Adherence & Health Outcomes after Liver Transplantation

描述（由申请人提供）：本R 01申请的目标是确定患者因素对肝移植（LTX）后依从性和健康结局的影响程度。移植是终末期肝病生存的唯一选择;需求远远超过供应，但对哪些患者从手术中获益最多知之甚少。在普通医学和其他移植患者人群中，治疗依从性和健康结果之间存在明显的联系。确定哪些LTX患者存在不依从性和次优健康结果的风险是临床医生的一个持续困境，也是一个重大的公共卫生问题;如果不这样做，医疗保健系统和社会的成本将很高。这项拟议的研究将是第一个已知的关于坚持多方面LTX方案的前瞻性研究。这项纵向研究的具体目的是：1）前瞻性地描述TXP后第一年内服药依从性、预约保持和建议的生活方式改变，并确定依从性轨迹的潜在类别; 2）确定依从性变化的突出个体和环境因素，并预测健康结果。在第一年内，将通过访谈、电子药物监测器和病历审查来跟踪依从性;在移植后1-2、6和12个月，将通过自我报告措施和访谈来评估个体和环境患者因素;在研究期间的剩余时间内，将通过病历审查来跟踪发病率，其次是死亡率。本研究将与托马斯E.匹兹堡大学医学中心的Starzl研究所;所有在移植后急性期存活的成年受者都有资格。 招募将在2.5年内进行，预计样本量约为300名接受者。该项目的长期目标是为移植临床医生制定指南，以识别移植前或移植后早期存在不依从性和次优健康结局风险的患者，以便针对特定患者进行干预，以最大限度地提高LTX的获益。 这项研究的应用将作为基础，大大提高国家保护和维护移植人群健康的能力。

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.