Lelijveld Natasha, Bailey Jeanette, Mayberry Amy, Trenouth Lani, N'Diaye Dieynaba S, Haghparast-Bidgoli Hassan, Puett Chloe
No Wasted Lives, Action Against Hunger UK, London, UK.
Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Trials. 2018 Apr 24;19(1):252. doi: 10.1186/s13063-018-2594-7.
Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM.
This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant.
We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies.
ISRCTN 30393230 , date: 16/03/2017.
目前，急性营养不良根据消瘦程度分为重度（SAM）和中度（MAM）。SAM和MAM目前有各自独立的治疗方案和产品，由不同的国际机构管理。对于SAM，治疗剂量根据儿童体重分配。一种针对SAM和MAM的联合简化方案，采用标准化剂量的即食治疗食品（RUTF），正在进行试验，以验证其恢复率不劣于现有方案，并且可能比目前治疗SAM和MAM的标准方案更具成本效益。
这是ComPAS试验经济评估的方案，该试验是一项整群随机对照的非劣效性试验，比较了一种治疗单纯性急性营养不良的新型联合方案与南苏丹和肯尼亚目前的标准方案。我们将从社会角度，利用会计数据、访谈和调查问卷来计算两种方案的总经济成本。将估算实施联合方案的增量成本，所有成本和结果将以成本后果分析的形式呈现。如果具有统计学显著性，将计算主要和次要结果的增量成本效益比。
我们假设，实施联合方案将具有成本效益，原因在于诊所层面的物流简化、治疗时间缩短（尤其是MAM）以及RUTF剂量减少。鉴于主要健康结果假设为非劣效，本次经济评估的结果对政策制定者而言将非常重要。本方案的发布旨在提高实施的严谨性以及数据收集和分析的透明度。它还旨在促进在其他营养干预研究中纳入经济评估，尤其是针对MAM的研究，并提高与其他研究的可比性。
ISRCTN 30393230，日期：2017年3月16日。
