Diastolic Blood Pressure

1
Property or Attribute C35552
The distinguishing qualities or prominent aspect
of a person, object, action, process, or
substance.
Personal Attribute C19332
The distinguishing qualities or prominent aspects
of an individual person.
The pressure of the circulating blood against the
walls of the blood vessels.
Blood Pressure C54706
The blood pressure after the contraction of the
heart while the chambers of the heart refill with
blood.
Diastolic Blood Pressure C25299 CDISC VSTESTCD
DIABP
NCIs Thesaurus relates concept in hierarical
structure by using super- and sub-concepts.
2
Any specific activity undertaken during the
course of a clinical study or research protocol.
Clinical or Research Activity C16203
Activity or measure that produces an effect or
that is intended to alter the course of a disease
in patient or population. This is a general term
encompassing medical, social, behavioral,
environmental and other acts that can have
preventive and/or therapeutic impact. .
Intervention or Procedure C25218
A medical procedure that involves testing a
sample of blood, urine, or other substance from
the body. Tests can help determine a diagnosis,
plan treatment, check to see if treatment is
working, or monitor the disease over time.
Laboratory Procedure C25294
Chemistry Test C49237
Protein or Enzyme Type Measurement C64430
CDISC Definition A measurement of the
Choriogonadotropin Beta in a biological specimen.
NCI Defintion A determination of the presence
of Choriogonadotropin Beta protein.
Choriogonadotropin Beta Measurement C64851
CDISC LBTESTCD HCGSynonym Pregnancy Test
NCIs Thesaurus relates concept in hierarical
structure by using super- and sub-concepts.
3
Specification of human conditions relevant to
cancer. This includes observations, test results,
history, and other concepts relevant to
characterization of human cancer-related
conditions. Non-neoplastic conditions of interest
are also included.
Disease, Disorder or FindingC7057
Objective evidence of disease perceptible to the
examining physician (sign) and subjective
evidence of disease perceived by the patient
(symptom)..
Finding C3367
Finding by Site or System C36278
Cardiovascular System Finding C35552
Patient complaints (symptoms), physical/laboratory
findings(signs) related to the cardiovascular
system.
Blood Pressure Finding C54707
A test result that reports the diastolic and
systolic pressure of the blood.
Hypertension C3117
Pathological increase in blood pressure a
repeatedly elevated blood pressure exceeding 140
over 90 mmHg
Postpartum Hypertension C35802
NCIs Thesaurus relates concept in hierarical
structure by using super- and sub-concepts.
4
CDISC SDTM and related initativies
All terms and conceptsare incorporated from NCI
Thesaurus thorugh NCI EVS
SDTM variables specifiedas packages of
ControlledTerminologies Published as an Excel
matrixeson CDISC website
NCI Thesaurus
In OWL format
CDISCClinical Data Interchange Standards
Consortium
UMLS
RCRIM Regulated Clinical Research and
Information Management,technical committee
Relationship HL7/CDISC
BRIDGBiomedical Research Integrated Domain Group
Model
HL7 Health Level Seven
5
CDISCs Controlled Terminoligy for VSTEST
Codesas part of package 1
Published as an Excel matrixeson CDISC website
6
Concept structures in NCIs Thesaurus for
Concepts that have been in aligned to proposed
CDISCs VSTEST Codes
Action
Personal Attribute
Property or Attribute
Conceptual Entities
Finding by Site or System
Anatomic StructureSystem or Substance
Observation
Characteristic
Blood Pressure
Body Mass IndexBMI
TemperatureTEMP
Cardiovascular System Finding
Body Frame SizeFRMSIZE
Body Surface AreaBSA
Microanatomic Structure
Vital Signs Test Name
WeightWEIGHT
Diastolic Pressure DIABP
Systolic Pressure SYSBP
HeightHEIGHT
Tissue
Heart RateHR
Pulse RatePULSE
Respiratory RateRESP
Blood Pressure Finding
Connective and Soft Tissue
Mean Arterial PressureMAP
Soft Tissue
Adipose TissueBODYFAT
NCIs Thesaurus relates concept in hierarical
structure by using super- and sub-concepts.
7
Concept structures in NCIs Thesaurus for
Concepts that have been in aligned to proposed
CDISCs VSTEST Codes
Action
Personal Attribute
Property or Attribute
Conceptual Entities
Finding by Site or System
Anatomic StructureSystem or Substance
Observation
Characteristic
Blood Pressure
Body Mass IndexBMI
TemperatureTEMP
Cardiovascular System Finding
Body Frame SizeFRMSIZE
Body Surface AreaBSA
Microanatomic Structure
Vital Signs Test Name
WeightWEIGHT
Diastolic Pressure DIABP
Systolic Pressure SYSBP
HeightHEIGHT
Tissue
Heart RateHR
Pulse RatePULSE
Respiratory RateRESP
Blood Pressure Finding
Connective and Soft Tissue
Mean Arterial PressureMAP
Soft Tissue
The blood pressure after the contraction of the
heart while the chambers of the heart refill with
blood.
Adipose TissueBODYFAT
NCIs Thesaurus relates concept in hierarical
structure by using super- and sub-concepts.
8
Concept structures in NCIs Thesaurus for
Concepts that have been in aligned to proposed
CDISCs VSTEST Codes
Action
Personal Attribute
Property or Attribute
Conceptual Entities
Finding by Site or System
Anatomic StructureSystem or Substance
Observation
Characteristic
Blood Pressure
Body Mass IndexBMI
TemperatureTEMP
Cardiovascular System Finding
Body Frame SizeFRMSIZE
Body Surface AreaBSA
Microanatomic Structure
(Pulse)
Vital Signs Test Name
WeightWEIGHT
Diastolic Pressure DIABP
Systolic Pressure SYSBP
HeightHEIGHT
Tissue
Heart RateHR
Pulse RatePULSE
Respiratory RateRESP
Blood Pressure Finding
Connective and Soft Tissue
The rhythmic wave within the arteries occurring
with each contraction ofthe left ventricle.
Mean Arterial PressureMAP
Soft Tissue
The rate of the pulse as observed in an artery,
expressed as beats per minute. It can be measured
at several anatomical sites, including the wrist,
neck, temple, groin, behind the knees, or on top
of the foot.
Adipose TissueBODYFAT
NCIs Thesaurus relates concept in hierarical
structure by using super- and sub-concepts.
9
Generic dataset structure for all domainsBased
on the descriptions in the Study Data Tabulation
Model document


RecordQual
Topic
Identifier
Timing
GroupingQual
SynonymQual
Res
ResQual
Var
VarQual
VSPOS
VSLOC
VSTESTCD
VSORRES
Res
Example from CDISC SDTM Implementation Guideline
version 3.1.2
10
Hypertension can be seen as a Risk Factor in SDTM
Medical History for a specific clinical study
A CRF (Case Report Form) asks whether or not the
subject had any of a list of 4 specific risk
factors, including hypertension, and there is a
space for the investigator to write in other risk
factors. In SDTM this is classified as a
Medical History and below is an example on row 7
describing how a (sligfhly simplified) record in
a MH domain could look like
Example from CDISC SDTM Implementation Guideline
version 3.1.2
11
Pregnancy can be seen as a type of Disposition
event in SDTM domain for Disposition for a
specific clinical study
From CDISC SDTM Implementation Guideline version
3.1.2, to be published as a controlled
terminioligy
12
Primary use inDrug Development (i.e. Secondary
Use of Health Care data in clinical research)
Primary Usein Health Careper patient
Secondary Usein Health Careas Knowledge Base
Population
Subject
SDTM
Auhortities
Organizing clinical trials information that is to
be submitted to the FDA.
Patient
Secondary Usein Drug Developmentas Knowledge
Base
Secondary UseEpi / Population / Real life
analysis