1. The Biomedical Translational Research Information System (BTRIS) James J. Cimino Chief, Laboratory for Informatics Development National Institutes of Health Clinical Center Senior Scientist, Lister Hill Center for Biomedical Communications National Library of Medicine NLM Informatics Training Conference July 9, 2008

2. The Clinical Center, 1981

3. What Problem are We Trying to Solve? Patients in the NIH Clinical Center are on research protocols, but… …their data are in a clinical information system Need to extract individual data for analysis Need to do cross-patient queries for additional analysis

4. Patient Information Graphics System (PIGS) Integration of a desktop computer (pre-PC) to mainframe clinical information system (TDS) Download vital sign and drug administration data Various graphical displays SCAMC, 1981

8. The Columbia University Medical Center Clinical Data Warehouse Clinical data repository to collect data from ancillary systems Coded with the Medical Entities Dictionary Back end for clinical information systems Reorganized for use as Clinical Data Warehouse

9. How often are patient with the diagnosis of myocardial infarction started on beta blockers?

10. Find all patients with Diagnosis in class MYOCARDIAL INFARCTION AND with Medication in class BETA BLOCKER How often are patient with the diagnosis of myocardial infarction started on beta blockers? Find all patients with Diagnosis in class MYOCARDIAL INFARCTION

11. The Clinical Center, 2008

12. Patient data stored in EHR (Eclipsys) Need to extract individual data for analysis Need to do cross-patient queries for additional analysis Data may require transformation: –De-identification and Re-identification –Indexing –Aggregation by time –Abstraction by classification –Conversion to relevant concepts

13. What is BTRIS? Biomedical data –Research data collected using clinical information systems –Clinical data collected using clinical information systems –Research data from research information systems –Non-human data Reuse of data to support translational research Hence: Biomedical Translational Research Information System

14. The NIH, 2008

15. What is BTRIS? BTRIS

16. What is BTRIS? BTRIS

17. OntologyOntology Data Acquisition Processes Coding Indexing De-Identifying Permission Setting BTRIS What is BTRIS? Data Repository Data Retrieval Functions Authorization Subject-Oriented Cross-Subject Re-Identification NLP Data Analysis Tools Subject Recruitment Hypothesis Generation Hypothesis Testing

18. Queries from Requirements-Gathering Provide Medication lists at time of patient encounters. Include drug diaries for inpatient, outpatient and in-between encounters in the patient medical record. Include all chemo and non-chemo drugs from CRIS and IC systems Provide Medication administration documentation (drug diaries) with times as part of patient record Provide ability to compare patient results, Medication Administration Records between dates and/or encounters Provide drug randomization info, compliance records and drug accountability info for all investigational, study and prescription drugs Provide all Clinical Center lab results with times of specimen draws Provide external lab results Provide archival images Provide demographics data including age, BMI, race, gender, contact info, etc Provide access to genomics and bio-markers data Provide cumulative blood volumes, research drugs and radiation for subject over a given period Provide ability for ICs to feed expanded diagnosis/problem lists Provide searching and filtering patients' data by all diagnosis, tests, procedures, protocol & protocol classifications Standardize medication and lab test codes. Provide integration of adverse events data in the data warehouse, Provide integration of protocol census, status and subject accrual tracking data from Protrak in the data warehouse Provide ability to attribute different events to protocols, viz., consent signed, protocol activated, orders, observations, adverse events, etc Provide integration of staff, patient and user index data across source systems in data warehouse. Provide original informed consent, and updated consents for re-contact of patients for research for all protocols. Provide searchable consents and image of consents in database. Provide answers to: –Can tissues be used for cancer/genetic research, other research, germ line testing –Can patient be re-contacted for questions? Provide single patient amendments Provide access and track biological specimen data Provide access to Appointment Data Provide “Review of Systems” info for each patient visit. Provide patient de-identification services Standardize Units Of Measure

19. Ad Hoc Committees Principal Investigator User Group –Identify needs –Set priorities –Test-marketing Policy Working Group –Patient protection –Principal investigator protection

20. Demonstration Project – July 2008 All data on all patients in 29 protocols Multiple data sources and types Scrambled data, open to all Real, identified data open only to PIs Class-based and patient-list based queries Additional functions as available

21. BTRIS 1.0 – July 2009 Real database Expanded RED Expanded sources, all data on all patients Images Functions as per PI User Group and community

22. Source Data from Clinical Systems

23. BTRIS Data Model

24. Research Entities Dictionary (RED)

25. MRN BTRIS ID Identifiers 1234 B00001 John…. 1447 B00002 Mary…. 2347 B00003 Umberto... BTRIS ID Other Data B00001 Sodium 132 B00002 Sodium 143 B00003 Sodium 138 BTRIS Identified Data MRN Identifiers Other Data 1234 John…. Sodium 132 1447 Mary…. Sodium 143 2347 Umberto... Sodium 138 BTRIS ID Other Data B00001 Sodium 132 B00002 Sodium 143 B00003 Sodium 138 Deidentified Data Gender Avg Data Male Sodium 135 Female Sodium 143 Other Sodium 218 PIs NIH Researchers Patient Recruitment Non-NIH Researchers

27. Issues Patient ownership of de-identified data If genomic data are included, can we truly de-identify? Is protocol number a patient identifier? What data should not be shown to PIs? What is the extent of data control by PIs?

28. BTRIS Will: Be the preferred system to analyze NIH clinical and non-clinical data Aggregate and standardize disparate and isolated data sets Automate and streamline processes that are traditionally manual and cumbersome Prioritize data sources and functionality based on needs of user community

29. Moving Forward Despite centuries of clinical research, data are still fragmented Sophisticated terminology is the key to reuse of disparate data Policy issues are bigger than technical issues Future of BTRIS: today the NIH, tomorrow the world?

30. btris.nih.gov