TEMPLATE Fragebogen 1FT21 (Fragebogen 1FT21)

TEMPLATE ID	Fragebogen 1FT21
Concept	Fragebogen 1FT21
Description	Zur Repräsentation der FastTrack Studie: Zell. und hum. Immunität nach COVID-19 in Patienten nach Lebertransplantation für das Covid-19 Forschungsnetzwerk Niedersachsen (COFONI).
Use	Zur Repräsentation der FastTrack Studie: Zell. und hum. Immunität nach COVID-19 in Patienten nach Lebertransplantation
Misuse	Nicht anwendbar für andere klinische Studien außerhalb COFONI.
Purpose	Zur Repräsentation der FastTrack Studie: Zell. und hum. Immunität nach COVID-19 in Patienten nach Lebertransplantation für das Covid-19 Forschungsnetzwerk Niedersachsen (COFONI).
References
Authors	date: 2023-04-06; name: Kristina Scheuermann; organisation: Peter L. Reichertz Institut für Medizinische Informatik der TU Braunschweig und der Medizinischen Hochschule Hannover; email: scheuermann.kristina@mh-hannover.de
Other Details Language	date: 2023-04-06; name: Kristina Scheuermann; organisation: Peter L. Reichertz Institut für Medizinische Informatik der TU Braunschweig und der Medizinischen Hochschule Hannover; email: scheuermann.kristina@mh-hannover.de
Other Details (Language Independent)	Sem Ver: 82.0.0 Build Uid: 676aed81-6a80-4ecf-a770-df783ec7f32f MD5-CAM-1.0.1: ae2f9b259c4ecbcce2bfc042ecf977a6 PARENT:MD5-CAM-1.0.1: A60D0B7F52F1F9C3C9B3518DB83ACDAE Original Language: ISO_639-1::de
Keywords	Cofoni, Covid, Covid19, Infektion, Studie, Fast Track, Lebertransplantation, Immunsuppressiva
Language used	en
Citeable Identifier	1246.169.2999
Root archetype id	openEHR-EHR-COMPOSITION.report.v1
Fragebogen_1FT21	Fragebogen_1FT21: Document to communicate information to others, commonly in response to a request from another party.
Other Context
Study participation	Study participation: Details about participation in a clinical trial, observational study, registry study, diagnostic study, therapeutic study, or other medical research project in the role of a study patient or subject.
Study name	Study name: Designation of the study or clinical trial in which the patient is participating. The title or study code of the study, e.g. AIO-HEP-0116. Terminology: local_terms Protective immunity against SARS-CoV-2 in immunosuppressed COVID-19
Demographische Daten	Demographische Daten: A generic section header which should be renamed in a template to suit a specific clinical context.
Gender	Gender: Details about the gender of an individual.
Data
Sex assigned at birth	Sex assigned at birth: The sex of an individual determined by anatomical characteristics observed and registered at birth. For example: 'Male', 'Female', 'Intersex'. Coding with a terminology is recommended, where possible. Use the element 'Comment' or the SLOT 'Details' if needed to register more specific details of the individuals gender. Terminology: SNOMED Clinical Terms Masculine gender (finding) Feminine gender (finding)
Age assertion	Age assertion: A statement about the age of an individual at a point in time.
Data
Point in time event	Point in time event: Default, unspecified point in time event which may be explicitly defined in a template or at run-time.
Data
Chronological age	Chronological age: The age of an individual at the event time, calculated from date of birth. In most use cases the DV_DURATION data type is used to record the Chronological age. The DV_INTERVAL_DURATION is used for recording a structured age interval in cases where there's uncertainty about the individual's exact age. The DV_QUANTITY data type is used for recording a decimal age in years or mean Julian years (365.25 days). The DV_TEXT data type is used for recording a textual representation of the individual's age, or age category often found in questionnaires. For example: 'P3M2W', '0,2884615384615385 a_j', '3 months 2 weeks' or '31-40 years' or 'Teenager'. 0..200; 0..200; 0..200 Units: yr (UCUM: a) a_j
Anamnese	Anamnese: A generic section header which should be renamed in a template to suit a specific clinical context.
Lebertransplantation	Lebertransplantation: A clinical activity carried out for screening, investigative, diagnostic, curative, therapeutic, evaluative or palliative purposes.
Description
Procedure name	Procedure name: Identification of the procedure by name. Coding of the specific procedure with a terminology is preferred, where possible. Terminology: SNOMED Clinical Terms Transplantation of liver
Indication	Indication: The clinical or process-related reason for the procedure. Coding of the indication with a terminology is preferred, where possible. This data element allows multiple occurrences. For example: 'Failed bowel preparation' or 'Bowel cancer screening'.
Problem/Diagnosis	Problem/Diagnosis: Details about a single identified health condition, injury, disability or any other issue which impacts on the physical, mental and/or social well-being of an individual. Clear delineation between the scope of a problem versus a diagnosis is not easy to achieve in practice. For the purposes of clinical documentation with this archetype, problem and diagnosis are regarded as a continuum, with increasing levels of detail and supportive evidence usually providing weight towards the label of 'diagnosis'.
Data
Problem/Diagnosis name	Problem/Diagnosis name: Identification of the problem or diagnosis, by name. Coding of the name of the problem or diagnosis with a terminology is preferred, where possible. Terminology: SNOMED Clinical Terms Chronic kidney disease (disorder)
Covid-19 Erkrankung	Covid-19 Erkrankung: Details about a single identified health condition, injury, disability or any other issue which impacts on the physical, mental and/or social well-being of an individual. Clear delineation between the scope of a problem versus a diagnosis is not easy to achieve in practice. For the purposes of clinical documentation with this archetype, problem and diagnosis are regarded as a continuum, with increasing levels of detail and supportive evidence usually providing weight towards the label of 'diagnosis'.
Data
Problem/Diagnosis name	Problem/Diagnosis name: Identification of the problem or diagnosis, by name. Coding of the name of the problem or diagnosis with a terminology is preferred, where possible. Terminology: SNOMED Clinical Terms Disease caused by severe acute respiratory syndrome coronavirus 2
Severity	Severity: An assessment of the overall severity of the problem or diagnosis. If severity is included in the Problem/diagnosis name via precoordinated codes, this data element becomes redundant. Note: more specific grading of severity can be recorded using the Specific details SLOT. Terminology: SNOMED Clinical Terms Mild (qualifier value) Moderate (severity modifier) (qualifier value) Severe (severity modifier) (qualifier value) Life threatening severity (qualifier value)
Symptom/Sign	Symptom/Sign: Reported observation of a physical or mental disturbance in an individual.
Symptom/Sign name	Symptom/Sign name: The name of the reported symptom or sign. Symptom name should be coded with a terminology, where possible. Terminology: SNOMED Clinical Terms Cough (finding) Fatigue (finding) Fever (finding) Pain (finding) Headache (finding) Pain in throat (finding) Sweating (finding) Sniffles (finding) Dyspnea (finding) Other (qualifier value)
Weitere Symptome	Weitere Symptome: Simple body site where the symptom or sign was reported. Occurrences of this data element are set to 0..* to allow multiple body sites to be separated out in a template if desired. This allows for representation of clinical scenarios where a symptom or sign needs to be recorded in multiple locations or identifying both the originating and distal site in pain radiation, but where all of the other attributes such as impact and duration are identical. If the requirements for recording the body site are determined at run-time by the application or require more complex modelling such as relative locations then use the CLUSTER.anatomical_location or CLUSTER.relative_location within the Detailed anatomical location' SLOT in this archetype. If the anatomical location is included in the Symptom name via precoordinated codes, this data element becomes redundant. If the anatomical location is recorded using the 'Structured body site' SLOT, then use of this data element is not allowed - record only the simple 'Body site' OR 'Structured body site', but not both.
Schweregrad Bewertungsskala	Schweregrad Bewertungsskala: The result of a laboratory test for a single analyte value.
WHO CPS-Skala	WHO CPS-Skala: The value of the analyte result. For example '7.3 mmol/l', 'Raised'. The 'Any' data type will need to be constrained to an appropriate data type in a specialisation, a template or at run-time to reflect the actual analyte result. The Quantity data type has reference model attributes that include flags for normal/abnormal, reference ranges and approximations - see https://specifications.openehr.org/releases/RM/latest/data_types.html#_dv_quantity_class for more details. Optional[{fhir_mapping=Observation.value[x], hl7v2_mapping=OBX.2, OBX.5, OBX.6, OBX.7, OBX.8}] Terminology: local_terms 0 - Uninfected; no viral RNA detected 1 - Ambulatory mild disease; Asymptomatic; viral RNA detected 2 - Ambulatory mild disease; Symptomatic; independent 3 - Ambulatory mild disease; Symptomatic; assistance needed 4 - Hospitalised: moderate disease; Hospitalised; no oxygen therapy 5 - Hospitalised: moderate disease; Hospitalised; oxygen by mask or nasal prongs 6 - Hospialised: severe disease; Hospitalised; oxygen by NIV or high flow 7 - Hospialised: severe disease; Intubation and mechanical ventilation, pO2/FiO2>=150 or SpO2/FiO2>=200 8 - Hospialised: severe disease; Mechanical ventilation pO2/FiO2 < 150 (spO2/FiO2 < 200) or vasopressors 9 - Hospialised: severe disease; Mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO 10 - Dead
Protocol
Timing - non-daily	Timing - non-daily: Structured information about the intended timing pattern for a therapeutic or diagnostic activity occurring over days, weeks, months or years.
Specific event	Specific event: The activity should take place in relation to a specific named event.
Zeitspanne nach der Transplantation in Monaten	Zeitspanne nach der Transplantation in Monaten: The period of time before or after the named event when the activity should take place. Negative durations can be used to signify that the activity should be taken before a known event. For example: '3 days after onset of menstruation = menstrual onset + 3 days', '2 weeks prior to admission= admission -2 weeks'. Units: Month
Laboratory analyte result	Laboratory analyte result: The result of a laboratory test for a single analyte value.
Analyte result	Analyte result: The value of the analyte result. For example '7.3 mmol/l', 'Raised'. The 'Any' data type will need to be constrained to an appropriate data type in a specialisation, a template or at run-time to reflect the actual analyte result. The Quantity data type has reference model attributes that include flags for normal/abnormal, reference ranges and approximations - see https://specifications.openehr.org/releases/RM/latest/data_types.html#_dv_quantity_class for more details. Optional[{fhir_mapping=Observation.value[x], hl7v2_mapping=OBX.2, OBX.5, OBX.6, OBX.7, OBX.8}] Terminology: SNOMED Clinical Terms Detected (qualifier value) Not detected (qualifier value)
Covid-19 Impfung	Covid-19 Impfung: Any activity related to the planning, scheduling, prescription management, dispensing, administration, cessation and other use of a medication, vaccine, nutritional product or other therapeutic item. This is not limited to activities performed based on medication orders from clinicians, but could also include for example taking over the counter medication.
Description
Medication item	Medication item: Name of the medication, vaccine or other therapeutic/prescribable item which was the focus of the activity. For example: 'Atenolol 100mg' or 'Tenormin tablets 100mg'. It is strongly recommended that the 'Medication item' is coded with a terminology capable of triggering decision support, where possible. The extent of coding may vary from the simple name of the medication item through to structured details about the actual medication pack used. Free text entry should only be used if there is no appropriate terminology available. Terminology: SNOMED Clinical Terms Administration of vaccine product against severe acute respiratory syndrome coronavirus 2
Immunosuppressive Therapie	Immunosuppressive Therapie: A generic section header which should be renamed in a template to suit a specific clinical context.
Medication management	Medication management: Any activity related to the planning, scheduling, prescription management, dispensing, administration, cessation and other use of a medication, vaccine, nutritional product or other therapeutic item. This is not limited to activities performed based on medication orders from clinicians, but could also include for example taking over the counter medication.
Description
Medication item	Medication item: Name of the medication, vaccine or other therapeutic/prescribable item which was the focus of the activity. For example: 'Atenolol 100mg' or 'Tenormin tablets 100mg'. It is strongly recommended that the 'Medication item' is coded with a terminology capable of triggering decision support, where possible. The extent of coding may vary from the simple name of the medication item through to structured details about the actual medication pack used. Free text entry should only be used if there is no appropriate terminology available. Terminology: SNOMED Clinical Terms Product containing prednisolone Product containing tacrolimus Product containing ciclosporin Product containing mycophenolic acid Product containing everolimus Product containing azathioprine Product containing sirolimus Product containing steroid
Dosage	Dosage: The combination of a medication amount and administration timing for a single day, in the context of a medication order or medication management. For example: '2 tablets at 6pm' or '20 mg three times per day'. Please note: this cluster allows multiple occurrences to enable representation of a complete set of dose patterns for a single dose direction.
Dose	Dose: The amount of medication administered at one time. For example: 1 mg, 1.5 ml, 0.125 g; or 1-2 ml, 12.5-20.5 mg.
Eingenommen?	Eingenommen?: The pathway step has been checked by a separate individual. Details of the individual performing the double-check can be carried in the Reference Model element "Participation".
Follow-up	Follow-up: A generic section header which should be renamed in a template to suit a specific clinical context.
Procedure	Procedure: A clinical activity carried out for screening, investigative, diagnostic, curative, therapeutic, evaluative or palliative purposes.
Description
Name der Leistung	Name der Leistung: Identification of the procedure by name. Coding of the specific procedure with a terminology is preferred, where possible. Terminology: local_terms Screening prior to the COVID-19 disease. Screening shortly after the COVID-19 disease.
Protocol
Laboratory analyte result	Laboratory analyte result: The result of a laboratory test for a single analyte value.
Laboratory analyte result	Laboratory analyte result: The result of a laboratory test for a single analyte value.
Analyte name	Analyte name: The name of the analyte result. The value for this element is normally supplied in a specialisation, in a template or at run-time to reflect the actual analyte. For example: 'Serum sodium', 'Haemoglobin'. Coding with an external terminology is strongly recommended, such as LOINC, NPU, SNOMED CT, or local lab terminologies. Optional[{fhir_mapping=Observation.code, hl7v2_mapping=OBX.3}] Terminology: SNOMED Clinical Terms Immunoglobulin G Immunoglobulin A Immunoglobulin M Alanine aminotransferase Aspartate aminotransferase Alkaline phosphatase Gamma-glutamyltransferase Bilirubin C reactive protein Influenza A virus antibody Cytomegalovirus antibody Antigen of Human orthopneumovirus Antigen of Human coronavirus 229E Antigen of Human coronavirus OC43 Antigen of severe acute respiratory syndrome coronavirus 2 Liver transient elastography fibrosis score INR (International normalized ratio) Butyrylcholinesterase Population of all leukocytes in portion of fluid Human leukocyte antigen
Analyte result	Analyte result: The value of the analyte result. For example '7.3 mmol/l', 'Raised'. The 'Any' data type will need to be constrained to an appropriate data type in a specialisation, a template or at run-time to reflect the actual analyte result. The Quantity data type has reference model attributes that include flags for normal/abnormal, reference ranges and approximations - see https://specifications.openehr.org/releases/RM/latest/data_types.html#_dv_quantity_class for more details. Optional[{fhir_mapping=Observation.value[x], hl7v2_mapping=OBX.2, OBX.5, OBX.6, OBX.7, OBX.8}] Boolean Quantity Text
Spezifikation	Spezifikation: Additional advice on the applicability of the reference range to this result or may carry text or coded textual guidance as to whether the result is within the normal range. For example, 'within normal limits for age and sex'. Terminology: local_terms N M S Viral 1 Viral 2 Select 42-SARS-CoV-2 Spike S1 45-SARS-CoV-2 Spike S2 48-SARS-CoV-2 RBD 51-SARS-CoV-2 N
Test method	Test method: Description about the method used to perform the test on this analyte only. If the test method applies to an entire panel, the test method can be captured using the 'Test method' data element within the OBSERVATION.laboratory_test_result Spots/2.5x10^5PBMCs Spots/10.000 CD3+
Comment	Comment: Additional narrative about the analyte result, not captured in other fields. Optional[{fhir_mapping=Observation.note, hl7v2_mapping=NTE.3}]
Cut-Off-Value	Cut-Off-Value: Additional advice on the applicability of the reference range to this result or may carry text or coded textual guidance as to whether the result is within the normal range. For example, 'within normal limits for age and sex'. 34,9 317,2 214,3 152,1 168,6 962,6 1799,9 817,4 664,6 6304,5 2461,8 5861,8
Other contributors	Mareike Joseph