JMIR Publications

ABSTRACT

iKNOW is the first evidence-based digital tool to support personalized counseling for women in Germany with a hereditary cancer risk. The counseling tool is designed for carriers of pathogenic gBRCA variants, which increase the lifetime risk of breast- and/or ovarian cancer. Carriers of pathogenic variants are confronted with complex, individualized risk information, and physicians must be able to convey this information in a comprehensible way to enable preference-sensitive health decisions. In this article, we elaborate on the clinical, regulatory and practical premises of personalized counseling in Germany. Operationalizing these premises, we formulate five design principles that, we suggest, are specific enough to develop a specific digital tool (e.g., iKNOW), yet wide-ranging enough to inform the development of counselling tools for personalized medicine more generally: (1) digital counseling tools should implement the current standard of care (e.g., based on guidelines); (2) digital counseling tools should help to both standardize and personalize the counseling process (e.g., by enabling the preference-sensitive selection of counseling contents from a common information base); (3) digital counseling tools should make complex information easy to access, both cognitively (e.g., by using evidenced-based risk communication formats) and technically (e.g., by means of responsive design for various devices); 4) digital counseling tools should respect counselee’s data privacy rights (e.g. through strict pseudonymization and opt-in consent); 5) digital counseling tools should be systematically and iteratively evaluated with the users in mind (e.g., using formative prototype testing to ensure a user-centric design and a summative multi-centre, randomized controlled trial). Based on these paradigmatic design principles, we hope that iKNOW can serve as a blueprint for the development of more digital innovations to support personalized counselling approaches in cancer medicine.