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PopMedNet in Mini-Sentinel
Tiffany Siu Woodworth
PopMedNet User Group Conference
July 27, 2015
[email protected]
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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
[email protected]
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Mini-Sentinel Partner Organizations
Lead – HPHC Institute
Data and
scientific
partners
Scientific
partners
Institute for
Health
[email protected]
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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
[email protected]
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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
[email protected]
Distributed via
PopMedNet
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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
[email protected]
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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
[email protected]
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Future Enhancements: Workflow
Full Query Fulfillment Standard Operating Procedure
[email protected]
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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
[email protected]
Send final report /
complete request
Receiving data
from Data Partners
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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
[email protected]
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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)
[email protected]
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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
[email protected]
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Thank you!
[email protected]
[email protected]
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