Standards vs Standardisation

I read Enrico Coiera's recent blog post Are standards necessary? with interest since it coincided with my posting of Oil & Water: research and standards. It was the use of the word 'standardisation' that caught my attention, as I think of it quite differently in my day-to-day work.

The clinical modelling domain should never be locked down in a formal standards framework. However it still requires a formal approach that provides a stable foundation while still allowing enough flexibility to cater for the dynamic clinical knowledge domain which grows in breadth, depth and complexity every day. This softer type of artefact governance is what I describe as 'standardisation' - a collaborative process, involving strong and transparent governance, that doesn't lock down the published artefacts so that they can't evolve as clinical requirements are recognised.

Within the clinical models environment we have:

  • a methodology that is evolving and becoming more robust;
  • an intent to create a coherent and integrated set of clinical models with both minimal overlap and minimal gaps
  • a process for governance, maintenance and distribution of the models; and
  • an evolving methodology towards federation and sharing of models.

Wikipedia refers to 'Standardization' (or 'Standardisation') as "the process of developing and implementing technical standards."

Merriam Webster's view is:

:  to compare with a standard; and

:  to bring into conformity with a standard

Whereas my experience of standardisation is with the clinical models ecosystem as a more organic, 'middle in' or grass-roots collaborative process which fits this other Merriam Webster definition more appropriately:

:  to change (things) so that they are similar and consistent and agree with rules about what is proper and acceptable.

It's all about the semantics.

So maybe I'm wrong. Maybe we are creating a form of standard with each clinical model after all, just with rules that differ to those usually found within a standards development organisation.

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!

Social media and #healthIT

Nominations for the #HIT100 list are in full swing. Well, at least it is full swing in the US. It doesn't seem to be making many waves elsewhere in the twitterverse - a curious phenomenon from my POV.

In the first #HIT100 list (2011), there were definitely 3 (maybe 4 or 5 at most, correct me if I'm wrong)  twits/tweeters/tweeple (whatever the correct term is) from outside the US. I remember two from Australia and one from UK. I know because I specifically went looking.

Certainly if you search for health IT-related topics on Twitter or follow some of the health IT related lists, the predominant topics are about US-based activity - Meaningful Use, ONC etc.

If you believe Twitter, then the US is the go-to place for all things health IT. But we know that is not the case. Clearly the use of social media, and specifically Twitter, is vastly different between USA and... well... anywhere else.

I nominated some people to the #HIT100 list this year. Most were non-US-based. My small attempt to try to subvert and upset the balance a little.

It was pleasing to see Keith Boone took a similar view.

I'll be very interested to see how the results of the nominations are presented. If it is truly not a personality or population contest then I would like to see the range of people highlighted, especially with an international focus to broaden the world view and enhance international discourse.

I see evidence of much excellent work happening all around the world related to eHealth, EHRs and health informatics but it is disproportionately represented if you rely on Twitter.

A curious dichotomy.

We need the domain experts!

It certainly helps to be a clinician, although recent work on development of clinical content specifications for a Hearing Health application has taken me further into modelling for the range of audiometry, 226Hz and high frequency tympanometry, audiology speech testing, and hearing screening than I’d ever imagined. Modelling the raw data capture (or downloaded from devices) for these tests is really quite simple, but enabling the complexity of different states, events and protocols that reflect audiological practice has been much more complex than I anticipated. I attempted to model these some years ago, based on my (obviously rather poor) research on the web at the time. Take a look at my meagre effort to build the original archetype for Audiogram Result (as built by a GP who has never performed an audiogram).

Audiogram Result Mindmap

See the full detail here -

And the most recent archetype as designed and verified by practising grassroots Audiologists… I didn’t even get the name of the concept correct!

Audiometry Result Mindmap

See the full detail here -

Identifying domain experts for the development and then collaboration on verification/validation of each type of archetype/template is absolutely critical for success.

Engaging clinicians: building EHR specifications

There is a methodology that is pragmatically evolving from my experience in openEHR clinical modelling work over the past few years. It has developed in a rather ad hoc way, and totally in response to working directly with clinicians. The simplicity and apparent effectiveness – both for me and the clinicians involved - continues to surprise me each time I use it. The clinical content specifications for specialised health records and care plans that we are building are being developed with a sequence of expert input and clinical verification:

  1. Identifying the clinical requirements and business rules in conjunction with a selected initial domain expert group;
  2. Broader abstract verification of the notion of ‘maximal data set’ for ‘universal use case’ during formal archetype review cycles;
  3. Contextual validation during template review by ‘on-the-ground’ clinicians; and finally, although to a lesser degree,
  4. Validation during mapping and migration of legacy data.

With each project I am refining this process. Starting off a project with face-to-face meetings has been a ‘no brainer’ – after all, it takes a while for everyone to understand the get the idea of what we are doing. However after initial workshops, pretty much everything else can be done via web conference, online collaboration via CKM and email.

I find the initial workshops are usually greatly satisfying. Within hours we can be creating two outputs – a mind map that reflects the clinicians evolving conversation about their requirements and, in parallel, an equally agile template of clinical content specifications that can be verified by the clinicians in real time.

The mind map is displayed on a shared screen or via a data projector and acts as a living document, evolving as we talk through the clinical requirements, and identify the complexities, dependencies and relationships of all the components. The final mind map may be surprisingly different to how it started, and at the end of the conversation, the clinicians can verify that what they’ve said if accurately reflected in the mind map. It is an open source tool, so we can also share this around after the workshop for further comments.

Subsection of a mind map

Most recently I have begun building a template on the fly during the workshop, using any existing archetypes that are available, and identifying gaps or the need for new archetypes on the mind map as we go. In this way we are actually building the content specification in front of the clinicians as well. They get an understanding of how the abstract discussion will actually shape the resulting EHR content and they can verify it as we gradually pull it together. The domain experts are immediately equipped to answer the question: “Does this specification match what you have been telling me you do in practice?”

Same subsection of the mindmap as a template specification

This methodology seems to bring the clinicians along with us on the clinical modelling journey, and most are able to understand at least some of the implications of some of our requirements discussions and, in particular, the ‘shape’ of the data that we can collect. It is a process seems to suit the thinking process of many clinicians and the overwhelmingly consistent feedback from recent workshops is that they have all actually enjoyed the experience and want to know what are the next steps for them to be involved. So that’s certainly a winner.

And the funders/jurisdictions are anecdotally confirming for me that they are finding that this approach is supporting higher quality specifications in a much shorter time frame.

For example, at a project kickoff workshop for a new project recently, in two days we:

  • developed a series of mind maps capturing a consensus view of the clinical requirements and business processes;
  • identified all the archetypes required for the entire project, including those that existed and were ‘fit for use’, those that needed some extension to meet requirements and new archetypes that needed to be created;
  • identified sources of information or mind mapped the requirements for each new archetype identified; and
  • built 3 templates comprising all of the existing archetypes available from a number of sources – the NEHTA CKM, the openEHR international CKM and local drafts that I had on my own computer. For a number of the new archetypes we also collectively identified source information that would inform or be the basis for the archetype development.

All of this described above took 8 medical practitioners clinicians away from their everyday practice for only 1-2 days, each according to their availability. Yet it provided the foundation for development of a new clinical application.

Then I go home. Next steps are to refine the mind map, modify/update/specialise any archetypes for which we have identified new requirements and build the new ones. And in parallel start the collaborative process through a CKM project to ensure that existing and modified archetypes are ‘fit for (our project’s) purpose’, and to upload and initiate reviews on the new draft archetypes.

All work to progress these archetypes to maturity (ie aiming for clinical consensus) and then validate the templates as ready for handover to the implementers can be done online, asynchronously and at a time convenient to the clinicians work/life balance!

Clinician-friendly view of the same template in CKM

I live over 2000 kilometres away from these clinicians. Yet the combination of web conference and CKM enables us to operate as an ongoing collaborative team. It seems to be working well at the moment... No doubt I'll continue to learn how to do it better.

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.Archetype ecosystem

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.mindmapOver 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 nth 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...

The White Wizard is Walking

I received my Walking Jacket at the reception desk of my Italian hotel. I'd just paid an exorbitant amount of tax in exchange for receive my jacket from the Italian Postal Service for my trusty, favourite jacket to be turned into a disruptive artwork by @ReginaHolliday. I first wore it to the Medical Informatics Europe Conference in Pisa in August 2012 and then to the ISO TC 215 meeting in Vienna the following September. I'd heard about Regina and her family's story some time before, my awareness raised purely through the twitter community, and then finding images of her 73 cents mural. I finally met her at HIC12, the Australian health informatics conference in Sydney in early August.

Regina was a keynote speaker and during her HIC address, many in the audience were clearly moved. It is the only presentation that I have seen in the health IT environment that received a standing ovation – powerful stuff. It polarised people. Most loved it and felt inspired; some thought it inappropriate in a healthIT conference – go figure!

Regina and I talked one night at dinner. She offered to paint me a jacket. I felt a bit like a fraud – I have no special patient data faux pas story to tell. My involvement in health IT stems from having a long-term engagement with the health system from the tender age of 5; about how that influencing my decision to become a doctor; and my subsequent, almost accidental, slip sideways into health informatics. Nowadays my work focus is firmly on getting health data right, working collaboratively with international clinicians to agree on common definitions about how to represent clinical content in electronic health records.

fulljacketAnd yet here is my jacket – a favourite that I bought way back in 2000 for my first foray out of clinical practice and into the corporate world - my first step into health informatics. I hadn't worn it for a while and Regina's painting has given it a new lease of life. It now has its own story - having travelled to the US to be painted, on to Europe to be worn for the first time in Italy and Vienna, and now back home to Australia.

Regina hasn't explained the image to me. I've asked … and waited. She promised to blog about it, but I think I'll be waiting a while. In her gallery of jackets that tell personal stories, mine is number 176.

So let me share what I think it portrays…

I was hit by a car when I was five years old. As a result I started my first day of school on crutches and in plaster from my waist to my right ankle – that young girl on crutches and wearing a caliper is me. Mini-me!

That accident resulted in some permanent problems and I ended up experiencing a series of operations during my childhood and early teenage years. Way too much time was spent in hospital than was healthy, but I still remember telling my orthopaedic surgeon that I wanted to be a Nurse. I remember him saying 'Rubbish. You shouldn't do that much walking. You should be a Doctor, instead"! Maybe it planted a seed. I don't remember it influencing my decision to enter medicine, but that is where I found myself. I'm not sure that as a young intern and resident years we walked less than the nurses – my memory is we never stopped running!

I practiced medicine for over 15 years, gradually side-stepping into health informatics as I joined my husband in developing, marketing, selling, supporting one of the first prescribing systems in Australia. He was the geek GP, passionate to combine his love of clinical practice with technology. I merely agreed to support him in his venture, having absolutely no idea what I was getting myself into.

That kickstarted the health informatics chapter of my life – 17 years duration to date - which has propelled my husband and myself jointly into the world of business, from cottage industry to large corporate consulting firms, and travel to some extraordinary places.

topjacketThe adult woman in Regina's image is also me – as the 'omowizard'. This has become my online persona, largely now related to Twitter and blogging. 'omowizard' originated from a love of Tolkien and seeking a Hotmail account back in 2000. Gandalf was taken, as was the 'white wizard'. So given my laundry responsibilities for my young family at the time, I became whiter than white – the Omo wizard. For those unaware, Omo is a brand of clothes washing powder that at the time claimed to wash clothes 'whiter than white'! I never dreamed anyone else would ever have to know or understand that, not even when I experimented on Twitter for the first time as @omowizard. Now it is probably too late to change :)

In the painting I am standing in isolation on a very tall, narrow, bleak pillar. I'm not quite sure what that is representing. Some have suggested a reference to Sauron's tower in Lord of the Rings, but maybe that's too fanciful! I certainly don't have any magic powers. My youngest child informed me recently that I have a strong maternal death stare as a superpower, but I don't think that counts. Maybe it represents the approach that we have been using to standardise the clinical content for health records. It is known as openEHR and although I have been heavily involved in developing the clinical modelling side of it – building archetypes and training others. It has stood in isolation for many years and outside of the mainstream approaches to health IT, but in recent years has become recognised and is gaining increasing recognition as a significant contributor towards the goal of semantic interoperability. Only Regina knows the answer to this one!

bottomjacketThe ribbons or strands entwining around the tower are really interesting to me. The main one rippling across the tower reads: "A house divided against itself cannot stand". This appears to be a direct reference to Jesus' words in Matthew 12:25 – "He knew what they were thinking and told them, "Every kingdom divided against itself is destroyed, and every city or household divided against itself will not stand." (NIV 2012). Abraham Lincoln used the phrase in a speech to Republican candidates at the Republican State Convention on June 16, 1858 relating to the danger of slavery-based disunion. Apparently it is still used sometimes in political speeches, calling for unity and working together for a common goal.

The lowest ribbon says simply, 'openEHR'; the one immediately to its right, 'HL7'; and just above it, 'Standards and Interoperability'.

I had described the approach that we are taking with our openEHR clinical modelling to Regina as one in which we are engaging with clinicians and domain experts to verify that the computable definitions that we are building in openEHR systems are fit for purpose. It is a collaborative approach that is crowdsourcing clinical expertise using the Clinical Knowledge Manager tool. For many years there had been little engagement with the HL7 community as a whole, although recently there appear to have been a softening of the lines of political demarcation. Those not constrained by political blinkers can see there could be significant mutual benefit from openEHR content definitions being used within HL7 constructs. Who knows if this will eventuate? And then there are other opportunities such as the CIMI and FHIR projects… Collaborating is the key.

So I interpret the ribbons yielded by the omowizard as another way of Regina calling for collaboration and collective action in healthIT. It seems that she is portraying me as a coordinator of some of the standardisation occurring in healthIT around the archetype work – using the @omowizard's twitter and blogging being one of the means to coordinate and share the passion, perhaps!

I love the painting but in trying to interpret it, it is not a comfortable image for me. I don't like being the focus. I am certainly enjoying my small bit part in the openEHR clinical modelling and health IT standards world. I have come to openEHR when it was relatively immature. We are seeing it grow and become established, but it is definitely not my idea or vision. I'm just one of number who have had the exciting opportunity of being a facilitator for something that I believe will make a difference.

I hope that when I wear this jacket it will trigger some discussions that might further progress in sharing health information and impacting the provision of health care – that is reason enough to wear it.

Thankyou, Regina. My jacket is a piece of art that is beautiful to look at; It is a powerful statement when understood in context of its origins; and is potentially a disruptive force when considered as part of the larger international Walking Gallery movement. I look forward to more opportunities to wear it at home in Australia and in my travels.