Challenges to randomized trials in adult and congenital cardiac and thoracic surgery.

Overview

Randomized trials in surgery face additional challenges compared to those in medicine. Some of the challenges are intrinsic to the nature of the field (such as issues with blinding, learning curve and surgeons experience and difficulties in defining the appropriate timing for comparative trials). Other issues are due 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 with experience in trials in congenital and adult cardiac and thoracic surgery discusses the key issues with surgical trials and suggest potential solutions.