Intelligent data analysis of clinical trials with Stata

Clinical trial statistical analysis and reporting is a formidable task. A final-study report requires the creation of hundreds of tables and data listings, and the calculation of over one thousand statistical significance levels, difference estimates, and confidence limits. Typically, several database programmers, statistical programmers, and biostatisticians are needed to perform this task over a period of time that is measured in months. I describe the design approaches and the evaluation of an intelligent data analysis system (DART) that automates the creation of clinical trial statistical reports, which is one component of an integrative Clinical Trials Information System. This application was developed in Stata programming language and has about 9,000 lines of code. This unsupervised knowledge-based system is able to select, according to the characteristics of the study design, the study statistical analysis plan and the type of baseline and efficacy variables used (which are all encoded and stored in the database), the statistical methods adequate for each analysis, and the results that need to be reported. The entire process of data analysis and reporting can be performed automatically, or the user may specify some parameters of the analysis (e.g., scale transformations, adjustment for confounding). The application can handle commonly used statistical methods applied to clinical trials analyses for nominal, multi-valued, ordinal, interval, and event/count data in one-, two-, and multiple-arm trials, crossover studies, and factorial designs, with or without stratification. It handles imputation of missing data, scale transformations, and regrouping of study centers. It can automatically select baseline variables for inclusion as covariates, and conduct poststratification analyses and subgroup analyses. So far, DART has been successfully used for the automated statistical reporting of 35 pharmaceutical clinical trials. In a validation study, the statistical methods used in a random sample of 51 clinical trials were published in The New England Journal of Medicine and in The Lancet, reporting 97 different analyses. The analytical methods were identical or equivalent to those selected by DART in 84.5% of the analyses, different from DART in 6.2%, and not supported by DART in 9.3%.

Prevalence and risk factors of inadequate medicine home storage: a community-based study

OBJECTIVE: Assess the extent of inadequate home storage of medicines andidentify important risk factors. METHODS: A cross-sectional survey based on a probability sample in the community, conducted in 267 households in Cuité, State of Paraíba, Northeast Brazil, in 2014. Logistic regression was used to study the risk factors. RESULTS: The prevalence of households with inadequate storage was 76.0%. Problems with storage include direct exposure to sunlight in 10.9% of households, the presence of dust in 23.6%, and storage within reach of children in 76.0%. Medications no longer used are usually disposed of into the environment in 92.1% of households. Inadequate storage is more likely when home organization of medications is the responsibility of a male subject (OR = 1.729) or an older person (OR = 1.029), when out of date medicines are found (OR = 2.963), and in households with no children (OR = 2.088). CONCLUSIONS: Physicians and pharmacists should advise patients on how to adequately store medicines at home, especially when the person in charge of medications is a male or an older adult, and if there are no children in the household

Mortalidade por doença renal crônica secundária à hipertensão no Brasil: um estudo do “Global Burden of Disease”

Background and Objectives: Chronic kidney disease (CKD) is one of the main complications resulting from arterial hypertension, and a recent increase in the incidence and prevalence of the disease has been reported, which can lead to an increase in mortality and complications resulting from the disease. Thus, the objective of study is to describe the variations in mortality from CKD secondary to arterial hypertension, in Brazil, between the years 1990 to 2019. Methods: Epidemiological study, with a quantitative approach and descriptive character, which analyzed data from the “Global Burden of Disease Study” (GBD) tool. Results: In all of Brazil’s federative units, the estimate of deaths from CKD secondary to hypertension increased, with the Southeast region having the highest estimates. The States of Rio de Janeiro, Rio Grande do Sul, and Paraíba lead with the highest mortality rates. Regarding sex, in all years, higher rates were observed in males, however, over the years, this difference has been reduced. The age group of ≥70 years was the most affected, standing out with the highest death rates. Conclusion: the burden of CKD in Brazil has increased in the last 30 years; among the regions of the country, the Southeast recorded the highest estimates of deaths in all the years analyzed, being mainly higher among men.Justificación y objetivos: La enfermedad renal crónica (ERC) es una de las principales complicaciones derivadas de la hipertensión arterial, y en los últimos años se ha reportado un aumento en la incidencia y prevalencia de la enfermedad, lo que puede conducir a un aumento de la mortalidad y de las complicaciones derivadas de esta, por lo tanto, el objetivo del estudio es describir las variaciones en la mortalidad por ERC secundaria a la hipertensión arterial en Brasil entre los años 1990 a 2019. Métodos: Estudio epidemiológico, con enfoque cuantitativo y carácter descriptivo, que analizó datos de la herramienta Global Burden of Disease Study (GBD). Resultados: En todas las unidades de la federación, aumentó la estimación de muertes por ERC secundaria a la hipertensión arterial, con la región Sudeste presentando las estimaciones más altas. Los estados de Rio de Janeiro, Rio Grande do Sul y Paraíba lideran con las tasas de mortalidad más altas. Con respecto al sexo, en todos los años se observaron mayores tasas en los varones, sin embargo, con el paso de los años, esta diferencia se ha ido reduciendo. El grupo de edad de ≥70 años fue el más afectado, destacándose con las tasas de mortalidad más altas. Conclusión: la carga de ERC en Brasil ha aumentado en los últimos 30 años; de las regiones del país, el Sudeste registró las mayores estimaciones de muertes en todos los años registrados entre los analizados, siendo principalmente mayor entre los hombres.Justificativa e objetivos: A doença renal crônica (DRC) é uma das principais complicações decorrentes da hipertensão arterial. Nos últimos anos, tem sido relatado um aumento na incidência e prevalência da doença, o que pode levar ao aumento da mortalidade e das complicações decorrentes da doença. Assim, o objetivo deste estudo foi descrever as variações da mortalidade por DRC secundária à hipertensão arterial no Brasil entre 1990 e 2019. Métodos: Trata-se de um estudo epidemiológico, de abordagem quantitativa e caráter descritivo, que analisou dados da ferramenta Global Burden of Disease Study (GBD). Resultados: Em todas as unidades da federação, a estimativa de mortes por DRC secundária à hipertensão apresentou aumento, a região Sudeste apresentando as maiores estimativas. Os estados do Rio de Janeiro, Rio Grande do Sul e Paraíba lideram as pesquisas com as maiores taxas de mortalidade. No que diz respeito ao sexo, em todos os anos foram observadas maiores taxas de DRC em indivíduos do sexo masculino; contudo, nota-se que tem ocorrido uma redução dessa diferença. A faixa etária de ≥70 anos foi a mais acometida, destacando-se com as maiores taxas de mortes. Conclusão: a carga de DRC no Brasil aumentou nos últimos 30 anos. Entre as regiões do país, o Sudeste registrou as maiores estimativas de mortes em todos os anos analisados, principalmente de homens

Considerações sobre perfil motivacional e articulação de conceitos em química orgânica

O presente trabalho descreve investigação sobre o papel da motivação sobre a articulação conceitual em estudantes de graduação resolvendo tarefas de Química Orgânica coletivamente. Ao todo, 7 grupos foram analisados resolvendo tarefas em uma disciplina introdutória de Química Orgânica. Subsidiaram a análise a Teoria dos Campos Conceituais e Teoria da Autodeterminação. A análise de dados contou registros audiovisuais e notas de campo que balizaram Análise Textual Discursiva efetuada com o auxílio do Software Transana®. Como resultado conclui-se que aspectos motivacionais influenciam no estilo de enfrentamento de problemas pelos estudantes no campo da estrutura e reatividade de compostos orgânicos muito embora a motivação intrínseca não seja garantia da ocorrência de fragilidades conceituais

Targeting Macrophages and Synoviocytes Intracellular Milieu to Augment Anti?Inflammatory Drug Potency

Using a preclinical in vivo model of arthritis and the gold standard disease-modifying anti-rheumatic drug, methotrexate, pH-responsive phosphorylcholine polymersomes, elicit both anti-inflammatory and anti-arthritic therapeutic efficacy, while drastically minimizing off-target toxicity. First, the selective accumulation of polymersomes within synovium of inflamed joints. Second, the polymersomes targeting ability toward activated macrophages and synoviocytes, via scavenger receptors, allow their uptake via endocytosis. And third, the polymersomes pH-responsiveness enables the drug escape from early endosomes and hence its intracellular milieu delivery. On-site augment of methotrexate loaded polymersomes enable the complete abrogation of synovial inflammation and prevent the disease progression and severity. Overall, in vitro and in vivo investigations reveal the potential of polymersomes as a promising nanotherapy for treating arthritic inflammation

DMSO removal reduces stem-cell infusion-related toxicity and allows excellent engraftment of cryopreserved unrelated cord blood and autologous stem cells

UNIFESP, GRAACC, Pediat Oncol Inst, São Paulo, BrazilUniversidade Federal de São Paulo, São Paulo, BrazilUNIFESP, GRAACC, Pediat Oncol Inst, São Paulo, BrazilUniversidade Federal de São Paulo, São Paulo, BrazilWeb of Scienc

Large volume leukapheresis for autologous peripheral blood stem cell collection in children weighting less than 25 kg

Universidade Federal de São Paulo, GRAACC, Pediat Oncol Inst, São Paulo, BrazilUniversidade Federal de São Paulo, Dept Pathol, São Paulo, BrazilUniversidade Federal de São Paulo, GRAACC, Pediat Oncol Inst, São Paulo, BrazilUniversidade Federal de São Paulo, Dept Pathol, São Paulo, BrazilWeb of Scienc

HIGH DOSE CARBOPLATIN, ETOPOSIDE, MELPHALAN and AUTOLOGOUS HEMATOPOIETIC STEM CELL RESCUE WITH for the TREATMENT of RELAPSED PEDIATRIC GERM CELL TUMORS

Inst Oncol Pediat, São Paulo, BrazilWeb of Scienc

Eficiência fisiológica e desempenho do amendoim sob estresse salino e inoculado com Bradyrhizobium

In this work, we sought to know the effects of water salinity on peanut plants and whether inoculation with a mixture of Bradyirhizobium would be effective in reducing the effects and improving performance.. The experimental design was completely randomized, with a 4x2 factorial arrangement, four levels of water salinity (0,5 dSm-1 - controle), 1,5 dSm-1, 3 dSm-1, 4,5 dSm-1) and plants inoculated and not inoculated with Bradyrhizobium sp., totaling 8 treatments and 4 repetitions. For the gas exchange evaluations made at 55 days after sowing, two variables were used: instantaneous efficiency of carboxylation and photochemical efficiency of photosynthesis, of growth: plant height, stem diameter, number of leaves and leaf area, all made at 65 days after sowing, with the aid of a millimeter ruler and a caliper. In relation to biomass: area dry matter, root dry matter and total dry matter, at 70 days after sowing. Fixing bacteria helped in the production of molecules that helped and fortified the physiological apparatus and gave an increase in growth variables. The mix of rhizobia (Bradyrhizobium sp.) were efficient in the production of molecules that mitigate the effects of salts, with that the plants had a better physiological performance, in the accumulation of biomass and growth.Neste trabalho buscou-se saber os efeitos da salinidade da água sob as plantas de amendoim e se a inoculação com um mix de Bradyirhizobium seria eficaz em reduzir os efeitos e melhorar o desempenho. O delineamento experimental foi o inteiramente casualizado, com arranjo fatorial 4x2, quatro níveis de salinidade da água (0,5 dSm-1 - controle, 1,5 dSm-1, 3 dSm-1, 4,5 dSm-1) e plantas inoculadas e não inoculadas com Bradyrhizobium sp., totalizando 8 tratamentos e 4 repetições. Para as avaliações de trocas gasosas feitas aos 55 dias após a semeadura realizou-se duas variáveis: eficiencia instantanea da carboxilação e eficiencia fotoquimica da fotossintese, de crescimento: altura de planta, diâmetro do caule, número de folhas e área foliar, todas feitas aos 65 dias após a semeadura, com auxílio de uma régua milimétrica e um paquímetro. Em relação a biomassa: matéria seca da parte área, matéria seca da raiz e matéria seca total, aos 70 dias após a semeadura. As bactérias fixadoras auxiliaram na produção de moléculas que auxiliaram e fortificaram o aparato fisiológico e deram um incremento nas variáveis de crescimento. O mix de rizóbio (Bradyrhizobium sp.) foram eficientes na produção de moléculas que amenizassem os efeitos do sais, com isso as plantas tiveram um melhor desempenho fisiológico, no acumulo de biomassa e crescimento