BACKGROUND: The Alzheimer’s Disease Patient and Caregiver Engagement™ Initiative‘s What Matters Most™ (WMM) Research Program includes seminal studies to identify and measure treatment-related needs, preferences, and priorities of people living with Alzheimer’s disease (PLWAD) and their informal care partners (CPs). WMM research identified 42 concepts deemed to be of highest relevance and importance in treatment related needs across the AD spectrum (preclinical – severe AD). Now, the WMM Next Generation Studies (WMM NG) are generating data to contextualize findings through a conceptual model of disease, verify previously identified concepts, and learn of new emerging concepts from a more diverse and inclusive study sample. Results will be used to broaden the context of an online survey to inform additional studies, including health economic evaluations, across the Alzheimer’s research field.
METHODS: A draft conceptual model of disease was developed building on an existing model (Hartry, 2018) after careful examination of previously collected WMM data (DiBenedetti, 2020; Hauber, 2023). A cross-sectional, observational qualitative research study was conducted, comprised of a series of individual, in-depth interviews of those with clinically confirmed PLWAD and their CPs. Analyses of these data include qualitative content analysis and thematic analysis methods (Hsiu-Fang, 2005).
RESULTS: The 42 WMM concepts were categorized across thought processing (14), communication (3), mood/emotions (6), daily activities (12), social life/activities, (3) and independence (4) domains to form a draft conceptual model of disease. A total of 64 PLWAD and CPs of diverse ethnic and cultural backgrounds participated in in-depth, web-based interviews. Results reaffirmed the 42 WMM concepts, informed the model structure, and added missing concepts. Further, cognitive debriefing approaches elucidated participant perception of the terms “bother” and “interference” describing emotional connotation of these words, compared to the assessment of “impact”, to inform development of AD burden survey items.
CONCLUSIONS: WMM concepts contextualized by domains offer a roadmap to support future clinical trials seeking to measure clinically meaningful outcomes and patient-centric endpoints. WMM NG data collection will enhance robustness of the findings to evaluate the impact of disease symptoms and inform health economic evaluation. The conceptual model will be refined continuously over the WMM research.
