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

doi:10.1016/j.athoracsur.2020.11.042

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 journal › Review article › peer-review

9 Scopus citations

Abstract

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 language	English
Pages (from-to)	1409-1418
Number of pages	10
Journal	Annals of Thoracic Surgery
Volume	113
Issue number	5
DOIs	https://doi.org/10.1016/j.athoracsur.2020.11.042
State	Published - May 2022

Access to Document

10.1016/j.athoracsur.2020.11.042

Cite this

@article{22b46391b678401b999dc095155ab23b,

title = "Challenges to Randomized Trials in Adult and Congenital Cardiac and Thoracic Surgery",

abstract = "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{\textquoteright} 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.",

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

note = "Publisher Copyright: {\textcopyright} 2022 The Society of Thoracic Surgeons",

year = "2022",

month = may,

doi = "10.1016/j.athoracsur.2020.11.042",

language = "English",

volume = "113",

pages = "1409--1418",

journal = "Annals of Thoracic Surgery",

issn = "0003-4975",

number = "5",

}

TY - JOUR

T1 - Challenges to Randomized Trials in Adult and Congenital Cardiac and Thoracic Surgery

AU - Gaudino, Mario

AU - Chikwe, Joanna

AU - Bagiella, Emilia

AU - Fremes, Stephen

AU - Jones, David R.

AU - Meyers, Bryan

AU - Newburger, Jane W.

AU - Ohye, Richard G.

AU - Sassalos, Peter

AU - Wigle, Dennis

AU - Di Franco, Antonino

PY - 2022/5

Y1 - 2022/5

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85116108648&partnerID=8YFLogxK

U2 - 10.1016/j.athoracsur.2020.11.042

DO - 10.1016/j.athoracsur.2020.11.042

M3 - Review article

C2 - 33412133

AN - SCOPUS:85116108648

SN - 0003-4975

VL - 113

SP - 1409

EP - 1418

JO - Annals of Thoracic Surgery

JF - Annals of Thoracic Surgery

IS - 5

ER -

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

Abstract

Access to Document

Other files and links

Fingerprint

Cite this