Title: Impact of point-of-care Xpert MTB/RIF on tuberculosis treatment initiation: a cluster randomised trial
Authors: Lessells RJ, Cooke GS, McGrath N, Nicol MP, Newell ML, Godfrey-Faussett P.
Journal: Am J Respir Crit Care Med,:doi: 10.1164/rccm.201702-0278OC (2017)
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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Citation: Lessells RJ, Cooke GS, McGrath N, Nicol MP, Newell ML, Godfrey-Faussett P. Impact of point-of-care Xpert MTB/RIF on tuberculosis treatment initiation: a cluster randomised trial Am J Respir Crit Care Med,:doi: 10.1164/rccm.201702-0278OC (2017).