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.,Journal of Geriatric Psychiatry and Neurology

当前位置： X-MOL 学术 › J. Geriatr. Psychiatry Neurol. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

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.
Journal of Geriatric Psychiatry and Neurology ( IF 2.6 ) Pub Date : 2023-10-17 , DOI: 10.1177/08919887231207641
Soohyun Park _{1,

2} , Brent P Forester _{1,

2} , Maria I Lapid ₃ , David G Harper _{4,

5} , Adriana P Hermida ₆ , Sharon K Inouye _{7,

8} , Shawn M McClintock ₉ , Louis Nykamp ₁₀ , Georgios Petrides _{11,

12} , Eva M Schmitt ₇ , Stephen J Seiner ₁₃ , Martina Mueller ₁₄ , Regan E Patrick _{4,

5}

Affiliation

Department of Psychiatry, Tufts Medical Center, Boston, MA, USA.
Department of Psychiatry, Tufts University School of Medicine, Boston, MA, USA.
Department of Psychiatry & Psychology, Mayo Clinic, Rochester, MN, USA.
Geriatric Psychiatry Research Program, McLean Hospital, Belmont, MA, USA.
Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
Department of Psychiatry and Behavioral Science, Emory University School of Medicine, Atlanta, GA, USA.
Aging Brain Center, Hebrew Senior Life, Hinda and Arthur Marcus Institute for Aging Research, Boston, MA, USA.
Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Division of Psychology, Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA.
Pine Rest Christian Mental Health Services, Grand Rapids, MI, USA.
Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA.
Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
Psychiatric Neurotherapeutics Program, McLean Hospital, Belmont, MA, USA.
College of Nursing and Department of Public Health Sciences, Medical University of South Carolina (MUSC), Charleston, SC, USA.

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.

更新日期：2023-10-17

点击分享查看原文

点击收藏

阅读更多本刊最新论文本刊介绍/投稿指南

全部期刊列表>>