RESUMO
OBJECTIVES: To translate and validate the Zurich Chronic Middle Ear Inventory (ZCMEI-21) for the English language in order to provide an English instrument to assess health-related quality of life in chronic otitis media (COM). DESIGN: Pilot translation study including cognitive debriefings, prospective multicentre cross-sectional psychometric validation study. SETTING: Four tertiary referral centres in three different English-speaking countries (UK, USA and Australia). PARTICIPANTS: Adult patients suffering from COM. MAIN OUTCOME MEASURES: The English translation of the ZCMEI-21 (ZCMEI-21-E) and the five-level version of the EQ-5D questionnaire. The EQ-5D, which constitutes a generic measure of health-related quality of life, consists of a descriptive system score and a visual analogue scale. Statistical outcomes included single-item descriptive statistics, internal consistency (Cronbach's α) as an indicator of reliability, as well as construct validity. RESULTS: A total of 124 patients suffering from COM were included. The mean age was 50.1 years (SD 16.9 years), and 72 (58.1%) were males. The Cronbach's α of the ZCMEI-21-E was 0.91, suggesting an excellent internal consistency. The Spearman's correlation coefficient of the ZCMEI-21-E total score was 0.55 (P < 0.0001) for convergent construct validity with EQ-5D descriptive system score and 0.57 (P < 0.0001) with the EQ-5D visual analogue scale. CONCLUSIONS: The ZCMEI-21-E is a new validated questionnaire that provides clinicians with a short, comprehensive and reliable instrument to quantify health-related quality of life in patients suffering from COM. The ZCMEI-21-E may be of use in clinical routine as well as in outcome research and monitoring.