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Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial
Trials, 2013-06, Vol.14 (1), p.170-170
2013

Details

Autor(en) / Beteiligte
Titel
Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial
Ist Teil von
  • Trials, 2013-06, Vol.14 (1), p.170-170
Ort / Verlag
England: BioMed Central Ltd
Erscheinungsjahr
2013
Link zum Volltext
Quelle
SpringerLink (Online service)
Beschreibungen/Notizen
  • Tuberculosis control in sub-Saharan Africa has long been hampered by poor diagnostics and weak health systems. New molecular diagnostics, such as the Xpert® MTB/RIF assay, have the potential to improve patient outcomes. We present a cluster randomised trial designed to evaluate whether the positioning of this diagnostic system within the health system has an impact on important patient-level outcomes. This pragmatic cluster randomised clinical trial compared two positioning strategies for the Xpert MTB/RIF system: centralised laboratory versus primary health care clinic. The cluster (unit of randomisation) is a 2-week time block at the trial clinic. Adult pulmonary tuberculosis suspects with confirmed human immunodeficiency virus infection and/or at high risk of multidrug-resistant tuberculosis are enrolled from the primary health care clinic. The primary outcome measure is the proportion of culture-confirmed pulmonary tuberculosis cases initiated on appropriate treatment within 30 days of initial clinic visit. Univariate logistic regression will be performed as the primary analysis using generalised estimating equations with a binomial distribution function and a logit link. Diagnostic research tends to focus only on performance of diagnostic tests rather than on patient-important outcomes. This trial has been designed to improve the quality of evidence around diagnostic strategies and to inform the scale-up of new tuberculosis diagnostics within public health systems in high-burden settings. Current Controlled Trials ISRCTN18642314; South African National Clinical Trials Registry DOH-27-0711-3568.
Sprache
Englisch
Identifikatoren
ISSN: 1745-6215
eISSN: 1745-6215
DOI: 10.1186/1745-6215-14-170
Titel-ID: cdi_biomedcentral_primary_oai_biomedcentral_com_1745_6215_14_170
Format
–
Schlagworte
Ambulatory Care Facilities, Antitubercular Agents - therapeutic use, Bacteriological Techniques, Clinical Protocols, Coinfection, Control, Diagnosis, Drug resistance in microorganisms, Epidemics, HIV (Viruses), HIV infection, HIV Infections - mortality, Humans, Laboratories, Logistic Models, Molecular Diagnostic Techniques, Mycobacterium tuberculosis - growth & development, Mycobacterium tuberculosis - isolation & purification, Patient outcomes, Point-of-Care Systems, Predictive Value of Tests, Primary Health Care, Research Design, Risk Assessment, Risk Factors, Rural Health Services, South Africa, South Africa - epidemiology, Sputum - microbiology, Study Protocol, Time Factors, Tuberculosis, Tuberculosis, Multidrug-Resistant - diagnosis, Tuberculosis, Multidrug-Resistant - drug therapy, Tuberculosis, Multidrug-Resistant - microbiology, Tuberculosis, Multidrug-Resistant - mortality, Tuberculosis, Pulmonary - diagnosis, Tuberculosis, Pulmonary - drug therapy, Tuberculosis, Pulmonary - microbiology, Tuberculosis, Pulmonary - mortality, Virus diseases

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