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OpenTrials
Completed

NCT Number: NCT01254916

The Sinonasal Outcome Test - 22, Validated for Danish Patients

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.

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Otorhinolaryngology, Odense University Hopsital

Odense, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 7, 2010
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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