ARCHETYPE Medication safety event (openEHR-EHR-EVALUATION.medication_safety_event.v1)

ARCHETYPE IDopenEHR-EHR-EVALUATION.medication_safety_event.v1
ConceptMedication safety event
DescriptionSummary of a patient safety event associated with medication for reporting purposes.
PurposeTo record a summary of a patient safety event associated with medication for reporting purposes.
References
Copyright© openEHR Foundation
AuthorsAuthor name: Dr Ian McNicoll
Organisation: Ocean Informatics, UK
Email: ian.mcnicoll@oceaninformatics.com
Date originally authored: 25/06/2012
Other Details LanguageAuthor name: Dr Ian McNicoll
Organisation: Ocean Informatics, UK
Email: ian.mcnicoll@oceaninformatics.com
Date originally authored: 25/06/2012
OtherDetails Language Independent{MD5-CAM-1.0.1=DE77C8A5A958AD6D3C30B89716CBF495}
Keywords
LifecycleAuthorDraft
Language useden
Citeable Identifier1013.1.1866
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Summary of a patient safety event associated with medication for reporting purposes., archetypeConceptComment=null, otherContributors=Anže Droljc, Marand s.i.i, Slovenia, originalLanguage=en, translators=
  • Slovenian: ?

  • , subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={items=[], description=[], context=[], activities=[], identities=[], capabilities=[], provider=[], protocol=[], content=[], source=[], credentials=[], events=[], data=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0235], code=at0235, itemType=ELEMENT, level=2, text=Main event for case?, description=Is this the principal or main event recorded during the case?, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Allowed values: {true}, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Safety event type, description=The type of event reported., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    New constraint
    [*]

    Constraint binding:
    [SafetyEventType]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0003], code=at0003, itemType=ELEMENT, level=2, text=MEDRA classification, description=The category of event reported using MedDRA classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0004], code=at0004, itemType=ELEMENT, level=2, text=DateTime of event onset, description=The date and/or time that the adverse event took place., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0041], code=at0041, itemType=ELEMENT, level=2, text=Description of event, description=A narrative description of the medication safety event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233], code=at0233, itemType=CLUSTER, level=2, text=Cause of event, description=Details of the estimated cause of the event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233]/items[at0062], code=at0062, itemType=ELEMENT, level=3, text=Estimated cause of event, description=The reason suspected for this event occurring., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Verbal miscommunication [Verbal understanding]
    • Written miscomunication-Illegible handwritting [Written understanding]
    • Written miscomunication-Abbreviations [Illegible writing]
    • Written miscomunication-Non metric units of measurement [*]
    • Written miscomunication-Decimal point [*]
    • Misread or didnt read [*]
    • Misinterpretation of the order [*]
    • Sound-alike drug name [*]
    • Look-alike drug name [*]
    • Packaging-Inappropriate Packaging or Design [*]
    • Packing-Dosage form [*]
    • Packaging-Error due to similarity to another drug (colour, form, size) [*]
    • Packaging-Error due different strength [*]
    • Characteristics of the medicine [*]
    • Human factors-Lack of information/knowledge [*]
    • Work not accomplished [*]
    • Incomplete documentation [*]
    • Work overload, burn out syndrome [*]
    • Fatigue/Lack of sleep [*]
    • Confrontational or intimidating behaviour [*]
    • Control not carried out [*]
    • Inappropriate lighting [*]
    • Inappropriate temperature/humidity [*]
    • Frequent interuptions and distractions [*]
    • Lack of staff [*]
    • Other [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233]/items[at0234], code=at0234, itemType=ELEMENT, level=3, text=Comment, description=An additional comment on the estimated cause of the event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0020], code=at0020, itemType=ELEMENT, level=2, text=Related trigger, description=Triggers thought to be related to this safety event recorded using IHCI classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
    •  Coded Text
      • Transfusion of Blood or Use of Blood Products [**(en)]
      • Acute Dialysis [**(en)]
      • Positive Blood Culture [**(en)]
      • X-Ray or Doppler Studies for Emboli or Deep Vein Thrombosis [**(en)]
      • Decrease in Hemoglobin or Hematocrit of 25% or Greater [**(en)]
      • Patient Fall [**(en)]
      • Pressure Ulcers [**(en)]
      • Readmission within 30 Days [**(en)]
      • Restraint Use [**(en)]
      • Healthcare-Associated Infections [**(en)]
      • In-Hospital Stroke [**(en)]
      • Clostridium difficile Positive Stool [**(en)]
      • Partial Thromboplastin Time (PTT) Greater than 100 Seconds [**(en)]
      • International Normalized Ratio (INR) Greater than 6 [**(en)]
      • Glucose Less than 50 mg/dl [**(en)]
      • Rising BUN or Serum Creatinine Two Times (2x) over Baseline [**(en)]
      • Vitamin K Administration [**(en)]
      • Diphenhydramine (Benadryl) Administration [**(en)]
      • Romazicon (Flumazenil) Administration [**(en)]
      • Naloxone (Narcan) Administration [**(en)]
      • Anti-Emetic Administration [**(en)]
      • Over-Sedation/Hypotension [**(en)]
      • Abrupt Medication Stop [**(en)]
      • Intra- or Post-Operative Death [**(en)]
      • Mechanical Ventilation Greater than 24 Hours Post-Operatively [**(en)]
      • Intra-Operative Administration of Epinephrine, Norepinephrine, Naloxone, or Romazicon [**(en)]
      • Pneumonia Onset [**(en)]
      • Readmission to the Intensive Care Unit [**(en)]
      • Terbutaline Use [**(en)]
      • Platelet Count Less than 50,000 [**(en)]
      • Administration of Oxytocic Agents (such as oxytocin, methylergonovine, and 15-methyl-prostaglandin in the post-partum period) [**(en)]
      • Administration of General Anesthesia [**(en)]
      • Readmission to the ED within 48 Hours [**(en)]
      • Time in ED Greater than 6 Hours [**(en)]
      • Abnormal laboratory parameter [*]
      • Falsely abnormal laboratory parameter [*]
      • Unknown [**(en)]
      • No trigger [*]
    •  Text
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018], code=at0018, itemType=CLUSTER, level=2, text=Adverse effect, description=Details of one or more side effects., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345], code=at0345, itemType=CLUSTER, level=3, text=Reaction details, description=Details of reaction, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345]/items[at0021], code=at0021, itemType=ELEMENT, level=4, text=Reaction, description=Description of the side-effect reported or observed using MEDRA or ATC codes., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345]/items[at0346], code=at0346, itemType=ELEMENT, level=4, text=Comment, description=An additional comment on the Reaction details., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0108], code=at0108, itemType=ELEMENT, level=3, text=DateTime of reaction onset, description=The datetime at which the side effects began., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0222], code=at0222, itemType=ELEMENT, level=3, text=Severity, description=The severity of the reaction., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Low [*]
    • Medium [*]
    • High [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0022], code=at0022, itemType=ELEMENT, level=3, text=Liklihood of causation, description=An estimate of how likely the side-effects noted are due to the safety event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Low [*]
    • Medium [*]
    • High [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236], code=at0236, itemType=CLUSTER, level=3, text=Intervention details, description=Details of interventions., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347], code=at0347, itemType=CLUSTER, level=4, text=Intervention additional details, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347]/items[at0012], code=at0012, itemType=ELEMENT, level=5, text=Intervention, description=The clinical intervention undertaken to resolve or ameliorate the adverse effect, uses PCNE terminology., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Prescriber informed [**(en)]
    • Nurse informed/instructed [**(en)]
    • Dispensing rejected [**(en)]
    • Drug recalled from the ward [**(en)]
    • Dietary regime changed [**(en)]
    • Food supplement discontinued [**(en)]
    • Food supplement initiated [**(en)]
    • Reconstitution solvent changed [**(en)]
    • Diluent changed [**(en)]
    • Medical device (or change) suggested [*]
    • Drug changed [**(en)]
    • Dose increased [**(en)]
    • Dose decreased [**(en)]
    • Dosage form changed [**(en)]
    • Administration interval changed [**(en)]
    • Drug discontinued [**(en)]
    • Drug initiated [**(en)]
    • Drug administration rate changed [**(en)]
    • Route of administration changed [**(en)]
    • Resuscitation required [**(en)]
    • Heamodialysis required [**(en)]
    • Transplantation required [**(en)]
    • Transfusion required [**(en)]
    • Operating procedure required [**(en)]
    • Additional laboratory test(s) required [**(en)]
    • Physiotherapy required [**(en)]
    • Psychotherapy required [**(en)]
    • Error corrected [*]
    • Monitoring required [*]
    • Patient informed [*]
    • Other [**(en)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347]/items[at0348], code=at0348, itemType=ELEMENT, level=5, text=Comment, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0014], code=at0014, itemType=ELEMENT, level=4, text=Intervention result, description=The result(s) of any interventions undertaken, recorded using MEDRA classification subset., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • *Intervencija preprečila, da bi zaplet dosegel pacienta(en) [*(en)]
    • *Intervencija popolnoma odpravila posledice, ki jih je zaplet povzročil pacientu(en) [*(en)]
    • *Intervencija delno odpravila posledice, ki jih je zaplet povzročil pacientu(en) [*(en)]
    • *Intervencija ni odpravila posledic, ki jih je zaplet povzročil pacientu(en) [*(en)]
    • *Intervencija ni bila možna(en) [*(en)]
    • *Rezultat intervencije ni poznan(en) [*(en)]
    • *Zmanjšanje stroškov zdravljenja(en) [*(en)]
    • *Skrajšan čas hospitalizacije(en) [*(en)]
    • *Pacient je bil odpuščen(en) [*(en)]
    • *Izboljšana kvaliteta življenja(en) [*(en)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0353], code=at0353, itemType=ELEMENT, level=2, text=Side effect recurrence, description=This information is aplicable when at least one Intervention is Dose decreased or Drug discontinued, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Yes [*]
    • No [*]
    • NA [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349], code=at0349, itemType=CLUSTER, level=2, text=Actual patient outcome details, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349]/items[at0042], code=at0042, itemType=ELEMENT, level=3, text=Actual patient outcome, description=The overall impact actually experienced by the patient., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • [A] Circumstances or events that have the capacity to cause error [*]
    • [B] An error that did not reach the patient [*]
    • [C] An error that reached the patient but did not cause harm [*]
    • [D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [*]
    • [E] Temporary harm to the patient and required intervention [*]
    • [F] Temporary harm to the patient and required initial or prolonged hospitalization [*]
    • [G] Permanent patient harm [*]
    • [H] Intervention required to sustain life [*]
    • [I] Patient death [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349]/items[at0350], code=at0350, itemType=ELEMENT, level=3, text=Comment, description=An additional comment on the Actual patient outcome comment., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0231], code=at0231, itemType=ELEMENT, level=2, text=Potential patient outcome, description=An assessment of potential impact on the patient if interventions had been unsuccesful. Uses the MERP index. other remediation had not occured., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • [A] Circumstances or events that have the capacity to cause error [*]
    • [B] An error that did not reach the patient [*]
    • [C] An error that reached the patient but did not cause harm [*]
    • [D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [*]
    • [E] Temporary harm to the patient and required intervention [*]
    • [F] Temporary harm to the patient and required initial or prolonged hospitalization [*]
    • [G] Permanent patient harm [*]
    • [H] Intervention required to sustain life [*]
    • [I] Patient death [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0043], code=at0043, itemType=ELEMENT, level=2, text=Patient outcome category, description=The caetgory of impact on the patient's life., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Clinical [*]
    • Personal [*]
    • Economic [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0232], code=at0232, itemType=ELEMENT, level=2, text=Additional comment, description=Any additional comment or narrative., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237], code=at0237, itemType=CLUSTER, level=2, text=Summary details, description=Details included only in Case Summary., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0238], code=at0238, itemType=ELEMENT, level=3, text=Admission diagnosis classification, description=Admission diagnosis using ICD classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0239], code=at0239, itemType=ELEMENT, level=3, text=Discharge diagnosis classification, description=Discharge diagnosis using ICD classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0249], code=at0249, itemType=ELEMENT, level=3, text=Link to main event, description=A link to the main case event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241], code=at0241, itemType=CLUSTER, level=3, text=Oncological case details, description=Details required for oncological cases., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0240], code=at0240, itemType=ELEMENT, level=4, text=TNM classification, description=Malignant disease classification using TNM., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0244], code=at0244, itemType=ELEMENT, level=4, text=Effectiveness of therapy, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Completely effective [The therapy has been fully effective.]
    • Partially effective [The therpay has been partially effective.]
    • Disease status unchanged [*]
    • Ineffective - disease progressing unchecked. [The therapy has been ineffective and the disease is progressing unchecked.]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0242], code=at0242, itemType=ELEMENT, level=4, text=Order of treatment, description=???????, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0243], code=at0243, itemType=ELEMENT, level=4, text=Reason for case closure, description=Reason for the case being closed., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Treatment complete [*]
    • Treatment aborted [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0268], code=at0268, itemType=ELEMENT, level=4, text=Reason treatment aborted, description=The reason why the treatment was aborted., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0351], code=at0351, itemType=ELEMENT, level=2, text=Medications involved, description=The medicine, vaccine or other therapetic good being ordered, administered to or used by the subject, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0352], code=at0352, itemType=ELEMENT, level=2, text=Medications administered, description=Medications administered is used to enter wrongly administered drug for Safety event type *at0254 Pacient dobil drugo zdravilo od predpisanega* Wrong drug administered to a patient, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], contacts=[], ism_transition=[], details=[], relationships=[], state=[], target=[], other_participations=[]}, topLevelItems={data=ResourceSimplifiedHierarchyItem [path=ROOT_/data[at0001], code=at0001, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=0..1, cardinalityText=optional, subCardinalityFormal=0..*, subCardinalityText=Minimum of 0 items, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=data, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0235], code=at0235, itemType=ELEMENT, level=2, text=Main event for case?, description=Is this the principal or main event recorded during the case?, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Allowed values: {true}, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Safety event type, description=The type of event reported., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    New constraint
    [*]

    Constraint binding:
    [SafetyEventType]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0003], code=at0003, itemType=ELEMENT, level=2, text=MEDRA classification, description=The category of event reported using MedDRA classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0004], code=at0004, itemType=ELEMENT, level=2, text=DateTime of event onset, description=The date and/or time that the adverse event took place., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0041], code=at0041, itemType=ELEMENT, level=2, text=Description of event, description=A narrative description of the medication safety event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233], code=at0233, itemType=CLUSTER, level=2, text=Cause of event, description=Details of the estimated cause of the event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233]/items[at0062], code=at0062, itemType=ELEMENT, level=3, text=Estimated cause of event, description=The reason suspected for this event occurring., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Verbal miscommunication [Verbal understanding]
    • Written miscomunication-Illegible handwritting [Written understanding]
    • Written miscomunication-Abbreviations [Illegible writing]
    • Written miscomunication-Non metric units of measurement [*]
    • Written miscomunication-Decimal point [*]
    • Misread or didnt read [*]
    • Misinterpretation of the order [*]
    • Sound-alike drug name [*]
    • Look-alike drug name [*]
    • Packaging-Inappropriate Packaging or Design [*]
    • Packing-Dosage form [*]
    • Packaging-Error due to similarity to another drug (colour, form, size) [*]
    • Packaging-Error due different strength [*]
    • Characteristics of the medicine [*]
    • Human factors-Lack of information/knowledge [*]
    • Work not accomplished [*]
    • Incomplete documentation [*]
    • Work overload, burn out syndrome [*]
    • Fatigue/Lack of sleep [*]
    • Confrontational or intimidating behaviour [*]
    • Control not carried out [*]
    • Inappropriate lighting [*]
    • Inappropriate temperature/humidity [*]
    • Frequent interuptions and distractions [*]
    • Lack of staff [*]
    • Other [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233]/items[at0234], code=at0234, itemType=ELEMENT, level=3, text=Comment, description=An additional comment on the estimated cause of the event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0020], code=at0020, itemType=ELEMENT, level=2, text=Related trigger, description=Triggers thought to be related to this safety event recorded using IHCI classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
    •  Coded Text
      • Transfusion of Blood or Use of Blood Products [**(en)]
      • Acute Dialysis [**(en)]
      • Positive Blood Culture [**(en)]
      • X-Ray or Doppler Studies for Emboli or Deep Vein Thrombosis [**(en)]
      • Decrease in Hemoglobin or Hematocrit of 25% or Greater [**(en)]
      • Patient Fall [**(en)]
      • Pressure Ulcers [**(en)]
      • Readmission within 30 Days [**(en)]
      • Restraint Use [**(en)]
      • Healthcare-Associated Infections [**(en)]
      • In-Hospital Stroke [**(en)]
      • Clostridium difficile Positive Stool [**(en)]
      • Partial Thromboplastin Time (PTT) Greater than 100 Seconds [**(en)]
      • International Normalized Ratio (INR) Greater than 6 [**(en)]
      • Glucose Less than 50 mg/dl [**(en)]
      • Rising BUN or Serum Creatinine Two Times (2x) over Baseline [**(en)]
      • Vitamin K Administration [**(en)]
      • Diphenhydramine (Benadryl) Administration [**(en)]
      • Romazicon (Flumazenil) Administration [**(en)]
      • Naloxone (Narcan) Administration [**(en)]
      • Anti-Emetic Administration [**(en)]
      • Over-Sedation/Hypotension [**(en)]
      • Abrupt Medication Stop [**(en)]
      • Intra- or Post-Operative Death [**(en)]
      • Mechanical Ventilation Greater than 24 Hours Post-Operatively [**(en)]
      • Intra-Operative Administration of Epinephrine, Norepinephrine, Naloxone, or Romazicon [**(en)]
      • Pneumonia Onset [**(en)]
      • Readmission to the Intensive Care Unit [**(en)]
      • Terbutaline Use [**(en)]
      • Platelet Count Less than 50,000 [**(en)]
      • Administration of Oxytocic Agents (such as oxytocin, methylergonovine, and 15-methyl-prostaglandin in the post-partum period) [**(en)]
      • Administration of General Anesthesia [**(en)]
      • Readmission to the ED within 48 Hours [**(en)]
      • Time in ED Greater than 6 Hours [**(en)]
      • Abnormal laboratory parameter [*]
      • Falsely abnormal laboratory parameter [*]
      • Unknown [**(en)]
      • No trigger [*]
    •  Text
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018], code=at0018, itemType=CLUSTER, level=2, text=Adverse effect, description=Details of one or more side effects., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345], code=at0345, itemType=CLUSTER, level=3, text=Reaction details, description=Details of reaction, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345]/items[at0021], code=at0021, itemType=ELEMENT, level=4, text=Reaction, description=Description of the side-effect reported or observed using MEDRA or ATC codes., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345]/items[at0346], code=at0346, itemType=ELEMENT, level=4, text=Comment, description=An additional comment on the Reaction details., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0108], code=at0108, itemType=ELEMENT, level=3, text=DateTime of reaction onset, description=The datetime at which the side effects began., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0222], code=at0222, itemType=ELEMENT, level=3, text=Severity, description=The severity of the reaction., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Low [*]
    • Medium [*]
    • High [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0022], code=at0022, itemType=ELEMENT, level=3, text=Liklihood of causation, description=An estimate of how likely the side-effects noted are due to the safety event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Low [*]
    • Medium [*]
    • High [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236], code=at0236, itemType=CLUSTER, level=3, text=Intervention details, description=Details of interventions., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347], code=at0347, itemType=CLUSTER, level=4, text=Intervention additional details, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347]/items[at0012], code=at0012, itemType=ELEMENT, level=5, text=Intervention, description=The clinical intervention undertaken to resolve or ameliorate the adverse effect, uses PCNE terminology., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Prescriber informed [**(en)]
    • Nurse informed/instructed [**(en)]
    • Dispensing rejected [**(en)]
    • Drug recalled from the ward [**(en)]
    • Dietary regime changed [**(en)]
    • Food supplement discontinued [**(en)]
    • Food supplement initiated [**(en)]
    • Reconstitution solvent changed [**(en)]
    • Diluent changed [**(en)]
    • Medical device (or change) suggested [*]
    • Drug changed [**(en)]
    • Dose increased [**(en)]
    • Dose decreased [**(en)]
    • Dosage form changed [**(en)]
    • Administration interval changed [**(en)]
    • Drug discontinued [**(en)]
    • Drug initiated [**(en)]
    • Drug administration rate changed [**(en)]
    • Route of administration changed [**(en)]
    • Resuscitation required [**(en)]
    • Heamodialysis required [**(en)]
    • Transplantation required [**(en)]
    • Transfusion required [**(en)]
    • Operating procedure required [**(en)]
    • Additional laboratory test(s) required [**(en)]
    • Physiotherapy required [**(en)]
    • Psychotherapy required [**(en)]
    • Error corrected [*]
    • Monitoring required [*]
    • Patient informed [*]
    • Other [**(en)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347]/items[at0348], code=at0348, itemType=ELEMENT, level=5, text=Comment, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0014], code=at0014, itemType=ELEMENT, level=4, text=Intervention result, description=The result(s) of any interventions undertaken, recorded using MEDRA classification subset., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • *Intervencija preprečila, da bi zaplet dosegel pacienta(en) [*(en)]
    • *Intervencija popolnoma odpravila posledice, ki jih je zaplet povzročil pacientu(en) [*(en)]
    • *Intervencija delno odpravila posledice, ki jih je zaplet povzročil pacientu(en) [*(en)]
    • *Intervencija ni odpravila posledic, ki jih je zaplet povzročil pacientu(en) [*(en)]
    • *Intervencija ni bila možna(en) [*(en)]
    • *Rezultat intervencije ni poznan(en) [*(en)]
    • *Zmanjšanje stroškov zdravljenja(en) [*(en)]
    • *Skrajšan čas hospitalizacije(en) [*(en)]
    • *Pacient je bil odpuščen(en) [*(en)]
    • *Izboljšana kvaliteta življenja(en) [*(en)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0353], code=at0353, itemType=ELEMENT, level=2, text=Side effect recurrence, description=This information is aplicable when at least one Intervention is Dose decreased or Drug discontinued, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Yes [*]
    • No [*]
    • NA [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349], code=at0349, itemType=CLUSTER, level=2, text=Actual patient outcome details, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349]/items[at0042], code=at0042, itemType=ELEMENT, level=3, text=Actual patient outcome, description=The overall impact actually experienced by the patient., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • [A] Circumstances or events that have the capacity to cause error [*]
    • [B] An error that did not reach the patient [*]
    • [C] An error that reached the patient but did not cause harm [*]
    • [D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [*]
    • [E] Temporary harm to the patient and required intervention [*]
    • [F] Temporary harm to the patient and required initial or prolonged hospitalization [*]
    • [G] Permanent patient harm [*]
    • [H] Intervention required to sustain life [*]
    • [I] Patient death [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349]/items[at0350], code=at0350, itemType=ELEMENT, level=3, text=Comment, description=An additional comment on the Actual patient outcome comment., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0231], code=at0231, itemType=ELEMENT, level=2, text=Potential patient outcome, description=An assessment of potential impact on the patient if interventions had been unsuccesful. Uses the MERP index. other remediation had not occured., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • [A] Circumstances or events that have the capacity to cause error [*]
    • [B] An error that did not reach the patient [*]
    • [C] An error that reached the patient but did not cause harm [*]
    • [D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [*]
    • [E] Temporary harm to the patient and required intervention [*]
    • [F] Temporary harm to the patient and required initial or prolonged hospitalization [*]
    • [G] Permanent patient harm [*]
    • [H] Intervention required to sustain life [*]
    • [I] Patient death [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0043], code=at0043, itemType=ELEMENT, level=2, text=Patient outcome category, description=The caetgory of impact on the patient's life., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Clinical [*]
    • Personal [*]
    • Economic [*]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0232], code=at0232, itemType=ELEMENT, level=2, text=Additional comment, description=Any additional comment or narrative., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237], code=at0237, itemType=CLUSTER, level=2, text=Summary details, description=Details included only in Case Summary., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0238], code=at0238, itemType=ELEMENT, level=3, text=Admission diagnosis classification, description=Admission diagnosis using ICD classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0239], code=at0239, itemType=ELEMENT, level=3, text=Discharge diagnosis classification, description=Discharge diagnosis using ICD classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0249], code=at0249, itemType=ELEMENT, level=3, text=Link to main event, description=A link to the main case event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241], code=at0241, itemType=CLUSTER, level=3, text=Oncological case details, description=Details required for oncological cases., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0240], code=at0240, itemType=ELEMENT, level=4, text=TNM classification, description=Malignant disease classification using TNM., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
    *New constraint(sl)
    [**(sl)]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0244], code=at0244, itemType=ELEMENT, level=4, text=Effectiveness of therapy, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Completely effective [The therapy has been fully effective.]
    • Partially effective [The therpay has been partially effective.]
    • Disease status unchanged [*]
    • Ineffective - disease progressing unchecked. [The therapy has been ineffective and the disease is progressing unchecked.]
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0242], code=at0242, itemType=ELEMENT, level=4, text=Order of treatment, description=???????, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0243], code=at0243, itemType=ELEMENT, level=4, text=Reason for case closure, description=Reason for the case being closed., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
    • Treatment complete [*]
    • Treatment aborted [*]
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