在阿尔茨海默氏病临床试验中信息人替代的影响
Mikaela K Nishida1, Michelle M Nuño2, Joshua D Grill3,4,5,6
1Department of Statistics Donald Bren School of Information and Computer Sciences University of California, Irvine Irvine California USA.
Alzheimer's & dementia (New York, N. Y.)
|December 14, 2023
概括
在阿尔茨海默病 (AD) 试验中,信息人替代引入了日常生活得分的偏差和变化. 这影响了AD临床试验数据的可靠性,当护理人员在参与研究期间改变时.
科学领域:
- 临床神经学 临床神经学
- 神经科学是一个神经科学.
- 老年学是一门学科.
背景情况:
- 阿尔茨海默病 (AD) 临床试验需要参与者注册一个可靠的告密者.
- 在阿尔茨海默氏症研究中,信息员数据对于评估疾病进展和治疗疗效至关重要.
研究的目的:
- 调查信息人替代对阿尔茨海默病合作研究日常生活活动 (ADCS-ADL) 在阿尔茨海默病试验中的得分的影响.
- 在纵向AD研究中,通过改变信息人来量化引入的偏差和可变性.
主要方法:
- 来自四项AD临床试验的数据分析,涉及1336名参与者.
- 利用通用估计方程来评估信息人更换与访问之间ADCS-ADL分数变化之间的关联.
- 采用协差分析和F测试来评估替换对18个月变化和得分差异的影响.
主要成果:
- 大约5%的参与者经历了信息人更换.
- 信息人更换与ADCS-ADL得分的访问间平均变化显著下降 (-2.44分).
- 随着信息人更换,ADCS-ADL得分的差异显著增加 (差异比为1.80).
结论:
- 信息人更换引入了显著的偏差,并增加了研究访问之间的ADCS-ADL得分的变化.
- 这些发现凸显了需要考虑信息提供者的变化,以确保阿尔茨海默病试验数据的准确性和可靠性.
- 减轻信息人替代影响的策略对于在AD研究中获得可靠的临床试验结果至关重要.
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