Evaluating Cognitive Function Cost Utility and Outcomes after Liver Transplant

描述(由申请人提供)：肝移植的最初挑战是证明成功的技术结果和可接受的长期存活。既然肝移植是一种相对常见的手术，可以为受者提供多年的生命，那么必须高度关注移植后认知功能、与健康相关的生活质量和成本效益的改善。由于实现了存活率的“天花板效应”和移植物排斥反应的“底板效应”，必须使用肝移植的其他预后措施来衡量干预措施的效果。确定影响认知功能、生活质量和成本效益的因素是实现这一目标的关键。这项研究项目的具体目标是：(1)前瞻性地评估移植前后的认知功能和肝移植后认知功能改变的临床相关性；(2)测试移植前后的人口统计学特征、风险因素和临床事件与成年肝移植受者的功能表现、健康相关的生活质量、焦虑和抑郁症状以及整体健康之间的关系的性质和强度；以及(3)前瞻性地评估和验证可用于成本效益分析的肝移植前后的健康状况测量。肝移植候选人和接受者将被要求填写一系列与健康相关的生活质量评估表，并在不同的时间间隔接受认知功能测试，以衡量随时间的变化轨迹及其与多种术前临床风险因素、围手术期因素和术后事件的关系。这项研究的相关性将是最终确定干预措施以改善结果并帮助临床医生做出决策，就像目前使用的影响生存和并发症的因素的数据一样。这些分析的结果将提示患者护理路径的变化和资源的应用，以有利地影响这些重要的结果变量，就像过去患者管理策略因应并发症发生率和死亡原因而发生变化一样。此外，这些信息可能会影响政策制定者和支付者的决策，因为它将更全面地描述与这种昂贵的治疗相关的个人和患者群体的预期结果。

DESCRIPTION (provided by applicant): The initial challenges in liver transplantation were to demonstrate successful technical outcomes and acceptable long term survival. Now that liver transplantation is a relatively common procedure that provides many life years to the recipient, there must be an intense focus on improvements in cognitive function, health-related quality of life, and cost-utility following transplantation. Due to the achievement of a "ceiling effect" for survival rates and a "floor effect" for graft rejections, additional outcomes measures for liver transplantation must be utilized to measure the effects of interventions. The identification of factors that influence cognitive function, quality of life, and cost-utility is essential to accomplish this goal. The specific aims of this research project are: (1) to prospectively evaluate pre- and post transplant cognitive function and clinical correlates of change in cognitive function following liver transplantation; (2) to test the nature and strength of relationships among pre- and post transplant demographic characteristics, risk factors, and clinical events on functional performance, health-related quality of life, symptoms of anxiety and depression, and overall health in adult liver transplant recipients; and (3) to prospectively assess, and validate in the liver transplantation setting, pre- and post-transplant measures of health status that can be employed in cost- utility analyses. Liver transplant candidates and recipients will be asked to complete a battery of health- related quality of life assessment forms and undergo cognitive function testing at various time intervals to measure the trajectory of change over time and its relationship to multiple pre-operative clinical risk factors, perioperative factors, and post-operative events. The relevance of this research will be the eventual identification of interventions to improve outcomes and to assist clinicians in decision making, much as data on factors that influence survival and complications are employed currently. Findings from these analyses will suggest changes in patient care pathways and the application of resources to influence favorably these important outcome variables, much as patient management strategies have shifted in response to complication rates and causes of mortality in the past. Additionally, this information is likely to influence policy maker and payer decisions, as it will give a more complete picture of anticipated outcomes for individual and groups of patients in relation to this expensive treatment.