Validations of the OM-6 Parent-Proxy Survey for Infants/Toddlers with Otitis Media

Objective To validate the Otitis Media-6 (OM-6), a parent-proxy quality-of-life (QOL) questionnaire for infants/young children with OM, against other previously validated generic QOL questionnaires. Study Design Multi-institutional cross-sectional study. Setting Twenty-three otolaryngology, pediatric, and family practices across the United States. Subjects and Methods Caregivers of 6- to 24-month-old children with a history of OM completed the OM-6, OM History Form, and Pediatric Quality of Life (PedsQL) Infant Scales survey. Principal components analysis (PCA) examined the underlying factor structure of items on the OM-6, and Cronbach's α measured the internal consistency of items on each factor. Discriminant validity was assessed with receiver operating curves (ROCs). Results Surveys from 1045 patients were analyzed. The overall OM-6 was strongly to moderately correlated with the PedsQL Infant Scales scores (Pearson r = -0.649 for ages 6-12 months and -0.566 for ages 13-24 months). Two underlying constructs, "Behavior and Symptoms" and "Hearing and Speech," emerged from the PCA. Each factor and the overall OM-6 showed excellent internal consistency reliability (each Cronbach's α >0.75). The areas under the curve on the ROC analyses were <0.65 for recurrent and chronic OM using a variety of frequency and chronicity cut-points and definitions. Conclusion The OM-6 measures 2 underlying QOL constructs, Behavior and Symptoms and Hearing/Speech. The overall OM-6 showed acceptably high internal consistency reliability and good construct validity. However, the ability of the OM-6 to identify children who have more severe clinical recurrent or chronic OM vs milder disease was not supported by our analysis.