James E. Tcheng, MD, FACC, FSCAI, FESC Professor of Medicine

Professor of Community and Family Medicine (Informatics) Duke University Health System

Brief informatics primer ◦ what is a (common) data element (CDE)?

CV Endpoints Project (R24FD004411-01) ◦ what it is (and isn’t) ◦ timelines, next steps

Syntactic

The ability of two or more computer systems to exchange information and use the information that has

been exchanged (IEEE, 1990).

Semantic

HCV status:

Question or prompt May have associated controlled

terminology

Value, result or answer May have associated controlled

terminology

Data Element May have associated controlled terminology

• A data element is a question – value pair • Considered the smallest meaningful unit of data exchange • Formally defined in ISO/IEC 11179-1 and 11179-3 • Typically has a unique identifier, a definition, attributes, valid values • Interpretation requires context (e.g., date/time of collection, method of measurement, or person, place or thing to which the data pertains)

Definition ◦ Clinical, contextual

Name ◦ Preferred name, clinical name, computational name,

short display name, aliases, synonyms Attribute set ◦ Units, data type, how measured, purpose (use case),

value set, links (relational, knowledge …), coding instructions, authoritative source / citation

Class membership, ontology relationships, use case modeling …

9 Oct 2009 5

Tagged Values Name: HL7 RIM Value:RIM Mapping: observation.value Condition: Where observation.code = "heart failure class" Tagged Values Name: CDISC SDTM CDISC SDTM: FA.FATESTCD = HFCLASS, FA.FATEST = Heart Failure Class, FA.OBJ = Heart Failure WHERE MH.TERM = Heart Failure Tagged Values Name: CADSR Local Value Domain Value: NYHAClassType Tagged Values Name: Property Concept Code Value C-##### Tagged Value: PropertyConceptPreferredName Value Type Tagged Value: Name: PropertyQualifierConceptCode1 Value C#####

Heart Failure \ NYHA Class Class

Name

Alias

Citation

Coding Instructions

Vocabulary

Definitions

Representa-tion Maps Avoid Qualifiers

- Pre-procedure…

- Most recent... - Date of…

Nahm M, McCourt B. 2011

Type

Built on the Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials (Hicks KA, Hung JM, Mahaffey KW, Mehran R, Nissen SE, Stockbridge NL, Targum SL, Temple R et al.)

Converting CV Endpoint concepts into CDE’s ◦ death (cause attribution), myocardial infarction,

stroke/TIA, PCI concepts, PVI concepts, heart failure event, unstable angina admission

Aim 1: Convert into structured data concepts ◦ “The Spreadsheet”: term, definition, allowed values

(value set), value definitions, authoritative references

Data element: myocardial infarction, acute

Concept definition: clinical syndrome where there is evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia

Data type: categorical, unique

Data format: text

Permissible values: Type 1: spontaneous; Type 2: ischemic imbalance; Type 3: death, no biomarkers; Type 4a: PCI-related; …

Permissible value definitions: (Type 1): Spontaneous clinical syndrome related to atherosclerotic plaque rupture … This classification requires a) detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value >99th percentile of the upper reference limit (URL) and b) at least one of the following: ◦ -- symptoms of myocardial ischemia ◦ -- new or presumed new significant ST-segment–T wave (ST–T) changes or new left bundle branch

block (LBBB) on the ECG … ◦ -- … development of pathological Q waves on the ECG ◦ -- imaging evidence of new loss of viable myocardium or new regional wall motion abnormality ◦ -- identification of an intracoronary thrombus by angiography or autopsy.

Aim 2: Develop and model the attributes in the CDISC SDTM ◦ Heads-down technical work ◦ Enabler of uniform electronic data

transmission

Aim 3: Develop use case examples to illustrate application of the SDTM

Example 1: Subject 40201 has history of myocardial infarction in September 2005. He presented on June 6, 2010 with chest pain of 4 hours duration. Initial ECG showed ST segment elevation in the anterior leads. He was taken immediately to the catheterization laboratory for emergency cardiac catheterization and angioplasty. This documented 100% occlusion of the mid left anterior descending artery with an image consistent with thrombus, and he underwent successful angioplasty. Subsequent biomarkers were positive for myocardial infarction.

What this is: ◦ Clinical and computational specifications for CV

Endpoint concepts for semantic interoperability Human (language) and computer (electronic)

◦ ~125 CV Endpoint data element concepts 2 levels (CV Endpoint, components of CV Endpoint) Based on published literature

>85% summative (judgment) Limited number of atomic CDE’s

For both investigator and CEC reporting For all disease states / all therapeutics (and potentially

surveillance, clinical / EHR use, CER, HSR, …)

What this is not: ◦ CRF ◦ CRF specifications But building a db with these specifications

should reduce complexity ◦ Complete set of atomic CDEs needed for

fully qualifying CV Endpoint events Would take >500 CDE’s

Next steps ◦ Work product nearly complete Final review and QI ◦ Posting artifacts – late 2013 ◦ ACC/AHA Task Force on Data Standards

publication – spring 2014 ◦ Building, modeling as HL7 RIM standard, in

the NCI Enterprise Vocabulary Server, etc. ◦ Dissemination, education, utilization