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The ASSIGN Cardiovascular Disease 10-Year Risk Score (ASSIGN CVD 10-YEAR RISK) describes the cardiovascular risk of the subject.  The score is expressed as a percentage. 

  1. The ASSIGN Cardiovascular Disease 10-Year Risk Score is derived via an algorithm that includes labs, vital signs, medical history, substance use, social deprivation and demography. Please refer to Appendix 1 of the reference cited above for the algorithm calculation.  This is considered captured data and not a derivation.
  2. Social deprivation is represented with the Scottish Index of Multiple Deprivation (SIMD) and comes from a database which uses the postal code of the subject. The SIMD is collected and used to calculate the ASSIGN, however is considered to be a possible privacy issue.  Therefore it is not submitted and is not represented in the example below. 
  3. The clinical classification evaluator should be stored in RS.
  4. Terminology:
    1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.

3.2 Example for the RS Domain Model

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Dataset wrap
Namemh
Rowcaps
Rows 1-4:

Represent diabetes and rheumatoid arthritis medical history used to calculate the risk scores for subject 1001-001 shown in the RS domain above.

Rows 5-6:

Represent diabetes and rheumatoid arthritis medical history used to calculate the risk score for subject1001subject 1001-002 shown in the RS domain above.

Dataset2
tableidmh.xpt

Row

STUDYID

DOMAIN

USUBJID

MHSEQ

MHLNKID

MHTERM

MHPRESP

MHOCCUR

VISITNUM

VISIT

MHDTC

1

1001

MH

1001-001

1

1

DIABETES

Y

N

1

Visit 1

2012-05-10

2

1001

MH

1001-001

2

1

RHEUMATOID ARTHRITIS

Y

N

1

Visit 1

2012-05-10

3

1001

MH

1001-001

3

2

DIABETES

Y

Y

5

Visit 5

2012-10-08

4

1001

MH

1001-001

4

2

RHEUMATOID ARTHRITIS

Y

N

5

Visit 5

2012-10-08

5

1001

MH

1001-002

1

1

DIABETES

Y

Y

1

Visit 1

2012-04-30

6

1001

MH

1001-002

2

1

RHEUMATOID ARTHRITIS

Y

N

1

Visit 1

2012-04-30

Dataset wrap
Nameapmh
Rowcaps
Rows 1-4:

Represent family history of stroke and coronary heart disease used to calculate the risk scores for subject 1001-001 shown in the RS domain above.

Rows 5-6:

Represent family history of stroke and coronary heart disease used to calculate the risk score for subject1001subject 1001-002 shown in the RS domain above.

Dataset2
tableidapmh.xpt

Row

STUDYID

DOMAIN

RSUBJID

MHSEQ

MHLNKID

SREL

MHTERM

MHPRESP

MHORSUR

VISITNUM

VISIT

MHDTC

1

1001

APMH

1001-001

1

1

FAMILY MEMBER, BIOLOGICAL

STROKE

Y

N

1

Visit 1

2012-05-10

2

1001

APMH

1001-001

2

1

FAMILY MEMBER, BIOLOGICAL

CORONARY HEART DISEASE

Y

N

1

Visit 1

2012-05-10

3

1001

APMH

1001-001

3

2

FAMILY MEMBER, BIOLOGICAL

STROKE

Y

N

5

Visit 5

2012-10-08

4

1001

APMH

1001-001

4

2

FAMILY MEMBER, BIOLOGICAL

CORONARY HEART DISEASE

Y

N

5

Visit 5

2012-10-08

5

1001

APMH

1001-002

1

1

FAMILY MEMBER, BIOLOGICAL

STROKE

Y

Y

1

Visit 1

2012-04-30

6

1001

APMH

1001-002

2

1

FAMILY MEMBER, BIOLOGICAL

CORONARY HEART DISEASE

Y

Y

1

Visit 1

2012-04-30

Dataset wrap
Namesu
Rowcaps
Rows 1-2:

Represent smoking information used to calculate the risk scores for subject 1001-001 shown in the RS domain above.

Row 3:

Represents smoking information used to calculate the risk score for subject1001subject 1001-002 shown in the RS domain above.

Dataset2
tableidsu.xpt
RowSTUDYIDDOMAINUSUBJIDSUSEQSULNKIDSUTRTSUCATSUDOSESUDOSUSUDOSFQSUSTRTPTSUSTTPTSUENRTPTSUENTPTSUPRESPSUOCCURVISITNUMVISITSUDTC
11001SU1001-00111CIGARETTESTOBACCO0CIGARETTEPER DAY



YN1VISIT 12012-05-10
21001SU1001-00122CIGARETTESTOBACCO5CIGARETTEPER DAYBEFORE2012-10-08ONGOING2012-10-08YY5VISIT 52012-10-08
31001SU1001-00211CIGARETTESTOBACCO20CIGARETTEPER DAYBEFORE2012-04-30ONGOING2012-04-30YY1VISIT 1

2012-04-30

...

Dataset wrap
Namerelrec
Dataset2
tableidrelrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1

1001

RS


RSLNKID


ONE

A

2

1001

LB


LBLNKID


MANY

A

3

1001

RS


RSLNKID


ONE

B

4

1001

VS


VSLNKID


ONE

B

5

1001

RS


RSLNKID


ONE

C

6

1001

SU


SULNKID


ONE

C

7

1001

RS


RSLNKID


ONE

D

8

1001

MH


MHLNKID


MANY

D

9

1001

RS


RSLNKID


ONE

E

10

1001

APMH


MHLNKID


MANY

E

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, RSSTRESN, and RSORRESU) should be populated.

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