CRS Questionnaire Validation Project

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Validation of a new questionnaire [Срок оценки: Through study completion, an average of 6 months]
• Evaluation of the results [Срок оценки: Through study completion, an average of 6 months]

Вторичные конечные точки (2)

• Validation of a new questionnaire [Срок оценки: Through study completion, an average of 6 months]
• Evaluation of the results [Срок оценки: Through study completion, an average of 6 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 14 центров

• 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
• … и ещё 6 центров

США · 5 центров

• 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

Бельгия · 2 центра

• UZ Gent — Ghent
• UZ Leuven — Leuven

Германия · 2 центра

• HNO-Klinik, Universitätsklinikum Düsseldorf — Düsseldorf
• Univ Munich — Munich

Греция · 2 центра

• University General Hospital of Heraklion — Heraklion
• U. Aristotle — Thessaloniki

Нидерланды · 2 центра

• Univ Amsterdam — Amsterdam
• Alrijne Zorggroep — Leiden

Канада · 1 центр

• St. Michael's Hospital — Toronto

Дания · 1 центр

• Univ of Copenhagen — Copenhagen

Италия · 1 центр

• Univ Hospital Roma — Roma

Румыния · 1 центр

• University of Oradea — Oradea

ЮАР · 1 центр

• Ahmed Alkhadi Hospital — Durban

Идентификаторы

NCT: NCT06970977 · S68027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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