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| Rows 13-14: | Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX". | | Rows 15-16: | Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX". | | Row 33: | The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF. | |
| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSSTAT | RSREASND | RSMETHOD | RSLOBXFL | RSREPNUM | VISITNUM | RSDTC |
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| 1 | STUDYX | RS | 2324-P0001 | 1 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightlylightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | | 2 | STUDYX | RS | 2324-P0001 | 2 | CBS0102 | CBS01-Calmness/Agitation | COMFORT-B SCALE | slightly anxious (child shows slight anxiety) | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | | 3 | STUDYX | RS | 2324-P0001 | 3 | CBS0103 | CBS01-Respiratory Response | COMFORT-B SCALE | no spontaneous respiration | 1 | 1 |
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| Y | 1 | 1 | 2023-05-15 | | 4 | STUDYX | RS | 2324-P0001 | 4 | CBS0104 | CBS01-Crying | COMFORT-B SCALE |
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| Y | 1 | 1 | 2023-05-15 | | 5 | STUDYX | RS | 2324-P0001 | 5 | CBS0105 | CBS01-Physical Movement | COMFORT-B SCALE | occasional, (three or fewer) slight movements | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | | 6 | STUDYX | RS | 2324-P0001 | 6 | CBS0106 | CBS01-Muscle Tone | COMFORT-B SCALE | normal muscle tone | 3 | 3 |
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| Y | 1 | 1 | 2023-05-15 | | 7 | STUDYX | RS | 2324-P0001 | 7 | CBS0107 | CBS01-Facial Tension | COMFORT-B SCALE | normal facial tone | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | | 8 | STUDYX | RS | 2324-P0001 | 8 | CBS0108 | CBS01-Total Score | COMFORT-B SCALE | 12 | 12 | 12 |
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| Y | 1 | 1 | 2023-05-15 | | 9 | STUDYX | RS | 2324-P0001 | 9 | CBS0109 | CBS01-NRS Pain | COMFORT-B SCALE | 5 | 5 | 5 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 1 | 2023-05-15 | 10 | STUDYX | RS | 2324-P0001 | 10 | CBS0110 | CBS01-NISS | COMFORT-B SCALE | 2 | 2 | 2 |
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| Y | 1 | 1 | 2023-05-15 | 11 | STUDYX | RS | 2324-P0001 | 11 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE | Midazolam | Midazolam |
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| Y | 1 | 1 | 2023-05-15 | 12 | STUDYX | RS | 2324-P0001 | 12 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
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| Y | 1 | 1 | 2023-05-15 | 13 | STUDYX | RS | 2324-P0001 | 1 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | 14 | STUDYX | RS | 2324-P0001 | 2 | CBS0102 | CBS01-Calmness/Agitation | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | 15 | STUDYX | RS | 2324-P0001 | 3 | CBS0103 | CBS01-Respiratory Response | COMFORT-B SCALE |
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| RSNOT DONE |
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| 41 | 2 | 2023-05-22 | 16 | STUDYX | RS | 2324-P0001 | 4 | CBS0104 | CBS0104 | CBS01-Crying | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | 17 | STUDYX | RS | 2324-P0001 | 5 | CBS0105 | CBS01-Physical Movement | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | 18 | STUDYX | RS | 2324-P0001 | 6 | CBS0106 | CBS01-Muscle Tone | COMFORT-B SCALE |
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| RSNOT DONE |
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| 71 | CBS01072 | 2023-05-22 | 19 | STUDYX | RS | 2324-P0001 | 7 | CBS0107 | CBS01-Facial Tension | CBS01-Facial Tension | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | 20 | STUDYX | RS | 2324-P0001 | 8 | CBS0108 | CBS01-Total Score | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | 21 | STUDYX | RS | 2324-P0001 | 9 | CBS0109 | CBS01-NRS Pain | COMFORT-B SCALE |
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| RSNOT DONE |
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| 101 | CBS01102 | CBS012023-05-NISS22 | 22 | STUDYX | RS | 2324-P0001 | 10 | CBS0110 | CBS01-NISS | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | 23 | STUDYX | RS | 2324-P0001 | COMFORT-B SCALE | RS | 11 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | 24 | STUDYX | RS | 2324-P0001 | 12 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 | 2023-05-22 | | Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.) |
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| | 33 | STUDYX | QS | 2324-P0001 | 33 | IDSR131 | IDSR1-Score | IDS-SR | 18 | 18 | 18 |
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| Y |
| 1 | 2015-05-15 |
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| Info |
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The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes): Text that would remain unchanged has been left in black: The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.
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| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| STUDYX | QSRS | 2324-P0001 | QSSEQ | Sequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8) | Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT). | Label for QNAM (e.g., Contact Type) | Value of QNAM variable ( e.g., SUBJECT VISIT) | CRF |
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4 SDTM Mapping Strategy
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.
RSTESTCD = "CBS0101" RSTEST = "CBS01-Alertness"
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RSTESTCD = "CBS0102" RSTEST = "CBS01-Calmness/Agitation"
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| RSSEQ | 4 | RSCBRFL | Conditionally Branched Item Flag | Y | CRF | | STUDYX | RS | 2324-P0001 | RSTESTCD | CBS0109 | RSANTXLO | Anchor Text Low | no pain | CRF | | STUDYX | RS | 2324-P0001 | RSTESTCD | CBS0109 | RSANTXHI | Anchor Text High | worst pain possible | CRF | | STUDYX | RS | 2324-P0001 | RSTESTCD | CBS0109 | RSANVLLO | Anchor Value Low | 0 | CRF | | STUDYX | RS | 2324-P0001 | RSTESTCD | CBS0109 | RSANVLHI | Anchor Value High | 10 | CRF |
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4 SDTM Mapping Strategy
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.
RSTESTCD = "CBS0101" RSTEST = "CBS01-AlertnessRSTESTCD = "CBS0103" RSTEST = "CBS01-Respiratory Response"
no spontaneous respiration| deeply asleep (eyes closed, no response to changes in the environment) | 1 | 1 |
spontaneous and ventilator respiration| lightlylightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
| restlessness or resistance to ventilator | 3 | 3 |
actively breathes against ventilator or coughs regularly| drowsy (child closes his/her eyes frequently, less responsive to the environment) | 3 | 3 |
| awake and alert (child responsive to the environment) | 4 | 4 |
fights ventilator| awake and hyper-alert (exaggerated responses to environmental stimuli) | 5 | 5 |
RSTESTCD = "CBS0104CBS0102" RSTEST = "CBS01-CryingCalmness/Agitation"
quiet breathing, no crying sounds| calm (child appears serene and tranquil) | 1 | 1 |
occasional sobbing or moaning| slightly anxious (child shows slight anxiety) | 2 | 2 |
whining (monotonous sound| anxious (child appears agitated but remains in control) | 3 | 3 |
crying| very anxious (child appears very agitated, just able to control) | 4 | 4 |
screaming or shrieking| panicky (severe distress with loss of control) | 5 | 5 |
RSTESTCD = "CBS0105CBS0103" RSTEST = "CBS01-Physical MovementRespiratory Response"
| RSORRES | RSSTRESC | RSSTRESN |
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| no |
movement| spontaneous respiration | 1 | 1 |
occasional, (three or fewer) slight movements| spontaneous and ventilator respiration | 2 | 2 |
frequent, (more than three) slight movements| restlessness or resistance to ventilator | 3 | 3 |
vigorous movements limited to extremities| actively breathes against ventilator or coughs regularly | 4 | 4 |
vigorous movements including torso and head
RSTESTCD = "CBS0106CBS0104" RSTEST = "CBS01-Muscle ToneCrying"
muscles totally relaxed; no muscle tone| quiet breathing, no crying sounds | 1 | 1 |
reduced muscle tone; less resistance than normal| occasional sobbing or moaning | 2 | 2 |
normal muscle tone| whining (monotonous sound) | 3 | 3 |
increased muscle tone and flexion of fingers and toesextreme muscle rigidity and flexion of fingers and toes
RSTESTCD = "CBS0107CBS0105" RSTEST = "CBS01-Facial TensionPhysical Movement"
facial muscles totally relaxednormal facial tone| occasional, (three or fewer) slight movements | 2 | 2 |
tension evident in some facial muscles (not sustained)| frequent, (more than three) slight movements | 3 | 3 |
tension evident throughout facial muscles (sustained)| vigorous movements limited to extremities | 4 | 4 |
facial muscles contorted and grimacing| vigorous movements including torso and head | 5 | 5 |
RSTESTCD = "CBS0109CBS0106" RSTEST = "CBS01-NRS PainMuscle Tone"
deeply asleep (eyes closed, no response to changes in the environment)| muscles totally relaxed; no muscle tone | 1 | 1 |
lightlylightly asleep (eyes mostly closed, occasional responses)| reduced muscle tone; less resistance than normal | 2 | 2 |
drowsy (child closes his/her eyes frequently, less responsive to the environment)awake and alert (child responsive to the environment)| increased muscle tone and flexion of fingers and toes | 4 | 4 |
awake and hyper-alert (exaggerated responses to environmental stimuli) | | extreme muscle rigidity and flexion of fingers and toes | 5 | 5 |
RSTESTCD = "CBS0110CBS0107" RSTEST = "CBS01-NISSFacial Tension"
insufficient sedation| facial muscles totally relaxed | 1 | 1 |
adequate sedationoversedation| tension evident in some facial muscles (not sustained) | 3 | 3 |
| Info |
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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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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.
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| tension evident throughout facial muscles (sustained) | 4 | 4 |
| facial muscles contorted and grimacing | 5 | 5 |
RSTESTCD = "CBS0110" RSTEST = "CBS01-NISS"
| RSORRES | RSSTRESC | RSSTRESN |
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| insufficient sedation | 1 | 1 |
| adequate sedation | 2 | 2 |
| oversedation | 3 | 3 |
5 Supplemental Qualifier Name Codes
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The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS Clinical Classifications (SUPPRS) special purpose dataset.
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| -wrap |
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| QNAM | QLABEL | QVAL |
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| RSANTXLO | Anchor Text Low | no pain | | RSANTXHI | Anchor Text High | worst pain possible | | RSANVLLO | Anchor Value Low | 0 | | RSANVLHI | Anchor Value High | 10 | | RSCBRFL | Conditionally Branched Item Flag | Y | | QNAM | QLABEL | QVAL |
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| Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT). | Label for QNAM (e.g., Contact Type) | Value of QNAM ( e.g., SUBJECT VISIT) |
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End of Document