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

NCT04423952 | Withdrawn

• 2 other identifiers: APHP2001952019-A00377-50
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Otitis Media

Keywords

Chronic otitis media in children; Standardized quality of life measurement questionnaire

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Patients with chronic otitis media

Patients aged 7 to 15 years with chronic otitis media.

Other: COMQ-12 questionnaire

Controls

Minors aged 7 to 15 years, with no and no history of chronic otitis.

Other: COMQ-12 questionnaire

Interventions

COMQ-12 questionnaire OTHER

Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.

Also known as: Patient questionnaire

Controls; Patients with chronic otitis media

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Minors aged 7 to 15 years (inclusive)
• Patients with chronic otitis media, united or bilateral
• holders of parental authority not opposed to participation in the study

You may not qualify if:

• \- Non-comprehension of french

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Interventions

Patient Health Questionnaire

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Françoise Denoyelle, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: May 20, 2020
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: September 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)