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BTRIS: The NIH Biomedical Translational Research Information System

BTRIS: The NIH Biomedical Translational Research Information System. James J. Cimino Chief, 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.

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BTRIS: The NIH Biomedical Translational Research Information System

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  1. BTRIS: The NIH Biomedical Translational Research Information System James J. Cimino Chief, Laboratory for Informatics Development NIH Clinical Center

  2. 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

  3. Clinical Data at NIH Institute System Personal “System” EHR Lab System

  4. Clinical Data at NIH Institute System Personal System EHR Lab System

  5. Clinical Data at NIH BTRIS Institute System Personal System EHR Lab System

  6. Biomedical Translational Research Information System (BTRIS) Data Standards (RED) Data Access Preferences Security Database

  7. NIAAA NIAID 33 CRIS, MIS

  8. Architecture Data acquisition Database Controlled terminology User data entry Search tool

  9. 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

  10. Research Entities Dictionary (RED)

  11. Research Entities Dictionary (RED)

  12. Research Entities Dictionary (RED)

  13. Research Entities Dictionary (RED)

  14. BTRIS – Two Applications

  15. BTRIS – Two Applications

  16. BTRIS – Two Applications BTRIS Data Access

  17. 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

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

  19. BTRIS Data Access Reports 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

  20. 33 years of Data

  21. BTRIS Reports per Week

  22. BTRIS Users and Subjects 130 Non- BTRIS PIs 245 BTRIS Beneficiaries + = 80,073 Attributed Subjects 619 Unique Protocols 115 BTRIS Users thru March 2010 (of 395,005 attributions, or 20.27%)

  23. 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”

  24. Re-using Data in De-Identified Form • Look for unexpected correlations • Pose hypothetical research questions • Determine potential subject sample sizes • Find potential collaborators

  25. 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

  26. Access to De-identified (Coded) Data b) Terminated Protocol – PI Gone c) Terminated Protocol – PI at NIH d) Active Protocol d) Active Protocol a)Data Outside Any Protocol Period

  27. Data Available for De-Identified Reports Total Subjects: 430,196 Attributed to Protocol: 181,068 Terminated > 5 yrs: 36,467 Not attributed to any protocol: 249,128

  28. Data Available for De-Identified Reports Available Subjects – 285,595 (66.4%)

  29. OHSR Exemption Process Required for all de-identified data queries Automated process replaces OHSR “Form 1” paper process for exemption

  30. Serum Albumin Trends

  31. Using BTRIS For Clinical Research Identify Potential Controls Identify Potential Subjects Obtain Clinical Data Potential Control Cases Potential Subject Cases Include Cases with Pathology Specimens Control Cases Specimens Obtained from Pathology Department Subject Cases Assign Case Numbers Send Case Numbers and MRNs to Pathology SNPs Sequenced Deidentify Cases Deidentified Subject Cases with Phenomic and Genomic Data Deidentified Controls Cases with Phenomic and Genomic Data

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