Department of Economics, Faculty of Economics and Management Sciences, University of the Western Cape, Bellville, South Africa
Health Systems and Public Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
BMJ Open. 2024 Aug 3;14(8):e082977. doi: 10.1136/bmjopen-2023-082977.
Poverty, HIV and perinatal depression represent a triple threat to public health in sub-Saharan Africa because of their combined negative effects on parenting and child development. In the resource-constrained context of low-income and middle-income countries, a lay-counsellor-delivered intervention that combines a psychological and parenting intervention could offer the potential to mitigate the consequences of perinatal depression while also optimising scarce resources for healthcare.Measuring the cost-effectiveness of such a novel intervention will help decision-makers to better understand the relative costs and effects associated with replicating the intervention, thereby supporting evidence-based decision-making. This protocol sets out the methodological framework for analysing the cost-effectiveness of a cluster randomised controlled trial (RCT) that compares a combined intervention to enhanced standard of care when treating depressed, HIV-positive pregnant women and their infants in rural South Africa.
This cost-effectiveness analysis (CEA) protocol complies with the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. A societal perspective will be chosen.The proposed methods will determine the cost and efficiency of implementing the intervention as per the randomised control trial protocol, as well as the cost of replicating the intervention in a non-research setting. The costs will be calculated using an appropriately adjusted version of the Standardised Early Childhood Development Costing Tool.Primary health outcomes will be used in combination with costs to determine the cost per improvement in maternal perinatal depression at 12 months postnatal and the cost per improvement in child cognitive development at 24 months of age. To facilitate priority setting, the incremental cost-effectiveness ratios for improvements in child cognitive development will be ranked against six other child cognitive-development interventions according to Verguet 's methodology (2022).A combination of activity-based and ingredient-based costing approaches will be used to identify, measure and value activities and inputs for all alternatives. Outcomes data will be sourced from the RCT team.
The University of Oxford is the sponsor of the CEA. Ethics approval has been obtained from the Human Sciences Research Council (HSRC, #REC 5/23/08/17), South Africa and the Oxford Tropical Research Ethics Committee (OxTREC #31-17), UK.Consent for publication is not applicable since no participant data are used in this protocol.We plan to disseminate the CEA results to key policymakers and researchers in the form of a policy brief, meetings and academic papers.
ISRCTN registry #11 284 870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).
贫困、艾滋病毒和围产期抑郁症是撒哈拉以南非洲公共卫生的三重威胁，因为它们对育儿和儿童发展都有负面影响。在资源有限的低收入和中等收入国家的背景下，一种由非专业顾问提供的结合了心理和育儿干预的干预措施可能有潜力减轻围产期抑郁症的后果，同时优化医疗保健的稀缺资源。衡量这种新干预措施的成本效益将有助于决策者更好地理解复制该干预措施所涉及的相对成本和效果，从而支持循证决策。本方案为分析一项比较在南非农村地区治疗艾滋病毒阳性孕妇及其婴儿的综合干预措施与增强标准护理的成本效益的群组随机对照试验 (RCT) 的成本效益分析 (CEA) 制定了方法框架。
本 CEA 方案符合 2022 年卫生保健经济评估报告标准核对清单。将选择一个社会视角。拟议的方法将根据随机对照试验方案确定实施干预措施的成本和效率，以及在非研究环境中复制干预措施的成本。将使用适当调整的标准化早期儿童发展成本工具版本计算成本。主要健康结果将与成本结合使用，以确定产后 12 个月时产妇围产期抑郁改善的每单位成本和 24 个月时儿童认知发展改善的每单位成本。为了便于确定优先事项，根据 Verguet 的方法（2022 年），将改善儿童认知发展的增量成本效益比与其他六种儿童认知发展干预措施进行排名。将使用基于活动和基于成分的成本核算方法来确定、衡量和评估所有替代方案的活动和投入。结果数据将来自 RCT 团队。
牛津大学是该 CEA 的赞助商。该方案已获得南非人类科学研究理事会（HSRC，#REC 5/23/08/17）和牛津热带研究伦理委员会（OxTREC #31-17）的伦理批准。由于本方案不使用任何参与者数据，因此无需发表同意。我们计划以政策简报、会议和学术论文的形式向关键政策制定者和研究人员传播 CEA 结果。
ISRCTN 注册 #11 284 870（2017 年 11 月 14 日）和 SANCTR DOH-27-102020-9097（2017 年 11 月 17 日）。
