Hi All

I am in favour of a process that allows gentle change. The degree change (DEG) 
is minor and the choice of units would not have any implications for safety as 
they are alternatives and the numerical value would not change. I would suggest 
that this change is made to both archetypes (V1 and V2 draft).

I would suggest that the more considerable change be made to both archetypes as 
well but as an alternative, marking the location value as obsolete. You might 
ask all archetype users how many have any data that uses the location cluster? 
When and what are the implications?

I would then suggest that we have a major review of the version 2 draft and 
ensure it is fit for purpose in high intensity environments like ICU and 
anaesthesia. Are there any state variables that might be worth introducing for 
cardiac purposes? Is there standardisation of 24hr BP monitoring? And put out a 
version 2 archetype that has a long life.

The implications in systems of versioning archetypes are unknown at present but 
it is clearly a fundamental step. If we go through the process and no data is 
actually needing to be updated, then we have responded to a theoretical 
problem. If we go to version 2 of a very common archetype we are introducing 
complexity, increasing the likelihood of error and it will mean that all BP 
queries have to find and work with 2 different archetypes (when perhaps all 
data is the same!). According to the specs we will issue a transformation 
script (at least open source it) that updates all existing data to avoid 
different interpretations.

We need to use this as an opportunity for empirical learning around a step that 
we have planned for a long time ago.

Just my thoughts.

Cheers, Sam



From: openEHR-clinical [mailto:openehr-clinical-boun...@lists.openehr.org] On 
Behalf Of Gunnar Klein
Sent: Tuesday, 20 October 2015 10:26 AM
To: For openEHR clinical discussions <openehr-clinical@lists.openehr.org>
Subject: Re: Archetype publication question - implications for implementers


Dear ckm lovers,

My preference is for your option 3. We have to make updates. Nobody is forced 
to change anything.

Best regards

Gunnar
Den 2 okt 2015 06:11 skrev "Heather Leslie" 
<heather.les...@oceaninformatics.com<mailto:heather.les...@oceaninformatics.com>>:
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<http://ckm.openehr.org/ckm/#showArchetype_1013.1.130>, 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<http://ckm.openehr.org/ckm/#showArchetype_1013.1.2189>) 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<http://www.oceaninformatics.com/>
Clinical Programme Lead, openEHR Foundation<http://www.openehr.org/>
p: +61 418 966 670<tel:%2B61%20418%20966%20670>   skype: heatherleslie   
twitter: @omowizard


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