Instructions on how to use this template
- 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.
- Unless otherwise noted, text in black applies to all QRS Supplements and should not be deleted
- Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
- 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.
- 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.
- ******ITEMS IN RED: Needs to be discussed with Steve/Dana.*******
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.
Revision History
| Date | Version | Summary of Changes |
|---|---|---|
| 2022-10-25 | 2.0 |
|
| 2015-02-18 | 1.0 | Initial 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:
- Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) First Administration Version (Copyright 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered including the standardized Dyspnea Domain (CRQSAS), Principal authors G.H. Guyatt and Dr. H.J. Schunemann, is the copyright of McMaster University (Copyright 2001, McMaster University).
- http://milo.mcmaster.ca/questionnaires/questionnaires
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2845220/
- http://www.proqolid.org/instruments/chronic_respiratory_disease_questionnaire_self_administered_standardized_crq_sas
- Schunemann HJ, Griffith L, Jaeschke R, Goldstein R, Stubbing D, Austin P, Guyatt GH. A comparison of the original chronic respiratory questionnaire with a standardized version. Chest. 2003 Oct;124(4):1421-9
.
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.
- 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.
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").
Records are created in qs.xpt for every item on the instrument:
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.
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the qualifier, timing, result, and 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 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." 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.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
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.
| QSSCAT | QSTESTCD |
|---|---|
| EMOTIONAL/INFORMATIONAL SUPPORT | QSSS0101 - QSSS0108 |
| TANGIBLE SUPPORT | QSSS0109 - QSSS0112 |
| AFFECTIONATE SUPPORT | QSSS0113 - QSSS0115 |
| POSITIVE SOCIAL INTERACTION | QSSS0116 - QSSS0118 |
| ADDITIONAL ITEM | QSSS0119 |
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"
| QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Original result 1 | 0 | 0 |
| Original result 2 | 1 | 1 |
| Original result 3 | 2 | 2 |
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"
| QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| I never take longer than 30 minutes to fall asleep | 0 | 0 |
| I take at least 30 minutes to fall asleep, less than half the time | 1 | 1 |
| I take at least 30 minutes to fall asleep, more than half the time | 2 | 2 |
| I take more than 60 minutes to fall asleep, more than half the time | 3 | 3 |
Omit the QSSTRESN column when it is not applicable to the dataset.
QSTESTCD = "test code" QSTEST = "test name"
| QSORRES | QSSTRESC |
|---|---|
| yes | Y |
| no | N |
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"
| QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| I have not experienced the physical sensation of feeling weighted down and without physical energy | 0 | 0 |
| I have occasionally experienced periods of feeling physically weighted down and without physical energy, but without a negative effect on work, school, or activity level | 1 | 1 |
| I feel physically weighted down (without physical energy) more than half the time | 2 | 2 |
| I feel physically weighted down (without physical energy) most of the time, several hours per day, several days per week | 3 | 3 |
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.
| QNAM | QLABEL | QVAL |
|---|---|---|
| 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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