Maesschalck Thibault De, Quatre Raphaele, Horoi Mihaela, Rodriguez Alexandra, Sagnet Pierre, Röösli Christof, Huber Alexander, Voruz François, Senn Pascal, Schmerber Sebastian, Bächinger David
Service of Otorhinolaryngology, Head and Neck Surgery, Department of clinical Neurosciences, University Hospital of Geneva, Geneva, Switzerland.
Center for Oto-Rhino-Laryngology - Maxillo-Facial and Head and Neck Surgery, Hôpital de la Tour, La Tour Medical Group, Meyrin, Switzerland.
Eur Arch Otorhinolaryngol. 2025 May 24. doi: 10.1007/s00405-025-09447-0.
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.
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.
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).
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.
慢性中耳炎（COM）严重影响患者的生活质量，但现有的评估工具可能无法完全捕捉其多维度影响。苏黎世慢性中耳量表（ZCMEI - 21）已成为评估COM患者健康相关生活质量（HRQoL）的一种全面且国际认可的测量工具。然而，目前缺乏经过验证的法语版ZCMEI - 21，因此需要进行翻译和验证，以便在说法语的人群中使用。
进行了一项前瞻性多中心研究，将ZCMEI - 21翻译成法语（ZCMEI - 21 - Fr）并进行验证。翻译过程遵循既定指南，包括专业翻译、认知反馈和回译。验证过程涉及在多个中心向说法语的COM患者同时发放ZCMEI - 21 - Fr和通用的EQ - 5D问卷。使用心理测量统计方法评估内部一致性、可靠性和有效性。
该研究共纳入102名说法语的COM患者。ZCMEI - 21 - Fr在所有子量表上均表现出出色的内部一致性（Cronbach's α = 0.89）和可靠性。ZCMEI - 21 - Fr总分与直接评估HRQoL的一个问题高度相关（r = 0.59，p < 0.0001）。与EQ - 5D观察到中度相关性（r = 0.41，p < 0.0001）。
ZCMEI - 21 - Fr为评估说法语患者中COM的心理社会影响提供了一个有价值的工具。它对HRQoL维度的全面覆盖，包括心理影响，使其有别于现有工具。经过验证的法语版的可用性提高了COM患者HRQoL评估在国际范围内的标准化程度。
