PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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 et al\'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.
BACKGROUND: 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.
UNASSIGNED: ISRCTN registry #11 284 870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).
METHODS: 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 et al\'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.
BACKGROUND: 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.
UNASSIGNED: ISRCTN registry #11 284 870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).
摘要：
背景：贫困，艾滋病毒和围产期抑郁症对撒哈拉以南非洲的公共卫生构成三重威胁，因为它们对育儿和儿童发育产生了共同的负面影响。在低收入和中等收入国家资源有限的情况下，由外行顾问提供的干预措施结合了心理干预和育儿干预措施,有可能减轻围产期抑郁症的后果,同时还能优化稀缺的医疗保健资源.衡量这种新颖干预措施的成本效益将有助于决策者更好地了解与复制干预措施相关的相对成本和效果。从而支持基于证据的决策。该协议规定了分析整群随机对照试验（RCT）的成本效益的方法学框架，该试验将综合干预措施与治疗抑郁症时增强的护理标准进行比较。南非农村地区艾滋病毒呈阳性的孕妇及其婴儿。
方法：此成本效益分析（CEA）方案符合2022年综合卫生经济评估报告标准清单。将选择社会视角。所提出的方法将根据随机对照试验方案确定实施干预的成本和效率。以及在非研究环境中复制干预的成本。将使用经过适当调整的标准化幼儿发展成本计算工具版本来计算成本。主要健康结果将与成本结合使用，以确定产后12个月孕产妇围产期抑郁症的每次改善成本以及24个月儿童认知发育的每次改善成本。为了便于优先级设置，根据Verguet等人的方法(2022年),儿童认知发展改善的增量成本效益比将与其他6种儿童认知发展干预措施进行排名.基于活动和基于成分的成本计算方法的组合将用于确定，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。
背景：牛津大学是CEA的赞助商。伦理批准已获得人类科学研究委员会(HSRC，#REC5/23/08/17),南非和牛津热带研究伦理委员会（OxTREC＃31-17），英国。对于发布的同意是不适用的,因为在该协议中没有使用参与者数据。我们计划以政策简介的形式向主要决策者和研究人员传播CEA结果，会议和学术论文。
■ISRCTN注册表＃11284870（14/11/2017）和SANCTRDOH-27-102020-9097（17/11/2017）。
方法：此成本效益分析（CEA）方案符合2022年综合卫生经济评估报告标准清单。将选择社会视角。所提出的方法将根据随机对照试验方案确定实施干预的成本和效率。以及在非研究环境中复制干预的成本。将使用经过适当调整的标准化幼儿发展成本计算工具版本来计算成本。主要健康结果将与成本结合使用，以确定产后12个月孕产妇围产期抑郁症的每次改善成本以及24个月儿童认知发育的每次改善成本。为了便于优先级设置，根据Verguet等人的方法(2022年),儿童认知发展改善的增量成本效益比将与其他6种儿童认知发展干预措施进行排名.基于活动和基于成分的成本计算方法的组合将用于确定，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。
背景：牛津大学是CEA的赞助商。伦理批准已获得人类科学研究委员会(HSRC，#REC5/23/08/17),南非和牛津热带研究伦理委员会（OxTREC＃31-17），英国。对于发布的同意是不适用的,因为在该协议中没有使用参与者数据。我们计划以政策简介的形式向主要决策者和研究人员传播CEA结果，会议和学术论文。
■ISRCTN注册表＃11284870（14/11/2017）和SANCTRDOH-27-102020-9097（17/11/2017）。
