The DECISION study: protocol for the development and internal validation of a multimodal decision-making capacity...

Area of Science:

• Neuroscience
• Clinical Psychology
• Medical Ethics

Background:

• Decision-making capacity (DMC) assessment for neurocognitive disorders lacks standardization and is often subjective.
• Current instruments are resource-intensive and not adapted for real-world or stage-specific applications.

Purpose of the Study:

• To develop and internally validate a structured, multimodal framework for assessing DMC across the Alzheimer's disease continuum.
• To operationalize core DMC domains: understanding, appreciation, reasoning, and expression of choice.

Main Methods:

• A modular framework integrating neuropsychological profiling, informant measures, and decision scenarios.
• Internal validation against MacCAT-T, with CDR for disease characterization.
• Co-design approach with patients, caregivers, clinicians, and experts.

Main Results:

• The framework provides standardized scoring and quantifiable outputs for DMC assessment.
• Evidence generated on feasibility, reliability, and criterion validity of the multimodal approach.
• Exploratory analyses examine associations between DMC and neurodegenerative disease markers.

Conclusions:

• The developed framework supports transparent and quantifiable capacity assessment within the German legal context.
• It integrates cognitive, functional, and contextual dimensions for cognitively impaired populations.
• Potential to inform future research and ethically robust consent procedures after external validation.