI with validated scales (Revised Trauma Score (RTS) and Glasgow Coma Scale (ECG); validity of predictive criteria to analyze the best moment to predict functionality (FIM and NOS- TBI at different times), convergent validity to assess whether NOS-TBI measures the same construct as FIM and the Extended Glasgow Outcome Scale (GOSE) and reliability among examiners to assess the degree of agreement between the scores of two observers. (Part 2) We studied a prospective cohort of consecutive patients with TBI, collecting clinical and demographic characteristics in order to analyze the predictive factors of functional outcome of TBI in Brazil at six months. RESULTS: (Part 1) The translated and adapted version of the NOS-TBI instrument showed excellent reliability and consistency assessed by the Cronbach\'s Alpha coefficient (0.96). The inter-rater reliability for patients evaluated during the hospital stay and the clinical outcome after six months of the TBI was good (0.73 to 1). The validity of the concurrent criterion presented statistically significant correlations which had a strong magnitude between the ECG and scales RTS at admission (r=-0.905, p<0.0001 and r=-0.782, p<0.0001, respectively). Evaluation at Discharge and at 30 days showed the highest association to functionality. As for the convergent validity, a moderate correlation was observedwhen comparing the total scale score with the FIM and GOSE scores. Chapter 2: 596 patients were included, 80.37% were men, mean age was 40.54 ± 17.37 years and 75.17% were economically active. Regarding the severity of TBI, 73.82% were considered mild, 6.54% moderate and 19.63% severe. As regards to the cause of TBI, 56.78% were due to traffic accidents and 26.51% of falls. Alcohol ingestion was confirmed at 19.63%. The mean RTS score was 7.14 ± 1.28 and the mortality rate was 12.96%. DISCUSSION AND CONCLUSION: the translated and adapted Portuguese version of NOS-TBI scale was considered valid and reliable to be applied to the Brazilian population and showed significant association to the functionality in patients with TBI. TBI patients in our region are usually young male adults, victims of traffic accidents. Evaluation at hospital discharge can be used to predict functionality. Above all, this study provided relevant information for the improvement the quality of evaluation of the patient with TBI and the hospital care service, planning of interdisciplinary actions and public health strategies in the management of TBI

Predictors of quality of life after moderate to severe traumatic brain injury

ABSTRACT Objective To verify correlations between age, injury severity, length of stay (LOS), cognition, functional capacity and quality of life (QOL) six months after hospital discharge (HD) of victims of traumatic brain injury (TBI). Method 50 patients consecutively treated in a Brazilian emergency hospital were assessed at admission, HD and six months after HD. The assessment protocol consisted in Abbreviated Injury Scale, Injury Severity Score, Glasgow Coma Scale (GCS), Revised Trauma Score (RTS), Mini Mental Test, Barthel Index and World Health Organization QOL - Brief. Results Strong negative correlation was observed between LOS and GCS and LOS and RTS. An almost maximal correlation was found between RTS and GCS and functional capacity and GCS at HD. Age and LOS were considered independent predictors of QOL. Conclusion Age and LOS are independent predictors of QOL after moderate to severe TBI

Notícias de uma guerra: estratégias, ameaças e orações

Neste artigo pretendo abordar algumas questões observadas durante as eleições municipais de 2004 na Baixada Fluminense, fundamentalmente em Nova Iguaçu, focalizando como a religião, em um momento específico, foi apropriada pelo discurso político objetivando sua potencialidade eleitoral. Assim, descreverei alguns conflitos (políticos) em torno de algumas personalidades da/na Baixada e em que medida o auxílio à temática religiosa, fundamentalmente a evangélica, foi importante para reconfigurar o campo político na região durante o segundo turno das eleições municipais.<br>In this article I propose analyze some questions observed in Baixada Fluminense's 2004 election, basically in Nova Iguaçu, giving emphasis on the religion dimension and how it was appropriated by a political discourse with electoral purposes. Then, I will describe some conflicts (political conflicts) about some Baixada's politicians and how the religion was important to reconfigure the political camp during the election