Statistical analysis
tuberculosis
EVENTS, TUBERCULOSIS
The statistical approach is described in the statistical analysis plan included in the appendix (p 84). For the diagnostic effect primary outcome, we assumed that day 8 symptom improvement in trial-of-antibiotics (azithromycin or amoxicillin) groups would correctly classify 60% of all mycobacteriology-negative participants (ie, 60% specificity).All analyses were done using the group to which the participant was randomised. We report measures of effect for comparing azithromycin or amoxicillin groups separately and combined, with the standard of care. We used a generalised linear model with identity-link function to estimate risk differences. Our a priori design did not adjust for multiple comparisons but reported all intervention effects with their 95% CI and p values to facilitate appropriate interpretation.In the pre-specified analysis, we calculated test characteristics (sensitivity and area under the receiver operating characteristic curve) of trial-of-antibiotics versus the sputum mycobacteriological reference standard, and their respective 95% CIs. Post-hoc analyses were also conducted for sensitivity including: (1) all mycobacteriology from day 1, day 8, and day 29; and (2) in participants with tuberculosis clinical diagnoses, defined as initiation of tuberculosis treatment in mycobacteriology-negative patients based on routine clinical or radiological diagnosis, for the reference standard.In our pre-specified subgroup analysis, we examined the diagnostic performance by HIV status. We did not conduct a pre-specified subgroup analysis for the clinical effect primary outcome because of a low number of events. In post-hoc per-protocol analyses for diagnostic and antimicrobial resistance effect, we excluded participants who reported incomplete adherence to treatment (remaining with at least one study tablet by day 8) or taking non-study antibiotics by day 8.