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Randomized Controlled Trial
. 2015 Apr 27;10(4):e0123252.
doi: 10.1371/journal.pone.0123252. eCollection 2015.

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  1 , Betina Durovni  2 , Valeria Saraceni  3 , Alexandre Menezes  4 , Marcelo Cordeiro-Santos  5 , Frank Cobelens  6 , Susan Van den Hof  6
Affiliations
Randomized Controlled Trial

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 et al. PLoS One. .

Erratum in

Abstract

Introduction: The 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.

Methods: Treatment 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.

Results: Unfavourable 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).

Conclusions: The 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 registration: clinicaltrials.gov NCT01363765.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flowchart of patients included in the present analyses.
Flowchart showing study inclusion in baseline (smear examination) and intervention (Xpert MTB/RIF) arm.
See this image and copyright information in PMC

References

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    1. Durovni B. XpertMTB/Rif for diagnosing pulmonary tuberculosis: a stepped-wedge cluster-randomized trial. PLoS Med (in press). 2014; - PMC - PubMed

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