Introduction Undernutrition affects ∼165 million children globally and contributes up to 45% of all child deaths. India has the highest proportion of global undernutrition-related morbidity and mortality. This protocol describes the planned economic evaluation of a community-based intervention to improve growth in children under 2 years of age in two rural districts of eastern India. The intervention is being evaluated through a cluster-randomised controlled trial (cRCT, the CARING trial).
Methods and analysis A cost-effectiveness and cost–utility analysis nested within a cRCT will be conducted from a societal perspective, measuring programme, provider, household and societal costs. Programme costs will be collected prospectively from project accounts using a standardised tool. These will be supplemented with time sheets and key informant interviews to inform the allocation of joint costs. Direct and indirect costs incurred by providers will be collected using key informant interviews and time use surveys. Direct and indirect household costs will be collected prospectively, using time use and consumption surveys. Incremental cost-effectiveness ratios (ICERs) will be calculated for the primary outcome measure, that is, cases of stunting prevented, and other outcomes such as cases of wasting prevented, cases of infant mortality averted, life years saved and disability-adjusted life years (DALYs) averted. Sensitivity analyses will be conducted to assess the robustness of results.
Ethics and dissemination There is a shortage of robust evidence regarding the cost-effectiveness of strategies to improve early child growth. As this economic evaluation is nested within a large scale, cRCT, it will contribute to understanding the fiscal space for investment in early child growth, and the relative (in)efficiency of prioritising resources to this intervention over others to prevent stunting in this and other comparable contexts. The protocol has all necessary ethical approvals and the findings will be disseminated within academia and the wider policy sphere.
Trial registration number ISRCTN51505201; pre-results.
- PUBLIC HEALTH
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Contributors JS-W, HH-B and RS designed the protocol for the Economic Evaluation and prepared the first draft of the paper. NN, PT and AP conceived and designed the CARING trial in which this study is embedded. JS-W, HH-B, NB and A-MP-B designed the cost capture systems and the processes for allocating and synthesising costs. RS, HH-B, AKO, SS and RG field tested all data collection forms and substantively contributed to their design. AKO, SS, NN, PT, HSS, SB, RG, ShiR, SucR, AS, NB, A-MP-B, AnthC, AndrC, NS and AP all commented on the first draft of the paper and contributed revisions to the content. All authors have read and approve the submitted manuscript.
Funding The CARING trial is funded by UK Medical Research Council (MR/K007270/1), the Wellcome Trust (099708/Z/12/Z) and the Department for International Development (DfID) under their joint Global Health Trial Scheme.
Competing interests None declared.
Ethics approval The study received ethical approval from the research ethics committee of the Public Health Foundation of India (June 2013, TRC-IEC-163/13), an Independent Ethics Committee linked to Ekjut (May 2013), and University College London's Research Ethics Committee (June 2013, reference 1881/002).
Provenance and peer review Not commissioned; externally peer reviewed.
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