There are no reliable and valid instruments that measure otitis media clinical or functional health status in children ages 1 to 3 years. This study develops and tests three new instruments of clinical and functional otitis health status: the Otitis Media Clinical Severity Index (OM-CSI), the Otitis Media Functional Status Questionnaire (OM-FSQ), and the Otitis Media Diary (OMD). The OM-CSI was found to be a reliable measure of clinical acute otitis media (AOM) severity, with high internal consistency (Cronbach's α) scores, as well as an accurate indicator of AOM severity. The OM-FSQ and OMD were demonstrated to be reliable and valid measures of otitis-specific functional health status, with reproducible scores over time, high internal consistency α scores, and high correlation with measures of AOM clinical severity and other functional health status instruments. These three new instruments were also sensitive and specific indicators of AOM episodes.
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