Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

NCT ID: NCT02879929

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 759 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-12-31

Brief 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.

Detailed 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.

Conditions

Rhinitis; Nasal Polyps

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

GUILLEMIN Francis, MD

PU-PH

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 21739093 (View on PubMed)

Other Identifiers

DyNaChron

Identifier Type: -

Identifier Source: org_study_id