Page History

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• 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).

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• 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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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 VERSION First Administration is a multiple -choice instrument choice patient reported outcome (PRO) assessment that clinicians may use to assess the severity of depressive symptoms. measure health-related quality of life (HRQL) in patients with chronic respiratory diseases.  It consists of 30 20 items , with each rated item graded on a 47-point Likert scale. A total score between 0-84 is also captured.

1. The scale points include a numeric rating (1-7) and a Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 1 = "I never take longer than 30 minutes to fall asleepAll 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. (replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”..  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. Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "QSEVLINT field in ISO 8601 format" and replace "the past 7 days" with the text (e.g., "DAYTIME'". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes. The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.: 

   If numeric use this wording:

   The time period of evaluation for theCRQ-SAS FIRST ADMINISTRATION VERSION is populated in the --EVLINTfield 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

   past 7 days (--EVLINT

   LAST 2 WEEKS (QSEVLINT = "-

   P7D

   P2W"). 

3. If text use this wording: The time period of evaluation for the CRQ-SAS FIRST ADMINISTRATION VERSION is populated in the --EVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the CRQ-SAS FIRST ADMINISTRATION VERSION is "LIFETIME" (--EVINTX = "LIFETIME").
4. If there are subcategories, include a note that subcategories will be represented in QSSCAT. Also provide a list of the subcategories unless one is already provided in the description preceding the assumptions. Remove this point if it does not apply.  For example:  Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".

5. 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 = "LOGICALLY SKIPPED ITEM" or QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

6. If the instrument standards currently being developed includes logically skipped items, insert:  Some items on the CRQ-SAS FIRST ADMINISTRATION VERSION may be logically skipped per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a logically skipped item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:

   1. RSSTAT = "NOT DONE".       

   2. RSREASND = "LOGICALLY SKIPPED ITEM".
      

   3. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).

7. Include this point if score(s) are submitted to SDTM. Update blue text: The CRQ-SAS FIRST ADMINISTRATION VERSION instrument includes a total score (and other scores as needed.  If so, change "that is" to "that are") that is considered as captured data on the CRF and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

   2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

8. This language is currently under review. Evaluator information is only to be included when the information is collected directly on the CRF. instruments will no longer be using QSEVAL/QSEVALID; however RSEVAL/RSEVALID and FTEVAL/FTEVALID will continue to be used on Clinical Classifications and Functional Tests. Language for Clinical Classifications and Functional tests follows; language for instruments is currently under review. Remove this point if it does not apply.

   For Clinical Classifications and Functional Tests (only when collected on the CRF):  *** This section to be updated.  QSEVAL/ID, FTEVAL/ID, and RSEVAL/ID will no longer be used.  Supplemental qualifiers will represent this information. *** For  CRQ-SAS FIRST ADMINISTRATION VERSION, the evaluator is defined as the (the appropriate term from controlled terminology). Alternatively, if only evaluator name or initials could be collected: For CRQ-SAS FIRST ADMINISTRATION VERSION, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. CDISC Controlled Terminology is available for Evaluator (e.g., --EVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID = "RATER 1"). To reiterate, only include this point if the evaluator/administrator is collected directly on the CRF.

9. Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the CRQ-SAS FIRST ADMINISTRATION VERSION will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

10. Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the CRQ-SAS FIRST ADMINISTRATION VERSION items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.
    

11. Terminology

    1. QSCAT, QSTESTCD, and QSTEST (and other variables such as QSORRESU as needed) 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. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

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. When there are numeric results, then use this sentence next, "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."

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Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

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When the reason is collected for a not done visit, information or a row description should be added as follows:

1. 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.

2. 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. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

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.

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