Page properties

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 Status	Public Domain
Team	Dyslipidemia Standards Team and CDISC QRS Sub-Team
Supplement Version	2.0
Status	FINALREVISION DRAFT
Date	2023-XX04-XX22
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
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

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.

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: (http)https://www.cdisc.org/about/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 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 . (http:at: 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.

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.

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.
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.

...

Terminology:
1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.

3.2 Example for the RS Domain Model

1. 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 Model

The 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

Name	rs

Dataset2

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

tableid	rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTESTCD	RSTEST	RSCAT	RSORRES	RSORRESU	RSSTRESC	RSSTRESN	RSSTRESU	RSBLFLRSSTAT	RSEVALRSLOBXFL	VISITNUM	VISIT	RSDTC
1	1001	RS	1001-001	1	1	ASSG0101	ASSG01-ASSIGN CVD Risk Score	ASSIGN CVD 10-YEAR RISK	3	%	3	3	%		Y	INVESTIGATOR	1	Visit 1	2012-05-10
2	1001	RS	1001-001	2	2	ASSG0101	ASSG01-ASSIGN CVD Risk Score	ASSIGN CVD 10-YEAR RISK	8	%	8	8	%INVESTIGATOR			5	Visit 5	2012-10-08
3	1001	RS	1001-002	1	1	ASSG0101	ASSG01-ASSIGN CVD Risk Score	ASSIGN CVD 10-YEAR RISK	55	%	55	55	%		Y	INVESTIGATOR	1	Visit 1	2012-04-30
4	1001	RS	1001-002	2		ASSG0101	ASSG01-ASSIGN Score	ASSIGN CVD 10-YEAR RISK						NOT DONE		5	Visit 5

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

Dataset wrap

Name	lb

Dataset2

tableid	lb.xpt

Dataset wrap

Name	lb

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:

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

Dataset2

tableid	LB

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBLNKID	LBTESTCD	LBTEST	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	VISITNUM	VISIT	LBDTC
1	1001	LB	1001-001	1	1	CHOL	Cholesterol	8.7	mmol/L	8.7	8.7	mmol/L	1	Visit 1	2012-05-10
2	1001	LB	1001-001	2	1	CHOLHDL	HDL Cholesterol	1.7	mmol/L	1.7	1.7	mmol/L	1	Visit 1	2012-05-10
3	1001	LB	1001-001	3	2	CHOL	Cholesterol	8.3	mmol/L	8.3	8.3	mmol/L	5	Visit 5	2012-10-08
4	1001	LB	1001-001	4	2	CHOLHDL	HDL Cholesterol	2	mmol/L	2	2	mmol/L	5	Visit 5	2012-10-08
5	1001	LB	1001-002	1	1	CHOL	Cholesterol	6.5	mmol/L	6.5	6.5	mmol/L	1	Visit 1	2012-04-30
6	1001	LB	1001-002	2	1	CHOLHDL	HDL Cholesterol	2.1	mmol/L	2.1	2.1	mmol/L	1	Visit 1	2012-04-30

The

...

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

Dataset wrap

Name	dm

Dataset2

tableid	dm.xpt

Row	STUDYID	DOMAIN	USUBJID	SUBJID	SEX	BRTHDTC	AGE	AGEU
1	1001	DM	1001-001	1	F	1972-06-24	39	YEARS
2	1001	DM	1001-002	2	M	1947-02-02	65	YEARS

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

...

Dataset wrap

Name	dm

Dataset2

tableid	dm.xpt

Row	STUDYID	DOMAIN	USUBJID	SUBJID	SEX	BRTHDTC	AGE	AGEU
1	1001	DM	1001-001	1	F	6/24/1972	39	YEARS
2	1001	DM	1001-002	2	M	2/2/1947	65	YEARS

The following dataset represents source-data vital signs tests that were input into the APACHE II. Note that the result values fall within the ranges contained in RSORRES in the corresponding RS record. VSLNKID matches RSLNKID for each corresponding record in the RS domain example above.

...

Name	vs

...

Row

...

STUDYID

...

DOMAIN

...

USUBJID

...

VSSEQ

...

VSLNKID

...

VSTESTCD

...

VSTEST

...

VSORRES

...

VSORRESU

...

VSSTRESC

...

VSSTRESN

...

VSSTRESU

...

VSLOC

...

VSBLFL

...

VISITNUM

...

VSDTC

...

The following dataset represents the 7 source-data lab tests that were input into the APACHE II. Note that the result values fall within the ranges contained in RSORRES in the corresponding RS record. LBLNKID matches RSLNKID for each corresponding record in the preceding RS domain example.

The following dataset represents the one-to-one relationship (as defined in RELTYPE) between the RS and VS domains and between the RS and LB domains for the APACHE II.

Dataset wrap

Name	relrecvs

Dataset2

tableid	vs.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID	1	STUDYX	RS	RSLNKID	ONE	1	2	STUDYX	VS	VSLNKID	ONE	1	3	STUDYX	RS	RSLNKID	ONE	2	4	STUDYX	LB	LBLNKID	ONE	2

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.

RSTESTCD = "APCH101" RSTEST = "APCH1-Temperature - Rectal"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH102" RSTEST = "APCH1-Mean Arterial Pressure"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH103" RSTEST = "APCH1-Heart Rate"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH104" RSTEST = "APCH1-Respiratory Rate"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH105A" RSTEST = "APCH1-Oxygenation: A-aDO2"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH105B" RSTEST = "APCH1-Oxygenation: PaO2"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH106A" RSTEST = "APCH1-Arterial pH"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH106B" RSTEST = "APCH1-Serum HCO3"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH107" RSTEST = "APCH1-Serum Sodium"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH108" RSTEST = "APCH1-Serum Potassium"

RSORRES	RSSTRESC	RSSTRESN
>=7	4	4
6-6.9	3	3
5.5-5.9	1	1
3.5-5.4	0	0
3-3.4	1	1
2.5-2.9	2	2
<2.5	4	4

...

RSTESTCD = "APCH109" RSTEST = "APCH1-Serum Creatinine"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

	DOMAIN	USUBJID	VSSEQ	VSLNKID	VSTESTCD	VSTEST	VSORRES	VSORRESU	VSORRESC	VSSTRESN	VSSTRESU	VISITNUM	VISIT	VSDTC
1	1001	VS	1001-001	1	1	SYSBP	Systolic Blood Pressure	140	mmHg	140	140	mmHg	1	VISIT 1	2012-05-10
2	1001	VS	1001-001	2	2	SYSBP	Systolic Blood Pressure	145	mmHg	145	145	mmHg	5	VISIT 5	2012-10-08
3	1001	VS	1001-002	1	1	SYSBP	Systolic Blood Pressure	142	mmHg	142	142	mmHg	1	VISIT 1	2012-04-30

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

Dataset wrap

Name	mh

Dataset2

tableid	mh.xpt

Row	STUDYID	DOMAIN	USUBJID	MHSEQ	MHLNKID	MHTERM	MHPRESP	MHOCCUR	VISITNUM	VISIT	MHDTC	MHSTDC	MHENRTPT	MHENTPT
1	1001	MH	1001-001	1	1	DIABETES	Y	N	1	Visit 1	2012-05-10	2011-01-15	ONGOING	2012-05-10
2	1001	MH	1001-001	2	1	RHEUMATOID ARTHRITIS	Y	N	1	Visit 1	2012-05-10	2011-06-15	ONGOING	2012-05-10
3	1001	MH	1001-002	1	1	DIABETES	Y	Y	1	Visit 1	2012-04-30	2011-02-15	ONGOING	2012-04-30
4	1001	MH	1001-002	2	1	RHEUMATOID ARTHRITIS	Y	N	1	Visit 1	2012-04-30	2011-05-15	ONGOING	2012-04-30

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.

Dataset wrap

Name	apmh

Dataset2

tableid	apmh.xpt

Row	STUDYID	DOMAIN	APID	RSUBJID	MHSEQ	MHLNKID	SREL	MHTERM	MHPRESP	MHOCCUR	VISITNUM	VISIT	MHDTC	MHSTDC	MHENRTPT	MHENTPT
1	1001	APMH	AP-01	1001-001	1	1	FAMILY MEMBER, BIOLOGICAL	STROKE	Y	N	1	Visit 1	2012-05-10	2010-02-20	ONGOING	2012-05-10
2	1001	APMH	AP-01	1001-001	2	1	FAMILY MEMBER, BIOLOGICAL	CORONARY HEART DISEASE	Y	N	1	Visit 1	2012-05-10	2010-10-20	ONGOING	2012-05-10
3	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
4	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.

Dataset wrap

Name	su

Dataset2

tableid	su.xpt

Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SULNKID	SUTRT	SUCAT	SUDOSE	SUDOSU	SUDOSFRQ	SUSTRTPT	SUSTTPT	SUENRTPT	SUENTPT	SUPRESP	SUOCCUR	VISITNUM	VISIT	SUDTC
1	1001	SU	1001-001	1	1	CIGARETTES	TOBACCO	0	CIGARETTE	PER DAY					Y	N	1	VISIT 1	2012-05-10
2	1001	SU	1001-001	2	2	CIGARETTES	TOBACCO	5	CIGARETTE	PER DAY	BEFORE	2012-10-08	ONGOING	2012-10-08	Y	Y	5	VISIT 5	2012-10-08
3	1001	SU	1001-002	1	1	CIGARETTES	TOBACCO	20	CIGARETTE	PER DAY	BEFORE	2012-04-30	ONGOING	2012-04-30	Y	Y	1	VISIT 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.

Dataset wrap

Name	relrec

Dataset2

tableid	relrec.xpt

Row	STUDYID	RDOMAIN	IDVAR	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

...

RSTESTCD = "APCH110" RSTEST = "APCH1-Hematocrit"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH111" RSTEST = "APCH1-White Blood Count"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH114" RSTEST = "APCH1-B: Age Points"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH115" RSTEST = "APCH1-C: Chronic Health Points"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

End of Document

Page tree

Versions Compared

Old Version 15

New Version Current

Key

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The RS Domain Model

3.1 Assumptions for Disease Response and Clin Classification Domain Model

3.2 Example for the RS Domain Model

3.2 Example for the RS Domain Model

4 SDTM Mapping Strategy

Page tree

Page History

Versions Compared

Old Version 15

New Version Current

Key

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The RS Domain Model

3.1 Assumptions for Disease Response and Clin Classification Domain Model

3.2 Example for the RS Domain Model

3.2 Example for the RS Domain Model

4 SDTM Mapping Strategy