Modification of an outcome measure to follow symptoms of children with acute otitis media.

ABSTRACT

BACKGROUND: To modify a parent-reported acute otitis media severity of symptoms scale (AOM-SOS) to ensure that it accurately reflects parental concerns. METHODS: Using qualitative interviews with parents of children with acute otitis media (AOM) (n = 24), we generated 39 candidate items for inclusion in the new version of the scale. We determined the importance of each item by enrolling 50 other parents of children with AOM. We selected 15 items with high importance and used them to create a new version of the scale. During successive rounds of cognitive interviews, 3 items were dropped. Two additional items were dropped because they were highly correlated. We evaluated the psychometric properties of the new, 10-item version (version 6.0) in 139 children with AOM. RESULTS: AOM-SOS scores correlated with functional status (r = -0.53), parent assessment of child's pain level (r = 0.69), and overall symptom severity (r = 0.41). The internal consistency of the scale, as measured by Cronbach's alpha, was 0.90. Responsiveness (standardized response mean = 1.82) and test-retest reliability (0.77) were excellent and good, respectively. CONCLUSION: Data presented here support the use of the new version of the scale as a longitudinal measure of symptom burden in clinical trials of children with AOM. IMPACT STATEMENT The AOM-SOS scale, which now incorporates parental views, can be used to track symptom severity in future efficacy trials in young children with acute otitis media. Data is presented on the validity, reliability, and responsiveness of the AOM-SOS scale. Otitis media is the most frequent indication for antibiotic use in young children. The AOM-SOS is one of the few validated disease specific scales available for use in efficacy trials of children with acute otitis media.