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

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dc.contributor.authorLessells, Richarden_ZA
dc.contributor.authorCooke, Grahamen_ZA
dc.contributor.authorMcGrath, Nualaen_ZA
dc.contributor.authorNicol, Marken_ZA
dc.contributor.authorNewell, Marie-Louiseen_ZA
dc.contributor.authorGodfrey-Faussett, Peteren_ZA
dc.date.accessioned2015-11-27T09:32:12Z
dc.date.available2015-11-27T09:32:12Z
dc.date.issued2013en_ZA
dc.description.abstractBACKGROUND: Tuberculosis control in sub-Saharan Africa has long been hampered by poor diagnostics and weak health systems. New molecular diagnostics, such as the Xpert(R) 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.en_ZA
dc.identifier.apacitationLessells, R., Cooke, G., McGrath, N., Nicol, M., Newell, M., & Godfrey-Faussett, P. (2013). 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. <i>Trials</i>, http://hdl.handle.net/11427/15388en_ZA
dc.identifier.chicagocitationLessells, Richard, Graham Cooke, Nuala McGrath, Mark Nicol, Marie-Louise Newell, and Peter Godfrey-Faussett "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." <i>Trials</i> (2013) http://hdl.handle.net/11427/15388en_ZA
dc.identifier.citationLessells, R. J., Cooke, G. S., McGrath, N., Nicol, M. P., Newell, M. L., & Godfrey-Faussett, P. (2013). 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, 14(1), 170.en_ZA
dc.identifier.ris TY - Journal Article AU - Lessells, Richard AU - Cooke, Graham AU - McGrath, Nuala AU - Nicol, Mark AU - Newell, Marie-Louise AU - Godfrey-Faussett, Peter AB - 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(R) 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. DA - 2013 DB - OpenUCT DO - 10.1186/1745-6215-14-170 DP - University of Cape Town J1 - Trials LK - https://open.uct.ac.za PB - University of Cape Town PY - 2013 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/15388 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15388
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-14-170
dc.identifier.vancouvercitationLessells R, Cooke G, McGrath N, Nicol M, Newell M, Godfrey-Faussett P. 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; http://hdl.handle.net/11427/15388.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDivision of Medical Biochemistryen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2013 Lessells et al.; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceTrialsen_ZA
dc.source.urihttp://www.trialsjournal.com/en_ZA
dc.subject.otherTuberculosisen_ZA
dc.subject.otherMultidrug-resistant tuberculosisen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherMolecular diagnosticsen_ZA
dc.subject.otherPoint-of-care systemsen_ZA
dc.subject.otherClinical trialen_ZA
dc.titleImpact 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 trialen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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