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CDISC SDTM GOSE Questionnaire Supplement (Version 1.0)

© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved 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)



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.

http://www.cdisc.org/sdtm

http://www.cdisc.org/content2909

http://www.cdisc.org/bylaws-and-policies

http://www.cdisc.org/terminology



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.



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)


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).



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



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



5 (cont) INDEPENDENCE OUTSIDE THE HOME INTERVIEWER GEC 2 2014-11-16







9 (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



15 (cont) FAMILY & FRIENDSHIPS INTERVIEWER GEC 2 2014-11-16



18 (cont) RETURN TO NORMAL LIFE INTERVIEWER GEC 2 2014-11-16


20 (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




















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


Information

PATIENT + RELATIVE/ FRIEND/

CARER CRF



CARER CRF


Information


CARER CRF


Information


CARER CRF


Information


CARER CRF


Information


CARER CRF


Information


CARER CRF


Information


CARER CRF



Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL


Information


CARER CRF



CARER CRF


Information


CARER CRF



CARER CRF


Information


CARER CRF



CARER CRF


Information


CARER CRF



CARER CRF


Information


CARER CRF



CARER CRF


Information


CARER CRF



CARER CRF


Information


CARER CRF



CARER CRF


Information PATIENT ALONE CRF



















Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL























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


No N

Yes Y

QSTESTCD=GOSE102B QSTEST= GOSE1-Need Frequent Help at Home


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


No (Upper SD) No (Upper SD)

Yes Y

QSTESTCD=GOSE105B QSTEST= GOSE1-How Restricted Are They


a (Upper MD) a (Upper MD)

b (Lower MD) b (Lower MD)



QSTESTCD=GOSE106B QSTEST= GOSE1-Extent Social/Leisure Restriction

QSTESTCD=GOSE107B QSTEST= GOSE1-Extent of Disruption


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


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


No N

Yes Y

QSTESTCD=GOSE111 QSTEST= GOSE1-Most Important Factor in Outcome


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


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

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