Evidence map›Paper›PMID 25423041›Full record

Trial reportPLoS medicine2014

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.

Helen S Cox, Slindile Mbhele, Neisha Mohess, Andrew Whitelaw, Odelia Muller, Widaad Zemanay, Francesca Little, Virginia Azevedo, John Simpson, Catharina C Boehme and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PLoS medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04433195 (Xpert MTB/RIF Test as the Initial Diagnostic Test in the Diagnosis of Pulmonary Tuberculosis), which is not on this map. Cited by 89 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 13 pooled it
10.4field-weighted citation impact, top 1% of its field
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.

NCT04433195 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Xpert MTB/RIF Test as the Initial Diagnostic Test in the Diagnosis of Pulmonary Tuberculosis: a Pragmatic Trial

TypeinterventionalSponsorTaipei Medical University WanFang HospitalRan2020 to 2022Enrolled6,900ConditionsPulmonary Tuberculosis Confirmation by CultureArmsXpert MTB/RIF test
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 13 syntheses or guidelines pooled it, 152 citations in OpenAlex.

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  10. 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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29 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 2 countries.

Helen S CoxDivision of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa; Médecins Sans Frontières, Khayelitsha, South Africa.
Slindile MbheleDivision of Medical Microbiology, University of Cape Town, Cape Town, South Africa.
Neisha MohessDivision of Medical Microbiology, University of Cape Town, Cape Town, South Africa.
Andrew WhitelawDivision of Medical Microbiology, University of Cape Town, Cape Town, South Africa; National Health Laboratory Service, Johannesburg, South Africa.
Odelia MullerMédecins Sans Frontières, Khayelitsha, South Africa.
Widaad ZemanayDivision of Medical Microbiology, University of Cape Town, Cape Town, South Africa.
Francesca LittleDepartment of Statistical Science, University of Cape Town, Cape Town, South Africa.
Virginia AzevedoKhayelitsha Health, City of Cape Town, Cape Town, South Africa.
John SimpsonNational Health Laboratory Service, Johannesburg, South Africa.
Catharina C BoehmeFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Mark P NicolDivision of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
University of Cape Town · ZACity of Cape Town · ZAFoundation for Innovative New Diagnostics · CHMédecins Sans Frontières · ZANational Health Laboratory Service · ZA

Funding

Wellcome TrustWellcome Trust 085215
6 · The paper itself

Abstract

backgroundXpert 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

findingsA 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.

conclusionsThese 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.

trial registrationPan African Clinical Trials Registry PACTR201010000255244. Please see later in the article for the Editors' Summary.

Indexed as

Drug Resistance, BacterialTime-to-TreatmentAdolescentAdultAgedAmbulatory Care FacilitiesAntibiotics, AntitubercularFemaleHIV InfectionsHumansMaleMiddle AgedMycobacterium tuberculosisPrevalencePrimary Health CareProspective StudiesAntibiotics, AntitubercularRifampin

Identifiers

PMID25423041
PMCPMC4244039
OpenAlexW2044132732

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.