This year marks the first year of monitoring progress towards TB elimination in the EU/EEA, as well as monitoring progress in implementing the eight areas of the Framework Action Plan to fight TB in the European Union. All four epidemiological indicators and five of the eight core indicators were analysed and a first view of how the EU/EEA is doing in terms of TB prevention and control is given.
As EU countries achieve a low TB notification rate of fewer than 20 cases per 100 000 population, there is the need to consolidate efforts to move towards the ultimate goal of eliminating TB. As case notification rates fall, monitoring the level of disease transmission within the country becomes more important. With a lack of reliable tests to measure transmission, surrogate markers are needed for monitoring purposes.
Progressing towards TB elimination in the EU/EEA and monitoring the framework action plan to fight TB in the EU
Epidemiological and Core Indicators
Epidemiological Indicators: tools which, assessed together, reflect both trends in disease burden and in the level of transmission.
- Trends in TB case notification rate
- Trends in MDR-TB case notification rate
- Trends in child-to-adult ratio of notification rates
- Trends in mean age of TB cases
- Core indicator 1: Availability of a national TB control plan
- Core indicator 2: Availability of guidelines for implementing the national TB control plan
- Core indicator 3: Percentage of National TB reference laboratories achieving adequate performance in the external quality assurance scheme
- Core indicator 4: Availability of a strategy for introducing and implementing new tools for TB control
- Core indicator 5: Percentage of new pulmonary TB cases confirmed by culture and percentage of new cases tested by DST for first-line drugs
- Core indicator 6: Percentage of Member States reporting treatment success rate
- Core indicator 7: Treatment success rate
- Core indicator 8: Percentage of TB patients for whom HIV-status is known
Trends in TB case notification rate
The 5-year trend in case notification rate, where the rate is defined as the number of all TB cases reported per year per 100 000 population
A mean declining trend in case notification rate over the previous five years allowing for annual random variation, in a context where case-finding efforts remained constant or increased.
- The overall notification rate in 2010 was 14.6 per 100 000 population.
- Over the last five reporting years (2006-2010), the EU/EEA has experienced a sustained annual decline of 4.4% in TB notification rates.
- The EU/EEA overall and 22 of the 29 reporting Member States met the target of a mean five-year decline.
- For the first time, all EU/EEA Member States have notification rates below 100 per 100 000 population and one country, Poland, has entered the elimination phase defined as <20 cases per 100 000.
- Stratifying between intermediate-to-high (≥ 20 per 100 000 population) and low-incidence (< 20 per 100 000 population) countries, the overall decline is attributable to that of the high-incidence Member States.
As TB notifications rates further decline it is essential that efforts are reinforced and maintained in Member States to ensure a continuation of the decrease in the number of cases, with a view to eventually eliminating TB in the EU/EEA.
Trends in MDR-TB case notification rate
The 5-year trend in MDR-TB case notification rate, where the rate is defined as the number of all TB cases reported per year per 100 000 population
A mean declining trend in MDR-TB case notification rate over the previous five years allowing for annual random variation, in a context where case-finding efforts remained constant or increased.
- The trends in TB case notification, MDR-TB case notification rates in the EU/EEA have remained stable over the last five years.
- A mean annual decline of 3.4% was measured for the period between 2006 and 2010.
- Seven countries reached the set target of a declining trend in MDR-TB case notification rates.
- The decline in MDR-TB notification rates is also attributable to the strong decline within high-incidence countries; especially over the last two reporting years (2009-2010).
- The decline can be attributed to strengthened and tailored TB control programmes targeting the MDR-TB epidemic in each of the high incidence countries with a decline in the number of MDR-TB cases.
Trends in child-to-adult ratio of notification rates
The 10-year trend in the ratio of the case notification rate in children under 15 years old to that in adults, i.e. change in the ratio.
A mean declining trend in the ratio of the notification rate in children to that in adults over the previous ten years, allowing for annual random variation.
During the period 2001-2010:
- Three countries observed a clear increase in the ratio of child-to-adult notification rates (18 countries in total with an increasing trend).
- One country observed a marked decline. A total of seven countries experienced a decreasing trend.
- The fall in the number of TB cases among children, reflected in a declining ratio, suggests a decrease in ongoing transmission in these countries. A decrease in transmission is in turn indicative that TB cases are rapidly identified and provided appropriate treatment, preventing further transmission in the setting.
Trends in mean age of TB cases
The trend in mean age of all TB cases, calculated either as crude mean age or population-standardised mean age.
An increasing trend in mean age of TB cases over the previous 10 years.
During the period 2001-2010:
- In ten Member States the mean age of TB increased.
- Thirteen Member States measured a decrease in the mean age between 2001 and 2010.
- An increasing trend is indicative that TB cases are mainly among the aging population (reflecting reactivation of disease). An effective TB control programme will prevent transmission by infectious cases to the surroundings and notification rates will drop. This will be especially seen in the younger population, control efforts having little effect on endogenous reactivation of disease, resulting in an increasing mean age.
The highly heterogeneous TB epidemiology in individual Member States makes it difficult to monitor trends in the child-to-adult ratio notification rate and the mean age of TB cases on the EU/EEA-level.
Overall for the EU/EEA, the changes in these two trends in the 10-year period, 2001-2010, are minimal (-0.3% and 0.0% respectively).
Core indicator 1: Availability of a national TB control plan
Availability of a national TB control plan which is in line with the areas and objectives of the Framework Action Plan to Fight TB in the EU and with international standards for TB control. The plan should have been formally adopted by the national government.
Member State: An up-to-date and endorsed national TB control plan is available.
EU: All Member States have an up-to-date and endorsed national TB control plan.
- In 2012 and 2013, ECDC aims to conduct a survey to map the availability of national TB control plans in Member States.
- A survey conducted by ECDC in 2009 provides an indication of the availability of national TB control plans and guidelines in countries. Sent to the EU/EEA Member States, fourteen of the 28 responding countries had an explicit national control plan for TB in 2009. Several other Member States did, however, have a detailed technical guidance for TB case management.
Core indicator 2: Availability of guidelines for implementing the national TB control plan
Availability of guidelines for the implementation of the TB control plan. Such guidelines should be in line with the areas and objectives of the Action Plan for the EU and with international standards for TB control. The guidelines should have been formally adopted by the national government.
Member State: Up-to-date and endorsed TB guidelines are available.
EU: All Member States have up-to-date and endorsed TB guidelines.
- In 2012 and 2013, ECDC aims to conduct a survey to map the availability of guidelines for the implementation of the TB control plan.
Strategic plans and monitoring platforms are essential to ensuring a consolidated and strategic approach to TB control and elimination. As EU and regional TB control ultimately relies on national efforts, the EU Action Plan requires the availability and implementation of national plans and implementation guidelines to ensure its effectiveness and impact.
Core indicator 3: Percentage of National TB reference laboratories achieving adequate performance in the external quality assurance scheme
The number of national TB reference laboratories (participating in the European Reference Laboratory Network for TB) achieving a cumulative performance score of 80% or above for quality assurance of smear microscopy, culture and Drug-susceptibility testing (DST) for first- and second-line drugs under the ERLN-TB external quality assurance (EQA) scheme.
100% of national TB reference laboratories participating in the ERLN-TB achieve a level of performance of 80% or above for smear microscopy, culture and DST for first- and second-line drugs.
- The European Reference Laboratory Network for TB (ERLN-TB) coordinates and runs external quality assurance (EQA) schemes for proficiency testing in smear microscopy, culture and drug-susceptibility test (DST) for first- and second-line anti-TB drugs.
- Since 2010, three rounds of EQA have been performed and results are currently being collated.
- First indications are that performance is good in all diagnostic methods at the majority of reference laboratories, and it can therefore be concluded that TB reference laboratories offer quality diagnostic services.
- Twenty-three national reference laboratories reported on performance in DST for first-line anti-TB drugs following the international EQA schemes of the WHO Supra-National Reference Laboratory Network. All 23 laboratories reported full agreement of results, demonstrating high-quality DST, according to the SNRL-Network schemes.
- This indicates that the reference laboratories are providing reliable drug-resistance diagnosis which is essential to ensure optimal TB care and control in Member States.
Strong, quality-assured reference laboratories in Member States play a key role in supporting regional and local TB laboratories in the performance of high-quality TB diagnostics.
Core indicator 4: Availability of a strategy for introducing and implementing new tools for TB control
- In 2012 and 2013, together with a survey on national TB control plans and implementation guidelines, ECDC aims to map the availability of strategies for introducing and implementing new tools for TB in Member States.
As new tools become available for TB diagnosis, treatment and prevention, it is essential that they are introduced and implemented properly, and only in algorithms where they have proven efficacy and effectiveness.
Core indicator 5: Percentage of new pulmonary TB cases confirmed by culture and percentage of new cases tested by DST for first-line drugs
Percentage of new pulmonary TB cases that are confirmed by culture and identified as the M. tuberculosis Complex (MTC) and the percentage of cases for which DST for first-line drugs has been performed.
Member State: 80% of all new pulmonary TB cases are culture-confirmed. 100% of the culture-confirmed cases should be tested by DST for first-line drugs.
EU: 80% of all new pulmonary TB cases in the EU are culture-confirmed. 100% of the culture-confirmed should be tested by DST for first-line drugs.
- In 2010, 12 (41%) of 29 EU/EEA countries achieved 80% or more culture-confirmation among new pulmonary TB cases.
- This is almost a doubling in the number of countries reaching the target compared to 2009 (7/29, 24%) and indicates a strengthened ability in several Member States to correctly confirm active cases, which is the first step to providing drug-susceptibility testing of culture-confirmed cases to detect drug-resistance.
- However, the overall proportion of culture-confirmed new pulmonary TB cases remains low in the EU/EEA, measuring only 65.6% in 2010 and indicating sub-optimal diagnosis of new pulmonary TB cases.
- Drug-susceptibility testing (DST) results were reported for 70.8% of the culture-confirmed new pulmonary TB cases in the EU/EEA.
- Only eight countries reached the target of testing 100% of all new culture-positive pulmonary TB cases for drug-resistance to first-line drugs. However, several countries are very close to the target, with 12 countries securing DST for over 90% of cases.
- DST of new culture-confirmed pulmonary TB cases remains substantially below the target, indicating that the identification of MDR-TB cases is still compromised.
- It remains to be determined whether the low culture-confirmation in the EU/EEA is the result of sub-optimal diagnostic practices or poor linkage of laboratory and epidemiological data.
From a programmatic perspective, reaching a culture confirmation target (80%) and testing 100% of these cases for susceptibility to first-line drugs is of key importance in assuring correct TB diagnosis of new cases and the subsequent rapid detection and treatment of M/XDR-TB cases.
Core indicator 6: Percentage of Member States reporting treatment success rate
Percentage of Member States submitting reports of treatment success rate to the ECDC on an annual basis.
All Member States (100%) report treatment outcome monitoring for all TB cases to ECDC.
- Twenty-four (82.8%) Member States reported treatment outcome monitoring (TOM) data for all TB cases diagnosed in 2009.
- This indicates that five EU/EEA Member States still need to optimise their reporting and recording systems to enable full monitoring of TB treatment outcome.
Optimal treatment outcome-monitoring (TOM) and a high proportion of successfully treated patients are strong indicators for assessing programmatic performance. Achieving high performance will both have an impact on the epidemic and prevent the emergence of drug-resistance.
Core indicator 7: Treatment success rate
The proportion of new pulmonary culture-positive TB cases in a given year that successfully completed treatment, either with bacteriological evidence of success (cured) or without (treatment completed). The numerator is the number of new pulmonary culture-positive TB cases registered in the year that were cured plus the number of those who completed treatment. The denominator is the total number of new pulmonary culture-positive TB cases registered in the same year.
This indicator should also be calculated for MDR cases, in which case the treatment outcome should be measured after 24 months. Only confirmed MDR TB cases should be included in an MDR cohort.
Member State: Treatment success of 85% at 12 months for the complete cohort of new pulmonary culture-positive cases.
EU: Treatment success of 85% at 12 months for the complete cohort of new pulmonary culture-positive cases.
Member State: Treatment success of 70% at 24 months for new pulmonary culture-positive pulmonary MDR cases.
EU: Treatment success of 70% at 24 months for new pulmonary culture-positive pulmonary MDR cases.
Overall, for the 24 EU/EEA Member States reporting treatment outcome of TB cases reported in 2009:
- 78.8% of new pulmonary culture-confirmed TB cases had a successful treatment outcome.
- Five countries reached the 85% target.
For MDR-TB cases reported in 2008, among the 21 EU/EEA Member States reporting at least one new culture-confirmed pulmonary MDR-TB cases:
- Only 16 Member States reported on treatment outcome.
- This presents a large caveat in understanding treatment outcome among MDR-TB cases in the EU/EEA, and subsequently hampers the identification of strengths and challenges in MDR-TB control and prevents targeted intervention and support.
Overall for the 16 EU/EEA Member States reporting treatment outcome of new culture-confirmed pulmonary MDR-TB cases reported in 2008:
- 49% had a successful outcome; remaining far below the 70% target.
- Only four countries reached the 70% target.
- This poses a serious threat to patient survival and risks the development of XDR-TB.
Continued efforts and targeted support are needed to improve the reporting of TOM data by Member States and to ensure successful treatment of new culture-confirmed TB cases as well as MDR-TB cases.
Core indicator 8: Percentage of TB patients for whom HIV-status is known
The proportion of all TB patients for which the HIV status is known.
Member State: HIV status is known for 100% of notified TB cases.
EU: HIV-status is known for 100% of TB cases.
- In 2010, 15 Member States provided data on HIV status. Only one Member States reported known HIV-status for all TB cases. Two countries reported the known status for more than 95% of TB cases.
- The low level of reporting HIV-infection among TB cases, as well as the low-coverage of HIV-testing for the 15 reporting countries, may indicate that national TB programmes are lacking targeted, incorporated TB/HIV plans.
- As described in the Follow-up to the Action Plan however, a limitation of this indicator is that it does not directly assess whether systems are in place within countries to provide HIV-infected TB patients with adequate treatment, management and follow-up, regardless of reporting practices.
To combat TB among individuals with HIV infection, it is essential to integrate TB and HIV treatment programmes given the challenges in treating this TB patient group. A clear overview of the extent of HIV infection among TB patients is lacking in the EU/EEA, due to the sub-optimal reporting of HIV prevalence in countries. This is mainly due to differences in testing policies and data collection within countries.