Racial and ethnic differences in diabetes treatment and outcomes in US hemodialys

美国血液透析中糖尿病治疗和结果的种族和民族差异

• 批准号: 8783373
• 负责人: JINNIE J. RHEE
• 金额: $ 5.15万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-13 至 2016-08-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8783373
• 关键词: 2,4-thiazolidinedione; Accounting; African American; Antidiabetic Drugs; Cardiovascular system; Cessation of life; Clinical; Cohort Studies; Complications of Diabetes Mellitus; Computerized Medical Record; Cox Proportional Hazards Models; Data; Data Set; Databases; Development; Diabetes Mellitus; Diabetic Foot Ulcer; Diabetic Nephropathy; Dialysis procedure; End stage renal failure; Epidemiology; Ethnic Origin; Ethnic group; Event; Glycosylated hemoglobin A; Health Services; Hemodialysis; Hispanics; Incidence; Information Systems; Intention; Kidney; Kidney Diseases; Knowledge; Linear Regressions; Measures; Metabolic Diseases; Methods; Modeling; Modification; Morbidity - disease rate; Myocardial Infarction; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Observational Study; Oral; Osteomyelitis; Outcome; Patients; Peripheral arterial disease; Pharmaceutical Preparations; Pharmacotherapy; Pneumonia; Population; Provider; Race; Relative Risks; Research; Research Personnel; Research Project Grants; Risk; Services; Skin Tissue; Soft Tissue Infections; Statistical Methods; Stroke; Sulfonylurea Compounds; Techniques; Testing; Thiazolidinediones; Time; Training; Treatment outcome; Work; burden of illness; cardiovascular risk factor; career; comparative effectiveness; compare effectiveness; design; diabetes control; diabetes management; diabetic; effectiveness research; glycemic control; high risk; interest; mortality; primary outcome; public health relevance; racial and ethnic; racial/ethnic difference; research study; skills

DESCRIPTION (provided by applicant): In hemodialysis (HD) patients with diabetes mellitus (DM), the risk of developing diabetes- related complications and mortality is high. However, data on the associations among diabetes control, treatment, and diabetes-related complications in HD patients with DM are extremely limited. In addition, racial and ethnic differences in these relationships have not been documented. Objectives: The objective of this observational study is to assess the relationship among glycemic control, oral antidiabetic drug (OAD) therapy, and both cardiovascular and non-cardiovascular outcomes in HD patients with DM. We will also explore racial and ethnic differences in these associations. Methods: We will use data from the U.S. Renal Data System and electronic medical records of DaVita, Inc., to conduct a retrospective cohort study of patients on HD with diabetes mellitus at a large national provider of dialysis services to examine the associations among HbA1c and various clinical outcomes (Specific Aims 1 and 2). A subset of these patients will be used for a comparative effectiveness study of patients receiving TZD or sulfonylurea monotherapy (Specific Aim 3). For the first two aims, we will use Cox proportional hazards models to assess the associations between HbA1c and time to primary outcomes of interest, and test for effect modification by race and ethnicity by including interaction terms and performing a Wald test. We will further explore contrasts between different racial and ethnic groups upon finding significant interaction terms. For Specific Aim 3, we will compare prevalent and incident users of TZDs to users of sulfonylureas by limiting all analyses to patients receiving monotherapy with one of these two drug classes. We will examine the association between OAD monotherapy (TZD vs. sulfonylurea) and HbA1c by performing a repeated-measures analysis using linear regression models with a robust sandwich estimator. We will also analyze the association between OAD monotherapy (TZD vs. sulfonylurea) and time to cardiovascular events and death using Cox proportional hazards models. We will further conduct as-treated and intention-to-treat analyses in addition to other sensitivity analyses, and employ advanced statistical methods including propensity score techniques. Racial and ethnic differences in these associations will be investigated using the method described above for the first two aims. Significance: This research study will take advantage of an unusually large and detailed dataset of patients initiating HD. Due to the limited data on the associations among diabetes management and treatment, including glycemic control and OAD therapy, and diabetes complications in HD patients with DM, additional studies are warranted in this high-risk population. Moreover, our study will have the ability to investigat racial and ethnic differences in these associations as we capitalize on the enormous size of the database that will be available for analysis.

描述（由申请人提供）：在血液透析（HD）糖尿病（DM）患者中，患糖尿病相关并发症和死亡率的风险很高。但是，DM患者的糖尿病控制，治疗和与糖尿病有关的并发症之间的关联数据非常有限。此外，尚未记录这些关系中的种族和种族差异。目的：这项观察性研究的目的是评估血糖控制，口服抗糖尿病药物（OAD）治疗以及HD患者HD患者的心血管和非心血管结局之间的关系。我们还将探索这些关联中的种族和种族差异。方法：我们将使用来自美国肾脏数据系统和Davita，Inc。的电子病历的数据，对HD患者进行回顾性队列研究，该研究是在大型国家提供者的糖尿病中使用糖尿病的糖尿病。 透析服务以检查HBA1C和各种临床结果之间的关联（特定目的1和2）。这些患者的一部分将用于接受接受TZD或磺酰脲单一疗法的患者的比较有效性研究（特定AIM 3）。对于前两个目标，我们将使用COX比例危害模型来评估HBA1C与感兴趣的主要结果之间的关联，并通过种族和种族进行效果修改测试 包括交互术语和执行WALD测试。在找到重要的互动术语时，我们将进一步探讨不同种族和种族之间的对比。针对特定 AIM 3，我们将通过将所有分析的所有分析限制在接受这两种药物中的一种的患者中，将TZD的普遍和事件使用者与磺酰鲁里雷斯的使用者进行比较。我们将通过使用线性回归模型进行具有强大的三明治估计量的线性回归模型进行重复测量分析，从而检查OAD单一疗法（TZD与磺酰脲）和HBA1C之间的关联。我们还将使用COX比例危害模型分析OAD单一疗法（TZD与磺酰脲）与心血管事件和死亡的时间之间的关联。除其他敏感性分析外，我们还将进一步进行经过处理和意向性治疗的分析，并采用包括倾向得分技术在内的先进统计方法。这些关联中的种族和种族差异将使用上述前两个目的的上述方法进行研究。意义：这项研究将利用异常大而详细的HD患者数据集。由于有关糖尿病管理与治疗之间关联的数据有限，包括血糖控制和OAD治疗以及HD患有DM的糖尿病并发症，因此在此高风险人群中保证了其他研究。此外，当我们利用可用于分析的数据库的巨大规模时，我们的研究将有能力研究这些关联的种族和种族差异。