Some Random(ized) Thoughts.

In this EBM Hub edition, we use the interesting, prospective, randomized, double-blinded study of Min et al from this current issue of Aesthetic Surgery Journal as a springboard to address a key methodological issue that is important in the proper execution and reporting of a randomized, controlled trial: themethod of randomization. Randomization is among our most powerful protective mechanisms for removing bias from a study. A well-performed randomization makes it more likely that the study conclusions will be valid. Randomization works by reducing the chance that our preknowledge of certain factors will influence how the study is performed, specifically that our pre-knowledge of patient factors does not influence which patients get which treatments, or that we might perform the treatments differently based on such knowledge. Investigators, reviewers, and journal editors put a lot of emphasis on the method of randomization, and as a reader, so should you. Why? How much difference can it make? With trials, a small error at one point (eg, randomization) multiplies another error at another point, and so on, therefore, several small errors can lead to a totally wrong, backwards result. (Two other tools, blinding and allocation concealment, also prevent preknowledge from influencing how trials are performed and assessed. Click on the following link to learn more about how blinding and allocation concealment work alongside randomization: http://youtu.be/znBuDyMjhTM) When performing a randomized trial, it is important that the authors describe how the randomization process was performed, and the more detail provided the better the reader is assured of the integrity of the process. If you are planning a study or just reading and assessing one, be sure to think about the how, when, and who of your randomization process.