BACKGROUND: The Chronic Otitis Media Questionnaire-12 (COMQ-12) is a disease-specific health-related quality of life (HRQoL) instrument originally developed in English for patients with chronic otitis media (COM). This study aimed to translate the COMQ-12 into German and to validate the resulting German version, and assess its psychometric properties.

METHODS: The COMQ-12 underwent forward-backward translation into German. Seventy-nine patients with COM who underwent middle ear surgery were prospectively enrolled. HRQoL was assessed preoperatively and 6 months postoperatively via the German COMQ-12. Additionally, pure tone audiometry was performed at both time points. Psychometric properties, including internal consistency, test-retest reliability, discriminant validity, agreement validity, responsiveness, and response shift, were evaluated.

RESULTS: The German COMQ-12 demonstrated high internal consistency both preoperatively (Cronbach's α = 0.87) and postoperatively (Cronbach's α = 0.84). The test-retest reliability was high (r = 0.89). It significantly discriminated between COM patients and healthy controls (p < 0.001) and showed strong convergent validity with a global health-specific question (r = 0.64, p < 0.001). The questionnaire exhibited high responsiveness (standardized response mean = -0.80) with minimal response shift effects (effect size = 0.30). The correlations with the audiometric parameters were weak (r = 0.11-0.16).

CONCLUSIONS: The German version of the COMQ-12 has satisfactory psychometric properties and can be recommended for assessing HRQoL in German-speaking population with COM. Its suitability for evaluating symptom-related quality of life is due to its symptom-focused design and high level of responsiveness. Its low response shift also makes it ideal for longitudinal monitoring of treatment outcomes.