Rationale

Although in the past decade there has been substantial progress in the development
and implementation of the strategies necessary for effective tuberculosis control, the disease
remains an enormous and growing global health problem.6–9 One-third of the world’s
population is infected with M. tuberculosis, mostly in developing countries, where 95% of
cases occur.8 In 2003, there were an estimated 8.8 million new cases of tuberculosis, of
which 3.9 million were sputum smear-positive and, thus, highly infectious.6,7 The number
of tuberculosis cases that occur in the world each year is still growing, although the rate of
increase is slowing. In the African region of the WHO, the tuberculosis case rate continues
to increase, both because of the epidemic of HIV infection in sub-Saharan countries and
the poor or absent primary care services in parts of the region.6,7 In Eastern Europe, after
a decade of increases, case rates have only recently reached a plateau, the increases
being attributed to the collapse of the public health infrastructure, increased poverty, and
other socio-economic factors complicated further by the high prevalence of drug-resistant
tuberculosis.6,7,9 In many other countries, because of incomplete application of effective
care and control measures, tuberculosis case rates are either stagnant or decreasing
more slowly than should be expected. This is especially true in high-risk groups such as
persons with HIV infection, the homeless, prisoners, and recent immigrants. The failure to
bring about a more rapid reduction in tuberculosis incidence, at least in part, relates to a
failure to fully engage non-tuberculosis control program providers in the provision of highquality
care, in coordination with local and national control programs.

It is widely recognized that many providers are involved in the diagnosis and treatment
of tuberculosis.10-13 Traditional healers, general and specialist physicians, nurses, clinical
officers, academic physicians, unlicensed practitioners, physicians in private practice,
practitioners of alternative medicine, and community organizations, among others, all play
roles in tuberculosis care and, therefore, in tuberculosis control. In addition, other public
providers, such as those working in prisons, army hospitals, or public hospitals and facilities,
regularly evaluate persons suspected of having tuberculosis and treat patients who
have the disease.

Little is known about the adequacy of care delivered by non-program providers, but evidence
from studies conducted in many different parts of the world show great variability
in the quality of tuberculosis care, and poor quality care continues to plague global tuberculosis
control efforts.11 A recent global situation assessment reported by WHO suggested
that delays in diagnosis were common.12 The delay was more often in receiving a
diagnosis rather than in seeking care, although both elements are important.14 This survey
and other studies also show that clinicians, in particular those who work in the private
healthcare sector, often deviate from standard, internationally recommended, tuberculosis
management practices.11,12 These deviations include: under-utilization of sputum
microscopy for diagnosis, generally associated with over-reliance on radiography; use of
non-recommended drug regimens, with incorrect combinations of drugs and mistakes in
both drug dosage and duration of treatment; and failure to supervise and assure adherence
to treatment.11,12,15–21 Anecdotal evidence also suggests over-reliance on poorly
validated or inappropriate diagnostic tests, such as serologic assays, often in preference
to conventional bacteriological evaluations.

Together these findings highlight flaws in healthcare practices that lead to substandard
tuberculosis care for populations that, sadly, are most vulnerable to the disease and are
least able to bear the consequences of such systemic failures. Any person anywhere in
the world who is unable to access quality health care should be considered vulnerable
to tuberculosis and its consequences.1 Likewise, any community with no or inadequate
access to appropriate diagnostic and treatment services for tuberculosis is a vulnerable
community.1 The development of the ISTC is an attempt to reduce vulnerability of individuals
and communities to tuberculosis by promoting high-quality care for persons with, or
suspected of having, tuberculosis.

Companion and Reference Documents

The Standards in this document are complementary to two other important companion
documents. The fi rst, Patients’ Charter for Tuberculosis Care (http://www.worldcarecouncil.
org), specifi es the rights and responsibilities of patients and has been developed in
tandem with this document. Second, the International Council of Nurses has developed
a set of standards, TB/MDR-TB Nursing Standards (www.icn.ch/tb/standards.htm), that
define in detail the critical roles and responsibilities of nurses in the care and control of
tuberculosis. As a single-source reference for many of the practices for tuberculosis care,
we refer the reader to Toman’s Tuberculosis: Case Detection, Treatment, and Monitoring
(second edition).22

There are many guidelines and recommendations on various aspects of tuberculosis care
and control. (For listing, see http://www.nationaltbcenter.edu/international/.) The Standards
draw from many of these documents to provide their evidence base. In particular,
we have relied on guidelines that are generally accepted because of the process by which
they were developed, and by their broad use. However, existing guidelines, although
implicitly based on standards, do not present standards that defi ne the acceptable level
of care in such a way as to enable assessment of the adequacy of care by patients themselves,
by communities, and by public health authorities.

In providing the evidence base for the Standards, generally we have cited summaries,
meta-analyses, and systematic reviews of evidence that have examined and synthesized
primary data, rather than referring to the primary data itself. Throughout the document
we have used the terminology recommended in the “Revised International Defi nitions in
Tuberculosis Control.”23