myCSG © |Area: SDTM| Concept: FT : Functional Tests | Lesson: L6MWT : SDTM FT dataset - 6MWT - Six Minute Walk Test |

 

Background
  • In some clinical trials, we may have to collect data about some task-based evaluations like assessment of mobility, assessment of dexterity, or cognitive ability of subjects
  • There are several stand-alone, validated instruments (forms/questionnaires) which fall under this class of 'task-based' evaluations
  • Some examples are:
    • 10-METER WALK/RUN
    • 4-STAIR ASCEND
    • 4-STAIR DESCEND
    • Six Minute Walk Test
    • PUL (Performance of the Upper Limb Module)
    • SPPB (Short Physical Performance Battery)
    • MMSE (Mini-Mental State Examination)
  • SDTM standard has a standard domain for capturing these findings - "Functional Tests (FT)"
  • FT dataset belongs to Findings class and has an expected record structure of 'One record per Functional Test finding per time point per visit per subject'

What type of information is typically collected or presented?
  • Date of assessment
  • Test performed status
    • Yes
    • No 
      • Reason not performed
  • Short name of the test
  • Name of the test
  • Position of the subject when test was performed
  • Result
    • in original units
    • in standard units
  • Derived information
    • Baseline flag - when results of a test are collected over pre and post treatment period
 
  • Complete key programming for SDTM FT domain
    • This lesson is about a functional test named Six Minute Walk Test
    • This test examines the cumulative distance walked every minute walked up to 6 minutes
  • Programming aspects include:
    • Creation of rows for testcds from variables using arrays
    • Derivation of --LOBXFL
    • Creation of study day and other SDTM general variables

SMWT : Six Minute Walk Test
Question Response
Date Collected
[FTDAT_RAW]
Assissted Device
[SMWT_DEVICE]
Distance at 1 minute
[SMWT_1]
Distance at 2 minutes
[SMWT_2]
Distance at 3 minutes
[SMWT_3]
Distance at 4 minutes
[SMWT_4]
Distance at 5 minutes
[SMWT_5]
Distance at 6 minutes
[SMWT_6]



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_SMWT
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'FT'
_ USUBJID Unique Subject Identifier Char Concatenate the value of STUDYID variable to SUBJECT variable with a hyphen in between.
_ FTSEQ Sequence Number Num Sort the records by USUBJID, FTCAT, FTTESTCD, FTDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject
seq
_ FTTESTCD Short Name of Test Char
testcds		 Create a record with FTTESTCD=SIXMW101 to store the result from SMWT_1.
Create a record with FTTESTCD=SIXMW102 to store the result from SMWT_2.
Create a record with FTTESTCD=SIXMW103 to store the result from SMWT_3.
Create a record with FTTESTCD=SIXMW104 to store the result from SMWT_4.
Create a record with FTTESTCD=SIXMW105 to store the result from SMWT_5.
Create a record with FTTESTCD=SIXMW106 to store the result from SMWT_6.
_ FTTEST Name of Test Char Populate as 'SIXMW1-Distance at 1 Minute' when FTTESTCD=SIXMW101.
Populate as 'SIXMW1-Distance at 2 Minutes' when FTTESTCD=SIXMW102.
Populate as 'SIXMW1-Distance at 3 Minutes' when FTTESTCD=SIXMW103.
Populate as 'SIXMW1-Distance at 4 Minutes' when FTTESTCD=SIXMW104.
Populate as 'SIXMW1-Distance at 5 Minutes' when FTTESTCD=SIXMW105.
Populate as 'SIXMW1-Distance at 6 Minutes' when FTTESTCD=SIXMW106.
_ FTCAT Category Char Populate as "SIX MINUTE WALK"
_ FTORRES Result or Finding in Original Units Char Populate using SMWT_1 when creating row for FTTESTCD=SIXMW101.
Populate using SMWT_2 when creating row for FTTESTCD=SIXMW102.
Populate using SMWT_3 when creating row for FTTESTCD=SIXMW103.
Populate using SMWT_4 when creating row for FTTESTCD=SIXMW104.
Populate using SMWT_5 when creating row for FTTESTCD=SIXMW105.
Populate using SMWT_6 when creating row for FTTESTCD=SIXMW106.
_ FTORRESU Original Units Char Populate as "m"
_ FTSTRESC Result or Finding in Standard Format Char Populate with the values from FT.FTORRES
_ FTSTRESN Numeric Result/Finding in Standard Units Num Popuate with the values from FT.FTSTRESC after converting to numeric format where applicable.
_ FTSTRESU Standard Units Char Populate as "m"
_ FTLOBXFL Last Observation Before Exposure Flag Char Populate as "Y" on the latest record with non-missing result on or prior to DM.RFXSTDTC for each subject and test.
_ FTEVAL Evaluator Char Populate as "INVESTIGATOR"
_ VISITNUM Visit Number Num Populate with the value from FOLDERSEQ
_ VISIT Visit Name Char Populate with the value from FOLDERNAME
_ FTDTC Date/Time of Test Char Populate using FTDAT_RAW after converting to ISO8601 format.
_ FTDY Study Day of Test Num Populate using FT.FTDTC and DM.RFSTDTC. If FTDTC is on or after RFSTDTC then populate with the resulting value of FTDTC-RFSTDTC+1. Else if FTDTC is before RFSTDTC then populate with the resulting value of FTDTC-RFSTDTC.
Y FTASSTDV Assisted Device _isb Populate with the value from SMWT_DEVICE
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