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Instructions on how to use this template

  1. Copy QS Template page and move to the Initial development (not ready for review) page. Please DO NOT OVERWRITE the template pages.
    1. If the supplement is based on a measurement system, such as PRO-CTCAE V1.0, FACIT, PROMIS, etc., replace the word instrument with measurement system throughout the supplement.
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    • Numbers that begin a sentence, title, subtitle, or heading 
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    • Accepted usage such as idiomatic expressions and numbers used as pronouns 

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Information for Reviewers

Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

MTWS-R

QRS Permission StatusPublic Domain
TeamTobacco Implementation Guide (TIG) and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0 
StatusDRAFT
Date2024-01-22
Notes to Readers
  • This supplement is available to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
Known Issues


Revision History

DateVersion
2024-01-221.0 Draft

© 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) instrument.

There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF. 

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

The specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC questionnaires, ratings, and scales (QRS) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the MTWS-R in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

References for the MTWS-R:

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the MTWS-R are listed below.

The MTWS-R evaluates the effects of smoking cessation. It is a 15-item self-report measure of tobacco withdrawal. Each item is rated on a 5-point ordinal scale (0="None", 1="Slight", 2="Mild", 3="Moderate", 4="Severe"). A total score, based on 8 of these items, between 0-32 is also captured.

  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 QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the MTWS-R is typically the last 24 hours (QSEVLINT = "-PT24H")

  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 the derived score generation process, records are not included for 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 (i.e., QSTESTCDs MTWSR101 through MTWSR108). This score may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from http://www.med.uvm.edu/behaviorandhealth/research/minnesota-tobacco-withdrawal-scale.

    1. The overall score is represented in QSORRES, QSSTRESC, and QSSTRESN.
    2. If the overall score is received or derived by the sponsor, it is recommended that it is 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.
  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.

3.2 Example for the MTWS-R QS Domain Model

The MTWS-R example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the MTWS-R instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCATAll original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.


Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

Rows 49-60: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, no date is assumed for when the visit would have occurred.  The following variables --METHOD, EVLINT and EVINTX are also not represented when this happens

When the reason is collected for a not done visit, information or a row description should be added as follows:

Rows 49-60: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 --DTC for when the visit was planned.

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument, so we ask that you please review the example below.


The table represents the items from the MTWS-R instrument.

Rows 1-15: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 is calculated from the first eight symptoms.
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.

qs.xpt

qs.xpt

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011MTWSR101MTWSR1-Angry, Irritable, FrustratedMTWS-RSlight11

Y12023-08-13-PT24H
2STUDYXQS2324-P00012MTWSR102MTWSR1-Anxious, NervousMTWS-RModerate33

Y12023-08-13-PT24H
3STUDYXQS2324-P00013MTWSR103MTWSR1-Depressed Mood, SadMTWS-RMild22

Y12023-08-13-PT24H
4STUDYXQS2324-P00014MTWSR104MTWSR1-Difficulty ConcentratingMTWS-RMild22

Y12023-08-13-PT24H
5STUDYXQS2324-P00015MTWSR105MTWSR1-Inc Appetite, Hungry, Weight GainMTWS-RSlight11

Y12023-08-13-PT24H
6STUDYXQS2324-P00016MTWSR106MTWSR1-Sleep Problems/Awakening at NightMTWS-RSlight11

Y12023-08-13-PT24H
7STUDYXQS2324-P00017MTWSR107MTWSR1-RestlessMTWS-RModerate33

Y12023-08-13-PT24H
8STUDYXQS2324-P00018MTWSR108MTWSR1-ImpatientMTWS-RSlight11

Y12023-08-13-PT24H
9STUDYXQS2324-P00019MTWSR109MTWSR1-Craving to SmokeMTWS-RSevere44

Y12023-08-13-PT24H
10STUDYXQS2324-P000110MTWSR110MTWSR1-ConstipationMTWS-RSlight11

Y12023-08-13-PT24H
11STUDYXQS2324-P000111MTWSR111MTWSR1-DizzinessMTWS-RNone00

Y12023-08-13-PT24H
12STUDYXQS2324-P000112MTWSR112MTWSR1-CoughingMTWS-RSlight11

Y12023-08-13-PT24H
13STUDYXQS2324-P000113MTWSR113MTWSR1-Dreaming or NightmaresMTWS-RSlight11

Y12023-08-13-PT24H
14STUDYXQS2324-P000114MTWSR114MTWSR1-NauseaMTWS-RNone00

Y12023-08-13-PT24H
15STUDYXQS2324-P000115MTWSR115MTWSR1-Sore ThroatMTWS-RNone00

Y12023-08-13-PT24H
16STUDYXQS2324-P000116MTWSR116MTWSR1-Total Withdrawal Discomfort ScoreMTWS-R141414

Y12023-08-13-PT24H
17STUDYXQS2324-P000117MTWSR101MTWSR1-Angry, Irritable, FrustratedMTWS-R


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


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


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


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


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


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


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


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


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


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


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


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


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


NOT DONEPATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED.
22023-09-10
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

The controlled response terminology for the tests below is named MTWSR101T15OR for the variable QSORRES and MTWSR101T15STR for the variables QSSTRESN and QSSTRESC.

"All QSTESTCDs"

QSORRESQSSTRESCQSSTRESN
None00
Slight11
Mild22
Moderate33
Severe44


End of Document

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