Validating national registry data for randomized trials: comparison of registry-derived cardiovascular events with and without adjudication in the BETAMI-DANBLOCK trial.
Therese Lucia Friis Holmager, Anna Meta Dyrvig Kristensen, Morten Wang Fagerland et al.
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In 30 seconds
The BETAMI-DANBLOCK trial, a randomized controlled trial involving 5574 patients with myocardial infarction, compared registry-derived cardiovascular events with and without adjudication. The study found that 75% of primary endpoint events were confirmed by adjudication, with an incidence rate of 6.23 vs. 4.43/100 person-years. Treatment effects for beta-blockers were consistent across both event identification methods.
Key findings
- 75% of primary endpoint events identified through registries were confirmed by adjudication.
- Incidence rates were 6.23 vs. 4.43 per 100 person-years for adjudicated vs. non-adjudicated events.
- Estimated treatment effects for beta-blockers were HR 0.88 for non-adjudicated and HR 0.85 for adjudicated events.
- Event-specific misclassification was particularly evident in the first 6 months post-index event.
Why it matters
Understanding the accuracy of registry data in clinical trials is crucial for interpreting treatment effects. This study highlights the importance of adjudication in reducing misclassification and ensuring reliable outcomes in cardiovascular research.