You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 31 Next »

Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Chronic Respiratory Questionnaire - Self-Administered Standardized Format First Administration Version (CRQ-SAS FIRST ADMINISTRATION VERSION)

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

CRQ-SAS FIRST ADMINISTRATION VERSION

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusREVISION DRAFT
Date2023-04-13
Notes
  • 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.


Revision History

DateVersionSummary of Changes
2023-03-232.0
  • Converted the supplement to the current WIKI QRS supplement template.
  • Annotated CRF updated to the MSG V2.0 annotation guidelines
  • Copyright Status section was updated based on the latest Memorandum of Understanding signed between McMaster
    University and CDISC.
  • Reference for the CRQ-SAS FIRST ADMINISTRATION VERSION was updated to retain only the valid hyperlinks.
  • Updated the assumption to clarify that the CRQ-SAS First Administration consists of 20 items with each item graded on a 7-point or 8-point Likert scale.
  • Updated assumption 1.a to specify users need to follow the scoring solution in their approved copyright permission when the result is“8 = Not Done”.
  • Removed the QSEVAL assumption and variables as this is not captured on the CRF and no assumptions are made on potential values.
  • The “QSBLFL” variable was replaced with the “QSLOBXFL” variable in the example to represent a baseline response for visit 1.
  • An additional subject was added to the data example to show how missing data is handled when the instrument was not completed.
2015-02-181.0Initial Final Version

© 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 First 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 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 FIRST 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. 

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 Gay Yuyitung, Executive Director, McMaster University, Hamilton, Ontario, Canada for the approval to include the CRQ-SAS FIRST ADMINISTRATION VERSION in the CDISC data standards.

Reference for the CRQ-SAS FIRST ADMINISTRATION VERSION:

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 FIRST ADMINISTRATION VERSION are listed below.

The CRQ-SAS First Administration is a multiple choice patient reported outcome (PRO) assessment 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 FIRST 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.
  2. The time period of evaluation for the CRQ-SAS FIRST ADMINISTRATION VERSION is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the CRQ-SAS FIRST ADMINISTRATION VERSION is the LAST 2 WEEKS (QSEVLINT = "-P2W")

  3. 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.
  4. 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 FIRST ADMINISTRATION VERSION QS Domain Model

The CRQ-SAS FIRST ADMINISTRATION VERSION example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 2 subjects collected at the baseline visit for the CRQ-SAS FIRST ADMINISTRATION VERSION instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCATAll 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.


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 CRQ-SAS FIRST ADMINISTRATION VERSION instrument. Subject 2324-P0002 was not evaluated on this instrument. 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.

qs.xpt

qs.xpt

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011CRQ0101CRQ01-Feeling EmotionalCRQ-SAS FIRST ADMINISTRATION VERSIONExtremely short of breath11
Y12022-05-15-P2W
2STUDYXQS2324-P00012CRQ0102CRQ01-Take Care of Basic NeedsCRQ-SAS FIRST ADMINISTRATION VERSIONVery short of breath22
Y12022-05-15-P2W
3STUDYXQS2324-P00013CRQ0103CRQ01-WalkingCRQ-SAS FIRST ADMINISTRATION VERSIONModerate shortness of breath44
Y12022-05-15-P2W
4STUDYXQS2324-P00014CRQ0104CRQ01-Performing ChoresCRQ-SAS FIRST ADMINISTRATION VERSIONNot at all short of breath77
Y12022-05-15-P2W
5STUDYXQS2324-P00015CRQ0105CRQ01-Participate in Social ActivitiesCRQ-SAS FIRST ADMINISTRATION VERSIONNot Done88
Y12022-05-15-P2W
6STUDYXQS2324-P00016CRQ0106CRQ01-Felt Frustrated or ImpatientCRQ-SAS FIRST ADMINISTRATION VERSIONA good bit of the time33
Y12022-05-15-P2W
7STUDYXQS2324-P00017CRQ0107CRQ01-Feeling of Fear or PanicCRQ-SAS FIRST ADMINISTRATION VERSIONSome of the time44
Y12022-05-15-P2W
8STUDYXQS2324-P00018CRQ0108CRQ01-FatigueCRQ-SAS FIRST ADMINISTRATION VERSIONExtremely tired11
Y12022-05-15-P2W
9STUDYXQS2324-P00019CRQ0109CRQ01-Embarrassed by CoughingCRQ-SAS FIRST ADMINISTRATION VERSIONA little of the time55
Y12022-05-15-P2W
10STUDYXQS2324-P000110CRQ0110CRQ01-Confident to Deal With IllnessCRQ-SAS FIRST ADMINISTRATION VERSIONA little of the time22
Y12022-05-15-P2W
11STUDYXQS2324-P000111CRQ0111CRQ01-EnergyCRQ-SAS FIRST ADMINISTRATION VERSIONFull of energy77
Y12022-05-15-P2W
12STUDYXQS2324-P000112CRQ0112CRQ01-Feel Upset, Worried or DepressedCRQ-SAS FIRST ADMINISTRATION VERSIONHardly any of the time66
Y12022-05-15-P2W
13STUDYXQS2324-P000113CRQ0113CRQ01-Control of Breathing ProblemsCRQ-SAS FIRST ADMINISTRATION VERSIONMost of the time55
Y12022-05-15-P2W
14STUDYXQS2324-P000114CRQ0114CRQ01-Feel Relaxed and Free of TensionCRQ-SAS FIRST ADMINISTRATION VERSIONA good bit of the time44
Y12022-05-15-P2W
15STUDYXQS2324-P000115CRQ0115CRQ01-Felt Low in EnergyCRQ-SAS FIRST ADMINISTRATION VERSIONA good bit of the time33
Y12022-05-15-P2W
16STUDYXQS2324-P000116CRQ0116CRQ01-Felt Discouraged or DownCRQ-SAS FIRST ADMINISTRATION VERSIONMost of the time22
Y12022-05-15-P2W
17STUDYXQS2324-P000117CRQ0117CRQ01-Felt Worn Out or SluggishCRQ-SAS FIRST ADMINISTRATION VERSIONAll of the time11
Y12022-05-15-P2W
18STUDYXQS2324-P000118CRQ0118CRQ01-Happy, Satisfied or PleasedCRQ-SAS FIRST ADMINISTRATION VERSIONHappy most of the time55
Y12022-05-15-P2W
19STUDYXQS2324-P000119CRQ0119CRQ01-Feel Upset Diff Getting BreathCRQ-SAS FIRST ADMINISTRATION VERSIONMost of the time22
Y12022-05-15-P2W
20STUDYXQS2324-P000120CRQ0120CRQ01-Felt Restless, Tense or UptightCRQ-SAS FIRST ADMINISTRATION VERSIONSome of the time44
Y12022-05-15-P2W
21STUDYXQS2324-P000221CRQ0101CRQ01-Feeling EmotionalCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

22STUDYXQS2324-P000222CRQ0102CRQ01-Take Care of Basic NeedsCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

23STUDYXQS2324-P000223CRQ0103CRQ01-WalkingCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

24STUDYXQS2324-P000224CRQ0104CRQ01-Performing ChoresCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

25STUDYXQS2324-P000225CRQ0105CRQ01-Participate in Social ActivitiesCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

26STUDYXQS2324-P000226CRQ0106CRQ01-Felt Frustrated or ImpatientCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

27STUDYXQS2324-P000227CRQ0107CRQ01-Feeling of Fear or PanicCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

28STUDYXQS2324-P000228CRQ0108CRQ01-FatigueCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

29STUDYXQS2324-P000229CRQ0109CRQ01-Embarrassed by CoughingCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

30STUDYXQS2324-P000230CRQ0110CRQ01-Confident to Deal With IllnessCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

31STUDYXQS2324-P000231CRQ0111CRQ01-EnergyCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

32STUDYXQS2324-P000232CRQ0112CRQ01-Feel Upset, Worried or DepressedCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

33STUDYXQS2324-P000233CRQ0113CRQ01-Control of Breathing ProblemsCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

34STUDYXQS2324-P000234CRQ0114CRQ01-Feel Relaxed and Free of TensionCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

35STUDYXQS2324-P000235CRQ0115CRQ01-Felt Low in EnergyCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

36STUDYXQS2324-P000236CRQ0116CRQ01-Felt Discouraged or DownCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

37STUDYXQS2324-P000237CRQ0117CRQ01-Felt Worn Out or SluggishCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

38STUDYXQS2324-P000238CRQ0118CRQ01-Happy, Satisfied or PleasedCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

39STUDYXQS2324-P000239CRQ0119CRQ01-Feel Upset Diff Getting BreathCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

40STUDYXQS2324-P000240CRQ0120CRQ01-Felt Restless, Tense or UptightCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1

$warningHtml

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 = "CRQ0101" QSTEST = "CRQ01-Feeling Emotional"

QSTESTCD = "CRQ0102" QSTEST = "CRQ01-Take Care of Basic Needs"

QSTESTCD = "CRQ0103" QSTEST = "CRQ01-Walking"

QSTESTCD = "CRQ0104" QSTEST = "CRQ01-Performing Chores"

QSTESTCD = "CRQ0105" QSTEST = "CRQ01-Participate in Social Activities"

QSORRES

QSSTRESC

QSSTRESN

Extremely short of breath11
Very short of breath22
Quite a bit short of breath33
Moderate shortness of breath44
Some shortness of breath55
A little shortness of breath66
Not at all short of breath77
Not Done88

QSTESTCD = "CRQ0106" QSTEST = "CRQ01-Felt Frustrated or Impatient"

QSTESTCD = "CRQ0107" QSTEST = "CRQ01-Feeling of Fear or Panic"

QSTESTCD = "CRQ0109" QSTEST = "CRQ01-Embarrassed by Coughing"

QSTESTCD = "CRQ0112" QSTEST = "CRQ01-Feel Upset, Worried or Depressed"

QSTESTCD = "CRQ0115" QSTEST = "CRQ01-Felt Low in Energy"

QSTESTCD = "CRQ0116" QSTEST = "CRQ01-Felt Discouraged or Down"

QSTESTCD = "CRQ0117" QSTEST = "CRQ01-Felt Worn Out or Sluggish"

QSTESTCD = "CRQ0119" QSTEST = "CRQ01-Feel Upset Diff Getting Breath"

QSTESTCD = "CRQ0120" QSTEST = "CRQ01-Felt Restless, Tense or Uptight"

QSORRES

QSSTRESC

QSSTRESN

All of the time11
Most of the time22
A good bit of the time33
Some of the time44
A little of the time55
Hardly any of the time66
None of the time77

QSTESTCD = "CRQ0108" QSTEST = "CRQ01-Fatigue"

QSORRES

QSSTRESC

QSSTRESN

Extremely tired11
Very tired22
Quite a bit of tiredness33
Moderately tired44
Somewhat tired55
A little tired66
Not at all tired77

QSTESTCD = "CRQ0110" QSTEST = "CRQ01-Confident to Deal With Illness"

QSTESTCD = "CRQ0113" QSTEST = "CRQ01-Control of Breathing Problems"

QSTESTCD = "CRQ0114" QSTEST = "CRQ01-Feel Relaxed and Free of Tension"

QSORRES

QSSTRESC

QSSTRESN

None of the time11
A little of the time22
Some of the time33
A good bit of the time44
Most of the time55
Almost all of the time66
All of the time77

QSTESTCD = "CRQ0111" QSTEST = "CRQ01-Energy"

QSORRES

QSSTRESC

QSSTRESN

No energy at all11
A little energy22
Some energy33
Moderately energetic44
Quite a bit of energy55
Very energetic66
Full of energy77

QSTESTCD = "CRQ0118" QSTEST = "CRQ01-Happy, Satisfied or Pleased"

QSORRES

QSSTRESC

QSSTRESN

Very dissatisfied, unhappy most of the time11
Generally dissatisfied, unhappy22
Somewhat dissatisfied, unhappy33
Generally satisfied, pleased44
Happy most of the time55
Very happy most of the time66
Extremely happy, could not be more satisfied or pleased77


End of Document

  • No labels