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临床试验/NCT02325661
NCT02325661已完成不适用

Open Uncontrolled Validation Study for the German Version of the Actinic Keratosis Quality of Life Questionnaire (AKQoL)

University of Zurich2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014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
34
试验地点
2
主要终点
Intersubject agreement on validation of the questions of the AKQoL

研究概览

简要总结

The objective of this study is to translate the "AKQoL"-questionnaire which measures the quality of life of patients with actinic keratosis into German and to validate it for the Swiss population.

By using the technique of cognitive interviewing the investigators are focussing on the patients' understanding of the questions. The first session of cognitive interviews will show, where there is need for improvement in terms of misinterpreted phrases or vaguely worded questions. The goal is to rephrase the questions according to the feedback of the patients. The revised version will then be presented to a new population.

详细描述

Actinic keratosis is a UV-induced skin disease, which presents as a reddish, squamous and sometimes itchy lesion. Actinic keratosis seems to have a negative impact on patients' quality of life. Esmann et al. elaborated on patients with actinic keratosis from Zealand, Denmark a questionnaire which measures the quality of life.

The objective of this study is to translate this questionnaire into German and to validate it for the Swiss population. This questionnaire might become part of a planned national register for data collection of patients with AK.

The investigators will assess the content validity of the questionnaire by using the technique of cognitive interviewing. The investigators are going to talk 34 patients with AK from the department of Dermatology, University Hospital Zurich through the translated version. Thereby, the investigators are focusing on the patients' understanding of the questions.

The first session of cognitive interviews will show, where there is need for improvement in terms of misinterpreted phrases or vaguely worded questions. The goal is to rephrase the questions in the sense that they become more clear and are understood by different interviewee in the same way. The revised version will then be presented to a new population. The performance of cognitive interview sessions and revisions will continue until the survey will be approved by at least 80% of the respondents.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

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

  • Patients with actinic keratosis of the department of Dermatology, University Hospital Zurich
  • Male and Female subjects > 18 years of age
  • Good understanding of written and spoken German
  • Sufficient physical and mental capacity to comprehend the questions
  • Written informed consent by the participant

排除标准

  • Lack of informed consent

结局指标

主要结局

Intersubject agreement on validation of the questions of the AKQoL

时间窗: 30 minutes per patient

Consistent answers by study participants on cognitive debriefing. This is a qualitative, not a quantitative measure.

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 (2)

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