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

Area of Science:

• Cardiology
• Anesthesiology
• Clinical Trials

Background:

• Adverse cardiovascular events significantly contribute to perioperative morbidity and mortality.
• Heterogeneous definitions of perioperative cardiovascular adverse events hinder consistent research.
• The Standardized Endpoints in Perioperative Medicine initiative seeks to address this variability.

Purpose of the Study:

• To achieve consensus among clinical trialists on standardized cardiovascular outcomes for perioperative research.
• To establish valid and reliable endpoints for future clinical trials evaluating perioperative interventions.

Main Methods:

• Systematic literature review to identify existing perioperative cardiovascular outcomes.
• Three-stage Delphi consensus process involving 55 international clinician researchers.
• Assessment of shortlisted outcomes for validity, reliability, feasibility, and clarity.

Main Results:

• Identified 18 cardiovascular outcomes initially, with high participation rates in Delphi rounds.
• Elicited consensus on nine key cardiovascular outcomes: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation.
• The nine consensus outcomes were rated as valid, reliable, feasible, and clearly defined by experts.

Conclusions:

• The nine consensus cardiovascular outcomes provide a standardized set of endpoints for perioperative clinical trials.
• These standardized endpoints can be confidently utilized to improve the quality and comparability of research on perioperative interventions.
• This consensus is expected to enhance the evaluation of interventions aimed at improving perioperative outcomes.