Lessells R.J., Cooke G.S., McGrath N., Nicol M.P., Newell M.-L., Godfrey-Faussett P.
Department of Clinical Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom; Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa; Department of Infectious Disease, Imperial College, London, United Kingdom; Academic Unit of Primary Care and Population Sciences and Academic Unit of Social Sciences, University of Southampton, Southampton, United Kingdom; Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa; UCL Institute of Child Health, London, United Kingdom
Lessells, R.J., Department of Clinical Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom, Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa; Cooke, G.S., Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa, Department of Infectious Disease, Imperial College, London, United Kingdom; McGrath, N., Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa, Academic Unit of Primary Care and Population Sciences and Academic Unit of Social Sciences, University of Southampton, Southampton, United Kingdom; Nicol, M.P., Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa; Newell, M.-L., Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa, UCL Institute of Child Health, London, United Kingdom; Godfrey-Faussett, P., Department of Clinical Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom
Background: 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.Methods/Design: 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.Conclusion: 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.Trial registration: Current Controlled Trials ISRCTN18642314; South African National Clinical Trials Registry DOH-27-0711-3568. © 2013 Lessells et al.; licensee BioMed Central Ltd.
adult; article; binomial distribution; cluster analysis; comparative study; controlled study; health center; high risk patient; human; Human immunodeficiency virus infection; lung tuberculosis; molecular diagnostics; mortality; multidrug resistant tuberculosis; Mycobacterium tuberculosis; outcome assessment; randomized controlled trial; rural area; South Africa; sputum culture; treatment duration; univariate analysis; Ambulatory Care Facilities; Antitubercular Agents; Bacteriological Techniques; Clinical Protocols; Coinfection; HIV Infections; Humans; Laboratories; Logistic Models; Molecular Diagnostic Techniques; Mycobacterium tuberculosis; Point-of-Care Systems; Predictive Value of Tests; Primary Health Care; Research Design; Risk Assessment; Risk Factors; Rural Health Services; South Africa; Sputum; Time Factors; Tuberculosis, Multidrug-Resistant; Tuberculosis, Pulmonary