Detailed Clinical Model project

return to: Patient Care

further to: Detailed Clinical Models

further to: Detailed Clinical Model instance construction

further to: Detailed Clinical Model guidelines for creation

further to: DAM vs DCM vs SAEAF

further to: Governance

Introduction

The DCM series of projects are as such a follow up of the DCM meeting in Boca Raton, led by Craig Parker and the DCM Brisbane workshop in 2007 with CEN, ISO, HL7, OpenEHR and clinical involvement where the recommendations were to work on harmonization of granular and detailed clinical content and where four action areas included clinician involvement, quality of detailed clinical models, representation formalisms and establishing and maintaining repositories. This is because different communities where working in splendid isolation on the same specifications of blood pressure, pulse, breathing, Apgar score, Glasgow Coma Scale, Health and Physical, assessments and so on.

Project Intent

• To create and maintain in a repository a set of detailed clinical models that can be transformed from a generic model into EHR profile, HL7 templates, V3 Clinical Statements (for use in O&O, CDA, PC R-MIMs), and that can function in ISO 13606 and OpenEHR series of standards.
• To build further on past and existing efforts on archetype development from OpenEHR and CEN 13606, template, Clinical Statement and R-MIM development in HL7, and clinical domain expressions in different associations.
• To organize clinical content in such a manner that it becomes multi useable in different standards and different technologies, thus supporting both the Joint work and semantic interoperability. The repository will be one practical outcome of the joint initiative.

Project Scope

The overall goals of the DCM initiative are:

• to develop methods, tools for requirements gathering with clinicians, requirements for modelling tools,
• to enforce quality control, authorisation and governance of DCM rules,
• to identify clinical items, binding of clinical content to terminology,
• to model generically and make transforms to different formalisms,

and

• to maintain in a repository a set of DCM that are useable in different standards, formats and different technical implementations using the same generic model. The purpose is to enhance the semantic interoperability between different systems and developments.

Based on discussions in ISO Joint Working Group 9, the JWG leadership requested two projects to be started:

1. A set of examples, useful in a standard.

2. A set of criteria for good quality of DCM that are indeed clinically sound and implementable in different technical environments.

We have created a Top 10 list of DCMs and discussed its use in HL7 project 320 on DCM, where this document is an update of. Establishing DCM criteria and methodologies is currently done under ISO NIWP 13972, which was approved on July 2009.

This proposal includes the proper representation of assessment scales, indexes and scoring systems. It will use elements of other HL7 WGs or projects such as Terminfo, Structured Documents, Templates and Clinical Statement. A DCM includes the purpose of one or small set of clinical data elements, the evidence base, data element specification, proper procedure, interpretation of values, and literature references. A guideline for this has been created on behalf of Nictiz in the Netherlands.

A DCM specification must be

• usable within the HL7 Clinical Statement and HL7 template specification,
• meet HL7 terminfo requirements,
• adjustable to the CEN/IOS 13606 and OpenEHR archetype environment, and the Clinical template specification, among others.

Technical implementations that would be able to deploy DCM include GUI design, database design, HL7 message design, algorithm design, rule-based Decision Support System design, among others. In particular a DCM is to form a bridge between different technical representation formats, in particular HL7 v3 templates / clinical statements and OpenEHR archetypes. That is the harmonization aspect of DCM. In order to actually use a DCM, the transformation to HL7 must be made. This is done via mapping the DCM content to a Clinical Statement R-MIM, in any HL7 domain that uses Clinical Statement. The formalism to use a DCM in HL7 space would be that of an HL7 v3 template.

Project Team

Role	Name	Email	Notes
Project facilitator	William Goossen	williamtfgoossen@cs.com
Publishing facilitator	Jane Curry	janecurry@healthinfostrategies.com	Relation with Template Registry. To be discussed by William,Jane and Mark Schafeman before the HL7 WGM in May
Publishing facilitator	Jean Duteau	jean.duteau@gpinfornatics.com	To be discussed by William, Jean and Woody Beelers before the HL7 WGM in May
Vocabulary facilitator	HL7 Vocabulary Work Group
Modeling facilitator	Michael van der Zel	m.van.der.zel@ict.umcg.nl
Domain expert representative 1	Kevin Coonan	kevin.coonan@gmail.com
Domain expert representative 2	Anneke Goossen	agoossen@results4care.nl
Data Analyst facilitator
Business requirement analyst
Requirements process facilitator	Frank Oemig	hl7@oemig.de
Implementor	Ewout Kramer	e.kramer@furore.com

Action items

Action	Description	Timeline	Status
Analyse and model Glasgow Coma Scale for DSTU	An DCM for the Glascow Coma Scale is in enterprise archtect available for ballot.Also available is an export document so clinicians can give comment on the clinical content.	Informative ballot september 2010	In progress.
Revise Barthel index in PC DSTU and ISO 13606-3	An DCM for the Barthel index is in enterprise architect available for ballot. Also available is an export document so clinicians can give comment on the clinical content.	Informative ballot september 2010	In progress
Translate Dutch example scales into English	Examples are available. Different scales with different modeling issues should be choosen for balloting. the different examples must be modeled in EA. An export document must be made and available.	Informative ballot september 2010	To be discussed during the HL7 WGM in Rio de Janeiro
Identify use cases for larger scales and make new R-MIM for nested scales based on PC DSTU and Oemig’s set of scores and model and Coonans clinical examples	Last revisions underway before filing DSTU status.	Informative ballot september 2010	Status to be discussed in HL7 WGM in May 2010.
Proof of concept with Top 10 of items	Together with CIC (clinical), Terminfo (apply Snomed CT and or LOINC), Templates (authorization and registry) for 10 items (now 9).Simultaneous work. Send out the material now and ask for review feedback.	Informative ballot september 2010	In Progress. Material is available on the HL7 wiki. General feedback has been given. Yes must go on.
Specification how to link to the work in clinical groups	To be specified in the ballot. Before that a discussion in the clinical groups	May 2010	In Progress
Analyse the feedback on the actions above	Feedback given on the content of the DCM. Feedback given on the methodology of DCM.	After the ballot of september 2010	Waiting.
Outline a methodology for making DCM, checking for vocabulary requirements, template requirements	Based on the analysis of the feedback.	Informative ballot January 2011	Waiting.
Transform DCM to R-MIM, archetypes and EHR profiles	See DAM vs DCM vs SAEAF	Informative ballot 2011	Some progress made.
Develop a guideline for creating a DCM	Simultaneous work with work for the ISO standard and NIctiz. Include quality criteria for DCM.	Informative ballot september 2010	In progress
Publishing DCM in the HL7 repository	Contribution to the work done by Jane Curry, Mark Shafarman and Keith Boone	To be determined	Waiting.
Publishing the top 10 of DCM on the wiki HL7 Patient Care	Includes the Glasgow Coma Scale and the Barthel index. Open for feedback	Is published already	In Progress.
Publishing the examples DCM of some scales on the wiki HL7 Patient Care		May 2010	Waiting.
Publishing the guideline for creation of a DCM on the wiki HL7 Patient Care		May 2010	Waiting.
Develop and use metrics for quality criteria	This will be based on the work of Sunju Ahn from South Korea.This is put into ISO work as soon as this is allowed due to PhD obligations	After May 2010	Waiting.
Make a summary of different existing models, approaches and their implementation
Identify where work is done and future work should be done, in relationship with ISO and JIC
Do comparison of DCM work as in first motion	This is a follow up on the Cologne DCM meeting where some work started from
Create tooling to do DCM and exchange with other tools	A tool has been created in Enterprise Architect. This is ungoing work. Exchange with other tools is work to be done	Before 2011	In Progress
Identify a method for inclusion of DCM into the larger SAEAF picture of HL7 methodology	This included how to engage clinicians in particular in the HL7 space, and methods for how to go from DCM to HL7 templates and message artefacts. It will include also the position of DCM in the overall picture which is about decoupling semantics from constraining and from implementing. It should account why this reduces complexity in HL7 as a whole in keeping the clinical data element expression and use consistent. Patient care will accept the request to become an ARB SAEAF alpha project		In Progress
Set up joint meeting with ARB and MnN and publishing	This to ascertain that DCM fits in the overall SAEAF approach as part of methodology in HL7 and can be published for balloting	May 2010	In Progress
Identify dependencies for success and how these can be met	In particular to identify dependencies such as on a templates registry and specification, tooling, publishing and linkage to SAEAF	May 2010	In Progress
Submitting DCM to JIC	A particular approach was agreed roughly a year ago with the JIC chair. That is in particular to bring it to JIC once it is established as a project in both HL7 (May 2008) and ISO (July 2009). The plan has always been to bring the JWG requested projects to JIC	As soon as possible by William	In Progress

Remark: The actions came from the project scope statement, but must be reviewd by William Goossen as a co-chair of Patient Care.

Project Process

• Teleconferences on Wednesday at 4 pm Eastern time.

• Using Tooling's telecon. Will be announced via the Patient Care mailing list.

• Standing Agenda Items
  • Review of project plan and action items
  • Opportunity to ask questions and answers

Project Objectives and Deliverables

DCM Release 1 will support the following goals:

• Develop methods and tools requirements for binding of clinical content to terminology, to generic models and to different technical implementations using the same generic model. The first ballot will include a guideline for DCM creation.

• Identify a means to involve clinical groups to determine and specify relevant clinical content. This in line with the HL7 clinical interoperability council work and Domain Analysis Modelling (DAM), and HDF among others.

• Set up a methodology for verification, validation and quality, control and review cycle of clinical materials and their representation in terminology and information models so clinicians can trust the EHR and the message content presented to them. This will become part of the ISO 13972.

• Create a superset from which various applications, e.g. the CDA H&P, Detailed Clinical Models, DEEDS, etc. can draw data element identifiers in particular to provide a value set suitable for use in a clinical statement's Observation.code.

• Generate clinical value sets in both SNOMED-CT and in LOINC, according to Terminfo guidelines. This includes appropriate use of principles how information model and terminology model interact properly.

• Define and apply quality criteria for DCM clinical content, terminology, classification and unique coding, language translations, generic information modelling independent of a particular standard, transformations via tooling from generic models to standards specific modelling,

• Give guidelines for the linkage from a Domain Analyses Model to a HL7 D-MIM / R-MIM / template and/or archetype

• Develop transformation of generic model into HL7 v3 RIM / R-MIM / Clinical statement modelling and message development

• Develop transformation of generic model into CEN/ISO / OpenEHR archetypes

• Develop methods and tools to combine DCM into larger clinical templates

• Develop tools to combine archetypes / R-MIMs / DCM into different technologies

• Support actual use of DCM as clinical statements in messages (v2 and v3) and CDA (HL7 Patient Care / SD (CDA) / Clinical statement / O&O).

• Provide a forum to develop and maintain actual instances and artifacts for clinical content.

• Apply relevant metadata such as in the HL7 templates specification and ISO metadata ISO 11179.

• Set requirements, organise and develop a repository for DCM, serving the different clinical and standards organisations.

• Facilitate the re-use of materials and resources and prevent unnecessary duplication of efforts.

• The goal will be to ballot the DCM set Release 1 for normative status in first half of 2011 followed closely by implementation guide(s) that help promote interoperability across vendor implementations and across standards.

• At the end of this project, the DCM collection will be enhanced to better support the long-term goal of an automated standards-based information technology (IT) environment for the exchange of information supporting the process for clinical data collection and exchange to support continuity of care, aggregation of data and lifetime storage and retrieval, more or less independent of the actual technical implementations.

• Work products intended to produce a standard should be in terms of HL7 V3 deliverables, including but not limited to the following:
  • Make an inventory of examples already in the current HL7 v3 ballot domains
  • Clinical data specification guidelines and criteria
  • Methods how to apply
  • Storyboard, storyboard examples
  • State Transition Diagrams, trigger events where appropriate
  • Interaction Diagram, interactions
  • Message Information Models, Refined Message Information Models consistent with Clinical Statement and its derivates such as Care Statement
  • Hierarchical Message Definitions and XML examples that can be used as plug in for CDA and Care Provision Record message.
  • Implementation Guide for DCM within different standards and technical contexts
  • Tool criteria and tools for conversions
  • Repository of DCM, joint with CEN / ISO and OpenEHR including requirements from terminfo, template, 13606 and OpenEHR deliverables if applicable
  • Feasibility studies for using DCM in the different technologies.

Project Dependencies

• Semantic interoperability within relevant HL7 domains and with ISO and CEN standards, in particular the CEN/ISO 13606 series, archetypes, Open EHR and clinical templates.
• Support for work by ISO, CEN, OpenEHR within the ISO/CEN/HL7/ CDISC / IHTSDO Joint Initiative.
• The project is quite ambitious, and will only succeed if small parts are taken up as work items and lead to success. So one dependency is the ability of HL7 TC and other groups to derive concrete work plans from this overall project.
• Synchronize with intern HL7 work on registry of templates and apply authorization rules developed.
• Use HL7 wiki and set up a page for this.
• Synchronize with Terminfo rules in DSTU.
• Involvement of clinical organisations or bodies that guarantee the quality of clinical content: setting up a review cycle.

Project Timeline

Starting in September 2008, probably ending September 2011 as project, with unlimited responsibilities thereafter for repository maintenance and updating. -> adjustment must be made!

Project Resources

Most will be done in normal committee work time, and online via meetings, where all contributors have their normal responsibilities to develop DCM for their day job / clients / projects.

Project Budget

There will be a budget necessary for the HL7 repository

=Ballot strategy - general||

Revision of existing DSTU materials, inclusion of new scales into ballot and ongoing maintenance and new materials. Future normative will probably only possible if HL7 at large has established a repository of templates / R-MIMs.

Links to relevant documents

Templates Registry Pilot

Participants

DCM Contributors

Collaborating with	Agreement status	Comments
CEN	Existing
ISO	Existing
OpenEHR	Unknown	Informal agreement on this work