Randomized controlled trials for evaluating surgical questions.

OBJECTIVE To discuss some of the obstacles inherent in the design of the randomized controlled trial (RCT) that the surgeon must confront and options to minimize these obstacles. DATA SOURCES The literature was searched for articles discussing RCTs using MEDLINE from 1966 to 1998. STUDY SELECTION Studies relevant to the general use of RCTs for evaluating surgical questions were selected. SYNTHESIS Several problems inherent in RCTs were noted: (1) ethical considerations, (2) difficulties in patient accrual, (3) patient preferences, and (4) variability in surgical proficiency/technique. Some means of minimizing these problems are (1) the concept of clinical equipoise, (2) multicenter trials, and (3) stratified sampling of patients. Alternatives to the classic RCT are discussed, namely, the randomized consent design and the patient preference design. CONCLUSIONS The nature of the RCTs is that they are difficult to use to evaluate surgical techniques. Some options are available to minimize these difficulties. Designing and conducting RCTs to evaluate surgical interventions require careful planning and some compromises. Unless the previously mentioned criteria are applied, the validity of the RCT can be considered no greater than that of other trials.