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Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes

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@article{fa6f1173b7f14b0e965faa54e5909507,
title = "Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes",
abstract = "Background: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials. Methods: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined. Conclusions: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.",
keywords = "Cardiovascular Diseases/diagnosis, Clinical Trials as Topic, Consensus, Delphi Technique, Endpoint Determination/methods, Humans, Perioperative Care/methods, Perioperative Medicine/methods, Postoperative Complications/diagnosis, Research Design",
author = "Beattie, {W. Scott} and Manoj Lalu and Matthew Bocock and Simon Feng and Duminda Wijeysundera and Peter Nagele and Fleisher, {Lee A.} and Andrea Kurz and Bruce Biccard and Kate Leslie and Simon Howell and Giovani Landoni and Hilary Grocott and Andre Lamy and Toby Richards and Paul Myles and Gan, {T. J.} and Phil Peyton and Dan Sessler and Martin Tram{\`e}r and Alan Cyna and {De Oliveira}, {Gildasio S.} and Christopher Wu and Mark Jensen and Henrik Kehlet and Mari Botti and Oliver Boney and Guy Haller and Mike Grocott and Tim Cook and Lee Fleisher and Mark Neuman and David Story and Russell Gruen and Sam Bampoe and Lis Evered and David Scott and Brendan Silbert and {van Dijk}, Diederik and Cor Kalkman and Matthew Chan and Rod Eckenhoff and Lars Rasmussen and Lars Eriksson and Scott Beattie and Duminda Wijeysundera and Giovanni Landoni and Bartlett, {Richard J.} and Robert McMonnies and Ann Moller and {StEP COMPAC Group}",
note = "Publisher Copyright: {\textcopyright} 2020 British Journal of Anaesthesia Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = jan,
doi = "10.1016/j.bja.2020.09.023",
language = "English",
volume = "126",
pages = "56--66",
journal = "British Journal of Anaesthesia",
issn = "0007-0912",
publisher = "Oxford University Press",
number = "1",

}

RIS

TY - JOUR

T1 - Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative

T2 - cardiovascular outcomes

AU - Beattie, W. Scott

AU - Lalu, Manoj

AU - Bocock, Matthew

AU - Feng, Simon

AU - Wijeysundera, Duminda

AU - Nagele, Peter

AU - Fleisher, Lee A.

AU - Kurz, Andrea

AU - Biccard, Bruce

AU - Leslie, Kate

AU - Howell, Simon

AU - Landoni, Giovani

AU - Grocott, Hilary

AU - Lamy, Andre

AU - Richards, Toby

AU - Myles, Paul

AU - Gan, T. J.

AU - Peyton, Phil

AU - Sessler, Dan

AU - Tramèr, Martin

AU - Cyna, Alan

AU - De Oliveira, Gildasio S.

AU - Wu, Christopher

AU - Jensen, Mark

AU - Kehlet, Henrik

AU - Botti, Mari

AU - Boney, Oliver

AU - Haller, Guy

AU - Grocott, Mike

AU - Cook, Tim

AU - Fleisher, Lee

AU - Neuman, Mark

AU - Story, David

AU - Gruen, Russell

AU - Bampoe, Sam

AU - Evered, Lis

AU - Scott, David

AU - Silbert, Brendan

AU - van Dijk, Diederik

AU - Kalkman, Cor

AU - Chan, Matthew

AU - Eckenhoff, Rod

AU - Rasmussen, Lars

AU - Eriksson, Lars

AU - Beattie, Scott

AU - Wijeysundera, Duminda

AU - Landoni, Giovanni

AU - Bartlett, Richard J.

AU - McMonnies, Robert

AU - Moller, Ann

AU - StEP COMPAC Group

N1 - Publisher Copyright: © 2020 British Journal of Anaesthesia Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/1

Y1 - 2021/1

N2 - Background: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials. Methods: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined. Conclusions: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.

AB - Background: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials. Methods: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined. Conclusions: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.

KW - Cardiovascular Diseases/diagnosis

KW - Clinical Trials as Topic

KW - Consensus

KW - Delphi Technique

KW - Endpoint Determination/methods

KW - Humans

KW - Perioperative Care/methods

KW - Perioperative Medicine/methods

KW - Postoperative Complications/diagnosis

KW - Research Design

UR - http://www.scopus.com/inward/record.url?scp=85092930137&partnerID=8YFLogxK

U2 - 10.1016/j.bja.2020.09.023

DO - 10.1016/j.bja.2020.09.023

M3 - Review

C2 - 33092804

AN - SCOPUS:85092930137

VL - 126

SP - 56

EP - 66

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 1

ER -

ID: 63846394