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Updating the International Standards for Tuberculosis Care

Entering the Era of Molecular Diagnostics
Philip C. Hopewell1, Elizabeth L. Fair1, and Mukund Uplekar2
Curry International Tuberculosis Center, University of California, San Francisco, San Francisco, California; and 2Global Tuberculosis
Program, World Health Organization, Geneva, Switzerland

Abstract performance characteristics for detecting Mycobacterium

tuberculosis and rifampin resistance, and that are practical and
The International Standards for Tuberculosis Care, rst published affordable for use in decentralized facilities in low-resource
in 2006 (Lancet Infect Dis 2006;6:710725.) with a second edition settings, is being widely deployed globally. Used appropriately,
in 2009 (www.currytbcenter.ucsf.edu/international/istc_report), both within tuberculosis control programs and in private
was produced by an international coalition of organizations laboratories, these devices have the potential to revolutionize
funded by the United States Agency for International tuberculosis care and control, providing a conrmed diagnosis
Development. Development of the document was led jointly by the and a determination of rifampin resistance within a few hours,
World Health Organization and the American Thoracic Society, enabling appropriate treatment to be initiated promptly. Major
with the aim of promoting engagement of all care providers, changes have been made in the standards for diagnosis. Additional
especially those in the private sector in low- and middle-income important changes include: emphasis on the recognition of groups
countries, in delivering high-quality services for tuberculosis. In at increased risk of tuberculosis; updating the standard on
keeping with World Health Organization recommendations antiretroviral treatment in persons with tuberculosis and human
regarding rapid molecular testing, as well as other pertinent new immunodeciency virus infection; and revising the standard on
recommendations, the third edition of the Standards has been treating multiple drugresistant tuberculosis.
developed. After decades of dormancy, the technology available
for tuberculosis care and control is now rapidly evolving. In Keywords: tuberculosis; drug resistance; human
particular, rapid molecular testing, using devices with excellent immunodeciency virus infection; diagnosis; treatment

(Received in original form January 5, 2014; accepted in final form January 6, 2014 )
Supported by the United States Agency for International Development, which funded the development of the International Standards for Tuberculosis Care
through the TB CARE 1 coalition*.
*TB CARE I is a coalition of organizations funded by the United States Agency for International Development to implement a portion of its tuberculosis program.
The organizations are the American Thoracic Society, FHI 360, the Japan Antituberculosis Association, the KNCV Tuberculosis Foundation, Management
Sciences for Health, the International Union against Tuberculosis and Lung Disease, and the World Health Organization.
The views expressed in this article do not communicate an official position of the United States Agency for International Development. M.U. is a staff member of
the World Health Organization (WHO); the views expressed in this article are his own, and do not necessarily represent WHO policies.
Correspondence and requests for reprints should be addressed to Philip C. Hopewell, M.D., Division of Pulmonary and Critical Care Medicine, Room 5K1 San
Francisco General Hospital, San Francisco, CA 94110. E-mail: phopewell@medsfgh.ucsf.edu
Ann Am Thorac Soc Vol 11, No 3, pp 277285, Mar 2014
Published 2014 by the American Thoracic Society
DOI: 10.1513/AnnalsATS.201401-004AR
Internet address: www.atsjournals.org

The International Standards for Tuberculosis accessed at www.istcweb.org, and at www. (USAID). Development of all three editions
Care (ISTC) was rst published in 2006, currytbcenter.ucsf.edu/international/istc, as of the ISTC was led jointly by the World
with a second edition in 2009 (1, 15). Recent well as at the websites of the TB CARE 1 Health Organization (WHO) and the
advances in the diagnosis and treatment of organizations) (3). As with the rst two American Thoracic Society. The ISTC aims
tuberculosis have prompted the publication editions, the third edition was produced by to promote engagement of all care providers,
of a third edition of the ISTC, which was an international coalition of organizations, especially those in the private sector in
released on World TB Day 2014 (March 24; TB CARE 1, funded by the United States low- and middle-income countries, in
the complete version of the document can be Agency for International Development delivering high-quality services for tuberculosis.

Hopewell, Fair, and Uplekar: Updating International Standards for TB Care 277

Edition 1 of the ISTC stated, The information and recommendations problem. It is estimated that one-third of
Standards should be viewed as a living regarding diagnostic test technology, the worlds population is infected with
document that will be revised as additional important changes in Edition 3 M. tuberculosis, mostly in developing
technology, resources, and circumstances include: emphasis on the recognition of countries, where 95% of cases occur. In
change (1, 2). After decades of dormancy, groups at increased risk of tuberculosis and 2012, there were an estimated 8.6 million
the technology available for tuberculosis considerations for screening within such new cases of tuberculosis (8). The number
care and control is now rapidly evolving. In groups; updating the standard on antiretroviral of tuberculosis cases that occur in the world
particular, rapid molecular testing, using treatment to indicate that treatment should each year has been declining slightly for
devices that have excellent performance be initiated promptly for any person with the past few years, and the global incidence
characteristics for detecting Mycobacterium tuberculosis and HIV infection; and revising per 100,000 population is decreasing at just
tuberculosis and rifampicin resistance, and the standard on treating multiple drug over 2% per year (8).
are practical and affordable for use in resistant tuberculosis to be consistent with the Incidence, prevalence, and mortality
decentralized facilities in low-resource 2011 WHO update (15). are now decreasing in all six of the WHO
settings, is now widely available and are It should be emphasized that the basic regions. In Africa, the case rate has only
being widely deployed globally (46). Used principles that underlie the ISTC have not recently begun to decrease, but remains very
appropriately, both within tuberculosis changed. Case detection and curative high both, because of the epidemic of HIV
control programs and in private treatment remain the cornerstones of infection in sub-Saharan countries and
laboratories, these devices have the tuberculosis care and control, and the the poor health systems and primary care
potential to revolutionize tuberculosis care fundamental responsibility of providers to services throughout the region. In Eastern
and control by providing a conrmed ensure completion of treatment is Europe, after a decade of increases, case rates
diagnosis and a determination of drug unchanged. Within these basic principles, reached a plateau in the early 2000s and
resistance within a few hours, enabling however, there have been changes that are now have begun to decrease slightly.
appropriate treatment to be initiated of sufcient importance to be incorporated However, in many countries, because of
promptly, thereby, reducing ongoing into the ISTC. Tables 14 present the incomplete application of proven care and
transmission of the organism. The revised standards and summarize the control measures, tuberculosis case rates are
availability and increasing use of rapid changes in Edition 3 compared with either stagnant or decreasing more slowly
molecular testing, together with substantial Edition 2 (16). than should be expected. This is especially
guidance from the WHO, have highlighted true in high-risk groups, such as persons
the need for revision of the ISTC to be with HIV infection, the homeless, and
consistent with current guidelines (4, 6). Development Process recent immigrants. The failure to bring
In addition to new technologic about a more rapid reduction in
approaches, circumstances have changed. As with Editions 1 and 2, Edition 3 was tuberculosis incidence, at least in part,
The treatment strategy recommended by the funded by USAID via TB CARE I. A steering relates to a failure to fully engage providers
WHO, known as DOTS, has now been committee from the Global TB Program at who are not part of tuberculosis control
widely implemented and has been highly WHO identied areas in which revisions programs in the provision of high-quality
successful (7, 8). The global tuberculosis were needed. It was felt that no new care, in coordination with local and
case rate is declining, although the decline systematic reviews were needed for this national control programs. Fostering such
of approximately 2% per year is far too edition, because the standards in the ISTC engagement is an important purpose of
slow. The success of DOTS in the diagnosis are all supported by existing WHO the ISTC.
and treatment of usual tuberculosis now guidelines and policy statements, many of It is widely recognized that many
enables an intensied focus on the problem which had recently been developed using providers are involved in the diagnosis and
areas that remain: improving the speed and rigorous methodology, including systematic treatment of tuberculosis (14). Traditional
completeness of case detection, thereby reviews (17). The initial draft document healers, general and specialist physicians
reducing transmission of M. tuberculosis; was then reviewed by an expert committee in private practice, nurses, clinical
addressing drug-resistant tuberculosis; of 27 members from 13 countries. ofcers, academic physicians, unlicensed
effectively managing tuberculosis in Subsequent drafts were reviewed and practitioners, and community
persons with comorbidities, especially approved by the expert committee. In organizations, among others, all play roles
human immunodeciency virus (HIV) addition, the nal draft was reviewed and in tuberculosis care and, therefore, in
infection; and developing approaches to approved by the TB CARE I member tuberculosis control. In addition, other
tuberculosis detection and prevention in organizations (see footnote). public sector providers, such as those
groups at increased risk of the disease working in prisons, army hospitals, or
(913). In addition, it is recognized that public hospitals and facilities, regularly
DOTS implementation only by the public Rationale evaluate persons suspected of having
sector of the health care system is insufcient tuberculosis and treat patients who have
to bring about true tuberculosis control, Although in the past decade there has been the disease.
and that new, broader-based approaches substantial progress in the development and Little is known about the adequacy
must be implemented in both public and implementation of the strategies necessary of care delivered outside of tuberculosis
private sectors (14). Consequently, in for effective tuberculosis control, the disease control programs, but evidence from studies
addition to the incorporation of new remains an enormous global health conducted in many parts of the world show

278 AnnalsATS Volume 11 Number 3 | March 2014


Table 1. International Standards for Tuberculosis Care, Edition 3: Standards for Diagnosis

Standard Key Differences from Edition 2

Standard 1 To ensure early diagnosis, providers must be aware This is a new standard emphasizing the
of individual and group risk factors for responsibility of providers to be aware of
tuberculosis and perform prompt clinical individual and population risk factors for
evaluations and appropriate diagnostic testing for tuberculosis and to reduce diagnostic delay.
persons with symptoms and ndings consistent
with tuberculosis.
Standard 2 All patients (including children) with unexplained Formerly Standard 1. The wording has been
cough lasting >2 weeks or with unexplained changed to include radiographic abnormalities
ndings suggestive of tuberculosis on chest as an indication for evaluation for tuberculosis.
radiographs should be evaluated for tuberculosis. The standard emphasizes the importance of
including not only cough, but fever, night sweats,
and weight loss, as indications for evaluation for
Standard 3 All patients (including children) who are suspected Formerly Standard 2. The current WHO
of having pulmonary tuberculosis and are recommendations for use of rapid molecular
capable of producing sputum should have at testing as the initial microbiologic test in specied
least two sputum specimens submitted for smear patients are now included. The recommendation
microscopy or a single sputum specimen for against using serologic assays for diagnosing
Xpert MTB/RIF testing in a quality-assured tuberculosis is emphasized.
laboratory. Patients at risk for drug resistance
who have HIV risks, or who are seriously ill,
should have Xpert MTB/RIF performed as the
initial diagnostic test. Blood-based serologic
tests and interferon gamma release assays
should not be used for diagnosis of active
Standard 4 For all patients (including children) suspected of Formerly Standard 4. Now combined with Standard
having extrapulmonary tuberculosis, appropriate 1. The importance of microbiological diagnosis of
specimens from the suspected sites of extrapulmonary tuberculosis is emphasized.
involvement should be obtained for WHO recommendations for the use of rapid
microbiological and histopathological molecular testing for samples from
examination. An Xpert MTB/RIF test is extrapulmonary sites are included.
recommended as the preferred initial
microbiological test for suspected tuberculous
meningitis, because of the need for a rapid
Standard 5 In patients suspected of having pulmonary The WHO recommendations are presented for use
tuberculosis whose sputum smears are negative, of rapid molecular testing for diagnosis of
Xpert MTB/RIF and/or sputum cultures should be tuberculosis among persons who are suspected
performed. Among smear and Xpert- MTB/RIF of having the disease, but have negative sputum
negative persons with clinical evidence strongly smear microscopy.
suggestive of tuberculosis, antituberculosis
treatment should be initiated after collection of
specimens for culture examination.
Standard 6 In all children suspected of having intrathoracic The WHO recommendations are presented for the
(i.e., pulmonary, pleural, and mediastinal or hilar use of rapid molecular testing for the diagnosis of
lymph node) tuberculosis, bacteriological tuberculosis in children.
conrmation should be sought through
examination of respiratory secretions
(expectorated sputum, induced sputum, gastric
lavage) for smear microscopy, an Xpert MTB/RIF
test, and/or culture.

Definition of abbreviations: HIV = human immunodeficiency virus; MTB = Mycobacterium tuberculosis; RIF = rifampin; WHO = World Health Organization.
*At this time, the only system on the market that has these qualifications is the Xpert MTB/RIF device marketed by Cepheid Inc. (Sunnyvale, CA) and
codeveloped by David Alland at the University of Medicine and Dentistry of New Jersey, Cepheid, Inc., and Foundation for Innovative New Diagnostics,
with additional financial support from the U.S. National Institutes of Health. Because Xpert MTB/RIF is currently the only system with the requisite
characteristics, it is specifically cited in the recommendations of the WHO.

great variability in the quality of tuberculosis assessment reported by WHO suggested be important (21, 22). Even after a patient
care, and poor quality care continues to that delays in diagnosis were common (20). is found to have a positive sputum smear,
plague global tuberculosis control efforts The delay was more often in receiving delays are common (23). The WHO survey
even in low-prevalence, high-income a diagnosis rather than in seeking care, and other studies also show that clinicians,
settings (18, 19). A global situation although both elements have been shown to in particular those who work in the private

Hopewell, Fair, and Uplekar: Updating International Standards for TB Care 279

Table 2. International Standards for Tuberculosis Care, Edition 3: Standards for Treatment

Standard Key Differences from Edition 2

Standard 7 To fulll her/his public health responsibility, as well No change

as responsibility to the individual patient, the
provider must prescribe an appropriate treatment
regimen, monitor adherence to the regimen, and,
when necessary, address factors leading to
interruption or discontinuation of treatment.
Fullling these responsibilities will likely require
coordination with local public health services
and/or other local services.
Standard 8 All patients who have not been treated previously No change
and do not have other risk factors for drug
resistance should receive a WHO-approved rst-
line treatment regimen using quality-assured
drugs. The initial phase should consist of 2
months of isoniazid, rifampicin, pyrazinamide,
and ethambutol (ethambutol may be omitted in
children who are HIV negative and who have
noncavitary disease). The continuation phase
should consist of isoniazid and rifampicin given
for 4 months. The doses of antituberculosis drugs
used should conform to WHO recommendations.
Standard 9 A patient-centered approach to treatment should No change
be developed for all patients in order to promote
adherence, improve quality of life, and relieve
suffering. This approach should be based on the
patients needs and mutual respect between the
patient and the provider.
Standard 10 Response to treatment in patients with pulmonary The role of microscopy in monitoring response in
tuberculosis (including those with tuberculosis patients who had the diagnosis established by
diagnosed by a rapid molecular test) should be a rapid molecular test is described.
monitored by follow-up sputum smear
microscopy at the time of completion of the initial
phase of treatment (2 mo). If the sputum smear is
positive at completion of the initial phase, sputum
microscopy should be performed again at 3
months and, if positive, rapid molecular drug
sensitivity testing (line probe assays or Xpert
MTB/RIF) or culture with drug susceptibility
testing should be performed. In patients with
extrapulmonary tuberculosis and in children, the
response to treatment is best assessed clinically.
Standard 11 An assessment of the likelihood of drug resistance, This standard describes the use of Xpert MTB/RIF
based on history of prior treatment, exposure to in assessing for rifampicin resistance and line
a possible source case having drug-resistant probe assay for detecting resistance to both
organisms, and the community prevalence of isoniazid and rifampicin.
drug resistance (if known), should be obtained for
all patients. Drug susceptibility testing should be
performed at the start of therapy for all previously
treated patients. Patients who remain sputum
smear positive at completion of 3 months of
treatment and patients in whom treatment has
failed, have been lost to follow-up, or relapsed
after one or more courses of treatment should
always be assessed for drug resistance. For
patients in whom drug resistance is considered to
be likely, an Xpert MTB/RIF test should be the
initial diagnostic test. Line probe assay or culture
and testing for susceptibility to at least isoniazid
and rifampicin should be performed promptly if
rifamycin resistance is detected. Patient counseling
and education, as well as an empiric second-line
treatment regimen, should begin immediately to
minimize the potential for transmission. Infection
control measures appropriate to the setting should
be applied.
(Continued )

280 AnnalsATS Volume 11 Number 3 | March 2014


Table 2. (CONTINUED )
Standard Key Differences from Edition 2

Standard 12 Patients with or highly likely to have tuberculosis The standard has been changed to reect
caused by drug-resistant (especially MDR/XDR) the revised WHO recommendations for
organisms should be treated with specialized programmatic management of drug-resistant
regimens containing quality-assured second-line tuberculosis.
antituberculosis drugs. The doses of
antituberculosis drugs should conform to WHO
recommendations. The regimen chosen may be
standardized or based on suspected or
conrmed drug susceptibility patterns. At least
pyrazinamide and four drugs to which the
organisms are known or presumed to be
susceptible, including an injectable agent, should
be used in an 8-month intensive phase, and at
least three drugs to which the organisms are
known or presumed to be susceptible should be
used in the continuation phase. Treatment should
be given for at least 1824 months beyond
culture conversion. Patient-centered measures,
including observation of treatment, are required
to ensure adherence. Consultation with
a specialist experienced in treatment of patients
with MDR/XDR tuberculosis should be obtained.
Standard 13 An accessible, systematically maintained record of No change
all medications given, bacteriologic response,
outcomes, and adverse reactions should be
maintained for all patients.

Definition of abbreviations: HIV = human immunodeficiency virus; MDR = multiple drugresistant; MTB = Mycobacterium tuberculosis; RIF = rifampin;
WHO = World Health Organization; XDR = extensively drug-resistant.

healthcare sector, often deviate from Tuberculosis care (including prevention) Prevention, Care, and Control developed by
standard, internationally recommended is a public good. The disease not only the WHO (28).
tuberculosis management practices. These threatens the health of individualsthe
deviations include: underutilization of health of the community is also at risk. It is
microbiological tests for diagnosis, generally agreed that universal access to Purpose and Scope
generally associated with overreliance on health care is a human right, and that
radiography; use of nonrecommended drug governments have the ethical responsibility The fundamental purpose of the ISTC is
regimens with incorrect combinations of to ensure access, a responsibility that to improve the care of patients with or
drugs and mistakes in both drug dosage includes access to quality-assured suspected of having tuberculosis, as well as
and duration of treatment; and failure to tuberculosis services. In particular, for those at increased risk of the disease,
supervise and assure adherence to tuberculosis disproportionately affects poor regardless of their source of care. The ISTC
treatment (1820, 24). Evidence also and marginalized people, groups that is intended to promote the effective
indicates overreliance on poorly validated governments and health care systems engagement of all care providers in
or inappropriate diagnostic tests, such as have an ethical obligation to protect. delivering high-quality care using established
serologic assays, often in preference to Tuberculosis not only thrives on poverty, best practices. As such, the ISTC will provide
conventional bacteriological evaluations it breeds poverty by consuming limited private sectorfocused support to the
(25). Because of the unreliability of these personal and family resources. Poor care high-quality integrated TB care and
tests, WHO has taken the unusual step of compounds the costs that already prevention component of WHOs Post
specically recommending against their use impoverished individuals and families 2015 Strategy, currently under development.
(26). cannot afford, and commonly results in Engagement of all providers is a critical
Together, these ndings highlight aws persons being unable to work for long component of the updated strategy, and the
in health care practices that lead to periods, while at the same time incurring ISTC will serve as a means of promoting
substandard tuberculosis care for catastrophic costs (29, 30). Substandard implementation of the strategy, especially
populations that, sadly, are most vulnerable care, be it on the part of program or among nonprogram providers.
to the disease, and are least able to bear the nonprogram providers, is unethical. The The ISTC describes a widely accepted
consequences of such systemic failures (27). care and control measures in the ISTC level of care that all practitioners, public
Thus, there is an ethical underpinning describe approaches to tuberculosis care, and private, should seek to achieve in
that applies equally to program and control, and prevention that are consistent managing patients who have, or are
nonprogram providers, to the provision of with the ethical standards articulated by suspected of having, tuberculosis. The ISTC
effective, appropriate tuberculosis care (28). the Guidance on Ethics of Tuberculosis focuses on the contribution of good clinical

Hopewell, Fair, and Uplekar: Updating International Standards for TB Care 281

Table 3. International Standards for Tuberculosis Care, Edition 3: Standards for Addressing Human Immunodeciency Virus
Infection and Other Comorbid Conditions

Standard Key Differences from Edition 2

Standard 14 HIV testing and counseling should be conducted No change

for all patients with, or suspected of having,
tuberculosis unless there is a conrmed negative
test within the previous 2 months. Because of the
close relationship of tuberculosis and HIV
infection, integrated approaches to prevention,
diagnosis, and treatment of both tuberculosis
and HIV infection are recommended in areas with
high HIV prevalence. HIV testing is of special
importance as part of routine management of all
patients in areas with a high prevalence of HIV
infection in the general population, in patients
with symptoms and/or signs of HIV-related
conditions, and in patients having a history
suggestive of high risk of HIV exposure.
Standard 15 In persons with HIV infection and tuberculosis who The standard has been modied to reect the
have profound immunosuppression (CD4 counts current WHO recommendations for treating HIV
,50 cells/mm3), ART should be initiated within 2 in people living with HIV who have tuberculosis.
weeks of beginning treatment for tuberculosis
unless tuberculous meningitis is present. For all
other patients with HIV and tuberculosis,
regardless of CD4 counts, antiretroviral therapy
should be initiated within 8 weeks of beginning
treatment for tuberculosis. Patients with
tuberculosis and HIV infection should also
receive cotrimoxazole as prophylaxis for other
Standard 16 Persons with HIV infection who, after careful No change
evaluation, do not have active tuberculosis
should be treated for presumed latent
tuberculosis infection with isoniazid for at least
6 months.
Standard 17 All providers should conduct a thorough No change
assessment for comorbid conditions and other
factors that could affect tuberculosis treatment
response or outcome, and identify additional
services that would support an optimal outcome
for each patient. These services should be
incorporated into an individualized plan of care
that includes assessment of and referrals for
treatment of other illnesses. Particular attention
should be paid to diseases or conditions known
to affect treatment outcomefor example,
diabetes mellitus, drug and alcohol abuse,
undernutrition, and tobacco smoking. Referrals to
other psychosocial support services, or to such
services as antenatal or well baby care, should
also be provided.

Definition of abbreviations: ART = antiretroviral treatment; HIV = human immunodeficiency virus; WHO = World Health Organization.

care of individual patients with or suspected the WHO using a rigorous, evidence-based efcacy should be used, together with
of having tuberculosis, and on appropriate approach (17). In this regard, the ISTC appropriate treatment support and
prevention measures in persons with presents a compendium of WHO-produced supervision to assure successful completion
increased risks for the disease. A balanced recommendations that are of particular of the prescribed regimen; the response
approach, emphasizing both individual relevance to private providers in a context to treatment should be monitored; and
patient care and public health principles of of care of individual patients. essential public health responsibilities,
disease control, is essential to reducing the The basic principles of care for persons including case notication, must be
suffering and individual and community with, or suspected of having, tuberculosis performed. The ways in which these
economic losses from tuberculosis. are the same worldwide: a diagnosis should principles are applied vary depending on
Much of the content of the ISTC is be established promptly and accurately; available technology, epidemiological
based on recommendations developed by standardized treatment regimens of proven circumstances, and resources. However,

282 AnnalsATS Volume 11 Number 3 | March 2014


Table 4. International Standards for Tuberculosis Care, Edition 3: Standards for among the factors that interfere with
Diagnosis: Standards for Public Health and Prevention persons seeking or receiving care. Also not
addressed by the ISTC is the necessity of
Standard Key Differences from having a sound, effective tuberculosis
Edition 2 control program based on established
public health principles. The level of care
Standard 18 All providers should ensure that persons who No change described in the ISTC cannot be achieved
are in close contact with patients who have without there being an enabling
infectious tuberculosis are evaluated and environment, generally provided by an
managed in line with international effective public health program supported
recommendations. The highest priority
contacts for evaluation are: by appropriate legal and regulatory
d Persons with symptoms suggestive of framework and nancial resources. The
tuberculosis. requirements of such programs are
d Children aged ,5 years.
described in publications from WHO and
d Contacts with known or suspected
immunocompromised states, particularly the Union (31, 32). Having an effective
HIV infection. control program at the national or local
d Contacts of patients with MDR/XDR level with linkages to nonprogram providers
tuberculosis. enables bidirectional communication of
Standard 19 Children ,5 years of age and persons of any No change information, including case notication,
age with HIV infection who are close
contacts of a person with infectious consultation, patient referral, provision of
tuberculosis and who, after careful drugs or services, such as treatment
evaluation, do not have active tuberculosis, supervision/support for private patients,
should be treated for presumed latent and contact evaluation. In addition, the
tuberculosis infection with isoniazid for at
least 6 months. program may be the only source of
laboratory services for the private sector.
Definition of abbreviations: HIV = human immunodeficiency virus; MDR = multiple drugresistant;
XDR = extensively drug-resistant.
prompt, accurate diagnosis and effective a context of what is generally considered to
timely treatment are not only essential for be feasible now or in the near future. Clinicians (both private and public) who are
good patient care, they are the key elements There is continued recognition that not all not part of a government-funded
in the public health response to tuberculosis, of the standards in this edition can be met tuberculosis control program are the main
and are the cornerstone of tuberculosis in all places at this time. However, given target audience. These providers generally
control. Thus, all providers who undertake the rapidity of technical advances and lack the guidance and systematic evaluation
evaluation and treatment of patients with deployment of new technologies and of outcomes provided by programs and,
tuberculosis must recognize that, not only approaches, it is anticipated that commonly, are not in compliance with the
are they delivering care to an individual, compliance with the standards will be ISTC. It should be emphasized, however,
they are assuming an important public possible in most places in the near future. that public tuberculosis control programs
health function that entails a high level It is hoped that having standards that are may need to develop policies and
of responsibility to the community, as well higher than the minimum necessary will procedures that enable nonprogram
as to the individual patient. serve to stimulate more rapid improvements providers to adhere to the ISTC. Such
The ISTC is also intended to facilitate in tuberculosis care worldwide. There are accommodations may be necessary, for
coordination of activities and collaboration many situations in which local conditions, example, to facilitate treatment supervision
between tuberculosis control programs and practices, and resources will support a level and contact investigations. In addition to
nonprogram providers. Given that public of care beyond what is described in the healthcare providers and government
health authorities are responsible for ISTC. To meet the requirements of the tuberculosis programs, both patients and
normative functions, surveillance, monitoring, ISTC, approaches and strategies determined communities are part of the intended
evaluation, and reporting, it is crucial that by local circumstances and practices, audience. Patients are increasingly aware of
there be coordination between control and developed in collaboration with local (and have the right to care that) measures
programs and nonprogram providers, and national public health authorities, up to a high standard. Having generally
especially in dealing with complicated issues, will be necessary. agreed upon standards will empower
such as diagnosis and management of There are several critical areas that are patients to evaluate the quality of care
patients with drug-resistant tuberculosis. beyond the scope of the document. The they are being provided. Good care for
The ISTC provides a common ground ISTC does not address access to care. individuals with tuberculosis is also in the
of understanding on which to build Obviously, if there is no care available, the best interest of the community. Community
collaborations at national, regional, or local quality of care is not relevant. In addition, contributions to tuberculosis care and
levels, or even within individual institutions. there are many factors that impede access, control are increasingly important in
It was stated in Edition 1 that, As even when care is available: poverty, sex, raising public awareness of the disease,
written, the Standards are presented within stigma, and geography are prominent providing treatment support, encouraging

Hopewell, Fair, and Uplekar: Updating International Standards for TB Care 283

adherence, reducing the stigma associated (23%), and Eastern Mediterranean region. ensure that the document reects the
with having tuberculosis, and demanding Of the responders, 90% (87% of whom perspectives of all sectors of the health care
that healthcare providers in the community were program managers and staff) had system and creates a sense of ownership of
adhere to a high standard of tuberculosis heard of the ISTC; of those who had heard and commitment to the principles and
care (33). The community should expect of the Standards, 85% said that they use the practices described in the ISTC.
that care for tuberculosis will be up to the ISTC, and 95% indicated that the ISTC
accepted standard and, thus, create was applicable and relevant to their work.
a demand for high-quality services. When asked how they have used the ISTC, The Future
79% said for developing national guidelines
or policies, 66% for education or training, It is anticipated that the pace of change in
Utilization 38% for engaging the private sector, 34% the tools available for tuberculosis care will
for monitoring and evaluation activities, continue to be rapid. For too long, the
The ISTC is potentially a very powerful tool and 28% for developing local guidelines science of tuberculosis has seemed to move
for improving the quality of tuberculosis or policies. Given that a primary purpose at a pace consistent with the slow replication
care. Because of the way in which the ISTC of the ISTC has always been to engage time of M. tuberculosis. Now, however,
was developed and the international the private sector, it was somewhat using rapid molecular methods and user-
endorsements that it has received through disappointing to learn that there was not friendly platforms, the speed with
the two previous editions, the document is greater utilization for this purpose. which the organism can be identied has
broadly credible across categories of However, it was encouraging to hear that been greatly accelerated. Hopefully, the
practitioners. This credibility is a major many respondents use the ISTC in science of new tools development and
strength of the ISTC, and should be developing national guidelines and policies. implementation will advance at this more
capitalized upon in its utilization. Since rapid rate. Although the principles of care
publication of the rst edition in 2006, the that underlie the ISTC will not change, the
ISTC has been endorsed by more than 50 Adaptation ways in which they are applied will evolve.
international and national organizations, A challenging aspect of the hoped for
including many medical professional The ISTC has been developed for a global evolution will be (already is) providing
societies, has been translated into at least audience, and it is expected and desirable rapid updates of guidance documents, such
15 languages, and has been used by many that regions and countries adapt the as the ISTC. To approach this challenge,
national tuberculosis control programs to document to suit their own circumstances. we intend to make the ISTC primarily an
guide the development of national program These circumstances include consideration electronic document, with applications
guidelines and policies. Endorsement by of the epidemiology of tuberculosis and through which updates can rapidly and
professional societies is particularly the facilities and resources available in both automatically be delivered. Through this
important in that they can serve to exert the public and private sectors. The ultimate and other yet-to-be-dened mechanisms,
peer pressure, both on their members and, goal of these adaptations should be to we hope to achieve the full engagement
when necessary, on government programs improve the quality of services for of all sectors of the healthcare system in
to adhere to the ISTC. Moreover, tuberculosis within a more limited setting. delivering high-quality tuberculosis
professional societies often provide the only For example, the ISTC has served as diagnostic, treatment, and preventive
systematic conduit through which to deliver a model framework for more locally services. n
practice recommendations. developed standards for the European
To inform future utilization of the Union and India (34, 35). Local adaptations Author disclosures are available with the text
ISTC, we conducted an online survey to have also been developed in Kenya and of this article at www.atsjournals.org.
ascertain the current awareness and usage Indonesia.
of the Standards (Editions 1 and 2). A link Ideally, a consultative process involving Acknowledgment: This article is copyrighted
by the World Health Organization, which has
to the survey was sent to the regional all relevant stakeholders should be granted the ATS permission for this publication.
advisors of the six WHO regions, and was undertaken to ensure that the adaptation The authors acknowledge important
disseminated from the regional ofces to of the ISTC is appropriate for the contributions from staff members of the World
119 national tuberculosis control programs. environment and provides appropriate Health Organization, Global Tuberculosis
Programme: Haileyesus Getahun, Chris Gilpin,
There was a 59% response rate (70/119), guidance for implementation of the Malgosia Grzemska, Ernesto Jaramillo, Knut
with the majority of responders coming practices described in the document. Lonnroth, Mario Raviglione, Diana Weil, and Karin
from the Americas (36%), European region Moreover, broad input is necessary to Weyer.

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