Disability Assessment for Dementia (DAD)

Transcription

1 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 Disability Assessment for Dementia (DAD) - Draft Disability Assessment for Dementia (DAD) 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1

2 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: ( 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: ( The CDISC Intellectual Property Policy can be found on the CDISC web site at: ( 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. ( 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 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2

3 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 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 &, 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 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

4 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: Row 40: Rows 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. Shows answer of N/A. QSORRES should be N/A. 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 P DAD0101 DAD01-Decide to Wash DAD INITIATION YES 1 2 STUDYX QS P DAD0102 DAD01-Decide to Brush Teeth Dentures DAD INITIATION 3 STUDYX QS P DAD0103 DAD01-Decide to Care For Hair DAD INITIATION 4 STUDYX QS P DAD0104 DAD01-Prepare For Washing Bath DAD Shower YES 1 5 STUDYX QS P DAD0105 DAD01-Wash and Dry Body Safely DAD EFFECTIVE PERFORMANCE YES 1 6 STUDYX QS P DAD0106 DAD01-Brush Teeth Take Care of Dentures DAD EFFECTIVE PERFORMANCE 7 STUDYX QS P DAD0107 DAD01-Take Care of Hair DAD EFFECTIVE PERFORMANCE 8 STUDYX QS P DAD0108 DAD01-Decide to Dress DAD INITIATION 9 STUDYX QS P DAD0109 DAD01-Choose Appropriate Clothing DAD 10 STUDYX QS P DAD0110 DAD01-Dress in Appropriate Order DAD 11 STUDYX QS P DAD0111 DAD01-Dress Completely DAD EFFECTIVE PERFORMANCE 12 STUDYX QS P DAD0112 DAD01-Undress Completely DAD EFFECTIVE PERFORMANCE 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC 13 STUDYX QS P DAD0113 DAD01-Use Toilet at Appropriate Times DAD INITIATION 14 STUDYX QS P DAD0114 DAD01-Use Toilet Without Accidents DAD EFFECTIVE PERFORMANCE 15 STUDYX QS P DAD0115 DAD01-Decide That He/She Needs to Eat DAD INITIATION YES 1 16 STUDYX QS P DAD0116 DAD01-Choose Appropriate Utensils DAD YES 1 17 STUDYX QS P DAD0117 DAD01-Eat at Normal Pace With Manners DAD EFFECTIVE PERFORMANCE YES 1 18 STUDYX QS P DAD0118 DAD01-Decide to Prepare Meal Snack DAD INITIATION YES 1 19 STUDYX QS P DAD0119 DAD01-Adequately Plan Light Meal DAD Snack YES 1 20 STUDYX QS P DAD0120 DAD01-Prepare or Cook Light Meal Snack DAD EFFECTIVE PERFORMANCE YES 1 21 STUDYX QS P DAD0121 DAD01-Telephone Someone at Suitable Time DAD INITIATION 22 STUDYX QS P DAD0122 DAD01-Find and Dial Telephone DAD Number 23 STUDYX QS P DAD0123 DAD01-Carry Out Telephone Conversation DAD EFFECTIVE PERFORMANCE YES 1 24 STUDYX QS P DAD0124 DAD01-Write Convey Telephone Message DAD EFFECTIVE PERFORMANCE 25 STUDYX QS P DAD0125 DAD01-Decide to Go Out DAD INITIATION YES 1 26 STUDYX QS P DAD0126 DAD01-Adequately Organize an Outing DAD 27 STUDYX QS P DAD0127 DAD01-Go Out Without Getting Lost DAD EFFECTIVE PERFORMANCE 28 STUDYX QS P DAD0128 DAD01-Safely Take Transportation DAD EFFECTIVE PERFORMANCE 29 STUDYX QS P DAD0129 DAD01-Return From Store With Items DAD EFFECTIVE PERFORMANCE 30 STUDYX QS P DAD0130 DAD01-Show Interest in Personal Affairs DAD INITIATION YES Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

6 Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC 31 STUDYX QS P DAD0131 DAD01-Organize Finances to Pay Bills DAD 32 STUDYX QS P DAD0132 DAD01-Adequately Organize DAD Correspondence YES 1 33 STUDYX QS P DAD0133 DAD01-Handle Money Adequately DAD EFFECTIVE PERFORMANCE YES 1 34 STUDYX QS P DAD0134 DAD01-Take Medications at Correct Time DAD INITIATION 35 STUDYX QS P DAD0135 DAD01-Take Medications as Prescribed DAD 36 STUDYX QS P DAD0136 DAD01-Show Interest in Leisure Activity DAD INITIATION YES 1 37 STUDYX QS P DAD0137 DAD01-Take Interest in Household Chores DAD INITIATION 38 STUDYX QS P DAD0138 DAD01-Plan Organize Household DAD Chores 39 STUDYX QS P DAD0139 DAD01-Complete Household Chores DAD EFFECTIVE PERFORMANCE YES 1 40 STUDYX QS P DAD0140 DAD01-Stay Safely at Home When Needed DAD EFFECTIVE PERFORMANCE N/A 0 41 STUDYX QS P DAD0141 DAD01-Sub-Total Initiation DAD STUDYX QS P DAD0142 DAD01-Initiation Num Applic Items DAD STUDYX QS P DAD0143 DAD01-Sub-Total Planning/ Org DAD STUDYX QS P DAD0144 DAD01-Planning/Org Num Applic Items DAD STUDYX QS P DAD0145 DAD01-Sub-Total Effective Perform DAD STUDYX QS P DAD0146 DAD01-Effective Perform Num Applic Items DAD STUDYX QS P DAD0147 DAD01-Total DAD STUDYX QS P DAD0148 DAD01-DAD Total Num Applic Items DAD STUDYX QS P DAD0149 DAD01-Total % DAD Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

7 QS.xpt cont. Row QSSTRESN QSSTRESU QSBLFL QSDRVFL QSEVAL VISITNUM QSDTC QSEVLINT 1 (cont) 1 Y CAREGIVER P14D 2 (cont) 0 Y CAREGIVER P14D 3 (cont) 0 Y CAREGIVER P14D 4 (cont) 1 Y CAREGIVER P14D 5 (cont) 1 Y CAREGIVER P14D 6 (cont) 0 Y CAREGIVER P14D 7 (cont) 0 Y CAREGIVER P14D 8 (cont) 0 Y CAREGIVER P14D 9 (cont) 0 Y CAREGIVER P14D 10 (cont) 0 Y CAREGIVER P14D 11 (cont) 0 Y CAREGIVER P14D 12 (cont) 0 Y CAREGIVER P14D 13 (cont) 0 Y CAREGIVER P14D 14 (cont) 0 Y CAREGIVER P14D 15 (cont) 1 Y CAREGIVER P14D 16 (cont) 1 Y CAREGIVER P14D 17 (cont) 1 Y CAREGIVER P14D 18 (cont) 1 Y CAREGIVER P14D 19 (cont) 1 Y CAREGIVER P14D 20 (cont) 1 Y CAREGIVER P14D 21 (cont) 0 Y CAREGIVER P14D 22 (cont) 0 Y CAREGIVER P14D 23 (cont) 1 Y CAREGIVER P14D 24 (cont) 0 Y CAREGIVER P14D 25 (cont) 1 Y CAREGIVER P14D 26 (cont) 0 Y CAREGIVER P14D 27 (cont) 0 Y CAREGIVER P14D 28 (cont) 0 Y CAREGIVER P14D 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7

8 Row QSSTRESN QSSTRESU QSBLFL QSDRVFL QSEVAL VISITNUM QSDTC QSEVLINT 29 (cont) 0 Y CAREGIVER P14D 30 (cont) 1 Y CAREGIVER P14D 31 (cont) 0 Y CAREGIVER P14D 32 (cont) 1 Y CAREGIVER P14D 33 (cont) 1 Y CAREGIVER P14D 34 (cont) 0 Y CAREGIVER P14D 35 (cont) 0 Y CAREGIVER P14D 36 (cont) 1 Y CAREGIVER P14D 37 (cont) 0 Y CAREGIVER P14D 38 (cont) 0 Y CAREGIVER P14D 39 (cont) 1 Y CAREGIVER P14D 40 (cont) 0 Y CAREGIVER P14D 41 (cont) 6 Y Y CAREGIVER P14D 42 (cont) 13 Y Y CAREGIVER P14D 43 (cont) 4 Y Y CAREGIVER P14D 44 (cont) 11 Y Y CAREGIVER P14D 45 (cont) 6 Y Y CAREGIVER P14D 46 (cont) 15 Y Y CAREGIVER P14D 47 (cont) 16 Y Y CAREGIVER P14D 48 (cont) 39 Y Y CAREGIVER P14D 49 (cont) 41 % Y Y CAREGIVER 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 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8

9 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 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 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9

10 QSSCAT= QSTESTCD DAD0104 DAD0109 DAD0110 DAD0116 DAD0119 DAD0122 DAD0126 DAD0131 DAD0132 DAD0135 DAD0138 QSTEST DAD01-Prepare For Washing Bath Shower DAD01-Choose Appropriate Clothing DAD01-Dress in Appropriate Order DAD01-Choose Appropriate Utensils DAD01-Adequately Plan Light Meal Snack DAD01-Find and Dial Telephone Number DAD01-Adequately Organize an Outing DAD01-Organize Finances to Pay Bills DAD01-Adequately Organize Correspondence DAD01-Take Medications as Prescribed DAD01-Plan Organize Household Chores QSSCAT= EFFECTIVE PERFORMANCE QSTESTCD DAD0105 DAD0106 DAD0107 DAD0111 DAD0112 DAD0114 DAD0117 DAD0120 DAD0123 DAD0124 DAD0127 DAD0128 DAD0129 QSTEST DAD01-Wash and Dry Body Safely DAD01-Brush Teeth Take Care of Dentures DAD01-Take Care of Hair DAD01-Choose Appropriate Utensils DAD01-Dress Completely DAD01-Undress Completely DAD01-Use Toilet Without Accidents DAD01-Prepare or Cook Light Meal Snack DAD01-Carry Out Telephone Conversation DAD01-Write Convey Telephone Message DAD01-Go Out Without Getting Lost DAD01-Safely Take Transportation DAD01-Return From Store With Items 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 10

11 DAD0133 DAD0139 DAD0140 DAD01-Handle Money Adequately DAD01-Complete Household Chores DAD01-Complete Household Chores 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 11

12 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 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 12