You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 12 Next »

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
StatusFINAL
Date2023-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

© 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. 

  • 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

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKIDRSTESTCDRSTESTRSCATRSORRESRSORRESURSSTRESCRSSTRESNRSSTRESURSBLFLRSEVALVISITNUMVISITRSDTC
11001RS1001-00111ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK3%33%YINVESTIGATOR1Visit 15/10/12
21001RS1001-00122ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK8%88%
INVESTIGATOR5Visit 510/8/12
31001RS1001-00211ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK55%5555%YINVESTIGATOR1Visit 1

4/30/12

$warningHtml

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

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDSEXBRTHDTCAGEAGEU
11001DM1001-0011F6/24/197239YEARS
21001DM1001-0022M2/2/194765

YEARS

$warningHtml


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

vs.xpt

Row

STUDYID

DOMAIN

USUBJID

VSSEQ

VSLNKID

VSTESTCD

VSTEST

VSORRES

VSORRESU

VSSTRESC

VSSTRESN

VSSTRESU

VSLOC

VSBLFL

VISITNUM

VSDTC

1STUDYXVSP00011AP01TEMPTemperature38.9C38.938.9CRECTUMY12014-06-24
2STUDYXVSP00012AP02MAPMean Arterial Pressure117mmHg117117mmHg
Y12014-06-24
3STUDYXVSP00013AP03HRHeart Rate98beats/min9898beats/min
Y12014-06-24
4STUDYXVSP00014AP04RESPRespiratory Rate54breaths/min5454breaths/min
Y12014-06-24
$warningHtml


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.


lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBSEQ

LBLNKID

LBTESTCD

LBTEST

LBORRES

LBORRESU

LBSTRESC

LBSTRESN

LBSTRESU

LBSPEC

LBBLFL

VISITNUM

LBDTC

1STUDYXLBP00011AP05PO2Partial Pressure Oxygen65mmHg6565mmHgARTERIAL BLOODY12014-06-24
2STUDYXLBP00012AP06PHpH7.12
7.127.12
ARTERIAL BLOODY12014-06-24
3STUDYXLBP00013AP07SODIUMSodium150mmol/L150150mmol/LSERUMY12014-06-24
4STUDYXLBP00014AP08KPotassium3.7mmol/L3.73.7mmol/LSERUMY12014-06-24
5STUDYXLBP00015AP09CREATCreatinine0.5mg/dL0.50.5mg/dLSERUMY12014-06-24
6STUDYXLBP00016AP10HCTHematocrit24.6%24.624.6%
Y12014-06-24
7STUDYXLBP00017AP11WBCLeukocytes4210^9/L424210^9/L
Y12014-06-24
$warningHtml

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.


$titleHtml

relrec.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALRELTYPERELID
1STUDYXRS
RSLNKID
ONE1
2STUDYXVS
VSLNKID
ONE1
3STUDYXRS
RSLNKID
ONE2
4STUDYXLB
LBLNKID
ONE2
$warningHtml

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

>=4144
39-40.933
38.5-38.911
36-38.400
34-35.911
32-33.922
30-31.933
<=29.944
RSORRESU
C

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

RSORRES

RSSTRESC

RSSTRESN

>=16044
130-15933
110–12922
70–10900
50–6922
<=4944
RSORRESU
mmHg

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

RSORRES

RSSTRESC

RSSTRESN

>=18044
140–17933
110–13922
70–10900
55–6922
40–5433
<=3944
RSORRESU
beats/min

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

RSORRES

RSSTRESC

RSSTRESN

>=5044
35-4933
25-3411
12-2400
10-1111
6-922
<=544
RSORRESU
breaths/min

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

RSORRES

RSSTRESC

RSSTRESN

>=50044
350-49933
200-34922
<20000
RSORRESU
mmHg

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

RSORRES

RSSTRESC

RSSTRESN

>7000
61-7011
55-6033
<5544
RSORRESU
mmHg

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

RSORRES

RSSTRESC

RSSTRESN

>=7.744
7.6-7.6933
7.5-7.5911
7.33-7.4900
7.25-7.3222
7.15-7.2433
<7.1544

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

RSORRES

RSSTRESC

RSSTRESN

>=5244
41-51.933
32-40.911
22-31.900
18-21.922
15-17.933
<1544
RSORRESU
mmol/L

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

RSORRES

RSSTRESC

RSSTRESN

>=18044
160-17933
155-15922
150-15411
130-14900
120-12922
111-11933
<=11044
RSORRESU
mmol/L

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

RSORRES

RSSTRESC

RSSTRESN

>=744
6-6.933
5.5-5.911
3.5-5.400
3-3.411
2.5-2.922
<2.544
RSORRESU
mmol/L

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

RSORRES

RSSTRESC

RSSTRESN

>=3.5 and acute renal failure88
2-3.4 and acute renal failure66
1.5-1.9 and acute renal failure44
>=3.544
2-3.433
1.5-1.922
0.6-1.400
<0.622
RSORRESU
mg/dL

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

RSORRES

RSSTRESC

RSSTRESN

>=6044
50-59.922
46-49.911
30-45.900
20-29.922
<2044
RSORRESU
%

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

RSORRES

RSSTRESC

RSSTRESN

>=4044
20-39.922
15-19.911
3-14.900
1-2.922
<144
RSORRESU
10^9/L

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

RSORRES

RSSTRESC

RSSTRESN

<=4400
45-5422
55-6433
65-7455
>=7566
RSORRESU
YEARS

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

RSORRES

RSSTRESC

RSSTRESN

for nonoperative or emergency postoperative patients55
for elective postoperative patients22


End of Document

  • No labels