Evaluating Cognitive Function Cost Utility and Outcomes after Liver Transplant

描述（由申请人提供）：肝移植最初的挑战是证明成功的技术结果和可接受的长期生存。既然肝移植是一种相对常见的手术，可以为接受者提供许多年的生命，那么必须高度关注移植后认知功能、健康相关生活质量和成本效用的改善。由于生存率的“天花板效应”和移植排斥反应的“底部效应”的实现，必须利用肝移植的额外结果测量来衡量干预措施的效果。确定影响认知功能、生活质量和成本效用的因素对实现这一目标至关重要。本研究项目的具体目的是：(1)前瞻性评估肝移植前后认知功能及肝移植后认知功能改变的临床相关因素；(2)检验成人肝移植受者移植前后人口学特征、危险因素、临床事件与功能表现、健康相关生活质量、焦虑和抑郁症状以及整体健康之间关系的性质和强度；(3)前瞻性评估和验证肝移植环境中，移植前后健康状况的测量可用于成本-效用分析。肝移植候选人和受者将被要求完成一系列与健康相关的生活质量评估表格，并在不同的时间间隔进行认知功能测试，以测量随时间变化的轨迹及其与多种术前临床危险因素、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，以改善结果并协助临床医生做出决策，就像目前使用的影响生存和并发症因素的数据一样。这些分析的结果将提示患者护理途径的改变和资源的应用，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付款人的决定，因为它将更全面地了解与这种昂贵治疗有关的个人和群体患者的预期结果。

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.