color coding
Green = Recent FDA Changes
Pink = Instructional information for developers
Blue = Text can change from supplement to supplement based on the instrument
Black = Standard template language
Instructions on how to use this template
- Copy QS Template page and move to the Initial development (not ready for review) page. Please DO NOT OVERWRITE the template pages.
- 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.
- The "–" in this template represents the domain implemented for the instrument. This is replaced with the 2-character domain abbreviation of FT, QS, or RS that is used for the instrument.
- Change the title of the page as follows:
- Remove 'Copy of QRS Supplement Template - '.
- Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
- Change 'QRS Short_Name' to the short name (--CAT) for the current instrument.
- Update the information in the Page Properties block below as indicated in the block below.
- The supplement version number in the header section will be 'v1' if there has never been a supplement for the instrument before. Otherwise, increment as appropriate.
- If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.
- Replace 'Title' and 'QRS Short_Name' throughout the document with the title and short name of the instrument that the supplement is being created for.
- Replace royal blue text with information pertaining to the instrument the supplement is being created for. Delete royal blue text which does not apply to the new instrument.
- Unless otherwise noted, text in black applies to all QRS Supplements and should not be deleted, but should be examined carefully and revised as appropriate based on the specific instrument supplement as needed. Any changes need to be in blue font to stand out for review.
- Change QS to RS or FT and 'Questionnaires' to 'Disease Response and Clin Classification' or 'Functional Tests' as appropriate.
- Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
- Keep changes in blue for ease throughout internal and public review. Once the supplement has gone thru public review and all comments are resolved, change all text color to black except for hyperlinks.
- Arabic numerals (0, 1, 2, 3, etc.) are used to express numbers in most circumstances. Exceptions are the following:
- Numbers that begin a sentence, title, subtitle, or heading
Common fractions
Accepted usage such as idiomatic expressions and numbers used as pronouns
- Other uses of “one” in running text (e.g., when meaning "a")
- Ordinals first through ninth
- Numbers spelled out in quotes or published titles.
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.
Revision History
| Date | Version |
|---|---|
| 2024-mm-dd | 1.0 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.
Include the following statements as standalone paragraphs for copyrighted instruments:
CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.
CDISC acknowledges [insert the name of the copyright holder, in blue text] (e.g., Dr. A. J. Rush, at the UT Southwestern Medical Center) for the approval to include the QRS Short_Name in the CDISC data standards.
Only include the actual references and all material used in developing the supplement on the reference section below. This should be a reference paper or a website reference in place of a paper.
Reference for the MTWS-R:
Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) (Hughes JR. Measurement of the effects of abstinence from tobacco. A qualitative review. Psychol Addict Behav 2007;21:127-137).
This is an example only. Use the reference from the CDISC definition of the --CAT.
- do not include the parentheses.
- do not include copyright information from the definition about copyright holder and version since that's already included above.
- do add a period to the end.
If there are multiple references, please use the following format:
References for the QRS Short_Name:
- CDISC Controlled Terminology reference.
- additional reference.
Notes on the use of quotation marks:
- Use for text values of a Likert scale: e.g., ...with response options ranging from “never” to “daily."
- Actual numbers of the scale (e.g., 0-3) do not appear in quotation marks while the definitions of these anchors (e.g., 5 = “I always fall asleep”) do.
- Enclose values for variables within quotation marks (e.g., QSTESTCD = "IPA0102")
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.
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.
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 = "-P24H").
Records are created in qs.xpt for every instrument item:
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.
- 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.
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.].
- Subscores and overall scores are represented in QSORRES, QSSTRESC, and QSSTRESN.
- 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.
Terminology
QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN values are included in CDISC Controlled Terminology.
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 QSCAT. All 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.
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"
| QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| None | 0 | 0 |
| Slight | 1 | 1 |
| Mild | 2 | 2 |
| Moderate | 3 | 3 |
| Severe | 4 | 4 |
End of Document
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