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CDISC SDTM DAD Questionnaire Supplement (Version 1.0)

© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved June 27, 2013

Disability Assessment for Dementia

(DAD)

Questionnaire Supplement to the Study Data

Tabulation Model Implementation Guide

for Human Clinical Trials

Prepared by

CAMD AD v1.1 Team and the 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

2013-05-21 0.1 Disability Assessment for Dementia (DAD) - Draft

2013-06-27 1.0 Disability Assessment for Dementia (DAD)



Introduction This document describes the CDISC implementation of the Disability Assessment for Dementia

(DAD) questionnaire, a standard questionnaire that is typically used in clinical trials as an

assessment of functional disability used by clinicians. The clinician has a respondent, such as a

family member or caregiver, answer questions about an Alzheimer’s patient’s functionality in

areas of self-care and basic daily living activities. A DAD user guide is available for more

detailed information on the background of the questionnaire including scoring of results.

The DAD 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).

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.

Copyright Status This instrument is copyright approved. CDISC has included the Disability Assessment for

Dementia (DAD) 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)

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.

http://www.cdisc.org/sdtm

http://www.cdisc.org/content2909

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

http://www.cdisc.org/terminology



CDISC acknowledges L. Gauthier and I. Gelinas "Disability Assessment for Dementia (DAD)

(copyright 1994 by L. Gauthier I. Gelinas. All rights reserved.)"for the agreement to include

Disability Assessment for Dementia (DAD) scale in the CDISC data standards.

Further information about the development of the DAD can be found in the article “Development of a

Functional Measure for Persons With Alzheimer’s Disease: The Disability Assessment for

Dementia, Isabelle Gélinas, Louise Gauthier, Maria McIntyre and Serge Gauthier, American

Journal of Occupational Therapy September/October 1999 vol. 53 no. 5 471-481”.

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 Disability Assessment for

Dementia (DAD) questionnaire are listed below.

Disability Assessment for Dementia (DAD) is a questionnaire that clinicians may use to

provide an assessment of functional disability. It consists of 40 items answered “Yes” or

“No” or “N/A”. They are answered by a caregiver or other observer.

These 40 CRF questions are grouped into sub-categories (QSSCAT) as INITIATION,

PLANNING & ORGANIZATION, and EFFECTIVE PERFORMANCE.

The time period of evaluation for the DAD is populated in the QSEVLINT field in ISO

8601 format when the evaluation interval can be precisely described as duration.

Typically, the evaluation interval for DAD is the past 14 days.

The DAD questionnaire is administered through an interview with a caregiver and thus

the evaluator stored in QSEVAL=”relationship value” based on the relationship field on

the CRF. The respondent field on the CRF indicates the specific person providing the

evaluation and is not mapped. The field RATER on the CRF indicates the site rater

filling out the form and is mapped to SUPPQS with QNAM=RATERID,

IDVAR=VISITNUM and IDVARVAL=”visit number”. This provides the capability to

have a different RATER at different visits to be specified.

4. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology.

b. A full list of value sets for qualifier, timing, result and unit fields is provided in

Section 4: SDTM Mapping Strategy.



Example for the Disability Assessment for Dementia (DAD) QS Domain Model

The DAD example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data

for one subject collected at the baseline visit for a DAD questionnaire. The example uses CDISC controlled terminology for

QSTESTCD, QSTEST, and QSCAT. This example is based on a questionnaire with an evaluation interval of the past 14 days.

Rows 1-39: Represent the questions from the DAD form. All original results are represented with preferred terminology in

QSORRES. This result is then transformed into a standard numeric score in QSSTRESN and a character representation

of the standard numeric score in QSSTRESC. The evaluation interval for DAD is the past week, which is stored in

QSEVLINT in ISO format.

Row 40: Shows answer of “N/A”. QSORRES should be “N/A”.

Rows 41-49 Shows the QSSCAT sub-totals and number of applicable items scored.

QS.XPT Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC

1 STUDYX QS P0001 1 DAD0101 DAD01-Decide to Wash DAD INITIATION YES 1

2 STUDYX QS P0001 2 DAD0102 DAD01-Decide to Brush Teeth Dentures DAD INITIATION NO 0

3 STUDYX QS P0001 3 DAD0103 DAD01-Decide to Care For Hair DAD INITIATION NO 0

4 STUDYX QS P0001 4 DAD0104 DAD01-Prepare For Washing Bath

Shower DAD

PLANNING AND

ORGANIZATION YES 1

5 STUDYX QS P0001 5 DAD0105 DAD01-Wash and Dry Body Safely DAD EFFECTIVE PERFORMANCE YES 1

6 STUDYX QS P0001 6 DAD0106 DAD01-Brush Teeth Take Care of

Dentures DAD EFFECTIVE PERFORMANCE NO 0

7 STUDYX QS P0001 7 DAD0107 DAD01-Take Care of Hair DAD EFFECTIVE PERFORMANCE NO 0

8 STUDYX QS P0001 8 DAD0108 DAD01-Decide to Dress DAD INITIATION NO 0

9 STUDYX QS P0001 9 DAD0109 DAD01-Choose Appropriate Clothing DAD PLANNING AND

ORGANIZATION NO 0

10 STUDYX QS P0001 10 DAD0110 DAD01-Dress in Appropriate Order DAD PLANNING AND

ORGANIZATION NO 0

11 STUDYX QS P0001 11 DAD0111 DAD01-Dress Completely DAD EFFECTIVE PERFORMANCE NO 0

12 STUDYX QS P0001 12 DAD0112 DAD01-Undress Completely DAD EFFECTIVE PERFORMANCE NO 0



Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC

13 STUDYX QS P0001 13 DAD0113 DAD01-Use Toilet at Appropriate

Times DAD INITIATION NO 0

14 STUDYX QS P0001 14 DAD0114 DAD01-Use Toilet Without Accidents DAD EFFECTIVE PERFORMANCE NO 0

15 STUDYX QS P0001 15 DAD0115 DAD01-Decide That He/She Needs to

Eat DAD INITIATION YES 1

16 STUDYX QS P0001 16 DAD0116 DAD01-Choose Appropriate Utensils DAD PLANNING AND

ORGANIZATION YES 1

17 STUDYX QS P0001 17 DAD0117 DAD01-Eat at Normal Pace With

Manners DAD EFFECTIVE PERFORMANCE YES 1

18 STUDYX QS P0001 18 DAD0118 DAD01-Decide to Prepare Meal Snack DAD INITIATION YES 1

19 STUDYX QS P0001 19 DAD0119 DAD01-Adequately Plan Light Meal

Snack DAD

PLANNING AND

ORGANIZATION YES 1

20 STUDYX QS P0001 20 DAD0120 DAD01-Prepare or Cook Light Meal

Snack DAD EFFECTIVE PERFORMANCE YES 1

21 STUDYX QS P0001 21 DAD0121 DAD01-Telephone Someone at Suitable

Time DAD INITIATION NO 0

22 STUDYX QS P0001 22 DAD0122 DAD01-Find and Dial Telephone

Number DAD

PLANNING AND

ORGANIZATION NO 0

23 STUDYX QS P0001 23 DAD0123 DAD01-Carry Out Telephone

Conversation DAD EFFECTIVE PERFORMANCE YES 1

24 STUDYX QS P0001 24 DAD0124 DAD01-Write Convey Telephone

Message DAD EFFECTIVE PERFORMANCE NO 0

25 STUDYX QS P0001 25 DAD0125 DAD01-Decide to Go Out DAD INITIATION YES 1

26 STUDYX QS P0001 26 DAD0126 DAD01-Adequately Organize an Outing DAD PLANNING AND

ORGANIZATION NO 0

27 STUDYX QS P0001 27 DAD0127 DAD01-Go Out Without Getting Lost DAD EFFECTIVE PERFORMANCE NO 0

28 STUDYX QS P0001 28 DAD0128 DAD01-Safely Take Transportation DAD EFFECTIVE PERFORMANCE NO 0

29 STUDYX QS P0001 29 DAD0129 DAD01-Return From Store With Items DAD EFFECTIVE PERFORMANCE NO 0

30 STUDYX QS P0001 30 DAD0130 DAD01-Show Interest in Personal

Affairs DAD INITIATION YES 1



Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC

31 STUDYX QS P0001 31 DAD0131 DAD01-Organize Finances to Pay Bills DAD PLANNING AND

ORGANIZATION NO 0

32 STUDYX QS P0001 32 DAD0132 DAD01-Adequately Organize

Correspondence DAD

PLANNING AND

ORGANIZATION YES 1

33 STUDYX QS P0001 33 DAD0133 DAD01-Handle Money Adequately DAD EFFECTIVE PERFORMANCE YES 1

34 STUDYX QS P0001 34 DAD0134 DAD01-Take Medications at Correct

Time DAD INITIATION NO 0

35 STUDYX QS P0001 35 DAD0135 DAD01-Take Medications as Prescribed DAD PLANNING AND

ORGANIZATION NO 0

36 STUDYX QS P0001 36 DAD0136 DAD01-Show Interest in Leisure

Activity DAD INITIATION YES 1

37 STUDYX QS P0001 37 DAD0137 DAD01-Take Interest in Household

Chores DAD INITIATION NO 0

38 STUDYX QS P0001 38 DAD0138 DAD01-Plan Organize Household

Chores DAD

PLANNING AND

ORGANIZATION NO 0

39 STUDYX QS P0001 39 DAD0139 DAD01-Complete Household Chores DAD EFFECTIVE PERFORMANCE YES 1

40 STUDYX QS P0001 40 DAD0140 DAD01-Stay Safely at Home When

Needed DAD EFFECTIVE PERFORMANCE N/A 0

41 STUDYX QS P0001 41 DAD0141 DAD01-Sub-Total Initiation DAD 6 6

42 STUDYX QS P0001 42 DAD0142 DAD01-Initiation Num Applic Items DAD 13 13

43 STUDYX QS P0001 43 DAD0143 DAD01-Sub-Total Planning/ Org DAD 4 4

44 STUDYX QS P0001 44 DAD0144 DAD01-Planning/Org Num Applic

Items DAD 11 11

45 STUDYX QS P0001 45 DAD0145 DAD01-Sub-Total Effective Perform DAD 6 6

46 STUDYX QS P0001 46 DAD0146 DAD01-Effective Perform Num Applic

Items DAD 15 15

47 STUDYX QS P0001 47 DAD0147 DAD01-Total DAD 16 16

48 STUDYX QS P0001 48 DAD0148 DAD01-DAD Total Num Applic Items DAD 39 39

49 STUDYX QS P0001 49 DAD0149 DAD01-Total % DAD 41 41



QS.xpt cont. Row QSSTRESN QSSTRESU QSBLFL QSDRVFL QSEVAL VISITNUM QSDTC QSEVLINT

1 (cont) 1 Y CAREGIVER 1 2012-11-16 -P14D






























Row QSSTRESN QSSTRESU QSBLFL QSDRVFL QSEVAL VISITNUM QSDTC QSEVLINT













41 (cont) 6 Y Y CAREGIVER 1 2012-11-16 -P14D








49 (cont) 41 % Y Y CAREGIVER 1 2012-11-16 -P14D

Supplemental Qualifier for Relationship The following table contains an example for Relationship for use in the Supplemental Qualifiers for Questionnaires (SUPPQS)

special-purpose dataset

STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QEVAL QORIG

STUDYX QS P0001 VISITNUM 1 RATERID Rater Identifier GEC CRF



Section 4: SDTM Mapping Strategy

DAD 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. For all questions, the following scale should

be used.

For all QSTESTCDs

QSORRES QSSTRESC QSSTRESN

YES 1 1

NO 0 0

N/A 0 0

QSSCAT=INITIATION

QSTESTCD QSTEST

DAD0101 DAD01-Decide to Wash

DAD0102 DAD01-Decide to Brush Teeth Dentures

DAD0103 DAD01-Decide to Care For Hair

DAD0108 DAD01-Decide to Dress

DAD0113 DAD01-Use Toilet at Appropriate Times

DAD0115 DAD01-Decide That He/She Needs to Eat

DAD0118 DAD01-Decide to Prepare Meal Snack

DAD0121 DAD01-Telephone Someone at Suitable Time

DAD0125 DAD01-Decide to Go Out

DAD0130 DAD01-Show Interest in Personal Affairs

DAD0134 DAD01-Take Medications at Correct Time

DAD0136 DAD01-Show Interest in Leisure Activity

DAD0137 DAD01-Take Interest in Household Chores



QSSCAT= PLANNING AND ORGANIZATION

QSTESTCD QSTEST

DAD0104 DAD01-Prepare For Washing Bath Shower

DAD0109 DAD01-Choose Appropriate Clothing

DAD0110 DAD01-Dress in Appropriate Order

DAD0116 DAD01-Choose Appropriate Utensils

DAD0119 DAD01-Adequately Plan Light Meal Snack

DAD0122 DAD01-Find and Dial Telephone Number

DAD0126 DAD01-Adequately Organize an Outing

DAD0131 DAD01-Organize Finances to Pay Bills

DAD0132 DAD01-Adequately Organize Correspondence

DAD0135 DAD01-Take Medications as Prescribed

DAD0138 DAD01-Plan Organize Household Chores

QSSCAT= EFFECTIVE PERFORMANCE

QSTESTCD QSTEST

DAD0105 DAD01-Wash and Dry Body Safely

DAD0106 DAD01-Brush Teeth Take Care of Dentures

DAD0107 DAD01-Take Care of Hair

DAD0111 DAD01-Choose Appropriate Utensils

DAD0112 DAD01-Dress Completely

DAD0114 DAD01-Undress Completely

DAD0117 DAD01-Use Toilet Without Accidents

DAD0120 DAD01-Prepare or Cook Light Meal Snack

DAD0123 DAD01-Carry Out Telephone Conversation

DAD0124 DAD01-Write Convey Telephone Message

DAD0127 DAD01-Go Out Without Getting Lost

DAD0128 DAD01-Safely Take Transportation

DAD0129 DAD01-Return From Store With Items



DAD0133 DAD01-Handle Money Adequately

DAD0139 DAD01-Complete Household Chores

DAD0140 DAD01-Complete Household Chores



Section 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

RATERID Rater Identifier QS

End of Document

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