Note the below modeling approach can be used in all body-system domains when abnormalities are identified through examination of an image produced by an imaging procedure.
| Dataset wrap |
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| title | cv.xpt |
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| Name | TUBody-System Domain |
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| Rowcaps |
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| Row 1: | Shows one or more lesions have been identified in the lower limb region at Visit 1. |
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| Row 2: | Shows lesion 1 is found in the left popliteal artery, below the knee. |
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| Row 3: | Shows lesion 2 is found in the right femoral artery. |
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| Row 4: | Shows one or more lesions have been identified in the lower limb region at Visit 4 |
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| Row 5: | Shows after treatment, lesion 1 is not detected, hence RESLOC is not populated, suggesting the treatment had worked. |
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| Row 6: | Shows lesion 2 is still present at the right femoral artery. |
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| Row 7: | Shows there are no more lesions identified in the lower limb region at Visit 8. |
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| Row 8: | Shows after treatments, lesion 1 is not detected, hence RESLOC is not populated, suggesting the treatment had worked. |
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| Row 9: | Shows after treatments, lesion 2 is not detected, hence RESLOC is not populated, suggesting the treatment had worked. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | --SEQ | --LNKID | --TEST | --LOC | --ORRES | --STRESC | --Result LOC | --Result LAT | --Result LOCDTL | METHOD | EVEL | VISITNUM | VISIT | TUDTCDTC |
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| 1 | TUDY01 |
| any body system domain | 40912 | 1 |
| Abnormality Indicator | LOWER LIMB REGION | Y | Y |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | 2 | TUDY01 |
| any body system domain | 40912 | 2 | Lesion 1 | Examination for Abnormality | LOWER LIMB REGION | lesion (or aneurism aneurysm, etc) | lesion | POPLITEAL ARTERY | LEFT | BELOW THE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | 3 | TUDY01 |
| any body system domain | 40912 | 3 | Lesion 2 | Examination for Abnormality | LOWER LIMB REGION | lesion | lesion | FEMORAL ARTERY | RIGHT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | 4 | TUDY01 |
| any body system domain | 40912 | 4 |
| Abnormality Indicator | LOWER LIMB REGION | Y | Y |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 5 | VISIT 4 | 2007-04-07 | | 5 | TUDY01 |
| any body system domain | 40912 | 5 | Lesion 1 | Examination for Abnormality | LOWER LIMB REGION | lesion not detected | lesion not detected |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 5 | VISIT 4 | 2007-04-07 | | 6 | TUDY01 |
| any body system domain | 40912 | 6 | Lesion 2 | Examination for Abnormality | LOWER LIMB REGION | lesion | lesion | FEMORAL ARTERY | RIGHT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 5 | VISIT 4 | 2007-04-07 | | 7 | TUDY01 |
| any body system domain | 40912 | 7 |
| Abnormality Indicator | LOWER LIMB REGION | N | N |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 9 | VISIT 8 | 2007-10-08 | | 8 | TUDY01 |
| any body system domain | 40912 | 8 | Lesion 1 | Examination for Abnormality | LOWER LIMB REGION | lesion not detected | lesion not detected |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 9 | VISIT 8 | 2007-10-08 | | 9 | TUDY01 |
| any body system domain | 40912 | 9 | Lesion 2 | Examination for Abnormality | LOWER LIMB REGION | lesion not detected | lesion not detected |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 9 | VISIT 8 | 2007-10-08 |
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...
| Pros: | - Reusibility of the result location variables in other domains when needed.
- Simplicity: there is only one location for TULOC (Test)LOC for the Lesion/abnormality Location Identification process. Imaging location is treated as the general location for TULOC--LOC, and all result locations are under the RESLOC variable.
- The ability to represent different "types" of lesions abnormalities in TUORRESORRES, i.e. aneurysm, calcified annulus or calcified valvular leaflets, stenosis, or an actual cardiovascular lesion (plaque causing stenosis), etc. This approach enables us to avoid creating "lesionabnormality-type" specific TUTESTs--TESTs, such as aneurysm location identificationindicator, calcification location identificationindicator, etc.
- Because we are dealing with a "lesion (TU) domain", the TUTEST= Lesion Indicator, is created as a "general question" that would allow users to create a record on whether or not a lesion is present in a region. As mentioned in bullet point 3, a lesion can be an aneurysm, calcified annulus or valvular leaflets, stenosis and so on - so TUTEST = Lesion Indicator is all encompassing. This TUTEST also allows users to create a The ability to create a negative record when the lesion abnormality is no longer detectable after treatmentsobserved.
- This approach aligns the most with what happens in reality (the assessment of an image to find abnormalities).
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| Cons: | - We currently have DIR, LAT, PORTOT, Loc Detail, how many more LOC-related variables might we need if there are more complicated locations info that we need to represent. For example, the graft use-case where we need to indicate a location being a graft, or transplant, we created a NSV for that.
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Additional
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concerns to
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address:
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- Controlled terminology: finalize the
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- details for the test = Examination for Abnormality.
- Team needs to think about the implication of this approach
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- . The cardiovascular common data element projects (both CV-imaging and Endpoints TAs) contained many "indicator" values such as the following: aneurysm indicator, Cusp Prolapse Indicator, Cardiac Muscle Hypertrophy Indicator, Aortic Coarctation Indicator, Mitral valve stenosis Indicator, Mitral valve regurgitation indicator, pleural effusion indicator, etc, where the responses are "Y/N". At the time (well, still) CDISC treated this type of data as "pre-specified findings" and the modeling approach was to create "XXX Indicator" type of questions. However, the question has always been: are there really "pre-specified findings" from observing an image? Did you plan to find an aneurysm from the chest CT scan? Did you plan to find pleural effusion in the pleural cavity? What was planned was an imaging procedure, such as a chest CT scan, and during this diagnostic procedure, abnormalities were identified. The observed abnormalities are results from examining the image, is it correct to treat these "results" as TESTs by creating pre-specified finding indicator questions, i.e. aneurysm indicator?
- If what we proposed below is the way forward, CDISC will move away from creating "Indicator" type of questions for findings resulted from examination of an image.
For example, for the existing test: Blood Regurgitation Indicator, results are Y/N. Using the new modeling approach, it would look like the following:
Row | STUDYID | DOMAIN | USUBJID | SEQ | LNKID | TEST | LOC | ORRES | STRESC | Result LOC | METHOD | EVEL | VISITNUM | VISIT | TUDTC |
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| 1 |
...
|
| any body system domain | 40912 | 1 |
| Abnormality Indicator | LOWER LIMB REGION | Y | Y |
| ECHO | INVESTIGATOR |
...
...
TUDY01
| any body system domain | 40912 | 2 |
| Examination for Abnormality | LOWER LIMB REGION | blood regurgitation | blood regurgitation | Mitral Valve | ECHO | INVESTIGATOR |
...
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|
| any body system domain | 40912 | 1 |
| Abnormality Indicator | LOWER LIMB REGION | N | N |
| ECHO | INVESTIGATOR | 2 | VISIT |
...
...
...
|
| any body system domain | 40912 | 2 |
| Examination for Abnormality | LOWER LIMB REGION | blood regurgitation not detected | blood regurgitation not detected | Mitral Valve | ECHO | INVESTIGATOR | 2 | VISIT |
...
...