The Biomedical Translational Research Information System (BTRIS)

James J. CiminoChief, Laboratory for Informatics Development

National Institutes of Health Clinical Center

Senior Scientist, Lister Hill Center for Biomedical CommunicationsNational Library of Medicine

NLM Informatics Training ConferenceJuly 9, 2008

The Clinical Center, 1981

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

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

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

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

2003 2004 2005 2006 2007

MIMI+Beta

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

The Clinical Center, 2008

The Clinical Center, 2008• 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

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

The NIH, 2008

What is BTRIS?

BTRIS

What is BTRIS?

BTRIS

O n t o l o g y

Data Acquisition ProcessesCoding Indexing De-Identifying Permission Setting

BTRIS

What is BTRIS?

Data Repository

Data Retrieval FunctionsAuthorization Subject-Oriented Cross-Subject Re-Identification NLP

Data Analysis ToolsSubject Recruitment Hypothesis Generation Hypothesis Testing

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

Ad Hoc Committees

• Principal Investigator User Group– Identify needs– Set priorities– Test-marketing

• Policy Working Group– Patient protection– Principal investigator protection

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

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

Source Data from Clinical Systems

BTRIS Data Model

has

has

is a

is acan be

SubjectLivingSubject ID

Lab TestProtocol ID (FK)Encounter Date (FK)Person ID (FK)LivingSubject ID (FK)

Substance AdministrationProtocol ID (FK)Encounter Date (FK)Person ID (FK)LivingSubject ID (FK)MedicationType

Protocol SubjectProtocol ID (FK)Person ID (FK)LivingSubject ID (FK)

AllergyProtocol ID (FK)Encounter Date (FK)Person ID (FK)LivingSubject ID (FK)

Diagnostic ImagingProtocol ID (FK)Encounter Date (FK)Person ID (FK)LivingSubject ID (FK)

ObservationProtocol ID (FK)Encounter Date (FK)Person ID (FK)LivingSubject ID (FK)

ProviderProtocol ID (FK)Encounter Date (FK)Person ID (FK)LivingSubject ID (FK)Provider Type

Clinical DocumentProtocol ID (FK)Encounter Date (FK)Person ID (FK)LivingSubject ID (FK)

Adverse EventProtocol ID (FK)

Episode of CareVisit IDVisit Type

EncounterProtocol ID (FK)Encounter DatePerson ID (FK)LivingSubject ID (FK)Visit ID (FK)Visit Type (FK)

Primary InvestigatorProtocol ID (FK)Person ID (FK)LivingSubject ID (FK)

ProtocolProtocol ID

ConsentProtocol ID (FK)Person ID (FK)LivingSubject ID (FK)

ContactsPerson ID (FK)LivingSubject ID (FK)

PersonPerson IDLivingSubject ID (FK)

Research Entities Dictionary (RED)

MRN BTRIS ID Identifiers

1234 B00001 John….1447 B00002 Mary….

2347 B00003 Umberto...

BTRIS ID Other Data

B00001 Sodium 132B00002 Sodium 143

B00003 Sodium 138

BTRIS

Identified DataMRN Identifiers Other Data

1234 John…. Sodium 1321447 Mary…. Sodium 143

2347 Umberto... Sodium 138

BTRIS ID Other Data

B00001 Sodium 132B00002 Sodium 143

B00003 Sodium 138

Deidentified DataGender Avg Data

Male Sodium 135Female Sodium 143

Other Sodium 218

PIs NIHResearchers

PatientRecruitment

Non-NIHResearchers

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?

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

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?

btris.nih.gov