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

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
MACE cardiovascular events clinical trials myocardial infarction outcome measures perioperative medicine standardised endpoint

Journal

British journal of anaesthesia
ISSN: 1471-6771
Titre abrégé: Br J Anaesth
Pays: England
ID NLM: 0372541

Informations de publication

Date de publication:
01 2021
Historique:
received: 08 06 2020
revised: 05 09 2020
accepted: 09 09 2020
pubmed: 24 10 2020
medline: 29 1 2021
entrez: 23 10 2020
Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1016/j.bja.2020.09.023 PMID: 33092804
pubmed: 33092804
pii: S0007-0912(20)30780-7
doi: 10.1016/j.bja.2020.09.023
pii:
doi:

Types de publication

Journal Article Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

56-66

Subventions

Organisme : Department of Health
ID : 10/104/06
Pays : United Kingdom

Investigateurs

D Jamie Cooper (DJ)
Paul Myles (P)
T J Gan (TJ)
Andrea Kurz (A)
Phil Peyton (P)
Dan Sessler (D)
Martin Tramèr (M)
Alan Cyna (A)
Gildasio S De Oliveira (GS)
Christopher Wu (C)
Mark Jensen (M)
Henrik Kehlet (H)
Mari Botti (M)
Oliver Boney (O)
Guy Haller (G)
Mike Grocott (M)
Tim Cook (T)
Lee Fleisher (L)
Mark Neuman (M)
David Story (D)
Russell Gruen (R)
Sam Bampoe (S)
Lis Evered (L)
David Scott (D)
Brendan Silbert (B)
Diederik van Dijk (D)
Cor Kalkman (C)
Matthew Chan (M)
Hilary Grocott (H)
Guy Haller (G)
Rod Eckenhoff (R)
Lars Rasmussen (L)
Lars Eriksson (L)
Scott Beattie (S)
Duminda Wijeysundera (D)
Lee Fleisher (L)
Giovanni Landoni (G)
Kate Leslie (K)
Bruce Biccard (B)
Simon Howell (S)
Hilary Grocott (H)
Peter Nagele (P)
Toby Richards (T)
Andre Lamy (A)
Manoj Lalu (M)
Richard J Bartlett (RJ)
Robert McMonnies (R)
Jakob V.E. Gerstl (JV)
Mohammad Jay (M)
David Kishlyansky (D)
Matthew Machina (M)
Matthew Bobcock (M)
Simon Feng (S)
Rupert Pearse (R)
Monty Mythen (M)
Jaume Canet (J)
Ann Moller (A)
Tony Gin (T)
Marcus Schultz (M)
Paolo Pelosi (P)
Marcelo Gabreu (M)
Emmanuel Futier (E)
Ben Creagh-Brown (B)
Tom Abbott (T)
Monty Mythen (M)
Cor Kalkman (C)
Andy Klein (A)
Tomas Corcoran (T)
D Jamie Cooper (DJ)
Stefan Dieleman (S)
Elisabeth Diouf (E)
David McIlroy (D)
Rinaldo Bellomo (R)
Andrew Shaw (A)
John Prowle (J)
Keyvan Karkouti (K)
Josh Billings (J)
Duminda Wijeysundera (D)
Andy Klein (A)
Toby Richards (T)
David Mazer (D)
Paul Myles (P)
Mohindas Jayarajah (M)
Keyvan Karkouti (K)
Michael Murphy (M)
Andre Lamy (A)
Justyna Bartoszko (J)
Rob Sneyd (R)
Scott Beattie (S)
Lee Fleisher (L)
Mike Grocott (M)
Dan Sessler (D)
Steve Morris (S)
Ron George (R)
Ramani Moonesinghe (R)
Matthew Chan (M)
Tim Cook (T)
Paul Myles (P)
Mark Shulman (M)
Mark Neuman (M)
Cor Kalkman (C)
Meghan Lane-Fall (M)
Ulrica Nilsson (U)
Nathalie Stevenson (N)
Mike Grocott (M)
Paul Myles (P)
Rupert Pearse (R)
Andrea Kurz (A)
Ramani Moonesinghe (R)
Jamie Dj Cooper (JD)
Wilton van Klei (W)
Luca Cabrini (L)
Tim Miller (T)
Nathan Pace (N)
Sandy Jackson (S)
Donal Buggy (D)
Dan Sessler (D)
Kate Leslie (K)
Tim Short (T)
Andrea Kurz (A)
Bernhard Riedel (B)
Vijay Gottumukkala (V)
Nathan Pace (N)
Bilal Alkhaffaf (B)
Mark Johnson (M)

Informations de copyright

Copyright © 2020 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

Auteurs

W Scott Beattie (WS)

Cardiovascular Anesthesia, University Health Network, University of Toronto, Toronto, ON, Canada. Electronic address: scott.beattie@uhn.ca.

Manoj Lalu (M)

Department of Anesthesia, University of Ottawa, Ottawa, ON, Canada.

Matthew Bocock (M)

Department of Anesthesia, University of Ottawa, Ottawa, ON, Canada.

Simon Feng (S)

Department of Anesthesia, University of Ottawa, Ottawa, ON, Canada.

Duminda N Wijeysundera (DN)

Li Ka Shing Knowledge Institute, St Michaels Hospital, University of Toronto, Toronto, ON, Canada.

Peter Nagele (P)

Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL, USA.

Lee A Fleisher (LA)

Department of Anesthesiology and Critical Care, University of Pennsylvania Health System, Philadelphia, PA, USA.

Andrea Kurz (A)

Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.

Bruce Biccard (B)

Department of Anesthesia and Perioperative Medicine, University of Cape Town, Cape Town, South Africa.

Kate Leslie (K)

Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Vic., Australia.

Simon Howell (S)

University of Leeds School of Medicine, Leeds, UK.

Giovani Landoni (G)

Center for Intensive Care and Anesthesiology, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Hilary Grocott (H)

Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada.

Andre Lamy (A)

Department of Surgery, McMaster University, Hamilton, ON, Canada.

Toby Richards (T)

University of Western Australia, Perth, Australia.

Paul Myles (P)

Alfred Health and Monash University Department of Anaesthesia and Perioperative Medicine, Melbourne, Vic., Australia.

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