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

ABSTRACT:

Objectives

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.

Background

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.

Methods

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

SUBMITTER: Butala NM 

PROVIDER: S-EPMC7444647 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature