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.

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http://dx.doi.org/10.1016/j.ijporl.2008.10.030DOI Listing

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