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provided valuable input. All comments received were given serious consideration by the
co-chairs, although not all were incorporated into the document.
The following individuals had substantive comments on one or more drafts of the ISTC
that have been taken into account in the fi nal document. The inclusion of their names
does not imply their approval of the fi nal document.
• Christian Auer
• Mohammed Abdel Aziz
• Susan Bachellor
• Jane Carter
• Richard Chaisson
• Daniel Chin
• Tin Maung Cho
• David Cohn
• Pierpaolo de Colombani
• Francis Drobniewski
• Mirtha Del Granado
• Don Enarson
• Asma El Soni
• Anne Fanning
• Chris Green
• Mark Harrington
• Myriam Henkens
• Michael Iademarco
• Kitty Lambregts
• Mohammad Reza Masjedi
• Thomas Moulding
• PR Narayanan
• Jintana Ngamvithayapong-Yanai
• Hans L. Rieder
• S. Bertel Squire
• Roberto Tapia
• Ted Torfoss
• Francis Varaine
• Kai Vink
ACKNOWLEDGEMENTS 3
4 INTERNATIONAL STANDARDS FOR TUBERCULOSIS CARE (ISTC) JANUARY 2006
List of Abbreviations
AFB Acid-fast bacilli
ATS American Thoracic Society
CDC Centers for Disease Control and Prevention
CI Confi dence interval
COPD Chronic obstructive pulmonary disease
DOT Directly observed treatment
DOTS The internationally recommended strategy for tuberculosis control
DST Drug susceptibility testing
EMB Ethambutol
FDC Fixed-dose combination
HAART Highly active antiretroviral therapy
HIV Human immunodefi ciency virus
IDSA Infectious Diseases Society of America
INH Isoniazid
IMAAI Integrated Management of Adolescent and Adult Illness
IMCI Integrated Management of Childhood Illness
ISTC International Standards for Tuberculosis Care
IUATLD International Union Against Tuberculosis and Lung Disease (The Union)
KNCV Royal Netherlands Tuberculosis Foundation
LTBI Latent tuberculosis infection
MIC Minimal inhibitory concentration
MDR Multiple drug resistance
NAAT Nucleic acid amplifi cation test
NTP National tuberculosis control program
PZA Pyrazinamide
RIF Rifampicin
RR Risk ratio
STI Sexually transmitted infection
TB Tuberculosis
TBCTA Tuberculosis Coalition for Technical Assistance
USAID United States Agency for International Development
WHO World Health Organization
ZN Ziehl-Neelsen staining
Summary
The purpose of the International Standards for Tuberculosis Care (ISTC) is to de-
scribe a widely accepted level of care that all practitioners, public and private,
should seek to achieve in managing patients who have, or are suspected
of having, tuberculosis. The Standards are intended to facilitate the ef-
fective engagement of all care providers in delivering high-quality care
for patients of all ages, including those with sputum smear-positive,
sputum smear-negative, and extra pulmonary tuberculosis, tubercu-
losis caused by drug-resistant Mycobacterium tuberculosis com-
plex (M. tuberculosis) organisms, and tuberculosis combined with
human immunodefi ciency virus (HIV) infection.
The basic principles of care for persons with, or suspected of
having, tuberculosis are the same worldwide: a diagnosis should
be established promptly and accurately; standardized treatment
regimens of proven effi cacy should be used with appropriate
treatment support and supervision; the response to treatment
should be monitored; and the essential public health respon-
sibilities must be carried out. Prompt, accurate diagnosis and
effective treatment are not only essential for good patient care—
they are the key elements in the public health response to tu-
berculosis and the cornerstone of tuberculosis control. Thus, all
providers who undertake evaluation and treatment of patients with
tuberculosis must recognize that, not only are they delivering care
to an individual, they are assuming an important public health function that entails a high
level of responsibility to the community, as well as to the individual patient.
Although government tuberculosis program providers are not exempt from adherence
to the Standards, non-program providers are the main target audience. It should be em-
phasized, however, that national and local tuberculosis control programs may need to
develop policies and procedures that enable non-program providers to adhere to the
Standards. Such accommodations may be necessary, for example, to facilitate treatment
supervision and contact investigations.
In addition to healthcare providers and government tuberculosis programs, both patients
and communities are part of the intended audience. Patients are increasingly aware of
and expect that their care will measure up to a high standard as described in the Patients’
Charter for Tuberculosis Care. Having generally agreed-upon standards will empower
patients to evaluate the quality of care they are being provided. Good care for individuals
with tuberculosis is also in the best interest of the community.
The Standards are intended to be complementary to local and national tuberculosis con-
trol policies that are consistent with World Health Organization (WHO) recommendations.
They are not intended to replace local guidelines and were written to accommodate local
differences in practice. They focus on the contribution that good clinical care of individual
patients with or suspected of having tuberculosis makes to population-based tubercu-
losis control. A balanced approach emphasizing both individual patient care and public
health principles of disease control is essential to reduce the suffering and economic
losses from tuberculosis.
The Standards
are intended to
facilitate the effective
engagement of
all care providers
in delivering high-
quality care for
patients of all ages
and all forms of
TB including drug-
resistant TB and TB
combined with HIV
infection.
SUMMARY 5
6 INTERNATIONAL STANDARDS FOR TUBERCULOSIS CARE (ISTC) JANUARY 2006
The Standards should be viewed as a living document that will be revised as technology,
resources, and circumstances change. As written, the Standards are presented within a
context of what is generally considered to be feasible now or in the near future.
The Standards are also intended to serve as a companion to and support for the Pa-
tients’ Charter for Tuberculosis Care developed in tandem with the Standards. The Char-
ter specifi es patients’ rights and responsibilities and will serve as a set of standards from
the point of view of the patient, defi ning what the patient should expect from the provider
and what the provider should expect from the patient.
Standards for Diagnosis
Standard 1. All persons with otherwise unexplained productive cough lasting two–three
weeks or more should be evaluated for tuberculosis.
Standard 2. All patients (adults, adolescents, and children who are capable of produc-
ing sputum) suspected of having pulmonary tuberculosis should have at
least two, and preferably three, sputum specimens obtained for micro-
scopic examination. When possible, at least one early morning specimen
should be obtained.
Standard 3. For all patients (adults, adolescents, and children) suspected of having
extrapulmonary tuberculosis, appropriate specimens from the suspect-
ed sites of involvement should be obtained for microscopy and, where
facilities and resources are available, for culture and histopathological
examination.
Standard 4. All persons with chest radiographic fi ndings suggestive of tuberculosis
should have sputum specimens submitted for microbiological examination.
Standard 5. The diagnosis of sputum smear-negative pulmonary tuberculosis should
be based on the following criteria: at least three negative sputum smears
(including at least one early morning specimen); chest radiography fi nd-
ings consistent with tuberculosis; and lack of response to a trial of broad-
spectrum antimicrobial agents. (NOTE: Because the fl uoroquinolones are
active against M. tuberculosis complex and, thus, may cause transient
improvement in persons with tuberculosis, they should be avoided.) For
such patients, if facilities for culture are available, sputum cultures should
be obtained. In persons with known or suspected HIV infection, the diag-
nostic evaluation should be expedited.
Standard 6. The diagnosis of intrathoracic (i.e., pulmonary, pleural, and mediastinal or
hilar lymph node) tuberculosis in symptomatic children with negative spu-
tum smears should be based on the fi nding of chest radiographic abnor-
malities consistent with tuberculosis and either a history of exposure to an
infectious case or evidence of tuberculosis infection (positive tuberculin
skin test or interferon gamma release assay). For such patients, if facilities
for culture are available, sputum specimens should be obtained (by expec-
toration, gastric washings, or induced sputum) for culture.
Standards for Treatment
Standard 7. Any practitioner treating a patient for tuberculosis is assuming an important
public health responsibility. To fulfi ll this responsibility the practitioner must
not only prescribe an appropriate regimen but, also, be capable of as-
sessing the adherence of the patient to the regimen and addressing poor
adherence when it occurs. By so doing, the provider will be able to ensure
adherence to the regimen until treatment is completed.
Standard 8. All patients (including those with HIV infection) who have not been treated
previously should receive an internationally accepted fi rst-line treatment
regimen using drugs of known bioavailability. The initial phase should con-
sist of two months of isoniazid, rifampicin, pyrazinamide, and ethambutol.
The preferred continuation phase consists of isoniazid and rifampicin given
for four months. Isoniazid and ethambutol given for six months is an al-
ternative continuation phase regimen that may be used when adherence
cannot be assessed, but it is associated with a higher rate of failure and
relapse, especially in patients with HIV infection.
The doses of antituberculosis drugs used should conform to international
recommendations. Fixed-dose combinations of two (isoniazid and rifam-
picin, three (isoniazid, rifampicin, and pyrazinamide), and four (isoniazid,
rifampicin, pyrazinamide, and ethambutol) drugs are highly recommended,
especially when medication ingestion is not observed.
Standard 9. To foster and assess adherence, a patient-centered approach to adminis-
tration of drug treatment, based on the patient’s needs and mutual respect
between the patient and the provider, should be developed for all patients.
Supervision and support should be gender-sensitive and age-specifi c and
should draw on the full range of recommended interventions and available
support services, including patient counseling and education. A central
element of the patient-centered strategy is the use of measures to assess
and promote adherence to the treatment regimen and to address poor ad-
herence when it occurs. These measures should be tailored to the individ-
ual patient’s circumstances and be mutually acceptable to the patient and
the provider. Such measures may include direct observation of medication
ingestion (directly observed therapy—DOT) by a treatment supporter who
is acceptable and accountable to the patient and to the health system.
Standard 10. All patients should be monitored for response to therapy, best judged in
patients with pulmonary tuberculosis by follow-up sputum microscopy (two
specimens) at least at the time of completion of the initial phase of treat-
ment (two months), at fi ve months, and at the end of treatment. Patients
who have positive smears during the fi fth month of treatment should be
considered as treatment failures and have therapy modifi ed appropriately.
(See Standards 14 and 15.) In patients with extrapulmonary tuberculosis
and in children, the response to treatment is best assessed clinically.
SUMMARY 7
8 INTERNATIONAL STANDARDS FOR TUBERCULOSIS CARE (ISTC) JANUARY 2006
Follow-up radiographic examinations are usually unnecessary and may be
misleading.
Standard 11. A written record of all medications given, bacteriologic response, and
adverse reactions should be maintained for all patients.
Standard 12. In areas with a high prevalence of HIV infection in the general popula-
tion and where tuberculosis and HIV infection are likely to co-exist, HIV
counseling and testing is indicated for all tuberculosis patients as part of
their routine management. In areas with lower prevalence rates of HIV, HIV
counseling and testing is indicated for tuberculosis patients with symp-
toms and/or signs of HIV-related conditions and in tuberculosis patients
having a history suggestive of high risk of HIV exposure.
Standard 13. All patients with tuberculosis and HIV infection should be evaluated to de-
termine if antiretroviral therapy is indicated during the course of treatment
for tuberculosis. Appropriate arrangements for access to antiretroviral
drugs should be made for patients who meet indications for treatment.
Given the complexity of co-administration of antituberculosis treatment
and antiretroviral therapy, consultation with a physician who is expert in
this area is recommended before initiation of concurrent treatment for tu-
berculosis and HIV infection, regardless of which disease appeared fi rst.
However, initiation of treatment for tuberculosis should not be delayed.
Patients with tuberculosis and HIV infection should also receive cotrimoxa-
zole as prophylaxis for other infections.
Standard 14. An assessment of the likelihood of drug resistance, based on history of
prior treatment, exposure to a possible source case having drug-resistant
organisms, and the community prevalence of drug resistance, should be
obtained for all patients. Patients who fail treatment and chronic cases
should always be assessed for possible drug resistance. For patients in
whom drug resistance is considered to be likely, culture and drug suscepti-
bility testing for isoniazid, rifampicin, and ethambutol should be performed
promptly.
Standard 15. Patients with tuberculosis caused by drug-resistant (especially multiple-
drug resistant [MDR]) organisms should be treated with specialized regi-
mens containing second-line antituberculosis drugs. At least four drugs
to which the organisms are known or presumed to be susceptible should
be used, and treatment should be given for at least 18 months. Patient-
centered measures are required to ensure adherence. Consultation with
a provider experienced in treatment of patients with MDR tuberculosis
should be obtained.
Standards for Public Health Responsibilities
Standard 16. All providers of care for patients with tuberculosis should ensure that per-
sons (especially children under 5 years of age and persons with HIV infec-
tion) who are in close contact with patients who have infectious tuberculo-
sis are evaluated and managed in line with international recommendations.
Children under 5 years of age and persons with HIV infection who have
been in contact with an infectious case should be evaluated for both latent
infection with M. tuberculosis and for active tuberculosis.
Standard 17. All providers must report both new and retreatment tuberculosis cases and
their treatment outcomes to local public health authorities, in conformance
with applicable legal requirements and policies.
Research Needs
As part of the process of developing the ISTC, several key areas that require additional
research were identifi ed. Systematic reviews and research studies (some of which are
underway currently) in these areas are critical to generate evidence to support rational
and evidence-based care and control of tuberculosis. Research in these operational and
clinical areas serves to complement ongoing efforts focused on developing new tools for
tuberculosis control.
SUMMARY 9
10 INTERNATIONAL STANDARDS FOR TUBERCULOSIS CARE (ISTC) JANUARY 2006
Introduction
Purpose
The purpose of the International Standards
for Tuberculosis Care (ISTC) is to describe a
widely accepted level of care that all practi-
tioners, public and private, should seek to
achieve in managing patients who have,
or are suspected of having, tuberculosis.
The Standards are intended to facilitate
the effective engagement of all care
providers in delivering high-quality care
for patients of all ages, including those
with sputum smear-positive, sputum
smear-negative, and extrapulmonary
tuberculosis, tuberculosis caused by
drug-resistant Mycobacterium tuber-
culosis complex (M. tuberculosis) or-
ganisms, and tuberculosis combined
with HIV infection. A high standard of
care is essential to restore the health of
individuals with tuberculosis, to prevent
the disease in their families and others with
whom they come into contact, and to protect the health of communities.
1
Substandard
care will result in poor patient outcomes, continued infectiousness with transmission of M.
tuberculosis to family and other community members, and generation and propagation of
drug resistance. For these reasons, substandard care is not acceptable.
The standards in this document differ from existing guidelines in that standards pres-
ent what should be done, whereas, guidelines describe how the action is to be ac-
complished. Standards provide the foundation on which care can be based; guidelines
provide the framing for the whole structure of care. Guidelines and standards are, thus,
complementary to one another. A standard does not provide specifi c guidance on dis-
ease management but, rather, presents a principle or set of principles that can be applied
in nearly all situations. In general, standards do not require adaptation to local circum-
stances. Guidelines must be tailored to local conditions. In addition, a standard can be
used as an indicator of the overall adequacy of disease management against which indi-
vidual or collective practices can be measured, whereas guidelines are intended to assist
providers in making informed decisions about appropriate health interventions.
2
The basic principles of care for persons with, or suspected of having, tuberculosis are
the same worldwide: a diagnosis should be established promptly and accurately; stan-
dardized treatment regimens of proven effi cacy should be used with appropriate treat-
ment support and supervision; the response to treatment should be monitored; and the
essential public health responsibilities must be carried out. Prompt, accurate diagnosis
and effective treatment are not only essential for good patient care—they are the key ele-
ments in the public health response to tuberculosis and are the cornerstone of tubercu-
All providers who
undertake evaluation
and treatment of
patients with TB
must recognize that,
not only are they
delivering care to
an individual, they
are assuming an
important public
health function.
INTRODUCTION 11
12 INTERNATIONAL STANDARDS FOR TUBERCULOSIS CARE (ISTC) JANUARY 2006
losis control. Thus, all providers who undertake evaluation and treatment of patients with
tuberculosis must recognize that, not only are they delivering care to an individual, they
are assuming an important public health function that entails a high level of responsibility
to the community, as well as to the individual patient. Adherence to the standards in this
document will enable these responsibilities to be fulfi lled.
Audience
The Standards are addressed to all healthcare providers, private and public, who care for
persons with proven tuberculosis or with symptoms and signs suggestive of tuberculosis.
In general, providers in government tuberculosis programs that follow existing interna-
tional guidelines are in compliance with the Standards. However, in many instances (as
described under Rationale), clinicians (both private and public) who are not part of a tu-
berculosis control program lack the guidance and systematic evaluation of outcomes pro-
vided by government control programs, and, commonly, would not be in compliance with
the Standards. Thus, although government program providers are not exempt from ad-
herence to the Standards, non-program providers are the main target audience. It should
be emphasized, however, that national and local tuberculosis control programs may need
to develop policies and procedures that enable non-program providers to adhere to the
Standards. Such accommodations may be necessary, for example, to facilitate treatment
supervision and contact investigations.
In addition to healthcare providers and government tuberculosis programs, both patients
and communities are part of the intended audience. Patients are increasingly aware of
and expect that their care will measure up to a high standard as described in the Patients’
Charter for Tuberculosis Care. Having generally agreed-upon standards will empower
patients to evaluate the quality of care they are being provided. Good care for individuals
with tuberculosis is also in the best interest of the community. Community contributions to
tuberculosis care and control are increasingly important in raising public awareness of the
disease, providing treatment support, encouraging adherence, reducing the stigma as-
sociated with having tuberculosis, and demanding that healthcare providers in the com-
munity adhere to a high standard of tuberculosis care.
3
The community should expect
that care for tuberculosis will be up to the accepted standard.
Scope
Three categories of activities are addressed by the Standards: diagnosis, treatment, and
public health responsibilities of all providers. Specifi c prevention approaches, laboratory
performance, and personnel standards are not addressed. The Standards are intended
to be complementary to local and national tuberculosis control policies that are consistent
with World Health Organization (WHO) recommendations. They are not intended to re-
place local guidelines and were written to accommodate local differences in practice. They
focus on the contribution that good clinical care of individual patients with, or suspected
of having, tuberculosis makes to population-based tuberculosis control. A balanced ap-
proach emphasizing both individual patient care and public health principles of disease
control is essential to reduce the suffering and economic losses from tuberculosis.
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