Improving the TB case management: the International Standards for Tuberculosis care

Tuberculosis (TB) is currently the leading cause of death from a curable infectious disease 1. The World Health Organization (WHO) estimates that 8.9 million new TB cases occurred in 2004 (of which 3.9 million were sputum smear positive), although only about half of the estimated number were reported by public health systems 1, 2.

Whilst the highest TB incidence rate is in sub-Saharan Africa (estimated to be 356 new cases per 100,000 population per yr), in most countries of the former Soviet Union the estimated incidence rate exceeds 100 new cases per 100,000 population per yr 1, 2.

Although the rate of increase in the TB incidence rate is decreasing, the global TB notification grew by 1% between 2003 and 2004, the last year for which data are available. This continued increase is largely the result of the striking increase in cases in sub-Saharan Africa and, to a lesser extent, in the former USSR. Whilst the worsening of the TB incidence in Africa is due to the HIV epidemic compounded by an insufficient health infrastructure, it is due to different causes in Eastern Europe, including economic decline, increased poverty, social disruption and sub-standard health services. In addition, as a result of these factors, >10% of new TB cases in the Baltic states and in some parts of Russia are multidrug-resistant (MDR-TB), i.e. resistant to at least isoniazid and rifampicin 3.

In the European region, 445,000 new TB cases and nearly 70,000 deaths were estimated to have resulted from TB in 2004. In the Eastern part of the region, the levels of directly observed treatment, short-course (DOTS) strategy coverage and case detection are the lowest among the world regions, and the overall treatment success rate is the second lowest (75%) after Africa 2.

THE NEW STOP TB STRATEGY FOR TB CONTROL

The DOTS strategy (composed of five key elements: government commitment, bacteriological diagnosis, standardised and supervised treatment, uninterrupted drug supply, and regular programme monitoring) has greatly contributed to improved global TB control during the past decade 4, 5. As of the end of 2004, 183 countries had adopted DOTS, and the latest performance assessments show that the global case detection rate was 53% (cases notified/estimated number of cases) in 2004, and the percentage of patients treated successfully was 82% in the 2003 cohort.

Several examples of country success stories have been reported, including China (significant reduction in the prevalence of pulmonary, smear-positive and culture-positive TB) 6, Peru (incidence of TB declining 6% per annum after DOTS introduction) 7, India (600,000 additional lives saved during the first 8 yrs of DOTS implementation), Cuba, Tanzania and Malawi among others 4.

However, for a variety of reasons, DOTS has not been sufficient to control the epidemic in sub-Saharan Africa or Eastern Europe. To address these and other challenges to TB care and control, the WHO developed a broader approach that is embodied in the new Stop TB Strategy. The new strategy, while keeping DOTS as the first and foremost of its six components 5, has made explicit five additional components that must be implemented to reach the 2015 Millennium Development Goals relevant to TB. These have the following aims: 1) to pursue high-quality DOTS expansion and enhancement; 2) to address TB/HIV, MDR-TB and other challenges; 3) to contribute to health system strengthening; 4) to engage all care providers; 5) to empower people with TB, and communities; and 6) to enable and promote research.

Within these six components, the engagement of all care providers is of utmost importance and deserves emphasis. Many patients with symptoms caused by what ultimately is proven to be TB initially seek care in the private sector and many private providers both diagnose and treat the disease. Relying solely on governmental services in many areas greatly limits TB control efforts. Since prompt, accurate diagnosis and effective treatment to cure are the core elements of TB control, it is essential that all practitioners who provide TB services do so in an effective manner in conformance with international standards.

THE INTERNATIONAL STANDARDS FOR TUBERCULOSIS CARE

The International Standards for Tuberculosis Care (ISTC) document 8 has been developed as a tool that can be used to unify public and private sectors in providing high-quality care for TB. The ISTC is intended to facilitate the effective delivery of high-quality care for all patients regardless of age or sex, including the “complicated” cases, i.e. those who are sputum smear negative, have extrapulmonary sites of disease, and those who are affected by MDR-TB or co-infected with HIV. They are designed to put the patient at the centre of care and the healthcare provider at the centre of TB control. As summarised in table 1⇓, the document includes six standards for diagnosis, nine standards for treatment and two standards addressing public health responsibilities.

As accurate diagnosis and effective treatment are the core of both TB care and TB control, any clinician providing TB services to individual patients is, by definition, assuming an important public health function as well as providing individual patient care. Thus, at the centre of the ISTC is the notion of both individual and public health responsibility. The ISTC emphasises that TB diagnosis should be promptly and adequately established, based, whenever possible, on bacteriological evidence. Internationally recommended treatment regimens of proven quality should be prescribed, using the recommended doses, and for the recommended duration, with appropriate treatment support and supervision. The response to treatment should be monitored and microbiological examinations performed after the initial intensive phase of treatment, after 5 months and at the end of treatment. The essential public health responsibilities are to be fully satisfied, including evaluation and management of close contacts, as well as case notification and reporting of new cases and treatment outcomes.

The ISTC, in underlining the importance of these essential care operations, is fully consistent with WHO recommendations, as described in a number of guidelines published over the years, and complementary to local and national TB control policies. The ISTC document is also consistent with European Respiratory Society guidelines 9, 10.

Although the ISTC is evidence based and widely accepted, it is only a tool, not an end in itself. To achieve adherence to the ISTC, it is critical that it has sufficient “weight” to wield influence and that it is disseminated to relevant practitioners. This can best be achieved by having the broad endorsement of influential medical and nursing professional societies, both national and international, and that these societies develop educational activities based on the ISTC. Of key importance is the close collaboration with the national TB programme and the synergistic attempt to include the ISTC among the basic tools required for the proper implementation of public–private mix DOTS approaches.

Each healthcare provider in Europe (chest physicians and infectious disease specialists, in particular) should have a copy of the ISTC on his/her desk, hopefully translated by an appropriate national professional society or national programme in his/her native language. This will help to improve the quality of care of all TB cases and increase the proportion of cases successfully treated, while, at the same time, achieve the national programme targets for TB control.

The complete English versions of the International Standards for Tuberculosis Care and The Patients' Charter for Tuberculosis Care (outlining the rights and responsibilities of people with tuberculosis) are available at www.worldcarecouncil.org.