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Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom

Accuracy of Healthcare Data in Identifying Cardiovascular Outcomes After Stroke

Background

Healthcare systems data (HCSD) can make clinical trials more efficient, but their accuracy is not always clear. This study aimed to evaluate how accurate HCSD is for detecting outcomes in the RESTART trial, comparing it to follow-up questionnaires.

Methods

RESTART was a clinical trial in the UK that looked at antiplatelet therapy after a type of stroke called intracerebral haemorrhage (ICH). Out of 537 participants, 496 were included in the study. Participants were randomly assigned to either start or avoid antiplatelet therapy. The trial used annual questionnaires to track outcomes over about 2 years, with an independent committee verifying results using medical records. HCSD was used to identify outcomes based on hospital admissions and deaths.

Results

In the trial, 31 participants had a primary outcome event. HCSD showed:

  • Sensitivity: 84% for recurrent ICH
  • Positive Predictive Value: 68% for recurrent ICH

HCSD estimated the effect of antiplatelet therapy similarly to the adjudicated outcomes. For major adverse cardiovascular events (MACE), HCSD had:

  • Sensitivity: 84%
  • Positive Predictive Value: 78%

Again, HCSD provided comparable estimates of treatment effects to the adjudicated outcomes.

Conclusions

HCSD was reasonably accurate in a clinical trial of antiplatelet therapy for ICH and provided similar treatment effect estimates compared to traditional methods.

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