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Background  Evaluation of health-related quality of life (HRQoL) is considered an important aspect of clinical assessment and health research. Chronic Otitis Media (COM) is related to the quality of life deterioration subsequent to COM symptoms, social communication impairments, and lower work performance. However, there is no reliable information regarding the impact of this disease on health and quality of life in many resource-poor countries. Therefore, we translated into Spanish the Chronic Otitis Media Questionnaire-12 (COMQ-12) for the evaluation of HRQoL of Chronic Otitis Media (COM) in adult patients. Also, we assessed the psychometric properties of the Spanish version of the questionnaire.    Methods  Two otology referral centers in Bogotá, Colombia were included. The Spanish version of COMQ-12 was applied twice to 200 adult patients with confirmed COM diagnosis and 31 healthy controls to perform the validation process and assess the internal consistency of this questionnaire. Psychometric characteristics (internal consistency, test–retest reliability, and construct validity) of the COMQ-12 were assessed. Exploratory Factor Analysis and Confirmatory Factor Analysis were conducted via structural equation modeling to test the questionnaire’s structure.    Results  The Spanish version of the COMQ-12 showed good internal consistency (Cronbach’s Alpha: 0.86, McDonald’s Omega: 0.89). Coefficients corresponding to Lin’s Concordance test and test–retest reliability were 0.95 and 0.83 respectively. Correlation between the Visual Analogue Scale (VAS) and the COMQ-12 was 0.68 (95% CI 0.59–0.75,  p  value < 0.001). Factor analysis of the Spanish version of the COMQ-12 indicated a questionnaire structure with three domains: smelly discharge related symptoms; hearing loss related symptoms; and impact on work, lifestyle, and health services.    Conclusion  This Spanish version of the COMQ-12 showed high reliability and high internal consistency. This questionnaire can be used as an objective clinical tool to assess the HRQoL of patients who have a COM diagnosis.    Trial registration  Hospital Universitario Fundación Santa Fe, Ethical Committee Registration ID: CCEI-8807-2018. Hospital de San José, Ethical Committee: Record number 500, DI-I-0632-18.

Validation of a Spanish version of the health-related quality of life (HRQoL) measure for Chronic Otitis Media (COMQ-12)