These authors shared the role of senior author.From the New York University Langone Medical Center (M.B.S.), Comprehensive Center on Brain Aging, Alzheimer's Disease Center, New York; University of Pennsylvania (K.H.), Department of Medicine, Alzheimer's Disease Center, Philadelphia; Brigham and Women's Hospital and Harvard Medical School (R.C.G.), Division of Genetics, Department of Medicine, Partners Center for Personalized Genetic Medicine, Boston, MA; and University of Pennsylvania (J.K.), Department of Medicine, Department of Medical Ethics and Health Policy, Alzheimer's Disease Center, Penn Neurodegenerative Disease Ethics and Policy Program, Philadelphia.
Neurology. 2013 Sep 24;81(13):1114-21. doi: 10.1212/WNL.0b013e3182a55f4a. Epub 2013 Aug 21.
To inform whether the Alzheimer's Disease Neuroimaging Initiative (ADNI) should change its policy of not returning research results to ADNI participants, we surveyed investigators and research staff about disclosing ADNI biomarker information to research participants, with particular emphasis on amyloid imaging results.
In April 2012, just before Food and Drug Administration approval of the amyloid-binding radiotracer, florbetapir, all ADNI investigators and personnel were recruited to complete an anonymous online survey that contained fixed choice and free-text questions.
Although ADNI participants often requested amyloid imaging results (the proportions of investigators who reported requests from more than half of their participants with normal cognition or mild cognitive impairment were 20% and 22%, respectively), across all diagnostic groups, the majority of ADNI investigators (approximately 90%) did not return amyloid imaging results to ADNI participants. However, the majority of investigators reported that, if the Food and Drug Administration approved florbetapir, they would support the return of amyloid imaging results to participants with mild cognitive impairment and normal cognition, but they emphasized the need for guidance on how to provide these results to participants and for research to assess the value of returning results as well as how returning results will affect study validity and participant well-being.
A majority of ADNI investigators support returning amyloid imaging results to ADNI participants. The findings that they want guidance on how to do this and research on the impact of disclosure suggest how to develop and monitor a disclosure process.
为了明确阿尔茨海默病神经影像学倡议（ADNI）是否应该改变其不向 ADNI 参与者返还研究结果的政策，我们调查了研究人员和研究人员关于向研究参与者披露 ADNI 生物标志物信息的情况，特别强调了淀粉样蛋白成像结果。
2012 年 4 月，在食品和药物管理局批准淀粉样蛋白结合放射性示踪剂 florbetapir 之前，所有 ADNI 研究人员和工作人员都被招募来完成一项匿名在线调查，其中包含固定选择和自由文本问题。
尽管 ADNI 参与者经常要求提供淀粉样蛋白成像结果（报告其正常认知或轻度认知障碍参与者中有一半以上要求的研究人员比例分别为 20%和 22%），但在所有诊断组中，大多数 ADNI 研究人员（约 90%）并未向 ADNI 参与者返还淀粉样蛋白成像结果。然而，大多数研究人员报告说，如果食品和药物管理局批准 florbetapir，他们将支持向轻度认知障碍和正常认知的参与者返还淀粉样蛋白成像结果，但他们强调需要指导如何向参与者提供这些结果，以及研究评估返回结果的价值以及返回结果将如何影响研究的有效性和参与者的幸福感。
大多数 ADNI 研究人员支持向 ADNI 参与者返还淀粉样蛋白成像结果。他们希望在如何做到这一点以及披露的影响方面得到指导的发现表明了如何制定和监测披露过程。
