Randomized trials in cardiac surgery: JACC Review Topic of the Week

Mario Gaudino; A. Pieter Kappetein; Antonino Di Franco; Emilia Bagiella; Deepak L. Bhatt; Andreas Boening; Mary E. Charlson; Marcus Flather; Annetine C. Gelijns; Frederick Grover; Stuart J. Head; Peter Jüni; Andre Lamy; Marissa Miller; Alan Moskowitz; Wilko Reents; A. Laurie Shroyer; David P. Taggart; Derrick Y. Tam; Marco A. Zenati; Stephen E. Fremes

doi:10.1016/j.jacc.2020.01.048

Randomized trials in cardiac surgery: JACC Review Topic of the Week

Mario Gaudino, A. Pieter Kappetein, Antonino Di Franco, Emilia Bagiella, Deepak L. Bhatt, Andreas Boening, Mary E. Charlson, Marcus Flather, Annetine C. Gelijns, Frederick Grover, Stuart J. Head, Peter Jüni, Andre Lamy, Marissa Miller, Alan Moskowitz, Wilko Reents, A. Laurie Shroyer, David P. Taggart, Derrick Y. Tam, Marco A. ZenatiStephen E. Fremes

Research output: Contribution to journal › Review article › peer-review

28 Citations (Scopus)

Abstract

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators’ expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

Original language	English
Pages (from-to)	1593-1604
Number of pages	12
Journal	Journal of the American College of Cardiology
Volume	75
Issue number	13
Early online date	30 Mar 2020
DOIs	https://doi.org/10.1016/j.jacc.2020.01.048
Publication status	Published - 7 Apr 2020

Keywords

cardiac surgery
randomized controlled trials
RCT

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10.1016/j.jacc.2020.01.048

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Gaudino, M., Kappetein, A. P., Di Franco, A., Bagiella, E., Bhatt, D. L., Boening, A., Charlson, M. E., Flather, M., Gelijns, A. C., Grover, F., Head, S. J., Jüni, P., Lamy, A., Miller, M., Moskowitz, A., Reents, W., Shroyer, A. L., Taggart, D. P., Tam, D. Y., ... Fremes, S. E. (2020). Randomized trials in cardiac surgery: JACC Review Topic of the Week. Journal of the American College of Cardiology, 75(13), 1593-1604. https://doi.org/10.1016/j.jacc.2020.01.048

Gaudino, Mario ; Kappetein, A. Pieter ; Di Franco, Antonino ; Bagiella, Emilia ; Bhatt, Deepak L. ; Boening, Andreas ; Charlson, Mary E. ; Flather, Marcus ; Gelijns, Annetine C. ; Grover, Frederick ; Head, Stuart J. ; Jüni, Peter ; Lamy, Andre ; Miller, Marissa ; Moskowitz, Alan ; Reents, Wilko ; Shroyer, A. Laurie ; Taggart, David P. ; Tam, Derrick Y. ; Zenati, Marco A. ; Fremes, Stephen E. / Randomized trials in cardiac surgery : JACC Review Topic of the Week. In: Journal of the American College of Cardiology. 2020 ; Vol. 75, No. 13. pp. 1593-1604.

@article{2a845ed749b84b75a132543cd86311b4,

title = "Randomized trials in cardiac surgery: JACC Review Topic of the Week",

abstract = "Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators{\textquoteright} expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.",

keywords = "cardiac surgery, randomized controlled trials, RCT",

author = "Mario Gaudino and Kappetein, {A. Pieter} and {Di Franco}, Antonino and Emilia Bagiella and Bhatt, {Deepak L.} and Andreas Boening and Charlson, {Mary E.} and Marcus Flather and Gelijns, {Annetine C.} and Frederick Grover and Head, {Stuart J.} and Peter J{\"u}ni and Andre Lamy and Marissa Miller and Alan Moskowitz and Wilko Reents and Shroyer, {A. Laurie} and Taggart, {David P.} and Tam, {Derrick Y.} and Zenati, {Marco A.} and Fremes, {Stephen E.}",

year = "2020",

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doi = "10.1016/j.jacc.2020.01.048",

language = "English",

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Gaudino, M, Kappetein, AP, Di Franco, A, Bagiella, E, Bhatt, DL, Boening, A, Charlson, ME, Flather, M, Gelijns, AC, Grover, F, Head, SJ, Jüni, P, Lamy, A, Miller, M, Moskowitz, A, Reents, W, Shroyer, AL, Taggart, DP, Tam, DY, Zenati, MA & Fremes, SE 2020, 'Randomized trials in cardiac surgery: JACC Review Topic of the Week', Journal of the American College of Cardiology, vol. 75, no. 13, pp. 1593-1604. https://doi.org/10.1016/j.jacc.2020.01.048

Randomized trials in cardiac surgery : JACC Review Topic of the Week. / Gaudino, Mario; Kappetein, A. Pieter; Di Franco, Antonino; Bagiella, Emilia; Bhatt, Deepak L.; Boening, Andreas; Charlson, Mary E.; Flather, Marcus; Gelijns, Annetine C.; Grover, Frederick; Head, Stuart J.; Jüni, Peter; Lamy, Andre; Miller, Marissa; Moskowitz, Alan; Reents, Wilko; Shroyer, A. Laurie; Taggart, David P.; Tam, Derrick Y.; Zenati, Marco A.; Fremes, Stephen E.

In: Journal of the American College of Cardiology, Vol. 75, No. 13, 07.04.2020, p. 1593-1604.

Research output: Contribution to journal › Review article › peer-review

TY - JOUR

T1 - Randomized trials in cardiac surgery

T2 - JACC Review Topic of the Week

AU - Gaudino, Mario

AU - Kappetein, A. Pieter

AU - Di Franco, Antonino

AU - Bagiella, Emilia

AU - Bhatt, Deepak L.

AU - Boening, Andreas

AU - Charlson, Mary E.

AU - Flather, Marcus

AU - Gelijns, Annetine C.

AU - Grover, Frederick

AU - Head, Stuart J.

AU - Jüni, Peter

AU - Lamy, Andre

AU - Miller, Marissa

AU - Moskowitz, Alan

AU - Reents, Wilko

AU - Shroyer, A. Laurie

AU - Taggart, David P.

AU - Tam, Derrick Y.

AU - Zenati, Marco A.

AU - Fremes, Stephen E.

PY - 2020/4/7

Y1 - 2020/4/7

N2 - Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators’ expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

AB - Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators’ expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

KW - cardiac surgery

KW - randomized controlled trials

KW - RCT

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U2 - 10.1016/j.jacc.2020.01.048

DO - 10.1016/j.jacc.2020.01.048

M3 - Review article

C2 - 32241376

AN - SCOPUS:85082028734

VL - 75

SP - 1593

EP - 1604

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 13

ER -

Randomized trials in cardiac surgery: JACC Review Topic of the Week

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