Review by Joseph Ross – 12/19/2019 – 11:06am

Data Request Number: No Data Request Assigned 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 Please use this space to provide any comments, feedback or concerns (optional):

Proposed study to compare FACIT-Fatigue and PROMIS Fatigue 10a individual item responses and scores over specific periods of follow-up. It would be useful, since it was not written explicitly, that the specific aims to examine floor/ceiling effects (distributions), internal consistency and convergent validity pre-specifiy which fatigue measure is focused on: FACIT-Fatigue or PROMIS Fatigue. Presumably, one is the “main endpoint” and the second is being used for the convergent validity aim. Or have I misunderstood?
Also, I was unclear why the authors pre-specified examination of the Crohn’s Disease Activity Index (CDAI), as the 2 trials requested are studies of patients with rheumatoid arthritis – I highly doubt the CDAI was collected. Perhaps this is a copy/paste error from another project?

Recommendation for this data request: Approve