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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.
The objectives of this study are as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| Validation of a new questionnaire | Validation of a questionnaire based on similar questionnaires already approved for use in other airway diseases. The aim to measure the current perceived status of a patient with chronic rhinosinusitis in terms of control and severity. A new questionnaire will be tested and compared with current tools. For this purpose, a set of questionnaires has been developed including the EPOS criteria for chronic rhinosinusitis, the SNOT-22, the patient global assessment tool and the VAS scores, among others. All these questionnaires will be completed by the patient at visit 1 and the results will be analysed once the recruitment target of 1,000 patients has been reached. No second patient participation is required. | Through study completion, an average of 6 months |
| Evaluation of the results | Evaluation of the results of this questionnaire in comparison with other tools currently available. Once the target of recruiting 1000 patients has been reached, the results will be statistically analysed. Parallels will be drawn between the responses obtained by the usual means and those captured in the questionnaires to be validated. It is expected that, in all cases, the degree of control and severity represented in the questionnaires to be validated will conform to the EPOS criteria and to the results of the questionnaires usually used. The results will be compared for each of the new questionnaires in general and separately by language. The ultimate goal is to validate what will become the diagnostic gold standard for chronic rhinosinusitis. | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of a new questionnaire | Validation of a questionnaire based on feedback collected from patients with CRS where they expressed which are the symptoms that most afflict them or are most present, related to their disease. The aim to measure the current perceived status of a patient with chronic rhinosinusitis in terms of control and severity. A new questionnaire will be tested and compared with current tools. For this purpose, a set of questionnaires has been developed including the EPOS criteria for chronic rhinosinusitis, the SNOT-22, the patient global assessment tool and the VAS scores, among others. All these questionnaires will be completed by the patient at visit 1 and the results will be analysed once the recruitment target of 1,000 patients has been reached. No second patient participation is required. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients, capable of giving consent, with certified CRS and no recent sinus surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Santa Monica Medical Center | Recruiting | Santa Monica | California | 90401 | United States |
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| Through study completion, an average of 6 months |
| Evaluation of the results | Evaluation of the results of this questionnaire in comparison with other tools currently available. Once the target of recruiting 1000 patients has been reached, the results will be statistically analysed. Parallels will be drawn between the responses obtained by the usual means and those captured in the questionnaires to be validated. It is expected that, in all cases, the degree of control and severity represented in the questionnaires to be validated will conform to the EPOS criteria and to the results of the questionnaires usually used. | Through study completion, an average of 6 months |
| Northwestern University Feinberg School of Medicine | Recruiting | Chicago | Illinois | 60208 | United States |
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| Brigham Sinus Center at Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Eastern Virginia Medical School | Recruiting | Virginia City | Virginia | 23507 | United States |
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| UZ Gent | Not yet recruiting | Ghent | Belgium |
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| UZ Leuven | Recruiting | Leuven | Belgium |
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| St. Michael's Hospital | Recruiting | Toronto | Canada |
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| Univ of Copenhagen | Recruiting | Copenhagen | Denmark |
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| HNO-Klinik, Universitätsklinikum Düsseldorf | Not yet recruiting | Düsseldorf | Germany |
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| Univ Munich | Not yet recruiting | Munich | Germany |
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| University General Hospital of Heraklion | Recruiting | Heraklion | Greece |
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| U. Aristotle | Recruiting | Thessaloniki | Greece |
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| Univ Hospital Roma | Recruiting | Roma | Italy |
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| Univ Amsterdam | Not yet recruiting | Amsterdam | Netherlands |
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| Alrijne Zorggroep | Recruiting | Leiden | Netherlands |
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| University of Oradea | Recruiting | Oradea | Romania |
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| Ahmed Alkhadi Hospital | Recruiting | Durban | South Africa |
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| Hospital Clínico Universitario de Compostela | Recruiting | A Coruña | Spain |
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| Hospital Clinic Barcelona | Recruiting | Barcelona | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
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| Hospital de La Línea de La Concepción | Recruiting | Cadiz | Spain |
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| Hospital Universitario Jerez de La Frontera | Recruiting | Cadiz | Spain |
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| Hospital Universitario Puerta del Mar | Recruiting | Cadiz | Spain |
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| Hospital Universitario Puerto Real | Recruiting | Cadiz | Spain |
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| Hospital Universitario Fuenlabrada | Recruiting | Madrid | Spain |
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| Hospital Universitario Infanta Elena, Madrid y Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Spain |
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| Hospital del Bierzo | Recruiting | Ponferrada | Spain |
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| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Spain |
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| Hospital Universitario Virgen Macarena | Recruiting | Seville | Spain |
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| Hospital General Universitario de Valencia | Recruiting | Valencia | Spain |
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