Concordance Between Blood Pressure in the Systolic Blood Pressure Intervention Trial and in Routine Clinical Practice

Concordance Between Blood Pressure in the Systolic Blood Pressure Intervention Trial and in Routine Clinical Practice
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DOI:
10.1001/jamainternmed.2020.5028
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发表时间:
2020-10-12
影响因子:
39
通讯作者:
Pajewski, Nicholas M.
Pajewski, Nicholas M.
中科院分区:
医学1区
文献类型:
--
作者:
Drawz, Paul E.;Agarwal, Anil;Pajewski, Nicholas M.

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重要性由于用于测量血压(BP)的标准化方案在常规临床实践中的应用可能不一致,因此将来自收缩压干预试验(SPRINT)的结果转化为临床实践是值得关注的。目的评估常规临床实践中获得的BP与使用SPRINT方案获得的BP之间的一致性,以及目标试验BP、设置和参与者是否改变一致性。设计和参与者这项观察性预后研究将来自电子健康记录(EHR)的门诊患者生命体征信息与102个Sprint点中49个点的数据联系起来,从2010年11月8日到2015年8月20日,在3074名50岁或以上没有糖尿病或中风病史的成年人中进行。统计分析从2019年5月21日到2020年3月20日进行。结果获得了3074名参与者的参与者水平的EHR数据(2482名男性[80.7%];平均[SD]年龄,68.5[9.1]岁),以及3次或更多的门诊和试验血压测量。在为期6个月的研究访问至研究干预结束期间,强化治疗组的门诊血压记录的平均收缩压(SBP)比试验访问时测得的血压高7.3 mm Hg(95%CI,7.0~7.6 mm Hg);标准治疗组患者的门诊EHR记录的BP与试验SBP的平均差异较小(4.6 mm Hg[95%CI,4.4~4.9 mm Hg])。Bland-Altman分析表明,EHR中记录的门诊患者BP与试验BP之间的一致性很低,两组治疗组的宽一致性间隔从大约-30 mm Hg到45 mm Hg不等。此外,EHR记录的BP和试验BP之间的差异因地点而异。结论常规临床实践中测量的血压和相关门诊患者的BP普遍高于Sprint测量的BP,强化治疗组的平均SBP差异更大。在EHR记录的血压和试验血压之间存在一致的高度异质性,随着时间的推移,参与者之间和参与者内部以及临床地点之间存在显著的差异。这些结果强调了正确的血压测量技术的重要性,以及当常规临床实践中没有适当地测量血压时,无法应用一个共同的校正系数(即大约10毫米汞柱)来近似研究质量的血压估计。
IMPORTANCE There are concerns with translating results from the Systolic Blood Pressure Intervention Trial (SPRINT) into clinical practice because the standardized protocol used to measure blood pressure (BP) may not be consistently applied in routine clinical practice.OBJECTIVES To evaluate the concordance between BPs obtained in routine clinical practice and those obtained using the SPRINT protocol and whether concordance varied by target trial BP.DESIGN, SETTING, AND PARTICIPANTS This observational prognostic study linking outpatient vital sign information from electronic health records (EHRs) with data from 49 of the 102 SPRINT sites was conducted from November 8, 2010, to August 20, 2015, among 3074 adults 50 years or older with hypertension without diabetes or a history of stroke. Statistical analysis was performed from May 21, 2019, to March 20, 2020.MAIN OUTCOMES AND MEASURES Blood pressures measured in routine clinical practice and SPRINT.RESULTS Participant-level EHR data was obtained for 3074 participants (2482 men [80.7%]; mean [SD] age, 68.5 [9.1] years) with 3 or more outpatient and trial BP measurements. In the period from the 6-month study visit to the end of the study intervention, the mean systolic BP (SBP) in the intensive treatment group from outpatient BP recorded in the EHR was 7.3 mm Hg higher (95% CI, 7.0-7.6 mm Hg) than BP measured at trial visits; the mean difference between BP recorded in the outpatient EHR and trial SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]). Bland-Altman analyses demonstrated low agreement between outpatient BP recorded in the EHR and trial BP, with wide agreement intervals ranging from approximately -30 mm Hg to 45 mm Hg in both treatment groups. In addition, the difference between BP recorded in the EHR and trial BP varied widely by site.CONCLUSIONS AND RELEVANCE Outpatient BPs measured in routine clinical practice were generally higher than BP measurements taken in SPRINT, with greater mean SBP differences apparent in the intensive treatment group. There was a consistent high degree of heterogeneity between the BPs recorded in the EHR and trial BPs, with significant variability over time, between and within the participants, and across clinic sites. These results highlight the importance of proper BP measurement technique and an inability to apply 1 common correction factor (ie, approximately 10 mm Hg) to approximate research-quality BP estimates when BP is not measured appropriately in routine clinical practice.