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Crianças com doença crónica em ensaios clínicos pediátricos : um caso de estudo em bronquiolite aguda
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INTRODUÇÃO: Na Bronquiolite Aguda, a investigação científica é escassa o que leva à instituição de terapêutica em regime “off-label”. Crianças ex prematuras ou com doença crónica estão classificadas como grupo de risco, sendo este quem mais pode beneficiar com os estudos clínicos. O objetivo deste trabalho é averiguar como estão a ser incluídas as crianças com patologia crónica nos estudos científicos.
MÉTODOS: Utilizando o termo “bronchiolitis” na base de dados da Cochrane obteve-se um número de revisões sistemáticas que foram submetidas aos seguintes critérios de inclusão: Incluir um RCT (Randomised controlled trial); Sem limite de idade ou de barreira linguística; Qualquer definição de bronquiolite aguda; Em qualquer ambiente de cuidados; A intervenção tenha como finalidade o tratamento (independentemente do meio de intervenção); Qualquer outcome. Foram retirados os artigos científicos incluídos nas revisões sistemáticas selecionadas. O outcome primário diz respeito aos critérios de exclusão.
RESULTADOS: Extraíram-se 30 revisões sistemáticas da Cochrane referentes a “bronchiolitis”. Apenas 13 cumpriam os critérios de inclusão e destas foram extraídos os artigos de inclusão das referências bibliográficas, tendo-se obtido 139 artigos científicos. Deste total de 139 artigos, 28 encontram-se repetidos e 17 não estão disponíveis online. Deste modo é alcançado um total de 94 artigos científicos elegíveis.
Os resultados mostram que há uma grande heterogeneidade nos critérios de exclusão dos artigos científicos mas que, em geral, as crianças com patologia crónica são excluídas, visto que 87% dos artigos excluem pelo menos uma patologia crónica.
DISCUSSÃO: Os doentes com bronquiolite aguda, portadores de doença crónica ou ex-prematuros, são os que apresentam maior taxa de hospitalização e, por isso, os que mais beneficiariam com os estudos clínicos. Contudo, é este grupo de doentes que é atualmente excluído.
INTRODUCTION: Scientific research is scarce in acute bronchiolitis leading that therapeutic must be implemented in "off-label" regimen. Ex-preterm children or children diagnosed with chronic illness are classified in the risk group, which are those who can take more benefit from clinical studies. The objective of this study is to investigate how children with chronic pathologies are being included in scientific studies. METHODS: Using the term " bronchiolitis " in the Cochrane database, a number of systematic reviews was obtained that have been submitted to the following inclusion criteria: Include a RCT (Randomised Controlled Trial); No age limit or language barrier; Any definition of acute bronchiolitis; In any care environment; The intervention has the purpose of the treatment (regardless of the means of intervention); Any outcome. Scientific articles included in the selected systematic reviews were removed. The primary outcome regards the exclusion criteria. RESULTS: 30 systematic reviews were extracted from Cochrane related to "bronchiolitis". Only 13 met the inclusion criteria and from those the inclusion articles were extracted from their references, having obtained a total of 139 scientific articles. Of this total, 28 are repeated and 17 are not available online. Thereby making a total of 94 eligible scientific articles for this study. The results show that there is great heterogeneity in the exclusion criteria of scientific articles but generally children with chronic disease are excluded, since 87% of the articles exclude at least one chronic disease. DISCUSSION: Patients with acute bronchiolitis, chronic disease patients or ex-preterm, are those with higher hospitalization rate and so those who would benefit more from the clinical studies. However, this is the group of patients that is currently excluded.
INTRODUCTION: Scientific research is scarce in acute bronchiolitis leading that therapeutic must be implemented in "off-label" regimen. Ex-preterm children or children diagnosed with chronic illness are classified in the risk group, which are those who can take more benefit from clinical studies. The objective of this study is to investigate how children with chronic pathologies are being included in scientific studies. METHODS: Using the term " bronchiolitis " in the Cochrane database, a number of systematic reviews was obtained that have been submitted to the following inclusion criteria: Include a RCT (Randomised Controlled Trial); No age limit or language barrier; Any definition of acute bronchiolitis; In any care environment; The intervention has the purpose of the treatment (regardless of the means of intervention); Any outcome. Scientific articles included in the selected systematic reviews were removed. The primary outcome regards the exclusion criteria. RESULTS: 30 systematic reviews were extracted from Cochrane related to "bronchiolitis". Only 13 met the inclusion criteria and from those the inclusion articles were extracted from their references, having obtained a total of 139 scientific articles. Of this total, 28 are repeated and 17 are not available online. Thereby making a total of 94 eligible scientific articles for this study. The results show that there is great heterogeneity in the exclusion criteria of scientific articles but generally children with chronic disease are excluded, since 87% of the articles exclude at least one chronic disease. DISCUSSION: Patients with acute bronchiolitis, chronic disease patients or ex-preterm, are those with higher hospitalization rate and so those who would benefit more from the clinical studies. However, this is the group of patients that is currently excluded.
Descrição
Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2016
Palavras-chave
Bronquiolite aguda Doenças crónicas Pediatria