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© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1
August 16, 2013
Alzheimer’s Disease Cooperative Study - Activities of Daily Living Inventory - MCI
(ADCS-ADL MCI)
Questionnaire Supplement to the Study Data
Tabulation Model Implementation Guide
for Human Clinical Trials
Prepared by
CAMD ADv1.1 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
2013-05-15 0.1 Alzheimer’s Disease Cooperative Study - Activities of Daily Living Inventory - MCI (ADCS-ADL MCI) (Draft)
2013-08-16 1.0 Alzheimer’s Disease Cooperative Study - Activities of Daily
Living Inventory - MCI (ADCS-ADL MCI)
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2
August 16, 2013
1 Introduction This document describes the CDISC implementation of the Alzheimer’s Disease Cooperative
Study - Activities of Daily Living Inventory - MCI (ADCS-ADL MCI) questionnaire, a standard questionnaire that is typically used in clinical trials to provide an assessment of mild cognitive impairment. Please refer to the Alzheimer’s Disease Cooperative Study web site for further
details on this questionnaire. (http://www.adcs.org/)
The ADCS-ADL MCI 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 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 copyright approved. CDISC has included the Alzheimer’s Disease Cooperative
Study - Activities of Daily Living Inventory - MCI (ADCS-ADL MCI) 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.
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3
August 16, 2013
CDISC acknowledges the Alzheimer's Disease Cooperative Study based on the publication
reference [Activities of Daily Living Inventory (ADCS-ADL), MCI Version Galasko, D., Bennett, D., Sano, M., Ernesto, C., Thomas, R., Grundman, M., Ferris, S., and the ADCS. “An
Inventory to Assess Activities of Daily Living for Clinical Trials in Alzheimer’s Disease.” Alzheimer’s Disease and Associated Disorders, 1997. Volume 11(2): S33-S39.] for the agreement to include the ADCS-ADL MCI Activities of Daily Living Inventory (ADCS-ADL
MCI) scale in the CDISC data standards.
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 ADCS-ADL MCI questionnaire are listed below.
(ADCS-ADL MCI) is a multiple choice questionnaire that clinicians may use to provide an assessment of mild cognitive impairment. It consists of 24 items, each answered
“Yes”, “No” or “Don’t Know”. If the respondent answers “Yes”, there are sub questions that are either answered “Yes” or “No”, rated on a numeric scale (which differs from question to question), or the respondent is asked to choose multiple items from a list.
Only the first eighteen questions are included in the scoring.
1. Some sub questions contain a “Yes/No” answer choice. Please refer to Section 4:
SDTM Mapping Strategy for instructions on how to map these.
2. Questions 17 and 18 have “check all that apply” answer choices. QSORRES = “CHECKED” or “UNCHECKED” and QSSTRESC = “CHECKED” or
“UNCHECKED” and QSSTRESN is always left blank.
3. The time period of evaluation for the ADCS-ADL MCI is populated in the QSEVLINT
field in ISO 8601 format when the evaluation interval can be precisely described as
duration. The evaluation interval for ADCS-ADL MCI, questions 1-23, is the past four
weeks.
4. The questionnaire evaluator should be stored in QSEVAL. For ADCS-ADL MCI, the
evaluator is usually defined as INVESTIGATOR. Additional identifying information to further distinguish the rater in QSEVAL should be stored in QSEVALID. An example is
rater initials.
5. “Don’t Know” answers are scored separately on page 9 of the CRF. The sub-score total
from that worksheet is included as a variable in the QS terminology. The scores for each item on the worksheet are not.
6. If a question is answered “No” or “Don’t Know”, such as questions ADL0301 or ADL0302, the sub-questions (If yes, ask questions…) are not entered into SDTM, since
they are not applicable and were not asked. Exceptions to this are questions ADL0303, ADL0322 and ALD0323, where there are no sub-questions. Please refer to the annotated
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4
August 16, 2013
CRF, and rows 60 and 61 of the example data below to determine how to correctly record these questions.
7. 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.
© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5
August 16, 2013
3.2 Example for Alzheimer’s Disease Cooperative Study - Activities of Daily Living Inventory - MCI (ADCS-ADL MCI) QS Domain
Model
The ADCS-ADL MCI 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 ADCS-ADL MCI 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 four weeks.
Original results are represented with standard results in QSORRES. This result is then transformed into a standard numeric score in QSSTRESN and a standard character representation of the standard numeric score in QSSTRESC. Standardized
results for each question are found in Section 4: STDM Mapping Strategy.
Rows 1-5: Represent the questions from the ADCS-ADL MCI CRF. The qualifying questions (ones without a letter suffix) do not have
a QSSTRESN value, since they are not part of the scoring. The sub-questions have numeric and text values. Row 6: Shows a case where the respondent answered “No” for the qualifying question. For row 6, QSSTRESC is the standardized
result for “No”. QSSTRESN is blank since it is not part of the scoring. QSTESTCD=ADL0303A from the annotated CRF is
not shown because no record is created in SDTM, as based on the “No” response on row 6 Row 7: Shows a case where the respondent answered “Don’t Know” to a qualifying question. QSSTRESN is blank.
QSTESTCD=ADL0304A on the annotated CRF is not shown because no record is created in SDTM, based on the “Don’t Know” response on row 7
Rows 8-39: Represent the questions from the ADCS-ADL MCI CRF. The qualifying questions (ones without a letter suffix) are blank for
QSSTRESN, since they are not part of the scoring. The sub-questions have a numeric and text value. Rows 40-51: This is question 17 from the ADCS-ADL MCI CRF. When Q17 QSORRES = “Yes”, then each appliance question is listed
from the CRF as “CHECHED or “NOT CHECKED”. QSSTRESN is blank for each appliance question. Row 52: This question is related to question 17 on the CRF. QSSTRESC and QSSTRESN contain the appropriate standard result
values.
Row 53: This is question 18 on the CRF. Since the respondent answered “No” to the qualifying question (ADL0318), none of the individual pastimes are recorded. ADL0318A-ADL0318O are not answered since the respondent answered “No” to question
18. QSTESTCD=ADL0318P and ADL0318Q (18a and 18b on the annotated CRF) are not answered in this case either and no record is created in SDTM. If the qualifying question number 18 is answered as “yes”, the result logic would be the same as described for question 17 in rows 40-51 above.
Row 54-59: Represent the general questions 19 to 21 from the ADCS-ADL MCI CRF and not included in any sub-totals. The qualifying questions (ones without a letter suffix) are blank for QSSTRESN. The sub-questions have a numeric and text value.
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
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August 16, 2013
Row 60: Represents the general question 22 from the ADCS-ADL MCI CRF. Row 61: Represents the general question 23 from the ADCS-ADL MCI CRF and shows a case where respondent answered “Don’t
Know” for question 23. QSSTRESN is blank. Row 62-63: Represent question 24 on the CRF. QSSTRESN is blank.
Row 64: Is the total score from the worksheet on page 9 of the CRF-“Total Points for Don’t Know”. Rows 65-72: Represent the sub scores for each page of the questionnaire as indicated on the annotated CRF. Row 73: This is the total score from page 8.
qs.xpt Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SO RRES Q SSTRESC Q SSTRESN
1 STUDYX QS P0001 1 ADL0301 ADL03-Find Personal Belongings ADCS-ADL
MCI Yes Y
2 STUDYX QS P0001 2 ADL0301A ADL03-Find Belongings
Performance
ADCS-ADL
MCI with physical help 1 1
3 STUDYX QS P0001 3 ADL0302 ADL03-Select First Clothes for
the Day
ADCS-ADL
MCI Yes Y
4 STUDYX QS P0001 4 ADL0302A ADL03-Clothes Selection
Performance
ADCS-ADL
MCI with supervision 2 2
5 STUDYX QS P0001 5 ADL0303 ADL03-Usual Dressing
Performance
ADCS-ADL
MCI
Needed physical help only for
buttons, clasps, or shoelaces 2 2
6 STUDYX QS P0001 6 ADL0304 ADL03-Clean Room ADCS-ADL
MCI No N
7 STUDYX QS P0001 7 ADL0305 ADL03-Balance Checkbook ADCS-ADL
MCI Don’t Know Don’t Know
8 STUDYX QS P0001 8 ADL0306 ADL03-Write Things Down
ADCS-ADL
MCI Yes Y
9 STUDYX QS P0001 9 ADL0306A ADL03-Most Complicated
Writing
ADCS-ADL
MCI his/her signature or name 0 0
10 STUDYX QS P0001 10 ADL0307 ADL03-Clean Laundry ADCS-ADL
MCI Yes Y
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
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August 16, 2013
Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SO RRES Q SSTRESC Q SSTRESN
11 STUDYX QS P0001 11 ADL0307A ADL03-Laundry Cleaning
Performance
ADCS-ADL
MCI with supervision 1 1
12 STUDYX QS P0001 12 ADL0308 ADL03-Keep Appointments ADCS-ADL
MCI Yes Y
13 STUDYX QS P0001 13 ADL0308A ADL03-Appointment Awareness ADCS-ADL
MCI
usually remembered the
appointment after verbal
reminders on the day
1 1
14 STUDYX QS P0001 14 ADL0309 ADL03-Use a Telephone ADCS-ADL
MCI Yes Y
15 STUDYX QS P0001 15 ADL0309A ADL03-Highest Telephone Use
Performance
ADCS-ADL
MCI
made calls only to well-
known numbers, without
referring to a directory or list
3 3
16 STUDYX QS P0001 16 ADL0310 ADL03-Make a Meal ADCS-ADL
MCI Yes Y
17 STUDYX QS P0001 17 ADL0310A ADL03-Highest Level of Food
Preparation
ADCS-ADL
MCI
cooked or microwaved food,
with extensive help 2 2
18 STUDYX QS P0001 18 ADL0311 ADL03-Get Around Outside
Home
ADCS-ADL
MCI Yes Y
19 STUDYX QS P0001 19 ADL0311A
ADL03-Get Around Optimal
Performance
ADCS-ADL
MCI
travelled only with physical
help, regardless of the trip 0 0
20 STUDYX QS P0001 20 ADL0312 ADL03-Talk About Current
Events
ADCS-ADL
MCI Yes Y
21 STUDYX QS P0001 21 ADL0312A ADL03-Regional, National,
International
ADCS-ADL
MCI No 0 0
22 STUDYX QS P0001 22 ADL0312B ADL03-Talk About Outside
Events
ADCS-ADL
MCI No 0 0
23 STUDYX QS P0001 23 ADL0312C ADL03-Talk About at Home
Events
ADCS-ADL
MCI Yes 1 1
24 STUDYX QS P0001 24 ADL0312D ADL03-Talk Without Repeating ADCS-ADL
MCI No 0 0
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
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August 16, 2013
Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SO RRES Q SSTRESC Q SSTRESN
25 STUDYX QS P0001 25 ADL0313 ADL03-Read More Than 5
Minutes
ADCS-ADL
MCI Yes Y
26 STUDYX QS P0001 26 ADL0313A ADL03-Select/Ask for Something
to Read
ADCS-ADL
MCI Yes 1 1
27 STUDYX QS P0001 27 ADL0313B ADL03-Talk Within 1 Hour After
Reading
ADCS-ADL
MCI Yes 1 1
28 STUDYX QS P0001 28 ADL0313C ADL03-Talk Within 1 Day After
Reading
ADCS-ADL
MCI Yes 1 1
29 STUDYX QS P0001 29 ADL0314 ADL03-Watch Television ADCS-ADL
MCI Yes Y
30 STUDYX QS P0001 30 ADL0314A ADL03-Select Television
Program
ADCS-ADL
MCI Yes 1 1
31 STUDYX QS P0001 31 ADL0314B ADL03-Talk About TV Content
While Watch
ADCS-ADL
MCI No 0 0
32 STUDYX QS P0001 32 ADL0314C ADL03-Talk About TV Content
Within a Day
ADCS-ADL
MCI Yes 1 1
33 STUDYX QS P0001 33 ADL0315 ADL03-Go Shopping ADCS-ADL
MCI Yes Y
34 STUDYX QS P0001 34 ADL0315A ADL03-Select items Without
Help
ADCS-ADL
MCI No 0 0
35 STUDYX QS P0001 35 ADL0315B ADL03-Pay Items On His/Her
Own
ADCS-ADL
MCI No 0 0
36 STUDYX QS P0001 36 ADL0316 ADL03-Left On His/Her Own ADCS-ADL
MCI Yes Y
37 STUDYX QS P0001 37 ADL0316A ADL03-Left Away From Home
ADCS-ADL
MCI No 0 0
38 STUDYX QS P0001 38 ADL0316B ADL03-Left at Home for 1 Hour
or Longer
ADCS-ADL
MCI No 0 0
39 STUDYX QS P0001 39 ADL0316C ADL03-Left at Home for Less
Than 1 Hour
ADCS-ADL
MCI Yes 1 1
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
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August 16, 2013
Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SO RRES Q SSTRESC Q SSTRESN
40 STUDYX QS P0001 40 ADL0317 ADL03-Use Household
Appliance
ADCS-ADL
MCI Yes Y
41 STUDYX QS P0001 41 ADL0317A ADL03-Appliance: Washer ADCS-ADL
MCI CHECKED CHECKED
42 STUDYX QS P0001 42 ADL0317B ADL03-Appliance: Dryer ADCS-ADL
MCI CHECKED CHECKED
43 STUDYX QS P0001 43 ADL0317C ADL03-Appliance: Vacuum ADCS-ADL
MCI NOT CHECKED
NOT
CHECKED
44 STUDYX QS P0001 44 ADL0317D ADL03-Appliance: Dishwasher ADCS-ADL
MCI NOT CHECKED
NOT
CHECKED
45 STUDYX QS P0001 45 ADL0317E ADL03-Appliance: Power Tools ADCS-ADL
MCI NOT CHECKED
NOT
CHECKED
46 STUDYX QS P0001 46 ADL0317F ADL03-Appliance: Toaster Oven ADCS-ADL
MCI NOT CHECKED
NOT
CHECKED
47 STUDYX QS P0001 47 ADL0317G ADL03-Appliance: Range ADCS-ADL
MCI NOT CHECKED
NOT
CHECKED
48 STUDYX QS P0001 48 ADL0317H ADL03-Appliance: Microwave ADCS-ADL
MCI CHECKED CHECKED
49 STUDYX QS P0001 49 ADL0317I ADL03-Appliance: Food
Processor
ADCS-ADL
MCI NOT CHECKED
NOT
CHECKED
50 STUDYX QS P0001 50 ADL0317J ADL03-Appliance: Other ADCS-ADL
MCI NOT CHECKED
NOT
CHECKED
51 STUDYX QS P0001 51 ADL0317K ADL03-Appliance: Other Specify ADCS-ADL
MCI NOT CHECKED
NOT
CHECKED
52 STUDYX QS P0001 52 ADL0317L
ADL03-Use Common Used
Appliances (q17a)
ADCS-ADL
MCI
Without help, but operated
only on/off controls 3 3
53 STUDYX QS P0001 53 ADL0318 ADL03-Perform Pastime ADCS-ADL
MCI No N
54 STUDYX QS P0001 54 ADL0319 ADL03-Drive Car ADCS-ADL
MCI Yes Y
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
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August 16, 2013
Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SO RRES Q SSTRESC Q SSTRESN
55 STUDYX QS P0001 55 ADL0319A ADL03-Drive Car Optimal
Performance
ADCS-ADL
MCI
drove short distances locally,
only with a passenger who
provided input such as
directions or instructions
1 1
56 STUDYX QS P0001 56 ADL0320 ADL03-Take Medications
Regularly
ADCS-ADL
MCI Yes Y
57 STUDYX QS P0001 57 ADL0320A ADL03-Take Medications
Performance
ADCS-ADL
MCI
Only after frequent verbal
reminders to do so 3 3
58 STUDYX QS P0001 58 ADL0321 ADL03-Complete Complex
Activities
ADCS-ADL
MCI Yes Y
59 STUDYX QS P0001 59 ADL0321A ADL03-Extent Needed
Reminders
ADCS-ADL
MCI
Needed regular reminders or
prompting (daily) 1 1
60 STUDYX QS P0001 60 ADL0322 ADL03-Initiate Complex
Activities
ADCS-ADL
MCI
Needed regular reminders or
prompting (daily) 1 1
61 STUDYX QS P0001 61 ADL0323 ADL03-Time to Complete
Complex Tasks
ADCS-ADL
MCI Don’t Know Don’t Know
62 STUDYX QS P0001 62 ADL0324 ADL03-Extenuating
Circumstances
ADCS-ADL
MCI Yes Y
63 STUDYX QS P0001 63 ADL0324A ADL03-Explain Circumstance ADCS-ADL
MCI
SUBJECT MOVED
RECENTLY
SUBJECT
MOVED
RECENTLY
64 STUDYX QS P0001 64 ADL0325 ADL03-Total Points for 'Don't
Know'
ADCS-ADL
MCI 2 2 2
65 STUDYX QS P0001 65 ADL0326 ADL03-Subscore for Items 1 to 3 ADCS-ADL
MCI 5 5 5
66 STUDYX QS P0001 66 ADL0327 ADL03-Subscore for Items 4 to 7 ADCS-ADL
MCI 1 1 1
67 STUDYX QS P0001 67 ADL0328 ADL03-Subscore for Items 8 to
10
ADCS-ADL
MCI 6 6 6
68 STUDYX QS P0001 68 ADL0329 ADL03-Subscore for Items 11 to
12d
ADCS-ADL
MCI 1 1 1
CDISC SDTM ADCS-ADL MCI Questionnaire Supplement (Version 1.0)
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August 16, 2013
Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SO RRES Q SSTRESC Q SSTRESN
69 STUDYX QS P0001 69 ADL0330 ADL03-Subscore for Items 13 to
14c
ADCS-ADL
MCI 5 5 5
70 STUDYX QS P0001 70 ADL0331 ADL03-Subscore for Items 15 to
16c
ADCS-ADL
MCI 1 1 1
71 STUDYX QS P0001 71 ADL0332 ADL03-Subscore for Item 17 ADCS-ADL
MCI 3 3 3
72 STUDYX QS P0001 72 ADL0333 ADL03-Subscore for Item 18 ADCS-ADL
MCI 0 0 0
73 STUDYX QS P0001 73 ADL0334 ADL03-Total ADCS-ADL Score ADCS-ADL
MCI 22 22 22
qs.xpt cont
Row Q SBLFL Q SEVAL Q SEVALID VISITNUM Q SDTC Q SEVLINT
1 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
2 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
3 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
4 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
5 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
6 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
7 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
8 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
9 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
10 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
11 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
12 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
13 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
14 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
15 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
16 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
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August 16, 2013
Row Q SBLFL Q SEVAL Q SEVALID VISITNUM Q SDTC Q SEVLINT
17 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
18 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
19 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
20 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
21 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
22 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
23 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
24 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
25 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
26 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
27 (cont) Y INVESTIGAT OR GEC 1 2012-11-16 -P4W
28 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
29 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
30 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
31 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
32 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
33 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
34 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
35 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
36 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
37 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
38 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
39 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
40 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
41 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
42 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
43 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
44 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
45 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
46 (cont) Y INVESTIGATOR GEC 1 2012-12-16 -P4W
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August 16, 2013
Row Q SBLFL Q SEVAL Q SEVALID VISITNUM Q SDTC Q SEVLINT
47 (cont) Y INVESTIGATOR GEC 1 2012-12-16 -P4W
48 (cont) Y INVESTIGATOR GEC 1 2012-12-16 -P4W
49 (cont) Y INVESTIGATOR GEC 1 2012-12-16 -P4W
50 (cont) Y INVESTIGATOR GEC 1 2012-12-16 -P4W
51 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
52 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
53 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
54 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
55 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
56 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
57 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
58 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
59 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
60 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
61 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
62 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
63 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
64 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
65 (cont) Y INVESTIGATOR GEC 1 2012-11-16 -P4W
The CRF question, “Information obtained through”, value is populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.
suppqs.xpt STUDYID RDO MAIN USUBJID IDVAR IDVARVAL Q NAM Q LABEL Q VAL Q ORIG Q EVAL STUDYX QS P0001 VISITNUM 1 CONTACT Contact Type Subject visit CRF
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4. SDTM Mapping Strategy
ADCS-ADL MCI 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=ADL0301A QSTEST= ADL03-Find Belongings Performance QSTESTCD=ADL0302A QSTEST= ADL03-Clothes Selection Performance
QSORRES QSSTRESC QSSTRESN Without supervision or help 3 3
With supervision 2 2
with physical help 1 1
QSTESTCD=ADL0304A QSTEST= ADL03- Clean Room Performance
QSTESTCD=ADL0305A QSTEST= ADL03- Balance Checkbook Performance
QSTESTCD=ADL0307A QSTEST= ADL03- Laundry Cleaning Performance
QSORRES QSSTRESC QSSTRESN
Without supervision or help 2 2 With supervision 1 1
with physical help 0 0
QSTESTCD=ADL0303 QSTEST= ADL03-Usual Dressing Performance
QSORRES QSSTRESC QSSTRESN dressed completely without supervision or physical help
4 4
dressed completely with supervision, but without help
3 3
needed physical help only for buttons, clasps, or shoelaces
2 2
needed some help even if clothes needed No fastening or buttoning
1 1
someone else dressed him/her 0 0 Don’t Know
QSTESTCD=ADL0306A QSTEST= ADL03-Most Complicated Writings
QSORRES QSSTRESC QSSTRESN
letters or long notes that other people understood
2 2
1 short notes or messages that other people understood
1 1
0 his/her signature or name 0 0
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QSTESTCD=ADL0308A QSTEST= ADL03-Aware of Appointment Ahead of Time
QSORRES QSSTRESC QSSTRESN
usually remembered without written or verbal reminders
3 3
usually referred to notes, a diary, or calendar
2 2
1usually remembered the appointment after verbal reminders on
1 1
usually did not remember, in spite of verbal reminders on the day
0 0
QSTESTCD=ADL0309A QSTEST= ADL03-Highest Telephone Use Performance
QSTESTCD=ADL0310A QSTEST= ADL03-Highest Level of Food Preparation
QSORRES QSSTRESC QSSTRESN made any call necessary e.g., after looking up numbers in white or yellow pages, or by dialing directory assistance
4 4
made calls only to well-known numbers, without referring to a directory or list
3 3
made calls only to well-known numbers, by using a directory or list
2 2
answered the phone and spoke to callers; did not make calls
1 1
did not answer the phone, but spoke when put on the line
0 0
QSORRES QSSTRESC QSSTRESN cooked or microwaved food, with little or No help
3 3
cooked or microwaved food, with extensive help
2 2
mixed or combined food items for a meal or snack, without cooking or microwaving (e.g. made a sandwich)
1 1
obtained food on his/her own, without mixing or cooking it
0 0
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QSTESTCD=ADL0311A QSTEST= ADL03-Get Around Optimal Performance
QSTESTCD=ADL0312A QSTEST= ADL03-Regional, National, International
QSTESTCD=ADL0312B QSTEST= ADL03-Talk About Outside Events
QSTESTCD=ADL0312C QSTEST= ADL03-Talk About at Home Events QSTESTCD=ADL0312D QSTEST= ADL03-Talk Without Repeating
QSTESTCD=ADL0313A QSTEST= ADL03-Select/Ask for Something to Read
QSTESTCD=ADL0313B QSTEST= ADL03-Talk Within 1 Hour After Reading
QSTESTCD=ADL0313C QSTEST= ADL03-Talk Within 1 Day After Reading
QSTESTCD=ADL0314A QSTEST= ADL03-Select Television Program
QSTESTCD=ADL0314B QSTEST= ADL03-Talk About TV Content While Watch
QSTESTCD=ADL0314C QSTEST= ADL03-Talk About TV Content Within a Day QSTESTCD=ADL0315A QSTEST= ADL03-Select items Without Help
QSTESTCD=ADL0315B QSTEST= ADL03-Pay Items On His/Her Own
QSTESTCD=ADL0316A QSTEST= ADL03-Left Away From Home
QSTESTCD=ADL0316B QSTEST= ADL03-Left at Home for 1 Hour or Longer
QSTESTCD=ADL0316C QSTEST= ADL03-Left at Home for Less Than 1 Hour
QSTESTCD=ADL0317L QSTEST= ADL03-Use Common Used Appliances (q17a)
QSTESTCD=ADL0317A - ADL0317J
QSTESTCD=ADL0318A - ADL0318N
QSORRES QSSTRESC QSSTRESN traveled alone, went at least 1 mile away from home
3 3
traveled alone, but remained within 1 mile of home
2 2
traveled only with a chaperone for supervision regardless of the trip
1 1
traveled only with physical help, regardless of the trip
0 0
QSORRES QSSTRESC QSSTRESN
Yes 1 1
No 0 0
QSORRES QSSTRESC QSSTRESN without help, and operated all necessary controls
4 4
without help, but operated only on/off controls
3 3
with supervision (e.g., instructions), but No physical help
2 2
with physical help 1 1
QSORRES QSSTRESC QSSTRESN CHECKED CHECKED
NOT CHECKED NOT CHECKED
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QSTESTCD=ADL0318P QSTEST= ADL03-Hobbies Needed Help (Q18a)
QSTESTCD=ADL0319A QSTEST= ADL03-Drive Car Optimal Performance
QSTESTCD=ADL0320A QSTEST= ADL03-Take Medications Performance
QSTESTCD=ADL0321A QSTEST= ADL03-Extent Needed Reminders
QSTESTCD=ADL0322 QSTEST= ADL03-Initiate Complex Activities
QSORRES QSSTRESC QSSTRESN No supervision required 3 3
supervision 2 2 help 1 1
QSORRES QSSTRESC QSSTRESN
{S} drove anywhere, without limitation or help 3 3
{S} drove short distances locally, without limitation or help
2 2
{S} drove short distances locally, only with a passenger who provided input such as directions or instructions
1 1
QSORRES QSSTRESC QSSTRESN Independently 4 4
Only after frequent verbal reminders to do so
3 3
Took medications without help if they were set out or arranged for him/her
2 2
Usually or only when someone else gave the medications
1 1
QSORRES QSSTRESC QSSTRESN
Rarely or never needed reminders or prompts
3 3
Sometimes needed reminders or prompts (several times per week)
2 2
Needed regular reminders or prompting (daily)
1 1
QSORRES QSSTRESC QSSTRESN
Rarely or never needed reminders or prompts
3 3
Sometimes needed reminders or prompts (several times per week)
2 2
Needed regular reminders or prompting (daily)
1 1
Don’t Know
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QSTESTCD=ADL0323 QSTEST= ADL03-Time to Complete Complex Tasks
QSORRES QSSTRESC QSSTRESN Normal speed or duration, compared to {S}’s performance over the past few years
3 3
Slower than would have been the case a year or two ago
2 2
Occasionally failed to complete complex tasks, or made errors
1 1
Don’t Know
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5 Supplemental Qualifier Name Codes The following table contains an additional standard name code for use in the Supplemental Qualifiers for
Questionnaires (SUPPQS) special-purpose dataset.
QNAM QLABEL Applicable Domains
CONTACT Contact Type QS
End of Document