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Impact of point-of-care Xpert MTB/RIF on tuberculosis treatment initiation: a cluster randomised trial

Impact of point-of-care Xpert MTB/RIF on tuberculosis treatment initiation: a cluster randomised trial
Impact of point-of-care Xpert MTB/RIF on tuberculosis treatment initiation: a cluster randomised trial

Rationale: Point-of-care (POC) diagnostics have potential to reduce pre-treatment loss to follow-up and delays to initiation of appropriate TB treatment.

Objective: To evaluate the effect of a POC diagnostic strategy on initiation of appropriate TB treatment.

Methods: A cluster randomised trial of adults with cough who were HIV positive and/or at high risk of drug-resistant TB. Two-week time blocks were randomised to two strategies (i) Xpert performed at district hospital laboratory (ii) POC Xpert performed at primary health care clinic. All participants provided two sputum specimens: one for Xpert and the other for culture as reference standard. The primary outcome was the proportion of culture-positive pulmonary TB (PTB) cases initiated on appropriate TB treatment within 30 days.

Measurements and Main Results: Between August 22, 2011 and March 1, 2013, 36 two-week blocks were randomised and 1297 individuals were enrolled (646 in the laboratory arm, 651 in the POC arm); 159 (12.4%) had culture-positive PTB. The proportion of culture-positive PTB cases initiated on appropriate TB treatment within 30 days was 76.5% in the laboratory arm and 79·5% in the POC arm (odds ratio 1·13, 95% confidence interval [CI] 0·51-2.53, p = 0·76; risk difference 3.1%, 95% CI -16.2, 10.1). The median time to initiation of appropriate treatment was 7 days (laboratory) vs. 1 day (POC).

Conclusions: POC positioning of Xpert led to more rapid initiation of appropriate TB treatment. Achieving one-stop diagnosis and treatment for all people with TB will require simpler, more sensitive diagnostics and broader strengthening of health systems.

1073-449X
Lessells, Richard J.
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Cooke, Graham S.
805ef7af-ed75-492b-b484-aa0b3b24ed8e
Mcgrath, Nuala
b75c0232-24ec-443f-93a9-69e9e12dc961
Nicol, Mark P.
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Newell, Marie-Louise
c6ff99dd-c23b-4fef-a846-a221fe2522b3
Godfrey-Faussett, Peter
5c1047a6-ac3f-45ed-81c8-4549cd652caa
Lessells, Richard J.
a1f066e7-ad3c-4050-b91f-91193e19f9df
Cooke, Graham S.
805ef7af-ed75-492b-b484-aa0b3b24ed8e
Mcgrath, Nuala
b75c0232-24ec-443f-93a9-69e9e12dc961
Nicol, Mark P.
97abfb6e-5d98-466a-af96-4a4c9ccfd570
Newell, Marie-Louise
c6ff99dd-c23b-4fef-a846-a221fe2522b3
Godfrey-Faussett, Peter
5c1047a6-ac3f-45ed-81c8-4549cd652caa

Lessells, Richard J., Cooke, Graham S., Mcgrath, Nuala, Nicol, Mark P., Newell, Marie-Louise and Godfrey-Faussett, Peter (2017) Impact of point-of-care Xpert MTB/RIF on tuberculosis treatment initiation: a cluster randomised trial. American Journal of Respiratory and Critical Care Medicine. (doi:10.1164/rccm.201702-0278OC).

Record type: Article

Abstract

Rationale: Point-of-care (POC) diagnostics have potential to reduce pre-treatment loss to follow-up and delays to initiation of appropriate TB treatment.

Objective: To evaluate the effect of a POC diagnostic strategy on initiation of appropriate TB treatment.

Methods: A cluster randomised trial of adults with cough who were HIV positive and/or at high risk of drug-resistant TB. Two-week time blocks were randomised to two strategies (i) Xpert performed at district hospital laboratory (ii) POC Xpert performed at primary health care clinic. All participants provided two sputum specimens: one for Xpert and the other for culture as reference standard. The primary outcome was the proportion of culture-positive pulmonary TB (PTB) cases initiated on appropriate TB treatment within 30 days.

Measurements and Main Results: Between August 22, 2011 and March 1, 2013, 36 two-week blocks were randomised and 1297 individuals were enrolled (646 in the laboratory arm, 651 in the POC arm); 159 (12.4%) had culture-positive PTB. The proportion of culture-positive PTB cases initiated on appropriate TB treatment within 30 days was 76.5% in the laboratory arm and 79·5% in the POC arm (odds ratio 1·13, 95% confidence interval [CI] 0·51-2.53, p = 0·76; risk difference 3.1%, 95% CI -16.2, 10.1). The median time to initiation of appropriate treatment was 7 days (laboratory) vs. 1 day (POC).

Conclusions: POC positioning of Xpert led to more rapid initiation of appropriate TB treatment. Achieving one-stop diagnosis and treatment for all people with TB will require simpler, more sensitive diagnostics and broader strengthening of health systems.

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Accepted/In Press date: 20 July 2017
e-pub ahead of print date: 20 July 2017
Published date: October 2017

Identifiers

Local EPrints ID: 412686
URI: http://eprints.soton.ac.uk/id/eprint/412686
ISSN: 1073-449X
PURE UUID: 9ed0320c-02af-45a7-b0ee-fffe42086d2b
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: 26 Jul 2017 16:30
Last modified: 16 Mar 2024 05:34

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Contributors

Author: Richard J. Lessells
Author: Graham S. Cooke
Author: Nuala Mcgrath ORCID iD
Author: Mark P. Nicol
Author: Peter Godfrey-Faussett

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