Methodological Standards for the Design, Implementation, and Analysis of Randomized Trials in Cardiac Surgery

Published: December 06, 2021

Cardiac Surgeons and Nurses in the Operation Room for a heart valve replacement surgery, operating room, Reykjavik, Iceland.
  • The statement reviews key concepts in randomized trial design and implementation, and the planning, conducting and interpreting of cardiac surgery trials.
  • Randomized controlled trials (RCTs) are considered the highest quality source of evidence for health care decisions; cardiac surgery presents specific methodological challenges in the design, implementation, and analysis of RCTs.
  • Cardiac surgery RCTs tend to have patient cohorts with an under-representation of women and underserved groups. Diversity in trial leadership, and involvement of patient representatives and care stakeholders are key in addressing healthcare disparities in trial design and conduct.