1. 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.
- Author
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Park S, Forester BP, Lapid MI, Harper DG, Hermida AP, Inouye SK, McClintock SM, Nykamp L, Petrides G, Schmitt EM, Seiner SJ, Mueller M, and Patrick RE
- Subjects
- Humans, Aberrant Motor Behavior in Dementia, Cognition, Psychomotor Agitation etiology, Psychomotor Agitation therapy, Clinical Studies as Topic, Alzheimer Disease, Dementia complications, Dementia therapy, Dementia psychology, Electroconvulsive Therapy adverse effects, Electroconvulsive Therapy methods, Electroconvulsive Therapy psychology
- 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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
- Published
- 2024
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