Evidence map›Paper›PMID 25490549›Full record

Trial reportPLoS medicine2014

Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial.

Betina Durovni, Valeria Saraceni, Susan van den Hof, Anete Trajman, Marcelo Cordeiro-Santos, Solange Cavalcante, Alexandre Menezes, Frank Cobelens

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled 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. An erratum has been issued. It is linked to trial NCT01363765 (Pilot Roll Out of the Xpert MTB/Rif for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil), which is not on this map. Cited by 90 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 10 pooled it
9.0field-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.

NCT01363765 phase4completednot on this map

Pilot Roll Out of the Xpert MTB/Rif for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil: a Stepped Wedge Trial

TypeinterventionalSponsorAtaulpho de Paiva FoundationRan2012 to 2012Enrolled34,758ConditionsTuberculosisArmsXpert MTB/Rif, Smear microscopy
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 10 syntheses or guidelines pooled it, 144 citations in OpenAlex.

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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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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 3 countries.

Betina DurovniRio de Janeiro Municipal Health Secretariat, Rio de Janeiro, Brazil; Programa de Pós-graduação em Clínica Médica, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
Valeria SaraceniRio de Janeiro Municipal Health Secretariat, Rio de Janeiro, Brazil; Programa de Pós-graduação em Doenças Infecciosas, Tropical Medicine Foundation Dr. Heitor Vieira Dourado, Manaus, Brazil.
Susan van den HofKNCV Tuberculosis Foundation, The Hague, The Netherlands; Department of Global Health, Academic Medical Center and Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.
Anete TrajmanPrograma de Pós-graduação em Clínica Médica, Rio de Janeiro Federal University, Rio de Janeiro, Brazil; Montreal Chest Institute, McGill University, Montreal, Canada.
Marcelo Cordeiro-SantosPrograma de Pós-graduação em Doenças Infecciosas, Tropical Medicine Foundation Dr. Heitor Vieira Dourado, Manaus, Brazil; Amazonas State University, Manaus, Brazil.
Solange CavalcanteRio de Janeiro Municipal Health Secretariat, Rio de Janeiro, Brazil; Oswaldo Cruz Foundation, Instituto de Pesquisa Evandro Chagas, Rio de Janeiro, Brazil.
Alexandre MenezesGlobal Health Strategies, Rio de Janeiro, Brazil.
Frank CobelensKNCV Tuberculosis Foundation, The Hague, The Netherlands; Department of Global Health, Academic Medical Center and Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.
Universidade Federal do Rio de Janeiro · BRAcademic Medical Center · NLAmsterdam Institute for Global Health and Development · NLFundação de Medicina Tropical · BRFundação Oswaldo Cruz · BRUniversidade do Estado do Amazonas · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAbundant evidence on Xpert MTB/RIF accuracy for diagnosing tuberculosis (TB) and rifampicin resistance has been produced, yet there are few data on the population benefit of its programmatic use. We assessed whether the implementation of Xpert MTB/RIF in routine conditions would (1) increase the notification rate of laboratory-confirmed pulmonary TB to the national notification system and (2) reduce the time to TB treatment initiation (primary endpoints). METHODS AND

findingsWe conducted a stepped-wedge cluster-randomized trial from 4 February to 4 October 2012 in 14 primary care laboratories in two Brazilian cities. Diagnostic specimens were included for 11,705 baseline (smear microscopy) and 12,522 intervention (Xpert MTB/RIF) patients presumed to have TB. Single-sputum-sample Xpert MTB/RIF replaced two-sputum-sample smear microscopy for routine diagnosis of pulmonary TB. In total, 1,137 (9.7%) tests in the baseline arm and 1,777 (14.2%) in the intervention arm were positive (p<0.001), resulting in an increased bacteriologically confirmed notification rate of 59% (95% CI = 31%, 88%). However, the overall notification rate did not increase (15%, 95% CI =  -6%, 37%), and we observed no change in the notification rate for those without a test result (-3%, 95% CI = -37%, 30%). Median time to treatment decreased from 11.4 d (interquartile range [IQR] = 8.5-14.5) to 8.1 d (IQR = 5.4-9.3) (p = 0.04), although not among confirmed cases (median 7.5 [IQR = 4.9-10.0] versus 7.3 [IQR = 3.4-9.0], p = 0.51). Prevalence of rifampicin resistance detected by Xpert was 3.3% (95% CI = 2.4%, 4.3%) among new patients and 7.4% (95% CI = 4.3%, 11.7%) among retreatment patients, with a 98% (95% CI = 87%, 99%) positive predictive value compared to phenotypic drug susceptibility testing. Missing data in the information systems may have biased our primary endpoints. However, sensitivity analyses assessing the effects of missing data did not affect our results.

conclusionsReplacing smear microscopy with Xpert MTB/RIF in Brazil increased confirmation of pulmonary TB. An additional benefit was the accurate detection of rifampicin resistance. However, no increase on overall notification rates was observed, possibly because of high rates of empirical TB treatment.

trial registrationClinicalTrials.gov NCT01363765. Please see later in the article for the Editors' Summary.

Indexed as

AdolescentAdultAntibiotics, AntitubercularBrazilFemaleHumansMaleMiddle AgedMolecular Diagnostic TechniquesPolymerase Chain ReactionRifampinSensitivity and SpecificityTuberculosisTuberculosis, Multidrug-ResistantYoung AdultAntibiotics, AntitubercularRifampin

Identifiers

PMID25490549
PMCPMC4260794
OpenAlexW2083276190

What OpenQuestion holds

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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.