• 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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Revision History

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

1 Introduction

This document describes the CDISC implementation of the Chronic Respiratory Questionnaire - Self-Administered Standardized Format Follow-up Administration Version

...

 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

...

...

• This supplement is intended 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.

(SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These 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 protocols. CDISC disclaims any liability for your use of this material.

2 Copyright Status

McMaster University owns the copyright for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. McMaster University will distribute the CDISC supplement package to sponsors when they are approved to use this instrument. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

The “Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS)”, authored by Drs. Gordon Guyatt and Holger Schünemann, was made under license from McMaster University, Hamilton, Canada (Copyright ©2001, McMaster University). The CRQ-SAS is provided under license from McMaster University and may not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster Industry Liaison Office at: milo@mcmaster.ca for licensing details

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.

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 Gay Yuyitung, Executive Director, McMaster University, Hamilton, Ontario, Canada for the approval to include

Revision History

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• Converted the supplement to the current WIKI QRS supplement template.
• Annotated CRF updated to the MSG V2.0 annotation guidelines
• Removed the QSEVAL assumption and variables as this is not captured on the CRF and no assumptions are made on potential values.

...

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Chronic Respiratory Questionnaire - Self-Administered Standardized Format Follow-up Administration Version 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) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These 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.

2 Copyright Status

McMaster University owns the copyright for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. McMaster University will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

The “Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS)”, authored by Drs. Gordon Guyatt and Holger Schünemann, was made under license from McMaster University, Hamilton, Canada (Copyright ©2001, McMaster University). The CRQ-SAS is provided under license from McMaster University and may not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster Industry Liaison Office at: milo@mcmaster.ca for licensing details

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.

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.

...

.

Reference for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION:

• The Chronic Respiratory Questionnaire Self-Administered including the standardized Dyspnea Domain (CRQSAS), Principal authors G.H. Guyatt and Dr. H.J. Schunemann
• http://milo.mcmaster.ca/questionnaires/questionnaires
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2845220/

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION are listed below.

The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is a multiple-choice instrument that clinicians may use to measure health-related quality of life (HRQL) in patients with chronic respiratory diseases.  It consists of 20 items with each item graded on a 7-point or 8-point Likert scale.

1. The scale points include a numeric rating (1-7) and a definition of what is represented by the rating (e.g., 1 = "All of the time"). For the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION

...

1. , QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
          a.  The first 5 questions have a questionnaire choice of “8 = Not Done”. The result of “8” is included in QSSTRESC and QSSTRESN; however, users need to follow the scoring Solution in their approved copyright permission.

2. The time period of evaluation

...

1. for theCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION

...

• The Chronic Respiratory Questionnaire Self-Administered including the standardized Dyspnea Domain (CRQSAS), Principal authors G.H. Guyatt and Dr. H.J. Schunemann
• http://milo.mcmaster.ca/questionnaires/questionnaires
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2845220/

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION are listed below.

The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is a multiple-choice instrument that clinicians may use to measure health-related quality of life (HRQL) in patients with chronic respiratory diseases.  It consists of 20 items with each item graded on a 7-point or 8-point Likert scale.

...

The scale points include a numeric rating (1-7) and a definition of what is represented by the rating (e.g., 1 = "All of the time"). For the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
       a.  The first 5 questions have a questionnaire choice of “8 = Not Done”. The result of “8” is included in QSSTRESC and QSSTRESN; however, users need to follow the scoring Solution in their approved copyright permission.

1.  is populated in the QSEVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is the LAST 2 WEEKS (QSEVLINT = "-P2W").

2. Records are created in qs.xpt for every collected item on the instrument: 

   1. 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.

   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.

3. Terminology

   1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN 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 CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION QS Domain Model

The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at visit 3 and visit 4 for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

...

The table represents the items from the

CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION

...

Records are created in qs.xpt for every item on the instrument: 

...

instrument. Rows 21-40 show the subject was not evaluated on this instrument at visit 4. A record for each item on the instrument is created with a status of "NOT DONE".

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Terminology

1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN 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.

Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. 

3.2 Example for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION QS Domain Model

The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at visit 3 and visit 4 for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

...

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 QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

...

For QRS instruments with subcategories:

When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

...

...

If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

...

Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

...

If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 1" QSTEST = "test name 1"

QSTESTCD = "test code 4" QSTEST = "test name 4"

QSTESTCD = "test code 5" QSTEST = "test name 5"

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 QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

QSTESTCD = "CRQ0201" QSTEST = "CRQ02-Feeling Emotional"

QSTESTCD = "CRQ0202" QSTEST = "CRQ02-Take Care of Basic Needs"

QSTESTCD = "CRQ0203" QSTEST = "CRQ02-Walking"

QSTESTCD = "CRQ0204" QSTEST = "CRQ02-Performing Chores"

QSTESTCD = "CRQ0205" QSTEST = "CRQ02-Participate in Social Activities"

QSTESTCD = "CRQ0206" QSTEST = "CRQ02-Felt Frustrated or Impatient"

QSTESTCD = "CRQ0207" QSTEST = "CRQ02-Feeling of Fear or Panic"

QSTESTCD = "CRQ0209" QSTEST = "CRQ02-Embarrassed by Coughing"

QSTESTCD = "CRQ0212" QSTEST = "CRQ02-Feel Upset, Worried or Depressed"

QSTESTCD = "CRQ0215" QSTEST = "CRQ02-Felt Low in Energy"

QSTESTCD = "CRQ0216" QSTEST = "CRQ02-Felt Discouraged or Down"

QSTESTCD = "CRQ0217" QSTEST = "CRQ02-Felt Worn Out or Sluggish"

QSTESTCD = "CRQ0219" QSTEST = "CRQ02-Feel Upset Diff Getting Breath"

QSTESTCD = "CRQ0220" QSTEST = "CRQ02-Felt Restless, Tense or Uptight"

QSTESTCD = "CRQ0208" QSTEST = "CRQ02-Fatigue"

QSTESTCD = "CRQ0210" QSTEST = "CRQ02-Confident to Deal With Illness"

QSTESTCD = "CRQ0213" QSTEST = "CRQ02-Control of Breathing Problems"

QSTESTCD = "CRQ0214" QSTEST = "CRQ02-Feel Relaxed and Free of Tension"

QSTESTCD = "CRQ0211" QSTEST = "CRQ02-Energy"

QSTESTCD = "CRQ0218" QSTEST = "CRQ02-Happy, Satisfied or Pleased"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"

QSTESTCD = "test code 27" QSTEST = "test name 27"

QSTESTCD = "test code 29" QSTEST = "test name 29"

...

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

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

...

...

For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

...

5 Supplemental Qualifier Name Codes

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

...

...

End of Document