A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis
More than 50 million people around the world are investigated for tuberculosis using sputum smear microscopy annually. This process requires repeated visits and patients often drop out. This clinical trial of adults with cough ≥2 wk duration (in Ethiopia, Nepal, Nigeria, and Yemen) compared the sens...
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| Veröffentlicht in: | PLoS medicine 2011-07, Vol.8 (7), p.e1000443-e1000443 |
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| creator | Cuevas, Luis Eduardo Yassin, Mohammed Ahmed Al-Sonboli, Najla Lawson, Lovett Arbide, Isabel Al-Aghbari, Nasher Sherchand, Jeevan Bahadur Al-Absi, Amin Emenyonu, Emmanuel Nnamdi Merid, Yared Okobi, Mosis Ifenyi Onuoha, Juliana Olubunmi Aschalew, Melkamsew Aseffa, Abraham Harper, Greg de Cuevas, Rachel Mary Anderson Kremer, Kristin van Soolingen, Dick Nathanson, Carl-Michael Joly, Jean Faragher, Brian Squire, Stephen Bertel Ramsay, Andrew |
| description | More than 50 million people around the world are investigated for tuberculosis using sputum smear microscopy annually. This process requires repeated visits and patients often drop out.
This clinical trial of adults with cough ≥2 wk duration (in Ethiopia, Nepal, Nigeria, and Yemen) compared the sensitivity/specificity of two sputum samples collected "on the spot" during the first visit plus one sputum sample collected the following morning (spot-spot-morning [SSM]) versus the standard spot-morning-spot (SMS) scheme. Analyses were per protocol analysis (PPA) and intention to treat (ITT). A sub-analysis compared just the first two smears of each scheme, spot-spot and spot-morning. In total, 6,627 patients (3,052 SSM/3,575 SMS) were enrolled; 6,466 had culture and 1,526 were culture-positive. The sensitivity of SSM (ITT, 70.2%, 95% CI 66.5%-73.9%) was non-inferior to the sensitivity of SMS (PPA, 65.9%, 95% CI 62.3%-69.5%). Similarly, the specificity of SSM (ITT, 96.9%, 95% CI 93.2%-99.9%) was non-inferior to the specificity of SMS (ITT, 97.6%, 95% CI 94.0%-99.9%). The sensitivity of spot-spot (ITT, 63.6%, 95% CI 59.7%-67.5%) was also non-inferior to spot-morning (ITT, 64.8%, 95% CI 61.3%-68.3%), as the difference was within the selected -5% non-inferiority limit (difference ITT = 1.4%, 95% CI -3.7% to 6.6%). Patients screened using the SSM scheme were more likely to provide the first two specimens than patients screened with the SMS scheme (98% versus 94.2%, p |
| doi_str_mv | 10.1371/journal.pmed.1000443 |
| format | Article |
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This clinical trial of adults with cough ≥2 wk duration (in Ethiopia, Nepal, Nigeria, and Yemen) compared the sensitivity/specificity of two sputum samples collected "on the spot" during the first visit plus one sputum sample collected the following morning (spot-spot-morning [SSM]) versus the standard spot-morning-spot (SMS) scheme. Analyses were per protocol analysis (PPA) and intention to treat (ITT). A sub-analysis compared just the first two smears of each scheme, spot-spot and spot-morning. In total, 6,627 patients (3,052 SSM/3,575 SMS) were enrolled; 6,466 had culture and 1,526 were culture-positive. The sensitivity of SSM (ITT, 70.2%, 95% CI 66.5%-73.9%) was non-inferior to the sensitivity of SMS (PPA, 65.9%, 95% CI 62.3%-69.5%). Similarly, the specificity of SSM (ITT, 96.9%, 95% CI 93.2%-99.9%) was non-inferior to the specificity of SMS (ITT, 97.6%, 95% CI 94.0%-99.9%). The sensitivity of spot-spot (ITT, 63.6%, 95% CI 59.7%-67.5%) was also non-inferior to spot-morning (ITT, 64.8%, 95% CI 61.3%-68.3%), as the difference was within the selected -5% non-inferiority limit (difference ITT = 1.4%, 95% CI -3.7% to 6.6%). Patients screened using the SSM scheme were more likely to provide the first two specimens than patients screened with the SMS scheme (98% versus 94.2%, p<0.01). The PPA and ITT analysis resulted in similar results.
The sensitivity and specificity of SSM are non-inferior to those of SMS, with a higher proportion of patients submitting specimens. The scheme identifies most smear-positive patients on the first day of consultation.
Current Controlled Trials ISRCTN53339491. Please see later in the article for the Editors' Summary.</description><identifier>ISSN: 1549-1676</identifier><identifier>ISSN: 1549-1277</identifier><identifier>EISSN: 1549-1676</identifier><identifier>DOI: 10.1371/journal.pmed.1000443</identifier><identifier>PMID: 21765808</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Cluster Analysis ; Cough - etiology ; Diagnosis ; Female ; Humans ; Infectious Diseases ; Infectious Diseases/Respiratory Infections ; Intention to Treat Analysis ; Low income groups ; Lungs ; Male ; Mass Screening - methods ; Microscope and microscopy ; Microscopy ; Microscopy - methods ; Middle Aged ; Mycobacterium ; Mycobacterium tuberculosis - isolation & purification ; Patient Compliance ; Sensitivity and Specificity ; Specimen Handling - methods ; Sputum - microbiology ; Tuberculosis ; Tuberculosis, Pulmonary - complications ; Tuberculosis, Pulmonary - diagnosis ; Tuberculosis, Pulmonary - microbiology ; Young Adult</subject><ispartof>PLoS medicine, 2011-07, Vol.8 (7), p.e1000443-e1000443</ispartof><rights>COPYRIGHT 2011 Public Library of Science</rights><rights>2011 World Health Organization; licensee Public Library of Science (PLoS). This is an Open Access article in the spirit of the Public Library of Science (PLoS) principles for Open Access http://www.plos.org/oa/, without any waiver of WHO's privileges and immunities under international law, convention, or agreement. This article should not be reproduced for use in association with the promotion of commercial products, services, or any legal entity. There should be no suggestion that WHO endorses any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL. Citation: Cuevas LE, Yassin MA, Al-Sonboli N, Lawson L, Arbide I, et al. (2011) A Multi-Country Non-Inferiority Cluster Randomized Trial of Frontloaded Smear Microscopy for the Diagnosis of Pulmonary Tuberculosis. PLoS Med 8(7): e1000443. doi:10.1371/journal.pmed.1000443</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c861t-38e57139d92a5c73272735f54d22413326512b7d19c2898fe8c31e9af8e936f3</citedby><cites>FETCH-LOGICAL-c861t-38e57139d92a5c73272735f54d22413326512b7d19c2898fe8c31e9af8e936f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3134460/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3134460/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21765808$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Murray, Megan</contributor><creatorcontrib>Cuevas, Luis Eduardo</creatorcontrib><creatorcontrib>Yassin, Mohammed Ahmed</creatorcontrib><creatorcontrib>Al-Sonboli, Najla</creatorcontrib><creatorcontrib>Lawson, Lovett</creatorcontrib><creatorcontrib>Arbide, Isabel</creatorcontrib><creatorcontrib>Al-Aghbari, Nasher</creatorcontrib><creatorcontrib>Sherchand, Jeevan Bahadur</creatorcontrib><creatorcontrib>Al-Absi, Amin</creatorcontrib><creatorcontrib>Emenyonu, Emmanuel Nnamdi</creatorcontrib><creatorcontrib>Merid, Yared</creatorcontrib><creatorcontrib>Okobi, Mosis Ifenyi</creatorcontrib><creatorcontrib>Onuoha, Juliana Olubunmi</creatorcontrib><creatorcontrib>Aschalew, Melkamsew</creatorcontrib><creatorcontrib>Aseffa, Abraham</creatorcontrib><creatorcontrib>Harper, Greg</creatorcontrib><creatorcontrib>de Cuevas, Rachel Mary Anderson</creatorcontrib><creatorcontrib>Kremer, Kristin</creatorcontrib><creatorcontrib>van Soolingen, Dick</creatorcontrib><creatorcontrib>Nathanson, Carl-Michael</creatorcontrib><creatorcontrib>Joly, Jean</creatorcontrib><creatorcontrib>Faragher, Brian</creatorcontrib><creatorcontrib>Squire, Stephen Bertel</creatorcontrib><creatorcontrib>Ramsay, Andrew</creatorcontrib><title>A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis</title><title>PLoS medicine</title><addtitle>PLoS Med</addtitle><description>More than 50 million people around the world are investigated for tuberculosis using sputum smear microscopy annually. This process requires repeated visits and patients often drop out.
This clinical trial of adults with cough ≥2 wk duration (in Ethiopia, Nepal, Nigeria, and Yemen) compared the sensitivity/specificity of two sputum samples collected "on the spot" during the first visit plus one sputum sample collected the following morning (spot-spot-morning [SSM]) versus the standard spot-morning-spot (SMS) scheme. Analyses were per protocol analysis (PPA) and intention to treat (ITT). A sub-analysis compared just the first two smears of each scheme, spot-spot and spot-morning. In total, 6,627 patients (3,052 SSM/3,575 SMS) were enrolled; 6,466 had culture and 1,526 were culture-positive. The sensitivity of SSM (ITT, 70.2%, 95% CI 66.5%-73.9%) was non-inferior to the sensitivity of SMS (PPA, 65.9%, 95% CI 62.3%-69.5%). Similarly, the specificity of SSM (ITT, 96.9%, 95% CI 93.2%-99.9%) was non-inferior to the specificity of SMS (ITT, 97.6%, 95% CI 94.0%-99.9%). The sensitivity of spot-spot (ITT, 63.6%, 95% CI 59.7%-67.5%) was also non-inferior to spot-morning (ITT, 64.8%, 95% CI 61.3%-68.3%), as the difference was within the selected -5% non-inferiority limit (difference ITT = 1.4%, 95% CI -3.7% to 6.6%). Patients screened using the SSM scheme were more likely to provide the first two specimens than patients screened with the SMS scheme (98% versus 94.2%, p<0.01). The PPA and ITT analysis resulted in similar results.
The sensitivity and specificity of SSM are non-inferior to those of SMS, with a higher proportion of patients submitting specimens. The scheme identifies most smear-positive patients on the first day of consultation.
Current Controlled Trials ISRCTN53339491. Please see later in the article for the Editors' Summary.</description><subject>Adult</subject><subject>Cluster Analysis</subject><subject>Cough - etiology</subject><subject>Diagnosis</subject><subject>Female</subject><subject>Humans</subject><subject>Infectious Diseases</subject><subject>Infectious Diseases/Respiratory Infections</subject><subject>Intention to Treat Analysis</subject><subject>Low income groups</subject><subject>Lungs</subject><subject>Male</subject><subject>Mass Screening - methods</subject><subject>Microscope and microscopy</subject><subject>Microscopy</subject><subject>Microscopy - methods</subject><subject>Middle Aged</subject><subject>Mycobacterium</subject><subject>Mycobacterium tuberculosis - isolation & purification</subject><subject>Patient Compliance</subject><subject>Sensitivity and Specificity</subject><subject>Specimen Handling - methods</subject><subject>Sputum - microbiology</subject><subject>Tuberculosis</subject><subject>Tuberculosis, Pulmonary - complications</subject><subject>Tuberculosis, Pulmonary - diagnosis</subject><subject>Tuberculosis, Pulmonary - microbiology</subject><subject>Young Adult</subject><issn>1549-1676</issn><issn>1549-1277</issn><issn>1549-1676</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNqVk12LEzEUhgdR3HX1H4gOCIoXU_MxH8mNUBY_CosLungb0sxJmyWTdJOMWK_94aa2u7RSUJmLDCfP-56Tk5yieIrRBNMOv7n2Y3DSTlYD9BOMEKpreq84xU3NK9x27f29_5PiUYzXCBGOOHpYnBDctQ1D7LT4OS2H0SZTKT-6FNal864yTkMwPpi0LpUdY4JQBul6P5gf0JcpGGlLr0sdvEvWyz4H4wAylINRwUflV-tS-1CmJZS9kQvno4kbxWq0g3cy50njHIIa7WbncfFASxvhyW49K67ev7s6_1hdXH6YnU8vKsVanCrKoOkw5T0nslEdJR3paKObuiekxpSStsFk3vWYK8I408AUxcClZsBpq-lZ8Xxru8pZxa5_UWDCGOINbUgmZlui9_JarIIZcqnCSyN-B3xYCBmSURaEVj1SKCsJkzXihIFG7RwA1Q3wOVbZ6-0u2zjPV6Qgt1faA9PDHWeWYuG_CYppXbcoG7zaGQR_M0JMYjBRgbXSgR-jYJzjmhFO_k52uUzOSZvJF3-Qx9uwoxYynzS_Bp8LVBtPMc0mHWu6rs5UdYRagIN8Gu9Amxw-4CdH-Pz1kJ_NUcHrA0FmEnxPCznGKGZfPv8H--nf2cuvh-zLPXYJ0qZl9HZMxrt4CNZbcDMAMYC-u2mMxGZgbzstNgMrdgObZc_2X8md6HZC6S8uAzu3</recordid><startdate>20110701</startdate><enddate>20110701</enddate><creator>Cuevas, Luis Eduardo</creator><creator>Yassin, Mohammed Ahmed</creator><creator>Al-Sonboli, Najla</creator><creator>Lawson, Lovett</creator><creator>Arbide, Isabel</creator><creator>Al-Aghbari, Nasher</creator><creator>Sherchand, Jeevan Bahadur</creator><creator>Al-Absi, Amin</creator><creator>Emenyonu, Emmanuel Nnamdi</creator><creator>Merid, Yared</creator><creator>Okobi, Mosis Ifenyi</creator><creator>Onuoha, Juliana Olubunmi</creator><creator>Aschalew, Melkamsew</creator><creator>Aseffa, Abraham</creator><creator>Harper, Greg</creator><creator>de Cuevas, Rachel Mary Anderson</creator><creator>Kremer, Kristin</creator><creator>van Soolingen, Dick</creator><creator>Nathanson, Carl-Michael</creator><creator>Joly, Jean</creator><creator>Faragher, Brian</creator><creator>Squire, Stephen Bertel</creator><creator>Ramsay, Andrew</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISN</scope><scope>ISR</scope><scope>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>7QL</scope><scope>C1K</scope><scope>5PM</scope><scope>DOA</scope><scope>CZK</scope></search><sort><creationdate>20110701</creationdate><title>A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis</title><author>Cuevas, Luis Eduardo ; Yassin, Mohammed Ahmed ; Al-Sonboli, Najla ; Lawson, Lovett ; Arbide, Isabel ; Al-Aghbari, Nasher ; Sherchand, Jeevan Bahadur ; Al-Absi, Amin ; Emenyonu, Emmanuel Nnamdi ; Merid, Yared ; Okobi, Mosis Ifenyi ; Onuoha, Juliana Olubunmi ; Aschalew, Melkamsew ; Aseffa, Abraham ; Harper, Greg ; de Cuevas, Rachel Mary Anderson ; Kremer, Kristin ; van Soolingen, Dick ; Nathanson, Carl-Michael ; Joly, Jean ; Faragher, Brian ; Squire, Stephen Bertel ; Ramsay, Andrew</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c861t-38e57139d92a5c73272735f54d22413326512b7d19c2898fe8c31e9af8e936f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Cluster Analysis</topic><topic>Cough - 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Academic</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Environmental Sciences and Pollution Management</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><collection>PLoS Medicine</collection><jtitle>PLoS medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cuevas, Luis Eduardo</au><au>Yassin, Mohammed Ahmed</au><au>Al-Sonboli, Najla</au><au>Lawson, Lovett</au><au>Arbide, Isabel</au><au>Al-Aghbari, Nasher</au><au>Sherchand, Jeevan Bahadur</au><au>Al-Absi, Amin</au><au>Emenyonu, Emmanuel Nnamdi</au><au>Merid, Yared</au><au>Okobi, Mosis Ifenyi</au><au>Onuoha, Juliana Olubunmi</au><au>Aschalew, Melkamsew</au><au>Aseffa, Abraham</au><au>Harper, Greg</au><au>de Cuevas, Rachel Mary Anderson</au><au>Kremer, Kristin</au><au>van Soolingen, Dick</au><au>Nathanson, Carl-Michael</au><au>Joly, Jean</au><au>Faragher, Brian</au><au>Squire, Stephen Bertel</au><au>Ramsay, Andrew</au><au>Murray, Megan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis</atitle><jtitle>PLoS medicine</jtitle><addtitle>PLoS Med</addtitle><date>2011-07-01</date><risdate>2011</risdate><volume>8</volume><issue>7</issue><spage>e1000443</spage><epage>e1000443</epage><pages>e1000443-e1000443</pages><issn>1549-1676</issn><issn>1549-1277</issn><eissn>1549-1676</eissn><abstract>More than 50 million people around the world are investigated for tuberculosis using sputum smear microscopy annually. This process requires repeated visits and patients often drop out.
This clinical trial of adults with cough ≥2 wk duration (in Ethiopia, Nepal, Nigeria, and Yemen) compared the sensitivity/specificity of two sputum samples collected "on the spot" during the first visit plus one sputum sample collected the following morning (spot-spot-morning [SSM]) versus the standard spot-morning-spot (SMS) scheme. Analyses were per protocol analysis (PPA) and intention to treat (ITT). A sub-analysis compared just the first two smears of each scheme, spot-spot and spot-morning. In total, 6,627 patients (3,052 SSM/3,575 SMS) were enrolled; 6,466 had culture and 1,526 were culture-positive. The sensitivity of SSM (ITT, 70.2%, 95% CI 66.5%-73.9%) was non-inferior to the sensitivity of SMS (PPA, 65.9%, 95% CI 62.3%-69.5%). Similarly, the specificity of SSM (ITT, 96.9%, 95% CI 93.2%-99.9%) was non-inferior to the specificity of SMS (ITT, 97.6%, 95% CI 94.0%-99.9%). The sensitivity of spot-spot (ITT, 63.6%, 95% CI 59.7%-67.5%) was also non-inferior to spot-morning (ITT, 64.8%, 95% CI 61.3%-68.3%), as the difference was within the selected -5% non-inferiority limit (difference ITT = 1.4%, 95% CI -3.7% to 6.6%). Patients screened using the SSM scheme were more likely to provide the first two specimens than patients screened with the SMS scheme (98% versus 94.2%, p<0.01). The PPA and ITT analysis resulted in similar results.
The sensitivity and specificity of SSM are non-inferior to those of SMS, with a higher proportion of patients submitting specimens. The scheme identifies most smear-positive patients on the first day of consultation.
Current Controlled Trials ISRCTN53339491. Please see later in the article for the Editors' Summary.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>21765808</pmid><doi>10.1371/journal.pmed.1000443</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1549-1676 |
| ispartof | PLoS medicine, 2011-07, Vol.8 (7), p.e1000443-e1000443 |
| issn | 1549-1676 1549-1277 1549-1676 |
| language | eng |
| recordid | cdi_plos_journals_1288095352 |
| source | Public Library of Science (PLoS) Journals Open Access; MEDLINE; PubMed Central（OA）; DOAJ Directory of Open Access Journals; Free E-Journal (出版社公開部分のみ） |
| subjects | Adult Cluster Analysis Cough - etiology Diagnosis Female Humans Infectious Diseases Infectious Diseases/Respiratory Infections Intention to Treat Analysis Low income groups Lungs Male Mass Screening - methods Microscope and microscopy Microscopy Microscopy - methods Middle Aged Mycobacterium Mycobacterium tuberculosis - isolation & purification Patient Compliance Sensitivity and Specificity Specimen Handling - methods Sputum - microbiology Tuberculosis Tuberculosis, Pulmonary - complications Tuberculosis, Pulmonary - diagnosis Tuberculosis, Pulmonary - microbiology Young Adult |
| title | A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis |
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