Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

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.

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Key information

Conditions

Rhinitis Infections Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Development of the DyNaChron questionnaire for chronic nasal dysfunction

Time frame: 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 outcomes

Validation of the DyNaChron questionnaire for chronic nasal dysfunction

Time frame: 10 months

to test the validity of the new instrument developped in a large representative sample of patients attending outpatient rhinology clinics

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: DyNaChron

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Aug 26, 2016
Registry last updated: Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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