Requirements for controlled clinical trials of preoperative cardiovascular risk reduction.
Although controlled clinical trials have had a major impact in many areas of cardiovascular disease management, they have had little influence on preoperative cardiac risk reduction. Over the past 2 years, we have conducted the Reduction of Cardiac Operative Risk (RCOR) Trial, a pilot study designed to determine enrollment and event rates for a definitive trial evaluating a strategy to reduce cardiac risk associated with noncardiac surgery. This experience indicates that a successful, definitive trial will require recognition of the multiple questions to be answered, accurate identification of the study population, a large sample size, cooperation between internists, surgeons, and anesthesiologists, and strategies to minimize cost. The high costs and difficulties of such a trial are likely to be outweighed by the enormous benefit of identifying the proper strategy for the use of the expensive testing methods that are currently employed.
Cohen
M C
MC
Cardiovascular Division, Deaconess Hospital, Boston, Massachusetts 02215, USA.
McKenna
C
C
Lewis
S M
SM
Muller
J E
JE
D002318:Cardiovascular Diseases / Q000517:prevention & control*; D018849:Controlled Clinical Trials as Topic / Q000592:standards*; D017048:Health Care Costs; D006801:Humans; D010865:Pilot Projects; D012107:Research Design / Q000592:standards*; D018570:Risk Assessment