One of the key factors in the proper control of tuberculosis (TB), aside from early detection and careful case management, is the availability of specialized staff and good coordination between the various levels. Good control requires not only medical experts, but also adequate numbers of specialized nursing staff, and well-structured and properly organized departments managed by experienced personnel.1–4 In countries where the incidence of TB is low, such as Spain, which has many more primary care physicians (PCPs) than TB patients, TB care and contact tracing should be centralized in specialized units.5 The framework document for the elimination of TB in low-incidence countries stresses the importance of a central coordination team, specialized units for the diagnosis and treatment of TB, and the appropriate level of centralization.5

In their efforts to improve TB control, the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) has promoted the accreditation of tuberculosis units (TBU) dedicated to the treatment, monitoring and prevention of the disease. Although the number of cases has fallen significantly, TB continues to be of clinical importance. It is often difficult to manage, and treatment can be complicated by the presence of forms that are resistant to the most effective drugs. As such, in addition to basic units, we also need expert, specialized units that can advise and manage complex treatments, perform contact tracing, and coordinate with other specialties or levels of care. One of the aims of SEPAR is to support the creation and subsequent accreditation of functional, multidisciplinary TBUs, seeking to unite specialties, professionals, and official bodies involved in the management of this disease.6,7

Awareness of which specialists are responsible for diagnosis, treatment, and contact tracing in patients with pulmonary and extrapulmonary TB and the coordination among the various healthcare strata could help design strategies that will improve the organization of TBUs. This would be an important step forward in the control of TB in Spain.

The aim of this study, therefore, was to characterize the organization of pulmonology departments and professionals working in TB control in Spain before and after the accreditation of TBUs by SEPAR, and to analyze the effectiveness of this initiative.

Of the 139 pulmonology departments or sections contacted in Spain, 76 (54.7%) completed the pre-accreditation questionnaire administered between 2014 and 2016, and 60 (43.2%) completed the post-accreditation questionnaire between 2017 and 2018. A total of 93 centers completed at least one questionnaire, and 43 completed both.

The 76 pre-accreditation questionnaires came from 16/17 (94.1%) autonomous communities and 33/50 (66%) provinces of Spain. A total of 90.8% (69/76) were completed by pulmonology departments or sections, and 7/76 (9.2%) by internal medicine or infectious diseases departments; 42.1% (32) and 52.6% (40) belonged to hospitals with more than 500 and 100–500 beds, respectively. The overall median of TB cases in 2014, 2015 and 2016 was 28 (IQR: 10.5–52.5) per center, and 84.2% (64) recorded the final outcome of treatment. Pulmonary TB was treated by pulmonologists (59.2%) in most sites, while extrapulmonary TB was treated by internal medicine in 57.9% of the hospitals. Contact registries were performed in 72.4% of sites (55), and 60.5% were involved in contact tracing. In 64.5% of sites (49), there was a TB medical coordinator, 63.2% (48) coordinated with PC, and 61.8% (47) coordinated with higher levels of care. A total of 34.2% (26) were already organized as TBUs, 42.1% (32) had a nurse case manager, and 94.7% (72) reported more than 75% of cases to the public health authorities.

In terms of geographical distribution, the 60 pre-accreditation questionnaires came from 15/17 (88.2%) autonomous communities and 26/50 (52%) provinces of Spain. A total of 86.7% (52/60) were completed by pulmonology departments or sections, and 8/60 (13.3%) by internal medicine or infectious diseases departments; 45.0% (27) and 50.0% (30) belonged to hospitals with more than 500 and 100–500 beds, respectively. The median of TB cases in 2017 and 2018 was 20 (IQR: 14.5–45.5) per site, and 86.7% (52) recorded the final outcome of treatment. Contact registries were kept in 68.3% of centers (41) and 61.7% performed contact tracing. In 68.3% of sites (41), there was a TB medical coordinator, 73.3% (44) coordinated with PC, and 63.3% (38) coordinated with higher levels of care. A total of 36.7% (22) were already organized as TBUs, 46.7% (28) had a nurse case manager, and 91.7% (55) reported more than 75% of cases to the public health authorities. Of the 40 non-accredited centers, 21 (52.5%) stated that they would like to be accredited as TBUs.

Table 1 compares the main variables collected from the questionnaire before and after accreditation. No significant changes were found in the different care and coordination settings between the pre- and post-accreditation, although an improvement was noted in the recording of final conclusions.

Of all the sites that responded to the survey, 20 were accredited as TBUs, and 15 of these sites completed both questionnaires. When the results of the questionnaire before and after TBU accreditation in these 15 sites were compared, no differences were observed in the organization before and after accreditation (Table 2).

The comparison of the 20 accredited sites with the 73 non-accredited sites show statistically significant differences. A higher percentage of the accredited sites record the final outcome of cases, coordinate with PC, have a TB medical coordinator, and use referral circuits to send patients to other more complex departments. A greater proportion of these sites also manage patients with multiresistant or extremely resistant TB, have the capacity to facilitate DOT on-site or in other centers, perform contact tracing, and have a TB nurse case manager. Accredited sites are located in only 9 autonomous communities and most of these sites already had a TBU, and participated by contributing cases to the PII-TB registry (Table 3).

When the 20 accredited sites were compared with the 73 unaccredited sites, the logistic regression model indicates that the variables associated with TBU accreditation were constituting a TBU (ORa=22.68; 95% CI: 3.84–133.74; p=0.001) and availability of referral circuits to other more complex departments (ORa=8.53; 95% CI: 1.12–64.80; p=0.038) (Table 3).

This study has helped us understand how TB is managed in pulmonology departments and sections and by other professionals involved in the treatment of this disease in Spain. It has also helped characterize the differences between accredited and non-accredited sites. According to survey respondents, pulmonary TB is managed, above all, by pulmonologists, and extrapulmonary TB is managed by internists. In a high proportion of sites, cases are followed up until treatment completion, resistance and comorbidities are managed, and DOT is offered to patients. However, contact registries and tracing should be improved in pulmonology and preventive medicine departments, and, while the percentage of cases reported to the public health authorities is high, sites were identified in which reporting is less than 75%, despite TB being a notifiable disease.

The results obtained from self-administered questionnaires reveal no significant differences between the different care and coordination variables among sites that completed the pre- and post-accreditation questionnaire. Moreover, accredited sites that completed both questionnaires (N=15) also showed no organizational differences before and after accreditation. Finally, when the accredited sites were compared with the non-accredited sites, statistically significant differences were observed in organizational and patient care variables. The multivariate analysis indicates that constituting a TBU and having referral circuits to other more complex departments are associated with accreditation as a TBU.

The lack of significant improvements observed in SEPAR accredited sites before and after accreditation could be attributed to the fact that those sites were already managing TB effectively and correctly before applying for accreditation. Moreover, our sample size is small and has low statistical power. However, differences were found between accredited and non-accredited sites, and this could be due to the fact that accredited sites already have better organization and better indicators. Accreditation involves reviewing and implementing actions to improve disease management and control, and evaluating and reorganizing staff and their activities.

As study limitations, we must mention that it was impossible to verify the responses, and that the post-accreditation questionnaires were administered only 2 years after initiating the accreditation process. More time may be needed to increase the number of accredited TBUs and assess their progress. In any case, accreditation of TBUs could encourage other units to seek accreditation. The management and treatment of immunocompromised patients (biological treatments, elderly individuals, etc.) in TBUs could be evaluated in greater depth in the questionnaires, since this is a particularly vulnerable population.

There is evidence that in large cities in countries with a low incidence of TB, the efficiency of control programs can be increased with organizational improvements.1,4 With regard to outcomes, other authors have also associated better TB control with improved organization based on the creation of TBUs. More specifically, a study conducted to assess the impact of setting up a TBU in Barcelona concluded that this intervention improved contact tracing.3 This is similar to the findings of our study when accredited sites were compared with non-accredited sites. Comparable results were observed in the Galician TB Program, organized around 7 TBUs.12 The key points for organizing TB management highlighted by all these studies were the centralization of TB care, the role of nurse case managers, and coordination and communication between the different areas and professionals involved.1,3 Accredited units presented better indicators than non-accredited units in all of these areas.

The Autonomous Community of Madrid carried out an evaluation of TB control and found high rates of cases lost to follow-up and a low rate of contact tracing. The authors underlined the need to centralize the follow-up of patients and contact tracing in the TBU to improve outcomes.13 Other publications recommend that, because the low incidence prevents PCPs from accumulating experience, TB care must be centralized, with constant communication between coordinated groups of specialized professionals.5,14–16

A study conducted in the United Kingdom concluded that good disease control depends on the availability of an appropriate number of TB specialists. One TB control strategy was the availability of 1 dedicated TB nurse for every 40 patients.2 Our study does not permit adequate comparisons, but the percentage of sites with TB nurse case managers and TB medical coordinators was much higher among accredited units.

Along the same lines, the consensus on TB control in large cities produced by a working group representing several large cities in the European Union stresses the importance of organizing the center to ensure patient access, incorporating sufficient experienced personnel, and promoting strong collaboration and coordination between sectors.4

A systematic review on interventions that improve adherence and TB treatment outcomes concluded that the administration of DOT and patient education increase therapeutic adherence and success rates.17

It is important to note that, although TB is a notifiable disease, underreporting of cases to the public health authorities has been observed in some sites in Spain, thus complicating disease control. A study by Gimenez-Duran et al. revealed underreporting in the Balearic Islands from anti-tuberculosis drug prescriptions,18 and another by Morales-Garcia et al. observed significant underreporting in 16 Spanish hospitals, and stressed that sites that had a nurse case manager had reporting rates of 100%,19 reinforing the importance of this figure in the TBU.

According to a study conducted in California, implementing systematic annual assessment and indicator-based improvement processes in TB control programs improved outcomes.20 This would support the adoption of indicators as tools for improving outcomes in accredited sites. A questionnaire administered to 31 countries in the EU and European Economic Area to determine TB control strategies identified a number of priority actions: reaching vulnerable population groups, actively detecting TB in high-risk groups, implementating electronic records and contact tracing, controlling multidrug-resistant TB, and centralizing care.21

All of the above-mentioned studies support the use of organizational indicators, such as appointing a nurse case manager, performing contact tracing, administering appropriate treatment, administering DOT, and coordinating with other departments and professionals.22,23 TB unit accreditation is a SEPAR initiative that gives a quality seal of approval to units that meet a series of objective criteria based on indicators used in previous studies.6 Moreover, the creation of a TBU can help achieve the goals of the World Health Organization End TB strategy.24

Although several positive aspects have been detected, such as recording final outcomes, notifying public health authorities, managing resistance, and controlling associated or iatrogenic diseases, there were also several areas for improvement. The latter include appointing a TB medical coordinator, organizing contact registries and tracing, creating referral and coordination circuits, and appointing nurse case managers. This last recommendation is paramount for the management of TB, and is one of the most important improvements noted in accredited TBUs. The significant differences in results and operation between accredited and non-accredited units should compel the latter units to improve their organization and try to meet the criteria required for accreditation.

This study sheds light on the current organization of TB management and control in Spain and on the impact of SEPAR TBU accreditation.

TBUs must be closely supervised using simple annual indicators that can even be used to facilitate self-assessment. The progressive improvement of the effectiveness of the TBUs, along with an equally progressive increase in accreditations, whether for new applications or in response to an increase in the level of complexity and re-accreditations, would contribute to the improvement of the organization of TB control in Spain.

This study was funded by a grant from the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR 114/2013) (PI: Joan Pau Millet), Spain.

The authors state that they have no conflict of interests.