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Table 6 Secondary endpoints

From: Impact of systematic early tuberculosis detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries (TB-Speed pneumonia): a stepped wedge cluster randomized trial

Endpoints Measures Time of measurement
Secondary endpoints considered for a comparison between arms
 TB diagnosis based on the clinician’s judgement # of children diagnosed with TB based on the clinician’s judgement Any time during the follow-up
 TB treatment initiation Proportion of children diagnosed with TB AND who with at least one TB treatment recorded Any time during the follow-up
 Time to TB treatment initiation Date/Time of the 1st TB treatment – Date/Time of TB diagnosis (in hours) Any time during the follow-up
 Duration of TB treatment at end of trial Number of days between date of TB treatment initiation and date of TB treatment end Any time during the follow-up (week 12 or early termination)
 Inpatient deaths # of children who died after inclusion and before hospital discharge Before discharge
 Duration of initial hospitalization Date of the 1st recorded discharge – Date of the 1st recorded admission (in days) At the first discharge
 Readmission following discharge # of admission occurring after the 1st discharge Any time during the follow-up
 Weight gain Proportion of weight gain at 12 weeks (as compared to body weight at inclusion) At 12 weeks
 Cost effectiveness Incremental cost-effectiveness ratio (ICER) of intervention compared with WHO SOC, measured in cost per DALY averted Lifetime, based on differences in mortality up to 12 weeks
Secondary endpoints assessed in the intervention group only
 TB detection by NPA testing Proportion of NPA with positive TB detection using Ultra After 1st visit
 TB detection by Stool testing Proportion of stool samples with positive TB detection using Ultra After 1st visit
 TB detection by NPA and Stool testing Proportion of samples (NPA and/or stool) with positive TB detection using Ultra After 1st visit
 Turnaround time between NPA collection and result of Ultra Date/Time of Ultra results – Date/Time of NPA collection After 1st visit
 Turnaround time between stool sample collection and result of Ultra Date/Time of Ultra results – Date/Time of stool sample collection After 1st visit
 NPA collected as per protocol Proportion of children with NPA collected as per protocol At 1st visit
 Stool samples collected as per protocol Proportion of children with stool samples collected as per protocol At 1st visit
 Safety: adverse events (AEs) during NPA collection Number of adverse events collected by study nurses during NPA collection including as vomiting, nose bleeding, low oxygen saturation Any time during the follow-up
 Tolerability: discomfort/pain/distress experienced by the child during NPA collection procedure Assessed by the child him/herself (Wong-Baker face scale), by the parents (visual analog scale), by the nurses (FLACC behavioural scale) At NPA collection time
  1. TB tuberculosis, NPA nasopharyngeal aspirate