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）：患有糖尿病（DM）的血液透析（HD）患者，发生糖尿病相关并发症和死亡率的风险很高。然而，关于 HD 合并 DM 患者的糖尿病控制、治疗和糖尿病相关并发症之间关系的数据极其有限。此外，这些关系中的种族和民族差异尚未得到记录。目的：本观察性研究的目的是评估 HD 合并 DM 患者的血糖控制、口服抗糖尿病药物 (OAD) 治疗以及心血管和非心血管结局之间的关系。我们还将探讨这些协会中的种族和民族差异。方法：我们将使用美国肾脏数据系统的数据和 DaVita, Inc. 的电子病历，对一家大型全国医疗服务提供商的 HD 合并糖尿病患者进行回顾性队列研究。 透析服务以检查 HbA1c 与各种临床结果之间的关联（具体目标 1 和 2）。这些患者的一部分将用于接受 TZD 或磺酰脲类单一疗法的患者的有效性比较研究（具体目标 3）。对于前两个目标，我们将使用 Cox 比例风险模型来评估 HbA1c 与达到主要目标结果的时间之间的关联，并通过种族和民族来测试效应修正 包括交互项并执行 Wald 测试。在找到重要的交互项后，我们将进一步探讨不同种族和族裔群体之间的对比。对于特定的 目标 3，我们将通过将所有分析限制于接受这两种药物类别之一的单一疗法的患者，将 TZD 的流行和偶发使用者与磺酰脲类使用者进行比较。我们将通过使用线性回归模型和稳健的夹心估计器进行重复测量分析，检查 OAD 单一疗法（TZD 与磺酰脲类）和 HbA1c 之间的关联。我们还将使用 Cox 比例风险模型分析 OAD 单一疗法（TZD 与磺脲类药物）与心血管事件和死亡时间之间的关联。除了其他敏感性分析之外，我们还将进一步进行治疗分析和意向治疗分析，并采用包括倾向评分技术在内的先进统计方法。将使用上述前两个目标的方法来调查这些协会中的种族和民族差异。意义：这项研究将利用异常庞大且详细的 HD 患者数据集。由于有关糖尿病管理和治疗（包括血糖控制和 OAD 治疗）与 HD 合并 DM 患者糖尿病并发症之间关系的数据有限，因此有必要在这一高危人群中进行更多研究。此外，我们的研究将有能力调查这些关联中的种族和民族差异，因为我们利用可用于分析的庞大数据库。