Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02879929

Acronym

DyNaChron

Enrollment

759

Registered

2016-08-26

Start date

2005-10-31

Completion date

2006-12-31

Last updated

2017-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Polyps, Rhinitis

Keywords

chronic nasal dysfunction, Quality of life, measurement, self-reporting questionnaire, development, validation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results