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| Title | 4-Stair Ascend (4-STAIR ASCEND) |
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| CDISC Reference | Functional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Public Domain |
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| Team | Duchenne Muscular Dystrophy (DMD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 2022-06-0103 |
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| 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. |
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Revision History
| Date | Version |
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2022-06-0103
| 1.0 Draft |
© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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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 1 who refused and one 1 who could not do the test because of disease progression. 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.
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| Dataset wrap |
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| Rowcaps |
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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 because the subject was not able to do the 4-Stair Ascendstair ascend. The test grade is shown on row 8. | | Rows 9-12: | Show a subject who was able to complete the test. | |
| Dataset2 |
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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 | A4STR101 | A4STR1-Was 4-Stair Ascend Performed | 4-STAIR ASCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 2 | STUDYX | FT | 1001-001 | 2 | A4STR102 | A4STR1-Time to Do 4-Stair Ascend | 4-STAIR ASCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 3 | STUDYX | FT | 1001-001 | 3 | A4STR103 | A4STR1-Wear Orthoses | 4-STAIR ASCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 4 | STUDYX | FT | 1001-001 | 4 | A4STR104 | A4STR1-Test Grade | 4-STAIR ASCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 5 | STUDYX | FT | 1001-002 | 1 | A4STR101 | A4STR1-Was 4-Stair Ascend Performed | 4-STAIR ASCEND | 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 | A4STR102 | A4STR1-Time to Do 4-Stair Ascend | 4-STAIR ASCEND |
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| NOT DONE | LOGICALLY SKIPPED ITEM | Y | 1 | 2015-05-15 | | 7 | STUDYX | FT | 1001-002 | 3 | A4STR103 | A4STR1-Wear Orthoses | 4-STAIR ASCEND |
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| NOT DONE | LOGICALLY SKIPPED ITEM | Y | 1 | 2015-05-15 | | 8 | STUDYX | FT | 1001-002 | 4 | A4STR104 | A4STR1-Test Grade | 4-STAIR ASCEND | Unable to climb 4 up standard stairs. | 1 | 1 |
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| Y | 1 | 2015-05-15 | | 9 | STUDYX | FT | 1001-003 | 1 | A4STR101 | A4STR1-Was 4-Stair Ascend Performed | 4-STAIR ASCEND | Yes |
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| Y | 1 | 2015-05-15 | | 10 | STUDYX | FT | 1001-003 | 2 | A4STR102 | A4STR1-Time to Do 4-Stair Ascend | 4-STAIR ASCEND | PT13S | PT13S | PT13S |
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| Y | 1 | 2015-05-15 | | 11 | STUDYX | FT | 1001-003 | 3 | A4STR103 | A4STR1-Wear Orthoses | 4-STAIR ASCEND | No | N |
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| Y | 1 | 2015-05-15 | | 12 | STUDYX | FT | 1001-003 | 4 | A4STR104 | A4STR1-Test Grade | 4-STAIR ASCEND | 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 |
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| Y | 1 | 2015-05-15 |
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