Economic growth and greenhouse gases in Brazilian States: is the environmental Kuznets curve applicable hypothesis?

The aim of this study was to analyze the existence of the Kuznets environmental curve (EKC) hypothesis for a diverse spectrum of environmental pollutants (carbon dioxide, methane, and nitrous oxide) from the Brazilian states from 1980 to 2020. In the Kuznets hypothesis, economic growth, represented by GDP per capita, grows inflection in relation to environmental degradation. Upon reaching a certain point, the relationship becomes inversely opposite, being a positive trend of growth and a retract to environmental indicators, as in the case of greenhouse gases. The application of regression models in strict observance of Grossman and Krueger's EKC econometric model (1995) allowed a critical analysis of the Brazilian empirical model relative to pollutant emissions. The results show the corroboration of the EKC hypothesis for carbon dioxide and nitrous oxide, but not methane gas. Additionally, the discussion on the subject was extended to the debate about Brazil on the world stage. Brazil is on the world stage as a major influencer in environmental issues, so everything empirically contributes, both to academia and public managers, by presenting evidence of the relationship of economic growth aligned with sustainable development. Thus, the study provides contributions to professionals, researchers, and international readers. On the other hand, this study shows as political implications the need for improvements and reformulations of environmental policies in favor of mitigating environmental degradation.

Efeitos da solução balanceada em desfechos de curto prazo em pacientes com traumatismo craniencefálico: uma análise secundária do ensaio clínico randomizado BaSICS / Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial

RESUMO Objetivo: Descrever os efeitos do uso de soluções balanceadas nos desfechos de curto prazo de pacientes com traumatismo craniencefálico incluídos no estudo BaSICS. Métodos: Os pacientes foram randomizados para receber solução salina 0,9% ou solução balanceada durante a internação em unidade de terapia intensiva. O desfecho primário foi mortalidade em 90 dias, já os desfechos secundários foram dias de vida e sem internação em unidade de terapia intensiva aos 28 dias. O desfecho primário foi avaliado por regressão logística bayesiana. O desfecho secundário foi avaliado usando regressão beta-binomial inflada de zeros bayesiana. Resultados: Incluímos 483 pacientes (236 no braço de solução salina 0,9% e 247 no braço de solução balanceada). Foram incluídos 338 pacientes (70%) com pontuação na escala de coma de Glasgow ≤ 12. A probabilidade geral de que soluções balanceadas estivessem associadas a maior mortalidade em 90 dias foi de 0,98 (RC de 1,48; ICr95% 1,04 - 2,09). Esse aumento de mortalidade foi particularmente perceptível em pacientes com pontuação na escala de coma de Glasgow abaixo de 6 no momento da inclusão (probabilidade de dano de 0,99). Soluções balanceadas foram associadas a -1,64 dia de vida e sem internação em unidade de terapia intensiva aos 28 dias (ICr95% -3,32 - 0,00) com probabilidade de dano de 0,97. Conclusão: Houve alta probabilidade de que soluções balanceadas estivessem associadas a alta mortalidade em 90 dias, menos dias de vida e sem internação em unidade de terapia intensiva aos 28 dias. ClinicalTrials.gov:NCT02875873

ABSTRACT Objective: To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial. Methods: Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression. Results: We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 - 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 - 0.00) with a probability of harm of 0.97. Conclusion: There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days. ClinicalTrials.gov:NCT02875873

Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS).

PURPOSE: To reanalyze the results of the Balanced Solutions in Intensive Care Study (BaSICS) through hierarchical endpoint analysis with win ratio. METHODS: All patients with full data in BaSICS trial were elected for the analysis. BaSICS compared balanced solutions (Plasma Lye 148) versus 0.9% saline in critically ill patients requiring fluid challenge. The win ratio was defined as a hierarchical endpoint of 90-day mortality, recepit of kidney replacement therapy, hospital length-of-stay (LOS), and intensive care unit (ICU) LOS. Both unstratified and stratified (by admission type: planned admission, unplanned admission with sepsis, and unplanned admission without sepsis) approaches were used. A subgroup analysis was performed in patients with traumatic brain injury. RESULTS: A total of 10,490 patients were included in the analysis, resulting in 27,587,566 unique combinations for unstratified WR. Unstratified Win ratio was 1.02 (95% confidence interval 0.97; 1.07), which was similar to stratified WR. No stratum in the stratified analysis resulted in significant results. Subgroup analysis confirmed the possible harm of balanced solutions in traumatic brain injury patients (WR 0.80; 95% confidence interval 0.64; 0.99). CONCLUSION: In this reanalysis of BaSICS, a win ratio analysis largely replicated the results of the main trial, yielding neutral results except for the subgroup of patients with traumatic brain injury where a signal of harm was found.

Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults: A Secondary Exploratory Analysis of the BaSICS Clinical Trial.

Rationale: The effects of balanced crystalloid versus saline on clinical outcomes for ICU patients may be modified by the type of fluid that patients received for initial resuscitation and by the type of admission. Objectives: To assess whether the results of a randomized controlled trial could be affected by fluid use before enrollment and admission type. Methods: Secondary post hoc analysis of the BaSICS (Balanced Solution in Intensive Care Study) trial, which compared a balanced solution (Plasma-Lyte 148) with 0.9% saline in the ICU. Patients were categorized according to fluid use in the 24 hours before enrollment in four groups (balanced solutions only, 0.9% saline only, a mix of both, and no fluid before enrollment) and according to admission type (planned, unplanned with sepsis, and unplanned without sepsis). The association between 90-day mortality and the randomization group was assessed using a hierarchical logistic Bayesian model. Measurements and Main Results: A total of 10,520 patients were included. There was a low probability that the balanced solution was associated with improved 90-day mortality in the whole trial population (odds ratio [OR], 0.95; 89% credible interval [CrI], 0.66-10.51; probability of benefit, 0.58); however, probability of benefit was high for patients who received only balanced solutions before enrollment (regardless of admission type, OR, 0.78; 89% CrI, 0.56-1.03; probability of benefit, 0.92), mostly because of a benefit in unplanned admissions due to sepsis (OR, 0.70; 89% CrI, 0.50-0.97; probability of benefit, 0.96) and planned admissions (OR, 0.79; 89% CrI, 0.65-0.97; probability of benefit, 0.97). Conclusions: There is a high probability that balanced solution use in the ICU reduces 90-day mortality in patients who exclusively received balanced fluids before trial enrollment. Clinical trial registered with www.clinicaltrials.gov (NCT02875873).

Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial. / Efeitos da solução balanceada em desfechos de curto prazo em pacientes com traumatismo craniencefálico: uma análise secundária do ensaio clínico randomizado BaSICS.

OBJECTIVE: To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial. METHODS: Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression. RESULTS: We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 - 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 - 0.00) with a probability of harm of 0.97. CONCLUSION: There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days.ClinicalTrials.gov: NCT02875873.

OBJETIVO: Descrever os efeitos do uso de soluções balanceadas nos desfechos de curto prazo de pacientes com traumatismo craniencefálico incluídos no estudo BaSICS. MÉTODOS: Os pacientes foram randomizados para receber solução salina 0,9% ou solução balanceada durante a internação em unidade de terapia intensiva. O desfecho primário foi mortalidade em 90 dias, já os desfechos secundários foram dias de vida e sem internação em unidade de terapia intensiva aos 28 dias. O desfecho primário foi avaliado por regressão logística bayesiana. O desfecho secundário foi avaliado usando regressão beta-binomial inflada de zeros bayesiana. RESULTADOS: Incluímos 483 pacientes (236 no braço de solução salina 0,9% e 247 no braço de solução balanceada). Foram incluídos 338 pacientes (70%) com pontuação na escala de coma de Glasgow ≤ 12. A probabilidade geral de que soluções balanceadas estivessem associadas a maior mortalidade em 90 dias foi de 0,98 (RC de 1,48; ICr95% 1,04 - 2,09). Esse aumento de mortalidade foi particularmente perceptível em pacientes com pontuação na escala de coma de Glasgow abaixo de 6 no momento da inclusão (probabilidade de dano de 0,99). Soluções balanceadas foram associadas a -1,64 dia de vida e sem internação em unidade de terapia intensiva aos 28 dias (ICr95% -3,32 - 0,00) com probabilidade de dano de 0,97. CONCLUSÃO: Houve alta probabilidade de que soluções balanceadas estivessem associadas a alta mortalidade em 90 dias, menos dias de vida e sem internação em unidade de terapia intensiva aos 28 dias.ClinicalTrials.gov: NCT02875873.

Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial.

Importance: Slower intravenous fluid infusion rates could reduce the formation of tissue edema and organ dysfunction in critically ill patients; however, there are no data to support different infusion rates during fluid challenges for important outcomes such as mortality. Objective: To determine the effect of a slower infusion rate vs control infusion rate on 90-day survival in patients in the intensive care unit (ICU). Design, Setting, and Participants: Unblinded randomized factorial clinical trial in 75 ICUs in Brazil, involving 11 052 patients requiring at least 1 fluid challenge and with 1 risk factor for worse outcomes were randomized from May 29, 2017, to March 2, 2020. Follow-up was concluded on October 29, 2020. Patients were randomized to 2 different infusion rates (reported in this article) and 2 different fluid types (balanced fluids or saline, reported separately). Interventions: Patients were randomized to receive fluid challenges at 2 different infusion rates; 5538 to the slower rate (333 mL/h) and 5514 to the control group (999 mL/h). Patients were also randomized to receive balanced solution or 0.9% saline using a factorial design. Main Outcomes and Measures: The primary end point was 90-day survival. Results: Of all randomized patients, 10 520 (95.2%) were analyzed (mean age, 61.1 years [SD, 17.0 years]; 44.2% were women) after excluding duplicates and consent withdrawals. Patients assigned to the slower rate received a mean of 1162 mL on the first day vs 1252 mL for the control group. By day 90, 1406 of 5276 patients (26.6%) in the slower rate group had died vs 1414 of 5244 (27.0%) in the control group (adjusted hazard ratio, 1.03; 95% CI, 0.96-1.11; P = .46). There was no significant interaction between fluid type and infusion rate (P = .98). Conclusions and Relevance: Among patients in the intensive care unit requiring fluid challenges, infusing at a slower rate compared with a faster rate did not reduce 90-day mortality. These findings do not support the use of a slower infusion rate. Trial Registration: ClinicalTrials.gov Identifier: NCT02875873.

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial.

IMPORTANCE: Intravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury. OBJECTIVE: To determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately). INTERVENTIONS: Patients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids. MAIN OUTCOMES AND MEASURES: The primary outcome was 90-day survival. RESULTS: Among 11 052 patients who were randomized, 10 520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed; P = .98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05]; P = .47). There were no unexpected treatment-related severe adverse events in either group. CONCLUSION AND RELEVANCE: Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02875873.

Tradução e adaptação transcultural do Creighton Competency Evaluation Instrument para o Brasil / Traducción y adaptación transcultural del Creighton Competency Evaluation Instrument para Brasil / Translation and cross-cultural adaptation of the Creighton Competency Evaluation Instrument for Brazil

Resumo Objetivo: Traduzir para a língua portuguesa e adaptar transculturalmente para o Brasil o Creighton Competency Evaluation Instrument. Métodos: Pesquisa metodológica que adotou o referencial de Beaton para o processo de tradução e adaptação transcultural, que ocorreu em seis etapas: tradução, síntese das traduções, retrotradução, submissão ao comitê de especialistas, pré-teste e parecer do autor original. Participaram dois tradutores, dois retrotradutores e oito membros no comitê de especialistas. O pré-teste foi realizado com 32 participantes. Resultados: Após ajustes linguísticos, a versão final obteve concordância de 100% pelo Índice de Validade de Conteúdo. A confiabilidade (Alfa de Cronbach) foi de 0,897, considerado um ótimo resultado. O instrumento foi classificado como de fácil utilização por 84,4% dos experts. Conclusão: A tradução e a adaptação transcultural disponibiliza para a comunidade acadêmica brasileira um instrumento objetivo e prático, com possibilidade de feedback imediato aos estudantes nas avaliações durante a atividade clínica simulada.

Resumen Objetivo: Traducir al idioma portugués y adaptar transculturalmente para Brasil el Creighton Competency Evaluation Instrument. Métodos: Investigación metodológica que adoptó el marco referencial de Beaton para el proceso de traducción y adaptación transcultural, realizada en seis etapas: traducción, síntesis de las traducciones, retrotraducción, presentación al comité de especialistas, prueba piloto y opinión del autor original. Participaron dos traductores, dos retrotraductores y ocho miembros del comité de especialistas. La prueba piloto fue realizada con 32 participantes. Resultados: Después de los ajustes lingüísticos, la versión final obtuvo una concordancia del 100 % mediante el Índice de Validez de Contenido. La fiabilidad (Alfa de Cronbach) fue de 0,897, considerado un excelente resultado. El instrumento fue clasificado como fácil de utilizar por el 84,4 % de los especialistas. Conclusión: La traducción y la adaptación transcultural pone a disposición de la comunidad académica brasileña un instrumento objetivo y práctico, con posibilidad de feedback inmediato a los estudiantes en las evaluaciones durante la actividad clínica simulada.

Abstract Objective: To translate and adapt the Creighton Competency Evaluation Instrument for Brazil. Methods: A methodological research that adopted Beaton's framework for the process of translation and cross-cultural adaptation, which took place in six stages: translation, synthesis of translations, back-translation, submission to the expert committee, pre-test and opinion of the original author. Two translators, two back-translators and eight members of the expert committee participated. Pre-test was carried out with 32 participants. Results: After linguistic adjustments, the final version obtained 100% agreement by the Content Validity Index. Reliability (Cronbach's alpha) was 0.897, which is considered an excellent result. The instrument was classified as easy to use by 84.4% of experts. Conclusion: Translation and cross-cultural adaptation provide the Brazilian academic community with an objective and practical tool, with the possibility of immediate feedback to students in assessments during simulated clinical activities.

Contribuições da simulação clínica versus prática convencional em laboratório de enfermagem na primeira experiência clínica / Contribuciones de la simulación clínica versus la práctica convencional en laboratorio de enfermería en la primera experiencia clínica / Contributions of clinical simulation versus conventional practice in a nursing laboratory in the first clinical experience

Resumo Objetivo Comparar a percepção de estudantes de enfermagem e as contribuições do ensino com simulação clínica ou aula prática convencional em laboratório de habilidades, na primeira experiência clínica hospitalar. Método Pesquisa descritiva, qualitativa, envolvendo estudantes de graduação em enfermagem de uma universidade pública do Brasil, submetidos à simulação clínica de alta fidelidade ou aula prática convencional, ocorrida entre 2015 e 2016. Para avaliação dos dados, utilizaram-se a nuvem de palavras e a análise de similitude do software IRAMUTEQ®. Resultados Participaram 54 estudantes, sendo 27 em cada grupo. As palavras mais evocadas pelo grupo simulação foram: "paciente real, não, mais e simulador", relacionadas à capacidade de reflexão quanto ao seu conhecimento e preparo. As mais evocadas no grupo prática convencional foram: "mais, não, muito e sentir", relacionadas com a percepção de que a aula convencional ajuda na aquisição de habilidades, contudo, é necessária maior frequência. Conclusão As duas estratégias contribuíram positivamente para a primeira experiência clínica hospitalar. Porém, a simulação proporcionou uma visão crítico-reflexiva sobre as competências, deficiências e maior autoconfiança em relação à prática convencional. Este estudo fortalece as evidências dos benefícios proporcionados pelo ensino baseado em simulação, e a importância de instituições de ensino fazerem uso adequado dessa estratégia.

Resumen Objetivo Comparar la percepción de los estudiantes de enfermería y las contribuciones docentes con simulación clínica o clase práctica convencional en un laboratorio de habilidades, en la primera experiencia clínica hospitalaria. Métodos Investigación descriptiva y cualitativa con estudiantes universitarios de enfermería en una universidad pública de Brasil, sometidos a simulación clínica de alta fidelidad o clase práctica convencional, entre 2015 y 2016. Para el análisis de los datos se utilizo, una nube de palabras y el análisis de la similitud por el software IRAMUTEQ. Resultados Participaron 54 estudiantes, 27 en cada grupo. Las palabras mas evocadas por el grupo de simulación fueron: "paciente real, no, más y simulador" relacionadas con la capacidad de reflexionar sobre su conocimiento y preparación. Los más mencionados en el grupo práctica convencional fueron: "más, no, mucho y sentir", relacionadas con la percepción de que la clase convencional ayuda en la adquisición de habilidades, sin embargo se necesita más frecuencia. Conclusion Ambas estrategias contribuyeron positivamente para la primera experiencia clínica hospitalaria. Sin embargo, la simulación proporcionó una visión crítica reflexiva de las habilidades, deficiencias y una mayor autoconfianza en comparación con la práctica convencional. Este estudio fortalece la evidencia de los beneficios proporcionados por la enseñanza basada en simulación y la importancia de que las instituciones educativas hagan uso adecuado de esta estrategia.

Abstract Objective to compare the perception of nursing students and the contributions of teaching with clinical simulation or conventional practical classroom skills in the first clinical hospital experience. Method a descriptive, qualitative research involving undergraduate nursing students from a public university in Brazil, submitted to a high fidelity clinical simulation or conventional practical class, which took place between 2015 and 2016. For data evaluation, a word cloud and similarity analysis of the IRAMUTEQ® software were used. Results Altogether 54 students participated, 27 of them in each group. The words most evoked by the simulation group were: "real patient, no, more and simulator", related to the capacity of reflection regarding their knowledge and preparation. The most evoked by the conventional practice group were: "more, no, much and feel", related with the perception that the conventional class helps in the acquisition of skills, however, more frequency is needed. Conclusion Both strategies contributed positively to the first clinical hospital experience. However, the simulation provided a critical-reflexive view of skills, deficiencies and greater self-confidence in relation to conventional practice. This study strengthens the evidence of the benefits provided by simulation-based teaching, and the importance of teaching institutions making appropriate use of this strategy.

Synthesis, characterization and photothermal analysis of nanostructured hydrides of Pd and PdCeO2.

Hyperthermia was shown to be an important co-adjuvant therapy to conventional cancer treatments. Nanoparticles can be used in the hyperthermia therapy to improve the localized absorption of energy imposed by external sources, in order to kill tumor cells solely by the effect of heat and with minimum thermal damage to surrounding healthy cells. Nanoparticles can also serve as carriers of drugs that specifically act on the tumor when heated, including hydrogen that can be desorbed to locally promote an antioxidant effect and reduce the viability of cancer cells. In this context, palladium hydride nanoparticles emerge as promising materials for the hyperthermia therapy. In this study, palladium nanocubes (PdNC) and PdCeO2 nanoparticles were synthesized. Nanofluids produced with these nanomaterials were hydrogenated and then tested to examine their photothermal effects. Nanofluids made of PdHx nanoparticles presented significant temperature increases of more than 30 °C under 3 min of diode-laser irradiation. On the other hand, nanofluids with PdCeO2H nanoparticles presented temperature increases around 11 °C under the same experimental conditions. The behavior observed with the PdCeO2H nanofluids can be attributed to the effect of H+ in reducing Ce+4 to Ce+3.

Effect of in vitro gastrointestinal digestion on the mineral content, phenolic compounds, and antioxidant capacity of commercial pulps of purple and white açaí (Euterpe oleracea Mart.).

Mineral content, total phenolic compounds (TPC), and antioxidant capacity were determined in three samples of purple-açaí (coarse-PAC, medium-PAM, and fine-PAF), and one of white-açaí (coarse-WAC) and their respective bioaccessible fractions. TPC content differed in all samples, with PAC (583.79 mgAGE/100 g) having the highest content; however, PAM showed higher bioaccessibility (32.27%). PAC presented higher antioxidant capacity in the FRAP tests (74.34 µM FeSO4/g) and ABTS (55.05 µM Trolox/g). However, no differences were found in DPPH between PAC (1986.66 EC50) and PAM (2408.88 EC50) samples. Antioxidant capacity was decreased in all samples after digestion. Potassium was in the highest proportion (7121.90 mg/100 g-PAC), followed by Ca (349.92 mg/100 g-PAM), and Mg (169.41 mg/100 g-PAM), in all the samples. However, Ca presented the highest bioaccessible fraction, followed by Mg and Mn, with the highest percentages observed in WAC samples (90.30, 74.30, and 64.52%, respectively).

Validação psicométrica do instrumento Creighton para avaliação de competências clínicas em simulação / Validación psicométrica del instrumento Creighton para evaluar competencias clínicas en simulacro / Psychometric validation of the Creighton Competency Evaluation Instrument in simulation

Resumo Objetivo: Validar construto e avaliar a confiabilidade do Instrumento Creighton para Avaliação de Competências Clínicas, versão português, Brasil. Métodos: Estudo metodológico, realizado com 30 docentes/enfermeiros que utilizavam a metodologia de simulação. Foram elaborados dois cenários com temas iguais e atuações divergentes das estudantes com o objetivo de testar a capacidade do instrumento de diferenciá-los. Os cenários foram gravados e disponibilizados para os especialistas por um website que viabilizou a coleta. Para a validação de construto, utilizou-se as técnicas de experimentação e da correlação phi. Para a confiabilidade, analisou-se a equivalência, com coeficiente Fleiss Kappa, e a consistência interna, com coeficiente Kuder-Richardson (KR20). Resultados: Ao analisar a validade, 20 dos 23 itens apresentaram resultados significativos. Na análise, os domínios apresentaram correlações, classificadas de baixa a alta. Quando comparados os cenários, as correlações foram baixas, muito baixas ou negativas. Quanto à confiabilidade, o coeficiente Fleiss Kappa encontrado foi razoável (0,282) para o cenário 1 e moderado para o cenário 2 (0,408). A consistência interna medida com o KR20 foi de 0,717 para o cenário 1 e 0,805 para o cenário 2, classificadas como moderada e alta. Conclusão: O Instrumento Creighton para Avaliação de Competências Clínicas versão português, Brasil, foi considerado válido e confiável para uso em todo o território nacional.

Resumen Objetivo: Validar el constructo y analizar la confiabilidad del instrumento Creighton para Evaluación de Competencias Clínicas, versión en portugués, Brasil. Métodos: Estudio metodológico, realizado con 30 docentes/enfermeros que utilizaban la metodología de simulacro. Se elaboraron dos situaciones con temas iguales y actuaciones divergentes de las estudiantes, con el objetivo de probar la capacidad del instrumento de diferenciarlas. Las situaciones fueron grabadas y se pusieron a disposición de los especialistas mediante un sitio web que viabilizó la recolección. Para la validación del constructo se utilizaron las técnicas de experimentación y del coeficiente de correlación phi. Para la confiabilidad, se analizó la equivalencia con coeficiente Fleiss Kappa y la consistencia interna con coeficiente Kuder-Richardson (KR20). Resultados: Al analizar la validez, 20 de los 23 ítems presentaron resultados significativos. En el análisis, los dominios presentaron correlaciones, clasificadas de baja a alta. Al comparar las situaciones, las correlaciones fueron bajas, muy bajas o negativas. Respecto a la confiabilidad, el coeficiente Fleiss Kappa encontrado fue razonable (0,282) en la situación 1 y moderado en la situación 2 (0,408). La consistencia interna medida con el KR20 fue de 0,717 en la situación 1 y 0,805 en la situación 2, clasificada como moderada y alta. Conclusión: El instrumento Creighton para Evaluación de Competencias Clínicas, versión en portugués, Brasil, fue considerado válido y confiable para su uso en todo el territorio nacional.

Abstract Objective: To validate and assess the Creighton Competency Evaluation Instrument reliability, Brazilian Portuguese version. Methods: This is a methodological study conducted with 30 professors/nurses who used the simulation methodology. Two scenarios were elaborated with equal themes and divergent performances of students in order to test the ability of the instrument to differentiate them. The scenarios were recorded and made available to the experts by a website that enabled the collection. For construct validation, the experimentation and phi correlation techniques were used. For reliability, equivalence with the Fleiss Kappa coefficient and internal consistency with Kuder-Richardson coefficient (KR20) were analyzed. Results: When analyzing validity, 20 of the 23 items showed significant results. In analysis, the domains presented correlations, classified from slight to substantial. When the scenarios were compared, the correlations were low, poor or negative. Regarding reliability, the Fleiss Kappa coefficient found was fair (0.282) for scenario 1 and moderate for scenario 2 (0.408). The internal consistency measured with KR20 was 0.717 for scenario 1 and 0.805 for scenario 2, classified as moderate and substantial. Conclusion: The Creighton Competency Evaluation Instrument, Brazilian Portuguese version, was considered valid and reliable for use nationally.

Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial.

Importance: The effects of intensive care unit (ICU) visiting hours remain uncertain. Objective: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium. Design, Setting and Participants: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018. Interventions: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation. Main Outcomes and Measures: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory). Results: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation. Conclusions and Relevance: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium. Trial Registration: ClinicalTrials.gov Identifier: NCT02932358.

Uso do Cilostazol na adolescência para pacientes com bradicardia relacionada à vagotonia: descrição de uma série de casos / Cilostazol use in adolescence for bradycardia patients related to vagotonia: description of a case series

INTRODUÇÃO: As bradicardias em adolescentes podem ser geradas por doenças próprias no tecido de condução ou por influência externa (tônus vagal por exemplo). A vagotonia sintomática leva profissionais de saúde a precocemente indicar o implante de dispositivos de estimulação cardíaca artificial. Entretanto a exiguidade de próteses em nosso meio, relacionado à grande demanda e o caráter transitório da vagotonia na população hebiatrica leva ao receio da superindicação. Os inibidores de fosfodieterase como o cilostazol podem auxiliar na disfunção transitória por aumentar a condução dos canais de sódio na fase de despolarização espontânea (canais funny) das células automáticas. OBJETIVO: Descrever 4 casos de adolescentes com bradicardia de causa extrínseca em avaliação para implante de marca-passo definitivo submetidos à terapia oral com cilostazol. RESULTADOS: Foram avaliados 4 adolescentes (12,15,16 e 18 anos), sendo 3 masculinos, com bradicardia de origem externa (responsivas à ergometria ou atropina) foram submetidos à terapia medicamentosa com cilostazol após descartar-se arritmias ventriculares originadas por atividade deflagrada. Uma paciente possuia cardiopatia congênita (cavopulmonar total - ventrículo único tipo esquerdo sem isomerismo atrial). Os demais possuíam coração estruturalmente normal. A função ventricular estava preservada em todos. Todos apresentavam pausas sinusais superiores a 2,5s e ou bloqueios atrioventriculares paroxísticos. A dose inicial de 50 mg/dia foi introduzida com progressão da dose até 100 mg a cada 12 horas como objetivo terapêutico. Apenas a portadora de cardiopatia congênita foi mantida com a dose inicial devido boa resposta do Holter e na saturação. Em todos houve redução de mais de 90% das pausas com elevação da FC média sem exacerbação dos períodos de taquicardia ao Holter (periodicidade quinzenal). A variabilidade da frequência cardíaca no domínio do tempo e da frequência após o uso do fármaco apresentou melhora da relação LF/HF em todos os casos e redução do pNN50 em 75% dos pacientes. Não houve alteração hepática ou renal durante o uso de medicação. Todos estiveram assintomáticos durante o seguimento de 3 meses a 4 anos. CONCLUSÃO: 1) O uso de cilostazol diminui o desbalanço simpático parassimpático reduzindo episódios de pausas e bradicardias; 2) O tratamento do desequilíbrio autonômico com cilostazol em adolescentes púberes sintomáticos pode evitar o implante de dispositivo anti bradicardia. (AU)

Effect of a Multifaceted Quality Improvement Intervention on the Prescription of Evidence-Based Treatment in Patients at High Cardiovascular Risk in Brazil: The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial.

Importance: Studies have found that patients at high cardiovascular risk often fail to receive evidence-based therapies in community practice. Objective: To evaluate whether a multifaceted quality improvement intervention can improve the prescription of evidence-based therapies. Design, Setting, and Participants: In this 2-arm cluster randomized clinical trial, patients with established atherothrombotic disease from 40 public and private outpatient clinics (clusters) in Brazil were studied. Patients were recruited from August 2016 to August 2017, with follow-up to August 2018. Data were analyzed in September 2018. Interventions: Case management, audit and feedback reports, and distribution of educational materials (to health care professionals and patients) vs routine practice. Main Outcomes and Measures: The primary end point was prescription of evidence-based therapies (ie, statins, antiplatelet therapy, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) using the all-or-none approach at 12 months after the intervention period in patients without contraindications. Results: Of the 1619 included patients, 1029 (63.6%) were male, 1327 (82.0%) had coronary artery disease (843 [52.1%] with prior acute myocardial infarction), 355 (21.9%) had prior ischemic stroke or transient ischemic attack, and 197 (12.2%) had peripheral vascular disease, and the mean (SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary care units, and 26 (65%) were teaching institutions. Among eligible patients, those in intervention clusters were more likely to receive a prescription of evidence-based therapies than those in control clusters (73.5% [515 of 701] vs 58.7% [493 of 840]; odds ratio, 2.30; 95% CI, 1.14-4.65). There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes). Rates of education for smoking cessation were higher among current smokers in the intervention group than in the control group (51.9% [364 of 701] vs 18.2% [153 of 840]; odds ratio, 11.24; 95% CI, 2.20-57.43). The rate of cardiovascular mortality, acute myocardial infarction, and stroke was 2.6% for patients from intervention clusters and 3.4% for those in the control group (hazard ratio, 0.76; 95% CI, 0.43-1.34). Conclusions and Relevance: Among Brazilian patients at high cardiovascular risk, a quality improvement intervention resulted in improved prescription of evidence-based therapies. Trial Registration: ClinicalTrials.gov identifier: NCT02851732.

Computational fluid dynamic analysis of physical forces playing a role in brain organoid cultures in two different multiplex platforms.

BACKGROUND: Organoid cultivation in suspension culture requires agitation at low shear stress to allow for nutrient diffusion, which preserves tissue structure. Multiplex systems for organoid cultivation have been proposed, but whether they meet similar shear stress parameters as the regularly used spinner flask and its correlation with the successful generation of brain organoids has not been determined. RESULTS: Here we used computational fluid dynamics (CFD) to simulate two multiplex culture conditions: steering plates on an orbital shaker and the use of a previously described bioreactor. The bioreactor had low speed and high shear stress regions that may affect cell aggregate growth, depending on volume, whereas the computed variables of the steering plates were closer to those of the spinning flask. CONCLUSION: Our protocol improves the initial steps of the standard brain organoid formation, and the produced organoids displayed regionalized brain structures, including retinal pigmented cells. Overall, we conclude that suspension culture on orbital steering plates is a cost-effective practical alternative to previously described platforms for the cultivation of brain organoids for research and multiplex testing.

Tradução e adaptação transcultural do Creighton Competency Evaluation Instrument para a língua portuguesa (Brasil) / Translation and cross-cultural adaptation of the Creighton Competency Evaluation Instrument into Portuguese (Brazil)

Resumo: As Diretrizes Curriculares Nacionais propõem que a formação de futuros enfermeiros contemple a aquisição de competências gerenciais, de comunicação, liderança, tomada de decisão, ensino, pesquisa e atenção à saúde. Para avaliar a aquisição de competências são necessários instrumentos confiáveis que possam mensurar esse aprendizado. Há ainda um déficit de instrumentos confiáveis para a prática clínica simulada que permitam avaliar a aquisição de competências clínicas, o que dificulta a percepção do desempenho e evolução dos estudantes. A universidade de Creighton, nos Estados Unidos, propôs um instrumento para avaliar competências denominado de Creighton Competency Evaluation Instrument (CCEI) que está dividido em quatro categorias: avaliação, comunicação, julgamento clínico e segurança do paciente, em cada categoria existem itens para avaliar se o estudante demonstra ou não competência, totalizando 23 itens. Esse instrumento vem sendo amplamente utilizado nas pesquisas norte-americanas envolvendo a simulação clínica e demonstrou ótimo resultado de confiabilidade medido pelo Alfa de Cronbach >0,90. Este estudo metodológico teve como objetivo traduzir para a língua portuguesa e adaptar transculturalmente no Brasil o Creighton Competency Evaluation Instrument (CCEI) para avaliação de competências em cenário de simulação clínica. A pesquisa foi aprovada pelo Comitê de Ética da Universidade Federal do Paraná sob o parecer n0 2.387.308. O processo de tradução e adaptação transcultural ocorreu em seis etapas: tradução do instrumento por dois tradutores independentes nativos da língua alvo. Síntese das traduções. Retrotradução por dois tradutores nativos da língua original. Reunião com o comitê de especialistas. Préteste realizado por 32 experts em simulação clínica de varias regiões do país, o que conferiu à versão final uma linguagem usual aos membros da comunidade acadêmica de língua portuguesa do Brasil. Sexta etapa apresentação e parecer do autor original. A versão traduzida e adaptada demonstrou bons resultados estatísticos. O índice de Validade de Conteúdo (IVC) para a escala geral foi calculado pela média do índice de Validade de Conteúdo dos itens (IVC-I) e atingiu 100% de concordância. A confiabilidade calculada pelo Alfa de Cronbach foi de 0,897, considerado um ótimo resultado. O instrumento foi considerado de fácil utilização por 84,4% dos experts. A tradução e adaptação transcultural realizada nesta pesquisa disponibiliza para a comunidade acadêmica um instrumento objetivo e prático, com possibilidade de feedback imediato ao estudante nas avaliações em cenário clínico simulado. Para garantir consistência à avaliação é recomendado o preenchimento da planilha de discussão, onde serão definidos os comportamentos mínimos esperados para determinar se o estudante atingiu o objetivo da avaliação.

Abstract: The National Curricular Directives propose that training of future nurses should contemplate the development of competencies as management, communication, leadership, decision making, teaching, research and health care. However, there is a shortage of reliable evaluation instruments of clinical skills for the simulated clinical practice that makes it difficult to perceive students' performance and evolution. The University of Creighton, in the United States, has performed a tool for assessing competencies called, Creighton Competency Evaluation Instrument (CCEI), which is divided into four categories: evaluation, communication, clinical judgment and patient safety. In total, there are 23 items to assess if the student demonstrates or not competencies. This instrument has been widely used in North American research involving clinical simulation and demonstrated an excellent reliability result measured by Cronbach's Alpha >0.90. Therefore, the aim of this methodological study was to translate the Creighton Competency Evaluation Instrument (CCEI) to Brazilian Portuguese language and to transculturally adapt it in Brazil to evaluate competences in a clinical simulation scenario. The process of transcultural translation and adaptation was carried out in six stages: translation of the instrument by two independent translators native to the target language, synthesis of translations, backtranslation by two native translators of the original language, meeting with the experts committee's assessments, pre-test performed by 32 experts in clinical simulation of several regions of the country, which gave the final version a language usual to the members of the Portuguese-speaking academic community of Brazil, and the final stage presentation and opinion of the original author. This study was previously approved by the Ethics Committee of the Federal University of Paraná under authorization No. 2.387.308. The translated and adapted version showed good statistical results. For the scale, the Content Validity Index (CVI) was calculated by the average of Content Validity Index of Items (CVI-I) and reached 100% agreement. The reliability calculated by Cronbach's alpha was 0.897, considered an excellent result. Also, it was considered easy to use by 84.4% of the experts. The transcultural translation and adaptation carried out in this research provides the academic community an objective and practical instrument, with the possibility of immediate feedback to the student in simulated clinical scenario evaluations. To ensure consistency of assessment, it is recommended to fill out the discussion spreadsheet, where the minimum expected behaviors will be defined to determine if the student has reached the evaluation goal.

Rationale and design for a cluster randomized quality improvement trial to increase the uptake of evidence based therapies for patients at high cardiovascular risk: The bridge cardiovascular prevention trial

BACKGROUND: Translating evidence into clinical practice in the management of high cardiovascular risk patients is challenging. Few quality improvement interventions have rigorously evaluated their impact on both patient care and clinical outcomes. OBJECTIVES: The main objectives are to evaluate the impact of a multifaceted educational intervention on adherence to local guidelines for the prescription of statins, antiplatelets and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers for high cardiovascular risk patients, as well as on the incidence of major cardiovascular events. DESIGN: We designed a pragmatic two arm cluster randomized trial involving 40 clusters. Clusters are randomized to receive a multifaceted quality improvement intervention or to routine practice (control). The multifaceted intervention includes: reminders, care algorithms, training of a case manager, audit and feedback reports, and distribution of educational materials to health care providers. The primary endpoint is the adherence to combined evidence-based therapies (statins, antiplatelet therapy and angiotensin converting enzyme inhibitors or angiotensin receptor blockers) at 12 months after the intervention period in patients without contra-indications for these medications. All analyses follow the intention-to-treat principle and take the cluster design into account using linear mixed logistic regression modeling. SUMMARY: If proven effective, this multifaceted intervention would have wide utility as a means of promoting optimal usage of evidence-based interventions for the management of high cardiovascular risk patients. (AU)

Rationale and design for a cluster randomized quality-improvement trial to increase the uptake of evidence-based therapies for patients at high cardiovascular risk: The BRIDGE-Cardiovascular Prevention trial.

BACKGROUND: Translating evidence into clinical practice in the management of high cardiovascular risk patients is challenging. Few quality improvement interventions have rigorously evaluated their impact on both patient care and clinical outcomes. OBJECTIVES: The main objectives are to evaluate the impact of a multifaceted educational intervention on adherence to local guidelines for the prescription of statins, antiplatelets and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers for high cardiovascular risk patients, as well as on the incidence of major cardiovascular events. DESIGN: We designed a pragmatic two arm cluster randomized trial involving 40 clusters. Clusters are randomized to receive a multifaceted quality improvement intervention or to routine practice (control). The multifaceted intervention includes: reminders, care algorithms, training of a case manager, audit and feedback reports, and distribution of educational materials to health care providers. The primary endpoint is the adherence to combined evidence-based therapies (statins, antiplatelet therapy and angiotensin converting enzyme inhibitors or angiotensin receptor blockers) at 12 months after the intervention period in patients without contra-indications for these medications. All analyses follow the intention-to-treat principle and take the cluster design into account using linear mixed logistic regression modeling. SUMMARY: If proven effective, this multifaceted intervention would have wide utility as a means of promoting optimal usage of evidence-based interventions for the management of high cardiovascular risk patients.

Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study).

BACKGROUND: Most adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals. METHODS/DESIGN: The ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data. DISCUSSION: This a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02932358 . Registered on 11 October 2016.