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Liquid vs Solid Culture Medium to Evaluate Proportion and Time to Change in Management of Suspects of Tuberculosis-A Pragmatic Randomized Trial in Secondary and Tertiary Health Care Units in Brazil
The use of liquid medium (MGIT960) for tuberculosis (TB) diagnosis was recommended by WHO in 2007. However, there has been no evaluation of its effectiveness on clinically important outcomes. A pragmatic trial was carried out in a tertiary hospital and a secondary health care unit in Rio de Janeiro...
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| Published in: | PloS one 2015-06, Vol.10 (6), p.e0127588-e0127588 |
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| creator | Moreira, Adriana da Silva Rezende Huf, Gisele Vieira, Maria Armanda Monteiro da Silva Costa, Paulo Albuquerque da Aguiar, Fábio Marsico, Anna Grazia Fonseca, Leila de Souza Ricks, Mônica Oliveira, Martha Maria Detjen, Anne Fujiwara, Paula Isono Squire, Stephen Bertel Kritski, Afranio Lineu |
| description | The use of liquid medium (MGIT960) for tuberculosis (TB) diagnosis was recommended by WHO in 2007. However, there has been no evaluation of its effectiveness on clinically important outcomes.
A pragmatic trial was carried out in a tertiary hospital and a secondary health care unit in Rio de Janeiro City, Brazil. Participants were 16 years or older, suspected of having TB. They were excluded if only cerebral spinal fluid or blood specimens were available for analysis. MGIT960 technique was compared with the Lowenstein-Jensen (LJ) method for laboratory diagnosis of active TB. Primary outcome was the proportion of patients who had their initial medical management changed within 2 months after randomisation. Secondary outcomes were: mean time for changing the procedure, patient satisfaction with the overall treatment and adverse events. Data were analysed by intention-to-treat. Between April 2008 and September 2011, 693 patients were enrolled (348 to MGIT, 345 to LJ). Smear and culture results were positive for 10% and 15.7% of participants, respectively. Patients in the MGIT arm had their initial medical management changed more frequently than those in the LJ group (10.1% MGIT vs 3.8% LJ, RR 2.67 95% CI 1.44-.96, p = 0.002, NNT 16, 95% CI 10-39). Mean time for changing the initial procedure was greater in LJ group at both sites: 20.0 and 29.6 days in MGIT group and 52.2 and 64.3 in LJ group (MD 33.5, 95% CI 30.6-36.4, p = 0.0001). No other important differences were observed.
This study suggests that opting for the MGIT960 system for TB diagnosis provides a promising case management model for improving the quality of care and control of TB.
Controlled-Trials.com ISRCTN79888843. |
| doi_str_mv | 10.1371/journal.pone.0127588 |
| format | article |
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A pragmatic trial was carried out in a tertiary hospital and a secondary health care unit in Rio de Janeiro City, Brazil. Participants were 16 years or older, suspected of having TB. They were excluded if only cerebral spinal fluid or blood specimens were available for analysis. MGIT960 technique was compared with the Lowenstein-Jensen (LJ) method for laboratory diagnosis of active TB. Primary outcome was the proportion of patients who had their initial medical management changed within 2 months after randomisation. Secondary outcomes were: mean time for changing the procedure, patient satisfaction with the overall treatment and adverse events. Data were analysed by intention-to-treat. Between April 2008 and September 2011, 693 patients were enrolled (348 to MGIT, 345 to LJ). Smear and culture results were positive for 10% and 15.7% of participants, respectively. Patients in the MGIT arm had their initial medical management changed more frequently than those in the LJ group (10.1% MGIT vs 3.8% LJ, RR 2.67 95% CI 1.44-.96, p = 0.002, NNT 16, 95% CI 10-39). Mean time for changing the initial procedure was greater in LJ group at both sites: 20.0 and 29.6 days in MGIT group and 52.2 and 64.3 in LJ group (MD 33.5, 95% CI 30.6-36.4, p = 0.0001). No other important differences were observed.
This study suggests that opting for the MGIT960 system for TB diagnosis provides a promising case management model for improving the quality of care and control of TB.
Controlled-Trials.com ISRCTN79888843.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0127588</identifier><identifier>PMID: 26046532</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acids ; Adolescent ; Adult ; Antitubercular Agents - therapeutic use ; Automation ; Bacteriological Techniques ; Brazil ; Cerebrospinal fluid ; Clinical trials ; Comparative analysis ; Data processing ; Diagnosis ; Female ; Health care ; HIV ; Hospitals ; Human immunodeficiency virus ; Humans ; Laboratories ; Low income groups ; Lung diseases ; Male ; Management ; Medical diagnosis ; Medical schools ; Middle Aged ; Motivation ; Mycobacterium tuberculosis ; Mycobacterium tuberculosis - isolation & purification ; Patients ; Randomization ; Reagent Kits, Diagnostic ; Secondary Care ; Smear ; Tertiary Healthcare ; Tuberculosis ; Tuberculosis - diagnosis ; Tuberculosis - drug therapy ; Tuberculosis - microbiology ; Young Adult</subject><ispartof>PloS one, 2015-06, Vol.10 (6), p.e0127588-e0127588</ispartof><rights>COPYRIGHT 2015 Public Library of Science</rights><rights>2015 Moreira et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2015 Moreira et al 2015 Moreira et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-8a4fcd0560714a5f9be4f0e4ca8ab627579a807338fda722251aaa9b464aec2e3</citedby><cites>FETCH-LOGICAL-c692t-8a4fcd0560714a5f9be4f0e4ca8ab627579a807338fda722251aaa9b464aec2e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/1686215033/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/1686215033?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,315,733,786,790,891,25783,27957,27958,37047,37048,44625,53827,53829,75483</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26046532$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Doherty, T. Mark</contributor><creatorcontrib>Moreira, Adriana da Silva Rezende</creatorcontrib><creatorcontrib>Huf, Gisele</creatorcontrib><creatorcontrib>Vieira, Maria Armanda Monteiro da Silva</creatorcontrib><creatorcontrib>Costa, Paulo Albuquerque da</creatorcontrib><creatorcontrib>Aguiar, Fábio</creatorcontrib><creatorcontrib>Marsico, Anna Grazia</creatorcontrib><creatorcontrib>Fonseca, Leila de Souza</creatorcontrib><creatorcontrib>Ricks, Mônica</creatorcontrib><creatorcontrib>Oliveira, Martha Maria</creatorcontrib><creatorcontrib>Detjen, Anne</creatorcontrib><creatorcontrib>Fujiwara, Paula Isono</creatorcontrib><creatorcontrib>Squire, Stephen Bertel</creatorcontrib><creatorcontrib>Kritski, Afranio Lineu</creatorcontrib><title>Liquid vs Solid Culture Medium to Evaluate Proportion and Time to Change in Management of Suspects of Tuberculosis-A Pragmatic Randomized Trial in Secondary and Tertiary Health Care Units in Brazil</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>The use of liquid medium (MGIT960) for tuberculosis (TB) diagnosis was recommended by WHO in 2007. However, there has been no evaluation of its effectiveness on clinically important outcomes.
A pragmatic trial was carried out in a tertiary hospital and a secondary health care unit in Rio de Janeiro City, Brazil. Participants were 16 years or older, suspected of having TB. They were excluded if only cerebral spinal fluid or blood specimens were available for analysis. MGIT960 technique was compared with the Lowenstein-Jensen (LJ) method for laboratory diagnosis of active TB. Primary outcome was the proportion of patients who had their initial medical management changed within 2 months after randomisation. Secondary outcomes were: mean time for changing the procedure, patient satisfaction with the overall treatment and adverse events. Data were analysed by intention-to-treat. Between April 2008 and September 2011, 693 patients were enrolled (348 to MGIT, 345 to LJ). Smear and culture results were positive for 10% and 15.7% of participants, respectively. Patients in the MGIT arm had their initial medical management changed more frequently than those in the LJ group (10.1% MGIT vs 3.8% LJ, RR 2.67 95% CI 1.44-.96, p = 0.002, NNT 16, 95% CI 10-39). Mean time for changing the initial procedure was greater in LJ group at both sites: 20.0 and 29.6 days in MGIT group and 52.2 and 64.3 in LJ group (MD 33.5, 95% CI 30.6-36.4, p = 0.0001). No other important differences were observed.
This study suggests that opting for the MGIT960 system for TB diagnosis provides a promising case management model for improving the quality of care and control of TB.
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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Moreira, Adriana da Silva Rezende</au><au>Huf, Gisele</au><au>Vieira, Maria Armanda Monteiro da Silva</au><au>Costa, Paulo Albuquerque da</au><au>Aguiar, Fábio</au><au>Marsico, Anna Grazia</au><au>Fonseca, Leila de Souza</au><au>Ricks, Mônica</au><au>Oliveira, Martha Maria</au><au>Detjen, Anne</au><au>Fujiwara, Paula Isono</au><au>Squire, Stephen Bertel</au><au>Kritski, Afranio Lineu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liquid vs Solid Culture Medium to Evaluate Proportion and Time to Change in Management of Suspects of Tuberculosis-A Pragmatic Randomized Trial in Secondary and Tertiary Health Care Units in Brazil</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2015-06-05</date><risdate>2015</risdate><volume>10</volume><issue>6</issue><spage>e0127588</spage><epage>e0127588</epage><pages>e0127588-e0127588</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-News-1</notes><notes>ObjectType-Feature-3</notes><notes>content type line 23</notes><notes>Conceived and designed the experiments: GH LSF ALK. Performed the experiments: ASRM MAMV PAC FA AM MR. Analyzed the data: GH ASRM MAMV ALK AD PIF SBS. Contributed reagents/materials/analysis tools: LSF MMO ALK. Wrote the paper: ASRM GH MAMV PAC FA AM MR MMO AD PIF SBS ALK.</notes><notes>Competing Interests: The authors have declared that no competing interests exist.</notes><abstract>The use of liquid medium (MGIT960) for tuberculosis (TB) diagnosis was recommended by WHO in 2007. However, there has been no evaluation of its effectiveness on clinically important outcomes.
A pragmatic trial was carried out in a tertiary hospital and a secondary health care unit in Rio de Janeiro City, Brazil. Participants were 16 years or older, suspected of having TB. They were excluded if only cerebral spinal fluid or blood specimens were available for analysis. MGIT960 technique was compared with the Lowenstein-Jensen (LJ) method for laboratory diagnosis of active TB. Primary outcome was the proportion of patients who had their initial medical management changed within 2 months after randomisation. Secondary outcomes were: mean time for changing the procedure, patient satisfaction with the overall treatment and adverse events. Data were analysed by intention-to-treat. Between April 2008 and September 2011, 693 patients were enrolled (348 to MGIT, 345 to LJ). Smear and culture results were positive for 10% and 15.7% of participants, respectively. Patients in the MGIT arm had their initial medical management changed more frequently than those in the LJ group (10.1% MGIT vs 3.8% LJ, RR 2.67 95% CI 1.44-.96, p = 0.002, NNT 16, 95% CI 10-39). Mean time for changing the initial procedure was greater in LJ group at both sites: 20.0 and 29.6 days in MGIT group and 52.2 and 64.3 in LJ group (MD 33.5, 95% CI 30.6-36.4, p = 0.0001). No other important differences were observed.
This study suggests that opting for the MGIT960 system for TB diagnosis provides a promising case management model for improving the quality of care and control of TB.
Controlled-Trials.com ISRCTN79888843.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>26046532</pmid><doi>10.1371/journal.pone.0127588</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2015-06, Vol.10 (6), p.e0127588-e0127588 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1686215033 |
| source | Publicly Available Content Database; PubMed Central |
| subjects | Acids Adolescent Adult Antitubercular Agents - therapeutic use Automation Bacteriological Techniques Brazil Cerebrospinal fluid Clinical trials Comparative analysis Data processing Diagnosis Female Health care HIV Hospitals Human immunodeficiency virus Humans Laboratories Low income groups Lung diseases Male Management Medical diagnosis Medical schools Middle Aged Motivation Mycobacterium tuberculosis Mycobacterium tuberculosis - isolation & purification Patients Randomization Reagent Kits, Diagnostic Secondary Care Smear Tertiary Healthcare Tuberculosis Tuberculosis - diagnosis Tuberculosis - drug therapy Tuberculosis - microbiology Young Adult |
| title | Liquid vs Solid Culture Medium to Evaluate Proportion and Time to Change in Management of Suspects of Tuberculosis-A Pragmatic Randomized Trial in Secondary and Tertiary Health Care Units in Brazil |
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