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

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Cuevas, Luis ORCID: https://orcid.org/0000-0002-6581-0587, Yassin, Mohammed A., 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, Gregory, Anderson de Cuevas, Rachel Mary, Kremer, Kristin, van Soolingen, Dick, Nathanson, Carl-Michael, Joly, Jean, Faragher, Brian, Squire, Bertie ORCID: https://orcid.org/0000-0001-7173-9038 and Ramsay, Andrew (2011) 'A Multi-Country Non-Inferiority Cluster Randomized Trial of Frontloaded Smear Microscopy for the Diagnosis of Pulmonary Tuberculosis'. PLoS Medicine, Vol 8, Issue 7, e1000443.

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Abstract

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.

Item Type: Article
Additional Information: Copyright: © 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.
Subjects: WF Respiratory System > WF 20 Research (General)
WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)
WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
WF Respiratory System > Tuberculosis > WF 300 Pulmonary tuberculosis
Faculty: Department: Groups (2002 - 2012) > Clinical Group
Digital Object Identifer (DOI): https://doi.org/10.1371/journal.pmed.1000443
Depositing User: Users 379 not found.
Date Deposited: 24 Oct 2012 16:22
Last Modified: 06 Feb 2018 13:05
URI: https://archive.lstmed.ac.uk/id/eprint/3067

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