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Instructions on how to use this template

  1. Copy QS Template page and move to the Initial development (not ready for review) page. Please DO NOT OVERWRITE the template pages.
    1. 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.
  2. 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.
  3. Change the title of the page as follows:
    1. Remove 'Copy of QRS Supplement Template - '.
    2. Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
    3. Change 'QRS Short_Name' to the short name (--CAT) for the current instrument.
  4. Update the information in the Page Properties block below as indicated in the block below.
    1. 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.
    2. If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.
  5. 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.
  6. 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.
  7. 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.
  8. Change QS to RS or FT and 'Questionnaires' to 'Disease Response and Clin Classification' or 'Functional Tests' as appropriate.
  9. Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
  10. 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.
  11. 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.

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
Date2023-10-23 (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.)
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.
  • This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (COA #XXX, Qualified Clinical Outcome Assessments (COA) | FDA) (Use only for instruments this applies to; update COA #.)


Revision History

DateVersion
2023-10-231.0 Draft

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

1 Introduction

This document describes the CDISC implementation of the Comfort Behavior Scale 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.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Clinical Classification (RS) 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 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.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

2 Copyright Status

Monique van Dijk en Erwin Ista owns the copyright for the COMFORT-B SCALE instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument.

These materials discuss and/or include one or more of the Comfort Behavior Scale (COMFORT-B SCALE), which are owned exclusively by Monique van Dijk en Erwin Ista. No part of the COMFORT-B SCALE may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Monique van Dijk en Erwin Ista and payment of any applicable fees. Copyright Monique van Dijk en Erwin Ista. All rights reserved.

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.

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 Monique van Dijk en Erwin Ista for the approval to include the COMFORT-B SCALE in the CDISC data standards.

Reference for the COMFORT-B SCALE:

  • Boerlage AA, Ista E, Duivenvoorden HJ, de Wildt SN, Tibboel D, van Dijk M. The COMFORT behaviour scale detects clinically meaningful effects of analgesic and sedative treatment. Eur J Pain. 2015 Apr;19(4):473-9.
  • Van Dijk M, Peters JW, van Deventer P, Tibboel D. The COMFORT Behavior Scale: a tool for assessing pain and sedation in infants. Am J Nurs 2005; 105 (1): 33-6.


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 RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the Comfort Behavior Scale are listed below.

The Comfort Behavior Scale is a multiple-choice instrument that clinicians may use in peadiatric intensive care units to assess young children's pain and distress. It consists of 7 items, each rated on a 5-point scale. A total score between 7-35 is also captured.

  1. Include a description of scale score or other possible responses (You may need multiple numbered points for this, though the IDS-SR did not.). For scale scores use the following language: 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. The RSREPNUM variable is used to indicate the same RSTESTSs are used in trial 1, 2, 3, and 4.
  3. 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 score generation processes, records are not included for derived subscores or total scores that are not provided.
  4. Some items on the COMFORT-B SCALE may be conditionally branched per the instrument instructions. Only Respiratory Ventilation or Crying (RSTESTCD = "CBS0103" or "CBS0104") is completed for each subject. 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:

    When assigned with conditionally branched responses are not documented in the instrument’s instructions or a user manual:

    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).

    When assigned conditionally branched responses are documented in instructions or a user manual:

    1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a QS supplemental qualifier variable).
    2. The QSORRES responses are represented as follows:
      1. For severity items, QSORRES = "None".
      2. For interference items, QSORRES = "Not at all".
    3. If numeric response values are assigned, they are represented here: QSSTRESC = 0 and QSSTRESN = 0.

       or if no numeric responses are assigned: QSSTRESC = NULL and QSSTRESN = NULL.

  5. Include this point if score(s) are submitted to SDTM. Update blue text: 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 [Insert copyright holder's name or other source.].

    1. Subtotal and total scores are represented in--ORRES, --STRESC, and --STRESN.
    2. If 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 responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
  6. Terminology

    1. RSCAT, RSTESTCD, RSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, resultand 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.)

3.2 Example for the COMFORT-B SCALE RS Domain Model

The COMFORT-B SCALE example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit for the COMFORT-B SCALE instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCATAll original results, matching the CRF item response text, are represented in RSORRES. This result is then represented as a standard numeric score in RSSTRESN and as a standard character representation in RSSTRESC.


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 13-24: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 variable RSMETHOD is 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 COMFORT-B SCALE instrument.

Rows 13-14: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.

rs.xpt

rs.xpt

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-P00011CBS0101CBS01-AlertnessCOMFORT-B SCALE


NOT DONE


12

14

STUDYXRS2324-P00012CBS0102CBS01-Calmness/AgitationCOMFORT-B SCALE


NOT DONE


12

15

STUDYXRS2324-P00013CBS0103CBS01-Respiratory ResponseCOMFORT-B SCALE


NOT DONE


12

16

STUDYXRS2324-P00014CBS0104CBS01-CryingCOMFORT-B SCALE


NOT DONE


12

17

STUDYXRS2324-P00015CBS0105CBS01-Physical MovementCOMFORT-B SCALE


NOT DONE


12

18

STUDYXRS2324-P00016CBS0106CBS01-Muscle ToneCOMFORT-B SCALE


NOT DONE


12

19

STUDYXRS2324-P00017CBS0107CBS01-Facial TensionCOMFORT-B SCALE


NOT DONE


12

20

STUDYXRS2324-P00018CBS0108CBS01-Total ScoreCOMFORT-B SCALE


NOT DONE


12

21

STUDYXRS2324-P00019CBS0109CBS01-NRS PainCOMFORT-B SCALE


NOT DONE


12

22

STUDYXRS2324-P000110CBS0110CBS01-NISSCOMFORT-B SCALE


NOT DONE


12

23

STUDYXRS2324-P000111CBS0111CBS01-Details Sedatives/AnalgesicsCOMFORT-B SCALE


NOT DONE


12

24

STUDYXRS2324-P000112CBS0112CBS01-Reason AssessmentCOMFORT-B SCALE


NOT DONE


12

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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 SUPPRS as follows. The standard terminology for QNAM and QLABEL are listed below.

STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXRS2324-P0001RSSEQ4RSCBRFLConditionally Branched Item FlagYCRF
STUDYXRS2324-P0001RSTESTCDCBS0109RSANTXLOAnchor Text Lowno painCRF
STUDYXRS2324-P0001RSTESTCDCBS0109RSANTXHIAnchor Text Highworst pain possibleCRF
STUDYXRS2324-P0001RSTESTCDCBS0109RSANVLLOAnchor Value Low0CRF
STUDYXRS2324-P0001RSTESTCDCBS0109RSANVLHIAnchor Value High10CRF

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 RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.


RSTESTCD = "CBS0101" RSTEST = "CBS01-Alertness"

RSORRESRSSTRESCRSSTRESN
deeply asleep (eyes closed, no response to changes in the environment)11
lightly asleep (eyes mostly closed, occasional responses)22
drowsy (child closes his/her eyes frequently, less responsive to the environment)33
awake and alert (child responsive to the environment)44
awake and hyper-alert (exaggerated responses to environmental stimuli)55


RSTESTCD = "CBS0102" RSTEST = "CBS01-Calmness/Agitation"

RSORRESRSSTRESCRSSTRESN
calm (child appears serene and tranquil)11
slightly anxious (child shows slight anxiety)22
anxious (child appears agitated but remains in control)33
very anxious (child appears very agitated, just able to control)44
panicky (severe distress with loss of control)55


RSTESTCD = "CBS0103" RSTEST = "CBS01-Respiratory Response"

RSORRESRSSTRESCRSSTRESN
no spontaneous respiration11
spontaneous and ventilator respiration22
restlessness or resistance to ventilator33
actively breathes against ventilator or coughs regularly44
fights ventilator55


RSTESTCD = "CBS0104" RSTEST = "CBS01-Crying"

RSORRESRSSTRESCRSSTRESN
quiet breathing, no crying sounds11
occasional sobbing or moaning22
whining (monotonous sound)33
crying44
screaming or shrieking55


RSTESTCD = "CBS0105" RSTEST = "CBS01-Physical Movement"

RSORRESRSSTRESCRSSTRESN
no movement11
occasional, (three or fewer) slight movements22
frequent, (more than three) slight movements33
vigorous movements limited to extremities44
vigorous movements including torso and head55


RSTESTCD = "CBS0106" RSTEST = "CBS01-Muscle Tone"

RSORRESRSSTRESCRSSTRESN
muscles totally relaxed; no muscle tone11
reduced muscle tone; less resistance than normal22
normal muscle tone33
increased muscle tone and flexion of fingers and toes44
extreme muscle rigidity and flexion of fingers and toes55


RSTESTCD = "CBS0107" RSTEST = "CBS01-Facial Tension"

RSORRESRSSTRESCRSSTRESN
facial muscles totally relaxed11
normal facial tone22
tension evident in some facial muscles (not sustained)33
tension evident throughout facial muscles (sustained)44
facial muscles contorted and grimacing55


RSTESTCD = "CBS0110" RSTEST = "CBS01-NISS"

RSORRESRSSTRESCRSSTRESN
insufficient sedation11
adequate sedation22
oversedation33



5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for Clinical Classifications (SUPPRS) special purpose dataset.

QNAMQLABELQVAL
RSANTXLOAnchor Text Lowno pain
RSANTXHIAnchor Text Highworst pain possible
RSANVLLOAnchor Value Low0
RSANVLHIAnchor Value High10
RSCBRFLConditionally Branched Item FlagY


End of Document

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