Methodological choices for an economic evaluation of a combined psychosocial and nutrition treatment intervention for children with severe acute malnutrition: The FUSAM trial in Nepal.

As a public health burden, severe acute malnutrition (SAM) among children has been increasingly studied to determine the optimal combination of treatment approaches. Among the new approaches is the addition of early childhood development sessions to standard nutrition-based treatment for SAM which can enhance both nutrition and development outcomes among young children. However, few studies demonstrate the relationship between the costs of such combined programs and the benefits accrued to the children and their caregivers. This article describes our experience of designing and conducting an economic evaluation alongside a cluster randomized controlled trial assessing a combined nutrition and psychosocial intervention for the treatment of SAM in children aged 6-24 months in Nepal. We present key lessons learned regarding methodological choices, the challenges of field data collection, as well as study adjustment when data analysis did not unfold as anticipated. With the view to transparency, this manuscript provides some clarifications on the evaluation processes for funders and policy makers on what economic evaluations entail and what information they convey for the purpose of supporting policy decision-making around limited resource allocation.

The cost of preventing undernutrition: cost, cost-efficiency and cost-effectiveness of three cash-based interventions on nutrition outcomes in Dadu, Pakistan.

Cash-based interventions (CBIs) increasingly are being used to deliver humanitarian assistance and there is growing interest in the cost-effectiveness of cash transfers for preventing undernutrition in emergency contexts. The objectives of this study were to assess the costs, cost-efficiency and cost-effectiveness in achieving nutrition outcomes of three CBIs in southern Pakistan: a 'double cash' (DC) transfer, a 'standard cash' (SC) transfer and a 'fresh food voucher' (FFV) transfer. Cash and FFVs were provided to poor households with children aged 6-48 months for 6 months in 2015. The SC and FFV interventions provided $14 monthly and the DC provided $28 monthly. Cost data were collected via institutional accounting records, interviews, programme observation, document review and household survey. Cost-effectiveness was assessed as cost per case of wasting, stunting and disability-adjusted life year (DALY) averted. Beneficiary costs were higher for the cash groups than the voucher group. Net total cost transfer ratios (TCTRs) were estimated as 1.82 for DC, 2.82 for SC and 2.73 for FFV. Yet, despite the higher operational costs, the FFV TCTR was lower than the SC TCTR when incorporating the participation cost to households, demonstrating the relevance of including beneficiary costs in cost-efficiency estimations. The DC intervention achieved a reduction in wasting, at $4865 per case averted; neither the SC nor the FFV interventions reduced wasting. The cost per case of stunting averted was $1290 for DC, $882 for SC and $883 for FFV. The cost per DALY averted was $641 for DC, $434 for SC and $563 for FFV without discounting or age weighting. These interventions are highly cost-effective by international thresholds. While it is debatable whether these resource requirements represent a feasible or sustainable investment given low health expenditures in Pakistan, these findings may provide justification for continuing Pakistan's investment in national social safety nets.

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

BACKGROUND: 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. METHOD: 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. DISCUSSION: 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. TRIAL REGISTRATION: ISRCTN 30393230 , date: 16/03/2017.

The REFANI-N study protocol: a cluster-randomised controlled trial of the effectiveness and cost-effectiveness of early initiation and longer duration of emergency/seasonal unconditional cash transfers for the prevention of acute malnutrition among children, 6-59 months, in Tahoua, Niger.

BACKGROUND: The global burden of acute malnutrition among children remains high, and prevalence rates are highest in humanitarian contexts such as Niger. Unconditional cash transfers are increasingly used to prevent acute malnutrition in emergencies but lack a strong evidence base. In Niger, non-governmental organisations give unconditional cash transfers to the poorest households from June to September; the 'hunger gap'. However, rising admissions to feeding programmes from March/April suggest the intervention may be late. METHODS/DESIGN: This cluster-randomised controlled trial will compare two types of unconditional cash transfer for 'very poor' households in 'vulnerable' villages defined and identified by the implementing organisation. 3,500 children (6-59 months) and 2,500 women (15-49 years) will be recruited exhaustively from households targeted for cash and from a random sample of non-recipient households in 40 villages in Tahoua district. Clusters of villages with a common cash distribution point will be assigned to either a control group which will receive the standard intervention (n = 10), or a modified intervention group (n = 10). The standard intervention is 32,500 FCFA/month for 4 months, June to September, given cash-in-hand to female representatives of 'very poor' households. The modified intervention is 21,500 FCFA/month for 5 months, April, May, July, August, September, and 22,500 FCFA in June, providing the same total amount. In both arms the recipient women attend an education session, women and children are screened and referred for acute malnutrition treatment, and the households receive nutrition supplements for children 6-23 months and pregnant and lactating women. The trial will evaluate whether the modified unconditional cash transfer leads to a reduction in acute malnutrition among children 6-59 months old compared to the standard intervention. The sample size provides power to detect a 5 percentage point difference in prevalence of acute malnutrition between trial arms. Quantitative and qualitative process evaluation data will be prospectively collected and programme costs will be collected and cost-effectiveness ratios calculated. DISCUSSION: This randomised study design with a concurrent process evaluation will provide evidence on the effectiveness and cost-effectiveness of earlier initiation of seasonal unconditional cash transfer for the prevention of acute malnutrition, which will be generalisable to similar humanitarian situations. TRIAL REGISTRATION: ISRCTN25360839, registered March 19, 2015.

The REFANI Pakistan study--a cluster randomised controlled trial of the effectiveness and cost-effectiveness of cash-based transfer programmes on child nutrition status: study protocol.

BACKGROUND: Cash-based transfer programmes are an emerging strategy in the prevention of wasting in children, especially targeted at vulnerable households during periods of food insecurity or during emergencies. However, the evidence surrounding the use of either cash or voucher transfer programmes in the humanitarian context and on nutritional outcomes is elusive. More evidence is needed not only to inform the global community of practice on best practices in humanitarian settings, but also to help strengthen national mitigation responses. METHODS/DESIGN: The Research for Food Assistance on Nutrition Impact Pakistan study (REFANI-P) sets out to evaluate the impact of three cash-based interventions on nutritional outcomes in children aged less than five years from poor and very poor households in Dadu District. This four-arm parallel cluster randomised controlled trial is set among Action Against Hunger (ACF) programme villages in Dadu District, Sindh Province. Mothers are the target recipients of either seasonal unconditional cash transfers or fresh food vouchers. A comparison group receives 'standard care' provided by the ACF programme to which all groups have the same access. The primary outcomes are prevalence of wasting and mean weight-for-height Z-score (WHZ) in children. Impact will be assessed at 6 months and at 1 year from baseline. Using a theory-based approach we will determine 'how' the different interventions work by looking at the processes involved and the impact pathways following the theory of change developed for this context. Quantitative and qualitative data are collected on morbidity, health seeking, hygiene and nutrition behaviours, dietary diversity, haemoglobin concentration, women's empowerment, household food security and expenditures and social capital. The direct and indirect costs of each intervention borne by the implementing organisation and their partners as well as by beneficiaries and their communities are also assessed. DISCUSSION: The results of this trial will provide robust evidence to help increase knowledge about the predictability of how different modalities of cash-based transfer work best to reduce the risk of child wasting during a season where food insecurity is at its highest. Evidence on costing and cost-effectiveness will further aid decisions on choice of modality in terms of effectiveness and sustainability. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10761532 . Registered 26 March 2015.