Interpreting Neurologic Outcomes in a Changing Trial Design Landscape: An Analysis of HVAD Using a Hybrid Intention to Treat Population. ASAIO journal (American Society for Artificial Internal Organs : 1992) Mahr, C., Thinh Pham, D., Mokadam, N. A., Silvestry, S. C., Cowger, J., Kiernan, M. S., D'alessandro, D. A., Coglianese, E. E., Faraz Masood, M., Kormos, R. L., Jacoski, M. V., Teuteberg, J. J. 2018

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.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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