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

Cultural adaptation and validation of the scale to measure the care skill of family caregivers of people with chronic disease for the brazilian context

INTRODUCTION: Family caregivers of people with chronic diseases often experience life changes, which may impact on their ability to provide care. In this context, knowing the skills of the caregivers is relevant, aiming to help it through assistance actions and improving the quality of care provided, besides their quality of life. In 2008, the researcher Lucy Barrera Ortiz created and validated the first version of the instrument “Habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica” and in 2014 the author made available the second version of the instrument, after testing the psychometric properties of it and named it “Escala para medir la habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica”. The author authorized us to do the process of translation, adaptation and validation of the scale in Brazil. The process began in 2016 and the stages of cultural adaptation and validation of the scale were developed in this master's research from 2017. OBJECTIVE: To adapt and validate the “Escala para medir la habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica” to the Brazilian context". METHODS: This is a methodological study that followed the steps recommended by Beaton et al. (2000). The process happened with the stages of translation, synthesis of translations, back-translation, reviewed by a committee of experts and pre-testing. After its cultural adaptation, the Brazilian version was titled “Escala para medir a habilidade de cuidado de cuidadores familiares de pessoas com doença crônica” (Escala HCCF-DC) and then were analyzed the psychometric properties of reliability (internal consistency) and validity (convergent and discriminant) of the same. All ethical precepts have been respected (Opinion No. 1,435,698). In the present research, three articles derived from the study will be presented, which specifically aimed to: 1. Identify in the literature instruments that measure the care ability of the family caregiver of people with chronic disease; 2. To translate and culturally adapt the “Escala para medir a habilidade de cuidado de cuidadores familiares de pessoas com doença crônica” for the Brazilian context; 3. Evaluate the reliability and construct validity of the Brazilian version of the HCCF-DC Scale. RESULTS: In the systematic review of the literature, we found three instruments to measure family caregiver care ability: Caring Ability Inventory, Habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica and Home Health Care Competence Instrument "GCPC-UN-CPC. In the process of cultural adaptation of the “Escala para la medir a habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica”, all items of the scale were reviewed by a committee composed of seven specialists, in which the content validity index (IVC) ) of 1.00 in 41 items, IVC = 0.86 in three items and IVC = 0.71 in four items. After the adequacy of the seven items, the pre-test was applied to 14 family caregivers of people with chronic kidney disease (CKD), adjusting the verb tense of the items to the present indicative, to facilitate the understanding of the items by the population target, reaching the final version of the HCCF-DC Scale. This version was tested for its internal consistency and construct validity. It was observed good reliability of the domains and total of the scale, with Cronbach's alpha ≥ 0,70. In addition, the scale presented discriminative capacity of caregivers' care ability according to the quality of life (worse and better) and the presence of anxious and depressive symptoms. In addition, we hypothesized the relationship between the scale measure with domains of another instrument to measure care ability (Caregivers' Skill Inventory) and overload and dependence for instrumental activities of the family's daily life, thus indicating validity of the convergent and discriminant construct of the HCCF-DC Scale when applied to 107 family caregivers of people with CKD on hemodialysis. CONCLUSION: The HCCF-DC Scale demonstrated reliability and validity of a convergent and discriminant construct when applied to family caregivers of people with CKD. Further research is recommended to verify the psychometric performance of the scale in Brazil, as well as other instruments of measurement of the ability of care found in the literature review, thus consolidating their reliability and validity. In addition, there is a need to broaden the knowledge about the caregiver's ability to care in Brazil and in the world, as well as related aspects.Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)INTRODUÇÃO: Os cuidadores familiares de pessoas com doenças crônicas vivenciam frequentemente transformações na vida, as quais podem impactar em sua habilidade para prestação do cuidado. Neste contexto, conhecer a habilidade no cuidado dos cuidadores é relevante, almejando auxiliá-lo por meio de ações assistenciais e melhorando a qualidade do cuidado prestado, além de sua qualidade de vida. Em 2008, a pesquisadora Lucy Barrera Ortiz criou e validou a primeira versão do instrumento “Habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica” e em 2014 a autora disponibilizou a segunda versão da escala, após testar as propriedades psicométricas do mesmo, intitulando-o de “Escala para la medir a habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica”. A autora autorizou que fizéssemos o processo de tradução, adaptação e validação da escala no Brasil e o processo se iniciou em 2016 e as etapas de adaptação cultural e validação da escala foram desenvolvidas nesta pesquisa de mestrado a partir de 2017. OBJETIVO: Adaptar e validar a Escala para la medir a habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica para o contexto brasileiro. MÉTODOS: Trata-se de um estudo metodológico, que seguiu as etapas preconizadas por Beaton et al. (2000). O processo deu-se por meio das fases de tradução, síntese das traduções, retrotradução, revisão por um comitê de especialistas e pré-teste. Após sua adaptação cultural, a versão brasileira foi intitulada de “Escala para medir a habilidade de cuidado de cuidadores familiares de pessoas com doença crônica” (Escala HCCF-DC) e em seguida foram analisadas as propriedades psicométricas de confiabilidade (consistência interna) e validade de construto (convergente e discriminante) da mesma. Todos os preceitos éticos foram respeitados (Parecer n. 1.435.698). Na presente pesquisa, serão apresentados três artigos derivados do estudo, os quais almejaram especificamente: 1. Identificar na literatura instrumentos que mensuram a habilidade de cuidado do cuidador familiar de pessoas com doença crônica; 2. Traduzir e adaptar culturalmente a Escala para medir la habilidad de cuidado de cuidado de cuidadores familiares de personas con enfermedad crónica para o contexto brasileiro; 3. Avaliar a confiabilidade e a validade de construto da versão brasileira da Escala HCCF-DC. RESULTADOS: Na revisão sistemática da literatura foram encontrados três instrumentos de medida da habilidade de cuidado do cuidador familiar: Caring Ability Inventory, Habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica e Home health care competence instrument “GCPC-UN-CPC”. No processo adaptação cultural da “Escala para la medir a habilidad de cuidado de cuidadores familiares de personas con enfermedad crónica” foram revistos todo os itens da escala por um comitê composto por sete especialistas, no qual obteve-se índice de validade de conteúdo (IVC) de 1,00 em 41 itens, IVC=0,86 em três itens e IVC=0,71 em quatro itens. Após a adequação dos sete itens, aplicou-se o pré-teste com 14 cuidadores familiares de pessoas com doença renal crônica (DRC), adequando-se o tempo verbal dos itens para o presente do indicativo, para facilitar a compreensão dos itens pela população alvo, chegando-se à versão final da Escala HCCF-DC. Esta versão foi testada em relação à sua consistência interna e validade de construto. Observou-se boa confiabilidade dos domínios e total da escala, com alfa de Cronbach ≥ 0,70. A escala apresentou capacidade discriminativa da habilidade de cuidado dos cuidadores, segundo a qualidade de vida (pior e melhor) e a presença de sintomas ansiosos e depressivos. Além disso, confimaram-se as hipóteses de relação da medida da escala com domínios de outro instrumento de medida da habilidade de cuidado (Inventário de Habilidade de Cuidador) e de sobrecarga e dependência para atividades instrumentais de vida diária do familiar, indicando-se assim validade de construto convergente e discriminante da Escala HCCF-DC quando aplicada em 107 cuidadores familiares de pessoas com DRC em hemodiálise. CONCLUSÃO: A Escala HCCF-DC evidenciou confiabilidade e validade de construto convergente e discriminante quando aplicada em cuidadores familiares de pessoas com DRC. Recomenda-se novas pesquisas para se verificar o desempenho psicométrico da escala no Brasil, assim como de outros instrumentos de medida da habilidade de cuidado encontrados na revisão da literatura, consolidando-se assim a confiabilidade e validade dos mesmos. Além disso, há a necessidade de ampliação dos conhecimentos sobre a habilidade de cuidado do cuidador no Brasil e no mundo, assim como dos aspectos relacionados

Adaptação da Escala para Medir a Habilidade de Cuidado de Cuidadores Familiares de Pessoas com Doença Crônica no Brasil

13 páginasObjetivo: traducir y adaptar culturalmente la Escala para Medir la Habilidad de Cuidado de Cuidadores Familiares de Personas con Enfermedad Crónica para el contexto brasileño. Materiales y método: se trata de un estudio metodológico que siguió las etapas preconizadas por Dorcas Beaton para traducción y adaptación cultural de la referida escala en Brasil. Todos los principios éticos se respetaron. Resultados: la traducción inicial del instrumento para el portugués se realizó por dos traductores; luego, se estableció la versión consensual, la que se retrotradujo al español por otro traductor independiente. El comité de expertos contó con siete profesionales del área de la salud, obteniéndose índice de Validez de contenido (IVC) = 1,00 en 41 ítems, IVC = 0,86 en tres ítems y IVC = 0,71 en cuatro ítems. Tras la adecuación de los siete ítems, se aplicó la preprueba con 14 cuidadores familiares de personas con enfermedad crónica; de ahí, se logró encontrar las dificultades de los participantes y, así, revisar los ítems. Conclusiones: terminado el proceso de traducción y adaptación, se obtuvo la versión brasileña del instrumento titulada “Escala para Medir a Habilidade de Cuidado de Cuidadores Familiares de Pessoas com Doença Crônica”

Adapting the Scale to Measure Care Ability of Family Caregivers of People with Chronic Diseases in Brazil

Adaptación de la Escala para Medir la Habilidad de Cuidado de Cuidadores Familiares de Personas con Enfermedad Crónica en Brasil*Adaptação da Escala para Medir a Habilidade de Cuidado de Cuidadores Familiares de Pessoas com Doença Crônica no Brasil*Objective: To translate and culturally adapt the Scale to Measure the Care Ability of Family Caregivers of People with Chronic Diseases to the Brazilian context. Materials and Methods: This is a methodological study that followed the steps recommended by Dorcas Beaton for translating and culturally adapting this scale in Brazil. All ethical precepts have been respected. Results: The first translation of the instrument into Brazilian Portuguese was done by two translators; the consensual version was then established, which was back-translated into Spanish by another independent translator. The committee of specialists comprised seven health professionals, obtaining a content validity index (CVI) = 1.00 in 41 items, CVI = 0.86 in three items and CVI = 0.71 in four items.  After adjusting the seven items, a pretest was applied to 14 family caregivers of people with chronic kidney disease. Based on this, the participants’ difficulties were observed, and then the items were reviewed. Conclusions: After the translation and adaptation process was completed, the Brazilian version of the instrument entitled “Scale to Measure the Care Ability of Family Caregivers of People with Chronic Diseases” was obtained.To reference this article / Para citar este artículo / Para citar este artigoDamasceno VAM, Zazzetta MS, Orlandi FS. Adapting the Scale to Measure the Care Ability of Family Caregivers of People with Chronic Diseases in Brazil. Aquichan 2019;19(4):e1948. DOI: https://doi.org/10.5294/aqui.2019.19.4.8Recibido: 17/02/2019Aceptado: 01/09/2019Online: 05/12/2019* This study was funded by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Capes). The first author was awarded a grant from this agency.  This study was also funded by the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brazil.Adaptación de la Escala para Medir la Habilidad de Cuidado de Cuidadores Familiares de Personas con Enfermedad Crónica en Brasil*Adaptação da Escala para Medir a Habilidade de Cuidado de Cuidadores Familiares de Pessoas com Doença Crônica no Brasil*Objetivo: traducir y adaptar culturalmente la Escala para Medir la Habilidad de Cuidado de Cuidadores Familiares de Personas con Enfermedad Crónica para el contexto brasileño. Materiales y método: se trata de un estudio metodológico que siguió las etapas preconizadas por Dorcas Beaton para traducción y adaptación cultural de la referida escala en Brasil. Todos los principios éticos se respetaron. Resultados: la traducción inicial del instrumento para el portugués se realizó por dos traductores; luego, se estableció la versión consensual, la que se retrotradujo al español por otro traductor independiente. El comité de expertos contó con siete profesionales del área de la salud, obteniéndose índice de Validez de contenido (IVC) = 1,00 en 41 ítems, IVC = 0,86 en tres ítems y IVC = 0,71 en cuatro ítems. Tras la adecuación de los siete ítems, se aplicó la preprueba con 14 cuidadores familiares de personas con enfermedad crónica; de ahí, se logró encontrar las dificultades de los participantes y, así, revisar los ítems. Conclusiones: terminado el proceso de traducción y adaptación, se obtuvo la versión brasileña del instrumento titulada “Escala para Medir a Habilidade de Cuidado de Cuidadores Familiares de Pessoas com Doença Crônica”.To reference this article / Para citar este artículo / Para citar este artigoDamasceno VAM, Zazzetta MS, Orlandi FS. Adapting the Scale to Measure the Care Ability of Family Caregivers of People with Chronic Diseases in Brazil. Aquichan 2019;19(4):e1948. DOI: https://doi.org/10.5294/aqui.2019.19.4.8Recibido: 17/02/2019Aceptado: 01/09/2019Online: 05/12/2019* Este artículo tuvo apoyo financiero de la Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Capes), por medio de una beca concedida a la primera autora, y del Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brasil.Adaptación de la Escala para Medir la Habilidad de Cuidado de Cuidadores Familiares de Personas con Enfermedad Crónica en Brasil*Adaptação da Escala para Medir a Habilidade de Cuidado de Cuidadores Familiares de Pessoas com Doença Crônica no Brasil*Objetivo: traduzir e adaptar culturalmente a Escala para Medir la Habilidad de Cuidado de Cuidadores Familiares de Personas con Enfermedad Crónica para o contexto brasileiro. Materiais e método: trata-se de um estudo metodológico que seguiu as etapas preconizadas por Dorcas Beaton para tradução e adaptação cultural da referida escala no Brasil. Todos os preceitos éticos foram respeitados. Resultados: a tradução inicial do instrumento para o português brasileiro realizou-se por dois tradutores; em seguida, estabeleceu-se a versão consensual, a qual se retrotraduziu para o espanhol por outro tradutor independente. O comitê de especialistas contou com sete profissionais da área da saúde, obtendo-se índice de validade de conteúdo (IVC) = 1,00 em 41 itens, IVC = 0,86 em três itens e IVC = 0,71 em quatro itens. Após a adequação dos sete itens, aplicou-se o pré-teste com 14 cuidadores familiares de pessoas com doença renal crônica; a partir disso, foi possível verificar as dificuldades dos participantes e, assim, rever os itens. Conclusões: finalizado o processo de tradução e adaptação, obtém-se a versão brasileira do instrumento intitulada de “Escala para Medir a Habilidade de Cuidado de Cuidadores Familiares de Pessoas com Doença Crônica”.To reference this article / Para citar este artículo / Para citar este artigoDamasceno VAM, Zazzetta MS, Orlandi FS. Adapting the Scale to Measure the Care Ability of Family Caregivers of People with Chronic Diseases in Brazil. Aquichan 2019;19(4):e1948. DOI: https://doi.org/10.5294/aqui.2019.19.4.8Recibido: 17/02/2019Aceptado: 01/09/2019Online: 05/12/2019* Este trabalho teve apoio financeiro da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Capes) em forma de bolsa de estudos, concedido à primeira autora, e do Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brasil

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

Brazilian Flora 2020: Leveraging the power of a collaborative scientific network

International audienceThe shortage of reliable primary taxonomic data limits the description of biological taxa and the understanding of biodiversity patterns and processes, complicating biogeographical, ecological, and evolutionary studies. This deficit creates a significant taxonomic impediment to biodiversity research and conservation planning. The taxonomic impediment and the biodiversity crisis are widely recognized, highlighting the urgent need for reliable taxonomic data. Over the past decade, numerous countries worldwide have devoted considerable effort to Target 1 of the Global Strategy for Plant Conservation (GSPC), which called for the preparation of a working list of all known plant species by 2010 and an online world Flora by 2020. Brazil is a megadiverse country, home to more of the world's known plant species than any other country. Despite that, Flora Brasiliensis, concluded in 1906, was the last comprehensive treatment of the Brazilian flora. The lack of accurate estimates of the number of species of algae, fungi, and plants occurring in Brazil contributes to the prevailing taxonomic impediment and delays progress towards the GSPC targets. Over the past 12 years, a legion of taxonomists motivated to meet Target 1 of the GSPC, worked together to gather and integrate knowledge on the algal, plant, and fungal diversity of Brazil. Overall, a team of about 980 taxonomists joined efforts in a highly collaborative project that used cybertaxonomy to prepare an updated Flora of Brazil, showing the power of scientific collaboration to reach ambitious goals. This paper presents an overview of the Brazilian Flora 2020 and provides taxonomic and spatial updates on the algae, fungi, and plants found in one of the world's most biodiverse countries. We further identify collection gaps and summarize future goals that extend beyond 2020. Our results show that Brazil is home to 46,975 native species of algae, fungi, and plants, of which 19,669 are endemic to the country. The data compiled to date suggests that the Atlantic Rainforest might be the most diverse Brazilian domain for all plant groups except gymnosperms, which are most diverse in the Amazon. However, scientific knowledge of Brazilian diversity is still unequally distributed, with the Atlantic Rainforest and the Cerrado being the most intensively sampled and studied biomes in the country. In times of “scientific reductionism”, with botanical and mycological sciences suffering pervasive depreciation in recent decades, the first online Flora of Brazil 2020 significantly enhanced the quality and quantity of taxonomic data available for algae, fungi, and plants from Brazil. This project also made all the information freely available online, providing a firm foundation for future research and for the management, conservation, and sustainable use of the Brazilian funga and flora