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- ItemAcesso aberto (Open Access)A saúde no núcleo de Educação Infantil Paulistinha da Universidade Federal de São Paulo: uma análise documental(Universidade Federal de São Paulo (UNIFESP), 2016-10-31) Paz, Adriana Oliveira [UNIFESP]; Gerab, Irani Ferreira da Silva [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)This research had as its main objective the analysis of health concepts and practices in the pedagogical project of the Early Childhood Education Center Paulistinha of the Universidade Federal de São Paulo (University of São Paulo) taking into account the official guidelines for education. The theoretical basis in which this research is based embraces the concepts of health, school children?s health and health education. Qualitative methods were used in this research and through the documental research nine official documents were analyzed, among those the Federal Education Guideline Law (Lei de Diretrizes e Bases da Educação Nacional), the Brazilian Federal Constitution, the Curricular Parameters and Guideline for Early Childhood Education (Parâmetros e Diretrizes Curriculares Nacionais para a Educação Infantil) and the Quality Indicator for Early Childhood Education. Two school documents were also analyzed: the school academic plan and the school statute. The data collected underwent a thematic content analysis. This research was approved by the Research Ethics Committee of the University of São Paulo. In the official documents were observed as a central theme the ?right to health?, from which the following dimensions were highlighted: promotion of health; global development; relation between care and education; safety and protection as health factors. In the documents from the Early Childhood Education Center Paulistinha it was possible to observe that besides the emphasis on the health context in which the Center is situated there is also the comprehension of the full development of children as a person as an institutional goal. As a result of this research a technical report that highlights improvements on school children?s health was produced in order to contribute in the production of the new pedagogical project of NEI-Paulistinha, process though which the school is in at the moment.
- ItemSomente MetadadadosViés de publicação em ensaios clínicos sobre anticorpos monoclonais e repercussão jurídica do direito fundamental à saúde baseada em evidências(Universidade Federal de São Paulo (UNIFESP), 2014-12-31) Santos, Douglas Henrique Marin dos [UNIFESP]; Atallah, Alvaro Nagib Atallah [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Aims: We aimed to assess the proportion of publication and reporting of results of clinical trials on monoclonal antibodies adalimumab, bevacizumab, rituximab, trastuzumab and infliximab registered at ClinicalTrials.gov. We also aimed to evaluate the circumstances associated to publications bias and the effectiveness of FDAAA legislation in controlling it. Methods: In this cross-sectional, we searched ClinicalTrials.gov for protocols of interventional studies, phases III and IV, on monoclonal antibodies adalimumab, bevacizumab, rituximab, trastuzumab and infliximab, interventional (n = 243). After, we searched Pubmed, Embase, Lilacs, Cochrane Central and Google Scholar in order to evaluate and find published papers. Results: Among the 243 trials that comprised our initial sample, 178 (?73,2%) were published and 73 (?30%) had results reported at ClinicalTrials.gov. Industry sponsored trials were 169 (? 69.5%). Regarding the methodological quality of protocols, 159 (?65,4%) trials were designed with two or more comparison groups (intervention versus control), 149 (?61,3%) were randomized and 84 (?34,5%) were masked. Only 82 trials (?33,7%) were cumulatively designed with control groups, randomized allocation of participants, and masking. Among published studies (n=178), 118 (?66,3%) reported positive results, 18 (? 10%) reported negative results, 11 (?6,2%) found neutral or inconclusive results, and 24 (?13,5%) were partially positive. In the subsample of trials under FDAAA mandatory reporting (n=57), 48 (?84.2%) were published and 40 (?70,2%) had their results disclosed at ClinicalTrials.gov. Placebo-controlled trials were significantly more common among industry-funded trials when compared with independent trials (n=44/169 [26%] versus 9/74 [?12,2%]; p=0,025). Treatment as usual controlled trials were significantly more common among independent studies when compared to industry-funded trials (n=36/74 [?48.6%] versus 44/169 [?26%]; p<0,001). Conclusions: Publication bias in clinical trials is intense, despite the nature of intervention investigated (in this case, monoclonal antibodies). The source of funding (independent or industry) did not change the patterns of publication, suggesting that publication bias is evenly spread among different sponsors. However, studies involving placebo or single arm studies were more common in industry-funded trials. Our findings also suggest a higher prevalence of positive results among published trials. Lack of transparency, therefore, goes beyond selective publications and encompasses poor designed and biased protocols. Clinical trials subject to the FDAAA legislation had a greater proportion of published studies and disclosed results at ClinicalTrials.gov, suggesting the effectiveness of U.S. law in controlling publication bias and expanding in clinical research.