Paul E Drawz1, Anil Agarwal2, Jamie P Dwyer3, Edward Horwitz4, James Lash5, Kristin Lenoir6, Andrew McWilliams7, Suzanne Oparil8, Frederic Rahbari-Oskoui9, Mahboob Rahman10, Mark A Parkulo11, Priscilla Pemu12, Dominic S Raj13, Michael Rocco14, Sandeep Soman15, George Thomas16, Delphine S Tuot17, Paul K Whelton18, Nicholas M Pajewski6. 1. Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis. 2. Division of Nephrology, The Ohio State University Wexner Medical Center, Columbus. 3. Division of Nephrology/Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee. 4. Division of Nephrology and Hypertension, MetroHealth Medical Center, Case Western Reserve University. Cleveland, Ohio. 5. Division of Nephrology, Department of Medicine, University of Illinois, Chicago. 6. Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina. 7. Department of Internal Medicine, Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, North Carolina. 8. Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham. 9. Division of Renal Medicine, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. 10. Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio. 11. Division of Community Internal Medicine and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Jacksonville, Florida. 12. Department of Medicine, Morehouse School of Medicine, Atlanta, Georgia. 13. Division of Kidney Diseases and Hypertension, George Washington University, Washington, DC. 14. Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina. 15. Division of Nephrology and Hypertension, Henry Ford Health System, Detroit, Michigan. 16. Department of Nephrology and Hypertension, Cleveland Clinic, Cleveland, Ohio. 17. Division of Nephrology, University of California, San Francisco. 18. Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.
Abstract
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.
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.
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