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Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial

Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial
Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial
Background: tuberculosis control in sub-Saharan Africa has long been hampered by poor diagnostics and weak health systems. New molecular diagnostics, such as the Xpert® MTB/RIF assay, have the potential to improve patient outcomes. We present a cluster randomised trial designed to evaluate whether the positioning of this diagnostic system within the health system has an impact on important patient-level outcomes.

Methods/Design: this pragmatic cluster randomised clinical trial compared two positioning strategies for the Xpert MTB/RIF system: centralised laboratory versus primary health care clinic. The cluster (unit of randomisation) is a 2-week time block at the trial clinic. Adult pulmonary tuberculosis suspects with confirmed human immunodeficiency virus infection and/or at high risk of multidrug-resistant tuberculosis are enrolled from the primary health care clinic. The primary outcome measure is the proportion of culture-confirmed pulmonary tuberculosis cases initiated on appropriate treatment within 30 days of initial clinic visit. Univariate logistic regression will be performed as the primary analysis using generalised estimating equations with a binomial distribution function and a logit link.

Conclusion: diagnostic research tends to focus only on performance of diagnostic tests rather than on patient-important outcomes. This trial has been designed to improve the quality of evidence around diagnostic strategies and to inform the scale-up of new tuberculosis diagnostics within public health systems in high-burden settings
1745-6215
170
Lessells, Richard J.
a1f066e7-ad3c-4050-b91f-91193e19f9df
Cooke, Graham S.
1bd80532-65e2-4155-8e3e-f96432b7e72a
McGrath, Nuala
b75c0232-24ec-443f-93a9-69e9e12dc961
Nicol, Mark P.
a4f984dd-458f-436b-bb4f-ec3470f5977e
Newell, Marie-Louise
c6ff99dd-c23b-4fef-a846-a221fe2522b3
Godfrey-Fausett, Peter
6723f4f5-05d6-49dc-83bb-b40587003a96
Lessells, Richard J.
a1f066e7-ad3c-4050-b91f-91193e19f9df
Cooke, Graham S.
1bd80532-65e2-4155-8e3e-f96432b7e72a
McGrath, Nuala
b75c0232-24ec-443f-93a9-69e9e12dc961
Nicol, Mark P.
a4f984dd-458f-436b-bb4f-ec3470f5977e
Newell, Marie-Louise
c6ff99dd-c23b-4fef-a846-a221fe2522b3
Godfrey-Fausett, Peter
6723f4f5-05d6-49dc-83bb-b40587003a96

Lessells, Richard J., Cooke, Graham S., McGrath, Nuala, Nicol, Mark P., Newell, Marie-Louise and Godfrey-Fausett, Peter (2013) Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial. Trials, 14, 170. (doi:10.1186/1745-6215-14-170). (PMID:23758662)

Record type: Article

Abstract

Background: tuberculosis control in sub-Saharan Africa has long been hampered by poor diagnostics and weak health systems. New molecular diagnostics, such as the Xpert® MTB/RIF assay, have the potential to improve patient outcomes. We present a cluster randomised trial designed to evaluate whether the positioning of this diagnostic system within the health system has an impact on important patient-level outcomes.

Methods/Design: this pragmatic cluster randomised clinical trial compared two positioning strategies for the Xpert MTB/RIF system: centralised laboratory versus primary health care clinic. The cluster (unit of randomisation) is a 2-week time block at the trial clinic. Adult pulmonary tuberculosis suspects with confirmed human immunodeficiency virus infection and/or at high risk of multidrug-resistant tuberculosis are enrolled from the primary health care clinic. The primary outcome measure is the proportion of culture-confirmed pulmonary tuberculosis cases initiated on appropriate treatment within 30 days of initial clinic visit. Univariate logistic regression will be performed as the primary analysis using generalised estimating equations with a binomial distribution function and a logit link.

Conclusion: diagnostic research tends to focus only on performance of diagnostic tests rather than on patient-important outcomes. This trial has been designed to improve the quality of evidence around diagnostic strategies and to inform the scale-up of new tuberculosis diagnostics within public health systems in high-burden settings

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Published date: 12 June 2013
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 354281
URI: https://eprints.soton.ac.uk/id/eprint/354281
ISSN: 1745-6215
PURE UUID: ceae0da2-e68a-4f90-ad3d-8c74c1732223
ORCID for Nuala McGrath: ORCID iD orcid.org/0000-0002-1039-0159
ORCID for Marie-Louise Newell: ORCID iD orcid.org/0000-0002-1074-7699

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Date deposited: 05 Jul 2013 10:52
Last modified: 20 Jul 2019 00:39

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