1. C-CDA: Problem/Allergy Problem Status Observation Templates and Clinical Status Updates from Chicago WGM
Stephen Chu, PCWG co-chair
Russ Leftwich, PCWG co-chair
Elaine Ayres, PCWG co-chair
Laura Heermann Langford, PCWG co-chair
Rob Hausam, vocab facilitator
Lisa Nelson, PCWG Liaison from SDWG

2. Background
C-CDA r2.0 deprecated two clinical status related templates:
Allergy status observation
Problem status
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3. In C-CDA 2.0 Allergy Status Observation and Problem Status templates are deprecated
Note – this was Slide 6 in the previous version 3
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4. In C-CDA 2.0 Allergy Status Observation and Problem Status templates are deprecated
Add “Note” to address this comment from Lisa: (this was Slide 7 in the previous version)
Slide 6&7 – This issue actually exists in more places that just these two examples.  The need to clarify the difference between a clinical status and the state model for the clinical statement is a much larger issue. If we clarify this principle, it will fix more than just these two examples.
Note – the issue of using statusCode + effectiveTime to represent condition status
appears to go beyond just Allergy and Problem in C-CDA R2.0
If the need to separate and disambiguate ACT state and condition status is accepted,
this decision can be applied to resolve other similar issues
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5. Decision to deprecate??? Confusions often resulted from
combined use of
these two sets of
codes (ActStatus +
ProblemStatus)
in CDA
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6. These templates are replaced by the problemConcernAct and problemObservation classes and four sets of elements:
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7. What have been lost by deprecating Allergy Status Observation template?
Table 126: Allergy
Status Observation
The “Note” is added to address this comment by Lisa:
Slide 4 – the point here should be that the original problem had two issues, not one.  Yes, the correct use of the act status was needed to fix the clinical statement model, but ALSO  the incorrect vocabulary binding for the value element of the clinical status observation needs to be fixed.
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8. What have been lost by deprecating Problem Status Observation template?
The Problem Observation in C-CDA 1.1
Health Status Observation: This template represents observations regarding the outcome of care from the interventions used to treat the patient. These observations represent status, at points in time, related to established care plan goals and/or interventions (Contains “Outcome Observation” template)
Outcome Observation contains: Act Reference (NEW); Author Participation (NEW); Goal Observation (NEW); Intervention Act (NEW); Progress Toward Goal Observation (NEW)
Uses same HITSPProblemStatus
values:
* Active
* Inactive
* Resolved
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9. What are the implications
What are the implications? (of deprecating the status observation templates)
Question:
Are the four
sets of
elements
adequate for
representing
complex and
rich semantics
of clinical and
verification
Status?
Lisa comment: (this was Slide 8 in the previous version)
Slide 8 – A VERY IMPORTANT SLIDE.  Issue of what is and isn’t human readable IS VERY IMPORTANT!!!
The Act status of that outer problemConcernAct controls the state model of the
Concern clinical statement
These rules set out how the Act status for the clinical statement will work
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10. What are the implications
What are the implications? (of deprecating the status observation templates)
problemConcernAct
<statusCode> (value = “active”; “complete”
<effectiveTime> (start + end concern is followed)
problemObservation
<statusCode> (value set to “completed”)
<effectiveTime> (when problem start +
end for the patient)
This slide is modified to address comment from Lisa:
Slide 12 – I’m concerned that this muddles the concepts.  This is what I am trying to “purify”.  The Clinical Statement Status is a mechanical data representation thing.  It is not human readable. It is a data processing thing associated with the clinical statement model itself.  This is what I call the “clinical statement model State Machine”.   This is totally different from the clinical status that is observed and associated with describing the clinical observation. This is clinical information that IS human readable.  In fact – this status information is represented in the value element, not in an act status structure in the model.
The state model of clinical statements that represent Problem Concern
observation needs to use these RIM state concepts in the statusCode
Problem Concern clinical statement in order to control the state model
for the clinical statement information to be properly processed by a machine
But …
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11. What are the implications
What are the implications? (of deprecating the status observation templates)
problemConcernAct
<statusCode> (value = “active”; “complete”
<effectiveTime> (start + end concern is followed)
problemObservation
<statusCode> (value set to “completed”)
<effectiveTime> (when problem start +
end for the patient)
But …
* The statusCode is:
- a mechanical representation of “clinical statement “state machine”
- “isDocumentProperty” of statusCode = true (≠ clinical property)
- not human readable (RIM: the statusCode does not carry meaning
that would be present in the human readable narrative)
- inadequate for complex and semantically rich clinical status
* The value element of the Problem Status observation is denoted with a
code element set of LOINC code (= status of diagnosis)
This slide is modified to address comment from Lisa:
Slide 12 – I’m concerned that this muddles the concepts.  This is what I am trying to “purify”.  The Clinical Statement Status is a mechanical data representation thing.  It is not human readable. It is a data processing thing associated with the clinical statement model itself.  This is what I call the “clinical statement model State Machine”.   This is totally different from the clinical status that is observed and associated with describing the clinical observation. This is clinical information that IS human readable.  In fact – this status information is represented in the value element, not in an act status structure in the model.
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12. Semantics of clinical status: much more complex
Clinical statements on allergy and intolerance status need to be represented by one of the following values:
Active
Inactive (semantically different from resolved)
Resolved
Other clinical conditions status observations need additional status values …
This slide is modified to address this comment from Lisa:
Slide 13:  This should say:  The state model for most clinical statements that represent problem concerns needs to use one of the following three state values (as a minimum) from the RIM act status model.
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13. Semantics of clinical status: much more complex
Other clinical conditions (e.g. CVS, respiratory, cancer, behavioural problems etc), require additional status values:
Remission states
In remission
Partial remission
Full/complete remission
Early full/partial remission
Sustained full/partial remission
Relapse states
Relapse
Suspected relapse
relapse after partial remission
relapse after full remission
Slide 14:  This slide shows that clinical status is a TOTALLY DIFFERENT THING. – Good slide. The MAGIC comes when you show that the concepts of Active, Inactive, and Resolved play a totally different role when used as clinical status concepts.    These three concepts need to be sprinkled in with these other clinical concepts
Note:
“relapse”, “suspected relapse”
may also apply to certain
infections, e.g. Ebola
haemorrhagic fever
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14. Clinical verification status
Joint PCWG – FHIR clinical resource development works (e.g.: on condition, allergy / intolerance, clinical assessment/impression) identifies need to include clinical verification status for tracking clinical workflow related status:
Differential
Provisional, working
Confirmed
Refuted
Unknown
Entered in error
Slide 17 and 18 :  Very Important point:  You need to be demonstrating the use of CLINICAL CONCEPTS like you have shown on slide 14.  If you only use the terms that caused this confusion in the first place (active, inactive, and resolved ---in the clinical sense) then you miss the opportunity to show the need to use the terms like “In Remission” or “Relapse”. The examples need to use the terms from slide 14, mixed in with uses of the “problem children” of active, inactive, and resolved” used as CLINICAL OBSERVATIONS (not clinical statement model statuses). [The point is that these same three words have different meaning within the two different contexts
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15. A simple clinical use case
First encounter:
A 16 yo male high student presented at ED with: fever, sore throat
cough, persistent headache, general malaise, nausea, chills
There was no joint pain, no neck rigidity, no photophobia, no SOB
Working diagnosis = Upper respiratory tract infection (URI);
possible influenza
Lab workout: throat & nasal swab; CBC, blood culture
Management: antipyretic, analgesic, encourage fluids, education
on cough etiquette, hand hygiene
Patient discharge home and advised to see family doctor/return
to ED if symptoms worsened
Discharge (confirmed) diagnosis
= URI, possible influenza (clinical verification status)
Clinical status = active
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16. A simple clinical use case
Second encounter:
The next day, patient returned to ED with additional symptoms:
worsen headache, photophobia, nuchal rigidity, reddish purple
skin rash, photophobia, irritability, mild delirium
Diff/diagnosis: bacterial meningitis; viral encephalitis (verification status)
Lab workout results:
Throat + nasal swab: N meningitidis
Blood + CSF: N meningitidis, serogroup A
Confirmed diagnosis = meningococcal meningitis (verification status)
Clinical status = active
Refuted diagnosis = influenza; viral encephalitis (verification status)
Management: admit + antibiotics; discharged after 5 days
Discharge (Confirmed) diagnosis =
meningococcal meningitis (verification status)
Clinical status = resolved
* Blood culture is used in cases with difficulty/high risk in lumbar puncture
(October 3, 2011)
There is surely a subgroup of patients (especially young ones) in whom the benefit:harm balance of CT comes out in favour of NOT doing the imaging. In these cases, getting the scan is not ‘defensive medicine’ but ‘offensive medicine’ – offending the principle of primum non nocere. During ED shifts I have recently had to perform online searches in order furnish colleagues and patients’ medically qualified relatives with printouts of the literature on this. This page is here to save me having to repeat those searches.
Regarding the practice of performing a routine head CT prior to lumbar puncture to rule out risk of herniation:
Mass effect on CT does not predict herniation
Lack of mass effect on CT does not rule out raised ICP or herniation
Herniation has occurred in patients who did not undergoing lumbar puncture because of CT findings
Clinical predictors of raised ICP are more reliable than CT findings
CT may delay diagnosis and treatment of meningitis
Even in patients in whom LP may be considered contraindicated (cerebral abscess, mass effect on CT), complications from LP were rare in several studies
Best practice, it would seem, is the following
If you think CT will show a cause for the headache, do a CT
If a CT is indicated for other reasons (depressed conscious level, focal neurology), do a CT
If a GCS 15 patient is to undergo LP for suspected (or to rule out) meningitis, and they have a normal neurological exam (including fundi), and are not elderly or immunosuppressed, there is no need to do a CT first.
If you’re seriously worried about meningitis and are intent on getting a CT prior to LP, don’t let the imaging delay antimicrobial therapy
Here are some useful references:
1. The CT doesn’t help CT head before lumbar puncture in suspected meningitis BestBET evidence summary: In cases of suspected meningitis it is very unlikely that patients without clinical risk factors (immunocompromise/ history of CNS disease/seizures) or positive neurological findings will have a contraindication to lumbar puncture on their CT scan If CT scan is deemed to be necessary, administration of antibiotics should not be delayed.  BestBETS website
Computed Tomography of the Head before Lumbar Puncture in Adults with Suspected Meningitis Much cited NEJM paper from 2001 which concludes: “In adults with suspected meningitis, clinical features can be used to identify those who are unlikely to have abnormal findings on CT of the head“ N Engl J Med Dec 13;345(24): Full Text
Cranial CT before Lumbar Puncture in Suspected Meningitis  Correspondence in 2002 NEJM including study of 75 patients with pneumococcal meningitis: CT cannot rule out risk of herniation Cranial CT before Lumbar Puncture in Suspected Meningitis N Engl J Med Apr 18;346(16): Full Text
3. Guidelines say CT is not always needed: National (UK) guidelines on meningitis (community acquired meningitis in the immunocompetent host) available from meningitis.org. This PDF poster clearly outlines limitations of head CT,
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17. Recommendations
Review and recommend how to use without causing confusion:
Allergy Status template and Problem Status template
Review clinical status value set to include:
Active; Inactive; Inactive Carrier; Resolved
Remission states (e.g. partial, full …)
Relapse states
(Note – the review should consider other clinical status values, e.g.: exacerbation, pseudoexacerbation, refractory …)
Review/update C-CDA templates and guidelines to implement verification status values
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18. Next step?
Use cases
Analyse allergy status and problem status observation templates
Update where appropriate, necessary
Review, develop, approve new clinical status and verification status value sets
Develop guidelines on how to use these status value sets with Act Status values
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