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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

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titleInformation 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.

Page properties
Title

Comfort Behavior Scale (COMFORT-B SCALE)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

COMFORT-B SCALE

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2024-0204-2008
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

DateVersion
2024-0204-20081.0 Draft

© 2023 Clinical 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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Info
titleInformation for Reviewers

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.

  1. 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. 

  2. 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.
  3. 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"). 
  4. 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".
  5. The RSREPNUM variable is used to indicate the same RSTESTSs are used in trial 1, 2, 3, and 4.

  6. Records are created in rs.xpt for every instrument item: 

    1. 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.

    2. 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.

  7. 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
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyQRSSUPP-759
    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:

    1. QNAM = “RSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a RS supplemental qualifier variable related to the record).
    2. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).


  8. 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.

    1. Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
    2. 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.

  9. Terminology

    1. RSCAT, RSTESTCD, RSTEST 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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Info

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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Dataset wrap
Namers
Rowcaps
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.
Dataset2
RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSREASNDRSMETHODRSLOBXFLRSREPNUMVISITNUMRSDTC
1STUDYXRS2324-P00011CBS0101CBS01-AlertnessCOMFORT-B SCALElightly asleep (eyes mostly closed, occasional responses)22


Y

1

12023-05-15
2STUDYXRS2324-P00012CBS0102CBS01-Calmness/AgitationCOMFORT-B SCALEslightly anxious (child shows slight anxiety)22


Y112023-05-15
3STUDYXRS2324-P00013CBS0103CBS01-Respiratory ResponseCOMFORT-B SCALEno spontaneous respiration11


Y112023-05-15
4STUDYXRS2324-P00014CBS0104CBS01-CryingCOMFORT-B SCALE





Y112023-05-15
5STUDYXRS2324-P00015CBS0105CBS01-Physical MovementCOMFORT-B SCALEoccasional, (three or fewer) slight movements22


Y112023-05-15
6STUDYXRS2324-P00016CBS0106CBS01-Muscle ToneCOMFORT-B SCALEnormal muscle tone33


Y112023-05-15
7STUDYXRS2324-P00017CBS0107CBS01-Facial TensionCOMFORT-B SCALEnormal facial tone22


Y112023-05-15
8STUDYXRS2324-P00018CBS0108CBS01-Total ScoreCOMFORT-B SCALE121212


Y112023-05-15
9STUDYXRS2324-P00019CBS0109CBS01-NRS PainCOMFORT-B SCALE555

NUMERICAL RATING SCALE 11-POINTY112023-05-15

10

STUDYXRS2324-P000110CBS0110CBS01-NISSCOMFORT-B SCALE222


Y112023-05-15

11

STUDYXRS2324-P0001

11

CBS0111CBS01-Details Sedatives/AnalgesicsCOMFORT-B SCALEMidazolamMidazolam



Y112023-05-15

12

STUDYXRS2324-P000112CBS0112CBS01-Reason AssessmentCOMFORT-B SCALEPost surgery follow-upPost surgery follow-up



Y112023-05-15

13

STUDYXRS2324-P000113CBS0101CBS01-AlertnessCOMFORT-B SCALEdeeply asleep (eyes closed, no response to changes in the environment)11


Y212023-05-15

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......2324-P0001

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.......................................

24

STUDYXRS2324-P000124CBS0112CBS01-Reason AssessmentCOMFORT-B SCALEPost surgery follow-upPost surgery follow-up



Y212023-05-15

25

STUDYXRS2324-P000125CBS0101CBS01-AlertnessCOMFORT-B SCALElightly asleep (eyes mostly closed, occasional responses)22


Y312023-05-15

...

......2324-P0001..........................................

36

STUDYXRS2324-P000136CBS0112CBS01-Reason AssessmentCOMFORT-B SCALEPost surgery follow-upPost surgery follow-up



Y312023-05-15

37

STUDYXRS2324-P000137CBS0101CBS01-AlertnessCOMFORT-B SCALElightly asleep (eyes mostly closed, occasional responses)22


Y412023-05-15

...

......2324-P0001..........................................

48

STUDYXRS2324-P000148CBS0112CBS01-Reason AssessmentCOMFORT-B SCALEPost surgery follow-upPost surgery follow-up



Y412023-05-15

49

STUDYXRS2324-P000149CBS0101CBS01-AlertnessCOMFORT-B SCALE


NOT DONE


12

50

STUDYXRS2324-P000150CBS0102CBS01-Calmness/AgitationCOMFORT-B SCALE


NOT DONE


12

51

STUDYXRS2324-P000151CBS0103CBS01-Respiratory ResponseCOMFORT-B SCALE


NOT DONE


12

52

STUDYXRS2324-P000152CBS0104CBS01-CryingCOMFORT-B SCALE


NOT DONE


12

53

STUDYXRS2324-P000153CBS0105CBS01-Physical MovementCOMFORT-B SCALE


NOT DONE


12

54

STUDYXRS2324-P000154CBS0106CBS01-Muscle ToneCOMFORT-B SCALE


NOT DONE


12

55

STUDYXRS2324-P000155CBS0107CBS01-Facial TensionCOMFORT-B SCALE


NOT DONE


12

56

STUDYXRS2324-P000156CBS0108CBS01-Total ScoreCOMFORT-B SCALE


NOT DONE


12

57

STUDYXRS2324-P000157CBS0109CBS01-NRS PainCOMFORT-B SCALE


NOT DONE


12

58

STUDYXRS2324-P000158CBS0110CBS01-NISSCOMFORT-B SCALE


NOT DONE


12

59

STUDYXRS2324-P000159CBS0111CBS01-Details Sedatives/AnalgesicsCOMFORT-B SCALE


NOT DONE


12

60

STUDYXRS2324-P000160CBS0112CBS01-Reason AssessmentCOMFORT-B SCALE


NOT DONE


12

61

STUDYXRS2324-P000161CBS0101CBS01-AlertnessCOMFORT-B SCALE


NOT DONE


22

...

......2324-P0001..........................................

72

STUDYXRS2324-P000172CBS0112CBS01-Reason AssessmentCOMFORT-B SCALE


NOT DONE


22

73

STUDYXRS2324-P000173CBS0101CBS01-AlertnessCOMFORT-B SCALE


NOT DONE


32

...

......2324-P0001..........................................

84

STUDYXRS2324-P000184CBS0112CBS01-Reason AssessmentCOMFORT-B SCALE


NOT DONE


32

85

STUDYXRS2324-P000185CBS0101CBS01-AlertnessCOMFORT-B SCALE


NOT DONE


42

...

......2324-P0001..........................................

96

STUDYXRS2324-P000196CBS0112CBS01-Reason AssessmentCOMFORT-B SCALE


NOT DONE


42

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