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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.
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- 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:
- 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.
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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. |
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| | 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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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | SUBJID | SEX | BRTHDTC | AGE | AGEU | | 1 | 1001 | DM | 1001-001 | 1 | F | 6/24/ |
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| | 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 | |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSLNKID | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSLOC | VSBLFL | VISITNUM | VSDTC |
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| 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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| Rows 1-2: | Represent smoking information used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Row 3: | Represents smoking information used to calculate the risk score for subject1001-002 shown in the RS domain above. |
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| | Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SULNKID | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFQ | 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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| Dataset2 |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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| 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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