Trial DesignsDevelopment and validation of an automated algorithm for end point adjudication for a large U.S. national registry
Section snippets
Methods
This study was funded by the American College of CardiologyNCDR and the National Heart, Lung and Blood Institute grants R56HL142765 and R01HL142765. The authors are solely responsible for the design and conduct of this study; all study analyses, the drafting and editing of the paper and its final contents.
Results
Between January 1, 2016 and June 30, 2019, a total of 219 end points including 92 in-hospital peri-procedural and 127 follow-up end points reported by the 585 sites in the LAAO Registry underwent adjudication using the AAA and CEC methods. With an iterative approach, agreement >80% was achieved for all end points, though agreement varied (Table I).
Concordance between the 2 adjudication methods was >90% for all neurologic end points. Percent agreement for peri-procedural and follow-up (through 2
Discussion
We demonstrated that an AAA can be developed to adjudicate major adverse events in a large-scale national registry with a robust data quality program. Validation against traditional CEC adjudication showed very good concordance with >90% agreement for all neurologic event types and >80% agreement for major vascular and major bleeding complications. Importantly, agreement exceeded the pre-specified 80% agreement threshold, making the AAA driven approach to end point ascertainment sufficient for
Conclusion
In conclusion, we developed a novel AAA which, in the context of a robust data quality program, can accurately adjudicate clinical events in a large, national registry. AAA development enhanced the registry data quality processes. Although AAA development identified some data combinations that require greater scrutiny, CEC adjudication was infrequently needed. An AAA based approach to end point ascertainment has the potential to significantly reduce costs and maintain data quality with
Funding
This study was funded by the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) and the National Heart, Lung and Blood Institute (NHLBI) grants R56HL142765 and R01HL142765.
Disclosures
Dr Curtis reported an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the NCDR and equity interest in Medtronic. Dr Freeman reports salary support from the ACC NCDR and the NHLBI and consulting/advisory board fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Biocynetics/Pacemate and Biosense Webster. Dr Friedman has received: research support from Boston Scientific, Biosense Webster, Merit Medical, and Abbott; consulting
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