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  1. The original scores include a numeric rating (0-100) in increments of 10, and a definition of what the ratings represent at the scale anchors (e.g., 0 = "Strongly Disagree" and 100 = "Strongly Agree"). For the QSU-BRIEF, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. 

  2. The numeric rating scale used in the QSU-BRIEF includes text and numeric values as indicated in the SUPPQS domain with:

    QNAM = "QSANTXLO"     QNAM = "QSANTXHI"

    QNAM = "QSANVLLO"     QNAM = "QSANVLHI"
    By storing this information in SUPPQS, it is available for interpretation purposes.
    The low and high anchor text is stored in QSORRES with the numeric values stored in QSSTRESC and QSSTRESN.  All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.
  3. The time period of evaluation for the QSU-BRIEF is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the QSU-BRIEF is "DURING QUESTIONNAIRE COMPLETION" (QSEVINTX = "DURING QUESTIONNAIRE COMPLETION").
  4. Records are created in qs.xpt for every instrument item
    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

    2. Due to the variability of copyright holder and public domain derived subscore and overall score generation processes, records are not included for derived subscores or overall scores that are not provided.
  5. The QSU-BRIEF instrument includes an overall score and two subscoresthat are considered as captured data on the instrument and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from Stephen T Tiffany.

    1. Subscores and overall scores are represented in QSORRES, QSSTRESC, and QSSTRESN.
    2. If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
  6. Terminology

    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

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Dataset wrap
Nameqs
Rowcaps
Rows 11-13:Row 11 represents the subscale score for Factor 1 Scale, row 12 represents subscale score for Factor 2 Scale, and row 13 represents the General Factor Scale. 
Rows 14-26:

Represent the missing data from the QSU-BRIEF Scale for subject 2324-P0001 at visit 2. Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing
the visit was not collected, and no date is assumed for when the visit would have occurred.

Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVINTX

1

STUDYX

QS

2324-P0001

1

QSUB0101

QSUB01-Desire Cigarette Right Now

QSU-BRIEF

90

90

90



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

2

STUDYX

QS

2324-P0001

2

QSUB0102

QSUB01-Nothing Better Than Cigarette Now

QSU-BRIEF

808080

Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

3

STUDYX

QS

2324-P0001

3

QSUB0103

QSUB01-Probably Would Smoke Now

QSU-BRIEF

70

70

70



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

4

STUDYX

QS

2324-P0001

4

QSUB0104

QSUB01-Control Things Better Could Smoke

QSU-BRIEF

70

70

70



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

5

STUDYX

QS

2324-P0001

5

QSUB0105

QSUB01-All I Want Right Now Is Cigarette

QSU-BRIEF

50

50

50



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

6

STUDYX

QS

2324-P0001

6

QSUB0106

QSUB01-Have an Urge for a Cigarette

QSU-BRIEF

Strongly Agree

100

100



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

7

STUDYX

QS

2324-P0001

7

QSUB0107

QSUB01-A Cigarette Would Taste Good Now

QSU-BRIEF

80

80

80



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

8

STUDYX

QS

2324-P0001

8

QSUB0108

QSUB01-Do Anything for a Cigarette Now

QSU-BRIEF

90

90

90



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

9

STUDYX

QS

2324-P0001

9

QSUB0109

QSUB01-Smoking Make Me Less Depressed

QSU-BRIEF

80

80

80



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

10

STUDYX

QS

2324-P0001

10

QSUB0110

QSUB01-Going Smoke as Soon as Possible

QSU-BRIEF

Strongly Disagree

0

0



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

11

STUDYX

QS

2324-P0001

11

QSUB0111

QSUB01-Factor 1 Scale

QSU-BRIEF

68

68

68



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

12

STUDYX

QS

2324-P0001

12

QSUB0112

QSUB01-Factor 2 Scale

QSU-BRIEF

80

80

80



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

13

STUDYX

QS

2324-P0001

13

QSUB0113

QSUB01-General Factor Scale

QSU-BRIEF

71

71

71



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

14

STUDYX

QS

2324-P0001

14

QSUB0101

QSUB01-Desire Cigarette Right Now

QSU-BRIEF




NOT DONE

2



15

STUDYX

QS

2324-P0001

15

QSUB0102

QSUB01-Nothing Better Than Cigarette Now

QSU-BRIEF




NOT DONE



2

16

STUDYX

QS

2324-P0001

16

QSUB0103

QSUB01-Probably Would Smoke Now

QSU-BRIEF




NOT DONE

2

17

STUDYX

QS

2324-P0001

17

QSUB0104

QSUB01-Control Things Better Could Smoke

QSU-BRIEF




NOT DONE

2

18

STUDYX

QS

2324-P0001

18

QSUB0105

QSUB01-All I Want Right Now Is Cigarette

QSU-BRIEF




NOT DONE

2

19

STUDYX

QS

2324-P0001

19

QSUB0106

QSUB01-Have an Urge for a Cigarette

QSU-BRIEF




NOT DONE



2

20

STUDYX

QS

2324-P0001

20

QSUB0107

QSUB01-A Cigarette Would Taste Good Now

QSU-BRIEF




NOT DONE



2

21

STUDYX

QS

2324-P0001

21

QSUB0108

QSUB01-Do Anything for a Cigarette Now

QSU-BRIEF




NOT DONE



2

22

STUDYX

QS

2324-P0001

22

QSUB0109

QSUB01-Smoking Make Me Less Depressed

QSU-BRIEF




NOT DONE



2

23

STUDYX

QS

2324-P0001

23

QSUB0110

QSUB01-Going Smoke as Soon as Possible

QSU-BRIEF




NOT DONE

2

24

STUDYX

QS

2324-P0001

24

QSUB0111

QSUB01-Factor 1 Scale

QSU-BRIEF







2



25

STUDYX

QS

2324-P0001

25

QSUB0112

QSUB01-Factor 2 Scale

QSU-BRIEF







2



26

STUDYX

QS

2324-P0001

26

QSUB0113

QSUB01-General Factor Scale

QSU-BRIEF







2



Dataset wrap
Namesuppqs

The anchor range text and numeric values for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

Dataset2
tableidsuppqs
STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXQS2324-P0001QSTESTCDQSUB0106QSANTXHIAnchor Text HighStrongly AgreeCRF
STUDYXQS2324-P0001QSTESTCDQSUB0110QSANTXLOAnchor Text LowStrongly DisagreeCRF
STUDYXQS2324-P0001QSTESTCDQSUB0106QSANVLLOAnchor Numeric Value Low100CRF
STUDYXQS2324-P0001QSTESTCDQSUB0110QSANVLHIAnchor Numeric Value High0CRF

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