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Title 4-Stair Ascend (4-STAIR ASCEND) CDISC Reference Functional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials QRS Short Name 4-STAIR ASCEND QRS Permission Status Public Domain Team Duchenne Muscular Dystrophy (DMD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam Supplement Version 1.0 Status DRAFT Date 20222024-0602-1509 Notes This supplement is intended available 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

© 2022 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the 4-Stair Ascend (4-STAIR ASCEND) instrument.

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The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the 4-STAIR ASCEND in the library CDISC inventory of QRS data standards supplements. Hence, CDISC developed FTTESTCD and FTTEST for each item based on the actual text on the instrument

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. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

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McDonald CM, Henricson EK, Abresch RT, et al. The 6-minute walk test

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and other clinical endpoints in duchenne muscular dystrophy: reliability, concurrent validity, and minimal clinically important differences from a multicenter study. Muscle Nerve. 2013;48(3):357-68

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.

3 The FT Domain Model

3.1 Assumptions for FT Domain Model

All assumptions and business rules described in the SDTMIG FT domain are applicable to this supplement. Additional assumptions specific to the 4-STAIR ASCEND are listed below.

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1. The numerical value for the time to complete the 4-STAIR ASCEND is recorded using ISO 8601 format in FTORRES and FTSTRESC. Because ISO 8601 format is a text format, there are no standard numeric scores or units. The sponsor enters the time on the CRF in minutes and seconds according to their protocol. (e.g., 1 minute 10 seconds is represented in the FT domain in ISO 8601 format as "T1M10S")

2. For the test grade (where FTTESTCD = "A4STR104"), FTORRES is populated with the text description. The numeric rating is represented in FTSTRESC and FTSTRESN.

3. If the entire instrument was not done, the first question on the CRF represents the reason the entire instrument was not done. If the reason not done is provided, then FTSTAT = "NOT DONE" and FTREASND is equal to the text written on the form for all the test codes. 

   1. If the test was not done due to disease, the record where FTTESTCD = "A4STR101" will have FTORRES and FTSTRESC equal to "No, Due to disease under study" and the test grade (FTTESTCD = "A4STR104") will be represented with a value of 1 = "Unable to walk independentlyclimb up 4 standard stairs"

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      .

4. Some items on the 4-STAIR ASCEND may be logically skipped conditionally branched per the instrument instructions. If the test was not done because of disease, FTTESTCD = "A4STR102" and "A4STR103" are not done and are treated as logically skipped conditionally branched items. A record is created in ft.xpt for all items. When an item is considered a logically skipped conditionally branched item, it is represented as follows:

   1. FTSTAT QNAM = "FTCBRFL", QLABEL = "NOT DONE"     Conditionally Branched Item Flag", QVAL = "Y" (this is a FT supplemental qualifier variable related to the record).FTREASND = "LOGICALLY SKIPPED ITEM"

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   2. FTORRES, FTSTRESC, and FTSTRESN are set to null (missing).

   5. Terminology:
   

   1. FTCAT, FTTESTCD, and FTTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for result and units fields is provided in Section 4, SDTM Mapping Strategy.

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, 1 who refused and 1 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 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
Name ft
Rowcaps 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 because the subject was not able to do the 4-stair ascend. The test grade is shown on row 8. Rows 9-12: Show a subject who was able to complete the test. Dataset2 Row STUDYID DOMAIN USUBJID FTSEQ FTTESTCD FTTEST FTCAT FTORRES FTSTRESC FTSTRESN FTSTAT FTREASND FTLOBXFL VISITNUM FTDTC 1 STUDYX FT 1001-001 1 A4STR101 A4STR1-Was 4-Stair Ascend Performed 4-STAIR ASCEND 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 NOT DONE REFUSED Y 1 2015-05-15 3 STUDYX FT 1001-001 3 A4STR103 A4STR1-Wear Orthoses 4-STAIR ASCEND NOT DONE REFUSED Y 1 2015-05-15 4 STUDYX FT 1001-001 4 A4STR104 A4STR1-Test Grade 4-STAIR ASCEND 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 Y 1 2015-05-15 6 STUDYX FT 1001-002 2 A4STR102 A4STR1-Time to Do 4-Stair Ascend 4-STAIR ASCEND NOT DONE LOGICALLY SKIPPED ITEM Y 1 2015-05-15 7 STUDYX FT 1001-002 3 A4STR103 A4STR1-Wear Orthoses 4-STAIR ASCEND NOT DONELOGICALLY SKIPPED ITEM Y 1 2015-05-15 8 STUDYX FT 1001-002 4 A4STR104 A4STR1-Test Grade 4-STAIR ASCEND Unable to climb up 4 standard stairs Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-611 . 1 1 Y 1 2015-05-15 9 STUDYX FT 1001-003 1 A4STR101 A4STR1-Was 4-Stair Ascend Performed 4-STAIR ASCEND Yes 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 Y 1 2015-05-15 11 STUDYX FT 1001-003 3 A4STR103 A4STR1-Wear Orthoses 4-STAIR ASCEND No N 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 Y 1 2015-05-15 The conditionally branched item flag text value for data collection needs to be populated in SUPPFT as follows. The standard terminology for QNAM and QLABEL are listed below. Dataset wrap Name suppft STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG STUDYX FT 1001-002 QSSEQ 2 FTCBRFL Conditionally Branched Item Flag Y CRF STUDYX FT 1001-002 QSSEQ 3 FTCBRFL Conditionally Branched Item Flag Y CRF

4 SDTM Mapping Strategy

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

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(FTORRES, FTSTRESC, and FTSTRESN) should be populated.

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