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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 | Standards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and 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 | 2023-12-2930 (date current version released, regardless of status - this date should always match the date in the Revision History section below and should be updated every time this supplement is edited.) |
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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
| Date | Version |
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| 2023-12-2930 | 1.0 Draft |
© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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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 rating scales used within a questionnaire with a range of text and numeric values are 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 numeric values stored in QSSTRESC and QSSTRESN. All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.- Items are divided into 2 subcategories represented in QSSCAT: "FACTOR 1 SCALE", and "FACTOR 2 SCALE". (Note: Remove this if 3.1.6 is applicable. If this remains include QSSCAT in 3.1.7 and 3.2)
- 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 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.
The QRS 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, --STRESC, and --STRESN.
- 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 qualifier, timing, result, and unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)
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The table represents the items from the QRS Short_NameQSU-BRIEF instrument.
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| Rowcaps |
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| Rows 1-13-14:: | Represent the questions from the QSU-Brief Scale for subject 2324-P0001 at visit 1. Row 11 represents the total score for Factor 1, row 12 represents total score for Factor 2 and row 13 represents the Overall Global Score Items 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". | | Row 33: | The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF. | |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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| 1 | STUDYX | QS | 2324-P0001 | 1 |
IDSR101IDSR1-Falling Asleep | IDS-SR | I never take longer than 30 minutes to fall asleep | 0 | | QSUB01-Desire Cigarette Right Now | QSU-BRIEF | 70 | 70 | 70 |
0-P7D| DURING QUESTIONNAIRE COMPLETION | | 2 | STUDYX | QS | 2324-P0001 | 2 |
IDSR102IDSR1-Sleep During the Night | IDS-SR | I do not wake up at night | 0 | | QSUB01-Nothing Better Than Cigarette Now | QSU-BRIEF | 60 | 60 | 60 |
0-P7D| DURING QUESTIONNAIRE COMPLETION | | 3 | STUDYX | QS | 2324-P0001 | 3 |
IDSR103IDSR1-Waking Up Too Early | IDS-SR | Most of the time, I awaken no more than 30 minutes before I need to get up| QSUB01-Probably Would Smoke Now | QSU-BRIEF | Strongly Disagree | 0 | 0 | Y | 1 | 2015-05-15 |
-P7D| DURING QUESTIONNAIRE COMPLETION | | 4 | STUDYX | QS | 2324-P0001 | 4 |
IDSR104IDSR1-Sleeping Too Much | IDS-SR | I sleep no longer than 7-8 hours/night, without napping during the day | 0 | | QSUB01-Control Things Better Could Smoke | QSU-BRIEF | 60 | 60 | 60 |
0-P7D| DURING QUESTIONNAIRE COMPLETION | | 5 | STUDYX | QS | 2324-P0001 | 5 |
IDSR105IDSR1-Feeling Sad | IDS-SR | I feel sad less than half the time | 1 | | QSUB01-All I Want Right Now Is Cigarette | QSU-BRIEF | 80 | 80 | 80 |
1-P7D| DURING QUESTIONNAIRE COMPLETION | | 6 | STUDYX | QS | 2324-P0001 | 6 |
IDSR106IDSR1- Feeling Irritable | IDS-SR | I feel irritable less than half the time | 1 | | QSUB01-Have an Urge for a Cigarette | QSU-BRIEF | Strongly Agree | 100 | 100 |
1-P7D| DURING QUESTIONNAIRE COMPLETION | | 7 | STUDYX | QS | 2324-P0001 | 7 |
IDSR107IDSR1-Feeling Anxious or Tense | IDS-SR | I feel anxious (tense) less than half the time | 1 | | QSUB01-A Cigarette Would Taste Good Now | QSU-BRIEF | 50 | 50 | 50 |
1-P7D| DURING QUESTIONNAIRE COMPLETION | | 8 | STUDYX | QS | 2324-P0001 | 8 |
IDSR108IDSR1-Your Mood to Good/Desired Events | IDS-SR | My mood brightens but I do not feel like my normal self when good events occur | 1 | | QSUB01-Do Anything for a Cigarette Now | QSU-BRIEF | 80 | 80 | 80 |
1-P7D| DURING QUESTIONNAIRE COMPLETION | | 9 | STUDYX | QS | 2324-P0001 | 9 |
IDSR109IDSR1-Mood in Relation to Time of Day | IDS-SR | My mood often relates to the time of day because of environmental events (e.g., being alone, working) | 1 | | QSUB01-Smoking Make Me Less Depressed | QSU-BRIEF | 70 | 70 | 70 |
1-P7D| DURING QUESTIONNAIRE COMPLETION | | 10 | STUDYX | QS | 2324-P0001 | 10 |
IDSR109AIDSR1-Mood Worse Morn/Afternoon/Night | IDS-SR | Afternoon | | QSUB01-Going Smoke as Soon as Possible | QSU-BRIEF | Strongly Disagree | 0 | 0 |
Afternoon-P7D| DURING QUESTIONNAIRE COMPLETION | | Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.) |
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| | 33 | STUDYX | QS | 2324-P0001 | 33 | IDSR131 | IDSR1-Score | IDS-SR | 18 | 18 | 18 | Y | 1 | 2015-05-15 |
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| Info |
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The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes): Text that would remain unchanged has been left in black: The evaluation interval text value 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 | P0001 | QSSEQ | Sequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8) | Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT). | Label for QNAM (e.g., Contact Type) | Value of QNAM variable ( e.g., SUBJECT VISIT) | CRF | |
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