Challenges of randomized controlled surgical trials.

The concept of evidence-based medicine has gained broad support in the medical community, because clinical decisions based on information from rigorous scientific study are most likely to provide optimal care. Researchers attempt to answer clinical questions using either observational studies or randomized controlled trials (RCTs). Observational studies currently dominate the surgical literature but provide a level of evidence inferior to RCTs. RCTs are ethically grounded in clinical equipoise and may further reduce the potential for bias or other confounding factors by blinding. This article discusses the barriers to implementation of surgical RCTs. Copyright 2010 Elsevier Inc. All rights reserved.