Trials / Completed
CompletedNCT02879929
Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 759 (actual)
- Sponsor
- Central Hospital, Nancy, France · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2006-12-01
- Completion
- 2006-12-01
- First posted
- 2016-08-26
- Last updated
- 2017-08-16
Source: ClinicalTrials.gov record NCT02879929. Inclusion in this directory is not an endorsement.