Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR

Study Overview
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Brief Summary
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The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs. The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is gladly recurrent. The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments. The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media. The objective of this study is to translate and validate the test in French in children.

Detailed Description
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The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs. The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is often recurrent. The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments. The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media. The original version of the COMQ12 questionnaire, in English, was developed by Phillips et al.. The construction of this questionnaire was based on three other questionnaires : the Chronic Ear Survey (CES), the Chronic Otitis Media Outcome-15 (COMOT-15), and the Chronic Otitis Media-5 (COM-5). The initial validation of the English version of Phillips et al. was evaluated with an alpha value of Cronbach to 0.889, which shows high internal consistency and would allow its use in several reputed international centers of otology. The objective of this study is to translate and validate the test in French in children.

Official Title
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Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR

Conditions
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Chronic Otitis Media

Intervention / Treatment
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* Other: COMQ-12 questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minors aged 7 to 15 years (inclusive) Patients with chronic otitis media, united or bilateral Controls: subjects without chronic otitis media or any other pathology of the ear at the time of Inclusion or in background holders of parental authority not opposed to participation in the study Exclusion Criteria: - Non-comprehension of french

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic otitis media<br>Patients aged 7 to 15 years with chronic otitis media. | Other: COMQ-12 questionnaire<br>* Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.<br>* Other names: Patient questionnaire;|
| Controls<br>Minors aged 7 to 15 years, with no and no history of chronic otitis. | Other: COMQ-12 questionnaire<br>* Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.<br>* Other names: Patient questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility | Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible). | 1 year | 
| Consistency reliability test | Measure of efficiency. Comparison of questionnaires completed by patients and controls. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible). | 1 year | 
| Item-total Pearson correlation | Measure of efficiency. Comparison of questionnaires completed by patients and controls. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible). | 1 year | 
| Principal components analysis | Measure of efficiency. Comparison of questionnaires completed by patients and controls. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic otitis media in children, Standardized quality of life measurement questionnaire