ARCHETYPE ICHOM LPC Complication (openEHR-EHR-OBSERVATION.ichom_lpc_complications.v0)

Name: ICHOM LPC Complication
License: http://creativecommons.org/licenses/by-sa/3.0/

ARCHETYPE ID	openEHR-EHR-OBSERVATION.ichom_lpc_complications.v0
Concept	ICHOM LPC Complication
Description	Acute complications of treatment.
Use	For use in ICHOM LPC dataset to capture details of acute complications of treatment.
Purpose	Local archetype to capture acute complications of treatment, such as Clavien grade and CTCAE grade.
References
Copyright	© Clinical Models UK
Authors	Author name: Hildegard Franke Organisation: freshEHR Clinical Informatics Ltd. Email: hildi@freshehr.com Date originally authored: 2016-08-08
Other Details Language	Author name: Hildegard Franke Organisation: freshEHR Clinical Informatics Ltd. Email: hildi@freshehr.com Date originally authored: 2016-08-08
OtherDetails Language Independent	{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 3.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/., custodian_organisation=UK Clinical Models, current_contact=Hildegard Franke, freshEHR Clinical Informatics Ltd., original_namespace=uk.org.clinicalmodels, original_publisher=UK Clinical Models, custodian_namespace=uk.org.clinicalmodels, MD5-CAM-1.0.1=39793F9A6BE6E916077821384644B121, build_uid=2099b598-3a1d-4b58-a061-00bc448e41a0, revision=0.0.1-alpha}
Keywords	complication, clavien, ICHOM, prostate, cancer
Lifecycle	in_development
UID	f80cfa89-3987-4f84-9e65-6bdc3721c671
Language used	en
Citeable Identifier	1051.32.420
Revision Number	0.0.1-alpha
All	Archetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Acute complications of treatment., archetypeConceptComment=null, otherContributors=, originalLanguage=en, translators=, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={content=[], description=[], details=[], source=[], capabilities=[], other_participations=[], protocol=[ResourceSimplifiedHierarchyItem [path=/protocol[at0032]/items[at0033], code=at0033, itemType=SLOT, level=2, text=Extension, description=Additional information required to capture local context or to align with other reference models/formalisms., comment=e.g. Local hospital departmental infomation or additional metadata to align with HL7 or CDISC equivalents., uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:* All not explicitly excluded archetypes, extendedValues=null]], provider=[], activities=[], state=[], events=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002], code=at0002, itemType=POINT_EVENT, level=2, text=Point in time, description=A specific date and/or time which may be explicitly defined in a template or at run-time., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=POINT_EVENT, bindings=null, values=null, extendedValues=null]], ism_transition=[], data=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0004], code=at0004, itemType=ELEMENT, level=4, text=Clavien complication, description=Indication whether patient experienced a Clavien grade III-V complication., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=C_DV_ORDINAL, bindings=null, values=0: at0005::No [Patient did not experience Grade 3 or 4 complication.] 1: at0006::Yes, Grade 3 [Patient experienced Grade 3 complication.] 2: at0007::Yes, Grade 4 [Patient experienced Grade 4 complication.] , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0008], code=at0008, itemType=ELEMENT, level=4, text=CTCAE Grade 3 or 4 complication, description=Indication whether the patient experienced a CTCAE grade 3 or 4 complication during treatment with radiation therapy or within the first 6 months following the completion of radiation therapy., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0010], code=at0010, itemType=ELEMENT, level=4, text=CTCAE domain and grade, description=Statement about CTCAE domain and grade experienced during radiation therapy., comment=null, uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values= at0011::0 = No grade 3 or 4 toxicity [Patient has not experienced grade 3 or 4 toxicity.] at0012::1 = Fatigue grade 3 [Patient has experienced grade 3 fatigue.] at0013::2 = Fatigue grade 4 [Patient has experienced grade 4 fatigue.] at0014::3 = Dermatitis grade 3 [Patient has experienced grade 3 dermatitis.] at0015::4 = Dermatitis grade 4 [Patient has experienced grade 4 dermatitis.] at0016::5 = Diarrhea grade 3 [Patient has experienced grade 3 diarrhoea.] at0017::6 = Diarrhea grade 4 [Patient has experienced grade 4 diarrhoea.] at0018::7 = Abdominal pain grade 3 [Patient has experienced grade 3 abdominal pain.] at0019::8 = Abdominal pain grade 4 [Patient has experienced grade 4 abdominal pain.] at0020::9 = Rectal mucositis grade 3 [Patient has experienced grade 3 rectal mucositis.] at0021::10 = Rectal mucositis grade 4 [Patient has experienced grade 4 rectal mucositis.] at0022::11 = Proctitis grade 3 [Patient has experienced grade 3 proctitis.] at0023::12 = Proctitis grade 4 [Patient has experienced grade 4 proctitis.] at0024::13 = Hot flashes grade 3 [Patient has experienced grade 3 hot flushes.] at0025::14 = Hot flashes grade 4 [Patient has experienced grade 5 hot flushes.] at0026::15 = Cystitis non-infective grade 3 [Patient has experienced grade 3 non-infective cystitis.] at0027::16 = Cystitis non-infective grade 4 [Patient has experienced grade 4 non-infective cystitis.] at0028::17 = Urinary retention grade 3 [Patient has experienced grade 3 urinary retention.] at0029::18 = Urinary retention grade 4 [Patient has experienced grade 4 urinary retention.] at0030::19 = Other grade 3 (free text) [Patient has experienced other grade 3.] at0031::20 = Other grade 4 (free text) [Patient has experienced other grade 4.] , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0009], code=at0009, itemType=SLOT, level=4, text=CTCAE domain and grade, description=Statement of CTCAE domain and grade if complication was experienced., comment=The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Fatigue - Grade 1: Fatigue relieved by rest - Grade 2: Fatigue not relieved by rest; limiting instrumental ADL - Grade 3: Fatigue not relieved by rest, limiting self care ADL - Grade 4: N/A Dermatitis radiation - Grade 1: Faint erythema or dry desquamation - Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema - Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion - Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated Diarrhea - Grade 1: Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline - Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline - Grade 3: Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated Abdominal pain - Grade 1: Mild pain - Grade 2: Moderate pain; limiting instrumental ADL - Grade 3: Severe pain; limiting self care ADL - Grade 4: N/A Rectal mucositis - Grade 1: Asymptomatic or mild symptoms; intervention not indicated - Grade 2: Symptomatic; medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: Life-threatening consequences; urgent operative intervention indicated Proctitis - Grade 1: Rectal discomfort, intervention not indicated - Grade 2: Symptoms (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; fecal urgency or stool incontinence; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated Hot flashes - Grade 1: Mild symptoms; intervention not indicated - Grade 2: Moderate symptoms; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: N/A Cystitis non-infective - Grade 1: Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence - Grade 2: Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL - Grade 3: Gross hematuria; transfusion, IV medications or hospitalization indicated; elective endoscopic, radiologic or operative intervention indicated - Grade 4: Life-threatening consequences; urgent radiologic or operative intervention indicated Urinary retention - Grade 1: Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual - Grade 2: Placement of urinary, suprapubic or intermittent catheter placement indicated; medication indicated - Grade 3: Elective operative or radiologic intervention indicated; substantial loss of affected kidney function or mass - Grade 4: Life-threatening consequences; organ failure; urgent operative intervention indicated., uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, 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