Reason for raising the concern:
· In my view, there is a semantic nuance between the two sub-points highlighted in yellow above and the definitions of the "confirmed" and "unconfirmed" codes from the AllergyIntolerance Verification Status value set.
o Whilst the wording in the sub-points may not intend to define the usage, it introduces terms that are different, and thus possibly semantically different, to those used in the published definitions.
o There are changes to the definitions and concepts in the value set itself between R4 and CI build, which may indicate that the community is actively refining the value set.
§ In particular, the latest published definition for "confirmed" is: "The propensity for a reaction to the identified substance has been objectively verified (which may include clinical evidence by testing, rechallenge, or observation)". Highlighting that "observation" has been included in the definition. The usage in the proposal calling out that "confirmed" is "typically through clinical investigation" may be at odds with clinical practice as immunology testing is often not routine, or indicated to ascertain that there is a high level of certainty about the propensity for a reaction to the identified substance on re-exposure. Note that the interpretation of "clinical investigation" in the proposal may be providing guidance that clinical (immunology) testing, as opposed to "observation" is where use of "confirmed" is more appropriate. So, for example, a scenario where the patient is administered a medicine and observed to manifest a reaction may not qualify the usage of "confirmed", which I disagree with.
· In my view, the two sub-points do not offer further clarity to the existing definitions in the value set.
· There are still differences with guidance in US Core that appear to conflict - noted in the comments of FHIR-45039. Acknowledge that US Core may not be "correct" but in that case, should AU Core call out the difference?
· The statement "The majority of allergy or intolerance records in some systems will use this status." seems unnecessary. What is the rationale for making a statement about what "some systems" do? Furthermore, it suggests that there may be differences in the usage of "verification status" amongst systems, which may be supported by the responses in the AU Core Allergy Intolerance Vendor Support page.
My proposal as an alternative to point 3:
"The verificationStatus element is used to indicate certainty associated with the propensity, or potential risk, of a reaction to the identified substance (including pharmaceutical product) and SHALL be provided unless the clinicalStatus is “entered-in-error”. This is applicable for both allergies or intolerances and negated allergies or intolerances."
In summary, my proposal omits point 3 sub-points as I believe AU Core should defer to the definitions from the AllergyIntolerance Verification Status value set.
Alternatively, the TDG could consider seeking guidance from the AU Core CDG on the original proposal.
Updated text based on feedback from Step:
Reason for raising the concern: · In my view, there is a semantic nuance between the two sub-points highlighted in yellow above and the definitions of the "confirmed" and "unconfirmed" codes from the AllergyIntolerance Verification Status value set. o Whilst the wording in the sub-points may not intend to define the usage, it introduces terms that are different, and thus possibly semantically different, to those used in the published definitions. o There are changes to the definitions and concepts in the value set itself between R4 and CI build, which may indicate that the community is actively refining the value set. § In particular, the latest published definition for "confirmed" is: "The propensity for a reaction to the identified substance has been objectively verified (which may include clinical evidence by testing, rechallenge, or observation)". Highlighting that "observation" has been included in the definition. The usage in the proposal calling out that "confirmed" is "typically through clinical investigation" may be at odds with clinical practice as immunology testing is often not routine, or indicated to ascertain that there is a high level of certainty about the propensity for a reaction to the identified substance on re-exposure. Note that the interpretation of "clinical investigation" in the proposal may be providing guidance that clinical (immunology) testing, as opposed to "observation" is where use of "confirmed" is more appropriate. So, for example, a scenario where the patient is administered a medicine and observed to manifest a reaction may not qualify the usage of "confirmed", which I disagree with. · In my view, the two sub-points do not offer further clarity to the existing definitions in the value set. · There are still differences with guidance in US Core that appear to conflict - noted in the comments of FHIR-45039. Acknowledge that US Core may not be "correct" but in that case, should AU Core call out the difference? · The statement "The majority of allergy or intolerance records in some systems will use this status." seems unnecessary. What is the rationale for making a statement about what "some systems" do? Furthermore, it suggests that there may be differences in the usage of "verification status" amongst systems, which may be supported by the responses in the AU Core Allergy Intolerance Vendor Support page.
My proposal as an alternative to point 3:
"The verificationStatus element is used to indicate certainty associated with the propensity, or potential risk, of a reaction to the identified substance (including pharmaceutical product) and SHALL be provided unless the clinicalStatus is “entered-in-error”. This is applicable for both allergies or intolerances and negated allergies or intolerances."
In summary, my proposal omits point 3 sub-points as I believe AU Core should defer to the definitions from the AllergyIntolerance Verification Status value set. Alternatively, the TDG could consider seeking guidance from the AU Core CDG on the original proposal.