Effect of Xpert MTB/RIF on clinical outcomes in routine care settings : individual patient data meta-analysis

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dc.contributor.authorDi Tanna, Gian Lucaen_ZA
dc.contributor.authorKhaki, Ali Razaen_ZA
dc.contributor.authorTheron, Granten_ZA
dc.contributor.authorMcCarthy, Kerriganen_ZA
dc.contributor.authorCox, Helenen_ZA
dc.contributor.authorMupfumi, Lucyen_ZA
dc.contributor.authorTrajman, Aneteen_ZA
dc.contributor.authorMason, Peteren_ZA
dc.contributor.authorBandason, Tsitsien_ZA
dc.contributor.authorDurovni, Betinaen_ZA
dc.contributor.authorBara, Wilberten_ZA
dc.contributor.authorHoelscher, Michaelen_ZA
dc.contributor.authorClowes, Petraen_ZA
dc.contributor.authorMangu, Chachaen_ZA
dc.contributor.authorChanda, Duncanen_ZA
dc.contributor.authorPym, Alexanderen_ZA
dc.contributor.authorMwaba, Peteren_ZA
dc.contributor.authorCobelens, Franken_ZA
dc.contributor.authorNicol, Mark P.en_ZA
dc.contributor.authorDheda, Keertanen_ZA
dc.contributor.authorChurchyard, Gavinen_ZA
dc.contributor.authorFielding, Katherineen_ZA
dc.contributor.authorMetcalfe, John Z.en_ZA
dc.date.accessioned2021-10-11T13:48:11Z
dc.date.available2021-10-11T13:48:11Z
dc.date.issued2019-02
dc.descriptionCITATION: Di Tanna, G. L., et al. 2019. Effect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis. The Lancet Global Health, 7(2):E191-E199. doi:10.1016/S2214-109X(18)30458-3
dc.descriptionThe original publication is available at https://www.thelancet.com/journals/langlo/home
dc.description.abstractBackground: Xpert MTB/RIF, the most widely used automated nucleic acid amplification test for tuberculosis, is available in more than 130 countries. Although diagnostic accuracy is well documented, anticipated improvements in patient outcomes have not been clearly identified. We performed an individual patient data meta-analysis to examine improvements in patient outcomes associated with Xpert MTB/RIF. Methods: We searched PubMed, Embase, ClinicalTrials.gov, and the Pan African Clinical Trials Registry from inception to Feb 1, 2018, for randomised controlled trials (RCTs) comparing the use of Xpert MTB/RIF with sputum smear microscopy as tests for tuberculosis diagnosis in adults (aged 18 years or older). We excluded studies of patients with extrapulmonary tuberculosis, and studies in which mortality was not assessed. We used a two-stage approach for our primary analysis and a one-stage approach for the sensitivity analysis. To assess the primary outcome of cumulative 6-month all-cause mortality, we first performed logistic regression models (random effects for cluster randomised trials, with robust SEs for multicentre studies) for each trial, and then pooled the odds ratio (OR) estimates by a fixed-effects (inverse variance) or random-effects (Der Simonian Laird) meta-analysis. We adjusted for age and gender, and stratified by HIV status and previous tuberculosis-treatment history. The study protocol has been registered with PROSPERO, number CRD42014013394. Findings Our search identified 387 studies, of which five RCTs were eligible for analysis. 8567 adult clinic attendees (4490 [63·5%] of 7074 participants for whom data were available were HIV-positive) were tested for tuberculosis with Xpert MTB/RIF (Xpert group) versus sputum smear microscopy (sputum smear group), across five low-income and middle-income countries (South Africa, Brazil, Zimbabwe, Zambia, and Tanzania). The primary outcome (reported in three studies) occurred in 182 (4·5%) of 4050 patients in the Xpert group and 217 (5·3%) of 4093 patients in the smear group (pooled adjusted OR 0·88, 95% CI 0·68–1·14 [p=0·34]; for HIV-positive individuals OR 0·83, 0·65–1·05 [p=0·12]). Kaplan-Meier estimates showed a lower rate of death (12·73 per 100 person-years in the Xpert group vs 16·38 per 100 person-years in the sputum smear group) for HIV-positive patients (hazard ratio 0·76, 95% CI 0·60–0·97; p=0·03). The risk of bias was assessed as reasonable and the statistical heterogeneity across studies was low (I²<20% for the primary outcome). Interpretation Despite individual patient data analysis from five RCTs, we were unable to confidently rule in nor rule out an Xpert MTB/RIF-associated reduction in mortality among outpatients tested for tuberculosis. Reduction in mortality among HIV-positive patients in a secondary analysis suggests the possibility of population-level impact.en_ZA
dc.description.urihttps://www.thelancet.com/journals/langlo/article/PIIS2214-109X(18)30458-3/fulltext
dc.description.versionPublisher’s version
dc.format.extent9 pagesen_ZA
dc.identifier.citationDi Tanna, G. L., et al. 2019. Effect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis. The Lancet Global Health, 7(2):E191-E199. doi:10.1016/S2214-109X(18)30458-3
dc.identifier.issn2214-109X (online)
dc.identifier.otherdoi:10.1016/S2214-109X(18)30458-3
dc.identifier.urihttp://hdl.handle.net/10019.1/123204
dc.language.isoen_ZAen_ZA
dc.publisherElsevieren_ZA
dc.rights.holderAuthors retain rightsen_ZA
dc.subjectTuberculosisen_ZA
dc.subjectMedicine -- Research -- Evaluationen_ZA
dc.subjectPatient care recordsen_ZA
dc.subjectClinical medicine -- Researchen_ZA
dc.subjectGeneXpert MTB/RIFen_ZA
dc.subjectTuberculosis -- Diagnosisen_ZA
dc.titleEffect of Xpert MTB/RIF on clinical outcomes in routine care settings : individual patient data meta-analysisen_ZA
dc.typeArticleen_ZA
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