Division of Bipolar Disorders Research, Department of Psychiatry & Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Division of Bipolar Disorders Research, Department of Psychiatry & Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
J Affect Disord. 2019 Jan 1;242:1-4. doi: 10.1016/j.jad.2018.08.049. Epub 2018 Aug 13.
Identifying correlates of capacity to provide informed consent among individuals with bipolar disorder is essential for patient protection. As part of a clinical trial involving approved, standard treatments, we investigated relationships between clinical characteristics and capacity to provide informed consent in adults with bipolar disorder using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). After administering the MacCAT-CR, continuing participants in the trial were capable of and provided informed consent.
Trained, board-certified psychiatrists administered the MacCAT-CR to potential study participants (N = 50) after they provided informed consent, but prior to initiation of study procedures.
Higher Schedule for Assessment of Positive Symptoms (SAPS) scores were significantly correlated with worse MacCAT-CR Understanding and Appreciation (p < 0.04) subscale scores; lower Hamilton Depression Rating Scale (HDRS) scores and higher Clinical Global Impression-Severity (CGI-S) scores were significantly correlated with worse Reasoning and Understanding subscale scores (p < 0.03); and patients with comorbid substance use disorders (SUD) had better Appreciation and Reasoning subscale scores (p < 0.05).
The MacCAT-CR identifies areas where participants need explanation. However, there is not a predetermined score to indicate understanding of study procedures and therefore input from a trained clinician is needed to determine capacity to provide informed consent.
Our findings suggest that certain measures of illness severity are associated with lower levels of capacity to provide informed consent among adults with bipolar disorder. This study provides important information for clinicians and researchers to consider when obtaining informed consent in this population.
确定双相情感障碍患者知情同意能力的相关因素对于保护患者至关重要。作为涉及已批准标准治疗的临床试验的一部分，我们使用 MacArthur 临床研究能力评估工具（MacCAT-CR）研究了双相情感障碍成年人的临床特征与知情同意能力之间的关系。在进行 MacCAT-CR 后，继续参与试验的患者有能力并提供了知情同意。
经过培训的、具有董事会认证的精神科医生在潜在的研究参与者（N=50）提供知情同意后但在开始研究程序之前对其进行了 MacCAT-CR 评估。
较高的阳性症状评定量表（SAPS）评分与较差的 MacCAT-CR 理解和欣赏（p<0.04）分量表评分显著相关；较低的汉密尔顿抑郁评定量表（HDRS）评分和较高的临床总体印象严重程度（CGI-S）评分与较差的推理和理解分量表评分显著相关（p<0.03）；伴有共病物质使用障碍（SUD）的患者具有更好的欣赏和推理分量表评分（p<0.05）。
MacCAT-CR 确定了参与者需要解释的领域。但是，没有预定的分数来表示对研究程序的理解，因此需要经过培训的临床医生来确定提供知情同意的能力。
我们的研究结果表明，某些疾病严重程度的指标与双相情感障碍成年人的知情同意能力较低有关。这项研究为临床医生和研究人员在该人群中获得知情同意时提供了重要信息。
