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Cross-cultural adaption and validation of the Chronic Otitis Media Questionnaire 12 (COMQ-12) in the Italian language

  • Otology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Purpose

The evaluation of Health-Related Quality of Life (HRQoL) in patients with chronic otitis media COM has gained attention over the past years and several questionnaires have been developed to evaluate it in affected patients. The Chronic Otitis Media Questionnaire 12 (COMQ-12) is a widely used disease-specific tool that evaluates the severity of symptoms, the specific impact on work and lifestyle, the effects on the health service, and general impact of the disease in patients with COM. The COMQ-12 questionnaire has been translated and validated into different languages; however, an Italian version is not yet available. The aim of this original study was to translate the COMQ-12 questionnaire into the Italian language and validate this new Italian language version in Italian-speaking patients with COM.

Methods

The COMQ-12 was translated into Italian (COMQ-12-It) following international guidelines. Validation was performed comparing and correlating COMQ-12-It with (1) a question that addresses HRQoL, and (2) the results of a generic questionnaire assessing HRQoL, namely the EQ-5D-5L questionnaire.

Results

Forty-eight patients with COM were included in the study. Cronbach’s alpha was 0.80 indicating a high reliability. There was a strong positive correlation between the question that directly addressed HRQoL and total score (correlation coefficient = 0.62), while the regression analysis between total score of COMQ-12-It and EQ-5D-5L showed a positive relation but only a weak positive correlation (correlation coefficient 0.36).

Conclusions

Our study showed evidence that the Italian version of the COMQ-12 questionnaire is a valid and reliable tool to evaluate HRQoL in Italian-speaking patients with COM.

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Acknowledgements

The authors wish to thank the translation experts who performed the two forward translations and in the back translation of the COMQ-12 questionnaire (Dana Linn Damon, USA; Michael Massing, Canada; Jay Joseph Abedin, Ireland).

Funding

The authors declare that they have no sources of funding.

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Authors and Affiliations

  1. Otolaryngology Unit, Department of BMS, Neuroscience and Sensory Organs, University of Bari, Bari, Italy

    Nicola Quaranta, Valentina De Robertis, Marco Pontrelli, Maria Luisa Fiorella & Vito Pontillo

  2. Department of Sense Organs, Sapienza University of Rome, Viale del Policlinico 155, 00186, Rome, Italy

    Claudia Milella, Antonio Greco & Massimo Ralli

  3. Department of Oral and Maxillofacial Surgery, Sapienza University of Rome, Rome, Italy

    Marco de Vincentiis

  4. Department of Otolaryngology-Head and Neck Surgery, Norfolk and Norwich University Hospital, Norwich, UK

    Jonathan S. Phillips

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  1. Nicola Quaranta
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Correspondence to Massimo Ralli.

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Research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee of the University of Bari (2018) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Quaranta, N., De Robertis, V., Milella, C. et al. Cross-cultural adaption and validation of the Chronic Otitis Media Questionnaire 12 (COMQ-12) in the Italian language. Eur Arch Otorhinolaryngol 276, 3027–3033 (2019). https://doi.org/10.1007/s00405-019-05591-6

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