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final Transaction NFDI4Health Resource 2.16.840.1.113883.3.1937.777.64.4.12

Data Set Module Chronic Diseases (V3.3) 2.16.840.1.113883.3.1937.777.64.1.4

Name Id
final NFDI4Health Resource (v3.3) 2.16.840.1.113883.3.1937.777.64.4.12
Effective date Expiration date
2024‑01‑06
Description
Name Details [‑]
folder deprecated ChronicDiseasesEpidemiology Conditional
nfdhtfcov19-dataelement-117
Id nfdhtfcov19-dataelement-117 (2023‑11‑30) v3.3
Cardinality Conditional

Card/Conf Condition
1 … * Mandatory 1..*, if Resource.chronicDiseases == "Yes" AND Resource.classification.type == ("Study protocol" OR "Informed consent form" OR "Patient information sheet" OR "Manual of operations (SOPs)" OR "Statistical analysis plan" OR "Data management plan" OR "Case report form" OR "Interview scheme and themes" OR "Observation guide" OR "Discussion guide" OR "Participant tasks" OR "Other study document" OR "Other")
0 … 0 Not permitted 0..0, if Resource.chronicDiseases != "Yes" OR Resource.classification.type != ("Study protocol" OR "Informed consent form" OR "Patient information sheet" OR "Manual of operations (SOPs)" OR "Statistical analysis plan" OR "Data management plan" OR "Case report form" OR "Interview scheme and themes" OR "Observation guide" OR "Discussion guide" OR "Participant tasks" OR "Other study document" OR "Other")

Description

Chronic disease data collected in the [RESOURCE]

Properties

ChronicDiseasesEpidemiology

ChronicDiseasesEpidemiology

Relationship
Rationale

Description: Group of items providing information on chronic disease data collection.

Source

NFDI4Health UC 5.2 requirements

Comment

Cardinality: 1..*, if Resource.chronicDiseases == 'Yes' AND Resource.classification.type == ('Study protocol' OR 'Informed consent form' OR 'Patient information sheet' OR 'Manual of operations (SOPs)' OR 'Statistical analysis plan' OR 'Data management plan' OR 'Case report form' OR 'Interview scheme and themes' OR 'Observation guide' OR 'Discussion guide' OR 'Participant tasks' OR 'Other study document' OR 'Other'); otherwise 0.. 0

Comment

Cardinality: 1..*, if Resource.chronicDiseases == 'True' AND Resource.classification.type == ('C93381' OR 'C16468' OR 'C15518' OR 'C115779' OR 'C115761' OR 'C115756' OR 'C40988' OR '016' OR '017' OR '018' OR '019' OR '021' OR 'C17649'); otherwise 0.. 0

target Used by one transaction, 0 templates, inherited 0 times
 
deprecated commonChronicDiseaseName 1 … 1 Mandatory
nfdhtfcov19-dataelement-102
Id nfdhtfcov19-dataelement-102 (2023‑11‑30) v3.3
Cardinality 1 … 1 Mandatory
Description

On which of the following common chronic diseases were data collected?

Properties

ChronicDiseasesEpidemiology.commonChronicDiseaseName

ChronicDiseasesEpidemiology.commonChronicDiseaseName

Relationship
Rationale

Description: Common chronic diseases on which data were collected in the study.

Source

NFDI4Health UC 5.2 requirements

ICD-10 [https://icd.who.int/browse10/2019/en]

Zentrum für Krebsregisterdaten [ https://www.krebsdaten.de/]

Statistisches Bundesamt [ https://www.destatis.de/]

Comment

Additional information: The values originate from the following sources: 1) 10 types of cancer with the highest incidence in Germany, by gender, based on 2017/2018 German cancer registry data (RKI, Zentrum für Krebsregisterdaten, https://www.krebsdaten.de/); 2) 10 cardiovascular diseases with highest mortality in Germany in 2020 (www.destatis.de).

All values follow the classifiction system ICD-10 (WHO's International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10), https://icd.who.int/en).

Comment

Cardinality: 1..1

Value Domain Code
Choice list
Concept List
Concept Description Assigned references
Malignant neoplasms (C00-C97)
code "363346000" (Malignant neoplasms) from code system "SNOMED Clinical Terms"
Type 2 Diabetes mellitus   (E11-E14)
code "44054006" (Diabetes mellitus type 2) from code system "SNOMED Clinical Terms"
Hyperlipidaemia (E78)
code "55822004" (Hyperlipidemia) from code system "SNOMED Clinical Terms"
Hypertensive diseases (I10-I15)
code "38341003" (Hypertensive disorder) from code system "SNOMED Clinical Terms"
Ischaemic heart diseases (I20-I25)
code "414545008" (Ischemic heart disease) from code system "SNOMED Clinical Terms"
Heart valve diseases  (I34-I39)
code "368009" (Heart valve disorder) from code system "SNOMED Clinical Terms"
Cardiac arrhythmia (I47-I49)
code "698247007" (Cardiac arrhythmia) from code system "SNOMED Clinical Terms"
Heart failure  (I50)
code "84114007" (Heart failure) from code system "SNOMED Clinical Terms"
Cerebrovascular diseases (I60-I69)
code "62914000" (Cerebrovascular disease) from code system "SNOMED Clinical Terms"
Diseases of the circulatory system falling into multiple categories
code "49601007" (Disorder of cardiovascular system) from code system "SNOMED Clinical Terms"
Data not collected for any of the above-listed diseases
code "201" (Data not collected for any of the above-listed diseases) from code system "NFDI4Health_CS_MDS_Remaining_Concepts3.3"

Value Set NFDI4Health_VS_MDS_CD_CommonChronicDiseaseName_SCT_Local (version 2024‑03‑01 13:01:35)
target Used by one transaction, 0 templates, inherited once
 
deprecated dataCollected 1 … 1 Mandatory
nfdhtfcov19-dataelement-118
Id nfdhtfcov19-dataelement-118 (2023‑11‑30) v3.3
Cardinality 1 … 1 Mandatory
Description

Type of data collected

Properties

ChronicDiseasesEpidemiology.dataCollected

ChronicDiseasesEpidemiology.dataCollected

Relationship
Rationale

Description: Specification of the type of data collected.

Source

NFDI4Health UC 5.2 requirements

Comment

Cardinality: 1..1

Value Domain Code
Choice list
Concept List
Concept Description Assigned references
Prevalent

Persons in a population who have a particular disease or attribute at a specified point in time or over a specified period of time [CDC.gov (https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section2.html)].

code "C17010" (Prevalence) from code system "FDA RouteOfAdministration"
Incident

Occurrence of new cases of disease or injury in a population over a specified period of time [CDC.gov (https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section2.html)].

code "C16726" (Incidence) from code system "FDA RouteOfAdministration"

Value Set required NFDI4Health_VS_MDS_CD_DataCollected_NCI (version 2024‑01‑22 12:52:07)
target Used by one transaction, 0 templates, inherited 0 times
 
deprecated informationSources 1 … * Mandatory
nfdhtfcov19-dataelement-119
Id nfdhtfcov19-dataelement-119 (2023‑11‑30) v3.3
Cardinality 1 … * Mandatory
Description

From which source(s) are data generated/extracted?

Properties

ChronicDiseasesEpidemiology.informationSources

ChronicDiseasesEpidemiology.informationSources

Relationship
Rationale

Description: Specification of the source(s) from which information is generated/extracted.

Source

NFDI4Health UC 5.2 requirements

Comment

Additional information: Treat prevalent and incident diseases separately (selected values should be specific for prevalent diseases and then separately incident diseases).

Comment

Cardinality: 1..*

Value Domain Code
Choice list
Concept List
Concept Description Assigned references
Self-report (questionnaires or interviews), cases verified

A method of data collection which involves asking a participant, for example, through questionnaires or interviews. The collected information is then verified by asking the treating physician, through administrative databases (e.g., health insurance data), or clinical examinations [NFDI4Health].

code "116" (Self-report (questionnaires or interviews), cases verified) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Self-report (questionnaires or interviews), cases not verified

A method of data collection which involves asking a participant, for example, through questionnaires or interviews. The collected information is not verified by any external information or clinical examinations [NFDI4Health].

code "117" (Self-report (questionnaires or interviews), cases not verified) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Administrative databases

Information about administrative data [Maelstrom (doi: 10.1371/journal.pone.0200926)].

code "C15426" (Database) from code system "FDA RouteOfAdministration"
Biosamples

A sample of material, such as urine, blood, tissue, cells, DNA, RNA, or protein, from the study subject [NCI Dictionary of Cancer Terms (https://www.cancer.gov/publications/dictionaries/cancer-terms)].

code "C43412" (Biosample) from code system "FDA RouteOfAdministration"
Physical measures (e.g., clinical examination)

Information about physical functioning. Information in this domain is generally measured [Maelstrom (doi: 10.1371/journal.pone.0200926)].

code "C20989" (Physical Examination) from code system "FDA RouteOfAdministration"
Other

Sources of data other than self-report, administrative databases, biosamples and physical measures [NFDI4Health].

code "C17649" (Other) from code system "FDA RouteOfAdministration"

Value Set required NFDI4Health_VS_MDS_CD_Information_Sources_NCI_Local (version 2024‑01‑22 13:10:39)
target Used by one transaction, 0 templates, inherited once
 
deprecated outcomesVerificationMethods 0 … *
nfdhtfcov19-dataelement-122
Id nfdhtfcov19-dataelement-122 (2023‑11‑30 20:55:16) v3.3
Cardinality 0 … *
Description

How were outcomes generally verified?

Properties

ChronicDiseasesEpidemiology.outcomesVerificationMethods

ChronicDiseasesEpidemiology.outcomesVerificationMethods

Rationale

Description: Methods of verification differ by study. All the details per outcome are not needed here but rather an explanation of how outcomes were verified in general.

Source

NFDI4Health UC 5.2 requirements

Comment

Cardinality: 0..*

Value Domain String
target Used by one transaction, 0 templates, inherited once