Predicting post-transplant mortality and global functional health based on pre-transplant functional status in liver transplantation

基于肝移植中移植前功能状态预测移植后死亡率和整体功能健康

• 批准号: 10423506
• 负责人: Jennifer C. Lai
• 金额: $ 30.11万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10423506
• 关键词: Address; Administrative Supplement; Adopted; Adoption; American; Ascites; Assessment tool; Award; COVID-19; COVID-19 pandemic; Caring; Cessation of life; Cirrhosis; Clinical; Communities; Complement; Development; Diagnosis; Diagnostic; Elderly; Emergency medical service; Endoscopy; Enrollment; Ensure; Equilibrium; Esophageal Varix; Evaluation; Foundations; Gastroenterology; Guidelines; Hand Strength; Health; Hepatology; Hospitalization; Image; Infrastructure; Life; Liver; Liver diseases; Malignant neoplasm of liver; Malnutrition; Measures; Medical; Modality; Muscular Atrophy; Outcome; Parents; Participant; Patient Self-Report; Patients; Performance; Performance Status; Persons; Phase; Physical Function; Physiological; Quality of life; Reporting; Research; Risk; Risk Factors; Services; Societies; Standardization; Surveys; Telemedicine; Testing; Time; Transplant Recipients; Transplantation; United States Centers for Medicare and Medicaid Services; Visit; Waiting Lists; Woman; adverse outcome; base; chronic liver disease; clinical decision-making; clinical phenotype; clinical practice; cohort; disability; ethnic minority population; flexibility; frailty; functional status; health care service utilization; indexing; instrument; liver transplantation; mortality; novel; pandemic disease; patient oriented; post-transplant; programs; racial and ethnic; response; stressor; tool; tool development; transplant centers; video visit; virtual; waiver

PROJECT SUMMARY Cirrhosis leads to the insidious effects of muscle wasting and malnutrition that have come to be known in the hepatology community as “frailty”, adapting the geriatric construct of a state of decreased physiological reserve and increased vulnerability to stressors. We developed the novel Liver Frailty Index (LFI) using tests of physical function (grip strength, chair stands, balance) in 2017 to standardize assessment of frailty in patients with cirrhosis and demonstrated its value in predicting adverse outcomes including death, healthcare utilization, and disability. Since its development, many hepatology/ transplant centers globally have adopted the LFI in their in-person evaluations of liver transplant patients. National guidelines by the American Society of Transplantation (2019) and American Association for the Study of Liver Diseases have formally endorsed routine frailty assessment in cirrhosis patients using standardized metrics, such as the LFI. But in the face of the coronavirus disease 2019 (COVID-19) pandemic, the clinical landscape shifted dramatically from in-person visits to telemedicine. Use of telemedicine increased by 4000% among patients with chronic liver diseases within the first 2 weeks of the pandemic, with 98% of U.S. liver transplant programs reporting using telemedicine for all phases of transplant care. Telemedicine has proven to be highly acceptable by both patients and clinicians, suggesting that even as in-person visits resume with control of the pandemic, telemedicine will continue to complement—if not dominate—in-person care provided in hepatology. This raises a new (and unforeseen) unmet need in transplant practice for the development of standardized frailty tools to capture the frailty construct in patients with cirrhosis that can be administered entirely virtually. In this application, we aim to address this unmet need by deriving a novel composite index that can be administered entirely virtually, called the “TeLeFI”, and evaluate the association between the TeLeFI and clinical outcomes including hospitalizations and waitlist mortality. We will leverage our multi-center Functional Assessment in Liver Transplantation (FrAILT) Study infrastructure to assess frailty and frailty-related components (e.g., physical function, performance status, disability) virtually using a battery of established instruments that can then be evaluated for inclusion in the TeLeFI. This objective fits squarely within the original scope of the parent award (R01 AG059183), which is to investigate the association between frailty and transplant-related outcomes in patients with cirrhosis, but will achieve a new research objective to derive this virtual frailty assessment tool. These aims will serve as the foundation for a subsequent R01 proposal to: 1) validate the TeLeFI for the prediction of waitlist outcomes in an adequately powered cohort (using our existing multi-center FrAILT Study infrastructure) and 2) investigate the association between TeLeFI and outcomes after liver transplantation.

项目摘要 肝硬化会导致肌肉浪费和营养不良的阴险作用，在 肝病学界是“脆弱”，适应了改善的物理储备状态的老年结构 并增加了压力源的脆弱性。我们使用的测试开发了新颖的肝脏脆弱指数（LFI） 2017年身体功能（握力强度，椅子架，平衡），以标准化患者的脆弱评估 肝硬化，并证明了其在预测包括死亡，医疗保健在内的不良结果方面的价值 利用和残疾。自从其发展以来，全球许多肝病学/移植中心已经采用 LFI在对肝移植患者的面对面评估中。美国学会的国家准则 移植（2019年）和美国肝病研究协会已正式认可 使用标准化指标（例如LFI）对肝硬化患者进行常规脆弱评估。但面对 2019年冠状病毒病（Covid-19）大流行，临床景观从面对面急剧转移 参观远程医疗。在慢性肝病患者中，远程医疗的使用增加了4000％ 在大流行的前2周内，有98％的美国肝脏移植计划报告使用 远程医疗用于移植护理的所有阶段。远程医疗已被证明是高度可接受的 患者和临床医生表明，即使面对面的访问简历控制了大流行， 远程医疗将继续完成（如果不主导）肝病学提供的人类护理。这加剧了 在移植实践中，一种新的（不可预见的）未满足的需求，以开发标准化的脆弱工具 在肝硬化患者中捕获脆弱的构造，可以完全使用。在这个 应用程序，我们旨在通过得出可以管理的新型复合指数来满足这种未满足的需求 实际上，完全称为“ Telefi”，并评估Telefi与临床结果之间的关联 包括住院和候补名单死亡率。我们将利用我们的多中心功能评估 肝移植（Frailt）研究基础设施，以评估脆弱和脆弱的组件（例如， 实际功能，性能状态，残疾）实际上使用一系列已建立的工具可以 然后评估包含在Telefi中。这个目标完全适合父母的原始范围 奖项（R01 AG059183），这是为了调查脆弱与移植有关的关联 肝硬化患者的结果，但将实现一个新的研究目标来获得这种虚拟的脆弱性 评估工具。这些目标将作为随后的R01提案的基础：1）验证 电视节目预测候补列表中的结果（使用我们现有的多中心） 脆弱的研究基础设施）和2）调查肝后电信与结果之间的关联 移植。