Review
International Standards for Tuberculosis Care

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Summary

Part of the reason for failing to bring about a more rapid reduction in tuberculosis incidence worldwide is the lack of effective involvement of all practitioners—public and private—in the provision of high quality tuberculosis care. While health-care providers who are part of national tuberculosis programmes have been trained and are expected to have adopted proper diagnosis, treatment, and public-health practices, the same is not likely to be true for non-programme providers. Studies of the performance of the private sector conducted in several different parts of the world suggest that poor quality care is common. The basic principles of care for people with, or suspected of having, tuberculosis are the same worldwide: a diagnosis should be established promptly; standardised treatment regimens should be used with appropriate treatment support and supervision; response to treatment should be monitored; and essential public-health responsibilities must be carried out. Prompt and accurate diagnosis, and effective treatment are essential for good patient care and tuberculosis control. All providers who undertake evaluation and treatment of patients with tuberculosis must recognise that not only are they delivering care to an individual, but they are also assuming an important public-health function. The International Standards for Tuberculosis Care (ISTC) describe a widely endorsed level of care that all practitioners should seek to achieve in managing individuals who have, or are suspected of having, tuberculosis. The document is intended to engage all care providers in delivering high quality care for patients of all ages, including those with smear-positive, smear-negative, and extra-pulmonary tuberculosis, tuberculosis caused by drug-resistant Mycobacterium tuberculosis complex, and tuberculosis combined with HIV infection.

Introduction

In the past decade there has been substantial progress in the development and implementation of the strategies necessary for effective tuberculosis control. However, the disease remains an enormous and growing global health problem.1, 2, 3 Part of the reason for failing to achieve a more rapid reduction in tuberculosis incidence—even though the means to do so are well established, widely available, and embodied in the internationally recommended directly observed treatment, short course (DOTS) strategy—is the lack of involvement of practitioners outside of public-health tuberculosis control programmes in the provision of high quality tuberculosis care, in coordination with local and national control programmes.

Studies of the performance of the private sector conducted in different parts of the world suggest that poor quality care is common.4, 5, 6, 7, 8, 9, 10, 11, 12, 13 Clinicians—in particular those who work in the private health-care sector—often deviate from standard, internationally recommended, tuberculosis management practices.11, 13 These deviations include under-use of sputum smear microscopy for diagnosis (figure 1), generally associated with over-reliance on radiography; use of non-recommended drug regimens with incorrect combinations of drugs; mistakes in both drug dose and duration of treatment; and failure to supervise and assure adherence to treatment.5, 6, 7, 8, 9, 10, 11, 12, 13

Full engagement of all care providers through various forms of public–private and public–public partnerships is an important component of both WHO's expanded strategy for tuberculosis control,14 and the Global Plan to Stop TB, 2006–2015.15 Although there have been several approaches developed for involvement of the private sector (as well as for government employed providers who are not affiliated with a tuberculosis control programme), there has been no generally agreed upon set of standards describing the essential actions that should be taken by all practitioners in providing tuberculosis services. To address this shortcoming, the International Standards for Tuberculosis Care (ISTC; panel 1)16 were developed through a year-long inclusive process guided by a 28-member steering committee. The steering committee included individuals who represented a wide variety of relevant perspectives on tuberculosis care and control (see listing at the end of the paper). In addition, the document was presented at various public forums with an open invitation for comments. Several individuals and organisations had substantive comments, all of which were considered seriously, although not all were included in the document. It should be noted that in tandem with the development of the ISTC, a group of patient activists and advocates developed the Patients' Charter for Tuberculosis Care,17 describing patients' rights and responsibilities. There was considerable interaction between the two groups during the course of drafting the documents.

The purpose of ISTC is to describe a widely endorsed (an up-to-date list of endorsers can be found at http://www.stoptb.org) 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 ISTC differ from existing guidelines in that they describe what should be done, whereas guidelines describe how the action is to be accomplished. The ISTC are not intended to replace either WHO or local guidelines and were written to accommodate local differences in practice. The main target audience for the ISTC is the broad group of health-care professionals who provide diagnostic and treatment services for tuberculosis outside of government tuberculosis programmes.

It is anticipated that the ISTC will be used as a tool to unify approaches to tuberculosis care between public (at least government tuberculosis control programmes) and private providers. Although the standards themselves should not be modified based on local circumstances, clearly there will need to be local approaches to their use and implementation. Professional medical societies are very influential in many countries, and can serve as a conduit through which the standards can be disseminated. Moreover, professional societies can serve to exert peer pressure both on their members and, when necessary, on government programmes to adhere to the ISTC. Another anticipated use of the ISTC is to serve as a focus of curricula for medical, nursing, and allied health students as well as for in-service education. There are many elements that are necessary for tuberculosis care and control to be optimally effective. These include patient and community awareness, engagement and mobilisation; access to care; availability of quality assured laboratories; appropriate information systems; and adequate primary services and health systems in general.14 Although these elements are of substantial importance, they are beyond the scope of this set of standards, but are addressed in several other documents, particularly by the new Stop TB Strategy.14 We anticipate that as new information emerges these standards will change. The ISTC are envisioned as a living document that will be undergoing regular review and revision.

The ISTC apply to patients of all ages, including those with smear-positive, smear-negative, and extra-pulmonary tuberculosis, tuberculosis caused by drug-resistant Mycobacterium tuberculosis complex organisms, and tuberculosis combined with HIV infection. A high standard of care is essential for all forms of tuberculosis to restore the health of individuals, to prevent the disease in their families and others with whom they come into contact, and to protect the health of communities.4 The ISTC focus on the contribution that good clinical care of individual patients with, or suspected of having, tuberculosis can make to population-based tuberculosis control. A balanced approach emphasising both individual patient care and public-health principles of disease control is essential to reduce the effects on human health and economic losses caused by tuberculosis.

The basic principles of care for people with, or suspected of having, tuberculosis are the same worldwide: a diagnosis should be established promptly and accurately; standardised treatment regimens of proven efficacy should be used, together with appropriate treatment support and supervision; the response to treatment should be monitored; and the essential public-health responsibilities must be carried out. Prompt and accurate diagnosis and effective treatment are not only essential for good patient care, they are also the key elements in the public-health response to tuberculosis. Thus, all providers who undertake evaluation and treatment of patients with tuberculosis must recognise that as well as delivering care to an individual, they are also assuming an important public-health function that entails a high level of responsibility to the community, as well as to the individual patient.

Section snippets

Standard 1

All persons with otherwise unexplained productive cough lasting 2–3 weeks or more should be evaluated for tuberculosis.

Standard 7

Any practitioner treating a patient for tuberculosis is assuming an important public-health responsibility. To fulfil this responsibility the practitioner must not only prescribe an appropriate regimen, but also be capable of assessing 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 16

All providers of care for patients with tuberculosis should ensure that people (especially children under 5 years of age and those with HIV infection) who are in close contact with patients who have infectious tuberculosis are evaluated and managed in line with international recommendations. Children under 5 years of age and people 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.

Search strategy and selection criteria

Evidence summaries for each of the standards were generated by using several approaches. First, where available, existing systematic reviews (only English language) on all aspects of tuberculosis diagnosis and treatment were identified by a comprehensive search of PubMed and the Cochrane Library (both searches were up to date as of January, 2006). Second, existing evidence-based tuberculosis guidelines and recommendations were identified and compiled (a list of all the tuberculosis

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