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 skype: heatherleslie twitter: @omowizard
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