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3.2 Example for the 4 STAIR ASCEND FT Domain Model
The 4 STAIR ASCEND example below shows the terminology used to implement the instrument in the FT domain. This example shows the data for 1 subject collected at the baseline visit for the 4 STAIR ASCEND instrument, and data for 2 subjects who did not perform the test, one who refused and one who could not do the test because of disease progression. The example uses CDISC Controlled Terminology for FTTESTCD, FTTEST, FTORRESU, FTSTRESU,
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and FTCAT. All original results, matching the CRF item response text, are represented
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in FTORRES. This result is then
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represented as a standard numeric score
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in FTSTRESN and as a standard character representation in FTSTRESC.
The table represents the items from the 4 STAIR ASCEND form.
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This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM FT domain. It also provides guidance on how the result and unit variables (FTORRES, FTSTRESC, and FTSTRESN) should be populated.All responses for 4 STAIR ASCEND are numeric and units are predetermined for those result variables that have units. This section shows which units should be used for each FTTESTCD and FTTEST.
FTTESTCD = "A4STR101" FTTEST = "A4STR1-Was 4-Stair Ascend Performed"
FTORRES | FTSTRESC |
|---|---|
| Yes | Y |
| No, Due to disease under study | No, Due to disease under study |
FTTESTCD = "A4STR103" FTTEST = "A4STR1-Wear Orthoses"
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FTTESTCD = "A4STR104" FTTEST = "A4STR1-Test Grade"
| FTORRES | FTSTRESC | FTSTRESN |
|---|---|---|
| Unable to climb up 4 standard stairs. | 1 | 1 |
| Climbs 4 standard stairs “marking time” (climbs 1 foot at a time, with both feet on a step before moving to next step), using both arms on one or both handrails. | 2 | 2 |
| Climbs 4 standard stairs “marking time” (climbs 1 foot at a time, with both feet on a step before moving to next step), using one arm on one handrail. | 3 | 3 |
| Climbs 4 standard stairs “marking time” (climbs 1 foot at a time, with both feet on a step before moving to next step), not needing handrail. | 4 | 4 |
Climbs 4 standard stairs alternating feet, needs handrail for support. | 5 | 5 |
| Climbs 4 standard stairs alternating feet, not needing handrail support. | 6 | 6 |
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