Background: Actinic keratoses (AK) are frequent skin lesions that can lead to invasive squamous cell carcinoma of the skin. A variety of lesion- or field-targeted treatment options exist and their efficacy has been demonstrated in numerous randomized controlled trials (RCTs). However, the reported endpoints are highly heterogeneous in terms of efficacy, tolerability and cosmetic outcome, making it difficult to assess and compare treatment options.
Methods: A systematic literature search will be conducted to analyze which endpoints are reported in RCTs. The focus will be on effectiveness, tolerability, and cosmesis. The reported endpoints of these studies, as well as their frequency and data collection times, will be documented in a standardized way to generate a comprehensive list of reported endpoints. In order to complete the identified outcomes in the literature search, focus groups with patients as well as structured interviews with established dermatologists will be conducted to identify patient-relevant and particularly practice-relevant endpoints. After identification, the evaluation of the endpoints begins. In a three-stage Delphi procedure, experts including patient representatives will evaluate the endpoints in a standardized and transparent manner. A final face-to-face consensus meeting will be the last Delphi round in which a final list of outcomes will be consented.
M.V. Heppt, T, Steeb, C. Berking (Department of Dermatology and Allergy, University Hospital, LMU Munich, Frauenlobstr. 9-11, 80337 Munich, Germany)
L. Schmitz (Department of Dermatology, Venereology and Allergology, Ruhr-University, Bochum, Germany)
U. Leiter, C. Garbe (Department of Dermatology, Center for Dermatooncology, University Hospital Tübingen, Liebermeisterstr. 25, 72076 Tübingen, Germany)
Disease Category: Cancer, Skin
Disease Name: Field-cancerization, Actinic keratosis, Skin cancer
Age Range: 18 - 99
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Policy makers
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Survey
- Systematic review
-A systematic literature search will be conducted to analyze which endpoints are reported in RCTs.
-Focus groups with patients as well as structured interviews with established dermatologists will be conducted to identify patient-relevant and particularly practice-relevant endpoints.
-In a three-stage Delphi procedure, experts including patient representatives will evaluate the endpoints in a standardized and transparent manner. A final face-to-face consensus meeting will be the last Delphi round in which a final list of outcomes will be consented.