The investigators propose to determine whether baseline cytokines can “predict outcomes to ustekinumab treatment”. However, their analytic plan, as written, will not address this aim. For instance, the independent variable is incorrectly specified, the manner in which treatment assignment group (i.e. ustekinumab or control arm) will be incorporated into the analysis is not mentioned, and the construction and analysis of the model is incomplete, mentioning only that AUC curves will be compared.
Not Approveincomplete and vague analytic plan