Evidence map›Paper›PMID 26187490›Full record

Trial reportThe Lancet. Global health2015

Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF.

Gavin J Churchyard, Wendy S Stevens, Lerole D Mametja, Kerrigan M McCarthy, Violet Chihota, Mark P Nicol, Linda K Erasmus, Norbert O Ndjeka, Lindiwe Mvusi, Anna Vassall and 5 more

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Publisher
In one paragraph

Trial report in The Lancet. Global health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 139 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
139citing papers in PubMed, 13 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

139 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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  9. Treatment outcomes, diagnostic and therapeutic impact: Xpert vs. smear. A systematic review and meta-analysis.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2019
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79 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Gavin J ChurchyardAurum Institute, Johannesburg, South Africa; London School of Hygiene & Tropical Medicine, London, United Kingdom; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: gchurchyard@auruminstitute.org.
Wendy S StevensNational Health Laboratory Service, Johannesburg, South Africa; Department of Molecular Medicine and Haematology, University of the Witwatersrand, Johannesburg, South Africa.
Lerole D MametjaTB Cluster, National Department of Health, South Africa.
Kerrigan M McCarthyAurum Institute, Johannesburg, South Africa.
Violet ChihotaAurum Institute, Johannesburg, South Africa.
Mark P NicolNational Health Laboratory Service, Johannesburg, South Africa; Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa.
Linda K ErasmusNational Health Laboratory Service, Johannesburg, South Africa; Division of Public Health Surveillance and Response, National Institute for Communicable Diseases, Johannesburg, South Africa.
Norbert O NdjekaTB Cluster, National Department of Health, South Africa.
Lindiwe MvusiTB Cluster, National Department of Health, South Africa.
Anna VassallLondon School of Hygiene & Tropical Medicine, London, United Kingdom.
Edina SinanovicHealth Economics Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Helen S CoxDivision of Medical Microbiology, University of Cape Town, Cape Town, South Africa.
Christopher DyeWorld Health Organization, Geneva, Switzerland.
Alison D GrantLondon School of Hygiene & Tropical Medicine, London, United Kingdom; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.
Katherine L FieldingLondon School of Hygiene & Tropical Medicine, London, United Kingdom.

Funding

Medical Research Council MR/K012126/1World Health Organization 001
6 · The paper itself

Abstract

backgroundIn South Africa, sputum smear microscopy has been replaced with Xpert MTB/RIF as the initial diagnostic test for tuberculosis. In a pragmatic parallel cluster-randomised trial, we evaluated the effect on patient and programme outcomes.

methodsWe randomly allocated 20 laboratories (clusters) in medium-burden districts of South Africa to either an Xpert (immediate Xpert) or microscopy (Xpert deferred) group (1:1), stratified by province. At two primary care clinics per laboratory, a systematic sample of adults giving sputum for tuberculosis investigation was assessed for eligibility. The primary outcome was mortality at 6 months from enrolment. Masking of participants' group allocation was not possible because of the pragmatic trial design. The trial is registered with the ISRCTN registry (ISRCTN68905568) and the South African Clinical Trial Register (DOH-27-1011-3849).

findingsBetween June and November, 2012, 4972 people were screened, and 4656 (93·6%) enrolled (median age 36 years; 2891 [62%] female; 2212 [62%] reported being HIV-positive). There was no difference between the Xpert and microscopy groups with respect to mortality at 6 months (91/2324 [3·9%] vs 116/2332 [5·0%], respectively; adjusted risk ratio [aRR] 1·10, 95% CI 0·75-1·62]).

interpretationXpert did not reduce mortality at 6 months compared with sputum microscopy. Improving outcomes in drug-sensitive tuberculosis programmes might require not only better diagnostic tests but also better linkage to care.

fundingBill & Melinda Gates Foundation.

Indexed as

AdultAnalysis of VarianceAntitubercular AgentsComorbidityDrug Resistance, BacterialEndpoint DeterminationFemaleHIV InfectionsHumansMaleMiddle AgedMolecular Diagnostic TechniquesMortalityOutcome and Process Assessment, Health CareRifampinSouth AfricaAntitubercular AgentsRifampin

Identifiers

PMID26187490

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.