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The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is a multiple-choice instrument 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 or 8-point Likert scale. A total score between 0-84 is also captured.

  1. The scale points include a numeric rating (1-7) and a definition of what 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 CRQthe CRQ-SAS FOLLOW-UP 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”.
           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. 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 the

    The time period of evaluation for theCRQ-SAS FOLLOW-UP 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 FOLLOW-UP 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 FOLLOW-UP ADMINISTRATION VERSION is the past 7 days (QSEVLINT = "-P7D"). 
  3. If text use this wording: The time period of evaluation for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is populated in the QSEVINTX 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 FOLLOW-UP ADMINISTRATION VERSION is "LIFETIME" (QSEVINTX = "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 = "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 FOLLOW-UP 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 FOLLOW-UP 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 QSDRVFL 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 (QSDRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and QSDRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables). Subtotal and total scores are represented in QSORRES.

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

  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 FOLLOW-UP 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 FOLLOW-UP 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., QSEVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., QSEVALID = "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 FOLLOW-UP ADMINISTRATION VERSION will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

  10. the LAST 2 WEEKS (QSEVLINT = "-P2W").

  11. 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

    Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the CRQ-SAS FOLLOW-UP 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

    1. .

  12. Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN (and other variables such as QSORRESU as needed; only include QSORRES, QSSTRESC, and QSSTRESN if the responses are published in CT with public domains instruments) values 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 FOLLOW-UP ADMINISTRATION VERSION QS Domain Model

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