an implementation of clinical data repository with openehr ... · the archetypes in ckm can satisfy...

Xudong Lu, Huilong Duan and Ning Deng

Zhejiang University, China

An Implementation of Clinical Data Repository with openEHR Approach

From Data Modelling to Architecture

Melbourne, 25-27 July 2016

Clinical Data Repository (CDR)

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)

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

Infrastructure Design for Hospital CDR

5

The common way of implementing CDR

It’s over-reliance on developers, 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 inHard-coded in

developer

Clinicians Engineers


HIS LIS PACS …RIS EIS OIS

Data Viewer

DataAnalytics

DecisionSupport

。。。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 are always not enough

The Gap between the bursting data requirements and the services CDR can provide

The Ideal Solution

An Easy-to-use Extensible Data Access Interfaces

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


HIS LIS PACS …RIS EIS OIS

Clinicians EngineersResearchers Patients

Allow people with requirements Q & R data themselves

OpenEHR methodology ?

The openEHR multi-layer model ensures the flexibility and

scalability of CDR and fits the increasing environment demand

Ecosystem of using openEHR-based CDR

CKM

CDR-A

Templates

Sharable

Localized

Archetypes

CDR-B

Templates

CDR-C

Templates

A

P

I

DomainExperts

Building the sharable archetypes

End Users

Defining the templates and building the applications

Developers

Building the enabling systems

International Library of

information Models

A

P

I

A

P

I

Information Modelling: Can archetypes in CKM be used

directly in China? What should be extended?

System Implementation: How to implement an openEHR-

based CDR system which allow the experts and users define,

retrieve & query data by themselves?

Data Meaningful Usage: Can the data stored in this way

satisfy the requirements from different role of people?

10

Key Issues of OpenEHR-based CDR

The existing artefacts of openEHR community

There are many previous defined archetypes, templates

in openEHR Clinical Knowledge Manager (CKM)

Totally 425

Archetypes

contributed

and shared

from 87

countries

Could archetypes in CKM be used for the presentation of hospital data in China?

…

…

Radio-logy

Existing data in Chinese hospital

Ultra-sound

Order

ECG/EEGPatha-logy

Lab Results Body Examinations

Archetypes from CKM

TissueSample

Opera-tion

Endo-scope

Standard & Uniform Representation

?

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 hospitals

in China to collect the basic CDR requirements

Data schema-1 Data schema-2 CDR requirementsPAT_MASTER_INDEX MASTER_PATIENT_INDEX Patient demographics ( 69items)

MEDREC.DIAGNOSIS DIAGNOSIS Diagnosis information (25 items)

MEDREC.PAT_VISITOUTPADM.CLINIC_MASTERINPADM.PATS_IN_HOSPITAL

PATIENT_VISITVISIT_IN_HOSPITALVISIT_OUT_PATIENT

AdmissionDischarge Transfer (175 items)

ORDADM.ORDERSOUTPDOCT.OUTP_ORDERS

ORDERSORDERS_PERFORM

Order information (92 items)

ORDADM.VITAL_SIGNS_REC VITAL_SIGNS_RECORD Vital signs information ( items)17

EXAM.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 test information (112items)

OPERATION_SCHEDULEOPERATION_MASTER

OPERATION_REQUESTOPERATION_REPORT

Operation information (200 items)

BLDBANK.BLOOD_APPLYBLDBANK.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_DOCUMENTEMR_DOCUMENT_DETAIL

EMR document information (88 items)

Total 1226 items

15

Items merging

Merge the items from the data schemas with the same

semantic into 554 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

AdmissionDischarge 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

Examination information 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 AdmissionEMR document

Standardization

Refer two standards by MOH in China in order to get the

standardized representation of data items, totally 733 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 documents4) health risk factor EMR documents, operation5) chief complaint and symptom Diagnosis, EMR documents6) physical examination Operation

EMR documentsOrders

7) assistant examination imaging examination8) laboratory examination patient demographics,

laboratory test9) diagnosis encounters10) medical assessment encounters11) medical plan and intervention encounters, medication12) health expenditure Orders, 13) healthcare organization patient demographics,

encounters, medication, imaging examination, laboratory test

14) health personnel Nursing, Therapy15) drug and material medication16) health management Nursing, EMR documents

CDR requirements and WS 445-2014 CDR requirements and WS 363-2011

Concept acquisition

Guided by the knowledge from clinicians, based on the clinical

practice in China, classified 44 clinical concepts

18

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.

Specialisation

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

19

Archetypes acquisition

71 archetypes have been defined.

20

ResultAdopt directly Modification New

CLUSTER.timing DEMOGRAPHIC-PERSON.person-patient CLUSTER.insurance

CLUSTER.medication_admin DEMOGRAPHIC-ITEM_TREE.person_details CLUSTER.contacts

CLUSTER.medication_ingredients ACTION.imaging_exam

CLUSTER.address ACTION.Lab_test

CLUSTER.distribution ACTION.medication INSTRUCTION.operation_arrangement

CLUSTER.electronic_communication ACTION.transfusion INSTRUCTION.order_excute

CLUSTER.organization ADMIN_ENTRY.admission

CLUSTER.specimen ADMIN_ENTRY.discharge_admin_info

DEMOGRAPHIC-PERSON.person.v1 EVALUATION.problem_diagnosis ADMIN_ENTRY.transaction

DEMOGRAPHIC-PARTY_IDENTITY.person_name INSTRUCTION.medication_order

DEMOGRAPHIC-ORGANISATION.organization INSTRUCTION.request-imaging_exam ACTION.emr_first_page

DEMOGRAPHIC-CLUSTER.provider_identifier INSTRUCTION.request-lab_test ACTION.order

DEMOGRAPHIC-CLUSTER.person_identifier INSTRUCTION.request-operation ACTION.Operation

INSTRUCTION.request INSTRUCTION.transfusion ACTION.order_excute

OBSERVATION.lab_test OBSERVATION.operation_record

CLUSTER.document_entry_metadata OBSERVATION.imaging_exam_report

COMPOSITION.pregnancy_summary OBSERVATION.lab_test_single OBSERVATION.emr_first_page

COMPOSITION.progress_note EVALUATION.pregnancy_summary OBSERVATION.follow_up_visit

CLUSTER.person_name OBSERVATION.apgar OBSERVATION.imaging_exam_image_series

COMPOSITION.family_history OBSERVATION.progress_note OBSERVATION.physical_sign

EVALUATION.family_history OBSERVATION.blood_match

EVALUATION.exclusion-family_history EVALUATION.immunisation_summary

EVALUATION.absence CLUSTER.employment.

EVALUATION.health_risk EVALUATION.vaccination_summary

EVALUATION.social_summary OBSERVATION.body_temperature

CLUSTER.education. INSTRUCTION.request-order

CLUSTER.household

OBSERVATION.body_surface_area.

OBSERVATION.body_mass_index

OBSERVATION.body_weight

OBSERVATION.height

14 new archetypes, 57 existing archetypes used

directly or with simple modification.

The archetypes in CKM can satisfy most of the basic

data requirements in the hospital, but so far it focuses on

the result data, other than the process data.

The next step would be further diving into broader and

deeper area in the biomedical domain. Up to now, we

have localized totally 153 archetypes from CKM

Conclusions of archetype modelling



System Implementation: How to implement a openEHR-





22


TemplatesFor CDR

ModellingAPI

Configura－tion

Data Storage

Domain experts –archetypes

IT manager in hospital –templates

A/T to RelationalDatabase Mapping

API Configured from archetype/Template

openEHR-based CDR system – design concepts

ApplicationUI Creation

UI generated from archetype/Template

1. Modeling: Using sharable archetypes to build CDR templates

2. Mapping Relational Tables based on templates

Archetype

Model

openEHR

Data

Storage

Medical

Knowledge

Data

Requirement Reference

Model

Archetype

Template

Clinician

Researcher

ARM

Schema

Rules

+

3. APIs semi-auto configured easily by engineers

4. Application UI semi-auto created by users

Data Items

UI Controls



System Implementation: How to implement a openEHR-





28


Use Case: Data Requirement from the Experts

Requirements from experts in Metabolic Syndrome Domain

Step 1: Modeling according to the requirements

Using 56 archetypes to cover all the requirements

(including 5 new archetypes)

糖尿病史原型

辅助检查原型

脂代谢紊乱原型

Step 2: UI Creating for the Application

Configure the UI based on archetypes with experts

Step 3: Deploy the system

Auto-create the Web pages for end-users

openEHR is a promising methodology to provide a highly

extensible and interoperable solution for building CDR

The methodology of openEHR could be used in China,

but extension to existing archetypes is necessary,

More applications is necessary for verifying the feasibility

and performance of the CDR implementation.

Conclusions

Thanks for your

attention!

an implementation of clinical data repository with openehr ... · the archetypes in ckm can satisfy...

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