Review by Joseph Ross – 06/28/2020 – 5:54pm

Data Request Number: 2020-4362 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):

Interesting re-analysis of data from 4 clinical trials to determine if the presence and type of stenosis at baseline impacts ability to achieve clinical and endocopic outcomes. However, main analyses appear to compare outcomes among patients without non-passable stenosis at baseline to those with non-passable stenosis, without accounting for other demographic and clinical variables that may be associated with clinical and endocopic outcomes. Analyses could be strengthened by risk-adjusting for important covariates.

Recommendation for this data request: Approve