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Title

ASSIGN Risk Score (ASSIGN CVD 10-YEAR RISK)

CDISC Reference

Clinical Classifications Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short Name

(ASSIGN CVD 10-YEAR RISK)

QRS Permission StatusPublic Domain
Team

Dyslipidemia Standards Team and CDISC QRS Sub-Team

Supplement Version2.0
StatusREVISION DRAFT
Date2023-0304-1322
Notes
  • This supplement is intended to be used with other CDISC User Guides for specific Therapeutic/Disease Areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical trials.

...

Date

Version

Summary of Changes

2023-XX-XX

2.0

ASSIGN CVD 10-YEAR RISK Final

  • Converted the supplement to the current WIKI QRS supplement template.
  • Updated RSTEST name

2016-07-14

1.0

ASSIGN CVD 10-YEAR RISK Final

  • Based on the SDS Team decision to not release the draft CC domain, but include its definition in the RS domain, all references to the CC domain were revised to the RS domain throughout this document.

2015-10-07

1.0

ASSIGN CVD 10-YEAR RISK Draft

  • from Supp V1.0 from "ASSG01-ASSIGN CVD Risk Score" to "ASSG01-ASSIGN Score" based on the published controlled terminology.
  • Replace the RSBLFL variable with the current RSLOBXFL variable.
  • The original QSEVAL assumption 3 and the variable was removed from this supplement since it is not captured on the CRF and no assumptions are made on the potential values.
  • Added a missing visit to the examples.

2016-07-142015-01-05

1.0

ASSIGN CVD 10-YEAR RISK

Draft

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

Final

  • Based on the SDS Team decision to not release the draft CC domain, but include its definition in the RS domain, all references to the CC domain were revised to the RS domain throughout this document.

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the ASSIGN CVD 10-YEAR RISK composite score of cardiovascular riskinstrument. 

The ASSIGN CVD 10-YEAR RISK does not have a CRF and the algorithm to calculate the ASSIGN CVD 10-YEAR RISK is in the public domain.

The representation of data collected for this clinical classification is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found at on the CDISC website at: (httphttps://www.cdisc.org/sdtm).   /standards/foundational/sdtmig.  

These specific implementation details for this clinical classification are meant to be used in conjunction with the SDTMIG.    All clinical classifications documentation can be found on the CDISC web site at: (httphttps://www.cdisc.org/standards/foundational/qrs).

The CDISC Intellectual Property Policy can be found on the CDISC web site at: (httphttps://www.cdisc.org/about/bylaws-and-policies).

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

...

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

2 Copyright Status

This measure is CDISC believes this instrument is to be in the public domain, but you should perform your own assessment. CDISC has included the ASSIGN Cardiovascular Disease 10-Year Risk Score (ASSIGN CVD 10-YEAR RISK) as part of CDISC Data Standards. Hence in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for the ASSIGN Cardiovascular Disease 10-Year Risk Scoreeach item based on the actual text on the instrument. There may be many versions of this questionnaire in the public domain or copyright questionnaireinstrument. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this measure consists of: (1) controlled terminology, (2) standard database structure with examples.

Note: CDISC controlled terminology Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website . (httpat: https://www.cdisc.org/standards/terminology)/controlled-terminology.

Reference for ASSIGN:

Further information about the ASSIGN CVD 10-YEAR RISK can be found in the following article: Woodward M, Brindle P, Tunstall-Pedoe H, for the SIGN group on risk estimation. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart 2007; 93: 172-176.

...

  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. The clinical classification evaluator should be stored in RS.
  3. Terminology:
    1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.

    2. The value sets for the result field are not provided in Section 4, SDTM Mapping Strategy, since there is only a single numeric percentage result.

3.2 Example for the RS Domain Model3.2 Example for the RS Domain Model

The ASSIGN CVD 10-YEAR RISK Score example below shows the terminology used to implement this clinical classification measure in the RS domain. This example shows data collected for the ASSIGN CVD 10-YEAR RISK Score for two subjects, one has only one visit and the other has two visits. The example uses CDISC controlled terminology for RSTESTCD, RSTEST, and RSCAT as well as . SCTESTCD and SCTEST are not represented here for the SIMD per assumption 2. Data that is used for input to the composite scores such as labs, vital signs, substance use, social deprivation and medical history are included in its original domain and the relationship to the RS domain should be defined using the RELREC domain.  The ASSIGN CVD 10-YEAR RISK is represented in the RS domain and is linked to the other domains in RELREC by the RSLNKID.

The table represents the items from the ASSIGN CVD 10-YEAR RISK instrument. The USUBJID = "1001-002" was not evaluated for this instrument at visit 5. Since the visit was missed, the reason for not completing the visit was not collected, so no date is assumed for when the visit would have occurred.

Dataset wrap
Namers
Dataset wrap
Namers
Rowcaps
Rows 1-2:

Represent one subject who had a risk score calculated at two different visits.

Row 3:

Represents one subject who had a risk score calculated at only one visit.

Dataset2
tableidrs.xpt
RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKIDRSTESTCDRSTESTRSCATRSORRESRSORRESURSSTRESCRSSTRESNRSSTRESURSBLFLRSSTATRSEVALRSLOBXFLVISITNUMVISITRSDTC
11001RS1001-00111ASSG0101

ASSG01-ASSIGN

CVD Risk

Score

ASSIGN CVD 10-YEAR RISK3%33%
YINVESTIGATOR1Visit 1

2012-05-10

21001RS1001-00122ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK8%88%INVESTIGATOR

5Visit 5

2012-10-08

31001RS1001-00211ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK55%5555%
YINVESTIGATOR1Visit 1

2012-04-30

41001RS1001-0022
ASSG0101ASSG01-ASSIGN ScoreASSIGN CVD 10-YEAR RISK




NOT DONE
5Visit 5


The table represents the lab items from the ASSIGN CVD 10-YEAR RISK instrument.

Represent lab values used to calculate the risk score for subject 1001-002 shown in the RS domain above.
Dataset wrap
Namelb
Dataset wrap
Namelb
Rowcaps
Rows 1-4:

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

Rows 5-6:
Dataset2
tableidlb.xpt
RowSTUDYIDDOMAINUSUBJIDLBSEQLBLNKIDLBTESTCDLBTESTLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESUVISITNUMVISITLBDTC
11001LB1001-00111CHOLCholesterol8.7mmol/L8.78.7mmol/L1Visit 1

2012-05-10

21001LB1001-00121CHOLHDLHDL Cholesterol1.7mmol/L1.71.7mmol/L1Visit 1

2012-05-10

31001LB1001-00132CHOLCholesterol8.3mmol/L8.38.3mmol/L5Visit 5

2012-10-08

41001LB1001-00142CHOLHDLHDL Cholesterol2mmol/L22mmol/L5Visit 5

2012-10-08

51001LB1001-00211CHOLCholesterol6.5mmol/L6.56.5mmol/L1Visit 1

2012-04-30

61001LB1001-002211CHOLHDLCHOLHDL Cholesterol26.15mmol/L26.1526.15mmol/L1Visit 1

2012-04-30

61001LB1001-00221CHOLHDLHDL Cholesterol2.1mmol/L2.12.1mmol/L1Visit 1

2012-04-30

The table represents the demographic items from the ASSIGN CVD 10-YEAR RISK instrument.

Dataset wrap
Namedm
Dataset wrap
Namedm
Rowcaps
Row 1:

Represents sex and age values used to calculate the risk scores for subject 1001-001 shown in the RS domain above.

Row 2:

Represents sex and age values used to calculate the risk score for subject1001-002 shown in the RS domain above.

Dataset2
tableiddm.xpt
RowSTUDYIDDOMAINUSUBJIDSUBJIDSEXBRTHDTCAGEAGEU
11001DM1001-0011F1972-06-2439YEARS
21001DM1001-0022M1947-02-0265

YEARS

The table represents the vital signs items from the ASSIGN CVD 10-YEAR RISK instrument.

Represents blood pressure values used to calculate the risk score for subject 1001-002 shown in the RS domain above.
Dataset wrap
Namevs
Dataset wrap
Namevs
Rowcaps
Rows 1-2:

Represent blood pressure values used to calculate the risk scores for subject 1001-001 shown in the RS domain above.

Row 3:
Dataset2
tableidvs.xpt

Row

STUDYIDDOMAINUSUBJIDVSSEQVSLNKIDVSTESTCDVSTESTVSORRESVSORRESUVSORRESCVSSTRESNVSSTRESUVISITNUMVISIT

VSDTC

11001VS1001-00111SYSBPSystolic Blood Pressure140mmHg140140mmHg1VISIT 1

2012-05-10

21001VS1001-00122SYSBPSystolic Blood Pressure145mmHg145145mmHg5VISIT 5

2012-10-08

31001VS1001-00211SYSBPSystolic Blood Pressure142mmHg142142mmHg1VISIT 1

2012-04-30

142mmHg1VISIT 1

2012-04-30

The table represents the medical history items from the ASSIGN CVD 10-YEAR RISK instrument.

Represent diabetes and rheumatoid arthritis medical history used to calculate the risk score for subject 1001-002 shown in the RS domain above.4
Dataset wrap
Namemh
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:
2
Dataset2
tableidmh.xpt

Row

STUDYID

DOMAIN

USUBJID

MHSEQ

MHLNKID

MHTERM

MHPRESP

MHOCCUR

VISITNUM

VISIT

MHDTC

1

MHSTDC

1001

MH

1001-001

1

1

DIABETES

Y

N

1

Visit 1

2012-05-10

MHENRTPT

MHENTPT

1

1001

MH

1001-001

2

1

1

RHEUMATOID ARTHRITIS

DIABETES

Y

N

1

Visit 1

2012-05-10

3

1001

MH

1001-001

3

2

DIABETES

Y

Y

5

Visit 5

2012-10-08

2011-01-15

ONGOING

2012-05-10

2

1001

MH

1001-001

4

2

2

1

RHEUMATOID ARTHRITIS

Y

N

1

Visit 1

2012-05-10

2011-06-15

ONGOING

2012-05-10

3

5

Visit 5

2012-10-08

5

1001

MH

1001-002

1

1

DIABETES

Y

Y

1

Visit 1

2012-04-30

6

2011-02-15

ONGOING

2012-04-30

4

1001

MH

1001-002

2

1

RHEUMATOID ARTHRITIS

Y

N

1

Visit 1

2012-

04-30
Dataset wrap
Nameapmh
RowcapsRows 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

04-30

2011-05-15ONGOING2012-04-30

The table represents the associated person's family history of stroke and coronary heart disease items used to calculate the risk scores for the ASSIGN CVD 10-YEAR RISK instrument.

datasetwrap
Dataset wrap
Nameapmh
score for subject 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

STUDYID

DOMAIN

APID

RSUBJID

MHSEQ

MHLNKID

SREL

MHTERM

MHPRESP

MHOCCUR

VISITNUM

VISIT

MHDTC

MHSTDC

MHENRTPT

MHENTPT

1

1001

APMH

AP-01

3

1001

APMH

1001-001

31

21

FAMILY MEMBER, BIOLOGICAL

STROKE

Y

N

51

Visit 51

2012-05-10-08

2010-02-20

ONGOING

2012-05-10

24

1001

APMH

AP-01

1001-001

422

1

FAMILY MEMBER, BIOLOGICAL

CORONARY HEART DISEASE

Y

N

51

Visit 51

2012-05-10

2010-10-20

ONGOING

2012-05-10-08

53

1001

APMH

AP-01

1001-002

1

1

FAMILY MEMBER, BIOLOGICAL

STROKE

Y

Y

1

Visit 1

2012-04-30

2010-06-20

ONGOING

2012-04-30

46

1001

APMH

AP-01

1001-002

2

1

FAMILY MEMBER, BIOLOGICAL

CORONARY HEART DISEASE

Y

Y

1

Visit 1

2012-04-30

2010-10-

20

ONGOING

2012-04-30

The table represents the substance use items from the ASSIGN CVD 10-YEAR RISK instrument.

Represents smoking information used to calculate the risk score for subject 1001-002 shown in the RS domain above.
Dataset wrap
Namesu
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:
Dataset2
tableidsu.xpt
RowSTUDYIDDOMAINUSUBJIDSUSEQSULNKIDSUTRTSUCATSUDOSESUDOSUSUDOSFQSUDOSFRQSUSTRTPTSUSTTPTSUENRTPTSUENTPTSUPRESPSUOCCURVISITNUMVISITSUDTC
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

The RELREC table below shows how to define the one-to-one relationship (as defined in RELTYPE), or the one-to-many relationship between the RS domain and the LB, VS, SU, and the MH domains for the ASSIGN Risk Score.

...