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Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings from the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study
Jordan B. Strom, Kamil F. Faridi, Neel M. Butala, Yuansong Zhao, Hector Tamez, Linda R. Valsdottir, J. Matthew Brennan, Changyu Shen, Jeffrey J. Popma, Dhruv S. Kazi, and Robert W. Yeh
The study attempted to see whether passively collected data could substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials. By linking together a variety of data sets, including clinical trials and medicare inpatient claims, the researchers concluded that the clinical trial and the claims data produced magnitudinally and directionally consistent results for the primary endpoints, though less so for the secondary endpoints.