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Do high rates of empirical treatment undermine the potential effect of new diagnostic tests for tuberculosis in high-burden settings?

Theron, Grant, Peter, Jonny, Dowdy, David, Langley, Ivor ORCID: https://orcid.org/0000-0002-9275-6731, Squire, Bertie ORCID: https://orcid.org/0000-0001-7173-9038 and Dheda, Keertan (2014) 'Do high rates of empirical treatment undermine the potential effect of new diagnostic tests for tuberculosis in high-burden settings?'. Lancet Infectious Diseases, Vol 14, Issue 6, pp. 527-532.

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Abstract

In tuberculosis-endemic settings, patients are often treated empirically, meaning that they are placed on treatment based on clinical symptoms or tests that do not provide a microbiological diagnosis (eg, chest radiography). New tests for tuberculosis, such as the Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA, USA), are being implemented at substantial cost. To inform policy and rationally drive implementation, data are needed for how these tests affect morbidity, mortality, transmission, and population-level tuberculosis burden. If people diagnosed by use of new diagnostics would have received empirical treatment a few days later anyway, then the incremental benefit might be small. Will new diagnostics substantially improve outcomes and disease burden, or simply displace empirical treatment? Will the extent and accuracy of empirical treatment change with the introduction of a new test? In this Personal View, we review emerging data for how empirical treatment is frequently same-day, and might still be the predominant form of treatment in high-burden settings, even after Xpert implementation; and how Xpert might displace so-called true-positive, rather than false-positive, empirical treatment. We suggest types of studies needed to accurately assess the effect of new tuberculosis tests and the role of empirical treatment in real-world settings. Until such questions can be addressed, and empirical treatment is appropriately characterised, we postulate that the estimated population-level effect of new tests such as Xpert might be substantially overestimated.

Item Type: Article
Subjects: WA Public Health > Preventive Medicine > WA 243 Diagnositic services
WF Respiratory System > Tuberculosis > WF 205 Epidemiology
WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1016/S1473-3099(13)70360-8
Depositing User: Helen Rigby
Date Deposited: 02 May 2014 09:54
Last Modified: 01 Mar 2018 11:09
URI: http://archive.lstmed.ac.uk/id/eprint/3567

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