Archetypes/DCMs MIA in SDOs

Curious to note that there is very little apparent interest in detailed clinical information models (DCMs) of any brand or flavour in the major Standards Development Organisations (SDO’s) – they are effectively Missing In Action when compared to the likes of CDA and IHE profiles.

The ISO 13972 DCM specification took a long and tortuous time to travel through the ISO TC 215 processes. Engagement with 13972 during its development, and from what I can observe now it is on the verge of publication has been rather sparse.  A further piece of work is now starting in ISO regarding quality criteria for DCMs but it also seems to be struggling to find an audience that understands it, or even cares.

I don’t quite understand why the concept of DCMs has not been a big ticket item on the radar of the SDOs for a long time as it is a major missing piece of any standards-based framework. Groups like CIMI are raising awareness, alongside the openEHR work, so momentum is gathering, but for some reason it seems to keep a very understated profile compared to new opportunities like FHIR in HL7.

The work of messages, documents, profiles and terminologies are clearly important for interoperability, but standardisation of clinical content models working closely with terminologies can potentially make the work required to develop messages, documents, and profiles orders of magnitude easier.

Let me test a metaphor on you. Think of each message, document or profile as a sentence and each archetype or DCM as a word, a building block that is one component of each sentence. By focussing on the building a specific sentence, we are working backwards by trying to determine the components, and the outcome is still just that single sentence. However if we start by standardising the words/archetypes, then once they are stable it is relatively simple to construct not only one sentence for a specific purpose, but the potential is a much greater output in which many more additional sentences can be created using a variety of words in different combinations. If we manage the words (archetypes) as core building blocks and get them right, then we allow a multitude of possible sentences (messages/documents/profiles) to proliferate.

The ‘brand’ of archetype/DCM solution does not concern me so much as raising awareness that clinician-led, standardised clinical content is a significant missing and overlooked piece of the international eHealth foundations puzzle.

Archetypes: health data bridges

What do we want for our health data – silos of information models for different purposes or ones that bridge multiple use cases?

From a series of emails shared on the HL7 Patient Care email list in the past few days…

Grahame Grieve (FHIR, HL7):

“Heather, you need to keep in mind the difference between FHIR and clinical models: it’s not our business to say not to exchange data that people do have because some user in an edge case might not understand it. We define an exchange standard, not a clinical UI standard…”

and

“Heather, do not lose sight of the difference between a clinical standard for what care/records should be, and FHIR, which is an IT standard for how care records are.”

My response:

“…I am concerned about developing another standard that you state clearly is only designed for exchange and not for what care records should be. If we are not designing to try to harmonise data requirements for health information exchange, how clinical care records are and how clinical care records should be, then we are building siloes of data structures again, that will require mappings and transforms ad infinitum. I’d hate to see us end up with a standard for exchange that can’t be implemented for persistence”…

If we end up with models for exchange, models representing current data in systems (whether or not they represent good clinical practice and models that are regarded as the roadmap for good data, then what have we got? Three sets of data models that perpetuate the nightmare of non-interoperability.

Our openEHR archetypes are attempting to bridge all of these. Use them in whatever context you choose – messages, document exchange, EHR persistence, CDS, secondary use, aggregation and analysis, querying etc. The ‘secret sauce’ is the use of a second layer of modelling – the template, that allows the correct expression of the archetype appropriate for the context of use.

Mappings and transformations are acceptable where we don’t have any choice, especially with legacy data, but they open us up to vulnerabilities from errors, misinterpretation and ambiguity, concerns re data integrity and possible overt data loss. Given the choice, lets work towards creating high quality data that can be re-used in multiple contexts safely.

Oil & water: research & standards

The world of clinical modelling is exciting, relatively new and most definitely evolving. I have been modelling archetypes for over 8 years, yet each archetype presents a new challenge and often the need to apply my previous experience and clinical knowledge in order to tease out the best way to represent the clinical data. I am still learning from each archetype. And we are still definitely in the very early phases of understanding the requirements for appropriate governance and quality assurance. If I had been able to discern and document the ‘recipe’, then I would be the author of a best-selling ‘archetype cookbook’ by now. Unfortunately it is just not that easy. This is not a mature area of knowledge.

I think clinical knowledge modellers are predominantly still researchers.

In around 2009 a new work item around Detailed Clinical Models was proposed within ISO. I was nominated as an expert. I tried to contribute. Originally it was targeting publication as an International Standard but this was reduced to an International Specification in mid-development, following ballot feedback from national member bodies. This work has had a somewhat tortuous gestation, but only last week the DCM specification has finally been approved for publication – likely to be available in early 2014. Unfortunately I don’t think that it represents a common, much less consensus, view that represents the broad clinical modelling environment. I am neither pleased nor proud of the result.

From my point of view, development of an International Specification (much less the original International Standard) has been a very large step too far, way too fast. It will not be reviewed or revised for a number of years and so, on publication next year, the content will be locked down for a relatively long period of time, whilst the knowledge domain continues to grown and evolve.

Don’t misunderstand me – I’m not knocking the standards development process. Where there are well established processes and a chance of consensus amongst parties being achieved we have a great starting point for a standard, and the potential for ongoing engagement and refinement into the future. But…

A standards organisation is NOT the place to conduct research. It is like oil and water – they should be clearly separated. A standards development organisation is a place to consolidate and formalise well established knowledge and/or processes.

Personally, I think it would have been much more valuable first step to investigate and publish a simple ISO Technical Report on the current clinical modelling environment. Who is modelling? What is their approach? What can we learn from each approach that can be shared with others?

Way back in 2011 I started to pull together a list of those we knew to be working in this area, then shared it via Google Docs. I see that others have continued to contribute to this public document. I’m not proposing it as a comparable output, but I would love to see this further developed so the clinical modelling community might enhance and facilitate collaboration and discussion, publish research findings, and propose (and test) approaches for best practice.

The time for formal specifications and standards in the clinical knowledge domain will come.  But that time will be when the modelling community have established a mature domain, and have enough experience to determine what ‘best practice’ means in our clinical knowledge environment.

Watch out for the publication of prEN/ISO/DTS 13972-2, Health informatics – Detailed clinical models, characteristics and processes. It will be interesting to observe how it is taken up and used by the modelling community. Perhaps I will be proven wrong.

With thanks to Thomas Beale (@wolands_cat) for the original insight into why I found the 13972 process so frustrating – that we are indeed still conducting research!