Nidhi GulatiUNC Carolina Health Informatics Program Practicum

May 24, 2013

Current Data ProblemsCurrent data standards are inadequate to support exchange and re-use

of data collected and used in clinical domains

Data may be exchanged between providers, but variations in meaning, measurement, and coding systems, etc. result in data that cannot be easily used for patient care or support secondary uses such as quality improvement and research

Terminologies (ICD and SNOMED) alone are insufficient to cope up with these challenges

This lack of semantic interoperability results in poor information quality in health care and in secondary data uses

'Standardizing clinical data elements' paper by Meredith Nahm, et al.'Knowledge Aquisition from and Semantic Variability in Schizophrenia Clinial Trial Data' paper by Meredith Nahm

Solution

Standardization of data elements to support patient care and secondary uses is strongly considered part of the solution to the problems of lack of semantic interoperability and poor information quality in healthcare

Standardization will facilitate meaningful quality exchange of health information and re-use of data

'Standardizing clinical data elements' paper by Meredith Nahm, et al.'Knowledge Aquisition from and Semantic Variability in Schizophrenia Clinial Trial Data' paper by Meredith Nahm

Why the same Standards?

Standards enable interoperability

Three aspects of interoperability:Technical: Moving data from system A to system BSemantic: Ensuring that systems A and B understand

the data in the same wayProcess: Enabling business processes at organizations

housing systems A and B to work together

http://www.hl7.org/documentcenter/public_temp_973A0F7F-1C23-BA17-0C22BE995BB25E98/training/IntroToHL7/player.html

CDISC and HL7There are two standards development organizations relevant for this work:

Clinical Data Standards Interchange Consortium (CDISC) – the data standards organization for FDA regulated research

Health Level Seven (HL7) – the data standards development organization for Healthcare

2012

Health Level Seven (HL7)

The Philosophy1) Developing data element standards with healthcare and

secondary data use stakeholders will enable standards that work for patient care AND also support secondary data uses such as research, performance measurement, quality improvement, and public health reporting

2) Supporting only one use is insufficient3) Healthcare first – data generated and used in Screening,

Diagnosis, Treatment & Management

- CDER Data Standards Webpage N

ahm

, M.,

Wal

den,

A.,

McC

ourt

, B.,

Piep

er, K

., H

oney

cutt

, E.,

Ham

ilton

, C.D

., H

arri

ngto

n, R

.A.,

D

iefe

nbac

h, J.

, Kis

ler,

B.,

Wal

ker,

M.,

Ham

mon

d, W

.E.,

Sta

ndar

dizi

ng C

linic

al D

ata

Elem

ents

. Int

erna

tiona

l Jo

urna

l of F

unct

iona

l Inf

orm

atic

s an

d Pe

rson

alis

ed M

edic

ine

(IJF

IPM

) Spe

cial

Issu

e on

: "Th

e In

form

atic

s of

M

eta-

data

, Que

stio

ns, a

nd V

alue

Set

s". V

ol. 3

, No.

4, 2

010.

More Philosophy4. Clinical professional societies are the only

authoritative source of clinical definitions5. Data element is the fundamental unit of

information exchange and use6. Data elements should be standardized (i.e., ANSI

accredited SDO)7. Standard data elements should be freely

available in searchable metadata registries

Nah

m, M

., W

alde

n, A

., M

cCou

rt, B

., Pi

eper

, K.,

Hon

eycu

tt, E

., H

amilt

on, C

.D.,

Har

ring

ton,

R.A

.,

Die

fenb

ach,

J., K

isle

r, B

., W

alke

r, M

., H

amm

ond,

W.E

., S

tand

ardi

zing

Clin

ical

Dat

a El

emen

ts.

Inte

rnat

iona

l Jou

rnal

of F

unct

iona

l Inf

orm

atic

s an

d Pe

rson

alis

ed M

edic

ine

(IJF

IPM

) Spe

cial

Issu

e on

: "T

he In

form

atic

s of

Met

a-da

ta, Q

uest

ions

, and

Val

ueSe

ts".

Vol

. 3, N

o. 4

, 201

0.

Therapeutic Area Projects Cardiology

Acute Coronary Syndromes (ACS) Cardiovascular Imaging

Tuberculosis

Anesthesia- preop. Assmt. Pre-hospital Emergency Care Diabetes (pilot) Trauma registration Schizophrenia Major Depressive Disorder ICU, Pediatric exercise testing,

TBI

Cardiology R1 May 2008 – 24 data elements R2 Jan. 2012 – 383 data elements CDISC SDTM representation

underway Tuberculosis

R1 Sept 2008 – 139 data elements CDISC SDTM representation

release for public comment summer 2012

R1 Sept 2011, R2 Jan 2013 R1 Sept 2010, CDA R2 2011 Diabetes pilot completed 2011 New project Ballot 2012, re-ballot May/Sept

2013 Ballot May/Sept 2013 New projects in discussion

Overview of Duke Data Element Standards Work Presentation, 2012

Data Element Standardization Process

1. Data element Knowledge Acquisition- Identify data elements here, Major Depressive Disorder (MDD) questionnaires

2. Data element Synthesis (not within my scope)

3. Data element Definitions- Clinical definitions from Authoritative Clinical Professional Society(ies) and form context

Knowledge Acquisition

Elements

1. Experts2. Documented knowledge of experts

Data collection formsClinical guidelinesClinical documentationData dictionaries, e.g.,

RegistriesEHR screens /

systemsProtocols

Overview of Duke Data Element Standards Work Presentation, 2012

Anatomy of a Data Element

Data element is the fundamental unit of data exchange

It is an association of a data element concept and a representation primarily of a value domain (ISO/IEC 11179)

AIM severity:

Data Element

AIM severity:

Data Element

AIM severity:

Data Element

AIM severity:Question or

prompt

Value format

Data Element

NoneMinimalMildModerateSevere

Abnormal Involuntary Movement Scale (AIMS) – Rating Scale Data Element example

Abstracted Data Elements & Definitions

The Drug Abuse Screening Test (DAST)

Abstracted Data Elements & Definitions

Total CountMDD Questionnaires # 12

MDD Data Elements # 205

MDD Definitions # 205

MDD Permissible Value list (PVL) # 813

FundingThe work presented here in:

Major Depressive Disorder (R24FD004656-01)

was made possible by funding from the Food and Drug Administration (FDA), a component of the Department of Health and Human Services (HHS).