Requirements for controlled clinical trials of preoperative cardiovascular risk reduction.

M C Cohen, C McKenna, S M Lewis, J E Muller
Author Information
  1. M C Cohen: Cardiovascular Division, Deaconess Hospital, Boston, Massachusetts 02215, USA.

Abstract

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.

Grants

  1. 1-F32-HL08912-01-PSF/NHLBI NIH HHS

MeSH Term

Cardiovascular Diseases
Controlled Clinical Trials as Topic
Health Care Costs
Humans
Pilot Projects
Research Design
Risk Assessment

Word Cloud

Created with Highcharts 10.0.0risktrialcontrolledclinicaltrialscardiovascularpreoperativecardiacreductionstudydefinitivestrategyAlthoughmajorimpactmanyareasdiseasemanagementlittleinfluencepast2yearsconductedReductionCardiacOperativeRiskRCORTrialpilotdesigneddetermineenrollmenteventratesevaluatingreduceassociatednoncardiacsurgeryexperienceindicatessuccessfulwillrequirerecognitionmultiplequestionsansweredaccurateidentificationpopulationlargesamplesizecooperationinternistssurgeonsanesthesiologistsstrategiesminimizecosthighcostsdifficultieslikelyoutweighedenormousbenefitidentifyingproperuseexpensivetestingmethodscurrentlyemployedRequirements

Similar Articles

Cited By