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- 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 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").
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.
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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.
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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. |
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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.
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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"
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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.
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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"
QSTESTCD = "CRQ0101" QSTEST = "CRQ01-Feeling Emotional"
QSTESTCD = "CRQ0102" QSTEST = "CRQ01-Take Care of Basic Needs"
QSTESTCD = "CRQ0103" QSTEST = "CRQ01-Walking"
QSTESTCD = "CRQ0104" QSTEST = "CRQ01-Performing Chores"
QSTESTCD = "CRQ0105" QSTEST = "CRQ01-Participate in Social Activities"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Extremely short of breath | 1 | 1 |
| Very short of breath | 2 | 2 |
| Quite a bit short of breath | 3 | 3 |
| Moderate shortness of breath | 4 | 4 |
| Some shortness of breath | 5 | 5 |
| A little shortness of breath | 6 | 6 |
| Not at all short of breath | 7 | 7 |
| Not Done | 8 | 8 |
QSTESTCD = "CRQ0106" QSTEST = "CRQ01-Felt Frustrated or Impatient"
QSTESTCD = "CRQ0107" QSTEST = "CRQ01-Feeling of Fear or Panic"
QSTESTCD = "CRQ0109" QSTEST = "CRQ01-Embarrassed by Coughing"
QSTESTCD = "CRQ0112" QSTEST = "CRQ01-Feel Upset, Worried or Depressed"
QSTESTCD = "CRQ0115" QSTEST = "CRQ01-Felt Low in Energy"
QSTESTCD = "CRQ0116" QSTEST = "CRQ01-Felt Discouraged or Down"
QSTESTCD = "CRQ0117" QSTEST = "CRQ01-Felt Worn Out or Sluggish"
QSTESTCD = "CRQ0119" QSTEST = "CRQ01-Feel Upset Diff Getting Breath"
QSTESTCD = "CRQ0120" QSTEST = "CRQ01-Felt Restless, Tense or Uptight"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| All of the time | 1 | 1 |
| Most of the time | 2 | 2 |
| A good bit of the time | 3 | 3 |
| Some of the time | 4 | 4 |
| A little of the time | 5 | 5 |
| Hardly any of the time | 6 | 6 |
| None of the time | 7 | 7 |
QSTESTCD = "CRQ0108" QSTEST = "CRQ01-Fatigue"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Extremely tired | 1 | 1 |
| Very tired | 2 | 2 |
| Quite a bit of tiredness | 3 | 3 |
| Moderately tired | 4 | 4 |
| Somewhat tired | 5 | 5 |
| A little tired | 6 | 6 |
| Not at all tired | 7 | 7 |
QSTESTCD = "CRQ0110" QSTEST = "CRQ01-Confident to Deal With Illness"
QSTESTCD = "CRQ0113" QSTEST = "CRQ01-Control of Breathing Problems"
QSTESTCD = "CRQ0114" QSTEST = "CRQ01-Feel Relaxed and Free of Tension"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| None of the time | 1 | 1 |
| A little of the time | 2 | 2 |
| Some of the time | 3 | 3 |
| A good bit of the time | 4 | 4 |
| Most of the time | 5 | 5 |
| Almost all of the time | 6 | 6 |
| All of the time | 7 | 7 |
QSTESTCD = "CRQ0111" QSTEST = "CRQ01-Energy"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| No energy at all | 1 | 1 |
| A little energy | 2 | 2 |
| Some energy | 3 | 3 |
| Moderately energetic | 4 | 4 |
| Quite a bit of energy | 5 | 5 |
| Very energetic | 6 | 6 |
| Full of energy | 7 | 7 |
QSTESTCD = "CRQ0118" QSTEST = "CRQ01-Happy, Satisfied or Pleased"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Very dissatisfied, unhappy most of the time | 1 | 1 |
| Generally dissatisfied, unhappy | 2 | 2 |
| Somewhat dissatisfied, unhappy | 3 | 3 |
| Generally satisfied, pleased | 4 | 4 |
| Happy most of the time | 5 | 5 |
| Very happy most of the time | 6 | 6 |
| Extremely happy, could not be more satisfied or pleased | 7 | 7 |
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Omit the QSSTRESN column when it is not applicable to the dataset.
QSTESTCD = "test code" QSTEST = "test name"
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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"
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5 Supplemental Qualifier Name Codes
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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.
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| Name | suppqs |
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End of Document
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