A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania.

Abstract

BACKGROUND: Routine tuberculosis culture remains unavailable in many high-burden areas, including Tanzania. This study sought to determine the impact of providing mycobacterial culture results over standard of care [unconcentrated acid-fast (AFB) smears] on management of persons with suspected tuberculosis. METHODS: Adults and children with suspected tuberculosis were randomized to standard (direct AFB smear only) or intensified (concentrated AFB smear and tuberculosis culture) diagnostics and followed for 8 weeks. The primary endpoint was appropriate treatment (i.e. antituberculosis therapy for those with tuberculosis, no antituberculous therapy for those without tuberculosis). RESULTS: Seventy participants were randomized to standard (n = 37, 53%) or intensive (n = 33, 47%) diagnostics. At 8 weeks, 100% (n = 22) of participants in follow up randomized to intensive diagnostics were receiving appropriate care, vs. 22 (88%) of 25 participants randomized to standard diagnostics (p = 0.14). Overall, 18 (26%) participants died; antituberculosis therapy was associated with lower mortality (9% who received antiuberculosis treatment died vs. 26% who did not, p = 0.04). CONCLUSIONS: Under field conditions in a high burden setting, the impact of intensified diagnostics was blunted by high early mortality. Enhanced availability of rapid diagnostics must be linked to earlier access to care for outcomes to improve.

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Published Version (Please cite this version)

10.1186/1471-2334-14-89

Publication Info

Reddy, Elizabeth A, Boniface N Njau, Susan C Morpeth, Kathryn E Lancaster, Alison C Tribble, Venance P Maro, Levina J Msuya, Anne B Morrissey, et al. (2014). A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania. BMC Infect Dis, 14. p. 89. 10.1186/1471-2334-14-89 Retrieved from https://hdl.handle.net/10161/13774.

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Scholars@Duke

Thielman

Nathan Maclyn Thielman

Professor of Medicine

Broadly, my research focuses on a range of clinical and social issues that affect persons living with or at risk for HIV infection in resource-poor settings. In Tanzania, our group is applying novel methods to optimize HIV testing uptake among high-risk groups. We recently demonstrated that the Discrete Choice Experiment (DCE), a form of stated preference survey research, is a robust tool for identifying (a) which characteristics of HIV testing options are most preferred by different populations and (b) which tradeoffs individuals make in evaluating testing options. Building on more than a decade of productive HIV testing research in the Kilimanjaro Region, the next phase of our NIMH funded project will test the hypothesis that DCE-derived HIV testing options significantly increases rates of testing among groups at high risk for HIV infection. This work holds promise not only for optimizing HIV testing uptake in the Kilimanjaro Region, but also for applying novel tools in the service of translational epidemiology and implementation research.

Chow

Shein-Chung Chow

Professor of Biostatistics & Bioinformatics

My research interest includes statistical methodology development and application in the area of biopharmaceutical/clinical statistics such as bioavailability and bioequivalence, clinical trials, bridging studies, medical devices, and translational research/medicine. Most recently, I am interested in statistical methodology development for the use of adaptive design methods in clinical trials and methodology development for assessment of biosimilarity of follow-on biologics. In addition, I am also interested in methodology development for statistical evaluation of traditional Chinese medicine (TCM) clinical trials.

Stout

Jason Eric Stout

Professor of Medicine

My research focuses on the epidemiology, natural history, and treatment of tuberculosis and nontuberculous mycobacterial infections. I am also interested in the impact of HIV infection on mycobacterial infection and disease, and in examining health disparities as they relate to infectious diseases, particularly in immigrant populations.


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