CAPACITY TO CONSENT TO RESEARCH ON PSYCHOSIS

先前的研究（主要是年轻人的样本）证实，患有严重精神疾病（如精神分裂症）的患者有决策能力受损的风险，但即使在诊断类别中，患者之间的这种能力水平也存在很大的差异。虽然关于老年精神病患者的决策能力（及其增强）的研究很少，但在评估参与特定研究方案的风险-收益比时，老年患者可能需要考虑一系列更复杂的因素，但对这些因素的理解、欣赏和推理能力也可能部分减弱。此外，虽然知情同意在理想情况下被视为贯穿患者-参与者参加研究的一个持续过程，但很少有关于决策能力随时间波动的程度的研究。这项拟议的研究旨在帮助填补这些空白。研究对象将包括152名年龄在50岁或以上的精神分裂症患者（n=76）或伴有精神病特征的情绪障碍患者（n=76），他们正在考虑参加三种非典型抗精神病药物的随机纵向比较。所有受试者将在基线时进行标准化的评估，包括决策能力、精神症状的严重程度、对疾病的洞察力/意识以及特定的认知能力。为了检查患者从多次学习试验中获益的能力，每次访问时将连续评估三次决策能力。在这三个会议决策能力评估之间，患者在之前的试验中遇到困难的任何信息都将被表示出来。决策能力测试将在一周后重新进行，以建立测试-再测试的信度，所有的评估将在3个月、1年和2年的随访评估中重复进行（除了认知能力测试将是基线测试的短版本，针对那些可能发生变化的认知能力）。我们假设患者在决策的四个特定维度（理解、欣赏、推理和选择证据）中的能力水平与特定的认知技能、精神症状和洞察力水平存在差异。我们也期望患者的决策能力将显著提高，在会议期间多次介绍的材料。我们进一步假设，从基线到3个月、1年和2年随访的能力波动将伴随着洞察力缺陷和精神症状严重程度的平行变化。

Prior research (with predominantly younger samples) established that patients with severe mental illnesses such as schizophrenia are at risk for impaired decision making capacity, yet even within diagnostic categories substantial variability exists among patients in the levels of such capacity. While there has been little research on decision making capacity (and it enhancement) in older psychiatric patients, older patients may have a more complex array of factors to consider in evaluating the risk-benefit ratio of participating in a particular research protocol, yet may also have a partially diminished capacity to understand, appreciate and reason about these factors. Also, while informed consent is ideally viewed as a ongoing process throughout a patient-participant's enrollment in a study, there has been little research on the degree to which decision making capacity may fluctuate over time. The proposed study is designed to help fill these gaps. Subjects will include 152 patients age 50 years or older with schizophrenia (n=76) or mood disorders with psychotic features (n=76) who are considering participation in a randomized longitudinal comparison of three atypical antipsychotic medications. All subjects will be evaluated at baseline with standardized measures of decision making capacity, severity of psychiatric symptoms, insight/awareness of illness, and specific cognitive-abilities. To examine the ability of patients' to profit from multiple learning trials, decision making capacity will be assessed three times in succession at each visit. Between each of the these three within session decision-making capacity assessments, any information that patients had difficulty with on the preceding trial will be represented. The decision making capacity measure will be re- administered one-week later to establish test-retest reliability, and all of assessments will be repeated at 3-month, 1-year, and 2-year followup evaluations (except that the cognitive battery will be a shorter version of the baseline battery, targeting those cognitive abilities which might be expected to change). We hypothesize that patients' levels of capacity within four specific dimensions of decision making (understanding, appreciation, reasoning, and evidence of a choice) will be differentially associated with specific cognitive skills, psychiatric symptoms, and levels of insight. We also expect that patients' decision making capacity will be significantly improve within sessions by multiple presentations of the material. We further hypothesize that fluctuations in capacity from baseline to the 3-month, 1-year, and 2-year followups will be accompanied by parallel changes in insight deficits and severity of psychiatric symptoms.