Sheehan Disability Scale

(SDS)
Questionnaire Supplement to the Study Data
Tabulation Model Implementation Guide
for Human Clinical Trials
Prepared by
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

2013-08-28 1.0 Sheehan Disability Scale (SDS) Draft
2013-09-12 1.0 Sheehan Disability Scale (SDS)
 CDISC SDTM SDS Questionnaire Supplement (Version 1.0)

1 Introduction
This document describes the CDISC implementation of the Sheehan Disability Scale (SDS)
questionnaire, a standard questionnaire that is typically used in clinical trials to provide an
assessment of disability related to work, social life, and family life. (https://www.medical-
outcomes.com/index/sds)

The SDS questionnaire 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: (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
CDISC has obtained permission to include the Sheehan Disability Scale (SDS) questionnaire as part
of the CDISC Data Standards. This means that 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. 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.

CDISC has developed this documentation at no cost to the copyright holder or any additional
cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges David V. Sheehan for the agreement to include the Sheehan Disability
Scale (SDS) (Copyright 1983, 2010, 2011 David V. Sheehan. All rights reserved.) in the CDISC
Data Standards.

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 CDISC SDTM SDS Questionnaire Supplement (Version 1.0)

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 Sheehan Disability Scale form:
1. Sheehan Disability Scale (SDS): SDS is an anchored visual analog scale using visual-
spatial, numeric (0-10), and verbal descriptive anchors simultaneously to assess
disability across three domains: work, social life, and family life. The SDS can be
self-administered, administered by a clinician or both independently. It takes 1 to 2
minutes to complete the scale. (https://www.medical-outcomes.com/index/sds)
2. The scale includes a descriptive rating for each numeric point, but there are more
numeric points than descriptions (e.g. 1, 2, and 3 are all associated with “Mildly”). In
cases where the description associated with the number is unique (e.g. “Extremely”
and “10”), QSORRES is populated with the description. In cases where the
description associated with the number is not unique (e.g. “1 Mildly”, “2 Mildly”),
QSORRES is populated with the number, a hyphen, and the description (e.g. “1-
Mildly”, “2-Mildly”). In all cases, QSSTRESC and QSSTRESN are populated with
the numeric response.
3. The rating scale question for WORK/SCHOOL on the CRF includes a check box
indicating that the subject did not work or study in the “Work / School” section of the
scale. QSORRES=CHECKED if the check box is checked. For this section, a response is
required for either the check box or for the scale. Only the record with a response will be
included in SDTM. Rows 2 and 7 in the example below are used to illustrate this
behavior. These rows will not be present in the actual datasets.
4. The time period of evaluation for the SDS is populated in the QSEVLINT field in ISO
8601 format when the evaluation interval can be precisely described as duration. When a
reference to the time period is included in the question, the evaluation interval for SDS is
the past week.
5. The questionnaire rater’s role should be stored in QSEVAL. For SDS, the rater could
be set as the SUBJECT or the INVESTIGATOR.
6. Terminology:
a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology.
b. A full list of value sets for QSORRES, QSSTRESC, and QSSTRESN are
provided in Section 4: SDTM Mapping Strategy.

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3.2 Example for Sheehan Disability Scale QS Domain Model

The SDS example below shows the controlled terminology for QSCAT, QSTEST, and
QSTESTCD and the standard values for QSORRES, QSSTRESC, and QSSTRESN that should
be utilized for this scale.

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 CDISC SDTM SDS (Version 1.0)

Example: Sheehan Disability Scale (SDS)

This example shows data from one subject collected at two visits for an SDS questionnaire. The example uses standard controlled terminology for
QSTESTCD, QSTEST, and QSCAT. This example is based on a questionnaire with an evaluation interval of the past week.

Rows 1-12: Represent the questions from the SDS form. Rows 2 and 7 are for illustrative purposes in order to display the QSTESTCD/QSTEST
values. The QSORRES value is set to XXX to indicate that no value was collected. As described in assumption 3, the actual missing records would
not be created in the QS domain.

QS.XPT
Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SO RRES Q SSTRESC Q SSTRESN
1 ST UDYX QS P0001 1 SDS0101 SDS01-Work / SDS Not at all 0 0
School
2 ST UDYX QS P0001 2 SDS0101A SDS01-No SDS XXX XXX
Work/Study -
Unrelated Disorder
3 ST UDYX QS P0001 3 SDS0102 SDS01-Social Life SDS 2-Mildly 2 2
4 ST UDYX QS P0001 4 SDS0103 SDS01-Family SDS 8-Markedly 8 8
Life/Home
Responsibilities
5 ST UDYX QS P0001 5 SDS0104 SDS01-Days Lost SDS 2 2 2
6 ST UDYX QS P0001 6 SDS0105 SDS01-Days SDS 2 2 2
Underproductive
7 ST UDYX QS P0001 7 SDS0101 SDS01-Work / SDS XXX XXX
School
8 ST UDYX QS P0001 8 SDS0101A SDS01-No SDS CHECKED CHECKED
Work/Study -
Unrelated Disorder
9 ST UDYX QS P0001 9 SDS0102 SDS01-Social Life SDS 5-Moderately 5 5
10 ST UDYX QS P0001 10 SDS0103 SDS01-Family SDS Extremely 10 10
Life/Home
Responsibilities
11 ST UDYX QS P0001 11 SDS0104 SDS01-Days Lost SDS A 0 0 0
12 ST UDYX QS P0001 12 SDS0105 SDS01-Days SDS 1 1 1
Underproductive

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Row Q SBLFL VISITNUM Q SDTC Q SEVLINT

1 (cont) Y 1 2012-11-16
2 (cont) Y 1 2012-11-16 -P1W
3 (cont) Y 1 2012-11-16
4 (cont) Y 1 2012-11-16
5 (cont) Y 1 2012-11-16 -P1W
6 (cont) Y 1 2012-11-16 -P1W
7 (cont) 2 2012-11-23
8 (cont) 2 2012-11-23 -P1W
9 (cont) 2 2012-11-23
10 (cont) 2 2012-11-23
11(cont) 2 2012-11-23 -P1W
12 (cont) 2 2012-11-23 -P1W

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4 SDTM Mapping Strategy

SDS 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=SDS0101 QSTEST=SDS01-Work / School

QSTESTCD=SDS0102 QSTEST=SDS01-Social Life
QSTESTCD=SDS0103 QSTEST=SDS01-Family Life/Home Responsibilities
QSORRES QSSTRESC QSSTRESN
Not at all 0 1
1-Mildly 1 1
2-Mildly 2 2
3-Mildly 3 3
4-Moderately 4 4
5-Moderately 5 5
6-Moderately 6 6
7-Markedly 7 7
8-Markedly 8 8
9-Markedly 9 9
Extremely 10 10

QSTESTCD=SDS0101A QSTEST=SDS01-No Work/Study - Unrelated Disorder

QSORRES QSSTRESC QSSTRESN
CHECKED CHECKED

End of Document

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