{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T23:31:48Z","timestamp":1777851108028,"version":"3.51.4"},"reference-count":22,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2023,10,17]],"date-time":"2023-10-17T00:00:00Z","timestamp":1697500800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","award":["R01AG061100"],"award-info":[{"award-number":["R01AG061100"]}],"id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Hintz Family Foundation"},{"DOI":"10.13039\/100017934","name":"Rogers Family Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100017934","id-type":"DOI","asserted-by":"crossref"}]},{"name":"National Institute of Health"},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000133","name":"Agency for Healthcare Research and Quality","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000056","name":"NINR","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000056","id-type":"DOI","asserted-by":"crossref"}]},{"name":"NICHD"},{"DOI":"10.13039\/100000050","name":"NHLBI","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000050","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100006545","name":"NIMHD","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100006545","id-type":"DOI","asserted-by":"crossref"}]},{"name":"National Institute of Health\/National Institute on Aging","award":["R01AG061100"],"award-info":[{"award-number":["R01AG061100"]}]},{"name":"National Institute of Health\/National Institute on Aging","award":["NCT03926520"],"award-info":[{"award-number":["NCT03926520"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Geriatr Psychiatry Neurol"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Using the Severe Impairment Battery-8 (SIB-8), baseline floor effects are defined as a score of \u22645\/16. For patients without floor effects, a decline of \u22656 points is considered a CAE. For patients with floor effects, a decline of \u226530 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/08919887231207641","type":"journal-article","created":{"date-parts":[[2023,10,17]],"date-time":"2023-10-17T19:41:12Z","timestamp":1697571672000},"page":"234-241","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.1177","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2824-4264","authenticated-orcid":false,"given":"Soohyun","family":"Park","sequence":"first","affiliation":[{"name":"Department of 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