Em razão da recomendação da Organização Mundial da Saúde sobre o uso do sistema mycobacteria growth indicator tube (MGIT) 960 para o diagnóstico de tuberculose e da falta de evidências sobre o impacto clínico de sua incorporação em sistemas de saúde, um ensaio clínico pragmático está sendo conduzido para avaliar o desempenho clínico e a relação custo-efetividade do MGIT 960 em duas unidades do Sistema Único de Saúde na cidade do Rio de Janeiro, que tem uma elevada incidência de tuberculose. Apresentamos aqui, de forma sintética, o método e resultados preliminares do ensaio. (ISRCTN.org Identifier: ISRCTN79888843 [http://isrctn.org/])

In view of the fact that the World Health Organization has recommended the use of the mycobacteria growth indicator tube (MGIT) 960 system for the diagnosis of tuberculosis and that there is as yet no evidence regarding the clinical impact of its use in health care systems, we conducted a pragmatic clinical trial to evaluate the clinical performance and cost-effectiveness of the use of MGIT 960 at two health care facilities in the city of Rio de Janeiro, Brazil, where the incidence of tuberculosis is high. Here, we summarize the methodology and preliminary results of the trial. (ISRCTN.org Identifier: ISRCTN79888843 [http://isrctn.org/])

In this manuscript, we report the current situation of tuberculosis globally and in Brazil, the need for new strategies toward tuberculosis control, focusing on new diagnostic technologies. Critical comments are given on the state of the art regarding the evaluation of new health technologies, degree of scientific evidence needed, evaluation of clinical impact, cost-effectiveness of incorporation into the health system and the social impact.