Table 2 Summary of methods of data collection and analysis for primary and secondary outcomes
Variable | Method of data collection | Method of data analysis |
|---|---|---|
Primary outcome: TB treatment outcome as defined by WHO and the South Africa TB Management Guidelines (see Table 1) | • CRF and TB treatment record • Treatment outcome as recorded by TB nurses in TB cards using the standard WHO definitions of cure, completions, failure, death, TB treatment interruption, drug resistance developed in course of treatment (confirmed for correctness by checking sputum culture/smear at baseline, at 5 and 6 months) | Binary outcome: successful (cured of completed) vs not successful (died, failure, treatment interruption, drug-resistant TB) All participants, excluding those transferred out |
Secondary outcome: sputum conversion | • Sputum culture/smear at baseline, 5 and 6 months to determine cure rates for PTB patients who had a positive smear or culture at baseline • Sputum conversion at 2–3 months | Binary cured vs not cured for the subgroups of participants who had a positive smear/culture at baseline Binary conversion vs not for the subgroups of participants who had a positive smear/culture at baseline |
Secondary outcome: change in smoking behaviour | • CRF – questions as per Russell’s Standard – baseline smoking behaviours and then at 3 and 6 months • Exhaled carbon monoxide reading at 3  and 6 months | Binary outcome validated 3 and 6 months sustained smoking cessation for the subgroup of participants who were smoking at baseline |
Secondary outcome: percentage reduction in harmful or hazardous drinking (change in AUDIT score) | • AUDIT score at baseline and at 3 and 6 months | Change in AUDIT score (continuous) for subgroups of participants who were hazardous or harmful drinkers at baseline |
Secondary outcome: HIV and TB medication adherence | • CRF – questions modified from ACTG | Binary outcome (% adherent vs non-adherent) |
Secondary outcome: proportion of HIV-positive participants on ART | • HIV status at baseline • ART status at baseline, 3 months and 6 months | Binary on ART vs not on ART for the subgroup of HIV-positive participants, taking into account baseline % on ART |