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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02325661
Acronym
AKQOLVS
Enrollment
34
Registered
2014-12-25
Start date
2014-10-31
Completion date
2014-12-31
Last updated
2014-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

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.

Interventions

OTHERcognitive interviewing

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.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intersubject agreement on validation of the questions of the AKQoL30 minutes per patientConsistent answers by study participants on cognitive debriefing. This is a qualitative, not a quantitative measure.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026