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.
Original language | English (US) |
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Article number | 107172 |
Journal | Contemporary Clinical Trials |
Volume | 128 |
DOIs | |
State | Published - 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
Keywords
- Cardiovascular outcomes
- Electronic health record
- Outcome ascertainment
- Pragmatic trial
PubMed: MeSH publication types
- Journal Article
- Randomized Controlled Trial
- Research Support, N.I.H., Extramural