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 Luca
dc.contributor.authorKhaki, Ali Raza
dc.contributor.authorTheron, Grant
dc.contributor.authorMcCarthy, Kerrigan
dc.contributor.authorCox, Helen
dc.contributor.authorMupfumi, Lucy
dc.contributor.authorTrajman, Anete
dc.contributor.authorZijenah, Lynn Sodai
dc.contributor.authorMason, Peter
dc.contributor.authorBandason, Tsitsi
dc.contributor.authorDurovni, Betina
dc.contributor.authorBara, Wilbert
dc.contributor.authorHoelscher, Michael
dc.contributor.authorClowes, Petra
dc.contributor.authorMangu, Chacha
dc.contributor.authorChanda, Duncan
dc.contributor.authorPym, Alexander
dc.contributor.authorMwaba, Peter
dc.contributor.authorCobelens, Frank
dc.contributor.authorNicol, Mark P
dc.contributor.authorDheda, Keertan
dc.contributor.authorChurchyard, Gavin
dc.contributor.authorFielding, Katherine
dc.contributor.authorMetcalfe, John Z
dc.date.accessioned2024-12-11T18:46:55Z
dc.date.available2024-12-11T18:46:55Z
dc.date.issued2019
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. Funding US National Institutes of Health.
dc.identifier.citationDi Tanna GL, Khaki AR, Theron G, McCarthy K, Cox H, Mupfumi L, Trajman A, Zijenah LS, Mason P, Bandason T, Durovni B, Bara W, Hoelscher M, Clowes P, Mangu C, Chanda D, Pym A, Mwaba P, Cobelens F, Nicol MP, Dheda K, Churchyard G, Fielding K, Metcalfe JZ. Effect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis. Lancet Glob Health. 2019 Feb;7(2):e191-e199. doi: 10.1016/S2214-109X(18)30458-3. Erratum in: Lancet Glob Health. 2019 Apr;7(4):e419. doi: 10.1016/S2214-109X(19)30046-4.
dc.identifier.otherDOI: 10.1016/S2214-109X(18)30458-3
dc.identifier.urihttps://dspace.inc.saude.gov.br/handle/123456789/702
dc.language.isoen
dc.publisherThe Lancet Global Health
dc.subjectAdulten
dc.subjectAntitubercular Agents / therapeutic useen
dc.subjectBrazil / epidemiologyen
dc.subjectCause of Deathen
dc.subjectFemaleen
dc.subjectHIV Infections / epidemiologyen
dc.subjectHumansen
dc.subjectMaleen
dc.subjectMiddle Ageden
dc.subjectMortalityen
dc.subjectMycobacterium tuberculosis / genetics*en
dc.subjectMycobacterium tuberculosis / isolation & purificationen
dc.subjectNucleic Acid Amplification Techniques*en
dc.subjectOdds Ratioen
dc.subjectOutcome Assessment, Health Careen
dc.subjectProportional Hazards Modelsen
dc.subjectSouth Africa / epidemiologyen
dc.subjectSputum / microbiology*en
dc.subjectTanzania / epidemiologyen
dc.subjectTime-to-Treatment / statistics & numerical dataen
dc.subjectTuberculosis, Pulmonary / diagnosis*en
dc.subjectTuberculosis, Pulmonary / drug therapyen
dc.subjectTuberculosis, Pulmonary / epidemiologyen
dc.subjectTuberculosis, Pulmonary / mortalityen
dc.subjectZambia / epidemiologyen
dc.subjectZimbabwe / epidemiologyen
dc.titleEffect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis
dc.typeArticle
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