[Problem-based evidence: non-conventional methods of clinical investigations in surgery]

In the era of evidence-based medicine the application of randomised controlled trials (RCT) are crucial for innovations. In contrast with pharmacological studies surgical innovations have several difficulties: setting up a control group is not always simple, placebo is not easy to define and ethico-legal regulation of sham-operations is not well established yet. Risks of the learning curve, which are variable in time and space are quite characteristic for surgical innovations. There is a need therefore to develop new methodologies to overcome these difficulties and resulting in a widely acceptable outcome. The method of problem-based evidence (PBE) obtains the evidences from particular problems of health care using knowledge and experience; and hereby providing advantage for surgical innovations compared to RCT's. PBE provides more opportunity for organizing surgical research and their international acceptance.