Trajectories of Medication Adherence in Pediatric Organ Transplantation and Their Relationship to Posttransplant Health Outcomes

儿科器官移植中的药物依从性轨迹及其与移植后健康结果的关系

• 批准号: 10057497
• 负责人: Michael KILLIAN
• 金额: $ 20.83万
• 依托单位: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-08 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10057497
• 关键词: Acute; Address; Adherence; Adolescence; Adolescent; Area; Behavioral; Biological Markers; Blood; Characteristics; Child; Childhood; Chronic Disease; Classification; Clinical Decision Support Systems; Confidence Intervals; Country; Data; Decision Making; Development; Electronic Health Record; Emergency Situation; Family; Frequencies; Future; Goals; Growth; Health; Healthcare; Heart Transplantation; Heterogeneity; Hospitalization; Immunosuppressive Agents; Individual; Intervention; Intervention Studies; Kidney Transplantation; Knowledge; Link; Measures; Medical center; Modeling; Monitor; Nature; Organ; Organ Transplantation; Outcome; Patient Care; Patient Noncompliance; Patients; Pattern; Pharmaceutical Preparations; Predictive Factor; Research; Risk; Risk Factors; Sampling; Solid; Surveys; Tacrolimus; Techniques; Testing; Time; Transplant Recipients; Transplantation; Uncertainty; United Network for Organ Sharing; United States Dept. of Health and Human Services; Variant; clinical care; clinical development; experience; indexing; insight; liver transplantation; medication compliance; mortality; novel; pediatric patients; post-transplant; programs; public health relevance; recruit; research and development; retransplantation; therapy development; tool; transplant centers

Trajectories of Medication Adherence in Pediatric Organ Transplantation and Their Relationship to Posttransplant Health Outcomes Project Summary / Abstract Non-adherence to immunosuppressive medication remains one of the most significant predictors of late acute rejection (LAR), increased number and frequency of hospitalizations, need for retransplantation, and even mortality in pediatric transplant patients. Medication Level Variability Index (MLVI) has been validated as a measure of medication adherence and calculated from medication blood levels obtained during routine clinical care of these patients. However, few studies have examined longitudinal trajectories of adherence to immunosuppressive medication and possible differences in posttransplant outcomes. Further research is necessary to understand variation in trajectories of medication adherence in pediatric organ transplantation with Growth Mixture Modeling (GMM) proposed as a novel statistical approach. We propose to address these gaps in knowledge by examining trajectories of MLVI values in data collected from one of the largest pediatric transplant centers in the country. Patient and administrative data from the United Network for Organ Sharing (UNOS, U.S. Department of Health and Human Services) will be electronically linked with patient electronic health records (EHR). We will use latent growth curve analysis and a novel GMM three-step approach to this analytic technique to 1) examine the association between patient and familial risk factors and long-term posttransplant health outcomes, 2) estimate the functional form medication growth trajectories, 3) examine the number of classes of growth in MLVI values and identify patients with similar classes, and 4) examine association between classes of growth and both patient- and family-level predictors and posttransplant health outcomes. Understanding the patient- and family-level predictors of classes of individual growth will inform assessment and intervention efforts as to which patients and families may be greatest risk for non-adherence over time and poor posttransplant outcomes. Results aim to be applicable to national pediatric organ transplant centers, other areas of chronic illness in childhood and adolescence, and the basis for future research and development of interventions.

儿科器官移植中药物依从性的轨迹及其与 移植后健康结果 项目概要/摘要 不坚持使用免疫抑制药物仍然是晚期急性发作最重要的预测因素之一 排斥反应（LAR）、住院次数和频率增加、需要再移植，甚至 儿科移植患者的死亡率。药物水平变异指数 (MLVI) 已被验证为 药物依从性的测量，并根据常规临床期间获得的药物血液浓度计算 照顾这些病人。然而，很少有研究考察坚持的纵向轨迹。 免疫抑制药物和移植后结果可能存在的差异。进一步的研究是 有必要了解儿科器官移植中药物依从性轨迹的变化 增长混合模型（GMM）被提出作为一种新颖的统计方法。我们建议解决这些问题 通过检查从最大儿科中心之一收集的数据中的 MLVI 值轨迹来弥补知识差距 该国的移植中心。来自器官共享联合网络的患者和管理数据 （UNOS，美国卫生与公众服务部）将与患者电子设备进行电子连接 健康记录（EHR）。我们将使用潜在增长曲线分析和新颖的 GMM 三步法来实现这一点 分析技术 1) 检查患者和家族危险因素与长期风险因素之间的关联 移植后健康结果，2) 估计功能形式药物生长轨迹，3) 检查 MLVI 值增长的类别数量并识别具有相似类别的患者，以及 4) 检查 生长类别与患者和家庭层面的预测因素以及移植后健康之间的关联 结果。了解患者和家庭层面的个人成长类别预测因素将提供信息 评估和干预工作，以确定哪些患者和家庭可能是不依从的最大风险 随着时间的推移和移植后效果不佳。结果旨在适用于全国儿科器官移植 中心、儿童和青少年慢性病的其他领域以及未来研究和治疗的基础 干预措施的发展。