Interpreting Neurologic Outcomes in a Changing Trial Design Landscape: An Analysis of HeartWare Left Ventricular Assist Device Using a Hybrid Intention to Treat Population

ASAIO J. 2019 Mar-Apr;65(3):293-296. doi: 10.1097/MAT.0000000000000931.

Abstract

Randomized controlled trials can provide optimal clinical evidence to assess the benefits of new devices, and it is these data that often shape device usage in real-world practice. However, individual clinical trial results sometimes appear discordant for the same device, and alternative devices are sometimes not employed in similar patient populations. To make sound evidence-based decisions, clinicians routinely rely on cross-trial comparisons from different trials of similar but not identical patient populations to assess competing technology when head-to-head randomized comparisons are unavailable.

MeSH terms

  • Clinical Trials as Topic*
  • Heart Failure / therapy*
  • Heart-Assist Devices*
  • Humans
  • Intention to Treat Analysis / methods*
  • Treatment Outcome