Charlotte H Graafland, Laura Donker Kaat, Edo Richard, John C van Swieten, Harro Seelaar, Eline M Bunnik
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引用次数: 0
Abstract
Onset-predictive biomarker tests (OPBTs) for genetic frontotemporal dementia (FTD) may predict symptom onset in coming years. OPBT results could be used as inclusion criterion for clinical trials for FTD, but this requires disclosure of OPBT results to potential participants for informed consent. This creates a dilemma, as disclosure may be psychologically burdensome. Yet, individuals at risk of FTD may value OPBTs to relieve uncertainty and support planning for the future. This article provides an overview of considerations regarding disclosure using four themes (actionability, respect for autonomy and informed consent, psychological impact, social and societal impact), based on literature on return of individual research results and biomarker disclosure in Alzheimer's disease. Based on this, we argue that clinical validity and context of use are important considerations, and suggest that (1) counseling facilitates informed decision making, (2) clinical and psychological follow-up provides necessary support, and (3) impacts may be monitored in a pilot study.
Highlights: Ethical considerations regarding disclosure of onset-predictive biomarker test (OPBT) results include actionability, respect for autonomy and informed consent, psychological impact, and social and societal impact.The weight of each consideration depends heavily on the clinical validity of the OPBT results and the context of use.OPBT result disclosure to individuals at risk of genetic frontotemporal dementia (FTD) for clinical trial recruitment seems ethically acceptable.We suggest embedding OPBT results disclosure in counseling, follow-up, and a pilot study on impacts of OPBT results disclosure.
期刊介绍：
Alzheimer''s & Dementia: Diagnosis, Assessment & Disease Monitoring (DADM) is an open access, peer-reviewed, journal from the Alzheimer''s Association® that will publish new research that reports the discovery, development and validation of instruments, technologies, algorithms, and innovative processes. Papers will cover a range of topics interested in the early and accurate detection of individuals with memory complaints and/or among asymptomatic individuals at elevated risk for various forms of memory disorders. The expectation for published papers will be to translate fundamental knowledge about the neurobiology of the disease into practical reports that describe both the conceptual and methodological aspects of the submitted scientific inquiry. Published topics will explore the development of biomarkers, surrogate markers, and conceptual/methodological challenges. Publication priority will be given to papers that 1) describe putative surrogate markers that accurately track disease progression, 2) biomarkers that fulfill international regulatory requirements, 3) reports from large, well-characterized population-based cohorts that comprise the heterogeneity and diversity of asymptomatic individuals and 4) algorithmic development that considers multi-marker arrays (e.g., integrated-omics, genetics, biofluids, imaging, etc.) and advanced computational analytics and technologies.
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