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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 C-SSRS BASELINE 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. | QSSCAT | QSTESTCD |
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| EMOTIONAL/INFORMATIONAL SUPPORT | QSSS0101 - QSSS0108 | | TANGIBLE SUPPORT | QSSS0109 - QSSS0112 |
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| | AFFECTIONATE SUPPORT | QSSS0113 - QSSS0115 | | POSITIVE SOCIAL INTERACTION | QSSS0116 - QSSS0118 | | ADDITIONAL ITEM | QSSS0119 |
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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"
| QSORRES | QSSTRESC | QSSTRESN |
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| Original result 1 | 0 | 0 |
| Original result 2 | 1 | 1 |
| Original result 3 | 2 | 2 |
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"
| QSORRES | QSSTRESC | QSSTRESN |
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| I never take longer than 30 minutes to fall asleep | 0 | 0 |
| I take at least 30 minutes to fall asleep, less than half the time | 1 | 1 |
| I take at least 30 minutes to fall asleep, more than half the time | 2 | 2 |
| I take more than 60 minutes to fall asleep, more than half the time | 3 | 3 |
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Omit the QSSTRESN column when it is not applicable to the dataset.
QSTESTCD = "test code" QSTEST = "test name"
| QSORRES | QSSTRESC |
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| yes | Y |
| no | N |
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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" | QSORRES | QSSTRESC | QSSTRESN |
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| I have not experienced the physical sensation of feeling weighted down and without physical energy | 0 | 0 | | I have occasionally experienced periods of feeling physically weighted down and without physical energy, but without a negative effect on work, school, or activity level | 1 | 1 | | I feel physically weighted down (without physical energy) more than half the time | 2 | 2 | | I feel physically weighted down (without physical energy) most of the time, several hours per day, several days per week | 3 | 3 |
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5 Supplemental Qualifier Name Codes
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