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
University of California, San Diego, USA.
Schizophr Bull. 2009 Jul;35(4):719-29. doi: 10.1093/schbul/sbm148. Epub 2008 Jan 31.
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.
长期以来,印刷的、基于文本的同意书的局限性已有文献记载,对于决策能力受损风险较高的人群,如精神分裂症患者,可能尤其成问题。我们对多媒体同意程序与常规同意程序(辅以10分钟的对照视频演示)的有效性进行了随机对照比较,以此作为提高128名中年及老年精神分裂症患者和60名健康对照受试者理解能力的一种手段。主要结局指标是参与一项(假设的)临床药物试验的明显决策能力(理解、领会、推理和选择表达),使用麦克阿瑟临床研究能力评估工具(MacCAT-CR)和加利福尼亚大学圣地亚哥分校(UCSD)同意能力简要评估(UBACC)进行测量。MacCAT-CR和UBACC由对同意条件不知情的研究助理进行管理。额外的评估包括精神病理学和认知功能的标准化测量。与常规同意条件下的患者相比,接受多媒体同意的精神分裂症患者在UBACC以及MacCAT-CR理解和选择表达子量表上的得分显著更高,并且与常规同意条件下的患者相比(根据几个先前确立的标准进行分类),被归类为有能力同意的可能性显著更大。在健康受试者中,同意条件的影响很小。这些发现表明,多媒体同意程序可能是一种有价值的同意辅助手段,在招募决策能力受损风险较高的参与者时,尤其是对于复杂和/或高风险的研究方案,应考虑使用。