Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants
Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants
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DOI：
10.1186/s13195-015-0112-7
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发表时间：
2015-05-12
影响因子：
9
通讯作者：
Karlawish, Jason
中科院分区：
文献类型：
--
作者：
Harkins, Kristin;Sankar, Pamela;Karlawish, Jason
简介：本研究的目的是开发一种过程，以最大限度地提高向参与阿尔茨海默病二级预防研究（如无症状阿尔茨海默病抗淀粉样蛋白治疗（A4）研究）的认知正常老年人披露正电子发射断层扫描（PET）淀粉样蛋白成像结果的安全性和有效性。方法：我们使用改良的德尔菲法来就最佳实践达成共识，从两个相关领域的专家那里收集并分析了三轮数据：基因检测的知情同意或人类淀粉样蛋白成像。专家们就（1）向正在考虑是否在临床试验背景下接受此类成像的人描述淀粉样蛋白成像的手册文本，以及（2）在此类试验中淀粉样蛋白PET结果披露的过程达成了共识。建议包括：在知情同意期间，潜在参与者应完成一次教育课程，在那里他们将获得口头和书面信息，涵盖有关淀粉样蛋白成像的已知和未知信息，包括可能的结果及其意义，结果对未来认知能力下降风险的影响，以及有关阿尔茨海默氏症和风险因素的信息。参与者应进行焦虑和抑郁筛查，以确定是否适合接受淀粉样蛋白成像信息。主持会议的人应检查理解能力，并善于沟通和识别痛苦。成像应在知情同意的另一天进行，并在成像的另一天进行披露。披露应亲自进行，有时间提问。在披露时，调查人员应评估情绪和接受结果的意愿，并提供书面结果报告。电话随访在几天内应评估披露的影响，并定期评估抑郁和焦虑，与额外的监测和后续的参与者显示困扰，should be performed.Conclusions：我们开发了一个文件，用于与潜在的研究参与者描述的过程中淀粉样蛋白成像和淀粉样蛋白成像结果的影响;以及注意持续监测情绪和安全以接收该信息的披露过程。本文件和流程将用于A4研究，并可适用于其他研究环境。
Introduction: The objective of this study was to develop a process to maximize the safety and effectiveness of disclosing Positron Emission Tomography (PET) amyloid imaging results to cognitively normal older adults participating in Alzheimer's disease secondary prevention studies such as the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Study.Methods: Using a modified Delphi Method to develop consensus on best practices, we gathered and analyzed data over three rounds from experts in two relevant fields: informed consent for genetic testing or human amyloid imaging.Results: Experts reached consensus on (1) text for a brochure that describes amyloid imaging to a person who is considering whether to undergo such imaging in the context of a clinical trial, and (2) a process for amyloid PET result disclosure within such trials. Recommendations included: During consent, potential participants should complete an educational session, where they receive verbal and written information covering what is known and unknown about amyloid imaging, including possible results and their meaning, implications of results for risk of future cognitive decline, and information about Alzheimer's and risk factors. Participants should be screened for anxiety and depression to determine suitability to receive amyloid imaging information. The person conducting the sessions should check comprehension and be skilled in communication and recognizing distress. Imaging should occur on a separate day from consent, and disclosure on a separate day from imaging. Disclosure should occur in person, with time for questions. At disclosure, investigators should assess mood and willingness to receive results, and provide a written results report. Telephone follow-up within a few days should assess the impact of disclosure, and periodic scheduled assessments of depression and anxiety, with additional monitoring and follow-up for participants showing distress, should be performed.Conclusions: We developed a document for use with potential study participants to describe the process of amyloid imaging and the implications of amyloid imaging results; and a disclosure process with attention to ongoing monitoring of both mood and safety to receive this information. This document and process will be used in the A4 Study and can be adapted for other research settings.