Prof.XudongLuZhejiangUniversity,P.R.China

2016.01.22

IntroductionofZJU-BMI-RG&UsecasestudyofApplyingopenEHRarchetypestoCDRImplementation

The Biomedical Informatics ResearchGroup is established in 1996. Through20 years’ development, it covers manyareas in medical informatics, includingEHR, Data Integration, CDSS, mHealth,Medical Language Processing, ClinicalData Mining and TranslationalInformatics.

There are totally around 60 staffsincluding 2 professors, 4 associateprofessors , Ph.D/Master students &software engineers.

BiomedicalInformaticsResearchGroupinZJU

Usecasestudy:ApplyingopenEHRarchetypestoCDRImplementation

Background of the ResearchØ 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%hospitalshaveimplementedCDRinChinauntil2014CDR 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 electronicmedical recordssystem,regionalhealth information sharing.

0.04% 0

Stage6 Closed-loop management ofthewhole processofmedical data,advancedmedical decisionsupport.

0.16% 0.19%

Stage5 Unified datamanagement, dataintegrationamongdepartment systems.

0.21% 0.38%

Stage4 Information sharing inhospital, intermediatemedical decision support.

3.89% 5.61%

Stage3 Dataexchange amongdepartments, primarymedical decision support.

13.05% 15.25%

Stage2 Dataexchange withinthedepartment. 22.33% 21.78%

Stage1 Preliminary datacollected within thedepartment 11.10% 10.41%

Stage0 Not formedelectronicmedical recordssystem 49.21% 46.38%

Areal-timeunifieddatabaseofpatientclinicalinformation

Clinical Data Repository

Patient ServiceClinical Support Research

LIS CPOEPACSHMIS EIS OIS

Interoperability

Integration Engine

CIS

CDR in the hospital

8

ThecommonwayofimplementingCDR

It’s over-reliance on vendors and time-consuming and cost-consuming for any extension

Requirementsusers

BIGmodel

BIGschema

Concepts&relationships

datastore

communication

information

GUIApp

Software

OOdevtRDBMSdevt

define

ImplementedinHard-codedin

developer

Problems

Source Items

Requirements 348

ExistingCDR* 93

Diabetes-relatedDataElements

CardiacDataElementsSource Items

Requirements 257

ExistingCDR* 101

ThedataintheCDRarealwaysnotenoughtofittherequirement

*TheexistingCDRaretheoneimplementedinEMR-SinonelargehospitalinChina

Acaseformedicalexpertstoconductalong-termfollow-upstudyondiabetes

AcaseforCVDdepartmenttointroduceadecisionsupportsystem

BiotherapyrelatedDataElementsSource Items

Requirements 103

ExistingCDR* 23

Acaseformedicalexpertstoconductclinicalresearchonbiotherapy

Clinicians Engineers

Clinical Data Repository

HIS LIS PACS …RIS EIS OIS

Data Viewer

DataAnalytics

DecisionSupport 。。。

DataMining

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

TheGapbetweenrequirementandReality

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.

TheexistingartefactsofopenEHR community

There are many previous defined archetypes, templates openEHR Clinical Knowledge Manager (CKM), together

with several implementations around the world

Ø InformationModelling:Canarchetypesandtemplatesbe

useddirectlyinChina?Whatshouldbeextended?

Ø CDRImplementation:HowtoimplementaopenEHR-based

systemwhichallowtheexpertsdefine,retrieve&querydata

bythemselves?

14

UseCaseStudyApplyingopenEHR archetypestoCDRimplementation inChina.

Archetypemodeling

Starting from data schemas of existing EMR, to find whether the CDR requirements can be modelled using archetypes in CKM

AnalyzeExistingdatabaseschema

Mergingitemswithsamesemantics

Referringexisitingstandards

AbstractClinicalconcepts

FindCorrespondingarchetypein

CKM

Exist Newarchetype

ModificationCoverconcept

completely

Adoptdirectly

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

Dataschema-1 Dataschema-2 CDRrequirements

PAT_MASTER_INDEX MASTER_PATIENT_INDEX Patient demographics(69items)

MEDREC.DIAGNOSIS DIAGNOSIS Diagnosis information(25items)MEDREC.PAT_VISITOUTPADM.CLINIC_MASTERINPADM.PATS_IN_HOSPITAL

PATIENT_VISITVISIT_IN_HOSPITALVISIT_OUT_PATIENT

AdmissionDischargeTransfer (175items)

ORDADM.ORDERSOUTPDOCT.OUTP_ORDERS

ORDERSORDERS_PERFORM

Order information(92items)

ORDADM.VITAL_SIGNS_REC VITAL_SIGNS_RECORD Vital signsinformation(items)17EXAM.EXAM_MASTEREXAM.EXAM_ITEMSEXAM.EXAM_DATAEXAM.EXAM_REPORT

EXAM_REQUESTEXAM_ITEMEXAM_REPORTEXAM_DATA

Examination information(182items)

LAB.LAB_TEST_MASTERLAB.LAB_TEST_ITEMSLAB.LAB_RESULT

LAB_TEST_REQUESTLAB_TEST_DATALAB_TEST_MASTER

Lab testinformation(112items)

OPERATION_SCHEDULEOPERATION_MASTER

OPERATION_REQUESTOPERATION_REPORT

Operationinformation(200 items)

BLDBANK.BLOOD_APPLYBLDBANK.BLOOD_CAPACITY

Transfusion(36items)

NURSERECORD_SUMMARY Nursinginformation(62items)

CONSULT_MASTER Consultinformation(39items)

NEWBORM_REPORT Newborn information(129items)

EMR.EMR_DOCUMENT EMR_DOCUMENTEMR_DOCUMENT_DETAIL

EMRdocument information(88items)

Total 1226items

17

Items merging

Merge the items from the data schemas with the same semantic into 892 CDR data items.

Number of itemsCDRrequirements Dataschema-1 Dataschema-2 CDRitems

Patient demographics 26 43 31Diagnosis information 12 13 15

AdmissionDischargetransfer

119 56 123

Order information 36 56 40MedicationOrder None None 57Prescription None None 42Therapy None None 21Diet None None 22Dispose None None 22Vital signsinformation 7 10 12Examination information 109 73 63Lab testinformation 48 64 58

Operationinformation 79 121 124Transfusion 36 None 32

Nursinginformation 62 None 30Consultinformation None 39 22

Newborn information None 129 133

EMRdocument information 28 60 45

WS445-2014 CDRrequirements

1)medicalrecordsummary patientdemographics,encounters

2)outpatientandemergencymedicalrecord

imagingexamination

3)outpatientandemergencyprescription

medication

4)examinationandlaboratorytestrecord

imagingexamination,laboratorytest

5)generaltherapyandtreatmentrecord medication

6)deliveryrecordoftherapyandtreatment

Therapy

7)nursingoperationrecords Nursing8)nursingvaluationandplan none9)informinginformation none10)homepageofinpatientmedicalrecord

EMR document

11)homepageofinpatientmedicalrecordsummaryofTCM

EMR document

12)admissionrecord encounters13)inpatientprogressnote imagingexamination14)inpatientorder medication15)dischargedbrief encounters16)transferrecord encounters17)medicalinstitutioninformation Admission

EMRdocument

Standardization

Refer two standards by MOH in China in order to get the standardized representation of data items, totally 553 items.

WS363-2011 CDRrequirements

1)identification patientdemographics,encounters,medication,imagingexamination,laboratorytest

2)demographicsandsocialeconomicscharacteristics

patientdemographics

3)healthhistory EMR documents4)healthriskfactor EMR documents,operation5)chiefcomplaintandsymptom Diagnosis, EMRdocuments6)physicalexamination Operation

EMRdocumentsOrders

7)assistantexamination imagingexamination8)laboratoryexamination patientdemographics,

laboratorytest9)diagnosis encounters10)medicalassessment encounters11)medicalplanandintervention encounters,medication12)healthexpenditure Orders,13)healthcareorganization patientdemographics,

encounters,medication,imagingexamination,laboratorytest

14)healthpersonnel Nursing,Therapy15)drugandmaterial medication16)healthmanagement Nursing, EMRdocuments

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

Mappingrules

Mapping concepts to archetypes in CKM based on the mapping rules.

Result offinding Category operation

Exist correspondingarchetype

Covered byarchetypecompletely

Useddirectly

Needtomodifydescription, translation,extendthevaluesets.

Revision

Need tospecialize thearchetype, addmoreconstraint.

Specialisaztion

Need toaddnewitems inthedefinition section andkeepcompatibility.

Extension

Modification thatmakethearchetypeisincompatible withoriginalarchetype.

New version

Nocorrespondingarchetype

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

Newversion

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

Requestitem

Result

Report

DICOMStudy

Image

1

N

1 1

1

1

1

1

1

1

NN

N

N

Request

Requestitem

Result

Report

DICOMStudy

Image

1

N

1 1

1

1

1

N

N

N

Request

Requestitem

Result

Report

DICOMStudy

Image

1

N

1 1

1

1

1

1

1

1

NN

N

N

Requirements Archetypes in CKM After modification

2archetypes 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?

ØInformationModelling:Canarchetypesandtemplatesbe

useddirectlyinChina?Whatshouldbeextended?

ØCDRImplementation:HowtoimplementaopenEHR-based

systemwhichallowtheexpertsdefine,retrieve&querydata

bythemselves?

27

UseCaseStudyApplyingopenEHR archetypestoCDRimplementation inChina.

Archetype-basedCDRsystem– mainideas

Archetype/Template

Data persistence

Data application

Data manipulation

Modelofdatastoragegeneratedfromarchetype

Fullfeatureddatamanipulationlanguageonarchetype

Userinterfacegeneratedfromarchetype/TemplateStructureddataqueryandentry

Domainexpertsmanagethearchetypes

Archetype-based flow chart of CDR platform

Start

Archetypeedit

DBDeploy

APIDeploy

APPEdit APPDeploy

Database

Application

API

TemplateArchetype Templateedit

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

ArchetypeTemplate

Experts

TRM

Schema

Rules

+

L.Wang,L.Min,R.Wang,X.Lu,andH.Duan,"Archetyperelationalmapping-apracticalopenEHRpersistencesolution,"BMCmedicalinformaticsanddecisionmaking,vol.15,p.1,2015.

Data persistence

xml database

Basic serialization

XML databaseNode+path

1. Performance slower than conventional RDB2. 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

Rulesformappingtemplatetoentity

Archetype

OET

TRMConfig

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)

Query1.1 80(+74%) 46 5017

Query1.2 91(+54%) 59 5121

Query1.3 196(+15%) 170 5358

Query2.1 221(+16%) 191 24866

Query2.2 219(+17%) 187 25094

Query2.3 474(+129%) 207 26158

Query3.1 242 270(+12%) 294774

Query3.2 224 299(+33%) 297388

Query3.3 254 411(+62%) 362950

Query4.1 198(+13%) 176 127547

Query4.2 254(+32%) 193 128508

Query4.3 1249(+57%) 797 129901

Query5.1 113 186(+65%) 328181

Query5.2 125 205(+64%) 329097

Query5.3 139 239(+72%) 388727

Query6.1 14596(+5150%) 278 5746

Query6.2 16340(+5293%) 303 6029

Query6.3 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

ArchetypeTemplate

Experts

+SQL

API

Clause Key wordSELECT SELECT

FROMWHEREORDER BY

INSERT INSERTUPDATE UPDATE

SETWHERE

DELET DELET FROMWHERE

AQLData Storage

TQL Query Engine

Developer

Archetype Query Language (AQL) A complete data manipulate language, including data select, update, delete, and insert functionClause Key word ParameterSELECT SELECT Attribute identify path in archetype

FROM Archetype nameWHERE Attribute identify path in archetype operator (>,

>=, =, <, <=, !=) condition valueORDER BY Attribute identify path in archetype

INSERT INSERT INTO Archetype instances in the format of dADLVALUES Attribute identify path in archetype and assigned value

UPDATE UPDATE Archetype nameSET Attribute identify path in archetype operator (=)

condition valueWHERE Attribute identify path in archetype operator (>,

>=, =, <, <=, !=) condition valueDELET DELET Attribute identify path in archetype

FROM Archetype nameWHERE 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 OBSERVATION o [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

OBSERVATION o [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 OBSERVATION o [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

Queryserial 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

Queryserial number

Recordscount

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

Retrievingpatientinformationbypatientidentifier Retrievingimageinformationbyexamidentifier

The execution time is similar between AQL query and API query. On account of package for dADL, the AQL average performance is little slower than API.

Archetype Model

Information source

Data Storage

Medical Knowledge

Data Requirement TRM

rules

ArchetypeTemplate

Domain experts

+ UI layout

Clinician experts

Drag

DropData

bindingAttributes

edit

Data entry UI

Archetype-driven data application

archetype/templateeditor

template

archetype/templatedatabase

Applicationdatabase

Create/modify

Domainexpert

user

developer

Adjust/organize

archetype

application

Domain expert can use the GUI generator to define GUI whatever he likes

Methods for application development

archetype/templateeditor

template

archetype/templatedatabase

Applicationdatabase

create

TRM

expert

AQL

“WYSIWYG”editor Generalsoftwareframework

Dataapplicationtemplate

design

archetype

Application development with user-control approach

user

application

In order to achieve user-control application development, this study proposes archetype-driven approach using application template and general software framework.

UIController Datamodule Database

WebApplications

Generalframework

GUIinformation

Databinding

Controlinformation

Applicationtemplate

<body> <li style="position: absolute; height: 32px; width: auto; cursor: pointer; top: 187px; left: 15px;"> <img ng-class="UIData.label.picType" class="CLUSTER">

<span> <b class="ng-binding">饮酒史</b></span></li><li style="position: absolute; height: 32px; width: auto; cursor: pointer; top: 187px; left: 89px;"><select name="Flag_Alcohol drinking history" id="/items[at0005]" template="openEHR-EHR-

COMPOSITION.first_interview.v1" > <option value=""> </option>

<option value="无">无</option>

<option value="有">有</option></select></li><li style="position: absolute; height: 32px; width: auto; cursor: pointer; top: 216px; left: 40px;"> <img ng-class="UIData.label.picType" class="DV_CODED_TEXT">

<span class="ng-binding">种类:</span> <select name="Type_Alcohol drinking history" id="/items[at0001]" template=" openEHR-EHR-

COMPOSITION.first_interview.v1" style="width:80px;" >

…… </select></li><li style="width: auto; position: absolute; height: 32px; cursor: pointer; top: 216px; left: 200px;" ><img class="DV_QUANTITY">

<span class="ng-binding">饮酒量: </span>

…… <button class="btn btn-default" type="button" ng-click="save()">保存</button>

</body><script> function save( scope ){ var aql=”insert into”;

foreach (item in scope){ aql=aql+item.tempate;

……} }

</script>

Dataoperation function

controls

openEHR template

Application template

Applicationtemplatefile

The development flow

Createarchetype/template

Chooseandexpandtemplate

AddcontrolsandadjustpagecontentSavepagesLoadapplication

ChoosedataitemsandgenerateHML

• 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

40000000Data statistics

Examinationrequest Examinationdata Labtestrequest Labtestdata

Operationrequest Diagnosis Healthexamination 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 DomainexpertsdraganddroptheattributesfromthetemplatestocontroltheUI.

Ø Thecontroltypeautomaticgeneratedbasedonthearchetypetemplate,ARMandReferencemodel.

Ø ManipulatingtheDatabindingwitharchetypemodelaccordingtheclinicalpractice.

Diabetes Follow-up data management application 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?

PlansofpromotingopenEHR inChina

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