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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
Date2022-10-25
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
2022-10-252.0
  • 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.
  • 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

© 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 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 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 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 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 Dr. Gordon H. Guyatt Dept. of Clinical Epidemiology & Biostatistics, 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:

.


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 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 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, the sponsor’s analysis plan should determine whether this value is considered a score for purposes of summary statistic calculations.
  2. The time period of evaluation for the CRQ-SAS FIRST ADMINISTRATION VERSION is populated in the --EVLINT 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 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.

  4. Terminology

    1. QSCAT, QSTESTCD, and QSTEST 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.

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 1 subject 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." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument.


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
-P2W
22STUDYXQS2324-P000222CRQ0102CRQ01-Take Care of Basic NeedsCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
23STUDYXQS2324-P000223CRQ0103CRQ01-WalkingCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
24STUDYXQS2324-P000224CRQ0104CRQ01-Performing ChoresCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
25STUDYXQS2324-P000225CRQ0105CRQ01-Participate in Social ActivitiesCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
26STUDYXQS2324-P000226CRQ0106CRQ01-Felt Frustrated or ImpatientCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
27STUDYXQS2324-P000227CRQ0107CRQ01-Feeling of Fear or PanicCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
28STUDYXQS2324-P000228CRQ0108CRQ01-FatigueCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
29STUDYXQS2324-P000229CRQ0109CRQ01-Embarrassed by CoughingCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
30STUDYXQS2324-P000230CRQ0110CRQ01-Confident to Deal With IllnessCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
31STUDYXQS2324-P000231CRQ0111CRQ01-EnergyCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
32STUDYXQS2324-P000232CRQ0112CRQ01-Feel Upset, Worried or DepressedCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
33STUDYXQS2324-P000233CRQ0113CRQ01-Control of Breathing ProblemsCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
34STUDYXQS2324-P000234CRQ0114CRQ01-Feel Relaxed and Free of TensionCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
35STUDYXQS2324-P000235CRQ0115CRQ01-Felt Low in EnergyCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
36STUDYXQS2324-P000236CRQ0116CRQ01-Felt Discouraged or DownCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
37STUDYXQS2324-P000237CRQ0117CRQ01-Felt Worn Out or SluggishCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
38STUDYXQS2324-P000238CRQ0118CRQ01-Happy, Satisfied or PleasedCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
39STUDYXQS2324-P000239CRQ0119CRQ01-Feel Upset Diff Getting BreathCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
40STUDYXQS2324-P000240CRQ0120CRQ01-Felt Restless, Tense or UptightCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
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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.

Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

Some example mappings are below.

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 FIRST 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.

QSSCATQSTESTCD
EMOTIONAL/INFORMATIONAL SUPPORTQSSS0101 - QSSS0108
TANGIBLE SUPPORTQSSS0109 - QSSS0112
AFFECTIONATE SUPPORTQSSS0113 - QSSS0115
POSITIVE SOCIAL INTERACTIONQSSS0116 - QSSS0118
ADDITIONAL ITEMQSSS0119

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"

QSORRESQSSTRESCQSSTRESN
Original result 100
Original result 211
Original result 322

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"

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"

QSORRESQSSTRESCQSSTRESN
I never take longer than 30 minutes to fall asleep00
I take at least 30 minutes to fall asleep, less than half the time11
I take at least 30 minutes to fall asleep, more than half the time22
I take more than 60 minutes to fall asleep, more than half the time33

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

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

QSORRESQSSTRESC
yesY
noN

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"

QSORRESQSSTRESCQSSTRESN
I have not experienced the physical sensation of feeling weighted down and without physical energy00
I have occasionally experienced periods of feeling physically weighted down and without physical energy, but without a negative effect on work, school, or activity level11
I feel physically weighted down (without physical energy) more than half the time22
I feel physically weighted down (without physical energy) most of the time, several hours per day, several days per week33


5 Supplemental Qualifier Name Codes

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.

Remove Section 5 if it does not apply to the new instrument.

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

QNAMQLABELQVAL
Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)Value of QNAM ( e.g., SUBJECT VISIT)


End of Document

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