Review by Joseph Ross – 09/01/2021 – 4:07pm

Data Request Number: No Data Request Assigned 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?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

The investigators have submitted a data request to use data from two trials as part of a systematic review and meta-analysis of double-blind randomized controlled trials to characterize adverse events associated with acetylcholinesterase inhibitor use. I have a number of questions:
1. Will the investigators be using IPD or just the summary data (IPD are requested, but the purpose is described as ‘summary-level data meta-analysis’)?
2. Will the investigators be conducting a broad search of the literature to identify trials? Selecting just these two for analysis seems limited, but no additional trials are mentioned.
3. What adverse events will be studied? There is no pre-specification. At various points in the proposal, terms used include ‘adverse events’, ‘psychiatric adverse events’, and ‘neuropsychiatric symptoms like headache or dizziness’. Please pre-specify.
4. Related to the prior point, how will ‘symptom clusters’ be defined? Please pre-specify.
5. Would recommend pre-specifying which other variables will be used to stratify analyses, beyond sex and age. Please specify what ‘specific diseases’ and ‘previous illnesses of participants’ will be studied.
Much more detail is needed, as the goal of proposals submitted to the YODA Project for data re-use are to enable outside investigators/peer reviewers to have a reasonable sense of what will be done with the data so that a finished project can be assessed against what was proposed.

Recommendation for this data request: Not Approve

Please see above