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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 RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) 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 QRS Short_Name 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"
RSTESTCD = "CBS0101" RSTEST = "CBS01-Alertness"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| deeply asleep (eyes closed, no response to changes in the environment) | 1 | 1 |
| lightlylightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
| drowsy (child closes his/her eyes frequently, less responsive to the environment) | 3 | 3 |
| awake and alert (child responsive to the environment) | 4 | 4 |
| awake and hyper-alert (exaggerated responses to environmental stimuli) | 5 | 5 |
RSTESTCD = "CBS0102" RSTEST = "CBS01-Calmness/Agitation"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| calm (child appears serene and tranquil) | 1 | 1 |
| slightly anxious (child shows slight anxiety) | 2 | 2 |
| anxious (child appears agitated but remains in control) | 3 | 3 |
| very anxious (child appears very agitated, just able to control) | 4 | 4 |
| panicky (severe distress with loss of control) | 5 | 5 |
RSTESTCD = "CBS0103" RSTEST = "CBS01-Respiratory Response"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| no spontaneous respiration | 1 | 1 |
| spontaneous and ventilator respiration | 2 | 2 |
| restlessness or resistance to ventilator | 3 | 3 |
| actively breathes against ventilator or coughs regularly | 4 | 4 |
| fights ventilator | 5 | 5 |
RSTESTCD = "CBS0104" RSTEST = "CBS01-Crying"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| quiet breathing, no crying sounds | 1 | 1 |
| occasional sobbing or moaning | 2 | 2 |
| whining (monotonous sound) | 3 | 3 |
| crying | 4 | 4 |
| screaming or shrieking | 5 | 5 |
RSTESTCD = "CBS0105" RSTEST = "CBS01-Physical Movement"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| no movement | 1 | 1 |
| occasional, (three or fewer) slight movements | 2 | 2 |
| frequent, (more than three) slight movements | 3 | 3 |
| vigorous movements limited to extremities | 4 | 4 |
| vigorous movements including torso and head | 5 | 5 |
RSTESTCD = "CBS0106" RSTEST = "CBS01-Muscle Tone"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| muscles totally relaxed; no muscle tone | 1 | 1 |
| reduced muscle tone; less resistance than normal | 2 | 2 |
| normal muscle tone | 3 | 3 |
| increased muscle tone and flexion of fingers and toes | 4 | 4 |
| extreme muscle rigidity and flexion of fingers and toes | 5 | 5 |
RSTESTCD = "CBS0107" RSTEST = "CBS01-Facial Tension"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| facial muscles totally relaxed | 1 | 1 |
| normal facial tone | 2 | 2 |
| tension evident in some facial muscles (not sustained) | 3 | 3 |
| tension evident throughout facial muscles (sustained) | 4 | 4 |
| facial muscles contorted and grimacing | 5 | 5 |
RSTESTCD = "CBS0109" RSTEST = "CBS01-NRS Pain"
RSTESTCD = "CBS0110" RSTEST = "CBS01-NISS"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| insufficient sedation | 1 | 1 |
| adequate sedation | 2 | 2 |
| oversedation | 3 | 3 |
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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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Omit the QSSTRESN column when it is not applicable to the dataset. QSTESTCD = "test code" QSTEST = "test name"
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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"
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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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