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

The performance of the Mini-Cog in a sample of low educational level elderly

Abstract Objectives: To study the criterion validity of the Mini-Cog in low educational level elderly. Design: Cross-sectional and validation design. Setting: Policlínica Piquet Carneiro, an outpatient unit of Rio de Janeiro State University Hospital, in Brazil. Participants: A convenient sample consisting of 306 individuals, 65 yrs or older, selected from April 8th to July 15th, 2002. Methods: All participants underwent comprehensive geriatric evaluations which included the Mini-Mental State Examination (MMSE) and the cognitive part of the Cambridge Examination for Mental Disorders of the Elderly - Revised (CAMCOG-R). They were classified as demented or non-demented (DSM-IV). A post-hoc analysis was performed on the data from the 3 word recall test of the MMSE, and the Clock Drawing Test from the CAMCOG-R, and respective scores were added and interpreted in accordance with the Mini-Cog protocol. Results: 293 individuals completed all the study steps; 211 had 4 or less years of schooling and were included in the data analysis. 32% had dementia. Mini-Cog sensitivity and specificity was consistently low independently of the different cut-off points considered. The best performance was found at the cut-off point of 2/3 which yielded sensitivity and specificity of 60% and 65%, respectively. Conclusion: The Mini-Cog is not a good cognitive screening tool for individuals with less than five years of formal education

The Clock Drawing Test: performance among elderly with low educational level O Teste do Desenho do Relógio: desempenho entre idosos de baixa escolaridade

OBJECTIVE: To compare the accuracy of four scales, and to determine the inter-rater reliability and the influence of schooling on Clock Drawing Test performance in screening for dementia in elderly with low educational level. METHOD: Design: Criterion validation, concurrent type. Setting: Outpatient unit of Universidade do Estado do Rio de Janeiro Hospital, Brazil. Participants: A total of 306 individuals (> 65 years) were assessed by a geriatrician and a neuropsychologist using functional and cognitive instruments. The diagnosis of dementia was established by consensus in a meeting between these professionals. Four different researchers blinded as to the cognitive status of the patients scored the Clock Drawing Test using Shulman's, Sunderland's, Manos', and Wolf-Klein's methods; and a fifth researcher assessed Manos' method for an inter-rater reliability study. RESULTS: The data of 211 individuals (≤ 4 years of schooling) were analyzed. The sensitivity and specificity of the four methods were similar (about 65%). The inter-rater reliability of Manos' method was excellent (ICC = 0.944). The areas under the ROC curves were small (0.657 to 0.681), and the differences between them were not statistically significant. CONCLUSIONS: The Clock Drawing Test is a reliable but not valid test to screen for dementia in older outpatients with 4 or less years of formal schooling.OBJETIVO: Comparar a acurácia de quatro escalas de avaliação e determinar a confiabilidade inter-aferidor e a influência da escolaridade, no desempenho do Teste do Desenho do Relógio para detecção de demência em idosos com baixo nível educacional. MÉTODO: Delineamento de estudo: Validação de critério, tipo concorrente. Local de estudo: Ambulatório do Hospital da Universidade do Estado do Rio de Janeiro, Brasil. Participantes: 306 indivíduos (> 65 anos) submetidos à avaliação funcional e cognitiva por um geriatra e um neuropsicólogo; uma reunião de consenso entre estes profissionais avaliou a presença de demência. Quatro pesquisadores, que desconheciam o status cognitivo dos indivíduos, pontuaram o Teste do Desenho do Relógio - métodos de Shulman, Sunderland, Manos e Wolf-Klein, e um quinto pesquisador repetiu o método de Manos para o estudo de confiabilidade inter-aferidor. RESULTADOS: 211 indivíduos (≤ 4 anos de escolaridade) tiveram seus dados analisados. A sensibilidade e a especificidade dos quatro métodos foram similares e variaram em torno de 65%. A confiabilidade inter-avaliador foi excelente (ICC = 0,944). As áreas sob as curvas ROC foram pequenas (0,657 a 0,684) e as diferenças entre elas não foram estatisticamente significativas. CONCLUSÕES: O Teste do Desenho do Relógio é um instrumento confiável, mas não é válido para o rastreio de demência em pacientes idosos com quatro anos ou menos de escolaridade

Adaptação transcultural da Escala de Independência em Atividades da Vida Diária (Escala de Katz) Cross-cultural adaptation of the Independence in Activities of Daily Living Index (Katz Index)

Desenvolvimento e análise do desempenho de uma adaptação transcultural para o português da Escala de Katz de independência em atividades da vida diária. Duas traduções e duas retrotraduções analisaram as equivalências conceitual, de itens e semântica para a escolha da versão final. A equivalência operacional foi avaliada em um estudo piloto, testando-se a confiabilidade e a consistência interna da versão adaptada por meio de reteste no mesmo dia em 156 pacientes ou após sete dias da primeira entrevista. A resolução de diferenças sutis em alguns itens levou à equivalência cultural. A versão final foi considerada fácil de se entender e de aplicar. A concordância corrigida para o acaso (kappa ponderado) foi de 0,91. O alfa de Chronbach variou de 0,80 a 0,92. A versão em português da Escala de Katz de independência em atividades da vida diária, completamente desenvolvida e testada, provou ser equivalente à original em inglês. Os itens apresentaram consistência interna e as taxa foram confiáveis.<br>This study involved the development and performance assessment of a cultural adaptation of the Katz scale of independence in activities of daily living, translated into Portuguese in Brazil. Two translations and two back-translations of the items were analyzed by experts in order to decide on the final version. Operational equivalence was assessed in a pilot study. The reliability and internal consistency of the adapted version were assessed by retesting 156 patients on the same day or 7 days after the first interview. Cultural equivalence was achieved after resolving subtle differences in some items. The final version was considered easy to understand and use. Chance-corrected agreement (weighted kappa) was 0.91. Cronbach's alpha ranged from 0.80 to 0.92. CONCLUSIONS: a Portuguese version of the Katz scale of independence in activities of daily living, thoroughly developed and tested, proved equivalent to the original version in English. The items were internally consistent and the rates were reliable

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

NEOTROPICAL CARNIVORES: a data set on carnivore distribution in the Neotropics

Mammalian carnivores are considered a key group in maintaining ecological health and can indicate potential ecological integrity in landscapes where they occur. Carnivores also hold high conservation value and their habitat requirements can guide management and conservation plans. The order Carnivora has 84 species from 8 families in the Neotropical region: Canidae; Felidae; Mephitidae; Mustelidae; Otariidae; Phocidae; Procyonidae; and Ursidae. Herein, we include published and unpublished data on native terrestrial Neotropical carnivores (Canidae; Felidae; Mephitidae; Mustelidae; Procyonidae; and Ursidae). NEOTROPICAL CARNIVORES is a publicly available data set that includes 99,605 data entries from 35,511 unique georeferenced coordinates. Detection/non-detection and quantitative data were obtained from 1818 to 2018 by researchers, governmental agencies, non-governmental organizations, and private consultants. Data were collected using several methods including camera trapping, museum collections, roadkill, line transect, and opportunistic records. Literature (peer-reviewed and grey literature) from Portuguese, Spanish and English were incorporated in this compilation. Most of the data set consists of detection data entries (n = 79,343; 79.7%) but also includes non-detection data (n = 20,262; 20.3%). Of those, 43.3% also include count data (n = 43,151). The information available in NEOTROPICAL CARNIVORES will contribute to macroecological, ecological, and conservation questions in multiple spatio-temporal perspectives. As carnivores play key roles in trophic interactions, a better understanding of their distribution and habitat requirements are essential to establish conservation management plans and safeguard the future ecological health of Neotropical ecosystems. Our data paper, combined with other large-scale data sets, has great potential to clarify species distribution and related ecological processes within the Neotropics. There are no copyright restrictions and no restriction for using data from this data paper, as long as the data paper is cited as the source of the information used. We also request that users inform us of how they intend to use the data