Querying Four Decades of Clinical Research Data at

Querying Four Decades of Clinical Research Data at the National Institutes of Health James Cimino, MD, FACMI, FACP Laboratory for Informatics Development NIH Clinical Center and National Library of Medicine

Clinical Research Data at the NIH Institute System EHRs (CRIS/MIS) Lab System Personal System

Clinical Research Data at the NIH Institute System EHRs (CRIS/MIS) Personal System Lab System BTRIS* * The NIH Biomedical Translational Research Information System

What is in BTRIS? • • CRIS – Alerts – Allergies – Anatomic Pathology – Blood Bank – Clinical Documents (unstructured) – Clinical Documents (structured) – Demographics – Diagnoses/Problems – Echocardiograms – Electrocardiograms – Lab Tests and Panels (Location) • – Medication Administration – Medication Orders – Microbiology (Links to Mass Spec) – PDF Documents – Radiology Reports – Radiology Images – Vital Signs MIS – Blood Bank – Demographics – Lab Tests and Panels – Medications – Microbiology – Radiology Reports – Vital Signs Other institutes – NIAID (CRIMSON: Labs, Meds, Problems) – NIAAA (Assessments) – NCI (Labmatrix, C 3 D, Biospecimens) – NICHD (CTDB: Forms) – NHGRI (Labmatrix, Exome Data)

BTRIS Data Growth

Reports by Type

BTRIS Functions • Identified data: – Attribute subjects to protocols – Query for protocol-related data – Submit summary results to Clinical. Trials. gov

Click here to go to db. SNP

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1976 -2014: 39 years of Data

Using the Data for Quality Control The Department of Laboratory Medicine’s Clinical Chemistry section is experiencing a problem with magnesium (Mg) measurements on the main Clinical Chemistry analyzer. Values are lower than the true value…

BTRIS Functions • Identified data: – Attribute subjects to protocols – Query for protocol-related data – Submit summary results to Clinical. Trials. gov • De-Identified data – Human-mediated queries for complex data – Self-service “Limited Data Sets”

Limited Data Set Queries • Data types: – Demographics – Diagnoses – Laboratory results – Medications • Uses: – Quick “snapshots” of BTRIS contents – Preliminary analysis for protocol development – Estimates of availability of eligible subjects – Retrospective data study

Case Study 1 (self-service): Diagnoses Associated with Elevated B 12 Levels • What is the significance of an incidental elevation of vitamin B 12? • Query: – All subjects with B 12>999 – All Diagnoses – All B 12 levels

Case Study 1 (self-service): Diagnoses Associated with Elevated B 12 Levels

Case Study 1 (self-service): Diagnoses Associated with Elevated B 12 Levels

Case Study 1 (self-service): Diagnoses Associated with Elevated B 12 Levels

Case Study 2 (human-mediated): Drug-Induced Adverse Events • What is the correlation between a chemotherapeutic drug and adverse events over time? • Query: – All subjects with any dose of the drug – All systolic blood pressure < 90 mm. Hg

Case Study 2 (human-mediated): Drug-Induced Adverse Events

What Does Really BTRIS Add? • Centralization and curation of data • Centralization and curation of terminologies • Self-service tools • Clarification and operationalization of policies