Quality of life in children with chronic suppurative otitis media with or without cholesteatoma.

Summary Objective To validate a disease-specific health related quality of life (HRQOL) instrument for children with chronic suppurative otitis media with or without cholesteatoma. Methods Caregivers of 45 children with chronic suppurative otitis media, who were offered an operation (tympanoplasty or radical mastoidectomy) in a tertiary children's hospital, were administered a 5-item quality of life survey (COM-5) The COM-5, which is a modified version of OM-6, was administered four times: few weeks and few days before operation and six months and one year postoperatively. Psychometric characteristics and more specifically test-retest reliability, internal consistency, construct validity, and responsiveness to clinical change of the COM-5 score were the main outcome measures. Results Median COM-5 score was 2.6 (1- to 7-point scale) with higher scores indicating poorer quality of life. Test-retest reliability was good (interclass correlation coefficient = 0.73) Construct validity was demonstrated by significant correlations between COM-5 score and global ear-related quality of life ( R  = −0.485), between physical suffering and ear-related physician visits ( R  = 0.41) and between caregiver concerns vs ear-related physician visits ( R  = 0.44). The mean change in COM-5 score after successful tympanoplasty was 1.1 and correlated well with the change of global ear-related quality of life rating ( R  = −0.545) as well as with the degree of clinical change reported by the caregiver ( R  = 0.494). The mean standardized response was 1.3 after tympanoplasty indicating the instrument's large responsiveness to clinical change after this procedure, but only 0.7 after radical mastoidectomy. Conclusions The COM-5 is a valid, reliable and responsive instrument. Apart from its satisfactory psychometric characteristics, it can be easily administered in caregivers of children who require a tympanoplasty due to chronic suppurative otitis media.