• Massimo Ralli, Nicola Quaranta, Andrea Canale, Christof Röösli, Claudia Milella, Valentina De Robertis, Giulia De Soccio, Antonio Greco, Giovanni Ralli, Roberto Albera, Marco de Vincentiis, Alexander M Huber, and David Bächinger.
• Department of Sense Organs, Sapienza University of Rome, Rome.
• Otol. Neurotol. 2019 Mar 1; 40 (3): 351-358.

ObjectiveThere are no instruments available to comprehensively assess health-related quality of life (HRQoL) in chronic otitis media (COM) in Italian-speaking countries. The Zurich chronic middle ear inventory (ZCMEI-21) is a well-established instrument for the assessment of HRQoL in COM. The objective of this study was to translate and cross-culturally adapt the ZCMEI-21 into Italian and validate this questionnaire for measuring HRQoL in patients with COM.Study DesignProspective multicenter study.SettingThree University hospitals (northern Italy, central Italy, southern Italy).PatientsAdult patients suffering from COM (n = 128).InterventionFollowing international guidelines, the ZCMEI-21 was translated into Italian (ZCMEI-21-It). Validation was performed by psychometric test statistics. Moreover, ZCMEI-21-It total and subscale scores were compared and correlated with 1) the scores of the original validation study, 2) to a question that directly addresses HRQoL, and 3) to the scores of the EQ-5D-5L, a generic questionnaire assessing HRQoL.ResultsFrom three study centers, a total of 128 patients with COM were included. Cronbach's α was 0.86 indicating a high reliability. Between the ZCMEI-21-It total score and the question that directly addresses HRQoL, we found a strong correlation (r = 0.62, p < 0.0001). Between the ZCMEI-21-It total score and the EQ-5D-5L scores, we expectedly found moderate correlations (descriptive system score: r = 0.39, p < 0.0001; visual analog scale: r = 0.30, p = 0.008).ConclusionWe translated the ZCMEI-21 questionnaire into Italian and validated the ZCMEI-21-It in a prospective multicenter study. The ZCMEI-21-It is the first instrument that comprehensively assesses relevant dimensions of HRQoL in Italian-speaking patients affected by COM.

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