An observational study in Rhinitis and Nasal Polyps, sponsored by Central Hospital, Nancy, France. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-16.
Sponsored by Central Hospital, Nancy, France · Observational
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.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 759 is above the median of 141 across 172 observational studies indexed under Rhinitis.
Browse Rhinitis studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients were consecutively recruited in 16 centers in rhinology outpatient clinics all over France.
Inclusion Criteria:Patients had to
Exclusion Criteria:
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
Time frame: 6 months
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
Time frame: 10 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France