Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge School of Clinical Medicine, Cambridge, UK.
Department of Medical Ethics and Philosophy of Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
J Alzheimers Dis. 2018;62(2):487-498. doi: 10.3233/JAD-170813.
In clinical trials which target pathophysiological mechanisms associated with Alzheimer's disease, research participants who are recruited based on biomarker test results should be informed about their increased risk of developing Alzheimer's dementia. This paper presents the results of a qualitative focus group study of attitudes and concerns toward learning information about biomarker-based risk status among healthy research participants in the United Kingdom and Spain and people with dementia and their supporters/caregivers from countries represented in the European Working Group of People with Dementia of Alzheimer Europe. The study identified expectations related to learning risk status and preferences related to the content, quality, and follow-up of the disclosure process. The latter emphasize distinctions between risk and diagnoses, the importance of clear information about risk, and suggestions for risk reduction, as well as expectations for follow up and support. The implications of these preferences for practice are discussed. Providing details of research participants' experience and views may serve as a guide for the development of processes for the responsible disclosure of Alzheimer's disease biomarkers.
在针对与阿尔茨海默病相关的病理生理机制的临床试验中，应告知根据生物标志物测试结果招募的研究参与者他们患阿尔茨海默病痴呆症的风险增加。本文介绍了一项定性焦点小组研究的结果，该研究针对的是英国和西班牙的健康研究参与者以及来自阿尔茨海默欧洲组织的欧洲痴呆症患者及其支持者/照顾者对了解基于生物标志物的风险状况的态度和关注。该研究确定了与学习风险状况相关的预期以及与披露过程的内容、质量和后续相关的偏好。后者强调了风险和诊断之间的区别、关于风险的清晰信息的重要性以及降低风险的建议，以及对随访和支持的期望。讨论了这些偏好对实践的影响。提供研究参与者的经验和观点的详细信息可能有助于制定负责任地披露阿尔茨海默病生物标志物的过程。
