Clinical trial NCT04423952: Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR
Official title: Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Otitis Media
Keywords: Chronic otitis media in children
Standardized quality of life measurement questionnaire
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reproducibility
timeFrame: 1 year
measure: Consistency reliability test
timeFrame: 1 year
measure: Item-total Pearson correlation
timeFrame: 1 year
measure: Principal components analysis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Françoise Denoyelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: