Divisions of Neuropsychology and Neuro-oncology, University of Alabama at Birmingham, Birmingham, AL 35294-0017, USA.
J Clin Oncol. 2010 Aug 20;28(24):3844-50. doi: 10.1200/JCO.2009.27.9091. Epub 2010 Jul 19.
To investigate research consent capacity (RCC) in patients with malignant gliomas (MGs) and identify cognitive abilities and clinical factors associated with RCC in MG.
Participants were 22 healthy controls and 26 patients with diagnosed and histologically verified MG. All patients with MG were receiving various combinations of treatment (surgery, radiation, chemotherapy, medication). Both groups were administered a neurocognitive test battery and a standardized RCC measure (Capacity to Consent to Research Instrument [CCRI]). Capacity performance was evaluated across four core consent abilities (choice, appreciation, reasoning, understanding), and categorical capacity impairment ratings (no impairment, mild/moderate impairment, severe impairment) were also identified for individual patients with MG. Stepwise regression analyses identified cognitive predictors of CCRI performance in the MG group.
The MG patient group performed significantly below the control group on the three clinically relevant consent standards (appreciation, reasoning, and understanding). Patients with MG performed equivalently to controls in evidencing a simple research participation choice. Approximately one third of patients with MG showed compromised impairment ratings (mild/moderate impairment or severe impairment) on the three consent abilities. Cognitive measures of phonemic and semantic word fluency predicted performance on the consent standards. Steroid treatment and anticonvulsant use were related to poorer CCRI performance.
A substantial portion of patients with MG after diagnosis show impairments in research consent capacity. Word fluency measures reflecting expressive language and executive function abilities are strongly associated with these consent impairments. This study highlights the importance of careful attention to consent issues when enrolling patients with MG in clinical trials and other research studies.
调查恶性胶质瘤（MG）患者的研究同意能力（RCC），并确定与 MG 患者 RCC 相关的认知能力和临床因素。
参与者包括 22 名健康对照者和 26 名确诊并经组织学证实的 MG 患者。所有 MG 患者均接受了各种治疗（手术、放疗、化疗、药物治疗）的联合治疗。两组均接受了神经认知测试和标准化 RCC 测量（同意研究能力量表[CCRI]）。能力表现评估了四个核心同意能力（选择、欣赏、推理、理解），并对每位 MG 患者进行了分类能力损伤评级（无损伤、轻度/中度损伤、重度损伤）。逐步回归分析确定了 MG 组 CCRI 表现的认知预测因子。
MG 患者组在三个临床相关同意标准（欣赏、推理和理解）上的表现明显低于对照组。MG 患者在表现出简单的研究参与选择时与对照组表现相当。大约三分之一的 MG 患者在三个同意能力上表现出受损的损伤评级（轻度/中度损伤或重度损伤）。语言流畅性认知测试（语音和语义词汇流畅性）预测了同意标准的表现。类固醇治疗和抗惊厥药的使用与较差的 CCRI 表现相关。
MG 患者在确诊后，相当一部分患者表现出研究同意能力受损。反映表达性语言和执行功能能力的词汇流畅性测试与这些同意受损密切相关。本研究强调了在招募 MG 患者参加临床试验和其他研究研究时，应仔细关注同意问题的重要性。
