Coronary disease & ACSRandomised controlled trial
Validating national registry data for randomized trials: comparison of registry-derived cardiovascular events with and without adjudication in the BETAMI-DANBLOCK trial
- Registry-based randomized clinical trial
- blinded adjudication
- Danish/Norwegian national patient registries
Authors' conclusion
Registry data provided effect estimates of beta-blockers comparable to adjudicated data. However, adjudication substantially reduced the number of cardiovascular endpoint events and event-specific misclassification appeared, particularly during the first months after the index event.
Study context
- Population
- Patients with myocardial infarction (MI) and no heart failurerandomized
- Participants
- 5,574 patients
- Comparison
- beta-blocker vs controls
Primary result
As reported in the abstract
Capture of primary endpoint events registered by self-report and medical records by national registries
National registries captured primary endpoint events registered by self-report and medical records
99.7%
Further findings
| Outcome | HR (95% CI) | |
|---|---|---|
| Primary endpoint (treatment effect) — beta-blocker vs controls · non-adjudicated events | 0.88 (0.78–0.98) | |
| Primary endpoint (treatment effect) — beta-blocker vs controls · adjudicated events | 0.85 (0.75–0.98) | |
| 0.512Hazard ratio (log scale) |
Registry-identified primary endpoint events confirmed by adjudication
- Confirmed by adjudication
- 75%
- Incidence rate, non-adjudicated vs. adjudicated
- 6.23 vs. 4.43/100 person-years
Confirmation rate by event type
- ischaemic stroke
- 92%
- unplanned coronary revascularizations and heart failure
- 45%
- Confirmation rate lower during the first 6 months
Primary endpoint (treatment effect)
- No apparent differences across event types except for heart failure and revascularization
Original publication
Validating national registry data for randomized trials: comparison of registry-derived cardiovascular events with and without adjudication in the BETAMI-DANBLOCK trial. Eur Heart J Qual Care Clin Outcomes. Published 4 April 2026. doi:10.1093/ehjqcco/qcag055
Summarised from the published abstract; every number is checked against it