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QS=QUESTIONNAIRES
Center:
Subject Initials
VISIT
QSDTC
Examiner Initials
Examination Date
M C
Month
QSEVALID
QSORRES when
QSTESTCD=ADL0301
Yes
Dont
No Know
Day
Year
Subject visit
Telephone call
1
2
QSEVLINT=-P4W
1. In the past 4 weeks, did {S} usually manage to find his/her personal
belongings at home?
If yes, which best describes how he/she usually performed:
QSSTRESC,QSSTRESN
with supervision
QSORRES when
QSTESTCD=ADL0302
2. In the past 4 weeks, did {S} select his/her first set of clothes for the day?
If yes, which best describes his/her usual performance:
3
with supervision
QSORRES when
QSTESTCD=ADL0303
7007.01.010 10/98
Subject Initials
M C
QSORRES when
QSTESTCD=ADL0304
Yes
Dont
No Know
4. In the past 4 weeks, did {S} clean a living-, sitting-, or family room?
If yes, which best describes how he/she usually performed:
QSORRES when
QSTESTCD=ADL0305
with supervision
5. In the past 4 weeks, did {S} balance his/her checkbook or a credit card
statement?
If yes, which best describes how he/she usually performed:
QSORRES when
QSTESTCD=ADL0306
with supervision
QSORRES when
QSTESTCD=ADL0307
7007.01.010 10/98
Subject Initials
M C
QSORRES when
QSTESTCD=ADL0308
Yes
Dont
No Know
8. In the past 4 weeks, did {S} keep appointments or meetings with other
people, such as relatives, a doctor, the hairdresser, etc.?
If yes, which best describes his/her awareness of the meeting ahead of time:
3
QSORRES when
QSTESTCD=ADL0309
QSORRES when
QSTESTCD=ADL0310
answered the phone and spoke to callers; did not make calls
did not answer the phone, but spoke when put on the line
QSORRES when QSTESTCD=ADL0309A
10. In the past 4 weeks, did {S} make him/herself a meal or snack at home?
If yes, which best describes his/her highest level of food preparation:
3
7007.01.010 10/98
Subject Initials
M C
QSORRES when
QSTESTCD=ADL0311
Yes
Dont
No Know
11. In the past 4 weeks, did {S} get around (or travel) outside of his/her home?
If yes, which best describes his/her optimal performance:
QSORRES when
QSTESTCD=ADL0312
12. In the past 4 weeks, did {S} talk about current events? (This means events or
incidents that occurred during the past month.)
If yes, ask questions 12a, 12b, 12c and 12d :
12a) Did {S} talk about regional, national, or international events
(including sports)?
1
Yes
12b) Did {S} talk about events outside home involving family, friends, or
neighbors?
1
Yes
No
12c) Did {S} talk about events that occurred at home that he/she
took part in or watched?
1
Yes
No
Yes
7007.01.010 10/98
Yes
Subject Initials
M C
Dont
No Know
13. In the past 4 weeks, did {S} read a magazine, newspaper or book for more
than 5 minutes at a time?
If yes, ask questions 13a, 13b and 13c:
13a) Did {S} usually select or ask for something to read?
1
Yes
No
Yes
No
Yes
No
Yes
14b) Did {S} usually talk about the content of a program while watching
it?
1
Yes
14c) Did {S} talk about the content of a program within a day (24 hours)
after watching it?
1
Yes
QSORRES
QSTESTCD=ADL0330
YELLOWwhen
- INVESTIGATOR
'S COPY
PINK- CLINICAL MONITOR'S COPY
41
7007.01.010 10/98
Subject Initials
M C
QSORRES when
QSTESTCD=ADL0315
Yes
Dont
No Know
15. In the past 4 weeks, did {S} ever go shopping at a store?
If yes, ask questions 15a and 15b:
15a) Did {S} usually select correct items without supervision or help?
1
Yes
No
QSORRES when
QSTESTCD=ADL0316
Yes
No
16. In the past 4 weeks, was {S} ever left on his/her own?
If yes, ask questions 16a, 16b and 16c:
16a) Was {S} left away from home, for 15 minutes or longer, during
the day?
1
Yes
No
Yes
No
Yes
No
7007.01.010 10/98
Subject Initials
M C
QSORRES when
QSTESTCD=ADL0317
Yes
Dont
No Know
17. In the past 4 weeks, did {S} use a household appliance to do chores?
(This does not include a TV.)
QSTESTCD=ADL0317B
If yes, ask about all of the following, and check those that apply:
QSORRES="CHECKED" or "NOT CHECKED"
QSTESTCD=ADL0317A
QSTESTCD=ADL0317D
washer
dryer
vacuum QSTESTCD=ADL0317C
dishwasher
power tool(s)
toaster oven
range
microwave
food processor
QSTESTCD=ADL0317I
other _____________________________
QSTESTCD=ADL0317J
QSTESTCD=ADL0317E
QSTESTCD=ADL0317K
If yes, ask question 17a:
QSTESTCD=ADL0317F
QSTESTCD=ADL0317H
QSTESTCD=ADL0317G
7007.01.010 10/98
Subject Initials
M C
QSORRES when
QSTESTCD=ADL0318
Yes
Dont
No Know
18. In the past 4 weeks, did {S} perform a pastime, hobby or game?
If yes, ask about all of the following, check all that apply:
QSTESTCD=ADL0318C
QSTESTCD=ADL0318A
QSTESTCD=ADL0318B
bingo
crosswords
art QSTESTCD=ADL0318D
QSTESTCD=ADL0318E
QSTESTCD=ADL0318H
musical instrument
knitting
sewingQSTESTCD=ADL0318G
reading
gardening
golf QSTESTCD=ADL0318J
QSTESTCD=ADL0318K
tennis
workshop
fishingQSTESTCD=ADL0318M
QSTESTCD=ADL0318N
other _____________________________
QSTESTCD=ADL0318O
QSTESTCD=ADL0318F
Note: Walking does NOT count as a hobby/pastime for this scale.
QSTESTCD=ADL0318I
If yes, ask questions 18a and 18b:
QSTESTCD=ADL0318L
18a) Did {S} require supervision, or help, to perform any of
these hobbies?
3
no supervision required
supervision
18b) List any hobby(ies) that the subject has lost the ability to perform:
QSORRES when QSTESTCD=ADL0318Q
______________________________________________
______________________________________________
______________________________________________
7007.01.010 10/98
Subject Initials
M C
Were any questions (1-18) answered Dont Know?
1
2
WORKSHEET
INSTRUCTIONS:
Only for specific questions in 1-18
which were answered Dont Know:
Enter the value from the points
column in the corresponding Dont
Know box for that question.
For example, if question 1 was
answered Dont Know then write
3 in the Dont Know box for
question 1.
Only fill in boxes which correspond
to Dont Know answers.
10
11
12
13
14
15
16
17
18
3
Total Points for
Dont Know
7007.01.010 10/98
Subject Initials
M C
Instrumental Activities of Daily Living
(Do not include these questions in the Total Score)
QSORRES when
QSTESTCD=ADL0319
Yes
Dont
No Know
19. In the past 4 weeks, did {S} drive a car ?
If yes, which best describes his/her optimal performance:
3
{S} drove short distances locally, only with a passenger who provided
input such as directions or instructions
QSORRES when QSTESTCD=ADL0319A
QSORRES when
QSTESTCD=ADL0320
20. During the past 4 weeks, did {S} take his/her medications regularly ?
If yes, was this:
4
Independently
QSORRES when
QSTESTCD=ADL0321
21. During the past 4 weeks, did {S} usually carry through complex or
time-consuming activities to completion ?
If yes, which best describes extent to which he/she needed reminders:
3
7007.01.010 10/98
Subject Initials
M C
Yes
Dont
No Know
22. During the past 4 weeks, to what extent did {S} initiate complex daily activities
or projects (e.g., hobbies, travel) ? (check one)
QSORRES when
QSTESTCD=ADL0322
23. During the past 4 weeks, how long did it usually take {S} to complete complex or time-consuming tasks or activities ? (check one)
QSORRES when
QSTESTCD=ADL0323
Slower than would have been the case a year or two ago
QSORRES when
QSTESTCD=ADL0324
_____________________________________________________
REMINDER: After completing all of the questions, please go back to pages
8 and 9 of this ADL exam to complete the scoring for questions 1-18.
7007.01.010 10/98
General Remarks
ADL
Standardizing independently,
with supervision and with help
55
ADL
5.
Balance checkbook/credit
card statement: if the subject
gives this task to someone
else, they will score no (0)
throughout the trial. If he/she
always balances the
checkbook/statement with
help, they do have room to
decline; he/she may lose the
ability to have meaningful
input into this task as their
cognition declines
6.
7.
8.
Keep appointments or
meetings: evaluates memory
ability. If the subject
sometimes uses memory
aids (notes, calendar, etc.),
and sometimes not, then
choice between the highest
and second highest level
should depend on the usual
pattern of behavior.
1.
2.
3.
4.
56
9.
ADL
57
The next group of questions are new and targeted at MCI subjects. Their data will be entered but
should not be tallied into the total ADCS MCI-ADL Score.
ADL
58
Douglas Galasko, *David Bennett, t Mary Sano, Chris Emesto, Ronald Thomas,
Michael Grundman, :j:Steven Ferris, and the Alzheimer's Disease Cooperative Study
Department of Neurosciences (Neurology), University of California, San Diego, California; *Rush Alzheimer's Disease Center
and Department of Neurological Sciences, Rush-Presbyterian-St. Lukes Medical Center, Chicago, Illinois; tDepartment of
Neurology, Columbia University and the Sergievsky Center, New York, New York; and :j:Departmentof Psychiatry, New York
University Medical Center, New York, New York, u.S.A.
D. GALASKO ET AL.
S34
cognitive test scores or even from tests of specific cognitive domains which ADL are likely to be impaired or
how severe the impairment will be (Loewenstein et aI.,
1992). The amount of cognitive change needed to produce a change in ADL performance is unknown.
ADL evaluation for clinical trials is an understudied
area. Most ADL scales were developed for general geriatric assessment and to help determine the need for
services, and focus on basic activities such as walking,
feeding, and toileting (Katz et aI., 1963; Lawton et aI.,
1969). A few scales, such as those of Blessed (Blessed et
aI., 1968), Lawton (Lawton et aI., 1969), Pfeffer (Pfeffer
et aI., 1982), Weintraub (Weintraub, 1986), and the
NOSGER (Spiegel et aI., 1991) were introduced for geriatric assessment or for clinical evaluation of patients
with AD, and include items that assess more complicated
activities (instrumental ADL, IADL). Some of these
scales contain gender-specific items or items performed
at infrequent intervals, such as filling out forms or documents. Others ask whether a subject "can" perform an
ADL rather than relying on purely observed activities,
which introduces judgment or opinion into the informant's report. Several scales combine both ADL and
behavioral information (Blessed et aI., 1968; Spiegel et
aI., 1991). Many IADL show a floor effect in AD, i.e.,
patients lose IADL very early in the course of dementia,
whereas basic ADL show a ceiling effect, with normal
performance until late in the course of AD (Spector et aI.,
1978). The approach of using loss of ADL or IADL as
milestones (Galasko et aI., 1995) is similar to that of the
Functional Assessment Scale (Reisberg, 1988) and is
best suited to clinical studies with long follow-up periods.
Performance ADL (PADL) scales require subjects to
perform ADL tasks in a structured setting using props
(Loewenstein et aI., 1992). Scoring is standardized and
can capture elements of performance such as sequencing,
initiation, and motivation. However, PADL scales cover
a relatively
small number of activities, are timeconsuming, and do not evaluate performance in the subjects' own home environments. In view of the limitations
of existing instruments for use in clinical trials, the Alzheimer's Disease Cooperative Study (ADCS) developed
a set of informant-based ADL.
METHODS
Development
of the Inventory
Alzheimer
Disorders,
Subjects
The ADCS study of instrument development for AD
clinical trials enrolled elderly controls (n = 64; 24 men
and 40 women) and subjects with AD (242 AD patients;
94 men and 148 women) as described (Ferris et aI., this
issue). Recruitment of subjects with AD was stratified by
Mini-Mental State Examination (MMSE; Folstein et aI.,
1975) scores at baseline, and all were communitydwelling at the time of enrollment in the study. All subjects were evaluated at baseline and at 6 and 12 months,
and half of the subjects were evaluated at 1 and 2
months. The present study made use of data at baseline,
1, 2, and 12 months.
Procedures
For each AD patient, an informant who spent at least
2 days per week with the patient was identified and in-
ADL INVENTORY
terviewed with the ADL Inventory. Controls acted as
their own informants. ADL interviews were conducted in
person at baseline. To increase follow-up participation, if
informants were unable to travel to a center's clinic site,
interviews were conducted by telephone. A representative from each participating center attended a training
se~sion at which use of the inventory was described, and
ea~h site received a procedural manual describing each
question in the ADL Inventory. The personnel who carried out ADL interviews were psychometrists or clinicians with experience in assessment of patients with AD.
The ADL Inventory took from 30 to 45 min to administer.
Data Analysis
Data were analyzed using SPSS (version 6.1). We
used several criteria to determine which ADL in the inventory were likely to be best suited for use in monitoring patients in clinical trials. These included wide applicability, good test-retest reliability, ability of the ADL to
show stepwise scaling and to correlate with dementia
severity, and decline of ADL performance in an appreciable percentage of patients with AD over 12 months
(Feinstein et aI., 1986; Streiner and Norman, 1995). Applicability was measured as the percentage of subjects
who attempted each ADL at baseline, or premorbidly in
the case of AD patients who did not attempt specific
ADL. As an index of short-term (test-retest) reliability
for each ADL, the extent of agreement between ratings at
baseline, one and two months was calculated using a K
statistic (O'Connell and Dobson, 1984). To determine
whether the levels of performing each ADL related to
dementia severity, we compared MMSE scores between
patients who carried out the ADL in each specified manner at baseline by ANOVA. If MMSE scores of patients
performing an ADL at different descriptors or "levels"
of ADL performance did not differ significantly (p
<0.05), we considered collapsing that ADL into fewer
descriptors. The overall correlations between ratings of
each ADL item and MMSE scores at baseline among AD
patients were analyzed using the Spearman rank-order
test. To assess whether ADL items showed long-term
change, we analyzed the proportion of subjects with AD
who declined on each ADL item at 12 months with respect to baseline. Change at 12 months was also broken
down for patients in each baseline MMSE stratum.
RESULTS
The demographic features and global test scores for
this cohort at baseline through 12 months have been
described (Ferris et aI., 1997, this issue). Control subjects
S35
Alzheimer
Disorders,
S36
D. GALASKO ET AL.
TABLE 1. Metric properties of selected ADL Inventory questions in patients with AD
Applicability: % of subjects
attempting ADL at baseline
By MMSE stratab
ADL question
(number of levelst
Handles mail (3)
Discusses current events (4)
Makes a snack or meal (5)
Writes note/letter/name (4)
Uses household appliance (4)C
Reads(4)
Hobby/pastime/game (3r
Chooses clothes to wear (3Y
Turns off lights (2)
Puts away belongings (4)C
Can be left alone (4)
Goes shopping (3)
Keeps appointments (4)
Obtainsa beverage(5)
Finds belongings (3)C
Clears a table (4)C
Disposes of litter (4)C
Makes conversation (4)
Grooms(5)
Gets dressed (5)
Bathes(5)
Uses a telephone (4)
Travelsoutsidehome(5)
Watches TV (5)
Toileting(4)
Walking(5)
Eating(5)
Overall
>20
30
44
50
51
53
54
56
56
60
61
62
63
70
70
71
71
73
75
75
75
77
80
90
92
92
97
97
Correlation
with MMSE
(K)
(Spearman R)
Overall
>20
16
10
..
..
..
..
..
..
..
..
..
0
..
0
..
..
10
0.41*
0.50**
22
..
.
.
.
1
1
1
1
0.51*
I
I
30
30
33
34
30
29
36
24
35
..
0.62*
0.59*
0.62*
0.45*
0.59*
0.59*
0.61*
0.45*
0.48**
0.55**
0.57**
0.61**
0.56**
0.44**
0.54**
0.44**
0.46**
0.55**
35
..
..
..
..
0.52*
0.48*
0.46*
..
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1
1
1
1
1
1
1
.
.1
.
1
1
1
1
1
1
1
1
1
..
..
I
I
1
1
1
I
1
1
1
1
.. 11
By MMSE stratab
16
Change at 12 months:
% of subjects who declined on ADL
Test-retest
reliability
1
1
. 11 1I
.. 11 II
.. 1. 1.
. . . .
. . . . .
. . . . .
. . . . .
.
..
..
0.54*
0.40*
0.60*
0.43*
0.41*
0.55*
0.55*
0.73*
0.50*
0.59*
0.45*
0.66*
0.45*
0.60*
0.47**
0.44**
0.61**
0.42**
0.45**
0.49**
0.40**
0.64**
0.66**
0.66**
0.70**
0.50**
0.44**
0.61**
0.28**
0.55**
36
35
40
37
32
35
35
35
42
40
47
44
34
37
0
0
0
..
0
0
0
0
..
..
0
0
0
0
0
0
0
..
0
..
0
..
..
..
..
..
..
..
..
..
0
0
..
..
..
..
..
..
..
0
0
0
0
0
0
0
..
..
..
..
..
..
..
..
..
..
..
... ....
..
..
..
. . 0
..
..
. ..
. . . ..
.
14
30
..
..
..
0
..
..
.
.
0
.
..
..
a ADL are arranged in ascending order according to the overall percentage of patients with AD who attempted the ADL at baseline.
b MMSE strata are as follows: >20, 20-28 points; 16,16-20; 10, 10-15; 5, 5-9; 0, 0-4. Symbols indicate the percentage of subjects in MMSE strata
who attempted each ADL at baseline: . >80%; 161-80%; 141-60%; 121-40%; blank 0-20%. Symbols for the percentage of subjects who declined
50%; .. 30-49%;
ADL descriptorshad the format "independently,""with supervision,"or "with physicalhelp." All other ADL had specificallyworded
Alzheimer
Disorders,
S37
ADL INVENTORY
TABLE 2. ADL with properties that did not meet specified criteria for assessment of ADL in clinical trials
Not attempted
by
10%
of subjects
ADL question
(number of levels)
Checkbook (4t
Laundry (4t
Cleans a room (4t
Sets a table (4)a
Waters plants (4)a
Makes a bed (4t
Takes medications
regularly (3)
Cleans up spills (4 t
Listens to radio (4)
Chooses food (2)
Participates in
group event (3)
Turns faucet on (2)
Turns faucet off (2)
Turns lights on (2)
Uses door key (2)
Uses names of
friends, relatives (2)
Aware of toileting
needs (2)
Follows I-step
instructions (4)
a
Weak correlation
with MMSE
Reliability
(K)
0.62
0.83
0.55
0.65 .
0.59
0.69
27%
15%
15%
19%
13%
38%
23%
10%
<20% of
subjects declined
at 12 months
Other'
+
+
+
+
+
0.57
0.24
0.38
0.53
+
+
+
+
+
0.43
0.63
0.75
0.69
0.86
+
+
+
Sev
Sev
Sev
0.65
+
0.14
0.44
Sev
Sev
ADL descriptors had the format "independently," "with supervision," or "with physical help." All other ADL had specifically worded
10
Alzheimer
Disorders,
S38
D. GALASKO ET AL.
'"0)
.S
U0)
'"
20
-B
15
is
....
0
....
0)
10
5
Z
0
Controls
21 - 30
16- 20
10- 15
5-9
Alzheimer
Disorders,
0-4