In dementia research, real-world data (RWD) is increasingly being used in accordance with data collected in intervention trials, to strengthen evidence of the effectiveness of new treatments.
In ROADMAP, Work Package 3 (WP3) has identified 300 European sources of RWD. WP2 have identified dementia-relevant, stakeholder priority outcomes for patients, caregivers, HTA and regulatory agencies and health professionals. Using a questionnaire, WP3 and WP4 have collated information from RWD custodians for 77 of these data sources, highlighting the outcomes that are or are not captured in their data source.
This report aims to highlight gaps in the available data for each outcome. It has three main objectives, to identify:
1. which outcomes can be obtained at scale from the RWD sources identified by WP3,
2. which outcomes are challenging to obtain from any of the data sources identified in WP3, and
3. which outcomes are not adequately captured in any data source, to the best of our knowledge?
Outcomes relating to cognitive abilities, functional abilities and independence, behavioural and neuropsychiatric symptoms, details of therapeutic treatment, and mortality & comorbidities are measured in many of the data sources. Fewer data sources measure significant disease related life events, medical investigations, use of health care and social services, and patient quality of life. A limited number of data sources capture information on caregiver-oriented outcomes, in particular outcomes related to the quality of the carer’s and family’s lives.
A number of limitations are outlined, such as the potential for overlap of outcomes across domains, and the variability of data included in each data source