Extending Inferences from a Randomized Trial to Trial-eligible and Treatment-candidate Target Populations: Examples of Generalizability and Transportability.
EpidemiologyMay 4, 2026 (epub)
Jessica C Young, Issa J Dahabreh, Stefan James et al.
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In 30 seconds
This study extends findings from the VALIDATE-SWEDEHEART randomized trial, which compared bivalirudin and heparin during percutaneous coronary intervention, to broader populations. It assessed the trial-eligible and treatment-candidate populations using logistic regression models. The risk difference for bivalirudin versus heparin was -1.1% in the trial-eligible population and -1.0% in the treatment-candidate population.
Key findings
- Risk difference for bivalirudin versus heparin was -1.1% in the trial-eligible population.
- Risk difference for bivalirudin versus heparin was -1.0% in the treatment-candidate population.
- Risk ratios were 0.92 for trial-eligible and 0.93 for treatment-candidate populations.
Why it matters
Understanding how trial results apply to broader populations is crucial for clinicians making treatment decisions. This study highlights the importance of generalizing trial findings to ensure they are relevant to real-world patient groups.