Review by Cary Gross – 10/22/2019 – 5:17pm

Data Request Number: 2019-4001 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 proposal indicates “I am not analyzing participant-level data” but the analytic plan suggests that this is not the case. For instance: “Individual subject level data from the requested study will be screened…and “…. Kaplan-meier survival curves will be generated, within PS quintiles….”
Are the outcomes (Oswestry Disability Index score, assessment for neurologic deficit, receipt of additional surgical intervention) all incorporated into the HEALOS database?

Recommendation for this data request: Not Approve

see comments above.