Guidelines para publicação de estudos científicos. Parte 3
Como publicar ensaios clínicos
Palavras-chave:
Ensaio clínico, componentes de publicações, formatos de publicação, viés de publicação, manuais e guias para a gestão da pesquisa, medicina baseada em evidênciasResumo
Introdução: Apesar da importância do relato adequado de estudos científicos, muitos ensaios clínicos continuam sendo publicados inadequadamente, com a exposição incompleta ou ambígua de seus métodos e resultados, dificultando conclusões sólidas sobre a efetividade da intervenção estudada e sobre a reprodutibilidade dos procedimentos. Várias guidelines foram elaboradas com o objetivo de melhorar o relato e aumentar a transparência dos estudos científicos na área da saúde. Objetivos: Apresentar a ferramenta CONSORT (CONsolidated Standards of Reporting Trials), suas extensões e ferramentas derivadas, que objetivam orientar a redação de artigos baseados em ensaios clínicos. Métodos: Estudo descritivo e de análise crítica realizado na Disciplina de Medicina Baseada em Evidências da Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp), com busca da literatura. Resultados: A busca inicial resultou em 18 ferramentas. Foram incluídas a ferramenta CONSORT original e 17 extensões e ferramentas derivadas, elaboradas para desenhos ou situações clínicas mais específicos. Conclusão: O relato de estudos científicos deve ser realizado de forma clara, transparente e completa, ou seja, apresentar todas as informações que são necessárias para a interpretação e a reprodutibilidade do estudo, sem ocultação de detalhes importantes. A ferramenta CONSORT e suas extensões derivadas são essenciais para a adequação do relato de ensaios clínicos e seu uso deve ser incentivado.
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