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

被引:81
作者
Beattie, W. Scott [1 ]
Lalu, Manoj [2 ]
Bocock, Matthew [2 ]
Feng, Simon [2 ]
Wijeysundera, Duminda N. [3 ]
Nagele, Peter [4 ]
Fleisher, Lee A. [5 ]
Kurz, Andrea [6 ]
Biccard, Bruce [7 ]
Leslie, Kate [8 ]
Howell, Simon [9 ]
Landoni, Giovani [10 ]
Grocott, Hilary [11 ]
Lamy, Andre [12 ]
Richards, Toby [13 ]
Myles, Paul [14 ,15 ]
机构
[1] Univ Hlth Network, Univ Toronto, Cardiovasc Anesthesia, Toronto, ON, Canada
[2] Univ Ottawa, Dept Anesthesia, Ottawa, ON, Canada
[3] Univ Toronto, Li Ka Shing Knowledge Inst, St Michaels Hosp, Toronto, ON, Canada
[4] Univ Chicago, Dept Anesthesia & Crit Care, Box 428, Chicago, IL 60637 USA
[5] Univ Penn Hlth Syst, Dept Anesthesiol & Crit Care, Philadelphia, PA USA
[6] Cleveland Clin, Outcomes Res, Cleveland, OH 44106 USA
[7] Univ Cape Town, Dept Anesthesia & Perioperat Med, Cape Town, South Africa
[8] Royal Melbourne Hosp, Dept Anaesthesia & Pain Management, Melbourne, Vic, Australia
[9] Univ Leeds, Sch Med, Leeds, W Yorkshire, England
[10] IRCCS, Ctr Intens Care & Anesthesiol, San Raffaele Sci Inst, Milan, Italy
[11] Univ Manitoba, Dept Anesthesia & Perioperat Med, Winnipeg, MB, Canada
[12] McMaster Univ, Dept Surg, Hamilton, ON, Canada
[13] Univ Western Australia, Perth, WA, Australia
[14] Alfred Hlth, Melbourne, Vic, Australia
[15] Monash Univ, Dept Anaesthesia & Perioperat Med, Melbourne, Vic, Australia
关键词
cardiovascular events; clinical trials; MACE; myocardial infarction; outcome measures; perioperative medicine; standardised endpoint; NONCARDIAC SURGERY; MYOCARDIAL INJURY; 30-DAY MORTALITY; TROPONIN LEVELS; CARDIAC RISK; ASSOCIATION; GUIDELINES; MANAGEMENT; SOCIETY;
D O I
10.1016/j.bja.2020.09.023
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
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.
引用
收藏
页码:56 / 66
页数:11
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