Dear Heather,

Thank you for sharing this challenge of defining good practice.

Firstly it was very helpful to have your description of the background to the 
changes made, and to be able to look at both archetypes side-by-side. This 
makes it easy to see the details not only which nodes have changed, but also to 
identify the impact that new nodes will have on what information might be 
placed in nodes that have not changed.

My reflections, some of which reiterate what you've said.

1) The NEHTA Pathology Test Result archetype is substantially different from 
the original Laboratory test archetype. It is not a minor tweak, and it is not 
"backwardly compatible".

2) The scope of both is sufficiently the same that it would not be justified to 
retain both as current usable archetypes.

3) Even though it is classified as draft, for the reasons you give and the fact 
that it has been accessible since 2009, the original Laboratory test archetype 
should be deprecated but not purged. The NEHTA Pathology Test Result archetype 
is the appropriate successor.

4) It is unfortunate that our archetype identifiers contain strings that imply 
the concept. We seem here to have two Concept Name strings that are physically 
different, but are colloquially often considered synonyms. One would surely 
wish to find the NEHTA path archetype whether searching for a pathology or a 
laboratory test result archetype? Ideally one would modify both archetypes to 
include both concepts, or attach a synonym to each to enable them to be 
cross-referenced (e.g. via the Keywords?). If that is felt not to be 
appropriate, it would make sense for them both to be classified as pathology 
test results. (These tests are no longer only done in laboratories!)

5) Any EHR system that has accumulated data according to the old archetype, and 
any applications that present data or capture data fashioned according to that 
archetype, will need significant change to use the new one. Changing archetype 
IDs would seem to be a very small portion of the overall workload involved and 
yet actually quite important for clinical governance. Whether the NEHTA path 
archetype identifier includes letters that read like the word "lab" or letters 
that read like to work "path", and contains a version integer that is one or 
two, is less important than knowing that it is a unique identifier which is not 
the same as the older archetype, and that there is a means of knowing in the 
repository that one is deprecated and the other has succeeded it. I appreciate 
that this is sometimes done by keeping the archetype identifier string the same 
and notching up the version integer. Surely this case illustrates why that 
might not always prove a robust method?

I must confess that I have read your options a few times but haven't formed a 
firm impression on which one is the right choice. I appreciate this may be 
unhelpful, and apologise for this, but I hope my reasoning above at least helps 
you, Ian and others to come to a good decision!

Well done for pushing the challenges and quality assurance of archetype 
development to such a high standard that these issues surface and cause us 
difficulty. It's a real tribute to your success.

With best wishes,

Dipak
________________________________________________________
Dipak Kalra
Clinical Professor of Health Informatics
Director, Centre for Health Informatics and Multiprofessional Education
University College London
Holborn Union Building, Highgate Hill, London N19 5LW
Honorary Consultant, The Whittington Hospital NHS Trust, London

Phone: +44-20-7288-5966

On 27 Jul 2012, at 01:29, "Heather Leslie" <heather.leslie at 
oceaninformatics.com<mailto:heather.leslie at oceaninformatics.com>> wrote:

Hi everyone,

Ian McNicoll and I, as openEHR CKM Knowledge Administrators, are seeking some 
feedback regarding a complex governance process in the openEHR CKM. It is a 
complex area and we will still be learning for some time to come. Your thoughts 
will help us to develop our current processes further?

We have had many archetypes in the draft state for some time in CKM. We think 
it likely that a number have been used within systems, despite the draft 
status. We don?t have any metrics on the extent of the use ? there is no 
reliable way to tell from downloads of the models, nor any voluntary usage 
system ? but that issue is for solving in the future and not the purpose of 
this email.

While we have a specific use case in mind at present, this scenario has the 
potential to re- occur with some of the current archetypes that have been in 
draft state for a length of time. So principles of governance are of high 
priority, not just reacting to management of one specific model in isolation.

Within the Australian context, Grahame Grieve has collaborated to update the 
current OBSERVATION.lab-test archetype 
-http://www.openehr.org/knowledge/OKM.html#showarchetype_1013.1.350 - (first 
authored in 2009), consistent with his knowledge of lab systems and HL7 
practice. While there are many data elements consistent with the openEHR 
archetype, the new NEHTA archetype - 
http://dcm.nehta.org.au/ckm/OKM.html#showarchetype_1013.1.1019_5 (and currently 
on a branch) - has had to  change in a number of ways to cater for additional 
use cases and including more alignment with v2 messaging etc ? all very useful, 
I?m sure you?ll agree. The NEHTA archetype therefore really reflects our 
current understanding of ?best practice?, although the archetype will  no doubt 
undergo some further refinement in a collaborative review process.

So, the major changes affecting implementers:

?         The ID and concept name of the new archetype has been changed to 
OBSERVATION.pathology_test and ?Pathology Test Result?. Grahame advises that 
from a pure semantic view, pathology tests are really a subset of lab tests and 
justifies using a more specific term.

?         Unfortunately, the data changes are not backwardly compatible, 
especially the ?Result? node  ? largely because of the creation of new paths, 
rather than deletion of data elements. In the data elements that persist, the 
atcodes have been carried through into the new archetype to minimise potential 
confusion, although sometimes the names have been finessed a little :).

?         There are some new data elements, but these will not impact 
implementers in the same way as the first two dot points.

Our usual governance policy, which I think works sensibly in principle, is that 
while an archetype is in a draft state, any implementation is at risk as until 
collaboration has taken place and consensus reached by the review team, it is 
possible and indeed very likely that the archetype will undergo significant 
change from its initial upload, and this usually involved breaking changes as 
we update structure and change paths etc during the refinement process. While 
Editors seek to ensure only reasonable models are uploaded in the first place, 
there is no guarantee that they will not change significantly as domain experts 
impart their wisdom!
Further, once an archetype is published as v1, then the current policy requires 
that backwardly compatible changes can be managed by creating a new revision of 
the archetype but non-backwardly compatible changes require a new version of 
the archetype as v2, v3 etc.

So in this special situation, where we suspect that there has been a number of 
implementations of the original draft archetype, we are interested in receiving 
your feedback as to process you prefer. In all situations, implementers will 
need to manage the new archetype data element structure in their systems. All 
options have pros and cons:

?         Option 1:  Reject the original draft ?Laboratory test? archetype and 
upload the new ?Pathology Test Result? archetype, making sure there is adequate 
supportive information for implementers to understand why the archetype has 
been rejected and what has replaced it. All provenance of the original 
?Laboratory test? archetype will be preserved. The new ?Pathology Test Result? 
v1 archetype will contain a reference to the openEHR ?Laboratory Test? v1 
archetype and the NEHTA archetype in its metadata to support provenance (ie 
provenance will be preserved and the location will be made explicit).

o   Implementers: will have to modify their systems with the new archetype ID 
and structure

o   Knowledge Governance: Semantically clean way to ensure that the CKM pool of 
archetypes is representing academic best practice.

?         Option 2: Update the current archetype ID (lab_test.v1 to 
pathology_test.v1) and Concept name from ?Laboratory test? to ?Pathology Test 
Result?, then upload the new ?Pathology Test Result? archetype content ? 
keeping the same CKM internal ID including directly preserving all provenance 
and associated details accumulated to date.

o   Implementers: will have to modify their systems with the new archetype ID 
and structure

o   Knowledge Governance: Another semantically clean way to ensure that the CKM 
pool of archetypes is representing academic best practice.

?         Option 3: Keep the current archetype ID (lab_test.v1), update the 
Concept name only to ?Pathology Test Result?, then upload the content of the 
Pathology Test Result? archetype as a new iteration of the lab_test.v1

o   Implementers: will have to modify their systems with the new archetype 
structure only.

o   Knowledge Governance: The structure of the archetype represents academic 
best practice. There is a mismatch between the archetype ID (which effectively 
has no semantics) and the Concept Name ? this may cause some confusion, 
especially with clinicians. We might have to explain this mismatch for a very 
long time and it may be perpetuated throughout other related CKM national 
instances!
This option will result in a non-alignment between the NEHTA CKM and the 
openEHR CKM. While it is probably inevitable that this kind of diversion of 
models will happen over time, the question is whether this is acceptable or 
desirable in this relatively early phase of model development and governance.

?         Option 4: Same as Option 3 but upload the ?Pathology Test Result? 
archetype as a new version, ie lab_testv2, even though the lab_test.v1 has 
never been published.

o   Implementers: will have to modify their systems with the new archetype ID 
and structure. The new version will be a visual indication of significant 
change in the structure of the archetype.

o   Knowledge Governance: As with Option 3, the structure of the archetype 
represents academic best practice, but the ID (which effectively has no 
semantics) and the Concept Name are still mismatching ? this may cause some 
confusion, especially with clinicians. Creating a new version in this situation 
breaks our fledgling governance policy principles, but may be viewed as a 
pragmatic solution.
As in Option 3, there will again be a non-alignment between the NEHTA CKM and 
the openEHR CKM  resulting from this approach. While it is probably inevitable 
that this kind of diversion of models will happen over time, the question is 
whether this is acceptable or desirable in this relatively early phase of model 
development and governance.

Needless to say this has caused some lively discussion amongst those I have 
asked so far. There has been no real consensus arising from those limited 
discussions, hence my request for feedback from the broader community.

Teasing it out we are dealing with a number of issues tied in together:

?         We need to manage inclusion of breaking changes to a draft archetype 
that has probably been implemented in a number of systems, despite the draft 
state. We are pretty sure that this situation is not unique and we will need to 
apply government principles here ? either keep it as v1 draft (as justified by 
a ?draft model users beware? notion) or update it to v2. This is covered by 
Options 3 & 4

?         We want to potentially change the Concept Name of the archetype, and 
it possibly makes sense to change the Archetype ID to keep them aligned ? this 
additional change provides us with Options 1 and 2 above, in addition to 
Options 3 & 4.

There are tensions. We have to make pragmatic decisions where there is real 
impact on implementers, we want to develop and apply governance principles 
systematically, and at the same time we have a responsibility to set these 
models up to be as rigorous and semantically sensible as we can, while we can. 
We know that over time, we will have to make compromises ? the art (or science) 
is working out how much compromise and when!

Many thanks

Heather and Ian


Dr Heather Leslie
MBBS FRACGP FACHI
Director of Clinical Modelling
Ocean Informatics<http://www.oceaninformatics.com/>
Phone (Aust) +61 (0)418 966 670
Skype - heatherleslie
Twitter - @omowizard

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