[email protected] PopMedNet in Mini-Sentinel Tiffany Siu Woodworth PopMedNet User Group...
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[email protected] 1 PopMedNet in Mini-Sentinel Tiffany Siu Woodworth PopMedNet User Group Conference July 27, 2015
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Transcript of [email protected] PopMedNet in Mini-Sentinel Tiffany Siu Woodworth PopMedNet User Group...
PopMedNet in Mini-Sentinel
Tiffany Siu Woodworth
PopMedNet User Group ConferenceJuly 27, 2015
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
Mini-Sentinel Partner Organizations
Institute for Health
Lead – HPHC Institute
Data andscientific partners
Scientific partners
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
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
Distributed via PopMedNet
Programs upload to Secure Portal& emails sent to Data Partners with
file location
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
Future Enhancements
To date, distributed over 750 data requests
Hundreds of users at Operations Center and Data Partner sites
Multiple ongoing projects and assessments with various funding sources
Many, many more requests to come!
Soon to add more users, including FDA and Scientific Partners
Focus on improving tracking and accounting capabilities
Future Enhancements: WorkflowFull Query Fulfillment Standard Operating Procedure
Prepare Specifications
Prepare Request Package
Run Request Package
DraftReport
Future Enhancements: Workflow (2)
Finalizeand Send
Report
Query Fulfillment Process (Simplified)
Distribute package to Data Partners
Receiving data from Data Partners
Receive final programspecifications
Send final report / complete request
Web-based request form
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
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)
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
