Review by Joseph Ross – 08/09/2017 – 5:15pm

Data Request Number: 2017-1966 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):

The authors propose what appears to be a useful study of the incidence and moderators of breakthrough antipsychotic maintenance medication (BAMM) in individuals adherent with long acting injectables. However, It would help if the authors provide a bit greater clarity as to what is meant by breakthrough antipsychotic maintenance medication (BAMM). This term was not familiar to me, and I do not find much when I search the literature for it. Does this mean “breakthrough psychotic episodes when adherent to antipsychotic maintenance medication”, or something else? From the proposal, it seems the authors use the term “relapse” interchangeably with “BAMM” – so is BAMM a relapse (or a breakthrough psychotic episode) while adherent to medication?
Outside of this point of clarification, the study proposal, variables to be used, and statistical analysis plan are well described.
One additional caution that may deserve consideration. The authors explain: “The source of data will be IPD provided by the YODA project for RCT on long acting risperidone and paliperidone. We plan to combine these with IPD of industry sponsored RCTs on long acting aripiprazole and olanzapine meeting the same inclusion criteria, which will be provided directly to us by the companies.”
Do the authors have permission to upload this data on to the SAS secure data sharing platform in order that it be combined with the RCT data available via the YODA Project?

 Recommendation for this data request: Approve