Versions Compared

Old Version 29

changes.mady.by.user Unknown User (ljoshua1)

Saved on

compared with

New Version 30

changes.mady.by.user Unknown User (ljoshua1)

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

m

Info
titleInstructions on how to use this template
  1. ******ITEMS IN RED: Needs to be discussed with Team.*******
Info
titleInformation 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.

Page properties
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
Date2023-0304-2313
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 ChangesChanges
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”.
2023-03-232.0
  • 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

...

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. 

Info
titleInformation 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.

...

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.
            aa.  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 solution in their approved copyright permission.

  2. The time period of evaluation for theCRQ-SAS FIRST ADMINISTRATION VERSION 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 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, 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.

...