C-CDA: Problem/Allergy Problem Status Observation Templates and Clinical Status Post Madrid WGM update 2017-05 Stephen Chu, PCWG co-chair Emma Jones, PCWG co-chair Rob Hausam, PCWG vocab facilitator Lisa Nelson, PCWG Liaison from SDWG

Background CDA r2.0 IG C-CDA CLINNOTES R2.1Vol1 November 2014, p.19 11/10/2018

Background CDA r2.0 IG C-CDA CLINNOTES R2.1Vol1 November 2014, p.19 11/10/2018

Background CDA r2.0 IG C-CDA CLINNOTES R2.1Vol1 November 2014, p.19, 20 11/10/2018

Background CDA r2.0 IG C-CDA CLINNOTES R2.1Vol1 November 2014, p.19, 20 11/10/2018

Background CDA r2.0 IG C-CDA CLINNOTES R2.1deprecated two clinical status related templates: Allergy status observation (Vol1, p.49) Problem status (Vol1, p.53) 11/10/2018

What are the problems? Given that it has been argued that the statusCode “reflects the state of the activity”, i.e. the observation itself, and “not the status of what is being observed”, e.g. the clinical status itself It is unclear how it can then argue that the statusCode of the Problem Concern Act is the “definitive indication of the status of the concern” i.e the “what is being observed”? 11/10/2018

What are the problems? inadequate for expressing the rich semantics clinical status of the problem or concern statusCode: Metadata (document property) Not displayed as human readable data. How is that useful for expressing clinical status? Using “statusCode + effectiveTime to communicate “status”: inadequate

What are the problems? In the absence of these templates, “problem concern status” is represented by “statusCode” + effectiveTime: The statusCode of the Problem Concern Observation is the definitive indication of the status of the concern Issues Status of the concern = status of the Act (workflow status) “isDocumentProperty” of statusCode is supposed to = true (hence it is a document property, not a clinical property) ≠ rich semantics of clinical status of the problem/concern research on the RIM indicates that the statusCode does not carry meaning that would be present in the human readable narrative The effectiveTime of the Problem Observation is the definitive indication of whether or not the underlying condition is resolved 11/10/2018

What are the problems? statusCode values represent workflow / object states Extract from a “Life Cycle and Object State Transition” document published on 4 April 2011: Under the rules set out in the HL7 RIM, classes have statusCodes, which means that an object (i.e. an instance of a class) may have a defined state At any time an object with a defined state machine has a specified state drawn from a fixed repertoire of states defined for its class. The state of the object is changed by events that act on the object; each event is drawn from a fixed repertoire of events defined for its class and has an associated rule specifying the new state of the object given the state of the object at the time of the event 11/10/2018

What are the problems? These workflow/object state transition values are inadequate and inappropriate for representing the complex clinical status 11/10/2018

Deprecation: result of a technical misunderstanding? The deprecation of the two templates may be considered a technical confusion of the ACT of observation (ACT.statusCode) and what is being observed (the clinical status values) The use of statusCode + effectiveTime is clearly inappropriate and inadequate for representing clinical status 11/10/2018

Un-deprecate the Allergy/Intolerance and Problem Status templates Previous discussions between PCWG and SDWG have reached agreement that: The semantic complexity requires the reinstatement of: Problem status template Allergy status observation template If it can be agreed that the deprecation was a result of technical confusion Can these two templates be un-deprecated through an errata process? 11/10/2018

Clinical status value sets: the current state The status of most clinical problems or conditions need to be represented by a set of clinical status specific values: Active Controlled Well controlled Poorly controlled Stabilized Refractory (??? Use pre-coordination, e.g. refractory schizophrenia) Relapse Recurrence Inactive Remission Resolved FHIR Condition.clinicalStatus code values FHIR Change Requests #13025 2017-03-16 PCWG FHIR Conference call: Added “relapse” as a child of “active” FHIR Change Requests #13026 2017-03-23 PCWG-FHIR call: Added “controlled” and “poorly controlled” 11/10/2018

Clinical status value sets: the current state The clinical status of Allergy/Intolerance need to be represented by a set of clinical status specific values: Active Inactive Resolved Why the value sets for Condition and Allergy/Intolerance are different? Condition is a present or past state.  Allergy/intolerance is a propensity to future reaction They (condition and allergy/intolerance) do not have the same or even analogous clinical status value sets FHIR Allergy/Intolerance.clinicalStatus code values 11/10/2018

Clinical status value set Definitions: Active – The subject is currently experiencing the symptoms of the condition or there is evidence of the condition Well controlled – The subject's condition is adequately or well managed such that the recommended evidence-based clinical outcome targets are met Poorly controlled – The subject's condition is inadequately/poorly managed such that the recommended evidence-based clinical outcome targets are not met Recurrence – the subject is experiencing a re-occurrence or repeating of a previously resolved condition Example: recurrence of (previously resolved) urinary tract infection, pancreatitis, cholangitis, conjunctivitis Relapse – the subject is experiencing a return of a condition, or signs and symptoms after a period of improvement or remission Examples: relapse of cancer, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, bipolar disorder, [psychotic relapse of] schizophrenia, etc Inactive – The subject is no longer experiencing the symptoms of the condition or there is no longer evidence of the condition Remission – The subject is no longer experiencing the symptoms of the condition, but there is a risk of the symptoms or condition returning Resolved – The subject is no longer experiencing the symptoms of the condition and there is a negligible perceived risk of the symptoms returning 11/10/2018

Suggested action (1) Reinstate the deprecated C-CDA templates: The “Allergy Status Observation” template should be renamed to “Allergy/Intolerance Clinical Status Observation” The “Problem Status” template should be renamed to “Problem Clinical Status Observation” to be consistent 11/10/2018

Suggested action (2) Observation.code values needed for Allergy/Intolerance Observation template Both Allergy Status Observation and Problem Status templates use same LOINC code: 3399-4 11/10/2018

Suggested action (2) Observation.code values needed for these two templates Both Allergy Status Observation and Problem Status Templates use same LOINC code: 3399-4 11/10/2018

Suggested action (3) Use FHIR clinical status value sets for Allergy/Intolerance and Problem Clinical Status observation.value slot 11/10/2018

Suggested action (3) Problem clinical status values 11/10/2018

Suggested action (3) Allergy/Intolerance clinical status values 11/10/2018

Further discussions 11/10/2018

Allergy Problem Observation in C-CDA 1.1 11/10/2018

Allergy Status Observation in C-CDA 1.1 Table 126: Allergy Status Observation 11/10/2018

Problem Observation in C-CDA 1.1 The “Problem Status” Observation uses the same HITSPProblemStatus values 11/10/2018

In C-CDA 2.0 Allergy Status Observation and Problem Status templates are deprecated 11/10/2018

In C-CDA 2.0 Allergy Status Observation and Problem Status templates are deprecated 11/10/2018

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