The landscape of inequalities in dementia across Europe: First insights from the INTERDEM taskforce.

BACKGROUND: Getting a diagnosis of dementia does not equate to equitable access to care. People with dementia and unpaid carers face many barriers to care, which can vary within, and across, different countries and cultures. With little evidence across different countries, the aim of this scoping exercise was to identify the different and similar types of inequalities in dementia across Europe, and provide recommendations for addressing these. METHODS: We conducted a brief online survey with INTERDEM and INTERDEM Academy members across Europe, and with members of Alzheimer Europe's European Working Group of People with Dementia and Carers in February and March 2023. Members were asked about whether inequalities in dementia care existed within their country; if yes, to highlight three key inequalities. Responses on barriers were coded into groups, and frequencies of inequalities were calculated. Highlighted inequalities were discussed and prioritised at face-to-face and virtual consensus meetings in England, Ireland, Italy, and Poland, involving people with dementia, unpaid carers, health and social care providers, and non-profit organisations. RESULTS: Forty-nine academics, PhD students, people with dementia and unpaid carers from 10 countries (Belgium, Denmark, Germany, Greece, Ireland, Italy, Poland, Malta, Netherlands, UK) completed the survey. The most frequently identified inequalities focused on unawareness and lack of information, higher level system issues (i.e. lack of communication among care professionals), lack of service suitability, and stigma. Other barriers included workforce training and knowledge, financial costs, culture and language, lack of single-point-of-contact person, age, and living location/postcode lottery. There was general consensus among people living dementia and care providers of unawareness as a key barrier in different European countries, with varied priorities in Ireland depending on geographical location. CONCLUSIONS: These findings provide a first insight on dementia inequalities across Europe, generate cross-country learnings on how to address these inequalities in dementia, and can underpin further solution-focused research that informs policy and key decision makers to implement changes.

Digital endpoints in clinical trials of Alzheimer's disease and other neurodegenerative diseases: challenges and opportunities.

Alzheimer's disease (AD) and other neurodegenerative diseases such as Parkinson's disease (PD) and Huntington's disease (HD) are associated with progressive cognitive, motor, affective and consequently functional decline considerably affecting Activities of Daily Living (ADL) and quality of life. Standard assessments, such as questionnaires and interviews, cognitive testing, and mobility assessments, lack sensitivity, especially in early stages of neurodegenerative diseases and in the disease progression, and have therefore a limited utility as outcome measurements in clinical trials. Major advances in the last decade in digital technologies have opened a window of opportunity to introduce digital endpoints into clinical trials that can reform the assessment and tracking of neurodegenerative symptoms. The Innovative Health Initiative (IMI)-funded projects RADAR-AD (Remote assessment of disease and relapse-Alzheimer's disease), IDEA-FAST (Identifying digital endpoints to assess fatigue, sleep and ADL in neurodegenerative disorders and immune-mediated inflammatory diseases) and Mobilise-D (Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement) aim to identify digital endpoints relevant for neurodegenerative diseases that provide reliable, objective, and sensitive evaluation of disability and health-related quality of life. In this article, we will draw from the findings and experiences of the different IMI projects in discussing (1) the value of remote technologies to assess neurodegenerative diseases; (2) feasibility, acceptability and usability of digital assessments; (3) challenges related to the use of digital tools; (4) public involvement and the implementation of patient advisory boards; (5) regulatory learnings; and (6) the significance of inter-project exchange and data- and algorithm-sharing.

Intelligent digital tools for screening of brain connectivity and dementia risk estimation in people affected by mild cognitive impairment: the AI-Mind clinical study protocol.

More than 10 million Europeans show signs of mild cognitive impairment (MCI), a transitional stage between normal brain aging and dementia stage memory disorder. The path MCI takes can be divergent; while some maintain stability or even revert to cognitive norms, alarmingly, up to half of the cases progress to dementia within 5 years. Current diagnostic practice lacks the necessary screening tools to identify those at risk of progression. The European patient experience often involves a long journey from the initial signs of MCI to the eventual diagnosis of dementia. The trajectory is far from ideal. Here, we introduce the AI-Mind project, a pioneering initiative with an innovative approach to early risk assessment through the implementation of advanced artificial intelligence (AI) on multimodal data. The cutting-edge AI-based tools developed in the project aim not only to accelerate the diagnostic process but also to deliver highly accurate predictions regarding an individual's risk of developing dementia when prevention and intervention may still be possible. AI-Mind is a European Research and Innovation Action (RIA H2020-SC1-BHC-06-2020, No. 964220) financed between 2021 and 2026. First, the AI-Mind Connector identifies dysfunctional brain networks based on high-density magneto- and electroencephalography (M/EEG) recordings. Second, the AI-Mind Predictor predicts dementia risk using data from the Connector, enriched with computerized cognitive tests, genetic and protein biomarkers, as well as sociodemographic and clinical variables. AI-Mind is integrated within a network of major European initiatives, including The Virtual Brain, The Virtual Epileptic Patient, and EBRAINS AISBL service for sensitive data, HealthDataCloud, where big patient data are generated for advancing digital and virtual twin technology development. AI-Mind's innovation lies not only in its early prediction of dementia risk, but it also enables a virtual laboratory scenario for hypothesis-driven personalized intervention research. This article introduces the background of the AI-Mind project and its clinical study protocol, setting the stage for future scientific contributions.

Keeping track of and recognizing the value of Public Involvement work in dementia research.

The Public Involvement (PI) of people with dementia is slowly but progressively moving from a "nice to have" to a "must have" element of good-quality dementia research. Research funders and ethics committees increasingly ask for evidence of the planning of such involvement. The actual conduct and outcome of PI are, however, unfortunately typically under or inadequately reported. In this article, we provide an overview of what PI is and why it is important to dementia research and Alzheimer Europe's approach to PI. We draw on our recent experience of compiling a set of examples of PI in different European projects in publicly available sources. This highlighted the difficulty of finding information about PI activities and the almost total lack of details of such activities in formal reports, official records, and/or public project websites. In this article, we emphasize gaps and call for more stringent conditions for the inclusion and reporting of PI work in the context of the approval and funding of dementia research projects. We call for the establishment of obligatory reporting on the nature, specific challenges, and impact of PI in dementia research in formal reports (e.g., to funders), in public project websites, and in peer-reviewed articles. Such reporting should cover several key factors such as who was involved, how they were involved, and what impact PI had on the research process.

Empowering interventions for people living with dementia: A European survey.

AIMS: We aim to identify existing empowerment interventions for people living with dementia and to explore which used interventions and projects are considered empowering and why. DESIGN: This was an online survey. METHODS: We conducted an online survey between May 2018 and July 2018 amongst professionals interested in dementia care in Europe. Interventions were clustered within the ecological model for health promotion. Reasons from respondents as to why they considered interventions to be empowering were analysed and structured according to a recently developed conceptual framework of empowerment for people living with dementia. RESULTS: Seventy-three respondents from 23 countries together mentioned 98 interventions or projects, of which 90 were unique. Interventions focused on the (inter)personal (n = 54), organizational (n = 15), communal (n = 6) and societal (n = 15) levels. A broad range of interventions were considered empowering, but no interventions were specifically developed for, nor aimed at, empowerment. Reasons as to why respondents considered these interventions as empowering fitted the framework's domains. CONCLUSION: This European survey provides insights into interventions considered empowering for people living with dementia. An important step that needs to be taken is to develop and test interventions that specifically aim to promote empowerment for people living with dementia. IMPACT: Empowerment may encourage people with dementia to live the life they choose, and focus on what is possible, instead of what is no longer possible. Many interventions are considered as empowering for people living with dementia, however no interventions could be identified that were specifically developed for or aimed at empowerment. This study shows that for promoting empowerment, it is necessary to develop and test interventions that specifically aim for empowerment, do this in collaboration with relevant stakeholders, and in this way support people living with dementia to live according to their competencies, talents and wishes.

Evaluation of patient engagement in medicine development: A multi-stakeholder framework with metrics.

BACKGROUND: Patient engagement is becoming more customary in medicine development. However, embedding it in organizational decision-making remains challenging, partly due to lack of agreement on its value and the means to evaluate it. The objective of this project was to develop a monitoring and evaluation framework, with metrics, to demonstrate impact and enhance learning. METHODS: A consortium of five patient groups, 15 biopharmaceutical companies and two academic groups iteratively created a framework in a multi-phase participatory process, including analysis of its application in 24 cases. RESULTS: The framework includes six components, with 87 metrics and 15 context factors distributed among (sub)components: (a) Input: expectations, preparations, resources, representativeness of stakeholders; (b) Activities/process: structure, management, interactions, satisfaction; (c) Learnings and changes; (d) Impacts: research relevance, study ethics and inclusiveness, study quality and efficiency, quality of evidence and uptake of products, empowerment, reputation and trust, embedding of patient engagement; (e) Context: policy, institutional, community, decision-making contextual factors. Case study findings show a wide variation in use of metrics. There is no 'one size fits all' set of metrics appropriate for every initiative or organization. Presented sample sets of metrics can be tailored to individual situations. CONCLUSION: Introducing change into any process is best done when the value of that change is clear. This framework allows participants to select what metrics they value and assess to what extent patient engagement has contributed. PATIENT CONTRIBUTION: Five patient groups were involved in all phases of the study (design, conduct, interpretation of data) and in writing the manuscript.

Understanding multi-stakeholder needs, preferences and expectations to define effective practices and processes of patient engagement in medicine development: A mixed-methods study.

BACKGROUND: The holistic evolution of patient engagement in medicines development requires a more detailed understanding of the needs of all involved stakeholders, and one that better accounts for the specific needs of some potentially vulnerable patient populations and key stages in medicines development. OBJECTIVE: The purpose of this convergent mixed-methods study was to better understand the needs of different stakeholders concerning patient engagement at three key stages in medicines development: research priority setting, clinical trial design and early dialogues with Health Technology Assessment bodies and regulators. DESIGN: This study brought together findings from three sources: i) an online questionnaire, ii) face-to-face consultations with two potentially vulnerable patient populations, a workshop with Health Technology Assessment bodies, and iii) three-step modified Delphi methodology. RESULTS: Overall stakeholders still need additional varied support mechanisms to undertake, sustain or measure value of patient engagement. Health Technology Assessment bodies need better rationale for patient engagement in early dialogue and tools to support its implementation. Improved awareness and understanding of the need and value that involving patients, who are often considered as potentially vulnerable, can bring is needed, as is better accommodation of their specific needs. Similarly, weighted Delphi categories were as follows: aims and objectives, and sustainability. Several additional themes were common across the three key stages in medicines development. CONCLUSION: This broad-reaching study provides the blocks needed to build a framework for patient engagement in medicines development. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in review and interpretation of data.

The language of behaviour changes in dementia: A mixed methods survey exploring the perspectives of people with dementia.

AIMS: The aim of this study was to explore the opinions of people with dementia, about the language used to describe changes in behaviour associated with dementia. DESIGN: This study adopted a human rights approach in a mixed methods convergent parallel synthesis design. METHODS: Online and paper-based questionnaire data were collected between November 2019 and March 2020. A combination of convenience and purposive sampling was used to invite people with dementia to participate. RESULTS: In total, 54 people completed the survey. There was no clear consensus on a preferred term, but 28.3% preferred the term 'unmet needs' for describing changes in behaviour associated with dementia. Qualitative data revealed important nuances and challenges for researchers and practitioners in relation to terminology for this paradigm. Participants felt that the language we use to talk about changes in behaviour could influence how people with dementia are viewed and treated and how people feel about themselves. CONCLUSION: The majority of participants were familiar with a range of terminology. There was no universal agreement on terminology, but there was an overall preference for terms that reflect the unmet needs likely to underlie perceived changes in behaviour. IMPACT: People with dementia raised concerns about the language used to describe changes in behaviour that can occur in dementia. There is scope for improvements in the language used for this paradigm in both research and practice. Following a diagnosis of dementia, clinicians need to take the time to explore an individual's preferences and understandings. They can then share their own understanding about the potential for changed behaviour and if relevant, how any negative impact of this may be minimized.

Selecting Remote Measurement Technologies to Optimize Assessment of Function in Early Alzheimer's Disease: A Case Study.

Despite the importance of function in early Alzheimer's disease (AD), current measures are outdated and insensitive. Moreover, COVID-19 has heighted the need for remote assessment in older people, who are at higher risk of being infection and are particularly advised to use social distancing measures, yet the importance of diagnosis and treatment of dementia remains unchanged. The emergence of remote measurement technologies (RMTs) allows for more precise and objective measures of function. However, RMT selection is a critical challenge. Therefore, this case study outlines the processes through which we identified relevant functional domains, engaged with stakeholder groups to understand participants' perspectives and worked with technical experts to select relevant RMTs to examine function. After an extensive literature review to select functional domains relevant to AD biomarkers, quality of life, rate of disease progression and loss of independence, functional domains were ranked and grouped by the empirical evidence for each. For all functional domains, we amalgamated feedback from a patient advisory board. The results were prioritized into: highly relevant, relevant, neutral, and less relevant. This prioritized list of functional domains was then passed onto a group of experts in the use of RMTs in clinical and epidemiological studies to complete the selection process, which consisted of: (i) identifying relevant functional domains and RMTs; (ii) synthesizing proposals into final RMT selection, and (iii) verifying the quality of these decisions. Highly relevant functional domains were, "difficulties at work," "spatial navigation and memory," and "planning skills and memory required for task completion." All functional domains were successfully allocated commercially available RMTs that make remote measurement of function feasible. This case study provides a set of prioritized functional domains sensitive to the early stages of AD and a set of RMTs capable of targeting them. RMTs have huge potential to transform the way we assess function in AD-monitoring for change and stability continuously within the home environment, rather than during infrequent clinic visits. Our decomposition of RMT and functional domain selection into identify, synthesize, and verify activities, provides a pragmatic structure with potential to be adapted for use in future RMT selection processes.

Towards capturing meaningful outcomes for people with dementia in psychosocial intervention research: A pan-European consultation.

BACKGROUND: People with dementia are often marginalized and excluded from influence, also in relation to dementia research. There is, however, a growing requirement for inclusion through Patient and Public Involvement (PPI), but there is still limited knowledge on how researchers can fully benefit from the involvement of people with dementia in the development and testing of psychosocial interventions. This paper describes the results of a pan-European consultation with people with dementia, synthesizing their views on outcomes of psychosocial interventions. OBJECTIVE: To involve people with dementia in establishing what are meaningful outcomes when participating in psychosocial interventions. SETTING AND PARTICIPANTS: Consultations took place at four divergent sites across Europe, involving twenty-five people with dementia from nine European countries. METHODS: The methods used for the consultation were developed through an iterative process involving people with dementia. Data from the consultation were analysed from a thematic analysis approach. RESULTS: The results suggested that people with dementia wish to participate in interventions that enhance their well-being, confidence, health, social participation and human rights. This highlights a need for improvements in psychosocial research to capture these outcomes. DISCUSSION AND CONCLUSIONS: Involving people with dementia in discussions of psychosocial interventions has enhanced our understanding about meaningful outcome measures in research and methods of data collection. This study suggests that new outcome measures in psychosocial research are needed where concepts of positive psychology and social health can guide innovation and outcome measurement.

Alzheimer Europe's position on involving people with dementia in research through PPI (patient and public involvement).

This paper reflects Alzheimer Europe's position on PPI (patient and public involvement) in the context of dementia research and highlights some of the challenges and potential risks and benefits associated with such meaningful involvement. The paper was drafted by Alzheimer Europe in collaboration with members of INTERDEM and the European Working Group of People with Dementia. It has been formally adopted by the Board of Alzheimer Europe and endorsed by the Board of INTERDEM and by the JPND working group 'Dementia Outcome Measures - Charting New Territory'. Alzheimer Europe is keen to promote the involvement of people with dementia in research, not only as participants but also in the context of PPI, by generating ideas for research, advising researchers, being involved in consultations and being directly involved in research activities. This position paper is in keeping with this objective. Topics covered include, amongst others, planning involvement, establishing roles and responsibilities, training and support, managing information and input from PPI, recognising the contribution of people with dementia involved in research in this way, promoting and protecting the rights and well-being of people with dementia, training and support, and promoting an inclusive approach and the necessary infrastructure for PPI in dementia research.

A synthesis of the evidence on peer research with potentially vulnerable adults: how this relates to dementia.

BACKGROUND: There is limited literature around peer research in dementia. This study aims to identify the benefits, the risks and the practical challenges and to develop a model of good practice in peer research with people with dementia. METHODS: We searched on PsycInfo, PubMed and Google Scholar for empirical investigations or discussion papers on peer research. Given the limited literature in the field of dementia, we included studies with groups who share similar demographics (older people), experience of stigma (mental health service users) and exclusion from research (people with learning disabilities). We applied no restrictions on language and publication date. ANALYSIS: We identified three themes: the potential benefits, the potential risks and the practical challenges of peer research. We developed a model of good practice. The European Working Group of People with Dementia reviewed our paper and added to our findings. RESULTS: We included seven papers. Potential benefits of peer research included enriched data and empowering people with dementia. Potential risks included power differentials between researchers and issues of representativeness. The practical issues for good practice included the training of peer researchers, defining involvement and roles, working with cognitive impairment and considering resource implications. The European Working Group of People with Dementia emphasised the importance of equality issues. CONCLUSION: Involving people with dementia in peer research can generate several benefits, including empowerment and opportunities for inclusion for the peer researchers and the research participants living with dementia, challenging academics' traditional views on research processes and gathering enhanced research data. There remains a need for further research on the impact of peer research in dementia studies. Copyright © 2016 John Wiley & Sons, Ltd.

'I hate having nobody here. I'd like to know where they all are': Can qualitative research detect differences in quality of life among nursing home residents with different levels of cognitive impairment?

OBJECTIVE: To ascertain if similarities or differences exist in perceptions of quality of life (QoL) amongst nursing home (NH) residents with different levels of cognitive impairment (CI). METHOD: Face-to-face interviews using a simple 15-item semi-structured interview schedule with 61 older people with a CI (13 mild, 20 moderate and 28 severe) living in three Dublin area based NHs. RESULTS: Four key themes of QoL with accompanying sub-themes were identified: (1) social contact, (2) attachment, (3) pleasurable activities and (4) affect. Whilst some similarities existed between the three groups, results showed emerging differences, particularly between those with a mild and severe CI. In particular, the narratives of those with a severe CI reflected an absence of social contact, a quest for human contact and a lack of awareness of structured pleasurable activities. A large majority also reported feelings of loneliness, isolation and a search for home. CONCLUSIONS: Findings support the increasing evidence that people with a CI and even those with a probable advanced dementia can often still communicate their views and preferences about what is important to them. Whilst apathy, depression and anxiety are common features of advanced dementia, the social inclusion of these people in the day-to-day ethos of NH life needs a lot more careful consideration. More research is also needed to better understand the chronic and unique needs of this very vulnerable group of people.