Review by Joseph Ross – 08/18/2015 – 3:10pm

Data Request Number: 2015-0556 Please use this space to provide any comments, feedback or concerns (optional):

Please clarify what is meant by operating characteristics – are these the scores described (PRO, CEDIS, SES-CID) or some other measure of endoscopy quality. I found this very hard to understand.
Please clarify the different measures (PRO, CEDIS, SES-CID). Why would one be different than another?
How many different raters will be involved in estimating the intra- and inter-rater reliability? It appears that SONIC data will be the source for this aspect of the study, but few details are provided on how this testing will take place.

Recommendation for this data request: Not Approve

Need to first confirm that the data requested is available. I suspect it is not.