Setting international standards for TB care

Prof. G B Migliori is co-ordinating several national and international research projects on TB and asthma control for the Italian Ministry of Health, the World Health Organisation and the IUATLD (International Union Against Tuberculosis and Lung Disease).
His experience and activities in the field are too extensive to list. They include important contributions to the new Ugandan National Health Information System. Since 1995, he has been a Consultant of the World Health Organisation (in charge of TB control) with significant contributions to approaches in Russia, Romania, the Ukraine, Moldova, Turkey, Kosovo, Estonia, Mozambique and Italy.
In 2000, he became Director of the WHO Collaborating Centre for Tuberculosis and Lung Diseases and, from 2003, Head of the Clinical Epidemiology Service of Respiratory Disease, Fondazione Salvatore Maugeri, Care & Research Institute, Tradate, in Italy.
Prof. Migliori is presently co-ordinating several national and international research projects on TB and asthma control for the Italian Ministry of Health, the WHO and the IUATLD (International Union Against Tuberculosis and Lung Disease).
He is the author of the European Guidelines for TB control and co-author of the main guidelines on TB control resulting from the IUATLD/WHO workshops (Wolfheze documents), and is Associate Editor of the European Respiratory Journal, and prolific contributor to other specialist journals.

Principles of tuberculosis control and elimination
TB control is a public health function aimed at reducing the transmission of TB bacilli in the general population. Presently, at global level the TB notification rate is still growing at an average 1% per year, largely the result of the constant increase of cases in sub-Saharan Africa and, to a lesser extent, in the former Soviet Union with a significant prevalence of multi-drug-resistant (MDR –TB) and extensively drug resistant  (XDR-TB) cases.

XDR-TB is a new, severe form of TB presently defined as resistant to at least rifampicin and isoniazid (which is the definition of MDR-TB), in addition to any fluoroquinolone, and to at least one of these three injectable drugs used in anti-TB treatment: capreomycin, kanamycin and amikacin.
In January 2006 the new Global Plan to Stop TB, 2006-2015 was launched. The plan, underpinned by the Stop TB Strategy, describes strategies, financial requirements and existing gaps to reach the Millennium Developments Goals (MDGs) in all regions of the world.

The new Stop TB Strategy for Tuberculosis Control and its contribution to control and eliminate tuberculosis
The DOTS strategy (composed of five key elements: government commitment, diagnosis through sputum smear microscopy, standardised and supervised treatment, uninterrupted drug supply, and regular programme monitoring) has greatly contributed to improved global TB control over the last 10 years.
However, due to a variety of reasons, DOTS has not been sufficient to control the epidemic in the two regions of Africa and Eastern Europe. This is why the new Stop TB Strategy promoted by the World Health Organisation, while keeping DOTS as the first and foremost of its six components, has made explicit five additional components that must be implemented to reach the 2015 MDGs relevant to TB: 1) pursue high-quality DOTS expansion and enhancement; 2) address TB/HIV, MDR-TB and other challenges; 3) contribute to health system strengthening; 4) engage all care providers; 5) empower people with TB and communities; 6) enable and promote research.

International standards for TB care
The International Standards for Tuberculosis Care (ISTC) have been developed as a tool that can be used to improve the quality of care across all providers, public and private. The ISTC are intended to facilitate the effective delivery of high-quality care for all patients regardless of age or gender, and including the ‘complicated’ cases, those who are sputum smear-negative, have extra-pulmonary 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.  The document includes six standards for diagnosis, nine standards for treatment and two standards addressing public health responsibilities.
The ISTC emphasises, among other issues, that TB diagnosis should be promptly and adequately established, based, whenever possible, on bacteriological evidence. Standardised treatment regimens of proven quality should be prescribed, with appropriate treatment support and supervision. The response to treatment should be monitored and microbiological examinations performed. The essential public health responsibilities should be carried out, including evaluation and management of close contacts as well as case notification and reporting of treatment outcomes.

ISTC, private sector and scientific societies
Although the ISTC is evidence-based and widely accepted, it is only a tool, not an end in itself. To achieve adherence to the standards in the ISTC it is critical that they have sufficient ‘weight’ to wield influence and be disseminated to relevant practitioners. This can best be achieved by having broad endorsement of influential medical and nursing professional societies, both national and international and that these societies then 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 (PPM) DOTS approaches.

Conclusions
The epidemiologic evidence indicates the specific new challenges for tuberculosis control in Europe. The ISTC document is aimed at stimulating the global effort in the fight against tuberculosis starting from the quality management of each individual patient by each individual physician.
Contact: gbmigliori@fsm.it

31.08.2007