Stream: implementers
Topic: AllergyIntolerance - clinical status of refuted allergies
Jose Costa Teixeira (Mar 12 2020 at 19:14):
What is the clinical status for an allergy that was refuted?
Example:
- Patient tells GP they are allergit to penicillin (clinicalStatus=active?, verificationStatus=presumed)
- Patient undergoes tests and it is not an allergy, just a minor known side effect (clinicalStatus=????, verificationStatus=refuted)
The clinicalStatus is not clear to me from the value set
http://build.fhir.org/valueset-allergyintolerance-clinical.html
Lloyd McKenzie (Mar 12 2020 at 19:50):
Based on the definitions, it would be 'Resolved' (which is a specialization of 'inactive') I.e. it should no longer trigger alerts
Jose Costa Teixeira (Mar 12 2020 at 19:56):
ok thanks
Jose Costa Teixeira (Mar 12 2020 at 20:00):
and the first one?
verification status=presumed => clinicalStatus=active?
Lloyd McKenzie (Mar 12 2020 at 21:08):
Active. Presumed means you'd certainly want it to be checked
Gay Dolin (May 26 2020 at 20:02):
@Lloyd McKenzie Doesn't that really state the the allergy refutation is resolved? Seems that perhaps there is a new rule needed here (http://hl7.org/fhir/R4/allergyintolerance.html#invs ) "if Verification status is "Refuted" Don't populate Clinical Status"
Gay Dolin (May 26 2020 at 20:07):
From a clinical perspective. Maybe the patient just had some skin testing lab observation result, and you never had an allergy observation in the first place
Russell Leftwich (May 27 2020 at 21:17):
Active. Presumed is the usual case. Laboratory or skin tests exist for less that 2% of possible drug allergies. And direct challenge, the other possible verification, is done only rarely because of the expense and risk. It is in the overwhelming majority that an allergy/intolerance is based on history or observation. The other scenario that I would consider "verification" is, it happened 3 times (or more) with the same drug (substance) and the same reaction.
Gay Dolin (May 29 2020 at 16:58):
@Russ - the real question is, if the an allergy is refuted, what is the clinical status? Are you saying "active" is the clinical status for a refuted allergy? There is no "presumed" status in either clinical or verification status
Simone Heckmann (Jul 14 2020 at 11:38):
We are currently having the exact same discussion about Condition: What's the appropriate clinicalStatus, if the verificationStatus is "refuted"?
Lloyd McKenzie (Jul 14 2020 at 14:15):
@Michelle (Moseman) Miller
Michelle (Moseman) Miller (Jul 14 2020 at 15:53):
Are you asking about R4 or latest build? We've made a number of changes....
- In R4, the con-3 invariant was "downgraded" from Rule to Guideline, which should mean that you can leave clinicalStatus empty, if needed, as long as validator isn't enforcing best practices
- In build, we approved changes that are not yet applied J#22973, which includes changing the SHALL to a SHOULD
Jose Costa Teixeira (Jul 14 2020 at 17:47):
I don't get the relation...
In this thread I see three possibilities: When VerificationStatus is refuted, the clinicalStatus is
- empty
- active
- resolved
which one would be best?
Dave Carlson (MIE) (Jul 14 2020 at 19:40):
I have a similar question that I'm going to put here, even though my original question was with conditions, but, allergies also has a similar refuted status.
How would most suggest storing a patients "refutation" of having an allergy (or condition, or similar medical concepts), ie, in a discussion with a doctor/nurse, or maybe more commonly in filling out a checklist form.
It seems like it might make sense to have verificationStatus "refuted" and the asserter be the patient themselves (or possibly a RelatedPerson for a caregiver).
But, the wording on FHIR for these definitions seems to be too narrow to use it some of these scenarios currently:
- The issue above with a refuted allergy or condition having any sort of clinical status... to me the "The subject is no longer experiencing the symptoms" suggests they have in the past, which isn't necessarily accurate if the condition is refuted, which could mean they've never had it
- This issue... the wording of refuted with "has been ruled out by diagnostic and clinical evidence.", doesn't really jive with a patient just telling you "I don't have this"... there is no diagnostic or clinical evidence there.
I am guessing the answer might be that "patient provided information" such as this is something that gets stored in a completely different way (questionnaire?), but, we at least generally do store them in the same "table/bucket" per se within our system, so, it still seemed relevant possibly to send it this way via FHIR.
Simone Heckmann (Jul 16 2020 at 08:24):
Jose Costa Teixeira said:
I don't get the relation...
In this thread I see three possibilities: When VerificationStatus is refuted, the clinicalStatus is
- empty
- active
- resolved
which one would be best?
^ this
Michelle (Moseman) Miller (Jul 23 2020 at 01:48):
Initially:
Patient tells GP they are allergic to penicillin
At this point in time (allergy hasn't been refuted yet), I agree with the earlier guidance that clinicalStatus should be active based on the definition of active being:
The subject is currently experiencing the condition or situation, there is evidence of the condition or situation, or considered to be a significant risk.
However, after some period of time, the allergy is subsequently refuted per
Patient undergoes tests and it is not an allergy, just a minor known side effect
My earlier response applies to this point in time (when the allergy has been refuted)
In R4... you can leave clinicalStatus empty, if needed, as long as validator isn't enforcing best practices
Once the allergy has been refuted, clinicalStatus = active would no longer be appropriate since (based on definition of active above) the patient isn't experiencing the condition, nor is there any evidence of the condition, nor is it considered to be a risk after it has been refuted.
Dave Carlson (MIE) (Jul 23 2020 at 18:43):
Nobody has thoughts/suggestions on my previous post in this thread of storing a patients "refutation" of having an allergy/condition/etc, or thoughts on the specificity of how FHIR is currently wording the "refuted" verificationStatus type?
Jose Costa Teixeira (Jul 23 2020 at 19:37):
I don't see the answer to my question - I think we're down to 2 options.
What is the clinical status of a refuted allergy?
- empty
active- resolved
Jean Duteau (Jul 23 2020 at 19:39):
inactive or resolved - depending on testing
Jean Duteau (Jul 23 2020 at 19:40):
refuted: A propensity for a reaction to the identified substance has been disputed or disproven with a sufficient level of clinical certainty to justify invalidating the assertion. This might or might not include testing or rechallenge.
inactive: The subject is no longer at risk of a reaction to the identified substance.
resolved: A reaction to the identified substance has been clinically reassessed by testing or re-exposure and is considered no longer to be present. Re-exposure could be accidental, unplanned, or outside of any clinical setting.
Dave Carlson (MIE) (Jul 23 2020 at 20:52):
Jean, maybe I am parsing words here too much, but "The subject is NO LONGER at risk of a reaction to the identified substance.", the "no longer" to me suggests they were at one point.... if you are marking refuted, that would suggest it was as stated initially marked " unconfirmed" (Jose said "Presumed", I don't see that as a named option, I assume we mean, "unconfirmed"), but, then decided that they didn't have the allergy/intolerance, most likely ever, which moves it to "refuted".
Resolved is really no better with the wording of " is considered no longer to be present. " That suggests at one point it was present.
None of the 3 clinicalStatus descriptions to me seem to be saying "The subject has NEVER had a reaction to this substance", which to me suggests leaving ClinicalStatus blank for "refuted". I am agreeing with Gay Dolin's that someone starting an A/I as "Unconfirmed", and then moving it to "Refuted", the refuted (at this point, without modification to the descriptions) verificationStatus should have an empty clinicalStatus.
Jose Costa Teixeira (Jul 23 2020 at 21:19):
I think the descriptions should be revisited
John Moehrke (Jul 23 2020 at 21:58):
note that the #patient empowerment workgroup is running a project specifically on the use-case of a patient requesting corrections.
Jean Duteau (Jul 23 2020 at 22:02):
If you have an unconfirmed/active allergy - you are stating that you believe the patient is at risk for a reaction but you don't have confirmation. Then you do something that causes you to no longer believe the patient is at risk - you refute the allergy and you make it either inactive or resolved based on whether you tested/re-exposed/whatever.
Jose Costa Teixeira (Jul 23 2020 at 22:12):
In my case at top of thread, the patient was never allergic. The valueset does not allow this to be represented by active nor resolved
Jose Costa Teixeira (Jul 23 2020 at 22:12):
Because the text reads "no longer"
Jose Costa Teixeira (Jul 23 2020 at 22:13):
At least that is how.i read it. Why else would the words 'no longer' be there?
Jean Duteau (Jul 23 2020 at 22:13):
i read your case at the top and it didn't say the patient was never allergic. it said that the patient told the GP that they were allergic. That would get recorded as a Unconfirmed/Active allergy. Then when the GP looked into it and thought the patient was full of baloney, he changes the statuses to "refuted/inactive" or perhaps he does some simple testing and then changes it to "refuted/resolved"
Jean Duteau (Jul 23 2020 at 22:14):
that is exactly how it works in SK
Jose Costa Teixeira (Jul 23 2020 at 22:16):
Refuted in this case means 'patient is actually not allergic, this was not an allergic reaction, this was an expected ADE'.
Jose Costa Teixeira (Jul 23 2020 at 22:17):
If inactive means 'it was never there or if it was, it is no longer' I'd say that refuted/inactive applies
Jose Costa Teixeira (Jul 23 2020 at 22:18):
But inactive says 'no longer at risk'. Those are specific words, I cannot assume they mean something more generic, right?
Jean Duteau (Jul 23 2020 at 22:18):
assuming the GP believed the allergy to be real when he first entered it, then the realization that the patient wasn't actually allergic means "I used to think that the patient was at risk of a reaction but I no longer think that"
Jose Costa Teixeira (Jul 23 2020 at 22:21):
Go said it was presumed and referred to allergy specialist (allergist? Allergologist? Allergologologist?)
Jose Costa Teixeira (Jul 23 2020 at 22:22):
Perhaps in first step I should use unconfirmed instead of presumed
Jean Duteau (Jul 23 2020 at 22:23):
yes, mainly because there is no "presumed" code :)
Jose Costa Teixeira (Jul 23 2020 at 22:25):
For verification status, I mean
Jean Duteau (Jul 23 2020 at 22:26):
there is no 'presumed' in either status value set
Jose Costa Teixeira (Jul 23 2020 at 22:28):
http://build.fhir.org/valueset-allergyintolerance-verification.html
Jean Duteau (Jul 23 2020 at 22:29):
ah, i'm stuck in R4. my apologies
Jean Duteau (Jul 23 2020 at 22:29):
since Presumed is a child of unconfirmed, nothing I've said above changes.
Peter Jordan (Jul 24 2020 at 02:12):
When referring to 'reactions' here I think that we need to be clear that we are referring to adverse reactions, not just reactions per se.
Michelle (Moseman) Miller (Jul 24 2020 at 02:14):
@Jose Costa Teixeira Can you elaborate on why there are still remaining questions as I tried to directly answer "empty" a couple times above, so I must be missing why you think the question is still unanswered (my apologies).
@Dave Carlson (MIE) To the question of how to represent a checklist Q&A about the absence of a condition or allergy, I think the guidance we have in Condition (http://build.fhir.org/condition.html#9.2.4.5) sums it up:
It is common as part of checklists prior to admission, surgery, enrollment in trials, etc. to ask questions such as "are you pregnant", "do you have a history of hypertension", etc. This information should NOT be captured using the Condition resource but should instead be captured using QuestionnaireResponse or Observation. In this case, the combination of the question and answer would convey that a particular condition was not present.
Michelle (Moseman) Miller (Jul 24 2020 at 02:20):
@Dave Carlson (MIE) I agree with your assertion
maybe I am parsing words here too much, but "The subject is NO LONGER at risk of a reaction to the identified substance.", the "no longer" to me suggests they were at one point....
Condition has guidance, which could also apply to AllergyInterolerance (feel free to log change request to add a similar note to AllergyIntolerance)
It is appropriate to capture a "refuted" Condition record if the Condition was considered present and subsequent evidence refuted it. Specifically, Condition.verificationStatus can convey refuted.
Michelle (Moseman) Miller (Jul 24 2020 at 02:29):
@Jose Costa Teixeira
I think the descriptions should be revisited
Feel free to log a change request with proposed edits. (Side note: Patient Care recently approved updates to Condition.clinicalStatus code definitions per J#26464)
That said, per my prior comment to Dave, we don't expect to have records for allergies or conditions that were never considered to be present (e.g. the checklist use case mentioned above), but if there are other edits we can make to clarify definitions for conditions/allergies that were once believed to be present, please do log the change request so we can continue to refine the definitions.
Jose Costa Teixeira (Jul 24 2020 at 07:24):
Michelle (Moseman) Miller said:
Jose Costa Teixeira Can you elaborate on why there are still remaining questions as I tried to directly answer "empty" a couple times above, so I must be missing why you think the question is still unanswered (my apologies).
I saw the indication that it could be empty if needed, I did not see that as an indication of "in that case is should/shall be empty". I'll use that, thanks.
Perhaps we could add such guidance?
Jose Costa Teixeira (Jul 24 2020 at 07:25):
(I think this deserves assertive guidance)
Dave Carlson (MIE) (Jul 24 2020 at 13:20):
Michelle (Moseman) Miller said:
Jose Costa Teixeira Can you elaborate on why there are still remaining questions as I tried to directly answer "empty" a couple times above, so I must be missing why you think the question is still unanswered (my apologies).
Dave Carlson (MIE) To the question of how to represent a checklist Q&A about the absence of a condition or allergy, I think the guidance we have in Condition (http://build.fhir.org/condition.html#9.2.4.5) sums it up:It is common as part of checklists prior to admission, surgery, enrollment in trials, etc. to ask questions such as "are you pregnant", "do you have a history of hypertension", etc. This information should NOT be captured using the Condition resource but should instead be captured using QuestionnaireResponse or Observation. In this case, the combination of the question and answer would convey that a particular condition was not present.
Thanks Michelle, as I stated, that is what I thought with the checklist Q&A, (using questionnaire or something else), thanks for pointing out that wording.
It sounds like we have some consensus for some sort of modification to either some of the language surrounding the inactive setting (adding ", or never had," after "at risk of" in the description?) or adding the guidance officially that for refuted VerificationStatus, that the clinicalStatus should be blank. I think whatever is decided here should also get applied to conditions, and possibly other elements as well, but, I'd have to review those more closely.
Dave Carlson (MIE) (Jul 24 2020 at 13:28):
I just read the rewording on that request change: https://jira.hl7.org/browse/FHIR-26464
The change to "not presently" instead of "no longer" IMO allows for the nuance of "never had" into the definition (although the "returning" at the end still makes that suggestion, it is less heavy handed than the "no longer" being at the beginning").
It does appear though that they didn't approve the wording change though, am I reading that correctly?
Michelle (Moseman) Miller (Jul 26 2020 at 02:31):
@Jose Costa Teixeira Feel free to create a JIRA asking for explicit guidance to be added in the spec.
@Dave Carlson (MIE) J#26464 was approved -- the revised wording is documented in the resolution description field. Specifically, the bolded text (prefixed by "Change")
Michelle (Moseman) Miller (Sep 09 2020 at 17:35):
Logged J#28458 to add explicit guidance for clinicalStatus to be empty when verificationStatus is refuted
Last updated: Apr 12 2022 at 19:14 UTC
