Blood Pressure and Kidney Function - SPRINT vs Electronic Health Record Data

血压和肾功能 - SPRINT 与电子健康记录数据

• 批准号: 10229386
• 负责人: Paul Englund Drawz
• 金额: $ 69.38万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-17 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10229386
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Address; Adult; American Heart Association; Benefits and Risks; Blood Pressure; Bradycardia; Cardiovascular Diseases; Cardiovascular system; Chronic Disease; Clinic; Clinical Trials; Code; Creatinine; Data; Data Sources; Electronic Health Record; End stage renal failure; Event; Future; Goals; Gold; Guidelines; Heart failure; Hypernatremia; Hypertension; Hypotension; ICD-9; Impairment; Incidence; Individual; Inpatients; Intervention Trial; Kidney; Knowledge; Link; Longitudinal prospective study; Measurement; Measures; Outcome; Outpatients; Participant; Patients; Phase; Physicians; Pragmatic clinical trial; Protocols documentation; Provider; Recommendation; Renal function; Reporting; Research; Risk; Risk Factors; Site; Stroke; Techniques; Translations; Visit; adjudicate; adjudication; adverse event risk; adverse outcome; base; blood pressure intervention; clinical practice; design; follow-up; hyperkalemia; mortality; pragmatic trial; screening

Project Summary/Abstract Hypertension is prevalent in 68.5 million U.S. adults and is one of the leading chronic disease risk factors in the world. The Systolic Blood Pressure Intervention Trial (SPRINT) evaluated the effect of intensive (<120 mmHg) and standard (<140 mmHg) BP targets on cardiovascular events and all-cause mortality. Intensive BP lowering was associated with a 25% reduction in cardiovascular events and a 27% reduction in all-cause mortality. BP measurement in SPRINT followed guideline adherent protocols. Unfortunately, BP measurement in routine clinical practice is often not adherent to American Heart Association recommendations; inappropriate technique is associated with an overestimation of BP by approximately 5 to 15 mmHg. Therefore, the achieved BP in routine clinical practice during the treat to target phase of SPRINT is unknown. An additional limitation of SPRINT is that acute kidney injury (AKI) was only assessed in the inpatient setting and adjudication was based on billing codes and discharge summaries, not the gold standard for assessing AKI – creatinine values. Fortunately, SPRINT was one of the first large trials performed in the era of electronic health records (EHRs). The timing of the SPRINT trial provides a unique opportunity to link SPRINT data to EHR data to perform analyses that would be otherwise infeasible within either data source alone. The goals of the proposed study are to a) inform implementation of the SPRINT results by comparing contemporaneous BP in the routine clinic setting to those measured at SPRINT study visits, b) provide creatinine values to assess the effect of intensive and standard BP targets on rates of AKI and other renal outcomes during the trial and in long-term, post-trial follow-up, and c) inform the design of future pragmatic clinical trials by reporting on the concordance between EHR based and formal SPRINT based assessment of renal and cardiovascular outcomes. For the proposed study, SPRINT and EHR data (BP and creatinine values and ICD-9/10 codes) from a number of the larger SPRINT sites will be linked. The specific aims are to evaluate 1) the concordance between BP measured in the general clinic setting to BP measured using guideline recommended technique at SPRINT research visits; 2) the effect of intensive versus standard BP targets on renal and cardiovascular outcomes using SPRINT and EHR based creatinine values; and 3) the concordance between EHR based and formal SPRINT based assessment of renal and cardiovascular outcomes to inform the design of future pragmatic clinical trials. Our results will support physicians and clinic managers in their efforts to implement appropriate BP measurement protocols and will inform implementation of the SPRINT results. Finally, this study will be the first to link clinical trial data with EHR data on a large scale and will serve as an example for how these types of data can be merged to leverage the strengths of both data sources.

项目概要/摘要 高血压在 6850 万美国成年人中普遍存在，是美国主要的慢性病危险因素之一 世界。收缩压干预试验 (SPRINT) 评估了强化（<120 mmHg）的效果 以及心血管事件和全因死亡率的标准血压目标（<140 mmHg）。强化降压 心血管事件减少 25%，全因死亡率减少 27%。血压 SPRINT 中的测量遵循遵循指南的协议。不幸的是，日常血压测量 临床实践往往不遵守美国心脏协会的建议；不当 该技术会导致血压高估约 5 至 15 mmHg。因此，所取得的 SPRINT 目标治疗阶段常规临床实践中的血压尚不清楚。额外的限制 SPRINT 是指急性肾损伤 (AKI) 仅在住院患者环境中进行评估，并基于 账单代码和出院摘要，而不是评估 AKI（肌酐值）的黄金标准。 幸运的是，SPRINT 是电子健康记录 (EHR) 时代首批进行的大型试验之一。 SPRINT 试验的时机提供了将 SPRINT 数据链接到 EHR 数据以执行的独特机会 单独使用任一数据源进行的分析是不可行的。拟议研究的目标 a) 通过比较常规诊所的同期血压来通知 SPRINT 结果的实施 设置为 SPRINT 研究访视时测量的值，b) 提供肌酐值以评估强化训练的效果 试验期间和试验后长期的 AKI 发生率和标准血压目标 后续行动，以及c）通过报告之间的一致性来为未来的实用临床试验的设计提供信息 基于 EHR 和正式 SPRINT 的肾脏和心血管结局评估。对于提议的 研究、SPRINT 和 EHR 数据（血压和肌酐值以及 ICD-9/10 代码）来自许多较大的 SPRINT 站点将被链接。具体目标是评估 1) 测量的血压之间的一致性 在 SPRINT 研究访问中使用指南推荐的技术测量血压的一般临床环境； 2） 使用 SPRINT 和标准血压目标对肾脏和心血管结局的影响 基于 EHR 的肌酐值； 3) 基于 EHR 和基于正式 SPRINT 之间的一致性 评估肾脏和心血管结局，为未来实用临床试验的设计提供信息。我们的 结果将支持医生和诊所管理者努力实施适当的血压测量 协议并将通知 SPRINT 结果的实施。最后，这项研究将是第一个将临床 大规模的 EHR 数据的试验数据，并将作为如何处理这些类型的数据的示例 合并以利用两个数据源的优势。