Holistic Evaluation to Advance Research in Dementia (HEARD): Phased Interdisciplinary Infrastructure Development and Pilot Studies

谢拉·L·莫罗尼 1R21AG007481-01 修订摘要： 对于对个人和家庭重要的领域，缺乏可用的措施 患有阿尔茨海默病(AD)和相关的痴呆症。确实具有临床重要性的可用措施可能包括抽象结构和/或复杂的反应形式(例如，7点Likert类型或数字量表)，这些对痴呆症患者来说并不是最佳的。跨学科的研究人员正在从事以治疗乐观为基础的创新的、以人为中心的干预措施，但受到主要量化负面行为、缺陷和下降的工具的限制，和/或通过测量诸如全球生活质量等广泛的结构。NIH-PROMIS测量显示了标准化的通用数据集的价值，但它们目前没有纳入患者的偏好，也可能没有囊括所有积极的结果。阿尔茨海默病患者将受益于严格的多地点心理社会干预试验，试验使用一系列对变化敏感的强有力的措施，以及随着时间的推移捕捉痴呆症患者良好生活的可修改方面的措施。该项目将为开发、标准化和验证阿尔茨海默病心理社会干预的新成果措施和方法提供基础设施。重点将放在对阿尔茨海默病患者具有临床意义的措施以及捕捉阿尔茨海默病和相关痴呆患者可改变因素的措施上。将优先采取措施，优化对同时存在认知和感觉挑战的人进行心理社会干预的纵向评估。在R21阶段，由阿尔茨海默病患者、研究人员和生物统计学家组成的跨学科指导委员会将召集有重点的专家小组，并与研究人员和临床医生咨询委员会合作。利用以人为中心的设计原则，委员会将确定优先的结果衡量标准，并为新措施、方法和技术的设计和测试创建标准。在R33阶段，将试行确定优先顺序的措施和方法。这些措施将包括自我报告、照顾者知情和观察性措施。这项工作的成果将包括：1)为心理社会干预研究开发和测试新措施的研究指南，以及2)有希望的新措施、方法和技术，可用于更大规模的测试，目标是增加NIHPROMI措施集。这些产品的传播将加强现有的研究基础设施，并加快心理社会干预研究的进展。

Molony, Sheila L 1R21AG007481-01 Revised Abstract: There is a lack of measures available for domains of importance to individuals and families living with Alzheimer’s Disease (AD) and related dementias. Available measures that do have clinical importance may include abstract constructs and/or complex response formats (e.g. 7-point Likert-type or numerical scales) that are not optimal for persons with dementia. Interdisciplinary researchers are engaging in innovative, person-centered interventions grounded in therapeutic optimism but are constrained by instruments that primarily quantify negative behaviors, deficit, and decline, and/or by measuring broad constructs such as global quality of life. The NIH-PROMIS measures demonstrate the value of standardized, common datasets but they do not currently incorporate patient preferences and may not encapsulate the full range of positive outcomes. Persons living with AD would benefit from rigorous, multi-site psychosocial intervention trials using a common portfolio of robust measures sensitive to change and measures that capture modifiable aspects of living well with dementia over time. This project will develop the infrastructure for development, standardization and validation of new outcome measures and methods for psychosocial interventions in AD. Emphasis will be placed on measures that are clinically meaningful to persons living with AD as well as measures that capture modifiable elements of living with AD and related dementias. Measures that optimize longitudinal evaluation of psychosocial intervention for persons with co-occurring cognitive and sensory challenges will be prioritized. In the R21 phase, an interdisciplinary steering council comprised of persons living with AD, researchers and biostatisticians will convene focused expert panels and collaborate with an advisory board of researchers and clinicians. Using the principles of human-centered design, the council will identify priority outcome measures and create standards for design and testing of novel measures, methods, and technologies. In the R33 phase, prioritized measures and methods will be pilot tested. These will include self-report, carer-informed and observational measures. Products of this work will include: 1) Research guidelines for the development and testing of new measures for psychosocial intervention research and 2) Promising new measures, methods and technologies available for larger scale testing with goal of adding to the NIHPROMIS measure set. The dissemination of these products will enhance the existing research infrastructure and accelerate progress in psychosocial intervention research.