Cross-cultural Adaption and Validation of the Zurich Chronic Middle Ear Inventory Translated Into Italian (ZCMEI-21-It)-a Prospective Multicenter Study.

Abstract

OBJECTIVE\nThere 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.\n\n\nSTUDY DESIGN\nProspective multicenter study.\n\n\nSETTING\nThree University hospitals (northern Italy, central Italy, southern Italy).\n\n\nPATIENTS\nAdult patients suffering from COM (n\u200a=\u200a128).\n\n\nINTERVENTION\nFollowing 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.\n\n\nRESULTS\nFrom 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\u200a=\u200a0.62, p\u200a<\u200a0.0001). Between the ZCMEI-21-It total score and the EQ-5D-5L scores, we expectedly found moderate correlations (descriptive system score: r\u200a=\u200a0.39, p\u200a<\u200a0.0001; visual analog scale: r\u200a=\u200a0.30, p\u200a=\u200a0.008).\n\n\nCONCLUSION\nWe 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.