Do Methodological Flaws Invalidate a Randomized Trial of Lifestyle Modification Programs in Obese Patients?

摘要

The article by Digenio and colleagues (1) has several methodological errors. Can we trust the results of a trial in which patients were randomly assigned inappropriately, patient withdrawals substantially shrank the cohort, the “modified” intention-to-treat analysis did not account for the many patients who withdrew, and the analysis was based on distributional and other assumptions that could not possibly be true? This is a bit hard to swallow.