Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week.
Gaudino M., Kappetein AP., Di Franco A., Bagiella E., Bhatt DL., Boening A., Charlson ME., Flather M., Gelijns AC., Grover F., Head SJ., Jüni P., Lamy A., Miller M., Moskowitz A., Reents W., Shroyer AL., Taggart DP., Tam DY., Zenati MA., Fremes SE.
Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.