myCSG © |Area: SDTM| Concept: QS : Questionnaires | Lesson: LEQ5D3L : SDTM QS dataset - EQ5D - 3 Levels |

  • Complete key programming of a questionnaire named EQ-5D-3L:
  • EQ-5D-3L stands for European Quality of Life Five Dimension Three Level Scale
    • It is used to assess the quality of life of a subject in 5 dimensions
      • mobility
      • self-care,
      • usual activities,
      • pain/discomfort, and
      • anxiety/depression
  • Programming includes creation of tests using arrays
  • Derivation of --LOBXFL as per SDTM IG 3.3 
  • Study day creation
  • --SEQ variable creation
  • And other general SDTM variables of QS domain

EQ5D3L : EQ-5D-3L
Question Response
Date Collected
[QSDAT_RAW]

Mobility
[EQ5D3L_1]


1-I have no problems in walking about
2-I have some problems in walking about
3-I am confined to bed
Self-care
[EQ5D3L_2]


1-I have no problems with self-care
2-I have some problems washing or dressing myself
3-I am unable to wash or dress myself
Usual activities
[EQ5D3L_3]


1-I have no problems with performing my usual activities
2-I have some problems with performing my usual activities
3-I am unable to perform my usual activities
Pain/Discomfort
[EQ5D3L_4]


1-I have no pain or discomfort
2-I have moderate pain or discomfort
3-I have extreme pain or discomfort
Anxiety/Depression
[EQ5D3L_5]


1-I am not anxious or depressed
2-I am moderately anxious or depressed
3-I am extremely anxious or depressed
Health state Visual Analog Score
[EQ5D3L_6]




SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_EQ5D3L
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'QS'
_ USUBJID Unique Subject Identifier Char Concatenate the value of STUDYID variable to SUBJECT variable with a hyphen in between.
_ QSSEQ Sequence Number Num Sort the records by USUBJID, QSCAT, QSTESTCD, QSDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject
_ QSTESTCD Question Short Name Char The responses to each question item is collected in a separate variable. We need to transform the data such that we a create a row for each question
Create a record with QSTESTCD=EQ5D0101 to store the result from EQ5D3L_1.
Create a record with QSTESTCD=EQ5D0102 to store the result from EQ5D3L_2.
Create a record with QSTESTCD=EQ5D0103 to store the result from EQ5D3L_3.
Create a record with QSTESTCD=EQ5D0104 to store the result from EQ5D3L_4.
Create a record with QSTESTCD=EQ5D0105 to store the result from EQ5D3L_5.
Create a record with QSTESTCD=EQ5D0106 to store the result from EQ5D3L_6.
_ QSTEST Question Name Char Populate as 'EQ5D01-Mobility' when QSTESTCD=EQ5D0101.
Populate as 'EQ5D01-Self-Care' when QSTESTCD=EQ5D0102.
Populate as 'EQ5D01-Usual Activities' when QSTESTCD=EQ5D0103.
Populate as 'EQ5D01-Pain/Discomfort' when QSTESTCD=EQ5D0104.
Populate as 'EQ5D01-Anxiety/Depression' when QSTESTCD=EQ5D0105.
Populate as 'EQ5D01-EQ VAS Score' when QSTESTCD=EQ5D0106.
_ QSCAT Category of Question Char Populate as "EQ-5D-3L".
_ QSORRES Finding in Original Units Char Populate using EQ5D3L_1 when creating row for QSTESTCD=EQ5D0101.
Populate using EQ5D3L_2 when creating row for QSTESTCD=EQ5D0102.
Populate using EQ5D3L_3 when creating row for QSTESTCD=EQ5D0103.
Populate using EQ5D3L_4 when creating row for QSTESTCD=EQ5D0104.
Populate using EQ5D3L_5 when creating row for QSTESTCD=EQ5D0105.
Populate using EQ5D3L_6 when creating row for QSTESTCD=EQ5D0106.
. Note for questions 1 to 5, use only the second component from the result variables when hyphen is the delimiter.
_ QSORRESU Original Units Char Set to null
_ QSSTRESC Character Result/Finding in Std Format Char Populate using EQ5D3L_1 when creating row for QSTESTCD=EQ5D0101.
Populate using EQ5D3L_2 when creating row for QSTESTCD=EQ5D0102.
Populate using EQ5D3L_3 when creating row for QSTESTCD=EQ5D0103.
Populate using EQ5D3L_4 when creating row for QSTESTCD=EQ5D0104.
Populate using EQ5D3L_5 when creating row for QSTESTCD=EQ5D0105.
Populate using EQ5D3L_6 when creating row for QSTESTCD=EQ5D0106.
. Note for questions 1 to 5, use only the first component from the result variables when hyphen is the delimiter.
_ QSSTRESN Numeric Finding in Standard Units Num Populate using QS.QSSTRESC.
_ QSSTRESU Standard Units Char Set to null
_ QSLOBXFL 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.
_ QSEVAL Evaluator Char Populate as "STUDY SUBJECT"
_ VISITNUM Visit Number Num Populate with the value from FOLDERSEQ
_ VISIT Visit Name Char Populate with the value from FOLDERNAME
_ QSDTC Date/Time of Finding Char Populate using QSDAT_RAW after converting to ISO8601 format.
_ QSDY Study Day of Finding Num Populate using QS.QSDTC and DM.RFSTDTC. If QSDTC is on or after RFSTDTC then populate with the resulting value of QSDTC-RFSTDTC+1. Else if QSDTC is before RFSTDTC then populate with the resulting value of QSDTC-RFSTDTC.
_ QSEVINTX Evaluation Interval Text Char Populate as "TODAY"
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