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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 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.
The table represents the items from the ASSIGN CVD 10-YEAR RISK instrument.
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| 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. |
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| | Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTESTCD | RSTEST | RSCAT | RSORRES | RSORRESU | RSSTRESC | RSSTRESN | RSSTRESU | RSBLFL | RSEVAL | VISITNUM | VISIT | RSDTC |
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| 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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The table represents the lab items from the ASSIGN CVD 10-YEAR RISK instrument.
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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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xxxThe table represents the demographic items from the ASSIGN CVD 10-YEAR RISK instrument.
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| Row 1: | Represents sex and age values used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Row 2: | Represents sex and age values used to calculate the risk score for subject1001-002 shown in the RS domain above. |
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| | Row | STUDYID | DOMAIN | USUBJID | SUBJID | SEX | BRTHDTC | AGE | AGEU | | 1 | 1001 | DM | 1001-001 | 1 | F | 1972-06-24 | 39 | YEARS | | 2 | 1001 | DM | 1001-002 | 2 | M | 1947-02-02 | 65 | |
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The table represents the vital signs items from the ASSIGN CVD 10-YEAR RISK instrument.
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| Rows 1-2: | Represent blood pressure values used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Row 3: | Represents blood pressure values used to calculate the risk score for subject 1001-002 shown in the RS domain above. |
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| | STUDYID | DOMAIN | USUBJID | VSSEQ | VSLNKID | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSORRESC | VSSTRESN | VSSTRESU | VISITNUM | VISIT | VSDTC |
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| 1 | 1001 | VS | 1001-001 | 1 | 1 | SYSBP | Systolic Blood Pressure | 140 | mmHg | 140 | 140 | mmHg | 1 | VISIT 1 | 2012-05-10 | | 2 | 1001 | VS | 1001-001 | 2 | 2 | SYSBP | Systolic Blood Pressure | 145 | mmHg | 145 | 145 | mmHg | 5 | VISIT 5 | 2012-10-08 | | 3 | 1001 | VS | 1001-002 | 1 | 1 | SYSBP | Systolic Blood Pressure | 142 | mmHg | 142 | 142 | mmHg | 1 | VISIT 1 | 2012-04-30 |
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The table represents the medical history items from the ASSIGN CVD 10-YEAR RISK instrument.
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| Rows 1-4: | Represent diabetes and rheumatoid arthritis medical history used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Rows 5-6: | Represent diabetes and rheumatoid arthritis medical history used to calculate the risk score for subject 1001-002 shown in the RS domain above. |
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| Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHLNKID | MHTERM | MHPRESP | MHOCCUR | VISITNUM | VISIT | MHDTC | 1 | 1001 | MH | 1001-001 | 1 | 1 | DIABETES | Y | N | 1 | Visit 1 | 2012-05-10 | 2 | 1001 | MH | 1001-001 | 2 | 1 | RHEUMATOID ARTHRITIS | Y | N | 1 | Visit 1 | 2012-05-10 | 3 | 1001 | MH | 1001-001 | 3 | 2 | DIABETES | Y | Y | 5 | Visit 5 | 2012-10-08 | 4 | 1001 | MH | 1001-001 | 4 | 2 | RHEUMATOID ARTHRITIS | Y | N | 5 | Visit 5 | 2012-10-08 | 5 | 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 | 2012-04-30 |
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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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| Rows 1-4: | Represent family history of stroke and coronary heart disease used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Rows 5-6: | Represent family history of stroke and coronary heart disease used to calculate the risk score for subject 1001-002 shown in the RS domain above. |
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| Row | 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 | 3 | 2 | FAMILY MEMBER, BIOLOGICAL | STROKE | Y | N | 5 | Visit 5 | 2012-10-08 | 4 | 1001 | APMH | 1001-001 | 4 | 2 | FAMILY MEMBER, BIOLOGICAL | CORONARY HEART DISEASE | Y | N | 5 | Visit 5 | 2012-10-08 | 5 | 1001 | APMH | 1001-002 | 1 | 1 | FAMILY MEMBER, BIOLOGICAL | STROKE | Y | Y | 1 | Visit 1 | 2012-04-30 | 6 | 1001 | APMH | 1001-002 | 2 | 1 | FAMILY MEMBER, BIOLOGICAL | CORONARY HEART DISEASE | Y | Y | 1 | Visit 1 | 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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| 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 subject 1001-002 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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