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Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire

Completed
Conditions
Chronic Rhinosinusitis
Interventions
Other: Sinus and nasal quality of life survey questionnaire (SN-5)
Registration Number
NCT04117646
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Brief Summary

A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.

The objective of the study is to validate the translation of the SN-5 questionnaire in French.

Detailed Description

Chronic rhinosinusitis is a common pathology that entrains significant medical consumption. The prevalence of chronic rhinosinusitis in children is estimated to be 7.6%. Cardinal symptoms include nasal congestion, purulent rhinorrhea, facial pain, and persistent daytime cough. All these nasal symptoms often have an impact on the quality of life. The main objective of medical treatment is to improve this quality of life.

The treatment of chronic rhinosinusitis is mainly medical and includes nose washes with physiological serum, topical or general corticosteroid treatment or antibiotics. Surgical treatments such as adenoidectomy or endonasal functional surgery are reserved for medical treatment failures. According to a European consensus paper of 2012, the surgical strategy of the chronic rhinosinusitis of the child must start with a adenoidectomy with physiological serum washes, and then secondarily a endonasal functional surgery.

The ability of quality of life questionnaires to measure subjective symptoms over a certain length of time can help in the medical decision by determining the benefit of taking care. A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.

The objective of the study is to validate the translation of the SN-5 questionnaire in French.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
89
Inclusion Criteria
  • Non-opposition of the holders of parental authority and the subject to participation in the study
  • Subjects between 2 and 12 years of age Patients : - Patients followed in consultation at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery for chronic rhinosinusitis (rhinosinusitis more than 12 weeks)

Controls :

  • Subject without chronic rhinosinusitis at the time of inclusion and without chronic rhinitis history
Exclusion Criteria

French language not spoken by parents

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PatientsSinus and nasal quality of life survey questionnaire (SN-5)Patients of 2 and 12 years of age with chronic rhinosinusitis.
ControlsSinus and nasal quality of life survey questionnaire (SN-5)Subjects of 2 and 12 years of age without chronic rhinosinusitis.
Primary Outcome Measures
NameTimeMethod
Item-total Pearson correlation1 year

Measure of efficiency. Comparison of questionnaires completed by patients and controls.

Consistency reliability test1 year

Measure of efficiency. Comparison of questionnaires completed by patients and controls.

Reproducibility1 year

Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.

Principal components analysis1 year

Measure of efficiency. Comparison of questionnaires completed by patients and controls.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

AP-HP, Hôpital Necker-Enfants Malades

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Paris, France

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