Challenges to Randomized Trials in Adult and Congenital Cardiac and Thoracic Surgery

Mario Gaudino, Joanna Chikwe, Emilia Bagiella, Stephen Fremes, David R. Jones, Bryan Meyers, Jane W. Newburger, Richard G. Ohye, Peter Sassalos, Dennis Wigle, Antonino Di Franco

Research output: Contribution to journalReview articlepeer-review

7 Scopus citations


Randomized trials in surgery face additional challenges compared with those in medicine. Some of the challenges are intrinsic to the nature of the field (eg, issues with blinding, learning curve and surgeons’ experience, and difficulties in defining the appropriate timing for comparative trials). Other issues are related to the surgical culture, the attitude of surgeons toward randomized trials, and the lack of support by professional and national bodies. In this review, a group of investigators with experience in trials in congenital and adult cardiac and thoracic surgery discusses the key issues with surgical trials and suggests potential solutions.

Original languageEnglish
Pages (from-to)1409-1418
Number of pages10
JournalAnnals of Thoracic Surgery
Issue number5
StatePublished - May 2022


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