Understanding the burden of congenital cytomegalovirus (cCMV) infection: concept elicitation interviews with caregivers of pediatric cCMV patients and development of a conceptual disease model.

PURPOSE: Congenital cytomegalovirus (cCMV) is the most common congenital infection worldwide. cCMV can result in long-term impairments such as hearing loss and developmental delay. The study objective was to understand the caregiver experience of cCMV and caregiver-reported perceptions of the experience for cCMV patients. METHODS: This non-interventional, cross-sectional study interviewed 25 caregivers of patients (aged 4 months to 17 years) with confirmed cCMV in the United States. Semi-structured qualitative interviewing methods were used to elicit descriptions of cCMV symptoms and their impact on the patient as perceived by the caregiver. Separate questions assessed the caregiver burden of a patient with cCMV. Transcripts were analyzed using an iterative coding process to identify key concepts. RESULTS: All caregivers reported increased healthcare needs for their child with cCMV. Other caregiver-reported patient impacts spanned multiple domains including emotional, physical and social functioning, education and communication. For example, a child with cCMV-related communication/hearing difficulties experiencing sadness or social isolation, or with cCMV-related seizures resulting in worry or apprehension. The caregiver impacts of caring for a child with cCMV also covered multiple domains including emotional, role and social functioning, work, sleep, and family planning. Emotional functioning was considered the greatest impact by approximately half of caregivers. CONCLUSION: These results advance understanding of experiences related to cCMV for caregivers and caregiver-reported perceptions of the patient experience. This may help healthcare professionals improve routine clinical practice for families affected by cCMV. The results and conceptual model may also support the development of a disease-specific clinical outcome assessment tool.