Avaliação da qualidade dos ensaios clínicos aleatórios em terapia intensiva

Abstract

Objective: A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. Methods: All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Results: Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. Conclusion: It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.

A qualidade dos ensaios clínicos randomizados publicados no Jornal Vascular Brasileiro

“…Entretanto, é relevante salientar que no texto do artigo 9 menciona-se apenas o método de distribuição aleatória como sorteio, e o fato de os autores descreverem que o estudo foi aleatório não assegura ao leitor ou a quem avalia o artigo que a pesquisa teve um método adequado 14 . A randomização consiste em alocar os indiví-duos aleatoriamente nos grupos a serem comparados.…”