btris: the nih biomedical translational research information system
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BTRIS: The NIH Biomedical Translational Research Information System
James J. CiminoChief, Laboratory for Informatics Development
NIH Clinical Center
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
Clinical Data at NIH
EHR
InstituteSystem
Lab System
Personal“System”
Clinical Data at NIH
EHR
InstituteSystem
LabSystem
PersonalSystem
Clinical Data at NIH
EHR
InstituteSystem
LabSystem
PersonalSystem
BTRIS
Biomedical Translational Research Information System (BTRIS)
Database
DataStandards
(RED)
DataAccess
SecurityPreferences
CRIS, MIS
33NIAIDNIAAA
Architecture
• Data acquisition
• Database
• Controlled terminology
• User data entry
• Search tool
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
Research Entities Dictionary (RED)
Research Entities Dictionary (RED)
Research Entities Dictionary (RED)
Research Entities Dictionary (RED)
BTRIS – Two Applications
BTRIS – Two Applications
BTRIS – Two Applications
BTRISData Access
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
BTRIS Data Growth
Millions
of
Rows
BTRIS Data AccessReports
• IRB Inclusion• CBC Panel• Chem 20• Microbiology• Demographics• Individual Lab• Lab Panels• Medications• Vital Signs• Diagnoses/Problems
Lists• Individual Lab Test• Lab Panels• Medications• Subjects• Vital Signs
33 years of Data
0
50
100
150
200
250
300
350
400
6/1/
1976
6/1/
1978
6/1/
1980
6/1/
1982
6/1/
1984
6/1/
1986
6/1/
1988
6/1/
1990
6/1/
1992
6/1/
1994
6/1/
1996
6/1/
1998
6/1/
2000
6/1/
2002
6/1/
2004
6/1/
2006
6/1/
2008
Albumin (g/dL)
Alkaline Phosphatase (U/L)
ALT/GPT (U/L)
Lactate Dehydrogenase (U/L)
0
200
400
600
800
Aug-09
Sep-0
9
Oct-0
9
Nov-09
Dec-0
9
Jan-1
0
Feb-1
0
Mar
-10
Apr-10
BTRIS Reports per Week
BTRIS Users and Subjects
115 BTRIS Users thru March 2010
130 Non-BTRIS PIs+ =
245 BTRIS Beneficiaries
619 UniqueProtocols
80,073AttributedSubjects
(of 395,005attributions,or 20.27%)
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”
Re-using Data in De-Identified Form
• Look for unexpected correlations
• Pose hypothetical research questions
• Determine potential subject sample sizes
• Find potential collaborators
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
d) Active Protocol
Access to De-identified (Coded) Data
a) Data Outside Any Protocol
Period
b) Terminated Protocol – PI Gone
c) Terminated Protocol –
PI at NIH
d) Active Protocol
Data Available for De-Identified Reports
Total Subjects: 430,196
Not attributed to any protocol: 249,128
Attributed to Protocol: 181,068
Terminated > 5 yrs: 36,467
Data Available for De-Identified Reports
Available Subjects – 285,595 (66.4%)
OHSR Exemption Process
• Required for all de-identified data queries
• Automated process replaces OHSR “Form 1” paper process for exemption
Serum Albumin Trends
Using BTRIS For Clinical ResearchIdentify
Potential Subjects
IdentifyPotential Controls
Include Cases with Pathology Specimens
SubjectCases
ControlCases
Assign Case Numbers
Potential SubjectCases
Potential ControlCases
Obtain Clinical Data
Deidentified SubjectCases with Phenomic and
Genomic Data
Deidentified ControlsCases with Phenomic and
Genomic Data
SpecimensObtained
from Pathology
Department
Send Case Numbers and MRNs to Pathology
SNPs SequencedDeidentify Cases
De-identifiedText Reports
and Other Data
Merging Records Manual Scrubbing
De-identifiedText Reports
Obtain Clinical Data
DeidentifiedSubject
Data
IdentifiedText
Reports
Perform Query in Identified
Form
Trusted Broker
Re-using BTRIS For Clinical Research
Office of Human Subjects Research
Develop Deidentified
Query
Investigator
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
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
Future Directions
• Finish historical data• Add more institutes and centers
CRIS, MIS
Radiology Images
Other CC Sources
33NIAIDNIAAA
NINDS
NIDDK
NINR
N HG
RI
NHLBI
NCI
Future Directions
• Images• “-omic” data• Specimen identification and location• New reports and analytic tools• Clinical Trials.gov reporting• Beyond NIH
• Finish historical data• Add more institutes and centers
btris.nih.gov
btris.nih.gov
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