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The 4 STAIR DESCEND 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 DESCEND instrument, and data for 1 subject who did not perform the test. The example uses CDISC Controlled Terminology for FTTESTCD, FTTEST, FTORRESU, FTSTRESU, and FTCAT. All original results, matching the CRF item response text, are represented in FTORRES. This result is then represented as a standard numeric score in FTSTRESN and as a standard character representation in FTSTRESC.
The table represents the items from the 4 STAIR DESCEND form. USUBJID = "1001-001" did not perform the test due to the use of a wheelchair; however, the grade and orthoses question are still completed.
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Rows 1-4: | Show a subject who refused to do the test. All 4 questions were marked as not done with the reason written at the top of the CRF. | Rows 5-8: | Show a subject who was not able to do the test due to disease progression. Rows 6 and 7 are logically skipped items since the subject was not able to do the 10-Meter Walk/Run. The test grade is shown on row 8. | Rows 9-12: | Show a subject who was able to complete the test. |
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Row | STUDYID | DOMAIN | USUBJID | FTSEQ | FTTESTCD | FTTEST | FTCAT | FTORRES | FTSTRESC | FTSTRESN | FTSTAT | FTREASND | FTLOBXFL | VISITNUM | FTDTC |
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1 | STUDYX | FT | 1001-001 | 1 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4 STAIR DESCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | 2 | STUDYX | FT | 1001-001 | 2 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4 STAIR DESCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | 3 | STUDYX | FT | 1001-001 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4 STAIR DESCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | 4 | STUDYX | FT | 1001-001 | 4 | D4STR104 | D4STR1-Test Grade | 4 STAIR DESCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | 5 | STUDYX | FT | 1001-002 | 1 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4 STAIR DESCEND | No, Due to disease under study | No, Due to disease under study |
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| Y | 1 | 2015-05-15 | 6 | STUDYX | FT | 1001-002 | 2 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4 STAIR DESCEND |
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| NOT DONE | LOGICALLY SKIPPED ITEM | Y | 1 | 2015-05-15 | 7 | STUDYX | FT | 1001-002 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4 STAIR DESCEND |
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| NOT DONE | LOGICALLY SKIPPED ITEM | Y | 1 | 2015-05-15 | 8 | STUDYX | FT | 1001-002 | 4 | D4STR104 | D4STR1-Test Grade | 4 STAIR DESCEND | Unable to descend 4 standard stairs. | 1 | 1 |
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| Y | 1 | 2015-05-15 | 9 | STUDYX | FT | 1001-003 | 1 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4 STAIR DESCEND | Yes | Y |
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| Y | 1 | 2015-05-15 | 10 | STUDYX | FT | 1001-003 | 2 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4 STAIR DESCEND | PT1M32S | PT1M32S |
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| Y | 1 | 2015-05-15 | 11 | STUDYX | FT | 1001-003 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4 STAIR DESCEND | No | N |
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| Y | 1 | 2015-05-15 | 12 | STUDYX | FT | 1001-003 | 4 | D4STR104 | D4STR1-Test Grade | 4 STAIR DESCEND | Descends 4 standard stairs alternating feet, needs handrail for support. | 5 | 5 |
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| Y | 1 | 2015-05-15 |
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