Not all CKMs are created equal

Despite using the same underlying tool, not all CKMs are equal. Rather than ‘one CKM to rule them all’, each CKM exists for a specific reason – for example intent, geographical domain, servicing a common community. This allows countries, organisations or programs to operate autonomously from each other when they need to. All CKMs operate independently of each other, with their own Editors and Administrators.

CKMs support some baby steps towards federation but this is hugely complex and a problem not yet able to be resolved. The tension can only be managed by the administrators governing each CKM, and the risk is significant divergence or conflicts between models.

So, when searching for archetypes to use in data sets it is important to know where to look, the focus and context of each archetype, and therefore have insight into the pros and cons of each model. Each CKM may have different ways of governing its archetypes and so choosing the best archetype for a given purpose is not necessarily straightforward. This doesn’t mean that you shouldn’t try to identify useful archetypes in various CKMs, you just need to understand any potential consequence of your choice.

There are currently five public CKMs:

1.       The openEHR International CKM is commonly described as the ‘source of truth’ for most openEHR modellers. It is ambitious, and by no means perfect, but the goal is to create a coherent health data ecosystem of shared clinical models, avoiding overlap and minimising gaps, reusable across multiple clinical scenarios – effectively establishing a universal health language. Supporting semantic interoperability is the cornerstone of the openEHR CKM and this intent is one of the key differentiators from some other CKMs.
In this context, the underlying philosophy of archetype design is a proactive approach to ‘deconstructing clinical knowledge’, rather than simply replicating existing content found in clinical systems, forms, messages or data sets. It is primarily focused on standardising current clinical knowledge and practice, aspiring to digitally represent all the things that clinicians and domain experts know and do as well as integrating relevant and sensible existing content. The resulting tension can sometimes be difficult to balance – current content vs anticipating future ‘best practice’ - this is the ‘art’ of clinical modelling. All published archetypes and those currently under review have a design intent of inclusivity of all relevant data points, always aiming towards (even if never achieving) a maximal data set and universal use case.

Any draft archetype in a project is a potential candidate for publication and reuse, otherwise it is rejected or kept separate in an incubator. @siljelb and I share that philosophy and protect the CKM library quite fiercely to establish its credibility as a high-quality resource. It's not perfect but an evolving work in progress. We meet weekly to discuss issues and actively manage the content.

2.       The Nasjonal IKT CKM mirrors the great majority of archetypes in the International CKM but local Norwegian governance ensures the representation of all archetypes in Norwegian Bokmål and inclusion of archetypes to support local requirements.
The Norwegian modellers work in parallel with the International CKM modellers, running synchronised archetype reviews and publishing/updating archetypes simultaneously. The majority of the archetypes are identical to the archetypes in the International CKM.

3.       The HiGHmed CKM references many of the International CKM archetypes, that is, it makes the international archetypes available in their archetype library as read-only. HiGHmed modellers actively contribute, and keep up-to-date, German translations to the International CKM. In this way, HiGHmed modellers have easy access to the International CKM archetypes in German. The HiGHmed governance is focused on the coordination of the modelling effort within the HiGHmed consortium, with processes that appear to mirror much of the international/Norwegian approach. Identification of HiGHmed-created archetypes that are candidates for inclusion in the International CKM has been limited by a lack of openEHR resources, especially the need for translation from German.

4.       The Apperta CKM also references (as read-only) many, if not most, of the International CKM archetypes. It does not appear to have a documented governance philosophy or approach but the content design and governance approach of the Apperta archetypes appear to reflect an alternative philosophy where modelling is often closely aligned to existing content and directly mirroring organisational, regional or national UK requirements, rather than aiming towards international interoperability.
To date, only 30 archetypes from amongst the 842 UK archetypes in Projects have been referenced back (as read-only) to the International CKM, and of these 30, almost all of them are scores or scales, for which there is usually little debate about clinical content or divergence in the modelling approach.
The Apperta CKM has only 7 archetypes in incubators, which implies that there is quite a different approach to the use of Projects and little use of Incubators as a ‘sandpit’ space for immature archetypes.

5.       The Slovenian CKM is a bit of an enigma and probably best not to use as a resource. It went live in 2013, has 37 registered users. In December 2020, 10 archetypes were added, to support COVID work, and prior to that the most recent changes appear to have occurred in early 2018. My understanding is that these were the archetypes that were used in the first implementation of the Better EHR around 2013.

(If any of this information about the different CKMs is inaccurate, please let me know.)

In addition, there is a Chinese archetype library, the Healthcare Modelling Collaboration, and I believe there is also one in Chile, containing .json ‘archetypes’.

 

In reality, anyone can build an archetype for any purpose. But is it a good one? It depends on your intent. At one end of the spectrum, the content of an archetype can be really rough, quick and dirty but if it is only used in your system then it really doesn’t matter. On the other hand, if you want to design an archetype for use within the coherent ecosystem, especially where you need broad interoperability, you need to understand how to design the content of that archetypes to optimise the potential for reuse and semantic interoperability. Considerations include a choice of class, the scope and focus of the content, the underlying modelling pattern, and how to document it clearly.

In practice, we have archetypes in the wild that are at all positions on that spectrum. That is fine, as long as we understand the consequences of our design choice. Designing for local use limits future interoperability; designing for maximal reuse can take more time to investigate and document.  However, one thing that you can be sure of, if you use an archetype that is either a draft or has not been designed with interoperability as the goal, then there is a real risk of building up technical debt and effectively you are contributing to the data silo problem again. Simply using an openEHR archetype in a clinical system does not provide semantic interoperability ‘out of the box’; using shared and published international archetypes gives you the best opportunity to achieve degrees of interoperability and break down the data silos.

Achievements of the openEHR Clinical Modelling Program

Now for a blog version of my Twitter thread celebrating the achievements of the international openEHR Clinical Modelling Program, its' Editors, & its' community of volunteer reviewers. I'm so proud of these people, these models. Together we've achieved something truly unique & groundbreaking 🌟🌟🌟🌟🌟

1. The archetype design methodology - a strategic and coordinated approach to data design that proactively deconstructs clinical knowledge & applies scientific rigour and repeatable clinical recording patterns to clinical information model development

2. The openEHR Clinical Knowledge Manager (CKM) tool - our secret weapon! This custom-built unique online tool is the coordinating centre for the Clinical Modelling Program - our library of archetypes, collaboration portal, and governance hub rolled into one.

3. Our archetype library is the most advanced and coherent collection of multilingual clinical information models available in the public domain.

4. The clinical knowledge governance methodology is unique, comprehensive and sophisticated, embedded into the CKM. Where else can you witness the innovation of parallel clinical information model content publication processes integrated with technical versioning?

5. We crowdsource the quality of our archetypes! The CKM has integrated an asynchronous, open & transparent peer-review approach to quality assurance of the archetype content so that clinicians & domain experts verify the content as ‘fit for use’ in clinical systems.

6. Clinician engagement in health data standards has been encouraged by reducing the technical/tooling barriers to enable grassroots clinicians to participate in archetype design and review.

7. We have built a spectacular CKM community, all by word of mouth and peer-to-peer recommendation.

- 2666 registered users from 104 countries, including 1017 volunteer reviewers.

- 300 registered translators and archetypes translated into 31 languages.

8. And within that CKM community:

  • 33% identify as health informaticians

  • 10.4% as medical practitioners

  • 9% as students

  • 5.8% as 'other'!

  • 5.3% as software engineers

  • 4.3% as administrators

  • 3.8% as nurses

  • 3.6% as researchers

  • 2.6% as consumers

  • 2.2% as academics

9. Demonstration of up to 100% archetype reuse across various, multilingual clinical scenarios in the earliest days of the COVID-19 pandemic – see "openEHR Archetype Use and Reuse Within Multilingual Clinical Data Sets: Case Study".

10. Identification of common, reusable modelling patterns in clinical recording eg the fractal nature of physical examination findings for different clinicians at varying levels of detail; tobacco, alcohol, substance use summaries.

11. Coordinating international publication of archetyped content for safety-critical, core or advanced clinical concepts where it is difficult to achieve consensus eg Adverse Reaction Risk in 2016 (incl the FHIR community); Advance care directive for patients & Advance intervention decisions for clinicians.

12. Our openEHR International archetype library underpins eHealth programs in Norway, Slovenia, England, Wales, Scotland, Alberta (CA) & Catalonia; EHRs for the City of Moscow, the Chinese Military & COVID CDS deployed in Wuhan. It also underpins an evolving national primary care data dictionary in AU.

13. And finally, if you're in the mood for some light reading, our Zotero library folder focused on #openEHR clinical modelling.

What have I missed?

The state of openEHR Clinical Modelling Program

Continuing from openEHR Clinical Modelling Program - the early days…

The situation changed significantly in 2014 when the Norwegian eHealth program acquired their own CKM. From my point of view, this marked a singular turning point in the destiny of the Clinical Modelling Programme.

The Norwegian lead, Silje Ljosland Bakke, joined the Clinical Modelling Program as my co-lead, and she recruited a small team of modellers. Between 2014 and 2017 we ran seven two-day introductory clinical modelling courses and eight advanced modelling workshops. Since 2018, the Norwegian team have run additional training workshops independently. They invested significantly in training clinicians, vendors, and decision-makers about openEHR and established their national governance processes.

In addition, the Norwegian program has invested strategically in building capacity in their national modelling team in openEHR and in training their reviewers. They are a paid organisational member of openEHR, support Silje as a CIC Board member and International CKM Clinical Knowledge Administrator and license and run their own CKM as a national resource. Their modelling team currently comprises 3 experienced members, participating since 2014, and 3 newer members who are rapidly growing in skills. Since 2014 I have met with them weekly to discuss modelling issues, initially in a mentoring role, increasingly in recent years this has been focused on joint and parallel archetype development and reviews.

Overall, during the period 2006 to 2019, I delivered more than 30 2-day openEHR clinical modelling introduction courses in Australia, UK, multiple EU countries, US, Canada, Brazil, China, Japan. In addition, I’ve run many 3-5 day advanced modelling workshops in various destinations over the years. Ian McNicoll attended his first openEHR course in 2007 and was frequently a co-lead from 2009. He has been just as active independently since he left Ocean in the early 2010s.

Very pleasingly, since 2018, the Norwegian team have felt confident to run their own training workshops independently. This was another critical moment, when we could demonstrate that the openEHR approach was transferrable. Our biggest challenge now is to make it scalable.

Between March 2018 and August 2021, the openEHR CIC engaged me on a paid consulting basis for 25 hours per month, continuing my role as Clinical Program Lead. To the best of my knowledge and in that context, the cost to the openEHR CIC and community to achieve the progress outlined in State of the CKM – 2021 has been to pay me for just under 6 hours per week for a period of 41 months. Most of those 6 hours per week has been used to maintain the CKM and support the modelling community – weekly CKA meetings, managing change requests and translations, answering questions from the community, meeting with community partners, training and mentoring new editors, etc.

So, what most people may not be aware of is that by far the majority of archetype publication progress in the International CKM has mostly been driven by an extremely close, deliberate, and strategic weekly collaboration between myself and the Norwegian modelling team. In fact, I’d estimate that >90% of the archetype publication, especially at the accelerated rate of the past 2 years, has been entirely resourced by the Norwegian modelling team – including my consulting time. While this arrangement has worked well to date, largely because the Norwegian priorities for archetype publication have closely mirrored those for the international modelling community, it is clearly not sustainable.

Let me be perfectly clear, if the Norwegian program is reduced or withdrawn, the openEHR modelling program will effectively come to a standstill. And in my opinion, there are only three individuals who are currently skilled enough to design archetypes for, protect the integrity of, maintain, and govern the International CKM – and they all have full-time jobs and live in Norway.

openEHR’s greatest asset is also its largest vulnerability. As the community, the implementations, the contracts and the number of models has grown, the capacity for modelling archetypes fit for the International CKM and training, then mentoring, modellers so that they can become independent Editors and ultimately Clinical Knowledge Administrators, has been ignored. In the first instance because we’ve essentially been in survival mode, and struggling to establish and maintain what we already had.

We have failed to approach the Clinical Modelling Program strategically and ensure that we have increased workforce capacity to support the increased openEHR activity.

Now that I have unfortunately been forced to withdraw my services, unfortunately this leaves Silje to manage the responsibility of the Modelling Program in isolation.

Yes, theoretically CKAs from other CKMs could step in. But could they, should they? If you take a look at the other CKMs you will note that they have different focuses, different content (to be discussed in another post).

There is no succession plan, no redundancy, no Plan B. The future of the Clinical Modelling Program is being made up on the fly. The community should be concerned.

After all, if the Clinical Modelling Program fails or folds, what of the rest of the organisation? If the quality and philosophy of the CKM library is not maintained and protected due to lack of skilled operators, what is the consequence for implementations?

openEHR Clinical Modelling Program - the early days

The openEHR Clinical Modelling Program commenced life as the Archetype Editorial Group and ‘operated’ between 2007 and 2012-ish. The original announcement in 2007 described it as the lead group for archetype authoring. Comprising a group of doctors influential in health IT and friendly to the openEHR approach selected by Sam Heard (Ocean, AU) in the first instance, the announcement also states the intent to develop a nursing group would be convened soon after.

Members that I can recall included Sam Heard, Sergio Carmona (Chile), Beatriz De Faria Leao (Brazil), Sundaresan Jagannathan (Jag) and Ian McNicoll (both from Scotland), Omer Hotomaroglu (Turkey, who went on to be the primary author for the ECG archetype) and Evelyn Hovenga (Australia, and despite being a nurse). Sam Heard gave me the title of ‘Convenor’, if I remember rightly, although it was never clear to me what the function of the group was, and I didn’t convene much. Effectively we had an oversight group without a clear purpose. I’d email them an archetype with some questions and, usually, no one responded. That wasn’t unreasonable in retrospect – if you haven’t any reason to be interested in the content of an archetype, then why would you spend time out of your busy day?

My main takeaway from this period was that expecting a committee of experts to provide editorial feedback about something that wasn’t relevant to their work or needs, especially without providing a framework for discussion was never going to work. We had to work smarter and be more focused on what we needed to achieve. This heavily informed the initial approach to clinician engagement and governance of CKM.

In 2007, an academic paper on the earliest thinking about clinical knowledge governance and describing the CKM precursor, the online ‘Archetype Finder’, co-authored by Sebastian Garde, Evelyn Hovenga and Sam Heard et al [1].

Sam Heard showed me some of his first archetypes in 2004 when I first joined Ocean - Adverse reaction and Blood pressure, if I remember rightly. But 2008 was the year that the first serious modelling work was done as part of an evaluation project for the NHS England’s infamous NPFIT program. Sam Heard and I worked in London for a number of months producing the first serious tranche of archetypes to support 2 use cases - the top 10 presentations to the Emergency department and archetypes to support antenatal care from a first visit through to a postnatal consultation. It was during this period that we realised that we needed the CLUSTER class of archetypes - they didn’t exist in the original specs. I still have those archetypes in an archive - interesting to see how our modelling thinking has evolved.

The first iteration of CKM development was developed during 2007/2008 - coded by Sebastian Garde, me as Product Manager, and with the first archetype uploaded around July 2008. For the next 10 years Sebastian and I battled awkward time zones to meet regularly, usually twice weekly via Skype, to plan, discuss, revise. Sebastian would code while I slept and vice versa. Ian McNicoll contributed regularly during the period when he was employed by Ocean.

Sam’s initial theory of developing groups with semi-autonomous, independent authoring and editorial responsibility for a content domain or speciality was attractive in theory, but the experience of the Editorial Group made it clear that this was not very practical. In response, the structure of the CKM was designed to support a folder-like structure – at the subdomain level as well as governed projects and ungoverned incubators to facilitate all kinds of groups with roles and responsibilities, and at various levels of granularity. This has worked quite well in practice - and is used extensively in the International CKM. Any work in projects is governed tightly by Clinical Knowledge Administrators, as these archetypes need to conform to the intent of a coherent ecosystem of archetypes, avoiding semantic overlaps and minimising gaps between concepts, always aspiring towards the ideal design each archetyped clinical concept being inclusive of any/all relevant data points and for any/all relevant use cases.

I have previously written about the State of the CKM in 2010.

From left Michael Beale (Ocean, UK), Rong Chen (Cambio, Sweden), Dipak Kalra and David Ingram (UCL, London), Ian McNicoll, Adriana Danilakova (Ocean, UK), Shinji Kobayashi (Kyoto University, Japan), Joana Feijó (Critical, Portugal), Seref Arikan (Ocean, UK), Jussara Macedo Rötzsch (Brazil), Sam Heard and myself (Ocean, AU). Photo credit: Shinji Kobayashi.

During an extended Board meeting held in London in September 2012, Martin Severs (not in the photo), the man who had recently coordinated the transformation of SNOMED into its new organisation, joined the meeting as a guest and he identified the Clinical Modelling Program as the single most critical success factor for openEHR. Everyone agreed that the programme should receive priority for funding from the Board.

At that point, at Martin’s request, I developed a proposed cost for a paid CKA at one day per week, just enough to kickstart the transformation of the CKM and modelling program from a special interest group towards a more formal and strategic approach. But no funding was able to be made available and unfortunately, this was the first and last meeting held about the strategy for the modelling program, at least to my knowledge.

From day one the Program has evolved, somewhat organically and based hugely on goodwill and a shared vision. We made do, growing and promoting the modelling approach the best we could with almost zero resources available from the fledgling Foundation. Ocean developed the CKM and provided it to the openEHR community for free, as well as covering my time and Sebastian’s. Others volunteered their time and effort, or their time was covered by their employers.

In building up and growing the Clinical Modelling program in the early days, I couldn’t find any examples of similar work to leverage - not on clinical modelling with the intent of building a coherent domain for the whole of health, nor associated clinical knowledge governance. We seemed to be in uncharted territory, armed with little more than the earliest Archetype Editor tool, an unstable flaky Template Designer, a fledgling CKM and a lot of enthusiasm.

If anyone has any additions or corrections, I’m happy to include or amend…

Next… the state of the Clinical Modelling Program

[1] Garde, Sebastian & Hovenga, Evelyn & Gränz, Jana & Foozonkhah, Shahla & Heard, Sam. (2007). Managing Archetypes for Sustainable and Semantically Interoperable Electronic Health Records. eJHI - electronic Journal of Health Informatics. 2. e3.

State of the openEHR CKM - 2021

As I leave my leadership role in the Clinical Modelling Program, let me start by sharing with you some facts and insights…
As of 2 November 2021, from CKM statistics:

Clinical modelling community

All insights into the clinical modelling community is represented by those registered in CKM.

  • 2663 registered users from 104 countries.

  • 1015 individuals have volunteered to participate in archetype reviews - that’s 38% of the total number of registrants. This is the pool of people who we can draw on to invite to an archetype review. It does not represent whether they have been invited, nor if they have responded to an invitation.

  • 300 (11%) have volunteered skills in translation.

Active archetype statistics, projects only

It’s been difficult to get a consistent handle on these as CKM has some inconsistencies in calculations but the trends are sound.

  • All active local archetypes, projects only – ~519

    • Draft – ~365

    • In review – 30, counted (6% of 519)

    • Published – 139, counted (27% of 519)

    • Review suspended – 7

    • Reassess – 5

Data point statistics

·         All active archetypes, projects only - 5915

·         Published archetypes - 1478 (25%)

Language statistics

  • Number of languages - 31

  • Top 5 languages

    • Norwegian Bokmål – 239

    • German – 206

    • Portuguese (Brazil) – 151

    • Swedish – 112

    • Arabic (Syria) - 78

Roles

  • Clinical Knowledge Administrators – 2

  • Editors

    • Archetype content

      • Regular - 5

      • Guest Editors on a special interest or per project basis -~15 have had varying levels of training/mentoring

    • Translation – 20+

Compare this with ‘State of the CKM’ in 2019

  • 2343 registered users from 96 countries   

    • 857 reviewers

    • 281 translators

  • 478 archetypes

    • 92 published (11%)

And just for reminiscing about the good old days – ‘State of the CKM’ in 2010.

Archetype numbers -Analysis and discussion

The Clinical Modelling Report presented at the recent 2021 AGM represented more about the dynamic nature of activity in the 12 months to August that is not evident from the stats above:

  • 73 newly created archetypes – mostly by the Editorial team or via CKM proposals

  • 155 archetypes modified/corrected/refined

  • 30 archetypes newly published or republished

  • 31 archetypes have undergone 47 review rounds due to 77 unique reviewers contributing 468 reviews (an average of 6 reviews per reviewer)

  • The top reviewer completed 39 reviews.

I think most people will agree that this reflects a dynamic and active Editorial and reviewer community participating in the CKM hub.

BUT let’s do a quick reality check…

The first archetype was uploaded in mid-2008.

In 13 years, we have published 139 archetypes – that’s an average of only 10.7 archetypes per year.

In the past 2 years, we have had a net gain of 41 archetypes over the past 2 years – mainly acquired through proposals, the COVID collaboration and projects such as the Genomics work program. Many old patterns or concepts were retired. The CKM has undergone quite a big clean-up to ensure it reflects the evolving modelling patterns, always aiming to create a coherent ecosystem of models.

In that same timeframe, the number of archetypes published has increased by 47, and the corresponding percentage rose from 11% to ~27% - that’s an average of 23.7 archetypes per year. This sounds positive, but is it really? Is this publication rate enough? What numbers should we be aiming for?

In the past, I’ve estimated that if we design archetypes well, 50 core archetypes would support most of a primary care EHR, maybe 2000-3000 to support all the clinical requirements for a hospital EHR. These estimates are probably still relevant. Although as we start to explore standardisation of secondary data sets that can be abstracted from the original EHR records – for purposes such as research, registries, and reporting – numbers will blow out even further.

Let’s use 2500 as a working number for the required number of archetypes to support an EHR.

At historical average rates, it will take us 233.6 years to publish the number of archetypes that we need. At rates from the past 2 years, it will take us 105 years. That’s clearly not realistic or sustainable. And if we add in archetypes for standardising secondary use, reporting, research etc, this balloons further.

What about the 365 draft archetypes that we already have? At historical rates = 35 years; at recent rates, 15 years.

Let me be perfectly clear here, in my opinion openEHR has the potential for becoming the ‘universal health language’, a lingua franca for health IT.

In order to transform digital health we need a common information model, and the best candidate we have to achieve this is with openEHR… This is what I’ve been working towards for over 15 years - a common domain information model supported by a coherent set of archetypes as the foundational clinical models.

But the reality is severely lagging, held back by a Board that has been absent and uninterested.

____________________

At the AGM, the CIC Board has proposed ‘refreshing’ and ‘rethinking’ the Clinical Modelling Program, apparently by going to vendors to request more models…

We have more archetypes than we can cope with at the moment. While gathering more archetypes will help to fill the content gaps, the rate-limiting step is actually the review and publication process. And this has been ignored for more than a decade.

The Board doesn’t need to ‘rethink’ the Clinical Modelling Program. It does need to stop ignoring it and start supporting it.

At the simplest level, it needs:

  • to understand the work of the Clinical Modelling Program (It thinks it does, but it doesn’t)

  • to understand the skills required to manage a Clinical Modelling Program that builds archetypes to support a coherent data ecosystem (No, despite the rhetoric, it absolutely doesn’t)

  • to develop a joint strategy with the CKAs who know how to protect the quality, integrity and credibility of the international CKM as the ‘source of truth’ for openEHR archetypes;

  • to identify and source adequate funding to:

    • train and upskill Editors and Clinical Knowledge Administrators to ensure that the current asset is independent and sustainable

    • ensure that the CKM can continue to function as an independent entity that underpins all openEHR implementations

  • a succession plan

The Clinical Modelling Program has effectively operated as an orphan within the organisation. It is more by luck than strategy or design that we have achieved what we have. This needs to change or openEHR could fail.

This is the kind of thing I wanted to speak to the Board about each time I approached it this year. Each time my request was rejected, with the reason being that Silje Ljosland Bakke had been appointed the Clinical Modelling Program representative on the Board at some point. Silje (already on the Board as an organisational rep) has repeatedly denied that she fulfils this role. So what on earth is going on. Certainly, the appointment of a Board representative has never been discussed with me. Rather both Silje and I feel that the Modelling program could only be fairly represented if both co-leads were involved in any Board discussions or program strategy.

One has to wonder, is this a consensus position of the Board as a whole, or it is just the position of the Co-chair who responds to my emails, who hasn’t spoken to me once during my period of paid engagement, not to understand the Modelling Program, nor even to enquire why I withdrew my services.

It’s messy and ugly and totally unnecessary. And the openEHR community is the ultimate loser.

More to come…