• Sun Kim, Melike Hazal Can, Tefera B Agizew, Andrew F Auld, Maria Elvira Balcells, Stephanie Bjerrum, Keertan Dheda, Susan E Dorman, Aliasgar Esmail, Katherine Fielding, Alberto L Garcia-Basteiro, Colleen F Hanrahan, Wakjira Kebede, Mikashmi Kohli, Anne F Luetkemeyer, Carol Mita, Byron W P Reeve, Denise Rossato Silva, Sedona Sweeney, Grant Theron, Anete Trajman, Anna Vassall, Joshua L Warren, Marcel Yotebieng, Ted Cohen, and Nicolas A Menzies.
• Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.
• PLoS Med. 2025 Jan 1; 22 (1): e1004502e1004502.

BackgroundGlobally, over one-third of pulmonary tuberculosis (TB) disease diagnoses are made based on clinical criteria after a negative bacteriological test result. There is limited information on the factors that determine clinicians' decisions to initiate TB treatment when initial bacteriological test results are negative.Methods And FindingsWe 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 (SSM), Xpert MTB/RIF). 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. We were not able assess why clinicians made treatment decisions, as these data were not available.ConclusionsMultiple 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.Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.

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