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


BACKGROUND
clinicaltrials.gov NCT01363765.
Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; McGill University, Montreal, Canada.
Anete
A
Trajman
Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; Rio de Janeiro City Health Secretariat, Rio de Janeiro, Brazil.
Betina
B
Durovni
Rio de Janeiro City Health Secretariat, Rio de Janeiro, Brazil; Dr. Heitor Dourado Vieira Foundation of Tropical Medicine, Manaus, Brazil.
Valeria
V
Saraceni
Global Health Strategies, Rio de Janeiro, Brazil.
Alexandre
A
Menezes
Dr. Heitor Dourado Vieira Foundation of Tropical Medicine, Manaus, Brazil; Amazonas State University, Manaus, Brazil.
Marcelo
M
Cordeiro-Santos
Amsterdam Institute for Global Health and Development, Academic Medical Center, Amsterdam, Netherlands; KNCV Foundation, The Hague, Netherlands.
Frank
F
Cobelens
Amsterdam Institute for Global Health and Development, Academic Medical Center, Amsterdam, Netherlands; KNCV Foundation, The Hague, Netherlands.
Susan
S
Van den Hof
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004352:Drug Resistance, Microbial; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data*; D012293:Rifampin / Q000494:pharmacology; D013183:Sputum / Q000382:microbiology; D016896:Treatment Outcome; D014376:Tuberculosis / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality
D011933:Reagent Kits, Diagnostic; D012293:Rifampin