Using AD biomarker research results for clinical care A survey of ADNI investigators
Using AD biomarker research results for clinical care A survey of ADNI investigators
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DOI：
10.1212/wnl.0b013e3182a55f4a
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发表时间：
2013-09-24
期刊：
影响因子：
9.9
通讯作者：
Karlawish, Jason
中科院分区：
文献类型：
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作者：
Shulman, Melanie B.;Harkins, Kristin;Karlawish, Jason
目的：为了告知阿尔茨海默病神经影像学倡议（ADNI）是否应该改变其不向ADNI参与者返回研究结果的政策，我们对研究人员和研究人员进行了关于向研究参与者披露ADNI生物标志物信息的调查，特别强调淀粉样蛋白成像结果。2012年4月，就在美国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的调查人员和工作人员都被招募来完成一项匿名的在线调查，其中包含固定选择和自由文本问题。虽然ADNI参与者经常要求淀粉样蛋白成像结果（超过一半的参与者有正常认知或轻度认知障碍的比例分别为20%和22%），在所有诊断组中，大多数ADNI研究者（约90%）没有将淀粉样蛋白成像结果返回给ADNI参与者。然而，大多数研究人员报告说，如果美国食品和药物管理局批准florbetapir，他们将支持将淀粉样蛋白成像结果返回给轻度认知障碍和正常认知的参与者，但他们强调，需要指导如何向参与者提供这些结果，需要研究评估返回结果的价值，以及返回结果将如何影响研究有效性，结论：大多数ADNI研究人员支持将淀粉样蛋白成像结果返回给ADNI参与者。调查结果表明，他们希望得到如何做到这一点的指导，并对披露的影响进行研究，这就提出了如何制定和监测披露程序的建议。
Objective: 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.Methods: 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.Results: 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.Conclusions: 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.