The Sinonasal Outcome Test - 22, Validated for Danish Patients

Chronic Rhinosinusitis Clinical Trial

Official title:

The Sinonasal Outcome Test - 22, Validated for Danish Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254916
• Other study ID #: Danish SNOT 22
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: May 6, 2012
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2012
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in both incidence and prevalence. It calls into attention consensus about diagnosing, assessing symptoms and treatment of patients with CRS. Therefore a validated Danish measure of health-related quality of life in sinonasal disease is needed.

Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the SNOT-22.

Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the initial test and 0.92 in the retest. Pearson was 0.70 (p<0.001) revealing good correlation between the initial scores and the retests scores. Kappa was calculated for each item with a mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant difference in the subscales.

Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and researches as a patient-reported measure of outcome in sino-nasal disorders such as rhinosinusitis and nasal polyposis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

Inclusion Criteria: Persons diagnosed with Chronic Rhinosinusitis -

Exclusion Criteria: Change of treatment or acute change of symptoms due to common cold/influenza in the time between completing the test and the retest. If SNOT-score was very low. Persons who left before offered test or declined testing.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Locations

Country	Name	City	State
Denmark	Department of Otorhinolaryngology, Odense University Hopsital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of Sinonasal Outcome test 22		From the time of fullfilling the first SNOT-22 to fullfilling the second SNOT-22 after 14 days	No