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CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1 May 30, 2014
Extended Glasgow Outcome Scale
(GOSE)
Questionnaire Supplement to the Study Data
Tabulation Model Implementation Guide
for Human Clinical Trials
Prepared by
TBI Standards Team and CDISC Questionnaire Sub-team
Notes to Readers
This supplement 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
2014-05-08 1.0 Extended Glasgow Outcome Scale (GOSE) Draft
2014-05-30 1.0 Extended Glasgow Outcome Scale (GOSE)
CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2 May 30, 2014
1 Introduction This document describes the CDISC implementation of the Extended Glasgow Outcome Scale
(GOSE) questionnaire, a standard questionnaire that is typically used in clinical trials to provide
an assessment of the severity of traumatic brain injury. It is a global scale for functional
outcome that rates patient status into one of eight categories.
The GOSE questionnaire preceded the CDISC CDASH CRF standards and based on its public
domain 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 model, which can be found at the CDISC
website at: (http://www.cdisc.org/sdtm).
These specific implementation details for this questionnaire are meant to be used in conjunction
with the SDTMIG. All questionnaire documentation can be found on the CDISC web site at:
(http://www.cdisc.org/content2909).
The CDISC Intellectual Property Policy can be found on the CDISC web site at:
(http://www.cdisc.org/bylaws-and-policies).
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 This instrument is in the public domain. CDISC has included the Extended Glasgow Outcome Scale
(GOSE) as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST for
each question based on the actual question text on the questionnaire. There may be many versions of
this questionnaire in the public domain or copyright questionnaire. CDISC has chosen to use this
version as the data standard.
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. (http://www.cdisc.org/terminology)
The reference for this questionnaire is:
Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale
and the Extended Glasgow Outcome Scale: Guidelines for their use. Journal of Neurotrauma
1998;15:573-585.
CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3 May 30, 2014
3 The QS Domain Model
3.1 Assumptions for Questionnaire Domain Model
All assumptions and business rules described in the SDTMIG QS domain are applicable
to this supplement. Additional assumptions specific to the Extended Glasgow Outcome
Scale questionnaire are listed below.
The questionnaire consists of twenty-two items, set apart in seven subsections (indicated
by QSSCAT level in SDTM) about quality of life. Four are multiple choice items
whereas the remainder of the items are yes/no. Ratings are made during a brief interview
of the patient and/or someone familiar with the patient’s background and current state of
responsiveness.
1. The Extended Glasgow Outcome Scale (GOSE) is a hierarchical scale in which the
patient’s overall rating [score] is based on the lowest outcome category indicated by
the response to the questionnaire. For example, when a patient has answered that
they are unable to work to Question 5b, which would indicate Lower Moderate
Disability, but they have already responded that they need frequent help in the home
to Question 2b, which would indicate Lower Severe Disability, the total score will be
3=Lower Severe Disability (Lower SD).
The minimum possible total score is 1 (DEAD); the maximum is 8 [Upper Good
Recovery (Upper GR)]. When it is possible to be diagnosed with a given outcome,
the definition corresponding to the number of the response includes an outcome
abbreviation [e.g. 1=No (Upper SD)].
Only the text [e.g. No (Upper SD)] is included in QSORRES as the numbers do not
contribute to the total score.
2. Some questions have multiple dependent parts. If a leading question is answered in a
way in which the next question(s) is skipped, the related question(s) will not appear in
SDTM.
3. Questions on the GOSE regarding the existence of a given condition prior to the injury do
not automatically lead to a GOSE total score, but are there for the evaluator to consider in
adjusting the GOSE total score. Scores may be adjusted to a higher level of disability
(lower score) if the patient’s ability in a given area is markedly worse than prior to the
brain injury. Epilepsy questions similarly are on the instrument only for
consideration of the evaluator in adjusting the total score.
4. The Interviewer question on the CRF is the questionnaire evaluator, which is stored in
QSEVAL. The Interviewer identification (.ex initials), to further distinguish the rater in
QSEVAL, are stored in QSEVALID.
a. The Respondent question on the CRF corresponds to the Primary Source of
Information providing the responses on the CRF. This value is stored in
SUPPQS with the QNAM=PRIMSRC. For GOSE, the respondent is defined as
either PATIENT ALONE, RELATIVE/ FRIEND/ CARER ALONE, OR
PATIENT + RELATIVE/ FRIEND/ CARER.
CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4 May 30, 2014
5. Terminology:
a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology.
b. A full list of value sets for qualifier and result fields is provided in Section 4:
SDTM Mapping Strategy.
CDISC SDTM DS Questionnaire Supplement (Version 1.0)
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5 May 30, 2014
3.2 Example for Extended Glasgow Outcome Scale (GOSE) QS Domain Model
The GOSE example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for two
subjects collected at one visit for a GOSE questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT.
QSBLFL is NULL based on VISITNUM=2. All original results are represented with preferred terminology in QSORRES. When applicable, this
result is then transformed into a standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.
Rows 1-23: Represent the questions from the GOSE form for USUBJID P0001. This subject has difficulties with many qualities of life, as
reflected by the need to respond to all questions.
Row 3: Based on the result of QSTESTCD= GOSE102B , USUBJID= P0001 met the criteria for Lower Severe Disability (higher scores; see
Rows 5, 7, 10, 13, 16, and 18 were not used in determining the total score (Row 23)).
Rows 4, 6, 8, 11, 14, 17, and 19: Subject P0001 did not have any of these quality of life problems before the injury, but the evaluator chose not to
adjust their total score (Row 23).
Rows 24-42: Represent the questions from the GOSE form for USUBJID P0002. This subject had some areas of their quality of life which were
not good and some which had no problems, so many questions for further details about problems were skipped.
Row 25: Since subject P0002 answered that daily assistance at home was not essential (question 2A), questions 2B and 2C were skipped and
there is no record for these questions.
Row 31: Subject P0002 met the criteria for Upper Moderate Disability so their lower levels of disability (higher scores; see Rows 34 and 37)
were not used in determining the total score (Row 42)
Row 32: Subject P0002 was working before the injury so the interviewer considered this in determining the total score (Row 42).
CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6 May 30, 2014
qs.xpt Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN
1 STUDYX QS P0001 1 GOSE101 GOSE1-Obey Simple Commands or Say
Words GOSE Yes Y
2 STUDYX QS P0001 2 GOSE102A GOSE1-Daily Assistance at Home Essential GOSE Yes Y
3 STUDYX QS P0001 3 GOSE102B GOSE1-Need Frequent Help at Home GOSE Yes (Lower SD) Yes (Lower SD)
4 STUDYX QS P0001 4 GOSE102C GOSE1-Assistance at Home Before Injury GOSE No N
5 STUDYX QS P0001 5 GOSE103A GOSE1-Shop Without Assistance GOSE No (Upper SD) No (Upper SD)
6 STUDYX QS P0001 6 GOSE103B GOSE1-Shop Without Assist Before Injury GOSE Yes Y
7 STUDYX QS P0001 7 GOSE104A GOSE1-Travel Locally Without Assistance GOSE No (Upper SD) No (Upper SD)
8 STUDYX QS P0001 8 GOSE104B GOSE1-Travel Without Assist Before Inj GOSE Yes Y
9 STUDYX QS P0001 9 GOSE105A GOSE1-Able to Work to Previous Capacity GOSE No N
10 STUDYX QS P0001 10 GOSE105B GOSE1-How Restricted Are They GOSE b (Lower MD) b (Lower MD)
11 STUDYX QS P0001 11 GOSE105C GOSE1-Working Before Injury GOSE Yes Y
12 STUDYX QS P0001 12 GOSE106A GOSE1-Resume Social/Leisure Outside
Home GOSE No N
13 STUDYX QS P0001 13 GOSE106B GOSE1-Extent Social/Leisure Restriction GOSE c (Lower MD) c (Lower MD)
14 STUDYX QS P0001 14 GOSE106C GOSE1-Engage Social/Leisure Before Inj GOSE Yes Y
15 STUDYX QS P0001 15 GOSE107A GOSE1-Disruptive Psychological Problems GOSE Yes Y
16 STUDYX QS P0001 16 GOSE107B GOSE1-Extent of Disruption GOSE c (Lower MD) c (Lower MD)
17 STUDYX QS P0001 17 GOSE107C GOSE1-Family/Friends Probs Before Injury GOSE No N
18 STUDYX QS P0001 18 GOSE108A GOSE1-Other Problems Related to Injury GOSE Yes (Lower GR) Yes (Lower GR)
19 STUDYX QS P0001 19 GOSE108B GOSE1-Similar Problems Before Injury GOSE No N
20 STUDYX QS P0001 20 GOSE109 GOSE1-Since Injury Any Epileptic Fits GOSE No N
21 STUDYX QS P0001 21 GOSE110 GOSE1-At Risk of Developing Epilepsy GOSE No N
22 STUDYX QS P0001 22 GOSE111 GOSE1-Most Important Factor in Outcome GOSE Effects of head injury Effects of head
injury
23 STUDYX QS P0001 23 GOSE112 GOSE1-GOSE Overall Score GOSE Lower Severe Disability (Lower SD) 3 3
24 STUDYX QS P0002 24 GOSE101 GOSE1-Obey Simple Commands or Say
Words GOSE Yes Y
25 STUDYX QS P0002 25 GOSE102A GOSE1-Daily Assistance at Home Essential GOSE No N
CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
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Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN
26 STUDYX QS P0002 26 GOSE103A GOSE1-Shop Without Assistance GOSE Yes Y
27 STUDYX QS P0002 27 GOSE103B GOSE1-Shop Without Assist Before Injury GOSE Yes Y
28 STUDYX QS P0002 28 GOSE104A GOSE1-Travel Locally Without Assistance GOSE Yes Y
29 STUDYX QS P0002 29 GOSE104B GOSE1-Travel Without Assist Before Inj GOSE Yes Y
30 STUDYX QS P0002 30 GOSE105A GOSE1-Able to Work to Previous Capacity GOSE No N
31 STUDYX QS P0002 31 GOSE105B GOSE1-How Restricted Are They GOSE a (Upper MD) a (Upper MD)
32 STUDYX QS P0002 32 GOSE105C GOSE1-Working Before Injury GOSE Yes Y
33 STUDYX QS P0002
33 GOSE106A GOSE1-Resume Social/Leisure Outside
Home GOSE No N
34 STUDYX QS P0002 34 GOSE106B GOSE1-Extent Social/Leisure Restriction GOSE a (Lower GR) a (Lower GR)
35 STUDYX QS P0002 35 GOSE106C GOSE1-Engage Social/Leisure Before Inj GOSE Yes Y
36 STUDYX QS P0002 36 GOSE107A GOSE1-Disruptive Psychological Problems GOSE No N
37 STUDYX QS P0002 37 GOSE108A GOSE1-Other Problems Related to Injury GOSE No (Upper GR) No (Upper GR)
38 STUDYX QS P0002 38 GOSE108B GOSE1-Similar Problems Before Injury GOSE No N
39 STUDYX QS P0002 39 GOSE109 GOSE1-Since Injury Any Epileptic Fits GOSE No N
40 STUDYX QS P0002 40 GOSE110 GOSE1-At Risk of Developing Epilepsy GOSE No N
41 STUDYX QS P0002 41 GOSE111 GOSE1-Most Important Factor in Outcome GOSE Effects of head injury Effects of head
injury
42 STUDYX QS P0002 42 GOSE112 GOSE1-GOSE Overall Score GOSE Lower Moderate Disability (Lower
MD) 5 5
Row QSBLFL QSSCAT QSEVAL QSEVALID VISITNUM QSDTC
1 (cont) CONSCIOUSNESS INTERVIEWER GEC 2 2014-11-16
2 (cont) INDEPENDENCE IN THE HOME INTERVIEWER GEC 2 2014-11-16
3 (cont) INDEPENDENCE IN THE HOME INTERVIEWER GEC 2 2014-11-16
4 (cont) INDEPENDENCE IN THE HOME INTERVIEWER GEC 2 2014-11-16
5 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16
6 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16
7 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16
CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
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Row QSBLFL QSSCAT QSEVAL QSEVALID VISITNUM QSDTC
8 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16
9 (cont) WORK INTERVIEWER GEC 2 2014-11-16
10 (cont) WORK INTERVIEWER GEC 2 2014-11-16
11(cont) WORK INTERVIEWER GEC 2 2014-11-16
12 (cont) SOCIAL & LEISURE ACTIVITIES INTERVIEWER GEC 2 2014-11-16
13 (cont) SOCIAL & LEISURE ACTIVITIES INTERVIEWER GEC 2 2014-11-16
14 (cont) SOCIAL & LEISURE ACTIVITIES INTERVIEWER GEC 2 2014-11-16
15 (cont) FAMILY & FRIENDSHIPS INTERVIEWER GEC 2 2014-11-16
16 (cont) FAMILY & FRIENDSHIPS INTERVIEWER GEC 2 2014-11-16
17 (cont) FAMILY & FRIENDSHIPS INTERVIEWER GEC 2 2014-11-16
18 (cont) RETURN TO NORMAL LIFE INTERVIEWER GEC 2 2014-11-16
19 (cont) RETURN TO NORMAL LIFE INTERVIEWER GEC 2 2014-11-16
20 (cont) EPILEPSY INTERVIEWER GEC 2 2014-11-16
21 (cont) EPILEPSY INTERVIEWER GEC 2 2014-11-16
22 (cont) OUTCOME FACTOR INTERVIEWER GEC 2 2014-11-16
23 (cont) INTERVIEWER GEC 2 2014-11-16
24 (cont) CONSCIOUSNESS INTERVIEWER GEC 2 2014-11-16
25 (cont) INDEPENDENCE IN THE HOME INTERVIEWER GEC 2 2014-11-16
26 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16
27 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16
28 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16
29 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16
30 (cont) WORK INTERVIEWER GEC 2 2014-11-16
31 (cont) WORK INTERVIEWER GEC 2 2014-11-16
32 (cont) WORK INTERVIEWER GEC 2 2014-11-16
33 (cont) SOCIAL & LEISURE ACTIVITIES INTERVIEWER GEC 2 2014-11-16
34 (cont) SOCIAL & LEISURE ACTIVITIES INTERVIEWER GEC 2 2014-11-16
35 (cont) SOCIAL & LEISURE ACTIVITIES INTERVIEWER GEC 2 2014-11-16
36 (cont) FAMILY & FRIENDSHIPS INTERVIEWER GEC 2 2014-11-16
CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
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Row QSBLFL QSSCAT QSEVAL QSEVALID VISITNUM QSDTC
37 (cont) RETURN TO NORMAL LIFE INTERVIEWER GEC 2 2014-11-16
38 (cont) RETURN TO NORMAL LIFE INTERVIEWER GEC 2 2014-11-16
39 (cont) EPILEPSY INTERVIEWER GEC 2 2014-11-16
40 (cont) EPILEPSY INTERVIEWER GEC 2 2014-11-16
41 (cont) OUTCOME FACTOR INTERVIEWER GEC 2 2014-11-16
42 (cont) INTERVIEWER GEC 2 2014-11-16
The respondent value from the CRF data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and
QLABEL are listed below.
Rows 1-23: Subject P0001 from Table QS.XPT had ‘Patient + relative/ friend/ carer’ given as the respondent on the GOSE so QVAL=PATIENT +
RELATIVE/ FRIEND/ CARER is a supplemental qualifier.
Rows 24-42: Subject P0002 from Table QS.XPT had ‘Patient alone’ given as the respondent on the GOSE so QVAL=PATIENT ALONE is a
supplemental qualifier.
suppqs.xpt Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL
1 STUDYX QS P0001 QSSEQ 1 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
2 STUDYX QS P0001 QSSEQ 2 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
3 STUDYX QS P0001 QSSEQ 3 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
4 STUDYX QS P0001 QSSEQ 4 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
5 STUDYX QS P0001 QSSEQ 5 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
6 STUDYX QS P0001 QSSEQ 6 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
7 STUDYX QS P0001 QSSEQ 7 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
8 STUDYX QS P0001 QSSEQ 8 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
9 STUDYX QS P0001 QSSEQ 9 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)
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Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL
10 STUDYX QS P0001 QSSEQ 10 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
11 STUDYX QS P0001 QSSEQ 11 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
12 STUDYX QS P0001 QSSEQ 12 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
13 STUDYX QS P0001 QSSEQ 13 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
14 STUDYX QS P0001 QSSEQ 14 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
15 STUDYX QS P0001 QSSEQ 15 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
16 STUDYX QS P0001 QSSEQ 16 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
17 STUDYX QS P0001 QSSEQ 17 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
18 STUDYX QS P0001 QSSEQ 18 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
19 STUDYX QS P0001 QSSEQ 19 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
20 STUDYX QS P0001 QSSEQ 20 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
21 STUDYX QS P0001 QSSEQ 21 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
22 STUDYX QS P0001 QSSEQ 22 PRIMSRC Primary Source of
Information
PATIENT + RELATIVE/ FRIEND/
CARER CRF
23 STUDYX QS P0001 QSSEQ 23 PRIMSRC Primary Source of
Information PATIENT + RELATIVE/ FRIEND/
CARER CRF
24 STUDYX QS P0002 QSSEQ 1 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
25 STUDYX QS P0002 QSSEQ 2 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
26 STUDYX QS P0002 QSSEQ 26 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
27 STUDYX QS P0002 QSSEQ 27 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
28 STUDYX QS P0002 QSSEQ 28 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
29 STUDYX QS P0002 QSSEQ 29 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
30 STUDYX QS P0002 QSSEQ 30 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
31 STUDYX QS P0002 QSSEQ 31 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
32 STUDYX QS P0002 QSSEQ 32 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
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Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL
33 STUDYX QS P0002 QSSEQ 33 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
34 STUDYX QS P0002 QSSEQ 34 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
35 STUDYX QS P0002 QSSEQ 35 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
36 STUDYX QS P0002 QSSEQ 36 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
37 STUDYX QS P0002 QSSEQ 37 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
38 STUDYX QS P0002 QSSEQ 38 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
39 STUDYX QS P0002 QSSEQ 39 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
40 STUDYX QS P0002 QSSEQ 40 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
41 STUDYX QS P0002 QSSEQ 41 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
42 STUDYX QS P0002 QSSEQ 42 PRIMSRC Primary Source of
Information PATIENT ALONE CRF
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4 SDTM Mapping Strategy
Extended Glasgow Outcome Scale (GOSE) 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, QSSTRESC, and QSSTRESN) should be populated for the
questionnaire.
QSTESTCD=GOSE101 QSTEST= GOSE1-Obey Simple Commands or Say Words
QSORRES QSSTRESC QSSTRESN
No (VS) No (VS)
Yes Y
QSTESTCD=GOSE102A QSTEST= GOSE1-Daily Assistance at Home Essential
QSTESTCD=GOSE102C QSTEST= GOSE1-Assistance at Home Before Injury
QSTESTCD=GOSE103B QSTEST= GOSE1-Shop Without Assist Before Injury
QSTESTCD=GOSE104B QSTEST= GOSE1-Travel Without Assist Before Inj
QSTESTCD=GOSE105A QSTEST= GOSE1-Able to Work to Previous Capacity
QSTESTCD=GOSE105C QSTEST= GOSE1-Working Before Injury
QSTESTCD=GOSE106A QSTEST= GOSE1-Resume Social/Leisure Outside Home
QSTESTCD=GOSE106C QSTEST= GOSE1-Engage Social/Leisure Before Inj
QSTESTCD=GOSE107A QSTEST= GOSE1-Disruptive Psychological Problems
QSTESTCD=GOSE107C QSTEST= GOSE1-Family/Friends Probs Before Injury
QSORRES QSSTRESC QSSTRESN
No N
Yes Y
QSTESTCD=GOSE102B QSTEST= GOSE1-Need Frequent Help at Home
QSORRES QSSTRESC QSSTRESN
No (Upper SD) No (Upper SD)
Yes (Lower SD) Yes (Lower SD)
QSTESTCD=GOSE103A QSTEST= GOSE1-Shop Without Assistance
QSTESTCD=GOSE104A QSTEST= GOSE1-Travel Locally Without Assistance
QSORRES QSSTRESC QSSTRESN
No (Upper SD) No (Upper SD)
Yes Y
QSTESTCD=GOSE105B QSTEST= GOSE1-How Restricted Are They
QSORRES QSSTRESC QSSTRESN
a (Upper MD) a (Upper MD)
b (Lower MD) b (Lower MD)
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QSTESTCD=GOSE106B QSTEST= GOSE1-Extent Social/Leisure Restriction
QSTESTCD=GOSE107B QSTEST= GOSE1-Extent of Disruption
QSORRES QSSTRESC QSSTRESN
a (Lower GR) a (Lower GR)
b (Upper MD) b (Upper MD)
c (Lower MD) c (Lower MD)
QSTESTCD=GOSE108A QSTEST= GOSE1-Other Problems Related to Injury
QSORRES QSSTRESC QSSTRESN
No (Upper GR) No (Upper GR)
Yes (Lower GR) Yes (Lower GR)
QSTESTCD=GOSE109 QSTEST= GOSE1-Since Injury Any Epileptic Fits
QSTESTCD=GOSE110 QSTEST= GOSE1-At Risk of Developing Epilepsy
QSORRES QSSTRESC QSSTRESN
No N
Yes Y
QSTESTCD=GOSE111 QSTEST= GOSE1-Most Important Factor in Outcome
QSORRES QSSTRESC QSSTRESN
Effects of head injury Effects of head injury
Effects of illness or injury to another part of
the body
Effects of illness or injury to another part of
the body
A mixture of these A mixture of these
QSTESTCD=GOSE112 QSTEST= GOSE1-GOSE Overall Score
QSORRES QSSTRESC QSSTRESN
Dead 1 1
Vegetative State (VS) 2 2
Lower Severe Disability (Lower SD) 3 3
Upper Severe Disability (Upper SD) 4 4
Lower Moderate Disability (Lower MD) 5 5
Upper Moderate Disability (Upper MD) 6 6
Lower Good Recovery (Lower GR) 7 7
Upper Good Recovery (Upper GR) 8 8
5 Supplemental Qualifier Name Codes The following table contains an additional standard name codes for use in the Supplemental Qualifiers for
Questionnaires (SUPPQS) special-purpose dataset.
QNAM QLABEL Applicable Domains
PRIMSRC Primary Source of Information QS
End of Document