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 W.; Langley, Ivor; Squire, S. Bertel; Dheda, Keertan

doi:10.1016/s1473-3099(13)70360-8

Cited by 139 publications

(140 citation statements)

References 28 publications

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“…Despite GeneXpert implementation, initiation of TB treatment was disproportionately based on empiric treatment (61%), a process of diagnosing TB based on clinical suspicion and radiological findings and without bacteriological confirmation. 17 Our findings are similar to other studies in South Africa and Uganda that also reported this paradoxical phenomenon of high utilization of empiric treatment in the GeneXpert era. 16,18,19 Notably, even in settings with extensive diagnostics, TB can be missed.…”

Section: Empiric Treatmentsupporting

confidence: 91%

“…First, our observed rate was congruent with TB mortality rates in other high-HIV prevalence settings (18-27%). 17,26,27 GeneXpert testing is expected to affect a decrease in mortality, presumably due to earlier diagnosis, thus earlier treatment. However, in hospital settings, TB disease may be sufficiently advanced that adverse outcomes are difficult to modify.…”

Section: Mortalitymentioning

confidence: 99%

“…The high in-hospital mortality rate confirms the need intensified case finding with GeneXpert further upstream, at the patient's first encounter with the healthcare system, in contrast to our referral medical facility. 17 Multiple healthcare environment factors and patient characteristics are important to consider and target in order to reduce mortality among patients with TB.…”

Section: Mortalitymentioning

confidence: 99%

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Policy to practice: impact of GeneXpert MTB/RIF implementation on the TB spectrum of care in Lilongwe, Malawi

Chawla¹,

Kanyama²,

Mbewe³

et al. 2016

Trans R Soc Trop Med Hyg

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Background: While previous research has provided evidence of the diagnostic accuracy of the GeneXpert MTB/ RIF (GeneXpert), further information is needed about implementation in the real-world. This study evaluated the impact of the introduction of GeneXpert testing in a tertiary medical center according to the testing algorithm proposed by the National TB Control Program (NTP) guidelines.Methods: All adult medical inpatient persons with presumptive TB admitted between November 2013 and March 2014 were eligible for GeneXpert sputum testing and followed to TB treatment initiation status.Results: We identified 932 persons with presumptive TB, of which 307 (32.9%) were GeneXpert tested. Those tested had an average age of 40 years, 49.2% (151) were male, 34.5% (106) were HIV positive, and 84.1% (249) presented with a cough. Of those GeneXpert tested, 28/307 (9.1%) tested positive, a 55.5% increase in detection compared to smear microscopy. However, the majority (44/72, 61%) of TB diagnoses were made by other modalities and not confirmed microbiologically. Of the 58 patients recommended to start treatment and discharged from the hospital, only 23 (40%) were documented to have started treatment at regional directly observed treatment, short course (DOTS) centers.Conclusions: GeneXpert contributed minimally to overall TB diagnosis and the cascade of care due to implementation challenges of sputum collection, empiric treatment, and weak linkage to care between inpatient and outpatient settings.

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Section: Empiric Treatmentsupporting

confidence: 91%

Section: Mortalitymentioning

confidence: 99%

Section: Mortalitymentioning

confidence: 99%

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Policy to practice: impact of GeneXpert MTB/RIF implementation on the TB spectrum of care in Lilongwe, Malawi

Chawla¹,

Kanyama²,

Mbewe³

et al. 2016

Trans R Soc Trop Med Hyg

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“…Studies [8][9][10][11] in different settings have found little or no change in the number of pulmonary TB diagnoses or deaths when comparing sputum smear microscopy and Xpert MTB/RIF, a more sensitive molecular test 12 . This result may reflect high levels of empirical treatment among people who test negative [13][14][15] . Against this backdrop, a key question remains: if novel diagnostic tests are developed and implemented at scale, what impact can we expect on TB epidemiology within populations?…”

mentioning

confidence: 99%

Understanding the incremental value of novel diagnostic tests for tuberculosis

Arinaminpathy

Dowdy

2015

Nature

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109

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Tuberculosis is a major source of global mortality caused by infection, partly because of a tremendous ongoing burden of undiagnosed disease. Improved diagnostic technology may play an increasingly crucial part in global efforts to end tuberculosis, but the ability of diagnostic tests to curb tuberculosis transmission is dependent on multiple factors, including the time taken by a patient to seek health care, the patient's symptoms, and the patterns of transmission before diagnosis. Novel diagnostic assays for tuberculosis have conventionally been evaluated on the basis of characteristics such as sensitivity and specificity, using assumptions that probably overestimate the impact of diagnostic tests on transmission. We argue for a shift in focus to the evaluation of such tests' incremental value, defining outcomes that reflect each test's purpose (for example, transmissions averted) and comparing systems with the test against those without, in terms of those outcomes. Incremental value can also be measured in units of outcome per incremental unit of resource (for example, money or human capacity). Using a novel, simplified model of tuberculosis transmission that addresses some of the limitations of earlier tuberculosis diagnostic models, we demonstrate that the incremental value of any novel test depends not just on its accuracy, but also on elements such as patient behaviour, tuberculosis natural history and health systems. By integrating these factors into a single unified framework, we advance an approach to the evaluation of new diagnostic tests for tuberculosis that considers the incremental value at the population level and demonstrates how additional data could inform more-effective implementation of tuberculosis diagnostic tests under various conditions

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“…The TB-NEAT trial 26 found that Xpert did not affect mortality and could replace, but not reduce, empirical treatment. The absence of the anticipated reduction in empirical treatment might have been partly attributable to providers becoming more aware of the limitations of tuberculosis diagnostics generally.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of Xpert MTB/RIF for tuberculosis diagnosis in South Africa: A real-world cost analysis and economic evaluation

2017

Indian Journal of Tuberculosis

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

Cited by 139 publications

References 28 publications

Policy to practice: impact of GeneXpert MTB/RIF implementation on the TB spectrum of care in Lilongwe, Malawi

Policy to practice: impact of GeneXpert MTB/RIF implementation on the TB spectrum of care in Lilongwe, Malawi

Understanding the incremental value of novel diagnostic tests for tuberculosis

Cost-effectiveness of Xpert MTB/RIF for tuberculosis diagnosis in South Africa: A real-world cost analysis and economic evaluation

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