Review by Joseph Ross – 11/21/2018 – 12:29pm

Data Request Number: 2018-3743 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Recommendation for this data request: Not Approve

This is a well conceived proposal to use data available via the YODA Project to examine changes in HRQoL in the context of receiving biologic treatment among patients with Crohn’s disease. However, certain aspects of the study should be clarified prior to approval, unless I’ve misunderstood. The outcome variable is clear ( changes in HRQoL), but the statistical analysis plan offers explanation for analyses dependent upon whether the outcome is continuous or categorical – isn’t the outcome a continuous variable. Also, there are instances in the proposal where examination of adverse events (harm) is discussed – but these outcomes are not defined. Finally, the investigators explain that no other variables of interest will be used or examined. But that seems unlikely. Will subgroup analyses by patient age, sex, disease severity, etc. not be pursued? Would suggest clarifying these points prior to approving the proposal.