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Green = Recent FDA Changes Pink = Instructional information for developers Blue = Text can change from supplement to supplement based on the instrument Black = Standard template language |
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title | Instructions on how to use this template |
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Copy QS Template page and move to the Initial development (not ready for review) page. Please DO NOT OVERWRITE the template pages.- If the supplement is based on a measurement system, such as PRO-CTCAE V1.0, FACIT, PROMIS, etc., replace the word instrument with measurement system throughout the supplement.
The "–" in this template represents the domain implemented for the instrument. This is replaced with the 2-character domain abbreviation of FT, QS, or RS that is used for the instrument.Change the title of the page as follows: - Remove 'Copy of QRS Supplement Template - '.
- Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
- Change 'QRS Short_Name' to the short name (--CAT) for the current instrument.
Update the information in the Page Properties block below as indicated in the block below.- The supplement version number in the header section will be 'v1' if there has never been a supplement for the instrument before. Otherwise, increment as appropriate.
- If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.
Replace 'Title' and 'QRS Short_Name' throughout the document with the title and short name of the instrument that the supplement is being created for. Replace royal blue text with information pertaining to the instrument the supplement is being created for. Delete royal blue text which does not apply to the new instrument. Unless otherwise noted, text in black applies to all QRS Supplements and should not be deleted, but should be examined carefully and revised as appropriate based on the specific instrument supplement as needed. Any changes need to be in blue font to stand out for review.Change QS to RS or FT and 'Questionnaires' to 'Disease Response and Clin Classification' or 'Functional Tests' as appropriate.Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.Keep changes in blue for ease throughout internal and public review. Once the supplement has gone thru public review and all comments are resolved, change all text color to black except for hyperlinks.Arabic numerals (0, 1, 2, 3, etc.)are used to express numbers in most circumstances. Exceptions are the following: Info |
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title | Information for Reviewers |
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Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument. |
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Title | Comfort Behavior Scale (COMFORT-B SCALE) |
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CDISC Reference | Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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QRS Short Name | |
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QRS Permission Status | Approved |
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Team | CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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Supplement Version | 1.0 |
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Status | DRAFT |
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, Ratings, and Scales (QRS) Subteam | Supplement Version | 1.0 |
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Status | DRAFT |
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Date | 2024-04-08 | Date | 2023-12-05 (date current version released, regardless of status - this date should always match the date in the Revision History section below and should be updated every time this supplement is edited.) |
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Notes to Readers | - This supplement is available to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
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Revision History
Date | Version |
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20232024-1204-0508 | 1.0 Draft |
© 2023 Clinical 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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title | Information for Reviewers |
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The CRF is attached at the top of the Wikiwiki. When you click the paperclip image, you will find the file for the annotated CRF. |
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The COMFORT-B SCALE is a multiple-choice instrument that clinicians may use in peadiatric pediatric intensive care units to assessyoung children's pain and distress. It consists of 6 behavior items, each rated on a 5-point scale describing the different intensities of the behavior in question. Summating the 6 ratings leads to a total score between 6-30, also captured.
The scale points include a numeric rating (1-5) and a definition of what is represented by the rating (e.g., 1 = "deeply asleep (eyes closed, no response to changes in the environment)"). For the COMFORT-B SCALE, RSORRES is populated with the text description while ; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
Visual analog or numeric rating scales used within a questionnaire with a range of text and numeric values are indicated in the SUPPRS domain with:
QNAM="RSANTXLO" QNAM="RSANTXHI"
QNAM="RSANVLLO" QNAM="RSANVLHI"
By storing this information in SUPPRS, it is available for interpretation purposes.
The When the value of the data being represented equals a low or high anchor value, the corresponding low and high anchor text is stored in RSORRES with the numeric values stored in RSSTRESC and RSSTRESN. All other numeric values are stored in RSORRES, RSSTRESC and RSSTRESN.- RSMETHOD is populated with "NUMERICAL RATING SCALE 11-POINT" when RSTESTCD="CBS0109". The NRS is a global pain rating scale (0 ="no pain" and 10 ="worst imaginable pain").
- In addition of to the NRS, the level of sedation (NISS="Nurse Interpretation of Sedation Score") is categorized as 1 = "insufficient sedation", 2 = "adequate sedation" and , or 3 = "oversedation".
- The RSREPNUM variable is used to indicate the same RSTESTSs are used in trial 1, 2, 3, and 4.
Records are created in rs.xpt for every instrument item:
For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE". If the reason is known, then that reason is represented in RSREASND (e.g., RSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND is missing.
- Due to the variability of copyright holder and public domain derived subscore and overall score generation processes, records are not included for derived subscores or overall scores that are not provided.
Some items on the COMFORT-B SCALE may be conditionally branched per the instrument instructions. Only Either Respiratory Ventilation or Crying (RSTESTCD = "CBS0103" or "CBS0104") is completed for each subject. Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | QRSSUPP-759 |
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The other will be treated as a conditionally branched item. A record is created in rs.xpt for all items. When an item is considered a conditionally branched item, it is represented as follows:
- QNAM = “RSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a RS supplemental qualifier variable related to the record).
- RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).
The COMFORT-B SCALE instrument includes a total score that is considered as captured data on the instrument 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 Monique van Dijk en Erwin Ista.
- Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
- If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.It is the sponsors sponsor's responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
Terminology
RSCAT, RSTESTCD, RSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.
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We are unable to make the example consistently show blue in the Wikiwiki. All examples are updated for each QRS instrument, so we ask that you please review the example below. |
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Rows 1-48: | Represent the questions from the Comfort-B Scale for subject 2324-P0001 at visit 1. Row 4 represents the conditional branching item for the item "Crying". The full representation is done for RSREPNUM=1, and partial representations are done for RSREPNUM=2, 3 and 4. | Rows 49-96: | Represent the missing data from the Comfort-B Scale for subject 2324-P0001 at visit 2. Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, and no date is assumed for when the visit would have occurred. The following The variable RSMETHOD is also not represented when this happens. |
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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 | lightly 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 | 13 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | deeply asleep (eyes closed, no response to changes in the environment) | 1 | 1 |
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| Y | 2 | 1 | 2023-05-15 | ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 24 | STUDYX | RS | 2324-P0001 | 24 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
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| Y | 2 | 1 | 2023-05-15 | 25 | STUDYX | RS | 2324-P0001 | 25 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
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| Y | 3 | 1 | 2023-05-15 | ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 36 | STUDYX | RS | 2324-P0001 | 36 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
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| Y | 3 | 1 | 2023-05-15 | 37 | STUDYX | RS | 2324-P0001 | 37 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
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| Y | 4 | 1 | 2023-05-15 | ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 48 | STUDYX | RS | 2324-P0001 | 48 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
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| Y | 4 | 1 | 2023-05-15 | 49 | STUDYX | RS | 2324-P0001 | 49 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 50 | STUDYX | RS | 2324-P0001 | 50 | CBS0102 | CBS01-Calmness/Agitation | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 51 | STUDYX | RS | 2324-P0001 | 51 | CBS0103 | CBS01-Respiratory Response | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 52 | STUDYX | RS | 2324-P0001 | 52 | CBS0104 | CBS01-Crying | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 53 | STUDYX | RS | 2324-P0001 | 53 | CBS0105 | CBS01-Physical Movement | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 54 | STUDYX | RS | 2324-P0001 | 54 | CBS0106 | CBS01-Muscle Tone | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 55 | STUDYX | RS | 2324-P0001 | 55 | CBS0107 | CBS01-Facial Tension | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 56 | STUDYX | RS | 2324-P0001 | 56 | CBS0108 | CBS01-Total Score | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 57 | STUDYX | RS | 2324-P0001 | 57 | CBS0109 | CBS01-NRS Pain | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 58 | STUDYX | RS | 2324-P0001 | 58 | CBS0110 | CBS01-NISS | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 59 | STUDYX | RS | 2324-P0001 | 59 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 60 | STUDYX | RS | 2324-P0001 | 60 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 1 | 2 |
| 61 | STUDYX | RS | 2324-P0001 | 61 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 2 | 2 |
| ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 72 | STUDYX | RS | 2324-P0001 | 72 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 2 | 2 |
| 73 | STUDYX | RS | 2324-P0001 | 73 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 3 | 2 |
| ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 84 | STUDYX | RS | 2324-P0001 | 84 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 3 | 2 |
| 85 | STUDYX | RS | 2324-P0001 | 85 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| NOT DONE |
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| 4 | 2 |
| ... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | 96 | STUDYX | RS | 2324-P0001 | 96 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| NOT DONE |
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| 4 | 2 |
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The following table contains additional standard name codes for use in the Supplement Qualifiers for Clinical Classifications (SUPPRS) special purpose dataset.
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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 |
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End of Document