Speiser Dorothee, Heibges Maren, Besch Laura, Hilger Caren, Keinert Marie, Klein Katharina, Rauwolf Gudrun, Schmid Christine, Schulz-Niethammer Sven, Stegen Steffi, Westfal Viola, Witzel Isabell, Zang Benedikt, Kendel Friederike, Feufel Markus A
Department of Gynecology with Breast Center, Hereditary Breast and Ovarian Cancer Center, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Division of Ergonomics, Department of Psychology and Ergonomics, Technische Universität Berlin, Berlin, Germany.
JMIR Form Res. 2023 Apr 21;7:e41179. doi: 10.2196/41179.
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 (germline breast cancer gene) variants that increase the lifetime risk of breast and 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 paper, we elaborate on the clinical, regulatory, and practical premises of personalized counseling in Germany. By operationalizing these premises, we formulate 5 design principles that, we suggest, are specific enough to develop a digital tool (eg, iKNOW), yet wide-ranging enough to inform the development of counseling tools for personalized medicine more generally: (1) digital counseling tools should implement the current standard of care (eg, based on guidelines); (2) digital counseling tools should help to both standardize and personalize the counseling process (eg, 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 (eg, by using evidenced-based risk communication formats) and technically (eg, by means of responsive design for various devices); (4) digital counseling tools should respect the counselee's data privacy rights (eg, through strict pseudonymization and opt-in consent); and (5) digital counseling tools should be systematically and iteratively evaluated with the users in mind (eg, using formative prototype testing to ensure a user-centric design and a summative multicenter, randomized controlled trial). On the basis of these paradigmatic design principles, we hope that iKNOW can serve as a blueprint for the development of more digital innovations to support personalized counseling approaches in cancer medicine.
iKNOW是德国首个基于证据的数字工具，用于为有遗传性癌症风险的女性提供个性化咨询。该咨询工具专为携带致病性gBRCA（种系乳腺癌基因）变异的人群设计，这些变异会增加患乳腺癌和卵巢癌的终生风险。致病性变异携带者面临着复杂的个性化风险信息，医生必须能够以易于理解的方式传达这些信息，以便做出基于个人偏好的健康决策。在本文中，我们阐述了德国个性化咨询的临床、监管和实际前提。通过将这些前提付诸实践，我们制定了5条设计原则，我们认为这些原则足够具体，可用于开发数字工具（如iKNOW），同时范围足够广泛，可为更普遍的个性化医疗咨询工具的开发提供指导：（1）数字咨询工具应采用当前的护理标准（如基于指南）；（2）数字咨询工具应有助于使咨询过程标准化和个性化（如通过从通用信息库中进行基于个人偏好的咨询内容选择）；（3）数字咨询工具应使复杂信息在认知上易于获取（如通过使用基于证据的风险沟通形式），并在技术上易于获取（如通过针对各种设备的响应式设计）；（4）数字咨询工具应尊重咨询对象的数据隐私权（如通过严格的假名化和选择加入同意）；（5）数字咨询工具应以用户为中心进行系统的迭代评估（如使用形成性原型测试以确保以用户为中心的设计，并进行总结性多中心随机对照试验）。基于这些典型的设计原则，我们希望iKNOW能够成为开发更多数字创新工具的蓝图，以支持癌症医学中的个性化咨询方法。
