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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Otitis Media
• Intervention / Treatment: Other: COMQ-12 questionnaire

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 Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic otitis media; Patients aged 7 to 15 years with chronic otitis media.	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.; Other Names: Patient questionnaire
Controls; Minors aged 7 to 15 years, with no and no history of chronic otitis.	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.; Other Names: Patient questionnaire

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Françoise Denoyelle, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Chronic otitis media in children; Standardized quality of life measurement questionnaire
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: APHP200195; 2019-A00377-50 (Other Identifier: ID RCB (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No