Revision History

© 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. 

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

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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, 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.

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.

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.

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