Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement.

JACC. Cardiovascular Interventions
Neel M ButalaRobert W Yeh

Abstract

The aim of this study was to evaluate the performance of administrative claims in ascertaining trial clinical events committee-adjudicated outcomes in the U.S. CoreValve studies. Real-world data offer tremendous opportunity to improve outcome ascertainment in clinical trials. However, little is known about the validity of outcomes ascertained using real-world data to capture trial endpoints. Patients enrolled in 3 pivotal trials and 2 pre-market continued-access studies evaluating transcatheter aortic valve replacement were linked to Medicare fee-for-service inpatient claims. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement statistic of claims to detect clinical endpoints and procedural complications in trial patients were calculated. Claims accurately identified trial-adjudicated deaths (sensitivity, specificity, PPV, and NPV all >99.6%; kappa 1.00). Claims had good performance in identifying trial-adjudicated permanent pacemaker implantation (sensitivity 92.2%, specificity 99.1%, PPV 96.1%, NPV 98.2%, kappa 0.93) and aortic valve reintervention (sensitivity 84.4%, specificity 99.6%, PPV 69.1%, NPV 99.8%, kappa 0.76). Claims had more modest performance in ascer...Continue Reading

References

Feb 1, 1992·American Journal of Public Health·E S FisherD C Hsia
Apr 20, 2005·Medical Care·Elena Birman-DeychBrian F Gage
Jan 10, 2008·Journal of General Internal Medicine·Chunliu ZhanClaudia Steiner
Sep 1, 2009·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Ethan R EllisMatthew R Reynolds
Sep 25, 2012·Journal of the American College of Cardiology·Arnold J GreensponSteven M Kurtz
Sep 3, 2013·The New England Journal of Medicine·Ole FröbertUNKNOWN TASTE Trial
Nov 19, 2013·JAMA : the Journal of the American Medical Association·José Augusto Barreto-FilhoHarlan M Krumholz
Jan 9, 2014·Circulation. Cardiovascular Quality and Outcomes·Mark A HlatkyMarcia L Stefanick
Mar 25, 2014·Journal of the American College of Cardiology·Jeffrey J PopmaUNKNOWN CoreValve United States Clinical Investigators
Apr 1, 2014·The New England Journal of Medicine·David H AdamsUNKNOWN U.S. CoreValve Clinical Investigators
Jul 30, 2014·American Heart Journal·Erik KjøllerUNKNOWN CLARICOR Trial Group
Jun 22, 2016·Circulation·Scott D Solomon, Marc A Pfeffer
Jul 12, 2016·JAMA : the Journal of the American Medical Association·Jeffrey Shuren, Robert M Califf
Mar 18, 2017·The New England Journal of Medicine·Michael J ReardonUNKNOWN SURTAVI Investigators
Sep 7, 2017·The New England Journal of Medicine·Niteesh K Choudhry
Nov 30, 2018·The New England Journal of Medicine·Richard PlattRachel E Sherman
May 16, 2019·Circulation. Cardiovascular Interventions·Angela LowensternSreekanth Vemulapalli
Jul 13, 2019·Circulation. Cardiovascular Interventions·Christoph B OlivierUNKNOWN CHAMPION PHOENIX Investigators *
Nov 14, 2019·The New England Journal of Medicine·Marco V PerezUNKNOWN Apple Heart Study Investigators

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Citations

Mar 9, 2021·Journal of the American Heart Association·Neel M ButalaRobert W Yeh
Jul 20, 2020·JACC. Cardiovascular Interventions·William S Weintraub, Brandon K Bellows
Jul 19, 2021·JACC. Cardiovascular Interventions·Romain DidierUNKNOWN STOP-AS and France-TAVI
Jul 7, 2021·Therapeutic Innovation & Regulatory Science·Eric L EisensteinKevin J Anstrom

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