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

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This document describes the CDISC implementation of the 4-Stair Descend (4-STAIR DESCEND) instrument.

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CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the 4-STAIR DESCEND in the library of QRS data standards supplements. Hence, CDISC developed FTTESTCD and FTTEST for each item based on the actual text on the instrument. 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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All assumptions and business rules described in the SDTMIG FT domain are applicable to this supplement. Additional assumptions specific to the 4-STAIR DESCEND are listed below.

4-STAIR DESCEND is an instrument that records the time it takes to descend 4 standard stairs, and is used to assess stair-descending ability. The test also includes a clinician-rated numerical scale to record the clinician’s observation on performance.

1. The numerical value for the time to complete the 4-STAIR DESCEND is recorded using ISO8601 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 = "D4STR104"), 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 = "D4STR101" will have FTORRES and FTSTRESC equal to "No, Due to disease under study" and the test grade (FTTESTCD = "D4STR104") will be represented with a value of 1 = "Unable to walk independently".

4. Some items on the 4-STAIR DESCEND may be logically skipped per the instrument instructions. If the test was not done because of disease, FTTESTCD = "D4STR102" and "D4STR103" are not done and are treated as logically skipped items. A record is created in ft.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:

   1. FTSTAT = "NOT DONE"     

   2. FTREASND = "LOGICALLY SKIPPED ITEM"
      

   3. FTORRES, FTSTRESC, and FTSTRESN are set to null

   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 DESCEND FT Domain Model

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.

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FTTESTCD = "D4STR101" FTTEST = "D4STR1-Was 4-Stair Descend Performed"

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