Attending (or not) after-school programs during the COVID-19 pandemic: What happens to children's social skills and behavior problems?

The demand for After-School Programs (ASP) has increased in the last decades, mainly related to the reduced availability of the family to take care of children in the after-school period. This study aimed to compare two groups of children who attend (ASP group) or not ASP (comparison group), from the first and second grade, regarding their social skills and behavior problems. Teachers assessed 120 children (half by group) across three times (one before and two during the COVID-19 pandemic). A pattern of ASP attendance was determined, in order to understand whether ASP attendance influences social skills and behavior problems. The results indicated that children who attended ASP showed higher levels of self-control and assertion skills. Higher levels of hyperactivity were reported by teachers for both groups when children came back to school after the first COVID-19 lockdown. Parents enrolled their children in ASP mostly for safety; and ASP attendance had a positive effect on social skills and negative on behavior problems. The implications of attending ASP associated to a more positive child development are discussed.

Statistical process control of manufacturing tablets for antiretroviral therapy

Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

Dapagliflozin and Kidney Outcomes in Hospitalized Patients with COVID-19 Infection: An Analysis of the DARE-19 Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Patients who were hospitalized with coronavirus disease 2019 (COVID-19) infection are at high risk of AKI and KRT, especially in the presence of CKD. The Dapagliflozin in Respiratory Failure in Patients with COVID-19 (DARE-19) trial showed that in patients hospitalized with COVID-19, treatment with dapagliflozin versus placebo resulted in numerically fewer participants who experienced organ failure or death, although these differences were not statistically significant. We performed a secondary analysis of the DARE-19 trial to determine the efficacy and safety of dapagliflozin on kidney outcomes in the overall population and in prespecified subgroups of participants defined by baseline eGFR. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The DARE-19 trial randomized 1250 patients who were hospitalized (231 [18%] had eGFR <60 ml/min per 1.73 m2) with COVID-19 and cardiometabolic risk factors to dapagliflozin or placebo. Dual primary outcomes (time to new or worsened organ dysfunction or death, and a hierarchical composite end point of recovery [change in clinical status by day 30]), and the key secondary kidney outcome (composite of AKI, KRT, or death), and safety were assessed in participants with baseline eGFR <60 and ≥60 ml/min per 1.73 m2. RESULTS: The effect of dapagliflozin versus placebo on the primary prevention outcome (hazard ratio, 0.80; 95% confidence interval, 0.58 to 1.10), primary recovery outcome (win ratio, 1.09; 95% confidence interval, 0.97 to 1.22), and the composite kidney outcome (hazard ratio, 0.74; 95% confidence interval, 0.50 to 1.07) were consistent across eGFR subgroups (P for interaction: 0.98, 0.67, and 0.44, respectively). The effects of dapagliflozin on AKI were also similar in participants with eGFR <60 ml/min per 1.73 m2 (hazard ratio, 0.71; 95% confidence interval, 0.29 to 1.77) and ≥60 ml/min per 1.73 m2 (hazard ratio, 0.69; 95% confidence interval, 0.37 to 1.29). Dapagliflozin was well tolerated in participants with eGFR <60 and ≥60 ml/min per 1.73 m2. CONCLUSIONS: The effects of dapagliflozin on primary and secondary outcomes in hospitalized participants with COVID-19 were consistent in those with eGFR below/above 60 ml/min per 1.73 m2. Dapagliflozin was well tolerated and did not increase the risk of AKI in participants with eGFR below or above 60 ml/min per 1.73 m2.

Handmade solar dryer: an environmentally and economically viable alternative for small and medium producers.

The solar dryer can reduce production costs, energy consumption, waste (use fruits outside the quality standard for fresh consumption) and is an alternative for small and medium producers. The solar dryer can reduce costs and is an alternative for small and medium producers worldwide. The consumption of fresh and processed tomatoes is high in the world, but post-harvest losses is also and drying is an alternative to reduce these losses. The temperature maintenance and drying time corresponds 30% of the costs. The objective was evaluated the tomato physicochemical characteristics after drying in handmade solar dryer. 'Carmen' tomato fruits were bleached in water, 2.5% NaCl solution, 2.5% NaCl + 0.5% CaCl2 solution and unbleached. Tomato slices were placed in a handmade solar dryer from 7:00 to 17:00. The solar dryer prototype was wood made, comprising a collector and a drying chamber. The average cost of the camera was US$ 13.08 (1 Brazilian Real = 0.26 United States Dollar). Water loss, drying kinetics, mathematical models and physicochemical characteristics of fresh and dried tomatoes were evaluated. The average length of solar drying for the four treatments was 30 h and the Midilli and Kucuk mathematical model was the most adjusted. The acidity, reducing sugars and soluble solids were concentrated by drying, while ascorbic acid was reduced. The pH did not change. Tomatoes 'Carmen' can be dried in a handmade solar dryer for 30 h while maintaining product quality.

Entrada no ensino superior e envolvimento do estudante / Higher education entering and student engagement / Ingreso a la educación superior y participación estudiantil

No Ensino Superior, algumas experiências iniciais podem dificultar o envolvimento no novo ambiente académico. Este estudo analisa a relação entre a perceção sobre a entrada no Ensino Superior e o envolvimento do estudante. 784 estudantes do Ensino Superior responderam a um questionário sociodemográfico, a uma subescala do BES e à EAE-E4D. Os itens da subescala do BES foram organizados em três categorias: "Integração e acolhimento", "Nível de participação" e "Praxe". Os resultados indicam: diferenças significativas (teste t) entre os estudantes em função da idade, com os mais velhos mais envolvidos; correlações (Pearson) positivas e estatisticamente significativas entre as categorias do BES e a EAE-E4D; modelos ajustados (regressão linear múltipla) globalmente significativos e os coeficientes das variáveis "Integração e acolhimento" e "Nível de participação" estatisticamente significativos para a EAE-E4D global e dimensão afetiva. O processo de entrada tem efeito preditivo no envolvimento.

In Higher Education some early experiences may make it difficult to get engaged in the new academic setting. This study analyzes the relationship between the perception of entering higher education and student engagement. 784 higher education students answered to a sociodemographic questionnaire, a BES´ subscale and the EAE-E4D. The BES´ subscale items were organized into three categories: "Integration and Reception", "Participation Level" and "Hazing". The results indicate: significant differences (t-test) between students according to age, with the oldest more engaged; positive and statistically significant correlations (Pearson) between BES´ categories and EAE-E4D; globally significant adjusted models (multiple linear regression) and the coefficients of the variables "Integration and reception" and "Level of participation" statistically significant for the global EAE-E4D and its affective dimension. The entry process has a predictive effect on engagement.

En la enseñanza superior, algunas experiencias iniciales pueden dificultar la participación en el nuevo entorno académico. Este estudio analiza la relación entre la percepción sobre el ingreso a la enseñanza superior y la participación de los estudiantes. 784 estudiantes de enseñanza superior respondieron un cuestionario sociodemográfico, una subescala del BES y a la EAE-E4D. Los itens de la subescala BES se organizaron en tres categorías: "Integración y acogida", "Nivel de participación" y "Hábitos". Los resultados indican: diferencias significativas (test t) entre los estudiantes según la edad, con los mayores más involucrados; correlaciones positivas y estadísticamente significativas (Pearson) entre las categorías del BES y la EAE-E4D; modelos ajustados globalmente significativos (regresión lineal múltiple) y los coeficientes de las variables "Integración y acogida" y "Nivel de participación" estadísticamente significativos para el EAE-E4D global y la dimensión afectiva. El proceso de entrada tiene un efecto predictivo sobre la participación.

Early Prognostic Value of High-Sensitivity Troponin T after Coronary Artery Bypass Grafting.

BACKGROUND: Periprocedural myocardial injury after coronary artery bypass grafting (CABG) may affect the patient's prognosis and may be due to a different set of factors beyond the atherosclerotic plaque instability. Considering the challenges in the diagnosis of myocardial injury after CABG, the aim of this study was to determine the association between postoperative early elevation of high-sensitivity troponin T (hsTnT) and all-cause 30-day mortality after CABG. METHODS: We enrolled 600 consecutive patients who underwent CABG. The hsTnT value was measured immediately before surgery and in the morning of the first postoperative day. RESULTS: The baseline hsTnT was 13 ng/L (7-26 ng/L) and 273 patients (45.7%) had baseline hsTnT above the 99th percentile/upper reference limit (URL) (14 ng/L). The median for hsTnT at first postoperative day was 235 ng/L (152-425 ng/L). We calculated the postoperative hsTnT ratio to URL for each patient, representing the number of times exceeding the URL (hsTnT value divided by 14 ng/L). The multivariate analysis by Cox proportional hazard model revealed that age (years) (hazard ratio [HR] = 1.13, 95% confidence interval [CI]: 1.07-1.20; p < 0.001) and postoperative hsTnT ratio to URL (per 10-fold increase) (HR = 1.06, 95% CI: 1.04-1.08; p < 0.001) were independent predictors of all-cause 30-day mortality after CABG. CONCLUSION: In our series, age and higher postoperative hsTnT levels were independent and reliable predictors of all-cause 30-day mortality after CABG.

Processo de fabricação de comprimidos de lamivudina e zidovudina (150+300mg): avaliação retrospectiva da variabilidade e desenvolvimento de metodologia analítica por espectroscopia no infravermelho próximo com transformada de Fourier (FT-NIR) aplicada a avaliação da homogeneidade da mistura de pós / Lamivudine and zidovudine tablet manufacturing process (150 + 300mg): retrospective evaluation of the variability and development of analytical methodology by Fourier transform (FT-NIR) near infrared spectroscopy applied to the evaluation of homogeneity of the powder mixture

O uso de ferramentas estatísticas no ciclo de vida de um produto farmacêutico permite verificar e controlar o processo tendo como objetivo a sua melhoria contínua. No presente estudo foi avaliada a estabilidade e a capacidade estatística do processo de fabricação dos comprimidos revestidos de lamivudina 3TC e zidovudina AZT (150 + 300 mg) fabricados pela Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP). Esse medicamento, distribuido gratuitamente pelo programa DST/AIDS do Ministério da Saúde, e fabricado por compressão direta, processo rápido que permite a implementação futura da tecnologia analítica de processo (Process Analytical Technology - PAT). No Capítulo I foi realizada avaliação retrospectiva da variabilidade de atributos criticos da qualidade de 529 lotes dos comprimidos fabricados de acordo com a RDC ANVISA 17/2010 e as monografias oficiais, sendo tais atributos: peso médio, uniformidade de dose unitária e % m/v de fármaco dissolvido, antes e após o revestimento. O objetivo foi identificar eventuais causas especiais de variabilidade dos processos que permitam melhorias contínuas. No Capitulo II foi desenvolvida metodologia analítica empregando a espectroscopia no infravermelho próximo com transformada de Fourier para a avaliação da homogeneidade da mistura dos pós. Nesse estudo foram analisadas amostras de misturas dos fármacos lamivudina 3TC e zidovudina AZT e mistura excipiente, empregando como método de referência a CLAE, para a quantificação desses dois fármacos. No Capitulo I, a avaliação do processo para o peso médio revelou a necessidade de investigação das causa especiais de variabilidade, evidenciada por meio das cartas de controle. Os resultados do ano de 2015 indicaram necessidade de centralização e de consistência do processo, com redução de probabilidade de falha. As cartas de controle para uniformidade de dose unitária, no ano de 2013, revelaram menor variabilidade do processo. Porem, nesse ano, a análise estatística para a dissolução revelou processo descentralizado e sem consistência, com maior evidência para o fármaco 3TC que demonstrou menor desempenho, Cpk<1,0. A avaliação da estabilidade e da capacidade do processo de fabricação de comprimidos de lamivudina + zidovudina (150+300 mg), no período de 2012 a 2015, permitiu o maior entendimento de suas fontes de variação. Foi possível detectar e determinar o grau dessa variação e seu impacto no processo e nos atributos críticos de qualidade do produto com evidentes oportunidades de melhoria do processo, reduzindo os riscos para o paciente. No capítulo II, no desenvolvimento do método, as estatísticas de validação revelaram que os menores valores de BIAS foram observados para a 3TC, 0,000116 e 0,0021, respectivamente para validação cruzada e validação. Os valores de BIAS próximos a zero indicaram reduzida porcentagem de variabilidade do método. O presente estudo demonstrou a viabilidade do uso do modelo desenvolvido para a quantificação da 3TC e AZT por FT-NIR apos ajustes que contribuam para a elevação de R, R2 e RPD para valores aceitáveis. Valores de RPD acima de 5,0 que permitem o uso do modelo para uso em controle de qualidade

The use of statistical tools in the life cycle of a pharmaceutical product allows verifying and controlling the process aiming at its continuous improvement. In the present study, the stability and statistical capacity of the lamivudine coated tablets 3TC and zidovudine AZT (150 + 300 mg) manufactured by the Chopin Tavares de Lima Foundation (FURP) were evaluated. This drug, distributed free of charge by the Ministry of Health's DST/AIDS program, is manufactured by direct compression, a rapid process that allows the future implementation of Process Analytical Technology (PAT). In Chapter I, a retrospective evaluation of the variability of critical quality attributes of 529 batches of tablets manufactured was carried out, such attributes being: mean weight, unit dose uniformity and % m/v of dissolved drug substances, before and after coating. The objective was to identify possible special causes of variability of the processes that allow continuous improvements. In Chapter II an analytical methodology was developed employing the near infrared spectroscopy with Fourier transform for the evaluation of the homogeneity of the powder mixture. In this study, samples of mixtures of the drugs lamivudine 3TC and zidovudine AZT and excipient mixture were analyzed, using as reference method the HPLC, for the quantification of these two drugs. In Chapter I, the evaluation of the process for the mean weight revealed the need to investigate the special cause of variability, as evidenced by the charts. The results of the year 2015 indicated the need for centralization and process consistency, with a reduction in the probability of failure. The control charts for unit dose uniformity, in the year 2013, revealed less process variability. However, in that year, the statistical analysis for dissolution revealed a decentralized process with no consistency, with greater evidence for the 3TC drug that showed lower performance, Cpk<1.0. The evaluation of the stability and capacity of the lamivudine + zidovudine tablet manufacturing process (150 + 300 mg) in the period from 2012 to 2015 allowed a better understanding of its sources of variation. It was possible to detect and determine the degree of this variation and its impact on the process and the critical quality attributes of the product with evident opportunities to improve the process, reducing risks for the patient. In Chapter II, in the development of the method, the validation revealed that the lowest values of BIAS were observed for 3TC, 0.000116 and 0.0021, respectively for cross validation and validation. BIAS values close to zero indicated a reduced percentage of variability of the method. The present study demonstrated the feasibility of using the model developed for the quantification of 3TC and AZT by FT-NIR after adjustments that contribute to the elevation of R, R2 and RPD to acceptable values. RPD values above 5.0 that allow the use of the model for use in quality control

Influência da mata ciliar sobre a qualidade da água do ribeirão aurora, no município de Astorga, Paraná / The influence of the riparian forest over the aurora stream water qualaity in Astorga, Paraná

Foram avaliados os fatores que influenciam a qualidade da água na bacia do Ribeirão Aurora, Município de Astorga-PR, onde permanecem remanescentes de Floresta Estacional Semidecidual e predominam atividades de agricultura e pecuária extensiva análises de parâmetros físico-químicos e biológicos foram realizadas em época de seca e em época de chuvas. Para o pH, a variação foi pequena nas duas épocas. Quanto à cor, a variação ocorreu em época de chuvas, indicando um aumento de partículas que chegaram com a água escoada, ou daquelas depositadas no fundo do rio. A acentuada turbidez encontrada nas amostras obtidas na época das chuvas, deve-se ao aumento de partículas sólidas que foram carreadas para o rio. As concentrações de nitrato e de matéria orgânicas apresentaram valores elevados também em época de chuvas, o que indica o carreamento desse material através da lixiviação do solo.Quanto à dureza, provavelmente, a variação ocorreu devido ao carreamento de CaCO3 pelas águas superficiais. Baseados nestes parâmetros e comparados com os índices do Conama, a água deste rio é de boa qualidade.