A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis.
<h4>Background</h4>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.<h4>Methods and findings</h4>This clinical trial of adults with cough ≥2...
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oai:doaj.org-article:fcd0c088028a40928ef06bee045e9b1c2021-11-18T05:41:46ZA multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis.1549-12771549-167610.1371/journal.pmed.1000443https://doaj.org/article/fcd0c088028a40928ef06bee045e9b1c2011-07-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21765808/?tool=EBIhttps://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676<h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Current Controlled Trials ISRCTN53339491. Please see later in the article for the Editors' Summary.Luis Eduardo CuevasMohammed Ahmed YassinNajla Al-SonboliLovett LawsonIsabel ArbideNasher Al-AghbariJeevan Bahadur SherchandAmin Al-AbsiEmmanuel Nnamdi EmenyonuYared MeridMosis Ifenyi OkobiJuliana Olubunmi OnuohaMelkamsew AschalewAbraham AseffaGreg HarperRachel Mary Anderson de CuevasKristin KremerDick van SoolingenCarl-Michael NathansonJean JolyBrian FaragherStephen Bertel SquireAndrew RamsayPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 8, Iss 7, p e1000443 (2011) |
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Medicine R Luis Eduardo Cuevas Mohammed Ahmed Yassin Najla Al-Sonboli Lovett Lawson Isabel Arbide Nasher Al-Aghbari Jeevan Bahadur Sherchand Amin Al-Absi Emmanuel Nnamdi Emenyonu Yared Merid Mosis Ifenyi Okobi Juliana Olubunmi Onuoha Melkamsew Aschalew Abraham Aseffa Greg Harper Rachel Mary Anderson de Cuevas Kristin Kremer Dick van Soolingen Carl-Michael Nathanson Jean Joly Brian Faragher Stephen Bertel Squire Andrew Ramsay A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis. |
| description |
<h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Current Controlled Trials ISRCTN53339491. Please see later in the article for the Editors' Summary. |
| format |
article |
| author |
Luis Eduardo Cuevas Mohammed Ahmed Yassin Najla Al-Sonboli Lovett Lawson Isabel Arbide Nasher Al-Aghbari Jeevan Bahadur Sherchand Amin Al-Absi Emmanuel Nnamdi Emenyonu Yared Merid Mosis Ifenyi Okobi Juliana Olubunmi Onuoha Melkamsew Aschalew Abraham Aseffa Greg Harper Rachel Mary Anderson de Cuevas Kristin Kremer Dick van Soolingen Carl-Michael Nathanson Jean Joly Brian Faragher Stephen Bertel Squire Andrew Ramsay |
| author_facet |
Luis Eduardo Cuevas Mohammed Ahmed Yassin Najla Al-Sonboli Lovett Lawson Isabel Arbide Nasher Al-Aghbari Jeevan Bahadur Sherchand Amin Al-Absi Emmanuel Nnamdi Emenyonu Yared Merid Mosis Ifenyi Okobi Juliana Olubunmi Onuoha Melkamsew Aschalew Abraham Aseffa Greg Harper Rachel Mary Anderson de Cuevas Kristin Kremer Dick van Soolingen Carl-Michael Nathanson Jean Joly Brian Faragher Stephen Bertel Squire Andrew Ramsay |
| author_sort |
Luis Eduardo Cuevas |
| title |
A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis. |
| title_short |
A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis. |
| title_full |
A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis. |
| title_fullStr |
A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis. |
| title_full_unstemmed |
A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis. |
| title_sort |
multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2011 |
| url |
https://doaj.org/article/fcd0c088028a40928ef06bee045e9b1c |
| work_keys_str_mv |
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