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.

阿尔茨海默病 (AD) 的生物标志物具有影响患者临床护理的巨大潜力 然而，了解 AD 生物标志物可能会改变人们的生活。 现状表明，必须仔细平衡此类测试的负担和好处。 对此类测试对个人影响的研究发现，披露 AD 生物标志物 结果不会导致临床抑郁、焦虑或自杀倾向。 源自受过高等教育、认知健康的非西班牙裔白人样本 作为研究方案的一部分进行扫描的人迫切需要超越。 向精心挑选的人披露生物标志物结果的心理安全性调查 研究参与者，以了解各种负担和好处 拟议的研究将利用大量的数据在现实世界人群中进行 AD 生物标志物测试。 在基于实践的大型医疗保险研究中全面表征的机会 受益者、患者对包括 AD 生物标志物在内的认知障碍诊断的反应 New IDEAS 研究将在全国 350 个地点招募 7,000 名医疗保险受益人。 美国并提供淀粉样蛋白成像 至少 4,000 名参与者将是黑人/非裔美国人或 西班牙裔/拉丁裔人口在 AD 及相关研究中历来代表性不足 拟议的研究已得到 New IDEAS 的审查和批准。 研究和出版委员会将招募 500 名 New IDEAS 参与者参加 为期 6 个月的观察性研究，旨在实现以下具体目标 1. 量化范围。 以及对基于生物标记的认知诊断的情绪反应模式，并确定 哪些临床或人口因素与特定反应相关。 描述有症状的患者中 AD 生物标志物状态的“了解价值” 目标 3. 确定少数民族的信息和支持需求。 以及接受基于生物标志物的认知诊断的多元文化家庭。 假设是，对基于生物标志物的 ADRD 诊断的反应是异质的，并且 与不同的临床和社会人口因素相关。这项研究将推动该领域的发展。 了解现实世界的患者和家属对基于生物标志物的 ADRD 诊断的反应， 提供关键信息，指导诊断后资源监测和支持这些人员 研究结果将为快速发展的最先进诊断提供最佳实践。 减值评估。