sentinel initiative public workshop - brookings institution · 2016. 7. 31. · feasibility/test...

Sentinel Initiative Public Workshop

The Brookings Institution

Marriott at Metro Center • Washington, DC

Tuesday, January 14, 2014

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Sentinel Initiative Public Workshop Panel: Overview of Enhancements

Underway to Mini-Sentinel

Overview of changes in Mini-Sentinel data querying capacity, tools, systems and data

Jeffrey Brown, PhD, Lesley Curtis, PhD

for the Mini-Sentinel Data Core

January 14, 2014

Mini-Sentinel Operations Center (MSOC)

MSOC Data Group

Infrastructure Programming Distributed Database &

Communications

Production

Data Group staff, other HPHC staff, RSDC, external programmers, vendors, data partners support each team

Management, Oversight, and Strategic Planning

Planning Finance Project Management Science Methods

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Growing demands require ongoing system upgrades and expansion of capabilities

Increased use of rapid response querying

New types of surveillance (eg, PROMPT)

More workgroups expanding into new areas

• Laboratory results

• Inpatient data

• External linkages

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System Upgrades (selected)

Standard operating procedures

Standardization to improve throughput and support reporting tools

Secure infrastructure

Query tracking and query metadata tracking

Mechanisms to bring lessons learned and network information closer to the investigators

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Distributed query tool

Software to enable secure distributed querying

Now used by NIH, PCORI, and others to build networks

New features • Improve query tracking and reporting functions • Query metadata searching (who has queried what) • Rapid data characterization queries across data partners

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DP 3

Sample data (influenza)

Data checking query: Diagnosis code review

Quickly investigate codes by partner

DP 1 DP 2 DP 3

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Expansion of Modular Program Capabilities (selected)

Attrition tables in standard output

Availability of laboratory results

Incidence risk ratio from Modular Program results

Event rate during concomitant medication use

Highly-flexible exposure and outcome definitions (Combo Tool)

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Testing environment and processes

Query creation and report processing

Add new data elements into existing tools

Query metadata capture and reporting

Streamline request execution

Report automation

Training material (videos, documentation)

Planned Enhancements

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Develop an active surveillance system for regulated blood component and blood- derived product use

Identify and verify potential safety concerns

• Recipient safety

• Non-infectious complications

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Blood Safety Continuous Active Surveillance Network (BloodSCAN)

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Feasibility/Test Case Evaluation

Identify data sources

• Inpatient electronic health data with blood components & blood-derived products

Evaluate the granularity and completeness of the inpatient data

Transform relevant data elements into a Common Data Model

Test this data source using an exposure outcome pair that would occur during a single hospitalization

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Hospital Corporation of America

Hospital Corporation of America

162 hospitals 4-5% of all inpatient care in US 20 states

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Hospital Corporation of America Test Case

Goal: Evaluate rates of transfusion-related acute lung injury (TRALI) after transfusion of red blood cells, platelets and plasma, using inpatient EHR data

Exposure: red blood cells, platelets, plasma

Outcome: TRALI

• TRALI occurs within first 6 hours after a transfusion

Chart confirm exposure and outcome

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Ongoing Work

Create and populate new inpatient data tables in the Mini-Sentinel Common Data Model

• These will apply to other potential sources of inpatient EHR data

• Capture inpatient blood component and blood-derived product data

Test case: assess incidence of TRALI after blood component transfusion

Assess utility of new inpatient data

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Establish a national system for active vaccine safety surveillance within Mini-Sentinel

Address key gaps in existing vaccine safety monitoring capabilities • Building capacity to study the safety of vaccines in pregnant

populations

Post-licensure Rapid Immunization Safety Monitoring system (PRISM)

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Vaccine Safety in Pregnancy

Our knowledge of the safety of medication and vaccine use during pregnancy is limited

Birth certificate and fetal death report data provide information on factors that may affect adverse pregnancy outcomes and birth outcomes

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Immunization Registries

PRISM Data Partners

IR1

IR2

IR3

IR4

IR5

IR6

IR7

IR8

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Immunization Registries

Birth/Fetal Death Registries

PRISM Data Partners

IR1

IR2

IR3

IR4

IR5

IR6

IR7

IR8

BR1

BR2

BR3

BR4

BR5

BR6

BR7

BR8

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Current Progress and Ongoing Work

Developed standard file structures for birth and fetal death data

Linkage accomplished for 2 states

• Assessment of matching underway

Linkage with 8 immunization registries completed

• Assessment of contribution of immunization registries underway

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Thank you