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| title | Instructions on how to use this template |
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- 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 titlesRemove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
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| title | Information for Reviewers |
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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. |
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| Title | Brief Questionnaire of Smoking Urges (QSU-BRIEF) |
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| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Approved |
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| Team | Tobacco Standards Teamand CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 2024-01-0607 |
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| 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.
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| Known Issues | Only include this row to describe any known issues related to the supplement. If there are no issues, this row can be deleted. |
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Revision History
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| 2024-01-0607 | 1.0 Draft |
© 2023 Clinical 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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This document describes the CDISC implementation of the Brief Questionnaire of Smoking Urges (QSU-BRIEF) instrument.
CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
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All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the QRS the QSU-BRIEF are listed below.
The QRS QSU-BRIEF is a self-report instrument used to assess the severity of craving to smoke. The QSU-Brief Form is intended to represent the two factors contained in the longer, 32-item QSU (Tiffany & Drobes, 1991). This brief form contains 10 items, each rated on a 100-point scale in increments of 10 ranging from 0 = "Strongly Disagree" to 100 = "Strongly Agree". Factor 1 Scale is represented by the average score of items 1, 3, 6, 7, and 10, and denotes a strong desire and inclination to smoke where smoking is perceived as rewarding for active smokers. the Factor 2 Scale is represented by the average score of items 4, 8, and 9, and denotes the anticipation of relief from the negative effects of smoking and the urgent desire to smoke, . The General Factor Scale presents a total urges score and is represented by the overall average score derived from all 10 items.
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 QRS 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.
Numeric The numeric rating scales used within a questionnaire with a range of text scale used in the QSU-BRIEF includes text and numeric values are 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 low and high numeric values stored in QSSTRESC and QSSTRESN. All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.- The time period of evaluation for the QRS 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 The evaluation interval for the QRS QSU-BRIEF is "DURING QUESTIONNAIRE COMPLETION" (QSEVINTX = "DURING QUESTIONNAIRE COMPLETION").
- 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.
TheQRS 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.
- Subscores and overall scores are represented in --ORRES, --STRESCQSORRES, QSSTRESC, and --STRESNQSSTRESN.
- 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 responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
Terminology
QSCAT, QSTESTCD, and 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
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QSU-BRIEF QS Domain Model
The QRS QSU-BRIEFexample 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 QRS the QSU-BRIEF 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.
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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. |
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please review the example below. |
The table represents the items from the QSU-BRIEF instrument.
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| Rows 1-13: | Represent the questions from the QSU-Brief Scale for subject 2324-P0001 at visit 1. Row 11 represents the subscale total score for Factor 1, row 12 represents subscale total score for Factor 2 and row 13 represents the Overall Global Score. | | Row 14: | Represent the missing datsa data from the QSU-BRIEF Scale for subject 2324-P0001 at visit 21. Since the reason for not completing the visit was collected, the date is included in --DTC for when the visit was planned. QSDTC for when the visit was planned. | | 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. |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVINTX |
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| 1 | STUDYX | QS | 2324-P0001 | 1 | QSUB0101 | QSUB01-Desire Cigarette Right Now | QSU-BRIEF | 90 | 90 | 90 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | | 2 | STUDYX | QS | 2324-P0001 | 2 | QSUB0102 | QSUB01-Nothing Better Than Cigarette Now | QSU-BRIEF | 50 | 50 |
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| NOT DONE | SUBJECT REFUSED50 | 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | | 11 | STUDYX | QS | 2324-P0001 | 11 | QSUB0111 | QSUB01-Factor 1 Scale | QSU-BRIEF | 68 | 68 | 68 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | | 12 | STUDYX | QS | 2324-P0001 | 12 | QSUB0112 | QSUB01-Factor 2 Scale | QSU-BRIEF | 80 | 80 | 80 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | | 13 | STUDYX | QS | 2324-P0001 | 13 | QSUB0113 | QSUB01-General Factor Scale | QSU-BRIEF | 68 | 68 | 68 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | 14 | STUDYX | QS | 2324-P0001 | 1 | QSUB0101 | QSUB01-Desire Cigarette Right Now | QSU-BRIEF | NOT DONE | SUBJECT REFUSED | 2 | 2015-05-15 |
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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. | Dataset wrap |
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| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0106 | QSANTXLO | Anchor Text Low | Strongly Disagree | CRF | | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0110 | QSANTXHI | Anchor Text High | Strongly Agree | CRF | | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0106 | QSANVLLO | Anchor Numeric Value Low | 0 | CRF | | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0110 | QSANVLHI | Anchor Numeric Value High | 100 | CRF |
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