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临床试验/NCT04730128
NCT04730128已完成不适用

Translation and Validation of the Hirschsprung and Anorectal Malformation Quality of Life (HAQL) Questionnaire in a Danish Hirschsprung Population

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2020年7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
173
试验地点
1
主要终点
Internal Consistency (IC) assessed by Cronbach's Alpha

研究概览

简要总结

The Hirschsprung and anorectal malformation quality of life (HAQL) questionnaire is a disease-specific quality of life questionnaire with 5 different elements (3 questionnaires for patients (categories: age 8-11, 12-16, and >17 years) and two questionnaires for parents of patients (categories: patients aged 8-11 and 12-16 years).

In the first part of this study, the questionnaires will be translated via forward-backward-translation, culturally adapted and evaluated for content validity.

In the second part of the study, the questionnaires will be validated in a cohort of all eligible Hirschsprung patients from Odense University Hospital from 1985-2014.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Diagnosed with Hirschsprung's Disease between the years 1985-2014
  • Age > 7 years
  • Good Danish comprehension
  • Signed informed consent

排除标准

  • Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.

结局指标

主要结局

Internal Consistency (IC) assessed by Cronbach's Alpha

时间窗: Day 1

次要结局

  • Test-retest reliability assessed by intraclass-correlations coefficient(4 weeks)

研究者

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

Kristina Gosvig

Principal Investigator

University of Southern Denmark

研究点 (1)

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