Bor 2012.
Methods | CBA study (retrospective) | |
Participants | 32,321 population cohort of all working‐age (18‐59) people who were members of a household in Africa Centre for Health and Population Studies’s population surveillance area during the 10‐year follow‐up period, excluding HIV+ persons not accessing ART. (South Africa) Index group: 2027 HIV+ persons Reference group: 30,294 |
|
Interventions | Intervention: Pharmacological, ART through the Hlabisa HIV Treatment and Care Program Control: Drawn from the same population, but non‐HIV, untreated, apparently healthy |
|
Outcomes | Employment: Employment status measured as 'yes' or 'no' Authors also assessed: 1) Unemployment due to illness, 2) Residence in surveillance area (migration indicator), 3) Physical function: Walk 5 km without stopping, carry heavy objects for 20 meters without stopping, participate in vigorous activities, 4) Immunological status: CD4+ lymphocyte counts |
|
Notes | ART | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
14. Blinding (Subjects) | Low risk | Retrospective data collected and cross‐referenced from a cohort's surveys of sociodemographics and health data. Participants were unaware they were under investigation for the specific intervention at the time of the cohort surveys. |
15. Blinding (outcome assessors) | Low risk | Not blinded. Retrospective data collected and cross‐referenced from a cohort's surveys of sociodemographics and health data. Objective outcomes that should have been unaffected by blinding. |
16. Retrospective unplanned subgroup analysis | Unclear risk | Retrospective study, data dredging not clear. |
17. Follow‐up | Low risk | Follow‐ups conducted for both index and reference at 8‐5 years, 5‐3 years, 3‐2.5 years, 2.5‐2 years, 2‐1.5 years, 1.5‐1 years, 1‐0.5 year both pre‐ and post‐ART initiation. |
18. Statistical tests | Low risk | Odds ratio, t‐statistics, and hazards ratio |
19. Compliance | Unclear risk | Compliance to ART was not monitored or insured. ART adherence is required for survival, therefore compliance is highly likely. |
20. Outcome measures | Low risk | All predetermined outcome measures were analyzed and reported. |
21. Selection Bias (population) | Low risk | All participants were collected from South Africa's Africa Centre population surveillance area in the Hlabisa subdistrict. The study used all HIV+ persons who were utilizing ART during the 10‐year follow‐up period of the Africa Centre's population surveillance study. |
22. Selection bias (time) | Low risk | All individuals residing in the surveillance area were monitored between 2001‐2010 and for inclusion in the study were required to have lived in the surveillance area 6 months prior to the establishment of the Hlabisa HIV Treatment and Care Program. |
23. Randomization | High risk | No randomization. Retrospective cohort study. |
24. Allocation concealment | Unclear risk | Retrospective study of a cohort. Participants were not assigned by the research team, but were predetermined by health status. Did not report the use of adequate sequence generation or allocation concealment techniques. |
25. Adjustment for confounding | High risk | Migration confounder addressed. Gender differences not addressed. Age differences not addressed. SES differences not addressed. Disease severity not addressed. |
26. Incomplete outcome data | High risk | 20.4% attrition in index group addressed. No data reported for control group. |
Baseline comparability | High risk | Differences in gender proportions: Index group 80.1% female and reference group 59.9% female Age groups were disproportionate: (18‐25 years) index 17.5%, reference 49.4%; (25‐34 years) index 38.7%, reference 21%; (35‐44 years) index 31%, reference 18.2% SES not specifically reported, but > 12 years of school was also disproportionate between groups: index 33.9%, reference 45.1%. Disease severity was incomparable in the index group (HIV+ persons) and reference group (healthy and undiagnosed, asymptomatic HIV+ people) |