Otitis media health status evaluation: a pilot study for the investigation of cost-effective outcomes of recurrent acute otitis media treatment.

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 alpha) 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 alpha 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.