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 J.

.         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
 <http://www.oceaninformatics.com/> Ocean Informatics
Phone (Aust) +61 (0)418 966 670
Skype - heatherleslie
Twitter - @omowizard

 

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