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: 9398771
• 负责人: Paul Englund Drawz
• 金额: $ 93.45万
• 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 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9398771
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Address; Adult; Adverse event; 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 outcome; base; 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.

项目总结/摘要 高血压在6850万美国成年人中普遍存在，是美国主要的慢性疾病风险因素之一。 世界收缩压干预试验（SPRINT）评估了强化（<120 mmHg） 和标准（<140 mmHg）BP目标对心血管事件和全因死亡率的影响。强化降压 与心血管事件减少25%和全因死亡率减少27%相关。BP SPRINT中的测量遵循遵循指南的方案。不幸的是，常规血压测量 临床实践往往不遵守美国心脏协会的建议;不适当的 该技术与BP高估约5至15 mmHg相关。因此，实现 SPRINT治疗至目标阶段的常规临床实践中的BP未知。一个额外的限制 SPRINT是仅在住院患者中评估急性肾损伤（阿基）， 账单代码和出院摘要，而不是评估阿基-肌酐值的金标准。 幸运的是，SPRINT是电子健康记录（EHR）时代进行的首批大型试验之一。 SPRINT试验的时机提供了一个独特的机会，将SPRINT数据与EHR数据联系起来， 分析，否则将是不可行的，在任何一个数据源单独。拟议研究的目标 a）通过比较常规诊所中的同期血压，告知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治疗的效果 和标准BP目标对试验期间和长期试验后阿基发生率和其他肾脏结局的影响 随访，以及c）通过报告以下内容之间的一致性，为未来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。拟议 研究，SPRINT和EHR数据（BP和肌酐值和ICD-9/10代码）来自一些较大的 SPRINT网站将被链接。具体目的是评价：1） 在SPRINT研究访视时使用指南推荐的技术测量的BP的一般诊所设置; 2） 使用SPRINT评估强化与标准BP目标对肾脏和心血管结局的影响， 基于EHR的肌酐值;以及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，为未来实用的临床试验设计提供信息。我们 结果将支持医生和诊所管理人员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 大规模使用EHR数据的试验数据，并将作为这些类型的数据如何 合并以利用两个数据源的优势。