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!

The Archetype Journey...

I'm surprised to realise I've been building archetypes for over 7 years. It honestly doesn't feel that long. It still feels like we are in the relatively early days of understanding how to model clinical archetypes, to validate them and to govern them. I am learning more with each archetype I build. They are definitely getting better and the process more refined. But we aren't there yet. We have a ways to go! Let me try to share some idea of the challenges and complexities I see…

We can build all kinds of archetypes for different purposes.

There are the ones we just want to use for our own project or purpose, to be used in splendid isolation. Yes, anyone can build an archetype for any reason. Easy as. No design constraints, no collaboration, just whatever you want to model and as large or complex as you like.

But if you want to build them so that they will be re-used and shared, then a whole different approach is required. Each archetype needs to fit with the others around it, to complement but not duplicate or overlap; to be of the same granularity; to be consistent with the way similar concepts are modelled; to have the same principles regarding the level of detail modelled; the same approach to defining scope; and of course the same approach to defining a clinical concept versus a data element or group of data elements… The list goes on.

Some archetypes are straightforward to design and build, for example all the very prescriptive and well recognised scales like the Braden Scale or Glasgow Coma Scale. These are the 'no brainers' of clinical modelling.

Some are harder and more abstract, such as those underpinning a clinical decision support system of orders and activities to ensure that care plans are carried out, clinical outcomes achieved and patients don't 'fall through the cracks' from transitions of care.

Then there are the repositories of archetypes that are intended to work as single, cohesive pool of models – each archetype for a single clinical concept that all sits closely aligned to the next one, but minimising any duplication or overlap.

That is a massive coordination task, and one that I underestimated hugely when we embarked on the development of the openEHR Clinical Knowledge Manager, and especially more recently, the really active development and coordination required to manage the model development, collaboration and management process within the Australian CKM – where the national eHealth program and jurisdictions are working within the same domain of models, developing new ones for specific purposes and re-using common, shared models for different use cases and clinical contexts.

The archetype ecosystems are hard, numbers of archetypes that need to work together intimately and precisely to enable the accurate and safe modelling of clinical data. Physical examination is the perfect example that has been weighing on my mind now for some time. I've dabbled with small parts of this over the years, as specific projects needed to model a small part of the physical exam here and there. My initial focus was on modelling generic patterns for inspection, palpation, auscultation and percussion – four well identified pillars of the art of clinical examination. If you take a look at the Inspection archetype clinicians will recognise the kind of pattern that we were taught in First Year of our Medical or Nursing degrees. And I built huge mind maps to try to anticipate how the basic generic pattern could be specialised or adapted for use in all aspects of recording the inspection component of clinical examination.Over time, I have convinced myself that this would not work, and so the ongoing dilemma was how to approach it to create a standardised, yet extraordinarily flexible solution.

Consider the dilemma of modelling physical examination. How can we capture the fractal nature of physical examination? How can we represent the art of every clinician's practice in standardised archetypes? We need models that can be standardised, yet we also need to be able to respond to the massive variability in the requirements and approach of each and every clinician. Each profession will record the same concept in different levels of detail, and often in a slightly different context. Each specialty will record different combinations of details. Specialists need all the detail; generalists only want to record the bare basics, unless they find something significant in which case they want to drill down to the n^th degree. And don't forget the ability to just quickly note 'NAD' as you fly past to the next part of the examination; for rheumatologists to record a homunculus; for the requirement for addition of photos or annotated diagrams! Ha – modelling physical examination IS NOT SIMPLE!

I think I might have finally broken the back of the physical examination modelling dilemma just this week. Seven years after starting this journey, with all this modelling experience behind me! The one sure thing I have learned – a realisation of how much we don't know. Don't let anyone tell you it is easy or we know enough. IMO we aren't ready to publish standards or even specifications about this work, yet. But we are making good, sound, robust progress. We can start to document our experience and sound principles.

This new domain of clinical knowledge management is complex; nobody should be saying we have it sorted...

Archetype Re-use

Last Thursday & Friday @hughleslie and I presented a two day training course on openEHR clinical modelling. Introductory training typically starts with a day to provide an overview – the "what, why, how" about openEHR, a demo of the clinical modelling methodology and tooling, followed by setting the context about where and how it is being used around the world. Day Two is usually aimed at putting away the theoretical powerpoints and getting everyone involved - hands on modelling. At the end of Day One I asked the trainees to select something they will need to model in coming months and set it as our challenge for the next day. We talked about the possibility health or discharge summaries – that's pretty easy as we largely have the quite mature content for these and other continuity of care documents. What they actually sent through was an Antineoplastic Drug Administration Checklist, a Chemotherapy Ambulatory Care Nursing Intervention and Antineoplastic Drug Patient Assessment Tool! Sounded rather daunting! Although all very relevant to this group and the content they will have to create for the new oncology EHR they are building.

Perusing the Drug Checklist ifrst - it was easily apparent it going to need template comprising mostly ACTION archetypes but it meant starting with some fairly advanced modelling which wasn't the intent as an initial learning exercise.. The Patient Assessment Tool, primarily a checklist, had its own tricky issues about what to persist sensibly in an EHR. So we decided to leave these two for Day Three or Four or..!

So our practical modelling task was to represent the Chemotherapy Ambulatory Care Nursing Intervention form. The form had been sourced from another hospital as an example of an existing form and the initial part of the analysis involved working out the intent of the form .

What I've found over years is that we as human beings are very forgiving when it comes to filling out forms – no matter how bad they are, clinical staff still endeavour to fill them out as best they can, and usually do a pretty amazing job. How successful this is from a data point of view, is a matter for further debate and investigation, I guess. There is no doubt we have to do a better job when we try to represent these forms in electronic format.

We also discussed that this modelling and design process was an opportunity to streamline and refine workflow and records rather than perpetuating outmoded or inappropriate or plain wrong ways of doing things.

So, an outline of the openEHR modelling methodology as we used it:

1. Mind map the domain – identify the scope and level of detail required for modelling (in this case, representing just one paper form)
2. Identify:
   1. existing archetypes ready for re-use;
   2. existing archetypes requiring modification or specialisation; and
   3. new archetypes needing development
3. Specialise existing archetypes – in this case COMPOSITION.encounter to COMPOSITION.encounter-chemo with the addition of the Protocol/Cycle/Day of Cycle to the context
4. Modify existing archetypes – in this case we identified a new requirement for a SLOT to contain CTCAE archetypes (identical to the SLOT added to the EVALUATION.problem_diagnosis archetype for the same purpose). Now in a formal operational sense, we should specialise (and thus validly extend) the archetype for our local use, and submit a request to the governing body for our additional requirements to be added to the governed archetype as a backwards compatible revision.
5. Build new archetypes – in this case, an OBSERVATION for recording the state of the inserted intravenous access device. Don't take too much notice of the content – we didn't nail this content as correct by any means, but it was enough for use as an exercise to understand how to transfer our collective mind map thoughts directly to the Archetype Editor.
6. Build the template.

So by the end of the second day, the trainee modellers had worked through a real-life use-case including extended discussions about how to approach and analyse the data, and with their own hands were using the clinical modelling tooling to modify the existing, and create new, archetypes to suit their specific clinical purpose.

What surprised me, even after all this time and experience, was that even in a relatively 'new' domain, we already had the bulk of the archetypes defined and available in the NEHTA CKM. It just underlines the fact that standardised and clinically verified core clinical content can be re-used effectively time and time again in multiple clinical contexts.The only area in our modelling that was missing, in terms of content, was how to represent the nurses assessment of the IV device before administering chemo and that was not oncology specific but will be a universal nursing activity in any specialty or domain.

So what were we able to re-use from the NEHTA CKM?

• COMPOSITION.encounter
• EVALUATION.adverse_reaction – one instance per adverse reaction included in a adverse reaction list
• EVALUATION.clinical_synopsis
• EVALUATION.problem_diagnosis – one instance per diagnosis included in a problem list
• INSTRUCTION.request-referral – one instance per referral requested
• ACTION.health_education
• ACTION.procedure – with two instances for different purposes

…and now that we have a use-case we could consider requesting adding the following from the openEHR CKM to the NEHTA instance:

• OBSERVATION.story
• CLUSTER.symptom – with multiple instances for each symptom identified

And the major benefit from this methodology is that each archetype is freely available for use and re-use from a tightly governed library of models. This openEHR approach has been designed to specifically counter the traditional EHR development of locked-in, proprietary vendor data. An example of this problem is well explained in a timely and recent blog - The Stockholm Syndrome and EMRs! It is well worth a read. Increasingly, although not so obvious in the US, there is an increasing momentum and shift towards approaches that avoid health data lock-in and instead enable health information to be preserved, exchanged, aggregated, integrated and analysed in an open and non-proprietary format - this is liquid data; data that can flow.

The Times, They Are a-Changin’...

Channelling Bob Dylan? Not quite! But it is interesting to see some emerging HL7 and openEHR activity, at least in this little part of the world – Australia and New Zealand :) Maybe this is a model for the rest of the world - at least food for thought!

For too many long years there appears to have been a palpable barrier between the HL7 and openEHR communities. Some individuals have managed to bridge it, but there has definitely been a reluctance to engage at organisational level. It stems from before my time; I suspect vocal personalities with strong, diverging opinions were at the root. To some, it is a little like a religious argument – where "only my way is the right way"!

Be that as it may - the barrier appears to be softening and became evident to me for the first time back in January last year as I attended the HL7 meeting in Sydney. A full day openEHR workshop was presented by a diverse group of Australian companies plus NEHTA experts; Bob Dolin in attendance, amongst others. Keith Boone tweeted his initial impression of the openEHR approach after I demonstrated our tooling and then blogged about it. My thoughts were captured in my Adventures of a clinician in HL7 post.

Fast forward to 2012…

You may have seen some announcements from New Zealand. Firstly, publication in April of the Health Information Exchange Architecture Building Blocks where they specified "2.3.2 The data definitions of the Content Model shall be formulated as openEHR archetypes" within the "10040.2 HIE Content Model, a framework for the creation of a common set of logical data definitions" document.

And secondly: HL7 New Zealand and the openEHR Foundation signed a Statement of Collaboration - also announced April 2012. Now there's a headline that might have been a surprise to many – HL7 NZ & openEHR clearly intending to work closely together!

Only last Thursday Hugh Leslie & I participated in a seminar, "Bringing the Electronic Health Record to Life," organised by HL7 NZ, Health Informatics New Zealand (HINZ) and the University of Auckland. Prof Ed Hammond, 'the father of HL7', keynoted the meeting: "EHR - The Killer App". In the afternoon mini-tutorials, David Hay presented on FHIR, and Hugh, I and Koray Atalag presented a little about our openEHR work, including clinical knowledge governance and clinician engagement. Koray (a HL7 NZ member and openEHR localisation program coordinator) announced within the meeting that HL7 NZ is the likely organisation to auspice a NZ chapter of openEHR. Now that definitely has to start to change the openEHR/HL7 dynamic somewhat, even if HL7 NZ is a relatively small international affiliate :). The HL7 NZ leadership, to their absolute credit, are certainly not being constrained by any traditional 'turf wars'.

The following day, last Friday, Hugh and I presented a full day workshop on openEHR, again sponsored by HL7 NZ, HINZ and the University of Auckland. As I understand it, this was the first opportunity for the openEHR approach to be socialised with the broader healthIT community in NZ; about 25 in attendance including members of the HL7 NZ Board, vendors, and regional and HealthIT Board reps. The focus was on how openEHR could support the creation of a range of technical artefacts to meet NZ's requirements for CDA messaging (and beyond), generated from a cohesive and governed pool of clinical content models.

Interestingly we had a surprise attendee for the workshop – Ed Hammond joined us for the whole day. I won't presume to guess what Ed has taken away from the day, although he did offer up a comment to the group about the value of exploring use of archetype content directly within CDA.

Post workshop one of the attendees tweeted:

"At #HINZ #openEHR talks last 2 days. openEHR is a fantastic foundation for practical action. Left knowing steps I will take. How cools that!"

And of course, there is an HL7 AU meeting in Sydney early next week entitled "FHIR?  CIMI? openEHR? What's the Future of eHealth & mHealth Standards?" The agenda:

• Keynote: Ed Hammond (again) – "FHIR, CIMI and openEHR - What's the Future for eHealth Standards?". [It will be very interesting to hear his opinion after last week's openEHR exposure.]
• Grahame Grieve: "FHIR – What is it? Why has it suddenly become so popular?"
• Hugh Leslie: "Recent developments in openEHR and CDA", and
• I'll be reporting on the CIMI project.

It would be an interesting day to be a fly on the wall! 2 HL7-ers and 2 openEHR-ers addressing an HL7 meeting - all exploring alternatives to the current approaches!

So, keep your eye on the space where HL7 intersects with openEHR – might be some interesting developments.

_______________________

Within the openEHR community, and definitely within Ocean Informatics where I work, we are certainly finding that significant interest is being certainly generated from many sources about the process of using standardised and governed openEHR clinical content as a means to generate range of technical artefacts, including CDA. The New Zealand national interest and activity is evident, as outlined above. And in addition:

• In Australia, NEHTA has piloted the use of clinician-reviewed archetypes from the NEHTA Clinical Knowledge Manager as the start point for generating a number of the PCEHR technical specifications. This work is ongoing and being extended.
• CIMI, the initiative that grew out of HL7 but is now independent, is seeking to develop an internationally agreed approach to clinical modelling and generation of multiple technical outputs. It has already agreed to utilise openEHR ADL 1.5 as its modelling formalism and is using the openEHR Reference Model as the starting point for developing a CIMI Reference Model. We watch this progress with interest.
• And Brazil's national program has recently reconfirmed its intention to commence using openEHR.

Whether the final solution is openEHR or CIMI or even something else, I think that the advent of standardised clinical models as the common starting point for generation of a range of technical outputs is upon us. Ignore it at your peril. And specifically, I would suggest that HL7 International should be considering very seriously how to embrace this new approach.

Sticking with the quasi-gospel theme, maybe it is now a bit more like Curtis Mayfield's "People Get Ready":

People get ready There's a train a-coming You don't need no baggage Just a-get on board

Let's leave our baggage behind, get on the 'train' together to collaborate and create something that transcends any health IT domain turf war! Don't get left behind...

Clinical Knowledge Repository requirements

I've been hearing quite a lot of discussion recently about Clinical Knowledge Repositories and governance. Everyone has different ideas - ranging from sharing models via a simple subversion folder through to a purpose-built application managing governance of combinations of versioned knowledge assets (information models, terminology reference sets, derived artefacts, supporting documentation etc) in various states of publication. It depends what you want to achieve, I guess. In openEHR it became clear very quickly that we need the latter in order to provide a central resource with governance of cohesive release sets of assets and packages suitable for organisations and vendors to implement.

In our experience it is relatively simple to develop a repository with asset provenance and user management. What is somewhat harder is when you add in processes of collaboration and validation for these knowledge assets - this requires development of review and editorial processes and, ideally, display transparency and accountability on behalf of those managing the knowledge artefacts.

The most difficult scenario reflects meeting the requirements for practical implementation, where governance of configurable groups of various assets is required. In openEHR we have identified the need for cohesive release sets of archetypes, templates and terminology reference sets. This can be very complicated when each of the artefacts are in various states of publication and multiple versions are in use in 'on the ground' implementations. Add to this the need for parallel iso-semantic and/or derived models, supporting documents, and derived outputs in various stages of publication and you can see how quickly chaos can take over.

So, what does the Clinical Knowledge Manager do?

1. CKM is an online application based on a digital asset management system to ensure that the models are easily accessed and managed within a strong governance framework.
2. Focus:
   1. Accessible resource - creation of a searchable library or repository of clinical knowledge assets - in practice, a ‘one stop shop’ for EHR clinical content
   2. Collaboration Portal - for community involvement, and to ensure clinical models that are ‘fit for clinical use’
   3. Maintenance and governance of all clinical knowledge and related resources
3. Processes to ensure:
   1. Asset management
      1. uploading, display, and distribution/downloading of all assets
      2. collaborative review of primary* assets  to validate appropriateness for clinical use
         1. content
         2. translation
         3. terminology binding
      3. publication life cycle and versioning of primary assets
      4. primary asset provenance, differential and change log
      5. automatic generation of secondary**/derived assets or, alternatively, upload and versioning when auto generation is not possible
      6. upload of associated***/related assets
      7. development of versioned release sets of primary assets for distribution
      8. identify related assets
      9. quality assessment of primary assets
      10. primary asset comparison/differentials including compatibility with existing data
      11. threaded discussion forum
      12. flexible search functionality
      13. coordinate Editorial activity
      14. share notification of assets to others eg via email, twitter etc
   2. User management
   3. Technical management
   4. Reporting
      1. Assets
      2. Users
      3. Editorial activity support

In current openEHR CKM the assets, as classified above, are:

1. *Primary assets:
   1. Archetypes
   2. Templates
   3. Terminology Reference Set
2. **Secondary assets:
   1. Mindmaps
   2. XML transforms
   3. plus ability to add transforms to many other formalisms, including CDA
3. ***Associated assets:
   1. Design documents
   2. References
   3. Implementation guides
   4. Sample data
   5. Operational templates
   6. plus ability to add others as identified

While CKM is currently openEHR-focused - management of the openEHR artefacts was the original reason for it's development - with some work the same repository management, collaboration/validation and governance principles and processes, identified above, could be applied for any knowledge asset, including all flavors of detailed clinical models and other clinical knowledge assets being developed by CIMI, or HL7 etc. Yes, CKM is a currently a proprietary product, but only because it was the only way to progress the work at the time - business models can always potentially be changed :)

It will be interesting to see how thinking progresses in the CIMI group, and others who are going down this path - such as the HL7 templates registry and the OHT proposed Heart project.

We can keep re-inventing the wheel, take the 'not invented here' point of view or we can explore models to collaborate and enhance work already done.