Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

Completed

• Conditions: Rhinitis; Nasal Polyps

• Registration Number: NCT02879929
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-13
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 759

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of the DyNaChron questionnaire for chronic nasal dysfunction	6 months	to develop a self-report questionnaire to assess nose and sinus functional symptoms together with their consequences for physical and psychosocial areas

Secondary Outcome Measures

Name	Time	Method
Validation of the DyNaChron questionnaire for chronic nasal dysfunction	10 months	to test the validity of the new instrument developped in a large representative sample of patients attending outpatient rhinology clinics