CAPACITY TO CONSENT TO RESEARCH ON PSYCHOSIS

同意精神病研究的能力

• 批准号: 6826834
• 负责人: Barton W. Palmer
• 金额: $ 31.14万
• 依托单位: VETERANS MEDICAL RESEARCH FDN/SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6826834
• 关键词: awareness; behavioral /social science research tag; choice; clinical research; decision making; human middle age (35-64); human old age (65+); human subject; informed consent; longitudinal human study; mental disorder diagnosis; mental health education; mood disorders; psychological aspect of aging; psychological tests; psychosis; schizophrenia; short term memory

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.

先前的研究（主要是年轻样本）确定，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，患者之间也存在这种能力水平的巨大差异。 虽然很少有关于老年精神病患者决策能力（及其增强）的研究，但老年患者在评估参与特定研究方案的风险-受益比时可能需要考虑更复杂的因素，但也可能部分削弱了理解，欣赏和推理这些因素的能力。 此外，虽然知情同意在理想情况下被视为一个持续的过程，在整个患者参与的研究登记，有很少的研究决策能力可能会随着时间的推移波动的程度。 拟议的研究旨在帮助填补这些空白。 受试者将包括152例年龄≥ 50岁的精神分裂症（n=76）或伴有精神病特征的心境障碍（n=76）患者，这些患者正在考虑参与三种非典型抗精神病药物的随机纵向比较。 所有受试者均将在基线时接受决策能力、精神症状严重程度、疾病洞察力/意识和特定认知能力的标准化评估。 为了检查患者从多次学习试验中获益的能力，每次访视时将连续评估三次决策能力。 在这三次会话内决策能力评估之间，将呈现患者在先前试验中难以理解的任何信息。 将在1周后重新进行决策能力测量，以确定重测信度，并在3个月、1年和2年随访评价时重复所有评估（认知成套测验除外，认知成套测验将是基线成套测验的较短版本，针对预期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）内的能力水平将与特定的认知技能、精神症状和洞察力水平差异相关。 我们还希望，患者的决策能力将显着提高会议内多次介绍的材料。 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自知力缺陷和精神症状严重程度的平行变化。