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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Other: cognitive interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cognitive interviewing<br>individual cognitive interviewing, 30 minutes per patient | Other: cognitive interviewing<br>* For the individual cognitive interviews we are using the two techniques to think aloud and the verbal probing. To think aloud means, that the patients are asked to express precisely what comes to their mind when reading the single questions. This means, the interviewer is interested in the line of thoughts, which arise when reading the question. Thereby, the problems which appear in the usually covert process of answering a question should be revealed. In a second step, we are using the verbal probing technique to identify possible misunderstandings of the questions or difficulties with single phrases. The interviewer asks further questions that target the patients' interpretation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intersubject agreement on validation of the questions of the AKQoL | Consistent answers by study participants on cognitive debriefing. This is a qualitative, not a quantitative measure. | 30 minutes per patient |