4. Discussion
TB
Here, we demonstrated an analytic approach that can provide early proof of concept of the potential costs and health utilities of a proposed randomized control trial demonstrating a mortality benefit to the hypothetical early empiric anti-TB therapy arm regardless of the diagnostic strategy used (urine LAM, sputum Xpert MTB/RIF, or LAM+Xpert). This approach also provided costs estimates and ICER for the time horizon of the clinical trial, which may allow for more precise clinical trial budget estimates [Decision analysis models can help support or refute the underlying hypothesis or treatment modality in question, further refine the budget impact of the trial itself, and differentiate the incremental cost and effect using various diagnostic approaches. Finally, this type of model gave further weight to determining which variables contribute to the overall effectiveness of the intervention, in this case drawing attention to the importance of optimally treating rifampin-susceptible TB. Thus, future strategies should be considered that tailor the composition of the immediate empiric regimen that optimizes rifampin-susceptible TB treatment, such as higher doses of isoniazid and rifampin to overcome potentially suboptimal pharmacokinetics [