title: Surgery and the randomised controlled trial: past, present and future.
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.
authors.affiliation: Department of Surgery, University of Sydney, NSW.
authors.forename: M J
authors.initials: MJ
authors.lastname: Solomon
authors.forename: R S
authors.initials: RS
authors.lastname: McLeod
mesh_terms: D019317:Evidence-Based Medicine / Q000639:trends*; D005544:Forecasting; D013502:General Surgery / Q000639:trends*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000639:trends; D016032:Randomized Controlled Trials as Topic