Patient and Family Member Reactions to Biomarker-Informed ADRD Diagnoses

患者和家属对基于生物标志物的 ADRD 诊断的反应

• 批准号: 10589205
• 负责人: Joshua Grill
• 金额: $ 211.2万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10589205
• 关键词: Address; African American; Alzheimer' s disease pathology; Alzheimer' s disease related dementia; Alzheimer' s disease test; Alzheimer’s disease biomarker; Anxiety; Biological Markers; Black race; Clinical; Cognition Disorders; Cognitive; Demographic Factors; Diagnosis; Diagnostic; Emotional; Enrollment; Ethnic Origin; Evaluation; Family; Family member; Goals; Hispanic; Impaired cognition; Investigation; Latino; Learning; Life; Major Depressive Disorder; Medicare; Monitor; Nature; Not Hispanic or Latino; Observational Study; Participant; Patient Care; Patients; Pattern; Persons; Population; Population Heterogeneity; Protocols documentation; Publications; Reaction; Research; Resources; Risk; Safety; Sampling; Scanning; Site; Testing; amyloid imaging; beneficiary; clinical care; emotional distress; ethnic diversity; experience; patient response; psychologic; racial diversity; recruit; research clinical testing; response; sociodemographic factors; suicidal

Biomarkers of Alzheimer’s disease (AD) hold immense potential to impact clinical care of patients with cognitive disorders. Yet, the potentially life-altering nature of learning one’s AD biomarker status suggests that the burdens and benefits of such testing must be carefully balanced. Several studies of the personal implications of such testing have found that disclosing AD biomarker results does not cause clinical depression, anxiety, or suicidality. Most of this evidence has been derived from samples comprised of highly educated, cognitively healthy, non-Hispanic Whites who were scanned as part of a research protocol. There is pressing need to move beyond investigations of the psychological safety of disclosing biomarker results to highly selected research participants, to develop an understanding of the full range of burdens and benefits of AD biomarker testing in real-world populations. The proposed study will leverage a considerable opportunity to comprehensively characterize, within a large practice-based study of Medicare beneficiaries, patient responses to diagnoses of cognitive disorders that include AD biomarker testing. The New IDEAS study will enroll 7,000 Medicare beneficiaries at 350 sites throughout the US and provide amyloid imaging. At least 4,000 participants will be Black/African American or Hispanic/Latino, populations historically underrepresented in research on AD and related disorders (ADRD). The proposed study has been vetted and approved by the New IDEAS Research and Publications Committee. We will recruit 500 New IDEAS participants to enroll in a 6-month observational study to address the following Specific Aims. Aim 1. Quantify the range and patterns of emotional response to a biomarker-informed cognitive diagnosis, and determine which clinical or demographic factors are associated with specific responses. Aim 2. Characterize the “value of knowing” one’s AD biomarker status among symptomatic patients and their immediate family members. Aim 3. Identify the information and support needs of ethnically and culturally diverse families receiving biomarker-informed cognitive diagnoses. Our overarching hypothesis is that responses to biomarker-informed ADRD diagnoses are heterogeneous and associated with distinct clinical and sociodemographic factors. This study will advance the field’s understanding of real-world patient and family reactions to biomarker-informed ADRD diagnoses, providing critical information for directing post-diagnostic resources to monitor and support those most in need. Findings will inform best practices in the rapidly evolving state-of-the-art diagnostic evaluation of cognitive impairment.

阿尔茨海默氏病（AD）的生物标志物具有影响患者临床护理的巨大潜力 患有认知障碍。然而，学习广告生物标志物的潜在改变生活的本质 状态表明，必须仔细平衡伯恩伦斯和这种测试的好处。一些 对这种测试的个人影响的研究发现，披露广告生物标志物 结果不会导致临床抑郁，焦虑或自杀。大多数证据已经 源自包括受过高等教育的认知健康，非西班牙裔白人的样本 作为研究协议的一部分，被扫描。迫切需要超越 对披露生物标志物结果的心理安全性调查 研究参与者，以了解伯恩斯的全部范围和 现实世界中的AD生物标志物测试。拟议的研究将利用一个考虑 在Medicare的大型实践研究中，有机会全面地表征 贝尼奇，患者对包括AD生物标志物在内的认知障碍诊断的反应 测试。新的想法研究将在整个350个地点注册7,000名Medicare受益人 我们并提供淀粉样成像。至少有4,000名参与者将是黑人/非裔美国人或 西班牙裔/拉丁裔，历史上的人口在广告和相关研究中的代表性不足 疾病（ADRD）。拟议的研究已得到新想法的审查和批准 研究与出版物委员会。我们将招募500个新想法参与者参加 6个月的观察性研究以解决以下特定目的。目标1。量化范围 以及对生物标志物知识认知诊断的情感反应模式，并确定 哪些临床或人口统计学因素与特定反应有关。目标2。 表征有症状的患者中的“了解”一个人的AD生物标志物状态， 他们的直系亲属。目标3。确定种族的信息和支持需求 以及接受生物标志物知识认知诊断的文化多样化的家庭。我们的总体 假设是对生物标志物的ADRD诊断的反应是异质的，并且 与不同的临床和社会人口统计学因素相关。这项研究将推动该领域的 了解现实世界的患者和家庭对生物标志物信息的反应， 提供关键信息来指导后诊断后资源来监视和支持这些资源 最需要的。调查结果将为快速发展的最新诊断中的最佳实践提供信息 评估认知障碍。