Page properties |
---|
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 Status | Public Domain |
---|
Team | Dyslipidemia Standards Team and CDISC QRS Sub-Team |
---|
Supplement Version | 2.0 |
---|
Status | REVISION DRAFT |
---|
Date | 2023-04-2022 |
---|
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.
|
---|
|
...
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 from Supp V1.0 from "ASSG01-ASSIGN CVD Risk Score" to "ASSG01-ASSIGN Score" based on ther 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.
|
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.
|
...
- 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.
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.
...
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. 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.
dataset-dataset-wrap |
---|
|
Dataset2 |
---|
| Rowcaps |
---|
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. | Dataset2 |
---|
| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTESTCD | RSTEST | RSCAT | RSORRES | RSORRESU | RSSTRESC | RSSTRESN | RSSTRESU | RSBLFLRSSTAT | RSEVALRSLOBXFL | VISITNUM | VISIT | RSDTC |
---|
1 | 1001 | RS | 1001-001 | 1 | 1 | ASSG0101 | CVD Risk | ASSIGN CVD 10-YEAR RISK | 3 | % | 3 | 3 | % |
| YINVESTIGATOR | 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 | % |
| YINVESTIGATOR | 1 | Visit 1 | 2012-04-30 | 4 | 1001 | RS | 1001-002 | 2 |
| ASSG0101 | ASSG01-ASSIGN Score | ASSIGN CVD 10-YEAR RISK |
|
|
|
|
| NOT DONE |
| 5 | Visit 5 |
|
|
|
The The table represents the lab items from the ASSIGN CVD 10-YEAR RISK instrument.
Dataset wrap |
---|
|
Dataset2 |
---|
| | Rowcaps |
---|
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. | Dataset2 |
---|
| 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 |
|
|
The table represents the demographic items from the ASSIGN CVD 10-YEAR RISK instrument.
...
...
Represents sex and age values used to calculate the risk scores for subject 1001-001 shown in the RS domain above.
...
Represents sex and age values used to calculate the risk score for subject1001-002 shown in the RS domain above.
-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 |
|
|
The table represents the demographic items from the ASSIGN CVD 10-YEAR RISK instrument.
Dataset2 |
---|
|
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 | |
|
The table represents the vital signs items from the ASSIGN CVD 10-YEAR RISK instrument.
Dataset wrap |
---|
|
Rowcaps |
---|
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. | Dataset2 |
---|
| Row | STUDYID | DOMAIN | USUBJID | SUBJID | SEX | VSSEQBRTHDTC | VSLNKIDAGE | VSTESTCDAGEU | VSTEST1 | VSORRES1001 | VSORRESUDMVSORRESC | 1001-001 | VSSTRESN1 | VSSTRESU | VISITNUM | VISIT | VSDTC | F | 1972-06-24 | 39 | YEARS |
---|
21 | 1001 | VSDM | 1001-001 | 1 | 1 | SYSBP | Systolic Blood Pressure | 140 | mmHg | 140 | 140 | mmHg | 1 | VISIT 1 | 2012-05-10 | 002 | 2 | M | 1947-02-02 | 65 | |
|
|
The table represents the vital signs items from the ASSIGN CVD 10-YEAR RISK instrument.
Dataset wrap |
---|
|
Dataset2 |
---|
| | STUDYID | DOMAIN | USUBJID | VSSEQ | VSLNKID | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSORRESC | VSSTRESN | VSSTRESU | VISITNUM | VISIT | VSDTC |
---|
1 | 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 | 1001-002001 | 1 | 1 | SYSBP | Systolic Blood Pressure | 142 | mmHg | 142 | 142 | mmHg | 1 | VISIT 1 | 2012-04-30 |
|
|
The table represents the medical history items from the ASSIGN CVD 10-YEAR RISK instrument.
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 |
|
|
The table represents the medical history items from the ASSIGN CVD 10-YEAR RISK instrument.
Dataset wrap |
---|
|
|
Dataset wrap |
---|
|
Rowcaps |
---|
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. | Dataset2 |
---|
| 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 | Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHLNKID | MHTERM | MHPRESP | MHOCCUR | VISITNUM | VISIT | MHDTC | MHSTDC | MHENRTPT | MHENTPT | 1 | 32Y5 5-08 | 2011-01-15 | ONGOING | 2012-05-10 | 2 | 4425 5-085 | 2011-06-15 | ONGOING | 2012-05-10 | 3 | 1001 | MH | 1001-002 | 1 | 1 | DIABETES | Y | Y |
| 1 | Visit 1 | 2012-04-30 | 2011-02-15 | ONGOING |
Y | 1 | Visit 164 | 1001 | MH | 1001-002 | 2 | 1 | RHEUMATOID ARTHRITIS | Y | N | 1 | Visit 1 | 2012-04-30 |
|
|
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.
...
...
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.
...
2011-05-15 | ONGOING | 2012-04-30 |
|
|
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.
Dataset wrap |
---|
|
score for subject 1001-002 shown in the RS domain above. Dataset2 |
---|
| Row | STUDYID | DOMAIN | APID | RSUBJID | MHSEQ | MHLNKID | SREL | MHTERM | MHPRESP | MHORSURMHOCCUR | VISITNUM | VISIT | MHDTC | 1MHSTDC | MHENRTPT | MHENTPT | 1 | 1001 | APMH | 1001-001 | 1 | 1 | FAMILY MEMBER, BIOLOGICAL | STROKE | Y | N | 1 | Visit 1 | 2012-05-10 | 2 | 1001 | APMH | AP-01 | 1001-001 | 21 | 1 | FAMILY MEMBER, BIOLOGICAL | CORONARY HEART DISEASESTROKE | 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 | 2010-02-20 | ONGOING | 2012-05-10 | 24 | 1001 | APMH | AP-01 | 1001-001 | 422 | 1 | FAMILY MEMBER, BIOLOGICAL | CORONARY HEART DISEASE | Y | N | 51 | Visit 51 | 2012-05-10 | 2010-10-0820 | ONGOING | 2012-05-10 | 35 | 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 |
| |
The table represents the substance use items from the ASSIGN CVD 10-YEAR RISK instrument.
Dataset wrap |
---|
| Rowcaps |
---|
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. | Dataset2 |
---|
| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SULNKID | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFQSUDOSFRQ | SUSTRTPT | SUSTTPT | SUENRTPT | SUENTPT | SUPRESP | SUOCCUR | VISITNUM | VISIT | SUDTC |
---|
1 | 1001 | SU | 1001-001 | 1 | 1 | CIGARETTES | TOBACCO | 0 | CIGARETTE | PER DAY |
|
|
|
| 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 | |
|
|
...