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

Chronic Otitis Media Clinical Trial

— COMQ12-FR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04423952
• Other study ID #: APHP200195
• Secondary ID: 2019-A00377-50
• Status: Withdrawn
• Start date: July 2021
• Est. completion date: July 2022

Study information

• Verified date: November 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Otitis Media
• Otitis
• Otitis Media

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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