A Multi-Country Non-Inferiority Cluster Randomized Trial of Frontloaded Smear Microscopy for the Diagnosis of Pulmonary Tuberculosis

BACKGROUND: 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. METHODS AND FINDINGS: This clinical trial of adults with cough ≥2 wk duration (in Ethiopia, Nepal, Nig...

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Detalles Bibliográficos
Autores principales: Cuevas, Luis Eduardo, Yassin, Mohammed Ahmed, Al-Sonboli, Najla, Lawson, Lovett, Arbide, Isabel, Al-Aghbari, Nasher, Bahadur Sherchand, Jeevan, Al-Absi, Amin, Emenyonu, Emmanuel Nnamdi, Merid, Yared, Okobi, Mosis Ifenyi, Onuoha, Juliana Olubunmi, Aschalew, Melkamsew, Aseffa, Abraham, Harper, Greg, Anderson de Cuevas, Rachel Mary, Kremer, Kristin, van Soolingen, Dick, Nathanson, Carl-Michael, Joly, Jean, Faragher, Brian, Squire, Stephen Bertel, Ramsay, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2011
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3134460/
https://www.ncbi.nlm.nih.gov/pubmed/21765808
http://dx.doi.org/10.1371/journal.pmed.1000443
Descripción
Sumario:BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53339491 Please see later in the article for the Editors' Summary

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