Interpreting Neurologic Outcomes in a Changing Trial Design Landscape: An Analysis of HeartWare Left Ventricular Assist Device Using a Hybrid Intention to Treat Population.
Mahr C, Thinh Pham D, Mokadam NA, Silvestry SC, Cowger J, Kiernan MS, D'Alessandro D A, Coglianese EE, Faraz Masood M, Kormos RL, Jacoski MV, Teuteberg JJ. Interpreting neurologic outcomes in a changing trial design landscape: An analysis of HVAD using a hybrid intention to treat population. Asaio j. 65(3):293-296.
ASAIO journal (American Society for Artificial Internal Organs : 1992)
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.