Sequential Allocation and Balancing Prognostic Factors in a Psychiatric Clinical Trial

In controlled clinical trials, each of several prognostic factors should be balanced across the trial arms. Traditional restricted randomization may be proved inadequate especially with small sample sizes. In psychiatric disorders such as obsessive compulsive disorder (OCD), small trials prevail. Therefore, procedures to minimize the chance of imbalance between treatment arms are advisable. This paper describes a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients. Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one. Partial results of this allocation procedure as well as simulated ones are shown. In the clinical trial for which this procedure was developed, the balancing between treatment arms was achieved successfully. Simulations of results considering different arrival order of patients showed that most of the patients are allocated in a different treatment arm if arrival order is modified. Results show that a random factor is maintained with the random arrival order of patients. This specific procedure allows the use of a large number of prognostic factors for the allocation decision and was proved adequate for a psychiatric trial design

Métodos de enriquecimento de cultura mista utilizada no tratamento de vinhaça para a produção biológica de hidrogênio

Tese (doutorado) - Universidade Federal de Santa Catarina, Centro Tecnológico, Programa de Pós-Graduação em Engenharia de Alimentos, Florianópolis, 2014.O processo biológico de produção de H2 via fermentação é tido como promissor, pois possibilita produzir H2 a partir de águas residuárias domésticas ou industriais. O objetivo deste trabalho foi estudar métodos de pré-tratamentode uma cultura mista anaeróbia, utilizada no tratamento de vinhaça, visando a seleção e o enriquecimento em microrganismos produtores de H2, avaliando o efeito dos pré-tratamentos sobre a comunidade microbiana.Foram realizados os seguintes pré-tratamentos: 1) Tratamento térmico a 100°C por 15 min; 2) Tratamento térmico a 100°C por 60 min; 3) Tratamento térmico a 80°C por 15 min; 4) Tratamento térmico a 80°C por 60 min; 5) Tratamento ácido (pH 3/24 h); 6) Tratamento combinado (pH 3 e fervura por 30 min); 7 e 8) Lavagem seletiva do lodo em biorreator contínuo, operado a 50°C com TRH de 12 h e 6 h. A produção de hidrogênio pelos lodos pré-tratados foi verificada em ensaios em batelada a 50°C durante, aproximadamente, 24 h. Os tratamentos produziram 109, 71, 154, 139, 117, 72, 0,6 e 0,75 mL, respectivamente e o controle (sem tratamento) 31 mL de hidrogênio. Analisou-se a comunidade microbiana dos lodos pré-tratados através de análise de DGGE (Denaturing Gradient Gel Electrophoresis) e sequenciamento (Ion Torrent personal genome machine). Os pré-tratamentos térmico a 80°C por 15 min e o ácido pH 3 por 24 h foram considerados os mais apropriados para o enriquecimento do lodo proveniente de um sistema de tratamento de vinhaça rica em bactérias produtoras de H2. Então, foi feito um estudo para encontrar a melhor relação S0/X0 para produção de H2desses dois tratamentos. A melhor relação S0/X0encontrada foi 2,0. Os lodos tratados térmicamente e tratado com ácido foram utilizados como inóculo de biorreatores operados em batelada alimentada por 36 dias e com S0/X0de 2,0, para verificar o comportamento da produção de H2 em longo prazo. Nos 36 dias de operação foi analisada a produção de H2e a comunidade microbiana inicial e final dos biorreatores através de análise de DGGE e sequenciamento. O tratamento com ácido foi o tratamento que teve melhor resultado na produção de hidrogênio em 36 dias.E o gênero mais frequente encontrado no lodo tratado com ácido foi o Thermoanaerobacterium spp., conhecida na iteratura como produtora de hidrogênio.Abstract: The biological process of H2 production via fermentation is seen as promising because it enables to produce H2 from domestic or industrial wastewater. The objective of this work was to study methods of pretreatment of mixed anaerobic culture used in the treatment of vinasse in order to select and enrich for microorganisms that produce H2, evaluating the effect of pre-treatments on the microbial community. The following pretreatments were carried out: 1) Heat treatment at 100 °C for 15 min 2) Heat treatment at 100 °C for 60 min; 3) Heat treatment at 80 °C for 15 min; 4) Heat treatment at 80 °C for 60 min; 5) acid treatment (pH 3/24 h); 6) Combined treatment (pH 3, and boiling for 30 min); 7 and 8) Dry selective sludge bioreactor continuously operated at 50 °C with HRT of 6 h and 12 h. Hydrogen production by pre-treated sludge was observed in batch tests at 50 °C for approximately 24 h. The treatment produced 109, 71, 154, 139, 117, 72, 0.6 and 0.75 mL, respectively and control (untreated) 31 mL of hydrogen. We analyzed the microbial community of the pretreated sludge through analysis of DGGE (Denaturing Gradient Gel Electrophoresis) and sequencing (Ion Torrent Personal Genome Machine). The thermal pre-treatment at 80 °C for 15 min and the acid pH 3 for 24 h were considered the most appropriate for the enrichment of the sludge from a treatment system for producing bacteria vinasse rich H2. So a study was done to find the best S0/X0 ratio for H2 production of these two treatments. The best S0/X0 ratio found was 2.0. The heat treated sludge and treated with acid was used as inoculum bioreactor operated in batch fed for 36 days with S0/X0 2.0, to verify the behavior of H2 production in the long term. In the 36 days of operation was analyzed to produce H2 and the initial end of bioreactors and microbial community analysis using DGGE and sequencing. The acid treatment was the treatment I had better result in hydrogen production in 36 days. And the most common genus found in sludge treated with acid was Thermoanaerobacterium sp. Known as the iteratura hydrogen producer

The discontinuity and emptying of educational dimension in environmental education actions performed at school

[Resumo] A intervenção humana no ambiente, sob o modo capitalista de produção, é permeada por disputas pela apropriação do patrimônio ambiental entre grupos humanos com diferentes interesses. Nesse modelo, impactos ambientais são também sociais, políticos, éticos e econômicos - fortalecendo a tese de que ele deve ser superado. Assim, a Educação Ambiental (EA) crítica é um elemento-chave por enfrentar as injustiças socioambientais, sendo a escola fundamental ao permitir a apropriação das objetivações humanas e a realização de ações educacionais contínuas, características que permitem processos educativos de qualidade. Nesse sentido, objetivamos discutir a descontinuidade e o esvaziamento da dimensão educativa da EA escolar. Com dados de estudos do Grupo de Pesquisa em Educação Ambiental (GPEA) da UNESP/Bauru/SP/Brasil, observamos que a EA escolar tende a ser pontual, com projetos, campanhas, palestras, seminários e oficinas, ou seja, acontece de forma descontínua e esvaziada da dimensão educativa. Nesse cenário, consideramos que a EA deve se constituir como tema nuclear no currículo, superar o conservadorismo, ter fundamentação teórica crítica e primar pela dimensão educativa. O avanço proposto pode gerar os elementos para elucidar a luta pela apropriação ambiental e a dicotomia nas relações sociedade/natureza, rumo a sua superação e à emancipação humana[Abstract] On the capitalist mode of production, human intervention in the environment is permeated by disputes for the appropriation of the environmental heritage among human groups with different interests. In this model, environmental impacts are also social, political, sthical and econoimical – straightening the thesis that we must overcome it. Therefore, Critical Environmental Education (EE) is a key element to confront socio-environmental injustices - as well as school, once it enables the appropriation of human objectifications and the performing of continuous educational actions (feature that brings quality to educational processes). Thereby, we aim to discuss the discontinuity and the emptying of educational dimension of School EE. Taking data collected by Grupo de Pesquisa em Educação Ambiental (GPEA) – UNESP/Bauru/SP/Brazil, we observed School EE tends to be punctual (projects, campaigns, lectures, seminars, workshops), namely it has no continuity and is empty of its educational dimension. In this scenario, we consider EE must be a nuclear theme in curriculum, overcome conservatism, have critical theoretical framework and seek for its educational dimension. These suggestions may bring forth the required elements to understand the fight for environmental appropriation and the dichotomy in the society/nature relations towards its overcoming and human emancipation

Testing allele homogeneity: the problem of nested hypotheses

Background: The evaluation of associations between genotypes and diseases in a case-control framework plays an important role in genetic epidemiology. This paper focuses on the evaluation of the homogeneity of both genotypic and allelic frequencies. The traditional test that is used to check allelic homogeneity is known to be valid only under Hardy-Weinberg equilibrium, a property that may not hold in practice. Results: We first describe the flaws of the traditional (chi-squared) tests for both allelic and genotypic homogeneity. Besides the known problem of the allelic procedure, we show that whenever these tests are used, an incoherence may arise: sometimes the genotypic homogeneity hypothesis is not rejected, but the allelic hypothesis is. As we argue, this is logically impossible. Some methods that were recently proposed implicitly rely on the idea that this does not happen. In an attempt to correct this incoherence, we describe an alternative frequentist approach that is appropriate even when Hardy-Weinberg equilibrium does not hold. It is then shown that the problem remains and is intrinsic of frequentist procedures. Finally, we introduce the Full Bayesian Significance Test to test both hypotheses and prove that the incoherence cannot happen with these new tests. To illustrate this, all five tests are applied to real and simulated datasets. Using the celebrated power analysis, we show that the Bayesian method is comparable to the frequentist one and has the advantage of being coherent. Conclusions: Contrary to more traditional approaches, the Full Bayesian Significance Test for association studies provides a simple, coherent and powerful tool for detecting associations

Sequential Allocation to Balance Prognostic Factors in a Psychiatric Clinical Trial

OBJECTIVE: This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients. METHOD: Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one. RESULTS: We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment. CONCLUSION: Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov NCT00466609 and NCT00680602

La calidad de vida de las madres de niños trabajadores en las calles de São Paulo, Brasil

The present study evaluated the perceived quality of life of the mothers of street children and investigated the association with their history of childhood violence, the occurrence of current domestic violence, their current mental states and that of their children, and family functioning. the applied instruments were as follows: Strengths and Difficulties Questionnaire, WorldSAFECore Questionnaire, Instrument for the Assessment of Quality of Life of the WHO, Global Assessment of Relational Functioning Scale, Childhood Trauma Questionnaire and a socio-demographic questionnaire. the sample of convenience consisted of 79 low-income mothers who raised their children alone, and most of whom had a positive screening for mental illness. the multiple regression analysis showed that the perception of quality of life of these women was associated with the presence of psychopathology either in themselves or their children and family dysfunction. Thus any program aimed at improving the quality of life of such mothers should consider addressing their mental problems as well as those of their children, besides offering educational and psychotherapeutic approaches to these families to improve the social environment.Universidade Federal de São Paulo, Dept Psiquiatria, BR-04038020 São Paulo, SP, BrazilUniv São Paulo, Inst Matemat & Estat, São Paulo, BrazilUniversidade Federal de São Paulo, Dept Psiquiatria, BR-04038020 São Paulo, SP, BrazilWeb of Scienc