Pragmatic Trials

Randomized controlled trials (RCT) evaluate the efficacy of interventions under ideal conditions. However, they present limitations in orthopedic surgery due to recruitment and blinding challenges. Pragmatic trials offer the advantage of enabling interventions to be evaluated in real-world settings. They can evaluate treatment effectiveness by incorporating broader definitions of surgical interventions, using larger patient populations, and providing flexibility with monitoring and follow-up. Pragmatic trials can determine the overall utility of a treatment intervention with high external validity. Most clinical trials fall somewhere along a spectrum between an explanatory RCT and a pragmatic trial. Tools such as the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) can be used to measure the relative pragmatism of any given study. In addition, stepped-wedge trials are a newly emerging study design in which groups or clusters are randomized by time rather than by assignment to the treatment intervention so that all participants receive the intervention by the end of the study. Cluster RCT and stepped-wedge trials require advanced analysis techniques to account for potentially correlated measurements and time-dependent variables, respectively.