Table 2 Secondary outcomes of the TB SCRIPT trial
Outcome | Numerator | Denominator |
|---|---|---|
A. TB incidence | ||
Number diagnosed with microbiologically confirmed incident TB within 2 years | # diagnosed with incident TB (incident TB = positive non-trace Xpert Ultra result, two trace Xpert Ultra results, or ≥ 1 positive culture result > 3 months after study entry) | None |
2-year incidence of microbiologically confirmed TB | # diagnosed with incident TB | # randomized to corresponding study arm - # treated for prevalent TB (prevalent TB = active TB diagnosed ≤3 months of study entry) |
Time to microbiologically confirmed incident TB diagnosis | Days from 3 months post-enrollment to incident TB diagnosis (or censoring) | |
Incident rate of microbiologically confirmed TB | # diagnosed with incident TB | (# randomized to corresponding study arm - # treated for prevalent TB)/time in person-years |
Number diagnosed with drug-resistant incident TB within 2 years | # diagnosed with incident drug-resistant TB (drug-resistant TB = DST-detected resistance to drugs administered for TPT [e.g., isoniazid]) | None |
2-year incidence of drug-resistant TB among people receiving TPT | # diagnosed with incident drug-resistant TB | # received TPT of any duration |
B. Mortality | ||
Number who died from any cause within 2 years | # deaths from any cause | None |
2-year all-cause mortality | # deaths from any cause | # randomized to corresponding study arm |
Time to death from any cause | Days from enrollment to death from any cause | |
All-cause mortality rate | # deaths from any cause | # randomized to corresponding study arm/time in person-years |
Number who died from TB within 2 years | # deaths from confirmed TB + # deaths from probable TB (probable TB = review of medical records suggests TB strongly suspected) | None |
2-year TB-specific mortality | # deaths from confirmed TB + # deaths from probable TB | # randomized to corresponding study arm |
C. TPT uptake | ||
Number screen-negatives prescribed TPT | # screen-negatives prescribed TPT (baseline screen-negatives prescribed TPT ~ study staff-prescribed TPT) | None |
Proportion screen-negatives prescribed TPT | # screen-negatives prescribed TPT | # randomized to corresponding study arm |
Number screen-positives prescribed TPT | # screen-positives prescribed TPT (baseline screen-positives prescribed TPT ~ routine clinician-prescribed TPT) | None |
Proportion screen-positives prescribed TPT | # screen-positives prescribed TPT | # randomized to corresponding study arm |
Number initiated on TPT | # screen-negatives prescribed TPT + # screen-positives prescribed TPT | None |
Proportion initiated on TPT | # screen-negatives prescribed TPT + # screen-positives prescribed TPT | # randomized to corresponding study arm |
Time to TPT initiation | Days from baseline TB screening to initiation of TPT | |
Number completing TPT (measured by pill count, self-reported adherence) | # initiated on TPT who completed ≥90% of treatment over prescribed TPT period | None |
Proportion completing TPT (measured by pill count, self-reported adherence) | # initiated on TPT who completed ≥90% of treatment over prescribed TPT period | # randomized to corresponding study arm |
D. Prevalent TB diagnosis | ||
Number microbiologically confirmed prevalent TB cases detected by the screening test | # screen-positives diagnosed with prevalent TB (diagnosed = a positive urine LAM result, one non-trace positive or two trace-positive Xpert Ultra results ≤3 months of study entry) | |
Proportion microbiologically confirmed prevalent TB cases detected by the screening test | # screen-positives diagnosed with prevalent TB | # randomized to corresponding study arm |
Number microbiologically confirmed prevalent TB cases missed by the screening test | # screen-negatives diagnosed with prevalent TB | None |
Proportion microbiologically confirmed prevalent TB cases missed by the screening test | # screen-negatives diagnosed with prevalent TB | # randomized to corresponding study arm |
Number diagnosed with microbiologically confirmed prevalent TB | # screen-positives diagnosed with prevalent TB + # screen-negatives diagnosed with prevalent TB | None |
Microbiologically confirmed TB prevalence | # screen-positives diagnosed with prevalent TB + # screen-negatives diagnosed with prevalent TB | # randomized to corresponding study arm |
E. Prevalent TB treatment | ||
Number treated for prevalent TB | # treated (treated = initiated on TB treatment ≤3 months of study entry regardless of Xpert Ultra result) | None |
Proportion treated for prevalent TB | # treated | # randomized to corresponding study arm |
Number with microbiologically confirmed prevalent TB completing treatment | # diagnosed AND treated who complete treatment (complete treatment = clinic TB treatment records confirm treatment completion) | None |
Proportion with microbiologically confirmed prevalent TB completing treatment | # diagnosed AND treated who complete treatment | # diagnosed |
Time to treatment of microbiologically confirmed prevalent TB | Days from prevalent TB diagnosis to initiation of TB treatment | |