Evaluating the cost-effectiveness of new treatment strategies for the management of young infants with low- or moderate-mortality risk signs of possible serious bacterial infection: Framework and study methodology

BackgroundThe World Health Organization (WHO) is coordinating two randomized controlled trials (RCTs) across three sites in Africa (Ethiopia, Nigeria and Tanzania) and four in Asia [Bangladesh, India (two) and Pakistan] to generate evidence on the optimal place of treatment for young infants with a single low-mortality risk sign of possible serious bacterial infection (PSBI) and switching antibiotic therapy from injectable to oral in young infants with moderate-mortality risk signs of PSBI. This paper presents the framework and methodology used to compare the costs and evaluate the cost-effectiveness of these strategies. MethodsCost analysis will be conducted from societal (both hospital and household) perspectives. Hospital direct medical costs (staff, medicines, consumables), direct non-medical costs (inpatient bed costs and transport expenses), and indirect operational costs (management, administration, non-consumables, training, and communication) will be gathered using hospital surveys. Household costs, including direct medical payments for treatment (registration, consultation, medications, consumables, and laboratory tests) and non-medical costs of transport, food and boarding, will be collected using household surveys. In both RCTs, combined hospital and household costs (for medical and non-medical) will be used to calculate the cost per sick young infant in each study arm. Effectiveness measures, based on the absence of adverse outcomes, will be used to determine incremental cost-effectiveness ratios. Household wage loss will estimate the household burden per treated child, and indirect hospital costs will highlight additional health system burdens. DiscussionThis cost-effectiveness framework evaluates PSBI treatment in young infants, integrating health system and household perspectives. It seeks to identify safe, economical regimes to reduce economic burdens, inform national budget impact, and potentially prompt WHO guideline revisions for better infant care in low-resource settings globally.