Adherence & Health Outcomes after Liver Transplantation

描述（由申请人提供）：本R01申请的目的是确定患者因素对肝移植（LTX）后依从性和健康结果的影响程度。移植是终末期肝病患者生存的唯一选择；需求远远超过供应，但很少有人知道哪些患者从手术中获益最多。在普通医学和其他移植患者群体中，治疗依从性与健康结果之间存在明显的联系。确定哪些LTX患者有不依从性和次优健康结果的风险是临床医生和重大公共卫生问题的持续困境；如果做不到这一点，医疗系统和社会将付出高昂的代价。拟议的研究将是第一个已知的对多方面LTX方案依从性的前瞻性研究。这项纵向研究的具体目的是：(1)前瞻性地描述txp后第一年对药物服用、预约遵守和推荐生活方式改变的依从性，并确定潜在的依从性轨迹类别；2)确定依从性差异背后的显著个体和环境因素，并预测健康结果。第一年将通过访谈、电子药物监测器和医疗记录审查来跟踪依从性；在移植后1-2个月、6个月和12个月，通过自我报告测量和访谈评估患者的个体和环境因素；在剩余的研究期间，将通过审查医疗记录来跟踪发病率和其次的死亡率。本研究将与匹兹堡大学医学中心的Thomas E. Starzl研究所合作进行；所有在移植后急性期存活下来的成年受者都有资格。招聘将在两年半的时间内进行，预计样本量约为300名受聘人员。该项目的长期目标是为移植临床医生制定指南，以确定移植前或移植后早期有不依从性和亚理想健康结果风险的患者，进行针对性的患者特异性干预，以最大限度地提高LTX的效益。这项研究的应用将成为显著提高国家保护和保持移植人群健康能力的基础。

DESCRIPTION (provided by applicant): The goal of this R01 application is to determine the extent to which patient factors impact on adherence and health outcomes after liver transplantation (LTX). Transplantation is the only option for survival of end stage liver disease; demand far exceeds supply yet little is known about which patients benefit most from the procedure. There are clear links between treatment adherence and health outcomes both in general medicine and in other transplant patient populations. Determining which LTX patients are at risk of non-adherence and suboptimal health outcomes is an ongoing dilemma for clinicians and a significant public health issue; failure to do so is costly to the healthcare system and society. The proposed research will be the first known prospective study of adherence to the multifaceted LTX regimen. Specific aims of this longitudinal study are to 1) prospectively characterize adherence to medication taking, appointment keeping, and recommended lifestyle changes over the first post-txp year and identify latent classes of adherence trajectories; 2) determine salient individual and environmental factors that underlie variation in adherence and predict health outcomes. Adherence will be tracked with interviews, electronic medication monitors, and medical records review over the first year; individual and environmental patient factors will be assessed with self report measures and interviews at 1-2, 6, and 12 months post-transplant; morbidity and, secondarily, mortality will be tracked with medical records review over the remainder of the study period. This study will be conducted in collaboration with the Thomas E. Starzl Institute, at the University of Pittsburgh Medical Center; all adult recipients who survive the acute post-transplant period will be eligible. Recruitment will occur over a 2.5 year period and sample size is projected to be approximately 300 recipients. The long-term goal of this project is to develop guidelines for transplant clinicians to identify patients prior to or early after transplantation who are at risk of non-adherence and sub-optimal health outcomes for targeted patient-specific interventions to maximize benefit of LTX. The application of this research would serve as the basis to advance significantly the nation's capacity to protect and preserve health in transplant populations.