Standards for clinical trials for treating TB.

BACKGROUND: The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.METHODS: A global panel of experts participated in a Delphi process, using a 7-point Likert scale to score and revise draft standards until consensus was reached.RESULTS: Eleven standards were defined: Standard 1, high quality data on TB regimens are essential to inform clinical and programmatic management; Standard 2, the research questions addressed by TB trials should be relevant to affected communities, who should be included in all trial stages; Standard 3, trials should make every effort to be as inclusive as possible; Standard 4, the most efficient trial designs should be considered to improve the evidence base as quickly and cost effectively as possible, without compromising quality; Standard 5, trial governance should be in line with accepted good clinical practice; Standard 6, trials should investigate and report strategies that promote optimal engagement in care; Standard 7, where possible, TB trials should include pharmacokinetic and pharmacodynamic components; Standard 8, outcomes should include frequency of disease recurrence and post-treatment sequelae; Standard 9, TB trials should aim to harmonise key outcomes and data structures across studies; Standard 10, TB trials should include biobanking; Standard 11, treatment trials should invest in capacity strengthening of local trial and TB programme staff.CONCLUSION: These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.

The second sputum sample complicates tuberculosis diagnosis for women: a qualitative study from Malawi.

SETTING: District hospital and peripheral health care facilities in Balaka District, Malawi. OBJECTIVE: To identify barriers encountered by women in submitting a second sputum sample. DESIGN: Focus-group discussions and semi-structured interviews. RESULTS: Women encounter barriers at several levels: personal, cultural, socio-economic and health care system. Personal, cultural and socio-economic barriers include the fear of a tuberculosis (TB) diagnosis, the perception and condition of the patient, the distance and cost of travel to a health care facility, the subordinate position of women in household decision-making and the social support that women receive. Barriers at the health care system level include high patient numbers, staff shortages, the duration of the TB diagnostic process as well as the uncaring attitude and poor communication of health care workers. These barriers may apply not only to the submission of the second sample, but to health care access in general. CONCLUSION: Women face multiple barriers in submitting a second sputum sample. These do not operate in isolation but instead compound each other. Although potential solutions to overcome these barriers are recognised, some have yet to be adopted. To improve TB case finding, innovative and community approaches should be adopted more rapidly.

Public health advocacy for the Berlin Declaration on tuberculosis in the former Soviet Union: The view of Médecins Sans Frontières.

To assist international efforts to address major gaps in the availability and accessibility of quality diagnosis and treatment for multi-drug resistant tuberculosis, Médecins Sans Frontières has adapted an approach combining three sets of interlinked strategies: direct provision of medical care, operational research, and public health advocacy. The activities undertaken are reviewed each in turn, with stress on the ways that they impact upon and consolidate each other. In spite of new opportunities, including technologies which significantly improve diagnosis and new, more patient-centred approaches, a much broader international mobilization is needed in order to confront MDR-TB. It is also questionable as to whether existing technologies are successful enough to provide a solid basis for expanded national programs.