메뉴 건너뛰기




Volumn 11, Issue 12, 2014, Pages

Impact of Replacing Smear Microscopy with Xpert MTB/RIF for Diagnosing Tuberculosis in Brazil: A Stepped-Wedge Cluster-Randomized Trial

Author keywords

[No Author keywords available]

Indexed keywords

RIFAMPICIN; TUBERCULOSTATIC AGENT;

EID: 84920935668     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001766     Document Type: Article
Times cited : (109)

References (46)
  • 1
    • 84861029136 scopus 로고    scopus 로고
    • Scaling up interventions to achieve global tuberculosis control: progress and new developments
    • Raviglione M, Marais B, Floyd K, Lönnroth K, Getahun H, et al. (2012) Scaling up interventions to achieve global tuberculosis control: progress and new developments. Lancet 379: 1902–1913 doi:10.1016/S0140-6736(12)60727-2
    • (2012) Lancet , vol.379 , pp. 1902-1913
    • Raviglione, M.1    Marais, B.2    Floyd, K.3    Lönnroth, K.4    Getahun, H.5
  • 2
    • 77956497725 scopus 로고    scopus 로고
    • Rapid molecular detection of tuberculosis and rifampin resistance
    • Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, et al. (2010) Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 363: 1005–1015 doi:10.1056/NEJMoa0907847
    • (2010) N Engl J Med , vol.363 , pp. 1005-1015
    • Boehme, C.C.1    Nabeta, P.2    Hillemann, D.3    Nicol, M.P.4    Shenai, S.5
  • 3
    • 79955571240 scopus 로고    scopus 로고
    • Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study
    • Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, et al. (2011) Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet 377: 1495–1505 doi:10.1016/S0140-6736(11)60438-8
    • (2011) Lancet , vol.377 , pp. 1495-1505
    • Boehme, C.C.1    Nicol, M.P.2    Nabeta, P.3    Michael, J.S.4    Gotuzzo, E.5
  • 4
    • 84895071180 scopus 로고    scopus 로고
    • Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial
    • Theron G, Zijenah L, Chanda D, Clowes P, Rachow A, et al. (2014) Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet 383: 424–435 doi:10.1016/S0140-6736(13)62073-5
    • (2014) Lancet , vol.383 , pp. 424-435
    • Theron, G.1    Zijenah, L.2    Chanda, D.3    Clowes, P.4    Rachow, A.5
  • 5
    • 84874887247 scopus 로고    scopus 로고
    • Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults
    • Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, et al. (2014) Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 1: CD009593 doi:10.1002/14651858.CD009593.pub3
    • (2014) Cochrane Database Syst Rev , vol.1 , pp. CD009593
    • Steingart, K.R.1    Schiller, I.2    Horne, D.J.3    Pai, M.4    Boehme, C.C.5
  • 6
    • 84884639475 scopus 로고    scopus 로고
    • Cost-effectiveness of Xpert® MTB/RIF for diagnosing pulmonary tuberculosis in the United States
    • Choi HW, Miele K, Dowdy D, Shah M, (2013) Cost-effectiveness of Xpert® MTB/RIF for diagnosing pulmonary tuberculosis in the United States. Int J Tuberc Lung Dis 17: 1328–1335 doi:10.5588/ijtld.13.0095
    • (2013) Int J Tuberc Lung Dis , vol.17 , pp. 1328-1335
    • Choi, H.W.1    Miele, K.2    Dowdy, D.3    Shah, M.4
  • 7
    • 84870266092 scopus 로고    scopus 로고
    • Population health impact and cost-effectiveness of tuberculosis diagnosis with Xpert MTB/RIF: a dynamic simulation and economic evaluation
    • Menzies NA, Cohen T, Lin H-H, Murray M, Salomon JA, (2012) Population health impact and cost-effectiveness of tuberculosis diagnosis with Xpert MTB/RIF: a dynamic simulation and economic evaluation. PLoS Med 9: e1001347 doi:10.1371/journal.pmed.1001347
    • (2012) PLoS Med , vol.9 , pp. e1001347
    • Menzies, N.A.1    Cohen, T.2    Lin, H.-H.3    Murray, M.4    Salomon, J.A.5
  • 8
    • 82455205785 scopus 로고    scopus 로고
    • Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a cost-effectiveness analysis
    • Vassall A, van Kampen S, Sohn H, Michael JS, John KR, et al. (2011) Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a cost-effectiveness analysis. PLoS Med 8: e1001120 doi:10.1371/journal.pmed.1001120
    • (2011) PLoS Med , vol.8 , pp. e1001120
    • Vassall, A.1    van Kampen, S.2    Sohn, H.3    Michael, J.S.4    John, K.R.5
  • 9
    • 84920952916 scopus 로고    scopus 로고
    • World Health Organization (2012) Tuberculosis diagnostics Xpert MTB/RIF test. WHO endorsement and recommendations. Available: http://www.who.int/tb/features_archive/factsheet_xpert_may2011update.pdf. Accessed 9 November 2013.
  • 10
    • 84920952915 scopus 로고    scopus 로고
    • World Health Organization (2011) Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children. Available: http://www.stoptb.org/wg/gli/assets/documents/WHO%20Policy%20Statement%20on%20Xpert%20MTB-RIF%202013%20pre%20publication%2022102013.pdf. Accessed 13 November 2014.
  • 11
    • 77956537137 scopus 로고    scopus 로고
    • Tuberculosis diagnosis—time for a game change
    • Small PM, Pai M, (2010) Tuberculosis diagnosis—time for a game change. N Engl J Med 363: 1070–1071.
    • (2010) N Engl J Med , vol.363 , pp. 1070-1071
    • Small, P.M.1    Pai, M.2
  • 12
    • 44349190420 scopus 로고    scopus 로고
    • Grading quality of evidence and strength of recommendations for diagnostic tests and strategies
    • Schunemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, et al. (2008) Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 336: 1106–1110 doi:10.1136/bmj.39500.677199.AE
    • (2008) BMJ , vol.336 , pp. 1106-1110
    • Schunemann, H.J.1    Oxman, A.D.2    Brozek, J.3    Glasziou, P.4    Jaeschke, R.5
  • 13
    • 84860372578 scopus 로고    scopus 로고
    • Which new diagnostics for tuberculosis, and when?
    • Cobelens F, van den Hof S, Pai M, Squire SB, Ramsay A, et al. (2012) Which new diagnostics for tuberculosis, and when? J Infect Dis 205 (Suppl 2): S191–S198 doi:10.1093/infdis/jis188
    • (2012) J Infect Dis , vol.205 , pp. S191-S198
    • Cobelens, F.1    van den Hof, S.2    Pai, M.3    Squire, S.B.4    Ramsay, A.5
  • 14
    • 84878806288 scopus 로고    scopus 로고
    • Time to treatment and patient outcomes among TB suspects screened by a single point-of-care Xpert MTB/RIF at a primary care clinic in Johannesburg, South Africa
    • Hanrahan CF, Selibas K, Deery CB, Dansey H, Clouse K, et al. (2013) Time to treatment and patient outcomes among TB suspects screened by a single point-of-care Xpert MTB/RIF at a primary care clinic in Johannesburg, South Africa. PLoS ONE 8: e65421 doi:10.1371/journal.pone.0065421
    • (2013) PLoS ONE , vol.8 , pp. e65421
    • Hanrahan, C.F.1    Selibas, K.2    Deery, C.B.3    Dansey, H.4    Clouse, K.5
  • 15
    • 84876434003 scopus 로고    scopus 로고
    • Impact of Xpert MTB/RIF testing on tuberculosis management and outcomes in hospitalized patients in Uganda
    • Yoon C, Cattamanchi A, Davis JL, Worodria W, den Boon S, et al. (2012) Impact of Xpert MTB/RIF testing on tuberculosis management and outcomes in hospitalized patients in Uganda. PLoS ONE 7: e48599 doi:10.1371/journal.pone.0048599
    • (2012) PLoS ONE , vol.7 , pp. e48599
    • Yoon, C.1    Cattamanchi, A.2    Davis, J.L.3    Worodria, W.4    den Boon, S.5
  • 16
    • 84920952914 scopus 로고    scopus 로고
    • World Health Organization (2014) TB diagnostics and laboratory strengthening: WHO monitoring of Xpert MTB/RIF roll-out. Available: http://who.int/tb/laboratory/mtbrifrollout/en/. Accessed 31 October 2014.
  • 17
    • 57349108691 scopus 로고    scopus 로고
    • Improving the reporting of pragmatic trials: an extension of the CONSORT statement
    • Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, et al. (2008) Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 337: a2390.
    • (2008) BMJ , vol.337 , pp. a2390
    • Zwarenstein, M.1    Treweek, S.2    Gagnier, J.J.3    Altman, D.G.4    Tunis, S.5
  • 18
    • 84920952913 scopus 로고    scopus 로고
    • World Health Organization (2014) Global tuberculosis report 2014. Available: http://apps.who.int/iris/bitstream/10665/137094/1/9789241564809_eng.pdf?ua=1. Accessed 13 November 2014.
  • 19
    • 84920952912 scopus 로고    scopus 로고
    • Brasil Ministério da Saúde Secretaria de Vigilância Sanitária Programa Nacional de Controle da Tuberculose (2011) Manual de recomendações para o controle da tuberculose no Brasil. Available: http://www.cve.saude.sp.gov.br/htm/TB/mat_tec/manuais/MS11_Manual_Recom.pdf. Accessed 13 November 2014.
  • 20
    • 84920952911 scopus 로고    scopus 로고
    • Brasil Ministério da Saúde Secretaria de Vigilância em Saúde Programa Nacional de Controle da Tuberculose (2013) Programa Nacional de Controle da Tuberculose. Available: https://docs.google.com/file/d/0B0CE2wqdEaR-VG1fa0JJMi1qa0U/edit. Accessed 31 March 2014.
  • 21
    • 84920952910 scopus 로고    scopus 로고
    • Portal da Saúde (2013). Sistema de Informação de Agravos de Notificação—SINAN. O que é o SINAN. Available: http://dtr2004.saude.gov.br/sinanweb/. Accessed 4 July 2013.
  • 22
    • 84920952909 scopus 로고    scopus 로고
    • Portal da Saúde (2013) DATASUS: Informações de Saúde—demográficas e socioeconômicas [database]. Available: http://www2.datasus.gov.br/DATASUS/index.php?area=0206&VObj=http://tabnet.datasus.gov.br/cgi/deftohtm.exe?ibge/cnv/pop. Accessed 8 July 2013.
  • 23
    • 84920952908 scopus 로고    scopus 로고
    • Cepheid (n.d.) The new GeneXpert® system. Available: http://www.google.com.br/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CB8QFjAA&url=http%3A%2F%2Fwww.cepheid.com%2Fus%2Fcomponent%2Fphocadownload%2Fcategory%2F1-about-us%3Fdownload%3D41%3Agx-brochure&ei=1S9lVLGKFYyagwSdkIQY&usg=AFQjCNHOvPFFlDOkUPcxH9BU2dXGI6ypxQ&sig2=BVKcXMgB2MT1g0G0m40zaQ&bvm=bv.79189006,d.eXY. Accessed 13 November 2014.
  • 24
    • 84920952907 scopus 로고    scopus 로고
    • Cepheid (2009) Xpert®MTB/RIF: two-hour detection of MTB and resistance to rifampicin. Available: http://tbevidence.org/documents/rescentre/sop/XpertMTB_Broch_R9_EU.pdf. Accessed 31 March 2014.
  • 25
    • 33751175451 scopus 로고    scopus 로고
    • The stepped wedge trial design: a systematic review
    • Brown CA, Lilford RJ, (2006) The stepped wedge trial design: a systematic review. BMC Med Res Methodol 6: 54 doi:10.1186/1471-2288-6-54
    • (2006) BMC Med Res Methodol , vol.6 , pp. 54
    • Brown, C.A.1    Lilford, R.J.2
  • 26
    • 70349724205 scopus 로고    scopus 로고
    • Cluster randomized trials
    • Hayes RJ, Moulton LH (2009) Cluster randomized trials. Boca Raton (Florida): Chapman & Hall/CRC.
    • (2009)
    • Hayes, R.J.1    Moulton, L.H.2
  • 27
    • 34249295234 scopus 로고    scopus 로고
    • Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention
    • Moulton LH, Golub JE, Durovni B, Cavalcante SC, Pacheco AG, et al. (2007) Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention. Clin Trials 4: 190–199 doi:10.1177/1740774507076937
    • (2007) Clin Trials , vol.4 , pp. 190-199
    • Moulton, L.H.1    Golub, J.E.2    Durovni, B.3    Cavalcante, S.C.4    Pacheco, A.G.5
  • 28
    • 0034166264 scopus 로고    scopus 로고
    • [Reclink: an application for database linkage implementing the probabilistic record linkage method.]
    • Camargo KR, JrCoeli CM, (2000) [Reclink: an application for database linkage implementing the probabilistic record linkage method.]. Cad Saude Publica 16: 439–447.
    • (2000) Cad Saude Publica , vol.16 , pp. 439-447
    • Camargo, K.R.1    Coeli, C.M.2
  • 29
    • 84920952906 scopus 로고    scopus 로고
    • Sistema de Informação de Tratamentos Especiais de Tuberculose (2014) SITETB. Available: http://www.sitetb.org. Accessed 13 November 2014
    • Sistema de Informação de Tratamentos Especiais de Tuberculose (2014) SITETB. Available: http://www.sitetb.org. Accessed 13 November 2014.
  • 30
    • 84920952905 scopus 로고    scopus 로고
    • Instituto Brasileiro de Geografia e Estatística (2013) Estimativas da população: metodologia adotada nas estimativas populacionais municipais. Available: http://www.ibge.gov.br/home/estatistica/populacao/estimativa2005/estimativa_pop.shtm. Accessed 5 December 2013.
  • 31
    • 33845574387 scopus 로고    scopus 로고
    • Design and analysis of stepped wedge cluster randomized trials
    • Hussey MA, Hughes JP, (2007) Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials 28: 182–191 doi:10.1016/j.cct.2006.05.007
    • (2007) Contemp Clin Trials , vol.28 , pp. 182-191
    • Hussey, M.A.1    Hughes, J.P.2
  • 32
    • 84920952904 scopus 로고    scopus 로고
    • Fielding KL, McCarthy K, Cox H, Erasmus L, Ginindza S, et al. (2014) Xpert as the first-line TB test in South Africa: yield, initial loss to follow-up, proportion treated [abstract]. 2014 Conference on Retroviruses and Opportunistic Infections; 3–6 March 2014; Boston, Massachusetts, US
    • Fielding KL, McCarthy K, Cox H, Erasmus L, Ginindza S, et al. (2014) Xpert as the first-line TB test in South Africa: yield, initial loss to follow-up, proportion treated [abstract]. 2014 Conference on Retroviruses and Opportunistic Infections; 3–6 March 2014; Boston, Massachusetts, US.
  • 33
    • 84901058039 scopus 로고    scopus 로고
    • Do high rates of empirical treatment undermine the potential effect of new diagnostic tests for tuberculosis in high-burden settings?
    • Theron G, Peter J, Dowdy D, Langley I, Squire SB, et al. (2014) Do high rates of empirical treatment undermine the potential effect of new diagnostic tests for tuberculosis in high-burden settings? Lancet Infect Dis 14: 527–532.
    • (2014) Lancet Infect Dis , vol.14 , pp. 527-532
    • Theron, G.1    Peter, J.2    Dowdy, D.3    Langley, I.4    Squire, S.B.5
  • 34
    • 84920952903 scopus 로고    scopus 로고
    • World Health Organization (2007) Improving the diagnosis and treatment of smear-negative pulmonary and extra-pulmonary tuberculosis among adults and adolescents: recommendations for HIV-prevalent and resource-constrained settings. Available: http://www.who.int/hiv/pub/tb/pulmonary/en/. Accessed 5 March 2014.
  • 35
    • 84886470418 scopus 로고    scopus 로고
    • Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis
    • Walusimbi S, Bwanga F, De Costa A, Haile M, Joloba M, et al. (2013) Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis. BMC Infect Dis 13: 507.
    • (2013) BMC Infect Dis , vol.13 , pp. 507
    • Walusimbi, S.1    Bwanga, F.2    De Costa, A.3    Haile, M.4    Joloba, M.5
  • 36
    • 69149088344 scopus 로고    scopus 로고
    • Uses of tuberculosis mortality surveillance to identify programme errors and improve database reporting
    • Selig L, Guedes R, Kritski A, Spector N, Lapa E, Silva JR, et al. (2009) Uses of tuberculosis mortality surveillance to identify programme errors and improve database reporting. Int J Tuberc Lung Dis 13: 982–988.
    • (2009) Int J Tuberc Lung Dis , vol.13 , pp. 982-988
    • Selig, L.1    Guedes, R.2    Kritski, A.3    Spector, N.4    Lapa, E.5    Silva, J.R.6
  • 37
    • 78650480386 scopus 로고    scopus 로고
    • Óbitos e internações por tuberculose não notificados no Município do Rio de Janeiro
    • Oliveira LM, PinheiroII RS, (2011) Óbitos e internações por tuberculose não notificados no Município do Rio de Janeiro. Rev Saude Publica 45: 31–39.
    • (2011) Rev Saude Publica , vol.45 , pp. 31-39
    • Oliveira, L.M.1    PinheiroII, R.S.2
  • 39
    • 80054978377 scopus 로고    scopus 로고
    • Studies with staggered starts: multiple baseline designs and group-randomized trials
    • Rhoda DA, Murray DM, Andridge RR, Pennell ML, Hade EM, (2011) Studies with staggered starts: multiple baseline designs and group-randomized trials. Am J Public Health 101: 2164–2169 doi:10.2105/AJPH.2011.300264
    • (2011) Am J Public Health , vol.101 , pp. 2164-2169
    • Rhoda, D.A.1    Murray, D.M.2    Andridge, R.R.3    Pennell, M.L.4    Hade, E.M.5
  • 40
    • 79960509329 scopus 로고    scopus 로고
    • Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting
    • Theron G, Peter J, van Zyl-Smit R, Mishra H, Streicher E, et al. (2011) Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med 184: 132–140 doi:10.1164/rccm.201101-0056OC
    • (2011) Am J Respir Crit Care Med , vol.184 , pp. 132-140
    • Theron, G.1    Peter, J.2    van Zyl-Smit, R.3    Mishra, H.4    Streicher, E.5
  • 41
    • 84920952902 scopus 로고    scopus 로고
    • Foundation for Innovative New Diagnostics (2011) Performance of Xpert MTB/RIF version G4 assay. Geneva: Foundation for Innovative New Diagnostics. Available: http://www.stoptb.org/wg/gli/assets/documents/map/findg4cartridge.pdf. Accessed 2 February 2014.
  • 42
    • 84893120416 scopus 로고    scopus 로고
    • GeneXpert MTB/RIF version G4 for identification of rifampin-resistant tuberculosis in a programmatic setting
    • Osman M, Simpson JA, Caldwell J, Bosman M, Nicol MP, (2014) GeneXpert MTB/RIF version G4 for identification of rifampin-resistant tuberculosis in a programmatic setting. J Clin Microbiol 52: 635–637 doi:10.1128/JCM.02517-13
    • (2014) J Clin Microbiol , vol.52 , pp. 635-637
    • Osman, M.1    Simpson, J.A.2    Caldwell, J.3    Bosman, M.4    Nicol, M.P.5
  • 43
    • 84880609116 scopus 로고    scopus 로고
    • Rifampin drug resistance tests for tuberculosis: challenging the gold standard
    • Van Deun A, Aung KJM, Bola V, Lebeke R, Hossain MA, et al. (2013) Rifampin drug resistance tests for tuberculosis: challenging the gold standard. J Clin Microbiol 51: 2633–2640 doi:10.1128/JCM.00553-13
    • (2013) J Clin Microbiol , vol.51 , pp. 2633-2640
    • Van Deun, A.1    Aung, K.J.M.2    Bola, V.3    Lebeke, R.4    Hossain, M.A.5
  • 44
    • 84901684438 scopus 로고    scopus 로고
    • Comparison of Xpert MTB/RIF with line probe assay for detection of rifampin-monoresistant Mycobacterium tuberculosis
    • Rufai SB, Kumar P, Singh A, Prajapati S, Balooni V, et al. (2014) Comparison of Xpert MTB/RIF with line probe assay for detection of rifampin-monoresistant Mycobacterium tuberculosis. J Clin Microbiol 52: 1846–1852 doi:10.1128/JCM.03005-13
    • (2014) J Clin Microbiol , vol.52 , pp. 1846-1852
    • Rufai, S.B.1    Kumar, P.2    Singh, A.3    Prajapati, S.4    Balooni, V.5
  • 45
    • 84902336700 scopus 로고    scopus 로고
    • Diagnostic accuracy and turnaround time of the Xpert MTB/RIF assay in routine clinical practice
    • Kwak N, Choi SM, Lee J, Park YS, Lee C-H, et al. (2013) Diagnostic accuracy and turnaround time of the Xpert MTB/RIF assay in routine clinical practice. PLoS ONE 8: e77456 doi:10.1371/journal.pone.0077456
    • (2013) PLoS ONE , vol.8 , pp. e77456
    • Kwak, N.1    Choi, S.M.2    Lee, J.3    Park, Y.S.4    Lee, C.-H.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.