CRS Questionnaire Validation Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 42
- 主要终点
- Validation of a new questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Not capable of giving informed consent
- •Recent sinus surgery (within the last three months)
结局指标
主要结局
Validation of a new questionnaire
时间窗: Through study completion, an average of 6 months
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.
Evaluation of the results
时间窗: Through study completion, an average of 6 months
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.
次要结局
- Validation of a new questionnaire(Through study completion, an average of 6 months)
- Evaluation of the results(Through study completion, an average of 6 months)