CRS Questionnaire Validation Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Canada, Denmark, Germany +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Primary outcome measures
- Validation of a new questionnaire [Time frame: Through study completion, an average of 6 months]
- Evaluation of the results [Time frame: Through study completion, an average of 6 months]
Secondary outcome measures (2)
- Validation of a new questionnaire [Time frame: Through study completion, an average of 6 months]
- Evaluation of the results [Time frame: Through study completion, an average of 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Spain · 14 centers
- Hospital Clínico Universitario de Compostela — A Coruña
- Hospital Clinic Barcelona — Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona
- Hospital de La Línea de La Concepción — Cadiz
- Hospital Universitario Jerez de La Frontera — Cadiz
- Hospital Universitario Puerta del Mar — Cadiz
- Hospital Universitario Puerto Real — Cadiz
- Hospital Universitario Fuenlabrada — Madrid
- … and 6 more centers
United States · 5 centers
- UCLA Santa Monica Medical Center — Santa Monica
- Northwestern University Feinberg School of Medicine — Chicago
- Brigham Sinus Center at Brigham and Women's Hospital — Boston
- Thomas Jefferson University Hospital — Philadelphia
- Eastern Virginia Medical School — Virginia City
Belgium · 2 centers
- UZ Gent — Ghent
- UZ Leuven — Leuven
Germany · 2 centers
- HNO-Klinik, Universitätsklinikum Düsseldorf — Düsseldorf
- Univ Munich — Munich
Greece · 2 centers
- University General Hospital of Heraklion — Heraklion
- U. Aristotle — Thessaloniki
Netherlands · 2 centers
- Univ Amsterdam — Amsterdam
- Alrijne Zorggroep — Leiden
Canada · 1 center
- St. Michael's Hospital — Toronto
Denmark · 1 center
- Univ of Copenhagen — Copenhagen
Italy · 1 center
- Univ Hospital Roma — Roma
Romania · 1 center
- University of Oradea — Oradea
South Africa · 1 center
- Ahmed Alkhadi Hospital — Durban
Identifiers
NCT: NCT06970977 · S68027