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).

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.