To the Editor We read with great interest the article by Cohen et al1 that compared the best medical treatment with gastric bypass for the remission of microalbuminuria in early-stage chronic kidney disease in patients with type 2 diabetes and obesity.
Knowing the difficulties of carrying out a randomized clinical trial involving surgical procedures, the study flowchart and data analysis always arouse our interest. What sparked our attention in this study was the maintenance of 5 patients (9.8%) who were not operated on in the gastric bypass group performing an intention-to-treat (ITT) analysis. Outcomes at 24 months (Table 2) were presented with the inclusion of these patients, except for albumin and creatinine ratio and metabolic control, which were also presented with the sole inclusion of “complete cases.” The decision to proceed with an ITT, “modified” ITT, or per protocol analysis is often a challenge.2,3