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CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )

© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved

ADAS-Cog Questionnaire Supplement to the Study Data

Tabulation Model Implementation Guide

Prepared by the

Coalition Against Major Diseases (CAMD)

Notes to Readers This implementation guide follows version 3.1.2 (V3.1.2) of the CDISC Submission Data Standards and domain models.

Revision History

Date Version Summary of Changes 2011-09-09 1.0 Draft Alzheimer’s Disease Assessment Scale-

Cognitive (ADAS-Cog) Questionnaire 2011-12-27 1.0 Alzheimer’s Disease Assessment Scale-

Cognitive (ADAS-Cog) Questionnaire release 2012-01-26 1.0 Alzheimer’s Disease Assessment Scale-

Cognitive (ADAS-Cog) Questionnaire release revised with inclusion of copyright appendix

Note: Please see 1570HAppendix F for Representations and Warranties, Limitations of Liability, and Disclaimers.


Page 2 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011

CONTENTS

6 DOMAIN MODELS BASED ON THE GENERAL OBSERVATION CL ASSES ............. 3

6.3 FINDINGS ......................................................................................................................................................... 3

6.3.5 Questionnaire — QS Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog) ..................... 3

6.3.5.1 Assumptions for Questionnaire Domain Model .................................................................................... 3 6.3.5.2 Examples for Alzheimer ‘s Disease ASSESSMENT SCALE Questionnaire Domain Model ............... 4

APPENDICES ............................................................................................................... 13

Appendix 2: Mapping Strategy for SDTM Variables .............................................................................................. 14

Appendix 3: SUPPLEMENTAL Qualifiers Name Codes ........................................................................................ 20

Appendix F: Representations and Warranties, Limitations of Liability, and Disclaimers ...................................... 21


© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3 January 26, 2011

6 Domain Models Based on the General Observation Classes

6.3 FINDINGS

6.3.5 QUESTIONNAIRE — QS ALZHEIMER’S DISEASE ASSESS MENT SCALE – COGNITIVE (ADAS-COG)

See SDTMIG for QS domain table.

The documentation for this questionnaire is located on the CDISC website in the Members Only Section. The link is: http://www.cdisc.org/contentmgr/showdetails.php/id/2909. All questionnaire documentation is being stored together in a separate location because many questionnaires are utilized across many different disease areas. The CDISC Questionnaire Terminology Team is in the process of assessing copyright issues and developing controlled terminology for additional questionnaires. This site will be updated on a regular basis with new questionnaires. .

CDISC acknowledges Dr. Richard Mohs for his agreement to include the ADAS-Cog scale in the CDISC data standards. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64.

6.3.5.1 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 Alzheimer’s disease Assessment Scale – Cognitive. 1. Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog): ADAS-Cog is a standard clinical scale used in Alzheimer’s disease studies. ADAS-Cog scale has been implemented in a number of different methods. The most common implementation is to collect a subset of the 15 summary questions. A certified reviewer provides the scores based on a worksheet which contains all the detailed information recorded in the sub-items. In this approach the sub-item scores are not recorded. The certified reviewer enters the summary scores on the CRF/eCRF. In this case QSDRVFL is NULL. Another approach is to collect the detailed results which include individual sub-items that are used to derive the summary questions. This includes the results of individual trials of specific questions within the ADAS-Cog scale. Summary scores are derived by the sponsor via the detailed questions. In this case QSDRVFL is set to Y for the derived summary record.



The ADAS-Cog example below shows the correct terminology for QSCAT, QSSCAT, QSTEST, QSTESTCD and QSORRES that should be utilized for this scale. Values for QSORRES are for prospective data collection. Sponsors mapping legacy data may retain legacy values for QSORRES.

2. The ADAS-Cog scale collects the reason why specific questions were not completed. The sponsor specifc terminology for the reason the question was not answered are condensed to be either ”Cognitive reasons” or ”Non-Cognitive reasons” as part of the ADAS-Cog data standard. The following table indicates how the QSSTAT and QSREASND fields are populated when the detailed questions are captured and the summary questions are derived.

Based on SDTM rules for these fields, the QSORRES field is blank when QSSTAT=Y or a result is derived (SDTMIG page 47). In the ADAS-Cog scale, when the summary question is “NOT DONE” for “Cognitive reasons”, the derived score is populated with the worse value (.ex “5”) as follows: QSORRES=NULL QSSTRESC=5 QSSTRESN=5 QSDRVFL=Y QSSTAT=NULL QSREASND=NULL. If the NOT DONE reason is “Non-Cognitive reasons”, a missing value (.ex “NULL”) is derived as follows: QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=Y QSSTAT=NULL QSREASND=NULL. This logic indicates that it is not the derivation that is “NOT DONE”; but it the underlying detailed questions used as the source data for the derivation that were “NOT DONE”. Those detail records would be marked as NOT DONE as follows: QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=NULL QSSTAT=NOT DONE QSREASND=”Cognitive reasons” or “Non-Cognitive reasons”. The interpretation of these derived summary question results is based on the detailed question results. For derived summary questions with QSSTRESN=5 or NULL, the interpretation of the not done result is based on the QSSTAT and QSREASND values of the detailed questions results. When the ADAS-Cog data is collected by a certified reviewer, who enters the summary question results, the population of QSSTAT and QSREASND is handled as follows QSORRES=NULL QSSTRESC=5 QSSTRESN=5 QSDRVFL=NULL QSSTAT=NOT DONE QSREASND=Cognitive reasons or QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=NULL QSSTAT=NOT DONE QSREASND=Non-Cognitive reasons. 3. QS ADAS-Cog specific mapping strategy for the following fields is listed in Appendix 1.

a. QSTPT, QSTPTNUM, QSORRES, QSSTRESC and QSSTRESN

6.3.5.2 EXAMPLES FOR ALZHEIMER ‘S DISEASE ASSESSMEN T SCALE QUESTIONNAIRE DOMAIN MODEL

Example 1: Alzheimer’s disease Assessment Scale –Cognitive (ADAS-Cog)



This example shows data from two subjects collected at one visit for an ADAS-Cog questionnaire with the detailed questions collected and the the summary question derived. The example uses standard controlled terminology for QSSPID, QSTESTCD, QSTEST, QSCAT and QSSCAT for the ADAS-Cog scale. Summary rows are shaded and detailed rows are not shaded. In order to show the concepts and for ease of use in review not all of the detailed rows are shown; these rows have “…” in them. For example, rows 4-11 are represented by one row and use the “…” notation. In these rows, STUDYID, DOMAIN, USUBJID, QSCAT, and QSSCAT do not change with regards to row 3. However, QSSEQ, QSSPID, QSTESTCD, and QSTEST with “…” all increment by 1 following the same naming convention as the previous value. QSORRES and QSTRESC would be populated with the actual data. The variables STUDYID=STUDYX, DOMAIN=QS and QSSTRESN are not shown in the example due to page width limitations. Rows 1, 35, 53, 59, 70, 76, 82, 91, 167-172, 176: Represent the 15 possible summary questions from the ADAS-Cog Form. All original results are represented with the

standard terminology in QSORRES. This result is then transformed into a Standard Numeric score from 0-5 in QSSTRESN, which is then also copied to a standard character value in QSSTRESC. All summary scores can either be entered by a certified evaluator or they can be derived via the detailed questions for each summary score. When derived, QSDRVLFL is set to “Y”.

Rows 2-12, 13-23, 24-34: Represent the 3 possible “Word Recall” trials. Rows 2, 13 and 24 represent the individual trial score with the 10 rows after each of these questions representing the individual words recalled either as correct or incorrect. Notice that QSTPTNUM and QSTPT are used to distinguish each of the three possible trials being asked on the same date where no time was collected. For more information on time points, see SDTMIG V3.1.2, Section 4.1.4.10.

Rows 35-52: Represent the “Naming Objects and Fingers” summary and detailed questions. Row 35 is the summary score for the detailed questions 36-52 on each object or finger.

Rows 53-58: Represent the “Commands” summary and detailed questions. Row 53 is the summary score for the detailed questions 54-58 on each command.

Rows 59-69: Represent the “Delayed Word Recall” summary and detailed questions. Row 59 is the summary score for the detailed questions 60-69 on each word presented to the subject for recall.

Rows 70-75: Represent the “Constructional Praxis” summary and detailed questions. Row 70 is the summary score for the detailed questions 71-75 on each “Constructional Praxis” object.

Rows 76-81: Represent the “Ideation Praxis” summary and detailed questions. Row 76 is the summary score for the detailed questions 77-81 on each Constructional Praxis object.

Rows 82-90: Represent the “Orientation summary” and detailed questions. Row 82 is the summary score for the detailed questions 83-90 on each Orientation location.

Rows 91-116, 117-141, 142-166: Represent the 3 possible “Word Recognition” trials. Rows 92, 117 and 142 represent the individual trial scores with each of

the 24 rows after each of these questions representing the individual words recognized either as correct or incorrect. Notice that QSTPTNUM and QSTPT are used to distinguish each of the three possible trials being asked on the same date where no time was collected. For more information on time points, see SDTMIG V3.1.2, Section 4.1.4.10.

Row 167: Represents the “Remembering Test Instructions” QSTEST name. Row 168: Represents the “Spoken Language Ability” QSTEST name. Row 169: Represents the “Word Finding Difficulty in Spont Speech” QSTEST name. Row 170: Represents the “Comprehension” QSTEST name. Row 171: Represents the “Concentration/Distractibility” QSTEST name.



Rows 172-175: Represent the “Number Cancellation” summary and detailed QSTEST names. Row 172 is the summary score for the detailed questions 173-175 on each “Number Cancellation” question.

Rows 176-178: Represent the “Executive Function Maze” summary and detailed questions. Row 176 is the summary score for the detailed questions 177-178 on each “Executive Function Maze” question

Rows 179-191 Represents the use of the NOT DONE status for Cognitive reasons for subject 2324-P0002 for the Word Recall detail and summary questions.

Rows 192-200 Represents the use of the NOT DONE status for Cognitive reasons for subject 2324-P0002 for the Naming Objects and Fingers detail and summary questions.

qs.xpt Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM

1 2324-P0001 1 01 ADCRL Word Recall ADAS-COG WORD

RECALL SUMMARY

2 2 Y

2 2324-P0001 2 01T1 ADCRLT01 Word Recall

Trial 1 ADAS-COG

WORD RECALL DETAIL

2 Words Not Recalled

2 Y

Trial 1 1

3 2324-P0001 3 01T1W01 ADCRLW01 Word Recall:

Word [1] ADAS-COG

WORD RECALL DETAIL

RECALLED RECALLED

Trial 1 1

… 2324-P0001 … … … … ADAS-COG WORD

RECALL DETAIL

… …

Trial 1 1


Word [10] ADAS-COG

WORD RECALL DETAIL

NOT RECALLED

NOT RECALLED

Trial 1 1


Trial2 ADAS-COG

WORD RECALL DETAIL


2 Y

Trial 2 2


Word [1] ADAS-COG

WORD RECALL DETAIL

RECALLED RECALLED

Trial 2 2

… 2324-P0001 … … … … ADAS-COG WORD

RECALL DETAIL

… …

Trial 2 2


Word [10] ADAS-COG

WORD RECALL DETAIL

NOT RECALLED

NOT RECALLED

Trial 2 2


Trial 3 ADAS-COG

WORD RECALL DETAIL


2 Y

Trial 3 3


Word [1] ADAS-COG

WORD RECALL DETAIL

RECALLED RECALLED

Trial 3 3

… 2324-P0001 … … … … ADAS-COG WORD

RECALL DETAIL

… …

Trial 3 3



Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM


Word [10] ADAS-COG

WORD RECALL DETAIL

NOT RECALLED

NOT RECALLED

Trial 3 3

35 2324-P0001 35 02 ADCOF Naming Objects

and Fingers ADAS-COG

NAMING OBJECTS AND

FINGERS SUMMARY

0-2 items incorrect

0 Y

36 2324-P0001 36 02A ADCOFO01 Naming Objects and Fingers: 1

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

CORRECT CORRECT

… 2324-P0001 … … … … … … … … … …

47 2324-P0001 47 02L ADCOFO12 Naming Objects and Fingers: 12

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

CORRECT CORRECT

48 2324-P0001 48 02M ADCOFF01 Naming Objects

and Fingers: Thumb

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

CORRECT CORRECT

49 2324-P0001 49 02N ADCOFF02 Naming Objects

and Fingers: Pointer

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

CORRECT CORRECT

50 2324-P0001 50 02O ADCOFF03 Naming Objects

and Fingers: Middle

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

CORRECT CORRECT

51 2324-P0001 51 02P ADCOFF04 Naming Objects

and Fingers: Ring

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

INCORRECT INCORRECT

52 2324-P0001 52 02Q ADCOFF05 Naming Objects

and Fingers: Pinky

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

INCORRECT INCORRECT

53 2324-P0001 53 03 ADCCMD Commands ADAS-COG COMMANDS SUMMARY

5 Commands Correct

0 Y

54 2324-P0001 54 03A ADCCMD01 Commands: Fist ADAS-COG COMMANDS

DETAIL CORRECT CORRECT

55 2324-P0001 55 03B ADCCMD02 Commands:

Ceiling ADAS-COG

COMMANDS DETAIL

CORRECT CORRECT

56 2324-P0001 56 03C ADCCMD03 Commands:

Pencil ADAS-COG

COMMANDS DETAIL

CORRECT CORRECT

57 2324-P0001 57 03D ADCCMD04 Commands:

Watch ADAS-COG

COMMANDS DETAIL

CORRECT CORRECT

58 2324-P0001 58 03E ADCCMD05 Commands:

Shoulder ADAS-COG

COMMANDS DETAIL

CORRECT CORRECT




59 2324-P0001 59 04 ADCDRL Delayed Word

Recall ADAS-COG

DELAYED WORD

RECALL SUMMARY


10 Y

60 2324-P0001 60 0401 ADCDRL01 Delayed Word

Recall: Word [1] ADAS-COG

DELAYED WORD

RECALL DETAIL

INCORRECT INCORRECT

… 2324-P0001 … … … … … … … … … …

69 2324-P0001 69 0410 ADCDRL10 Delayed Word Recall: Word

[10] ADAS-COG

DELAYED WORD

RECALL DETAIL

INCORRECT INCORRECT

70 2324-P0001 70 05 ADCCP Constructional

Praxis ADAS-COG

CONSTRUCTIONAL PRAXIS SUMMARY

1 form drawn incorrectly

1 Y

71 2324-P0001 71 05A ADCCP01 Constructional Praxis: Circle

ADAS-COG CONSTRUCTIO

NAL PRAXIS DETAIL

INCORRECT INCORRECT

72 2324-P0001 72 05B ADCCP02 Constructional

Praxis: 2 Rectangles


NAL PRAXIS DETAIL

CORRECT CORRECT

73 2324-P0001 73 05C ADCCP03 Constructional

Praxis: Diamond ADAS-COG

CONSTRUCTIONAL PRAXIS


74 2324-P0001 74 05D ADCCP04 Constructional Praxis: Cube


NAL PRAXIS DETAIL

CORRECT CORRECT

75 2324-P0001 75 05E ADCCPS Attempt to Draw ADAS-COG CONSTRUCTIO

NAL PRAXIS DETAIL

76 2324-P0001 76 06 ADCIP Ideational Praxis ADAS-COG IDEATIONAL

PRAXIS SUMMARY

Difficulty to perform 1 task

1 Y

77 2324-P0001 77 06A ADCIP01 Ideational

Praxis: Fold ADAS-COG

IDEATIONAL PRAXIS DETAIL

INCORRECT INCORRECT

78 2324-P0001 78 06B ADCIP02 Ideational

Praxis: Insert ADAS-COG


CORRECT CORRECT

79 2324-P0001 79 06C ADCIP03 Ideational

Praxis: Seal ADAS-COG


CORRECT CORRECT

80 2324-P0001 80 06D ADCIP04 Ideational

Praxis: Address ADAS-COG


CORRECT CORRECT

81 2324-P0001 81 06E ADCIP05 Ideational

Praxis: Stamp ADAS-COG

IDEATIONAL PRAXIS

CORRECT CORRECT



Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM DETAIL

82 2324-P0001 82 07 ADCOR Orientation ADAS-COG ORIENTATION

SUMMARY 2 Items

Incorrect 2 Y

83 2324-P0001 83 07A ADCOR01 Orientation: Full

Name ADAS-COG

ORIENTATION DETAIL

INCORRECT INCORRECT

84 2324-P0001 84 07B ADCOR02 Orientation:

Month ADAS-COG

ORIENTATION DETAIL

INCORRECT INCORRECT

85 2324-P0001 85 07C ADCOR03 Orientation:

Date ADAS-COG

ORIENTATION DETAIL

CORRECT CORRECT

86 2324-P0001 86 07D ADCOR04 Orientation:

Year ADAS-COG

ORIENTATION DETAIL

CORRECT CORRECT

87 2324-P0001 87 07E ADCOR05 Orientation: Day

of Week ADAS-COG

ORIENTATION DETAIL

CORRECT CORRECT

88 2324-P0001 88 07F ADCOR06 Orientation:

Season ADAS-COG

ORIENTATION DETAIL

CORRECT CORRECT

89 2324-P0001 89 07G ADCOR07 Orientation:

Place ADAS-COG

ORIENTATION DETAIL

CORRECT CORRECT

90 2324-P0001 90 07H ADCOR08 Orientation:

Time ADAS-COG

ORIENTATION DETAIL

CORRECT CORRECT

91 2324-P0001 91 08 ADCRG Word

Recognition ADAS-COG

WORD RECOGNITION

SUMMARY 2 2 Y

92 2324-P0001 92 08T1 ADCRGT01 Word

Recognition Trial 1

ADAS-COG WORD

RECOGNITION DETAIL

2 Words Incorrect

2

Trial 1 1

93 2324-P0001 93 08T1W01 ADCRGW01 Word

Recognition: Word [1]

ADAS-COG WORD

RECOGNITION DETAIL

INCORRECT INCORRECT

Trial 1 1

… 2324-P0001 … … … … … … … … … …

116 2324-P0001 116 08T1W24 ADCRGW24 Word


ADAS-COG WORD

RECOGNITION DETAIL

CORRECT CORRECT

Trial 1 1

117 2324-P0001 117 08T2 ADCRGT02 Word

Recognition Trial 2

ADAS-COG WORD

RECOGNITION DETAIL

2 Words Incorrect

2

Trial 2 2

118 2324-P0001 118 08T2W01 ADCRGW01 Word


ADAS-COG WORD

RECOGNITION DETAIL

INCORRECT INCORRECT

Trial 2 2

… 2324-P0001 … … … … … … … … … …

141 2324-P0001 141 08T2W24 ADCRGW24 Word


ADAS-COG WORD

RECOGNITION DETAIL

CORRECT CORRECT

Trial 2 2

142 2324-P0001 142 08T3 ADCRGT03 Word

Recognition Trial 3

ADAS-COG WORD

RECOGNITION DETAIL

2 Words Incorrect

2

Trial 3 3

143 2324-P0001 143 08T3W01 ADCRGW01 Word


ADAS-COG WORD

RECOGNITION DETAIL

INCORRECT INCORRECT

Trial 3 3



Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM … 2324-P0001 … … … … … … … … … …

166 2324-P0001 166 08T3W24 ADCRGW24 Word


ADAS-COG WORD

RECOGNITION DETAIL

CORRECT CORRECT

Trial 3 3

167 2324-P0001 167 09 ADCRI Remembering

Test Instructions ADAS-COG

DEGREE OF IMPAIRMENT

No impairment; patient never needs extra reminders of instructions

0

168 2324-P0001 168 10 ADCSL Spoken

Language Ability

ADAS-COG DEGREE OF

IMPAIRMENT

Very mild; one instance

of understandabil

ity

1

169 2324-P0001 169 11 ADCDIF Word Finding Difficulty in Spont Speech

ADAS-COG DEGREE OF

IMPAIRMENT

Mild; noticeable

circumlocution or synonym substitution

2

170 2324-P0001 170 12 ADCCMP Comprehension ADAS-COG DEGREE OF

IMPAIRMENT

No impairment;

patient understands

0

171 2324-P0001 171 13 ADCCON Concentration/D

istractibility ADAS-COG

DEGREE OF IMPAIRMENT

Very mild; one instance

of poor concentration

1

172 2324-P0001 172 14 ADCNC Number

Cancellation ADAS-COG

NUMBER CANCELLATION SUMMARY

18-23 Correct *

2* Y

173 2324-P0001 173 14A ADCNC01 Number

Cancellation: Correct

ADAS-COG NUMBER

CANCELLATION DETAIL

18 18

174 2324-P0001 174 14B ADCNC02 Number

Cancellation: Errors

ADAS-COG NUMBER

CANCELLATION DETAIL

0 0

175 2324-P0001 175 14C ADCNC03 Number

Cancellation: Remind

ADAS-COG NUMBER

CANCELLATION DETAIL

0 0

176 2324-P0001 176 15 ADCMZ Executive

Function maze ADAS-COG

EXECUTIVE FUNCTION

MAZE SUMMARY

* * Y

177 2324-P0001 177 15A ADCMZ01 Executive

Function maze: Errors

ADAS-COG EXECUTIVE FUNCTION

MAZE DETAIL 2 2

178 2324-P0001 178 15B ADCMZ02 Executive

Function maze: ADAS-COG

EXECUTIVE FUNCTION

42 PT42S



Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM Time MAZE DETAIL

179 2324-P0002 1 01 ADCRL Word Recall ADAS-COG WORD

RECALL SUMMARY

5 Y


Trial 1 ADAS-COG

WORD RECALL DETAIL

5 Y Trial 1 1


Word [1] ADAS-COG

WORD RECALL DETAIL

NOT

DONE Cognitive Reasons

Trial 1 1

182 2324-P0002 4 … … … ADAS-COG WORD

RECALL DETAIL

… … … … … Trial 1 1


Word [10] ADAS-COG

WORD RECALL DETAIL

NOT


Trial 1 1


Trial 2 ADAS-COG

WORD RECALL DETAIL

5 Y Trial 2 2


Word [1] ADAS-COG

WORD RECALL DETAIL

NOT


Trial 2 2

186 2324-P0002 8 … … … ADAS-COG WORD

RECALL DETAIL

… … … … … Trial 2 2


Word [10] ADAS-COG

WORD RECALL DETAIL

NOT


Trial 2 2


Trial 3 ADAS-COG

WORD RECALL DETAIL

5 Y Trial 3 3


Word [1] ADAS-COG

WORD RECALL DETAIL

NOT


Trial 3 3

190 2324-P0002 12 … … … ADAS-COG WORD

RECALL DETAIL

… … … … … Trial 3 3


Word [10] ADAS-COG

WORD RECALL DETAIL

NOT


Trial 3 3

192 2324-P0002 14 02 ADCOF Naming Objects

and Fingers ADAS-COG

NAMING OBJECTS AND

FINGERS SUMMARY

Y

193 2324-P0002 15 02A ADCOFO01 Naming Objects and Fingers: 1

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

NOT

DONE

Non-Cognitive Reasons




194 2324-P0002 16 … … … ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

… … … … …

195 2324-P0002 17 02L ADCOFO12 Naming Objects and Fingers: 12

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

NOT

DONE


196 2324-P0002 18 02M ADCOFF01 Naming Objects

and Fingers: Thumb

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

NOT

DONE


197 2324-P0002 19 02N ADCOFF02 Naming Objects

and Fingers: Pointer

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

NOT

DONE


198 2324-P0002 20 02O ADCOFF03 Naming Objects

and Fingers: Middle

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

NOT

DONE


199 2324-P0002 21 02P ADCOFF04 Naming Objects

and Fingers: Ring

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

NOT

DONE


200 2324-P0002 22 02Q ADCOFF05 Naming Objects

and Fingers: Pinky

ADAS-COG

NAMING OBJECTS AND

FINGERS DETAIL

NOT

DONE


*Values for QSORRES and QSTRESC for Number Cancellation Summary and Executive Function Maze Summary results will be populated pending publication of an accepted algorithm by the Alzheimer’s Disease Cooperative Study (ADCS).



Appendices

APPENDIX 1: QUESTIONNAIRE COPYRIGHT STATUS

CDISC has obtained permission to include the ADAS-Cog questionnaire as part of CDISC Data Standards. This means that CDISC developed QSTESTCD and QSTEST for each question based on the actual question text on the questionnaire. The instrument itself was not changed. 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 copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder. CDISC acknowledges Dr. Richard Mohs for his agreement to include the ADAS-Cog scale in the CDISC data standards. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. The author’s consent ensures that the data captured using this instrument will be done so in a standardized manner thereby facilitating collection, database storage, reporting and regulatory review of that data. CDISC wants to emphasize that the existing copyright status as well as the existing procedures for licensing fees and using the instrument will remain exactly as they have been. Please follow the instrument owners own mechanisms for permissions and licenses if you have a need to use this questionnaire.



APPENDIX 2: MAPPING STRATEGY FOR SDTM VARIABLES

QS ADAS-Cog specific mapping strategy : QSTPTNUM and QSTPT QSTPTNUM QSTPT 1 Trial 1 2 Trial 2 3 Trial 3

QSTEST= Word Recall Trial 1, Word Recall Trial 2, Word Recall Trial 3 QSORRES QSSTRESC QSSTRESN

0 Words Not Recalled 0 0










10 Words Not Recalled 10 10 QSSCAT=WORD RECALL DETAIL QSTEST=Word Recall: Word 1 to Word Recall: Word 10

QSTEST QSSCAT QSORRES QSSTRESC Word Recall: Word [1] WORD RECALL DETAIL RECALLED RECALLED Word Recall: Word [1] WORD RECALL DETAIL NOT RECALLED NOT RECALLED

… WORD RECALL DETAIL … … Word Recall: Word [10] WORD RECALL DETAIL RECALLED RECALLED Word Recall: Word [10] WORD RECALL DETAIL NOT RECALLED NOT RECALLED QSTEST= Naming Objects and Fingers QSORRES QSSTRESC QSSTRESN

0-2 items incorrect 0 0






QSSCAT= NAMING OBJECTS AND FINGERS DETAIL



QSTEST=Word Recall: Word 1 to Word Recall: Word 10 QSTEST QSSCAT QSORRES QSSTRESC

Naming Objects and Fingers: 1 NAMING OBJECTS AND FINGERS



DETAIL INCORRECT INCORRECT

… NAMING OBJECTS AND FINGERS

DETAIL … …





Naming Objects and Fingers: Thumb

NAMING OBJECTS AND FINGERS DETAIL

CORRECT CORRECT

Naming Objects and Fingers: Thumb


INCORRECT INCORRECT

Naming Objects and Fingers: Pointer


CORRECT CORRECT

Naming Objects and Fingers: Pointer


INCORRECT INCORRECT

Naming Objects and Fingers: Middle


CORRECT CORRECT

Naming Objects and Fingers: Middle


INCORRECT INCORRECT

Naming Objects and Fingers: Ring NAMING OBJECTS AND FINGERS


Naming Objects and Fingers: Ring NAMING OBJECTS AND FINGERS


Naming Objects and Fingers: Pinky


CORRECT CORRECT

Naming Objects and Fingers: Pinky


INCORRECT INCORRECT

QSTEST= Commands QSORRES QSSTRESC QSSTRESN

5 Commands Correct 0 0





All Commands Incorrect 5 5

QSSCAT= COMMANDS DETAIL QSTEST= Commands: Fist to Commands: Shoulder Word 10

QSTEST QSSCAT QSORRES QSSTRESC Commands: Fist COMMANDS DETAIL CORRECT CORRECT



QSTEST QSSCAT QSORRES QSSTRESC Commands: Fist COMMANDS DETAIL INCORRECT INCORRECT

… COMMANDS DETAIL … … Commands: Shoulder COMMANDS DETAIL CORRECT CORRECT Commands: Shoulder COMMANDS DETAIL INCORRECT INCORRECT QSTEST= Delayed Word Recall QSORRES QSSTRESC QSSTRESN












QSSCAT= DELAYED WORD RECALL DETAIL QSTEST= Delayed Word Recall: Word [1] to Delayed Word Recall: Word [10]

QSTEST QSSCAT QSORRES QSSTRESC Delayed Word Recall: Word [1] DELAYED WORD RECALL DETAIL CORRECT CORRECT Delayed Word Recall: Word [1] DELAYED WORD RECALL DETAIL INCORRECT INCORRECT

… DELAYED WORD RECALL DETAIL … … Delayed Word Recall: Word [10] DELAYED WORD RECALL DETAIL CORRECT CORRECT Delayed Word Recall: Word [10] DELAYED WORD RECALL DETAIL INCORRECT INCORRECT

QSTEST= Constructional Praxis QSORRES QSSTRESC QSSTRESN

All four drawings correct 0 0

1 form drawn incorrectly 1 1

2 forms drawn incorrectly 2 2



No figures drawn;scribbles;parts of forms;words instead of forms 5 5 QSSCAT= CONSTRUCTIONAL PRAXIS DETAIL QSTEST= Constructional Praxis: Circle to Attempt Draw

QSTEST QSSCAT QSORRES QSSTRESC



QSTEST QSSCAT QSORRES QSSTRESC Constructional Praxis: Circle

CONSTRUCTIONAL PRAXIS DETAIL

CORRECT CORRECT

Constructional Praxis: Circle


INCORRECT INCORRECT

… CONSTRUCTIONAL

PRAXIS DETAIL … …

Constructional Praxis: Cube


CORRECT CORRECT

Constructional Praxis: Cube


INCORRECT INCORRECT

Attempt to Draw CONSTRUCTIONAL PRAXIS DETAIL

Attempt to Draw CONSTRUCTIONAL

PRAXIS DETAIL NONE: Attempted but drew

no forms correctly NONE: Attempted but drew

no forms correctly

QSTEST= Ideational Praxis QSORRES QSSTRESC QSSTRESN

All tasks completed successfully 0 0

Difficulty to perform 1 task 1 1

Difficulty to perform 2 tasks 2 2



Difficulty to perform 5 tasks 5 5 QSSCAT= IDEATIONAL PRAXIS DETAIL QSTEST= Ideational Praxis: Fold to Ideational Praxis: Stamp

QSTEST QSSCAT QSORRES QSSTRESC Ideational Praxis: Fold IDEATIONAL PRAXIS DETAIL CORRECT CORRECT Ideational Praxis: Fold IDEATIONAL PRAXIS DETAIL INCORRECT INCORRECT

… IDEATIONAL PRAXIS DETAIL … … Ideational Praxis: Stamp IDEATIONAL PRAXIS DETAIL CORRECT CORRECT Ideational Praxis: Stamp IDEATIONAL PRAXIS DETAIL INCORRECT INCORRECT

QSTEST= Orientation QSORRES QSSTRESC QSSTRESN

0 Items Incorrect 0 0











QSSCAT= ORIENTATION DETAIL QSTEST= Orientation: Full Name to Orientation: Time

QSTEST QSSCAT QSORRES QSSTRESC Orientation: Full Name ORIENTATION DETAIL CORRECT CORRECT Orientation: Full Name ORIENTATION DETAIL INCORRECT INCORRECT

… ORIENTATION DETAIL … … Orientation: Time ORIENTATION DETAIL CORRECT CORRECT Orientation: Time ORIENTATION DETAIL INCORRECT INCORRECT

QSTEST= Word Recognition Trial 1, Word Recognition Trial 2, Word Recognition Trial 3 QSORRES QSSTRESC QSSTRESN

0 Words Incorrect 0 0












12-24 Words Incorrect 12 12 QSSCAT= WORD RECOGNITION DETAIL QSTEST= Word Recognition: Word [1] to Word Recognition: Word [24]

QSTEST QSSCAT QSORRES QSSTRESC Word Recognition: Word [1] WORD RECOGNITION DETAIL CORRECT CORRECT Word Recognition: Word [1] WORD RECOGNITION DETAIL INCORRECT INCORRECT

… WORD RECOGNITION DETAIL … … Word Recognition: Word [24] WORD RECOGNITION DETAIL CORRECT CORRECT Word Recognition: Word [24] WORD RECOGNITION DETAIL INCORRECT INCORRECT QSTEST= Remembering Test Instructions QSORRES QSSTRESC QSSTRESN

No impairment; patient never needs extra reminders of instructions 0 0

Very mild; forgets once 1 1

Mild; must be reminded 2 times 2 2

Moderate; must be reminded 3 or 4 times 3 3

Moderately severe; must be reminded 5 or 6 times 4 4

Severe; must be reminded 7 or more times 5 5



QSTEST= Spoken Language Ability QSORRES QSSTRESC QSSTRESN

No impairment; patient speaks clearly and/or is understandable 0 0

Very mild; one instance of lack of understandability 1 1

Mild; patient has difficulty < 25% of time 2 2

Moderate; patient has difficulty 25-50% of time 3 3

Moderately severe; patient has difficulty >50% of time 4 4

Severe; one or two word utterances; fluent, but empty speech; mute 5 5

QSTEST= Word Finding Difficulty in Spont Speech QSORRES QSSTRESC QSSTRESN

No evidence of word-finding difficulty in spontaneous speech 0 0

Very mild; one or two instances, not clinically significant 1 1

Mild; noticeable circumlocution or synonym substitution 2 2

Moderate; loss of words with compensation on occasion 3 3

Moderately severe; frequent loss of words without compensation 4 4 Severe; near total loss of content words; speech sounds empty, one or two word utterances 5 5

QSTEST= Comprehension QSORRES QSSTRESC QSSTRESN

No impairment; patient understands 0 0

Very mild; one or two instances of misunderstanding 1 1

Mild; 3-5 instances of misunderstanding 2 2

Moderate; requires several repetitions and rephrasings 3 3 Moderately severe; patient only occasionally responds correctly, i.e., yes/no questions 4 4 Severe; patient rarely responds to questions appropriately, not to property of speech 5 5

QSTEST= Concentration/Distractibility QSORRES QSSTRESC QSSTRESN

None; no evidence of concentration or distractibility 0 0

Very mild; one instance of poor concentration 1 1 Mild; 2-3 instances of poor concentration or distractibility; signs of restlessness and inattentiveness 2 2

Moderate; 4-5 instances during interview 3 3 Moderately severe; poor concentration/distractibility throughout much of the interview 4 4 Severe; extreme difficulty in concentration and extremely distractible, unable to complete tasks 5 5



QSTEST= Number Cancellation QSORRES QSSTRESC QSSTRESN

>=31 Correct 0 0

24-30 Correct 1 1

18-23 Correct 2 2

12-17 Correct 3 3

6-11 Correct 4 4

0-5 Correct 5 5

QSTEST= Executive Function maze QSORRES QSSTRESC QSSTRESN

0-30 sec and 0-1 Errors 0 0





>= 240 sec or >=2 Errors 5 5

APPENDIX 3: SUPPLEMENTAL QUALIFIERS NAME CODES

The following table contains an additional standard name code for use in the Supplemental Qualifiers (SUPP--) special-purpose datasets. There are no SUPPQUAL fields related to the ADAS-Cog questionnaire. See SDTMIG Appendix C5 for other supplemental qualifier name codes. QNAM QLABEL Applicable Domains



APPENDIX F: REPRESENTATIONS AND WARRANTIES, LIMITA TIONS OF LIABILITY, AND DISCLAIMERS

CDISC Patent Disclaimers It is possible that implementation of and compliance with this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be responsible for identifying patent claims for which a license may be required in order to implement this standard or for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its attention. Representations and Warranties Each Participant in the development of this standard shall be deemed to represent, warrant, and covenant, at the time of a Contribution by such Participant (or by its Representative), that to the best of its knowledge and ability: (a) it holds or has the right to grant all relevant licenses to any of its Contributions in all jurisdictions or territories in which it holds relevant intellectual property rights; (b) there are no limits to the Participant’s ability to make the grants, acknowledgments, and agreements herein; and (c) the Contribution does not subject any Contribution, Draft Standard, Final Standard, or implementations thereof, in whole or in part, to licensing obligations with additional restrictions or requirements inconsistent with those set forth in this Policy, or that would require any such Contribution, Final Standard, or implementation, in whole or in part, to be either: (i) disclosed or distributed in source code form; (ii) licensed for the purpose of making derivative works (other than as set forth in Section 4.2 of the CDISC Intellectual Property Policy (“the Policy”)); or (iii) distributed at no charge, except as set forth in Sections 3, 5.1, and 4.2 of the Policy. If a Participant has knowledge that a Contribution made by any Participant or any other party may subject any Contribution, Draft Standard, Final Standard, or implementation, in whole or in part, to one or more of the licensing obligations listed in Section 9.3, such Participant shall give prompt notice of the same to the CDISC President who shall promptly notify all Participants. No Other Warranties/Disclaimers. ALL PARTICIPANTS ACKNOWLEDGE THAT, EXCEPT AS PROVIDED UNDER SECTION 9.3 OF THE CDISC INTELLECTUAL PROPERTY POLICY, ALL DRAFT STANDARDS AND FINAL STANDARDS, AND ALL CONTRIBUTIONS TO FINAL STANDARDS AND DRAFT STANDARDS, ARE PROVIDED “AS IS” WITH NO WARRANTIES WHATSOEVER, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, AND THE PARTICIPANTS, REPRESENTATIVES, THE CDISC PRESIDENT, THE CDISC BOARD OF DIRECTORS, AND CDISC EXPRESSLY DISCLAIM ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, FITNESS FOR ANY PARTICULAR OR INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF ANY PROPOSAL, FINAL STANDARDS OR DRAFT STANDARDS, OR CONTRIBUTION. Limitation of Liability IN NO EVENT WILL CDISC OR ANY OF ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED TO, THE CDISC BOARD OF DIRECTORS, THE CDISC PRESIDENT, CDISC STAFF, AND CDISC MEMBERS) BE LIABLE TO ANY OTHER PERSON OR ENTITY FOR ANY LOSS OF PROFITS, LOSS OF USE, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, WHETHER UNDER CONTRACT, TORT, WARRANTY, OR OTHERWISE, ARISING IN ANY WAY OUT OF THIS POLICY OR ANY RELATED AGREEMENT, WHETHER OR NOT SUCH PARTY HAD ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. Note: The CDISC Intellectual Property Policy can be found at http://www.cdisc.org/about/bylaws_pdfs/CDISCIPPolicy-FINAL.pdf.

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ADAS-Cog Questionnaire Supplement to the Study Data ...portal.cdisc.org/Questionnaire Documentation/Alzheimer's Disease... · CDISC SDTM ADAS-Cog Questionnaire Supplement (Version