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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 | Comfort Behavior Scale (COMFORT-B SCALE) |
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CDISC Reference | Clinical Classification 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 | 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 | 2024-0204-2008 |
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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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Revision History
Date | Version |
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2024-0204-2008 | 1.0 Draft |
© 2023 Clinical 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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title | Information for Reviewers |
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The CRF is attached at the top of the Wikiwiki. When you click the paperclip image, you will find the file for the annotated CRF. |
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The COMFORT-B SCALE is a multiple-choice instrument that clinicians may use in peadiatric pediatric intensive care units to assessyoung children's pain and distress. It consists of 6 behavior items, each rated on a 5-point scale describing the different intensities of the behavior in question. Summating the 6 ratings leads to a total score between 6-30, also captured.
The scale points include a numeric rating (1-5) and a definition of what is represented by the rating (e.g., 1 = "deeply asleep (eyes closed, no response to changes in the environment)"). For the COMFORT-B SCALE, RSORRES is populated with the text description while ; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
Visual analog or numeric rating scales used within a questionnaire with a range of text and numeric values are indicated in the SUPPRS domain with:
QNAM="RSANTXLO" QNAM="RSANTXHI"
QNAM="RSANVLLO" QNAM="RSANVLHI"
By storing this information in SUPPRS, it is available for interpretation purposes.
When the value of the data being represented equals a low or high anchor value, the corresponding low and high anchor text is stored in RSORRES with the numeric values stored in RSSTRESC and RSSTRESN. All other numeric values are stored in RSORRES, RSSTRESC and RSSTRESN.- RSMETHOD is populated with "NUMERICAL RATING SCALE 11-POINT" when RSTESTCD="CBS0109". The NRS is a global pain rating scale (0 ="no pain" and 10 ="worst imaginable pain").
- In addition of to the NRS, the level of sedation (NISS="Nurse Interpretation of Sedation Score") is categorized as 1 = "insufficient sedation", 2 = "adequate sedation" and , or 3 = "oversedation".
- The RSREPNUM variable is used to indicate the same RSTESTSs are used in trial 1, 2, 3, and 4.
Records are created in rs.xpt for every instrument item:
For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE". If the reason is known, then that reason is represented in RSREASND (e.g., RSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND 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.
Some items on the COMFORT-B SCALE may be conditionally branched per the instrument instructions. Only Either Respiratory Ventilation or Crying (RSTESTCD = "CBS0103" or "CBS0104") is completed for each subject. Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | QRSSUPP-759 |
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The other will be treated as a conditionally branched item. A record is created in rs.xpt for all items. When an item is considered a conditionally branched item, it is represented as follows:
- QNAM = “RSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a RS supplemental qualifier variable related to the record).
- RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).
The COMFORT-B SCALE instrument includes a total score that is 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 Monique van Dijk en Erwin Ista.
- 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 sponsor's responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
Terminology
RSCAT, RSTESTCD, RSTEST 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.
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We are unable to make the example consistently show blue in the Wikiwiki. All examples are updated for each QRS instrument, so we ask that you please review the example below. |
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Rows 1-48: | Represent the questions from the Comfort-B Scale for subject 2324-P0001 at visit 1. Row 4 represents the conditional branching item for the item "Crying". The full representation is done for RSREPNUM=1, and partial representations are done for RSREPNUM=2, 3 and 4. | Rows 49-96: | Represent the missing data from the Comfort-B Scale for subject 2324-P0001 at visit 2. 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, and no date is assumed for when the visit would have occurred. The following The variable RSMETHOD is also not represented when this happens. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSSTAT | RSREASND | RSMETHOD | RSLOBXFL | RSREPNUM | VISITNUM | RSDTC |
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1 | STUDYX | RS | 2324-P0001 | 1 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | 2 | STUDYX | RS | 2324-P0001 | 2 | CBS0102 | CBS01-Calmness/Agitation | COMFORT-B SCALE | slightly anxious (child shows slight anxiety) | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | 3 | STUDYX | RS | 2324-P0001 | 3 | CBS0103 | CBS01-Respiratory Response | COMFORT-B SCALE | no spontaneous respiration | 1 | 1 |
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| Y | 1 | 1 | 2023-05-15 | 4 | STUDYX | RS | 2324-P0001 | 4 | CBS0104 | CBS01-Crying | COMFORT-B SCALE |
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| Y | 1 | 1 | 2023-05-15 | 5 | STUDYX | RS | 2324-P0001 | 5 | CBS0105 | CBS01-Physical Movement | COMFORT-B SCALE | occasional, (three or fewer) slight movements | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | 6 | STUDYX | RS | 2324-P0001 | 6 | CBS0106 | CBS01-Muscle Tone | COMFORT-B SCALE | normal muscle tone | 3 | 3 |
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| Y | 1 | 1 | 2023-05-15 | 7 | STUDYX | RS | 2324-P0001 | 7 | CBS0107 | CBS01-Facial Tension | COMFORT-B SCALE | normal facial tone | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | 8 | STUDYX | RS | 2324-P0001 | 8 | CBS0108 | CBS01-Total Score | COMFORT-B SCALE | 12 | 12 | 12 |
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| Y | 1 | 1 | 2023-05-15 | 9 | STUDYX | RS | 2324-P0001 | 9 | CBS0109 | CBS01-NRS Pain | COMFORT-B SCALE | 5 | 5 | 5 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 1 | 2023-05-15 | 10 | STUDYX | RS | 2324-P0001 | 10 | CBS0110 | CBS01-NISS | COMFORT-B SCALE | 2 | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | 11 | STUDYX | RS | 2324-P0001 | 11 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE | Midazolam | Midazolam |
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| Y | 1 | 1 | 2023-05-15 | 12 | STUDYX | RS | 2324-P0001 | 12 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
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| Y | 1 | 1 | 2023-05-15 | 13 | STUDYX | RS | 2324-P0001 | 13 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | deeply asleep (eyes closed, no response to changes in the environment) | 1 | 1 |
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| Y | 2 | 1 | 2023-05-15 | ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 24 | STUDYX | RS | 2324-P0001 | 24 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
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| Y | 2 | 1 | 2023-05-15 | 25 | STUDYX | RS | 2324-P0001 | 25 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
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| Y | 3 | 1 | 2023-05-15 | ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 36 | STUDYX | RS | 2324-P0001 | 36 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
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| Y | 3 | 1 | 2023-05-15 | 37 | STUDYX | RS | 2324-P0001 | 37 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
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| Y | 4 | 1 | 2023-05-15 | ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 48 | STUDYX | RS | 2324-P0001 | 48 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
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| Y | 4 | 1 | 2023-05-15 | 49 | STUDYX | RS | 2324-P0001 | 49 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 50 | STUDYX | RS | 2324-P0001 | 50 | CBS0102 | CBS01-Calmness/Agitation | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 51 | STUDYX | RS | 2324-P0001 | 51 | CBS0103 | CBS01-Respiratory Response | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 52 | STUDYX | RS | 2324-P0001 | 52 | CBS0104 | CBS01-Crying | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 53 | STUDYX | RS | 2324-P0001 | 53 | CBS0105 | CBS01-Physical Movement | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 54 | STUDYX | RS | 2324-P0001 | 54 | CBS0106 | CBS01-Muscle Tone | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 55 | STUDYX | RS | 2324-P0001 | 55 | CBS0107 | CBS01-Facial Tension | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 56 | STUDYX | RS | 2324-P0001 | 56 | CBS0108 | CBS01-Total Score | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 57 | STUDYX | RS | 2324-P0001 | 57 | CBS0109 | CBS01-NRS Pain | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 58 | STUDYX | RS | 2324-P0001 | 58 | CBS0110 | CBS01-NISS | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 59 | STUDYX | RS | 2324-P0001 | 59 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 60 | STUDYX | RS | 2324-P0001 | 60 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 61 | STUDYX | RS | 2324-P0001 | 61 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 2 | 2 |
| ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 72 | STUDYX | RS | 2324-P0001 | 72 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 2 | 2 |
| 73 | STUDYX | RS | 2324-P0001 | 73 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 3 | 2 |
| ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 84 | STUDYX | RS | 2324-P0001 | 84 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 3 | 2 |
| 85 | STUDYX | RS | 2324-P0001 | 85 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 4 | 2 |
| ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 96 | STUDYX | RS | 2324-P0001 | 96 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 4 | 2 |
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