Adverse event risk, resolution/end date/abatement

Adverse event risk is the equivalent to allergy intollerance in FHIR. For the EHDS model a field end-date (Date of resolution of the allergy (e.g. when the clinician deemed there is no longer any need to track the underlying condition)) is added. Which will be added as an extension in the EU base profiles.Here it is named abatement: The date or estimated date that the allergy or intolerance resolved. This is called abatement because of the many overloaded connotations associated with resolution.

I cannot find an equivalent field in Adverse event risk are there any ways of expressing this end date in the reference model? or is this something that is missing in the openEHR model worth adding.

Any feedback?

Hey Wouter, the 2 links seems to be the same page and I can’t find the ā€œabatementā€ term. Am I searching wrong?

@IEB , @CPB please have a look to this post :slight_smile:

It is interesting that this is not in the original FHIR resource, but is an IPS/EPS extension and UK FHIR Core also extends the resource to capture Abatement date and Reason for abatement.

Perhaps one to discuss with FHIR community and make a decision in common?

This is the EU Core AllergyIntolerance profile: AllergyIntolerance (EU core) - HL7 Europe Base and Core FHIR IG v2.0.0

The IPS AllergyIntolerance profile also has an extension for ā€˜abatement’: AllergyIntolerance (IPS) - International Patient Summary Implementation Guide v2.0.0

In the EHDS Logical Model that Wouter sent a link to it is called ā€˜endDate’

Personally, I think ā€˜abatement’ is clinically dodgy for Condition and a technical simplification, much like saying pregnancy status is binary. The comment that ā€œthis is called abatement because of the many overloaded connotationsā€ is a little ironic. In my opinion, it creates as many problems as it attempts to solve.

In the Problem/Diagnosis qualifier we have both a ā€˜Resolution phase’ and a ā€˜Remission status’, precisely because these are different clinical concepts. To then have a single date of ā€˜abatement’ that conflates them is problematic from the outset. Conditions that go into remission can be reactivated, whereas something that is resolved generally does not recur. The date of remission is semantically unique and clinically important and should be treated separately. The condition will often require long-term surveillance to ensure that the patient remains in remission.

When it comes to adverse reactions, the situation is even more problematic. Can clinicians ever say with certainty that there is no longer a risk of a reaction? Only a brave one, unless there is evidence that the original allergy record never represented a true allergy in the first place. The risk or propensity of a reaction on re-exposure may decrease significantly after hypersensitivity treatment, and some children may appear to outgrow a reaction. However, could the average clinician safely conclude that there is zero future risk and remove it from the active health record or from active drug interaction checking? Is the risk dose-dependent? Will the effect of hypersensitivity treatment diminish over time? Who knows? More importantly, who is willing to take responsibility for that decision? Not me. Recording an allergy as ā€˜resolved’ or cured seems fraught with medicolegal risk.

However, Australia is often described as the allergy capital of the world. Epidemic proportions, apparently. But how real is it? That is the question that has been posed to our National Allergy Council (NAC). A significant part of the issue concerns the apparently low threshold at which a suspected allergy is documented in our clinical systems. In response, NAC are developing a strategy for ā€œdelabellingā€ documented allergies that are found to have no supporting evidence. As I understand it, this work is focused primarily on penicillin allergy and they are aiming for it to be scalable so that it can be replicated in the community and not dependent on allergy specialists alone.

Importantly, this is not the same as assigning the technical status ā€˜entered in error’. The clinician may have had legitimate concerns that the clinical story was consistent with an allergy, but this precautionary approach has resulted in many allergy labels being recorded without adequate evidence. It is the process of disproving precautionary or poorly substantiated allergy labels that were originally recorded because the clinician preferred to record a possible allergy rather than risk missing a genuine one.

The dilemma for allergy specialists is that every claim of a penicillin allergy may need to be formally tested. Positive results should be accompanied by clear documentation of the supporting evidence. Negative results should also include the evidence from testing so that the same allergy label cannot simply be re-added later by another clinician acting ā€˜just in case’ an undocumented penicillin allergy might otherwise have been missed, perpetuating the never-ending cycle.

We are working with the NAC to understand the implications for AUCDI and, by extension for me, the openEHR archetype that underpins it. We are about to release AUCDI R3, in which we proposed including ā€˜Verification status’. However, in response to clinical feedback, ā€˜Verification status’ has been removed from the specification pending further discussion with NAC clinicians. I anticipate that this discussion may result in proposed changes to the archetype in the future. Verification methods and supporting evidence will need to be represented explicitly, potentially using the existing CLUSTER.clinical_evidence as part of a proposed solution.

Thanx for your extensive answer. I think you are right about abetement for Allergie. I am just wondering about Intollerances, I think those can ā€œendā€? As our archetype is about adverse risk, I could see risk become less significant or perhaps insignificant and therefor we would like them to end. This also seems to be the intention of the xtEHR model. So I think that we could add that to the archetype? Or would it be more likely that we get a qualifier CLUSTER archteype like for Problem/Diagnosis?

I think from Nictiz we might be able to contribute to the discussion as we had a Contra indication/Allergy group, that had some allergy specialists in it.

Yes also a good idea.

The reason why the archetype is ā€˜adverse reaction risk’ rather than specific allergy or intolerance or side effect or ?? is because many (?most) non-specialist clinicians cannot determine the pathophysiology underlying the reaction.

When I was in clinical practice, there are some reactions that are clearly allergic, many others that were not. I was not able or willing to label them or to determine that they were no longer relevant. And that was after 6 years of medical school and 14 years of practice. Maybe I just needed more practice?

But then we think about the clinical workforce with less training, and I’m thinking indigenous health workers in remote desert communities etc and the problem is concerning.

Why not just label them inactive?

Regards

Heather

That is a good question. I have no idea…

Guess we will need to discuss this in the mean time I still need to align with EHDS (as it will become law) and I guess other EU countries need to do so as well. So we might need to coordinate on how we implement the end date as an intermediate sollution.

While I agree about the risks of ā€˜abated drug reactions’, there is probably a case to be made for asserting abatement for non-drug allergies e.g tree pollen etc in general allergy practice, so that might be where the push is coming from.

It is interesting that the R6 allergyIntolerance resource still does not have Abatement Reason/ Date, and that this is purely an IPS extension - perhaps the same conversation happening there?. We should try to find out.

The short-term fix is just to add a CLUSTER to capture abatement, which does not need ot be ā€˜official Core’ openEHR. One way or another we need to be able to align, even if it remains contentious.

Tbh this, combined with some of the less-than-optimal modelling we’ve seen, is part of what scares me about EHDS :persevering_face:

This is just one of the differences between the EHDS Logical Models + EPS/IPS FHIR profiles and openEHR archetypes which we have been documenting as part of our work for Nictiz and the openEHR & FHIR IPS working group. As a next step, it would be good to have a wider community discussion about what to do with these findings and how to handle the mismatches. We briefly discussed this at the last @IEB meeting and agreed that these should be considered on a case-by-case basis rather than change the archetypes to align with all the EHDS requirements (some of which may not be optimal from the clinical informatics point of view, as Heather and Silje have pointed out). Perhaps it would be useful to have some EHDS/IPS workshop sessions where the main issues could be discussed and openEHR-recommended approaches agreed?

I think this is the perfect example for the use of a local (EU) CLUSTER archetype as Ian suggested. We could even use it in the ā€˜Extension’ SLOT in Protocol where it has the outdated, but still relevant, description of ā€œAdditional information required to capture local content or to align with other reference models/formalisms.ā€

Interestingly, while this is a longstanding pattern in our models, this is the first time I’ve recommended it. I wonder if Protocol would be OK in this situation? Ordinarily we’d place this data element in ā€˜Data’.

In the meantime, we can make enquiries of the clinical experts to determine if this is a good clinical requirement and valid for inclusion in the archetype