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Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

C

Central Hospital, Nancy, France

Status

Completed

Conditions

Nasal Polyps
Rhinitis

Study type

Observational

Funder types

Other

Identifiers

NCT02879929
DyNaChron

Details and patient eligibility

About

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.

Full 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.

Enrollment

759 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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