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| Title | ASSIGN Risk Score (ASSIGN CVD 10-YEAR RISK) |
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| CDISC Reference | Clinical Classifications Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | (ASSIGN CVD 10-YEAR RISK) |
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| QRS Permission Status | Public Domain |
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| Team | Dyslipidemia Standards Team and CDISC QRS Sub-Team |
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| Supplement Version | 2.0 |
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| Status | REVISION DRAFT |
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| Date | 2023-04-2022 |
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| 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.
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Date | Version | Summary of Changes |
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2023-XX-XX | 2.0 | ASSIGN CVD 10-YEAR RISK Final - Converted the supplement to the current WIKI QRS supplement template.
- Updated RSTEST name 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.
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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.
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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. SCTESTCD and SCTEST are not represented here for the SIMD per assumption 2.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.
The table represents the items from the ASSIGN CVD 10-YEAR RISK instrument. 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.
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| | Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTESTCD | RSTEST | RSCAT | RSORRES | RSORRESU | RSSTRESC | RSSTRESN | RSSTRESU | RSSTAT | RSBLFLRSLOBXFL | VISITNUM | VISIT | RSDTC |
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| 1 | 1001 | RS | 1001-001 | 1 | 1 | ASSG0101 | CVD Risk | ASSIGN CVD 10-YEAR RISK | 3 | % | 3 | 3 | % |
| Y | 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 | % |
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| 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 | 1 | Visit 1 | 2012-04-30 | | 4 | 1001 | RS | 1001-002 | 2 |
| ASSG0101 | ASSG01-ASSIGN Score | ASSIGN CVD 10-YEAR RISK |
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| NOT DONE |
| 5 | Visit 5 |
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The table represents the lab items from the ASSIGN CVD 10-YEAR RISK instrument.
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| 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- |
001325 51 | 2012-04-30 | 2011-02-15 | ONGOING | 2012- |
1008001425 5105 | 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 | 08 |
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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.
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tableid |
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| Row | STUDYID | DOMAIN | APID | RSUBJID | MHSEQ | MHLNKID | SREL | MHTERM | MHPRESP | MHOCCUR | VISITNUM | VISIT | MHDTC | MHSTDC | MHENRTPT | MHENTPT | 1 | 1001 | APMH | AP-01 |
| .xptRow | 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 | 31 | 21 | FAMILY MEMBER, BIOLOGICAL | STROKE | Y | N | 51 | Visit 51 | 2012-05-10-08 | 2010-02-20 | ONGOING | 2012-05-10 | 24 | 1001 | APMH | AP-01 | 1001-001 | 422 | 1 | FAMILY MEMBER, BIOLOGICAL | CORONARY HEART DISEASE | Y | N | 5 | | N | 1 | Visit 1 | 2012-05-10 | 2010-10-20 | ONGOINGVisit 5 | 2012-05-10-08 | 53 | 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 | 64 | 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 |
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The table represents the substance use items from the ASSIGN CVD 10-YEAR RISK instrument.
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| | Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SULNKID | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFQSUDOSFRQ | SUSTRTPT | SUSTTPT | SUENRTPT | SUENTPT | SUPRESP | SUOCCUR | VISITNUM | VISIT | SUDTC |
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| 1 | 1001 | SU | 1001-001 | 1 | 1 | CIGARETTES | TOBACCO | 0 | CIGARETTE | PER DAY |
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| 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 | |
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