CRS Questionnaire Validation Project
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe European Forum for Research and Education in Allergy and Airway Diseases
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Not capable of giving informed consent
No CRS
Recent sinus surgery (within the last three months)
Trial population
Adult patients, capable of giving consent, with certified CRS and no recent sinus surgery
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 6 months2
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.
Time frame
Through study completion, an average of 6 monthsSecondary outcomes
1
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.
Time frame
Through study completion, an average of 6 months2
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.
Time frame
Through study completion, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov