TY - JOUR
T1 - Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative
T2 - cardiovascular outcomes
AU - StEP-COMPAC Group
AU - Beattie, W Scott
AU - Lalu, Manoj
AU - Bocock, Matthew
AU - Feng, Simon
AU - Wijeysundera, Duminda N
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 - Schultz, Marcus J.
N1 - Funding Information: We would like to acknowledge the work of the data extractors who are listed in the appendix. Finally, we would like to thank Sophia Wallace for her tireless work on coordinating the DELPHI rounds, communications, and collation of the results. 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 - MACE
KW - cardiovascular events
KW - clinical trials
KW - myocardial infarction
KW - outcome measures
KW - perioperative medicine
KW - standardised endpoint
UR - http://www.scopus.com/inward/record.url?scp=85092930137&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.bja.2020.09.023
DO - https://doi.org/10.1016/j.bja.2020.09.023
M3 - Review article
C2 - 33092804
SN - 0007-0912
VL - 126
SP - 56
EP - 66
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 1
ER -