European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
A novel instrument for assessing health-related quality of life in French patients: translation and multi-centre validation of the Zurich chronic middle ear inventory (ZCMEI-21-Fr).
СтатьяМногоцентровое исследованиеВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Maesschalck Thibault De, Quatre Raphaele, Horoi Mihaela, Rodriguez Alexandra, Sagnet Pierre, Röösli Christof, Huber Alexander, Voruz François, Senn Pascal, Schmerber Sebastian, Bächinger David
Аннотация
INTRODUCTION: Chronic otitis media (COM) significantly impacts the quality of life of patients, yet existing assessment tools may not fully capture its multidimensional effects. The Zurich Chronic Middle Ear Inventory (ZCMEI-21) has emerged as a comprehensive and internationally recognized measure for evaluating health-related quality of life (HRQoL) in COM patients. However, a validated French version of the ZCMEI-21 is lacking, necessitating translation and validation to facilitate its use in French-speaking populations.
METHODS: A prospective multicentre study was conducted to translate and validate the ZCMEI-21 into French (ZCMEI-21-Fr). The translation process followed established guidelines, including professional translation, cognitive debriefing, and back-translation. The validation process involved administering the ZCMEI-21-Fr together with the generic EQ-5D questionnaire to French-speaking COM patients across multiple centers. Internal consistency, reliability, and validity were assessed using psychometric statistical methods.
RESULTS: A total of 102 French-speaking COM patients were included in the study. The ZCMEI-21-Fr demonstrated excellent internal consistency (Cronbach's α = 0.89) and reliability across all subscales. Total ZCMEI-21-Fr scores correlated strongly with a question directly assessing HRQoL (r = 0.59, p < 0.0001). Moderate correlations were observed with the EQ-5D (r = 0.41, p < 0.0001).
DISCUSSION: The ZCMEI-21-Fr offers a valuable tool for assessing the psychosocial impact of COM in French-speaking patients. Its comprehensive coverage of HRQoL dimensions, including psychological effects, distinguishes it from existing instruments. The availability of a validated French version enhances the standardization of HRQoL assessment in COM patients on an international scale.
METHODS: A prospective multicentre study was conducted to translate and validate the ZCMEI-21 into French (ZCMEI-21-Fr). The translation process followed established guidelines, including professional translation, cognitive debriefing, and back-translation. The validation process involved administering the ZCMEI-21-Fr together with the generic EQ-5D questionnaire to French-speaking COM patients across multiple centers. Internal consistency, reliability, and validity were assessed using psychometric statistical methods.
RESULTS: A total of 102 French-speaking COM patients were included in the study. The ZCMEI-21-Fr demonstrated excellent internal consistency (Cronbach's α = 0.89) and reliability across all subscales. Total ZCMEI-21-Fr scores correlated strongly with a question directly assessing HRQoL (r = 0.59, p < 0.0001). Moderate correlations were observed with the EQ-5D (r = 0.41, p < 0.0001).
DISCUSSION: The ZCMEI-21-Fr offers a valuable tool for assessing the psychosocial impact of COM in French-speaking patients. Its comprehensive coverage of HRQoL dimensions, including psychological effects, distinguishes it from existing instruments. The availability of a validated French version enhances the standardization of HRQoL assessment in COM patients on an international scale.