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PopMedNet in Mini-Sentinel Tiffany Siu Woodworth PopMedNet User Group Conference July 27, 2015 msoc@harvardpilgrim.org 1 Mini-Sentinel An FDA-funded pilot project, operating under FDA’s public health authority Scientific operations for an active medical product safety surveillance Continuous access to electronic healthcare databases msoc@harvardpilgrim.org 2 Mini-Sentinel Partner Organizations Lead – HPHC Institute Data and scientific partners Scientific partners Institute for Health msoc@harvardpilgrim.org 3 Mini-Sentinel Distributed Database 178 million individuals* • 358 million person-years of observation time 36 million individuals have over 3 years of data 31 million individuals with at least 1 laboratory results 4 billion dispensings 4.1 billion unique encounters, including 42 million inpatient stays 48 million currently accumulating data *As of July 2014. Potential for double-counting exists if individuals moved between data partner health plans msoc@harvardpilgrim.org 4 Early Use of PopMedNet in Mini-Sentinel Major goal of Mini-Sentinel – rapid response • Summary Tables – simple and rapid menu-driven querying of pre-populated summary tables • “Modular Programs” – Reusable, modular SAS programs Programs upload to Secure Portal & emails sent to Data Partners with file location msoc@harvardpilgrim.org Distributed via PopMedNet 5 Current Use of PopMedNet Query fulfillment and distribution of requests • All data requests sent via PopMedNet, including: – Summary Table Requests – SAS Program Packages “Modular Programs” Custom SAS programs Quality assurance programs – Data Partner Surveys Tracking data requests • Data Partner response time • Number of requests msoc@harvardpilgrim.org 6 Future Enhancements To date, distributed over 750 data requests Many, many more requests to come! Hundreds of users at Operations Center and Data Partner sites Soon to add more users, including FDA and Scientific Partners Multiple ongoing projects and assessments with various funding sources Focus on improving tracking and accounting capabilities msoc@harvardpilgrim.org 7 Future Enhancements: Workflow Full Query Fulfillment Standard Operating Procedure msoc@harvardpilgrim.org 8 Future Enhancements: Workflow (2) Query Fulfillment Process (Simplified) Prepare Specifications Prepare Request Package Run Request Package Draft Report Finalize and Send Report Web-based request form Distribute package to Data Partners Receive final program specifications msoc@harvardpilgrim.org Send final report / complete request Receiving data from Data Partners 9 Future Enhancements: Meta-data Increasing the amount of meta-data associated with each request to track and record: • • • • Dates associated with all parts of the request process FDA division Funding source Level of effort Transparent system with FDA Improved communications with Data Partners Clearer auditing system msoc@harvardpilgrim.org 10 Future Enhancements: Reporting Queriable database of request meta-data • Ability to create custom reports of requests by any combination of meta-data fields • Examples, reports by: – – – – Data Partner Request type Funding source Requesting division Future goal: Common reports automatically generated (e.g., monthly reports) msoc@harvardpilgrim.org 11 Recap Sentinel will continue to expand • More collaborators (scientific, data, FDA) • Increased number of requests PopMedNet will be instrumental in the organization of Sentinel’s network activity msoc@harvardpilgrim.org 12 Thank you! msoc@harvardpilgrim.org msoc@harvardpilgrim.org 13