Table 1. Summary of analysis boundaries.
Issues for consideration | Approach chosen | Justification of choice |
Objectives of analysis | Cost analysis: to calculate total financial and economic costs and cost-efficiency of the intervention.Cost-effectiveness analysis: to calculate cost per improvement in coprimary outcomes (maternal perinatal depression at 12 months postnatal and child cognitive development at 24 months of age) and to compare costs to a vector of benefits, including indicative estimates of long-term gains, such as improved education outcomes and increased income in adulthood. | These are the most feasible objectives for analysis, given the time and resource constraints. |
Audience | Researchers, healthcare workers and policy makers | Health economic evaluation commissioned by trial team. |
Viewpoint | Societal perspective | Useful to multiple stakeholders to determine appropriate resource allocation. |
Time | ||
a)Time of the intervention | April 2018 to December 2023 | As per updated RCT protocol, with delays in measuring coprimary outcomes due to the COVID-19 pandemic. |
b)Time over which benefits experienced | Approximately third trimester until 24 months post partum. | Benefits should be realised from the start of therapy (third trimester) until the final coprimary outcomes are measured at 24 months post partum. |
Analytical horizon | The outcomes time horizon will run from when the first coprimary outcomes are measured (2019) until the final coprimary outcomes are measured (2024), that is, 5 years.The costing time horizon will run from inception (2016) until all therapy sessions are completed (2023), that is, 8 years. | The benefits time horizon will be updated to ensure that it matches the costs time horizon. |
Which alternatives could be used for comparison? | Enhanced standard of care (ESoC) | ESoC provided to participants in the control arm of the trial. |
Target population(s) | Pregnant women who are diagnosed HIV-positive; aged 16 years and above (all participants were above 18); meet the criteria for antenatal depression as defined by a score of ≥9 on the Edinburgh Postnatal Depression Scale; live or are planning to live within the study area at the time of delivery and for at least 9 months after delivery (intensive therapy period); are conversant in isiZulu or English. Exclusion criteria may be found in Rochat et alhere. in Rochat et al..1 | HIV-positive women have a higher risk of developing perinatal depression and they and their infants suffer from worse consequences thereof. |
Coverage | To be implemented at 88% (15/17) of clinics in the district. | These clinics are research sites for a research centre. |
Type of analysis | Cost-effectiveness analysis | Cost and consequences data are collected for the interventions and comparator. |
RCTrandomised controlled trial