Review by Nihar Desai – 04/06/2019 – 1:46pm

Data Request Number: 2019-3840 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?: Unsure, further clarification from requestor is needed Can the proposed research be reasonably addressed using the requested data?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

My main concern about this proposal centers on study power.  If the Afib rate is 10%, how many new onset Afib will they have? Parenthetically, using SAE/AE terms to find Afib will be challening.  It is not adjudicated (so you don’t know if the Pt really had afib) and not systematically collected. On top of this, with limited “N” how can you really have so many covariates…

Recommendation for this data request: Not Approve