Clinical trial NCT04117646: Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire
Official title: Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis
Keywords: Chronic rhinosinusitis of children
Sinus and nasal quality of life survey questionnaire (SN-5)
Translation in French of the SN-5
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 89
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
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: 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.

Eligibility criteria: 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

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: AP-HP, Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas Leboulanger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: