Evidence map›Paper›PMID 25915745›Full record

Trial reportPloS one2015

Impact on Patients' Treatment Outcomes of XpertMTB/RIF Implementation for the Diagnosis of Tuberculosis: Follow-Up of a Stepped-Wedge Randomized Clinical Trial.

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

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

Trial report in PloS one, 2015. 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 33 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 8 pooled it
4.5field-weighted citation impact, top 5% 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

33 citing papers in PubMed, 8 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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  6. 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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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 3 countries.

Anete TrajmanFederal University of Rio de Janeiro, Rio de Janeiro, Brazil; McGill University, Montreal, Canada.
Betina DurovniFederal University of Rio de Janeiro, Rio de Janeiro, Brazil; Rio de Janeiro City Health Secretariat, Rio de Janeiro, Brazil.
Valeria SaraceniRio de Janeiro City Health Secretariat, Rio de Janeiro, Brazil; Dr. Heitor Dourado Vieira Foundation of Tropical Medicine, Manaus, Brazil.
Alexandre MenezesGlobal Health Strategies, Rio de Janeiro, Brazil.
Marcelo Cordeiro-SantosDr. Heitor Dourado Vieira Foundation of Tropical Medicine, Manaus, Brazil; Amazonas State University, Manaus, Brazil.
Frank CobelensAmsterdam Institute for Global Health and Development, Academic Medical Center, Amsterdam, Netherlands; KNCV Foundation, The Hague, Netherlands.
Susan Van den HofAmsterdam Institute for Global Health and Development, Academic Medical Center, Amsterdam, Netherlands; KNCV Foundation, The Hague, Netherlands.
Amsterdam Institute for Global Health and Development · NLFundação de Medicina Tropical · BRMcGill University · CAUniversidade do Estado do Amazonas · BRUniversidade Federal do Rio de Janeiro · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe impact on treatment outcomes of XpertMTB/RIF, a molecular-based test that provides rapid diagnosis of tuberculosis (TB) and rifampicin resistance with high accuracy, has not been reported despite its adoption in a few countries. We here report treatment outcomes in a step-wedged cluster randomized trial for patients diagnosed with XpertMTB/RIF compared to patients diagnosed with sputum smear examination in public health facilities in Brazil.

methodsTreatment outcome data were added to the trial database of patients diagnosed from 4 February to 4 October 2012, and crosschecked with data from the national mortality and the drug-resistant TB registers. Treatment outcomes in the intervention (n=2232) and baseline (n=1856) arms were compared using a multilevel regression model.

resultsUnfavourable outcomes were frequent in both arms, mainly due to loss to follow-up (16%). Overall unfavourable outcomes were not reduced in the intervention arm (29.6% versus 31.7%, OR=0.93; 95%CI=0.79-1.08). However, the overall TB-attributed death rate was lower in the intervention arm (2.3% vs. 3.8%). Adjusted for HIV status, age group and city, the intervention resulted in a 35% decrease in TB-attributed deaths (OR=0.65, 95%CI=0.44-0.97).

conclusionsThe proportion of patients successfully treated did not increase with Xpert MTB/RIF implementation, with high loss to follow-up rates in both arms. We did observe a 35% reduction in TB-related mortality, which we hypothesize may be explained by less advanced disease among the smear-negative patients diagnosed by Xpert. In conclusion, XpertMTB/RIF introduction did not improve TB treatment outcomes in Brazil.

trial registrationclinicaltrials.gov NCT01363765.

Indexed as

AdolescentAdultAgedChildChild, PreschoolDrug Resistance, MicrobialFemaleFollow-Up StudiesHumansInfantMaleMiddle AgedMycobacterium tuberculosisReagent Kits, DiagnosticRifampinSputumReagent Kits, DiagnosticRifampin

Identifiers

PMID25915745
PMCPMC4411054
OpenAlexW2032989933

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.