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

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Date
2014-02-20
Authors
Reddy, Elizabeth A
Njau, Boniface N
Morpeth, Susan C
Lancaster, Kathryn E
Tribble, Alison C
Maro, Venance P
Msuya, Levina J
Morrissey, Anne B
Kibiki, Gibson S
Thielman, Nathan M
Cunningham, Coleen K
Schimana, Werner
Shao, John F
Chow, Shein-Chung
Stout, Jason E
Crump, John A
Bartlett, John A
Hamilton, Carol D
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(18 total)
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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.
Type
Journal article
Subject
Adult
Antitubercular Agents
Bacteriological Techniques
Child, Preschool
Decision Making
Diagnostic Tests, Routine
Female
HIV Infections
Humans
Infant
Male
Middle Aged
Mycobacterium tuberculosis
Standard of Care
Tanzania
Treatment Outcome
Tuberculosis
Tuberculosis, Pulmonary
Permalink
https://hdl.handle.net/10161/13774
Published Version (Please cite this version)
10.1186/1471-2334-14-89
Publication Info
Reddy, Elizabeth A; Njau, Boniface N; Morpeth, Susan C; Lancaster, Kathryn E; Tribble, Alison C; Maro, Venance P; ... Hamilton, Carol D (2014). A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania. BMC Infect Dis, 14. pp. 89. 10.1186/1471-2334-14-89. Retrieved from https://hdl.handle.net/10161/13774.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Bartlett

John Alexander Bartlett

Professor of Medicine
My clinical investigation is focused on the pathogenesis and treatment of HIV infection and its complicastions, especially in resource-limited settings. Key Words: HIV infection, AIDS, treatment strategies, treatment failure, co-infections, resource-limited settings
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

John Andrew Crump

Adjunct Professor in the Department of Medicine
I am based in northern Tanzania where I am Site Leader for Duke University’s collaborative research program based at Kilimanjaro Christian Medical Centre and Director of Tanzania Operations for the Duke Global Health Institute. I oversee the design and implementation of research studies on infectious diseases, particularly febrile illness, invasive bacterial disease, HIV-associated opportunistic infections, clinical trials of antiretroviral therapy and prevention of mother-to-child tr
Cunningham

Coleen Kathryn Cunningham

Adjunct Professor in the Department of Pediatrics
Dr. Cunningham is a pediatric infectious diseases physician who has focused her research on the prevention and treatment of HIV infection in children.  She has also played important roles in evaluation of vaccines for other infectious diseases and recently has worked on Ebola virus treatment studies.  She is currently working on studies of active and passive immunization to prevent HIV transmission in neonates born to HIV infected women.
Hamilton

Carol Dukes Hamilton

Professor Emeritus of Medicine
Carol Dukes Hamilton, MD, MHS is a Professor of Medicine, Emeritus, in the Infectious Diseases Division, Department of Medicine, Duke University Medical Center.  She has nearly 40 years of experience spanning clinical care, research, public health, and global leadership. She served as clinician and full-time faculty at Duke University Medical Center from 1991 until 2008, concentrating on outpatient and inpatient clinical care (HIV/AIDS, tuberculosis [TB], and routine infectious disease prob
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.
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 populati
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