Patient and Family Member Reactions to Biomarker-Informed ADRD Diagnoses

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 患有认知障碍。然而，学习AD生物标记物的潜在改变生命的本质 状况表明，必须仔细平衡这类测试的负担和好处。几个 对这类测试的个人影响的研究发现，披露AD生物标记物 结果不会导致临床抑郁、焦虑或自杀。大部分证据都是 由受过高等教育、认知健康的非西班牙裔白人组成的样本 作为研究方案的一部分进行了扫描。迫切需要超越 高精选人员披露生物标志物结果的心理安全性调查 研究参与者，以发展对全面的负担和好处的理解 在真实人群中进行AD生物标记物测试。拟议的研究将利用相当大的 在基于实践的大型医疗保险研究中全面确定特征的机会 受益人、患者对包括AD生物标记物的认知障碍的诊断反应 测试。这项新想法研究将在全美350个地点招募7,000名医疗保险受益人 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，在AD及其相关研究中历史上代表性不足 精神障碍(ADRD)。这项拟议的研究已经得到了新想法组织的审查和批准 研究与出版委员会。我们将招募500名新想法参与者参加 为期6个月的观察性研究旨在解决以下具体目标。目标1.量化范围 以及对生物标记物信息认知诊断的情绪反应模式，并确定 哪些临床或人口统计因素与特定的反应有关。目标2. 在有症状的患者中表征一个人的AD生物标记物状态的“价值” 他们的直系亲属。目标3.确定少数民族的信息和支助需求 以及接受生物标志物信息认知诊断的不同文化背景的家庭。我们最重要的是 假说是对生物标记物通知的ADRD诊断的反应是不同的，并且 与不同的临床和社会人口学因素有关。这项研究将推动该领域的 了解真实世界的患者和家庭对生物标记物通知的ADRD诊断的反应， 提供关键信息，指导诊断后资源监测和支持 最需要帮助的人。研究结果将为快速发展的最先进诊断技术的最佳实践提供参考 对认知障碍的评估。

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.