BTRIS: The NIH Biomedical Translational Research Information System

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BTRIS The NIH Biomedical Translational Research
Information System

• James J. Cimino
• Chief, Laboratory for Informatics Development
• NIH Clinical Center

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National Institutes of Health Clinical Center
In-patient beds - 234
Day hospital and out-patient facilities
Active protocols - 1800
Terminated protocols - 7100
Clinical researchers - 4700
All patients are on a protocol
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Clinical Data at NIH
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Clinical Data at NIH
Institute System
Personal System
EHR
Lab System
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Clinical Data at NIH
Institute System
Personal System
EHR
Lab System
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Biomedical Translational Research Information
System (BTRIS)
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Architecture

• Data acquisition
• Database
• Controlled terminology
• User data entry
• Search tool

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Data Model

• Store similar data in main tables
• Store extra data in generic tables
• Can promote from generic to main table
• Preserve original meanings
• Queries based on concepts of the users

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Research Entities Dictionary (RED)
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Research Entities Dictionary (RED)
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Research Entities Dictionary (RED)
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Research Entities Dictionary (RED)
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BTRIS Two Applications
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BTRIS Two Applications
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BTRIS Two Applications
BTRIS Data Access
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What is in BTRIS?

• Clinical Center MIS (1976-2004) and CRIS (2004-)
• Demographics
• Vital signs
• Laboratory results
• Medications (orders and administration)
• Problems and diagnoses
• Reports (admission, progress, discharge,
  radiology, cardiology, PFTs)
• National Institute of Allergy and Infectious
  Disease
• Medication lists
• Laboratory results
• Problems
• National Institute of Alcohol Abuse and
  Alcoholism
• Clinical assessments

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BTRIS Data Growth
M i l l i o n s o f R o w s
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BTRIS Data Access

• Lists
• Individual Lab Test
• Lab Panels
• Medications
• Subjects
• Vital Signs

• Reports
• IRB Inclusion
• CBC Panel
• Chem 20
• Microbiology
• Demographics
• Individual Lab
• Lab Panels
• Medications
• Vital Signs
• Diagnoses/Problems

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33 years of Data
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BTRIS Reports per Week
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BTRIS Users and Subjects
115 BTRIS Users thru March 2010
(of 395,005 attributions, or 20.27)
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Subject-Protocol Attributions

• 395,005 total attributions
• 126,533 verified by Medical Records
• 44,142 verified by IC systems
• 1,966 verified by users
• 363 unverified subjects not on protocol
• 236 verified subjects not on protocol

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Re-using Data in De-Identified Form

• Look for unexpected correlations
• Pose hypothetical research questions
• Determine potential subject sample sizes
• Find potential collaborators

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Access to De-identified Data

• De-identified data available to NIH intramural
  research community
• NIH researchers wanted access policy to ensure
  protection of intellectual property and first
  rights to publication
• Resolved through three means
• Association of data with an NIH PI
• Status of protocol
• Age of data

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Access to De-identified (Coded) Data
a) Data Outside Any Protocol Period
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Data Available for De-Identified Reports
Not attributed to any protocol 249,128
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Data Available for De-Identified Reports
Available Subjects 285,595 (66.4)
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OHSR Exemption Process

• Required for all de-identified data queries
• Automated process replaces OHSR Form 1 paper
  process for exemption

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Serum Albumin Trends
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Using BTRIS For Clinical Research
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Re-using BTRIS For Clinical Research
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Informatics Challenges

• Understanding data sources
• Finding the right balance for unified data model
• Modeling in the Research Entities Dictionary
• Organizing the Research Entities Dictionary
• Understanding researchers information needs
• User interface (including Cognos customization)
• Keeping up with report requests
• Integration into multiple research workflows
• Access to deidentified data
• New policies on contribution and use

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So What?

• Easier access to protocol data from EHR
• Easier access to archived data
• Protocol data integrated from multiple sources
• User empowerment
• Concept-based queries
• Data feeds to institute systems
• Data model flexible but not too flexible
• Rapid development timeline (under budget)
• User adoption can be considered good
• High user satisfaction
• Success with NIH policy
• Success with data sharing

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Future Directions

• Finish historical data
• Add more institutes and centers

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Future Directions

• Finish historical data
• Add more institutes and centers

• Images
• -omic data
• Specimen identification and location
• New reports and analytic tools
• Clinical Trials.gov reporting
• Beyond NIH

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btris.nih.gov
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btris.nih.gov