Findings
Digital measures must align with patient-defined meaningful aspects of health to ensure relevance and impact.
Continuous patient engagement is essential to identify meaningful concepts, validate measures, and refine endpoints.
The proposed framework—MAH, COI, Outcome, Endpoint—helps structure the development process, ensuring alignment with patient priorities.
Existing tools like the 6-minute walk test lack specificity and meaningfulness for many patients, highlighting the need for patient-centered digital alternatives.
Regulatory guidance emphasizes the importance of meaningful, patient-focused endpoints in clinical trials to support treatment evaluation and labeling claims.

Recommendations
Continuously involve patients in defining MAHs, COIs, outcomes, and endpoints to ensure relevance and usability.
Use the MAH-to-Endpoint framework to systematically develop measures that align with patient needs and clinical goals.
Select outcomes that demonstrate a clear relationship with MAHs and COIs, supported by patient and clinical validation.
Work collaboratively with patient advocacy groups, regulators, and researchers to harmonize development efforts and prioritize meaningful measures.
Ensure technology choices are driven by patient needs and clinical relevance, not the capabilities of available tools.

Regulatory Considerations
Ensure digital measures comply with regulatory expectations for meaningfulness, clinical relevance, and evidence generation.
Provide robust evidence linking MAHs, COIs, outcomes, and endpoints to support regulatory submissions.
Validate Endpoints Rigorously: Demonstrate that digital endpoints reliably reflect patient outcomes and provide value in clinical trial contexts.
Include Statistical Plans: Define how endpoints will be analyzed, ensuring alignment with trial protocols and regulatory frameworks.
Use patient-reported anchors to validate the clinical meaningfulness of changes in digital measures.