W Scott Beattie1, Manoj Lalu2, Matthew Bocock2, Simon Feng2, Duminda N Wijeysundera3, Peter Nagele4, Lee A Fleisher5, Andrea Kurz6, Bruce Biccard7, Kate Leslie8, Simon Howell9, Giovani Landoni10, Hilary Grocott11, Andre Lamy12, Toby Richards13, Paul Myles14. 1. Cardiovascular Anesthesia, University Health Network, University of Toronto, Toronto, ON, Canada. Electronic address: scott.beattie@uhn.ca. 2. Department of Anesthesia, University of Ottawa, Ottawa, ON, Canada. 3. Li Ka Shing Knowledge Institute, St Michaels Hospital, University of Toronto, Toronto, ON, Canada. 4. Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL, USA. 5. Department of Anesthesiology and Critical Care, University of Pennsylvania Health System, Philadelphia, PA, USA. 6. Outcomes Research, Cleveland Clinic, Cleveland, OH, USA. 7. Department of Anesthesia and Perioperative Medicine, University of Cape Town, Cape Town, South Africa. 8. Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Vic., Australia. 9. University of Leeds School of Medicine, Leeds, UK. 10. Center for Intensive Care and Anesthesiology, IRCCS San Raffaele Scientific Institute, Milan, Italy. 11. Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada. 12. Department of Surgery, McMaster University, Hamilton, ON, Canada. 13. University of Western Australia, Perth, Australia. 14. Alfred Health and Monash University Department of Anaesthesia and Perioperative Medicine, Melbourne, Vic., Australia.
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.
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.
Authors: Karim Kouz; Alina Bergholz; Oliver Diener; Maximilian Leistenschneider; Christina Thompson; Friederike Pichotka; Constantin Trepte; Edzard Schwedhelm; Thomas Renné; Linda Krause; Julia Y Nicklas; Bernd Saugel Journal: J Clin Monit Comput Date: 2022-02-24 Impact factor: 2.502
Authors: Lisette M Vernooij; Wilton A van Klei; Karel Gm Moons; Toshihiko Takada; Judith van Waes; Johanna Aag Damen Journal: Cochrane Database Syst Rev Date: 2021-12-21