Abstract
BackgroundChild diarrhea persists as a leading public health problem in India despite evidence supporting zinc and low osmolarity oral rehydration salts as effective treatments. Across 2 years in 2010–2013, the Diarrhea Alleviation using Zinc and Oral Rehydration Salts Therapy (DAZT) program was implemented to operationalize delivery of these interventions at scale through private and public sector providers in rural Gujarat and Uttar Pradesh, India.Methods/DesignThis study evaluates the cost-effectiveness of DAZT program activities relative to status quo conditions existing before the study, comparing a Monte Carlo simulation method with net-benefit regression, discussing the strengths and weaknesses of each approach. A control group was not included in the ‘before and after’ study design as zinc has proven effectiveness for diarrhea treatment. Costs will be calculated using a societal perspective including program implementation and household out-of-pocket payments for care seeking, as well as estimates of wages lost. Outcomes will be measured in terms of episodes averted in net-benefit regression and in terms of the years of life lost component of disability-adjusted life years in the method based on Monte Carlo simulation. The Lives Saved Tool will be used to model anticipated changes in mortality over time and deaths averted based on incremental changes in coverage of oral rehydration salts and zinc. Data will derive from cross-sectional surveys at the start, midpoint, and endpoint of the program. In addition, Lives Saved Tool (LiST) projections will be used to define the reference case value for the ceiling ratio in terms of natural units.DiscussionThis study will be useful both in its application to an economic evaluation of a public health program in its implementation phase but also in its comparison of two methodological approaches to cost-effectiveness analysis. Both policy recommendations and methodological lessons learned will be discussed, recognizing the limitations in drawing strong policy conclusions due to the uncontrolled study design. It is expected that this protocol will be useful to researchers planning what method to use for the evaluation of similar before and after studies.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-014-0164-2) contains supplementary material, which is available to authorized users.
Highlights
Child diarrhea persists as a leading public health problem in India despite evidence supporting zinc and low osmolarity oral rehydration salts as effective treatments
Applying the Child Health Epidemiology Reference Group (CHERG) Rules for Evidence Review indicates that mortality reduction could be as much as 23%, and ideal data, from randomized controlled trials (RCTs), is unlikely to emerge as the strength of evidence in support of zinc makes these trials unethical [14]
Bootstrapping confidence intervals presents the problem of ambiguity in incremental cost-effectiveness ratios (ICERs), this problem can be circumvented in both methods using the net-benefit statistic, and both net-benefit regression and bootstrapping can be used to generate cost-effectiveness acceptability curves (CEACs)
Summary
Child diarrhea persists as a leading public health problem in India despite evidence supporting zinc and low osmolarity oral rehydration salts as effective treatments. Diarrhea is the fourth leading cause of mortality among children under 5, accounting for 9% of total deaths [1]. India is a priority area for addressing the remaining burden, recognized as one of 15 countries that account for 53% of total episodes worldwide, with 312.22 million episodes and 205,600 deaths each year nationwide [2]. Coverage of ORS in India remains low at less than 30%, and one out of ten children nationwide continues to experience diarrhea in any 2-week period [7]
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