• 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.

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• 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

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

1 Introduction

This document describes the CDISC implementation of the Comfort Behavior Scale (COMFORT-B 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 orimplement protocols. CDISC disclaims any liability for your use of this material.

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. 

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:

Revision History

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© 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/foundationalterminology/sdtmigcontrolled-terminology.

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.

...

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

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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.

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-B SCALE are listed below.

The COMFORT-B SCALE is a multiple-choice instrument that clinicians may use in 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; 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 to the NRS, the level of sedation (NISS="Nurse Interpretation of Sedation Score") is categorized as 1 = "insufficient sedation", 2 = "adequate sedation", 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. Either Respiratory Ventilation or Crying (RSTESTCD = "CBS0103" or "CBS0104") is completed for each subject.

   Jira
   showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-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 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.

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 RSCAT. All 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.

The table represents the items from the COMFORT-B SCALE 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. 

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.

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.

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.

...

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.

...

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.

...

Include this point if score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes a total score (and subscores or other scores as needed.  If so, change "that is" to "that are") 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 repsonsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.

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The SUPPQUAL variables used are a series of non-standard variables that represent collected administrator information, administration device, etc., and these updated SUPPQUAL variables are included in the WIKI non-standard variable registry (Non-standard Variable Registry). For example:

1. PPRAID which is "Preprinted Administrator Identifier".
2. COLAVL which is "Collected Administrator Value".

The supplement version 1.0 of the FAS-NACC UDS V3.0 instrument shows an implementation example.

The QRS Short_Name instrument collects administrative information as the preprinted examiner’s initials and the collected response. This is represented in the SUPPQUAL variable QNAM = --PPRAID” with QNAM = “Preprinted Administrator Identifier” and QVAL = “EXAMINER’S INITIALS”. The collected initials response is represented with QNAM = “--COLAID” and QNAM = “Collected Administrator Identifier” and QVAL = “ADM1”.

This is part of the data example for the SUPPQUAL variables.

The SUPPRS table represents the preprinted and collected administrative items represented on the CRF. 

 supprs.xpt

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Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the QRS Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

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Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the QRS Short_Name items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.

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Terminology

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

2. 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.)

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 RSCAT. All 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.

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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:

...

When the reason is collected for a not done visit, information or a row description should be added as follows:

...

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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.

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"

...

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

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

...

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

RSTESTCD = "CBS0104CBS0102" RSTEST = "CBS01-CryingCalmness/Agitation"

RSTESTCD = "CBS0105CBS0103" RSTEST = "CBS01-Physical MovementRespiratory Response"

RSTESTCD = "CBS0106CBS0104" RSTEST = "CBS01-Muscle ToneCrying"

RSTESTCD = "CBS0107CBS0105" RSTEST = "CBS01-Facial TensionPhysical Movement"

RSTESTCD = "CBS0109CBS0106" RSTEST = "CBS01-NRS PainMuscle Tone"

RSTESTCD = "CBS0110CBS0107" RSTEST = "CBS01-NISSFacial Tension"

...

Omit the QSSTRESN column when it is not applicable to the dataset.

QSTESTCD = "test code" QSTEST = "test name"

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5 Supplemental Qualifier Name Codes

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The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

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

5 Supplemental Qualifier Name Codes

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