Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial

 

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dc.contributor.author Cox, Helen S en_ZA
dc.contributor.author Mbhele, Slindile en_ZA
dc.contributor.author Mohess, Neisha en_ZA
dc.contributor.author Whitelaw, Andrew en_ZA
dc.contributor.author Muller, Odelia en_ZA
dc.contributor.author Zemanay, Widaad en_ZA
dc.contributor.author Little, Francesca en_ZA
dc.contributor.author Azevedo, Virginia en_ZA
dc.contributor.author Simpson, John en_ZA
dc.contributor.author Boehme, Catharina C en_ZA
dc.contributor.author Nicol, Mark P en_ZA
dc.date.accessioned 2015-12-28T06:51:41Z
dc.date.available 2015-12-28T06:51:41Z
dc.date.issued 2014 en_ZA
dc.identifier.citation Cox, H. S., Mbhele, S., Mohess, N., Whitelaw, A., Muller, O., Zemanay, W., ... & Nicol, M. P. (2014). Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial. PLoS Med, 11(11), e1001760. doi:10.1371/journal.pmed.1001760 en_ZA
dc.identifier.uri http://hdl.handle.net/11427/16068
dc.identifier.uri http://dx.doi.org/10.1371/journal.pmed.1001760
dc.description.abstract Background: Xpert MTB/RIF is approved for use in tuberculosis (TB) and rifampicin-resistance diagnosis. However, data are limited on the impact of Xpert under routine conditions in settings with high TB burden. Methods and Findings: A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive (symptomatic) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic. The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by 3 mo after presentation. Secondary outcomes included time to TB treatment and mortality. Unblinded randomisation occurred on a weekly basis. Xpert and smear microscopy were performed on site. Analysis was both by intention to treat (ITT) and per protocol. Between 7 September 2010 and 28 October 2011, 1,985 participants were assigned to the Xpert (n = 982) and routine (n = 1,003) diagnostic algorithms (ITT analysis); 882 received Xpert and 1,063 routine (per protocol analysis). 13% (32/257) of individuals with bacteriologically confirmed TB (smear, culture, or Xpert) did not initiate treatment by 3 mo after presentation in the Xpert arm, compared to 25% (41/167) in the routine arm (ITT analysis, risk ratio 0.51, 95% CI 0.33–0.77, p = 0.0052). The yield of bacteriologically confirmed TB cases among patients with presumptive TB was 17% (167/1,003) with routine diagnosis and 26% (257/982) with Xpert diagnosis (ITT analysis, risk ratio 1.57, 95% CI 1.32–1.87, p<0.001). This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm: 23% (229/1,003) and 28% (277/982) in the routine and Xpert arms, respectively (ITT analysis, risk ratio 1.24, 95% CI 1.06–1.44, p = 0.013). Time to treatment initiation was improved overall (ITT analysis, hazard ratio 0.76, 95% CI 0.63–0.92, p = 0.005) and among HIV-infected participants (ITT analysis, hazard ratio 0.67, 95% CI 0.53–0.85, p = 0.001). There was no difference in 6-mo mortality with Xpert versus routine diagnosis. Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic. Conclusions: These data suggest that in this routine primary care setting, use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by 3 mo and reduced time to treatment initiation, particularly among HIV-infected participants. en_ZA
dc.language.iso eng en_ZA
dc.publisher Public Library of Science en_ZA
dc.rights This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. en_ZA
dc.rights.uri http://creativecommons.org/licenses/by/4.0 en_ZA
dc.source PLOS Medicince en_ZA
dc.source.uri http://journals.plos.org/plosmedicine en_ZA
dc.subject.other Tuberculosis en_ZA
dc.subject.other Tuberculosis diagnosis and management en_ZA
dc.subject.other Mycobacterium tuberculosis en_ZA
dc.subject.other Sputum en_ZA
dc.subject.other Diagnostic medicine en_ZA
dc.subject.other HIV diagnosis and management en_ZA
dc.subject.other HIV en_ZA
dc.subject.other Extensively drug-resistant tuberculosis en_ZA
dc.title Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial en_ZA
dc.type Journal Article en_ZA
dc.rights.holder © 2014 Cox et al en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Division of Medical Biochemistry en_ZA
uct.type.filetype Text
uct.type.filetype Image
dc.identifier.apacitation Cox, H. S., Mbhele, S., Mohess, N., Whitelaw, A., Muller, O., Zemanay, W., ... Nicol, M. P. (2014). Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial. <i>PLOS Medicince</i>, http://hdl.handle.net/11427/16068 en_ZA
dc.identifier.chicagocitation Cox, Helen S, Slindile Mbhele, Neisha Mohess, Andrew Whitelaw, Odelia Muller, Widaad Zemanay, Francesca Little, et al "Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial." <i>PLOS Medicince</i> (2014) http://hdl.handle.net/11427/16068 en_ZA
dc.identifier.vancouvercitation Cox HS, Mbhele S, Mohess N, Whitelaw A, Muller O, Zemanay W, et al. Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial. PLOS Medicince. 2014; http://hdl.handle.net/11427/16068. en_ZA
dc.identifier.ris TY - Journal Article AU - Cox, Helen S AU - Mbhele, Slindile AU - Mohess, Neisha AU - Whitelaw, Andrew AU - Muller, Odelia AU - Zemanay, Widaad AU - Little, Francesca AU - Azevedo, Virginia AU - Simpson, John AU - Boehme, Catharina C AU - Nicol, Mark P AB - Background: Xpert MTB/RIF is approved for use in tuberculosis (TB) and rifampicin-resistance diagnosis. However, data are limited on the impact of Xpert under routine conditions in settings with high TB burden. Methods and Findings: A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive (symptomatic) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic. The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by 3 mo after presentation. Secondary outcomes included time to TB treatment and mortality. Unblinded randomisation occurred on a weekly basis. Xpert and smear microscopy were performed on site. Analysis was both by intention to treat (ITT) and per protocol. Between 7 September 2010 and 28 October 2011, 1,985 participants were assigned to the Xpert (n = 982) and routine (n = 1,003) diagnostic algorithms (ITT analysis); 882 received Xpert and 1,063 routine (per protocol analysis). 13% (32/257) of individuals with bacteriologically confirmed TB (smear, culture, or Xpert) did not initiate treatment by 3 mo after presentation in the Xpert arm, compared to 25% (41/167) in the routine arm (ITT analysis, risk ratio 0.51, 95% CI 0.33–0.77, p = 0.0052). The yield of bacteriologically confirmed TB cases among patients with presumptive TB was 17% (167/1,003) with routine diagnosis and 26% (257/982) with Xpert diagnosis (ITT analysis, risk ratio 1.57, 95% CI 1.32–1.87, p<0.001). This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm: 23% (229/1,003) and 28% (277/982) in the routine and Xpert arms, respectively (ITT analysis, risk ratio 1.24, 95% CI 1.06–1.44, p = 0.013). Time to treatment initiation was improved overall (ITT analysis, hazard ratio 0.76, 95% CI 0.63–0.92, p = 0.005) and among HIV-infected participants (ITT analysis, hazard ratio 0.67, 95% CI 0.53–0.85, p = 0.001). There was no difference in 6-mo mortality with Xpert versus routine diagnosis. Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic. Conclusions: These data suggest that in this routine primary care setting, use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by 3 mo and reduced time to treatment initiation, particularly among HIV-infected participants. DA - 2014 DB - OpenUCT DO - 10.1371/journal.pmed.1001760 DP - University of Cape Town J1 - PLOS Medicince LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 T1 - Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial TI - Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial UR - http://hdl.handle.net/11427/16068 ER - en_ZA


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This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Except where otherwise noted, this item's license is described as This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.