PiKoM: Pilot phase of a case-control study on the impact of the German national skin cancer screening on the incidence of advanced melanomas and mortality from malignant melanoma

The evidence for the benefit of skin cancer screening (SCS) in terms of mortality reduction is severely limited for methodological reasons. To investigate this benefit, a randomized controlled trial (RCT) or at least a cohort study would be desirable. However, such studies are not feasible in Germany, particularly due to the established skin cancer screening program and the required sample size. However, a case-control study on the influence of skin cancer screening on the risk of developing late-stage melanoma or dying from melanoma appears feasible and affordable.

A case-control study can be used to investigate whether patients with advanced melanoma or those who have died from melanoma participated in skin cancer screening less frequently than matched controls from the general population.

This pilot project investigates the feasibility and practicality of such a case-control study. The survey instruments to be used will be developed and comprehensively tested for validity and applicability. To ensure a detailed and valid survey of screening participation and other activities for the early detection of melanoma, qualitative interviews will be conducted as part of the questionnaire development. Cognitive interviews will provide information about whether the questions are actually understood as intended and whether the intended information is being collected. Recruitment methods and the willingness of late-stage melanoma patients to participate will also be tested. Information on the screening history of cases and controls could be validated by dermatologists or by billing data from the Association of Statutory Health Insurance Physicians (Kassenärztliche Vereinigung) or health insurance companies. Whether this validation is possible and how it can be implemented in practice will also be examined in this pilot project.