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  1. The original scores include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "None"). For the MTWS-R, 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 time period of evaluation for the MTWS-R is populated in the QSEVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the MTWS-R is typically the past last 24 hours (QSEVLINT = "-P24H"). 

  3. 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.

  4. The MTWS-R instrument may include an overall score that is considered as captured data on the instrument and is not considered as derived in the example below. This overall score, or  total withdrawal discomfort score, consists of the first eight symptoms. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

    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 repsonsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.

  5. Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN 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 131-14:15:Comprise eight well-validated, primary withdrawal symptom descriptors (single items) based on DSM-5 (“Angry, irritable, frustrated;” “Anxious, nervous;” “Depressed mood, sad;” “Difficulty concentrating;” “Increased appetite, hungry, weight gain;” “Insomnia, sleep problems, awakening at night;” “Restless;” and “Impatient”) as well as nine additional symptom candidates (e.g., “Craving to smoke;” “Decreased pleasure from events;” and “Dizziness”).
Row 16:Shows the total withdrawal discomfort score calculated from the first eight symptomsItems 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX".Rows 15-16:Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".
Rows 17-32:Show the subject was not evaluated on this instrument at visit 2. Since the reason for not completing the visit was collected, the date is included in QSDTC for when the visit was planned.
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011MTWSR101MTWSR1-Angry, Irritable, FrustratedMTWS-RSlight11

Y12023-08-13-P24H
2STUDYXQS2324-P00012MTWSR102MTWSR1-Anxious, NervousMTWS-RModerate33

Y12023-08-13-P24H
3STUDYXQS2324-P00013MTWSR103MTWSR1-Depressed Mood, SadMTWS-RMild22

Y12023-08-13-P24H
4STUDYXQS2324-P00014MTWSR104MTWSR1-Difficulty ConcentratingMTWS-RMild22

Y12023-08-13-P24H
5STUDYXQS2324-P00015MTWSR105MTWSR1-Inc Appetite, Hungry, Weight GainMTWS-RSlight11

Y12023-08-13-P24H
6STUDYXQS2324-P00016MTWSR106MTWSR1-Sleep Problems/Awakening at NightMTWS-RSlight11

Y12023-08-13-P24H
7STUDYXQS2324-P00017MTWSR107MTWSR1-RestlessMTWS-RModerate33

Y12023-08-13-P24H
8STUDYXQS2324-P00018MTWSR108MTWSR1-ImpatientMTWS-RSlight11

Y12023-08-13-P24H
9STUDYXQS2324-P00019MTWSR109MTWSR1-Craving to SmokeMTWS-RSevere44

Y12023-08-13-P24H
10STUDYXQS2324-P000110MTWSR110MTWSR1-ConstipationMTWS-RSlight11

Y12023-08-13-P24H
11STUDYXQS2324-P000111MTWSR111MTWSR1-DizzinessMTWS-RNone00

Y12023-08-13-P24H
12STUDYXQS2324-P000112MTWSR112MTWSR1-CoughingMTWS-RSlight11

Y12023-08-13-P24H
13STUDYXQS2324-P000113MTWSR113MTWSR1-Dreaming or NightmaresMTWS-RSlight11

Y12023-08-13-P24H
14STUDYXQS2324-P000114MTWSR114MTWSR1-NauseaMTWS-RNone00

Y12023-08-13-P24H
15STUDYXQS2324-P000115MTWSR115MTWSR1-Sore ThroatMTWS-RNone00

Y12023-08-13-P24H
16STUDYXQS2324-P000116MTWSR116MTWSR1-Total Withdrawal Discomfort ScoreMTWS-R141414

Y12023-08-13-P24H
17STUDYXQS2324-P000117MTWSR101MTWSR1-Angry, Irritable, FrustratedMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
18STUDYXQS2324-P000118MTWSR102MTWSR1-Anxious, NervousMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
19STUDYXQS2324-P000119MTWSR103MTWSR1-Depressed Mood, SadMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
20STUDYXQS2324-P000120MTWSR104MTWSR1-Difficulty ConcentratingMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
21STUDYXQS2324-P000121MTWSR105MTWSR1-Inc Appetite, Hungry, Weight GainMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
22STUDYXQS2324-P000122MTWSR106MTWSR1-Sleep Problems/Awakening at NightMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
23STUDYXQS2324-P000123MTWSR107MTWSR1-RestlessMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
24STUDYXQS2324-P000124MTWSR108MTWSR1-ImpatientMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
25STUDYXQS2324-P000125MTWSR109MTWSR1-Craving to SmokeMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
26STUDYXQS2324-P000126MTWSR110MTWSR1-ConstipationMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
27STUDYXQS2324-P000127MTWSR111MTWSR1-DizzinessMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
28STUDYXQS2324-P000128MTWSR112MTWSR1-CoughingMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
29STUDYXQS2324-P000129MTWSR113MTWSR1-Dreaming or NightmaresMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
30STUDYXQS2324-P000130MTWSR114MTWSR1-NauseaMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
31STUDYXQS2324-P000131MTWSR115MTWSR1-Sore ThroatMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H
32STUDYXQS2324-P000132MTWSR116MTWSR1-Total Withdrawal Discomfort ScoreMTWS-R


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10-P24H



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