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Randomized Controlled Trial
. 2023 May:128:107172.
doi: 10.1016/j.cct.2023.107172. Epub 2023 Mar 31.

Concordance between clinical outcomes in the Systolic Blood Pressure Intervention Trial and in the electronic health record

Chi D Chu  1 , Kristin M Lenoir  2 , Nayanjot Kaur Rai  3 , Sandeep Soman  4 , Jamie P Dwyer  5 , Michael V Rocco  6 , Anil K Agarwal  7 , Srinivasan Beddhu  6 , James R Powell  8 , Maritza M Suarez  9 , James P Lash  10 , Andrew McWilliams  11 , Paul K Whelton  12 , Paul E Drawz  3 , Nicholas M Pajewski  2 , Areef Ishani  3 , Delphine S Tuot  13
Affiliations
Randomized Controlled Trial

Concordance between clinical outcomes in the Systolic Blood Pressure Intervention Trial and in the electronic health record

Chi D Chu et al. Contemp Clin Trials. 2023 May.

Abstract

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.

Keywords: Cardiovascular outcomes; Electronic health record; Outcome ascertainment; Pragmatic trial.

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Conflict of interest statement

Declaration of Competing Interest CDC receives research support from Bayer Healthcare, Inc. outside the submitted work. AM reports ownership interest in iEnroll, LLC. The remaining authors have nothing to disclose.

Figures

Figure 1.
Figure 1.. Study Flow Diagram
Abbreviations: CVD = cardiovascular disease; EHR = electronic health record; ICD = International Classification of Diseases; SBP = systolic blood pressure; SPRINT = Systolic Blood Pressure Intervention Trial.
Figure 2.
Figure 2.. Concordance of Electronic Health Records with Serious Adverse Event Reports for Cardiovascular Events in the Systolic Blood Pressure Intervention Trial
Error bars indicate 95% confidence intervals. Abbreviations: CVD = cardiovascular disease; MI/ACS = myocardial infarction/acute coronary syndrome; NPV = negative predictive value; PPV = positive predictive value.
Figure 3.
Figure 3.. Incidence Rates of Non-CVD Adverse Events Ascertained in SPRINT and EHR Follow Up
Note that denominators differ by adverse event type due to definitions requiring the presence of data in both EHR and trial data (see Supplemental Table 1). Abbreviations: CI = confidence interval; CVD = cardiovascular disease; EHR = electronic health record; SPRINT = Systolic Blood Pressure Intervention Trial.
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