The Sinonasal Outcome Test - 22, Validated for Danish Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bibi Lange, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01254916
First received: December 6, 2010
Last updated: May 6, 2012
Last verified: May 2012
  Purpose

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.


Condition
Chronic Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Sinonasal Outcome Test - 22, Validated for Danish Patients

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Reproducibility of Sinonasal Outcome test 22 [ Time Frame: From the time of fullfilling the first SNOT-22 to fullfilling the second SNOT-22 after 14 days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with chronic rhinosinusitis

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic rhinosinusitis diagnosed by a medical doctor

Criteria

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254916

Locations
Denmark
Department of Otorhinolaryngology, Odense University Hopsital
Odense, Denmark, DK-5000
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bibi Lange, MD, Ph.d.-student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01254916     History of Changes
Other Study ID Numbers: Danish SNOT 22
Study First Received: December 6, 2010
Last Updated: May 6, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Chronic Rhinosinusitis
Sinonasal Outcome test 22

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014