The Sinonasal Outcome Test - 22, Validated for Danish Patients
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 6, 2010 |
| Last Updated Date | May 6, 2012 |
| Start Date ICMJE | October 2008 |
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE |
Reproducibility of Sinonasal Outcome test 22 |
| Change History | Complete list of historical versions of study NCT01254916 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | The Sinonasal Outcome Test - 22, Validated for Danish Patients |
| Official Title ICMJE | The Sinonasal Outcome Test - 22, Validated for Danish Patients |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Patients with chronic rhinosinusitis diagnosed by a medical doctor |
| Condition ICMJE | Chronic Rhinosinusitis |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Patients with chronic rhinosinusitis |
| Publications * | Lange B, Thilsing T, Al-kalemji A, Baelum J, Martinussen T, Kjeldsen A. The Sino-Nasal Outcome Test 22 validated for Danish patients. Dan Med Bull. 2011 Feb;58(2):A4235. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 44 |
| Completion Date | March 2009 |
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | 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. - |
| Gender | Both |
| Ages | 15 Years to 75 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Denmark |
| Administrative Information | |
| NCT Number ICMJE | NCT01254916 |
| Other Study ID Numbers ICMJE | Danish SNOT 22 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Bibi Lange, Odense University Hospital |
| Study Sponsor ICMJE | Odense University Hospital |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Odense University Hospital |
| Verification Date | May 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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