Evaluation of the impact that the changes in tuberculosis treatment implemented in Brazil in 2009 have had on disease control in the country

Abstract

Objective:To analyze the impact that the 2009 changes in tuberculosis treatment in Brazil had on the rates of cure, tuberculosis recurrence, mortality, treatment abandonment, and multidrug-resistant tuberculosis (MDR-TB). Methods:An ordinary least squares regression model was used in order to perform an interrupted time series analysis of secondary data collected from the Brazilian Tuberculosis Case Registry Database for the period between January of 2003 and December of 2014. Results:The 2009 changes in tuberculosis treatment in Brazil were found to have no association with reductions in the total number of cases (β = 2.17; 95% CI: −3.80 to 8.14; p = 0.47) and in the number of new cases (β = −0.97; 95% CI: −5.89 to 3.94; p = 0.70), as well as having no association with treatment abandonment rates (β = 0.40; 95% CI: −1.12 to 1.93; p = 0.60). The changes in tuberculosis treatment also showed a trend toward an association with decreased cure rates (β = −4.14; 95% CI: −8.63 to 0.34; p = 0.07), as well as an association with increased mortality from pulmonary tuberculosis (β = 0.77; 95% CI: 0.16 to 1.38; p = 0.01). Although there was a significant increase in MDR-TB before and after the changes (p < 0.0001), there was no association between the intervention (i.e., the changes in tuberculosis treatment) and the increase in MDR-TB cases. Conclusions:The changes in tuberculosis treatment were unable to contain the decrease in cure rates, the increase in treatment abandonment rates, and the increase in MDR-TB rates, being associated with increased mortality from pulmonary tuberculosis during the study period.Keywords: Tuberculosis, pulmonary/epidemiology; Tuberculosis, pulmonary/drug therapy; Tuberculosis, pulmonary/mortality; Interrupted time series analysis; Drug resistance, multiple; Drug compounding.

Reflections upon the article “Evaluation of the impact that the changes in tuberculosis treatment implemented in Brazil in 2009 have had on disease control in the country”

“…Conversely, the use of interrupted time series analysis techniques requires meeting some conditions, the most important of which being that the only change affecting the outcome measure in the period is the intervention of interest. 3 , 4 An article by Linden, 5 which was used by Rabahi et al 1 as a reference for performing interrupted time series analysis, also reinforces that caution is needed in drawing inferences when potential confounding factors, such as concomitant policies and programs, vary during the study period. It is known that, during the period studied by Rabahi et al, 1 other important changes occurred that could affect treatment outcomes, such as the lack of nationwide use of tuberculin testing within the health care system; the improvement in diagnosis, with the implementation of the Xpert MTB/RIF assay 6 ; and the economic crisis that unequally affected the population at highest risk for unfavorable treatment outcomes because of their social vulnerability.…”

“…In the article by Rabahi et al 1 published in volume 43, issue 6, of the JBP in 2017, the authors concluded that “The changes in tuberculosis treatment [fixed-dose combination implemented by the Brazilian Ministry of Health] were unable to contain the decrease in cure rates, the increase in treatment abandonment rates, and the increase in [multidrug-resistant tuberculosis] MDR-TB rates, being associated with increased mortality from pulmonary tuberculosis during the study period.” Considering that this statement published in the major means of scientific dissemination of the Brazilian Thoracic Association may have a major impact not only on the Brazilian medical community but also on the health professionals engaged in the fight against tuberculosis, we would like this letter to be likewise published in the JBP. Some comments must be made about methodological issues that certainly influenced the conclusions of the aforementioned study.…”

“…Some comments must be made about methodological issues that certainly influenced the conclusions of the aforementioned study. 1 …”

“…In addition to the limitation that potential confounding factors were disregarded, there is the fact that the treatment was not implemented uniformly in Brazil, with implementation occurring early in some states and later in others. In the study by Rabahi et al, 1 the intervention time frame chosen does not seem appropriate, given that the study that validated the implementation of the supervised treatment in the health care system was completed only in September 2010, in five cities surveyed. 7 Therefore, during data analysis, line fitting should consider heterogeneity in the treatment’s adoption and use (whether treatment was supervised or not) and Family Health Program coverage by city, as well as socioeconomic variables.…”

“…The inferences drawn by the authors must also be considered, since not detecting a relationship between an exposure and an outcome should not be interpreted as “there is no relationship between them.” The study by Rabahi et al 1 could not detect the impact of the new treatment on cure and treatment abandonment rates, and it is not correct to state that “the changes in tuberculosis treatment were unable to contain the decrease in cure rates, the increase in treatment abandonment rates, (. .…”