A Critical Look at a Diabetic Foot Randomized Controlled Trial: Can You Ever Have Too Many Patients?

The objective of this article series is to teach approaches for critical appraisal to consumers of medical literature. The aim is to build a deeper understanding of standard procedure in clinical research so clinicians can determine whether medical evidence can be applied to their practices. We will choose published articles with methodological flaws to serve as discussion points. In the first article of this series, we will proceed section by section through an article to teach readers what is usually reported, and illustrate what was done correctly and what was not. Subsequently, later articles in this series of critical appraisals will discuss more focused topics. There were several interesting flaws in our first examined paper. This study provides the unusual flaw of reporting a sample size justification and then exceeding enrollment. In addition, the authors enrolled a relatively large number of subjects (n = 16) that evidently completed the study but were subsequently excluded from analysis because they did not fit the inclusion and exclusion criteria.