Archetype publication question - implications for implementers

Hi everyone,

I’m seeking some community input around a conundrum that has arisen regarding archetype governance, or more specifically if we should offer a new version of an archetype that included breaking changes/corrections according to the openEHR specifications but which are not critical in terms of clinical safety – a bit of a grey zone, if you like. If clinical safety were implicated, the decision would be easy.

The Blood Pressure archetype was published in 2009 and I believe is in fairly wide use in systems at this point. Currently published version here, and which has had only ‘trivial’, non-breaking changes, including addition of translations, etc since publication.

Recently the Norwegian community translated the archetype and then undertook a local review of the archetype. They have suggested some modifications to the archetype which include updating some of the data elements around identifying the body location of the BP measurement to be in keeping with more recent archetype patterns that we have been using, plus identified that the representation of degrees of Tilt was not using the UCUM units, plus a few minor additions.

The result is that their new candidate archetype (here) which includes these changes is regarded as a Major revision under our current CKM versioning rules and if republished warrants becoming a version 2. That is all perfectly OK from an academic governance point of view.

There is no doubt that the archetype is a more accurate and enhanced iteration but the practical implications of republishing as a v2 are not trivial to implementers.

So I seek your advice on whether we should proceed with further content review with the intent of re-publishing as a new v2 archetype:

· Pros

o Archetype data is updated to include correct UCUM units

o Archetype data is updated to include more ‘modern’ modelling patterns that are being used increasingly in more recent archetypes

o New implementers will be able to use the most up-to-date version of the archetype, rather than using an archetype that has been identified as having flaws. Otherwise new implementers will continue to implement a known, flawed archetype into their new systems

· Cons

o Existing implementers will need to decide whether it is worthwhile to update to v2. The alternative is to stay with the v1 published archetype as is and consider updating at some future time.

o The update of the UCUM unit and body location pattern does not have major safety implications or significantly impact the modelling quality, yet will have internal implications in existing clinical systems.

o Two versions of the archetype will be in circulation, and implementers will need to manage the interoperability issues that will arise.

o Norway will likely use the new archetype as their national standard, diverging from the openEHR CKM content, which is not desired by either party.

A portion of the diff is attached, which demonstrates the major breaking changes. There are many other changes that only refer to translations and are non-breaking in the rest of the diff

This is the first time we have had to update a published archetype and it certainly won’t be the last. If there were breaking changes that needed to be made for clinical safety reasons or similar critical reasons I would have no hesitation in proceeding to v2. If there were non-breaking changes we would manage the progression with additional minor revisions or patches – not a problem. This one has breaking changes but no clinical safety issues, so a bit of a grey zone because of the possible implementation implications.

I have no doubt that many implementers are already grappling with these issues if they have implemented draft archetypes, so perhaps you all have established systems and approaches for this.

I have had some advice suggesting we should leave the archetype as is, rather than ‘rock the implementation boat’ for little semantic value, yet I’m not sure that it is our role to be paternalistic. My own inclinations are that we should govern the archetypes from a pure point of view, updating and creating new versions if we have to, and allowing CKM to provide the transparency that will support implementers to make informed choices.

So:

Option 1: Do nothing. The current flawed archetype will be the only one available on the openEHR CKM

Option 2: Promote the new candidate archetype to the public trunk as a potential new iteration – so available for viewing and download, but with no official status, effectively in limbo until a further review round is carried out and it is republished.

Option 3: Promote the new candidate archetype to the public trunk, run formal content reviews on it and plan to re-publish as v2

Please, your thoughts?

Regards

Heather

Dr Heather Leslie MBBS FRACGP FACHI
Consulting Lead, Ocean Informatics

Clinical Programme Lead, openEHR Foundation
p: +61 418 966 670 skype: heatherleslie twitter: @omowizard

(attachments)

2015 10 BP major diff.jpg

Hi everyone,

I’m seeking community input around a conundrum that has arisen regarding archetype governance or, more specifically, if we should offer a new version of an archetype that included breaking changes/corrections according to the openEHR specifications but which are not critical in terms of clinical safety – a bit of a grey zone, if you like. If clinical safety were implicated, the decision would be easy.

The Blood Pressure archetype was published in 2009 and I believe is in fairly wide use in systems at this point. Currently published version here, and which has had only ‘trivial’, non-breaking changes, including addition of translations, etc since publication.

Recently the Norwegian community translated the archetype and then undertook a local review of the archetype. They have suggested some modifications to the archetype which include updating some of the data elements around identifying the body location of the BP measurement to be in keeping with more recent archetype patterns that we have been using, plus identified that the representation of degrees of Tilt was not using the UCUM units, plus a few minor additions.

The result is that their new candidate archetype (here) which includes these changes is regarded as a Major revision under our current CKM versioning rules and if republished warrants becoming a version 2. That is all perfectly OK from an academic governance point of view.

There is no doubt that the archetype is a more accurate and enhanced iteration but the practical implications of republishing as a v2 are not trivial to implementers.

So I seek your advice on whether we should proceed with further content review with the intent of re-publishing as a new v2 archetype:

· Pros

o Archetype data is updated to include correct UCUM units

o Archetype data is updated to include more ‘modern’ modelling patterns that are being used increasingly in more recent archetypes

o New implementers will be able to use the most up-to-date version of the archetype, rather than using an archetype that has been identified as having flaws. Otherwise new implementers will continue to implement a known, flawed archetype into their new systems

o Further content review will expose the archetype to a broader range of clinicians and their input will potentially further enhance, or at least endorse the current, quality.

· Cons

o Further content review will possibly introduce further changes – maybe breaking, maybe not.

o Existing implementers will need to decide whether it is worthwhile to update to v2. The alternative is to stay with the v1 published archetype as is and consider updating at some future time.

o The update of the UCUM unit and body location pattern does not have major safety implications or significantly impact the modelling quality, yet will have internal implications in existing clinical systems.

o Two versions of the archetype will be in circulation, and implementers will need to manage the interoperability issues that will arise.

o Norway will likely use the new archetype as their national standard, diverging from the openEHR CKM content, which is not desired by either party.

A portion of the diff is attached, which demonstrates the major breaking changes. There are many other changes that only refer to translations and are non-breaking in the rest of the diff

Major changes are:

· Changing ‘Tilt’ units – ‘°’ to ‘deg’ – at1005 – this is the critical and breaking correction that has triggered considering these additional changes:

o Making Measurement Location a choice of coded text and text – at0014

o Removal the redundant ‘Location’ cluster heading

This is the first time we have had to update a published archetype and it certainly won’t be the last. If there were breaking changes that needed to be made for clinical safety reasons or similar critical reasons I would have no hesitation in proceeding to v2. If there were non-breaking changes we would manage the progression with additional minor revisions or patches – not a problem. This one has breaking changes but no clinical safety issues, so a bit of a grey zone because of the possible implementation implications.

I have no doubt that many implementers are already grappling with these issues if they have implemented draft archetypes, so perhaps you all have established systems and approaches for this.

I have had some advice suggesting we should leave the archetype as is, rather than ‘rock the implementation boat’ for little semantic value, yet I’m not sure that it is our role to be paternalistic. My own inclinations are that we should govern the archetypes from a pure point of view, updating and creating new versions if we have to, and allowing CKM to provide the transparency that will support implementers to make informed choices.

So:

Option 1: Do nothing. The current flawed archetype will be the only one available on the openEHR CKM

Option 2: Promote the new candidate archetype to the public trunk as a potential new iteration – so available for viewing and download, but with no official status, effectively in limbo until a further review round is carried out and it is republished.

Option 3: Promote the new candidate archetype to the public trunk, run formal content reviews on it and plan to re-publish as v2

Please, your thoughts?

Regards

Heather

Dr Heather Leslie MBBS FRACGP FACHI
Consulting Lead, Ocean Informatics

Clinical Programme Lead, openEHR Foundation
p: +61 418 966 670 skype: heatherleslie twitter: @omowizard

Hi Heather,

Instead of removing the incorrect UCUM unit and the old modelling patterns completely, would it be possible to mark these bits as ‘deprecated’ in some [informal] way in the ontology?

This way you could make the desired changes and republish as a minor revision of version 1.
For a version 2 archetype, the bits marked as deprecated would be removed (this v2 archetype could be provided as a draft now or later).

Cheers
Sebastian

P.S.: Arguably, a more formal way of deprecating bits and pieces in an archetype, will become quite useful in the future.

Personally I don’t see the reason to not just update the version. If the archetype contains breaking changes it is a v2. I would enforce this even for drafts, as I have stated before.

I have also seen lately changes in archetype ids. I would expect that the old archetype with the old id was kept with a deprecated lifecycle status.

Regards

Hi everyone,

I’m seeking some community input around a conundrum that has arisen regarding archetype governance, or more specifically if we should offer a new version of an archetype that included breaking changes/corrections according to the openEHR specifications but which are not critical in terms of clinical safety – a bit of a grey zone, if you like. If clinical safety were implicated, the decision would be easy.

The Blood Pressure archetype was published in 2009 and I believe is in fairly wide use in systems at this point. Currently published version here, and which has had only ‘trivial’, non-breaking changes, including addition of translations, etc since publication.

Recently the Norwegian community translated the archetype and then undertook a local review of the archetype. They have suggested some modifications to the archetype which include updating some of the data elements around identifying the body location of the BP measurement to be in keeping with more recent archetype patterns that we have been using, plus identified that the representation of degrees of Tilt was not using the UCUM units, plus a few minor additions.

The result is that their new candidate archetype (here) which includes these changes is regarded as a Major revision under our current CKM versioning rules and if republished warrants becoming a version 2. That is all perfectly OK from an academic governance point of view.

There is no doubt that the archetype is a more accurate and enhanced iteration but the practical implications of republishing as a v2 are not trivial to implementers.

So I seek your advice on whether we should proceed with further content review with the intent of re-publishing as a new v2 archetype:

· Pros

o Archetype data is updated to include correct UCUM units

o Archetype data is updated to include more ‘modern’ modelling patterns that are being used increasingly in more recent archetypes

o New implementers will be able to use the most up-to-date version of the archetype, rather than using an archetype that has been identified as having flaws. Otherwise new implementers will continue to implement a known, flawed archetype into their new systems

· Cons

o Existing implementers will need to decide whether it is worthwhile to update to v2. The alternative is to stay with the v1 published archetype as is and consider updating at some future time.

o The update of the UCUM unit and body location pattern does not have major safety implications or significantly impact the modelling quality, yet will have internal implications in existing clinical systems.

o Two versions of the archetype will be in circulation, and implementers will need to manage the interoperability issues that will arise.

o Norway will likely use the new archetype as their national standard, diverging from the openEHR CKM content, which is not desired by either party.

A portion of the diff is attached, which demonstrates the major breaking changes. There are many other changes that only refer to translations and are non-breaking in the rest of the diff

This is the first time we have had to update a published archetype and it certainly won’t be the last. If there were breaking changes that needed to be made for clinical safety reasons or similar critical reasons I would have no hesitation in proceeding to v2. If there were non-breaking changes we would manage the progression with additional minor revisions or patches – not a problem. This one has breaking changes but no clinical safety issues, so a bit of a grey zone because of the possible implementation implications.

I have no doubt that many implementers are already grappling with these issues if they have implemented draft archetypes, so perhaps you all have established systems and approaches for this.

I have had some advice suggesting we should leave the archetype as is, rather than ‘rock the implementation boat’ for little semantic value, yet I’m not sure that it is our role to be paternalistic. My own inclinations are that we should govern the archetypes from a pure point of view, updating and creating new versions if we have to, and allowing CKM to provide the transparency that will support implementers to make informed choices.

So:

Option 1: Do nothing. The current flawed archetype will be the only one available on the openEHR CKM

Option 2: Promote the new candidate archetype to the public trunk as a potential new iteration – so available for viewing and download, but with no official status, effectively in limbo until a further review round is carried out and it is republished.

Option 3: Promote the new candidate archetype to the public trunk, run formal content reviews on it and plan to re-publish as v2

Please, your thoughts?

Regards

Heather

Dr Heather Leslie MBBS FRACGP FACHI
Consulting Lead, Ocean Informatics

Clinical Programme Lead, openEHR Foundation
p: +61 418 966 670 skype: heatherleslie twitter: @omowizard

Would they be alternatives of the data type or just new elements at the same level? I see problems with both: if you create an alternative on data types probably you won’t be able to add bindings to it, and if made a another element then you don’t have an easy way of telling what corrects (you could even have corrections of corrections of corrections… Which one would you link to?). Probably even assertions should be included in order to avoid the inclusion of the deprecated and the corrected one in the same instance.

IMHO is much easier to just upgrade the version

Hello,

If the archetype introduces incompatible changes with the existing version, then no discussion it is possible: a new v2 has to be published after the proper review rounds. Then the question is what happens to v1. Being purist, v1 should be marked as obsolete (still usable at your own risk) and v2 be the recommended one for new implementations. It is the simpler and safest way to act in order to maintain a controlled repository of archetypes. If implementers have adopted an archetype methodology, they they have to accept that changes to archetypes will happen.

It is also true that many software projects maintain several branches of development simultaneously (i.e Tomcat 6, 7 and 8). Is this also applicable to archetypes? Can we maintain v1 and v2 both as published archetypes? Certainly we agree on defining such rules of governance. But we should ask ourselves some questions: Are both versions just alternative representations of the same clinical model? Should the community prioritize one over the other? Or maybe they are representing different models that should be named differently to avoid confusions? Or maybe v1 can become just a kind of template of v2?

The answer to these questions will depend on each use case, but the important thing is that we act consistently in all cases.

David

My opinion is that when a new archetype-version is incompatible with the previous, it should not have the same name.

In case of compatibility it is save to use wildcards for versions in slots, in case of incompatibility, this can cause problems in queries

Bert

we can - that’s the reason for having the major version included the ‘interface id’ of the archetype - all vN of the same root archetype can co-exist. - thomas

Hi Heather, I would go for option 3:

’ Option 3: Promote the new candidate archetype to the public trunk, run formal content reviews on it and plan to re-publish as v2’

This way ‘old’ implementations can keep referencing V1 and new implementations can start using V2 or stick to V1 depending on their needs. I think that even the evolution of both versions should be a possibility in the future (although avoided if not completely necessary).

Regards,

Luis

I was specifically pointing to the relationship between version numbers and
lifecycle state. Of course we can have several versions published at the
same time. And nowhere in the Archetype Identification specification (
http://openehr.org/releases/AM/latest/docs/Identification/Identification.html)
implies that a new published version automatically makes a previous version
obsolete. The question was if that kind of rule should exist or if users
will naturally tend to adopt always the newest version if there are several
available.

In my opinion that should not be a fixed rule (in some cases both versions
could coexist as published), but the community should try to avoid that
situation and always push for the latest version.

From a governance point of view, I believe it is clear that the v2 route is the cleanest option here.
And in a general way I also agree with your concerns, Diego!
I think that my suggestion of deprecating old and adding the new elements, can only make sense if we can model the new elements in a v1 archetype in a way that the data paths don’t need to change when later migrating to a forthcoming v2 archetype.

From an implementers point of view I am not so sure I’d be so happy if I need to take the archetype to the next major version just because of this. Therefore, I also agree with Heather and share the concerns that creating a v2 in this case is a bit over the top.
Not sure if anybody is even using Tilt or the location from this archetype’s protocol in the first place?

If you are able to add the new things (or at least the unit change) to the v1 archetype and start the work on publishing a “clean” v2 archetype at the same time, this would allow implementers to upgrade in their own time, while being able to enable the use of correct units and ‘modern’ modelling patterns in the existing v1 archetype.

I think it is reasonable to add another unit to an archetype without having to up its major version (and provide some guidance that this is the ‘better’ unit to use).
Changing the modelling pattern for the location and adding this a complete alternative may be asking to much from a minor revision of an archetype.

Maybe this is also a good exercise for anybody using this archetype on how best to upgrade from one major version to the next…but my preference I think is to, yes start with a v2 archetype, but also add the correct unit to the v1 archetype and republish as a minor revision.

Sebastian

Hi all,

This is IMO, a very important issue for the openEHR community and many thanks to Heather for providing such a clear exposition of the issues and choices, faced by any community building products and tools based on open-source distribution and governance principles. As such, I do not think these challenges are unique to openEHR.

It is particularly important for vendors and implementers, who as well as trying build great systems are also building an ecosystem, one of whose strengths and sales-points is the ability to use ‘shared components’ out-of-the-box.

openEHR is well -engineered to support controlled change to new versions of artefacts and there is no question that we will regularly have to make such changes, even breaking changes as new clinical safety issues or new requirements emerge. One can perhaps see this as ‘market-driven’ change - suppliers will say - “we need a new data point”, or “the V1 archetype is no longer fit-for-purpose, we accept the need for a V2 and will manage the upgrade process”.

The example Heather has given around the Blood pressure archetype is a good example of what we might call ‘modeller-driven/best practice change’. Some perfectly reasonable issues have been detected in the V1 BP archetype, and ‘best modelling practice/ best semantics’ would suggest that we create a V2. However, I doubt if there is any real demand for this from the vendor community .. very few will be using the Tilt element which contains the error and the other issue is more about modelling style- what is there at the moment works ok.

So, in reality, I suspect there are very few drivers to push implementers to use V2, and we will end up (for now) with a ‘best-practice’ V2 and a V1 that continues to be used by the vast majority of implementations. One can argue that this is how the system is supposed to work .. put the variations out there and let the market decide, but new entrants to that market, and existing vendors working in multiple national markets will find that they are being asked to develop against both V1 and V2.

Again, no-one disputes that this will happen for perfectly good reasons where V2 solves some real problems for implementers but I am anxious that we do not create unnecessary market confusion, purely to fix some rather obscure, if real problems.

Heather quite reasonably asks the question ‘Is it the role of the international modelling team to take such issues into consideration, or should the CKM efforts be purely driven by quality and technical correctness’.

I think it is very important that we get feedback from Industry on this. Please give us your input.

Ian

Dear all,

I agree with Ian that any change at international level should be market driven. From an experience of someone who works with standardization for years and who already led the adoption of standards in Brazil’s extensive market, it is worth remembering that standards must reflect a consensus among the various stakeholders. Not always the final agreement reflects the most purist academic point, on the contrary they reflect a sum of needs and more pragmatic issues. It is the old saying: perfect is enemy of good.

From that experience, I must say there is always has someone challenging the standard adopted, by always, saying that this or that attribute is missing or could be represented differently. I always reply, that if we pursue perfection it wll be a never ending discussion and we will never adopt anyhting. Changes must have a value to aggregate to every user to be done. openEHR is still taking baby steps in several countries and we, the adoption"s supporters, use precisely the archetype “blood pressure” as a flagship demonstration of green archetypes worldwide, it is iconic . A change to v2 now, in my opinion gives a confusing message from us for those who are starting to adopt openEHR.

IMO is strongly reccomended that Norway adopts BP v2 as the national archetype first(I wonder if it is consensus within that country). Later the community can evaluate their experience and change it with more evidence and support of the international community of users.

Regards

Hi

I’ve not been involved in the revision of the Norwegian Blood pressure archetype, so I do not posess any ownership of the changes proposed. They can be looked upon as minor, but still they have arised after a review. I know personally several of the reviewers, and can assure they are very competent clinicians. In that perspective, I’m not happy about some of the comments below. Like “Who’s using Tilt anyway” and suggestions of the Norwegian community to create obscure problems.

  1. Using Tilt: Oslo university hospital is close to implement DIPS Arena with the BP archetype. Fairly soon there will be departements that will use Tilt. If Tilt was an element not necessary, why is it there in the first place? It might not be important for most users, but I have a remembrance of Maximum Data Sets.

  2. Obscure problems: Why should not the correct unit be available to the users?

  3. Blood pressure as a iconic flag ship: Wouldn’t it be great to show the world that openEHR is able to update even the “dear baby archetype” when it is needed? Even our dearest babies grow up.

Outside our small community, there are a great skepticism towards how openEHR will solve versioning of archetypes. It’s important that we will not be ruled by impractical thoughts like “not invented here”, and “doesn’t matter for the major part of us”.

Regards

Vebjørn Arntzen

Enterprise architect, ICT-dept, Oslo universitetssykehus HF

Tlf +47 4143 7589

Hi all,

As long as someone in the world performs medical research, our knowledge about medicine will increase and change. This imply that changes in our information models and ontologies due to new knowledge (and pervious errors) are something constant and something every implementer needs to plan for. I therefore think that openEHR needs to make it as easy as possible for the implementers to implement updates to the archetypes in their systems, but also communicate that archetypes will change regularly and that is something the implementers need to live with.

To give some perspective, I can mention that during the first releases of SNOMED CT, the mechanism for versioning in the release format was quite simple and probably not enough helpful for the implementers to manage the regular updates. Quite large resources were therefore spent on creating a new release format, which is more helpful for implementers when handling updates in SNOMED CT, and switch from the old release format (called Release Format 1) to the new release format (called Release Format 2). The SNOMED CT license also require all implementers to regularly update to new versions of SNOMED CT.

Regards

Mikael

Hi Vebjørn,

I hope I did not give the impression that I was in any way suggesting that the Norwegian clinical reviewers were being obscure or unreasonable and causing problems, or that tilt is not used in some applications. The review team have done exactly what we ask of them - to point out issues and errors and the ‘iconic’ status of BP does not give it any special privileges :).

Just so that people understand this issue - the potentially breaking change in the BP archetype is that the unit of measure for the angle of Tilt is defined a degree symbol = °
which is the printable version of the UCUM unit and not the official UCUM unit which is = DEG or deg.

If the Oslo University Arena implementation was perhaps 10 years down the track, with perhaps hundreds of thousands of BP records, including a small proportion with Tilt measurements using the ° unit already captured, it would be interesting to consider whether the cost of correcting this issue was felt to be worthwhile or whether we could ‘live with’ using the older version.

@Mikael - the capacity to re-version and version is now quite capably built into openEHR (and we learnt quite a bit from SNOMED CT experience with namespacing). This is really not a technical question and it is always assumed that new archetypes ,new revisions and new versions (breaking) will always be required and supported.

The question for us as modellers is whether we should take any account of the potential downsides of forking an archetype on implementers in our publication process or whether we should at least ask ourselves whether the overall benefits outweigh the potential disadvantages.

As I said, I don’t think this is unique to openEHR, it will apply to any formalism which has constraints or dependencies which over time need to be adjusted.

Ian

Hi Ian,

I should probably clarify that the versioning mechanism in SNOMED CT is more than a technical thing. The versioning mechanism also includes guidelines about how to handle the changes in the receiving system. However, the guidelines are distributes in a form that is machine (and human) readable and processable, which might at a first look seem just to be a technical thing.

Regards

Mikael

Hi All,

It has been an interesting conversation. Many thanks for everyone’s input.

However, I think we do have a reasonable potential solution.

It was Sebastian’s suggestion about governing at an intra-archetype level that has caught my attention - marking an existing data element as outdated, and adding a new one as a revision solves the issue of having correct vs incorrect units and avoids the necessity of a new version immediately. I suggest we make this modification to the existing v1 and republish as stable (and technically correct).

The other breaking changes suggested are effectively ‘cosmetic’ in some ways – ie a more refined way to record the body site for the measurement that is congruent with the pattern that has evolved since the archetype was first published. And I suggest that we add this as a draft v2 – ie the way of the future.

Both archetypes can then be present in CKM – the published v1 and the newly proposed draft v2. Yes, there will be two atcodes related to ‘Tilt’ in the v1 archetype – one for use, one outdated - but implementers who are using this data element will be able to make their own decisions on what to do internally; those implementations who don’t use the data element will be unaffected. This will minimise disruption to existing implementations, allow new vendors to use the correct v1 atocode in new implementations and we can then choose to review and publish the v2 at the time of our choosing.

Comments?

In principle, I think CKM has to be seen as the ‘source of truth’ wherever possible.

I really like this solution proposed by Sebastian as it offers us a way to govern that is finer grained than simply: draft vs published; v1 vs v2. We need to be mindful of this and use it as a more ‘delicate’ approach to our knowledge governance processes.

Regards

Heather

Hi Heather,

Although I agree with the idea of obsolete concepts, I wonder if it is necessary in this case of Tilt. Why can’t we just add the additional units as allowed options leaving the existing degrees symbol but in the element description indicate that this is obsolete and the correct units should be used instead.

The obsolete concept approach could be used for your body site improvement for example.

Regards

Heath

I’m curious of how this obsolete flag would be supported in a implementation agnostic view.
How it is different of having several implementation guides for different MU levels, an epSOS implementation guide (which changed the CDA reference model itself), or even better, FHIR resources with same id in different DSTU? The industry will use what the solution requires. In case of (clinical driven) archetypes, implementation issues should be the less important part : just create clinicaly correct models and the industry will use them as needed.
Personally I think the solution of just versioning is far more direct and less complicated than every other alternative.