Parkinsons disease and research consent capacity

描述(由申请人提供)：指导对帕金森氏病(PD)患者独特需求敏感的循证护理的研究努力能否成功，取决于有效地将PD患者纳入研究对象。然而，帕金森病引起的值得研究的问题也是该研究面临伦理挑战的原因：进行性认知障碍。这个项目将了解认知和神经精神障碍对患者做出研究登记决定的能力的影响。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的采访。访谈将使用标准化的决策能力访谈工具和认知评估来收集研究同意能力数据。我们将研究帕金森氏病患者能力损害的严重程度的性质和这些损害的模式，以检查能力损害如何作为帕金森氏病总体认知损害的函数变化，并将这种表现与认知正常的老年人进行比较。我们还将考察帕金森患者在决策能力方面的临床意义：理解、欣赏、推理和选择。为了实现这一点，我们将有专家评分员来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归类为有能力同意的程度，以及帕金森氏症临床严重程度的衡量标准与丧失同意能力的风险之间的关系有多好。最后，我们将考察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，这个项目的三个目标将向临床医生、研究人员、患者和家庭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所做的决定。 公共卫生相关性：指导对帕金森氏病(PD)患者独特需求敏感的循证护理的研究努力能否成功，取决于有效地将PD患者纳入研究对象。然而，帕金森病引起的值得研究的问题也是该研究面临伦理挑战的原因：进行性认知障碍。这个项目将了解认知和神经精神障碍对患者做出研究登记决定的能力的影响。

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.