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DateVersionSummary of Changes
2022-08-221.3 Draft
  • Converted the supplement to the current WIKI QRS supplement template.
  • Annotated CRF updated to the MSG V2.0 annotation guidelines, including following updates:

a. Change of QSEVLINT to QSEVINTX for the Evaluation Interval Text of "LIFETIME"

b. Added annotations for QSSTRESC/QSSTRESN wherever applicable

  • Added the first assumption to include details on every item of the instrument.
  • The QSEVAL and QSEVALID assumption and variables were removed from this supplement since it is not captured on the CRF and no assumptions are made on the potential values.
  • Added assumptions 4, 5 and 6 for conditional branching. The example was updated to include records for these items.
  • Added QSLOBXFL variable to the example to represent a baseline response for visit 1
  • Added example to represent skipped visit (VISITNUM = 2)
  • Added QSDRVFL variable to the example to represent items not done due to conditional branching.
  • Section 4 (SDTM mapping strategy): Added an additional column in the table for "Most Recent Attempt", "Most Lethal Attempt" and "Initial/First Attempt" (QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B")  to indicate CRF Text over 200 characters
  • Added example for SUPPQS dataset
  • Added section 5 Supplemental Qualifier Name Codes.
2014-09-031.2

  • Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised:

    • Updated references to QSCAT and questionnaire name throughout the document.
    • Section 3.1: Assumption # 2 – Evaluation Interval mapped to QSEVINTX (from EVLINTTX).
    • Section 3.2: Updated text above example table. Example table updated to include QSEVINTX in the QS table. Removed the SUPPQS.xpt table.
    • Section 4: (SDTM Mapping Strategy) for QSTESTCD=CSS0111.

      Old value: Completely to end or stop pain
      New value: Completely to end or stop the pain
2013-02-061.1

Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised:

  • QSSCAT added to be compatible with all CSSR-S questionnaires
  • QSTPT replaced with QNAM=EVLINTTX to be compatible with all CSSR-S questionnaires using evaluation intervals
  • Corrected "Dose not apply", associated with the Most Severe Ideation, Reasons on page 9 to "Does not apply".
  • Added QS terminology reference
2012-08-071.0

Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Released

2012-03-030.1Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Draft

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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.

QSSCATQSTESTCD
SUICIDAL IDEATIONQSSS0101 - CSS0105A
INTENSITY OF IDEATIONCSS0106 - CSS0111
SUICIDAL BEHAVIORCSS0112 - CSS0123C


QSTESTCD = "CSS0106" QSTEST = "CSS01-Most Severe Ideation"

QSORRES

QSSTRESC

QSSTRESN

111
222
333
444
555


QSTESTCD = "CSS0101" QSTEST = "CSS01-Wish to be Dead"

...

QSTESTCD = "CSS0120" QSTEST= "CSS01-Suicidal Behavior"

QSORRES

QSSTRESC

YesY
NoN


QSTESTCD = "CSS0107" QSTEST = "CSS01-Most Severe Ideation, Frequency"

QSORRES

QSSTRESC

QSSTRESN

Less than once a week11
Once a week22
2-5 times in week33
Daily or almost daily44
Many times each day55


QSTESTCD = "CSS0108" QSTEST = "CSS01-Most Severe Ideation, Duration"

QSORRES

QSSTRESC

QSSTRESN

Fleeting – few seconds or minutes11
Less than 1 hour/some of the time22
1-4 hours/a lot of time33
4-8 hours/most of day44
More than 8 hours/persistent or continuous55


QSTESTCD = "CSS0109" QSTEST = "CSS01-Most Severe Ideation, Control"

QSORRES

QSSTRESC

QSSTRESN

Easily able to control thoughts11
Can control thoughts with little difficulty22
Can control thoughts with some difficulty33
Can control thoughts with a lot of difficulty44
Unable to control thoughts55
Does not attempt to control thoughts00


QSTESTCD = "CSS0110" QSTEST = "CSS01-Most Severe Ideation, Deterrents"

QSORRES

QSSTRESC

QSSTRESN

Deterrents definitely stopped you from attempting suicide11
Deterrents probably stopped you22
Uncertain that deterrents stopped you33
Deterrents most likely did not stop you44
Deterrents definitely did not stop you55
Does not apply00


QSTESTCD = "CSS0111" QSTEST = "CSS01-Most Severe Ideation, Reasons"

QSORRES

QSSTRESC

QSSTRESN

Completely to get attention, revenge or a reaction from others11
Mostly to get attention, revenge or a reaction from others22
Equally to get attention, revenge or a reaction from others and to end/stop the pain33
Mostly to end or stop the pain (you couldn’t go on living with the pain or how you were feeling)44
Completely to end or stop the pain (you couldn’t go on living with the pain or how you were feeling)55
Does not apply00


QSTESTCD = "CSS0121B" QSTEST = "CSS01-Most Recent Attempt Damage"

...

QSTESTCD = "CSS0123B" QSTEST = "CSS01-First Attempt Damage"

QSORRES

QSSTRESC

QSSTRESN

No physical damage or very minor physical damage00
Minor physical damage11
Moderate physical damage; medical attention needed22
Moderately severe physical damage; medical hospitalization and likely intensive care required33
Severe physical damage; medical hospitalization with intensive care required44
Death55


QSTESTCD = "CSS0121C" QSTEST = "CSS01-Most Recent Attempt Potential"

...

QSTESTCD = "CSS0123C" QSTEST = "CSS01-First Attempt Potential"

QSORRES

QSSTRESC

QSSTRESN

Behavior not likely to result in injury00
Behavior likely to result in injury but not likely to cause death11
Behavior likely to result in death despite available medical care22


5 Supplemental Qualifier Name Codes

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