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Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial
Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine...
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Published in: | Schizophrenia bulletin 2009-07, Vol.35 (4), p.719-729 |
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creator | Jeste, Dilip V. Palmer, Barton W. Golshan, Shahrokh Eyler, Lisa T. Dunn, Laura B. Meeks, Thomas Glorioso, Danielle Fellows, Ian Kraemer, Helena Appelbaum, Paul S. |
description | Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols. |
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We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols.</description><identifier>ISSN: 0586-7614</identifier><identifier>EISSN: 1745-1701</identifier><identifier>DOI: 10.1093/schbul/sbm148</identifier><identifier>PMID: 18245061</identifier><identifier>CODEN: SCZBB3</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Adult and adolescent clinical studies ; Biological and medical sciences ; Clinical Trials as Topic - standards ; Cognition Disorders - diagnosis ; Cognition Disorders - psychology ; Comprehension ; Decision Making ; Female ; Humans ; Informed Consent - psychology ; Informed Consent - standards ; Male ; Medical sciences ; Mental Competency ; Middle Aged ; Multimedia ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology. Psychiatry ; Psychoses ; Regular ; Research Subjects - psychology ; Schizophrenia ; Schizophrenia - diagnosis ; Schizophrenia - therapy ; Schizophrenic Psychology ; Severity of Illness Index</subject><ispartof>Schizophrenia bulletin, 2009-07, Vol.35 (4), p.719-729</ispartof><rights>Published by Oxford University Press 2008. 2009</rights><rights>2009 INIST-CNRS</rights><rights>Published by Oxford University Press 2008.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-c9e8e8db3e06a4faed522a82b5ad71d9a2b3112a5b8abbbfb40258f52f4be0e03</citedby><cites>FETCH-LOGICAL-c475t-c9e8e8db3e06a4faed522a82b5ad71d9a2b3112a5b8abbbfb40258f52f4be0e03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2696362/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2696362/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21640382$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18245061$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jeste, Dilip V.</creatorcontrib><creatorcontrib>Palmer, Barton W.</creatorcontrib><creatorcontrib>Golshan, Shahrokh</creatorcontrib><creatorcontrib>Eyler, Lisa T.</creatorcontrib><creatorcontrib>Dunn, Laura B.</creatorcontrib><creatorcontrib>Meeks, Thomas</creatorcontrib><creatorcontrib>Glorioso, Danielle</creatorcontrib><creatorcontrib>Fellows, Ian</creatorcontrib><creatorcontrib>Kraemer, Helena</creatorcontrib><creatorcontrib>Appelbaum, Paul S.</creatorcontrib><title>Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial</title><title>Schizophrenia bulletin</title><addtitle>Schizophr Bull</addtitle><description>Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols.</description><subject>Adult and adolescent clinical studies</subject><subject>Biological and medical sciences</subject><subject>Clinical Trials as Topic - standards</subject><subject>Cognition Disorders - diagnosis</subject><subject>Cognition Disorders - psychology</subject><subject>Comprehension</subject><subject>Decision Making</subject><subject>Female</subject><subject>Humans</subject><subject>Informed Consent - psychology</subject><subject>Informed Consent - standards</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mental Competency</subject><subject>Middle Aged</subject><subject>Multimedia</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopathology. Psychiatry</subject><subject>Psychoses</subject><subject>Regular</subject><subject>Research Subjects - psychology</subject><subject>Schizophrenia</subject><subject>Schizophrenia - diagnosis</subject><subject>Schizophrenia - therapy</subject><subject>Schizophrenic Psychology</subject><subject>Severity of Illness Index</subject><issn>0586-7614</issn><issn>1745-1701</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><recordid>eNqFkc2L1TAUxYMoznN06VaCoLipk6RJmroQ5OEXjB_MjLgMN2lq80ibZ9IKzl9vHn2MHxtXN9z8cnIOB6GHlDynpK3Psh3MEs6yGSlXt9CGNlxUtCH0NtoQoWTVSMpP0L2cd4RQ3kp2F51Qxbggkm5Q_LCE2Y-u84C3ccpumnEfE75w2UGyA_YT_uziPjj81c8DvrSDv477IbmpvICpwx9jGiHgy8XsnJ3zCwz4ouzj6K9dd9CcUwyhHK-Sh3Af3ekhZPfgOE_Rlzevr7bvqvNPb99vX51XljdirmzrlFOdqR2RwHtwnWAMFDMCuoZ2LTBTU8pAGAXGmN5wwoTqBeu5ccSR-hS9XHX3iynpbMmVIOh98iOknzqC13_fTH7Q3-IPzWQra8mKwNOjQIrfF5dnPfpsXQgwubhkLZtaSSZoAR__A-7ikqYSTjNWi5q3VBSoWiGbYs7J9TdOKNGHHvXao157LPyjP-3_po_FFeDJEYBsIfQJJuvzDceo5KRWhxjPVi4u-__8-QsKabjC</recordid><startdate>20090701</startdate><enddate>20090701</enddate><creator>Jeste, Dilip V.</creator><creator>Palmer, Barton W.</creator><creator>Golshan, Shahrokh</creator><creator>Eyler, Lisa T.</creator><creator>Dunn, Laura B.</creator><creator>Meeks, Thomas</creator><creator>Glorioso, Danielle</creator><creator>Fellows, Ian</creator><creator>Kraemer, Helena</creator><creator>Appelbaum, Paul S.</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20090701</creationdate><title>Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial</title><author>Jeste, Dilip V. ; Palmer, Barton W. ; Golshan, Shahrokh ; Eyler, Lisa T. ; Dunn, Laura B. ; Meeks, Thomas ; Glorioso, Danielle ; Fellows, Ian ; Kraemer, Helena ; Appelbaum, Paul S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-c9e8e8db3e06a4faed522a82b5ad71d9a2b3112a5b8abbbfb40258f52f4be0e03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult and adolescent clinical studies</topic><topic>Biological and medical sciences</topic><topic>Clinical Trials as Topic - standards</topic><topic>Cognition Disorders - diagnosis</topic><topic>Cognition Disorders - psychology</topic><topic>Comprehension</topic><topic>Decision Making</topic><topic>Female</topic><topic>Humans</topic><topic>Informed Consent - psychology</topic><topic>Informed Consent - standards</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mental Competency</topic><topic>Middle Aged</topic><topic>Multimedia</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopathology. 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Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>18245061</pmid><doi>10.1093/schbul/sbm148</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult and adolescent clinical studies Biological and medical sciences Clinical Trials as Topic - standards Cognition Disorders - diagnosis Cognition Disorders - psychology Comprehension Decision Making Female Humans Informed Consent - psychology Informed Consent - standards Male Medical sciences Mental Competency Middle Aged Multimedia Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Psychoses Regular Research Subjects - psychology Schizophrenia Schizophrenia - diagnosis Schizophrenia - therapy Schizophrenic Psychology Severity of Illness Index |
title | Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial |
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