title: Studying surgical innovations: challenges of the randomized controlled trial.
abstract: The randomized controlled trial (RCT) is designed to measure the efficacy of an intervention and is considered to be the most rigorous form of research, allowing for causal inferences to be made between treatments and outcomes. When designing an RCT, one must consider its essential methodological components including randomization, allocation, blinding, choice of outcome measures, sample size, loss to follow-up, and crossover. In contrast to RCTs of medical therapy, surgical trials face unique challenges that can affect study design, implementation, and interpretation of results. However, there are strategies that researchers can use to try to mitigate many of these challenges to improve the validity of the study. In addition, there are unique ethical considerations that must be examined when designing surgical trials, and steps must be taken to acknowledge them while maintaining the integrity of the study design. RCTs remain the best design to evaluate the efficacy of novel surgical treatments; however, researchers should be aware of and address the unique challenges inherent to surgical trials.
authors.affiliation: Obstetrics, Gynecology, and Women's Health Institute, Center for Urogynecology and Pelvic Reconstructive Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address: ungerc@ccf.org.
authors.forename: Cecile A
authors.initials: CA
authors.lastname: Unger
authors.affiliation: Obstetrics, Gynecology, and Women's Health Institute, Center for Urogynecology and Pelvic Reconstructive Surgery, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Barber
mesh_terms: D004059:Diffusion of Innovation; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013514:Surgical Procedures, Operative
keywords: Randomized controlled trial; Research; Study design; Surgical trial