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.

Introduction

Purpose

The purpose of the International Standards
for Tuberculosis Care (ISTC) is to describe 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 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 tuberculosis
complex (M. tuberculosis) organisms,
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 present
what should be done, whereas, guidelines describe how the action is to be accomplished.
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 disease
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 circumstances.
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 individual
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; 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 responsibilities 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 tuberculosis and are 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. Adherence to the standards in this
document will enable these responsibilities to be fulfilled.
h4. 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 international
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 tuberculosis
control program lack the guidance and systematic evaluation of outcomes provided
by government control programs, and, commonly, would not be in compliance with
the Standards. Thus, although government program providers are not exempt from adherence
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 associated
with having tuberculosis, and demanding that healthcare providers in the community
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 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 tuberculosis 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.

To meet the requirements of the Standards, approaches and strategies (guidelines), determined
by local circumstances and practices and developed in collaboration with local
and national public health authorities, will be necessary. There are many situations in
which the level of care can, and should, go beyond what is specifi ed in the Standards.
Local conditions, practices, and resources also will determine the degree to which this is
the case.

The Standards are also intended to serve as a companion to and support for the Patients’
Charter for Tuberculosis Care (http://www.worldcarecouncil.org) developed in tandem
with the ISTC. This Charter 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.

There are several critical areas that the Standards do not address. Their exclusion should
not be regarded as an indication of their lack of importance but, rather, their being beyond
the scope of this document. The Standards do not address the extremely important concern
with overall access to care. Obviously, if there is no care available, the quality of care
is not relevant. Additionally, there are many factors that impede access even when care
is available: poverty, gender, stigma, and geography are prominent among the factors
that interfere with persons seeking or receiving care. Also, if the residents of a given area
perceive that the quality of care provided by the local facilities is substandard, they will not
seek care there. This perception of quality is a component of access that adherence to
the Standards will address.1

Also not addressed by the Standards is the necessity of having a sound, effective government
tuberculosis control program. The requirements of such programs are described in
a number of international recommendations from the WHO, the US Centers for Disease
Control and Prevention (CDC), and the International Union Against Tuberculosis and Lung
Disease (The Union). Having an effective control program at the national or local level with
linkages to non-program providers enables bidirectional communication of information including
case notifi cation, consultation, patient referral, provision of drugs or services such
as treatment supervision/support for private patients, and contact evaluation. In addition,
the program may be the only source of laboratory services to the private sector.
In providing care for patients with, or suspected of having, tuberculosis, clinicians and
persons responsible for healthcare facilities should take measures that reduce the potential
for transmission of M. tuberculosis to healthcare workers and to other patients by
following either local, national, or international guidelines for infection control. This is especially
true in areas or specifi c populations with a high prevalence of HIV infection. Detailed
recommendations are contained in the WHO Guidelines for Prevention of Tuberculosis in
Health Care Facilities in Resource-Limited Settings, and the updated CDC guidelines for
preventing the transmission of M. tuberculosis in healthcare settings.4,5
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. Within the
Standards, priorities may be set that will foster appropriate incremental changes. For example,
rather than expecting full implementation of all diagnostic elements at once, priorities
should be set based on local circumstances and capabilities. Pursuing this example, once
high-quality sputum smear microscopy is universally available, the fi rst priority activity to
be accomplished would be performing sputum cultures for persons suspected of having
tuberculosis but who have negative sputum smears, especially those in areas of high HIV
prevalence. The second priority would consist of obtaining cultures and drug susceptibility
testing for patients at high risk of having tuberculosis caused by drug-resistant organisms.
A third priority would be performing cultures for all persons suspected of having
tuberculosis. In some settings, as a fourth priority, drug susceptibility testing should be
performed for isolates of M. tuberculosis obtained from patients not responding to standardized
treatment regimens and, finally, for initial isolates from all patients.