Patient & Caregiver Reported Outcomes (PCRO) Core

项目总结 目前有500多万美国人患有阿尔茨海默病(AD)或AD相关痴呆症(AD/ADRD)。 令人痛苦的症状和在护理环境之间的频繁过渡随着疾病的发展而增加。家庭 照顾者也会经历不利的后果。嵌入医疗保健领域的实用临床试验(EPCTS) 需要系统(HCS)来加速将循证干预措施转化为符合以下条件的人 痴呆症(PWD)及其照顾者。为了实现这一更大的目标，针对痴呆症患者和 需要使用照顾者报告结果(PCRO)测量结果， 症状苦恼、生活质量和照顾者经历。然而，概念和方法上的差距仍然存在。 在制定AD/ADRD PCRO时，方法障碍限制了用于ePCT的数据收集。这个 U54申请的总体目标是建立国家老龄研究所(NIA)AD/ADRD HCS 合作。在AD/ADRD合作实验室内，患者和照顾者的首要目标 报告结果(PCRO)的核心是开发和支持与残疾患者和照顾者相关的PCRO的使用， 与行政部门和其他AD/ADRD合作实验室核心和团队合作。PCRO CORE将由Laura Hanson博士领导，她结合了PWD临床试验和他们的护理人员的经验 在衡量严重疾病的质量和结果方面拥有广泛的专业知识。PCRO核心成员拥有 在临床老年病和痴呆症护理流程、痴呆症PCRO、测量科学、卫生方面的专业知识 PWD及其照顾者的差异、大型数据集以及用于实际试验和演示的数据捕获 项目。它们将达到以下具体目标：目标1.合成证据并创建可搜索的 AD/ADRD临床结果评估库(COA)，包括患者报告的结果(PRO)， 照顾者报告的结果(CRO)、观察者报告的结果(ObsRO)、绩效结果(Perfos)、 和临床医生报告的结果(ClinRO)与ePCT和示范项目相关，以改善护理和 残障人士及其照顾者的健康结果；目标2.界定和传播最佳做法， 用于AD/ADRD COA的高质量数据收集系统，可在电子健康记录中捕获 用于技术/数据核心的(EHR)、登记册和行政数据库；目标3.提供专家 关于AD/ADRD COAs的测量和研究应用到AD/ADRD的指导和咨询 协作性试点项目领导人和初级职业发展奖获得者以及NIA资助的调查人员 领先的ePCT专注于残障人士及其照顾者。影响：NIA AD/ADRD HCS合作实验室 响应ePCT的迫切需要，以改善护理和结果。PCRO核心将填补当前的关键 测量和数据收集系统中的差距，以获取对PWD最重要的结果，其 护理者和提供医疗保健的临床医生。

PROJECT SUMMARY Over five million Americans currently live with Alzheimer's disease (AD) or an AD-related dementia (AD/ADRD). Distressing symptoms and frequent transitions between care settings increase over the illness trajectory. Family caregivers also experience adverse outcomes. Pragmatic clinical trials embedded (ePCTs) in healthcare systems (HCS) are needed to accelerate the translation of evidence-based interventions for persons with dementia (PWD) and their caregivers. To accomplish this larger goal, dementia-specific methods in patient and caregiver reported outcome (PCRO) measurement are required to measure outcomes such as function, symptom distress, quality of life, and caregiver experience. However, conceptual and methodologic gaps remain in development of AD/ADRD PCROs, and methodologic barriers constrain data collection for use in ePCTs. The overarching objective of this U54 application is to establish the National Institute on Aging (NIA) AD/ADRD HCS Collaboratory. Within the AD/ADRD Collaboratory, the overarching objective of the Patient & Caregiver Reported Outcomes (PCRO) Core is to develop and support use of PCROs relevant to PWD and caregivers, working in collaboration with Administration and other AD/ADRD Collaboratory Cores and Teams. The PCRO Core will be led by Dr. Laura Hanson, who combines experience in clinical trials for PWD and their caregivers with extensive expertise in measuring quality and outcomes in serious illness. PCRO Core members have expertise in clinical geriatrics and dementia care processes, dementia PCROs, measurement science, health disparities for PWD and their caregivers, large datasets, and data capture for pragmatic trials and demonstration projects. They will meet the following Specific Aims: Aim 1. To synthesize evidence and create a searchable library of AD/ADRD Clinical Outcome Assessments (COAs), including patient-reported outcomes (PROs), caregiver-reported outcomes (CROs), observer-reported outcomes (ObsROs), performance outcomes (PerfOs), and clinician-reported outcomes (ClinROs) relevant to ePCTs and demonstration projects to improve care and health outcomes for PWD and their caregivers; Aim 2. To define and disseminate best practices for efficient, high-quality data collection systems for AD/ADRD COAs that can be captured in electronic health records (EHRs), registries, and administrative databases for use in the Technical/Data Core; Aim 3. To provide expert guidance and consultation on the measurement and research application of AD/ADRD COAs to AD/ADRD Collaboratory pilot project leaders and junior career development awardees, as well as NIA-funded investigators leading ePCTs focused on PWD and their caregivers. IMPACT: The NIA AD/ADRD HCS Collaboratory is responsive to an urgent need for ePCTs to improve care and outcomes. The PCRO Core will fill current critical gaps in measurement and data collection systems to capture the outcomes most significant to PWD, their caregivers, and the clinicians who provide their healthcare.