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.
Type
Journal articleSubject
AdultAntitubercular 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
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https://hdl.handle.net/10161/13774Published Version (Please cite this version)
10.1186/1471-2334-14-89Publication Info
(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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Show full item recordScholars@Duke
John Alexander Bartlett
Professor of Medicine
My clinical investigation is focused on the pathogenesis and treatment of HIV infection
and its complications, especially in resource-limited settings. Key Words: HIV infection,
AIDS, treatment strategies, treatment failure, co-infections, resource-limited settings
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
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.
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
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.
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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