Table 2 EMPIRICAL endpoints and outcomes
Variable/outcome | Hypothesis | Outcome measure | Method of analysis |
|---|---|---|---|
Primary | Intervention improves survival at 15d and 1y | All-cause Mortality rate | Generalized Linear Mixed Models |
Mortality (rate incidence/person) | Event mortality | Generalized Linear Mixed Models (Logistic) | |
Mortality (dichotomous) | Time-to-event | Flexible splines survival analysis and Kaplan Meier | |
Secondary | |||
Serious adverse events | Non-superiority of treatment arms | Event rate (density incidence person-year) | Chi-squared/Fisher-test Generalized Linear Mixed Models (Poisson) Kaplan-Meier |
Serious adverse reactions | Non-superiority of treatment arms | ||
Unexpected Serious Adverse reactions | Non-superiority of treatment arms | ||
Withdrawal treatment due to AEs | Occurrence | Proportions of withdrawals of treatment | Chi-squared/ Fisher-test |
Cumulative days of hospitalization | Improvement with treatment arms | Days of hospitalization | T-test/Kruskal-test |
Duration of oxygen requirements | Improvement with treatment arms | Days with oxygen therapy | T-test/Kruskal-test |
Incidence of TB-related immune-reconstitution inflammatory syndrome (IRIS) | Occurrence | Proportions of IRIS cases | Chi-squared/ Fisher-test |
CMV prevalence | At least 60% of participants | Proportion of participants with PCR+ in saliva | Chi-squared/ Fisher-test |
TB prevalence | At least 15% of participants | Proportion of participants with TB test + | Chi-squared/ Fisher-test |
TB incidence | Improvement with treatment arms | Proportion of participants with TB | Chi-squared/ Fisher-test |
CMV viral load reduction at 15 days | Improvement with treatment arms | Change in qualitative CMV viral load in urine | Chi-squared/ Fisher-test |
TB-LAM accuracy | TB-LAM improve TB diagnosis accuracy compare to GeneXpert Ultra in feces and nasopharyngeal aspirate (NPA). | Sensitivity and specificity of both diagnostic techniques | AUC curves and Kappa Index |
Death due to TB | Improvement with TB-T | TB death according to the cause of death test | Chi-squared/ Fisher-test |
Death due to CMV | Improvement with CMV | CMV death according to the cause of death test | Chi-squared/ Fisher-test |
Quality-adjusted life expectancy | Quality-adjusted life expectancy improvement with treatment arms | Quality-adjusted life expectancy | Chi-squared/ Fisher-test |
Per-patient cost | Inferiority with treatment arms | Per-patient cost | T-test/Kruskal-test |