Pragmatic Clinical Trials in Plastic Surgery.

Abstract

The use of pragmatic clinical trials (PCTs) has been increasing within medical and surgical research departments, but has not yet been widely implemented in plastic surgery. PCTs are similar to randomized controlled trials (RCTs) in that they both randomize patients to treatments and follow them prospectively after treatment. However, PCTs are less strict than RCTs in many ways: PCTs have fewer inclusion and exclusion criteria, to facilitate the recruitment of representative samples; use data collected during routine clinical care; and commonly rely on subjective patient-reported outcomes. PCTs offer many advantages over the standard RCT, including greater cost efficiency, larger sample sizes, and faster completion times. Because of these advantages, PCTs offer potential benefits to plastic surgery research efforts, but researchers must make intentional design choices when planning a PCT. Researchers should consider the ethics of their study question and treatment identification, appropriate randomization techniques, reliable plans to mitigate possible bias, and minimal but sufficient follow-up plans.