Patient & Caregiver Reported Outcomes (PCRO) Core

项目摘要 目前，超过500万美国人患有阿尔茨海默病（AD）或AD相关痴呆症（AD/ADRD）。 痛苦的症状和护理环境之间的频繁转换随着疾病的发展而增加。家庭 照料者也会经历不良后果。医疗保健中的嵌入式实用临床试验（ePCT） 因此，需要建立一个系统（HCS），以加速对患有糖尿病的人进行循证干预的转化。 痴呆症（PWD）及其护理人员。为了实现这一更大的目标，痴呆症的具体方法， 需要护理者报告结果（PCRO）测量来测量诸如功能的结果， 症状困扰、生活质量和照顾者经验。然而，概念和方法上的差距仍然存在 在开发AD/ADRD PCRO方面，方法障碍限制了用于ePCT的数据收集。的 U 54申请的首要目标是建立国家老龄化研究所（NIA）AD/ADRD HCS 合作实验室在AD/ADRD合作实验室内，患者和护理人员的首要目标是 报告结果（PCRO）核心是开发和支持使用与PWD和护理人员相关的PCRO， 与行政部门和其他AD/ADRD合作实验室核心和团队合作。PCRO 核心将由Laura Hanson博士领导，她结合了PWD及其护理人员的临床试验经验 在衡量严重疾病的质量和结果方面具有广泛的专业知识。PCRO核心成员有 临床老年病和痴呆症护理流程、痴呆症PCRO、测量科学、健康 PWD及其护理人员的差异，大型数据集以及用于实用试验和演示的数据采集 项目它们将实现以下具体目标：目标1。综合证据并创建一个可搜索的 AD/ADRD临床结局评估（COA）库，包括患者报告结局（PRO）， 护理人员报告的结果（CROs）、观察者报告的结果（ObsROs）、表现结果（PerfOs）， 与ePCT和示范项目相关的临床医生报告结局（ClinRO），以改善护理， 残疾人及其照顾者的健康结果;目标2。确定和传播最佳做法， AD/ADRD COA的高质量数据收集系统，可在电子健康记录中获取 （EHR）、登记和管理数据库，用于技术/数据核心;目标3。提供专家 AD/ADRD COA测量和研究应用的指导和咨询 合作实验室试点项目负责人和初级职业发展获奖者，以及国家情报局资助的调查人员 领先的ePCT专注于PWD及其护理人员。影响：NIA AD/ADRD HCS合作实验室 响应对ePCT的迫切需求，以改善护理和结果。PCRO核心将填补目前的关键 衡量和数据收集系统中的差距，以捕捉对残疾人最重要的结果， 护理人员和为他们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.