BACKGROUND AND AIMS: Congenital CMV (cCMV) is the major infectious cause of birth defects and a leading cause of sensorineural hearing loss and neurodevelopmental disability. Childhood illness and long-term sequelae impose significant financial costs, impact on health-related quality of life (HRQoL), and health strains on family members of those with cCMV (family “spillover” effects). Quantifying the spillover impacts associated with cCMV disease and sequelae, including indirect costs, will be critical for describing the full economic and societal impact of cCMV. The overall aim of this study is to examine the spillover effects of childhood cCMV disease on families, including quantifying HRQoL, health-utility impacts, and financial costs for medical travel, caregiver time, specialized preschool/education, specialized housing, home adaptations, personal care, and lost work productivity.
METHODS: A noninterventional, cross-sectional, observational study is ongoing in the US and Canada. The study population includes children aged 0-17 years with a caregiver-reported diagnosis of cCMV, primary caregivers of the child, and siblings aged ≥4 years who live in the same home as the child. US participants are recruited via the National CMV Foundation, whereas Canadian participants are recruited via CMV Canada. Convenience samples are utilized with target study sizes of 300 children with diagnosed cCMV (stratified by the following age groups: 0-4 years, 5-7 years, and 8-17 years), 300 caregivers, and 50 siblings in the US and target study sizes of 50 children with diagnosed cCMV, 50 caregivers, and 10 siblings in Canada. Patient-reported outcome measures (self-reported or caregiver-assisted/completed) are collected online via three separate surveys. The child survey includes HRQoL, activities of daily living, health state utilities, and demographic/clinical characteristics. The caregiver survey includes work productivity, activity impairment, HRQoL, direct nonmedical care costs of cCMV diagnosed children, health state utilities, and demographic/socioeconomic characteristics. The sibling survey includes HRQoL, health state utilities, and demographic characteristics.
RESULTS: Data collection is ongoing; descriptive results may be presented.
CONCLUSIONS: Quantifying the indirect costs and family spillover associated with cCMV disease will be critical for supporting the economic and societal impact of a future CMV vaccine.
