LAUSR

Dear Editor We thank you for the opportunity to respond to Gao X and Cai X’s letter regarding our article, Can We Trust the Conclusion ‘‘No Significant Difference’’ in Plastic Surgery Trials? [1]. We believe that the authors missed our point. In our discussion there was no mention or suggestion that ‘‘negative clinical results are often due to insufficient sample sizes.’’ Our paper was targeting randomized controlled trials (RCTs) measuring efficacy in plastic surgery. Our article focused on a very specific point, which is avoiding type two error when conducting a RCT in plastic surgery. When underpowered RCTs conclude no difference between the two tested interventions, they are at a high risk for type two error (false negative). We are very aware of the unique challenges in the execution of RCTs in surgical specialties [2]. These challenges are generally only applicable if the intervention is surgical. These challenges unique to surgical RCTs include, but are not limited to, surgical equipoise, surgeon performance, and learning curve when the intervention is surgical technique, differential care, concealment, and blinding. There are situations that RCTs design may not be feasible, but in many other circumstances they are doable. A few key examples are the use of nitropaste in compromised mastectomy skin flap [3], tranexamic acid in rhinoplasty [4], wise pattern vs inverted ‘‘T’’ breast reduction, [5] and examining injectables [6]. There are key times when interventions should be tested using an RCT design, particularly when completing drug studies. As an example, at our institution we are currently completing an RCT investigating the use of polyethylene glycol to improve sensory recovery following peripheral nerve injuries. In this case, an RCT is certainly feasible as it is a controlled environment, double blinding is possible, the sample size can be captured at a single center, and the study is examining an off-label use of a well-known drug. Should the study examine a well-known procedure that is currently standard of care and blinding is not possible, then another type of study may be best. We know that an RCT design is not common but that does not mean they are not feasible in certain circumstances. In fact, the number of RCT publications are on the rise but despite the increase in number their quality may not be adequate [7]. Some key things to improve the quality of RCTs are increasing the sample size by making trials multicenter, having statisticians involved in the data analysis, establishing data points and sample sizes a priori, and completing appropriate blinding and allocation concealment [7]. Only when RCTs are feasible should they be completed following the necessary guidelines. In summary, there is a noticeable improvement in the quality of the evidence in the recent years and the number of RCTs is increasing. However, we need to continue focus on the performance of RCTs within our specialty to better inform patient care. RCTs have the potential to truly change our practice with attention to detail. Plastic surgeons should be wary of completing RCTs without the help of methodologists/statisticians and should follow & Osama A. Samargandi [email protected]