CRS Questionnaire Validation Project

The European Forum for Research and Education in Allergy and Airway Diseases

Status: Enrolling

Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Study type: Observational

Funder types: Other

Identifiers

NCT06970977

S68027

Details and patient eligibility

About

The 'CRS validation project' consists of a joint effort of 32 medical centers in Europe, the USA, and South Africa to carry out the validation of 2 novel questionnaires designated to measure self-perceived severity and control of Chronic Rhinosinusitis (with or without nasal polyps).

This study will validate translated versions of the same set of questionnaires simultaneously in the centers involved after recruiting a total of 1000 patients, while data collection, statistical analysis, and creation of the study report will be carried out by the statistical department of the University of Leuven.

Patients will be recruited from the regular ENT practice of their hospital to minimize the complexity of the study.

Full description

The objectives of this study are as follows:

• Validation of two new questionnaires with the aim of measuring the current perceived condition of a patient with chronic rhinosinusitis in terms of control and severity.
• Validation of these questionnaires in routine medical settings.
• Evaluation of the results of these questionnaires in comparison with other tools currently available.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient capable of giving informed consent
• Diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines
• No recent sinus surgery (within the last three months)

Exclusion criteria

• Not capable of giving informed consent
• No CRS
• Recent sinus surgery (within the last three months)