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Estimates of the burden of disease caused by TB and

phasing out the publication of estimates of the


case detection rate (CDR) for smear-positive TB:
Answers to Frequently Asked Questions
For the first time since WHO began publishing annual reports on global TB
control in 1997, the 2010 report does not include estimates of the case detection
rate (CDR) for smear-positive TB. The CDR for smear-positive TB is the total
number of new cases of smear-positive TB notified in a given year, divided by
the estimated incidence of smear-positive TB in the same year.
This Question and Answer sheet provides answers to the most frequently-asked
questions on this topic, as well as related questions about estimates of the
burden of disease caused by TB. For questions not addressed on this sheet,
please contact your WHO regional or country office, or send your question to
tbdata@who.int.

Q1. Why has WHO stopped publishing estimates of the CDR for smear-positive TB?

There are several reasons. The major ones are as follows:


• The CDR for smear-positive TB cannot be directly measured and there is major
uncertainty about its true value in most countries (since the denominator, the incidence
of smear-positive TB, cannot be directly measured). When the CDR for smear-positive
TB was one of the two major global targets used to assess progress in TB control (i.e.
up to 2005), and when national TB programmes were starting to implement the DOTS
strategy in the mid-1990s which gave particular emphasis to smear-positive cases, an
effort to estimate it was justified. This situation no longer applies.
• Since 2006, the framework of international targets for TB care and control has not
included a target for the CDR for smear-positive TB. The targets set for 2015 focus on
reductions in the burden of disease caused by TB i.e. that incidence should be falling
in 2015 (MDG target 6.c) and that prevalence and deaths should be halved compared
with their level in 1990 (targets set by the Stop TB Partnership).
• Since the launch of WHO's Stop TB Strategy in 2006, the detection and treatment of
all forms of TB has been emphasized.
• New diagnostics (such as new molecular tests) that allow a definite diagnosis of
people with smear-negative TB as well as the expansion of culture make a focus on
the detection of only smear-positive cases increasingly outdated.
• A continued focus on estimates of the CDR for smear-positive TB risks distracting
attention from a focus on reducing the burden of disease caused by TB in line with
targets set for 2015. An overemphasis on the sm+ CDR has already been associated
with lack of recognition of major progress in reducing the burden of disease caused by
TB in some countries.
• Estimates must stand up to scientific scrutiny. Since 2008, it has been clearly
recognized that estimating the CDR for smear-positive TB is problematic, and more
problematic than estimating the CDR for all forms of TB (see also Q2).
Q2. Why are estimates of the CDR for all forms of TB still being published?

The CDR for all forms of TB is an MDG indicator (indicator 6.10). Furthermore, for most
countries, estimates of the total number of incident cases of TB are based on estimates of the
CDR for all forms of TB (full details are provided in Annex 1 of the 2010 WHO report on
global TB control). Plausible ranges for estimates of the all-forms CDR are developed during
consultations with countries, in which a framework for assessment of the quality and coverage
of surveillance data that has been developed by the WHO Global Task Force on TB Impact
Measurement is applied, results discussed and conclusions agreed upon. Once estimates of TB
incidence are published alongside data on total notifications, it is informative to present
estimates of the fraction of all incident cases that are being detected (and notified), along with
their documented uncertainty.

Although the CDR for all forms of TB is difficult to estimate, it remains less problematic than
estimates of the CDR for smear-positive TB. This is because estimates of the CDR for smear-
positive TB require an additional assumption about the proportion of all incident cases that
have smear-positive TB. A recent systematic review has shown that there is major uncertainty
about the proportion of incident cases that have smear-positive TB (the proportion ranges
from around 30–70%).

Q3. If the 70% CDR target for smear-positive TB no longer applies, what is the CDR
target for all forms of TB - for example linked to the concept of universal access to
treatment?

There is no global target for the CDR for all forms of TB. The international targets for TB
control are that incidence should be falling by 2015 and that prevalence and mortality should
be halved by 2015 compared with their level in 1990.

WHO does not recommend that countries set specific targets for the CDR for all forms of TB
because the CDR is not directly measureable and there is thus considerable uncertainty about
its true value.

The Stop TB Partnership's Global Plan to Stop TB 2011–2015 includes several indicators and
targets that fit well with the concept of universal access, and which can be easily and directly
measured by national TB programmes. These include targets for 2015 of testing all TB
patients for HIV, enrolling all HIV-positive TB patients on antiretroviral treatment, testing all
previously treated cases for multidrug-resistant TB (MDR-TB) and ensuring that diagnosis
and treatment are free-of-charge or fully reimbursable via health insurance. There is, however,
no target for the CDR, given the difficulties of measuring this indicator with precision.

WHO plans to convene a Task Force in 2011 to discuss targets related to universal access,
linked also to the establishment of global targets for TB control beyond 2015.

Q4. How reliable are estimates of the CDR?

WHO publishes estimates of the CDR with uncertainty intervals. These uncertainty intervals
provide the range of most plausible values for the CDR. Best estimates of the CDR should
only be used after carefully accounting for their uncertainty.

Q5. How frequently will the CDR for all forms of TB be reassessed?

Estimates will be updated once per year, at most. This will be done in consultation with
national TB programmes.
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Q6. How can estimates of the CDR be improved?

The WHO Global Task Force on TB Impact Measurement has developed a framework for
systematic assessment of the quality and coverage of surveillance data (notification data to
measure cases, vital registration data to measure TB deaths). This framework and associated
tools are designed 1) to enable a systematic review and updating of estimates of the burden of
disease caused by TB and the case detection rate (for all forms of TB), based on full use of the
available data and, where insufficient data exist, expert opinion and 2) to identify ways in
which surveillance systems need to be strengthened towards the ultimate goal of directly
measuring cases and deaths from notification and vital registration systems. Between April
2008 and the end of 2010, the framework and associated tools were used in regional
workshops and country missions covering a total of 87 countries.

Specific approaches to improve estimates of the CDR include "inventory" studies (these allow
for quantification of cases being diagnosed but not notified in the public and private sectors)
and better use of mortality data from vital registration (VR) systems (which can be used to
cross-validate estimates of TB incidence and also provide a better understanding of the
number of cases that are never reported). There are now excellent examples of the value of
inventory studies from several countries in the Eastern Mediterranean region, and cross-
linkage of notification and VR databases has been used in Brazil and the United Kingdom.
Population-based surveys of the prevalence of TB disease can also provide very useful
information about why and to what extent people with TB are missed in surveillance data.

Q7. Should targets for the CDR be included in plans for TB control?

The CDR for all forms of TB should not be used for planning purposes.

This is because estimates are uncertain and because updates to time-series of incidence
estimates can result in baselines and targets becoming meaningless. This has been a common
problem in grant agreements signed with the Global Fund, since the CDR was often included
as an indicator for which targets were set in proposals to the Global Fund (see also Q8).

Plans for TB control need to include projections of the number of patients that will be
diagnosed and treated, since these projections are needed to set realistic budgets. Projections
of the number of patients to be treated can be based on recent trends in notifications and an
assessment of the likely impact of new interventions (e.g. new diagnostics) on case-finding
and case-reporting.

Q8. What are the implications for monitoring and evaluation, especially in the context of
Global Fund grants?

There have been multiple problems with CDR targets set in grant agreements signed with the
Global Fund. In recognition of these problems and following consultations with WHO, the
Global Fund removed the CDR as an indicator for which targets should be set from its
performance framework in October 2010. The CDR has been replaced by the case notification
rate, which can be directly measured and reported by all national TB programmes. If an
ongoing grant agreement requires reporting of the CDR for smear-positive TB, the CDR for
all forms may be reported instead. If this results in an apparent drop in the CDR, the country
will not be penalized.

The Stop TB Partnership's Global Plan to Stop TB 2011–2015 includes several indicators and
targets that that can be easily and directly measured by national TB programmes, and used to
monitor and evaluate progress in the context of Global Fund grants.
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Q9. What is the relationship between the CDR for all forms of TB and the CDR for
smear-positive TB?

It is very difficult to predict the proportion of smear-positive TB among all incident cases of
TB. There is no fixed and well established relationship between the CDR for all forms of TB
and the CDR for smear-positive TB.

Q10. If there are concerns about estimates of the CDR for all forms of TB published in
WHO reports, what can be done?

The TB monitoring and evaluation team in WHO-HQ aims to publish estimates based on full
consultation with countries. In a series of regional workshops held in all WHO regions
between April 2008 and December 2010, estimates were reviewed and updated in
consultation with 87 countries, using a framework and associated tools developed by the
WHO Global Task Force on TB Impact Measurement (see also Q6 and Q14). Countries that
would like a review and updating of estimates should contact their WHO country or regional
office.

Q11. What will happen with the treatment success rate?

Treatment success is a very important indicator of the quality of TB care, and can be directly
measured. Monitoring of the treatment success rate will continue. The global target for 2015
included in the Global Plan to Stop TB 2011–2015 is 90%.

Q12. How is TB incidence estimated?

In countries with high-quality TB surveillance systems and well-performing health systems,


almost all incident TB cases are rapidly diagnosed and documented through mandatory
notification, such that notifications can be considered a proxy for incidence.

In all other countries, surveillance systems do not capture all incident cases in a timely
manner. For instance, reporting of new TB cases may not be complete because there is no
mandatory reporting from the private sector. Furthermore, incidence cannot be measured
directly through a population-based survey because such a survey would require enormous
resources: no country has ever been able to conduct a nationally representative survey of TB
incidence. It should also be emphasized that the incidence of TB disease cannot be estimated
reliably using results from tuberculin surveys of the annual risk of infection, because there is
no fixed relationship between the prevalence of infection as determined by the tuberculin test
and the incidence of TB disease. In addition, incidence cannot be derived reliably from
measurements of prevalence obtained from population-based surveys, because there is no
practical way to accurately determine the average duration of disease.

As a result, incidence has to be estimated indirectly, using notification data, data on the
performance of TB programmes and, more widely, information about the health systems
within which they operate (see also Q6). The indirect estimation of incidence is imprecise, as
reflected in the uncertainty intervals published by WHO.

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Q13. How accurate are the estimates for incidence, prevalence and mortality that are
included in the global reports published by WHO?

All estimates of disease burden published in WHO reports on global TB control are presented
as best estimates with uncertainty intervals. The uncertainty intervals provide a range of
plausible values; the narrower the uncertainty interval, the more accurate the estimate.

Estimates of TB incidence are most precise when notification data can be used as a close
proxy of total incidence. Estimates of TB mortality are most precise when they are based on
death registrations recorded in vital registration systems with high quality and coverage (VR
data were used to estimate mortality in 89 countries in the 2010 report). Estimates of TB
prevalence are most accurate when they are based on direct measurements from national
population-based surveys of the prevalence of TB disease.

Q14. What is being done to make estimates of the burden of disease caused by TB more
accurate?

The Tuberculosis Monitoring and Evaluation team in WHO-HQ has convened a Global Task
Force on TB Impact Measurement since 2006. This Task Force has a mandate to ensure the
best possible measurement of the burden of disease caused by TB and trends in this burden, as
well as building capacity in monitoring and evaluation at country level. The Task Force has
defined three strategic tracks of work, which include prevalence surveys in at least 21 global
focus countries, strengthening surveillance (of cases via notification systems and of mortality
via vital registration systems) in all countries, and periodic review and updating of the
methods used to translate surveillance and survey data into estimates of TB incidence,
prevalence and mortality. Full details have been set out in a WHO Policy Paper (reference 1
below). Between mid-2007 and the end of 2010, progress included the following:
• Application of the Task Force framework for assessing the quality and coverage of
surveillance data, and associated updating of estimates of disease burden and
development of plans for how surveillance needs to be strengthened, in regional
workshops and country missions covering 87 countries.
• Major progress in the design, planning and implementation of prevalence surveys in
around 20 countries.
• Much greater use of data from vital registration (VR) systems to produce estimates of
TB mortality. Such data were used to estimate TB mortality for 89 countries in 2010,
compared with three in 2008.
• An 18-month expert review of methods used to translate surveillance and survey data
into estimates of disease burden, and consensus about associated updates and
improvements to methods, completed in October 2009.

Besides the WHO Task Force, estimates of the burden of disease caused by TB have been
reviewed by experts collaborating on the Global Burden of Disease project (led by the
Institute of Health Metrics and Evaluation at the University of Washington, Seattle, USA).

For further information

1. World Health Organization, 2009. TB Impact Measurement: Policy and


recommendations for how to assess the epidemiological burden of TB and the impact of
TB control. Stop TB policy paper; no 2. WHO/HTM/TB/2009.416.

2. www.who.int/tb/advisory_bodies/impact_measurement_taskforce

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