title: The role of the randomized controlled trial in plastic surgery.
abstract: This article discusses the role of the randomized controlled trial (RCT) in plastic surgery. There are unique challenges in the execution of an RCT in plastic surgery, including: (1) surgical equipoise, (2) the surgical learning curve, (3) differential care, (4) randomization, (5) concealment, (6) expertise-based design, (7) blinding, (8) intention-to-treat analysis, (9) loss to follow-up, and (10) treatment effect and implications for sample size calculations. The RCTs conducted in plastic surgery to date are generally of poor quality in design and reporting, are fraught with bias, and have small sample sizes, thus this article attempts to help future investigators perform better quality RCTs.
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada. athoma@mcmaster.ca
authors.forename: Achilleas
authors.initials: A
authors.lastname: Thoma
authors.forename: Sheila
authors.initials: S
authors.lastname: Sprague
authors.forename: Claire
authors.initials: C
authors.lastname: Temple
authors.forename: Stuart
authors.initials: S
authors.lastname: Archibald
mesh_terms: D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D013518:Surgery, Plastic