Concordance between clinical outcomes in the systolic blood pressure intervention trial and in the electronic health record

Chi D. Chu, Kristin M. Lenoir, Nayanjot Kaur Rai, Sandeep Soman, Jamie P. Dwyer, Michael V. Rocco, Anil K. Agarwal, Srinivasan Beddhu, James R. Powell, Maritza M. Suarez, James P. Lash, Andrew McWilliams, Paul K. Whelton, Paul E. Drawz, Nicholas M. Pajewski, Areef Ishani, Delphine S. Tuot

Research output: Contribution to journalArticlepeer-review


Background: Randomized trials are the gold standard for generating clinical practice evidence, but follow-up and outcome ascertainment are resource-intensive. Electronic health record (EHR) data from routine care can be a cost-effective means of follow-up, but concordance with trial-ascertained outcomes is less well-studied. Methods: We linked EHR and trial data for participants of the Systolic Blood Pressure Intervention Trial (SPRINT), a randomized trial comparing intensive and standard blood pressure targets. Among participants with available EHR data concurrent to trial-ascertained outcomes, we calculated sensitivity, specificity, positive predictive value, and negative predictive value for EHR-recorded cardiovascular disease (CVD) events, using the gold standard of SPRINT-adjudicated outcomes (myocardial infarction (MI)/acute coronary syndrome (ACS), heart failure, stroke, and composite CVD events). We additionally compared the incidence of non-CVD adverse events (hyponatremia, hypernatremia, hypokalemia, hyperkalemia, bradycardia, and hypotension) in trial versus EHR data. Results: 2468 SPRINT participants were included (mean age 68 (SD 9) years; 26% female). EHR data demonstrated ≥80% sensitivity and specificity, and ≥ 99% negative predictive value for MI/ACS, heart failure, stroke, and composite CVD events. Positive predictive value ranged from 26% (95% CI; 16%, 38%) for heart failure to 52% (95% CI; 37%, 67%) for MI/ACS. EHR data uniformly identified more non-CVD adverse events and higher incidence rates compared with trial ascertainment. Conclusions: These results support a role for EHR data collection in clinical trials, particularly for capturing laboratory-based adverse events. EHR data may be an efficient source for CVD outcome ascertainment, though there is clear benefit from adjudication to avoid false positives.

Original languageEnglish (US)
Article number107172
JournalContemporary Clinical Trials
StatePublished - May 2023

Bibliographical note

Funding Information:
Research reported in this publication was supported by the Agency for Healthcare Research and Quality under award number K12HS026383 , the National Center for Advancing Translational Sciences of the NIH under award number KL2TR001870 , and the National Heart Lung and Blood Institute under award number R01HL136679 . The content is solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Publisher Copyright:
© 2023 The Authors


  • Cardiovascular outcomes
  • Electronic health record
  • Outcome ascertainment
  • Pragmatic trial

PubMed: MeSH publication types

  • Journal Article
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural


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