Adjudicating Registry Data: Benefits and Pitfalls-The ACTION Experience

Abstract

The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry collects data and adjudicates adverse events on pediatric patients receiving mechanical circulatory support at participating centers. To date, the registry includes over 1500 patients from 48 centers. Data collected has been used for research publications, quality improvement projects, and the regulatory support of several ventricular assist devices. While this dataset is large and adjudicated, the registry has real limitations that may limit the interpretation of findings. A full understanding of potential biases and limitations allows researchers and clinicians to make meaningful conclusions from the patient population. This report reviews the strengths and limitations of the ACTION registry to ensure optimal utility among pediatric patients receiving mechanical circulatory support. It also suggests potential areas for improvement to facilitate best care of this vulnerable population.

Keywords: congenital heart disease; heart failure; registry; ventricular assist device.