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	2024-02-09
Notes	This supplement is 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.

Revision History

Date	Version
2024-02-09	1.0 Draft

1 Introduction

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

There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on input from Duchenne muscular dystrophy subject matter experts. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses (text and numeric) as described on the CRF.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Functional Tests (FT) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig .

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC questionnaires, ratings, and scales (QRS) documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

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 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 CDISC inventory of QRS data standards supplements. Hence, CDISC developed FTTESTCD and FTTEST for each item based on the text on the instrument QRSSUPP-605 - Getting issue details... STATUS . 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.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

Reference for the 4-STAIR ASCEND:

McDonald CM, Henricson EK, Abresch RT, et al. The 6-minute walk test QRSSUPP-606 - Getting issue details... STATUS 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 QRSSUPP-607 - Getting issue details... STATUS .

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.

The 4-STAIR ASCEND is an instrument that records the time it takes to climb 4 standard stairs. The test also includes a clinician-rated numerical scale to record the clinician's observation on performance.

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")
For the test grade (where FTTESTCD = "A4STR104"), FTORRES is populated with the text description. The numeric rating is represented in FTSTRESC and FTSTRESN.
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 climb up 4 standard stairs" QRSSUPP-608 - Getting issue details... STATUS .
Some items on the 4-STAIR ASCEND may be 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 conditionally branched items. A record is created in ft.xpt for all items. When an item is considered a conditionally branched item, it is represented as follows:
1. QNAM = "FTCBRFL", QLABEL = "Conditionally Branched Item Flag", QVAL = "Y" (this is a FT supplemental qualifier variable related to the record). QRSSUPP-609 - Getting issue details... STATUS
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, QRSSUPP-610 - Getting issue details... STATUS 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 ASCEND form.

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.

ft.xpt

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		Y	1	2015-05-15
7	STUDYX	FT	1001-002	3	A4STR103	A4STR1-Wear Orthoses	4-STAIR ASCEND				NOT DONE		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 QRSSUPP-611 - Jira project doesn't exist or you don't have permission to view it. .	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

Dataset Debug Message

When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.

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.

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

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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 variables QRSSUPP-612 - Getting issue details... STATUS (FTORRES, FTSTRESC, and FTSTRESN) should be populated.

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"

FTORRES	FTSTRESC
Yes	Y
No	N

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

End of Document

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4-Stair Ascend (4-STAIR ASCEND) Supp V1.0