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

Transcription

1 Columbia-Suicide Severity Rating Scale Baseline ( ) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by CDISC and Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Notes to Readers This implementation guide is intended 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. Revision History Date Version Summary of Changes Columbia-Suicide Severity Rating Scale Baseline ( ) Draft Columbia-Suicide Severity Rating Scale Baseline ( ) Released Columbia-Suicide Severity Rating Scale 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,

2 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) Reasons on page 9 to Does not apply. Added QS terminology reference 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2

3 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) 1 Introduction This document describes the CDISC implementation of the Baseline questionnaire, a standard questionnaire administered on a CRF that is typically used in clinical trials to identify subjects at risk for suicidal ideation and behavior. The CRF preceded the CDISC CDASH CRF standards and based on its copyright status, cannot be modified to CDASH standards. The representation of data collected for this questionnaire is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) QS domain table, which can be found at the CDISC website at: ( These specific implementation details for this specific questionnaire are meant to be used in conjunction with the SDTMIG, but are recorded separately since this questionnaire may be used in many different therapeutic area implementations. All questionnaire documentation can be found on the CDISC web site at: ( The CDISC Intellectual Property Policy can be found on the CDISC web site at: ( 1.1 Representations and Warranties, Limitations of Liability, and Disclaimers This document is a supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material. 2 Copyright Status CDISC has obtained permission to include the Baseline questionnaire as part of CDISC Data Standards. This means that CDISC developed QSTESTCD and QSTEST for each question based on the actual question text on the questionnaire. The instrument itself was not changed. The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples and (3) case report forms annotated with the CDISC SDTMIG submission values. Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should be accessed through the CDISC website. ( CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder. CDISC acknowledges Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; Burke, A.; Oquendo, M.; Mann, J.; copyright 2008 The Research 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

4 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) Foundation for Mental Hygiene, Inc. for the agreement to include the Columbia-Suicidality Severity Rating Scale () baseline version scale in the CDISC data standards. The copyright owner s consent ensures that the data captured using this instrument will be done so in a standardized manner thereby facilitating collection, database storage, reporting and regulatory review of that data. CDISC wants to emphasize that the existing copyright status as well as the existing procedures for licensing fees and using the instrument will remain exactly as they have been. Please follow the instrument owners own mechanisms for permissions and licenses if you have a need to use this questionnaire. 3 The QS Domain Model 3.1 Assumptions for Questionnaire Domain Model All assumptions for the QS domain from the SDTMIG apply for this supplemental implementation guide including those referenced in the CDISC notes. Additionally, the following assumptions apply to the Columbia-Suicide Severity Rating Scale Baseline Form: 1. Columbia-Suicide Severity Rating Scale Baseline Form ( ): C- SSRS Baseline is a suicidal ideation rating scale. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." 2. The time period of evaluation is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. Specific points in time should use the QSDTC field. In cases where the evaluation interval cannot be precisely described as an ISO 8601 duration, the evaluation period should be represented using the Supplemental Qualifier QNAM=EVLINTTX. 3. The evaluator of the questionnaire is stored in QSEVAL and for the form the INVESTIGATOR provides the evaluation. 4. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for QSSCAT, QSORRES, QSSTRESC and QSSTRESN fields is provided in Section 4: Mapping Strategy. 3.2 Example for Columbia-Suicide Severity Rating Scale Baseline Domain Model The Baseline example below shows the terminology used to implement the questionnaire in the QS domain. The evaluation interval for this questionnaire is over the lifetime of the subject and is represented in SUPPQS with QNAM=EVLINTTX Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) Example: Columbia-Suicide Severity Rating Scale Baseline ( Baseline) This example shows data from one subject collected at one visit for a Baseline questionnaire. The example uses controlled terminology for QSTESTCD, QSTEST, QSCAT and QSSORRES for the measure. Rows 1-39: Represent the questions from the Form. All original results are represented with the standard values in QSORRES. This result is then transformed into a Standard Numeric score in QSSTRESN. Row 8, 10 and 27 are for illustrative purposes in order to display the QSTESTCD/QSTEST values and contain the value of XXX, the actual missing record would not be created in the QS domain qs.xpt Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSEVAL VISITNUM CSS01-Wish to 1 STUDYX QS 1 CSS0101 Yes Y INVESTIGATOR 1 be Dead CSS01-Wish to 2 STUDYX QS 2 CSS0101A be Dead, Wish dead Wish dead INVESTIGATOR 1 Describe 3 STUDYX QS 4 STUDYX QS 5 STUDYX QS 6 STUDYX QS 3 CSS CSS0102A 5 CSS CSS0103A CSS01-Non- Specific Suicidal Thought CSS01-Non- Specific Suicid Thought, Descr CSS01-Suicidal Ideation-No Intent CSS01-Suicidal Ideation-No Intent, Descr Yes Y INVESTIGATOR 1 I have thought about killing myself I have thought about killing myself INVESTIGATOR 1 Yes Y INVESTIGATOR 1 I thought about taking an overdose but I never made a specific plan I thought about taking an overdose but I never made a specific plan INVESTIGATOR 1 7 STUDYX QS 8 STUDYX QS 9 STUDYX QS 10 STUDYX QS 11 STUDYX QS 12 STUDYX QS 7 CSS CSS0104A 9 CSS CSS0105A 11 CSS CSS0106A CSS01-Ideation With Intent, No Plan CSS01-Ideation With Intent No Plan Descr CSS01-Ideation With Plan/Intent CSS01-Ideation With Plan/Intent, Descr Severe Ideation Severe Ideation, Description No N INVESTIGATOR 1 XXX INVESTIGATOR 1 No N INVESTIGATOR 1 XXX INVESTIGATOR INVESTIGATOR 1 Some intent to act on suicidal thoughts Some intent to act on suicidal thoughts INVESTIGATOR Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

6 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSEVAL VISITNUM 2-5 times in 13 STUDYX QS 13 CSS0107 Severe Ideation, 3 3 INVESTIGATOR 1 week Frequency 14 STUDYX QS 15 STUDYX QS 16 STUDYX QS 17 STUDYX QS 14 CSS CSS CSS CSS0111 Severe Ideation, Duration Severe Ideation, Control Severe Ideation, Deterrents Severe Ideation, Reasons Less than 1 hour/some of the time Can control thoughts with a lot of difficulty Deterrents definitely did not stop you Mostly to get attention, revenge or a reaction from others 2 2 INVESTIGATOR INVESTIGATOR INVESTIGATOR INVESTIGATOR 1 CSS01-Actual 18 STUDYX QS 18 CSS0112 Attempt Yes Y INVESTIGATOR 1 19 STUDYX QS CSS01-Number 19 CSS0113 of Actual Attempts INVESTIGATOR 1 20 STUDYX QS CSS01-Actual Try to get Try to get 20 CSS0113A Attempt, injured to get injured to get Describe attention attention INVESTIGATOR 1 21 STUDYX QS CSS01-Nonsuicidal Self- 21 CSS0114 injurious Behav Yes Y INVESTIGATOR 1 22 STUDYX QS CSS01-22 CSS0115 Interrupted Attempt Yes Y INVESTIGATOR 1 23 STUDYX QS CSS01-Number 23 CSS0116 of Interrupted Attempts INVESTIGATOR 1 CSS01-24 STUDYX QS Interrupted Stopped from Stopped from 24 CSS0116A Attempt, overdose overdose INVESTIGATOR 1 Describe 25 STUDYX QS CSS01-Aborted 25 CSS0117 Attempt No N INVESTIGATOR 1 26 STUDYX QS CSS01-Number 26 CSS0118 of Aborted Attempts INVESTIGATOR 1 27 STUDYX QS CSS01-Aborted 27 CSS0118A Attempt, Describe XXX INVESTIGATOR 1 28 STUDYX QS 28 CSS0119 CSS01- Yes Y INVESTIGATOR Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

7 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSEVAL VISITNUM Preparatory Acts/Behavior CSS01-29 STUDYX QS Preparatory 29 CSS0119A Acts/Behavior, Buying pills Buying pills INVESTIGATOR 1 Descr 30 STUDYX QS 31 STUDYX QS 32 STUDYX QS 33 STUDYX QS 34 STUDYX QS 35 STUDYX QS 36 STUDYX QS 37 STUDYX QS 38 STUDYX QS 39 STUDYX QS 30 CSS CSS0121A 32 CSS0121B 33 CSS0121C 34 CSS0122A 35 CSS0122B 36 CSS0122C 37 CSS0123A 38 CSS0123B 39 CSS0123C CSS01-Suicidal Behavior Recent Attempt Date Recent Attempt Damage Recent Attempt Potential Lethal Attempt Date Lethal Attempt Damage Lethal Attempt Potential CSS01-First Attempt Date CSS01-First Attempt Damage CSS01-First Attempt Potential No N INVESTIGATOR INVESTIGATOR 1 Minor physical damage Behavior likely to result in injury but not likely to cause death 1 1 INVESTIGATOR INVESTIGATOR INVESTIGATOR 1 Severe physical damage ehavior likely to result in death despite available medical care 4 4 INVESTIGATOR INVESTIGATOR INVESTIGATOR 1 No physical damage or very minor physical damage Behavior likely to result in injury but not likely to cause death 0 0 INVESTIGATOR INVESTIGATOR Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7

8 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard values for QNAM and QLABEL are listed below. suppqs.xpt STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL STUDYX QS VISITNUM 1 EVLINTTX Evaluation Interval Text LIFETIME CRF 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8

9 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) 4 SDTM Mapping Strategy Baseline specific mapping strategy: This section is used for reference with the annotated CRF for further details on the CRF data capture and to understand the alignment of the questionnaire to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSORRESU, QSSTRESC, QSSTRESN, and QSSTRESU) should be populated for each questionnaire. If a result variable is not included in the table for a questionnaire, it should not be populated. QSSCAT QSTESTCD CSS0101 CSS0105A CSS0106 CSS0111 CSS0112 CSS0123C QSTESTCD= CSS0101 CSS0105 Ideation With Plan/Intent QSORRES Yes No QSTEST= CSS01-Wish to be Dead CSS01- QSSTRESC Y N QSTESTCD= CSS0106 QSTEST= Severe Ideation QSTESTCD= CSS0107 QSTEST= Severe Ideation, Frequency Less than once a week 1 1 Once a week times in week 3 3 Daily or almost daily 4 4 Many times each day 5 5 QSTESTCD= CSS0108 QSTEST= Severe Ideation, Duration Fleeting few seconds or minutes 1 1 Less than 1 hour/some of the time hours/a lot of time hours/most of day Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9

10 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) More than 8 hours/persistent or continuous 5 5 QSTESTCD= CSS0109 QSTEST= Severe Ideation, Control Easily able to control thoughts 1 1 Can control thoughts with little difficulty 2 2 Can control thoughts with some difficulty 3 3 Can control thoughts with a lot of difficulty 4 4 Unable to control thoughts 5 5 Does not attempt to control thoughts 0 0 QSTESTCD= CSS0110 QSTEST= Severe Ideation, Deterrents Deterrents definitely stopped you from attempting suicide 1 1 Deterrents probably stopped you 2 2 Uncertain that deterrents stopped you 3 3 Deterrents most likely did not stop you 4 4 Deterrents definitely did not stop you 5 5 Does not apply 0 0 QSTESTCD= CSS0111 QSTEST= Severe Ideation, Reasons Completely to get attention, revenge or a reaction from others 1 1 Mostly to get attention, revenge or a reaction from others 2 2 Equally to get attention, revenge or a reaction from others and to end/stop the pain 3 3 Mostly to end or stop the pain 4 4 Completely to end or stop pain 5 5 Does not apply 0 0 QSTESTCD= CSS0112 CSS0120 Suicidal Behavior QSORRES Yes No QSTEST= CSS01-Actual Attempt CSS01- QSSTRESC Y N QSTESTCD= CSS0121B QSTEST= Recent Attempt Damage No physical damage or very minor physical damage 0 0 Minor physical damage Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 10

11 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) Moderate physical damage; medical attention needed 2 2 Moderately severe physical damage; medical hospitalization and likely intensive care required 3 3 Severe physical damage; medical hospitalization with intensive care required 4 4 Death 5 5 QSTESTCD= CSS0121C QSTEST= Recent Attempt Potential Behavior not likely to result in injury 0 0 Behavior likely to result in injury but not likely to cause death 1 1 Behavior likely to result in death despite available medical care 2 2 QSTESTCD= CSS0122B QSTEST= Lethal Attempt Damage No physical damage or very minor physical damage 0 0 Minor physical damage 1 1 Moderate physical damage; medical attention needed 2 2 Moderately severe physical damage; medical hospitalization and likely intensive care required 3 3 Severe physical damage; medical hospitalization with intensive care required 4 4 Death 5 5 QSTESTCD= CSS0122C QSTEST= Lethal Attempt Potential Behavior not likely to result in injury 0 0 Behavior likely to result in injury but not likely to cause death 1 1 Behavior likely to result in death despite available medical care 2 2 QSTESTCD= CSS0123B QSTEST= CSS01-First Attempt Damage No physical damage or very minor physical damage 0 0 Minor physical damage 1 1 Moderate physical damage; medical attention needed 2 2 Moderately severe physical damage; medical hospitalization and likely intensive care required 3 3 Severe physical damage; medical hospitalization with intensive care required 4 4 Death Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 11

12 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) QSTESTCD= CSS0123C QSTEST= CSS01-First Attempt Potential Behavior not likely to result in injury 0 0 Behavior likely to result in injury but not likely to cause death 1 1 Behavior likely to result in death despite available medical care Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 12

13 CDISC SDTM Baseline Questionnaire Supplement (Version 1.1) 5 Supplemental Qualifier Name Codes The following table contains additional standard name codes for use in the Supplemental Qualifiers for Questionnaires (SUPPQS) special-purpose dataset. QNAM QLABEL Applicable Domains EVLINTTX Evaluation Interval Text QS End of Document 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 13