The Implementation of Randomization Requires Corrected Analyses. Comment on "Comprehensive Nutritional and Dietary Intervention for Autism Spectrum Disorder- Randomized, Controlled 12-Month Trial, Nutrients 2018, 10, 369"

Abstract

We commend Adams et al. [1] for undertaking a lengthy intervention with a randomized design. However, we have concerns about the implementation of the randomization and analysis of results. Using block randomization, the authors enrolled 37 participants to the treatment and 30 to the non-treatment groups. In response to our email asking how block randomization led to these discrepant group sizes, the corresponding author added that they balanced participants between high and low “ABA therapy” and by age, and paired siblings to the same treatment groups, then randomly assigned within each batch. We thank the author for communicating these details; however, this raises three specific concerns regarding the randomization and/or the extent to which the analyses used are correct given the randomization.