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

Withdrawn

• Conditions: Chronic Otitis Media
• Interventions: Other: COMQ-12 questionnaire

• Registration Number: NCT04423952
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-05-20
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-20
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic otitis media	COMQ-12 questionnaire	Patients aged 7 to 15 years with chronic otitis media.
Controls	COMQ-12 questionnaire	Minors aged 7 to 15 years, with no and no history of chronic otitis.

Primary Outcome Measures

Name	Time	Method
Consistency reliability test	1 year	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).
Reproducibility	1 year	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).
Principal components analysis	1 year	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).
Item-total Pearson correlation	1 year	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).

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France