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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive interviewing

Other

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.

Primary outcomes

Intersubject agreement on validation of the questions of the AKQoL

Time frame: 30 minutes per patient

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Acronym: AKQOLVS

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Dec 25, 2014
Registry last updated: Dec 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed