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

Decision-making capacity (DMC) is a prerequisite for valid informed consent, as well as being a key methodological requirement in clinical and epidemiological research. For individuals with neurocognitive disorders, DMC assessment is frequently based on subjective clinical judgment, with limited standardization and significant variability across settings. Current instruments are resource-intensive and not sufficiently adapted for stage-specific or real-world applications. To develop and internally validate a structured multimodal framework for assessing DMC in individuals across the Alzheimer's disease continuum.

We propose a modular assessment framework that operationalizes the core domains of DMC: understanding, appreciation, reasoning, and expression of choice. This is complemented by neuropsychological profiling, informant-based measures and structured decision scenarios. Internal validation will be performed against established functional reference standards, including the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), while the Clinical Dementia Rating (CDR) will be used for disease characterization only. Primary analyses focus on feasibility, reliability, and criterion validity. Biomarkers and neuroimaging measures are examined as exploratory contextual correlates of decisional vulnerability and are not used to define DMC. The codesign approach thus integrates both patient and caregiver perspectives as well as clinician and expert input, with focus group interviews providing a complementary, structured format to capture interdisciplinary professional perspectives.

The protocol is designed to generate evidence regarding feasibility, reliability, and criterion validity of a multimodal DMC assessment framework. It provides standardized scoring and quantifiable outputs, as well as a basis for stage-sensitive interpretation. Exploratory analyses will further evaluate associations between functional DMC and markers of neurodegenerative disease burden. This methodological framework provides a standardized, reproducible approach to assessing decision-making capacity in cognitively vulnerable populations.

Developed within the German legal framework, it integrates cognitive, functional, and contextual dimensions to support more transparent and quantifiable capacity assessment. Following external validation, the framework may inform future clinical studies, observational research, and ethically robust consent procedures in cognitively impaired populations.