Risk disclosure and preclinical Alzheimer's disease clinical trial enrollment.

Risk disclosure and preclinical Alzheimer's disease clinical trial enrollment.
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DOI:
10.1016/j.jalz.2012.03.001
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发表时间:
2013-05
期刊:
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子:
--
通讯作者:
Vickrey BG
Vickrey BG
中科院分区:
其他
文献类型:
--
作者:
Grill JD;Karlawish J;Elashoff D;Vickrey BG

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为了确定临床前阿尔茨海默病(AD)临床试验招募的促进因素和障碍,50名认知正常的参与者在随机分配到两种假设的AD风险情景之一中后接受了采访:1)AD的一般年龄相关风险,或2)AD风险增加50%。参与者提供了无线索的障碍和促进者的假设决定,他们是否会注册。确定了13个促进者主题和5个障碍主题。最常见的障碍是与服用研究药物相关的恐惧。那些被随机分配到AD风险增加的患者更频繁地引用降低个人风险作为促进因素(p=0.01),而较少引用时间作为入组障碍(p=0.02)。这些结果表明,招募临床前AD临床试验的潜在挑战,披露风险信息可能会提高招募。
To identify facilitators and barriers to recruitment to clinical trials in preclinical Alzheimer’s disease (AD), fifty cognitively normal participants were interviewed after being randomized to one of two hypothetical AD risk scenarios: 1) the general age-related risk for AD, or 2) being at 50% increased risk for AD. Participants provided uncued barriers and facilitators to the hypothetical decision of whether they would enroll. Thirteen themes of facilitators and five themes of barriers were identified. The most common barrier was fear related to taking study drug. Those randomized to being at increased risk for AD more frequently cited lowering personal risk as a facilitator (p=0.01) and less frequently cited time as a barrier to enrollment (p=0.02). These results suggest potential challenges to recruitment to preclinical AD clinical trials and that disclosing risk information may enhance enrollment.
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