Surgery and the randomised controlled trial: past, present and future

Med J Aust. 1998 Oct 5;169(7):380-3. doi: 10.5694/j.1326-5377.1998.tb126809.x.


Randomised controlled trials (RCTs), with their prospective definition of methods and outcome measures, double-blind assessment of outcomes and unbiased selection of subjects and controls, provide the best possible evidence for deciding the value of a medical or surgical intervention. Few surgical studies are designed as RCTs, and those that are should be of a higher quality. The lack of good surgical RCTs may be a result of surgeons lacking the necessary training, expertise and desire to perform RCTs, inadequate funding from granting agencies, difficulties in securing patient consent or a lack of sufficient patient numbers. If an RCT is not feasible for a particular study, then alternative research designs, such as prospective matched-pair trials, may need to be better developed and used. If RCTs can be performed, other strategies to increase the number and quality of RCTs may be needed: Education of surgeons in clinical research methods Improved funding of surgical RCTs Compulsory evaluation of new techniques and technology before their general adoption is permitted.

Publication types

  • Review

MeSH terms

  • Evidence-Based Medicine / trends*
  • Forecasting
  • General Surgery / trends*
  • Humans
  • Outcome Assessment, Health Care / trends
  • Randomized Controlled Trials as Topic