The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation

Abstract

BackgroundAcute 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.MethodThis 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.DiscussionWe 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.Trial RegistrationISRCTN 30393230, date: 16/03/2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2594-7) contains supplementary material, which is available to authorized users.

A simplified, combined protocol versus standard treatment for acute malnutrition in children 6–59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan

“…To assess cost-effectiveness, we calculated costs from a societal perspective, using accounting data, interviews with key informants, and survey questionnaires given to a subset of staff and all caregivers. Details have been described in our cost analysis methods paper [34]. We categorized costs into treatment, outreach, supply logistics, supervision, management, and household costs for each country.…”

“…The clinical trial described in this paper builds on analysis conducted by our team to develop a simplified, combined protocol [25]. We previously published a full description of the protocol for this trial, as well as the methods for the cost-effectiveness analyses [33,34]. Ethical approval was given by the London School of Hygiene & Tropical Medicine (reference 11826), the Kenya Medical Research Institute (reference non-KEMRI 551), and the Ministry of Health in South Sudan (approved 21 November 2016).…”

“…The cost savings assessed in this trial were limited in scope. Though our method for assessing cost-effectiveness removed many of the research-specific costs [34], it was not possible to fully separate research versus programming costs in the analysis, so the total cost per child is higher than in many program settings. The costs reflect the combined inputs of NGOs and ministries of health, both of which contributed to the treatment of children.…”

Acute malnutrition recovery energy requirements based on mid-upper arm circumference: Secondary analysis of feeding program data from 5 countries, Combined Protocol for Acute Malnutrition Study (ComPAS) Stage 1

“…Therefore, an additional aspect of cost savings is not just the reduction in SAM cases, but the reduced dosage of RUTF used for SAM. We will need to see this play out in operational studies in multiple countries to assess the practical implications, and that is what the UN and non-governmental organizations (NGOs) are doing now [63].…”

Can community health workers manage uncomplicated severe acute malnutrition? A review of operational experiences in delivering severe acute malnutrition treatment through community health platforms

“…The Combined Protocol for Acute Malnutrition Study (ComPAS), currently implemented in South Sudan and Kenya, is exploring some of these potential protocol modifications. The study aims to assess the effectiveness and cost‐effectiveness of a reduced and standardized dose of RUTF to treat severe and moderate acute malnutrition (Bailey et al, ; Lelijveld et al, ). Reduced dosage of RUTF has already shown potential in trials in Myanmar, where a reduced dosage protocol used to treat over 3,000 children with SAM achieved 90.2% recovery with 2.0% of default rates, 0.9% of non‐respondents, and no deaths registered (James et al, ).…”