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临床试验/NCT04388085
NCT04388085已完成不适用

Validity, Reliability and Responsiveness of King's Sarcoidosis Questionnaire in a Danish Population

University of Aarhus1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Internal consistency

研究概览

简要总结

The King's Sarcoidosis Questionnaire (KSQ) is a brief questionnaire assessing health status in patients with sarcoidosis. The KSQ was previously validated in English German and Dutch.

KSQ will be translated into Danish and validated in a Danish sarcoidosis population.

详细描述

KSQ will be linguistic validated according to existing guidelines. Consecutive patients with sarcoidosis will complete KSQ and other health questionnaires at baseline, after two weeks and 12 months. Concurrent validity, reliability, and responsiveness will be assessed.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with sarcoidosis
  • Signed informed consent

排除标准

  • Inability or unwillingness to adhere to the study
  • Inability to give informed consent

结局指标

主要结局

Internal consistency

时间窗: At baseline

Internal consistency, the interrelatedness of the items in the questionnaire, will be estimated by calculating Cronbach's α for each domain.

Responsiveness

时间窗: 1 year from baseline

Responsiveness: The ability to detect changes over time was assessed by measuring changes in KSQ over 12 months and correlating to changes in other questionnaires

Test-retest reliability

时间窗: At baseline

Test-retest reliability will be evaluated by Intraclass correlation coefficients (ICC) and Bland- Altman plots comparing KSQ scores at baseline and at 14 days in stable patients

Concurrent validity

时间窗: At baseline

Concurrent validity was assessed by measuring the correlation of KSQ to other questionnaires

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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