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Revision History

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

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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 instrument is labeled a "Behavior Rating Scale" and not a "Withdrawal Scale" because subjects (1) are confused by filling out a “withdrawal” scale prior to cessation, and (2) will sometimes not report a symptom during abstinence if they do not believe it is due to withdrawal.

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

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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 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 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 8 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 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 sponsor's responsibility to do this verification based on the instrument's user manual or instructions from the 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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4 SDTM Mapping Strategy

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