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© 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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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
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 Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-606
. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-607
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 ISO8601 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.
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 independently"climb up 4 standard stairs"
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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:
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"Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-609 FTORRES, FTSTRESC, and FTSTRESN are set to null (missing).
FTCAT, FTTESTCD, and FTTEST values are included in CDISC Controlled Terminology.
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, 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. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-610
The table represents the items from the 4-STAIR ASCEND form.
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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.
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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 variablesvariables
(FTORRES, FTSTRESC, and FTSTRESN) should be populated. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-612
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