The Chronic Otitis Media Benefit Inventory (COMBI): Development and Validation of a Dynamic Quality of Life Questionnaire for Chronic Ear Disease.

Objective: This study introduces a change-oriented shortform health-related quality of life questionnaire suited to symptoms of adult chronic middle ear disease and its consequences, and describes its properties. Study Design: Two-centre prospective correlational study primarily for instrument development. Setting: Two otology secondary care centers in England. Patients: Fifty-two consecutive adult patients with active chronic otitis media undergoing surgery. Methods: The 12 items for the chronic otitis media benefit inventory (COMBI) were appraised chiefly for internal consistency of resulting score and for factor structure (exploratory factor analysis). Results: The internal consistency of the COMBI was high within our cohort of patients, with a Cronbach's alpha value of 0.907. The three-factor solution from factor analysis explaining 73.6% of the variance was readily interpretable in terms of the intended item content: changes in hearing, ear symptoms, and daily activities plus healthcare uptake. Conclusions: The COMBI has suitable properties for the dynamic assessment of active chronic otitis media. Initial psychometric appraisal confirms its suitability for early adoption to acquire more comprehensive large-sample information with it and on it, for future refinement and application.