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

Detalhes bibliográficos
Autor(a) principal: Durovni, Betina
Data de Publicação: 2014
Outros Autores: Saraceni, Valeria, Hof, Susan van den, Anete, Trajman, Santos, Marcelo Cordeiro, Cavalcante, Solange, Menezes, Alexandre, Cobelens, Frank
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/10295
Resumo: Inclui correção 2015: Correction: Impact of Replacing Smear Microscopy with Xpert MTB/RIF for Diagnosing Tuberculosis in Brazil: A SteppedWedge Cluster-Randomized Trial.
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spelling Durovni, BetinaSaraceni, ValeriaHof, Susan van denAnete, TrajmanSantos, Marcelo CordeiroCavalcante, SolangeMenezes, AlexandreCobelens, Frank2015-05-12T17:41:46Z2015-05-12T17:41:46Z2014DUROVNI, Betina et al. Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial. Plos Medicine, v. 11, n. 12, p. 1-19, 2014.1549-1277https://www.arca.fiocruz.br/handle/icict/1029510.1371/journal.pmed.10017661549-1676Inclui correção 2015: Correction: Impact of Replacing Smear Microscopy with Xpert MTB/RIF for Diagnosing Tuberculosis in Brazil: A SteppedWedge Cluster-Randomized Trial.InCo-TB projectSecretaria Municipal de Saúde do Rio de Janeiro. Rio de Janeiro, RJ, Brasil / Universidade Federal do Rio de Janeiro. Rio de Janeiro, RJ, Brasil.Secretaria Municipal de Saúde do Rio de Janeiro. Rio de Janeiro, RJ, Brasil / Fundação de Medicina Tropical Doutor Heitor Vieira Dourado. Manaus, AM, Brasil.KNCV Tuberculosis Foundation. The Hague, Netherlands / Academic Medical Center and Amsterdam Institute for Global Health and Development. Department of Global Health. Amsterdam, Netherlands.Universidade Federal do Rio de Janeiro. Rio de Janeiro, RJ, Brasil / McGill University. Montreal Chest Institute. Montreal, Canada.Fundação de Medicina Tropical Doutor Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Secretaria Municipal de Saúde do Rio de Janeiro. Rio de Janeiro, RJ, Brasil.Global Health Strategies. Rio de Janeiro, RJ, Brasil.KNCV Tuberculosis Foundation. The Hague, Netherlands / Academic Medical Center and Amsterdam Institute for Global Health and Development. Department of Global Health. Amsterdam, Netherlands.Background: Abundant 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 Findings: We 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 twosputum- 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 =26%, 37%), and we observed no change in the notification rate for those without a test result (23%, 95% CI =237%, 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. Conclusions: Replacing 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.engPublic Library of ScienceImpact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleMycobacterium tuberculosisPolymerase Chain ReactionBrazilRifampinXpert MTB/RIFMycobacterium tuberculosisReação em Cadeia da PolimeraseBrasilRifampinainfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82352https://www.arca.fiocruz.br/bitstream/icict/10295/1/license.txtafbdf7d7a9bcf771a1cc7edf5f618413MD51ORIGINALImpact of replacing smear microscopy with Xpert MTB RIF for diagnosing tuberculosis in Brazil a stepped wedge cluster randomized trial.pdfImpact of replacing smear microscopy with Xpert MTB 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dc.title.pt_BR.fl_str_mv Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial
title Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial
spellingShingle Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial
Durovni, Betina
Mycobacterium tuberculosis
Polymerase Chain Reaction
Brazil
Rifampin
Xpert MTB/RIF
Mycobacterium tuberculosis
Reação em Cadeia da Polimerase
Brasil
Rifampina
title_short Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial
title_full Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial
title_fullStr Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial
title_full_unstemmed Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial
title_sort Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial
author Durovni, Betina
author_facet Durovni, Betina
Saraceni, Valeria
Hof, Susan van den
Anete, Trajman
Santos, Marcelo Cordeiro
Cavalcante, Solange
Menezes, Alexandre
Cobelens, Frank
author_role author
author2 Saraceni, Valeria
Hof, Susan van den
Anete, Trajman
Santos, Marcelo Cordeiro
Cavalcante, Solange
Menezes, Alexandre
Cobelens, Frank
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Durovni, Betina
Saraceni, Valeria
Hof, Susan van den
Anete, Trajman
Santos, Marcelo Cordeiro
Cavalcante, Solange
Menezes, Alexandre
Cobelens, Frank
dc.subject.en.pt_BR.fl_str_mv Mycobacterium tuberculosis
Polymerase Chain Reaction
Brazil
Rifampin
Xpert MTB/RIF
topic Mycobacterium tuberculosis
Polymerase Chain Reaction
Brazil
Rifampin
Xpert MTB/RIF
Mycobacterium tuberculosis
Reação em Cadeia da Polimerase
Brasil
Rifampina
dc.subject.decs.pt_BR.fl_str_mv Mycobacterium tuberculosis
Reação em Cadeia da Polimerase
Brasil
Rifampina
description Inclui correção 2015: Correction: Impact of Replacing Smear Microscopy with Xpert MTB/RIF for Diagnosing Tuberculosis in Brazil: A SteppedWedge Cluster-Randomized Trial.
publishDate 2014
dc.date.issued.fl_str_mv 2014
dc.date.accessioned.fl_str_mv 2015-05-12T17:41:46Z
dc.date.available.fl_str_mv 2015-05-12T17:41:46Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.citation.fl_str_mv DUROVNI, Betina et al. Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial. Plos Medicine, v. 11, n. 12, p. 1-19, 2014.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/10295
dc.identifier.issn.none.fl_str_mv 1549-1277
dc.identifier.doi.none.fl_str_mv 10.1371/journal.pmed.1001766
dc.identifier.eissn.none.fl_str_mv 1549-1676
identifier_str_mv DUROVNI, Betina et al. Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial. Plos Medicine, v. 11, n. 12, p. 1-19, 2014.
1549-1277
10.1371/journal.pmed.1001766
1549-1676
url https://www.arca.fiocruz.br/handle/icict/10295
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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