A Novel Approach to Monitoring Cognitive Adverse Events for Interventional Studies Involving Advanced Dementia Patients: Insights From the Electroconvulsive Therapy for Agitation in Dementia Study.

IF 2.9 4区 医学 Q2 CLINICAL NEUROLOGY Journal of Geriatric Psychiatry and Neurology Pub Date : 2024-05-01 Epub Date: 2023-10-17 DOI:10.1177/08919887231207641
Soohyun Park, Brent P Forester, Maria I Lapid, David G Harper, Adriana P Hermida, Sharon K Inouye, Shawn M McClintock, Louis Nykamp, Georgios Petrides, Eva M Schmitt, Stephen J Seiner, Martina Mueller, Regan E Patrick
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Abstract

Objective: To develop an individualized method for detecting cognitive adverse events (CAEs) in the context of an ongoing trial of electroconvulsive therapy for refractory agitation and aggression for advanced dementia (ECT-AD study).

Methods: Literature search aimed at identifying (a) cognitive measures appropriate for patients with advanced dementia, (b) functional scales to use as a proxy for cognitive status in patients with floor effects on baseline cognitive testing, and (c) statistical approaches for defining a CAE, to develop CAEs monitoring plan specifically for the ECT-AD study.

Results: Using the Severe Impairment Battery-8 (SIB-8), baseline floor effects are defined as a score of ≤5/16. For patients without floor effects, a decline of ≥6 points is considered a CAE. For patients with floor effects, a decline of ≥30 points from baseline on the Barthel Index is considered a CAE. These values were derived using the standard deviation index (SDI) approach to measuring reliable change.

Conclusions: The proposed plan accounts for practical and statistical challenges in detecting CAEs in patients with advanced dementia. While this protocol was developed in the context of the ECT-AD study, the general approach can potentially be applied to other interventional neuropsychiatric studies that carry the risk of CAEs in patients with advanced dementia.

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一种监测晚期痴呆患者干预研究中认知不良事件的新方法:从痴呆症患者激动的电休克治疗研究中获得的见解。
目的:在一项正在进行的晚期痴呆难治性躁动和攻击性电休克治疗试验(ECT-AD研究)中,开发一种检测认知不良事件(CAE)的个性化方法,(b)功能量表,用作基线认知测试中地板效应患者认知状态的指标,以及(c)定义CAE的统计方法,以制定专门用于ECT-AD研究的CAE监测计划。结果:使用严重损伤电池-8(SIB-8),基线地板效应定义为≤5/16分。对于没有地板效应的患者,下降≥6分被视为CAE。对于有地板效应的患者,Barthel指数从基线下降≥30分被视为CAE。这些值是使用标准偏差指数(SDI)方法得出的,用于测量可靠的变化。结论:提出的计划解决了检测晚期痴呆患者CAE的实际和统计挑战。虽然该方案是在ECT-AD研究的背景下制定的,但该通用方法可能适用于其他具有晚期痴呆患者CAE风险的介入性神经精神研究。
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来源期刊
CiteScore
6.20
自引率
0.00%
发文量
40
审稿时长
>12 weeks
期刊介绍: Journal of Geriatric Psychiatry and Neurology (JGP) brings together original research, clinical reviews, and timely case reports on neuropsychiatric care of aging patients, including age-related biologic, neurologic, and psychiatric illnesses; psychosocial problems; forensic issues; and family care. The journal offers the latest peer-reviewed information on cognitive, mood, anxiety, addictive, and sleep disorders in older patients, as well as tested diagnostic tools and therapies.
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