Recommend approval pending clarification of two points in the analytic plan, which was challenging to follow. First, the outcome is listed as PCDAI, but the analytic plan suggests that change in each element of the PCDAI is the outcome. Second, the investigators state that “there is no independent variable that will be measured”. While that may be true, their analyses still will be using independent variables that they have obtained from these secondary data.
An additional point is simply for the investigators consideration: They should consider accounting for multiple comparisons, particularly if each element is being assessed with its own model.