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. Trial Registration: SPRINT ClinicalTrials.gov Identifier: NCT01206062.
Bibliographical noteFunding Information:
reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study. Dr Agarwal reported receiving grants from Sprint EHR study during the conduct of the study. Dr Dwyer reported receiving grants from the NIH/ National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) during the conduct of the study; receiving personal fees from AstraZeneca and Sanofi; and serving as a consultant to AstraZeneca, Bayer, Sanofi, and CSL Behring outside the submitted work. Dr Horwitz reported receiving grants from the NIH/NIDDK/National Heart, Lung and Blood Institute (NHLBI) during the conduct of the study. Dr Lash reported receiving grants from the NIH during the conduct of the study. Dr McWilliams reported receiving grants from the NIH during the conduct of the study; receiving grants from Heineman Foundation outside the submitted work; and being a cofounder of iEnroll LLC. Dr Oparil reported receiving grants and nonfinancial support from the NIH/NHLBI during the conduct of the study; receiving personal fees from Preventric Diagnostics Inc and CinCor Pharma Inc outside the submitted work; serving as Editor-in-Chief, Current Hypertension Reports (term until 12/2020; Publisher, Springer Science Business Media LLC); and receiving an annual stipend of $5000 from Springer. Dr Rahbari-Oskoui reported receiving grants from the NIH during the conduct of the study; receiving grants and personal fees from Otsuka, Kadmon, and Sanofi; and receiving grants from Reata outside the submitted work. Dr Rahman reported receiving grants from the NIH during the conduct of the study; receiving grants from Bayer and Duke Clinical Research Institute; and receiving personal fees from Relypsa and Reata outside the submitted work. Dr Parkulo reported receiving grants from the NIH during the conduct of the study. Dr Rocco reported receiving grants from the NIH during the conduct of the study; receiving grants from Bayer, Boehringer Ingelheim, and GSK; and receiving personal fees from AbbVie, George Clinical, Beacon Bioscience, and Baxter outside the submitted work. Dr Soman reported receiving grant R01 HL136679 03 from the NHLBI during the conduct of the study. Dr Pajewski reported receiving grants from the NHLBI during the conduct of the study. No other disclosures were reported.
was supported by grants R01HL136679 and R01AG055606 from the National Institutes of Health, and funding from the Alzheimer’s Association. The Systolic Blood Pressure Intervention Trial was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke) under contracts HHSN268200900040C, HHSN268200900046C, HHSN268200900047C, HHSN268200900048C, and HHSN268200900049C and interagency agreement A-HL-13-002-001. It was also supported in part with resources and use of facilities through the Department of Veterans Affairs. Azilsartan and chlorthalidone (combined with azilsartan) were provided by Takeda Pharmaceuticals International Inc. Additional support was provided through the following National Center for Advancing Translational Sciences clinical and translational science awards: UL1TR000439 (awarded to Case Western Reserve University); UL1RR025755 (Ohio State University); UL1RR024134 and UL1TR000003 (University of Pennsylvania); UL1RR025771 (Boston University); UL1TR000093 (Stanford University); UL1RR025752, UL1TR000073, and UL1TR001064 (Tufts University); UL1TR000050 (University of Illinois); UL1TR000005 (University of Pittsburgh); U54TR000017-06 (University of Texas Southwestern Medical Center); UL1TR000105-05 (University of Utah); UL1 TR000445 (Vanderbilt University); UL1TR000075 (George Washington University); UL1 TR000002 (University of California, Davis); UL1 TR000064 (University of Florida); and UL1TR000433 (University of Michigan); and by National Institute of General Medical Sciences, Centers of Biomedical Research Excellence award NIGMS P30GM103337 (awarded to Tulane University).
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PubMed: MeSH publication types
- Clinical Trial
- Journal Article
- Observational Study
- Research Support, N.I.H., Extramural
- Research Support, Non-U.S. Gov't
- Research Support, U.S. Gov't, Non-P.H.S.