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	FINAL
Date	2023-XX-XX
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

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.

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.
The clinical classification evaluator should be stored in RS.
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.

rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTESTCD	RSTEST	RSCAT	RSORRES	RSORRESU	RSSTRESC	RSSTRESN	RSSTRESU	RSBLFL	RSEVAL	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

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Dataset Wrapper Debug Message

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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.

lb.xpt

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

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The following dataset represents source-data GCS scores which were input into the APACHE II. Note that RSSEQ is set to start at 101 for each subject within this split RS domain as APACHE II is only collected once during the study (at VISITNUM=1). RSGRPID in the split domain below matches RSGRPID for the corresponding record in the preceding RS domain example.

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

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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.

vs.xpt

Row	STUDYID	DOMAIN	USUBJID	VSSEQ	VSLNKID	VSTESTCD	VSTEST	VSORRES	VSORRESU	VSSTRESC	VSSTRESN	VSSTRESU	VSLOC	VSBLFL	VISITNUM	VSDTC
1	STUDYX	VS	P0001	1	AP01	TEMP	Temperature	38.9	C	38.9	38.9	C	RECTUM	Y	1	2014-06-24
2	STUDYX	VS	P0001	2	AP02	MAP	Mean Arterial Pressure	117	mmHg	117	117	mmHg		Y	1	2014-06-24
3	STUDYX	VS	P0001	3	AP03	HR	Heart Rate	98	beats/min	98	98	beats/min		Y	1	2014-06-24
4	STUDYX	VS	P0001	4	AP04	RESP	Respiratory Rate	54	breaths/min	54	54	breaths/min		Y	1	2014-06-24

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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.

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relrec.xpt

Row	STUDYID	RDOMAIN	IDVAR	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

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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
>=41	4	4
39-40.9	3	3
38.5-38.9	1	1
36-38.4	0	0
34-35.9	1	1
32-33.9	2	2
30-31.9	3	3
<=29.9	4	4

RSORRESU
C

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

RSORRES	RSSTRESC	RSSTRESN
>=160	4	4
130-159	3	3
110–129	2	2
70–109	0	0
50–69	2	2
<=49	4	4

RSORRESU
mmHg

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

RSORRES	RSSTRESC	RSSTRESN
>=180	4	4
140–179	3	3
110–139	2	2
70–109	0	0
55–69	2	2
40–54	3	3
<=39	4	4

RSORRESU
beats/min

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

RSORRES	RSSTRESC	RSSTRESN
>=50	4	4
35-49	3	3
25-34	1	1
12-24	0	0
10-11	1	1
6-9	2	2
<=5	4	4

RSORRESU
breaths/min

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

RSORRES	RSSTRESC	RSSTRESN
>=500	4	4
350-499	3	3
200-349	2	2
<200	0	0

RSORRESU
mmHg

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

RSORRES	RSSTRESC	RSSTRESN
>70	0	0
61-70	1	1
55-60	3	3
<55	4	4

RSORRESU
mmHg

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

RSORRES	RSSTRESC	RSSTRESN
>=7.7	4	4
7.6-7.69	3	3
7.5-7.59	1	1
7.33-7.49	0	0
7.25-7.32	2	2
7.15-7.24	3	3
<7.15	4	4

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

RSORRES	RSSTRESC	RSSTRESN
>=52	4	4
41-51.9	3	3
32-40.9	1	1
22-31.9	0	0
18-21.9	2	2
15-17.9	3	3
<15	4	4

RSORRESU
mmol/L

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

RSORRES	RSSTRESC	RSSTRESN
>=180	4	4
160-179	3	3
155-159	2	2
150-154	1	1
130-149	0	0
120-129	2	2
111-119	3	3
<=110	4	4

RSORRESU
mmol/L

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

RSORRESU
mmol/L

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

RSORRES	RSSTRESC	RSSTRESN
>=3.5 and acute renal failure	8	8
2-3.4 and acute renal failure	6	6
1.5-1.9 and acute renal failure	4	4
>=3.5	4	4
2-3.4	3	3
1.5-1.9	2	2
0.6-1.4	0	0
<0.6	2	2

RSORRESU
mg/dL

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

RSORRES	RSSTRESC	RSSTRESN
>=60	4	4
50-59.9	2	2
46-49.9	1	1
30-45.9	0	0
20-29.9	2	2
<20	4	4

RSORRESU
%

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

RSORRES	RSSTRESC	RSSTRESN
>=40	4	4
20-39.9	2	2
15-19.9	1	1
3-14.9	0	0
1-2.9	2	2
<1	4	4

RSORRESU
10^9/L

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

RSORRES	RSSTRESC	RSSTRESN
<=44	0	0
45-54	2	2
55-64	3	3
65-74	5	5
>=75	6	6

RSORRESU
YEARS

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

RSORRES	RSSTRESC	RSSTRESN
for nonoperative or emergency postoperative patients	5	5
for elective postoperative patients	2	2

End of Document

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ASSIGN Risk Score (ASSIGN CVD 10-YEAR RISK)

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3.1 Assumptions for Disease Response and Clin Classification Domain Model

3.2 Example for the RS Domain Model

4 SDTM Mapping Strategy