Challenges in creating a good randomized controlled trial in hand surgery.
The goal of this article is to inform readers of hand surgery literature and, more importantly, investigators about key design issues in randomized trials in hand surgery. Specifically, it describes the application of the Consolidated Standards of Reporting Trials in hand surgery trials and provides tips for reading the hand surgery literature. Unique challenges in the execution of a randomized controlled trial in hand surgery are explained, including the surgical learning curve, randomization, concealment and blinding, loss to follow-up, intention to treat analysis, surgical equipoise, differential care, and treatment effect and its implications for sample size. Additionally, the relevance of incorporating economic analyses into hand surgery trials and the importance of changing the hand surgeons' research culture are addressed.
Thoma
Achilleas
A
Department of Surgery, McMaster University, Hamilton, Ontario, Canada. athoma@mcmaster.ca
D003365:Costs and Cost Analysis; D017408:Guidelines as Topic; D006225:Hand / Q000601:surgery*; D006801:Humans; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards