Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

Rhinitis Clinical Trial

— DyNaChron  

Official title:

Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879929
• Other study ID #: DyNaChron
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: August 13, 2017
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: August 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Nasal symptoms are the main elements that lead to a therapeutic decision and allow for evaluating treatment effects or natural evolution. Despite availability of several questionnaires with good measurement qualities, no systematic assessment takes into account the specific physical and psychosocial consequences of each of the six main nasal symptoms, independently of the disease. The study proposed to measure these symptoms with the use of a selfreport questionnaire and to test the validity of the questionnaire in a large representative sample of patients attending outpatient rhinologic clinics.

Description:

The study was conducted in two parts: (1) expert-based development and testing of the face validity of a questionnaire in French; and (2) validity testing, including construct validity by factor analysis, reproducibility by intraclass correlation coefficient (ICC) and Bland and Altman plots, and sensitivity to change by standardized response means, on a large sample of patients in a prospective multicenter study. DyNaChron, a questionnaire with 78 items divided into six domains and exploring both the physical and psychosocial repercussions of CND, was developed. In total, 759 patients completed the questionnaire at a first visit to a clinic, and 539 again 19.5 days later, on average.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:Patients had to

• be older than 18 years

• have nasal or sinus dysfunction for more than 3 months

• be able to understand and read theFrench language.

Exclusion Criteria:

• nasal or sinus tumor or Rendu-Osler disease,

• patients were under immediate post-operative care

Related Conditions & MeSH terms

• Nasal Polyps
• Rhinitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (1)

Kacha S, Guillemin F, Jankowski R. Development and validity of the DyNaChron questionnaire for chronic nasal dysfunction. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):143-53. doi: 10.1007/s00405-011-1690-z. Epub 2011 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of the DyNaChron questionnaire for chronic nasal dysfunction	to develop a self-report questionnaire to assess nose and sinus functional symptoms together with their consequences for physical and psychosocial areas	6 months
Secondary	Validation of the DyNaChron questionnaire for chronic nasal dysfunction	to test the validity of the new instrument developped in a large representative sample of patients attending outpatient rhinology clinics	10 months