Communicating and Using Dementia Risk Evidence

Abstract

Advances in biomarkers, genetics, and other data used as dementia risk evidence (DRE) are increasingly informing clinical diagnosis and management. The purpose of this Mini-Forum is to provide a solutions-based discussion of the ethical and legal gaps and practical questions about how to use and communicate these data. Investigators often use DRE in research. When participants ask for their personal results, investigators have concerns. Will data that was intended to study groups be valid for individuals? Will sharing data cause distress? Debates around sharing DRE became heated when blood-based amyloid tests and amyloid reducing drugs appeared poised to enable clinicians easily to identify people with elevated brain amyloid and reduce it with a drug. Such an approach would transform the traditional role of DRE from investigational to foundational; however, then the high costs, uncertain clinical benefits and risks of the therapy led to an urgent need for education to support clinical decision making. Further complicating DRE use are direct to consumer genetic testing and increasingly available biomarker testing. Withholding DRE becomes less feasible and public education around responsible use and understanding become vital. A critical answer to these legal and ethical issues is supporting education that clearly delineates known risks, benefits, and gaps in knowledge, and communication to promote understanding among researchers, clinicians, patients, and all stakeholders. This paper provides an overview and identifies general concepts and resource documents that support more informed discussions for individuals and interdisciplinary groups.

The importance of the dyad: Participant perspectives on sharing biomarker results in Alzheimer's disease research

“…Given the high willingness among participants to share results, research could at a minimum incorporate support persons in the disclosure components of preclinical AD research, or even encourage their participation. If conducted in diverse patient populations, such data could expand the evidence base for disclosure best‐practices by providing opportunities to evaluate various communication strategies; and by assessing participant and support person perspectives on key elements of disclosure such as comprehension, planning, and discussions about lifestyle changes in different groups 23,31 …”

“…21 person perspectives on key elements of disclosure such as comprehension, planning, and discussions about lifestyle changes in different groups. 23,31 Incorporating dyads may also allow a more robust determination of what influences psychosocial outcomes after disclosure. While outcomes in clinical trial populations are safe, surveys in registry and general public populations suggest that around 10% of individuals would consider suicide if they learned they were at increased risk for AD.…”

“…If conducted in diverse patient populations, such data could expand the evidence base for disclosure best‐practices by providing opportunities to evaluate various communication strategies; and by assessing participant and support person perspectives on key elements of disclosure such as comprehension, planning, and discussions about lifestyle changes in different groups. 23 , 31 …”

Ethical Issues of Primary and Secondary Dementia Prevention

“…In our understanding, the primary consideration lies in communicating probabilities and uncertainties in a systematic, transparent, and understandable manner (Rosen, 2022). Recommendations on dementia risk communication were recently published (Visser et al, 2021); more work needs to be done to integrate these recommendations into a shared decision-making framework for dementia prediction.…”

The Return of Biomarker Results in Research: Balancing Complexity, Precision, and Ethical Responsibility

“…Important progress has been made to further understand the practical and ethical issues involved in communicating dementia biomarker results in research studies [2][3][4][5][6][7][8]. From an ethical standpoint that is anchored in the Declaration of Helsinki principles to promote and safeguard the health, well-being, and rights of human research subjects [9], recommendations for biomarker disclosure are evolving.…”