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

One must attend in medical practice not primarily to plausible theories, but to experience combined with reason, according to Hippocrates.

Abstract

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.