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© 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.instrument. 

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 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.

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.

...

1. 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 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.

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

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

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

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