Patient's preference and randomization: new paradigm of evidence-based clinical research.

The limitations associated with the traditional randomized controlled design as applied to clinical surgical research must be recognized. The aim of randomization is to ensure initial comparability between groups of eligible patients for whom treatments are compared, thus eliminating their individual influence on outcome. Randomized controlled trials in the surgical literature are sparse; patient preferences might be a major obstacle to their performance. External validity of results of clinical trials depends on the representativity of patients who participate in trials: Compliance to participate through informed consent may act as a selection bias. In surgical randomized trials where it is not often possible for patients to remain blinded to the treatment to which they have been allocated, patient preferences can influence the effectiveness of treatments. In this setting, we need to look at alternatives and the potential advantages of adopting more flexible and clinically relevant approaches to the design of surgical trials. We have to accept the weight of the patient's individual decision in everyday practice. Hence, to negate the importance of these individual choices when evaluating surgical outcomes is unrealistic. An original design reported herein might become a new paradigm for surgical evaluation.