Parkinsons disease and research consent capacity

描述（由申请人提供）：指导对帕金森病（PD）患者独特需求敏感的循证护理的研究工作的成功取决于PD患者作为研究对象的有效入组。然而，帕金森氏症引起的值得研究的问题，同时也是该研究面临伦理挑战的原因：进行性认知障碍。该项目将了解认知和神经精神障碍对患者做出研究注册决定的能力的影响。这项研究将包括对90名帕金森患者和30名认知正常的老年人进行家庭面对面访谈。访谈将使用标准化的决策能力访谈工具和认知评估收集研究同意能力数据。我们将研究帕金森病患者能力障碍严重程度的本质以及这些障碍的模式，以研究帕金森病患者能力障碍作为整体认知障碍的功能是如何变化的，并将这种表现与认知完好的老年人进行比较。我们还将研究帕金森患者在决策能力方面表现的临床意义：理解，欣赏，推理和选择。为了实现这一目标，我们将让专家评估师判断患者是否有足够的能力，这将使我们能够检查给定的能力评分将患者分类为有能力同意的程度，以及帕金森病的临床严重程度与丧失同意能力的风险之间的关系有多好。最后，我们将研究人格特征如何影响同意能力和是否参加早期研究的决定。总而言之，该项目的三个目标将向临床医生、研究者、患者和家属展示帕金森病患者的认知和人格问题如何影响患者做出具有道德挑战性的决定的能力，以及他们做出的决定。

DESCRIPTION (provided by applicant): The success of research efforts to guide evidence-based care that is sensitive to the unique needs of Parkinsons disease (PD) patients rests on the effective enrollment of PD patients as research subjects. Yet the very problems caused by PD that warrant research are also the cause of ethical challenges to that research: progressive cognitive impairments. This project will understand the impact of cognitive as well as neuropsychiatric impairments on a patient's ability to make a research enrollment decision. This study will involve in-home, face-to-face interviews with 90 Parkinsons patients and 30 cognitively normal older adults. The interview will gather research consent capacity data using a standardized decisional capacity interview tool as well as cognitive assessments. We will examine the nature of the severity of capacity impairments in persons with Parkinsons disease and the patterns of those impairments to examine how capacity impairments vary as a function of overall cognitive impairment in Parkinsons disease and compare this performance to cognitively intact older adults. We will also examine the clinical significance of Parkinsons patient performance on the measures of the decisional abilities: understanding, appreciation, reasoning and choice. To achieve this, we will have expert raters judge whether the patient has sufficient capacity, which will allow us to examine how well a given ability score classifies a patient as capable of consent and how well measures of the clinical severity of Parkinson's disease associate with the risk of loss of capacity to consent. Finally, we will examine how personality traits affect both the capacity to consent and the decision whether to enroll in early phase research. In sum, the three aims of this project will show clinicians, investigators, patients and families how the cognitive and personality problems seen in persons with Parkinsons disease affect patients' ability to make ethically challenging decisions and the decisions that they make. PUBLIC HEALTH RELEVANCE: The success of research efforts to guide evidence-based care that is sensitive to the unique needs of Parkinsons disease (PD) patients rests on the effective enrollment of PD patients as research subjects. Yet the very problems caused by PD that warrant research are also the cause of ethical challenges to that research: progressive cognitive impairments. This project will understand the impact of cognitive as well as neuropsychiatric impairments on a patient's ability to make a research enrollment decision.