Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR
NCT ID: NCT04423952
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-05-20
2020-05-20
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with chronic otitis media
Patients aged 7 to 15 years with chronic otitis media.
COMQ-12 questionnaire
Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.
Controls
Minors aged 7 to 15 years, with no and no history of chronic otitis.
COMQ-12 questionnaire
Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.
Interventions
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COMQ-12 questionnaire
Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
7 Years
15 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Françoise Denoyelle, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Necker-Enfants Malades
Paris, , France
Countries
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Other Identifiers
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2019-A00377-50
Identifier Type: OTHER
Identifier Source: secondary_id
APHP200195
Identifier Type: -
Identifier Source: org_study_id
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