An Information Tool Incorporating Real-World Outcome Data for Women With Metastatic Breast Cancer Eligible for Treatment With a CDK4/6 Inhibitor: Development and Evaluation

Abstract

Abstract Background Accelerating the transition to value-based health care (VBHC) is essential to ensure sustainable care delivery. VBHC maximizes patient value by optimizing outcomes, controlling costs, and leveraging data to improve quality and patient-doctor communication. Integrating real-world data in health care is important to achieve informed decisions, especially in palliative care, where choices are complex. Objective This study described the development and pilot-testing of an information tool that incorporates real-world outcome data for women with metastatic breast cancer who are initiating CDK4/6 inhibitor treatment. Real-world insights are needed to better inform these patients, in particular because real-world outcomes are known to differ from trial results because of larger heterogeneity in patient characteristics, and differences in frequency of check-ups and handling side effects. Methods We developed an information tool together with patient representatives and clinicians using a participatory development approach that consisted of five key steps: (1) establishment of a multidisciplinary steering group (n=10 steering group members), (2) mapping of the patient journey and patients’ needs through focus groups (n=9) and semistructured interviews (n=8), (3) extraction of real-world outcome data from electronic health records systems of 229 patients, (4) prototyping of the tool (n=10), and (5) pilot evaluation with the targeted patient population using semistructured interviews (n=38). We used qualitative analysis methods to analyze the focus group and interview data. Results We developed a tool consisting of (1) a communication aid for use during doctor-patient consultations (ie, KIJKgesprek [Stichting Kijksluiter]) and (2) a 2-component companion app with informational videos for use at home, both incorporating real-world outcome data (ie, KIJKbericht and KIJKsluiter [Stichting Kijksluiter]). Participants valued the tool for its clarity and structured design, reporting that the outcome data reinforced their experiences and facilitated the setting of realistic expectations. However, some participants described the outcome data as overwhelming, underscoring the importance of careful framing and delivery. Preferences regarding the type, level of detail, and timing of information presentation varied among participants, highlighting the necessity of individualizing information tools to meet diverse informational needs. Conclusions Most patients valued the inclusion of real-world outcome data in the information tool, although many found it challenging to process. Preferences for the type and presentation of information varied widely among individuals. Information tools incorporating outcome data have the potential to enhance patient understanding and support informed decision-making about care that they value most. However, these tools must be designed to allow for customization, ensuring they address individual informational needs and preferences effectively.