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  5. Randomized Trials in Cardiac Surgery: Why and How

Randomized Trials in Cardiac Surgery: Why and How

File(s)
40347458.pdf (1.46 MB)
No Access Until
2026-06-03
Permanent Link(s)
https://hdl.handle.net/1813/117945
Collections
Department of Cardiothoracic Surgery
Author
Gaudino, M.
Siepe, M.
Murphy, G.J.
Williams, B.
Sandner, S.
Gregg, A.C.
Moskowitz, A.J.
Falk, V.
Gelijns, A.C.
Abstract

OBJECTIVES: Randomised clinical trials (RCTs) are the gold standard for comparative effectiveness. However, they face unique challenges in cardiac surgery. The objective of this work is to summarize the challenges of RCTs in cardiac surgery, describe efforts employed in recent years to mitigate these impediments and outline the future opportunities for increased RCT adoption in the specialty. METHODS: This review was conducted as an expert analysis on the existing state of RCTs in cardiac surgery based on expert discussion at a dedicated session during the 2024 Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS). Different trial-support infrastructures, such as the Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts (ROMA) Network, the Cardiothoracic Trials Surgical Network (CTSN), the Global Cardiovascular Research Funders Forum (GCRFF) and the United Kingdom Model, and their respective mechanisms for overcoming RCT barriers were described in detailed. Models were selected due to specific author involvement and knowledge. Future directions were postulated based on current trends. RESULTS: Despite heterogeneous structures, the described models largely aimed to increased cardiac RCTs through improved trial participation, either via increased trainees, expanded stakeholders or focused patient recruitment, facilitating funding and fostering wider collaboration. CONCLUSIONS: RCTs are a key component for clinical advancement yet have been underutilized in cardiac surgery. Recent endeavors have reduced the multifactorial barriers associated with cardiac surgery RCTs and intentional future efforts are necessary for continued cardiac advancement.

Journal / Series
European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery
Volume & Issue
67(6)
Date Issued
2025-06-03
Publisher
Oxford University Press
Keywords
WCM Library Coordinated Deposit
•
Humans
•
Cardiac Surgical Procedures/methods
•
Randomized Controlled Trials as Topic/methods
•
Cardiac surgery
•
Randomized control trials
Related DOI
https://doi.org/10.1093/ejcts/ezaf164
Previously Published as
Gaudino M, Siepe M, Murphy GJ, Williams B, Sandner S, Gregg AC, Moskowitz AJ, Falk V, Gelijns AC. Randomized Trials in Cardiac Surgery: Why and How. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2025;67(6):. doi: 10.1093/ejcts/ezaf164. PMID: 40347458.
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International
Rights URI
https://creativecommons.org/licenses/by-nc-nd/4.0/
Type
article

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