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临床试验/NCT01254916
NCT01254916已完成不适用

The Sinonasal Outcome Test - 22, Validated for Danish Patients

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Reproducibility of Sinonasal Outcome test 22

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons diagnosed with Chronic Rhinosinusitis -

排除标准

  • 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.

结局指标

主要结局

Reproducibility of Sinonasal Outcome test 22

时间窗: From the time of fullfilling the first SNOT-22 to fullfilling the second SNOT-22 after 14 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bibi Lange

MD, Ph.d.-student

Odense University Hospital

研究点 (1)

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