Linnemayr 2013.
Methods | Longitudinal, prospective cohort study (CBA study) | |
Participants | 602 HIV+ treatment‐naive clients, 18 years of age or older, who were newly evaluated for ART from 2 Joint Clinical Research Centres in Kampala (urban) and Kakira (rural), Uganda.
Index: 300 HIV+ people initiating ART with CD4 count < 250 cells/mm3 (WHO disease stage III or IV) and had a 'treatment supporter' Control: 302 HIV+ people pre‐ART with CD4 count < 400 cells/mm3 |
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Interventions | All participants underwent structured interview concerning background characteristics, physical and mental health status, and economic outcomes. Health data abstracted from patient medical records. Assessments taken at 0 and 12 months. Index: ART provided by Joint Clinical Research Centre HIV Clinic, plus general HIV treatment Control: General HIV treatment, no ART |
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Outcomes | Employment: 1. Work status in the week preceding interview Other health‐related economic outcomes: 2. Health interference with work (binary indicator of perceived health effect on work) 3. Pain interference with work in last month (5‐point scale from 'not at all' to 'extremely') 4. Work‐related self efficacy (single visual analogue scale 0‐10) |
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Notes | Rand Corporation (California, USA) Joint Clinical Research Centre (Kampala, Uganda) Funding: The Rockfeller Foundation, Grant No. HE007;PIGWagner Participants received 5000 Uganda Shillings (˜USD 2.50) for completion of each interview |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
14. Blinding (Subjects) | Unclear risk | No blinding, however due to a dichotomous outcome of employed or unemployed in past 7 days, this should not have affected the results. |
15. Blinding (outcome assessors) | Low risk | No blinding, objective outcomes should have been unaffected by lack of outcome assessor blinding. |
16. Retrospective unplanned subgroup analysis | Low risk | No evidence of retrospective unplanned subgroup analysis. |
17. Follow‐up | Low risk | Follow‐ups conducted at 6 and 12 months in both index and reference groups. Approximately 5% loss to attrition. |
18. Statistical tests | Low risk | Two‐tailed t‐test, Chi2 test (has statistically low power when study has small sample size (n = 602)). Performed 2 sensitivity analyses:
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19. Compliance | Unclear risk | ART adherence is required for survival, therefore compliance, although not monitored, is highly likely. Eligibility for the index group required the HIV+ persons have a 'treatment supporter' for adherence. |
20. Outcome measures | Low risk | All predetermined outcome measures reported. |
21. Selection Bias (population) | Unclear risk | Eligible patients were approached by clinic staff when ART eligibility was assessed. No randomization. Intention‐to‐treat analysis was utilized to avoid control‐group members changing to the index group. |
22. Selection bias (time) | Unclear risk | Recruitment timeline not specified. 2008? |
23. Randomization | Unclear risk | Non‐randomized. Participants were predetermined to index and reference groups by ART eligibility status. |
24. Allocation concealment | Unclear risk | Non‐randomized. Did not report the use of adequate sequence generation or allocation concealment techniques. |
25. Adjustment for confounding | Unclear risk | Stratified data by gender and included physical health and mental health confounders. Did not account for age, SES, or education. |
26. Incomplete outcome data | Low risk | < 5% attrition, and all outcome data reported. |
Baseline comparability | Unclear risk | As expected, baseline health differences were present between the index and reference groups due to disease progression and need for treatment. However, authors claim to have performed a sensitivity analysis and reported that the overall results did not change. However, data was not presented in the publication. |