The understanding of the process of adoption of any new health technology becomes highly important for tuberculosis services as new diagnostic tests [15], treatment regimens [16] and vaccines [17] are expected to emerge in the next few years, after decades of stagnation. How to evaluate these processes, however, is a challenge. Habicht et al. (1999) [18] revised the design options to evaluate public health program performance. They enumerate, as indicators of performance: adequacy, provision, utilization, coverage and impact. The authors also point out that specific interventions should be evaluated considering the initially planned implementation schedule. In the present study, we chose to analyze the time till full coverage of the implementation of a new treatment recommendation in different municipalities in Brazil using secondary data. This was only possible because notification of tuberculosis is mandatory in the country.
Elmahalli et al. (2010) [19] assessed the implementation of DOTS strategy in two chest facilities in Alexandria, Egypt, using treatment success as the outcome. They argue that operational indicators, such as treatment outcome, can be considered excellent tools for monitoring the process of tuberculosis care, especially in developing countries. Although we agree that these are useful indicators of program performance, they are less appropriate to study the implementation process of a new recommendation. In our study, we preferred, instead, to study the implementation process of the new treatment regimen using a different approach, since other relevant data were available in the Brazilian surveillance system.
The implementation of new tuberculosis treatments, including MDR-TB treatment, was reported in different countries [20]. However, these analyses were essentially descriptive. To our knowledge, there are no previous studies addressing factors associated with the implementation process measured as the time to reach full coverage. In the present study, we addressed the factors associated with the time to full coverage of new regimen implementation process. Almost 70% of Brazilian municipalities had notified at least one case of tuberculosis in the study period, which reflects on one hand, the extent of the disease in the country and on the other hand, the expansion of tuberculosis diagnostic activities. Demographic and epidemiological factors as well as operational factors influenced rapid implementation. Among them, demographic factors had the higher magnitude of association. Municipalities characteristics such as population size, demographic density and incidence rates were associated with the rapid implementation of the new regimen. Although in a smaller magnitude, compliance to some NTCP recommendations, such as DOT and microbiological confirmation of cases, also were associated with rapid implementation.
Larger municipalities generally have health systems with many facilities, which need more human resources and health infrastructure, more complex public health program management. They also have populations with a high heterogeneity concerning access to diagnosis and tuberculosis treatment services, which may explain the more rapid implementation in smaller municipalities. This explanation is corroborated by a recent study in Recife, a large city in the Northeast of Brazil, where the incomplete implementation of the epidemiological surveillance management was explained by lack of human resources and incipient performance of planning and Monitoring & Evaluation activities [21]. Likewise, the Family Health Program implementation in Santa Catarina, a wealthy and developed state in Southern Brazil, was firstly implanted in areas less assisted, in small or medium size municipalities, where financial incentive to the program induced rapid implementation. Indeed, one or two family health teams offers high coverage rates in municipalities with up to 10,000 inhabitants [22].
Regardless of the population size, demographic density also delayed the implementation of the new treatment. Poor social condition found in situations of intense urban agglomerations possibly hamper access to health services. It is intuitive to expect that municipalities with small populations or a small number of cases have easier access to new regimens. Areas with large number of cases demand more health units and higher number of trained professionals. On the other hand, higher incidence rates are usually found in situations of worse health policy performance. Lack of professionals, transport problems and insufficient resources for technical assistance were considered the major barriers for tuberculosis control in São José do Rio Preto, a medium size municipality [22].
In the present study, operational indicators such as DOT coverage and microbiological confirmation of diagnosis, as recommended by the NTCP guidelines, were independently associated to rapid implementation of the new regimen. This may reflect willingness, commitment and capacity of municipal TCP in lining-up with new recommendations from the NTCP. None of those different operational aspects represent by themselves a construct regarding the quality of tuberculosis control actions practiced at the municipal level. However, the independent association of those factors indicates that they evaluate different aspects of the same commitment.
Other factors possibly associated with rapid implementation of the new regimen, mainly those related to health service organization (human resources, decentralization of care, municipal tuberculosis control program structure among others), were not considered due to the nature of this study, which used secondary data from the tuberculosis surveillance system. The quality of this database may have influenced the results of this study. Thus, a previous evaluation was done to ensure the quality of the data [7]. Other possible limitations of this study may result from classification of individuals regarding the use of the new regimen, which was based on the use of 4 drugs in new cases, instead of the use of FDCs, since the latter information is not available. This may have overestimated the coverage of the new regimen, but is not likely to have influenced the evaluation of the implementation speed.