Review by Joseph Ross – 11/06/2017 – 2:37pm

Data Request Number: 2017-2326 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):

It would be useful to provide more information on the newly developed Global Patient-Reported Outcome Measure (G-PROM), including a reference publication or poster. While the project is quite interesting and feasible, the protocol could be strengthened by providing more information on what information is accounted for in the G-PROM (beyond AEs, the DAS28, and the ACR20, 50 and 70), including how each of the efficacy and safety outcomes are weighted. Also, is the DAS28 the outcome used for the G-PROM, or the change from baseline in DAS28?

Recommendation for this data request: Approve