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

Chronic Rhinosinusitis Clinical Trial

— SN5-FR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117646
• Other study ID #: APHP190791
• Secondary ID: ID RCB : 2019-A0
• Status: Completed
• Start date: April 6, 2020
• Est. completion date: June 11, 2020

Study information

• Verified date: January 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

Other:
• Sinus and nasal quality of life survey questionnaire (SN-5)
Subjects respond to the translated questionnaire twice at 15 days apart.

Locations

Country	Name	City	State
France	AP-HP, Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Gargula S, Luscan R, Drummond D, Denoyelle F, Couloigner V, Leboulanger N, Simon F. French translation and validation of the Sinus and Nasal Quality of Life Survey (SN-5) in children. Int J Pediatr Otorhinolaryngol. 2021 Jun;145:110706. doi: 10.1016/j.ijp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility	Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.	1 year
Primary	Consistency reliability test	Measure of efficiency. Comparison of questionnaires completed by patients and controls.	1 year
Primary	Item-total Pearson correlation	Measure of efficiency. Comparison of questionnaires completed by patients and controls.	1 year
Primary	Principal components analysis	Measure of efficiency. Comparison of questionnaires completed by patients and controls.	1 year