SNOMED CT Content Improvement Project Elaboration phase Project ID: artf6262 Topic: Allergic state - Immune hypersensitivity disorder Date 2012-12-04 Version 2.3 Amendment History Version Date Editor Comments 0.01 20111109 Bruce Goldberg First draft for comments 1.0 20120222 Bruce Goldberg Second draft 1.1 20120318 Bruce Goldberg Third draft revisions including metrics 1.2 20120325 Bruce Goldberg Fourth draft revisions 2.0 20120730 Bruce Goldberg Final revisions 2.1 20120808 Bruce Goldberg 2.2 20120822 Bruce Goldberg 2.3 20121204 Bruce Goldberg Retirement of Immune hypersensitivity disorder with replacement by allergic condition Addition of new qualifier values for defining hypersensitivity condition, allergic condition and allergic sensitization Change to concept model for allergic disposition involving substitution of “after” attribute for “has manifestation” and role grouping after allergic sensitization with causative agent x to represent allergy to x concepts Additional edits including discussion of propensity to adverse reactions to substance Further refinement of allergy definitions Review Timetable Review date Responsible owner Comments YYYYMMDD Person/group responsible Summary of action (remove or add rows if necessary) © International Health Terminology Standards Development Organisation 2012. 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Elaboration phase Page 2 of 22 Table of Contents 1 Glossary ................................................................................................................................ 4 1.1 Domain Terms............................................................................................................................. 4 2 Introduction............................................................................................................................ 5 2.1 Purpose....................................................................................................................................... 5 2.2 Audience and stakeholder domain .............................................................................................. 5 3 Solution Development ........................................................................................................... 7 3.1 Initial Design ............................................................................................................................... 7 3.2 Iteration One ............................................................................................................................. 15 3.3 Iteration Two .. .......................................................................................................................... 16 4 Recommendation ................................................................................................................ 17 5 Quality program criteria ....................................................................................................... 18 5.1 Quality metrics .......................................................................................................................... 18 5.2 Use case scenarios ................................................................................................................... 19 5.3 Test cases................................................................................................................................. 19 6 Updated Project Resource Estimates .................................................................................. 20 6.1 Scope of construction phase ..................................................................................................... 20 6.2 Expected project resource requirement category ...................................................................... 20 6.3 Projection of remaining overall project resource requirements .................................................. 20 7 APPENDIX .......................................................................................................................... 21 7.1 Formal ontological model of allergy conditions .......................................................................... 21 Elaboration phase Page 3 of 22 1 Glossary 1.1 Domain Terms Hypersensitivity (general) Hypersensitivity condition Hypersensitivity reaction Allergy1 (general) Allergic condition Allergic disposition Allergic reaction Allergic sensitization Objectively reproducible symptoms or signs initiated by exposure to a defined stimulus at a dose tolerated by normal persons The disposition to develop hypersensitivity or the manifestation of a such disposition A pathological process initiated by exposure to a defined stimulus at a dose tolerated by normal persons. It may be the manifestation of a disposition to hypersensitivity. Allergy is a type of immune-mediated hypersensitivity in which the immune response is generally directed towards a foreign antigen and which results in tissue injury, which is usually transient. The disposition to develop an allergic reaction, the allergic reaction itself or it’s consequences The disposition to develop an allergic reaction. Synonym “allergy”, “allergic disposition” A pathological immune process generally directed towards a foreign antigen, which results in tissue injury which is usually transient. It is the manifestation of the allergic state. It is most often applied to type I hypersensitivity but other hypersensitivity types especially type IV (e.g. allergic contact dermatitis) may be involved A process characterized by a humoral or cell-mediated immune response to a foreign antigen resulting in the production of specific antibodies and/or immune cells which may then lead to an allergic disposition. An allergic disposition requires the presence of a sensitized state but a sensitized state does not necessarily lead to an allergic disposition. Allergic sensitization may also refer to the persistent state of specific antibody/immune cell presence following an allergic sensitization process Qualifier value definitions for pathological process role Hypersensitivity process Allergic process Allergic sensitization process 1 A pathological process that results in a hypersensitivity process or disposition A type of immune hypersensitivity process that results in an allergic disposition or process. A type of allergic process that results in an allergic sensitization process or sensitized state Revision of 2003 EAACI/WAO definition of allergy Elaboration phase Page 4 of 22 2 Introduction 2.1 Purpose The purpose of this project is to consider further review of the Allergic state and Immune hypersensitivity disorder hierarchies. The merger of allergic disorder" with "immune hypersensitivity disorder" had led Psoriasis and Graves disease to be classified as allergic disorders. The definition of allergic/immune hypersensitivity disorder will need to be revised in order to distinguish autoimmune from allergic disorders. In addition, the relationship between allergic disorders, states and reactions needs additional review. SNOMED CT projects transition from Inception Phase Elaboration Phase Construction Phase Transition Phase. This document describes the Elaboration Phase. It follows on from an Inception Phase report, which describes the detail of the problem to be addressed and its scope boundaries The purpose of the Elaboration Phase document(s) is to document one (or more) possible technical solutions that have been developed and tested, and to recommend and provide a detailed specification of a preferred solution to be taken forward to the construction phase. 2.2 Audience and stakeholder domain The audience for this document includes all standards terminology leaders, implementers and users developing core and extension content in the clinical finding/disorder hierarchy but is especially targeted at those with an interest in documenting adverse reactions. A further significant audience is the community of SNOMED authors that may be requested to implement the recommended specification. 2.2.1 Stakeholders The National Cancer Institute (Common Terminology Criteria for Adverse Events, CTCAE) Medical Dictionary for Regulatory Activities (MedDRA) National Health Service (NHS), United Kingdom ([email protected]) IHE Strategic Development Medication Management Subcommittee World Health Organization European Academy of Allergy and Clinical Immunology (EAACI) the World Allergy Organization (WAO). American Academy of Asthma, Allergy and Immunology American College of Asthma, Allergy and Immunology Content developers and end-users (clinical allergists, immunologists, dermatologists, pulmonologists otolaryngologists and rheumatologists). HL-7 patient care work group Elaboration phase Page 5 of 22 A copy of this document has been sent to members of the Care plan, HL7 Patient Care Work Group (André Boudreau, Elaine Ayres , Stephen Chu) for comment. “After reading through your v3.0 document, I would like to suggest that the scope include the SCT concepts related to intolerance and to propensity”. André Boudreau Co-Lead, Care plan, HL7 Patient Care Work Group Chair, Individual Care pan Canadian Standards Collaborative Working Group Elaboration phase Page 6 of 22 3 Solution Development 3.1 Initial Design 3.1.1 Outline of initial design The design of this project is based on the following criteria 1. Creation of a text definition that distinguishes allergic disorders from other types of immunologically-mediated hypersensitivity such as autoimmunity by refining the EAACI/WAO definitions. This is the background behind the original request. 2. Creation of text definitions for 106190000, allergic state (disorder) and 418925002 immune hypersensitivity reaction (disorder) 3. Reorganizing the three hierarchies noted above in consideration of the revised definitions. 4. Improving the concept models for allergic disorder, allergic state and allergic reaction using a formal ontological approach in order to clearly represent the associations between them. As this project consists of several components, the logical approach would be to divide the project into individual tasks in order of increasing complexity. Phase 1: In order to accomplish the successive phases of this project, one must consider the overall approach taken which incorporates the ideas described by Schulz et. al. in which clinical findings and disorders can be reimagined as pathological structures, dispositions or processes and their disjunction, conditions (SDP)2. With this in mind, 106190000, allergic state (including allergy to x) may be considered a pathological disposition while 418925002, immune hypersensitivity reaction (allergic reaction) a pathological process. The concepts residing under 421668005, immune hypersensitivity disorder (allergic disorder) are ambiguous as to whether they represent pathological dispositions or processes and therefore would be considered to be conditions3. The initial stages of this project would call for the retirement of Immune hypersensitivity disorder and 421976005, hypersensitivity disorder with replacement by 2 new terms, hypersensitivity condition and allergic condition. The notion of an immune hypersensitivity condition as distinct from an allergic condition would be eliminated. Allergic condition would be assigned parents of disorder of immune function4 and hypersensitivity condition 2 Stefan Schulz, Kent Spackman, Andrew James, Cristian Cocos and Martin Boeker J Biomed Semantics 2 Suppl 2():S6 (2011) PMID 21624161 3 Allergic diseases such allergic rhinitis could be interpreted as dispositions in the absence of the relevant allergen or as processes (allergic reactions) after exposure to the allergen. 4 Due to the weak definition of 414029004, Disorder of immune function (disorder) using has definitional manifestation immune system finding, it has been decided to not add this concept as a parent of allergic condition. Elaboration phase Page 7 of 22 and defined as a pathological immune process or the disposition to undergo such a process usually to an external agent. Changes to the concept model of Allergic conditions Currently, Immune hypersensitivity disorder (allergic disorder) is fully defined as: Is A Disease Due to Immune hypersensitivity reaction (allergic reaction). This definition appears to be suboptimal. The proposal is to redefine hypersensitivity and allergic conditions using the pathological process role analogous to autoimmune and infectious disorders with which these share similarities in not being able to be represented by the associated morphology attribute or an abnormal structure. This would require the reorganization as well as creation of several additional qualifier values under pathological process (qualifier value) as shown below: Pathological process (qualifier value) autoimmune (qualifier value) hypersensitivity (qualifier value)5 allergic process (qualifier value) sensitization (qualifier value) Hypersensitivity condition would thus be completely defined as6: |disease| |pathological process|=|hypersensitivity| and allergic condition as: |hypersensitivity condition| |pathological process|=|allergic process| The current children of immune hypersensitivity disorder would be moved under Allergic condition. Phase 2: In the second phase of this project, immune hypersensitivity reaction would be retired and 419076005, allergic reaction unretired as its replacement. The allergic reaction hierarchy would be added under allergic condition thus defining allergic reaction as a hypersensitivity reaction and an allergic condition. There are several concepts residing under the current immune hypersensitivity reaction hierarchy that represent specific types of immune (not necessarily allergic) reactions represented by the Gell and Coomb’s classification and are used to define the associated disorders. These can be aggregated under a new concept, immune hypersensitivity reaction by mechanism analogous to immune hypersensitivity disorder by mechanism which would represent the five types of 5 Currently a child of mechanisms (qualifier value) 6 The attribute value pairs |due to|=hypersensitivity reaction and |due to|=immune hypersensitivity reaction from the original definitions of hypersensitivity disorder and immune hypersensitivity disorder respectively will not be included in the new definitions of hypersensitivity condition and allergic condition. Elaboration phase Page 8 of 22 hypersensitivity reactions as decribed by Gell and Coombs. 106190000, allergic state (disorder) is currently primitive with no defining attributes and a single parent, 420134006, propensity to adverse reactions. Allergic state would be added under allergic condition thus helping to define the former. Allergic state has a child, allergic disorder by allergen type. Allergic state would be removed as a parent of allergic disorder by allergen type which would thus become a subtype only of allergic condition and can be used to aggregate terms of the type allergic condition (disorder) x to allergen y (i.e. 449729000, allergic rhinitis due to house dust mite). The children currently residing under allergic disorder by allergen type are the following: Allergy to gauze Allergy to plant Allergy to substance House dust mite allergy Tape allergy Allergy to substance would be made a child of allergic state and the remaining terms would be merged under allergy to substance. Text definitions would be created for allergy to gauze, allergy to plant, house dust mite allergy and tape allergy to indicate that the allergy is to the substance derived from these physical objects and organisms. Changes to the concept model of allergic state (allergy) Allergy to various substances is presently defined using the causative agent role implying that the allergy (disposition) is caused by the allergen. In actuality, the allergen causes the allergic reaction which is the realization of the allergic disposition. In order to link the allergen to the disposition without invoking a causative relation between the allergen and the disposition, a new concept of allergic sensitization would be created. Allergic sensitization would be defined as the process or state induced by a humoral or cell-mediated immune response to a foreign antigen characterized by the presence of specific antibodies and/or immune cells and would be represented in SNOMED as a subtype of allergic condition with pathological process sensitization. It is believed that the process or state of sensitization to a particular allergen would necessarily precede the disposition which could then be realized as an allergic reaction upon re-exposure to that allergen. Allergy (disposition) would thus be defined as: |allergic disposition| |allergic condition| |propensity to adverse reactions|, |after|=|allergic sensitization| As the specific allergen causes the sensitization, allergy to x can be defined using the after and causative agent roles in a role group as illustrated: allergy to penicillin |allergy to drug|: {|after|=|allergic sensitization|, |Causative agent|=|penicillin|} Elaboration phase Page 9 of 22 Further scrutiny of propensity to adverse reactions to substance (disorder) reveals that it is modeled with causative agent substance. This is analogous to the issue of allergy to substance, in that the substance does not cause the propensity (disposition). This would be problematic in terms of the proposed definition of allergic disposition being a subtype of propensity to adverse reactions to substance (disorder). Examining the children of Propensity to adverse reactions to substance, it appears that the majority are in fact just allergies to substance as shown below. It would therefore be desirable to retire Propensity to adverse reactions to substance as maybe A allergy to substance while moving most of its children under allergy to substance. The relatively few non-allergy terms will need to be moved under hypersensitivity condition for now but may eventually need to reside under a new class of hypersensitivity disposition There is a significant degree of misclassification of terms in all 3 allergy-related hierarchies stemming not only from unclear definitions of these conditions but also the use of common names that falsely imply allergy as well as a lack of understanding of the immune mechanisms underlying some of the concepts. These issues will also be addressed in phase 2. Elaboration phase Page 10 of 22 Phase 3: The final phase of this project can be considered for future implementation as it may have a more global impact on SNOMED. Thought should be given to creation of three top level nodes under disease or clinical findings (TBD) for pathological structure, pathological disposition and pathological manifestation (process). Specific concepts in which the FSN clearly implies a pathological structure, disposition or manifestation can be added under these organizing nodes. As an example, propensity to adverse reactions and allergic state have an implict meaning of disposition whereas hypersensitivity reaction and allergic reaction have an implicit meaning of a manifestation or process. Lastly, consideration can be given to further expanding the hypersensitivity qualifier value hierarchy by including hypersensitivity types7 and its children type I hypersensitivity and type IV hypersensitivity under hypersensitivity (qualifier value) with the addition of types I, II, III and V in order to refine the definitions of those hypersensitivity conditions found under immune hypersensitivity disorder/reaction by mechanism. Pathological process (qualifier value) Autoimmune (qualifier value) Hypersensitivity (qualifier value) Hypersensitivity types (qualifier value) Type I hypersensitivity (qualifier value) Type II hypersensitivity (qualifier value) Type III hypersensitivity (qualifier value) Type IV hypersensitivity (qualifier value) Type IV hypersensitivity (qualifier value) Allergic process (qualifier value) Type I hypersensitivity (qualifier value) Sensitization (qualifier value) The resulting reorganization and concept model for allergic conditions are illustrated below: 7 Currently a child of types (qualifier value) Elaboration phase Page 11 of 22 Autoimmune disorder Pathological process Autoimmun e Is A Disease Disorder of immune function Is A Pathological process Is A Disease Is A Hypersensit ivity Is A Is A Hypersensitivity condition After Is A Is A Allergy Is A Hypersensitivity reaction Allergic sensitization Is A Is A Adverse reaction Propensity to adverse reactions Allergic rhinitis Is A Allergy to substance RG Causative agent Allergic condition Substance after Is A Pathological process Is A Pathological process Is A Complication Allergic sensitization Sensitizatio n Qualifier value hierarchy Qualifier value Allergy Is A Allergic reaction Is A Patholo gical process Allergic reaction to substance Autoim mune Is A Hyperse nsitivity Causative agent Allergy Substance Sensitiz ation 3.1.2 Significant design or implementation decisions / compromises The design of this project is based on the ontology design pattern suggested by Schulz et.al. 2 in which pathological entities can be viewed as either pathological structures, dispositions or processes (SDP) with the ability to obscure these distinctions until required as for example at the time a diagnosis is being recorded. It is hoped that the design being proposed for allergy can be generalized to include other pathologic entities in which a distinction eventually needs to be made as to whether a clinical state represents a pathological structure disposition or process. A decision was also made to create a more robust concept model for allergic disorder (condition), allergic state and allergic reaction by Elaboration phase Page 12 of 22 including the pathological process attribute similar to the model developed for infections. Finally, the concept model for allergy to substance was further refined via a role group incorporating has definitional manifestation allergic sensitization and causative agent some allergenic substance. It is believed that this approach is more scientifically and ontologically correct than the current definition of allergy to substance in which the allergen appears to directly cause the allergy (disposition). While much of the above changes may be implemented through batch edits, there will need to be a significant amount of manual review of all three hierarchies in order to correct inconsistencies based on unclear definitions of some concepts, the use of common names that falsely imply allergy and the assignment of incorrect immune mechanisms as previously alluded to. Some of these issues are illustrated below: Concept Jones-Mote type hypersensitivity Hypersensitivity angiitis Anaphylactoid glomerulonephritis Allergic encephalitis Conjunctivitis associated with autoimmune skin disorder Humoral immunologic aplastic anemia Allergic rhinitis due to grass pollens (tree pollens/weed pollens) Anaphylactoid reaction Non-steroidal anti-inflammatory drug allergy Postinfective Henoch-Schönlein purpura Issue 1. Implies a disposition but meaning but should be a process. 2. Currently a child of allergic state but is a actually a type of delayed type hypersensitivity Currently a descendant of allergic disorder by body site affected. Not allergic. Currently a descendant of allergic disorder by body site affected. Not allergic. Currently a descendant of allergic disorder by body site affected. Not allergic. Currently a descendant of allergic disorder by body site affected. Not allergic. Currently a descendant of allergic disorder by body site affected. Not allergic. Currently children of seasonal allergy but appear to be conditions Is a child of acute allergic reaction. Anaphylactoid reactions are kinds of nonallergic hypersensitivity reactions. This concept and its children most likely represent anaphylactoid sensitivity. Is a descendant of allergic disorder of skin. Not allergic. The proposed organization and model for allergic conditions is based on earlier efforts of the events, conditions and episodes project group in which a more formal ontological representation was constructed (see appendix). As that model required DL formalisms including universal restriction which are not currently supported by SNOMED as well as the introduction of several new attributes derived from BioTop, it was decided that a reasonable compromise could be attained using elements of the more formal ontological approach such as the inclusion of SDP while utilizing current SNOMED roles. Elaboration phase Page 13 of 22 3.1.3 Evaluation of Design Implementation of the proposed model for allergic conditions requires: 1. Creating text definitions for hypersensitivity and allergic condition, state (disposition) and reaction 2. Merging immune hypersensitivity disorder (allergic disorder), allergic state and immune hypersensitivity reaction (allergic reaction) into a single hierarchy called allergic condition while retiring immune hypersensitivity condition and moving its children under allergic condition. 3. Creation of two new qualifier values, allergic (process) and sensitization and perhaps moving the existing hypersensitivity (qualifier value) from mechanisms (qualifier value) to pathological process (qualifier value). 4. Addition of a new allergic condition concept “allergic sensitization” required for the definition of allergic state. 5. Using the pathological process role to define hypersensitivity condition, allergic condition, allergic state and allergic reaction 6. Using the after and causative agent roles in a role group to link the allergic sensitization to its causative allergen in order to better define the allergic state Current model hypersensitivity disorder |disease| |due to|=|hypersensitivity reaction| immune hypersensitivity disorder |hypersensitivity disorder| |due to|=|immune hypersensitivity reaction| allergic state |propensity to adverse reactions| allergy to substance |propensity to adverse reactions to substance| |allergic disorder by allergen type| |causative agent|=|substance| hypersensitivity reaction |adverse reaction| immune hypersensitivity reaction |hypersensitivity reaction| Proposed model hypersensitivity condition |disease| |pathological process|=|hypersensitivity| allergic condition |hypersensitivity condition |disorder of immune function| |pathological process|=|allergic process| allergic dipsosition |allergic condition| |after|=|allergic sensitization| |propensity to adverse reactions| allergy to substance |propensity to adverse reactions to substance| {|after|=|allergic sensitization|, |causative agent|=|substance|} hypersensitivity reaction |adverse reaction| |hypersensitivity condition| allergic reaction |hypersensitivity reaction| |allergic condition| These changes are expected be implemented with minimal impact on existing SNOMED content. The model will initially be evaluated in the testing environment (UAT bundle) to assess the impact of some of the modeling steps and to determine the extent of possible batch editing. Elaboration phase Page 14 of 22 3.1.3.1 Exceptions and Problems 1. The proposed model excludes pathological structures (the “S” in SDP) from consideration as there is some difficulty defining an “allergic” structure. 2. Most of the children being moved under allergic condition contain the word “disorder”in the FSN. Consideration should be made to renaming these. 3. The notion of an allergic condition as a truly disjoint class is currently not supported by the DL formalism used by SNOMED. 4. A significant amount of manual review will be required in order to insure that some of the existing content is classified correctly. 5. The addition of a top level “condition” node populated by subhierarchies of pathological structures, dispositions and processes will be deferred for a future implementation as it is expected that this will have a more global effect on existing SNOMED content. 6. There is still some uncertainty as to whether the condition class and its descendants should be a child of disease or of clinical finding. 3.1.3.2 Design Strengths The proposed design will result in a more robust model for allergy content with clear interrelationships between the three existing allergy hierarchies and a more scientifically and ontologically correct definition of the important allergy to substance class. Additional cleanup of the existing hierarchies will result in improved classification and therefore retrieval of this content. The design allows for the ambiguity expressed in the FSNs of allergic disorders as to whether they represent dispositions or processes. The true nature of these terms may be asserted at the time of documentation by adding a second parent such as pathological disposition or pathological process8 or by use of defining properties for each specialization class as illustrated below: Allergic rhinitis (currently active/continuing) Is A Allergic rhinitis (condition) Some role=some role=active/continuing Allergic rhinitis (disposition) is A Allergic Rhinitis (condition) Some role=propensity to develop symptomatic allergic rhinitis 3.1.3.3 Design Weakness Design weaknesses are discussed under section 3.1.3.1 Exceptions and Problems. 3.2 Iteration One 3.2.1 Outline of revised design Redesign the Solution Identify objectives of iteration, and the major changes to previous design Communicate the revised design 8 When such concepts are created under the proposed top level condition node as discussed. Elaboration phase Page 15 of 22 3.2.2 Significant design or implementation changes 3.2.3 Evaluation of Revised Design 3.2.3.1 Exceptions and Problems 3.2.3.2 Design Strengths 3.2.3.3 Design Weakness 3.2.3.4 Design Risks Description of risk Importance Mitigation plan 3.3 Iteration Two .. Elaboration phase Page 16 of 22 4 Recommendation 4.1.1 Detailed design final specification See phases 1-3 pages 7-8 and in particular the figures on page 9 and 10, which illustrate how the revised allergy hierarchies would appear after implementing the proposed solution. 4.1.2 Iteration plan Elaboration phase Page 17 of 22 5 Quality program criteria 5.1 Quality metrics 5.1.1 Quality metric 1 Component Characteristic and Description Hierarchy Char: Disambiguate immune hypersensitivity disorder from allergic disorder Metric Allergic disorder Target Result 100% is A Descr: Immune hypersensitivity disorder 5.1.2 Quality metric 2 Component Characteristic and Description Logic definitions of Char: Clarify relationship between Metric allergic disorder, allergic state is A disorder, Allergic and allergic reaction Pathologic structure or process reaction hierarchies Result Allergic disorder concepts in Allergic state and Allergic Target 90% Descr: hasOutcome of Allergic reaction Allergy to x is A Pathologic disposition 100% hasAgentOfRealization x Allergic reaction to x is A Allergic process isRealizationOf 100% Allergy to x hasOutcome(only) Allergic disorder Elaboration phase Page 18 of 22 5.2 Use case scenarios 5.2.1 Use case 1 Representation of Allergy to X i.e the disposition to developing an allergic reaction after exposure to allergen X 5.2.1.1 Fit with IHTSDO strategy 1B Problem list diagnosis 1D Allergy list 2A Medication / allergy management 5.2.2 Use case 2 Representation of specific allergic/immunologic disorders such as allergic rhinits 5.2.2.1 Fit with IHTSDO strategy 1B Problem list Diagnosis There are 29 diagnoses on the SNOMED CT core problem list that refer to allergy, anaphylaxis or hypersensitivity. Allergic rhinitis is the top 11th diagnosis. 2A Medication / allergy management Relevant for decision support algorithms involving medication management in allergic individuals. An example would be an alert regarding use of radiocontrast agents in those with a history of an atopic disorder. 5.2.3 Use case 3 Representation of specific allergic disorders caused by allergen X e.g. Allergic rhinitis due to pollen 5.2.3.1 Fit with IHTSDO strategy 1B Problem list diagnosis 1D Allergy list 2A Medication / allergy management 5.2.4 Use Case 4 Representation of Non-specified allergic reactions to allergen X such as allergic reaction to penicillin 5.2.4.1 Fit with IHTSDO strategy 1B Problem list diagnosis There is a need to distinguish an episode of an allergic reaction to a particular substance occurring at the time of an encounter from a disposition to an allergic reaction to a particular substance 5.2.5 Use Case 5 Representation of specific types of allergic reactions to allergen x such as anaphylactic reaction to penicillin 5.2.5.1 Fit with IHTSDO strategy 1B Problem list diagnosis 5.3 Test cases Elaboration phase Page 19 of 22 6 Updated Project Resource Estimates Estimate project size; Forecast project velocity and duration Evaluate risks; Establish costs and articulate value; Plan deployment; Outline project lifecycle 6.1 Scope of construction phase 6.1.1 Skills required Domain-specific knowledge of allergic and immune (including autoimmune) disorders would be desirable. 6.1.2 Preventing recurrence of problem Creating text definitions for allergic conditions and publishing clear modeling guidelines for allergic conditions in the SNOMED CT editorial guide will ensure prevention of reoccurrence. 6.1.3 Division of project into stages Due to the overall size of the project and limited resources available, it is recommended that the project be divided into discrete stages in order to begin delivering value to stakeholders in a timely manner as discussed on pages 7-9. 6.2 Expected project resource requirement category The project is large impacting up to 3,000 concepts residing among several hierarchies and as has been suggested by one reviewer could be tackled as part of an even larger effort to revise the approach to adverse reactions in general. It should be addressed in phases as previously discussed. 6.3 Projection of remaining overall project resource requirements 6.3.1 Expected project resource requirement category The project is large and as has been suggested by one reviewer could be tackled as part of a larger effort to revise the approach to adverse reactions. 6.3.2 Expected project impact and benefit The project impact is HIGH – significant improvement to a minority but high profile use case. The benefit is a consistent, rational approach to classifying allergic and other immune disorders. 6.3.3 Indicative resource estimates for construction, transition and maintenance: Construction and transition phase: Approximately 2,269 will need to be reviewed and many remodeled. Maintenance phase: 1600 new allergic reaction to x concepts potentially to be authored in first 3 years based on approximate number of existing allergy to x concepts. Elaboration phase Page 20 of 22 7 APPENDIX 7.1 Formal ontological model of allergy conditions hasLocus some Pathologic structure isA Allergic disorder isA *For delayed type hypersensitivity this could be Th1 memory T-cells Condition Pathologic structure or process isA Allergen-specific IgE* hasLocus some Immune system structure isOutcomeOf some hasLocus some bearerOf some hasOutcome only isA isA Pathologic disposition isA Allergic disposition Allergy to X hasAgentOfRealization isRealizationOf some hasAgent some Pathologic process isA Allergic process isA hasOutcome only Allergic reaction to X Ige-mediated allergic sensitization Allergen X hasAgent some isA isA Allergic sensitization BioTop Relation Definition Domains Ranges (object property) hasAgent A participant of a process, with the additional Processual entity condition that the component instance is causally active in the relevant process. Elaboration phase Page 21 of 22 hasOutcome participant which either Processual entity - a) comes into being during the process or - b) undergoes some change during the process and constitutes (one of) the main result(s) of the process outcomeOf Inverse of hasOutcome *hasAgentOfRealization A participant of a disposition that results in Processual entity Disposition the realization of a process isRealizationOf Something that occurs can be the realization Processual entity Disposition of a function, a disposition, or a role or Quality or Role hasLocus relates a place with an entity which occurs, Disposition ImmaterialPhysicalEntity inheres, or is part of it ImmaterialNonphysicalEntity MaterialEntity ImmaterialPhysicalEntity SpatialRegion MaterialEntity ProcessualEntity Quality Role SpatialRegion bearerOf Inverse relation of inheresIn. Relates an ImmaterialPhysicalEntity Disposition independent continuant to a dependent one MaterialEntity Function (e.g. quality, state, function, or disposition) SpatialRegion ImmaterialNonphysicalEntity Quality Role Elaboration phase Page 22 of 22
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