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Prof.	Xudong	Lu
Zhejiang	University,	P.R.China
2016.01.22
Introduction	of	ZJU-BMI-RG	&
Use	case	study	of	Applying	openEHR
archetypes	to	CDR	Implementation
The Biomedical Informatics Research
Group is established in 1996. Through
20 years’ development, it covers many
areas in medical informatics, including
EHR, Data Integration, CDSS, mHealth,
Medical Language Processing, Clinical
Data Mining and Translational
Informatics.
There are totally around 60 staffs
including 2 professors, 4 associate
professors , Ph.D/Master students &
software engineers.
Biomedical	Informatics	Research
Group	in	ZJU
Use	case	study:	Applying	openEHR
archetypes	to	CDR	Implementation
Background of the Research
Ø Part of Project of “Medical Data Integration & Merging”, funded by
Chinese National “863” Program, initiated in 2012.
Ø Research Purpose: An methodology of implementing open and
extensible CDR and a case study in a pilot hospital
Shangxi Dayi Hospital with 2600 beds
What is CDR ?
Ø Definition of CDR
• A data store that holds and manages clinical data collected
from service encounters at point of service locations (e.g.
hospitals, clinics) (from ISO/TR 20514,2005)
Ø CDR has been widely developed and implemented
internationally.
• 46.7% hospitals in Asia Pacific
• 71.2% hospitals in Middle East
• 67.2% hospitals in Canada
• 94.8% hospitals have implemented CDR in America
0.57%	hospitals	have	implemented	CDR	in	China	until	2014
CDR in China
CDR is particularly important for this stage of the
development of medical information in China.
Stage Description	 2013
(N=2414)
2014
(N=2622)
Stage 7 Complete electronic	medical	records	system,	
regional	health	information	sharing.
0.04% 0
Stage	6 Closed-loop	 management of	the	whole	process	
of	medical	data,	advanced	medical	decision	
support.
0.16% 0.19%
Stage	5 Unified	data	management,	data	integration	
among	department	systems.
0.21% 0.38%
Stage	4 Information sharing	in	hospital,	intermediate	
medical	decision	 support.
3.89% 5.61%
Stage	3 Data	exchange among	departments,	 primary	
medical	decision	 support.
13.05% 15.25%
Stage	2 Data	exchange within	the	department. 22.33% 21.78%
Stage	1 Preliminary	 data	collected within	the	department 11.10% 10.41%
Stage	0 Not formed	electronic	medical	records	system 49.21% 46.38%
A	real-time	unified	database	of	patient	clinical	information
Clinical Data Repository
Patient ServiceClinical Support Research
LIS CPOEPACSHMIS EIS OIS
Interoperability
Integration Engine
CIS
CDR in the hospital
8
The	common	way	of	implementing	CDR
It’s over-reliance on vendors and time-consuming and
cost-consuming for any extension
Requirements	
users
BIG	
model
BIG	
schema
Concepts	&	relationships
data	
store
communication
information
GUI	App
Software
OO	devt
RDBMS	devt
define
Implemented	in
Hard-coded	in
developer
Problems
Source Items
Requirements 348
Existing	CDR* 93
Diabetes-related	Data	Elements
Cardiac	Data	Elements
Source Items
Requirements 257
Existing	CDR* 101
The	data	in	the	CDR	are	always	not	enough	to	fit	the	requirement
*	The	existing	CDR	are	the	one	implemented	in	EMR-S	in	one	large	hospital	in	China
A	case	for	medical	experts	to	
conduct	a	long-term	follow-
up	study	on	diabetes
A	case	for	CVD	department	
to	introduce	a	decision	
support	system
Biotherapy	related	Data	Elements
Source Items
Requirements 103
Existing	CDR* 23
A	case	for	medical	experts	to	
conduct	clinical	research	on	
biotherapy
Clinicians Engineers
Clinical Data Repository
HIS LIS PACS …RIS EIS OIS
Data
Viewer
Data
Analytics
Decision
Support
。。。
Data
Mining
Gap
I want to
query the
count of
patient with
CIK therapy
plan Researchers
I want to find
the relationship
between
diseases and
certain factors
Patients
I want to find
the number
of patients
like me
I want to
integrate my
new system to
CDR
Increasing requirement
cannot be filled
Developed software
cannot be fully used
The	Gap	between	requirement	and	Reality
The Ideal Solution
An Open Extensible Information Platform
Let the people with data requirement retrieve & query
data themselves
I can
configure a
simple form
for my
request
I can get the
necessary
data as input
to analytics
software
I can query
whatever I
needed
I can
transfer the
data to my
own
structure
Clinical Data Repository
HIS LIS PACS …RIS EIS OIS
Clinicians EngineersResearchers Patients
OpenEHR methodology ?
The openEHR method has the flexibility and scalability,
and archetypes account for them.
The	existing	artefacts		of	openEHR community
There are many previous defined archetypes, templates
openEHR Clinical Knowledge Manager (CKM), together
with several implementations around the world
Ø Information	Modelling:	Can	archetypes	and	templates	be	
used	directly	in	China?	What	should	be	extended?	
Ø CDR	Implementation:	How	to	implement	a	openEHR-based	
system	which	allow	the	experts	define,	retrieve	&	query	data	
by	themselves?
14
Use	Case	Study		
Applying	openEHR archetypes	to	CDR	implementation	in	China.
Archetype	modeling
Starting from data schemas of existing EMR, to find whether the
CDR requirements can be modelled using archetypes in CKM
Analyze	Existing	
database	
schema
Merging	items	
with	same	
semantics
Referring	
exisiting	
standards
Abstract	Clinical	
concepts
Find	
Corresponding	
archetype	in	
CKM
Exist	
New	
archetype
Modification	
Cover	
concept	
completely
Adopt	
directly
Yes
No	
Yes	
No	
1
2
3
4
5 6
6
6
Analyze data schemas
Analyze the two EMR database schema that is used in more than
200 hospitals in China to collect the basic CDR requirements
Data	schema-1	 Data	schema-2 CDR	requirements
PAT_MASTER_INDEX MASTER_PATIENT_INDEX Patient demographics	(	69items)
MEDREC.DIAGNOSIS DIAGNOSIS Diagnosis information	(25	items)
MEDREC.PAT_VISIT
OUTPADM.CLINIC_MASTER
INPADM.PATS_IN_HOSPITAL
PATIENT_VISIT
VISIT_IN_HOSPITAL
VISIT_OUT_PATIENT
Admission
Discharge	
Transfer						(175	items)
ORDADM.ORDERS
OUTPDOCT.OUTP_ORDERS
ORDERS
ORDERS_PERFORM
Order information		(92		items)
ORDADM.VITAL_SIGNS_REC VITAL_SIGNS_RECORD Vital signs	information	(	items)17
EXAM.EXAM_MASTER
EXAM.EXAM_ITEMS
EXAM.EXAM_DATA
EXAM.EXAM_REPORT
EXAM_REQUEST
EXAM_ITEM
EXAM_REPORT
EXAM_DATA
Examination information
(182items)
LAB.LAB_TEST_MASTER
LAB.LAB_TEST_ITEMS
LAB.LAB_RESULT
LAB_TEST_REQUEST
LAB_TEST_DATA
LAB_TEST_MASTER
Lab test	information	(112items)
OPERATION_SCHEDULE
OPERATION_MASTER
OPERATION_REQUEST
OPERATION_REPORT
Operation	information	(200 items)
BLDBANK.BLOOD_APPLY
BLDBANK.BLOOD_CAPACITY
Transfusion	(36	items)
NURSERECORD_SUMMARY Nursing	information	(62	items)
CONSULT_MASTER Consult	information	(39	items)
NEWBORM_REPORT Newborn information	(129items)
EMR.EMR_DOCUMENT EMR_DOCUMENT
EMR_DOCUMENT_DETAIL
EMR	document information	
(88	items)
Total 1226	items
17
Items merging
Merge the items from the data schemas with the same
semantic into 892 CDR data items.
Number of itemsCDR	requirements Data	schema-1 Data	schema-2 CDR	items
Patient demographics 26 43 31
Diagnosis information 12 13 15
Admission
Discharge	
transfer
119 56 123
Order information 36 56 40
Medication	Order None	 None	 57
Prescription None	 None 42
Therapy	 None None 21
Diet	 None None 22
Dispose None None 22
Vital signs	information 7 10 12
Examinationinformation 109 73 63
Lab test	information 48 64 58
Operation	information 79 121 124
Transfusion 36 None 32
Nursing	information 62 None 30
Consult	information None 39 22
Newborn information None 129 133
EMR	document information 28 60 45
WS	445-2014 CDR	requirements
1)	medical	record	summary patient	demographics,	
encounters
2)	outpatient	and	emergency	medical	
record
imaging	examination
3)	outpatient	and	emergency	
prescription
medication
4)	examination	and	laboratory	test	
record
imaging	examination,	
laboratory	test
5)	general	therapy	and	treatment	record medication
6)	delivery	record	of	therapy	and	
treatment
Therapy
7)	nursing	operation	records Nursing
8)	nursing	valuation	and	plan none
9)	informing	information none
10)	home	page	of	inpatient	medical	
record
EMR document
11)	home	page	of	inpatient	medical	
record	summary	of	TCM
EMR document
12)	admission	record encounters
13)	inpatient	progress	note imaging	examination
14)	inpatient	order medication
15)	discharged	brief encounters
16)	transfer	record encounters
17)	medical	institution	information Admission
EMR	document
Standardization
Refer two standards by MOH in China in order to get the
standardized representation of data items, totally 553 items.
WS	363-2011 CDR	requirements
1)	identification patient	demographics,	
encounters,	medication,	
imaging	examination,	
laboratory	test
2)	demographics	and	social	
economics	characteristics
patient	demographics	
3)	health	history EMR documents
4)	health	risk	factor EMR documents,	operation
5)	chief	complaint	and	symptom Diagnosis, EMR	documents
6)	physical	examination Operation
EMR	documents
Orders	
7)	assistant	examination imaging	examination
8)	laboratory	examination patient	demographics,	
laboratory	test
9)	diagnosis encounters
10)	medical	assessment encounters
11)	medical	plan	and	intervention encounters,	medication
12)	health	expenditure Orders,	
13)	healthcare	organization patient	demographics,	
encounters,	medication,	
imaging	examination,	
laboratory	test
14)	health	personnel Nursing,	Therapy
15)	drug	and	material medication
16)	health	management Nursing, EMR	documents
CDR requirements and WS 445-2014 CDR requirements and WS 363-2011
Concept acquisition
Guided by Information Model of openEHR, based on the clinical
practice in China, classified 62 clinical concepts
20
Mapping	rules	
Mapping concepts to archetypes in CKM based on the
mapping rules.
Result of	finding Category operation
Exist corresponding	
archetype
Covered by	archetype	
completely
Used	directly
Need	to	modify	
description, translation,	
extend	the	value	sets.
Revision	
Need to	specialize	the	
archetype,	add	more	
constraint.
Specialisaztion	
Need to	add	new	items	in	
the	definition	 section	and	
keep	compatibility.
Extension
Modification	 that	make	
the	archetype	is	
incompatible	 with	original	
archetype.
New version
No	corresponding	
archetype
New
21
Archetypes acquisition
73 archetypes have been defined.
22
Results
45 new archetypes, 15 modification , 13 existing
archetypes used directly.
New archetypes(45)Modification and extended(15) No changed(13)
Discussion 1
Revision, Specialisation and New version are included
in openEHR specification, while Extension is omitted.
Extension	
Revision
Specialisation	
New	version
MODIFICATION	
compatibility
Modify description;
Expand attributes,
range of value sets,
terminology.
Customize an
general purpose
archetype.
Modify definition
part, add new
object nodes that
no need to narrow
than the original.
official
24
Discussion 2
Mismatches exist between metadata-level modelling
and data-level modelling which happen in candidate
archetypes and the CDR requirements.
Data-level
Metadata-level
25
Discussion 3
Problems of the granularity and relationship representation.
Request
Request	
item
Result
Report
DICOM	
Study
Image
1
N
1 1
1
1
1
1
1
1
N
N
N
N
Request
Request	
item
Result
Report
DICOM	
Study
Image
1
N
1 1
1
1
1
N
N
N
Request
Request	
item
Result
Report
DICOM	
Study
Image
1
N
1 1
1
1
1
1
1
1
N
N
N
N
Requirements Archetypes in CKM After modification
2	archetypes 3 archetypes
Image examination
data relationship
Ø The methodology of openEHR could be used in China, but
extension to existing archetypes is necessary,
Ø The modelling results so far are still coarse, need to be re-
thinking, discussion with clinicians and align with CKM.
Ø Translation and a convenient editing tool are necessary if we
want clinician to be involved.
Ø The next step would be further diving into broader and deeper
area in the special biomedical domain like cardiovascular,
health management data, and omics data.
What we learned from archetyping?
ØInformation	Modelling:	Can	archetypes	and	templates	be	
used	directly	in	China?	What	should	be	extended?	
ØCDR	Implementation:	How	to	implement	a	openEHR-based	
system	which	allow	the	experts	define,	retrieve	&	query	data	
by	themselves?
27
Use	Case	Study		
Applying	openEHR archetypes	to	CDR	implementation	in	China.
Archetype-based	CDR	system	– main	ideas
Archetype
/Template
Data persistence
Data application
Data manipulation
Model	of	data	storage	generated	
from	archetype
Full	featured	data	manipulation	
language	on	archetype
User	interface	generated	from	
archetype/Template
Structured	data	query	and	entry
Domain	experts	
manage	the	
archetypes
Archetype-based flow chart of CDR platform
Start
Archetype	
edit
DB	Deploy
API	Deploy
APP	Edit APP	Deploy
Database	
Application
API
TemplateArchetype
Template	
edit
Experts
Based on the established flow, user(s) can acquire database
schema, API and application they want by data modeling, while
the CDR platform generates them automatically with archetype-
driven method.
Archetype-driven data storage
Archetype
Model
openEHR
Data
Storage
Medical
Knowledge
Data
Requirement Reference
Model
Archetype
Template
Experts
TRM
Schema
Rules
+
L.	Wang,	L.	Min,	R.	Wang,	X.	Lu,	and	H.	Duan,	"Archetype	
relational	mapping-a	practical	openEHR	persistence	
solution,"	BMC	medical	informatics	and	decision	making,	vol.	
15,	p.	1,	2015.
Data persistence
xml database
Basic serialization
XML databaseNode+path
1. Performance slower than conventional RDB
2. Not suite to answer complex query
Take into consideration that almost all the hospitals in China adopt relational database,
the relational database persistence with openEHR approach is necessary.
Hybrid serialization
TRM Data persistence
Mapping archetype model into multiple tables, meanwhile,mapping leaf nodes into
field name of relation database table.
(Instruction	)
PK
(Observation)
PK
(Evaluation)	
PK
(Composition)	
PK
Template-driven data persistence
Rules	for	mapping	
template	to	entity	
Archetype
OET
TRM
Config
Class
-status_Value
-reservedOrder_Value
-……
Class
-memberName
-memberName
-……
Template Object
Mapping
(TOM)
JPA entity object
Object Relational
Mapping
(ORM)
Template relational Mapping
(TRM) RDB
+
+
Performance evaluation
Query IV	(ms) ARM	(ms) Node+Path (ms)
Query	1.1 80	(+74%) 46 5017
Query	1.2 91	(+54%) 59 5121
Query	1.3 196	(+15%) 170 5358
Query	2.1 221	(+16%) 191 24866
Query	2.2 219	(+17%) 187 25094
Query	2.3 474	(+129%) 207 26158
Query	3.1 242 270	(+12%) 294774
Query	3.2 224 299	(+33%) 297388
Query	3.3 254 411	(+62%) 362950
Query	4.1 198	(+13%) 176 127547
Query	4.2 254	(+32%) 193 128508
Query	4.3 1249	(+57%) 797 129901
Query	5.1 113 186	(+65%) 328181
Query	5.2 125 205	(+64%) 329097
Query	5.3 139 239	(+72%) 388727
Query	6.1 14596	(+5150%) 278 5746
Query	6.2 16340	(+5293%) 303 6029
Query	6.3 16453	(+5140%) 314 6984
Ø A comparison study among
the conventional relational
database, the generated
ARM database and the Node
+ Path database.
Ø Five data-retrieving tests
(Query 1.1- Query 5.3)
Ø Two patient-searching tests
(Query 6.1 – Query 7.2)
Ø The ARM achieve
similar performance as
the conventional
relational databases.
Ø The Node + Path
database requires far
more time than the
other two databases.
Archetype-driven Data manipulation
Archetype
Model
Information source
Data
Storage
Medical
Knowledge
Data
Requirement TRM
rules
Archetype
Template
Experts
+
SQL
API
Clause Key word
SELECT SELECT
FROM
WHERE
ORDER BY
INSERT INSERT
UPDATE UPDATE
SET
WHERE
DELET DELET FROM
WHERE
AQLData
Storage
TQL
Query
Engine
Developer
Archetype Query Language (AQL)
A complete data manipulate language, including data select,
update, delete, and insert function
Clause Key word Parameter
SELECT SELECT Attribute identify path in archetype
FROM Archetype name
WHERE Attribute identify path in archetype operator (>,
>=, =, <, <=, !=) condition value
ORDER BY Attribute identify path in archetype
INSERT INSERT INTO Archetype instances in the format of dADL
VALUES Attribute identify path in archetype and assigned value
UPDATE UPDATE Archetype name
SET Attribute identify path in archetype operator (=)
condition value
WHERE Attribute identify path in archetype operator (>,
>=, =, <, <=, !=) condition value
DELET DELET Attribute identify path in archetype
FROM Archetype name
WHERE Attribute identify path in archetype operator (>,
>=, =, <, <=, !=) condition value
SELECT o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value,
o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value
FROM OBSERVATIONo [openEHR-EHR-OBSERVATION.blood_pressure.v1]
WHERE o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value >=140 OR
o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value>=90
INSERT INTO
OBSERVATIONo [openEHR-EHR-OBSERVATION.blood_pressure.v1]
VALUES o/uid/value =newUID(),
o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value=140,
o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value=90
Ø SELECT
Ø INSERT
Archetype Query Language examples
(AQL)
Ø UPDATE UPDATE OBSERVATION o [openEHR-EHR-OBSERVATION.blood_pressure.v1]
SET o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value =140
WHERE o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value >=90
Ø DELETE DELETE o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value,
o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value
FROM OBSERVATIONo [openEHR-EHR-OBSERVATION.blood_pressure.v1]
WHERE o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value >=140
OR o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value >=90
•AQL grammar
•ANTLR grammar analyzer
•Abstract grammar tree
Grammar
analysis
•Archetype
•Variable	
•Path
Legality
verification •HQL
•Multiple SQLs
Query
execution
•XML format dADL
•Gzip compression
Result
capsulation
AQL – Execution process
Performance comparison
Query
serial
number
Records
count
API(ms) AQL(ms)
1 1 5 6
2 1 9 6
3 1 5 6
4 1 5 7
5 1 5 5
6 1 5 5
7 1 5 5
8 1 6 13
9 1 6 5
10 1 5 4
Average 1 5.6 6.2
Query
serial
number
Records
count
API(ms) AQL(ms)
1 209 10 20
2 1209 21 71
3 2847 41 150
4 56 5 8
5 1221 19 72
6 1971 28 106
7 1337 24 74
8 7 5 5
9 279 15 20
10 532 15 33
Average 966.8 18.3 55.9
Retrieving	patient	information	by	patient	identifier Retrieving	image	information	by	exam	identifier
The execution time is similar between AQLquery and API query. On accountof
package for dADL, the AQL average performance is little slower than API.
Archetype
Model
Information source
Data
Storage
Medical
Knowledge
Data
Requirement TRM
rules
Archetype
Template
Domain
experts
+ UI
layout
Clinician experts
Drag
Drop
Data
binding
Attributes
edit
Data entry UI
Archetype-driven data application
archetype/
template	editor
template
archetype/
template	database
Application	
database
Create/modify
Domain	
expert
user
developer
Adjust	/	organize
archetype
application
Domain expert can use the GUI generator to define GUI whatever he likes
Methods for application development
archetype/template	editor
template
archetype/
template	database
Application	
database
create
TRM
expert
AQL
“WYSIWYG”
editor
General	software	framework
Data	application		
template
design
archetype
Application development with user-control approach
user
application
In order to achieve user-controlapplication development,this study proposes
archetype-driven approach using application template and general software
framework.
UI	Controller Data	module Database	
Web	Applications
General	framework
GUI	
information
Data	
binding
Control	
information
Application	template
<body>
<li style= "p os ition: absolute; height: 32p x; w id th: auto; cursor: pointer ; top : 1 87p x; left: 15px;">
<img ng-class= "U ID ata.label.p icTy p e" class= "CLU STER ">
<span> <b class= "ng-binding">饮酒 史</b> </span>
</li>
<li style= "pos ition : ab solu te; h eig h t: 32px; w idth: auto ; cu rsor: pointer ; top : 187 px; left: 89px;">
<select nam e= "Flag_A lcohol drinking history " id= "/item s[at0 00 5]" template= "openEH R-EH R-
CO MP OS ITI ON .fir st_interv iew.v1" >
<o ption v alue= ""> </o ption >
<o ption v alue= "无">无</option >
<o ption v alue= "有">有</option >
</select>
</li>
<li style= "pos ition : ab solu te; h eig h t: 32px; w idth: auto ; cu rsor: pointer ; top : 216 px; left: 40px;">
<img ng-class= "U ID ata .label.picType" class= "D V_CO DED _TEX T">
<span clas s= "ng-binding">种类 :</span>
<select nam e= "Type _A lcohol drinking history " id= "/item s[at0 00 1]" template= " openEH R-EH R-
CO MP OS ITI ON .fir st_interv iew.v1" style= "w id th:80px;" >
……
</select>
</li>
<li style= "w idth: auto ; p os ition : absolute; height: 32p x; cu rsor: pointer ; top : 216 px; left: 200 px;" >
<img class= "D V_Q UA N TITY ">
<span clas s= "ng-binding">饮酒 量: </sp an>
……
<button class= "b tn b tn-default " type= "b utton " ng-click = "save() ">保存 </button >
</body>
<scr ipt>
fu nction save( scope ){
var aql=”inser t into”;
fo reach (item in scope){
aql=aq l+item .tempate ;
……
} }
</scr ipt>
Data	operation	 function
controls
openEHR template
Application template
Application	
template	file
The development flow
Create	
archetype/template
Choose	and	expand	
template
Add	controls	and	
adjust	page	content
Save	pagesLoad	application
Choose	data	items	
and	generate	HML
• Archetype/
Template Editor
• Archetype –
relational
mapping
• AQL-based
Data Access
Interfaces
• Archetype
driven UI
configuration
Archetype-based CDR system – architecture
CDR Implementation in Chinese Hospital
HIS LIS PACS …RIS EMR CIS
Archetype template
repository
Data access service
Diabetes follow-up Integrated data viewClinical decision support
Research Data Query Quality Data analysis Data mining and analysis
Application based on the CDR
Plan to
implement
Have been
implemented
CDR outcome
643665
34664534
1355345
14727482
32676 528600 115371 673619 760687
9236476
0
5000000
10000000
15000000
20000000
25000000
30000000
35000000
40000000
Data statistics
Examination	request Examination	data Lab	test	request	 Lab	test	data
Operation	request Diagnosis Health	examination Patient
Encounter Order
Ø 89 archetypes,85 tables and 142 APIs.
Ø Data volume (2012.8—2015.12)
• Medical data 120G
• 673619 patients and 760687 encounters
Integrated viewer application based on CDR
Integrated viewer application allows clinicians to view the demographic,
imaging examination,laboratory test and orders based on the CDR platform
and services.
Diabetes Follow-up data management application
based on archetype
Ø Domain	experts	drag	and	
drop	the	attributes	from	
the	templates	to	control	
the	UI.
Ø The	control	type	
automatic	generated	
based	on	the	archetype	
template,	ARM	and	
Reference	 model.
Ø Manipulating	the	Data	
binding	with	archetype	
model	according	the	
clinical	practice.
Diabetes Follow-up data managementapplication can be build by the domain
experts with the archetype-driven method,including data persistence, data
access and UI.
Ø openEHR is a promising methodology to provide a open
and highly extensible solution for building CDR
Ø Although more applications is necessary for verifying the
feasibility and performance of Archetype/Template driven
approach, the use case show its feasibility.
Ø To fully use the advantages of openEHR still need the
support from the communities.
What we learned from implementation?
Plans	of	promoting	openEHR in	China
Ø Not too many groups are working with openEHR, while HL7
things are very popular.
Ø The information interoperability is not good among different
institutions and even among different systems in one
institution. HL7 don’t solve the problem as well as they
promised to.
Ø BIG DATA and data sharing become more and more
important, it’s just the time for promoting openEHR! But the
engagement of clinicians and vendors is still a problem
The situation of openEHR in China now
Ø Open Speech to introduce openEHR concepts in forum of CMEF’16
in April 17-20
Ø Initiate the openEHR Chapter under China Association of Medical
Devices Industry Medical Software?
Planned activities to promote openEHR
--make more people know openEHR
Ø Use openEHR methodology in national projects
Ø Enhancing the CDR use case in Shangxi Dayi Hospital.
Ø Possible linkage to Regional Healthcare Data Center in Ningxia
Province
Ø Working closely with openEHR community and learn
from successful localization samples like Japan.
Planned activities to promote openEHR
--create successful stories of using openEHR
Thanks for attention!
Welcome to MEDINFO 2017 –
XIAMEN,CHINA
August 21 -25, 2017

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Introduction of BJU-BMR-RG and use case study of Applying openEHR archetypes to CDR implementation

  • 2. The Biomedical Informatics Research Group is established in 1996. Through 20 years’ development, it covers many areas in medical informatics, including EHR, Data Integration, CDSS, mHealth, Medical Language Processing, Clinical Data Mining and Translational Informatics. There are totally around 60 staffs including 2 professors, 4 associate professors , Ph.D/Master students & software engineers. Biomedical Informatics Research Group in ZJU
  • 4. Background of the Research Ø Part of Project of “Medical Data Integration & Merging”, funded by Chinese National “863” Program, initiated in 2012. Ø Research Purpose: An methodology of implementing open and extensible CDR and a case study in a pilot hospital Shangxi Dayi Hospital with 2600 beds
  • 5. What is CDR ? Ø Definition of CDR • A data store that holds and manages clinical data collected from service encounters at point of service locations (e.g. hospitals, clinics) (from ISO/TR 20514,2005) Ø CDR has been widely developed and implemented internationally. • 46.7% hospitals in Asia Pacific • 71.2% hospitals in Middle East • 67.2% hospitals in Canada • 94.8% hospitals have implemented CDR in America
  • 6. 0.57% hospitals have implemented CDR in China until 2014 CDR in China CDR is particularly important for this stage of the development of medical information in China. Stage Description 2013 (N=2414) 2014 (N=2622) Stage 7 Complete electronic medical records system, regional health information sharing. 0.04% 0 Stage 6 Closed-loop management of the whole process of medical data, advanced medical decision support. 0.16% 0.19% Stage 5 Unified data management, data integration among department systems. 0.21% 0.38% Stage 4 Information sharing in hospital, intermediate medical decision support. 3.89% 5.61% Stage 3 Data exchange among departments, primary medical decision support. 13.05% 15.25% Stage 2 Data exchange within the department. 22.33% 21.78% Stage 1 Preliminary data collected within the department 11.10% 10.41% Stage 0 Not formed electronic medical records system 49.21% 46.38%
  • 7. A real-time unified database of patient clinical information Clinical Data Repository Patient ServiceClinical Support Research LIS CPOEPACSHMIS EIS OIS Interoperability Integration Engine CIS CDR in the hospital
  • 8. 8 The common way of implementing CDR It’s over-reliance on vendors and time-consuming and cost-consuming for any extension Requirements users BIG model BIG schema Concepts & relationships data store communication information GUI App Software OO devt RDBMS devt define Implemented in Hard-coded in developer
  • 9. Problems Source Items Requirements 348 Existing CDR* 93 Diabetes-related Data Elements Cardiac Data Elements Source Items Requirements 257 Existing CDR* 101 The data in the CDR are always not enough to fit the requirement * The existing CDR are the one implemented in EMR-S in one large hospital in China A case for medical experts to conduct a long-term follow- up study on diabetes A case for CVD department to introduce a decision support system Biotherapy related Data Elements Source Items Requirements 103 Existing CDR* 23 A case for medical experts to conduct clinical research on biotherapy
  • 10. Clinicians Engineers Clinical Data Repository HIS LIS PACS …RIS EIS OIS Data Viewer Data Analytics Decision Support 。。。 Data Mining Gap I want to query the count of patient with CIK therapy plan Researchers I want to find the relationship between diseases and certain factors Patients I want to find the number of patients like me I want to integrate my new system to CDR Increasing requirement cannot be filled Developed software cannot be fully used The Gap between requirement and Reality
  • 11. The Ideal Solution An Open Extensible Information Platform Let the people with data requirement retrieve & query data themselves I can configure a simple form for my request I can get the necessary data as input to analytics software I can query whatever I needed I can transfer the data to my own structure Clinical Data Repository HIS LIS PACS …RIS EIS OIS Clinicians EngineersResearchers Patients
  • 12. OpenEHR methodology ? The openEHR method has the flexibility and scalability, and archetypes account for them.
  • 13. The existing artefacts of openEHR community There are many previous defined archetypes, templates openEHR Clinical Knowledge Manager (CKM), together with several implementations around the world
  • 15. Archetype modeling Starting from data schemas of existing EMR, to find whether the CDR requirements can be modelled using archetypes in CKM Analyze Existing database schema Merging items with same semantics Referring exisiting standards Abstract Clinical concepts Find Corresponding archetype in CKM Exist New archetype Modification Cover concept completely Adopt directly Yes No Yes No 1 2 3 4 5 6 6 6
  • 16. Analyze data schemas Analyze the two EMR database schema that is used in more than 200 hospitals in China to collect the basic CDR requirements Data schema-1 Data schema-2 CDR requirements PAT_MASTER_INDEX MASTER_PATIENT_INDEX Patient demographics ( 69items) MEDREC.DIAGNOSIS DIAGNOSIS Diagnosis information (25 items) MEDREC.PAT_VISIT OUTPADM.CLINIC_MASTER INPADM.PATS_IN_HOSPITAL PATIENT_VISIT VISIT_IN_HOSPITAL VISIT_OUT_PATIENT Admission Discharge Transfer (175 items) ORDADM.ORDERS OUTPDOCT.OUTP_ORDERS ORDERS ORDERS_PERFORM Order information (92 items) ORDADM.VITAL_SIGNS_REC VITAL_SIGNS_RECORD Vital signs information ( items)17 EXAM.EXAM_MASTER EXAM.EXAM_ITEMS EXAM.EXAM_DATA EXAM.EXAM_REPORT EXAM_REQUEST EXAM_ITEM EXAM_REPORT EXAM_DATA Examination information (182items) LAB.LAB_TEST_MASTER LAB.LAB_TEST_ITEMS LAB.LAB_RESULT LAB_TEST_REQUEST LAB_TEST_DATA LAB_TEST_MASTER Lab test information (112items) OPERATION_SCHEDULE OPERATION_MASTER OPERATION_REQUEST OPERATION_REPORT Operation information (200 items) BLDBANK.BLOOD_APPLY BLDBANK.BLOOD_CAPACITY Transfusion (36 items) NURSERECORD_SUMMARY Nursing information (62 items) CONSULT_MASTER Consult information (39 items) NEWBORM_REPORT Newborn information (129items) EMR.EMR_DOCUMENT EMR_DOCUMENT EMR_DOCUMENT_DETAIL EMR document information (88 items) Total 1226 items
  • 17. 17 Items merging Merge the items from the data schemas with the same semantic into 892 CDR data items. Number of itemsCDR requirements Data schema-1 Data schema-2 CDR items Patient demographics 26 43 31 Diagnosis information 12 13 15 Admission Discharge transfer 119 56 123 Order information 36 56 40 Medication Order None None 57 Prescription None None 42 Therapy None None 21 Diet None None 22 Dispose None None 22 Vital signs information 7 10 12 Examinationinformation 109 73 63 Lab test information 48 64 58 Operation information 79 121 124 Transfusion 36 None 32 Nursing information 62 None 30 Consult information None 39 22 Newborn information None 129 133 EMR document information 28 60 45
  • 18. WS 445-2014 CDR requirements 1) medical record summary patient demographics, encounters 2) outpatient and emergency medical record imaging examination 3) outpatient and emergency prescription medication 4) examination and laboratory test record imaging examination, laboratory test 5) general therapy and treatment record medication 6) delivery record of therapy and treatment Therapy 7) nursing operation records Nursing 8) nursing valuation and plan none 9) informing information none 10) home page of inpatient medical record EMR document 11) home page of inpatient medical record summary of TCM EMR document 12) admission record encounters 13) inpatient progress note imaging examination 14) inpatient order medication 15) discharged brief encounters 16) transfer record encounters 17) medical institution information Admission EMR document Standardization Refer two standards by MOH in China in order to get the standardized representation of data items, totally 553 items. WS 363-2011 CDR requirements 1) identification patient demographics, encounters, medication, imaging examination, laboratory test 2) demographics and social economics characteristics patient demographics 3) health history EMR documents 4) health risk factor EMR documents, operation 5) chief complaint and symptom Diagnosis, EMR documents 6) physical examination Operation EMR documents Orders 7) assistant examination imaging examination 8) laboratory examination patient demographics, laboratory test 9) diagnosis encounters 10) medical assessment encounters 11) medical plan and intervention encounters, medication 12) health expenditure Orders, 13) healthcare organization patient demographics, encounters, medication, imaging examination, laboratory test 14) health personnel Nursing, Therapy 15) drug and material medication 16) health management Nursing, EMR documents CDR requirements and WS 445-2014 CDR requirements and WS 363-2011
  • 19. Concept acquisition Guided by Information Model of openEHR, based on the clinical practice in China, classified 62 clinical concepts
  • 20. 20 Mapping rules Mapping concepts to archetypes in CKM based on the mapping rules. Result of finding Category operation Exist corresponding archetype Covered by archetype completely Used directly Need to modify description, translation, extend the value sets. Revision Need to specialize the archetype, add more constraint. Specialisaztion Need to add new items in the definition section and keep compatibility. Extension Modification that make the archetype is incompatible with original archetype. New version No corresponding archetype New
  • 22. 22 Results 45 new archetypes, 15 modification , 13 existing archetypes used directly. New archetypes(45)Modification and extended(15) No changed(13)
  • 23. Discussion 1 Revision, Specialisation and New version are included in openEHR specification, while Extension is omitted. Extension Revision Specialisation New version MODIFICATION compatibility Modify description; Expand attributes, range of value sets, terminology. Customize an general purpose archetype. Modify definition part, add new object nodes that no need to narrow than the original. official
  • 24. 24 Discussion 2 Mismatches exist between metadata-level modelling and data-level modelling which happen in candidate archetypes and the CDR requirements. Data-level Metadata-level
  • 25. 25 Discussion 3 Problems of the granularity and relationship representation. Request Request item Result Report DICOM Study Image 1 N 1 1 1 1 1 1 1 1 N N N N Request Request item Result Report DICOM Study Image 1 N 1 1 1 1 1 N N N Request Request item Result Report DICOM Study Image 1 N 1 1 1 1 1 1 1 1 N N N N Requirements Archetypes in CKM After modification 2 archetypes 3 archetypes Image examination data relationship
  • 26. Ø The methodology of openEHR could be used in China, but extension to existing archetypes is necessary, Ø The modelling results so far are still coarse, need to be re- thinking, discussion with clinicians and align with CKM. Ø Translation and a convenient editing tool are necessary if we want clinician to be involved. Ø The next step would be further diving into broader and deeper area in the special biomedical domain like cardiovascular, health management data, and omics data. What we learned from archetyping?
  • 28. Archetype-based CDR system – main ideas Archetype /Template Data persistence Data application Data manipulation Model of data storage generated from archetype Full featured data manipulation language on archetype User interface generated from archetype/Template Structured data query and entry Domain experts manage the archetypes
  • 29. Archetype-based flow chart of CDR platform Start Archetype edit DB Deploy API Deploy APP Edit APP Deploy Database Application API TemplateArchetype Template edit Experts Based on the established flow, user(s) can acquire database schema, API and application they want by data modeling, while the CDR platform generates them automatically with archetype- driven method.
  • 30. Archetype-driven data storage Archetype Model openEHR Data Storage Medical Knowledge Data Requirement Reference Model Archetype Template Experts TRM Schema Rules + L. Wang, L. Min, R. Wang, X. Lu, and H. Duan, "Archetype relational mapping-a practical openEHR persistence solution," BMC medical informatics and decision making, vol. 15, p. 1, 2015.
  • 31. Data persistence xml database Basic serialization XML databaseNode+path 1. Performance slower than conventional RDB 2. Not suite to answer complex query Take into consideration that almost all the hospitals in China adopt relational database, the relational database persistence with openEHR approach is necessary. Hybrid serialization
  • 32. TRM Data persistence Mapping archetype model into multiple tables, meanwhile,mapping leaf nodes into field name of relation database table. (Instruction ) PK (Observation) PK (Evaluation) PK (Composition) PK
  • 33. Template-driven data persistence Rules for mapping template to entity Archetype OET TRM Config Class -status_Value -reservedOrder_Value -…… Class -memberName -memberName -…… Template Object Mapping (TOM) JPA entity object Object Relational Mapping (ORM) Template relational Mapping (TRM) RDB + +
  • 34. Performance evaluation Query IV (ms) ARM (ms) Node+Path (ms) Query 1.1 80 (+74%) 46 5017 Query 1.2 91 (+54%) 59 5121 Query 1.3 196 (+15%) 170 5358 Query 2.1 221 (+16%) 191 24866 Query 2.2 219 (+17%) 187 25094 Query 2.3 474 (+129%) 207 26158 Query 3.1 242 270 (+12%) 294774 Query 3.2 224 299 (+33%) 297388 Query 3.3 254 411 (+62%) 362950 Query 4.1 198 (+13%) 176 127547 Query 4.2 254 (+32%) 193 128508 Query 4.3 1249 (+57%) 797 129901 Query 5.1 113 186 (+65%) 328181 Query 5.2 125 205 (+64%) 329097 Query 5.3 139 239 (+72%) 388727 Query 6.1 14596 (+5150%) 278 5746 Query 6.2 16340 (+5293%) 303 6029 Query 6.3 16453 (+5140%) 314 6984 Ø A comparison study among the conventional relational database, the generated ARM database and the Node + Path database. Ø Five data-retrieving tests (Query 1.1- Query 5.3) Ø Two patient-searching tests (Query 6.1 – Query 7.2) Ø The ARM achieve similar performance as the conventional relational databases. Ø The Node + Path database requires far more time than the other two databases.
  • 35. Archetype-driven Data manipulation Archetype Model Information source Data Storage Medical Knowledge Data Requirement TRM rules Archetype Template Experts + SQL API Clause Key word SELECT SELECT FROM WHERE ORDER BY INSERT INSERT UPDATE UPDATE SET WHERE DELET DELET FROM WHERE AQLData Storage TQL Query Engine Developer
  • 36. Archetype Query Language (AQL) A complete data manipulate language, including data select, update, delete, and insert function Clause Key word Parameter SELECT SELECT Attribute identify path in archetype FROM Archetype name WHERE Attribute identify path in archetype operator (>, >=, =, <, <=, !=) condition value ORDER BY Attribute identify path in archetype INSERT INSERT INTO Archetype instances in the format of dADL VALUES Attribute identify path in archetype and assigned value UPDATE UPDATE Archetype name SET Attribute identify path in archetype operator (=) condition value WHERE Attribute identify path in archetype operator (>, >=, =, <, <=, !=) condition value DELET DELET Attribute identify path in archetype FROM Archetype name WHERE Attribute identify path in archetype operator (>, >=, =, <, <=, !=) condition value
  • 37. SELECT o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value, o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value FROM OBSERVATIONo [openEHR-EHR-OBSERVATION.blood_pressure.v1] WHERE o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value >=140 OR o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value>=90 INSERT INTO OBSERVATIONo [openEHR-EHR-OBSERVATION.blood_pressure.v1] VALUES o/uid/value =newUID(), o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value=140, o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value=90 Ø SELECT Ø INSERT Archetype Query Language examples (AQL) Ø UPDATE UPDATE OBSERVATION o [openEHR-EHR-OBSERVATION.blood_pressure.v1] SET o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value =140 WHERE o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value >=90 Ø DELETE DELETE o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value, o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value FROM OBSERVATIONo [openEHR-EHR-OBSERVATION.blood_pressure.v1] WHERE o/data[at0001]/events[at0006]/data[at0003]/items[at0004]/value >=140 OR o/data[at0001]/events[at0006]/data[at0003]/items[at0005]/value >=90
  • 38. •AQL grammar •ANTLR grammar analyzer •Abstract grammar tree Grammar analysis •Archetype •Variable •Path Legality verification •HQL •Multiple SQLs Query execution •XML format dADL •Gzip compression Result capsulation AQL – Execution process
  • 39. Performance comparison Query serial number Records count API(ms) AQL(ms) 1 1 5 6 2 1 9 6 3 1 5 6 4 1 5 7 5 1 5 5 6 1 5 5 7 1 5 5 8 1 6 13 9 1 6 5 10 1 5 4 Average 1 5.6 6.2 Query serial number Records count API(ms) AQL(ms) 1 209 10 20 2 1209 21 71 3 2847 41 150 4 56 5 8 5 1221 19 72 6 1971 28 106 7 1337 24 74 8 7 5 5 9 279 15 20 10 532 15 33 Average 966.8 18.3 55.9 Retrieving patient information by patient identifier Retrieving image information by exam identifier The execution time is similar between AQLquery and API query. On accountof package for dADL, the AQL average performance is little slower than API.
  • 40. Archetype Model Information source Data Storage Medical Knowledge Data Requirement TRM rules Archetype Template Domain experts + UI layout Clinician experts Drag Drop Data binding Attributes edit Data entry UI Archetype-driven data application
  • 42. archetype/template editor template archetype/ template database Application database create TRM expert AQL “WYSIWYG” editor General software framework Data application template design archetype Application development with user-control approach user application In order to achieve user-controlapplication development,this study proposes archetype-driven approach using application template and general software framework.
  • 43. UI Controller Data module Database Web Applications General framework GUI information Data binding Control information Application template <body> <li style= "p os ition: absolute; height: 32p x; w id th: auto; cursor: pointer ; top : 1 87p x; left: 15px;"> <img ng-class= "U ID ata.label.p icTy p e" class= "CLU STER "> <span> <b class= "ng-binding">饮酒 史</b> </span> </li> <li style= "pos ition : ab solu te; h eig h t: 32px; w idth: auto ; cu rsor: pointer ; top : 187 px; left: 89px;"> <select nam e= "Flag_A lcohol drinking history " id= "/item s[at0 00 5]" template= "openEH R-EH R- CO MP OS ITI ON .fir st_interv iew.v1" > <o ption v alue= ""> </o ption > <o ption v alue= "无">无</option > <o ption v alue= "有">有</option > </select> </li> <li style= "pos ition : ab solu te; h eig h t: 32px; w idth: auto ; cu rsor: pointer ; top : 216 px; left: 40px;"> <img ng-class= "U ID ata .label.picType" class= "D V_CO DED _TEX T"> <span clas s= "ng-binding">种类 :</span> <select nam e= "Type _A lcohol drinking history " id= "/item s[at0 00 1]" template= " openEH R-EH R- CO MP OS ITI ON .fir st_interv iew.v1" style= "w id th:80px;" > …… </select> </li> <li style= "w idth: auto ; p os ition : absolute; height: 32p x; cu rsor: pointer ; top : 216 px; left: 200 px;" > <img class= "D V_Q UA N TITY "> <span clas s= "ng-binding">饮酒 量: </sp an> …… <button class= "b tn b tn-default " type= "b utton " ng-click = "save() ">保存 </button > </body> <scr ipt> fu nction save( scope ){ var aql=”inser t into”; fo reach (item in scope){ aql=aq l+item .tempate ; …… } } </scr ipt> Data operation function controls openEHR template Application template Application template file
  • 45. • Archetype/ Template Editor • Archetype – relational mapping • AQL-based Data Access Interfaces • Archetype driven UI configuration Archetype-based CDR system – architecture
  • 46. CDR Implementation in Chinese Hospital HIS LIS PACS …RIS EMR CIS Archetype template repository Data access service Diabetes follow-up Integrated data viewClinical decision support Research Data Query Quality Data analysis Data mining and analysis Application based on the CDR Plan to implement Have been implemented
  • 47. CDR outcome 643665 34664534 1355345 14727482 32676 528600 115371 673619 760687 9236476 0 5000000 10000000 15000000 20000000 25000000 30000000 35000000 40000000 Data statistics Examination request Examination data Lab test request Lab test data Operation request Diagnosis Health examination Patient Encounter Order Ø 89 archetypes,85 tables and 142 APIs. Ø Data volume (2012.8—2015.12) • Medical data 120G • 673619 patients and 760687 encounters
  • 48. Integrated viewer application based on CDR Integrated viewer application allows clinicians to view the demographic, imaging examination,laboratory test and orders based on the CDR platform and services.
  • 49. Diabetes Follow-up data management application based on archetype Ø Domain experts drag and drop the attributes from the templates to control the UI. Ø The control type automatic generated based on the archetype template, ARM and Reference model. Ø Manipulating the Data binding with archetype model according the clinical practice. Diabetes Follow-up data managementapplication can be build by the domain experts with the archetype-driven method,including data persistence, data access and UI.
  • 50. Ø openEHR is a promising methodology to provide a open and highly extensible solution for building CDR Ø Although more applications is necessary for verifying the feasibility and performance of Archetype/Template driven approach, the use case show its feasibility. Ø To fully use the advantages of openEHR still need the support from the communities. What we learned from implementation?
  • 52. Ø Not too many groups are working with openEHR, while HL7 things are very popular. Ø The information interoperability is not good among different institutions and even among different systems in one institution. HL7 don’t solve the problem as well as they promised to. Ø BIG DATA and data sharing become more and more important, it’s just the time for promoting openEHR! But the engagement of clinicians and vendors is still a problem The situation of openEHR in China now
  • 53. Ø Open Speech to introduce openEHR concepts in forum of CMEF’16 in April 17-20 Ø Initiate the openEHR Chapter under China Association of Medical Devices Industry Medical Software? Planned activities to promote openEHR --make more people know openEHR
  • 54. Ø Use openEHR methodology in national projects Ø Enhancing the CDR use case in Shangxi Dayi Hospital. Ø Possible linkage to Regional Healthcare Data Center in Ningxia Province Ø Working closely with openEHR community and learn from successful localization samples like Japan. Planned activities to promote openEHR --create successful stories of using openEHR
  • 55. Thanks for attention! Welcome to MEDINFO 2017 – XIAMEN,CHINA August 21 -25, 2017