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
Date2023-03-13
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.


Revision History

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

2015-01-05

1.0

ASSIGN CVD 10-YEAR RISK Draft

© 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 risk. 

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) RS domain model, which can be found at the CDISC website at: (http://www.cdisc.org/sdtm).   

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: (http://www.cdisc.org/qrs).

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

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers.  Please see Appendix F of the SDTMIG for a complete version of this material. 

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 in the public domain. CDISC has included the ASSIGN Cardiovascular Disease 10-Year Risk Score (ASSIGN CVD 10-YEAR RISK) as part of CDISC Data Standards. Hence, CDISC developed RSTESTCD and RSTEST for the ASSIGN Cardiovascular Disease 10-Year Risk Score. There may be many versions of this questionnaire in the public domain or copyright questionnaire. 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 is maintained by NCI EVS. The most recent version should be accessed through the CDISC website. (http://www.cdisc.org/terminology)

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.

3 The RS Domain Model

3.1 Assumptions for Disease Response and Clin Classification Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement.  Additional assumptions specific to the ASSIGN Cardiovascular Disease 10-Year Risk Score (ASSIGN CVD 10-YEAR RISK) are listed below.

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

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 for SIMD. 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.

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.

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKIDRSTESTCDRSTESTRSCATRSORRESRSORRESURSSTRESCRSSTRESNRSSTRESURSBLFLRSEVALVISITNUMVISITRSDTC
11001RS1001-00111ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK3%33%YINVESTIGATOR1Visit 1

2012-05-10

21001RS1001-00122ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK8%88%
INVESTIGATOR5Visit 5

2012-10-08

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

2012-04-30

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:

Represent lab values used to calculate the risk score for subject 1001-002 shown in the RS domain above.

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

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

2012-04-30

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.

RowSTUDYIDDOMAINUSUBJIDSUBJIDSEXBRTHDTCAGEAGEU
11001DM1001-0011F1972-06-2439YEARS
21001DM1001-0022M1947-02-0265

YEARS

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:

Represents blood pressure values used to calculate the risk score for subject 1001-002 shown in the RS domain above.

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

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 subject 1001-002 shown in the RS domain above.

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

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 subject 1001-002 shown in the RS domain above.

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

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 subject 1001-002 shown in the RS domain above.

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

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.

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


End of Document