Preprint, 2024
Factors associated with tuberculosis treatment initiation among bacteriologically negative individuals evaluated for tuberculosis: an individual patient data meta-analysis
medRxiv,
Volume 5,
04-19,
Page 2024.04.07.24305445,
10.1101/2024.04.07.24305445
Contributors
Kim, Sun
(Corresponding author)
[1]
Can, Melike Hazal
[1]
Agizew, Tefera Belachew
0000-0003-1848-7307
[2]
Auld, Andrew F
[3]
Balcells, María Elvira
0000-0002-7223-9665
[4]
Bjerrum, Stephanie
0000-0002-9046-6255
[5]
[6]
Dheda, Keertan Unkha
0000-0001-7709-5341
[7]
[8]
Dorman, Susan E
[9]
Esmail, Aliasgar
[8]
Fielding, Katherine
[7]
García-Basteiro, Alberto L
0000-0002-2038-5505
[10]
[11]
[12]
Hanrahan, Colleen F
0000-0002-4544-4591
[13]
Kebede, Wakjira
[14]
Kohli, Mikashmi
0000-0002-7402-5791
[15]
Luetkemeyer, Anne F.
[16]
Mita, Carol
[1]
Reeve, Byron W P
0000-0002-3332-3477
[17]
Silva, Denise Rossato
0000-0003-0230-2734
[18]
Sweeney, Sedona
[7]
Theron, Grant De Vos
0000-0002-9216-2415
[17]
Trajman, Anete
0000-0002-4000-4984
[19]
[20]
Vassall, Anna
0000-0002-2911-1375
[7]
Warren, Joshua L.
[21]
Yotebieng, Marcel
0000-0003-2110-2631
[22]
Cohen, Ted
[21]
Menzies, Nicolas A
0000-0002-2571-016X
[1]
Affiliations
- [1]
Harvard University
[NORA names:
United States; America, North; OECD];
- [2]
U.S. Centers for Disease Control and Prevention, Botswana
[NORA names:
Botswana; Africa];
- [3]
U.S. Centers for Disease Control and Prevention, Lusaka, Zambia
[NORA names:
Zambia; Africa];
- [4]
Pontificia Universidad Católica de Chile
[NORA names:
Chile; America, South; OECD];
- [5]
Rigshospitalet
[NORA names:
Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
(... more)
- [6]
University of Southern Denmark
[NORA names:
SDU University of Southern Denmark;
University; Denmark; Europe, EU; Nordic; OECD];
- [7]
London School of Hygiene & Tropical Medicine
[NORA names:
United Kingdom; Europe, Non-EU; OECD];
- [8]
University of Cape Town
[NORA names:
South Africa; Africa];
- [9]
Medical University of South Carolina
[NORA names:
United States; America, North; OECD];
- [10]
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Barcelona, Spain
[NORA names:
Spain; Europe, EU; OECD];
- [11]
Hospital Clínic de Barcelona
[NORA names:
Spain; Europe, EU; OECD];
- [12]
Manhiça Health Research Centre
[NORA names:
Mozambique; Africa];
- [13]
Johns Hopkins University
[NORA names:
United States; America, North; OECD];
- [14]
Jimma University
[NORA names:
Ethiopia; Africa];
- [15]
Foundation for Innovative New Diagnostics
[NORA names:
Switzerland; Europe, Non-EU; OECD];
- [16]
University of California, San Francisco
[NORA names:
United States; America, North; OECD];
- [17]
Stellenbosch University
[NORA names:
South Africa; Africa];
- [18]
Federal University of Rio Grande do Sul
[NORA names:
Brazil; America, South];
- [19]
Federal University of Rio de Janeiro
[NORA names:
Brazil; America, South];
- [20]
McGill University
[NORA names:
Canada; America, North; OECD];
- [21]
Yale University
[NORA names:
United States; America, North; OECD];
- [22]
Albert Einstein College of Medicine
[NORA names:
United States; America, North; OECD]
(less)
Abstract
Background: Globally, over one-third of pulmonary tuberculosis (TB) disease diagnoses are made based on clinical criteria after a negative diagnostic test result. Understanding factors associated with clinicians' decisions to initiate treatment for individuals with negative test results is critical for predicting the potential impact of new diagnostics.
Methods: We performed a systematic review and individual patient data meta-analysis using studies conducted between January/2010 and December/2022 (PROSPERO: CRD42022287613). We included trials or cohort studies that enrolled individuals evaluated for TB in routine settings. In these studies participants were evaluated based on clinical examination and routinely-used diagnostics, and were followed for ≥1 week after the initial test result. We used hierarchical Bayesian logistic regression to identify factors associated with treatment initiation following a negative result on an initial bacteriological test (e.g., sputum smear microscopy, Xpert MTB/RIF).
Findings: Multiple factors were positively associated with treatment initiation: male sex [adjusted Odds Ratio (aOR) 1.61 (1.31-1.95)], history of prior TB [aOR 1.36 (1.06-1.73)], reported cough [aOR 4.62 (3.42-6.27)], reported night sweats [aOR 1.50 (1.21-1.90)], and having HIV infection but not on ART [aOR 1.68 (1.23-2.32)]. Treatment initiation was substantially less likely for individuals testing negative with Xpert [aOR 0.77 (0.62-0.96)] compared to smear microscopy and declined in more recent years.
Interpretation: Multiple factors influenced decisions to initiate TB treatment despite negative test results. Clinicians were substantially less likely to treat in the absence of a positive test result when using more sensitive, PCR-based diagnostics.
Keywords
Bayesian logistic regression,
HIV,
HIV infection,
Multiple factors influence decisions,
PCR-based diagnostics,
TB treatment,
Understanding factors,
Xpert,
absence,
art,
associated with treatment initiation,
bacteriological tests,
bacteriology,
clinical criteria,
clinical examination,
clinicians,
clinicians' decisions,
cohort,
cohort study,
cough,
criteria,
data meta-analysis,
decision,
diagnosis,
diagnostic test results,
diagnostics,
disease,
disease diagnosis,
examination,
factors,
factors associated with treatment initiation,
factors influence decisions,
hierarchical Bayesian logistic regression,
history,
impact,
individual patient data meta-analysis,
individuals,
infection,
initial treatment,
initiation,
logistic regression,
male sex,
meta-analysis,
microscopy,
multiple factors,
negative diagnostic test result,
negative individuals,
negative results,
negative test results,
night,
night sweats,
participants,
patient data meta-analysis,
positive test results,
potential impact,
pulmonary tuberculosis,
regression,
report cough,
results,
review,
sex,
smear microscopy,
study,
study participants,
sweat,
systematic review,
test,
test results,
treatment,
treatment initiation,
trials,
tuberculosis,
tuberculosis treatment initiation,
weeks,
years
Funders
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